Automated matching software for clinical trials eligibility: measuring efficiency and flexibility.

PubMed

Penberthy, Lynne; Brown, Richard; Puma, Federico; Dahman, Bassam

2010-05-01

Clinical trials (CT) serve as the media that translates clinical research into standards of care. Low or slow recruitment leads to delays in delivery of new therapies to the public. Determination of eligibility in all patients is one of the most important factors to assure unbiased results from the clinical trials process and represents the first step in addressing the issue of under representation and equal access to clinical trials. This is a pilot project evaluating the efficiency, flexibility, and generalizibility of an automated clinical trials eligibility screening tool across 5 different clinical trials and clinical trial scenarios. There was a substantial total savings during the study period in research staff time spent in evaluating patients for eligibility ranging from 165h to 1329h. There was a marked enhancement in efficiency with the automated system for all but one study in the pilot. The ratio of mean staff time required per eligible patient identified ranged from 0.8 to 19.4 for the manual versus the automated process. The results of this study demonstrate that automation offers an opportunity to reduce the burden of the manual processes required for CT eligibility screening and to assure that all patients have an opportunity to be evaluated for participation in clinical trials as appropriate. The automated process greatly reduces the time spent on eligibility screening compared with the traditional manual process by effectively transferring the load of the eligibility assessment process to the computer. Copyright (c) 2010 Elsevier Inc. All rights reserved.

Assessing the Eligibility Criteria in Phase III Randomized Controlled Trials of Drug Therapy in Heart Failure With Preserved Ejection Fraction: The Critical Play-Off Between a "Pure" Patient Phenotype and the Generalizability of Trial Findings.

PubMed

Patel, Hitesh C; Hayward, Carl; Dungu, Jason N; Papadopoulou, Sofia; Saidmeerasah, Abdel; Ray, Robin; Di Mario, Carlo; Shanmugam, Nesan; Cowie, Martin R; Anderson, Lisa J

2017-07-01

To investigate the effect of the different eligibility criteria used by phase III clinical studies in heart failure with preserved ejection fraction (HFpEF) on patient selection, phenotype, and survival. We applied the key eligibility criteria of 7 phase III HFpEF studies (Digitalis Investigation Group Ancillary, Candesartan in Patients With Chronic Heart Failure and Preserved Left-Ventricular Ejection Fraction, Perindopril in Elderly People With Chronic Heart Failure, Irbesartan in Heart Failure With Preserved Systolic Function, Japanese Diastolic Heart Failure, Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist, and Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction [PARAGON-HF; ongoing]) to a typical and well-characterized HFpEF population (n = 557) seen in modern European cardiological practice. Follow-up was available for a minimum of 24 months in each patient. Increasing the number of study eligibility criteria identifies a progressively smaller group of patients from real-life practice suitable for recruitment into clinical trials; using the J-DHF criteria, 81% of our clinic patients would have been eligible, whereas the PARAGON-HF criteria significantly reduced this proportion to 32%. The patients identified from our clinical population had similar mortality rates using the different criteria, which were consistently higher than those reported in the actual clinic trials. Trial eligibility criteria have become stricter with time, which reduces the number of eligible patients, affecting both generalizability of any findings and feasibility of completing an adequately powered trial. We could not find evidence that the additional criteria used in more recent randomized trials in HFpEF have identified patients at higher risk of all-cause mortality. Copyright © 2017 Elsevier Inc. All rights reserved.

Evaluation of eligibility and recruitment in breast cancer clinical trials.

PubMed

Lemieux, Julie; Forget, Geneviève; Brochu, Olyvia; Provencher, Louise; Cantin, Guy; Desbiens, Christine; Doyle, Catherine; Poirier, Brigitte; Camden, Stéphanie; Durocher, Martin

2014-08-01

Objectives of the study were to measure recruitment rates in clinical trials and to identify patients, physicians or trials characteristics associated with higher recruitment rates. Among patients who had a clinical trial available for their cancer, 83.5% (345/413) met the eligibility criteria to at least one clinical trial. At least one trial was proposed to 33.1% (113/341) of the eligible patients and 19.7% (68/345) were recruited. Overall recruitment was 16.5% (68/413). In multivariate analyses, trial proposal and enrollment were lower for elderly patients and higher in high cancer stages. Trials from pharmaceutical industry had higher recruitment rates and trials testing hormonal therapy enrolled more patients. Breast cancer patients' accrual to a clinical trial could be improved by trying to systematically identify all eligible patients and propose a trial to those eligible and to whom the treatment is planned to be equivalent to the standard arm of the trial. Copyright © 2014 Elsevier Ltd. All rights reserved.

Linking the Congenital Heart Surgery Databases of the Society of Thoracic Surgeons and the Congenital Heart Surgeons’ Society: Part 1—Rationale and Methodology

PubMed Central

Jacobs, Jeffrey P.; Pasquali, Sara K.; Austin, Erle; Gaynor, J. William; Backer, Carl; Hirsch-Romano, Jennifer C.; Williams, William G.; Caldarone, Christopher A.; McCrindle, Brian W.; Graham, Karen E.; Dokholyan, Rachel S.; Shook, Gregory J.; Poteat, Jennifer; Baxi, Maulik V.; Karamlou, Tara; Blackstone, Eugene H.; Mavroudis, Constantine; Mayer, John E.; Jonas, Richard A.; Jacobs, Marshall L.

2014-01-01

Purpose The Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD) is the largest Registry in the world of patients who have undergone congenital and pediatric cardiac surgical operations. The Congenital Heart Surgeons’ Society Database (CHSS-D) is an Academic Database designed for specialized detailed analyses of specific congenital cardiac malformations and related treatment strategies. The goal of this project was to create a link between the STS-CHSD and the CHSS-D in order to facilitate studies not possible using either individual database alone and to help identify patients who are potentially eligible for enrollment in CHSS studies. Methods Centers were classified on the basis of participation in the STS-CHSD, the CHSS-D, or both. Five matrices, based on CHSS inclusionary criteria and STS-CHSD codes, were created to facilitate the automated identification of patients in the STS-CHSD who meet eligibility criteria for the five active CHSS studies. The matrices were evaluated with a manual adjudication process and were iteratively refined. The sensitivity and specificity of the original matrices and the refined matrices were assessed. Results In January 2012, a total of 100 centers participated in the STS-CHSD and 74 centers participated in the CHSS. A total of 70 centers participate in both and 40 of these 70 agreed to participate in this linkage project. The manual adjudication process and the refinement of the matrices resulted in an increase in the sensitivity of the matrices from 93% to 100% and an increase in the specificity of the matrices from 94% to 98%. Conclusion Matrices were created to facilitate the automated identification of patients potentially eligible for the five active CHSS studies using the STS-CHSD. These matrices have a sensitivity of 100% and a specificity of 98%. In addition to facilitating identification of patients potentially eligible for enrollment in CHSS studies, these matrices will allow (1) estimation of the denominator of patients potentially eligible for CHSS studies and (2) comparison of eligible and enrolled patients to potentially eligible and not enrolled patients to assess the generalizability of CHSS studies. PMID:24668974

A Prospective Study of the Utility of Magnetic Resonance Imaging in Determining Candidacy for Partial Breast Irradiation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dorn, Paige L.; Al-Hallaq, Hania A.; Haq, Farah

2013-03-01

Purpose: Retrospective data have demonstrated that breast magnetic resonance imaging (MRI) may change a patient's eligibility for partial breast irradiation (PBI) by identifying multicentric, multifocal, or contralateral disease. The objective of the current study was to prospectively determine the frequency with which MRI identifies occult disease and to establish clinical factors associated with a higher likelihood of MRI prompting changes in PBI eligibility. Methods and Materials: At The University of Chicago, women with breast cancer uniformly undergo MRI in addition to mammography and ultrasonography. From June 2009 through May 2011, all patients were screened prospectively in a multidisciplinary conference formore » PBI eligibility based on standard imaging, and the impact of MRI on PBI eligibility according to National Surgical Adjuvant Breast and Bowel Project protocol B-39/Radiation Therapy Oncology Group protocol 0413 entry criteria was recorded. Univariable analysis was performed using clinical characteristics in both the prospective cohort and in a separate cohort of retrospectively identified patients. Pooled analysis was used to derive a scoring index predictive of the risk that MRI would identify additional disease. Results: A total of 521 patients were screened for PBI eligibility, and 124 (23.8%) patients were deemed eligible for PBI based on standard imaging. MRI findings changed PBI eligibility in 12.9% of patients. In the pooled univariable analysis, tumor size ≥2 cm on mammography or ultrasonography (P=.02), age <50 years (P=.01), invasive lobular histology (P=.01), and HER-2/neu amplification (P=.01) were associated with a higher likelihood of MRI changing PBI eligibility. A predictive score was generated by summing the number of significant risk factors. Patients with a score of 0, 1, 2, and 3 had changes to eligibility based on MRI findings in 2.8%, 13.2%, 38.1%, and 100%, respectively (P<.0001). Conclusions: MRI identified additional disease in a significant number of patients eligible for PBI, based on standard imaging. Clinical characteristics may be useful in directing implementation of MRI in the staging of PBI candidates.« less

Differences in clinical outcome between docetaxel and abiraterone acetate as the first-line treatment in chemo-naïve metastatic castration-resistant prostate cancer patients with or without the ineligible clinical factors of the COU-AA-302 study.

PubMed

Poon, Darren M C; Chan, Kuen; Lee, Siu H; Chan, Tim W; Sze, Henry; Lee, Eric K C; Lam, Daisy; Chan, Michelle F T

2018-03-01

This study aimed to compare the efficacy of abiraterone acetate (AA) versus docetaxel (T) as first-line treatment in chemo-naïve metastatic castration-resistant prostate cancer (mCRPC) patients with or without the ineligible factors of the COU-AA-302 study (presence of visceral metastases, symptomatic disease, and/or Eastern Cooperative Oncology Group performance status ≥ 2). The clinical records of chemo-naïve mCRPC patients who received AA in six public oncology centers or T in two of these centers between 2003 and 2014 were reviewed. The survival time was compared among four subgroups of patients: those with ineligible factors administered AA (Group Ineligible-AA) or T (Group Ineligible-T), and those without ineligible factors and administered AA (Group Eligible-AA) or T (Group Eligible-T). During the study period, we identified 115 mCRPC patients who received AA or T, among whom 29, 36, 29, and 21 patients were classified as Groups Ineligible-AA, Ineligible-T, Eligible-AA, and Eligible-T, respectively. Both Group Ineligible-AA and Group Eligible-AA had significantly longer progression-free survival (PFS) and similar overall survival (OS) as Group Ineligible-T and Group Eligible-T (Ineligible, PFS: 6.3 vs. 5.9 months, P  = 0.0234, OS: 7.8 vs. 15.7 months, P  = 0.1601; Eligible, PFS: 9.8 vs. 5.6 months, P  = 0.0437, OS: 20.5 vs. 18.2 months, P  = 0.7820). Compared to T, AA treatment resulted in longer PFS and similar OS in chemo-naïve mCRPC patients, irrespective of the presence of ineligible factors, suggesting that the initial treatment by AA may still be beneficial to those with the aforementioned ineligible factors.

The Data Gap in the EHR for Clinical Research Eligibility Screening.

PubMed

Butler, Alex; Wei, Wei; Yuan, Chi; Kang, Tian; Si, Yuqi; Weng, Chunhua

2018-01-01

Much effort has been devoted to leverage EHR data for matching patients into clinical trials. However, EHRs may not contain all important data elements for clinical research eligibility screening. To better design research-friendly EHRs, an important step is to identify data elements frequently used for eligibility screening but not yet available in EHRs. This study fills this knowledge gap. Using the Alzheimer's disease domain as an example, we performed text mining on the eligibility criteria text in Clinicaltrials.gov to identify frequently used eligibility criteria concepts. We compared them to the EHR data elements of a cohort of Alzheimer's Disease patients to assess the data gap by usingthe OMOP Common Data Model to standardize the representations for both criteria concepts and EHR data elements. We identified the most common SNOMED CT concepts used in Alzheimer 's Disease trials, andfound 40% of common eligibility criteria concepts were not even defined in the concept space in the EHR dataset for a cohort of Alzheimer 'sDisease patients, indicating a significant data gap may impede EHR-based eligibility screening. The results of this study can be useful for designing targeted research data collection forms to help fill the data gap in the EHR.

PROSPECT Eligibility and Clinical Outcomes: Results From the Pan-Canadian Rectal Cancer Consortium.

PubMed

Bossé, Dominick; Mercer, Jamison; Raissouni, Soundouss; Dennis, Kristopher; Goodwin, Rachel; Jiang, Di; Powell, Erin; Kumar, Aalok; Lee-Ying, Richard; Price-Hiller, Julie; Heng, Daniel Y C; Tang, Patricia A; MacLean, Anthony; Cheung, Winson Y; Vickers, Michael M

2016-09-01

The PROSPECT trial (N1048) is evaluating the selective use of chemoradiation in patients with cT2N1 and cT3N0-1 rectal cancer undergoing sphincter-sparing low anterior resection. We evaluated outcomes of PROSPECT-eligible and -ineligible patients from a multi-institutional database. Data from patients with locally advanced rectal cancer who received chemoradiation and low anterior resection from 2005 to 2014 were retrospectively collected from 5 Canadian centers. Overall survival, disease-free survival (DFS), recurrence-free survival (RFS), and time to local recurrence (LR) were estimated using the Kaplan-Meier method, and a multivariate analysis was performed adjusting for prognostic factors. A total of 566 (37%) of 1531 patients met the PROSPECT eligibility criteria. Eligible patients were more likely to have better PS (P = .0003) and negative circumferential resection margin (P < .0001). PROSPECT eligibility was associated with improved DFS (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.61-0.91), overall survival (HR, 0.73; 95% CI, 0.57-0.95), and RFS (HR, 0.68; 95% CI, 0.54-0.86) in univariate analyses. In multivariate analysis, only RFS remained significantly improved for PROSPECT-eligible patients (HR, 0.75; 95% CI, 0.57-1.00, P = .0499). The 3-year DFS and freedom from LR for PROSPECT-eligible patients were 79.1% and 97.4%, respectively, compared to 71.1% and 96.8% for PROSPECT-ineligible patients. Real-world data corroborate the eligibility criteria used in the PROSPECT study; the criteria identify a subgroup of patients in whom risk of recurrence is lower and in whom selective use of chemoradiation should be actively examined. Copyright © 2016 Elsevier Inc. All rights reserved.

The Prevalence of Japanese Outpatients with Hypertension Who Meet the Definition of Treatment Resistant Hypertension and Are Eligible for Enrolment in Clinical Trials of Endovascular Ultrasound Renal Denervation.

PubMed

Okamura, Keisuke; Shirai, Kazuyuki; Okuda, Tetsu; Urata, Hidenori

2018-01-01

Objective A clinical trial (REQUIRE) was started to investigate the use of an ultrasound renal denervation system in the treatment of resistant hypertension (RHT). We analyzed the prevalence of patients who were eligible for inclusion in this cross-sectional study at the time of screening. Methods Nine-hundred ninety-nine consecutive hypertension (HT) patients who were treated in our hospital as outpatients were classified into the following categories: patients treated with at least 3 types of antihypertensive drugs including diuretic agents who were eligible for enrolment in SYMPLICITY HTN-Japan (SH-J) with an office systolic blood pressure (SBP) of ≥160 mmHg, who were ≤80 years of age, and an estimated glomerular filtration rate (eGFR) of ≥45 mL/min/1.73 m 2 (RHT-S); and patients who were treated similar medications and who were eligible for enrolment in REQUIRE, with an SBP of ≥150 mmHg, ≤75 years of age, and an eGFR of ≥40 mL/min/1.73 m 2 (RHT-R). We investigated the proportion of patients in each category. We also investigated HT patients (1,423 cases) who were enrolled in the Chikushi Anti-Hypertension Trial (CHAT), a research network that includes general practitioners. Results Eleven patients (1.1%) with RHT-S and 18 patients (1.8%) with RHT-R were identified. After the exclusion of patients with secondary HT and a diastolic blood pressure (DBP) of <90 mmHg (applied in REQUIRE), 5 patients (0.5%) with RHT-S and 4 patients (0.4%) with RHT-R remained. In the analysis of the CHAT study, only 2 (0.1%) patients with RHT-R remained. Conclusion The number of eligible patients in the REQUIRE trial was decreased, largely due to the strict age restriction and the new DBP limitation. The prevalence of eligible patients in REQUIRE was estimated to be approximately 0.5 to 0.8 times that in SH-J. Since patient enrollment will be difficult, drastic measures may be required to recruit eligible patients.

Racial and ethnic disparities in meeting MTM eligibility criteria among patients with asthma.

PubMed

Lu, Degan; Qiao, Yanru; Johnson, Karen C; Wang, Junling

2017-06-01

Asthma is one of the most frequently targeted chronic diseases in the medication therapy management (MTM) programs of the Medicare prescription drug (Part D) benefits. Although racial and ethnic disparities in meeting eligibility criteria for MTM services have been reported, little is known about whether there would be similar disparities among adults with asthma in the United States. Adult patients with asthma (age ≥ 18) from Medical Expenditure Panel Survey (2011-2012) were analyzed. Bivariate analyses were conducted to compare the proportions of patients who would meet Medicare MTM eligibility criteria between non-Hispanic Blacks (Blacks), Hispanics and non-Hispanic Whites (Whites). Survey-weighted logistic regression was performed to adjust for patient characteristics. Main and sensitivity analyses were conducted to cover the entire range of the eligibility thresholds used by Part D plans in 2011-2012. The sample included 4,455 patients with asthma, including 2,294 Whites, 1,218 Blacks, and 943 Hispanics. Blacks and Hispanics had lower proportions of meeting MTM eligibility criteria than did Whites (P < 0.001). According to the main analysis, Blacks and Hispanics had 36% and 32% lower, respectively, likelihood of MTM eligibility than Whites (odds ratio [OR]: 0.64, 95% confidence interval [CI]: 0.45-0.90; OR: 0.68, 95% CI: 0.47-0.98, respectively). Similar results were obtained in sensitivity analyses. There are racial and ethnic disparities in meeting Medicare Part D MTM eligibility criteria among adult patients with asthma. Future studies should examine the implications of such disparities on health outcomes of patients with asthma and explore alternative MTM eligibility criteria.

A pragmatic method for electronic medical record-based observational studies: developing an electronic medical records retrieval system for clinical research

PubMed Central

Yamamoto, Keiichi; Sumi, Eriko; Yamazaki, Toru; Asai, Keita; Yamori, Masashi; Teramukai, Satoshi; Bessho, Kazuhisa; Yokode, Masayuki; Fukushima, Masanori

2012-01-01

Objective The use of electronic medical record (EMR) data is necessary to improve clinical research efficiency. However, it is not easy to identify patients who meet research eligibility criteria and collect the necessary information from EMRs because the data collection process must integrate various techniques, including the development of a data warehouse and translation of eligibility criteria into computable criteria. This research aimed to demonstrate an electronic medical records retrieval system (ERS) and an example of a hospital-based cohort study that identified both patients and exposure with an ERS. We also evaluated the feasibility and usefulness of the method. Design The system was developed and evaluated. Participants In total, 800 000 cases of clinical information stored in EMRs at our hospital were used. Primary and secondary outcome measures The feasibility and usefulness of the ERS, the method to convert text from eligible criteria to computable criteria, and a confirmation method to increase research data accuracy. Results To comprehensively and efficiently collect information from patients participating in clinical research, we developed an ERS. To create the ERS database, we designed a multidimensional data model optimised for patient identification. We also devised practical methods to translate narrative eligibility criteria into computable parameters. We applied the system to an actual hospital-based cohort study performed at our hospital and converted the test results into computable criteria. Based on this information, we identified eligible patients and extracted data necessary for confirmation by our investigators and for statistical analyses with our ERS. Conclusions We propose a pragmatic methodology to identify patients from EMRs who meet clinical research eligibility criteria. Our ERS allowed for the efficient collection of information on the eligibility of a given patient, reduced the labour required from the investigators and improved the reliability of the results. PMID:23117567

Depression severity and quality of life of qualified and unqualified patients with a mood disorder for a research study targeting anhedonia in a clinical sample.

PubMed

Gao, Keming; Sweet, Jennifer; Su, Meilei; Calabrese, Joseph R

2017-06-01

To investigate the depression severity and quality of life of qualified and unqualified patients with a mood disorder for a research study based on anhedonia severity. Diagnosis of major depressive disorder (MDD) or bipolar disorder (BPD) was ascertained with the MINI International Neuropsychiatric Interview. The severity of depression was measured with the 16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-16-SR), and Item 5, "feeling sad (sadness)," QIDS-16-SR Item 13, "change in general interest," was used to measure the severity of anhedonia. The quality of life was measured with the Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q). Of 96 patients with MDD and 147 with bipolar I or II disorder, the severity rating on sadness and anhedonia was similar. The severities of anhedonia and sadness were highly correlated with R 2 of ≥0.91. Without considering depressive severity, 55% of patients would be eligible for a study if≥mild anhedonia was used as a severity criterion, but only 26% of patients eligible for a study if≥moderate anhedonia was used without considering substance use and medical comorbidities. If patients with ≥ moderate overall depressive symptoms were considered, 88.1% of patients would be eligible if≥mild anhedonia was required for a study, and 45.2% of patients would be eligible for a study if≥moderate anhedonia was required. For those who were unqualified for the study based on≥moderate anhedonia, about 1/3 had≥moderate overall depressive symptoms and less than 40% of maximum possible scores of Q-LES-Q. If only patients in remission based on overall depressive symptom severity were considered for a study of anhedonia, no patient would be eligible for the study. Depressive mood and anhedonia are highly correlated. Screening patients with a mood disorder and an overall moderate depressive severity is a cost-effective approach for a study targeting anhedonia, especially for a study requiring≥moderate severity of anhedonia. However, 1/3 of the unqualified patients will have≥moderate overall depressive symptoms and poor quality of life. Copyright © 2017 Elsevier B.V. All rights reserved.

Computerized patient identification for the EMBRACA clinical trial using real-time data from the PRAEGNANT network for metastatic breast cancer patients.

PubMed

Hein, Alexander; Gass, Paul; Walter, Christina Barbara; Taran, Florin-Andrei; Hartkopf, Andreas; Overkamp, Friedrich; Kolberg, Hans-Christian; Hadji, Peyman; Tesch, Hans; Ettl, Johannes; Wuerstlein, Rachel; Lounsbury, Debra; Lux, Michael P; Lüftner, Diana; Wallwiener, Markus; Müller, Volkmar; Belleville, Erik; Janni, Wolfgang; Fehm, Tanja N; Wallwiener, Diethelm; Ganslandt, Thomas; Ruebner, Matthias; Beckmann, Matthias W; Schneeweiss, Andreas; Fasching, Peter A; Brucker, Sara Y

2016-07-01

As breast cancer is a diverse disease, clinical trials are becoming increasingly diversified and are consequently being conducted in very small subgroups of patients, making study recruitment increasingly difficult. The aim of this study was to assess the use of data from a remote data entry system that serves a large national registry for metastatic breast cancer. The PRAEGNANT network is a real-time registry with an integrated biomaterials bank that was designed as a scientific study and as a means of identifying patients who are eligible for clinical trials, based on clinical and molecular information. Here, we report on the automated use of the clinical data documented to identify patients for a clinical trial (EMBRACA) for patients with metastatic breast cancer. The patients' charts were assessed by two independent physicians involved in the clinical trial and also by a computer program that tested patients for eligibility using a structured query language script. In all, 326 patients from two study sites in the PRAEGNANT network were included in the analysis. Using expert assessment, 120 of the 326 patients (37 %) appeared to be eligible for inclusion in the EMBRACA study; with the computer algorithm assessment, a total of 129 appeared to be eligible. The sensitivity of the computer algorithm was 0.87 and its specificity was 0.88. Using computer-based identification of patients for clinical trials appears feasible. With the instrument's high specificity, its application in a large cohort of patients appears to be feasible, and the workload for reassessing the patients is limited.

Implementation of a Telephone Postoperative Clinic in an Integrated Health System.

PubMed

Kummerow Broman, Kristy; Roumie, Christianne L; Stewart, Melissa K; Castellanos, Jason A; Tarpley, John L; Dittus, Robert S; Pierce, Richard A

2016-10-01

Earlier work suggested that telephone follow-up could be used in lieu of in-person follow-up after surgery, saving patients time and travel and maximizing use of scarce surgeon and facility resources. We report our experience implementing and evaluating telephone postoperative follow-up within an integrated health system. We conducted a pre-post evaluation of a general surgery telephone postoperative clinic at a tertiary care Veterans Affairs facility from April 2015 to February 2016. Patients were offered a telephone postoperative visit from a surgical provider in lieu of an in-person clinic visit. Telephone clinic operating procedures were refined through iterative cycles of change using the Plan-Do-Study-Act method. The study period included 2 months pre-intervention and 9 months post-intervention. The primary end point was mean number of clinic visits per eligible patient before and after telephone clinic implementation. Secondary outcomes were rates of emergency department visits and readmissions before vs after telephone clinic implementation and complication rates in patients scheduled for telephone vs in-person postoperative care. During the study period, 200 patients underwent eligible operations, 29 pre-intervention and 171 post-intervention. In-person clinic use decreased from 0.83 visits per eligible patient pre-intervention to 0.40 after implementation of the telephone clinic (p < 0.01). There was no difference in rates of emergency department presentation or readmission in eligible patients (0.17 visits/patient pre-intervention vs 0.12 post-intervention; p = 0.36). Complication rates were comparable for eligible patients who were and were not scheduled for telephone care (6% vs 8%; p = 0.31). Telephone postoperative care can be used in select populations as a triage tool to identify patients who require in-person care and decrease overall in-person clinic use. Published by Elsevier Inc.

A Screening Tool to Enhance Clinical Trial Participation at a Community Center Involved in a Radiation Oncology Disparities Program

PubMed Central

Proctor, Julian W.; Martz, Elaine; Schenken, Larry L.; Rainville, Rebecca; Marlowe, Ursula

2011-01-01

Purpose: To investigate the effectiveness of a screening tool to enhance clinical trial participation at a community radiation oncology center involved in a National Cancer Institute–funded disparities program but lacking on-site clinical trials personnel. Patients and Methods: The screening form was pasted to the front of the charts and filled out for all new patients over the 9-month period of the study, during which time five external beam radiation therapy (EBRT) trials and a patient perception study were open for accrual. Patient consent was obtained by assorted personnel at several different sites. Patients potentially eligible for a trial were identified and approached by one of the clinic staff. Patients who were under- or uninsured, age > 80 years, members of an racial/ethnic minority, or recipients of medical assistance were identified as at risk for health care disparities and were offered patient navigator services. Results: Of 196 patients consulted during the study, 144 were treated with EBRT. Of the 24 patients eligible for EBRT trials, 23 were approached (one had an incomplete screening form), and 15 accepted. Of 77 patients eligible for a patient perception trial, 72 were approached (five had incomplete forms), and 45 accepted. The eligibility and acceptance rates for EBRT trials were similar for disparities and nondisparities patients. Screening was completed for 96 patients (67%). Conclusion: When completed, the screening tool ensured clinical trial accrual. The major factor limiting overall accrual was a shortage of available trials. PMID:21886496

Induction regimens for transplant-eligible patients with newly diagnosed multiple myeloma: a network meta-analysis of randomized controlled trials

PubMed Central

Zeng, Zi-Hang; Chen, Jia-Feng; Li, Yi-Xuan; Zhang, Ran; Xiao, Ling-Fei; Meng, Xiang-Yu

2017-01-01

Objective The aim of this study was to compare the early efficacy and survivals of induction regimens for transplant-eligible patients with untreated multiple myeloma. Materials and methods A comprehensive literature search in electronic databases was conducted for relevant randomized controlled trials (RCTs). Eligible studies were selected according to the predefined selection criteria, before they were evaluated for methodological quality. Basic characteristics and data for network meta-analysis (NMA) were extracted from included trials and pooled in our meta-analysis. The end points were the overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Results A total of 14 RCTs that included 4,763 patients were analyzed. The post-induction ORR was higher with bortezomib plus thalidomide plus dexamethasone (VTD) regimens, and VTD was better than the majority of other regimens. For OS, VTD plus cyclophosphamide (VTDC) regimens showed potential superiority over other regimens, but the difference was not statistically significant. The PFS was longer with thalidomide plus doxorubicin plus dexamethasone (TAD) regimens for transplant-eligible patients with newly diagnosed multiple myeloma (NDMM). Conclusion The NMA demonstrated that the VTD, VTDC, and TAD regimens are most beneficial in terms of ORR, OS, and PFS for transplant-eligible patients with NDMM, respectively. PMID:28744159

Clinical outcomes of HIV care delivery models in the US: a systematic review.

PubMed

Kimmel, April D; Martin, Erika G; Galadima, Hadiza; Bono, Rose S; Tehrani, Ali Bonakdar; Cyrus, John W; Henderson, Margaret; Freedberg, Kenneth A; Krist, Alexander H

2016-10-01

With over 1 million people living with HIV, the US faces national challenges in HIV care delivery due to an inadequate HIV specialist workforce and the increasing role of non-communicable chronic diseases in driving morbidity and mortality in HIV-infected patients. Alternative HIV care delivery models, which include substantial roles for advanced practitioners and/or coordination between specialty and primary care settings in managing HIV-infected patients, may address these needs. We aimed to systematically review the evidence on patient-level HIV-specific and primary care health outcomes for HIV-infected adults receiving outpatient care across HIV care delivery models. We identified randomized trials and observational studies from bibliographic and other databases through March 2016. Eligible studies met pre-specified eligibility criteria including on care delivery models and patient-level health outcomes. We considered all available evidence, including non-experimental studies, and evaluated studies for risk of bias. We identified 3605 studies, of which 13 met eligibility criteria. Of the 13 eligible studies, the majority evaluated specialty-based care (9 studies). Across all studies and care delivery models, eligible studies primarily reported mortality and antiretroviral use, with specialty-based care associated with mortality reductions at the clinician and practice levels and with increased antiretroviral initiation or use at the clinician level but not the practice level. Limited and heterogeneous outcomes were reported for other patient-level HIV-specific outcomes (e.g., viral suppression) as well as for primary care health outcomes across all care delivery models. No studies addressed chronic care outcomes related to aging. Limited evidence was available across geographic settings and key populations. As re-design of care delivery in the US continues to evolve, better understanding of patient-level HIV-related and primary care health outcomes, especially across different staffing models and among different patient populations and geographic locations, is urgently needed to improve HIV disease management.

A screening tool to enhance clinical trial participation at a community center involved in a radiation oncology disparities program.

PubMed

Proctor, Julian W; Martz, Elaine; Schenken, Larry L; Rainville, Rebecca; Marlowe, Ursula

2011-05-01

To investigate the effectiveness of a screening tool to enhance clinical trial participation at a community radiation oncology center involved in a National Cancer Institute-funded disparities program but lacking on-site clinical trials personnel. The screening form was pasted to the front of the charts and filled out for all new patients over the 9-month period of the study, during which time five external beam radiation therapy (EBRT) trials and a patient perception study were open for accrual. Patient consent was obtained by assorted personnel at several different sites. Patients potentially eligible for a trial were identified and approached by one of the clinic staff. Patients who were under- or uninsured, age > 80 years, members of an racial/ethnic minority, or recipients of medical assistance were identified as at risk for health care disparities and were offered patient navigator services. Of 196 patients consulted during the study, 144 were treated with EBRT. Of the 24 patients eligible for EBRT trials, 23 were approached (one had an incomplete screening form), and 15 accepted. Of 77 patients eligible for a patient perception trial, 72 were approached (five had incomplete forms), and 45 accepted. The eligibility and acceptance rates for EBRT trials were similar for disparities and nondisparities patients. Screening was completed for 96 patients (67%). When completed, the screening tool ensured clinical trial accrual. The major factor limiting overall accrual was a shortage of available trials.

Efficacy and effectiveness of tumour necrosis factor inhibitors in the treatment of rheumatoid arthritis in randomized controlled trials and routine clinical practice.

PubMed

Aaltonen, Kalle J; Ylikylä, Suvi; Tuulikki Joensuu, Jaana; Isomäki, Pia; Pirilä, Laura; Kauppi, Markku; Rannio, Tuomas; Eklund, Kari; Blom, Marja; Nordström, Dan

2017-05-01

Efficacy of TNF inhibitors in the treatment of RA assessed in randomized controlled trials (RCTs) may not be fully comparable to routine care owing to the stringent inclusion criteria. The objective of this study was to observe the effectiveness of TNF inhibitors in real-world patients and assess the patients' potential eligibility for the RCTs. RA patients starting a TNF-inhibitor treatment between 2004 and 2014 were identified from the National Register for Biologic Treatment in Finland, which is a longitudinal observational cohort study. Effectiveness was measured using the ACR and EULAR response criteria and by studying the proportion of patients reaching DAS28 remission. The patients' baseline characteristics were compared against the inclusion criteria of 27 RCTs. EULAR moderate and good treatment responses at 6 months were achieved by 69 and 40% of the users of the first TNF inhibitor, respectively. ACR20, ACR50 and ACR70 responses were reached by 48, 27 and 13%, respectively. DAS28 remission was reached by 47%. Only 7.6-44% of the patients would have been potentially eligible for the RCTs. The eligible patients had better treatment responses compared with the non-eligible patients. Different TNF inhibitors were mostly equipotent, but the usage of MTX co-therapy had a major influence on treatment response. Only a small proportion of patients would have been eligible for RCTs, and the efficacy of TNF inhibitors assessed in them cannot be generalized directly into Finnish routine health care. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

No Difference in Effectiveness of 8 vs 12 Weeks of Ledipasvir and Sofosbuvir for Treatment of Hepatitis C in Black Patients.

PubMed

Marcus, Julia L; Hurley, Leo B; Chamberland, Scott; Champsi, Jamila H; Gittleman, Laura C; Korn, Daniel G; Lai, Jennifer B; Lam, Jennifer O; Pauly, Mary Patricia; Quesenberry, Charles P; Ready, Joanna; Saxena, Varun; Seo, Suk I; Witt, David J; Silverberg, Michael J

2018-06-01

Treatment with the combination of ledipasvir and sofosbuvir for 12 weeks has been approved by the Food and Drug Administration for patients with genotype 1 hepatitis C virus (HCV) infection; some patients can be treated with an 8-week course. Guidelines recommend a 12-week treatment course for black patients, but studies have not compared the effectiveness of 8 vs 12 weeks in black patients who are otherwise eligible for an 8-week treatment regimen. We conducted an observational study of Kaiser Permanente Northern California members with HCV genotype 1 infection who were eligible for 8 weeks of treatment with ledipasvir and sofosbuvir (treatment-naïve, no cirrhosis, no HIV infection, level of HCV RNA <6 million IU/mL) and were treated for 8 or 12 weeks from October 2014 through December 2016. We used χ 2 analyses to compare sustained virologic response 12 weeks after the end of treatment (SVR12) among patients treated for 8 vs 12 weeks, and adjusted Poisson models to identify factors associated with receipt of 12 weeks of therapy among patients eligible for 8 weeks. Of 2653 patients eligible for 8 weeks of treatment with ledipasvir and sofosbuvir, 1958 (73.8%) received 8 weeks of treatment and 695 (26.2%) received 12 weeks; the proportions of patients with SVR12 were 96.3% and 96.3%, respectively (P = .94). Among 435 black patients eligible for the 8-week treatment regimen, there was no difference in the proportions who achieved an SVR12 following 8 vs 12 weeks' treatment (95.6% vs 95.8%; P = .90). Male sex, higher transient elastography or FIB-4 scores, higher INR and level of bilirubin, lower level of albumin, obesity, diabetes, and ≥15 alcohol drinks consumed/week were independently associated with receiving 12 weeks of treatment among patients eligible for the 8-week treatment regimen, but were not associated with reduced SVR12 after 8 weeks of treatment. In an observational study of patients who received ledipasvir and sofosbuvir treatment for HCV genotype 1 infection, we found that contrary to guidelines, 8-week and 12-week treatment regimens do not result in statistically significant differences in SVR12 in black patients. Patient characteristics were associated with receipt of 12-week regimens among patients eligible for 8 weeks, but were not associated with reduced SVR12 after 8 weeks. Shorter treatment courses might therefore be more widely used without compromising treatment effectiveness. Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.

Provider reported barriers and solutions to improve testing among tuberculosis patients ‘eligible for drug susceptibility test’: A qualitative study from programmatic setting in India

PubMed Central

Parmar, Malik; Verma, Manoj; Desikan, Prabha; Khan, Sheeba Naz; Kumar, Ajay M. V.

2018-01-01

Background In a study conducted in Bhopal district (a setting with facility for molecular drug susceptibility testing (DST)) located in central India in 2014–15, we found high levels of pre-diagnosis attrition among patients with presumptive multi drug-resistant tuberculosis (MDR-TB)–meaning TB patients who were eligible for DST, were not being tested. Objectives In this study, we explored the health care provider perspectives into barriers and suggested solutions for improving DST. Methods This was a descriptive qualitative study. One to one interviews (n = 10) and focus group discussions (n = 2) with experienced key informants involved in programmatic management of DR-TB were conducted in April 2017. Manual descriptive thematic analysis was performed. Results The key barriers reported were a) lack of or delay in identification of patients eligible for DST because of using treatment register as the source for identifying patients b) lack of assured specimen transport after patient identification and c) lack of tracking. Extra pulmonary TB patients were not getting identified as eligible for DST. Solutions suggested by the health care providers were i) generation of unique identifier at identification in designated microscopy center (DMC), immediate intimation of unique identifier to district and regular monitoring by senior TB laboratory and senior treatment supervisors of patients eligible for DST that were missed; ii) documentation of unique identifier at each step of cascade; iii) use of human carriers/couriers to transport specimen from DMCs especially in rural areas; and iv) routine entry of all presumptive extra-pulmonary TB specimen, as far as possible, in DMC laboratory register. Conclusion Lack of assured specimen transport and lack of accountability for tracking patient after identification and referral were the key barriers. The identification of patients eligible for DST among microbiologically confirmed TB at the time of diagnosis and among clinically confirmed TB at the time of treatment initiation is the key. Use of unique identifier at identification and its use to ensure cohort wise tracking has to be complemented with specimen transport support and prompt feedback to the DMC. The study has implications to improve detection of MDR-TB among diagnosed/notified TB patients. PMID:29677210

Fitness for entering a simple exercise program and mortality: a study corollary to the exercise introduction to enhance performance in dialysis (EXCITE) trial.

PubMed

Baggetta, Rossella; Bolignano, Davide; Torino, Claudia; Manfredini, Fabio; Aucella, Filippo; Barillà, Antonio; Battaglia, Yuri; Bertoli, Silvio; Bonanno, Graziella; Castellino, Pietro; Ciurlino, Daniele; Cupisti, Adamasco; D'Arrigo, Graziella; De Paola, Luciano; Fabrizi, Fabrizio; Fatuzzo, Pasquale; Fuiano, Giorgio; Lombardi, Luigi; Lucisano, Gaetano; Messa, Piergiorgio; Rapanà, Renato; Rapisarda, Francesco; Rastelli, Stefania; Rocca-Rey, Lisa; Summaria, Chiara; Zuccalà, Alessandro; Abd ElHafeez, Samar; Tripepi, Giovanni; Catizone, Luigi; Mallamaci, Francesca; Zoccali, Carmine

2014-01-01

In this corollary analysis of the EXCITE study, we looked at possible differences in baseline risk factors and mortality between subjects excluded from the trial because non-eligible (n=216) or because eligible but refusing to participate (n=116). Baseline characteristics and mortality data were recorded. Survival and independent predictors of mortality were assessed by Kaplan-Meier and Cox regression analyses. The incidence rate of mortality was higher in non-eligible vs. eligible non-randomized patients (21.0 vs. 10.9 deaths/100 persons-year; P<0.001). The crude excess risk of death in non-eligible patients (HR 1.96; 95% CI 1.36 to 2.77; P<0.001) was reduced after adjustment for risk factors which differed in the two cohorts including age, blood pressure, phosphate, CRP, smoking, diabetes, triglycerides, cardiovascular comorbidities and history of neoplasia (HR 1.60; 95% CI 1.10 to 2.35; P=0.017) and almost nullified after including in the same model also information on deambulation impairment (HR 1.16; 95% CI 0.75 to 1.80; P=0.513). Deambulation ability mostly explains the difference in survival rate in non-eligible and eligible non-randomized patients in the EXCITE trial. Extending data analyses and outcome reporting also to subjects not taking part in a trial may be helpful to assess the representability of the study population. © 2014 S. Karger AG, Basel.

Patient factors associated with lung transplant referral and waitlist for patients with cystic fibrosis and pulmonary fibrosis.

PubMed

Liu, Yuan; Vela, Monica; Rudakevych, Tanya; Wigfield, Christopher; Garrity, Edward; Saunders, Milda R

2017-03-01

Since 2005, the Lung Allocation Score (LAS) has prioritized patient benefit and post-transplant survival, reducing waitlist to transplant time to <200 days and decreasing mortality on the waitlist. A current challenge is the wait for the waitlist-the time between the patient's transplant-eligible diagnosis and waitlist registration. We investigated whether sociodemographic (age, sex, race, insurance, marital status, median household income) and clinical (forced expiratory volume in 1 second [FEV 1 ] percent of predicted, body mass index, depression/anxiety, alcohol/substance misuse, absolute/relative contraindications) factors influenced referral and waitlist registration. We conducted a retrospective cohort study through chart review of hospitalized patients on the University of Chicago general medicine service from 2006 to 2014 who met transplant-eligible criteria and ICD-9 billing codes for cystic fibrosis (CF) and pulmonary fibrosis (PF). We analyzed the times from transplant eligibility to referral, work-up and waitlisting using Kaplan-Meier curves and log-rank tests. Overall, the referral rate for transplant-eligible patients was 64%. Of those referred, approximately 36% reach the lung transplant waitlist. Referred CF patients were significantly more likely to reach the transplant waitlist than PF patients (CF 60% vs PF 22%, p < 0.05). In addition, CF patients had a shorter wait from transplant eligibility to waitlist than PF patients (329 vs 2,369 days, respectively [25th percentile], p < 0.05). Patients with PF and CF both faced delays from eligibility to referral and waitlist. Quality improvement efforts are needed to better identify and refer appropriate patients for lung transplant evaluation. Targeted interventions may facilitate more efficient evaluation completion and waitlist appearance. Copyright © 2017 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Treatment of transfusional iron overload in patients with myelodysplastic syndrome or severe anemia: data from multicenter clinical practices.

PubMed

Raptis, Anastasios; Duh, Mei Sheng; Wang, Si-Tien; Dial, Ellison; Fanourgiakis, Ilias; Fortner, Barry; Paley, Carole; Mody-Patel, Nikita; Corral, Mitra; Scott, Jeffrey

2010-01-01

Patients with myelodysplastic syndrome (MDS) or severe anemia requiring repeated red blood cell (RBC) transfusions risk developing transfusional iron overload, which can reduce survival. Iron chelation therapy (ICT) has been shown to improve survival and quality of life in patients; however, ICT utilization in clinical practices is not well understood. Medical records of patients diagnosed with MDS or severe anemia at least 6 months before data extraction, aged at least 21 years at diagnosis, and who received at least one RBC transfusion were reviewed. ICT eligibility was defined as at least 20 units of RBCs transfused or at least two serum ferritin levels exceeding 1000 microg/L. Study endpoint was ICT treatment rate among ICT-eligible patients with lower-risk MDS (International Prognostic Scoring System [low or intermediate-1]; World Health Organization [refractory anemia {RA}, refractory anemia with ringed sideroblasts {RARS}, refractory cytopenia with multilineage dysplasia {RCMD}, refractory cytopenia with multilineage dysplasia and ringed sideroblasts, or 5q]; French-American-British [RA/RARS]). Among 78 ICT-eligible patients with lower-risk MDS, 32 (41%) received ICT. At ICT initiation, treated patients received on average 13.3 transfusions (27.6 units) and mean first post-ICT initiation serum ferritin was twice the MDS Foundation recommendation at 1949 microg/L. Median overall survival for all ICT-eligible patients was significantly longer for those ICT-treated patients than untreated patients (8.7 years vs. 4.7 years, log-rank p = 0.02; multivariate hazard ratio 0.372, p = 0.03). This study finds only 41% of ICT-eligible patients with lower-risk MDS received ICT in clinical practice, and treatment was initiated later than recommended. Receipt of ICT was associated with significantly longer survival.

Extended International Normalized Ratio testing intervals for warfarin-treated patients.

PubMed

Barnes, G D; Kong, X; Cole, D; Haymart, B; Kline-Rogers, E; Almany, S; Dahu, M; Ekola, M; Kaatz, S; Kozlowski, J; Froehlich, J B

2018-05-15

Essentials Warfarin typically requires International Normalized Ratio (INR) testing at least every 4 weeks. We implemented extended INR testing for stable warfarin patients in six anticoagulation clinics. Use of extended INR testing increased from 41.8% to 69.3% over the 3 year study. Use of extended INR testing appeared safe and effective. Background A previous single-center randomized trial suggested that patients with stable International Normalized Ratio (INR) values could safely receive INR testing as infrequently as every 12 weeks. Objective To test the success of implementation of an extended INR testing interval for stable warfarin patients in a practice-based, multicenter collaborative of anticoagulation clinics. Methods At six anticoagulation clinics, patients were identified as being eligible for extended INR testing on the basis of prior INR value stability and minimal warfarin dose changes between 2014 and 2016. We assessed the frequency with which anticoagulation clinic providers recommended an extended INR testing interval (> 5 weeks) to eligible patients. We also explored safety outcomes for eligible patients, including next INR values, bleeding events, and emergency department visits. Results At least one eligible period for extended INR testing was identified in 890 of 3362 (26.5%) warfarin-treated patients. Overall, the use of extended INR testing in eligible patients increased from 41.8% in the first quarter of 2014 to 69.3% in the fourth quarter of 2016. The number of subsequent out-of-range next INR values were similar between eligible patients who did and did not have an extended INR testing interval (27.3% versus 28.4%, respectively). The numbers of major bleeding events were not different between the two groups, but rates of clinically relevant non-major bleeding (0.02 per 100 patient-years versus 0.09 per 100 patient-years) and emergency department visits (0.07 per 100 patient-years versus 0.19 per 100 patient-years) were lower for eligible patients with extended INR testing intervals than for those with non-extended INR testing intervals. Conclusions Extended INR testing for stable warfarin patients can be successfully and safely implemented in diverse, practice-based anticoagulation clinic settings. © 2018 International Society on Thrombosis and Haemostasis.

Impact of Clinical Genetics Attendance at a Gynecologic Oncology Tumor Board on Referrals for Genetic Counseling and BRCA Mutation Testing.

PubMed

Cohen, Paul A; Nichols, Cassandra B; Schofield, Lyn; Van Der Werf, Steven; Pachter, Nicholas

2016-06-01

The objectives of this work were to determine the proportion of eligible patients with ovarian cancer discussed at a gynecologic oncology tumor board who were referred for counseling and BRCA mutation testing; to compare referral rates before genetics attendance at the tumor board to referral rates after genetics attendance; and to ascertain the proportions of women with germline BRCA mutations. Eligible cases were identified from the minutes of the weekly Western Australian gynecologic oncology tumor board from July 1, 2013 to June 30, 2015.Patients with ovarian cancer who met eligibility criteria for genetics referral were identified and checked against the records of the genetic services database to ascertain whether a referral was received. Outcomes including attendance for counseling and results of mutation testing were analyzed. Two hundred sixty-one patients were eligible for referral during the 24-month study period. One hundred six patients (40.6%) were referred for counseling and germline mutation testing. Of the eligible patients, 26.7% were referred in the 12 months before genetics attendance at the tumor board compared to 51.7% of the eligible patients in the 12 months after genetics attendance (P ≤ 0.0001). Ninety-seven patients were offered BRCA mutation testing, and 73 underwent testing with 65 results reported to date. Twenty-two patients (33.8 %) tested positive for a germline BRCA mutation. Patients with ovarian cancer had a high rate of BRCA mutations. Attendance of a genetics service at a tumor board was associated with an improved rate of referral of patients for genetic counseling and BRCA mutation testing.

The efficacy and resource utilization of remifentanil and fentanyl in fast-track coronary artery bypass graft surgery: a prospective randomized, double-blinded controlled, multi-center trial.

PubMed

Cheng, D C; Newman, M F; Duke, P; Wong, D T; Finegan, B; Howie, M; Fitch, J; Bowdle, T A; Hogue, C; Hillel, Z; Pierce, E; Bukenya, D

2001-05-01

We compared (a) the perioperative complications; (b) times to eligibility for, and actual time of the following: extubation, less intense monitoring, intensive care unit (ICU), and hospital discharge; and (c) resource utilization of nursing ratio for patients receiving either a typical fentanyl/isoflurane/propofol regimen or a remifentanil/isoflurane/propofol regimen for fast-track cardiac anesthesia in 304 adults by using a prospective randomized, double-blinded, double-dummy trial. There were no differences in demographic data, or perioperative mortality and morbidity between the two study groups. The mini-mental status examination at postoperative Days 1 to 3 were similar between the two groups. The eligible and actual times for extubation, less intense monitoring, ICU discharge, and hospital discharge were not significantly different. Further analyses revealed no differences in times for extubation and resource utilization after stratification by preoperative risk scores, age, and country. The nurse/patient ratio was similar between the remifentanil/isoflurane/propofol and fentanyl/isoflu-rane/propofol groups during the initial ICU phase and less intense monitoring phase. Increasing preoperative risk scores and older age (>70 yr) were associated with longer times until extubation (eligible), ICU discharge (eligible and actual), and hospital discharge (eligible and actual). Times until extubation (eligible and actual) and less intense monitoring (eligible) were significantly shorter in Canadian patients than United States' patients. However, there was no difference in hospital length of stay in Canadian and United States' patients. We conclude that both anesthesia techniques permit early and similar times until tracheal extubation, less intense monitoring, ICU and hospital discharge, and reduced resource utilization after coronary artery bypass graft surgery. An ultra-short opioid technique was compared with a standard fast-track small-dose opioid technique in coronary artery bypass graft patients in a prospective randomized, double-blinded controlled study. The postoperative recovery and resource utilization, including stratification of preoperative risk score, age, and country, were analyzed.

Evaluation of Eligibility Criteria Used to Identify Patients for Medication Therapy Management Services: A Retrospective Cohort Study in a Medicare Advantage Part D Population.

PubMed

Lee, Janet S; Yang, Jianing; Stockl, Karen M; Lew, Heidi; Solow, Brian K

2016-01-01

General eligibility criteria used by the Centers for Medicare & Medicaid Services (CMS) to identify patients for medication therapy management (MTM) services include having multiple chronic conditions, taking multiple Part D drugs, and being likely to incur annual drug costs that exceed a predetermined threshold. The performance of these criteria in identifying patients in greatest need of MTM services is unknown. Although there are numerous possible versions of MTM identification algorithms that satisfy these criteria, there are limited data that evaluate the performance of MTM services using eligibility thresholds representative of those used by the majority of Part D sponsors. To (a) evaluate the performance of the 2013 CMS MTM eligibility criteria thresholds in identifying Medicare Advantage Prescription Drug (MAPD) plan patients with at least 2 drug therapy problems (DTPs) relative to alternative criteria threshold levels and (b) identify additional patient risk factors significantly associated with the number of DTPs for consideration as potential future MTM eligibility criteria. All patients in the Medicare Advantage Part D population who had pharmacy eligibility as of December 31, 2013, were included in this retrospective cohort study. Study outcomes included 7 different types of DTPs: use of high-risk medications in the elderly, gaps in medication therapy, medication nonadherence, drug-drug interactions, duplicate therapy, drug-disease interactions, and brand-to-generic conversion opportunities. DTPs were identified for each member based on 6 months of most recent pharmacy claims data and 14 months of most recent medical claims data. Risk factors examined in this study included patient demographics and prior health care utilization in the most recent 6 months. Descriptive statistics were used to summarize patient characteristics and to evaluate unadjusted relationships between the average number of DTPs identified per patient and each risk factor. Quartile values identified in the study population for number of diseases, number of drugs, and annual spend were used as potential new criteria thresholds, resulting in 27 new MTM criteria combinations. The performance of each eligibility criterion was evaluated using sensitivity, specificity, positive predictive values (PPVs), and negative predictive values (NPVs). Patients identified with at least 2 DTPs were defined as those who would benefit from MTM services and were used as the gold standard. As part of a sensitivity analysis, patients identified with at least 1 DTP were used as the gold standard. Lastly, a multivariable negative binomial regression model was used to evaluate the relationship between each risk factor and the number of identified DTPs per patient while controlling for the patients' number of drugs, number of chronic diseases, and annual drug spend. A total of 2,578,336 patients were included in the study. The sensitivity, specificity, PPV, and NPV of CMS MTM criteria for the 2013 plan year were 15.3%, 95.6%, 51.3%, and 78.8%, respectively. Sensitivity and PPV improved when the drug count threshold increased from 8 to 10, and when the annual drug cost decreased from $3,144 to $2,239 or less. Results were consistent when at least 1 DTP was used as the gold standard. The adjusted rate of DTPs was significantly greater among patients identified with higher drug and disease counts, annual drug spend, and prior ER or outpatient or hospital visits. Patients with higher median household incomes who were male, younger, or white had significantly lower rates of DTPs. The performance of MTM eligibility criteria can be improved by increasing the threshold values for drug count while decreasing the threshold value for annual drug spend. Furthermore, additional risk factors, such as a recent ER or hospital visit, may be considered as potential MTM eligibility criteria.

Eligibility and Predictors for Acute Revascularization Procedures in a Stroke Center.

PubMed

Vanacker, Peter; Lambrou, Dimitris; Eskandari, Ashraf; Mosimann, Pascal J; Maghraoui, Ali; Michel, Patrik

2016-07-01

Endovascular treatment (EVT) is a new standard of care for selected, large vessel occlusive strokes. We aimed to determine frequency of potentially eligible patients for intravenous thrombolysis (IVT) and EVT in comprehensive stroke centers. In addition, predictors of EVT eligibility were derived. Patients from a stroke center-based registry (2003-2014), admitted within 24 hours of last proof of usual health, were selected if they had all data to determine IVT and EVT eligibility according to American Heart Association/American Stroke Association (AHA/ASA) guidelines (class I-IIa recommendations). Moreover, less restrictive criteria adapted from randomized controlled trials and clinical practice were tested. Maximum onset-to-door time windows for IVT eligibility were 3.5 hours (allowing door-to-needle delay of ≤60 minutes) and 4.5 hours for EVT eligibility (door-to-groin delay ≤90 minutes). Demographic and clinical information were used in logistic regression analysis to derive variables associated with EVT eligibility. A total of 2704 patients with acute ischemic stroke were included, of which 26.8% were transfers. Of all patients with stroke arriving at our comprehensive stroke center, a total proportion of 12.4% patients was eligible for IVT. Frequency of EVT eligibility differed between AHA/ASA guidelines and less restrictive approach: 2.9% versus 4.9%, respectively, of all patients with acute ischemic stroke and 10.5% versus 17.7%, respectively, of all patients arriving within <6 hours. Predictors for AHA-EVT eligibility were younger, shorter onset-to-admission delays, higher National Institutes of Health Stroke Scale (NIHSS), decreased vigilance, hemineglect, absent cerebellar signs, atrial fibrillation, smoking, and decreasing glucose levels (area under the curve=0.86). Of patients arriving within 6 hours at a comprehensive stroke center, 10.5% are EVT eligible according to AHA/ASA criteria, 17.7% according to criteria resembling randomized controlled trials, and twice as many patients are IVT eligible (36.2%). © 2016 American Heart Association, Inc.

OWL model of clinical trial eligibility criteria compatible with partially-known information

PubMed Central

2013-01-01

Background Clinical trials are important for patients, for researchers and for companies. One of the major bottlenecks is patient recruitment. This task requires the matching of a large volume of information about the patient with numerous eligibility criteria, in a logically-complex combination. Moreover, some of the patient’s information necessary to determine the status of the eligibility criteria may not be available at the time of pre-screening. Results We showed that the classic approach based on negation as failure over-estimates rejection when confronted with partially-known information about the eligibility criteria because it ignores the distinction between a trial for which patient eligibility should be rejected and trials for which patient eligibility cannot be asserted. We have also shown that 58.64% of the values were unknown in the 286 prostate cancer cases examined during the weekly urology multidisciplinary meetings at Rennes’ university hospital between October 2008 and March 2009. We propose an OWL design pattern for modeling eligibility criteria based on the open world assumption to address the missing information problem. We validate our model on a fictitious clinical trial and evaluate it on two real clinical trials. Our approach successfully distinguished clinical trials for which the patient is eligible, clinical trials for which we know that the patient is not eligible and clinical trials for which the patient may be eligible provided that further pieces of information (which we can identify) can be obtained. Conclusions OWL-based reasoning based on the open world assumption provides an adequate framework for distinguishing those patients who can confidently be rejected from those whose status cannot be determined. The expected benefits are a reduction of the workload of the physicians and a higher efficiency by allowing them to focus on the patients whose eligibility actually require expertise. PMID:24034867

Increasing minority patient participation in cancer clinical trials using oncology nurse navigation.

PubMed

Holmes, Dennis Ricky; Major, Jacquelyn; Lyonga, Doris Efosi; Alleyne, Rebecca Simone; Clayton, Sheilah Marie

2012-04-01

Residential distance from an academic or cancer center is a significant barrier to minority patient participation in cancer research. Most cancer clinical trials (CTs) are only accessible at academic and cancer centers, yet most cancer patients receive treatment in their home communities where access to CTs may be limited. Oncology nurse navigation is an innovative approach for increasing minority CT participation by facilitating access to cancer CTs in communities where minority patients live. The purpose of this study was to evaluate the impact of oncology nurse navigation on community-based recruitment of black patients to breast cancer CTs at a major cancer center. We merged the roles of a traditional oncology research nurse and a professional patient navigator to create a novel health care provider role, the oncology nurse navigator. The primary duties of the oncology nurse navigator were to engage black cancer patients in the offices of their community physicians and to collaborate with community physicians to increase black patient participation in cancer research. The oncology nurse navigator played a key role in all phases of the CT participation process (e.g., screening for eligibility and completion of informed consent and clinical research forms) and guided each patient around barriers in the health care system. The accrual of eligible patients to breast cancer CTs was used to assess the impact of oncology nurse navigation on community-based recruitment of blacks to cancer CTs. Between January 2007 and December 2008, a total of 132 black breast cancer patients were screened by a single oncology nurse navigator for eligibility to University of Southern California-sponsored breast cancer CTs. Fifty-nine patients were eligible for CTs, and each was invited to participate in 1 or more CTs for which they were eligible. Fifty-one of 59 eligible black patients (86% of eligible patients) were enrolled to 1 or more research protocols. The estimated cost per enrolled patient was $5,677, nearly half the expected per patient cost of treating patients on CT at an academic or cancer center. Oncology nurse navigation is an effective outreach strategy for increasing black patient participation in cancer research and may be achieved at nearly half the cost of traditional methods of enrolling patients in CTs at cancer centers. Copyright © 2012 Elsevier Inc. All rights reserved.

Using Arden Syntax to Identify Registry-Eligible Very Low Birth Weight Neonates from the Electronic Health Record

PubMed Central

Sarkar, Indra Neil; Chen, Elizabeth S.; Rosenau, Paul T.; Storer, Matthew B.; Anderson, Beth; Horbar, Jeffrey D.

2014-01-01

Condition-specific registries are essential resources for supporting epidemiological, quality improvement, and clinical trial studies. The identification of potentially eligible patients for a given registry often involves a manual process or use of ad hoc software tools. With the increased availability of electronic health data, such as within Electronic Health Record (EHR) systems, there is potential to develop healthcare standards based approaches for interacting with these data. Arden Syntax, which has traditionally been used to represent medical knowledge for clinical decision support, is one such standard that may be adapted for the purpose of registry eligibility determination. In this feasibility study, Arden Syntax was explored for its ability to represent eligibility criteria for a registry of very low birth weight neonates. The promising performance (100% recall; 97% precision) of the Arden Syntax approach at a single institution suggests that a standards-based methodology could be used to robustly identify registry-eligible patients from EHRs. PMID:25954412

Lessons learned during implementation of therapeutic hypothermia for neonatal hypoxic ischemic encephalopathy in a regional transport program in Ontario

PubMed Central

Khurshid, Faiza; Lee, Kyong-Soon; McNamara, Patrick J; Whyte, Hilary; Mak, Wendy

2011-01-01

BACKGROUND: Therapeutic hypothermia (TH) is the first intervention to consistently show improved neurological outcomes in neonates with hypoxic ischemic encephalopathy (HIE). Since the recent introduction of TH for HIE in many centres, reviews of practices during the implementation of TH in Canada have not been published. OBJECTIVE: To determine if eligible neonates are being offered TH and to identify any barriers to the effective implementation of TH. METHODS: A retrospective review of neonates referred to a regional tertiary centre at a gestational age of 35 weeks or more with HIE was conducted. RESULTS: Among 41 neonates referred, 29 (71%) were eligible for TH; among eligible patients, five were moribund and excluded, and TH was initiated in 16 (67%) of the remaining 24. Reasons for not cooling in eight eligible patients included a delay in referral (n=5, median age at referral was 14 h) and a failure to recognize the severity of HIE (n=3). Among cooled patients, median times were the following: 116 min for age at referral; 80 min for time from referral to transport team arrival; and 358 min for age at initiation of cooling. Seven (44%) patients had cooling initiated after 6 h of age. CONCLUSION: A significant proportion of eligible patients were not offered TH, and in many cooled patients, initiation of cooling was delayed beyond the recommended 6 h. For eligible patients to benefit from TH, it is imperative that all birthing centres be made aware that TH is now widely available as an important treatment option, but also that TH is a time-sensitive therapy requiring rapid identification and referral. In the region studied, for eligible patients, referring hospitals should initiate passive cooling before arrival of the transport team. Referring hospitals should be prepared to provide early, yet safe initiation of passive cooling by having the appropriate equipment, and having staff trained in the use and monitoring of rectal temperatures. PMID:22379379

Implementation and Operational Research: Strengthening HIV Test Access and Treatment Uptake Study (Project STATUS): A Randomized Trial of HIV Testing and Counseling Interventions.

PubMed

McNaghten, A D; Schilsky Mneimneh, Allison; Farirai, Thato; Wamai, Nafuna; Ntiro, Marylad; Sabatier, Jennifer; Makhunga-Ramfolo, Nondumiso; Mwanasalli, Salli; Awor, Anna; Moore, Jan

2015-12-01

To determine which of 3 HIV testing and counseling (HTC) models in outpatient departments (OPDs) increases HIV testing and entry of newly identified HIV-infected patients into care. Randomized trial of HTC interventions. Thirty-six OPDs in South Africa, Tanzania, and Uganda were randomly assigned to 3 different HTC models: (A) health care providers referred eligible patients (aged 18-49, not tested in the past year, not known HIV positive) to on-site voluntary counseling and testing for HTC offered and provided by voluntary counseling and testing counselors after clinical consultation; (B) health care providers offered and provided HTC to eligible patients during clinical consultation; and (C) nurse or lay counselors offered and provided HTC to eligible patients before clinical consultation. Data were collected from October 2011 to September 2012. We describe testing eligibility and acceptance, HIV prevalence, and referral and entry into care. Chi-square analyses were conducted to examine differences by model. Of 79,910 patients, 45% were age eligible and 16,099 (45%) age eligibles were tested. Ten percent tested HIV positive. Significant differences were found in percent tested by model. The proportion of age eligible patients tested by Project STATUS was highest for model C (54.1%, 95% confidence interval [CI]: 42.4 to 65.9), followed by model A (41.7%, 95% CI: 30.7 to 52.8), and then model B (33.9%, 95% CI: 25.7 to 42.1). Of the 1596 newly identified HIV positive patients, 94% were referred to care (96.1% in model A, 94.7% in model B, and 94.9% in model C), and 58% entered on-site care (74.4% in model A, 54.8% in model B, and 55.6% in model C) with no significant differences in referrals or care entry by model. Model C resulted in the highest proportion of all age-eligible patients receiving a test. Although 94% of STATUS patients with a positive test result were referred to care, only 58% entered care. We found no differences in patients entering care by HTC model. Routine HTC in OPDs is acceptable to patients and effective for identifying HIV-infected persons, but additional efforts are needed to increase entry to care.

Generalizability of clinical trials of advanced melanoma in the real-world, population-based setting.

PubMed

Sam, Davis; Gresham, Gillian; Abdel-Rahman, Omar; Cheung, Winson Y

2018-06-18

Results from novel therapeutics trials are not always generalizable to real-world patients. We aimed to determine the pattern in which trial findings are applied in a population-based setting of melanoma patients and consequent treatment outcomes. Patients with unresectable disease during 2011-2014 and referred to cancer centers in a large Canadian province were retrospectively reviewed. Based on eligibility criteria as described in registration trials of vemurafenib (Vem) and ipilimumab (Ipi), we classified patients into trial-eligible and ineligible and those treated and untreated with these agents. We identified 290 patients with known BRAF status for the Vem analysis and 212 patients previously treated with first-line agents for the Ipi analysis. For the Vem cohort, a total of 49 patients were considered trial-eligible, of whom 36 (73%) received treatment. For the Ipi cohort, there were 119 trial-eligible cases of whom 43 (36%) received therapy. Factors other than eligibility criteria most frequently associated with non-treatment in these cohorts included concerns regarding treatment harm and patient preferences. In multivariable analysis, overall survival was improved in Vem cohort patients considered trial-eligible and treated compared to those who were ineligible. Within the Ipi cohort, survival was improved in trial-eligible patients regardless of whether they received Ipi compared to ineligible patients. Real-world uptake of new melanoma treatments was suboptimal, and non-use in trial-eligible patients was frequent. Future clinical trials that are more pragmatically designed to include participants who better reflect the real-world population may facilitate increased uptake of novel therapeutics into routine clinical practice.

Patient navigation to facilitate early intervention referral completion among poor urban children.

PubMed

Guevara, James P; Rothman, Brooke; Brooks, Elizabeth; Gerdes, Marsha; McMillon-Jones, Fayetta; Yun, Katherine

2016-09-01

Few eligible children participate in early intervention (EI) programs. The objective of this study was to determine feasibility and outcomes of a novel patient navigation program on EI referrals among a diverse group of at-risk children. During a 6-month period, a patient navigator was assigned to an urban pediatric clinic to engage families, provide education on early child development and EI, and assist families with completing multidisciplinary evaluations. Families were eligible to participate if they spoke English, had a child <34 months old with a suspected developmental delay, and were referred to EI for evaluation. Families completed measures of demographics, language preference, and the Newest Vital Sign, a validated literacy measure. Outcomes on completion of EI referrals were obtained from the county EI provider. Of 88 EI referrals during the study period, 53 patients were eligible and enrolled. Patients were predominantly male, racially diverse, on public health insurance, with a mean age of 18.4 months. Most caregivers of patients had less than a high school education, spoke a non-English language at home, and had limited literacy. Forty-two families (79.2%) completed a referral, and 34 (81.0%) of those were eligible for EI services. There were no significant differences in demographic, language, or literacy measures between those who completed and did not complete EI referrals. A patient navigation program to facilitate EI referrals was feasible in a diverse urban patient population. Preliminary results of the patient navigation program on EI referral completion were promising and warrant further study. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Eligibility for statin therapy by the JUPITER trial criteria and subsequent mortality.

PubMed

Cushman, Mary; McClure, Leslie A; Lakoski, Susan G; Jenny, Nancy S

2010-01-01

Justification for the Use of Statins in Primary Prevention: An Intervention Trial Using Rosuvastatin (JUPITER) reported reduced cardiovascular and all-cause mortality with statin treatment in patients with elevated C-reactive protein (CRP) and average cholesterol levels who were not eligible for lipid-lowering treatment on the basis of existing guidelines. The aim of this study was to determine the prevalence of eligibility and mortality in a general population sample on the basis of eligibility for statin treatment using the JUPITER criteria. The study group consisted of 30,229 participants in the REasons for Geographic and Racial Differences in Stroke (REGARDS) cohort, an observational study of US African American and white participants aged > or =45 years, enrolled in their homes from 2003 to 2007 and followed biannually by telephone. Among 11,339 participants age eligible for JUPITER and without vascular diagnoses or using lipid-lowering treatment, 21% (n = 2,342) met JUPITER entry criteria. Compared with JUPITER participants, they had similar low-density lipoprotein cholesterol and CRP levels, were more often women, were more often black, had metabolic syndrome, and used aspirin for cardioprotection. Over 3.5 years of follow-up, the mortality rate in REGARDS participants eligible for JUPITER was 1.17 per 100 patient-years (95% confidence interval 0.94 to 1.42). Compared with those otherwise JUPITER eligible who had CRP levels <2 mg/L (n = 2,620), those with CRP levels > or =2 mg/L had a multivariate-adjusted relative risk of 1.5 (95% confidence interval 1.1 to 2.2) for total mortality. In conclusion, 21% not otherwise eligible would be newly eligible for lipid lowering treatment on the basis of JUPITER trial eligibility.

The epidemiology of chronic critical illness in the United States*.

PubMed

Kahn, Jeremy M; Le, Tri; Angus, Derek C; Cox, Christopher E; Hough, Catherine L; White, Douglas B; Yende, Sachin; Carson, Shannon S

2015-02-01

The epidemiology of chronic critical illness is not well characterized. We sought to determine the prevalence, outcomes, and associated costs of chronic critical illness in the United States. Population-based cohort study using data from the United States Healthcare Costs and Utilization Project from 2004 to 2009. Acute care hospitals in Massachusetts, North Carolina, Nebraska, New York, and Washington. Adult and pediatric patients meeting a consensus-derived definition for chronic critical illness, which included one of six eligible clinical conditions (prolonged acute mechanical ventilation, tracheotomy, stroke, traumatic brain injury, sepsis, or severe wounds) plus at least 8 days in an ICU. None. Out of 3,235,741 admissions to an ICU during the study period, 246,151 (7.6%) met the consensus definition for chronic critical illness. The most common eligibility conditions were prolonged acute mechanical ventilation (72.0% of eligible admissions) and sepsis (63.7% of eligible admissions). Among patients meeting chronic critical illness criteria through sepsis, the infections were community acquired in 48.5% and hospital acquired in 51.5%. In-hospital mortality was 30.9% with little change over the study period. The overall population-based prevalence was 34.4 per 100,000. The prevalence varied substantially with age, peaking at 82.1 per 100,000 individuals 75-79 years old but then declining coincident with a rise in mortality before day 8 in otherwise eligible patients. Extrapolating to the entire United States, for 2009, we estimated a total of 380,001 cases; 107,880 in-hospital deaths and $26 billion in hospital-related costs. Using a consensus-based definition, the prevalence, hospital mortality, and costs of chronic critical illness are substantial. Chronic critical illness is particularly common in the elderly although in very old patients the prevalence declines, in part because of an increase in early mortality among potentially eligible patients.

Introduction and evaluation of a ‘pre-ART care’ service in Swaziland: an operational research study

PubMed Central

Burtle, David; Elden, Susan; Mamvura, Canaan; Vandelanotte, Joris; Petherick, Emily; Walley, John; Wright, John

2012-01-01

Objective To implement and evaluate a formal pre-antiretroviral therapy (ART) care service at a district hospital in Swaziland. Design Operational research. Setting District hospital in Southern Africa. Participants 1171 patients with a previous diagnosis of HIV. A baseline patient group consisted of the first 200 patients using the service. Two follow-up groups were defined: group 1 was all patients recruited from April to June 2009 and group 2 was 200 patients recruited in February 2010. Intervention Introduction of pre-ART care—a package of interventions, including counselling; regular review; clinical staging; timely initiation of ART; social and psychological support; and prevention and management of opportunistic infections, such as tuberculosis. Primary and secondary outcome measures Proportion of patients assessed for ART eligibility, proportion of eligible patients who were started on ART and proportion receiving defined evidence-based interventions (including prophylactic co-trimoxazole and tuberculosis screening). Results Following the implementation of the pre-ART service, the proportion of patients receiving defined interventions increased; the proportion of patient being assessed for ART eligibility significantly increased (baseline: 59%, group 1: 64%, group 2: 76%; p=0.001); the proportion of ART-eligible patients starting treatment increased (baseline: 53%, group 1: 81%, group: 2, 81%; p<0.001) and the median time between patients being declared eligible for ART and initiation of treatment significantly decreased (baseline: 61 days, group 1: 39 days, group 2: 14 days; p<0.001). Conclusions This intervention was part of a shift in the model of care from a fragmented acute care model to a more comprehensive service. The introduction of structured pre-ART was associated with significant improvements in the assessment, management and timeliness of initiation of treatment for patients with HIV. PMID:22422913

Treatment eligibility and retention in clinical HIV care: A regression discontinuity study in South Africa

PubMed Central

Bor, Jacob; Tanser, Frank; Bärnighausen, Till

2017-01-01

Background Loss to follow-up is high among HIV patients not yet receiving antiretroviral therapy (ART). Clinical trials have demonstrated the clinical efficacy of early ART; however, these trials may miss an important real-world consequence of providing ART at diagnosis: its impact on retention in care. Methods and findings We examined the effect of immediate (versus deferred) ART on retention in care using a regression discontinuity design. The analysis included all patients (N = 11,306) entering clinical HIV care with a first CD4 count between 12 August 2011 and 31 December 2012 in a public-sector HIV care and treatment program in rural South Africa. Patients were assigned to immediate versus deferred ART eligibility, as determined by a CD4 count < 350 cells/μl, per South African national guidelines. Patients referred to pre-ART care were instructed to return every 6 months for CD4 monitoring. Patients initiated on ART were instructed to return at 6 and 12 months post-initiation and annually thereafter for CD4 and viral load monitoring. We assessed retention in HIV care at 12 months, as measured by the presence of a clinic visit, lab test, or ART initiation 6 to 18 months after initial CD4 test. Differences in retention between patients presenting with CD4 counts just above versus just below the 350-cells/μl threshold were estimated using local linear regression models with a data-driven bandwidth and with the algorithm for selecting the bandwidth chosen ex ante. Among patients with CD4 counts close to the 350-cells/μl threshold, having an ART-eligible CD4 count (<350 cells/μl) was associated with higher 12-month retention than not having an ART-eligible CD4 count (50% versus 32%), an intention-to-treat risk difference of 18 percentage points (95% CI 11 to 23; p < 0.001). The decision to start ART was determined by CD4 count for one in four patients (25%) presenting close to the eligibility threshold (95% CI 20% to 31%; p < 0.001). In this subpopulation, having an ART-eligible CD4 count was associated with higher 12-month retention than not having an ART-eligible CD4 count (91% versus 21%), a complier causal risk difference of 70 percentage points (95% CI 42 to 98; p < 0.001). The major limitations of the study are the potential for limited generalizability, the potential for outcome misclassification, and the absence of data on longer-term health outcomes. Conclusions Patients who were eligible for immediate ART had dramatically higher retention in HIV care than patients who just missed the CD4-count eligibility cutoff. The clinical and population health benefits of offering immediate ART regardless of CD4 count may be larger than suggested by clinical trials. PMID:29182641

Increasing recruitment rates in an inpatient clinical research study using quality improvement methods.

PubMed

Sauers, Hadley S; Beck, Andrew F; Kahn, Robert S; Simmons, Jeffrey M

2014-11-01

One important benefit of successful patient recruitment is increased generalizability of findings. We sought to optimize enrollment of children admitted with asthma as part of a population-based, prospective, observational cohort study with the goal of enrolling at least 60% of all eligible and staffed patients. Quality improvement methods were used to improve cohort recruitment. Weekly meetings with study staff and study leadership were held to plan and discuss how to maximize recruitment rates. Significant initial variability in recruitment success prompted the team to use small-scale tests of change to increase recruitment numbers. A number of tests were trialed, focusing primarily on reducing patient refusals and improving recruitment process efficiency. Recruitment rates were calculated by dividing eligible by enrolled patients and displayed using annotated Shewhart control charts. Control charts were used to illustrate week-to-week variability while also enabling differentiation of common-cause and special-cause variation. The study enrolled 774 patients, representing 54% of all eligible and 59% of those eligible for whom staff were available to enroll. Our mean weekly recruitment rate increased from 55% during the first 3 months of the study to a statistically significant sustained rate of 61%. This was sustained given numerous obstacles, such as departing and hiring of staff and adding a second recruitment location. Implementing quality improvement methods within a larger research study led to an increase in the rate of recruitment as well as the stability in recruitment rates from week-to-week. Copyright © 2014 by the American Academy of Pediatrics.

Patient outcomes after critical illness: a systematic review of qualitative studies following hospital discharge.

PubMed

Hashem, Mohamed D; Nallagangula, Aparna; Nalamalapu, Swaroopa; Nunna, Krishidhar; Nausran, Utkarsh; Robinson, Karen A; Dinglas, Victor D; Needham, Dale M; Eakin, Michelle N

2016-10-26

There is growing interest in patient outcomes following critical illness, with an increasing number and different types of studies conducted, and a need for synthesis of existing findings to help inform the field. For this purpose we conducted a systematic review of qualitative studies evaluating patient outcomes after hospital discharge for survivors of critical illness. We searched the PubMed, EMBASE, CINAHL, PsycINFO, and CENTRAL databases from inception to June 2015. Studies were eligible for inclusion if the study population was >50 % adults discharged from the ICU, with qualitative evaluation of patient outcomes. Studies were excluded if they focused on specific ICU patient populations or specialty ICUs. Citations were screened in duplicate, and two reviewers extracted data sequentially for each eligible article. Themes related to patient outcome domains were coded and categorized based on the main domains of the Patient Reported Outcomes Measurement Information System (PROMIS) framework. A total of 2735 citations were screened, and 22 full-text articles were eligible, with year of publication ranging from 1995 to 2015. All of the qualitative themes were extracted from eligible studies and then categorized using PROMIS descriptors: satisfaction with life (16 studies), including positive outlook, acceptance, gratitude, independence, boredom, loneliness, and wishing they had not lived; mental health (15 articles), including symptoms of post-traumatic stress disorder, anxiety, depression, and irritability/anger; physical health (14 articles), including mobility, activities of daily living, fatigue, appetite, sensory changes, muscle weakness, and sleep disturbances; social health (seven articles), including changes in friends/family relationships; and ability to participate in social roles and activities (six articles), including hobbies and disability. ICU survivors may experience positive emotions and life satisfaction; however, a wide range of mental, physical, social, and functional sequelae occur after hospital discharge. These findings are important for understanding patient-centered outcomes in critical care and providing focus for future interventional studies aimed at improving outcomes of importance to ICU survivors.

Pathological upgrading in prostate cancer patients eligible for active surveillance: Does prostate-specific antigen density matter?

PubMed

Jin, Byung-Soo; Kang, Seok-Hyun; Kim, Duk-Yoon; Oh, Hoon-Gyu; Kim, Chun-Il; Moon, Gi-Hak; Kwon, Tae-Gyun; Park, Jae-Shin

2015-09-01

To evaluate prospectively the role of prostate-specific antigen (PSA) density in predicting Gleason score upgrading in prostate cancer patients eligible for active surveillance (T1/T2, biopsy Gleason score≤6, PSA≤10 ng/mL, and ≤2 positive biopsy cores). Between January 2010 and November 2013, among patients who underwent greater than 10-core transrectal ultrasound-guided biopsy, 60 patients eligible for active surveillance underwent radical prostatectomy. By use of the modified Gleason criteria, the tumor grade of the surgical specimens was examined and compared with the biopsy results. Tumor upgrading occurred in 24 patients (40.0%). Extracapsular disease and positive surgical margins were found in 6 patients (10.0%) and 8 patients (17.30%), respectively. A statistically significant correlation between PSA density and postoperative upgrading was found (p=0.030); this was in contrast with the other studied parameters, which failed to reach significance, including PSA, prostate volume, number of biopsy cores, and number of positive cores. Tumor upgrading was also highly associated with extracapsular cancer extension (p=0.000). The estimated optimal cutoff value of PSA density was 0.13 ng/mL(2), obtained by receiver operating characteristic analysis (area under the curve=0.66; p=0.020; 95% confidence interval, 0.53-0.78). PSA density is a strong predictor of Gleason score upgrading after radical prostatectomy in patients eligible for active surveillance. Because tumor upgrading increases the potential for postoperative pathological adverse findings and prognosis, PSA density should be considered when treating and consulting patients eligible for active surveillance.

An Analysis of the Public Financial Support Eligibility Rule for French Dependent Elders with Alzheimer's Disease.

PubMed

Rapp, Thomas; Lacey, Loretto; Ousset, Pierre-Jean; Cowppli-Bony, Pascale; Vellas, Bruno; Orgogozo, Jean-Marc

2015-07-01

It is crucial to define health policies that target patients with the highest needs. In France, public financial support is provided to dependent patients: it can be used to finance informal care time and nonmedical care use. Eligibility for public subsidies and reimbursement of costs is associated with a specific tool: the autonomie gérontologie groupes iso-ressources (AGGIR) scale score. Our objective was to explore whether patients with Alzheimer's disease who are eligible for public financial support have greater needs than do noneligible patients. Using data from the Dépendance des patients atteints de la maladie d'Alzheimer en France study, we calculated nonmedical care expenditures (in €) using microcosting methods and informal care time demand (hours/month) using the Resource Use in Dementia questionnaire. We measured the burden associated with informal care provision with Zarit Burden Interview. We used a modified two-part model to explore the correlation between public financial support eligibility and these three variables. We find evidence of higher informal care use, higher informal caregivers' burden, and higher care expenditures when patients have an AGGIR scale score corresponding to public financial support eligibility. The AGGIR scale is useful to target patients with the highest costs and needs. Given our results, public subsidies could be used to further sustain informal caregivers networks by financing programs dedicated to lowering informal caregivers' burden. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Computational challenges and human factors influencing the design and use of clinical research participant eligibility pre-screening tools

PubMed Central

2012-01-01

Background Clinical trials are the primary mechanism for advancing clinical care and evidenced-based practice, yet challenges with the recruitment of participants for such trials are widely recognized as a major barrier to these types of studies. Data warehouses (DW) store large amounts of heterogenous clinical data that can be used to enhance recruitment practices, but multiple challenges exist when using a data warehouse for such activities, due to the manner of collection, management, integration, analysis, and dissemination of the data. A critical step in leveraging the DW for recruitment purposes is being able to match trial eligibility criteria to discrete and semi-structured data types in the data warehouse, though trial eligibility criteria tend to be written without concern for their computability. We present the multi-modal evaluation of a web-based tool that can be used for pre-screening patients for clinical trial eligibility and assess the ability of this tool to be practically used for clinical research pre-screening and recruitment. Methods The study used a validation study, usability testing, and a heuristic evaluation to evaluate and characterize the operational characteristics of the software as well as human factors affecting its use. Results Clinical trials from the Division of Cardiology and the Department of Family Medicine were used for this multi-modal evaluation, which included a validation study, usability study, and a heuristic evaluation. From the results of the validation study, the software demonstrated a positive predictive value (PPV) of 54.12% and 0.7%, respectively, and a negative predictive value (NPV) of 73.3% and 87.5%, respectively, for two types of clinical trials. Heuristic principles concerning error prevention and documentation were characterized as the major usability issues during the heuristic evaluation. Conclusions This software is intended to provide an initial list of eligible patients to a clinical study coordinators, which provides a starting point for further eligibility screening by the coordinator. Because this software has a high “rule in” ability, meaning that it is able to remove patients who are not eligible for the study, the use of an automated tool built to leverage an existing enterprise DW can be beneficial to determining eligibility and facilitating clinical trial recruitment through pre-screening. While the results of this study are promising, further refinement and study of this and related approaches to automated eligibility screening, including comparison to other approaches and stakeholder perceptions, are needed and future studies are planned to address these needs. PMID:22646313

Computational challenges and human factors influencing the design and use of clinical research participant eligibility pre-screening tools.

PubMed

Pressler, Taylor R; Yen, Po-Yin; Ding, Jing; Liu, Jianhua; Embi, Peter J; Payne, Philip R O

2012-05-30

Clinical trials are the primary mechanism for advancing clinical care and evidenced-based practice, yet challenges with the recruitment of participants for such trials are widely recognized as a major barrier to these types of studies. Data warehouses (DW) store large amounts of heterogenous clinical data that can be used to enhance recruitment practices, but multiple challenges exist when using a data warehouse for such activities, due to the manner of collection, management, integration, analysis, and dissemination of the data. A critical step in leveraging the DW for recruitment purposes is being able to match trial eligibility criteria to discrete and semi-structured data types in the data warehouse, though trial eligibility criteria tend to be written without concern for their computability. We present the multi-modal evaluation of a web-based tool that can be used for pre-screening patients for clinical trial eligibility and assess the ability of this tool to be practically used for clinical research pre-screening and recruitment. The study used a validation study, usability testing, and a heuristic evaluation to evaluate and characterize the operational characteristics of the software as well as human factors affecting its use. Clinical trials from the Division of Cardiology and the Department of Family Medicine were used for this multi-modal evaluation, which included a validation study, usability study, and a heuristic evaluation. From the results of the validation study, the software demonstrated a positive predictive value (PPV) of 54.12% and 0.7%, respectively, and a negative predictive value (NPV) of 73.3% and 87.5%, respectively, for two types of clinical trials. Heuristic principles concerning error prevention and documentation were characterized as the major usability issues during the heuristic evaluation. This software is intended to provide an initial list of eligible patients to a clinical study coordinators, which provides a starting point for further eligibility screening by the coordinator. Because this software has a high "rule in" ability, meaning that it is able to remove patients who are not eligible for the study, the use of an automated tool built to leverage an existing enterprise DW can be beneficial to determining eligibility and facilitating clinical trial recruitment through pre-screening. While the results of this study are promising, further refinement and study of this and related approaches to automated eligibility screening, including comparison to other approaches and stakeholder perceptions, are needed and future studies are planned to address these needs.

Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study.

PubMed

Maxwell, Amy E; MacLeod, Mary Joan; Joyson, Anu; Johnson, Sharon; Ramadan, Hawraman; Bellfield, Ruth; Byrne, Anthony; McGhee, Caroline; Rudd, Anthony; Price, Fiona; Vasileiadis, Evangelos; Holden, Melinda; Hewitt, Jonathan; Carpenter, Michael; Needle, Ann; Valentine, Stacey; Patel, Farzana; Harrington, Frances; Mudd, Paul; Emsley, Hedley; Gregary, Bindu; Kane, Ingrid; Muir, Keith; Tiwari, Divya; Owusu-Agyei, Peter; Temple, Natalie; Sekaran, Lakshmanan; Ragab, Suzanne; England, Timothy; Hedstrom, Amanda; Jones, Phil; Jones, Sarah; Doherty, Mandy; McCarron, Mark O; Cohen, David L; Tysoe, Sharon; Al-Shahi Salman, Rustam

2017-04-05

Recruitment to randomised prevention trials is challenging, not least for intracerebral haemorrhage (ICH) associated with antithrombotic drug use. We investigated reasons for not recruiting apparently eligible patients at hospital sites that keep screening logs in the ongoing REstart or STop Antithrombotics Randomised Trial (RESTART), which seeks to determine whether to start antiplatelet drugs after ICH. By the end of May 2015, 158 participants had been recruited at 108 active sites in RESTART. The trial coordinating centre invited all sites that kept screening logs to submit screening log data, followed by one reminder. We checked the integrity of data, focused on the completeness of data about potentially eligible patients and categorised the reasons they were not randomised. Of 108 active sites, 39 (36%) provided usable screening log data over a median of ten (interquartile range = 5-13) months of recruitment per site. During this time, sites screened 633 potentially eligible patients and randomised 53 (8%) of them. The main reasons why 580 patients were not randomised were: 43 (7%) patients started anticoagulation, 51 (9%) patients declined, 148 (26%) patients' stroke physicians were not uncertain about using antiplatelet drugs, 162 (28%) patients were too unwell and 176 (30%) patients were not randomised due to other reasons. RESTART recruited ~8% of eligible patients. If more physicians were uncertain about the therapeutic dilemma that RESTART is addressing, RESTART could have recruited up to four times as many participants. The trial coordinating centre continues to engage with physicians about their uncertainty. EU Clinical Trials, EudraCT 2012-003190-26 . Registered on 3 July 2012.

Patient selection for day case-eligible surgery: identifying those at high risk for major complications.

PubMed

Mathis, Michael R; Naughton, Norah N; Shanks, Amy M; Freundlich, Robert E; Pannucci, Christopher J; Chu, Yijia; Haus, Jason; Morris, Michelle; Kheterpal, Sachin

2013-12-01

Due to economic pressures and improvements in perioperative care, outpatient surgical procedures have become commonplace. However, risk factors for outpatient surgical morbidity and mortality remain unclear. There are no multicenter clinical data guiding patient selection for outpatient surgery. The authors hypothesize that specific risk factors increase the likelihood of day case-eligible surgical morbidity or mortality. The authors analyzed adults undergoing common day case-eligible surgical procedures by using the American College of Surgeons' National Surgical Quality Improvement Program database from 2005 to 2010. Common day case-eligible surgical procedures were identified as the most common outpatient surgical Current Procedural Terminology codes provided by Blue Cross Blue Shield of Michigan and Medicare publications. Study variables included anthropometric data and relevant medical comorbidities. The primary outcome was morbidity or mortality within 72 h. Intraoperative complications included adverse cardiovascular events; postoperative complications included surgical, anesthetic, and medical adverse events. Of 244,397 surgeries studied, 232 (0.1%) experienced early perioperative morbidity or mortality. Seven independent risk factors were identified while controlling for surgical complexity: overweight body mass index, obese body mass index, chronic obstructive pulmonary disease, history of transient ischemic attack/stroke, hypertension, previous cardiac surgical intervention, and prolonged operative time. The demonstrated low rate of perioperative morbidity and mortality confirms the safety of current day case-eligible surgeries. The authors obtained the first prospectively collected data identifying risk factors for morbidity and mortality with day case-eligible surgery. The results of the study provide new data to advance patient-selection processes for outpatient surgery.

Case-based reasoning using electronic health records efficiently identifies eligible patients for clinical trials

PubMed Central

Miotto, Riccardo

2015-01-01

Objective To develop a cost-effective, case-based reasoning framework for clinical research eligibility screening by only reusing the electronic health records (EHRs) of minimal enrolled participants to represent the target patient for each trial under consideration. Materials and Methods The EHR data—specifically diagnosis, medications, laboratory results, and clinical notes—of known clinical trial participants were aggregated to profile the “target patient” for a trial, which was used to discover new eligible patients for that trial. The EHR data of unseen patients were matched to this “target patient” to determine their relevance to the trial; the higher the relevance, the more likely the patient was eligible. Relevance scores were a weighted linear combination of cosine similarities computed over individual EHR data types. For evaluation, we identified 262 participants of 13 diversified clinical trials conducted at Columbia University as our gold standard. We ran a 2-fold cross validation with half of the participants used for training and the other half used for testing along with other 30 000 patients selected at random from our clinical database. We performed binary classification and ranking experiments. Results The overall area under the ROC curve for classification was 0.95, enabling the highlight of eligible patients with good precision. Ranking showed satisfactory results especially at the top of the recommended list, with each trial having at least one eligible patient in the top five positions. Conclusions This relevance-based method can potentially be used to identify eligible patients for clinical trials by processing patient EHR data alone without parsing free-text eligibility criteria, and shows promise of efficient “case-based reasoning” modeled only on minimal trial participants. PMID:25769682

The Role of Conventional and Right-Sided ECG Screening for Subcutaneous ICD in a Tetralogy of Fallot Population.

PubMed

Alonso, Pau; Osca, Joaquín; Cano, Oscar; Pimenta, Pedro; Andrés, Ana; Yagüe, Jaime; Millet, José; Rueda, Joaquín; Sancho-Tello, María José

2017-02-01

Information regarding suitability for subcutaneous implantable cardioverter-defibrillator (S-ICD) implant in tetralogy of Fallot (ToF) population is scarce and needs to be further explored. (1) to determine the proportion of patients with ToF eligible for S-ICD, (2) to identify the optimal sensing vector in ToF patients, (3) to test specifically the eligibility for S-ICD with right-sided screening, and (4) to compare with the proportion of eligible patients in a nonselected ICD population. We recruited 60 consecutive patients with ToF and 40 consecutive nonselected patients. Conventional electrocardiographic screening was performed as usual. Right-sided alternative screening was studied by positioning the left arm and right arm electrodes 1 cm right lateral to the xiphoid midline. The Boston Scientific electrocardiogram (ECG) screening tool was utilized. We found a higher proportion of patients with right-sided positive screening in comparison with standard screening (77 ± 0.4% vs. 67 ± 0.4%; P < 0.0001) and a trend to higher number of appropriate leads in right-sided screening (1.3 ± 1 vs. 1.1 ± 1 ms; P = 0.07). Patients who failed the screening had a longer QRS duration and longer QT interval. Standard and right-sided screening showed a higher percent of positive patients in the control group compared to ToF patients (P < 0.001). Right-sided screening was associated with a significant 10% increase in S-ICD eligibility in ToF patients. When comparing with an acquired cardiomyopathies group, ToF showed a lower eligibility for S-ICD. The most appropriate ECG vector was the alternate vector in contrast to what is observed in the general population. © 2017 Wiley Periodicals, Inc.

Characteristics and Medication Use of Psoriasis Patients Who May or May Not Qualify for Randomized Controlled Trials.

PubMed

Malatestinic, William; Nordstrom, Beth; Wu, Jashin J; Goldblum, Orin; Solotkin, Kathleen; Lin, Chen-Yen; Kistler, Kristin; Fraeman, Kathy; Johnston, Joseph; Hawley, Lcdr Lesley; Sicignano, Nicholas; Araujo, Andre

2017-03-01

Clinical trials impose exclusion criteria that may limit the generalizability of results. To (a) determine the percentage of real-world patients who would qualify for psoriasis randomized controlled trials; (b) ascertain differences between moderate-to-severe psoriasis patients who would be eligible, ineligible, or potentially eligible for clinical trials; and (c) compare their biologic treatment patterns. Moderate-to-severe psoriasis patients were identified from the U.S. Department of Defense health care database from January 1, 2008, to October 31, 2013. Eligibility classification for psoriasis trials was based on common trial exclusion criteria involving medical conditions and recent treatment history. Patient characteristics and treatment patterns of 4 biologics (adalimumab, etanercept, infliximab, and ustekinumab) were compared between groups. Adherence was measured by medication possession ratio and persistence as continuous time on drug with ≤ 90-day gap between supply times. Among 16,284 qualifying psoriasis patients, 4,677 (28.7%) were medically ineligible, and 8,466 (52.0%) had ineligibility-related treatments that could be stopped prior to trial entry; the latter patients were considered potentially eligible for psoriasis trials. Common reasons for medical ineligibility included malignancies and hematologic disorders; treatment ineligibilities included use of topical corticosteroids and phototherapy. Medically ineligible patients were older and had more comorbidities, while potentially eligible patients were younger and healthier than trial-eligible patients. Most treatment patterns were similar across groups, except that, compared with the trial-eligible group, medically ineligible patients had greater adherence to infliximab and potentially trial-eligible patients had greater adherence and persistence to adalimumab. This large real-world study found that patients who may be ineligible for psoriasis trials differ in important respects (e.g., comorbidities, prior treatments) from their trial-eligible counterparts. Regardless of their differences at baseline, adherence, persistence, and switching of biologic medications are largely similar, with few differences noted among groups. Financial support for this study was provided by Lilly USA. Wu has received research funding from AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Coherus Biosciences, Dermira, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Regeneron, Sandoz, and Sun Pharmaceutical Industries, and he is a consultant for AbbVie, Amgen, Celgene, Dermira, Eli Lilly, Pfizer, Regeneron, and Sun Pharmaceutical Industries. Malatestinic, Goldblum, Solotkin, Lin, Johnston, and Araujo are employees and/or stock owners of Lilly. Nordstrom, Kistler, and Fraeman are employees of Evidera, which received funding from Lilly to conduct this study. LCDR Hawley is a military service member. This work was prepared as part of her official duties. Title 17 U.S.C. 105 provides that "copyright protection under this title is not available for any work of the United States Government." Title 17 U.S.C. 101 defines a U.S. government work as a work prepared by a military service member or employee of the U.S. government as part of that person's official duties. Research data were derived from an approved Naval Medical Center, Portsmouth, Virginia, institutional review board protocol. The views expressed in this work are those of the authors and do not necessarily reflect the official policy or position of the Department of the Navy, Department of Defense, or the U.S. government. Study concept and design were contributed by Malatestinic and Araujo, along with the other authors. Nordstrom, Kistler, Fraeman, and Sicignano collected the data, and data interpretation was performed by Wu, Lin, and Hawley, along with Malatestinic, Nordstrom, Solotkin, and Araujo. The manuscript was written by Johnston, Malatestinic, Kistler, Wu, and Araujo, along with Nordstrom, Goldblum, Solotkin, Hawley, and Sicignano, and revised by Goldblum, Solotkin, Malatestinic, and Araujo, along with Nordstrom, Wu, Fraeman, Johnston, Hawley, and Sicignano.

Comparison of American Academy of Sleep Medicine (AASM) versus Center for Medicare and Medicaid Services (CMS) polysomnography (PSG) scoring rules on AHI and eligibility for continuous positive airway pressure (CPAP) treatment.

PubMed

Korotinsky, Arkady; Assefa, Samson Z; Diaz-Abad, Montserrat; Wickwire, Emerson M; Scharf, Steven M

2016-12-01

Obstructive sleep apnea (OSA) is an important clinical condition. Eligibility for treatment usually depends on disease severity, measured as the apnea-hypopnea index (AHI), equal to the sum of apneas plus hypopneas per hour of sleep. There is divergence on scoring rules for hypopneas between the recommendations of the American Academy of Sleep Medicine (AASM) and the Center for Medicare Services (CMS), the latter being more restrictive. Thus, patients could be eligible for treatment under AASM rules, but not under CMS rules. Sleep laboratory records of 112 consecutive patients were reviewed (85 < 65, 27 ≥ 65 years old). AHI was calculated both by AASM and by CMS criteria. Information on demographics, and important comorbidities, was also reviewed. AHI was lower in younger patients using CMS criteria. However, differences in AHI using the two sets of criteria were not significantly different in the older patients. Incorporating all criteria for eligibility (severity, presence of certain comorbid conditions) for treatment, we found that fewer younger patients would be eligible using CMS criteria, but among the older patients, eligibility for treatment was the same whether AASM or CMS criteria were used. Use of CMS criteria for scoring hypopneas results in lower estimates of OSA severity, with fewer younger patients eligible for treatment. However, among Medicare age patients, the rate of treatment eligibility was the same whether AASM or CMS scoring rules were used.

Patient access to reimbursed biological disease-modifying antirheumatic drugs in the European region.

PubMed

Kaló, Zoltán; Vokó, Zoltán; Östör, Andrew; Clifton-Brown, Emma; Vasilescu, Radu; Battersby, Alysia; Gibson, Edward

2017-01-01

Background & Objectives : Biological disease-modifying antirheumatic drugs (bDMARDs) for the treatment of rheumatoid arthritis (RA) are not always accessible to all patients in accordance with international guidelines, partly owing to their high direct costs against a background of restricted healthcare budgets. This study compares the size of RA patient populations with access to reimbursed bDMARDs across 37 European countries, Russia, and Turkey, according to their treatment eligibility defined by European League Against Rheumatism (EULAR) recommendations and national reimbursement criteria. Methods : The size of the RA patient population eligible for bDMARD treatment was estimated in a population model using published RA epidemiological data and clinical criteria defined by 2013 EULAR recommendations along with national reimbursement criteria defined in a survey of the 39 countries in November 2015. Results : According to EULAR recommendations, 32% of the total RA population in the European region is eligible for bDMARD treatment. However, only an average 59% of this EULAR-eligible population remains eligible after applying national reimbursement criteria (from 86% in 'high access' to 13% in 'low-access' countries). Conclusion : Access to reimbursed bDMARDs remains unequal in the European region. As biosimilars of bDMARDs are introduced, changes in reimbursement criteria may increase access to bDMARDs and reduce this inequality.

Eligibility and utilization of implantable cardioverter-defibrillators in a regional STEMI system.

PubMed

Johnson, Benjamin K; Garberich, Ross F; Henry, Timothy D; Katsiyiannis, William T; Sengupta, Jay; Kalra, Ankur; Hauser, Robert G; Lardy, Meghan E; Newell, Marc C

2016-02-01

Studies have shown mortality benefit for implantable cardioverter-defibrillators (ICDs) in ST-elevation myocardial infarction (STEMI) patients with reduced left ventricular ejection fraction (LVEF), but contemporary eligibility and appropriate utilization of ICDs is unknown. The purpose of this study was to determine the contemporary eligibility and appropriate utilization of ICDs post-STEMI. Using the prospective Minneapolis Heart Institute regional STEMI registry, LVEF before discharge and at follow-up were stratified into 3 groups: normal (LVEF ≥50%), mildly reduced (LVEF 35%-49%), and severely reduced (LVEF <35%). From March 2003 to June 2012, 3626 patients were treated. Patients with in-hospital death (n = 187), ICD in place (n = 21), negative cardiac biomarkers (n = 337), and undocumented in-hospital LVEF (n = 9) were excluded, leaving 3072 patients in the final analysis, including 1833 (59.7%) with LVEF ≥50%, 875 (28.5%) with LVEF between 35% and 49%, and 364 (11.8%) with LVEF <35% before hospital discharge. Overall, 1029 patients (33.5%) underwent follow-up echocardiography ≥40 days post-STEMI, including 140 of the 364 patients (38.5%) discharged with LVEF <35%. In total, 73 patients (7.1%) with follow-up echocardiography ≥40 days post-STEMI met criteria for an ICD (68 LVEF ≤30%, 5 LVEF 30%-35%, and New York Heart Association class II or greater). Only 26 of these patients (35.6%) underwent ICD placement within 1 year post-STEMI. Overall, only 10% to 15% of potentially eligible patients had an ICD implemented. Rates of ICD implantation in appropriate STEMI patients after 40 days are low. Strategies are needed to identify and expand access to these high-risk patients. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

High early event rates in patients with questionable eligibility for advanced heart failure therapies: Results from the Medical Arm of Mechanically Assisted Circulatory Support (Medamacs) Registry.

PubMed

Ambardekar, Amrut V; Forde-McLean, Rhondalyn C; Kittleson, Michelle M; Stewart, Garrick C; Palardy, Maryse; Thibodeau, Jennifer T; DeVore, Adam D; Mountis, Maria M; Cadaret, Linda; Teuteberg, Jeffrey J; Pamboukian, Salpy V; Cantor, Ryan S; Lindenfeld, JoAnn

2016-06-01

The prognosis of ambulatory patients with advanced heart failure (HF) who are not yet inotrope dependent and implications for evaluation and timing for transplant or destination therapy with a left ventricular assist device (DT-LVAD) are unknown. We hypothesized that the characteristics defining eligibility for advanced HF therapies would be a primary determinant of outcomes in these patients. Ambulatory patients with advanced HF (New York Heart Association class III-IV, Interagency Registry for Mechanically Assisted Circulatory Support profiles 4-7) were enrolled across 11 centers from May 2013 to February 2015. Patients were stratified into 3 groups: likely transplant eligible, DT-LVAD eligible, and ineligible for both transplant and DT-LVAD. Clinical characteristics were collected, and patients were prospectively followed for death, transplant, and left ventricular assist device implantation. The study enrolled 144 patients with a mean follow-up of 10 ± 6 months. Patients in the ineligible cohort (n = 43) had worse congestion, renal function, and anemia compared with transplant (n = 51) and DT-LVAD (n = 50) eligible patients. Ineligible patients had higher mortality (23.3% vs 8.0% in DT-LVAD group and 5.9% in transplant group, p = 0.02). The differences in mortality were related to lower rates of transplantation (11.8% in transplant group vs 2.0% in DT-LVAD group and 0% in ineligible group, p = 0.02) and left ventricular assist device implantation (15.7% in transplant group vs 2.0% in DT-LVAD group and 0% in ineligible group, p < 0.01). Ambulatory patients with advanced HF who were deemed ineligible for transplant and DT-LVAD had markers of greater HF severity and a higher rate of mortality compared with patients eligible for transplant or DT-LVAD. The high early event rate in this group emphasizes the need for timely evaluation and decision making regarding lifesaving therapies. Copyright © 2016 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

ClinicalTrials.gov as a data source for semi-automated point-of-care trial eligibility screening.

PubMed

Pfiffner, Pascal B; Oh, JiWon; Miller, Timothy A; Mandl, Kenneth D

2014-01-01

Implementing semi-automated processes to efficiently match patients to clinical trials at the point of care requires both detailed patient data and authoritative information about open studies. To evaluate the utility of the ClinicalTrials.gov registry as a data source for semi-automated trial eligibility screening. Eligibility criteria and metadata for 437 trials open for recruitment in four different clinical domains were identified in ClinicalTrials.gov. Trials were evaluated for up to date recruitment status and eligibility criteria were evaluated for obstacles to automated interpretation. Finally, phone or email outreach to coordinators at a subset of the trials was made to assess the accuracy of contact details and recruitment status. 24% (104 of 437) of trials declaring on open recruitment status list a study completion date in the past, indicating out of date records. Substantial barriers to automated eligibility interpretation in free form text are present in 81% to up to 94% of all trials. We were unable to contact coordinators at 31% (45 of 146) of the trials in the subset, either by phone or by email. Only 53% (74 of 146) would confirm that they were still recruiting patients. Because ClinicalTrials.gov has entries on most US and many international trials, the registry could be repurposed as a comprehensive trial matching data source. Semi-automated point of care recruitment would be facilitated by matching the registry's eligibility criteria against clinical data from electronic health records. But the current entries fall short. Ultimately, improved techniques in natural language processing will facilitate semi-automated complex matching. As immediate next steps, we recommend augmenting ClinicalTrials.gov data entry forms to capture key eligibility criteria in a simple, structured format.

Improvement in Herpes Zoster Vaccination in Patients with Rheumatoid Arthritis: A Quality Improvement Project.

PubMed

Sheth, Heena; Moreland, Larry; Peterson, Hilary; Aggarwal, Rohit

2017-01-01

To improve herpes zoster (HZ) vaccination rates in high-risk patients with rheumatoid arthritis (RA) being treated with immunosuppressive therapy. This quality improvement project was based on the pre- and post-intervention design. The project targeted all patients with RA over the age of 60 years while being treated with immunosuppressive therapy (not with biologics) seen in 13 rheumatology outpatient clinics. The study period was from July 2012 to June 2013 for the pre-intervention and February 2014 to January 2015 for the post-intervention phase. The electronic best practice alert (BPA) for HZ vaccination was developed; it appeared on electronic medical records during registration and medication reconciliation of the eligible patient by the medical assistant. The BPA was designed to electronically identify patient eligibility and to enable the physician to order the vaccine or to document refusal or deferral reason. Education regarding vaccine guidelines, BPA, vaccination process, and feedback were crucial components of the project interventions. The vaccination rates were compared using the chi-square test. We evaluated 1823 and 1554 eligible patients with RA during the pre-intervention and post-intervention phases, respectively. The HZ vaccination rates, reported as patients vaccinated among all eligible patients, improved significantly from the pre-intervention period of 10.1% (184/1823) to 51.7% (804/1554) during the intervention phase (p < 0.0001). The documentation rates (vaccine received, vaccine ordered, patient refusal, and deferral reasons) increased from 28% (510/1823) to 72.9% (1133/1554; p < 0.0001). The HZ infection rates decreased significantly from 2% to 0.3% (p = 0.002). Electronic identification of vaccine eligibility and BPA significantly improved HZ vaccination rates. The process required minimal modification of clinic work flow and did not burden the physician's time, and has the potential for self-sustainability and generalizability.

Use of Hydralazine‐Isosorbide Dinitrate Combination in African American and Other Race/Ethnic Group Patients With Heart Failure and Reduced Left Ventricular Ejection Fraction

PubMed Central

Golwala, Harsh B.; Thadani, Udho; Liang, Li; Stavrakis, Stavros; Butler, Javed; Yancy, Clyde W.; Bhatt, Deepak L.; Hernandez, Adrian F.; Fonarow, Gregg C.

2013-01-01

Background Hydralazine‐isosorbide dinitrate (H‐ISDN) therapy is recommended for African American patients with moderate to severe heart failure with reduced ejection fraction (<40%) (HFrEF), but use, temporal trends, and clinical characteristics associated with H‐ISDN therapy in clinical practice are unknown. Methods and Results An observational analysis of 54 622 patients admitted with HFrEF and discharged home from 207 hospitals participating in the Get With The Guidelines–Heart Failure registry from April 2008 to March 2012 was conducted to assess prescription, trends, and predictors of use of H‐ISDN among eligible patients. Among 11 185 African American patients eligible for H‐ISDN therapy, only 2500 (22.4%) received H‐ISDN therapy at discharge. In the overall eligible population, 5115 of 43 498 (12.6%) received H‐ISDN at discharge. Treatment rates increased over the study period from 16% to 24% among African Americans and from 10% to 13% among the entire HFrEF population. In a multivariable model, factors associated with H‐ISDN use among the entire cohort included younger age; male sex; African American/Hispanic ethnicity; and history of diabetes, hypertension, anemia, renal insufficiency, higher systolic blood pressure, and lower heart rate. In African American patients, these factors were similar; in addition, being uninsured was associated with lower use. Conclusions Overall, few potentially eligible patients with HFrEF are treated with H‐ISDN, and among African‐Americans fewer than one‐fourth of eligible patients received guideline‐recommended H‐ISDN therapy. Improved ways to facilitate use of H‐ISDN therapy in African American patients with HFrEF are needed. PMID:23966379

Diminishing availability of publicly funded slots for antiretroviral initiation among HIV-infected ART-eligible patients in Uganda.

PubMed

Geng, Elvin H; Bwana, Mwebesa B; Kabakyenga, Jerome; Muyindike, Winnie; Emenyonu, Nneka I; Musinguzi, Nicholas; Mugyenyi, Peter; Martin, Jeffrey N; Bangsberg, David R

2010-11-24

The impact of flat-line funding in the global scale up of antiretroviral therapy (ART) for HIV-infected patients in Africa has not yet been well described. We evaluated ART-eligible patients and patients starting ART at a prototypical scale up ART clinic in Mbarara, Uganda between April 1, 2009 and May 14, 2010 where four stakeholders sponsor treatment - two PEPFAR implementing organizations, the Ugandan Ministry of Health - Global Fund (MOH-GF) and a private foundation named the Family Treatment Fund (FTF). We assessed temporal trends in the number of eligible patients, the number starting ART and tabulated the distribution of the stakeholders supporting ART initiation by month and quartile of time during this interval. We used survival analyses to assess changes in the rate of ART initiation over calendar time. A total of 1309 patients who were eligible for ART made visits over the 14 month period of the study and of these 819 started ART. The median number of ART eligible patients each month was 88 (IQR: 74 to 115). By quartile of calendar time, PEPFAR and MOH sponsored 290, 192, 180, and 49 ART initiations whereas the FTF started 1, 2, 1 and 104 patients respectively. By May of 2010 (the last calendar month of observation) FTF sponsored 88% of all ART initiations. Becoming eligible for ART in the 3(rd) (HR = 0.58, 95% 0.45-0.74) and 4(th) quartiles (HR = 0.49, 95% CI: 0.36-0.65) was associated with delay in ART initiation compared to the first quartile in multivariable analyses. During a period of flat line funding from multinational donors for ART programs, reductions in the number of ART initiations by public programs (i.e., PEPFAR and MOH-GF) and delays in ART initiation became apparent at the a large prototypical scale-up ART clinic in Uganda.

Use of a web-based survey to facilitate shared decision making for patients eligible for cancer screening.

PubMed

Brackett, Charles D; Kearing, Stephen

2015-04-01

Our aim was to facilitate shared decision making (SDM) during preventive visits by utilizing a web-based survey system to offer colorectal cancer (CRC) and prostate cancer screening decision aids (DAs) to appropriately identified patients prior to the visit. Patients completed a web-based questionnaire before their preventive medicine appointment. Age- and gender-appropriate patients completed additional questions to determine eligibility for CRC or prostate-specific antigen (PSA) screening. Eligible patients were offered a choice of video or print DA, and completed questions assessing their knowledge, values, and preferences regarding the screening decision. Responses were summarized and fed forward to clinician and patient reports. Overall, 11,493 CRC and 4,384 PSA questionnaires were completed. Patient responses were used to identify those eligible for cancer-screening DAs: 2,187 (19 %) for CRC and 2,962 (68 %) for PSA; 15 % of eligible patients requested a DA. Many patients declined a DA because they indicated they "already know enough to make their decision" (34 % for CRC, 46 % for PSA). A web-based questionnaire provides an efficient means to identify patients eligible for cancer screening decisions and to offer them DAs before an appointment. Pre-visit use of DAs along with reports giving feedback to patients and clinicians provides an opportunity for SDM to occur at the visit.

Understanding variations in patient screening and recruitment in a multicentre pilot randomised controlled trial: a vignette-based study.

PubMed

Hilton, Paul; Buckley, Brian S; McColl, Elaine; Howel, Denise; Tincello, Douglas G; Brennand, Catherine

2016-10-26

The INVESTIGATE-I study was designed to inform a future definitive randomised trial of invasive urodynamic testing, compared to basic clinical assessment with noninvasive tests prior to surgical treatment, in women with stress urinary incontinence or stress-predominant mixed urinary incontinence. In a pilot randomised controlled trial, women from seven participating sites were screened, consented and randomised. Overall, 771 patients were identified from clinic notes and correspondence as being potential recruits and were sent the Patient Information Leaflet. Of those screened, 284 were deemed eligible, giving an overall 'screen positive' rate of 37 %. The numbers screened at individual centres varied between 14 and 399; the 'screen positive' rate varied between 22 and 79 % and the percentage of eligible women recruited varied between 55 and 100 %. The aim of this additional substudy was to explore why 'screen positive' rates may have varied so widely between apparently similar sites. All 11 trial staff involved in screening in the seven recruiting sites were asked to evaluate a series of 20 identical vignettes, mainly based on actual general practitioner referral letters. Of the vignettes, 16 mentioned one or more definite inclusion criteria; the remainder had possible inclusions. Four had definite exclusions; 12 had possible exclusions. Free-text comments were sought to clarify the screeners' decisions. For six vignettes everyone agreed that the patient was eligible; for one all agreed she was not eligible; the breakdown for the remainder was mixed. Free-text comments illuminated uncertainties that may have led to variability in judging potential eligibility. Variability in judgements about potential trial eligibility highlights the importance of explicit and objective inclusion and exclusion criteria, and of agreed strategies for making judgements when information is missing. During the development and planning of trials, vignettes might be a valuable tool for training those involved in screening and recruiting patients, for identifying potential problems and ensuring greater consistency in the application of eligibility criteria. ISTCTN registry: ISRCTN71327395 , registered on 7 June 2010.

An OPTIMIZE study retrospective analysis for management of telaprevir-treated hepatitis C virus (HCV)-infected patients by use of the Abbott RealTime HCV RNA assay.

PubMed

Sarrazin, Christoph; Dierynck, Inge; Cloherty, Gavin; Ghys, Anne; Janssen, Katrien; Luo, Donghan; Witek, James; Buti, Maria; Picchio, Gaston; De Meyer, Sandra

2015-04-01

Protease inhibitor (PI)-based response-guided triple therapies for hepatitis C virus (HCV) infection are still widely used. Noncirrhotic treatment-naive and prior relapser patients receiving telaprevir-based treatment are eligible for shorter, 24-week total therapy if HCV RNA is undetectable at both weeks 4 and 12. In this study, the concordance in HCV RNA assessments between the Roche High Pure System/Cobas TaqMan and Abbott RealTime HCV RNA assays and the impacts of different HCV RNA cutoffs on treatment outcome were evaluated. A total of 2,629 samples from 663 HCV genotype 1 patients receiving telaprevir/pegylated interferon/ribavirin in OPTIMIZE were analyzed using the High Pure System and reanalyzed using Abbott RealTime (limits of detection, 15.1 IU/ml versus 8.3 IU/ml; limits of quantification, 25 IU/ml versus 12 IU/ml, respectively). Overall, good concordance was observed between the assays. Using undetectable HCV RNA at week 4, 34% of the patients would be eligible for shorter treatment duration with Abbott RealTime versus 72% with the High Pure System. However, using <12 IU/ml for Abbott RealTime, a similar proportion (74%) would be eligible. Of the patients receiving 24-week total therapy, 87% achieved a sustained virologic response with undetectable HCV RNA by the High Pure System or <12 IU/ml by Abbott RealTime; however, 92% of the patients with undetectable HCV RNA by Abbott RealTime achieved a sustained virologic response. Using undetectable HCV RNA as the cutoff, the more sensitive Abbott RealTime assay would identify fewer patients eligible for shorter treatment than the High Pure System. Our data confirm the <12-IU/ml cutoff, as previously established in other studies of the Abbott RealTime assay, to determine eligibility for shortened PI-based HCV treatment. (The study was registered with ClinicalTrials.gov under registration no. NCT01241760.). Copyright © 2015, American Society for Microbiology. All Rights Reserved.

Eligibility for clinical trials in primary Sjögren’s syndrome: lessons from the UK Primary Sjögren’s Syndrome Registry

PubMed Central

Oni, Clare; Mitchell, Sheryl; James, Katherine; Ng, Wan-Fai; Griffiths, Bridget; Hindmarsh, Victoria; Price, Elizabeth; Pease, Colin T.; Emery, Paul; Lanyon, Peter; Jones, Adrian; Bombardieri, Michele; Sutcliffe, Nurhan; Pitzalis, Costantino; Hunter, John; Gupta, Monica; McLaren, John; Cooper, Annie; Regan, Marian; Giles, Ian; Isenberg, David; Saravanan, Vadivelu; Coady, David; Dasgupta, Bhaskar; McHugh, Neil; Young-Min, Steven; Moots, Robert; Gendi, Nagui; Akil, Mohammed; Barone, Francesca; Fisher, Ben; Rauz, Saaeha; Richards, Andrea; Bowman, Simon J.

2016-01-01

Abstract Objective: To identify numbers of participants in the UK Primary Sjögren’s Syndrome Registry (UKPSSR) who would fulfil eligibility criteria for previous/current or potential clinical trials in primary SS (pSS) in order to optimize recruitment. Methods: We did a retrospective analysis of UKPSSR cohort data of 688 participants who had pSS with evaluable data. Results: In relation to previous/current trials, 75.2% fulfilled eligibility for the Belimumab in Subjects with Primary Sjögren’s Syndrome study (Belimumab), 41.4% fulfilled eligibility for the Trial of Remicade in primary Sjögren’s syndrome study (Infliximab), 35.4% for the Efficacy of Tocilizumab in Primary Sjögren’s Syndrome study (Tocilizumab), 46.3% for the Tolerance and Efficacy of Rituximab in Sjögren’s Disease study (Rituximab), 26.9% for the Trial of anti-B-cell therapy in pSS study (Rituximab) and 26.6% for the Efficacy and Safety of Abatacept in Patients With Primary Sjögren’s Syndrome study (Abatacept). If recent measures of outcome, such as the EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) score ⩾5 (measure of patient symptoms) and the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) score ⩾5 (measure of systemic disease activity) are incorporated into a study design, with requirements for an unstimulated salivary flow >0 and anti-Ro positivity, then the pool of eligible participants is reduced to 14.3%. Conclusion: The UKPSSR identified a number of options for trial design, including selection on ESSDAI ⩾5, ESSPRI ⩾5 and serological and other parameters. PMID:26510429

Eligibility for clinical trials in primary Sjögren's syndrome: lessons from the UK Primary Sjögren's Syndrome Registry.

PubMed

Oni, Clare; Mitchell, Sheryl; James, Katherine; Ng, Wan-Fai; Griffiths, Bridget; Hindmarsh, Victoria; Price, Elizabeth; Pease, Colin T; Emery, Paul; Lanyon, Peter; Jones, Adrian; Bombardieri, Michele; Sutcliffe, Nurhan; Pitzalis, Costantino; Hunter, John; Gupta, Monica; McLaren, John; Cooper, Annie; Regan, Marian; Giles, Ian; Isenberg, David; Saravanan, Vadivelu; Coady, David; Dasgupta, Bhaskar; McHugh, Neil; Young-Min, Steven; Moots, Robert; Gendi, Nagui; Akil, Mohammed; Barone, Francesca; Fisher, Ben; Rauz, Saaeha; Richards, Andrea; Bowman, Simon J

2016-03-01

To identify numbers of participants in the UK Primary Sjögren's Syndrome Registry (UKPSSR) who would fulfil eligibility criteria for previous/current or potential clinical trials in primary SS (pSS) in order to optimize recruitment. We did a retrospective analysis of UKPSSR cohort data of 688 participants who had pSS with evaluable data. In relation to previous/current trials, 75.2% fulfilled eligibility for the Belimumab in Subjects with Primary Sjögren's Syndrome study (Belimumab), 41.4% fulfilled eligibility for the Trial of Remicade in primary Sjögren's syndrome study (Infliximab), 35.4% for the Efficacy of Tocilizumab in Primary Sjögren's Syndrome study (Tocilizumab), 31.6% for the Tolerance and Efficacy of Rituximab in Sjögren's Disease study (Rituximab), 26.9% for the Trial of anti-B-cell therapy in pSS study (Rituximab) and 26.6% for the Efficacy and Safety of Abatacept in Patients With Primary Sjögren's Syndrome study (Abatacept). If recent measures of outcome, such as the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score ⩾5 (measure of patient symptoms) and the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ⩾5 (measure of systemic disease activity) are incorporated into a study design, with requirements for an unstimulated salivary flow >0 and anti-Ro positivity, then the pool of eligible participants is reduced to 14.3%. The UKPSSR identified a number of options for trial design, including selection on ESSDAI ⩾5, ESSPRI ⩾5 and serological and other parameters. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Exploratory Analysis of Time from HIV Diagnosis to ART Start, Factors and effect on survival: A longitudinal follow up study at seven teaching hospitals in Ethiopia.

PubMed

Teklu, Alula M; Delele, Kesetebirhan; Abraha, Mulu; Belayhun, Bekele; Gudina, Esayas Kebede; Nega, Abiy

2017-02-01

The HIV care in Ethiopia has reached 79% coverage. The timeliness of the care provided at the different levels in the course of the disease starting from knowing HIV positive status to ART initiation is not well known. This study intends to explore the timing of the care seeking, the care provision and associated factors. This is a longitudinal follow-up study at seven university hospitals. Patients enrolled in HIV care from September 2005 to December 2013 and aged ≥14 years were studied. Different times in the cascade of HIV care were examined including the duration from date HIV diagnosed to enrollment in HIV care, duration from enrollment to eligibility for ART and time from eligibility to initiation of ART. Ordinal logistic regression was used to investigate their determinants while the effect of these periods on survival of patients was determined using cox-proportional hazards regression. 4159 clients were studied. Time to enrollment after HIV test decreased from 39 days in 2005 to 1 day after 2008. It took longer if baseline CD4 was higher, and eligibility for ART was assessed late. Young adults, lower baseline CD4, HIV diagnosis<2008, late enrollment, and early eligibility assessment were associated with early ART initiation. Male gender, advanced disease stage and lower baseline CD4 were consistent risk factors for mortality. Time to enrollment and duration of ART eligibility assessment as well as ART initiation time after eligibility is improving. Further study is required to identify why mortality is slightly increasing after 2010.

Formal Representations of Eligibility Criteria: A Literature Review

PubMed Central

Weng, Chunhua; Tu, Samson W.; Sim, Ida; Richesson, Rachel

2010-01-01

Standards-based, computable knowledge representations for eligibility criteria are increasingly needed to provide computer-based decision support for automated research participant screening, clinical evidence application, and clinical research knowledge management. We surveyed the literature and identified five aspects of eligibility criteria knowledge representations that contribute to the various research and clinical applications: the intended use of computable eligibility criteria, the classification of eligibility criteria, the expression language for representing eligibility rules, the encoding of eligibility concepts, and the modeling of patient data. We consider three of them (expression language, codification of eligibility concepts, and patient data modeling), to be essential constructs of a formal knowledge representation for eligibility criteria. The requirements for each of the three knowledge constructs vary for different use cases, which therefore should inform the development and choice of the constructs toward cost-effective knowledge representation efforts. We discuss the implications of our findings for standardization efforts toward sharable knowledge representation of eligibility criteria. PMID:20034594

Pilot study of a point-of-use decision support tool for cancer clinical trials eligibility.

PubMed

Breitfeld, P P; Weisburd, M; Overhage, J M; Sledge, G; Tierney, W M

1999-01-01

Many adults with cancer are not enrolled in clinical trials because caregivers do not have the time to match the patient's clinical findings with varying eligibility criteria associated with multiple trials for which the patient might be eligible. The authors developed a point-of-use portable decision support tool (DS-TRIEL) to automate this matching process. The support tool consists of a hand-held computer with a programmable relational database. A two-level hierarchic decision framework was used for the identification of eligible subjects for two open breast cancer clinical trials. The hand-held computer also provides protocol consent forms and schemas to further help the busy oncologist. This decision support tool and the decision framework on which it is based could be used for multiple trials and different cancer sites.

Pilot Study of a Point-of-use Decision Support Tool for Cancer Clinical Trials Eligibility

PubMed Central

Breitfeld, Philip P.; Weisburd, Marina; Overhage, J. Marc; Sledge, George; Tierney, William M.

1999-01-01

Many adults with cancer are not enrolled in clinical trials because caregivers do not have the time to match the patient's clinical findings with varying eligibility criteria associated with multiple trials for which the patient might be eligible. The authors developed a point-of-use portable decision support tool (DS-TRIEL) to automate this matching process. The support tool consists of a hand-held computer with a programmable relational database. A two-level hierarchic decision framework was used for the identification of eligible subjects for two open breast cancer clinical trials. The hand-held computer also provides protocol consent forms and schemas to further help the busy oncologist. This decision support tool and the decision framework on which it is based could be used for multiple trials and different cancer sites. PMID:10579605

Evaluation of data completeness in the electronic health record for the purpose of patient recruitment into clinical trials: a retrospective analysis of element presence

PubMed Central

2013-01-01

Background Computerized clinical trial recruitment support is one promising field for the application of routine care data for clinical research. The primary task here is to compare the eligibility criteria defined in trial protocols with patient data contained in the electronic health record (EHR). To avoid the implementation of different patient definitions in multi-site trials, all participating research sites should use similar patient data from the EHR. Knowledge of the EHR data elements which are commonly available from most EHRs is required to be able to define a common set of criteria. The objective of this research is to determine for five tertiary care providers the extent of available data compared with the eligibility criteria of randomly selected clinical trials. Methods Each participating study site selected three clinical trials at random. All eligibility criteria sentences were broken up into independent patient characteristics, which were then assigned to one of the 27 semantic categories for eligibility criteria developed by Luo et al. We report on the fraction of patient characteristics with corresponding structured data elements in the EHR and on the fraction of patients with available data for these elements. The completeness of EHR data for the purpose of patient recruitment is calculated for each semantic group. Results 351 eligibility criteria from 15 clinical trials contained 706 patient characteristics. In average, 55% of these characteristics could be documented in the EHR. Clinical data was available for 64% of all patients, if corresponding data elements were available. The total completeness of EHR data for recruitment purposes is 35%. The best performing semantic groups were ‘age’ (89%), ‘gender’ (89%), ‘addictive behaviour’ (74%), ‘disease, symptom and sign’ (64%) and ‘organ or tissue status’ (61%). No data was available for 6 semantic groups. Conclusions There exists a significant gap in structure and content between data documented during patient care and data required for patient eligibility assessment. Nevertheless, EHR data on age and gender of the patient, as well as selected information on his disease can be complete enough to allow for an effective support of the manual screening process with an intelligent preselection of patients and patient data. PMID:23514203

Expanding Eligibility for the Ross Procedure: A Reasonable Proposition?

PubMed

Ghoneim, Aly; Bouhout, Ismail; Losenno, Katie; Poirier, Nancy; Cartier, Raymond; Demers, Philippe; Tousch, Michael; Guo, Linruo; Chu, Michael W A; El-Hamamsy, Ismail

2018-06-01

Although the Ross procedure offers potential benefits in young adults, technical complexity represents a significant limitation. Therefore, the safety of expanding its use in more complex settings is uncertain. The aim of this study was to compare early outcomes of standard isolated Ross procedures vs expanding elgibility to higher-risk clinical settings. From 2011 to 2016, 261 patients (46 ± 12 years) underwent Ross procedures in 2 centres. Patients were divided into 2 groups: standard Ross (n = 166) and expanded eligibility Ross (n = 95). Inclusion criteria for the expanded eligibility group were previous cardiac surgery, acute aortic valve endocarditis, severely impaired left ventricular (LV) function and patients undergoing concomitant procedures. All data were prospectively collected and are 100% complete. Hospital mortality was 0% in the standard group (0/166) vs 2% in the expanded eligibility group (2/95) (P = 0.13). Sixteen patients (10%) developed acute renal injury in the standard group vs 13 (14%) patients in the expanded eligibility group (P = 0.31). There were no postoperative myocardial infarctions, no neurological events, and no infectious complications. Median intensive care unit (ICU) stay in the standard group was 2 vs 3 days in the expanded eligibility group (P = 0.004), whereas median hospital stay was 6 vs 7 days, respectively (range: 3-19 days) (P < 0.001). Aside from longer ICU and hospital lengths of stay after the Ross procedure in higher-risk clinical scenarios, perioperative mortality and morbidity is similar to standard Ross procedures. Expanding the use of the Ross operation in young adults is a safe alternative in centres of expertise. Copyright © 2018 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Eligibility for interventions, co-occurrence and risk factors for unhealthy behaviours in patients consulting for routine primary care: results from the Pre-Empt study.

PubMed

Randell, Elizabeth; Pickles, Timothy; Simpson, Sharon A; Spanou, Clio; McCambridge, Jim; Hood, Kerenza; Butler, Christopher C

2015-10-09

Smoking, excessive drinking, lack of exercise and a poor diet remain key causes of premature morbidity and mortality globally, yet it is not clear what proportion of patients attending for routine primary care are eligible for interventions about these behaviours, the extent to which they co-occur within individuals, and which individuals are at greatest risk for multiple unhealthy behaviours. The aim of the trial was to examine 'intervention eligibility' and co-occurrence of the 'big four' risky health behaviours - lack of exercise, smoking, an unhealthy diet and excessive drinking - in a primary care population. Data were collected from adult patients consulting routinely in general practice across South Wales as part of the Pre-Empt study; a cluster randomised controlled trial. After giving consent, participants completed screening instruments, which included the following to assess eligibility for an intervention based on set thresholds: AUDIT-C (for alcohol), HSI (for smoking), IPAQ (for exercise) and a subset of DINE (for diet). The intervention following screening was based on which combination of risky behaviours the patient had. Descriptive statistics, χ2 tests for association and ordinal regressions were undertaken. Two thousand sixty seven patients were screened: mean age of 48.6 years, 61.9 % female and 42.8 % in a managerial or professional occupation. In terms of numbers of risky behaviours screened eligible for, two was the most common (43.6 %), with diet and exercise (27.2 %) being the most common combination. Insufficient exercise was the most common single risky behaviour (12.0 %). 21.8 % of patients would have been eligible for an intervention for three behaviours and 5.9 % for all four behaviours. Just 4.5 % of patients did not identify any risky behaviours. Women, older age groups and those in managerial or professional occupations were more likely to exhibit all four risky behaviours. Very few patients consulting for routine primary care screen ineligible for interventions about common unhealthy behaviours, and most engage in more than one of the major common unhealthy behaviours. Clinicians should be particularly alert to opportunities to engaging younger, non professional men and those with multi-morbidity about risky health behaviour. ISRCTN22495456.

The value of structured data elements from electronic health records for identifying subjects for primary care clinical trials.

PubMed

Ateya, Mohammad B; Delaney, Brendan C; Speedie, Stuart M

2016-01-11

An increasing number of clinical trials are conducted in primary care settings. Making better use of existing data in the electronic health records to identify eligible subjects can improve efficiency of such studies. Our study aims to quantify the proportion of eligibility criteria that can be addressed with data in electronic health records and to compare the content of eligibility criteria in primary care with previous work. Eligibility criteria were extracted from primary care studies downloaded from the UK Clinical Research Network Study Portfolio. Criteria were broken into elemental statements. Two expert independent raters classified each statement based on whether or not structured data items in the electronic health record can be used to determine if the statement was true for a specific patient. Disagreements in classification were discussed until 100 % agreement was reached. Statements were also classified based on content and the percentages of each category were compared to two similar studies reported in the literature. Eligibility criteria were retrieved from 228 studies and decomposed into 2619 criteria elemental statements. 74 % of the criteria elemental statements were considered likely associated with structured data in an electronic health record. 79 % of the studies had at least 60 % of their criteria statements addressable with structured data likely to be present in an electronic health record. Based on clinical content, most frequent categories were: "disease, symptom, and sign", "therapy or surgery", and "medication" (36 %, 13 %, and 10 % of total criteria statements respectively). We also identified new criteria categories related to provider and caregiver attributes (2.6 % and 1 % of total criteria statements respectively). Electronic health records readily contain much of the data needed to assess patients' eligibility for clinical trials enrollment. Eligibility criteria content categories identified by our study can be incorporated as data elements in electronic health records to facilitate their integration with clinical trial management systems.

Eligibility of sacubitril-valsartan in a real-world heart failure population: a community-based single-centre study.

PubMed

Norberg, Helena; Bergdahl, Ellinor; Lindmark, Krister

2018-04-01

This study aims to investigate the eligibility of the Prospective Comparison of Angiotensin Receptor-Neprilysin Inhibitor (ARNI) with ACE inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) study to a real-world heart failure population. Medical records of all heart failure patients living within the catchment area of Umeå University Hospital were reviewed. This district consists of around 150 000 people. Out of 2029 patients with a diagnosis of heart failure, 1924 (95%) had at least one echocardiography performed, and 401 patients had an ejection fraction of ≤35% at their latest examination. The major PARADIGM-HF criteria were applied, and 95 patients fulfilled all enrolment criteria and thus were eligible for sacubitril-valsartan. This corresponds to 5% of the overall heart failure population and 24% of the population with ejection fraction ≤ 35%. The eligible patients were significantly older (73.2 ± 10.3 vs. 63.8 ± 11.5 years), had higher blood pressure (128 ± 17 vs. 122 ± 15 mmHg), had higher heart rate (77 ± 17 vs. 72 ± 12 b.p.m.), and had more atrial fibrillation (51.6% vs. 36.2%) than did the PARADIGM-HF population. Only 24% of our real-world heart failure and reduced ejection fraction population was eligible for sacubitril-valsartan, and the real-world heart failure and reduced ejection fraction patients were significantly older than the PARADIGM-HF population. The lack of data on a majority of the patients that we see in clinical practice is a real problem, and we are limited to extrapolation of results on a slightly different population. This is difficult to address, but perhaps registry-based randomized clinical trials will help to solve this issue. © 2018 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

Representativeness of the dabigatran, apixaban and rivaroxaban clinical trial populations to real-world atrial fibrillation patients in the United Kingdom: a cross-sectional analysis using the General Practice Research Database

PubMed Central

Lee, Sally; Monz, Brigitta U; Clemens, Andreas; Brueckmann, Martina; Lip, Gregory Y H

2012-01-01

Objective Three oral anticoagulants have reported study results for stroke prevention in patients with atrial fibrillation (AF) (dabigatran etexilate, rivaroxaban and apixaban); all demonstrated superiority or non-inferiority compared with warfarin (RE-LY, ARISTOTLE and ROCKET-AF). This study aimed to assess the representativeness for the real-world AF population, particularly the population eligible for anticoagulants. Design A cross-sectional database analysis. Setting Dataset derived from the General Practice Research Database (GPRD). Primary and secondary outcomes measure The proportion of real-world patients with AF who met the inclusion/exclusion criteria for RE-LY, ARISTOTLE and ROCKET-AF were compared. The results were then stratified by risk of stroke using CHADS2 and CHA2DS2-VASc. Results 83 898 patients with AF were identified in the GPRD. For the population at intermediate or high risk of stroke and eligible for anticoagulant treatment (CHA2DS2-VASc ≥1; n=78 783 (94%)), the proportion eligible for inclusion into RE-LY (dabigatran etexilate) was 68% (95% CI 67.7% to 68.3%; n=53 640), compared with 65% (95% CI 64.7% to 65.3%; n=51 163) eligible for ARISTOTLE (apixaban) and 51% (95% CI 50.7% to 51.4%; n=39 892) eligible for ROCKET-AF (rivaroxaban). Using the CHADS2 method of risk stratification, for the population at intermediate or high risk of stroke and eligible for anticoagulation treatment (CHADS2 ≥1; n=71 493 (85%)), the proportion eligible for inclusion into RE-LY was 74% (95% CI 73.7% to 74.3%; n=52 783), compared with 72% (95% CI 71.7% to 72.3%; n=51 415) for ARISTOTLE and 56% (95% CI 55.6% to 56.4%; n=39 892) for ROCKET-AF. Conclusions Patients enrolled within RE-LY and ARISTOTLE were more reflective of the ‘real-world’ AF population in the UK, in contrast with patients enrolled within ROCKET-AF who were a more narrowly defined group of patients at higher risk of stroke. Differences between trials should be taken into account when considering the applicability of findings from randomised clinical trials. However, assessing representativeness is not a substitute for assessing generalisibility, that is, how well clinical trial results would translate into effectiveness and safety in everyday routine care. PMID:23242482

Proportion of patients needing an implantable cardioverter defibrillator on the basis of current guidelines: impact on healthcare resources in Italy and the USA. Data from the ALPHA study registry.

PubMed

Pedretti, Roberto F E; Curnis, Antonio; Massa, Riccardo; Morandi, Fabrizio; Tritto, Massimo; Manca, Lorenzo; Occhetta, Eraldo; Molon, Giulio; De Ferrari, Gaetano M; Sarzi Braga, Simona; Raciti, Giovanni; Klersy, Catherine; Salerno-Uriarte, Jorge A

2010-08-01

Implantable cardioverter defibrillators (ICD) improve survival in selected patients with left ventricular dysfunction or heart failure (HF). The objective is to estimate the number of ICD candidates and to assess the potential impact on public health expenditure in Italy and the USA. Data from 3513 consecutive patients (ALPHA study registry) were screened. A model based on international guidelines inclusion criteria and epidemiological data was used to estimate the number of eligible patients. A comparison with current ICD implant rate was done to estimate the necessary incremental rate to treat eligible patients within 5 years. Up to 54% of HF patients are estimated to be eligible for ICD implantation. An implantation policy based on guidelines would significantly increase the ICD number to 2671 implants per million inhabitants in Italy and to 4261 in the USA. An annual increment of prophylactic ICD implants of 20% in the USA and 68% in Italy would be necessary to treat all indicated patients in a 5-year timeframe. Implantable cardioverter defibrillator implantation policy based on current evidence may have significant impact on public health expenditure. Effective risk stratification may be useful in order to maximize benefit of ICD therapy and its cost-effectiveness in primary prevention.

Management of haemothoraces in blunt thoracic trauma: study protocol for a randomised controlled trial

PubMed Central

Carver, David A; Bressan, Alexsander K; Schieman, Colin; Grondin, Sean C; Kirkpatrick, Andrew W; Lall, Rohan; McBeth, Paul B; Dunham, Michael B; Ball, Chad G

2018-01-01

Introduction Haemothorax following blunt thoracic trauma is a common source of morbidity and mortality. The optimal management of moderate to large haemothoraces has yet to be defined. Observational data have suggested that expectant management may be an appropriate strategy in stable patients. This study aims to compare the outcomes of patients with haemothoraces following blunt thoracic trauma treated with either chest drainage or expectant management. Methods and analysis This is a single-centre, dual-arm randomised controlled trial. Patients presenting with a moderate to large sized haemothorax following blunt thoracic trauma will be assessed for eligibility. Eligible patients will then undergo an informed consent process followed by randomisation to either (1) chest drainage (tube thoracostomy) or (2) expectant management. These groups will be compared for the rate of additional thoracic interventions, major thoracic complications, length of stay and mortality. Ethics and dissemination This study has been approved by the institution’s research ethics board and registered with ClinicalTrials.gov. All eligible participants will provide informed consent prior to randomisation. The results of this study may provide guidance in an area where there remains significant variation between clinicians. The results of this study will be published in peer-reviewed journals and presented at national and international conferences. Trial registration number NCT03050502. PMID:29502092

Impact of state-specific Medicaid reimbursement and eligibility policies on receipt of cancer screening.

PubMed

Halpern, Michael T; Romaire, Melissa A; Haber, Susan G; Tangka, Florence K; Sabatino, Susan A; Howard, David H

2014-10-01

Although state Medicaid programs cover cancer screening, Medicaid beneficiaries are less likely to be screened for cancer and are more likely to present with tumors of an advanced stage than are those with other insurance. The current study was performed to determine whether state Medicaid eligibility and reimbursement policies affect the receipt of breast, cervical, and colon cancer screening among Medicaid beneficiaries. Cross-sectional regression analyses of 2007 Medicaid data from 46 states and the District of Columbia were performed to examine associations between state-specific Medicaid reimbursement/eligibility policies and receipt of cancer screening. The study sample included individuals aged 21 years to 64 years who were enrolled in fee-for-service Medicaid for at least 4 months. Subsamples eligible for each screening test were: Papanicolaou test among 2,136,511 patients, mammography among 792,470 patients, colonoscopy among 769,729 patients, and fecal occult blood test among 753,868 patients. State-specific Medicaid variables included median screening test reimbursement, income/financial asset eligibility requirements, physician copayments, and frequency of eligibility renewal. Increases in screening test reimbursement demonstrated mixed associations (positive and negative) with the likelihood of receiving screening tests among Medicaid beneficiaries. In contrast, increased reimbursements for office visits were found to be positively associated with the odds of receiving all screening tests examined, including colonoscopy (odds ratio [OR], 1.07; 95% confidence interval [95% CI], 1.06-1.08), fecal occult blood test (OR, 1.09; 95% CI, 1.08-1.10), Papanicolaou test (OR, 1.02; 95% CI, 1.02-1.03), and mammography (OR, 1.02; 95% CI, 1.02-1.03). Effects of other state-specific Medicaid policies varied across the screening tests examined. Increased reimbursement for office visits was consistently associated with an increased likelihood of being screened for cancer, and may be an important policy tool for increasing screening among this vulnerable population. © 2014 American Cancer Society.

Anatomy-based eligibility measure for robotic-assisted bypass surgery.

PubMed

Escoto, Abelardo; Trejos, Ana Luisa; Patel, Rajni V; Goela, Aashish; Kiaii, Bob

2014-01-01

Robotic-assisted endoscopic single-vessel small thoracotomy allows clinicians to perform coronary artery bypass grafting surgery in a minimally invasive manner using the da Vinci Surgical System. Not all patients are suitable for this technique, and the lack of an appropriate method for patient eligibility avoids completion of the procedure robotically. The objective of this study was to develop a patient eligibility method based on the anatomy of the chest of the patient. Preoperative computed tomography thorax scans of 110 patients were analyzed. Two-dimensional measurements taken on the axial images were used with the goal of finding a relation between the anatomy of the patient and the completion of the procedure robotically. Patients with a distance from the left anterior descending coronary artery to the anterior chest wall of smaller than 15 mm have a 20% probability of requiring conversion of the procedure to open surgery. This probability increases if the chest of the patient is very elliptical, having an anterior-posterior dimension of less than 45% of the transverse dimension. The smaller the distance is from the left anterior descending artery to the anterior chest wall, the lower the chances are of completing the procedure robotically.

Implementation of a Process for Initial Transcranial Doppler Ultrasonography in Children With Sickle Cell Anemia.

PubMed

Crosby, Lori E; Joffe, Naomi E; Davis, Blair; Quinn, Charles T; Shook, Lisa; Morgan, Darice; Simmons, Kenya; Kalinyak, Karen A

2016-07-01

Stroke, a devastating complication of sickle cell anemia (SCA), can cause irreversible brain injury with physical and cognitive deficits. Transcranial Doppler ultrasonography (TCD) is a non-invasive tool for identifying children with SCA at highest risk of stroke. National guidelines recommend that TCD screening begin at age 2 years, yet there is research to suggest less than half of young children undergo screening. The purpose of this project was to use quality improvement methods to improve the proportion of patients aged 24-27 months who successfully completed their initial TCD from 25% to 75% by December 31, 2013. Quality improvement methods (e.g., process mapping, simplified failure mode effect analysis, and plan-do-study-act cycles) were used to develop and test processes for identifying eligible patients, scheduling TCDs, preparing children and families for the first TCD, and monitoring outcomes (i.e., TCD protocol). Progress was tracked using a report of eligible patients and a chart showing the age in months for the first successful TCD (population metric). As of December 2013, 100% of eligible patients successfully completed their initial TCD screen; this improvement was maintained for the next 20 months. In November 2014, a Welch's one-way ANOVA was conducted. Results showed a statistically significant difference between the average age of first TCD for eligible patients born in 2009 and eligible patients born during the intervention period (2010-2013; F[1,11.712]=16.03, p=0.002). Use of quality improvement methods to implement a TCD protocol was associated with improved TCD screening rates in young children with SCA. Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Case report: patient portal versus telephone recruitment for a surgical research study.

PubMed

Baucom, R B; Ousley, J; Poulose, B K; Rosenbloom, S T; Jackson, G P

2014-01-01

Patient portal adoption has rapidly increased over the last decade. Most patient portal research has been done in primary care or medical specialties, and few studies have examined their use in surgical patients or for recruiting research subjects. No known studies have compared portal messaging with other approaches of recruitment. This case report describes our experience with patient portal versus telephone recruitment for a study involving long-term follow up of surgical patients. Participants were recruited for a study of recurrence after ventral hernia repair through telephone calls and patient portal messaging based on registration status with the portal. Potential subjects who did not have a portal account or whose portal messages were returned after 5 days were called. The proportion of participants enrolled with each method was determined and demographics of eligible patients, portal users, and participants were compared. 1359 patients were eligible for the hernia study, and enrollment was 35% (n=465). Most participants were recruited by telephone (84%, n=391); 16% (n=74) were recruited through portal messaging. Forty-four percent of eligible participants had a registered portal account, and 14% of users responded to the recruitment message. Portal users were younger than non-users (55 vs. 58 years, p<0.001); participants recruited through the portal versus telephone were also younger (54 vs. 59 years, p=0.001). Differences in the sex and racial distributions between users and non-users and between portal and telephone recruits were not significant. Portal versus telephone recruitment for a surgical research study demonstrated modest portal recruitment rates and similar demographics between recruitment methods. Published studies of portal-only recruitment in primary care or medical-specialty patient populations have demonstrated higher enrollment rates, but this case study demonstrates that portal recruitment for research studies in the surgical population is feasible, and it offers convenience to patients and researchers.

Supplementing electronic health records through sample collection and patient diaries: A study set within a primary care research database.

PubMed

Joseph, Rebecca M; Soames, Jamie; Wright, Mark; Sultana, Kirin; van Staa, Tjeerd P; Dixon, William G

2018-02-01

To describe a novel observational study that supplemented primary care electronic health record (EHR) data with sample collection and patient diaries. The study was set in primary care in England. A list of 3974 potentially eligible patients was compiled using data from the Clinical Practice Research Datalink. Interested general practices opted into the study then confirmed patient suitability and sent out postal invitations. Participants completed a drug-use diary and provided saliva samples to the research team to combine with EHR data. Of 252 practices contacted to participate, 66 (26%) mailed invitations to patients. Of the 3974 potentially eligible patients, 859 (22%) were at participating practices, and 526 (13%) were sent invitations. Of those invited, 117 (22%) consented to participate of whom 86 (74%) completed the study. We have confirmed the feasibility of supplementing EHR with data collected directly from patients. Although the present study successfully collected essential data from patients, it also underlined the requirement for improved engagement with both patients and general practitioners to support similar studies. © 2017 The Authors. Pharmacoepidemiology & Drug Safety published by John Wiley & Sons Ltd.

Characteristics and management of patients with chronic hepatitis B in an integrated care setting.

PubMed

Sarkar, Monika; Shvachko, Valentina A; Ready, Joanna B; Pauly, Mary Pat; Terrault, Norah A; Peters, Marion G; Manos, M Michele

2014-09-01

Few population-based studies have described characteristics and management of patients with chronic hepatitis B (CHB) in the USA. We retrospectively studied adults with CHB in the Northern California Kaiser Permanente Medical Care Program (KPNC) from July 2009 to December 2010 (n = 12,016). Laboratory tests, treatment patterns, and hepatocellular carcinoma (HCC) surveillance were ascertained during a "recent" 18-month study window (July 2009-December 2010), or as "ever" based on records dating to 1995. The mean age was 49 years; 51 % were men, 83 % Asian, and 87 % KPNC members >5 years. Overall, 51 % had ≥ 1 liver-related visit, 14 % with gastroenterology or infectious disease specialists, and 37 % with primary care providers (PCP) only. Less than 40 % of patients had both hepatitis B virus (HBV) DNA and ALT testing conducted recently, while 56 % of eligible patients had received HCC surveillance. Recent laboratory testing and HCC surveillance were more frequent in patients seen by a specialist versus PCP only (90 vs. 47 % and 92 vs. 73 %, respectively, p values <0.001). During the study period, 1,649 (14 %) received HBV treatment, while 5 % of untreated patients had evidence of treatment eligibility. Among 599 patients newly initiated on HBV therapy, 76 % had guideline-based indications for treatment. Most patients initiated on HBV treatment met eligibility, and very few patients with evidence of needing treatment were left untreated. However, monitoring of ALT and HBV DNA levels, as well as HCC surveillance, were not frequent, underestimating the proportion of patients that warranted HBV therapy. Viral monitoring and cancer surveillance are therefore important targets for improving the scope of CHB care in the community setting.

Strategies for distributing cancer screening decision aids in primary care.

PubMed

Brackett, Charles; Kearing, Stephen; Cochran, Nan; Tosteson, Anna N A; Blair Brooks, W

2010-02-01

Decision aids (DAs) have been shown to facilitate shared decision making about cancer screening. However, little data exist on optimal strategies for dissemination. Our objective was to compare different decision aid distribution models. Eligible patients received video decision aids for prostate cancer (PSA) or colon cancer screening (CRC) through 4 distribution methods. Outcome measures included DA loans (N), % of eligible patients receiving DA, and patient and provider satisfaction. Automatically mailing DAs to all age/gender appropriate patients led to near universal receipt by screening-eligible patients, but also led to ineligible patients receiving DAs. Three different elective (non-automatic) strategies led to low rates of receipt. Clinician satisfaction was higher when patients viewed the DA before the visit, and this model facilitated implementation of the screening choice. Regardless of timing or distribution method, patient satisfaction was high. An automatic DA distribution method is more effective than relying on individual initiative. Enabling patients to view the DA before the visit is preferred. Systematically offering DAs to all eligible patients before their appointments is the ideal strategy, but may be challenging to implement. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

Improving the Care of Dual Eligible Patients in Rural Federally Qualified Health Centers: The Impact of Care Coordinators and Clinical Pharmacists.

PubMed

Doyle, Daniel; Emmett, Mary; Crist, Amber; Robinson, Craig; Grome, Michael

2016-04-01

Dual eligible persons are those covered by both Medicare and Medicaid. There were 9.6 million dual eligible persons in the United States and 82 000 in West Virginia in 2010. Dual eligibles are poorer, sicker, and more burdened with serious mental health conditions than Medicare or Medicaid patients as a whole. Their health care costs are significantly higher and they are more likely to receive fragmented ineffective care. To improve the care experience and health care outcomes of dual eligible patients by the expanded use of care coordinators and clinical pharmacists. During 2012, 3 rural federally qualified community health centers in West Virginia identified 200 dual eligible patients each. Those with hospitalizations received more frequent care coordinator contacts. Those on more than 15 chronic medications had drug utilization reviews with recommendations to primary care providers. Baseline measures included demographics, chronic diseases, total medications and Beers list medications, hospitalization, and emergency room (ER) use in the previous year. Postintervention measures included hospitalization, ER use, total medications, and Beers list medications. Out of 556 identified patients, 502 were contacted and enrolled. Sixty-five percent were female. The median age was 69 years, with a range of 29 to 93 years. Nineteen percent (19%) of patients were on 15 or more medications, 56% on psychotropic medication, and 33% on chronic opiates. One site showed reductions of 34% in hospitalizations and 25% in ER visits during the intervention year. For all sites combined, there was a 5.5% reduction in total medications and a 14.8% reduction in Beers list medications. A modest investment in care coordination and clinical pharmacy review can produce significant reductions in hospitalization and harmful polypharmacy for community dwelling dual eligible patients. © The Author(s) 2015.

Eligibility for Renal Denervation: Anatomical Classification and Results in Essential Resistant Hypertension

DOE Office of Scientific and Technical Information (OSTI.GOV)

Okada, Takuya, E-mail: okabone@gmail.com; Pellerin, Olivier; Savard, Sébastien

PurposeTo classify the renal artery (RA) anatomy based on specific requirements for endovascular renal artery denervation (RDN) in patients with drug-resistant hypertension (RH).Materials and MethodsThe RA anatomy of 122 consecutive RH patients was evaluated by computed tomography angiography and classified as two types: A (main RA ≥20 mm in length and ≥4.0 mm in diameter) or B (main RA <20 mm in length or main RA <4.0 mm in diameter). The A type included three subtypes: A1 (without accessory RAs), A2 (with accessory RAs <3.0 mm in diameter), and A3 (with accessory RAs ≥3.0 mm in diameter]. A1 and A2 types were eligible for RDN withmore » the Simplicity Flex catheter. Type B included twi subtypes based on the main RA length and diameter. Patients were accordingly classified into three eligibility categories: complete (CE; both RAs were eligible), partial (PE; one eligible RA), and noneligibility (NE; no eligible RA).ResultsBilateral A1 type was the most prevalent and was observed in 48.4 % of the patients followed by the A1/A2 type (18 %). CE, PE, and NE were observed in 69.7, 22.9, and 7.4 % of patients, respectively. The prevalence of accessory RAs was 41 %.ConclusionsOf RH patients, 30.3 % were not eligible for bilateral RDN with the current Simplicity Flex catheter. This classification provides the basis for standardized reporting to allow for pooling of results of larger patient cohorts in the future.« less

Eligibility for renal denervation: experience at 11 European expert centers.

PubMed

Persu, Alexandre; Jin, Yu; Baelen, Marie; Vink, Eva; Verloop, Willemien L; Schmidt, Bernhard; Blicher, Marie K; Severino, Francesca; Wuerzner, Grégoire; Taylor, Alison; Pechère-Bertschi, Antoinette; Jokhaji, Fadi; Fadl Elmula, Fadl Elmula M; Rosa, Jan; Czarnecka, Danuta; Ehret, Georg; Kahan, Thomas; Renkin, Jean; Widimsky, Jiři; Jacobs, Lotte; Spiering, Wilko; Burnier, Michel; Mark, Patrick B; Menne, Jan; Olsen, Michael H; Blankestijn, Peter J; Kjeldsen, Sverre; Bots, Michiel L; Staessen, Jan A

2014-06-01

Based on the SYMPLICITY studies and CE (Conformité Européenne) certification, renal denervation is currently applied as a novel treatment of resistant hypertension in Europe. However, information on the proportion of patients with resistant hypertension qualifying for renal denervation after a thorough work-up and treatment adjustment remains scarce. The aim of this study was to investigate the proportion of patients eligible for renal denervation and the reasons for noneligibility at 11 expert centers participating in the European Network COordinating Research on renal Denervation in treatment-resistant hypertension (ENCOReD). The analysis included 731 patients. Age averaged 61.6 years, office blood pressure at screening was 177/96 mm Hg, and the number of blood pressure-lowering drugs taken was 4.1. Specialists referred 75.6% of patients. The proportion of patients eligible for renal denervation according to the SYMPLICITY HTN-2 criteria and each center's criteria was 42.5% (95% confidence interval, 38.0%-47.0%) and 39.7% (36.2%-43.2%), respectively. The main reasons of noneligibility were normalization of blood pressure after treatment adjustment (46.9%), unsuitable renal arterial anatomy (17.0%), and previously undetected secondary causes of hypertension (11.1%). In conclusion, after careful screening and treatment adjustment at hypertension expert centers, only ≈40% of patients referred for renal denervation, mostly by specialists, were eligible for the procedure. The most frequent cause of ineligibility (approximately half of cases) was blood pressure normalization after treatment adjustment by a hypertension specialist. Our findings highlight that hypertension centers with a record in clinical experience and research should remain the gatekeepers before renal denervation is considered.

Potential Health Implications of the MTM Eligibility Criteria in the Affordable Care Act Across Racial and Ethnic Groups

PubMed Central

Wang, Junling; Qiao, Yanru; Tina Shih, Ya-Chen; Jamison, JoEllen Jarrett; Spivey, Christina A.; Wan, Jim Y.; White-Means, Shelley I.; Dagogo-Jack, Samuel; Cushman, William C.; Chisholm-Burns, Marie

2015-01-01

Background The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) requires Part D plans to establish programs to provide medication therapy management (MTM) services starting from 2006. MTM services have been found to improve patient outcomes from pharmacotherapy, reduce emergency room visits and hospitalizations, and reduce health care costs in a cost-effective fashion. However, previous research found that Non-Hispanic Blacks (Blacks) and Hispanics may be less likely to be eligible for MTM services than Non-Hispanic Whites (Whites) among the Medicare population according to current Medicare MTM eligibility criteria. This is because the Medicare MTM eligibility criteria are predominantly based on medication utilization and costs, while Blacks and Hispanics tend to use fewer prescription medications and incur lower prescription medication costs. The Patient Protection and Affordable Care Act (PPACA) laid out a set of MTM eligibility criteria for eligible entities to target patients for MTM services: “(1) take 4 or more prescribed medications …; (2) take any ‘high risk’ medications; (3) have 2 or more chronic diseases… or (4) have undergone a transition of care, or other factors… that are likely to create a high risk of medication-related problems.” Objectives This study aimed to examine (1) racial/ethnic disparities in meeting the eligibility criteria for MTM services in PPACA among the Medicare population; and (2) whether there would be greater disparities in health and economic outcomes among MTM-ineligible than MTM-eligible groups. (If so, the PPACA MTM eligibility criteria may aggravate existing disparities.) Methods This was a retrospective cross-sectional analysis of Medicare Current Beneficiaries Survey (MCBS; 2007–2008). To determine medication characteristics, the Food and Drug Administration’s Electronic Orange Book was also used. Proportions of population eligible for MTM services based on the PPACA MTM eligibility criteria were compared across racial and ethnic groups using a chi-square test; a logistic regression model was used to adjust for population socio-demographic and health characteristics. Health and economic outcomes examined included health status (self-perceived good health status, number of chronic diseases, activities of daily living or ADLs, and instrumental activities of daily living or IADLs), health services utilization and costs (physician visits, emergency room visits, and total health care costs), and medication utilization patterns (generic dispensing ratio). To determine difference in disparities across MTM eligibility categories, difference-in-differences regressions of various functional forms were employed depending on the nature of the dependent variables. Interaction terms between the dummy variables for minority groups (e.g., Blacks or Hispanics) and MTM eligibility were included to test whether disparity patterns varied between MTM-ineligible and MTM-eligible individuals. Results The sample consisted of 12,966 Medicare beneficiaries, of which 11,161 were White, 930 were Black and 875 were Hispanic. Of the study sample, 9,992 Whites (86.4%), 825 Blacks (86.3%) and 733 Hispanics (80.6%) were eligible for MTM. The difference between Whites and Hispanics was significant (P<0.05) and the difference between Whites and Blacks were not significant (P>0.05). In multivariate analyses, significant disparity in eligibility for MTM services was found only between Hispanics and Whites (OR = 0.59; 95% CI = 0.43–0.82) but not between Blacks and Whites (OR=0.78; 95% CI=0.55–1.09). Disparities were greater among the MTM-ineligible than the MTM-eligible populations in self-perceived health status, ADLs, and IADLs for both Blacks and Hispanics compared with Whites. When analyzing number of chronic conditions, number and costs of physician visits and total healthcare costs, this study found lower racial and ethnic disparities among the non-eligible population than the eligible population. Conclusion Hispanics would be significantly less likely than Whites to qualify for MTM eligibility among the Medicare population according to the MTM eligibility criteria stipulated in PPACA. The PPACA MTM eligibility criteria may aggravate existing racial and ethnic disparities in health status but may remediate racial and ethnic disparities in health services utilization. Alternative MTM eligibility criteria other than PPACA MTM eligibility criteria may be needed to improve the efficiency and equity of access to Medicare Part D MTM programs. PMID:26521111

Instrumental Activities of Daily Living after Critical Illness: A Systematic Review.

PubMed

Hopkins, Ramona O; Suchyta, Mary R; Kamdar, Biren B; Darowski, Emily; Jackson, James C; Needham, Dale M

2017-08-01

Poor functional status is common after critical illness, and can adversely impact the abilities of intensive care unit (ICU) survivors to live independently. Instrumental activities of daily living (IADL), which encompass complex tasks necessary for independent living, are a particularly important component of post-ICU functional outcome. To conduct a systematic review of studies evaluating IADLs in survivors of critical illness. We searched PubMed, CINAHL, Cochrane Library, SCOPUS, and Web of Science for all relevant English-language studies published through December 31, 2016. Additional articles were identified from personal files and reference lists of eligible studies. Two trained researchers independently reviewed titles and abstracts, and potentially eligible full text studies. Eligible studies included those enrolling adult ICU survivors with IADL assessments, using a validated instrument. We excluded studies involving specific ICU patient populations, specialty ICUs, those enrolling fewer than 10 patients, and those that were not peer-reviewed. Variables related to IADLs were reported using the Patient Reported Outcomes Measurement Information System (PROMIS). Thirty of 991 articles from our literature search met inclusion criteria, and 23 additional articles were identified from review of reference lists and personal files. Sixteen studies (30%) published between 1999 and 2016 met eligibility criteria and were included in the review. Study definitions of impairment in IADLs were highly variable, as were reported rates of pre-ICU IADL dependencies (7-85% of patients). Eleven studies (69%) found that survivors of critical illness had new or worsening IADL dependencies. In three of four longitudinal studies, survivors with IADL dependencies decreased over the follow-up period. Across multiple studies, no risk factors were consistently associated with IADL dependency. Survivors of critical illness commonly experience new or worsening IADL dependency that may improve over time. As part of ongoing efforts to understand and improve functional status in ICU survivors, future research must focus on risk factors for IADL dependencies and interventions to improve these cognitive and physical dependencies after critical illness.

Mature Results of the Ottawa Phase II Study of Intermittent Androgen-Suppression Therapy in Prostate Cancer: Clinical Predictors of Outcome

DOE Office of Scientific and Technical Information (OSTI.GOV)

Malone, Shawn; Perry, Gad; Eapen, Libni

2007-07-01

Purpose: To present the mature experience of a phase II trial of intermittent androgen suppression (IAS). Methods and Materials: Intermittent androgen-suppression therapy was initiated in prostate-cancer patients to delay hormone resistance and minimize potential side effects of androgen-deprivation therapy (ADT). Patients received cyclical periods of ADT and observation (off-treatment interval [OTI]). Androgen-deprivation therapy was reinitiated when the level of prostate-specific antigen (PSA) rose above 10 ng/ml, or for disease progression. Associations between clinical factors and eligibility for OTI were measured. Kaplan-Meier and Cox regression analyses were used to determine factors predicting the duration of OTIs. Results: Ninety-five patients completed 187more » cycles of treatment. The median duration of OTIs was 8.5 months. Patients with higher PSA and metastatic disease were less likely to be eligible for the first OTI (p < 0.01). In multivariate analysis, patients with higher PSA and local relapse had significantly longer OTIs (p < 0.01) compared with metastatic patients. The median time to withdrawal from the study was 37 months. Conclusions: Intermittent androgen suppression appears to be a favorable treatment option for patients with biochemically (according to level of PSA) or locally recurrent prostate cancer with favorable long-term survival, a high probability of eligibility for OTIs, and durable OTIs.« less

Interpreting survival data from clinical trials of surgery versus stereotactic body radiation therapy in operable Stage I non-small cell lung cancer patients.

PubMed

Samson, Pamela; Keogan, Kathleen; Crabtree, Traves; Colditz, Graham; Broderick, Stephen; Puri, Varun; Meyers, Bryan

2017-01-01

To identify the variability of short- and long-term survival outcomes among closed Phase III randomized controlled trials with small sample sizes comparing SBRT (stereotactic body radiation therapy) and surgical resection in operable clinical Stage I non-small cell lung cancer (NSCLC) patients. Clinical Stage I NSCLC patients who underwent surgery at our institution meeting the inclusion/exclusion criteria for STARS (Randomized Study to Compare CyberKnife to Surgical Resection in Stage I Non-small Cell Lung Cancer), ROSEL (Trial of Either Surgery or Stereotactic Radiotherapy for Early Stage (IA) Lung Cancer), or both were identified. Bootstrapping analysis provided 10,000 iterations to depict 30-day mortality and three-year overall survival (OS) in cohorts of 16 patients (to simulate the STARS surgical arm), 27 patients (to simulate the pooled surgical arms of STARS and ROSEL), and 515 (to simulate the goal accrual for the surgical arm of STARS). From 2000 to 2012, 749/873 (86%) of clinical Stage I NSCLC patients who underwent resection were eligible for STARS only, ROSEL only, or both studies. When patients eligible for STARS only were repeatedly sampled with a cohort size of 16, the 3-year OS rates ranged from 27 to 100%, and 30-day mortality varied from 0 to 25%. When patients eligible for ROSEL or for both STARS and ROSEL underwent bootstrapping with n=27, the 3-year OS ranged from 46 to 100%, while 30-day mortality varied from 0 to 15%. Finally, when patients eligible for STARS were repeatedly sampled in groups of 515, 3-year OS narrowed to 70-85%, with 30-day mortality varying from 0 to 4%. Short- and long-term survival outcomes from trials with small sample sizes are extremely variable and unreliable for extrapolation. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Potential Health Implications of Medication Therapy Management Eligibility Criteria in the Patient Protection and Affordable Care Act Across Racial and Ethnic Groups.

PubMed

Wang, Junling; Qiao, Yanru; Shih, Ya-Chen Tina; Jarrett-Jamison, JoEllen; Spivey, Christina A; Wan, Jim Y; White-Means, Shelley I; Dagogo-Jack, Samuel; Cushman, William C; Chisholm-Burns, Marie

2015-11-01

The Medicare Prescription Drug, Improvement, and Modernization Act requires Part D plans to establish programs to provide medication therapy management (MTM) services starting from 2006. MTM services have been found to improve patient outcomes from pharmacotherapy, reduce emergency room visits and hospitalizations, and reduce health care costs in a cost-effective fashion. However, previous research found that non-Hispanic blacks (blacks) and Hispanics may be less likely to be eligible for MTM services than non-Hispanic whites (whites) among the Medicare population, according to current Medicare MTM eligibility criteria. This finding is because Medicare MTM eligibility criteria are predominantly based on medication use and costs, and blacks and Hispanics tend to use fewer prescription medications and incur lower prescription medication costs. The Patient Protection and Affordable Care Act (PPACA) laid out a set of MTM eligibility criteria for eligible entities to target patients for MTM services: "(1) take 4 or more prescribed medications ...; (2) take any 'high risk' medications; (3) have 2 or more chronic diseases ... or (4) have undergone a transition of care, or other factors ... that are likely to create a high risk of medication-related problems." To (a) examine racial/ethnic disparities in meeting the eligibility criteria for MTM services in PPACA among the Medicare population and (b) determine whether there would be greater disparities in health and economic outcomes among MTM-ineligible than MTM-eligible groups. This was a retrospective cross-sectional analysis of the Medicare Current Beneficiaries Survey (2007-2008). To determine medication characteristics, the U.S. Food and Drug Administration's Electronic Orange Book was also used. Proportions of the population eligible for MTM services based on PPACA MTM eligibility criteria were compared across racial and ethnic groups using a chi-square test; a logistic regression model was used to adjust for population sociodemographic and health characteristics. Health and economic outcomes examined included health status (self-perceived good health status, number of chronic diseases, activities of daily living [ADLs], and instrumental activities of daily living [IADLs]), health services utilization and costs (physician visits, emergency room visits, and total health care costs), and medication use patterns (generic dispensing ratio). To determine difference in disparities across MTM eligibility categories, difference-in-differences regressions of various functional forms were employed, depending on the nature of the dependent variables. Interaction terms between the dummy variables for minority groups (e.g., blacks or Hispanics) and MTM eligibility were included to test whether disparity patterns varied between MTM-ineligible and MTM-eligible individuals. The sample consisted of 12,966 Medicare beneficiaries, of which 11,161 were white, 930 were black, and 875 were Hispanic. Of the study sample, 9,992 whites (86.4%), 825 blacks (86.3%), and 733 Hispanics (80.6%) were eligible for MTM. The difference between whites and Hispanics was significant (P  less than  0.050), and the difference between whites and blacks was not significant (P  greater than 0.050). In multivariate analyses, significant disparity in eligibility for MTM services was found only between Hispanics and whites (odds ratio [OR] = 0.59; 95% CI = 0.43-0.82) but not between blacks and whites (OR = 0.78; 95% CI = 0.55-1.09). Disparities were greater among the MTM-ineligible than the MTM-eligible populations in self-perceived health status, ADLs, and IADLs for both blacks and Hispanics compared with whites. When analyzing the number of chronic conditions, the number and costs of physician visits, and total health care costs, the authors of this study found lower racial and ethnic disparities among the ineligible population than the eligible population. Hispanics are significantly less likely than whites to qualify for MTM among the Medicare population, according to MTM eligibility criteria stipulated in the PPACA. PPACA MTM eligibility criteria may aggravate existing racial and ethnic disparities in health status but may remediate racial and ethnic disparities in health services utilization. Alternative MTM eligibility criteria other than PPACA MTM eligibility criteria may be needed to improve the efficiency and equity of access to Medicare Part D MTM programs.

Medical Utilization of Kiosks in the Delivery of Patient Education: A Systematic Review

PubMed Central

Yvonne Chan, Yu-Feng; Nagurka, Roxanne; Bentley, Suzanne; Ordonez, Edgardo; Sproule, William

2014-01-01

Background: The utilization of kiosks has previously been shown to be effective for collecting information, delivering educational modules, and providing access to health information. We discuss a review of current literature for the utilization of kiosks for the delivery of patient education. Methods: The criteria for inclusion in this literature review were: (1) study discusses the utilization of kiosks for patient health education; (2) study discusses the use of touch screens for patient health information; (3) published in English. Our review includes searches via MEDLINE databases and Google Scholar for the years 1996-2014. Results: Overall, 167 articles were screened for final eligibility, and after discarding duplicates and non-eligible studies with abstract. Full-text review of 28 articles was included in the final analysis. Conclusion: The review of available literature demonstrates the effectiveness of touch screen kiosks to educate patients and to improve healthcare, both at a performance and cost advantage over other modes of patient education. PMID:25097831

Evaluation of the Rectal Cancer Patient Decision Aid: A Before and After Study.

PubMed

Wu, Robert Chi; Boushey, Robin Paul; Scheer, Adena Sarah; Potter, Beth; Moloo, Husein; Auer, Rebecca; Tadros, Shaheer; Roberts, Patricia; Stacey, Dawn

2016-03-01

In rectal cancer surgery, low anterior resection and abdominoperineal resection have equivocal impact on overall quality of life. A rectal cancer decision aid was developed to help patients weigh features of options and share their preference. The aim of this study was to evaluate the effect of a patient decision aid for mid to low rectal cancer surgery on the patients' choice and decision-making process. A before-and-after study was conducted. Baseline data collection occurred after surgeon confirmation of eligibility at the first consultation. Patients used the patient decision aid at home (online and/or paper-based formats) and completed post questionnaires. This study was conducted at an academic hospital referral center. Adults who had rectal cancer at a maximum of 10 cm proximal to the anal verge and were amenable to surgical resection were considered. Those with preexisting stoma and those only receiving abdominoperineal resection for technical reasons were excluded from the study. Patient with rectal cancer were provided with a decision aid. The primary outcomes measured were decisional conflict, knowledge, and preference for a surgical option. Of 136 patients newly diagnosed with rectal cancer over 13 months, 44 (32.4%) were eligible, 36 (81.9%) of the eligible patients consented to participate, and 32 (88.9%) patients completed the study. The mean age of participants was 61.9 ± 9.7 years and tumor location was on average 7.3 ± 2.1 cm above the anal verge. Patients had poor baseline knowledge (52.5%), and their knowledge improved by 37.5% (p < 0.0001) after they used the patient decision aid. Decisional conflict was reduced by 24.2% (p = 0.0001). At baseline, no patients preferred a permanent stoma, and after decision aid exposure, 2 patients (7.1%) preferred permanent stoma. Over 96% of participants would recommend the patient decision aid to others. This study was limited by the lack of control for potential confounders and potential response bias. The patient decision aid reduced decisional conflict and improved patient knowledge. Participants would recommend it to other patients with rectal cancer.

Management of haemothoraces in blunt thoracic trauma: study protocol for a randomised controlled trial.

PubMed

Carver, David A; Bressan, Alexsander K; Schieman, Colin; Grondin, Sean C; Kirkpatrick, Andrew W; Lall, Rohan; McBeth, Paul B; Dunham, Michael B; Ball, Chad G

2018-03-03

Haemothorax following blunt thoracic trauma is a common source of morbidity and mortality. The optimal management of moderate to large haemothoraces has yet to be defined. Observational data have suggested that expectant management may be an appropriate strategy in stable patients. This study aims to compare the outcomes of patients with haemothoraces following blunt thoracic trauma treated with either chest drainage or expectant management. This is a single-centre, dual-arm randomised controlled trial. Patients presenting with a moderate to large sized haemothorax following blunt thoracic trauma will be assessed for eligibility. Eligible patients will then undergo an informed consent process followed by randomisation to either (1) chest drainage (tube thoracostomy) or (2) expectant management. These groups will be compared for the rate of additional thoracic interventions, major thoracic complications, length of stay and mortality. This study has been approved by the institution's research ethics board and registered with ClinicalTrials.gov. All eligible participants will provide informed consent prior to randomisation. The results of this study may provide guidance in an area where there remains significant variation between clinicians. The results of this study will be published in peer-reviewed journals and presented at national and international conferences. NCT03050502. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A novel use of the Spine Tango registry to evaluate selection bias in patient recruitment into clinical studies: an analysis of patients participating in the Lumbar Spinal Stenosis Outcome Study (LSOS).

PubMed

Becker, H-J; Nauer, S; Porchet, F; Kleinstück, F S; Haschtmann, D; Fekete, T F; Steurer, J; Mannion, A F

2017-02-01

Patients enrolled in clinical studies typically represent a sub-set of all who are eligible, and selection bias may compromise the generalizability of the findings. Using Registry data, we evaluated whether surgical patients recruited by one of the referring centres into the Lumbar Spinal Stenosis Outcome Study (LSOS; a large-scale, multicentre prospective observational study to determine the probability of clinical benefit after surgery) differed in any significant way from those who were eligible but not enrolled. Data were extracted for all patients with lumbar spinal stenosis registered in our in-house database (interfaced to Eurospine's Spine Tango Registry) from 2011 to 2013. Patient records and imaging were evaluated in relation to the admission criteria for LSOS to identify those who would have been eligible for participation but were not enrolled (non-LSOS). The Tango surgery data and Core Outcome Measures Index (COMI) data at baseline and 3 and 12 months after surgery were analysed to evaluate the factors associated with LSOS enrolment or not. 514 potentially eligible patients were identified, of which 94 (18%) were enrolled into LSOS (range 2-48% for the 6 spine surgeons involved in recruiting patients) and 420 (82%) were not; the vast majority of the latter were due to non-referral to the study by the surgeon, with only 5% actually refusing participation. There was no significant difference in gender, age, BMI, smoking status, or ASA score between the two groups (p ≥ 0.18). Baseline COMI was significantly (p = 0.002) worse in the non-LSOS group (7.4 ± 1.9) than the LSOS group (6.7 ± 1.9). There were no significant group differences in any Tango surgery parameters (additional spine patholothegies, operation time, blood loss, complications, etc.) although significantly more patients in the non-LSOS group had a fusion procedure (38 vs 18% in LSOS; p = 0.0004). Postoperatively, neither the COMI nor its subdomain scores differed significantly between the groups (p > 0.05). Multiple logistic regression revealed that worse baseline COMI (p = 0.021), surgeon (p = 0.003), and having fusion (p = 0.014) predicted non-enrolment in LSOS. A high proportion of eligible patients were not enrolled in the study. Non-enrolment was explained in part by the specific surgeon, worse baseline COMI status, and having a fusion. The findings may reflect a tendency of the referring surgeon not to overburden more disabled patients and those undergoing more extensive surgery with the commitments of a study. Beyond these factors, non-enrolment appeared to be somewhat arbitrary, and was likely related to surgeon forgetfulness, time constraints, and administrative errors. Researchers should be aware of potential selection bias in their clinical studies, measure it (where possible) and discuss its implications for the interpretation of the study's findings.

Potential adult Medicaid beneficiaries under the Patient Protection and Affordable Care Act compared with current adult Medicaid beneficiaries.

PubMed

Chang, Tammy; Davis, Matthew

2013-01-01

Under health care reform, states will have the opportunity to expand Medicaid to millions of uninsured US adults. Information regarding this population is vital to physicians as they prepare for more patients with coverage. Our objective was to describe demographic and health characteristics of potentially eligible Medicaid beneficiaries. We performed a cross-sectional study using data from the National Health and Nutrition Examination Survey (2007-2010) to identify and compare adult US citizens potentially eligible for Medicaid under provisions of the Patient Protection and Affordable Care Act (ACA) with current adult Medicaid beneficiaries. We compared demographic characteristics (age, sex, race/ethnicity, education) and health measures (self-reported health status; measured body mass index, hemoglobin A1c level, systolic and diastolic blood pressure, depression screen [9-item Patient Health Questionnaire], tobacco smoking, and alcohol use). Analyses were based on an estimated 13.8 million current adult non-elderly Medicaid beneficiaries and 13.6 million nonelderly adults potentially eligible for Medicaid. Potentially eligible individuals are expected to be more likely male (49.2% potentially eligible vs 33.3% current beneficiaries; P <.001), to be more likely white and less likely black (58.8% white, 20.0% black vs 49.9% white, 25.2% black; P = .02), and to be statistically indistinguishable in terms of educational attainment. Overall, potentially eligible adults are expected to have better health status (34.8% "excellent" or "very good," 40.4% "good") than current beneficiaries (33.5% "excellent" or "very good," 31.6% "good"; P <.001). The proportions obese (34.5% vs 42.9%; P = .008) and with depression (15.5% vs 22.3%; P = .003) among potentially eligible individuals are significantly lower than those for current beneficiaries, while there are no significant differences in the expected prevalence of diabetes or hypertension. Current tobacco smoking (49.2% vs 38.0%; P = .002), and moderate and heavier alcohol use (21.6% vs 16.0% and 16.5% vs 9.8%; P <.001, respectively) are more common among the potentially eligible population than among current beneficiaries. Under the ACA, physicians can anticipate a potentially eligible Medicaid population with equal if not better current health status and lower prevalence of obesity and depression than current Medicaid beneficiaries. Federal Medicaid expenditures for newly covered beneficiaries therefore may not be as high as anticipated in the short term. Given the higher prevalence of tobacco smoking and alcohol use, however, broad enrollment and engagement of this potentially eligible population is needed to address their higher prevalence of modifiable risk factors for future chronic disease.

What Is Different About Worker’s Compensation Patients?

PubMed Central

Atlas, Steven J.; Tosteson, Tor D.; Hanscom, Brett; Blood, Emily A.; Pransky, Glenn S.; Abdu, William A.; Andersson, Gunnar B.; Weinstein, James N.

2010-01-01

Study Design Combined analysis of 2 prospective clinical studies. Objective To identify socioeconomic characteristics associated with workers’ compensation in patients with an intervertebral disc herniation (IDH) or spinal stenosis (SpS). Summary of Background Data Few studies have compared socioeconomic differences between those receiving or not receiving workers’ compensation with the same underlying clinical conditions. Methods Patients were identified from the Spine Patient Outcomes Research Trial (SPORT) and the National Spine Network (NSN) practice-based outcomes study. Patients with IDH and SpS within NSN were identified satisfying SPORT eligibility criteria. Information on disability and work status at baseline evaluation was used to categorize patients into 3 groups: workers’ compensation, other disability compensation, or work-eligible controls. Enrollment rates of patients with disability in a clinical efficacy trial (SPORT) and practice-based network (NSN) were compared. Independent socioeconomic predictors of baseline workers’ compensation status were identified in multivariate logistic regression models controlling for clinical condition, study cohort, and initial treatment designation. Results Among 3759 eligible patients (1480 in SPORT and 2279 in NSN), 564 (15%) were receiving workers’ compensation, 317 (8%) were receiving other disability compensation, and 2878 (77%) were controls. Patients receiving workers’ compensation were less common in SPORT than NSN (9.2% vs. 18.8%, P < 0.001), but patients receiving other disability compensation were similarly represented (8.9% vs. 7.7%, P = 0.19). In univariate analyses, many socioeconomic characteristics significantly differed according to baseline workers’ compensation status. In multiple logistic regression analyses, gender, educational level, work characteristics, legal action, and expectations about ability to work without surgery were independently associated with receiving workers’ compensation. Conclusion Clinical trials involving conditions commonly seen in patients with workers’ compensation may need special efforts to ensure adequate representation. Socioeconomic characteristics markedly differed between patients receiving and not receiving workers’ compensation. Identifying the independent effects of workers’ compensation on outcomes will require controlling for these baseline characteristics and other clinical features associated with disability status. PMID:17700451

Discrete event simulation of patient admissions to a neurovascular unit.

PubMed

Hahn-Goldberg, S; Chow, E; Appel, E; Ko, F T F; Tan, P; Gavin, M B; Ng, T; Abrams, H B; Casaubon, L K; Carter, M W

2014-01-01

Evidence exists that clinical outcomes improve for stroke patients admitted to specialized Stroke Units. The Toronto Western Hospital created a Neurovascular Unit (NVU) using beds from general internal medicine, Neurology and Neurosurgery to care for patients with stroke and acute neurovascular conditions. Using patient-level data for NVU-eligible patients, a discrete event simulation was created to study changes in patient flow and length of stay pre- and post-NVU implementation. Varying patient volumes and resources were tested to determine the ideal number of beds under various conditions. In the first year of operation, the NVU admitted 507 patients, over 66% of NVU-eligible patient volumes. With the introduction of the NVU, length of stay decreased by around 8%. Scenario testing showed that the current level of 20 beds is sufficient for accommodating the current demand and would continue to be sufficient with an increase in demand of up to 20%.

Evaluation of Statin Eligibility, Prescribing Practices, and Therapeutic Responses Using ATP III, ACC/AHA, and NLA Dyslipidemia Treatment Guidelines in a Large Urban Cohort of HIV-Infected Outpatients.

PubMed

Levy, Matthew E; Greenberg, Alan E; Magnus, Manya; Younes, Naji; Castel, Amanda

2018-02-01

Statin coverage has been examined among HIV-infected patients using Adult Treatment Panel III (ATP III) and American College of Cardiology/American Heart Association (ACC/AHA) guidelines, although not with newer National Lipid Association (NLA) guidelines. We investigated statin eligibility, prescribing practices, and therapeutic responses using these three guidelines. Sociodemographic, clinical, and laboratory data were collected between 2011 and 2016 for HIV-infected outpatients enrolled in the DC Cohort, a multi-center, prospective, observational study in Washington, DC. This analysis included patients aged ≥21 years receiving primary care at their HIV clinic site with ≥1 cholesterol result available. Of 3312 patients (median age 52; 79% black), 52% were eligible for statins based on ≥1 guideline, including 45% (NLA), 40% (ACC/AHA), and 30% (ATP III). Using each guideline, 49% (NLA), 56% (ACC/AHA), and 73% (ATP III) of eligible patients were prescribed statins. Predictors of new prescriptions included older age (aHR = 1.16 [1.08-1.26]/5 years), body mass index ≥30 (aHR = 1.50 [1.07-2.11]), and diabetes (aHR = 1.35 [1.03-1.79]). Hepatitis C coinfection was inversely associated with statin prescriptions (aHR = 0.67 [0.45-1.00]). Among 216 patients with available cholesterol results pre-/post-prescription, 53% achieved their NLA cholesterol goal after 6 months. Hepatitis C coinfection was positively associated (aHR = 1.87 [1.06-3.32]), and depression (aHR = 0.56 [0.35-0.92]) and protease inhibitor use (aHR = 0.61 [0.40-0.93]) were inversely associated, with NLA goal achievement. Half of patients were eligible for statins based on current US guidelines, with the highest proportion eligible based on NLA guidelines, yet, fewer received prescriptions and achieved treatment goals. Greater compliance with recommended statin prescribing practices may reduce cardiovascular disease risk among HIV-infected individuals.

The effect of Saccharomyces boulardii in patients eligible for liver transplantation.

PubMed

Liboredo, Juliana Costa; Ferrari, Maria de Lourdes Abreu; Vilela, Eduardo Garcia; Lima, Agnaldo Soares; Correia, Maria Isabel Toulson Davisson

2014-09-12

The aim of this study was to evaluate the influence of Saccharomyces boulardii on the intestinal permeability, laboratory parameters and MELD and Child-Pugh severity scores in cirrhotic patients eligible for liver transplantation. Eighteen patients followed in a Transplant Outpatient Clinic were evaluated immediately before the beginning of treatment, after a 30-day period of treatment period with probiotics and at the end of the second study month (after a thirty-day period without probiotics). Fifteen healthy controls also underwent the intestinal permeability test (lactulose/mannitol). Before the probiotic, the median lactulose/ mannitol ratio was greater in the cirrhotic patients (0.0209, range 0.0012-0.1984) compared to the healthy controls (0.0030, range 0.0020-0.0013) (p < 0.05). Eight of fifteen patients, half of whom had ascites, showed increased intestinal permeability above the higher value observed in the controls. No significant association was found between the severity scores for liver disease, age, presence of ascites and intestinal permeability immediately before the beginning of study. After treatment with S. boulardii, there was no improvement in intestinal permeability or significant differences in the laboratory parameters for the three evaluations. Patients eligible for liver transplants presented with increased intestinal permeability compared to healthy controls. A thirty-day treatment with S. boulardii did not improve this intestinal permeability or the severity scores, nor did it impact the laboratory parameters. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Geographic distribution of point-in-time access to subsidised dental services in Western Australia.

PubMed

Dudko, Yevgeni; Kruger, Estie; Tennant, Marc

2016-02-01

Dental Health Services (DHS) is the largest public primary oral healthcare provider in WA. The objective of this study was to calculate probable distance patients are expected to travel to the nearest clinic, gauge utilisation rates and predict the direction of likely changes in future demand for subsidised dental care. Eligible population data was collected from the Department of Human Services and the Australian Bureau of Statistics websites and integrated with the waiting list and the recall list data provided by the DHS. In total, 65% of the eligible WA population are residing in the metropolitan area; however, only 19% of those are either on the waiting list or have already received subsidised care. In all, 35% of the total eligible WA population are residing in country areas. A total of 30% of the eligible country WA patients are located within a 100-km range of a Government Dental Clinic, with only 11% of those either on the waiting list or having already received subsidised dental care. Country WA residents are at a significant disadvantage by comparison to their metropolitan counterparts. Eligible WA country residents are up to 40% less likely to receive treatment when compared to the metropolitan residents.

Real world cost of human epidermal receptor 2-positive metastatic breast cancer patients: a longitudinal incidence-based observational costing study in the Netherlands and Belgium.

PubMed

Frederix, G W J; Severens, J L; Hövels, A M; van Hasselt, J G C; Hooiveld, M J J; Neven, P; Raaijmakers, J A M; Schellens, J H M

2015-05-01

Currently, no country-specific metastatic breast cancer (MBC) observational costing data are available for the Netherlands and Belgium. Our aim is to describe country-specific resource use and costs of human epidermal receptor 2 (HER-2)-positive MBC in the Netherlands and Belgium, making use of real-world data. The eligibility period for patient selection was from April 2004 to April 2010. Inclusion and retrospective data collection begins at the time of first diagnosis of HER-2-positive MBC during the eligibility period and ends 24 months post-index diagnosis of MBC or at patient death. We identified 88 eligible patients in the Netherlands and 44 patients in Belgium. The total costs of medical treatment and other resource use utilisation per patient was €48,301 in the Netherlands and €37,431 in Belgium. Majority of costs was related to the use of trastuzumab in both countries, which was 50% of the total costs in the Netherlands and 56% in Belgium respectively. Our study provides estimates of resource use and costs for HER-2-positive MBC in the Netherlands and Belgium. We noticed various differences in resource use patterns between both countries demonstrating caution is needed when transferring cost estimates between countries. © 2014 John Wiley & Sons Ltd.

Evaluation of pneumococcal vaccination rates after vaccine protocol changes and nurse education in a tertiary care teaching hospital.

PubMed

Smith, Jennifer G; Metzger, Nicole L

2011-11-01

Pneumococcal vaccination in eligible patients is recommended by the Infectious Disease Society of America and the Centers for Disease Control (CDC) Advisory Committee on Immunization Practices. Because hospitalization provides an opportunity to vaccinate patients at high risk for developing serious pneumonia complications, eligibility screening and administration of the pneumococcal vaccine prior to discharge in qualified patients are evaluated by the Joint Commission and the Centers for Medicare Medicaid Services (CMS) as part of pneumococcal vaccination core quality measures. Among patients with an inpatient diagnosis of pneumonia in 2008, 56% in our 580-bed tertiary care teaching hospital, compared with 84% nationwide, received pneumococcal vaccination. To improve pneumococcal vaccination rates for all patients in the study facility and not just those with pneumonia, a multifaceted intervention including a revised nurse screening tool, rescheduling of the vaccine order, storage of the vaccine in automated dispensing cabinets on the nursing unit, and creation of a vaccine tracking system was developed and implemented between August 2009 and October 2009. To determine the impact of a multifaceted intervention on pneumococcal vaccine screening and administration rates in eligible patients according to the CDC recommendations who were admitted to an internal medicine unit of a tertiary care teaching hospital. All patients aged 18 years or older from 2 internal medicine units were identified during 4-month time intervals before (pre-intervention, April through July 2009) and after (post-intervention, November 2009 through February 2010) implementation of the multifaceted pneumococcal vaccine protocol. Of these, 150 patients from each 4-month period were randomly selected for electronic medical record review. Eligibility for pneumococcal vaccination was derived from the CDC recommendations and consensus of the vaccine steering committee at the study institution; the criteria included aged 65 years or older, admitting diagnosis of pneumonia, at least 1 of several chronic diseases, immunocompromising condition, cochlear implant, cerebrospinal fluid leak, current tobacco smoking, pregnancy or having a child in the home less than aged 6 months, or awaiting solid organ transplantation. Patients who had vaccine contraindications/precautions or had been vaccinated in the previous 5 years were ineligible. Data on demographics, presence of vaccine screening, indication, administration, rescheduling, and refusal were collected. The primary endpoint was the rate of pneumococcal vaccine administration in eligible medicine patients. Secondary endpoints included changes in screening rates, vaccine refusal, and order rescheduling. Descriptive statistics and Student's t-test were used to evaluate patient demographic data. Pearson chi-square was used to compare the pre- and post-implementation periods. The rate of pneumococcal vaccine administration in eligible patients significantly improved post-implementation compared with pre-implementation (74.2% vs. 19.1%, respectively, P < 0.001). Rates of vaccine screening were similar pre-implementation (96.0%) and post-implementation (99.3%, P = 0.056). The rates of vaccine refusal in the pre- and post-implementation periods did not significantly differ (10.6% vs. 22.6%, respectively, P = 0.203). Implementation of vaccine protocol changes was associated with improved pneumococcal vaccination rates in eligible medicine patients. Protocol changes were relatively easy to implement in a large institution, and a similar approach may be implemented at other institutions as an effective way to improve pneumococcal vaccination rates.

What is different about workers' compensation patients? Socioeconomic predictors of baseline disability status among patients with lumbar radiculopathy.

PubMed

Atlas, Steven J; Tosteson, Tor D; Hanscom, Brett; Blood, Emily A; Pransky, Glenn S; Abdu, William A; Andersson, Gunnar B; Weinstein, James N

2007-08-15

Combined analysis of 2 prospective clinical studies. To identify socioeconomic characteristics associated with workers' compensation in patients with an intervertebral disc herniation (IDH) or spinal stenosis (SpS). Few studies have compared socioeconomic differences between those receiving or not receiving workers' compensation with the same underlying clinical conditions. Patients were identified from the Spine Patient Outcomes Research Trial (SPORT) and the National Spine Network (NSN) practice-based outcomes study. Patients with IDH and SpS within NSN were identified satisfying SPORT eligibility criteria. Information on disability and work status at baseline evaluation was used to categorize patients into 3 groups: workers' compensation, other disability compensation, or work-eligible controls. Enrollment rates of patients with disability in a clinical efficacy trial (SPORT) and practice-based network (NSN) were compared. Independent socioeconomic predictors of baseline workers' compensation status were identified in multivariate logistic regression models controlling for clinical condition, study cohort, and initial treatment designation. Among 3759 eligible patients (1480 in SPORT and 2279 in NSN), 564 (15%) were receiving workers' compensation, 317 (8%) were receiving other disability compensation, and 2878 (77%) were controls. Patients receiving workers' compensation were less common in SPORT than NSN (9.2% vs. 18.8%, P < 0.001), but patients receiving other disability compensation were similarly represented (8.9% vs. 7.7%, P = 0.19). In univariate analyses, many socioeconomic characteristics significantly differed according to baseline workers' compensation status. In multiple logistic regression analyses, gender, educational level, work characteristics, legal action, and expectations about ability to work without surgery were independently associated with receiving workers' compensation. Clinical trials involving conditions commonly seen in patients with workers' compensation may need special efforts to ensure adequate representation. Socioeconomic characteristics markedly differed between patients receiving and not receiving workers' compensation. Identifying the independent effects of workers' compensation on outcomes will require controlling for these baseline characteristics and other clinical features associated with disability status.

Assessing factors for loss to follow-up of HIV infected patients in Guinea-Bissau.

PubMed

Nordentoft, Pernille Bejer; Engell-Sørensen, Thomas; Jespersen, Sanne; Correia, Faustino Gomes; Medina, Candida; da Silva Té, David; Østergaard, Lars; Laursen, Alex Lund; Wejse, Christian; Hønge, Bo Langhoff

2017-04-01

The objective of this study was to ascertain vital status of patients considered lost to follow-up at an HIV clinic in Guinea-Bissau, and describe reasons for loss to follow-up (LTFU). This study was a cross-sectional sample of a prospective cohort, carried out between May 15, 2013, and January 31, 2014. Patients lost to follow-up, who lived within the area of the Bandim Health Project, a demographic surveillance site (DSS), were eligible for inclusion. Active follow-up was attempted by telephone and tracing by a field assistant. Semi-structured interviews were done face to face or by phone by a field assistant and patients were asked why they had not shown up for the scheduled appointment. Patients were included by date of HIV testing and risk factors for LTFU were assessed using Cox proportional hazard model. Among 561 patients (69.5 % HIV-1, 18.0 % HIV-2 and 12.6 % HIV-1/2) living within the DSS, 292 patients had been lost to follow-up and were, therefore, eligible for active follow-up. Vital status was ascertained in 65.9 % of eligible patients and 42.7 % were alive, while 23.2 % had died. Information on reasons for LTFU existed for 103 patients. Major reasons were moving (29.1 %), travelling (17.5 %), and transferring to other clinics (11.7 %). A large proportion of the patients at the clinic were lost to follow-up. The main reason for this was found to be the geographic mobility of the population in Guinea-Bissau.

Why do GPs exclude patients from participating in research? An exploration of adherence to and divergence from trial criteria.

PubMed

Jenkinson, Caroline E; Winder, Rachel E; Sugg, Holly V R; Roberts, Martin J; Ridgway, Nicola; Kuyken, Willem; Wiles, Nicola; Kessler, David; Campbell, John

2014-06-01

The role of GPs in recruiting or excluding participants critically underpins the feasibility, external validity and generalizability of primary care research. A better understanding of this role is needed. To investigate why GPs excluded potentially eligible participants from a large scale randomized controlled trial (RCT), to determine the proportion of patients excluded on account of trial eligibility compared with other reasons, and to explore the impact of such exclusions on the management and generalizability of RCTs. Secondary analysis of data from the CoBalT study, a multi-centre general-practice-based RCT investigating cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression. GPs were asked to screen patient lists generated from computerized record searches for trial eligibility and to provide narrative reasons for excluding patients. These reasons were coded independently by two researchers, with a third researcher resolving discrepancies. Thirty-one percent (4750/15,379) of patients were excluded at the GP screening stage, including 663 on patient lists that remained unscreened. Of the 4087 actively excluded patients, 67% were excluded on account of trial exclusion criteria, 20% for other criteria (half of which were comorbid conditions) and 13% without reason. Clear, comprehensive criteria, particularly with regards to comorbidities, are required for GPs to confidently screen patients for potential participation in research. Future studies should promote inclusivity and encourage GPs to adopt a liberal approach when screening patient lists. This would enhance the validity and generalizability of primary care research and encourage greater patient autonomy. © Crown copyright 2014.

Impact of a Computerized Antithrombotic Risk Assessment Tool on the Prescription of Thromboprophylaxis in Atrial Fibrillation: Hospital Setting.

PubMed

Pandya, E; Masood, N; Wang, Y; Krass, I; Bajorek, B

2018-01-01

The computerized antithrombotic risk assessment tool (CARAT) is an online decision-support algorithm that facilitates a systematic review of a patient's stroke risk, bleeding risk, and pertinent medication safety considerations, to generate an individualized treatment recommendation. The CARAT was prospectively applied across 2 hospitals in the greater Sydney area. Its impact on antithrombotics utilization for thromboprophylaxis in patients with nonvalvular atrial fibrillation was evaluated. Factors influencing prescribers' treatment selection were identified. The CARAT recommended a change in baseline therapy for 51.8% of patients. Among anticoagulant-eligible patients (ie, where the risk of stroke outweighed the risk of bleeding) using "nil therapy" or antiplatelet therapy at baseline, the CARAT recommended an upgrade to warfarin in 60 (30.8%) patients. For those in whom the bleeding risk outweighed the stroke risk, the CARAT recommended a downgrade from warfarin to safer alternatives (eg, aspirin) in 37 (19%) patients. Among the "most eligible" (ie, high stroke risk, low bleeding risk, no contraindications; n = 75), the CARAT recommended warfarin for all cases. Discharge therapy observed a marginal increase in anticoagulation prescription in eligible patients (n = 116; 57.8% vs 64.7%, P = .35) compared to baseline. Predictors of warfarin use (vs antiplatelets) included congestive cardiac failure, diabetes mellitus, and polypharmacy. The CARAT was able to optimize the selection of therapy, increasing anticoagulant use among eligible patients. With the increasing complexity of decision-making, such tools may be useful adjuncts in therapy selection in atrial fibrillation. Future studies should explore the utility of such tools in selecting therapies from within an expanded treatment armamentarium comprising the non-vitamin K antagonist oral anticoagulants.

Eligibility of Metastatic Pancreatic Cancer Patients for First-Line Palliative Intent nab-Paclitaxel Plus Gemcitabine Versus FOLFIRINOX.

PubMed

Peixoto, Renata D; Ho, Maria; Renouf, Daniel J; Lim, Howard J; Gill, Sharlene; Ruan, Jenny Y; Cheung, Winson Y

2017-10-01

The PRODIGE and MPACT trials showed superiority of FOLFIRINOX and nab-paclitaxel plus gemcitabine (NG) over gemcitabine alone, respectively. However, both had strict inclusion criteria. We sought to determine the characteristics of patients with metastatic pancreatic cancer (MPC) which inform the appropriateness of first-line chemotherapy FOLFIRINOX and NG in routine practice. Patients with MPC who initiated palliative chemotherapy with gemcitabine from 2000 to 2011 at the British Columbia Cancer Agency were identified. Clinicopathologic variables and outcomes were retrospectively collected and compared among groups. Eligibility criteria for each regimen were in accordance with the respective pivotal phase III trials. A total of 473 patients were included: 25% of the patients were eligible for FOLFIRINOX versus 45% for NG. Main reasons for FOLFIRINOX ineligibility were Eastern Cooperative Oncology Group (ECOG) performance status (PS)≥2 (56.5%), age older than 75 years (19.0%), and bilirubin>1.5× upper limit of normal (18.6%), whereas those for NG ineligibility were bilirubin > upper limit of normal (24.5%), ECOG PS≥3 (14.6%), and cardiac dysfunction (13.8%). Univariate analyses revealed that FOLFIRINOX and NG-eligible patients had longer median overall survival than their respective ineligible group (8.6 vs. 4.7 mo, P<0.001; 6.7 vs. 4.9 mo, P=0.008, respectively). After accounting for ECOG PS in the multivariate model, however, eligibility for either FOLFIRINOX or NG no longer predicted for better overall survival. The majority of patients with MPC are not candidates to either NG or FOLFIRINOX due to restrictive eligibility requirements. Specific trials addressing the unmet needs of protocol ineligible patients are warranted.

What proportion of patients with chronic heart failure are eligible for sacubitril-valsartan?

PubMed

Pellicori, Pierpaolo; Urbinati, Alessia; Shah, Parin; MacNamara, Alexandra; Kazmi, Syed; Dierckx, Riet; Zhang, Jufen; Cleland, John G F; Clark, Andrew L

2017-06-01

The PARADIGM-HF trial showed that sacubitril-valsartan, an ARB-neprilysin inhibitor, is more effective than enalapril for some patients with heart failure (HF). It is uncertain what proportion of patients with HF would be eligible for sacubitril-valsartan in clinical practice. Between 2001 and 2014, 6131 patients consecutively referred to a community HF clinic with suspected HF were assessed. The criteria required to enter the randomized phase of PARADIGM-HF, including symptoms, NT-proBNP, and current treatment with or without target doses of ACE inhibitors or ARBs, were applied to identify the proportion of patients eligible for sacubitril-valsartan. Recognizing the diversity of clinical opinion and guideline recommendations concerning this issue, entry criteria were applied singly and in combination. Of 1396 patients with reduced left ventricular ejection fraction (≤40%, HFrEF) and contemporary measurement of NT-proBNP, 379 were on target doses of an ACE inhibitor or ARB at their initial visit and, of these, 172 (45%) fulfilled the key entry criteria for the PARADIGM-HF trial. Lack of symptoms (32%) and NT-proBNP <600 ng/L (49%) were common reasons for failure to fulfil criteria. A further 122 patients became eligible during follow-up (n = 294, 21%). However, if background medication and doses were ignored, then 701 (50%) were eligible initially and a further 137 became eligible during follow-up. Of patients with HFrEF referred to a clinic such as ours, only 21% fulfilled the PARADIGM-HF randomization criteria, on which the ESC Guidelines are based; this proportion rises to 60% if background medication is ignored. © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

Zero end-digit preference in recorded blood pressure and its impact on classification of patients for pharmacologic management in primary care — PREDICT-CVD–6

PubMed Central

Broad, Joanna; Wells, Sue; Marshall, Roger; Jackson, Rod

2007-01-01

Background Most blood pressure recordings end with a zero end-digit despite guidelines recommending measurement to the nearest 2 mmHg. The impact of rounding on management of cardiovascular disease (CVD) risk is unknown. Aim To document the use of rounding to zero end-digit and assess its potential impact on eligibility for pharmacologic management of CVD risk. Design of study Cross-sectional study. Setting A total of 23 676 patients having opportunistic CVD risk assessment in primary care practices in New Zealand. Method To simulate rounding in practice, for patients with systolic blood pressures recorded without a zero end-digit, a second blood pressure measure was generated by arithmetically rounding to the nearest zero end-digit. A 10-year Framingham CVD risk score was estimated using actual and rounded blood pressures. Eligibility for pharmacologic treatment was then determined using the Joint British Societies' JBS2 and the British Hypertension Society BHS–IV guidelines based on actual and rounded blood pressure values. Results Zero end-digits were recorded in 64% of systolic and 62% of diastolic blood pressures. When eligibility for drug treatment was based only on a Framingham 10-year CVD risk threshold of 20% or more, rounding misclassified one in 41 of all those patients subject to this error. Under the two guidelines which use different combinations of CVD risk and blood pressure thresholds, one in 19 would be misclassified under JBS2 and one in 12 under the BHS–IV guidelines mostly towards increased treatment. Conclusion Zero end-digit preference significantly increases a patient's likelihood of being classified as eligible for drug treatment. Guidelines that base treatment decisions primarily on absolute CVD risk are less susceptible to these errors. PMID:17976291

Income levels of bad-debt and free-care patients in Massachusetts hospitals.

PubMed

Weissman, J S; Dryfoos, P; London, K

1999-01-01

This study disputes the common notion that many hospitalized patients whose expenses are written off to bad debt are able to pay their bills. By matching 1996 state tax returns to more than 350,000 bad-debt and free-care claims at seven Massachusetts hospitals, we found that most patients involved had incomes below the federal poverty level and thus were presumably eligible for either public programs or hospital-based free care. This suggests that hospitals and public officials need to investigate further why low-income, uninsured patients are not receiving benefits for which they are eligible. Our results also suggest that measurements of indigent care levels in hospitals for purposes of research or regulation should include some portion of bad debt.

[Utilizing the Rorschach Test in the diagnosis of gender identity disorder and in the evaluation of eligibility for sex reassignment surgery].

PubMed

Affatati, Valeria; Grattagliano, Ignazio; Todarello, Orlando; Catanesi, Roberto

2012-01-01

Gender identity disorder (GID) is a mental disorder in which gender identity is incongruent with the anatomical sex, in the absence of any clear and defined genetic or biological alteration. The diagnosis of GID as well as the assessment of patient eligibility for sex reassignment surgery (SRS) are prerequisite to the legal recognition procedure. The aim of this study was to evaluate the usefulness of the Rorschach test in differential diagnosis determination and primarily in providing information on patient eligibility for SRS, in the framework of the clinical, therapeutic and forensic psychometric and psychodiagnostic assessment, and according to the World Professional Association for Transgender Health (WPATH) criteria. For this purpose we analysed the Rorschach test of 47 patients (33 GID and 14 GID NAS). Results show that GID NAS patients have greater difficulties in stress control and less adaptability, which could lead to disorganisation, impulsiveness, behavioural disorders, as well as higher levels of situational and chronic stress, with altered thought patterns and uncontrolled ideation, a higher frequency of thought disorders and disturbed relations, with lower quality and less adaptive interpersonal relationships, which are characterized by dependency and aggressive behaviours. This research shows that the Rorschach test cannot be used alone in the determination of the differential diagnosis between GID and GID NAS in the diagnosis and evaluation of patient eligibility for SRS, especially when comparing groups which do not shows significant differences in the prevalence of the main psychopathological disorders.

1 Patient acceptability and feasibility of HIV testing in emergency departments in the UK - a systematic review and meta-analysis.

PubMed

Lungu, Nicola

2017-12-01

NICE 2016 HIV testing guidelines now include the recommendation to offer HIV testing in Emergency Departments, in areas of high prevalence, 1 to everyone who is undergoing blood tests. 23% of England's local authorities are areas of high HIV prevalence (>2/1000) and are therefore eligible. 2 So far very few Emergency Departments have implemented routine HIV testing. This systematic review assesses evidence for two implementation considerations: patient acceptability (how likely a patient will accept an HIV test when offered in an Emergency Department), and feasibility, which incorporates staff training and willingness, and department capacity, (how likely Emergency Department staff will offer an HIV test to an eligible patient), both measured by surrogate quantitative markers. Three medical databases were systematically searched for reports of non-targeted HIV testing in UK Emergency Departments. A total of 1584 unique papers were found, 9 full text articles were critically appraised, and 7 studies included in meta-analysis. There is a combined patient sample of 1 01 975. The primary outcome, patient acceptability of HIV testing in Emergency Departments (number of patients accepting an HIV test, as a proportion of those offered) is 54.1% (CI 40.1, 68.2). Feasibility (number of tests offered, as a proportion of eligible patients) is 36.2% (CI 9.8, 62.4). For an Emergency Department considering introducing routine HIV testing, this review suggests an opt-out publicity-lead strategy. Utilising oral fluid and blood tests would lead to the greatest proportion of eligible patients accepting an HIV test. For individual staff who are consenting patients for HIV testing, it may be encouraging to know that there is >50% chance the patient will accept an offer of testing.emermed;34/12/A860-a/T1F1T1Table 1Summary table of data extracted from final 7 studies, with calculated acceptability and feasibility if appropriate, and GRADE score. Studies listed in chronological order of data collection. GRADE working group evidence grades: 4= high quality, 3= moderate quality, 2= low quality, 1 or below = very low quality. (*study conclusion reports this figure is inaccurate)emermed;34/12/A860-a/F1F2F1Figure 1Patients accepting HIV tests, and being offered HIV tests, as a proportion of the eligible sample REFERENCES: National Institute for Health and Care Excellence, Public Health England. HIV testing: Increasing uptake among people who may have undiagnosed HIV . 2016 1 December 2016.Public Health England. HIV prevalence by Local Authority of residence to end December 2015 . Table No.1: 2016. Public Health Engand; 2016. © 2017, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Early Adoption of Sacubitril/Valsartan for Patients With Heart Failure With Reduced Ejection Fraction: Insights From Get With the Guidelines-Heart Failure (GWTG-HF).

PubMed

Luo, Nancy; Fonarow, Gregg C; Lippmann, Steven J; Mi, Xiaojuan; Heidenreich, Paul A; Yancy, Clyde W; Greiner, Melissa A; Hammill, Bradley G; Hardy, N Chantelle; Turner, Stuart J; Laskey, Warren K; Curtis, Lesley H; Hernandez, Adrian F; Mentz, Robert J; O'Brien, Emily C

2017-04-01

The aim of this study was to assess the prevalence and variation in angiotensin receptor/neprilysin inhibitor (ARNI) prescription among a real-world population with heart failure with reduced ejection fraction (HFrEF). The U.S. Food and Drug Administration approved sacubitril/valsartan for patients with HFrEF in July 2015. Little is known about the early patterns of use of this novel therapy. The study included patients discharged alive from hospitals in Get With the Guidelines-Heart Failure (GWTG-HF), a registry of hospitalized patients with heart failure, between July 2015 and June 2016 who had documentation of whether ARNIs were prescribed at discharge. Patient and hospital characteristics were compared among patients with HFrEF (ejection fraction ≤40%) with and without ARNI prescription at discharge, excluding those with documented contraindications to ARNIs. To evaluate hospital variation, hospitals with at least 10 eligible hospitalizations during the study period were assessed. Of 21,078 patients hospitalized with HFrEF during the study period, 495 (2.3%) were prescribed ARNIs at discharge. Patients prescribed ARNIs were younger (median age 65 years vs. 70 years; p < 0.001), had lower ejection fractions (median 23% vs. 25%; p < 0.001), and had higher use of aldosterone antagonists (45% vs. 31%; p < 0.001) at discharge. At the 241 participating hospitals with 10 or more eligible admissions, 125 (52%) reported no discharge prescriptions of ARNIs. Approximately 2.3% of patients hospitalized for HFrEF in a national registry were prescribed ARNI therapy in the first 12 months following Food and Drug Administration approval. Further study is needed to identify and overcome barriers to implementing new evidence into practice, such as ARNI use among eligible patients with HFrEF. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Computer-Based Patient Records: Better Planning and Oversight by VA, DOD, and IHS Would Enhance Health Data Sharing

DTIC Science & Technology

2001-04-01

IHS), could share information technology (IT) and patient medical information to provide greater continuity of care, accelerate VA eligibility... patient medical information to provide greater continuity of care, accelerate VA eligibility determinations, and save software development costs.1 In...system, which primarily includes information on patient hospital admission and discharge, patient medications , laboratory results, and radiology

The feasibility of conducting a randomised controlled trial comparing arthroscopic hip surgery to conservative care for patients with femoroacetabular impingement syndrome: the FASHIoN feasibility study.

PubMed

Griffin, D R; Dickenson, E J; Wall, P D H; Realpe, A; Adams, A; Parsons, N; Hobson, R; Achten, J; Costa, M L; Foster, N E; Hutchinson, C E; Petrou, S; Donovan, J L

2016-10-01

To determine whether it was feasible to perform a randomized controlled trial (RCT) comparing arthroscopic hip surgery to conservative care in patients with femoroacetabular impingement (FAI). This study had two phases: a pre-pilot and pilot RCT. In the pre-pilot, we conducted interviews with clinicians who treated FAI and with FAI patients to determine their views about an RCT. We developed protocols for operative and conservative care. In the pilot RCT, we determined the rates of patient eligibility, recruitment and retention, to investigate the feasibility of the protocol and we established methods to assess treatment fidelity. In the pre-pilot phase, 32 clinicians were interviewed, of which 26 reported theoretical equipoise, but in example scenarios 7 failed to show clinical equipoise. Eighteen patients treated for FAI were also interviewed, the majority of whom felt that surgery and conservative care were acceptable treatments. Surgery was viewed by patients as a 'definitive solution'. Patients were motivated to participate in research but were uncomfortable about randomization. Randomization was more acceptable if the alternative was available at the end of the trial. In the pilot phase, 151 patients were assessed for eligibility. Sixty were eligible and invited to take part in the pilot RCT; 42 consented to randomization. Follow-up was 100% at 12 months. Assessments of treatment fidelity were satisfactory. An RCT to compare arthroscopic hip surgery with conservative care in patients with FAI is challenging but feasible. Recruitment has started for a full RCT.

Assessment of the Incorporation of Patient-Centric Outcomes in Studies of Minimally Invasive Glaucoma Surgical Devices

PubMed Central

Le, Jimmy T.; Viswanathan, Shilpa; Tarver, Michelle E.; Eydelman, Malvina; Li, Tianjing

2017-01-01

IMPORTANCE Minimally invasive glaucoma surgical (MIGS) devices are one option for lowering intraocular pressure in patients with glaucoma. OBJECTIVE To examine how often existing clinical studies of MIGS devices registered on ClinicalTrials.gov measure patient-centric outcomes that patients value directly. DESIGN, SETTING, AND PARTICIPANTS We searched ClinicalTrials.gov, a registry of publicly and privately supported clinical studies, on February 20, 2015, for records of MIGS device studies involving patients with glaucoma. Two investigators independently abstracted study design and outcome details from eligible records. We classified outcomes as patient-centric or not patient-centric using a prespecified definition. MAIN OUTCOMES AND MEASURES Proportion of patient-centric and nonpatient-centric outcomes registered on ClinicalTrials.gov. RESULTS We identified 51 eligible studies specifying 127 outcomes. Reduction in intraocular pressure was the most frequent outcome specified (78/127; 61%) and a primary outcome in 41 studies. Patient-centric outcomes—such as adverse events (n = 19; 15%), topical medication use (n = 16; 13%), visual acuity (n = 4; 3%), and health-related quality of life (n = 1; 1%)—were less frequently specified (n = 40; 32%) and a primary outcome in only 12 studies. CONCLUSION AND RELEVANCE Patient-centric outcomes that provide insight into the relative desirability and acceptability of the benefits and risks of MIGS devices are not well represented in current clinical studies. PMID:27389667

Observational cohort study of pediatric inpatients with central venous catheters at "intermediate risk" of thrombosis and eligible for anticoagulant prophylaxis.

PubMed

Harney, Kathy M; McCabe, Margaret; Branowicki, Patricia; Kalish, Leslie A; Neufeld, Ellis J

2010-01-01

The risk of deep vein thrombosis (DVT) among hospitalized children is rising.The optimal approach to DVT prophylaxis in children is unclear. This study set out to ascertain the prevalence of DVT among pediatric inpatients who neither have contraindications to nor absolute indications for prophylactic therapy. A prospective surveillance of at-risk children plus a retrospective chart review were conducted. Patients were considered to be at risk after the first 2 days of their admission. Of 1,637 patients reviewed, 198 patients met criteria; among these, 84% did not receive prophylaxis. Of 2,354 observed days at risk for nonprophylaxed patients (including days at risk prior to initiating prophylaxis among prophlyaxed patients), there were 9 DVT events, for a rate 3.82/1,000 days observed. A total of 31 patients received prophylaxis. Three of these patients experienced a DVT. One patient had a bleeding event, hematuria. These results describe patients who may be eligible for prophylaxis and should be screened for further risk factors.

Development of a framework to improve the process of recruitment to randomised controlled trials (RCTs): the SEAR (Screened, Eligible, Approached, Randomised) framework.

PubMed

Wilson, Caroline; Rooshenas, Leila; Paramasivan, Sangeetha; Elliott, Daisy; Jepson, Marcus; Strong, Sean; Birtle, Alison; Beard, David J; Halliday, Alison; Hamdy, Freddie C; Lewis, Rebecca; Metcalfe, Chris; Rogers, Chris A; Stein, Robert C; Blazeby, Jane M; Donovan, Jenny L

2018-01-19

Research has shown that recruitment to trials is a process that stretches from identifying potentially eligible patients, through eligibility assessment, to obtaining informed consent. The length and complexity of this pathway means that many patients do not have the opportunity to consider participation. This article presents the development of a simple framework to document, understand and improve the process of trial recruitment. Eight RCTs integrated a QuinteT Recruitment Intervention (QRI) into the main trial, feasibility or pilot study. Part of the QRI required mapping the patient recruitment pathway using trial-specific screening and recruitment logs. A content analysis compared the logs to identify aspects of the recruitment pathway and process that were useful in monitoring and improving recruitment. Findings were synthesised to develop an optimised simple framework that can be used in a wide range of RCTs. The eight trials recorded basic information about patients screened for trial participation and randomisation outcome. Three trials systematically recorded reasons why an individual was not enrolled in the trial, and further details why they were not eligible or approached, or declined randomisation. A framework to facilitate clearer recording of the recruitment process and reasons for non-participation was developed: SEAR - Screening, to identify potentially eligible trial participants; Eligibility, assessed against the trial protocol inclusion/exclusion criteria; Approach, the provision of oral and written information and invitation to participate in the trial, and Randomised or not, with the outcome of randomisation or treatment received. The SEAR framework encourages the collection of information to identify recruitment obstacles and facilitate improvements to the recruitment process. SEAR can be adapted to monitor recruitment to most RCTs, but is likely to add most value in trials where recruitment problems are anticipated or evident. Further work to test it more widely is recommended.

Health Services Utilization Among Fee-for-Service Medicare and Medicaid Patients Under Age 65 with Behavioral Health Illness at an Urban Safety Net Hospital.

PubMed

Cancino, Ramon S; Jack, Brian W; Jarvis, John; Cummings, Alice Kate; Cooper, Ellie; Cremieux, Pierre-Yves; Burgess, James F

2017-07-01

In 2011, fee-for-service patients with both Medicare and Medicaid (dual eligible) sustained $319.5 billion in health care costs. To describe the emergency department (ED) use and hospital admissions of adult dual eligible patients aged under 65 years who used an urban safety net hospital. This was a retrospective database analysis of patients aged between 18 and 65 years with Medicare and Medicaid, who used an urban safety net academic health center between January 1, 2011, and December 31, 2011. We compared patients with and without behavioral health illness. The main outcome measures were hospital admission and ED use. Chi-square and Wilcoxon rank-sum tests were used for descriptive statistics on categorical and continuous variables, respectively. Greedy propensity score matching was used to control for confounding factors. Rate ratios (RR) and 95% confidence intervals (CI) were determined after matching and after adjusting for those variables that remained significantly different after matching. In 2011, 10% of all fee-for-service dual eligible patients aged less than 65 years in Massachusetts were seen at Boston Medical Center. Data before propensity score matching showed significant differences in age, sex, race/ethnicity, marital status, education, employment, physical comorbidities, and Charlson Comorbidity Index score between patients with and without behavioral health illness. Analysis after propensity score matching found significant differences in sex, Hispanic race, and other education and employment status. Compared with patients without behavioral health illness, patients with behavioral health illness had a higher RR for hospital admissions (RR = 2.07; 95% CI = 1.81-2.38; P < 0.001) and ED use (RR = 1.61; 95% CI = 1.46-1.77; P < 0.001). Results were robust after adjusting for characteristics that remained statistically significantly different after propensity score matching. Adult dual eligible patients aged less than 65 years with behavioral health illness in the Medicaid fee-for-service plan had significantly higher rates of hospital admission and ED use compared with dual eligible patients without behavioral health illness at the largest urban safety net medical center in New England. Safety net hospitals care for a large proportion of dual eligible patients with behavioral health illness. Further research is needed to elucidate the systems-related and patient-centered factors contributing to the utilization behaviors of this patient population. This research was funded in part by a National Research Service Award (T3HP10028-14-01). The authors have no conflicts of interests to disclose. Cancino had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design were contributed by Cancino, Jack, and Burgess, with assistance from Cremieux. Cancino and Cremieux took the lead in data collection, along with Jack and Burgess, and data interpretation was performed by Jarvis, Cummings, and Cooper, along with the other authors. The manuscript was written primarily by Cancino, along with Jack and Burgess, and revised primarily by Cancino, along with the other authors.

State-of-the-science of patient navigation as a strategy for enhancing minority clinical trial accrual.

PubMed

Ghebre, Rahel G; Jones, Lovell A; Wenzel, Jennifer A; Martin, Michelle Y; Durant, Raegan W; Ford, Jean G

2014-04-01

Patient navigation programs are emerging that aim to address disparities in clinical trial participation among medically underserved populations, including racial/ethnic minorities. However, there is a lack of consensus on the role of patient navigators within the clinical trial process as well as outcome measures to evaluate program effectiveness. A review of the literature was conducted of PubMed, Medline, CINHAL, and other sources to identify qualitative and quantitative studies on patient navigation in clinical trials. The search yielded 212 studies, of which only 12 were eligible for this review. The eligible studies reported on the development of programs for patient navigation in cancer clinical trials, including training and implementation among African Americans, American Indians, and Native Hawaiians. A low rate of clinical trial refusal (range, 4%-6%) was reported among patients enrolled in patient navigation programs. However, few studies reported on the efficacy of patient navigation in increasing clinical treatment trial enrollment. Outcome measures are proposed to assist in developing and evaluating the efficacy and/or effectiveness of patient navigation programs that aim to increase participation in cancer clinical trials. Future research is needed to evaluate the efficacy of patient navigators in addressing barriers to clinical trial participation and increasing enrollment among medically underserved cancer patients. © 2014 American Cancer Society.

State-of-the-Science of Patient Navigation as a Strategy for Enhancing Minority Clinical Trial Accrual

PubMed Central

Ghebre, Rahel G.; Jones, Lovell A.; Wenzel, Jennifer; Martin, Michelle Y.; Durant, Raegan; Ford, Jean G.

2014-01-01

Background Patient navigation programs are emerging, that aim to address disparities in clinical trial participation among medically underserved populations, including racial/ethnic minorities. However, there is a lack of consensus on the role of patient navigators within the clinical trial process, as well as outcome measures to evaluate program effectiveness. Methods A review of the literature was conducted of PubMed, Medline, CINHAL, and other sources to identify qualitative and quantitative studies on patient navigation in clinical trials. The search yielded 212 studies, of which only 12 were eligible for this review. Results The eligible studies reported on development of programs for patient navigation in cancer clinical trials, including training and implementation among African American, American Indian and Native Hawaiians. Low clinical trial refusal, 4% to 6%, was reported among patients enrolled in patient navigation program. However, few studies reported on the efficacy of patient navigation on increasing clinical treatment trial enrollment. Conclusion Outcome measures are proposed to assist in developing and evaluating the efficacy and/or effectiveness of patient navigation programs that aim to increase participation in cancer clinical trials. Future research is needed to evaluate the efficacy of patient navigators in addressing barriers to clinical trial participation and increasing enrollment among medically underserved cancer patients. PMID:24643650

The effectiveness of a student volunteer program for research in a pediatric Emergency Department.

PubMed

Steadman, Patrick E; Crudden, Johanna; Naranian, Taline; Oliveria, John Paul; Boutis, Kathy

2015-01-01

Emergency Department (ED) student-based research assistant programs have been shown to be effective in enrolling patients when the students receive university course credit or pay. However, the impact on research outcomes when university students act as volunteers in this role is relatively unknown. The main objective of this study was to determine how often potentially eligible children were accurately identified by volunteer research assistants for enrollment into prospective research in the ED. We also examined the frequency of successful enrollments and the accuracy of data capture. This was a prospective cross-sectional study of university student volunteer research assistant performance in a tertiary care pediatric ED between March 2011 and July 2013. The participant's primary role was to screen and facilitate enrollment of ED patients into clinical research. For each volunteer, we recorded demographics, number of screenings, enrollments, and data capture accuracy. Over five 6-month sessions, 151 student volunteers participated. Of these, 77.3% were female, 58.8% were undergraduate students, and 61.1% were interested in medical school. Student volunteers accurately screened 11,362/13,067 (87.0%) children, and they accurately identified 4407/4984 (88.4%) potentially eligible children for study enrollment. Of the 3805 eligible for enrollment exclusively by the students, 3228 (84.8%) families/children consented and completed all study procedures. Furthermore, students correctly entered 11,660/12,567 (92.8%) data points. Utilizing university student volunteers to facilitate research enrollment in the ED is effective and allows for the capture of a high percentage of potentially eligible patients into prospective clinical research studies. Copyright © 2015 Elsevier Inc. All rights reserved.

Warfarin for prevention of thromboembolism in atrial fibrillation: comparison of patient characteristics and outcomes of the "Real-World" Michigan Anticoagulation Quality Improvement Initiative (MAQI2) registry to the RE-LY, ROCKET-AF, and ARISTOTLE trials.

PubMed

Hughey, Andrew B; Gu, Xiaokui; Haymart, Brian; Kline-Rogers, Eva; Almany, Steve; Kozlowski, Jay; Besley, Dennis; Krol, Gregory D; Ahsan, Syed; Kaatz, Scott; Froehlich, James B; Barnes, Geoffrey D

2018-06-14

Randomized controlled trials (RCTs) examining warfarin use for stroke prevention in atrial fibrillation (AF) may not accurately reflect real-world populations. We aimed to determine the representativeness of the RCT populations to real-world patients and to describe differences in the characteristics of trial populations from trial eligible patients in a real-world setting. We hypothesized that a significant fraction of real-world patients would not qualify for the RE-LY, ROCKET-AF, and ARISTOTLE trials and that real-world patients qualifying for the studies may have more strokes and bleeding events. We compared the inclusion and exclusion criteria, patient characteristics, and clinical outcomes from RE-LY, ROCKET-AF, and ARISTOTLE against data from the Michigan Anticoagulation Quality Improvement Initiative (MAQI 2 ), a regional network of six community- and academic-based anticoagulation clinics. Of the 1446 non-valvular AF patients in the MAQI 2 registry taking warfarin, approximately 40-60% would meet the selection criteria used in RE-LY (788, 54.5%), ROCKET-AF (566, 39.1%), and ARISTOTLE (866, 59.9%). The most common reasons for exclusion from one or more trial were anemia (15.1%), other concurrent medications (11.2%), and chronic kidney disease (9.4%). Trial-eligible MAQI 2 patients were older, more frequently female, with a higher rate of paroxysmal AF, and lower rates of congestive heart failure, previous stroke, and previous myocardial infarction than the trial populations. MAQI 2 patients eligible for each trial had a lower rate of stroke and similar rate of major bleeding than was observed in the trials. A sizable proportion of real-world AF patients managed in anticoagulation clinics would not have been eligible for the RE-LY, ROCKET-AF, and ARISOTLE trials. The expected stroke risk reduction and bleeding risk among real-world AF patients on warfarin may not be congruent with published clinical trial data.

Patient-centered recruitment and retention for a randomized controlled study.

PubMed

Chhatre, Sumedha; Jefferson, Ashlie; Cook, Ratna; Meeker, Caitlin R; Kim, Ji Hyun; Hartz, Kayla Marie; Wong, Yu-Ning; Caruso, Adele; Newman, Diane K; Morales, Knashawn H; Jayadevappa, Ravishankar

2018-03-27

Recruitment and retention strategies for patient-centered outcomes research are evolving and research on the subject is limited. In this work, we present a conceptual model of patient-centered recruitment and retention, and describe the recruitment and retention activities and related challenges in a patient-centered comparative effectiveness trial. This is a multicenter, longitudinal randomized controlled trial in localized prostate cancer patients. We recruited 743 participants from three sites over 15 months period (January 2014 to March 2015), and followed them for 24 months. At site 1, of the 773 eligible participants, 551 (72%) were enrolled. At site 2, 34 participants were eligible and 23 (68%) enrolled. Of the 434 eligible participants at site 3, 169 (39%) enrolled. We observed that strategies related to the concepts of trust (e.g., physician involvement, ensuring protection of information), communication (e.g., brochures and pamphlets in physicians' offices, continued contact during regular clinic visits and calling/emailing assessment), attitude (e.g., emphasizing the altruistic value of research, positive attitude of providers and research staff), and expectations (e.g., full disclosure of study requirements and time commitment, update letters) facilitated successful patient recruitment and retention. A stakeholders' advisory board provided important input for the recruitment and retention activities. Active engagement, reminders at the offices, and personalized update letters helped retention during follow-up. Usefulness of telephone recruitment was site specific and, at one site, the time requirement for telephone recruitment was a challenge. We have presented multilevel strategies for successful recruitment and retention in a clinical trial using a patient-centered approach. Our strategies were flexible to accommodate site-level requirements. These strategies as well as the challenges can aid recruitment and retention efforts of future large-scale, patient-centered research studies. Clinicaltrials.gov , ID: NCT02032550 . Registered on 22 November 2013.

Impact of modality choice on rates of hospitalization in patients eligible for both peritoneal dialysis and hemodialysis.

PubMed

Quinn, Robert R; Ravani, Pietro; Zhang, Xin; Garg, Amit X; Blake, Peter G; Austin, Peter C; Zacharias, James M; Johnson, John F; Pandeya, Sanjay; Verrelli, Mauro; Oliver, Matthew J

2014-01-01

Hospitalization rates are a relevant consideration when choosing or recommending a dialysis modality. Previous comparisons of peritoneal dialysis (PD) and hemodialysis (HD) have not been restricted to individuals who were eligible for both therapies. ♢ We conducted a multicenter prospective cohort study of people 18 years of age and older who were eligible for both PD and HD, and who started outpatient dialysis between 2007 and 2010 in four Canadian dialysis programs. Zero-inflated negative binomial models, adjusted for baseline patient characteristics, were used to examine the association between modality choice and rates of hospitalization. ♢ The study enrolled 314 patients. A trend in the HD group toward higher rates of hospitalization, observed in the primary analysis, became significant when modality was treated as a time-varying exposure or when the population was restricted to elective outpatient starts in patients with at least 4 months of pre-dialysis care. Cardiovascular disease, infectious complications, and elective surgery were the most common reasons for hospital admission; only 23% of hospital stays were directly related to complications of dialysis or kidney disease. ♢ Efforts to promote PD utilization are unlikely to result in increased rates of hospitalization, and efforts to reduce hospital admissions should focus on potentially avoidable causes of cardiovascular disease and infectious complications.

Eligibility for Statin Therapy by the JUPITER Trial Criteria and Subsequent Mortality (From the REGARDS Cohort)

PubMed Central

Cushman, Mary; McClure, Leslie A.; Lakoski, Susan G.; Jenny, Nancy S.

2009-01-01

The Justification of the Use of Statins in Primary Prevention: an Intervention Trial Using Rosuvastatin (JUPITER) reported reduced cardiovascular and all-cause mortality with statin treatment in patients with elevated C-reactive protein (CRP) and average cholesterol, who were not eligible for lipid-lowering treatment based on existing guidelines. We determined the prevalence of eligibility and mortality in a general population sample based on eligibility for statin treatment using JUPITER criteria. We studied 30,229 participants of the REasons for Geographic And Racial Differences in Stroke (REGARDS) cohort, an observational study of US African-American and white participants aged 45 and older, enrolled in their homes between 2003–2007, and followed biannually by telephone. Among 11,339 participants age-eligible for JUPITER and without a vascular diagnosis or using lipid-lowering treatment, 21% (2,342) met JUPITER entry criteria. Compared to JUPITER participants, they had similar LDL cholesterol and CRP, were more often women, black, had metabolic syndrome and used aspirin for cardioprotection. Over 3.5 years follow-up, the mortality rate among REGARDS participants eligible for JUPITER was 1.17 per 100 person-years (95% CI 0.94–1.42). Compared to those otherwise JUPITER eligible who had CRP <2 mg/L (n=2,620), those with CRP ≥2 mg/L had a multivariable-adjusted relative risk of 1.5 (95% CI, 1.1–2.2) for total mortality. In conclusion, 21% not otherwise eligible would be newly eligible for lipid-lowering treatment based on JUPITER trial eligibility. PMID:20102894

Chronic Use of Theophylline and Mortality in Chronic Obstructive Pulmonary Disease: A Meta-analysis.

PubMed

Horita, Nobuyuki; Miyazawa, Naoki; Kojima, Ryota; Inoue, Miyo; Ishigatsubo, Yoshiaki; Kaneko, Takeshi

2016-05-01

Theophylline has been shown to improve respiratory function and oxygenation in patients with chronic obstruction pulmonary disease (COPD). However, the impact of theophylline on mortality in COPD patients has not been not sufficiently evaluated. Two investigators independently searched for eligible articles in 4 databases. The eligibility criterion for this meta-analysis was an original research article that provided a hazard ratio for theophylline for all-cause mortality of COPD patients. Both randomized controlled trials and observational studies were accepted. After we confirmed no substantial heterogeneity (I(2)<50%), the fixed-model method with generic inverse variance was used for meta-analysis to estimate the pooled hazard ratio. We screened 364 potentially eligible articles. Of the 364 articles, 259 were excluded on the basis of title and abstract, and 99 were excluded after examination of the full text. Our final analysis included 6 observational studies and no randomized controlled trials. One study reported 2 cohorts. The number of patients in each cohort ranged from 47 to 46,403. Heterogeneity (I(2)=42%, P=.11) and publication bias (Begg's test r=0.21, P=.662) were not substantial. Fixed-model meta-analysis yielded a pooled hazard ratio for theophylline for all-cause death of 1.07 (95% confidence interval: 1.02-1.13, P=.003). This meta-analysis of 7 observational cohorts suggests that theophylline slightly increases all-cause death in COPD patients. Copyright © 2014 SEPAR. Published by Elsevier Espana. All rights reserved.

A patient with MEN1 and end-stage chronic kidney disease due to Alport syndrome: Decision making on the eligibility of transplantation.

PubMed

Matrone, Antonio; Brancatella, Alessandro; Marchetti, Piero; Vasile, Enrico; Boggi, Ugo; Elisei, Rossella; Cetani, Filomena; Marcocci, Claudio; Vitti, Paolo; Latrofa, Francesco

2018-03-01

Absence of neoplastic disease in the organ-recipient is required in order to allow organ transplantation. Due to its rarity, no data regarding management of patients with Multiple endocrine neoplasia type 1 (MEN1) and end-stage renal failure candidates for kidney transplantation are available. A 36 year-old man was referred to the present hospital with MEN1, with a neuroendocrine pancreatic tumor and primary hyperparathyroidism and associated Alport syndrome with end stage renal failure. The present study aimed to establish the eligibility of the patient for a kidney transplantation. The neuroendocrine tumor had been treated with duodenopancreatectomy two years earlier and hyperparathyroidism by parathyroidectomy. The review of the literature did not provide data regarding the eligibility for kidney transplantation of patients harboring a neuroendocrine pancreatic tumor in the context of MEN1. Due to the end-stage renal failure, neuroendocrine markers were unreliable and the investigation therefore relied on imaging studies, which were unremarkable. Young age, low-grade tumor, low expression of Ki67, absence of metastatic lymph nodes, onset in the setting of a MEN1 were all positive prognostic factors of the neuroendocrine tumor. Normal serum calcium ruled out persistent primary hyperparathyroidism. Overall, hemodyalisis is known to significantly reduce life expectancy. Benefits of kidney transplantation overcome the risk of neuroendocrine tumor recurrence in a young patient bearing MEN1.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kowalchik, Kristin V.; Vallow, Laura A., E-mail: vallow.laura@mayo.edu; McDonough, Michelle

Purpose: To study the utility of preoperative breast MRI for partial breast irradiation (PBI) patient selection, using multivariable analysis of significant risk factors to create a classification rule. Methods and Materials: Between 2002 and 2009, 712 women with newly diagnosed breast cancer underwent preoperative bilateral breast MRI at Mayo Clinic Florida. Of this cohort, 566 were retrospectively deemed eligible for PBI according to the National Surgical Adjuvant Breast and Bowel Project Protocol B-39 inclusion criteria using physical examination, mammogram, and/or ultrasound. Magnetic resonance images were then reviewed to determine their impact on patient eligibility. The patient and tumor characteristics weremore » evaluated to determine risk factors for altered PBI eligibility after MRI and to create a classification rule. Results: Of the 566 patients initially eligible for PBI, 141 (25%) were found ineligible because of pathologically proven MRI findings. Magnetic resonance imaging detected additional ipsilateral breast cancer in 118 (21%). Of these, 62 (11%) had more extensive disease than originally noted before MRI, and 64 (11%) had multicentric disease. Contralateral breast cancer was detected in 28 (5%). Four characteristics were found to be significantly associated with PBI ineligibility after MRI on multivariable analysis: premenopausal status (P=.021), detection by palpation (P<.001), first-degree relative with a history of breast cancer (P=.033), and lobular histology (P=.002). Risk factors were assigned a score of 0-2. The risk of altered PBI eligibility from MRI based on number of risk factors was 0:18%; 1:22%; 2:42%; 3:65%. Conclusions: Preoperative bilateral breast MRI altered the PBI recommendations for 25% of women. Women who may undergo PBI should be considered for breast MRI, especially those with lobular histology or with 2 or more of the following risk factors: premenopausal, detection by palpation, and first-degree relative with a history of breast cancer.« less

Factors associated with loss to clinic among HIV patients not yet known to be eligible for antiretroviral therapy (ART) in Mozambique

PubMed Central

Pati, Rituparna; Lahuerta, Maria; Elul, Batya; Okamura, Mie; Alvim, Maria Fernanda; Schackman, Bruce; Bang, Heejung; Fernandes, Rufino; Assan, Americo; Lima, Josue; Nash, Denis

2013-01-01

Introduction Retention in HIV care prior to ART initiation is generally felt to be suboptimal, but has not been well-characterized. Methods We examined data on 37,352 adult pre-ART patients (ART ineligible or unknown eligibility) who enrolled in care during 2005–2008 with >1 clinical visit at 23 clinics in Mozambique. We defined loss to clinic (LTC) as >12 months since the last visit among those not known to have died/transferred. Cox proportional-hazards models were used to examine factors associated with LTC, accounting for clustering within sites. Results Of 37,352 pre-ART patients, 61% had a CD4 count within three months of enrolment (median CD4: 452, IQR: 345–611). 17,598 (47.1%) were ART ineligible and 19,754 (52.9%) were of unknown eligibility status at enrolment because of missing information on CD4 count and/or WHO stage. Kaplan-Meier estimates for LTC at 12 months were 41% (95% CI: 40.2–41.8) and 48% (95% CI: 47.2–48.8), respectively. Factors associated with LTC among ART ineligible patients included male sex (AHRmen_vs_non-pregnant women: 1.5; 95% CI: 1.4–1.6) and being pregnant at enrolment (AHRpregnant_vs_non-pregnant women: 1.3; 95% CI: 1.1–1.5). Older age, more education, higher weight and more advanced WHO stage at enrolment were independently associated with lower risks of LTC. Similar findings were observed among patients whose ART eligibility status was unknown at enrolment. Conclusions Substantial LTC occurred prior to ART initiation among patients not yet known to be eligible for ART, including nearly half of patients without documented ART eligibility assessment. Interventions are needed to target pre-ART patients who may be at higher risk for LTC, including pregnant women and patients with less advanced HIV disease. PMID:23755857

Potential Adult Medicaid Beneficiaries Under the Patient Protection and Affordable Care Act Compared With Current Adult Medicaid Beneficiaries

PubMed Central

Chang, Tammy; Davis, Matthew

2013-01-01

PURPOSE Under health care reform, states will have the opportunity to expand Medicaid to millions of uninsured US adults. Information regarding this population is vital to physicians as they prepare for more patients with coverage. Our objective was to describe demographic and health characteristics of potentially eligible Medicaid beneficiaries. METHODS We performed a cross-sectional study using data from the National Health and Nutrition Examination Survey (2007–2010) to identify and compare adult US citizens potentially eligible for Medicaid under provisions of the Patient Protection and Affordable Care Act (ACA) with current adult Medicaid beneficiaries. We compared demographic characteristics (age, sex, race/ethnicity, education) and health measures (self-reported health status; measured body mass index, hemoglobin A1c level, systolic and diastolic blood pressure, depression screen [9-item Patient Health Questionnaire], tobacco smoking, and alcohol use). RESULTS Analyses were based on an estimated 13.8 million current adult non-elderly Medicaid beneficiaries and 13.6 million nonelderly adults potentially eligible for Medicaid. Potentially eligible individuals are expected to be more likely male (49.2% potentially eligible vs 33.3% current beneficiaries; P <.001), to be more likely white and less likely black (58.8% white, 20.0% black vs 49.9% white, 25.2% black; P = .02), and to be statistically indistinguishable in terms of educational attainment. Overall, potentially eligible adults are expected to have better health status (34.8% “excellent” or “very good,” 40.4% “good”) than current beneficiaries (33.5% “excellent” or “very good,” 31.6% “good”; P <.001). The proportions obese (34.5% vs 42.9%; P = .008) and with depression (15.5% vs 22.3%; P = .003) among potentially eligible individuals are significantly lower than those for current beneficiaries, while there are no significant differences in the expected prevalence of diabetes or hypertension. Current tobacco smoking (49.2% vs 38.0%; P = .002), and moderate and heavier alcohol use (21.6% vs 16.0% and 16.5% vs 9.8%; P <.001, respectively) are more common among the potentially eligible population than among current beneficiaries. CONCLUSIONS Under the ACA, physicians can anticipate a potentially eligible Medicaid population with equal if not better current health status and lower prevalence of obesity and depression than current Medicaid beneficiaries. Federal Medicaid expenditures for newly covered beneficiaries therefore may not be as high as anticipated in the short term. Given the higher prevalence of tobacco smoking and alcohol use, however, broad enrollment and engagement of this potentially eligible population is needed to address their higher prevalence of modifiable risk factors for future chronic disease. PMID:24019271

Cost-effective recruitment methods for a large randomised trial in people with diabetes: A Study of Cardiovascular Events iN Diabetes (ASCEND).

PubMed

Aung, Theingi; Haynes, Richard; Barton, Jill; Cox, Jolyon; Murawska, Aleksandra; Murphy, Kevin; Lay, Michael; Armitage, Jane; Bowman, Louise

2016-06-13

Clinical trials require cost-effective methods for identifying, randomising, and following large numbers of people in order to generate reliable evidence. ASCEND (A Study of Cardiovascular Events iN Diabetes) is a randomised '2 × 2 factorial design' study of aspirin and omega-3 fatty acid supplements for the primary prevention of cardiovascular events in people with diabetes; this study used central disease registers and a mail-based approach to identify, randomise, and follow 15,000 people. In collaboration with UK consultants and general practitioners (GPs), researchers identified potentially eligible people with diabetes from centrally held registers (e.g. for retinopathy screening) and GP-held disease registers. Permission was obtained under section 251 of the National Health Service Act 2006 (previously section 60 of the NHS act 2001) to allow invitation letters to be generated centrally in the name of the holder of the register. In addition, with the collaboration of the National Institutes for Health Research (NIHR) Diabetes and Primary Care Research Networks (DRN and PCRN), general practices sent pre-assembled invitation packs to people with a diagnosis of diabetes. Invitation packs included a cover letter, screening questionnaire (with consent form), information leaflet, and a Freepost envelope. Eligible patients entered a 2-month, pre-randomisation, run-in phase on placebo tablets and were only randomised if they completed a randomisation form and remained willing and eligible at the end of the run-in. Follow-up is ongoing, using mail-based approaches that are being supplemented by central registry data. Information on approximately 600,000 people listed on 58 centrally held diabetes registers was obtained, and 300,188 potentially eligible patients were invited to join the study. In addition, 785 GP practices mailed invitations to 120,875 patients. A further 2,340 potential study participants were identified via other routes. In total, 423,403 people with diabetes were invited to take part; 26,462 entered the 2-month, pre-randomisation, run-in phase; and 15,480 were randomised. If sufficient numbers of potentially eligible patients can be identified centrally and the trial treatments do not require participants to attend clinics, the recruitment and follow-up of patients by mail is feasible and cost-effective. Wider use of these methods could allow more, large, randomised trials to be undertaken successfully and cost-effectively. Current Controlled Trials, ISRCTN60635500 , registered on 14 July 2005.

High pre-diagnosis attrition among patients with presumptive MDR-TB: an operational research from Bhopal district, India.

PubMed

Shewade, Hemant Deepak; Kokane, Arun M; Singh, Akash Ranjan; Verma, Manoj; Parmar, Malik; Chauhan, Ashish; Chahar, Sanjay Singh; Tiwari, Manoj; Khan, Sheeba Naz; Gupta, Vivek; Tripathy, Jaya Prasad; Nagar, Mukesh; Singh, Sanjai Kumar; Mehra, Pradeep Kumar; Kumar, Ajay Mv

2017-04-04

Pre-diagnosis attrition needs to be addressed urgently if we are to make progress in improving MDR-TB case detection and achieve universal access to MDR-TB care. We report the pre-diagnosis attrition, along with factors associated, and turnaround times related to the diagnostic pathway among patient with presumptive MDR-TB in Bhopal district, central India (2014). Study was conducted under the Revised National Tuberculosis Control Programme setting. It was a retrospective cohort study involving record review of all registered TB cases in Bhopal district that met the presumptive MDR-TB criteria (eligible for DST) in 2014. In quarter 1, Line Probe Assay (LPA) was used if sample was smear/culture positive. Quarter 2 onwards, LPA and Cartridge-based Nucleic Acid Amplification Test (CbNAAT) was used for smear positive and smear negative samples respectively. Pre-diagnosis attrition was defined as failure to undergo DST among patients with presumptive MDR-TB (as defined by the programme). Of 770 patients eligible for DST, 311 underwent DST and 20 patients were diagnosed as having MDR-TB. Pre-diagnosis attrition was 60% (459/770). Among those with pre-diagnosis attrition, 91% (417/459) were not identified as 'presumptive MDR-TB' by the programme. TAT [median (IQR)] to undergo DST after eligibility was 4 (0, 10) days. Attrition was more than 40% across all subgroups. Age more than 64 years; those from a medical college; those eligible in quarter 1; patients with presumptive criteria 'previously treated - recurrent TB', 'treatment after loss-to-follow-up' and 'previously treated-others'; and patients with extra-pulmonary TB were independent risk factors for not undergoing DST. High pre-diagnosis attrition was contributed by failure to identify and refer patients. Attrition reduced modestly with time and one factor that might have contributed to this was introduction of CbNAAT in quarter 2 of 2014. General health system strengthening which includes improvement in identification/referral and patient tracking with focus on those with higher risk for not undergoing DST is urgently required.

Engaging Patients in Decisions About Cancer Screening: Exploring the Decision Journey Through the Use of a Patient Portal.

PubMed

Woolf, Steven H; Krist, Alex H; Lafata, Jennifer Elston; Jones, Resa M; Lehman, Rebecca R; Hochheimer, Camille J; Sabo, Roy T; Frosch, Dominick L; Zikmund-Fisher, Brian J; Longo, Daniel R

2018-02-01

Engaging patients to make informed choices is paramount but difficult in busy practices. This study sought to engage patients outside the clinical setting to better understand how they approach cancer screening decisions, including their primary concerns and their preferences for finalizing their decision. Twelve primary care practices offering patients an online personal health record invited eligible patients to complete a 17-item online interactive module. Among 11,458 registered users, invitations to complete the module were sent to adults aged 50-74 years who were overdue for colorectal cancer screening and to women aged 40-49 years and men aged 55-69 who had not undergone a recent mammogram or prostate-specific antigen test, respectively. The module was started by 2,355 patients and completed by 903 patients. Most respondents (76.8%) knew they were eligible for screening. Preferred next steps were talking to the clinician (76.6%), reading/research (28.6%), and consulting trusted friends/family (16.4%). Priority topics included how much screening improves life expectancy, comparative test performance, and the prevalence/health risks of the cancer. Leading fears were getting cancer/delayed detection (79.2%), abnormal results (40.5%), and testing complications (39.1%), the last referring to false test results, medical complications, or unnecessary treatments. Men eligible for prostate-specific antigen screening were more likely than women eligible for mammography to express concerns about testing complications and to prioritize weighing pros and cons over gut feelings (p<0.05). Although this sample was predisposed to screening, most patients wanted help in finalizing their decision. Many wanted to weigh the pros and cons and expressed fears of potential harms from screening. Understanding how patients approach decisions may help design more effective engagement strategies. Copyright © 2017 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

National quality assessment evaluating spironolactone use during hospitalization for acute myocardial infarction (AMI) in China: China Patient-centered Evaluation Assessment of Cardiac Events (PEACE)-Retrospective AMI Study, 2001, 2006, and 2011.

PubMed

Guan, Wenchi; Murugiah, Karthik; Downing, Nicholas; Li, Jing; Wang, Qing; Ross, Joseph S; Desai, Nihar R; Masoudi, Frederick A; Spertus, John A; Li, Xi; Krumholz, Harlan M; Jiang, Lixin

2015-06-12

Spironolactone, the only aldosterone antagonist available in China, improves outcomes in acute myocardial infarction (AMI) among patients with systolic dysfunction and either diabetes or heart failure (HF). However, national practice patterns in the use of spironolactone in China are unknown. From a nationally representative sample of AMI patients from in 2001, 2006, and 2011, we identified 6906 patients with either diabetes or HF and classified them into 1 of 4 groups according to their eligibility for spironolactone-"ideal"(left ventricular ejection fraction [LVEF] ≤40% and without contraindications), "contraindicated," "not indicated" (neither ideal nor contraindicated), and "unknown indications" (LVEF unmeasured)-to determine how frequently patient eligibility for this drug is assessed in the hospital, how it is used in several groups, and to identify factors associated with the use in these groups. From 2001 to 2011, the proportion of patients whose eligibility for spironolactone was not assessed decreased (66.9% in 2001 to 32.8% in 2011). Spironolactone use significantly increased among ideal patients over this period (28.6% to 72.4%; P<0.001 for trend), but also in contraindicated patients (11.4% to 27.5%; P=0.002 for trend) and in other patients groups (not indicated: 27.5% to 38.3%; unknown indications: 21.3% to 35.1%; both P<0.01 for trend). In all 4 groups, patients presenting with HF on admission were more likely to receive spironolactone. Although the appropriate use of spironolactone and assessment of eligibility increased in China over the past decade, there remains marked opportunities for improvement. URL: http://www.clinicaltrials.gov Unique identifier: NCT01624883. © 2015 The Authors. Published on behalf of the American Heart Association, Inc, by Wiley Blackwell.

A Novel Patient Recruitment Strategy: Patient Selection Directly from the Community through Linkage to Clinical Data.

PubMed

Zimmerman, Lindsay P; Goel, Satyender; Sathar, Shazia; Gladfelter, Charon E; Onate, Alejandra; Kane, Lindsey L; Sital, Shelly; Phua, Jasmin; Davis, Paris; Margellos-Anast, Helen; Meltzer, David O; Polonsky, Tamar S; Shah, Raj C; Trick, William E; Ahmad, Faraz S; Kho, Abel N

2018-01-01

This article presents and describes our methods in developing a novel strategy for recruitment of underrepresented, community-based participants, for pragmatic research studies leveraging routinely collected electronic health record (EHR) data. We designed a new approach for recruiting eligible patients from the community, while also leveraging affiliated health systems to extract clinical data for community participants. The strategy involves methods for data collection, linkage, and tracking. In this workflow, potential participants are identified in the community and surveyed regarding eligibility. These data are then encrypted and deidentified via a hashing algorithm for linkage of the community participant back to a record at a clinical site. The linkage allows for eligibility verification and automated follow-up. Longitudinal data are collected by querying the EHR data and surveying the community participant directly. We discuss this strategy within the context of two national research projects, a clinical trial and an observational cohort study. The community-based recruitment strategy is a novel, low-touch, clinical trial enrollment method to engage a diverse set of participants. Direct outreach to community participants, while utilizing EHR data for clinical information and follow-up, allows for efficient recruitment and follow-up strategies. This new strategy for recruitment links data reported from community participants to clinical data in the EHR and allows for eligibility verification and automated follow-up. The workflow has the potential to improve recruitment efficiency and engage traditionally underrepresented individuals in research. Schattauer GmbH Stuttgart.

What proportion of prescription items dispensed in community pharmacies are eligible for the New Medicine Service?

PubMed

Wells, Katharine M; Boyd, Matthew J; Thornley, Tracey; Boardman, Helen F

2014-03-07

The payment structure for the New Medicine Service (NMS) in England is based on the assumption that 0.5% of prescription items dispensed in community pharmacies are eligible for the service. This assumption is based on a theoretical calculation. This study aimed to find out the actual proportion of prescription items eligible for the NMS dispensed in community pharmacies in order to compare this with the theoretical assumption. The study also aimed to investigate whether the proportion of prescription items eligible for the NMS is affected by pharmacies' proximity to GP practices. The study collected data from eight pharmacies in Nottingham belonging to the same large chain of pharmacies. Pharmacies were grouped by distance from the nearest GP practice and sampled to reflect the distribution by distance of all pharmacies in Nottingham. Data on one thousand consecutive prescription items were collected from each pharmacy and the number of NMS eligible items recorded. All NHS prescriptions were included in the sample. Data were analysed and proportions calculated with 95% confidence intervals used to compare the study results against the theoretical figure of 0.5% of prescription items being eligible for the NMS. A total of 8005 prescription items were collected (a minimum of 1000 items per pharmacy) of which 17 items were eligible to receive the service. The study found that 0.25% (95% confidence intervals: 0.14% to 0.36%) of prescription items were eligible for the NMS which differs significantly from the theoretical assumption of 0.5%. The opportunity rate for the service was lower, 0.21% (95% confidence intervals: 0.10% to 0.32%) of items, as some items eligible for the NMS did not translate into opportunities to offer the service. Of all the prescription items collected in the pharmacies, 28% were collected by patient representatives. The results of this study show that the proportion of items eligible for the NMS dispensed in community pharmacies is lower than the Department of Health assumption of 0.5%. This study did not find a significant difference in the rate of NMS opportunities between pharmacies located close to GP practices compared to those further away.

Eligibility for and outcome of treatment of latent tuberculosis infection in a cohort of HIV-infected people in Spain

PubMed Central

2010-01-01

Background Previous studies have demonstrated the efficacy of treatment for latent tuberculosis infection (TLTBI) in persons infected with the human immunodeficiency virus, but few studies have investigated the operational aspects of implementing TLTBI in the co-infected population.The study objectives were to describe eligibility for TLTBI as well as treatment prescription, initiation and completion in an HIV-infected Spanish cohort and to investigate factors associated with treatment completion. Methods Subjects were prospectively identified between 2000 and 2003 at ten HIV hospital-based clinics in Spain. Data were obtained from clinical records. Associations were measured using the odds ratio (OR) and its 95% confidence interval (95% CI). Results A total of 1242 subjects were recruited and 846 (68.1%) were evaluated for TLTBI. Of these, 181 (21.4%) were eligible for TLTBI either because they were tuberculin skin test (TST) positive (121) or because their TST was negative/unknown but they were known contacts of a TB case or had impaired immunity (60). Of the patients eligible for TLTBI, 122 (67.4%) initiated TLTBI: 99 (81.1%) were treated with isoniazid for 6, 9 or 12 months; and 23 (18.9%) with short-course regimens including rifampin plus isoniazid and/or pyrazinamide. In total, 70 patients (57.4%) completed treatment, 39 (32.0%) defaulted, 7 (5.7%) interrupted treatment due to adverse effects, 2 developed TB, 2 died, and 2 moved away. Treatment completion was associated with having acquired HIV infection through heterosexual sex as compared to intravenous drug use (OR:4.6; 95% CI:1.4-14.7) and with having taken rifampin and pyrazinamide for 2 months as compared to isoniazid for 9 months (OR:8.3; 95% CI:2.7-24.9). Conclusions A minority of HIV-infected patients eligible for TLTBI actually starts and completes a course of treatment. Obstacles to successful implementation of this intervention need to be addressed. PMID:20840743

Hormone Replacement Therapy and Opioid Tapering for Opioid-Induced Hypogonadism Among Patients with Chronic Noncancer Pain: A Systematic Review.

PubMed

AminiLari, Mahmood; Manjoo, Priya; Craigie, Samantha; Couban, Rachel; Wang, Li; Busse, Jason W

2018-05-02

To systematically review evidence addressing the efficacy of testosterone replacement therapy (TRT) and opioid tapering for opioid-induced hypogonadism among patients with chronic noncancer pain. Systematic review of randomized controlled trials (RCTs) and observational studies. We searched MEDLINE, CINAHL, AMED, CENTRAL, CINAHL, DARE, EMBASE, and PsycINFO through August 2017. Eligible studies enrolled ≥10 patients with chronic noncancer pain and opioid-induced hypogonadism and reported the effect of TRT or opioid tapering on a patient-important outcome collected ≥14 days after treatment. Pairs of reviewers independently screened for eligible studies, assessed risk of bias, and extracted data. We used the GRADE approach to rate quality of evidence. Of 666 abstracts reviewed, five studies including one RCT (N = 84) and four observational studies (N = 157) were eligible. No studies explored the effect of opioid tapering for opioid-induced hypogonadism. Very low-quality evidence found that TRT was associated with improvements in pain (median reduction of 2 points on the 11-point numerical rating scale for pain; 95% confidence interval [CI] = -1.4 to -2.6; minimally important difference [MID] = 2 points), and emotional functioning (mean increase of 9 points on the 100-point SF-36 Mental Component Summary score; 95% CI = 4.40 to 13.60; MID = 5 points). Low-quality evidence suggested that TRT had no effect on sleep quality, sexual function, physical functioning, role functioning, or social functioning; very low-quality evidence suggested no association with depressive symptoms. Low-quality to very low-quality evidence suggests that TRT may improve pain and emotional functioning, but not other outcomes, in chronic noncancer pain patients with opioid-induced hypogonadism.

The course and prognostic factors of symptomatic cervical disc herniation with radiculopathy: a systematic review of the literature.

PubMed

Wong, Jessica J; Côté, Pierre; Quesnele, Jairus J; Stern, Paula J; Mior, Silvano A

2014-08-01

Cervical spine disc herniation is a disabling source of cervical radiculopathy. However, little is known about its course and prognosis. Understanding the course and prognosis of symptomatic cervical disc herniation is necessary to guide patients' expectations and assist clinicians in managing patients. To describe the natural history, clinical course, and prognostic factors of symptomatic cervical disc herniations with radiculopathy. Systematic review of the literature and best evidence synthesis. A systematic search of MEDLINE, EMBASE, CINAHL, SportsDiscus, and the Cochrane Central Register of Controlled Trials from inception to 2013 was conducted to retrieve eligible articles. Eligible articles were critically appraised using the Scottish Intercollegiate Guidelines Network criteria. The results from articles with low risk of bias were analyzed using best evidence synthesis principles. We identified 1,221 articles. Of those, eight articles were eligible and three were accepted as having a low risk of bias. Two studies pertained to course and one study pertained to prognosis. Most patients with symptomatic cervical disc herniations with radiculopathy initially present with intense pain and moderate levels of disability. However, substantial improvements tend to occur within the first 4 to 6 months post-onset. Time to complete recovery ranged from 24 to 36 months in, approximately, 83% of patients. Patients with a workers' compensation claim appeared to have a poorer prognosis. Our best evidence synthesis describes the best available evidence on the course and prognosis of cervical disc herniations with radiculopathy. Most patients with symptomatic cervical spine disc herniation with radiculopathy recover. Possible recurrences and time to complete recovery need to be further studied. More studies are also needed to understand the prognostic factors for this condition. Copyright © 2014 Elsevier Inc. All rights reserved.

Trial Prospector: Matching Patients with Cancer Research Studies Using an Automated and Scalable Approach

PubMed Central

Sahoo, Satya S; Tao, Shiqiang; Parchman, Andrew; Luo, Zhihui; Cui, Licong; Mergler, Patrick; Lanese, Robert; Barnholtz-Sloan, Jill S; Meropol, Neal J; Zhang, Guo-Qiang

2014-01-01

Cancer is responsible for approximately 7.6 million deaths per year worldwide. A 2012 survey in the United Kingdom found dramatic improvement in survival rates for childhood cancer because of increased participation in clinical trials. Unfortunately, overall patient participation in cancer clinical studies is low. A key logistical barrier to patient and physician participation is the time required for identification of appropriate clinical trials for individual patients. We introduce the Trial Prospector tool that supports end-to-end management of cancer clinical trial recruitment workflow with (a) structured entry of trial eligibility criteria, (b) automated extraction of patient data from multiple sources, (c) a scalable matching algorithm, and (d) interactive user interface (UI) for physicians with both matching results and a detailed explanation of causes for ineligibility of available trials. We report the results from deployment of Trial Prospector at the National Cancer Institute (NCI)-designated Case Comprehensive Cancer Center (Case CCC) with 1,367 clinical trial eligibility evaluations performed with 100% accuracy. PMID:25506198

Does self-efficacy influence recovery and well-being in osteoarthritis patients undergoing joint replacement? A systematic review.

PubMed

Magklara, Eleni; Burton, Christopher R; Morrison, Val

2014-09-01

To investigate the role of self-efficacy in functional recovery and well-being outcomes in osteoarthritis patients, undergoing hip or knee replacement surgery. Studies were identified using MEDLINE via PUB med, PsycINFO and CINAHL from inception to July 2013. Three search strategies that combined key terms of 'self-efficacy', 'functional recovery', 'well-being' and 'joint replacement' were applied. Titles and abstracts were screened for eligibility and, accordingly, potentially eligible studies were retrieved for review. Included studies were assessed in terms of their quality, and data were extracted by two independent reviewers. A narrative synthesis of results was conducted. In total, 836 articles were identified and after electronic de-duplication, 708 articles remained. After screening 15 articles were retrieved as potentially eligible and eight articles were included in the review. Of the eight studies (n = 967 patients), seven had a prospective design and all studies were considered of good quality. No fully conclusive evidence for the influence of self-efficacy upon functional recovery outcomes was found. When the timing of self-efficacy measurement was examined, post-operative self-efficacy was found to be related to functional recovery outcomes. Presurgical self-efficacy was the least consistent predictor of functional outcomes while postoperative self-efficacy was more consistently associated with recovery outcomes such as longer distance ambulation, exercise repetition and frequency, walking speed and disability. © The Author(s) 2014.

Prevalence and spectrum of residual symptoms in Lyme neuroborreliosis after pharmacological treatment: a systematic review.

PubMed

Dersch, R; Sommer, H; Rauer, S; Meerpohl, J J

2016-01-01

Controversy exists about residual symptoms after pharmacological treatment of Lyme neuroborreliosis. Reports of disabling long-term sequels lead to concerns in patients and health care providers. We systematically reviewed the available evidence from studies reporting treatment of Lyme neuroborreliosis to assess the prevalence and spectrum of residual symptoms after treatment. A literature search was performed in three databases and three clinical trial registers to find eligible studies reporting on residual symptoms in patients after pharmacological treatment of LNB. Diagnosis must have been performed according to consensus-derived case definitions. No restrictions regarding study design or language were set. Symptom prevalence was pooled using a random-effects model. Forty-four eligible clinical trials and studies were found: 8 RCTs, 17 cohort studies, 2 case-control studies, and 17 case series. The follow-up period in the eligible studies ranged from 7 days to 20 years. The weighted mean proportion of residual symptoms was 28 % (95 % CI 23-34 %, n = 34 studies) for the latest reported time point. Prevalence of residual symptoms was statistically significantly higher in studies using the "possible" case definition (p = 0.0048). Cranial neuropathy, pain, paresis, cognitive disturbances, headache, and fatigue were statistically significantly lower in studies using the "probable/definite" case definition. LNB patients may experience residual symptoms after treatment with a prevalence of approximately 28 %. The prevalence and spectrum of residual symptoms differ according to the applied case definition. Symptoms like fatigue are not reported in studies using the "probable/definite" case definition. As the "possible" case definition is more unspecific, patients with other conditions may be included. Reports of debilitating fatigue and cognitive impairment after LNB, a "post-Lyme syndrome", could therefore be an artifact of unspecific case definitions in single studies.

Long-term outcomes after Roux-en-Y gastric bypass: 10- to 13-year data.

PubMed

Obeid, Nabeel R; Malick, Waqas; Concors, Seth J; Fielding, George A; Kurian, Marina S; Ren-Fielding, Christine J

2016-01-01

Short- and mid-term data on Roux-en-Y gastric bypass (RYGB) indicate sustained weight loss and improvement in co-morbidities. Few long-term studies exist, some of which are outdated, based on open procedures or different techniques. To investigate long-term weight loss, co-morbidity remission, nutritional status, and complication rates among patients undergoing RYGB. An academic, university hospital in the United States. Between October 2000 and January 2004, patients who underwent RYGB≥10 years before study onset were eligible for chart review, office visits, and telephone interviews. Revisional surgery was an endpoint, ceasing eligibility for study follow-up. Outcomes included weight loss measures and rates of co-morbidity remission, complications, and nutritional deficiencies. RYGB was performed in 328 patients with a mean preoperative body mass index of 47.5 kg/m(2). Of 294 eligible patients, 134 (46%) were contacted for follow-up at ≥ 10 years (10+Year follow-up). Mean percentage excess weight loss (%EWL) was 58.9% at 10+Year. Higher %EWL was achieved by non-super-obese versus super-obese (61.3% versus 52.9%, P = .034). Blood pressure, lipid panel, and hemoglobin A1c improved significantly. At 10 years, remission of co-morbidities was 46% for hypertension and hyperlipidemia and 58% for diabetes mellitus. Thirty patients (9%) had revisional surgery for weight regain. Sixty-four patients (19.5%) had long-term complications requiring surgery. All-cause mortality was 2.7%. Nutritional deficiencies were seen in 87% of patients. Weight loss after RYGB appears to be significant and sustainable, especially in the non-super-obese. Co-morbidities are improved, with a substantial number in remission a decade later. Nutritional deficiencies are almost universal. Copyright © 2016 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

Automated Risk Assessment for Stroke in Atrial Fibrillation (AURAS-AF)--an automated software system to promote anticoagulation and reduce stroke risk: study protocol for a cluster randomised controlled trial.

PubMed

Holt, Tim A; Fitzmaurice, David A; Marshall, Tom; Fay, Matthew; Qureshi, Nadeem; Dalton, Andrew R H; Hobbs, F D Richard; Lasserson, Daniel S; Kearley, Karen; Hislop, Jenny; Jin, Jing

2013-11-13

Patients with atrial fibrillation (AF) are at significantly increased risk of stroke. Oral anticoagulants (OACs) substantially reduce this risk, with gains seen across the spectrum of baseline risk. Despite the benefit to patients, OAC prescribing remains suboptimal in the United Kingdom (UK). We will investigate whether an automated software system, operating within primary care electronic medical records, can improve the management of AF by identifying patients eligible for OAC therapy and increasing uptake of this treatment. We will conduct a cluster randomised controlled trial, involving general practices using the Egton Medical Information Systems (EMIS) Web clinical system. We will randomise practices to use an electronic software tool or to continue with usual care. The tool will a) produce (and continually refresh) a list of patients with AF who are eligible for OAC therapy--practices will invite these patients to discuss therapy at the start of the trial--and b) generate electronic screen reminders in the medical records of those eligible, appearing throughout the trial. The software will run for 6 months in 23 intervention practices. A total of 23 control practices will manage their AF register in line with the usual care offered. The primary outcome is change in proportion of eligible patients with AF who have been prescribed OAC therapy after six months. Secondary outcomes are incidence of stroke, transient ischaemic attack, other major thromboembolism, major haemorrhage and reports of inappropriate OAC prescribing in the data collection sample--those deemed eligible for OACs. We will conduct a process evaluation in parallel with the randomised trial. We will use qualitative methods to examine patient and practitioner views of the intervention and its impact on primary care practice, including its time implications. AURAS-AF will investigate whether a simple intervention, using electronic primary care records, can improve OAC uptake in a high risk group for stroke. Given previous concerns about safety, especially surrounding inappropriate prescribing, we will also examine whether electronic reminders safely impact care in this clinical area. http://ISRCTN 55722437.

HIV treatment eligibility expansion and timely antiretroviral treatment initiation following enrollment in HIV care: A metaregression analysis of programmatic data from 22 countries.

PubMed

Tymejczyk, Olga; Brazier, Ellen; Yiannoutsos, Constantin; Wools-Kaloustian, Kara; Althoff, Keri; Crabtree-Ramírez, Brenda; Van Nguyen, Kinh; Zaniewski, Elizabeth; Dabis, Francois; Sinayobye, Jean d'Amour; Anderegg, Nanina; Ford, Nathan; Wikramanayake, Radhika; Nash, Denis

2018-03-01

The effect of antiretroviral treatment (ART) eligibility expansions on patient outcomes, including rates of timely ART initiation among those enrolling in care, has not been assessed on a large scale. In addition, it is not known whether ART eligibility expansions may lead to "crowding out" of sicker patients. We examined changes in timely ART initiation (within 6 months) at the original site of HIV care enrollment after ART eligibility expansions among 284,740 adult ART-naïve patients at 171 International Epidemiology Databases to Evaluate AIDS (IeDEA) network sites in 22 countries where national policies expanding ART eligibility were introduced between 2007 and 2015. Half of the sites included in this analysis were from Southern Africa, one-third were from East Africa, and the remainder were from the Asia-Pacific, Central Africa, North America, and South and Central America regions. The median age of patients enrolling in care at contributing sites was 33.5 years, and the median percentage of female patients at these clinics was 62.5%. We assessed the 6-month cumulative incidence of timely ART initiation (CI-ART) before and after major expansions of ART eligibility (i.e., expansion to treat persons with CD4 ≤ 350 cells/μL [145 sites in 22 countries] and CD4 ≤ 500 cells/μL [152 sites in 15 countries]). Random effects metaregression models were used to estimate absolute changes in CI-ART at each site before and after guideline expansion. The crude pooled estimate of change in CI-ART was 4.3 percentage points (95% confidence interval [CI] 2.6 to 6.1) after ART eligibility expansion to CD4 ≤ 350, from a baseline median CI-ART of 53%; and 15.9 percentage points (pp) (95% CI 14.3 to 17.4) after ART eligibility expansion to CD4 ≤ 500, from a baseline median CI-ART of 57%. The largest increases in CI-ART were observed among those newly eligible for treatment (18.2 pp after expansion to CD4 ≤ 350 and 47.4 pp after expansion to CD4 ≤ 500), with no change or small increases among those eligible under prior guidelines (CD4 ≤ 350: -0.6 pp, 95% CI -2.0 to 0.7 pp; CD4 ≤ 500: 4.9 pp, 95% CI 3.3 to 6.5 pp). For ART eligibility expansion to CD4 ≤ 500, changes in CI-ART were largest among younger patients (16-24 years: 21.5 pp, 95% CI 18.9 to 24.2 pp). Key limitations include the lack of a counterfactual and difficulty accounting for secular outcome trends, due to universal exposure to guideline changes in each country. These findings underscore the potential of ART eligibility expansion to improve the timeliness of ART initiation globally, particularly for young adults.

HIV treatment eligibility expansion and timely antiretroviral treatment initiation following enrollment in HIV care: A metaregression analysis of programmatic data from 22 countries

PubMed Central

Brazier, Ellen; Yiannoutsos, Constantin; Wools-Kaloustian, Kara; Althoff, Keri; Van Nguyen, Kinh; Sinayobye, Jean d'Amour; Anderegg, Nanina; Ford, Nathan; Wikramanayake, Radhika; Nash, Denis

2018-01-01

Background The effect of antiretroviral treatment (ART) eligibility expansions on patient outcomes, including rates of timely ART initiation among those enrolling in care, has not been assessed on a large scale. In addition, it is not known whether ART eligibility expansions may lead to “crowding out” of sicker patients. Methods and findings We examined changes in timely ART initiation (within 6 months) at the original site of HIV care enrollment after ART eligibility expansions among 284,740 adult ART-naïve patients at 171 International Epidemiology Databases to Evaluate AIDS (IeDEA) network sites in 22 countries where national policies expanding ART eligibility were introduced between 2007 and 2015. Half of the sites included in this analysis were from Southern Africa, one-third were from East Africa, and the remainder were from the Asia-Pacific, Central Africa, North America, and South and Central America regions. The median age of patients enrolling in care at contributing sites was 33.5 years, and the median percentage of female patients at these clinics was 62.5%. We assessed the 6-month cumulative incidence of timely ART initiation (CI-ART) before and after major expansions of ART eligibility (i.e., expansion to treat persons with CD4 ≤ 350 cells/μL [145 sites in 22 countries] and CD4 ≤ 500 cells/μL [152 sites in 15 countries]). Random effects metaregression models were used to estimate absolute changes in CI-ART at each site before and after guideline expansion. The crude pooled estimate of change in CI-ART was 4.3 percentage points (95% confidence interval [CI] 2.6 to 6.1) after ART eligibility expansion to CD4 ≤ 350, from a baseline median CI-ART of 53%; and 15.9 percentage points (pp) (95% CI 14.3 to 17.4) after ART eligibility expansion to CD4 ≤ 500, from a baseline median CI-ART of 57%. The largest increases in CI-ART were observed among those newly eligible for treatment (18.2 pp after expansion to CD4 ≤ 350 and 47.4 pp after expansion to CD4 ≤ 500), with no change or small increases among those eligible under prior guidelines (CD4 ≤ 350: −0.6 pp, 95% CI −2.0 to 0.7 pp; CD4 ≤ 500: 4.9 pp, 95% CI 3.3 to 6.5 pp). For ART eligibility expansion to CD4 ≤ 500, changes in CI-ART were largest among younger patients (16–24 years: 21.5 pp, 95% CI 18.9 to 24.2 pp). Key limitations include the lack of a counterfactual and difficulty accounting for secular outcome trends, due to universal exposure to guideline changes in each country. Conclusions These findings underscore the potential of ART eligibility expansion to improve the timeliness of ART initiation globally, particularly for young adults. PMID:29570723

Poor Accrual in Palliative Research Studies: An Update From the Rapid Response Radiotherapy Program

PubMed Central

Lien, Karen; Zeng, Liang; Bradley, Nicole; Culleton, Shaelyn; Popovic, Marko; Di Giovanni, Julia; Jamani, Rehana; Cramarossa, Gemma; Nguyen, Janet; Koo, Kaitlin; Jon, Florencia; Chow, Edward

2011-01-01

Background In June 2003, the Rapid Response Radiotherapy Program (RRRP) implemented changes to recruitment strategies in attempts to increase patient accrual to research studies. Such modifications included the use of a dedicated research assistant to screen for and identify eligible study patients, the introduction of more appropriate inclusion criteria, and the switch towards telephone interviews to minimize patient burden. The purpose of this study is to provide an update on patient accrual in the RRRP. Methods All patients seen in the RRRP from January 2002 to December 2009 were recorded in a prospective database. Reasons for referral, eligibility for clinical trials, reasons for non-accrual, and various demographics information were recorded. Descriptive statistics summarized findings. Results A total of 4726 patient visits were recorded from January 1st, 2002 to December 31st, 2009. Prior to changes, the overall rate of accrual into research studies was 14.9% versus 48.1% after changes were implemented. Patients were not accrued onto studies mainly to due ineligibility according to study protocol. Other reasons such as language barrier (12.1%), physician objection (3.5%), patient declining participation (11.3%) and lack of a research assistant (9.3%) were cited. Conclusions Changes in clinical structure and study design can significantly impact accrual patterns in palliative radiotherapy studies. Despite these changes however, the majority of patients are still not enrolled in studies. Therefore additional efforts need to be made to maximize patient accrual and minimize attrition. PMID:29147251

Feasibility of feature-based indexing, clustering, and search of clinical trials: A case study of breast cancer trials from ClinicalTrials.gov

PubMed Central

Boland, Mary Regina; Miotto, Riccardo; Gao, Junfeng; Weng, Chunhua

2013-01-01

Summary Background When standard therapies fail, clinical trials provide experimental treatment opportunities for patients with drug-resistant illnesses or terminal diseases. Clinical Trials can also provide free treatment and education for individuals who otherwise may not have access to such care. To find relevant clinical trials, patients often search online; however, they often encounter a significant barrier due to the large number of trials and in-effective indexing methods for reducing the trial search space. Objectives This study explores the feasibility of feature-based indexing, clustering, and search of clinical trials and informs designs to automate these processes. Methods We decomposed 80 randomly selected stage III breast cancer clinical trials into a vector of eligibility features, which were organized into a hierarchy. We clustered trials based on their eligibility feature similarities. In a simulated search process, manually selected features were used to generate specific eligibility questions to filter trials iteratively. Results We extracted 1,437 distinct eligibility features and achieved an inter-rater agreement of 0.73 for feature extraction for 37 frequent features occurring in more than 20 trials. Using all the 1,437 features we stratified the 80 trials into six clusters containing trials recruiting similar patients by patient-characteristic features, five clusters by disease-characteristic features, and two clusters by mixed features. Most of the features were mapped to one or more Unified Medical Language System (UMLS) concepts, demonstrating the utility of named entity recognition prior to mapping with the UMLS for automatic feature extraction. Conclusions It is feasible to develop feature-based indexing and clustering methods for clinical trials to identify trials with similar target populations and to improve trial search efficiency. PMID:23666475

Feasibility of feature-based indexing, clustering, and search of clinical trials. A case study of breast cancer trials from ClinicalTrials.gov.

PubMed

Boland, M R; Miotto, R; Gao, J; Weng, C

2013-01-01

When standard therapies fail, clinical trials provide experimental treatment opportunities for patients with drug-resistant illnesses or terminal diseases. Clinical Trials can also provide free treatment and education for individuals who otherwise may not have access to such care. To find relevant clinical trials, patients often search online; however, they often encounter a significant barrier due to the large number of trials and in-effective indexing methods for reducing the trial search space. This study explores the feasibility of feature-based indexing, clustering, and search of clinical trials and informs designs to automate these processes. We decomposed 80 randomly selected stage III breast cancer clinical trials into a vector of eligibility features, which were organized into a hierarchy. We clustered trials based on their eligibility feature similarities. In a simulated search process, manually selected features were used to generate specific eligibility questions to filter trials iteratively. We extracted 1,437 distinct eligibility features and achieved an inter-rater agreement of 0.73 for feature extraction for 37 frequent features occurring in more than 20 trials. Using all the 1,437 features we stratified the 80 trials into six clusters containing trials recruiting similar patients by patient-characteristic features, five clusters by disease-characteristic features, and two clusters by mixed features. Most of the features were mapped to one or more Unified Medical Language System (UMLS) concepts, demonstrating the utility of named entity recognition prior to mapping with the UMLS for automatic feature extraction. It is feasible to develop feature-based indexing and clustering methods for clinical trials to identify trials with similar target populations and to improve trial search efficiency.

Experiences of recruiting to a pilot trial of Cardiac Rehabilitation In patients with Bowel cancer (CRIB) with an embedded process evaluation: lessons learned to improve recruitment.

PubMed

Hubbard, Gill; Campbell, Anna; Davies, Zoe; Munro, Julie; Ireland, Aileen V; Leslie, Stephen; Watson, Angus Jm; Treweek, Shaun

2015-01-01

Recruitment to randomised controlled trials (RCTs) is a perennial problem. Calls have been made for trialists to make recruitment performance publicly available. This article presents our experience of recruiting to a pilot RCT of cardiac rehabilitation for patients with bowel cancer with an embedded process evaluation. Recruitment took place at three UK hospitals. Recruitment figures were based on the following: i) estimated number of patient admissions, ii) number of patients likely to meet inclusion criteria from clinician input and iii) recruitment rates in previous studies. The following recruitment procedure was used:Nurse assessed patients for eligibility.Patients signed a screening form indicating interest in and agreement to be approached by a researcher about the study.An appointment was made at which the patient signed a consent form and was randomised to the intervention or control group. Information about all patients considered for the study and subsequently included or excluded at each stage of the recruitment process and reasons given were recorded. There were variations in the time taken to award Research Management approval to run the study at the three sites (45-359 days). Sixty-two percent of the original recruitment estimate was reached. The main reason for under-recruitment was due to over-estimation of the number of patient admissions; other reasons were i) not assessing all patients for eligibility, ii) not completing a screening form for eligible patients and iii) patients who signed a screening form being lost to the study before consenting and randomisation. Pilot trials should not simply aim to improve recruitment estimates but should also identify factors likely to influence recruitment performance in a future trial and inform the development of that trial's recruitment strategies. Pilot trials are a crucial part of RCT design. Nevertheless, pilot trials are likely to be small scale, involving only a small number of sites, and contextual differences between sites are likely to impact recruitment performance in any future trial. This means that ongoing monitoring and evaluation in trials are likely to be required. ISRCTN63510637; UKCRN id 14092.

Association of patient case-mix adjustment, hospital process performance rankings, and eligibility for financial incentives.

PubMed

Mehta, Rajendra H; Liang, Li; Karve, Amrita M; Hernandez, Adrian F; Rumsfeld, John S; Fonarow, Gregg C; Peterson, Eric D

2008-10-22

While most comparisons of hospital outcomes adjust for patient characteristics, process performance comparisons typically do not. To evaluate the degree to which hospital process performance ratings and eligibility for financial incentives are altered after accounting for hospitals' patient demographics, clinical characteristics, and mix of treatment opportunities. Using data from the American Heart Association's Get With the Guidelines program between January 2, 2000, and March 28, 2008, we analyzed hospital process performance based on the Centers for Medicare & Medicaid Services' defined core measures for acute myocardial infarction. Hospitals were initially ranked based on crude composite process performance and then ranked again after accounting for hospitals' patient demographics, clinical characteristics, and eligibility for measures using a hierarchical model. We then compared differences in hospital performance rankings and pay-for-performance financial incentive categories (top 20%, middle 60%, and bottom 20% institutions). Hospital process performance ranking and pay-for-performance financial incentive categories. A total of 148,472 acute myocardial infarction patients met the study criteria from 449 centers. Hospitals for which crude composite acute myocardial infarction performance was in the bottom quintile (n = 89) were smaller nonacademic institutions that treated a higher percentage of patients from racial or ethnic minority groups and also patients with greater comorbidities than hospitals ranked in the top quintile (n = 90). Although there was overall agreement on hospital rankings based on observed vs adjusted composite scores (weighted kappa, 0.74), individual hospital ranking changed with adjustment (median, 22 ranks; range, 0-214; interquartile range, 9-40). Additionally, 16.5% of institutions (n = 74) changed pay-for-performance financial status categories after accounting for patient and treatment opportunity mix. Our findings suggest that accounting for hospital differences in patient characteristics and treatment opportunities is associated with modest changes in hospital performance rankings and eligibility for financial benefits in pay-for-performance programs for treatment of myocardial infarction.

Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

DOE Office of Scientific and Technical Information (OSTI.GOV)

Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing

Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials inmore » NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.« less

Clinical Utility of Serologic Testing for Celiac Disease in Asymptomatic Patients

PubMed Central

2011-01-01

Executive Summary Objective The objective of this evidence-based analysis was to evaluate the clinical utility of serologic testing for celiac disease in asymptomatic individuals presenting with one of the non-gastrointestinal conditions evaluated in this report. The clinical utility was based on the effects of a gluten-free diet (GFD) on outcomes specific to each of these conditions. The prevalence of celiac disease in asymptomatic individuals and one of these non-gastrointestinal conditions was also evaluated. Clinical Need and Target Population Celiac Disease Celiac disease is an autoimmune disease characterized by a chronic inflammatory state of the proximal small bowel mucosa accompanied by structural and functional changes. Technology Under Evaluation Serologic Tests for Celiac Disease There are a number of serologic tests for celiac disease available. Serologic tests are automated with the exception of the anti-endomysial antibody test, which is more time-consuming and operator-dependent than the other tests. Research Questions What is the prevalence of asymptomatic celiac disease in patients presenting with one of the non-gastrointestinal conditions evaluated? What is the effect of the gluten-free diet on condition-specific outcomes in patients with asymptomatic celiac disease presenting with one of the non-gastrointestinal conditions evaluated? What is the clinical utility of serologic testing for celiac disease in asymptomatic patients presenting with one of the non-gastrointestinal conditions evaluated? The clinical utility was defined as the impact of the GFD on disease specific outcomes. What is the risk of all-cause mortality and lymphoma in individuals with asymptomatic celiac disease? What is the budget impact of serologic testing for celiac disease in asymptomatic subjects presenting with one of the non-gastrointestinal conditions evaluated? Research Methods Study Population The study population consisted of individuals with newly diagnosed celiac disease without any symptoms consistent with the disease presenting with one of the non-gastrointestinal conditions evaluated. When evaluating the risk of lymphoma and all-cause mortality, the study population consisted of asymptomatic individuals with a positive celiac disease serologic test and/or small bowel biopsy. Literature Search Search Strategy Literature searches were performed for each disease/condition evaluated between December 2010 and March 2011 using OVID MEDLINE, the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA). No restrictions for start date of search were used. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. Articles with an unknown eligibility were reviewed with a second clinical epidemiologist and then a group of epidemiologists until consensus was established. Inclusion Criteria Studies, systematic reviews, and meta-analyses that assessed the effects of a GFD in patients with newly diagnosed asymptomatic celiac disease presenting with one of the non-gastrointestinal conditions evaluated. If symptoms were not reported in the study but subjects were identified through screening for celiac disease the study was included. Studies, systematic reviews, and meta-analyses that assessed the prevalence of newly diagnosed asymptomatic celiac disease in patients with one of the non-gastrointestinal conditions evaluated. If symptoms were not reported in the study but subjects were identified through screening for celiac disease the study was included. Studies, systematic reviews, and meta-analyses that evaluated the risk of all-cause mortality or lymphoma in individuals with asymptomatic celiac disease. Sample size ≥ 10. Publications in English. Exclusion Criteria Studies that retrospectively assessed the prevalence of asymptomatic celiac disease. Studies that reported the prevalence of one of the non-gastrointestinal conditions evaluated in subjects already diagnosed with celiac disease. Studies in individuals with one of the non-gastrointestinal conditions evaluated if the condition could be explained by other causes. Studies in subjects with celiac disease and symptoms consistent with the disease. If the study included individuals with and without symptoms consistent with celiac disease and their results were analysed separately, the results in individuals without symptoms were included in the analysis. Studies in which individuals did not report any symptoms consistent with celiac disease at study start but that either retrospectively reported the presence of such symptoms after following a GFD, or that previously presented with symptoms consistent with celiac disease. Study results published in letters to the editor or comments about other studies. Studies with a sample size ≥ 10, however, in which less than 10 patients were included in the analysis. Outcomes of Interest The effects of a GFD on disease-specific outcomes for each condition evaluated in patients with asymptomatic celiac disease was assessed. The prevalence of asymptomatic celiac disease in patients presenting with one of the conditions evaluated was also assessed. Results of Evidence-Based Analysis Three eligible observational studies evaluated the effects of GFD on growth parameters in subjects with asymptomatic celiac disease and idiopathic short stature. Four eligible observational studies evaluated the effects of GFD on metabolic control in subjects with asymptomatic celiac disease and type 1 diabetes. Five eligible observational studies evaluated the risk of all-cause mortality and five eligible observational studies evaluated the risk of lymphoma in subjects with asymptomatic celiac disease. No eligible studies on the effects of the GFD for the other conditions evaluated were identified. Twenty-three eligible studies measured the prevalence of asymptomatic celiac disease in subjects presenting with one of the conditions evaluated. Prevalence of Celiac Disease in Asymptomatic Patients The prevalence of celiac disease in asymptomatic patients presenting with one of the conditions evaluated was analysed. Most studies also included a control group that generally consisted of individuals randomly selected from the general population. Although there was a trend to a higher prevalence of asymptomatic celiac disease in individuals with the conditions evaluated compared to the controls, it only reached statistical significance in type 1 diabetes. No eligible prevalence studies were identified in patients with amenorrhea, delayed puberty, alopecia, and depression. The Effects of a Gluten-Free Diet on Disease-Specific Outcomes in Patients with Asymptomatic Celiac Disease The effects of GFD on metabolic control in patients with asymptomatic celiac disease and Type 1 Diabetes The effects of a GFD on metabolic control (HbA1c, number of hypoglycemic episodes, and changes in insulin dosage) in subjects with asymptomatic celiac disease and type 1 diabetes were evaluated. One prospective case-control study reported an increase in HbA1c levels in cases with type 1 diabetes and asymptomatic celiac disease after the introduction of a GFD, however, the clinical significance of this change is unclear. Only one eligible retrospective case-control study evaluated the effects of a GFD on hypoglycemia episodes and since there were inadequate details in the study about both the ascertainment and severity of hypoglycemia episodes in both cases and controls, it is not possible to draw conclusions regarding the effects of a GFD on hypoglycemia episodes based on this study. One prospective case-control study did not show a statistically significant change in insulin dosage between cases with type 1 diabetes and asymptomatic celiac disease and controls with type 1 diabetes either before or after the introduction of a GFD. No eligible studies that evaluated the effects of a GFD on the long-term outcomes of type 1 diabetes such as cardiovascular or renal events in patients with asymptomatic celiac disease were identified. The effects of a Gluten-Free Diet in Patients with Idiopathic Short Stature and Asymptomatic Celiac Disease A total of 3 eligible studies were identified. All studies consisted of case series that compared growth parameters in subjects with asymptomatic celiac disease and idiopathic short stature before and after the celiac disease was diagnosed and the GFD was instituted. Most subjects included in the studies demonstrated an improvement in growth parameters. Compliance with the GFD was not reported in the studies. The results of the studies suggest an increase in growth velocity in pediatric patients with asymptomatic celiac disease and idiopathic short stature once a GFD is introduced. Risk of lymphoma in patients with asymptomatic celiac disease One retrospective cohort study evaluated the risk of lymphoma in patients with asymptomatic celiac disease. The authors concluded that the number of events identified was low during the long follow-up period and that the risk of overall malignancies was not increased among patients with asymptomatic celiac disease. Risk of Asymptomatic Celiac Disease in Patients with Lymphoma Four case-control studies, one of which retrospective, evaluated the risk of asymptomatic celiac disease in patients newly diagnosed with lymphoma. One retrospective cohort study did not show an increase in the risk of lymphoma among subjects with asymptomatic celiac disease. Three prospective case-control studies did not find a statistically significant risk of asymptomatic celiac disease in patients with newly diagnosed lymphoma. Risk of All-Cause Mortality in Patients with Asymptomatic Celiac Disease A total of 5 studies that evaluated the risk of all-cause mortality in asymptomatic patients with celiac disease were identified. There were 5 cohort studies, 2 prospective and 3 retrospective. The two prospective studies did not show an increased risk of all-cause mortality in subjects with asymptomatic celiac disease. Grading of Evidence The quality of the evidence for each serologic tests evaluated based on the GRADE Working Group criteria. Overall, the quality of the evidence ranged from low to very low depending on the outcome evaluated. The Clinical Utility of Serologic Testing for Celiac Disease in Asymptomatic Subjects Eligible studies that evaluated the effects of a GFD on disease-specific outcomes were only identified for two of the conditions evaluated, type 1 diabetes and idiopathic short stature. The clinical utility of serologic testing for celiac disease in patients with type 1 diabetes without symptoms consistent with celiac disease was not demonstrated since the studies identified did not provide evidence of the impact of the GFD on either metabolic control or long-term outcomes in these patients. The clinical utility of serologic testing for celiac disease in patients with idiopathic short stature without symptoms consistent with celiac disease was demonstrated since the studies identified showed an acceleration in growth once the diagnosis of celiac disease was made and a GFD was introduced. The Budget Impact of Serologic Testing for Celiac Disease in Asymptomatic Patients The budget impact of serologic testing for celiac disease in asymptomatic patients was calculated for the conditions for which clinical utility for serologic testing was demonstrated. The budget impact in patients with idiopathic short stature without symptoms consistent with celiac disease was estimated as C$552,000 as calculated by multiplying the number of individuals in Ontario with idiopathic short stature that may be eligible for the test by the cost of the serologic test for celiac disease. Conclusions Based on a review of the literature, there is an increased risk of asymptomatic celiac disease in patients with type 1 diabetes. Based on low quality evidence, in patients with idiopathic short stature and asymptomatic celiac disease there is an acceleration in growth once a gluten-free diet is introduced. With the exception of idiopathic short stature, there was no published evidence of clinical utility of celiac disease testing in asymptomatic patients with respect to a gluten-free diet intervention in the other conditions evaluated. Based on low to very low quality evidence, asymptomatic celiac disease does not confer an increased risk of lymphoma or mortality. Similarly, in patients with lymphoma there is no increased risk of asymptomatic celiac disease. PMID:23074415

Insertable cardiac event recorder in detection of atrial fibrillation after cryptogenic stroke: an audit report.

PubMed

Etgen, Thorleif; Hochreiter, Manfred; Mundel, Markus; Freudenberger, Thomas

2013-07-01

Atrial fibrillation (AF) is the most frequent risk factor in ischemic stroke but often remains undetected. We analyzed the value of insertable cardiac event recorder in detection of AF in a 1-year cohort of patients with cryptogenic ischemic stroke. All patients with cryptogenic stroke and eligibility for oral anticoagulation were offered the insertion of a cardiac event recorder. Regular follow-up for 1 year recorded the incidence of AF. Of the 393 patients with ischemic stroke, 65 (16.5%) had a cryptogenic stroke, and in 22 eligible patients, an event recorder was inserted. After 1 year, in 6 of 22 patients (27.3%), AF was detected. These preliminary data show that insertion of cardiac event recorder was eligible in approximately one third of patients with cryptogenic stroke and detected in approximately one quarter of these patients new AF.

Patient Satisfaction Survey 1989-1990

DTIC Science & Technology

1990-07-01

Health Association of America (GHAA) Consumer Satisfaction Survey. Patient Satisfaction Surveys were mailed to 9,000 eligible beneficiaries at 37 Army...SATISFACTION SURVEY Background The patient satisfaction survey tasking came from Headquarters, Health Services Command requesting the GHAA Consumer ...UNITED STATES ARMY HEALTH CARE STUDIES AND CLINICAL INVESTIGATION ACTIVITY /TiC Ii PATIENT SATISFACTION SURVEY 1989-1990 (V) !EXECUTIVE SUMMARY o A

Lessons from Prenatal Care Provider-Based Recruitment into the National Children’s Study

PubMed Central

Robbins, James M.; Bridges, Melissa D.; Childers, Elizabeth M.; Harris, Roseanne M.; McElfish, Pearl A.

2015-01-01

In response to recruitment difficulties experienced by the National Children’s Study, alternatives to the door-to-door recruitment method were pilot tested. This report describes outcomes, successes, and challenges of recruiting women through prenatal care providers in Benton County, Arkansas, USA. Eligible women residing in 14 randomly selected geographic segments were recruited. Data were collected during pregnancy, at birth, and at 3, 6, 9, 12, 18, and 24 months postpartum. Participants were compared to non-enrolled eligible women through birth records. Of 6402 attempts to screen for address eligibility, 468 patients were potentially eligible. Of 221 eligible women approached to participate, 151 (68%) enrolled in the 21-year study. Enrolled women were similar to non-enrolled women in age, marital status, number of prenatal care visits, and gestational age and birth weight of the newborn. Women enrolled from public clinics were more likely to be Hispanic, lower educated, younger and unmarried than those enrolled from private clinics. Sampling geographic areas from historical birth records failed to produce expected equivalent number of births across segments. Enrollment of pregnant women from prenatal care providers was successful. PMID:26500750

Effect of nebulized budesonide on decreasing the recurrence of allergic fungal rhinosinusitis.

PubMed

Dai, Qi; Duan, Chen; Liu, Quan; Yu, Hongmeng

The aim of this study was to evaluate the clinical efficacy and the effects on decreasing the recurrence of AFRS (allergic fungal rhinosinusitis) of a budesonide inhalation suspension delivered via transnasal nebulization to patients following endoscopic sinus surgery. Thirty-five patients were recruited into this study. Final diagnoses were reached using Bent and Kuhn's criteria. The eligible patients were randomly divided into two groups: the budesonide transnasal nebulization group (group A) and the topical nasal steroids group (group B). Nasal symptoms, Lund-Mackay scores, and Kupferberg grades were evaluated before surgery, after surgery and during the follow-up to assess the effects of these two approaches. A total of 30 patients with AFRS who were eligible were included in the study. Four of the 15 patients in group B (26.67%) developed recurrent disease, whereas no patients in group A developed recurrent disease. This difference was statistically significant (p=0.032). Nebulized budesonide is an effective and safe treatment for patients with AFRS following endoscopic sinus surgery, as evidenced by the reduced recurrence rate observed in the budesonide transnasal nebulization group relative to the topical nasal steroids group. Copyright © 2017 Elsevier Inc. All rights reserved.

Glad you brought it up: a patient-centred programme to reduce proton-pump inhibitor prescribing in general medical practice.

PubMed

Murie, Jill; Allen, Jane; Simmonds, Ray; de Wet, Carl

2012-01-01

Many patients unnecessarily receive proton-pump inhibitor (PPI) drugs long term with significant financial and safety implications. Educating, empowering and supporting patients to self-manage their symptoms can lead to significant and sustained reductions in PPI prescribing. We aimed to implement a programme to reduce inappropriate PPI prescribing. Eligible patients in one general medical practice in rural Scotland were invited for participation between November 2008 and February 2010. Patients attended special nurse advisor clinics, completed dyspepsia questionnaires, received information, formulated self-management plans and were offered flexible support. Of the study population, 437/2883 (15%) were prescribed PPIs. Of these, 166 (38%) were judged eligible for participation. After 12 months, 138/157 (83%) had reduced or stopped their PPIs, while 19/157 (11%) had reverted. The estimated annual net saving in the prescribing budget was ?3180.67. Self-reported understanding of symptom self-management increased from 6/20 (30%) to 18/20 (90%) patients after participation in the programme. A patient-centred programme delivered by a specialist nurse significantly reduced PPI prescribing with financial and potential therapeutic benefits. The vast majority of eligible patients were able to 'step down and off' or 'step off' PPI use after 12 months without any complications or deteriorating symptom control. Further research with larger cohorts of practices and patients is needed to develop a feasible, acceptable and effective programme if similar benefits are to be achieved for primary care in general.

A prospective randomized study of use of drain versus no drain after burr-hole evacuation of chronic subdural hematoma.

PubMed

Singh, Amit Kumar; Suryanarayanan, Bhaskar; Choudhary, Ajay; Prasad, Akhila; Singh, Sachin; Gupta, Laxmi Narayan

2014-01-01

Chronic subdural hematoma (CSDH) recurs after surgical evacuation in 5-30% of patients. Inserting subdural drain might reduce the recurrence rate, but is not commonly practiced. There are few prospective studies to evaluate the effect of subdural drains. A prospective randomized study to investigate the effect of subdural drains in the on recurrence rates and clinical outcome following burr-hole drainage (BHD) of CSDH was undertaken. During the study period, 246 patients with CSDH were assessed for eligibility. Among 200 patients fulfilling the eligibility criteria, 100 each were assigned to "drain group" (drain inserted into the subdural space following BHD) and "without drain group" (subdural drain was not inserted following BHD) using random allocation software. The primary end point was recurrence needing re-drainage up to a period of 6 months from surgery. Recurrence occurred in 9 of 100 patients with a drain, and 26 of 100 patients in without drain group (P = 0.002). The mortality was 5% in patients with drain and 4% in patients without drain group (P = 0.744). The medical and surgical complications were comparable between the two study groups. Use of a subdural drain after burr-hole evacuation of a CSDH reduces the recurrence rate and is not associated with increased complications.

Preferred Place of Care and Death in Terminally Ill Patients with Lung and Heart Disease Compared to Cancer Patients.

PubMed

Skorstengaard, Marianne H; Neergaard, Mette A; Andreassen, Pernille; Brogaard, Trine; Bendstrup, Elisabeth; Løkke, Anders; Aagaard, Susanne; Wiggers, Henrik; Bech, Per; Jensen, Anders B

2017-11-01

The dual aim of this study is, first, to describe preferred place of care (PPOC) and preferred place of death (PPOD) in terminally ill patients with lung and heart diseases compared with cancer patients and second, to describe differences in level of anxiety among patients with these diagnoses. Previous research on end-of-life preferences focuses on cancer patients, most of whom identify home as their PPOC and PPOD. These preferences may, however, not mirror those of patients suffering from nonmalignant fatal diseases. The study was designed as a cross-sectional study. Eligible patients from the recruiting departments filled in questionnaires regarding sociodemographics, PPOC and PPOD, and level of anxiety. Of the 354 eligible patients, 167 patients agreed to participate in the study. Regardless of their diagnosis, most patients wished to be cared for and to die at home. Patients with cancer and heart diseases chose hospice as their second most common preference for both PPOC and PPOD, whereas patients with lung diseases chose nursing home and hospice equally frequent as their second most common preference. Regardless of their diagnosis, all patients had a higher level of anxiety than the average Danish population; patients with heart diseases had a much higher level of anxiety than patients with lung diseases and cancer. Patient preferences for PPOC and PPOD vary according to their diagnoses; tailoring palliative needs to patients' preferences is important regardless of their diagnosis.

A Patient Learning Center for an Army MEDDAC - A Feasibility Study. Final Report.

ERIC Educational Resources Information Center

Kucha, Deloros H.

A feasibility study was conducted to examine in detail, analyze, and describe the development and operation (system effectiveness and efficiency) of a patient learning center in a MEDDAC, and to provide such information to the Surgeon General for use in planning future health care delivery to military-care eligible beneficiaries. Study objectives…

Limited responsiveness related to the minimal important difference of patient-reported outcomes in rare diseases.

PubMed

Johnston, Bradley C; Miller, Patricia A; Agarwal, Arnav; Mulla, Sohail; Khokhar, Rabia; De Oliveira, Kyle; Hitchcock, Christine L; Sadeghirad, Behnam; Mohiuddin, Mukarram; Sekercioglu, Nigar; Seweryn, Michal; Koperny, Magdalena; Bala, Malgorzata M; Adams-Webber, Thomasin; Granados, Alicia; Hamed, Alaa; Crawford, Mark W; van der Ploeg, Ans T; Guyatt, Gordon H

2016-11-01

To explore the responsiveness of patient-reported outcomes (PROs) in interventional studies involving patients with rare lysosomal storage diseases (LSDs). We searched eight databases for experimental and nonexperimental studies. Pairs of trained reviewers independently screened articles and subsequently extracted data from the eligible studies. Among studies with 10 or more patients using a valid PRO, we assessed the responsiveness of PROs based on a reanalysis of the data using minimal important difference estimates. Our analyses focused on statistically significant within-group differences in PROs for observational studies or the statistically significant between-group differences in PRO scores for controlled studies. Of 2,679 unique records, 62 interventional studies addressing patients with Fabry (55%), Gaucher (19%), Pompe (16%), and mucopolysaccharidoses (11%) proved eligible. The most frequently used PROs were the Short-Form-36 (25 studies), Brief Pain Inventory (20 studies), EuroQoL-5D (9 studies), and the Fatigue Severity Scale (6 studies). Observational studies suggest that PROs sometimes detect significant within-group changes when present. Randomized trials raise questions regarding the responsiveness of PROs to small differences between groups. Most studies have relied on generic PROs to evaluate quality of life and symptoms in patients with rare LSDs. PROs appear more responsive in observational studies than randomized trials. Copyright © 2016 Elsevier Inc. All rights reserved.

Characterization of patients with diabetic foot disease presenting to an Irish Podiatry Centre: profiling suitability for entry to a clinical trial of advanced wound therapeutics.

PubMed

Mahon, A M; MacGilchrist, C; McIntosh, C; O'Brien, T

2017-08-01

Diabetes mellitus, coined the 'Black Death of the Twenty-First Century', is associated with complications, including foot ulceration with potential loss of limb. There is a need for development of new wound therapies through completion of robust clinical trials. To profile demographics and wound characteristics of an Irish cohort with diabetes, forecast eligibility for entry to a clinical trial of advanced wound therapeutics, and adjust criteria to optimize eligibility for enrolment. A cross-sectional study of out-patients attending a Podiatry centre over 12 weeks was conducted. Information was collected through clinical assessment, including Neuropathy Disability Score and Ankle-Brachial Pressure Index. Ulcers were characterised as 'healing' or 'non-healing'; a 'healing' wound decreased by 30 % over the previous month, accomplished by retrospective analysis of files. Statistics, including binomial logistic regression and column analysis for eligibility assessment, were conducted. Seventy-four participants were identified with a mean age of 67 (± 8.79) years. Non-healing DFU status correlated significantly with larger wound area (P = 0.013), infection (P = 0.009), and greater degrees of ischaemia (P = 0.015). The eligibility criteria were modelled after those proposed by the EU consortium project REDDSTAR. In this Irish population, these criteria limit eligibility to 1.4 %. This research found an eligibility criterion of wound area 2-10 cm 2 for enrolment in a clinical trial of mesenchymal stromal cell therapy too restrictive. Extension of wound area to 1-10 cm 2 and the inclusion of neuro-ischaemic ulcers increased eligibility for enrolment from 1.4 to 20 %.

An Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective Randomized Control Trials

PubMed Central

Logan, Jennifer K; Tang, Chad; Liao, Zhongxing; Lee, J. Jack; Heymach, John V.; Swisher, Stephen G.; Welsh, James W.; Zhang, Jianjun; Lin, Steven H.; Gomez, Daniel R.

2018-01-01

Purpose Effective clinical trial enrollment can be difficult in a protocol designs that contain one treatment arm that is perceived as being more “aggressive” or “favorable.” There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to enrollment, particularly the influence of timing, in context of three prospective randomized oncology trials where one arm was considered more aggressive. Methods and materials From June 2011 to March 2015, patients who were enrolled on three prospective institutional protocols (an oligometastatic non-small cell lung cancer (NSCLC) trial, and two proton vs. intensity-modulated radiation therapy (IMRT) trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher’s exact test, Student’s t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results 309 eligible patients were approached about trial enrollment. The enrollment success rate (ESR) during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligomet protocol: 5 vs. 3 appointments (P<0.001), NSCLC protocol: 4 vs. 3 appointments (P = 0.0018), esophageal protocol: 3 vs. 2 appointments (P = 0.0086No other factors or patient characteristics significantly affected ESR. Conclusion Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success, and may help overcome accrual barriers without compromising trial design. PMID:28244413

Impact of Modality Choice on Rates of Hospitalization in Patients Eligible for Both Peritoneal Dialysis and Hemodialysis

PubMed Central

Quinn, Robert R.; Ravani, Pietro; Zhang, Xin; Garg, Amit X.; Blake, Peter G.; Austin, Peter C.; Zacharias, James M.; Johnson, John F.; Pandeya, Sanjay; Verrelli, Mauro; Oliver, Matthew J.

2014-01-01

♦ Background: Hospitalization rates are a relevant consideration when choosing or recommending a dialysis modality. Previous comparisons of peritoneal dialysis (PD) and hemodialysis (HD) have not been restricted to individuals who were eligible for both therapies. ♦ Methods: We conducted a multicenter prospective cohort study of people 18 years of age and older who were eligible for both PD and HD, and who started outpatient dialysis between 2007 and 2010 in four Canadian dialysis programs. Zero-inflated negative binomial models, adjusted for baseline patient characteristics, were used to examine the association between modality choice and rates of hospitalization. ♦ Results: The study enrolled 314 patients. A trend in the HD group toward higher rates of hospitalization, observed in the primary analysis, became significant when modality was treated as a time-varying exposure or when the population was restricted to elective outpatient starts in patients with at least 4 months of pre-dialysis care. Cardiovascular disease, infectious complications, and elective surgery were the most common reasons for hospital admission; only 23% of hospital stays were directly related to complications of dialysis or kidney disease. ♦ Conclusions: Efforts to promote PD utilization are unlikely to result in increased rates of hospitalization, and efforts to reduce hospital admissions should focus on potentially avoidable causes of cardiovascular disease and infectious complications. PMID:24525596

Stroke Treatment Academic Industry Roundtable

PubMed Central

Jovin, Tudor G.; Albers, Gregory W.; Liebeskind, David S.

2017-01-01

Background and Purpose The STAIR (Stroke Treatment Academic Industry Roundtable) meeting aims to advance acute stroke therapy development through collaboration between academia, industry, and regulatory institutions. In pursuit of this goal and building on recently available level I evidence of benefit from endovascular therapy (ET) in large vessel occlusion stroke, STAIR IX consensus recommendations were developed that outline priorities for future research in ET. Methods Three key directions for advancing the field were identified: (1) development of systems of care for ET in large vessel occlusion stroke, (2) development of therapeutic approaches adjunctive to ET, and (3) exploring clinical benefit of ET in patient population insufficiently studied in recent trials. Methodological issues such as optimal trial design and outcome measures have also been addressed. Results Development of systems of care strategies should be geared both toward ensuring broad access to ET for eligible patients and toward shortening time to reperfusion to the minimum possible. Adjunctive therapy development includes neuroprotective approaches, adjuvant microcirculatory/collateral enhancing strategies, and periprocedural management. Future research priorities seeking to expand the eligible patient population are to determine benefit of ET in patients presenting beyond conventional time windows, in patients with large baseline ischemic core lesions, and in other important subgroups. Conclusions Research priorities in ET for large vessel occlusion stroke are to improve systems of care, investigate effective adjuvant therapies, and explore whether patient eligibility could be expanded. PMID:27586682

Is unhealthy substance use associated with failure to receive cancer screening and flu vaccination? A retrospective cross-sectional study

PubMed Central

Kim, Theresa W; Alford, Daniel P; Cabral, Howard; Saitz, Richard; Samet, Jeffrey H

2011-01-01

Objective To compare cancer screening and flu vaccination among persons with and without unhealthy substance use. Design The authors analysed data from 4804 women eligible for mammograms, 4414 eligible for Papanicolou (Pap) smears, 7008 persons eligible for colorectal cancer (CRC) screening and 7017 persons eligible for flu vaccination. All patients were screened for unhealthy substance use. The main outcome was completion of cancer screening and flu vaccination. Results Among the 9995 patients eligible for one or more of the preventive services of interest, 10% screened positive for unhealthy substance use. Compared with women without unhealthy substance use, women with unhealthy substance use received mammograms less frequently (75.4% vs 83.8%; p<0.0001), but Pap smears no less frequently (77.9% vs 78.1%). Persons with unhealthy substance use received CRC screening no less frequently (61.7% vs 63.4%), yet received flu vaccination less frequently (44.7% vs 50.4%; p=0.01). In multivariable analyses, women with unhealthy substance use were less likely to receive mammograms (adjusted odds ratio 0.68; 95% CI 0.52 to 0.89), and persons with unhealthy substance use were less likely to receive flu vaccination (adjusted odds ratio 0.81; 95% CI 0.67 to 0.97). Conclusions Unhealthy substance use is a risk factor for not receiving all appropriate preventive health services. PMID:22021737

"It's easier in pharmacy": why some patients prefer to pay for flu jabs rather than use the National Health Service.

PubMed

Anderson, Claire; Thornley, Tracey

2014-01-24

There is a need to increase flu vaccination rates in England particularly among those under 65 years of age and at risk because of other conditions and treatments. Patients in at risk groups are eligible for free vaccination on the National Health Service (NHS) in England, but despite this, some choose to pay privately. This paper explores how prevalent this is and why people choose to do it. There is moderate to good evidence from several countries that community pharmacies can safely provide a range of vaccinations, largely seasonal influenza Immunisation. Pharmacy-based services can extend the reach of immunisation programmes. User, doctor and pharmacist satisfaction with these services is high. Data were collected during the 2012-13 flu season as part of a community pharmacy private flu vaccination service to help identify whether patients were eligible to have their vaccination free of charge on the NHS. Additional data were collected from a sample of patients accessing the private service within 13 pharmacies to help identify the reasons patients paid when they were eligible for free vaccination. Data were captured from 89,011 privately paying patients across 479 pharmacies in England, of whom 6% were eligible to get the vaccination free. 921 patients completed a survey in the 13 pharmacies selected. Of these, 199 (22%) were eligible to get their flu vaccination for free. 131 (66%) were female. Average age was 54 years. Of the 199 patients who were eligible for free treatment, 100 (50%) had been contacted by their GP surgery to go for their vaccination, but had chosen not to go. Reasons given include accessibility, convenience and preference for pharmacy environment. While people at risk can access flu vaccinations free via the NHS, some choose to pay privately because they perceive that community pharmacy access is easier. There are opportunities for pharmacy to support the NHS in delivering free flu vaccinations to patients at risk by targeting people unlikely to access the service at GP surgeries.

Use of health plan combined with registry data to predict clinical trial recruitment.

PubMed

Curtis, Jeffrey R; Wright, Nicole C; Xie, Fenglong; Chen, Lang; Zhang, Jie; Saag, Kenneth G; Bharat, Aseem; Kremer, Joel; Cofield, Stacey; Winthrop, Kevin; Delzell, Elizabeth

2014-02-01

Large pragmatic clinical trials (PCTs) are increasingly used to conduct comparative effectiveness research. In the context of planning a safety PCT of the live herpes zoster vaccine in rheumatoid arthritis (RA) patients aged ≥ 50 years receiving anti-tumor necrosis factor (TNF) therapy, we evaluated the use of health plan combined with registry data to assess the feasibility of recruiting the 4000 patients needed for the trial and to facilitate site selection. Using national US data from Medicare, we identified older RA patients who received anti-TNF therapy in the last quarter of 2009. Extrapolations were made from the Medicare patient population to younger patients and those with other types of insurance using the Consortium of Rheumatology Researchers of North America (CORRONA) disease registry. Patients' treating rheumatologists were grouped into practices and sorted by size from the greatest to the least number of eligible patients. Approximately 50,000 RA patients receiving anti-TNF therapy were identified in the Medicare data, distributed across 1980 physician practices. After augmenting Medicare data with information from CORRONA and extrapolating to younger patients and those with other types of insurance, more than 12,000 potentially eligible study subjects were identified from the 50 largest rheumatology practices. Health plan and registry databases appear useful to assess feasibility of large pragmatic trials and to assist in selection of recruitment sites with the greatest number of potentially eligible patients. This novel approach is applicable to trials with simple inclusion/exclusion criteria that can be readily assessed in these data sources.

Chronic obstructive pulmonary disease self-management activation research trial (COPD-SMART): results of recruitment and baseline patient characteristics.

PubMed

Russo, Rennie; Coultas, David; Ashmore, Jamile; Peoples, Jennifer; Sloan, John; Jackson, Bradford E; Uhm, Minyong; Singh, Karan P; Blair, Steven N; Bae, Sejong

2015-03-01

To describe the recruitment methods, study participation rate, and baseline characteristics of a representative sample of outpatients with COPD eligible for pulmonary rehabilitation participating in a trial of a lifestyle behavioral intervention to increase physical activity. A patient registry was developed for recruitment using an administrative database from primary care and specialty clinics of an academic medical center in northeast Texas for a parallel group randomized trial. The registry was comprised of 5582 patients and over the course of the 30 month recruitment period 325 patients were enrolled for an overall study participation rate of 35.1%. After a 6-week COPD self-management education period provided to all enrolled patients, 305 patients were randomized into either usual care (UC; n=156) or the physical activity self-management intervention (PASM; n=149). There were no clinically significant differences in demographics, clinical characteristics, or health status indicators between the randomized groups. The results of this recruitment process demonstrate the successful use of a patient registry for enrolling a representative sample of outpatients eligible for pulmonary rehabilitation with COPD from primary and specialty care. Moreover, this approach to patient recruitment provides a model for future studies utilizing administrative databases and electronic health records. Published by Elsevier Inc.

Zero end-digit preference in recorded blood pressure and its impact on classification of patients for pharmacologic management in primary care - PREDICT-CVD-6.

PubMed

Broad, Joanna; Wells, Sue; Marshall, Roger; Jackson, Rod

2007-11-01

Most blood pressure recordings end with a zero end-digit despite guidelines recommending measurement to the nearest 2 mmHg. The impact of rounding on management of cardiovascular disease (CVD) risk is unknown. To document the use of rounding to zero end-digit and assess its potential impact on eligibility for pharmacologic management of CVD risk. Cross-sectional study. A total of 23,676 patients having opportunistic CVD risk assessment in primary care practices in New Zealand. To simulate rounding in practice, for patients with systolic blood pressures recorded without a zero end-digit, a second blood pressure measure was generated by arithmetically rounding to the nearest zero end-digit. A 10-year Framingham CVD risk score was estimated using actual and rounded blood pressures. Eligibility for pharmacologic treatment was then determined using the Joint British Societies' JBS2 and the British Hypertension Society BHS-IV guidelines based on actual and rounded blood pressure values. Zero end-digits were recorded in 64% of systolic and 62% of diastolic blood pressures. When eligibility for drug treatment was based only on a Framingham 10year CVD risk threshold of 20% or more, rounding misclassified one in 41 of all those patients subject to this error. Under the two guidelines which use different combinations of CVD risk and blood pressure thresholds, one in 19 would be misclassified under JBS2 and one in 12 under the BHS-IV guidelines mostly towards increased treatment. Zero end-digit preference significantly increases a patient's likelihood of being classified as eligible for drug treatment. Guidelines that base treatment decisions primarily on absolute CVD risk are less susceptible to these errors.

Feasibility of outpatient total hip and knee arthroplasty in unselected patients

PubMed Central

Gromov, Kirill; Kjærsgaard-Andersen, Per; Revald, Peter; Kehlet, Henrik; Husted, Henrik

2017-01-01

Background and purpose The number of patients who are suitable for outpatient total hip and knee arthroplasty (THA and TKA) in an unselected patient population remains unknown. The purpose of this prospective 2-center study was to identify the number of patients suitable for outpatient THA and TKA in an unselected patient population, to investigate the proportion of patients who were discharged on the day of surgery (DOS), and to identify reasons for not being discharged on the DOS. Patients and methods All consecutive, unselected patients who were referred to 2 participating centers and who were scheduled for primary THA and TKA were screened for eligibility for outpatient surgery with discharge to home on DOS. If patients did not fulfill the discharge criteria, the reasons preventing discharge were noted. Odds factors with relative risk intervals for not being discharged on DOS were identified while adjusting for age, sex, ASA score, BMI and distance to home. Results Of the 557 patients who were referred to the participating surgeons during the study period, 54% were potentially eligible for outpatient surgery. Actual DOS discharge occurred in 13–15% of the 557 patients. Female sex and surgery late in the day increased the odds of not being discharged on the DOS. Interpretation This study shows that even in unselected THA and TKA patients, same-day discharge is feasible in about 15% of patients. Future studies should evaluate safety aspects and economic benefits. PMID:28426262

Efficacy and safety of frontline rituximab, cyclophosphamide, doxorubicin and prednisone plus bortezomib (VR-CAP) or vincristine (R-CHOP) in a subset of newly diagnosed mantle cell lymphoma patients medically eligible for transplantation in the randomized, phase 3 LYM-3002 study.

PubMed

Drach, Johannes; Huang, Huiqiang; Samoilova, Olga; Belch, Andrew; Farber, Charles; Bosly, André; Novak, Jan; Zaucha, Jan; Dascalescu, Angela; Bunworasate, Udomsak; Masliak, Zvenyslava; Vilchevskaya, Kateryna; Robak, Tadeusz; Pei, Lixia; Rooney, Brendan; van de Velde, Helgi; Cavalli, Franco

2018-04-01

This post-hoc subanalysis of the LYM-3002 phase 3 study assessed the efficacy and safety of substituting vincristine in rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHOP; n = 42) for bortezomib (VR-CAP; n = 38) in a subgroup of 80 mantle cell lymphoma (MCL) patients aged <60 years who did not receive stem cell transplantation (SCT) despite medical eligibility. Complete response (CR)/unconfirmed CR (CRu) rates were 67 vs. 39% (odds ratio 3.69 [95% CI(confidence interval): 1.31, 10.41]; p = .012). After 40 months median follow-up, median progression-free survival by independent radiology committee with VR-CAP vs. R-CHOP was 32.6 vs. 12.0 months (hazard ratio (HR) 0.59 [95% CI: 0.31, 1.13]; p = .108); median overall survival was not reached vs. 47.3 months (HR 0.81 [95% CI: 0.33, 1.96]; p = .634). Adverse events included neutropenia (92/76%), thrombocytopenia (70/10%) and leukopenia (65/50%). VR-CAP represents a potential alternative to R-CHOP in combined and/or alternating regimens for younger, SCT-eligible MCL patients.

Acceptability of a Touch Screen Tablet Psychosocial Survey Administered to Radiation Therapy Patients in Japan.

PubMed

Suzuki, Eiji; Mackenzie, Lisa; Sanson-Fisher, Robert; Carey, Mariko; D'Este, Catherine; Asada, Hiromi; Toi, Masakazu

2016-08-01

Studies in western clinical settings suggest that touch screen computer surveys are an acceptable mode of collecting information about cancer patients' wellbeing We examined the acceptability of a touch screen tablet survey among cancer patients in Japan. Eligible patients (n = 262) attending a university hospital radiation therapy (RT) department were invited to complete a touch screen tablet survey about psychosocial communication and care. Survey consent and completion rates, the proportion and characteristics of patients who completed the touch screen survey unassisted, and patient-reported acceptability were assessed. Of 158 consenting patients (consent rate 60 % [95 % CI 54, 66 %] of eligible patients), 152 completed the touch screen computer survey (completion rate 58 % [95 % CI 52, 64 %] of eligible patients). The survey was completed without assistance by 74 % (n = 113; 95 % CI 67, 81 %) of respondents. Older age was associated with higher odds of having assistance with survey completion (OR 1.09; 95 % CI 1.04, 1.14 %). Ninety-two percent of patients (95 % CI 86, 96 %) felt that the touch screen survey was easy to use and 95 % (95 % CI 90, 98 %) agreed or strongly agreed that they were comfortable answering the questions. Overall, 65 % (95 % CI 57, 73 %) of respondents would be willing to complete such a survey more than once while waiting for RT treatment. Although patient self-reported acceptability of the touch screen survey was high, self-administered touch screen tablet surveys may not be entirely appropriate for older cancer patients or possibly for patients with lower educational attainment.

Trends in Medicare Part D Medication Therapy Management Eligibility Criteria

PubMed Central

Wang, Junling; Shih, Ya-Chen Tina; Qin, Yolanda; Young, Theo; Thomas, Zachary; Spivey, Christina A.; Solomon, David K.; Chisholm-Burns, Marie

2015-01-01

Background To increase the enrollment rate of medication therapy management (MTM) programs in Medicare Part D plans, the US Centers for Medicare & Medicaid Services (CMS) lowered the allowable eligibility thresholds based on the number of chronic diseases and Part D drugs for Medicare Part D plans for 2010 and after. However, an increase in MTM enrollment rates has not been realized. Objectives To describe trends in MTM eligibility thresholds used by Medicare Part D plans and to identify patterns that may hinder enrollment in MTM programs. Methods This study analyzed data extracted from the Medicare Part D MTM Programs Fact Sheets (2008–2014). The annual percentages of utilizing each threshold value of the number of chronic diseases and Part D drugs, as well as other aspects of MTM enrollment practices, were analyzed among Medicare MTM programs that were established by Medicare Part D plans. Results For 2010 and after, increased proportions of Medicare Part D plans set their eligibility thresholds at the maximum numbers allowable. For example, in 2008, 48.7% of Medicare Part D plans (N = 347:712) opened MTM enrollment to Medicare beneficiaries with only 2 chronic disease states (specific diseases varied between plans), whereas the other half restricted enrollment to patients with a minimum of 3 to 5 chronic disease states. After 2010, only approximately 20% of plans opened their MTM enrollment to patients with 2 chronic disease states, with the remaining 80% restricting enrollment to patients with 3 or more chronic diseases. Conclusion The policy change by CMS for 2010 and after is associated with increased proportions of plans setting their MTM eligibility thresholds at the maximum numbers allowable. Changes to the eligibility thresholds by Medicare Part D plans might have acted as a barrier for increased MTM enrollment. Thus, CMS may need to identify alternative strategies to increase MTM enrollment in Medicare plans. PMID:26380030

Clinical Presentation, Predictors, and Outcomes Among Mineralocorticoid Receptor Antagonist (MRA)-Eligible Acute Heart Failure Patients in the Heart Function Assessment Registry Trial in Saudi Arabia (HEARTS).

PubMed

AlShamiri, Mostafa Q; AlHabib, Khalid F; AlHabeeb, Waleed; Raslan, Ismail R; Ullah, Anhar; Elasfar, Abdelfatah A; Alshaer, Fayez; Albackr, Hanan; Mimish, Layth; Almasood, Ali; AlGhamdi, Saleh; Ghabashi, Abdullah

2018-04-01

Mineralocorticoid receptor antagonist (MRA) therapy is indicated after myocardial infarction in patients with acute heart failure (AHF) with an ejection fraction ≤40% and lacking contraindications. We analyzed clinical presentations, predictors, and outcomes of MRA-eligible patients within a prospective registry of patients with AHF from 18 hospitals in Saudi Arabia, from 2009 to 2010. For this subgroup, mortality rates were followed until 2013, and the clinical characteristics, management, predictors, and outcomes were compared between MRA-treated and non-MRA-treated patients. Of 2609 patients with AHF, 387 (14.8%) were MRA eligible, of which 146 (37.7%) were prescribed MRAs. Compared with non-MRA-treated patients, those prescribed MRAs more commonly exhibited non-ST-segment elevation myocardial infarction, acute on chronic heart failure, past history of ischemic heart disease, and severe left ventricular systolic dysfunction; were more commonly administered oral furosemide and digoxin; and had higher in-hospital recurrent congestive HF rates. Mortality did not significantly differ ( P > .05) between groups. In Saudi Arabia, 37.7% of eligible patients received MRA treatment, which is higher than that in developed countries. The lack of long-term survival benefit raises concerns about systematic problems, for example, proper follow-up and management after hospital discharge, warranting further investigation.

Mortality and missed opportunities along the pathway of care for ST-elevation myocardial infarction: a national cohort study.

PubMed

Simms, A D; Weston, C F; West, R M; Hall, A S; Batin, P D; Timmis, A; Hemingway, H; Fox, Kaa; Gale, C P

2015-06-01

To examine the association between cumulative missed opportunities for care (CMOC) and mortality in patients with ST-elevation myocardial infarction (STEMI). A cohort study of 112,286 STEMI patients discharged from hospital alive between January 2007 and December 2010, using data from the Myocardial Ischaemia National Audit Project (MINAP). A CMOC score was calculated for each patient and included: pre-hospital ECG, acute use of aspirin, timely reperfusion, prescription at hospital discharge of aspirin, thienopyridine inhibitor, ACE-inhibitor (or equivalent), HMG-CoA reductase inhibitor and β-blocker, and referral for cardiac rehabilitation. Mixed-effects logistic regression models evaluated the effect of CMOC on risk-adjusted 30-day and 1-year mortality (RAMR). 44.5% of patients were ineligible for ≥1 care component. Of patients eligible for all nine components, 50.6% missed ≥1 opportunity. Pre-hospital ECG and timely reperfusion were most frequently missed, predicting further missed care at discharge (pre-hospital ECG incident rate ratio [95% CI]: 1.64 [1.58-1.70]; timely reperfusion 9.94 [9.51-10.40]). Patients ineligible for care had higher RAMR than those eligible for care (30-days: 1.7% vs. 1.1%; 1-year: 8.6% vs. 5.2%), whilst those with no missed care had lower mortality than patients with ≥4 CMOC (30-days: 0.5% vs. 5.4%, adjusted OR (aOR) per CMOC group 1.22, 95% CI: 1.05-1.42; 1-year: 3.2% vs. 22.8%, aOR 1.23, 1.13-1.34). Opportunities for care in STEMI are commonly missed and significantly associated with early and later mortality. Thus, outcomes after STEMI may be improved by greater attention to missed opportunities to eligible care. © The European Society of Cardiology 2014.

Timing and Outcome of Referral to the First Stand-Alone Palliative Care Center in the Eastern Mediterranean Region, the Palliative Care Center of Kuwait.

PubMed

Al-Saleh, Khaled; Al-Awadi, Ahmad; Soliman, Najla A; Mostafa, Sobhy; Mostafa, Mohammad; Mostafa, Wafaa; Alsirafy, Samy A

2017-05-01

Compared to other regions of the world, palliative care (PC) in the Eastern Mediterranean region is at an earlier stage of development. The Palliative Care Center of Kuwait (PCC-K) was established a few years ago as the first stand-alone PC center in the region. This study was conducted to investigate the timing of referral to the PCC-K and its outcome. Retrospective review of referrals to the PCC-K during its first 3 years of action. Late referral was defined as referral during the last 30 days of life. During the 3-year period, 498 patients with cancer were referred to the PCC-K of whom 467 were eligible for analysis. Referral was considered late in 58% of patients. Nononcology facilities were more likely to refer patients late when compared to oncology facilities ( P = .033). The palliative performance scale (PPS) was ≤30 in 59% of late referrals and 21% in earlier referrals ( P < .001). Among 467 referred patients, 342 (73%) were eligible for transfer to the PCC-K, 102 (22%) were ineligible, and 23 (5%) died before assessment by the PCC-K consultation team. From the 342 eligible patients, the family caregivers refused the transfer of 64 (19%) patients to the PCC-K. Patients are frequently referred late to the PCC-K. Further research to identify barriers to PC and its early integration in Kuwait is required. The PPS may be useful in identifying late referrals.

Clinical Practice Patterns and Cost-Effectiveness of HER2 Testing Strategies in Breast Cancer Patients

PubMed Central

Phillips, Kathryn A.; Marshall, Deborah A.; Haas, Jennifer S.; Elkin, Elena B.; Liang, Su-Ying; Hassett, Michael J.; Ferrusi, Ilia; Brock, Jane E.; Van Bebber, Stephanie L

2009-01-01

Background Testing technologies are increasingly used to target cancer therapies. Human epidermal growth factor receptor 2 (HER2) testing to target trastuzumab for patients with breast cancer provides insights into the evidence needed for emerging testing technologies. Methods We reviewed literature on HER2 test utilization and cost-effectiveness of HER2 testing for patients with breast cancer. We examined available evidence on: percentage of eligible patients tested for HER2; test methods used; concordance of test results between community and central/reference laboratories; use of trastuzumab by HER2 test result; and cost-effectiveness of testing strategies. Results Little evidence is available to determine whether all eligible patients are tested; how many are retested to confirm results; and how many with negative HER2 test results still receive trastuzumab. Studies suggest that up to 66% of eligible patients had no documentation of testing in claims records; up to 20% of patients receiving trastuzumab were not tested or had no documentation of a positive test; and 20% of HER2 results may be incorrect. Few cost-effectiveness analyses of trastuzumab explicitly considered the economic implications of various testing strategies. Conclusions There is little information about the actual use of HER2 testing in clinical practice, but evidence suggests important variations in testing practices and key gaps in knowledge exist. Given the increasing use of targeted therapies, it is critical to build an evidence base that supports informed decision-making on emerging testing technologies in cancer care. PMID:19753618

Three-dimensional, task-specific robot therapy of the arm after stroke: a multicentre, parallel-group randomised trial.

PubMed

Klamroth-Marganska, Verena; Blanco, Javier; Campen, Katrin; Curt, Armin; Dietz, Volker; Ettlin, Thierry; Felder, Morena; Fellinghauer, Bernd; Guidali, Marco; Kollmar, Anja; Luft, Andreas; Nef, Tobias; Schuster-Amft, Corina; Stahel, Werner; Riener, Robert

2014-02-01

Arm hemiparesis secondary to stroke is common and disabling. We aimed to assess whether robotic training of an affected arm with ARMin--an exoskeleton robot that allows task-specific training in three dimensions-reduces motor impairment more effectively than does conventional therapy. In a prospective, multicentre, parallel-group randomised trial, we enrolled patients who had had motor impairment for more than 6 months and moderate-to-severe arm paresis after a cerebrovascular accident who met our eligibility criteria from four centres in Switzerland. Eligible patients were randomly assigned (1:1) to receive robotic or conventional therapy using a centre-stratified randomisation procedure. For both groups, therapy was given for at least 45 min three times a week for 8 weeks (total 24 sessions). The primary outcome was change in score on the arm (upper extremity) section of the Fugl-Meyer assessment (FMA-UE). Assessors tested patients immediately before therapy, after 4 weeks of therapy, at the end of therapy, and 16 weeks and 34 weeks after start of therapy. Assessors were masked to treatment allocation, but patients, therapists, and data analysts were unmasked. Analyses were by modified intention to treat. This study is registered with ClinicalTrials.gov, number NCT00719433. Between May 4, 2009, and Sept 3, 2012, 143 individuals were tested for eligibility, of whom 77 were eligible and agreed to participate. 38 patients assigned to robotic therapy and 35 assigned to conventional therapy were included in analyses. Patients assigned to robotic therapy had significantly greater improvements in motor function in the affected arm over the course of the study as measured by FMA-UE than did those assigned to conventional therapy (F=4.1, p=0.041; mean difference in score 0.78 points, 95% CI 0.03-1.53). No serious adverse events related to the study occurred. Neurorehabilitation therapy including task-oriented training with an exoskeleton robot can enhance improvement of motor function in a chronically impaired paretic arm after stroke more effectively than conventional therapy. However, the absolute difference between effects of robotic and conventional therapy in our study was small and of weak significance, which leaves the clinical relevance in question. Swiss National Science Foundation and Bangerter-Rhyner Stiftung. Copyright © 2014 Elsevier Ltd. All rights reserved.

Impact of Death by Suicide of Patients on Thai Psychiatrists

ERIC Educational Resources Information Center

Thomyangkoon, Prakarn; Leenaars, Antoon

2008-01-01

The objective of this study was to identify the impact of a patient's suicide on psychiatrists in Thailand. A confidential coded postal questionnaire survey was sent to 320 eligible psychiatrists; with a response rate of 52.18%. The results showed that 94 (56.28%) of responding psychiatrists had a patient die by suicide, consistent with high rates…

Comparison and Agreement Between the Richmond Agitation-Sedation Scale and the Riker Sedation-Agitation Scale in Evaluating Patients’ Eligibility for Delirium Assessment in the ICU

PubMed Central

Guzman, Oscar; Campbell, Noll L.; Walroth, Todd; Tricker, Jason L.; Hui, Siu L.; Perkins, Anthony; Zawahiri, Mohammed; Buckley, John D.; Farber, Mark O.; Ely, E. Wesley; Boustani, Malaz A.

2012-01-01

Background: Delirium evaluation in patients in the ICU requires the use of an arousal/sedation assessment tool prior to assessing consciousness. The Richmond Agitation-Sedation Scale (RASS) and the Riker Sedation-Agitation Scale (SAS) are well-validated arousal/sedation tools. We sought to assess the concordance of RASS and SAS assessments in determining eligibility of patients in the ICU for delirium screening using the confusion assessment method for the ICU (CAM-ICU). Methods: We performed a prospective cohort study in the adult medical, surgical, and progressive (step-down) ICUs of a tertiary care, university-affiliated, urban hospital in Indianapolis, Indiana. The cohort included 975 admissions to the ICU between January and October 2009. Results: The outcome measures of interest were the correlation and agreement between RASS and SAS measurements. In 2,469 RASS and SAS paired screens, the rank correlation using the Spearman correlation coefficient was 0.91, and the agreement between the two screening tools for assessing CAM-ICU eligibility as estimated by the κ coefficient was 0.93. Analysis showed that 70.1% of screens were eligible for CAM-ICU assessment using RASS (7.1% sedated [RASS −3 to −1]; 62.6% calm [0]; and 0.4% restless, agitated [+1 to +3]), compared with 72.1% using SAS (5% sedated [SAS 3]; 66.5% calm [4]; and 0.6% anxious, agitated [5, 6]). In the mechanically ventilated subgroup, RASS identified 19.1% CAM-ICU eligible patients compared with 24.6% by SAS. The correlation coefficient in this subgroup was 0.70 and the agreement was 0.81. Conclusion: Both SAS and RASS led to similar rates of delirium assessment using the CAM-ICU. PMID:22539644

Rationale and design of the Post-MI FREEE trial: A randomized evaluation of first-dollar drug coverage for post–myocardial infarction secondary preventive therapies

PubMed Central

Choudhry, Niteesh K.; Brennan, Troyen; Toscano, Michele; Spettell, Claire; Glynn, Robert J.; Rubino, Mark; Schneeweiss, Sebastian; Brookhart, Alan M.; Fernandes, Joaquim; Mathew, Susan; Christiansen, Blake; Antman, Elliott M.; Avorn, Jerry; Shrank, William H.

2009-01-01

Background Medication nonadherence is a major public health problem, especially for patients with coronary artery disease. The cost of prescription drugs is a central reason for nonadherence, even for patients with drug insurance. Removing patient out-of-pocket drug costs may increase adherence, improve clinical outcomes, and even reduce overall health costs for high-risk patients. The existing data are inadequate to assess whether this strategy is effective. Trial Design The Post-Myocardial Infarction Free Rx and Economic Evaluation (Post-MI FREEE) trial aims to evaluate the effect of providing full prescription drug coverage (ie, no copays, coinsurance, or deductibles) for statins, β-blockers, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers to patients after being recently discharged from the hospital. Potentially eligible patients will be those individuals who receive their health and pharmacy benefits through Aetna, Inc. Patients enrolled in a Health Savings Account plan, who are ≥65 years of age, whose plan sponsor (ie, the employer, union, government, or association that sponsors the particular benefits package) has opted out of participating in the study, and who do not receive both medical services and pharmacy coverage through Aetna will be excluded. The plan sponsor of each eligible patient will be block randomized to either full drug coverage or current levels of pharmacy benefit, and all subsequently eligible patients of that same plan sponsor will be assigned to the same benefits group. The primary outcome of the trial is a composite clinical outcome of readmission for acute MI, unstable angina, stroke, congestive heart failure, revascularization, or inhospital cardiovascular death. Secondary outcomes include medication adherence and health care costs. All patients will be followed up for a minimum of 1 year. Conclusion The Post-MI FREEE trial will be the first randomized study to evaluate the impact of reducing cost-sharing for essential cardiac medications in high-risk patients on clinical and economic outcomes. PMID:18585494

FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): a multicentre pilot randomised controlled trial of high-flow nasal cannula therapy versus continuous positive airway pressure in paediatric critical care.

PubMed

Ramnarayan, Padmanabhan; Lister, Paula; Dominguez, Troy; Habibi, Parviz; Edmonds, Naomi; Canter, Ruth R; Wulff, Jerome; Harrison, David A; Mouncey, Paul M; Peters, Mark J

2018-06-04

Although high-flow nasal cannula therapy (HFNC) has become a popular mode of non-invasive respiratory support (NRS) in critically ill children, there are no randomised controlled trials (RCTs) comparing it with continuous positive airway pressure (CPAP). We performed a pilot RCT to explore the feasibility, and inform the design and conduct, of a future large pragmatic RCT comparing HFNC and CPAP in paediatric critical care. In this multi-centre pilot RCT, eligible patients were recruited to either Group A (step-up NRS) or Group B (step-down NRS). Participants were randomised (1:1) using sealed opaque envelopes to either CPAP or HFNC as their first-line mode of NRS. Consent was sought after randomisation in emergency situations. The primary study outcomes were related to feasibility (number of eligible patients in each group, proportion of eligible patients randomised, consent rate, and measures of adherence to study algorithms). Data were collected on safety and a range of patient outcomes in order to inform the choice of a primary outcome measure for the future RCT. Overall, 121/254 eligible patients (47.6%) were randomised (Group A 60%, Group B 44.2%) over a 10-month period (recruitment rate for Group A, 1 patient/site/month; Group B, 2.8 patients/site/month). In Group A, consent was obtained in 29/33 parents/guardians approached (87.9%), while in Group B 84/118 consented (71.2%). Intention-to-treat analysis included 113 patients (HFNC 59, CPAP 54). Most reported adverse events were mild/moderate (HFNC 8/59, CPAP 9/54). More patients switched treatment from HFNC to CPAP (Group A: 7/16, 44%; Group B: 9/43, 21%) than from CPAP to HFNC (Group A: 3/13, 23%; Group B: 5/41, 12%). Intubation occurred within 72 h in 15/59 (25.4%) of HFNC patients and 10/54 (18.5%) of CPAP patients (p = 0.38). HFNC patients experienced fewer ventilator-free days at day 28 (Group A: 19.6 vs. 23.5; Group B: 21.8 vs. 22.2). Our pilot trial confirms that, following minor changes to consent procedures and treatment algorithms, it is feasible to conduct a large national RCT of non-invasive respiratory support in the paediatric critical care setting in both step-up and step-down NRS patients. clinicaltrials.gov, NCT02612415 . Registered on 23 November 2015.

Drug resistance mutations in HIV type 1 isolates from naive patients eligible for first line antiretroviral therapy in JJ Hospital, Mumbai, India.

PubMed

Deshpande, Alake; Karki, Surendra; Recordon-Pinson, Patricia; Fleury, Herve J

2011-12-01

More than 50 HIV-1-infected patients, naive of antiretroviral therapy (ART) but eligible for first line ART in JJ Hospital, Mumbai, India were investigated for surveillance drug resistance mutations (SDRMs); all but one virus belonged to subtype C; we could observe SDRMs to nonnucleoside reverse transcriptase inhibitors and protease inhibitors in 9.6% of the patients.

Clinically Unsuspected Prion Disease Among Patients With Dementia Diagnoses in an Alzheimer's Disease Database.

PubMed

Maddox, Ryan A; Blase, J L; Mercaldo, N D; Harvey, A R; Schonberger, L B; Kukull, W A; Belay, E D

2015-12-01

Brain tissue analysis is necessary to confirm prion diseases. Clinically unsuspected cases may be identified through neuropathologic testing. National Alzheimer's Coordinating Center (NACC) Minimum and Neuropathologic Data Set for 1984 to 2005 were reviewed. Eligible patients had dementia, underwent autopsy, had available neuropathologic data, belonged to a currently funded Alzheimer's Disease Center (ADC), and were coded as having an Alzheimer's disease clinical diagnosis or a nonprion disease etiology. For the eligible patients with neuropathology indicating prion disease, further clinical information, collected from the reporting ADC, determined whether prion disease was considered before autopsy. Of 6000 eligible patients in the NACC database, 7 (0.12%) were clinically unsuspected but autopsy-confirmed prion disease cases. The proportion of patients with dementia with clinically unrecognized but autopsy-confirmed prion disease was small. Besides confirming clinically suspected cases, neuropathology is useful to identify unsuspected clinically atypical cases of prion disease. © The Author(s) 2015.

External validity of the ARISTOTLE trial in real-life atrial fibrillation patients.

PubMed

Hägg, Lovisa; Johansson, Cecilia; Jansson, Jan-Håkan; Johansson, Lars

2014-10-01

Our primary objective was to determine the proportion of patients with atrial fibrillation (AF) eligible for enrollment in a randomized controlled trial for a novel oral anticoagulant, the ARISTOTLE trial. A secondary objective was to describe the reasons for trial ineligibility. We performed a cross-sectional study of an unselected population including 2274 patients in Skellefteå, Sweden with at least one verified episode of AF on or before December 31, 2010. Patients were classified as suitable or unsuitable for anticoagulant treatment according to current guidelines. The enrollment criteria from the ARISTOTLE trial were extracted from the original publication and applied to the population. Among all patients with AF, 1579 were classified as suitable for anticoagulant treatment. Of these, only 658 patients (42%) were eligible for participation in the ARISTOTLE trial. Among the 921 patients ineligible for participation, 498 did not meet the ECG criteria, 272 had psychosocial problems, and in addition, 78 patients were excluded due to both of these criteria. Our study shows that a majority of the patients in an unselected population with AF suitable for anticoagulant treatment were ineligible for participation in the ARISTOTLE trial. The applicability of the ARISTOTLE trial is therefore unknown for a considerable proportion of patients with AF in real life. © 2014 John Wiley & Sons Ltd.

Optimizing the induction chemotherapy regimen for patients with locoregionally advanced nasopharyngeal Carcinoma: A big-data intelligence platform-based analysis.

PubMed

Peng, Hao; Tang, Ling-Long; Chen, Bin-Bin; Chen, Lei; Li, Wen-Fei; Mao, Yan-Ping; Liu, Xu; Zhang, Yuan; Liu, Li-Zhi; Tian, Li; Guo, Ying; Sun, Ying; Ma, Jun

2018-04-01

This study aimed at identifying the optimal induction chemotherapy regimen for patients with locoregionally advanced nasopharyngeal carcinoma (NPC) treated by intensity-modulated radiotherapy. We identified eligible patients with newly-diagnosed stage III-IVA NPC (excluding T3N0) between September 2009 and May 2015. Survival outcomes and grade 3-4 toxicities were compared between different IC regimen groups. In total, 3738 patients were eligible for this study, with 1572 (42.1%), 1085 (29.0%) and 1081 (28.9%) receiving TPF, PF and TP, respectively. In the whole population, multivariate analysis found that TPF seems to be better than PF and TP. Howerver, subgroup analysis revealed TPF and TP had same effectiveness in patients receiving a cumulative cisplatin dose (CCD) ≥200mg/m 2 in concurrent chemotherapy, while TPF shows relatively better survival benefit in patients receiving CCD<200mg/m 2 . Grade 3-4 toxicities were similar between TPF and TP groups, but were relatively higher than that in PF group. Our study concluded that induction TP regimen may be enough for patients receiving a CCD≥200mg/m 2 , while TPF may be superior to TP and PF for patients receiving a CCD<200mg/m 2 , although grade 3-4 toxic events were more common but tolerable. Further studies are needed to validate our findings. Copyright © 2018 Elsevier Ltd. All rights reserved.

Barriers and facilitators to the implementation of orthodontic mini implants in clinical practice: a systematic review.

PubMed

Meursinge Reynders, Reint; Ronchi, Laura; Ladu, Luisa; Di Girolamo, Nicola; de Lange, Jan; Roberts, Nia; Mickan, Sharon

2016-09-23

Numerous surveys have shown that orthodontic mini implants (OMIs) are underused in clinical practice. To investigate this implementation issue, we conducted a systematic review to (1) identify barriers and facilitators to the implementation of OMIs for all potential stakeholders and (2) quantify these implementation constructs, i.e., record their prevalence. We also recorded the prevalence of clinicians in the eligible studies that do not use OMIs. Methods were based on our published protocol. Broad-spectrum eligibility criteria were defined. A barrier was defined as any variable that impedes or obstructs the use of OMIs and a facilitator as any variable that eases and promotes their use. Over 30 databases including gray literature were searched until 15 January 2016. The Joanna Briggs Institute tool for studies reporting prevalence and incidence data was used to critically appraise the included studies. Outcomes were qualitatively synthesized, and meta-analyses were only conducted when pre-set criteria were fulfilled. Three reviewers conducted all research procedures independently. We also contacted authors of eligible studies to obtain additional information. Three surveys fulfilled the eligibility criteria. Seventeen implementation constructs were identified in these studies and were extracted from a total of 165 patients and 1391 clinicians. Eight of the 17 constructs were scored by more than 50 % of the pertinent stakeholders. Three of these constructs overlapped between studies. Contacting of authors clarified various uncertainties but was not always successful. Limitations of the eligible studies included (1) the small number of studies; (2) not defining the research questions, i.e., the primary outcomes; (3) the research design (surveys) of the studies and the exclusive use of closed-ended questions; (4) not consulting standards for identifying implementation constructs; (5) the lack of pilot testing; (6) high heterogeneity; (7) the risk of reporting bias; and (8) additional shortcomings. Meta-analyses were not possible because of these limitations. Two eligible studies found that respectively 56.3 % (952/1691) and 40.16 % (439/1093) of clinicians do not use OMIs. Notwithstanding the limitations of the eligible studies, their findings were important because (1) 17 implementation constructs were identified of which 8 were scored by more than 50 % of the stakeholders; (2) the various shortcomings showed how to improve on future implementation studies; and (3) the underuse of OMIs in the selected studies and in the literature demonstrated the need to identify, quantify, and address implementation constructs. Prioritizing of future research questions on OMIs with all pertinent stakeholders is an important first step and could redirect research studies on OMIs towards implementation issues. Patients, clinicians, researchers, policymakers, insurance companies, implant companies, and research sponsors will all be beneficiaries.

Variation in CAD Secondary Prevention Prescription among Outpatient Cardiology Practices: Insights from the NCDR®

PubMed Central

Maddox, Thomas M.; Chan, Paul S.; Spertus, John A.; Tang, Fengming; Jones, Phil; Ho, P. Michael; Bradley, Steven M.; Tsai, Thomas T.; Bhatt, Deepak L.; Peterson, Pamela N.

2014-01-01

Objectives This study assesses practice variation of secondary prevention medication prescription among coronary artery disease (CAD) patients treated in outpatient practices participating in the NCDR® PINNACLE Registry®. Background Among patients with CAD, secondary prevention with a combination of beta-blockers, angiotensin converting enzyme inhibitors/angiotensin receptor blockers, and statins reduces cardiac mortality and myocardial infarction (MI). Accordingly, every CAD patient should receive the combination of these medications for which they are eligible. However, little is known about current prescription patterns of these medications and the variation in use among outpatient cardiology clinics. Methods Using data from NCDR® PINNACLE Registry®, a national outpatient cardiology practice registry, we assessed medication prescription patterns among eligible CAD patients between July 2008 and December 2010. Overall rates of prescription and variation by practice were calculated, adjusting for patient characteristics. Results Among 156,145 CAD patients in 58 practices, 103,830 (66.5%) were prescribed the optimal combination of medications for which they were eligible. The median rate of optimal combined prescription by practice was 73.5% and varied from 28.8% to 100%. After adjustment for patient factors, the practice median rate ratio for prescription was 1.25 (95% CI 1.2,1.32), indicating a 25% likelihood that 2 random practices would differ in treating identical CAD patients. Conclusions Among a national registry of CAD patients treated in outpatient cardiology practices, over one-third of patients failed to receive their optimal combination of secondary prevention medications. Significant variation was observed across practices, even after adjusting for patient characteristics, suggesting that quality improvement efforts may be needed to support more uniform practice. PMID:24184238

A Formative Evaluation of a Diabetes Prevention Program Using the RE-AIM Framework in a Learning Health Care System, Utah, 2013-2015.

PubMed

Brunisholz, Kimberly D; Kim, Jaewhan; Savitz, Lucy A; Hashibe, Mia; Gren, Lisa H; Hamilton, Sharon; Huynh, Kelly; Joy, Elizabeth A

2017-07-20

Evaluation of interventions can help to close the gap between research and practice but seldom takes place during implementation. Using the RE-AIM framework, we conducted a formative evaluation of the first year of the Intermountain Healthcare Diabetes Prevention Program (DPP). Adult patients who met the criteria for prediabetes (HbA1c of 5.70%-6.49% or fasting plasma glucose of 100-125 mg/dL) were attributed to a primary care provider from August 1, 2013, through July 31, 2014. Physicians invited eligible patients to participate in the program during an office visit. We evaluated 1) reach, with data on patient eligibility, participation, and representativeness; 2) effectiveness, with data on attaining a 5% weight loss; 3) adoption, with data on providers and clinics that referred patients to the program; and 4) implementation, with data on patient encounters. We did not measure maintenance. Of the 6,862 prediabetes patients who had an in-person office visit with their provider, 8.4% of eligible patients enrolled. Likelihood of participation was higher among patients who were female, aged 70 years or older, or overweight; had depression and higher weight at study enrollment; or were prescribed metformin. DPP participants were more likely than nonparticipants to achieve a 5% weight loss (odds ratio, 1.70; 95% confidence interval, 1.29-2.25; P < .001). Providers from 7 of 8 regions referred patients to the DPP; 174 providers at 53 clinics enrolled patients. The mean number of DPP counseling encounters per patient was 2.3 (range, 1-16). The RE-AIM framework was useful for estimating the formative impact (ie, reach, effectiveness, adoption, and implementation fidelity) of a DPP-based lifestyle intervention deployed in a learning health care system.

Intravenous thrombolysis in ischemic stroke with unknown onset using CT perfusion.

PubMed

Cortijo, E; García-Bermejo, P; Calleja, A I; Pérez-Fernández, S; Gómez, R; del Monte, J M; Reyes, J; Arenillas, J F

2014-03-01

Acute ischemic stroke patients with unclear onset time presenting >4.5 h from last-seen-normal (LSN) time are considered late patients and excluded from i.v. thrombolysis. We aimed to evaluate whether this subgroup of patients is different from patients presenting >4.5 h from a witnessed onset, in terms of eligibility and response to computed tomography perfusion (CTP)-guided i.v. thrombolysis. We prospectively studied consecutive acute non-lacunar middle cerebral artery (MCA) ischemic stroke patients presenting >4.5 h from LSN. All patients underwent multimodal CT and were considered eligible for i.v. thrombolysis according to CTP criteria. Two patient groups were established based on the knowledge of the stroke onset time. We compared the proportion of candidates suitable for intravenous thrombolysis between both groups, and their outcome after thrombolytic therapy. Among 147 MCA ischemic stroke patients presenting >4.5 h from LSN, stroke onset was witnessed in 74 and unknown in 73. Thirty-seven (50%) patients in the first group and 32 (44%) in the second met CTP criteria for thrombolysis (P = 0.7). Baseline variables were comparable between both groups with the exception of age, which was higher in the unclear onset group. The rates of early neurological improvement (54.1% vs 46.9%), 2-h MCA recanalization (43.5% vs 37%), symptomatic hemorrhagic transformation (3% vs 0%) and good 3-month functional outcome (62.2% vs 56.3%) did not differ significantly between both groups. Delayed stroke patients with unknown onset time were no different than patients >4.5 h regarding eligibility and response to CTP-based i.v. thrombolysis. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Continuous versus cyclic oral contraceptives for the treatment of endometriosis: a systematic review.

PubMed

Zorbas, Konstantinos A; Economopoulos, Konstantinos P; Vlahos, Nikos F

2015-07-01

Recurrence of endometriosis after conservative surgery has been observed in 40-50 % of patients within the first 5 years. A variety of regimens such as combined oral contraceptives, GnRH agonists, danazol, and progestins have been used postoperatively to reduce recurrence rates. Oral contraceptives (oCP) have been used either in a cyclic or in a continuous (no pill-free interval) fashion. The purpose of this article was to summarize the existing evidence on the efficacy and patient compliance for the use of oCP in a continuous versus cyclic fashion following conservative surgery for endometriosis. A systematic search of Medline identified four eligible studies. Studies were considered eligible, if they have evaluated oCP therapy, either in a cyclic or continuous regimen, after conservative surgery for endometriosis. Specifically, studies (1) reporting on women with endometriosis who were treated postoperatively with both continuous oCP and cyclic oCP, (2) written in English, (3) with minimum 6 months duration of medical treatment, and (4) with minimum 12 months duration of follow-up were considered eligible for our systematic review. Outcome measures of these eligible studies were tabulated and then analyzed cumulatively. A purely descriptive approach was adopted concerning all variables. Postoperative use of continuous oCP was associated with a reduction in the recurrence rate of dysmenorrhea, delay in the presentation of dysmenorrhea, reduction in nonspecific pelvic pain, and reduction in the recurrence rate for endometrioma. Use of oCP in a continuous fashion following conservative surgery for endometriosis is more beneficial to cyclic use.

Combining motivational and volitional strategies to promote unsupervised walking in patients with fibromyalgia: study protocol for a randomized controlled trial.

PubMed

Pastor, María-Ángeles; López-Roig, Sofía; Lledó, Ana; Peñacoba, Cecilia; Velasco, Lilian; Schweiger-Gallo, Inge; Cigarán, Margarita; Ecija, Carmen; Limón, Ramón; Sanz, Yolanda

2014-04-11

Fibromyalgia patients are often advised to engage in regular low- to moderate-intensity physical exercise. The need of fibromyalgia patients to walk has been stressed in previous research. Behavioral self-regulation theories suggest that a combination of motivational aspects (to develop or strengthen a behavioral intention: Theory of Planned Behavior) and volitional aspects (engagement of intention in behavior: implementation intentions) is more effective than a single intervention. In this paper, we describe a protocol for identifying the motivational processes (using the Theory of Planned Behavior) involved in the practice of walking (phase I) and for studying the efficacy of an intervention that combines motivational and volitional contents to enhance the acquisition and continuation of this exercise behavior (phase II). The paper also shows the characteristics of eligible individuals (women who do not walk) and ineligible populations (women who walk or do not walk because of comorbidity without medical recommendation to walk). Both groups consist of members of any of four patients' associations in Spain who are between 18 and 70 years of age and meet the London Fibromyalgia Epidemiology Study Screening Questionnaire criteria for fibromyalgia. Furthermore, using this study protocol, we will explore the characteristics of participants (eligible women who agreed to participate in the study) and nonparticipants (eligible women who refused to participate). Two studies will be conducted: Phase I will be a cross-sectional study, and phase II will be a triple-blind, randomized longitudinal study with two treatment groups and one active control group. The questionnaires were sent to a total of 2,227 members of four patients' associations in Spain. A total of 920 participants with fibromyalgia returned the questionnaires, and 582 were ultimately selected to participate. The first data gathered have allowed us to identify the characteristics of the study population and they support the appropriateness of the inclusion criteria.. When the study is complete, the results will enable us to establish whether this kind of intervention can be used as a self-regulation tool for increasing and maintaining walking as unsupervised physical exercise of low to moderate intensity in fibromyalgia patients. ISRCTN68584893.

Identifying Human Papillomavirus Vaccination Practices Among Primary Care Providers of Minority, Low-Income and Immigrant Patient Populations

PubMed Central

Bruno, Denise M.; Wilson, Tracey E.; Gany, Francesca; Aragones, Abraham

2014-01-01

Objective Minority populations in the United States are disproportionally affected by Human Papillomavirus (HPV) infection and HPV-related cancer. We sought to understand physician practices, knowledge and beliefs that affect utilization of the HPV vaccine in primary care settings serving large minority populations in areas with increased rates of HPV-related cancer. Study Design Cross-sectional survey of randomly selected primary care providers, including pediatricians, family practice physicians and internists, serving large minority populations in Brooklyn, N.Y. and in areas with higher than average cervical cancer rates. Results Of 156 physicians randomly selected, 121 eligible providers responded to the survey; 64% were pediatricians, 19% were internists and 17% were family practitioners. Thirty-four percent of respondents reported that they routinely offered HPV vaccine to their eligible patients. Seventy percent of physicians reported that the lack of preventive care visits for patients in the eligible age group limited their ability to recommend the HPV vaccine and 70% of those who reported this barrier do not routinely recommend HPV vaccine. The lack of time to educate parents about the HPV vaccine and cost of the vaccine to their patients were two commonly reported barriers that affected whether providers offered the vaccine. Conclusions Our study found that the majority of providers serving the highest risk populations for HPV infection and HPV-related cancers are not routinely recommending the HPV vaccine to their patients. Reasons for providers' failure to recommend the HPV vaccine routinely are identified and possible areas for targeted interventions to increase HPV vaccination rates are discussed. PMID:24886959

Biochemical bone turnover markers in diabetes mellitus - A systematic review.

PubMed

Starup-Linde, Jakob; Vestergaard, Peter

2016-01-01

Diabetes mellitus is associated with an increased risk of fractures, which is not explained by bone mineral density. Other markers as bone turnover markers (BTMs) may be useful. To assess the relationship between BTMs, diabetes, and fractures. A systematic literature search was conducted in August 2014. The databases searched were Medline at Pubmed and Embase. Medline at Pubmed was searched by "Diabetes Mellitus" (MESH) and "bone turnover markers" and Embase was searched using the Emtree by "Diabetes Mellitus" and "bone turnover", resulting in 611 studies. The eligibility criteria for the studies were to assess BTM in either type 1 diabetes (T1D) or type 2 diabetes (T2D) patients. Of the 611 eligible studies, removal of duplicates and screening by title and abstract lead to 114 potential studies for full-text review. All these studies were full-text screened for eligibility and 45 studies were included. Two additional studies were added from other sources. Among the 47 studies included there were 1 meta-analysis, 29 cross-sectional studies, 13 randomized controlled trials, and 4 longitudinal studies. Both T1D and T2D were studied. Most studies reported fasting BTM and excluded renal disease. Markers of bone resorption and formation seem to be lower in diabetes patients. Bone specific alkaline phosphatase is normal or increased, which suggests that the matrix becomes hypermineralized in diabetes patients. The BTMs: C-terminal cross-link of collagen, insulin-like growth factor-1, and sclerostin may potentially predict fractures, but longitudinal trials are needed. This article is part of a Special Issue entitled Bone and diabetes. Copyright © 2015 Elsevier Inc. All rights reserved.

Neoadjuvant chemotherapy regimens in treatment of breast cancer: a systematic review and network meta-analysis protocol.

PubMed

Pathak, Mona; Dwivedi, Sada Nand; Deo, S V S; Thakur, Bhaskar; Sreenivas, Vishnubhatla; Rath, G K

2018-06-26

Neoadjuvant chemotherapy (NACT), a standard of care for locally advanced breast cancer patients, is widely used for early breast cancer patients also. The varying role of regimens used as NACT needs to be investigated. Despite availability of some randomized controlled trials (RCTs), it is unclear which treatment regimen suits best. Further, there is no study comparing all the three regimens. Accordingly, present study will compare the efficacy of anthracyclines, taxanes, and targeted therapy administered in neoadjuvant setting on the basis of oncological outcomes and functional outcomes. Online databases PubMed and Cochrane Register of Controlled Trials will be searched to acquire eligible studies. Further, content of relevant journals, references of relevant articles, and proceedings of major related conference will also be searched. The RCTs comparing any of abovementioned regimen as NACT on breast cancer patients will be eligible. Two reviewers independently and in duplicate will screen the records on the basis of title and abstract and complete full-text review to determine eligibility. Similarly, data extraction and risk of bias assessment will be done by two independent reviewers. The pair-wise meta-analysis as well as network meta-analysis will be conducted to assess the relative efficacy of anthracyclines, taxanes, and targeted therapy regimens. The present systematic review will improve the understanding of the relative efficacies of the three treatment regimens and possibly guide the clinical practices by providing the current best evidence on the efficacy of various regimens of NACT in the management of breast cancer patients. PROSPERO ( CRD42016027236 ).

Dyadic Recruitment in Complementary Therapy Studies: Experience from a Clinical Trial of Caregiver-Delivered Reflexology

PubMed Central

Holmstrom, Amanda J.; Wyatt, Gwen K.; Sikorskii, Alla; Musatics, Catherine; Stolz, Emily; Havener, Neala

2015-01-01

Purpose As home-based care continues to be a growing trend in health care, involvement of friend and family caregivers in the management of illness becomes essential. However, before nurses can prepare caregivers to engage in various types of care, an evidence base needs to be established via randomized controlled trials (RCTs). Research suggests that recruiting cancer patients and their friend or family caregivers into RCTs presents challenges. The purpose of this paper is to illustrate the barriers to recruitment of patient-caregiver dyads into a RCT of caregiver-delivered reflexology and to recommend strategies to address such barriers. Methods This paper reports on a nurse-directed RCT that involved recruitment efforts unique to a caregiver-delivered reflexology protocol for advanced-stage breast cancer patients. Ineligibility due to caregiver-related reasons, consent among eligible patients (out of 551 approached patients), and reasons for refusal were analyzed. Results Almost one-third of patients were found to be ineligible due to the lack of a caregiver to participate with them and provide this form of social support. Among eligible patients, the consent rate for this dyadic study is much lower than that of previous RCTs of reflexologist-delivered reflexology that enrolled just patients, not dyads. Conclusion Implications for nursing practice and research include addressing the need for greater social support for patients and strategies for problem-solving refusal reasons during study enrollment. PMID:26856504

Results of a phase 2 study of pacritinib (SB1518), a JAK2/JAK2(V617F) inhibitor, in patients with myelofibrosis

PubMed Central

Seymour, John F.; Roberts, Andrew W.; Wadleigh, Martha; To, L. Bik; Scherber, Robyn; Turba, Elyce; Dorr, Andrew; Zhu, Joy; Wang, Lixia; Granston, Tanya; Campbell, Mary S.; Mesa, Ruben A.

2015-01-01

Pacritinib (SB1518) is a Janus kinase 2 (JAK2), JAK2(V617F), and Fms-like tyrosine kinase 3 inhibitor that does not inhibit JAK1. It demonstrated a favorable safety profile with promising efficacy in phase 1 studies in patients with primary and secondary myelofibrosis (MF). This multicenter phase 2 study further characterized the safety and efficacy of pacritinib in the treatment of patients with MF. Eligible patients had clinical splenomegaly poorly controlled with standard therapies or were newly diagnosed with intermediate- or high-risk Lille score. Patients with any degree of cytopenia were eligible. Thirty-five patients were enrolled. At entry, 40% had hemoglobin <10 g/dL and 43% had platelets <100 000× 109/L. Up to week 24, 8 of 26 evaluable patients (31%) achieved a ≥35% decrease in spleen volume determined by magnetic resonance imaging and 14 of 33 (42%) attained a ≥50% reduction in spleen size by physical examination. Median MF symptom improvement was ≥50% for all symptoms except fatigue. Grade 1 or 2 diarrhea (69%) and nausea (49%) were the most common treatment-emergent adverse events. The study drug was discontinued in 9 patients (26%) due to adverse events (4 severe). Pacritinib is an active agent in patients with MF, offering a potential treatment option for patients with preexisting anemia and thrombocytopenia. This trial was registered at www.clinicaltrials.gov as #NCT00745550. PMID:25762180

Improving the Efficiency and Efficacy of Glibenclamide in Limiting Progressive Hemorrhagic Necrosis Following Traumatic Spinal Cord Injury

DTIC Science & Technology

2012-10-01

screening for eligible patients “24/7”. The research staff rotates a research dedicated cell phone that acts as a pager. All the neurosurgery residents...have the cell phone number and we get called for all potential eligible patients. We work very closely with the neurosurgery residents; all are

Evaluation of a type 2 diabetes prevention program using a commercial weight management provider for non-diabetic hyperglycemic patients referred by primary care in the UK.

PubMed

Piper, Carolyn; Marossy, Agnes; Griffiths, Zoe; Adegboye, Amanda

2017-01-01

To determine if a diabetes prevention program (DPP) delivered by a commercial weight management provider using a UK primary care referral pathway could reduce the progression to type 2 diabetes (T2D) in those diagnosed with non-diabetic hyperglycemia (NDH-being at high risk of developing T2D). This is a quasi-experimental translational research study. 14 primary care practices identified, recruited and referred patients with NDH (fasting plasma glucose ≥5.5 to ≤6.9 mmol/L and/or glycated hemoglobin (HbA1c) ≥42 to 47 mmol/mol (6.0%-6.4%)) and a body mass index (BMI) ≥30 kg/m 2 to a DPP. Eligible patients were asked to contact Weight Watchers to book onto their DPP, an intensive lifestyle intervention which included a 90 min activation session followed by the offer of 48 weekly Weight Watchers community group meetings. Patients' blood tests were repeated by primary care, weight change plus self-reported data was recorded by Weight Watchers. 166 patients were referred to the program and 149 were eligible. 79% of eligible patients attended an activation session (117 eligible patients) and 77% started the weekly sessions. The study sample was primarily female (75%), white (90%), with 5% living in the most deprived quintile in the UK. Using intention-to-treat analysis, the DPP resulted in a mean reduction in HbA1c of 2.84 mmol/mol at 12 months (from 43.42±1.28 to 40.58±3.41, p<0.01). 38% of patients returned to normoglycemia and 3% developed T2D at 12 months. There was a mean weight reduction in BMI of 3.2 kg/m 2 at 12 months (35.5 kg/m 2 ±5.4 to 32.3 kg/m 2 ±5.2, p<0.01). A UK primary care referral route partnered with this commercial weight management provider can deliver an effective DPP. The lifestyle changes and weight loss achieved in the intervention translated into considerable reductions in diabetes risk, with an immediate and significant public health impact.

Patterns of acquisitive crime during methadone maintenance treatment among patients eligible for heroin assisted treatment.

PubMed

van der Zanden, Bart P; Dijkgraaf, Marcel G W; Blanken, Peter; van Ree, Jan M; van den Brink, Wim

2007-01-05

To determine the patterns of acquisitive crime during methadone maintenance treatment among chronic, treatment-resistant heroin users eligible for heroin assisted treatment in the Netherlands. We retrospectively assessed the type and number of illegal activities during 1 month of standard methadone maintenance treatment in 51 patients prior to the start of heroin assisted treatment. Data were collected using a semi-structured interview focussed on crime with special emphasis on property crime. Volume analyses consisted of frequencies and descriptives of mean numbers of offences per day and per type. In a Dutch population of problematic drug users eligible for and prior to commencing heroin assisted treatment, 70% reported criminal activities and 50% reported acquisitive crimes. Offending took place on 20.5 days per month with on average 3.1 offences a day. Acquisitive crime consisted mainly of shoplifting (mean 12.8 days, 2.2 times/day) and theft of bicycles (mean 5.8 days, 2.4 times/day); theft from a vehicle and burglaries were committed less frequently. The majority of these patients (63%) reported to have started offending in order to acquire illicit drugs and alcohol. During methadone maintenance treatment, 50% of criminally active, problematic heroin users eligible for heroin assisted treatment reported acquisitive crime. Shoplifting, thefts and/or other property crimes were committed on average two to three times on a crime day. This study discusses that the detail provided by self-reported crime data can improve cost estimates in economic evaluations of heroin assisted treatment.

Efficacy of an accelerated recovery protocol for Oxford unicompartmental knee arthroplasty--a randomised controlled trial.

PubMed

Reilly, K A; Beard, D J; Barker, K L; Dodd, C A F; Price, A J; Murray, D W

2005-10-01

Unicompartmental knee arthroplasty (UKA) is appropriate for one in four patients with osteoarthritic knees. This study was performed to compare the safety, effectiveness and economic viability of a new accelerated protocol with current standard care in a state healthcare system. A single blind RCT design was used. Eligible patients were screened for NSAID tolerance, social circumstances and geographical location before allocation to an accelerated recovery group (A) or standard care group (S). Primary outcome was the Oxford Knee Assessment at 6 months post operation, compared using independent Mann-Whitney U-tests. A simple difference in costs incurred was calculated. The study power was sufficient to avoid type 2 errors. Forty-one patients were included. The average stay for Group A was 1.5 days. Group S averaged 4.3 days. No significant difference in outcomes was found between groups. The new protocol achieved cost savings of 27% and significantly reduced hospital bed occupancy. In addition, patient satisfaction was assessed as greater with the accelerated discharge than with the routine discharge time. The strict inclusion criteria meant that 75% of eligible patients were excluded. However, a large percentage of these were due to the distances patients lived from the hospital.

Delirium in acute stroke: a systematic review and meta-analysis.

PubMed

Shi, Qiyun; Presutti, Roseanna; Selchen, Daniel; Saposnik, Gustavo

2012-03-01

Delirium is common in the early stage after hospitalization for an acute stroke. We conducted a systematic review and meta-analysis to evaluate the outcomes of acute stroke patients with delirium. We searched MEDLINE, EMBASE, CINAHL, Cochrane Library databases, and PsychInfo for relevant articles published in English up to September 2011. We included observational studies for review. Two reviewers independently assessed studies to determine eligibility, validity, and quality. The primary outcome was inpatient mortality and secondary outcomes were mortality at 12 months, institutionalization, and length of hospital stay. Among 78 eligible studies, 10 studies (n=2004 patients) met the inclusion criteria. Stroke patients with delirium had higher inpatient mortality (OR, 4.71; 95% CI, 1.85-11.96) and mortality at 12 months (OR, 4.91; 95% CI, 3.18-7.6) compared to nondelirious patients. Patients with delirium also tended to stay longer in hospital compared to those who did not have delirium (mean difference, 9.39 days; 95% CI, 6.67-12.11) and were more likely to be discharged to a nursing homes or other institutions (OR, 3.39; 95% CI, 2.21-5.21). Stroke patients with development of delirium have unfavorable outcomes, particularly higher mortality, longer hospitalizations, and a greater degree of dependence after discharge. Early recognition and prevention of delirium may improve outcomes in stroke patients.

Identifying barriers to medication discharge counselling by pharmacists.

PubMed

Walker, Sandra A N; Lo, Jennifer K; Compani, Sara; Ko, Emily; Le, Minh-Hien; Marchesano, Romina; Natanson, Rimona; Pradhan, Rahim; Rzyczniak, Grace; Teo, Vincent; Vyas, Anju

2014-05-01

Medication errors may occur more frequently at discharge, making discharge counselling a vital facet of medication reconciliation. Discharge counselling is a recognized patient safety initiative for which pharmacists have appropriate expertise, but data are lacking about the barriers to provision of this service to adult inpatients by pharmacists. To determine the proportion of eligible patients who received discharge counselling, to quantify perceived barriers preventing pharmacists from performing discharge counselling, and to determine the relative frequency of barriers and associated time expenditures. In this prospective study, 8 pharmacists working in general medicine, medical oncology, or nephrology wards of an acute care hospital completed a survey for each of the first 50 patients eligible for discharge counselling on their respective wards from June 2010 to February 2011. Patients discharged to another facility (rehabilitation, palliative care, or long-term care), those with hospital stay less than 48 h before discharge, and those whose medications were unchanged from hospital admission were ineligible. Discharge counselling was performed for 116 (29%) of the 403 eligible patients and involved a median preparation time of 25 min and median counselling time of 15 min per patient. At least one documented barrier to discharge counselling existed for 295 (73%) of the patients. Several barriers to discharge counselling occurred significantly more frequently on the general medicine and oncology wards than on the nephrology ward (p < 0.05). The most common barrier was failure to notify the pharmacist about impending patient discharge (130/313 [41%]). Time constraints existed for 130 (32%) of the patients, the most common related to clarification of prescriptions (96 [24%]), creation of a medication list (69 [17%]), and faxing of prescriptions (64 [16%]). This study generated objective data about the barriers to and time constraints associated with medication discharge counselling by pharmacists. These findings should raise awareness of the challenges faced by pharmacists in busy hospital positions and may support avenues of change for their hospital discharge counselling programs.

Adjunctive Corticosteroids for Pneumocystis jirovecii Pneumonia in Non-HIV-infected Patients: A Systematic Review and Meta-analysis of Observational Studies.

PubMed

Fujikura, Yuji; Manabe, Toshie; Kawana, Akihiko; Kohno, Shigeru

2017-02-01

The clinical benefits of adjunctive corticosteroids for Pneumocystis jirovecii (P. jirovecii) pneumonia in patients not infected with the human immunodeficiency virus (HIV) has not been evaluated by meta-analysis. We conducted a systematic review of published studies describing the effects of adjunctive corticosteroids on outcome in non-HIV P. jirovecii pneumonia patients. Two investigators independently searched the PubMed and Cochrane databases for eligible articles written in English. A meta-analysis was performed using a random-effects model for measuring mortality as the primary outcome, and the need for intubation or mechanical ventilation as the secondary outcome. Seven observational studies were eligible. In these studies, adjunctive corticosteroids did not affect mortality in non-HIV patients (odds ratio [OR] 1.26; 95% CI 0.60-2.67) and there was no beneficial effect in patients with severe hypoxemia (PaO 2 <70mmHg) (OR 0.90; 95% CI 0.44-1.83). No significant effect on the secondary outcome was observed (OR 1.34; 95% CI 0.44-4.11). Although the studies were observational, meta-analysis showed that adjunctive corticosteroids did not improve the outcome of P. jirovecii pneumonia in non-HIV patients. The results warrant a randomized controlled trial. Copyright © 2016 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.

Implementation of a Process for Initial Transcranial Doppler Ultrasonography in Children With Sickle Cell Anemia

PubMed Central

Crosby, Lori E.; Joffe, Naomi E.; Davis, Blair; Quinn, Charles T.; Shook, Lisa; Morgan, Darice; Simmons, Kenya; Kalinyak, Karen A.

2016-01-01

Stroke, a devastating complication of sickle cell anemia (SCA), can cause irreversible brain injury with physical and cognitive deficits. Transcranial Doppler ultrasonography (TCD) is a non-invasive tool for identifying children with SCA at highest risk of stroke. National guidelines recommend that TCD screening begin at age 2 years, yet there is research to suggest less than half of young children undergo screening. The purpose of this project was to use quality improvement methods to improve the proportion of patients aged 24–27 months who successfully completed their initial TCD from 25% to 75% by December 31, 2013. Quality improvement methods (e.g., process mapping, simplified failure mode effect analysis, and plan–do–study–act cycles) were used to develop and test processes for identifying eligible patients, scheduling TCDs, preparing children and families for the first TCD, and monitoring outcomes (i.e., TCD protocol). Progress was tracked using a report of eligible patients and a chart showing the age in months for the first successful TCD (population metric). As of December 2013, 100% of eligible patients successfully completed their initial TCD screen; this improvement was maintained for the next 20 months. In November 2014, a Welch’s one-way ANOVA was conducted. Results showed a statistically significant difference between the average age of first TCD for eligible patients born in 2009 and eligible patients born during the intervention period (2010–2013; F[1,11.712]=16.03, p=0.002). Use of quality improvement methods to implement a TCD protocol was associated with improved TCD screening rates in young children with SCA. PMID:27320459

Two randomized controlled studies comparing the nutritional benefits of branched-chain amino acid (BCAA) granules and a BCAA-enriched nutrient mixture for patients with esophageal varices after endoscopic treatment.

PubMed

Sakai, Yoshiyuki; Iwata, Yoshinori; Enomoto, Hirayuki; Saito, Masaki; Yoh, Kazunori; Ishii, Akio; Takashima, Tomoyuki; Aizawa, Nobuhiro; Ikeda, Naoto; Tanaka, Hironori; Iijima, Hiroko; Nishiguchi, Shuhei

2015-01-01

The usefulness of branched-chain amino acid (BCAA) granules and BCAA-enriched nutrient mixtures for patients with liver cirrhosis is often reported. However, no randomized controlled studies have investigated the usefulness of these supplements in the nutritional intervention of cirrhotic patients receiving endoscopic treatment for esophageal varices. Patients without BCAA before endoscopic treatment were divided into study 1, and those who received BCAA were divided into study 2. In study 1, 44 eligible patients were divided into a control group (n = 13), a general liquid nutrient (snack) group (n = 15), and a BCAA-enriched nutrient mixture (BCAA-EN) group (n = 16). In study 2, 48 eligible patients were divided into a BCAA group (n = 24) and a BCAA-EN group (n = 24). The nutritional status including non-protein respiratory quotient (NPRQ) levels, weight gain, and albumin were evaluated on days 0, 7, and 50. In study 1, the BCAA-EN group showed significant improvement in NPRQ levels on day 7 as compared with the snack group. In study 2, the BCAA-EN group showed significant improvement in NPRQ levels on day 7 and in weight levels on day 50 relative to the BCAA group, while the BCAA group showed improved serum albumin levels on day 7 compared to the BCAA-EN group. The BCAA-enriched nutrient mixture maintained NPRQ and weight in cirrhotic patients. Our findings suggest that supplements including both BCAA and a nutritional energy supplement would be beneficial for cirrhotic patients undergoing endoscopic treatment for esophageal varices.

Is response-guided therapy being applied in the clinical setting? The hepatitis C example.

PubMed

Harris, Jennifer B; Ward, Melea A; Schwab, Phil

2015-02-01

Response-guided therapy (RGT) is a treatment model that bases adjustments to therapeutic regimens on individualized patient physiologic response. This approach is applied to patients with chronic hepatitis C virus (HCV) infection who are treated with a triple therapy regimen of boceprevir or telaprevir in combination with pegylated interferon and ribavirin. As RGT expands in other pharmacologic regimens, including the treatment of breast cancer and acute myeloid leukemia, a measurement of how this approach is applied in clinical practice is important to determine whether the benefits of RGT are being optimized. To measure adherence to the RGT guidelines and to the treatment futility rules based on the drug labeling information for boceprevir and for telaprevir in the treatment of patients with chronic HCV infection. A retrospective observational cohort study was conducted using the large Humana research database, which includes pharmacy, medical, and laboratory claims, as well as enrollment data for more than 1.5 million fully insured commercial members, 1.9 million Medicare Advantage members, and 2.4 million Medicare Part D members from all 50 states. The study population included patients aged ≥18 years to <90 years who were fully insured with commercial or Medicare Advantage coverage. A pharmacy claim for boceprevir or telaprevir was used to identify patients receiving triple therapy for HCV infection. Medical, pharmacy, and laboratory claims were reviewed from the date of the first boceprevir or telaprevir pharmacy claim between May 2011 and February 2012 through a 32-week follow-up period, during which patients were required to have continuous health plan enrollment eligibility. This time period allowed for the occurrences of required HCV RNA laboratory monitoring and the assessment of treatment patterns. The use of RGT for boceprevir and telaprevir includes the monitoring of HCV RNA levels at routine intervals to determine how to proceed with therapy. Adherence to HCV RNA monitoring was measured as the proportion of eligible patients who had an HCV RNA assay at each of the recommended time intervals. According to futility rules, patients with greater-than-expected HCV RNA levels are deemed to be nonresponders and should discontinue therapy. Adherence to futility rules was measured as the proportion of patients who stopped therapy among all patients who had an HCV RNA result, which indicated treatment futility at each monitoring interval. A total of 326 patients (65 in the boceprevir group; 261 in the telaprevir group) were eligible for the HCV RNA monitoring analysis, and 134 patients (20 receiving boceprevir and 114 receiving telaprevir) were eligible for the futility rules analysis. There were 1203 HCV RNA assays during the follow-up period. The percentage of patients who were adherent to HCV RNA monitoring during the entire treatment period was 29.2% in the boceprevir group and 32.2% in the telaprevir group. In both treatment groups, adherence to HCV RNA monitoring was highest at the first recommended time interval, followed by a downward trend in the second and third time intervals. Approximately 15% of 134 eligible patients met the futility rules for stopping therapy based on HCV RNA assay results, and 55% of those patients stopped the therapy in accordance with the treatment futility rules. The implementation of RGT was suboptimal in this population of patients with chronic HCV infection; adherence to HCV RNA monitoring guidelines was less than 33%, and adherence to treatment futility rules was less than 50%. Managed care pharmacists should identify strategies to increase the adoption of RGT, which may, in turn, improve patient care and reduce unnecessary expenditures.

A Form 990 Schedule H conundrum: how much of your bad debt might be charity?

PubMed

Bailey, Shari; Franklin, David; Hearle, Keith

2010-04-01

IRS Form 990 Schedule H requires hospitals to estimate the amount of bad debt expense attributable to patients eligible for charity under the hospital's charity care policy. Responses to Schedule H, Part III.A.3 open up the entire patient collection process to examination by the IRS, state officials, and the public. Using predictive analytics can help hospitals efficiently identify charity-eligible patients when answering Part III.A.3.

Impact of Insurance Type on Eligibility for Advanced Heart Failure Therapies and Survival.

PubMed

Hutcheson, Sarah Streeter; Phillips, Victoria; Patzer, Rachel; Smith, Andrew; Vega, J David; Morris, Alanna A

2018-06-15

Medicaid insurance in Georgia provides limited reimbursement for heart transplant (HT) and left ventricular assist devices (LVAD). We examined whether insurance type affects eligibility for and survival after receipt of HT or LVAD. We retrospectively identified patients evaluated for HT/LVAD from 2012 to 2016. We used multivariable logistic and Cox proportional hazards regression to examine the association of insurance type on treatment eligibility and one year survival. Of 569 patients evaluated, 282 (49.6%) had private, 222 (39.0%) had Medicare, and 65 (11.4%) had Medicaid insurance. Patients with Medicaid were younger, more likely to be Black, with fewer medical comorbidities. In adjusted models, Medicare and Medicaid insurance predicted lower odds of eligibility for HT, but did not affect survival after HT. Among those ineligible for HT, Medicaid patients were less likely to receive destination therapy (DT) LVAD (adj OR 0.08, 95% CI 0.01-0.66; P=0.02) and had increased risk of death (adj HR=2.03, 95% CI 1.13 -3.63; p=0.01). Despite younger age and fewer comorbidities, patients with Medicaid insurance are less likely to receive DT LVAD, and have an increased risk of death once deemed ineligible for HT. Medicaid patients in Georgia need improved access to DT LVAD. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Magnetic Resonance Imaging Targeted Biopsy Improves Selection of Patients Considered for Active Surveillance for Clinically Low Risk Prostate Cancer Based on Systematic Biopsies.

PubMed

Ouzzane, Adil; Renard-Penna, Raphaele; Marliere, François; Mozer, Pierre; Olivier, Jonathan; Barkatz, Johann; Puech, Philippe; Villers, Arnauld

2015-08-01

Current selection criteria for active surveillance based on systematic biopsy underestimate prostate cancer volume and grade. We investigated the role of additional magnetic resonance imaging targeted biopsy in reclassifying patients eligible for active surveillance based on systematic biopsy. We performed a study at 2 institutions in a total of 281 men with increased prostate specific antigen. All men met certain criteria, including 1) prebiopsy magnetic resonance imaging, 12-core transrectal systematic biopsy and 2 additional magnetic resonance imaging targeted biopsies of lesions suspicious for cancer during the same sequence as systematic biopsy, and 2) eligibility for active surveillance based on systematic biopsy results. Criteria for active surveillance were prostate specific antigen less than 10 ng/ml, no Gleason grade 4/5, 5 mm or less involvement of any biopsy core and 2 or fewer positive systematic biopsy cores. Patient characteristics were compared between reclassified and nonreclassified groups based on magnetic resonance imaging targeted biopsy results. On magnetic resonance imaging 58% of the 281 patients had suspicious lesions. Magnetic resonance imaging targeted biopsy was positive for cancer in 81 of 163 patients (50%). Of 281 patients 28 (10%) were reclassified by magnetic resonance imaging targeted biopsy as ineligible for active surveillance based on Gleason score in 8, cancer length in 20 and Gleason score plus cancer length in 9. Suspicious areas on magnetic resonance imaging were in the anterior part of the prostate in 15 of the 28 men (54%). Reclassified patients had a smaller prostate volume (37 vs 52 cc) and were older (66.5 vs 63 years) than those who were not reclassified (p < 0.05). Magnetic resonance imaging targeted biopsy reclassified 10% of patients who were eligible for active surveillance based on systematic biopsy. Its incorporation into the active surveillance eligibility criteria may decrease the risk of reclassification to higher stages during followup. Copyright © 2015 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Impact on ART initiation of point-of-care CD4 testing at HIV diagnosis among HIV-positive youth in Khayelitsha, South Africa.

PubMed

Patten, Gabriela E M; Wilkinson, Lynne; Conradie, Karien; Isaakidis, Petros; Harries, Anthony D; Edginton, Mary E; De Azevedo, Virginia; van Cutsem, Gilles

2013-07-04

Despite the rapid expansion of antiretroviral therapy (ART) programmes in developing countries, pre-treatment losses from care remain a challenge to improving access to treatment. Youth and adolescents have been identified as a particularly vulnerable group, at greater risk of loss from both pre-ART and ART care. Point-of-care (POC) CD4 testing has shown promising results in improving linkage to ART care. In Khayelitsha township, South Africa, POC CD4 testing was implemented at a clinic designated for youth aged 12-25 years. We assessed whether there was an associated reduction in attrition between HIV testing, assessment for eligibility and ART initiation. A before-and-after observational study was conducted using routinely collected data. These were collected on patients from May 2010 to April 2011 (Group A) when baseline CD4 count testing was performed in a laboratory and results were returned to the clinic within two weeks. Same-day POC CD4 testing was implemented in June 2011, and data were collected on patients from August 2011 to July 2012 (Group B). A total of 272 and 304 youth tested HIV-positive in Group A and Group B, respectively. Group B patients were twice as likely to have their ART eligibility assessed compared to Group A patients: 275 (90%) vs. 183 (67%) [relative risk (RR)=2.4, 95% CI: 1.8-3.4, p<0.0001]. More patients in World Health Organization (WHO) Stage 1 disease (85% vs. 69%), with CD4 counts≥350 cells/µL (58% vs. 35%) and more males (13% vs. 7%) were detected in Group B. The proportion of eligible patients who initiated ART was 50% and 44% (p=0.6) in Groups B and A, respectively; and 50% and 43% (p=0.5) when restricted to patients with baseline CD4 count≤250 cells/µL. Time between HIV-testing and ART initiation was reduced from 36 to 28 days (p=0.6). POC CD4 testing significantly improved assessment for ART eligibility. The improvement in the proportion initiating ART and the reduction in time to initiation was not significant due to sample size limitations. POC CD4 testing reduced attrition between HIV-testing and assessment of ART eligibility. Strategies to improve uptake of ART are needed, possibly by improving patient support for HIV-positive youth immediately after diagnosis.

Recruit--An Ontology Based Information Retrieval System for Clinical Trials Recruitment.

PubMed

Patrão, Diogo F C; Oleynik, Michel; Massicano, Felipe; Morassi Sasso, Ariane

2015-01-01

Clinical trials are studies designed to assess whether a new intervention is better than the current alternatives. However, most of them fail to recruit participants on schedule. It is hard to use Electronic Health Record (EHR) data to find eligible patients, therefore studies rely on manual assessment, which is time consuming, inefficient and requires specialized training. In this work we describe the design and development of an information retrieval system with the objective of finding eligible patients for cancer trials. The Recruit system has been in use at A. C. Camargo Cancer Center since August/2014 and contains data from more than 500,000 patients and 9 databases. It uses ontologies to integrate data from several sources and represent medical knowledge, which helps enhance results. One can search both in structured data and inside free text reports. The preliminary quality assessments shows excellent recall rates. Recruit proved to be an useful tool for researchers and its modular design could be applied to other clinical conditions and hospitals.

Evaluation of a type 2 diabetes prevention program using a commercial weight management provider for non-diabetic hyperglycemic patients referred by primary care in the UK

PubMed Central

Piper, Carolyn; Marossy, Agnes; Griffiths, Zoe; Adegboye, Amanda

2017-01-01

Objectives To determine if a diabetes prevention program (DPP) delivered by a commercial weight management provider using a UK primary care referral pathway could reduce the progression to type 2 diabetes (T2D) in those diagnosed with non-diabetic hyperglycemia (NDH—being at high risk of developing T2D). Research design This is a quasi-experimental translational research study. Methods 14 primary care practices identified, recruited and referred patients with NDH (fasting plasma glucose ≥5.5 to ≤6.9 mmol/L and/or glycated hemoglobin (HbA1c) ≥42 to 47 mmol/mol (6.0%–6.4%)) and a body mass index (BMI) ≥30 kg/m2 to a DPP. Eligible patients were asked to contact Weight Watchers to book onto their DPP, an intensive lifestyle intervention which included a 90 min activation session followed by the offer of 48 weekly Weight Watchers community group meetings. Patients’ blood tests were repeated by primary care, weight change plus self-reported data was recorded by Weight Watchers. Results 166 patients were referred to the program and 149 were eligible. 79% of eligible patients attended an activation session (117 eligible patients) and 77% started the weekly sessions. The study sample was primarily female (75%), white (90%), with 5% living in the most deprived quintile in the UK. Using intention-to-treat analysis, the DPP resulted in a mean reduction in HbA1c of 2.84 mmol/mol at 12 months (from 43.42±1.28 to 40.58±3.41, p<0.01). 38% of patients returned to normoglycemia and 3% developed T2D at 12 months. There was a mean weight reduction in BMI of 3.2 kg/m2 at 12 months (35.5 kg/m2±5.4 to 32.3 kg/m2±5.2, p<0.01). Conclusion A UK primary care referral route partnered with this commercial weight management provider can deliver an effective DPP. The lifestyle changes and weight loss achieved in the intervention translated into considerable reductions in diabetes risk, with an immediate and significant public health impact. PMID:29225891

Are reports of cognitive testing among older electroconvulsive therapy recipients clinically valid?

PubMed

Plakiotis, Chris; Chin, Loi Fei; O'Connor, Daniel W

2014-03-01

Electroconvulsive therapy (ECT) administration rises in frequency with age, with older depressed adults often showing clinical features predictive of good response. Recent reviews suggest that older people experience few if any long-term cognitive adverse effects after contemporary ECT, despite their increased vulnerability to these. However, the broader clinical validity of research findings is not assured as most studies of ECT-related cognitive effects do not discuss cognitive test nonparticipants. This study examines whether cognitive test participants and nonparticipants are comparable. We recently completed a study of cognition in depressed patients 65 years and older treated with ECT. Only 35% of eligible patients completed neuropsychological testing at 2 time points, the remainder either refusing or unable to consent. To examine whether exclusion of most eligible patients from cognitive testing might have affected the clinical applicability of findings, we compared demographic and clinical characteristics of patients who participated with those who did not based on a subset of patients from our original study. The 2 patient groups differed in several respects. Most notably, nonparticipants were significantly more likely to be involuntary patients; to refuse food and fluids; and to require treatment with a bitemporal or mixed electrode placement. Our findings suggest cognitive test nonparticipants to be more severely psychiatrically unwell than test participants. As their exclusion might bias results and confound understanding of this important ECT-related topic, special mention of participation rates and comparison of participants and nonparticipants is recommended to establish the clinical relevance of future study findings.

Healthcare Staff Wellbeing, Burnout, and Patient Safety: A Systematic Review

PubMed Central

Hall, Louise H.; Johnson, Judith; Watt, Ian; Tsipa, Anastasia; O’Connor, Daryl B.

2016-01-01

Objective To determine whether there is an association between healthcare professionals’ wellbeing and burnout, with patient safety. Design Systematic research review. Data Sources PsychInfo (1806 to July 2015), Medline (1946 to July 2015), Embase (1947 to July 2015) and Scopus (1823 to July 2015) were searched, along with reference lists of eligible articles. Eligibility Criteria for Selecting Studies Quantitative, empirical studies that included i) either a measure of wellbeing or burnout, and ii) patient safety, in healthcare staff populations. Results Forty-six studies were identified. Sixteen out of the 27 studies that measured wellbeing found a significant correlation between poor wellbeing and worse patient safety, with six additional studies finding an association with some but not all scales used, and one study finding a significant association but in the opposite direction to the majority of studies. Twenty-one out of the 30 studies that measured burnout found a significant association between burnout and patient safety, whilst a further four studies found an association between one or more (but not all) subscales of the burnout measures employed, and patient safety. Conclusions Poor wellbeing and moderate to high levels of burnout are associated, in the majority of studies reviewed, with poor patient safety outcomes such as medical errors, however the lack of prospective studies reduces the ability to determine causality. Further prospective studies, research in primary care, conducted within the UK, and a clearer definition of healthcare staff wellbeing are needed. Implications This review illustrates the need for healthcare organisations to consider improving employees’ mental health as well as creating safer work environments when planning interventions to improve patient safety. Systematic Review Registration PROSPERO registration number: CRD42015023340. PMID:27391946

Comparison of Self-Efficacy for Managing Chronic Disease between patients with systemic sclerosis and other chronic conditions: a systematic review.

PubMed

Thombs, Brett D; Kwakkenbos, Linda; Riehm, Kira E; Saadat, Nazanin; Fedoruk, Claire

2017-02-01

The complexity and burden of systemic sclerosis (SSc) pose challenges to developing and sustaining disease management self-efficacy. The objective of this systematic review was to compare scores on a commonly used self-efficacy measure, the Self-Efficacy for Managing Chronic Disease (SEMCD) Scale, between SSc and other diseases. Data sources included the CINAHL, EMBASE, MEDLINE, and Scopus databases, searched through January 25, 2016, and reference lists of included articles and relevant reviews. Studies in any language that reported total SEMCD scores or individual item scores in adult non-psychiatric medical patients were eligible. We identified one eligible non-intervention study of SSc patients (n = 553), 13 other non-intervention studies, and 21 studies with pre-intervention data for patients enrolled in a self-management program or a trial of a program. Of 13 non-intervention studies with published total score means in cancer, cardiovascular disease, Parkinson's disease, spinal cord injuries, organ transplant candidates and recipients, dialysis, and lupus, SEMCD scores were statistically significantly lower (poorer self-efficacy) in SSc than 6 other disease samples, not significantly different from 6, and significantly higher than lupus patients. Compared to 18 studies of patients in self-management programs or trials with published total score means, SSc patients were similar or lower than 9 samples and significantly higher than 9 samples. Compared to patients with other diseases not enrolled in programs to improve self-efficacy, SSc patients report lower self-efficacy scores than most patient groups. Rigorously tested self-care interventions designed to meet the unique needs of patients with SSc are needed.

The Society for Vascular Surgery's objective performance goals for lower extremity revascularization are not generalizable to many open surgical bypass patients encountered in contemporary surgical practice.

PubMed

Saraidaridis, Julia T; Ergul, Emel; Patel, Virendra I; Stone, David H; Cambria, Richard P; Conrad, Mark F

2015-08-01

In 2009, the Society for Vascular Surgery (SVS) established objective performance goals (OPG) for lower extremity bypass (LEB) in patients with critical limb ischemia (CLI) based on pooled data from previously performed prospective studies in an effort to provide a benchmark and historical control for future trials. However, patients with a prosthetic conduit and end-stage renal disease were excluded from this cohort. In contemporary practice, many patients do not meet the criteria for SVS OPG inclusion, making generalization of the SVS OPG difficult. The goal of this study was to establish safety and efficacy measures for patients who were excluded from the original SVS OPG analysis. All patients who underwent LEB for CLI in the Vascular Study Group of New England (VSGNE) from 2003 to 2013 were identified. Patients were stratified into OPG-eligible and non-OPG-eligible cohorts. Outcomes included 30-day major adverse limb events, 30-day major adverse cardiovascular events, 1-year survival, and 1-year freedom from amputation. The SVS OPG methodology was used to create new performance goals for the non-OPG-eligible patients. We identified 3609 patients: 2360 OPG (65%) vs 1249 non-OPG (35%), and overall results were stratified as a function of OPG status. The 30-day major adverse limb event rate was 5.0% (5.5% non-OPG vs 4.4% OPG; P = .34), and the 30-day major adverse cardiovascular event rate was 7.3% (9.2% non-OPG vs 6.2% OPG; P = .001). At 1 year, survival was 84% (75.9% non-OPG vs 88.3% OPG; P < .001), and freedom from amputation was 86.9% (80.9% non-OPG vs 90.1% OPG; P < .001). The SVS OPG were attainable in New England for the population of patients who would have met SVS OPG study cohort inclusion criteria. However, 35% of the patients who underwent LEB for CLI in the last 10 years fell outside of these criteria by having end-stage renal disease or requiring a prosthetic conduit. We therefore suggest new benchmarks for these high-risk populations. Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Restrictive vs Liberal Blood Transfusion for Acute Upper Gastrointestinal Bleeding: Rationale and Protocol for a Cluster Randomized Feasibility Trial

PubMed Central

Jairath, Vipul; Kahan, Brennan C.; Gray, Alasdair; Doré, Caroline J.; Mora, Ana; Dyer, Claire; Stokes, Elizabeth A.; Llewelyn, Charlotte; Bailey, Adam A.; Dallal, Helen; Everett, Simon M.; James, Martin W.; Stanley, Adrian J.; Church, Nicholas; Darwent, Melanie; Greenaway, John; Le Jeune, Ivan; Reckless, Ian; Campbell, Helen E.; Meredith, Sarah; Palmer, Kelvin R.; Logan, Richard F.A.; Travis, Simon P.L.; Walsh, Timothy S.; Murphy, Michael F.

2013-01-01

Acute upper gastrointestinal bleeding (AUGIB) is the commonest reason for hospitalization with hemorrhage in the UK and the leading indication for transfusion of red blood cells (RBCs). Observational studies suggest an association between more liberal RBC transfusion and adverse patient outcomes, and a recent randomised trial reported increased further bleeding and mortality with a liberal transfusion policy. TRIGGER (Transfusion in Gastrointestinal Bleeding) is a pragmatic, cluster randomized trial which aims to evaluate the feasibility and safety of implementing a restrictive versus liberal RBC transfusion policy in adult patients admitted with AUGIB. The trial will take place in 6 UK hospitals, and each centre will be randomly allocated to a transfusion policy. Clinicians throughout each hospital will manage all eligible patients according to the transfusion policy for the 6-month trial recruitment period. In the restrictive centers, patients become eligible for RBC transfusion when their hemoglobin is < 8 g/dL. In the liberal centers patients become eligible for transfusion once their hemoglobin is < 10 g/dL. All clinicians will have the discretion to transfuse outside of the policy but will be asked to document the reasons for doing so. Feasibility outcome measures include protocol adherence, recruitment rate, and evidence of selection bias. Clinical outcome measures include further bleeding, mortality, thromboembolic events, and infections. Quality of life will be measured using the EuroQol EQ-5D at day 28, and the costs associated with hospitalization for AUGIB in the UK will be estimated. Consent will be sought from participants or their representatives according to patient capacity for use of routine hospital data and day 28 follow up. The study has ethical approval for conduct in England and Scotland. Results will be analysed according to a pre-defined statistical analysis plan and disseminated in peer reviewed publications to relevant stakeholders. The results of this study will inform the feasibility and design of a phase III randomized trial. PMID:23706959

Lifetime costs for peritoneal dialysis and hemodialysis in patients in Taiwan.

PubMed

Kao, Tze-Wah; Chang, Yu-Yin; Chen, Pau-Chung; Hsu, Chih-Cheng; Chang, Yu-Kang; Chang, Yu-Hung; Lee, Lukas Jyuhn-Hsiarn; Wu, Kwan-Dun; Tsai, Tun-Jun; Wang, Jung-Der

2013-01-01

This study compared the lifetime costs for peritoneal dialysis (PD) and hemodialysis (HD) patients in Taiwan. Using the National Health Insurance (NHI) database of all end-stage renal disease patients on maintenance dialysis registered from July 1997 to December 2005, we matched eligible PD patients with eligible HD patients on age, sex, and diabetes status. The matched patients were followed until 31 December 2006. Patients were excluded if they were less than 18 years of age, had been diagnosed with cancer before dialysis, or had been dialyzed at centers or clinics other than hospitals. Outcomes-including life expectancy, total lifetime costs, and costs per life-year paid by the NHI-were estimated and compared. The 3136 pairs of matched PD and HD patients had a mean age of 53.2 ± 15.4 years. The total lifetime cost for PD patients (US$139 360 ± US$8 336) was significantly lower than that for HD patients (US$185 235 ± US$9 623, p < 0.001). Except for patients with diabetes (who had a short life expectancy), the total lifetime cost was significantly lower for PD patients than for HD patients regardless of sex and age (p < 0.01). In Taiwan, the total lifetime costs paid by the NHI were lower for PD than for HD patients.

An explorative analysis of the recruitment of patients to a randomised controlled trial in adolescents with dental anxiety.

PubMed

Wide Boman, Ulla; Broberg, Anders G; Krekmanova, Larisa; Staberg, Marie; Svensson, Carina; Robertson, Agneta

2014-01-01

Randomised controlled trials (RCTs) are considered to provide the most reliable evidence on the efficacy of interventions. The aim of this study was to describe the recruitment process of an RCT study set up to evaluate a Cognitive Behavioural Therapy (CBT) intervention programme for adolescent patients with dental anxiety (DA). The participants were recruited from a consecutive sample of adolescent patients (12-19 yrs old) referred for DA to a specialised pediatric dentistry clinic. Age, gender, and reason for referral were recorded for the possible eligible patients as part of the drop-out analysis of the recruitment process. Participants were then randomized to the intervention (CBT integrated with dental treatment) or control (adapted dental treatment) condition. In the recruitment process, 138 possible eligible patients met inclusion criteria, of these 55 were enrolled, 44 declined participation and 39 patients were excluded.The patients enrolled in the RCT did not differ from the non-participants with regard to age, gender or cause of referral. As a result of difficulties in the recruitment process, the study period was extended. The considerable proportion of non-participants as evident from the recruitment process may pose a threat to the external validity of the clinical trial. From a clinical perspective, the reasons for the lack of motivation to participate in behavioural interventions and the failure to appear warrant further investigation.

TRANSFER FROM PEDIATRIC TO ADULT ENDOCRINOLOGY.

PubMed

Jones, Marybeth R; Robbins, Brett W; Augustine, Marilyn; Doyle, Jackie; Mack-Fogg, Jean; Jones, Heather; White, Patience H

2017-07-01

Adult and pediatric endocrinologists share responsibility for the transition of youth with type 1 diabetes from pediatric to adult healthcare. This study aimed to increase successful transfers to adult care in subspecialty practices by establishing a systematic health care transition (HCT) process. Providers from the adult and pediatric endocrinology divisions at the University of Rochester Medical Center met monthly to customize and integrate the Six Core Elements (6CEs) of HCT into clinical workflows. Young adult patients with type 1 diabetes having an outpatient visit during a 34-month pre-post intervention period were eligible (N = 371). Retrospective chart review was performed on patients receiving referrals to adult endocrinology (n = 75) to obtain (1) the proportion of patients explicitly tracked during transfer from the pediatric to adult endocrinology practice, (2) the providers' documentation of the use of the 6CEs, and (3) the patients' diabetes control and healthcare utilization during the transition period. The percent of eligible patients with type 1 diabetes who were explicitly tracked in their transfer more than doubled compared to baseline (11% vs. 27% of eligible patients; P<.01). Pediatric providers started to use transition readiness assessments and create medical summaries, and adult providers increased closed-loop communication with pediatric providers after a patient's first adult visit. Glycemic control and healthcare utilization remained stable. Successful implementation of the 6CEs into pediatric and adult subspecialty practices can result in improvements of planned transfers of pediatric patients with type 1 diabetes to adult subspecialty providers. 6CEs = six core elements; AYA = adolescent and young adult; DKA = diabetic ketoacidosis; ED = emergency department; HbA1c = hemoglobin A1c; HCT = health care transition.

Physicians declining patient enrollment in a critical care trial: a case study in thromboprophylaxis.

PubMed

Cook, D; Arabi, Y; Ferguson, N; Heels-Ansdell, D; Freitag, A; McDonald, E; Clarke, F; Keenan, S; Pagliarello, G; Plaxton, W; Herridge, M; Karachi, T; Vallance, S; Cade, J; Crozier, T; Alves da Silva, S; Costa Filho, R; Brandao, N; Watpool, I; McArdle, T; Hollinger, G; Mandourah, Y; Al-Hazmi, M; Zytaruk, N; Adhikari, N K J

2013-12-01

To analyze the frequency, rationale and determinants of attending physicians requesting that their eligible patients not be approached for participation in a thromboprophylaxis trial. Research personnel in 67 centers prospectively documented eligible non-randomized patients due to physicians declining to allow their patients to be approached. In 67 centers, 3,764 patients were enrolled, but 1,460 eligible patients had no consent encounter. For 218 (14.9 %) of these, attending physicians requested that their patients not be approached. The most common reasons included a high risk of bleeding (31.2 %) related to fear of heparin bioaccumulation in renal failure, the presence of an epidural catheter, peri-operative status or other factors; specific preferences for thromboprophylaxis (12.4 %); morbid obesity (9.6 %); uncertain prognosis (6.4 %); general discomfort with research (3.7 %) and unclear reasons (17.0 %). Physicians were more likely to decline when approached by less experienced research personnel; considering those with[10 years of experience as the reference category, the odds ratios (OR) for physician refusals to personnel without trial experience was 10.47 [95 % confidence interval (CI) 2.19-50.02] and those with less than 10 years experience was 1.72 (95 % CI 0.61-4.84). Physicians in open rather than closed units were more likely to decline (OR 4.26; 95 % CI 1.27-14.34). Refusals decreased each year of enrollment compared to the pilot phase. Tracking, analyzing, interpreting and reporting the rates and reasons for physicians declining to allow their patients to be approached for enrollment provides insights into clinicians' concerns and attitudes to trials. This information can encourage physician communication and education, and potentially enhance efficient recruitment.

Impact of a Lung Cancer Screening Counseling and Shared Decision-Making Visit.

PubMed

Mazzone, Peter J; Tenenbaum, Amanda; Seeley, Meredith; Petersen, Hilary; Lyon, Christina; Han, Xiaozhen; Wang, Xiao-Feng

2017-03-01

Lung cancer screening is a complex balance of benefits and harms. A counseling and shared decision-making visit has been mandated to assist patients with the decision about participation in screening. To our knowledge, the impact of this visit on patient understanding and decisions has not been studied. We developed a centralized counseling and shared decision-making visit for our lung cancer screening program. The visit included confirmation of eligibility for screening, education supported by a narrated slide show, individualized risk assessment with a decision aid, time for answering questions, and data collection. We surveyed consecutive patients prior to the visit, immediately after the visit, and 1 month after the visit to determine the impact of the visit on their knowledge. Twenty-three of 423 patients (5.4%) who had a visit did not proceed to the screening CT scan. One hundred twenty-five consecutive patients completed the initial survey, 122 completed the postvisit survey, and 113 completed the 1-month follow-up survey. Prior to the visit, the patients had a poor level of understanding about the age and smoking eligibility criteria (8.8% and 13.6% correct, respectively) and the benefits and harms of screening (55.2% and 38.4% correct, respectively). There was a significant improvement in knowledge noted after the visit for all questions (P = .03 to P < .0001). Knowledge waned by the 1-month follow-up but remained higher than it was before the visit. A centralized counseling and shared decision-making visit impacts the patient's knowledge about the eligibility criteria, benefits, and harms of lung cancer screening with LDCT, helping patients make value-based decisions. Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

Implementation of a quality improvement programme to support advance care planning in five hospitals across a health region.

PubMed

Schofield, G; Kreeger, L; Meyer, M; Swann, D; Wijeratne, A; Wood, J; Stone, P

2015-03-01

Advance care planning (ACP) can help patients with a terminal illness to prepare for the end of their lives. This report describes a regional service improvement initiative to increase the identification of hospital inpatients at this stage in their illnesses and to increase the number of such patients who are offered the opportunity to start the process of ACP. Data were collected prospectively over a 7 month period from four acute hospital trusts and a specialist cancer centre in the South-West London region. Each unit identified a specific patient population who were screened for eligibility to engage in the process of ACP. Data concerning the reasons for eligibility, the suitability for discussion and the various reasons why patients did not complete the process, were recorded. Over a 7 month period 1980 patients were screened and 559 (28.2%) were found to be potentially eligible for an ACP discussion. Of these 227/559 (40.6%) were deemed suitable for a discussion by medical staff. The majority of these patients (195/227; 86%) were offered the opportunity to undergo ACP discussions and 144/195 (73.8%) agreed to begin the process of ACP. This report shows that a targeted approach can result in increased uptake in the number of patients who engage in ACP. However, systematic identification of potentially eligible patients requires a significant investment of clinical time and resources. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Comparison of Survival Outcomes Among Cancer Patients Treated In and Out of Clinical Trials

PubMed Central

2014-01-01

Background Clinical trials test the efficacy of a treatment in a select patient population. We examined whether cancer clinical trial patients were similar to nontrial, “real-world” patients with respect to presenting characteristics and survival. Methods We reviewed the SWOG national clinical trials consortium database to identify candidate trials. Demographic factors, stage, and overall survival for patients in the standard arms were compared with nontrial control subjects selected from the Surveillance, Epidemiology, and End Results program. Multivariable survival analyses using Cox regression were conducted. The survival functions from aggregate data across all studies were compared separately by prognosis (≥50% vs <50% average 2-year survival). All statistical tests were two-sided. Results We analyzed 21 SWOG studies (11 good prognosis and 10 poor prognosis) comprising 5190 patients enrolled from 1987 to 2007. Trial patients were younger than nontrial patients (P < .001). In multivariable analysis, trial participation was not associated with improved overall survival for all 11 good-prognosis studies but was associated with better survival for nine of 10 poor-prognosis studies (P < .001). The impact of trial participation on overall survival endured for only 1 year. Conclusions Trial participation was associated with better survival in the first year after diagnosis, likely because of eligibility criteria that excluded higher comorbidity patients from trials. Similar survival patterns between trial and nontrial patients after the first year suggest that trial standard arm outcomes are generalizable over the long term and may improve confidence that trial treatment effects will translate to the real-world setting. Reducing eligibility criteria would improve access to clinical trials. PMID:24627276

Nonadherence in the era of severe asthma biologics and thermoplasty

PubMed Central

Lee, Joy; Tay, Tunn Ren; Radhakrishna, Naghmeh; Hore-Lacy, Fiona; Mackay, Anna; Hoy, Ryan; Dabscheck, Eli; O'Hehir, Robyn; Hew, Mark

2018-01-01

Nonadherence to inhaled preventers impairs asthma control. Electronic monitoring devices (EMDs) can objectively measure adherence. Their use has not been reported in difficult asthma patients potentially suitable for novel therapies, i.e. biologics and bronchial thermoplasty. Consecutive patients with difficult asthma were assessed for eligibility for novel therapies. Medication adherence, defined as taking >75% of prescribed doses, was assessed by EMD and compared with standardised clinician assessment over an 8-week period. Among 69 difficult asthma patients, adherence could not be analysed in 13, due to device incompatibility or malfunction. Nonadherence was confirmed in 20 out of 45 (44.4%) patients. Clinical assessment of nonadherence was insensitive (physician 15%, nurse 28%). Serum eosinophils were higher in nonadherent patients. Including 11 patients with possible nonadherence (device refused or not returned) increased the nonadherence rate to 31 out of 56 (55%) patients. Severe asthma criteria were fulfilled by 59 out of 69 patients. 47 were eligible for novel therapies, with confirmed nonadherence in 16 out of 32 (50%) patients with EMD data; including seven patients with possible nonadherence increased the nonadherence rate to 23 out of 39 (59%). At least half the patients eligible for novel therapies were nonadherent to preventers. Nonadherence was often undetectable by clinical assessments. Preventer adherence must be confirmed objectively before employing novel severe asthma therapies. PMID:29519922

Behavior change, acceptance, and coping flexibility in highly distressed patients with rheumatic diseases: feasibility of a cognitive-behavioral therapy in multimodal rehabilitation.

PubMed

Vriezekolk, Johanna E; Geenen, Rinie; van den Ende, Cornelia H M; Slot, Helma; van Lankveld, Wim G J M; van Helmond, Toon

2012-05-01

To describe the development and feasibility of the integration of a cognitive-behavioral therapy (CBT) within a multimodal rehabilitation program for highly distressed patients with rheumatic diseases. Development included the detailed specification of the theoretical and empirical-based underpinnings of the CBT and the comprehensive description of its design and content. Feasibility was assessed by percentage of eligible patients, attrition and attendance rates, and patient satisfaction. The developed CBT component seeks to decrease psychological distress and improve activities and participation across multiple life domains by accomplishing behavior change, acceptance, and coping flexibility. Motivational interviewing was applied to endorse patients' own reasons to change. Forty percent (35/87) of the eligible patients were admitted to the program. Attendance rate (>95%) was high. Patient satisfaction ranged from 6.8 to 8.0 (10-point scale). Integrating CBT within a multimodal rehabilitation program is feasible. An acceptable proportion of the intended patient sample is eligible and patient's attendance and satisfaction is high. Patients with impaired physical and psychosocial functioning despite adequate medical treatment pose a great challenge. Their treatment outcome may be improved by screening and selecting highly distressed patients and offering them a CBT embedded in multimodal rehabilitation program. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Physician-patient communication in rheumatology: a systematic review.

PubMed

Georgopoulou, Sofia; Prothero, Louise; D'Cruz, David P

2018-05-01

The nature of physician-patient interaction can have a significant impact on patient outcomes through information-sharing and disease-specific education that can enhance patients' active involvement in their care. The aim of this systematic review was to examine all the empirical evidence pertaining to aspects of physician-patient communication and its impact on patient outcomes. A systematic search of five electronic databases (MEDLINE, PsycINFO, EMBASE, CINAHL, and Web of Science) was undertaken from earliest record to December 2016. Studies were eligible if they: (1) included adult participants (18 years or over) with a diagnosis of a rheumatic condition; (2) were of quantitative, qualitative or mixed methods design; (4) were surveys, observational and interventional studies; (5) were published in the English language; and (6) reported findings on either various physician-patient communication aspects alone or in combination with physical and psychological outcomes. Searches identified 455 papers. Following full-text retrieval and assessment for eligibility and quality, ten studies were included in the review; six quantitative, one mixed methods, and three qualitative papers. Higher levels of trust in the physician and active patient participation in the medical consultation were linked to lower disease activity, better global health, less organ damage accrual, greater treatment satisfaction with fewer side effects from the medication, more positive beliefs about control over the disease, and about current and future health. Future research could focus on the design and implementation of interventions incorporating communications skills and patient-education training.

Dyadic recruitment in complementary therapy studies: experience from a clinical trial of caregiver-delivered reflexology.

PubMed

Holmstrom, Amanda J; Wyatt, Gwen K; Sikorskii, Alla; Musatics, Catherine; Stolz, Emily; Havener, Neala

2016-02-01

As home-based care continues to be a growing trend in health care, involvement of friend and family caregivers in the management of illness becomes essential. However, before nurses can prepare caregivers to engage in various types of care, an evidence base needs to be established via randomized controlled trials (RCTs). Research suggests that recruiting cancer patients and their friend or family caregivers into RCTs presents challenges. The purpose of this paper is to illustrate the barriers to recruitment of patient-caregiver dyads into a RCT of caregiver-delivered reflexology and to recommend strategies to address such barriers. This paper reports on a nurse-directed RCT that involved recruitment efforts unique to a caregiver-delivered reflexology protocol for advanced-stage breast cancer patients. Ineligibility due to caregiver-related reasons, consent among eligible patients (out of 551 approached patients), and reasons for refusal were analyzed. Almost one-third of patients were found to be ineligible due to the lack of a caregiver to participate with them and provide this form of social support. Among eligible patients, the consent rate for this dyadic study is much lower than that of previous RCTs of reflexologist-delivered reflexology that enrolled just patients, not dyads. Implications for nursing practice and research include addressing the need for greater social support for patients and strategies for problem-solving refusal reasons during study enrollment. Copyright © 2015 Elsevier Inc. All rights reserved.

Mobile tablet-based therapies following stroke: A systematic scoping review of administrative methods and patient experiences

PubMed Central

Ramsay, Tim; Johnson, Dylan; Dowlatshahi, Dar

2018-01-01

Background and purpose Stroke survivors are often left with deficits requiring rehabilitation to recover function and yet, many are unable to access rehabilitative therapies. Mobile tablet-based therapies (MTBTs) may be a resource-efficient means of improving access to timely rehabilitation. It is unclear what MTBTs have been attempted following stroke, how they were administered, and how patients experienced the therapies. The review summarizes studies of MTBTs following stroke in terms of administrative methods and patient experiences to inform treatment feasibility. Methods Articles were eligible if they reported the results of an MTBT attempted with stroke participants. Six research databases were searched along with grey literature sources, trial registries, and article references. Intervention administration details and patient experiences were summarized. Results The search returned 903 articles of which 23 were eligible for inclusion. Most studies were small, observational, and enrolled chronic stroke patients. Interventions commonly targeted communication, cognition, or fine-motor skills. Therapies tended to be personalized based on patient deficits using commercially available applications. The complexity of therapy instructions, fine-motor requirements, and unreliability of internet or cellular connections were identified as common barriers to tablet-based care. Conclusions Stroke patients responded positively to MTBTs in both the inpatient and home settings. However, some support from therapists or caregivers may be required for patients to overcome barriers to care. Feasibility studies should continue to identify the administrative methods that minimize barriers to care and maximize patient adherence to prescribed therapy regiments. PMID:29360872

Identification of chronic myeloid leukemia patients treated with imatinib who are potentially eligible for treatment discontinuation by assessing real-life molecular responses on the international scale in a EUTOS-certified lab.

PubMed

Heinrichs, Amélie; Dessars, Barbara; El Housni, Hakim; Pluymers, Wim; Peeters, Karen; Benghiat, Fleur S; Heimann, Pierre

2018-04-01

A retrospective study was performed to describe molecular responses (MR) on the international scale (IS) in patients with chronic myeloid leukemia (CML) treated with imatinib in routine clinical practice in Belgium and to identify patients potentially eligible for treatment discontinuation. The analysis included 116 patients with CML in chronic phase at treatment centers sending blood samples for molecular follow-up to a single EUTOS-certified laboratory. IS MR from the last patient visit between October 2014 and April 2015 were retrospectively collected. Most patients (93.1%) had an IS MR corresponding to an optimal response per European LeukemiaNet 2013 guidelines; 53.4% (62/116) of patients were in deep molecular responses ≥MR 4.5 at their last visit (mean treatment duration: 91.0 months) among whom 36.2% (42/116) had been receiving imatinib for >5.8 years and 26.7% (31/116) for >8 years (margins of error: 8.74% and 8.05%, respectively). These patients would likely have the highest chance of staying in treatment-free remission (TFR) upon discontinuation, based on published TFR trial data. Although our study only provides a snapshot in time of a patient's last MR reported, without precise information regarding MR duration, the study settings could nevertheless support the feasibility of attempting TFR outside clinical trials in the future. Copyright © 2018 Elsevier Ltd. All rights reserved.

Demographics and health care seeking behavior of Singaporean women with chronic constipation: implications for therapeutic management

PubMed Central

Gwee, Kok Ann; Setia, Sajita

2012-01-01

Introduction Chronic constipation is significantly more prevalent in women than men in Singapore. We carried out a survey to study patient demographics, symptom prevalence, healthcare-seeking behavior, and patient satisfaction with available treatment options in women with chronic constipation. Methods Responses were collected predominantly via a web-based survey from a panel representative of Singapore’s women population. Eligibility was established using a nine-question screener. Results A total of 1006 invited females took part in an online screener survey, of which 911 respondents did not meet the eligibility requirements for the chronic constipation survey. Of the total panelists consenting to participate (via both online and face-to-face interviews), 100 women met eligibility requirements and took the 22-question survey. Eligible respondents were skewed to younger patients but well mixed in terms of marital status. The majority of them were not keen on doing exercise and were working women, especially white collar females. The majority complained of straining and hard stools as the most common constipation symptoms (88% and 80% respectively) and rated constipation symptoms as severe or moderate. On average, respondents experienced constipation symptoms for 6 to 7 months in the last year. In more than two-thirds of respondents, constipation symptoms were frequent (at least 1 in 3 times). Most of the patients had attempted to treat constipation themselves and 80% had tried laxatives before visiting the doctor. Satisfaction with fiber supplements and laxatives was average and many of the users were not satisfied with their effect. Ineffectiveness and prolonged time taken for the treatment to take effect were the most common reasons for dissatisfaction. Nearly all respondents (97%) were interested in considering alternative prescriptive medication that is proven more effective. Conclusion Chronic constipation symptoms in women are often severe and bothersome, and many patients are dissatisfied with available treatment options primarily because of lack of efficacy. PMID:22505828

Demographics and health care seeking behavior of Singaporean women with chronic constipation: implications for therapeutic management.

PubMed

Gwee, Kok Ann; Setia, Sajita

2012-01-01

Chronic constipation is significantly more prevalent in women than men in Singapore. We carried out a survey to study patient demographics, symptom prevalence, healthcare-seeking behavior, and patient satisfaction with available treatment options in women with chronic constipation. Responses were collected predominantly via a web-based survey from a panel representative of Singapore's women population. Eligibility was established using a nine-question screener. A total of 1006 invited females took part in an online screener survey, of which 911 respondents did not meet the eligibility requirements for the chronic constipation survey. Of the total panelists consenting to participate (via both online and face-to-face interviews), 100 women met eligibility requirements and took the 22-question survey. Eligible respondents were skewed to younger patients but well mixed in terms of marital status. The majority of them were not keen on doing exercise and were working women, especially white collar females. The majority complained of straining and hard stools as the most common constipation symptoms (88% and 80% respectively) and rated constipation symptoms as severe or moderate. On average, respondents experienced constipation symptoms for 6 to 7 months in the last year. In more than two-thirds of respondents, constipation symptoms were frequent (at least 1 in 3 times). Most of the patients had attempted to treat constipation themselves and 80% had tried laxatives before visiting the doctor. Satisfaction with fiber supplements and laxatives was average and many of the users were not satisfied with their effect. Ineffectiveness and prolonged time taken for the treatment to take effect were the most common reasons for dissatisfaction. Nearly all respondents (97%) were interested in considering alternative prescriptive medication that is proven more effective. Chronic constipation symptoms in women are often severe and bothersome, and many patients are dissatisfied with available treatment options primarily because of lack of efficacy.

Effectiveness versus efficacy trials in COPD: how study design influences outcomes and applicability.

PubMed

Woodcock, Ashley; Boucot, Isabelle; Leather, David A; Crawford, Jodie; Collier, Susan; Bakerly, Nawar Diar; Hilton, Emma; Vestbo, Jørgen

2018-02-01

Guidelines for chronic obstructive pulmonary disease (COPD) management are based largely on results from double-blind randomised controlled trials (RCTs) of efficacy. These trials have high internal validity and test whether a drug is efficacious, but they are conducted in highly selected populations that may differ significantly from patients with COPD seen in routine practice.We compared the baseline characteristics, healthcare use and outcomes between the Salford Lung Study (SLS), an open-label effectiveness RCT, with six recent large-scale efficacy RCTs. We also calculated the proportion of SLS patients who would have been eligible for inclusion in an efficacy RCT by applying the inclusion criteria used in efficacy trials of combination treatments.SLS patients were older, included more females and more current smokers, had more comorbidities (including asthma), and had more often experienced exacerbations prior to inclusion. In the SLS, rates of moderate or severe exacerbations, incidence of overall serious adverse events (SAEs), and SAEs of pneumonia were more frequent. A maximum of 30% of patients enrolled in the SLS would have been eligible for a phase IIIa regulatory exacerbation study.Patients in large COPD efficacy RCTs have limited representativeness compared with an effectiveness trial. This should be considered when interpreting efficacy RCT outcomes and their inclusion into guidelines. Copyright ©ERS 2018.

Multiple Myeloma: Clinical Updates From the American Society of Hematology Annual Meeting, 2017.

PubMed

Terpos, Evangelos

2018-05-01

The novel clinical data for myeloma that were presented in the 2017 Annual Meeting of the American Society of Hematology are summarized here. Studies with curative approach (CESAR) or prolonging progression-free survival (CENTAURUS) for patients with high-risk smoldering multiple myeloma (SMM) are described. Updated data from large phase III studies for patients with newly diagnosed MM (NDMM) who are eligible for autologous stem cell transplantation (ASCT) (EMN02, MRC XI) are described, along with the results of studies using novel anti-myeloma drug combinations for induction, consolidation, and maintenance as first-line therapy. The role of minimal residual disease for patients with MM is also discussed. We also present the results of novel phase III studies in patients with NDMM who are not eligible for ASCT (ALCYONE) and new data for their treatment. Recent updates of important studies in the field of relapsed/refractory MM (ASPIRE, POLLUX) along with novel immunotherapy approaches (anti-BCMA monoclonal antibodies, CART cells) are also reported. Finally, levofloxacin prophylaxis reduces febrile episodes and death events in NDMM, whereas 2 doses of high-dose influenza vaccine seem to maintain higher rates of seroprotection compared with those who received standard vaccination. All these data provide the basis for possible changes in the way we manage myeloma in the near future trying to "cure" the disease in many patients. Copyright © 2018 Elsevier Inc. All rights reserved.

Why take the chance? A qualitative grounded theory study of nocturnal haemodialysis recipients who decline kidney transplantation

PubMed Central

Rosenthal, Meagen M; Molzahn, Anita E; Chan, Christopher T; Cockfield, Sandra L; Kim, S Joseph; Pauly, Robert P

2016-01-01

Objective The objective of this study was to examine the factors that influence decision-making to forgo transplantation in favour of remaining on nocturnal haemodialysis (NHD). Design A grounded theory approach using in-depth telephone interviewing was used. Setting Participants were identified from 2 tertiary care renal programmes in Canada. Participants The study participants were otherwise eligible patients with end-stage renal disease who have opted to remain off of the transplant list. A total of 7 eligible participants were interviewed. 5 were male. The mean age was 46 years. Analysis A constant comparative method of analysis was used to identify a core category and factors influencing the decision-making process. Results In this grounded theory study of people receiving NHD who refused kidney transplantation, the core category of ‘why take a chance when things are going well?’ was identified, along with 4 factors that influenced the decision including ‘negative past experience’, ‘feeling well on NHD’, ‘gaining autonomy’ and ‘responsibility’. Conclusions This study provides insight into patients' thought processes surrounding an important treatment decision. Such insights might help the renal team to better understand, and thereby respect, patient choice in a patient-centred care paradigm. Findings may also be useful in the development of education programmes addressing the specific concerns of this population of patients. PMID:27194322

Oxaliplatin in combination with protracted-infusion fluorouracil and radiation: report of a clinical trial for patients with esophageal cancer.

PubMed

Khushalani, Nikhil I; Leichman, Cynthia Gail; Proulx, Gary; Nava, Hector; Bodnar, Lisa; Klippenstein, Donald; Litwin, Alan; Smith, Judy; Nava, Enriqueta; Pendyala, Lakshmi; Smith, Patrick; Greco, William; Berdzik, Joanne; Douglass, Harold; Leichman, Lawrence

2002-06-15

To identify a dose and schedule of oxaliplatin (OXP) to be safely administered in combination with protracted-infusion (PI) fluorouracil (5-FU) and external-beam radiation therapy (XRT) for patients with primary esophageal carcinoma (EC). Eligibility included therapeutically naïve EC patients with clinical disease stages II, III, or IV. Initial doses and schedules for cycle 1 consisted of OXP 85 mg/m(2) on days 1, 15, and 29; PI 5-FU 180 mg/m(2) for 24 hours for 35 days; and XRT 1.8 Gy in 28 fractions starting on day 8. At completion of cycle 1, eligible patients could undergo an operation or begin cycle 2 without XRT. Postoperative patients were eligible for cycle 2. Stage IV patients were allowed three cycles in the absence of disease progression. OXP and 5-FU increases were based on dose-limiting toxicity (DLT) encountered in cohorts of three consecutive patients. Thirty-eight eligible patients received therapy: 22 noninvasively staged as IV and 16 noninvasively staged as II and III. Thirty-six patients completed cycle 1, 29 patients started cycle 2, and 24 patients completed cycle 2. The combined-modality therapy was well tolerated, but DLT prevented OXP and 5-FU escalation. No grade 4 hematologic toxicity was noted. Eleven grade 3 and two grade 4 clinical toxicities were noted in eight patients. After cycle 1, 29 patients (81%) had no cancer in the esophageal mucosa. Thirteen patients underwent an operation with intent to resect the esophagus; five patients (38%) exhibited pathologic complete responses. OXP 85 mg/m(2) on days 1, 15, and 29 administered with PI 5-FU and XRT is safe, tolerable, and seems effective against primary EC. The role of OXP in multimodality regimens against EC deserves further evaluation.

Why don't patients enroll in hospice? Can we do anything about it?

PubMed

Vig, Elizabeth K; Starks, Helene; Taylor, Janelle S; Hopley, Elizabeth K; Fryer-Edwards, Kelly

2010-10-01

United States hospice organizations aim to provide quality, patient-centered end-of-life care to patients in the last 6 months of life, yet some of these organizations observe that some hospice-eligible patients who are referred to hospice do not initially enroll. To identify reasons that eligible patients do not enroll in hospice (phase 1). To identify strategies used by hospice providers to address these reasons (phase 2). Semi-structured interviews analyzed using content analysis. In phase 1, we interviewed 30 patients and/or family members of patients who had a hospice admissions visit, but who did not enroll. In phase 2, we interviewed 19 hospice staff and national experts. In phase 1, we asked participants to describe the patient's illness, the hospice referral, and why they had not enrolled. We performed a content analysis to characterize their reasons for not enrolling in hospice. In phase 2, we enrolled hospice admissions staff and hospice experts. We asked them to describe how they would respond to each reason (from phase 1) during an admissions visit with a potential new hospice patient. We identified key phrases, and summarized their recommendations. Reasons that patients hadn't enrolled fell into three broad categories: patient/family perceptions (e.g., "not ready"), hospice specific issues (e.g., variable definitions of hospice-eligible patients), and systems issues (e.g., concerns about continuity of care). Hospice staff/experts had encountered each reason, and offered strategies at the individual and organizational level for responding. In hopes of increasing hospice enrollment among hospice-eligible patients, non-hospice and hospice clinicians may want to adopt some of the strategies used by hospice staff/experts for talking about hospice with patients/families and may want to familiarize themselves with the differences between hospice organizations in their area. Hospices may want to reconsider their admission policies and procedures in light of patients' and families' perceptions and concerns.

Has dementia research lost its sense of reality? A descriptive analysis of eligibility criteria of Dutch dementia research protocols.

PubMed

Jongsma, K R; van Bruchem-Visser, R L; van de Vathorst, S; Mattace Raso, F U S

2016-06-01

A substantial proportion of dementia patients are excluded from research participation, while for extrapolation of the study findings, it is important that the research population represents the patient population. The aim of this study is to provide an analysis of dementia research and its exclusion criteria in order to get a clearer picture whether the research participants represent the general dementia population. Dementia studies registered at ToetsingOnline.nl between 2006-2015 were analysed. Study characteristics, funding and eligibility criteria were described and analysed using a standardised score sheet. The search yielded 103 usable study protocols. The number of trials has increased over the years, and 35% of the studies were industry-financed. Alzheimer's disease was the most researched type of dementia (84%). In observational studies the most frequently observed exclusion criterion is a neurological condition, while in drug studies and other intervention studies this is a somatic condition. Of all protocols, 86% had at least one exclusion criterion concerning comorbidity. Most studies focused on mild or moderate dementia (78%). Our study has shown that the distribution of dementia research over the different subtypes of dementia does not correspond with the prevalence of these subtypes in clinical practice. The research population in the protocols is not representative of the larger patient population. A greater number of dementia patients could derive benefit from the conducted research if the research agenda were more closely aligned with disease prevalence. A better representation of all dementia patients in research will help to meet the needs of these patients.

Capacity and equity in cardiac rehabilitation in the eastern region: good and bad news.

PubMed

Jennings, S; Carey, D

2004-01-01

To document current baseline eligibility for Phase 3 cardiac rehabilitation (CR) and the capacity to meet this need in hospitals in the Eastern Regional Health Authority. Information on the eligible population and the capacity for CR was collected in all nine hospitals retrospectively (February-March 2001). Forty-seven per cent of eligible patients were invited to participate with only two-thirds attending. Completion rates were very high (89%) in attenders. Age and health board area were significant independent predictors of being invited to CR. Gender was not independent of age. Fifty-three per cent of the need for this service was met by capacity in the region's nine hospitals in 2000 rising to 59% in 2002. Many eligible patients are not invited to CR. Lack of capacity is a problem. Among the invited, non-participation is a factor. Inequity in age and inter-hospital variation in invitation is noted.

Estimating the real-world effects of expanding antiretroviral treatment eligibility: Evidence from a regression discontinuity analysis in Zambia

PubMed Central

Sikazwe, Izukanji; Wa Mwanza, Mwanza; Savory, Theodora; Sikombe, Kombatende; Somwe, Paul; Roy, Monika; Padian, Nancy

2018-01-01

Background Although randomized trials have established the clinical efficacy of treating all persons living with HIV (PLWHs), expanding treatment eligibility in the real world may have additional behavioral effects (e.g., changes in retention) or lead to unintended consequences (e.g., crowding out sicker patients owing to increased patient volume). Using a regression discontinuity design, we sought to assess the effects of a previous change to Zambia’s HIV treatment guidelines increasing the threshold for treatment eligibility from 350 to 500 cells/μL to anticipate effects of current global efforts to treat all PLWHs. Methods and findings We analyzed antiretroviral therapy (ART)-naïve adults who newly enrolled in HIV care in a network of 64 clinics operated by the Zambian Ministry of Health and supported by the Centre for Infectious Disease Research in Zambia (CIDRZ). Patients were restricted to those enrolling in a narrow window around the April 1, 2014 change to Zambian HIV treatment guidelines that raised the CD4 threshold for treatment from 350 to 500 cells/μL (i.e., August 1, 2013, to November 1, 2014). Clinical and sociodemographic data were obtained from an electronic medical record system used in routine care. We used a regression discontinuity design to estimate the effects of this change in treatment eligibility on ART initiation within 3 months of enrollment, retention in care at 6 months (defined as clinic attendance between 3 and 9 months after enrollment), and a composite of both ART initiation by 3 months and retention in care at 6 months in all new enrollees. We also performed an instrumental variable (IV) analysis to quantify the effect of actually initiating ART because of this guideline change on retention. Overall, 34,857 ART-naïve patients (39.1% male, median age 34 years [IQR 28–41], median CD4 268 cells/μL [IQR 134–430]) newly enrolled in HIV care during this period; 23,036 were analyzed after excluding patients around the threshold to allow for clinic-to-clinic variations in actual guideline uptake. In all newly enrolling patients, expanding the CD4 threshold for treatment from 350 to 500 cells/μL was associated with a 13.6% absolute increase in ART initiation within 3 months of enrollment (95% CI, 11.1%–16.2%), a 4.1% absolute increase in retention at 6 months (95% CI, 1.6%–6.7%), and a 10.8% absolute increase in the percentage of patients who initiated ART by 3 months and were retained at six months (95% CI, 8.1%–13.5%). These effects were greatest in patients who would have become newly eligible for ART with the change in guidelines: a 43.7% increase in ART initiation by 3 months (95% CI, 37.5%–49.9%), 13.6% increase in retention at six months (95% CI, 7.3%–20.0%), and a 35.5% increase in the percentage of patients on ART at 3 months and still in care at 6 months [95% CI, 29.2%–41.9%). We did not observe decreases in ART initiation or retention in patients not directly targeted by the guideline change. An IV analysis found that initiating ART in response to the guideline change led to a 37.9% (95% CI, 28.8%–46.9%) absolute increase in retention in care. Limitations of this study include uncertain generalizability under newer models of care, lack of laboratory data (e.g., viral load), inability to account for earlier stages in the HIV care cascade (e.g., HIV testing and linkage), and potential for misclassification of eligibility status or outcome. Conclusions In this study, guidelines raising the CD4 threshold for treatment from 350 to 500 cells/μL were associated with a rapid rise in ART initiation as well as enhanced retention among newly treatment-eligible patients, without negatively impacting patients with lower CD4 levels. These data suggest that health systems in Zambia and other high-prevalence settings could substantially enhance engagement even among those with high CD4 levels (i.e., above 500 cells/μL) by expanding treatment without undermining existing care standards. PMID:29870531

Estimating the real-world effects of expanding antiretroviral treatment eligibility: Evidence from a regression discontinuity analysis in Zambia.

PubMed

Mody, Aaloke; Sikazwe, Izukanji; Czaicki, Nancy L; Wa Mwanza, Mwanza; Savory, Theodora; Sikombe, Kombatende; Beres, Laura K; Somwe, Paul; Roy, Monika; Pry, Jake M; Padian, Nancy; Bolton-Moore, Carolyn; Holmes, Charles B; Geng, Elvin H

2018-06-01

Although randomized trials have established the clinical efficacy of treating all persons living with HIV (PLWHs), expanding treatment eligibility in the real world may have additional behavioral effects (e.g., changes in retention) or lead to unintended consequences (e.g., crowding out sicker patients owing to increased patient volume). Using a regression discontinuity design, we sought to assess the effects of a previous change to Zambia's HIV treatment guidelines increasing the threshold for treatment eligibility from 350 to 500 cells/μL to anticipate effects of current global efforts to treat all PLWHs. We analyzed antiretroviral therapy (ART)-naïve adults who newly enrolled in HIV care in a network of 64 clinics operated by the Zambian Ministry of Health and supported by the Centre for Infectious Disease Research in Zambia (CIDRZ). Patients were restricted to those enrolling in a narrow window around the April 1, 2014 change to Zambian HIV treatment guidelines that raised the CD4 threshold for treatment from 350 to 500 cells/μL (i.e., August 1, 2013, to November 1, 2014). Clinical and sociodemographic data were obtained from an electronic medical record system used in routine care. We used a regression discontinuity design to estimate the effects of this change in treatment eligibility on ART initiation within 3 months of enrollment, retention in care at 6 months (defined as clinic attendance between 3 and 9 months after enrollment), and a composite of both ART initiation by 3 months and retention in care at 6 months in all new enrollees. We also performed an instrumental variable (IV) analysis to quantify the effect of actually initiating ART because of this guideline change on retention. Overall, 34,857 ART-naïve patients (39.1% male, median age 34 years [IQR 28-41], median CD4 268 cells/μL [IQR 134-430]) newly enrolled in HIV care during this period; 23,036 were analyzed after excluding patients around the threshold to allow for clinic-to-clinic variations in actual guideline uptake. In all newly enrolling patients, expanding the CD4 threshold for treatment from 350 to 500 cells/μL was associated with a 13.6% absolute increase in ART initiation within 3 months of enrollment (95% CI, 11.1%-16.2%), a 4.1% absolute increase in retention at 6 months (95% CI, 1.6%-6.7%), and a 10.8% absolute increase in the percentage of patients who initiated ART by 3 months and were retained at six months (95% CI, 8.1%-13.5%). These effects were greatest in patients who would have become newly eligible for ART with the change in guidelines: a 43.7% increase in ART initiation by 3 months (95% CI, 37.5%-49.9%), 13.6% increase in retention at six months (95% CI, 7.3%-20.0%), and a 35.5% increase in the percentage of patients on ART at 3 months and still in care at 6 months [95% CI, 29.2%-41.9%). We did not observe decreases in ART initiation or retention in patients not directly targeted by the guideline change. An IV analysis found that initiating ART in response to the guideline change led to a 37.9% (95% CI, 28.8%-46.9%) absolute increase in retention in care. Limitations of this study include uncertain generalizability under newer models of care, lack of laboratory data (e.g., viral load), inability to account for earlier stages in the HIV care cascade (e.g., HIV testing and linkage), and potential for misclassification of eligibility status or outcome. In this study, guidelines raising the CD4 threshold for treatment from 350 to 500 cells/μL were associated with a rapid rise in ART initiation as well as enhanced retention among newly treatment-eligible patients, without negatively impacting patients with lower CD4 levels. These data suggest that health systems in Zambia and other high-prevalence settings could substantially enhance engagement even among those with high CD4 levels (i.e., above 500 cells/μL) by expanding treatment without undermining existing care standards.

What fluids are given during air ambulance treatment of patients with trauma in the UK, and what might this mean for the future? Results from the RESCUER observational cohort study

PubMed Central

Naumann, David N; Hancox, James M; Raitt, James; Smith, Iain M; Crombie, Nicholas; Doughty, Heidi; Perkins, Gavin D; Midwinter, Mark J

2018-01-01

Objectives We investigated how often intravenous fluids have been delivered during physician-led prehospital treatment of patients with hypotensive trauma in the UK and which fluids were given. These data were used to estimate the potential national requirement for prehospital blood products (PHBP) if evidence from ongoing trials were to report clinical superiority. Setting The Regional Exploration of Standard Care during Evacuation Resuscitation (RESCUER) retrospective observational study was a collaboration between 11 UK air ambulance services. Each was invited to provide up to 5 years of data and total number of taskings during the same period. Participants Patients with hypotensive trauma (systolic blood pressure <90 mm Hg or absent radial pulse) attended by a doctor. Primary and secondary outcome measures The primary outcome was the number of patients with hypotensive trauma given prehospital fluids. Secondary outcomes were types and volumes of fluids. These data were combined with published data to estimate potential national eligibility for PHBP. Results Of 29 037 taskings, 729 (2.5%) were for patients with hypotensive trauma attended by a physician. Half were aged 21–50 years; 73.4% were male. A total of 537 out of 729 (73.7%) were given fluids. Five hundred and ten patients were given a single type of fluid; 27 received >1 type. The most common fluid was 0.9% saline, given to 486/537 (90.5%) of patients who received fluids, at a median volume of 750 (IQR 300–1500) mL. Three per cent of patients received PHBP. Estimated projections for patients eligible for PHBP at these 11 services and in the whole UK were 313 and 794 patients per year, respectively. Conclusions One in 40 air ambulance taskings were manned by physicians to retrievepatients with hypotensive trauma. The most common fluid delivered was 0.9% saline. If evidence justifies universal provision of PHBP, approximately 800 patients/year would be eligible in the UK, based on our data combined with others published. Prospective investigations are required to confirm or adjust these estimations. PMID:29362272

Eligibility for medical thromboprophylaxis based on risk-factor weights, and clinical thrombotic event rates.

PubMed

Millar, J Alasdair; Lett, Joanne E; Bagley, Leonard J; Densie, Ian K

2012-04-16

To measure eligibility for medical thromboprophylaxis using two Australasian guidelines - the Australia and New Zealand Working Party Guidelines [WPG] and the National Health and Medical Research Council Guidelines [NHMRCG]) - and proposed new guidelines based on risk-factor weights; and to measure the incidence of clinical venous thromboembolism (VTE) events in medical patients ("ensuing VTE"). Prospective case-note audit in an acute medical ward of Southland Hospital, a regional hospital in Invercargill, New Zealand, among all 595 patients who were discharged consecutively from 21 November 2010 to 7 March 2011. Of these, 245 were excluded on clinical grounds or because they were under the care of the authors. The primary outcome was eligibility for prophylaxis under each guideline. Secondary outcomes included incidence of ensuing VTEs, use of thromboprophylaxis, drug acquisition costs with each guideline, and bedside practicability of a guideline based on risk-factor weights. Nineteen per cent of patients were eligible under the new guidelines, compared with 80%, 88% and 36% under the WPG and two interpetations of the NHMRCG, respectively. One patient had an ensuing VTE. The new guideline had lower drug acquisition costs and was suitable for bedside use. Clinical VTE events are rare in medical patients, and medical VTE thromboprophylaxis needs to be more focused. The new guideline has performance characteristics th@satisfy this need.

Activity of Sorafenib in Recurrent Ovarian Cancer and Primary Peritoneal Carcinomatosis: A Gynecologic Oncology Group Trial

PubMed Central

Matei, Daniela; Sill, Michael W.; Lankes, Heather A.; DeGeest, Koen; Bristow, Robert E.; Mutch, David; Yamada, S. Diane; Cohn, David; Calvert, Valerie; Farley, John; Petricoin, Emanuel F.; Birrer, Michael J.

2011-01-01

Purpose Sorafenib is a kinase inhibitor targeting Raf and other kinases (ie, vascular endothelial growth factor receptor [VEGFR], platelet-derived growth factor receptor [PDGFR], Flt3, and c-KIT). This study assessed its activity and tolerability in patients with recurrent ovarian cancer (OC) or primary peritoneal carcinomatosis (PPC). Methods This open-label, multi-institutional, phase II study used a two-stage design. Eligible patients had persistent or recurrent OC/PPC after one to two prior cytotoxic regimens, and they experienced progression within 12 months of platinum-based therapy. Treatment consisted of sorafenib 400 mg orally twice per day. Primary end points were progression-free survival (PFS) at 6 months and toxicity by National Cancer Institute criteria. Secondary end points were tumor response and duration of PFS and overall survival. Biomarker analyses included measurement of ERK and b-Raf expression in tumors and phosphorylation of ERK (pERK) in peripheral-blood lymphocytes (PBLs) before and after 1 month of treatment. Results Seventy-three patients were enrolled, of which 71 were eligible. Fifty-nine eligible patients (83%) had measurable disease, and 12 (17%) had detectable disease. Significant grade 3 or 4 toxicities included the following: rash (n = 7), hand-foot syndrome (n = 9), metabolic (n = 10), GI (n = 3), cardiovascular (n = 2), and pulmonary (n = 2). Only patients with measurable disease were used to assess efficacy. Fourteen survived progression free for at least 6 months (24%; 90% CI, 15% to 35%). Two patients had partial responses (3.4%; 90% CI, 1% to 10%); 20 had stable disease; 30 had progressive disease; and seven could not have their tumor assessed. ERK and b-Raf were expressed in all tumors. Exploratory analyses indicated that pERK in post-treatment PBL specimens was associated with PFS. Conclusion Sorafenib has modest antitumor activity in patients with recurrent OC, but the activity was at the expense of substantial toxicity. PMID:21098323

Anticipated changes in reimbursements for US outpatient emergency department encounters after health reform.

PubMed

Galarraga, Jessica E; Pines, Jesse M

2014-04-01

We study how reimbursements to emergency departments (EDs) for outpatient visits may be affected by the insurance coverage expansion of the Patient Protection and Affordable Care Act as previously uninsured patients gain coverage either through the Medicaid expansion or through health insurance exchanges. We conducted a secondary analysis of data (2005 to 2010) from the Medical Expenditure Panel Survey. We specified multiple linear regression models to examine differences in the payments, charges, and reimbursement ratios by insurance category. Comparisons were made between 2 groups to reflect likely movements in insurance status after the Patient Protection and Affordable Care Act implementation: (1) the uninsured who will be Medicaid eligible afterward versus Medicaid insured, and (2) the uninsured who will be Medicaid ineligible afterward versus the privately insured. From 2005 to 2010, as a percentage of total ED charges, outpatient ED encounters for Medicaid beneficiaries reimbursed 17% more than for uninsured individuals who will become Medicaid eligible after Patient Protection and Affordable Care Act implementation: 40.0% versus 34.0%, mean absolute difference=5.9%, 95% confidence interval 5.7% to 6.2%. During the same period, the privately insured reimbursed 39% more than for uninsured individuals who will not be Medicaid eligible after Patient Protection and Affordable Care Act implementation: 54.0% versus 38.8%, mean absolute difference=15.2%, 95% confidence interval 12.8% to 17.6%. Assuming historical reimbursement patterns remain after Patient Protection and Affordable Care Act implementation, outpatient ED encounters could reimburse considerably more for both the previously uninsured patients who will obtain Medicaid insurance and for those who move into private insurance products through health insurance exchanges. Although our study does provide insight into the future, multiple factors will ultimately influence reimbursements after implementation of the act. Copyright © 2013 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

Comprehensive Hearing Aid Intervention at a Free Subspecialty Clinic.

PubMed

Wertz, Aileen P; Mannarelli, Gregory; Shuman, Andrew G; McKean, Erin L

2017-09-01

Providing a model of a comprehensive free audiologic program may assist other health care professionals in developing their own similar program. To describe the structure, feasibility, and outcomes of a free subspecialty clinic providing hearing aids to develop a paradigm for other programs interested in implementing similar projects. A retrospective case series was conducted from September 1, 2013, through March 31, 2016. In a partnership between a free independent clinic for indigent patients and an academic medical center, 54 indigent patients were referred to the clinic for audiograms. A total of 50 of these patients had results of audiograms available for review and were therefore included in the study; 34 of these 50 patients were determined to be eligible for hearing aid fitting based on audiometric results. Free audiometric testing, hearing aid fitting, and hearing aid donation. The number of hearing aids donated, number of eligible patients identified, number of patients fitted with hearing aids, and work effort (hours) and start-up costs associated with implementation of this program were quantified. A total of 54 patients (31 women [57.4%] and 23 men [42.6%]; median age, 61 years; range, 33-85 years) had audiograms performed, and 84 hearing aids were donated to the program. The patients were provided with free audiograms, hearing aid molds, and hearing aid programming, as well as follow-up appointments to ensure continued proper functioning of their hearing aids. Since 2013, a total of 34 patients have been determined to be eligible for the free program and were offered hearing aid services. Of these, 20 patients (59%) have been fitted or are being fitted with free hearing aids. The value of services provided is estimated to be $2260 per patient. It is feasible to provide free, comprehensive audiologic care, including hearing aids and fitting, in a well-established, free clinic model. The opportunity for indigent patients to use hearing aids at minimal personal cost is a major step forward in improving access to high-quality care.

Youth Alcohol Use and Dating Abuse Victimization and Perpetration: A Test of the Relationships at the Daily Level in a Sample of Pediatric Emergency Department Patients Who Use Alcohol

ERIC Educational Resources Information Center

Rothman, Emily F.; Stuart, Gregory L.; Winter, Michael; Wang, Na; Bowen, Deborah J.; Bernstein, Judith; Vinci, Robert

2012-01-01

Objective: This study retrospectively examined the daily-level associations between youth alcohol use and dating abuse (DA) victimization and perpetration for a 6-month period. Method: Timeline Followback (TLFB) interview data were collected from 397 urban emergency department patients, ages 17 to 21 years. Patients were eligible if they reported…

Effects of librarian-provided services in healthcare settings: a systematic review

PubMed Central

Perrier, Laure; Farrell, Ann; Ayala, A Patricia; Lightfoot, David; Kenny, Tim; Aaronson, Ellen; Allee, Nancy; Brigham, Tara; Connor, Elizabeth; Constantinescu, Teodora; Muellenbach, Joanne; Epstein, Helen-Ann Brown; Weiss, Ardis

2014-01-01

Objective To assess the effects of librarian-provided services in healthcare settings on patient, healthcare provider, and researcher outcomes. Materials and methods Medline, CINAHL, ERIC, LISA (Library and Information Science Abstracts), and the Cochrane Central Register of Controlled Trials were searched from inception to June 2013. Studies involving librarian-provided services for patients encountering the healthcare system, healthcare providers, or researchers were eligible for inclusion. All librarian-provided services in healthcare settings were considered as an intervention, including hospitals, primary care settings, or public health clinics. Results Twenty-five articles fulfilled our eligibility criteria, including 22 primary publications and three companion reports. The majority of studies (15/22 primary publications) examined librarians providing instruction in literature searching to healthcare trainees, and measured literature searching proficiency. Other studies analyzed librarian-provided literature searching services and instruction in question formulation as well as the impact of librarian-provided services on patient length of stay in hospital. No studies were found that investigated librarians providing direct services to researchers or patients in healthcare settings. Conclusions Librarian-provided services directed to participants in training programs (eg, students, residents) improve skills in searching the literature to facilitate the integration of research evidence into clinical decision-making. Services provided to clinicians were shown to be effective in saving time for health professionals and providing relevant information for decision-making. Two studies indicated patient length of stay was reduced when clinicians requested literature searches related to a patient's case. PMID:24872341

Influenza vaccination, inverse care and homelessness: cross-sectional survey of eligibility and uptake during the 2011/12 season in London.

PubMed

Story, Alistair; Aldridge, Robert W; Gray, Tat; Burridge, Stan; Hayward, Andrew C

2014-01-16

Influenza vaccination eligibility and uptake among homeless adults has not been previously assessed in the UK. This cross-sectional survey aimed to measure the proportion of homeless people visited by an NHS outreach service (Find and Treat) who were eligible for and had received vaccination during 2011/12. A cross-sectional survey was carried out in 27 separate homeless hostels, day centres and drug services in London between July and August in 2012. Eligibility for the survey was by virtue of being in attendance at one of 27 venues visited by Find and Treat. No specific exclusion criteria were used. 455 clients took part in the survey out of 592 approached (76.9%). A total of 190 homeless people (41.8%; 95% CI: 34.5,50.5) were eligible for influenza vaccination. In those aged 16-64, eligibility due to clinical risk factors was 38.9% (95% CI: 31.5,48.2). Uptake of vaccination in homeless 16-64 year olds with a clinical risk factor during the 2011/12 influenza season was 23.7% (95% CI: 19.8,28.3) compared to national levels of 53.2% (excluding pregnant women). In those aged over 65, uptake was 42.9% (95% CI: 16.7,100.0) compared with 74.0% nationally. This study demonstrates that the homeless population have high levels of chronic health problems predisposing them to severe complications of influenza, but vaccine uptake levels that are less than half those seen among eligible GP patient groups in England. It provides a clear example of the health inequalities and inverse care law that impact this population. The results of this study provide strong justification for intensifying efforts to ensure homeless people have access to influenza vaccination.

Survival Outcome After Stereotactic Body Radiation Therapy and Surgery for Stage I Non-Small Cell Lung Cancer: A Meta-Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zheng, Xiangpeng; Schipper, Matthew; Department of Biostatistics, the University of Michigan, Ann Arbor, Michigan

Purpose: This study compared treatment outcomes of stereotactic body radiation therapy (SBRT) with those of surgery in stage I non-small cell lung cancer (NSCLC). Methods and Materials: Eligible studies of SBRT and surgery were retrieved through extensive searches of the PubMed, Medline, Embase, and Cochrane library databases from 2000 to 2012. Original English publications of stage I NSCLC with adequate sample sizes and adequate SBRT doses were included. A multivariate random effects model was used to perform a meta-analysis to compare survival between treatments while adjusting for differences in patient characteristics. Results: Forty SBRT studies (4850 patients) and 23 surgerymore » studies (7071 patients) published in the same period were eligible. The median age and follow-up duration were 74 years and 28.0 months for SBRT patients and 66 years and 37 months for surgery patients, respectively. The mean unadjusted overall survival rates at 1, 3, and 5 years with SBRT were 83.4%, 56.6%, and 41.2% compared to 92.5%, 77.9%, and 66.1% with lobectomy and 93.2%, 80.7%, and 71.7% with limited lung resections. In SBRT studies, overall survival improved with increasing proportion of operable patients. After we adjusted for proportion of operable patients and age, SBRT and surgery had similar estimated overall and disease-free survival. Conclusions: Patients treated with SBRT differ substantially from patients treated with surgery in age and operability. After adjustment for these differences, OS and DFS do not differ significantly between SBRT and surgery in patients with operable stage I NSCLC. A randomized prospective trial is warranted to compare the efficacy of SBRT and surgery.« less

Interventions for acute stroke management in Africa: a systematic review of the evidence.

PubMed

Baatiema, Leonard; Chan, Carina K Y; Sav, Adem; Somerset, Shawn

2017-10-24

The past decades have witnessed a rapid evolution of research on evidence-based acute stroke care interventions worldwide. Nonetheless, the evidence-to-practice gap in acute stroke care remains variable with slow and inconsistent uptake in low-middle income countries (LMICs). This review aims to identify and compare evidence-based acute stroke management interventions with alternative care on overall patient mortality and morbidity outcomes, functional independence, and length of hospital stay across Africa. This review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline. An electronic search was conducted in six databases comprising MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Web of Science, Academic Search Complete and Cochrane Library for experimental and non-experimental studies. Eligible studies were abstracted into evidence tables and their methodological quality appraised using the Joanna Briggs Institute checklist. Data were analysed and presented narratively with reference to observed differences in patient outcomes, reporting p values and confidence intervals for any possible relationship. Initially, 1896 articles were identified and 37 fully screened. Four non-experimental studies (three cohort and one case series studies) were included in the final review. One study focused on the clinical efficacy of a stroke unit whilst the remaining three reported on thrombolytic therapy. The results demonstrated a reduction in patient deaths attributed to stroke unit care and thrombolytic therapy. Thrombolytic therapy was also associated with reductions in symptomatic intracerebral haemorrhage (SICH). However, the limited eligible studies and methodological limitations compromised definitive conclusions on the extent of and level of efficacy of evidence-based acute stroke care interventions across Africa. Evidence from this review confirms the widespread assertion of low applicability and uptake of evidence-based acute stroke care in LMICs. Despite the limited eligible studies, the overall positive patient outcomes following such interventions demonstrate the applicability and value of evidence-based acute stroke care interventions in Africa. Health policy attention is thus required to ensure widespread applicability of such interventions for improved patients' outcomes. The review findings also emphasises the need for further research to unravel the reasons for low uptake. PROSPERO CRD42016051566.

BRIEF REPORT: The Role of Point of Care Testing for Patients with Acute Pharyngitis

PubMed Central

Atlas, Steven J; McDermott, Steven M; Mannone, Carol; Barry, Michael J

2005-01-01

Background There is no consensus favoring a particular strategy for evaluating patients with pharyngitis. Objective To compare a clinical decision aid and a rapid office-based point of care (POC) test with routine culture for group A β-hemolytic streptococcus (GAS). Design Prospective observational study. Participants Among 179 patients enrolled, 150 were eligible and 148 had POC testing and cultures initially performed. Measurements An encounter form included eligibility criteria, clinical information based upon the Centor rule, and treatment provided. Sensitivity and specificity of POC test compared to routine culture for GAS. Results Thirty-eight patients (25.7%) had a positive GAS culture. The POC test was 92.1% sensitive (95% confidence interval [CI] 80% to 98%) and 100% specific (95% CI 97% to 100%). Although the Centor rule did not adequately discriminate among symptomatic patients with or without GAS (receiver operating curve area 0.63), the 3 patients with a false-negative POC test had a Centor score of less than 2. Among patients with a negative POC test, 26% initially received antibiotics. Conclusions For patients with a Centor score of ≥2, a POC test was highly sensitive for GAS. Future studies should confirm these results and assess whether implementation of POC testing as part of a local practice guideline can decrease variability in testing and treatment. PMID:16050888

Lack of experience of intravenous thrombolysis for acute ischaemic stroke does not influence the proportion of patients treated

PubMed Central

Kobayashi, Adam; Skowronska, Marta; Litwin, Tomasz; Czlonkowska, Anna

2007-01-01

Objectives To determine the eligibility of patients with ischaemic stroke admitted to the 2nd Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland, for intravenous thrombolysis; to identify the major exclusions and assess whether organisational changes in the in‐hospital stroke pathway and informative campaign in the local community and medical services can increase the number of patients treated; and to establish whether lack of previous experience with thrombolytic treatment or trials is predictive of the low proportion of patients treated. Methods A survey of the database of patients with stroke admitted during the first 30 months after the introduction of intravenous thrombolysis for acute ischaemic stroke was conducted to search for all eligible patients. This included patients admitted within 2 h of symptom onset (assuming a 1 h door‐to‐needle time), age <80 years, National Institute of Health Stroke Scale (NIHSS) Score of 5–22, seizures at onset, platelet count >100 000/ml, glycaemia 50–400 mg/dl and international normalised ratio (INR) <1.6. The number of eligible patients was compared with the number actually treated. Results 745 patients with acute ischaemic stroke were admitted during the study period. 18.4% were admitted within 2 h of symptom onset, 71% were aged <80 years, 55.4% had an NIHSS score between 5 and 22, 96.1% had INR <1.6, 98.9% had a platelet count >100 000/ml, 99.4% had blood glucose concentrations of 50–400 mg/dl and 97.4% had no seizures at onset. After adjusting for all inclusion criteria, 7.1% of the patients were found to be potentially eligible and 8.7% were actually treated (p = 0.25). Of the 65 treated patients, 63.1% were independent after 3 months, 16.9% died and none had a symptomatic intracranial haemorrhage. Conclusions The proportion of patients with ischaemic stroke treated with intravenous thrombolysis in a previously inexperienced centre was not lower than in other centres and in countries where this treatment has been provided for a longer period of time. The number of patients treated was higher than that estimated mainly owing to organisational changes introduced in our centre, allowing treatment of those admitted between 2 and 3 h after symptom onset. PMID:17251612

An analysis of clinical outcomes and costs of a long term acute care hospital.

PubMed

Votto, John J; Scalise, Paul J; Barton, Randall W; Vogel, Cristine A

2011-01-01

Compare clinical outcomes and costs in a study group of long-term acute care hospital (LTCH) patients with a control group of LTCH-eligible patients in an acute care hospital. LTCHs were created to provide post-acute care services not available at other post-acute settings. This is based on the premise that these patients would otherwise have stayed at acute care hospitals as high-cost outliers. The LTCH hospital is intended to deliver care to patients more efficiently, however, there are little documented clinical and financial data regarding the comparative clinical outcomes and costs for patients. Retrospective medical and billing record review of patients from the following groups: (1) LTCH study comprising patients admitted directly from an acute care hospital to the study LTCH and discharged from the LTCH from September 2004 through August 2006; (2) a control group of LTCH-eligible, medically complex patients treated and discharged from an acute care hospital in FY 2002. The control group was selected from approximately 500 patients who had at least one of the ten most common principle diagnosis DRGs of the study LTCH with >30-day length of stay at the referring hospital and met NALTH admitting guidelines. Discharge disposition is an important outcome measure of the quality of care of medically complex patients. The in-hospital mortality rate trended lower and home discharge was 3 times higher for the LTCH study group than for the control group. As a possible result, SNF discharge of LTCH patients was approximately half that of the control group. Both mean patient cost per day and mean total cost per patient were significantly higher in the control group than in the LTCH study group. The patients in the LTCH study group had both better clinical outcomes and lower cost of care than the control group.

Association of Expanded Medicaid Coverage With Hospital Length of Stay After Injury.

PubMed

Holzmacher, Jeremy L; Townsend, Kerry; Seavey, Caleb; Gannon, Stephanie; Schroeder, Mary; Gondek, Stephen; Collins, Lois; Amdur, Richard L; Sarani, Babak

2017-10-01

The expansion of Medicaid eligibility under the Affordable Care Act is a state-level decision that affects how patients with traumatic injury (trauma patients) interact with locoregional health care systems. Washington, DC; Maryland; and Virginia represent 3 unique payer systems with liberal, moderate, and no Medicaid expansion, respectively, under the Affordable Care Act. Characterizing the association of Medicaid expansion with hospitalization after injury is vital in the disposition planning for these patients. To determine the association between expanded Medicaid eligibility under the Affordable Care Act and duration of hospitalization after injury. This retrospective cohort study included patients admitted from Virginia, Maryland, and Washington, DC, to a single level I trauma center. Data were collected from January 1, 2013, through March 6, 2016, in Virginia and Washington, DC, and from May 1, 2013, through March 6, 2016, in Maryland. All patients with Medicare or Medicaid coverage and all uninsured patients were included. Patients with private insurance, patients with severe head or pelvic injuries, and those who died during hospitalization were excluded. Hospital length of stay (LOS) and whether its association with patient insurance status varied by state of residence. A total of 2314 patients (1541 men [66.6%] and 773 women [33.4%]; mean [SD] age, 52.9 [22.8] years) were enrolled in the study. The uninsured rate in the Washington, DC, cohort (190 of 1699 [11.2%]) was significantly lower compared with rates in the Virginia (141 of 296 [47.6%]) or the Maryland (106 of 319 [33.2%]) cohort (P < .001). On multivariate regression controlling for injury severity and demographic variables, the difference in LOS for Medicaid vs non-Medicaid recipients varied significantly by state. For Medicaid recipients, mean LOS in Washington, DC, was significantly shorter (2.57 days; 95% CI, 2.36-2.79 days) than in Maryland (3.51 days; 95% CI, 2.81-4.38 days; P = .02) or Virginia (3.9 days; 95% CI, 2.79-5.45 days; P = .05). Expanded Medicaid eligibility is associated with shorter hospital LOS in mildly injured Medicaid recipients.

Assessing barriers to adherence in routine clinical care for pediatric kidney transplant patients.

PubMed

Varnell, Charles D; Rich, Kristin L; Nichols, Melissa; Dahale, Devesh; Goebel, Jens W; Pai, Ahna L H; Hooper, David K; Modi, Avani C

2017-11-01

Patient-identified barriers to immunosuppressive medications are associated with poor adherence and negative clinical outcomes in transplant patients. Assessment of adherence barriers is not part of routine post-transplant care, and studies regarding implementing such a process in a reliable way are lacking. Using the Model for Improvement and PDSA cycles, we implemented a system to identify adherence barriers, including patient-centered design of a barriers assessment tool, identification of eligible patients, clear roles for clinic staff, and creating a culture of non-judgmental discussion around adherence. We performed time-series analysis of our process measure. Secondary analyses examined the endorsement and concordance of adherence barriers between patient-caregiver dyads. After three methods of testing, the most reliable delivery system was an EHR-integrated tablet that alerted staff of patient eligibility for assessment. Barriers were endorsed by 35% of caregivers (n=85) and 43% of patients (n=60). The most frequently patient-endorsed barriers were forgetting, poor taste, and side effects. Caregivers endorsed forgetting and side effects. Concordance between patient-caregiver dyads was fair (k=0.299). Standardized adherence barriers assessment is feasible in the clinical care of pediatric kidney transplant patients. Features necessary for success included automation, redundant systems with designated staff to identify and mitigate failures, aligned reporting structures, and reliable measurement approaches. Future studies will examine whether barriers predict clinical outcomes (eg, organ rejection, graft loss). © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Turning frequency in adult bedridden patients to prevent hospital-acquired pressure ulcer: A scoping review.

PubMed

Jocelyn Chew, H-S; Thiara, Emelia; Lopez, Violeta; Shorey, Shefaly

2018-04-01

The aim of this study was to identify current research on turning frequencies of adult bed-bound patients and inform future turning practices for hospitals based on evidence-based practice. We undertook a scoping review framework that provided a transparent and systematic methodology using 8 electronic databases (CINAHL, PubMed, Cochrane Library, ScienceDirect, PsycINFO, Scopus, ProQuest, and Web of Science) to identify articles published from 2000 to 2016. Articles were included if they focused on the prevention of hospital-acquired pressure ulcers related to the frequency of turning or repositioning of bed-bound patients. Literature search and data extraction were performed independently by 3 authors. The study followed the PRISMA guidelines. In total, 911 articles were identified, of which 10 were eligible. Of the eligible articles, 8 studies could not reach a conclusion on the effective frequency of turning and duration for repositioning patients to prevent the development of pressure ulcers. Only 2 studies found significant differences among the intervention and control groups. Results regarding turning and repositioning schedules are inconclusive; however, the topic needs further exploration to improve the outdated guidelines surrounding pressure ulcer prevention. This may, in turn, make the work of nurses more efficient and make treatment cost-effective for both the patients and the hospitals. © 2017 Medicalhelplines.com Inc and John Wiley & Sons Ltd.

Risk factors of significant pain syndrome 90 days after minor thoracic injury: trajectory analysis.

PubMed

Daoust, Raoul; Emond, Marcel; Bergeron, Eric; LeSage, Natalie; Camden, Stéphanie; Guimont, Chantal; Vanier, Laurent; Chauny, Jean-Marc

2013-11-01

The objective was to identify the risk factors of clinically significant pain at 90 days in patients with minor thoracic injury (MTI) discharged from the emergency department (ED). A prospective, multicenter, cohort study was conducted in four Canadian EDs from November 2006 to November 2010. All consecutive patients aged 16 years or older with MTI were eligible at discharge from EDs. They underwent standardized clinical and radiologic evaluations at 1 and 2 weeks, followed by standardized telephone interviews at 30 and 90 days. A pain trajectory model characterized groups of patients with different pain evolutions and ascertained specific risk factors in each group through multivariate analysis. In this cohort of 1,132 patients, 734 were eligible for study inclusion. The authors identified a pain trajectory that characterized 18.2% of the study population experiencing clinically significant pain (>3 of 10) at 90 days after a MTI. Multivariate modeling found two or more rib fractures, smoking, and initial oxygen saturation below 95% to be predictors of this group of patients. To the authors' knowledge, this is the first prospective study of trajectory modeling to detect risk factors associated with significant pain at 90 days after MTI. These factors may help in planning specific treatment strategies and should be validated in another prospective cohort. © 2013 by the Society for Academic Emergency Medicine.

Design, development and deployment of a Diabetes Research Registry to facilitate recruitment in clinical research.

PubMed

Tan, Meng H; Bernstein, Steven J; Gendler, Stephen; Hanauer, David; Herman, William H

2016-03-01

A major challenge in conducting clinical trials/studies is the timely recruitment of eligible subjects. Our aim is to develop a Diabetes Research Registry (DRR) to facilitate recruitment by matching potential subjects interested in research with approved clinical studies using study entry criteria abstracted from their electronic health records (EHR). A committee with expertise in diabetes, quality improvement, information technology, and informatics designed and developed the DRR. Using a hybrid approach, we identified and consented patients interested in research, abstracted their EHRs to assess common eligibility criteria, and contacted them about their interest in participating in specific studies. Investigators submit their requests with study entry criteria to the DRR which then provides a list of potential subjects who may be directly contacted for their study. The DRR meets all local, regional and federal regulatory requirements. After 5 years, the DRR has over 5000 registrants. About 30% have type 1 diabetes and 70% have type 2 diabetes. There are almost equal proportions of men and women. During this period, 31 unique clinical studies from 19 unique investigators requested lists of potential subjects for their studies. Eleven grant applications from 10 unique investigators used aggregated counts of potentially eligible subjects in their applications. The DRR matches potential subjects interested in research with approved clinical studies using study entry criteria abstracted from their EHR. By providing large lists of potentially eligible study subjects quickly, the DRR facilitated recruitment in 31 clinical studies. Copyright © 2016 Elsevier Inc. All rights reserved.

Differences in Functional Outcomes for Adult Patients with Prosthodontically-Treated and -Untreated Shortened Dental Arches: A Systematic Review

PubMed Central

Khan, Saadika; Musekiwa, Alfred; Chikte, Usuf M. E.; Omar, Ridwaan

2014-01-01

This review examined differences in functional outcomes and patient satisfaction when shortened dental arches are left untreated compared to their restoration to complete arch lengths with different prosthodontic interventions. Methods A protocol was developed according to the criteria for a systematic review. All relevant databases were searched to identify appropriate clinical trials regardless of language or publication status. Predetermined eligibility criteria were applied, trial quality assessed and data extracted for each study. Relevant outcomes assessed were: functioning ability, patient satisfaction and harmful effects on oral structures. Results Searches yielded 101 articles: 81 from electronic databases and 20 from reference lists of retrieved articles (PEARLing searches). Sixty-nine citations were assessed for eligibility after removing 32 duplicate records. After reading titles and abstracts, a total of 41 records were excluded and the full-texts of the remaining 28 records were read. Only 21 records were included for the SR because 7 records were excluded after reading the full-text reports. These 21 records report the outcomes of four randomized controlled trials (RCTs) and one non-randomized clinical trial (CT) which were pre-specified and used for this review. No on-going studies were found and no eligible studies were excluded for failure to report the reviewer’s pre-specified outcomes. Outcomes were reported in the retrieved 21 articles. A narrative explanation of the pre-specified outcomes is reported for the 3 comparison groups (which were based on the different interventions used for the individual clinical trials). The shortened dental arch as a treatment option is encouraging in terms of functioning, patient satisfaction and cost-effectiveness. By using only high quality studies it was expected that the results would be more reliable when making conclusions and recommendations, but some of the included studies had to be downgraded due to methodological errors. PMID:24992473

Electrocardiographic findings in Emergency Department patients with pulmonary embolism.

PubMed

Richman, Peter B; Loutfi, Hassan; Lester, Steven J; Cambell, Patricia; Matthews, Jessica; Friese, Jeremy; Wood, Joseph; Kasper, David; Chen, Frederick; Mandell, Mark

2004-08-01

To assess the pre-study, null hypothesis that there is no difference in the electrocardiogram (EKG) findings for Emergency Department (ED) patients who rule in vs. rule out for suspected pulmonary embolism, a retrospective review of a cohort of patients with pulmonary embolism and their controls was conducted in an academic, suburban ED. Patients who were evaluated in the ED during a one-year study period for symptoms suggestive of pulmonary embolism were eligible for inclusion. All patients with pulmonary embolism and sex- and age-matched controls comprised the final study groups. Two board-certified cardiologists reviewed each patient's EKG. There were 350 eligible patients identified; 49 patients with pulmonary embolism and 49 controls were entered into the study. The most common rhythm observed in both groups was normal sinus rhythm (67.3% cases vs. 68.6 % controls; p = 1.0). Abnormalities believed to be associated with pulmonary embolism occurred with similar frequency in both case and control groups (sinus tachycardia [18.8 % vs. 11.8%, respectively; p = 0.40]), incomplete right bundle branch block (4.2% vs. 0.0%, respectively; p = 0.24), complete right bundle branch block (4.2% vs. 6.0, respectively; p = 1.0), S1Q3T3 pattern (2.1 vs. 0.0, respectively; p = 0.49), S1Q3 pattern (0.0 vs. 0.0), and extreme right axis (0.0 vs. 0.0). New EKG changes were identified more frequently for patients with pulmonary embolism (33.3% vs. 12.5% controls; p = 0.03), but specific findings were rarely different between cases and controls. In our cohort of ED patients, we did not identify EKG features that are likely to help distinguish patients with pulmonary embolism from those who rule out for the disease.

Understanding the role of physician attire on patient perceptions: a systematic review of the literature— targeting attire to improve likelihood of rapport (TAILOR) investigators

PubMed Central

Petrilli, Christopher Michael; Mack, Megan; Petrilli, Jennifer Janowitz; Hickner, Andy; Saint, Sanjay; Chopra, Vineet

2015-01-01

Objectives Despite a growing body of literature, uncertainty regarding the influence of physician dress on patients’ perceptions exists. Therefore, we performed a systematic review to examine the influence of physician attire on patient perceptions including trust, satisfaction and confidence. Setting, participants, interventions and outcomes We searched MEDLINE, Embase, Biosis Previews and Conference Papers Index. Studies that: (1) involved participants ≥18 years of age; (2) evaluated physician attire; and (3) reported patient perceptions related to attire were included. Two authors determined study eligibility. Studies were categorised by country of origin, clinical discipline (eg, internal medicine, surgery), context (inpatient vs outpatient) and occurrence of a clinical encounter when soliciting opinions regarding attire. Studies were assessed using the Downs and Black Scale risk of bias scale. Owing to clinical and methodological heterogeneity, meta-analyses were not attempted. Results Of 1040 citations, 30 studies involving 11 533 patients met eligibility criteria. Included studies featured patients from 14 countries. General medicine, procedural (eg, general surgery and obstetrics), clinic, emergency departments and hospital settings were represented. Preferences or positive influence of physician attire on patient perceptions were reported in 21 of the 30 studies (70%). Formal attire and white coats with other attire not specified was preferred in 18 of 30 studies (60%). Preference for formal attire and white coats was more prevalent among older patients and studies conducted in Europe and Asia. Four of seven studies involving procedural specialties reported either no preference for attire or a preference for scrubs; four of five studies in intensive care and emergency settings also found no attire preference. Only 3 of 12 studies that surveyed patients after a clinical encounter concluded that attire influenced patient perceptions. Conclusions Although patients often prefer formal physician attire, perceptions of attire are influenced by age, locale, setting and context of care. Policy-based interventions that target such factors appear necessary. PMID:25600254

Patterns of colorectal cancer screening uptake in newly-eligible men and women

PubMed Central

Wernli, Karen J.; Hubbard, Rebecca A.; Johnson, Eric; Chubak, Jessica; Kamineni, Aruna; Green, Beverly B.; Rutter, Carolyn M.

2014-01-01

Background We describe patterns of colorectal cancer screening uptake in a U.S. insured population as individuals become newly-eligible for screening at age 50 and assess temporal trends and patient characteristics with screening uptake. Methods We identified a cohort of 81,223 men and women who were members of Group Health and turned 50 years old from 1996 – 2010. We ascertained receipt of colorectal cancer screening within five years. Time to screening was estimated by year of cohort entry using cumulative incidence curves and Cox proportional hazards models estimated patient characteristics associated with screening uptake. Results Stool-based screening tests were the most common, 72% of first screening tests. The proportion of individuals initiating colorectal cancer screening via colonoscopy increased from 8% in 1996–98 to 33% in 2008–10. Patient factors associated with increased colorectal cancer screening were: turning 50 more recently (2008–10) (p-trend<0.0001) or Asian race (HR=1.14, 95% CI 1.10–1.19). Patient factors associated with decreased screening were: being a woman (HR=0.70, 95% CI 0.68–0.72), Native American (HR=0.68, 95% CI 0.60–0.78) or Pacific Islander race (HR=0.82, 95% CI 0.72–0.95), and having prevalent diabetes (HR=0.78, 95% CI 0.75–0.82) and higher body mass index (p-trend<0.0001). Conclusions Patient characteristics associated with initiation of colorectal cancer screening in a newly-eligible population are similar to characteristics associated with overall screening participation in all age-eligible adults. Our results identify patient populations to target in outreach programs. Impact Disparities in receipt of colorectal cancer screening are evident from onset of an age-eligible cohort, identifying key groups for future interventions for screening. PMID:24793956

HIV/STD pattern and its associated risk factors among male STD clinic attendees in China: a foci for HIV intervention

PubMed Central

2011-01-01

Background Previous studies suggested a high prevalence of STDs including HIV among female sex workers and men who have sex with men in China, but little was known about the prevalence in male patients attending public STD clinics. The aim of this study was to investigate STD patterns and HIV prevalence among male STD clinic attendees in different areas in China and the associated risk factors. The feasibility of Provider-initiated HIV testing and counseling (PITC) was evaluated as well. Methods A cross-sectional study was conducted at 46 public STD clinics in 4 provinces in China. Between July 2009 and September 2009, a total of 3243 eligible subjects were invited to participate in an interview with a structured-questionnaire for collecting socio-demographic characteristics and sexual behavioral information. They also were asked to provide venous blood samples for serological determinations of HIV and syphilis infection, and first void urine specimens for detecting Chlamydia trachomatis and Neisseria gonorrhoeae infections, Results Out of the 3243 eligible patients, 2951(91%) men agreed to take part in the HIV and syphilis testing. The overall prevalence rate of HIV infection was 0.7% while the rates of syphilis, N. gonorrhoeae, C. trachomatis infections were 10.7%, 4.3% and 6.9%, respectively, with the highest syphilis and N. gonorrhoeae rates in Jiangsu Province. Patients from Guangxi province, homosexual/bisexual practices and intravenous drug use were significantly associated with HIV infection in multivariate logistic regression analyses. Provider-initiated HIV testing and counseling (PITC) was well accepted by attendees, with 91% of eligible attendees agreeing to undergo HIV testing and counseling. All HIV positive patients were properly managed accordingly. Conclusions A modest prevalence of HIV infection and substantial prevalence of other STD infections were found among male patients attending public STD clinics in China. The findings further support the introduction of HIV and syphilis PITC strategy into this important setting. PMID:22200257

HIV/STD pattern and its associated risk factors among male STD clinic attendees in China: a foci for HIV intervention.

PubMed

Wang, Qian-Qiu; Chen, Xiang-Sheng; Yin, Yue-Ping; Liang, Guo-Jun; Jiang, Ning; Dai, Ting; Huan, Xi-Ping; Yang, Bing; Liu, Qiao; Zhou, Yu-Jiao; Wang, Bao-Xi

2011-12-26

Previous studies suggested a high prevalence of STDs including HIV among female sex workers and men who have sex with men in China, but little was known about the prevalence in male patients attending public STD clinics. The aim of this study was to investigate STD patterns and HIV prevalence among male STD clinic attendees in different areas in China and the associated risk factors. The feasibility of Provider-initiated HIV testing and counseling (PITC) was evaluated as well. A cross-sectional study was conducted at 46 public STD clinics in 4 provinces in China. Between July 2009 and September 2009, a total of 3243 eligible subjects were invited to participate in an interview with a structured-questionnaire for collecting socio-demographic characteristics and sexual behavioral information. They also were asked to provide venous blood samples for serological determinations of HIV and syphilis infection, and first void urine specimens for detecting Chlamydia trachomatis and Neisseria gonorrhoeae infections, Out of the 3243 eligible patients, 2951(91%) men agreed to take part in the HIV and syphilis testing. The overall prevalence rate of HIV infection was 0.7% while the rates of syphilis, N. gonorrhoeae, C. trachomatis infections were 10.7%, 4.3% and 6.9%, respectively, with the highest syphilis and N. gonorrhoeae rates in Jiangsu Province. Patients from Guangxi province, homosexual/bisexual practices and intravenous drug use were significantly associated with HIV infection in multivariate logistic regression analyses. Provider-initiated HIV testing and counseling (PITC) was well accepted by attendees, with 91% of eligible attendees agreeing to undergo HIV testing and counseling. All HIV positive patients were properly managed accordingly. A modest prevalence of HIV infection and substantial prevalence of other STD infections were found among male patients attending public STD clinics in China. The findings further support the introduction of HIV and syphilis PITC strategy into this important setting.

Exploring the performance of the National Early Warning Score (NEWS) in a European emergency department.

PubMed

Alam, N; Vegting, I L; Houben, E; van Berkel, B; Vaughan, L; Kramer, M H H; Nanayakkara, P W B

2015-05-01

Several triage systems have been developed for use in the emergency department (ED), however they are not designed to detect deterioration in patients. Deteriorating patients may be at risk of going undetected during their ED stay and are therefore vulnerable to develop serious adverse events (SAEs). The national early warning score (NEWS) has a good ability to discriminate ward patients at risk of SAEs. The utility of NEWS had not yet been studied in an ED. To explore the performance of the NEWS in an ED with regard to predicting adverse outcomes. A prospective observational study. Patients Eligible patients were those presenting to the ED during the 6 week study period with an Emergency Severity Index (ESI) of 2 and 3 not triaged to the resuscitation room. NEWS was documented at three time points: on arrival (T0), hour after arrival (T1) and at transfer to the general ward/ICU (T2). The outcomes of interest were: hospital admission, ICU admission, length of stay and 30 day mortality. A total of 300 patients were assessed for eligibility. Complete data was able to be collected for 274 patients on arrival at the ED. NEWS was significantly correlated with patient outcomes, including 30 day mortality, hospital admission, and length of stay at all-time points. The NEWS measured at different time points was a good predictor of patient outcomes and can be of additional value in the ED to longitudinally monitor patients throughout their stay in the ED and in the hospital. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

A phase II study of apatinib in patients with recurrent epithelial ovarian cancer.

PubMed

Miao, Mingming; Deng, Guanming; Luo, Sujuan; Zhou, Jiajia; Chen, Le; Yang, Jun; He, Jie; Li, Junjun; Yao, Jing; Tan, Shanmei; Tang, Jie

2018-02-01

Antiangiogenic treatments have been implicated to play a major role in epithelial ovarian cancer (EOC). Apatinib, a novel oral antiangiogenic agent targeting vascular endothelial growth factor receptor (VEGFR2), is currently being studied in different tumor types and is already used in gastric adenocarcinoma. This study was performed to assess the efficacy and safety of apatinib in patients with recurrent, pretreated EOC. Patients with recurrent, platinum-resistant, pre-treated EOC who failed available standard chemotherapy were enrolled. Apatinib was administered as 500mg daily. Primary objective is the overall response rate (ORR) according to MASS criteria. Secondary objectives are progression free survival (PFS), overall survival (OS), disease control rate (DCR), safety and tolerability. The treatment duration is until disease progression or intolerability of apatinib. 29 eligible patients were enrolled in this multicenter, open-label, single arm study and received apatinib for a median of 36.8weeks (range 13-64.8weeks). Median follow-up time was 12months. 28 patients were eligible for efficacy analysis. ORR is 41.4% (95% confidence interval (CI), 23.3%-59.4%). DCR is 68.9% (95% CI, 52.1%-85.8%). Median PFS is 5.1months (95% CI, 3.8m-6.5m). Median OS is 14.5months (95% CI, 12.4m-16.4m). The most common treatment-related adverse events (AEs) were hand-foot syndrome (51.7%), hypertension (34.6%), nausea and vomiting (31.0%). 3 patients had no significant toxicity. 9 patients experienced grade 3 treatment-related AEs. Apatinib 500mg daily p.o. is a feasible treatment in patients with recurrent, platinum-resistant, pretreated EOC. Multi-center prospective studies enrolling more patients are needed. Copyright © 2017 Elsevier Inc. All rights reserved.

Auricular Acupressure Helps Alleviate Xerostomia in Maintenance Hemodialysis Patients: A Pilot Study.

PubMed

Yang, Guowen; Lin, Shaoqin; Wu, Yuchi; Zhang, Shangpeng; Wu, Xiuqing; Liu, Xusheng; Zou, Chuan; Lin, Qizhan

2017-04-01

Xerostomia is one of the most common complaints in maintenance hemodialysis (MHD) patients. This problem contributes to excess fluid intake and results in poor survival outcome. Based on Traditional Chinese Medicine (TCM) theory and literature studies, the authors have been practicing auricular acupressure therapy (AAT) to help patients with xerostomia. This pilot study was conducted to demonstrate the potential of AAT for xerostomia in MHD patients. Eligible subjects who agreed to participate in this study were recruited and provided with AAT for 4 weeks. The Summated Xerostomia Inventory (SXI), as well as measurement of inter-dialytic weight gain (IDWG), daily inter-dialytic weight gain (daily IDWG), percentage of inter-dialytic weight gain (IDWG%), blood pressure, and biochemical parameters, were completed at baseline and after a 4-week intervention. A total of 26 eligible participants were recruited. Of them, 10 men and 16 women (M age  = 52.92 ± 11.80 years; dialysis vintage 81.86 ± 46.05 months) completed the study. After the 4-week AAT intervention, the SXI scores were significantly decreased compared with baseline (from 10.08 ± 2.26 to 9.04 ± 2.14; p < 0.05). However, the IDWG, daily IDWG, IDWG%, blood pressure, and biochemical parameters did not change significantly after the intervention. This study provides preliminary evidence that AAT may be effective in reducing xerostomia intensity for MHD patients.

Statin Eligibility and Outpatient Care Prior to ST-Segment Elevation Myocardial Infarction.

PubMed

Miedema, Michael D; Garberich, Ross F; Schnaidt, Lucas J; Peterson, Erin; Strauss, Craig; Sharkey, Scott; Knickelbine, Thomas; Newell, Marc C; Henry, Timothy D

2017-04-12

The impact of the 2013 American College of Cardiology/American Heart Association cholesterol guidelines on statin eligibility in individuals otherwise destined to experience cardiovascular disease (CVD) events is unclear. We analyzed a prospective cohort of consecutive ST-segment elevation myocardial infarction (STEMI) patients from a regional STEMI system with data on patient demographics, low-density lipoprotein cholesterol levels, CVD risk factors, medication use, and outpatient visits over the 2 years prior to STEMI. We determined pre-STEMI eligibility according to American College of Cardiology/American Heart Association guidelines and the prior Third Report of the Adult Treatment Panel guidelines. Our sample included 1062 patients with a mean age of 63.7 (13.0) years (72.5% male), and 761 (71.7%) did not have known CVD prior to STEMI. Only 62.5% and 19.3% of individuals with and without prior CVD were taking a statin before STEMI, respectively. In individuals not taking a statin, median (interquartile range) low-density lipoprotein cholesterol levels in those with and without known CVD were low (108 [83, 138]  mg/dL and 110 [87, 133] mg/dL). For individuals not taking a statin, only 38.7% were statin eligible by ATP III guidelines. Conversely, 79.0% would have been statin eligible according to American College of Cardiology/American Heart Association guidelines. Less than half of individuals with (49.2%) and without (41.1%) prior CVD had seen a primary care provider during the 2 years prior to STEMI. In a large cohort of STEMI patients, application of American College of Cardiology/American Heart Association guidelines more than doubled pre-STEMI statin eligibility compared with Third Report of the Adult Treatment Panel guidelines. However, access to and utilization of health care, a necessity for guideline implementation, was suboptimal prior to STEMI. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

The Ronnie Gardiner Rhythm and Music Method - a feasibility study in Parkinson's disease.

PubMed

Pohl, Petra; Dizdar, Nil; Hallert, Eva

2013-01-01

To assess the feasibility of the novel intervention, Ronnie Gardiner Rhythm and Music (RGRM™) Method compared to a control group for patients with Parkinson's disease (PD). Eighteen patients, mean age 68, participating in a disability study within a neurological rehabilitation centre, were randomly allocated to intervention group (n = 12) or control group (n = 6). Feasibility was assessed by comparing effects of the intervention on clinical outcome measures (primary outcome: mobility as assessed by two-dimensional motion analysis, secondary outcomes: mobility, cognition, quality of life, adherence, adverse events and eligibility). Univariable analyses showed no significant differences between groups following intervention. However, analyses suggested that patients in the intervention group improved more on mobility (p = 0.006), cognition and quality of life than patients in the control group. There were no adverse events and a high level of adherence to therapy was observed. In this disability study, the use of the RGRM™ Method showed promising results in the intervention group and the adherence level was high. Our results suggest that most assessments chosen are eligible to use in a larger randomized controlled study for patients with PD. The RGRM™ Method appeared to be a useful and safe method that showed promising results in both motor and cognitive functions as well as quality of life in patients with moderate PD. The RGRM™ Method can be used by physiotherapists, occupational, speech and music therapists in neurological rehabilitation. Most measurements were feasible except for Timed-Up-and-Go.

Systematic Review and Meta-Analysis: Is Pre-Injury Antiplatelet Therapy Associated with Traumatic Intracranial Hemorrhage?

PubMed

van den Brand, Crispijn L; Tolido, Tanya; Rambach, Anna H; Hunink, Myriam G M; Patka, Peter; Jellema, Korné

2017-01-01

The objective of this systematic review and meta-analysis is to evaluate whether the pre-injury use of antiplatelet therapy (APT) is associated with increased risk of traumatic intracranial hemorrhage (tICH) on CT scan. PubMed, Medline, Embase, Cochrane Central, reference lists, and national guidelines on traumatic brain injury were used as data sources. Eligible studies were cohort studies and case-control studies that assessed the relationship between APT and tICH. Studies without control group were not included. The primary outcome of interest was tICH on CT. Two reviewers independently selected studies, assessed methodological quality, and extracted outcome data. This search resulted in 10 eligible studies with 20,247 patients with head injury that were included in the meta-analysis. The use of APT in patients with head injury was associated with significant increased risk of tICH compared with control (odds ratio [OR] 1.87, 95% confidence interval [CI]1.27-2.74). There was significant heterogeneity in the studies (I 2 84%), although almost all showed an association between APT use and tICH. This association could not be established for patients receiving aspirin monotherapy. When considering only patients with mild traumatic brain injury (mTBI), the OR is 2.72 (95% CI 1.92-3.85). The results were robust to sensitivity analysis on study quality. In summary, APT in patients with head injury is associated with increased risk of tICH; this association is most relevant in patients with mTBI. Whether this association is the result of a causal relationship and whether this relationship also exists for patients receiving aspirin monotherapy cannot be established with the current review and meta-analysis.

A phase I study of WR-2721 in combination with total body irradiation (TBI) in patients with refractory lymphoid malignancies

DOE Office of Scientific and Technical Information (OSTI.GOV)

Coia, L.; Krigel, R.; Hanks, G.

This Phase I study was designed to establish the maximum tolerated dose (MTD) of WR-2721 when given twice weekly with total body irradiation (TBI) in the treatment of patients with advanced refractory lymphoid malignancies and to define the toxicities of this combination and schedule. Patients eligible for this study had advanced recurrent indolent non-Hodgkin's lymphoma (NHL) or chronic lymphocytic leukemia (CLL). Patients had symptomatic or progressive disease, a performance status of 0, 1, or 2, and adequate bone marrow, hepatic, and renal function. Only patients failing one or two regimens of prior chemotherapy were eligible. Patients who had received priormore » extended field irradiation were ineligible. Patients received TBI twice weekly (Tuesday and Friday) to a total of 10 doses at 15 cGy/fx. WR-2721 was given intravenously over 15 min beginning 30 min before irradiation. The escalation of WR-2721 was Level 1: 740 mg/m2 and Level 2: 910 mg/m2. The MTD of WR-2721 was that dose which produced predictable and reversible toxicity and would not interfere with patient well-being. Seven patients were entered onto the study, three at 740 mg/m2 and four at 910 mg/m2. Five patients had CLL and two patients small lymphocytic NHL. No patient had hypotension or nausea requiring reduction in dose level or even interruption of infusion of WR-2721. At 740 mg/m2 no grade 3 or 4 toxicities related to WR-2721 were observed, but two patients could not complete treatment because of TBI-induced prolonged thrombocytopenia following treatments 5 and 8. One patient completed all 10 treatments. At 910 mg/m2 of WR-2721, two patients requested removal from study because of malaise, one after 5 cycles and one after 7 cycles. One patient completed all 10 treatments.« less

Medicaid/CHIP Program; Medicaid Program and Children's Health Insurance Program (CHIP); Changes to the Medicaid Eligibility Quality Control and Payment Error Rate Measurement Programs in Response to the Affordable Care Act. Final rule.

PubMed

2017-07-05

This final rule updates the Medicaid Eligibility Quality Control (MEQC) and Payment Error Rate Measurement (PERM) programs based on the changes to Medicaid and the Children's Health Insurance Program (CHIP) eligibility under the Patient Protection and Affordable Care Act. This rule also implements various other improvements to the PERM program.

The Comparative Efficacy of the Masquelet versus Titanium Mesh Cage Reconstruction Techniques for the Treatment of Large Long Bone Deficiencies

DTIC Science & Technology

2016-10-01

include 9 MT, 7 TMCT. Within the last 12-month study period, 8 patients were enrolled, 2 completed the study, 1 was withdrawn, and 11 are actively ...TMCT) are being actively followed, and their study courses are uneventful. There are 3 additional potentially eligible study patients identified...Uneventfully Subjects Actively Participating Subjects Removed from Trial Continuation Masquelet 9 2 6 1 Cage 7 0 5 2 Total: 16

Health literacy assessment and patient satisfaction in surgical practice.

PubMed

Komenaka, Ian K; Nodora, Jesse N; Machado, Lorenzo; Hsu, Chiu-Hsieh; Klemens, Anne E; Martinez, Maria Elena; Bouton, Marcia E; Wilhelmson, Krista L; Weiss, Barry D

2014-03-01

Individuals with limited health literacy have barriers to patient-physician communication. Problems in communication are known to contribute to malpractice litigation. Concern exists, however, about the feasibility and patient acceptance of a health literacy assessment. This study was performed to determine the feasibility of health literacy assessment in surgical practice and its effect on patient satisfaction. Every patient seen in a Breast Surgery Clinic during a 2-year period was asked to undergo a health literacy assessment with the Newest Vital Sign (NVS) as part of the routine history and physical examination. During the year before routine NVS assessments and during the 2-year study period, all patients were asked to rate their "overall satisfaction with clinic visit" on a 5-point scale. A total of 2,026 of 2,097 patients (96.6%) seen during the study were eligible for the health literacy assessment. Of those, no patients refused assessment, and only one patient was missed. Therefore, 2,025 of 2,026 eligible patients (99.9%) underwent the assessment. The average time for NVS assessment was 2:02 minutes. Only 19% of patients had adequate health literacy. Patient satisfaction ratings were slightly greater during the first year of the health literacy assessment (3.8 vs 3.7, P = .049) compared with the year prior to health literacy assessment and greater during the second year of health literacy assessment (4.1 vs 3.7, P < .0001). Routine health literacy assessment is feasible in surgical practice and results in no decrease in patient satisfaction. In fact, satisfaction was greater during the years when health literacy assessments were performed. Copyright © 2014 Mosby, Inc. All rights reserved.

Patient-mediated knowledge translation (PKT) interventions for clinical encounters: a systematic review.

PubMed

Gagliardi, Anna R; Légaré, France; Brouwers, Melissa C; Webster, Fiona; Badley, Elizabeth; Straus, Sharon

2016-02-29

Patient-mediated knowledge translation (PKT) interventions engage patients in their own health care. Insight on which PKT interventions are effective is lacking. We sought to describe the type and impact of PKT interventions. We performed a systematic review of PKT interventions, defined as strategies that inform, educate and engage patients in their own health care. We searched MEDLINE, EMBASE and the Cochrane Library from 2005 to 2014 for English language studies that evaluated PKT interventions delivered immediately before, during or upon conclusion of clinical encounters to individual patients with arthritis or cancer. Data were extracted on study characteristics, PKT intervention (theory, content, delivery, duration, personnel, timing) and outcomes. Interventions were characterized by type of patient engagement (inform, activate, collaborate). We performed content analysis and reported summary statistics. Of 694 retrieved studies, 16 were deemed eligible (5 arthritis, 11 cancer; 12 RCTs, 4 cohort studies; 7 low, 3 uncertain, 6 high risk of bias). PKT interventions included print material in 10 studies (brochures, booklets, variety of print material, list of websites), electronic material in 10 studies (video, computer program, website) and counselling in 2 studies. They were offered before, during and after consultation in 4, 1 and 4 studies, respectively; as single or multifaceted interventions in 10 and 6 studies, respectively; and by clinicians, health educators, researchers or volunteers in 4, 3, 5 and 1 study, respectively. Most interventions informed or activated patients. All studies achieved positive impact in one or more measures of patient knowledge, decision-making, communication and behaviour. This was true regardless of condition, PKT intervention, timing, personnel, type of engagement or delivery (single or multifaceted). No studies assessed patient harms, or interventions for providers to support PKT intervention delivery. Two studies evaluated the impact on providers of PKT interventions aimed at patients. Single interventions involving print material achieved beneficial outcomes as did more complex interventions. Few studies were eligible, and no studies evaluated patient harms, or provider outcomes. Further research is warranted to evaluate these PKT interventions in more patients, or patients with different conditions; different types of PKT interventions for patients and for providers; and potential harms associated with interventions.

Access assured: a pilot program to finance primary care for uninsured patients using a monthly enrollment fee.

PubMed

Saultz, John W; Brown, David; Stenberg, Stephen; Rdesinski, Rebecca E; Tillotson, Carrie J; Eigner, Danielle; Devoe, Jennifer

2010-01-01

Access Assured is an experimental program being used by 2 academic family medicine practices to deliver primary care to an uninsured patient population using a monthly retainer payment system in addition to a sliding fee schedule for office visits. This prospective cohort study was designed to determine whether patients would join such a program, to describe the population of people who did so, and to assess the program's financial viability. We used data abstracted from our electronic medical record system to describe the demographic characteristics and care utilization patterns of those patients enrolling during the first year of the study, between February 1, 2008, and January 31, 2009. We also compared 2 subpopulations of enrollees defined by their eligibility for office fee discounts based on income. A total of 600 Access Assured members made 1943 office visits during the study period, receiving a total of 4538.22 relative value units of service. Based on the membership fee, office visit fee collections, and remaining accounts receivable, this resulted in an expected reimbursement rate of $42.88 per relative value units. Three hundred one of the 600 (50.2%) patients had incomes above 400% of the federal poverty level (FPL) at the time of each of their office visits and were therefore not eligible for any visit fee discount. Another 156 patients (26.0%) were eligible for a 100% discount of all visit fees based on their income below 200% of the FPL. Using a multivariable Poisson regression analysis of these 2 groups, we determined that age was a significant determinant of return visit rate, with a 0.7% increase in return visit rate for each additional year of age (P = .006). Women had a 26% higher return visit rate than men (P = .001). After accounting for age, sex, and clinic site, fee discount level based on income was not a significant independent determinant of return visit rate (P = .118). A retainer-based program to enroll uninsured patients being used in 2 academic family medicine clinics attracted 600 patients during its first year. The program was financially viable and resulted in an expansion of our service to uninsured patients. More than half of the patients had incomes above 400% of the FPL, suggesting that the population of uninsured Oregonians may be economically more diverse than suspected.

Implicit bias in healthcare professionals: a systematic review.

PubMed

FitzGerald, Chloë; Hurst, Samia

2017-03-01

Implicit biases involve associations outside conscious awareness that lead to a negative evaluation of a person on the basis of irrelevant characteristics such as race or gender. This review examines the evidence that healthcare professionals display implicit biases towards patients. PubMed, PsychINFO, PsychARTICLE and CINAHL were searched for peer-reviewed articles published between 1st March 2003 and 31st March 2013. Two reviewers assessed the eligibility of the identified papers based on precise content and quality criteria. The references of eligible papers were examined to identify further eligible studies. Forty two articles were identified as eligible. Seventeen used an implicit measure (Implicit Association Test in fifteen and subliminal priming in two), to test the biases of healthcare professionals. Twenty five articles employed a between-subjects design, using vignettes to examine the influence of patient characteristics on healthcare professionals' attitudes, diagnoses, and treatment decisions. The second method was included although it does not isolate implicit attitudes because it is recognised by psychologists who specialise in implicit cognition as a way of detecting the possible presence of implicit bias. Twenty seven studies examined racial/ethnic biases; ten other biases were investigated, including gender, age and weight. Thirty five articles found evidence of implicit bias in healthcare professionals; all the studies that investigated correlations found a significant positive relationship between level of implicit bias and lower quality of care. The evidence indicates that healthcare professionals exhibit the same levels of implicit bias as the wider population. The interactions between multiple patient characteristics and between healthcare professional and patient characteristics reveal the complexity of the phenomenon of implicit bias and its influence on clinician-patient interaction. The most convincing studies from our review are those that combine the IAT and a method measuring the quality of treatment in the actual world. Correlational evidence indicates that biases are likely to influence diagnosis and treatment decisions and levels of care in some circumstances and need to be further investigated. Our review also indicates that there may sometimes be a gap between the norm of impartiality and the extent to which it is embraced by healthcare professionals for some of the tested characteristics. Our findings highlight the need for the healthcare profession to address the role of implicit biases in disparities in healthcare. More research in actual care settings and a greater homogeneity in methods employed to test implicit biases in healthcare is needed.

Live Donor Liver Transplantation Without Blood Products

PubMed Central

Jabbour, Nicolas; Gagandeep, Singh; Mateo, Rodrigo; Sher, Linda; Strum, Earl; Donovan, John; Kahn, Jeffrey; Peyre, Christian G.; Henderson, Randy; Fong, Tse-Ling; Selby, Rick; Genyk, Yuri

2004-01-01

Objective: Developing strategies for transfusion-free live donor liver transplantation in Jehovah's Witness patients. Summary Background Data: Liver transplantation is the standard of care for patients with end-stage liver disease. A disproportionate increase in transplant candidates and an allocation policy restructuring, favoring patients with advanced disease, have led to longer waiting time and increased medical acuity for transplant recipients. Consequently, Jehovah's Witness patients, who refuse blood product transfusion, are usually excluded from liver transplantation. We combined blood augmentation and conservation practices with live donor liver transplantation (LDLT) to accomplish successful LDLT in Jehovah's Witness patients without blood products. Our algorithm provides broad possibilities for blood conservation for all surgical patients. Methods: From September 1998 until June 2001, 38 LDLTs were performed at Keck USC School of Medicine: 8 in Jehovah's Witness patients (transfusion-free group) and 30 in non-Jehovah's Witness patients (transfusion-eligible group). All transfusion-free patients underwent preoperative blood augmentation with erythropoietin, intraoperative cell salvage, and acute normovolemic hemodilution. These techniques were used in only 7%, 80%, and 10%, respectively, in transfusion-eligible patients. Perioperative clinical data and outcomes were retrospectively reviewed. Data from both groups were statistically analyzed. Results: Preoperative liver disease severity was similar in both groups; however, transfusion-free patients had significantly higher hematocrit levels following erythropoietin augmentation. Operative time, blood loss, and postoperative hematocrits were similar in both groups. No blood products were used in transfusion-free patients while 80% of transfusion-eligible patients received a median of 4.5+/− 3.5 units of packed red cell. ICU and total hospital stay were similar in both groups. The survival rate was 100% in transfusion-free patients and 90% in transfusion-eligible patients. Conclusions: Timely LDLT can be done successfully without blood product transfusion in selected patients. Preoperative preparation, intraoperative cell salvage, and acute normovolemic hemodilution are essential. These techniques may be widely applied to all patients for several surgical procedures. Chronic blood product shortages, as well as the known and unknown risk of blood products, should serve as the driving force for development of transfusion-free technology. PMID:15273561

Racial Disparities in Hepatitis C Treatment Eligibility.

PubMed

Sims, Omar; Pollio, David; Hong, Barry; North, Carol

2017-01-01

Hepatitis C (HCV) is more prevalent in African Americans than in any other racial group in the United States. However, African Americans are more likely to be deemed ineligible for HCV treatment than non-African Americans. There has been limited research into the origins of racial disparities in HCV treatment eligibility. The purpose of this study was to compare medical and non-medical characteristics commonly assessed in clinical practice that could potentially contribute to HCV treatment ineligibility disparities between African American and non-African American patients. Patients with confirmed HCV RNA considering treatment (n = 309) were recruited from university-affiliated and VA liver and infectious disease clinics. African Americans and non-African Americans did not differ in prevalence of lifetime and current psychiatric disorders and risky behaviors, and HCV knowledge. HCV clinical characteristics were similar between both groups in terms of HCV exposure history, number of months aware of HCV diagnosis, stage of fibrosis, and HCV virologic levels. African Americans did have higher proportions of diabetes, renal disease, and bleeding ulcer. No clinical evidence was found to indicate that African Americans should be more often deemed ineligible for HCV treatment than other racial groups. Diabetes and renal disease do not fully explain the HCV treatment ineligibility racial disparity, because HCV patients with these conditions are priority patients for HCV treatment because of their greater risk for cirrhosis, steatosis, and hepatocellular carcinoma. The findings suggest that an underlying contributor to the HCV treatment eligibility disparity disfavoring African Americans could be racial discrimination.

Cardiovascular Risk and Statin Eligibility of Young Adults After an MI

PubMed Central

Singh, Avinainder; Collins, Bradley L.; Gupta, Ankur; Fatima, Amber; Qamar, Arman; Biery, David; Baez, Julio; Cawley, Mary; Klein, Josh; Hainer, Jon; Plutzky, Jorge; Cannon, Christopher P.; Nasir, Khurram; Di Carli, Marcelo F.; Bhatt, Deepak L.; Blankstein, Ron

2018-01-01

BACKGROUND Despite significant progress in primary prevention, the rate of MI has not declined in young adults. OBJECTIVES The purpose of this study was to evaluate statin eligibility based on the 2013 American College of Cardiology/American Heart Association guidelines for treatment of blood cholesterol and 2016 U.S. Preventive Services Task Force recommendations for statin use in primary prevention in a cohort of adults who experienced a first-time myocardial infarction (MI) at a young age. METHODS The YOUNG-MI registry is a retrospective cohort from 2 large academic centers, which includes patients who experienced an MI at age ≤50 years. Diagnosis of type 1 MI was adjudicated by study physicians. Pooled cohort risk equations were used to estimate atherosclerotic cardiovascular disease risk score based on data available prior to MI or at the time of presentation. RESULTS Of 1,685 patients meeting inclusion criteria, 210 (12.5%) were on statin therapy prior to MI and were excluded. Among the remaining 1,475 individuals, the median age was 45 years, there were 294 (20%) women, and 846 (57%) had ST-segment elevation MI. At least 1 cardiovascular risk factor was present in 1,225 (83%) patients. The median 10-year atherosclerotic cardiovascular disease risk score of the cohort was 4.8% (interquartile range: 2.8% to 8.0%). Only 724 (49%) and 430 (29%) would have met criteria for statin eligibility per the 2013 American College of Cardiology/American Heart Association guidelines and 2016 U.S. Preventive Services Task Force recommendations, respectively. This finding was even more pronounced in women, in whom 184 (63%) were not eligible for statins by either guideline, compared with 549 (46%) men (p < 0.001). CONCLUSIONS The vast majority of adults who present with an MI at a young age would not have met current guideline-based treatment thresholds for statin therapy prior to their MI. These findings highlight the need for better risk assessment tools among young adults. PMID:29141201

Sex and Race/Ethnicity Differences in Implantable Cardioverter-Defibrillator Counseling and Use Among Patients Hospitalized With Heart Failure: Findings from the Get With The Guidelines-Heart Failure Program.

PubMed

Hess, Paul L; Hernandez, Adrian F; Bhatt, Deepak L; Hellkamp, Anne S; Yancy, Clyde W; Schwamm, Lee H; Peterson, Eric D; Schulte, Phillip J; Fonarow, Gregg C; Al-Khatib, Sana M

2016-08-16

Previous studies have found that women and black patients eligible for a primary prevention implantable cardioverter-defibrillator (ICD) are less likely than men or white patients to receive one. We performed an observational analysis of the Get With The Guidelines-Heart Failure Program from January 1, 2011, to March 21, 2014. Patients admitted with heart failure and an ejection fraction ≤35% without an ICD were included. Rates of ICD counseling among eligible patients and ICD receipt among counseled patients were examined by sex and race/ethnicity. Among 21 059 patients from 236 sites, 4755 (22.6%) received predischarge ICD counseling. Women were counseled less frequently than men (19.3% versus 24.6%, P<0.001, adjusted odds ratio [OR], 0.84; 95% confidence interval [CI], 0.78-0.91). Racial and ethnic minorities were less likely to receive counseling than white patients (black 22.6%, Hispanic 18.6%, other race/ethnic group 14.4% versus white 24.3%, P<0.001 for each): adjusted OR versus white, 0.69; 95% CI, 0.63 to 0.76 for black patients; adjusted OR, 0.62; 95% CI, 0.55 to 0.70 for Hispanic patients; adjusted OR, 0.53; 95% CI, 0.43 to 0.65 for other patients. Among the 4755 counseled patients, 2977 (62.6%) received an ICD or had one planned for placement after hospital stay. Among those counseled, women and men were similarly likely to receive an ICD (adjusted OR, 1.13; 95% CI, 0.99-1.29). However, black (adjusted OR, 0.70; 95% CI, 0.56-0.88) and Hispanic patients (adjusted OR, 0.68; 95% CI, 0.46-1.01) were less likely to receive an ICD. Up to 4 of 5 hospitalized patients with heart failure eligible for ICD counseling did not receive it, particularly women and minority patients. Among counseled patients, ICD use differences by race and ethnicity persisted. © 2016 American Heart Association, Inc.

Review of information technology for surgical patient care.

PubMed

Robinson, Jamie R; Huth, Hannah; Jackson, Gretchen P

2016-06-01

Electronic health records (EHRs), computerized provider order entry (CPOE), and patient portals have experienced increased adoption by health care systems. The objective of this study was to review evidence regarding the impact of such health information technologies (HIT) on surgical practice. A search of Medline, EMBASE, CINAHL, and the Cochrane Library was performed to identify data-driven, nonsurvey studies about the effects of HIT on surgical care. Domain experts were queried for relevant articles. Two authors independently reviewed abstracts for inclusion criteria and analyzed full text of eligible articles. A total of 2890 citations were identified. Of them, 32 observational studies and two randomized controlled trials met eligibility criteria. EHR or CPOE improved appropriate antibiotic administration for surgical procedures in 13 comparative observational studies. Five comparative observational studies indicated that electronically generated operative notes had increased accuracy, completeness, and availability in the medical record. The Internet as an information resource about surgical procedures was generally inadequate. Surgical patients and providers demonstrated rapid adoption of patient portals, with increasing proportions of online versus inperson outpatient surgical encounters. The overall quality of evidence about the effects of HIT in surgical practice was low. Current data suggest an improvement in appropriate perioperative antibiotic administration and accuracy of operative reports from CPOE and EHR applications. Online consumer health educational resources and patient portals are popular among patients and families, but their impact has not been studied well in surgical populations. With increasing adoption of HIT, further research is needed to optimize the efficacy of such tools in surgical care. Copyright © 2016 Elsevier Inc. All rights reserved.

How do Australian patients rate their general practitioner? A descriptive study using the General Practice Assessment Questionnaire.

PubMed

Potiriadis, Maria; Chondros, Patty; Gilchrist, Gail; Hegarty, Kelsey; Blashki, Grant; Gunn, Jane M

2008-08-18

To report patient responses to the General Practice Assessment Questionnaire (GPAQ) as a measure of satisfaction with health care received from Australian general practitioners. A clustered cross-sectional study involving general practice patients from 30 randomly selected general practices in Victoria. Between January and December 2005, a screening survey, including a postal version of the GPAQ, was mailed to 17 780 eligible patients. Scores on the six GPAQ items. We analysed data from 7130 patients who completed the screening survey and fulfilled our eligibility criteria. Levels of patient satisfaction with general practice care were generally high: mean GPAQ scores ranged from 68.6 (95% CI, 66.1-71.0) for satisfaction with access to the practice to 84.0 (95% CI, 82.2-85.4) for satisfaction with communication. Intracluster correlations for the GPAQ items ranged from 0.016 for overall satisfaction with the practice to 0.163 for satisfaction with access to the practice. Compared with national benchmarks in the United Kingdom, the GPs and practices participating in our study were rated higher on all six GPAQ items. Multivariable mixed effects linear regression showed that patients who were older, rated their health more highly, visited their GP more frequently and saw the same GP each time tended to express greater satisfaction with their care. Generally patients reported high levels of satisfaction with GP care. Greater satisfaction with care was associated with older patients, good health, more frequent contact with the GP, and seeing the one GP consistently.

Effects of Screening for Psychological Distress on Patient Outcomes in Cancer: a Systematic Review

PubMed Central

Meijer, Anna; Roseman, Michelle; Delisle, Vanessa C.; Milette, Katherine; Levis, Brooke; Syamchandra, Achyuth; Stefanek, Michael E.; Stewart, Donna E.; de Jonge, Peter; Coyne, James C.; Thombs, Brett D.

2013-01-01

Objective Several practice guidelines recommend routine screening for psychological distress in cancer care. The objective was to evaluate the effect of screening cancer patients for psychological distress by assessing the (1) effectiveness of interventions to reduce distress among patients identified as distressed; and (2) effects of screening for distress on distress outcomes. Methods CINAHL, Cochrane, EMBASE, ISI, MEDLINE, PsycINFO, and SCOPUS databases were searched through April 6, 2011 with manual searches of 45 relevant journals, reference list review, citation tracking of included articles, and trial registry reviews through June 30, 2012. Articles in any language on cancer patients were included if they (1) compared treatment for patients with psychological distress to placebo or usual care in a randomized controlled trial (RCT); or (2) assessed the effect of screening on psychological distress in a RCT. Results There were 14 eligible RCTs for treatment of distress, and 1 RCT on the effects of screening on patient distress. Pharmacological, psychotherapy and collaborative care interventions generally reduced distress with small to moderate effects. One study investigated effects of screening for distress on psychological outcomes, and it found no improvement. Conclusion Treatment studies reported modest improvement in distress symptoms, but only a single eligible study was found on the effects of screening cancer patients for distress, and distress did not improve in screened patients versus those receiving usual care. Because of the lack of evidence of beneficial effects of screening cancer patients for distress, it is premature to recommend or mandate implementation of routine screening. PMID:23751231

Incidence of all-cause adult community-acquired pneumonia in primary care settings in France.

PubMed

Partouche, H; Lepoutre, A; Vaure, C Buffel du; Poisson, T; Toubiana, L; Gilberg, S

2018-04-12

To estimate the incidence of all-cause outpatient community-acquired pneumonia (CAP) in adults in France from a national prospective observational study of CAP management in general practice (CAPA). Patients aged over 18 years presenting with signs or symptoms indicative of CAP associated with recent onset of unilateral crackles on auscultation and/or a new opacity on chest X-ray were included in the CAPA study. An ancillary survey (AIMSIS) aiming at identifying family physicians' difficulties in including patients and at collecting their opinion on the use of an electronic case report form, determined the number of non-included eligible patients. A three-step analysis was then performed, including computation of the total number of eligible patients, adjustment for seasonality, and extrapolation to the French FP population using indirect standardization to adjust for differences in characteristics between CAPA FPs and French FPs. Between September 2011 and July 2012, 267 (63%) CAPA investigators included 886 CAP patients. Most patients presented with mild CAP. The rates of hospitalization and one-month case fatality were 7% and 0.3%, respectively. Data from 336 (79%) AIMSIS investigators identified 641 additional patients and estimated at 234,023 the number of CAP patients per year (incidence of 4.7 per 1000 persons per year). Using a pragmatic case definition of CAP patients, this study estimated an incidence of 4.7 per 1000 persons per year that is in the lower half of the range of estimated incidences reported in primary care settings in industrialized countries. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Risk factors for oral methotrexate failure in patients with inflammatory polyarthritis: results from a UK prospective cohort study.

PubMed

Bluett, James; Sergeant, Jamie C; MacGregor, Alex J; Chipping, Jacqueline R; Marshall, Tarnya; Symmons, Deborah P M; Verstappen, Suzanne M M

2018-03-20

Oral methotrexate (MTX) is the first-line therapy for patients with rheumatoid arthritis (RA). However, approximately one quarter of patients discontinue MTX within 12 months. MTX failure, defined as MTX cessation or the addition of another anti-rheumatic drug, is usually due adverse event(s) and/or inefficacy. The aims of this study were to evaluate the rate and predictors of oral MTX failure. Subjects were recruited from the Norfolk Arthritis Register (NOAR), a primary care-based inception cohort of patients with early inflammatory polyarthritis (IP). Subjects were eligible if they commenced MTX as their first DMARD and were recruited between 2000 and 2008. Patient-reported reasons for MTX failure were recorded and categorised as adverse event, inefficacy or other. The addition of a second DMARD during the study period was categorised as failure due to inefficacy. Cox proportional hazards regression models were used to assess potential predictors of MTX failure, accounting for competing risks. A total of 431 patients were eligible. The probability of patients remaining on MTX at 2 years was 82%. Competing risk analysis revealed that earlier MTX failure due to inefficacy was associated with rheumatoid factor (RF) positivity, younger age at symptom onset and higher baseline disease activity (DAS-28). MTX cessation due to an adverse event was less likely in the RF-positive cohort. RF-positive inflammatory polyarthritis patients who are younger with higher baseline disease activity have an increased risk of MTX failure due to inefficacy. Such patients may require combination therapy as a first-line treatment.

Sofosbuvir-based treatment regimens: real life results of 14 409 chronic HCV genotype 4 patients in Egypt.

PubMed

Elsharkawy, A; Fouad, R; El Akel, W; El Raziky, M; Hassany, M; Shiha, G; Said, M; Motawea, I; El Demerdash, T; Seif, S; Gaballah, A; El Shazly, Y; Makhlouf, M A M; Waked, I; Abdelaziz, A O; Yosry, A; El Serafy, M; Thursz, M; Doss, W; Esmat, G

2017-03-01

Chronic hepatitis C virus infection is one of the most important health problems in Egypt. The Ministry of Health's National Treatment Programme introduced sofosbuvir-based therapy in October 2014. To assess the clinical effectiveness and predictors of response to SOF-based treatment regimens, either dual therapy, with SOF/ribavirin (RBV) for 6 months or triple therapy with SOF/peg-IFN-alfa-2a/RBV for 3 months, in a cohort of patients treated in National Treatment Programme affiliated centres in Egypt. Between October 2014 and end of 2014, patients who were eligible for treatment were classified according to their eligibility for interferon therapy: Group 1 (interferon eligible) were treated with triple therapy for 12 weeks and Group 2 (interferon ineligible) were treated with dual therapy for 24 weeks. Difficult to treat patients included those with F3-F4 on Metavir score, Fib-4 >3.25, albumin ≤3.5, total Bilirubin >1.2 mg/dL, INR >1.2 and platelet count <150 000 mm 3 . Twelve weeks post-treatment data were available on 14 409 patients; 8742 in group 1 and 5667 in group 2. In group 1, the sustained virological response at week 12 (SVR12) was 94% and in group 2 the SVR12 was 78.7%. Multivariate logistic regression analysis in which treatment failure is the dependent variable was done. Male gender, being a difficult to treat patient and previous interferon therapy were significant predictors of nonresponse in both treatment groups. Results of sofosbuvir-based therapies in Egypt achieved similar rates of SVR12 as seen in phase III efficacy studies. © 2017 John Wiley & Sons Ltd.

Sublingual vs. Oral Captopril in Hypertensive Crisis.

PubMed

Kaya, Adnan; Tatlisu, Mustafa Adem; Kaplan Kaya, Tugba; Yildirimturk, Ozlem; Gungor, Baris; Karatas, Baran; Yazici, Selcuk; Keskin, Muhammed; Avsar, Sahin; Murat, Ahmet

2016-01-01

There are confusing data in literature regarding oral and sublingual captopril effects over blood pressure (BP) decrease. In our study we compared oral and sublingual captopril effectiveness over BP decrease in patients admitted to our Emergency Department with hypertensive urgency. Our study was conducted from January 2012 to January 2013 in patients with hypertensive urgency. In this cross-sectional study after two initial BP measurements, patients were identified as eligible for the study. An initial electrocardiogram was obtained and blood samples were drawn. A total of 212 patients were accepted as eligible for the study, and 25 mg of captopril was randomly given orally or sublingually; BP was measured at 10, 30, and 60 min. We selected the patients to the groups consecutively. A 25% reduction of initial BP 1 h after initiation of the treatment was accepted as an accomplishment. A second 25 mg of captopril was given if the target of 25% reduction of BP was not reached after the first tablet. Intravenous drugs were administered to the patients resistant to the captopril and these patients were excluded from the study. The 10-min systolic BP (SBP), diastolic BP, and mean BP (MBP) decrease was more prominent in the sublingual captopril group (p < 0.001). This decrease was statistically significant in the SBP and MBP at 30 min (p < 0.001), and no statistical difference was recorded at 60 min (p > 0.05). In our study, sublingual captopril was found to decrease BP more efficiently in the first 30 min, but this difference equalized at 60 min. Copyright © 2016 Elsevier Inc. All rights reserved.

PHI and PCA3 improve the prognostic performance of PRIAS and Epstein criteria in predicting insignificant prostate cancer in men eligible for active surveillance.

PubMed

Cantiello, Francesco; Russo, Giorgio Ivan; Cicione, Antonio; Ferro, Matteo; Cimino, Sebastiano; Favilla, Vincenzo; Perdonà, Sisto; De Cobelli, Ottavio; Magno, Carlo; Morgia, Giuseppe; Damiano, Rocco

2016-04-01

To assess the performance of prostate health index (PHI) and prostate cancer antigen 3 (PCA3) when added to the PRIAS or Epstein criteria in predicting the presence of pathologically insignificant prostate cancer (IPCa) in patients who underwent radical prostatectomy (RP) but eligible for active surveillance (AS). An observational retrospective study was performed in 188 PCa patients treated with laparoscopic or robot-assisted RP but eligible for AS according to Epstein or PRIAS criteria. Blood and urinary specimens were collected before initial prostate biopsy for PHI and PCA3 measurements. Multivariate logistic regression analyses and decision curve analysis were carried out to identify predictors of IPCa using the updated ERSPC definition. At the multivariate analyses, the inclusion of both PCA3 and PHI significantly increased the accuracy of the Epstein multivariate model in predicting IPCa with an increase of 17 % (AUC = 0.77) and of 32 % (AUC = 0.92), respectively. The inclusion of both PCA3 and PHI also increased the predictive accuracy of the PRIAS multivariate model with an increase of 29 % (AUC = 0.87) and of 39 % (AUC = 0.97), respectively. DCA revealed that the multivariable models with the addition of PHI or PCA3 showed a greater net benefit and performed better than the reference models. In a direct comparison, PHI outperformed PCA3 performance resulting in higher net benefit. In a same cohort of patients eligible for AS, the addition of PHI and PCA3 to Epstein or PRIAS models improved their prognostic performance. PHI resulted in greater net benefit in predicting IPCa compared to PCA3.

Experience With Direct-to-Patient Recruitment for Enrollment Into a Clinical Trial in a Rare Disease: A Web-Based Study

PubMed Central

2017-01-01

Background The target sample size for clinical trials often necessitates a multicenter (center of excellence, CoE) approach with associated added complexity, cost, and regulatory requirements. Alternative recruitment strategies need to be tested against this standard model. Objectives The aim of our study was to test whether a Web-based direct recruitment approach (patient-centric, PC) using social marketing strategies provides a viable option to the CoE recruitment method. Methods PC recruitment and Web-based informed consent was compared with CoE recruitment for a randomized controlled trial (RCT) of continuing versus stopping low-dose prednisone for maintenance of remission of patients with granulomatosis with polyangiitis (GPA). Results The PC approach was not as successful as the CoE approach. Enrollment of those confirmed eligible by their physician was 10 of 13 (77%) and 49 of 51 (96%) in the PC and CoE arms, respectively (P=.05). The two approaches were not significantly different in terms of eligibility with 34% of potential participants in the CoE found to be ineligible as compared with 22% in the PC arm (P=.11) nor in provider acceptance, 22% versus 26% (P=.78). There was no difference in the understanding of the trial as reflected in the knowledge surveys of individuals in the PC and CoE arms. Conclusions PC recruitment was substantially less successful than that achieved by the CoE approach. However, the PC approach was good at confirming eligibility and was as acceptable to providers and as understandable to patients as the CoE approach. The PC approach should be evaluated in other clinical settings to get a better sense of its potential. PMID:28246067

Validity and reliability of the de Morton Mobility Index in the subacute hospital setting in a geriatric evaluation and management population.

PubMed

de Morton, Natalie A; Lane, Kylie

2010-11-01

To investigate the clinimetric properties of the de Morton Mobility Index (DEMMI) in a Geriatric Evaluation and Management (GEM) population. A longitudinal validation study (n = 100) and inter-rater reliability study (n = 29) in a GEM population. Consecutive patients admitted to a GEM rehabilitation ward were eligible for inclusion. At hospital admission and discharge, a physical therapist assessed patients with physical performance instruments that included the 6-metre walk test, step test, Clinical Test of Sensory Organization and Balance, Timed Up and Go test, 6-minute walk test and the DEMMI. Consecutively eligible patients were included in an inter-rater reliability study between physical therapists. DEMMI admission scores were normally distributed (mean 30.2, standard deviation 16.7) and other activity limitation instruments had either a floor or a ceiling effect. Evidence of convergent, discriminant and known groups validity for the DEMMI were obtained. The minimal detectable change with 90% confidence was 10.5 (95% confidence interval 6.1-17.9) points and the minimally clinically important difference was 8.4 points on the 100-point interval DEMMI scale. The DEMMI provides clinicians with an accurate and valid method of measuring mobility for geriatric patients in the subacute hospital setting.

IMPACT OF RETINOPATHY SCREENINGS FOR PROSPECTIVE HEART TRANSPLANT CANDIDATES.

PubMed

Simon, Shira S; Wilcox, Jane E; Lyon, Alice T; Jampol, Lee M

2017-01-01

To determine the prevalence of retinopathy among patients undergoing heart transplantation screening and to determine the impact of this finding on eligibility for transplantation. A retrospective case series was collected to perform an institutional review of all inpatient consults for dilated eye examinations on potential heart transplant candidates over 5.5 years-from March 27, 2008 to October 10, 2014. Measured outcomes included the presence or absence of retinopathy and the effect of retinopathy, if present, on a patient's eligibility for cardiac transplantation. A total of 155 heart transplant candidates underwent bedside ophthalmologic examination as part of their heart transplant candidacy workup. Retinopathy was found in 16 (10%) of these patients: diabetic retinopathy in 13 (8.4%) and hypertensive retinopathy in 3 (1.9%). None of these patients were excluded from the transplant candidacy based on the presence of retinopathy. On bedside ophthalmologic examination, retinopathy is an uncommon finding among cardiac transplant candidates. Retinopathy did not preclude transplantation in these patients. We question the utility of the present system of bedside ophthalmic consultation of heart transplant candidates. This may not be an optimal allocation of provider resources. Further studies are warranted to determine an appropriate protocol for ocular evaluation of these patients.

Does structured patient education improve the recovery and clinical outcomes of patients with neck pain? A systematic review from the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration.

PubMed

Yu, Hainan; Côté, Pierre; Southerst, Danielle; Wong, Jessica J; Varatharajan, Sharanya; Shearer, Heather M; Gross, Douglas P; van der Velde, Gabrielle M; Carroll, Linda J; Mior, Silvano A; Ameis, Arthur; Jacobs, Craig L; Taylor-Vaisey, Anne L

2016-12-01

In 2008, the Bone and Joint Decade 2000 to 2010 Task Force on Neck Pain and Its Associated Disorders recommended patient education for the management of neck pain. However, the effectiveness of education interventions has recently been challenged. To update the findings of the Bone and Joint Decade 2000 to 2010 Task Force on Neck Pain and Its Associated Disorders and evaluate the effectiveness of structured patient education for the management of patients with whiplash-associated disorders (WAD) or neck pain and associated disorders (NAD). Systematic review of the literature and best-evidence synthesis. Randomized controlled trials that compared structured patient education with other conservative interventions. Self-rated recovery, functional recovery (eg, disability, return to activities, work, or school), pain intensity, health-related quality of life, psychological outcomes such as depression or fear, or adverse effects. We systematically searched eight electronic databases (MEDLINE, EMBASE, CINAHL, PsycINFO, the Cochrane Central Register of Controlled Trials, DARE, PubMed, and ICL) from 2000 to 2012. Randomized controlled trials, cohort studies, and case-control studies meeting our selection criteria were eligible for critical appraisal. Random pairs of independent reviewers critically appraised eligible studies using the Scottish Intercollegiate Guidelines Network criteria. Scientifically admissible studies were summarized in evidence tables and synthesized following best-evidence synthesis principles. We retrieved 4,477 articles. Of those, nine were eligible for critical appraisal and six were scientifically admissible. Four admissible articles investigated patients with WAD and two targeted patients with NAD. All structured patient education interventions included advice on activation or exercises delivered orally combined with written information or as written information alone. Overall, as a therapeutic intervention, structured patient education was equal or less effective than other conservative treatments including massage, supervised exercise, and physiotherapy. However, structured patient education may provide small benefits when combined with physiotherapy. Either mode of delivery (ie, oral or written education) provides similar results in patients with recent WAD. This review adds to the Bone and Joint Decade 2000 to 2010 Task Force on Neck Pain and Its Associated Disorders by defining more specifically the role of structured patient education in the management of WAD and NAD. Results suggest that structured patient education alone cannot be expected to yield large benefits in clinical effectiveness compared with other conservative interventions for patients with WAD or NAD. Moreover, structured patient education may be of benefit during the recovery of patients with WAD when used as an adjunct therapy to physiotherapy or emergency room care. These benefits are small and short lived. Copyright © 2014 Elsevier Inc. All rights reserved.

Lung protective mechanical ventilation and two year survival in patients with acute lung injury: prospective cohort study.

PubMed

Needham, Dale M; Colantuoni, Elizabeth; Mendez-Tellez, Pedro A; Dinglas, Victor D; Sevransky, Jonathan E; Dennison Himmelfarb, Cheryl R; Desai, Sanjay V; Shanholtz, Carl; Brower, Roy G; Pronovost, Peter J

2012-04-05

To evaluate the association of volume limited and pressure limited (lung protective) mechanical ventilation with two year survival in patients with acute lung injury. Prospective cohort study. 13 intensive care units at four hospitals in Baltimore, Maryland, USA. 485 consecutive mechanically ventilated patients with acute lung injury. Two year survival after onset of acute lung injury. 485 patients contributed data for 6240 eligible ventilator settings, as measured twice daily (median of eight eligible ventilator settings per patient; 41% of which adhered to lung protective ventilation). Of these patients, 311 (64%) died within two years. After adjusting for the total duration of ventilation and other relevant covariates, each additional ventilator setting adherent to lung protective ventilation was associated with a 3% decrease in the risk of mortality over two years (hazard ratio 0.97, 95% confidence interval 0.95 to 0.99, P=0.002). Compared with no adherence, the estimated absolute risk reduction in two year mortality for a prototypical patient with 50% adherence to lung protective ventilation was 4.0% (0.8% to 7.2%, P=0.012) and with 100% adherence was 7.8% (1.6% to 14.0%, P=0.011). Lung protective mechanical ventilation was associated with a substantial long term survival benefit for patients with acute lung injury. Greater use of lung protective ventilation in routine clinical practice could reduce long term mortality in patients with acute lung injury. Clinicaltrials.gov NCT00300248.

Clinical evaluation of the use of an intracardiac electrocardiogram to guide the tip positioning of peripherally inserted central catheters.

PubMed

Zhao, Ruiyi; Chen, Chunfang; Jin, Jingfen; Sharma, Komal; Jiang, Nan; Shentu, Yingqin; Wang, Xingang

2016-06-01

The use of peripherally inserted central catheters (PICCs) provides important central venous accesses for clinical treatments, tests and monitoring. Compared with the traditional methods, intracardiac electrocardiogram (ECG)-guided method has the potential to guide more accurate tip positioning of PICCs. This study aimed to clinically evaluate the effectiveness of an intracardiac ECG to guide the tip positioning by monitoring characteristic P-wave changes. In this study, eligible patients enrolled September 2011 to May 2012 according to the inclusion and exclusion criteria received the catheterization monitored by intracardiac ECG. Then chest radiography was performed to check the catheter position. The results revealed that, with 117 eligible patients, all bar one patient who died (n = 116) completed the study, including 60 males and 56 females aged 51.2 ± 15.1 years. Most (n = 113, > 97%) had characteristic P-wave changes. The intracardiac ECG-guided positioning procedure achieved correct placement for 112 patients (96.56%), demonstrating 99.12% sensitivity and 100% specificity. In conclusion, the intracardiac ECG can be a promising technique to guide tip positioning of PICCs. However, since the sample size in this study is limited, more experience and further study during clinical practice are needed to demonstrate achievement of optimal catheterization outcomes. © 2015 John Wiley & Sons Australia, Ltd.

FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): protocol for a multicentre randomised feasibility trial of non-invasive respiratory support in critically ill children.

PubMed

Ramnarayan, Padmanabhan; Lister, Paula; Dominguez, Troy; Habibi, Parviz; Edmonds, Naomi; Canter, Ruth; Mouncey, Paul; Peters, Mark J

2017-06-12

Over 18 000 children are admitted annually to UK paediatric intensive care units (PICUs), of whom nearly 75% receive respiratory support (invasive and/or non-invasive). Continuous positive airway pressure (CPAP) has traditionally been used to provide first-line non-invasive respiratory support (NRS) in PICUs; however, high-flow nasal cannula therapy (HFNC), a novel mode of NRS, has recently gained popularity despite the lack of high-quality trial evidence to support its effectiveness. This feasibility study aims to inform the design and conduct of a future definitive randomised clinical trial (RCT) comparing the two modes of respiratory support. We will conduct a three-centre randomised feasibility study over 12 months. Patients admitted to participating PICUs who satisfy eligibility criteria will be recruited to either group A (primary respiratory failure) or group B (postextubation). Consent will be obtained from parents/guardians prior to randomisation in 'planned' group B, and deferred in emergency situations (group A and 'rescue' group B). Participants will be randomised (1:1) to either CPAP or HFNC using sealed, opaque envelopes, from a computer-generated randomisation sequence with variable block sizes. The study protocol specifies algorithms for the initiation, maintenance and weaning of HFNC and CPAP. The primary outcomes are related to feasibility, including the number of eligible patients in each group, feasibility of randomising >50% of eligible patients and measures of adherence to the treatment protocols. Data will also be collected on patient outcomes (eg, mortality and length of PICU stay) to inform the selection of an appropriate outcome measure in a future RCT. We aim to recruit 120 patients to the study. Ethical approval was granted by the National Research Ethics Service Committee North East-Tyne&Wear South (15/NE/0296). Study findings will be disseminated through peer-reviewed journals, national and international conferences. NCT02612415; pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): protocol for a multicentre randomised feasibility trial of non-invasive respiratory support in critically ill children

PubMed Central

Ramnarayan, Padmanabhan; Lister, Paula; Dominguez, Troy; Habibi, Parviz; Edmonds, Naomi; Canter, Ruth; Mouncey, Paul; Peters, Mark J

2017-01-01

Introduction Over 18 000 children are admitted annually to UK paediatric intensive care units (PICUs), of whom nearly 75% receive respiratory support (invasive and/or non-invasive). Continuous positive airway pressure (CPAP) has traditionally been used to provide first-line non-invasive respiratory support (NRS) in PICUs; however, high-flow nasal cannula therapy (HFNC), a novel mode of NRS, has recently gained popularity despite the lack of high-quality trial evidence to support its effectiveness. This feasibility study aims to inform the design and conduct of a future definitive randomised clinical trial (RCT) comparing the two modes of respiratory support. Methods and analysis We will conduct a three-centre randomised feasibility study over 12 months. Patients admitted to participating PICUs who satisfy eligibility criteria will be recruited to either group A (primary respiratory failure) or group B (postextubation). Consent will be obtained from parents/guardians prior to randomisation in ‘planned’ group B, and deferred in emergency situations (group A and ‘rescue’ group B). Participants will be randomised (1:1) to either CPAP or HFNC using sealed, opaque envelopes, from a computer-generated randomisation sequence with variable block sizes. The study protocol specifies algorithms for the initiation, maintenance and weaning of HFNC and CPAP. The primary outcomes are related to feasibility, including the number of eligible patients in each group, feasibility of randomising >50% of eligible patients and measures of adherence to the treatment protocols. Data will also be collected on patient outcomes (eg, mortality and length of PICU stay) to inform the selection of an appropriate outcome measure in a future RCT. We aim to recruit 120 patients to the study. Ethics and dissemination Ethical approval was granted by the National Research Ethics Service Committee North East—Tyne&Wear South (15/NE/0296). Study findings will be disseminated through peer-reviewed journals, national and international conferences. Trials registration number NCT02612415; pre-results. PMID:28606907

Multi-month prescriptions, fast-track refills, and community ART groups: results from a process evaluation in Malawi on using differentiated models of care to achieve national HIV treatment goals.

PubMed

Prust, Margaret L; Banda, Clement K; Nyirenda, Rose; Chimbwandira, Frank; Kalua, Thokozani; Jahn, Andreas; Eliya, Michael; Callahan, Katie; Ehrenkranz, Peter; Prescott, Marta R; McCarthy, Elizabeth A; Tagar, Elya; Gunda, Andrews

2017-07-21

In order to facilitate scale-up of antiretroviral therapy (ART) in Malawi, innovative and pragmatic models have been developed to optimize the efficiency of HIV service delivery. In particular, three models of differentiated care have emerged for stable patients: adjusted appointment spacing through multi-month scripting (MMS); fast-track drug refills (FTRs) on alternating visits; and community ART groups (CAGs) where group members rotate in collecting medications at the facility for all members. This study aimed to assess the extent to which ART patients in Malawi are differentiated based on clinical stability and describe the characteristics and costs associated with the models of differentiated care offered. A mixed methods process evaluation was conducted from 30 purposefully selected ART facilities. Cross-sectional data for this evaluation was collected between February and May 2016. The following forms of data collection are reported here: structured surveys with 136 health care workers; reviews of 75,364 patient clinical records; 714 observations of visit time and flow; and 30 questionnaires on facility characteristics. Among ART patients, 77.5% (95% confidence interval [CI] 74.1-80.6) were eligible for differentiated models of care based on criteria for clinical stability from national guidelines. Across all facilities, 69% of patients were receiving MMS. In facilities offering FTRs and CAGs, 67% and 6% of patients were enrolled in the models, respectively. However, eligibility criteria were used inconsistently: 72.9% (95% CI 66.3-78.6) of eligible patients and 42.3% (95% CI 33.1-52.0) ineligible patients received MMS. Results indicated that patient travel and time costs were reduced by 67%, and the unit costs of ART service delivery through the MMS, FTR and CAG models were similar, representing a reduction of approximately 10% in the annual unit cost of providing care to stable patients that receive no model. MMS is being implemented nationally and has already generated cost savings and efficiencies in Malawi for patients and the health system, but could be improved by more accurate patient differentiation. While expanding FTRs and CAGs may not offer significant further cost savings in Malawi, future studies should investigate if such alternative models lead to improvements in patient satisfaction or clinical outcomes that might justify their implementation.

Why take the chance? A qualitative grounded theory study of nocturnal haemodialysis recipients who decline kidney transplantation.

PubMed

Rosenthal, Meagen M; Molzahn, Anita E; Chan, Christopher T; Cockfield, Sandra L; Kim, S Joseph; Pauly, Robert P

2016-05-18

The objective of this study was to examine the factors that influence decision-making to forgo transplantation in favour of remaining on nocturnal haemodialysis (NHD). A grounded theory approach using in-depth telephone interviewing was used. Participants were identified from 2 tertiary care renal programmes in Canada. The study participants were otherwise eligible patients with end-stage renal disease who have opted to remain off of the transplant list. A total of 7 eligible participants were interviewed. 5 were male. The mean age was 46 years. A constant comparative method of analysis was used to identify a core category and factors influencing the decision-making process. In this grounded theory study of people receiving NHD who refused kidney transplantation, the core category of 'why take a chance when things are going well?' was identified, along with 4 factors that influenced the decision including 'negative past experience', 'feeling well on NHD', 'gaining autonomy' and 'responsibility'. This study provides insight into patients' thought processes surrounding an important treatment decision. Such insights might help the renal team to better understand, and thereby respect, patient choice in a patient-centred care paradigm. Findings may also be useful in the development of education programmes addressing the specific concerns of this population of patients. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Early-switch/early-discharge opportunities for hospitalized patients with methicillin-resistant Staphylococcus aureus complicated skin and soft tissue infections: proof of concept in the United Arab Emirates.

PubMed

El Houfi, Ashraf; Javed, Nadeem; Solem, Caitlyn T; Macahilig, Cynthia; Stephens, Jennifer M; Raghubir, Nirvana; Chambers, Richard; Li, Jim Z; Haider, Seema

2015-01-01

To describe real-world treatment patterns and health care resource use and to estimate opportunities for early-switch (ES) from intravenous (IV) to oral (PO) antibiotics and early-discharge (ED) for patients hospitalized in the United Arab Emirates (UAE) with methicillin-resistant Staphylococcus aureus (MRSA) complicated skin and soft tissue infections. This retrospective observational medical chart review study enrolled physicians from four UAE sites to collect data for 24 patients with documented MRSA complicated skin and soft tissue infections, hospitalized between July 2010 and June 2011, and discharged alive by July 2011. Data include clinical characteristics and outcomes, hospital length of stay (LOS), MRSA-targeted IV and PO antibiotic use, and ES and ED eligibility using literature-based and expert-validated criteria. Five included patients (20.8%) were switched from IV to PO antibiotics while being inpatients. Actual length of MRSA-active treatment was 10.8±7.0 days, with 9.8±6.6 days of IV therapy. Patients were hospitalized for a mean 13.9±9.3 days. The most frequent initial MRSA-active therapies used were vancomycin (37.5%), linezolid (16.7%), and clindamycin (16.7%). Eight patients were discharged with MRSA-active antibiotics, with linezolid prescribed most frequently (n=3; 37.5%). Fifteen patients (62.5%) met ES criteria and potentially could have discontinued IV therapy 8.3±6.0 days sooner, and eight (33.3%) met ED criteria and potentially could have been discharged 10.9±5.8 days earlier. While approximately one-fifth of patients were switched from IV to PO antibiotics in the UAE, there were clear opportunities for further optimization of health care resource use. Over half of UAE patients hospitalized for MRSA complicated skin and soft tissue infections could be eligible for ES, with one-third eligible for ED opportunities, resulting in substantial potential for reductions in IV days and bed days.

Practice Patterns for Chronic Respiratory Diseases in the Asia-Pacific Region: A Cross-Sectional Observational Study.

PubMed

Wang, De Yun; Cho, Sang-Heon; Lin, Horng-Chyuan; Ghoshal, Aloke Gopal; Bin Abdul Muttalif, Abdul Razak; Thanaviratananich, Sanguansak; Tunceli, Kaan; Urdaneta, Eduardo; Zhang, Dongmu; Faruqi, Rab

2018-06-06

Allergic rhinitis (AR), asthma, chronic obstructive pulmonary disease (COPD), and rhinosinusitis are common and little studied in the Asia-Pacific region. We sought to investigate real-world practice patterns for these respiratory diseases in India, Korea, Malaysia, Singapore, Taiwan, and Thailand. This cross-sectional observational study enrolled adults (age ≥18 years) presenting to general practitioners (GP) or specialists for physician-diagnosed AR, asthma, COPD, or rhinosinusitis. Physicians and patients completed study-specific surveys at one visit, recording patient characteristics, health-related quality of life (QoL), work impairment, and healthcare resource use. Findings by country and physician category (GP or specialist) were summarized. Of the 13,902 patients screened, 7,243 (52%) presented with AR (18%), asthma (18%), COPD (7%), or rhinosinusitis (9%); 5,250 of the 7,243 (72%) patients were eligible for this study. Most eligible patients (70-100%) in India, Korea, Malaysia, and Singapore attended GP, while most (83-85%) in Taiwan and Thailand attended specialists. From 42% (rhinosinusitis) to 67% (AR) of new diagnoses were made by GP. On average, patients with COPD reported the worst health-related QoL, particularly to GP. Median losses of work productivity for each condition and activity impairment, except for asthma, were numerically greater for patients presenting to GP vs. specialists. GP prescribed more antibiotics for AR and asthma, and fewer intranasal corticosteroids for AR, than specialists (p < 0.001 for all comparisons). Our findings, albeit mostly descriptive and influenced by between-country differences, suggest that practice patterns differ between physician types, and the disease burden may be substantial for patients presenting in general practice. © 2018 S. Karger AG, Basel.

Exploratory cohort study and meta-analysis of BIM deletion polymorphism in patients with epidermal growth factor receptor-mutant non-small-cell lung cancer treated with epidermal growth factor receptor tyrosine kinase inhibitors

PubMed Central

Sun, Si; Yu, Hui; Wang, Huijie; Zhao, Xinmin; Zhao, Xintai; Wu, Xianghua; Qiao, Jie; Chang, Jianhua; Wang, Jialei

2017-01-01

Background Non-small-cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations might develop primary and secondary resistance to tyrosine kinase inhibitors (TKIs). The proapoptotic protein Bcl-2-like 11 (BIM) is a key modulator of apoptosis triggered by EGFR-TKIs. The recent studies have indicated that some patients with positive EGFR mutations were refractory to EGFR-TKIs if they harbored a BIM deletion polymorphism. The purpose of this study was to investigate whether BIM polymorphism predicts treatment efficacy of EGFR-TKIs in Chinese NSCLC patients. Patients and methods A cohort of advanced NSCLC patients with EGFR mutations and treated with EGFR-TKIs (gefitinib or erlotinib) were recruited. We drew peripheral blood to determinate BIM deletion status and then compared patients’ clinical outcomes according to the BIM deletion status. Additionally, we electronically searched eligible cohort studies and conducted a meta-analysis to pool event risk. Results The exploratory cohort study included 140 patients. Patients with and without the BIM deletion polymorphism had similar objective response rates (ORRs, 48.5 vs 63.0%, P=0.16), disease control rate (DCR, 93.9 vs 97.0%, P=0.60) and adverse reactions. Similar progression-free survival (PFS) and overall survival (OS) were noted in overall population (P=0.27 for PFS and P=0.61 for OS) and prespecified patient subgroups. The meta-analysis included 10 eligible cohort studies involving 1,317 NSCLC patients. It showed the positive BIM deletion was associated with shorter PFS (hazard ratio =1.45; P=0.02). Nonsignificant differences existed for ORR, DCR and OS. Conclusion The expanded meta-analysis results demonstrated the positive BIM deletion predicts shorter PFS in NSCLC patients after treatment with EGFR-TKIs while other clinical measures do not. A large multicenter well-designed cohort study involving other concurrent genetic alterations is warranted. PMID:28435285

Exploratory cohort study and meta-analysis of BIM deletion polymorphism in patients with epidermal growth factor receptor-mutant non-small-cell lung cancer treated with epidermal growth factor receptor tyrosine kinase inhibitors.

PubMed

Sun, Si; Yu, Hui; Wang, Huijie; Zhao, Xinmin; Zhao, Xintai; Wu, Xianghua; Qiao, Jie; Chang, Jianhua; Wang, Jialei

2017-01-01

Non-small-cell lung cancer (NSCLC) patients with epidermal growth factor receptor ( EGFR ) mutations might develop primary and secondary resistance to tyrosine kinase inhibitors (TKIs). The proapoptotic protein Bcl-2-like 11 (BIM) is a key modulator of apoptosis triggered by EGFR-TKIs. The recent studies have indicated that some patients with positive EGFR mutations were refractory to EGFR-TKIs if they harbored a BIM deletion polymorphism. The purpose of this study was to investigate whether BIM polymorphism predicts treatment efficacy of EGFR-TKIs in Chinese NSCLC patients. A cohort of advanced NSCLC patients with EGFR mutations and treated with EGFR-TKIs (gefitinib or erlotinib) were recruited. We drew peripheral blood to determinate BIM deletion status and then compared patients' clinical outcomes according to the BIM deletion status. Additionally, we electronically searched eligible cohort studies and conducted a meta-analysis to pool event risk. The exploratory cohort study included 140 patients. Patients with and without the BIM deletion polymorphism had similar objective response rates (ORRs, 48.5 vs 63.0%, P =0.16), disease control rate (DCR, 93.9 vs 97.0%, P =0.60) and adverse reactions. Similar progression-free survival (PFS) and overall survival (OS) were noted in overall population ( P =0.27 for PFS and P =0.61 for OS) and prespecified patient subgroups. The meta-analysis included 10 eligible cohort studies involving 1,317 NSCLC patients. It showed the positive BIM deletion was associated with shorter PFS (hazard ratio =1.45; P =0.02). Nonsignificant differences existed for ORR, DCR and OS. The expanded meta-analysis results demonstrated the positive BIM deletion predicts shorter PFS in NSCLC patients after treatment with EGFR-TKIs while other clinical measures do not. A large multicenter well-designed cohort study involving other concurrent genetic alterations is warranted.

Tamoxifen in the treatment of advanced or recurrent endometrial carcinoma: a Gynecologic Oncology Group study.

PubMed

Thigpen, T; Brady, M F; Homesley, H D; Soper, J T; Bell, J

2001-01-15

In two large Gynecologic Oncology Group studies of patients with advanced or recurrent endometrial carcinoma and no previous systemic therapy, progestins have demonstrated activity against advanced or recurrent endometrial carcinoma with response rates between 15% and 25%. Tamoxifen has been reported as variously active or inactive with or without previous systemic therapy. The purpose of this study was to determine whether tamoxifen exhibits enough activity in patients with advanced or recurrent endometrial carcinoma, who have not received systemic therapy, to warrant a phase III trial. Sixty-eight eligible patients with advanced or recurrent endometrial carcinoma received oral tamoxifen 20 mg bid until toxicity was unacceptable or disease progressed. Three complete (4%) and four partial (6%) responses were observed for an overall response rate of 10% (90% confidence interval [CI], 5.7% to 17.9%). Patients with tumors that were more anaplastic tended to respond less frequently. The median progression-free survival for all 68 eligible patients was 1.9 months (90% CI, 1.7 to 3.2 months). The median survival was 8.8 months (90% CI, 7.0 to 10.1 months). Tamoxifen demonstrated modest activity at best against endometrial carcinoma and does not warrant further investigation as a single agent for this disease. Ongoing trials will assess the sequential use of tamoxifen and progestational agents.

A Phase I study of bizelesin (NSC 615291) in patients with advanced solid tumors.

PubMed

Pitot, Henry C; Reid, Joel M; Sloan, Jeff A; Ames, Matthew M; Adjei, Alex A; Rubin, Joseph; Bagniewski, Pamela G; Atherton, Pamela; Rayson, Daniel; Goldberg, Richard M; Erlichman, Charles

2002-03-01

To evaluate the toxicities, characterize the pharmacokinetics, and determine the maximum-tolerated dose of bizelesin administered once every 4 weeks. Patients with advanced solid tumors received escalating doses of bizelesin as an i.v. push every 4 weeks. Pharmacokinetic studies were performed with the first treatment cycle. Nineteen eligible patients received a total of 54 courses of bizelesin at doses ranging from 0.1 to 1 microg/m(2). Dose-limiting toxicity of neutropenia was seen in 2 of 4 patients treated at the 1 microg/m(2) dose level. Nonhematological toxicity was generally mild with maximum toxicity being

Hydroxyurea for nontransfusion-dependent β-thalassemia: A systematic review and meta-analysis.

PubMed

Algiraigri, Ali H; Wright, Nicola A M; Paolucci, Elizabeth Oddone; Kassam, Aliya

2017-09-01

Nontransfusion-dependent β-thalassemia (NTDβT) syndromes consist of β-thalassemia intermedia and moderate hemoglobin E/β thalassemias. They are characterized by varying degrees of chronic anemia and a wide spectrum of complications due to ineffective erythropoiesis and iron overload from chronic transfusions. Hydroxyurea (HU), an oral chemotherapeutic drug, is anticipated to decrease disease severity. We performed a meta-analysis to evaluate the clinical efficacy and safety of HU in NTDβT patients of any age. MEDLINE, EMBASE, Cochrane databases, and major conference proceedings for studies that assessed HU in NTDβT patients were searched. Qualities of eligible studies were assessed by National Institutes of Health tools. Seventeen studies, collectively involving 709 patients, fulfilled the eligibility criteria. HU was associated with a significant decrease in transfusion need in severe NTDβT with complete and overall (≥50%) response rates of 42% and 79%, respectively. For mild NTDβT, HU was effective in raising hemoglobin by 1g/L in 64% of patients. HU appears to be effective, well tolerated, and associated with mild and transient adverse events. NTDβT patients may benefit from a trial of HU, although large randomized clinical trials assessing its efficacy should be conducted to confirm the findings of this meta-analysis and to assess its long-term toxicity and response sustainability. Copyright © 2017 King Faisal Specialist Hospital & Research Centre. Published by Elsevier B.V. All rights reserved.

Is undertransfusion a problem in modern clinical practice?

PubMed

Hibbs, Stephen; Miles, David; Staves, Julie; Murphy, Michael F

2015-04-01

Significant progress has been made in reducing inappropriate transfusion of blood products. However, there is also a need to monitor for their underutilization in patients who would benefit from transfusion. This study aimed to develop a method to monitor for undertransfusion and conduct a preliminary examination of whether it is a problem in modern clinical practice. All patients with a hemoglobin (Hb) concentration below 6 g/dL or platelet (PLT) count of fewer than 10 × 10(9) /L were identified during a 1-month period in an academic medical center in the United Kingdom. Patients who were transfused within 72 hours of the low reading were excluded from further analysis. For all other patients, records were examined against predefined criteria to ascertain whether the reason for nonadministration of transfusion was justified. During the study period there were 63 eligible Hb readings and 130 eligible PLT counts in 93 patients. Of these, 36 patients were not transfused within 72 hours of the low reading. The majority of nonadministration (n = 28) was justified by either an additional Hb or an additional PLT count on repeat sampling being above the transfusion threshold or the transfusion being medically inappropriate. No documentation was found to indicate that any cases of nonadministration of blood were unjustified. This study did not find that patients with low Hb readings or PLT counts were inappropriately undertransfused. However, systems similar to those described in this study should be developed to monitor for inappropriate undertransfusion as well as continuing efforts to monitor for and reduce inappropriate overtransfusion. © 2014 AABB.

Ambulance Clinical Triage for Acute Stroke Treatment: Paramedic Triage Algorithm for Large Vessel Occlusion.

PubMed

Zhao, Henry; Pesavento, Lauren; Coote, Skye; Rodrigues, Edrich; Salvaris, Patrick; Smith, Karen; Bernard, Stephen; Stephenson, Michael; Churilov, Leonid; Yassi, Nawaf; Davis, Stephen M; Campbell, Bruce C V

2018-04-01

Clinical triage scales for prehospital recognition of large vessel occlusion (LVO) are limited by low specificity when applied by paramedics. We created the 3-step ambulance clinical triage for acute stroke treatment (ACT-FAST) as the first algorithmic LVO identification tool, designed to improve specificity by recognizing only severe clinical syndromes and optimizing paramedic usability and reliability. The ACT-FAST algorithm consists of (1) unilateral arm drift to stretcher <10 seconds, (2) severe language deficit (if right arm is weak) or gaze deviation/hemineglect assessed by simple shoulder tap test (if left arm is weak), and (3) eligibility and stroke mimic screen. ACT-FAST examination steps were retrospectively validated, and then prospectively validated by paramedics transporting culturally and linguistically diverse patients with suspected stroke in the emergency department, for the identification of internal carotid or proximal middle cerebral artery occlusion. The diagnostic performance of the full ACT-FAST algorithm was then validated for patients accepted for thrombectomy. In retrospective (n=565) and prospective paramedic (n=104) validation, ACT-FAST displayed higher overall accuracy and specificity, when compared with existing LVO triage scales. Agreement of ACT-FAST between paramedics and doctors was excellent (κ=0.91; 95% confidence interval, 0.79-1.0). The full ACT-FAST algorithm (n=60) assessed by paramedics showed high overall accuracy (91.7%), sensitivity (85.7%), specificity (93.5%), and positive predictive value (80%) for recognition of endovascular-eligible LVO. The 3-step ACT-FAST algorithm shows higher specificity and reliability than existing scales for clinical LVO recognition, despite requiring just 2 examination steps. The inclusion of an eligibility step allowed recognition of endovascular-eligible patients with high accuracy. Using a sequential algorithmic approach eliminates scoring confusion and reduces assessment time. Future studies will test whether field application of ACT-FAST by paramedics to bypass suspected patients with LVO directly to endovascular-capable centers can reduce delays to endovascular thrombectomy. © 2018 American Heart Association, Inc.

Patient and medication factors associated with preventable medication waste and possibilities for redispensing.

PubMed

Bekker, C L; van den Bemt, B J F; Egberts, A C G; Bouvy, M L; Gardarsdottir, H

2018-05-02

Background Knowledge on factors related to preventable medication waste and waste-reducing interventions, including redispensing unused medications, is needed to maximise effectiveness. Objective To assess patient and medication factors associated with preventable medication waste and possibilities for redispensing unused medications. Setting Dutch community pharmacies. Methods In this cross-sectional study, pharmacy-staff registered patient and medication characteristics of prescription medications returned to 41 Dutch community pharmacies during 1 week in 2014. Medications were classified as preventable waste if the remaining amount could have been prevented and as theoretically eligible for redispensing if the package was unopened, undamaged and ≥ 6 months until the expiry date. Associations were analysed using multivariate logistic regression. Main outcome measures Proportion of medications classified as preventable waste and as eligible for redispensing, including factors associated with these medications. Results Overall, 279 persons returned 759 (low-cost) medications, and 39.3% was classified as preventable waste. These medications were more frequently used by men than women (OR; 1.7[1.2-2.3]) and by older (> 65 years) than younger patients (OR; 1.4[1.0-2.0]). Medications dispensed for longer periods were more often unnecessary wasted (1-3 months OR; 1.8[1.1-3.0], > 3 months 3.2[1.5-6.9]). Of all returned medications, 19.1% was eligible for redispensing. These medications were more frequently used by men than women (OR; 1.9[1.3-2.9]). Medications chronically used were more frequently eligible for redispensing than acute use (OR; 2.1[1.0-4.3]), and used for longer periods (1-3 months OR; 4.6[2.3-8.9], > 3 months 7.8[3.3-18.5]). Conclusions Over one-third of waste due to medications returned to community pharmacies can be prevented. One-fifth of returned medications can be redispensed, but this seems less interesting from an economic viewpoint.

Barriers and facilitators to reducing frequent laboratory testing for patients who are stable on warfarin: a mixed methods study of de-implementation in five anticoagulation clinics.

PubMed

Barnes, Geoffrey D; Misirliyan, Sevan; Kaatz, Scott; Jackson, Elizabeth A; Haymart, Brian; Kline-Rogers, Eva; Kozlowski, Jay; Krol, Gregory; Froehlich, James B; Sales, Anne

2017-07-14

Patients on chronic warfarin therapy require regular laboratory monitoring to safely manage warfarin. Recent studies have challenged the need for routine monthly blood draws in the most stable warfarin-treated patients, suggesting the safety of less frequent laboratory testing (up to every 12 weeks). De-implementation efforts aim to reduce the use of low-value clinical practices. To explore barriers and facilitators of a de-implementation effort to reduce the use of frequent laboratory tests for patients with stable warfarin management in nurse/pharmacist-run anticoagulation clinics, we performed a mixed-methods study conducted within a state-wide collaborative quality improvement collaborative. Using a mixed-methods approach, we conducted post-implementation semi-structured interviews with a total of eight anticoagulation nurse or pharmacist staff members at five participating clinic sites to assess barriers and facilitators to de-implementing frequent international normalized ratio (INR) laboratory testing among patients with stable warfarin control. Interview guides were based on the Tailored Implementation for Chronic Disease (TICD) framework. Informed by interview themes, a survey was developed and administered to all anticoagulation clinical staff (n = 62) about their self-reported utilization of less frequent INR testing and specific barriers to de-implementing the standard (more frequent) INR testing practice. From the interviews, four themes emerged congruent with TICD domains: (1) staff overestimating their actual use of less frequent INR testing (individual health professional factors), (2) barriers to appropriate patient engagement (incentives and resources), (3) broad support for an electronic medical record flag to identify potentially eligible patients (incentives and resources), and (4) the importance of personalized nurse/pharmacist feedback (individual health professional factors). In the survey (65% response rate), staff report offering less frequent INR testing to 56% (46-66%) of eligible patients. Most survey responders (n = 24; 60%) agreed that an eligibility flag in the electronic medical record would be very helpful. Twenty-four (60%) respondents agreed that periodic, personalized feedback on use of less frequent INR testing would also be helpful. Leveraging information system notifications, reducing additional work load burden for participating patients and providers, and providing personalized feedback are strategies that may improve adoption and utilization new policies in anticoagulation clinics that focus on de-implementation.

Adjuvant Therapy With Zoledronic Acid in Patients With Breast Cancer: A Systematic Review and Meta-Analysis

PubMed Central

Polyzos, Nikolaos P.; Coleman, Robert E.; Gnant, Michael; Eidtmann, Holger; Brufsky, Adam M.; Aft, Rebecca; Tevaarwerk, Amye J.; Swenson, Karen; Lind, Pehr; Mauri, Davide

2013-01-01

Background. The purpose of the study was to estimate the impact on survival and fracture rates of the use of zoledronic acid versus no use (or delayed use) in the adjuvant treatment of patients with early-stage (stages I–III) breast cancer. Materials and Methods. We performed a systematic review and meta-analysis of randomized clinical trials. Trials were located through PubMed, ISI, Cochrane Library, and major cancer scientific meeting searches. All trials that randomized patients with primary breast cancer to undergo adjuvant treatment with zoledronic acid versus nonuse, placebo, or delayed use of zoledronic acid as treatment to individuals who develop osteoporosis were considered eligible. Standard meta-analytic procedures were used to analyze the study outcomes. Results. Fifteen studies were considered eligible and were further analyzed. The use of zoledronic acid resulted in a statistically significant better overall survival outcome (five studies, 6,414 patients; hazard ratio [HR], 0.81; 95% confidence interval [CI], 0.70–0.94). No significant differences were found for the disease-free survival outcome (seven studies, 7,541 patients; HR, 0.86; 95% CI, 0.70–1.06) or incidence of bone metastases (seven studies, 7,543 patients; odds ratio [OR], 0.94; 95% CI, 0.64–1.37). Treatment with zoledronic acid led to a significantly lower overall fracture rate (OR, 0.78; 95% CI, 0.63–0.96). Finally, the rate of osteonecrosis of the jaw was 0.52%. Conclusion. Zoledronic acid as adjuvant therapy in breast cancer patients appears to not only reduce the fracture risk but also offer a survival benefit over placebo or no treatment. PMID:23404816

Preoperative intra-aortic balloon pump in patients undergoing coronary bypass surgery: a systematic review and meta-analysis.

PubMed

Dyub, Adel M; Whitlock, Richard P; Abouzahr, Labib L; Cinà, Claudio S

2008-01-01

To assess the effectiveness of preoperative intra-aortic balloon pump (IABP) placement in high-risk patients undergoing coronary bypass surgery (CABG). The primary outcome was hospital mortality and secondary outcomes were IABP-related complications (bleeding, leg ischemia, aortic dissection). MEDLINE, EMBASE, Cochrane registry of Controlled Trials, and reference lists of relevant articles were searched. We included randomized controlled trials (RCTs), and cohort studies that fulfilled our a priori inclusion criteria. Eligibility decisions, relevance, study validity, and data extraction were performed in duplicate using pre-specified criteria. Meta-analysis was conducted using a random effects model. Ten publications fulfilled our eligibility criteria, of which four were RCTs and six were cohort studies with controls. There were statistical as well as clinical heterogeneity among included studies. A total of 1034 patients received preoperative IABP and 1329 did not receive preoperative IABP. The pooled odds ratio (OR) for hospital mortality in patients treated with preoperative IABP was 0.41 (95% CI, 0.21-0.82, p = 0.01). The number needed to treat was 17. The pooled OR for hospital mortality from randomized trials was 0.18 (95% CI, 0.06-0.57, p = 0.003) and from cohort studies was 0.54 (95% CI, 0.24-1.2, p = 0.13). Overall, 3.7% (13 of 349) of patients who received preoperative IABP developed either limb ischemia or haematoma at the IABP insertion site, and most of these complications improved after discontinuation of IABP. Evidence from this meta-analysis support the use of preoperative IABP in high-risk patients to reduce hospital mortality.

Effects of librarian-provided services in healthcare settings: a systematic review.

PubMed

Perrier, Laure; Farrell, Ann; Ayala, A Patricia; Lightfoot, David; Kenny, Tim; Aaronson, Ellen; Allee, Nancy; Brigham, Tara; Connor, Elizabeth; Constantinescu, Teodora; Muellenbach, Joanne; Epstein, Helen-Ann Brown; Weiss, Ardis

2014-01-01

To assess the effects of librarian-provided services in healthcare settings on patient, healthcare provider, and researcher outcomes. Medline, CINAHL, ERIC, LISA (Library and Information Science Abstracts), and the Cochrane Central Register of Controlled Trials were searched from inception to June 2013. Studies involving librarian-provided services for patients encountering the healthcare system, healthcare providers, or researchers were eligible for inclusion. All librarian-provided services in healthcare settings were considered as an intervention, including hospitals, primary care settings, or public health clinics. Twenty-five articles fulfilled our eligibility criteria, including 22 primary publications and three companion reports. The majority of studies (15/22 primary publications) examined librarians providing instruction in literature searching to healthcare trainees, and measured literature searching proficiency. Other studies analyzed librarian-provided literature searching services and instruction in question formulation as well as the impact of librarian-provided services on patient length of stay in hospital. No studies were found that investigated librarians providing direct services to researchers or patients in healthcare settings. Librarian-provided services directed to participants in training programs (eg, students, residents) improve skills in searching the literature to facilitate the integration of research evidence into clinical decision-making. Services provided to clinicians were shown to be effective in saving time for health professionals and providing relevant information for decision-making. Two studies indicated patient length of stay was reduced when clinicians requested literature searches related to a patient's case. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (The PATH Study): study protocol for a randomized controlled trial.

PubMed

van Schaik, Ivo N; van Geloven, Nan; Bril, Vera; Hartung, Hans-Peter; Lewis, Richard A; Sobue, Gen; Lawo, John-Philip; Mielke, Orell; Cornblath, David R; Merkies, Ingemar S J

2016-07-25

Subcutaneous administration of Ig (SCIg) has gained popularity as an alternative route of administration but has never been rigorously examined in chronic inflammatory demyelinating polyneuropathy (CIDP). The primary objective of the PATH study (Polyneuropathy and Treatment with Hizentra) is to determine the efficacy of two different doses of SCIg IgPro20 (0.2 g/kg bw or 0.4 g/kg bw) in a 24-week maintenance treatment of CIDP in comparison to placebo. The primary efficacy endpoint will be the proportion of patients who show CIDP relapse (1-point deterioration on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score) or are withdrawn within 24 weeks after randomization for any reason. IVIg-dependent adult patients with definite or probable CIDP according to the European Federation of Neurological Societies/Peripheral Nerve Society who fulfil the inclusion and exclusion criteria will be eligible. Based on sample-size calculation and relapse assumptions in the three arms, a sample size of 58 is needed per arm (overall sample size will be 350, of which 174 will be randomized). All eligible patients will progress through three study periods: an IgG dependency period (≤12 weeks) to select those who are Ig dependent; an IVIg restabilization period (10 or 13 weeks), which will be performed using the 10 % IgPro10 product; and an SC treatment period (24 weeks, followed by a 1-week completion visit after last follow-up). Patients showing IVIg restabilization will be randomized to demonstrate the efficacy of SCIg IgPro20 maintenance treatment over placebo. After completing the study, subjects are eligible to enter a long-term, open-label, extension study of 1 year or return to their previous treatment. In case of CIDP relapse during the 24-week SC treatment period, IgPro10 rescue medication will be offered. Safety, tolerability, and patients' preference of Ig administration route will be examined. The PATH trial, which started in March 2012, is expected to finish at the end of 2016. The results will increase knowledge about the efficacy, safety, and tolerability of SCIg in maintenance management of CIDP patients. ClinicalTrials.gov, NCT01545076 . Registered on 1 March 2012.

Gloves, gowns and masks for reducing the transmission of meticillin-resistant Staphylococcus aureus (MRSA) in the hospital setting.

PubMed

López-Alcalde, Jesús; Mateos-Mazón, Marta; Guevara, Marcela; Conterno, Lucieni O; Solà, Ivan; Cabir Nunes, Sheila; Bonfill Cosp, Xavier

2015-07-16

Meticillin-resistant Staphylococcus aureus (MRSA; also known as methicillin-resistant S aureus) is a common hospital-acquired pathogen that increases morbidity, mortality, and healthcare costs. Its control continues to be an unresolved issue in many hospitals worldwide. The evidence base for the effects of the use of gloves, gowns or masks as control measures for MRSA is unclear. To assess the effectiveness of wearing gloves, a gown or a mask when contact is anticipated with a hospitalised patient colonised or infected with MRSA, or with the patient's immediate environment. We searched the Specialised Registers of three Cochrane Groups (Wounds Group on 5 June 2015; Effective Practice and Organisation of Care (EPOC) Group on 9 July 2013; and Infectious Diseases Group on 5 January 2009); CENTRAL (The Cochrane Library 2015, Issue 6); DARE, HTA, NHS EED, and the Methodology Register (The Cochrane Library 2015, Issue 6); MEDLINE and MEDLINE In-Process & Other Non-Indexed Citations (1946 to June week 1 2015); EMBASE (1974 to 4 June 2015); Web of Science (WOS) Core Collection (from inception to 7 June 2015); CINAHL (1982 to 5 June 2015); British Nursing Index (1985 to 6 July 2010); and ProQuest Dissertations & Theses Database (1639 to 11 June 2015). We also searched three trials registers (on 6 June 2015), references list of articles, and conference proceedings. We finally contacted relevant individuals for additional studies. Studies assessing the effects on MRSA transmission of the use of gloves, gowns or masks by any person in the hospital setting when contact is anticipated with a hospitalised patient colonised or infected with MRSA, or with the patient's immediate environment. We did not assess adverse effects or economic issues associated with these interventions.We considered any comparator to be eligible. With regard to study design, only randomised controlled trials (clustered or not) and the following non-randomised experimental studies were eligible: quasi-randomised controlled trials (clustered or not), non-randomised controlled trials (clustered or not), controlled before-and-after studies, controlled cohort before-after studies, interrupted time series studies (controlled or not), and repeated measures studies. We did not exclude any study on the basis of language or date of publication. Two review authors independently decided on eligibility of the studies. Had any study having been included, two review authors would have extracted data (at least for outcome data) and assessed the risk of bias independently. We would have followed the standard methodological procedures suggested by Cochrane and the Cochrane EPOC Group for assessing risk of bias and analysing the data. We identified no eligible studies for this review, either completed or ongoing. We found no studies assessing the effects of wearing gloves, gowns or masks for contact with MRSA hospitalised patients, or with their immediate environment, on the transmission of MRSA to patients, hospital staff, patients' caregivers or visitors. This absence of evidence should not be interpreted as evidence of no effect for these interventions. The effects of gloves, gowns and masks in these circumstances have yet to be determined by rigorous experimental studies, such as cluster-randomised trials involving multiple wards or hospitals, or interrupted time series studies.

Intolerance to dietary biogenic amines: a review.

PubMed

Jansen, Sophia C; van Dusseldorp, Marijke; Bottema, Kathelijne C; Dubois, Anthony E J

2003-09-01

To evaluate the scientific evidence for purported intolerance to dietary biogenic amines. MEDLINE was searched for articles in the English language published between January 1966 and August 2001. The keyword biogenic amin* was combined with hypersens*, allerg*, intoler*, and adverse. Additionally, the keywords histamine, tyramine, and phenylethylamine were combined with headache, migraine, urticaria, oral challenge, and oral provocation. Articles were also selected from references in relevant literature. Only oral challenge studies in susceptible patients were considered. Studies with positive results (ie, studies in which an effect was reported) were only eligible when a randomized, double-blind, placebo-controlled design was used. Eligible positive result studies were further evaluated according to a number of scientific criteria. Studies with negative results (ie, studies in which no effect was reported) were examined for factors in their design or methods that could be responsible for a false-negative outcome. Results of methodologically weak or flawed studies were considered inconclusive. A total of 13 oral challenge studies (5 with positive results and 8 with negative results) were found. Three of them (all with positive results) were considered ineligible. By further evaluation of the 10 eligible studies, 6 were considered inconclusive. The 4 conclusive studies all reported negative results. One conclusive study showed no relation between biogenic amines in red wine and wine intolerance. Two conclusive studies found no effect of tyramine on migraine. One conclusive study demonstrated no relation between the amount of phenylethylamine in chocolate and headache attacks in individuals with headache. The current scientific literature shows no relation between the oral ingestion of biogenic amines and food intolerance reactions. There is therefore no scientific basis for dietary recommendations concerning biogenic amines in such patients.

Results of NCCTG N0275 (Alliance) - a phase II trial evaluating resection followed by adjuvant radiation therapy for patients with desmoplastic melanoma.

PubMed

Rule, William G; Allred, Jacob B; Pockaj, Barbara A; Markovic, Svetomir N; DiCaudo, David J; Erickson, Lori A; Deming, Richard L; Schild, Steven E

2016-08-01

To examine, in a prospective fashion, the utilization and efficacy of adjuvant radiation therapy (RT) in patients with resected desmoplastic melanoma (DM). Adult patients with resected, margin-negative, and nonmetastatic DM were eligible for this single-arm prospective phase II study. Patients were to receive postoperative RT, 30 Gy in five fractions, to the operative bed with 2- to 3-cm margins (depending on the tumor location). Nodal basin RT was not allowed. The primary study endpoint was the 2-year local recurrence rate (LRR). Secondary endpoints included the incidence of regional and distant metastatic disease, progression-free survival, overall survival (OS), and treatment-related toxicity. Twenty patients with a single de novo DM lesion meeting trial eligibility criteria were enrolled and treated. The 2-year LRR was 10%, with two patients demonstrating a LR within 2 years of completion of protocol therapy. No regional or distant failures occurred. OS at 2 and 5 years was 95 and 77%, respectively. There were no grade 3 or higher acute or late adverse events that were related to the protocol therapy. Adjuvant RT after wide local excision (WLE) for DM is efficacious and well tolerated. It should be considered for DM patients after margin-negative WLE. Additional study is needed to further refine low-risk patient populations that can potentially have adjuvant RT omitted as part of the treatment plan. © 2016 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Why are HIV-infected people not started on antiretroviral therapy? A mixed-methods study from Gujarat, India

PubMed Central

Shringarpure, K.; Modi, B.; Sharma, R.; Rewari, B. B.; Shah, A. N.; Verma, P. B.; Dongre, A. R.; Kumar, A. M. V.

2017-01-01

Setting: Five purposively selected antiretroviral therapy (ART) centres in Gujarat, India. Objectives: To assess the proportion of ART-eligible people living with the human immunodeficiency virus (PLHIV) who were not initiated on ART within 2 months of being recorded as eligible, to identify factors associated with non-initiation and to explore reasons from the provider's perspective. Design: We used a mixed-methods design (triangulation) of 1) a quantitative phase involving record reviews and cohort analysis (Poisson regression) of PLHIV registered during April 2014–March 2015, and 2) a qualitative phase involving one-to-one interviews with 25 providers. Results: Of 2079 ART-eligible PLHIV, 339 (16%) were not started on ART within 2 months. PLHIV with CD4 counts of <350 cells/μl and patients who were labourers, hospitalised, bedridden or registered with certain ART centres were more likely not to be initiated on ART. Qualitative results were categorised into two broad themes: government health system- and patient-related challenges, which validated and complemented the quantitative findings. Conclusion: Several patient subgroups at greater risk of ART non-initiation were identified, along with reasons for risk; this has important programme implications for achieving the UNAIDS 90–90–90 goal, and particularly the second 90 component of having 90% of diagnosed PLHIV start ART. PMID:29201653

The "Interval Walking in Colorectal Cancer" (I-WALK-CRC) study: Design, methods and recruitment results of a randomized controlled feasibility trial.

PubMed

Banck-Petersen, Anna; Olsen, Cecilie K; Djurhuus, Sissal S; Herrstedt, Anita; Thorsen-Streit, Sarah; Ried-Larsen, Mathias; Østerlind, Kell; Osterkamp, Jens; Krarup, Peter-Martin; Vistisen, Kirsten; Mosgaard, Camilla S; Pedersen, Bente K; Højman, Pernille; Christensen, Jesper F

2018-03-01

Low physical activity level is associated with poor prognosis in patients with colorectal cancer (CRC). To increase physical activity, technology-based platforms are emerging and provide intriguing opportunities to prescribe and monitor active lifestyle interventions. The "Interval Walking in Colorectal Cancer"(I-WALK-CRC) study explores the feasibility and efficacy a home-based interval-walking intervention delivered by a smart-phone application in order to improve cardio-metabolic health profile among CRC survivors. The aim of the present report is to describe the design, methods and recruitment results of the I-WALK-CRC study.Methods/Results: The I-WALK-CRC study is a randomized controlled trial designed to evaluate the feasibility and efficacy of a home-based interval walking intervention compared to a waiting-list control group for physiological and patient-reported outcomes. Patients who had completed surgery for local stage disease and patients who had completed surgery and any adjuvant chemotherapy for locally advanced stage disease were eligible for inclusion. Between October 1st , 2015, and February 1st , 2017, 136 inquiries were recorded; 83 patients were eligible for enrollment, and 42 patients accepted participation. Age and employment status were associated with participation, as participants were significantly younger (60.5 vs 70.8 years, P < 0.001) and more likely to be working (OR 5.04; 95%CI 1.96-12.98, P < 0.001) than non-participants. In the present study, recruitment of CRC survivors was feasible but we aim to better the recruitment rate in future studies. Further, the study clearly favored younger participants. The I-WALK-CRC study will provide important information regarding feasibility and efficacy of a home-based walking exercise program in CRC survivors.

Development of a Mobile Tool That Semiautomatically Screens Patients for Stroke Clinical Trials.

PubMed

Spokoyny, Ilana; Lansberg, Maarten; Thiessen, Rosita; Kemp, Stephanie M; Aksoy, Didem; Lee, YongJae; Mlynash, Michael; Hirsch, Karen G

2016-10-01

Despite several national coordinated research networks, enrollment in many cerebrovascular trials remains challenging. An electronic tool was needed that would improve the efficiency and efficacy of screening for multiple simultaneous acute clinical stroke trials by automating the evaluation of inclusion and exclusion criteria, improving screening procedures and streamlining the communication process between the stroke research coordinators and the stroke clinicians. A multidisciplinary group consisting of physicians, study coordinators, and biostatisticians designed and developed an electronic clinical trial screening tool on a HIPAA (Health Insurance Portability and Accountability Act)-compliant platform. A web-based tool was developed that uses branch logic to determine eligibility for simultaneously enrolling clinical trials and automatically notifies the study coordinator teams about eligible patients. After 12 weeks of use, 225 surveys were completed, and 51 patients were enrolled in acute stroke clinical trials. Compared with the 12 weeks before implementation of the tool, there was an increase in enrollment from 16.5% of patients screened to 23.4% of patients screened (P<0.05). Clinicians and coordinators reported increased satisfaction with the process and improved ease of screening. We created a semiautomated electronic screening tool that uses branch logic to screen patients for stroke clinical trials. The tool has improved efficiency and efficacy of screening, and it could be adapted for use at other sites and in other medical fields. © 2016 American Heart Association, Inc.

A Phase II Study of Intensity Modulated Radiation Therapy to the Pelvis for Postoperative Patients With Endometrial Carcinoma: Radiation Therapy Oncology Group Trial 0418

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jhingran, Anuja, E-mail: ajhingra@mdanderson.org; Winter, Kathryn; Portelance, Lorraine

2012-09-01

Purpose: To determine the feasibility of pelvic intensity modulated radiation therapy (IMRT) for patients with endometrial cancer in a multi-institutional setting and to determine whether this treatment is associated with fewer short-term bowel adverse events than standard radiation therapy. Methods: Patients with adenocarcinoma of the endometrium treated with pelvic radiation therapy alone were eligible. Guidelines for target definition and delineation, dose prescription, and dose-volume constraints for the targets and critical normal structures were detailed in the study protocol and a web-based atlas. Results: Fifty-eight patients were accrued by 25 institutions; 43 were eligible for analysis. Forty-two patients (98%) had anmore » acceptable IMRT plan; 1 had an unacceptable variation from the prescribed dose to the nodal planning target volume. The proportions of cases in which doses to critical normal structures exceeded protocol criteria were as follows: bladder, 67%; rectum, 76%; bowel, 17%; and femoral heads, 33%. Twelve patients (28%) developed grade {>=}2 short-term bowel adverse events. Conclusions: Pelvic IMRT for endometrial cancer is feasible across multiple institutions with use of a detailed protocol and centralized quality assurance (QA). For future trials, contouring of vaginal and nodal tissue will need continued monitoring with good QA and better definitions will be needed for organs at risk.« less

Feasibility of a Telehealth Educational Program on Self-Management of Pain and Fatigue in Adult Cancer Patients.

PubMed

Rocque, Gabrielle B; Halilova, Karina I; Varley, Allyson L; Williams, Courtney P; Taylor, Richard A; Masom, David G; Wright, William J; Partridge, Edward E; Kvale, Elizabeth A

2017-06-01

Pain and fatigue are common symptoms among cancer patients and often lead to substantial distress. Innovative self-management programs for pain and fatigue are needed. The primary objective was to assess the feasibility of a telehealth pain and fatigue self-management program among adult cancer patients. Secondary objectives included assessment of differences in patient characteristics, recruitment, and retention of patients based on two screening strategies: 1) navigator-collected, patient-reported pain or fatigue and 2) in-clinic, physician-identified pain or fatigue. This prospective, nonrandomized, pre-post evaluation assessed feasibility, which was defined as 50% of eligible patients choosing to participate and completing the intervention. Patient demographics and patient-reported outcomes (patient activation, distress, symptoms, and quality of life) were collected at baseline and study completion. Differences in baseline characteristics were compared between cohorts and for patients who did vs. did not graduate from the program. The program did not meet feasibility requirements because of only 34% of eligible patients choosing to participate. However, 50% of patients starting the program graduated. Differences in baseline characteristics and retention rates were noted by recruitment strategy. At baseline, 27.3% of navigated patients were at the highest activation level compared with 7.1% in the physician-referred, non-navigated patients (P = 0.17); more than 15% of non-completers were at the lowest activation level compared with 9% of completers (P = 0.85). Telehealth self-management program for pain and fatigue may be better accepted among selected segments of cancer patients. Larger scale studies are needed to assess the efficacy of this program in a more selective activated population. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Vestibular Deficits Following Youth Concussion

PubMed Central

Corwin, Daniel J.; Wiebe, Douglas J.; Zonfrillo, Mark R.; Grady, Matthew F.; Robinson, Roni L.; Goodman, Arlene M.; Master, Christina L.

2015-01-01

Objective To characterize the prevalence and recovery of pediatric patients with concussion who manifest clinical vestibular deficits, and to describe the correlation of these deficits with neurocognitive function, based on computerized neurocognitive testing, in a sample of pediatric patients with concussion. Methods This was a retrospective cohort study of patients age 5–18 years old with concussion referred to a tertiary pediatric hospital-affiliated sports medicine clinic from 7/1/2010–12/31/2011. A random sample of all eligible patient visits was obtained, and all related visits for those patients were reviewed. Results 247 patients were chosen from 3740 eligible visits for detailed review and abstraction. 81% showed a vestibular abnormality on initial clinical exam. Those patients with vestibular signs on initial exam took a significantly longer time to return to school (median 59 days vs. 6 days, p=0.001) or to be fully cleared (median 106 days vs. 29 days, p=0.001). They additionally scored more poorly on initial computerized neurocognitive testing, and took longer for neurocognitive deficits to recover. Those patients with three or more prior concussions had a higher prevalence of vestibular deficits and took longer for those deficits to resolve. Conclusion Vestibular deficits in children and adolescents with a history of concussion are highly prevalent. These deficits appear to be associated with extended recovery times and poorer performance on neurocognitive testing. Further studies evaluating the effectiveness of vestibular therapy on improving such deficits are warranted. PMID:25748568

Feasibility of acute thrombolytic therapy for stroke.

PubMed

Nandigam, K; Narayan, S K; Elangovan, S; Dutta, T K; Sethuraman, K R; Das, A K

2003-12-01

Thrombolysis is an expensive medical intervention for ischemic stroke and hence there is a need to study the feasibility of thrombolysis in rural India. To asses the feasibility and limitations of providing thrombolytic therapy to acute ischemic stroke patients in a rural Indian set-up. The first 64 consecutive patients registered under the Acute Stroke Registry in a university referral hospital with a rural catchment area were studied as per a detailed protocol and questionnaire. Of the 64 patients 44 were ischemic strokes, and 20 were hemorrhagic. Thirteen (29.55%) patients with ischemic stroke reached a center with CT scan facility within 3 hours, of whom only 7 (15.91%) were eligible to receive thrombolytic therapy as per the existing clinical and radiological criteria, but none received the therapy. Of the remaining 31 (70.45%) who arrived late, 11 (25%) had no clinical and radiological contraindications for thrombolysis, except the time factor. All the patients belonged to a low socioeconomic status and a rural background. Though a large proportion of ischemic stroke patients were eligible to receive thrombolytic therapy, the majority could not reach a center with adequate facilities within the recommended time window. More alarmingly, even for those patients who reached within the time window, no significant attempt was made to initiate thrombolysis. These data call not only for attention to improve existing patient transport facilities, but also for improving the awareness of efficacy and therapeutic window of thrombolysis in stroke, among the public as well as primary care doctors.

Outcomes of Cardiopulmonary Resuscitation and Estimation of Healthcare Costs in Potential ‘Do Not Resuscitate’ Cases

PubMed Central

Ahmad, Akhwand S.; Mudasser, Sayed; Khan, Muhammad N.; Abdoun, Hafiz N. H.

2016-01-01

Objectives: Cardiopulmonary resuscitation (CPR) is a life-saving procedure which may fail if applied unselectively. ‘Do not resuscitate’ (DNR) policies can help avoid futile life-saving attempts among terminally-ill patients. This study aimed to assess CPR outcomes and estimate healthcare costs in potential DNR cases. Methods: This retrospective study was carried out between March and June 2014 and included 50 adult cardiac arrest patients who had undergone CPR at Sultan Qaboos Hospital in Salalah, Oman. Medical records were reviewed and treating teams were consulted to determine DNR eligibility. The outcomes, clinical risk categories and associated healthcare costs of the DNR candidates were assessed. Results: Two-thirds of the potential DNR candidates were ≥60 years old. Eight patients (16%) were in a vegetative state, 39 (78%) had an irreversible terminal illness and 43 (86%) had a low likelihood of successful CPR. Most patients (72%) met multiple criteria for DNR eligibility. According to clinical risk categories, these patients had terminal malignancies (30%), recent massive strokes (16%), end-stage organ failure (30%) or were bed-bound (50%). Initial CPR was unsuccessful in 30 patients (60%); the remaining 20 patients (40%) were initially resuscitated but subsequently died, with 70% dying within 24 hours. These patients were ventilated for an average of 5.6 days, with four patients (20%) requiring >15 days of ventilation. The average healthcare cost per patient was USD $1,958.9. Conclusion: With careful assessment, potential DNR patients can be identified and futile CPR efforts avoided. Institutional DNR policies may help to reduce healthcare costs and improve services. PMID:26909209

Restrictive vs liberal blood transfusion for acute upper gastrointestinal bleeding: rationale and protocol for a cluster randomized feasibility trial.

PubMed

Jairath, Vipul; Kahan, Brennan C; Gray, Alasdair; Doré, Caroline J; Mora, Ana; Dyer, Claire; Stokes, Elizabeth A; Llewelyn, Charlotte; Bailey, Adam A; Dallal, Helen; Everett, Simon M; James, Martin W; Stanley, Adrian J; Church, Nicholas; Darwent, Melanie; Greenaway, John; Le Jeune, Ivan; Reckless, Ian; Campbell, Helen E; Meredith, Sarah; Palmer, Kelvin R; Logan, Richard F A; Travis, Simon P L; Walsh, Timothy S; Murphy, Michael F

2013-07-01

Acute upper gastrointestinal bleeding (AUGIB) is the commonest reason for hospitalization with hemorrhage in the UK and the leading indication for transfusion of red blood cells (RBCs). Observational studies suggest an association between more liberal RBC transfusion and adverse patient outcomes, and a recent randomised trial reported increased further bleeding and mortality with a liberal transfusion policy. TRIGGER (Transfusion in Gastrointestinal Bleeding) is a pragmatic, cluster randomized trial which aims to evaluate the feasibility and safety of implementing a restrictive versus liberal RBC transfusion policy in adult patients admitted with AUGIB. The trial will take place in 6 UK hospitals, and each centre will be randomly allocated to a transfusion policy. Clinicians throughout each hospital will manage all eligible patients according to the transfusion policy for the 6-month trial recruitment period. In the restrictive centers, patients become eligible for RBC transfusion when their hemoglobin is <8 g/dL. In the liberal centers patients become eligible for transfusion once their hemoglobin is <10 g/dL. All clinicians will have the discretion to transfuse outside of the policy but will be asked to document the reasons for doing so. Feasibility outcome measures include protocol adherence, recruitment rate, and evidence of selection bias. Clinical outcome measures include further bleeding, mortality, thromboembolic events, and infections. Quality of life will be measured using the EuroQol EQ-5D at day 28, and the costs associated with hospitalization for AUGIB in the UK will be estimated. Consent will be sought from participants or their representatives according to patient capacity for use of routine hospital data and day 28 follow up. The study has ethical approval for conduct in England and Scotland. Results will be analysed according to a pre-defined statistical analysis plan and disseminated in peer reviewed publications to relevant stakeholders. The results of this study will inform the feasibility and design of a phase III randomized trial. Copyright © 2013 Elsevier Inc. All rights reserved.

Effectiveness of emergency nurses' use of the Ottawa Ankle Rules to initiate radiographic tests on improving healthcare outcomes for patients with ankle injuries: A systematic review.

PubMed

Ho, Jonathan Ka-Ming; Chau, Janita Pak-Chun; Cheung, Nancy Man-Ching

2016-11-01

The Ottawa Ankle Rules provide guidelines for clinicians on the recommendation of radiographic tests to verify fractures in patients with ankle injuries. The use of the Ottawa Ankle Rules by emergency nurses has been suggested to minimise unnecessary radiographic-test requests and reduce patients' length of stay in emergency departments. However, the findings of studies in this area are inconsistent. A systematic review was conducted to synthesise the most accurate evidence available on the extent to which emergency nurses' use of the Ottawa Ankle Rules to initiate radiographic tests improves healthcare outcomes for patients with ankle injuries. The systematic review attempted to identify all relevant published and unpublished studies in English and Chinese from databases such as Ovid MEDLINE, EMBASE, ProQuest Health and Medical Complete, EBM Reviews, SPORTDiscus, CINAHL Plus, the British Nursing Index, Scopus, the Chinese Biomedical Literature Database, China Journal Net, WanFang Data, the National Central Library Periodical Literature System, HyRead, the Digital Dissertation Consortium, MedNar and Google Scholar. Two reviewers independently assessed the eligibility of all of the studies identified during the search, based on their titles and abstracts. If a study met the criteria for inclusion, or inconclusive information was available in its title and abstract, the full text was retrieved for further analysis. The methodological quality of all of the eligible studies was assessed independently by the two reviewers. The search of databases and other sources yielded 1603 records. The eligibility of 17 full-text articles was assessed, and nine studies met the inclusion criteria. All nine studies were subjected to narrative analysis, and five were meta-analysed. All of the studies investigated the use of the refined Ottawa Ankle Rules. The results indicated that emergency nurses' use of the refined Ottawa Ankle Rules minimised unnecessary radiographic-test requests and reduced patients' length of stay in emergency departments. However, the use of these rules in urgent-care departments did not reduce unnecessary radiographic-test requests or patients' length of stay. The implementation of the refined Ottawa Ankle Rules by emergency nurses with different backgrounds, including nurse practitioners or general emergency nurses was found to reduce patients' length of stay in emergency departments. The results of the systematic review suggested that a nurse-initiated radiographic test protocol should be introduced as standard practice in emergency departments. Copyright © 2016 Elsevier Ltd. All rights reserved.

Safety Experience During Real-World Use of Injectable Artesunate in Public Health Facilities in Ghana and Uganda: Outcomes of a Modified Cohort Event Monitoring Study (CEMISA).

PubMed

Ampadu, H Hilda; Dodoo, Alexander N O; Bosomprah, Samuel; Akakpo, Samantha; Hugo, Pierre; Gardarsdottir, Helga; Leufkens, H G M; Kajungu, Dan; Asante, Kwaku Poku

2018-04-25

Injectable artesunate (Inj AS) is the World Health Organization (WHO)-recommended product for treating severe malaria. However, despite widespread usage, there are few published safety studies involving large populations in real-world settings. In this study, we sought to assess the incidence of common adverse events (AEs) following the intake of Inj AS in real-life settings. This is a modified cohort event monitoring study involving patients who were administered with Inj AS at eight sites (four each in Ghana and Uganda) between May and December 2016. Patients were eligible for inclusion if they had severe/complicated malaria and were able and willing to participate in the study. Eligible patients were followed up by telephone or hospital or home visit on Days 7, 14, 21 and 28 after drug administration to document AEs and serious AEs (SAEs). Patients were also encouraged to report all AEs at any time during the study period. The Kaplan-Meier method was used to estimate the proportion of patients with any AEs by end of Day 28. Causality assessment was made on all AEs/SAEs using the WHO/UMC (Uppsala Monitoring Centre) causality method. A total of 1103 eligible patients were administered Inj AS, of which 360 patients were in Ghana and 743 in Uganda. The incidence of any AE by the end of follow-up among patients treated with AS was estimated to be 17.9% (197/1103) (95% confidence interval [CI] 15.8-20.3). The median time-to-onset of any AEs was 9 days (interquartile range (IQR) = 4, 14). The top five AEs recorded among patients treated with AS were pyrexia (3.5%), abdominal pain (2.5%), diarrhoea (1.7%), cough (1.5%) and asthenia (1.5%). Most of these top five AEs occurred in the first 14 days following treatment. Regarding the relatedness of these AEs to Inj AS, 78.9% of pyrexia (30/38), 63.0% of pain (17/27), 68.4% of diarrhoea (13/19), 85.5% of cough (14/16) and 75.0% of asthenia (12/16) were assessed as 'possibly' related. There were 17 SAEs including 13 deaths. Two of the deaths are 'possibly' related to Inj AS, as were three non-fatal SAEs: severe abdominal pain, failure of therapy and severe anaemia. The incidence of common AEs among patients treated with Inj AS in real-world settings was found to be relatively low. Future studies should consider larger cohorts to document rare AEs as well. CLINICALTRIALS. NCT02817919.

Impact of the Adalimumab Patient Support Program on Clinical Outcomes in Ankylosing Spondylitis: Results from the COMPANION Study.

PubMed

Bessette, Louis; Lebovic, Gerald; Millson, Brad; Charland, Katia; Donepudi, Krishna; Gaetano, Tania; Remple, Valencia; Latour, Martin G; Gazel, Sandra; Laliberté, Marie-Claude; Thorne, Carter

2018-06-01

Adalimumab (ADA) is a tumor necrosis factor (TNF)-alpha inhibitor indicated for the treatment of inflammatory autoimmune diseases, including ankylosing spondylitis (AS). Patients receiving ADA in Canada are eligible to enroll in the AbbVie Care™ patient support program (AC-PSP), which provides personalized services, including care coach calls (CCCs). We estimated the likelihood of controlled disease in a cohort of AS patients treated with ADA enrolled in the AC-PSP and who received CCCs versus those who did not. A longitudinal analysis using de-identified aggregate-level data collected through the AC-PSP was performed. A probabilistic matching algorithm was used to link patient-level records from the AC-PSP database to records from the QuintilesIMS longitudinal prescription transactions database. Patients were indexed on the date of their first prescription of ADA between January 2010 and October 2015. The AC-PSP database included patient assessments of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), a measure of disease activity. Eligible patients had a baseline BASDAI assessment performed between 90 days before and 30 days after the index date, and a follow-up BASDAI assessment 6-18 months later. Poisson regression was used to estimate the adjusted relative risk (RR) of controlled disease (BASDAI < 4) at the time of follow-up, comparing patients who received CCCs with those who did not. In total 249 AS patients met eligibility criteria, and 123 (49%) received CCCs. Of the 249 patients, 184 (74%) had controlled disease (BASDAI < 4) at follow-up assessment, 98 (80%) in the CCC group and 86 (68%) in the no CCC group. Multivariable regression analysis demonstrated a 23% increased likelihood of controlled disease in patients who received CCCs relative to those who did not (RR = 1.23; 95% confidence interval, 1.06-1.42; p = 0.0055). AS patients receiving tailored services through the AC-PSP in the form of CCCs have an increased likelihood of controlled disease within 6-18 months. AbbVie.

Low circulating ghrelin levels in women with polycystic ovary syndrome: a systematic review and meta-analysis

PubMed Central

Gao, Tian; Wu, Lang; Chang, Fuhou; Cao, Guifang

2016-01-01

Although numerous, human subject studies evaluating the relationship between circulating ghrelin levels and polycystic ovary syndrome (PCOS) risk have yielded inconsistent findings. We aimed to quantitatively assess the association by summarizing all available evidence from human subject studies. The PubMed and Web of Science databases were searched up to February 2015 for eligible studies. Studies were eligible if they reported circulating ghrelin levels in women with PCOS and healthy women controls. A fixed or random-effects model was used to pool risk estimations. Twenty studies including 894 PCOS patients and 574 controls were included in the meta-analysis. The studies had fair methodological quality. The pooling analysis of all available studies revealed that ghrelin levels were significantly lower in PCOS patients than in controls, with standardized mean difference of −0.40 (95% CI: −0.73, −0.08). The significant association persisted in many subgroup strata. However, the heterogeneity across studies was considerable and not eliminated in subgroup analyses. Meta-regression analysis further suggested that the heterogeneity might be relevant to variability in study location, PCOS relevant factors like HOMA-IR ratio, as well as other factors not assessed. In conclusion, our meta-analysis suggested that ghrelin levels were significantly lower in PCOS patients than in controls. Further studies with large sample sizes are warranted to replicate our findings. PMID:26607017

International Normalized Ratio values in group versus individual appointments in a pharmacist-managed anticoagulation clinic.

PubMed

Griffin, Brooke L; Burkiewicz, Jill S; Peppers, Laura R; Warholak, Terri L

2009-07-01

The clinical effectiveness of a group-visit model versus individual point-of-care visits is compared by International Normalized Ratio (INR) monitoring in a pharmacist-managed anticoagulation clinic. This study was a prospective, randomized, repeated-measures, two-group, intention-to-treat comparison and survey at a pharmacist-managed anticoagulation clinic in a managed-care ambulatory care setting. Patients were eligible for this study if they were taking warfarin therapy for at least 30 days, had a goal INR range, and provided consent. At a routine point-of-care visit, eligible patients were randomly invited to participate in group visits. The number of visits and INR values were documented prospectively for both groups during the 16-week study period. Of the 45 patients who consented and enrolled in group visits, 28 patients participated for the 16-week study period. The control group included 108 patients seen by a pharmacist for individual anticoagulation appointments. No significant difference in the percentage of INR values within the therapeutic range was detected between patients in the group-visit model versus patients receiving individual visits (59% versus 56.6%, respectively; p = 0.536). Seventy-three percent of INR values for patients who attended group visits were within +/- 0.2 of the desired INR range compared with 71.9% of those in the control group ( p = 0.994). In addition, 79% of group-visit patients were within the therapeutic range at their last clinic visit compared with 67% of patients who attended individual appointments (p = 0.225). Group visits were preferred by 51% (n = 38) of patients who completed the satisfaction survey. Of the 92 patients who declined group-visit participation, 36% indicated that the time of day that group visits were offered was inconvenient. There were no thromboembolic or hemorrhagic events documented in either group during the study period. Group visits in a pharmacist-managed anticoagulation clinic may provide a safe and effective alternative to individual appointments.

Coordination of palliative cancer care in the community: "unfinished business".

PubMed

Brazil, Kevin; Bainbridge, Daryl; Sussman, Jonathan; Whelan, Tim; O'Brien, Mary Ann; Pyette, Nancy

2009-07-01

This study assessed the degree to which services in south-central Ontario, Canada, were coordinated to meet the supportive care needs of palliative cancer patients and their families. Programs within the region that were identified as providing supportive care to palliative cancer patients and their families were eligible to participate in the study. Program administrators participated in a semi-structured interview and direct-care providers completed a survey instrument. Administrators from 37 (97%) of 38 eligible programs and 109 direct-care providers representing 26 (70%) programs participated in the study. Most administrator and direct-care respondents felt that existing services in the community were responsive to palliative care patients' individual needs. However, at a system level, most respondents in both groups felt that required services were not available and that resources were inadequate. The most frequently reported unmet supportive care need identified by both respondent groups was psychological/social support. Most administrator (69%) and direct-care (64%) respondents felt that palliative care services were not available when needed. The majority of administrator and direct-care respondents were satisfied with the exchange of patient information within and between programs, although direct-care staff identified a deficit in information transferred on palliative care patients' social/psychological status. The study demonstrated the value of a theory-based approach to evaluate the coordination of palliative cancer care services. The findings revealed that service programs faced significant challenges in their efforts to provide coordinated care.

Effectiveness of granisetron in controlling pediatric gastroenteritis-related vomiting after discharge from the ED.

PubMed

Qazi, Khajista; BinSalleeh, Hashim M; Shah, Ubaid H; AlGhamedi, Najwa; Tamim, Hani; Mubasher, Mohamed; Alrasheed, Faris; Alkanhal, Abdulrahman; AlTamimi, Saleh A

2014-09-01

The objective of the study is to determine the efficacy of oral granisetron (a long-acting 5-HT3 receptor antagonist) in stopping vomiting subsequent to discharge from emergency department (ED), in 6-month-old to 8-year-old patients with gastroenteritis-related vomiting and dehydration, who had failed an initial trial of oral rehydration (ORT). Eligible patients were offered ORT on a slowly advancing schedule. Patients who tolerated the initial ORT were discharged home. Patients who vomited were randomized to receive either 40 μg/kg of granisetron or placebo, and ORT was resumed. Patients who tolerated the postrandomization ORT were discharged home with another dose of the study drug. Parents were contacted by telephone every 24 hours until complete resolution of symptoms. The primary outcome was the proportion of patients with vomiting at 24 hours. Of the 900 eligible patients, 537 (60%) tolerated the initial ORT and were discharged home. Of the patients who vomited during the initial ORT, 165 were included in the final study sample (placebo, n = 82; granisetron, n = 83). There was no statistically significant difference in the proportion of patients with vomiting at 24 hours (granisetron, n = 38; placebo, n = 45; odds ratio, 0.64; 95% confidence interval, 0.34-1.19; P = .16). A similar trend in the proportion of patients with vomiting was noted for the entire follow-up period (granisetron, n = 43; placebo, n = 47; odds ratio, 0.73; P = .33; 95% confidence interval, 0.39-1.36). Granisetron was not effective in controlling gastroenteritis-related vomiting subsequent to discharge from ED. It did not change the expected course of the illness. Copyright © 2014 Elsevier Inc. All rights reserved.

Report of a Multicenter Phase II Trial Testing a Combination of Biweekly Bevacizumab and Daily Erlotinib in Patients With Unresectable Biliary Cancer: A Phase II Consortium Study

PubMed Central

Lubner, Sam J.; Mahoney, Michelle R.; Kolesar, Jill L.; LoConte, Noelle K.; Kim, George P.; Pitot, Henry C.; Philip, Philip A.; Picus, Joel; Yong, Wei-Peng; Horvath, Lisa; Van Hazel, Guy; Erlichman, Charles E.; Holen, Kyle D.

2010-01-01

Purpose Biliary cancers overexpress epidermal growth factor receptor (EGFR), and angiogenesis has been correlated with poor outcome. Erlotinib, an EGFR tyrosine kinase inhibitor, and bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor have each been shown to have activity in biliary cancer. The primary objective of this study was to evaluate the response rate by Response Evaluation Criteria in Solid Tumors (RECIST). Secondary end points included overall survival (OS), time to progression (TTP), VEGF levels, and molecular studies of EGFR and k-ras. Patients and Methods Eligible patients had advanced cholangiocarcinoma or gallbladder cancer. Patients were treated with bevacizumab 5 mg/kg intravenously on days 1 and 15 and erlotinib 150 mg by mouth daily on days 1 through 28. Responses were evaluated by RECIST. VEGF levels were collected, and samples were analyzed for EGFR mutation by polymerase chain reaction. Results Fifty-three eligible patients were enrolled at eight sites. Of 49 evaluable patients, six (12%; 95% CI, 6% to 27%) had a confirmed partial response. Stable disease was documented in another 25 patients (51%). Rash was the most common grade 3 toxicity. Four patients had grade 4 toxicities. Median OS was 9.9 months, and TTP was 4.4 months. Low repeats (< 16) in EGFR intron 1 polymorphism and G>G k-ras Q38 genotype (wild type) were associated with improved outcomes. Conclusion Combination chemotherapy with bevacizumab and erlotinib showed clinical activity with infrequent grade 3 and 4 adverse effects in patients with advanced biliary cancers. On the basis of preliminary molecular analysis, presence of a k-ras mutation may alter erlotinib efficacy. The combination of bevacizumab and erlotinib may be a therapeutic alternative in patients with advanced biliary cancer. PMID:20530271

Heterogeneity in Unclassifiable Interstitial Lung Disease: A Systematic Review and Meta-Analysis.

PubMed

Guler, Sabina A; Ellison, Kina; Algamdi, Mohmmed; Collard, Harold R; Ryerson, Christopher J

2018-05-20

Accurate diagnosis of interstitial lung disease (ILD) is necessary to identify the most appropriate management strategy and to inform prognosis. Many patients cannot be provided a confident diagnosis despite an exhaustive search for potential etiologies and review in a multidisciplinary conference; and are consequently labelled with unclassifiable ILD. to systematically review and meta-analyse previous studies reporting on the diagnostic criteria, prevalence, clinical features, and outcome of unclassifiable ILD. Medline, Embase, and the Cochrane Central Register of Controlled Trials databases were systematically searched for all studies related to unclassifiable ILD published before September 1, 2017. Two authors independently screened each citation for eligibility criteria, serially reviewing the title, abstract, and full-text manuscript, and then abstracted data pertaining to the study objectives from eligible studies. Articles were stratified by risk of selection bias, whether the publication stated that patients were reviewed in a multidisciplinary discussion, and by the frequency of surgical lung biopsy. Meta-analyses and meta-regression were performed to calculate the pooled prevalence of unclassifiable ILD within an ILD population and within specific subgroups to identify reasons for across-study heterogeneity. The search identified 10130 unique citations, 313 articles underwent full-text review, and eligibility criteria were met in 88 articles. Twenty-two studies were deemed low risk of selection bias, including 1060 patients with unclassifiable ILD from a total of 10174 patients with ILD. The terminology and definition of unclassifiable ILD varied substantially across publications, with inconsistent diagnostic criteria and evaluation processes. The prevalence of unclassifiable ILD was 11.9% (95% confidence interval 8.5% to 15.6%), with lower prevalence in centers that reported use of a formal multidisciplinary discussion of cases (9.5% vs. 14.5%). Four articles reported survival of unclassifiable ILD, with 1-year, 2-year, and 5-year survival of 84-89%, 70-76%, and 46-70%, respectively. This systematic review and meta-analysis shows that unclassifiable ILD is common but has substantial heterogeneity and inconsistent definitions across ILD cohorts. These findings highlight important limitations in multicentre studies of fibrotic ILD and the need for a standardized approach to ILD diagnostic classification.

A phase II study of combination chemotherapy with docetaxel and carboplatin for patients with advanced or metastatic non-small cell lung cancer.

PubMed

Kasahara, Kazuo; Kimura, Hideharu; Shibata, Kazuhiko; Araya, Tomoyuki; Sone, Takashi; Oribe, Yoshitaka; Furusho, Shiho; Kita, Toshiyuki; Shirasaki, Hiroki; Oribe, Yoshitaka; Yoshimi, Yuzo; Ueda, Akihito; Tachibana, Hideki; Shintani, Hiromoto; Mizuguchi, Masayuki; Nishi, Kohichi; Fujimura, Masaki; Nakao, Shinji

2006-01-01

The aim of this phase II study was to evaluate the efficacy of combination chemotherapy consisting of docetaxel and carboplatin in patients with inoperable non-small cell lung cancer (NSCLC). For this multicenter phase II study, the eligibility criteria included histologically or cytologically proven inoperable NSCLC, measurable lesions, Eastern Cooperative Oncology Group performance status (PS) 0-2, adequate organ and bone marrow functions, and written informed consent. Patients received 60 mg/m2 of docetaxel and carboplatin (target AUC 5.5) on day 1 every 3 weeks until disease progression. The primary end-point of this study was response rate and the secondary end-points were toxicities, time to progression and overall survival. A total of 40 patients were enrolled and 39 patients were eligible. A complete response and partial response were observed in 1 and 13 patients, respectively. An objective response rate was 35.9% (95% confidential interval [CI] 20.8-51.0%). The median time to progression was 5.2 months and the median overall survival was 12.0 months. The 1- and 2-year survival rates were 53.8% and 25.1%, respectively. The major toxicities were leukocytopenia and neutropenia. Grade 3 or 4 thrombocytopenia was rare and non-hematological toxicities were generally mild. Grade 3 non-hematological toxicities were observed in 6 patients (2 with nausea and vomiting, 1 with diarrhea, 1 with elevated transaminase levels, 1 with allergic reaction and 1 with edema). No grade 4 non-hematological toxicities were observed. Docetaxel and carboplatin combination chemotherapy was well tolerated and active in Japanese patients with advanced or metastatic NSCLC.

An overlooked complication of the inguinal hernia repair: Dysejaculation

PubMed Central

Yılmaz, Hüseyin

2018-01-01

The objective of this study was to investigate the rate of post-herniorrhaphy dysejaculation in the current literature. A comprehensive search of PubMed, Medline, Google Scholar, and Google databases was performed using the keywords “groin hernia and chronic pain,” “inguinal hernia and chronic pain,” “dysejaculation,” and “ejaculatory pain.” The eligible studies were evaluated in terms of ejaculatory pain and surgical technique used. Ten studies with 122 patients were eligible for the analysis. The rate of ejaculatory pain for a total of 5521 patients was found to be 2.2%. The incidence of postoperative ejaculatory pain was found to be 2.1% following laparoscopic techniques and 1.1 % following open repair. Open techniques were not related to the increased frequency of dysejaculation. Sufficient data could not be obtained from the studies for the ejaculatory pain, and thus, no statistical evaluation was performed. Dysejaculation is a common cause of postoperative morbidity after inguinal hernia repair. Attention to technical details of the primary operation may reduce the incidence of dysejaculation. PMID:29756096

Clinical trials in "emerging markets": regulatory considerations and other factors.

PubMed

Singh, Romi; Wang, Ouhong

2013-11-01

Clinical studies are being placed in emerging markets as part of global drug development programs to access large pool of eligible patients and to benefit from a cost effective structure. However, over the last few years, the definition of "emerging markets" is being revisited, especially from a regulatory perspective. For purposes of this article, countries outside US, EU and the traditional "western countries" are discussed. Multiple factors are considered for placement of clinical studies such as adherence to Good Clinical Practice (GCP), medical infrastructure & standard of care, number of eligible patients, etc. This article also discusses other quantitative factors such as country's GDP, patent applications, healthcare expenditure, healthcare infrastructure, corruption, innovation, etc. These different factors and indexes are correlated to the number of clinical studies ongoing in the "emerging markets". R&D, healthcare expenditure, technology infrastructure, transparency, and level of innovation, show a significant correlation with the number of clinical trials being conducted in these countries. This is the first analysis of its kind to evaluate and correlate the various other factors to the number of clinical studies in a country. © 2013.

Lung Cancer Screening With Low-Dose CT: Implementation Amid Changing Public Policy at One Health Care System.

PubMed

Begnaud, Abbie; Hall, Thomas; Allen, Tadashi

2016-01-01

Screening for lung cancer with low-dose CT has evolved rapidly in recent years since the National Lung Screening Trial (NLST) results. Subsequent professional and governmental organization guidelines have shaped policy and reimbursement for the service. Increasingly available guidance describes eligible patients and components necessary for a high-quality lung cancer screening program; however, practical instruction and implementation experience is not widely reported. We launched a lung cancer screening program in the face of reimbursement and guideline uncertainties at a large academic health center. We report our experience with implementation, including challenges and proposed solutions. Initially, we saw less referrals than expected for screening, and many patients referred for screening did not clearly meet eligibility guidelines. We educated primary care providers and implemented system tools to encourage referral of eligible patients. Moreover, in response to the Centers for Medicare & Medicaid Services (CMS) final coverage determination, we report our programmatic adaptation to meet these requirements. In addition to the components common to all quality programs, individual health delivery systems will face unique barriers related to patient population, available resources, and referral patterns.

Just-in-Time Evidence-Based E-mail “Reminders” in Home Health Care: Impact on Nurse Practices

PubMed Central

Murtaugh, Christopher M; Pezzin, Liliana E; McDonald, Margaret V; Feldman, Penny H; Peng, Timothy R

2005-01-01

Objective To test the effectiveness of two interventions designed to improve the adoption of evidence-based practices by home health nurses caring for heart failure (HF) patients. Data Sources/Study Setting Information on nurse practices was abstracted from the clinical records of patients admitted between June 2000 and November 2001 to the care of 354 study nurses at a large, urban, nonprofit home care agency. Study Design The study employed a randomized design with nurses assigned to usual care or one of two intervention groups upon identification of an eligible patient. The basic intervention was a one-time e-mail reminder highlighting six HF-specific clinical recommendations. The augmented intervention consisted of the initial e-mail reminder supplemented by provider prompts, patient education material, and clinical nurse specialist outreach. Data Collection At each home health visit provided by a study nurse to an eligible HF patient during the 45-day follow-up period, a structured chart abstraction tool was used to collect information on whether the nurse provided the care practices highlighted in the e-mail reminder. Principal Findings Both the basic and the augmented interventions greatly increased the practice of evidence-based care, according to patient records, in the areas of patient assessment and instructions about HF disease management. While not all results were statistically significant at conventional levels, intervention effects were positive in virtually all cases and effect magnitudes frequently were large. Conclusions The results of this randomized trial strongly support the efficacy of just-in-time evidence-based reminders as a means of changing clinical practice among home health nurses who are geographically dispersed and spend much of their time in the field. PMID:15960694

Pilot non dialysis chronic renal insufficiency study (P-ND-CRIS): a pilot study of an open prospective hospital-based French cohort.

PubMed

Massol, Jacques; Janin, Gérard; Bachot, Camille; Gousset, Christophe; Deville, Geoffroy Sainte-Claire; Chalopin, Jean-Marc

2017-02-01

Before establishing a prospective cohort, an initial pilot study is recommended. However, there are no precise guidelines on this subject. This paper reports the findings of a French regional pilot study carried out in three nephrology departments, before realizing a major prospective Non Dialysis Chronic Renal Insufficiency study (ND-CRIS). We carried out an internal pilot study. The objectives of this pilot study were to validate the feasibility (regulatory approval, providing patients with information, availability of variables, refusal rate of eligible patients) and quality criteria (missing data, rate of patients lost to follow-up, characteristics of the patients included and non-included eligible patients, quality control of the data gathered) and estimate the human resources necessary (number of clinical research associates required). The authorizations obtained (CCTIRS - CNIL) and the contracts signed with hospitals have fulfilled the regulatory requirements. After validating the information on the study provided to patients, 1849 of them were included in three centres (university hospital, intercommunal hospital, town hospital) between April 2012 and September 2015. The low refusal rate (51 patients) and the characteristics of non-included patients have confirmed the benefit for patients of participating in the study and provide evidence of the feasibility and representativeness of the population studied. The lack of missing data on the variables studied, the quality of the data analyzed and the low number of patients lost to follow-up are evidence of the quality of the study. By taking into account the time spent by CRAs to enter data and to travel, as well as the annual patient numbers in each hospital, we estimate that five CRAs will be required in total. With no specific guidelines on how to realize a pilot study before implementing a major prospective cohort, we considered it pertinent to report our experience of P-ND-CRIS. This experience confirms that i) feasibility, ii) quality of data and iii) evaluating the resources required must be validated before carrying out a large prospective cohort study such as ND-CRIS.

Safety and efficacy of BAY 94-9027, a prolonged-half-life factor VIII.

PubMed

Reding, M T; Ng, H J; Poulsen, L H; Eyster, M E; Pabinger, I; Shin, H-J; Walsch, R; Lederman, M; Wang, M; Hardtke, M; Michaels, L A

2017-03-01

Essentials Recombinant factor VIII BAY 94-9027 conjugates in a site-specific manner with polyethylene glycol. BAY 94-9027 was given to patients with severe hemophilia A as prophylaxis and to treat bleeds. BAY 94-9027 prevented bleeds at dose intervals up to every 7 days and effectively treated bleeds. BAY 94-9027 treatment was mainly well tolerated and no patient developed factor VIII inhibitors. Click to hear Dr Tiede's perspective on half-life extended factor VIII for the treatment of hemophilia A SUMMARY: Background BAY 94-9027 is a B-domain-deleted prolonged-half-life recombinant factor VIII (FVIII) that conjugates in a site-specific manner with polyethylene glycol. Objective Assess efficacy and safety of BAY 94-9027 for prophylaxis and treatment of bleeds in patients with severe hemophilia A. Patients/methods In this multinational, phase 2/3, partially randomized, open-label trial, men aged 12-65 years with FVIII < 1% and ≥ 150 exposure days to FVIII received BAY 94-9027 for 36 weeks on demand or prophylactically at intervals determined following a 10-week run-in period on 25 IU kg -1 body weight two times per week. Patients with > 1 bleed during the run-in subsequently received 30-40 IU kg -1 two times per week; patients with ≤ 1 bleed were eligible for randomization to every-5-days (45-60 IU kg -1 ) or every-7-days (60 IU kg -1 ) prophylaxis (1 : 1) for 26 additional weeks until randomization arms were filled. Patients who were eligible but not randomized continued twice-weekly prophylaxis. The primary efficacy outcome was annualized bleeding rate (ABR). Results The intent-to-treat population included 132 patients (prophylaxis, n = 112; on demand, n = 20). Median ABR (quartile [Q1; Q3]) for patients treated two times per week who were not eligible for randomization (n = 13) improved after dose increase (17.4 [14.3; 26.0] to 4.1 [2.0; 10.6]). Median ABR for patients randomized to every-5-days treatment (n = 43) was 1.9 (0; 4.2), similar to patients eligible for randomization but who continued treatment two times per week (n = 11). Median ABR for 32/43 patients (74%) who continued every-7-days prophylaxis until study end was 0.96 (0.0; 4.3). Six hundred and thirty-six of 702 bleeds (90.6%) were controlled with ≤ 2 infusions. No patient developed a FVIII inhibitor. Conclusions BAY 94-9027 prevented bleeding across three individually tailored dose regimens and was effective for treatment of bleeds. © 2016 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals, Inc. on behalf of International Society on Thrombosis and Haemostasis.

Comparative Effectiveness of Phosphate Binders in Patients with Chronic Kidney Disease: A Systematic Review and Network Meta-Analysis.

PubMed

Sekercioglu, Nigar; Thabane, Lehana; Díaz Martínez, Juan Pablo; Nesrallah, Gihad; Longo, Christopher J; Busse, Jason W; Akhtar-Danesh, Noori; Agarwal, Arnav; Al-Khalifah, Reem; Iorio, Alfonso; Guyatt, Gordon H

2016-01-01

Chronic kidney disease-mineral and bone disorder (CKD-MBD) has been linked to poor health outcomes, including diminished quality and length of life. This condition is characterized by high phosphate levels and requires phosphate-lowering agents-phosphate binders. The objective of this systematic review is to compare the effects of available phosphate binders on patient-important outcomes in patients with CKD-MBD. Data sources included MEDLINE and EMBASE Trials from 1996 to February 2016. We also searched the Cochrane Register of Controlled Trials up to April 2016. Teams of two reviewers, independently and in duplicate, screened titles and abstracts and potentially eligible full text reports to determine eligibility, and subsequently abstracted data and assessed risk of bias in eligible randomized controlled trials (RCTs). Eligible trials enrolled patients with CKD-MBD, randomized them to receive calcium (delivered as calcium acetate, calcium citrate or calcium carbonate), non-calcium-based phosphate binders (NCBPB) (sevelamer hydrochloride, sevelamer carbonate, lanthanum carbonate, sucroferric oxyhydroxide and ferric citrate), phosphorus restricted diet, placebo or no treatment, and reported effects on all-cause mortality, cardiovascular mortality or hospitalization at ≥4 weeks follow-up. We performed network meta-analyses (NMA) for all cause-mortality for individual agents (seven-node analysis) and conventional meta-analysis of calcium vs. NCBPBs for all-cause mortality, cardiovascular mortality and hospitalization. In the NMAs, we calculated the effect estimates for direct, indirect and network meta-analysis estimates; for both NMA and conventional meta-analysis, we pooled treatment effects as risk ratios (RR) and calculated 95% confidence intervals (CIs) using random effect models. We used the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to rate the quality of evidence for each paired comparison. Our search yielded 1190 citations, of which 71 RCTs were retrieved for full review and 15 proved eligible. With 13 eligible studies from a prior review, we included 28 studies with 8335 participants; 25 trials provided data for our quantitative synthesis. Results suggest higher mortality with calcium than either sevelamer (NMA RR, 1.89 [95% CI, 1.02 to 3.50], moderate quality evidence) or NCBPBs (conventional meta-analysis RR, 1.76 [95% CI, 1.21 to 2.56, moderate quality evidence). Conventional meta-analysis suggested no difference in cardiovascular mortality between calcium and NCBPBs (RR, 2.54 [95% CI, 0.67 to 9.62 low quality evidence). Our results suggest higher hospitalization, although non-significant, with calcium than NCBPBs (RR, 1.293 [95% CI, 0.94 to 1.74, moderate quality evidence). Use of calcium results in higher mortality than either sevelamer in particular and NCBPBs in general (moderate quality evidence). Our results raise questions about whether administration of calcium as an intervention for CKD- MBD remains ethical. Further research is needed to explore the effects of different types of phosphate binders, including novel agents such as iron, on quality and quantity of life. PROSPERO CRD-42016032945.

Costs of revascularization over eight years in the randomized and eligible patients in the Emory Angioplasty versus Surgery Trial (EAST).

PubMed

Weintraub, W S; Becker, E R; Mauldin, P D; Culler, S; Kosinski, A S; King, S B

2000-10-01

The Emory Angioplasty versus Surgery Trial (EAST) was a randomized trial that compared, by intention to treat, the clinical outcome and costs of percutaneous transluminal coronary angioplasty (PTCA) and coronary bypass grafting (CABG) for multivessel coronary artery disease. We present the findings of the economic analysis of EAST through 8 years of follow-up and compare the cost and outcomes of patients randomized in EAST versus patients eligible but not randomized (registry patients). Charges were assessed from hospital UB82 and UB92 bills and professional charges from the Emory Clinic. Hospital charges were reduced to cost through step-down accounting methods. All costs and charges were inflated to 1997 dollars. Costs were assessed for initial hospitalization and for cumulative costs of the initial hospitalization and additional revascularization procedures up to 8 years. Total 8-year costs were $46,548 for CABG and $44,491 for PTCA (p = 0.37). Cost of CABG in the eligible registry group showed a pattern similar to that for randomized patients, but total cost of PTCA was lower for registry patients than for randomized patients. Thus, the primary procedural costs of CABG are more than those for PTCA; this cost advantage, given the limits of measurement, is largely or even completely lost for randomized patients over the course of 8 years because of additional procedures after a first revascularization by PTCA.

A systematic review and meta-analysis of trials of social network interventions in type 2 diabetes.

PubMed

Spencer-Bonilla, Gabriela; Ponce, Oscar J; Rodriguez-Gutierrez, Rene; Alvarez-Villalobos, Neri; Erwin, Patricia J; Larrea-Mantilla, Laura; Rogers, Anne; Montori, Victor M

2017-08-21

In the care of patients with type 2 diabetes, self-management is emphasised and studied while theory and observations suggest that patients also benefit from social support. We sought to assess the effect of social network interventions on social support, glycaemic control and quality of life in patients with type 2 diabetes. We searched Ovid MEDLINE, Ovid EBM Reviews, Cochrane Central Register of Controlled Trials, EMBASE, PsycINFO and CINAHL through April 2017 for randomised clinical trials (RCTs) of social network interventions in patients with type 2 diabetes. Reviewers working independently and in duplicate assessed eligibility and risk of bias, and extracted data from eligible RCTs. We pooled estimates using inverse variance random effects meta-analysis. We found 19 eligible RCTs enrolling 2319 participants. Social network interventions were commonly based on individual behaviour change rather than social or interpersonal theories of self-management, were educational, and sought to engage social network members for their knowledge and experience. Interventions improved social support (0.74 SD (95% CI 0.32 to 1.15), I 2 =89%, 8 RCTs) and haemoglobin A1c at 3 months (-0.25 percentage points (95% CI -0.40 to -0.11), I 2 =12%, 9 RCTs), but not quality of life. Despite a compelling theoretical base, researchers have only minimally studied the value of interventions targeting patients' social networks on diabetes care. Although the body of evidence to date is limited, and based on individual behaviour change theories, the results are promising. This review challenges the scientific community to design and test theory-based interventions that go beyond self-management approaches to focus on the largely untapped potential of social networks to improve diabetes care. CRD42016036117. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The Terrible Choice: Re-Evaluating Hospice Eligibility Criteria for Cancer

PubMed Central

Casarett, David J.; Fishman, Jessica M.; Lu, Hien L.; O'Dwyer, Peter J.; Barg, Frances K.; Naylor, Mary D.; Asch, David A.

2009-01-01

Purpose To be eligible for the Medicare Hospice Benefit, cancer patients with a life expectancy of 6 months or less must give up curative treatment. Our goal was to determine whether willingness to make this choice identifies patients with greater need for hospice services. Patients and Methods Three hundred patients with cancer and 171 family members were recruited from six oncology practices. Respondents completed conjoint interviews in which their perceived need for five hospice services was calculated from the choices they made among combinations of services. Patients' preferences for treatment were measured, and patients were followed for 6 months or until death. Results Thirty-eight patients (13%) said they would not want cancer treatment even if it offered an almost 100% chance of 6-month survival. These patients, who would have been eligible for hospice, did not have greater perceived need for hospice services compared with other patients (n = 262; mean, 1.75 v 1.98; Wilcoxon rank sum test, P = .46), nor did their family members (mean, 1.95 v 2.04; Wilcoxon rank sum test, P = .80). Instead, independent predictors of patients' perceived need for hospice services included African American ethnicity, less social support, worse functional status, and a greater burden of psychological symptoms. For families, predictors included caregiver burden, worse self-reported health, working outside the home, and caring for a patient with worse functional status. Conclusion The requirement that patients forgo life-sustaining treatment does not identify patients with greater perceived need for hospice services. Other characteristics offer a better way to identify the patients who are most likely to benefit from hospice. PMID:19114698

Applicability of randomized trials in radiation oncology to standard clinical practice.

PubMed

Apisarnthanarax, Smith; Swisher-McClure, Samuel; Chiu, Wing K; Kimple, Randall J; Harris, Stephen L; Morris, David E; Tepper, Joel E

2013-08-15

Randomized controlled trials (RCTs) are commonly used to inform clinical practice; however, it is unclear how generalizable RCT data are to patients in routine clinical practice. The authors of this report assessed the availability and applicability of randomized evidence guiding medical decisions in a cohort of patients who were evaluated for consideration of definitive management in a radiation oncology clinic. The medical records of consecutive, new patient consultations between January and March 2007 were reviewed. Patient medical decisions were classified as those with (Group 1) or without (Group 2) available, relevant level I evidence (phase 3 RCT) supporting recommended treatments. Group 1 medical decisions were further divided into 3 groups based on the extent of fulfilling eligibility criteria for each RCT: Group 1A included decisions that fulfilled all eligibility criteria; Group 1B, decisions that did not fulfill at least 1 minor eligibility criteria; or Group 1C, decisions that did not fulfill at least 1 major eligibility criteria. Patient and clinical characteristics were tested for correlations with the availability of evidence. Of the 393 evaluable patients, malignancies of the breast (30%), head and neck (18%), and genitourinary system (14%) were the most common presenting primary disease sites. Forty-seven percent of all medical decisions (n = 451) were made without available (36%) or applicable (11%) randomized evidence to inform clinical decision making. Primary tumor diagnosis was significantly associated with the availability of evidence (P < .0001). A significant proportion of medical decisions in an academic radiation oncology clinic were made without available or applicable level I evidence, underscoring the limitations of relying solely on RCTs for the development of evidence-based health care. Copyright © 2013 American Cancer Society.

Is clarithromycin a potential treatment for cachexia in people with lung cancer? A feasibility study.

PubMed

Awan, Sarah; Crosby, Vincent; Potter, Vanessa; Hennig, Ivo; Baldwin, David; Ndlovu, Mehluli; Paradine, Sharon; Wilcock, Andrew

2017-02-01

Clarithromycin may improve cachexia and survival in non-small cell lung cancer (NSCLC), but adequately controlled data are lacking. This study was undertaken primarily to inform the feasibility and scale of a phase III trial. Eligible consenting patients with stage IV NSCLC and cachexia were to be randomized to receive either clarithromycin 250mg twice daily or placebo for eight weeks. Aspects of trial feasibility recorded included numbers eligible, approached and recruited, together with adherence and completion of treatment and assessments. Over 6 months, none of 125 patients identified fulfilled the entry criteria. The commonest reasons for ineligibility were the use of an excluded concurrent drug (45, 36%), brain metastases (22, 18%), poor performance status (21, 17%) and current chemotherapy (15, 12%). A phase III trial of clarithromycin using these entry criteria is not feasible in this setting. Other macrolides that have a lower risk of a drug-drug interaction may be more practical to pursue. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Outcomes of both abbreviated hyper-CVAD induction followed by autologous hematopoietic cell transplantation and conventional chemotherapy for mantle cell lymphoma: a 10-year single-centre experience with literature review.

PubMed

Alwasaidi, Turki Abdulaziz; Hamadah, Abdulaziz; Altouri, Sultan; Tay, Jason; McDiarmid, Sheryl; Faught, Carolyn; Allan, David; Huebsch, Lothar; Bredeson, Christopher; Bence-Bruckler, Isabelle

2015-12-01

We retrospectively evaluated consecutive patients diagnosed with Mantle cell lymphoma (MCL) between 01 January 2000 and 31 December 2009. Eighty eight patients with MCL were included in the analysis of whom 46 (52%) received abbreviated Hyper-CVAD (a total of two cycles; with addition of Rituximab since 2005) with an intention of proceeding to autologous hematopoietic cell transplantation (auto-HCT), with a median age of 58 years. Response rate to induction at auto-HCT time was 89% and complete response was 61%. Forty four patients received an auto-HCT with a 5-year progression-free survival (PFS) and overall survival (OS) were 31.2% and 62.5%, respectively. There were 42 nontransplant eligible patients with a median age of 72 years, and 5-year PFS and OS were 0.0% and 39.9%, respectively. The median survival and PFS in the auto-HCT eligible group were 68 and 33 months, compared to 32 and 12 months in nontransplant eligible group, without a plateauing of the survival curves in either group. Treatment-related mortality in the auto-HCT eligible group was 10.9% (n = 5); two patients died during R-Hyper-CVAD and 3 (6.8%) experienced transplant-related mortality. An abbreviated R-Hyper-CVAD-based induction strategy followed by consolidative auto-HCT is feasible and provides moderate potential of long-term survival. Further research to define risk-adapted strategies; to optimize disease control, is required. © 2015 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Promotion of Home-Based Exercise Training as Secondary Prevention of Coronary Heart Disease: A PILOT WEB-BASED INTERVENTION.

PubMed

Torri, Anna; Panzarino, Claudia; Scaglione, Anna; Modica, Maddalena; Bordoni, Bruno; Redaelli, Raffaella; De Maria, Renata; Ferratini, Maurizio

2018-07-01

Although cardiac rehabilitation (CR) is cost- effective in improving the health of patients with coronary heart disease (CHD), less than half of eligible CHD patients attend a CR program. Innovative web-based technologies might improve CR delivery and utilization. We assessed the feasibility and impact on functional capacity and secondary prevention targets of a long-term web-monitored exercise-based CR maintenance program. Low- to moderate-risk CHD patients were recruited at discharge from inpatient CR after a coronary event or revascularization. We developed an interactive web-based platform for secure home individual access control, monitoring, and validation of exercise training. Of 86 eligible patients, 26 consented to participate in the study intervention (IG). Using a quasi-experimental design, we recruited in parallel 27 eligible patients, unavailable for regular web monitoring, who consented to a follow-up visit as usual care (UC). Among IG, active daily data transmission was 100% during month 1, 88% at month 3, and 81% at 6 months, with sustained improvement in self-reported physical activity beginning with the first week after discharge from inpatient CR (2467 [1854-3554] MET-min/wk) to month 3 (3411 [1981-5347] MET-min/wk, P = .019). Both groups showed favorable changes over time in lipid profile, ventricular function, distance walked in 6 min, and quality of life. At 6 mo, IG achieved a significantly higher proportion of cardiovascular risk factor targets than UC (75 ± 20% vs 59 ± 30%, P = .029). Our web-based home CR maintenance program was feasible, well-accepted, and effective in improving physical activity during 6 mo and achieved higher overall adherence to cardiovascular risk targets than UC.

Consumer perspectives of the Australian Home Medicines Review Program: benefits and barriers.

PubMed

White, Lesley; Klinner, Christiane; Carter, Stephen

2012-01-01

The Australian Home Medicines Review (HMR) is a free consumer service to assist individuals living at home to maximize the benefits of their medicine regimen and prevent medication-related problems. It consists of a pharmacist reviewing a person's medicines and collaborating with the general practitioner to optimize the individual's medicine management. The uptake of this service has remained below the projected use, although the program has shown to successfully identify medication-related problems and improve drug knowledge and adherence of the patient. This study investigates the perceived benefits and barriers of the patients regarding the HMR service who have used the service and who are eligible for it but have never used it. Consumer perceptions were drawn from 14 semistructured focus groups, with patients and carers belonging to the general HMR target population and consumer segments that have been postulated to be underrepresented with regard to this service. The major benefits reported were acquisition of medicine information, reassurance, feeling valued and cared for, and willingness to advocate medication changes to the general practitioner. Perceived barriers were concerns regarding upsetting the general practitioner, pride and independence, confidence issues with an unknown pharmacist, privacy and safety concerns regarding the home visit, and lack of information about the program. Participants agreed that the potential benefits of the service outweighed its potential barriers. It is expected that direct-to-consumer promotion of HMRs would increase the uptake of this valuable service. It would be necessary to ensure that the process and benefits of the service are communicated clearly and sensitively to eligible patients and their carers to obviate common consumer misconceptions and/or barriers regarding the HMR service. Furthermore, any direct-to-consumer promotion of the service must enable patient/carer self-identification of eligibility. Copyright © 2012 Elsevier Inc. All rights reserved.

Implementation of a pharmacist-driven immunization program designed to improve overall vaccination rates in indigent and uninsured patients.

PubMed

Stilwell, Allison M; Pavero, Chris; Buxton, Jennifer; Herrington, Glenn

To demonstrate the results of a pharmacist-driven immunization program designed to increase overall vaccination rates among the low-income, uninsured patients in a free clinic. Cape Fear Clinic, a free clinic located in Wilmington, North Carolina. Cape Fear Clinic provides medical, pharmacy, mental health, and dental services to adults in 4 eastern North Carolina counties who are uninsured and have incomes of no more than 200% of Federal Poverty Guidelines. A pharmacist-driven immunization program consisting of a comprehensive chart review of every active clinic patient in order to improve the vaccination status of the clinic's patients at no cost to the patient. Student pharmacists completed a comprehensive chart review of every active clinic patient to identify patients eligible for immunizations according to the Advisory Committee on Immunization Practices guidelines. More than 500 patients eligible for immunizations were notified of their immunization status and educated about indicated vaccinations. Patients willing to receive indicated vaccinations would present to the pharmacy and a pharmacist or student pharmacist administered the necessary doses. The vaccine initiative was introduced January 1, 2015 and has since delivered 1878 doses of vaccines as of June 30, 2016. The immunization program implemented by pharmacists and student pharmacists at Cape Fear Clinic has been successful in increasing awareness of vaccine preventable diseases as well as increasing rates of vaccination among eligible clinic patients. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Real-world utilization of darbepoetin alfa in cancer chemotherapy patients.

PubMed

Pan, Xiaoyun Lucy; Nordstrom, Beth L; MacLachlan, Sharon; Lin, Junji; Xu, Hairong; Sharma, Anjali; Chandler, David; Li, Xiaoyan Shawn

2017-01-01

Objectives To provide an understanding of darbepoetin alfa dose patterns in cancer patients undergoing myelosuppressive chemotherapy starting from 2011. Study design This is a retrospective cohort study using a proprietary outpatient oncology database. Methods Metastatic, solid tumor cancer patients receiving concomitant myelosuppressive chemotherapy and darbepoetin alfa with an associated hemoglobin <10 g/dL during 2011-2015 were identified. The analysis was restricted to the first continuous exposure to chemotherapy agents (maximum allowable gap of 90 days between consecutive exposures) with darbepoetin alfa for each eligible patient. Initial, maintenance, weekly, and cumulative doses of darbepoetin alfa were examined across all darbepoetin alfa users. Subgroup analyses were conducted by chemotherapy type, baseline hemoglobin level, year of chemotherapy, solid tumor type, and initial dosing schedule. Differences in weekly doses across subgroups were evaluated using Wilcoxon rank-sum tests. Results Among 835 eligible patients, over 90% were 50 years or older. Mean chemotherapy course duration was 248 days, and mean duration of darbepoetin alfa treatment was 106 days. The mean weekly darbepoetin alfa dose was 110 µg. Patients received a mean of 4.3 darbepoetin alfa injections in the first chemotherapy course. There were no statistically significant differences (all P values > .05) in weekly dose by chemotherapy type, baseline hemoglobin level, year of chemotherapy, or solid tumor type. Conclusion The average weekly darbepoetin alfa dose among metastatic cancer patients with chemotherapy-induced anemia from this study was 110 µg, which was lower than the labeled dosage for most adults. This estimate did not differ over time, across chemotherapy regimens, baseline hemoglobin levels, or solid tumor types.

The Relationship Between Magnet Designation, Electronic Health Record Adoption, and Medicare Meaningful Use Payments.

PubMed

Lippincott, Christine; Foronda, Cynthia; Zdanowicz, Martin; McCabe, Brian E; Ambrosia, Todd

2017-08-01

The objective of this study was to examine the relationship between nursing excellence and electronic health record adoption. Of 6582 US hospitals, 4939 were eligible for the Medicare Electronic Health Record Incentive Program, and 6419 were eligible for evaluation on the HIMSS Analytics Electronic Medical Record Adoption Model. Of 399 Magnet hospitals, 330 were eligible for the Medicare Electronic Health Record Incentive Program, and 393 were eligible for evaluation in the HIMSS Analytics Electronic Medical Record Adoption Model. Meaningful use attestation was defined as receipt of a Medicare Electronic Health Record Incentive Program payment. The adoption electronic health record was defined as Level 6 and/or 7 on the HIMSS Analytics Electronic Medical Record Adoption Model. Logistic regression showed that Magnet-designated hospitals were more likely attest to Meaningful Use than non-Magnet hospitals (odds ratio = 3.58, P < .001) and were more likely to adopt electronic health records than non-Magnet hospitals (Level 6 only: odds ratio = 3.68, P < .001; Level 6 or 7: odds ratio = 4.02, P < .001). This study suggested a positive relationship between Magnet status and electronic health record use, which involves earning financial incentives for successful adoption. Continued investigation is needed to examine the relationships between the quality of nursing care, electronic health record usage, financial implications, and patient outcomes.

Perceived difficulty quitting predicts enrollment in a smoking-cessation program for patients with head and neck cancer.

PubMed

Duffy, Sonia A; Scheumann, Angela L; Fowler, Karen E; Darling-Fisher, Cynthia; Terrell, Jeffrey E

2010-05-01

To determine the predictors of participation in a smoking-cessation program among patients with head and neck cancer. This cross-sectional study is a substudy of a larger, randomized trial of patients with head and neck cancer that determined the predictors of smokers' participation in a cessation intervention. Otolaryngology clinics at three Veterans Affairs medical centers (Ann Arbor, MI, Gainesville, FL, and Dallas, TX), and the University of Michigan Hospital in Ann Arbor. 286 patients who had smoked within six months of the screening survey were eligible for a smoking-cessation intervention. Descriptive statistics and bivariate and multivariate logistic regression were used to determine the independent predictors of smokers' participation in an intervention study. Perceived difficulty quitting (as a construct of self-efficacy), health behaviors (i.e., smoking and problem drinking), clinical characteristics (i.e., depression and cancer site and stage), and demographic variables. Forty-eight percent of those eligible participated. High perceived difficulty quitting was the only statistically significant predictor of participation, whereas problem drinking, lower depressive symptoms, and laryngeal cancer site approached significance. Special outreach may be needed to reach patients with head and neck cancer who are overly confident in quitting, problem drinkers, and patients with laryngeal cancer. Oncology nurses are in an opportune position to assess patients' perceived difficulty quitting smoking and motivate them to enroll in cessation programs, ultimately improving quality of life, reducing risk of recurrence, and increasing survival for this population.

ESC Study Group of Sports Cardiology: recommendations for participation in leisure-time physical activity and competitive sports for patients with ischaemic heart disease.

PubMed

Börjesson, Mats; Assanelli, Deodato; Carré, François; Dugmore, Dorian; Panhuyzen-Goedkoop, Nicole M; Seiler, Christian; Senden, Jeff; Solberg, Erik E

2006-04-01

Evidence for the proper management of ischemic heart disease (IHD) in the general population is well established, but recommendations for physical activity and competitive sports in these patients are scarce. The aim of the present paper was to provide such recommendations to complement existing ESC and international guidelines on rehabilitation and primary/secondary prevention. Due to the lack of studies in this field, the current recommendations are the result of consensus among experts. Sports are classified into low/moderate/high dynamic and low/moderate/high static, respectively. Patients with a definitive IHD and higher probability of cardiac events are not eligible for competitive sports (CS) but for individually designed leisure time physical activity (LPA); patients with definitive IHD and lower probability of cardiac events as well as those with no IHD but with a positive exercise test and high risk profile (SCORE > 5%) are eligible for low/moderate static and low dynamic (IA-IIA) sports and individually designed LPA. Patients without IHD and a high risk profile+ a negative exercise-test and those with a low risk profile (SCORE < 5%) are allowed all LPA and competitive sports with a few exceptions. Individually designed LPA is possible and encouraged in patients with and without established IHD. Competitive sports may be restricted for patients with IHD, depending on the probability of cardiac events and the demands of the sport according to the current classification.

Can Patient Navigation Improve Receipt of Recommended Breast Cancer Care? Evidence From the National Patient Navigation Research Program

PubMed Central

Ko, Naomi Y.; Darnell, Julie S.; Calhoun, Elizabeth; Freund, Karen M.; Wells, Kristin J.; Shapiro, Charles L.; Dudley, Donald J.; Patierno, Steven R.; Fiscella, Kevin; Raich, Peter; Battaglia, Tracy A.

2014-01-01

Purpose Poor and underserved women face barriers in receiving timely and appropriate breast cancer care. Patient navigators help individuals overcome these barriers, but little is known about whether patient navigation improves quality of care. The purpose of this study is to examine whether navigated women with breast cancer are more likely to receive recommended standard breast cancer care. Patients and Methods Women with breast cancer who participated in the national Patient Navigation Research Program were examined to determine whether the care they received included the following: initiation of antiestrogen therapy in patients with hormone receptor–positive breast cancer; initiation of postlumpectomy radiation therapy; and initiation of chemotherapy in women younger than age 70 years with triple-negative tumors more than 1 cm. This is a secondary analysis of a multicenter quasi-experimental study funded by the National Cancer Institute to evaluate patient navigation. Multiple logistic regression was performed to compare differences in receipt of care between navigated and non-navigated participants. Results Among participants eligible for antiestrogen therapy, navigated participants (n = 380) had a statistically significant higher likelihood of receiving antiestrogen therapy compared with non-navigated controls (n = 381; odds ratio [OR], 1.73; P = .004) in a multivariable analysis. Among the participants eligible for radiation therapy after lumpectomy, navigated participants (n = 255) were no more likely to receive radiation (OR, 1.42; P = .22) than control participants (n = 297). Conclusion We demonstrate that navigated participants were more likely than non-navigated participants to receive antiestrogen therapy. Future studies are required to determine the full impact patient navigation may have on ensuring that vulnerable populations receive quality care. PMID:25071111

Report of a multicenter phase II trial testing a combination of biweekly bevacizumab and daily erlotinib in patients with unresectable biliary cancer: a phase II Consortium study.

PubMed

Lubner, Sam J; Mahoney, Michelle R; Kolesar, Jill L; Loconte, Noelle K; Kim, George P; Pitot, Henry C; Philip, Philip A; Picus, Joel; Yong, Wei-Peng; Horvath, Lisa; Van Hazel, Guy; Erlichman, Charles E; Holen, Kyle D

2010-07-20

Biliary cancers overexpress epidermal growth factor receptor (EGFR), and angiogenesis has been correlated with poor outcome. Erlotinib, an EGFR tyrosine kinase inhibitor, and bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor have each been shown to have activity in biliary cancer. The primary objective of this study was to evaluate the response rate by Response Evaluation Criteria in Solid Tumors (RECIST). Secondary end points included overall survival (OS), time to progression (TTP), VEGF levels, and molecular studies of EGFR and k-ras. Eligible patients had advanced cholangiocarcinoma or gallbladder cancer. Patients were treated with bevacizumab 5 mg/kg intravenously on days 1 and 15 and erlotinib 150 mg by mouth daily on days 1 through 28. Responses were evaluated by RECIST. VEGF levels were collected, and samples were analyzed for EGFR mutation by polymerase chain reaction. Fifty-three eligible patients were enrolled at eight sites. Of 49 evaluable patients, six (12%; 95% CI, 6% to 27%) had a confirmed partial response. Stable disease was documented in another 25 patients (51%). Rash was the most common grade 3 toxicity. Four patients had grade 4 toxicities. Median OS was 9.9 months, and TTP was 4.4 months. Low repeats (< 16) in EGFR intron 1 polymorphism and G>G k-ras Q38 genotype (wild type) were associated with improved outcomes. Combination chemotherapy with bevacizumab and erlotinib showed clinical activity with infrequent grade 3 and 4 adverse effects in patients with advanced biliary cancers. On the basis of preliminary molecular analysis, presence of a k-ras mutation may alter erlotinib efficacy. The combination of bevacizumab and erlotinib may be a therapeutic alternative in patients with advanced biliary cancer.

Influenza vaccination, inverse care and homelessness: cross-sectional survey of eligibility and uptake during the 2011/12 season in London

PubMed Central

2014-01-01

Background Influenza vaccination eligibility and uptake among homeless adults has not been previously assessed in the UK. This cross-sectional survey aimed to measure the proportion of homeless people visited by an NHS outreach service (Find and Treat) who were eligible for and had received vaccination during 2011/12. Methods A cross-sectional survey was carried out in 27 separate homeless hostels, day centres and drug services in London between July and August in 2012. Eligibility for the survey was by virtue of being in attendance at one of 27 venues visited by Find and Treat. No specific exclusion criteria were used. Results 455 clients took part in the survey out of 592 approached (76.9%). A total of 190 homeless people (41.8%; 95% CI: 34.5,50.5) were eligible for influenza vaccination. In those aged 16–64, eligibility due to clinical risk factors was 38.9% (95% CI: 31.5,48.2). Uptake of vaccination in homeless 16–64 year olds with a clinical risk factor during the 2011/12 influenza season was 23.7% (95% CI: 19.8,28.3) compared to national levels of 53.2% (excluding pregnant women). In those aged over 65, uptake was 42.9% (95% CI: 16.7,100.0) compared with 74.0% nationally. Conclusions This study demonstrates that the homeless population have high levels of chronic health problems predisposing them to severe complications of influenza, but vaccine uptake levels that are less than half those seen among eligible GP patient groups in England. It provides a clear example of the health inequalities and inverse care law that impact this population. The results of this study provide strong justification for intensifying efforts to ensure homeless people have access to influenza vaccination. PMID:24433371

Analysis of a continuous series of 34 young patients with early-stage cervical cancer selected for a vaginal radical trachelectomy: should "staging" conization be systematically performed before this procedure?

PubMed

Uzan, Catherine; Gouy, Sebastien; Desroque, Delphine; Pomel, Christophe; Duvillard, Pierre; Balleyguier, Corrine; Haie-Meder, Christine; Morice, Philippe

2013-02-01

Vaginal radical trachelectomy (VRT) is the most widely evaluated form of conservative management of young patients with early-stage (IB1) cervical cancer. Patients with nodal involvement or a tumor size greater than 2 cm are not eligible for such treatment. The aim of this study is to report the impact of a "staging" conization before VRT. This is a retrospective study of 34 patients potentially selected for VRT for a clinical and radiologic cervical tumor less than 2 cm. Among them, 28 underwent finally a VRT (20 of them having a previous conization before this procedure) and 6 patients with macroscopic cervical cancer, confirmed by punch biopsies, "eligible" for VRT (<2 cm) had undergone "staging" conization (without further VRT) to confirm the tumor size and lymphovascular space involvement (LVSI) status. Six patients having "staging" conization before VRT had finally been deemed contraindications to VRT due to the presence of a histologically confirmed tumor greater than 2 cm and/or associated with multiple foci of LVSI. Among 28 patients who underwent VRT, 1 received adjuvant chemoradiation (this patient recurred and died of disease). Two patients treated with RVT (without postoperative treatment) recurred. Ten pregnancies (9 spontaneous and 1 induced) were observed in 9 patients. Among 4 patients with macroscopic "visible" tumor who do not underwent a "staging" conization before VRT, 2 recurred. Among 11 patients who underwent VRT and having LVSI, 3 recurred. These results suggest that if a conization is not performed initially, it should then be included among the staging procedures to select patients for VRT.

Correlation of psoriasis activity with socioeconomic status: cross-sectional analysis of patients enrolled in the Psoriasis Longitudinal Assessment and Registry (PSOLAR).

PubMed

Kimball, A B; Augustin, M; Gordon, K B; Krueger, G G; Pariser, D; Fakharzadeh, S; Goyal, K; Calabro, S; Lee, S; Lin, R; Li, N; Srivastava, B; Guenther, L

2018-05-10

The interdependence between socioeconomic status and disease control in patients with severe psoriasis is not well understood. To assess whether worse disease control among patients with historically severe psoriasis correlated with negative socioeconomic status, we conducted a cross-sectional analysis from Psoriasis Longitudinal Assessment and Registry (PSOLAR), a large, observational study of psoriasis patients receiving, or eligible to receive, conventional systemic or biologic therapies. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Medicare home health care patient case-mix before and after the Balanced Budget Act of 1997: effect on dual eligible beneficiaries.

PubMed

Shih, Huai-Che; Temkin-Greener, Helena; Votava, Kathryn; Friedman, Bruce

2014-01-01

The Balanced Budget Act (BBA) of 1997 changed the payment system for Medicare home health care (HHC) from cost-based to prospective reimbursement. We used Medical Expenditure Panel Survey data to assess the impact of the BBA on Medicare HHC patient case-mix measured by the Centers for Medicare and Medicaid Services Hierarchical Condition Categories (CMS-HCC) model. There was a significant increase in Medicare HHC patient case-mix between the pre-BBA and Prospective Payment System (PPS) periods. The increase in the standardized-predicted risk score from the Interim Payment System period to PPS was nearly 4 times greater for the dual eligibles (Medicare-Medicaid) than for the Medicare-only population. This significantly greater rise in the HHC resources required by dual eligibles as compared to nonduals could be due to a shift in HHC payers from Medicare only to Medicaid rather than be an actual increase in case-mix per se.

Defunctioning ileostomy reduces leakage rate in rectal cancer surgery - systematic review and meta-analysis.

PubMed

Pisarska, Magdalena; Gajewska, Natalia; Małczak, Piotr; Wysocki, Michał; Witowski, Jan; Torbicz, Grzegorz; Major, Piotr; Mizera, Magdalena; Dembiński, Marcin; Migaczewski, Marcin; Budzyński, Andrzej; Pędziwiatr, Michał

2018-04-17

The role of a defunctioning ileostomy in every anterior rectal resection with total mesorectal excision (TME) is still controversial. In this study, we aimed to review the current literature to determine the impact of ileostomy creation on postoperative outcomes in patients undergoing anterior rectal resection with TME. MEDLINE, Embase and Cochrane Library were searched for eligible studies. We analyzed data up to October 2017. Eligible studies had to compare patients with vs. without a defunctioning ileostomy in rectal cancer surgery and comprise data on anastomotic leakage in both groups. The primary outcome was anastomotic leakage. Secondary outcomes included the complication rate, mortality, reoperation rate, length of hospital stay and 30-day readmission. Initial search yielded 1,966 articles. Thorough evaluation resulted in 13 eligible articles which were analyzed. Leakage rate (RR = 0.43, 95% CI 0.28-0.67) and the number of reoperations (RR = 0.62, 95% CI 0.40-0.94) were significantly lower in the defunctioning stoma group. Morbidity was significantly higher in the stoma group (RR = 1.32, 95% CI 1.05-1.65). Analysis of mortality, length of hospital stay and readmission rate did not show any significant differences. A defunctioning ileostomy may decrease the anastomotic leakage rate, additionally significantly reducing the risk of reoperations but it may also increase the overall complication rate. The presence of the protective stoma has no effect on mortality, length of hospital stay and readmission rate.

Evaluation of a clinical decision support algorithm for patient-specific childhood immunization.

PubMed

Zhu, Vivienne J; Grannis, Shaun J; Tu, Wanzhu; Rosenman, Marc B; Downs, Stephen M

2012-09-01

To evaluate the effectiveness of a clinical decision support system (CDSS) implementing standard childhood immunization guidelines, using real-world patient data from the Regenstrief Medical Record System (RMRS). Study subjects were age 6-years or younger in 2008 and had visited the pediatric clinic on the campus of Wishard Memorial Hospital. Immunization records were retrieved from the RMRS for 135 randomly selected pediatric patients. We compared vaccine recommendations from the CDSS for both eligible and recommended timelines, based on the child's date of birth and vaccine history, to recommendations from registered nurses who routinely selected vaccines for administration in a busy inner city hospital, using the same date of birth and vaccine history. Aggregated and stratified agreement and Kappa statistics were reported. The reasons for disagreement between suggestions from the CDSS and nurses were also identified. For the 135 children, a total of 1215 vaccination suggestions were generated by nurses and were compared to the recommendations of the CDSS. The overall agreement rates were 81.3% and 90.6% for the eligible and recommended timelines, respectively. The overall Kappa values were 0.63 for the eligible timeline and 0.80 for the recommended timeline. Common reasons for disagreement between the CDSS and nurses were: (1) missed vaccination opportunities by nurses, (2) nurses sometimes suggested a vaccination before the minimal age and minimal waiting interval, (3) nurses usually did not validate patient immunization history, and (4) nurses sometimes gave an extra vaccine dose. Our childhood immunization CDSS can assist providers in delivering accurate childhood vaccinations. Copyright © 2012 Elsevier B.V. All rights reserved.

Application of New Cholesterol Guidelines to the Korean Adult Diabetic Patients.

PubMed

Kim, Bu Kyung; Kim, Hyeon Chang; Ha, Kyoung Hwa; Kim, Dae Jung

2015-11-01

The American College of Cardiology and the American Heart Association (ACC/AHA) 2013 joint guidelines for the treatment of hypercholesterolemia expand the indications for statin therapy. This study was performed to estimate the numbers of diabetic patients indicated for statin therapy according to the Third Adult Treatment Panel (ATP-III) of the National Cholesterol Education Program guidelines and the new ACC/AHA guidelines in Korea. We analyzed the data from the Korea National Health and Nutrition Examination Survey (KNHANES) 2010-2012. Patients with diabetes over 30 yr of age were analyzed by the two guidelines. Of the total 1,975 diabetic patients, only 377 (19.1%) were receiving drugs for dyslipidemia. Among 1,598 patients who had not taken any medications for dyslipidemia, 65.6% would be indicated for statin therapy according to the ATP-III guidelines. When we apply the new guidelines, 94.3% would be eligible for statin therapy. Among the total diabetic patients, the new guidelines, compared with the ATP-III guidelines, increase the number eligible for statin therapy from 53.1% to 76.2%. The new guidelines would increase the indication for statin therapy for most diabetic patients. At present, many diabetic patients do not receive appropriate statin therapy. Therefore efforts should be made to develop the Korean guidelines and to ensure that more diabetic patients receive appropriate statin therapy.

Does bariatric surgery prevent progression of diabetic retinopathy?

PubMed

Chen, Y; Laybourne, J P; Sandinha, M T; de Alwis, N M W; Avery, P; Steel, D H

2017-08-01

PurposeTo assess the changes in diabetic retinopathy (DR) in type 2 diabetes (T2DM) patients post bariatric surgery and report on the risk factors that may be associated with it.Patients and methodsRetrospective observational study of T2DM patients who underwent bariatric surgery in a UK specialist bariatric unit between 2009 and 2015. Preoperative and postoperative weight, HbA1c, and annual DR screening results were collected from medical records. Patients with preoperative retinal screening and at least one postoperative retinal screening were eligible for analysis. Multivariate analysis was used to explore significant clinical predictors on postoperative worsening in DR.ResultsA total of 102 patients were eligible for analysis and were followed up for 4 years. Preoperatively, 68% of patients had no DR compared to 30% with background retinopathy, 1% pre-proliferative retinopathy, and 1% proliferative retinopathy. In the first postoperative visit, 19% of patients developed new DR compared to 70% stable and 11% improved. These proportions remained similar for each postoperative visit over time. Young age, male gender, high preoperative HbA1c, and presence of preoperative retinopathy were the significant predictors of worsening postoperatively.ConclusionBariatric surgery does not prevent progression of DR. Young male patients with pre-existing DR and poor preoperative glycaemic control are most at risk of progression. All diabetic patients should attend regular DR screening post bariatric surgery to allow early detection of potentially sight-threatening changes, particularly among those with identifiable risk factors. Future prospective studies with prolonged follow-up are required to clarify the duration of risk.

Lung protective mechanical ventilation and two year survival in patients with acute lung injury: prospective cohort study

PubMed Central

Colantuoni, Elizabeth; Mendez-Tellez, Pedro A; Dinglas, Victor D; Sevransky, Jonathan E; Dennison Himmelfarb, Cheryl R; Desai, Sanjay V; Shanholtz, Carl; Brower, Roy G; Pronovost, Peter J

2012-01-01

Objective To evaluate the association of volume limited and pressure limited (lung protective) mechanical ventilation with two year survival in patients with acute lung injury. Design Prospective cohort study. Setting 13 intensive care units at four hospitals in Baltimore, Maryland, USA. Participants 485 consecutive mechanically ventilated patients with acute lung injury. Main outcome measure Two year survival after onset of acute lung injury. Results 485 patients contributed data for 6240 eligible ventilator settings, as measured twice daily (median of eight eligible ventilator settings per patient; 41% of which adhered to lung protective ventilation). Of these patients, 311 (64%) died within two years. After adjusting for the total duration of ventilation and other relevant covariates, each additional ventilator setting adherent to lung protective ventilation was associated with a 3% decrease in the risk of mortality over two years (hazard ratio 0.97, 95% confidence interval 0.95 to 0.99, P=0.002). Compared with no adherence, the estimated absolute risk reduction in two year mortality for a prototypical patient with 50% adherence to lung protective ventilation was 4.0% (0.8% to 7.2%, P=0.012) and with 100% adherence was 7.8% (1.6% to 14.0%, P=0.011). Conclusions Lung protective mechanical ventilation was associated with a substantial long term survival benefit for patients with acute lung injury. Greater use of lung protective ventilation in routine clinical practice could reduce long term mortality in patients with acute lung injury. Trial registration Clinicaltrials.gov NCT00300248. PMID:22491953

Preliminary audiologic and peri-operative outcomes of the Sophono™ transcutaneous bone conduction device: A systematic review.

PubMed

Bezdjian, Aren; Bruijnzeel, Hanneke; Daniel, Sam J; Grolman, Wilko; Thomeer, Hans G X M

2017-10-01

To delineate the auditory functional improvement and peri-operative outcomes of the Sophono™ transcutaneous bone conduction device. Eligible articles presenting patients implanted with the Sophono™ were identified through a comprehensive search of PubMed and Embase electronic databases. All relevant articles were reviewed to justify inclusion independently by 2 authors. Studies that successfully passed critical appraisal for directness of evidence and risk of bias were included. From a total of 125 articles, 8 studies encompassing 86 patients using 99 implants were selected. Most patients (79.1%) were children. Ear atresia (67.5%) was the most frequently reported indication for Sophono™ implantation. Overall pure tone average auditory improvement was 31.10 (±8.29) decibel. During a mean follow-up time of 12.48 months, 25 patients (29%) presented with post-operative complications from which 3 were deemed as serious implant-related adverse events (3.5%). The Sophono™ transcutaneous bone conduction device shows promising functional improvement, no intra-operative complications and minor post-operative skin related complications. If suitable, the device could be a proposed solution for the rehabilitation of hearing in children meeting eligibility criteria. A wearing schedule must be implemented in order to reduce magnet-related skin complications. Copyright © 2017 Elsevier B.V. All rights reserved.

Classical Hodgkin's lymphoma: the Lymphoma Study Association guidelines for relapsed and refractory adult patients eligible for transplant.

PubMed

Van Den Neste, Eric; Casasnovas, Olivier; André, Marc; Touati, Mohamed; Senecal, Delphine; Edeline, Véronique; Stamatoullas, Aspasia; Fornecker, Luc; Deau, Bénédicte; Gastinne, Thomas; Reman, Oumédaly; Gaillard, Isabelle; Borel, Cécile; Brice, Pauline; Fermé, Christophe

2013-08-01

The Hodgkin's Lymphoma Committee of the Lymphoma Study Association (LYSA) gathered in 2012 to prepare guidelines on the management of transplant-eligible patients with relapsing or refractory Hodgkin's lymphoma. The working group is made up of a multidisciplinary panel of experts with a significant background in Hodgkin's lymphoma. Each member of the panel of experts provided an interpretation of the evidence and a systematic approach to obtain consensus was used. Grades of recommendation were not required since levels of evidence are mainly based on phase II trials or standard practice. Data arising from randomized trials are emphasized. The final version was endorsed by the scientific council of the LYSA. The expert panel recommends a risk-adapted strategy (conventional treatment, or single/double transplantation and/or radiotherapy) based on three risk factors at progression (primary refractory disease, remission duration < 1 year, stage III/IV), and an early evaluation of salvage chemosensitivity, including (18)fluorodeoxy glucose-positron emission tomography interpreted according to the Deauville scoring system. Most relapsed or refractory Hodgkin's lymphoma patients chemosensitive to salvage should receive high-dose therapy and autologous stem-cell transplantation as standard. Efforts should be made to increase the proportion of chemosensitive patients by alternating non-cross-resistant chemotherapy lines or exploring the role of novel drugs.

Cost-effectiveness of Out-of-Hospital Continuous Positive Airway Pressure for Acute Respiratory Failure

PubMed Central

Thokala, Praveen; Goodacre, Steve; Ward, Matt; Penn-Ashman, Jerry; Perkins, Gavin D.

2015-01-01

Study objective We determine the cost-effectiveness of out-of-hospital continuous positive airway pressure (CPAP) compared with standard care for adults presenting to emergency medical services with acute respiratory failure. Methods We developed an economic model using a United Kingdom health care system perspective to compare the costs and health outcomes of out-of-hospital CPAP to standard care (inhospital noninvasive ventilation) when applied to a hypothetical cohort of patients with acute respiratory failure. The model assigned each patient a probability of intubation or death, depending on the patient’s characteristics and whether he or she had out-of-hospital CPAP or standard care. The patients who survived accrued lifetime quality-adjusted life-years (QALYs) and health care costs according to their age and sex. Costs were accrued through intervention and hospital treatment costs, which depended on patient outcomes. All results were converted into US dollars, using the Organisation for Economic Co-operation and Development purchasing power parities rates. Results Out-of-hospital CPAP was more effective than standard care but was also more expensive, with an incremental cost-effectiveness ratio of £20,514 per QALY ($29,720/QALY) and a 49.5% probability of being cost-effective at the £20,000 per QALY ($29,000/QALY) threshold. The probability of out-of-hospital CPAP’s being cost-effective at the £20,000 per QALY ($29,000/QALY) threshold depended on the incidence of eligible patients and varied from 35.4% when a low estimate of incidence was used to 93.8% with a high estimate. Variation in the incidence of eligible patients also had a marked influence on the expected value of sample information for a future randomized trial. Conclusion The cost-effectiveness of out-of-hospital CPAP is uncertain. The incidence of patients eligible for out-of-hospital CPAP appears to be the key determinant of cost-effectiveness. PMID:25737210

A Phase 2 Trial of Once-Weekly Hypofractionated Breast Irradiation: First Report of Acute Toxicity, Feasibility, and Patient Satisfaction

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dragun, Anthony E., E-mail: aedrag01@louisville.edu; Quillo, Amy R.; Riley, Elizabeth C.

2013-03-01

Purpose: To report on early results of a single-institution phase 2 trial of a 5-fraction, once-weekly radiation therapy regimen for patients undergoing breast-conserving surgery (BCS). Methods and Materials: Patients who underwent BCS for American Joint Committee on Cancer stage 0, I, or II breast cancer with negative surgical margins were eligible to receive whole breast radiation therapy to a dose of 30 Gy in 5 weekly fractions of 6 Gy with or without an additional boost. Elective nodal irradiation was not permitted. There were no restrictions on breast size or the use of cytotoxic chemotherapy for otherwise eligible patients. Patientsmore » were assessed at baseline, treatment completion, and at first posttreatment follow-up to assess acute toxicity (Common Terminology Criteria for Adverse Events, version 3.0) and quality of life (European Organization for Research and Treatment of Cancer QLQ-BR23). Results: Between January and September 2011, 42 eligible patients underwent weekly hypofractionated breast irradiation immediately following BCS (69.0%) or at the conclusion of cytotoxic chemotherapy (31.0%). The rates of grade ≥2 radiation-induced dermatitis, pain, fatigue, and breast edema were 19.0%, 11.9%, 9.5%, and 2.4%, respectively. Only 1 grade 3 toxicity—pain requiring a course of narcotic analgesics—was observed. One patient developed a superficial cellulitis (grade 2), which resolved with the use of oral antibiotics. Patient-reported moderate-to-major breast symptoms (pain, swelling, and skin problems), all decreased from baseline through 1 month, whereas breast sensitivity remained stable over the study period. Conclusions: The tolerance of weekly hypofractionated breast irradiation compares well with recent reports of daily hypofractionated whole-breast irradiation schedules. The regimen appears feasible and cost-effective. Additional follow-up with continued accrual is needed to assess late toxicity, cosmesis, and disease-specific outcomes.« less

An Australian government dental scheme: Doctor-dentist-patient tensions in the triangle.

PubMed

Weerakoon, Arosha; Fitzgerald, Lisa; Porter, Suzette

2014-11-30

Autonomy of participants is challenged when legislation to provide a public health service is weakly designed and implemented. Australia's Chronic Disease Dental Scheme was instigated to provide a government subsidy for private dental treatment for people suffering chronic illness impacting their oral health or vice versa. They were allocated AUD$4250 towards comprehensive treatment over 2 years with their eligibility determined by their general medical doctor. A qualitative research study was conducted to explore the experiences from the perspectives of the patient, medical and dental practitioner. One of the research outcomes identified a frequently reported level of discomfort in the patient/doctor/dentist triangle. Doctors and dentists reported feeling forced by patients into positions that compromised their autonomy in obeying the intent (if not the law) of the scheme. Additionally, dentists felt under pressure from doctors and patients to provide subsidized treatment to those eligible. In turn, the patients reported difficulties in gaining access to the scheme and in some cases, experiencing full or partially unmet oral health needs. REASON FOR CONFLICT: Poor inter-professional communication and lack of understanding about profession-unique patient-driven pressures, ultimately contributed to dissonance. Ill-defined eligibility guidelines rendered the doctor's ability to gate-keep challenging. OUTCOME OF CONFLICT: Inefficient gate-keeping led to exponential increase in referrals, resulting in unprecedented cost blow-outs. Ensuing government-led audits caused political tensions and contributed to the media-induced vilification of dentists. In December 2013, government financing of dental treatment through Chronic Disease Dental Scheme was discontinued, leaving many Australians without a viable alternative. There is a need for qualitative research methods to help identify social issues that affect public health policy process. In order to succeed, new health policies should respect, consider and attempt to understand the autonomy of key participants, prior to and throughout.

Indicators of patients with major depressive disorder in need of highly specialized care: A systematic review.

PubMed

van Krugten, Frédérique C W; Kaddouri, Meriam; Goorden, Maartje; van Balkom, Anton J L M; Bockting, Claudi L H; Peeters, Frenk P M L; Hakkaart-van Roijen, Leona

2017-01-01

Early identification of patients with major depressive disorder (MDD) that cannot be managed by secondary mental health services and who require highly specialized mental healthcare could enhance need-based patient stratification. This, in turn, may reduce the number of treatment steps needed to achieve and sustain an adequate treatment response. The development of a valid tool to identify patients with MDD in need of highly specialized care is hampered by the lack of a comprehensive understanding of indicators that distinguish patients with and without a need for highly specialized MDD care. The aim of this study, therefore, was to systematically review studies on indicators of patients with MDD likely in need of highly specialized care. A structured literature search was performed on the PubMed and PsycINFO databases following PRISMA guidelines. Two reviewers independently assessed study eligibility and determined the quality of the identified studies. Three reviewers independently executed data extraction by using a pre-piloted, standardized extraction form. The resulting indicators were grouped by topical similarity, creating a concise summary of the findings. The systematic search of all databases yielded a total of 7,360 references, of which sixteen were eligible for inclusion. The sixteen papers yielded a total of 48 unique indicators. Overall, a more pronounced depression severity, a younger age of onset, a history of prior poor treatment response, psychiatric comorbidity, somatic comorbidity, childhood trauma, psychosocial impairment, older age, and a socioeconomically disadvantaged status were found to be associated with proxies of need for highly specialized MDD care. Several indicators are associated with the need for highly specialized MDD care. These indicators provide easily measurable factors that may serve as a starting point for the development of a valid tool to identify patients with MDD in need of highly specialized care.

The effectiveness of virtual reality on reducing pain and anxiety in burn injury patients: a systematic review.

PubMed

Morris, Linzette Deidré; Louw, Quinette Abegail; Grimmer-Somers, Karen

2009-01-01

To systematically review the current evidence for the effectiveness of Virtual Reality (VR), in conjunction with pharmacologic analgesia on reducing pain and anxiety in burn injury patients undergoing wound dressing changes and physiotherapy management compared with pharmacologic analgesia alone or other forms of distraction. A comprehensive search was conducted between December 2007 and January 2008, and updated in January 2009, before publication. Computerized bibliographic databases were individually searched using specifically developed search strategies to identify eligible studies. Nine studies were deemed eligible for inclusion in this review. Wound dressing changes was the most common procedure during which VR was trialed. Pain was the primary outcome measure in all of the studies included. Anxiety was a secondary outcome measure in 3 of the 9 included studies. VR, in conjunction with pharmacologic analgesics, significantly reduced pain experienced by burn injury patients during wound dressing changes and physiotherapy. There is equivocal evidence for the effect of VR in conjunction with pharmacologic analgesics on reducing anxiety in burn injury patients during wound dressing changes and physiotherapy. This is the first known systematic review to report on the effectiveness of VR, in conjunction with pharmacologic analgesia on reducing pain and anxiety in burn injury patients undergoing wound dressing changes and physiotherapy management compared with pharmacologic analgesia alone or other forms of distraction. Used as an adjunct to the current burn pain management regimens, VR could possibly assist health professionals in making the rehabilitation process for burn patients less excruciating, thereby improving functional outcomes. Further research investigating the effect of VR on anxiety in burn injury patients is warranted.

Qualitative Study on the Perceptions of Terminally Ill Cancer Patients and Their Family Members Regarding End-of-Life Experiences Focusing on Palliative Sedation.

PubMed

Eun, Young; Hong, In-Wha; Bruera, Eduardo; Kang, Jung Hun

2017-06-01

Patients with terminal cancer experience refractory symptoms in the last days of life. Although palliative sedation (PS) is recommended for patients suffering unbearable symptoms with imminent death, it requires clear communication between physicians and patients/caregivers. Understanding the demands and perceptions of patients and caregivers in the end-of-life phase are needed for effective communication. To explore patient experiences regarding end-of-life status and PS. The study was performed between October and December, 2013 with eligible terminal cancer patients and their families in a non-religious, tertiary healthcare facility in Korea. Eligibility criteria were a hospitalized cancer patient with a life expectancy of less than three months and who had never experienced PS. Data were collected via face-to-face in-depth interviews and analyzed using the constant comparative method of qualitative analysis. Saturation was achieved after conducting interviews with 13 patients or care-giving family members. Enrolled patients raised the following issues: 1) simultaneously harboring the hope of prolonging life and wishing for a peaceful death, 2) experiencing difficulties in having honest conversations with caregivers regarding death, 3) possessing insufficient knowledge and information regarding PS, and 4) hoping for the decision on PS to be made before suffering becomes too great. Terminally ill cancer patients and their caregivers expressed conflicting desires in hoping to prolong life and simultaneously wishing to experience a peaceful death. Improvements in the communications that occur among physicians, patients, and caregivers on the issues of prognosis and PS are needed. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Stress, Psychosocial Mediators, and Cognitive Mediators in Parents of Child Cancer Patients and Cancer Survivors: Attention and Working Memory Pathway Perspectives.

PubMed

Vander Haegen, Marie; Luminet, Olivier

2015-01-01

This review examines stress and its consequences on attention and working memory, stress symptoms in parents of child cancer patients and survivors and long-term consequences of stress on cognitive processing in parents of child cancer survivors. Eligible studies were experimental, meta-analyses, and qualitative (2000-2013) from Pubmed, Medline, the Cochrane Library, PsycArticles, and Google Scholar. We identified 92 eligible papers. They showed that elevated stress can impede performances on tasks requiring attention and memory patterns. In pediatric oncology, parental stress increased shortly after diagnosis involving depression and anxiety. Consequences of stress on cognitive performances were observed mainly among depressed individuals. As regards parents of child cancer survivors, female gender, low Socioeconomic Status (SES), and innate traits of anxiety/anger predicted the development of PTSS. Evidence of stress on attention and working memory processes in parents of child cancer survivors is insufficiently developed.

Guideline-Based Statin Eligibility, Cancer Events, and Noncardiovascular Mortality in the Framingham Heart Study.

PubMed

Pursnani, Amit; Massaro, Joseph M; D'Agostino, Ralph B; O'Donnell, Christopher J; Hoffmann, Udo

2017-09-01

Purpose Cancer and cardiovascular disease share risk factors, and there is some evidence that statins reduce cancer mortality. We sought to determine the accuracy of the 2013 American College of Cardiology/American Heart Association statin eligibility criteria to identify individuals at a higher risk of developing cancer or of dying as a result of cancer or other noncardiovascular causes. Methods We included 2,196 participants (50.5 ± 8.1 years of age; 55% female) who were statin naïve and free of cancer at baseline from the offspring and third-generation cohorts of the community-based longitudinal Framingham Heart Study. Statin eligibility was determined per American College of Cardiology/American Heart Association guidelines, and subclinical coronary atherosclerosis was assessed by computed tomography. The primary outcome was incident cancer at a median of 10.0 years (interquartile range, 9.1-10.6 years) of follow-up, and secondary outcomes were cancer mortality and noncardiovascular mortality. Results The incident cancer rate was 11.2% (247 of 2,196), with 58 noncardiovascular deaths, including 39 cancer deaths (1.8%). Overall, 37% (812 of 2,196) were statin eligible. Incident cancer occurred in 125 (15%) of the 812 statin-eligible participants versus 122 (8.8%) of the 1,384 of noneligible participants (subdistribution hazard ratio [SDHR], 1.8 [1.4 to 2.3]; P < .001). Cancer mortality occurred in 34 (4.2%) of the 812 statin-eligible participants versus five (0.4%) of the 1,384 noneligible participants (SDHR, 12.1 [4.7 to 31]; P < .001). Noncardiovascular mortality occurred in 49 (6.0%) of the 812 statin-eligible participants versus nine (0.7%) of the 1,384 noneligible participants (SDHR, 10.1 [5.0 to 21]; P < .001). In stratified analyses, these findings were independent of any individual causative risk factor such as body mass index, age, or smoking status. Conclusion In this community-based primary prevention cohort, guideline-based statin eligibility accurately identified patients at a higher risk of developing cancer and cancer-related mortality. Shared risk profiles and potential benefits of statins between cancer and cardiovascular outcomes may provide a unique opportunity to improve population health.

Validity and Agreement between the 28-Joint Disease Activity Score Based on C-Reactive Protein and Erythrocyte Sedimentation Rate in Patients with Rheumatoid Arthritis

PubMed Central

Nielung, Louise; Christensen, Robin; Danneskiold-Samsøe, Bente; Bliddal, Henning; Holm, Christian Cato; Ellegaard, Karen; Slott Jensen, Hanne; Bartels, Else Marie

2015-01-01

Objective. To validate the agreement between the 28-joint disease activity score based on erythrocyte sedimentation rate (DAS28-ESR) and the 28-joint disease activity score based on C-reactive protein (DAS28-CRP) in a group of Danish patients with rheumatoid arthritis (RA). Methods. Data from 109 Danish RA patients initiating biologic treatment were analysed at baseline and following one year of treatment. Participants were retrospectively enrolled from a previous cohort study and were considered eligible for this project if CRP and ESR were measured at baseline and at the follow-up visit. To assess the extent of agreement between the two DAS28 definitions, the “European League Against Rheumatism” (EULAR) response criteria based on each definition were calculated with cross-classification. Weighted Kappa (κ) coefficients were calculated, and Bland-Altman plots were used to illustrate degree of agreement between DAS28 definitions. Results. The 75 eligible patients were classified as EULAR good, moderate, and nonresponders with good agreement (61/75; 81%) between DAS28-CRP and DAS28-ESR (κ = 0.75 (95% CI: 0.63 to 0.88)). Conclusions. According to our findings, DAS28-CRP and DAS28-ESR are interchangeable when assessing RA patients and the two versions of DAS28 are comparable between studies. PMID:25632353

Feasibility of implementing molecular-guided therapy for the treatment of patients with relapsed or refractory neuroblastoma

PubMed Central

Saulnier Sholler, Giselle L; Bond, Jeffrey P; Bergendahl, Genevieve; Dutta, Akshita; Dragon, Julie; Neville, Kathleen; Ferguson, William; Roberts, William; Eslin, Don; Kraveka, Jacqueline; Kaplan, Joel; Mitchell, Deanna; Parikh, Nehal; Merchant, Melinda; Ashikaga, Takamaru; Hanna, Gina; Lescault, Pamela Jean; Siniard, Ashley; Corneveaux, Jason; Huentelman, Matthew; Trent, Jeffrey

2015-01-01

The primary objective of the study was to evaluate the feasibility and safety of a process which would utilize genome-wide expression data from tumor biopsies to support individualized treatment decisions. Current treatment options for recurrent neuroblastoma are limited and ineffective, with a survival rate of <10%. Molecular profiling may provide data which will enable the practitioner to select the most appropriate therapeutic option for individual patients, thus improving outcomes. Sixteen patients with neuroblastoma were enrolled of which fourteen were eligible for this study. Feasibility was defined as completion of tumor biopsy, pathological evaluation, RNA quality control, gene expression profiling, bioinformatics analysis, generation of a drug prediction report, molecular tumor board yielding a treatment plan, independent medical monitor review, and treatment initiation within a 21 day period. All eligible biopsies passed histopathology and RNA quality control. Expression profiling by microarray and RNA sequencing were mutually validated. The average time from biopsy to report generation was 5.9 days and from biopsy to initiation of treatment was 12.4 days. No serious adverse events were observed and all adverse events were expected. Clinical benefit was seen in 64% of patients as stabilization of disease for at least one cycle of therapy or partial response. The overall response rate was 7% and the progression free survival was 59 days. This study demonstrates the feasibility and safety of performing real-time genomic profiling to guide treatment decision making for pediatric neuroblastoma patients. PMID:25720842

Sentinel node mapping for gastric cancer: a prospective multicenter trial in Japan.

PubMed

Kitagawa, Yuko; Takeuchi, Hiroya; Takagi, Yu; Natsugoe, Shoji; Terashima, Masanori; Murakami, Nozomu; Fujimura, Takashi; Tsujimoto, Hironori; Hayashi, Hideki; Yoshimizu, Nobunari; Takagane, Akinori; Mohri, Yasuhiko; Nabeshima, Kazuhito; Uenosono, Yoshikazu; Kinami, Shinichi; Sakamoto, Junichi; Morita, Satoshi; Aikou, Takashi; Miwa, Koichi; Kitajima, Masaki

2013-10-10

Complicated gastric lymphatic drainage potentially undermines the utility of sentinel node (SN) biopsy in patients with gastric cancer. Encouraged by several favorable single-institution reports, we conducted a multicenter, single-arm, phase II study of SN mapping that used a standardized dual tracer endoscopic injection technique. Patients with previously untreated cT1 or cT2 gastric adenocarcinomas < 4 cm in gross diameter were eligible for inclusion in this study. SN mapping was performed by using a standardized dual tracer endoscopic injection technique. Following biopsy of the identified SNs, mandatory comprehensive D2 or modified D2 gastrectomy was performed according to current Japanese Gastric Cancer Association guidelines. Among 433 patients who gave preoperative consent, 397 were deemed eligible on the basis of surgical findings. SN biopsy was performed in all patients, and the SN detection rate was 97.5% (387 of 397). Of 57 patients with lymph node metastasis by conventional hematoxylin and eosin staining, 93% (53 of 57) had positive SNs, and the accuracy of nodal evaluation for metastasis was 99% (383 of 387). Only four false-negative SN biopsies were observed, and pathologic analysis revealed that three of those biopsies were pT2 or tumors > 4 cm. We observed no serious adverse effects related to endoscopic tracer injection or the SN mapping procedure. The endoscopic dual tracer method for SN biopsy was confirmed as safe and effective when applied to the superficial, relatively small gastric adenocarcinomas included in this study.

78 FR 15541 - Patient Protection and Affordable Care Act; Amendments to the HHS Notice of Benefit and Payment...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-11

... regulatory approach for de minimis variation standards, silver plan variations for individuals eligible for... structure in the applicable plan variation for which the individual is eligible. Under the second... Davies, Cathy D. Sherbourne, George A. Goldberg, Kathleen N. Lohr, Patricia Camp and Joseph P. Newhouse...

Treatment influencing down-staging in EORTC Melanoma Group sentinel node histological protocol compared with complete step-sectioning: a national multicentre study.

PubMed

Riber-Hansen, Rikke; Hastrup, Nina; Clemmensen, Ole; Behrendt, Nille; Klausen, Siri; Ramsing, Mette; Spaun, Eva; Hamilton-Dutoit, Stephen Jacques; Steiniche, Torben

2012-02-01

Metastasis size in melanoma sentinel lymph nodes (SLNs) is an emerging prognostic factor. Two European melanoma treatment trials include SLN metastasis diameters as inclusion criteria. Whilst diameter estimates are sensitive to the number of sections examined, the level of this bias is largely unknown. We performed a prospective multicentre study to compare the European Organisation for Research and Treatment of Cancer (EORTC) recommended protocol with a protocol of complete step-sectioning. One hundred and thirty-three consecutive SLNs from seven SLN centres were analysed by five central sections 50μm apart (EORTC Protocol) followed by complete 250μm step-sectioning. Overall, 29 patients (21.8%) were SLN-positive. The EORTC Protocol missed eight of these metastases (28%), one metastasis measuring less than 0.1mm in diameter, seven measuring between 0.1 and 1mm. Complete step-sectioning at 250μm intervals (Extensive Protocol) missed one metastasis (3%) that measured less than 0.1mm. Thirteen treatment courses (34%) performed if inclusion was based on the Combined Protocol would not be performed if assessed by the EORTC Protocol. Thus, 10 patients would be without completion lymph node dissection (EORTC MINITUB study), whilst three patients would not be eligible for anti-CTLA4 trial (EORTC protocol 18071). The corresponding number with the Extensive Protocol would be three; one patient for the MINITUB registration study and two patients for the anti-CTLA4 study. Examining SLNs by close central sectioning alone (EORTC Protocol) misses a substantial number of metastases and underestimates the maximum metastasis diameter, leading to important changes in patient eligibility for various treatment protocols. Copyright © 2011 Elsevier Ltd. All rights reserved.

78 FR 54472 - Proposed Data Collections Submitted for Public Comment and Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-04

... questions to take about 5 minutes and the telephone interview 30 minutes per respondent in both the adult...-patients) will be contacted for the CDI study interview annually. Of those, 71 will agree and be eligible to participate in the study and will proceed to the full telephone interview. A total of 142 persons...

An emergency department registration kiosk can increase HIV screening in high risk patients.

PubMed

Hsieh, Yu-Hsiang; Gauvey-Kern, Megan; Peterson, Stephen; Woodfield, Alonzo; Deruggiero, Katherine; Gaydos, Charlotte A; Rothman, Richard E

2014-12-01

We evaluated the feasibility and the patient acceptability of integrating a kiosk into routine emergency department (ED) practice for offering HIV testing. The work was conducted in four phases: phase 1 was a baseline, in which external testing staff offered testing at the bedside; phase 2 was a pilot assessment of a prototype kiosk; phase 3 was a pilot implementation and phase 4 was the full implementation with automated login. Feasibility was assessed by the proportion of offering HIV tests, acceptance, completion and result reporting. During the study period, the number of ED patients and eligible patients for screening were similar in the three main phases. However, the number and proportion of patients offered testing of those eligible for screening increased significantly from phase 1 (32%) to phase 3 (37%) and phase 4 (40%). There were slightly higher prevalences of newly diagnosed HIV with kiosk versus bedside testing (phase 1, 0%; phase 3, 0.2%; phase 4, 0.5%). Compared to patients tested at the bedside, patients tested via the kiosk were significantly younger, more likely to be female, to be black, and to report high risk behaviours. ED-based HIV screening via a registration-based kiosk was feasible, yielded similar proportions of testing, and increased the proportion of engagement of higher-risk patients in testing. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Statistical Process Control: A Quality Tool for a Venous Thromboembolic Disease Registry.

PubMed

Posadas-Martinez, Maria Lourdes; Rojas, Liliana Paloma; Vazquez, Fernando Javier; De Quiros, Fernan Bernaldo; Waisman, Gabriel Dario; Giunta, Diego Hernan

2016-01-01

We aim to describe Statistical Control Process as a quality tool for the Institutional Registry of Venous Thromboembolic Disease (IRTD), a registry developed in a community-care tertiary hospital in Buenos Aires, Argentina. The IRTD is a prospective cohort. The process of data acquisition began with the creation of a computerized alert generated whenever physicians requested imaging or laboratory study to diagnose venous thromboembolism, which defined eligible patients. The process then followed a structured methodology for patient's inclusion, evaluation, and posterior data entry. To control this process, process performance indicators were designed to be measured monthly. These included the number of eligible patients, the number of included patients, median time to patient's evaluation, and percentage of patients lost to evaluation. Control charts were graphed for each indicator. The registry was evaluated in 93 months, where 25,757 patients were reported and 6,798 patients met inclusion criteria. The median time to evaluation was 20 hours (SD, 12) and 7.7% of the total was lost to evaluation. Each indicator presented trends over time, caused by structural changes and improvement cycles, and therefore the central limit suffered inflexions. Statistical process control through process performance indicators allowed us to control the performance of the registry over time to detect systematic problems. We postulate that this approach could be reproduced for other clinical registries.

Can patient navigation improve receipt of recommended breast cancer care? Evidence from the National Patient Navigation Research Program.

PubMed

Ko, Naomi Y; Darnell, Julie S; Calhoun, Elizabeth; Freund, Karen M; Wells, Kristin J; Shapiro, Charles L; Dudley, Donald J; Patierno, Steven R; Fiscella, Kevin; Raich, Peter; Battaglia, Tracy A

2014-09-01

Poor and underserved women face barriers in receiving timely and appropriate breast cancer care. Patient navigators help individuals overcome these barriers, but little is known about whether patient navigation improves quality of care. The purpose of this study is to examine whether navigated women with breast cancer are more likely to receive recommended standard breast cancer care. Women with breast cancer who participated in the national Patient Navigation Research Program were examined to determine whether the care they received included the following: initiation of antiestrogen therapy in patients with hormone receptor-positive breast cancer; initiation of postlumpectomy radiation therapy; and initiation of chemotherapy in women younger than age 70 years with triple-negative tumors more than 1 cm. This is a secondary analysis of a multicenter quasi-experimental study funded by the National Cancer Institute to evaluate patient navigation. Multiple logistic regression was performed to compare differences in receipt of care between navigated and non-navigated participants. Among participants eligible for antiestrogen therapy, navigated participants (n = 380) had a statistically significant higher likelihood of receiving antiestrogen therapy compared with non-navigated controls (n = 381; odds ratio [OR], 1.73; P = .004) in a multivariable analysis. Among the participants eligible for radiation therapy after lumpectomy, navigated participants (n = 255) were no more likely to receive radiation (OR, 1.42; P = .22) than control participants (n = 297). We demonstrate that navigated participants were more likely than non-navigated participants to receive antiestrogen therapy. Future studies are required to determine the full impact patient navigation may have on ensuring that vulnerable populations receive quality care. © 2014 by American Society of Clinical Oncology.

Temsirolimus in women with platinum-refractory/resistant ovarian cancer or advanced/recurrent endometrial carcinoma. A phase II study of the AGO-study group (AGO-GYN8).

PubMed

Emons, Günter; Kurzeder, Christian; Schmalfeldt, Barbara; Neuser, Petra; de Gregorio, Nikolaus; Pfisterer, Jacobus; Park-Simon, Tjoung-Won; Mahner, Sven; Schröder, Willibald; Lück, Hans-Joachim; Heubner, Martin Leonhard; Hanker, Lars; Thiel, Falk; Hilpert, Felix

2016-03-01

To evaluate activity and toxicity of mTOR inhibitor temsirolimus in patients with platinum-refractory/resistant ovarian cancer (OC) or advanced/recurrent endometrial carcinoma (EC). Women with epithelial ovarian, fallopian tube or primary peritoneal cancer were eligible, when they had progression during treatment with a platinum based regimen or within 6 months after receiving a platinum based regimen and a previous taxane treatment. Women with advanced/recurrent EC, no longer amenable to curative surgery and/or radiotherapy were eligible when they had no previous or only adjuvant chemotherapy. Preceding endocrine therapy for metastatic/recurrent disease was allowed. Patients received weekly IV infusions of 25mg temsirolimus. Primary endpoint was progression free survival rate after 4 months (OC) or 6 months (EC). A two stage design was applied. Forty-four patients (OC: n=22; EC: n=22) were enrolled and received temsirolimus treatment. Median age was 56 years (OC) or 63 years (EC). After eight weeks of treatment, 10 of 21 evaluable patients in the OC cohort and 8 of 20 evaluable patients in the EC cohort had progressive disease. Thus efficacy did not meet the predefined levels during the first stage of recruitment and the trial was stopped. Some patients in both cohorts had long lasting PFS (>7 months). Toxicity of temsirolimus was mild. Temsirolimus treatment was well tolerated in our patients, but did not meet the predefined efficacy criteria. In our study as in other trials on rapalogs in OC or EC, a few patients had long lasting disease stabilisations. Copyright © 2015. Published by Elsevier Inc.

Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review.

PubMed

Schenker, Yael; Fernandez, Alicia; Sudore, Rebecca; Schillinger, Dean

2011-01-01

Patient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent. . To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources. A systematic literature search of English-language articles in MEDLINE (1949-2008) and EMBASE (1974-2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection. Randomized controlled trials and controlled trials with nonrandom allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction. Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis. Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations. Many studies failed to include adequate description of the study population, and outcome measures varied widely. . A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations.

Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: A Systematic Review

PubMed Central

Schenker, Yael; Fernandez, Alicia; Sudore, Rebecca; Schillinger, Dean

2017-01-01

Background Patient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent. Purpose To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources A systematic literature search of English-language articles in MEDLINE (1949–2008) and EMBASE (1974–2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection Randomized controlled trials and controlled trials with non-random allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations Many studies failed to include adequate description of the study population, and outcome measures varied widely. Conclusions A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations. PMID:20357225

Race, treatment preferences, and hospice enrollment. Eligibility criteria may exclude patients with the greatest needs for care

PubMed Central

Fishman, Jessica; O'Dwyer, Peter; Lu, Hien L.; Henderson, Hope; Asch, David A.; Casarett, David J.

2009-01-01

Background The requirement that patients give up curative treatment makes hospice enrollment unappealing for some patients, and may particularly limit use among African American patients. Objectives To determine whether African-American patients with cancer are more likely than white patients are to have preferences for cancer treatment that exclude them from hospice, and whether they are less likely to want specific hospice services. Methods 283 patients receiving treatment for cancer at six oncology clinics within the University of Pennsylvania Cancer Network completed conjoint interviews measuring their perceived need for five hospice services and their preferences for continuing cancer treatment. Patients were followed for six months or until death. Results African American patients had stronger preferences for continuing their cancer treatments on a 7-point scale even after adjusting for age, sex, finances, education, ECOG performance status, quality of life, and physical and psychological symptom burden (adjusted means 4.75 vs. 3.96; β coefficient 0.82; 95% confidence interval 0.22-1.41; p=0.007). African-American patients also had greater perceived needs for hospice services after adjusting for these characteristics (adjusted means 2.31 vs. 1.83) (β coefficient 0.51; 95% confidence interval 0.11-0.92; p=0.01). However, this effect disappeared after adjusting for household finances. Conclusions Hospice eligibility criteria may exclude African-American patients disproportionately despite greater perceived needs for hospice services in this population. The mechanisms driving this health disparity likely include both cultural differences and economic characteristics, and consideration should be given to redesigning hospice eligibility criteria. PMID:19107761

The impact of stem cell transplantation on the natural course of peripheral T-cell lymphoma: a real-world experience.

PubMed

Rohlfing, Sarah; Dietrich, Sascha; Witzens-Harig, Mathias; Hegenbart, Ute; Schönland, Stefan; Luft, Thomas; Ho, Anthony D; Dreger, Peter

2018-07-01

The role of autologous stem cell transplantation (autoSCT) as consolidating treatment for peripheral T-cell lymphoma (PTCL) is unsettled. The aim of this analysis was to investigate the impact of autoSCT in the upfront setting by intent-to-treat and to study salvage strategies after relapse. Retrospective follow-up of all patients aged 18-70 years and treated at our institution for ALK-PTCL diagnosed between 2001 and 2014. Of 117 eligible patients, diagnosis was PTCL-NOS in 34, ALCL ALK- in 31, AITL in 28, and other PTCL in 24 patients. Disregarding 20 patients who received first-line treatment externally, upfront autoSCT was not intended in 34 due to comorbidity, higher age, low IPI, physician's decision or unknown reasons (nITT), while intent-to-transplant (ITT) was documented in 63 patients. ITT was not associated with significant benefits for 5-year progression-free survival (PFS) and overall survival (OS) with 46 and 23% in the ITT group vs. 42 and 25% in the nITT group, even after multivariate adjustment for confounders. Altogether, 91 of all 117 patients relapsed or progressed. Thirty-one patients managed to proceed to salvage allografting and achieved a 5-year OS of 52%. In contrast, all 7 patients receiving salvage autoSCT relapsed and died, and only 3 of the 51 patients not eligible for SCT salvage survived. In this study, a significant benefit of intending first-line autoSCT over non-transplant induction in patients with ALK-PTCL did not emerge. Most patients fail first-line treatment and have a poor outlook if salvage alloSCT cannot be performed.

Human Papillomavirus vaccination in general practice in France, three years after the implementation of a targeted vaccine recommendation based on age and sexual history.

PubMed

Thierry, Pascale; Lasserre, Andrea; Rossignol, Louise; Kernéis, Solen; Blaizeau, Fanette; Stheneur, Chantal; Blanchon, Thierry; Levy-Bruhl, Daniel; Hanslik, Thomas

2016-01-01

In France, vaccination against human papilloma virus (HPV) was recommended in 2007 for all 14-year-old girls as well as "catch-up" vaccination for girls between 15-23 y of age either before or within one year of becoming sexually active. We evaluated the vaccine coverage according to the eligibility for vaccination in a sample of young girls aged 14 to 23 years, who were seen in general practices. A survey was proposed to 706 general practitioners (GPs) and carried out from July to September 2010. GPs, also called "family doctor," are physicians whose practice is not restricted to a specific field of medicine but instead covers a variety of medical problems in patients of all ages. Each participating GP included, retrospectively, the last female patient aged 14-17 y and the last female patient aged 18-23 y whom he had seen. A questionnaire collected information regarding the GP and the patients' characteristics. The vaccine coverage was determined according to the eligibility for vaccination, i.e. the coverage among younger women (14-17) and among those sexually active in the second age range (18-23). Sexual activity status was assessed by GP, according to information stated in the medical record. The 363 participating physicians (response rate 51.4%) included 712 patients (357 in the 14- to 17-year-old group and 355 in the 15- to 23-year-old group) in their responses. The rate of the vaccination coverage in the 14- to 17-year-old group was 55%. Among the girls in the 18- to 23-year-old group, 126 were eligible, and their vaccination coverage rate was 82%. The evaluation of the eligibility by the GPs was incorrect in 36% of the cases. Of the 712 patients, 6% of the girls had been vaccinated without a need for the vaccination, and 26% of the girls had not been vaccinated, although they needed to be vaccinated. Regarding the vaccine uptake, vaccination at the age of 14 was not as effective as vaccinating the older population for which vaccination was indicated as a catch-up program, based on sexual history. However, in more than one-third of the older population, difficulties remained regarding the determination of eligibility, according to the sexual history of the patient.

Transcutaneous electric nerve stimulation (TENS) for cancer pain in adults.

PubMed

Robb, Karen A; Bennett, Michael I; Johnson, Mark I; Simpson, Karen J; Oxberry, Stephen G

2008-07-16

Cancer-related pain is complex and multi-dimensional but the mainstay of cancer pain management has predominately used a biomedical approach. There is a need for non-pharmacological and innovative approaches. Transcutaneous Electric Nerve Stimulation (TENS) may have a role for a significant number of patients but the effectiveness of TENS is currently unknown. The aim of this systematic review was to determine the effectiveness of TENS for cancer-related pain in adults. We searched The Cochrane Library, MEDLINE, EMBASE, CINAHL, PsychINFO, AMED and PEDRO databases (11/04/08). Only randomised controlled trials (RCTS) investigating the use of TENS for the management of cancer-related pain in adults were included. The search strategy identified 37 possible published studies which were divided between two pairs of review authors that decided on study selection. A study eligibility form was used to screen each abstract and where study eligibility could not be determined from the abstract, the full paper was obtained and assessed by one pair of review authors. A standardised data extraction sheet was used to collect information on the studies and the quality of the studies was assessed independently by two review authors using the validated five-point Oxford Quality Scale. Final scores were discussed and agreed between all four review authors. The small sample sizes and differences in patient study populations of the two included studies prevented meta-analysis. Only two RCTs met the eligibility criteria (64 participants). These studies were heterogenous with respect to study population, sample size, study design, methodological quality, mode of TENS, treatment duration, method of administration and outcome measures used. In one RCT, there were no significant differences between TENS and placebo in women with chronic pain secondary to breast cancer treatment. In the other RCT, there were no significant differences between acupuncture-type TENS and sham in palliative care patients; this study was underpowered. The results of this systematic review are inconclusive due to a lack of suitable RCTs. Large multi-centre RCTs are required to assess the value of TENS in the management of cancer-related pain in adults.

BTS randomised feasibility study of active symptom control with or without chemotherapy in malignant pleural mesothelioma: ISRCTN 54469112.

PubMed

Muers, M F; Rudd, R M; O'Brien, M E R; Qian, W; Hodson, A; Parmar, M K B; Girling, D J

2004-02-01

The incidence of mesothelioma is rising rapidly in the UK. There is no generally accepted standard treatment. The BTS recommends active symptom control (ASC). It is not known whether chemotherapy in addition prolongs survival or provides worthwhile palliation with acceptable toxicity. Palliation as recorded by patients has been fully reported for only two regimens: mitomycin, vinblastine, and cisplatin (MVP), and vinorelbine (N). The BTS and collaborators planned to conduct a phase III randomised trial comparing ASC only, ASC+MVP, and ASC+N in 840 patients with survival as the primary outcome measure. The aim of the present study was to assess the acceptability of the trial design to patients and the suitability of two standard quality of life (QL) questionnaires for mesothelioma. Collaborating centres registered all new patients with mesothelioma. Those eligible and giving informed consent completed EORTC QLQ-C30+LC13 and FACT-L QL questionnaires and were randomised between all three or any two of (1) ASC only, (2) ASC+4 cycles of MVP, and (3) ASC+12 weekly doses of N. During 1 year, 242 patients were registered of whom 109 (45%) were randomised (55% of the 197 eligible patients). Fifty two patients from 20 centres were randomised to an option including ASC only. This translates into a rate of 312 per year from 60 centres interested in collaborating in the phase III trial. The EORTC QL questionnaire was superior to FACT-L in terms of completeness of data and patient preference. Clinically relevant palliation was achieved with ASC. The planned phase III trial is feasible.

Maintenance of parenteral nutrition volume reduction, without weight loss, after stopping teduglutide in a subset of patients with short bowel syndrome.

PubMed

Compher, Charlene; Gilroy, Richard; Pertkiewicz, Marek; Ziegler, Thomas R; Ratcliffe, Sarah J; Joly, Francisca; Rochling, Fedja; Messing, Bernard

2011-09-01

Teduglutide was discontinued after being tested for ≥ 24 weeks in patients with parenteral nutrition (PN) -dependent short bowel syndrome in a clinical trial for efficacy to reduce PN volume. This study was describes change in body mass index (BMI) and PN volume over 12 months in patients who stopped drug after the clinical trial. Prescribed PN volume, weight, and complications were reported. Patients with stable (NEUT, n = 15) or decreased (DEC, n = 7) PN volume by 12 months after stopping drug (NEUT/DEC, n = 22) were compared to those who had increased PN volume (INC, n = 15). With drug response defined by ≥ 20% reduction from pre-drug PN volume to end of drug therapy, 12 INC and 13 NEUT/DEC patients were drug responders. Eleven of 20 eligible sites reported data for 39 of 53 eligible study participants, with follow-up data for 37. INC patients had shorter colon and less frequently had colon in continuity than NEUT/DEC. BMI was decreased at 3, 6, and 12 months relative to the first off-drug visit in INC patients (P = .001), but not in NEUT/DEC patients. Change in BMI off-drug was predicted by colon and small bowel length, baseline BMI, and on-drug change in PN volume (adjusted R2 = 0.708). Gastrointestinal anatomy, baseline BMI, and PN volume reduction on-drug predicted change in BMI off-drug. Whether this response would be maintained for a longer time or in the context of a challenging clinical situation has not been evaluated.

Helicobacter pylori eradication and histopathological esophagitis in dyspeptic patients.

PubMed

Amini, Mohsen; Karbasi, Ashraf; Khedmat, Hossein; Jeihounian, Mojgan

2010-01-01

The association of Helicobacterpylori with peptic ulcer disease, atrophic gastritis, gastric adenocarcinoma, MALT (mucosa associated lymphoid tissue) lymphoma is well recognized. This study was conducted to see whether there was any relation between H. pylori eradication and reflux esophagitis in Iran. Eligible dyspeptic patients referred to Gastroenterology clinic in Baqiyatollah hospital were endoscopied and evaluated for endoscopic and pathologic esophagitis and the H. pylori infection status was determined by rapid urease test. H. pylori infection was treated by an anti H. pylori drug regimen and successfully eradicated patients according to negative C14 urea breath test were followed and re-endoscopy was performed 6-9 months after the end of treatment. From 175 eligible patients, 54% were H. pylori positive, 68 of them (72%) had successful H.P. eradication and 64 patients completed the follow-up. The rate of histopathologic inflammatory esophagitis was higher in second endoscopy, compared with that of first endoscopy, i.e., before H. pylori eradication (75% vs 40.6%) (p < 0.05). Progression of pathological esophagitis was seen in 56.3% of patients between the two endoscopic evaluations in spite of no change in clinical and endoscopic findings. There were no significant differences in dietary and smoking habits and body weights on re-endoscopy session compared with that of the first endoscopy visit (p > 0.05). This study suggests that H. pylori eradication in dyspeptic patients may lead to increased frequency of histopathological esophagitis. Hence, In patients presenting with symptoms of dyspepsia, a cautious approach should be exercised if H. pylori eradication is being contemplated.

Management of adult patients with persistent idiopathic thrombocytopenic purpura following splenectomy: a systematic review.

PubMed

Vesely, Sara K; Perdue, Jedidiah J; Rizvi, Mujahid A; Terrell, Deirdra R; George, James N

2004-01-20

Treatment of chronic refractory idiopathic thrombocytopenic purpura is a dilemma because many patients have minimal symptoms, response to treatment is uncertain, and treatments may have serious adverse effects. To determine the effectiveness of treatments for adult patients with idiopathic thrombocytopenic purpura who have not responded to splenectomy. English-language reports from 1966 through 2003 that were retrieved from MEDLINE and Reference Update and bibliographies of retrieved articles. Articles reporting 5 or more total patients were reviewed to select eligible patients. Patients were eligible for inclusion if they were more than 16 years of age, had idiopathic thrombocytopenic purpura for more than 3 months, had a previous splenectomy, and had a platelet count less than 50 x 10(9) cells/L. Patients were assessed for platelet count response, bleeding complications, duration of follow-up, and death. Complete remission was defined as a normal platelet count with no treatment for more than 3 months and for the duration of follow-up. 90 articles with 656 patients treated with 22 therapies met selection criteria. Azathioprine, cyclophosphamide, and rituximab had the most reported complete responses, but they were reported in only 41 to 109 patients. Reported complete response rates ranged from 17% to 27%, but 36% to 42% of patients had no response with these 3 treatments. Most reports described only platelet count responses; bleeding outcomes were reported in only 63 patients (10%). Only 111 (17%) of the 656 eligible patients had pretreatment platelet counts of less than 10 x 10(9) cells/L. No treatment method was reported in more than 20 patients. Evidence for the effectiveness of any treatment for patients with idiopathic thrombocytopenic purpura and persistent severe thrombocytopenia after splenectomy is minimal. Potentially effective treatments must be evaluated by randomized, controlled trials to determine both benefit and safety.

Early Discharge in Low-Risk Patients Hospitalized for Acute Coronary Syndromes: Feasibility, Safety and Reasons for Prolonged Length of Stay.

PubMed

Laurencet, Marie-Eva; Girardin, François; Rigamonti, Fabio; Bevand, Anne; Meyer, Philippe; Carballo, David; Roffi, Marco; Noble, Stéphane; Mach, François; Gencer, Baris

2016-01-01

Length of hospital stay (LHS) is an indicator of clinical effectiveness. Early hospital discharge (≤72 hours) is recommended in patients with acute coronary syndromes (ACS) at low risk of complications, but reasons for prolonged LHS poorly reported. We collected data of ACS patients hospitalized at the Geneva University Hospitals from 1st July 2013 to 30th June 2015 and used the Zwolle index score to identify patients at low risk (≤ 3 points). We assessed the proportion of eligible patients who were successfully discharged within 72 hours and the reasons for prolonged LHS. Outcomes were defined as adherence to recommended therapies, major adverse events at 30 days and patients' satisfaction using a Likert-scale patient-reported questionnaire. Among 370 patients with ACS, 255 (68.9%) were at low-risk of complications but only 128 (50.2%)were eligible for early discharge, because of other clinical reasons for prolonged LHS (e.g. staged coronary revascularization, cardiac monitoring) in 127 patients (49.8%). Of the latter, only 45 (35.2%) benefitted from an early discharge. Reasons for delay in discharge in the remaining 83 patients (51.2%) were mainly due to delays in additional investigations, titration of medical therapy, admission or discharge during weekends. In the early discharge group, at 30 days, only one patient (2.2%) had an adverse event (minor bleeding), 97% of patients were satisfied by the medical care. Early discharge was successfully achieved in one third of eligible ACS patients at low risk of complications and appeared sufficiently safe while being overall appreciated by the patients.

Design, recruitment outcomes, and sample characteristics of the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial.

PubMed

Krebs, Erin E; Jensen, Agnes C; Nugent, Sean; DeRonne, Beth; Rutks, Indulis; Leverty, David; Gravely, Amy; Noorbaloochi, Siamak; Bair, Matthew J; Kroenke, Kurt

2017-11-01

This manuscript describes the study protocol, recruitment outcomes, and baseline participant characteristics for the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial. SPACE is a pragmatic randomized comparative effectiveness trial conducted in multiple VA primary care clinics within one VA health care system. The objective was to compare benefits and harms of opioid therapy versus non-opioid medication therapy over 12months among patients with moderate-to-severe chronic back pain or hip/knee osteoarthritis pain despite analgesic therapy; patients already receiving regular opioid therapy were excluded. Key design features include comparing two clinically-relevant medication interventions, pragmatic eligibility criteria, and flexible treat-to-target interventions. Screening, recruitment and study enrollment were conducted over 31months. A total of 4491 patients were contacted for eligibility screening; 53.1% were ineligible, 41.0% refused, and 5.9% enrolled. The most common reasons for ineligibility were not meeting pain location and severity criteria. The most common study-specific reasons for refusal were preference for no opioid use and preference for no pain medications. Of 265 enrolled patients, 25 withdrew before randomization. Of 240 randomized patients, 87.9% were male, 84.1% were white, and age range was 21-80years. Past-year mental health diagnoses were 28.3% depression, 17% anxiety, 9.4% PTSD, 7.9% alcohol use disorder, and 2.6% drug use disorder. In conclusion, although recruitment for this trial was challenging, characteristics of enrolled participants suggest we were successful in recruiting patients similar to those prescribed opioid therapy in usual care. Published by Elsevier Inc.

A multicenter phase II study of salvage photodynamic therapy using talaporfin sodium (ME2906) and a diode laser (PNL6405EPG) for local failure after chemoradiotherapy or radiotherapy for esophageal cancer

PubMed Central

Yano, Tomonori; Kasai, Hiroi; Horimatsu, Takahiro; Yoshimura, Kenichi; Teramukai, Satoshi; Morita, Satoshi; Tada, Harue; Yamamoto, Yoshinobu; Kataoka, Hiromi; Kakushima, Naomi; Ishihara, Ryu; Isomoto, Hajime; Muto, Manabu

2017-01-01

Photodynamic therapy (PDT) showed promising efficacy for local failure after chemoradiotherapy (CRT) for esophageal cancer. However, PDT required long sun shade period. This study aimed to evaluate the safety and efficacy of PDT using second generation photosensitizer, talaporfin sodium for local failure after CRT. This was the multi-institutional non-randomized phase II study. Patients with histologically proven local failure limited within the muscularis propria after 50Gy or more radiotherapy (RT) for esophageal cancer were eligible. We set the primary endpoint as local complete response (L-CR) per patients. And, secondary endpoints were confirmed L-CR, local progression free survival (L-PFS), progression free survival (PFS), overall survival (OS), L-CR per lesions (Lesion L-CR), and confirmed Lesion L-CR. The PDT procedure commenced with intravenous administration of a 40 mg/m2 dose of talaporfin sodium followed by diode laser irradiation at a 664 nm wavelength. 26 eligible patients were enrolled and all were treated with PDT. Twenty three patients with 25 lesions were assessed L-CR after PDT; the L-CR rate per patients was 88.5% (95% CI: 69.8%-97.6%). No skin phototoxicity was observed, and no grade 3 or worse non-hematological toxicities related to PDT were observed. PDT using talaporfin sodium and a diode laser is a safe and curative salvage treatment for local failure after CRT or RT for patients with esophageal cancer. PMID:28212527

Stigma-related experiences in non-communicable respiratory diseases: A systematic review.

PubMed

Rose, Shiho; Paul, Christine; Boyes, Allison; Kelly, Brian; Roach, Della

2017-08-01

The stigma of non-communicable respiratory diseases (NCRDs), whether perceived or otherwise, can be an important element of a patient's experience of his/her illness and a contributing factor to poor psychosocial, treatment and clinical outcomes. This systematic review examines the evidence regarding the associations between stigma-related experiences and patient outcomes, comparing findings across a range of common NCRDs. Electronic databases and manual searches were conducted to identify original quantitative research published to December 2015. Articles focussing on adult patient samples diagnosed with asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, lung cancer or mesothelioma, and included a measurement of stigma-related experience (i.e. perceived stigma, shame, blame or guilt), were eligible for inclusion. Included articles were described for study characteristics, outcome scores, correlates between stigma-related experiences and patient outcomes and methodological rigor. Twenty-five articles were eligible for this review, with most ( n = 20) related to lung cancer. No articles for cystic fibrosis were identified. Twenty unique scales were used, with low to moderate stigma-related experiences reported overall. The stigma-related experiences significantly correlated with all six patient-related domains explored (psychosocial, quality of life, behavioral, physical, treatment and work), which were investigated more widely in COPD and lung cancer samples. No studies adequately met all criteria for methodological rigor. The inter-connectedness of stigma-related experiences to other aspects of patient experiences highlight that an integrated approach is needed to address this important issue. Future studies should adopt more rigorous methodology, including streamlining measures, to provide robust evidence.

Potential and Actual Neonatal Organ and Tissue Donation After Circulatory Determination of Death.

PubMed

Stiers, Justin; Aguayo, Cecile; Siatta, Angela; Presson, Angela P; Perez, Richard; DiGeronimo, Robert

2015-07-01

The need for transplants continues to exceed organ and tissue donor availability. Although recent surgical advances have resulted in successful transplants using very small pediatric donors, including neonates, the actual practice of neonatal organ donation after circulatory determination of death (DCDD) remains uncommon. To describe the percentage of neonates potentially eligible for DCDD, including those who underwent successful donation, and reasons for ineligibility in those who did not in a single neonatal intensive care unit (NICU). We obtained data from the Children's Hospital Neonatal Database and Intermountain Donor Services (IDS) organ procurement records. The 136 deaths that occurred in the NICU of the Primary Children's Hospital, Salt Lake City, Utah, from January 1, 2010, through May 7, 2013, were reviewed retrospectively from January 12 through July 1, 2014, to determine potential eligibility for DCDD as determined by IDS minimum eligibility criteria (requirement of life-sustaining interventions and weight >2 kg). For patients who did not undergo DCDD, we reviewed records to determine the reasons for ineligibility. Potential eligibility for DCDD among neonates who died in the study NICU. Of 136 deaths in the NICU, 60 (44.1%) met criteria for DCDD; however, fewer than 10% were referred appropriately to the regional organ procurement organization for evaluation. Forty-five neonates (33.1%) ultimately died within 90 minutes of withdrawal of life-sustaining interventions and thus would have been eligible for organ donation based on warm ischemic time. The most common causes of death among the 60 potentially eligible neonatal donors were neonatal encephalopathy (n = 17) and multiple congenital anomalies (n = 14). Nonreferral or late referral by the medical team was the most frequent reason for donor ineligibility, including 49 neonates (36.0%). Overall, only 4 neonates (2.9%) underwent successful DCDD. Although almost half of all neonatal deaths identified met minimum IDS criteria, most of these patients were not referred or were referred too late for evaluation. Although small size remains the primary reason for exclusion from DCDD, improved education with regard to criteria and the importance of timely referral by neonatologists and other members of the NICU team would likely result in a significant increase of future donations.

Patient Protection and Affordable Care Act; program integrity: Exchange, SHOP, and eligibility appeals. Final rule.

PubMed

2013-08-30

This final rule implements provisions of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act). Specifically, this final rule outlines Exchange standards with respect to eligibility appeals, agents and brokers, privacy and security, issuer direct enrollment, and the handling of consumer cases. It also sets forth standards with respect to a State's operation of the Exchange and Small Business Health Options Program (SHOP). It generally is finalizing previously proposed policies without change.

21 CFR 312.42 - Clinical holds and requests for modification.

Code of Federal Regulations, 2013 CFR

2013-04-01

... unless specifically permitted by FDA in the interest of patient safety. (b) Grounds for imposition of... a life-threatening disease or condition that affects both genders, and men or women with reproductive potential who have the disease or condition being studied are excluded from eligibility because of...

21 CFR 312.42 - Clinical holds and requests for modification.

Code of Federal Regulations, 2014 CFR

2014-04-01

... unless specifically permitted by FDA in the interest of patient safety. (b) Grounds for imposition of... a life-threatening disease or condition that affects both genders, and men or women with reproductive potential who have the disease or condition being studied are excluded from eligibility because of...

21 CFR 312.42 - Clinical holds and requests for modification.

Code of Federal Regulations, 2012 CFR

2012-04-01

... unless specifically permitted by FDA in the interest of patient safety. (b) Grounds for imposition of... a life-threatening disease or condition that affects both genders, and men or women with reproductive potential who have the disease or condition being studied are excluded from eligibility because of...

A phase II study of sunitinib in patients with recurrent epithelial ovarian and primary peritoneal carcinoma: an NCIC Clinical Trials Group Study.

PubMed

Biagi, J J; Oza, A M; Chalchal, H I; Grimshaw, R; Ellard, S L; Lee, U; Hirte, H; Sederias, J; Ivy, S P; Eisenhauer, E A

2011-02-01

Sunitinib is a multitargeted receptor tyrosine kinase inhibitor. We conducted a two-stage phase II study to evaluate the objective response rate of oral sunitinib in recurrent epithelial ovarian cancer. Eligibility required measurable disease and one or two prior chemotherapies, at least one platinum based. Platinum-sensitive or -resistant disease was allowed. Initial dose schedule was sunitinib 50 mg daily, 4 of 6 weeks. Observation of fluid accumulations during off-treatment periods resulted in adoption of continuous 37.5 mg daily dosing in the second stage of accrual. Of 30 eligible patients, most had serous histology (67%), were platinum sensitive (73%) and had two prior chemotherapies (60%). One partial response (3.3%) and three CA125 responses (10%) were observed, all in platinum-sensitive patients using intermittent dosing. Sixteen (53%) had stable disease. Five had >30% decrease in measurable disease. Overall median progression-free survival was 4.1 months. Common adverse events included fatigue, gastrointestinal symptoms, hand-foot syndrome and hypertension. No gastrointestinal perforation occurred. Single-agent sunitinib has modest activity in recurrent platinum-sensitive ovarian cancer, but only at the 50 mg intermittent dose schedule, suggesting that dose and schedule may be vital considerations in further evaluation of sunitinib in this cancer setting.

Correlation of cetuximab-induced skin rash and outcomes of solid tumor patients treated with cetuximab: a systematic review and meta-analysis.

PubMed

Abdel-Rahman, Omar; Fouad, Mona

2015-02-01

We performed a systematic review and meta-analysis of the correlation between cetuximab-induced skin rash and outcomes of solid tumor patients treated with cetuximab. Eligible studies included phase I, II and III trials of patients with solid tumors on cetuximab; describing events of skin rash and correlating skin rash with overall survival (OS), progression free survival (PFS) and/or overall response rate (ORR). Our search strategy yielded 409 potentially relevant citations on CETUXIMAB from Pubmed/Medline, CENTRAL Cochrane registry and ASCO meeting library. After exclusion of ineligible studies, a total of 13 clinical trials were considered eligible for the meta-analysis, including 4 phase III trials, 8 phase II trials and one phase I trial. The occurrence of cetuximab-induced rash in patients was highly associated with improvements in PFS (HR=0.74; 95% CI: 0.63-0.86, P<0.0002), OS (HR=0.60; 95% CI: 0.47-0.76, P<0.0001), and ORR (RR=1.51, 95% CI: 1.26-1.81, P<0.00001), as compared to patients without rash. Exploratory subgroup analysis showed no effect of tumor types on the RR of ORR. Our meta-analysis has demonstrated that cetuximab-induced rash is associated with a significantly improved OS, PFS and ORR. Cetuximab-induced skin rash may represent a prognostic factor in patients with advanced solid tumors. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Diabetes mellitus and poorer prognosis in hepatocellular carcinoma: a systematic review and meta-analysis.

PubMed

Wang, Yan-Gang; Wang, Peng; Wang, Bin; Fu, Zheng-Ju; Zhao, Wen-Juan; Yan, Sheng-Li

2014-01-01

Previous studies suggested that diabetes mellitus was associated with cancer risk and prognosis, but studies investigating the relationship between diabetes mellitus and survival in patients with hepatocellular carcinoma (HCC) reported inconsistent findings. To derive a more precise estimate of the prognostic role of diabetes mellitus in HCC, we systematically reviewed published studies and carried out a meta-analysis. Eligible articles were identified in electronic databases from their inception through September 16, 2013. To evaluate the correlation between diabetes mellitus and prognosis in HCC, the pooled hazard ratios (HR) and their 95% confidence intervals (95% CI) for poorer overall and disease-free survivals were calculated by standard meta-analysis techniques with fixed-effects or random-effects models. 21 studies with a total of 9,767 HCC patients stratifying overall survival and/or disease-free survival in HCC patients by diabetes mellitus status were eligible for meta-analysis. 20 studies with a total of 9,727 HCC cases investigated the overall survival, and 10 studies with a total of 2,412 HCC patients investigated the disease-free survival. The pooled HRs for overall survival and disease-free survival were 1.46 (95% CI, 1.29 to 1.66; P<0.001) and 1.57 (95% CI, 1.21 to 2.05; P = 0.001), respectively. The adjusted HRs for overall survival and disease-free survival were 1.55 (95% CI, 1.27 to 1.91; P<0.001) and 2.15 (95% CI, 1.75 to 2.63; P<0.001), respectively. In addition, for patients receiving hepatic resection, diabetes mellitus was associated with both poorer overall survival and poorer disease-free survival, and for patients receiving non-surgical treatment or patients receiving radiofrequency ablation, diabetes mellitus was associated with poorer overall survival. There was no evidence for publication bias. Diabetes mellitus is independently associated with both poorer overall survival and poorer disease-free survival in HCC patients.

The Prevalence of Oropharyngeal Dysphagia in Adults Presenting with Temporomandibular Disorders Associated with Rheumatoid Arthritis: A Systematic Review and Meta-analysis.

PubMed

Gilheaney, Órla; Zgaga, Lina; Harpur, Isolde; Sheaf, Greg; Kiefer, Liss; Béchet, Sibylle; Walshe, Margaret

2017-10-01

Temporomandibular disorders (TMDs) are the most frequent non-dental orofacial pain disorders and may be associated with rheumatoid arthritis (RA), resulting in oropharyngeal dysphagia (OD). However, clinicians' understanding of involvement with OD caused by RA-related TMDs is limited and the methodological quality of research in this field has been criticised. Therefore, the aim of this study was to systematically review the prevalence of oral preparatory and oral stage signs and symptoms of OD in adults presenting with TMDs associated with RA. A systematic review of the literature was completed. The following electronic databases were searched from inception to February 2016, with no date/language restriction: EMBASE, PubMed, CINAHL, Web of Science, Elsevier Scopus, Science Direct, AMED, The Cochrane Database of Systematic Reviews, and ProQuest Dissertations and Theses A & I. Grey literature and reference lists of the included studies were also searched. Studies reporting the frequency of OD in adults presenting with TMD and RA were included. Study eligibility and quality were assessed by three independent reviewers. Methodological quality was assessed using the Down's and Black tool. The search yielded 19 eligible studies. Typical difficulties experienced by RA patients included impaired swallowing (24.63%), impaired masticatory ability (30.69%), masticatory pain (35.58%), and masticatory fatigue (21.26%). No eligible studies reported figures relating to the prevalence of weight loss. Eligible studies were deemed on average to be of moderate quality. Study limitations included the small number of studies which met the inclusion criteria and the limited amount of studies utilising objective assessments. Valid and reliable prospective research is urgently required to address the assessment and treatment of swallowing difficulties in RA as TMJ involvement may produce signs and symptoms of OD.

Association Between Number of Preventive Care Guidelines and Preventive Care Utilization by Patients.

PubMed

Taksler, Glen B; Pfoh, Elizabeth R; Stange, Kurt C; Rothberg, Michael B

2018-05-08

The number of preventive care guidelines is rapidly increasing. It is unknown whether the number of guideline-recommended preventive services is associated with utilization. The authors used Poisson regression of 390,778 person-years of electronic medical records data from 2008 to 2015, in 80,773 individuals aged 50-75 years. Analyses considered eligibility for 11 preventive services most closely associated with guidelines: tobacco cessation; control of obesity, hypertension, lipids, or blood glucose; influenza vaccination; and screening for breast, cervical, or colorectal cancers, abdominal aortic aneurysm, or osteoporosis. The outcome was the rate of preventive care utilization over the following year. Results were adjusted for demographics and stratified by the number of disease risk factors (smoking, obesity, hypertension, hyperlipidemia, diabetes). Data were collected in 2016 and analyzed in 2017. Preventive care utilization was lower when the number of guideline-recommended preventive services was higher. The adjusted rate of preventive care utilization decreased from 38.67 per 100 (95% CI=38.16, 39.18) in patients eligible for one guideline-recommended service to 31.59 per 100 (95% CI=31.29, 31.89) in patients eligible for two services and 25.43 per 100 (95% CI=24.68, 26.18) in patients eligible for six or more services (p-trend<0.001). Results were robust to disease risk factors and observed for all but two services (tobacco cessation, obesity reduction). However, for any given number of guideline-recommended services, patients with more disease risk factors had higher utilization rates. The rate of preventive care utilization was lower when the number of guideline-recommended services was higher. Prioritizing recommendations might improve utilization of high-value services. Copyright © 2018 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

LDH is an adverse prognostic factor independent of ISS in transplant-eligible myeloma patients receiving bortezomib-based induction regimens.

PubMed

Chim, Chor Sang; Sim, Joycelyn; Tam, Sidney; Tse, Eric; Lie, Albert Kwok Wai; Kwong, Yok Lam

2015-04-01

Serum lactate dehydrogenase (LDH) has been an adverse prognostic factor for myeloma but does not feature in the International Staging System (ISS). We examined whether elevated serum LDH at diagnosis remains an adverse risk factor independent of ISS for survivals transplant-eligible myeloma patients receiving early/frontline bortezomib-based induction, followed by autologous stem cell transplantation (ASCT). Seventy-seven transplant-eligible Chinese patients received three induction regimens [staged approach (N = 25), PAD (N = 19), VTD (N = 33)], followed by ASCT and thalidomide maintenance. Five-year overall (OS) and event-free (EFS) survivals were 66.4% and 36.2%. There was no difference in demographics, complete remission/near complete remission (CR/nCR rates postinduction or ASCT, and survivals among patients induced by the three induction regimens. Elevated LDH was associated with male gender (P = 0.006), ISS III (P = 0.042) and serum β2-microglobulin (P = 0.040). Univariate analysis showed that elevated LDH, ISS III, high β2-microglobulin, and failure to attain CR/nCR post-ACST were risk factors adversely impacting both OS and EFS. Multivariate analysis showed that elevated LDH was the only factor impacting both OS (P = 0.007) and EFS (P = 0.008). In this uniformly treated cohort of transplant-eligible myeloma patients, elevated serum LDH is an adverse risk factor independent of ISS for both OS and EFS. Bortezomib-based induction/ASCT regimen had not abolished the adverse impact of elevated LDH. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Combining motivational and volitional strategies to promote unsupervised walking in patients with fibromyalgia: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Fibromyalgia patients are often advised to engage in regular low- to moderate-intensity physical exercise. The need of fibromyalgia patients to walk has been stressed in previous research. Behavioral self-regulation theories suggest that a combination of motivational aspects (to develop or strengthen a behavioral intention: Theory of Planned Behavior) and volitional aspects (engagement of intention in behavior: implementation intentions) is more effective than a single intervention. In this paper, we describe a protocol for identifying the motivational processes (using the Theory of Planned Behavior) involved in the practice of walking (phase I) and for studying the efficacy of an intervention that combines motivational and volitional contents to enhance the acquisition and continuation of this exercise behavior (phase II). The paper also shows the characteristics of eligible individuals (women who do not walk) and ineligible populations (women who walk or do not walk because of comorbidity without medical recommendation to walk). Both groups consist of members of any of four patients’ associations in Spain who are between 18 and 70 years of age and meet the London Fibromyalgia Epidemiology Study Screening Questionnaire criteria for fibromyalgia. Furthermore, using this study protocol, we will explore the characteristics of participants (eligible women who agreed to participate in the study) and nonparticipants (eligible women who refused to participate). Methods/design Two studies will be conducted: Phase I will be a cross-sectional study, and phase II will be a triple-blind, randomized longitudinal study with two treatment groups and one active control group. The questionnaires were sent to a total of 2,227 members of four patients’ associations in Spain. A total of 920 participants with fibromyalgia returned the questionnaires, and 582 were ultimately selected to participate. Discussion The first data gathered have allowed us to identify the characteristics of the study population and they support the appropriateness of the inclusion criteria.. When the study is complete, the results will enable us to establish whether this kind of intervention can be used as a self-regulation tool for increasing and maintaining walking as unsupervised physical exercise of low to moderate intensity in fibromyalgia patients. Trial registration Trial registration number: ISRCTN68584893 PMID:24721143

Impact of relative contraindications to home management in emergency department patients with low-risk pulmonary embolism.

PubMed

Vinson, David R; Drenten, Carrieann E; Huang, Jie; Morley, J Eileen; Anderson, Megan L; Reed, Mary E; Nishijima, Daniel K; Liu, Vincent

2015-05-01

Studies of adults presenting to the emergency department (ED) with acute pulmonary embolism (PE) suggest that those who are low risk on the PE Severity Index (classes I and II) can be managed safely without hospitalization. However, the impact of relative contraindications to home management on outcomes has not been described. To compare 5-day and 30-day adverse event rates among low-risk ED patients with acute PE without and with outpatient ineligibility criteria. We conducted a retrospective multicenter cohort study of adults presenting to the ED with acute low-risk PE between 2010 and 2012. We evaluated the association between outpatient treatment eligibility criteria based on a comprehensive list of relative contraindications and 5-day adverse events and 30-day outcomes, including major hemorrhage, recurrent venous thromboembolism, and all-cause mortality. Of 423 adults with acute low-risk PE, 271 (64.1%) had no relative contraindications to outpatient treatment (outpatient eligible), whereas 152 (35.9%) had at least one contraindication (outpatient ineligible). Relative contraindications were categorized as PE-related factors (n = 112; 26.5%), comorbid illness (n = 42; 9.9%), and psychosocial barriers (n = 19; 4.5%). There were no 5-day events in the outpatient-eligible group (95% upper confidence limit, 1.7%) and two events (1.3%; 95% confidence interval [CI], 0.1-5.0%) in the outpatient-ineligible group (P = 0.13). At 30 days, there were five events (two recurrent venous thromboemboli and three major bleeding events) in the outpatient-eligible group (1.8%; 95% CI, 0.7-4.4%) compared with nine in the ineligible group (5.9%; 95% CI, 2.7-10.9%; P < 0.05). This difference remained significant when controlling for PE severity class. Nearly two-thirds of adults presenting to the ED with low-risk PE were potentially eligible for outpatient therapy. Relative contraindications to outpatient management were associated with an increased frequency of adverse events at 30 days among adults with low-risk PE.

Observational study shows that it is feasible to provide neuroprotective treatment for neonatal encephalopathy in low-income countries.

PubMed

Biselele, T; Bambi, J; Naulaers, G; Tabu, G; Kapinga, J; Bola, V; Makaya, P; Tjabbes, H; Tady, B; Peeters-Scholte, C

2018-02-09

Perinatal asphyxia is one of the most frequent causes of neonatal morbidity and mortality worldwide, and 96% of the burden of neonatal encephalopathy occurs in low-income countries. This study investigated the feasibility of providing neuroprotective treatment for neonatal encephalopathy in low-income countries. Neonates with a gestational age of at least 36 weeks, with signs of perinatal asphyxia, were included in this 2015 observational study in three hospitals in Kinshasa, capital of the Democratic Republic of Congo. Their characteristics were described, including the time to admission and Thompson score on admission. We found that 42 of 134 patients (31.3%) reached the hospital within six hours of birth with a Thompson score of at least seven on admission. Another 15 patients (11.2%) had a five-minute Apgar score of up to five, without a Thompson score, and were eligible for treatment. Of the 57 (42.5%) eligible patients, 31 were discharged (54.4%), 25 died (43.9%) and one (1.8%) remained in hospital at the end of the study. Interventional studies are feasible and necessary, especially in countries where the burden of neonatal encephalopathy is largest. A Thompson score of 7-15 might be a useful entry criterion for neuroprotective treatment in low-income countries. ©2018 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

Impact of reduction in working hours for doctors in training on postgraduate medical education and patients' outcomes: systematic review.

PubMed

Moonesinghe, S R; Lowery, J; Shahi, N; Millen, A; Beard, J D

2011-03-22

To determine whether a reduction in working hours of doctors in postgraduate medical training has had an effect on objective measures of medical education and clinical outcome. Systematic review. Medline, Embase, ISI Web of Science, Google Scholar, ERIC, and SIGLE were searched without language restriction for articles published between 1990 and December 2010. Reference lists and citations of selected articles. Studies that assessed the impact of a change in duty hours using any objective measure of outcome related to postgraduate medical training, patient safety, or clinical outcome. Any study design was eligible for inclusion. 72 studies were eligible for inclusion: 38 reporting training outcomes, 31 reporting outcomes in patients, and three reporting both. A reduction in working hours from greater than 80 hours a week (in accordance with US recommendations) does not seem to have adversely affected patient safety and has had limited effect on postgraduate training. Reports on the impact of European legislation limiting working hours to less than 56 or 48 a week are of poor quality and have conflicting results, meaning that firm conclusions cannot be made. Reducing working hours to less than 80 a week has not adversely affected outcomes in patient or postgraduate training in the US. The impact of reducing hours to less than 56 or 48 a week in the UK has not yet been sufficiently evaluated in high quality studies. Further work is required, particularly in the European Union, using large multicentre evaluations of the impact of duty hours' legislation on objective educational and clinical outcomes.

Recruitment Into a Pediatric Continuous Glucose Monitoring RCT.

PubMed

Volkening, Lisa K; Gaffney, Kaitlin C; Katz, Michelle L; Laffel, Lori M

2017-01-01

The purpose was to identify patient/family characteristics and recruitment process characteristics associated with the decision to participate in a 2-year continuous glucose monitoring (CGM) RCT for youth with type 1 diabetes and their families. Study staff approached patients who were conditionally eligible according to medical record review or referred by a provider. We categorized families according to participation decision (agree vs decline) and timing of decision (day of approach vs later ["thinkers"]). Over 18 months, we approached 456 eligible patients; 19% agreed on the day of approach, 10% agreed later, 42% declined on the day of approach, and 30% declined later. Agreers were younger ( P = .002), had shorter diabetes duration ( P = .0003), had a lower insulin dose ( P = .02), checked blood glucose levels more often ( P = .002), and were more likely to use pump therapy ( P = .009) than decliners. Patients/families were more likely to agree in fall/winter (41%) than spring/summer (19%, P < .0001). Of decliners, 50% cited no interest in CGM as the reason for nonparticipation. Among thinkers, 49% of patients who made a decision within 2 weeks of being approached agreed; only 15% of thinkers who made a decision >2 weeks after being approached agreed to participate ( P < .0001). Recruitment is a critical and often challenging phase of clinical trials. Recruitment to pediatric CGM studies may be especially challenging due to youths' reluctance to use CGM. These data provide an opportunity to better understand and possibly optimize recruitment into future pediatric CGM studies and other studies of advanced diabetes technologies.

Opioid use following the introduction of an extended-release oxycodone formulation with tamper-resistant properties: Prospective historical chart review in methadone-maintained patients.

PubMed

Sankey, Christopher; Setnik, Beatrice; Harsanyi, Zoltan; Michalko, Ken; Yang, Zejiang; Geoffroy, Pierre

2016-01-01

Emerging data are demonstrating that tamper-resistant opioids may play an important role in changing prescription opioid abuse behaviors. This study was a chart review to examine if the reformulation of OxyContin® into a version with tamper-resistant properties (OxyNEO®) had an impact on oxycodone-positive urine drug screens (UDSs) in opioid-dependent patients receiving methadone maintenance therapy (MMT). The historical element of this study examined 250 eligible charts from patients on MMT who had data during the time periods when only OxyContin was available (baseline period), during the transition to OxyNEO, and when only OxyNEO was available. The prospective element included an exploratory questionnaire regarding retrospective opioid use. The study was conducted at three methadone clinics, in Oshawa, Peterborough, and Scarborough in Ontario, Canada. Male and female patients were eligible if they had a diagnosis of opioid dependency, received MMT, and had at least one oxycodone-positive UDS during the baseline period. This was a noninterventional study. The main outcome was the number of oxycodonepositive UDSs. The results demonstrated a marked reduction in oxycodone-positive UDSs that showed stepwise, statistically significant decreases during the transition and post-OxyContin periods relative to baseline. While the oxycodone-positive UDS results were decreasing, morphine-related-positive UDSs remained relatively stable during the same periods. There were no significant gender differences noted. The introduction of OxyNEO was associated with a statistically significant reduction in oxycodone exposure in a population of methadone-maintained patients.

Increased Patient Enrollment to a Randomized Surgical Trial Through Equipoise Polling of an Expert Surgeon Panel.

PubMed

Ghogawala, Zoher; Schwartz, J Sanford; Benzel, Edward C; Magge, Subu N; Coumans, Jean Valery; Harrington, J Fred; Gelbs, Jared C; Whitmore, Robert G; Butler, William E; Barker, Fred G

2016-07-01

To determine whether patients who learned the views of an expert surgeons' panel's assessment of equipoise between 2 alternative operative treatments had increased likelihood of consenting to randomization. Difficulty obtaining patient consent to randomization is an important barrier to conducting surgical randomized clinical trials, the gold standard for generating clinical evidence. Observational study of the rate of patient acceptance of randomization within a 5-center randomized clinical trial comparing lumbar spinal decompression versus lumbar spinal decompression plus instrumented fusion for patients with symptomatic grade I degenerative lumbar spondylolisthesis with spinal stenosis. Eligible patients were enrolled in the trial and then asked to accept randomization. A panel of 10 expert spine surgeons was formed to review clinical information and images for individual patients to provide an assessment of suitability for randomization. The expert panel vote was disclosed to the patient by the patient's surgeon before the patient decided whether to accept randomization or not. Randomization acceptance among eligible patients without expert panel review was 40% (19/48) compared with 81% (47/58) among patients undergoing expert panel review (P < 0.001). Among expert-reviewed patients, randomization acceptance was 95% when all experts or all except 1 voted for randomization, 75% when 2 experts voted against randomization, and 20% with 3 or 4 votes against (P < 0.001 for trend). Patients provided with an expert panel's assessment of their own suitability for randomization were twice as likely to agree to randomization compared with patients receiving only their own surgeon's recommendation.

Effectiveness of interspinous implant surgery in patients with intermittent neurogenic claudication: a systematic review and meta-analysis.

PubMed

Moojen, Wouter A; Arts, Mark P; Bartels, Ronald H M A; Jacobs, Wilco C H; Peul, Wilco C

2011-10-01

Despite an increasing implantation rate of interspinous process distraction (IPD) devices in the treatment of intermittent neurogenic claudication (INC), definitive evidence on the clinical effectiveness of implants is lacking. The main objective of this review was to perform a meta-analysis of all systematic reviews, randomized clinical trials and prospective cohort series to quantify the effectiveness of IPDs and to evaluate the potential side-effects. Data from all studies prospectively describing clinical results based on validated outcome scales and reporting complications of treatment of patients with INC with IPD placement. We searched MEDLINE, EMBASE, Web of Science, Cochrane (CENTRAL), CINAHL, Academic Search Premier, Science Direct up to July 2010. Studies describing patients with INC caused by lumbar stenosis, reporting complication rate and reporting based on validated outcome scores, were eligible. Studies with only instrumented IPD results were excluded. Eleven studies eligible studies were identified. Two independently RCTs and eight prospective cohorts were available. In total 563 patients were treated with IPDs. All studies showed improvement in validated outcome scores after 6 weeks and 1 year. Pooled data based on the Zurich Claudication Questionnaire of the RCTs were more in favor of IPD treatment compared with conservative treatment (pooled estimate 23.2, SD 18.5-27.8). Statistical heterogeneity after pooled data was low (I-squared 0.0, p = 0.930). Overall complication rate was 7%. As the evidence is relatively low and the costs are high, more thorough (cost-) effectiveness studies should be performed before worldwide implementation is introduced.

Patient Satisfaction With Pharmacist-Led Chronic Disease State Management Programs.

PubMed

Schuessler, Tyler J; Ruisinger, Janelle F; Hare, Sarah E; Prohaska, Emily S; Melton, Brittany L

2016-10-01

To assess patient satisfaction, perception of self-management, and perception of disease state knowledge with pharmacist-led diabetes and cardiovascular disease state management (DSM) programs. A self-insured chain of grocery store pharmacies in the Kansas City metropolitan area administers pharmacist-led diabetes and cardiovascular DSM programs for eligible employees and dependents. A modified version of the Diabetes Disease State Management Questionnaire was used to assess patient satisfaction with the DSM programs. Demographic information was also collected. Survey items were based on a 5-point Likert scale (1 = strongly disagree and 5 = strongly agree). Patients were eligible to complete the survey if he or she had been in at least 1 DSM program for 6 months. Data were assessed using descriptive statistics and analysis of variance. Across 20 pharmacies, 281 eligible participants were identified, and 46% (n = 128) completed a survey. Means for summed items relating to overall satisfaction (8 items), self-management (5 items), and knowledge (4 items) were 36.6/40 (standard deviation [SD] = 3.9), 20.9/25 (SD = 3.4), and 17.6/20 (SD = 2.1), respectively. Participant comments further indicated that the program and pharmacists are helpful and increase motivation and accountability. Positive patient responses to the program support use of pharmacist-led DSM programs. © The Author(s) 2015.

Facilitation of blood donation amongst haemochromatosis patients.

PubMed

Marrow, B; Clarkson, J; Chapman, C E; Masson, S

2015-08-01

The standard medical therapy for haemochromatosis is iron removal by regular phlebotomy. Current guidelines suggest that this blood should be made available through national blood services. Here, we describe a pilot facilitating the process of blood donation amongst uncomplicated haemochromatosis patients. At a dedicated clinic, patients with uncomplicated haemochromatosis interested in becoming blood donors were offered an information leaflet and self-referral application. Upon receipt, members of the local Blood Service contacted them to confirm eligibility to donate. Data on demographics and clinical characteristics, including HFE (high Fe) genotype, co-morbidities, alcohol consumption and body mass index, were collected. Since establishing the clinic, 140 patients have attended (93 male) with median age 57. Most (n = 125; 89%) had uncomplicated haemochromatosis. Of these, 55 were potentially eligible blood donors. Amongst those eligible, there are now 29 regular blood donors, including 23 new. There is an interest and willingness to donate blood through the Blood Service amongst uncomplicated haemochromatosis patients undergoing therapeutic phlebotomy. Since the introduction of this facilitation process, we have significantly increased the number of regular donors amongst this cohort. If this process was to be replicated more widely across the UK, this could have a significant impact on the blood donor pool. © 2015 British Blood Transfusion Society.

Impact of acute bleeding on daily activities of patients with congenital hemophilia with inhibitors and their caregivers and families: observations from the Dosing Observational Study in Hemophilia (DOSE).

PubMed

Recht, Michael; Neufeld, Ellis J; Sharma, Vivek R; Solem, Caitlyn T; Pickard, A Simon; Gut, Robert Z; Cooper, David L

2014-09-01

There is limited understanding of the effects of bleeding episodes on the daily lives of patients with congenital hemophilia with inhibitors and their caregivers. This analysis of the Dosing Observational Study in Hemophilia examined the impact of acute bleeding episodes on work, school, and family activities. Patients and caregivers participated in a diary study for 90 or more days or until patients experienced four bleeding episodes. All bleed treatments, interference with daily activities, and quality-of-life assessments were captured in daily records. Patients and caregivers reported planned workdays or school days eligible to be "lost" so as to differentiate from days lost because of disability or nonworking status, weekends, and vacations. Diaries were completed for 39 patients (18 adults and 21 children). Bleeding episodes that continued for 3 or more days (16.4%) accounted for most of the major changes to family plans. For the 38 patients with bleeding episodes, 47% of 491 bleed days fell on planned workdays or school days; the remainder fell on weekends, holidays, or nonworkdays or non-school days and therefore did not count as "lost days." Patients reported a loss of productivity on a greater percentage of eligible bleed days than did caregivers (3.9% vs. 0.8%, respectively). Patients and caregivers reported 13.5%/9.3% fully missed and 3.5%/7.6% partially missed days. This study demonstrated that in hemophilia with inhibitors, bleeding episodes interfere with the daily activities of patients and their caregivers. Furthermore, documenting only lost days underestimated the impact of bleeding episodes because of the high percentage of days without planned work or school. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Risk factors for hospitalisation and associated costs among patients with hepatitis A associated with imported pomegranate arils, United States, 2013.

PubMed

Epson, E E; Cronquist, A; Lamba, K; Kimura, A C; Hassan, R; Selvage, D; McNeil, C S; Varan, A K; Silvaggio, J L; Fan, L; Tong, X; Spradling, P R

2016-07-01

To assess hospitalisation risk factors and economic effects associated with a multistate hepatitis A outbreak in 2013. Retrospective case series. Eligible outbreak-related cases confirmed by September 1, 2013, were defined as acute hepatitis symptoms and positive IgM anti-hepatitis A during March 15-August 12 among patients who consumed the food vehicle or had the outbreak genotype. We reviewed medical records, comparing demographic and clinical characteristics among hospitalized and non-hospitalized patients; we used logistic regression analysis to identify factors associated with hospitalization. We interviewed patients regarding symptom duration and healthcare usage and estimated per-patient and total costs. Health departments reported outbreak-related personnel hours. Medical records were reviewed for 147/159 (92%) eligible patients; median age was 48 (range: 1-84) years, and 64 (44%) patients were hospitalized. Having any chronic medical condition was independently associated with hospitalisation (odds ratio, 3.80; 95% confidence interval, 1.68-8.62). Interviews were completed for 114 (72%) eligible patients; estimated per-patient cost of healthcare and productivity loss was $13,467 for hospitalized and $2138 for non-hospitalized patients and $1,304,648 for all 165 outbreak-related cases. State and local public health personnel expenditures included 82 h and $3221/outbreak-related case. Hospitalisations in this outbreak were associated with chronic medical conditions and resulted in substantial healthcare usage and lost productivity. These data can be used to inform future evaluation of expansion of hepatitis A vaccination recommendations to include adults with chronic medical conditions. Published by Elsevier Ltd.

Predictors of Payer Mix and Financial Performance Among Safety Net Hospitals Prior to the Affordable Care Act.

PubMed

Sommers, Benjamin D; Stone, Juliana; Kane, Nancy

2016-01-01

The objective of this study was to use audited hospital financial statements to identify predictors of payer mix and financial performance in safety net hospitals prior to the Affordable Care Act. We analyzed the 2010 financial statements of 98 large, urban safety net hospital systems in 34 states, supplemented with data on population demographics, hospital features, and state policies. We used multivariate regression to identify independent predictors of three outcomes: 1) Medicaid-reliant payer mix (hospitals for which at least 25% of hospital days are paid for by Medicaid); 2) safety net revenue-to-cost ratio (Medicaid and Medicare Disproportionate Share Hospital payments and local government transfers, divided by charity care costs and Medicaid payment shortfall); and 3) operating margin. Medicaid-reliant payer mix was positively associated with more inclusive state Medicaid eligibility criteria and more minority patients. More inclusive Medicaid eligibility and higher Medicaid reimbursement rates positively predicted safety net revenue-to-cost ratio. University governance was the strongest positive predictor of operating margin. Safety net hospital financial performance varied considerably. Academic hospitals had higher operating margins, while more generous Medicaid eligibility and reimbursement policies improved hospitals' ability to recoup costs. Institutional and state policies may outweigh patient demographics in the financial health of safety net hospitals. © The Author(s) 2015.

Translation of alcohol screening and brief intervention guidelines to pediatric trauma centers.

PubMed

Mello, Michael J; Bromberg, Julie; Baird, Janette; Nirenberg, Ted; Chun, Thomas; Lee, Christina; Linakis, James G

2013-10-01

As part of the American College of Surgeons verification to be a Level 1 trauma center, centers are required to have the capacity to identify trauma patients with risky alcohol use and provide an intervention. Despite supporting scientific evidence and national policy statements encouraging alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT), barriers still exist, which prevent the integration of SBIRT into clinical care. Study objectives of this multisite translational research study were to identify best practices for integrating SBIRT services into routine care for pediatric trauma patients, to measure changes in practice with adoption and implementation of a SBIRT policy, and to define barriers and opportunities for adoption and implementation of SBIRT services at pediatric trauma centers. This translational research study was conducted at seven US pediatric trauma centers during a 3-year period. Changes in SBIRT practice were measured through self-report and medical record review at three different study phases, namely, adoption, implementation, and maintenance phases. According to medical record review, at baseline, 11% of eligible patients were screened and received a brief intervention (if necessary) across all sites. After completion of the SBIRT technical assistance activities, all seven participating trauma centers had effectively developed, adopted, and implemented SBIRT policies for injured adolescent inpatients. Furthermore, across all sites, 73% of eligible patients received SBIRT services after both the implementation and maintenance phases. Opportunities and barriers for successful integration were identified. This model may serve as method for translating SBIRT services into practice within pediatric trauma centers.

Cardiovascular Risk and Statin Eligibility of Young Adults After an MI: Partners YOUNG-MI Registry.

PubMed

Singh, Avinainder; Collins, Bradley L; Gupta, Ankur; Fatima, Amber; Qamar, Arman; Biery, David; Baez, Julio; Cawley, Mary; Klein, Josh; Hainer, Jon; Plutzky, Jorge; Cannon, Christopher P; Nasir, Khurram; Di Carli, Marcelo F; Bhatt, Deepak L; Blankstein, Ron

2018-01-23

Despite significant progress in primary prevention, the rate of MI has not declined in young adults. The purpose of this study was to evaluate statin eligibility based on the 2013 American College of Cardiology/American Heart Association guidelines for treatment of blood cholesterol and 2016 U.S. Preventive Services Task Force recommendations for statin use in primary prevention in a cohort of adults who experienced a first-time myocardial infarction (MI) at a young age. The YOUNG-MI registry is a retrospective cohort from 2 large academic centers, which includes patients who experienced an MI at age ≤50 years. Diagnosis of type 1 MI was adjudicated by study physicians. Pooled cohort risk equations were used to estimate atherosclerotic cardiovascular disease risk score based on data available prior to MI or at the time of presentation. Of 1,685 patients meeting inclusion criteria, 210 (12.5%) were on statin therapy prior to MI and were excluded. Among the remaining 1,475 individuals, the median age was 45 years, there were 294 (20%) women, and 846 (57%) had ST-segment elevation MI. At least 1 cardiovascular risk factor was present in 1,225 (83%) patients. The median 10-year atherosclerotic cardiovascular disease risk score of the cohort was 4.8% (interquartile range: 2.8% to 8.0%). Only 724 (49%) and 430 (29%) would have met criteria for statin eligibility per the 2013 American College of Cardiology/American Heart Association guidelines and 2016 U.S. Preventive Services Task Force recommendations, respectively. This finding was even more pronounced in women, in whom 184 (63%) were not eligible for statins by either guideline, compared with 549 (46%) men (p < 0.001). The vast majority of adults who present with an MI at a young age would not have met current guideline-based treatment thresholds for statin therapy prior to their MI. These findings highlight the need for better risk assessment tools among young adults. Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Prospective Trial of Stereotactic Body Radiation Therapy for Both Operable and Inoperable T1N0M0 Non-Small Cell Lung Cancer: Japan Clinical Oncology Group Study JCOG0403

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nagata, Yasushi, E-mail: nagat@hiroshima-u.ac.jp; Hiraoka, Masahiro; Shibata, Taro

2015-12-01

Purpose: To evaluate, in Japan Clinical Oncology Group study 0403, the safety and efficacy of stereotactic body radiation therapy (SBRT) in patients with T1N0M0 non-small cell lung cancer (NSCLC). Methods and Materials: Eligibility criteria included histologically or cytologically proven NSCLC, clinical T1N0M0. Prescribed dose was 48 Gy at the isocenter in 4 fractions. The primary endpoint was the percent (%) 3-year overall survival. The threshold % 3-year survival to be rejected was set at 35% for inoperable patients, whereas the expected % 3-year survival was 80% for operable patients. Results: Between July 2004 and November 2008, 169 patients from 15 institutionsmore » were registered. One hundred inoperable and 64 operable patients (total 164) were eligible. Patients' characteristics were 122 male, 47 female; median age 78 years (range, 50-91 years); adenocarcinomas, 90; squamous cell carcinomas, 61; others, 18. Of the 100 inoperable patients, the % 3-year OS was 59.9% (95% confidence interval 49.6%-68.8%). Grade 3 and 4 toxicities were observed in 10 and 2 patients, respectively. No grade 5 toxicity was observed. Of the 64 operable patients, the % 3-year OS was 76.5% (95% confidence interval 64.0%-85.1%). Grade 3 toxicities were observed in 5 patients. No grade 4 and 5 toxicities were observed. Conclusions: Stereotactic body radiation therapy for stage I NSCLC is effective, with low incidences of severe toxicity. This treatment can be considered a standard treatment for inoperable stage I NSCLC. This treatment is promising as an alternative to surgery for operable stage I NSCLC.« less

A phase II trial of 17-allylamino-17-demethoxygeldanamycin in patients with hormone-refractory metastatic prostate cancer.

PubMed

Heath, Elisabeth I; Hillman, David W; Vaishampayan, Ulka; Sheng, Shijie; Sarkar, Fazlul; Harper, Felicity; Gaskins, Melvin; Pitot, Henry C; Tan, Winston; Ivy, S Percy; Pili, Roberto; Carducci, Michael A; Erlichman, Charles; Liu, Glenn

2008-12-01

17-Allylamino-17-demethoxygeldanamycin (17-AAG) is a benzoquinone ansamycin antibiotic with antiproliferative activity in several mouse xenograft models, including prostate cancer models. A two-stage phase II study was conducted to assess the activity and toxicity profile of 17-AAG administered to patients with metastatic, hormone-refractory prostate cancer. Patients with at least one prior systemic therapy and a rising prostate-specific antigen (PSA) were eligible. Patients received 17-AAG at a dose of 300 mg/m2 i.v. weekly for 3 of 4 weeks. The primary objective was to assess the PSA response. Secondary objectives were to determine overall survival, to assess toxicity, and to measure interleukin-6, interleukin-8, and maspin levels and quality of life. Fifteen eligible patients were enrolled. The median age was 68 years and the median PSA was 261 ng/mL. Patients received 17-AAG for a median number of two cycles. Severe adverse events included grade 3 fatigue (four patients), grade 3 lymphopenia (two patients), and grade 3 back pain (two patients). The median PSA progression-free survival was 1.8 months (95% confidence interval, 1.3-3.4 months). The 6-month overall survival was 71% (95% confidence interval, 52-100%). 17-AAG did not show any activity with regard to PSA response. Due to insufficient PSA response, enrollment was stopped at the end of first stage per study design. The most significant severe toxicity was grade 3 fatigue. Further evaluation of 17-AAG at a dose of 300 mg/m2 i.v. weekly as a single agent in patients with metastatic, hormone-refractory prostate cancer who received at least one prior systemic therapy is not warranted.

Prevalence of Substance Use Among Patients of Community Health Centers in East Los Angeles and Tijuana.

PubMed

Gelberg, Lillian; Natera Rey, Guillermina; Andersen, Ronald M; Arroyo, Miriam; Bojorquez-Chapela, Ietza; Rico, Melvin W; Vahidi, Mani; Yacenda-Murphy, Julia; Arangua, Lisa; Serota, Martin

2017-02-23

Given the increased use of psychoactive substances on the United States-Mexico border, a binational study (Tijuana, Mexico-Los Angeles, USA) was conducted to identify the prevalence of substance use in primary care settings. To compare the prevalence and characteristics of patients at risk for substance use disorders in Tijuana and East Los Angeles (LA) community clinics with special attention paid to drug use. This was an observational, cross-sectional, analytical study, comparing substance use screening results from patients in Tijuana and LA. The settings were 2 community clinics in LA and 6 in Tijuana. Participants were 2,507 adult patients in LA and 2,890 in Tijuana eligible for WHO Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) screening during March-October 2013. Patients anonymously self-administered the WHO ASSIST on a tablet PC in the clinic waiting rooms. Of eligible patients, 96.4% completed the ASSIST in Tijuana and 88.7% in LA (mean 1.34 minutes and 4.20 minutes, respectively). The prevalence of patients with moderate-to-high substance use was higher in LA than Tijuana for each substance: drugs 19.4% vs. 5.7%, alcohol 15.2% vs. 6.5%, tobacco 20.4% vs. 16.2%. LA patients born in Mexico had 2x the odds and LA patients born in the United States had 6x the odds of being a moderate-to-high drug user compared to Tijuana patients born in Mexico. Moderate-to-high drug use is higher in LA than in Tijuana but rates are sufficiently high in both to suggest that screening for drug use (along with alcohol and tobacco use) should be integrated into routine primary care of community clinics in both cities.

Blood donor selection in European Union directives: room for improvement

PubMed Central

de Kort, Wim; Mayr, Wolfgang; Jungbauer, Christof; Vuk, Tomislav; Kullaste, Riin; Seifried, Erhard; Grazzini, Giuliano; de Wit, Jeroen; Folléa, Gilles

2016-01-01

Background Transfusion-transmissible infections have made both blood bankers and health authorities overly cautious. The general public expects and hence reinforces this policy. To obtain a high level of blood product safety, blood and plasma donors have to meet increasingly stringent eligibility criteria; however, it is not known whether this policy translates into improved outcomes for patients. There is a risk that the management of donors does not match the ambition of greater safety for patients. European directives related to the collection process and donor selection will probably be reconsidered in the next few years. Material and methods The development of European directives on donor selection and their basis in the literature were reviewed with an emphasis on the background and considerations for eligibility criteria to be included in the directives. Results The precautionary principle appears to be the predominant reason behind the set of eligibility criteria. However, the formal eligibility criteria, put into force in 2004, do not balance with the developments of the past decade in laboratory tests and measures that have substantially reduced actual infection risks. In no cases were the effects of eligibility criteria on the donor pool and donor well-being quantified. Regional differences in the epidemiology of transfusion-transmissible infections were not taken into consideration either. Discussion First, the Authors promote the collection of epidemiological data on the incidence and prevalence of conditions in the general population and in blood and plasma donors which could pose a risk for transfused patients, in order to use these data as a basis for decision-making in donor-selection policies. Second, the Authors suggest including allowance for differential deferral criteria throughout Europe, based on factual risk levels. There should be an accepted balance between donor and patient welfare, and also between risk to transfusion safety and risk of compromising the blood supply. PMID:26509824

A systematic review of discontinued trials suggested that most reasons for recruitment failure were preventable.

PubMed

Briel, Matthias; Olu, Kelechi Kalu; von Elm, Erik; Kasenda, Benjamin; Alturki, Reem; Agarwal, Arnav; Bhatnagar, Neera; Schandelmaier, Stefan

2016-12-01

To collect and classify reported reasons for recruitment failure in discontinued randomized controlled trials (RCTs) and to assess reporting quality. We systematically searched MEDLINE and EMBASE (2010-2014) and a previous cohort of RCTs for published RCTs reporting trial discontinuation due to poor recruitment. Teams of two investigators selected eligible RCTs working independently and extracted information using standardized forms. We used an iterative approach to classify reasons for poor recruitment. We included 172 RCTs discontinued due to poor recruitment (including 26 conference abstracts and 63 industry-funded RCTs). Of those, 131 (76%) reported one or more reasons for discontinuation due to poor recruitment. We identified 28 different reasons for recruitment failure; most frequently mentioned were overestimation of prevalence of eligible participants and prejudiced views of recruiters and participants on trial interventions. Few RCTs reported relevant details about the recruitment process such as how eligible participants were identified, the number of patients assessed for eligibility, and who actually recruited participants. Our classification could serve as a checklist to assist investigators in the planning of RCTs. Most reasons for recruitment failure seem preventable with a pilot study that applies the planned informed consent procedure. Copyright © 2016 Elsevier Inc. All rights reserved.

Blood Pressure and Cholesterol-lowering Efficacy of a Fixed-dose Combination With Irbesartan and Atorvastatin in Patients With Hypertension and Hypercholesterolemia: A Randomized, Double-blind, Factorial, Multicenter Phase III Study.

PubMed

Kim, Sang-Hyun; Jo, Sang-Ho; Lee, Sang-Cheol; Lee, Sung-Yoon; Yoon, Myung-Ho; Lee, Hyang-Lim; Lee, Nae-Hee; Ha, Jong-Won; Lee, Nam-Ho; Kim, Dong-Woon; Han, Gyu-Rok; Hyon, Min-Su; Cho, Deok-Gyu; Park, Chang-Gyu; Kim, Young-Dae; Ryu, Gyu-Hyung; Kim, Cheol-Ho; Kim, Kee-Sik; Chung, Myung-Ho; Chae, Sung-Chul; Seung, Ki-Bae; Oh, Byung-Hee

2016-10-01

A fixed-dose combination of a stain and an antihypertensive drug may be useful for the treatment of patients with hypertension and hyperlipidemia. It may also improve patient drug compliance to help control risk factors of cardiovascular disease. This study was designed to evaluate the blood pressure-lowering and cholesterol-lowering effect of a fixed-dose combination of irbesartan-atorvastatin compared with monotherapy by either agent over an 8-week treatment period. Patients with comorbid hypertension and hypercholesterolemia were screened for this randomized, double-blind, Phase III study. Eligible study patients were randomly assigned to test groups receiving a combination of irbesartan 300 mg and atorvastatin 40 mg or 80 mg (IRB300 + ATO40 and IRB300 + ATO80). Comparator groups comprised monotherapy groups with irbesartan 300 mg (IRB300) or atorvastatin 40 mg (ATO40) or atorvastatin 80 mg (ATO80), or placebo. Patients who were eligible at screening were subjected to a 4- to 6-week washout period before commencing 8 weeks of therapy per their assigned group. The primary efficacy end points were percent change in LDL-C and sitting diastolic blood pressure (DBP) levels from baseline to end of therapy. Tolerability profiles of combination therapy were compared with other groups. A total of 733 patients with comorbid hypertension and hypercholesterolemia were screened for this study; 230 eligible patients were randomized to treatment. The mean age of patients was 58.9 (8.5) years, and their mean body mass index was 25.8 (3.2) kg/m 2 . More than two thirds (70.9%) of the study patients were male. Mean LDL-C and sitting DBP levels at baseline were 149.54 (29.19) mg/dL and 92.32 (6.03) mm Hg, respectively. Percent reductions in LDL-C after 8 weeks were 46.74% (2.06%) in the IRB300 + ATO40 group and 48.98% (2.12%) in the IRB300 + ATO80 group; these values were 47.13% (3.21%) and 48.30% (2.98%) in the ATO40 and ATO80 comparator groups. Similarly, a reduction in sitting DBP after 8 weeks was -8.50 (1.06) mm Hg in the IRB300 + ATO40 group and 10.66 (1.08) mm Hg in the IRB300 + ATO80 group compared with 8.40 (1.65) mm Hg in the IRB300 group. The incidence rate for treatment-emergent adverse events was 22.27% and was similar between the monotherapy and combination groups. A once-daily combination product of irbesartan and atorvastatin provided an effective, safe, and more compliable treatment for patients with coexisting hypertension and hyperlipidemia. ClinicalTrials.gov identifier: NCT01442987. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Economic support to improve tuberculosis treatment outcomes in South Africa: a pragmatic cluster-randomized controlled trial.

PubMed

Lutge, Elizabeth; Lewin, Simon; Volmink, Jimmy; Friedman, Irwin; Lombard, Carl

2013-05-28

Poverty undermines adherence to tuberculosis treatment. Economic support may both encourage and enable patients to complete treatment. In South Africa, which carries a high burden of tuberculosis, such support may improve the currently poor outcomes of patients on tuberculosis treatment. The aim of this study was to test the feasibility and effectiveness of delivering economic support to patients with pulmonary tuberculosis in a high-burden province of South Africa. This was a pragmatic, unblinded, two-arm cluster-randomized controlled trial, where 20 public sector clinics acted as clusters. Patients with pulmonary tuberculosis in intervention clinics (n = 2,107) were offered a monthly voucher of ZAR120.00 (approximately US$15) until the completion of their treatment. Vouchers were redeemed at local shops for foodstuffs. Patients in control clinics (n = 1,984) received usual tuberculosis care. Intention to treat analysis showed a small but non-significant improvement in treatment success rates in intervention clinics (intervention 76.2%; control 70.7%; risk difference 5.6% (95% confidence interval: -1.2%, 12.3%), P = 0.107). Low fidelity to the intervention meant that 36.2% of eligible patients did not receive a voucher at all, 32.3% received a voucher for between one and three months and 31.5% received a voucher for four to eight months of treatment. There was a strong dose-response relationship between frequency of receipt of the voucher and treatment success (P <0.001). Our pragmatic trial has shown that, in the real world setting of public sector clinics in South Africa, economic support to patients with tuberculosis does not significantly improve outcomes on treatment. However, the low fidelity to the delivery of our voucher meant that a third of eligible patients did not receive it. Among patients in intervention clinics who received the voucher at least once, treatment success rates were significantly improved. Further operational research is needed to explore how best to ensure the consistent and appropriate delivery of such support to those eligible to receive it.

HIV in East London: ethnicity, gender and risk. Design and methods.

PubMed

Elford, Jonathan; Anderson, Jane; Bukutu, Cecilia; Ibrahim, Fowzia

2006-06-09

While men who have sex with men remain the group at greatest risk of acquiring HIV infection in the UK, the number of new diagnoses among heterosexuals has risen steadily over the last five years. In the UK, three-quarters of heterosexual men and women diagnosed with HIV in 2004 probably acquired their infection in Africa. This changing epidemiological pattern is particularly pronounced in East London because of its ethnically diverse population. The objective of the study was to examine the social, economic and behavioural characteristics of patients with HIV infection currently receiving treatment and care in hospitals in East London. The research focused on ethnicity, gender, sexuality, education, employment, housing, HIV treatment, stigma, discrimination, religion, migration and sexual risk behaviour. People diagnosed with HIV infection attending outpatient treatment clinics at St Bartholomew's, the Royal London, Whipp's Cross, Homerton, Newham and Barking hospitals (all in East London) over a 4-6 month period were invited to participate in the study in 2004-2005. Those who agreed to participate completed a confidential, self-administered pen-and-paper questionnaire. During the study period, 2680 patients with HIV attended the outpatient clinics in the six participating hospitals, of whom 2299 were eligible for the study and 1687 completed a questionnaire. The response rate was 73% of eligible patients and 63% of all patients attending the clinics during the survey period. A clinic-based study has allowed us to survey nearly 1700 patients with HIV from diverse backgrounds receiving treatment and care in East London. The data collected in this study will provide valuable information for the planning and delivery of appropriate clinical care, social support and health promotion for people living with HIV not only in East London but in other parts of the capital as well as elsewhere in the UK.

Population-based breast cancer screening in a primary care network

PubMed Central

Atlas, Steven J.; Ashburner, Jeffrey M.; Chang, Yuchiao; Lester, William T.; Barry, Michael J.; Grant, Richard W.

2013-01-01

Objective To assess up to 3-year follow-up of a health information technology system that facilitated population-based breast cancer screening. Study Design Cohort study with 2-year follow-up after completing a 1-year cluster randomized trial. Methods Women 42-69 years old receiving care within a 12-practice primary care network. The trial tested an integrated, non-visit-based population management informatics system that: 1) identified women overdue for mammograms, 2) connected them to primary care providers using a Web-based tool, 3) created automatically-generated outreach letters for patients specified by providers, 4) monitored for subsequent mammography scheduling and completion, and 5) provided practice delegates a list of women remaining unscreened for reminder phone calls. All practices also provided visit-based cancer screening reminders. Eligible women overdue for a mammogram during a one-year study period included those overdue at study start (prevalent cohort) or becoming overdue during follow-up (incident cohort). The main outcome measure was mammography completion rates over three years. Results Among 32,688 eligible women, 9,795 (30%) were overdue for screening including 4,487 in intervention and 5,308 in control practices. Intervention patients were somewhat younger, more likely to be non-Hispanic white, and have health insurance compared to control patients. Among patients in the prevalent cohort (n=6,697), adjusted completion rates were significantly higher among intervention compared to control patients after 3 years (51.7% vs. 45.8%, p=0.002). For patients in the incident cohort (n=3,098), adjusted completion rates after 2 years were 53.8% vs. 48.7%, p=0.052, respectively. Conclusions Population-based informatics systems can enable sustained increases in mammography screening rates beyond that seen with office-based visit reminders. PMID:23286611

Strengths, Limitations, and Geographical Discrepancies in the Eligibility Criteria for Sport Participation in Young Patients With Congenital Heart Disease.

PubMed

Cantinotti, Massimiliano; Giordano, Raffaele; Assanta, Nadia; Murzi, Bruno; Melo, Manuel; Franchi, Eliana; Crocetti, Maura; Iervasi, Giorgio; Kutty, Shelby

2017-07-21

Benefits of physical activity has been shown in children with congenital heart disease (CHD). In several forms of CHD, the risk of sudden death remains a major concern both for parents and clinicians, who in turn will have to consider the risk-benefit ratio of sport participation versus restriction. A literature search was performed within the National Library of Medicine using the keywords: Sport, CHD, and Eligibility. The search was further refined by adding the keywords: Children, Adult, and Criteria. Fifteen published studies evaluating sport eligibility criteria in CHD were included. Seven documents from various scientific societies have been published in the past decade but which of them should be adopted remains unclear. Our research highlighted accuracy and consistency of the latest documents; however, differences have emerged between the US and European recommendations. Eligibility criteria were consistent between countries for simple congenital heart defects, whereas there are discrepancies for borderline conditions including moderate valvular lesions and mild or moderate residual defects after CHD repair. Furthermore, some of the more severe defects were not evaluated. Multiple recommendations have been made for the same CHD, and cut-off values used to define disease severity have varied. Published eligibility criteria have mainly focused on competitive sports. Little attention was paid to recreational activities, and the psychosocial consequences of activity restriction were seldom evaluated. Comprehensive consensus recommendations for sport eligibility evaluating all CHD types and stages of repair are needed. These should include competitive and recreational activities, use standardized classifications to grade disease severity, and address the consequences of restriction.

Prophylactic intra-aortic balloon pump in high-risk patients undergoing coronary artery bypass surgery: a meta-analysis of randomized controlled trials.

PubMed

Sá, Michel Pompeu B O; Ferraz, Paulo E; Escobar, Rodrigo R; Martins, Wendell N; Nunes, Eliobas O; Vasconcelos, Frederico P; Lima, Ricardo C

2012-11-01

The aim of this study was to assess the efficacy of a prophylactic intra-aortic balloon pump (IABP) in high-risk patients undergoing coronary artery bypass graft surgery. MEDLINE, EMBASE, CENTRAL/CCTR, SciELO, LILACS, Google Scholar, and reference lists of relevant articles were searched. We included only randomized controlled trials. Assessments for eligibility, relevance, and study validity and data extraction were performed in duplicate using prespecified criteria. Meta-analysis was carried out using fixed-effect and random-effect models. Seven publications fulfilled our eligibility criteria. There was no important statistical heterogeneity or publication bias among included studies. In total, 177 patients received prophylactic IABP and 168 did not. Overall relative risk (RR) for hospital mortality in patients treated with prophylactic IABP was 0.255 [95% confidence interval (CI), 0.122-0.533; P<0.001; same results for both effect models]. Pooled RR for postoperative low cardiac output syndrome was 0.206 (95% CI, 0.109-0.389; P<0.001) for the fixed-effect model and 0.219 (95% CI, 0.095-0.504; P<0.001) for the random-effect model. Patients treated with prophylactic IABP presented an overall difference in means for length of intensive care unit stay and hospital stay, which was lower than that in the control group (P<0.001 for both effect models). Only 7.4% (13/177) of patients who received prophylactic IABP developed complications at an insertion site, with no IABP-related death. This meta-analysis supports the use of prophylactic IABP in high-risk patients to reduce hospital mortality. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.

Listeria monocytogenes infection from foods prepared in a commercial establishment: a case-control study of potential sources of sporadic illness in the United States.

PubMed

Varma, Jay K; Samuel, Michael C; Marcus, Ruthanne; Hoekstra, Robert M; Medus, Carlota; Segler, Suzanne; Anderson, Bridget J; Jones, Timothy F; Shiferaw, Beletshachew; Haubert, Nicole; Megginson, Melanie; McCarthy, Patrick V; Graves, Lewis; Gilder, Thomas Van; Angulo, Frederick J

2007-02-15

Listeria monocytogenes has been estimated to cause >2500 illnesses and 500 deaths annually in the United States. Efforts to reduce foodborne listeriosis have focused on foods frequently implicated in outbreaks. Potential sources for L. monocytogenes infection not associated with outbreaks remain poorly understood. The Foodborne Diseases Active Surveillance Network conducts surveillance for culture-confirmed listeriosis at clinical laboratories in 9 states. After excluding outbreak-associated cases, we attempted to enroll eligible case patients with L. monocytogenes infection in a case-control study from 2000 through 2003. Control subjects were recruited through health care providers and were matched to case patients by state, age, and immunosuppression status. Data were collected about exposures occurring in the 4 weeks before specimen collection from the case patients. Of the 249 case patients with L. monocytogenes infection, only 12 (5%) had cases that were associated with outbreaks; 6 other patients were ineligible for other reasons. Of 231 eligible case patients, 169 (73%) were enrolled in the study. We classified 28 case patients as having pregnancy-associated cases. We enrolled 376 control subjects. In multivariable analysis, L. monocytogenes infection was associated with eating melons at a commercial establishment (odds ratio, 2.6; 95% confidence interval, 1.4-5.0) and eating hummus prepared in a commercial establishment (odds ratio, 5.7; 95% confidence interval, 1.7-19.1). Most cases of L. monocytogenes infection were not associated with outbreaks. Reducing the burden of foodborne listeriosis may require interventions directed at retail environments and at foods, such as melons and hummus, that are not commonly recognized as high risk. Because of the severity of listeriosis, pregnant women and other persons at risk may wish to avoid eating these newly implicated foods.

Safety and Efficacy of Baricitinib Through 128 Weeks in an Open-label, Longterm Extension Study in Patients with Rheumatoid Arthritis.

PubMed

Keystone, Edward C; Genovese, Mark C; Schlichting, Douglas E; de la Torre, Inmaculada; Beattie, Scott D; Rooney, Terence P; Taylor, Peter C

2018-01-01

To assess the safety and efficacy of baricitinib in patients with rheumatoid arthritis (RA) up to 128 weeks in a phase IIb study (NCT01185353). After a 24-week blinded period, eligible patients entered an initial 52-week open-label extension (OLE); patients receiving 8 mg once daily (QD) continued with that dose and all others received 4 mg QD. Doses could be escalated to 8 mg QD at 28 or 32 weeks at investigator discretion when ≥ 6 tender and ≥ 6 swollen joints were present. Patients completing the first OLE were eligible to enter a second 52-week OLE and receive 4 mg QD regardless of previous dose. In the 4-mg (n = 108) and 8-mg (n = 93) groups, treatment-emergent adverse events (AE) occurred in 63% and 67%, serious AE in 16% and 13%, infections in 35% and 40%, and serious infections in 5% and 3% of patients, respectively. Exposure-adjusted incidence rates for AE for all baricitinib groups in the second OLE were similar to or lower than rates observed in the first OLE. No opportunistic infections, tuberculosis cases, or lymphomas were observed through 128 weeks; 1 death occurred during the first OLE. Among all patients in both OLE, the proportions who achieved disease improvement at Week 24 were similar or increased at weeks 76 and 128. In a phase IIb study in RA, the safety and tolerability profile of baricitinib, up to 128 weeks, remained consistent with earlier observations, without unexpected late signals. Clinical improvements seen in the 24-week blinded period were maintained during the OLE.

A bioprosthetic total artificial heart for end-stage heart failure: Results from a pilot study.

PubMed

Latrémouille, Christian; Carpentier, Alain; Leprince, Pascal; Roussel, Jean-Christian; Cholley, Bernard; Boissier, Elodie; Epailly, Eric; Capel, Antoine; Jansen, Piet; Smadja, David M

2018-01-01

The electro-hydraulically actuated Carmat total artificial heart (C-TAH) is designed to replace the heart in patients with end-stage heart failure, either as bridge to transplant or destination therapy. It provides pulsatile flow and contains bio-prosthetic blood contacting materials. A clinical feasibility study was conducted to evaluate the C-TAH safety and performance. Hospitalized patients, at imminent risk of death from irreversible biventricular failure despite optimal medical management, and not eligible for transplant or eligible but on extracorporeal life support, were enrolled. The primary endpoint was 30-days survival. Four patients were implanted with the C-TAH, three as destination therapy (ages 76, 68, 74) and one as bridge to transplant (age 58). They had implant times of 74, 270, 254 and 20 days respectively. All patients were free from hemolysis, clinical neurologic events, clinical evidence of thrombus and device-related infections. Hemodynamic and physical recovery allowed two patients to be discharged home for a cumulative duration of 7 months. The anticoagulation management strategy comprised initial unfractionated heparin, from postoperative day 2, followed by low molecular weight heparin and aspirin. An increased D-dimer level was observed in all patients during months 1 to 4. Temporary suspension of heparin anticoagulation resulted in thrombocytopenia and increased fibrin monomer, reversed by resuming anticoagulation with heparin. Causes of death were device-related (2 cases), respiratory failure and multi-organ failure. Preliminary clinical results with the C-TAH demonstrated good safety and performance profiles in patients suffering from biventricular failure, which need to be confirmed in a pivotal study. Copyright © 2018 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Determinants of hospital-to-nursing home placement delays: a pilot study.

PubMed Central

Weissert, W G; Cready, C M

1988-01-01

Estimates of hospital-to-nursing home placement delays have always been varied, and given Medicare's new Prospective Payment System (PPS) based on diagnosis-related groups (DRGs), they are likely to have changed again. Theory and previous research suggest that four patient characteristics are the main causes of delays: Medicaid as the patient's nursing home payer source; need for heavy care due to major physical or mental problems; admission to the hospital from a nursing home; and lack of social support. A pilot study of all 1,016 elderly awaiting nursing home placement in two admission cohorts (pre- and post-PPS) from the three largest hospitals in the county surrounding Charlotte, North Carolina--where nursing home beds are in short supply--indicates that other factors are more important. While most placements were delayed, delays were short. Multiple regression results show that Medicaid patients' delays were only about a day longer than those of private-pay patients. Of the many heavy-care conditions studied, only three were associated with delay. Patients without social support and patients admitted from a nursing home, discharged to a hospital-affiliated facility, or placed after PPS had shorter delays. Long delays were found among patients who had applied for Medicaid coverage but had not yet been certified as financially eligible. Nonwhites and males were also delayed. These findings, if replicated in other areas with perceived nursing home bed shortages, appear to have important implications not only for the usefulness of nursing home case-mix reimbursement and subacute levels of nursing home care, but for nursing home bed-need estimates, too, as well as for Medicaid eligibility determination practices and civil rights law enforcement. PMID:3060449

Modified Framingham Risk Factor Score for Systemic Lupus Erythematosus.

PubMed

Urowitz, Murray B; Ibañez, Dominique; Su, Jiandong; Gladman, Dafna D

2016-05-01

The traditional Framingham Risk Factor Score (FRS) underestimates the risk for coronary artery disease (CAD) in patients with systemic lupus erythematosus (SLE). We aimed to determine whether an adjustment to the FRS would more accurately reflect the higher prevalence of CAD among patients with SLE. Patients with SLE without a previous history of CAD or diabetes followed regularly at the University of Toronto Lupus Clinic were included. A modified FRS (mFRS) was calculated by multiplying the items by 1.5, 2, 3, or 4. In the first part of the study, using one-third of all eligible patients, we evaluated the sensitivity and specificity of the FRS and the different multipliers for the mFRS. In the second part of the study, using the remaining 2/3 of the eligible patients, we compared the predictive ability of the FRS to the mFRS. In the third part of the study, we assessed the prediction for CAD in a time-dependent analysis of the FRS and mFRS. There were 905 women (89.3%) with a total of 95 CAD events included. In part 1, we determined that a multiplier of 2 provided the best combination of sensitivity and specificity. In part 2, 2.4% of the patients were classified as moderate/high risk based on the classic FRS and 17.3% using the 2FRS (the FRS with a multiplier of 2). In part 3, a time-dependent covariate analysis for the prediction of the first CAD event revealed an HR of 3.22 (p = 0.07) for the classic FRS and 4.37 (p < 0.0001) for the 2FRS. An mFRS in which each item is multiplied by 2 more accurately predicts CAD in patients with SLE.

Monte Carlo Simulation Modeling of a Regional Stroke Team's Use of Telemedicine.

PubMed

Torabi, Elham; Froehle, Craig M; Lindsell, Christopher J; Moomaw, Charles J; Kanter, Daniel; Kleindorfer, Dawn; Adeoye, Opeolu

2016-01-01

The objective of this study was to evaluate operational policies that may improve the proportion of eligible stroke patients within a population who would receive intravenous recombinant tissue plasminogen activator (rt-PA) and minimize time to treatment in eligible patients. In the context of a regional stroke team, the authors examined the effects of staff location and telemedicine deployment policies on the timeliness of thrombolytic treatment, and estimated the efficacy and cost-effectiveness of six different policies. A process map comprising the steps from recognition of stroke symptoms to intravenous administration of rt-PA was constructed using data from published literature combined with expert opinion. Six scenarios were investigated: telemedicine deployment (none, all, or outer-ring hospitals only) and staff location (center of region or anywhere in region). Physician locations were randomly generated based on their zip codes of residence and work. The outcomes of interest were onset-to-treatment (OTT) time, door-to-needle (DTN) time, and the proportion of patients treated within 3 hours. A Monte Carlo simulation of the stroke team care-delivery system was constructed based on a primary data set of 121 ischemic stroke patients who were potentially eligible for treatment with rt-PA. With the physician located randomly in the region, deploying telemedicine at all hospitals in the region (compared with partial or no telemedicine) would result in the highest rates of treatment within 3 hours (80% vs. 75% vs. 70%) and the shortest OTT (148 vs. 164 vs. 176 minutes) and DTN (45 vs. 61 vs. 73 minutes) times. However, locating the on-call physician centrally coupled with partial telemedicine deployment (five of the 17 hospitals) would be most cost-effective with comparable eligibility and treatment times. Given the potential societal benefits, continued efforts to deploy telemedicine appear warranted. Aligning the incentives between those who would have to fund the up-front technology investments and those who will benefit over time from reduced ongoing health care expenses will be necessary to fully realize the benefits of telemedicine for stroke care. © 2015 by the Society for Academic Emergency Medicine.

The use of DRG for identifying clinical trials centers with high recruitment potential: a feasability study.

PubMed

Aegerter, Philippe; Bendersky, Noelle; Tran, Thi-Chien; Ropers, Jacques; Taright, Namik; Chatellier, Gilles

2014-01-01

Recruitment of large samples of patients is crucial for evidence level and efficacy of clinical trials (CT). Clinical Trial Recruitment Support Systems (CTRSS) used to estimate patient recruitment are generally specific to Hospital Information Systems and few were evaluated on a large number of trials. Our aim was to assess, on a large number of CT, the usefulness of commonly available data as Diagnosis Related Groups (DRG) databases in order to estimate potential recruitment. We used the DRG database of a large French multicenter medical institution (1.2 million inpatient stays and 400 new trials each year). Eligibility criteria of protocols were broken down into in atomic entities (diagnosis, procedures, treatments...) then translated into codes and operators recorded in a standardized form. A program parsed the forms and generated requests on the DRG database. A large majority of selection criteria could be coded and final estimations of number of eligible patients were close to observed ones (median difference = 25). Such a system could be part of the feasability evaluation and center selection process before the start of the clinical trial.

The Kidney and Periodontal Disease (KAPD) study: A pilot randomized controlled trial testing the effect of non-surgical periodontal therapy on chronic kidney disease.

PubMed

Grubbs, Vanessa; Garcia, Faviola; Jue, Bonnie L; Vittinghoff, Eric; Ryder, Mark; Lovett, David; Carrillo, Jacqueline; Offenbacher, Steven; Ganz, Peter; Bibbins-Domingo, Kirsten; Powe, Neil R

2017-02-01

Chronic kidney disease (CKD) remains a prevalent public health problem that disproportionately affects minorities and the poor, despite intense efforts targeting traditional risk factors. Periodontal diseases are common bacterial plaque-induced inflammatory conditions that can respond to treatment and have been implicated as a CKD risk factor. However there is limited evidence that treatment of periodontal disease slows the progression of CKD. We describe the protocol of the Kidney and Periodontal Disease (KAPD) study, a 12-month un-blinded, randomized, controlled pilot trial with two intent-to-treat treatment arms: 1. immediate intensive non-surgical periodontal treatment or 2. rescue treatment with delayed intensive treatment. The goals of this pilot study are to test the feasibility of conducting a larger trial in an ethnically and racially diverse, underserved population (mostly poor and/or low literacy) with both CKD and significant periodontal disease to determine the effect of intensive periodontal treatment on renal and inflammatory biomarkers over a 12-month period. To date, KAPD has identified 634 potentially eligible patients who were invited to in-person screening. Of the 83 (13.1%) of potentially eligible patients who attended in-person screening, 51 (61.4%) were eligible for participation and 46 enrolled in the study. The mean age of participants is 59.2years (range 34 to 73). Twenty of the participants (43.5%) are Black and 22 (47.8%) are Hispanic. Results from the KAPD study will provide needed preliminary evidence of the effectiveness of non-surgical periodontal treatment to slow CKD progression and inform the design future clinical research trials. Copyright © 2016. Published by Elsevier Inc.

Systematic literature review: xerostomia in advanced cancer patients.

PubMed

Hanchanale, Sarika; Adkinson, Lucy; Daniel, Sunitha; Fleming, Michelle; Oxberry, Stephen G

2015-03-01

Dry mouth (xerostomia) is one of the commonest symptoms in cancer patients and can adversely affect quality of life. The aim of this review was to determine the effectiveness of pharmacological and non-pharmacological interventions in treating xerostomia in adult advanced cancer patients. The literature search was performed in February 2014 using databases including EMBASE, MEDLINE, CINAHL, BNI and Cochrane library. The search was carried out using standard MeSH terms and was limited to adult population and English language. Studies investigating xerostomia secondary to head and neck cancer treatment and autoimmune disease were excluded. Titles and abstracts were screened and reviewed for eligibility. Only studies involving primary research were included in the analysis. Six studies met the eligibility criteria for review: three randomized controlled trials and three prospective studies. The quality assessment and reporting was performed using PRISMA, Jadad and STROBE. These studies compared acupuncture, pilocarpine, Saliva Orthana and chewing gum with each other or with placebo. All interventions were considered effective in treating xerostomia. However, effectiveness versus placebo could not be demonstrated for Saliva Orthana. Meta-analysis could not be performed due to heterogeneity of the study type and intervention. Limited published data exists reporting the effectiveness of measures in the treatment of xerostomia in cancer patients. Based on primary research of low quality, firm conclusions cannot be drawn. However, pilocarpine, artificial saliva, chewing gum and acupuncture can be tried based on the available data. This highlights the explicit need to improve our evidence base. Properly constructed randomized controlled trials demonstrating effectiveness of pharmacological and non-pharmacological interventions for dry mouth are required.

Comparative safety and effectiveness of cognitive enhancers for Alzheimer's dementia: protocol for a systematic review and individual patient data network meta-analysis

PubMed Central

Veroniki, Areti Angeliki; Straus, Sharon E; Ashoor, Huda M; Hamid, Jemila S; Hemmelgarn, Brenda R; Holroyd-Leduc, Jayna; Majumdar, Sumit R; McAuley, Glenn; Tricco, Andrea C

2016-01-01

Introduction Alzheimer's dementia (AD) is the most common cause of dementia, and several organisations, such as the National Institute for Health and Care Excellence, suggest that management of patients with AD should be tailored to their needs. To date, little research has been conducted on the treatment effect in different subgroups of patients with AD. The aim of this study is to examine the comparative effectiveness and safety of cognitive enhancers for different patient characteristics. Methods and analysis We will update our previous literature search from January 2015 forward, using the same terms and electronic databases (eg, MEDLINE) from our previous review. We will additionally search grey literature and scan the reference lists of the included studies. Randomised clinical trials of any duration conducted at any time comparing cognitive enhancers alone or in any combination against other cognitive enhancers, or placebo in adults with AD will be eligible. The outcomes of interest are cognition according to the Mini-Mental State Examination, and overall serious adverse events. For each outcome and treatment comparison, we will perform a Bayesian hierarchical random-effects meta-analysis combining the individual patient data (IPD) from each eligible study. If the identified treatment comparisons form a connected network diagram, we will perform an IPD network meta-analysis (NMA) to estimate subgroup effects for patients with different characteristics, such as AD severity and sex. We will combine aggregated data from studies that we will not be able to obtain IPD, with the IPD provided by the original authors, in a single model. We will use the PRISMA-IPD and PRISMA-NMA statements to report our findings. Ethics and dissemination The findings of this study will be of interest to stakeholders, including decision makers, guideline developers, clinicians, methodologists and patients, and they will help to improve guidelines for the management of patients with AD. Trial registration number CRD42015023507. PMID:26769792

Study Design and Rationale for a Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Selumetinib in Combination With Docetaxel as Second-Line Treatment in Patients With KRAS-Mutant Advanced Non-Small Cell Lung Cancer (SELECT-1).

PubMed

Jänne, Pasi A; Mann, Helen; Ghiorghiu, Dana

2016-03-01

Oncogenic KRAS mutations represent the largest genomically defined subset of lung cancer, and are associated with activation of the RAS/RAF/MEK/ERK pathway. There are currently no therapies specifically approved for patients with KRAS-mutant (KRASm) non-small-cell lung cancer (NSCLC), and these patients derive less clinical benefit from chemotherapy than the overall NSCLC population. In a recent phase II study, selumetinib (AZD6244, ARRY-142886), an oral, potent and selective, allosteric MEK1/2 inhibitor with a short half-life, combined with docetaxel, improved clinical outcome as second-line treatment for patients with KRASm NSCLC. This combination will be further evaluated in the phase III SELECT-1 study. SELECT-1 (NCT01933932) is a randomized, double-blind, placebo-controlled phase III study assessing the efficacy and safety of selumetinib plus docetaxel in patients with KRASm locally advanced or metastatic NSCLC, eligible for second-line treatment. The primary endpoint is progression-free survival (PFS); secondary endpoints include overall survival, objective response rate, duration of response, and safety and tolerability. Approximately 634 patients will be randomized 1:1 to receive selumetinib (75 mg twice daily on a continuous oral administration schedule) in combination with docetaxel (75 mg/m(2), intravenously on day 1 of every 21-day cycle) or placebo in combination with docetaxel (same schedule), until objective disease progression. Patients may continue to receive treatment after objective disease progression if deemed appropriate by the investigator. If the primary endpoint of PFS is met, selumetinib plus docetaxel would be the first targeted treatment for patients with KRASm advanced NSCLC who are eligible for second-line treatment. Copyright © 2016 Elsevier Inc. All rights reserved.

Concordance of hypervascular liver nodule characterization between the organ procurement and transplant network and liver imaging reporting and data system classifications.

PubMed

Bashir, Mustafa R; Huang, Rong; Mayes, Nicholas; Marin, Daniele; Berg, Carl L; Nelson, Rendon C; Jaffe, Tracy A

2015-08-01

To determine the rate of agreement between the Organ Procurement and Transplant Network (OPTN) and Liver Imaging Reporting and Data System (LI-RADS) classifications for hypervascular liver nodules at least 1 cm in diameter, and for patient eligibility for hepatocellular/MELD (Model for Endstage Liver Disease) exception points. This retrospective study was approved by our Institutional Review Board and was compliant with the Health Insurance Portability and Accountability Act. The requirement for informed consent was waived. This study included 200 hypervascular hepatocellular nodules at least 1 cm in diameter on computed tomography (CT) or magnetic resonance imaging (MRI) examinations in 105 patients with chronic liver disease. Three radiologists blinded to clinical data independently evaluated nodule characteristics, including washout, capsule, size, and size on prior examination. Based on those characteristics, nodules were automatically classified as definite hepatocellular carcinoma (HCC) or not definite HCC using both the OPTN and LI-RADS classifications. Using these classifications and the Milan criteria, each examination was determined to be "below transplant criteria," "within transplant criteria," or "beyond transplant criteria." Agreement was assessed between readers and classification systems, using Fleiss' kappa, intraclass correlation coefficients (ICCs), and simple proportions. Interreader agreement was moderate for nodule features (κ = 0.59-0.69) and nodule classification (0.66-0.69). The two systems were in nearly complete agreement on nodule category assignment (98.7% [592/600]) and patient eligibility for transplant exemption priority (99.4% [313/315]). A few discrepancies occurred for the nodule feature of growth (1.3% [8/600]) and for nodule category assignment (1.3% [8/600]). Agreement between the OPTN and LI-RADS classifications is very strong for categorization of hypervascular liver nodules at least 1 cm in diameter, and for patient eligibility for hepatocellular/MELD exception points. Interreader variability is much higher than intersystem variability. © 2014 Wiley Periodicals, Inc.

Physician awareness of enhanced prenatal services for medicaid-insured pregnant women.

PubMed

Raffo, Jennifer E; Gary, Monica; Forde, Gareth K; Meghea, Cristian I; Roman, Lee Anne

2014-01-01

Medicaid enhanced prenatal service (EPS) programs, including care coordination, were developed to improve birth outcomes for low-income pregnant women. In Michigan, less than a third of eligible pregnant women are enrolled in services. Physician or medical clinics provide referrals to community-based EPS. The objective of this study was to examine physician knowledge and perceptions of EPS. A cross-sectional survey of obstetric providers was conducted in 2009. A questionnaire was created to assess understanding of the EPS program. The study was conducted in an urban Michigan community. Participants included a convenience sample (N = 56) of community Obstetrics and Gynecology attending physicians and resident physicians within a single, large health system. Outcome measures included knowledge of the program and patient participation, referral practices, perceptions of the program, value for patients and providers, appropriateness of physicians to provide program referrals, and barriers to referring. Findings indicated that most physicians (84%) had little familiarity with EPS, 60% did not personally refer to EPS, 54% did not know whether other office staff referred to EPS, and 65% were unaware whether their patients received EPS. Yet, more than 90% of physicians reported that EPS would benefit their patients and believed that it was appropriate for them to refer all their eligible patients. Further efforts should be made to better understand how physicians and EPS providers could function together on behalf of patients. Statewide Medicaid-sponsored EPS programs could serve as a valuable patient and physician resource for psychosocial risk screening, care management, education, and referral support if better utilized.

PCSK9 Inhibitors Show Value for Patients and the US Health Care System.

PubMed

Cheng, Wei-Han; Gaudette, Étienne; Goldman, Dana P

2017-12-01

Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors were approved by the US Food and Drug Administration (FDA) as cholesterol-lowering therapies for patients with familial hypercholesterolemia or atherosclerotic cardiovascular disease. To estimate the long-term health and economic value of PCSK9 inhibitors for Americans (51 years and older). We conducted simulations using the Future Elderly Model, an established dynamic microsimulation model to project the lifetime outcomes for the US population aged 51 years and older. Health effects estimates and confidence intervals from published meta-analysis studies were used to project changes in life expectancy, quality-adjusted life-years, and lifetime medical spending resulting from the use of PCSK9 inhibitors. We considered two treatment scenarios: 1) current FDA eligibility and 2) an extended eligibility scenario that includes patients with no pre-existing cardiovascular disease but at high risk. We assumed that the price of PCSK9 inhibitors was discounted by 35% in the first 12 years and by 57% thereafter, with gradual uptake of the drug in eligible populations. Use of PCSK9 inhibitors by individuals covered by current FDA approval would extend life expectancy at the age of 51 years by an estimated 1.1 years and would yield a lifetime net value of $5800 per person. If use was extended to those at high risk for cardiovascular disease, PCSK9 inhibitors would generate a lifetime net benefit of $14,100 per person. Expanded access to PCSK9 inhibitors would offer positive long-term net value for patients and the US health care system at the current discounted prices. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Medicaid enrollment after liver transplantation: Effects of medicaid expansion.

PubMed

Tumin, Dmitry; Hayes, Don; Washburn, W Kenneth; Tobias, Joseph D; Black, Sylvester M

2016-08-01

Liver transplantation (LT) recipients in the United States have low rates of paid employment, making some eligible for Medicaid public health insurance after transplant. We test whether recent expansions of Medicaid eligibility increased Medicaid enrollment and insurance coverage in this population. Patients of ages 18-59 years receiving first-time LTs in 2009-2013 were identified in the United Network for Organ Sharing registry and stratified according to insurance at transplantation (private versus Medicaid/Medicare). Posttransplant insurance status was assessed through June 2015. Difference-in-difference multivariate competing-risks models stratified on state of residence estimated effects of Medicaid expansion on Medicaid enrollment or use of uninsured care after LT. Of 12,837 patients meeting inclusion criteria, 6554 (51%) lived in a state that expanded Medicaid eligibility. Medicaid participation after LT was more common in Medicaid-expansion states (25%) compared to nonexpansion states (19%; P < 0.001). Multivariate analysis of 7279 patients with private insurance at transplantation demonstrated that after the effective date of Medicaid expansion (January 1, 2014), the hazard of posttransplant Medicaid enrollment increased in states participating in Medicaid expansion (hazard ratio [HR] = 1.5; 95% confidence interval [CI] = 1.1-2.0; P = 0.01), but not in states opting out of Medicaid expansion (HR = 0.8; 95% CI = 0.5-1.3; P = 0.37), controlling for individual characteristics and time-invariant state-level factors. No effects of Medicaid expansion on the use of posttransplant uninsured care were found, regardless of private or government insurance status at transplantation. Medicaid expansion increased posttransplant Medicaid enrollment among patients who had private insurance at transplantation, but it did not improve overall access to health insurance among LT recipients. Liver Transplantation 22 1075-1084 2016 AASLD. © 2016 American Association for the Study of Liver Diseases.

Nivolumab with or without ipilimumab treatment for metastatic sarcoma (Alliance A091401): two open-label, non-comparative, randomised, phase 2 trials.

PubMed

D'Angelo, Sandra P; Mahoney, Michelle R; Van Tine, Brian A; Atkins, James; Milhem, Mohammed M; Jahagirdar, Balkrishna N; Antonescu, Cristina R; Horvath, Elise; Tap, William D; Schwartz, Gary K; Streicher, Howard

2018-03-01

Patients with metastatic sarcoma have limited treatment options. Nivolumab and ipilimumab are monoclonal antibodies targeting PD-1 and CTLA-4, respectively. We investigated the activity and safety of nivolumab alone or in combination with ipilimumab in patients with locally advanced, unresectable, or metastatic sarcoma. We did a multicentre, open-label, non-comparative, randomised, phase 2 study that enrolled patients aged 18 years or older and had central pathology confirmation of sarcoma with at least one measurable lesion by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, evidence of metastatic, locally advanced or unresectable disease, an ECOG performance status of 0-1, and received at least one previous line of systemic therapy. Patients were assigned to treatment in an unblinded manner, as this trial was conducted as two independent, non-comparative phase 2 trials. Enrolled patients were assigned (1:1) via a dynamic allocation algorithm to intravenous nivolumab 3 mg/kg every 2 weeks, or nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for four doses. Thereafter, all patients received nivolumab monotherapy (3 mg/kg) every 2 weeks for up to 2 years. The primary endpoint was the proportion of patients with locally advanced, unresectable or metastatic soft tissue sarcoma achieving a confirmed objective response. Analysis was per protocol. This study is ongoing although enrolment is closed. It is registered with ClinicalTrials.gov, number NCT02500797. Between Aug 13, 2015, and March 17, 2016, 96 patients from 15 sites in the USA underwent central pathology review for eligibility and 85 eligible patients, including planned over-enrolment, were allocated to receive either nivolumab monotherapy (43 patients) or nivolumab plus ipilimumab (42 patients). The primary endpoint analysis was done according to protocol specifications in the first 76 eligible patients (38 patients per group). The number of confirmed responses was two (5% [92% CI 1-16] of 38 patients) in the nivolumab group and six (16% [7-30] of 38 patients) in the nivolumab plus ipilimumab group. The most common grade 3 or worse adverse events were anaemia (four [10%] patients), decreased lymphocyte count (three [7%]), and dehydration, increased lipase, pain, pleural effusion, respiratory failure, secondary benign neoplasm, and urinary tract obstruction (two [5%] patients each) among the 42 patients in the nivolumab group and anaemia (eight [19%] patients), hypotension (four [10%] patients), and pain and urinary tract infection (three [7%] patients each) among the 42 patients in the nivolumab plus ipilimumab group. Serious treatment-related adverse events occurred in eight (19%) of 42 patients receiving monotherapy and 11 (26%) of 42 patients receiving combination therapy, and included anaemia, anorexia, dehydration, decreased platelet count, diarrhoea, fatigue, fever, increased creatinine, increased alanine aminotransferase, increased aspartate aminotransferase, hyponatraemia, pain, pleural effusion, and pruritus. There were no treatment-related deaths. Nivolumab alone does not warrant further study in an unselected sarcoma population given the limited efficacy. Nivolumab combined with ipilimumab demonstrated promising efficacy in certain sarcoma subtypes, with a manageable safety profile comparable to current available treatment options. The combination therapy met its predefined primary study endpoint; further evaluation of nivolumab plus ipilimumab in a randomised study is warranted. Alliance Clinical Trials in Oncology, National Cancer Institute Cancer Therapy Evaluation Program, Bristol-Myers Squibb, Cycle for Survival. Copyright © 2018 Elsevier Ltd. All rights reserved.

The quality of systematic reviews about interventions for refractive error can be improved: a review of systematic reviews.

PubMed

Mayo-Wilson, Evan; Ng, Sueko Matsumura; Chuck, Roy S; Li, Tianjing

2017-09-05

Systematic reviews should inform American Academy of Ophthalmology (AAO) Preferred Practice Pattern® (PPP) guidelines. The quality of systematic reviews related to the forthcoming Preferred Practice Pattern® guideline (PPP) Refractive Errors & Refractive Surgery is unknown. We sought to identify reliable systematic reviews to assist the AAO Refractive Errors & Refractive Surgery PPP. Systematic reviews were eligible if they evaluated the effectiveness or safety of interventions included in the 2012 PPP Refractive Errors & Refractive Surgery. To identify potentially eligible systematic reviews, we searched the Cochrane Eyes and Vision United States Satellite database of systematic reviews. Two authors identified eligible reviews and abstracted information about the characteristics and quality of the reviews independently using the Systematic Review Data Repository. We classified systematic reviews as "reliable" when they (1) defined criteria for the selection of studies, (2) conducted comprehensive literature searches for eligible studies, (3) assessed the methodological quality (risk of bias) of the included studies, (4) used appropriate methods for meta-analyses (which we assessed only when meta-analyses were reported), (5) presented conclusions that were supported by the evidence provided in the review. We identified 124 systematic reviews related to refractive error; 39 met our eligibility criteria, of which we classified 11 to be reliable. Systematic reviews classified as unreliable did not define the criteria for selecting studies (5; 13%), did not assess methodological rigor (10; 26%), did not conduct comprehensive searches (17; 44%), or used inappropriate quantitative methods (3; 8%). The 11 reliable reviews were published between 2002 and 2016. They included 0 to 23 studies (median = 9) and analyzed 0 to 4696 participants (median = 666). Seven reliable reviews (64%) assessed surgical interventions. Most systematic reviews of interventions for refractive error are low methodological quality. Following widely accepted guidance, such as Cochrane or Institute of Medicine standards for conducting systematic reviews, would contribute to improved patient care and inform future research.

ILM peeling in nontractional diabetic macular edema: review and metanalysis.

PubMed

Rinaldi, M; dell'Omo, R; Morescalchi, F; Semeraro, F; Gambicorti, E; Cacciatore, F; Chiosi, F; Costagliola, C

2017-10-31

To evaluate the effect of internal limiting membrane (ILM) peeling during vitrectomy for nontractional diabetic macular edema. PUBMED, MEDLINE and CENTRAL were reviewed using the following terms (or combination of terms): diabetic macular edema, nontractional diabetic macular edema, internal limiting membrane peeling, vitrectomy, Müller cells. Randomized and nonrandomized studies were included. The eligible studies compared anatomical and functional outcomes of vitrectomy with or without ILM peeling for tractional and nontractional diabetic macular edema. Postoperative best-corrected visual acuity and central macular thickness were considered, respectively, the primary and secondary outcomes. Meta-analysis on mean differences between vitrectomy with and without ILM peeling was performed using inverse variance method in random effects. Four studies with 672 patients were eligible for analysis. No significant difference was found between postoperative best-corrected visual acuity or best-corrected visual acuity change of ILM peeling group compared with nonpeeling group. There was no significant difference in postoperative central macular thickness and central macular thickness reduction between the two groups. The visual acuity outcomes in patients affected by nontractional diabetic macular edema using pars plana vitrectomy with ILM peeling versus no ILM peeling were not significantly different. A larger prospective and randomized study would be necessary.

An Electronic Medical Record Alert Intervention to Improve HPV Vaccination Among Eligible Male College Students at a University Student Health Center.

PubMed

Martin, Suzanne; Warner, Echo L; Kirchhoff, Anne C; Mooney, Ryan; Martel, Laura; Kepka, Deanna

2018-02-16

This pilot study aims to improve HPV vaccination for college aged males at a student health center. The first part of the study consisted of a focus group that assessed the barriers and facilitators of HPV vaccination among healthcare providers and clinic staff (N = 16). Providers reported missed opportunities for HPV vaccination. For the second part of the study, providers and staff reviewed medical records of patients ages 18-26 with student health insurance and with < 3 doses of the HPV vaccine at baseline (12/1/2014 to 7/31/2015) and follow-up (12/1/2015 to 7/31/2016). A computer-automated EMR alert was generated in the medical record of eligible male patients (N = 386). Z-scores were estimated for two-sample proportions to measure change in HPV vaccine rates at baseline and follow-up for males and females. HPV vaccine initiation rates increased among males (baseline: 5.2% follow-up: 25.1%, p < 0.001). This study shows that EMR alerts improved HPV vaccine initiation rates among insured college-aged males.

Effect of a Motivational Interviewing-Based Health Coaching on Quality of Life in Subjects With COPD.

PubMed

Rehman, Hamid; Karpman, Craig; Vickers Douglas, Kristin; Benzo, Roberto P

2017-08-01

Improving quality of life (QOL) is a key goal in the care of patients with COPD. Pulmonary rehabilitation (PR) has clearly been shown to improve QOL, but is not accessible to many eligible patients. There is a need for alternative programs designed to improve patient well-being that are accessible to all patients with COPD. Our goal was to pilot test a simple, telephone-based health-coaching intervention that was recently shown to decrease readmission among hospitalized COPD patients and stable COPD patients eligible for PR. Subjects received a 3-month intervention consisting of 10 health-coaching telephone calls based on motivational interviewing principles. Outcome measures included dyspnea level, measured by the modified Medical Research Council scale, and QOL, measured by the Chronic Respiratory Questionnaire and a single-item general self-rated health status. Fifty subjects with moderate to severe COPD were enrolled in the study. Forty-four subjects (86%) completed the study intervention. Dyspnea measured by the modified Medical Research Council score improved significantly after the intervention ( P = .002). The domains of fatigue, emotional function, and mastery on the Chronic Respiratory Disease Questionnaire and the single-item QOL question also improved significantly after the 3 months of health coaching ( P = .001, P = .001, P = .007, and P = .03, respectively). Thirty-six (71%) subjects had a clinically meaningful improvement in at least 1 study end point (either in the severity of dyspnea or a domain of QOL). Thirty subjects (58%) had an improvement of ≥0.5 points, the minimum clinically important difference in at least 1 component of the Chronic Respiratory Disease Questionnaire. A telephone-delivered motivational interviewing-based coaching program for COPD patients is a feasible, well-accepted (by both participants and providers), simple, and novel intervention to improve the well-being of patients with COPD. This pilot study provides insight into a possible alternative to a conventional PR program for patients with limited access to that program. Copyright © 2017 by Daedalus Enterprises.

Weekly Carboplatin Reduces Toxicity During Synchronous Chemoradiotherapy for Merkel Cell Carcinoma of Skin

DOE Office of Scientific and Technical Information (OSTI.GOV)

Poulsen, Michael; Walpole, Euan; Harvey, Jennifer

Purpose: The toxicity of radiotherapy (RT) combined with weekly carboplatin and adjuvant carboplatin and etoposide was prospectively assessed in a group of patients with high-risk Stage I and II Merkel cell carcinoma of the skin. This regimen was compared with the Trans-Tasman Radiation Oncology Group 96:07 study, which used identical eligibility criteria but carboplatin and etoposide every 3 weeks during RT. Patients and Methods: Patients were eligible if they had disease localized to the primary site and lymph nodes, with high-risk features. RT was delivered to the primary site and lymph nodes to a dose of 50 Gy and weeklymore » carboplatin (area under the curve of 2) was given during RT. This was followed by three cycles of carboplatin and etoposide. A total of 18 patients were entered into the study, and their data were compared with the data from 53 patients entered into the Trans-Tasman Radiation Oncology Group 96:07 study. Results: Involved lymph nodes (Stage II) were present in 14 patients (77%). Treatment was completed as planned in 16 patients. The weekly carboplatin dose was delivered in 17 patients, and 15 were able to complete all three cycles of adjuvant carboplatin and etoposide. Grade 3 and 4 neutrophil toxicity occurred in 7 patients, but no cases of febrile neutropenia developed. Compared with the Trans-Tasman Radiation Oncology Group 96:07 protocol (19 of 53 cases of febrile neutropenia), the reduction in the febrile neutropenia rate (p = 0.003) and decrease in Grade 3 skin toxicity (p = 0.006) were highly statistically significant. Conclusion: The results of our study have shown that weekly carboplatin at this dosage is a safe way to deliver synchronous chemotherapy during RT for MCC and results in a marked reduction of febrile neutropenia and Grade 3 skin toxicity compared with the three weekly regimen.« less

Prostate cancer family history and eligibility for active surveillance: a systematic review of the literature.

PubMed

Telang, Jaya M; Lane, Brian R; Cher, Michael L; Miller, David C; Dupree, James M

2017-10-01

Active surveillance (AS) is an increasingly prevalent treatment choice for low grade prostate cancer. Eligibility criteria for AS are varied and it is unclear if family history of prostate cancer should be used as an exclusion criterion when considering men for AS. To determine whether family history plays a significant role in the progression of prostate cancer for men undergoing active surveillance, PubMed searches of 'family history and prostate cancer', 'family history and prostate cancer progression' and 'factors of prostate cancer progression' were used to identify research publications about the relationship between family history and prostate cancer progression. These searches generated 536 papers that were screened and reviewed. Six publications were ultimately included in this analysis. Review of the six publications suggests that family history does not increase the risk of prostate cancer progression, whilst a subgroup analysis in one study found that family history increases the risk of prostate cancer progression only in African-Americans. A family history of prostate cancer does not appear to increase a patient's risk of having more aggressive prostate cancer and is therefore unlikely to be an important factor in determining eligibility for AS. Further studies are needed to better understand the relationship between race, family history, and eligibility for AS. © 2017 The Authors BJU International © 2017 BJU International Published by John Wiley & Sons Ltd.

Psychiatric Disorders and Mental Health Service Use in Patients with Advanced Cancer

PubMed Central

Kadan-Lottick, Nina S.; Vanderwerker, Lauren C.; Block, Susan D.; Zhang, Baohui; Prigerson, Holly G.

2006-01-01

BACKGROUND. Psychological morbidity has been proposed as a source of distress in cancer patients. This study aimed to: 1) determine the prevalence of diagnosable psychiatric illnesses, and 2) describe the mental health services received and predictors of service utilization in patients with advanced cancer. METHODS. This was a cross-sectional, multi-institutional study of 251 eligible patients with advanced cancer. Eligibility included: distant metastases, primary therapy failure, nonpaid caregiver, age ≥20 years, stamina for the interview, English or Spanish-speaking, and adequate cognitive ability. Trained interviewers administered the Structured Clinical Interview for the Diagnostic Statistical Manual IV (DSM-IV) modules for Major Depressive Disorder, Generalized Anxiety Disorder, Panic Disorder, Post-Traumatic Stress Disorder, and a detailed questionnaire regarding mental health service utilization. RESULTS. Overall, 12% met criteria for a major psychiatric condition and 28% had accessed a mental health intervention for a psychiatric illness since the cancer diagnosis. Seventeen percent had discussions with a mental health professional; 90% were willing to receive treatment for emotional problems. Mental health services were not accessed by 55% of patients with major psychiatric disorders. Cancer patients who had discussed psychological concerns with mental health staff (odds ratio [OR] = 19.2; 95% confidence interval [95% CI], 8.90-41.50) and non-Hispanic white patients (OR = 2.7; 95% CI, 1.01-7.43) were more likely to receive mental health services in adjusted analysis. CONCLUSIONS. Advanced cancer patients experience major psychiatric disorders at a prevalence similar to the general population, but affected individuals have a low rate of utilizing mental health services. Oncology providers can enhance utilization of mental health services, and potentially improve clinical outcomes, by discussing mental health concerns with their patients. PMID:16284994

Non-invasive versus invasive management in patients with prior coronary artery bypass surgery with a non-ST segment elevation acute coronary syndrome: study design of the pilot randomised controlled trial and registry (CABG-ACS)

PubMed Central

Lee, Matthew M Y; Petrie, Mark C; Rocchiccioli, Paul; Simpson, Joanne; Jackson, Colette; Brown, Ammani; Corcoran, David; Mangion, Kenneth; McEntegart, Margaret; Shaukat, Aadil; Rae, Alan; Hood, Stuart; Peat, Eileen; Findlay, Iain; Murphy, Clare; Cormack, Alistair; Bukov, Nikolay; Balachandran, Kanarath; Papworth, Richard; Ford, Ian; Briggs, Andrew; Berry, Colin

2016-01-01

Introduction There is an evidence gap about how to best treat patients with prior coronary artery bypass grafts (CABGs) presenting with non-ST segment elevation acute coronary syndromes (NSTE-ACS) because historically, these patients were excluded from pivotal randomised trials. We aim to undertake a pilot trial of routine non-invasive management versus routine invasive management in patients with NSTE-ACS with prior CABG and optimal medical therapy during routine clinical care. Our trial is a proof-of-concept study for feasibility, safety, potential efficacy and health economic modelling. We hypothesise that a routine invasive approach in patients with NSTE-ACS with prior CABG is not superior to a non-invasive approach with optimal medical therapy. Methods and analysis 60 patients will be enrolled in a randomised clinical trial in 4 hospitals. A screening log will be prospectively completed. Patients not randomised due to lack of eligibility criteria and/or patient or physician preference and who give consent will be included in a registry. We will gather information about screening, enrolment, eligibility, randomisation, patient characteristics and adverse events (including post-discharge). The primary efficacy outcome is the composite of all-cause mortality, rehospitalisation for refractory ischaemia/angina, myocardial infarction and hospitalisation for heart failure. The primary safety outcome is the composite of bleeding, stroke, procedure-related myocardial infarction and worsening renal function. Health status will be assessed using EuroQol 5 Dimensions (EQ-5D) assessed at baseline and 6 monthly intervals, for at least 18 months. Trial registration number NCT01895751 (ClinicalTrials.gov). PMID:27110377

Recruitment of Older Adult Patient-Caregiver Dyads for an Online Caregiver Resource Program: Lessons Learned.

PubMed

Nahm, Eun-Shim; Orwig, Denise; Resnick, Barbara; Magaziner, Jay; Bellantoni, Michele; Sterling, Robert

2012-01-12

Hip fracture is a significant health problem for older adults and generally requires surgery followed by intensive rehabilitation. Informal caregivers (CGs) can provide vital assistance to older adults recovering from hip fracture. Caregiving is a dyadic process that affects both CGs and care recipients (CRs). In a feasibility study, we assessed the effects of using a theory-based online hip fracture resource program for CGs on both CGs and CRs. In this article, we discuss our recruitment process and the lessons learned. Participants were recruited from six acute hospitals, and CGs used the online resource program for 8 weeks. A total of 256 hip fracture patients were screened, and 164 CRs were ineligible. CG screening was initiated when CRs were determined to be eligible. Among 41 eligible dyads, 36 dyads were recruited. Several challenges to the recruitment of these dyads for online studies were identified, including a low number of eligible dyads in certain hospitals and difficulty recruiting both the CR and the CG during the short hospital stay. Field nurses often had to make multiple trips to the hospital to meet with both the CR and the CG. Thus, when a subject unit is a dyad recruited from acute settings, the resources required for the recruitment may be more than doubled. These challenges could be successfully alleviated with careful planning, competent field staff members, collaboration with hospital staff members, and efficient field operations.

A New Method to Directly Observe Tuberculosis Treatment: Skype Observed Therapy, a Patient-Centered Approach.

PubMed

Buchman, Tavora; Cabello, Celina

Tuberculosis (TB) treatment completion is in part determined by patient's adherence to long-term drug regimens. To best ensure compliance, directly observed therapy (DOT) is considered the standard of practice. Nassau County Department of Health TB Control is responsible for providing DOT to patients with TB. Tuberculosis Control sought to use and evaluate Skype Observed Therapy (SOT) as an alternative to DOT for eligible patients. The evaluation included analysis of patient's acceptance and adherence to drug regimen using SOT. Tuberculosis Control assessed staff efficiency and cost savings for this program. Percentages of SOT of patients and successful SOT visits, mileage, and travel time savings. Twenty percent of the caseload used SOT and 100% of patients who were eligible opted in. Average SOT success was 79%. Total mileage savings and time saved were $9,929.07 and 614 hours. Because SOT saves cost and time and is a suitable alternative to DOT for patients, it should be considered as part of new policies and practices in TB control programs.

Implementing a computer-assisted telephone interview (CATI) system to increase colorectal cancer screening: a process evaluation.

PubMed

White, Mary Jo; Stark, Jennifer R; Luckmann, Roger; Rosal, Milagros C; Clemow, Lynn; Costanza, Mary E

2006-06-01

Computer-assisted telephone interviewing (CATI) systems used by telephone counselors (TCs) may be efficient mechanisms to counsel patients on cancer and recommended preventive screening tests in order to extend a primary care provider's reach to his/her patients. The implementation process of such a system for promoting colorectal (CRC) cancer screening using a computer-assisted telephone interview (CATI) system is reported in this paper. The process evaluation assessed three components of the intervention: message production, program implementation and audience reception. Of 1181 potentially eligible patients, 1025 (87%) patients were reached by the TCs and 725 of those patients (71%) were eligible to receive counseling. Five hundred eighty-two (80%) patients agreed to counseling. It is feasible to design and use CATI systems for prevention counseling of patients in primary care practices. CATI systems have the potential of being used as a referral service by primary care providers and health care organizations for patient education.

Managing diabetes mellitus using information technology: a systematic review.

PubMed

Riazi, H; Larijani, B; Langarizadeh, M; Shahmoradi, L

2015-01-01

To review published evidences about using information technology interventions in diabetes care and determine their effects on managing diabetes. Systematic review of information technology based interventions. MEDLINE®/PubMed were electronically searched for articles published between 2004/07/01 and 2014/07/01. A comprehensive, electronic search strategy was used to identify eligible articles. Inclusion criteria were defined based on type of study and effect of information technology based intervention in relation to glucose control and other clinical outcomes in diabetic patients. Studies must have used a controlled design to evaluate an information technology based intervention. A total of 3613 articles were identified based on the searches conducted in MEDLINE from PubMed. After excluding duplicates (n = 6), we screened titles and abstracts of 3607 articles based on inclusion criteria. The remaining articles matched with inclusion criteria (n = 277) were reviewed in full text, and 210 articles were excluded based on exclusion criteria. Finally, 67 articles complied with our eligibility criteria and were included in this study. In this study, the effect of various information technology based interventions on clinical outcomes in diabetic patients extracted and measured from selected articles is described and compared to each other. Information technology based interventions combined with the usual care are associated with improved glycemic control with different efficacy on various clinical outcomes in diabetic patients.

Subjective global assessment of nutritional status – A systematic review of the literature.

PubMed

da Silva Fink, Jaqueline; Daniel de Mello, Paula; Daniel de Mello, Elza

2015-10-01

Subjective Global Assessment (SGA) is a nutritional assessment tool widely used in hospital clinical practice, even though it is not exempted of limitations in relation to its use. This systematic review intended to update knowledge on the performance of SGA as a method for the assessment of the nutritional status of hospitalized adults. PubMed data base was consulted, using the search term "subjective global assessment". Studies published in English, Portuguese or Spanish, between 2002 and 2012 were selected, excluding those not found in full, letters to the editor, pilot studies, narrative reviews, studies with n < 30, studies with population younger than 18 years of age, research with non-hospitalized populations or those which used a modified version of the SGA. Of 454 eligible studies, 110 presented eligibility criteria. After applying the exclusion criteria, 21 studies were selected, 6 with surgical patients, 7 with clinical patients, and 8 with both. Most studies demonstrated SGA performance similar or better than the usual assessment methods for nutritional status, such as anthropometry and laboratory data, but the same result was not found when comparing SGA and nutritional screening methods. Recently published literature demonstrates SGA as a valid tool for the nutritional diagnosis of hospitalized clinical and surgical patients, and point to a potential superiority of nutritional screening methods in the early detection of malnutrition. Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Educational videos to reduce racial disparities in ICD therapy via innovative designs (VIVID): a randomized clinical trial.

PubMed

Thomas, Kevin L; Zimmer, Louise O; Dai, David; Al-Khatib, Sana M; Allen LaPointe, Nancy M; Peterson, Eric D

2013-07-01

Black individuals eligible for an implantable cardioverter/defibrillator (ICD) are considerably less likely than white individuals to receive one. This disparity may, in part, be explained by racial differences in patient preferences. We hypothesized that a targeted patient-centered educational video could improve knowledge of sudden cardiac arrest (SCA) and ICDs and reduce racial differences in ICD preferences. We conducted a pilot study to assess the feasibility of testing this hypothesis in a randomized trial. We created a video that included animation, physician commentary, and patient testimonials on SCA and ICDs. The primary outcome was the decision to have an ICD implanted as a function of race and intervention. Between January 1, 2011, and December 31, 2011, 59 patients (37 white and 22 black) were randomized to the video or health care provider counseling/usual care. Relative to white patients, black patients were younger (median age, 55 vs 68 years) and more likely to have attended college or technical school. Baseline SCA and ICD knowledge was similar and improved significantly in both racial groups after the intervention. Black patients viewing the video were as likely as white patients to want an ICD (60.0% vs 79.2%, P = .20); and among those in the usual care arm, black patients were less likely than white patients to want an ICD (42.9% vs 84.6% P = .05). Among individuals eligible for an ICD, a video decision aid increased patient knowledge and reduced racial differences in patient preference for an ICD. Copyright © 2013 Mosby, Inc. All rights reserved.

Patient-centred communication intervention study to evaluate nurse-patient interactions in complex continuing care

PubMed Central

2012-01-01

Background Communication impairment is a frequent consequence of stroke. Patients who cannot articulate their needs respond with frustration and agitation, resulting in poor optimization of post-stroke functions. A key component of patient-centred care is the ability of staff to communicate in a way that allows them to understand the patient’s needs. We developed a patient-centred communication intervention targeting registered and unregulated nursing staff caring for complex continuing care patients with communication impairments post stroke. Research objectives include 1) examining the effects of the intervention on patients’ quality of life, depression, satisfaction with care, and agitation; and (2) examining the extent to which the intervention improves staff’s attitudes and knowledge in caring for patients with communication impairments. The intervention builds on a previous pilot study. Methods/design A quasi-experimental repeated measures non-equivalent control group design in a complex continuing care facility is being used. Patients with a communication impairment post-stroke admitted to the facility are eligible to participate. All staff nurses are eligible. Baseline data are collected from staff and patients. Follow-up will occur at 1 and 3 months post-intervention. Subject recruitment and data collection from 60 patients and 30 staff will take approximately 36 months. The Patient-Centred Communication Intervention consists of three components: (1) development of an individualized patient communication care plan; (2) a one-day workshop focused on communication and behavioural management strategies for nursing staff; and (3) a staff support system. The intervention takes comprehensive patient assessments into account to inform the development of communication and behavioural strategies specifically tailored to each patient. Discussion The Patient-Centred Communication Intervention will provide staff with strategies to facilitate interactions with patients and to minimize agitation associated with considerable stress. The improvement of these interactions will lead to a reduction of agitation, which has the additional significance of increasing patients’ well-being, quality of life, and satisfaction with care. Trial registration ClinicalTrials.gov Identifier NCT01654029 PMID:23050517

Consequences of the 340B Drug Pricing Program.

PubMed

Desai, Sunita; McWilliams, J Michael

2018-02-08

The 340B Drug Pricing Program entitles qualifying hospitals to discounts on outpatient drugs, increasing the profitability of drug administration. By tying the program eligibility of hospitals to their Disproportionate Share Hospital (DSH) adjustment percentage, which reflects the proportion of hospitalized patients who are low-income, the program is intended to expand resources for underserved populations but provides no direct incentives for hospitals to use financial gains to enhance care for low-income patients. We used Medicare claims and a regression-discontinuity design, taking advantage of the threshold for program eligibility among general acute care hospitals (DSH percentage, >11.75%), to isolate the effects of the program on hospital-physician consolidation (i.e., acquisition of physician practices or employment of physicians by hospitals) and on the outpatient administration of parenteral drugs by hospital-owned facilities in three specialties in which parenteral drugs are frequently used. For low-income patients, we also assessed the effects of the program on the provision of care by hospitals and on mortality. Hospital eligibility for the 340B Program was associated with 2.3 more hematologist-oncologists practicing in facilities owned by the hospital, or 230% more hematologist-oncologists than expected in the absence of the program (P=0.02), and with 0.9 (or 900%) more ophthalmologists per hospital (P=0.08) and 0.1 (or 33%) more rheumatologists per hospital (P=0.84). Program eligibility was associated with significantly higher numbers of parenteral drug claims billed by hospitals for Medicare patients in hematology-oncology (90% higher, P=0.001) and ophthalmology (177% higher, P=0.03) but not rheumatology (77% higher, P=0.12). Program eligibility was associated with lower proportions of low-income patients in hematology-oncology and ophthalmology and with no significant differences in hospital provision of safety-net or inpatient care for low-income groups or in mortality among low-income residents of the hospitals' local service areas. The 340B Program has been associated with hospital-physician consolidation in hematology-oncology and with more hospital-based administration of parenteral drugs in hematology-oncology and ophthalmology. Financial gains for hospitals have not been associated with clear evidence of expanded care or lower mortality among low-income patients. (Funded by the Agency for Healthcare Research and Quality and others.).

Crozer-Chester Medical Center Burn Research Project

DTIC Science & Technology

2010-07-18

2010, but unfortunately needed to be cancelled by the Army. We are attempting to reschedule this visit. Study 2 (Donor Site Study): Enrollment... Nurse makes daily rounds on the burn unit to identify possible candidates for the study. Due to the limits of the eligibility criteria, enrollment...2009 – Sept 2009: Study #2 – Donor Site Study continues. The Burn Research Nurse completes daily rounds to identify patients for the donor site study

Atezolizumab in Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma: Clinical Experience from an Expanded Access Study in the United States.

PubMed

Pal, Sumanta Kumar; Hoffman-Censits, Jean; Zheng, Hanzhe; Kaiser, Constanze; Tayama, Darren; Bellmunt, Joaquim

2018-05-01

Atezolizumab (anti-programmed death-ligand 1) was approved in the USA, Europe, and elsewhere for treatment-naive and platinum-treated locally advanced/metastatic urothelial carcinoma (mUC). To report efficacy and safety from an atezolizumab expanded access study. This single-arm, open-label study enrolled 218 patients at 36 US sites. Key eligibility criteria included progression during/following ≥1 platinum-based chemotherapy for mUC or in perioperative setting (progression within 12 mo) and Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2. Patients received atezolizumab1200mg intravenously every 3 wk until loss of clinical benefit, unacceptable toxicity, consent withdrawal, decision to discontinue, death, atezolizumab commercial availability, or study closure. Key end points reported herein included Response Evaluation Criteria in Solid Tumors v1.1 objective response rate and duration, disease control rate (DCR; response or stable disease), and safety. All patients received prior systemic therapy (68% mUC; 27% adjuvant; and 26% neoadjuvant). At baseline, 57% of 214 treated patients had ECOG PS ≥1, 19% had hemoglobin <10g/dl, and 25% had liver metastases. Median treatment duration was 9 wk (interquartile range [IQR], 6-12 wk). Median follow-up duration was 2.3 mo (IQR, 1.6-3.4 mo) overall and 2.7 mo (IQR, 2.0-3.5 mo) in patients not known to have died. Seventeen of 114 evaluable patients (15%) had objective responses (16 ongoing at study termination). DCR was 49%. Treatment-related adverse events (mostly fatigue) occurred in 98 of 214 treated patients. The benefit/risk profile of atezolizumab was consistent with that observed in previous studies, despite pretreatment and poor prognostic factors. These results suggest a potential role for atezolizumab in a broader patient range than typically eligible for phase 1-3 studies. In this expanded access study, atezolizumab was active and tolerable in a range of patients with platinum-treated metastatic urothelial carcinoma. Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.

A phase 2 autologous cellular therapy trial in patients with acute, complete spinal cord injury: pragmatics, recruitment, and demographics.

PubMed

Jones, L A T; Lammertse, D P; Charlifue, S B; Kirshblum, S C; Apple, D F; Ragnarsson, K T; Poonian, D; Betz, R R; Knoller, N; Heary, R F; Choudhri, T F; Jenkins, A L; Falci, S P; Snyder, D A

2010-11-01

Post hoc analysis from a randomized controlled cellular therapy trial in acute, complete spinal cord injury (SCI). Description and quantitative review of study logistics, referral patterns, current practice patterns and subject demographics. Subjects were recruited to one of six international study centers. Data are presented from 1816 patients pre-screened, 75 participants screened and 50 randomized. Of the 1816 patients pre-screened, 53.7% did not meet initial study criteria, primarily due to an injury outside the time window (14 days) or failure to meet neurological criteria (complete SCI between C5 motor/C4 sensory and T11). MRIs were obtained on 339 patients; 51.0% were ineligible based on imaging criteria. Of the 75 participants enrolled, 25 failed screening (SF), leaving 50 randomized. The primary reason for SF was based on the neurological exam (51.9%), followed by failure to meet MRI criteria (22.2%). Of the 50 randomized subjects, there were no significant differences in demographics in the active versus control arms. In those participants for whom data was available, 93.8% (45 of 48) of randomized participants received steroids before study entry, whereas 94.0% (47 of 50) had spine surgery before study enrollment. The 'funnel effect' (large numbers of potentially eligible participants with a small number enrolled) impacts all trials, but was particularly challenging in this trial due to eligibility criteria and logistics. Data collected may provide information on current practice patterns and the issues encountered and addressed may facilitate design of future trials.

Sacubitril/valsartan and short-term changes in the 6-minute walk test: A pilot study.

PubMed

Beltrán, Paola; Palau, Patricia; Domínguez, Eloy; Faraudo, Mercedes; Núñez, Eduardo; Guri, Olga; Mollar, Anna; Sanchis, Juan; Bayés-Genís, Antoni; Núñez, Julio

2018-02-01

Impaired exercise capacity is the most disabling symptom in patients with heart failure with reduced ejection fraction (HFrEF). Despite sacubitril/valsartan showing reduced long-term morbidity and mortality over enalapril in HFrEF, its effects on short-term functional capacity remain uncertain. We sought to evaluate the effects of sacubitril/valsartan on a 30-day six-minute walk test in eligible patients with HFrEF. From November 1, 2016 to February 1, 2017, a total of 58 stable symptomatic patients with HFrEF were eligible for sacubitril/valsartan and underwent 6-MWT before and 30days after initiation of sacubitril/valsartan therapy. A mixed-effects model for repeated-measures was used to analyze the changes. Mean age was 70±11years. 72.4% males, 46.6% with ischemic heart disease, and 51.7% on NYHA functional class III were included. The mean (SD) values of baseline LVEF and 6MWT were 30±7%, and 300±89m, respectively. The median (IQR) of NT-proBNP at baseline was 2701pg/ml (1087-4200). Compared with baseline, the 6-MWT distance increased significantly at 30days by 13.9% (+∆=41.8m (33.4-50.2); p<0.001). In this pilot study, sacubitril/valsartan was associated with an improvement in exercise tolerance in symptomatic patients with HFrEF. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.