Biologic treatment eligibility for real-world patients with severe asthma: The IDEAL study.

PubMed

Albers, Frank C; Müllerová, Hana; Gunsoy, Necdet B; Shin, Ji-Yeon; Nelsen, Linda M; Bradford, Eric S; Cockle, Sarah M; Suruki, Robert Y

2018-02-01

Severe asthma comprises several distinct phenotypes. Consequently, patients with severe asthma can be eligible for more than one biologic treatment targeting Th2 inflammation, such as anti-interleukin (IL)-5 and anti-immunoglobulin (Ig) E. The objective of this study was to describe treatment eligibility and overlap in treatment eligibility for mepolizumab (anti-IL-5), omalizumab (anti-IgE) and reslizumab (anti-IL-5) in patients with severe asthma, who were recruited from clinical practice. This cross-sectional, single-visit, observational study in six countries enrolled patients with severe asthma (defined by American Thoracic Society/European Respiratory Society guidelines). Assessable patients were analysed as a total cohort and a sub-cohort, who were not currently receiving omalizumab. Treatment eligibility was defined according to the local prescribing information or protocol-defined inclusion/exclusion criteria. Patients currently receiving omalizumab were automatically categorised as omalizumab-eligible. The total cohort comprised 670 patients who met the analysis criteria, of whom 20% were eligible for mepolizumab, 31-41% were eligible for omalizumab (depending on eligibility criteria used), and 5% were eligible for reslizumab. In patients not currently receiving omalizumab (n = 502), proportions eligible for each biologic were similar (mepolizumab: 20%, reslizumab 6%) or lower (omalizumab 7-21%) than those for the total cohort. Overlap in treatment eligibility varied; in mepolizumab-eligible patients not currently receiving omalizumab (n = 101), 27-37% were omalizumab-eligible and 18% were reslizumab-eligible. Treatment eligibility for mepolizumab and omalizumab was higher than that for reslizumab. Although there was some overlap in treatment eligibility, the patient groups eligible for treatment with anti-IL-5 or anti-IgE therapies were often distinct, emphasising the different phenotypes and endotypes in severe asthma.

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

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.

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.

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.

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

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 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.

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

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

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

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

The correlation between the number of eligible patients in routine clinical practice and the low recruitment level in clinical trials: a retrospective study using electronic medical records.

PubMed

Sumi, Eriko; Teramukai, Satoshi; Yamamoto, Keiichi; Satoh, Motohiko; Yamanaka, Kenya; Yokode, Masayuki

2013-12-11

A number of clinical trials have encountered difficulties enrolling a sufficient number of patients upon initiating the trial. Recently, many screening systems that search clinical data warehouses for patients who are eligible for clinical trials have been developed. We aimed to estimate the number of eligible patients using routine electronic medical records (EMRs) and to predict the difficulty of enrolling sufficient patients prior to beginning a trial. Investigator-initiated clinical trials that were conducted at Kyoto University Hospital between July 2004 and January 2011 were included in this study. We searched the EMRs for eligible patients and calculated the eligible EMR patient index by dividing the number of eligible patients in the EMRs by the target sample size. Additionally, we divided the trial eligibility criteria into corresponding data elements in the EMRs to evaluate the completeness of mapping clinical manifestation in trial eligibility criteria into structured data elements in the EMRs. We evaluated the correlation between the index and the accrual achievement with Spearman's rank correlation coefficient. Thirteen of 19 trials did not achieve their original target sample size. Overall, 55% of the trial eligibility criteria were mapped into data elements in EMRs. The accrual achievement demonstrated a significant positive correlation with the eligible EMR patient index (r = 0.67, 95% confidence interval (CI), 0.42 to 0.92). The receiver operating characteristic analysis revealed an eligible EMR patient index cut-off value of 1.7, with a sensitivity of 69.2% and a specificity of 100.0%. Our study suggests that the eligible EMR patient index remains exploratory but could be a useful component of the feasibility study when planning a clinical trial. Establishing a step to check whether there are likely to be a sufficient number of eligible patients enables sponsors and investigators to concentrate their resources and efforts on more achievable trials.

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

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

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

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

Prospective evaluation of eligibility for thrombolytic therapy in acute myocardial infarction.

PubMed Central

French, J. K.; Williams, B. F.; Hart, H. H.; Wyatt, S.; Poole, J. E.; Ingram, C.; Ellis, C. J.; Williams, M. G.; White, H. D.

1996-01-01

OBJECTIVES--To determine the proportion of patients presenting with acute myocardial infarction who are eligible for thrombolytic therapy. DESIGN--Cohort follow up study. SETTING--The four coronary care units in Auckland, New Zealand. SUBJECTS--All 3014 patients presenting to the units with suspected myocardial infarction in 1993. MAIN OUTCOME MEASURES--Eligibility for reperfusion with thrombolytic therapy (presentation within 12 hours of the onset of ischaemic chest pain with ST elevation > or = 2 mm in leads V1-V3, ST elevation > or = 1 mm in any other two contiguous leads, or new left bundle branch block); proportions of (a) patients eligible for reperfusion and (b) patients with contraindications to thrombolysis; death (including causes); definite myocardial infarction. RESULTS--948 patients had definite myocardial infarction, 124 probable myocardial infarction, and nine ST elevation but no infarction; 1274 patients had unstable angina and 659 chest pain of other causes. Of patients with definite or probable myocardial infarction, 576 (53.3%) were eligible for reperfusion, 39 had definite contraindications to thrombolysis (risk of bleeding). Hence 49.7% of patients (537/1081) were eligible for thrombolysis and 43.5% (470) received this treatment. Hospital mortality among patients eligible for reperfusion was 11.7% (55/470 cases) among those who received thrombolysis and 17.0% (18/106) among those who did not. CONCLUSIONS--On current criteria about half of patients admitted to coronary care units with definite or probable myocardial infarction are eligible for thrombolytic therapy. Few eligible patients have definite contraindications to thrombolytic therapy. Mortality for all community admissions for myocardial infarction remains high. PMID:8664716

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.

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

Impact of Current Versus Previous Cardiac Resynchronization Therapy Guidelines on the Proportion of Patients With Heart Failure Eligible for Therapy.

PubMed

Lyons, Kristin J; Ezekowitz, Justin A; Liang, Li; Heidenreich, Paul A; Yancy, Clyde W; DeVore, Adam D; Hernandez, Adrian F; Fonarow, Gregg C

2017-05-01

This study sought to ascertain the impact of heart failure (HF) guideline change on the number of patients eligible to undergo cardiac resynchronization therapy (CRT). The 2013 HF guideline of the American College of Cardiology Foundation and American Heart Association (ACCF/AHA) narrowed the recommendations for CRT. The impact of this guideline change on the number of eligible patients for CRT has not been described. Using data from Get With The Guidelines-Heart Failure between 2012 and 2015, this study evaluated the proportion of hospitalized patients with HF who were eligible for CRT on the basis of historical and current guideline recommendations. The authors identified 25,102 hospitalizations for HF that included patients with a left ventricular ejection fraction (LVEF) ≤35% from 283 hospitals. Patients with a medical, system-related, or patient-related reason for not undergoing CRT were excluded. Overall, 49.1% (n = 12,336) of patients with HF, an LVEF ≤35%, and no documented contraindication were eligible for CRT on the basis of historical guidelines, and 33.1% (n = 8,299) of patients were eligible for CRT on the basis of current guidelines, a 16.1% absolute reduction in eligibility (p < 0.0001). Patients eligible for CRT on the basis of current guidelines were more likely to have CRT with an implantable cardioverter-defibrillator or CRT with pacing only placed or prescribed at discharge (57.8% vs. 54.9%; p < 0.0001) compared with patients eligible for CRT on the basis of historical guidelines. In this population of patients with HF, an LVEF ≤35%, and no documented contraindication for CRT, the current ACCF/AHA HF guidelines reduce the proportion of patients eligible for CRT by approximately 15%. Copyright © 2017 American College of Cardiology Foundation. 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

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

Eligibility of real-world patients with chemo-refractory, K-RAS wild-type, metastatic colorectal cancer for palliative intent regorafenib monotherapy.

PubMed

Angeles, Arkhjamil; Hung, Wayne; Cheung, Winson Y

2018-06-23

The CORRECT trial demonstrated survival benefits with regorafenib monotherapy in patients with treatment-refractory, metastatic colorectal cancer (mCRC). However, the trial's stringent eligibility criteria for regorafenib may limit its external validity. We aimed to examine treatment attrition rates and eligibility for regorafenib in routine practice. We identified patients at the British Columbia Cancer Agency diagnosed with mCRC who demonstrated disease progression or intolerable toxicity on 2 or more lines of systemic therapy. During the study timeframe, panitumumab and cetuximab were only used in the chemo-refractory setting. Data on clinicopathologic variables and patient outcomes were ascertained and analyzed. Eligibility was determined using the CORRECT trial criteria. A total of 391 patients were identified, among whom only 39% were eligible for regorafenib: 35% in the panitumumab group and 51% in the cetuximab group. The main reasons for ineligibility in all patients were Eastern Cooperative Oncology Group Performance Status (ECOG PS) > 1 (69%), an elevated total bilirubin (21%), and thromboembolic events in the past 6 months (10%). No difference in eligibility for regorafenib was observed between patients previously receiving panitumumab or cetuximab (P = 0.914; 95% CI 0.550-1.951). Kaplan-Meier analyses showed that regorafenib-eligible compared to regorafenib-ineligible patients had an increased median overall survival of 5.3 versus 2.1 months, respectively (P < 0.001). However, Cox proportional hazard analyses showed that only ECOG PS rather than trial eligibility was correlated with outcomes. The strict eligibility criteria disqualify most patients with treatment-refractory mCRC for regorafenib therapy. Future trials should broaden the eligibility criteria to improve external validity.

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.

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.

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

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.

The generalizability of bronchiectasis randomized controlled trials: A multicentre cohort study.

PubMed

Chalmers, James D; McDonnell, Melissa J; Rutherford, Robert; Davidson, John; Finch, Simon; Crichton, Megan; Dupont, Lieven; Hill, Adam T; Fardon, Thomas C; De Soyza, Anthony; Aliberti, Stefano; Goeminne, Pieter

2016-03-01

Randomized controlled trials (RCTs) for bronchiectasis have experienced difficulties with recruitment and in reaching their efficacy end-points. To estimate the generalizability of such studies we applied the eligibility criteria for major RCTs in bronchiectasis to 6 representative observational European Bronchiectasis cohorts. Inclusion and exclusion criteria from 10 major RCTs were applied in each cohort. Demographics and outcomes were compared between patients eligible and ineligible for RCTs. 1672 patients were included. On average 33.0% were eligible for macrolide trials, 15.0% were eligible for inhaled antibiotic trials, 15.9% for the DNAse study and 47.7% were eligible for a study of dry powder mannitol. Within these groups, some trials were highly selective with only 1-9% of patients eligible. Eligible patients were generally more severe with higher mortality during follow-up (mean 17.2 vs 9.0% for macrolide studies, 19.2%% vs 10.7% for inhaled antibiotic studies), and a higher frequency of exacerbations than ineligible patients. As up to 93% of patients were ineligible for studies, however, numerically more deaths and exacerbations occurred in ineligible patient across studies (mean 56% of deaths occurred in ineligible patients across all studies). Our data suggest that patients enrolled in RCT's in bronchiectasis are only partially representative of patients in clinical practice. The majority of mortality and morbidity in bronchiectasis occurs in patients ineligible for many current trials. Copyright © 2016 Elsevier Ltd. All rights reserved.

A prospective analysis of the influence of older age on physician and patient decision-making when considering enrollment in breast cancer clinical trials (SWOG S0316).

PubMed

Javid, Sara H; Unger, Joseph M; Gralow, Julie R; Moinpour, Carol M; Wozniak, Antoinette J; Goodwin, J Wendall; Lara, Primo N; Williams, Pamela A; Hutchins, Laura F; Gotay, Carolyn C; Albain, Kathy S

2012-01-01

Patients older than 65 years are underrepresented in clinical trials. We conducted a prospective study (SWOG S0316) to determine physician- and patient-perceived barriers to breast cancer clinical trial enrollment for older patients. Eight geographically diverse SWOG institutions participated. The study assessed patients' and physicians' decisions to enroll in or decline clinical treatment trials, including demographics, trial availability, and eligibility. Patient and physician questionnaires elicited concerns related to treatment, medical status, age, family, and financial or transportation concerns. A total of 1,079 patients were registered and eligible and 909 (84%) returned for follow-up. The major reason for nonaccrual was either trial unavailability or ineligibility (60%). Older patients were less likely to be eligible for trials (65% for age ≥65 years vs. 78% for age <65 years). If eligible, trial participation rates did not differ significantly by age (34% for age ≥65 years vs. 40% for age <65 years). Patients ≥65 years more often were concerned about side effects, had friends opposed to participation, or believed that participation would not benefit other generations. When trials were available and patients were eligible, physicians discussed trial participation with 76% of patients <65 years versus 58% of patients ≥65 years of age. For patients ≥65 years, 11% of physicians indicated age as a reason they did not enroll a patient in a clinical trial. Trial unavailability or patient ineligibility were the major reasons for lack of enrollment in breast cancer clinical trials for patients of all ages in this prospective study. Older patients were less likely to be eligible for trials, but if eligible they participated at similar rates to younger patients.

Videolaparoscopic Catheter Placement Reduces Contraindications to Peritoneal Dialysis

PubMed Central

Santarelli, Stefano; Zeiler, Matthias; Monteburini, Tania; Agostinelli, Rosa Maria; Marinelli, Rita; Degano, Giorgio; Ceraudo, Emilio

2013-01-01

♦ Background: Videolaparoscopy is considered the reference method for peritoneal catheter placement in patients with previous abdominal surgery. The placement procedure is usually performed with at least two access sites: one for the catheter and the second for the laparoscope. Here, we describe a new one-port laparoscopic procedure that uses only one abdominal access site in patients not eligible for laparotomic catheter placement. ♦ Method: We carried out one-port laparoscopic placement in 21 patients presenting contraindications to blind surgical procedures because of prior abdominal surgery. This technique consists in the creation of a single mini-laparotomy access through which laparoscopic procedures and placement are performed. The catheter, rectified by an introducer, is inserted inside the port. Subsequently, the port is removed, leaving the catheter in pelvic position. The port is reintroduced laterally to the catheter, confirming or correcting its position. Laparotomic placement was performed in a contemporary group of 32 patients without contraindications to blind placement. Complications and long-term catheter outcome in the two groups were evaluated. ♦ Results: Additional interventions during placement were necessary in 12 patients of the laparoscopy group compared with 5 patients of the laparotomy group (p = 0.002). Laparoscopy documented adhesions in 13 patients, with need for adhesiolysis in 6 patients. Each group had 1 intraoperative complication: leakage in the laparoscopy group, and intestinal perforation in the laparotomy group. During the 2-year follow-up period, laparoscopic revisions had to be performed in 6 patients of the laparoscopy group and in 5 patients of the laparotomy group (p = 0.26). The 1-year catheter survival was similar in both groups. Laparoscopy increased by 40% the number of patients eligible to receive peritoneal dialysis. ♦ Conclusions: Videolaparoscopy placement in patients not eligible for blind surgical procedures seems to be equivalent to laparotomic placement with regard to complications and long-term catheter outcome. The number of patients able to receive peritoneal dialysis is substantially increased. PMID:23209040

Assessment of the External Validity of the National Comprehensive Cancer Network and European Society for Medical Oncology Guidelines for Non-Small-Cell Lung Cancer in a Population of Patients Aged 80 Years and Older.

PubMed

Battisti, Nicolò Matteo Luca; Sehovic, Marina; Extermann, Martine

2017-09-01

Non-small-cell lung cancer (NSCLC) is a disease of the elderly, who are under-represented in clinical trials. This challenges the external validity of the evidence base for its management and of current guidelines, that we evaluated in a population of older patients. We retrieved randomized clinical trials (RCTs) supporting the guidelines and identified 18 relevant topics. We matched a cohort of NSCLC patients aged older than 80 years from the Moffitt Cancer Center database with the studies' eligibility criteria to check their qualification for at least 2 studies. Eligibility > 60% was rated full validity, 30% to 60% partial validity, and < 30% limited validity. We obtained data from 760 elderly patients in stage-adjusted groups and collected 244 RCTs from the National Comprehensive Cancer Network (NCCN) and 148 from the European Society for Medical Oncology (ESMO) guidelines. External validity was deemed insufficient for neoadjuvant chemotherapy in stage III disease (27.37% and 25.26% of patients eligible for NCCN and ESMO guidelines, respectively) and use of bevacizumab (13.86% and 16.27% of patients eligible). For ESMO guidelines, it was inadequate regarding double-agent chemotherapy (25.90% of patients eligible), its duration (24.10%) and therapy for Eastern Cooperative Oncology Group performance status 2 patients (17.74%). For NCCN guidelines external validity was lacking for neoadjuvant chemoradiotherapy in stage IIIA disease (25.86% of patients eligible). Our analysis highlighted the effect of RCT eligibility criteria on guidelines' external validity in elderly patients. Eligibility criteria should be carefully considered in trial design and more studies that do not exclude elderly patients should be included in guidelines. Copyright © 2017 Elsevier Inc. All rights reserved.

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 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.

Immediate chest X-ray for patients at risk of lung cancer presenting in primary care: randomised controlled feasibility trial

PubMed Central

Neal, Richard D; Barham, Allan; Bongard, Emily; Edwards, Rhiannon Tudor; Fitzgibbon, Jim; Griffiths, Gareth; Hamilton, Willie; Hood, Kerenza; Nelson, Annmarie; Parker, David; Porter, Cath; Prout, Hayley; Roberts, Kirsty; Rogers, Trevor; Thomas-Jones, Emma; Tod, Angela; Yeo, Seow Tien; Hurt, Chris N

2017-01-01

Background: Achieving earlier stage diagnosis is one option for improving lung cancer outcomes in the United Kingdom. Patients with lung cancer typically present with symptoms to general practitioners several times before referral or investigation. Methods: We undertook a mixed methods feasibility individually randomised controlled trial (the ELCID trial) to assess the feasibility and inform the design of a definitive, fully powered, UK-wide, Phase III trial of lowering the threshold for urgent investigation of suspected lung cancer. Patients over 60, with a smoking history, presenting with new chest symptoms to primary care, were eligible to be randomised to intervention (urgent chest X-ray) or usual care. Results: The trial design and materials were acceptable to GPs and patients. We randomised 255 patients from 22 practices, although the proportion of eligible patients who participated was lower than expected. Survey responses (89%), and the fidelity of the intervention (82% patients X-rayed within 3 weeks) were good. There was slightly higher anxiety and depression in the control arm in participants aged >75. Three patients (1.2%) were diagnosed with lung cancer. Conclusions: We have demonstrated the feasibility of individually randomising patients at higher risk of lung cancer, to a trial offering urgent investigation or usual care. PMID:28072761

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

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.

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

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

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.

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.

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

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

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.

Speed of Adoption of Immune Checkpoint Inhibitors of Programmed Cell Death 1 Protein and Comparison of Patient Ages in Clinical Practice vs Pivotal Clinical Trials.

PubMed

O'Connor, Jeremy M; Fessele, Kristen L; Steiner, Jean; Seidl-Rathkopf, Kathi; Carson, Kenneth R; Nussbaum, Nathan C; Yin, Emily S; Adelson, Kerin B; Presley, Carolyn J; Chiang, Anne C; Ross, Joseph S; Abernethy, Amy P; Gross, Cary P

2018-05-10

The US Food and Drug Administration (FDA) is increasing its pace of approvals for novel cancer therapeutics, including for immune checkpoint inhibitors of programmed cell death 1 protein (anti-PD-1 agents). However, little is known about how quickly anti-PD-1 agents reach eligible patients in practice or whether such patients differ from those studied in clinical trials that lead to FDA approval (pivotal clinical trials). To assess the speed with which anti-PD-1 agents reached eligible patients in practice and to compare the ages of patients treated in clinical practice with the ages of those treated in pivotal clinical trials. This retrospective cohort study, performed from January 1, 2011, through August 31, 2016, included patients from the Flatiron Health Network who were eligible for anti-PD-1 treatment of selected cancer types, which included melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC). Cumulative proportions of eligible patients receiving anti-PD-1 treatment and their age distributions. The study identified 3089 patients who were eligible for anti-PD-1 treatment (median age, 66 [interquartile range, 56-75] years for patients with melanoma, 66 [interquartile range, 58-72] years for patients with RCC, and 67 [interquartile range, 59-74] years for patients with NSCLC; 1742 male [56.4%] and 1347 [43.6%] female; 2066 [66.9%] white). Of these patients, 2123 (68.7%) received anti-PD-1 treatment, including 439 eligible patients with melanoma (79.1%), 1417 eligible patients with NSCLC (65.6%), and 267 eligible patients with RCC (71.2%). Within 4 months after FDA approval, greater than 60% of eligible patients in each cohort had received anti-PD-1 treatment. Overall, similar proportions of older and younger patients received anti-PD-1 treatment during the first 9 months after FDA approval. However, there were significant differences in age between clinical trial participants and patients receiving anti-PD-1 treatment in clinical practice, with more patients being older than 65 years in clinical practice (range, 327 of 1365 [60.6%] to 46 of 72 [63.9%]) than in pivotal clinical trials (range, 38 of 120 [31.7%] to 223 of 544 [41.0%]; all P < .001). Anti-PD-1 agents rapidly reached patients in clinical practice, and patients treated in clinical practice differed significantly from patients treated in pivotal clinical trials. Future actions are needed to ensure that rapid adoption occurs on the basis of representative trial evidence.

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

Non-entry of eligible patients into the Australasian Laparoscopic Colon Cancer Study.

PubMed

Abraham, Ned S; Hewett, Peter; Young, Jane M; Solomon, Michael J

2006-09-01

There is currently a need to assess the reasons for non-entry of eligible patients into surgical randomized controlled trials to determine measures to improve the low recruitment rates in such trials. Reasons for non-entry of all eligible patients not recruited into the Australasian Laparoscopic Colon Cancer Study were prospectively recorded using a survey completed by the participating surgeons for a period of 6 months. In the 6-month period of the study, 51 (45%) out of 113 eligible patients examined by the 18 actively participating surgeons were recruited into the trial. Eighty-nine reasons were recorded for the non-entry of the 62 eligible patients. The most commonly recorded reason was preference for one form of surgery (42%) or the surgeon (31%) by the patient (45 patients (73%) in total). This was followed by lack of time (10 patients (16%)), hospital accreditation (7 patients (11%)) or staffing/equipment (6 patients (10%)). Concern about the doctor-patient relationship or causing the patient anxiety was recorded for three (5%) and two (3%) patients, respectively. Recruitment was positively associated with the availability of a data manager (chi2 = 19.91; P < 0.001, odds ratio (95% confidence interval) = 9.50 (3.53-25.53)) and negatively associated with an increased caseload (more than five eligible patients seen by the surgeon in the study period) (continuity adjusted chi2 = 16.052; P < 0.001, odds ratio (95% confidence interval) = 0.11(0.04-0.30)). Having a preference for one form of surgery by the patient or the surgeon was the most common reason for non-entry of eligible patients in the Australasian Laparoscopic Colon Cancer Study. Concern about the doctor-patient relationship played a minimal role in determining the outcome of recruitment. Patient and surgeon preferences, caseload and the distribution of supportive staff such as data managers according to patient population density should be considered in the planning of future trials.

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.

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

Multidisciplinary ALS Telemedicine Care: The Store and Forward Method.

PubMed

Pulley, Michael T; Brittain, Rebecca; Hodges, Wayne; Frazier, Christine; Miller, Leslie; Matyjasik-Liggett, Maria; Maurer, Susan; Peters, Melissa; Solomon, Kimberly; Berger, Alan R

2018-05-26

ALS patients benefit from multidisciplinary care in an ALS clinic. We studied whether multidisciplinary care of ALS patients using the store and forward method of telemedicine was feasible and acceptable to patients and providers. ALS patients seen in the UF Jacksonville ALS clinic were eligible. A trained telemedicine nurse performed and recorded a multidisciplinary assessment of the patient in their home. Clinic team members reviewed the assessments, provided recommendations and the clinic director discussed the plan with the patient via videoconference. Patient and provider satisfaction was evaluated using surveys. 18 patients completed a total of 27 telemedicine visits. Patient satisfaction was excellent and provider satisfaction was very good. The store and forward method of telemedicine is an acceptable alternative to live telemedicine for the multidisciplinary care of ALS patients. This method of care may improve access to multidisciplinary care for this patient population. This article is protected by copyright. All rights reserved. © 2018 Wiley Periodicals, Inc.

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

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.

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

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

Four layer bandage compared with short stretch bandage for venous leg ulcers: systematic review and meta-analysis of randomised controlled trials with data from individual patients

PubMed Central

Tierney, Jayne; Cullum, Nicky; Bland, J Martin; Franks, Peter J; Mole, Trevor; Scriven, Mark

2009-01-01

Objective To compare the effectiveness of two types of compression treatment (four layer bandage and short stretch bandage) in people with venous leg ulceration. Design Systematic review and meta-analysis of patient level data. Data sources Electronic databases (the Cochrane Central Register of Controlled Trials, the Cochrane Wounds Group Specialised Register, Medline, Embase, CINAHL, and National Research Register) and reference lists of retrieved articles searched to identify relevant trials and primary investigators. Primary investigators of eligible trials were invited to contribute raw data for re-analysis. Review methods Randomised controlled trials of four layer bandage compared with short stretch bandage in people with venous leg ulceration were eligible for inclusion. The primary outcome for the meta-analysis was time to healing. Cox proportional hazards models were run to compare the methods in terms of time to healing with adjustment for independent predictors of healing. Secondary outcomes included incidence and number of adverse events per patient. Results Seven eligible trials were identified (887 patients), and patient level data were retrieved for five (797 patients, 90% of known randomised patients). The four layer bandage was associated with significantly shorter time to healing: hazard ratio (95% confidence interval) from multifactorial model based on five trials was 1.31 (1.09 to 1.58), P=0.005. Larger ulcer area at baseline, more chronic ulceration, and previous ulceration were all independent predictors of delayed healing. Data from two trials showed no evidence of a difference in adverse event profiles between the two bandage types. Conclusions Venous leg ulcers in patients treated with four layer bandages heal faster, on average, than those of people treated with the short stretch bandage. Benefits were consistent across patients with differing prognostic profiles. PMID:19376798

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.

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

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

Optimizing stroke clinical trial design: estimating the proportion of eligible patients.

PubMed

Taylor, Alexis; Castle, Amanda; Merino, José G; Hsia, Amie; Kidwell, Chelsea S; Warach, Steven

2010-10-01

Clinical trial planning and site selection require an accurate estimate of the number of eligible patients at each site. In this study, we developed a tool to calculate the proportion of patients who would meet a specific trial's age, baseline severity, and time to treatment inclusion criteria. From a sample of 1322 consecutive patients with acute ischemic cerebrovascular syndromes, we developed regression curves relating the proportion of patients within each range of the 3 variables. We used half the patients to develop the model and the other half to validate it by comparing predicted vs actual proportions who met the criteria for 4 current stroke trials. The predicted proportion of patients meeting inclusion criteria ranged from 6% to 28% among the different trials. The proportion of trial-eligible patients predicted from the first half of the data were within 0.4% to 1.4% of the actual proportion of eligible patients. This proportion increased logarithmically with National Institutes of Health Stroke Scale score and time from onset; lowering the baseline limits of the National Institutes of Health Stroke Scale score and extending the treatment window would have the greatest impact on the proportion of patients eligible for a stroke trial. This model helps estimate the proportion of stroke patients eligible for a study based on different upper and lower limits for age, stroke severity, and time to treatment, and it may be a useful tool in clinical trial planning.

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…

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.

International Myeloma Working Group Consensus Statement for the Management, Treatment, and Supportive Care of Patients With Myeloma Not Eligible for Standard Autologous Stem-Cell Transplantation

PubMed Central

Palumbo, Antonio; Rajkumar, S. Vincent; San Miguel, Jesus F.; Larocca, Alessandra; Niesvizky, Ruben; Morgan, Gareth; Landgren, Ola; Hajek, Roman; Einsele, Hermann; Anderson, Kenneth C.; Dimopoulos, Meletios A.; Richardson, Paul G.; Cavo, Michele; Spencer, Andrew; Stewart, A. Keith; Shimizu, Kazuyuki; Lonial, Sagar; Sonneveld, Pieter; Durie, Brian G.M.; Moreau, Philippe; Orlowski, Robert Z.

2014-01-01

Purpose To provide an update on recent advances in the management of patients with multiple myeloma who are not eligible for autologous stem-cell transplantation. Methods A comprehensive review of the literature on diagnostic criteria is provided, and treatment options and management of adverse events are summarized. Results Patients with symptomatic disease and organ damage (ie, hypercalcemia, renal failure, anemia, or bone lesions) require immediate treatment. The International Staging System and chromosomal abnormalities identify high- and standard-risk patients. Proteasome inhibitors, immunomodulatory drugs, corticosteroids, and alkylating agents are the most active agents. The presence of concomitant diseases, frailty, or disability should be assessed and, if present, treated with reduced-dose approaches. Bone disease, renal damage, hematologic toxicities, infections, thromboembolism, and peripheral neuropathy are the most frequent disabling events requiring prompt and active supportive care. Conclusion These recommendations will help clinicians ensure the most appropriate care for patients with myeloma in everyday clinical practice. PMID:24419113

Considerations on bringing warehoused HCV patients into active care following interferon-free, direct-acting antiviral drug approval.

PubMed

Palak, Aleksandra; Livoti, Christine; Audibert, Céline

2017-05-01

Until recently, lack of efficacious and tolerable hepatitis C virus (HCV) treatments prompted patient warehousing until better treatment options became available. We investigated whether the introduction of ledipasvir/sofosbuvir precipitated patient return to clinics, thereby changing HCV clinic dynamics. Online questionnaire responses indicated the volume of HCV patients followed, the proportion of warehoused patients and those who were proactively offered new options, methods for identifying and contacting patients, and insurance authorization/reimbursement-related information. Of 168 practices surveyed, 19% indicated no patient warehousing in the previous 3 years; 81% had warehoused 40% of patients; 92% were able to handle their patient load; and 82% had not changed practices to accommodate more HCV patients in the previous 12 months. Of the 35% of patients who were ledipasvir/sofosbuvir-eligible, 50% already completed/are completing therapy, 21% were not treated due to insurance denial, and 19% were awaiting responses from insurance companies. Launch of a new treatment did not overburden HCV practices. Patients eligible to receive new treatments were being treated, but pre-authorization processes and reimbursement denials reduced the numbers of treated patients.

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

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

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.

Evaluating biomarkers for prognostic enrichment of clinical trials.

PubMed

Kerr, Kathleen F; Roth, Jeremy; Zhu, Kehao; Thiessen-Philbrook, Heather; Meisner, Allison; Wilson, Francis Perry; Coca, Steven; Parikh, Chirag R

2017-12-01

A potential use of biomarkers is to assist in prognostic enrichment of clinical trials, where only patients at relatively higher risk for an outcome of interest are eligible for the trial. We investigated methods for evaluating biomarkers for prognostic enrichment. We identified five key considerations when considering a biomarker and a screening threshold for prognostic enrichment: (1) clinical trial sample size, (2) calendar time to enroll the trial, (3) total patient screening costs and the total per-patient trial costs, (4) generalizability of trial results, and (5) ethical evaluation of trial eligibility criteria. Items (1)-(3) are amenable to quantitative analysis. We developed the Biomarker Prognostic Enrichment Tool for evaluating biomarkers for prognostic enrichment at varying levels of screening stringency. We demonstrate that both modestly prognostic and strongly prognostic biomarkers can improve trial metrics using Biomarker Prognostic Enrichment Tool. Biomarker Prognostic Enrichment Tool is available as a webtool at http://prognosticenrichment.com and as a package for the R statistical computing platform. In some clinical settings, even biomarkers with modest prognostic performance can be useful for prognostic enrichment. In addition to the quantitative analysis provided by Biomarker Prognostic Enrichment Tool, investigators must consider the generalizability of trial results and evaluate the ethics of trial eligibility criteria.

Eligibility of real-life patients with COPD for inclusion in trials of inhaled long-acting bronchodilator therapy.

PubMed

Halpin, David M G; Kerkhof, Marjan; Soriano, Joan B; Mikkelsen, Helga; Price, David B

2016-09-23

Management guidelines of chronic obstructive pulmonary disease (COPD) are mainly based on results of randomised controlled trials (RCTs), but some authors have suggested limited representativeness of patients included in these trials. No previous studies have applied the full range of selection criteria to a broad COPD patient population in a real-life setting. We identified all RCTs of inhaled long-acting bronchodilator therapy, during 1999-2013, at ClinicalTrials.gov and translated trial selection criteria into definitions compatible with electronic medical records. Eligibility was calculated for each RCT by applying these criteria to a uniquely representative, well-characterised population of patients with COPD from the Optimum Patient Care Research Database (OPCRD). Median eligibility of 36 893 patients with COPD for participation in 31 RCTs was 23 % (interquartile range 12-38). Two studies of olodaterol showed the highest eligibility of 55 and 58 %. Conversely, the lowest eligibility was observed in two studies that required a history of exacerbations in the past year (3.5 and 3.9 %). For the patient subgroup with modified Medical Research Council score ≥2, the overall median eligibility was 27 %. By applying an extensive range of RCT selection criteria to a large, representative COPD patient population, this study highlights that the interpretation of results from RCTs must take into account that RCT participants are variably, but generally more representative of patients in the community than previously believed.

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

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

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

Balloon or bougie for dilatation of benign oesophageal stricture? An interim report of a randomised controlled trial.

PubMed Central

Cox, J G; Winter, R K; Maslin, S C; Jones, R; Buckton, G K; Hoare, R C; Sutton, D R; Bennett, J R

1988-01-01

Seventy one patients with benign oesophageal strictures were randomised to receive balloon or bougie dilatation. Sixty five patients were eligible for analysis. At the end of five months the balloon group had significantly more dysphagia and the calibre of the strictures in the balloon group had narrowed by a greater degree. The methods were equally safe and acceptable to patients. While the choice of the method of dilatation depends on the individual patient's needs and operator experience, bougie dilatation is more effective in reducing dysphagia and maintaining stricture patency. Images Fig. 2 Fig. 3 PMID:3065156

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

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.

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.

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.

75 FR 57277 - Agency Information Collection Activities: Proposed Collection: Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-20

... patients served, pharmaceuticals prescribed, pricing, and other sources of support to provide AIDS... formulary, eligibility criteria for enrollment, and cost-saving strategies including coordinating with Medicaid). The quarterly report represents the best method for HRSA to determine how ADAP grants are being...

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.

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.

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

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

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.

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

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.

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

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.

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.

Determining the Number of Ischemic Strokes Potentially Eligible for Endovascular Thrombectomy: A Population-Based Study.

PubMed

Chia, Nicholas H; Leyden, James M; Newbury, Jonathan; Jannes, Jim; Kleinig, Timothy J

2016-05-01

Endovascular thrombectomy (ET) is standard-of-care for ischemic stroke patients with large vessel occlusion, but estimates of potentially eligible patients from population-based studies have not been published. Such data are urgently needed to rationally plan hyperacute services. Retrospective analysis determined the incidence of ET-eligible ischemic strokes in a comprehensive population-based stroke study (Adelaide, Australia 2009-2010). Stroke patients were stratified via a prespecified eligibility algorithm derived from recent ET trials comprising stroke subtype, pathogenesis, severity, premorbid modified Rankin Score, presentation delay, large vessel occlusion, and target mismatch penumbra. Recognizing centers may interpret recent ET trials either loosely or rigidly; 2 eligibility algorithms were applied: restrictive (key criteria modified Rankin Scale score 0-1, presentation delay <3.5 hours, and target mismatch penumbra) and permissive (modified Rankin Scale score 0-3 and presentation delay <5 hours). In a population of 148 027 people, 318 strokes occurred in the 1-year study period (crude attack rate 215 [192-240] per 100 000 person-years). The number of ischemic strokes eligible by restrictive criteria was 17/258 (7%; 95% confidence intervals 4%-10%) and by permissive criteria, an additional 16 were identified, total 33/258 (13%; 95% confidence intervals 9%-18%). Two of 17 patients (and 6/33 permissive patients) had thrombolysis contraindications. Using the restrictive algorithm, there were 11 (95% confidence intervals 4-18) potential ET cases per 100 000 person-years or 22 (95% confidence intervals 13-31) using the permissive algorithm. In this cohort, ≈7% of ischemic strokes were potentially eligible for ET (13% with permissive criteria). In similar populations, the permissive criteria predict that ≤22 strokes per 100 000 person-years may be eligible for ET. © 2016 American Heart Association, Inc.

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.

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

Local Excision Alone Without Irradiation for Ductal Carcinoma In Situ of the Breast: A Trial of the Eastern Cooperative Oncology Group

PubMed Central

Hughes, Lorie L.; Wang, Molin; Page, David L.; Gray, Robert; Solin, Lawrence J.; Davidson, Nancy E.; Lowen, Mary Ann; Ingle, James N.; Recht, Abram; Wood, William C.

2009-01-01

Purpose To determine the risk of ipsilateral breast events in patients with ductal carcinoma in situ (DCIS) treated with local excision without irradiation. Patients and Methods Patients with either low- or intermediate-grade DCIS measuring 2.5 cm or smaller, or high-grade DCIS measuring 1 cm or smaller who had microscopic margin widths of 3 mm or wider and no residual calcifications on postoperative mammograms were eligible for a prospective trial conducted from 1997 to 2002 by the Eastern Cooperative Oncology Group and North Central Cancer Treatment Group. Patients entered in 2000 and later could take tamoxifen if they wished. Median age at last surgery for the entire population was 60 years (range, 28 to 88 years), and median tumor sizes in the two strata were 6 mm and 5 mm, respectively. Results With a median follow-up of 6.2 years, the 5-year rate of ipsilateral breast events in the 565 eligible patients in the low/intermediate grade stratum was 6.1% (95% CI, 4.1% to 8.2%). With a median follow-up of 6.7 years, this incidence for the 105 eligible patients in the high-grade stratum was 15.3% (95% CI, 8.2% to 22.5%). Conclusion Rigorously evaluated and selected patients with low- to intermediate-grade DCIS with margins 3 mm or wider had an acceptably low rate of ipsilateral breast events at 5 years after excision without irradiation. Patients with high-grade lesions had a much higher rate, suggesting that excision alone is inadequate treatment. Further follow-up is necessary to document long-term results. PMID:19826126

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

Automated clinical trial eligibility prescreening: increasing the efficiency of patient identification for clinical trials in the emergency department

PubMed Central

Ni, Yizhao; Kennebeck, Stephanie; Dexheimer, Judith W; McAneney, Constance M; Tang, Huaxiu; Lingren, Todd; Li, Qi; Zhai, Haijun; Solti, Imre

2015-01-01

Objectives (1) To develop an automated eligibility screening (ES) approach for clinical trials in an urban tertiary care pediatric emergency department (ED); (2) to assess the effectiveness of natural language processing (NLP), information extraction (IE), and machine learning (ML) techniques on real-world clinical data and trials. Data and methods We collected eligibility criteria for 13 randomly selected, disease-specific clinical trials actively enrolling patients between January 1, 2010 and August 31, 2012. In parallel, we retrospectively selected data fields including demographics, laboratory data, and clinical notes from the electronic health record (EHR) to represent profiles of all 202795 patients visiting the ED during the same period. Leveraging NLP, IE, and ML technologies, the automated ES algorithms identified patients whose profiles matched the trial criteria to reduce the pool of candidates for staff screening. The performance was validated on both a physician-generated gold standard of trial–patient matches and a reference standard of historical trial–patient enrollment decisions, where workload, mean average precision (MAP), and recall were assessed. Results Compared with the case without automation, the workload with automated ES was reduced by 92% on the gold standard set, with a MAP of 62.9%. The automated ES achieved a 450% increase in trial screening efficiency. The findings on the gold standard set were confirmed by large-scale evaluation on the reference set of trial–patient matches. Discussion and conclusion By exploiting the text of trial criteria and the content of EHRs, we demonstrated that NLP-, IE-, and ML-based automated ES could successfully identify patients for clinical trials. PMID:25030032

Recruiting Ethnically Diverse General Internal Medicine Patients for a Telephone Survey on Physician-Patient Communication

PubMed Central

Nápoles-Springer, Anna M; Santoyo, Jasmine; Stewart, Anita L

2005-01-01

BACKGROUND Limited evidence exists on the effectiveness of recruitment methods among diverse populations. OBKECTIVE Describe response rates by recruitment stage, ethnic-language group, and type of initial contact letter (for African-American and Latino patients). DESIGN Tracking of response status by recruitment stage and ethnic-language group and a randomized trial of ethnically tailored initial letters nested within a cross-sectional telephone survey on physician-patient communication. PARTICIPANTS Adult general medicine patients with ≥1 visit during the preceding year, stratified by 4 categories: African-American (N= 1,400), English-speaking Latino (N= 894), Spanish-speaking Latino (N= 965), and non-Latino white (N= 1,400). MEASUREMENTS AND RESULTS Ethnically tailored initial letters referred to shortages of African-American (or Latino) physicians and the need to learn about the experiences of African-American (or Latino) patients communicating with physicians. Of 2,482 patients contacted, eligible, and able to participate (identified eligibles), 69.9% completed the survey. Thirty-nine percent of the sampling frame was unable to be contacted, with losses higher among non-Latino whites (46.5%) and African Americans (44.2%) than among English-speaking (32.3%) and Spanish-speaking Latinos (25.1%). For identified eligibles, response rates were highest among Spanish-speaking Latinos (75.2%), lowest for non-Latino whites (66.4%), and intermediate for African Americans (69.7%) and English-speaking Latinos (68.1%). There were no differences in overall response rates between patients receiving ethnically tailored letters (72.2%) and those receiving general letters (70.0%). CONCLUSIONS Household contact and individual response rates differed by ethnic-language group, highlighting the importance of tracking losses by stage and subpopulation. Careful attention to recruitment yielded acceptable response rates among all groups. PMID:15963168

Evaluation of a Public-sector, Provider-initiated Cryptococcal Antigen Screening and Treatment Program, Western Cape, South Africa

PubMed Central

Smith, Mariette; Smith, Rachel; Osler, Meg; Kelly, Nicola; Cross, Anna; Boulle, Andrew; Meintjes, Graeme; Govender, Nelesh P.

2016-01-01

Background Screening for serum cryptococcal antigen (CrAg) may identify those at risk for disseminated cryptococcal disease (DCD), and pre-emptive fluconazole treatment may prevent progression to DCD. In August 2012, the Western Cape Province (WC), South Africa, adopted provider-initiated CrAg screening. We evaluated the implementation and effectiveness of this large-scale public-sector program during its first year, September 1, 2012—August 31, 2013. Methods We used data from the South African National Health Laboratory Service, WC provincial HIV program, and nationwide surveillance data for DCD. We assessed the proportion of eligible patients screened for CrAg (CrAg test done within 30 days of CD4 date) and the prevalence of CrAg positivity. Incidence of DCD among those screened was compared with those not screened. Results Of 4,395 eligible patients, 26.6% (n=1170) were screened. The proportion of patients screened increased from 15.9% in September 2012 to 36.6% in August 2013. The prevalence of positive serum CrAg was 2.1%. Treatment data were available for 13 of 24 CrAg-positive patients; nine of 13 were treated with fluconazole. Nine (0.8%) incident cases of DCD occurred among the 1170 patients who were screened for CrAg vs. 49 (1.5%) incident cases among the 3225 patients not screened (p=0.07). Conclusions Relatively few eligible patients were screened under the WC provider-initiated CrAg screening program. Unscreened patients were nearly twice as likely to develop DCD. CrAg screening can reduce the burden of DCD, but needs to be implemented well. To improve screening rates, countries should consider laboratory-based reflexive screening when possible. PMID:26926942

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

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

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.

Justice Can Further Improve Its Monitoring of Changes in State/Local Voting Laws.

DTIC Science & Technology

1983-12-19

voter quali- fications and eligibility; registration, bal- loting and vote counting procedures; and the eligibility or method of selecting candidates...voter qualifications and eligibility; registration, balloting, and vote counting procedures; and the eligibility or method of *$ selecting candidates...reapportionments, -* annexations, method -of-election, and bilingual assistance to mi- nority language groups. Forty-nine of the withdrawals occurred after the

A Randomized Clinical Trial Comparing Use of Rapid Molecular Testing for Staphylococcus aureus for Patients With Cutaneous Abscesses in the Emergency Department With Standard of Care

PubMed Central

May, Larissa S.; Rothman, Richard E.; Miller, Loren G.; Brooks, Gillian; Zocchi, Mark; Zatorski, Catherine; Dugas, Andrea F.; Ware, Chelsea E.; Jordan, Jeanne A.

2017-01-01

OBJECTIVE To determine whether real-time availability of rapid molecular results of Staphylococcus aureus would impact emergency department clinician antimicrobial selection for adults with cutaneous abscesses. DESIGN We performed a prospective, randomized controlled trial comparing a rapid molecular test with standard of care culture-based testing. Follow-up telephone calls were made at between 2 and 7 days, 1 month, and 3 months after discharge. SETTING Two urban, academic emergency departments. PATIENTS Patients at least 18 years old presenting with a chief complaint of abscess, cellulitis, or insect bite and receiving incision and drainage were eligible. Seven hundred seventy-eight people were assessed for eligibility and 252 met eligibility criteria. METHODS Clinician antibiotic selection and clinical outcomes were evaluated. An ad hoc outcome of test performance was performed. RESULTS We enrolled 252 patients and 126 were randomized to receive the rapid test. Methicillin-susceptible S. aureus–positive patients receiving rapid test results were prescribed beta-lactams more often than controls (absolute difference, 14.5% [95% CI, 1.1%–30.1%]) whereas methicillin-resistant S. aureus–positive patients receiving rapid test results were more often prescribed anti–methicillin-resistant S. aureus antibiotics (absolute difference, 21.5% [95% CI, 10.1%–33.0%]). There were no significant differences between the 2 groups in 1-week or 3-month clinical outcomes. CONCLUSION Availability of rapid molecular test results after incision and drainage was associated with more-targeted antibiotic selection. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01523899 PMID:26306996

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.

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

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

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.

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

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

National Estimates of Genetic Testing in Women With a History of Breast or Ovarian Cancer.

PubMed

Childers, Christopher P; Childers, Kimberly K; Maggard-Gibbons, Melinda; Macinko, James

2017-12-01

Purpose In the United States, 3.8 million women have a history of breast (BC) or ovarian cancer (OC). Up to 15% of cases are attributable to heritable mutations, which, if identified, provide critical knowledge for treatment and preventive care. It is unknown how many patients who are at high risk for these mutations have not been tested and how rates vary by risk criteria. Methods We used pooled cross-sectional data from three Cancer Control Modules (2005, 2010, 2015) of the National Health Interview Survey, a national in-person household interview survey. Eligible patients were adult females with a history of BC and/or OC meeting select 2017 National Comprehensive Cancer Network eligibility criteria on the basis of age of diagnosis and family history. Outcomes included the proportion of individuals reporting a history of discussing genetic testing with a health professional, being advised to undergo genetic testing, or undergoing genetic testing for BC or OC. Results Of 47,218 women, 2.7% had a BC history and 0.4% had an OC history. For BC, 35.6% met one or more select eligibility criteria; of those, 29.0% discussed, 20.2% were advised to undergo, and 15.3% underwent genetic testing. Testing rates for individual eligibility criteria ranged from 6.2% (relative with OC) to 18.2% (diagnosis ≤ 45 years of age). For OC, 15.1% discussed, 13.1% were advised to undergo, and 10.5% underwent testing. Using only four BC eligibility criteria and all patients with OC, an estimated 1.2 to 1.3 million individuals failed to receive testing. Conclusion Fewer than one in five individuals with a history of BC or OC meeting select National Cancer Comprehensive Network criteria have undergone genetic testing. Most have never discussed testing with a health care provider. Large national efforts are warranted to address this unmet need.

5 CFR 1600.32 - Methods for transferring eligible rollover distribution to TSP.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Methods for transferring eligible... INVESTMENT BOARD EMPLOYEE CONTRIBUTION ELECTIONS AND CONTRIBUTION ALLOCATIONS Transfers From Other Qualified Retirement Plans § 1600.32 Methods for transferring eligible rollover distribution to TSP. (a) Trustee-to...

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.

Optimizing the use of oral anticoagulant therapy for atrial fibrilation in primary care: a pharmacist-led intervention.

PubMed

Virdee, Mandeep S; Stewart, Derek

2017-02-01

Background Updated evidence-based guidelines for the management of atrial fibrillation (AF) necessitate patient review, particularly with respect to oral anticoagulants, to ensure maximum health gain around stroke prophylaxis. Objective To quantify the level of anticoagulation utilisation in patients with a CHA 2 DS 2 -VASc ≥1/≥2 (male/female) according to evidence-based guidelines and to assess the impact of a pharmacist-led intervention to optimise therapy. Setting Fifteen general medical practices in Liverpool, North-West England with a practice population of 99,129. Method GRASP-AF software was employed to interrogate patient electronic medical records to identify and risk stratify AF patients (using CHA 2 DS 2 -VASc). A pharmacist then reviewed the medical records of those of patients not anticoagulated and with a CHA 2 DS 2 -VASc ≥1/≥2 (male/female). Recommendations were discussed with a general practitioner (GP) and those patients in whom the need for anticoagulation was agreed were invited for a consultation with either the pharmacist or GP and therapy optimised where appropriate. The GPs were responsible for managing those patients referred for diagnosis confirmation or further specialist opinion. Main outcome measure Proportion of patients eligible/not eligible for anticoagulation; proportions in whom anticoagulants initiated, refused, antiplatelets discontinued. Results Five hundred and twenty-three patients (31% of patients identified with AF and a CHA 2 DS 2 -VASc ≥1/≥2 (male/female)) were not receiving an anticoagulant (26 subsequently died or left the practice leaving 497). Three hundred and eighty-two (77%) pharmacist recommendations to a GP were agreed without modification. Following outcomes of diagnostic investigations and specialist referrals, 202 (41%) patients were candidates for anticoagulation, 251 (51%) were not eligible for anticoagulation, 103 (21%) were anticoagulated (56 warfarin, 47 DOAC). Conclusion A pharmacist-led intervention re-aligned oral anticoagulant therapy to the latest evidence based guidelines for stroke prophylaxis, whilst simultaneously correcting the over-utilisation of antiplatelet therapy.

IUD knowledge and experience among family medicine residents.

PubMed

Schubert, Finn D; Herbitter, Cara; Fletcher, Jason; Gold, Marji

2015-06-01

The intrauterine device (IUD) is a highly effective contraceptive method with few contraindications; however, clinician lack of training in insertion and misconceptions about IUD risks are barriers to utilization. Previous research has shown gaps in IUD training in family medicine residency programs. An online survey addressing experience with IUD insertion, knowledge of patient eligibility and IUD risks, and intent to insert IUDs in practice was circulated to residents at 15 US family medicine residency programs. Programs were eligible to participate if they were receiving funding to enhance training in family planning and abortion care and interested in additional support to enhance IUD training. The overall response rate for the surveys was 76.1% (332/436). Experience with the levonorgestrel intrauterine system was more common than with the copper IUD. Residents performed well on knowledge questions, but many would not insert in common patient scenarios in which insertion was not contraindicated, including a history of sexually transmitted infection in the past 6 months (48.2% would not insert), a history of ectopic pregnancy (37.0%), no pap smear in the past year (30.7%), or if the patient was not in a monogamous relationship (29.2%). The vast majority of residents (88.7%) reported that they were likely or very likely to provide IUDs in their future family medicine practice. Although residents overwhelmingly expressed interest in providing IUDs after residency, our results suggest that additional clinical and didactic training is needed, particularly interventions targeted at dispelling misconceptions about patient eligibility for IUDs.

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

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.

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.

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.

Long-Term Outcomes Among Patients Who Achieve Complete or Near-Complete Responses After the Induction Phase of Bladder-Preserving Combined-Modality Therapy for Muscle-Invasive Bladder Cancer: A Pooled Analysis of NRG Oncology/RTOG 9906 and 0233

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

Mitin, Timur, E-mail: mitin@ohsu.edu; George, Asha; Zietman, Anthony L.

Purpose: To investigate the differences in outcomes among patients with muscle-invasive bladder cancer on NRG Oncology Radiation Therapy Oncology Group protocols 9906 and 0233 who achieved complete response and near-complete response after induction chemoradiation and then completed bladder-preserving therapy with chemoradiation therapy (chemo-RT) to full dose (60-64 Gy). Patients and Methods: A pooled analysis was performed on 119 eligible patients with muscle-invasive bladder cancer enrolled on NRG Oncology Radiation Therapy Oncology Group trials 9906 and 0233, who were classified as having a complete (T0) or near-complete (Ta or Tis) response after induction chemo-RT and completed consolidation with a total RT dose ofmore » at least 60 Gy. Bladder recurrence, salvage cystectomy rates, and disease-specific survival were estimated by the cumulative incidence method and bladder-intact and overall survivals by the Kaplan-Meier method. Results: Among the 119 eligible patients, 101 (85%) achieved T0, and 18 (15%) achieved Ta or Tis after induction chemo-RT and proceeded to consolidation. After a median follow-up of 5.9 years, 36 of 101 T0 patients (36%) versus 5 of 18 Ta or Tis patients (28%) experienced bladder recurrence (P=.52). Thirteen patients among complete responders eventually required late salvage cystectomy for tumor recurrence, compared with 1 patient among near-complete responders (P=.63). Disease-specific, bladder-intact, and overall survivals were not significantly different between T0 and Ta/Tis cases. Conclusions: The bladder recurrence and salvage cystectomy rates of the complete and the near-complete responders were similar. Therefore it is reasonable to recommend that patients with Ta or Tis after induction chemo-RT continue with bladder-sparing therapy with consolidation chemo-RT to full dose (60-64 Gy).« less

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.

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.

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.

Changing HIV treatment eligibility under health system constraints in sub-Saharan Africa: investment needs, population health gains, and cost-effectiveness

PubMed Central

Hontelez, Jan A.C.; Chang, Angela Y.; Ogbuoji, Osondu; de Vlas, Sake J.; Bärnighausen, Till; Atun, Rifat

2016-01-01

Objective: We estimated the investment needs, population health gains, and cost-effectiveness of different policy options for scaling-up prevention and treatment of HIV in the 10 countries that currently comprise 80% of all people living with HIV in sub-Saharan Africa (Ethiopia, Kenya, Malawi, Mozambique, Nigeria, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe). Design: We adapted the established STDSIM model to capture the health system dynamics: demand-side and supply-side constraints in the delivery of antiretroviral treatment (ART). Methods: We compared different scenarios of supply-side (i.e. health system capacity) and demand-side (i.e. health seeking behavior) constraints, and determined the impact of changing guidelines to ART eligibility at any CD4+ cell count within these constraints. Results: Continuing current scale-up would require US$178 billion by 2050. Changing guidelines to ART at any CD4+ cell count is cost-effective under all constraints tested in the model, especially in demand-side constrained health systems because earlier initiation prevents loss-to-follow-up of patients not yet eligible. Changing guidelines under current demand-side constraints would avert 1.8 million infections at US$208 per life-year saved. Conclusion: Treatment eligibility at any CD4+ cell count would be cost-effective, even under health system constraints. Excessive loss-to-follow-up and mortality in patients not eligible for treatment can be avoided by changing guidelines in demand-side constrained systems. The financial obligation for sustaining the AIDS response in sub-Saharan Africa over the next 35 years is substantial and requires strong, long-term commitment of policy-makers and donors to continue to allocate substantial parts of their budgets. PMID:27367487

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.

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.

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.

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

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.

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.

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.

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.

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.

Design, implementation and reporting strategies to reduce the instance and impact of missing patient-reported outcome (PRO) data: a systematic review

PubMed Central

Mercieca-Bebber, Rebecca; Palmer, Michael J; Brundage, Michael; Stockler, Martin R; King, Madeleine T

2016-01-01

Objectives Patient-reported outcomes (PROs) provide important information about the impact of treatment from the patients' perspective. However, missing PRO data may compromise the interpretability and value of the findings. We aimed to report: (1) a non-technical summary of problems caused by missing PRO data; and (2) a systematic review by collating strategies to: (A) minimise rates of missing PRO data, and (B) facilitate transparent interpretation and reporting of missing PRO data in clinical research. Our systematic review does not address statistical handling of missing PRO data. Data sources MEDLINE and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases (inception to 31 March 2015), and citing articles and reference lists from relevant sources. Eligibility criteria English articles providing recommendations for reducing missing PRO data rates, or strategies to facilitate transparent interpretation and reporting of missing PRO data were included. Methods 2 reviewers independently screened articles against eligibility criteria. Discrepancies were resolved with the research team. Recommendations were extracted and coded according to framework synthesis. Results 117 sources (55% discussion papers, 26% original research) met the eligibility criteria. Design and methodological strategies for reducing rates of missing PRO data included: incorporating PRO-specific information into the protocol; carefully designing PRO assessment schedules and defining termination rules; minimising patient burden; appointing a PRO coordinator; PRO-specific training for staff; ensuring PRO studies are adequately resourced; and continuous quality assurance. Strategies for transparent interpretation and reporting of missing PRO data include utilising auxiliary data to inform analysis; transparently reporting baseline PRO scores, rates and reasons for missing data; and methods for handling missing PRO data. Conclusions The instance of missing PRO data and its potential to bias clinical research can be minimised by implementing thoughtful design, rigorous methodology and transparent reporting strategies. All members of the research team have a responsibility in implementing such strategies. PMID:27311907

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

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.

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

Are patients satisfied with a web-based followup after total joint arthroplasty?

PubMed

Marsh, Jacquelyn; Bryant, Dianne; MacDonald, Steven J; Naudie, Douglas; Remtulla, Alliya; McCalden, Richard; Howard, James; Bourne, Robert; McAuley, James

2014-06-01

A web-based followup assessment may be a feasible, cost-saving alternative of tracking patient outcomes after total joint arthroplasty. However, before implementing a web-based program, it is important to determine patient satisfaction levels with the new followup method. Satisfaction with the care received is becoming an increasingly important metric, and we do not know to what degree patients are satisfied with an approach to followup that does not involve an in-person visit with their surgeons. We determined (1) patient satisfaction and (2) patients' preferences for followup method (web-based or in-person) after total joint arthroplasty. We randomized patients who were at least 12 months after primary THA or TKA to complete a web-based followup or to have their appointment at the clinic. There were 410 eligible patients contacted for the study during the recruitment period. Of these, 256 agreed to participate, and a total of 229 patients completed the study (89% of those enrolled, 56% of those potentially eligible; 111 in the usual-care group, 118 in the web-based group). Their mean age was 69 years (range, 38-86 years). There was no crossover between groups. All 229 patients completed a satisfaction questionnaire at the time of their followup appointments. Patients in the web-based group also completed a satisfaction and preference questionnaire 1 year later. Only patients from the web-based group were asked to indicate preference as they had experienced the web-based and in-person followup methods. We used descriptive statistics to summarize the satisfaction questionnaires and compared results using Pearson's chi-square test. Ninety-one patients (82.0%) in the usual-care group indicated that they were either extremely or very satisfied with the followup process compared with 90 patients (75.6%) who were in the web-based group (p < 0.01; odds ratio [OR] = 3.95; 95% CI, 1.79-8.76). Similarly, patients in the usual care group were more satisfied with the care they received from their surgeon, compared with patients in the web-based group (92.8% versus 73.9%; p < 0.01, OR = 1.37; 95% CI, 0.73-2.57). Forty-four percent of patients preferred the web-based method, 36% preferred the usual method, and 16% had no preference (p = 0.01). Our results show moderate to high satisfaction levels with a web-based followup assessment. Patients who completed the usual method of in-person followup assessment reported greater satisfaction; however, the difference was small and may not outweigh the additional cost and time-saving benefits of the web-based followup method. Level I, therapeutic study. See the Instructions for Authors for a complete description of levels of evidence.

Contemporary adjuvant polymethyl methacrylate cementation optimally limits recurrence in primary giant cell tumor of bone patients compared to bone grafting: a systematic review and meta-analysis

PubMed Central

2013-01-01

Background Reports of recurrence following restructuring of primary giant cell tumor (GCT) defects using polymethyl methacrylate (PMMA) bone cementation or allogeneic bone graft with and without adjuvants for intralesional curettage vary widely. Systematic review and meta-analysis were conducted to investigate efficacy of PMMA bone cementation and allogeneic bone grafting following intralesional curettage for GCT. Methods Medline, EMBASE, Google Scholar, and Cochrane databases were searched for studies reporting GCT of bone treatment with PMMA cementation and/or bone grafting with or without adjuvant therapy following intralesional curettage of primary GCTs. Pooled risk ratios and 95% confidence intervals (CIs) for local recurrence risks were calculated by fixed-effects methods. Results Of 1,690 relevant titles, 6 eligible studies (1,293 patients) spanning March 2008 to December 2011 were identified in published data. Treatment outcomes of PMMA-only (n = 374), bone graft-only (n = 436), PMMA with or without adjuvant (PMMA + adjuvant; n = 594), and bone graft filling with or without adjuvant (bone graft + adjuvant; n = 699) were compared. Bone graft-only patients exhibited higher recurrence rates than PMMA-treated patients (RR 2.09, 95% CI (1.64, 2.66), Overall effect: Z = 6.00; P <0.001), and bone graft + adjuvant patients exhibited higher recurrence rates than PMMA + adjuvant patients (RR 1.66, 95% CI (1.21, 2.28), Overall effect: Z = 3.15, P = 0.002). Conclusions Local recurrence was minimal in PMMA cementation patients, suggesting that PMMA is preferable for routine clinical restructuring in eligible GCT patients. Relationships between tumor characteristics, other modern adjuvants, and recurrence require further exploration. PMID:23866921

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

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.

Opt-out of Voluntary HIV Testing: A Singapore Hospital's Experience

PubMed Central

Chua, Arlene C.; Leo, Yee Sin; Cavailler, Philippe; Chu, Christine; Ng, Aloysius; Ng, Oon Tek; Krishnan, Prabha

2012-01-01

Introduction Since 2008, the Singapore Ministry of Health (MOH) has expanded HIV testing by increasing anonymous HIV test sites, as well as issuing a directive to hospitals to offer routine voluntary opt out inpatient HIV testing. We reviewed this program implemented at the end of 2008 at Tan Tock Seng Hospital (TTSH), the second largest acute care general hospital in Singapore. Methods and Findings From January 2009 to December 2010, all inpatients aged greater or equal than 21 years were screened for HIV unless they declined or were not eligible for screening. We reviewed the implementation of the Opt Out testing policy. There were a total of 93,211 admissions; 41,543 patients were included based on HIV screening program eligibility criteria. Among those included, 79% (n = 32,675) opted out of HIV screening. The overall acceptance rate was 21%. Majority of eligible patients who were tested (63%) were men. The mean age of tested patients was 52 years. The opt out rate was significantly higher among females (OR: 1.5, 95%CI: 1.4–1.6), aged >60 years (OR: 2.3, 95%CI: 2.2–2.4) and Chinese ethnicity (OR: 1.7, 95%CI:1.6–1.8). The false positive rate of the HIV screening test is 0.56%. The proportion of patients with HIV infection among those who underwent HIV screening is 0.18%. All16 confirmed HIV patients were linked to care. Conclusion The default opt-in rate of inpatient HIV testing was low at Tan Tock Seng Hospital, Singapore. Efforts to address individual HIV risk perception and campaigns against HIV stigma are needed to encourage more individuals to be tested for HIV. PMID:22493708

Intravenous magnesium for pediatric sickle cell vaso-occlusive crisis: methodological issues of a randomized controlled trial.

PubMed

Badaki-Makun, Oluwakemi; Scott, J Paul; Panepinto, Julie A; Casper, T Charles; Hillery, Cheryl A; Dean, J Michael; Brousseau, David C

2014-06-01

Multiple recent Sickle Cell Disease studies have been terminated due to poor enrollment. We developed methods to overcome past barriers and utilized these to study the efficacy and safety of intravenous magnesium for vaso-occlusive crisis (VOC). We describe the methods of the Intravenous Magnesium in Sickle Vaso-occlusive Crisis (MAGiC) trial and discuss methods used to overcome past barriers. MAGiC was a multi-center randomized double-blind placebo-controlled trial of intravenous magnesium versus normal saline for treatment of VOC. The study was a collaboration between Pediatric Hematologists and Emergency Physicians in the Pediatric Emergency Care Applied Research Network (PECARN). Eligible patients were randomized within 12 hours of receiving intravenous opioids in the Emergency Department (ED) and administered study medication every 8 hours. The primary outcome was hospital length of stay. Associated plasma studies elucidated magnesium's mechanism of action and the pathophysiology of VOC. Health-related quality of life was measured. Site-, protocol-, and patient-related barriers from prior studies were identified and addressed. Limited study staff availability, lack of collaboration with the ED, and difficulty obtaining consent were previously identified barriers. Leveraging PECARN resources, forging close collaborations between Sickle Cell Centers and EDs of participating sites, and approaching eligible patients for prior consent helped overcome these barriers. Participation in the PECARN network and establishment of collaborative arrangements between Sickle Cell Centers and their affiliated EDs are major innovative features of the MAGiC study that allowed improved subject capture. These methods could serve as a model for future studies of VOCs. © 2014 Wiley Periodicals, Inc.

Efficacy of the Pilates method for pain and disability in patients with chronic nonspecific low back pain: a systematic review with meta-analysis

PubMed Central

Miyamoto, Gisela C.; Costa, Leonardo O. P.; Cabral, Cristina M. N.

2013-01-01

Objective To systematically review the available evidence on the efficacy of the Pilates method in patients with chronic nonspecific low back pain. Method Searches were performed in MEDLINE, EMBASE, PEDro, SciELO, LILACS, CINAHL and CENTRAL in March 2013. Randomized controlled trials that tested the effectiveness of the Pilates method (against a nontreatment group, minimal intervention or other types of interventions) in adults with chronic low back pain were included regardless the language of publication. The outcome data were extracted from the eligible studies and were combined using a meta-analysis approach. Results The searches identified a total of 1,545 articles. From these, eight trials were considered eligible, and seven trials were combined in the meta-analysis. The comparison groups were as follows: Pilates versus other types of exercises (n=2 trials), and Pilates versus no treatment group or minimal intervention (n=4 trials) for short term pain; Pilates versus minimal intervention for short-term disability (n=4).We determined that Pilates was not better than other types of exercises for reducing pain intensity. However, Pilates was better than a minimal intervention for reducing short-term pain and disability (pain: pooled mean difference=1.6 points; 95% CI 1.4 to 1.8; disability: pooled mean difference=5.2 points; 95% CI 4.3 to 6.1). Conclusions Pilates was better than a minimal intervention for reducing pain and disability in patients with chronic low back pain. Pilates was not better than other types of exercise for short-term pain reduction. PMID:24346291

20 CFR 404.220 - Average-monthly-wage method.

Code of Federal Regulations, 2010 CFR

2010-04-01

... average-monthly-wage method if it is to your advantage. Being eligible for either the average-monthly-wage method or the modified average-monthly-wage method does not preclude your eligibility under the old-start...

"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.

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

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.

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.

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.

The Influence of Total Nodes Examined, Number of Positive Nodes, and Lymph Node Ratio on Survival After Surgical Resection and Adjuvant Chemoradiation for Pancreatic Cancer: A Secondary Analysis of RTOG 9704

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

Showalter, Timothy N.; Winter, Kathryn A.; Berger, Adam C., E-mail: adam.berger@jefferson.edu

2011-12-01

Purpose: Lymph node status is an important predictor of survival in pancreatic cancer. We performed a secondary analysis of Radiation Therapy Oncology Group (RTOG) 9704, an adjuvant chemotherapy and chemoradiation trial, to determine the influence of lymph node factors-number of positive nodes (NPN), total nodes examined (TNE), and lymph node ratio (LNR ratio of NPN to TNE)-on OS and disease-free survival (DFS). Patient and Methods: Eligible patients from RTOG 9704 form the basis of this secondary analysis of lymph node parameters. Actuarial estimates for OS and DFS were calculated using Kaplan-Meier methods. Cox proportional hazards models were performed to evaluatemore » associations of NPN, TNE, and LNR with OS and DFS. Multivariate Cox proportional hazards models were also performed. Results: There were 538 patients enrolled in the RTOG 9704 trial. Of these, 445 patients were eligible with lymph nodes removed. Overall median NPN was 1 (min-max, 0-18). Increased NPN was associated with worse OS (HR = 1.06, p = 0.001) and DFS (HR = 1.05, p = 0.01). In multivariate analyses, both NPN and TNE were associated with OS and DFS. TNE > 12, and >15 were associated with increased OS for all patients, but not for node-negative patients (n = 142). Increased LNR was associated with worse OS (HR = 1.01, p < 0.0001) and DFS (HR = 1.006, p = 0.002). Conclusion: In patients who undergo surgical resection followed by adjuvant chemoradiation, TNE, NPN, and LNR are associated with OS and DFS. This secondary analysis of a prospective, cooperative group trial supports the influence of these lymph node parameters on outcomes after surgery and adjuvant therapy using contemporary techniques.« less

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.

Double-Blind Maintenance Safety and Effectiveness Findings from the Treatment of Early-Onset Schizophrenia Spectrum (TEOSS) Study

ERIC Educational Resources Information Center

Findling, Robert L.; Johnson, Jacqueline L.; McClellan, Jon; Frazier, Jean A.; Vitiello, Benedetto; Hamer, Robert M.; Lieberman, Jeffrey A.; Ritz, Louise; McNamara, Nora K.; Lingler, Jacqui; Hlastala, Stefanie; Pierson, Leslie; Puglia, Madeline; Maloney, Ann E.; Kaufman, Emily Michael; Noyes, Nancy; Sikich, Linmarie

2010-01-01

Objective: To examine the long-term safety and efficacy of three antipsychotics in early-onset schizophrenia spectrum disorders. Method: Patients (8 to 19 years old) who had improved during an 8-week, randomized, double-blind acute trial of olanzapine, risperidone, or molindone (plus benztropine) were eligible to continue on the same medication…

Comparing approaches to screening for angle closure in older Chinese adults

PubMed Central

Andrews, J; Chang, D S; Jiang, Y; He, M; Foster, P J; Munoz, B; Kashiwagi, K; Friedman, D S

2012-01-01

Aims Primary angle-closure glaucoma is expected to account for nearly 50% of bilateral glaucoma blindness by 2020. This study was conducted to assess the performance of the scanning peripheral anterior chamber depth analyzer (SPAC) and limbal anterior chamber depth (LACD) as screening methods for angle closure. Methods This study assessed two clinical populations to compare SPAC, LACD, and gonioscopy: the Zhongshan Angle-closure Prevention Trial, from which 370 patients were eligible as closed-angle participants and the Liwan Eye Study, from which 72 patients were selected as open-angle controls. Eligible participants were assessed by SPAC, LACD, and gonioscopy. Results Angle status was defined by gonioscopy. Area under the receiver operating characteristic curve (AUROC) for SPAC was 0.92 (0.89–0.95) whereas AUROC for LACD was 0.94 (0.92–0.97). Using conventional cutoff points, sensitivity/specificity was 93.0%/70.8% for SPAC and 94.1%/87.5% for LACD. Sequential testing using both SPAC and LACD increased the specificity to 94.4% and decreased the sensitivity to 87.0%. Conclusion SPAC has significantly lower specificity than LACD measurement using conventional cutoffs but interpretation of the findings can be performed by modestly trained personnel. PMID:21997356

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.

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

Strategies to increase influenza vaccination rates: outcomes of a nationwide cross-sectional survey of UK general practice

PubMed Central

Teare, M Dawn; Dexter, Matthew; Siriwardena, A Niroshan; Read, Robert C

2012-01-01

Objective To identify practice strategies associated with higher flu vaccination rates in primary care. Design Logistic regression analysis of data from a cross-sectional online questionnaire. Setting 795 general practices across England. Participants 569 practice managers, 335 nursing staff and 107 general practitioners. Primary outcome measures Flu vaccination rates achieved by each practice in different groups of at-risk patients. Results 7 independent factors associated with higher vaccine uptake were identified. Having a lead staff member for planning the flu campaign and producing a written report of practice performance predicted an 8% higher vaccination rate for at-risk patients aged <65 years (OR 1.37, 95% CI 1.10 to 1.71). These strategies, plus sending a personal invitation to all eligible patients and only stopping vaccination when Quality and Outcomes Framework targets are reached, predicted a 7% higher vaccination rate (OR 1.45, 95% CI 1.10 to 1.92) in patients aged ≥65 years. Using a lead member of staff for identifying eligible patients, with either a modified manufacturer's or in-house search programme for interrogating the practice IT system, independently predicted a 4% higher vaccination rate in patients aged ≥65 years (OR 1.22, 95% CI 1.06 to 1.41/OR 1.20, 95% CI 1.03 to 1.40). The provision of flu vaccine by midwives was associated with a 4% higher vaccination rate in pregnant women (OR 1.19, 95% CI 1.02 to 1.40). Conclusions Clear leadership, effective communication about performance and methods used to identify and contact eligible patients were independently associated with significantly higher rates of flu vaccination. Financial targets appear to incentivise practices to work harder to maximise seasonal influenza vaccine uptake. The strategies identified here could help primary care providers to substantially increase their seasonal flu vaccination rates towards or even above the Chief Medical Officer's targets. PMID:22581793

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

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.

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

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.

A systematic review of teleophthalmological studies in Europe

PubMed Central

Labiris, Georgios; Panagiotopoulou, Eirini-Kanella; Kozobolis, Vassilios P.

2018-01-01

A systematic review of the recent literature regarding a series of ocular diseases involved in European telemedicine projects was performed based on the PubMed, Google Scholar and Springer databases in June 2017. Literature review returned 44 eligible studies; among them, emergency ophthalmology, diabetic retinopathy, glaucoma, age-related macular disease, cataract and retinopathy of prematurity. The majority of studies indicate teleophthalmology as a valid, reliable and cost-efficient method for care-provision in ophthalmology patients which delivers comparable outcomes to the traditional examination methods. PMID:29487825

Strategies to Support Recruitment of Patients with Life-limiting illness for Research: The Palliative Care Research Cooperative Group

PubMed Central

Hanson, Laura C.; Bull, Janet; Wessell, Kathryn; Massie, Lisa; Bennett, Rachael E.; Kutner, Jean S.; Aziz, Noreen M.; Abernethy, Amy

2014-01-01

Context The Palliative Care Research Cooperative group (PCRC) is the first clinical trials cooperative for palliative care in the United States. Objectives To describe barriers and strategies for recruitment during the inaugural PCRC clinical trial. Methods The parent study was a multi-site randomized controlled trial enrolling adults with life expectancy anticipated to be 1–6 months, randomized to discontinue statins (intervention) vs. to continue on statins (control). To study recruitment best practices, we conducted semi-structured interviews with 18 site Principal Investigators (PI) and Clinical Research Coordinators (CRC), and reviewed recruitment rates. Interviews covered 3 topics – 1) successful strategies for recruitment, 2) barriers to recruitment, and 3) optimal roles of the PI and CRC. Results All eligible site PIs and CRCs completed interviews and provided data on statin protocol recruitment. The parent study completed recruitment of n=381 patients. Site enrollment ranged from 1–109 participants, with an average of 25 enrolled per site. Five major barriers included difficulty locating eligible patients, severity of illness, family and provider protectiveness, seeking patients in multiple settings, and lack of resources for recruitment activities. Five effective recruitment strategies included systematic screening of patient lists, thoughtful messaging to make research relevant, flexible protocols to accommodate patients’ needs, support from clinical champions, and the additional resources of a trials cooperative group. Conclusion The recruitment experience from the multi-site PCRC yields new insights into methods for effective recruitment to palliative care clinical trials. These results will inform training materials for the PCRC and may assist other investigators in the field. PMID:24863152

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.

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.

The Wire-Grasping Method as a New Technique for Forceps Biopsy of Biliary Strictures: A Prospective Randomized Controlled Study of Effectiveness.

PubMed

Yamashita, Yasunobu; Ueda, Kazuki; Kawaji, Yuki; Tamura, Takashi; Itonaga, Masahiro; Yoshida, Takeichi; Maeda, Hiroki; Magari, Hirohito; Maekita, Takao; Iguchi, Mikitaka; Tamai, Hideyuki; Ichinose, Masao; Kato, Jun

2016-07-15

Transpapillary forceps biopsy is an effective diagnostic technique in patients with biliary stricture. This prospective study aimed to determine the usefulness of the wire-grasping method as a new technique for forceps biopsy. Consecutive patients with biliary stricture or irregularities of the bile duct wall were randomly allocated to either the direct or wire-grasping method group. In the wiregrasping method, forceps in the duodenum grasps a guidewire placed into the bile duct beforehand, and then, the forceps are pushed through the papilla without endoscopic sphincterotomy. In the direct method, forceps are directly pushed into the bile duct alongside a guide-wire. The primary endpoint was the success rate of obtaining specimens suitable for adequate pathological examination. In total, 32 patients were enrolled, and 28 (14 in each group) were eligible for analysis. The success rate was significantly higher using the wire-grasping method than the direct method (100% vs 50%, p=0.016). Sensitivity and accuracy for the diagnosis of cancer were comparable in patients with the successful procurement of biopsy specimens between the two methods (91% vs 83% and 93% vs 86%, respectively). The wire-grasping method is useful for diagnosing patients with biliary stricture or irregularities of the bile duct wall.

ctDNA Determination of EGFR Mutation Status in European and Japanese Patients with Advanced NSCLC: The ASSESS Study.

PubMed

Reck, Martin; Hagiwara, Koichi; Han, Baohui; Tjulandin, Sergei; Grohé, Christian; Yokoi, Takashi; Morabito, Alessandro; Novello, Silvia; Arriola, Edurne; Molinier, Olivier; McCormack, Rose; Ratcliffe, Marianne; Normanno, Nicola

2016-10-01

To offer patients with EGFR mutation-positive advanced NSCLC appropriate EGFR tyrosine kinase inhibitor treatment, mutation testing of tumor samples is required. However, tissue/cytologic samples are not always available or evaluable. The large, noninterventional diagnostic ASSESS study (NCT01785888) evaluated the utility of circulating free tumor-derived DNA (ctDNA) from plasma for EGFR mutation testing. ASSESS was conducted in 56 centers (in Europe and Japan). Eligible patients (with newly diagnosed locally advanced/metastatic treatment-naive advanced NSCLC) provided diagnostic tissue/cytologic and plasma samples. DNA extracted from tissue/cytologic samples was subjected to EGFR mutation testing using local practices; designated laboratories performed DNA extraction/mutation testing of blood samples. The primary end point was level of concordance of EGFR mutation status between matched tissue/cytologic and plasma samples. Of 1311 patients enrolled, 1288 were eligible. Concordance of mutation status in 1162 matched samples was 89% (sensitivity 46%, specificity 97%, positive predictive value 78%, and negative predictive value 90%). A group of 25 patients with apparent false-positive plasma results was overrepresented for cytologic samples, use of less sensitive tissue testing methodologies, and smoking habits associated with high EGFR mutation frequency, indicative of false-negative tumor results. In cases in which plasma and tumor samples were tested with identical highly sensitive methods, positive predictive value/sensitivity were generally improved. These real-world data suggest that ctDNA is a feasible sample for EGFR mutation analysis. It is important to conduct mutation testing of both tumor and plasma samples in specialized laboratories, using robust/sensitive methods to ensure that patients receive appropriate treatments that target the molecular features of their disease. Copyright © 2016 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

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

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

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

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

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.

Inhibiting the Hedgehog Pathway in Patients with the Basal-Cell Nevus Syndrome

PubMed Central

Tang, Jean Y.; Mackay-Wiggan, Julian M.; Aszterbaum, Michelle; Yauch, Robert L.; Lindgren, Joselyn; Chang, Kris; Coppola, Carol; Chanana, Anita M.; Marji, Jackleen; Bickers, David R.; Epstein, Ervin H.

2012-01-01

BACKGROUND Dysregulated hedgehog signaling is the pivotal molecular abnormality underlying basal-cell carcinomas. Vismodegib is a new orally administered hedgehog-pathway inhibitor that produces objective responses in locally advanced and metastatic basal-cell carcinomas. METHODS We tested the anti–basal-cell carcinoma efficacy of vismodegib in a randomized, double-blind, placebo-controlled trial in patients with the basal-cell nevus syndrome at three clinical centers from September 2009 through January 2011. The primary end point was reduction in the incidence of new basal-cell carcinomas that were eligible for surgical resection (surgically eligible) with vismodegib versus placebo after 3 months; secondary end points included reduction in the size of existing basal-cell carcinomas. RESULTS In 41 patients followed for a mean of 8 months (range, 1 to 15) after enrollment, the per-patient rate of new surgically eligible basal-cell carcinomas was lower with vismodegib than with placebo (2 vs. 29 cases per group per year, P<0.001), as was the size (percent change from baseline in the sum of the longest diameter) of existing clinically significant basal-cell carcinomas (−65% vs. −11%, P = 0.003). In some patients, all basal-cell carcinomas clinically regressed. No tumors progressed during treatment with vismodegib. Patients receiving vismodegib routinely had grade 1 or 2 adverse events of loss of taste, muscle cramps, hair loss, and weight loss. Overall, 54% of patients (14 of 26) receiving vismodegib discontinued drug treatment owing to adverse events. At 1 month, vismodegib use had reduced the hedgehog target-gene expression by basal-cell carcinoma by 90% (P<0.001) and diminished tumor-cell proliferation, but apoptosis was not affected. No residual basal-cell carcinoma was detectable in 83% of biopsy samples taken from sites of clinically regressed basal-cell carcinomas. CONCLUSIONS Vismodegib reduces the basal-cell carcinoma tumor burden and blocks growth of new basal-cell carcinomas in patients with the basal-cell nevus syndrome. The adverse events associated with treatment led to discontinuation in over half of treated patients. (Funded by Genentech and others; ClinicalTrials.gov number, NCT00957229.) PMID:22670904

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

Phase I Study of Accelerated Conformal Radiotherapy for Stage I Non–Small-Cell Lung Cancer in Patients With Pulmonary Dysfunction: CALGB 39904

PubMed Central

Bogart, Jeffrey A.; Hodgson, Lydia; Seagren, Stephen L.; Blackstock, A. William; Wang, Xiaofei; Lenox, Robert; Turrisi, Andrew T.; Reilly, John; Gajra, Ajeet; Vokes, Everett E.; Green, Mark R.

2010-01-01

Purpose The optimal treatment for medically inoperable stage I non–small-cell lung cancer (NSCLC) has not been defined. Patients and Methods Cancer and Leukemia Group B trial 39904 prospectively assessed accelerated, once-daily, three-dimensional radiotherapy for early-stage NSCLC. The primary objectives were to define the maximally accelerated course of conformal radiotherapy and to describe the short-term and long-term toxicity of therapy. Entry was limited to patients with clinical stage T1N0 or T2N0 NSCLC (< 4 cm) and pulmonary dysfunction. The nominal total radiotherapy dose remained at 70 Gy, while the number of daily fractions in each successive cohort was reduced. Results Thirty-nine eligible patients were accrued (eight patients each on cohorts 1 to 4 and seven patients on cohort 5) between January 2001 and July 2005. One grade 3 nonhematologic toxicity was observed in both cohort 3 (dyspnea) and cohort 4 (pain). The major response rate was 77%. After a median follow-up time of 53 months, the actuarial median survival time of all eligible patients was 38.5 months. Local relapse was observed in three patients. Conclusion Accelerated conformal radiotherapy was well tolerated in a high-risk population with clinical stage I NSCLC. Outcomes are comparable to prospective reports of alternative therapies, including stereotactic body radiation therapy and limited resection, with less apparent severe toxicity. Further investigation of this approach is warranted. PMID:19933904

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.

Efficacy of the Pilates method for pain and disability in patients with chronic nonspecific low back pain: a systematic review with meta-analysis.

PubMed

Miyamoto, Gisela C; Costa, Leonardo O P; Cabral, Cristina M N

2013-01-01

To systematically review the available evidence on the efficacy of the Pilates method in patients with chronic nonspecific low back pain. Searches were performed in MEDLINE, EMBASE, PEDro, SciELO, LILACS, CINAHL and CENTRAL in March 2013. Randomized controlled trials that tested the effectiveness of the Pilates method (against a nontreatment group, minimal intervention or other types of interventions) in adults with chronic low back pain were included regardless the language of publication. The outcome data were extracted from the eligible studies and were combined using a meta-analysis approach. The searches identified a total of 1,545 articles. From these, eight trials were considered eligible, and seven trials were combined in the meta-analysis. The comparison groups were as follows: Pilates versus other types of exercises (n=2 trials), and Pilates versus no treatment group or minimal intervention (n=4 trials) for short term pain; Pilates versus minimal intervention for short-term disability (n=4).We determined that Pilates was not better than other types of exercises for reducing pain intensity. However, Pilates was better than a minimal intervention for reducing short-term pain and disability (pain: pooled mean difference=1.6 points; 95% CI 1.4 to 1.8; disability: pooled mean difference=5.2 points; 95% CI 4.3 to 6.1). Pilates was better than a minimal intervention for reducing pain and disability in patients with chronic low back pain. Pilates was not better than other types of exercise for short-term pain reduction.

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.

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

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.

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.

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

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).

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.

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

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.

34 CFR 686.11 - Eligibility to receive a grant.

Code of Federal Regulations, 2012 CFR

2012-07-01

... student's eligibility for a TEACH Grant for the first payment period using either the method described in... (TEACH) GRANT PROGRAM Application Procedures § 686.11 Eligibility to receive a grant. (a) Undergraduate... student who meets the requirements of 34 CFR part 668, subpart C, is eligible to receive a TEACH Grant if...

34 CFR 686.11 - Eligibility to receive a grant.

Code of Federal Regulations, 2013 CFR

2013-07-01

... student's eligibility for a TEACH Grant for the first payment period using either the method described in... (TEACH) GRANT PROGRAM Application Procedures § 686.11 Eligibility to receive a grant. (a) Undergraduate... student who meets the requirements of 34 CFR part 668, subpart C, is eligible to receive a TEACH Grant if...

34 CFR 686.11 - Eligibility to receive a grant.

Code of Federal Regulations, 2014 CFR

2014-07-01

... student's eligibility for a TEACH Grant for the first payment period using either the method described in... (TEACH) GRANT PROGRAM Application Procedures § 686.11 Eligibility to receive a grant. (a) Undergraduate... student who meets the requirements of 34 CFR part 668, subpart C, is eligible to receive a TEACH Grant if...

Target prices for mass production of tyrosine kinase inhibitors for global cancer treatment

PubMed Central

Hill, Andrew; Gotham, Dzintars; Fortunak, Joseph; Meldrum, Jonathan; Erbacher, Isabelle; Martin, Manuel; Shoman, Haitham; Levi, Jacob; Powderly, William G; Bower, Mark

2016-01-01

Objective To calculate sustainable generic prices for 4 tyrosine kinase inhibitors (TKIs). Background TKIs have proven survival benefits in the treatment of several cancers, including chronic myeloid leukaemia, breast, liver, renal and lung cancer. However, current high prices are a barrier to treatment. Mass production of low-cost generic antiretrovirals has led to over 13 million people being on HIV/AIDS treatment worldwide. This analysis estimates target prices for generic TKIs, assuming similar methods of mass production. Methods Four TKIs with patent expiry dates in the next 5 years were selected for analysis: imatinib, erlotinib, lapatinib and sorafenib. Chemistry, dosing, published data on per-kilogram pricing for commercial transactions of active pharmaceutical ingredient (API), and quotes from manufacturers were used to estimate costs of production. Analysis included costs of excipients, formulation, packaging, shipping and a 50% profit margin. Target prices were compared with current prices. Global numbers of patients eligible for treatment with each TKI were estimated. Results API costs per kg were $347–$746 for imatinib, $2470 for erlotinib, $4671 for lapatinib, and $3000 for sorafenib. Basing on annual dose requirements, costs of formulation/packaging and a 50% profit margin, target generic prices per person-year were $128–$216 for imatinib, $240 for erlotinib, $1450 for sorafenib, and $4020 for lapatinib. Over 1 million people would be newly eligible to start treatment with these TKIs annually. Conclusions Mass generic production of several TKIs could achieve treatment prices in the range of $128–$4020 per person-year, versus current US prices of $75161–$139 138. Generic TKIs could allow significant savings and scaling-up of treatment globally, for over 1 million eligible patients. PMID:26817636

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.

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.

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.

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.

Relationship Between Time to Initiation of Antiretroviral Therapy and Treatment Outcomes: A Cohort Analysis of ART Eligible Adolescents in Zimbabwe

PubMed Central

Rehman, Andrea M.; Kranzer, Katharina; Nyathi, Mary; Van Griensven, Johan; Dixon, Mark; Ndebele, Wedu; Gunguwo, Hilary; Colebunders, Robert; Ndlovu, Mbongeni; Apollo, Tsitsi; Ferrand, Rashida A.

2017-01-01

Background: Age-specific retention challenges make antiretroviral therapy (ART) initiation in adolescents difficult, often requiring a lengthy preparation process. This needs to be balanced against the benefits of starting treatment quickly. The optimal time to initiation duration in adolescents is currently unknown. Objective: To assess the effect of time to ART initiation on mortality and loss to follow-up (LTFU) among treatment eligible adolescents. Methods: We conducted a retrospective cohort analysis among 1499 ART eligible adolescents aged ≥10 to <19 years registered in a public sector HIV program in Bulawayo, Zimbabwe, between 2004 and 2011. Hazard ratios (HR) for mortality and LTFU were calculated for different time to ART durations using multivariate Cox regression models. Results: Median follow-up duration was 1.6 years. Mortality HRs of patients who initiated at 0 to ≤7 days, >14 days to ≤1 month, >1 to ≤2 months, >2 months, and before initiation were 1.59, 1.19, 1.56, 1.08, and 0.94, respectively, compared with the reference group of >7 to ≤14 days. LTFU HRs were 1.02, 1.07, 0.85, 0.97, and 3.96, respectively. Among patients not on ART, 88% of deaths and 85% of LTFU occurred during the first 3 months after becoming ART eligible, but only 37% and 29% among adolescents on ART, respectively. Conclusions: Neither mortality or LTFU was associated with varying time to ART. The initiation process can be tailored to the adolescents' needs and individual life situations without risking to increase poor treatment outcomes. Early mortality was high despite rapid ART initiation, calling for earlier rather than faster initiation through HIV testing scale-up. PMID:28002183

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

How does age-related macular degeneration affect real-world visual ability and quality of life? A systematic review

PubMed Central

Taylor, Deanna J; Hobby, Angharad E; Binns, Alison M; Crabb, David P

2016-01-01

Objectives To review systematically the evidence of age-related macular degeneration (AMD) affecting real-world visual ability and quality of life (QoL). To explore trends in specific topics within this body of the literature. Design Systematic review. Methods A systematic literature search was carried out using MEDLINE, EMBASE, CINAHL, PsycINFO, PsychARTICLES and Health and Psychosocial Instruments for articles published up to January 2015 for studies including people diagnosed with AMD, assessing real-world visual ability or QoL as an outcome. Two researchers screened studies for eligibility. Details of eligible studies including study design, characteristics of study population and outcomes measured were recorded in a data extraction table. All included studies underwent quality appraisal using the Mixed Methods Appraisal Tool 2011 Version (MMAT). Results From 5284 studies, 123 were eligible for inclusion. A range of approaches were identified, including performance-based methods, quantitative and qualitative patient-reported outcome measures (PROMs). AMD negatively affects tasks including mobility, face recognition, perception of scenes, computer use, meal preparation, shopping, cleaning, watching TV, reading, driving and, in some cases, self-care. There is evidence for higher rates of depression among people with AMD than among community dwelling elderly. A number of adaptation strategies have been associated with AMD of varying duration. Much of the research fails to report the type of AMD studied (59% of included studies) or the duration of disease in participants (74%). Of those that do report type studied, the breakdown is as follows: wet AMD 20%, dry AMD 4% and both types 17%. Conclusions There are many publications highlighting the negative effects of AMD in various domains of life. Future research should focus on delivering some of this research knowledge into patient management and clinical trials and differentiating between the types of AMD. PMID:27913556

Communicating with Biobank Participants: Preferences for Receiving and Providing Updates to Researchers

PubMed Central

Mester, Jessica L.; Mercer, MaryBeth; Goldenberg, Aaron; Moore, Rebekah A.; Eng, Charis; Sharp, Richard R.

2015-01-01

Background Research biobanks collect biological samples and health information. Previous work shows that biobank participants desire general study updates, but preferences regarding the method or frequency of these communications have not been explored. Thus, we surveyed participants in a long-standing research biobank. Methods Eligible participants were drawn from a study of patients with personal/family history suggestive of Cowden syndrome, a poorly-recognized inherited cancer syndrome. Participants gave blood samples and access to medical records and received individual results but had no other study interactions. The biobank had 3618 participants at sampling. Survey eligibility included age ≥18 years, enrollment within the biobank’s first five years, normal PTEN analysis, and contiguous United States address. Multivariate logistic regression analyses identified predictors of participant interest in internet-based vs. offline methods and methods allowing participant-researcher interaction vs. one-way communication. Independent variables were narrowed by independent Pearson correlations by cutoff p<0.2, with p<0.02 considered significant. Results Surveys were returned from 840/1267 (66%) eligible subjects. Most (97%) wanted study updates with 92% wanting updates at least once a year. Participants preferred paper (66%) or emailed (62%) newsletter methods with 95% selecting one of these. Older, less-educated, and lower-income respondents strongly preferred offline approaches (p<0.001). Most (93%) had no concerns about receiving updates and 97% were willing to provide health updates to researchers. Conclusion Most participants were comfortable receiving and providing updated information. Demographic factors predicted communication preferences. Impact Researchers should make plans for ongoing communication early in study development and funders should support the necessary infrastructure for these efforts. PMID:25597748

Comparing Web-Based Provider-Initiated and Patient-Initiated Survivorship Care Planning for Cancer Patients: A Randomized Controlled Trial

PubMed Central

Tolbert, Elliott; Hannum, Susan M; Radhakrishnan, Archana; Zorn, Kelsey; Blackford, Amanda; Greco, Stephen; Smith, Karen; Snyder, Claire F

2016-01-01

Background Survivorship care plans (SCPs) are intended to facilitate communication and coordination between patients, oncologists, and primary care providers. Most SCP initiatives have focused on oncology providers initiating the SCP process, but time and resource barriers have limited uptake. Objective This trial compares the feasibility and value of 2 Web-based SCP tools: provider-initiated versus patient-initiated. Methods This mixed-methods study recruited clinicians from 2 academically-affiliated community oncology practices. Eligible patients were treated by a participating oncologist, had nonmetastatic cancer, completed acute treatment ≤ 2 months before enrollment, and had no evidence of disease. Patients were randomized 1:1 to either provider-initiated or patient-initiated SCPs—both are Web-based tools. We conducted qualitative interviews with providers at baseline and follow-up and with patients 2 months after enrollment. In addition, patients were administered the Preparing for Life as a (New) Survivor (PLANS) and Cancer Survivors’ Unmet Needs (CaSUN) surveys at baseline and 2 months. Results A total of 40 providers were approached for the study, of whom 13 (33%) enrolled. Providers or clinic staff required researcher assistance to identify eligible patients; 41 patients were randomized, of whom 25 completed follow-up (61%; 13 provider-initiated, 12 patient-initiated). Of the 25, 11 (44%) had initiated the SCP; 5 (20%) provided the SCP to their primary care provider. On the Preparing for Life as a (New) Survivor and Cancer Survivors’ Unmet Needs, patients in both arms tended to report high knowledge and confidence and few unmet needs. In qualitative interviews, providers and patients discussed SCPs’ value. Conclusions Regardless of patient- versus provider-initiated templates and the Web-based design of these tools, barriers to survivorship care planning persist. Further efforts should emphasize workflow functions for identifying and completing SCPs—regardless of the SCP form used. Trial Registration ClinicalTrials.gov NCT02405819; https://clinicaltrials.gov/ct2/show/NCT02405819 (Archived by WebCite at http://www.webcitation.org/6jWqcWOvK) PMID:28410187

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.

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.

Patients and Computers as Reminders to Screen for Diabetes in Family Practice

PubMed Central

Kenealy, Tim; Arroll, Bruce; Petrie, Keith J

2005-01-01

Background In New Zealand, more than 5% of people aged 50 years and older have undiagnosed diabetes; most of them attend family practitioners (FPs) at least once a year. Objectives To test the effectiveness of patients or computers as reminders to screen for diabetes in patients attending FPs. Design A randomized-controlled trial compared screening rates in 4 intervention arms: patient reminders, computer reminders, both reminders, and usual care. The trial lasted 2 months. The patient reminder was a diabetes risk self-assessment sheet filled in by patients and given to the FP during the consultation. The computer reminder was an icon that flashed only for patients considered eligible for screening. Participants One hundred and seven FPs. Measurements The primary outcome was whether each eligible patient, who attended during the trial, was or was not tested for blood glucose. Analysis was by intention to treat and allowed for clustering by FP. Results Patient reminders (odds ratio [OR] 1.72, 95% confidence interval [CI] 1.21, 2.43), computer reminders (OR 2.55, 1.68, 3.88), and both reminders (OR 1.69, 1.11, 2.59) were all effective compared with usual care. Computer reminders were more effective than patient reminders (OR 1.49, 1.07, 2.07). Patients were more likely to be screened if they visited the FP repeatedly, if patients were non-European, if they were “regular” patients of the practice, and if their FP had a higher screening rate prior to the study. Conclusions Patient and computer reminders were effective methods to increase screening for diabetes. However, the effects were not additive. PMID:16191138

Desktop software to identify patients eligible for recruitment into a clinical trial: using SARMA to recruit to the ROAD feasibility trial.

PubMed

Treweek, Shaun; Pearson, Ewan; Smith, Natalie; Neville, Ron; Sargeant, Paul; Boswell, Brian; Sullivan, Frank

2010-01-01

Recruitment to trials in primary care is often difficult, particularly when practice staff need to identify study participants with acute conditions during consultations. The Scottish Acute Recruitment Management Application (SARMA) system is linked to general practice electronic medical record (EMR) systems and is designed to provide recruitment support to multi-centre trials by screening patients against trial inclusion criteria and alerting practice staff if the patient appears eligible. For patients willing to learn more about the trial, the software allows practice staff to send the patient's contact details to the research team by text message. To evaluate the ability of the software to support trial recruitment. Software evaluation embedded in a randomised controlled trial. Five general practices in Tayside and Fife, Scotland. SARMA was used to support recruitment to a feasibility trial (the Response to Oral Agents in Diabetes, or ROAD trial) looking at users of oral therapy in diabetes. The technical performance of the software and its utility as a recruitment tool were evaluated. The software was successfully installed at four of the five general practices and recruited 11 of the 29 participants for ROAD (other methods were letter and direct invitation by a practice nurse) and had a recruitment return of 35% (11 of 31 texts sent led to a recruitment). Screen failures were relatively low (7 of 31 referred). Practice staff members were positive about the system. An automated recruitment tool can support primary care trials in Scotland and has the potential to support recruitment in other jurisdictions. It offers a low-cost supplement to other trial recruitment methods and is likely to have a much lower screen failure rate than blanket approaches such as mailshots and newspaper campaigns.

The Wire-Grasping Method as a New Technique for Forceps Biopsy of Biliary Strictures: A Prospective Randomized Controlled Study of Effectiveness

PubMed Central

Yamashita, Yasunobu; Ueda, Kazuki; Kawaji, Yuki; Tamura, Takashi; Itonaga, Masahiro; Yoshida, Takeichi; Maeda, Hiroki; Magari, Hirohito; Maekita, Takao; Iguchi, Mikitaka; Tamai, Hideyuki; Ichinose, Masao; Kato, Jun

2016-01-01

Background/Aims Transpapillary forceps biopsy is an effective diagnostic technique in patients with biliary stricture. This prospective study aimed to determine the usefulness of the wire-grasping method as a new technique for forceps biopsy. Methods Consecutive patients with biliary stricture or irregularities of the bile duct wall were randomly allocated to either the direct or wire-grasping method group. In the wire-grasping method, forceps in the duodenum grasps a guide-wire placed into the bile duct beforehand, and then, the forceps are pushed through the papilla without endoscopic sphincterotomy. In the direct method, forceps are directly pushed into the bile duct alongside a guide-wire. The primary endpoint was the success rate of obtaining specimens suitable for adequate pathological examination. Results In total, 32 patients were enrolled, and 28 (14 in each group) were eligible for analysis. The success rate was significantly higher using the wire-grasping method than the direct method (100% vs 50%, p=0.016). Sensitivity and accuracy for the diagnosis of cancer were comparable in patients with the successful procurement of biopsy specimens between the two methods (91% vs 83% and 93% vs 86%, respectively). Conclusions The wire-grasping method is useful for diagnosing patients with biliary stricture or irregularities of the bile duct wall. PMID:27021502

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.

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

Implementation of broad screening with Ebola rapid diagnostic tests in Forécariah, Guinea

PubMed Central

Nebie, Yacouba K.; Koivogui, Lamine; Abiola, Nadine; Vansteelandt, Amanda; Worrel, Mary C.; Shang, Judith; Murphy, Louise B.; Fitter, David L.; Marston, Barbara J.; Martel, Lise

2017-01-01

Background Laboratory-enhanced surveillance is critical for rapidly detecting the potential re-emergence of Ebola virus disease. Rapid diagnostic tests (RDT) for Ebola antigens could expand diagnostic capacity for Ebola virus disease. Objectives The Guinean National Coordination for Ebola Response conducted a pilot implementation to determine the feasibility of broad screening of patients and corpses with the OraQuick® Ebola RDT. Methods The implementation team developed protocols and trained healthcare workers to screen patients and corpses in Forécariah prefecture, Guinea, from 15 October to 30 November 2015. Data collected included number of consultations, number of fevers reported or measured, number of tests performed for patients or corpses and results of confirmatory RT-PCR testing. Data on malaria RDT results were collected for comparison. Feedback from Ebola RDT users was collected informally during supervision visits and forums. Results There were 3738 consultations at the 15 selected healthcare facilities; 74.6% of consultations were for febrile illness. Among 2787 eligible febrile patients, 2633 were tested for malaria and 1628 OraQuick® Ebola RDTs were performed. A total of 322 OraQuick® Ebola RDTs were conducted on corpses. All Ebola tests on eligible patients were negative. Conclusions Access to Ebola testing was expanded by the implementation of RDTs in an emergency situation. Feedback from Ebola RDT users and lessons learned will contribute to improving quality for RDT expansion. PMID:28879148

The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials.

PubMed

Donovan, Jenny L; de Salis, Isabel; Toerien, Merran; Paramasivan, Sangeetha; Hamdy, Freddie C; Blazeby, Jane M

2014-08-01

The aim of the study was to investigate how doctors considered and experienced the concept of equipoise while recruiting patients to randomized controlled trials (RCTs). In-depth interviews with 32 doctors in six publicly funded pragmatic RCTs explored their perceptions of equipoise as they undertook RCT recruitment. The RCTs varied in size, duration, type of complex intervention, and clinical specialties. Interview data were analyzed using qualitative content and thematic analytical methods derived from grounded theory and synthesized across six RCTs. All six RCTs suffered from poor recruitment. Doctors wanted to gather robust evidence but experienced considerable discomfort and emotion in relation to their clinical instincts and concerns about patient eligibility and safety. Although they relied on a sense of community equipoise to justify participation, most acknowledged having "hunches" about particular treatments and patients, some of which undermined recruitment. Surgeons experienced these issues most intensely. Training and support promoted greater confidence in equipoise and improved engagement and recruitment. Recruitment to RCTs is a fragile process and difficult for doctors intellectually and emotionally. Training and support can enable most doctors to become comfortable with key RCT concepts including equipoise, uncertainty, patient eligibility, and randomization, promoting a more resilient recruitment process in partnership with patients. Copyright © 2014 The Authors. Published by 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

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.

Introducing medication abortion into public sector facilities in KwaZulu-Natal, South Africa: an operations research study.

PubMed

Blanchard, Kelly; Lince-Deroche, Naomi; Fetters, Tamara; Devjee, Jaymala; de Menezes, Ilundi Durão; Trueman, Karen; Sudhinaraset, May; Nkonko, Errol; Moodley, Jack

2015-10-01

Examine the feasibility of introducing mifepristone-misoprostol medication abortion into existing public sector surgical abortion services in KwaZulu-Natal, South Africa. Cohort study of women offered medication or surgical abortion in a larger medication abortion introduction study. The sample included 1167 women seeking first-trimester abortion at four public sector facilities; 923 women at ≤9 weeks' gestation were eligible for medication abortion. Women who chose medication abortion took 200 mg of mifepristone orally at the facility and 800 mcg of misoprostol buccally (or vaginally if they anticipated or experienced problems with buccal administration) 48 h later at home, based on international research and global safe abortion guidelines. Women who chose surgical abortion received 600 mg of misoprostol sublingually or vaginally on the day of their procedure followed by manual vacuum aspiration 4 h later. Main outcome measures included proportion of eligible women who chose each method, proportion with complete abortion and proportion reporting adverse events. Ninety-four percent of eligible women chose medication abortion. No adverse events were reported by women who chose surgical abortion; 3% of women in the medication abortion group reported adverse events and 0.4% reported a serious adverse event. Seventy-six percent of women received a family planning method at the facility where their received their abortion, with no difference based on procedure type. Medication abortion patients were significantly more likely to report they would choose this method again (94% vs. 78%, p<.001) and recommend the method to a friend (98% vs. 84%, p<.001). Medication abortion was successfully introduced with low and acceptable rates of adverse events; most women at study facilities chose this option. Mifepristone-misoprostol medication abortion was successfully integrated into public sector surgical abortion services in South Africa and was chosen by a large majority of women who were eligible and offered choice of early termination method; access to medication abortion should be expanded in South Africa and other similar settings. Copyright © 2015 Elsevier Inc. All rights reserved.

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.

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.

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.

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

PD-L1 expression and presence of TILs in small intestinal neuroendocrine tumours

PubMed Central

Lamarca, Angela; Nonaka, Daisuke; Breitwieser, Wolfgang; Ashton, Garry; Barriuso, Jorge; McNamara, Mairéad G.; Moghadam, Sharzad; Rogan, Jane; Mansoor, Wasat; Hubner, Richard A.; Clark, Christopher; Chakrabarty, Bipasha; Valle, Juan W.

2018-01-01

Background The extent of resistance to immune surveillance in patients with well-differentiated (Wd) (grade 1/2) small-intestinal neuroendocrine tumours (Si-NETs) is unknown. Methods Patients diagnosed with Wd Si-NETs (excluding appendix, which are considered to have a different biology to other midgut NETs) were eligible. Tumoural programmed death (PD)-ligand(L) 1 (PD-L1)/PD-L2/PD-1 and tumour infiltrating lymphocytes (TILs) [presence and phenotype] were analysed in archival tissue by immunohistochemistry (IHC); reverse transcription quantitative polymerase chain reaction (RT-qPCR) was used for confirmation of IHC results. Results Of 109 patients screened, 62 were eligible: 54.8% were male; median age was 63.7 years (95%-CI 59.7-67.2); disease stage II: 4.8%, III: 40.3% and IV: 54.8%; 41.9% were functional. Analysed samples (67.1% from primary tumours, 32.9% from metastases) were of grade 1 (67.1%) or 2 (32.86%) with a median Ki-67 of 2%. From the total of 62 eligible patients, 70 and 63 samples were suitable for IHC and RT-qPCR analysis, respectively. PD-L1 expression within tumour cells and TILs were identified in 12.8% and 24.3% of samples respectively; 30% of samples showed PD-L1 expression within tumour cells and/or TILs. PD-1 was present in TILs in 22.8% of samples. Majority of samples showed significant presence of CD4+ (focal 42.86%; moderate 2.86%) and CD8+ (focal 92.86%; moderate 4.29%) TILs. IHC findings were confirmed with RT-qPCR; which showed higher expression levels of PD-L1 (p-value 0.007) and PD-1 (p-value 0.001) in samples positive for IHC compared to negative-IHC. Conclusions Thirty-percent of patients express PD-L1 within tumour cells and/or TILs. Identification of presence of TILs was also significant and warrant the investigation of immunotherapy in this setting. PMID:29599916

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

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.

Proactive recruitment of cancer patients’ social networks into a smoking cessation trial

PubMed Central

Bastian, Lori A.; Fish, Laura J.; Peterson, Bercedis L.; Biddle, Andrea K.; Garst, Jennifer; Lyna, Pauline; Molner, Stephanie; Bepler, Gerold; Kelley, Mike; Keefe, Francis J.; McBride, Colleen M.

2011-01-01

Background This report describes the characteristics associated with successful enrollment of smokers in the social networks (i.e., family and close friends) of patients with lung cancer into a smoking cessation intervention. Methods Lung cancer patients from four clinical sites were asked to complete a survey enumerating their family members and close friends who smoke, and provide permission to contact these potential participants. Family members and close friends identified as smokers were interviewed and offered participation in a smoking cessation intervention. Repeated measures logistic regression model examined characteristics associated with enrollment. Results A total of 1,062 eligible lung cancer patients were identified and 516 patients consented and completed the survey. These patients identified 1,325 potentially eligible family and close friends. Of these, 496 consented and enrolled in the smoking cessation program. Network enrollment was highest among patients who were white and had late-stage disease. Social network members enrolled were most likely to be female, a birth family, immediate family, or close friend, and live in close geographic proximity to the patient. Conclusions Proactive recruitment of smokers in the social networks of lung cancer patients is challenging. In this study, the majority of family members and friends declined to participate. Enlisting immediate female family members and friends, who live close to the patient as agents to proactively recruit other network members into smoking cessation trials could be used to extend reach of cessation interventions to patients’ social networks. Moreover, further consideration should be given to the appropriate timing of approaching network smokers to consider cessation. PMID:21382509

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.

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.

Visual Aggregate Analysis of Eligibility Features of Clinical Trials

PubMed Central

He, Zhe; Carini, Simona; Sim, Ida; Weng, Chunhua

2015-01-01

Objective To develop a method for profiling the collective populations targeted for recruitment by multiple clinical studies addressing the same medical condition using one eligibility feature each time. Methods Using a previously published database COMPACT as the backend, we designed a scalable method for visual aggregate analysis of clinical trial eligibility features. This method consists of four modules for eligibility feature frequency analysis, query builder, distribution analysis, and visualization, respectively. This method is capable of analyzing (1) frequently used qualitative and quantitative features for recruiting subjects for a selected medical condition, (2) distribution of study enrollment on consecutive value points or value intervals of each quantitative feature, and (3) distribution of studies on the boundary values, permissible value ranges, and value range widths of each feature. All analysis results were visualized using Google Charts API. Five recruited potential users assessed the usefulness of this method for identifying common patterns in any selected eligibility feature for clinical trial participant selection. Results We implemented this method as a Web-based analytical system called VITTA (Visual Analysis Tool of Clinical Study Target Populations). We illustrated the functionality of VITTA using two sample queries involving quantitative features BMI and HbA1c for conditions “hypertension” and “Type 2 diabetes”, respectively. The recruited potential users rated the user-perceived usefulness of VITTA with an average score of 86.4/100. Conclusions We contributed a novel aggregate analysis method to enable the interrogation of common patterns in quantitative eligibility criteria and the collective target populations of multiple related clinical studies. A larger-scale study is warranted to formally assess the usefulness of VITTA among clinical investigators and sponsors in various therapeutic areas. PMID:25615940

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.

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.

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

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.

Evaluating immunologic response and clinical deterioration in treatment-naïve patients initiating first-line therapies infected with HIV-1 CRF01_AE and subtype B

PubMed Central

Oyomopito, Rebecca A.; Li, Patrick CK.; Sungkanuparph, Somnuek; Phanuphak, Praphan; Tee, Kok Keng; Sirisanthana, Thira; Kantipong, Pacharee; Oka, Shinichi; Lee, Chris KC.; Kamarulzaman, Adeeba; Choi, Jun Yong; Sohn, Annette H.; Law, Matthew; Chen, Yi-Ming A.

2012-01-01

Background HIV-1 group M viruses diverge 25%–35% in envelope, important for viral attachment during infection, and 10–15% in the pol region, under selection pressure from common antiretrovirals. In Asia, subtypes B and CRF01_AE are common genotypes. Our objectives were to determine whether clinical, immunologic or virologic treatment responses differed by genotype in treatment-naïve patients initiating first-line therapy. Methods Prospectively collected, longitudinal data from patients in Thailand, Hong Kong, Malaysia, Japan, Taiwan and South Korea were provided for analysis. Covariates included demographics, hepatitis B and C coinfections, baseline CD4 T lymphocyte count and plasma HIV-1 RNA levels. Clinical deterioration (a new diagnosis of CDC category B/AIDS-defining illness or death) was assessed by proportional hazards models. Surrogate endpoints were 12-month change in CD4 cell count and virologic suppression post-therapy, evaluated by linear and logistic regression, respectively. Results Of 1105 patients, 1036 (93.8%) infected with CRF01_AE or subtype B were eligible for inclusion in clinical deterioration analyses and contributed 1546.7 person-years of follow-up (median:413 days, IQR:169–672 days). Patients >40 years demonstrated smaller immunological increases (p=0.002) and higher risk of clinical deterioration (HR=2.17; p=0.008). Patients with baseline CD4 cell counts >200 cells/μL had lower risk of clinical deterioration (HR=0.373; p=0.003). A total of 532 patients (48.1% of eligible) had CD4 counts available at baseline and 12 months post-therapy for inclusion in immunolgic analyses. Patients infected with subtype B had larger increases in CD4 counts at 12 months (p=0.024). A total of 530 patients (48.0% of eligible) were included in virologic analyses with no differences in response found between genotypes. Conclusions Results suggest that patients infected with CRF01_AE have reduced immunologic response to therapy at 12 months, compared to subtype-B-infected counterparts. Clinical deterioration was associated with low baseline CD4 counts and older age. The lack of differences in virologic outcomes suggests that all patients have opportunities for virologic suppression. PMID:23138836

Is short-term PEG-tube placement beneficial in acutely ill cognitively intact elderly patients? A proposed decision making algorithm

PubMed Central

Abraham, Rtika R; Girotra, Mohit; Wei, Jeanne Y.; Azhar, Gohar

2014-01-01

Aim Percutaneous Endoscopic Gastrostomy (PEG) tube is an important method of enteral feeding for patients who require temporary or long-term artificial nutritional support to prevent or correct disease-related malnutrition. However, there is paucity of data on the utility of short-term PEG tube placements in acute illnesses in cognitively intact elderly. Methods We present a series of seven, cognitively intact patients (age range = 72 to 93 years), who had PEG tubes placed for short periods. These patients were diagnosed with “failure to thrive” and were managed by placing a PEG tube temporarily for nutritional management. None of these patients had terminal illness or hospice eligibility and all of our patients were community dwellers. Results All our elderly patients experienced good outcomes in terms of their functional status and nutritional support. Conclusions Our series clearly supports the notion that short-term PEG tube placement in cognitively-intact elderly patients could be a successful strategy to support them during an episode of acute illness and to improve their nutritional deficits and survival. PMID:25109444

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.

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

Enhanced Identification of Eligibility for Depression Research Using an Electronic Medical Record Search Engine

PubMed Central

Seyfried, Lisa; Hanauer, David; Nease, Donald; Albeiruti, Rashad; Kavanagh, Janet; Kales, Helen C.

2009-01-01

Purpose Electronic medical records (EMR) have become part of daily practice for many physicians. Attempts have been made to apply electronic search engine technology to speed EMR review. This was a prospective, observational study to compare the speed and accuracy of electronic search engine vs. manual review of the EMR. Methods Three raters reviewed 49 cases in the EMR to screen for eligibility in a depression study using the electronic search engine (EMERSE). One week later raters received a scrambled set of the same patients including 9 distractor cases, and used manual EMR review to determine eligibility. For both methods, accuracy was assessed for the original 49 cases by comparison with a gold standard rater. Results Use of EMERSE resulted in considerable time savings; chart reviews using EMERSE were significantly faster than traditional manual review (p=0.03). The percent agreement of raters with the gold standard (e.g. concurrent validity) using either EMERSE or manual review was not significantly different. Conclusions Using a search engine optimized for finding clinical information in the free-text sections of the EMR can provide significant time savings while preserving reliability. The major power of this search engine is not from a more advanced and sophisticated search algorithm, but rather from a user interface designed explicitly to help users search the entire medical record in a way that protects health information. PMID:19560962

Prospective Comparison of Surgery Alone and Chemoradiotherapy With Selective Surgery in Resectable Squamous Cell Carcinoma of the Esophagus

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

Ariga, Hisanori; Nemoto, Kenji; Miyazaki, Shukichi

Purpose: Esophagectomy remains the mainstay treatment for esophageal cancer, although retrospective studies have suggested that chemoradiotherapy (CRT) is as effective as surgery. To determine whether CRT can substitute for surgery as the primary treatment modality, we performed a prospective direct comparison of outcomes after treatment in patients with resectable esophageal cancer who had received CRT and those who had undergone surgery. Methods and Materials: Eligible patients had resectable T1-3N0-1M0 thoracic esophageal cancer. After the surgeon explained the treatments in detail, the patients selected either CRT (CRT group) or surgery (OP group). The CRT course consisted of two cycles of cisplatinmore » and fluorouracil with split-course concurrent radiotherapy of 60Gy in 30 fractions. Patients with progressive disease during CRT and/or with persistent or recurrent disease after CRT underwent salvage resection. Results: Of 99 eligible patients with squamous cell carcinoma registered between January 2001 and December 2005, 51 selected CRT and 48 selected surgery. Of the patients in the CRT group, 13 (25.5%) underwent esophagectomy as salvage therapy. The 3- and 5-year survival rates were 78.3% and 75.7%, respectively, in the CRT group compared with 56.9% and 50.9%, respectively, in the OP group (p = 0.0169). Patients in the OP group had significantly more metastatic recurrence than those in the CRT group. Conclusions: Treatment outcomes among patients with resectable thoracic esophageal squamous cell carcinoma were comparable or superior after CRT (with salvage therapy if needed) to outcomes after surgery alone.« less

Triage for coronary artery bypass graft surgery in Canada: Do patients agree on who should come first?

PubMed Central

Shufelt, Katy; Chong, Alice; Alter, David A

2007-01-01

Background The extent to which clinical and non-clinical factors impact on the waiting-list prioritization preferences of patients in the queue is unknown. Using a series of hypothetical scenarios, the objective of this study was to examine the extent to which clinical and non-clinical factors impacted on how patients would prioritize others relative to themselves in the coronary artery bypass surgical queue. Methods Ninety-one consecutive eligible patients awaiting coronary artery bypass grafting surgery at Sunnybrook Health Sciences Centre (median waiting-time duration prior to survey of 8 weeks) were given a self-administered survey consisting of nine scenarios in which clinical and non-clinical characteristic profiles of hypothetical patients (also awaiting coronary artery bypass surgery) were varied. For each scenario, patients were asked where in the queue such hypothetical patients should be placed relative to themselves. Results The eligible response rate was 65% (59/91). Most respondents put themselves marginally ahead of a hypothetical patient with identical clinical and non-clinical characteristics as themselves. There was a strong tendency for respondents to place patients of higher clinical acuity ahead of themselves in the queue (P < 0.0001). Social independence among young individuals was a positively valued attribute (P < 0.0001), but neither age per se nor financial status, directly impacted on patients waiting-list priority preferences. Conclusion While patient perceptions generally reaffirmed a bypass surgical triage process based on principals of equity and clinical acuity, the valuation of social independence may justify further debate with regard to the inclusion of non-clinical factors in waiting-list prioritization management systems in Canada, as elsewhere. PMID:17651503

Visual aggregate analysis of eligibility features of clinical trials.

PubMed

He, Zhe; Carini, Simona; Sim, Ida; Weng, Chunhua

2015-04-01

To develop a method for profiling the collective populations targeted for recruitment by multiple clinical studies addressing the same medical condition using one eligibility feature each time. Using a previously published database COMPACT as the backend, we designed a scalable method for visual aggregate analysis of clinical trial eligibility features. This method consists of four modules for eligibility feature frequency analysis, query builder, distribution analysis, and visualization, respectively. This method is capable of analyzing (1) frequently used qualitative and quantitative features for recruiting subjects for a selected medical condition, (2) distribution of study enrollment on consecutive value points or value intervals of each quantitative feature, and (3) distribution of studies on the boundary values, permissible value ranges, and value range widths of each feature. All analysis results were visualized using Google Charts API. Five recruited potential users assessed the usefulness of this method for identifying common patterns in any selected eligibility feature for clinical trial participant selection. We implemented this method as a Web-based analytical system called VITTA (Visual Analysis Tool of Clinical Study Target Populations). We illustrated the functionality of VITTA using two sample queries involving quantitative features BMI and HbA1c for conditions "hypertension" and "Type 2 diabetes", respectively. The recruited potential users rated the user-perceived usefulness of VITTA with an average score of 86.4/100. We contributed a novel aggregate analysis method to enable the interrogation of common patterns in quantitative eligibility criteria and the collective target populations of multiple related clinical studies. A larger-scale study is warranted to formally assess the usefulness of VITTA among clinical investigators and sponsors in various therapeutic areas. Copyright © 2015 Elsevier Inc. All rights reserved.

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.

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.

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

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

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

National Quality Assessment of Early Clopidogrel Therapy in Chinese Patients With Acute Myocardial Infarction (AMI) in 2006 and 2011: Insights From the China Patient-Centered Evaluative Assessment of Cardiac Events (PEACE)–Retrospective AMI Study

PubMed Central

Zhang, Lihua; Desai, Nihar R; Li, Jing; Hu, Shuang; Wang, Qing; Li, Xi; Masoudi, Frederick A; Spertus, John A; Nuti, Sudhakar V; Wang, Sisi; Krumholz, Harlan M; Jiang, Lixin

2015-01-01

Background Early clopidogrel administration to patients with acute myocardial infarction (AMI) has been demonstrated to improve outcomes in a large Chinese trial. However, patterns of use of clopidogrel for patients with AMI in China are unknown. Methods and Results From a nationally representative sample of AMI patients from 2006 and 2011, we identified 11 944 eligible patients for clopidogrel therapy and measured early clopidogrel use, defined as initiation within 24 hours of hospital admission. Among the patients eligible for clopidogrel, the weighted rate of early clopidogrel therapy increased from 45.7% in 2006 to 79.8% in 2011 (P<0.001). In 2006 and 2011, there was significant variation in early clopidogrel use by region, ranging from 1.5% to 58.0% in 2006 (P<0.001) and 48.7% to 87.7% in 2011 (P<0.001). While early use of clopidogrel was uniformly high in urban hospitals in 2011 (median 89.3%; interquartile range: 80.1% to 94.5%), there was marked heterogeneity among rural hospitals (median 50.0%; interquartile range: 11.5% to 84.4%). Patients without reperfusion therapy and those admitted to rural hospitals were less likely to be treated with clopidogrel. Conclusions Although the use of early clopidogrel therapy in patients with AMI has increased substantially in China, there is notable wide variation across hospitals, with much less adoption in rural hospitals. Quality improvement initiatives are needed to increase consistency of early clopidogrel use for patients with AMI. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01624883. PMID:26163041

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.

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.

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.

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.

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.

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.

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.

Dental treatment injuries in the Finnish Patient Insurance Centre in 2000-2011.

PubMed

Karhunen, Sini; Virtanen, Jorma I

2016-01-01

Objective The Patient Insurance Centre in Finland reimburses patients who sustained injuries associated with medical and dental care without having to demonstrate malpractice. The aim was to analyse all dental injuries claimed through the Patient Insurance Centre over a 12-year period in order to identify factors affecting reimbursement of claims. Methods This study investigated all dental patient insurance claims in Finland during 2000-2011. The injury cases were grouped as (K00-K08) according to the International Classification of Diseases (ICD-10). Calendar year, claimant's age and gender, dental disease group and health service sector were the explanatory factors and the outcome was the decision of a claim. Multiple logistic regression modelling was used in the statistical analyses. Results The total number of decisions related to dental claims at the PIC in 2000-2011 was 7662, of which women claimed a clear majority (72%). Diseases of the pulp and periapical tissues (K04) and dental caries (K02) were the major disease groups (both 29%). Of the claims 40% were eligible for reimbursement, 27% were classified as insignificant or unavoidable injuries and 32% were rejected for other reasons. The proportion of reimbursed claims declined during the period. Patients from the private sector were more likely to be eligible for compensation than were those from the public sector (OR = 1.89, 95% CI = 1.71-2.10). Conclusions The number of dental patient insurance claims in Finland clearly rose, while the proportion of reimbursed claims declined. More claims received compensation in the private sector than in the public sector.

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.

Nutritional management of enterocutaneous fistulas.

PubMed

Slater, Rebecca

Enterocutaneous fistulas (ECF) may be challenging to manage due to the large volume of fluid losses, that may result in severe dehydration, electrolyte imbalances, malnutrition and sepsis. It is imperative that this group of patients receive adequate nutrition, as malnutrition and sepsis are the leading cause of death. ECF treatment is complex and based on various assessments, treatment can be medical/conservative management or surgical. Depending on the site of the fistula and the nutritional status of the patient, clinicians have to decide whether parenteral nutrition or enteral nutrition should be established. Fistuloclysis is a relatively novel procedure in which nutrition is provided via an enteral feeding tube placed directly into the distal lumen of a high output fistula. Although fistuloclysis is not feasible for all patients with ECF, for those that are eligible, the method appears to be an acceptable and safe method of maintaining and improving nutritional status.

Psychiatrists' follow-up of identified metabolic risk: a mixed-method analysis of outcomes and influences on practice.

PubMed

Patterson, Sue; Freshwater, Kathleen; Goulter, Nicole; Ewing, Julie; Leamon, Boyd; Choudhary, Anand; Moudgil, Vikas; Emmerson, Brett

2016-10-01

Aims and method To describe and explain psychiatrists' responses to metabolic abnormalities identified during screening. We carried out an audit of clinical records to assess rates of monitoring and follow-up practice. Semi-structured interviews with 36 psychiatrists followed by descriptive and thematic analyses were conducted. Results Metabolic abnormalities were identified in 76% of eligible patients screened. Follow-up, recorded for 59%, was variable but more likely with four or more abnormalities. Psychiatrists endorse guidelines but ambivalence about responsibility, professional norms, resource constraints and skills deficits as well as patient factors influences practice. Therapeutic optimism and desire to be a 'good doctor' supported comprehensive follow-up. Clinical implications Psychiatrists are willing to attend to physical healthcare, and obstacles to recommended practice are surmountable. Psychiatrists seek consensus among stakeholders about responsibilities and a systemic approach addressing the social determinants of health inequities. Understanding patients' expectations is critical to promoting best practice.

Programmatic Cost Evaluation of Nontargeted Opt-Out Rapid HIV Screening in the Emergency Department

PubMed Central

Haukoos, Jason S.; Campbell, Jonathan D.; Conroy, Amy A.; Hopkins, Emily; Bucossi, Meggan M.; Sasson, Comilla; Al-Tayyib, Alia A.; Thrun, Mark W.

2013-01-01

Background The Centers for Disease Control and Prevention recommends nontargeted opt-out HIV screening in healthcare settings. Cost effectiveness is critical when considering potential screening methods. Our goal was to compare programmatic costs of nontargeted opt-out rapid HIV screening with physician-directed diagnostic rapid HIV testing in an urban emergency department (ED) as part of the Denver ED HIV Opt-Out Trial. Methods This was a prospective cohort study nested in a larger quasi-experiment. Over 16 months, nontargeted rapid HIV screening (intervention) and diagnostic rapid HIV testing (control) were alternated in 4-month time blocks. During the intervention phase, patients were offered HIV testing using an opt-out approach during registration; during the control phase, physicians used a diagnostic approach to offer HIV testing to patients. Each method was fully integrated into ED operations. Direct program costs were determined using the perspective of the ED. Time-motion methodology was used to estimate personnel activity costs. Costs per patient newly-diagnosed with HIV infection by intervention phase, and incremental cost effectiveness ratios were calculated. Results During the intervention phase, 28,043 eligible patients were included, 6,933 (25%) completed testing, and 15 (0.2%, 95% CI: 0.1%–0.4%) were newly-diagnosed with HIV infection. During the control phase, 29,925 eligible patients were included, 243 (0.8%) completed testing, and 4 (1.7%, 95% CI: 0.4%–4.2%) were newly-diagnosed with HIV infection. Total annualized costs for nontargeted screening were $148,997, whereas total annualized costs for diagnostic HIV testing were $31,355. The average costs per HIV diagnosis were $9,932 and $7,839, respectively. Nontargeted HIV screening identified 11 more HIV infections at an incremental cost of $10,693 per additional infection. Conclusions Compared to diagnostic testing, nontargeted HIV screening was more costly but identified more HIV infections. More effective and less costly testing strategies may be required to improve the identification of patients with undiagnosed HIV infection in the ED. PMID:24391706

[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.

An Integrative Model of Patient-Centeredness – A Systematic Review and Concept Analysis

PubMed Central

Scholl, Isabelle; Zill, Jördis M.; Härter, Martin; Dirmaier, Jörg

2014-01-01

Background Existing models of patient-centeredness reveal a lack of conceptual clarity. This results in a heterogeneous use of the term, unclear measurement dimensions, inconsistent results regarding the effectiveness of patient-centered interventions, and finally in difficulties in implementing patient-centered care. The aim of this systematic review was to identify the different dimensions of patient-centeredness described in the literature and to propose an integrative model of patient-centeredness based on these results. Methods Protocol driven search in five databases, combined with a comprehensive secondary search strategy. All articles that include a definition of patient-centeredness were eligible for inclusion in the review and subject to subsequent content analysis. Two researchers independently first screened titles and abstracts, then assessed full texts for eligibility. In each article the given definition of patient-centeredness was coded independently by two researchers. We discussed codes within the research team and condensed them into an integrative model of patient-centeredness. Results 4707 records were identified through primary and secondary search, of which 706 were retained after screening of titles and abstracts. 417 articles (59%) contained a definition of patient-centeredness and were coded. 15 dimensions of patient-centeredness were identified: essential characteristics of clinician, clinician-patient relationship, clinician-patient communication, patient as unique person, biopsychosocial perspective, patient information, patient involvement in care, involvement of family and friends, patient empowerment, physical support, emotional support, integration of medical and non-medical care, teamwork and teambuilding, access to care, coordination and continuity of care. In the resulting integrative model the dimensions were mapped onto different levels of care. Conclusions The proposed integrative model of patient-centeredness allows different stakeholders to speak the same language. It provides a foundation for creating better measures and interventions. It can also be used to inform the development of clinical guidance documents and health policy directives, and through this support the shift towards patient-centered health care. PMID:25229640

Efficacy of Hi-Lo Evac Endotracheal Tube in Prevention of Ventilator-Associated Pneumonia in Mechanically Ventilated Poisoned Patients.

PubMed

Ghoochani Khorasani, Ahmad; Shadnia, Shahin; Mashayekhian, Mohammad; Rahimi, Mitra; Aghabiklooei, Abbas

2016-01-01

Background. Ventilator-associated pneumonia (VAP) is the most common health care-associated infection. To prevent this complication, aspiration of subglottic secretions using Hi-Lo Evac endotracheal tube (Evac ETT) is a recommended intervention. However, there are some reports on Evac ETT dysfunction. We aimed to compare the incidence of VAP (per ventilated patients) in severely ill poisoned patients who were intubated using Evac ETT versus conventional endotracheal tubes (C-ETT) in our toxicology ICU. Materials and Methods. In this clinical randomized trial, 91 eligible patients with an expected duration of mechanical ventilation of more than 48 hours were recruited and randomly assigned into two groups: (1) subglottic secretion drainage (SSD) group who were intubated by Evac ETT (n = 43) and (2) control group who were intubated by C-ETT (n = 48). Results. Of the 91 eligible patients, 56 (61.5%) were male. VAP was detected in 24 of 43 (55.8%) patients in the case group and 23 of 48 (47.9%) patients in the control group (P = 0.45). The most frequently isolated microorganisms were S. aureus (54.10%) and Acinetobacter spp. (19.68%). The incidence of VAP and ICU length of stay were not significantly different between the two groups, but duration of intubation was statistically different and was longer in the SSD group. Mortality rate was less in SSD group but without a significant difference (P = 0.68). Conclusion. The SSD procedure was performed intermittently with one-hour intervals using 10 mL syringe. Subglottic secretion drainage does not significantly reduce the incidence of VAP in patients receiving MV. This strategy appears to be ineffective in preventing VAP among ICU patients.

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

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

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.

Programmatic cost evaluation of nontargeted opt-out rapid HIV screening in the emergency department.

PubMed

Haukoos, Jason S; Campbell, Jonathan D; Conroy, Amy A; Hopkins, Emily; Bucossi, Meggan M; Sasson, Comilla; Al-Tayyib, Alia A; Thrun, Mark W

2013-01-01

The Centers for Disease Control and Prevention recommends nontargeted opt-out HIV screening in healthcare settings. Cost effectiveness is critical when considering potential screening methods. Our goal was to compare programmatic costs of nontargeted opt-out rapid HIV screening with physician-directed diagnostic rapid HIV testing in an urban emergency department (ED) as part of the Denver ED HIV Opt-Out Trial. This was a prospective cohort study nested in a larger quasi-experiment. Over 16 months, nontargeted rapid HIV screening (intervention) and diagnostic rapid HIV testing (control) were alternated in 4-month time blocks. During the intervention phase, patients were offered HIV testing using an opt-out approach during registration; during the control phase, physicians used a diagnostic approach to offer HIV testing to patients. Each method was fully integrated into ED operations. Direct program costs were determined using the perspective of the ED. Time-motion methodology was used to estimate personnel activity costs. Costs per patient newly-diagnosed with HIV infection by intervention phase, and incremental cost effectiveness ratios were calculated. During the intervention phase, 28,043 eligible patients were included, 6,933 (25%) completed testing, and 15 (0.2%, 95% CI: 0.1%-0.4%) were newly-diagnosed with HIV infection. During the control phase, 29,925 eligible patients were included, 243 (0.8%) completed testing, and 4 (1.7%, 95% CI: 0.4%-4.2%) were newly-diagnosed with HIV infection. Total annualized costs for nontargeted screening were $148,997, whereas total annualized costs for diagnostic HIV testing were $31,355. The average costs per HIV diagnosis were $9,932 and $7,839, respectively. Nontargeted HIV screening identified 11 more HIV infections at an incremental cost of $10,693 per additional infection. Compared to diagnostic testing, nontargeted HIV screening was more costly but identified more HIV infections. More effective and less costly testing strategies may be required to improve the identification of patients with undiagnosed HIV infection in the ED.

A Randomized Trial of Genetic and Environmental Risk Assessment (GERA) for Colorectal Cancer Risk in Primary Care: Trial Design and Baseline Findings

PubMed Central

Myers, Ronald E.; Manne, Sharon L.; Wilfond, Benjamin; Sifri, Randa; Ziring, Barry; Wolf, Thomas A.; Cocroft, James; Ueland, Amy; Petrich, Anett; Swan, Heidi; DiCarlo, Melissa; Weinberg, David S.

2010-01-01

Purpose This paper describes an ongoing randomized controlled trial designed to assess the impact of genetic and environmental risk assessment (GERA) on colorectal cancer (CRC) screening. Methods The trial includes asymptomatic patients who are 50-79 years and are not up-to-date with CRC screening guidelines. Patients who responded to a baseline telephone survey are randomized to a GERA or Control group. GERA Group participants meet with a nurse, decide whether to have a GERA blood test (a combination of genetic polymorphism and folate), and, if tested, receive GERA feedback. Follow-up telephone surveys are conducted at one and six months. A chart audit is performed at six months. Results Of 2,223 eligible patients, 562 (25%) have enrolled. Patients who enrolled in the study were significantly younger than those who did not (p<0.001). Participants tended to be 50-59 years (64%), female (58%), white (52%), married (51%), and have more than a high school education (67%). At baseline, most participants had some knowledge of CRC screening and GERA, viewed CRC screening favorably, and reported that they had decided to do screening. Almost half had worries and concerns about CRC. Conclusions One in four eligible primary care patients enrolled in the study. Age was negatively associated with enrollment. Prospective analyses using data for all participants will provide more definitive information on GERA uptake and the impact of GERA feedback. PMID:20828635

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/

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.

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

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.

Role of perioperative antibiotic treatment in parotid gland surgery

PubMed Central

Shkedy, Yotam; Alkan, Uri; Roman, Benjamin R.; Hilly, Ohad; Feinmesser, Raphael; Bachar, Gideon; Mizrachi, Aviram

2016-01-01

Background The value of routine prophylactic antibiotic treatment in parotid gland surgery remains undetermined. Methods A retrospective analysis was conducted of all patients who underwent parotidectomy at a university-affiliated tertiary care center between 1992 and 2009. Patients with insufficient data, specifically regarding postoperative complications and antibiotic administration were excluded from the study cohort. Results A total of 593 patients underwent parotidectomy during the study period. After exclusion, 464 patients were eligible for the study. Perioperative antibiotic treatment was given to 206 patients (45%). There was no difference in wound infection rates between patients who received perioperative antibiotic therapy and those who did not (p = .168). Multivariate analysis showed that female sex, neck dissection, and drain output >50 cc/24 hours were predictive of postoperative wound infection. Conclusion Routine prophylactic antibiotic treatment has no role in parotid gland surgery. Perioperative antibiotic treatment is recommended for patients undergoing extensive parotid gland surgery with neck dissection. PMID:26702565

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 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.

24 CFR 232.540 - Method of loan payment and amortization period.

Code of Federal Regulations, 2011 CFR

2011-04-01

... AND OTHER AUTHORITIES MORTGAGE INSURANCE FOR NURSING HOMES, INTERMEDIATE CARE FACILITIES, BOARD AND CARE HOMES, AND ASSISTED LIVING FACILITIES Eligibility Requirements-Supplemental Loans To Finance Purchase and Installation of Fire Safety Equipment Eligible Security Instruments § 232.540 Method of loan...

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.

The impact of service quality perception on patient satisfaction in Government Hospitals in Southern Saudi Arabia

PubMed Central

Alghamdi, Faris S.

2014-01-01

ABSTRACT Objectives: To examine the impact of service quality perception on patient satisfaction and determine which dimension from 5 dimensions (tangible, reliability, responsive, assurance, and empathy) has the greatest impact on patient satisfaction. Methods: A total of 183 eligible patients participated in this study. This study was conducted in Al-Baha province, Saudi Arabia from June 2013 to August 2013. We utilized the cross-sectional method, using a modified Assessment of Service Quality questionnaire to collect the data. Results: To test the study hypothesis, multiple regression analysis was carried out. Analysis of variance revealed that the overall result showed a statistically significant impact of health service quality on patient satisfaction (p=0.000). The beta-weights (beta) suggested that the empathy dimension had the greatest influence on patient satisfaction (ß=0.476), followed by tangible (ß=0.198) and responsiveness dimensions (ß=0.164). Conclusion: Patient satisfaction was influenced by health service quality, with the empathy dimension as the greatest influence on patient satisfaction. Therefore, it should be considered a priority by government hospitals to train doctors in interpersonal relationship skills to enhance the doctor-patient relationship. PMID:25316476

Effect of Corticosteroids on Pain Relief Following Root Canal Treatment: A Systematic Review.

PubMed

Iranmanesh, Foad; Parirokh, Masoud; Haghdoost, Ali Akbar; Abbott, Paul V

2017-01-01

Post-operative pain and flare-up may occur in up to 58% of patients following root canal treatment. The aim was to conduct a systematic review and a possible meta-analysis to determine the effect of glucocorticosteroid (GCS) on pain following root canal treatment. Scopus, MEDLINE and CENTRAL databases were searched up to 30 th January 2017 with broad key words. In addition, the reference lists in eligible papers and text books were hand-searched. Assessment of the eligibility of papers and data extraction were performed by two independent reviewers. Of 9891 articles, 18 were recruited as eligible papers. Most of these papers showed pain reducing effect of GCS on post-endodontic pain. Because of wide heterogeneity among the recruited papers, it was not possible to perform meta-analysis. Based on the results of this systematic review, there is a vast heterogeneity amongst articles regarding the use of GCS and their effect on post-operative pain after endodontic treatment. Further investigations with similar methods and materials are needed before meta-analysis on the effect of GCS on post-operative pain following root canal treatment can be performed .

Text messaging reminders for influenza vaccine in primary care: a cluster randomised controlled trial (TXT4FLUJAB).

PubMed

Herrett, Emily; Williamson, Elizabeth; van Staa, Tjeerd; Ranopa, Michael; Free, Caroline; Chadborn, Tim; Goldacre, Ben; Smeeth, Liam

2016-02-19

(1) To develop methods for conducting cluster randomised trials of text messaging interventions utilising routine electronic health records at low cost; (2) to assess the effectiveness of text messaging influenza vaccine reminders in increasing vaccine uptake in patients with chronic conditions. Cluster randomised trial with general practices as clusters. English primary care. 156 general practices, who used text messaging software, who had not previously used text message influenza vaccination reminders. Eligible patients were aged 18-64 in 'at-risk' groups. Practices were randomly allocated to either an intervention or standard care arm in the 2013 influenza season (September to December). Practices in the intervention arm were asked to send a text message influenza vaccination reminder to their at-risk patients under 65. Practices in the standard care arm were asked to continue their influenza campaign as planned. Practices were not blinded. Analysis was performed blinded to practice allocation. Practice-level influenza vaccine uptake among at-risk patients aged 18-64 years. 77 practices were randomised to the intervention group (76 analysed, n at-risk patients=51,121), 79 to the standard care group (79 analysed, n at-risk patients=51,136). The text message increased absolute vaccine uptake by 2.62% (95% CI -0.09% to 5.33%), p=0.058, though this could have been due to chance. Within intervention clusters, a median 21.0% (IQR 10.2% to 47.0%) of eligible patients were sent a text message. The number needed to treat was 7.0 (95% CI -0.29 to 14.3). Patient follow-up using routine electronic health records is a low cost method of conducting cluster randomised trials. Text messaging reminders are likely to result in modest improvements in influenza vaccine uptake, but levels of patients being texted need to markedly increase if text messaging reminders are to have much effect. ISRCTN48840025. 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/

COGNITIVE BEHAVIORAL THERAPY AGE EFFECTS IN CHILD AND ADOLESCENT ANXIETY: AN INDIVIDUAL PATIENT DATA METAANALYSIS

PubMed Central

Bennett, Kathryn; Manassis, Katharina; Walter, Stephen D.; Cheung, Amy; Wilansky-Traynor, Pamela; Diaz-Granados, Natalia; Duda, Stephanie; Rice, Maureen; Baer, Susan; Barrett, Paula; Bodden, Denise; Cobham, Vanessa E.; Dadds, Mark R.; Flannery-Schroeder, Ellen; Ginsburg, Golda; Heyne, David; Hudson, Jennifer L.; Kendall, Philip C.; Liber, Juliette; Warner, Carrie Masia; Mendlowitz, Sandra; Nauta, Maaike H.; Rapee, Ronald M.; Silverman, Wendy; Siqueland, Lynne; Spence, Susan H.; Utens, Elisabeth; Wood, Jeffrey J.

2015-01-01

Background Investigations of age effects on youth anxiety outcomes in randomized trials (RCTs) of cognitive behavior therapy (CBT) have failed to yield a clear result due to inadequate statistical power and methodologic weaknesses. We conducted an individual patient data metaanalysis to address this gap. Question Does age moderate CBT effect size, measured by a clinically and statistically significant interaction between age and CBT exposure? Methods All English language RCTs of CBT for anxiety in 6–19 year olds were identified using systematic review methods. Investigators of eligible trials were invited to submit their individual patient data. The anxiety disorder interview schedule (ADIS) primary diagnosis severity score was the primary outcome. Age effects were investigated using multilevel modeling to account for study level data clustering and random effects. Results Data from 17 of 23 eligible trials were obtained (74%); 16 studies and 1,171 (78%) cases were available for the analysis. No interaction between age and CBT exposure was found in a model containing age, sex, ADIS baseline severity score, and comorbid depression diagnosis (power ≥ 80%). Sensitivity analyses, including modeling age as both a categorical and continuous variable, revealed this result was robust. Conclusions Adolescents who receive CBT in efficacy research studies show benefits comparable to younger children. However, CBT protocol modifications routinely carried out by expert trial therapists may explain these findings. Adolescent CBT protocols are needed to facilitate the transportability of efficacy research effects to usual care settings where therapists may have less opportunity for CBT training and expertise development. PMID:23658135

Description of a Method to Obtain Complete One-Year Follow-Up in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

PubMed

Wooley, Jordan; Neatherlin, Holly; Mahoney, Cecile; Squiers, John J; Tabachnick, Deborah; Suresh, Mitta; Huff, Eleanor; Basra, Sukhdeep S; DiMaio, J Michael; Brown, David L; Mack, Michael J; Holper, Elizabeth M

2018-03-15

The Centers for Medicare and Medicaid Services National Coverage Determination requires centers performing transcatheter aortic valve implantation (TAVI) to report clinical outcomes up to 1 year. Many sites encounter challenges in obtaining complete 1-year follow-up. We report our process to address this challenge. A multidisciplinary process involving clinical personnel, data and quality managers, and research coordinators was initiated to collect TAVI data at baseline, 30 days, and 1 year. This process included (1) planned clinical follow-up of all patients at 30 days and 1 year; (2) query of health-care system-wide integrated data warehouse (IDW) to ascertain last date of clinical contact within the system for all patients; (3) online obituary search, cross-referencing for unique patient identifiers to determine if mortality occurred in remaining unknown patients; and (4) phone calls to remaining unknown patients or patients' families. Between January 2012 and December 2016, 744 patients underwent TAVI. All 744 patients were eligible for 30-day follow-up and 546 were eligible for 1-year follow-up. At routine clinical follow-up of 22 of 744 (3%) patients at 30 days and 180 of 546 (33%) patients at 1 year had unknown survival status. The integrated data warehouse query confirmed status-alive for an additional 1 of 22 patients at 30 days (55%) and 91 of 180 patients at 1 year (51%). Obituaries were identified for 23 of 180 additional patients at 1 year (13%). Phone contact identified the remaining unknown patients at 30 days and 1 year, resulting in 100% known survival status for patients at 30 days (744 of 744) and at 1 year (546 of 546). In conclusion, using a comprehensive approach, we were able to determine survival status in 100% of patients who underwent TAVI. Copyright © 2017 Elsevier 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

Estimating the Impact of Adding C-Reactive Protein as a Criterion for Lipid Lowering Treatment in the United States

PubMed Central

Schwartz, Lisa M.; Kerin, Kevin; Welch, H. Gilbert

2007-01-01

Background There is growing interest in using C-reactive protein (CRP) levels to help select patients for lipid lowering therapy—although this practice is not yet supported by evidence of benefit in a randomized trial. Objective To estimate the number of Americans potentially affected if a CRP criteria were adopted as an additional indication for lipid lowering therapy. To provide context, we also determined how well current lipid lowering guidelines are being implemented. Methods We analyzed nationally representative data to determine how many Americans age 35 and older meet current National Cholesterol Education Program (NCEP) treatment criteria (a combination of risk factors and their Framingham risk score). We then determined how many of the remaining individuals would meet criteria for treatment using 2 different CRP-based strategies: (1) narrow: treat individuals at intermediate risk (i.e., 2 or more risk factors and an estimated 10–20% risk of coronary artery disease over the next 10 years) with CRP > 3 mg/L and (2) broad: treat all individuals with CRP > 3 mg/L. Data source Analyses are based on the 2,778 individuals participating in the 1999–2002 National Health and Nutrition Examination Survey with complete data on cardiac risk factors, fasting lipid levels, CRP, and use of lipid lowering agents. Main measures The estimated number and proportion of American adults meeting NCEP criteria who take lipid-lowering drugs, and the additional number who would be eligible based on CRP testing. Results About 53 of the 153 million Americans aged 35 and older meet current NCEP criteria (that do not involve CRP) for lipid-lowering treatment. Sixty-five percent, however, are not currently being treated, even among those at highest risk (i.e., patients with established heart disease or its risk equivalent)—62% are untreated. Adopting the narrow and broad CRP strategies would make an additional 2.1 and 25.3 million Americans eligible for treatment, respectively. The latter strategy would make over half the adults age 35 and older eligible for lipid-lowering therapy, with most of the additionally eligible (57%) coming from the lowest NCEP heart risk category (i.e., 0–1 risk factors). Conclusion There is substantial underuse of lipid lowering therapy for American adults at high risk for coronary disease. Rather than adopting CRP-based strategies, which would make millions more lower risk patients eligible for treatment (and for whom treatment benefit has not yet been demonstrated in a randomized trial), we should ensure the treatment of currently defined high-risk patients for whom the benefit of therapy is established. PMID:17356986

Comparison of sentinel lymph node biopsy guided by blue dye with or without indocyanine green in early breast cancer.

PubMed

Shen, Songjie; Xu, Qianqian; Zhou, Yidong; Mao, Feng; Guan, Jinghong; Sun, Qiang

2018-05-22

There were limited data available for a head-to-head comparison of the identification rate and survival between the combined method of indocyanine green fluorescence and blue dye versus the traditional blue dye alone method for sentinel lymph node (SLN) biopsy. From January 2013 to December 2015, 523 eligible breast cancer patients were included in this nonrandomized prospective analysis. The identification rates, the number of SLNs identified, and the disease-free survival (DFS) between the two mapping methods were compared. The identification rate of SLNs was significantly higher with the combined method than that with the blue dye alone method (99.2% vs 93.3%, respectively; P < 0.001). The average number of SLNs identified per patient in the combined method group was 3.7 ± 2.4, which was more than that in the blue dye alone group (3.2 ± 1.6; P = 0.004). With a median follow-up of 29 months, 0.5% patients in the combined group, and 1.3% patients in the blue dye group had axillary recurrences. The DFS between the two groups showed no significant difference (P = 0.161). The combined method achieved a higher identification rate and lower rate of axillary recurrence compared to the blue dye alone method. © 2018 Wiley Periodicals, Inc.

The Remote Brief Intervention and Referral to Treatment Model: Development, Functionality, Acceptability, and Feasibility

PubMed Central

Boudreaux, Edwin D.; Haskins, Brianna; Harralson, Tina; Bernstein, Edward

2015-01-01

Background Screening, brief intervention, and referral to treatment (SBIRT) is effective for reducing risky alcohol use across a variety of medical settings. However, most programs have been unsustainable because of cost and time demands. Telehealth may alleviate on-site clinician burden. This exploratory study examines the feasibility of a new Remote Brief Intervention and Referral to Treatment (R-BIRT) model. Methods Eligible emergency department (ED) patients were enrolled into one of five models. (1) Warm Handoff: clinician-facilitated phone call during ED visit. (2) Patient Direct: patient-initiated call during visit. (3) Electronic Referral: patient contacted by R-BIRT personnel post visit. (4) Patient Choice: choice of models 1–3. (5) Modified Patient Choice: choice of models 1–2, Electronic Referral offered if 1–2 were declined. Once connected, a health coach offered assessment, counseling, and referral to treatment. Follow up assessments were conducted at 1 and 3 months. Primary outcomes measured were acceptance, satisfaction, and completion rates. Results Of 125 eligible patients, 50 were enrolled, for an acceptance rate of 40%. Feedback and satisfaction ratings were generally positive. Completion rates were 58% overall, with patients enrolled into a model wherein the consultation occurred during the ED visit, as opposed to after the visit, much more likely to complete a consultation, 90% vs. 10%, χ2 (4, N=50) = 34.8, p<0.001. Conclusions The R-BIRT offers a feasible alternative to in-person alcohol SBIRT and should be studied further. The public health impact of having accessible, sustainable, evidence-based SBIRT for substance use across a range of medical settings could be considerable. PMID:26297297

Neoadjuvant Bevacizumab, Oxaliplatin, 5-Fluorouracil, and Radiation for Rectal Cancer

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

Dipetrillo, Tom; Pricolo, Victor; Lagares-Garcia, Jorge

Purpose: To evaluate the feasibility and pathologic complete response rate of induction bevacizumab + modified infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX) 6 regimen followed by concurrent bevacizumab, oxaliplatin, continuous infusion 5-fluorouracil (5-FU), and radiation for patients with rectal cancer. Methods and Materials: Eligible patients received 1 month of induction bevacizumab and mFOLFOX6. Patients then received 50.4 Gy of radiation and concurrent bevacizumab (5 mg/kg on Days 1, 15, and 29), oxaliplatin (50 mg/m{sup 2}/week for 6 weeks), and continuous infusion 5-FU (200 mg/m{sup 2}/day). Because of gastrointestinal toxicity, the oxaliplatin dose was reduced to 40 mg/m{sup 2}/week. Resection was performedmore » 4-8 weeks after the completion of chemoradiation. Results: The trial was terminated early because of toxicity after 26 eligible patients were treated. Only 1 patient had significant toxicity (arrhythmia) during induction treatment and was removed from the study. During chemoradiation, Grade 3/4 toxicity was experienced by 19 of 25 patients (76%). The most common Grade 3/4 toxicities were diarrhea, neutropenia, and pain. Five of 25 patients (20%) had a complete pathologic response. Nine of 25 patients (36%) developed postoperative complications including infection (n = 4), delayed healing (n = 3), leak/abscess (n = 2), sterile fluid collection (n = 2), ischemic colonic reservoir (n = 1), and fistula (n = 1). Conclusions: Concurrent oxaliplatin, bevacizumab, continuous infusion 5-FU, and radiation causes significant gastrointestinal toxicity. The pathologic complete response rate of this regimen was similar to other fluorouracil chemoradiation regimens. The high incidence of postoperative wound complications is concerning and consistent with other reports utilizing bevacizumab with chemoradiation before major surgical resections.« less

Perceived Difficulty Quitting Predicts Enrollment in a Smoking-Cessation Program for Patients With Head and Neck Cancer

PubMed Central

Duffy, Sonia A.; Scheumann, Angela L.; Fowler, Karen E.; Darling-Fisher, Cynthia; Terrell, Jeffrey E.

2013-01-01

Purpose/Objectives To determine the predictors of participation in a smoking-cessation program among patients with head and neck cancer. Design 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. Setting 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. Sample 286 patients who had smoked within six months of the screening survey were eligible for a smoking-cessation intervention. Methods Descriptive statistics and bivariate and multivariate logistic regression were used to determine the independent predictors of smokers’ participation in an intervention study. Main Research Variables 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. Findings 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. Conclusions 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. Implications for Nursing 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. PMID:20439219

Early nerve repair in traumatic brachial plexus injuries in adults: treatment algorithm and first experiences.

PubMed

Pondaag, Willem; van Driest, Finn Y; Groen, Justus L; Malessy, Martijn J A

2018-01-26

OBJECTIVE The object of this study was to assess the advantages and disadvantages of early nerve repair within 2 weeks following adult traumatic brachial plexus injury (ATBPI). METHODS From 2009 onwards, the authors have strived to repair as early as possible extended C-5 to C-8 or T-1 lesions or complete loss of C-5 to C-6 or C-7 function in patients in whom there was clinical and radiological suspicion of root avulsion. Among a group of 36 patients surgically treated in the period between 2009 and 2011, surgical findings in those who had undergone treatment within 2 weeks after trauma were retrospectively compared with results in those who had undergone delayed treatment. The result of biceps muscle reanimation was the primary outcome measure. RESULTS Five of the 36 patients were referred within 2 weeks after trauma and were eligible for early surgery. Nerve ruptures and/or avulsions were found in all early cases of surgery. The advantages of early surgery are as follows: no scar formation, easy anatomical identification, and gap length reduction. Disadvantages include less-clear demarcation of vital nerve tissue and unfamiliarity with the interpretation of frozen-section examination findings. All 5 early-treatment patients recovered a biceps force rated Medical Research Council grade 4. CONCLUSIONS Preliminary results of nerve repair within 2 weeks of ATBPI are encouraging, and the benefits outweigh the drawbacks. The authors propose a decision algorithm to select patients eligible for early surgery. Referral standards for patients with ATBPI must be adapted to enable early surgery.

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.

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.

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.

New contraceptive eligibility checklists for provision of combined oral contraceptives and depot-medroxyprogesterone acetate in community-based programmes.

PubMed Central

Stang, A.; Schwingl, P.; Rivera, R.

2000-01-01

Community-based services (CBS) have long used checklists to determine eligibility for contraceptive method use, in particular for combined oral contraceptives (COCs) and the 3-month injectable contraceptive depot-medroxyprogesterone acetate (DMPA). As safety information changes, however, checklists can quickly become outdated. Inconsistent checklists and eligibility criteria often cause uneven access to contraceptives. In 1996, WHO produced updated eligibility criteria for the use of all contraceptive methods. Based on these criteria, new checklists for COCs and DMPA were developed. This article describes the new checklists and their development. Several rounds of expert review produced checklists that were correct, comprehensible and consistent with the eligibility requirements. Nevertheless, field-testing of the checklists revealed that approximately half (48%) of the respondents felt that one or more questions still needed greater comprehensibility. These findings indicated the need for a checklist guide. In March 2000, WHO convened a meeting of experts to review the medical eligibility criteria for contraceptive use. The article reflects also the resulting updated checklist. PMID:10994285

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.

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%.

U.S. Medical Eligibility Criteria for Contraceptive Use, 2016.

PubMed

Curtis, Kathryn M; Tepper, Naomi K; Jatlaoui, Tara C; Berry-Bibee, Erin; Horton, Leah G; Zapata, Lauren B; Simmons, Katharine B; Pagano, H Pamela; Jamieson, Denise J; Whiteman, Maura K

2016-07-29

The 2016 U.S. Medical Eligibility Criteria for Contraceptive Use (U.S. MEC) comprises recommendations for the use of specific contraceptive methods by women and men who have certain characteristics or medical conditions. These recommendations for health care providers were updated by CDC after review of the scientific evidence and consultation with national experts who met in Atlanta, Georgia, during August 26-28, 2015. The information in this report updates the 2010 U.S. MEC (CDC. U.S. medical eligibility criteria for contraceptive use, 2010. MMWR 2010:59 [No. RR-4]). Notable updates include the addition of recommendations for women with cystic fibrosis, women with multiple sclerosis, and women receiving certain psychotropic drugs or St. John's wort; revisions to the recommendations for emergency contraception, including the addition of ulipristal acetate; and revisions to the recommendations for postpartum women; women who are breastfeeding; women with known dyslipidemias, migraine headaches, superficial venous disease, gestational trophoblastic disease, sexually transmitted diseases, and human immunodeficiency virus; and women who are receiving antiretroviral therapy. The recommendations in this report are intended to assist health care providers when they counsel women, men, and couples about contraceptive method choice. Although these recommendations are meant to serve as a source of clinical guidance, health care providers should always consider the individual clinical circumstances of each person seeking family planning services. This report is not intended to be a substitute for professional medical advice for individual patients. Persons should seek advice from their health care providers when considering family planning options.

Quantification of bone strength by intraoperative torque measurement: a technical note.

PubMed

Suhm, Norbert; Haenni, Markus; Schwyn, Ronald; Hirschmann, Michael; Müller, Andreas Marc

2008-06-01

Bone strength describes the resistance of bone against mechanical failure. Bone strength depends on both the amount of bone and the bone's quality, and the bone strength may be looked upon as a relevant parameter to judge an osteosynthesis' stability. Information about bone strength was barely available intraoperatively in the past. The previous work of our group reported on development and laboratory evaluation of mechanical torque measurement as a method for the intraoperative quantification of bone strength. With the clinical series presented here we intend to verify that the im gesamten Text DensiProbe instrumentation for intraoperative torque measurement and the related measurement method are eligible for intraoperative use based on the following criteria: application of the method may not create complications, the measurement can be performed by the surgeon himself and may only cause a limited increase in the procedure time. From December 2006 until May 2007 ten patients with a pertrochanteric femoral fracture or a lateral femoral neck fracture eligible for stabilization with DHS were included in the study after having received informed consent. Any medication and comorbidity that might have influenced bone quality or bone mineral density (BMD) in these patients was documented. Bone strength was intraoperatively measured with DensiProbe. Complications that were obviously related with torque measurement were documented as well as any deviation from the suggested procedure; 6 and 12 weeks postoperative follow-up included clinical and radiological examination. The time required for torque measurement, the overall operating time and the number of persons present in the operating room were protocolled. BMD values of the contralateral femoral neck were postoperatively assessed by dual energy X-ray absorptiometry (DEXA) and compared to intraoperative peak torque values measured by DensiProbe. No major complication was observed during intraoperative application of DensiProbe by trained surgeons. The unintended extraction of the guide wire together with the torque measurement probe was reported only once and is looked upon as a minor complication. Fracture healing was uneventful in all patients. The mean time for torque measurement was 2.35 +/- 0.9 min accounting for 2.2 +/- 1.1% of total surgery time. The presence of an additional person was not required to perform torque measurement but to protocol the data. There was a tendency towards correlation between BMD values of the femoral neck and intraoperative peak torque values. The data presented clearly indicate that the DensiProbe instrumentation and measurement principle are eligible for routine intraoperative use by trained surgeons. Interpretation of possible correlations between BMD values measured by means of DEXA and the Peak Torque values assessed by DensiProbe has to be considered very carefully, because BMD and Peak Torque analyse bone at a different scale. Only within the framework of a multicenter study it will be possible to include a sufficient number of patients for calculation of the methods' predictive value towards implant failure and to verify acceptance of the method by the surgeons.

Better methods will be needed to project incomes to estimate eligibility for subsidies in health insurance exchanges.

PubMed

Graves, John A

2012-07-01

Under the Affordable Care Act, people who meet certain income eligibility criteria will be eligible for subsidies to offset costs of premiums and cost sharing for health insurance plans purchased through new health insurance exchanges. But determining the correct level of these subsidies will not be easy, because of several factors. These include the way in which eligibility will be calculated for participation in Medicaid or for subsidies through the exchanges; possibly inaccurate income projections; the use of different income time periods to determine eligibility; and fluctuations in income. I performed a simulation that shows that under the most likely methods to be used to determine eligibility for Medicaid or for receiving subsidies through exchanges, one-third of people with incomes initially judged to be below the Medicaid threshold would actually "churn" into an exchange at the end of the year. Other people would be wrongly deemed ineligible for advance subsidy payments because their projected income was too high, while still others judged eligible for subsidies would receive advance payments on those subsidies that were too high by $208 per year, on average. To reduce these errors, I recommend the adoption of a single eligibility standard based on income data derived from prior tax returns, along with generous accommodations during a given enrollment year for people who claim a change in circumstances, such as a change in income.

Hypofractionated Intensity Modulated Radiation Therapy in Combined Modality Treatment for Bladder Preservation in Elderly Patients With Invasive Bladder Cancer

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

Turgeon, Guy-Anne; Souhami, Luis, E-mail: luis.souhami@muhc.mcgill.ca; Cury, Fabio L.

2014-02-01

Purpose/Objective(s): To review our experience with bladder-preserving trimodality treatment (TMT) using hypofractionated intensity modulated radiation therapy (IMRT) for the treatment of elderly patients with muscle-invasive bladder cancer. Methods and Materials: Retrospective study of elderly patients treated with TMT using hypofractionated IMRT (50 Gy in 20 fractions) with concomitant weekly radiosensitizing chemotherapy. Eligibility criteria were as follows: age ≥70 years, a proven diagnosis of muscle-invasive transitional cell bladder carcinoma, stage T2-T3N0M0 disease, and receipt of TMT with curative intent. Response rate was assessed by cystoscopic evaluation and bladder biopsy. Results: 24 patients with a median age of 79 years were eligible.more » A complete response was confirmed in 83% of the patients. Of the remaining patients, 1 of them underwent salvage cystectomy, and no disease was found in the bladder on histopathologic assessment. After a median follow-up time of 28 months, of the patients with a complete response, 2 patients had muscle-invasive recurrence, 1 experienced locoregional failure, and 3 experienced distant metastasis. The overall and cancer-specific survival rates at 3 years were 61% and 71%, respectively. Of the surviving patients, 75% have a disease-free and functioning bladder. All patients completed hypofractionated IMRT, and 19 patients tolerated all 4 cycles of chemotherapy. Acute grade 3 gastrointestinal or genitourinary toxicities occurred in only 4% of the patients, and acute grade 3 or 4 hematologic toxicities, liver toxicities, or both were experienced by 17% of the cohort. No patient experienced grade 4 gastrointestinal or genitourinary toxicity. Conclusions: Hypofractionated IMRT with concurrent radiosensitizing chemotherapy appears to be an effective and well-tolerated curative treatment strategy in the elderly population and should be considered for patients who are not candidates for cystectomy or who wish to avoid cystectomy.« less

Method for identifying eligible individuals for a prevalence survey in the absence of a disease register or population register.

PubMed

Richardson, A K; Clarke, G; Sabel, C E; Pearson, J F; Mason, D F; Taylor, B V

2012-11-01

Identifying eligible individuals for a prevalence survey is difficult in the absence of a disease register or a national population register. To develop a method to identify and invite eligible individuals to participate in a national prevalence survey while maintaining confidentiality and complying with privacy legislation. A unique identifier (based on date of birth, sex and initials) was developed so that database holders could identify eligible individuals, notify us and invite them on our behalf to participate in a national multiple sclerosis prevalence survey while maintaining confidentiality and complying with privacy legislation. Several organisations (including central government, health and non-governmental organisations) used the method described to assign unique identifiers to individuals listed on their databases and to forward invitations and consent forms to them. The use of a unique identifier allowed us to recognise and record all the sources of identification for each individual. This prevented double counting or approaching the same individual more than once and facilitated the use of capture-recapture methods to improve the prevalence estimate. Capture-recapture analysis estimated that the method identified over 96% of eligible individuals in this prevalence survey. This method was developed and used successfully in a national prevalence survey of multiple sclerosis in New Zealand. The method may be useful for prevalence surveys of other diseases in New Zealand and for prevalence surveys in other countries with similar privacy legislation and lack of disease registers and population registers. © 2012 The Authors; Internal Medicine Journal © 2012 Royal Australasian College of Physicians.

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.

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.

Patients prefer pictures to numbers to express cardiovascular benefit from treatment.

PubMed

Goodyear-Smith, Felicity; Arroll, Bruce; Chan, Lydia; Jackson, Rod; Wells, Sue; Kenealy, Timothy

2008-01-01

This study aimed to determine which methods of expressing a preventive medication's benefit encourage patients with known cardiovascular disease to decide to take the medication and which methods patients prefer. We identified patients in Auckland, New Zealand, family practices located in areas of differing socioeconomic status who had preexisting heart disease (myocardial infarction, angina, or both) and were taking statins. The patients were interviewed about their preference for methods of expressing the benefit of a hypothetical medication. Benefits were expressed numerically (relative risk, absolute risk, number needed to treat, odds ratio, natural frequency) and graphically. Statistical testing was adjusted for practice. We interviewed 100 eligible patients, representing a 53% response rate. No matter how the risk was expressed, the majority of patients indicated they would be encouraged to take the medication. Two-thirds (68) of the patients preferred 1 method of expressing benefit over others. Of this group, 57% preferred the information presented graphically. This value was significantly greater (P <.001) than the 19% who chose the next most preferred option, relative risk. Few patients preferred absolute risk (13%) or natural frequencies (9%). Only a single patient (1%) preferred the odds ratio. None preferred number needed to treat. Ninety percent of patients responding to a question about framing preferred positive framing (description of the benefit of treatment) over negative framing (description of the harm of not being treated). Although number needed to treat is a useful tool for communicating risk and benefit to clinicians, this format was the least likely to encourage patients to take medication. As graphical representation of benefit was the method patients preferred most, consideration should be given to developing visual aids to support shared clinical decision making.

How does age-related macular degeneration affect real-world visual ability and quality of life? A systematic review.

PubMed

Taylor, Deanna J; Hobby, Angharad E; Binns, Alison M; Crabb, David P

2016-12-02

To review systematically the evidence of age-related macular degeneration (AMD) affecting real-world visual ability and quality of life (QoL). To explore trends in specific topics within this body of the literature. Systematic review. A systematic literature search was carried out using MEDLINE, EMBASE, CINAHL, PsycINFO, PsychARTICLES and Health and Psychosocial Instruments for articles published up to January 2015 for studies including people diagnosed with AMD, assessing real-world visual ability or QoL as an outcome. Two researchers screened studies for eligibility. Details of eligible studies including study design, characteristics of study population and outcomes measured were recorded in a data extraction table. All included studies underwent quality appraisal using the Mixed Methods Appraisal Tool 2011 Version (MMAT). From 5284 studies, 123 were eligible for inclusion. A range of approaches were identified, including performance-based methods, quantitative and qualitative patient-reported outcome measures (PROMs). AMD negatively affects tasks including mobility, face recognition, perception of scenes, computer use, meal preparation, shopping, cleaning, watching TV, reading, driving and, in some cases, self-care. There is evidence for higher rates of depression among people with AMD than among community dwelling elderly. A number of adaptation strategies have been associated with AMD of varying duration. Much of the research fails to report the type of AMD studied (59% of included studies) or the duration of disease in participants (74%). Of those that do report type studied, the breakdown is as follows: wet AMD 20%, dry AMD 4% and both types 17%. There are many publications highlighting the negative effects of AMD in various domains of life. Future research should focus on delivering some of this research knowledge into patient management and clinical trials and differentiating between the types of AMD. 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/.

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.

Measuring and improving cervical, breast, and colorectal cancer screening rates in a multi-site urban practice in Toronto, Canada.

PubMed

Feldman, Joshua; Davie, Sam; Kiran, Tara

2017-01-01

Our Family Health Team is located in Toronto, Canada and provides care to over 35 000 patients. Like many practices in Canada, we took an opportunistic approach to cervical, breast, and colorectal cancer screening. We wanted to shift to a proactive, population-based approach but were unable to systematically identify patients overdue for screening or calculate baseline screening rates. Our initiative had two goals: (1) to develop a method for systematically identifying patients eligible for screening and whether they were overdue and (2) to increase screening rates for cervical, breast, and colorectal cancer. Using external government data in combination with our practice's electronic medical record, we developed a process to identify patients eligible and overdue for cancer screening. After generating baseline data, we implemented an evidence-based, multifaceted intervention to improve cancer screening rates. We sent a personalized reminder letter to overdue patients, provided physicians with practice-level audit and feedback, and improved our electronic reminder function by updating charts with accurate data on the Fecal Occult Blood Test (FOBT). Following our initial intervention, we sought to maintain and further improve our screening rates by experimenting with alternative recall methods and collecting patient feedback. Screening rates significantly improved for all three cancers. Between March 2014 and December 2016, the cervical cancer screening rate increased from 60% to 71% (p<0.05), the breast cancer screening rate increased from 56% to 65% (p<0.05), and the overall colorectal screening rate increased from 59% to 70% (p<0.05). The increase in colorectal screening rates was largely due to an increase in FOBT screening from 18% to 25%, while colonoscopy screening remained relatively unchanged, shifting from 45% to 46%. We also found that patients living in low income neighbourhoods were less likely to be screened. Following our intervention, this equity gap narrowed modestly for breast and colorectal cancer but did not change for cervical cancer screening. Our future improvement efforts will be focused on reducing the gap in screening between patients living in low-income and high-income neighbourhoods while maintaining overall gains.

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.

Measurement of the potential geographic accessibility from call to definitive care for patient with acute stroke.

PubMed

Freyssenge, J; Renard, F; Schott, A M; Derex, L; Nighoghossian, N; Tazarourte, K; El Khoury, C

2018-01-12

The World Health Organization refers to stroke, the second most frequent cause of death in the world, in terms of pandemic. Present treatments are only effective within precise time windows. Only 10% of thrombolysis patients are eligible. Late assessment of the patient resulting from admission and lack of knowledge of the symptoms is the main explanation of lack of eligibility. The aim is the measurement of the time of access to treatment facilities for stroke victims, using ambulances (firemen ambulances or EMS ambulances) and private car. The method proposed analyses the potential geographic accessibility of stroke care infrastructure in different scenarios. The study allows better considering of the issues inherent to an area: difficult weather conditions, traffic congestion and failure to respect the distance limits of emergency transport. Depending on the scenario, access times vary considerably within the same commune. For example, between the first and the second scenario for cities in the north of Rhône county, there is a 10 min difference to the nearest Primary Stroke Center (PSC). For the first scenario, 90% of the population is 20 min away of the PSC and 96% for the second scenario. Likewise, depending on the modal vector (fire brigade or emergency medical service), overall accessibility from the emergency call to admission to a Comprehensive Stroke Center (CSC) can vary by as much as 15 min. The setting up of the various scenarios and modal comparison based on the calculation of overall accessibility makes this a new method for calculating potential access to care facilities. It is important to take into account the specific pathological features and the availability of care facilities for modelling. This method is innovative and recommendable for measuring accessibility in the field of health care. This study makes possible to highlight the patients' extension of care delays. Thus, this can impact the improvement of patient care and rethink the healthcare organization. Stroke is addressed here but it is applicable to other pathologies.

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

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.

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.

A Novel Form of Breast Intraoperative Radiation Therapy With CT-Guided High-Dose-Rate Brachytherapy: Results of a Prospective Phase 1 Clinical Trial

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

Showalter, Shayna L., E-mail: snl2t@virginia.edu; Petroni, Gina; Trifiletti, Daniel M.

Purpose: Existing intraoperative radiation therapy (IORT) techniques are criticized for the lack of image guided treatment planning and energy deposition with, at times, poor resultant dosimetry and low radiation dose. We pioneered a novel method of IORT that incorporates customized, computed tomography (CT)-based treatment planning and high-dose-rate (HDR) brachytherapy to overcome these drawbacks: CT-HDR-IORT. Methods and Materials: A phase 1 study was conducted to demonstrate the feasibility and safety of CT-HDR-IORT. Eligibility criteria included age ≥50 years, invasive or in situ breast cancer, tumor size <3 cm, and N0 disease. Patients were eligible before or within 30 days of breast-conserving surgery (BCS). BCSmore » was performed, and a multilumen balloon catheter was placed. CT images were obtained, a customized HDR brachytherapy plan was created, and a dose of 12.5 Gy was delivered to 1-cm depth from the balloon surface. The catheter was removed, and the skin was closed. The primary endpoints were feasibility and acute toxicity. Feasibility was defined as IORT treatment interval (time from CT acquisition until IORT completion) ≤90 minutes. The secondary endpoints included dosimetry, cosmetic outcome, quality of life, and late toxicity. Results: Twenty-eight patients were enrolled. The 6-month follow-up assessments were completed by 93% of enrollees. The median IORT treatment interval was 67.2 minutes (range, 50-108 minutes). The treatment met feasibility criteria in 26 women (93%). The dosimetric goals were met in 22 patients (79%). There were no Radiation Therapy Oncology Group grade 3+ toxicities; 6 patients (21%) experienced grade 2 events. Most patients (93%) had good/excellent cosmetic outcomes at the last follow-up visit. Conclusions: CT-HDR-IORT is feasible and safe. This promising approach for a conformal, image-based, higher-dose breast IORT is being evaluated in a phase 2 trial.« less

Initial Efficacy Results of RTOG 0319: Three-Dimensional Conformal Radiation Therapy (3D-CRT) Confined to the Region of the Lumpectomy Cavity for Stage I/ II Breast Carcinoma

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

Vicini, Frank, E-mail: fvicini@beaumont.ed; Winter, Kathryn; Wong, John

2010-07-15

Purpose: This prospective study (Radiation Therapy Oncology Group 0319) examines the use of three-dimensional conformal external beam radiotherapy (3D-CRT) to deliver accelerated partial breast irradiation (APBI). Initial data on efficacy and toxicity are presented. Methods and Materials: Patients with Stage I or II breast cancer with lesions {<=}3 cm, negative margins and with {<=}3 positive nodes were eligible. The 3D-CRT was 38.5 Gy in 3.85 Gy/fraction delivered 2x/day. Ipsilateral breast, ipsilateral nodal, contralateral breast, and distant failure (IBF, INF, CBF, DF) were estimated using the cumulative incidence method. Mastectomy-free, disease-free, and overall survival (MFS, DFS, OS) were recorded. The Nationalmore » Cancer Institute Common Terminology Criteria for Adverse Events, version 3, was used to grade acute and late toxicity. Results: Fifty-eight patients were entered and 52 patients are eligible and evaluable for efficacy. The median age of patients was 61 years with the following characteristics: 46% tumor size <1 cm; 87% invasive ductal histology; 94% American Joint Committee on Cancer Stage I; 65% postmenopausal; 83% no chemotherapy; and 71% with no hormone therapy. Median follow-up is 4.5 years (1.7-4.8). Four-year estimates (95% CI) of efficacy are: IBF 6% (0-12%) [4% within field (0-9%)]; INF 2% (0-6%); CBF 0%; DF 8% (0-15%); MFS 90% (78-96%); DFS 84% (71-92%); and OS 96% (85-99%). Only two (4%) Grade 3 toxicities were observed. Conclusions: Initial efficacy and toxicity using 3D-CRT to deliver APBI appears comparable to other experiences with similar follow-up. However, additional patients, further follow-up, and mature Phase III data are needed to evaluate the extent of application, limitations, and value of this particular form of APBI.« less

The 'Antiretrovirals, Sexual Transmission Risk and Attitudes' (ASTRA) study. Design, methods and participant characteristics.

PubMed

Speakman, Andrew; Rodger, Alison; Phillips, Andrew N; Gilson, Richard; Johnson, Margaret; Fisher, Martin; Ed Wilkins; Anderson, Jane; O'Connell, Rebecca; Lascar, Monica; Aderogba, Kazeem; Edwards, Simon; McDonnell, Jeffrey; Perry, Nicky; Sherr, Lorraine; Collins, Simon; Hart, Graham; Johnson, Anne M; Miners, Alec; Elford, Jonathan; Geretti, Anna-Maria; Burman, William J; Lampe, Fiona C

2013-01-01

Life expectancy for people diagnosed with HIV has improved dramatically however the number of new infections in the UK remains high. Understanding patterns of sexual behaviour among people living with diagnosed HIV, and the factors associated with having condom-less sex, is important for informing HIV prevention strategies and clinical care. In addition, in view of the current interest in a policy of early antiretroviral treatment (ART) for all people diagnosed with HIV in the UK, it is of particular importance to assess whether ART use is associated with increased levels of condom-less sex. In this context the ASTRA study was designed to investigate current sexual activity, and attitudes to HIV transmission risk, in a large unselected sample of HIV-infected patients under care in the UK. The study also gathered background information on demographic, socio-economic, lifestyle and disease-related characteristics, and physical and psychological symptoms, in order to identify other key factors impacting on HIV patients and the behaviours which underpin transmission. In this paper we describe the study rationale, design, methods, response rate and the demographic characteristics of the participants. People diagnosed with HIV infection attending 8 UK HIV out-patient clinics in 2011-2012 were invited to participate in the study. Those who agreed to participate completed a confidential, self-administered pen-and-paper questionnaire, and their latest CD4 count and viral load test results were recorded. During the study period, 5112 eligible patients were invited to take part in the study and 3258 completed questionnaires were obtained, representing a response rate of 64% of eligible patients. The study includes 2248 men who have sex with men (MSM), 373 heterosexual men and 637 women. Future results from ASTRA will be a key resource for understanding HIV transmission within the UK, targeting prevention efforts, and informing clinical care of individuals living with HIV.

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.

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

Neoadjuvant letrozole in postmenopausal estrogen and/or progesterone receptor positive breast cancer: A phase IIb/III trial to investigate optimal duration of preoperative endocrine therapy

PubMed Central

Krainick-Strobel, Ute E; Lichtenegger, Werner; Wallwiener, Diethelm; Tulusan, Augustinus H; Jänicke, Fritz; Bastert, Gunther; Kiesel, Ludwig; Wackwitz, Birgit; Paepke, Stefan

2008-01-01

Background In recent years, preoperative volume reduction of locally advanced breast cancers, resulting in higher rates of breast-conserving surgery (BCS), has become increasingly important also in postmenopausal women. Clinical interest has come to center on the third-generation nonsteroidal aromatase inhibitors (AIs), including letrozole, for such neoadjuvant endocrine treatment. This usually lasts 3–4 months and has been extended to up to 12 months, but optimal treatment duration has not been fully established. Methods This study was designed as a multicenter, open-label, single-arm, exploratory phase IIb/III clinical trial of letrozole 2.5 mg, one tablet daily, for 4–8 months. The primary objective was to investigate the effect of neoadjuvant treatment duration on tumor regression and BCS eligibility to identify optimal treatment duration. Tumor regression (by clinical examination, mammography, and ultrasound), shift towards BCS eligibility, and safety assessments were the main outcome measures. Standard parametric and nonparametric descriptive statistics were performed. Results Letrozole treatment was received by 32 of the enrolled 33 postmenopausal women (median (range): 67.0 (56–85) years) with unilateral, initially BCS-ineligible primary breast cancer (clinical stage ≥ T2, N0, M0). Letrozole treatment duration in the modified intent-to-treat (ITT; required 4 months' letrozole treatment) analysis population (29 patients) was 4 months in 14 patients and > 4 months in 15 patients. The respective per-protocol (PP) subgroup sizes were 14 and 11. The majority of partial or complete responses were observed at 4 months, though some beneficial responses occurred during prolonged letrozole treatment. Compared with baseline, median tumor size in the ITT population was reduced by 62.5% at Month 4 and by 70.0% at final study visit (Individual End). Similarly, in the PP population, respective reductions were 64.0% and 67.0%. Whereas initially all patients were mastectomy candidates, letrozole treatment enabled BCS (lumpectomy) in 22 ITT (75.9%) and 18 PP (72.0%) patients. Conclusion Over half of patients become BCS-eligible within 4 months of preoperative letrozole treatment. While prolonged treatment for up to 8 months can result in further tumor volume reduction in some patients, there is no clear optimum for treatment duration. Letrozole has a favorable overall safety and tolerability profile. Trial registration ClinicalTrials.gov identifier NCT00535418. PMID:18302747

Uninsured Veterans Who Will Need to Obtain Insurance Coverage Under the Patient Protection and Affordable Care Act

PubMed Central

Rosenheck, Robert

2014-01-01

Objectives. We examined the number and clinical needs of uninsured veterans, including those who will be eligible for the Medicaid expansion and health insurance exchanges in 2014. Methods. We analyzed weighted data for 8710 veterans from the 2010 National Survey of Veterans, classifying it by veterans’ age, income, household size, and insurance status. Results. Of 22 million veterans, about 7%, or more than 1.5 million, were uninsured and will need to obtain coverage by enrolling in US Department of Veterans Affairs (VA) care or the Medicaid expansion or by participating in the health insurance exchanges. Of those uninsured, 55%, or more than 800 000, are likely eligible for the Medicaid expansion if states implement it. Compared with veterans with any health coverage, those who were uninsured were younger and more likely to be single, Black, and low income and to have been deployed to Iraq and Afghanistan. Conclusions. The Patient Protection and Affordable Care Act is likely to have a considerable impact on uninsured veterans, which may have implications for the VA, the Medicaid expansion, and the health insurance exchanges. PMID:24432934

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.

Studying Physician-Patient Communication in the Acute Care Setting: The Hospitalist Rapport Study

PubMed Central

Anderson, Wendy G.; Winters, Kathryn; Arnold, Robert M.; Puntillo, Kathleen A.; White, Douglas B.; Auerbach, Andrew D.

2010-01-01

Objective To assess the feasibility of studying physician-patient communication in the acute care setting. Methods We recruited hospitalist physicians and patients from two hospitals within a university system and audio-recorded their first encounter. Recruitment, data collection, and challenges encountered were tracked. Results Thirty-two physicians consented (rate 91%). Between August 2008 and March 2009, 441 patients were referred, 210 (48%) were screened, and 119 (66% of 179 eligible) consented. We audio-recorded encounters of 80 patients with 27 physicians. Physicians’ primary concern about participation was interference with their workflow. Addressing their concerns and building the protocol around their schedules facilitated participation. Challenges unique to the acute care setting were: 1) extremely limited time for patient identification, screening, and enrollment during which patients were ill and busy with clinical care activities, and 2) little advance knowledge of when physician-patient encounters would occur. Employing a full-time study coordinator mitigated these challenges. Conclusion Physician concerns for participating in communication studies are similar in ambulatory and acute care settings. The acute care setting presents novel challenges for patient recruitment and data collection. Practice Implications These methods should be used to study provider-patient communication in acute care settings. Future work should test strategies to increase patient enrollment. PMID:20444569

RECQ1 A159C Polymorphism Is Associated With Overall Survival of Patients With Resected Pancreatic Cancer: A Replication Study in NRG Oncology Radiation Therapy Oncology Group 9704

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

Li, Donghui, E-mail: dli@mdanderson.org; Moughan, Jennifer; Crane, Christopher

Purpose: To confirm whether a previously observed association between RECQ1 A159C variant and clinical outcome of resectable pancreatic cancer patients treated with preoperative chemoradiation is reproducible in another patient population prospectively treated with postoperative chemoradiation. Methods and Materials: Patients were selected, according to tissue availability, from eligible patients with resected pancreatic cancer who were enrolled on the NRG Oncology Radiation Therapy Oncology Group 9704 trial of 5-fluorouacil (5-FU)-based chemoradiation preceded and followed by 5-FU or gemcitabine. Deoxyribonucleic acid was extracted from paraffin-embedded tissue sections, and genotype was determined using the Taqman method. The correlation between genotype and overall survival wasmore » analyzed using a Kaplan-Meier plot, log-rank test, and multivariate Cox proportional hazards models. Results: In the 154 of the study's 451 eligible patients with evaluable tissue, genotype distribution followed Hardy-Weinberg equilibrium (ie, 37% had genotype AA, 43% AC, and 20% CC). The RECQ1 variant AC/CC genotype carriers were associated with being node positive compared with the AA carrier (P=.03). The median survival times (95% confidence interval [CI]) for AA, AC, and CC carriers were 20.6 (16.3-26.1), 18.8 (14.2-21.6), and 14.2 (10.3-21.0) months, respectively. On multivariate analysis, patients with the AC/CC genotypes were associated with worse survival than patients with the AA genotype (hazard ratio [HR] 1.54, 95% CI 1.07-2.23, P=.022). This result seemed slightly stronger for patients on the 5-FU arm (n=82) (HR 1.64, 95% CI 0.99-2.70, P=.055) than for patients on the gemcitabine arm (n=72, HR 1.46, 95% CI 0.81-2.63, P=.21). Conclusions: Results of this study suggest that the RECQ1 A159C genotype may be a prognostic or predictive factor for resectable pancreatic cancer patients who are treated with adjuvant 5-FU before and after 5-FU-based chemoradiation. Further study is needed in patients treated with gemcitabine to determine whether an association exists.« less

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 %.

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.

Feasibility of an Immersive Virtual Reality Intervention for Hospitalized Patients: An Observational Cohort Study

PubMed Central

2016-01-01

Background Virtual reality (VR) offers immersive, realistic, three-dimensional experiences that “transport” users to novel environments. Because VR is effective for acute pain and anxiety, it may have benefits for hospitalized patients; however, there are few reports using VR in this setting. Objective The aim was to evaluate the acceptability and feasibility of VR in a diverse cohort of hospitalized patients. Methods We assessed the acceptability and feasibility of VR in a cohort of patients admitted to an inpatient hospitalist service over a 4-month period. We excluded patients with motion sickness, stroke, seizure, dementia, nausea, and in isolation. Eligible patients viewed VR experiences (eg, ocean exploration; Cirque du Soleil; tour of Iceland) with Samsung Gear VR goggles. We then conducted semistructured patient interview and performed statistical testing to compare patients willing versus unwilling to use VR. Results We evaluated 510 patients; 423 were excluded and 57 refused to participate, leaving 30 participants. Patients willing versus unwilling to use VR were younger (mean 49.1, SD 17.4 years vs mean 60.2, SD 17.7 years; P=.01); there were no differences by sex, race, or ethnicity. Among users, most reported a positive experience and indicated that VR could improve pain and anxiety, although many felt the goggles were uncomfortable. Conclusions Most inpatient users of VR described the experience as pleasant and capable of reducing pain and anxiety. However, few hospitalized patients in this “real-world” series were both eligible and willing to use VR. Consistent with the “digital divide” for emerging technologies, younger patients were more willing to participate. Future research should evaluate the impact of VR on clinical and resource outcomes. ClinicalTrial Clinicaltrials.gov NCT02456987; https://clinicaltrials.gov/ct2/show/NCT02456987 (Archived by WebCite at http://www.webcitation.org/6iFIMRNh3) PMID:27349654

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.

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.

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...

Efficacy of abbreviated Stanford V chemotherapy and involved-field radiotherapy in early-stage Hodgkin lymphoma: mature results of the G4 trial.

PubMed

Advani, R H; Hoppe, R T; Baer, D; Mason, J; Warnke, R; Allen, J; Daadi, S; Rosenberg, S A; Horning, S J

2013-04-01

To assess the efficacy of an abbreviated Stanford V regimen in patients with early-stage Hodgkin lymphoma (HL). PATIENTS AND METHODS PATIENTS: with untreated nonbulky stage I-IIA supradiaphragmatic HL were eligible for the G4 study. Stanford V chemotherapy was administered for 8 weeks followed by radiation therapy (RT) 30 Gy to involved fields (IF). Freedom from progression (FFP), disease-specific survival (DSS) and overall survival (OS) were estimated. All 87 enrolled patients completed the abbreviated regimen. At a median follow-up of 10 years, FFP, DSS and OS are 94%, 99% and 94%, respectively. Therapy was well tolerated with no treatment-related deaths. Mature results of the abbreviated Stanford V regimen in nonbulky early-stage HL are excellent and comparable to the results from other contemporary therapies.

Innovative Strategies Designed to Improve Adult Pneumococcal Immunizations in Safety Net Patient-Centered Medical Homes.

PubMed

Park, Nina J; Sklaroff, Laura Myerchin; Gross-Schulman, Sandra; Hoang, Khathy; Tran, Helen; Campa, David; Scheib, Geoffrey; Guterman, Jeffrey J

2016-08-01

Streptococcus pneumoniae is a principal cause of serious illness, including bacteremia, meningitis, and pneumonia, worldwide. Pneumococcal immunization is proven to reduce morbidity and mortality in high-risk adult and elderly populations. Current pneumococcal vaccination practices are suboptimal in part because of recommendation complexity, the high cost of provider-driven immunization interventions, and outreach methods that are not patient-centric. These barriers are amplified within the safety net. This paper identifies efforts by the Los Angeles County Department of Health Services to increase pneumococcal immunization rates for adult indigent patient populations. A 4-part approach will be used to increase vaccination rates: (1) protocol driven care, (2) staff education, (3) electronic identification of eligible patients, and (4) automated patient outreach and scheduling. The proposed analytics plan and potential for scalability are described. (Population Health Management 2016;19:240-247).

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.

The recruitment of patients to trials in head and neck cancer: a qualitative study of the EaStER trial of treatments for early laryngeal cancer.

PubMed

Hamilton, D W; de Salis, I; Donovan, J L; Birchall, M

2013-08-01

We aimed to investigate the factors contributing to poor recruitment to the EaStER trial "Early Stage glottic cancer: Endoscopic excision or Radiotherapy" feasibility study. We performed a prospective qualitative assessment of the EaStER trial at three centres to investigate barriers to recruitment and implement changes. Methods used included semi-structured interviews, focus groups and audio-recordings of recruitment encounters. First, surgeons and recruiters did not all accept the primary outcome as the rationale for the trial. Surgeons did not always adhere to the trial eligibility criteria leading to variations between centres in the numbers of "eligible" patients. Second, as both treatments were considered equally successful, recruiters and patients focused on the pragmatics of the different trial arms, favouring surgery over radiotherapy. The lack of equipoise was reflected in the way recruiters presented trial information. Third, patient views, beliefs and preferences were not fully elicited or addressed by recruiters. Fourth, in some centres, logistical issues made trial participation difficult. This qualitative research identified several major issues that explained recruitment difficulties. While there was insufficient time to address these in the EaStER trial, several factors would need to be addressed to launch further RCTs in head and neck cancer. These include the need for clear ongoing agreement among recruiting clinicians regarding details in the study protocol; an understanding of the logistical issues hindering recruitment at individual centres; and training recruiters to enable them to explain the need for randomisation and the rationale for the RCT to patients.

Effectiveness of integrated care model for type 2 diabetes: A population-based study in Reggio Emilia (Italy)

PubMed Central

Ballotari, Paola; Manicardi, Valeria; Ferrari, Francesca; Vicentini, Massimo; Greci, Marina; Pignatti, Fabio; Storani, Simone; Giorgi Rossi, Paolo

2018-01-01

Aims To compare the effectiveness of integrated care with that of the diabetes clinic care model in terms of mortality and hospitalisation of type 2 diabetes patients with low risk of complications. Methods Out of 27234 people with type 2 diabetes residing in the province of Reggio Emilia on 31/12/2011, 3071 were included in this cohort study as eligible for integrated care (i.e., low risk of complications) and cared for with the same care model for at least two years. These patients were followed up from 2012 to 2016, for all-cause and diabetes-related mortality and hospital admissions. We performed a Poisson regression model, using the proportion of eligible patients included in the integrated care model for each general practitioner as an instrumental variable. Results 1700 patients were cared for by integrated care and 1371 by diabetes clinics. Mortality rate ratios were 0.83 (95%CI 0.60–1.13) and 0.95 (95%CI 0.54–1.70) for all-cause and cardiovascular mortality, respectively, and incidence rate ratios were 0.90 (95%CI 0.76–1.06) and 0.91 (95%CI 0.69–1.20) for all-cause and cardiovascular disease hospitalisation, respectively. Conclusion For low risk patients with type 2 diabetes, the integrated care model involving both general practitioner and diabetes clinic professionals showed similar mortality and hospitalisation as a model with higher use of specialized care in an exclusively diabetes clinic setting. PMID:29584749

Assessing Colorectal Cancer Screening Behaviors and Knowledge among At-Risk Hispanics in Southern New Mexico*

PubMed Central

Sanchez, Janeth I.; Palacios, Rebecca; Thompson, Beti; Martinez, Vanessa; O’Connell, Mary A.

2014-01-01

Purpose Colorectal cancer (CRC) mortality rates in New Mexico (NM) continue to be higher than national rates. Hispanic CRC mortality rates in NM surpass those of overall Hispanics in the US. This study was designed to characterize and understand factors contributing to low CRC screening rates in this border region. Methods A CRC Knowledge Assessment Survey (KAS) was administered in either English or Spanish to 247 individuals attending community events throughout southern NM. A subset of these individuals completed an online CRC risk assessment survey managed by the National Cancer Institute (NCI). Data analysis tested for significant differences in knowledge, physician-patient CRC interactions, CRC risk level perception, and screening rates across diverse ethnic and age groups. Results Both CRC knowledge and physician-patient CRC interactions were positively associated with participant screening history. Significant age and ethnic differences for CRC knowledge, physician-patient CRC interactions, and screening history in the NM border sample were also seen. Age-eligible Hispanics (50+) as well as those less than 50 years of age had lower CRC knowledge and were less likely to engage in physician-patient CRC interactions than non-Hispanic Whites (NHWs). The age-eligible Hispanics also reported lower CRC screening rates than their NHW counterparts. Conclusions Low CRC knowledge and limited physician-patient CRC interactions appear to contribute to low screening rates in this NM population. Expanding education and outreach efforts for this border population are essential to promote early CRC detection and thereby decrease overall CRC mortality rates. PMID:25621179

Palliative Short-Course Radiation Therapy in Rectal Cancer: A Phase 2 Study

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

Picardi, Vincenzo; Deodato, Francesco; Guido, Alessandra

2016-07-15

Purpose: The management of patients with symptomatic rectal cancer not amenable to curative treatment may be challenging. The aim of this phase 2 study was to evaluate the efficacy of short-course radiation therapy in patients with obstructing rectal cancer. Methods and Materials: Patients who were not candidates for surgical resection because of synchronous metastases, age, and/or comorbidities were considered eligible. The sample size was calculated based on the 2-stage design of Simon. Short-course radiation therapy was delivered with an isocentric 4-field box technique (total, 25 Gy; 5 fractions in 5 days). Chemotherapy was suspended during radiation treatment. Clinical outcome measures were symptomaticmore » response rate, toxicity, colostomy-free survival, and overall survival. Results: From October 2003 to November 2012, 18 patients (median age, 77.5 years) were enrolled. The median follow-up was 11.5 months (range, 3-36 months). Four weeks after treatment, a complete response (ie, complete symptom resolution) was observed in 38.9% of patients and a partial response in 50.0% cases, whereas 11.1% had no response. The rates of reduction or resolution of pain and bleeding were 87.5% and 100%, respectively. The 1-, 2-, and 3-year colostomy-free survival rates were 100%, 71.4%, and 47.6%, respectively (median, 30 months). The 1-, 2-, and 3-year cumulative overall survival rates were 85.2%, 53%, and 39.8%, respectively (median, 25 months). No patients stopped treatment because of gastrointestinal or genitourinary toxicities: 38.9% of patients had grade 1 to 2 toxicity, and 16.7% had grade 3 toxicity. Only 1 patient had hematologic grade 2 toxicity, and 2 patients had grade 2 skin toxicity. Conclusions: Short-course radiation therapy may represent a safe and effective alternative treatment option in patients with obstructing rectal cancer not eligible for curative treatment, allowing colostomy to be avoided in a substantial proportion of patients.« less

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

A Multi-institutional Study of Factors Influencing the Use of Stereotactic Radiosurgery for Brain Metastases

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

Hodgson, David C., E-mail: David.Hodgson@rmp.uhn.on.ca; Department of Radiation Oncology, University of Toronto, Toronto, Ontario; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario

2013-02-01

Purpose: Stereotactic radiosurgery (SRS) for brain metastases is a relatively well-studied technology with established guidelines regarding patient selection, although its implementation is technically complex. We evaluated the extent to which local availability of SRS affected the treatment of patients with brain metastases. Methods and Materials: We identified 3030 patients who received whole-brain radiation therapy (WBRT) for brain metastases in 1 of 7 cancer centers in Ontario. Clinical data were abstracted for a random sample of 973 patients. Logistic regression analyses were performed to identify factors associated with the use of SRS as a boost within 4 months following WBRT ormore » at any time following WBRT. Results: Of 898 patients eligible for analysis, SRS was provided to 70 (7.8%) patients at some time during the course of their disease and to 34 (3.8%) patients as a boost following WBRT. In multivariable analyses, factors significantly associated with the use of SRS boost following WBRT were fewer brain metastases (odds ratio [OR] = 6.50), controlled extracranial disease (OR = 3.49), age (OR = 0.97 per year of advancing age), and the presence of an on-site SRS program at the hospital where WBRT was given (OR = 12.34; all P values were <.05). Similarly, availability of on-site SRS was the factor most predictive of the use of SRS at any time following WBRT (OR = 5.98). Among patients with 1-3 brain metastases, good/fair performance status, and no evidence of active extracranial disease, SRS was provided to 40.3% of patients who received WBRT in a hospital that had an on-site SRS program vs 3.0% of patients who received WBRT at a hospital without SRS (P<.01). Conclusions: The availability of on-site SRS is the factor most strongly associated with the provision of this treatment to patients with brain metastases and appears to be more influential than accepted clinical eligibility factors.« less

Mutational Landscape of cfDNA Identifies Distinct Molecular Features Associated With Therapeutic Response to First-Line Platinum-Based Doublet Chemotherapy in Patients with Advanced NSCLC

PubMed Central

Jiang, Tao; Li, Xuefei; Wang, Jianfei; Su, Chunxia; Han, Wenbo; Zhao, Chao; Wu, Fengying; Gao, Guanghui; Li, Wei; Chen, Xiaoxia; Li, Jiayu; Zhou, Fei; Zhao, Jing; Cai, Weijing; Zhang, Henghui; Du, Bo; Zhang, Jun; Ren, Shengxiang; Zhou, Caicun; Yu, Hui; Hirsch, Fred R.

2017-01-01

Rationale To investigate whether the mutational landscape of circulating cell-free DNA (cfDNA) could predict and dynamically monitor the response to first-line platinum-based chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC). Methods Eligible patients were included and blood samples were collected from a phase III trial. Both cfDNA fragments and fragmented genomic DNA were extracted for enrichment in a 1.15M size panel covering exon regions of 1,086 genes. Molecular mutational burden (MMB) was calculated to investigate the relationship between molecular features of cfDNA and response to chemotherapy. Results In total, 52 eligible cases were enrolled and their blood samples were prospectively collected at baseline, every cycle of chemotherapy and time of disease progression. At baseline, alterations of 17 genes were found. Patients with partial response (PR) had significantly lower baseline MMB of these genes than those patients with either stable disease (SD) (P = 0.0006) or progression disease (PD) (P = 0.0074). Further analysis revealed that the mutational landscape of cfDNA from pretreatment blood samples were distinctly different among patients with PR vs. SD/PD. For patients with baseline TP53 mutation, those with PR experienced a significant reduction in MMB whereas patients with SD or PD experienced an increase after two, three or four cycles of chemotherapy. Furthermore, patients with low MMB had superior response rate and significantly longer progression-free survival than those with high MMB. Conclusion This study indicated that the mutational landscape of cfDNA has potential clinical value to predict the therapeutic response to first-line platinum-based doublet chemotherapy in NSCLC patients. At the single gene level, dynamic change of molecular mutational burden of TP53 is valuable to monitor efficacy (and, therefore, might aid in early recognition of resistance and relapse) in patients harboring this mutation at baseline. PMID:29187901

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.

Helping Clinicians Prevent Pregnancy among Sexually Active Adolescents: U.S. Medical Eligibility Criteria for Contraceptive Use and U.S. Selected Practice Recommendations for Contraceptive Use.

PubMed

Godfrey, Emily M

2015-08-01

The United States has made substantial progress in reducing teenage birth rates in recent decades, but rates remain high. Teen pregnancy can increase the risk of poor health outcomes and lead to decreased educational attainment, increased poverty, and welfare use, as well as increased cost to taxpayers. One of the most effective ways to prevent teenage pregnancy is through the use of effective birth control methods. The Centers for Disease Control (CDC) and Prevention has made the prevention of teenage pregnancy 1 of its 10 winnable battles. The CDC has released 2 evidence-based clinical guideline documents regarding contraceptive use for adolescents and adults. The first guideline, US Medical Eligibility Criteria for Contraceptive Use, 2010, helps clinicians recognize when a contraceptive method may not be safe to use for a particular adolescent but also when not to withhold a contraceptive method that is safe to use. The second document, US Selected Practice Recommendations for Contraceptive Use, 2013, provides guidance for how to use contraceptive methods safely and effectively once they are deemed safe. Health care providers are encouraged to use these documents to provide safe and effective contraceptive care to patients seeking family planning, including adolescents. Copyright © 2015 North American Society for Pediatric and Adolescent Gynecology. All rights reserved.

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.

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.

Systemic impairment in relation to disease burden in patients with moderate COPD eligible for a lifestyle program. Findings from the INTERCOM trial

PubMed Central

van Wetering, Carel R; van Nooten, Floortje E; Mol, Stijn J M; Hoogendoorn, Martine; Rutten-van Mölken, Maureen P M H; Schols, Annemie M

2008-01-01

Introduction In contrast with the frequency distribution of chronic obstructive pulmonary disease (COPD) stages in the population, in which the majority of the patients is classified as GOLD 2, much less information is available on the prevalence and implications of systemic manifestations in less severe patients relative to GOLD 3 and 4. Aim To characterize local and systemic impairment in relation to disease burden in a group of GOLD 2 COPD patients (n = 127, forced expiratory volume in one second (SD): 67 (11)% pred) that were eligible for the Interdisciplinary Community-based COPD management (INTERCOM) trial. Methods Patients were included for this lifestyle program based on a peak exercise capacity (Wmax) <70% of predicted. Metabolic and ventilatory response to incremental cycle ergometry, 6 minute walking distance (6MWD), constant work rate test (CWR), lung function, maximal inspiratory pressure (Pimax), quadriceps force (QF), quadriceps average power (QP) (isokinetic dynamometry), handgrip force (HGF) and body composition were measured. Quality of life (QoL) was assessed by the St. George’s Respiratory Questionnaire (SGRQ) and dyspnea by the modified Medical Research Council (MRC) dyspnea scale. Exacerbations and COPD-associated hospital admissions in 12 months prior to the start of the study were recorded. Burden of disease was defined in terms of exercise capacity, QoL, hospitalization, and exacerbation frequency. GOLD 2 patients were compared with reference values and with GOLD 3 patients who were also included in the trial. Results HGF (77.7 (18.8) % pred) and Pimax (67.1 (22.5)% pred) were impaired in GOLD 2, while QF (93.5 (22.5)% pred) was only modestly decreased. Depletion of FFM was present in 15% of weight stable GOLD 2 patients while only 2% had experienced recent involuntary weight loss. In contrast to Wmax, submaximal exercise capacity, muscle function, and body composition were not significantly different between GOLD 2 and 3 subgroups. Body mass index and fat-free mass index were significantly lower in smokers compared to ex-smokers. In multivariate analysis, QF and diffusing capacity (DLco) were independently associated with Wmax and 6 MWD in GOLD 2 while only 6 MWD was identified as an independent determinant of health-related QoL. HGF was an independent predictor of hospitalization. Conclusions This study shows that also in patients with moderate COPD, eligible for a lifestyle program based on a decreased exercise capacity, systemic impairment is an important determinant of disease burden and that smoking affects body composition. PMID:18990973

Primary Prevention Implantable Cardioverter-Defibrillators and Survival in Older Women

PubMed Central

Zeitler, Emily P.; Hellkamp, Anne S.; Fonarow, Gregg C.; Hammill, Stephen C.; Curtis, Lesley H.; Hernandez, Adrian F.; Al-Khalidi, Hussein R.; Curtis, Jeptha P.; Heidenreich, Paul A.; Anstrom, Kevin J.; Peterson, Eric D.; Mark, Daniel B.; Hammill, Bradley G.; Sanders, Gillian D.; Al-Khatib, Sana M.

2015-01-01

OBJECTIVES The purpose of this study was to assess the benefit of primary prevention implantable cardioverter defibrillators (ICDs) in women. BACKGROUND Clinical trials of primary prevention ICDs enrolled a limited number of women. METHODS Using a propensity score method, we matched 490 women ≥65 years of age who received an ICD during a hospitalization for heart failure in the National Cardiovascular Data Registry ICD Registry from January 1, 2006, through December 31, 2007, to 490 ICD-eligible women without an ICD hospitalized for heart failure in the Get With The Guidelines for Heart Failure database from January 1, 2006, through December 31, 2009. The primary endpoint was all-cause mortality obtained from the Medicare Claims Database. An identical analysis was conducted in men. RESULTS Median follow-up for patients with an ICD was 4.6 years versus 3.2 years for patients with no ICD. Compared with women with no ICD, those with an ICD were younger and less frequently white. In the matched cohorts, the survival of women with an ICD was significantly longer than that of women without an ICD (adjusted hazard ratio: 0.79, 95% confidence interval: 0.66 to 0.95; p = 0.013). Similarly, men with an ICD had longer survival than men without an ICD (adjusted hazard ratio: 0.73, 95% confidence interval: 0.65 to 0.83; p < 0.0001). There was no interaction between sex and the presence of an ICD with respect to survival (p = 0.44). CONCLUSIONS Among older women with left ventricular dysfunction, a primary prevention ICD was associated with a significant survival benefit that was nearly identical to that seen in men. These findings support the use of primary prevention ICDs in eligible patients regardless of sex. PMID:25543969

Patients’ perspectives on the medical primary–secondary care interface: systematic review and synthesis of qualitative research

PubMed Central

Sampson, Rod; Cooper, Jamie; Barbour, Rosaline; Polson, Rob; Wilson, Philip

2015-01-01

Objectives To synthesise the published literature on the patient experience of the medical primary–secondary care interface and to determine priorities for future work in this field aimed at improving clinical outcomes. Design Systematic review and metaethnographic synthesis of primary studies that used qualitative methods to explore patients’ perspectives of the medical primary–secondary care interface. Setting International primary–secondary care interface. Data sources EMBASE, MEDLINE, CINAHL Plus with Full text, PsycINFO, Psychology and Behavioural Sciences Collection, Health Business Elite, Biomedica Reference Collection: Comprehensive Library, Information Science & Technology Abstracts, eBook Collection, Web of Science Core Collection: Citation Indexes and Social Sciences Citation Index, and grey literature. Eligibility criteria for selecting studies Studies were eligible for inclusion if they were full research papers employing qualitative methodology to explore patients’ perspectives of the medical primary–secondary care interface. Review methods The 7-step metaethnographic approach described by Noblit and Hare, which involves cross-interpretation between studies while preserving the context of the primary data. Results The search identified 690 articles, of which 39 were selected for full-text review. 20 articles were included in the systematic review that encompassed a total of 689 patients from 10 countries. 4 important areas specific to the primary–secondary care interface from the patients’ perspective emerged: barriers to care, communication, coordination, and ‘relationships and personal value’. Conclusions and implications of key findings Patients should be the focus of any transfer of care between primary and secondary systems. From their perspective, areas for improvement may be classified into four domains that should usefully guide future work aimed at improving quality at this important interface. Trial registration number PROSPERO CRD42014009486. PMID:26474939

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.

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.

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.

Low level laser therapy in the treatment of oral mucositis in cancer patients: systematic review of literature

NASA Astrophysics Data System (ADS)

El-Sabbagh, Rula Fawzi; Selting, Wayne J.

2016-03-01

Oral mucositis is a debilitating and dose limiting side effect of oncotherapy in cancer patients. Low Level Laser Therapy (LLLT) is a promising new intervention for the treatment of oral mucositis. Aims and objectives: 1. Perform a systematic review of available literature on the therapeutic effect of LLLT on established oral mucositis. 2. Formulate recommendations for future studies based on results of review. Methods: Electronic search oflow level laser therapy in the treatment of oral mucositis was conducted and eligible studies reviewed. Results: Four studies met the inclusion criteria and were analyzed. A total of 109 patients were included, 59 of which received LLLT as a therapeutic measure. An overall success rate of 81.4% success rate was reported in regard to OM. Conclusion: The review demonstrated the positive therapeutic effect of LLLT on oral mucositis. However, the need for future studies with standardized reporting of parameters and methods is needed to increase the level of evidence of this intervention.

En-bloc Transplantation: an Eligible Technique for Unilateral Dual Kidney Transplantation

PubMed Central

Salehipour, M.; Bahador, A.; Nikeghbalian, S.; Kazemi, K.; Shamsaeifar, A. R.; Ghaffaripour, S.; Sahmeddini, M. A.; Salahi, H.; Bahreini, A.; Janghorban, P.; Gholami, S.; Malek-Hosseini, S. A.

2012-01-01

Background: Kidney transplantation is the best available treatment for patients with end-stage renal disease. Objective: To evaluate the en bloc anastomosis technique for unilateral dual kidney transplantation (DKT). Methods: From May to October 2011, 5 patients (4 women and 1 man) with mean age of 31.8 years underwent unilateral DKT with this technique in which distal end of the aorta and proximal end of inferior vena cava (IVC) were closed with running sutures. Then, proximal end of the aorta and distal end of the IVC were anastomosed to internal (or external) iliac artery and external iliac vein, respectively. Results: Post-operative course was uneventful. No vascular and urologic complications developed; all patient had acceptable serum creatinine at discharge time and up of 2–6 months of post-operation follow up. Conclusion: Unilateral DKT is a safe method for performing DKT. The proposed en bloc anastomosis can improve the outcome of the graft by reducing the cold ischemia and the operation time. PMID:25013633

Digestive and urologic hemorrhage after intravenous thrombolysis for acute ischemic stroke: Data from a Chinese stroke center.

PubMed

Chang, Hong; Wang, Xiaojuan; Yang, Xin; Song, Haiqing; Qiao, Yuchen; Liu, Jia

2017-02-01

Objective Intravenous thrombolysis with recombinant tissue plasminogen activator (rt-PA) is considered the most effective treatment method for AIS; however, it is associated with a risk of hemorrhage. We analyzed the risk factors for digestive and urologic hemorrhage during rt-PA therapy. Methods We retrospectively analyzed patients with AIS who underwent intravenous thrombolysis with rt-PA during a 5-year period in a Chinese stroke center. Data on the demographics, medical history, laboratory test results, and clinical outcomes were collected. Results 338 patients with AIS were eligible and included. Logistic regression multivariate analysis showed that gastric catheter was significantly correlated with digestive hemorrhage, while age and urinary catheter were significantly correlated with urologic hemorrhage. Most hemorrhagic events were associated with catheterization after 1 to 24 hours of rt-PA therapy. Conclusions In summary, gastric and urinary catheters were correlated with digestive and urologic hemorrhage in patients with AIS undergoing rt-PA therapy. Well-designed controlled studies with large samples are required to confirm our findings.

Psychiatrists' follow-up of identified metabolic risk: a mixed-method analysis of outcomes and influences on practice

PubMed Central

Patterson, Sue; Freshwater, Kathleen; Goulter, Nicole; Ewing, Julie; Leamon, Boyd; Choudhary, Anand; Moudgil, Vikas; Emmerson, Brett

2016-01-01

Aims and method To describe and explain psychiatrists' responses to metabolic abnormalities identified during screening. We carried out an audit of clinical records to assess rates of monitoring and follow-up practice. Semi-structured interviews with 36 psychiatrists followed by descriptive and thematic analyses were conducted. Results Metabolic abnormalities were identified in 76% of eligible patients screened. Follow-up, recorded for 59%, was variable but more likely with four or more abnormalities. Psychiatrists endorse guidelines but ambivalence about responsibility, professional norms, resource constraints and skills deficits as well as patient factors influences practice. Therapeutic optimism and desire to be a ‘good doctor’ supported comprehensive follow-up. Clinical implications Psychiatrists are willing to attend to physical healthcare, and obstacles to recommended practice are surmountable. Psychiatrists seek consensus among stakeholders about responsibilities and a systemic approach addressing the social determinants of health inequities. Understanding patients' expectations is critical to promoting best practice. PMID:27752343

eTACTS: A Method for Dynamically Filtering Clinical Trial Search Results

PubMed Central

Miotto, Riccardo; Jiang, Silis; Weng, Chunhua

2013-01-01

Objective Information overload is a significant problem facing online clinical trial searchers. We present eTACTS, a novel interactive retrieval framework using common eligibility tags to dynamically filter clinical trial search results. Materials and Methods eTACTS mines frequent eligibility tags from free-text clinical trial eligibility criteria and uses these tags for trial indexing. After an initial search, eTACTS presents to the user a tag cloud representing the current results. When the user selects a tag, eTACTS retains only those trials containing that tag in their eligibility criteria and generates a new cloud based on tag frequency and co-occurrences in the remaining trials. The user can then select a new tag or unselect a previous tag. The process iterates until a manageable number of trials is returned. We evaluated eTACTS in terms of filtering efficiency, diversity of the search results, and user eligibility to the filtered trials using both qualitative and quantitative methods. Results eTACTS (1) rapidly reduced search results from over a thousand trials to ten; (2) highlighted trials that are generally not top-ranked by conventional search engines; and (3) retrieved a greater number of suitable trials than existing search engines. Discussion eTACTS enables intuitive clinical trial searches by indexing eligibility criteria with effective tags. User evaluation was limited to one case study and a small group of evaluators due to the long duration of the experiment. Although a larger-scale evaluation could be conducted, this feasibility study demonstrated significant advantages of eTACTS over existing clinical trial search engines. Conclusion A dynamic eligibility tag cloud can potentially enhance state-of-the-art clinical trial search engines by allowing intuitive and efficient filtering of the search result space. PMID:23916863

Strategies to support recruitment of patients with life-limiting illness for research: the Palliative Care Research Cooperative Group.

PubMed

Hanson, Laura C; Bull, Janet; Wessell, Kathryn; Massie, Lisa; Bennett, Rachael E; Kutner, Jean S; Aziz, Noreen M; Abernethy, Amy

2014-12-01

The Palliative Care Research Cooperative Group (PCRC) is the first clinical trials cooperative for palliative care in the U.S. To describe barriers and strategies for recruitment during the inaugural PCRC clinical trial. The parent study was a multisite randomized controlled trial enrolling adults with life expectancy anticipated to be one to six months, randomized to discontinue statins (intervention) vs. to continue on statins (control). To study recruitment best practices, we conducted semistructured interviews with 18 site principal investigators (PIs) and clinical research coordinators (CRCs) and reviewed recruitment rates. Interviews covered three topics: 1) successful strategies for recruitment, 2) barriers to recruitment, and 3) optimal roles of the PI and CRC. All eligible site PIs and CRCs completed interviews and provided data on statin protocol recruitment. The parent study completed recruitment of 381 patients. Site enrollment ranged from 1 to 109 participants, with an average of 25 enrolled per site. Five major barriers included difficulty locating eligible patients, severity of illness, family and provider protectiveness, seeking patients in multiple settings, and lack of resources for recruitment activities. Five effective recruitment strategies included systematic screening of patient lists, thoughtful messaging to make research relevant, flexible protocols to accommodate patients' needs, support from clinical champions, and the additional resources of a trials cooperative group. The recruitment experience from the multisite PCRC yields new insights into methods for effective recruitment to palliative care clinical trials. These results will inform training materials for the PCRC and may assist other investigators in the field. Copyright © 2014 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

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

A Phase I trial using local regional treatment, nonlethal irradiation, intratumoral and systemic polyinosinic-polycytidylic acid polylysine carboxymethylcellulose to treat liver cancer: in search of the abscopal effect

PubMed Central

de la Torre, Andrew N; Contractor, Sohail; Castaneda, Ismael; Cathcart, Charles S; Razdan, Dolly; Klyde, David; Kisza, Piotr; Gonzales, Sharon F; Salazar, Andres M

2017-01-01

Purpose To determine the safety of an approach to immunologically enhance local treatment of hepatocellular cancer (HCC) by combining nonlethal radiation, local regional therapy with intratumoral injection, and systemic administration of a potent Toll-like receptor (TLR) immune adjuvant. Methods Patients with HCC not eligible for liver transplant or surgery were subject to: 1) 3 fractions of 2-Gy focal nonlethal radiation to increase tumor antigen expression, 2) intra-/peri-tumoral (IT) injection of the TLR3 agonist, polyinosinic-polycytidylic acid polylysine carboxymethylcellulose (poly-ICLC), to induce an immunologic “danger” response in the tumor microenvironment with local regional therapy, and 3) systemic boosting of immunity with intramuscular poly-ICLC. Primary end points were safety and tolerability; secondary end points were progression-free survival (PFS) and overall survival (OS) at 6 months, 1 year, and 2 years. Results Eighteen patients with HCC not eligible for surgery or liver transplant were treated. Aside from 1 embolization-related severe adverse event, all events were ≤grade II. PFS was 66% at 6 months, 39% at 12 months, and 28% at 24 months. Overall 1-year survival was 69%, and 2-year survival 38%. In patients <60 years old, 2-year survival was 62.5% vs. 11.1% in patients aged >60 years (P<0.05). Several patients had prolonged PFS and OS. Conclusion Intra-tumoral injection of the TLR3 agonist poly-ICLC in patients with HCC is safe and tolerable when combined with local nonlethal radiation and local regional treatment. Further work is in progress to evaluate if this approach improves survival compared to local regional treatment alone and characterize changes in anticancer immunity. PMID:28848723

Randomized controlled trial comparing telephone and mail follow-up for recruitment of participants into a clinical trial of colorectal cancer screening.

PubMed

Wong, Arthur D; Kirby, John; Guyatt, Gordon H; Moayyedi, Paul; Vora, Parag; You, John J

2013-02-11

Investigators often face challenges when recruiting participants into randomized controlled trials (RCTs). Some data suggest that telephone reminders may lead to greater participant enrollment. Patients aged 50 to 70 years from family practice rosters were initially mailed invitations to participate in an RCT of colorectal cancer screening. Patients who did not respond were randomly allocated to follow-up invitations by either telephone or mail four weeks after the initial invitation. The primary outcome was attendance for eligibility screening with the study nurse. After mailing invitations to 1,348 patients, 104 patients were initially enrolled in the RCT of colon cancer screening. Of 952 patients who did not respond to the initial mailed invitation, we randomly allocated 480 to follow-up invitation by telephone and 472 to follow-up invitation by mail. Attendance for eligibility screening with the study nurse was more frequent when non-responders were followed-up by telephone (84/480, 17.5%) than by mail (43/472, 9.1%) (relative risk (RR) 1.92, 95% confidence interval (CI) 1.36 to 2.71, P < 0.001). Enrollment into the RCT was also greater among patients followed-up by telephone (59/480, 12.3%) compared to those followed-up by mail (35/472, 7.4%) (RR 1.66, 95% CI 1.11 to 2.47, P=0.01). Telephone-based follow-up results in greater enrollment compared to a mail-based method. Our findings should be of interest to investigators conducting RCTs, particularly trials of screening interventions involving asymptomatic participants for which volunteer participation may be challenging. Clinicaltrials.gov NCT00865527.

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.

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.

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.

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.

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.

Topotecan-Vincristine-Doxorubicin in Stage 4 High-Risk Neuroblastoma Patients Failing to Achieve a Complete Metastatic Response to Rapid COJEC: A SIOPEN Study

PubMed Central

Amoroso, Loredana; Erminio, Giovanni; Makin, Guy; Pearson, Andrew D. J.; Brock, Penelope; Valteau-Couanet, Dominique; Castel, Victoria; Pasquet, Marlène; Laureys, Genevieve; Thomas, Caroline; Luksch, Roberto; Ladenstein, Ruth; Haupt, Riccardo; Garaventa, Alberto

2018-01-01

Purpose Metastatic response to induction therapy for high-risk neuroblastoma is a prognostic factor. In the International Society of Paediatric Oncology Europe Neuroblastoma (SIOPEN) HR-NBL-1 protocol, only patients with metastatic complete response (CR) or partial response (PR) with ≤ three abnormal skeletal areas on iodine 123-metaiodobenzylguanidine ([123I]mIBG) scintigraphy and no bone marrow disease proceed to high dose therapy (HDT). In this study, topotecan-vincristine-doxorubicin (TVD) was evaluated in patients failing to achieve these criteria, with the aim of improving the metastatic response rate. Materials and Methods Patients with metastatic high-risk neuroblastoma who had not achieved the SIOPEN criteria for HDT after induction received two courses of topotecan 1.5 mg/m2/day for 5 days, followed by a 48-hour infusion of vincristine, 2 mg/m2, and doxorubicin, 45 mg/m2. Results Sixty-three patients were eligible and evaluable. Following two courses of TVD, four (6.4%) patients had an overall CR, while 28 (44.4%) had a PR with a combined response rate of 50.8% (95% confidence interval [CI], 37.9 to 63.6). Of these, 23 patients achieved a metastatic CR or a PR with ≤ 3 mIBG skeletal areas and no bone marrow disease (36.5%; 95% CI, 24.7 to 49.6) and were eligible to receive HDT. Toxicity was mostly haematological, affecting 106 of the 126 courses (84.1%; 95% CI, 76.5 to 90.0), and dose reduction was necessary in six patients. Stomatitis was the second most common nonhematological toxicity, occurring in 20 patients (31.7%). Conclusion TVD was effective in improving the response rate of high-risk neuroblastoma patients after induction with COJEC enabling them to proceed to HDT. However, the long-term benefits of TVD needs to be determined in randomized clinical trials. PMID:28324923

Phase I Study of Concurrent High-Dose Three-Dimensional Conformal Radiotherapy With Chemotherapy Using Cisplatin and Vinorelbine for Unresectable Stage III Non-Small-Cell Lung Cancer

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

Sekine, Ikuo, E-mail: isekine@ncc.go.jp; Sumi, Minako; Ito, Yoshinori

Purpose: To determine the maximum tolerated dose in concurrent three-dimensional conformal radiotherapy (3D-CRT) with chemotherapy for unresectable Stage III non-small-cell lung cancer (NSCLC). Patients and Methods: Eligible patients with unresectable Stage III NSCLC, age {>=}20 years, performance status 0-1, percent of volume of normal lung receiving 20 GY or more (V{sub 20}) {<=}30% received three to four cycles of cisplatin (80 mg/m{sup 2} Day 1) and vinorelbine (20 mg/m{sup 2} Days 1 and 8) repeated every 4 weeks. The doses of 3D-CRT were 66 Gy, 72 Gy, and 78 Gy at dose levels 1 to 3, respectively. Results: Of themore » 17, 16, and 24 patients assessed for eligibility, 13 (76%), 12 (75%), and 6 (25%) were enrolled at dose levels 1 to 3, respectively. The main reasons for exclusion were V{sub 20} >30% (n = 10) and overdose to the esophagus (n = 8) and brachial plexus (n = 2). There were 26 men and 5 women, with a median age of 60 years (range, 41-75). The full planned dose of radiotherapy could be administered to all the patients. Grade 3-4 neutropenia and febrile neutropenia were noted in 24 (77%) and 5 (16%) of the 31 patients, respectively. Grade 4 infection, Grade 3 esophagitis, and Grade 3 pulmonary toxicity were noted in 1 patient, 2 patients, and 1 patient, respectively. The dose-limiting toxicity was noted in 17% of the patients at each dose level. The median survival and 3-year and 4-year survival rates were 41.9 months, 72.3%, and 49.2%, respectively. Conclusions: 72 Gy was the maximum dose that could be achieved in most patients, given the predetermined normal tissue constraints.« less

Clinical applications of cell-based approaches in alveolar bone augmentation: a systematic review.

PubMed

Shanbhag, Siddharth; Shanbhag, Vivek

2015-01-01

Cell-based approaches, utilizing adult mesenchymal stem cells (MSCs), are reported to overcome the limitations of conventional bone augmentation procedures. The study aims to systematically review the available evidence on the characteristics and clinical effectiveness of cell-based ridge augmentation, socket preservation, and sinus-floor augmentation, compared to current evidence-based methods in human adult patients. MEDLINE, EMBASE, and CENTRAL databases were searched for related literature. Both observational and experimental studies reporting outcomes of "tissue engineered" or "cell-based" augmentation in ≥5 adult patients alone, or in comparison with non-cell-based (conventional) augmentation methods, were eligible for inclusion. Primary outcome was histomorphometric analysis of new bone formation. Effectiveness of cell-based augmentation was evaluated based on outcomes of controlled studies. Twenty-seven eligible studies were identified. Of these, 15 included a control group (8 randomized controlled trials [RCTs]), and were judged to be at a moderate-to-high risk of bias. Most studies reported the combined use of cultured autologous MSCs with an osteoconductive bone substitute (BS) scaffold. Iliac bone marrow and mandibular periosteum were frequently reported sources of MSCs. In vitro culture of MSCs took between 12 days and 1.5 months. A range of autogenous, allogeneic, xenogeneic, and alloplastic scaffolds was identified. Bovine bone mineral scaffold was frequently reported with favorable outcomes, while polylactic-polyglycolic acid copolymer (PLGA) scaffold resulted in graft failure in three studies. The combination of MSCs and BS resulted in outcomes similar to autogenous bone (AB) and BS. Three RCTs and one controlled trial reported significantly greater bone formation in cell-based than conventionally grafted sites after 3 to 8 months. Based on limited controlled evidence at a moderate-to-high risk of bias, cell-based approaches are comparable, if not superior, to current evidence-based bone grafting methods, with a significant advantage of avoiding AB harvesting. Future clinical trials should additionally evaluate patient-based outcomes and the time-/cost-effectiveness of these approaches. © 2013 Wiley Periodicals, Inc.

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.

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.

Next-generation sequencing facilitates detection of the classic E13-A20 EML4-ALK fusion in an ALK-FISH/IHC inconclusive biopsy of a stage IV lung cancer patient: a case report.

PubMed

Volckmar, Anna-Lena; Endris, Volker; Bozorgmehr, Farastuk; Lier, Clemens; Porcel, Carlota; Kirchner, Martina; Leichsenring, Jonas; Penzel, Roland; Thomas, Michael; Schirmacher, Peter; Warth, Arne; Stenzinger, Albrecht

2016-11-18

Inhibition of the oncogenic fusion-gene EML4-ALK is a current first-line approach for patients with stage IV non-small cell lung cancer. While FISH was established as the gold standard for identifying these patients, there is accumulating evidence that other methods of detection, i.e., immunohistochemistry and next-generation sequencing (NGS), exist that may be equally successful. However, the concordance of these methods is under investigation. Adding to the current literature, we here report a 56 year old female never-smoker with stage IV lung adenocarcinoma whose biopsy was IHC and FISH inconclusive but positive in NGS. Retroactive profiling of the resection specimen corroborated fusion reads obtained by NGS, FISH-positivity and showed weak ALK-positivity by IHC. Consequently, we diagnosed the case as ALK-positive rendering the patient eligible to crizotinib treatment. With IHC on biopsy material only, this case would have been overlooked withholding effective therapy.

Decreased Management of Genital Warts in Young Women in Australian General Practice Post Introduction of National HPV Vaccination Program: Results from a Nationally Representative Cross-Sectional General Practice Study

PubMed Central

Harrison, Christopher; Britt, Helena; Garland, Suzanne; Conway, Lynne; Stein, Alicia; Pirotta, Marie; Fairley, Christopher

2014-01-01

Objectives Since the introduction of Australia's human papillomavirus vaccination program, the management rate of genital warts in sexual health clinics and private hospitals has decreased in women of vaccine-eligible age. However, most genital warts in Australia are managed in general practice. This study examines whether a similar decrease occurred in Australian general practice after the introduction of the program. Methods Analysis of a nationally representative cross-sectional database of Australian general practice activity (1,175,879 patient encounters with 11,780 general practitioners). Genital warts management rates were estimated for the periods before and after introduction of the program (Pre-program, July 2002-June 2006; Post-program, July 2008-June 2012). Control conditions included genital herpes and gardnerella/bacterial vaginosis in female patients and genital herpes and urethritis in male patients. Trends in management rates by year, pre-vaccine (July 2000-June 2007) and post-vaccine (July 2007-June 2012) were also calculated. Results Management rate of genital warts among women potentially covered by program (aged 15–27 years) decreased by 61% from 4.33 per 1,000 encounters in the Pre-program period to 1.67 in the Post-program period. Trend analysis of the post-vaccine period showed, among women of vaccine eligible age, a significant year-on-year reduction in the rate of genital warts management (p<0.0001) and a significant increase in the management rate of control conditions per year (p<0.0001). For all other age-sex groups there was no significant change in the management rate of genital warts between the Pre- and Post-program periods. Conclusion The large decrease in general practice management of genital warts in women of vaccine-eligible age highlights the success of the program in the wider community. PMID:25180698

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.

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.

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

How does feedback from patients impact upon healthcare student clinical skill development and learning? A systematic review.

PubMed

Finch, Emma; Lethlean, Jennifer; Rose, Tanya; Fleming, Jennifer; Theodoros, Deborah; Cameron, Ashley; Coleman, Adele; Copland, David; McPhail, Steven M

2018-03-01

A key feature of health professionals' training, irrespective of discipline, is the acquisition and application of clinical and communication skills. Despite this, little is known about the potential role of patient feedback on this process. This systematic review aimed to answer the question: How does feedback from patients impact upon healthcare student clinical skill development and learning? Systematic review of published literature. Electronic databases were searched for studies that explored the effects of patient feedback on student learning and were published before March 2016. Eligible articles underwent methodological evaluation using the McMaster University Critical Evaluation Forms and data extraction. A total of 237 articles were retrieved following searches of electronic databases and hand searches of reference lists. Twelve (7 quantitative, 2 qualitative, 3 mixed methods) studies met the inclusion criteria. Eleven studies reported that patient feedback improved students' clinical skills. Minimal research has explored the impact of patient feedback on student learning. The research to date suggests that direct feedback from patients may be beneficial for the development of students' communication and clinical skills; however, the wide variety of evaluation methods and the lack of validated tools for patients to provide feedback suggest that further exploration is warranted.

A clinically guided approach for improving performance measurement for hypertension.

PubMed

Steinman, Michael A; Lee, Sei J; Peterson, Carolyn A; Fung, Kathy Z; Goldstein, Mary K

2012-05-01

Performance measures often fail to account for legitimate reasons why patients do not achieve recommended treatment targets. We tested a novel performance measurement system for blood pressure (BP) control that was designed to mimic clinical reasoning. This clinically guided approach focuses on (1) exempting patients for whom tight BP control may not be appropriate or feasible and (2) assessing BP over time. Trained abstractors conducted structured chart reviews of 201 adults with hypertension in 2 VA health care systems. Results were compared with traditional methods of performance measurement. Among 201 veterans, 183 (91%) were male, and the mean age was 71±11 years. Using the clinically guided approach, 61 patients (30%) were exempted from performance measurement. The most common reasons for exemption were inadequate opportunity to manage BP (35 patients, 17%) and the use of 4 or more antihypertensive medications (19 patients, 9%). Among patients eligible for performance measurement, there was little agreement on the presence of controlled versus uncontrolled BP when comparing the most recent BP (the traditional approach) with an integrated assessment of BP control (κ 0.14). After accounting for clinically guided exemptions and methods of BP assessment, only 15 of 72 patients (21%) whose last BP was ≥140/90 mm Hg were classified as problematic by the clinically guided approach. Many patients have legitimate reasons for not achieving tight BP control, and the methods used for BP assessment have marked effects on whether a patient is classified as having adequate or inadequate BP control.

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.

Trends in use of medical abortion in the United States: reanalysis of surveillance data from the Centers for Disease Control and Prevention, 2001-2008.

PubMed

Pazol, Karen; Creanga, Andreea A; Zane, Suzanne B

2012-12-01

With changing patterns and increasing use of medical abortion in the United States, it is important to have accurate statistics on the use of this method regularly available. This study assesses the accuracy of medical abortion data reported annually to the Centers for Disease Control and Prevention (CDC) and describes trends over time in the use of medical abortion relative to other methods. This analysis included data reported to CDC for 2001-2008. Year-specific analyses included all states that monitored medical abortion for a given year, while trend analyses were restricted to states that monitored medical abortion continuously from 2001 to 2008. Data quality and completeness were assessed by (a) examining abortions reported with an unspecified method type within the gestational age limit for medical abortion (med-eligible abortions) and (b) comparing the percentage of all abortions and med-eligible abortions reported to CDC as medical abortions with estimates based on published mifepristone sales data for the United States from 2001 to 2007. During 2001-2008, the percentage of med-eligible abortions reported to CDC with an unspecified method type remained low (1.0%-2.2%); CDC data and mifepristone sales estimates for 2001-2007 demonstrated strong agreement [all abortions: intraclass correlation coefficient (ICC)=0.983; med-eligible abortions: ICC=0.988]. During 2001-2008, the percentage of abortions reported to CDC as medical abortions increased (p<.001 for all abortions and for med-eligible abortions). Among states that reported medical abortions for 2008, 15% of all abortions and 23% of med-eligible abortions were reported as medical abortions. CDC's Abortion Surveillance System provides an important annual data source that accurately describes the use of medical abortion relative to other methods in the United States. Published by Elsevier Inc.

Population impact of the 2017 ACC/AHA guidelines compared with the 2013 ESH/ESC guidelines for hypertension management.

PubMed

Vaucher, Julien; Marques-Vidal, Pedro; Waeber, Gérard; Vollenweider, Peter

2018-01-01

Background The 2017 ACC/AHA guidelines on hypertension management recommend the introduction of antihypertensive treatment for patients with new stage 1 hypertension thresholds (130-139/80-89 mm Hg) and with a cardiovascular disease or related condition. We compared the Swiss population and economic impact of antihypertensive treatment of the 2017 ACC/AHA guidelines with the 2013 European guidelines. Methods Analyses were based on 4438 participants (aged 45-85 years; 2448 women) of the CoLaus|PsyCoLaus study recruited between 2014-2017. Participants eligible for antihypertensive treatment according to the 2017 ACC/AHA and 2013 European guidelines were sex and age standardised using the Swiss population for 2016. In addition, we estimated the population-wide annual costs of antihypertensive treatment. Results Individuals eligible for antihypertensive treatment were 40.3% (95% confidence interval 38.5-42.1) and 31.3% (29.7-32.9) according to the 2017 ACC/AHA and 2013 European guidelines, respectively. That difference would translate into approximately 250,000 additional individuals eligible for antihypertensive treatment, corresponding to an additional annual cost of 72.5 million CHF (63.0 million EUR). Conclusion The 2017 ACC/AHA guidelines on the management of hypertension substantially increase the number of individuals eligible for antihypertensive treatment compared to the 2013 European guidelines. While implementation of the 2017 ACC/AHA guidelines is expected to lead to cost reduction by preventing cardiovascular diseases, that reduction might be mitigated by the costs incurred by antihypertensive treatments in a larger proportion of the population.

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.

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.

Availability of Volunteer-Led Home-Based Care System and Baseline Factors as Predictors of Clinical Outcomes in HIV-Infected Patients in Rural Zambia

PubMed Central

Estopinal, Christopher B.; van Dijk, Janneke H.; Sitali, Stanley; Stewart, Hannah; Davidson, Mario A.; Spurrier, John; Vermund, Sten H.

2012-01-01

Background We assessed the impact of home-based care (HBC) for HIV+ patients, comparing outcomes between two groups of Zambians receiving antiretroviral therapy (ART) who lived in villages with and without HBC teams. Methods We conducted a retrospective cohort study using medical charts from Macha Mission Hospital, a hospital providing HIV care in Zambia's rural Southern Province. Date of birth, date of ART initiation, place of residence, sex, body mass index (BMI), CD4+ cell count, and hemoglobin (Hgb) were abstracted. Logistic regression was used to test our hypothesis that HBC was associated with treatment outcomes. Results Of 655 patients, 523 (80%) were eligible and included in the study. There were 428 patients (82%) with favorable outcomes (alive and on ART) and 95 patients (18%) with unfavorable outcomes (died, lost to follow-up, or stopped treatment). A minority of the 523 eligible patients (n = 84, 16%) lived in villages with HBC available. Living in a village with HBC was not significantly associated with treatment outcomes; 80% of patients in a village with HBC had favorable outcomes, compared to 82% of patients in a village without HBC (P = 0.6 by χ2). In bivariable analysis, lower BMI (P<0.001), low CD4+ cell count (P = 0.02), low Hgb concentration (P = 0.02), and older age at ART initiation (P = 0.047) were associated with unfavorable outcomes. In multivariable analysis, low BMI remained associated with unfavorable outcomes (P<0.001). Conclusions We did not find that living in a village with HBC available was associated with improved treatment outcomes. We speculate that the ART clinic's rigorous treatment preparation before ART initiation and continuous adherence counseling during ART create a motivated group of patients whose outcomes did not improve with additional HBC support. An alternative explanation is that the quality of the HBC program is suboptimal. PMID:23236351

Increased Detection of Lymphatic Vessel Invasion by D2-40 (Podoplanin) in Early Breast Cancer: Possible Influence on Patient Selection for Accelerated Partial Breast Irradiation

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

Debald, Manuel, E-mail: debald@uni-bonn.d; Poelcher, Martin; Flucke, Uta

2010-07-15

Purpose: Several international trials are currently investigating accelerated partial breast irradiation (APBI) for patients with early-stage breast cancer. According to existing guidelines, patients with lymphatic vessel invasion (LVI) do not qualify for APBI. D2-40 (podoplanin) significantly increases the frequency of LVI detection compared with conventional hematoxylin and eosin (HE) staining in early-stage breast cancer. Our purpose was to retrospectively assess the hypothetical change in management from APBI to whole breast radiotherapy with the application of D2-40. Patients and Methods: Immunostaining with D2-40 was performed on 254 invasive breast tumors of 247 patients. The following criteria were used to determine themore » eligibility for APBI: invasive ductal adenocarcinoma of {<=}3 cm, negative axillary node status (N0), and unifocal disease. Of the 247 patients, 74 with available information concerning LVI, as detected by D2-40 immunostaining and routine HE staining, formed our study population. Results: Using D2-40, our results demonstrated a significantly greater detection rate (p = .031) of LVI compared with routine HE staining. LVI was correctly identified by D2-40 (D2-40-positive LVI) in 10 (13.5%) of 74 tumors. On routine HE staining, 4 tumors (5.4%) were classified as HE-positive LVI. Doublestaining of these specimens with D2-40 unmasked false-positive LVI status in 2 (50%) of the 4 tumors. According to the current recommendations for APBI, immunostaining with D2-40 would have changed the clinical management from APBI to whole breast radiotherapy in 8 (10.8%) of 74 patients and from whole breast radiotherapy to APBI in 2 patients (2.7%). Conclusion: These data support the implementation of D2-40 immunostaining in the routine workup to determine a patient's eligibility for APBI.« less

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

Implementation of a consumer-focused eHealth intervention for people with moderate-to-high cardiovascular disease risk: protocol for a mixed-methods process evaluation.

PubMed

Coorey, Genevieve M; Neubeck, Lis; Usherwood, Timothy; Peiris, David; Parker, Sharon; Lau, Annie Y S; Chow, Clara; Panaretto, Kathryn; Harris, Mark; Zwar, Nicholas; Redfern, Julie

2017-01-11

Technology-mediated strategies have potential to engage patients in modifying unhealthy behaviour and improving medication adherence to reduce morbidity and mortality from cardiovascular disease (CVD). Furthermore, electronic tools offer a medium by which consumers can more actively navigate personal healthcare information. Understanding how, why and among whom such strategies have an effect can help determine the requirements for implementing them at a scale. This paper aims to detail a process evaluation that will (1) assess implementation fidelity of a multicomponent eHealth intervention; (2) determine its effective features; (3) explore contextual factors influencing and maintaining user engagement; and (4) describe barriers, facilitators, preferences and acceptability of such interventions. Mixed-methods sequential design to derive, examine, triangulate and report data from multiple sources. Quantitative data from 3 sources will help to inform both sampling and content framework for the qualitative data collection: (1) surveys of patients and general practitioners (GPs); (2) software analytics; (3) programme delivery records. Qualitative data from interviews with patients and GPs, focus groups with patients and field notes taken by intervention delivery staff will be thematically analysed. Concurrent interview data collection and analysis will enable a thematic framework to evolve inductively and inform theory building, consistent with a realistic evaluation perspective. Eligible patients are those at moderate-to-high CVD risk who were randomised to the intervention arm of a randomised controlled trial of an eHealth intervention and are contactable at completion of the follow-up period; eligible GPs are the primary healthcare providers of these patients. Ethics approval has been received from the University of Sydney Human Research Ethics Committee and the Aboriginal Health and Medical Research Council (AH&MRC) of New South Wales. Results will be disseminated via scientific forums including peer-reviewed publications and national and international conferences. ANZCTR 12613000715774. 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/.

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.

Experience With Direct-to-Patient Recruitment for Enrollment Into a Clinical Trial in a Rare Disease: A Web-Based Study.

PubMed

Krischer, Jeffrey; Cronholm, Peter F; Burroughs, Cristina; McAlear, Carol A; Borchin, Renee; Easley, Ebony; Davis, Trocon; Kullman, Joyce; Carette, Simon; Khalidi, Nader; Koening, Curry; Langford, Carol A; Monach, Paul; Moreland, Larry; Pagnoux, Christian; Specks, Ulrich; Sreih, Antoine G; Ytterberg, Steven; Merkel, Peter A

2017-02-28

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. 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. 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). 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. 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. ©Jeffrey Krischer, Peter F Cronholm, Cristina Burroughs, Carol A McAlear, Renee Borchin, Ebony Easley, Trocon Davis, Joyce Kullman, Simon Carette, Nader Khalidi, Curry Koening, Carol A Langford, Paul Monach, Larry Moreland, Christian Pagnoux, Ulrich Specks, Antoine G Sreih, Steven Ytterberg, Peter A Merkel, Vasculitis Clinical Research Consortium. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 28.02.2017.

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.).

Classification of patients with low back-related leg pain: a systematic review.

PubMed

Stynes, Siobhán; Konstantinou, Kika; Dunn, Kate M

2016-05-23

The identification of clinically relevant subgroups of low back pain (LBP) is considered the number one LBP research priority in primary care. One subgroup of LBP patients are those with back related leg pain. Leg pain frequently accompanies LBP and is associated with increased levels of disability and higher health costs than simple low back pain. Distinguishing between different types of low back-related leg pain (LBLP) is important for clinical management and research applications, but there is currently no clear agreement on how to define and identify LBLP due to nerve root involvement. The aim of this systematic review was to identify, describe and appraise papers that classify or subgroup populations with LBLP, and summarise how leg pain due to nerve root involvement is described and diagnosed in the various systems. The search strategy involved nine electronic databases including Medline and Embase, reference lists of eligible studies and relevant reviews. Selected papers were appraised independently by two reviewers using a standardised scoring tool. Of 13,358 initial potential eligible citations, 50 relevant papers were identified that reported on 22 classification systems. Papers were grouped according to purpose and criteria of the classification systems. Five themes emerged: (i) clinical features (ii) pathoanatomy (iii) treatment-based approach (iv) screening tools and prediction rules and (v) pain mechanisms. Three of the twenty two systems focused specifically on LBLP populations. Systems that scored highest following quality appraisal were ones where authors generally included statistical methods to develop their classifications, and supporting work had been published on the systems' validity, reliability and generalisability. There was lack of consistency in how LBLP due to nerve root involvement was described and diagnosed within the systems. Numerous classification systems exist that include patients with leg pain, a minority of them focus specifically on distinguishing between different presentations of leg pain. Further work is needed to identify clinically meaningful subgroups of LBLP patients, ideally based on large primary care cohort populations and using recommended methods for classification system development.

A Method for Analyzing Commonalities in Clinical Trial Target Populations

PubMed Central

He, Zhe; Carini, Simona; Hao, Tianyong; Sim, Ida; Weng, Chunhua

2014-01-01

ClinicalTrials.gov presents great opportunities for analyzing commonalities in clinical trial target populations to facilitate knowledge reuse when designing eligibility criteria of future trials or to reveal potential systematic biases in selecting population subgroups for clinical research. Towards this goal, this paper presents a novel data resource for enabling such analyses. Our method includes two parts: (1) parsing and indexing eligibility criteria text; and (2) mining common eligibility features and attributes of common numeric features (e.g., A1c). We designed and built a database called “Commonalities in Target Populations of Clinical Trials” (COMPACT), which stores structured eligibility criteria and trial metadata in a readily computable format. We illustrate its use in an example analytic module called CONECT using COMPACT as the backend. Type 2 diabetes is used as an example to analyze commonalities in the target populations of 4,493 clinical trials on this disease. PMID:25954450

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

Design and End Points of Clinical Trials for Patients With Progressive Prostate Cancer and Castrate Levels of Testosterone: Recommendations of the Prostate Cancer Clinical Trials Working Group

PubMed Central

Scher, Howard I.; Halabi, Susan; Tannock, Ian; Morris, Michael; Sternberg, Cora N.; Carducci, Michael A.; Eisenberger, Mario A.; Higano, Celestia; Bubley, Glenn J.; Dreicer, Robert; Petrylak, Daniel; Kantoff, Philip; Basch, Ethan; Kelly, William Kevin; Figg, William D.; Small, Eric J.; Beer, Tomasz M.; Wilding, George; Martin, Alison; Hussain, Maha

2014-01-01

Purpose To update eligibility and outcome measures in trials that evaluate systemic treatment for patients with progressive prostate cancer and castrate levels of testosterone. Methods A committee of investigators experienced in conducting trials for prostate cancer defined new consensus criteria by reviewing previous criteria, Response Evaluation Criteria in Solid Tumors (RECIST), and emerging trial data. Results The Prostate Cancer Clinical Trials Working Group (PCWG2) recommends a two-objective paradigm: (1) controlling, relieving, or eliminating disease manifestations that are present when treatment is initiated and (2) preventing or delaying disease manifestations expected to occur. Prostate cancers progressing despite castrate levels of testosterone are considered castration resistant and not hormone refractory. Eligibility is defined using standard disease assessments to authenticate disease progression, prior treatment, distinct clinical subtypes, and predictive models. Outcomes are reported independently for prostate-specific antigen (PSA), imaging, and clinical measures, avoiding grouped categorizations such as complete or partial response. In most trials, early changes in PSA and/or pain are not acted on without other evidence of disease progression, and treatment should be continued for at least 12 weeks to ensure adequate drug exposure. Bone scans are reported as “new lesions” or “no new lesions,” changes in soft-tissue disease assessed by RECIST, and pain using validated scales. Defining eligibility for prevent/delay end points requires attention to estimated event frequency and/or random assignment to a control group. Conclusion PCWG2 recommends increasing emphasis on time-to-event end points (ie, failure to progress) as decision aids in proceeding from phase II to phase III trials. Recommendations will evolve as data are generated on the utility of intermediate end points to predict clinical benefit. PMID:18309951

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.

The economic burden of patient safety targets in acute care: a systematic review

PubMed Central

Mittmann, Nicole; Koo, Marika; Daneman, Nick; McDonald, Andrew; Baker, Michael; Matlow, Anne; Krahn, Murray; Shojania, Kaveh G; Etchells, Edward

2012-01-01

Background Our objective was to determine the quality of literature in costing of the economic burden of patient safety. Methods We selected 15 types of patient safety targets for our systematic review. We searched the literature published between 2000 and 2010 using the following terms: “costs and cost analysis,” “cost-effectiveness,” “cost,” and “financial management, hospital.” We appraised the methodologic quality of potentially relevant studies using standard economic methods. We recorded results in the original currency, adjusted for inflation, and then converted to 2010 US dollars for comparative purposes (2010 US$1.00 = 2010 €0.76). The quality of each costing study per patient safety target was also evaluated. Results We screened 1948 abstracts, and identified 158 potentially eligible studies, of which only 61 (39%) reported any costing methodology. In these 61 studies, we found wide estimates of the attributable costs of patient safety events ranging from $2830 to $10,074. In general hospital populations, the cost per case of hospital-acquired infection ranged from $2132 to $15,018. Nosocomial bloodstream infection was associated with costs ranging from $2604 to $22,414. Conclusion There are wide variations in the estimates of economic burden due to differences in study methods and methodologic quality. Greater attention to methodologic standards for economic evaluations in patient safety is needed. PMID:23097615

Lumbar Spinal Stenosis Minimally Invasive Treatment with Bilateral Transpedicular Facet Augmentation System

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

Masala, Salvatore, E-mail: salva.masala@tiscali.it; Tarantino, Umberto; Nano, Giovanni, E-mail: gionano@gmail.com

Purpose. The purpose of this study was to evaluate the effectiveness of a new pedicle screw-based posterior dynamic stabilization device PDS Percudyn System Trade-Mark-Sign Anchor and Stabilizer (Interventional Spine Inc., Irvine, CA) as alternative minimally invasive treatment for patients with lumbar spine stenosis. Methods. Twenty-four consecutive patients (8 women, 16 men; mean age 61.8 yr) with lumbar spinal stenosis underwent implantation of the minimally invasive pedicle screw-based device for posterior dynamic stabilization. Inclusion criteria were lumbar stenosis without signs of instability, resistant to conservative treatment, and eligible to traditional surgical posterior decompression. Results. Twenty patients (83 %) progressively improved duringmore » the 1-year follow-up. Four (17 %) patients did not show any improvement and opted for surgical posterior decompression. For both responder and nonresponder patients, no device-related complications were reported. Conclusions. Minimally invasive PDS Percudyn System Trade-Mark-Sign has effectively improved the clinical setting of 83 % of highly selected patients treated, delaying the need for traditional surgical therapy.« less

Why is recruitment to trials difficult? An investigation into recruitment difficulties in an RCT of supported employment in patients with severe mental illness

PubMed Central

Howard, Louise; de Salis, Isabel; Tomlin, Zelda; Thornicroft, Graham; Donovan, Jenny

2009-01-01

Background Under-recruitment to randomised controlled trials (RCTs) is often problematic and there may be particular difficulties in recruiting patients with severe mental illness. Aim To evaluate reasons for under-recruitment in an RCT of patients with severe mental illness Methods Qualitative study during the recruitment phase of an RCT of supported employment. Trial staff and recruiting clinicians were interviewed. Data were analyzed thematically using constant comparative techniques. Results Recruitment rates were low. Five main reasons for recruitment difficulties were found. These included: (i) misconceptions about trials, (ii) lack of equipoise, (iii) misunderstanding of the trial arms, (iv) variable interpretations of eligibility criteria, (v) paternalism. Conclusion Reasons for recruitment difficulties in trials involving patients with severe mental illness include issues that occur in trials in general, but others are more specific to these patients. Clinician and patient involvement in the study design may improve recruitment in future similar trials. PMID:18718555

A multi-method review of home-based chemotherapy.

PubMed

Evans, J M; Qiu, M; MacKinnon, M; Green, E; Peterson, K; Kaizer, L

2016-09-01

This study summarises research- and practice-based evidence on home-based chemotherapy, and explores existing delivery models. A three-pronged investigation was conducted consisting of a literature review and synthesis of 54 papers, a review of seven home-based chemotherapy programmes spanning four countries, and two case studies within the Canadian province of Ontario. The results support the provision of home-based chemotherapy as a safe and patient-centred alternative to hospital- and outpatient-based service. This paper consolidates information on home-based chemotherapy programmes including services and drugs offered, patient eligibility criteria, patient views and experiences, delivery structures and processes, and common challenges. Fourteen recommendations are also provided for improving the delivery of chemotherapy in patients' homes by prioritising patient-centredness, provider training and teamwork, safety and quality of care, and programme management. The results of this study can be used to inform the development of an evidence-informed model for the delivery of chemotherapy and related care, such as symptom management, in patients' homes. © 2015 John Wiley & Sons Ltd.

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.

Defibrotide for prophylaxis of hepatic veno-occlusive disease in paediatric haemopoietic stem-cell transplantation: an open-label, phase 3, randomised controlled trial.

PubMed

Corbacioglu, Selim; Cesaro, Simone; Faraci, Maura; Valteau-Couanet, Dominique; Gruhn, Bernd; Rovelli, Attilio; Boelens, Jaap J; Hewitt, Annette; Schrum, Johanna; Schulz, Ansgar S; Müller, Ingo; Stein, Jerry; Wynn, Robert; Greil, Johann; Sykora, Karl-Walter; Matthes-Martin, Susanne; Führer, Monika; O'Meara, Anne; Toporski, Jacek; Sedlacek, Petr; Schlegel, Paul G; Ehlert, Karoline; Fasth, Anders; Winiarski, Jacek; Arvidson, Johan; Mauz-Körholz, Christine; Ozsahin, Hulya; Schrauder, Andre; Bader, Peter; Massaro, Joseph; D'Agostino, Ralph; Hoyle, Margaret; Iacobelli, Massimo; Debatin, Klaus-Michael; Peters, Christina; Dini, Giorgio

2012-04-07

Hepatic veno-occlusive disease is a leading cause of morbidity and mortality after haemopoietic stem-cell transplantation (HSCT). We aimed to assess whether defibrotide can reduce the incidence of veno-occlusive disease in this setting. In our phase 3 open-label, randomised controlled trial, we enrolled patients at 28 European university hospitals or academic medical centres. Eligible patients were younger than 18 years, had undergone myeloablative conditioning before allogeneic or autologous HSCT, and had one or more risk factor for veno-occlusive disease based on modified Seattle criteria. We centrally assigned eligible participants on the basis of a computer-generated randomisation sequence (1:1), stratified by centre and presence of osteopetrosis, to receive intravenous defibrotide prophylaxis (treatment group) or not (control group). The primary endpoint was incidence of veno-occlusive disease by 30 days after HSCT, adjudicated by a masked, independent review committee, in eligible patients who consented to randomisation (intention-to-treat population), and was assessed with a competing risk approach. Patients in either group who developed veno-occlusive disease received defibrotide for treatment. We assessed adverse events to 180 days after HSCT in all patients who received allocated prophylaxis. This trial is registered with ClinicalTrials.gov, number NCT00272948. Between Jan 25, 2006, and Jan 29, 2009, we enrolled 356 eligible patients to the intention-to-treat population. 22 (12%) of 180 patients randomly allocated to the defibrotide group had veno-occlusive disease by 30 days after HSCT compared with 35 (20%) of 176 controls (risk difference -7·7%, 95% CI -15·3 to -0·1; Z test for competing risk analysis p=0·0488; log-rank test p=0·0507). 154 (87%) of 177 patients in the defibrotide group had adverse events by day 180 compared with 155 (88%) of 176 controls. Defibrotide prophylaxis seems to reduce incidence of veno-occlusive disease and is well tolerated. Thus, such prophylaxis could present a useful clinical option for this serious complication of HSCT. Gentium SpA, European Group for Blood and Marrow Transplantation. Copyright © 2012 Elsevier Ltd. All rights reserved.

Meta-analysis of neutropenia or leukopenia as a prognostic factor in patients with malignant disease undergoing chemotherapy.

PubMed

Shitara, Kohei; Matsuo, Keitaro; Oze, Isao; Mizota, Ayako; Kondo, Chihiro; Nomura, Motoo; Yokota, Tomoya; Takahari, Daisuke; Ura, Takashi; Muro, Kei

2011-08-01

We performed a systematic review and meta-analysis to determine the impact of neutropenia or leukopenia experienced during chemotherapy on survival. Eligible studies included prospective or retrospective analyses that evaluated neutropenia or leukopenia as a prognostic factor for overall survival or disease-free survival. Statistical analyses were conducted to calculate a summary hazard ratio and 95% confidence interval (CI) using random-effects or fixed-effects models based on the heterogeneity of the included studies. Thirteen trials were selected for the meta-analysis, with a total of 9,528 patients. The hazard ratio of death was 0.69 (95% CI, 0.64-0.75) for patients with higher-grade neutropenia or leukopenia compared to patients with lower-grade or lack of cytopenia. Our analysis was also stratified by statistical method (any statistical method to decrease lead-time bias; time-varying analysis or landmark analysis), but no differences were observed. Our results indicate that neutropenia or leukopenia experienced during chemotherapy is associated with improved survival in patients with advanced cancer or hematological malignancies undergoing chemotherapy. Future prospective analyses designed to investigate the potential impact of chemotherapy dose adjustment coupled with monitoring of neutropenia or leukopenia on survival are warranted.

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.

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.

Rapid Implementation of Evidence-Based Guidelines for Imaging After First Urinary Tract Infection

PubMed Central

Elkeeb, Dena; Weiser, Jason; Brinkman, William B.

2013-01-01

BACKGROUND AND OBJECTIVES: The American Academy of Pediatrics published a new guideline for management of first urinary tract infection (UTI) in children aged 2 to 24 months in September 2011. The imaging evaluation changed from the previous guideline to recommend voiding cystourethrogram (VCUG) only for patients with an abnormal renal and bladder ultrasound (RBUS). The objective was to decrease the proportion of guideline-eligible children with a normal RBUS who underwent VCUG from median of 92% for patients treated as inpatients and 100% for patients treated in the emergency department to 5% in both settings. METHODS: This was a quality improvement implementation study in a large academic medical center. Key drivers included: appropriate guideline knowledge, timely identification of guideline eligible patients, and effective communication with the community-based primary care provider. A multidisciplinary team developed and tested interventions. Impact was assessed with annotated run charts. Statistical comparisons were made with χ2 analysis and Fisher’s exact test. RESULTS: The proportion of children with first UTI and normal RBUS who underwent VCUG decreased from a median of 92% to 0% within 1 month of initiating the project among those hospitalized and from 100% to 40% within 4 months among those diagnosed in the emergency department. Rates have been sustained for 12 months and 8 months, respectively. Interventions using the electronic medical record and ordering system were most impactful. CONCLUSIONS: Rapid adoption of evidence-based UTI care across multiple settings is achievable. Practice change occurred faster and to a greater magnitude in the inpatient setting compared with the outpatient setting. PMID:23958774

A novel approach to measuring response and remission in schizophrenia in clinical trials.

PubMed

Aboraya, Ahmed; Leucht, Stefan; Nasrallah, Henry A; Samara, Myrto; Haro, Josep Maria; Elshazly, Ahmed; Zangeneh, Masood

2017-12-01

Pharmaceutical companies conduct clinical trials to show the efficacy and safety of new medications for the treatment of schizophrenia. After the new medications are marketed, clinicians treating patients with schizophrenia discover that a considerable number of patients do not respond to these new medications. The goals of the review are to examine the methodology and design of recent antipsychotic clinical trials, identify common flaws, and propose guidelines to fix the flaws and improve the quality of future clinical trials of antipsychotic medications. A review of recent antipsychotic clinical trials was conducted using a PubMed search. Ten recent trials published in the past four years were reviewed and their methods analyzed and critiqued. The authors identified six major methodological flaws that may explain the suboptimal response in many patients after a drug is approved. Most of the flaws are related to eligibility criteria, the misuse of the Positive and Negative Syndromes Scale (PANSS) and the lack of consensus on how to define remission, response and exacerbation in schizophrenia. Proposed guidelines for a more rigorous use of the PANSS are presented and recommendations are proposed for using uniform criteria for remission, response and exacerbation in schizophrenia. The authors recommend using standardized diagnostic interviews to screen patients for eligibility criteria and using the PANSS according to the author's recommendations and the proposed guidelines. Uniform criteria to define remission, response and exacerbation are recommended for clinical trials examining the efficacy and safety of antipsychotic drugs in schizophrenia. Copyright © 2017 Elsevier B.V. All rights reserved.

Influence of Cranial Radiotherapy on Outcome in Children With Acute Lymphoblastic Leukemia Treated With Contemporary Therapy

PubMed Central

Andreano, Anita; Pui, Ching-Hon; Hunger, Stephen P.; Schrappe, Martin; Moericke, Anja; Biondi, Andrea; Escherich, Gabriele; Silverman, Lewis B.; Goulden, Nicholas; Taskinen, Mervi; Pieters, Rob; Horibe, Keizo; Devidas, Meenakshi; Locatelli, Franco; Valsecchi, Maria Grazia

2016-01-01

Purpose We sought to determine whether cranial radiotherapy (CRT) is necessary to prevent relapse in any subgroup of children with acute lymphoblastic leukemia (ALL). Patients and Methods We obtained aggregate data on relapse and survival outcomes for 16,623 patients age 1 to 18 years old with newly diagnosed ALL treated between 1996 and 2007 by 10 cooperative study groups from around the world. The proportion of patients eligible for prophylactic CRT varied from 0% to 33% by trial and was not related to the proportion eligible for allogeneic stem-cell transplantation in first complete remission. Using a random effects model, with CRT as a dichotomous covariate, we performed a single-arm meta-analysis to compare event-free survival and cumulative incidence of isolated or any CNS relapse and isolated bone marrow relapse in high-risk subgroups of patients who either did or did not receive CRT. Results Although there was significant heterogeneity in all outcome end points according to trial, CRT was associated with a reduced risk of relapse only in the small subgroup of patients with overt CNS disease at diagnosis, who had a significantly lower risk of isolated CNS relapse (4% with CRT v 17% without CRT; P = .02) and a trend toward lower risk of any CNS relapse (7% with CRT v 17% without CRT; P = .09). However, this group had a relatively high rate of events regardless of whether or not they received CRT (32% [95% CI, 26% to 39%] v 34% [95% CI, 19% to 54%]; P = .8). Conclusion CRT does not have an impact on the risk of relapse in children with ALL treated on contemporary protocols. PMID:26755523

Trimodality strategy for treating malignant pleural mesothelioma: results of a feasibility study of induction pemetrexed plus cisplatin followed by extrapleural pneumonectomy and postoperative hemithoracic radiation (Japan Mesothelioma Interest Group 0601 Trial).

PubMed

Hasegawa, Seiki; Okada, Morihito; Tanaka, Fumihiro; Yamanaka, Takeharu; Soejima, Toshinori; Kamikonya, Norihiko; Tsujimura, Tohru; Fukuoka, Kazuya; Yokoi, Kohei; Nakano, Takashi

2016-06-01

We conducted a prospective multi-institutional study to determine the feasibility of trimodality therapy (TMT) comprising induction chemotherapy followed by extrapleural pneumonectomy (EPP) and radiation therapy in Japanese patients with malignant pleural mesothelioma (MPM). Major eligibility criteria were histologically confirmed diagnosis of MPM, including clinical subtypes T0-3, N0-2, M0 disease; no prior treatment for the disease; age 20-75 years; Eastern Cooperative Oncology Group performance status 0 or 1; predicted postoperative forced expiratory volume >1000 ml in 1 s; written informed consent. Treatment methods comprised induction chemotherapy using pemetrexed (500 mg/m(2)) plus cisplatin (60 mg/m(2)) for three cycles, followed by EPP and postoperative hemithoracic radiation therapy (54 Gy). Primary endpoints were macroscopic complete resection (MCR) rate for EPP and treatment-related mortality for TMT. Forty-two eligible patients were enrolled: median age 64.5 (range 43-74) years; M:F = 39:3, clinical stage I:II:III = 14:13:15; histological type epithelioid were sarcomatoid; biphasic; others = 28:1:9:4. Of 42 patients, 30 completed EPP with MCR and 17 completed TMT. The trial met the primary endpoints, with an MCR rate of 71 % (30/42) and treatment-related mortality of 9.5 % (4/42). Overall median survival time and 2-year survival rate for 42 registered patients were 19.9 months and 42.9 %, respectively. Two-year relapse-free survival rate of 30 patients who completed EPP with MCR was 37.0 %. This phase II study met the predefined primary endpoints, but its risk/benefit ratio was not satisfactory.

Changing the South African national antiretroviral therapy guidelines: The role of cost modelling

PubMed Central

Johnson, Leigh F.; Pillay, Yogan; Blecher, Mark; Brennan, Alana T.; Long, Lawrence; Moultrie, Harry; Sanne, Ian; Fox, Matthew P.; Rosen, Sydney

2017-01-01

Background We were tasked by the South African Department of Health to assess the cost implications to the largest ART programme in the world of adopting sets of ART guidelines issued by the World Health Organization between 2010 and 2016. Methods Using data from large South African ART clinics (n = 24,244 patients), projections of patients in need of ART, and cost data from bottom-up cost analyses, we constructed a population-level health-state transition model with 6-monthly transitions between health states depending on patients’ age, CD4 cell count/ percentage, and, for adult first-line ART, time on treatment. Findings For each set of guidelines, the modelled increase in patient numbers as a result of prevalence and uptake was substantially more than the increase resulting from additional eligibility. Under each set of guidelines, the number of people on ART was projected to increase by 31–133% over the next seven years, and cost by 84–175%, while increased eligibility led to 1–26% more patients, and 1–17% higher cost. The projected increases in treatment cost due to the 2010 and the 2015 WHO guidelines could be offset in their entirety by the introduction of cost-saving measures such as opening the drug tenders for international competition and task-shifting. Under universal treatment, annual costs of the treatment programme will decrease for the first time from 2024 onwards. Conclusions Annual budgetary requirements for ART will continue to increase in South Africa until universal treatment is taken to full scale. Model results were instrumental in changing South African ART guidelines, more than tripling the population on treatment between 2009 and 2017, and reducing the per-patient cost of treatment by 64%. PMID:29084275

Is Thrombocytopenia an Early Prognostic Marker in Septic Shock?

PubMed

Thiery-Antier, Nadiejda; Binquet, Christine; Vinault, Sandrine; Meziani, Ferhat; Boisramé-Helms, Julie; Quenot, Jean-Pierre

2016-04-01

To assess whether early thrombocytopenia during septic shock is associated with an increased risk of death at day 28 and to identify risk factors associated with a low platelet count. Prospective, multicenter, observational cohort study. Fourteen ICUs from 10 French university teaching and nonacademic hospitals. Consecutive adult patients with septic shock admitted between November 2009 and September 2011 were eligible. None. Of the 1,495 eligible patients, 1,486 (99.4%) were included. Simplified Acute Physiology Score II score of greater than or equal to 56, immunosuppression, age of more than 65 years, cirrhosis, bacteremia (p ≤ 0.001 for each), and urinary sepsis (p = 0.005) were globally associated with an increased risk of thrombocytopenia within the first 24 hours following the onset of septic shock. Survival at day 28 estimated by the Kaplan-Meier method was lower in patients with thrombocytopenia and decreased with thrombocytopenia severity. By multivariate Cox regression, a platelet count of less than or equal to 100,000/mm3 was independently associated with a significantly increased risk of death within the 28 days following septic shock onset. The risk of death increased with the severity of thrombocytopenia (hazard ratio, 1.65; 95% CI, 1.31-2.08 for a platelet count below 50,000/mm3 vs > 150,000/mm3; p < 0.0001). This is the first study to investigate thrombocytopenia within the first 24 hours of septic shock onset as a prognostic marker of survival at day 28 in a large cohort of ICU patients. Measuring platelet count is inexpensive and easily feasible for the physician in routine practice, and thus, it could represent an easy "alert system" among patients in septic shock.

Prevention and Periodontal Treatment in Down Syndrome Patients: A Systematic Review

PubMed Central

Greghi, Sebastião Luiz Aguiar; de Resende, Maria Lúcia Rubo; Sant’Ana, Adriana Campos Passanezi; Damante, Carla Andreotti

2016-01-01

The aim of this systematic literature review was to evaluate which type of periodontal preventive and therapeutic approaches presents superior outcomes in patients with Down syndrome (DS). Studies reporting different methods of periodontal care from DS patients were considered eligible. Included clinical studies should indicate at least two periodontal parameters in different periods of assessment. Screening of the articles, data extraction and quality assessment were conducted independently and in duplicate. Electronic search according to the PICO search, with both Key-words and MESH terms were conducted in MEDLINE, EMBASE and CENTRAL databases until March 2016. Manual search was conducted in four journals, namely Journal of Periodontology, Journal of Clinical Periodontology, Journal of Periodontal Research and Special Care in Dentistry and their electronic databases were searched. Electronic and manual search resulted in 763 papers, and of them 744 were excluded after title/abstract assessment. The full text of 19 potentially eligible publications was screened and 9 studies met inclusion criteria. The results demonstrated the importance to introduce youngest DS patients in preventive programs, as well as participation of parents, caregivers or institutional attendants in supervising/performing oral hygiene. In studies with higher frequency of attendance, all age groups presented superior preventive and therapeutic results, irrespective of the therapeutic approach used (surgical/nonsurgical/periodontal care program). The important factors for reducing periodontal parameters were the frequency of the appointments and association with chlorhexidine/plaque disclosing agents as adjuvant treatment. This systematic review demonstrated that early introduction in periodontal care, participation of parents/caregivers/institutional attendants, frequency of attendance and association with chemical adjuvants (independently of the periodontal treatment adopted) seems to improve periodontal outcomes in preventive and periodontal treatment of DS patients. Registration number (Prospero): CRD42016038433. PMID:27355338

The efficacy of balloon dilation in achalasia is the result of stretching of the lower esophageal sphincter, not muscular disruption.

PubMed

Borhan-Manesh, F; Kaviani, M J; Taghavi, A R

2016-04-01

Pneumatic dilation (PD) of the lower esophageal sphincter (LES) in achalasia is a major palliative treatment. It is generally believed, although never substantiated, that therapeutic efficacy of ballooning in achalasia is the result of the disruption and tearing of the muscular layers of the LES. To clarify this issue, we investigated the frequency of muscular disruption at the LES, 24 hours after PD, by employing the endoscopic ultrasound (EUS), in a group of 43 consented patients with achalasia. Between July 2009 and March2012, 51 consecutive adult patients with tentative diagnosis of achalasia, some with recurrence of symptoms after an earlier treatment with balloon dilation, were evaluated and underwent PD, using Rigiflex balloon without major adverse effect. Out of the 51 evaluated, 43 eligible and consenting patients who underwent EUS, 24 hours after PD, using Olympus GF-UE 160 echoendoscope and an Aloka Prosound probe at 7.5 MHZ, are the subjects of this study. The EUS in 43 eligible patients revealed an intact LES in 36 (83.7%), small area of muscular disruption in 5 (11.6%) and small hematoma in 2 patients (4.6%). Our data convincingly demonstrate that the clinical effectiveness of balloon dilation in achalasia is not the result of muscular disruption, but of circumferential stretching of the LES. Our findings on the mechanism of action of PD in achalasia could result in modifying the current method of dilation for a safer procedure, by slowing the rate of inflation and allowing the sphincter to slowly stretch itself to the distending balloon. © 2015 The Authors. Diseases of the Esophagus published by Wiley Periodicals, Inc. on behalf of International Society for Diseases of the Esophagus.

PS1-54: Clinical Perspectives on Under- and Overutilization of Cervical Cancer Screening Services

PubMed Central

Coronado, Gloria; Petrik, Amanda; Spofford, Mark; Talbot, Jocelyn; Do, Huyen Hoai; Taylor, Vicky

2013-01-01

Background/Aims The underutilization of cancer screening services is an on-going concern to program planners and policy makers; such underutilization is common among under-insured, ethnic- and language-minority populations and is associated with advanced stage of disease detection, limited treatment options, and diminished survival. At the same time, growing research interest has focused on the over-utilization of cancer screening services. We sought to gather the perceptions of clinic personnel at Latino-serving federally qualified health centers about patients’ utilization of screening services for cervical cancer. Methods We conducted one-on-one interviews among 17 clinic personnel at four Latino-serving federally qualified health center networks in Oregon. Results Estimated proportions of eligible patients who are under-screened ranged from 20% to 60%, with 30% most commonly cited. Under-screening for cervical cancer was thought to occur among low-income, under-insured and undocumented patients. External factors, such as limited funding to pay for screening and access barriers to follow-up testing in patients with positive screens were cited as contributing to under-screening. The most frequently cited proportion of eligible patients who are over-screened was 10%, and ranged from 10% to 50%. Notably, over-screening for cervical cancer was thought to occur among young women (those younger than 21) and women with a recent pregnancy. Inconsistent capture of history of screening in electronic medical records and unclear and changing screening guidelines were thought to contribute to over-screening in some patients. Conclusions The health care providers we interviewed had widely varying perspectives of the under- and over-utilization of screening services for cervical cancer. Our findings may inform future efforts to promote guideline-appropriate cancer screening and coordinated follow-up care.

ECONOMIC AND PUBLIC HEALTH IMPACTS OF POLICIES RESTRICTING ACCESS TO HEPATITIS C TREATMENT FOR MEDICAID PATIENTS

PubMed Central

Chidi, Alexis P.; Bryce, Cindy L.; Donohue, Julie; Fine, Michael J.; Landsittel, Doug; Myaskovsky, Larissa; Rogal, Shari; Switzer, Galen; Tsung, Allan; Smith, Kenneth

2016-01-01

INTRODUCTION Interferon-free hepatitis C treatment regimens are effective but very costly. The cost-effectiveness, budget and public health impacts of current Medicaid treatment policies restricting treatment to patients with advanced disease remain unknown. METHODS Using a Markov model, we compared two strategies for 45–55 year old Medicaid beneficiaries: (1) Current Practice - only advanced disease is treated before Medicare eligibility; and (2) Full Access – both early-stage and advanced disease are treated before Medicare eligibility. Patients could develop progressive fibrosis, cirrhosis or hepatocellular carcinoma, undergo transplantation, or die each year. Morbidity was reduced after successful treatment. We calculated the incremental cost-effectiveness ratio and compared the costs and public health effects of each strategy from the perspective of Medicare alone as well as the Centers for Medicare and Medicaid Services (CMS) perspective. We varied model inputs in one-way and probabilistic sensitivity analyses. RESULTS Full Access was less costly and more effective than Current Practice for all cohorts and perspectives, with differences in cost from $5,369–$11,960 and in effectiveness from 0.82–3.01 quality adjusted life-years). In a probabilistic sensitivity analysis, Full Access was cost saving in 93% of model iterations. Compared to Current Practice, Full Access averted 5,994 hepatocellular carcinoma cases and 121 liver transplants per 100,000 patients. CONCLUSIONS Current Medicaid policies restricting hepatitis C treatment to patients with advanced disease are more costly and less effective than unrestricted, full access strategies. Collaboration between state and federal payers may be needed to realize the full public health impact of recent innovations in hepatitis C treatment. PMID:27325324

Computerized clinical decision support systems for chronic disease management: A decision-maker-researcher partnership systematic review

PubMed Central

2011-01-01

Background The use of computerized clinical decision support systems (CCDSSs) may improve chronic disease management, which requires recurrent visits to multiple health professionals, ongoing disease and treatment monitoring, and patient behavior modification. The objective of this review was to determine if CCDSSs improve the processes of chronic care (such as diagnosis, treatment, and monitoring of disease) and associated patient outcomes (such as effects on biomarkers and clinical exacerbations). Methods We conducted a decision-maker-researcher partnership systematic review. We searched MEDLINE, EMBASE, Ovid's EBM Reviews database, Inspec, and reference lists for potentially eligible articles published up to January 2010. We included randomized controlled trials that compared the use of CCDSSs to usual practice or non-CCDSS controls. Trials were eligible if at least one component of the CCDSS was designed to support chronic disease management. We considered studies 'positive' if they showed a statistically significant improvement in at least 50% of relevant outcomes. Results Of 55 included trials, 87% (n = 48) measured system impact on the process of care and 52% (n = 25) of those demonstrated statistically significant improvements. Sixty-five percent (36/55) of trials measured impact on, typically, non-major (surrogate) patient outcomes, and 31% (n = 11) of those demonstrated benefits. Factors of interest to decision makers, such as cost, user satisfaction, system interface and feature sets, unique design and deployment characteristics, and effects on user workflow were rarely investigated or reported. Conclusions A small majority (just over half) of CCDSSs improved care processes in chronic disease management and some improved patient health. Policy makers, healthcare administrators, and practitioners should be aware that the evidence of CCDSS effectiveness is limited, especially with respect to the small number and size of studies measuring patient outcomes. PMID:21824386

Impact of the NTCP modeling on medical decision to select eligible patient for proton therapy: the usefulness of EUD as an indicator to rank modern photon vs proton treatment plans.

PubMed

Chaikh, Abdulhamid; Calugaru, Valentin; Bondiau, Pierre-Yves; Thariat, Juliette; Balosso, Jacques

2018-06-07

The aim of this study is to evaluate the impact of normal tissue complication probability (NTCP)-based radiobiological models on the estimated risk for late radiation lung damages. The second goal is to propose a medical decision-making approach to select the eligible patient for particle therapy. 14 pediatric patients undergoing cranio-spinal irradiation were evaluated. For each patient, two treatment plans were generated using photon and proton therapy with the same dose prescriptions. Late radiation damage to lung was estimated using three NTCP concepts: the Lyman-Kutcher-Burman, the equivalent uniform dose (EUD) and the mean lung dose according to the quantitative analysis of normal tissue effects in the clinic QUANTEC review. Wilcoxon paired test was used to calculate p-value. Proton therapy achieved lower lung EUD (Gy). The average NTCP values were significantly lower with proton plans, p < 0.05, using the three NTCP concepts. However, applying the same TD 50/5 using radiobiological models to compare NTCP from proton and photon therapy, the ΔNTCP was not a convincing method to measure the potential benefit of proton therapy. Late radiation pneumonitis estimated from the mean lung dose model correlated with QUANTEC data better. treatment effectiveness assessed on NTCP reduction depends on radiobiological predictions and parameters used as inputs for in silico evaluation. Since estimates of absolute NTCP values from LKB and GN models are imprecise due to EUD ≪ TD 50/5 , a reduction of the EUD value with proton plans would better predict a reduction of dose/toxicity. The EUD concept appears as a robust radiobiological surrogate of the dose distribution to select the optimal patient's plan.

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.

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.

Why hasn't this patient been screened for colon cancer? An Iowa Research Network study.

PubMed

Levy, Barcey T; Nordin, Terri; Sinift, Suzanne; Rosenbaum, Marcy; James, Paul A

2007-01-01

Less than half of eligible Americans have been screened for colorectal cancer (CRC). The objective of this study was to describe physicians' reasons for screening or not screening specific patients for CRC and their approach to CRC testing discussions. This study used mixed-methods. Physicians described their reasons for screening or not screening 6 randomly chosen patients who were eligible for CRC screening (3 screened and 3 not screened) whose CRC testing status was ascertained by medical record review. Verbatim transcripts from physicians responding to structured interview questions were used to identify themes. Specific elements of discussion were examined for their association with each physician's screening rate. Fifteen randomly chosen Iowa family physicians from the Iowa Research Network stratified by privileges to perform colonoscopy, flexible sigmoidoscopy, or neither procedure dictated the reasons why 43 patients were screened and 40 patients were not screened. Reasons patients were not up to date fell into 2 major categories: (1) no discussion by physician (50%) and (2) patient refusal (43%). Reasons for no discussion included lack of opportunity, assessment that cost would be prohibitive, distraction by other life issues/health problems, physician forgetfulness, and expected patient refusal. Patients declined because of cost, lack of interest, autonomy, other life issues, fear of screening, and lack of symptoms. Patients who were up to date received (1) diagnostic testing (for previous colon pathology or symptoms; 56%) or (2) asymptomatic screening (44%). Physicians who were more adamant about screening had higher screening rates (P<.05; Wilcoxon rank sum). Physicians framed their recommendations differently ("I recommend" vs "They recommend"), with lower screening rates among physicians who used "they recommend" (P=.05; Wilcoxon rank sum). Reasons many patients remain unscreened for CRC include (1) factors related to the health care system, patient, and physician that impede or prevent discussion; (2) patient refusal; and (3) the focus on diagnostic testing. Strategies to improve screening might include patient and physician education about the rationale for screening, universal coverage for health maintenance exams, and development of effective tracking and reminder systems. The words physicians choose to frame their recommendations are important and should be explored further.

Systematic reviews identify important methodological flaws in stroke rehabilitation therapy primary studies: review of reviews.

PubMed

Santaguida, Pasqualina; Oremus, Mark; Walker, Kathryn; Wishart, Laurie R; Siegel, Karen Lohmann; Raina, Parminder

2012-04-01

A "review of reviews" was undertaken to assess methodological issues in studies evaluating nondrug rehabilitation interventions in stroke patients. MEDLINE, CINAHL, PsycINFO, and the Cochrane Database of Systematic Reviews were searched from January 2000 to January 2008 within the stroke rehabilitation setting. Electronic searches were supplemented by reviews of reference lists and citations identified by experts. Eligible studies were systematic reviews; excluded citations were narrative reviews or reviews of reviews. Review characteristics and criteria for assessing methodological quality of primary studies within them were extracted. The search yielded 949 English-language citations. We included a final set of 38 systematic reviews. Cochrane reviews, which have a standardized methodology, were generally of higher methodological quality than non-Cochrane reviews. Most systematic reviews used standardized quality assessment criteria for primary studies, but not all were comprehensive. Reviews showed that primary studies had problems with randomization, allocation concealment, and blinding. Baseline comparability, adverse events, and co-intervention or contamination were not consistently assessed. Blinding of patients and providers was often not feasible and was not evaluated as a source of bias. The eligible systematic reviews identified important methodological flaws in the evaluated primary studies, suggesting the need for improvement of research methods and reporting. Copyright © 2012 Elsevier Inc. All rights reserved.

Phase III Trial of Chemoradiotherapy for Anaplastic Oligodendroglioma: Long-Term Results of RTOG 9402

PubMed Central

Cairncross, Gregory; Wang, Meihua; Shaw, Edward; Jenkins, Robert; Brachman, David; Buckner, Jan; Fink, Karen; Souhami, Luis; Laperriere, Normand; Curran, Walter; Mehta, Minesh

2013-01-01

Purpose Anaplastic oligodendrogliomas, pure (AO) and mixed (anaplastic oligoastrocytoma [AOA]), are chemosensitive, especially if codeleted for 1p/19q, but whether patients live longer after chemoradiotherapy is unknown. Patients and Methods Eligible patients with AO/AOA were randomly assigned to procarbazine, lomustine, and vincristine (PCV) plus radiotherapy (RT) versus RT alone. The primary end point was overall survival (OS). Results Two hundred ninety-one eligible patients were randomly assigned: 148 to PCV plus RT and 143 to RT. For the entire cohort, there was no difference in median survival by treatment (4.6 years for PCV plus RT v 4.7 years for RT; hazard ratio [HR] = 0.79; 95% CI, 0.60 to 1.04; P = .1). Patients with codeleted tumors lived longer than those with noncodeleted tumors (PCV plus RT: 14.7 v 2.6 years, HR = 0.36, 95% CI, 0.23 to 0.57, P < .001; RT: 7.3 v 2.7 years, HR = 0.40, 95% CI, 0.27 to 0.60, P < .001), and the median survival of those with codeleted tumors treated with PCV plus RT was twice that of patients receiving RT (14.7 v 7.3 years; HR = 0.59; 95% CI, 0.37 to 0.95; P = .03). For those with noncodeleted tumors, there was no difference in median survival by treatment arm (2.6 v 2.7 years; HR = 0.85; 95% CI, 0.58 to 1.23; P = .39). In Cox models that included codeletion status, the adjusted OS for all patients was prolonged by PCV plus RT (HR = 0.67; 95% CI, 0.50 to 0.91; P = .01). Conclusion For the subset of patients with 1p/19q codeleted AO/AOA, PCV plus RT may be an especially effective treatment, although this observation was derived from an unplanned analysis. PMID:23071247

Impact of Patient Sex on Clinical Outcomes

PubMed Central

Teitsma, Xavier M.; van der Hoeven, Henk; Tamminga, Rob; de Bie, Rob A.

2014-01-01

Background: The Combined Quality Care Anterior Cruciate Ligament registry provides data for clinical research regarding primary anterior cruciate ligament (ACL) surgery. Purpose: To explore the data with regard to the clinical outcomes between sexes after ACL reconstruction in a Dutch population. Study Design: Cohort study; Level of evidence, 3. Methods: Data involving patients diagnosed with an ACL tear and eligible for surgery were recorded. Isokinetic muscle strength, functional muscle performance, and anterior-posterior translation of the knee joint were documented preoperatively and at 3, 6, 9, and 12 months postoperatively. Patients completed the Knee Injury and Osteoarthritis Outcome Score (KOOS), Lysholm, and Tegner rating scales during each examination using a web-based questionnaire. Results: Approximately 90% of ACL injuries occurred during sport activities. The mean (SD) age at surgery was 28 (11) years for both men and women, and the majority of patients were treated with hamstring tendon autografts (94%). Four percent received bone–patellar tendon–bone autografts, and 2% of the patients received other grafts. Preoperatively, the KOOS, Lysholm, and Tegner scores were significantly higher in males. Twelve months postoperatively, both sexes showed comparable isokinetic strength (P = .336), knee laxity (P = .680), and hop test for distance (P = .122) when comparing the injured with the uninjured side. Self-reported knee function was comparable between sexes as assessed by the KOOS (P = .202), Lysholm (P = .872), and Tegner (P = .767) questionnaires during the 12-month follow-up. Conclusion: One year after ACL surgery, all patients had improved greatly, showing only minor differences between sexes. The male group showed slightly better results when evaluating self-reported knee questionnaires. Comparable outcomes and knee function between sexes can therefore be presumed with patients who are treated with hamstring tendon autografts in a Dutch population. Clinical Relevance: These results can be used during the clinical evaluation of patients who are eligible for ACL reconstruction. PMID:26535365

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

Primary Analysis of a Phase II Randomized Trial Radiation Therapy Oncology Group (RTOG) 0212: Impact of Different Total Doses and Schedules of Prophylactic Cranial Irradiation on Chronic Neurotoxicity and Quality of Life for Patients With Limited-Disease Small-Cell Lung Cancer

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

Wolfson, Aaron H., E-mail: awolfson@med.miami.edu; Bae, Kyounghwa; Komaki, Ritsuko

2011-09-01

Purpose: To determine the effect of dose and fractionation schedule of prophylactic cranial irradiation (PCI) on the incidence of chronic neurotoxicity (CNt) and changes in quality of life for selected patients with limited-disease small-cell lung cancer (LD SCLC). Methods and Materials: Patients with LD SCLC who achieved a complete response after chemotherapy and thoracic irradiation were eligible for randomization to undergo PCI to a total dose of 25 Gy in 10 daily fractions (Arm 1) vs. the experimental cohort of 36 Gy. Those receiving 36 Gy underwent a secondary randomization between daily 18 fractions (Arm 2) and twice-daily 24 fractionsmore » (Arm 3). Enrolled patients participated in baseline and follow-up neuropsychological test batteries along with quality-of-life assessments. Results: A total of 265 patients were accrued, with 131 in Arm 1, 67 in Arm 2, and 66 in Arm 3 being eligible. There are 112 patients (42.2%) alive with 25.3 months of median follow-up. There were no significant baseline differences among groups regarding quality-of-life measures and one of the neuropsychological tests, namely the Hopkins Verbal Learning Test. However, at 12 months after PCI there was a significant increase in the occurrence of CNt in the 36-Gy cohort (p = 0.02). Logistic regression analysis revealed increasing age to be the most significant predictor of CNt (p = 0.005). Conclusions: Because of the increased risk of developing CNt in study patients with 36 Gy, a total PCI dose of 25 Gy remains the standard of care for patients with LD SCLC attaining a complete response to initial chemoradiation.« less

Phase II Trial of Combined High-Dose-Rate Brachytherapy and External Beam Radiotherapy for Adenocarcinoma of the Prostate: Preliminary Results of RTOG 0321

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

Hsu, I-Chow, E-mail: ihsu@radonc.ucsf.ed; Bae, Kyounghwa; Shinohara, Katsuto

2010-11-01

Purpose: To estimate the rate of late Grade 3 or greater genitourinary (GU) and gastrointestinal (GI) adverse events (AEs) after treatment with external beam radiotherapy and prostate high-dose-rate (HDR) brachytherapy. Methods and Materials: Each participating institution submitted computed tomography-based HDR brachytherapy dosimetry data electronically for credentialing and for each study patient. Patients with locally confined Stage T1c-T3b prostate cancer were eligible for the present study. All patients were treated with 45 Gy in 25 fractions using external beam radiotherapy and one HDR implant delivering 19 Gy in two fractions. All AEs were graded according to the Common Terminology Criteria formore » Adverse Events, version 3.0. Late GU/GI AEs were defined as those occurring >9 months from the start of the protocol treatment, in patients with {>=}18 months of potential follow-up. Results: A total of 129 patients from 14 institutions were enrolled in the present study. Of the 129 patients, 125 were eligible, and AE data were available for 112 patients at analysis. The pretreatment characteristics of the patients were as follows: Stage T1c-T2c, 91%; Stage T3a-T3b, 9%; prostate-specific antigen level {<=}10 ng/mL, 70%; prostate-specific antigen level >10 but {<=}20 ng/mL, 30%; and Gleason score 2-6, 10%; Gleason score 7, 72%; and Gleason score 8-10, 18%. At a median follow-up of 29.6 months, three acute and four late Grade 3 GU/GI AEs were reported. The estimated rate of late Grade 3-5 GU and GI AEs at 18 months was 2.56%. Conclusion: This is the first prospective, multi-institutional trial of computed tomography-based HDR brachytherapy and external beam radiotherapy. The technique and doses used in the present study resulted in acceptable levels of AEs.« less

Understanding clinicians’ decisions to offer intravenous thrombolytic treatment to patients with acute ischaemic stroke: a protocol for a discrete choice experiment

PubMed Central

De Brún,, Aoife; Flynn, Darren; Joyce, Kerry; Ternent, Laura; Price, Christopher; Rodgers, Helen; Ford, Gary A; Lancsar, Emily; Rudd, Matthew; Thomson, Richard G

2014-01-01

Background Intravenous thrombolysis is an effective emergency treatment for acute ischaemic stroke for patients meeting specific criteria. Approximately 12% of eligible patients in England, Wales and Northern Ireland received thrombolysis in the first quarter of 2013, yet as many as 15% are eligible to receive treatment. Suboptimal use of thrombolysis may have been largely attributable to structural factors; however, with the widespread implementation of 24/7 hyper acute stroke services, continuing variation is likely to reflect differences in clinical decision-making, in particular the influence of ambiguous areas within the guidelines, licensing criteria and research evidence. Clinicians’ perceptions about thrombolysis may now exert a greater influence on treatment rates than structural/service factors. This research seeks to elucidate factors influencing thrombolysis decision-making by using patient vignettes to identify (1) patient-related and clinician-related factors that may help to explain variation in treatment and (2) associated trade-offs in decision-making based on the interplay of critical factors. Methods/analysis A discrete choice experiment (DCE) will be conducted to better understand how clinicians make decisions about whether or not to offer thrombolysis to patients with acute ischaemic stroke. To inform the design, exploratory work will be undertaken to ensure that (1) all potentially influential factors are considered for inclusion; and (2) to gain insights into the ‘grey areas’ of patient factors. A fractional factorial design will be used to combine levels of patient factors in vignettes, which will be presented to clinicians to allow estimation of the variable effects on decisions to offer thrombolysis. Ethics and dissemination Ethical approval for this study was obtained from the Newcastle University Research Ethics Committee. The results will be disseminated in peer review publications and at national conferences. Findings will be translated into continuing professional development activities and will support implementation of a computerised decision aid for thrombolysis (COMPASS) in acute stroke care. PMID:25009137

Frailty Screening Tools for Elderly Patients Incident to Dialysis.

PubMed

van Loon, Ismay N; Goto, Namiko A; Boereboom, Franciscus T J; Bots, Michiel L; Verhaar, Marianne C; Hamaker, Marije E

2017-09-07

A geriatric assessment is an appropriate method for identifying frail elderly patients. In CKD, it may contribute to optimize personalized care. However, a geriatric assessment is time consuming. The purpose of our study was to compare easy to apply frailty screening tools with the geriatric assessment in patients eligible for dialysis. A total of 123 patients on incident dialysis ≥65 years old were included <3 weeks before to ≤2 weeks after dialysis initiation, and all underwent a geriatric assessment. Patients with impairment in two or more geriatric domains on the geriatric assessment were considered frail. The diagnostic abilities of six frailty screening tools were compared with the geriatric assessment: the Fried Frailty Index, the Groningen Frailty Indicator, Geriatric8, the Identification of Seniors at Risk, the Hospital Safety Program, and the clinical judgment of the nephrologist. Outcome measures were sensitivity, specificity, positive predictive value, and negative predictive value. In total, 75% of patients were frail according to the geriatric assessment. Sensitivity of frailty screening tools ranged from 48% (Fried Frailty Index) to 88% (Geriatric8). The discriminating features of the clinical judgment were comparable with the other screening tools. The Identification of Seniors at Risk screening tool had the best discriminating abilities, with a sensitivity of 74%, a specificity of 80%, a positive predictive value of 91%, and a negative predictive value of 52%. The negative predictive value was poor for all tools, which means that almost one half of the patients screened as fit (nonfrail) had two or more geriatric impairments on the geriatric assessment. All frailty screening tools are able to detect geriatric impairment in elderly patients eligible for dialysis. However, all applied screening tools, including the judgment of the nephrologist, lack the discriminating abilities to adequately rule out frailty compared with a geriatric assessment. Copyright © 2017 by the American Society of Nephrology.

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.

Reasons for HCV non-treatment in underserved African Americans: implications for treatment with new therapeutics.

PubMed

Schaeffer, Sarah; Khalili, Mandana

2015-01-01

African Americans are disproportionately affected by hepatitis C (HCV) and are less likely to undergo HCV treatment. Underserved populations are especially at risk for experiencing health disparity. Aim. To identify reasons for HCV non-treatment among underserved African Americans in a large safetynet system. Medical records of HCV-infected African Americans evaluated at San Francisco General Hospital liver specialty clinic from 2006-2011 who did not receive HCV treatment were reviewed. Treatment eligibility and reasons for non-treatment were assessed. Factors associated with treatment ineligibility were assessed using logistic regression modeling. Among 118 patients, 42% were treatment ineligible, 18% treatment eligible, and 40% were undergoing work-up to determine eligibility. Reasons for treatment ineligibility were medical (54%), non-medical (14%), psychiatric (4%), or combined (28%). When controlling for age and sex, active/recent substance abuse (OR 6.65, p = 0.001) and having two or more medical comorbidities (OR 3.39, p = 0.005) predicted treatment ineligibility. Excluding those ineligible for treatment, 72% of all other patients were lost to follow-up; they were older (55 vs. 48 years, p = 0.01) and more likely to be undergoing work up to determine treatment eligibility (86 vs. 21%, p < 0.0001) than those not lost to follow-up. Medical comorbidities and substance abuse predicted HCV treatment ineligibility in underserved African Americans. Importantly, the majority of those undergoing work-up to determine HCV treatment eligibility were lost to follow-up. While newer anti-HCV agents may increase treatment eligibility, culturally appropriate interventions to increase compliance with evaluation and care remain critical to HCV management in underserved African Americans.

Medicaid and Children's Health Insurance Programs: essential health benefits in alternative benefit plans, eligibility notices, fair hearing and appeal processes, and premiums and cost sharing; exchanges: eligibility and enrollment. Final rule.

PubMed

2013-07-15

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. This final rule finalizes new Medicaid eligibility provisions; finalizes changes related to electronic Medicaid and the Children's Health Insurance Program (CHIP) eligibility notices and delegation of appeals; modernizes and streamlines existing Medicaid eligibility rules; revises CHIP rules relating to the substitution of coverage to improve the coordination of CHIP coverage with other coverage; and amends requirements for benchmark and benchmark-equivalent benefit packages consistent with sections 1937 of the Social Security Act (which we refer to as ``alternative benefit plans'') to ensure that these benefit packages include essential health benefits and meet certain other minimum standards. This rule also implements specific provisions including those related to authorized representatives, notices, and verification of eligibility for qualifying coverage in an eligible employer-sponsored plan for Affordable Insurance Exchanges. This rule also updates and simplifies the complex Medicaid premium and cost sharing requirements, to promote the most effective use of services, and to assist states in identifying cost sharing flexibilities. It includes transition policies for 2014 as applicable.

Lung ultrasound for the diagnosis of pneumonia in adults: a systematic review and meta-analysis

PubMed Central

2014-01-01

Background Guidelines do not currently recommend the use of lung ultrasound (LUS) as an alternative to chest X-ray (CXR) or chest computerized tomography (CT) scan for the diagnosis of pneumonia. We conducted a meta-analysis to summarize existing evidence of the diagnostic accuracy of LUS for pneumonia in adults. Methods We conducted a systematic search of published studies comparing the diagnostic accuracy of LUS against a referent CXR or chest CT scan and/or clinical criteria for pneumonia in adults aged ≥18 years. Eligible studies were required to have a CXR and/or chest CT scan at the time of evaluation. We manually extracted descriptive and quantitative information from eligible studies, and calculated pooled sensitivity and specificity using the Mantel-Haenszel method and pooled positive and negative likelihood ratios (LR) using the DerSimonian-Laird method. We assessed for heterogeneity using the Q and I2 statistics. Results Our initial search strategy yielded 2726 articles, of which 45 (1.7%) were manually selected for review and 10 (0.4%) were eligible for analyses. These 10 studies provided a combined sample size of 1172 participants. Six studies enrolled adult patients who were either hospitalized or admitted to Emergency Departments with suspicion of pneumonia and 4 studies enrolled critically-ill adult patients. LUS was performed by highly-skilled sonographers in seven studies, by trained physicians in two, and one did not mention level of training. All studies were conducted in high-income settings. LUS took a maximum of 13 minutes to conduct. Nine studies used a 3.5-5 MHz micro-convex transducer and one used a 5–9 MHz convex probe. Pooled sensitivity and specificity for the diagnosis of pneumonia using LUS were 94% (95% CI, 92%-96%) and 96% (94%-97%), respectively; pooled positive and negative LRs were 16.8 (7.7-37.0) and 0.07 (0.05-0.10), respectively; and, the area-under-the-ROC curve was 0.99 (0.98-0.99). Conclusions Our meta-analysis supports that LUS, when conducted by highly-skilled sonographers, performs well for the diagnosis of pneumonia. General practitioners and Emergency Medicine physicians should be encouraged to learn LUS since it appears to be an established diagnostic tool in the hands of experienced physicians. PMID:24758612

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.

Identifying patients for clinical trials using fuzzy ternary logic expressions on HL7 messages.

PubMed

Majeed, Raphael W; Röhrig, Rainer

2011-01-01

Identifying eligible patients is one of the most critical parts of any clinical trial. The process of recruiting patients for the third phase of any clinical trial is usually done manually, informing relevant physicians or putting notes on bulletin boards. While most necessary information is already available in electronic hospital information systems, required data still has to be looked up individually. Most university hospitals make use of a dedicated communication server to distribute information from independent information systems, e.g. laboratory information systems, electronic health records, surgery planning systems. Thus, a theoretical model is developed to formally describe inclusion and exclusion criteria for each clinical trial using a fuzzy ternary logic expression. These expressions will then be used to process HL7 messages from a communication server in order to identify eligible patients.

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.

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.

Decision aids that support decisions about prenatal testing for Down syndrome: an environmental scan.

PubMed

Leiva Portocarrero, Maria Esther; Garvelink, Mirjam M; Becerra Perez, Maria Margarita; Giguère, Anik; Robitaille, Hubert; Wilson, Brenda J; Rousseau, François; Légaré, France

2015-09-24

Prenatal screening tests for Down syndrome (DS) are routine in many developed countries and new tests are rapidly becoming available. Decisions about prenatal screening are increasingly complex with each successive test, and pregnant women need information about risks and benefits as well as clarity about their values. Decision aids (DAs) can help healthcare providers support women in this decision. Using an environmental scan, we aimed to identify publicly available DAs focusing on prenatal screening/diagnosis for Down syndrome that provide effective support for decision making. Data sources searched were the Decision Aids Library Inventory (DALI) of the Ottawa Patient Decision Aids Research Group at the Ottawa Health Research Institute; Google searches on the internet; professional organizations, academic institutions and other experts in the field; and references in existing systematic reviews on DAs. Eligible DAs targeted pregnant women, focused on prenatal screening and/or diagnosis, applied to tests for fetal abnormalities or aneuploidies, and were in French, English, Spanish or Portuguese. Pairs of reviewers independently identified eligible DAs and extracted characteristics including the presence of practical decision support tools and features to aid comprehension. They then performed quality assessment using the 16 minimum standards established by the International Patient Decision Aids Standards (IPDASi v4.0). Of 543 potentially eligible DAs (512 in DALI, 27 from experts, and four on the internet), 23 were eligible and 20 were available for data extraction. DAs were developed from 1996 to 2013 in six countries (UK, USA, Canada, Australia, Sweden, and France). Five DAs were for prenatal screening, three for prenatal diagnosis and 12 for both). Eight contained values clarification methods (personal worksheets). The 20 DAs scored a median of 10/16 (range 6-15) on the 16 IPDAS minimum standards. None of the 20 included DAs met all 16 IPDAS minimum standards, and few included practical decision support tools or aids to comprehension. Our results indicate there is a need for DAs that effectively support decision making regarding prenatal testing for Down syndrome, especially in light of the recently available non-invasive prenatal screening tests.

The Invisible Work of Personal Health Information Management Among People With Multiple Chronic Conditions: Qualitative Interview Study Among Patients and Providers

PubMed Central

Witteman, Holly O; Hafeez, Baria; Provencher, Thierry; Van de Graaf, Mary; Wei, Esther

2015-01-01

Background A critical problem for patients with chronic conditions who see multiple health care providers is incomplete or inaccurate information, which can contribute to lack of care coordination, low quality of care, and medical errors. Objective As part of a larger project on applications of consumer health information technology (HIT) and barriers to its use, we conducted a semistructured interview study with patients with multiple chronic conditions (MCC) with the objective of exploring their role in managing their personal health information. Methods Semistructured interviews were conducted with patients and providers. Patients were eligible if they had multiple chronic conditions and were in regular care with one of two medical organizations in New York City; health care providers were eligible if they had experience caring for patients with multiple chronic conditions. Analysis was conducted from a grounded theory perspective, and recruitment was concluded when saturation was achieved. Results A total of 22 patients and 7 providers were interviewed; patients had an average of 3.5 (SD 1.5) chronic conditions and reported having regular relationships with an average of 5 providers. Four major themes arose: (1) Responsibility for managing medical information: some patients perceived information management and sharing as the responsibility of health care providers; others—particularly those who had had bad experiences in the past—took primary responsibility for information sharing; (2) What information should be shared: although privacy concerns did influence some patients’ perceptions of sharing of medical data, decisions about what to share were also heavily influenced by their understanding of health and disease and by the degree to which they understood the health care system; (3) Methods and tools varied: those patients who did take an active role in managing their records used a variety of electronic tools, paper tools, and memory; and (4) Information management as invisible work: managing transfers of medical information to solve problems was a tremendous amount of work that was largely unrecognized by the medical establishment. Conclusions We conclude that personal health information management should be recognized as an additional burden that MCC places upon patients. Effective structural solutions for information sharing, whether institutional ones such as care management or technological ones such as electronic health information exchange, are likely not only to improve the quality of information shared but reduce the burden on patients already weighed down by MCC. PMID:26043709

Subsidized optimal ART for HIV-positive temporary residents of Australia improves virological outcomes: results from the Australian HIV Observational Database Temporary Residents Access Study

PubMed Central

Petoumenos, Kathy; Watson, Jo; Whittaker, Bill; Hoy, Jennifer; Smith, Don; Bastian, Lisa; Finlayson, Robert; Sloane, Andrew; Wright, Stephen T.; McManus, Hamish; Law, Matthew G

2015-01-01

Introduction HIV-positive (HIV+) temporary residents living in Australia legally are unable to access government subsidized antiretroviral treatment (ART) which is provided via Medicare to Australian citizens and permanent residents. Currently, there is no information systematically being collected on non-Medicare eligible HIV+ patients in Australia. The objectives of this study are to describe the population recruited to the Australian HIV Observational Database (AHOD) Temporary Residents Access Study (ATRAS) and to determine the short- and long-term outcomes of receiving (subsidized) optimal ART and the impact on onwards HIV transmission. Methods ATRAS was established in 2011. Eligible patients were recruited via the AHOD network. Key HIV-related characteristics were recorded at baseline and prospectively. Additional visa-related information was also recorded at baseline, and updated annually. Descriptive statistics were used to describe the ATRAS cohort in terms of visa status by key demographic characteristics, including sex, region of birth, and HIV disease status. CD4 cell count (mean and SD) and the proportion with undetectable (<50 copies/ml) HIV viral load are reported at baseline, 6 and 12 months of follow-up. We also estimate the proportion reduction of onward HIV transmission based on the reduction in proportion of people with detectable HIV viral load. Results A total of 180 patients were recruited to ATRAS by June 2012, and by July 2013 39 patients no longer required ART via ATRAS, 35 of whom became eligible for Medicare-funded medication. At enrolment, 63% of ATRAS patients were receiving ART from alternative sources, 47% had an undetectable HIV viral load (<50 copies/ml) and the median CD4 cell count was 343 cells/µl (IQR: 222–479). At 12 months of follow-up, 85% had an undetectable viral load. We estimated a 75% reduction in the risk of onward HIV transmission with the improved rate of undetectable viral load. Conclusions The immunological and virological improvements highlight the importance of supplying optimal ART to this vulnerable population. The increase in proportion with undetectable HIV viral load shows the potentially significant impact on HIV transmission in addition to the personal health benefit for each individual. PMID:25680919

77 FR 52614 - Pre-Existing Condition Insurance Plan Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-30

...This document contains an amendment regarding program eligibility to the interim final regulation implementing the Pre- Existing Condition Plan program under provisions of the Patient Protection and Affordable Care Act. In light of a new process recently announced by the Department of Homeland Security, eligibility for the program is being amended so that the program does not inadvertently expand the scope of that process.

Memory assessment in patients with temporal lobe epilepsy to predict memory impairment after surgery: A systematic review.

PubMed

Parra-Díaz, P; García-Casares, N

2017-04-19

Given that surgical treatment of refractory mesial temporal lobe epilepsy may cause memory impairment, determining which patients are eligible for surgery is essential. However, there is little agreement on which presurgical memory assessment methods are best able to predict memory outcome after surgery and identify those patients with a greater risk of surgery-induced memory decline. We conducted a systematic literature review to determine which presurgical memory assessment methods best predict memory outcome. The literature search of PubMed gathered articles published between January 2005 and December 2015 addressing pre- and postsurgical memory assessment in mesial temporal lobe epilepsy patients by means of neuropsychological testing, functional MRI, and other neuroimaging techniques. We obtained 178 articles, 31 of which were included in our review. Most of the studies used neuropsychological tests and fMRI; these methods are considered to have the greatest predictive ability for memory impairment. Other less frequently used techniques included the Wada test and FDG-PET. Current evidence supports performing a presurgical assessment of memory function using both neuropsychological tests and functional MRI to predict memory outcome after surgery. Copyright © 2017 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

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.

Description and Validation of TAVIApp: A Novel Mobile Application for Support of Physicians in the Management of Aortic Stenosis—Management of Aortic Stenosis with TAVIApp

PubMed Central

Sabatino, Jolanda; Mongiardo, Annalisa; Ricci, Pietrantonio; Spaccarotella, Carmen

2017-01-01

Background Aortic stenosis (AS) is the most common heart valve disease in developed countries. The advent of transcatheter aortic valve implantation (TAVI) significantly improved patients' outcome but made clinical management more complex. The aim of the present study was to describe TAVIApp, a mobile app we developed to guide the management of AS, and test its efficacy. Methods and Results Clinical cases comprising 42 patients with AS were blindly evaluated by (A) an interventional cardiologist, assisted by the Heart Team (EXPERT), (B) young residents in cardiology, and (C) a young resident supported by TAVIApp. There was poor concordance between Group A and Group B with low performance by young residents (k = 0.52; p < 0.001). However, concordance increased to an optimal value when young residents were supported by TAVIApp (k = 1.0; p < 0.001) for the diagnosis of severe AS and eligibility assessment. Furthermore, regarding the selection of the most appropriate prosthesis size, concordance to Group A was poor without TAVIApp support (Group B) (k = 0.78; p = 0.430), but excellent with TAVIApp (k = 1.0; p < 0.001). Conclusions This study is the first describing and validating a new mobile application to support the management of AS. TAVIApp supports cardiologists in the evaluation of stenosis severity, eligibility for TAVI or AVR, and selection of the most appropriate prosthesis size in individual patients. PMID:29270437

Adherence to Vaginal Dilation Following High Dose Rate Brachytherapy for Endometrial Cancer

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

Friedman, Lois C., E-mail: Lois.Friedman@UHhospitals.org; Abdallah, Rita; Schluchter, Mark

Purpose: We report demographic, clinical, and psychosocial factors associated with adherence to vaginal dilation and describe the sexual and marital or nonmarital dyadic functioning of women following high dose rate (HDR) brachytherapy for endometrial cancer. Methods and Materials: We retrospectively evaluated women aged 18 years or older in whom early-stage endometrial (IAgr3-IIB) cancers were treated by HDR intravaginal brachytherapy within the past 3.5 years. Women with or without a sexual partner were eligible. Patients completed questionnaires by mail or by telephone assessing demographic and clinical variables, adherence to vaginal dilation, dyadic satisfaction, sexual functioning, and health beliefs. Results: Seventy-eight ofmore » 89 (88%) eligible women with early-stage endometrial cancer treated with HDR brachytherapy completed questionnaires. Only 33% of patients were adherers, based on reporting having used a dilator more than two times per week in the first month following radiation. Nonadherers who reported a perceived change in vaginal dimension following radiation reported that their vaginas were subjectively smaller after brachytherapy (p = 0.013). Adherers reported more worry about their sex lives or lack thereof than nonadherers (p = 0.047). Patients reported considerable sexual dysfunction following completion of HDR brachytherapy. Conclusions: Adherence to recommendations for vaginal dilator use following HDR brachytherapy for endometrial cancer is poor. Interventions designed to educate women about dilator use benefit may increase adherence. Although sexual functioning was compromised, it is likely that this existed before having cancer for many women in our study.« less

Differential effect of age on survival in advanced NSCLC in women versus men: Analysis of recent Eastern Cooperative Oncology Group (ECOG) studies, with and without bevacizumab

PubMed Central

Wakelee, H.A.; Dahlberg, S.E.; Brahmer, J.R.; Schiller, J.H.; Perry, M.C.; Langer, C.J.; Sandler, A.B.; Belani, C.P.; Johnson, D.H.

2012-01-01

Background The impact of age on prognosis in advanced stage non-small cell lung cancer (NSCLC) may differ by sex. Patients and methods Eligible patients (N = 1590) from E1594, a 4-arm platinum-based chemotherapy trial, and E4599 (carboplatin/paclitaxel ± bevacizumab) chemotherapy arm were divided into male and female cohorts and separated into age groups of <60 or ≥60 years old. Eligible E4599 patients (N = 850) were similarly separated by age and sex and by treatment (±bevacizumab). Survival was calculated separately for each cohort. Results The median survival time (MST) for women ≥60 years old treated with chemotherapy alone on E1594 and E4599 was 11.6 months versus 9.0 months for women <60 (p = 0.03). MST was 7.4 and 8.3 months for men ≥60 and <60 years old respectively (NS). In E4599 the age <60 by bevacizumab treatment interaction was statistically significant (p = 0.03) for women (younger had greater benefit), with no age effect in men. Conclusions In this unplanned, exploratory subgroup analysis of advanced stage NSCLC ECOG trials, women ≥60 years old treated with chemotherapy live longer than men and younger women. In contrast, bevacizumab survival benefit was more pronounced in men of any age and in younger women on E4599. PMID:22266041

Intrinsic factors influencing help-seeking behaviour in an acute stroke situation.

PubMed

Zock, Elles; Kerkhoff, Henk; Kleyweg, Ruud Peter; van de Beek, Diederik

2016-09-01

The proportion of stroke patients eligible for intravenous or intra-arterial treatment is still limited because many patients do not seek medical help immediately after stroke onset. The aim of our study was to explore which intrinsic factors and considerations influence help-seeking behaviour of relatively healthy participants, confronted with stroke situations. Semi-structured interviews were conducted with 25 non-stroke participants aged 50 years or older. We presented 5 clinical stroke situations as if experienced by the participants themselves. Recognition and interpretation of symptoms were evaluated and various factors influencing help-seeking behaviour were explored in-depth. We used the thematic synthesis method for data analysis. Five themes influencing help-seeking behaviour in a stroke situation were identified: influence of knowledge, views about seriousness, ideas about illness and health, attitudes towards others and beliefs about the emergency medical system. A correct recognition of stroke symptoms or a correct interpretation of the stroke situations did not automatically result in seeking medical help. Interestingly, similar factors could lead to different types of actions between participants. Many intrinsic, as well as social and environmental factors are of influence on help-seeking behaviour in an acute stroke situation. All these factors seem to play a complex role in help-seeking behaviour with considerable inter-individual variations. Accomplishing more patients eligible for acute stroke treatment, future research should focus on better understanding of all factors at various levels grounded in a theory of help-seeking behaviour.

Impact of passive and active promotional strategies on patient acceptance of medication therapy management services.

PubMed

Huet, Alison L; Frail, Caitlin K; Lake, Leslie M; Snyder, Margie E

2015-01-01

To assess the impact of passive and active promotional strategies on patient acceptance of medication therapy management (MTM) services, and to identify reasons for patient acceptance or refusal. Four promotional approaches were developed to offer MTM services to eligible patients, including letters and bag stuffers ("passive" approaches), and face-to-face offers and telephone calls ("active" approaches). Thirty pharmacies in a grocery store chain were randomized to one of the four approaches. Patient acceptance rates were compared among the four groups, and between active and passive approaches using hierarchical logistic regression techniques. Depending on their decision to accept or decline the service, patients were invited to take part in one of two brief telephone surveys. No significant differences were identified among the four promotional methods or between active and passive methods in the analyses. Patients' most frequent reasons for accepting MTM services were potential cost savings, review of how the medications were working, the expert opinion of the pharmacist, and education about medications. Patients' most frequent reasons for declining MTM services were that the participant already felt comfortable with their medications and felt their pharmacist provides these services on a regular basis. No significant difference was found among any of the four groups or between active or passive approaches. Further research is warranted to identify strategies for improving patient engagement in MTM services.

Role of Alternative Donor Allogeneic Transplants in the Therapy of Acute Myeloid Leukemia.

PubMed

Elmariah, Hany; Pratz, Keith W

2017-07-01

Adult acute myeloid leukemia (AML) is often associated with a poor prognosis, with allogeneic transplantation representing the greatest chance of cure for eligible patients. Historically, the preferred donor source is a human leukocyte antigen-matched blood relative, although only approximately 30% of patients have access to such a donor. Alternative donor sources, including matched unrelated donors, umbilical cord blood, and haploidentical related donors, are available for almost every patient and are increasingly being used for patients without a matched related donor. Survival outcomes with these alternative donor sources now approximate those of matched related donor transplants. Given the safety and success of alternative donor transplants, comparative trials are needed to reassess the optimal donor source for patients with AML. This review summarizes the available data on these alternative donor transplants. Further investigation is needed to contemporize donor selection algorithms, but, in the current era, donor availability should no longer preclude a patient's eligibility for an allogeneic blood or marrow transplant. Copyright © 2017 by the National Comprehensive Cancer Network.

Female fertility following dose-adjusted EPOCH-R chemotherapy in primary mediastinal B-cell lymphomas.

PubMed

Gharwan, Helen; Lai, Catherine; Grant, Cliona; Dunleavy, Kieron; Steinberg, Seth M; Shovlin, Margaret; Fojo, Tito; Wilson, Wyndham H

2016-07-01

We assessed fertility/gonadal function in premenopausal women treated with dose-adjusted EPOCH-Rituximab for untreated primary mediastinal B-cell lymphoma (PMBL). Eligible patents were ≤ 50 years and premenopausal. Serial reproductive histories were obtained and hormonal assays were performed on serum samples before, at the end of treatment and 4-18 months later. Twenty-eight eligible women had a median age (range) of 31 (21-50) years and were followed a median of 7.3 years. Of 23 patients who completed a questionnaire, 19 (83%) were and four were not menstruating prior to chemotherapy. Amenorrhea developed in 12 patients during chemotherapy. At > 1-year follow-up, 14/19 (74%) patients were menstruating, all < 35 years old, and six (43%) of these patients delivered healthy children. Hormonal assays showed ovarian dysfunction during chemotherapy in all patients with varying recovery at 4-18 months after treatment. Fertility was preserved in most women with ovarian failure confined to patients > 40 years old.

Low rates of hepatitis A and B vaccination in patients with chronic hepatitis C at an urban methadone maintenance program.

PubMed

Felsen, Uriel R; Fishbein, Dawn A; Litwin, Alain H

2010-10-01

Patients with chronic hepatitis C virus (HCV) are at increased risk for complications of liver disease if they become infected with the hepatitis A (HAV) or hepatitis B (HBV) viruses. The authors examined the rates of testing for HAV, HBV, and HCV, as well as rates of vaccination against HAV and HBV in patients with chronic HCV in a random sample (N = 207) of medical records of patients enrolled in a methadone maintenance program. Almost all patients reviewed were tested for HAV, HBV, and HCV. Of the 111 patients with chronic HCV, 53 (48.6%) and 68 (63%) lacked immunity to HAV and HBV, respectively. Of those lacking immunity, 29 (54.7%) and 2 (2.9%) were vaccinated for HAV and HBV, respectively. Despite high rates of testing for HAV, HBV, and HCV at a methadone maintenance program, approximately half of those with chronic HCV eligible for the HAV vaccine received it, and few of those eligible for HBV vaccine received it.

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.

Randomized Multicenter Feasibility Trial of Myofascial Physical Therapy for Treatment of Urologic Chronic Pelvic Pain Syndrome

PubMed Central

FitzGerald, Mary P; Anderson, Rodney U; Potts, Jeannette; Payne, Christopher K; Peters, Kenneth M; Clemens, J Quentin; Kotarinos, Rhonda; Fraser, Laura; Cosby, Annamarie; Fortman, Carole; Neville, Cynthia; Badillo, Suzanne; Odabachian, Lisa; Sanfield, Anna; O’Dougherty, Betsy; Halle-Podell, Rick; Cen, Liyi; Chuai, Shannon; Landis, J Richard; Kusek, John W; Nyberg, Leroy M

2010-01-01

Objectives To determine the feasibility of conducting a randomized clinical trial designed to compare two methods of manual therapy (myofascial physical therapy (MPT) and global therapeutic massage (GTM)) among patients with urologic chronic pelvic pain syndromes. Materials and Methods Our goal was to recruit 48 subjects with chronic prostatitis/chronic pelvic pain syndrome or interstitial cystitis/painful bladder syndrome at six clinical centers. Eligible patients were randomized to either MPT or GTM and were scheduled to receive up to 10 weekly treatments, each 1 hour in duration. Criteria to assess feasibility included adherence of therapists to prescribed therapeutic protocol as determined by records of treatment, adverse events which occurred during study treatment, and rate of response to therapy as assessed by the Patient Global Response Assessment (GRA). Primary outcome analysis compared response rates between treatment arms using Mantel-Haenszel methods. Results Twenty-three (49%) men and 24 (51%) women were randomized over a six month period. Twenty-four (51%) patients were randomized to GTM, 23 (49%) to MPT; 44 (94%) patients completed the study. Therapist adherence to the treatment protocols was excellent. The GRA response rate of 57% in the MPT group was significantly higher than the rate of 21% in the GTM treatment group (p=0.03). Conclusions The goals to judge feasibility of conducting a full-scale trial of physical therapy methods were met. The preliminary findings of a beneficial effect of MPT warrants further study. PMID:19535099

Which patients are not included in the English Cancer Waiting Times monitoring dataset, 2009–2013? Implications for use of the data in research

PubMed Central

Di Girolamo, C; Walters, S; Gildea, C; Benitez Majano, S; Coleman, M P; Rachet, B; Morris, M

2018-01-01

Background: Cancer waiting time targets are routinely monitored in England, but the Cancer Waiting Times monitoring dataset (CWT) does not include all eligible patients, introducing scope for bias. Methods: Data from adults diagnosed in England (2009–2013) with colorectal, lung, or ovarian cancer were linked from CWT to cancer registry, mortality, and Hospital Episode Statistics data. We present demographic characteristics and net survival for patients who were and were not included in CWT. Results: A CWT record was found for 82% of colorectal, 76% of lung, and 77% of ovarian cancer patients. Patients not recorded in CWT were more likely to be in the youngest or oldest age groups, have more comorbidities, have been diagnosed through emergency presentation, have late or missing stage, and have much poorer survival. Conclusions: Researchers and policy-makers should be aware of the limitations in the completeness and representativeness of CWT, and draw conclusions with appropriate caution. PMID:29348489

Enhanced identification of eligibility for depression research using an electronic medical record search engine.

PubMed

Seyfried, Lisa; Hanauer, David A; Nease, Donald; Albeiruti, Rashad; Kavanagh, Janet; Kales, Helen C

2009-12-01

Electronic medical records (EMRs) have become part of daily practice for many physicians. Attempts have been made to apply electronic search engine technology to speed EMR review. This was a prospective, observational study to compare the speed and clinical accuracy of a medical record search engine vs. manual review of the EMR. Three raters reviewed 49 cases in the EMR to screen for eligibility in a depression study using the electronic medical record search engine (EMERSE). One week later raters received a scrambled set of the same patients including 9 distractor cases, and used manual EMR review to determine eligibility. For both methods, accuracy was assessed for the original 49 cases by comparison with a gold standard rater. Use of EMERSE resulted in considerable time savings; chart reviews using EMERSE were significantly faster than traditional manual review (p=0.03). The percent agreement of raters with the gold standard (e.g. concurrent validity) using either EMERSE or manual review was not significantly different. Using a search engine optimized for finding clinical information in the free-text sections of the EMR can provide significant time savings while preserving clinical accuracy. The major power of this search engine is not from a more advanced and sophisticated search algorithm, but rather from a user interface designed explicitly to help users search the entire medical record in a way that protects health information.

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.

Indicators of patients with major depressive disorder in need of highly specialized care: A systematic review

PubMed Central

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

Objectives 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. Methods 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. Results 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. Conclusions 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. PMID:28178306

Depth of Response in Multiple Myeloma: A Pooled Analysis of Three PETHEMA/GEM Clinical Trials

PubMed Central

Vidriales, Maria-Belen; Cordón, Lourdes; Cedena, Maria-Teresa; Puig, Noemi; Martinez-Lopez, Joaquin; Rosiñol, Laura; Gutierrez, Norma C.; Martín-Ramos, María-Luisa; Oriol, Albert; Teruel, Ana-Isabel; Echeveste, María-Asunción; de Paz, Raquel; de Arriba, Felipe; Hernandez, Miguel T.; Palomera, Luis; Martinez, Rafael; Martin, Alejandro; Alegre, Adrian; De la Rubia, Javier; Orfao, Alberto; Mateos, María-Victoria; Blade, Joan; San-Miguel, Jesus F.

2017-01-01

Purpose To perform a critical analysis on the impact of depth of response in newly diagnosed multiple myeloma (MM). Patients and Methods Data were analyzed from 609 patients who were enrolled in the GEM (Grupo Español de Mieloma) 2000 and GEM2005MENOS65 studies for transplant-eligible MM and the GEM2010MAS65 clinical trial for elderly patients with MM who had minimal residual disease (MRD) assessments 9 months after study enrollment. Median follow-up of the series was 71 months. Results Achievement of complete remission (CR) in the absence of MRD negativity was not associated with prolonged progression-free survival (PFS) and overall survival (OS) compared with near-CR or partial response (median PFS, 27, 27, and 29 months, respectively; median OS, 59, 64, and 65 months, respectively). MRD-negative status was strongly associated with prolonged PFS (median, 63 months; P < .001) and OS (median not reached; P < .001) overall and in subgroups defined by prior transplantation, disease stage, and cytogenetics, with prognostic superiority of MRD negativity versus CR particularly evident in patients with high-risk cytogenetics. Accordingly, Harrell C statistics showed higher discrimination for both PFS and OS in Cox models that included MRD (as opposed to CR) for response assessment. Superior MRD-negative rates after different induction regimens anticipated prolonged PFS. Among 34 MRD-negative patients with MM and a phenotypic pattern of bone marrow involvement similar to monoclonal gammopathy of undetermined significance at diagnosis, the probability of “operational cure” was high; median PFS was 12 years, and the 10-year OS rate was 94%. Conclusion Our results demonstrate that MRD-negative status surpasses the prognostic value of CR achievement for PFS and OS across the disease spectrum, regardless of the type of treatment or patient risk group. MRD negativity should be considered as one of the most relevant end points for transplant-eligible and elderly fit patients with MM. PMID:28498784

Depth of Response in Multiple Myeloma: A Pooled Analysis of Three PETHEMA/GEM Clinical Trials.

PubMed

Lahuerta, Juan-Jose; Paiva, Bruno; Vidriales, Maria-Belen; Cordón, Lourdes; Cedena, Maria-Teresa; Puig, Noemi; Martinez-Lopez, Joaquin; Rosiñol, Laura; Gutierrez, Norma C; Martín-Ramos, María-Luisa; Oriol, Albert; Teruel, Ana-Isabel; Echeveste, María-Asunción; de Paz, Raquel; de Arriba, Felipe; Hernandez, Miguel T; Palomera, Luis; Martinez, Rafael; Martin, Alejandro; Alegre, Adrian; De la Rubia, Javier; Orfao, Alberto; Mateos, María-Victoria; Blade, Joan; San-Miguel, Jesus F

2017-09-01

Purpose To perform a critical analysis on the impact of depth of response in newly diagnosed multiple myeloma (MM). Patients and Methods Data were analyzed from 609 patients who were enrolled in the GEM (Grupo Español de Mieloma) 2000 and GEM2005MENOS65 studies for transplant-eligible MM and the GEM2010MAS65 clinical trial for elderly patients with MM who had minimal residual disease (MRD) assessments 9 months after study enrollment. Median follow-up of the series was 71 months. Results Achievement of complete remission (CR) in the absence of MRD negativity was not associated with prolonged progression-free survival (PFS) and overall survival (OS) compared with near-CR or partial response (median PFS, 27, 27, and 29 months, respectively; median OS, 59, 64, and 65 months, respectively). MRD-negative status was strongly associated with prolonged PFS (median, 63 months; P < .001) and OS (median not reached; P < .001) overall and in subgroups defined by prior transplantation, disease stage, and cytogenetics, with prognostic superiority of MRD negativity versus CR particularly evident in patients with high-risk cytogenetics. Accordingly, Harrell C statistics showed higher discrimination for both PFS and OS in Cox models that included MRD (as opposed to CR) for response assessment. Superior MRD-negative rates after different induction regimens anticipated prolonged PFS. Among 34 MRD-negative patients with MM and a phenotypic pattern of bone marrow involvement similar to monoclonal gammopathy of undetermined significance at diagnosis, the probability of "operational cure" was high; median PFS was 12 years, and the 10-year OS rate was 94%. Conclusion Our results demonstrate that MRD-negative status surpasses the prognostic value of CR achievement for PFS and OS across the disease spectrum, regardless of the type of treatment or patient risk group. MRD negativity should be considered as one of the most relevant end points for transplant-eligible and elderly fit patients with MM.

Clinician Suspicion of an Alcohol Problem: An Observational Study From the AAFP National Research Network

PubMed Central

Vinson, Daniel C.; Turner, Barbara J.; MSED; Manning, Brian K.; Galliher, James M.

2013-01-01

PURPOSE In clinical practice, detection of alcohol problems often relies on clinician suspicion instead of using a screening instrument. We assessed the sensitivity, specificity, and predictive values of clinician suspicion compared with screening-detected alcohol problems in patients. METHODS We undertook a cross-sectional study of 94 primary care clinicians’ office visits. Brief questionnaires were completed separately after a visit by both clinicians and eligible patients. The patient’s anonymous exit questionnaire screened for hazardous drinking based on the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) and for harmful drinking (alcohol abuse or dependence) based on 2 questions from the Diagnostic and Statistical Manual of Mental Disorders. After the visit, clinicians responded to the question, “Does this patient have problems with alcohol?” with answer options including “yes, hazardous drinking” and “yes, alcohol abuse or dependence.” Analyses assessed the associations between patients’ responses to screening questions and clinician’s suspicions. RESULTS Of 2,518 patients with an office visit, 2,173 were eligible, and 1,699 (78%) completed the exit questionnaire. One hundred seventy-one (10.1%) patients had a positive screening test for hazardous drinking (an AUDIT-C score of 5 or greater) and 64 (3.8%) for harmful drinking. Clinicians suspected alcohol problems in 81 patients (hazardous drinking in 37, harmful drinking in 40, and both in 4). The sensitivity of clinician suspicion of either hazardous or harmful drinking was 27% and the specificity was 98%. Positive and negative predictive values were 62% and 92%, respectively. CONCLUSION Clinician suspicion of alcohol problems had poor sensitivity but high specificity for identifying patients who had a positive screening test for alcohol problems. These data support the routine use of a screening tool to supplement clinicians’ suspicions, which already provide reasonable positive predictive value. PMID:23319506

Refractive errors among patients attending the ophthalmology department of a medical college in North-East India

PubMed Central

Natung, Tanie; Taye, Trishna; Lyngdoh, Laura Amanda; Dkhar, Begonia; Hajong, Ranendra

2017-01-01

Purpose: To determine the magnitude and pattern of refractive errors among patients attending the ophthalmology department of a new medical college in North-East India. Materials and Methods: A prospective study of the new patients (age ≥5 years), who were phakic and whose unaided visual acuities were worse than 20/20 but improved with pinhole, was done. Complete ophthalmic examination and refraction with appropriate cycloplegia for age were done for the 4582 eligible patients. Spherical equivalents (SE) of refractive errors of the right eyes were used for analysis. Results: Of the 4582 eligible patients, 2546 patients had refractive errors (55.56%). The proportion of emmetropia (SE − 0.50–+0.50 diopter sphere [DS]), myopia (SE <−0.50 DS), high myopia (SE >−5.0 DS), and hypermetropia (>+0.50 DS for adults and >+2.0 DS for children) were 53.1%, 27.4%, 2.6%, and 16.9%, respectively. The proportion of hyperopia increased till 59 years and then decreased with age (P = 0.000). The proportion of myopia and high myopia decreased significantly with age after 39 years (P = 0.000 and P = 0.004, respectively). Of the 1510 patients with astigmatism, 17% had with-the-rule (WTR), 23.4% had against-the-rule (ATR), and 19% had oblique astigmatisms. The proportion of WTR and ATR astigmatisms significantly decreased (P = 0.000) and increased (P = 0.000) with age, respectively. Conclusions: This study has provided the magnitude and pattern of refractive errors in the study population. It will serve as the initial step for conducting community-based studies on the prevalence of refractive errors in this part of the country since such data are lacking from this region. Moreover, this study will help the primary care physicians to have an overview of the magnitude and pattern of refractive errors presenting to a health-care center as refractive error is an established and significant public health problem worldwide. PMID:29417005

What do Clinicians Derive from Partnering with their Patients?: A Reliable and Valid Measure of “Personal Meaning in Patient Care”

PubMed Central

Geller, Gail; Bernhardt, Barbara A.; Carrese, Joseph; Rushton, Cynda H.; Kolodner, Ken

2008-01-01

Objective Burnout is high among clinicians and may relate to loss of “meaning” in patient care. We sought to develop and validate a measure of “personal meaning” that practitioners derive from patient care. Methods As part of a larger study of well-being among genetics professionals, we conducted three focus groups of clinical genetics professionals: physicians, nurses and genetic counselors (N=29). Participants were asked: “What gives you meaning in patient care?” Eight themes were identified, converted into Likert items, and included in a questionnaire. Next, we mailed the questionnaire to clinical geneticists, genetic counselors and genetic nurses (N=480) randomly selected from mailing lists of their professional associations. Results were subjected to exploratory factor analysis. The survey also included validated scales of burnout and professional satisfaction, and a one-item measure of gratitude, to assess predictive validity. Results 214 eligible providers completed the survey out of an estimated 348 eligible (61% response rate). Factor analysis resulted in a unidimensional scale consisting of 6-items with an alpha of .82 and an eigen value of 3.2. Factor loadings ranged from .69–.77. The mean total score was 18.1 (SD 3.7) out of a possible high score of 24. Higher meaning scores were associated with being female (p=.044), a nurse (p<.001), and in practice longer (p=.006). Meaning scores were inversely correlated with burnout (p<.001), and positively correlated with gratitude (p<.001) and professional satisfaction (p<.022). Conclusion The 6-item “personal meaning in patient care” scale demonstrates high reliability and predictive validity in a select group of health professionals. Future research should validate this scale in a broader population of clinicians. Practice Implications The scale could be useful in identifying providers at risk of burnout, and in evaluating interventions designed to counteract burnout, enhance meaning and improve communication and partnership between providers and patients. PMID:18485656

Phase III Comparison of Prophylactic Cranial Irradiation Versus Observation in Patients With Locally Advanced Non–Small-Cell Lung Cancer: Primary Analysis of Radiation Therapy Oncology Group Study RTOG 0214

PubMed Central

Gore, Elizabeth M.; Bae, Kyounghwa; Wong, Stuart J.; Sun, Alexander; Bonner, James A.; Schild, Steven E.; Gaspar, Laurie E.; Bogart, Jeffery A.; Werner-Wasik, Maria; Choy, Hak

2011-01-01

Purpose This study was conducted to determine if prophylactic cranial irradiation (PCI) improves survival in locally advanced non–small-cell lung cancer (LA-NSCLC). Patients and Methods Patients with stage III NSCLC without disease progression after treatment with surgery and/or radiation therapy (RT) with or without chemotherapy were eligible. Participants were stratified by stage (IIIA v IIIB), histology (nonsquamous v squamous), and therapy (surgery v none) and were randomly assigned to PCI or observation. PCI was delivered to 30 Gy in 15 fractions. The primary end point of the study was overall survival (OS). Secondary end points were disease-free survival (DFS), neurocognitive function (NCF), and quality of life. Kaplan-Meier and log-rank analyses were used for OS and DFS. The incidence of brain metastasis (BM) was evaluated with the logistic regression model. Results Overall, 356 patients were accrued of the targeted 1,058. The study was closed early because of slow accrual; 340 of the 356 patients were eligible. The 1-year OS (P = .86; 75.6% v 76.9% for PCI v observation) and 1-year DFS (P = .11; 56.4% v 51.2% for PCI v observation) were not significantly different. The hazard ratio for observation versus PCI was 1.03 (95% CI, 0.77 to 1.36). The 1-year rates of BM were significantly different (P = .004; 7.7% v 18.0% for PCI v observation). Patients in the observation arm were 2.52 times more likely to develop BM than those in the PCI arm (unadjusted odds ratio, 2.52; 95% CI, 1.32 to 4.80). Conclusion In patients with stage III disease without progression of disease after therapy, PCI decreased the rate of BM but did not improve OS or DFS. PMID:21135270

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.

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.

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.

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.

Evaluating a systematic voiding programme for patients with urinary incontinence after stroke in secondary care using soft systems analysis and Normalisation Process Theory: findings from the ICONS case study phase.

PubMed

Thomas, L H; French, B; Burton, C R; Sutton, C; Forshaw, D; Dickinson, H; Leathley, M J; Britt, D; Roe, B; Cheater, F M; Booth, J; Watkins, C L

2014-10-01

Urinary incontinence (UI) affects between 40 and 60% of people in hospital after stroke, but is often poorly managed in stroke units. To inform an exploratory trial by three methods: identifying the organisational context for embedding the SVP; exploring health professionals' views around embedding the SVP and measuring presence/absence of UI and frequency of UI episodes at baseline and six weeks post-stroke. A mixed methods single case study included analysis of organisational context using interviews with clinical leaders analysed with soft systems methodology, a process evaluation using interviews with staff delivering the intervention and analysed with Normalisation Process Theory, and outcome evaluation using data from patients receiving the SVP and analysed using descriptive statistics. An 18 bed acute stroke unit in a large Foundation Trust (a 'not for profit' privately controlled entity not accountable to the UK Department of Health) serving a population of 370,000. Health professionals and clinical leaders with a role in either delivering the SVP or linking with it in any capacity were recruited following informed consent. Patients were recruited meeting the following inclusion criteria: aged 18 or over with a diagnosis of stroke; urinary incontinence (UI) as defined by the International Continence Society; conscious; medically stable as judged by the clinical team and with incontinence classified as stress, urge, mixed or 'functional'. All patients admitted to the unit during the intervention period were screened for eligibility; informed consent to collect baseline and outcome data was sought from all eligible patients. Organisational context: 18 health professionals took part in four group interviews. Findings suggest an environment not conducive to therapeutic continence management and a focus on containment of UI. Embedding the SVP into practice: 21 nursing staff took part in six group interviews. Initial confusion gave way to embedding of processes facilitated by new routines and procedures. Patient outcome: 43 patients were recruited; 28 of these commenced the SVP. Of these, 6/28 (21%) were continent at six weeks post-stroke or discharge. It was possible to embed the SVP into practice despite an organisational context not conducive to therapeutic continence care. Recommendations are made for introducing the SVP in a trial context. Copyright © 2014. Published by Elsevier Ltd.

An extension in eligibility for free primary care and avoidable hospitalisations: a natural experiment.

PubMed

Nolan, Anne

2011-10-01

In the Republic of Ireland, approximately 30 per cent of the population ('medical card patients') are entitled to free GP services. Eligibility is determined primarily on the basis of an income means test. The remaining 70 per cent of the population ('private patients') must pay the full cost of GP consultations. In July 2001, eligibility for a medical card was extended to all those over 70 years of age, regardless of income. This extension in eligibility provides a natural experiment whereby we can examine the influence of access to free GP services on avoidable hospitalisations. Avoidable hospitalisations are those that are potentially avoidable with timely and effective access to primary care services or that can be treated more appropriately in a primary care setting. Using hospital discharge data for the period 1999-2004, the purpose of this paper is to test the proposition that enhanced access to GP services for the over 70s after July 2001 led to a decline in avoidable hospitalisations among this group. The results indicate that while avoidable hospitalisations for the over 70s did decline after 2001, they also fell for the under 70s, meaning that a significant difference-in-difference effect could not be identified. Copyright © 2011 Elsevier Ltd. All rights reserved.

[Benefit Assessment for Examination and Treatment Methods with Medical Devices of High Hisk: Trade-off between Patient Benefit, Evidence and Access].

PubMed

Mühlbacher, Axel C; Juhnke, Christin

2018-03-01

The lately inured § 137 h SGB V aims to assess the benefit of new examination and treatment methods with medical devices of class IIb and III. In the future, the decision on the reimbursement eligibility will be marked by high requirements in terms of documentation of benefits and harm. The objective of benefit assessment is the operationalization of benefit to patients. A comparative determination of benefit enables rational decision by regulatory authorities. The process of benefit assessment should guarantee transparent decision-making, and the underlying medical and health economic fundamentals should be documented. In principle, benefit assessment can be divided into 3 phases: measuring causal effects of an intervention, assessment of the measured effects and decision on reimbursement based on the aggregation of an overall benefit. To address the peculiarities of medical devices in this process, adaptive study designs, MCDA and adaptive benefit assessment provide a sustainable concept for rapid access by patients to innovative treatments of high quality and safety. © Georg Thieme Verlag KG Stuttgart · New York.

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.

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.

Measures of rheumatoid arthritis disease activity in Australian clinical practice.

PubMed

Taylor, Andrew; Bagga, Hanish

2011-01-01

Objectives. To investigate which rheumatoid arthritis (RA) disease activity measures are being collected in patients receiving glucocorticoids, non-biologic or biologic disease-modifying antirheumatic drugs (DMARDs) in Australian rheumatology practice. Methods. A retrospective audit of medical records was conducted from eight rheumatology practices around Australia. Each rheumatologist recruited 30 consecutive eligible patients into the review, 10 of whom must have been receiving a biological agent for rheumatoid arthritis. Disease activity measures and radiographic assessments were collected from each patient's last consultation. For biologic patients, disease activity measures were also collected from when the patient was first initiated on the biological agent. Results. At last consultation, the disease measures that were recorded most often were ESR (89.2%), haemoglobin (87.5%), and CRP (84.2%). DAS28 was infrequently recorded (16.3%). The rate of recording disease activity measures for patients receiving biologic DMARDs decreased over time (mean 27 months). Conclusion. This review has shown inconsistency of RA activity measures being recorded in Australian rheumatology clinical practice. An accurate assessment of the disease process is necessary to effectively target rheumatoid arthritis patients to treat in order to achieve optimal outcomes.

Gait Retraining With Real-Time Biofeedback to Reduce Knee Adduction Moment: Systematic Review of Effects and Methods Used.

PubMed

Richards, Rosie; van den Noort, Josien C; Dekker, Joost; Harlaar, Jaap

2017-01-01

To review the current literature regarding methods and effects of real-time biofeedback used as a method for gait retraining to reduce knee adduction moment (KAM), with intended application for patients with knee osteoarthritis (KOA). Searches were conducted in MEDLINE, Embase, CINAHL, SPORTDiscus, Web of Science, and Cochrane Central Register of Controlled Trials with the keywords gait, feedback, and knee osteoarthritis from inception to May 2015. Titles and abstracts were screened by 1 individual for studies aiming to reduce KAM. Full-text articles were assessed by 2 individuals against predefined criteria. Data were extracted by 1 individual according to a predefined list, including participant demographics and training methods and effects. Electronic searches resulted in 190 potentially eligible studies, from which 12 met all inclusion criteria. Within-group standardized mean differences (SMDs) for reduction of KAM in healthy controls ranged from .44 to 2.47 and from .29 to .37 in patients with KOA. In patients with KOA, improvements were reported in pain and function, with SMDs ranging from .55 to 1.16. Methods of implementation of biofeedback training varied between studies, but in healthy controls increased KAM reduction was noted with implicit, rather than explicit, instructions. This review suggests that biofeedback gait training is effective primarily for reducing KAM but also for reducing pain and improving function in patients with KOA. The review was limited by the small number of studies featuring patients with KOA and the lack of controlled studies. The results suggest there is value and a need in further researching biofeedback training for reducing KAM. Future studies should include larger cohorts of patients, long-term follow-up, and controlled trials. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Engaging patients via mobile phone technology to assist follow-up after hospitalization in Quito, Ecuador.

PubMed

Maslowsky, Julie; Valsangkar, Bina; Chung, Jennifer; Rasanathan, Jennifer; Cruz, Freddy Trujillo; Ochoa, Marco; Chiriboga, Monica; Astudillo, Fernando; Heisler, Michele; Merajver, Sofia

2012-05-01

Disease management following hospital discharge is difficult in most low-resourced areas, posing a major obstacle to health equity. Although mobile phones are a ubiquitous and promising technology to facilitate healthcare access, few studies have tested the acceptability and feasibility of patients themselves using the devices for assisting linkages to healthcare services. We hypothesized that patients would use mobile phones to help manage postdischarge problems, if given a communication protocol. We developed a mobile phone-based program and investigated its acceptability and feasibility as a method of delivering posthospitalization care. A consecutive cohort of adult patients in a public hospital in Quito, Ecuador was enrolled over a 1-month period. A hospital-based nurse relayed patients' discharge instructions to a community-based nurse. Patients corresponded with this nurse via text messaging and phone calls according to a protocol to initiate and participate in follow-up. Eighty-nine percent of eligible patients participated. Ninety-seven percent of participants completed at least one contact with the nurse; 81% initiated contact themselves. Nurses completed 262 contacts with 32 patients, clarifying discharge instructions, providing preventive education, and facilitating clinic appointments. By this method, 87% of patients were successfully linked to follow-up appointments. High levels of patient participation and successful delivery of follow-up services indicate the mobile phone program's acceptability and feasibility for facilitating posthospitalization follow-up. Patients actively used mobile phones to interact with nurses, enabling the provision of posthospitalization medical advice and facilitate community-based care via mobile phone.

7 CFR 1494.101 - General statement.

Code of Federal Regulations, 2011 CFR

2011-01-01

... (Invitation). Invitations will be issued pursuant to this subpart by the General Sales Manager (GSM) and will... specifications), the eligible buyer(s), the method and rate for determining liquidated damages and performance... one of the following two types: Those inviting exporters which have a sales contract with an eligible...

5 CFR 302.304 - Order of consideration.

Code of Federal Regulations, 2010 CFR

2010-01-01

... her right of appeal to the Merit Systems Protection Board. (b) Consideration of other candidates... eligible ratings for professional and scientific positions at the GS-9 level and above, or equivalent, in... of the following orders: (i) By preference status. Under this method, preference eligibles having a...

45 CFR 149.325 - Requirements for eligibility of claims.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Section 149.325 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES REQUIREMENTS RELATING TO HEALTH CARE ACCESS REQUIREMENTS FOR THE EARLY RETIREE REINSURANCE PROGRAM Reimbursement Methods § 149.325 Requirements for eligibility of claims. A claim may be submitted only if it represents costs for health...

45 CFR 149.325 - Requirements for eligibility of claims.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Section 149.325 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES REQUIREMENTS RELATING TO HEALTH CARE ACCESS REQUIREMENTS FOR THE EARLY RETIREE REINSURANCE PROGRAM Reimbursement Methods § 149.325 Requirements for eligibility of claims. A claim may be submitted only if it represents costs for health...

The Prevalence of Zinc Deficiency in Patients With Thalassemia in South East of Iran, Sistan and Baluchistan Province

PubMed Central

Mashhadi, Mohammad Ali; Sepehri, Zahra; Heidari, Zahra; Shirzaee, Eghbal; Kiani, Zohre

2014-01-01

Background: There are different and controversial reports about zinc deficiency in patients with major thalassemia. Objectives: The aim of this study was to evaluate zinc status in patients with major thalassemia in Sistan and Baluchistan province, southeastern Iran. Patients and Methods: The study was performed in Ali Asghar Hospital, a specialized governmental hospital located in Zahedan, Iran. In this cross-sectional study, 369 patients with a history of major thalassemia for more than 5 years entered the study using convenience sampling method. Thirty-six subjects were excluded from the study based on our exclusion criteria. Zinc level was measured in all patients after 12 hours fasting using atomic absorption spectrometry method in 2012. Results: Of 369 cases, 333 patients were eligible and evaluated. The mean age was 15.63 ± 7.4 years. One hundred ninety two cases were male and others were female (141 cases). About 27% (90) of the cases were 5-10 years-old, 24% (80) were 10-15 years-old and 49% were older than 15 years old. Iron chelator in 65.46% was Desferrioxamine, in 28.2% was Deferasirox and in 19.5% was combination of Desferrioxamine and Deferiprone. All cases had zinc deficiency, and 98.5% had severe zinc deficiency. Others (1.5%) had mild deficiency. Conclusions: Our study on 333 patients with major thalassemia documented severe zinc deficiency in all cases. We had no cases with normal or increased zinc levels. It was different with other reports in the world. PMID:25389495

Outcomes of Medicare-age eligible NHL patients receiving RIC allogeneic transplantation: a CIBMTR analysis.

PubMed

Shah, Nirav N; Ahn, Kwang Woo; Litovich, Carlos; Fenske, Timothy S; Ahmed, Sairah; Battiwalla, Minoo; Bejanyan, Nelli; Dahi, Parastoo B; Bolaños-Meade, Javier; Chen, Andy I; Ciurea, Stefan O; Bachanova, Veronika; DeFilipp, Zachariah; Epperla, Narendranath; Farhadfar, Nosha; Herrera, Alex F; Haverkos, Bradley M; Holmberg, Leona; Hossain, Nasheed M; Kharfan-Dabaja, Mohamed A; Kenkre, Vaishalee P; Lazarus, Hillard M; Murthy, Hemant S; Nishihori, Taiga; Rezvani, Andrew R; D'Souza, Anita; Savani, Bipin N; Ulrickson, Matthew L; Waller, Edmund K; Sureda, Anna; Smith, Sonali M; Hamadani, Mehdi

2018-04-24

The application of allogeneic hematopoietic cell transplantation (allo-HCT) in non-Hodgkin lymphoma (NHL) patients ≥65 years in the United States is limited by lack of Medicare coverage for this indication. Using the Center for International Blood and Marrow Transplant Research (CIBMTR) database, we report allo-HCT outcomes of NHL patients aged ≥65 years (older cohort; n = 446) compared with a cohort of younger NHL patients aged 55-64 years (n = 1183). We identified 1629 NHL patients undergoing a first reduced-intensity conditioning (RIC) or nonmyeloablative conditioning allo-HCT from 2008 to 2015 in the United States. Cord blood or haploidentical transplants were excluded. The median age was 68 years (range 65-77) for the older cohort vs 60 years (range 55-64) in the younger cohort. The 4-year adjusted probabilities of nonrelapse mortality (NRM), relapse/progression (R/P), progression-free survival (PFS), and overall survival (OS) of the younger and older groups were 24% vs 30% ( P = .03), 41% vs 42% ( P = .82), 37% vs 31% ( P = .03), and 51% vs 46% ( P = .07), respectively. Using multivariate analysis, compared with the younger group, the older cohort was associated with increased NRM, but there was no difference between the 2 cohorts in terms of R/P, PFS, or OS. The most common cause of death was disease relapse in both groups. In NHL patients eligible for allo-HCT, there was no difference in OS between the 2 cohorts. Age alone should not determine allo-HCT eligibility in NHL, and Medicare should expand allo-HCT coverage to older adults.

Outcomes of Medicare-age eligible NHL patients receiving RIC allogeneic transplantation: a CIBMTR analysis

PubMed Central

Shah, Nirav N.; Ahn, Kwang Woo; Litovich, Carlos; Fenske, Timothy S.; Ahmed, Sairah; Battiwalla, Minoo; Bejanyan, Nelli; Dahi, Parastoo B.; Bolaños-Meade, Javier; Chen, Andy I.; Ciurea, Stefan O.; Bachanova, Veronika; DeFilipp, Zachariah; Epperla, Narendranath; Farhadfar, Nosha; Herrera, Alex F.; Haverkos, Bradley M.; Holmberg, Leona; Hossain, Nasheed M.; Kharfan-Dabaja, Mohamed A.; Kenkre, Vaishalee P.; Lazarus, Hillard M.; Murthy, Hemant S.; Nishihori, Taiga; Rezvani, Andrew R.; D’Souza, Anita; Savani, Bipin N.; Ulrickson, Matthew L.; Waller, Edmund K.; Sureda, Anna; Smith, Sonali M.

2018-01-01

The application of allogeneic hematopoietic cell transplantation (allo-HCT) in non-Hodgkin lymphoma (NHL) patients ≥65 years in the United States is limited by lack of Medicare coverage for this indication. Using the Center for International Blood and Marrow Transplant Research (CIBMTR) database, we report allo-HCT outcomes of NHL patients aged ≥65 years (older cohort; n = 446) compared with a cohort of younger NHL patients aged 55-64 years (n = 1183). We identified 1629 NHL patients undergoing a first reduced-intensity conditioning (RIC) or nonmyeloablative conditioning allo-HCT from 2008 to 2015 in the United States. Cord blood or haploidentical transplants were excluded. The median age was 68 years (range 65-77) for the older cohort vs 60 years (range 55-64) in the younger cohort. The 4-year adjusted probabilities of nonrelapse mortality (NRM), relapse/progression (R/P), progression-free survival (PFS), and overall survival (OS) of the younger and older groups were 24% vs 30% (P = .03), 41% vs 42% (P = .82), 37% vs 31% (P = .03), and 51% vs 46% (P = .07), respectively. Using multivariate analysis, compared with the younger group, the older cohort was associated with increased NRM, but there was no difference between the 2 cohorts in terms of R/P, PFS, or OS. The most common cause of death was disease relapse in both groups. In NHL patients eligible for allo-HCT, there was no difference in OS between the 2 cohorts. Age alone should not determine allo-HCT eligibility in NHL, and Medicare should expand allo-HCT coverage to older adults. PMID:29685953

Breast imaging. A practical look at its capabilities and its limitations.

PubMed

Clark, R; Nemec, L; Love, N

1992-10-01

The film-screen technique is evolving as the standard for mammography. Sonography is the only other method that currently has a defined role in breast imaging. Mammography should be performed at facilities that have received American College of Radiology accreditation or its equivalent, because technical quality assurance is an important part of mammographic practice. Interpretive quality may be assured by outcome audits performed by mammography facilities. Primary care physicians are best suited to encouraging eligible women to undergo screening studies and should consider these recommendations: Refer patients for screening mammography to accredited facilities according to established guidelines. Educate patients about the need for regular screening. Provide annual breast physical examination. Refresh your knowledge on breast health and the techniques of physical examination if necessary. Teach patients breast self-examination techniques. Demand low-cost, high-quality screening mammography; be aware of local variability of charges and quality.

Role of (123)I-Iobenguane Myocardial Scintigraphy in Predicting Short-term Left Ventricular Functional Recovery: An Interesting Image.

PubMed

Feola, Mauro; Chauvie, Stephane; Biggi, Alberto; Testa, Marzia

2015-01-01

(123)I-iobenguane myocardial scintigraphy (MIBG) has been shown to be a predictor of sudden cardiac mortality in patients with heart failure. One patient with recent anterior myocardial infarction (MI) treated with coronary angioplasty and having left ventricular ejection fraction (LVEF) of 30% underwent early MIBG myocardial scintigraphy/tetrofosmin single-photon emission computed tomography (SPECT) in order to help evaluate his eligibility for implantable cardioverter defibrillator (ICD). The late heart/mediastinum (H/M) ratio was calculated to be 1.32% and the washout rate was 1%. At 40-day follow-up after angioplasty, LVEF proved to be 32%, New York Heart Association (NYHA) class was still II-III, and an ICD was placed in order to reduce mortality from ventricular arrhythmias. MIBG myocardial scintigraphy might be a promising method for evaluating left ventricular recovery in post-MI patients.

Online continuing medical education (CME) for GPs: does it work? A systematic review.

PubMed

Thepwongsa, Isaraporn; Kirby, Catherine N; Schattner, Peter; Piterman, Leon

2014-10-01

Numerous studies have assessed the effectiveness of online continuing medical education (CME) designed to improve healthcare professionals' care of patients. The effects of online educational interventions targeted at general practitioners (GP), however, have not been systematically reviewed. A computer search was conducted through seven databases for studies assessing changes in GPs' knowledge and practice, or patient outcomes following an online educational intervention. Eleven studies met the eligibility criteria. Most studies (8/11, 72.7%) found a significant improvement in at least one of the following outcomes: satisfaction, knowledge or practice change. There was little evidence for the impact of online CME on patient outcomes. Variability in study design, characteristics of online and outcome measures limited conclusions on the effects of online CME. Online CME could improve GP satisfaction, knowledge and practices but there are very few well-designed studies that focus on this delivery method of GP education.