Key pharmacovigilance stakeholders' experiences of direct patient reporting of adverse drug reactions and their prospects of future development in the European Union.

PubMed

Inácio, P; Cavaco, A; Allan, E; Airaksinen, M

2018-02-01

In the European Union (EU), legislation allows patients to directly report adverse drug reactions (ADRs) to competent authorities. Five years after its implementation, patient reporting is not equal in all countries. This study aimed to explore key stakeholders' perceptions of patient reporting in four EU countries. Qualitative study design. Twelve representatives from national pharmacovigilance centres and/or authorities as well as national pharmaceutical industry bodies in four EU countries participated in the study. Supranational organizations were also included. Data collection was via face-semi-structured interviews. Inductive content analysis was performed thereafter, applying principles of risk management as a theoretical framework. Four themes (attitudes and beliefs, system maturation factors, regulatory improvements, and cultural shifts) emerged, conceptually interconnected. Participants from countries introducing patient reporting recently expressed a negative attitude. Participants highlighted the need for additional resources, both human and financial, to address patient reporting and associated advantages. The findings identified perceived barriers and facilitators of patient reporting. The involvement of patients, use of information, and dissemination of patient reporting are far from optimal. A better integration of the work by EU regulatory authorities is recommended. Copyright © 2017 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Systematic Review of Radiation Therapy Toxicity Reporting in Randomized Controlled Trials of Rectal Cancer: A Comparison of Patient-Reported Outcomes and Clinician Toxicity Reporting

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

Gilbert, Alexandra, E-mail: a.gilbert@leeds.ac.uk; Ziegler, Lucy; Martland, Maisie

The use of multimodal treatments for rectal cancer has improved cancer-related outcomes but makes monitoring toxicity challenging. Optimizing future radiation therapy regimens requires collection and publication of detailed toxicity data. This review evaluated the quality of toxicity information provided in randomized controlled trials (RCTs) of radiation therapy in rectal cancer and focused on the difference between clinician-reported and patient-reported toxicity. Medline, EMBASE, and the Cochrane Library were searched (January 1995-July 2013) for RCTs reporting late toxicity in patients treated with regimens including preoperative (chemo)radiation therapy. Data on toxicity measures and information on toxicity reported were extracted using Quantitative Analyses ofmore » Normal Tissue Effects in the Clinic recommendations. International Society for Quality of Life Research standards on patient-reported outcomes (PROs) were used to evaluate the quality of patient-reported toxicity. Twenty-one RCT publications met inclusion criteria out of 4144 articles screened. All PRO studies reported higher rates of toxicity symptoms than clinician-reported studies and reported on a wider range and milder symptoms. No clinician-reported study published data on sexual dysfunction. Of the clinician-reported studies, 55% grouped toxicity data related to an organ system together (eg “Bowel”), and 45% presented data only on more-severe (grade ≥3) toxicity. In comparison, all toxicity grades were reported in 79% of PRO publications, and all studies (100%) presented individual symptom toxicity data (eg bowel urgency). However, PRO reporting quality was variable. Only 43% of PRO studies presented baseline data, 28% did not use any psychometrically validated instruments, and only 29% of studies described statistical methods for managing missing data. Analysis of these trials highlights the lack of reporting standards for adverse events and reveals the differences between clinician and patient reporting of toxicity. Recommendations for improving the quality of adverse event data collection are provided, with the aim of improving critical appraisal of outcomes for future studies.« less

Does varenicline worsen psychiatric symptoms in patients with schizophrenia or schizoaffective disorder? A review of published studies.

PubMed

Cerimele, Joseph M; Durango, Alejandra

2012-08-01

To review published cases and prospective studies describing the use of varenicline in patients with schizophrenia and schizoaffective disorder. PubMed, PsychINFO, and the Cochrane Database were searched in July 2011 using the key words schizophrenia, schizoaffective disorder, psychosis, positive symptoms, negative symptoms, aggression, hostility, suicidal ideation AND varenicline to identify reports published between January 2006 and July 2011 in English. Five case reports, 1 case series, 1 retrospective study, 10 prospective studies (17 publications), and 1 meeting abstract describing the use of varenicline in patients with schizophrenia or schizoaffective disorder were identified. Review articles and articles describing findings other than the use of varenicline in patients with schizophrenia or schizoaffective disorder were excluded. Thirteen reports were included in the final analysis. Information on each study's patient population, age, diagnosis, medication treatment, tobacco use history, adverse effects, and outcome was collected from the published reports. Of the 260 patients with schizophrenia or schizoaffective disorder who received varenicline in these published reports, 13 patients (5%) experienced the onset or worsening of any psychiatric symptom, although 3 of the 13 patients experienced a very brief negative effect after 1 dose. No patients experienced suicidal ideation or suicidal behaviors. Published reports suggest that, in most stable, closely monitored patients with schizophrenia or schizoaffective disorder, varenicline treatment is not associated with worsening of psychiatric symptoms. Current, prospective studies are assessing effectiveness and further assessing safety in this population. © Copyright 2012 Physicians Postgraduate Press, Inc.

Provider Factors and Patient-Reported Healthcare Discrimination in the Diabetes Study of California (DISTANCE)

PubMed Central

Lyles, Courtney R.; Karter, Andrew J.; Young, Bessie A.; Spigner, Clarence; Grembowski, David; Schillinger, Dean; Adler, Nancy

2011-01-01

Objective We examined provider-level factors and reported discrimination in the healthcare setting. Methods With data from the Diabetes Study of Northern California (DISTANCE)—a race-stratified survey of diabetes patients in Kaiser Permanente Northern California—we analyzed patient-reported racial/ethnic discrimination from providers. Primary exposures were characteristics of the primary care provider (PCP, who coordinates care in this system), including specialty/type, and patient-provider relationship variables including racial concordance. Results Subjects (n=12,151) included 20% black, 20% Latino, 23% Asian, 30% white, and 6% other patients, with 2% to 8% reporting discrimination by racial/ethnic group. Patients seeing nurse practitioners as their PCP (OR=0.09; 95% CI: 0.01–0.67), those rating their provider higher on communication (OR=0.70; 95% CI: 0.66–0.74) were less likely to report discrimination, while those with more visits (OR=1.10; 95% CI: 1.03–1.18) were more likely to report discrimination. Racial concordance was not significant once adjusting for patient race/ethnicity. Conclusions Among diverse diabetes patients in managed care, provider type and communication were significantly related to patient-reported discrimination. Practice Implications Given potential negative impacts on patient satisfaction and treatment decisions, future studies should investigate which interpersonal aspects of the provider-patient relationship reduce patient perceptions of unfair treatment. PMID:21605956

Comparative effectiveness studies examining patient-reported outcomes among children with cleft lip and/or palate: a systematic review.

PubMed

Ranganathan, Kavitha; Vercler, Christian J; Warschausky, Seth A; MacEachern, Mark P; Buchman, Steven R; Waljee, Jennifer F

2015-01-01

Health care policy makers are increasingly encouraging comparative effectiveness research. Little is known regarding comparative studies among children with cleft lip and/or palate. Cleft lip and/or palate profoundly influences self-perception and social functioning, and patient-reported outcomes provide a unique perspective on the success of reconstruction. The purpose of this study was to systematically review the literature regarding patient-reported outcomes among patients with cleft lip and/or palate. The authors reviewed articles from MEDLINE, Embase, and PsycInfo that examined the use of patient-reported outcome instruments for cleft lip and/or palate. Studies of patients with cleft lip and/or palate across any age that described the use of patient-completed measures in patient and control populations were included. A research librarian confirmed the search, and two independent, blinded reviewers performed full-text review. The authors identified 1979 articles and selected 30 for inclusion. Forty-two different assessment tools were used to analyze factors such as self-esteem, behavior, and social support. The Strengths and Difficulties Questionnaire was most commonly used (n = 7), followed by the Childhood Experience Questionnaire (n = 5), and the Satisfaction with Appearance survey (n = 4). Barriers to analysis included lack of standardization of survey administration, effect of publication bias, and variations in patient populations between individual studies. Comparative studies of patient-reported outcomes among patients with cleft lip and/or palate are infrequent. Many instruments exist to measure patient-reported outcomes in this population, but no specific standard exists. Identifying efficient and targeted forms of instrument selection and administration will enhance comparative studies among children with cleft lip and/or palate. Diagnostic, III.

Patient-Reported Outcomes and Total Health Care Expenditure in Prediction of Patient Satisfaction: Results From a National Study

PubMed Central

Zhang, Weiping; Chen, Wei; Bounsanga, Jerry; Cheng, Christine; Franklin, Jeremy D; Crum, Anthony B; Voss, Maren W; Hon, Shirley D

2015-01-01

Background Health care quality is often linked to patient satisfaction. Yet, there is a lack of national studies examining the relationship between patient satisfaction, patient-reported outcomes, and medical expenditure. Objective The aim of this study is to examine the contribution of physical health, mental health, general health, and total health care expenditures to patient satisfaction using a longitudinal, nationally representative sample. Methods Using data from the 2010-2011 Medical Expenditure Panel Survey, analyses were conducted to predict patient satisfaction from patient-reported outcomes and total health care expenditures. The study sample consisted of adult participants (N=10,157), with sampling weights representative of 233.26 million people in the United States. Results The results indicated that patient-reported outcomes and total health care expenditure were associated with patient satisfaction such that higher physical and mental function, higher general health status, and higher total health care expenditure were associated with higher patient satisfaction. Conclusions We found that patient-reported outcomes and total health care expenditure had a significant relationship with patient satisfaction. As more emphasis is placed on health care value and quality, this area of research will become increasingly needed and critical questions should be asked about what we value in health care and whether we can find a balance between patient satisfaction, outcomes, and expenditures. Future research should apply big data analytics to investigate whether there is a differential effect of patient-reported outcomes and medical expenditures on patient satisfaction across different medical specialties. PMID:27227131

Electronic patient-reported outcomes from home in patients recovering from major gynecologic cancer surgery: A prospective study measuring symptoms and health-related quality of life.

PubMed

Cowan, Renee A; Suidan, Rudy S; Andikyan, Vaagn; Rezk, Youssef A; Einstein, M Heather; Chang, Kaity; Carter, Jeanne; Zivanovic, Oliver; Jewell, Elizabeth J; Abu-Rustum, Nadeem R; Basch, Ethan; Chi, Dennis S

2016-11-01

We previously reported on the feasibility of a Web-based system to capture patient-reported outcomes (PROs) in the immediate postoperative period. The purpose of this study was to update the experience of these patients and assess patient and provider satisfaction and feedback regarding the system. This is a prospective cohort study of patients scheduled to undergo laparotomy for presumed gynecologic malignancy. Patients completed a Web-based Symptom Tracking and Reporting (STAR) questionnaire preoperatively and weekly during a 6-week postoperative period. Email alerts were sent to study nurses when concerning patient responses were entered. The patient and the nurse assessments of STAR's usefulness were measured via an exit survey. The study enrolled 96 eligible patients. Of these, 71 patients (74%) completed at least four of seven total sessions. Of the patients who completed the exit satisfaction survey, 98% found STAR easy to use; 84% found it useful; and 82% would recommend it to other patients. Despite positive feedback from patients, clinical personnel found that the STAR system increased their current workload without enhancing patient care. Application of an electronic program for PROs in those recovering from major gynecologic cancer surgery is feasible, and acceptable to most patients. While most clinicians did not find STAR clinically helpful, the majority of patients reported a positive experience with the system and would recommend its use. The program helped many patients feel more empowered in their postoperative recovery. Copyright © 2016 Elsevier Inc. All rights reserved.

Reporting Severe Hypoglycemia in Type 1 Diabetes: Facts and Pitfalls.

PubMed

Pedersen-Bjergaard, Ulrik; Thorsteinsson, Birger

2017-10-28

To describe potential factors influencing reporting of severe hypoglycemia in adult patients with type 1 diabetes and to analyze their effect on reported rates of severe hypoglycemia. Reported rates of severe hypoglycemia defined as need for third party assistance vary between 0.3-3.0 events per patient-year in unselected cohorts, corresponding to a yearly prevalence range of 10-53%. When defined as need for parenteral therapy with glucose or glucagon or need for admission to an emergency unit or hospitalization, incidence and prevalence rates of severe hypoglycemia are 0.02-0.5 events per patient-year and 1-29%, respectively. When subjects with recurrent severe hypoglycemia in the past or suffering from impaired hypoglycemia awareness are excluded from participation in studies, lower rates are reported. Studies applying anonymous reporting or reporting by partners report higher rates of severe hypoglycemia. There is a large variation between studies reporting incidence and prevalence of severe hypoglycemia in patients with type 1 diabetes, mainly explained by definition of severity, methods of reporting, and patient selection. These findings call for consensus about hypoglycemia definition and reporting in future research.

What Is the Proportion of Studies Reporting Patient and Practitioner Satisfaction with Software Support Tools Used in the Management of Knee Pain and Is This Related to Sample Size, Effect Size, and Journal Impact Factor?

PubMed

Bright, Philip; Hambly, Karen

2017-12-21

E-health software tools have been deployed in managing knee conditions. Reporting of patient and practitioner satisfaction in studies regarding e-health usage is not widely explored. The objective of this review was to identify studies describing patient and practitioner satisfaction with software use concerning knee pain. A computerized search was undertaken: four electronic databases were searched from January 2007 until January 2017. Key words were decision dashboard, clinical decision, Web-based resource, evidence support, and knee. Full texts were scanned for effect of size reporting and satisfaction scales from participants and practitioners. Binary regression was run; impact factor and sample size were predictors with indicators for satisfaction and effect size reporting as dependent variables. Seventy-seven articles were retrieved; 37 studies were included in final analysis. Ten studies reported patient satisfaction ratings (27.8%): a single study reported both patient and practitioner satisfaction (2.8%). Randomized control trials were the most common design (35%) and knee osteoarthritis the most prevalent condition (38%). Electronic patient-reported outcome measures and Web-based training were the most common interventions. No significant dependency was found within the regression models (p > 0.05). The proportion of reporting of patient satisfaction was low; practitioner satisfaction was poorly represented. There may be implications for the suitability of administering e-health, a medium for capturing further meta-evidence needs to be established and used as best practice for implicated studies in future. This is the first review of its kind to address patient and practitioner satisfaction with knee e-health.

Sleep assessment by patients and nurses in the intensive care: An exploratory descriptive study.

PubMed

Aitken, Leanne M; Elliott, Rosalind; Mitchell, Marion; Davis, Chelsea; Macfarlane, Bonnie; Ullman, Amanda; Wetzig, Krista; Datt, Ashika; McKinley, Sharon

2017-03-01

Sleep disruption is common in intensive care unit (ICU) patients, with reports indicating reduced quality and quantity of sleep in many patients. There is growing evidence that sleep in this setting may be improved. To describe ICU patients' self-report assessment of sleep, examine the relationship between patients' self-reported sleep and their reported sleep by the bedside nurse, and describe the strategies suggested by patients to promote sleep. An exploratory descriptive study was undertaken with communicative adult patients consecutively recruited in 2014-2015. Patients reported sleep using the Richards-Campbell Sleep Questionnaire (score range 0-100mm; higher score indicates better sleep quality), with nursing assessment of sleep documented across a five level ordinal variable. Patients were asked daily to describe strategies that helped or hindered their sleep. Ethical approval for the study was gained. Descriptive statistical analysis was performed [median (interquartile range)]; relationships were tested using Spearman's rank correlation and differences assessed using the Kruskal-Wallis test; p<0.05 was considered significant. Participants (n=151) were recruited [age: 60 (46-71) years; ICU length of stay 4 (2-9) days] with 356 self-reports of sleep. Median perceived sleep quality was 46 (26-65) mm. A moderate relationship existed between patients' self-assessment and nurses' assessment of sleep (Spearman's rank correlation coefficient 0.39-0.50; p<0.001). Strategies identified by patients to improve sleep included adequate pain relief and sedative medication, a peaceful and comfortable environment and physical interventions, e.g. clustering care, ear plugs. Patients reported on their sleep a median of 2 (1-3) days during their ICU stay, suggesting that routine use of self-report was feasible. These reports revealed low sleep quality. Patients reported multiple facilitators and barriers for sleep, with environmental and patient comfort factors being most common. Interventions that target these factors to improve patient sleep should be implemented. Copyright © 2016 Australian College of Critical Care Nurses Ltd. Published by Elsevier Ltd. All rights reserved.

Effect of an anonymous reporting system on near-miss and harmful medical error reporting in a pediatric intensive care unit.

PubMed

Grant, Mary Jo C; Larsen, Gitte Y

2007-01-01

Adverse event reporting is a key element for improving patient safety. This study describes a new voluntary, anonymous reporting system that facilitates reporting of near-miss and patient harm events and an assessment of patient harm by the bedside care provider in a pediatric intensive care unit. The results demonstrated the effectiveness of the Patient Safety Report as a method to capture near-miss and patient harm events.

Concordance of patient and caregiver reports in evaluating quality of life in patients with malignant gliomas and an assessment of caregiver burden

PubMed Central

Jacobs, Daniel I.; Kumthekar, Priya; Stell, Becky V.; Grimm, Sean A.; Rademaker, Alfred W.; Rice, Laurie; Chandler, James P.; Muro, Kenji; Marymont, MaryAnne; Helenowski, Irene B.; Wagner, Lynne I.; Raizer, Jeffrey J.

2014-01-01

Background Given the neurocognitive impairment experienced by many patients with malignant gliomas, caregiver reports can be critical in assessing the quality of life (QOL) of these patients. In this study, we explored whether assessment of patient QOL by the primary caregiver shows concordance with the patient's self-reported QOL, and we quantified the burden faced by caregivers. Methods QOL of 45 patients was evaluated by both the patient and primary caregiver on 3 or more separate occasions using the Functional Assessment of Cancer Therapy-Brain (FACT-Br) instrument, and concordance between the 2 reports was evaluated. Caregiver burden was measured using the Caregiver Quality of Life Index-Cancer (CQOL-C) instrument. Results Overall, good concordance was observed between the patient and caregiver FACT-Br reports (intraclass correlation coefficient = 0.74). Patient-reported FACT-Br scores were 4.75 (95% CI, 1.44–8.05) points higher than paired caregiver reports on the 200-point scale (P = .008); however, this difference did not achieve clinical significance. Caregiver burden, as measured by the CQOL-C, was significantly greater among caregivers in this study than those previously reported for caregivers of patients with lung, breast, or prostate cancer (P < .001). Conclusions Despite minor discrepancies in caregiver assessments of patient QOL relative to patient self-reports, our results suggest that the caregiver assessments can serve as adequate proxies for patient reports. Our results also illustrate the particularly heavy burden faced by caregivers of patients with malignant glioma. Further research into both of these areas is warranted. PMID:26034616

Patient participation in bedside reporting on surgical wards.

PubMed

Timonen, L; Sihvonen, M

2000-07-01

Increasingly nowadays, patients have an opportunity to take part in nurses' reporting sessions via bedside reporting. The aim of this study was to compare nurses' and patients' opinions of the purpose of bedside reports, patient participation in bedside reporting sessions, and factors that promote or prevent their participation. Data were collected by a questionnaire survey of nurses (N = 118) and patients (N = 74). A response rate of 81% was achieved in both groups. Additionally, 76 bedside reporting sessions were observed. According to patients, the main reasons for not participating were tiredness, difficulties in formulating questions, lack of encouragement, difficulties with the language used, nurses concentrating more on their papers than on them, and the reporting sessions were too short. Nurses reported that patients took a more active part in reporting sessions than patients themselves thought. The average time spent on each patient's report was three minutes.

Patient-reported experiences of patient safety incidents need to be utilized more systematically in promoting safe care.

PubMed

Sahlström, Merja; Partanen, Pirjo; Turunen, Hannele

2018-04-16

To analyze patient safety incidents (PSIs) reported by patients and their use in Finnish healthcare organizations. Cross-sectional study. About 15 Finnish healthcare organizations ranging from specialized hospital care to home care, outpatient and inpatient clinics, and geographically diverse areas of Finland. The study population included all Finnish patients who had voluntarily reported PSI via web-based system in 2009-15. Quantitative analysis of patients' safety reports, inductive content analysis of patients' suggestions to prevent the reoccurrence incidents and how those suggestions were used in healthcare organizations. Patients reported 656 PSIs, most of which were classified by the healthcare organizations' analysts as problems associated with information flow (32.6%) and medications (18%). Most of the incidents (65%) did not cause any harm to patients. About 76% of the reports suggested ways to prevent reoccurrence of PSIs, most of which were feasible, system-based amendments of processes for reviewing or administering treatment, anticipating risks or improving diligence in patient care. However, only 6% had led to practical implementation of corrective actions in the healthcare organizations. The results indicate that patients report diverse PSIs and suggest practical systems-based solutions to prevent their reoccurrence. However, patients' reports rarely lead to corrective actions documented in the registering system, indicating that there is substantial scope to improve utilization of patients' reports. There is also a need for strong patient safety management, including willingness and commitment of HCPs and leaders to learn from safety incidents.

Patient-reported outcomes and diabetes technology: a systematic review of the literature.

PubMed

Rubin, Richard R; Peyrot, Mark

2010-08-01

Advanced diabetes technology should have benefits not only in terms of clinical outcomes, but also in terms of patient-reported outcomes. The objective of this paper is to review the methodology and findings of studies that assessed the effects of diabetes technologies such as continuous subcutaneous insulin infusion (CSII), continuous glucose monitoring (CGM), and integrated CSII/CGM on patientreported outcomes. The existing literature in pediatric and adult patients is limited, so there is no conclusive evidence that use of CSII, CGM, or integrated CSII/CGM systems produce improved patient-reported outcomes, but most studies provide evidence that these technologies yield some patient-reported outcomes advantages, and few indicate any disadvantages. We expect that more robust studies in the future will provide further evidence regarding the impact of these technologies for patient-reported outcomes, including general health-related quality-of-life, diabetesspecific quality-of-life, treatment satisfaction, and treatment preference.

Patient-clinician agreement on signs and symptoms of 'strep throat': a MetroNet study.

PubMed

Xu, Jinping; Schwartz, Kendra; Monsur, Joseph; Northrup, Justin; Neale, Anne Victoria

2004-12-01

Despite substantial use of the telephone in health care, only a few studies have formally evaluated the appropriateness of telephone-based management for acute medical problems. The accuracy of patients' report of signs and symptoms remains unknown. We compared the agreement between patient self-assessment and clinician assessment on the typical signs and symptoms of group A beta-haemolytic Streptococcus (GABHS) to investigate the potential difficulties of using patient self-report to triage sore throat patients. In this cross-sectional study, each of 200 adult pharyngitis patients was instructed to examine him/herself and to record the symptoms and physical findings. Two clinicians independently interviewed and examined each patient and recorded their findings. Each patient then had a rapid GABHS antigen test, the results of which were blinded to both clinicians and patients. Each patient self-assessment was compared with the findings of each clinician, and the agreement and disagreement between them computed. We found varying levels of agreement (kappa=-0.05 to 0.71) between patients and clinicians on sore throat history and physical assessments. Importantly, there was fair to substantial agreement (kappa=0.20-0.71) on the key signs and symptoms used in GABHS clinical prediction rules. As expected, history items had the highest agreement (kappa=0.52-0.71). Patients were more likely than clinicians to report rather than deny a specific physical sign. Adult sore throat patients may reliably report their symptoms, but may not be able to assess and report accurately on relevant physical signs of pharyngitis. Patients have a tendency to over-report physical signs. This study indicates the potential difficulties associated with telephone triage of sore throat patients, or other illnesses that require assessment of physical signs.

Preoperative physical examination and imaging of femoroacetabular impingement prior to hip arthroscopy-a systematic review.

PubMed

Haldane, Chloe E; Ekhtiari, Seper; de Sa, Darren; Simunovic, Nicole; Ayeni, Olufemi R

2017-08-01

The purpose of this systematic review is to report current preoperative assessment for femoroacetabular impingement (FAI) including physical examination and imaging modalities prior to hip arthroscopy, and report current imaging measures used in the diagnosis of FAI. The electronic databases MEDLINE, EMBASE and PubMed were searched and screened in duplicate for relevant studies. Data regarding patient demographics, non-operative treatment, preoperative assessment including physical examination and imaging prior to hip arthroscopy were abstracted. Study quality was assessed in duplicate using the Methodological Index for Non-Randomized Studies criteria. Sixty-eight studies of fair quality evidence that involved a total of 5125 patients (5400 hips) were included. In total, 56% of all patients were male and mean age was 36 years (SD ± 10.0). Within physical examination, FADIR impingement testing was reported in 57% of patients. All included studies reported plain radiographic imaging as a component of preoperative assessment with anterior-posterior pelvis view being the most commonly reported view, followed by the cross-table lateral and Dunn views. Magnetic resonance imaging was obtained for 52% of included patients and computed tomography for 26% of patients. The most commonly reported measure within imaging for the diagnosis of cam type impingement was alpha angle (66%), whereas for pincer type impingement, the cross-over sign (48%) was most reported. Preoperative assessment is underreported in the FAI literature. Improved reporting is warranted to develop a more consistent and validated diagnostic algorithm for FAI to enhance patient selection. Level of evidence : Level IV, Systematic Review of Level I-IV Studies.

Preoperative physical examination and imaging of femoroacetabular impingement prior to hip arthroscopy—a systematic review

PubMed Central

Haldane, Chloe E.; Ekhtiari, Seper; de SA, Darren; Simunovic, Nicole

2017-01-01

Abstract The purpose of this systematic review is to report current preoperative assessment for femoroacetabular impingement (FAI) including physical examination and imaging modalities prior to hip arthroscopy, and report current imaging measures used in the diagnosis of FAI. The electronic databases MEDLINE, EMBASE and PubMed were searched and screened in duplicate for relevant studies. Data regarding patient demographics, non-operative treatment, preoperative assessment including physical examination and imaging prior to hip arthroscopy were abstracted. Study quality was assessed in duplicate using the Methodological Index for Non-Randomized Studies criteria. Sixty-eight studies of fair quality evidence that involved a total of 5125 patients (5400 hips) were included. In total, 56% of all patients were male and mean age was 36 years (SD ± 10.0). Within physical examination, FADIR impingement testing was reported in 57% of patients. All included studies reported plain radiographic imaging as a component of preoperative assessment with anterior–posterior pelvis view being the most commonly reported view, followed by the cross-table lateral and Dunn views. Magnetic resonance imaging was obtained for 52% of included patients and computed tomography for 26% of patients. The most commonly reported measure within imaging for the diagnosis of cam type impingement was alpha angle (66%), whereas for pincer type impingement, the cross-over sign (48%) was most reported. Preoperative assessment is underreported in the FAI literature. Improved reporting is warranted to develop a more consistent and validated diagnostic algorithm for FAI to enhance patient selection. Level of evidence: Level IV, Systematic Review of Level I–IV Studies. PMID:28948032

Prescription Opioid Analgesics Commonly Unused After Surgery: A Systematic Review.

PubMed

Bicket, Mark C; Long, Jane J; Pronovost, Peter J; Alexander, G Caleb; Wu, Christopher L

2017-11-01

Prescription opioid analgesics play an important role in the treatment of postoperative pain; however, unused opioids may be diverted for nonmedical use and contribute to opioid-related injuries and deaths. To quantify how commonly postoperative prescription opioids are unused, why they remain unused, and what practices are followed regarding their storage and disposal. MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials were searched from database inception to October 18, 2016, for studies describing opioid oversupply for adults after a surgical procedure. The primary outcome-opioid oversupply-was defined as the number of patients with either filled but unused opioid prescriptions or unfilled opioid prescriptions. Two reviewers independently screened studies for inclusion, extracted data, and assessed the study quality. Six eligible studies reported on a total of 810 unique patients (range, 30-250 patients) who underwent 7 different types of surgical procedures. Across the 6 studies, 67% to 92% of patients reported unused opioids. Of all the opioid tablets obtained by surgical patients, 42% to 71% went unused. Most patients stopped or used no opioids owing to adequate pain control, and 16% to 29% of patients reported opioid-induced adverse effects. In 2 studies examining storage safety, 73% to 77% of patients reported that their prescription opioids were not stored in locked containers. All studies reported low rates of anticipated or actual disposal, but no study reported US Food and Drug Administration-recommended disposal methods in more than 9% of patients. Postoperative prescription opioids often go unused, unlocked, and undisposed, suggesting an important reservoir of opioids contributing to nonmedical use of these products, which could cause injuries or even deaths.

Systematic review of self-reported cognitive function in cancer patients following chemotherapy treatment.

PubMed

Bray, Victoria J; Dhillon, Haryana M; Vardy, Janette L

2018-05-04

Cognitive symptoms are common in cancer patients, with up to 70% reporting cognitive symptoms following chemotherapy. These symptoms can have a major impact on how an individual functions in all aspects of their lives. This review evaluates self-reported cognitive function and its associations with neuropsychological tests and patient-reported outcomes in adult cancer patients who received chemotherapy treatment for a solid cancer. A search of multiple databases (Medline, Ovid at Nursing, PsycINFO, Allied and Complementary Medicine) from 1936 to 2017 was conducted, identifying 1563 unique articles, of which 101 met inclusion criteria. Of the 101 included studies, 48 (47%) were cross-sectional and 38 (38%) longitudinal in design, with 12 (12%) randomised controlled trials. A minority (26%) incorporated a healthy control arm in the study design, whilst the majority (79%) were in women with breast cancer. There was diversity in the assessment of self-reported cognitive symptoms. A total of 43 of 44 studies that sought an association between self-reported cognitive function and patient-reported outcomes found a moderate to strong association. Overall, 31 studies showed a lack of association between self-reported cognitive symptoms and neuropsychological results, whilst 14 studies reported a significant association between the two, but the association was often restricted to limited cognitive domains. The review found widespread heterogeneity in the assessment of self-reported cognitive symptoms and consistently absent or weak association with neuropsychological test scores. This research highlights the need for a standardised approach to measurement of self-reported cognitive symptoms in cancer patients.

Patient Expectations and Patient-Reported Outcomes in Surgery: A Systematic Review

PubMed Central

Waljee, Jennifer; McGlinn, Evan P.; Sears, Erika Davis; Chung, Kevin C.

2014-01-01

Background Recent events in healthcare reform have brought national attention to integrating patient experiences and expectations into quality metrics. Few studies have comprehensively evaluated the effect of patient expectations on patient-reported outcomes (PROs) following surgery. The purpose of this study is to systematically review the available literature describing the relationship between patient expectations and postoperative PROs. Methods We performed a search of the literature published prior to November 1, 2012. Articles were included in the review if 1) primary data were presented 2) patient expectations regarding a surgical procedure were measured 3) PROs were measured, and 4) the relationship between patient expectations and PROs was specifically examined. PROs were categorized into five subgroups: satisfaction, quality of life (QOL), disability, mood disorder, and pain. We examined each study to determine the relationship between patient expectations and PROs as well as study quality. Results From the initial literature search yielding 1,708 studies, 60 articles were included. Fulfillment of expectations was associated with improved PROs among 24 studies. Positive expectations were correlated with improved PROs for 28 (47%) studies, and poorer PROs for 9 (15%) studies. Eighteen studies reported that fulfillment of expectations was correlated with improved patient satisfaction, and 10 studies identified that positive expectations were correlated with improved postoperative QOL. Finally, patients with positive preoperative expectations reported less pain (8 studies) and disability (15 studies) compared with patients with negative preoperative expectations. Conclusions Patient expectations are inconsistently correlated with PROs following surgery, and there is no accepted method to capture perioperative expectations. Future efforts to rigorously measure expectations and explore their influence on postoperative outcomes can inform clinicians and policy-makers seeking to integrate PROs into measures of surgical quality. PMID:24787107

Patient Mood and Instrumental Activities of Daily Living in Alzheimer Disease: Relationship Between Patient and Caregiver Reports.

PubMed

Votruba, Kristen L; Persad, Carol; Giordani, Bruno

2015-09-01

This retrospective study investigated the relationship between self-reports and caregiver perceptions of patients' depressive symptoms and the respective ability of these reports to predict instrumental activities of daily living (IADLs) beyond what is accounted for by cognitive abilities in 71 patients with mild Alzheimer disease. Patients completed the Geriatric Depression Scale-Short Form, and caregivers completed the Behavior Rating Scale for Dementia assessing their perception of patients' depressive symptoms. Caregivers also completed IADL items from the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory. Cognitive measures included the Mini-Mental State Examination, Logical Memory from the Wechsler Memory Scale III, and Trail Making Test, Part B. The relationship between self-reported depressive symptoms and caregiver report of patients' depressive symptoms showed a trend toward significance (r = .22, P = .06). Measures of depressive symptoms significantly predicted 12.5% of the variance in IADLs performance, beyond that accounted for by patient demographics and cognitive functioning. Interestingly, patients' reports, rather than caregivers', were particularly useful in this prediction. © The Author(s) 2015.

Throat infections are associated with exacerbation in a substantial proportion of patients with chronic plaque psoriasis

PubMed Central

Thorleifsdottir, Ragna H.; Eysteinsdottir, Jenna H.; Olafsson, Jon H.; Sigurdsson, Martin I.; Johnston, Andrew; Valdimarsson, Helgi; Sigurgeirsson, Bardur

2016-01-01

Streptococcal throat infections are known to trigger or exacerbate psoriasis, and several studies support the benefit of tonsillectomy. To evaluate the potential of tonsillectomy as a treatment, we used a retrospective study-specific questionnaire to assess the proportion of psoriasis patients with sore throat-associated psoriasis exacerbations. Our survey sampled 275 psoriasis patients. 42% of patients with plaque psoriasis reported sore throat-associated psoriasis exacerbations, and 72% of patients with confirmed streptococcal infections reported aggravation. Notably, women and early onset psoriasis patients were more likely to report psoriasis exacerbation after a sore throat (p<0.001, p=0.046 respectively). Other psoriasis aggravation factors were more common in patients with sore throat-associated exacerbations (p<0.01). 49% of tonsillectomized patients reported subsequent improvement and had more frequent sore throat-associated aggravation of psoriasis than patients who did not improve after tonsillectomy (p=0.015). These findings suggest a closer association between sore throats, streptococcal throat infections and plaque psoriasis than previously reported. PMID:26984718

Throat Infections are Associated with Exacerbation in a Substantial Proportion of Patients with Chronic Plaque Psoriasis.

PubMed

Thorleifsdottir, Ragna H; Eysteinsdóttir, Jenna H; Olafsson, Jón H; Sigurdsson, Martin I; Johnston, Andrew; Valdimarsson, Helgi; Sigurgeirsson, Bardur

2016-08-23

Streptococcal throat infections are known to trigger or exacerbate psoriasis, and several studies support the benefit of tonsillectomy. To evaluate the potential of tonsillectomy as a treatment, we used a retrospective study-specific questionnaire to assess the proportion of psoriasis patients with sore throat-associated psoriasis exacerbations. Our survey sampled 275 psoriasis patients. Of patients with plaque psoriasis, 42% reported sore throat-associated psoriasis exacerbations, and of patients with confirmed streptococcal infections, 72% reported aggravation. Notably, women and patients with early onset psoriasis were more likely to report psoriasis exacerbation after a sore throat (p < 0.001, p = 0.046, respectively). Other psoriasis aggravation factors were more common in patients with sore throat-associated exacerbations (p < 0.01). Of tonsillectomized patients, 49% reported subsequent improvement and had more frequent sore throat-associated aggravation of psoriasis than patients who did not improve after tonsillectomy (p = 0.015). These findings suggest a closer association between sore throats, streptococcal throat infections and plaque psoriasis than reported previously.

A prospective study of the feasibility and acceptability of a Web-based, electronic patient-reported outcome system in assessing patient recovery after major gynecologic cancer surgery.

PubMed

Andikyan, Vaagn; Rezk, Youssef; Einstein, M Heather; Gualtiere, Gina; Leitao, Mario M; Sonoda, Yukio; Abu-Rustum, Nadeem R; Barakat, Richard R; Basch, Ethan M; Chi, Dennis S

2012-11-01

The purposes of this study are to evaluate the feasibility of capturing patient-reported outcomes (PROs) electronically and to identify the most common distressing symptoms in women recovering from major gynecologic cancer surgery. This was a prospective, single-arm pilot study. Eligible participants included those scheduled for a laparotomy for presumed or known gynecologic malignancy. Patients completed a Web-based "STAR" (Symptom Tracking and Reporting for Patients) questionnaire once preoperatively and weekly during the 6-week postoperative period. The questionnaire consisted of the patient adaptation of the NCI CTCAE 3.0 and EORTC QLQ-C30 3.0. When a patient submitted a response that was concerning, an automated email alert was sent to the clinician. The patient's assessment of STAR's usefulness was measured via an exit survey. Forty-nine patients completed the study. The procedures included the following: hysterectomy±staging (67%), resection of tumor (22%), salpingo-oophorectomy (6%), and other (4%). Most patients (82%) completed at least 4 sessions in STAR. The CTC generated 43 alerts. These alerts resulted in 25 telephone contacts with patients, 2 ER referrals, one new appointment, and one pharmaceutical prescription. The 3 most common patient-reported symptoms generating an alert were as follows: poor performance status (19%), nausea (18%), and fatigue (17%). Most patients found STAR useful (80%) and would recommend it to others (85%). Application of a Web-based, electronic STAR system is feasible in the postoperative period, highly accepted by patients, and warrants further study. Poor performance status, nausea, and fatigue were the most common distressing patient-reported symptoms. Copyright © 2012 Elsevier Inc. All rights reserved.

Physical Therapists' Ability to Identify Psychological Factors and Their Self-Reported Competence to Manage Chronic Low Back Pain.

PubMed

Brunner, Emanuel; Dankaerts, Wim; Meichtry, André; O'Sullivan, Kieran; Probst, Michel

2018-06-01

In the management of chronic low back pain (LBP), identifying and managing more patients who are at high risk and who have psychological barriers to recovery is important yet difficult. The objective of this study was to test physical therapists' ability to allocate patients into risk stratification groups, test correlations between therapists' assessments of psychological factors and patient questionnaires, and explore relationships between psychological factors and therapists' self-reported competence to manage patients with chronic LBP. This was a pragmatic, observational study. Patients completed the STarT Back Tool (SBT, for risk stratification), the Four-Dimensional Symptom Questionnaire (distress, depression, anxiety), and the Tampa Scale of Kinesiophobia (kinesiophobia) prior to the intake session. After this session, physical therapists estimated patient prognostic risk using the 3 SBT categories and rated patient psychological factors using a 0-to-10 scale. Finally, therapists reported their self-reported competence to manage the patient. Intraclass and Spearman rank correlations tested correlations between therapists' intuitive assessments and patient questionnaires. A linear-mixed model explored relationships between psychological factors and therapists' self-reported competence. Forty-nine patients were managed by 20 therapists. Therapists accurately estimated SBT risk allocation in only 41% of patients. Correlations between therapist perceptions and patient questionnaires were moderate for distress (r = 0.602) and fair for depression (r = 0.304) and anxiety (r = 0.327). There was no correlation for kinesiophobia (r = -0.007). Patient distress was identified as a negative predictor of therapists' self-reported competence. This was a cross-sectional study, conducted in only 1 center. Physical therapists were not very accurate at allocating patients into risk stratification groups or identifying psychological factors. Therapists' self-reported competence in managing patients was lowest when patients reported higher distress.

Autograft versus nonirradiated allograft tissue for anterior cruciate ligament reconstruction: a systematic review.

PubMed

Mariscalco, Michael W; Magnussen, Robert A; Mehta, Divyesh; Hewett, Timothy E; Flanigan, David C; Kaeding, Christopher C

2014-02-01

An autograft has traditionally been the gold standard for anterior cruciate ligament reconstruction (ACLR), but the use of allograft tissue has increased in recent years. While numerous studies have demonstrated that irradiated allografts are associated with increased failure rates, some report excellent results after ACLR with nonirradiated allografts. The purpose of this systematic review was to determine whether the use of nonirradiated allograft tissue is associated with poorer outcomes when compared with autografts. Patients undergoing ACLR with autografts versus nonirradiated allografts will demonstrate no significant differences in graft failure risk, laxity on postoperative physical examination, or differences in patient-oriented outcome scores. Systematic review. A systematic review was performed to identify prospective or retrospective comparative studies (evidence level 1, 2, or 3) of autografts versus nonirradiated allografts for ACLR. Outcome data included graft failure based on clinical findings and instrumented laxity, postoperative laxity on physical examination, and patient-reported outcome scores. Studies were excluded if they did not specify whether the allograft had been irradiated. Quality assessment and data extraction were performed by 2 examiners. Nine studies comparing autografts and nonirradiated allografts were included. Six of the 9 studies compared bone-patellar tendon-bone (BPTB) autografts with BPTB allografts. Two studies compared hamstring tendon autografts to hamstring tendon allografts, and 1 study compared hamstring tendon autografts to tibialis anterior allografts. The mean patient age in 7 of 9 studies ranged from 24.5 to 32 years, with 1 study including only patients older than 40 years and another not reporting patient age. The mean follow-up duration was 24 to 94 months. Six of 9 studies reported clinical graft failure rates, 8 of 9 reported postoperative instrumented laxity measurements, 7 of 9 reported postoperative physical examination findings, and all studies reported patient-reported outcome scores. This review demonstrated no statistically significant difference between autografts and nonirradiated allografts in any outcome measure. No significant differences were found in graft failure rate, postoperative laxity, or patient-reported outcome scores when comparing ACLR with autografts to nonirradiated allografts in this systematic review. These findings apply to patients in their late 20s and early 30s. Caution is advised when considering extrapolation of these findings to younger, more active cohorts.

The influence of media reporting of a celebrity suicide on suicidal behavior in patients with a history of depressive disorder.

PubMed

Cheng, Andrew T A; Hawton, Keith; Chen, Tony H H; Yen, Amy M F; Chang, Jung-Chen; Chong, Mian-Yoon; Liu, Chia-Yih; Lee, Yu; Teng, Po-Ren; Chen, Lin-Chen

2007-11-01

Few studies have directly assessed the impact of a specific media report in vulnerable people. This study investigates possible influences of media reporting of a celebrity suicide on subsequent suicidal behaviors and associated risk factors among depressive patients. Depressive patients (N=461) were assessed through a structured interview soon after extensive media reporting of a celebrity suicide. Among 438 depressive patients exposed to the media report, 38.8% reported an influence on subsequent suicidal behaviors, including 24 (5.5%) with a suicide attempt. The risk of such influence was highest among patients in a severe depressive state just prior to the media report (adjusted OR 7.81, 95% CI 3.28-18.59). Such influence on a subsequent suicide attempt was highest in patients with a most recent suicide attempt within one month prior to the media reports (adjusted hazard ratio 11.91, 95% CI 3.76-37.72). Our finding of the significant media influence may reflect adverse thoughts among more suicidal and depressed individuals. The possible influence of other factors on the findings cannot be ruled out. This study has provided more convincing evidence suggesting negative influences of media reporting of a celebrity suicide on subsequent suicidal behaviors among depressive patients. Particular attention in terms of potential negative media influences should be paid to patients who are younger and currently depressed and have made a recent suicide attempt.

Clinical Outcome Reporting in Youth ACL Literature Is Widely Variable

PubMed Central

Brusalis, Christopher M.; Lakomkin, Nikita; Suryavanshi, Joash R.; Cruz, Aristides I.; Green, Daniel W.; Jones, Kristofer J.; Fabricant, Peter D.

2017-01-01

Background: Advances in anterior cruciate ligament (ACL) reconstruction procedures in pediatric and adolescent patients have resulted in an increase in recent clinical studies on this topic. However, the consistency with which outcome measures are reported in this demographic is unknown. Purpose: To document outcome reporting patterns of youth ACL reconstruction studies in high-impact journals. Study Design: Systematic review; Level of evidence, 4. Methods: All articles published in 5 high-impact orthopaedic journals from 2010 to 2016 were reviewed to identify those reporting clinical outcomes of young patients who underwent ACL reconstruction. Studies that were nonclinical, reported on patients older than 18 years, or included fewer than 10 patients were excluded. Outcome measures used in all included studies were recorded. Results: Seventeen studies encompassing 772 subjects (mean age, 14.3 years; range, 6.3-18.0 years) were analyzed. Eight studies (47%) reported on Tanner stage of subjects, while 1 study reported skeletal age. Ten studies (59%) clearly documented the presence or absence of surgical complications. Range of motion was reported in 65% of studies. Leg-length discrepancy and angular deformity were each reported in 76% of studies, with 12% quantifying results through radiographic measurements. Ligament testing was variably defined by inclusion of instrumented testing (65%), Lachman test (53%), and pivot-shift test (53%). Fourteen studies (82%) explicitly reported on the rate of ACL rerupture, while 71% reported on the rate of revision surgery. Rate of return to preinjury activity was reported in 8 studies (47%), of which 2 defined criteria for return to sport and 3 defined the level of competitive sport. Patient-reported outcome measures (PROMs) were used variably. For the 3 most commonly reported PROMs (Lysholm, International Knee Documentation Committee, and Tegner), 24% of studies reported all 3 PROMs, 35% of studies reported 2 PROMs, and 6% of studies reported 1 PROM in isolation. A pediatric-specific PROM was reported in 1 of the 17 studies. Conclusion: Studies on pediatric ACL reconstruction published in high-impact journals unreliably defined subjects’ skeletal maturity, inconsistently reported on objective outcome measures, and used disparate adult-validated PROMs to assess subjective outcomes. These findings highlight the need for standardized, pediatric-specific outcome measures to be applied in future studies evaluating ACL reconstruction in children and adolescents. PMID:28840156

Patient characteristics associated with the level of patient-reported care coordination among male patients with colorectal cancer in the Veterans Affairs health care system.

PubMed

Jackson, George L; Zullig, Leah L; Phelan, Sean M; Provenzale, Dawn; Griffin, Joan M; Clauser, Steven B; Haggstrom, David A; Jindal, Rahul M; van Ryn, Michelle

2015-07-01

The current study was performed to determine whether patient characteristics, including race/ethnicity, were associated with patient-reported care coordination for patients with colorectal cancer (CRC) who were treated in the Veterans Affairs (VA) health care system, with the goal of better understanding potential goals of quality improvement efforts aimed at improving coordination. The nationwide Cancer Care Assessment and Responsive Evaluation Studies survey involved VA patients with CRC who were diagnosed in 2008 (response rate, 67%). The survey included a 4-item scale of patient-reported frequency ("never," "sometimes," "usually," and "always") of care coordination activities (scale score range, 1-4). Among 913 patients with CRC who provided information regarding care coordination, demographics, and symptoms, multivariable logistic regression was used to examine odds of patients reporting optimal care coordination. VA patients with CRC were found to report high levels of care coordination (mean scale score, 3.50 [standard deviation, 0.61]). Approximately 85% of patients reported a high level of coordination, including the 43% reporting optimal/highest-level coordination. There was no difference observed in the odds of reporting optimal coordination by race/ethnicity. Patients with early-stage disease (odds ratio [OR], 0.60; 95% confidence interval [95% CI], 0.45-0.81), greater pain (OR, 0.97 for a 1-point increase in pain scale; 95% CI, 0.96-0.99), and greater levels of depression (OR, 0.97 for a 1-point increase in depression scale; 95% CI, 0.96-0.99) were less likely to report optimal coordination. Patients with CRC in the VA reported high levels of care coordination. Unlike what has been reported in settings outside the VA, there appears to be no racial/ethnic disparity in reported coordination. However, challenges remain in ensuring coordination of care for patients with less advanced disease and a high symptom burden. Cancer 2015;121:2207-2213. © 2015 American Cancer Society. © 2015 American Cancer Society.

A time-motion study of ambulance-to-emergency department radio communications.

PubMed

Penner, Mark S; Cone, David C; MacMillan, Don

2003-01-01

A prospective time-motion study of radio communication between inbound ambulances and emergency department (ED) triage personnel was conducted to assess hospital triage staff time utilized, and how often radio reports result in actions taken in the ED to prepare for patient arrival. The study hypothesis was that reports for "priority 2" (P2, nonemergent) patients rarely provide information that is acted upon in the ED prior to the patient's arrival. The study was conducted at an academic adult ED receiving 22,000 ambulances per year. An observer in the ED monitored and timed (to the second) all radio reports as well as the activities of triage nurses and arriving emergency medical services (EMS) personnel. A convenience sample of 437 reports was collected: 83 priority 1 (P1, emergent) and 354 P2. Average report times (minutes:seconds) with ranges were 0:53 (0:07-1:57) for P1, and 0:44 (0:04-3:50) for P2. Only 16% of the P2 reports resulted in any preparatory action, and 55% of these were requests to have hospital police officers available to receive intoxicated patients, as per local protocol. An in-person report was given in the ED for 61% of the P2 cases, and in 48% of these, the in-person report was longer than the radio report. In the system studied, P2 reports rarely provide information that is acted on prior to the patient's arrival. The time spent giving a radio report is frequently duplicated in the ED. Radio reports for low-priority patients may not be an efficient or productive use of providers' or nurses' time.

How Are We Measuring Patient Satisfaction After Anterior Cruciate Ligament Reconstruction?

PubMed Central

Kahlenberg, Cynthia A.; Nwachukwu, Benedict U.; Ferraro, Richard A.; Schairer, William W.; Steinhaus, Michael E.; Allen, Answorth A.

2016-01-01

Background: Reconstruction of the anterior cruciate ligament (ACL) is one of the most common orthopaedic operations in the United States. The long-term impact of ACL reconstruction is controversial, however, as longer term data have failed to demonstrate that ACL reconstruction helps alter the natural history of early onset osteoarthritis that occurs after ACL injury. There is significant interest in evaluating the value of ACL reconstruction surgeries. Purpose: To examine the quality of patient satisfaction reporting after ACL reconstruction surgery. Study Design: Systematic review; Level of evidence, 4. Methods: A systematic review of the MEDLINE database was performed using the PubMed interface. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines as well as the PRISMA checklist were employed. The initial search yielded 267 studies. The inclusion criteria were: English language, US patient population, clinical outcome study of ACL reconstruction surgery, and reporting of patient satisfaction included in the study. Study quality was assessed using the Newcastle-Ottawa scale. Results: A total of 22 studies met the inclusion criteria. These studies comprised a total of 1984 patients with a mean age of 31.9 years at the time of surgery and a mean follow-up period of 59.3 months. The majority of studies were evidence level 4 (n = 18; 81.8%), had a mean Newcastle-Ottawa scale score of 5.5, and were published before 2006 (n = 17; 77.3%); 5 studies (22.7%) failed to clearly describe their method for determining patient satisfaction. The most commonly used method for assessing satisfaction was a 0 to 10 satisfaction scale (n = 11; 50.0%). Among studies using a 0 to 10 scale, mean satisfaction ranged from 7.4 to 10.0. Patient-reported outcome and objective functional measures for ACL stability and knee function were positively correlated with patient satisfaction. Degenerative knee change was negatively correlated with satisfaction. Conclusion: The level of evidence for studies reporting patient satisfaction is low, and the methodologies for reporting patient satisfaction are variable. Additionally, within the past decade there has been a significant decline in the inclusion of this outcome measure within published ACL studies. As sports surgeons are increasingly called on to demonstrate the value of operative procedures, attention should be paid to understanding and reporting patient satisfaction. PMID:28203583

Language barriers and patient safety risks in hospital care. A mixed methods study.

PubMed

van Rosse, Floor; de Bruijne, Martine; Suurmond, Jeanine; Essink-Bot, Marie-Louise; Wagner, Cordula

2016-02-01

A language barrier has been shown to be a threat for quality of hospital care. International studies highlighted a lack of adequate noticing, reporting, and bridging of a language barrier. However, studies on the link between language proficiency and patient safety are scarce, especially in Europe. The present study investigates patient safety risks due to language barriers during hospitalization, and the way language barriers are detected, reported, and bridged in Dutch hospital care. We combined quantitative and qualitative methods in a sample of 576 ethnic minority patients who were hospitalized on 30 wards within four urban hospitals. The nursing and medical records of 17 hospital admissions of patients with language barriers were qualitatively analyzed, and complemented by 12 in-depth interviews with care providers and patients and/or their relatives to identify patient safety risks during hospitalization. The medical records of all 576 patients were screened for language barrier reports. The results were compared to patients' self-reported Dutch language proficiency. The policies of wards regarding bridging language barriers were compared with the reported use of interpreters in the medical records. Situations in hospital care where a language barrier threatened patient safety included daily nursing tasks (i.e. medication administration, pain management, fluid balance management) and patient-physician interaction concerning diagnosis, risk communication and acute situations. In 30% of the patients that reported a low Dutch proficiency, no language barrier was documented in the patient record. Relatives of patients often functioned as interpreter for them and professional interpreters were hardly used. The present study showed a wide variety of risky situations in hospital care for patients with language barriers. These risks can be reduced by adequately bridging the language barrier, which, in the first place, demands adequate detecting and reporting of a language barrier. This is currently not sufficiently done in most Dutch hospitals. Moreover, new solutions to bridge language barriers are needed for situations such as routine safety checks performed by nurses, in which a professional or even informal interpreter is not feasible. Copyright © 2015 Elsevier Ltd. All rights reserved.

Sensitivity of self-reported opioid use in case-control studies: Healthy individuals versus hospitalized patients.

PubMed

Rashidian, Hamideh; Hadji, Maryam; Marzban, Maryam; Gholipour, Mahin; Rahimi-Movaghar, Afarin; Kamangar, Farin; Malekzadeh, Reza; Weiderpass, Elisabete; Rezaianzadeh, Abbas; Moradi, Abdolvahab; Babhadi-Ashar, Nima; Ghiasvand, Reza; Khavari-Daneshvar, Hossein; Haghdoost, Ali Akbar; Zendehdel, Kazem

2017-01-01

Several case-control studies have shown associations between the risk of different cancers and self-reported opium use. Inquiring into relatively sensitive issues, such as the history of drug use, is usually prone to information bias. However, in order to justify the findings of these types of studies, we have to quantify the level of such a negative bias. In current study, we aimed to evaluate sensitivity of self-reported opioid use and suggest suitable types of control groups for case-control studies on opioid use and the risk of cancer. In order to compare the validity of the self-reported opioid use, we cross-validated the response of two groups of subjects 1) 178 hospitalized patients and 2) 186 healthy individuals with the results of their tests using urine rapid drug screen (URDS) and thin layer chromatography (TLC). The questioners were asked by trained interviewers to maximize the validity of responses; healthy individuals were selected from the companions of patients in hospitals. Self-reported regular opioid use was 36.5% in hospitalized patients 19.3% in healthy individuals (p-value> 0.001).The reported frequencies of opioid use in the past 72 hours were 21.4% and 11.8% in hospitalized patients and healthy individuals respectively. Comparing their responses with the results of urine tests showed a sensitivity of 77% and 69% among hospitalized patients and healthy individuals for self-reports (p-value = 0.4). Having corrected based on the mentioned sensitivities; the frequency of opioid regular use was 47% and 28% in hospitalized patients and healthy individuals, respectively. Regular opioid use among hospitalized patients was significantly higher than in healthy individuals (p-value> 0.001). Our findings showed that the level of opioid use under-reporting in hospitalized patients and healthy individuals was considerable but comparable. In addition, the frequency of regular opioid use among hospitalized patients was significantly higher than that in the general population. Altogether, it seems that, without corrections for these differences and biases, the results of many studies including case-control studies on opioid use might distort findings substantially.

Sensitivity of self-reported opioid use in case-control studies: Healthy individuals versus hospitalized patients

PubMed Central

Rashidian, Hamideh; Hadji, Maryam; Marzban, Maryam; Gholipour, Mahin; Rahimi-Movaghar, Afarin; Kamangar, Farin; Malekzadeh, Reza; Weiderpass, Elisabete; Rezaianzadeh, Abbas; Moradi, Abdolvahab; Babhadi-Ashar, Nima; Ghiasvand, Reza; Khavari-Daneshvar, Hossein; Haghdoost, Ali Akbar; Zendehdel, Kazem

2017-01-01

Background Several case-control studies have shown associations between the risk of different cancers and self-reported opium use. Inquiring into relatively sensitive issues, such as the history of drug use, is usually prone to information bias. However, in order to justify the findings of these types of studies, we have to quantify the level of such a negative bias. In current study, we aimed to evaluate sensitivity of self-reported opioid use and suggest suitable types of control groups for case-control studies on opioid use and the risk of cancer. Methods In order to compare the validity of the self-reported opioid use, we cross-validated the response of two groups of subjects 1) 178 hospitalized patients and 2) 186 healthy individuals with the results of their tests using urine rapid drug screen (URDS) and thin layer chromatography (TLC). The questioners were asked by trained interviewers to maximize the validity of responses; healthy individuals were selected from the companions of patients in hospitals. Results Self-reported regular opioid use was 36.5% in hospitalized patients 19.3% in healthy individuals (p-value> 0.001).The reported frequencies of opioid use in the past 72 hours were 21.4% and 11.8% in hospitalized patients and healthy individuals respectively. Comparing their responses with the results of urine tests showed a sensitivity of 77% and 69% among hospitalized patients and healthy individuals for self-reports (p-value = 0.4). Having corrected based on the mentioned sensitivities; the frequency of opioid regular use was 47% and 28% in hospitalized patients and healthy individuals, respectively. Regular opioid use among hospitalized patients was significantly higher than in healthy individuals (p-value> 0.001). Conclusion Our findings showed that the level of opioid use under-reporting in hospitalized patients and healthy individuals was considerable but comparable. In addition, the frequency of regular opioid use among hospitalized patients was significantly higher than that in the general population. Altogether, it seems that, without corrections for these differences and biases, the results of many studies including case-control studies on opioid use might distort findings substantially. PMID:28854228

Traumatic stressors and post-traumatic stress disorder symptoms in headache patients.

PubMed

de Leeuw, Reny; Schmidt, John E; Carlson, Charles R

2005-01-01

The aim of this study was to assess the prevalence of significant traumatic stressors and post-traumatic stress disorder (PTSD) symptoms in a headache population. Several recent publications have emphasized the relationship between life stressors and/or daily hassles and recurrent headaches. However, little is known about the prevalence and impact of major traumatic stressors in patients with recurrent headaches. Eighty patients with either migraine or tension-type headache completed a PTSD checklist. Data were compared with those from patients with chronic masticatory muscle pain of similar intensity and duration. Almost 64% of the headache patients reported one or more major traumatic stressors. This percentage was not significantly different from that of the comparison group, and fell within the broad range reported for exposure to traumatic stressors in epidemiologic studies with nonpatient populations. One out of 6 patients in the total headache sample, and 1 out of 4 of those reporting a traumatic stressor, reported symptoms suggestive of current PTSD. The prevalence of current PTSD-like symptomatology reported by the headache patients was comparable to that of the comparison group of the present study, but higher than that reported for the general population in the available literature printed in English. Traumatic stressors most often reported were not related to direct physical trauma, but rather associated with loss or serious illness of a loved one. Exposure to traumatic events in patients with a primary diagnosis of recurrent headaches is similar to that reported for chronic masticatory muscle pain patients or nonpatient populations. However, symptoms consistent with a diagnosis of current PTSD appear to be more frequent in patients with recurrent headaches than reported in the scientific literature printed in English for nonpatient populations. Screening for PTSD symptomatology is recommended as part of the routine clinical evaluation of headache.

Influence of opioid-related side effects on disability, mood, and opioid misuse risk among patients with chronic pain in primary care.

PubMed

Jamison, Robert N; Dorado, Kathleen; Mei, Anna; Edwards, Robert R; Martel, Marc O

2017-03-01

There is increasing concern among primary care practitioners about the use of opioids for chronic pain, including their adverse effects, but little attention has been given to how reports of side effects from prescription medication can contribute to outcomes among patients with chronic pain. The aim of this study was to investigate the impact of frequently reported side effects on mood, disability, and opioid misuse in patients with chronic pain prescribed opioids within primary care. Two hundred (N = 200) patients with chronic pain taking opioids for pain were recruited into the study. All patients completed baseline measures and a monthly side effects checklist once a month for 6 months. Patients were divided evenly based on a median split of the number of endorsed side effects over 6 months. The subjects repeated the baseline measures at the end of the study period. Over time, reports of medication side effects tended to decrease, but differences in frequency of reported side effects from baseline to follow-up (6-month time) were not significant, and the order of the frequency of the reported side effects remained similar. Patients who reported significant medication-related adverse effects reported significantly greater activity interference, negative affect, and catastrophizing compared with those with fewer side effects ( P < 0.01). In addition, those patients with pain who reported more side effects showed significantly higher scores on opioid misuse risk ( P < 0.001). This study demonstrates the important role of monitoring medication-related side effects among patients with chronic pain who are prescribed opioid medication for pain within primary care.

Influence of opioid-related side effects on disability, mood, and opioid misuse risk among patients with chronic pain in primary care

PubMed Central

Jamison, Robert N.; Dorado, Kathleen; Mei, Anna; Edwards, Robert R.; Martel, Marc O.

2017-01-01

Abstract Background: There is increasing concern among primary care practitioners about the use of opioids for chronic pain, including their adverse effects, but little attention has been given to how reports of side effects from prescription medication can contribute to outcomes among patients with chronic pain. The aim of this study was to investigate the impact of frequently reported side effects on mood, disability, and opioid misuse in patients with chronic pain prescribed opioids within primary care. Methods: Two hundred (N = 200) patients with chronic pain taking opioids for pain were recruited into the study. All patients completed baseline measures and a monthly side effects checklist once a month for 6 months. Patients were divided evenly based on a median split of the number of endorsed side effects over 6 months. The subjects repeated the baseline measures at the end of the study period. Results: Over time, reports of medication side effects tended to decrease, but differences in frequency of reported side effects from baseline to follow-up (6-month time) were not significant, and the order of the frequency of the reported side effects remained similar. Patients who reported significant medication-related adverse effects reported significantly greater activity interference, negative affect, and catastrophizing compared with those with fewer side effects (P < 0.01). In addition, those patients with pain who reported more side effects showed significantly higher scores on opioid misuse risk (P < 0.001). Discussion: This study demonstrates the important role of monitoring medication-related side effects among patients with chronic pain who are prescribed opioid medication for pain within primary care. PMID:29392205

High Variability in Outcome Reporting Patterns in High-Impact ACL Literature.

PubMed

Makhni, Eric C; Padaki, Ajay S; Petridis, Petros D; Steinhaus, Michael E; Ahmad, Christopher S; Cole, Brian J; Bach, Bernard R

2015-09-16

ACL (anterior cruciate ligament) reconstruction is one of the most commonly performed and studied procedures in modern sports medicine. A multitude of objective and subjective patient outcome measures exists; however, nonstandardized reporting patterns of these metrics may create challenges in objectively analyzing pooled results from different studies. The goal of this study was to document the variability in outcome reporting patterns in high-impact orthopaedic studies of ACL reconstruction. All clinical studies pertaining to ACL reconstruction in four high-impact-factor orthopaedic journals over a five-year period were reviewed. Biomechanical, basic science, and imaging studies were excluded, as were studies with fewer than fifty patients, yielding 119 studies for review. Incorporation of various objective and subjective outcomes was noted for each study. Substantial variability in reporting of both objective and subjective measures was noted in the study cohort. Although a majority of studies reported instrumented laxity findings, there was substantial variability in the type and method of laxity reporting. Most other objective outcomes, including range of motion, strength, and complications, were reported in <50% of all studies. Return to pre-injury level of activity was infrequently reported (24% of studies), as were patient satisfaction and pain assessment following surgery (8% and 13%, respectively). Of the patient-reported outcomes, the International Knee Documentation Committee (IKDC), Lysholm, and Tegner scores were most often reported (71%, 63%, and 42%, respectively). Substantial variability in outcome reporting patterns exists among high-impact studies of ACL reconstruction. Such variability may create challenges in interpreting results and pooling them across different studies. Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.

How Are We Measuring Patient Satisfaction After Anterior Cruciate Ligament Reconstruction?

PubMed

Kahlenberg, Cynthia A; Nwachukwu, Benedict U; Ferraro, Richard A; Schairer, William W; Steinhaus, Michael E; Allen, Answorth A

2016-12-01

Reconstruction of the anterior cruciate ligament (ACL) is one of the most common orthopaedic operations in the United States. The long-term impact of ACL reconstruction is controversial, however, as longer term data have failed to demonstrate that ACL reconstruction helps alter the natural history of early onset osteoarthritis that occurs after ACL injury. There is significant interest in evaluating the value of ACL reconstruction surgeries. To examine the quality of patient satisfaction reporting after ACL reconstruction surgery. Systematic review; Level of evidence, 4. A systematic review of the MEDLINE database was performed using the PubMed interface. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines as well as the PRISMA checklist were employed. The initial search yielded 267 studies. The inclusion criteria were: English language, US patient population, clinical outcome study of ACL reconstruction surgery, and reporting of patient satisfaction included in the study. Study quality was assessed using the Newcastle-Ottawa scale. A total of 22 studies met the inclusion criteria. These studies comprised a total of 1984 patients with a mean age of 31.9 years at the time of surgery and a mean follow-up period of 59.3 months. The majority of studies were evidence level 4 (n = 18; 81.8%), had a mean Newcastle-Ottawa scale score of 5.5, and were published before 2006 (n = 17; 77.3%); 5 studies (22.7%) failed to clearly describe their method for determining patient satisfaction. The most commonly used method for assessing satisfaction was a 0 to 10 satisfaction scale (n = 11; 50.0%). Among studies using a 0 to 10 scale, mean satisfaction ranged from 7.4 to 10.0. Patient-reported outcome and objective functional measures for ACL stability and knee function were positively correlated with patient satisfaction. Degenerative knee change was negatively correlated with satisfaction. The level of evidence for studies reporting patient satisfaction is low, and the methodologies for reporting patient satisfaction are variable. Additionally, within the past decade there has been a significant decline in the inclusion of this outcome measure within published ACL studies. As sports surgeons are increasingly called on to demonstrate the value of operative procedures, attention should be paid to understanding and reporting patient satisfaction.

Is perceived family dysfunction related to comorbid psychopathology? A study at an eating disorder day treatment program.

PubMed

Wisotsky, Willo; Dancyger, Ida; Fornari, Victor; Swencionis, Charles; Fisher, Martin; Schneider, Marcie; Wisotsky, William

2006-01-01

The role of the family in the development of eating disorders has been a predominant research focus. However, few studies of patients in an eating disorder (ED) day treatment program (DTP) have explored the relationship between self-reported family system functioning, self-reported comorbid psychopathology and current comorbid psychological symptom status. This study examined patients at presentation to an ED DTP, their self-reported perception of family functioning and the relationship with characteristics of their own comorbid psychopathology characteristics. Medical records of 51 day treatment female patients, ranging in age from 12 to 26 years, were examined by ED diagnosis and family type (using the FACES-II), and for significant differences on four self-report measures: SCL-90, EDI-2, BDI and TAS-20. Using MANOVA analyses and Bonferroni comparisons, significant differences on the self-report instruments for the entire sample and for the AN and BN patients were obtained when studying patients within different family types as defined by FACES-II. These data specific to DTP patients support previous findings for both IP and OP ED family studies. Overall, as family functioning was perceived to be more dysfunctional, the level of self-reported eating pathology and current comorbid psychological symptoms was also more severe.

Assessing quality of life in a clinical study on heart rehabilitation patients: how well do value sets based on given or experienced health states reflect patients' valuations?

PubMed

Leidl, Reiner; Schweikert, Bernd; Hahmann, Harry; Steinacker, Juergen M; Reitmeir, Peter

2016-03-22

Quality of life as an endpoint in a clinical study may be sensitive to the value set used to derive a single score. Focusing on patients' actual valuations in a clinical study, we compare different value sets for the EQ-5D-3L and assess how well they reproduce patients' reported results. A clinical study comparing inpatient (n = 98) and outpatient (n = 47) rehabilitation of patients after an acute coronary event is re-analyzed. Value sets include: 1. Given health states and time-trade-off valuation (GHS-TTO) rendering economic utilities; 2. Experienced health states and valuation by visual analog scale (EHS-VAS). Valuations are compared with patient-reported VAS rating. Accuracy is assessed by mean absolute error (MAE) and by Pearson's correlation ρ. External validity is tested by correlation with established MacNew global scores. Drivers of differences between value sets and VAS are analyzed using repeated measures regression. EHS-VAS had smaller MAEs and higher ρ in all patients and in the inpatient group, and correlated best with MacNew global score. Quality-adjusted survival was more accurately reflected by EHS-VAS. Younger, better educated patients reported lower VAS at admission than the EHS-based value set. EHS-based estimates were mostly able to reproduce patient-reported valuation. Economic utility measurement is conceptually different, produced results less strongly related to patients' reports, and resulted in about 20 % longer quality-adjusted survival. Decision makers should take into account the impact of choosing value sets on effectiveness results. For transferring the results of heart rehabilitation patients from another country or from another valuation method, the EHS-based value set offers a promising estimation option for those decision makers who prioritize patient-reported valuation. Yet, EHS-based estimates may not fully reflect patient-reported VAS in all situations.

Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study.

PubMed

Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn; Lundh, Andreas; Gøtzsche, Peter C

2014-06-04

To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical coding dictionary used, and the patient's trial identification number. Using the patient's trial identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report. 9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency for marketing approval. Clinical study reports obtained from the EMA in 2011. Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly identifiable in all formats of adverse event data in clinical study reports. Suicide attempts presented in tables included both definitive and provisional diagnoses. Suicidal ideation and preparatory behaviour were obscured in some tables owing to the lack of specificity of the medical coding dictionary, especially COSTART. Furthermore, we found one event of suicidal ideation described in narrative text that was absent from tables and adverse event listings of individual patients. The reason for this is unclear, but may be due to the coding conventions used. Data on adverse events in tables in clinical study reports may not accurately represent the underlying patient data because of the medical dictionaries and coding conventions used. In clinical study reports, the listings of adverse events for individual patients and narratives of adverse events can provide additional information, including original investigator reported adverse event terms, which can enable a more accurate estimate of harms. © Maund et al 2014.

Patient-provider communication about sexual concerns in cancer: a systematic review.

PubMed

Reese, Jennifer Barsky; Sorice, Kristen; Beach, Mary Catherine; Porter, Laura S; Tulsky, James A; Daly, Mary B; Lepore, Stephen J

2017-04-01

Cancer survivors' needs around sexual concerns are often unmet. The primary objective of this systematic review was to examine the prevalence of and factors associated with patient-provider communication about sexual concerns in cancer. Using PRISMA guidelines, we searched PubMed/MEDLINE, PsychInfo, and CINAHL databases for peer-reviewed quantitative research papers (2000-2015) in cancer samples. Search terms across three linked categories were used (sexuality, communication, and cancer). The National Comprehensive Cancer Network (NCCN) Sexual Function Guidelines were used as a framework to categorize communication reported in each study. Twenty-nine studies from 10 countries (29 % in USA) were included. Studies assessed patients only (21), providers only (4), and both (4). Communication measures differed across studies and many lacked validity data. When reported by patients or providers, the average prevalence of discussing potential treatment effects on sexual function was 50 (60 % for men and 28 % for women) and 88 %, respectively. As reported by patients or providers, respectively, assessing patients' sexual concerns (10 and 21 %) and offering treatments (22 and 17 %) were measured in fewer studies and were reported less frequently. Both patients and providers (28 and 32 %, respectively) reported a low prevalence of other non-specific communication. Greater prevalence of communication was associated with male patient gender and more years of provider experience. Sexual issues go unaddressed for many cancer survivors, particularly women. Both patient and provider interventions are needed. Enhancing patient-provider communication about sexual concerns through evidence-based interventions could improve patient sexual function and quality of life.

Frequency of reporting and predictive factors for anxiety and depression in patients with advanced cancer.

PubMed

Salvo, N; Zeng, L; Zhang, L; Leung, M; Khan, L; Presutti, R; Nguyen, J; Holden, L; Culleton, S; Chow, E

2012-03-01

The prevalence of anxiety and depression in patients with advanced cancer has been reported to be on average 25% and to significantly affect patients' quality of life. Despite high prevalence rates, these disorders remain underdiagnosed and undertreated. The purpose of our study was to examine the self-report rates of anxiety and depression with the Edmonton Symptom Assessment System (ESAS) and to assess the predictive factors for these reports in cancer patients with metastatic disease. Consecutive patients who attended the Rapid Response Radiotherapy Program (RRRP) completed the ESAS as well as baseline demographic information. Ordinal logistic regression analysis was used to determine factors that significantly predicted anxiety and/or depression. Pearson χ(2) was used to test goodness-of-fit for categorical variables and established whether or not an observed frequency distribution differed from a predicted frequency distribution. A univariate analysis was conducted first and those variables with a P value<0.100 were included in a multivariate analysis. A score test was used to test the proportional odds assumption. In total, 1439 patients seen in the RRRP between January 1999 and October 2009 completed ESAS questionnaires. Fifty-five per cent of patients reported at least mild symptoms of depression and 65% reported at least mild anxiety. In the univariate analysis, patients who were female, who had a lower performance status score, or primary lung cancer were more likely to report depressed and anxious feelings. Primary prostate cancer patients were significantly less likely to report depression and anxiety. Patients referred for spinal cord compression were significantly less depressed. The multivariate models showed that younger patients were significantly more anxious than older patients and females reported more anxiety than males. Patients who reported higher feelings of nausea, tiredness, drowsiness, dyspnoea, and worse appetite and overall well-being on the ESAS tool were more likely to report feelings of depression. Patients who reported higher nausea, drowsiness, dyspnoea and worse overall well-being more often reported higher feelings of anxiety. The self-report rates of anxiety and depression were consistent with published prevalence rates. However, the explained variance based on factors included in the model remains low. Additional predictive factors should be examined in future studies in this population. The ESAS tool seems to be an efficient screening tool for anxiety and depression; however, future studies should examine its correlative properties with other known screening tools in the advanced cancer population. A prospective study should be conducted to assess the severity cut-off point in which the ESAS scores most frequently lead to a further diagnosis of an anxiety or depressive disorder in the advance cancer population. Copyright © 2011 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

Systematic review on the treatment of isolated local recurrence of pancreatic cancer after surgery; re-resection, chemoradiotherapy and SBRT.

PubMed

Groot, Vincent P; van Santvoort, Hjalmar C; Rombouts, Steffi J E; Hagendoorn, Jeroen; Borel Rinkes, Inne H M; van Vulpen, Marco; Herman, Joseph M; Wolfgang, Christopher L; Besselink, Marc G; Molenaar, I Quintus

2017-02-01

The majority of patients who have undergone a pancreatic resection for pancreatic cancer develop disease recurrence within two years. In around 30% of these patients, isolated local recurrence (ILR) is found. The aim of this study was to systematically review treatment options for this subgroup of patients. A systematic search was performed in PubMed, Embase and the Cochrane Library. Studies reporting on the treatment of ILR after initial curative-intent resection of primary pancreatic cancer were included. Primary endpoints were morbidity, mortality and survival after ILR treatment. After screening 1152 studies, 18 studies reporting on 313 patients undergoing treatment for ILR were included. Treatment options for ILR included surgical re-resection (8 studies, 100 patients), chemoradiotherapy (7 studies, 153 patients) and stereotactic body radiation therapy (SBRT) (4 studies, 60 patients). Morbidity and mortality were reported for re-resection (29% and 1%, respectively), chemoradiotherapy (54% and 0%) and SBRT (3% and 1%). Most patients had a prolonged disease-free interval before recurrence. Median survival after treatment of ILR of up to 32, 19 and 16 months was reported for re-resection, chemoradiotherapy and SBRT, respectively. In selected patients, treatment of ILR following pancreatic resection for pancreatic cancer seems safe, feasible and associated with relatively good survival. Copyright © 2016 International Hepato-Pancreato-Biliary Association Inc. Published by Elsevier Ltd. All rights reserved.

Patient-Reported Allergies Predict Worse Outcomes After Hip and Knee Arthroplasty: Results From a Prospective Cohort Study.

PubMed

Otero, Jesse E; Graves, Christopher M; Gao, Yubo; Olson, Tyler S; Dickinson, Christopher C; Chalus, Rhonda J; Vittetoe, David A; Goetz, Devon D; Callaghan, John J

2016-12-01

Retrospective analyses have demonstrated correlation between patient-reported allergies and negative outcomes after total joint arthroplasty. We sought to validate these observations in a prospective cohort. One hundred forty-four patients undergoing total hip arthroplasty and 302 patients undergoing total knee arthroplasty were prospectively enrolled. Preoperatively, patients listed their allergies and completed the Medical Outcomes Study Short Form 36 (SF-36) and the Charlson Comorbidity Index (CCI) Questionnaire. At a mean of 17 months (range 12-25 months) postoperatively, SF-36, CCI, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) were obtained by telephone survey. Regression analysis was used to determine the strength of correlation between patient age, comorbidity burden, and number of allergies and outcome measurements. In 446 patients, 273 reported at least 1 allergy. The number of allergies reported ranged from 0 to 33. Penicillin or its derivative was the most frequently reported allergy followed by sulfa, environmental allergen, and narcotic pain medication. Patients reporting at least 1 allergy had a significantly lower postoperative SF-36 Physical Component Score compared to those reporting no allergies (51.3 vs 49.4, P = .01). The SF-36 postoperative Mental Component Score was no different between groups. Multivariate regression analysis showed that age and patient reported allergies, but not comorbidities, were independently associated with worse postoperative SF-36 Physical Component Summary (PCS) and WOMAC score. Patients with allergies experienced the same improvement in SF-36 PCS as those without an allergy. Comorbidities did not correlate with patient-reported function postoperatively. Patients who report allergies have lower postoperative outcome scores but may experience the same increment in improvement after total joint arthroplasty. Copyright © 2016 Elsevier Inc. All rights reserved.

A quantitative assessment of patient and nurse outcomes of bedside nursing report implementation.

PubMed

Sand-Jecklin, Kari; Sherman, Jay

2014-10-01

To quantify quantitative outcomes of a practice change to a blended form of bedside nursing report. The literature identifies several benefits of bedside nursing shift report. However, published studies have not adequately quantified outcomes related to this process change, having either small or unreported sample sizes or not testing for statistical significance. Quasi-experimental pre- and postimplementation design. Seven medical-surgical units in a large university hospital implemented a blend of recorded and bedside nursing report. Outcomes monitored included patient and nursing satisfaction, patient falls, nursing overtime and medication errors. We found statistically significant improvements postimplementation in four patient survey items specifically impacted by the change to bedside report. Nursing perceptions of report were significantly improved in the areas of patient safety and involvement in care and nurse accountability postimplementation. However, there was a decline in nurse perception that report took a reasonable amount of time after bedside report implementation; contrary to these perceptions, there was no significant increase in nurse overtime. Patient falls at shift change decreased substantially after the implementation of bedside report. An intervening variable during the study period invalidated the comparison of medication errors pre- and postintervention. There was some indication from both patients and nurses that bedside report was not always consistently implemented. Several positive outcomes were documented in relation to the implementation of a blended bedside shift report, with few drawbacks. Nurse attitudes about report at the final data collection were more positive than at the initial postimplementation data collection. If properly implemented, nursing bedside report can result in improved patient and nursing satisfaction and patient safety outcomes. However, managers should involve staff nurses in the implementation process and continue to monitor consistency in report format as well as satisfaction with the process. © 2014 John Wiley & Sons Ltd.

Health-related quality of life of cancer patients with peripherally inserted central catheter: a pilot study.

PubMed

Kang, Junren; Chen, Wei; Sun, Wenyan; Ge, Ruibin; Li, Hailong; Ma, Enling; Su, Qingxia; Cheng, Fang; Hong, Jinhua; Zhang, Yuanjuan; Lei, Cheng; Wang, Xinchuan; Jin, Aiyun; Liu, Wanli

2017-09-11

This pilot exploratory study aimed to compare the health-related quality of life (HRQOL) among patients diagnosed with different types of cancer receiving peripherally inserted central catheters (PICCs). A multicenter cross-section study of cancer patients with PICCs was performed from February 1, 2013 to April 24, 2014. The primary objective of this study was to compare HRQOL in different cancer type patients with PICC. HRQOL was examined based on European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30). Multiple linear regression models were conducted for coping with potential confounding variables. We also examined PICC-related quality of daily life with a self-made questionnaire. Three hundred and fifty-seven cancer patients with PICC completed the survey in nine teaching hospitals. Lung cancer patients with PICC reported the worst dyspnea. Digestive tract cancer patients reported the worst appetite loss. Patients with hematologic malignancy reported the worst emotional, social function, fatigue and financial impact. Breast cancer patients reported better HRQOL. Baseline variables were proven not significant predictors of EORTC QLQ-C30 global health status. In self-made survey, pain after PICC insertion was null or a little in 98.6% of cancer patients. Limitation of upper extremity activity was null or a little in 94.1% of patients. HRQOL varies in different types of cancer patients with PICC. PICC may have a low impact on cancer patients' HRQOL. Further large sample studies are needed.

Expectations and limitations due to brachial plexus injury: a qualitative study.

PubMed

Mancuso, Carol A; Lee, Steve K; Dy, Christopher J; Landers, Zoe A; Model, Zina; Wolfe, Scott W

2015-12-01

This study described physical and psychosocial limitations associated with adult brachial plexus injuries (BPI) and patients' expectations of BPI surgery. During in-person interviews, preoperative patients were asked about expectations of surgery and preoperative and postoperative patients were asked about limitations due to BPI. Postoperative patients also rated improvement in condition after surgery. Data were analyzed with qualitative and quantitative techniques. Ten preoperative and 13 postoperative patients were interviewed; mean age was 37 years, 19 were men, all were employed/students, and most injuries were due to trauma. Preoperative patients cited several main expectations, including pain-related issues, and improvement in arm movement, self-care, family interactions, and global life function. Work-related expectations were tailored to employment type. Preoperative and postoperative patients reported that pain, altered sensation, difficulty managing self-care, becoming physically and financially dependent, and disability in work/school were major issues. All patients reported making major compensations, particularly using the uninjured arm. Most reported multiple mental health effects, were distressed with long recovery times, were self-conscious about appearance, and avoided public situations. Additional stresses were finding and paying for BPI surgery. Some reported BPI impacted overall physical health, life priorities, and decision-making processes. Four postoperative patients reported hardly any improvement, four reported some/a good deal, and five reported a great deal of improvement. BPI is a life-altering event affecting physical function, mental well-being, financial situation, relationships, self-image, and plans for the future. This study contributes to clinical practice by highlighting topics to address to provide comprehensive BPI patient-centered care.

Patient Experience Shows Little Relationship with Hospital Quality Management Strategies

PubMed Central

Groene, Oliver; Arah, Onyebuchi A.; Klazinga, Niek S.; Wagner, Cordula; Bartels, Paul D.; Kristensen, Solvejg; Saillour, Florence; Thompson, Andrew; Thompson, Caroline A.; Pfaff, Holger; DerSarkissian, Maral; Sunol, Rosa

2015-01-01

Objectives Patient-reported experience measures are increasingly being used to routinely monitor the quality of care. With the increasing attention on such measures, hospital managers seek ways to systematically improve patient experience across hospital departments, in particular where outcomes are used for public reporting or reimbursement. However, it is currently unclear whether hospitals with more mature quality management systems or stronger focus on patient involvement and patient-centered care strategies perform better on patient-reported experience. We assessed the effect of such strategies on a range of patient-reported experience measures. Materials and Methods We employed a cross-sectional, multi-level study design randomly recruiting hospitals from the Czech Republic, France, Germany, Poland, Portugal, Spain, and Turkey between May 2011 and January 2012. Each hospital contributed patient level data for four conditions/pathways: acute myocardial infarction, stroke, hip fracture and deliveries. The outcome variables in this study were a set of patient-reported experience measures including a generic 6-item measure of patient experience (NORPEQ), a 3-item measure of patient-perceived discharge preparation (Health Care Transition Measure) and two single item measures of perceived involvement in care and hospital recommendation. Predictor variables included three hospital management strategies: maturity of the hospital quality management system, patient involvement in quality management functions and patient-centered care strategies. We used directed acyclic graphs to detail and guide the modeling of the complex relationships between predictor variables and outcome variables, and fitted multivariable linear mixed models with random intercept by hospital, and adjusted for fixed effects at the country level, hospital level and patient level. Results Overall, 74 hospitals and 276 hospital departments contributed data on 6,536 patients to this study (acute myocardial infarction n = 1,379, hip fracture n = 1,503, deliveries n = 2,088, stroke n = 1,566). Patients admitted for hip fracture and stroke had the lowest scores across the four patient-reported experience measures throughout. Patients admitted after acute myocardial infarction reported highest scores on patient experience and hospital recommendation; women after delivery reported highest scores for patient involvement and health care transition. We found no substantial associations between hospital-wide quality management strategies, patient involvement in quality management, or patient-centered care strategies with any of the patient-reported experience measures. Conclusion This is the largest study so far to assess the complex relationship between quality management strategies and patient experience with care. Our findings suggest absence of and wide variations in the institutionalization of strategies to engage patients in quality management, or implement strategies to improve patient-centeredness of care. Seemingly counterintuitive inverse associations could be capturing a scenario where hospitals with poorer quality management were beginning to improve their patient experience. The former suggests that patient-centered care is not yet sufficiently integrated in quality management, while the latter warrants a nuanced assessment of the motivation and impact of involving patients in the design and assessment of services. PMID:26151864

Patient Experience Shows Little Relationship with Hospital Quality Management Strategies.

PubMed

Groene, Oliver; Arah, Onyebuchi A; Klazinga, Niek S; Wagner, Cordula; Bartels, Paul D; Kristensen, Solvejg; Saillour, Florence; Thompson, Andrew; Thompson, Caroline A; Pfaff, Holger; DerSarkissian, Maral; Sunol, Rosa

2015-01-01

Patient-reported experience measures are increasingly being used to routinely monitor the quality of care. With the increasing attention on such measures, hospital managers seek ways to systematically improve patient experience across hospital departments, in particular where outcomes are used for public reporting or reimbursement. However, it is currently unclear whether hospitals with more mature quality management systems or stronger focus on patient involvement and patient-centered care strategies perform better on patient-reported experience. We assessed the effect of such strategies on a range of patient-reported experience measures. We employed a cross-sectional, multi-level study design randomly recruiting hospitals from the Czech Republic, France, Germany, Poland, Portugal, Spain, and Turkey between May 2011 and January 2012. Each hospital contributed patient level data for four conditions/pathways: acute myocardial infarction, stroke, hip fracture and deliveries. The outcome variables in this study were a set of patient-reported experience measures including a generic 6-item measure of patient experience (NORPEQ), a 3-item measure of patient-perceived discharge preparation (Health Care Transition Measure) and two single item measures of perceived involvement in care and hospital recommendation. Predictor variables included three hospital management strategies: maturity of the hospital quality management system, patient involvement in quality management functions and patient-centered care strategies. We used directed acyclic graphs to detail and guide the modeling of the complex relationships between predictor variables and outcome variables, and fitted multivariable linear mixed models with random intercept by hospital, and adjusted for fixed effects at the country level, hospital level and patient level. Overall, 74 hospitals and 276 hospital departments contributed data on 6,536 patients to this study (acute myocardial infarction n = 1,379, hip fracture n = 1,503, deliveries n = 2,088, stroke n = 1,566). Patients admitted for hip fracture and stroke had the lowest scores across the four patient-reported experience measures throughout. Patients admitted after acute myocardial infarction reported highest scores on patient experience and hospital recommendation; women after delivery reported highest scores for patient involvement and health care transition. We found no substantial associations between hospital-wide quality management strategies, patient involvement in quality management, or patient-centered care strategies with any of the patient-reported experience measures. This is the largest study so far to assess the complex relationship between quality management strategies and patient experience with care. Our findings suggest absence of and wide variations in the institutionalization of strategies to engage patients in quality management, or implement strategies to improve patient-centeredness of care. Seemingly counterintuitive inverse associations could be capturing a scenario where hospitals with poorer quality management were beginning to improve their patient experience. The former suggests that patient-centered care is not yet sufficiently integrated in quality management, while the latter warrants a nuanced assessment of the motivation and impact of involving patients in the design and assessment of services.

Optimal recall period in assessing the adherence to antihypertensive therapy: a pilot study.

PubMed

Doró, Péter; Benko, Ria; Czakó, Anikó; Matuz, Mária; Thurzó, Ferenc; Soós, Gyöngyvér

2011-08-01

To evaluate the validity of patient self-reported adherence, and to find the optimal length of recall period which best reflects the long-term adherence pattern of the patient. Patients were recruited from a general practitioner's practice in a Hungarian town. In this prospective study 30 patients, who had already been on antihypertensive treatment, were involved. The study was designed to monitor one antihypertensive medication per patient for 3 months. Patients received a 3-month supply of one antihypertensive medication in an electronic Medication Event Monitoring System (MEMS). At the end of the study period patients completed a structured questionnaire regarding their medication taking behavior during the last 7, 14 and 30 days. The results measured with MEMS were considered as the reference value, and other measures were compared using the Bland-Altman method. Self-reported adherence, length of recall period, taking adherence and timing adherence measured by MEMS. Of the 30 patients included, 29 patients (13 males and 16 females) completed the study. The mean age of the patients was 60.6 years, ranging between 36 and 86 years. Patients were monitored for an average of 89 days (ranging between 49 and 106 days). Fifteen patients were on once daily, 9 patients were on twice daily, and 5 patients were on 3 times daily dosing schedule. The total expected number of medication taking events was 4,281. The MEMS caps recorded a total of 4,071 openings, which showed only a 3.56% deviation from the pill counts of the remaining tablets. The overall taking adherence was 95.1%, timing adherence was 75.2%. Patients' adherence report using a visual analog scale and reporting the number of missed doses became more accurate as the length of the recall period increased. Increased number of chronically taken medications was associated with better adherence. Increased dosing frequency of the observed antihypertensive medication resulted in decreased adherence. The results showed that the length of the recall period influences the accuracy of self-reported adherence. Patients seem to be able to report more precisely their medication taking behavior regarding a 30 day period than a 7 day period.

Assessing Patient-Centered Communication in Cancer Care: Stakeholder Perspectives

PubMed Central

Mazor, Kathleen M.; Gaglio, Bridget; Nekhlyudov, Larissa; Alexander, Gwen L.; Stark, Azadeh; Hornbrook, Mark C.; Walsh, Kathleen; Boggs, Jennifer; Lemay, Celeste A.; Firneno, Cassandra; Biggins, Colleen; Blosky, Mary Ann; Arora, Neeraj K.

2013-01-01

Purpose: Patient-centered communication is critical to quality cancer care. Effective communication can help patients and family members cope with cancer, make informed decisions, and effectively manage their care; suboptimal communication can contribute to care breakdowns and undermine clinician-patient relationships. The study purpose was to explore stakeholders' views on the feasibility and acceptability of collecting self-reported patient and family perceptions of communication experiences while receiving cancer care. The results were intended to inform the design, development, and implementation of a structured and generalizable patient-level reporting system. Methods: This was a formative, qualitative study that used semistructured interviews with cancer patients, family members, clinicians, and leaders of health care organizations. The constant comparative method was used to identify major themes in the interview transcripts. Results: A total of 106 stakeholders were interviewed. Thematic saturation was achieved. All stakeholders recognized the importance of communication and endorsed efforts to improve communication during cancer care. Patients, clinicians, and leaders expressed concerns about the potential consequences of reports of suboptimal communication experiences, such as damage to the clinician-patient relationship, and the need for effective improvement strategies. Patients and family members would report good communication experiences in order to encourage such practices. Practical and logistic issues were identified. Conclusion: Patient reports of their communication experiences during cancer care could increase understanding of the communication process, stimulate improvements, inform interventions, and provide a basis for evaluating changes in communication practices. This qualitative study provides a foundation for the design and pilot testing of such a patient reporting system. PMID:23943884

Patient-centered and visual quality outcomes of premium cataract surgery: a systematic review.

PubMed

Wang, Sophia Y; Stem, Maxwell S; Oren, Gale; Shtein, Roni; Lichter, Paul R

2017-06-26

Over 8 million cataract surgeries are performed in the United States and the European Union annually, with many patients choosing to pay out of pocket for premium options including premium intraocular lens implants (IOLs) or laser-assisted cataract surgery (LACS). This report provides a systematic review evaluating patient-centered and visual quality outcomes comparing standard monofocal IOLs to premium cataract surgery options. PubMed and EMBASE were searched for publications published between January 1, 1980, and September 18, 2016, on multifocal, accommodative, and toric IOLs, monovision, and LACS, which reported on 1) dysphotopsias, 2) contrast sensitivity, 3) spectacle independence, 4) vision-related quality of life or patient satisfaction, and 5) IOL exchange. Multifocal lenses achieved higher rates of spectacle independence compared to monofocal lenses but also had higher reported frequency of dysphotopsia and worse contrast sensitivity, especially with low light or glare. Accommodative lenses were not associated with reduced contrast sensitivity or more dysphotopsia but had only modest improvements in spectacle independence compared to monofocal lenses. Studies of monovision did not target a sufficiently myopic outcome in the near-vision eye to achieve the full potential for spectacle independence. Patients reported high levels of overall satisfaction regardless of implanted IOL. No studies correlated patient-reported outcomes with patient expectations. Studies are needed to thoroughly compare patient-reported outcomes with concomitant patient expectations. In light of the substantial patient costs for premium options, patients and their surgeons will benefit from a better understanding of which surgical options best meet patients' expectations and how those expectations can be impacted by premium versus monofocal-including monovision-options.

Patient Reporting of Safety experiences in Organisational Care Transfers (PRoSOCT): a feasibility study of a patient reporting tool as a proactive approach to identifying latent conditions within healthcare systems

PubMed Central

Scott, Jason; Waring, Justin; Heavey, Emily; Dawson, Pamela

2014-01-01

Background It is increasingly recognised that patients can play a role in reporting safety incidents. Studies have tended to focus on patients within hospital settings, and on the reporting of patient safety incidents as defined within a medical model of safety. This study aims to determine the feasibility of collecting and using patient experiences of safety as a proactive approach to identifying latent conditions of safety as patients undergo organisational care transfers. Methods and analysis The study comprises three components: (1) patients’ experiences of safety relating to a care transfer, (2) patients’ receptiveness to reporting experiences of safety, (3) quality improvement using patient experiences of safety. (1) A safety survey and evaluation form will be distributed to patients discharged from 15 wards across four clinical areas (cardiac, care of older people, orthopaedics and stroke) over 1 year. Healthcare professionals involved in the care transfer will be provided with a regular summary of patient feedback. (2) Patients (n=36) who return an evaluation form will be sampled representatively based on the four clinical areas and interviewed about their experiences of healthcare and safety and completing the survey. (3) Healthcare professionals (n=75) will be invited to participate in semistructured interviews and focus groups to discuss their experiences with and perceptions of receiving and using patient feedback. Data analysis will explore the relationship between patient experiences of safety and other indicators and measures of quality and safety. Interview and focus group data will be thematically analysed and triangulated with all other data sources using a convergence coding matrix. Ethics and dissemination The study has been granted National Health Service (NHS) Research Ethics Committee approval. Patient experiences of safety will be disseminated to healthcare teams for the purpose of organisational development and quality improvement. Results will be disseminated to study participants as well as through peer-reviewed outputs. PMID:24833698

Factors Associated with Congruence Between Preferred and Actual Place of Death

PubMed Central

Bell, Christina L.; Somogyi-Zalud, Emese; Masaki, Kamal H.

2009-01-01

Congruence between preferred and actual place of death may be an essential component in terminal care. Most patients prefer a home death, but many patients do not die in their preferred location. Specialized (physician, hospice and palliative) home care visits may increase home deaths, but factors associated with congruence have not been systematically reviewed. This study sought to review the extent of congruence reported in the literature, and examine factors that may influence congruence. In July 2009, a comprehensive literature search was performed using MEDLINE, Psych Info, CINAHL, and Web of Science. Reference lists, related articles, and the past five years of six palliative care journals were also searched. Overall congruence rates (percentage of met preferences for all locations of death) were calculated for each study using reported data to allow cross-study comparison. Eighteen articles described 30% to 91% congruence. Eight specialized home care studies reported 59% to 91% congruence. A physician-led home care program reported 91% congruence. Of the 10 studies without specialized home care for all patients, seven reported 56% to 71% congruence and most reported unique care programs. Of the remaining three studies without specialized home care for all patients, two reported 43% to 46% congruence among hospital inpatients, and one elicited patient preference “if everything were possible,” with 30% congruence. Physician support, hospice enrollment, and family support improved congruence in multiple studies. Research in this important area must consider potential sources of bias, the method of eliciting patient preference, and the absence of a single ideal place of death. PMID:20116205

Factors associated with congruence between preferred and actual place of death.

PubMed

Bell, Christina L; Somogyi-Zalud, Emese; Masaki, Kamal H

2010-03-01

Congruence between preferred and actual place of death may be an essential component in terminal care. Most patients prefer a home death, but many patients do not die in their preferred location. Specialized (physician, hospice, and palliative) home care visits may increase home deaths, but factors associated with congruence have not been systematically reviewed. This study sought to review the extent of congruence reported in the literature and examine factors that may influence congruence. In July 2009, a comprehensive literature search was performed using MEDLINE, PsychInfo, CINAHL, and Web of Science. Reference lists, related articles, and the past five years of six palliative care journals were also searched. Overall congruence rates (percentage of met preferences for all locations of death) were calculated for each study using reported data to allow cross-study comparison. Eighteen articles described 30%-91% congruence. Eight specialized home care studies reported 59%-91% congruence. A physician-led home care program reported 91% congruence. Of the 10 studies without specialized home care for all patients, seven reported 56%-71% congruence and most reported unique care programs. Of the remaining three studies without specialized home care for all patients, two reported 43%-46% congruence among hospital inpatients, and one elicited patient preference "if everything were possible," with 30% congruence. Physician support, hospice enrollment, and family support improved congruence in multiple studies. Research in this important area must consider potential sources of bias, the method of eliciting patient preference, and the absence of a single ideal place of death. (c) 2010 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

What impact does nursing care left undone have on patient outcomes? Review of the literature.

PubMed

Recio-Saucedo, Alejandra; Dall'Ora, Chiara; Maruotti, Antonello; Ball, Jane; Briggs, Jim; Meredith, Paul; Redfern, Oliver C; Kovacs, Caroline; Prytherch, David; Smith, Gary B; Griffiths, Peter

2018-06-01

Systematic review of the impact of missed nursing care on outcomes in adults, on acute hospital wards and in nursing homes. A considerable body of evidence supports the hypothesis that lower levels of registered nurses on duty increase the likelihood of patients dying on hospital wards, and the risk of many aspects of care being either delayed or left undone (missed). However, the direct consequence of missed care remains unclear. Systematic review. We searched Medline (via Ovid), CINAHL (EBSCOhost) and Scopus for studies examining the association of missed nursing care and at least one patient outcome. Studies regarding registered nurses, healthcare assistants/support workers/nurses' aides were retained. Only adult settings were included. Because of the nature of the review, qualitative studies, editorials, letters and commentaries were excluded. PRISMA guidelines were followed in reporting the review. Fourteen studies reported associations between missed care and patient outcomes. Some studies were secondary analyses of a large parent study. Most of the studies used nurse or patient reports to capture outcomes, with some using administrative data. Four studies found significantly decreased patient satisfaction associated with missed care. Seven studies reported associations with one or more patient outcomes including medication errors, urinary tract infections, patient falls, pressure ulcers, critical incidents, quality of care and patient readmissions. Three studies investigated whether there was a link between missed care and mortality and from these results no clear associations emerged. The review shows the modest evidence base of studies exploring missed care and patient outcomes generated mostly from nurse and patient self-reported data. To support the assertion that nurse staffing levels and skill mix are associated with adverse outcomes as a result of missed care, more research that uses objective staffing and outcome measures is required. Although nurses may exercise judgements in rationing care in the face of pressure, there are nonetheless adverse consequences for patients (ranging from poor experience of care to increased risk of infection, readmissions and complications due to critical incidents from undetected physiological deterioration). Hospitals should pay attention to nurses' reports of missed care and consider routine monitoring as a quality and safety indicator. © 2017 The Authors. Journal of Clinical Nursing Published by John Wiley & Sons Ltd.

Patient-reported outcomes and associations with pleural effusion in outpatients with heart failure: an observational cohort study

PubMed Central

Gundersen, Guri H; Norekvål, Tone M; Graven, Torbjørn; Haug, Hilde H; Skjetne, Kyrre; Kleinau, Jens O; Gustad, Lise T; Dalen, Håvard

2017-01-01

Objectives We aimed to study whether patient-reported outcomes, measured by quality of life (QoL) and functional class, are sensitive to pleural effusion (PLE) in patients with heart failure (HF), and to study changes in QoL and functional class during follow-up of PLE. Methods A cohort of 62 patients from an outpatient HF clinic was included. The amount of PLE was quantified using a pocket-sized ultrasound imaging device. Self-reports of QoL and functional class were collected using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the New York Heart Association (NYHA) functional classification. Results At baseline, 26 (42%) patients had PLE of which 19 (31%) patients had moderate to severe amounts of PLE. Patients with no to mild PLE had a lower MLHFQ score (mean 42, SD 21) compared with patients with a moderate to severe amount of PLE (mean 55, SD 24), p=0.03. For 28 patients (45%) with follow-up data, we observed a linear improvement of the MLHFQ-score (3.2, 95% CI 1.2 to 5.1) with each centimetre reduction of PLE. Correspondingly, patient-reported NYHA-class followed the same pattern as the MLHFQ-score. Conclusions Our study indicates that patient-reported outcome measures as MLHFQ may be sensitive tools to identify patients with HF at highest risk of symptomatic PLE and that treatment targeting reduction of PLE during follow-up is essential to improvement of QoL and functional capacity of outpatients with HF. Trial registration number NCT01794715; Results PMID:28320791

Existential struggle and self-reported needs of patients in rehabilitation.

PubMed

Sigurgeirsdottir, Jonina; Halldorsdottir, Sigridur

2008-02-01

This paper is a report of a study to increase understanding of patients' experience of rehabilitation and their self-reported needs in that context. Nurses need to be able to recognize patient needs to plan effective and individualized care. Needs-led nursing care is emphasized in the nursing literature, but few studies in rehabilitation have explored needs from the patient's perspective. The sample of this phenomenological study was purposively selected and the data consisted of 16 in-depth interviews with 12 people aged between 26 and 85 years. The data were collected in 2005. The findings showed that being a patient in rehabilitation involves existential struggling, as the reason behind patients' rehabilitation, accident or illness usually leads to trying to cope with existential changes while needing to adapt to new characteristics of life and self. This makes patients vulnerable and their self-reported needs include individualized caring and emotional support from family, peers and staff. Participants also reported a need for a sense of security in a stable and homelike environment, with assistance, help and presence. Finally, they reported needing goal-oriented and progressive care in which realistic and achievable goals were established. Individualized patient education enhanced their independence and empowered them towards a new and progressive lifestyle. A new emphasis is needed in rehabilitation nursing, involving assessment of existential well-being of patients by means of skilful interpersonal relationship based on individualized caring and emotional support and recognition of each patient's own hierarchy of needs.

Agreement between patients and general practitioners on quality deviations during the cancer diagnostic pathway and associations with time to diagnosis.

PubMed

Jensen, Henry; Sperling, Cecilie; Sandager, Mette; Vedsted, Peter

2015-06-01

High quality and minimal delay are crucial and anticipated elements in the diagnostic cancer pathway as delay in the diagnosis may worsen the prognosis and cause lower patient satisfaction. The aim of this study was to describe agreement in reported quality deviations (QDs) between general practitioners (GPs) and cancer patients during the diagnostic pathway in primary care and to estimate the association between length of diagnostic interval and level of agreement on reported QDs. The study was carried out as a Danish cross-sectional study of incident cancer patients identified in the Danish National Patient Registry. Data were collected by independent questionnaires from patients (response rate: 53.0%) and their GPs (response rate: 73.8%), and 2177 pairs of questionnaires were subsequently combined. Agreement between GP- and patient-reported QDs was estimated using Cohen's Kappa, whereas the association between level of agreement and time to diagnosis was estimated using quantile regression. Patients reported QDs in 29.0% and GPs in 28.5% of the cases, but agreed only slightly on QD presence (Kappas between -0.08 and 0.26). Agreement on 'QD presence' was associated with a 54-day (95%CI: 44-64) longer time to diagnosis than agreement on 'no QD presence'. The association with a longer diagnostic interval was stronger when only GP reported a QD the association than when only patient reported a QD. Included GPs and patients agreed only slightly on QD presence although they reported the same amount of QDs; this suggests that GPs and patients see QDs as two different concepts. QD presence had a stronger impact on time to diagnosis when reported by the GP (alone or in agreement with the patient) than when reported by the patient alone. The GP may thus be the most important source of information on QD and diagnostic interval, while the patient information tends to underpin this assessment. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Medication adherence in randomized controlled trials evaluating cardiovascular or mortality outcomes in dialysis patients: A systematic review.

PubMed

Murali, Karumathil M; Mullan, Judy; Chen, Jenny H C; Roodenrys, Steven; Lonergan, Maureen

2017-01-31

Medication non-adherence is common among renal dialysis patients. High degrees of non-adherence in randomized controlled trials (RCTs) can lead to failure to detect a true treatment effect. Cardio-protective pharmacological interventions have shown no consistent benefit in RCTs involving dialysis patients. Whether non-adherence contributes to this lack of efficacy is unknown. We aimed to investigate how medication adherence and drug discontinuation were assessed, reported and addressed in RCTs, evaluating cardiovascular or mortality outcomes in dialysis patients. Electronic database searches were performed in MEDLINE, EMBASE & Cochrane CENTRAL for RCTs published between 2005-2015, evaluating self-administered medications, in adult dialysis patients, which reported clinical cardiovascular or mortality endpoints, as primary or secondary outcomes. Study characteristics, outcomes, methods of measuring and reporting adherence, and data on study drug discontinuation were analyzed. Of the 642 RCTs in dialysis patients, 22 trials (12 placebo controlled), which included 19,322 patients, were eligible. The trialed pharmacological interventions included anti-hypertensives, phosphate binders, lipid-lowering therapy, cardio-vascular medications, homocysteine lowering therapy, fish oil and calcimimetics. Medication adherence was reported in five trials with a mean of 81% (range: 65-92%) in the intervention arm and 84.5% (range: 82-87%) in the control arm. All the trials that reported adherence yielded negative study outcomes for the intervention. Study-drug discontinuation was reported in 21 trials (mean 33.2%; 95% CI, 22.0 to 44.5, in intervention and 28.8%; 95% CI, 16.8 to 40.8, in control). Trials with more than 20% study drug discontinuation, more often yielded negative study outcomes (p = 0.018). Non-adherence was included as a contributor to drug discontinuation in some studies, but the causes of discontinuation were not reported consistently between studies, and non-adherence was listed under different categories, thereby potentiating the misclassification of adherence. Reporting of medication adherence and study-drug discontinuation in RCTs investigating cardiovascular or mortality endpoints in dialysis patients are inconsistent, making it difficult to compare studies and evaluate their impact on outcomes. Recommendations for consistent reporting of non-adherence and causes of drug discontinuation in RCTs will therefore help to assess their impact on clinical outcomes.

Caregiver reports of patient-initiated violence in psychosis.

PubMed

Onwumere, Juliana; Grice, Sarah; Garety, Philippa; Bebbington, Paul; Dunn, Graham; Freeman, Daniel; Fowler, David; Kuipers, Elizabeth

2014-07-01

Aggressive behaviour in psychosis is not uncommon. Community provision for people with psychosis has left informal caregivers to take on a greater role in their care. However, few studies have explored links between patient-initiated violence in mental health caregiving relationships and caregiver functioning. Our study investigated caregiver reports of aggressive acts committed by their relative with psychosis and their links to caregiver appraisals of the caregiving relationship and caregiver outcomes. Caregivers of patients with a recent relapse of psychosis, recruited to a psychological therapy trial, completed the audiotaped Camberwell Family Interview at baseline. This semi-structured interview includes questions on the quality of the relationship between caregiver and patient, and patient history of violence. Seventy-two transcripts of interviews were assessed for reports of patient-initiated violence. One-half of the caregiver sample (52.9%) reported an incident of patient-initiated violence during their interview; 62.2% of these involved violence toward themselves, and 24.3% toward property. Reports of patient violence were associated with caregiver ratings of hostility expressed toward patients, lower self-esteem, and emotion-focused coping. People caring on their own were more likely to report incidents of patient violence. Younger patients, males, and inpatients were more frequently identified as having a history of this kind of violence. Our findings suggested that caregiver reports of patient-initiated violence in psychosis are not uncommon. Mental health staff need to be aware of the risks of such violence for caregivers of people with psychosis, and consider appropriate procedures for minimizing it.

Cytokine Profile in Chronic Periodontitis Patients with and without Obesity: A Systematic Review and Meta-Analysis

PubMed Central

Abduljabbar, Tariq; Abu Hassan, Mohamed Ibrahim; Vohra, Fahim

2016-01-01

To investigate the cytokine profile as biomarkers in the gingival crevicular fluid (GCF) of chronic periodontitis (CP) patients with and without obesity, MEDLINE/PubMed, EMBASE, ScienceDirect, and SCOPUS databases were combined with handsearching of articles published from 1977 up to May 2016 using relevant MeSH terms. Meta-analyses were conducted separately for each of the cytokines: resistin, adiponectin, TNF-α, leptin, IL-6, IL-8, and IL-1β. Forest plots were produced reporting standardized mean difference of outcomes and 95% confidence intervals. Eleven studies were included. Three studies showed comparable levels of leptin among obese and nonobese patients with CP. Four studies reported comparable levels of interleukin- (IL-) 6 and resistin whereas five studies reported comparable levels of adiponectin. Two studies reported similar levels of CRP in patients with periodontitis with and without obesity. One study showed higher levels of tumor necrosis factor-alpha in obese patients with CP. One study showed higher levels of IL-1β and IL-8 in obese patients with CP. The level of localized periodontal inflammation may have a greater influence on the GCF proinflammatory biomarker levels as compared to systemic obesity. Whether patients having chronic periodontitis with obesity have elevated proinflammatory GCF biomarkers levels compared to nonobese individuals remains debatable. PMID:27795608

Revision of the Word Association Test for assessing associations of patients reporting satanic ritual abuse in childhood.

PubMed

Leavitt, F; Labott, S M

1998-11-01

A growing number of psychiatric patients report satanic ritual abuse, prompting research into this controversial area. In the current study, the Word Association Test (WAT) was modified to assess experience with satanic abuse. Pilot work resulted in norms for two domains: normative and satanic. Female psychiatric patients were compared on their associations in two studies. Based on a sexual history, they were grouped into those reporting sexual abuse, those reporting satanic ritual abuse (SRA), and those without a history of sexual abuse (controls). In both studies, SRA patients gave significantly more total associations, significantly fewer normative associations, and significantly more satanic associations than did the other two groups. These results suggest that an experience base is shared by individuals reporting SRA that is not found in individuals who do not report satanic abuse (even if they do report sexual abuse). The implications of these findings are discussed from the perspective of arguments advanced by advocates and critics of SRA.

The effectiveness of a self-reporting bedside pain assessment tool for oncology inpatients.

PubMed

Kim, Eun Bi; Han, Hye-Suk; Chung, Jung Hwa; Park, Bo Ram; Lim, Sung-Nam; Yim, Kyoung Hoon; Shin, Young Duck; Lee, Ki Hyeong; Kim, Wun-Jae; Kim, Seung Taik

2012-11-01

Pain is common during cancer treatment, and patient self-reporting of pain is an essential first step for ideal cancer pain management. However, many studies on cancer pain management report that, because pain may be underestimated, it is often inadequately managed. The aim of this study was to evaluate the effectiveness of bedside self-assessment of pain intensity for inpatients using a self-reporting pain board. Fifty consecutive inpatients admitted to the Oncology Department of Chungbuk National University Hospital were included in this observational prospective study from February 2011 to December 2011. The medical staff performed pain assessments by asking patients questions and using verbal rated scales (VRS) over 3 consecutive days. Then, for 3 additional days, patients used a self-reporting pain board attached to the bed, which had movable indicators representing 0-10 on a numeric rating scale (NRS) and the frequency of breakthrough pain. Patient reliability over the medical staff's pain assessment increased from 74% to 96% after applying the self-reporting pain board (p=0.004). The gap (mean±standard deviation [SD]) between the NRS reported by patients and the NRS recorded on the medical records decreased from 3.16±2.08 to 1.00±1.02 (p<0.001), and the level of patient satisfaction with pain management increased from 54% to 82% (p=0.002). This study suggests that the self-reporting bedside pain assessment tool provides a reliable and effective means of assessing pain in oncology inpatients.

Object relations and interpersonal problems in sexually abused female patients: an empirical study with the SCORS and the IIP.

PubMed

Kernhof, Karin; Kaufhold, Johannes; Grabhorn, Ralph

2008-01-01

In this study, we examined how retrospective reports of experiencing traumatic sexual abuse in childhood relates to both the development of self-representations and object representations and the occurrence of interpersonal problems. A total of 30 psychosomatic female patients who reported sexual abuse in childhood were compared with a corresponding number of eating-disordered patients and a nonclinical control group. The object relations technique (ORT; Phillipson, 1955), evaluated using the Social Cognition and Object Relations Scale (SCORS; Westen, 1985, 1991b), and the Inventory of Interpersonal Problems (Horowitz, Rosenberg, Baer, & Ureno, 1988) were used to measure the groups. The patients reporting sexual abuse achieved significantly lower scores in the cognitive scales of the SCORS; in the affective scales, they differed from the control group but not from the patients with an eating disorder. Concerning interpersonal problems, the patients reporting childhood sexual abuse reported interpersonal conflicts more frequently. The results of the study support the influence of traumatic sexual abuse on the formation of self-representations and object representations and on the occurrence of interpersonal conflicts.

Studies that report unexpected positive blood cultures for Lyme borrelia - are they valid?

PubMed

Wormser, Gary P; Shapiro, Eugene D; Strle, Franc

2017-11-01

Positive blood cultures for Lyme borrelia have been well documented in untreated patients with early Lyme disease. In this report we review the validity of three studies that reported the recovery of Borrelia burgdorferi sensu lato from the blood of a high proportion of patients for whom no evidence was presented, and no claim was made, that the patients had untreated early Lyme disease. In two of the studies the patients had been treated extensively with antibiotics for Lyme disease before the cultures were obtained. Critical evaluation of the three reports suggests that they are invalid. Indeed, two subsequently published studies could not reproduce the results of one of the reports. In a published analysis of another of the reports, investigators from the Centers for Disease Control and Prevention concluded that the cultures were likely to have been contaminated. When the biologic plausibility of recovering borrelia from blood is extremely low, the level of scientific rigor required of a study that claims a positive result should be particularly high. Copyright © 2017 Elsevier Inc. All rights reserved.

Self-reported alcohol abuse in HIV-HCV co-infected patients: a better predictor of HIV virological rebound than physician's perceptions (HEPAVIH ARNS CO13 cohort).

PubMed

Marcellin, Fabienne; Lions, Caroline; Winnock, Maria; Salmon, Dominique; Durant, Jacques; Spire, Bruno; Mora, Marion; Loko, Marc-Arthur; Dabis, François; Dominguez, Stéphanie; Roux, Perrine; Carrieri, Maria Patrizia

2013-07-01

Studying alcohol abuse impact, as measured by physicians' perceptions and patients' self-reports, on HIV virological rebound among patients chronically co-infected with HIV and hepatitis C virus (HCV). Cohort study. Seventeen French hospitals. Five hundred and twelve patients receiving antiretroviral therapy (ART) with an undetectable initial HIV viral load and at least two viral load measures during follow-up. Medical records and self-administered questionnaires. HIV virological rebound defined as HIV viral load above the limit of detection of the given hospital's laboratory test. Alcohol abuse defined as reporting to have drunk regularly at least 4 (for men) or 3 (for women) alcohol units per day during the previous 6 months. Correlates of time to HIV virological rebound identified using Cox proportional hazards models. At enrolment, 9% of patients reported alcohol abuse. Physicians considered 14.8% of all participants as alcohol abusers. Self-reported alcohol abuse was associated independently with HIV virological rebound [hazard ratio (95% confidence interval): 2.04 (1.13-3.67); P = 0.02], after adjustment for CD4 count, time since ART initiation and hospital HIV caseload. No significant relationship was observed between physician-reported alcohol abuse and virological rebound (P = 0.87). In France, the assessment of alcohol abuse in patients co-infected with HIV and hepatitis C virus should be based on patients' self-reports, rather than physicians' perceptions. Baseline screening of self-reported alcohol abuse may help identify co-infected patients at risk of subsequent HIV virological rebound. © 2013 Society for the Study of Addiction.

Standard of treatment and outcomes of adults with lupus nephritis in Africa: a systematic review.

PubMed

Ameh, O I; Kengne, A P; Jayne, D; Bello, A K; Hodkinson, B; Gcelu, A; Okpechi, I G

2016-10-01

Lupus nephritis (LN) is a significant cause of mortality and morbidity in patients with systemic lupus erythematosus (SLE) and the severity of disease has been described to be increased in Africans. Observational studies have been conducted; however, the treatment and outcome of African patients with LN has not been rigorously assessed. We conducted a systematic review of studies selected from a PubMed search of outcome in Africans with biopsy-proven LN from 1 January 1990 to 30 June 2015. Studies that gave information on histology, treatment and outcome of patients were included. Sixteen studies were selected from a search that yielded 302 papers; half were from North Africa, 2/16 (12.5%) were prospective studies and 2/16 (12.5%) were multi-centre studies. The sample size of reported biopsies in the studies ranged from 22 to 246 patients. Only 3/16 (18.8%) studies used more recent criteria for the classification and reporting of renal histology, and proliferative LN (class III and IV) were reported with increased frequency from the studies. For induction therapy, all the studies reported use of corticosteroids while 15/16 (93.8%) of the studies also used cyclophosphamide (CYC) as an induction agent. Overall mortality rates ranged from 7.9% to 34.9% with increased disease activity, kidney failure and infections cited as common causes of mortality. Five-year renal survival was 48-84% while five-year patient survival was 54%-94%. Survival rates were higher for studies reported from North Africa. This analysis highlights diagnostic challenges in LN in Africa and shows that a CYC/glucocorticoid-based regimen remains the standard of treatment for adult patients. The contributions of this therapy to reported outcomes of LN in Africa require further exploration. © The Author(s) 2016.

Patient Reported Outcomes in Preoperative and Postoperative Patients with Hypospadias.

PubMed

Keays, Melise A; Starke, Nathan; Lee, Simon C; Bernstein, Ira; Snodgrass, Warren T; Bush, Nicol C

2016-04-01

Current outcome tools for hypospadias have limited focus on the caregiver or patient perspective of important patient centered outcomes. In this study we collaborated with patients, caregivers, and lay and medical experts to develop and pilot a patient reported outcome measure for hypospadias. We developed a patient reported outcome measure based on systematic review of the literature and focus group input. The patient reported outcome measure was piloted in caregivers for boys younger than 8 years and in patients older than 8 years who presented for urology consultation before meeting with the surgeon. Patients were classified with uncorrected hypospadias, successful repair or failed repair based on the presence or absence of complications (fistula, diverticulum, meatal stenosis/stricture, greater than 30-degree recurrent curvature, glans dehiscence and/or skin reoperation). A patient reported outcome measure was developed and administered to 347 patients and/or caregivers-proxies, including 105 uncorrected cases, 162 successful repair cases and 80 failed cases. Satisfaction with appearance was highest in those with successful hypospadias repair compared to failed repair and uncorrected hypospadias (93% vs 77% and 67%, respectively). Voiding symptoms such as spraying or a deviated stream were highest in failed and uncorrected cases (39% and 37%, respectively). Overall dissatisfaction with voiding was highest for uncorrected hypospadias and failed repair compared to successful cases (54% and 47%, respectively, vs 15%). The evaluation of patient and caregiver-proxy reported outcomes in preoperative and postoperative patients with hypospadias allows for the quantification of benefits derived from hypospadias repair and may ultimately represent the gold standard outcome measure for hypospadias. This pilot study identified preliminary patient centered themes and demonstrated the feasibility of administering hypospadias patient reported outcome measures in clinical practice. Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Squamous cell carcinoma of the head and neck in never smoker-never drinkers: a descriptive epidemiologic study.

PubMed

Dahlstrom, Kristina R; Little, Jarrod A; Zafereo, Mark E; Lung, Margaret; Wei, Qingyi; Sturgis, Erich M

2008-01-01

While the attributed risk factors for the vast majority of patients with squamous cell carcinoma of the head and neck (SCCHN) are smoking and alcohol abuse, there appears to be a rising proportion of SCCHN patients who report no significant smoking or drinking history. This study reports the demographic and potential risk factors of a large series of never smoker-never drinker (NSND) patients. All subjects were participants in a prospective epidemiologic study of incident SCCHN. We obtained demographic data, clinical characteristics, and potential etiologic factors for 172 NSND patients and 1131 ever smoker-ever drinker (ESED) patients. RESULTS.: NSND patients were more likely to be female and to present at extremes of age, but overall were significantly younger than ESED patients. NSND patients had a higher proportion of oral cavity and oropharyngeal cancers than ESED patients had. Eleven percent of NSND patients (17% of NSND men) reported regular use of noncigarette tobacco products or marijuana, 41% (45% of NSND women) reported regular environmental exposure to tobacco smoke, 24% (36% of NSND men) reported regular occupational exposures to carcinogens/toxins, and 30% had a history of gastroesophageal reflux disease. More than half the NSND patients with an oropharyngeal primary were serologically positive for human papillomavirus type 16. NSND patients with SCCHN are commonly young women with oral tongue cancer, elderly women with gingival/buccal cancer, or young to middle-aged men with oropharyngeal cancer. While several exposures studied may be important to the etiology of a subset of these cancers in NSND patients, it is likely that no single known factor is responsible for a majority of SCCHN in NSNDs. Copyright (c) 2007 Wiley Periodicals, Inc.

Hand therapist use of patient report outcome (PRO) in practice: a survey study.

PubMed

Valdes, Kristin; MacDermid, Joy; Algar, Lori; Connors, Brian; Cyr, Lisa M; Dickmann, Sharon; Lucado, Ann M; Naughton, Nancy

2014-01-01

The purpose of this survey was to gain greater insight into hand therapists' use of Patient Report Outcome (PRO) measures. An 11-question survey that evaluated therapists' perceptions, preferences, and patterns of use of patient report outcome measures was sent to members of ASHT. A total of 633 ASHT members participated in the survey study. A large majority of participants (92%) responded affirmatively to using a PRO measure in practice. The DASH was reported as the most frequently used measure (90%). The majority of therapists (84%) discuss the results of the outcome measurement score with their patients. Of the participants who use more than one outcome measure, 44% report that this allows them to better establish their patient's functional and physical limitations. The findings in this study suggest that a large percentage of hand therapists are currently including a PRO measure in their hand therapy practice. Copyright © 2014 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

Analysis of contributing factors associated to related patients safety incidents in Intensive Care Medicine.

PubMed

Martín Delgado, M C; Merino de Cos, P; Sirgo Rodríguez, G; Álvarez Rodríguez, J; Gutiérrez Cía, I; Obón Azuara, B; Alonso Ovies, Á

2015-01-01

To explore contributing factors (CF) associated to related critical patients safety incidents. SYREC study pos hoc analysis. A total of 79 Intensive Care Departments were involved. The study sample consisted of 1.017 patients; 591 were affected by one or more incidents. The CF were categorized according to a proposed model by the National Patient Safety Agency from United Kingdom that was modified. Type, class and severity of the incidents was analyzed. A total 2,965 CF were reported (1,729 were associated to near miss and 1,236 to adverse events). The CF group more frequently reported were related patients factors. Individual factors were reported more frequently in near miss and task related CF in adverse events. CF were reported in all classes of incidents. The majority of CF were reported in the incidents classified such as less serious, even thought CF patients factors were associated to serious incidents. Individual factors were considered like avoidable and patients factors as unavoidable. The CF group more frequently reported were patient factors and was associated to more severe and unavoidable incidents. By contrast, individual factors were associated to less severe and avoidable incidents. In general, CF most frequently reported were associated to near miss. Copyright © 2014 Elsevier España, S.L.U. and SEMICYUC. All rights reserved.

Joint bleeds in von Willebrand disease patients have significant impact on quality of life and joint integrity: a cross-sectional study.

PubMed

van Galen, K P M; Sanders, Y V; Vojinovic, U; Eikenboom, J; Cnossen, M H; Schutgens, R E G; van der Bom, J G; Fijnvandraat, K; Laros-Van Gorkom, B A P; Meijer, K; Leebeek, F W G; Mauser-Bunschoten, E P

2015-05-01

Joint bleeds (JB) are reported in a minority of patients with von Willebrand disease (VWD) but may lead to structural joint damage. Prevalence, severity and impact of JB in VWD are largely unknown. The aim of this study was to assess JB prevalence, onset, treatment and impact on health-related quality of life (HR-QoL) and joint integrity in moderate and severe VWD. In the Willebrand in the Netherlands study 804 moderate and severe VWD patients [von Willebrand factor (VWF) activity ≤30U dL(-1)] completed a questionnaire on occurrence, sites and consequences of JB. To analyse JB number, onset, treatment and impact on joint integrity we additionally performed a patient-control study on medical file data comparing patients with JB to age, gender, factor VIII (FVIII)- and VWF activity matched VWD patients without JB. Of all VWD patients 23% (184/804) self-reported JB. These 184 patients reported joint damage more often (54% vs. 18%, P < 0.001) and had lower HR-QoL (SF36, P < 0.05) compared to VWD patients not reporting JB. Of 55 patients with available JB data, 65% had the first JB before age 16. These 55 patients used more clotting factor concentrate (CFC; median dose 43 vs. 0 IE FVIII kg(-1) year(-1) , P < 0.001), more often had X-ray joint damage (44% vs. 11%, P = 0.001] and chronic joint pain (44% vs. 18%, P = 0.008) compared to 55 control VWD patients without JB. In conclusion, joint bleeds are reported by 23% of moderate and severe VWD patients, mostly start in childhood, are associated with more CFC use, joint pain, lower HR-QoL and significantly more radiological and self-reported joint damage. © 2015 John Wiley & Sons Ltd.

Prediction of suicidal behavior in clinical research by lifetime suicidal ideation and behavior ascertained by the electronic Columbia-Suicide Severity Rating Scale.

PubMed

Mundt, James C; Greist, John H; Jefferson, James W; Federico, Michael; Mann, J John; Posner, Kelly

2013-09-01

To evaluate whether lifetime suicidal ideation with intention to act and/or suicidal behaviors reported at baseline predict risk of prospectively reporting suicidal behavior during subsequent study participation. Data from studies using the electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) to prospectively monitor suicidal ideation and behaviors between September 2009 and May 2011 were analyzed. Studies included patients with major depressive disorder, insomnia, posttraumatic stress disorder, epilepsy, and fibromyalgia. Records for 35,224 eC-SSRS assessments were extracted. Incomplete assessments and eC-SSRS records from patients missing a baseline assessment or with no prospective follow-up assessments were excluded. Baseline lifetime eC-SSRS reports were categorized as negative (no lifetime ideation with intent to act or prior suicidal behavior) or positive (lifetime ideation with intent to act but no prior behavior, no ideation with intent to act but prior behavior, or both lifetime ideation with intent and prior behavior). 3,776 patients completed a baseline and 1 or more follow-up assessments. The mean follow-up period was 64 days. Of patients with negative lifetime reports, 2.4% subsequently reported suicidal behavior during study participation, compared to 12.0% of patients with lifetime ideation with intent only (OR = 5.55; 95% CI, 2.65-11.59), 9.6% of patients with lifetime behavior only (OR = 4.33; 95% CI, 2.94-6.39), and 18.3% of patients with both (OR = 9.13; 95% CI, 6.47-12.88). Sensitivity and specificity of positive reports for identifying suicidal behaviors were 0.67 and 0.76, respectively. Patients reporting lifetime suicidal ideation with intent to act and/or prior suicidal behavior at baseline are 4 to 9 times more likely to prospectively report suicidal behavior during study participation. © Copyright 2013 Physicians Postgraduate Press, Inc.

Preferred Roles in Treatment Decision Making Among Patients With Cancer: A Pooled Analysis of Studies Using the Control Preferences Scale

PubMed Central

Singh, Jasvinder A.; Sloan, Jeff A.; Atherton, Pamela J.; Smith, Tenbroeck; Hack, Thomas F.; Huschka, Mashele M.; Rummans, Teresa A.; Clark, Matthew M.; Diekmann, Brent; Degner, Lesley F.

2010-01-01

Objectives To collect normative data, assess differences between demographic groups, and indirectly compare US and Canadian medical systems relative to patient expectations of involvement in cancer treatment decision making. Study Design Meta-analysis. Methods Individual patient data were compiled across 6 clinical studies among 3491 patients with cancer who completed the 2-item Control Preferences Scale indicating the roles they preferred versus actually experienced in treatment decision making. Results The roles in treatment decision making that patients preferred were 26% active, 49% collaborative, and 25% passive. The roles that patients reported actually experiencing were 30% active, 34% collaborative, and 36% passive. Roughly 61% of patients reported having their preferred role; only 6% experienced extreme discordance between their preferred versus actual roles. More men than women (66% vs 60%, P = .001) and more US patients than Canadian patients (84% vs 54%, P <.001) reported concordance between their preferred versus actual roles. More Canadian patients than US patients preferred and actually experienced (42% vs 18%, P <.001) passive roles. More women than men reported taking a passive role (40% vs 24%, P <.001). Older patients preferred and were more likely than younger patients to assume a passive role. Conclusions Roughly half of the studied patients with cancer indicated that they preferred to have a collaborative relationship with physicians. Although most patients had the decision-making role they preferred, about 40% experienced discordance. This highlights the need for incorporation of individualized patient communication styles into treatment plans. PMID:20873956

Screening for distress, the 6th vital sign: common problems in cancer outpatients over one year in usual care: associations with marital status, sex, and age

PubMed Central

2012-01-01

Background Very few studies examine the longitudinal prevalence of problems and the awareness or use of clinical programs by patients who report these problems. Of the studies that examine age, gender and marital status as predictors of a range of patient outcomes, none examines the interactions between these demographic variables. This study examined the typical trajectory of common practical and psychosocial problems endorsed over 12 months in a usual-care sample of cancer outpatients. Specifically, we examined whether marital status, sex, age, and their interactions predicted these trajectories. We did not actively triage or refer patients in this study in order to examine the natural course of problem reports. Methods Patients completed baseline screening (N = 1196 of 1707 approached) and the sample included more men (N = 696) than women (N = 498), average age 61.1 years. The most common diagnoses were gastrointestinal (27.1%), prostate (19.2%), skin (11.1%) and gynecological (9.2%). Among other measures, patients completed a Common Problem Checklist and Psychosocial Resources Use questions at baseline, 3, 6, and 12 months using paper and pencil surveys. Results Results indicated that patients reported psychosocial problems more often than practical and both decreased significantly over time. Younger single patients reported more practical problems than those in committed relationships. Younger patients and women of all ages reported more psychosocial problems. Among a number of interesting interactions, for practical problems, single older patients improved more; whereas among married people, younger patients improved more. For psychosocial problems we found that older female patients improved more than younger females, but among males, it was younger patients who improved more. Young single men and women reported the most past-and future-use of services. Conclusions Younger women are particularly vulnerable to experiencing practical and psychosocial problems when diagnosed with cancer, but being married protects these younger women. Marriage appeared to buffer reports of both practical and psychosocial problems, and led to less awareness and use of services. Unexpectedly, young men reported the highest use of psychosocial services. This study informs clinical program development with information on these risk groups. PMID:23031647

Distance and near visual acuity improvement after implantation of multifocal intraocular lenses in cataract patients with presbyopia: a systematic review.

PubMed

Agresta, Blaise; Knorz, Michael C; Kohnen, Thomas; Donatti, Christina; Jackson, Daniel

2012-06-01

To evaluate uncorrected distance visual acuity (UDVA) as well as uncorrected near visual acuity (UNVA) as outcomes in treating presbyopic cataract patients to assist clinicians and ophthalmologists in their decision-making process regarding available interventions. Medline, Embase, and Evidence Based Medicine Reviews were systematically reviewed to identify studies reporting changes in UDVA and UNVA after cataract surgery in presbyopic patients. Strict inclusion/exclusion criteria were used to exclude any studies not reporting uncorrected visual acuity in a presbyopic population with cataracts implanted with multifocal intraocular lenses (IOLs). Relevant outcomes (UDVA and UNVA) were identified from the studies retrieved through the systematic review process. Twenty-nine studies were identified that reported uncorrected visual acuities, including one study that reported uncorrected intermediate visual acuity. Nine brands of multifocal IOLs were identified in the search. All studies identified in the literature search reported improvements in UDVA and UNVA following multifocal IOL implantation. The largest improvements in visual acuity were reported using the Rayner M-Flex lens (Rayner Intraocular Lenses Ltd) (UDVA, binocular: 1.05 logMAR, monocular: 0.92 logMAR; UNVA, binocular and monocular: 0.83 logMAR) and the smallest improvements were reported using the Acri.LISA lens (Carl Zeiss Meditec) (UDVA, 0.21 decimal; UNVA, 0.51 decimal). The results of this systematic review show the aggregate of studies reporting a beneficial increase in UDVA and UNVA with the use of multifocal IOLs in cataract patients with presbyopia, hence providing evidence to support the hypothesis that multifocal IOLs increase UDVA and UNVA in cataract patients. Copyright 2012, SLACK Incorporated.

A Multilevel Analysis of U.S. Hospital Patient Safety Culture Relationships With Perceptions of Voluntary Event Reporting.

PubMed

Burlison, Jonathan D; Quillivan, Rebecca R; Kath, Lisa M; Zhou, Yinmei; Courtney, Sam C; Cheng, Cheng; Hoffman, James M

2016-11-03

Patient safety events offer opportunities to improve patient care, but, unfortunately, events often go unreported. Although some barriers to event reporting can be reduced with electronic reporting systems, insight on organizational and cultural factors that influence reporting frequency may help hospitals increase reporting rates and improve patient safety. The purpose of this study was to evaluate the associations between dimensions of patient safety culture and perceived reporting practices of safety events of varying severity. We conducted a cross-sectional survey study using previously collected data from The Agency for Healthcare Research and Quality Hospital Survey of Patient Safety Culture as predictors and outcome variables. The dataset included health-care professionals in U.S. hospitals, and data were analyzed using multilevel modeling techniques. Data from 223,412 individuals, 7816 work areas/units, and 967 hospitals were analyzed. Whether examining near miss, no harm, or potential for harm safety events, the dimension feedback about error accounted for the most unique predictive variance in the outcome frequency of events reported. Other significantly associated variables included organizational learning, nonpunitive response to error, and teamwork within units (all P < 0.001). As the perceived severity of the safety event increased, more culture dimensions became significantly associated with voluntary reporting. To increase the likelihood that a patient safety event will be voluntarily reported, our study suggests placing priority on improving event feedback mechanisms and communication of event-related improvements. Focusing efforts on these aspects may be more efficient than other forms of culture change.

A Multilevel Analysis of U.S. Hospital Patient Safety Culture Relationships with Perceptions of Voluntary Event Reporting

PubMed Central

Burlison, Jonathan D.; Quillivan, Rebecca R.; Kath, Lisa M.; Zhou, Yinmei; Courtney, Sam C.; Cheng, Cheng; Hoffman, James M.

2016-01-01

Objectives Patient safety events offer opportunities to improve patient care, but, unfortunately, events often go unreported. Although some barriers to event reporting can be reduced with electronic reporting systems, insight on organizational and cultural factors that influence reporting frequency may help hospitals increase reporting rates and improve patient safety. The purpose of this study was to evaluate the associations between dimensions of patient safety culture and perceived reporting practices of safety events of varying severity. Methods We conducted a cross-sectional survey study using previously collected data from The Agency for Healthcare Research and Quality Hospital Survey of Patient Safety Culture as predictors and outcome variables. The dataset included healthcare professionals in U.S. hospitals, and data were analyzed by using multilevel modeling techniques. Results Data from 223,412 individuals, 7816 work areas/units and 967 hospitals were analyzed. Whether examining Near-miss, No harm, or Potential for harm safety events, the dimension Feedback about error accounted for the most unique predictive variance in the outcome Frequency of events reported. Other significantly associated variables included Organizational learning, Nonpunitive response to error, and Teamwork within units (all p<.001). As the perceived severity of the safety event increased, more culture dimensions became significantly associated with voluntary reporting. Conclusions To increase the likelihood that a patient safety event will be voluntarily reported, our study suggests placing priority on improving event feedback mechanisms and communication of event-related improvements. Focusing efforts on these aspects may be more efficient than other forms of culture change. PMID:27820722

How Patients Take Malaria Treatment: A Systematic Review of the Literature on Adherence to Antimalarial Drugs

PubMed Central

Bruxvoort, Katia; Goodman, Catherine; Kachur, S. Patrick; Schellenberg, David

2014-01-01

Background High levels of patient adherence to antimalarial treatment are important in ensuring drug effectiveness. To achieve this goal, it is important to understand levels of patient adherence, and the range of study designs and methodological challenges involved in measuring adherence and interpreting results. Since antimalarial adherence was reviewed in 2004, there has been a major expansion in the use of artemisinin-based combination therapies (ACTs) in the public sector, as well as initiatives to make them more widely accessible through community health workers and private retailers. These changes and the large number of recent adherence studies raise the need for an updated review on this topic. Objective We conducted a systematic review of studies reporting quantitative results on patient adherence to antimalarials obtained for treatment. Results The 55 studies identified reported extensive variation in patient adherence to antimalarials, with many studies reporting very high adherence (90–100%) and others finding adherence of less than 50%. We identified five overarching approaches to assessing adherence based on the definition of adherence and the methods used to measure it. Overall, there was no clear pattern in adherence results by approach. However, adherence tended to be higher among studies where informed consent was collected at the time of obtaining the drug, where patient consultations were directly observed by research staff, and where a diagnostic test was obtained. Conclusion Variations in reported adherence may reflect factors related to patient characteristics and the nature of their consultation with the provider, as well as methodological variations such as interaction between the research team and patients before and during the treatment. Future studies can benefit from an awareness of the impact of study procedures on adherence outcomes, and the identification of improved measurement methods less dependent on self-report. PMID:24465418

How patients take malaria treatment: a systematic review of the literature on adherence to antimalarial drugs.

PubMed

Bruxvoort, Katia; Goodman, Catherine; Kachur, S Patrick; Schellenberg, David

2014-01-01

High levels of patient adherence to antimalarial treatment are important in ensuring drug effectiveness. To achieve this goal, it is important to understand levels of patient adherence, and the range of study designs and methodological challenges involved in measuring adherence and interpreting results. Since antimalarial adherence was reviewed in 2004, there has been a major expansion in the use of artemisinin-based combination therapies (ACTs) in the public sector, as well as initiatives to make them more widely accessible through community health workers and private retailers. These changes and the large number of recent adherence studies raise the need for an updated review on this topic. We conducted a systematic review of studies reporting quantitative results on patient adherence to antimalarials obtained for treatment. The 55 studies identified reported extensive variation in patient adherence to antimalarials, with many studies reporting very high adherence (90-100%) and others finding adherence of less than 50%. We identified five overarching approaches to assessing adherence based on the definition of adherence and the methods used to measure it. Overall, there was no clear pattern in adherence results by approach. However, adherence tended to be higher among studies where informed consent was collected at the time of obtaining the drug, where patient consultations were directly observed by research staff, and where a diagnostic test was obtained. Variations in reported adherence may reflect factors related to patient characteristics and the nature of their consultation with the provider, as well as methodological variations such as interaction between the research team and patients before and during the treatment. Future studies can benefit from an awareness of the impact of study procedures on adherence outcomes, and the identification of improved measurement methods less dependent on self-report.

Patients reported outcome post-cochlear implantation: how severe is their dizziness?

PubMed

Zawawi, Faisal; Alobaid, Faisal; Leroux, Tony; Zeitouni, Anthony G

2014-01-01

The reported prevalence of vestibular dysfunction after cochlear implantation (CI) is varies between different scientific papers. The aim of this study is to determine the reported post-implantation outcome in terms of dizziness, and to measure its impact on quality of life using the Dizziness handicap inventory (DHI). This was a prospective questionnaire based study of postoperative cochlear implant patients. The questionnaire assessed the type and onset of dizziness in addition to the DHI. 122 patients were recruited in this study, which is the largest sample size in the literature reported so far. Dizziness was evident in 45.9% of the population post-CI and in 27% pre-CI. The commonest subtype of the dizziness was unsteadiness followed by lightheadedness. The dizziness was mild in most of the patients. Although mild, dizziness is a common complaint post-cochlear implantation. An understanding of symptoms helps counsel patients preoperatively.

Nurses' shift reports: a systematic literature search and critical review of qualitative field studies.

PubMed

Buus, Niels; Hoeck, Bente; Hamilton, Bridget Elizabeth

2017-10-01

To identify reporting practices that feature in studies of nurses' shift reports across diverse nursing specialities. The objectives were to perform an exhaustive systematic literature search and to critically review the quality and findings of qualitative field studies of nurses' shift reports. Nurses' shift reports are routine occurrences in healthcare organisations that are viewed as crucial for patient outcomes, patient safety and continuity of care. Studies of communication between nurses attend primarily to 1:1 communication and analyse the adequacy and accuracy of patient information and feature handovers at the bedside. Still, verbal reports between groups of nurses about patients are commonplace. Shift reports are obvious sites for studying the situated accomplishment of professional nursing at the group level. This review is focused exclusively on qualitative field research for nuanced and contextualised insights into nurses' everyday shift reporting practices. The study is a systematic literature search and critical review of qualitative field analyses of nurses' shift reports. We searched in the databases CIHAHL, PubMed and PsycINFO and identified and reviewed 19 articles published 1992-2014. Data were systematically extracted using criteria for the evaluation of qualitative research reports. The studies described shift report practices and identified several factors contributing to distribution of clinical knowledge. Shift report practices were described as highly conventionalised and locally situated, but with occasional opportunities for improvisation and negotiation between nurses. Finally, shift reports were described as multifunctional meetings, with individual and social effects for nurses and teams. Innovations in between-shift communications can benefit from this analysis, by providing for the many functions of handovers that are revealed in field studies. Leaders and practising nurses may consider what are the best opportunities for nurses to work up clinical knowledge and negotiate care. © 2016 John Wiley & Sons Ltd.

Caregiver Preference and Treatment Compliance in Patients with Mild-to-Moderate Alzheimer's Disease in South Korea: RECAP Study Results.

PubMed

Lee, Kang Joon; Cho, Seong-Jin; Kim, Byeong Chae; Park, Minseok; Lee, Jae-Hong

2017-02-01

The aim of this study was to assess caregiver preference and treatment compliance with oral and transdermal medications in a "real-world" setting in patients with mild-to-moderate Alzheimer's disease (AD) in South Korea. Real-world evaluation of compliance and preference in Alzheimer's disease treatment (RECAP) was a 24-week, multicenter, prospective, non-interventional study in patients with AD treated with oral or transdermal therapy. Here, we report data from patients living in South Korea. Eligible patients were grouped into one of two treatment cohorts: oral (donepezil, galantamine, rivastigmine, or memantine) or transdermal (rivastigmine patch). Caregiver preference, patient compliance, and physician preference were assessed at week 24 (end of the study). Safety was assessed by reported adverse events (AEs). A total of 398 patients were enrolled (oral 51.8%; transdermal 48.2%) and 79.4% completed the study. Caregivers of patients that were exposed to either the oral or transdermal monotherapy showed a preference for the treatment to which the patients were exposed (both p < 0.0001). However, caregivers of patients that were exposed to both forms of treatments reported a higher preference for transdermal monotherapy (65.9%; p < 0.0041). Patients in both treatment cohorts showed good compliance, with an overall mean (SD) score of 8.84 (1.514) (a median of 9). Of the 15 participating physicians, eight indicated their preference for transdermal therapy and seven preferred oral therapy at week 24. A total of 133 (33.4%) patients reported at least one AE during the study period (oral: 60 patients; transdermal: 73 patients). The study showed higher caregiver preference for transdermal monotherapy over oral monotherapy when patients with AD were exposed to both forms of treatment and good patient compliance for both oral and transdermal treatments.

A systematic review of reliable and valid tools for the measurement of patient participation in healthcare.

PubMed

Phillips, Nicole Margaret; Street, Maryann; Haesler, Emily

2016-02-01

Patient participation in healthcare is recognised internationally as essential for consumer-centric, high-quality healthcare delivery. Its measurement as part of continuous quality improvement requires development of agreed standards and measurable indicators. This systematic review sought to identify strategies to measure patient participation in healthcare and to report their reliability and validity. In the context of this review, patient participation was constructed as shared decision-making, acknowledging the patient as having critical knowledge regarding their own health and care needs and promoting self-care/autonomy. Following a comprehensive search, studies reporting reliability or validity of an instrument used in a healthcare setting to measure patient participation, published in English between January 2004 and March 2014 were eligible for inclusion. From an initial search, which identified 1582 studies, 156 studies were retrieved and screened against inclusion criteria. Thirty-three studies reporting 24 patient participation measurement tools met inclusion criteria, and were critically appraised. The majority of studies were descriptive psychometric studies using prospective, cross-sectional designs. Almost all the tools completed by patients, family caregivers, observers or more than one stakeholder focused on aspects of patient-professional communication. Few tools designed for completion by patients or family caregivers provided valid and reliable measures of patient participation. There was low correlation between many of the tools and other measures of patient satisfaction. Few reliable and valid tools for measurement of patient participation in healthcare have been recently developed. Of those reported in this review, the dyadic Observing Patient Involvement in Decision Making (dyadic-OPTION) tool presents the most promise for measuring core components of patient participation. There remains a need for further study into valid, reliable and feasible strategies for measuring patient participation as part of continuous quality improvement. 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/

Improving the Capture of Fall Events in Hospitals: Combining a Service for Evaluating Inpatient Falls with an Incident Report System

PubMed Central

Shorr, Ronald I.; Mion, Lorraine C.; Chandler, A. Michelle; Rosenblatt, Linda C.; Lynch, Debra; Kessler, Lori A.

2008-01-01

OBJECTIVES To determine the utility of a fall evaluation service to improve the ascertainment of falls in acute care. DESIGN Six-month observational study. SETTING Sixteen adult nursing units (349 beds) in an urban, academically affiliated, community hospital. PARTICIPANTS Patients admitted to the study units during the study period. INTERVENTION Nursing staff identifying falls were instructed to notify, using a pager, a trained nurse ‘‘fall evaluator.’’ Fall evaluators provided 24-hour-per-day 7-day-per-week coverage throughout the study. Data on patient falls gathered by fall evaluators were compared with falls data obtained through the hospital’s incident reporting system. RESULTS During 51,180 patient-days of observation, 191 falls were identified according to incident reports (3.73 falls/1,000 patient-days), whereas the evaluation service identified 228 falls (4.45 falls/1,000 patient-days). Combining falls reported from both data sources yielded 266 falls (5.20 falls/1,000 patient-days), a 39% relative rate increase compared with incident reports alone (P<.001). For falls with injury, combining data from both sources yielded 79 falls (1.54 injurious falls/1,000 patient-days), compared with 57 falls (1.11 injurious falls/1,000 patient-days) filed in incident reports—a 28% increase (P = .06). In the 16 nursing units, the relative percentage increase of captured fall events using the combined data sources versus the incident reporting system alone ranged from 13% to 125%. CONCLUSION Incident reports significantly underestimate both injurious and noninjurious falls in acute care settings and should not be used as the sole source of data for research or quality improvement initiatives. PMID:18205761

Discrepancies between patients' and partners' perceptions of unsupportive behavior in chronic obstructive pulmonary disease.

PubMed

Snippe, Evelien; Maters, Gemma A; Wempe, Johan B; Hagedoorn, Mariët; Sanderman, Robbert

2012-06-01

The literature on chronic diseases indicates that partner support, as perceived by patients, contributes to well-being of patients in either a positive or a negative way. Previous studies indicated that patients' and partners' perceptions of unsupportive partner behavior are only moderately related. Our aim was (1) to investigate whether discrepancies between patients' and partners' perceptions of two types of unsupportive partner behavior-overprotection and protective buffering-were associated with the level of distress reported by patients with chronic obstructive pulmonary disease (COPD) and (2) to evaluate whether the direction of the differences between patients' and partners' perceptions was associated with distress (i.e., whether patient distress was associated with greater patient or greater partner reports of unsupportive partner behavior). A cross-sectional study was performed using the data of a sample of 68 COPD patients and their spouses. Distress was assessed using the Hopkins Symptom Checklist-25. Patients' and partners' perceptions of unsupportive partner behavior were assessed with a questionnaire measuring overprotection and protective buffering. Distress was independently associated with patients' perceptions of protective buffering and discrepancies in spouses' perceptions of overprotection. Regarding the direction of the discrepancy, we found that greater partner reports of overprotection as compared with patient reports were related to more distress in COPD patients. Our study showed that patients' distress was associated not only with patients' perceptions, but also with discrepancies between patients' and partners' perceptions of unsupportive partner behavior. PsycINFO Database Record (c) 2012 APA, all rights reserved.

What is the current evidence of the impact on quality of life whilst waiting for management/treatment of orthopaedic/musculoskeletal complaints? A systematic scoping review.

PubMed

Morris, Joanne; Twizeyemariya, Asterie; Grimmer, Karen

2018-04-02

To describe quality of life (QoL) outcome measures that are reported in the literature in patients waiting for outpatient orthopaedic/musculoskeletal specialist care and how waiting impacts on QoL in these terms. A subset of studies reporting on QoL outcome measures were extracted from literature identified in a recent scoping search of Medline, Embase, Pubmed, NHS Economic Evaluation Database (Prospero registration CRD42016047332). The systematic scoping search examined impacts on patients waiting for orthopaedic specialist care. Two independent reviewers ranked study design using the National Health and Medical Research Council aetiology evidence hierarchy, and appraised study quality using Critical Appraisal Skills Programme tools. QoL measures were mapped against waiting period timepoints. The scoping search yielded 142 articles, of which 18 reported on impact on QoL. These studies reported only on patients waiting for hip and/or knee replacement surgery. The most recent study reported on data collected in 2006/7. The Western Ontario and McMaster Universities Arthritis Index and the SF-36 were the most commonly reported QoL measures. QoL was measured at variable timepoints in the waiting period (from a few weeks to greater than 12 months). The impact of waiting on QoL was inconsistent. The evidence base was over 10 years old, reported only on patients with hip and knee problems, and on limited QoL outcome measures, and with inconsistent findings. A better understanding of the impact on QoL for patients waiting for specialist care could be gained by using standard timepoints in the waiting period, patients with other orthopaedic conditions, comprehensive QoL measures, as well as expectations, choices and perspectives of patients waiting for specialist care.

Patient-reported outcomes and associations with pleural effusion in outpatients with heart failure: an observational cohort study.

PubMed

Gundersen, Guri H; Norekvål, Tone M; Graven, Torbjørn; Haug, Hilde H; Skjetne, Kyrre; Kleinau, Jens O; Gustad, Lise T; Dalen, Håvard

2017-03-20

We aimed to study whether patient-reported outcomes, measured by quality of life (QoL) and functional class, are sensitive to pleural effusion (PLE) in patients with heart failure (HF), and to study changes in QoL and functional class during follow-up of PLE. A cohort of 62 patients from an outpatient HF clinic was included. The amount of PLE was quantified using a pocket-sized ultrasound imaging device. Self-reports of QoL and functional class were collected using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the New York Heart Association (NYHA) functional classification. At baseline, 26 (42%) patients had PLE of which 19 (31%) patients had moderate to severe amounts of PLE. Patients with no to mild PLE had a lower MLHFQ score (mean 42, SD 21) compared with patients with a moderate to severe amount of PLE (mean 55, SD 24), p=0.03. For 28 patients (45%) with follow-up data, we observed a linear improvement of the MLHFQ-score (3.2, 95% CI 1.2 to 5.1) with each centimetre reduction of PLE. Correspondingly, patient-reported NYHA-class followed the same pattern as the MLHFQ-score. Our study indicates that patient-reported outcome measures as MLHFQ may be sensitive tools to identify patients with HF at highest risk of symptomatic PLE and that treatment targeting reduction of PLE during follow-up is essential to improvement of QoL and functional capacity of outpatients with HF. NCT01794715; Results. 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/.

Increased odds of patient-reported success at 2 years after anterior cruciate ligament reconstruction in patients without cartilage lesions: a cohort study from the Swedish National Knee Ligament Register.

PubMed

Hamrin Senorski, Eric; Alentorn-Geli, Eduard; Musahl, Volker; Fu, Freddie; Krupic, Ferid; Desai, Neel; Westin, Olof; Samuelsson, Kristian

2018-04-01

To investigate whether the surgical technique of single-bundle anterior cruciate ligament (ACL) reconstruction, the visualization of anatomic surgical factors and the presence or absence of concomitant injuries at primary ACL reconstruction are able to predict patient-reported success and failure. The hypothesis of this study was that anatomic single-bundle surgical procedures would be predictive of patient-reported success. This cohort study was based on data from the Swedish National Knee Ligament Register during the period of 1 January 2005 through 31 December 2014. Patients who underwent primary single-bundle ACL reconstruction with hamstring tendons were included. Details on surgical technique were collected using an online questionnaire comprising essential anatomic anterior cruciate ligament reconstruction scoring checklist items, defined as the utilization of accessory medial portal drilling, anatomic tunnel placement, the visualization of insertion sites and pertinent landmarks. A univariate logistic regression model adjusted for age and gender was used to determine predictors of patient-reported success and failure, i.e. 20th and 80th percentile, respectively, in the Knee injury and Osteoarthritis Outcome Score (KOOS), 2 years after ACL reconstruction. In the 6889 included patients, the surgical technique used for single-bundle ACL reconstruction did not predict the predefined patient-reported success or patient-reported failure in the KOOS 4 . Patient-reported success was predicted by the absence of concomitant injury to the meniscus (OR = 0.81 [95% CI, 0.72-0.92], p = 0.001) and articular cartilage (OR = 0.70 [95% CI, 0.61-0.81], p < 0.001). Patient-reported failure was predicted by the presence of a concomitant injury to the articular cartilage (OR = 1.27 [95% CI, 1.11-1.44], p < 0.001). Surgical techniques used in primary single-bundle ACL reconstruction did not predict the KOOS 2 years after the reconstruction. However, the absence of concomitant injuries at index surgery predicted patient-reported success in the KOOS. The results provide further evidence that concomitant injuries at ACL reconstruction affect subjective knee function and a detailed knowledge of the treatment of these concomitant injuries is needed. Retrospective cohort study, Level III.

The Relationships Among Perceived Patients' Safety Culture, Intention to Report Errors, and Leader Coaching Behavior of Nurses in Korea: A Pilot Study.

PubMed

Ko, YuKyung; Yu, Soyoung

2017-09-01

This study was undertaken to explore the correlations among nurses' perceptions of patient safety culture, their intention to report errors, and leader coaching behaviors. The participants (N = 289) were nurses from 5 Korean hospitals with approximately 300 to 500 beds each. Sociodemographic variables, patient safety culture, intention to report errors, and coaching behavior were measured using self-report instruments. Data were analyzed using descriptive statistics, Pearson correlation coefficient, the t test, and the Mann-Whitney U test. Nurses' perceptions of patient safety culture and their intention to report errors showed significant differences between groups of nurses who rated their leaders as high-performing or low-performing coaches. Perceived coaching behavior showed a significant, positive correlation with patient safety culture and intention to report errors, i.e., as nurses' perceptions of coaching behaviors increased, so did their ratings of patient safety culture and error reporting. There is a need in health care settings for coaching by nurse managers to provide quality nursing care and thus improve patient safety. Programs that are systematically developed and implemented to enhance the coaching behaviors of nurse managers are crucial to the improvement of patient safety and nursing care. Moreover, a systematic analysis of the causes of malpractice, as opposed to a focus on the punitive consequences of errors, could increase error reporting and therefore promote a culture in which a higher level of patient safety can thrive.

Compliance and Subjective Patient Responses to Eyelid Hygiene.

PubMed

Alghamdi, Yousef A; Camp, Andrew; Feuer, William; Karp, Carol L; Wellik, Sarah; Galor, Anat

2017-07-01

Lid hygiene is a commonly prescribed first-line therapy in patients with lid margin disease, yet compliance with therapy is not well characterized. The goals of this study were to assess patient compliance with lid hygiene and evaluate which factors predict a favorable symptomatic response to treatment. This was a cross-sectional study of patients seen in the Miami Veterans Affairs eye clinic between August and December 2014. An evaluation was performed to assess dry eye symptoms and lid margin signs. All patients were then instructed to perform warm compresses and lid scrubs. A follow-up phone survey assessed compliance and subjective therapeutic response 6 weeks later. Two hundred seven of 211 (98%) patients (94% male, 60% white) completed the survey. Of the 207 patients, 188 (91%) completed the follow-up survey. Compliance with therapy was reported in 104 patients (55%); 66 reported complete improvement, 30 partial improvement, and 8 no improvement in symptoms. Patients who self-reported dry eye symptoms at first visit (n=86, 74%) were more likely to be compliant with lid hygiene than those who did not report symptoms (n=18, 25%) (P<0.0005). The only factor associated with poorer response to lid hygiene was longer time of self-reported dry eye symptoms. None of the other signs studied, including the presence of skin rosacea and lid margin telangiectasia, were associated with a differential response to lid hygiene. Patients with dry eye symptoms were moderately compliant with lid hygiene, and patients who performed the routine noted improvement in symptoms.

Patient- and Physician-reported Satisfaction With Systemic Lupus Erythematosus Treatment in US Clinical Practice.

PubMed

Pascoe, Katie; Lobosco, Steve; Bell, David; Hoskin, Ben; Chang, David J; Pobiner, Bonnie; Ramachandran, Sulabha

2017-09-01

This two-part study comprised two descriptive, cross-sectional surveys to evaluate treatment satisfaction among patients with systemic lupus erythematosus (SLE) and their physicians from US clinical practices. The Lupus Plus Project (LPP; part one) involved belimumab-containing regimens; the Disease Specific Program (DSP; part two) included all treatments and was designed to build on the body of evidence from part one. The LPP recruited patients receiving belimumab, and comprised 2 paper questionnaires: a patient self-completion questionnaire (PSC) and a patient record form (PRF) completed by the physician. The DSP enrolled patients with SLE receiving any treatment and comprised four parts: a PSC, a PRF completed by the physician after patient consultation, face-to-face physician interviews, and a workload form completed by the physicians to indicate their total SLE patient workload. The key objective of this study was to assess physician and patient satisfaction with current treatment. From the PSCs, data regarding patient-reported satisfaction with current treatment were available for 263 patients who were receiving belimumab combination therapy (LPP) and 250 patients who were receiving non-belimumab treatment (DSP). The majority of patients (belimumab, 86.3% [227/263]; non-belimumab, 78.4% [196/250]) responded positively (at least "somewhat satisfied") when asked about current treatment satisfaction, as did physicians (belimumab, 82.9% [311/375]; non-belimumab, 74.3% [326/439]). In multivariate analysis, factors most strongly associated with patient-reported satisfaction for patients receiving belimumab were patient-reported improvements in leisure activities since taking belimumab (odds ratio [OR] = 4.66), physician-reported improvements in fatigue (OR = 3.72), patient-reported improvements in general symptoms (OR = 3.02), and pain/achiness (OR = 2.71). Physician satisfaction was associated with clinical outcome such as improvements in pain/achiness (OR = 6.16), fatigue (OR = 3.76), and patient-reported satisfaction with treatment frequency (OR = 3.91). In patients receiving other SLE treatments, dosing frequency of current treatment (OR = 3.64) and a reduction in fatigue severity (OR = 3.61) were most strongly associated with patient-reported satisfaction; physician satisfaction was most strongly associated with a reduction in fatigue (OR = 6.22) and current remission status (OR = 6.05). When considering SLE treatment satisfaction patients tend to consider impact on daily functioning, whereas physicians take into account a wider range of clinical outcomes; however, both strongly consider improvements in fatigue. These surveys provide insights into treatment satisfaction among prescribers and patients with SLE. GSK-ClinicalStudyRegister.com identifiers: GSK study 202146 [HO 15-15509] and 205086 [HO 15-16709]. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

Feasibility, appropriateness, meaningfulness and effectiveness of patient participation at bedside shift reporting: mixed-method research protocol.

PubMed

Malfait, Simon; Eeckloo, Kristof; Lust, Elisa; Van Biesen, Wim; Van Hecke, Ann

2017-02-01

To evaluate the feasibility, appropriateness, meaningfulness and effectiveness of bedside shift reporting in a minimum of five interventions and five control wards. Hospitals continually improve their quality of care. Next to improvements in clinical performance, more patient participation is stimulated through different methods. Methods to enhance patient participation such as bedside shift reporting lack rigorously performed research to determine their feasibility, appropriateness, meaningfulness and effectiveness. Small-scale research and a previous pilot study indicate that bedside shift reporting improves patient participation, nurse-nurse communication and nurse-patient communication. The development, implementation and evaluation of bedside shift report are based on the Medical Research Council framework for complex interventions in health care. A matched, controlled, mixed-method, longitudinal study design will be used. The Feasibility-Appropriateness-Meaningfulness-Effectiveness framework will be applied for the quantitative and qualitative evaluation of bedside shift report. A tailored intervention and implementation process for bedside shift report will be developed using diagnostic interviews, co-design and acceptability testing. The intervention will be evaluated before implementation and three times after implementation. Individual and focus group interviews will be performed. Questionnaires, observations and analysis of the medical records and administrative databases will be completed. This study was funded in October 2015. Research Ethics Committee approval was granted in March 2016. There is a pressing need for rigorous research into the effects of interventions for improving patient participation. This study addresses the significance of bedside shift report as an intervention to improve quality of care, communication and patient participation within a large-scale, matched, controlled research design. © 2016 John Wiley & Sons Ltd.

Radiology reports for incidental thyroid nodules on CT and MRI: high variability across subspecialties.

PubMed

Grady, A T; Sosa, J A; Tanpitukpongse, T P; Choudhury, K R; Gupta, R T; Hoang, J K

2015-02-01

Variability in radiologists' reporting styles and recommendations for incidental thyroid nodules can lead to confusion among clinicians and may contribute to inconsistent patient care. Our aim was to describe reporting practices of radiologists for incidental thyroid nodules seen on CT and MR imaging and to determine factors that influence reporting styles. This is a retrospective study of patients with incidental thyroid nodules reported on CT and MR imaging between January and December 2011, identified by text search for "thyroid nodule" in all CT and MR imaging reports. The studies included CT and MR imaging scans of the neck, spine, and chest. Radiology reports were divided into those that mentioned the incidental thyroid nodules only in the "Findings" section versus those that reported the incidental thyroid nodules in the "Impression" section as well, because this latter reporting style gives more emphasis to the finding. Univariate and multivariate analyses were performed to identify radiologist, patient, and nodule characteristics that influenced reporting styles. Three hundred seventy-five patients met the criterion of having incidental thyroid nodules. One hundred thirty-eight (37%) patients had incidental thyroid nodules reported in the "Impression" section. On multivariate analysis, only radiologists' divisions and nodule size were associated with reporting in "Impression." Chest radiologists and neuroradiologists were more likely to report incidental thyroid nodules in the "Impression" section than their abdominal imaging colleagues, and larger incidental thyroid nodules were more likely to be reported in "Impression" (P ≤ .03). Seventy-three percent of patients with incidental thyroid nodules of ≥20 mm were reported in the "Impression" section, but higher variability in reporting was seen for incidental thyroid nodules measuring 10-14 mm and 15-19 mm, which were reported in "Impression" for 61% and 50% of patients, respectively. Reporting practices for incidental thyroid nodules detected on CT and MR imaging are predominantly influenced by nodule size and the radiologist's subspecialty. Reporting was highly variable for nodules measuring 10-19 mm; this finding can be partially attributed to different reporting styles among radiology subspecialty divisions. The variability demonstrated in this study further underscores the need to develop CT and MR imaging practice guidelines with the goal of standardizing reporting of incidental thyroid nodules and thereby potentially improving the consistency and quality of patient care. © 2015 by American Journal of Neuroradiology.

Comparison of Long-term Differences in Dysphagia: Cervical Arthroplasty and Anterior Cervical Fusion.

PubMed

Smucker, Joseph D; Bassuener, Scott R; Sasso, Rick C; Riew, K Daniel

2017-10-01

Retrospective cohort study. This study investigates the incidence of long-term dysphagia in cervical disc arthroplasty, and anterior cervical discectomy and fusion (ACDF) patients. No long-term comparison of dysphagia between cervical arthroplasty and fusion patients has been published. Widely variable short-term postsurgical dysphagia rates have been reported. Cohorts for this study are patients with single-level cervical degenerative disc disease previously enrolled in a randomized clinical trial comparing cervical arthroplasty and ACDF. Subjective modified Bazaz Dysphagia Severity questionnaires were distributed to each patient at a minimum of 5 years postoperative for the long-term assessment. Dysphagia severity data were pooled to compare the rate of patients with dysphagia (grade>1) to asymptomatic (grade=1). In the arthroplasty cohort, 15 of 22 (68%) patients completed long-term swallowing questionnaires with no reports of dysphagia. Eighteen of 25 (72%) ACDF patients completed questionnaires, with 5 of 18 (28%) reporting dysphagia. This is a statistically significant difference (P=0.042) favoring lower rates of long-term dysphagia after cervical arthroplasty at an average interval of 7 years postoperative (range, 5.5-8.5 y). No significant difference between rates of self-reported short-term dysphagia was noted with 12% (3/25) and 9% (2/22) in the ACDF and arthroplasty groups, respectively (P=0.56). All short-term dysphagia cases in the arthroplasty cohort reported complete resolution of symptoms within 12 months postoperative. In the ACDF cohort, persistent symptoms at 7 years were noted in all responding patients. Three ACDF patients reported new late-onset, which was not noted in the arthroplasty cohort. To date, these findings represent the longest reported follow-up interval comparing rates of dysphagia between randomized cohorts of cervical arthroplasty and fusion patients. Our study suggests that cervical arthroplasty is less likely than ACDF to cause sustained long-term or late-presenting dysphagia.

Changes in Patient Sorting to Nursing Homes under Public Reporting: Improved Patient Matching or Provider Gaming?

PubMed Central

Werner, Rachel M; Konetzka, R Tamara; Stuart, Elizabeth A; Polsky, Daniel

2011-01-01

Objective To test whether public reporting in the setting of postacute care in nursing homes results in changes in patient sorting. Data Sources/Study Setting All postacute care admissions from 2001 to 2003 in the nursing home Minimum Data Set. Study Design We test changes in patient sorting (or the changes in the illness severity of patients going to high- versus low-scoring facilities) when public reporting was initiated in nursing homes in 2002. We test for changes in sorting with respect to pain, delirium, and walking and then examine the potential roles of cream skimming and downcoding in changes in patient sorting. We use a difference-in-differences framework, taking advantage of the variation in the launch of public reporting in pilot and nonpilot states, to control for underlying trends in patient sorting. Principal Findings There was a significant change in patient sorting with respect to pain after public reporting was initiated, with high-risk patients being more likely to go to high-scoring facilities and low-risk patients more likely to go to low-scoring facilities. There was also an overall decrease in patient risk of pain with the launch of public reporting, which may be consistent with changes in documentation of pain levels (or downcoding). There was no significant change in sorting for delirium or walking. Conclusions Public reporting of nursing home quality improves matching of high-risk patients to high-quality facilities. However, efforts should be made to reduce the incentives for downcoding by nursing facilities. PMID:21105869

Caregiver Reports of Patient-Initiated Violence in Psychosis

PubMed Central

Onwumere, Juliana; Grice, Sarah; Garety, Philippa; Bebbington, Paul; Dunn, Graham; Freeman, Daniel; Fowler, David; Kuipers, Elizabeth

2014-01-01

Objective: Aggressive behaviour in psychosis is not uncommon. Community provision for people with psychosis has left informal caregivers to take on a greater role in their care. However, few studies have explored links between patient-initiated violence in mental health caregiving relationships and caregiver functioning. Our study investigated caregiver reports of aggressive acts committed by their relative with psychosis and their links to caregiver appraisals of the caregiving relationship and caregiver outcomes. Method: Caregivers of patients with a recent relapse of psychosis, recruited to a psychological therapy trial, completed the audiotaped Camberwell Family Interview at baseline. This semi-structured interview includes questions on the quality of the relationship between caregiver and patient, and patient history of violence. Seventy-two transcripts of interviews were assessed for reports of patient-initiated violence. Results: One-half of the caregiver sample (52.9%) reported an incident of patient-initiated violence during their interview; 62.2% of these involved violence toward themselves, and 24.3% toward property. Reports of patient violence were associated with caregiver ratings of hostility expressed toward patients, lower self-esteem, and emotion-focused coping. People caring on their own were more likely to report incidents of patient violence. Younger patients, males, and inpatients were more frequently identified as having a history of this kind of violence. Conclusions: Our findings suggested that caregiver reports of patient-initiated violence in psychosis are not uncommon. Mental health staff need to be aware of the risks of such violence for caregivers of people with psychosis, and consider appropriate procedures for minimizing it. Clinical Trial Registration Number: ISRCTN83557988 PMID:25007421

Rabeto plus: a valuable drug for managing functional dyspepsia.

PubMed

Ghosh, Asim; Halder, Susanta; Mandal, Sanjoy; Mandal, Arpan; Basu, Mitali; Dabholkar, Pareen

2008-11-01

The aim of the study was to evaluate and document the efficacy and tolerability of rabeto plus (FDC of rabeprazole and itopride) in management of functional dyspepsia. It was an open, prospective, non-comparative, multidose study. The patients with functional dyspepsia (NERD or non-erosive reflux disease) attending OPD of a leading, tertiary care, teaching hospital in West Bengal (BS Medical College, Bankura) were inducted in the study. A total of 46 adult patients of either sex with functional dyspepsia and a clinical diagnosis of NERD were given 1 capsule of rabeto plus before breakfast, for up to 4 weeks. Primary efficacy variables were relief from symptoms of heartburn, nausea, vomiting, waterbrash and fullness. Secondary efficacy variables were global assessment of efficacy and toleration by patients and treating physicians. The tolerability was assessed on the basis of record of spontaneously reported adverse events with their nature, intensity and outcome. Out of 55 patients enrolled in the study, 46 completed the study as planned, while 9 patients were lost to follow-up (dropped). Most patients reported near total symptom relief by the end of study. Total symptom score showed remarkable and significant improvement from baseline to end of the study. Importantly, none of the patients reported any side-effect. All participants tolerated the drug well. Moreover, response to study drug was rated as excellent or good by over 93% patients and their treating physicians. This means that 9 out 10 patients receiving rabeto plus reported desired symptom relief from dyspepsia. Thus it was concluded that rabeto plus is a valuable drug for treatment of functional dyspepsia or NERD.

People living with HIV /AIDS (PLWHA) and HIV/AIDS associated oral lesions; a study in Malaysia

PubMed Central

2012-01-01

Background The continuous increase in number of people living with HIV/AIDS (PLWHA) represents a serious health and economic burden. HIV positive individuals with oral lesions have significantly lower oral health-related quality of life than HIV positive individuals without oral lesions. The objective of this study was to assess the knowledge, attitude and practices (KAP) within a cohort of HIV/AIDS positive patients towards HIV/AIDS associated oral lesions. Methods Two hundred seventy patients attending a national referral hospital of infectious disease in Malaysia were recruited for the study. The study involved the administration of a validated interview-based questionnaire designed to elicit knowledge, attitude and practices of these patients towards HIV associated oral lesions. The last part of the questionnaire assessed the training provided to the patients in relation to the oral lesions associated with the disease and the effectiveness of this training. Data analysis was carried out using SPSS version 18. Results Thirty seven percent of patients were reported as knowledgeable, while sixty four percent reported to have positive attitude towards the care of oral hygiene. Sixty six percent of the patients reported that they would seek professional care when experiencing oral lesion. Training was reported effective for 93% patients. Conclusions Patients were non-knowledgeable in relation to oral manifestations of the disease and one third of the participating patients showed negative attitudes towards oral health care and reported various measures to manage oral lesions rather than seeking professional care. Developing effective educational methodologies can empower patients with knowledge that may translate to positive attitudes and practices. PMID:23043358

Outcomes of interfacility critical care adult patient transport: a systematic review

PubMed Central

Fan, Eddy; MacDonald, Russell D; Adhikari, Neill KJ; Scales, Damon C; Wax, Randy S; Stewart, Thomas E; Ferguson, Niall D

2006-01-01

Introduction We aimed to determine the adverse events and important prognostic factors associated with interfacility transport of intubated and mechanically ventilated adult patients. Methods We performed a systematic review of MEDLINE, CENTRAL, EMBASE, CINAHL, HEALTHSTAR, and Web of Science (from inception until 10 January 2005) for all clinical studies describing the incidence and predictors of adverse events in intubated and mechanically ventilated adult patients undergoing interfacility transport. The bibliographies of selected articles were also examined. Results Five studies (245 patients) met the inclusion criteria. All were case-series and two were prospective in design. Due to the paucity of studies and significant heterogeneity in study population, outcome events, and results, we synthesized data in a qualitative manner. Pre-transport severity of illness was reported in only one study. The most common indication for transport was a need for investigations and/or specialist care (three studies, 220 patients). Transport modalities included air (fixed or rotor wing; 66% of patients) and ground (31%) ambulance, and commercial aircraft (3%). Transport teams included a physician in three studies (220 patients). Death during transfer was rare (n = 1). No other adverse events or significant therapeutic interventions during transport were reported. One study reported a 19% (28/145) incidence of respiratory alkalosis on arrival and another study documented a 30% overall intensive care unit mortality, while no adverse events or outcomes were reported after arrival in the three other studies. Conclusion Insufficient data exist to draw firm conclusions regarding the mortality, morbidity, or risk factors associated with the interfacility transport of intubated and mechanically ventilated adult patients. Further study is required to define the risks and benefits of interfacility transfer in this patient population. Such information is important for the planning and allocation of resources related to transporting critically ill adults. PMID:16356212

Relationship between self-reported weight change, educational status, and health-related quality of life in patients with diabetes in Luxembourg.

PubMed

Tchicaya, Anastase; Lorentz, Nathalie; Demarest, Stefaan; Beissel, Jean; Wagner, Daniel R

2015-09-18

The aim of this study was to assess the relationship between self-reported weight change, socio-economic status, and health-related quality of life (HRQOL) in patients with diabetes, 5 years after they underwent coronary angiography. Between 2013 and 2014, 1873 of 4391 patients (319 with diabetes) who underwent coronary angiography between 2008 and 2009 participated in a follow-up study. Three out of four domains of the World Health Organization Quality of Life (WHOQOL)-BREF (physical health, psychological health and social relationships) were surveyed during the follow-up period. To assess the relationship between weight change and HRQOL, generalized linear models were constructed for every dimension of the WHOQOL-BREF, with educational level as a predictor and sex, age, marital status, smoking status, hypertension, cholesterol, ischemic heart disease, acute myocardial infarction, and stable angina pectoris as covariates. The mean age of the patients was 70 years and almost three-quarters of the patients (72.7 %) were men. During the 12 months preceding the follow-up survey, 22.6 % of the patients reported weight loss, 20 % reported weight gain, and 57.4 % reported no weight change. There were significant differences in the HRQOL scores between patients who reported weight loss and those who reported either weight gain or unchanged weight. The most affected domains were physical and psychological health, with higher scores for patients who reported weight loss (54.7 and 67.2, respectively) than those who reported weight gain (46.3 and 58.5, respectively). The generalized linear model confirmed higher HRQOL scores among patients who reported weight loss and revealed an association between the HRQOL score and education level. Weight change and education level were associated with HRQOL in patients with diabetes. Self-reported weight loss and no weight change were positively associated with HRQOL in patients with diabetes, while weight gain was negatively associated with HRQOL.

Dental patients' self-reports of xerostomia and associated risk factors.

PubMed

Villa, Alessandro; Polimeni, Antonella; Strohmenger, Laura; Cicciù, Domenico; Gherlone, Enrico; Abati, Silvio

2011-07-01

Most studies regarding xerostomia focus on elderly people. Therefore, the authors conducted a study of dental patients 18 years or older to determine the prevalence of self-reported xerostomia and associated risk factors. The authors sent a total of 2,200 questionnaires to four dental clinics to assess patients' self-reported xerostomia. They also collected sociodemographic data and information regarding personal behavior. They used logistic regression models to estimate odds ratios (OR) and 95 percent confidence intervals (CI) to explore the relationship between self-reported xerostomia and risk factors that reasonably might be expected to be associated with self-reported xerostomia. The overall prevalence of xerostomia in participants was 7 percent. Participants with burning-mouth sensations were associated with having higher odds of experiencing dry mouth (OR, 2.1; 95 percent CI, 0.9-5.2). Participants 51 years or older were significantly more likely to report having dry mouth than were younger participants (P < .04). The prevalence of self-reported xerostomia increased with increasing numbers of medications patients reported using. The authors found that medication use and age were highly significant risk factors for dental patients reporting xerostomia. Clinicians should interview their patients carefully regarding their use of medications and provide proper oral health care to improve xerostomia resulting from medication use.

Prevalence and correlates of self-reported sexual dysfunction in CKD: a meta-analysis of observational studies.

PubMed

Navaneethan, Sankar D; Vecchio, Mariacristina; Johnson, David W; Saglimbene, Valeria; Graziano, Giusi; Pellegrini, Fabio; Lucisano, Giuseppe; Craig, Jonathan C; Ruospo, Marinella; Gentile, Giorgio; Manfreda, Valeria Maria; Querques, Marialuisa; Stroumza, Paul; Torok, Marietta; Celia, Eduardo; Gelfman, Ruben; Ferrari, Juan Nin; Bednarek-Skublewska, Anna; Dulawa, Jan; Bonifati, Carmen; Hegbrant, Jörgen; Wollheim, Charlotta; Jannini, Emmanuele A; Strippoli, Giovanni F M

2010-10-01

Sexual dysfunction is an under-recognized problem in men and women with chronic kidney disease (CKD). The prevalence, correlates, and predictors of this condition in patients with CKD have not been evaluated comprehensively. Systematic review and meta-analysis. Patients treated using dialysis (dialysis patients), patients treated using transplant (transplant recipients), and patients with CKD not treated using dialysis or transplant (nondialysis nontransplant patients with CKD). Observational studies conducted in patients with CKD only or including a control group without CKD. Type of study population. Sexual dysfunction in men and women with CKD using validated tools, such as the International Index of Erectile Function, the Female Sexual Function Index (FSFI), or other measures as reported by study investigators. 50 studies (8,343 patients) of variable size (range, 16-1,023 patients) were included in this review. Almost all studies explored sexual dysfunction in men and specifically erectile dysfunction. The summary estimate of erectile dysfunction in men with CKD was 70% (95% CI, 62%-77%; 21 studies, 4,389 patients). Differences in reported prevalence rates of erectile dysfunction between different studies were attributable primarily to age, study populations, and type of study tool used to assess the presence of erectile dysfunction. In women, the reported prevalence of sexual dysfunction was assessed in only 306 patients from 2 studies and ranged from 30%-80%. Compared with the general population, women with CKD had a significantly lower overall FSFI score (8 studies or subgroups, 407 patients; mean difference, -9.28; 95% CI, -12.92 to -5.64). Increasing age, diabetes mellitus, and depression consistently were found to correlate with sexual dysfunction in 20 individual studies of patients with CKD using different methods. Suboptimal and lack of uniform assessment of outcome measures. Sexual dysfunction is highly prevalent in both men and women with CKD, especially among those on dialysis. Larger studies enrolling different ethnic groups, using validated study tools, and analyzing the influence of various factors on the development of sexual dysfunction are needed. Copyright © 2010 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Risk of bleeding in surgical patients treated with topical bovine thrombin sealants: a review of the literature

PubMed Central

Reynolds, Matthew W; Clark, John; Crean, Sheila; Samudrala, Srinath

2008-01-01

Background One of the most anticipated, but potentially serious complications during or after surgery are bleeding events. Among the many potential factors associated with bleeding complications in surgery, the use of bovine thrombin has been anecdotally identified as a possible cause of increased bleeding risk. Most of these reports of bleeding events in association with the use of topical bovine thrombin have been limited to case reports lacking clear cause and effect relationship determination. Recent studies have failed to establish significant differences in the rates of bleeding events between those treated with bovine thrombin and those treated with either human or recombinant thrombin. Methods We conducted a search of MEDLINE for the most recent past 10 years (1997–2007) and identified all published studies that reported a study of surgical patients with a clear objective to examine the risk of bleeding events in surgical patients. We also specifically noted the reporting of any topical bovine thrombin used during surgical procedures. We aimed to examine whether there were any differences in the risk of bleeds in general surgical populations as compared to those studies that reported exposure to topical bovine thrombin. Results We identified 21 clinical studies that addressed the risk of bleeding in surgery. Of these, 5 studies analyzed the use of bovine thrombin sealants in surgical patients. There were no standardized definitions for bleeding events employed across these studies. The rates of bleeds in the general surgery studies ranged from 0.1%–20.2%, with most studies reporting rates between 2.6%–4%. The rates of bleeding events ranged from 0.0%–13% in the bovine thrombin studies with most studies reporting between a 2%–3% rate. Conclusion The risk of bleeds was not clearly different in those studies reporting use of bovine thrombin in all patients compared to the other surgical populations studied. A well-designed and well-controlled study is needed to accurately examine the bleeding risks in surgical patients treated and unexposed to topical bovine thrombin, and to evaluate the independent risk associated with topical bovine thrombin as well as other risk factors. PMID:18348725

Patient safety challenges in a case study hospital--of relevance for transfusion processes?

PubMed

Aase, Karina; Høyland, Sindre; Olsen, Espen; Wiig, Siri; Nilsen, Stein Tore

2008-10-01

The paper reports results from a research project with the objective of studying patient safety, and relates the finding to safety issues within transfusion medicine. The background is an increased focus on undesired events related to diagnosis, medication, and patient treatment in general in the healthcare sector. The study is designed as a case study within a regional Norwegian hospital conducting specialised health care services. The study includes multiple methods such as interviews, document analysis, analysis of error reports, and a questionnaire survey. Results show that the challenges for improved patient safety, based on employees' perceptions, are hospital management support, reporting of accidents/incidents, and collaboration across hospital units. Several of these generic safety challenges are also found to be of relevance for a hospital's transfusion service. Positive patient safety factors are identified as teamwork within hospital units, a non-punitive response to errors, and unit manager's actions promoting safety.

The impact of cannabis and cannabinoids for medical conditions on health-related quality of life: A systematic review and meta-analysis.

PubMed

Goldenberg, Matthew; Reid, Mark William; IsHak, Waguih William; Danovitch, Itai

2017-05-01

The use of cannabis or cannabinoids to treat medical conditions and/or alleviate symptoms is increasingly common. However, the impact of this use on patient reported outcomes, such as health-related quality of life (HRQoL), remains unclear. We conducted a systematic review and meta-analysis, employing guidelines from Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). We categorized studies based on design, targeted disease condition, and type of cannabis or cannabinoid used. We scored studies based on quality and risk of bias. After eliminating some studies because of poor quality or insufficient data, we conducted meta-analyses of remaining studies based on design. Twenty studies met our pre-defined selection criteria. Eleven studies were randomized controlled trials (RCTs; 2322 participants); the remaining studies were of cohort and cross-sectional design. Studies of cannabinoids were mostly RCTs of higher design quality than studies of cannabis, which utilized smaller self-selected samples in observational studies. Although we did not uncover a significant association between cannabis and cannabinoids for medical conditions and HRQoL, some patients who used them to treat pain, multiple sclerosis, and inflammatory bower disorders have reported small improvements in HRQoL, whereas some HIV patients have reported reduced HRQoL. The relationship between HRQoL and the use of cannabis or cannabinoids for medical conditions is inconclusive. Some patient populations report improvements whereas others report reductions in HRQoL. In order to inform users, practitioners, and policymakers more clearly, future studies should adhere to stricter research quality guidelines and more clearly report patient outcomes. Copyright © 2017 Elsevier B.V. All rights reserved.

The effect of additional physiotherapy to hospital inpatients outside of regular business hours: a systematic review.

PubMed

Brusco, Natasha K; Paratz, Jennifer

2006-12-01

Provision of out of regular business hours (OBH) physiotherapy to hospital inpatients is widespread in the hospital setting. This systematic review evaluated the effect of additional OBH physiotherapy services on patient length of stay (LOS), pulmonary complications, discharge destination, discharge mobility status, quality of life, cost saving, adverse events, and mortality compared with physiotherapy only within regular business hours. A literature search was completed on databases with citation tracking using key words. Two reviewers completed data extraction and quality assessment independently by using modified scales for historical cohorts and case control studies as well as the PEDro scale for randomized controlled trials and quasi-randomised controlled trials. This search identified nine articles of low to medium quality. Four reported a significant reduction in LOS associated with additional OBH physiotherapy, with two articles reporting overall significance and two reporting only for specific subgroups. Two studies reported significant reduction in pulmonary complications for two different patient groups in an intensive care unit (ICU) with additional OBH physiotherapy. Three studies accounted for discharge destination and/or discharge mobility status with no significant difference reported. Quality of life, adverse events, and mortality were not reported in any studies. Cost savings were considered in three studies, with two reporting a cost saving. This systematic review was unable to conclude that the provision of additional OBH physiotherapy made significant improvement to patient outcomes for all subgroups of inpatients. One study in critical care reported that overnight physiotherapy decreased LOS and reduced pulmonary complications of patients in the ICU. However, the studies in the area of orthopaedics, neurology, postcardiac surgery, and rheumatology, which all considered additional daytime weekend physiotherapy intervention, did not provide strong evidence to indicate effective reduction in patient LOS or improving patient discharge mobility status or discharge destination. Investigation should continue in this area, but future trials should ensure factors such as random allocation, groups equal at baseline, blinded investigators, and proven intervention are included in the study design.

[Pelargonium sidoides in acute bronchitis - Health-related quality of life and patient-reported outcome in adults receiving EPs 7630 treatment].

PubMed

Matthys, Heinrich; Lizogub, Victor G; Funk, Petra; Malek, Fathi A

2010-12-01

Health-related quality of life (HRQL) and patient-reported outcome (PRO) have become important outcome parameters for the evaluation of medical treatment within clinical trials and, furthermore, to evaluate efficiency in clinical practice. We therefore report further exploratory results of an already reported dose-finding study with EPs 7630 tablets, now focussing on HRQL and PRO. A total of 406 adults with acute bronchitis were randomly assigned to one of four parallel treatment groups (placebo, 30 mg, 60 mg or 90 mg EPs 7630 daily). HRQL and PRO were assessed by questionnaires as secondary outcome measures at each study visit or daily in the patient's diary. At day 7, the patient-reported outcome measures were significantly more improved in all the three EPs 7630 groups compared to placebo (EQ-5D and EQ VAS, SF-12: physical score, impact of patient's sickness, duration of activity limitation, patient-reported treatment outcome, satisfaction with treatment). In conclusion, a statistically significant and clinically relevant improvement of HRQL/PRO compared to placebo was shown in all the three EPs 7630 groups.

Identifying Patients for Clinical Studies from Electronic Health Records: TREC 2012 Medical Records Track at OHSU

DTIC Science & Technology

2012-11-01

causes of hypertension ") AND NOT(report_text:"pulmonary| portal hypertension " OR report_text:"secondary to hypertension ") 182 Patients with Ischemic... hypertension , and tachycardia (discharge_icd_codes_txt:293.0 OR report_text:delirium) AND (discharge_icd_codes_txt:401.* OR discharge_icd_codes_txt:405...report_text:"**AGE[in teens") 162 Patients with hypertension on anti- hypertensive medication (report_text:" hypertension " OR report_text:"high blood

Dual kidney transplant techniques: A systematic review.

PubMed

Cocco, Annelise; Shahrestani, Sara; Cocco, Nicholas; Hameed, Ahmer; Yuen, Lawrence; Ryan, Brendan; Hawthorne, Wayne; Lam, Vincent; Pleass, Henry

2017-08-01

Dual kidney transplantation (DKT) was developed to improve outcomes from transplantation of extended criteria donors (ECD). This study examined which surgical techniques have been reported for DKT and whether any technique had superior patient and graft survival. Electronic databases were searched for published studies mapping to MESH terms: "kidney or renal" AND "transplan*" AND "dual or double." Single case reports, studies of patients less than 18 years old, studies which did not describe the surgical technique, and studies that did not report patient or graft survival were excluded. Fifteen reports of 434 DKT recipients were identified. Three techniques were described: bilateral placement; unilateral placement with separate anastomoses; and unilateral placement with patch anastomoses. Patient survival across all three techniques was over 95% at 1 year, and graft survival was also similar at over 90%. Rates of delayed graft function were between 20% and 30% across all techniques. The three techniques have equivalent delayed graft function as well as patient and graft survival rates. This is an encouraging result as it means that the surgeon can choose to use the technique which is most appropriate for their own skills and for the patient. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The Effectiveness of a Self-Reporting Bedside Pain Assessment Tool for Oncology Inpatients

PubMed Central

Kim, Eun Bi; Chung, Jung Hwa; Park, Bo Ram; Lim, Sung-nam; Yim, Kyoung Hoon; Shin, Young Duck; Lee, Ki Hyeong; Kim, Wun-Jae; Kim, Seung Taik

2012-01-01

Abstract Background Pain is common during cancer treatment, and patient self-reporting of pain is an essential first step for ideal cancer pain management. However, many studies on cancer pain management report that, because pain may be underestimated, it is often inadequately managed. Objective The aim of this study was to evaluate the effectiveness of bedside self-assessment of pain intensity for inpatients using a self-reporting pain board. Methods Fifty consecutive inpatients admitted to the Oncology Department of Chungbuk National University Hospital were included in this observational prospective study from February 2011 to December 2011. The medical staff performed pain assessments by asking patients questions and using verbal rated scales (VRS) over 3 consecutive days. Then, for 3 additional days, patients used a self-reporting pain board attached to the bed, which had movable indicators representing 0–10 on a numeric rating scale (NRS) and the frequency of breakthrough pain. Results Patient reliability over the medical staff's pain assessment increased from 74% to 96% after applying the self-reporting pain board (p=0.004). The gap (mean±standard deviation [SD]) between the NRS reported by patients and the NRS recorded on the medical records decreased from 3.16±2.08 to 1.00±1.02 (p<0.001), and the level of patient satisfaction with pain management increased from 54% to 82% (p=0.002). Conclusion This study suggests that the self-reporting bedside pain assessment tool provides a reliable and effective means of assessing pain in oncology inpatients. PMID:22974435

Screening for comorbid conditions in patients enrolled in the SODA registry: a 2-year observational analysis.

PubMed

Woodmansee, Whitney W; Gordon, Murray B; Molitch, Mark E; Ioachimescu, Adriana G; Carver, Don W; Mirakhur, Beloo; Cox, David; Salvatori, Roberto

2018-05-16

This 2-year analysis assessed frequency of comorbidities and comorbidity screening in the Somatuline ® (lanreotide, LAN) Depot for Acromegaly (SODA) registry. Patient data collected included pituitary hormone deficiencies, sleep studies, echocardiograms, gallbladder sonographies, colonoscopies, and glycated hemoglobin (HbA1c) levels. Insulin-like growth factor-1 (IGF-1) and growth hormone levels in patients with (DM) and without (non-DM) diabetes mellitus were analyzed. There were 241 patients enrolled. Pituitary hormone deficiencies were reported more frequently at enrollment in male (56.9%) vs female patients (32.0%; p < 0.001). TSH deficiency was the most common endocrine deficiency (69.8%), followed by gonadotropin deficiency (62.3%). Screening tests reported at enrollment: sleep studies in 29.9% (79.2% had sleep apnea), echocardiogram in 46.1% (46.8% abnormal), gallbladder sonography in 18.7% (17.8% had gallstones), and colonoscopy in 48.1% (35.3% had polyps). Follow-up studies were reported less frequently at 1 and 2 years. HbA1c data were reported in 30.8% and 41.2% after 1 and 2 years. HbA1c levels were similar at 1 and 2 years of LAN therapy among DM and non-DM patients with available data. Fewer DM vs non-DM patients achieved IGF-1 below upper limit of normal at Month 24 (58.3% vs 80.6%; p = 0.033). Fewer than half of patients in SODA had screening results reported at enrollment for sleep apnea, cardiomyopathy, and colon polyps. Gallbladder imaging was reported in a minority of patients. Lower IGF-1 control rates were observed in DM vs non-DM patients at Month 24. These data suggest a need for better monitoring of comorbidities in US acromegaly patients.

More negative self-esteem and inferior coping strategies among patients diagnosed with IBS compared with patients without IBS--a case-control study in primary care.

PubMed

Grodzinsky, Ewa; Walter, Susanna; Viktorsson, Lisa; Carlsson, Ann-Kristin; Jones, Michael P; Faresjö, Åshild

2015-01-28

Irritable Bowel Syndrome (IBS) is a chronic, relapsing gastrointestinal disorder, that affects approximately 10% of the general population and the majority are diagnosed in primary care. IBS has been reported to be associated with altered psychological and cognitive functioning such as mood disturbances, somatization, catastrophizing or altered visceral interoception by negative emotions and stress. The aim was to investigate the psychosocial constructs of self-esteem and sense of coherence among IBS patients compared to non-IBS patients in primary care. A case-control study in primary care setting among IBS patients meeting the ROME III criteria (n = 140) compared to controls i.e. non-IBS patients (n = 213) without any present or previous gastrointestinal complaints. The data were collected through self-reported questionnaires of psychosocial factors. IBS-patients reported significantly more negative self-esteem (p < 0.001), lower scores for positive self-esteem (p < 0.001), and lower sense of coherence (p < 0.001) than the controls. The IBS-cases were also less likely to report 'good' health status (p < 0.001) and less likely to report a positive belief in the future (p < 0.001). After controlling for relevant confounding factors in multiple regressions, the elevation in negative self-esteem among IBS patients remained statistically significant (p = 0.02), as did the lower scores for sense of coherence among IBS cases (p = 0.04). The more frequently reported negative self-esteem and inferior coping strategies among IBS patients found in this study suggest the possibility that psychological therapies might be helpful for these patients. However these data do not indicate the causal direction of the observed associations. More research is therefore warranted to determine whether these psychosocial constructs are more frequent in IBS patients.

Identifying patient and practice characteristics associated with patient-reported experiences of safety problems and harm: a cross-sectional study using a multilevel modelling approach.

PubMed

Ricci-Cabello, Ignacio; Reeves, David; Bell, Brian G; Valderas, Jose M

2017-11-01

To identify patient and family practice characteristics associated with patient-reported experiences of safety problems and harm. Cross-sectional study combining data from the individual postal administration of the validated Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) questionnaire to a random sample of patients in family practices (response rate=18.4%) and practice-level data for those practices obtained from NHS Digital. We built linear multilevel multivariate regression models to model the association between patient-level (clinical and sociodemographic) and practice-level (size and case-mix, human resources, indicators of quality and safety of care, and practice safety activation) characteristics, and outcome measures. Practices distributed across five regions in the North, Centre and South of England. 1190 patients registered in 45 practices purposefully sampled (maximal variation in practice size and levels of deprivation). Self-reported safety problems, harm and overall perception of safety. Higher self-reported levels of safety problems were associated with younger age of patients (beta coefficient 0.15) and lower levels of practice safety activation (0.44). Higher self-reported levels of harm were associated with younger age (0.13) and worse self-reported health status (0.23). Lower self-reported healthcare safety was associated with lower levels of practice safety activation (0.40). The fully adjusted models explained 4.5% of the variance in experiences of safety problems, 8.6% of the variance in harm and 4.4% of the variance in perceptions of patient safety. Practices' safety activation levels and patients' age and health status are associated with patient-reported safety outcomes in English family practices. The development of interventions aimed at improving patient safety outcomes would benefit from focusing on the identified groups. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Reiki for Cancer Patients Undergoing Chemotherapy in a Brazilian Hospital: A Pilot Study.

PubMed

Siegel, Pamela; da Motta, Pedro Mourão Roxo; da Silva, Luis G; Stephan, Celso; Lima, Carmen Silvia Passos; de Barros, Nelson Filice

2016-01-01

The purpose of this pilot study was to explore whether individualized Reiki given to cancer patients at a Brazilian hospital improved symptoms and well-being. Data from 36 patients who received 5 Reiki sessions were collected using the MYMOP and were compared before and after their treatment and also with 14 patients who did not receive Reiki and who acted as a comparison group. Twenty-one patients reported feeling better, 12 felt worse, and 3 reported no change. Of the comparison group, 6 patients reported feeling better and 8 felt worse. The Reiki practice delivered as part of the integrative care in oncology did produce clinically significant effects, although not statistically significant results, for more than half of the patients undergoing cancer treatment.

Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology.

PubMed

Basch, Ethan; Abernethy, Amy P; Mullins, C Daniel; Reeve, Bryce B; Smith, Mary Lou; Coons, Stephen Joel; Sloan, Jeff; Wenzel, Keith; Chauhan, Cynthia; Eppard, Wayland; Frank, Elizabeth S; Lipscomb, Joseph; Raymond, Stephen A; Spencer, Merianne; Tunis, Sean

2012-12-01

Examining the patient's subjective experience in prospective clinical comparative effectiveness research (CER) of oncology treatments or process interventions is essential for informing decision making. Patient-reported outcome (PRO) measures are the standard tools for directly eliciting the patient experience. There are currently no widely accepted standards for developing or implementing PRO measures in CER. Recommendations for the design and implementation of PRO measures in CER were developed via a standardized process including multistakeholder interviews, a technical working group, and public comments. Key recommendations are to include assessment of patient-reported symptoms as well as health-related quality of life in all prospective clinical CER studies in adult oncology; to identify symptoms relevant to a particular study population and context based on literature review and/or qualitative and quantitative methods; to assure that PRO measures used are valid, reliable, and sensitive in a comparable population (measures particularly recommended include EORTC QLQ-C30, FACT, MDASI, PRO-CTCAE, and PROMIS); to collect PRO data electronically whenever possible; to employ methods that minimize missing patient reports and include a plan for analyzing and reporting missing PRO data; to report the proportion of responders and cumulative distribution of responses in addition to mean changes in scores; and to publish results of PRO analyses simultaneously with other clinical outcomes. Twelve core symptoms are recommended for consideration in studies in advanced or metastatic cancers. Adherence to methodologic standards for the selection, implementation, and analysis/reporting of PRO measures will lead to an understanding of the patient experience that informs better decisions by patients, providers, regulators, and payers.

Surgical pathology and the patient: a systematic review evaluating the primary audience of pathology reports.

PubMed

Mossanen, Matthew; True, Lawrence D; Wright, Jonathan L; Vakar-Lopez, Funda; Lavallee, Danielle; Gore, John L

2014-11-01

The pathology report is a critical document that helps guide the management of patients with cancer. More and more patients read their reports, intending to participate in decisions about their care. However, a substantial subset of patients may lack the ability to comprehend this often technical and complex document. We hypothesized that most literature on pathology reports discusses reports from the perspective of other physicians and not from the perspective of patients. An expert panel of physicians developed a list of search criteria, which we used to identify articles on PubMed, MEDLINE, Cochrane Reviews, and Google Scholar databases. Two reviewers independently evaluated all articles to identify for detailed review those that met search criteria. We identified the primary audience of the selected articles and the degree to which these articles addressed clarity of communication of pathology reports with patients. Of 801 articles identified in our search, 25 involved the formatting of pathology reports for clarity of communication. Recurrent themes in proposed improvements in reports included content standardization, variation in terminology, clarity of communication, and quality improvement. No articles discussed patients as their target audience. No study evaluated the health literacy level required of patients to comprehend pathology reports. In summary, there is a scarcity of patient-centered approaches to improve pathology reports. The literature on pathology reports does not include patients as a target audience. Limited resources are available to help patients comprehend their reports. Efforts to improve patient-centered communication are desirable to address this overlooked aspect of patient care. Copyright © 2014 Elsevier Inc. All rights reserved.

Comparison of sinonasal quality of life and health status in patients undergoing microscopic and endoscopic transsphenoidal surgery for pituitary lesions: a prospective cohort study.

PubMed

Little, Andrew S; Kelly, Daniel F; Milligan, John; Griffiths, Chester; Prevedello, Daniel M; Carrau, Ricardo L; Rosseau, Gail; Barkhoudarian, Garni; Jahnke, Heidi; Chaloner, Charlene; Jelinek, Kathryn L; Chapple, Kristina; White, William L

2015-09-01

Despite the widespread adoption of endoscopic transsphenoidal surgery for pituitary adenomas, the sinonasal quality of life (QOL) and health status in patients who have undergone this technique have not been compared with these findings in patients who have undergone the traditional direct uninostril microsurgical technique. In this study, the authors compared the sinonasal QOL and patient-reported health status after use of these 2 surgical techniques. The study design was a nonblinded prospective cohort study. Adult patients with sellar pathology and planned transsphenoidal surgery were screened at 4 pituitary centers in the US between October 2011 and August 2013. The primary end point of the study was postoperative patient-reported sinonasal QOL as measured by the Anterior Skull Base Nasal Inventory-12 (ASK Nasal-12). Supplementary end points included patient-reported health status estimated by the 8-Item Short Form Health Survey (SF-8) and EuroQol (EQ)-5D-5L instruments, and sinonasal complications. Patients were followed for 6 months after surgery. A total of 301 patients were screened and 235 were enrolled in the study. Of these, 218 were analyzed (111 microsurgery patients, 107 endoscopic surgery patients). Demographic and tumor characteristics were similar between groups (p ≥ 0.12 for all comparisons). The most common complication in both groups was sinusitis (7% in the microsurgery group, 13% in the endoscopic surgery group; p = 0.15). Patients treated with the endoscopic technique were more likely to have postoperative nasal debridements (p < 0.001). The ASK Nasal-12 and SF-8 scores worsened substantially for both groups at 2 weeks after surgery, but then returned to baseline at 3 months. At 3 months after surgery, patients treated with endoscopy reported statistically better sinonasal QOL compared with patients treated using the microscopic technique (p = 0.02), but there were no significant differences at any of the other postoperative time points. This is the first multicenter study to examine the effect of the transsphenoidal surgical technique on sinonasal QOL and health status. The study showed that surgical technique did not significantly impact these patient-reported measures when performed at high-volume centers. Clinical trial registration no.: NCT01504399 ( clinicaltrials.gov ).

Suspected pulmonary embolism and lung scan interpretation: Trial of a Bayesian reporting method

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

Becker, D.M.; Philbrick, J.T.; Schoonover, F.W.

The objective of this research is to determine whether a Bayesian method of lung scan (LS) reporting could influence the management of patients with suspected pulmonary embolism (PE). The study is performed by the following: (1) A descriptive study of the diagnostic process for suspected PE using the new reporting method; (2) a non-experimental evaluation of the reporting method comparing prospective patients and historical controls; and (3) a survey of physicians' reactions to the reporting innovation. Of 148 consecutive patients enrolled at the time of LS, 129 were completely evaluated; 75 patients scanned the previous year served as controls. Themore » LS results of patients with suspected PE were reported as posttest probabilities of PE calculated from physician-provided pretest probabilities and the likelihood ratios for PE of LS interpretations. Despite the Bayesian intervention, the confirmation or exclusion of PE was often based on inconclusive evidence. PE was considered by the clinician to be ruled out in 98% of patients with posttest probabilities less than 25% and ruled in for 95% of patients with posttest probabilities greater than 75%. Prospective patients and historical controls were similar in terms of tests ordered after the LS (e.g., pulmonary angiography). Patients with intermediate or indeterminate lung scan results had the highest proportion of subsequent testing. Most physicians (80%) found the reporting innovation to be helpful, either because it confirmed clinical judgement (94 cases) or because it led to additional testing (7 cases). Despite the probabilistic guidance provided by the study, the diagnosis of PE was often neither clearly established nor excluded. While physicians appreciated the innovation and were not confused by the terminology, their clinical decision making was not clearly enhanced.« less

Clinicians' Reports in Electronic Health Records Versus Patients' Concerns in Social Media: A Pilot Study of Adverse Drug Reactions of Aspirin and Atorvastatin.

PubMed

Topaz, Maxim; Lai, Kenneth; Dhopeshwarkar, Neil; Seger, Diane L; Sa'adon, Roee; Goss, Foster; Rozenblum, Ronen; Zhou, Li

2016-03-01

Large databases of clinician reported (e.g., allergy repositories) and patient reported (e.g., social media) adverse drug reactions (ADRs) exist; however, whether patients and clinicians report the same concerns is not clear. Our objective was to compare electronic health record data and social media data to better understand differences and similarities between clinician-reported ADRs and patients' concerns regarding aspirin and atorvastatin. This pilot study explored a large repository of electronic health record data and social media data for clinician-reported ADRs and patients concerns for two common medications: aspirin (n = 31,817 ADRs accessible in clinical data; n = 19,186 potential ADRs accessible in social media data) and atorvastatin (n = 15,047 ADRs accessible in clinical data; n = 23,408 potential ADRs accessible in social media data). We found that the most frequently reported ADRs matched the most frequent patients' concerns. However, several less frequently reported reactions were more prevalent on social media (i.e., aspirin-induced hypoglycemia was discussed only on social media). Overall, we found a relatively strong positive and statistically significant correlation between the frequency ranking of reactions and patients' concerns for atorvastatin (Pearson's r = 0.61, p < 0.001) but not for aspirin (Pearson's r = 0.1, p = 0.69). Future studies should develop further natural language methods for a more detailed data analysis (i.e., identifying causality and temporal aspects in the social media data).

Improving the governance of patient safety in emergency care: a systematic review of interventions

PubMed Central

Hesselink, Gijs; Berben, Sivera; Beune, Thimpe

2016-01-01

Objectives To systematically review interventions that aim to improve the governance of patient safety within emergency care on effectiveness, reliability, validity and feasibility. Design A systematic review of the literature. Methods PubMed, EMBASE, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Database of Systematic Reviews and PsychInfo were searched for studies published between January 1990 and July 2014. We included studies evaluating interventions relevant for higher management to oversee and manage patient safety, in prehospital emergency medical service (EMS) organisations and hospital-based emergency departments (EDs). Two reviewers independently selected candidate studies, extracted data and assessed study quality. Studies were categorised according to study quality, setting, sample, intervention characteristics and findings. Results Of the 18 included studies, 13 (72%) were non-experimental. Nine studies (50%) reported data on the reliability and/or validity of the intervention. Eight studies (44%) reported on the feasibility of the intervention. Only 4 studies (22%) reported statistically significant effects. The use of a simulation-based training programme and well-designed incident reporting systems led to a statistically significant improvement of safety knowledge and attitudes by ED staff and an increase of incident reports within EDs, respectively. Conclusions Characteristics of the interventions included in this review (eg, anonymous incident reporting and validation of incident reports by an independent party) could provide useful input for the design of an effective tool to govern patient safety in EMS organisations and EDs. However, executives cannot rely on a robust set of evidence-based and feasible tools to govern patient safety within their emergency care organisation and in the chain of emergency care. Established strategies from other high-risk sectors need to be evaluated in emergency care settings, using an experimental design with valid outcome measures to strengthen the evidence base. PMID:26826151

Music therapy in the treatment of multiple sclerosis: a comprehensive literature review.

PubMed

Ostermann, Thomas; Schmid, Wolfgang

2006-04-01

Coping with multiple sclerosis symptoms still remains a challenge for each patient suffering from this chronic inflammatory disease. Therefore, patients often turn to using complementary and alternative medicine (CAM). In this review, the authors aimed to investigate the current state of literature of music therapy in the treatment of multiple sclerosis (MS). Medline, PubMed, Embase, AMED, CAMbase and the Music Therapy World Journal Index were searched for the terms MS and 'music therapy'. In addition, an internet search using Google Scholar was performed. The authors found seven case-reports/series and seven studies on music therapy for MS-patients. Both the case reports and studies presented here are pioneer work. Most of the studies are naturally predominated by the use of qualitative and uncontrolled research designs. Nevertheless, the results of the studies as well as the case reports demonstrate patients' improvement in the domains of self-acceptance, anxiety and depression. The results of the studies as well as the case reports define a sufficient basis for further music therapeutical work as they show a variety of psychosocial and emotional benefits for MS patients.

Standards for UNiversal reporting of patient Decision Aid Evaluation studies: the development of SUNDAE Checklist.

PubMed

Sepucha, Karen R; Abhyankar, Purva; Hoffman, Aubri S; Bekker, Hilary L; LeBlanc, Annie; Levin, Carrie A; Ropka, Mary; Shaffer, Victoria A; Sheridan, Stacey L; Stacey, Dawn; Stalmeier, Peep; Vo, Ha; Wills, Celia E; Thomson, Richard

2018-05-01

Patient decision aids (PDAs) are evidence-based tools designed to help patients make specific and deliberated choices among healthcare options. The International Patient Decision Aid Standards (IPDAS) Collaboration review papers and Cochrane systematic review of PDAs have found significant gaps in the reporting of evaluations of PDAs, including poor or limited reporting of PDA content, development methods and delivery. This study sought to develop and reach consensus on reporting guidelines to improve the quality of publications evaluating PDAs. An international workgroup, consisting of members from IPDAS Collaboration, followed established methods to develop reporting guidelines for PDA evaluation studies. This paper describes the results from three completed phases: (1) planning, (2) drafting and (3) consensus, which included a modified, two-stage, online international Delphi process. The work was conducted over 2 years with bimonthly conference calls and three in-person meetings. The workgroup used input from these phases to produce a final set of recommended items in the form of a checklist. The SUNDAE Checklist (Standards for UNiversal reporting of patient Decision Aid Evaluations) includes 26 items recommended for studies reporting evaluations of PDAs. In the two-stage Delphi process, 117/143 (82%) experts from 14 countries completed round 1 and 96/117 (82%) completed round 2. Respondents reached a high level of consensus on the importance of the items and indicated strong willingness to use the items when reporting PDA studies. The SUNDAE Checklist will help ensure that reports of PDA evaluation studies are understandable, transparent and of high quality. A separate Explanation and Elaboration publication provides additional details to support use of the checklist. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

eHealth System for Collecting and Utilizing Patient Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care) Among Cancer Patients: Mixed Methods Approach to Evaluate Feasibility and Acceptability.

PubMed

Girgis, Afaf; Durcinoska, Ivana; Levesque, Janelle V; Gerges, Martha; Sandell, Tiffany; Arnold, Anthony; Delaney, Geoff P

2017-10-02

Despite accumulating evidence indicating that collecting patient-reported outcomes (PROs) and transferring results to the treating health professional in real time has the potential to improve patient well-being and cancer outcomes, this practice is not widespread. The aim of this study was to test the feasibility and acceptability of PROMPT-Care (Patient Reported Outcome Measures for Personalized Treatment and Care), a newly developed electronic health (eHealth) system that facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions and patient self-management, and data retrieval to support ongoing evaluation and innovative research. We developed an eHealth system in consultation with content-specific expert advisory groups and tested it with patients receiving treatment or follow-up care in two hospitals in New South Wales, Australia, over a 3-month period. Participants were recruited in clinic and completed self-report Web-based assessments either just before their upcoming clinical consultation or every 4 weeks if in follow-up care. A mixed methods approach was used to evaluate feasibility and acceptability of PROMPT-Care; data collected throughout the study informed the accuracy and completeness of data transfer procedures, and extent of missing data was determined from participants' assessments. Patients participated in cognitive interviews while completing their first assessment and completed evaluation surveys and interviews at study-end to assess system acceptability and usefulness of patient self-management resources, and oncology staff were interviewed at study-end to determine the acceptability and perceived usefulness of real-time PRO reporting. A total of 42 patients consented to the study; 7 patients were withdrawn before starting the intervention primarily because of changes in eligibility. Overall, 35 patients (13 on treatment and 22 in follow-up) completed 67 assessments during the study period. Mean completeness of patient-reported data was 93%, with 100% accuracy of data transfer. Ten patients completed cognitive interviews, 28 completed evaluation surveys, and 14 completed evaluation interviews at study-end. PROMPT-Care patient acceptability was high-100% (28/28) reported the time to complete the Web-based assessments (average 15 min) as about right, most willing to answer more questions (79%, 22/28 yes), 96% (27/28) found the Web-based assessment easier or same as completing a paper copy, and they valued the self-management resources . Oncology staff (n=5) also reported high acceptability and potential feasibility of the system. Patients and oncology staff found the PROMPT-Care system to be highly acceptable, and the results suggest that it would be feasible to implement it into an oncology setting. Suggested modifications to the patient assessment survey, clinician access to the reports, and system requirements will be made as part of the next stage of large-scale testing and future implementation of the system as part of routine care. Australian New Zealand Clinical Trials Registry ACTRN1261500135294; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369299&isReview=true (Archived by WebCite at http://www.webcitation.org/6lzylG5A0). ©Afaf Girgis, Ivana Durcinoska, Janelle V Levesque, Martha Gerges, Tiffany Sandell, Anthony Arnold, Geoff P Delaney, The PROMPT-Care Program Group. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 02.10.2017.

Using Patient-Reported Information to Improve Clinical Practice.

PubMed

Schlesinger, Mark; Grob, Rachel; Shaller, Dale

2015-12-01

To assess what is known about the relationship between patient experience measures and incentives designed to improve care, and to identify how public policy and medical practices can promote patient-valued outcomes in health systems with strong financial incentives. Existing literature (gray and peer-reviewed) on measuring patient experience and patient-reported outcomes, identified from Medline and Cochrane databases; evaluations of pay-for-performance programs in the United States, Europe, and the Commonwealth countries. We analyzed (1) studies of pay-for-performance, to identify those including metrics for patient experience, and (2) studies of patient experience and of patient-reported outcomes to identify evidence of influence on clinical practice, whether through public reporting or private reporting to clinicians. First, we identify four forms of "patient-reported information" (PRI), each with distinctive roles shaping clinical practice: (1) patient-reported outcomes measuring self-assessed physical and mental well-being, (2) surveys of patient experience with clinicians and staff, (3) narrative accounts describing encounters with clinicians in patients' own words, and (4) complaints/grievances signaling patients' distress when treatment or outcomes fall short of expectations. Because these forms vary in crucial ways, each must be distinctively measured, deployed, and linked with financial incentives. Second, although the literature linking incentives to patients experience is limited, implementing pay-for-performance systems appears to threaten certain patient-valued aspects of health care. But incentives can be made compatible with the outcomes patients value if: (a) a sufficient portion of incentives is tied to patient-reported outcomes and experiences, (b) incentivized forms of PRI are complemented by other forms of patient feedback, and (c) health care organizations assist clinicians to interpret and respond to PRI. Finally, we identify roles for the public and private sectors in financing PRI and orchestrating an appropriate balance among its four forms. Unless public policies are attentive to patients' perspectives, stronger financial incentives for clinicians can threaten aspects of care that patients most value. Certain policy parameters are already clear, but additional research is required to clarify how best to collect patient narratives in varied settings, how to report narratives to consumers in conjunction with quantified metrics, and how to promote a "culture of learning" at the practice level that incorporates patient feedback. © Health Research and Educational Trust.

Cues and Concerns by Patients in Medical Consultations: A Literature Review

ERIC Educational Resources Information Center

Zimmermann, Christa; Del Piccolo, Lidia; Finset, Arnstein

2007-01-01

The aim of the current article is to review the peer-reviewed research literature on cues and concerns published between 1975 and 2006. To be included, articles had to report observational studies based on patient-physician consultations and report findings on patient expressions of cues and/or concerns. Quantitative and qualitative studies from…

Reporting mortality findings in trials of rofecoxib for Alzheimer disease or cognitive impairment: a case study based on documents from rofecoxib litigation.

PubMed

Psaty, Bruce M; Kronmal, Richard A

2008-04-16

Sponsors have a marketing interest to represent their products in the best light. This approach conflicts with scientific standards that require the symmetric and comparable reporting of safety and efficacy data. Selective reporting of the results of clinical trials can misrepresent the risk-benefit profile of drugs. We summarize how the sponsor represented mortality findings associated with rofecoxib in clinical trials of patients with Alzheimer disease or cognitive impairment. We reviewed documents that became available during litigation related to rofecoxib involving Merck & Co, including internal company analyses and information provided by the sponsor to the FDA. We also evaluated information in 2 published articles that reported results of these trials. In one article (reporting results of protocol 091) published in 2004, 11 "non-drug related deaths" were reported (9 deaths among 346 rofecoxib patients and 2 deaths among 346 placebo patients). In another article (reporting results of protocol 078) published in 2005, 39 deaths were reported among patients taking study treatment or within 14 days of the last dose (24 among 725 rofecoxib patients and 15 among 732 placebo patients) and an additional 22 deaths in the off-drug period (17 in rofecoxib patients and 5 in placebo patients). However, these articles did not include analyses or statistical tests of the mortality data, and the 2 articles concluded that regarding safety, rofecoxib is "well tolerated." In contrast, in April 2001, the company's internal intention-to-treat analyses of pooled data from these 2 trials identified a significant increase in total mortality (hazard ratio [HR], 4.43; 95% CI, 1.26-15.53 for protocol 091, and HR, 2.55; 95% CI, 1.17-5.56 for protocol 078), with overall mortality of 34 deaths among 1069 rofecoxib patients and 12 deaths among 1078 placebo patients (HR, 2.99; 95% CI, 1.55-5.77). These mortality analyses were neither provided to the FDA nor made public in a timely fashion. The data submitted by the sponsor to the FDA in a Safety Update Report in July 2001 used on-treatment analysis methods and reported 29 deaths (2.7%) among 1067 rofecoxib patients and 17 deaths (1.6%) among 1075 placebo patients. This on-treatment approach to reporting minimized the appearance of any mortality risk. In December 2001, when the FDA raised safety questions about the submitted safety data, the sponsor did not bring these issues to an institutional review board for review and revealed that there was no data and safety monitoring board for the protocol 078 study. The findings from this case study suggest that additional protections for human research participants, including new approaches for the conduct, oversight, and reporting of industry-sponsored trials, are necessary.

Diabetes quality improvement in Department of Veterans Affairs Ambulatory Care Clinics: a group-randomized clinical trial.

PubMed

Reiber, Gayle E; Au, David; McDonell, Mary; Fihn, Stephan D

2004-05-01

To conduct a group-randomized clinical trial to determine whether regular feedback to primary care providers of synthesized information on patients' health, function, and satisfaction would demonstrate improved outcomes for their patients with diabetes. Patients in General Internal Medicine Clinics Department of Veterans Affairs (VA) Medical Centers were randomized into seven intervention or control firms. Patient self-reported information was collected by mail on general health, diabetes, and up to five other chronic conditions. Patients with diabetes received the Seattle Diabetes Questionnaire, the 36-item Medical Outcomes Study short form (SF-36), and a validated patient satisfaction questionnaire at regular intervals. Data from self-report, clinical, pharmacy, and laboratory sources were synthesized into patient-specific feedback reports that intervention providers received before patients' visits. The timely delivery to primary care providers of state-of-the-art patient-feedback reports that identified patient issues and areas for improvement did not result in significant improvements in patient outcomes between the intervention and control firms. Outcomes in diabetic patients whose providers received synthesized patient data before visits were no better than in those receiving care from control firms. Future studies may benefit from substantial involvement in patients discussing, problem solving, and goal setting in addition to use of timely synthesized patient data.

Knowledge, adherence and control among patients with hypertension attending a peri-urban primary health care clinic, KwaZulu-Natal

PubMed Central

2017-01-01

Background Despite hypertension being a common condition among patients attending primary health care (PHC) clinics, blood pressure (BP) control is often poor. Greater insight into patient-related factors that influence the control of hypertension will assist in the development of an intervention to address the issues identified. Aim The aim of the study was to assess patient-related variables associated with hypertension control among patients attending a peri-urban PHC clinic. Setting The setting for this study was a peri-urban PHC clinic in KwaZulu-Natal. Method This was an observational, descriptive and cross-sectional study with 348 patients selected over a 1-month period. A validated questionnaire was used to collect data on patients’ hypertension knowledge and self-reported adherence, and BP recordings from their medical record were recorded to ascertain control. Results Of the 348 participants, only 49% had good BP control and 44% (152/348) had concurrent diabetes mellitus. The majority of patients had moderate levels of knowledge on hypertension and exhibited moderate adherence. There was a significant relationship between knowledge and reported adherence, between reported adherence and control, but not between reported knowledge and control. Conclusion Despite over 90% of the study population having moderate knowledge, and 62% with moderate reported adherence, BP was well controlled in only less than 50% of the study population. These findings suggest a need to emphasise adherence and explore new ways of approaching adherence. PMID:29113443

Mixed-Methods Evaluation of Real-Time Safety Reporting by Hospitalized Patients and Their Care Partners: The MySafeCare Application.

PubMed

Collins, Sarah A; Couture, Brittany; Smith, Ann DeBord; Gershanik, Esteban; Lilley, Elizabeth; Chang, Frank; Yoon, Cathy; Lipsitz, Stuart; Sheikh, Aziz; Benneyan, James; Bates, David W

2018-04-27

The aims of the study were to evaluate the amount and content of data patients and care partners reported using a real-time electronic safety tool compared with other reporting mechanisms and to understand their perspectives on safety concerns and reporting in the hospital. This study used mixed methods including 20-month preimplementation and postimplementation trial evaluating MySafeCare, a web-based application, which allows hospitalized patients/care partners to report safety concerns in real time. The study compared MySafeCare submission rates for three hospital units (oncology acute care, vascular intermediate care, medical intensive care) with submissions rates of Patient Family Relations (PFR) Department, a hospital service to address patient/family concerns. The study used triangulation of quantitative data with thematic analysis of safety concern submissions and patient/care partner interviews to understand submission content and perspectives on safety reporting. Thirty-two MySafeCare submissions were received with an average rate of 1.7 submissions per 1000 patient-days and a range of 0.3 to 4.8 submissions per 1000 patient-days across all units, indicating notable variation between units. MySafeCare submission rates were significantly higher than PFR submission rates during the postintervention period on the vascular unit (4.3 [95% confidence interval = 2.8-6.5] versus 1.5 [95% confidence interval = 0.7-3.1], Poisson) (P = 0.01). Overall trends indicated a decrease in PFR submissions after MySafeCare implementation. Triangulated data indicated patients preferred to report anonymously and did not want concerns submitted directly to their care team. MySafeCare evaluation confirmed the potential value of providing an electronic, anonymous reporting tool in the hospital to capture safety concerns in real time. Such applications should be tested further as part of patient safety programs.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Explanation and elaboration of the Standards for UNiversal reporting of patient Decision Aid Evaluations (SUNDAE) guidelines: examples of reporting SUNDAE items from patient decision aid evaluation literature

PubMed Central

Hoffman, Aubri S; Abhyankar, Purva; Sheridan, Stacey; Bekker, Hilary; LeBlanc, Annie; Levin, Carrie; Ropka, Mary; Shaffer, Victoria; Stacey, Dawn; Stalmeier, Peep; Vo, Ha; Wills, Celia; Thomson, Richard

2018-01-01

This Explanation and Elaboration (E&E) article expands on the 26 items in the Standards for UNiversal reporting of Decision Aid Evaluations guidelines. The E&E provides a rationale for each item and includes examples for how each item has been reported in published papers evaluating patient decision aids. The E&E focuses on items key to reporting studies evaluating patient decision aids and is intended to be illustrative rather than restrictive. Authors and reviewers may wish to use the E&E broadly to inform structuring of patient decision aid evaluation reports, or use it as a reference to obtain details about how to report individual checklist items. PMID:29467235

Patient-rated versus proxy-rated cognitive and functional measures in older adults

PubMed Central

Howland, Molly; Allan, Kevin C; Carlton, Caitlin E; Tatsuoka, Curtis; Smyth, Kathleen A; Sajatovic, Martha

2017-01-01

Objectives Patients with cognitive impairment may have difficulty reporting their functional and cognitive abilities, which are important clinical outcomes. Health care proxies may be able to corroborate patient self-reports. Several studies reported discrepancy between patient and proxy ratings, though the literature is sparse on changes over time of these ratings. Our goals in this 12-month study were to compare patient and proxy reports on functioning, cognition, and everyday executive function, and to further elucidate correlates of patient–proxy discrepancy. Methods This was a prospective cohort study of individuals older than 70 years who ranged from having no cognitive impairment to having moderate dementia who had a proxy available to complete instruments at baseline (N=76). Measurements included Alzheimer’s Disease Cooperative Study–Activities of Daily Living Inventory (ADCS-ADLI), Neuro-QOL Executive Function, PROMIS Applied Cognition (PROMIS-Cog), Mini-Mental State Examination (MMSE), and Geriatric Depression Scale. Results Patient- and proxy-rated ADCS-ADLI were correlated at baseline and at 1-year follow-up. Patient and proxy ratings were discrepant on Neuro-QOL Executive Function and PROMIS-Cog. Greater patient–proxy discrepancy on PROMIS-Cog was associated with younger age and less depression, and greater patient–proxy discrepancy on Neuro-QOL Executive Function was associated with less depression and worse cognitive impairment. Patient–proxy discrepancy increased over time for everyday executive function. Changes in proxy-rated but not patient-rated ADCS-ADLI correlated with MMSE changes. Conclusion Patients and proxies generally agree in reporting on activities of daily living. Patient and proxy reports differ in their respective evaluation of cognitive functioning and everyday executive function. Ratings from both sources may be preferred for these two domains, though studies using gold standard measures are necessary. It is important that clinicians are aware of the differences between patient and proxy perspective to create an accurate clinical picture and guide treatment. PMID:28352208

[Clinical assessment of olfactory performance - why patient interviews are not enough : A report on lessons learned in planning studies with anosmic patients].

PubMed

Schöpf, V; Kollndorfer, K

2015-07-01

Olfactory dysfunction and loss of smell are mostly associated with an immense decrease in the quality of life. The aim of the presented study was to report on particularities in the acquisition of patients with olfactory dysfunction. During July 2011 and May 2014 we were contacted by 300 potential patients with self-reported loss of smell, 95 (54 female, 41 male, mean age 53) of which were invited for clinical testing after phone interviews. Clinical smell testing revealed 46 patients with anosmia, 38 with hyposmia, and 11 with normosmia. Self-assessment of olfactory function only correlated with clinical scores if patients had nearly no olfactory function left. The ability of self-assessment of olfactory function was independent of age or sex. Further, most patients were not able to report on the reason for or the duration of their olfactory dysfunction. Our report shows that patients with olfactory dysfunction are hardly ever ably to assess their grade of performance reduction. Awareness among patients with a reduced sense of smell is of great general importance, since it can be an indicator of neurodegenerative diseases. This should especially be noted for patients older than 50 who are not able to indicate a reason for their loss of smell.

Treating Pain in Pregnancy with Acupuncture: Observational Study Results from a Free Clinic in New Zealand.

PubMed

Soliday, Elizabeth; Betts, Debra

2018-02-01

Clinic-based acupuncturists, midwives, and physiotherapists have reported using acupuncture to treat lumbopelvic pain in pregnancy, a common condition that may affect functioning and quality of life. To contribute to the emerging evidence on treatment outcomes, we collected patient-reported pain reduction data from women treated during pregnancy in a no-pay, hospital-based acupuncture service in New Zealand. Observational study of patient-reported symptom reduction.The main outcome measure was the MYMOP (Measure Your Medical Outcome Profile), a brief, validated self-report instrument. Open-ended questions on treatment experiences and adverse events were included. Of the 81 women on whom we had complete treatment data, the majority (N = 72, 89%) reported clinically meaningful symptom reduction. Patient-reported adverse events were infrequent and mild. Patient-reported and treatment-related lumbopelvic pain symptom reduction findings provide further evidence that acupuncture in pregnancy is safe and beneficial in a field setting. We discuss this study's unique contributions in providing guidance for clinicians who practice acupuncture in pregnancy, including midwives, physiotherapists, and physicians. Copyright © 2018. Published by Elsevier B.V.

[Patient safety: a comparison between handwritten and computerized voluntary incident reporting].

PubMed

Capucho, Helaine Carneiro; Arnas, Emilly Rasquini; Cassiani, Silvia Helena De Bortoli

2013-03-01

This study's objective was to compare two types of voluntary incident reporting methods that affect patient safety, handwritten (HR) and computerized (CR), in relation to the number of reports, type of incident reported the individual submitting the report, and quality of reports. This was a descriptive, retrospective and cross-sectional study. CR were more frequent than HR (61.2% vs. 38.6%) among the 1,089 reports analyzed and were submitted every day of the month, while HR were submitted only on weekdays. The highest number of reports referred to medication, followed by problems related to medical-hospital material and the professional who most frequently submitted reports were nurses in both cases. Overall CR presented higher quality than HR (86.1% vs. 61.7%); 36.8% of HR were illegible, a problem that was eliminated in CR. Therefore, the use of computerized incident reporting in hospitals favors qualified voluntary reports, increasing patient safety.

The patient perspective on remote monitoring of patients with an implantable cardioverter defibrillator: Narrative review and future directions.

PubMed

Timmermans, Ivy; Meine, Matias; Zitron, Edgar; Widdershoven, Jos; Kimman, Geert; Prevot, Sébastien; Rauwolf, Thomas; Anselme, Frédéric; Szendey, Istvan; Romero Roldán, Javier; Mabo, Philippe; Schaer, Beat; Denollet, Johan; Versteeg, Henneke

2017-07-01

Studies have shown that remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICDs) is at least comparable to in-clinic follow-up with regard to clinical outcomes and might be cost-effective, yet RPM is not standard clinical practice within Europe. Better insight into the patient perspective on RPM may aid in its acceptance, implementation, and reimbursement. This narrative review (1) summarizes existing evidence on the impact of RPM on patient-reported outcomes and (2) discusses future directions in examining the patient perspective. Literature review indicated that only five randomized trials on RPM in ICD patients included patient-reported outcomes, with inconclusive results. Observational studies show a trend toward good patient satisfaction and acceptation of RPM. Yet, results should be interpreted with caution due to a number of limitations including a potential selection bias, use of generic/nonvalidated questionnaires, relatively short follow-up durations, and a lack of subgroup identification. Although RPM seems to be safe, effective, timely, and efficient, the patient perspective has received little attention so far. The scarce evidence on patient-reported outcomes in RPM studies seems to be positive, but future trials with a follow-up of ≥12 months and validated patient-reported outcome measures are needed. The REMOTE-CIED study from our group is the first prospective randomized controlled trial primarily designed to examine the patient perspective on RPM, and is powered to identify characteristics associated with RPM satisfaction and benefit. Results are expected in 2018 and will add valuable information to the current evidence. © 2017 Wiley Periodicals, Inc.

A new podiatry service for patients with arthritis.

PubMed

Rome, Keith; Erikson, Kathryn; Ng, Anthony; Gow, Peter J; Sahid, Hazra; Williams, Anita E

2013-03-01

The aims of this study were to identify the impact of a new podiatric rheumatology service on reducing foot pain, impairment and disability in patients with foot problems associated with rheumatic disease, and to report on patient satisfaction with the service. A retrospective study of 245 patients with rheumatic disease at Counties Manukau DHB was conducted. Foot pain, impairment and disability were measured using a self-reporting patient outcome measure, the Foot Function Index. A range of podiatric interventions were reported. A self-administered, postal patient satisfaction questionnaire was sent to 148 patients. Over two-thirds of patients were observed with hallux valgus (bunions). The results demonstrate a significant reduction in foot pain (p<0.001) from initial visit to second visit (18% reduction in pain). A significant decrease in foot disability (p=0.04) was found from initial visit to second visit. No significant differences were seen with foot impairment (p=0.78). A variety of intervention measures were used with 24% of patients being prescribed foot orthoses and 28% of patients given footwear advice. The patient satisfaction survey found 84% of patients reported they were satisfied with the new service and 80% of patients reported that the service helped with their foot problems. The current service meets the needs of patients who suffer from rheumatological foot conditions such as rheumatoid arthritis and gout. The need for good foot education, provision of foot orthoses and advice on footwear are crucial to reduce the burden on patients with rheumatological foot conditions.

Long-Term, Open-Label Safety and Efficacy of Atomoxetine in Adults with ADHD: Final Report of a 4-Year Study

ERIC Educational Resources Information Center

Adler, Lenard A.; Spencer, Thomas J.; Williams, David W.; Moore, Rodney J.; Michelson, David

2008-01-01

Objective: Previously, data from 97 weeks of open-label atomoxetine treatment of adults with attention-deficit/hyperactivity disorder (ADHD) were reported. This final report of that study presents results from over 4 years of treatment. Method: Results were derived from the study of 384 patients (125 patients remaining in the open-label trial…

Designing a valid randomized pragmatic primary care implementation trial: the my own health report (MOHR) project.

PubMed

Krist, Alex H; Glenn, Beth A; Glasgow, Russell E; Balasubramanian, Bijal A; Chambers, David A; Fernandez, Maria E; Heurtin-Roberts, Suzanne; Kessler, Rodger; Ory, Marcia G; Phillips, Siobhan M; Ritzwoller, Debra P; Roby, Dylan H; Rodriguez, Hector P; Sabo, Roy T; Sheinfeld Gorin, Sherri N; Stange, Kurt C

2013-06-25

There is a pressing need for greater attention to patient-centered health behavior and psychosocial issues in primary care, and for practical tools, study designs and results of clinical and policy relevance. Our goal is to design a scientifically rigorous and valid pragmatic trial to test whether primary care practices can systematically implement the collection of patient-reported information and provide patients needed advice, goal setting, and counseling in response. This manuscript reports on the iterative design of the My Own Health Report (MOHR) study, a cluster randomized delayed intervention trial. Nine pairs of diverse primary care practices will be randomized to early or delayed intervention four months later. The intervention consists of fielding the MOHR assessment--addresses 10 domains of health behaviors and psychosocial issues--and subsequent provision of needed counseling and support for patients presenting for wellness or chronic care. As a pragmatic participatory trial, stakeholder groups including practice partners and patients have been engaged throughout the study design to account for local resources and characteristics. Participatory tasks include identifying MOHR assessment content, refining the study design, providing input on outcomes measures, and designing the implementation workflow. Study outcomes include the intervention reach (percent of patients offered and completing the MOHR assessment), effectiveness (patients reporting being asked about topics, setting change goals, and receiving assistance in early versus delayed intervention practices), contextual factors influencing outcomes, and intervention costs. The MOHR study shows how a participatory design can be used to promote the consistent collection and use of patient-reported health behavior and psychosocial assessments in a broad range of primary care settings. While pragmatic in nature, the study design will allow valid comparisons to answer the posed research question, and findings will be broadly generalizable to a range of primary care settings. Per the pragmatic explanatory continuum indicator summary (PRECIS) framework, the study design is substantially more pragmatic than other published trials. The methods and findings should be of interest to researchers, practitioners, and policy makers attempting to make healthcare more patient-centered and relevant. Clinicaltrials.gov: NCT01825746.

Associations Between Patient Perceptions of Communication, Cure, and Other Patient-Related Factors Regarding Patient-Reported Quality of Care Following Surgical Resection of Lung and Colorectal Cancer.

PubMed

Ejaz, Aslam; Kim, Yuhree; Winner, Megan; Page, Andrew; Tisnado, Diana; Dy, Sydney E Morss; Pawlik, Timothy M

2016-04-01

The objective of the current study was to analyze various patient-related factors related to patient-reported quality of overall and surgical care following surgical resection of lung or colorectal cancer. Between 2003 and 2005, 3,954 patients who underwent cancer-directed surgery for newly diagnosed lung (30.3%) or colorectal (69.7%) cancer were identified from a population- and health system-based survey of participants from multiple US regions. Factors associated with patient-perceived quality of overall and surgical care were analyzed with multivariable logistic regression models. Overall, 56.7% of patients reported excellent quality of overall care and 67.9% of patients reported excellent quality of surgical care; there was no difference by cancer type (P > 0.05). Factors associated with lower likelihood to report excellent quality of overall and surgical care included female sex, minority race, and the presence of multiple comorbidities (all odds ratio [OR] <1, all P < 0.05). Patients who had higher levels of education (overall quality: OR 1.62; surgical quality: OR 1.26), higher annual income (overall quality: OR 1.29; surgical quality: OR 1.23), and good physical function (overall quality: OR 1.35; surgical quality: OR 1.24) were all more likely to report excellent quality of overall and surgical care (all P < 0.05). Furthermore, patients who reported their physician as having excellent communication skills (overall quality: OR 6.49; surgical quality: OR 3.74) as well as patients who perceived their cancer as likely curable (overall quality: OR 1.17; surgical quality: OR 1.11) were more likely to report excellent quality of overall and surgical care (all P < 0.05). Patient-reported quality of care is associated with several factors including race, income, and educational status, as well as physician communication and patient perception of likelihood of cure. Future studies are needed to more closely examine patient-physician relationships and communication barriers, particularly among minority patients and those with lower income and educational status.

Recurrence rate and patient satisfaction of CO2 laser evaporation of lesions in patients with hidradenitis suppurativa: a retrospective study.

PubMed

Mikkelsen, Peter Riis; Dufour, Deirde Nathalie; Zarchi, Kian; Jemec, Gregor B E

2015-02-01

Hidradenitis suppurativa (HS) is a debilitating disease and is difficult to treat. Validation of surgical techniques is therefore of great importance in the management of HS. Carbon dioxide (CO2) laser evaporation has been shown effective, but larger-scale studies are scarce. To determine the recurrence rate, time to recurrence, and factors influencing disease recurrence in skin treated with CO2 laser evaporation, and healing by secondary intention; and patients' satisfaction with treatment. Fifty-eight patients treated with CO2 laser evaporation were interviewed regarding recurrence and satisfaction after a mean of 25.7 months. Seventeen of 58 (29%) reported recurrence of HS lesions within the borders of the treated areas after a mean of 12.7 months. Obesity was a risk factor for recurrence with a hazard ratio of 4.53. Fifty-five patients (95%) reported some or great improvement, and 91% would recommend the CO2 laser surgery to other HS patients. This study supports the claim that CO2 laser treatment is an effective modality for recurrent HS lesions in a majority of patients. The authors identified obesity as a risk factor for recurrence. Self-reported satisfaction is high, and only 3 of 58 report no change in the condition. None reported a worsening.

Exploring the Influence of Nurse Work Environment and Patient Safety Culture on Attitudes Toward Incident Reporting.

PubMed

Yoo, Moon Sook; Kim, Kyoung Ja

2017-09-01

The aim of this study was to explore the influence of nurse work environments and patient safety culture on attitudes toward incident reporting. Patient safety culture had been known as a factor of incident reporting by nurses. Positive work environment could be an important influencing factor for the safety behavior of nurses. A cross-sectional survey design was used. The structured questionnaire was administered to 191 nurses working at a tertiary university hospital in South Korea. Nurses' perception of work environment and patient safety culture were positively correlated with attitudes toward incident reporting. A regression model with clinical career, work area and nurse work environment, and patient safety culture against attitudes toward incident reporting was statistically significant. The model explained approximately 50.7% of attitudes toward incident reporting. Improving nurses' attitudes toward incident reporting can be achieved with a broad approach that includes improvements in work environment and patient safety culture.

No associations between self-reported knee joint instability and radiographic features in knee osteoarthritis patients prior to Total Knee Arthroplasty: A cross-sectional analysis of the Longitudinal Leiden Orthopaedics Outcomes of Osteo-Arthritis study (LOAS) data.

PubMed

Leichtenberg, Claudia S; Meesters, Jorit J L; Kroon, Herman M; Verdegaal, Suzan H M; Tilbury, Claire; Dekker, Joost; Nelissen, Rob G H H; Vliet Vlieland, Thea P M; van der Esch, Martin

2017-08-01

To describe the prevalence of self-reported knee joint instability in patients with pre-surgery knee osteoarthritis (OA) and to explore the associations between self-reported knee joint instability and radiological features. A cross-sectional study including patients scheduled for primary Total Knee Arthroplasty (TKA). Self-reported knee instability was examined by questionnaire. Radiological features consisted of osteophyte formation and joint space narrowing (JSN), both scored on a 0 to three scale. Scores >1 are defined as substantial JSN or osteophyte formation. Regression analyses were provided to identify associations of radiological features with self-reported knee joint instability. Two hundred and sixty-five patients (mean age 69years and 170 females) were included. Knee instability was reported by 192 patients (72%). Substantial osteophyte formation was present in 78 patients (41%) reporting and 33 patients (46%) not reporting knee joint instability. Substantial JSN was present in 137 (71%) and 53 patients (73%), respectively. Self-reported knee instability was not associated with JSN (relative to score 0, odds ratios (95% CI) of score 1, 2 and 3 were 0.87 (0.30-2.54), 0.98 (0.38-2.52), 0.68 (0.25-1.86), respectively) or osteophyte formation (relative to score 0, odds ratios (95% CI) of score 1, 2 and 3 were 0.77 (0.36-1.64), 0.69 (0.23-1.45), 0.89 (0.16-4.93), respectively). Stratified analysis for pain, age and BMI showed no associations between self-reported knee joint instability and radiological features. Self-reported knee joint instability is not associated with JSN or osteophyte formation. Copyright © 2017 Elsevier B.V. All rights reserved.

General practitioners’ attitudes towards the management of dental conditions and use of antibiotics in these consultations: a qualitative study

PubMed Central

Cope, Anwen L; Wood, Fiona; Francis, Nick A; Chestnutt, Ivor G

2015-01-01

Objectives This study aimed to produce an account of the attitudes of general practitioners (GPs) towards the management of dental conditions in general practice, and sought to explore how GPs use antibiotics in the treatment of dental problems. Design Qualitative study employing semistructured telephone interviews and thematic analysis. Participants 17 purposively sampled GPs working in Wales, of which 9 were male. The median number of years since graduation was 21. Maximum variation sampling techniques were used to ensure participants represented different Rural–Urban localities, worked in communities with varying levels of deprivation, and had differing lengths of practising career. Results Most GPs reported regularly managing dental problems, with more socioeconomically deprived patients being particularly prone to consult. Participants recognised that dental problems are not optimally managed in general practice, but had sympathy with patients experiencing dental pain who reported difficulty obtaining an emergency dental consultation. Many GPs considered antibiotics an acceptable first-line treatment for acute dental problems and reported that patients often attended expecting to receive antibiotics. GPs who reported that their usual practice was to prescribe antibiotics were more likely to prioritise patients’ immediate needs, whereas clinicians who reported rarely prescribing often did so to encourage patients to consult a dental professional. Conclusions The presentation of patients with dental problems presents challenges to GPs who report concerns about their ability to manage such conditions. Despite this, many reported frequently prescribing antibiotics for patients with dental conditions. This may contribute to both patient morbidity and the emergence of antimicrobial resistance. This research has identified the need for quantitative data on general practice consultations for dental problems and qualitative research exploring patient perspectives on reasons for consulting. The findings of these studies will inform the design of an intervention to support patients in accessing appropriate care when experiencing dental problems. PMID:26428331

The prevalence of patient engagement in published trials: a systematic review.

PubMed

Fergusson, Dean; Monfaredi, Zarah; Pussegoda, Kusala; Garritty, Chantelle; Lyddiatt, Anne; Shea, Beverley; Duffett, Lisa; Ghannad, Mona; Montroy, Joshua; Hassan Murad, M; Pratt, Misty; Rader, Tamara; Shorr, Risa; Yazdi, Fatemeh

2018-01-01

With the growing movement to engage patients in research, questions are being asked about who is engaging patients and how they are being engaged. Internationally, research groups are supporting and funding patient-oriented research studies that engage patients in the identification of research priorities and the design, conduct and uptake of research. As we move forward, we need to know what meaningful patient engagement looks like, how it benefits research and clinical practice, and what are the barriers to patient engagement?We conducted a review of the published literature looking for trials that report engaging patients in the research. We included both randomized controlled trials and non-randomized comparative trials. We looked at these trials for important study characteristics, including how patients were engaged, to better understand the practices used in trials. Importantly, we also discuss the number of trials reporting patient engagement practices relative to all published trials. We found that very few trials report any patient engagement activities even though it is widely supported by many major funding organizations. The findings of our work will advance patient-oriented research by showing how patients can be engaged and by stressing that patient engagement practices need to be better reported. Patient-Oriented Research (POR) is research informed by patients and is centred on what is of importance to them. A fundamental component of POR is that patients are included as an integral part of the research process from conception to dissemination and implementation, and by extension, across the research continuum from basic research to pragmatic trials [J Comp Eff Res 2012, 1:181-94, JAMA 2012, 307:1587-8]. Since POR's inception, questions have been raised as to how best to achieve this goal.We conducted a systematic review of randomized controlled trials and non-randomized comparative trials that report engaging patients in their research. Our main goal was to describe the characteristics of published trials engaging patients in research, and to identify the extent of patient engagement activities reported in these trials. The MEDLINE®, EMBASE®, Cinahl, PsycINFO, Cochrane Methodology Registry, and Pubmed were searched from May 2011 to June 16th, 2016. Title, abstract and full text screening of all reports were conducted independently by two reviewers. Data were extracted from included trials by one reviewer and verified by a second. All trials that report patient engagement for the purposes of research were included. Of the 9490 citations retrieved, 2777 were reviewed at full text, of which 23 trials were included. Out of the 23 trials, 17 were randomized control trials, and six were non-randomized comparative trials. The majority of these trials (83%, 19/23) originated in the United States and United Kingdom. The trials engaged a range of 2-24 patients/ community representatives per study. Engagement of children and minorities occurred in 13% (3/23) and 26% (6/23) of trials; respectively. Engagement was identified in the development of the research question, the selection of study outcomes, and the dissemination and implementation of results. The prevalence of patient engagement in patient-oriented interventional research is very poor with 23 trials reporting activities engaging patients. Research dedicated to determining the best practice for meaningful engagement is still needed, but adequate reporting measures also need to be defined.

Do Parkinson's disease patients disclose their adverse events spontaneously?

PubMed

Perez-Lloret, Santiago; Rey, María Verónica; Fabre, Nelly; Ory, Fabienne; Spampinato, Umberto; Montastruc, Jean-Louis; Rascol, Olivier

2012-05-01

Underreporting of adverse drug reactions is common but has been rarely studied in Parkinson's disease (PD). To compare the prevalence of adverse events (AEs) in relation to antiparkinsonian drugs in PD patients using two different data collection methods: patient's spontaneous reporting versus a predefined investigator-driven structured interview. Secondary objectives were to assess factors related to spontaneous reporting and to compare the rate of AE reporting in PD patients with that of a group of non-parkinsonian post-stroke patients. Cross-sectional study. Ambulatory, cognitively intact PD or post-stroke outpatients. None. Patients were first asked by means of an an open question to disclose any unpleasant effects in connection with their current medications that had occurred during the previous week. Afterwards, a predefined questionnaire listing the most common AEs known to be related to antiparkinsonian drugs was used to question the same patients in a systematic manner about the presence of any AE during the same week. Chronological and semiological criteria were used to classify the reported AEs as "unrelated" or "possibly/plausibly related" to the antiparkinsonian treatment. A total of 203 PD and 52 post-stroke patients of comparable age and sex were recruited. Eighty-five PD and five post-stroke patients reported spontaneously at least one AE (42 vs. 10%, p < 0.01), while 203 PD and 47 post-stroke patients reported at least one AE following the structured questionnaire (100 vs. 90%, p < 0.001). In PD patients, there were a total of 112 spontaneously reported AEs as compared with 1,574 according to the structured questionnaire (7%). Spontaneous disclosure of AEs was associated with experiencing >2 AEs [OR = 1.2 (1.1-3.2)], logistic regression). Seventy-four percent of PD patients had ≥1 AE possibly/plausibly related to antiparkinsonian drugs. Results showed that only 7% of AEs were reported spontaneously by patients, thus underscoring the importance of systematically asking about AEs in PD patients.

Impact of the age of stored blood on trauma patient mortality: a systematic review

PubMed Central

Sowers, Nicholas; Froese, Patrick C.; Erdogan, Mete; Green, Robert S.

2015-01-01

Background The impact of the age of stored red blood cells on mortality in patients sustaining traumatic injuries requiring transfusion of blood products is unknown. The objective of this systematic review was to identify and describe the available literature on the use of older versus newer blood in trauma patient populations. Methods We searched PubMed, Embase, Lilac and the Cochrane Database for published studies comparing the transfusion of newer versus older red blood cells in adult patients sustaining traumatic injuries. Studies included for review reported on trauma patients receiving transfusions of packed red blood cells, identified the age of stored blood that was transfused and reported patient mortality as an end point. We extracted data using a standardized form and assessed study quality using the Newcastle–Ottawa Scale. Results Seven studies were identified (6780 patients) from 3936 initial search results. Four studies reported that transfusion of older blood was independently associated with increased mortality in trauma patients, while 3 studies did not observe any increase in patient mortality with the use of older versus newer blood. Three studies associated the transfusion of older blood with adverse patient outcomes, including longer stay in the intensive care unit, complicated sepsis, pneumonia and renal dysfunction. Studies varied considerably in design, volumes of blood transfused and definitions applied for old and new blood. Conclusion The impact of the age of stored packed red blood cells on mortality in trauma patients is inconclusive. Future investigations are warranted. PMID:26384149

Patient-Reported Expedited Partner Therapy for Gonorrhea in the United States: Findings of the STD Surveillance Network 2010-2012.

PubMed

Stenger, Mark R; Kerani, Roxanne P; Bauer, Heidi M; Burghardt, Nicole; Anschuetz, Greta L; Klingler, Ellen; Schumacher, Christina M; Simon, Julie; Golden, Matthew

2015-09-01

Expedited partner therapy (EPT) has been shown to prevent reinfection in persons with gonorrhea and to plausibly reduce incidence. The Centers for Disease Control and Prevention recommends EPT as an option for treating sex partners of heterosexual patients. Few studies that examine how the reported use of this valuable intervention differs by patient and provider characteristics and by geography across multiple jurisdictions in the United States are currently available. Case and patient interview data were obtained for a random sample of reported cases from 7 geographically disparate US jurisdictions participating in the Sexually Transmitted Disease (STD) Surveillance Network. These data were weighted to be representative of all reported gonorrhea cases in the 7 study sites. Patient receipt of EPT was estimated, and multivariate models were constructed separately to examine factors associated with receipt of EPT for heterosexuals and for men who have sex with men. Overall, 5.4% of patients diagnosed and reported as having gonorrhea reported receiving EPT to treat their sex partners. Heterosexual patients were more likely to have received EPT than men who have sex with men at 6.6% and 2.6% of patients, respectively. Receipt of EPT did not vary significantly by race, Hispanic ethnicity, or age for either group, although significant variation was observed in different provider settings, with patients from family planning/reproductive health and STD clinic settings more likely to report receiving EPT. Jurisdiction variations were also observed with heterosexual patients in Washington State most likely (35.5%), and those in New York City, Connecticut, and Philadelphia least likely to report receiving EPT (<2%). With the exception of one jurisdiction in the STD Surveillance Network actively promoting EPT use, patient-reported receipt of the intervention remains suboptimal across the network. Additional efforts to promote EPT, especially for patients diagnosed in private provider and hospital settings, are needed to realize the full potential of this valuable gonorrhea control intervention.

What can patients tell us about the quality and safety of hospital care? Findings from a UK multicentre survey study.

PubMed

O'Hara, Jane K; Reynolds, Caroline; Moore, Sally; Armitage, Gerry; Sheard, Laura; Marsh, Claire; Watt, Ian; Wright, John; Lawton, Rebecca

2018-03-15

Patient safety measurement remains a global challenge. Patients are an important but neglected source of learning; however, little is known about what patients can add to our understanding of safety. We sought to understand the incidence and nature of patient-reported safety concerns in hospital. Feedback about the experience of safety within hospital was gathered from 2471 inpatients as part of a multicentre, waitlist cluster randomised controlled trial of an intervention, undertaken within 33 wards across three English NHS Trusts, between May 2013 and September 2014. Patient volunteers, supported by researchers, developed a classification framework of patient-reported safety concerns from a random sample of 231 reports. All reports were then classified using the patient-developed categories. Following this, all patient-reported safety concerns underwent a two-stage clinical review process for identification of patient safety incidents. Of the 2471 inpatients recruited, 579 provided 1155 patient-reported incident reports. 14 categories were developed for classification of reports, with communication the most frequently occurring (22%), followed by staffing issues (13%) and problems with the care environment (12%). 406 of the total 1155 patient incident reports (35%) were classified by clinicians as a patient safety incident according to the standard definition. 1 in 10 patients (264 patients) identified a patient safety incident, with medication errors the most frequently reported incident. Our findings suggest that patients can provide insight about safety that complements existing patient safety measurement, with a frequency of reported patient safety incidents that is similar to those obtained via case note review. However, patients provide a unique perspective about hospital safety which differs from and adds to current definitions of patient safety incidents. ISRCTN07689702; pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Incidence and diagnosis of heparin-induced thrombocytopenia (HIT) in patients with traumatic injuries treated with unfractioned or low-molecular-weight heparin: a literature review.

PubMed

Bloemen, A; Testroote, M J G; Janssen-Heijnen, M L G; Janzing, H M J

2012-05-01

The incidence of thromboembolic complications after major traumatic injuries is high (>50%). Thromboprophylaxis, often by low-molecular-weight heparin (LMWH) or unfractioned heparin (UH) is therefore routinely administered. Thromboprophylaxis is also advised after immobilisation for isolated lower leg injuries. Heparin induced thrombocytopenia (HIT) is a rare but very serious immune mediated complication of treatment with LMWH, which can cause potentially fatal thromboembolism. In the general medical and surgical population the incidence of HIT is 0.2%. Little is known about the incidence of HIT and value of screening in trauma patients and in isolated lower extremity injuries. Therefore, we performed a systematic literature review. The online databases Medline and EMBASE were searched independently by two authors. Manuscripts were selected for analysis by quantitative and qualitative selection. After eliminating duplicate articles and irrelevant studies, seven relevant papers reporting on the incidence of HIT in trauma patients were identified and two studies reported the incidence of HIT in patients with lower leg injuries. The selected papers varied in study design: three randomised controlled trials, three cohort studies and one case report were identified. The methodological quality of the studies varied. In a total population of 1920 patients, HIT was identified in seven patients (0.36%). Pooling of data was impossible due to heterogeneity in study design and populations. No HIT was reported in 826 patients with lower extremity injuries, requiring immobilisation. Only a few studies have reported on the incidence of HIT in trauma patients who receive prophylactic LMWH. In the heterogenous populations of the available studies, the incidence of HIT appears to be very low and comparable to other patient populations. There is hardly any literature on the incidence of HIT in patients with isolated lower leg injuries receiving LMWH, but incidence seems to be very low. The incidence of HIT in trauma patients who receive LMWH thromboprophylaxis appears to be low (0.36%). Incidence of HIT in patients with isolated lower leg injuries receiving LMWH seems very low. Monitoring of platelet count could be considered in hospitalised patients with a high risk for development of HIT. A pre-test scoring system may identify these patients. Copyright © 2011. Published by Elsevier Ltd.

Opportunities for Improvement in Pathology Reporting of Childhood Nonrhabdomyosarcoma Soft Tissue Sarcomas:  A Report From Children's Oncology Group (COG) Study ARST0332.

PubMed

Black, Jennifer O; Coffin, Cheryl M; Parham, David M; Hawkins, Douglas S; Speights, Rose A; Spunt, Sheri L

2016-09-01

Treatment of soft tissue tumors in young patients relies on the diagnostic information conveyed in the pathology report. We examined pathology reports from Children's Oncology Group ARST0332 for inclusion of data elements required in published guidelines. Pathology reports for 551 eligible patients were examined for required data elements defined by the College of American Pathologists, including tissue type, procedure, tumor site, tumor maximum diameter, macroscopic extent of tumor, histologic type, mitotic rate, extent of necrosis, tumor grade, margin status, use of ancillary studies, and pathologic stage. Only 65 (12%) of 551 reports included all required data elements. Of reports containing synoptic templates, 57% were complete. This study reveals significant opportunity to improve the quality of pathology reports in young patients with soft tissue tumors. Use of templates or checklists improves completeness of reports. © American Society for Clinical Pathology, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Use of methylphenidate in the treatment of patients suffering from refractory postural tachycardia syndrome.

PubMed

Kanjwal, Khalil; Saeed, Bilal; Karabin, Beverly; Kanjwal, Yousuf; Grubb, Blair P

2012-01-01

Methylphenidate has been shown to be an effective therapy in patients with refractory neurocardiogenic syncope. However, the role of methylphenidate in patients suffering from postural orthostatic tachycardia (POTS) has not been reported. The study was approved by the institutional review board. A retrospective nonrandomized analysis was preformed on 24 patients evaluated at our autonomic center for POTS from 2003 to 2010. The diagnosis of POTS was based on patient history, physical examination, and response to head up tilt table testing. The mean follow-up period was 9 ± 3 months. The patients were included in the current study if they had a diagnosis of POTS with severe symptoms of orthostatic intolerance and were refractory to the commonly used medications. All of these patients were started on methylphenidate and the response to therapy was considered successful if it provided symptomatic relief. Twenty-four patients (age 28 ± 12, 20 women) met inclusion criterion for this study. The response to treatment was assed subjectively in each patient and was collected in a retrospective fashion from patient charts and physician communications. Four patients reported side effects in the form of nausea and 2 ultimately had to discontinue the treatment. Another 4 patients had a follow-up of less than 6 months. Thus, only 18 patients who received methylphenidate completed the follow-up of 6 months. Out of these 18 patients, 14 (77%) patients reported marked improvement in their symptoms. Nine out of 12 patients who had recurrent episodes of syncope reported no syncope at 6 months of follow-up. Fourteen (77%) patients reported marked improvement in their symptoms of fatigue and presyncope. Four patients continue to have symptoms of orthostatic intolerance and 3 continued to have recurrent episodes of syncope. Methylphenidate may be beneficial in patients with otherwise refractory postural tachycardia syndrome.

Effects of Patient Navigation on Patient Satisfaction Outcomes.

PubMed

Post, Douglas M; McAlearney, Ann Scheck; Young, Gregory S; Krok-Schoen, Jessica L; Plascak, Jesse J; Paskett, Electra D

2015-12-01

Patient navigation (PN) may reduce cancer health disparities. Few studies have investigated the effects of PN on patient-reported satisfaction with care or assessed patients' satisfaction with navigators. The objectives of this study are to test the effects of PN on patient satisfaction with cancer care, assess patients' satisfaction with navigators, and examine the impact of barriers to care on satisfaction for persons with abnormal cancer-related screening tests or symptoms. Study participants included women and men with abnormal breast, cervical, or colorectal cancer screening tests and/or symptoms receiving care at 18 clinics. Navigated (n=416) and non-navigated (n=292) patients completed baseline and end-of-study measures. There was no significant difference between navigated and non-navigated patients in change in patient satisfaction with cancer care from baseline to exit. African-American (p<0.001), single (p=0.03), low income (p<0.01), and uninsured patients (p<0.001) were significantly less likely to report high patient satisfaction at baseline. A significant effect was found for change in satisfaction over time by employment status (p=0.04), with full-time employment showing the most improvement. The interaction between satisfaction with navigators and satisfaction with care over time was marginally significant (p=0.08). Baseline satisfaction was lower for patients who reported a barrier to care (p=0.02). Patients reporting other-focused barriers (p=0.03), including transportation (p=0.02), had significantly lower increases in satisfaction over time. Overall, results suggested that assessing barriers to cancer care and tailoring navigation to barrier type could enhance patients' experiences with health care. PN may have positive effects for healthcare organizations struggling to enhance quality of care.

Attitudes of patients and physicians to insulin therapy in Japan: an analysis of the Global Attitude of Patients and Physicians in Insulin Therapy study.

PubMed

Harashima, Shin-Ichi; Nishimura, Akiko; Inagaki, Nobuya

2017-01-01

The barriers to insulin therapy perceived by Japanese patients with diabetes and their physicians are unclear. We performed sub-analyses of the Global Attitude of Patients and Physicians in Insulin Therapy (GAPP™) study, which included 100 Japanese physicians (of 1250 participating physicians) and 150 Japanese patients (of 1530 patients) who participated in Internet surveys (physicians) or computer-assisted telephone surveys (patients) across eight countries in 2010. We compared the results of Japanese participants with those obtained for the other seven countries. Overall, 44% of the Japanese patients reported omission or non-adherence to insulin, a greater value than that reported in other countries. Japanese physicians reported that non-adherence to insulin was driven by their patients' lifestyles. A greater proportion of patients had a history of hypoglycemia in Japan than in other countries. Most of the physicians (94%) and patients (84%) in Japan reported that the currently available insulin treatment regimens do not fit the diverse lifestyles of patients. Many Japanese patients receiving insulin therapy omit or do not adhere to insulin, possibly because of fear of hypoglycemia, or for lifestyle reasons. Insulin regimens that reduce the risk of hypoglycemia without interfering with patients' lifestyles are needed.

Old-and With Severe Heart Failure: Telemonitoring by Using Digital Pen Technology in Specialized Homecare: System Description, Implementation, and Early Results.

PubMed

Lind, Leili; Carlgren, Gunnar; Karlsson, Daniel

2016-08-01

Telehealth programs for heart failure have been studied using a variety of techniques. Because currently a majority of the elderly are nonusers of computers and Internet, we developed a home telehealth system based on digital pen technology. Fourteen patients (mean age, 84 years [median, 83 years]) with severe heart failure participated in a 13-month pilot study in specialized homecare. Participants communicated patient-reported outcome measures daily using the digital pen and health diary forms, submitting a total of 3 520 reports. The reports generated a total of 632 notifications when reports indicated worsening health. Healthcare professionals reviewed reports frequently, more than 4700 times throughout the study, and acted on the information provided. Patients answered questionnaires and were observed in their home environment when using the system. Results showed that the technology was accepted by participants: patients experienced an improved contact with clinicians; they felt more compliant with healthcare professionals' advice, and they felt more secure and more involved in their own care. Via the system, the healthcare professionals detected heart failure-related deteriorations at an earlier stage, and as a consequence, none of the patients were admitted into hospital care during the study.

Use of a 22-gauge Whitacre needle to reduce the incidence of side effects after lumbar myelography: a prospective randomised study comparing Whitacre and Quincke spinal needles.

PubMed

Pedersen, O N

1996-01-01

In a prospective study lumbar iohexol myelography was performed in 107 consecutive patients, randomised for lumbar puncture with a Quincke or Whitacre spinal needle. All patients answered a questionnaire about possible side effects. Data from 100 patients (58 men, 42 women) were evaluated. In the Quincke group (n = 53), 23 (43%) reported no side effects. In the 30 patients who reported various side effects, post-dural puncture headache (PDPH) occurred in 22 (42%), of whom 9 had mild, 6 moderate and 7 (13%) severe cephalalgia, 18 (34%) reported increased low back pain/sciatica, 5 nausea and 7 dizziness. In the Whitacre group (n = 47), 33 (70%) had no side effects. PDPH was reported by 9 patients (19%), of whom 2 had mild, 6 moderate and only 1 (2%) severe cephalalgia, 4 (9%) reported increased low back pain/sciatica, 5 nausea and 4 dizziness. The conclusion drawn from this study is that lumbar myelography performed with the Whitacre spinal needle reduces postspinal side effects.

Methodological and Reporting Quality of Comparative Studies Evaluating Health-Related Quality of Life of Colorectal Cancer Patients and Controls: A Systematic Review.

PubMed

Wong, Carlos K H; Guo, Vivian Y W; Chen, Jing; Lam, Cindy L K

2016-11-01

Health-related quality of life is an important outcome measure in patients with colorectal cancer. Comparison with normative data has been increasingly undertaken to assess the additional impact of colorectal cancer on health-related quality of life. This review aimed to critically appraise the methodological details and reporting characteristics of comparative studies evaluating differences in health-related quality of life between patients and controls. A systematic search of English-language literature published between January 1985 and May 2014 was conducted through a database search of PubMed, Web of Science, Embase, and Medline. Comparative studies reporting health-related quality-of-life outcomes among patients who have colorectal cancer and controls were selected. Methodological and reporting quality per comparison study was evaluated based on a 11-item methodological checklist proposed by Efficace in 2003 and a set of criteria predetermined by reviewers. Thirty-one comparative studies involving >10,000 patients and >10,000 controls were included. Twenty-three studies (74.2%) originated from European countries, with the largest number from the Netherlands (n = 6). Twenty-eight studies (90.3%) compared the health-related quality of life of patients with normative data published elsewhere, whereas the remaining studies recruited a group of patients who had colorectal cancer and a group of control patients within the same studies. The European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 was the most extensively used instrument (n = 16; 51.6%). Eight studies (25.8%) were classified as "probably robust" for clinical decision making according to the Efficace standard methodological checklist. Our further quality assessment revealed the lack of score differences reported (61.3%), contemporary comparisons (36.7%), statistical significance tested (38.7%), and matching of control group (58.1%), possibly leading to inappropriate control groups for fair comparisons. Meta-analysis of differences between the 2 groups was not available. In general, one-fourth of comparative studies that evaluated health-related quality of life of patients who had colorectal cancer achieved high quality in reporting characteristics and methodological details. Future studies are encouraged to undertake health-related quality-of-life measurement and adhere to a methodological checklist in comparison with controls.

A Qualitative Study of the Change-of-Shift Report at the Patients' Bedside.

PubMed

Grimshaw, John; Hatch, Daniel; Willard, Melissa; Abraham, Sam

Concerns about patient bedside change-of-shift reporting at a community hospital in northern Indiana stimulated the development of this qualitative phenomenological study. A review of the literature revealed a research deficit in acute care nurses' perceptions of bedside reporting in relation to compliance. The research question addressed in this study was, "What are acute care nurses' perceptions of the change-of-shift report at the patients' bedside?" Personal interviews were conducted on 7 medical, surgical, and intensive care unit nurse participants at a community hospital in northern Indiana. Five themes were identified from the collected data, which included the time factor, continuity of care, visualization, and challenges in the communication of discreet information.

Regret in Surgical Decision Making: A Systematic Review of Patient and Physician Perspectives.

PubMed

Wilson, Ana; Ronnekleiv-Kelly, Sean M; Pawlik, Timothy M

2017-06-01

Regret is a powerful motivating factor in medical decision making among patients and surgeons. Regret can be particularly important for surgical decisions, which often carry significant risk and may have uncertain outcomes. We performed a systematic review of the literature focused on patient and physician regret in the surgical setting. A search of the English literature between 1986 and 2016 that examined patient and physician self-reported decisional regret was carried out using the MEDLINE/PubMed and Web of Science databases. Clinical studies performed in patients and physicians participating in elective surgical treatment were included. Of 889 studies identified, 73 patient studies and 6 physician studies met inclusion criteria. Among the 73 patient studies, 57.5% examined patients with a cancer diagnosis, with breast (26.0%) and prostate (28.8%) cancers being most common. Interestingly, self-reported patient regret was relatively uncommon with an average prevalence across studies of 14.4%. Factors most often associated with regret included type of surgery, disease-specific quality of life, and shared decision making. Only 6 studies were identified that focused on physician regret; 2 pertained to surgical decision making. These studies primarily measured regret of omission and commission using hypothetical case scenarios and used the results to develop decision curve analysis tools. Self-reported decisional regret was present in about 1 in 7 surgical patients. Factors associated with regret were both patient- and procedure related. While most studies focused on patient regret, little data exist on how physician regret affects shared decision making.

Sleep Tracking and Exercise in Patients With Type 2 Diabetes Mellitus (Step-D): Pilot Study to Determine Correlations Between Fitbit Data and Patient-Reported Outcomes

PubMed Central

2018-01-01

Background Few studies assessing the correlation between patient-reported outcomes and patient-generated health data from wearable devices exist. Objective The aim of this study was to determine the direction and magnitude of associations between patient-generated health data (from the Fitbit Charge HR) and patient-reported outcomes for sleep patterns and physical activity in patients with type 2 diabetes mellitus (T2DM). Methods This was a pilot study conducted with adults diagnosed with T2DM (n=86). All participants wore a Fitbit Charge HR for 14 consecutive days and completed internet-based surveys at 3 time points: day 1, day 7, and day 14. Patient-generated health data included minutes asleep and number of steps taken. Questionnaires assessed the number of days of exercise and nights of sleep problems per week. Means and SDs were calculated for all data, and Pearson correlations were used to examine associations between patient-reported outcomes and patient-generated health data. All respondents provided informed consent before participating. Results The participants were predominantly middle-aged (mean 54.3, SD 13.3 years), white (80/86, 93%), and female (50/86, 58%). Use of oral T2DM medication correlated with the number of mean steps taken (r=.35, P=.001), whereas being unaware of the glycated hemoglobin level correlated with the number of minutes asleep (r=−.24, P=.04). On the basis of the Fitbit data, participants walked an average of 4955 steps and slept 6.7 hours per day. They self-reported an average of 2.0 days of exercise and 2.3 nights of sleep problems per week. The association between the number of days exercised and steps walked was strong (r=.60, P<.001), whereas the association between the number of troubled sleep nights and minutes asleep was weaker (r=.28, P=.02). Conclusions Fitbit and patient-reported data were positively associated for physical activity as well as sleep, with the former more strongly correlated than the latter. As extensive patient monitoring can guide clinical decisions regarding T2DM therapy, passive, objective data collection through wearables could potentially enhance patient care, resulting in better patient-reported outcomes. PMID:29871856

One-Year Linear Trajectories of Symptoms, Physical Functioning, Cognitive Functioning, Emotional Well-being, and Spiritual Well-being Among Patients Receiving Dialysis.

PubMed

Song, Mi-Kyung; Paul, Sudeshna; Ward, Sandra E; Gilet, Constance A; Hladik, Gerald A

2018-01-25

This study evaluated 1-year linear trajectories of patient-reported dimensions of quality of life among patients receiving dialysis. Longitudinal observational study. 227 patients recruited from 12 dialysis centers. Sociodemographic and clinical characteristics. Participants completed an hour-long interview monthly for 12 months. Each interview included patient-reported outcome measures of overall symptoms (Edmonton Symptom Assessment System), physical functioning (Activities of Daily Living/Instrumental Activities of Daily Living), cognitive functioning (Patient's Assessment of Own Functioning Inventory), emotional well-being (Center for Epidemiologic Studies Depression Scale, State Anxiety Inventory, and Positive and Negative Affect Schedule), and spiritual well-being (Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale). For each dimension, linear and generalized linear mixed-effects models were used. Linear trajectories of the 5 dimensions were jointly modeled as a multivariate outcome over time. Although dimension scores fluctuated greatly from month to month, overall symptoms, cognitive functioning, emotional well-being, and spiritual well-being improved over time. Older compared with younger participants reported higher scores across all dimensions (all P<0.05). Higher comorbidity scores were associated with worse scores in most dimensions (all P<0.01). Nonwhite participants reported better spiritual well-being compared with their white counterparts (P<0.01). Clustering analysis of dimension scores revealed 2 distinctive clusters. Cluster 1 was characterized by better scores than those of cluster 2 in nearly all dimensions at baseline and by gradual improvement over time. Study was conducted in a single region of the United States and included mostly patients with high levels of function across the dimensions of quality of life studied. Multidimensional patient-reported quality of life varies widely from month to month regardless of whether overall trajectories improve or worsen over time. Additional research is needed to identify the best approaches to incorporate patient-reported outcome measures into dialysis care. Copyright © 2017 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Exercise and Self-Reported Limitations in Patients with Inflammatory Bowel Disease.

PubMed

DeFilippis, Ersilia M; Tabani, Saniya; Warren, Ryan U; Christos, Paul J; Bosworth, Brian P; Scherl, Ellen J

2016-01-01

Limited evidence suggests that exercise may have beneficial, anti-inflammatory effects in patients with inflammatory bowel disease (IBD). The purpose of this study was to evaluate the prevalence of exercise in patients with IBD and the limitations they experience secondary to their disease. Two hundred and fifty IBD patients were prospectively enrolled in this study at an academic medical center at the time of their outpatient visits between March and October 2013. Subjects were asked to complete a one-time survey that asks questions about medical and surgical history, exercise frequency and intensity, and the limitations and barriers they experience. Two hundred and twenty-seven patients (148 female patients) completed the survey. Crohn's disease was present in 140 patients (61.5 %), while 87 had ulcerative colitis. Forty-one patients (16.4 %) never exercised, 82 patients (32.8 %) exercised 1-2 times per week, 59 (23.6 %) exercised 3-4 times per week, and 45 (18.0 %) exercised more than four times per week. Of the 186 who regularly exercise, 95 (51 %) reported moderate exercise intensity, 61 (33 %) reported light intensity, and 30 (16 %) reported vigorous intensity. Ninety-nine patients (44 %) reported that their IBD limited their exercise for reasons including fatigue (n = 81), joint pain (n = 37), embarrassment (n = 23), weakness (n = 21), and others. Although they may benefit from exercise, IBD patients experience considerable barriers to regular exercise secondary to the relapsing and remitting nature of IBD. Larger studies are needed to determine the effects of exercise on disease symptomatology and activity.

Using brief self-reports and clinician scales to screen for substance use disorders in psychotic patients.

PubMed

Møller, Turid; Linaker, Olav M

2010-04-01

The aims of this study were to examine evidence for the concurrent validity of two self-report measures and two staff-report measures measuring alcohol and drug problems in seriously mentally ill people and to examine if psychotic patients under-report their alcohol and drug problems in an early intervention clinic. This is a cross-sectional study of 48 patients (26 inpatients and 22 outpatients) from an early intervention clinic for psychosis. To examine the sensitivity and specificity, we compared both the staff-report measures Clinical Alcohol Use Scale (AUS) and Clinical Drug Use Scale (DUS) and the self-report measures Short Michigan Alcohol Screening Test (SMAST-13) and Drug Abuse Screening Test (DAST-20), with the current ICD-10 diagnostic criteria as the gold-standard for alcohol and drug problems. To examine whether the patients under-report their alcohol and drug problems, we also compared the self-report measures SMAST-13 and DAST-20 with the staff-report measures AUS and DUS and ICD-10 consensus substance abuse diagnoses. The results show that the concurrent validity compared with ICD-10 diagnoses was moderate for both the staff-report measures AUS and DUS and for the self-report measures SMAST-13 and DAST-20. Three out of seven patients under-report alcohol problems and one patient out of seven under-report drug use problems according to consensus ICD-10 substance abuse diagnoses. We conclude that the SMAST-13 and DAST-20 in combination with the AUS and DUS, which are easy and quick to perform, are helpful in establishing a common understanding of the patient's alcohol and drug problems in an early intervention clinic.

Diffuse esophageal spasm: has the term lost its relevance? Analysis of 217 cases.

PubMed

Tsuboi, K; Mittal, S K

2011-07-01

Diffuse esophageal spasm (DES) has been reported as a potential cause of dysphagia or chest pain; however, the patho-physiology of DES is unclear. The aim of this study was to examine the manometric correlates of dysphagia and chest pain in this patient population. All patients undergoing manometry at our institution are entered into a prospectively maintained database. After institutional review board approval, the database was queried to identify patients meeting criteria for DES (≥20% simultaneous waves with greater than 30 mm Hg pressure in the distal esophagus). The patient-reported symptoms and manometric data, along with the results of a 24-hour pH study (if done), were extracted for further analysis. Out of 4923 patients, 240 (4.9%) met the manometric criteria for DES. Of these, 217 patients had complete manometry data along with at least one reported symptom. Of the patients with DES, 159 (73.3%) had dysphagia or chest pain as a reported symptom. Patients reporting either dysphagia or chest pain had significantly higher lower esophageal sphincter (LES) pressure than patients without these symptoms (P= 0.007). Significant association was noted between reported dysphagia and percentage of simultaneous waves. Chest pain did not correlate with percent of simultaneous waves, mean amplitude of peristalsis, or 24-hour pH score. The origin of reported chest pain in patients with DES is not clear but may be related to higher LES pressure. Simultaneous waves were associated with reported dysphagia. Using current diagnostic criteria, the term DES has no clinical relevance. © 2010 Copyright the Authors. Journal compilation © 2010, Wiley Periodicals, Inc. and the International Society for Diseases of the Esophagus.

Self-reported Hypoglycaemia in Patients treated with Insulin: A Large Slovenian Retrospectively-prospective Study

PubMed Central

Pongrac Barlovič, Draženka; Zavratnik, Andrej; Skvarča, Aleš; Janša, Karmen; Vukelič, Bojana; Tomažič, Marjeta; Ravnik Oblak, Maja

2017-01-01

Abstract Introduction Hypoglycaemia is the major barrier for glycaemic target achievement in patients treated with insulin. The aim of the present study was to investigate real-world incidence and predictors of hypoglycaemia in insulin-treated patients. Methods More than 300 consecutive patients with type 1 or type 2 diabetes treated with insulin were enrolled during regular out-patient visits from 36 diabetes practices throughout the whole country. They completed a comprehensive questionnaire on hypoglycaemia knowledge, awareness, and incidence in the last month and last six months. In addition, in the prospective part, patients recorded incidence of hypoglycaemic events using a special diary prospectively on a daily basis, through 4 weeks. Results At least one hypoglycaemic event was self-reported in 84.1%, and 56.4% of patients with type 1 and type 2 diabetes, respectively, during the prospective period of 4 weeks. 43.4% and 26.2% of patients with type 1 and type 2 diabetes, respectively, experienced a nocturnal hypoglycaemic event. In the same time-period, severe hypoglycaemia was experienced by 15.9% and 7.1% of patients with type 1 and type 2 diabetes, respectively. Lower glycated haemoglobin was not a significant predictor of hypoglycaemia. Conclusions Rates of self-reported hypoglycaemia in patients treated with insulin in the largest and most comprehensive study in Slovenia so far are higher than reported from randomised control trials, but comparable to data from observational studies. Hypoglycaemia incidence was high even with high glycated haemoglobin values. PMID:29062399

Association between addressing antiseizure drug side effects and patient-reported medication adherence in epilepsy

PubMed Central

Moura, Lidia M V R; Carneiro, Thiago S; Cole, Andrew J; Hsu, John; Vickrey, Barbara G; Hoch, Daniel B

2016-01-01

Background and aim Adherence to treatment is a critical component of epilepsy management. This study examines whether addressing antiepileptic drug (AED) side effects at every visit is associated with increased patient-reported medication adherence. Patients and methods This study identified 243 adults with epilepsy who were seen at two academic outpatient neurology settings and had at least two visits over a 3-year period. Demographic and clinical characteristics were abstracted. Evidence that AED side effects were addressed was measured through 1) phone interview (patient-reported) and 2) medical records abstraction (physician-documented). Medication adherence was assessed using the validated Morisky Medication Adherence Scale-4. Complete adherence was determined as answering “no” to all questions. Results Sixty-two (25%) patients completed the interviews. Participants and nonparticipants were comparable with respect to demographic and clinical characteristics; however, a smaller proportion of participants had a history of drug-resistant epilepsy than nonparticipants (17.7% vs 30.9%, P=0.04). Among the participants, evidence that AED side effects were addressed was present in 48 (77%) medical records and reported by 51 (82%) patients. Twenty-eight (45%) patients reported complete medication adherence. The most common reason for incomplete adherence was missed medication due to forgetfulness (n=31, 91%). There was no association between addressing AED side effects (neither physician-documented nor patient-reported) and complete medication adherence (P=0.22 and 0.20). Discussion and conclusion Among patients with epilepsy, addressing medication side effects at every visit does not appear to increase patient-reported medication adherence. PMID:27826186

Calcium stone lithoptysis in promary ciliary dyskinesia

EPA Science Inventory

BACKGROUND: An association between lithoptysis and primary ciliary dyskinesia (PCD) has not been previously reported. However, reports of lithoptysis from 2 older patients (>60 yr) prompted a study of this association. METHODS: We performed a prospective study of all PCD patients...

Psycho-oncology assessment in Chinese populations: a systematic review of quality of life and psychosocial measures.

PubMed

Hyde, M K; Chambers, S K; Shum, D; Ip, D; Dunn, J

2016-09-01

This systematic review describes psychosocial and quality of life (QOL) measures used in psycho-oncology research with cancer patients and caregivers in China. Medline and PsycINFO databases were searched (1980-2014). Studies reviewed met the following criteria: English language; peer-reviewed; sampled Chinese cancer patients/caregivers; developed, validated or assessed psychometric properties of psychosocial or QOL outcome measures; and reported validation data. The review examined characteristics of measures and participants, translation and cultural adaptation processes and psychometric properties of the measures. Ninety five studies met review criteria. Common characteristics of studies reviewed were they: assessed primarily QOL measures, sampled patients with breast, colorectal, or head and neck cancer, and validated existing measures (>80%) originating in North America or Europe. Few studies reported difficulties translating measures. Regarding psychometric properties of the measures >50% of studies reported subscale reliabilities <α = 0.70, <50% reported test-retest reliability, and <30% reported divergent validity. Few reported sensitivity, specificity or responsiveness. Improved accuracy and transparency of reporting for translation, cultural adaptation and psychometric testing of psychosocial measures is needed. Developing support structures for translating and validating psychosocial measures would enable this and ensure Chinese psycho-oncology clinical practice and research keeps pace with international focus on patient reported outcome measures and data management. © 2015 John Wiley & Sons Ltd.

Can Patient Safety Incident Reports Be Used to Compare Hospital Safety? Results from a Quantitative Analysis of the English National Reporting and Learning System Data.

PubMed

Howell, Ann-Marie; Burns, Elaine M; Bouras, George; Donaldson, Liam J; Athanasiou, Thanos; Darzi, Ara

2015-01-01

The National Reporting and Learning System (NRLS) collects reports about patient safety incidents in England. Government regulators use NRLS data to assess the safety of hospitals. This study aims to examine whether annual hospital incident reporting rates can be used as a surrogate indicator of individual hospital safety. Secondly assesses which hospital characteristics are correlated with high incident reporting rates and whether a high reporting hospital is safer than those lower reporting hospitals. Finally, it assesses which health-care professionals report more incidents of patient harm, which report more near miss incidents and what hospital factors encourage reporting. These findings may suggest methods for increasing the utility of reporting systems. This study used a mix methods approach for assessing NRLS data. The data were investigated using Pareto analysis and regression models to establish which patients are most vulnerable to reported harm. Hospital factors were correlated with institutional reporting rates over one year to examine what factors influenced reporting. Staff survey findings regarding hospital safety culture were correlated with reported rates of incidents causing harm; no harm and death to understand what barriers influence error disclosure. 5,879,954 incident reports were collected from acute hospitals over the decade. 70.3% of incidents produced no harm to the patient and 0.9% were judged by the reporter to have caused severe harm or death. Obstetrics and Gynaecology reported the most no harm events [OR 1.61(95%CI: 1.12 to 2.27), p<0.01] and pharmacy was the hospital location where most near-misses were captured [OR 3.03(95%CI: 2.04 to 4.55), p<0.01]. Clinicians were significantly more likely to report death than other staff [OR 3.04(95%CI: 2.43 to 3.80) p<0.01]. A higher ratio of clinicians to beds correlated with reduced rate of harm reported [RR = -1.78(95%Cl: -3.33 to -0.23), p = 0.03]. Litigation claims per bed were significantly negatively associated with incident reports. Patient satisfaction and mortality outcomes were not significantly associated with reporting rates. Staff survey responses revealed that keeping reports confidential, keeping staff informed about incidents and giving feedback on safety initiatives increased reporting rates [r = 0.26 (p<0.01), r = 0.17 (p = 0.04), r = 0.23 (p = 0.01), r = 0.20 (p = 0.02)]. The NRLS is the largest patient safety reporting system in the world. This study did not demonstrate many hospital characteristics to significantly influence overall reporting rate. There were no association between size of hospital, number of staff, mortality outcomes or patient satisfaction outcomes and incident reporting rate. The study did show that hospitals where staff reported more incidents had reduced litigation claims and when clinician staffing is increased fewer incidents reporting patient harm are reported, whilst near misses remain the same. Certain specialties report more near misses than others, and doctors report more harm incidents than near misses. Staff survey results showed that open environments and reduced fear of punitive response increases incident reporting. We suggest that reporting rates should not be used to assess hospital safety. Different healthcare professionals focus on different types of safety incidents and focusing on these areas whilst creating a responsive, confidential learning environment will increase staff engagement with error disclosure.

Diurnal patterns and relationships between physiological and self-reported stress in patients with epilepsy and psychogenic non-epileptic seizures.

PubMed

Novakova, Barbora; Harris, Peter R; Reuber, Markus

2017-05-01

Patients with epilepsy and those with psychogenic non-epileptic seizures (PNES) experience high levels of stress and stress is one of the most frequently self-identified seizure precipitants. Although stress is a multifaceted phenomenon, few studies have systematically examined its different components in patients with seizures. The aim of this study was therefore to describe diurnal patterns of psychological and physiological measures of stress in patients with epilepsy and patients with PNES, and explore their relationships to each other in order to improve our understanding of the mechanisms underlying stress and seizure occurrence in these patients. A range of stress markers including self-reported stress, salivary cortisol, and heart rate variability (HRV) were explored in adult patients with refractory epilepsy (N=22) and those with PNES (N=23) undergoing three- to five-day video-telemetry. A diurnal pattern was observed in the physiological measures, characterized by higher levels of physiological arousal in the mornings and lower levels at night in both patients with epilepsy and PNES. The physiological measures (cortisol and HRV) were associated with each other in patients with epilepsy; no close relationship was found with self-reported stress in either of the two patient groups. The findings contribute to and expand on previous studies of the patterns of stress in patients with seizures. The results also indicate a discrepancy between patients' physiological responses and their subjective stress perceptions, suggesting that simple self-reports cannot be used as a proxy of physiological arousal in patients with seizures and stress. Stress in these patient groups should be studied using a combination of complementary measures. Copyright © 2017 Elsevier Inc. All rights reserved.

Chronic pain has a strong impact on quality of life in facioscapulohumeral muscular dystrophy

PubMed Central

Wood, Libby; FernáNdez‐Torrón, Roberto; González Coraspe, José Andrés; Turner, Chris; Hilton‐Jones, David; Norwood, Fiona; Willis, Tracey; Parton, Matt; Rogers, Mark; Hammans, Simon; Roberts, Mark; Househam, Elizabeth; Williams, Maggie; Lochmüller, Hanns; Evangelista, Teresinha

2017-01-01

ABSTRACT Introduction Earlier small case series and clinical observations reported on chronic pain playing an important role in facioscapulohumeral dystrophy (FSHD). The aim of this study was to determine the characteristics and impact of pain on quality of life (QoL) in patients with FSHD. Methods We analyzed patient reported outcome measures collected through the U.K. FSHD Patient Registry. Results Of 398 patients, 88.6% reported pain at the time of study. The most frequent locations were shoulders and lower back. A total of 203 participants reported chronic pain, 30.4% of them as severe. The overall disease impact on QoL was significantly higher in patients with early onset and long disease duration. Chronic pain had a negative impact on all Individualised Neuromuscular Quality of Life Questionnaire domains and overall disease score. Discussion Our study shows that pain in FSHD type 1 (FSHD1) is frequent and strongly impacts on QoL, similar to other chronic, painful disorders. Management of pain should be considered when treating FSHD1 patients. Muscle Nerve 57: 380–387, 2018 PMID:29053898

Influence of BMI in nephrolithiasis in an Appalachian pediatric population: A single-center experience.

PubMed

Murphy, Margaret O; Erpelding, Scott G; Chishti, Aftab S; Dugan, Adam; Ziada, Ali; Kiessling, Stefan G

2018-06-07

The prevalence of pediatric nephrolithiasis has increased significantly in the past 20 years. Metabolic abnormalities predisposing adults to nephrolithiasis in obese patients include increased urinary sodium and uric acid excretion as well as low urine pH; however, limited data are available in the pediatric population. The aim was to investigate whether obese pediatric patients presenting with nephrolithiasis have a unique metabolic profile similar to reported findings in obese adults with nephrolithiasis. A retrospective chart review was performed in children aged 1-18 years seen at Kentucky Children's Hospital between 2010 and 2016. Inclusion criteria included all patients with documented stones confirmed by ultrasonography or computed tomography. A total of 111 patient charts were reviewed in the study with a mean age of 11.8 ± 4.2 years. Seventy patients (63%) had a normal BMI and 41 patients (37%) were considered overweight/obese. There was no statistically significant relationship between BMI and stone recurrence. Obese patients had significantly decreased levels of urinary citrate, oxalate, magnesium, and potassium with significant elevations of urinary urea nitrogen, ammonia, and low urine pH compared with normal weight patients (Summary Figure). Several groups have reported on metabolic findings within obese and non-obese pediatric patients. A Turkish study reported increased oxalate excretion and hypocitraturia in obese patients while a Korean study also reported increased rates of hypocitraturia in recurrent stone formers. Similar to these studies, we did find significant differences in citrate within our study population; however, we found significantly lower levels of urinary oxalate in obese patients. The majority of these studies do not report an association with BMI and urine pH although this has been reported in the adult population and our findings support an inverse relationship between body mass index (BMI) and pH. Our group found a higher level of calcium phosphate stones, supporting of Eisner's findings that high BMI is associated with increased supersaturation of calcium phosphate. Limitations of our study include being a single center and retrospective in nature. Our study demonstrates differences in types of stones and urinary metabolites in an obese pediatric population suggestive of different metabolic profiles contributing to stone disease. We report similar association between BMI and urine pH, urinary potassium, and citrate. This study confirmed our primary hypothesis that obese pediatric patients would have a different urinary mineral profile as evidenced by lower levels of citrate and potassium and low urine pH; however, obese patients did not exhibit significantly elevated urinary sodium and uric acid when normalized to weight, as described in the adult population. Our study did not confirm our secondary hypothesis that stone composition would be associated with BMI status or stone recurrence. Copyright © 2018 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

PTSD symptom reports of patients evaluated for the New Mexico Medical Cannabis Program.

PubMed

Greer, George R; Grob, Charles S; Halberstadt, Adam L

2014-01-01

New Mexico was the first state to list post-traumatic stress disorder (PTSD) as a condition for the use of medical cannabis. There are no published studies, other than case reports, of the effects of cannabis on PTSD symptoms. The purpose of the study was to report and statistically analyze psychometric data on PTSD symptoms collected during 80 psychiatric evaluations of patients applying to the New Mexico Medical Cannabis Program from 2009 to 2011. The Clinician Administered Posttraumatic Scale for DSM-IV (CAPS) was administered retrospectively and symptom scores were then collected and compared in a retrospective chart review of the first 80 patients evaluated. Greater than 75% reduction in CAPS symptom scores were reported when patients were using cannabis compared to when they were not. Cannabis is associated with reductions in PTSD symptoms in some patients, and prospective, placebo-controlled study is needed to determine efficacy of cannabis and its constituents in treating PTSD.

A systematic review and development of a classification framework for factors associated with missing patient-reported outcome data.

PubMed

Palmer, Michael J; Mercieca-Bebber, Rebecca; King, Madeleine; Calvert, Melanie; Richardson, Harriet; Brundage, Michael

2018-02-01

Missing patient-reported outcome data can lead to biased results, to loss of power to detect between-treatment differences, and to research waste. Awareness of factors may help researchers reduce missing patient-reported outcome data through study design and trial processes. The aim was to construct a Classification Framework of factors associated with missing patient-reported outcome data in the context of comparative studies. The first step in this process was informed by a systematic review. Two databases (MEDLINE and CINAHL) were searched from inception to March 2015 for English articles. Inclusion criteria were (a) relevant to patient-reported outcomes, (b) discussed missing data or compliance in prospective medical studies, and (c) examined predictors or causes of missing data, including reasons identified in actual trial datasets and reported on cover sheets. Two reviewers independently screened titles and abstracts. Discrepancies were discussed with the research team prior to finalizing the list of eligible papers. In completing the systematic review, four particular challenges to synthesizing the extracted information were identified. To address these challenges, operational principles were established by consensus to guide the development of the Classification Framework. A total of 6027 records were screened. In all, 100 papers were eligible and included in the review. Of these, 57% focused on cancer, 23% did not specify disease, and 20% reported for patients with a variety of non-cancer conditions. In total, 40% of the papers offered a descriptive analysis of possible factors associated with missing data, but some papers used other methods. In total, 663 excerpts of text (units), each describing a factor associated with missing patient-reported outcome data, were extracted verbatim. Redundant units were identified and sequestered. Similar units were grouped, and an iterative process of consensus among the investigators was used to reduce these units to a list of factors that met the guiding principles. The list was organized on a framework, using an iterative consensus-based process. The resultant Classification Framework is a summary of the factors associated with missing patient-reported outcome data described in the literature. It consists of 5 components (instrument, participant, centre, staff, and study) and 46 categories, each with one or more sub-categories or examples. A systematic review of the literature revealed 46 unique categories of factors associated with missing patient-reported outcome data, organized into 5 main component groups. The Classification Framework may assist researchers to improve the design of new randomized clinical trials and to implement procedures to reduce missing patient-reported outcome data. Further research using the Classification Framework to inform quantitative analyses of missing patient-reported outcome data in existing clinical trials and to inform qualitative inquiry of research staff is planned.

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

PubMed

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

2014-04-01

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

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

PubMed Central

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

2014-01-01

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

Factors influencing adverse events reporting within the health care system: the case of artemisinin-based combination treatments in northern Ghana.

PubMed

Chatio, Samuel; Aborigo, Raymond; Adongo, Philip Baba; Anyorigiya, Thomas; Dalinjong, Philip Ayizem; Akweongo, Patricia; Oduro, Abraham

2016-02-27

The use of artemisinin-based combination therapy (ACT) as first-line treatment for uncomplicated malaria was a policy recommended by World Health Organization. In 2004, Ghana changed her first-line anti-malarial drug policy to use ACT. This study examined factors affecting adverse events reporting in northern Ghana after the introduction of ACT. This was a qualitative study based on sixty in-depth interviews with health workers, chemical shop owners and patients with malaria who were given ACT at the health facilities. Purposive sampling method was used to select study participants. The interviews were transcribed, coded into themes using Nvivo 9 software. The thematic analysis framework was used to analyse the data. Study respondents reported body weakness and dizziness as the most frequent side effects they had experienced from the used of ACT. Other side effects they reported were swollen testes, abdominal pain and shivering. These side effects were mostly associated with the use of artesunate-amodiaquine compared to other artemisinin-based combinations. Patients were not provided information about the side effects of the drugs and so did not report when they experienced them. Also long queues at health facilities and unfriendly health worker attitude were the main factors affecting adverse events reporting. Other factors such as wrong use of ACT at home, farming and commercial activities also affected effective adverse events reporting in the study area. Patients' lack of knowledge and health sector drawbacks affected side effect reporting on ACT. Intensive health education on likely side effects of ACT should be provided to patients by health workers. Also, improving health worker attitude toward clients will encourage patients to visit the health facilities when they react negatively to ACT and, subsequently, will improve on adverse events reporting.

The Evolution of Self-Reported Urinary and Sexual Dysfunction over the Last Two Decades: Implications for Comparative Effectiveness Research.

PubMed

Resnick, Matthew J; Barocas, Daniel A; Morgans, Alicia K; Phillips, Sharon E; Koyama, Tatsuki; Albertsen, Peter C; Cooperberg, Matthew R; Goodman, Michael; Greenfield, Sheldon; Hamilton, Ann S; Hoffman, Karen E; Hoffman, Richard M; Kaplan, Sherrie H; McCollum, Dan; Paddock, Lisa E; Stanford, Janet L; Stroup, Antoinette M; Wu, Xiao-Cheng; Penson, David F

2015-06-01

Despite the paramount importance of patient-reported outcomes, little is known about the evolution of patient-reported urinary and sexual function over time. To evaluate differences in pretreatment urinary and sexual function in two population-based cohorts of men with prostate cancer enrolled nearly 20 yr apart. Patients were enrolled in the Prostate Cancer Outcomes Study (PCOS) or the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study, two population-based cohorts that enrolled patients with incident prostate cancer from 1994 to 1995 and from 2011 to 2012, respectively. Participants completed surveys at baseline and various time points thereafter. We performed multivariable logistic and linear regression analysis to investigate differences in pretreatment function between studies. The study comprised 5469 men of whom 2334 (43%) were enrolled in PCOS and 3135 (57%) were enrolled in CEASAR. Self-reported urinary incontinence was higher in CEASAR compared with PCOS (7.7% vs 4.7%; adjusted odds ratio [OR]: 1.83; 95% confidence interval [CI], 1.39-2.43). Similarly, self-reported erectile dysfunction was more common among CEASAR participants (44.7% vs 24.0%) with an adjusted OR of 3.12 (95% CI, 2.68-3.64). Multivariable linear regression models revealed less favorable self-reported baseline function among CEASAR participants in the urinary incontinence and sexual function domains. The study is limited by its observational design and possibility of unmeasured confounding. Reporting of pretreatment urinary incontinence and erectile dysfunction has increased over the past two decades. These findings may reflect sociological changes including heightened media attention and direct-to-consumer marketing, among other potential explanations. Patient reporting of urinary and sexual function has evolved and is likely contingent on continually changing societal norms. Recognizing the evolving nature of patient reporting is essential in efforts to conduct high-quality, impactful comparative effectiveness research. Copyright © 2014 European Association of Urology. All rights reserved.

Two different solicitation methods for obtaining information on adverse events associated with methylphenidate in adolescents: a 12-week multicenter, open-label study.

PubMed

Lee, Moon-Soo; Lee, Soyoung I; Hong, Sungdo D; Kim, Ji-Hoon; Choi, Jeewook; Joung, Yoo-Sook

2013-02-01

We explored two different methods of determining adverse events (AEs) among methylphenidate (MPH)-treated adolescents with attention-deficit/hyperactivity disorder (ADHD). We performed a 12-week open label study of osmotic-release oral system (OROS) MPH in adolescents with ADHD who were recruited from four child and adolescent psychiatric outpatient clinics. The AEs were evaluated via a two-step procedure at weeks 1, 3, 6, and 12. The first step was to ask a general question to subjects and their parents regarding AEs. The second step included an AE evaluation process by the investigators, which was performed using a drug-specific checklist. One-way repeated measures ANOVA were used to compare the number of AEs reported by patients and their parents compared with the number reported by clinicians. This statistical technique was also used to compare the number of AEs reported by various sources (i.e., patients, parents, and clinicians) at weeks 1, 3, 6, and 12. Of the 55 participants (43 males, 12 females) between the ages of 12 and 18 enrolled in this study, 47 participants completed the trial. When the number of AEs reported by patients, parents and clinicians were compared, there were no statistically significant differences. When the numbers of AEs obtained from the three different information sources at each study visit were compared, we noted differences. At week 6, the number of AEs evaluated by clinical investigators was higher than those reported by patients and their parents (p=0.003). Although the results did not reach statistical significance, the number of AEs reported by clinical investigators appeared to be greater than those obtained from patients or parents at weeks 3 and 12. The number of AEs reported by patients and their parents were similar at every visit. There were some differences in the pattern of AEs reported between patients and their parents. Clinicians should supplement the subjective report on AEs from patients or their parents with a more drug-specific checklist to obtain drug side effects more effectively. As there are some differences in the pattern of AEs reported by patients and their parents, it is generally recommended that clinicians obtain information from both parties when possible.

Adherence to Antiretroviral Therapy in Turkey: Results from the ACTHIV-IST Study Group.

PubMed

Yildiz Sevgi, Dilek; Gunduz, Alper; Altuntas Aydin, Ozlem; Mete, Bilgul; Sargin, Fatma; Kumbasar Karaosmanoglu, Hayat; Uzun, Nuray; Yemisen, Mucahit; Dokmetas, Ilyas; Tabak, Fehmi

2017-12-01

Maintaining optimal adherence to antiretroviral therapy (ART) is essential for optimizing the management of HIV infection. The aim of this study is to explore ART adherence rates in Turkey. Included in this study were a total of 263 HIV-infected patients followed up by the ACTHIV-IST (ACTion against HIV in Istanbul) Study Group affiliated with four tertiary hospitals. The study population included patients 18 years of age or older who were on ART for over 12 months. Adherence was assessed by the medication possession ratio (MPR) calculated for each patient using data (a list of all drugs dispensed within the previous year for that patient) obtained from pharmacy medication records. In addition, patients completed a self-report questionnaire addressing missed doses and the AIDS Clinical Trials Group (ACTG) adherence questionnaire. The study was reviewed and approved by the Ethics Committee of Cerrahpasa Medical Faculty. Patient ages ranged from 19 to 71 years. Two hundred and thirty-one patients were male (88%). Two hundred and twenty-four patients (85%) had optimal adherence (MPR ≥95%). During the course of ART, 236 patients (90%) reported no missed doses in the past 4 days of their treatment, whereas 206 patients (78%) reported no missed doses in the past month. Simply forgetting was the most common reason for nonadherence. MPR was associated with virologic rebound. Major factors affecting adherence were being female, taking antituberculosis drugs, having an opportunistic infection, being able to take all or most of the medication as directed, and being aware of the need to take medication exactly as instructed to prevent the development of drug resistance. Adherence to ART measured by MPR and self-report surveys is relatively high in Turkey when compared with other countries, which probably led to high ART success rates.

Correlation of treatment-emergent adverse events and clinical response to endocrine therapy in early breast cancer: a retrospective analysis of the German cohort of TEAM.

PubMed

Hadji, P; Kieback, D G; Tams, J; Hasenburg, A; Ziller, M

2012-10-01

Previous studies have suggested a correlation between the occurrence of vasomotor or joint symptoms during tamoxifen or aromatase inhibitor treatment and improved clinical response. A retrospective analysis of the German cohort of the Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial was carried out to assess disease-free survival (DFS) and overall survival (OS) in patients with and without arthralgia/myalgia and/or menopausal symptoms during adjuvant endocrine treatment. A total of 1502 patients were included; 739 patients received tamoxifen followed by exemestane and 763 received exemestane. Patients reporting arthralgia/myalgia and patients reporting menopausal symptoms during endocrine treatment had significantly longer OS and DFS than those not reporting these events. The effect on OS was irrespective of treatment. DFS was significantly improved in exemestane-treated patients reporting arthralgia/myalgia or those reporting menopausal symptoms versus those not reporting these events. This effect on DFS was not observed in patients receiving sequential treatment. A combined analysis of patients reporting either menopausal symptoms or arthralgia/myalgia showed that OS and DFS were significantly improved in patients reporting one of these symptoms versus those not reporting either symptom. The occurrence of arthralgia/myalgia or menopausal symptoms during endocrine treatment is associated with significantly improved OS.

[Clinical and histopathological features of myositis associated with anti-mitochondrial antibodies].

PubMed

Shimizu, Jun

2013-01-01

Anti-mitochondrial antibodies (AMA) are known to be characteristic markers of primary biliary cirrhosis (PBC). The association of PBC with myositis has been reported mainly as case reports, and comprehensive studies of the clinical and histopathological features of patients with myositis and AMAs or PBC have not been conducted thus far. We retrospectively reviewed 212 patients with inflammatory myopathies in our laboratory and found 24 patients with AMA-positive myositis (11%) (seven patients with PBC and 17 patients without PBC). The analysis of clinical and histopathological features revealed that myositis associated with AMAs frequently include patients with a clinically chronic disease course, muscle atrophy, cardiopulmonary involvement and granulomatous inflammation, regardless of the presence or absence of PBC. We also reviewed and analyzed the clinical features of previously reported patients. The analysis of 75 patients, which have been described in previous case reports including the ones of meeting abstracts, also showed the similar results about clinical features of myositis associated with AMAs and supported our findings. Our study suggests that myositis associated with AMAs form a characteristic subgroup.

Documentation of pain care processes does not accurately reflect pain management delivered in primary care.

PubMed

Krebs, Erin E; Bair, Matthew J; Carey, Timothy S; Weinberger, Morris

2010-03-01

Researchers and quality improvement advocates sometimes use review of chart-documented pain care processes to assess the quality of pain management. Studies have found that primary care providers frequently fail to document pain assessment and management. To assess documentation of pain care processes in an academic primary care clinic and evaluate the validity of this documentation as a measure of pain care delivered. Prospective observational study. 237 adult patients at a university-affiliated internal medicine clinic who reported any pain in the last week. Immediately after a visit, we asked patients to report the pain treatment they received. Patients completed the Brief Pain Inventory (BPI) to assess pain severity at baseline and 1 month later. We extracted documentation of pain care processes from the medical record and used kappa statistics to assess agreement between documentation and patient report of pain treatment. Using multivariable linear regression, we modeled whether documented or patient-reported pain care predicted change in pain at 1 month. Participants' mean age was 53.7 years, 66% were female, and 74% had chronic pain. Physicians documented pain assessment for 83% of visits. Patients reported receiving pain treatment more often (67%) than was documented by physicians (54%). Agreement between documentation and patient report was moderate for receiving a new pain medication (k = 0.50) and slight for receiving pain management advice (k = 0.13). In multivariable models, documentation of new pain treatment was not associated with change in pain (p = 0.134). In contrast, patient-reported receipt of new pain treatment predicted pain improvement (p = 0.005). Chart documentation underestimated pain care delivered, compared with patient report. Documented pain care processes had no relationship with pain outcomes at 1 month, but patient report of receiving care predicted clinically significant improvement. Chart review measures may not accurately reflect the pain management patients receive in primary care.

Feasibility of Patient Reporting of Symptomatic Adverse Events via the PRO-CTCAE in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial

PubMed Central

Basch, Ethan; Pugh, Stephanie L; Dueck, Amylou C; Mitchell, Sandra A; Berk, Lawrence; Fogh, Shannon; Rogak, Lauren J; Gatewood, Marcha; Reeve, Bryce B; Mendoza, Tito R; O’Mara, Ann; Denicoff, Andrea; Minasian, Lori; Bennett, Antonia V; Setser, Ann; Schrag, Deborah; Roof, Kevin; Moore, Joan K; Gergel, Thomas; Stephans, Kevin; Rimner, Andreas; DeNittis, Albert; Bruner, Deborah Watkins

2017-01-01

Purpose To assess the feasibility of measuring symptomatic adverse events (AEs) in a multicenter clinical trial using the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Methods and Materials Patients enrolled in Trial XXXX (XXXX) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly x4 during treatment; 12-weeks post-treatment). Reporting was conducted via wireless tablet computers in clinic waiting areas. Compliance was defined as the proportion of visits when an expected PRO-CTCAE assessment was completed. Results Among 226 study sites participating in Trial XXXX, 100% completed 35-minute PRO-CTCAE training for clinical research associates (CRAs); 80 sites enrolled patients of which 34 (43%) required tablet computers to be provided. All 152 patients in Trial XXXX agreed to self-report using the PRO-CTCAE (median age 66; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range 30–240), and median time for CRAs to teach a patient to self-report was 10 minutes (range 2–60). Compliance was high, particularly during active treatment when patients self-reported at 86% of expected time points, although compliance was lower post-treatment (72%). Common reasons for non-compliance were institutional errors such as forgetting to provide computers to participants; patients missing clinic visits; internet connectivity; and patients feeling “too sick”. Conclusions Most patients enrolled in a multicenter chemoradiotherapy trial were willing and able to self-report symptomatic adverse events at visits using tablet computers. Minimal effort was required by local site staff to support this system. The observed causes of missing data may be obviated by allowing patients to self-report electronically between-visits, and by employing central compliance monitoring. These approaches are being incorporated into ongoing studies. PMID:28463161

Design and methodology of SNAP-1: a Sprint National Anaesthesia Project to measure patient reported outcome after anaesthesia.

PubMed

Moonesinghe, Suneetha Ramani; Walker, Eleanor Mary Kate; Bell, Madeline

2015-01-01

Patient satisfaction is an important metric of health-care quality. Accidental awareness under general anaesthesia (AAGA) is a serious complication of anaesthesia care which may go unrecognised in the immediate perioperative period but leads to long-term psychological harm for affected patients. The SNAP-1 study aimed to measure patient satisfaction with anaesthesia care and the incidence of AAGA, reported on direct questioning within 24 h of surgery, in a large multicentre cohort. A secondary aim of SNAP-1 was to test the effectiveness of a new network of Quality Audit and Research Coordinators in NHS anaesthetic departments, to achieve widespread study participation and high patient recruitment rates. This manuscript describes the study methodology. SNAP-1 was a prospective observational cohort study. The study protocol was approved by the National Research Ethics Service. All UK NHS hospitals with anaesthetic departments were invited to participate. Adult patients undergoing any type of non-obstetric surgery were recruited in participating hospitals on 13th and 14th May 2014. Demographic data were collected by anaesthetists providing perioperative care. Patients were then approached within 24 h of surgery to complete two questionnaires-the Bauer patient satisfaction questionnaire (to measure patient reported outcome) and the modified Brice questionnaire (to detect possible accidental awareness). Completion of postoperative questionnaires was taken as evidence of implied consent. Results were recorded on a standard patient case report form, and local investigators entered anonymised data into an electronic database for later analysis by the core research team. Preliminary analyses indicate that over 15,000 patients were recruited across the UK, making SNAP-1 the largest NIHR portfolio-adopted study in anaesthesia to date. Both descriptive and analytic epidemiological analyses will be used to answer specific questions about the patient perception of anaesthesia care overall and in surgical sub-specialties and to determine the incidence of AAGA. The SNAP-1 study recruited a large number of UK hospitals and thousands of perioperative patients using newly established networks in the UK anaesthetic profession. The results will provide benchmarking information to aid interpretation of patient satisfaction data and also determine the incidence of AAGA reported on a single postoperative visit.

Moving the Needle: Simulation's Impact on Patient Outcomes.

PubMed

Cox, Tiffany; Seymour, Neal; Stefanidis, Dimitrios

2015-08-01

This review investigates the available literature that addresses the impact simulator training has on patient outcomes. The authors conducted a comprehensive literature search of studies reporting outcomes of simulation training and categorized studies based on the Kirkpatrick model of training evaluation. Kirkpatrick level 4 studies reporting patient outcomes were identified and included in this review. Existing evidence is promising, demonstrating patient benefits as a result of simulation training for central line placement, obstetric emergencies, cataract surgery, laparoscopic inguinal hernia repair, and team training. Copyright © 2015 Elsevier Inc. All rights reserved.

Clinical characteristics of the asthma-COPD overlap syndrome--a systematic review.

PubMed

Nielsen, Mia; Bårnes, Camilla Boslev; Ulrik, Charlotte Suppli

2015-01-01

In recent years, the so-called asthma-chronic obstructive pulmonary disease (COPD) overlap syndrome (ACOS) has received much attention, not least because elderly individuals may present characteristics suggesting a diagnosis of both asthma and COPD. At present, ACOS is described clinically as persistent airflow limitation combined with features of both asthma and COPD. The aim of this paper is, therefore, to review the currently available literature focusing on symptoms and clinical characteristics of patients regarded as having ACOS. Based on the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines, a systematic literature review was performed. A total of 11 studies met the inclusion criteria for the present review. All studies dealing with dyspnea (self-reported or assessed by the Medical Research Council dyspnea scale) reported more dyspnea among patients classified as having ACOS compared to the COPD and asthma groups. In line with this, ACOS patients have more concomitant wheezing and seem to have more cough and sputum production. Compared to COPD-only patients, the ACOS patients were found to have lower FEV1% predicted and FEV1/FVC ratio in spite of lower mean life-time tobacco exposure. Furthermore, studies have revealed that ACOS patients seem to have not only more frequent but also more severe exacerbations. Comorbidity, not least diabetes, has also been reported in a few studies, with a higher prevalence among ACOS patients. However, it should be acknowledged that only a limited number of studies have addressed the various comorbidities in patients with ACOS. The available studies indicate that ACOS patients may have more symptoms and a higher exacerbation rate than patients with asthma and COPD only, and by that, probably a higher overall respiratory-related morbidity. Similar to patients with COPD, ACOS patients seem to have a high occurrence of comorbidity, including diabetes. Further research into the ACOS, not least from well-defined prospective studies, is clearly needed.

MyPectus: First-in-human pilot study of remote compliance monitoring of teens using dynamic compression bracing to correct pectus carinatum.

PubMed

Harrison, Brittany; Stern, Lily; Chung, Philip; Etemadi, Mozziyar; Kwiat, Dillon; Roy, Shuvo; Harrison, Michael R; Martinez-Ferro, Marcelo

2016-04-01

Patient compliance is a crucial determinant of outcomes in treatments involving medical braces, such as dynamic compression therapy for pectus carinatum (PC). We performed a pilot study to assess a novel, wireless, real-time monitoring system (MyPectus) to address noncompliance. Eight patients (10-16years old) with moderately severe PC deformities underwent bracing. Each patient received a data logger device inserted in the compression brace to sense temperature and pressure. The data were transmitted via Bluetooth 4.0 to an iOS smartphone app, then synced to cloud-based storage, and presented to the clinician on a web-based dashboard. Patients received points for brace usage on the app throughout the 4-week study, and completed a survey to capture patient-reported usage patterns. In all 8 patients, the data logger sensed and recorded data, which connected through all MyPectus system components. There were occasional lapses in data collection because of technical difficulties, such as limited storage capacity. Patients reported positive feedback regarding points. The components of the MyPectus system recorded, stored, and provided data to patients and clinicians. The MyPectus system will inform clinicians about issues related to noncompliance: discrepancy between patient-reported and sensor-reported data regarding brace usage; real-time, actionable information; and patient motivation. Copyright © 2015 Elsevier Inc. All rights reserved.

Information on new drugs at market entry: retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry reports.

PubMed

Köhler, Michael; Haag, Susanne; Biester, Katharina; Brockhaus, Anne Catharina; McGauran, Natalie; Grouven, Ulrich; Kölsch, Heike; Seay, Ulrike; Hörn, Helmut; Moritz, Gregor; Staeck, Kerstin; Wieseler, Beate

2015-02-26

When a new drug becomes available, patients and doctors require information on its benefits and harms. In 2011, Germany introduced the early benefit assessment of new drugs through the act on the reform of the market for medicinal products (AMNOG). At market entry, the pharmaceutical company responsible must submit a standardised dossier containing all available evidence of the drug's added benefit over an appropriate comparator treatment. The added benefit is mainly determined using patient relevant outcomes. The "dossier assessment" is generally performed by the Institute for Quality and Efficiency in Health Care (IQWiG) and then published online. It contains all relevant study information, including data from unpublished clinical study reports contained in the dossiers. The dossier assessment refers to the patient population for which the new drug is approved according to the summary of product characteristics. This patient population may comprise either the total populations investigated in the studies submitted to regulatory authorities in the drug approval process, or the specific subpopulations defined in the summary of product characteristics ("approved subpopulations"). To determine the information gain from AMNOG documents compared with non-AMNOG documents for methods and results of studies available at market entry of new drugs. AMNOG documents comprise dossier assessments done by IQWiG and publicly available modules of company dossiers; non-AMNOG documents comprise conventional, publicly available sources-that is, European public assessment reports, journal publications, and registry reports. The analysis focused on the approved patient populations. Retrospective analysis. All dossier assessments conducted by IQWiG between 1 January 2011 and 28 February 2013 in which the dossiers contained suitable studies allowing for a full early benefit assessment. We also considered all European public assessment reports, journal publications, and registry reports referring to these studies and included in the dossiers. We assessed reporting quality for each study and each available document for eight methods and 11 results items (three baseline characteristics and eight patient relevant outcomes), and dichotomised them as "completely reported" or "incompletely reported (including items not reported at all)." For each document type we calculated the proportion of items with complete reporting for methods and results, for each item and overall, and compared the findings.Results 15 out of 27 dossiers were eligible for inclusion and contained 22 studies. The 15 dossier assessments contained 28 individual assessments of 15 total study populations and 13 approved subpopulations. European public assessment reports were available for all drugs. Journal publications were available for 14 out of 15 drugs and 21 out of 22 studies. A registry report in ClinicalTrials.gov was available for all drugs and studies; however, only 11 contained results. In the analysis of total study populations, the AMNOG documents reached the highest grade of completeness, with about 90% of methods and results items completely reported. In non-AMNOG documents, the rate was 75% for methods and 52% for results items; journal publications achieved the best rates, followed by European public assessment reports and registry reports. The analysis of approved subpopulations showed poorer complete reporting of results items, particularly in non-AMNOG documents (non-AMNOG versus AMNOG: 11% v 71% for overall results items and 5% v 70% for patient relevant outcomes). The main limitation of our analysis is the small sample size. Conventional, publicly available sources provide insufficient information on new drugs, especially on patient relevant outcomes in approved subpopulations. This type of information is largely available in AMNOG documents, albeit only partly in English. The AMNOG approach could be used internationally to develop a comprehensive publication model for clinical studies and thus represents a key open access measure. © Köhler et al 2015.

Expert Review of Cervical Cytology: Does it Affect Patient Care?

PubMed

Mark, Jaron; Morrell, Kayla; Eng, Kevin; Alfiero, Alexandra; Frederick, Peter J

2018-04-01

The aim of the study was to evaluate whether expert review of outside cervical cytology affects patient care. A retrospective study was conducted of 424 new patient referrals for cervical dysplasia between 2004 and 2016 at Roswell Park Cancer Institute. Records were analyzed for outside cervical cytology reports and compared with expert cervical cytology review. Differences between expert review and outside reports were documented. Charts with a difference were then assessed for additional evaluation and procedures performed. We specifically analyzed the data for cytology being upgraded or downgraded after expert review. Two hundred forty-six patient charts were eligible for this study. We identified 165 patients with congruent pathology reports. Of the 81 different reports, 41 led to significant pathologic differences. Twenty-four reports with different pathology were low-grade squamous intraepithelial lesions (LSIL) upgraded to high-grade squamous intraepithelial lesions (HSIL). Six were HSIL downgraded to LSIL, 4 LSIL downgraded to negative, 3 AGC upgraded to HSIL, 2 AGC upgraded to cancer, 1 each for HSIL downgraded to negative, and AGC downgraded to negative. Of the 24 patients whose cytology changed from low grade to high grade, 17 underwent an excisional procedure and 1 had a laser ablative procedure. Cervical intraepithelial neoplasia 2 or 3 was found in 11 specimens. Cervical intraepithelial neoplasia 1 was found in 4 of excisional specimens and no dysplasia found in 2. Expert review of cervical cytology significantly impacts patient management at a tertiary referral center, resulting in both upgrading and downgrading of community cytology reports.

Quality of life among adult patients with neurofibromatosis 1, neurofibromatosis 2 and schwannomatosis: a systematic review of the literature.

PubMed

Vranceanu, Ana-Maria; Merker, Vanessa L; Park, Elyse; Plotkin, Scott R

2013-09-01

The aim of this study was to review the literature on quality of life among adult patients with neurofibromatosis 1, neurofibromatosis 2 and schwannomatosis, and to identify the specific aspects of quality of life that were studied and reported in this population. We also set out to report predictors of quality of life. Published research reports were included if they described quality of life in this population and met methodological quality according to a list of predefined criteria. Eight studies (7 in NF1, 1 in NF2, 0 in schwannomatosis), conducted between 2001 and 2013, met inclusion criteria. The methodological quality of the eight studies was mostly high according to ratings by predefined criteria. Most studies reported that patients with NF experience decreased quality of life when compared to the general population. Visibility and disease severity were strong predictors of skin-specific quality of life in NF1 patients. However, the majority of findings regarding predictors of quality of life were weak or inconclusive. Given the decreased quality of life in NF patients, it is important to examine more comprehensively the psychosocial factors in this population, especially in patients with NF2 and schwannomatosis. Mind body interventions that address these domains may provide comprehensive and efficacious long term treatment.

Unusual ulcerative keratitis caused by Prototheca wickerhamii in a diabetic patient.

PubMed

Narayanan, Niveditha; Vaidehi, D; Dhanurekha, L; Therese, K Lily; Rajagopal, Rama; Natarajan, Radhika; Lakshmipathy, Meena

2018-02-01

The purpose of the study was to report a case of ulcerative keratitis caused by an unusual algae Prototheca wickerhamii in a diabetic patient. This study design was a case report. A 46-year-old male, who was a known diabetic for 3 years, had an injury to the left cornea with the sparks of fire from wielding at work that developed into an ulcerative keratitis over a period of next 3 months as the patient was not on any medication. Corneal scraping culture report and Vitek 2 system investigation result confirmed it to be a P. wickerhamii infection. The patient was started on intensive topical 1% voriconazole and 5% natamycin for 1 month and with no improvement subsequently underwent penetrating keratoplasty. No recurrence of infection postoperatively was noted. This opportunistic algae rarely known to cause human eye infections is so far reported in either patients with severe systemic immunosuppression causing posterior segment eye involvement or as postcorneal surgery infections. We report an ulcerative keratitis by P. wickerhamii in a diabetic patient post corneal trauma with no prior ocular surgery.

Unusual ulcerative keratitis caused by Prototheca wickerhamii in a diabetic patient

PubMed Central

Narayanan, Niveditha; Vaidehi, D; Dhanurekha, L; Therese, K Lily; Rajagopal, Rama; Natarajan, Radhika; Lakshmipathy, Meena

2018-01-01

The purpose of the study was to report a case of ulcerative keratitis caused by an unusual algae Prototheca wickerhamii in a diabetic patient. This study design was a case report. A 46-year-old male, who was a known diabetic for 3 years, had an injury to the left cornea with the sparks of fire from wielding at work that developed into an ulcerative keratitis over a period of next 3 months as the patient was not on any medication. Corneal scraping culture report and Vitek 2 system investigation result confirmed it to be a P. wickerhamii infection. The patient was started on intensive topical 1% voriconazole and 5% natamycin for 1 month and with no improvement subsequently underwent penetrating keratoplasty. No recurrence of infection postoperatively was noted. This opportunistic algae rarely known to cause human eye infections is so far reported in either patients with severe systemic immunosuppression causing posterior segment eye involvement or as postcorneal surgery infections. We report an ulcerative keratitis by P. wickerhamii in a diabetic patient post corneal trauma with no prior ocular surgery. PMID:29380790

Patient-reported outcomes of azelaic acid foam 15% for patients with papulopustular rosacea: secondary efficacy results from a randomized, controlled, double-blind, phase 3 trial.

PubMed

Tyring, Stephen; Solomon, James A; Staedtler, Gerald; Lott, Jason P; Nkulikiyinka, Richard; Shakery, Kaweh

2016-10-01

Patient-reported treatment outcomes are important for evaluating the impact of drug therapies on patient experience. A randomized, double-blind, vehicle-controlled, parallel-group, multicenter, phase 3 study was conducted in 961 participants to assess patient perception of efficacy, utility, and effect on quality of life (QOL) of an azelaic acid (AzA) 15% foam formulation for the treatment of papulopustular rosacea (PPR). Secondary end points included patient-reported global assessment of treatment response, global assessment of tolerability, and opinion on cosmetic acceptability and practicability of product use. Quality of life assessments included the Dermatology Quality of Life Index (DLQI) and Rosacea Quality of Life Index (RosaQOL). Self-reported global assessment of treatment response favored AzA foam over vehicle foam (P<.001), with 57.2% of the AzA foam group reporting excellent or good improvement versus 44.7% in the vehicle foam group. Tolerability was rated excellent or good in 67.8% of the AzA foam group versus 78.2% of the vehicle foam group. Mean overall DLQI scores at end of treatment (EoT) were improved (P=.018) in favor of the AzA foam group compared with the vehicle foam group. Both treatment groups showed improvements in RosaQOL. Treatment with AzA foam was associated with improved QOL and meaningful reductions in the patient-perceived burden of PPR, which correlates with earlier reported primary end points of this study and supports the inclusion of patient perspectives in studies evaluating the effects of topical dermatologic treatments.

Abdominal pain localization is associated with non-diarrheic Rome III functional gastrointestinal disorders.

PubMed

Bouchoucha, M; Fysekidis, M; Devroede, G; Raynaud, J-J; Bejou, B; Benamouzig, R

2013-08-01

Abdominal pain is common in patients with functional bowel disorders (FBDs). The aim of this study was to characterize the predominant sites of abdominal pain associated with FBD subtypes, as defined by the Rome III criteria. A total of 584 consecutive patients attending FBD consultations in a tertiary center participated in the study. Stool form, abdominal pain location (nine abdominal segments), and pain intensity (10-point Likert scale) during the previous week were recorded. Logistic regression analysis was used to characterize the association of abdominal pain sites with specific FBD subtypes. FBDs were associated with predominant pain sites. Irritable bowel syndrome (IBS) with constipation was associated with pain in the left flank and patients were less likely to report pain in the right hypochondrium. Patients with functional constipation reported pain in the right hypochondrium and were less likely to report pain in the left flank and left iliac site. IBS with alternating constipation and diarrhea was associated with pain in the right flank, and unsubtyped IBS with pain in the hypogastrium Patients with functional abdominal pain syndrome reported the lower right flank as predominant pain site. Patients with unspecified FBDs were least likely to report pain in the hypogastrium. Patients with functional diarrhea, IBS with diarrhea, or functional bloating did not report specific pain sites. The results from this study provide the basis for developing new criteria allowing for the identification of homogeneous groups of patients with non-diarrheic FBDs based on characteristic sites of pain. © 2013 John Wiley & Sons Ltd.

The Dialysis Outcomes and Practice Patterns Study (DOPPS) in Turkey.

PubMed

Ecder, Tevfik; Utas, Cengiz; Ates, Kenan; Bieber, Brian; Robinson, Bruce M; Pisoni, Ronald L; Süleymanlar, Gültekin

2017-07-01

Turkey has one of the largest treated end-stage renal disease (ESRD) patient populations in Europe (N = 66,711). In 2013, the international Dialysis Outcomes and Practice Patterns Study (DOPPS), a prospective study of hemodialysis (HD) practices and outcomes, initiated data collection in Turkey. Here we provide comparisons of HD patients in DOPPS-Turkey with other international regions and with patients in the Registry of Turkish Nephrology, Dialysis and Transplantation. DOPPS-Turkey study sites were randomly selected from all Turkish HD units treating ≥25 in-center chronic HD patients. Detailed patient- and facility-level data were collected for 20-30 randomly selected prevalent HD patients per facility. Demographic and comorbidity profiles for DOPPS-Turkey patients were similar to HD patients overall in the 2013 Turkish Registry Report. In Turkey: diabetes was the most common ESRD cause (37%); arteriovenous fistula use was 83%; mean single pool Kt/V was 1.61. Compared with other international regions, Turkey had the highest mean hemoglobin (11.5 g/dL), ferritin (771 ng/mL), and interdialytic weight gain (3.28%), while Turkey had the lowest mean systolic blood pressure (127 mmHg) and erythropoiesis stimulating agent prescription (57%). Turkish patients also reported the highest depression scores. In this first DOPPS-Turkey report, the DOPPS sample agrees well with national Turkish Registry data. Treatment and laboratory data, and patient-reported outcomes, demonstrate similarities and previously unrecognized contrasts to DOPPS findings in Europe, Japan, and North America. Long-term follow-up of these patients will describe how these differences relate to clinical outcomes within Turkey. © 2016 International Society for Hemodialysis.

Predictors of ICU patients' pain management satisfaction: A descriptive cross-sectional survey.

PubMed

Darawad, Muhammad W; Al-Hussami, Mahmoud; Saleh, Ali M; Al-Sutari, Manal; Mustafa, Waddah Mohammad

2015-08-01

(1) To assess Jordanian ICU patients' pain characteristics (intensity and interference) and levels of pain management satisfaction; and (2) to determine potential predictors of pain management satisfaction among ICU patients. A descriptive cross-sectional design was utilised using the American Pain Society-Patient Outcome Questionnaire to survey 139 Jordanian ICU patients from different health care sectors in Jordan. High levels of pain and pain interferences were reported by participants, which were higher than those reported by previous studies in other countries. However, participants were relatively satisfied with pain management approaches. Also, the results showed a predictive model of three potential predictors, which accounted for 36% of the variance in participants' satisfaction with pain management (adjusted R(2)=0.36, F=12.14, df=7129, p<0.005). The strongest predictor to participants' satisfaction with pain management was time needed to get analgesia (beta=-0.480, p<0.001), followed by average pain interference (beta=0.218, p=0.02), and being told about importance of reporting pain (beta=0.198, p=0.006). Jordanian ICU patients reported high pain levels, which supports the need for applying a caring attitude in managing patients' pain reports. Also, such a study is among the first pain management studies in Jordan aiming at setting the stage for future research studies. Finally, results can be included in planning pain management strategies and protocols within hospitals. Copyright © 2014 Australian College of Critical Care Nurses Ltd. Published by Elsevier Ltd. All rights reserved.

Randomized Controlled Trial Investigating the Role of Exercise in the Workplace to Improve Work Ability, Performance, and Patient-Reported Symptoms Among Older Workers With Osteoarthritis.

PubMed

Chopp-Hurley, Jaclyn N; Brenneman, Elora C; Wiebenga, Emily G; Bulbrook, Brittany; Keir, Peter J; Maly, Monica R

2017-06-01

The aim of this study was to evaluate the effectiveness of a 12-week workplace exercise program on work ability, performance, and patient-reported symptoms in older university employees with knee and/or hip osteoarthritis. Twenty-four participants with clinical hip and/or knee osteoarthritis were randomized to exercise or no exercise. At baseline and follow-up, several work (work ability, resilience), patient-reported (pain, physical function, depressive symptoms, self-efficacy), and performance outcomes (hip and knee strength, mobility performance) were measured. Significant improvements in work ability (P < 0.049) and patient-reported outcomes (pain, function, depressive symptoms) existed in the exercise group. No improvements were demonstrated in the no exercise group. Exercise in the workplace improved work ability and patient-reported symptoms in older workers with osteoarthritis. The benefits of workplace exercise programs should be studied in a larger sample in which attention is given to improving exercise adherence.

Measure Once, Cut Twice – Adding Patient-Reported Outcome Measures to the Electronic Health Record for Comparative Effectiveness Research

PubMed Central

Wu, Albert W.; Kharrazi, Hadi; Boulware, L. Ebony; Snyder, Claire F.

2013-01-01

Objective This paper presents the current state of patient-reported outcome measures, and explains new opportunities for leveraging the recent adoption of electronic health records to expand the application of patient-reported outcomes in both clinical care and comparative effectiveness research. Study Design and Setting Historic developments of patient-reported outcome, electronic health record, and comparative effectiveness research are analyzed in two dimensions: patient-centeredness and digitization. We pose the question: “What needs to be standardized around the collection of patient-reported outcomes in electronic health records for comparative effectiveness research?” Results We identified three converging trends: the progression of patient-reported outcomes toward greater patient centeredness and electronic adaptation; the evolution of electronic health records into personalized and fully digitized solutions; the shift toward patient-oriented comparative effectiveness research. Related to this convergence, we propose an architecture for patient-reported outcome standardization that could serve as a first step toward a more comprehensive integration of patient-reported outcomes with electronic health record for both practice and research. Conclusion The science of patient-reported outcome measurement has matured sufficiently to be integrated routinely into electronic health records and other e-health solutions to collect data on an ongoing basis for clinical care and comparative effectiveness research. Further efforts and ideally coordinated efforts from various stakeholders are needed to refine the details of the proposed framework for standardization. PMID:23849145

Encouraging post-stroke patients to be active seems possible: results of an intervention study with knowledge brokers.

PubMed

Willems, Mia; Schröder, Carin; van der Weijden, Trudy; Post, Marcel W; Visser-Meily, Anne M

2016-08-01

Although physical activity and exercise for stroke patients is highly recommended for fast recovery, patients in hospitals and rehabilitation centres are insufficiently encouraged to be physically active. In this study, we investigated the impact of knowledge brokers (KBs), enterprising nurses and therapists, on health professionals' (HP) performance to encourage stroke inpatients to be physically active. This multicenter intervention study used a pre-post test design. Two or three KBs were trained in each stroke unit of 12 hospitals and 10 rehabilitation centres in The Netherlands. Questionnaires were completed by patients and HPs before and after the KB-intervention. The primary outcome was encouragement given by HPs to their patients to be physically active, as reported by patients and HPs. After the KB-intervention, many more patients (48%; N=217) reported at least some encouragement by HPs to be physically active than before (26%; N=243, p<0.000). HPs (N=288) on an average reported encouraging patients more often after the intervention, but this difference was significant only for occupational therapists and KBs. Based on patient's reports of HP behaviour, the KB-intervention appears effective since more patients felt encouraged to be physically active after the intervention compared to before. Replication of this study in an experimental design is needed to allow causal inferences. Implications for rehabilitation We advise rehabilitation teams to make use of knowledge brokers (KBs), since the KB-intervention was shown to increase the encouragement felt by stroke patients to be physically active. It seems worthwhile to involve physicians, nurses and patients' families more frequently in efforts to encourage stroke patients to be physically active.

Evaluation of efficacy and tolerability of fixed dose combination of ofloxacin with ornidazole infusion (infusion O2) in the management of diarrhoea and dysentery.

PubMed

Faruqui, Arif A; Joshi, Chandrakant

2012-03-01

Acute diarrhoea in adults is one of the most commonly encountered medical emergency in general practice and is responsible for considerable morbidity around the world. To evaluate the efficacy and tolerability of fixed dose combination of ofloxacin with ornidazole infusion (infusion O2) in the management of diarrhoea and dysentery, a study was carried out among 290 patients, age group from 18 to 65 years suffering from diarrhoea, dysentery, gastro-enteritis. Study drug infusion O2, (Medley Pharmaceutical, Mumbai) containing ofloxacin 200 mg + ornidazole 500 mg was administrated twice daily for a duration of 5 days. Number of soft or watery stool, body temperature, nausea, abdominal pain, gas and flatulence were recorded at baseline and at the end of the study. Tolerability and efficacy was evaluated based on the global assessment by the investigator based on a 3-point scale marked as excellent/good/poor. Two hundred and fifty-six-patients (160 male and 96 female) were included for final analysis, 34 patients lost to follow-up. Mean number of watery stool per day was reduced from 9.273 +/- 0.4537 to 1.375 +/- 0.07001 (p < 0.0001) by infusion O2. Body temperature was significantly reduced from 38.055 +/- 0.045 degrees C to 36.778 +/- 0.016 degrees C (p < 0.0001) at the end of the study. Pretreatment symptom nausea was significantly reduced in 90.34% of patients. Improvement in vomiting symptoms was reported in 72.35% of patients after administration of anti-emetic drug; 96.84% and 77.25% of patients reported improvement in abdominal pain and gas/flatulence respectively at the end of the trial by infusion O2. As per investigators' assessment about efficacy of trial drug, 98.43% of patients reported good to excellent and 1.56% reported poor efficacy. As per investigators' assessment about tolerability 98.43% of patients reported good to excellent and 1.17% reported poor tolerability. Minor incidences of nausea, gastritis, metallic taste were reported in 7.42%, 7.14%, and 5.85% of patients respectively. No serious adverse events were reported which led to withdrawal of patient from the study. Result of this study shows that, combination of ofloxacin with ornidazole infusion (infusion O2) significantly reduces number of watery stool and associated symptoms like nausea, abdominal pain, flatulence/gas with excellent tolerability.

A Systematic Review of the Unintended Consequences of Clinical Interventions to Reduce Adverse Outcomes.

PubMed

Manojlovich, Milisa; Lee, Soohee; Lauseng, Deborah

2016-12-01

This is a systematic review of the literature on unintended consequences of clinical interventions to reduce falls, catheter-related urinary tract infection, and vascular catheter-related infections in hospitalized patients. A systematic search of the literature was conducted in CINAHL and PubMed. We developed a screening tool and a two-stage screening process to identify relevant articles. Nine articles met inclusion criteria, and of those, 8 reported on interventions to reduce patient falls. Four studies reported a positive, unexpected benefit; 3 studies reported a negative, unexpected detriment; and 4 reported a perverse effect (different from what was expected). Three studies reported both positive and perverse effects arising from the intervention. In 4 of the studies, despite fall prevention interventions, patients fell while trying to get to the bathroom, suggesting that interventions to reduce one adverse outcome (i.e., CAUTI) may be associated with another outcome (i.e., patient falls). In some cases, there were positive outcomes for those who implemented and/or evaluated interventions. We encourage colleagues to collect and report data on possible unintended consequences of their interventions to allow a fuller picture of the relationship between intervention and all outcomes to emerge.

[The effectiveness of error reporting promoting strategy on nurse's attitude, patient safety culture, intention to report and reporting rate].

PubMed

Kim, Myoungsoo

2010-04-01

The purpose of this study was to examine the impact of strategies to promote reporting of errors on nurses' attitude to reporting errors, organizational culture related to patient safety, intention to report and reporting rate in hospital nurses. A nonequivalent control group non-synchronized design was used for this study. The program was developed and then administered to the experimental group for 12 weeks. Data were analyzed using descriptive analysis, X(2)-test, t-test, and ANCOVA with the SPSS 12.0 program. After the intervention, the experimental group showed significantly higher scores for nurses' attitude to reporting errors (experimental: 20.73 vs control: 20.52, F=5.483, p=.021) and reporting rate (experimental: 3.40 vs control: 1.33, F=1998.083, p<.001). There was no significant difference in some categories for organizational culture and intention to report. The study findings indicate that strategies that promote reporting of errors play an important role in producing positive attitudes to reporting errors and improving behavior of reporting. Further advanced strategies for reporting errors that can lead to improved patient safety should be developed and applied in a broad range of hospitals.

Measuring deception: test-retest reliability of physicians' self-reported manipulation of reimbursement rules for patients.

PubMed

VanGeest, Jonathan B; Wynia, Matthew K; Cummins, Deborah S; Wilson, Ira B

2002-06-01

This study examined the test-retest reliability of physicians' self-reported manipulation of reimbursement rules for patients. The test-retest reliability of self-report of three specific tactics were examined: (1) exaggerating the severity of patients' conditions, (2) changing a patient's official (billing) diagnosis, and (3) reporting signs or symptoms that patients did not have. The reliability of a scaled summary measure of physicians' manipulation of reimbursement rules was also assessed. Overall, the authors found high levels of test-retest agreement across all three items and the summary measure. These findings suggest that self-report can be used to produce reliable data on this controversial issue. Specifically, the three items reported here can be used to produce a reliable summary measure of physicians' manipulation of reimbursement rules to help patients obtain care that physicians perceive as necessary.

Informing primary care reform in Greece: patient expectations and experiences (the QUALICOPC study).

PubMed

Lionis, Christos; Papadakis, Sophia; Tatsi, Chrysanthi; Bertsias, Antonis; Duijker, George; Mekouris, Prodromos-Bodosakis; Boerma, Wienke; Schäfer, Willemijn

2017-04-05

Primary health care is the cornerstone of a high quality health care system. Greece has been actively attempting to reform health care services in order to improve heath outcomes and reduce health care spending. Patient-centered approaches to health care delivery have been increasingly acknowledged for their value informing quality improvement activities. This paper reports the quality of primary health care services in Greece as perceived by patients and aspects of health care delivery that are valued by patients. This study was conducted as part of the Quality and Costs of Primary Care in Europe (QUALICOPC) study. A cross-sectional sample of patients were recruited from general practitioner's offices in Greece and surveyed. Patients rated five features of person-focused primary care: accessibility; continuity and coordination; comprehensiveness; patient activation; and doctor-patient communication. One tenth of the patients ranked the importance of each feature on a scale of one to four, and nine tenths of patients scored their experiences of care received. Comparisons were made between patients with and without chronic disease. The sample included 220 general practitioners from both public and private sector. A total of 1964 patients that completed the experience questionnaire and 219 patients that completed the patient values questionnaire were analyzed. Patients overall report a positive experiences with the general practice they visited. Several gaps were identified in particular in terms of wait times for appointments, general practitioner access to patient medical history, delivery of preventative services, patient involvement in decision-making. Patients with chronic disease report better experience than respondents without a chronic condition, however these patient groups report the same values in terms of qualities of the primary care system that are important to them. Data gathered may be used to improve the quality of primary health care services in Greece through an increased focus on patient-centered approaches. Our study has identified several gaps as well as factors within the primary care health system that patient's perceive as most important which can be used to prioritize quality improvement activities, especially within the austerity period. Study findings may also have application to other countries with similar context and infrastructure.

A prospective qualitative study on patients' perceptions of endoscopic endonasal transsphenoidal surgery.

PubMed

Edem, Idara J; Banton, Beverly; Bernstein, Mark; Lwu, Shelly; Vescan, Allan; Gentilli, Fred; Zadeh, Gelareh

2013-02-01

Endoscopic transsphenoidal surgery has been shown to be a safe and effective treatment option for patients with pituitary tumours, but no study has explored patients' perceptions before and after this surgery. The authors in this study aim to explore patients' perceptions on endoscopic transsphenoidal surgery. Using qualitative research methodology, two semi-structured interviews were conducted with 30 participants who were adults aged > 18 undergoing endoscopic transsphenoidal surgery for the resection of a pituitary tumour between December 2008 and June 2011. The interviews were audiotaped and transcribed. The resulting data was analyzed using a modified thematic analysis. Seven overarching themes were identified: (1) Patients had a positive surgical experience; (2) patients were satisfied with the results of the procedure; (3) patients were initially surprised that neurosurgery could be performed endonasally; (4) patients expected a cure and to feel better after the surgery; (5) many patients feared that something might go wrong during the surgery; (6) patients were psychologically prepared for the surgery; (7) most patients reported receiving adequate pre-op and post-op information. This is the first qualitative study reporting on patients' perceptions before and after an endoscopic endonasal transsphenoidal pituitary surgery, which is increasingly used as a standard surgical approach for patients with pituitary tumours. Patients report a positive perception and general satisfaction with the endoscopic transsphenoidal surgical experience. However, there is still room for improvement in post-surgical care. Overall, patients' perceptions can help improve the delivery of comprehensive care to future patients undergoing pituitary tumour surgery.

Chronic fatigue in patients with unexplained self-reported food hypersensitivity and irritable bowel syndrome: validation of a Norwegian translation of the Fatigue Impact Scale.

PubMed

Lind, Ragna; Berstad, Arnold; Hatlebakk, Jan; Valeur, Jørgen

2013-01-01

Patients with unexplained self-reported food hypersensitivity and irritable bowel syndrome (IBS) suffer from several health complaints, including fatigue. The aim of the present study was to validate a Norwegian translation of the Fatigue Impact Scale (FIS), and to assess the impact of fatigue in patients with self-reported food hypersensitivity and IBS, as compared with healthy controls. Thirty-eight patients with unexplained self-reported food hypersensitivity and IBS, who participated in the validation of the FIS completed the following additional questionnaires: the Short Form of Nepean Dyspepsia Index for assessment of quality of life, the Subjective Health Complaint Inventory, and questionnaires for diagnosis and severity of IBS. Impact of fatigue was studied in 43 patients with unexplained self-reported food hypersensitivity, 70% diagnosed with IBS, and 42 healthy controls. Cronbach's α for the FIS was 0.98, indicating excellent agreement between individual items. Scores on the FIS correlated with scores on the Short Form of Nepean Dyspepsia Index (r = 0.50, P = 0.001), indicating good convergent validity, and were higher in patients (median 85.0, interquartile range 36.8-105.3) than in controls (median 14.0, interquartile range 3.0-29.0, P ≤ 0.0001). The Norwegian translation of the FIS performed excellently in patients with unexplained self-reported food hypersensitivity and IBS, with patients reporting significantly more impact of chronic fatigue than healthy controls.

How might health services capture patient-reported safety concerns in a hospital setting? An exploratory pilot study of three mechanisms.

PubMed

O'Hara, Jane Kathryn; Armitage, Gerry; Reynolds, Caroline; Coulson, Claire; Thorp, Liz; Din, Ikhlaq; Watt, Ian; Wright, John

2017-01-01

Emergent evidence suggests that patients can identify and report safety issues while in hospital. However, little is known about the best method for collecting information from patients about safety concerns. This study presents an exploratory pilot of three mechanisms for collecting data on safety concerns from patients during their hospital stay. Three mechanisms for capturing safety concerns were coproduced with healthcare professionals and patients, before being tested in an exploratory trial using cluster randomisation at the ward level. Nine wards participated, with each mechanism being tested over a 3-month study period. Patients were asked to feed back safety concerns via the mechanism on their ward (interviewing at their bedside, paper-based form or patient safety 'hotline'). Safety concerns were subjected to a two-stage review process to identify those that would meet the definition of a patient safety incident. Differences between mechanisms on a range of outcomes were analysed using inferential statistics. Safety concerns were thematically analysed to develop reporting categories. 178 patients were recruited. Patients in the face-to-face interviewing condition provided significantly more safety concerns per patient (1.91) compared with the paper-based form (0.92) and the patient safety hotline (0.43). They were also significantly more likely to report one or more concerns, with 64% reporting via the face-to-face mechanism, compared with 41% via the paper-based form and 19% via the patient safety hotline. No mechanism differed significantly in the number of classified patient safety incidents or physician-rated preventability and severity. Interviewing at the patient's bedside is likely to be the most effective means of gathering safety concerns from inpatients, potentially providing an opportunity for health services to gather patient feedback about safety from their perspective. 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/.

Can patients with asthma feel inhaler therapy working right away? Two clinical trials testing the effect of timing of assessment on patient perception.

PubMed

Leidy, Nancy Kline; Gutierrez, Benjamin; Lampl, Kathy; Uryniak, Tom; O'Brien, Christopher D

2009-12-01

Feeling a maintenance therapy work right away may provide positive reinforcement and may offer one way to improve adherence in patients with asthma. Precise measurement is required to accurately compare the presence of this effect across clinical trial treatment groups. Two randomized, controlled studies tested whether timing of assessment (daily vs weekly, study 1; and predose vs postdose, study 2) influenced patients' reports of whether they can feel a medication working right away (perception), and their satisfaction with this perception (satisfaction). These 2-week US-based multicenter double-blind, parallel-group studies included patients > or = 18 years of age with mild to moderate persistent asthma. In each, patients were randomized to one of two drugs with different onset profiles: budesonide/formoterol pressurized metered-dose inhaler (pMDI) 80/4.5 microg x 2 inhalations (160/9 microg) twice daily or budesonide pMDI 80 microg x 2 inhalations (160 microg) twice daily. Patients were further randomized to complete previously validated perception and satisfaction questions in a cross-over fashion, either daily and weekly (N = 123) or predose and postdose (N = 134). Patient surveys also assessed perceptions of the onset of effect of medication and their value of these perceptions. No significant differences were observed in patients' reports of perception, either daily versus weekly or predose versus postdose. A statistically significant difference in satisfaction was found in study 1 only, favoring weekly recall (p < 0.05), with sensitivity analysis showing no difference by treatment group (p = 0.162). Across both studies, most patients (87%) who perceived their inhaler working right away (136 of 157 patients) identified positive airway sensations. Most patients reported that feeling their medication work right away is reassuring and would help them manage their asthma. Assessment timing has no effect on patient response to the perception of feeling a medication working right away. Differences found in satisfaction levels reported with weekly versus daily recall were consistent across treatment groups, indicating that no bias was introduced in favor of either treatment group. Patients characterized the perception of feeling a maintenance therapy working right away as easier breathing and reported this perception as beneficial to patient self-care.

Physical and Mental Health Trajectories of Cancer Patients and Caregivers Across the Year Post-Diagnosis: A Dyadic Investigation

PubMed Central

Shaffer, Kelly M.; Kim, Youngmee; Carver, Charles S.

2016-01-01

Objective Evidence suggests interdependence between cancer patients’ and their caregivers’ physical and mental health. However, the extent to which caregivers’ health relates to their patients’ recovery, or patients’ health affects their caregivers’ outcomes, is largely unknown. This dyadic investigation reports the relations between cancer patients’ and their caregivers’ physical and mental health trajectories during the year following diagnosis. Design Ninety-two colorectal cancer patient-caregiver dyads completed questionnaires at two, six, and twelve months post-diagnosis. Outcome Measures Self-reported physical and mental health using the Medical Outcomes Study Short Form Health Survey-12. Results Patients reported improved physical health over the year following their diagnosis, whereas caregivers reported declining physical health. Patients with lower mental health at diagnosis had stagnated physical health recovery. Caregivers’ physical health declined most noticeably among those reporting low mental health at diagnosis and whose patients reported low physical health at diagnosis. Conclusion Findings suggest targeting health interventions to cancer patients and caregivers reporting poor mental health at diagnosis may mitigate their long-term physical morbidity. Limited evidence of dyadic interdependence between patients’ and caregivers’ physical and mental health trajectories suggests future studies are warranted to identify psychosocial and medical characteristics moderating the relations between patients’ and caregivers’ health. PMID:26680247

Patient-reported outcomes (PRO) focused on adverse events (PRO-AEs) in adjuvant and metastatic breast cancer: clinical and translational implications.

PubMed

Stefanovic, Stefan; Wallwiener, Markus; Karic, Uros; Domschke, Christoph; Katic, Luka; Taran, Florin-Andrei; Pesic, Aleksandra; Hartkopf, Andreas; Hadji, Peyman; Teufel, Martin; Schuetz, Florian; Sohn, Christof; Fasching, Peter; Schneeweiss, Andreas; Brucker, Sara

2017-02-01

The capture of adequate treatment outcomes and quality of life (QOL) of advanced breast cancer patients in clinical routine represents a great challenge. Patient-reported outcomes (PROs) are data elements directly reported by patients about experiences with care, including symptoms, functional status, or quality of life. There is growing interest in the medical community for the evaluation and implementation of PROs of adverse events (PRO-AEs). Recent interest in PROs in health care has evolved in the context of patient centeredness. Our primary objective was to identify trials that had implemented PRO-AEs in the breast cancer treatment setting, thereby demonstrating its feasibility. We aimed to identify published studies that used patient reports to assess AEs during and after breast cancer treatment, to identify clinician underreported and modifiable AEs that are important to patients, and to analyze the feasibility and usefulness of PRO instrument implementation in everyday oncological practice with special attention given to electronic-based PRO instruments. We conducted a systematic search of PubMed for studies that used PRO instruments to assess AEs of breast cancer treatment in the metastatic and adjuvant settings. Two authors independently reviewed the search results and decided which studies fully met the predefined inclusion criteria. The search yielded 606 publications. The two reviewers found that 9 studies met the inclusion criteria. Three AEs were identified as important to patients but inadequately reported by health care providers, namely hot flushes, vaginal dryness, and weight gain. PROs and PRO-AEs are the consequence of contemporary concepts of patient-centered medicine and the growing feasibility, utility, and implications of collecting data using modern technology. Furthermore, the willingness of patients to utilize innovative applications for their own health has been increasing in parallel to the enhanced impact of the World Wide Web. Especially, the coverage of the metastatic situation promises numerous findings on the structure and quality of health care, enabling implementation of individually tailored interventions. Remote electronic self-reporting (i.e., home reporting) is feasible and is associated with high compliance levels.

Surveillance of patients with acute flaccid paralysis in Finland: report of a pilot study.

PubMed Central

Hovi, T.; Stenvik, M.

2000-01-01

WHO recommends that surveillance of patients with acute flaccid paralysis (AFP) be used to demonstrate the eradication of wild poliovirus. In this article we report the results of a study to assess the frequency of AFP patients referred to Finnish hospitals and whether virological diagnostic coverage could be improved by repeated reminders and active feedback. For this purpose, we sent monthly questionnaires to all neurological and paediatric neurological units in Finland, requesting retrospective reporting on investigated paralytic patients with defined clinically relevant diagnoses, rather than AFP. Reminder letters included a pre-paid return envelope. Virological investigations were offered cost free. Of the 492 reporting forms sent, 415 (84%) were returned, evenly covering both the population and the study period (July 1997 to June 1998). Of the 90 patients reported, 83 were evaluable. The apparent incidences of the diagnoses covered were 1.6 per 100,000 at any age, and 1.0 per 100,000 for under--15-year-olds. Guillain-Barré syndrome was the most common diagnosis (0.80 per 100,000). The two faecal specimens required were virologically investigated in nine out of the 10 patients under 15 years of age, but in only 46% of all patients. Four adenovirus strains, but no polioviruses or other enteroviruses, were isolated. We conclude that a satisfactory monthly reporting system was readily established and that a sufficient number of patients with diagnoses resembling AFP are being referred to Finnish hospitals. Active feedback did not increase the proportion of virologically investigated patients to an acceptable level in all age groups. It is clear that other approaches must be used to quantify the circulation of poliovirus in Finland. PMID:10812725

Analysis of pain and painless symptoms in temporomandibular joints dysfunction in adult patients.

PubMed

Górecka, Małgorzata; Pihut, Małgorzata; Kulesa-Mrowiecka, Małgorzata

2017-01-01

Recent years have shown an increase in the number of patients reporting for treatment of pain due to musculoskeletal joint, associated with temporomandibular joint dysfunction. Therefore, studies were undertaken, aimed at analyzing the symptoms of the dysfunction, because of which patients come to the prosthetic treatment. Aim of the thesis: The aim of the study was a retrospective analysis of symptoms of temporomandibular joint dysfunction reported by patients diagnosed with this problem. The research material was a retrospective medical records of 120 patients, aged 19 to 45 years who have taken prosthetic treatment due to temporomandibular joint dysfunction in the Consulting Room in Prosthetics Department in Kraków, from June 2015 to December 2016. During the test patients, in addition to interviewing a physician, completed a personal survey in their own study. The material has been divided into I group of patients who reported pain form of dysfunction and II group, who had no symptoms of pain within the stomatognatic system. The analysis covered type of symptoms, the share of local factors (para-functions) and systemic, as well as the time a er which the patients reported for the treatment of functional disorders since the appearance of the first symptoms. Analysis of the research material showed that the main reason for reporting patients was pain in one or both temporal joints of significant intensity (5 to 8 in VAS scale,) accompanied by acoustic symptoms. A large group of questioners reported problems with the range of jaw movement and head and face pain, as well as subjective symptoms from the auditory, sight, neck, neck and shoulder areas.

Safety and tolerability of cladribine tablets in multiple sclerosis: the CLARITY (CLAdRIbine Tablets treating multiple sclerosis orallY) study.

PubMed

Cook, S; Vermersch, P; Comi, G; Giovannoni, G; Rammohan, K; Rieckmann, P; Sørensen, P Soelberg; Hamlett, A; Miret, M; Weiner, J; Viglietta, V; Musch, B; Greenberg, S J

2011-05-01

Cladribine is a synthetic deoxyadenosine analogue in development as an oral multiple sclerosis (MS) therapy. To report in detail the safety findings from the 96-week, phase III, double-blind CLARITY study, which evaluated treatment with cladribine tablets in relapsing-remitting MS. A total of 1,326 patients were randomized 1:1:1 to two short-course regimens of cladribine tablets (3.5 or 5.25 mg/kg cumulative dose over 96 weeks) or placebo. Safety assessments included monitoring for adverse events (AEs), routine physical and neurologic examinations and frequent laboratory parameter assessments. Of the randomized patients, 88.6% completed treatment with cladribine tablets versus 86.3% with placebo. Lymphopenia was the most commonly reported AE in patients treated with cladribine tablets and was anticipated based on the mechanism of action. The incidence of infections was 48.3% with cladribine tablets and 42.5% with placebo, with 99.1% and 99.0% rated mild-to-moderate by investigators. Herpes zoster infections developed in 20 (2.3%) cladribine-treated patients; all cases were dermatomal. There were no herpes zoster infections in the placebo group. Nine (1.0%) patients experienced events related to uterine leiomyomas in the cladribine tablets groups versus one (0.2%) with placebo. Three isolated cases of malignancy were reported in cladribine-treated patients during the study; a fourth was reported during post-study surveillance. A pre-malignant cervical carcinoma in situ was also reported. The incidence of malignancies during the study did not exceed the expected rate in a population standardized for country, gender and age. The safety and tolerability profile observed in the CLARITY study together with the reported efficacy support the potential for cladribine tablets as an MS therapy.

Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial

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

Basch, Ethan, E-mail: ebasch@med.unc.edu; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina; Pugh, Stephanie L.

Purpose: To assess the feasibility of measuring symptomatic adverse events (AEs) in a multicenter clinical trial using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Methods and Materials: Patients enrolled in NRG Oncology's RTOG 1012 (Prophylactic Manuka Honey for Reduction of Chemoradiation Induced Esophagitis-Related Pain during Treatment of Lung Cancer) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly ×4 during treatment; 12 weeks after treatment). Reporting was conducted via wireless tablet computers in clinic waiting areas. Compliance was defined as the proportion of visitsmore » when an expected PRO-CTCAE assessment was completed. Results: Among 226 study sites participating in RTOG 1012, 100% completed 35-minute PRO-CTCAE training for clinical research associates (CRAs); 80 sites enrolled patients, of which 34 (43%) required tablet computers to be provided. All 152 patients in RTOG 1012 agreed to self-report using the PRO-CTCAE (median age 66 years; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range, 30-240 minutes), and median time for CRAs to teach a patient to self-report was 10 minutes (range, 2-60 minutes). Compliance was high, particularly during active treatment, when patients self-reported at 86% of expected time points, although compliance was lower after treatment (72%). Common reasons for noncompliance were institutional errors, such as forgetting to provide computers to participants; patients missing clinic visits; Internet connectivity; and patients feeling “too sick.” Conclusions: Most patients enrolled in a multicenter chemoradiotherapy trial were willing and able to self-report symptomatic AEs at visits using tablet computers. Minimal effort was required by local site staff to support this system. The observed causes of missing data may be obviated by allowing patients to self-report electronically between visits, and by using central compliance monitoring. These approaches are being incorporated into ongoing studies.« less

Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial.

PubMed

Basch, Ethan; Pugh, Stephanie L; Dueck, Amylou C; Mitchell, Sandra A; Berk, Lawrence; Fogh, Shannon; Rogak, Lauren J; Gatewood, Marcha; Reeve, Bryce B; Mendoza, Tito R; O'Mara, Ann M; Denicoff, Andrea M; Minasian, Lori M; Bennett, Antonia V; Setser, Ann; Schrag, Deborah; Roof, Kevin; Moore, Joan K; Gergel, Thomas; Stephans, Kevin; Rimner, Andreas; DeNittis, Albert; Bruner, Deborah Watkins

2017-06-01

To assess the feasibility of measuring symptomatic adverse events (AEs) in a multicenter clinical trial using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Patients enrolled in NRG Oncology's RTOG 1012 (Prophylactic Manuka Honey for Reduction of Chemoradiation Induced Esophagitis-Related Pain during Treatment of Lung Cancer) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly ×4 during treatment; 12 weeks after treatment). Reporting was conducted via wireless tablet computers in clinic waiting areas. Compliance was defined as the proportion of visits when an expected PRO-CTCAE assessment was completed. Among 226 study sites participating in RTOG 1012, 100% completed 35-minute PRO-CTCAE training for clinical research associates (CRAs); 80 sites enrolled patients, of which 34 (43%) required tablet computers to be provided. All 152 patients in RTOG 1012 agreed to self-report using the PRO-CTCAE (median age 66 years; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range, 30-240 minutes), and median time for CRAs to teach a patient to self-report was 10 minutes (range, 2-60 minutes). Compliance was high, particularly during active treatment, when patients self-reported at 86% of expected time points, although compliance was lower after treatment (72%). Common reasons for noncompliance were institutional errors, such as forgetting to provide computers to participants; patients missing clinic visits; Internet connectivity; and patients feeling "too sick." Most patients enrolled in a multicenter chemoradiotherapy trial were willing and able to self-report symptomatic AEs at visits using tablet computers. Minimal effort was required by local site staff to support this system. The observed causes of missing data may be obviated by allowing patients to self-report electronically between visits, and by using central compliance monitoring. These approaches are being incorporated into ongoing studies. Copyright © 2017 Elsevier Inc. All rights reserved.

Taste disorders after tonsillectomy: a long-term follow-up.

PubMed

Heiser, Clemens; Landis, Basile N; Giger, Roland; Cao Van, Helene; Guinand, Nils; Hörmann, Karl; Stuck, Boris A

2012-06-01

In a former study, taste disturbances after tonsillectomy seemed to be more frequent than expected. Eight percent of patients reported subjective taste disorders 6 months after tonsillectomy. Fifteen patients from the initial trial, who reported taste disorders after tonsillectomy, were contacted again for this long-term follow-up. A telephone interview using the same questionnaire addressing the current self-estimate of taste function was performed. At 32 ± 10 months following surgery, two (0.9%) patients still reported suffering from taste disturbance. This long-term follow-up study shows that dysgeusia following tonsillectomy occurs in approximately 1% of patients. These data should be considered when patients are informed about complications after tonsillectomy. Copyright © 2012 The American Laryngological, Rhinological, and Otological Society, Inc.

Characteristics of methadone maintenance treatment patients prescribed opioid analgesics.

PubMed

Glenn, Matthew C; Sohler, Nancy L; Starrels, Joanna L; Maradiaga, Jeronimo; Jost, John J; Arnsten, Julia H; Cunningham, Chinazo O

2016-01-01

Opioid analgesic use and disorders have dramatically increased among the general American population and those receiving methadone maintenance treatment (MMT). Most research among MMT patients focuses on opioid analgesics misuse or disorders; few studies focus on MMT patients prescribed opioid analgesics. We describe demographic, clinical, and substance use characteristics of MMT patients prescribed opioid analgesics and compare them with MMT patients not prescribed opioid analgesics. We conducted a cross-sectional secondary data analysis using screening interviews from a parent study. From 2012 to 2015, we recruited adults from 3 MMT Bronx clinics. Questionnaire data included patterns of opioid analgesic use, substance use, comorbid illnesses, and demographic characteristics. Our main dependent variable was patients' report of currently taking prescribed opioid analgesics. To compare characteristics between MMT patients prescribed and not prescribed opioid analgesics, we conducted chi-square tests, t tests, and Mann-Whitney U tests. Of 611 MMT patients, most reported chronic pain (62.0%), hepatitis C virus (HCV) infection (52.1%), and current use of illicit substances (64.2%). Of the 29.8% who reported currently taking prescribed opioid analgesics, most misused their opioid analgesics (57.5%). Patients prescribed (versus not prescribed) opioid analgesics were more likely to report human immunodeficiency virus (HIV) infection (adjusted odds ratio [aOR] = 1.6, 95% confidence interval [CI]: 1.1-2.3) and chronic pain (aOR = 7.6, 95% CI: 4.6-12.6). Among MMT patients primarily in 3 Bronx clinics, nearly one third reported taking prescribed opioid analgesics. Compared with patients not prescribed opioid analgesics, those prescribed opioid analgesics were more likely to report chronic pain and HIV infection. However, between these patients, there was no difference in illicit substance use. These findings highlight the complexity of addressing chronic pain in MMT patients.

A cross-sectional survey among patients and prescribers on insulin dosing irregularities and impact of mild (self-treated) hypoglycemia episodes in Spanish patients with type 2 diabetes as compared to other European patients.

PubMed

Ampudia-Blasco, Francisco J; Galán, Manuel; Brod, Meryl

2014-10-01

In Spain, data suggest that 13.8% of adults have diabetes. Two important aspects in diabetes management are mild hypoglycemic episodes and poor treatment adherence. This study assesses the impact of missed insulin doses and prevalence of mistimed and reduced insulin doses and mild hypoglycemia in patients with type 2 diabetes treated with basal insulin analogues in Spain, and compares the data collected to pooled data from 8 other European countries (OECs). GAPP2 was an international, online, cross-sectional study of diabetic patients aged ≥40 years treated with long-acting insulin analogues and their healthcare professionals. Patients and healthcare professionals were recruited from online research panels. Data reported in Spain are compared to pooled data from 8 OECs. In Spain, 1-3% of patients reported they had reduced, missed, or mistimed at least one insulin does in the previous month. Significantly more OEC patients reported dosing irregularities (15-23%; all P<0.01). In Spain, 77% of patients were worried and 59% felt guilty for missing a dose of basal insulin, while 24% reported that they were very worried about nocturnal hypoglycemia. Significantly fewer OEC patients reported worrying (47%; P<0.01) and feeling guilty (37%; P<0.01) about missing an insulin dose, or worry about nocturnal hypoglycemia (12%; P<0.01). In Spain, patients with type 2 diabetes report fewer dosing irregularities and hypoglycemic episodes as compared to patients from OECs. However, Spanish patients appear to have a reduced quality of life related to hypoglycemia as well as worry and guilt related to insulin dosing irregularities. Copyright © 2014 SEEN. Published by Elsevier Espana. All rights reserved.

Clinical assessment and patient-reported outcome measures in low-back pain - a survey among primary health care physiotherapists.

PubMed

Östhols, Sara; Boström, Carina; Rasmussen-Barr, Eva

2018-05-09

We aimed to map the physiotherapy practice in Sweden of clinical tests and patient-reported outcome measures in low-back pain (LBP), and to study advantages and barriers in using patient-reported outcome measures. An online survey was mailed to 4934 physiotherapists in primary health care in Sweden. Multiple choice questions investigated the use of clinical tests and patient-reported outcome measures in assessing patients with LBP. Open questions investigating the advantages and barriers to the use of patient-reported outcome measures were analyzed with content analysis. The response rate was 25% (n = 1217). Clinical tests were used "always/often" by >60% of the participants, while most patient-reported outcome measures were used by <15%. Advantages in using patient-reported outcome measures were: the clinical reasoning process, to increase the quality of assessment, to get the patient's voice, education and motivation of patients, and communication with health professionals. Barriers were lack of time and knowledge, administrative aspects, the interaction between physiotherapist and patient and, the applicability and validity of the patient-reported outcome measures. Our findings show that physiotherapists working in primary health care use clinical testing in LBP to a great extent, while various patient-reported outcome measures are used to a low-to-very-low extent. Several barriers to the use of patient-reported outcome measures were reported such as time, knowledge, and administrative issues, while important findings on advantages were to enhance the clinical reasoning process and to educate and motivate the patient. Barriers might be changed through education or organizational change-work. To enhance the use of patient-reported outcome measures and thus person-centered care in low-back pain, recommendation, and education on various patient-reported outcome measures need to be advocated. Implications for rehabilitation To increase the effects of rehabilitation in low-back pain, yellow flags, and other factors need to be taken into the consideration in the assessment which means the use of patient-reported outcome measures in addition to clinical testing. The use of patient-reported outcome measures is an advantage in the clinical reasoning process to enhance the quality of assessment and to educate and motivate the patient. Barriers to use patient-reported outcome measures are mainly lack of time and knowledge, and administrative aspects. Through education or organizational change-work, barriers to the use of patient-reported outcome measures might be changed.

Combined use of clozapine and ECT: a review.

PubMed

Grover, Sandeep; Hazari, Nandita; Kate, Natasha

2015-06-01

This paper aims to review the available evidence for the use of clozapine and electroconvulsive therapy (ECT) in combination. Electronic searches were carried out to identify reports describing the combined use of clozapine and ECT. Forty reports including 208 patients were identified. The majority of reports were in the form of case reports and case series, with few retrospective and open-label studies. The majority of patients were aged between 18 and 65 years and diagnosed with schizophrenia or schizoaffective disorder. Most of the patients refractory to clozapine were started on ECT as an augmentation therapy; however, in some reports, both ECT and clozapine were started concurrently, and in few cases clozapine was started after ECT. In terms of effectiveness, 37.5-100% patients improved in short-term, and sustained long-term improvement (3 weeks to 24 months) was described in few studies. In terms of the side-effect profile, five patients each had delirium and tachycardia and only four patients were described to have prolonged seizures. Overall, the combination was considered effective and safe. There is evidence for the effectiveness and safety of the clozapine-ECT combination and it should be used in patients with treatment-resistant schizophrenia who do not respond to clozapine.

Correlation between Patient-Reported Symptoms and Ankle-Brachial Index after Revascularization for Peripheral Arterial Disease.

PubMed

Je, Hyung Gon; Kim, Bo Hyun; Cho, Kyoung Im; Jang, Jae Sik; Park, Yong Hyun; Spertus, John

2015-05-18

Improvement in quality of life (QoL) is a primary treatment goal for patients with peripheral arterial disease (PAD). The current study aimed to quantify improvement in the health status of PAD patients following peripheral revascularization using the peripheral artery questionnaire (PAQ) and ankle-brachial index (ABI), and to evaluate possible correlation between the two methods. The PAQ and ABI were assessed in 149 symptomatic PAD patients before, and three months after peripheral revascularization. Mean PAQ summary scores improved significantly three months after revascularization (+49.3 ± 15 points, p < 0.001). PAQ scores relating to patient symptoms showed the largest improvement following revascularization. The smallest increases were seen in reported treatment satisfaction (all p's < 0.001). As expected the ABI of treated limbs showed significant improvement post-revascularization (p < 0.001). ABI after revascularization correlated with patient-reported changes in the physical function and QoL domains of the PAQ. Twenty-two percent of PAD patients were identified as having a poor response to revascularization (increase in ABI < 0.15). Interestingly, poor responders reported improvement in symptoms on the PAQ, although this was less marked than in patients with an increase in ABI > 0.15 following revascularization. In conclusion, data from the current study suggest a significant correlation between improvement in patient-reported outcomes assessed by PAQ and ABI in symptomatic PAD patients undergoing peripheral revascularization.

Correlation between Patient-Reported Symptoms and Ankle-Brachial Index after Revascularization for Peripheral Arterial Disease

PubMed Central

Je, Hyung Gon; Kim, Bo Hyun; Cho, Kyoung Im; Jang, Jae Sik; Park, Yong Hyun; Spertus, John

2015-01-01

Improvement in quality of life (QoL) is a primary treatment goal for patients with peripheral arterial disease (PAD). The current study aimed to quantify improvement in the health status of PAD patients following peripheral revascularization using the peripheral artery questionnaire (PAQ) and ankle-brachial index (ABI), and to evaluate possible correlation between the two methods. The PAQ and ABI were assessed in 149 symptomatic PAD patients before, and three months after peripheral revascularization. Mean PAQ summary scores improved significantly three months after revascularization (+49.3 ± 15 points, p < 0.001). PAQ scores relating to patient symptoms showed the largest improvement following revascularization. The smallest increases were seen in reported treatment satisfaction (all p’s < 0.001). As expected the ABI of treated limbs showed significant improvement post-revascularization (p < 0.001). ABI after revascularization correlated with patient-reported changes in the physical function and QoL domains of the PAQ. Twenty-two percent of PAD patients were identified as having a poor response to revascularization (increase in ABI < 0.15). Interestingly, poor responders reported improvement in symptoms on the PAQ, although this was less marked than in patients with an increase in ABI > 0.15 following revascularization. In conclusion, data from the current study suggest a significant correlation between improvement in patient-reported outcomes assessed by PAQ and ABI in symptomatic PAD patients undergoing peripheral revascularization. PMID:25993299

Do patients have a say? A narrative review of the development of patient-reported outcome measures used in elective procedures for coronary revascularisation.

PubMed

Peeters, Geeske; Barker, Anna L; Talevski, Jason; Ackerman, Ilana; Ayton, Darshini R; Reid, Christopher; Evans, Sue M; Stoelwinder, Johannes U; McNeil, John J

2018-05-01

Patient-reported outcome measures (PROMs) capture health information from the patient's perspective that can be used when weighing up benefits, risks and costs of treatment. This is important for elective procedures such as those for coronary revascularisation. Patients should be involved in the development of PROMs to accurately capture outcomes that are important for the patient. The aims of this review are to identify if patients were involved in the development of cardiovascular-specific PROMs used for assessing outcomes from elective coronary revascularisation, and to explore what methods were used to capture patient perspectives. PROMs for evaluating outcomes from elective coronary revascularisation were identified from a previous review and an updated systematic search. The studies describing the development of the PROMs were reviewed for information on patient input in their conceptual and/or item development. 24 PROMs were identified from a previous review and three additional PROMs were identified from the updated search. Full texts were obtained for 26 of the 27 PROMs. The 26 studies (11 multidimensional, 15 unidimensional) were reviewed. Only nine studies reported developing PROMs using patient input. For eight PROMs, the inclusion of patient input could not be judged due to insufficient information in the full text. Only nine of the 26 reviewed PROMs used in elective coronary revascularisation reported involving patients in their conceptual and/or item development, while patient input was unclear for eight PROMs. These findings suggest that the patient's perspective is often overlooked or poorly described in the development of PROMs.

Outcomes After Shoulder and Elbow Injury in Baseball Players: Are We Reporting What Matters?

PubMed

Makhni, Eric C; Saltzman, Bryan M; Meyer, Maximilian A; Moutzouros, Vasilios; Cole, Brian J; Romeo, Anthony A; Verma, Nikhil N

2017-02-01

Return to play, as well as time to return to play, are the most important metrics considered by athletes when attempting to make treatment decisions after injury. However, the consistency of reporting of these metrics in the scientific literature is unknown. To investigate patterns of outcomes reporting in the medical literature of shoulder and elbow injuries in active baseball players. Systematic review. A systematic review of literature published within the past 10 years was performed to identify all recent clinical studies focusing on shoulder and elbow injuries in baseball players across all levels. Review articles, case reports, and laboratory/biomechanical studies were all excluded. A total of 49 studies were included for review. The majority of studies were either level 3 or level 4 evidence (96%). In total, 71% of studies reported on rates of return to preinjury level of play, whereas 31% of studies reported on time to return to preinjury level of play. Only 47% of studies reported on both rate and time of return to preinjury level of play. A minority of studies (8%) reported patient satisfaction rates. Finally, 27 different subjective and patient-reported outcomes were reported, and none of these appeared in more than 14% of all studies. Time to return to preinjury level of play is inadequately reported in studies of shoulder and elbow injury in baseball players. Similarly, satisfaction rates and scores are underreported. Finally, the significant variability of subjective and patient-reported outcomes utilized may undermine the ability of clinicians to accurately compare results from different studies.

Occipital and Cingulate Hypometabolism are Significantly Under-Reported on 18-Fluorodeoxyglucose Positron Emission Tomography Scans of Patients with Lewy Body Dementia.

PubMed

Hamed, Moath; Schraml, Frank; Wilson, Jeffrey; Galvin, James; Sabbagh, Marwan N

2018-01-01

To determine whether occipital and cingulate hypometabolism is being under-reported or missed on 18-fluorodeoxyglucose positron emission tomography (FDG-PET) CT scans in patients with Dementia with Lewy Bodies (DLB). Recent studies have reported higher sensitivity and specificity for occipital and cingulate hypometabolism on FDG-PET of DLB patients. This retrospective chart review looked at regions of interest (ROI's) in FDG-PET CT scan reports in 35 consecutive patients with a clinical diagnosis of probable, possible, or definite DLB as defined by the latest DLB Consortium Report. ROI's consisting of glucose hypometabolism in frontal, parietal, temporal, occipital, and cingulate areas were tabulated and charted separately by the authors from the reports. A blinded Nuclear medicine physician read the images independently and marked ROI's separately. A Cohen's Kappa coefficient statistic was calculated to determine agreement between the reports and the blinded reads. On the radiology reports, 25.71% and 17.14% of patients reported occipital and cingulate hypometabolism respectively. Independent reads demonstrated significant disagreement with the proportion of occipital and cingulate hypometabolism being reported on initial reads: 91.43% and 85.71% respectively. Cohen's Kappa statistic determinations demonstrated significant agreement only with parietal hypometabolism (p<0.05). Occipital and cingulate hypometabolism is under-reported and missed frequently on clinical interpretations of FDG-PET scans of patients with DLB, but the frequency of hypometabolism is even higher than previously reported. Further studies with more statistical power and receiver operating characteristic analyses are needed to delineate the sensitivity and specificity of these in vivo biomarkers.

Coping with Prescription Drug Cost Sharing: Knowledge, Adherence, and Financial Burden

PubMed Central

Reed, Mary; Brand, Richard; Newhouse, Joseph P; Selby, Joe V; Hsu, John

2008-01-01

Objective Assess patient knowledge of and response to drug cost sharing. Study Setting Adult members of a large prepaid, integrated delivery system. Study Design/Data Collection Telephone interviews with 932 participants (72 percent response rate) who reported knowledge of the structures and amounts of their prescription drug cost sharing. Participants reported cost-related changes in their drug adherence, any financial burden, and other cost-coping behaviors. Actual cost sharing amounts came from administrative databases. Principal Findings Overall, 27 percent of patients knew all of their drug cost sharing structures and amounts. After adjustment for individual characteristics, additional patient cost sharing structures (tiers and caps), and higher copayment amounts were associated with reporting decreased adherence, financial burden, or other cost-coping behaviors. Conclusions Patient knowledge of their drug benefits is limited, especially for more complex cost sharing structures. Patients also report a range of responses to greater cost sharing, including decreasing adherence. PMID:18370979

Ictal verbal help-seeking: Occurrence and the underlying etiology.

PubMed

Asadi-Pooya, Ali A; Asadollahi, Marjan; Bujarski, Krzysztof; Rabiei, Amin H; Aminian, Narsis; Wyeth, Dale; Sperling, Michael R

2016-11-01

Ictal verbal help-seeking has never been systematically studied before. In this study, we evaluated a series of patients with ictal verbal help-seeking to characterize its frequency and underlying etiology. We retrospectively reviewed all the long-term video-EEG reports from Jefferson Comprehensive Epilepsy Center over a 12-year period (2004-2015) for the occurrence of the term "help" in the text body. All the extracted reports were reviewed and patients with at least one episode of documented ictal verbal help-seeking in epilepsy monitoring unit (EMU) were studied. For each patient, the data were reviewed from the electronic medical records, EMU report, and neuroimaging records. During the study period, 5133 patients were investigated in our EMU. Twelve patients (0.23%) had at least one episode of documented ictal verbal help-seeking. Nine patients (six women and three men) had epilepsy and three patients (two women and one man) had psychogenic nonepileptic seizures (PNES). Seven out of nine patients with epilepsy had temporal lobe epilepsy; six patients had right temporal lobe epilepsy. Ictal verbal help-seeking is a rare finding among patients evaluated in epilepsy monitoring units. Ictal verbal help-seeking may suggest that seizures arise in or propagate to the right temporal lobe. Copyright © 2016 Elsevier Inc. All rights reserved.

Exploring relationships between hospital patient safety culture and Consumer Reports safety scores.

PubMed

Smith, Scott Alan; Yount, Naomi; Sorra, Joann

2017-02-16

A number of private and public companies calculate and publish proprietary hospital patient safety scores based on publicly available quality measures initially reported by the U.S. federal government. This study examines whether patient safety culture perceptions of U.S. hospital staff in a large national survey are related to publicly reported patient safety ratings of hospitals. The Agency for Healthcare Research and Quality Hospital Survey on Patient Safety Culture (Hospital SOPS) assesses provider and staff perceptions of hospital patient safety culture. Consumer Reports (CR), a U.S. based non-profit organization, calculates and shares with its subscribers a Hospital Safety Score calculated annually from patient experience survey data and outcomes data gathered from federal databases. Linking data collected during similar time periods, we analyzed relationships between staff perceptions of patient safety culture composites and the CR Hospital Safety Score and its five components using multiple multivariate linear regressions. We analyzed data from 164 hospitals, with patient safety culture survey responses from 140,316 providers and staff, with an average of 856 completed surveys per hospital and an average response rate per hospital of 56%. Higher overall Hospital SOPS composite average scores were significantly associated with higher overall CR Hospital Safety Scores (β = 0.24, p < 0.05). For 10 of the 12 Hospital SOPS composites, higher patient safety culture scores were associated with higher CR patient experience scores on communication about medications and discharge. This study found a relationship between hospital staff perceptions of patient safety culture and the Consumer Reports Hospital Safety Score, which is a composite of patient experience and outcomes data from federal databases. As hospital managers allocate resources to improve patient safety culture within their organizations, their efforts may also indirectly improve consumer-focused, publicly reported hospital rating scores like the Consumer Reports Hospital Safety Score.

Patient-Reported Disease-Modifying Therapy Adherence in the Clinic: A Reliable Metric?

PubMed

Conway, Devon S; Cecilia Vieira, Maria; Thompson, Nicolas R; Parker, Kaila N; Meng, Xiangyi; Fox, Robert J

2018-01-01

Adherence to multiple sclerosis (MS) disease-modifying therapy (DMT) is commonly assessed through patient reporting, but patient-reported adherence is rarely studied. To determine rates of DMT adherence reported from patient to clinician, reasons for nonadherence, and relationships between adherence and outcomes. We identified relapsing-remitting MS patients on DMT for ≥3 months. DMT adherence was defined as taking ≥80% of doses. Linear and logistic regression models were created used to determine the association of baseline adherence with several patient reported outcomes and the timed 25-foot walk at 6 months, 1 year, 2 years, and 3 years after the index visit. The analysis included 1148 patients, of whom 501 had data at 6 months, 544 at 1 year, 331 at 2 years, and 247 at 3 years. Baseline adherence was 94.9% and overall adherence was 93.1%. Forgetting was the most common reason for missed doses. In the adjusted models, adherence was not associated with the outcomes. Higher than expected adherence and a lack of association between adherence and outcomes suggests patient reported adherence may not be reliable. Further research is needed to clarify the relationship between patient-reported adherence and relapses or new lesion formation.

Comparison of patient-reported need of psycho-oncologic support and the doctor's perspective: how do they relate to disease severity in melanoma patients?

PubMed

Nolte, Sandra; van der Mei, Sicco H; Strehl-Schwarz, Kerstin; Köster, Johanna; Bender, Armin; Rose, Matthias; Kruse, Johannes; Peters, Eva M J

2016-11-01

Psycho-neuro-immune research suggests an association between cancer outcomes and psychosocial distress. Objective criteria to determine patients' levels of distress are important to establish potential links to disease outcomes. We compared three patient-reported with one doctor-reported measures of psycho-oncologic distress frequently used in routine cancer care and investigated associations with standard disease severity parameters in melanoma patients. We enrolled n = 361 patients, successively seen at two outpatient university clinics in Germany. In the naturalistic study, n = 222 patients had been diagnosed <180 days and were seen for the first time (Group I); n = 139 had been diagnosed >180 days and were in after-care (Group II). Across groups, only moderate associations were seen between patient- reported and doctor-reported measures. Regarding clinical variables, disease severity and perceived need of psycho-oncologic support reported by patients or doctors showed hardly any association. After subgroup stratification, in patients of Group II, patient-reported and doctor-reported instruments showed some small associations with disease parameters commonly linked to more rapid cancer progression in patients who are in cancer after-care. Overall, the few and low associations suggest that need of psycho-oncologic support and clinical variables were largely independent of each other and doctors' perception may not reflect the patient's view. Therefore, the assessment of the patient perspective is indispensable to ensure that melanoma patients receive appropriate support, as such need cannot be derived from other disease parameters or proxy report. More research is needed applying psychometrically robust instruments that are ideally combined with sensitive biomarkers to disentangle psycho-neuro-immune implications in melanoma patients. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Telephone follow-up for cataract surgery: feasibility and patient satisfaction study.

PubMed

Hoffman, Jeremy J S L; Pelosini, Lucia

2016-05-09

Purpose - The purpose of this paper is to investigate the feasibility of telephone follow-up (TFU) after uncomplicated cataract surgery in low-risk patients and patient satisfaction with this alternative clinical pathway. Design/methodology/approach - Prospective, non-randomised cohort study. A ten-point subjective ophthalmic assessment questionnaire and a six-point patient satisfaction questionnaire were administered to patients following routine cataract surgery at two to three weeks post-procedure. All patients were offered a further clinic review if required. Exclusion criteria comprised ophthalmic co-morbidities, hearing/language impairment and high risk of post-operative complications. Patient notes were retrospectively reviewed over the study period to ensure no additional emergency attendances took place. Findings - Over three months, 50 eyes of 50 patients (mean age: 80; age range 60-91; 66 per cent second eye surgery) underwent uncomplicated phacoemulsification surgery received a TFU at 12-24 days (mean: 16 days) post-operatively. Subjective visual acuity was graded as good by 92 per cent of patients; 72 per cent patients reported no pain and 20 per cent reported mild occasional grittiness. Patient satisfaction was graded 8.9 out of 10; 81.6 per cent defined TFU as convenient and 75.5 per cent of patients preferred TFU to routine outpatient review. No additional visits were required. Research limitations/implications - Non-randomised with no control group; small sample size. One patient was unable to be contacted. Practical implications - Post-operative TFU can be suitably targeted to low-risk patients following uncomplicated cataract surgery. This study demonstrated a high patient satisfaction. A larger, randomised study is in progress to assess this further. Originality/value - This is the first study reporting TFU results and patient satisfaction to the usual alternative two-week outpatient review.

Creating the Web-based Intensive Care Unit Safety Reporting System

PubMed Central

Holzmueller, Christine G.; Pronovost, Peter J.; Dickman, Fern; Thompson, David A.; Wu, Albert W.; Lubomski, Lisa H.; Fahey, Maureen; Steinwachs, Donald M.; Engineer, Lilly; Jaffrey, Ali; Morlock, Laura L.; Dorman, Todd

2005-01-01

In an effort to improve patient safety, researchers at the Johns Hopkins University designed and implemented a comprehensive Web-based Intensive Care Unit Safety Reporting System (ICUSRS). The ICUSRS collects data about adverse events and near misses from all staff in the ICU. This report reflects data on 854 reports from 18 diverse ICUs across the United States. Reporting is voluntary, and data collected is confidential, with patient, provider, and reporter information deidentified. Preliminary data include system factors reported, degree of patient harm, reporting times, and evaluations of the system. Qualitative and quantitative data are reported back to the ICU site study teams and frontline staff through monthly reports, case discussions, and a quarterly newsletter. PMID:15561794

Problems and Benefits Reported by Stroke Family Caregivers: Results from a Prospective Epidemiological Study

PubMed Central

Haley, William E.; Allen, Jessica Y.; Grant, Joan S.; Clay, Olivio J.; Perkins, Martinique; Roth, David L.

2009-01-01

Background and Purpose Stroke symptoms can be very stressful for family caregivers, but most knowledge about the prevalence and stressfulness of stroke-related patient problems is derived from convenience samples. In addition, little is known about perceived benefits of the stroke caregiving experience. The purpose of this study was to determine the prevalence and stressfulness of stroke-related problems, and perceived benefits of caregiving, as reported by an epidemiologically-derived sample of caregivers of stroke survivors. Methods Stroke survivors (N=75) from a prospective epidemiological study of stroke, the REasons for Geographic and Racial Differences in Stroke (REGARDS) study, and their family caregivers were followed. Caregivers were given a comprehensive telephone interview 8 to 12 months after the stroke, using measures of stroke patient problems, caregiver appraisals of the stressfulness of these problems, and perceived benefits of caregiving. Results Caregivers rated patient problems with mood (depression, loneliness and anxiety), memory, and physical care (bowel control), as the most stressful, but reported prevalence of these problems was lower than those reported previously in studies using clinical samples. Caregivers also reported many benefits from caregiving, with over 90% reporting that caregiving enabled them to appreciate life more. Conclusions Epidemiologically based studies of stroke caregiving provide a unique picture of caregiver strains and benefits compared with clinical studies, which tend to over-represent more impaired patients. Support for caregivers should include interventions to aid their coping with highly stressful mood, physical care, and cognitive problems of stroke patients, but should also attend to perceived benefits of caregiving. PMID:19407230

Information on new drugs at market entry: retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry reports

PubMed Central

Köhler, Michael; Haag, Susanne; Biester, Katharina; Brockhaus, Anne Catharina; McGauran, Natalie; Grouven, Ulrich; Kölsch, Heike; Seay, Ulrike; Hörn, Helmut; Moritz, Gregor; Staeck, Kerstin

2015-01-01

Background When a new drug becomes available, patients and doctors require information on its benefits and harms. In 2011, Germany introduced the early benefit assessment of new drugs through the act on the reform of the market for medicinal products (AMNOG). At market entry, the pharmaceutical company responsible must submit a standardised dossier containing all available evidence of the drug’s added benefit over an appropriate comparator treatment. The added benefit is mainly determined using patient relevant outcomes. The “dossier assessment” is generally performed by the Institute for Quality and Efficiency in Health Care (IQWiG) and then published online. It contains all relevant study information, including data from unpublished clinical study reports contained in the dossiers. The dossier assessment refers to the patient population for which the new drug is approved according to the summary of product characteristics. This patient population may comprise either the total populations investigated in the studies submitted to regulatory authorities in the drug approval process, or the specific subpopulations defined in the summary of product characteristics (“approved subpopulations”). Objective To determine the information gain from AMNOG documents compared with non-AMNOG documents for methods and results of studies available at market entry of new drugs. AMNOG documents comprise dossier assessments done by IQWiG and publicly available modules of company dossiers; non-AMNOG documents comprise conventional, publicly available sources—that is, European public assessment reports, journal publications, and registry reports. The analysis focused on the approved patient populations. Design Retrospective analysis. Data sources All dossier assessments conducted by IQWiG between 1 January 2011 and 28 February 2013 in which the dossiers contained suitable studies allowing for a full early benefit assessment. We also considered all European public assessment reports, journal publications, and registry reports referring to these studies and included in the dossiers. Data analysis We assessed reporting quality for each study and each available document for eight methods and 11 results items (three baseline characteristics and eight patient relevant outcomes), and dichotomised them as “completely reported” or “incompletely reported (including items not reported at all).” For each document type we calculated the proportion of items with complete reporting for methods and results, for each item and overall, and compared the findings. Results 15 out of 27 dossiers were eligible for inclusion and contained 22 studies. The 15 dossier assessments contained 28 individual assessments of 15 total study populations and 13 approved subpopulations. European public assessment reports were available for all drugs. Journal publications were available for 14 out of 15 drugs and 21 out of 22 studies. A registry report in ClinicalTrials.gov was available for all drugs and studies; however, only 11 contained results. In the analysis of total study populations, the AMNOG documents reached the highest grade of completeness, with about 90% of methods and results items completely reported. In non-AMNOG documents, the rate was 75% for methods and 52% for results items; journal publications achieved the best rates, followed by European public assessment reports and registry reports. The analysis of approved subpopulations showed poorer complete reporting of results items, particularly in non-AMNOG documents (non-AMNOG versus AMNOG: 11% v 71% for overall results items and 5% v 70% for patient relevant outcomes). The main limitation of our analysis is the small sample size. Conclusion Conventional, publicly available sources provide insufficient information on new drugs, especially on patient relevant outcomes in approved subpopulations. This type of information is largely available in AMNOG documents, albeit only partly in English. The AMNOG approach could be used internationally to develop a comprehensive publication model for clinical studies and thus represents a key open access measure. PMID:25722024

Prospective evaluation of patient-reported outcomes during treatment with deferasirox or deferoxamine for iron overload in patients with beta-thalassemia.

PubMed

Cappellini, Maria Domenica; Bejaoui, Mohamed; Agaoglu, Leyla; Porter, John; Coates, Thomas; Jeng, Michael; Lai, Maria Eliana; Mangiagli, Antonio; Strauss, Gabriele; Girot, Robert; Watman, Nora; Ferster, Alina; Loggetto, Sandra; Abish, Sharon; Cario, Holger; Zoumbos, Nicolaos; Vichinsky, Elliott; Opitz, Herbert; Ressayre-Djaffer, Catherine; Abetz, Linda; Rofail, Diana; Baladi, Jean-Francois

2007-05-01

Iron chelation therapy (ICT) with deferoxamine (DFO), the current standard for the treatment of iron overload in patients with transfusion-dependent disorders such as beta-thalassemia, requires regular subcutaneous or intravenous infusions. This can lead to reduced quality of life and poor adherence, resulting in increased morbidity and mortality in iron-overloaded patients with beta-thalassemia. Deferasirox is an orally administered iron chelator that has been approved for use in the United States, Switzerland, and other countries. This analysis was conducted to compare patient-reported outcomes (PROs) during receipt of DFO infusions or once-daily oral therapy with deferasirox (ICL670). PROs were prospectively evaluated as part of a randomized, Phase III study comparing the efficacy and safety profile of DFO 20 to 60 mg/kg per day with those of deferasirox 5 to 30 mg/kg per day in patients (age > or =2 years) with beta-thalassemia who were receiving regular transfusions and had a liver iron concentration of > or =2 mg/g dry weight. PRO questionnaires were completed by patients or a parent or legal guardian at baseline, week 4, week 24, and end of study (EOS). Patients assessed their level of satisfaction with study treatment (very satisfied, satisfied, neutral, dissatisfied, or very dissatisfied) and rated its convenience (very convenient, convenient, neutral, inconvenient, or very inconvenient). Time lost from normal activities due to ICT in the previous 4 weeks was recorded using a single global assessment. At week 4, patients who had previous experience with DFO were asked to indicate their preference for treatment (ICT received before the study, ICT received during the study, no preference, or no response) and the reason for that preference. At EOS, all patients were asked if they would be willing to continue using the ICT they had received during the study. All study analyses were performed in all patients who received at least 1 dose of study medication. Five hundred eighty-six patients (304 females, 282 males; age range, 2-53 years) received treatment with DFO (n = 290) or deferasirox (n = 296). Significantly more patients treated with deferasirox reported being very satisfied or satisfied with treatment compared with those treated with DFO (week 4: 92.0% vs 50.4%, respectively; week 24: 89.6% vs 44.0%; EOS: 85.1% vs 38.7%; all, P < 0.001). At the same time points, the majority of those treated with deferasirox reported that treatment was very convenient or convenient compared with those treated with DFO (95.5% vs 21.3%, 91.7% vs 17.4%, and 92.7% vs 11.3%, respectively; all, P < 0.001). Among patients who had previously taken DFO and were randomized to receive deferasirox during the study, 96.9% reported a preference for deferasirox over DFO. At EOS, the proportion of patients indicating a willingness to continue study therapy was significantly greater in those receiving deferasirox than in those receiving DFO (85.8% vs 13.8%; P < 0.001). In this study, patient-reported satisfaction and convenience were significantly higher for the once-daily, oral ICT deferasirox than for DFO infusions. Among patients who had received DFO before the study, the majority indicated a preference for deferasirox over DFO. Most patients receiving deferasirox indicated that they would be willing to continue taking it. These results suggest that deferasirox had a positive impact on patients' daily lives.

Complex tibial fractures are associated with lower social classes and predict early exit from employment and worse patient-reported QOL: a prospective observational study of 46 complex tibial fractures treated with a ring fixator.

PubMed

Elsoe, Rasmus; Larsen, Peter; Petruskevicius, Juozas; Kold, Søren

2018-04-01

The long-term outcomes following complex fractures of the tibia are reported to carry a risk of knee pain, malalignment, articular injury and post-traumatic osteoarthritis. The main objective of this study was to account for the patient-reported quality of life (QOL) 12 months after ring fixator removal in patients with a complex tibial fracture. Secondary objectives included a review of the socio-economic characteristics of the patient group and the rate of return to work in the study period. A prospective follow-up study was conducted of 60 patients with complex fractures of the tibia treated with ring external fixation. Patient-reported outcomes, radiological outcomes and socio-economic status including employment status of the patients were obtained 12 months after frame removal. Forty-six patients completed the assessment 12 months after frame removal (77%). The mean age of the patient at the time of fracture was 54.6 years (range 31-86). There were 19 males and 27 females. At 12 months after frame removal, the mean EQ5D-5L index was 0.66 (CI 0.60-0.72). The mean EQ5D-5L VAS was 69 (CI 61-76). When this was compared to the established reference population from Denmark, the study population showed a significantly worse EQ5D-5L index. The majority of patients (87%) were in the lower social classes suggesting a higher degree of social deprivation in the study population. Twenty-seven per cent of patients who were employed prior to injury had returned to employment at approximately 19 months following fracture. The onset of post-traumatic osteoarthritis was present in the knee joint in 29% of patients following a proximal intra-articular fracture, whereas osteoarthritis was present at the ankle joint in 35% of patients following a distal intra-articular fracture 12 months after frame removal. This study indicates that at 12 months after frame removal there are poorer patient-reported QOL as when compared to reference populations. Furthermore, this study suggests that complex tibial fractures are associated with lower social classes and that only 27% of patients in this sample, who prior to injury were employed, had returned to employment at approximately 19 months after the injury.

Prevalence and Consistency in Surgical Outcome Reporting for Femoroacetabular Impingement Syndrome: A Scoping Review.

PubMed

Reiman, Michael P; Peters, Scott; Sylvain, Jonathan; Hagymasi, Seth; Ayeni, Olufemi R

2018-04-01

The purposes of this review were (1) to collate and synthesize research studies reporting any outcome measure on both open and arthroscopic surgical treatment of femoroacetabular impingement (FAI) syndrome and (2) to report the prevalence and consistency of outcomes across the included studies. A computer-assisted literature search of the MEDLINE, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and Embase databases was conducted using keywords related to FAI syndrome and both open and arthroscopic surgical outcomes, resulting in 2,614 studies, with 163 studies involving 14,824 subjects meeting the inclusion criteria. Two authors independently reviewed study inclusion and data extraction with independent verification. The prevalence of reported outcomes was calculated and verified by separate authors. Between 2004 and 2016, there has been a 2,600% increase in the publication of surgical outcome studies. Patients had a mean duration of symptoms of 27.7 ± 21.5 months before surgery. Arthroscopy was the surgical treatment used in 71% of studies. The mean final follow-up period after surgery was 32.2 ± 17.3 months. Follow-up time frames were reported in 78% of studies. Ten different patient-reported outcome measures were reported. The alpha angle was reported to be measured 42% less frequently as a surgical outcome than as a surgical indication. Surgical complications were addressed in only 53% of studies and failures in 69%. Labral pathology (91% of studies reporting) and chondral pathology (61%) were the primary coexisting pathologies reported. Clinical signs, as defined by the Warwick Agreement on FAI syndrome, were reported in fewer than 25% of studies. Most FAI syndrome patients have longstanding pain and potential coexisting pathology. Patient-reported outcome measures and diagnostic imaging are the most frequently reported outcomes. Measures of hip strength and range of motion are under-reported. It is unclear whether the inconsistency in reporting is because of lack of measurement or lack of reporting of specific outcomes in these studies. Current surgical outcomes are limited to mid-term surgical follow-up time frames and inconsistent outcome reporting. Level IV, systematic review of Level I through IV studies. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

The reproductive potential of patients with Mayer-Rokitansky-Küster-Hauser syndrome using gestational surrogacy: a systematic review.

PubMed

Friedler, Shevach; Grin, Leonti; Liberti, Gad; Saar-Ryss, Buzhena; Rabinson, Yaakov; Meltzer, Semion

2016-01-01

Women with Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome may reproduce after uterine transplantation or IVF using a gestational surrogate. As uterine transplantation is still an experimental procedure, data on their clinical outcome using assisted reproduction techniques are imperative to allow evidence-based counselling. For this purpose, a systematic non-restricted electronic literature search was conducted. The 14 studies included in this review were published between 1988 and 2011. From a cohort of 140 patients with MRKH syndrome, mostly from the the USA and Israel, only four studies contained data on more than 10 patients; the others were case reports or small series. In the studies reviewed, 125 patients underwent 369 cycles of IVF with gestational surrogacy, and delivered 71 newborns. The reporting of outcome of patients with MRKH syndrome undergoing assisted reproduction techniques in the available literature is less than optimal and is characterized by bias of publication, inconsistent reports, including few patients, treated over a long time span, and lacking systematic reports from large IVF centres. None of the national registries contain specific outcome data on patients with MRKH syndrome. The paucity of data limits the possibility to draw firm conclusions but substantiates the need for a systematic multicentre reporting system. Copyright © 2015 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

CBT for Pediatric Migraine: A Qualitative Study of Patient and Parent Experience.

PubMed

Kroon Van Diest, Ashley M; Ernst, Michelle M; Vaughn, Lisa; Slater, Shalonda; Powers, Scott W

2018-03-08

The goal of this study was to determine which cognitive behavioral therapy (CBT-HA) treatment components pediatric headache patient stakeholders would report to be most helpful and essential to reducing headache frequency and related disability to develop a streamlined, less burdensome treatment package that would be more accessible to patients and families. Pediatric migraine is a prevalent and disabling condition. CBT-HA has been shown to reduce headache frequency and related disability, but may not be readily available or accepted by many migraine sufferers due to treatment burden entailed. Research is needed to determine systematic ways of reducing barriers to CBT-HA. Qualitative interviews were conducted with 10 patients and 9 of their parents who had undergone CBT-HA. Interviews were analyzed using an inductive thematic analysis approach based upon modified grounded theory. Patients were 13-17.5 years of age (M = 15.4, SD = 1.63) and had undergone CBT-HA ∼1-2 years prior to participating in the study. Overall, patients and their parents reported that CBT-HA was helpful in reducing headache frequency and related disability. Although patients provided mixed reports on the effectiveness of different CBT-HA skills, the majority of patients indicated that the mind and body relaxation skills of CBT-HA (deep breathing, progressive muscle relaxation, and activity pacing in particular) were the most helpful and most frequently used skills. Patients and parents also generally reported that treatment was easy to learn, and noted at least some aspect of treatment was enjoyable. Results from these qualitative interviews indicate that mind and body CBT-HA relaxation skills emerged as popular and effective based on patient and parent report. Future research examining the effectiveness of streamlined pediatric migraine nonpharmacological interventions should include these patient-preferred skills. © 2018 American Headache Society.

Can patients manage toileting after reverse total shoulder arthroplasty? A systematic review.

PubMed

Rojas, Jorge; Joseph, Jacob; Liu, Bingli; Srikumaran, Uma; McFarland, Edward G

2018-03-23

A major concern for patients undergoing reverse total shoulder arthroplasty (RTSA) is managing toileting after surgery. The goals of this systematic review of RTSA studies were to determine the following: (1) the percentage of patients who can manage toileting, (2) their degree of difficulty with toileting, and (3) the percentage of patients who can manage toileting after bilateral versus unilateral RTSA. Medline, EMBASE, Google Scholar, and the Cochrane Central Register of Controlled Trials were searched for studies reporting the ability to manage toileting after RTSA. Six studies with at least 12 months of follow-up were included, yielding 183 patients (105 unilateral RTSA, 78 bilateral RTSA). We pooled patient data and calculated the weighted mean proportion of patients able to manage toileting, those who reported difficulty, and those able to manage toileting after unilateral versus bilateral RTSA. Statistical significance was set at P < 0.05. Most patients (92%; 95% confidence interval, 87-95%) were able to manage toileting after RTSA. Some degree of difficulty with toileting was reported for 20% of all shoulders. Almost all patients with bilateral RTSA were able to manage toileting with at least one arm (weighted mean proportion 97%; 95% confidence interval, 88-99%). There was no significant difference in the proportion of patients able to manage toileting after unilateral versus bilateral RTSA (P = 0.08). Only 3% of all papers published on the clinical results of RTSA by June 2017 reported upon toileting after the procedure. With the available evidence, most patients were able to manage toileting after RTSA, although one-fifth reported some degree of difficulty. Ability to manage toileting was similar after unilateral versus bilateral RTSA. In the future, this variable should be a standard question after shoulder arthroplasty. IV.

Safety incidents involving confused and forgetful older patients in a specialised care setting--analysis of the safety incidents reported to the HaiPro reporting system.

PubMed

Kinnunen-Luovi, Kaisa; Saarnio, Reetta; Isola, Arja

2014-09-01

To describe the safety incidents involving confused and forgetful older patients in a specialised care setting entered in the HaiPro reporting system. About 10% of patients experience a safety incident during hospitalisation, which causes or could cause them harm. The possibility of a safety incident during hospitalisation increases significantly with age. A mild or moderate memory disorder and acute confusion are often present in the safety incidents originating with an older patient. The design of the study was action research with this study using findings from one of the first-phase studies, which included qualitative and quantitative analysed data. Data were collected from the reporting system for safety incidents (HaiPro) in a university hospital in Finland. There were 672 reported safety incidents from four acute medical wards during the years 2009-2011, which were scrutinised. Seventy-five of them were linked to a confused patient and were analysed. The majority of the safety incidents analysed involved patient-related accidents. In addition to challenging behaviour, contributing factors included ward routines, shortage of nursing staff, environmental factors and staff knowledge and skills. Nurses tried to secure the patient safety in many different ways, but the modes of actions were insufficient. Nursing staff need evidence-based information on how to assess the cognitive status of a confused patient and how to encounter such patients. The number of nursing staff and ward routines should be examined critically and put in proportion to the care intensity demands caused by the patient's confused state. The findings can be used as a starting point in the prevention of safety incidents and in improving the care of older patients. © 2013 John Wiley & Sons Ltd.

AN EXPLORATORY STUDY INVESTIGATING THE EFFECTS OF A TREATMENT MANUAL FOR VIDEO GAME ADDICTION.

PubMed

Pallesen, Ståle; Lorvik, Ingjerd Meen; Bu, Eli Hellandsjø; Molde, Helge

2015-10-01

This study investigated the effects of a manualized therapy for video game addiction in 12 males, ages 14-18 yr. The manual was based on cognitive-behavioral therapy, short-term strategic family therapy, solution-focused therapy, and motivational interviewing. Treatment response was reported by the patients, their mothers, and the therapists. The patients reported moderate (but statistically non-significant) improvement from pre- to post-treatment. The mothers, however, reported large effects and statistically significant improvement from pre- to post-treatment. The therapists reported marked or moderate treatment response in six of the 12 patients. The ratings of change by mothers converged well with the views of change of both the patients and therapists, whereas the convergence of views on change between the two latter sources was far lower.

Total Joint Arthroplasty Patients' Education on Financial Issues and Its Connection to Reported Out-of-Pocket Costs-A European Study.

PubMed

Copanitsanou, Panagiota; Valkeapää, Kirsi; Cabrera, Esther; Katajisto, Jouko; Leino-Kilpi, Helena; Sigurdardottir, Arun K; Unosson, Mitra; Zabalegui, Adelaida; Lemonidou, Chryssoula

2017-04-01

Total joint arthroplasty is accompanied by significant costs. In nursing, patient education on financial issues is considered important. Our purpose was to examine the possible association between the arthroplasty patients' financial knowledge and their out-of-pocket costs. Descriptive correlational study in five European countries. Patient data were collected preoperatively and at 6 months postoperatively, with structured, self-administered instruments, regarding their expected and received financial knowledge and out-of-pocket costs. There were 1,288 patients preoperatively, and 352 at 6 months. Patients' financial knowledge expectations were higher than knowledge received. Patients with high financial knowledge expectations and lack of fulfillment of these expectations had lowest costs. There is need to establish programs for improving the financial knowledge of patients. Patients with fulfilled expectations reported higher costs and may have followed and reported their costs in a more precise way. In the future, this association needs multimethod research. © 2016 Wiley Periodicals, Inc.

Understanding "revolving door" patients in general practice: a qualitative study.

PubMed

Williamson, Andrea E; Mullen, Kenneth; Wilson, Philip

2014-02-13

'Revolving door' patients in general practice are repeatedly removed from general practitioners' (GP) lists. This paper reports a qualitative portion of the first mixed methods study of these marginalised patients. We conducted qualitative semi-structured interviews with six practitioner services staff and six GPs in Scotland, utilizing Charmazian grounded theory to characterise 'revolving door' patients and their impact from professionals' perspectives. 'Revolving door' patients were reported as having three necessary characteristics; they had unreasonable expectations, exhibited inappropriate behaviours and had unmet health needs. A range of boundary breaches were reported too when 'revolving door' patients interacted with NHS staff. We utilise the 'sensitising concepts' of legitimacy by drawing on literature about 'good and bad' patients and 'dirty work designations.' We relate these to the core work of general practice and explore the role that medical and moral schemas have in how health service professionals understand and work with 'revolving door' patients. We suggest this may have wider relevance for the problem doctor patient relationship literature.

Cognitive functioning in psychiatric disorders following deep brain stimulation.

PubMed

Bergfeld, Isidoor O; Mantione, Mariska; Hoogendoorn, Mechteld L C; Denys, Damiaan

2013-07-01

Deep brain stimulation (DBS) is routinely used as a treatment for treatment-refractory Parkinson's disease and has recently been proposed for psychiatric disorders such as Tourette syndrome (TS), obsessive-compulsive disorder (OCD) and major depressive disorder (MDD). Although cognitive deterioration has repeatedly been shown in patients with Parkinson's disease following DBS, the impact of DBS on cognitive functioning in psychiatric patients has not yet been reviewed. Reviewing the available literature on cognitive functioning following DBS in psychiatric patients. A systematic literature search in PubMed, EMBASE and Web of Science, last updated in September 2012, found 1470 papers. Abstracts were scrutinized and 26 studies examining cognitive functioning of psychiatric patients following DBS were included on basis of predetermined inclusion criteria. Twenty-six studies reported cognitive functioning of 130 psychiatric patients following DBS (37 TS patients, 56 OCD patients, 28 MDD patients, 6 patients with Alzheimer's disease, and 3 patients with other disorders). None of the studies reported substantial cognitive decline following DBS. On the contrary, 13 studies reported cognitive improvement following DBS. Preliminary results suggest that DBS in psychiatric disorders does not lead to cognitive decline. In selected cases cognitive functioning was improved following DBS. However, cognitive improvement cannot be conclusively attributed to DBS since studies are hampered by serious limitations. We discuss the outcomes in light of these limitations and offer suggestions for future work. Copyright © 2013 Elsevier Inc. All rights reserved.

The prognosis of self-reported paresthesia and weakness in disc-related sciatica.

PubMed

Grøvle, L; Haugen, A J; Natvig, B; Brox, J I; Grotle, M

2013-11-01

To explore how patients with sciatica rate the 'bothersomeness' of paresthesia (tingling and numbness) and weakness as compared with leg pain during 2 years of follow-up. Observational cohort study including 380 patients with sciatica and lumbar disc herniation referred to secondary care. Using the Sciatica Bothersomeness Index paresthesia, weakness and leg pain were rated on a scale from 0 to 6. A symptom score of 4-6 was defined as bothersome. Along with leg pain, the bothersomeness of paresthesia and weakness both improved during follow-up. Those who received surgery (n = 121) reported larger improvements in both symptoms than did those who were treated without surgery. At 2 years, 18.2% of the patients reported bothersome paresthesia, 16.6% reported bothersome leg pain, and 11.5% reported bothersome weakness. Among patients with no or little leg pain, 6.7% reported bothersome paresthesia and 5.1% bothersome weakness. During 2 years of follow-up, patients considered paresthesia more bothersome than weakness. At 2 years, the percentage of patients who reported bothersome paresthesia was similar to the percentage who reported bothersome leg pain. Based on patients' self-report, paresthesia and weakness are relevant aspects of disc-related sciatica.

Comparative Effectiveness of Propranolol and Botulinum for the Treatment of Essential Voice Tremor

PubMed Central

Justicz, Natalie; Hapner, Edie R.; Josephs, Joshua S.; Boone, Benjamin C.; Jinnah, Hyder A.; Johns, Michael M.

2016-01-01

Objectives/Hypothesis To assess the comparative effectiveness of botulinum toxin and propranolol in patients with essential vocal tremor (EVT). Study Design Individual prospective cohort study. Methods Study patients were recruited at the Emory Voice Center from patients seeking treatment for EVT. Exclusion criteria included current β-blocker treatment, spasmodic dysphonia, or other disease that prevented the use of propranolol therapy. A 10-week washout period from prior botulinum toxin treatment occurred before enrollment. Patients were assessed via the Voice-Related Quality-Of-Life (VRQOL) questionnaire, Quality of life in Essential Tremor questionnaire, and blinded perceptual voice assessment. These assessments were made at baseline voice 2 weeks after propranolol therapy and 4 weeks after botulinum toxin injection. Results Eighteen patients were enrolled. After 2 to 4 weeks of propranolol therapy (with a maximum dosage of 60 mg to 90 mg per day), patients report an average ΔVRQOL of 9.31. Six patients report significant VRQOL improvement >10, with the rest reporting changes between −7.5 and 7.5. Fifteen patients were followed for at least 4 weeks after botulinum toxin injection, reporting an average improvement in scaled VRQOL of 22.00. Blinded perceptual voice assessment demonstrates an improvement in overall severity of tremor with botulinum toxin. Conclusions In some patients with EVT, propranolol led to significant vocal improvement with no major side effects. Although botulinum toxin remains the gold-standard therapy for patients with EVT, propranolol represents a possible alternative or adjuvant therapy for certain patients. PMID:26198384

The Association of Proxy Care Engagement with Proxy Reports of Patient Experience and Quality of Life.

PubMed

Roydhouse, Jessica K; Gutman, Roee; Keating, Nancy L; Mor, Vincent; Wilson, Ira B

2018-05-27

To assess the association of proxy-specific covariates with proxy-reported patient cancer care experience, quality rating, and quality of life. Secondary analysis of data from the Cancer Care Outcomes Research and Surveillance (CanCORS) study. Cross-sectional observational study. The respondents were proxies for patients with incident colorectal or lung cancer. Analyses used linear regression models and adjusted for patient sociodemographic and clinical characteristics. Outcomes included patients' experiences with medical care, nursing care, and care coordination, overall quality ratings, and physical and mental health, all scored on 0-100 scales (0 = worst, 100 = best). Independent variables included the proxy's relationship with the patient and engagement in patient care. Of 1,011 proxies, most were the patient's spouse (50 percent) or child (36 percent). Although most proxies (66 percent) always attended medical visits, 3 percent reported never attending. After adjustment, on average children reported worse experiences and poorer quality care than spouses (4-9 points lower across outcomes). Proxies who never attended medical visits reported significantly worse medical care (-11 points, 95 percent CI = -18 to -3) and care coordination (-13 points, 95 percent CI = -20 to -6). Collecting data on proxy engagement in care is warranted if proxy responses are used. © Health Research and Educational Trust.

Minimally invasive therapy for gynaecological symptoms related to a niche in the caesarean scar: a systematic review.

PubMed

van der Voet, L F; Vervoort, A J; Veersema, S; BijdeVaate, A J; Brölmann, H A M; Huirne, J A F

2014-01-01

Various therapies are currently used to treat symptoms related to the niche (an anechoic area) in the caesarean scar, in particular to treat abnormal uterine bleeding (AUB). To systematically review the available literature reporting on the effect of various therapies on niche-related symptoms. A systematic search of MEDLINE, Embase, Cochrane, trial registers and congress abstracts from AAGL and ESGE was performed. Articles reporting on the effectiveness of therapies other than hysterectomy in women with niche-related symptoms were included. Studies were included if they reported one of the following outcomes: effect on AUB, pain relief, sexual function, quality of life (QOL), and surgical, anatomic, fertility, or pregnancy outcome. Two authors independently selected the articles to be included. The Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines were followed. A standardised checklist was used to score the methodological quality of the included studies. Twelve studies were included, reporting on hysteroscopic niche resection (eight studies, 384 patients), laparoscopic repair (one study, 13 patients), (laparoscopic assisted) vaginal repair (two studies, 47 patients), and oral contraceptives (OCs) (one study, 11 patients). Reported AUB improved in the vast majority of the patients after these interventions, ranging from 87 to 100%. The rate of complications was low. Pregnancies were reported after therapy; however, sample sizes and follow-up were insufficient to study fertility or pregnancy outcome. The methodological quality of the selected papers was considered to be moderate to poor, and was therefore insufficient to make solid conclusions. More evidence is needed before (surgical) niche interventions are implemented in daily practice. © 2013 Royal College of Obstetricians and Gynaecologists.

The relationship between childhood trauma and adult psychosis in a UK Early Intervention Service: results of a retrospective case note study.

PubMed

Reeder, Francesca D; Husain, Nusrat; Rhouma, Abdul; Haddad, Peter M; Munshi, Tariq; Naeem, Farooq; Khachatryan, Davit; Chaudhry, Imran B

2017-01-01

There is evidence that childhood trauma is a risk factor for the development of psychosis and it is recommended that childhood trauma is inquired about in all patients presenting with psychosis. This study aimed to determine the prevalence of childhood trauma in patients in the UK Early Intervention Service based on a case note review. This is a retrospective case note study of 296 patients in an UK Early Intervention Service. Trauma history obtained on service entry was reviewed and trauma experienced categorized. Results were analyzed using crosstab and frequency analysis. The mean age of the sample was 24 years, 70% were male, 66% were White, and 23% Asian (ethnicity not documented in 11% of the sample). Approximately 60% of patients reported childhood trauma, 21% reported no childhood trauma, and data were not recorded for the remaining 19%. Among those reporting trauma, the prevalence of most frequently reported traumas were: severe or repeated disruption (21%), parental mental illness (19%), bullying (18%), absence of a parent (13%), and 'other' trauma (24%) - the majority of which were victimization events. Sixty-six percent of those reporting trauma had experienced multiple forms of trauma. A high prevalence of childhood trauma (particularly trauma related to the home environment or family unit) was reported. This is consistent with other studies reporting on trauma and psychosis. The main weakness of the study is a lack of a control group reporting experience of childhood trauma in those without psychosis. Guidelines recommend that all patients with psychosis are asked about childhood trauma; but in 19% of our sample there was no documentation that this had been done indicating the need for improvement in assessment.

Changes in Patient-Reported Alcohol-Related Advice Following Veterans Health Administration Implementation of Brief Alcohol Interventions.

PubMed

Chavez, Laura J; Williams, Emily C; Lapham, Gwen T; Rubinsky, Anna D; Kivlahan, Daniel R; Bradley, Katharine A

2016-05-01

Brief alcohol interventions are recommended for primary care patients who screen positive for alcohol misuse, but implementation is challenging. The U.S. Veterans Health Administration (Veterans Affairs [VA]) implemented brief interventions for patients with alcohol misuse in 2008, and rates of brief interventions documented in the electronic medical record increased from 24% to 78% (2008-2011). This study examined whether an independent measure of brief interventions-patient-reported alcohol-related advice-also increased among VA outpatients who screened positive for alcohol misuse on a mailed survey. This retrospective cross-sectional study included VA outpatient respondents to the VA's Survey of Healthcare Experiences of Patients (SHEP; 2007-2011) who reported past-year alcohol use and answered a question about alcohol-related advice. Alcohol-related advice was defined as a report of past-year advice from a VA clinician to abstain from or reduce drinking. The adjusted prevalence of alcoholrelated advice among patients who screened positive for alcohol misuse (SHEP AUDIT-C ≥ 5) was estimated for each year. Among patients with alcohol misuse (n = 61,843), the adjusted prevalence of alcohol-related advice increased from 40.4% (95% CI [39.3%, 41.5%]) in 2007 to 55.5% (95% CI [53.3%, 57.8%]) in 2011. Rates of alcoholrelated advice increased significantly each year except the last. The VA's efforts to implement brief interventions were associated with increased patient-reported alcohol-related advice over time, with a majority of patients with alcohol misuse reporting its receipt. Other systems considering similar approaches to implementation may benefit from collecting patient-reported measures of brief interventions for an additional perspective on implementation.

Functional Outcome and Graft Retention in Patients With Septic Arthritis After Anterior Cruciate Ligament Reconstruction: A Systematic Review.

PubMed

Makhni, Eric C; Steinhaus, Michael E; Mehran, Nima; Schulz, Brian S; Ahmad, Christopher S

2015-07-01

To provide a comprehensive review of clinical and functional outcomes after treatment for septic arthritis after anterior cruciate ligament reconstruction. A systematic review of the literature was performed. Two reviewers assessed and confirmed the methodologic quality of each study. Studies that met the inclusion criteria were assessed for pertinent data, and when available, similar outcomes were combined to generate frequency-weighted means. Nineteen studies met the inclusion and exclusion criteria for this review, reporting on a total of 203 infected knees. The mean age was 27.5 years and the mean length of follow-up was 44.2 months, with male patients comprising 88% of the population. Hamstring and bone-patellar tendon-bone autografts were used in 63% and 33% of patients, respectively, with 78% of patients retaining their grafts. The studies reported mean flexion and extension deficits of 5.8° and 1.0°, respectively, and laxity testing showed a mean difference of 1.9 mm. The studies reported mean Lysholm, International Knee Documentation Committee, and Tegner scores of 82.1, 68.2, and 5.6, respectively. Of the patients, 83% reported an ability to return to activities of daily living whereas 67% reported a return to their preinjury level of athletics. Evidence of new degenerative changes was seen in 22% of patients. Septic arthritis after anterior cruciate ligament reconstruction remains a very infrequent event, affecting 0.5% of patients. On average, outcomes in these patients are comparable with those in patients in whom infection does not develop, including postoperative range of motion, residual instability, Lysholm scores, and return to preinjury level of activity. These patients do exhibit decreased International Knee Documentation Committee scores compared with patients without septic arthritis, however. The impact of this differential is not clear, but this scoring difference suggests that septic arthritis may be associated with more severe symptoms and reduced functional outcomes. In addition, there is limited evidence suggesting that septic arthritis leads to early degenerative changes found on imaging. Level IV, systematic review of Level III and IV studies. Copyright © 2015 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Understanding the suffering of a patient with an illness: signs, context and strategies.

PubMed

Hueso Montoro, César; Siles González, José; Amezcua, Manuel; Bonill de Las Nieves, Candela; Pastor Montero, Sonia; Celdrán Mañas, Miriam

2012-01-01

The aim of this study is to understand the suffering of a patient with an illness, by using a secondary research method, that is, a qualitative meta-study. The primary data source of the meta-study includes "biographical reports". This project is based on a case study, in which the first-hand experiences of a patient with an illness were collected. The findings of the reports were compiled using the Archivos de la Memoria collection of the Index Foundation (Granada, Spain) and journals specialized in editing these materials. A selection of 20 biographical reports was targeted. The results of the meta-study show that suffering is a multidimensional process within a framework of ambiguous feelings. The suffering involves family and social network participation. Patients develop a range of strategies to overcome the illness. One of the effects is the fear of illness relapse or worsening.

Everyday Functioning in Huntington's Disease: A Laboratory-Based Study of Financial Management Capacity.

PubMed

Sheppard, David P; Pirogovsky-Turk, Eva; Woods, Steven Paul; Holden, Heather M; Nicoll, Diane R; Filoteo, J Vincent; Corey-Bloom, Jody; Gilbert, Paul E

2017-01-01

One important limitation of prior studies examining functional decline in Huntington's disease (HD) has been the reliance on self-reported measures of ability. Since report-based methods can be biased by lack of insight, depression, and cognitive impairment, contrasting self-reported ability with measures that assess capacity may lead to a more comprehensive estimation of real-world functioning. The present study examined self-reported ability to perform instrumental activities of daily living (iADLs) and performance-based financial management capacity in 20 patients diagnosed with mild-moderate Huntington's disease (HD) and 20 demographically similar healthy adults. HD patients reported significantly greater declines in their ability to manage finances. On the capacity measure of financial management, HD patients performed significantly below healthy adults. Additionally, in the HD group there were no significant correlations between self-reported ability and capacity measures of financial management. HD patients endorsed declines in global iADL ability and exhibited deficits in functional capacity when performing a financial management task. Capacity measures may aid in assessing the extent to which HD patients accurately estimate real-world iADL performance, and the present findings suggest that such measures of capacity may be related to the cognitive, but not motor or affective, symptoms of HD.

Self-Reported Employment Status and Social Participation After Successful Kidney Transplantation.

PubMed

Parajuli, Sandesh; Singh, Jagmeet; Sandal, Shaifali; Liebman, Scott E; Demme, Richard A

2016-03-01

Kidney transplantation (KTX) is considered the treatment of choice for most individuals with end-stage kidney disease. The purpose of this study was to assess the employment status and social participation after successful KTX. This was a retrospective cross-sectional study. Eligible participants were patients who received a transplant ≥1 year ago and who were previously on hemodialysis (HD) for ≥1 year. Two hundred individuals participated in this study. A significant number (93.5%) of patients reported they were working prior to HD versus 35% while on HD. Only 14% reported receiving disability benefits prior to HD versus 75% receiving disability while on HD. Comparing transplant recipients with pre-HD patients, 35.5% versus 93.5% reported working, and 74.5% versus 14% reported receiving disability benefits, respectively. After transplant, patients were more likely to join recreational clubs, travel frequently, and participate in recreational/religious activities and social events than when they were on HD. Posttransplant, these individuals are more likely to participate in social and leisure activities, but the majority did not resume employment and continued to receive disability payments. Future studies could explore barriers to employment in patients who underwent successful transplantation and the causes and factors as to why these individuals continue to receive disability benefits. © 2016, NATCO.

Type D personality and health status in cardiovascular disease populations: a meta-analysis of prospective studies.

PubMed

Versteeg, Henneke; Spek, Viola; Pedersen, Susanne S; Denollet, Johan

2012-12-01

Knowledge of the factors associated with individual differences in patient-reported outcomes is essential to identify high-risk patients and improve secondary prevention. In this meta-analysis, we examined the association between Type D personality and the individual differences in patient-reported physical and mental health status among cardiovascular patients. A computerized search of the literature through PUBMED and PsychINFO (from 1995 to May 2011) was performed and prospective studies were selected that analysed the association between Type D personality and health status in cardiovascular patients. Two separate meta-analyses were performed for the association of Type D personality with physical and mental health status, respectively. Of all identified studies, ten studies met the selection criteria. The meta-analyses showed that Type D was associated with a two-fold increased odds for impaired physical health status (3035 patients, OR 1.94, 95% CI 1.49-2.52) and a 2.5-fold increased odds for impaired mental health status (2213 patients, OR 2.55, 95% CI 1.57-4.16). There was no significant heterogeneity between the studies on physical health status (Q = 12.78; p = 0.17; I(2 )= 29.59), but there was between those on mental health status (Q = 21.91; p = 0.003; I(2 )= 68.04). Subgroup analyses showed that the association between Type D and mental health status decreased yet remained significant when adjusting for baseline health status. Type D personality was shown to be an independent correlate of impaired patient-reported physical and mental health status in various cardiovascular patient groups. Clinicians should be aware of the association between chronic psychological distress and poor patient-reported outcomes.

Effects of patient safety culture interventions on incident reporting in general practice: a cluster randomised trial

PubMed Central

Verbakel, Natasha J; Langelaan, Maaike; Verheij, Theo JM; Wagner, Cordula; Zwart, Dorien LM

2015-01-01

Background A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting A three-arm cluster randomised trial was conducted in a mixed method study, studying the effect of administering a patient safety culture questionnaire (intervention I), the questionnaire complemented with a practice-based workshop (intervention II) and no intervention (control) in 30 general practices in the Netherlands. Method The primary outcome, the number of reported incidents, was measured with a questionnaire at baseline and a year after. Analysis was performed using a negative binomial model. Secondary outcomes were quality and safety indicators and safety culture. Mixed effects linear regression was used to analyse the culture questionnaires. Results The number of incidents increased in both intervention groups, to 82 and 224 in intervention I and II respectively. Adjusted for baseline number of incidents, practice size and accreditation status, the study showed that practices that additionally participated in the workshop reported 42 (95% confidence interval [CI] = 9.81 to 177.50) times more incidents compared to the control group. Practices that only completed the questionnaire reported 5 (95% CI = 1.17 to 25.49) times more incidents. There were no statistically significant differences in staff perception of patient safety culture at follow-up between the three study groups. Conclusion Educating staff and facilitating discussion about patient safety culture in their own practice leads to increased reporting of incidents. It is beneficial to invest in a team-wise effort to improve patient safety. PMID:25918337

Effects of patient safety culture interventions on incident reporting in general practice: a cluster randomised trial.

PubMed

Verbakel, Natasha J; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M

2015-05-01

A constructive safety culture is essential for the successful implementation of patient safety improvements. To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. A three-arm cluster randomised trial was conducted in a mixed method study, studying the effect of administering a patient safety culture questionnaire (intervention I), the questionnaire complemented with a practice-based workshop (intervention II) and no intervention (control) in 30 general practices in the Netherlands. The primary outcome, the number of reported incidents, was measured with a questionnaire at baseline and a year after. Analysis was performed using a negative binomial model. Secondary outcomes were quality and safety indicators and safety culture. Mixed effects linear regression was used to analyse the culture questionnaires. The number of incidents increased in both intervention groups, to 82 and 224 in intervention I and II respectively. Adjusted for baseline number of incidents, practice size and accreditation status, the study showed that practices that additionally participated in the workshop reported 42 (95% confidence interval [CI] = 9.81 to 177.50) times more incidents compared to the control group. Practices that only completed the questionnaire reported 5 (95% CI = 1.17 to 25.49) times more incidents. There were no statistically significant differences in staff perception of patient safety culture at follow-up between the three study groups. Educating staff and facilitating discussion about patient safety culture in their own practice leads to increased reporting of incidents. It is beneficial to invest in a team-wise effort to improve patient safety. © British Journal of General Practice 2015.

Characteristics of methadone maintenance treatment patients prescribed opioid analgesics

PubMed Central

Glenn, Matthew C.; Sohler, Nancy L.; Starrels, Joanna L.; Maradiaga, Jeronimo; Jost, John J.; Arnsten, Julia H.; Cunningham, Chinazo O.

2016-01-01

Background Opioid analgesic use and disorders have dramatically increased among the general American population and those receiving methadone maintenance treatment (MMT). Most research among MMT patients focuses on opioid analgesics misuse or disorders; few studies focus on MMT patients prescribed opioid analgesics. We describe demographic, clinical, and substance use characteristics of MMT patients prescribed opioid analgesics and compare them to MMT patients not prescribed opioid analgesics. Methods We conducted a cross-sectional secondary data analysis using screening interviews from a parent study. From 2012–2015, we recruited adults from 3 MMT Bronx clinics. Questionnaire data included: patterns of opioid analgesic use, substance use, comorbid illnesses, and demographic characteristics. Our main dependent variable was patients’ report of currently taking prescribed opioid analgesics. To compare characteristics between MMT patients prescribed and not prescribed opioid analgesics, we conducted chi-squared tests, t-tests, and Mann-Whitney U tests. Results Of 611 MMT patients, most reported chronic pain (62.0%), HCV infection (52.1%), and currently using illicit substances (64.2%). Of the 29.8% who reported currently taking prescribed opioid analgesics, most misused their opioid analgesics (57.5%). Patients prescribed (versus not prescribed) opioid analgesics were more likely to report HIV infection (aOR=1.6, 95% CI: 1.1–2.3) and chronic pain (aOR=7.6, 95% CI: 4.6–12.6). Conclusion Among MMT patients primarily in three Bronx clinics, nearly one-third reported taking prescribed opioid analgesics. Compared to patients not prescribed opioid analgesics, those prescribed opioid analgesics were more likely to report chronic pain and HIV infection. However, between these patients, there was no difference in illicit substance use. These findings highlight the complexity of addressing chronic pain in MMT patients. PMID:26731299

Outside CT imaging among emergency department transfer patients.

PubMed

Sung, Jeffrey C; Sodickson, Aaron; Ledbetter, Stephen

2009-09-01

The aim of this study was to characterize the quantity and types of outside computed tomographic (CT) examinations submitted for reinterpretation among emergency department (ED) transfers to a tertiary care, level I trauma, academic medical center and the frequency of and reasons for repeat imaging. Reinterpretation requests for outside CT studies accompanying ED transfer patients over a 4-month period were prospectively audited. Clinicians completed forms specifying type of CT study, outside report availability, interpretational discrepancies, repeat imaging requests, and reasons for repeat imaging. A total of 425 CT studies were reviewed among 255 transfer patients, with a mean of 2.8 examinations (range, 0-16) on 1.7 patients (range, 0-8) per day. The patients' mean age was 59 years, and 57% were male. The clinicians reported no outside verbal or written reports for 16% of patients. Interpretational discrepancies were noted in 12% of those with outside reports. Repeat scans might have been avoided in as many as 25% of rescanned patients (35% of repeat examinations) because they were performed solely for imaging or information technology reasons (inadequate imaging, compact disc inoperability, or unavailable images within the hospital's picture archiving and communication system). Rescanned trauma patients in particular had a high per patient rate (32%) of potentially avoidable reasons, with a lower rate (11%) in nontrauma patients. Outside CT imaging in ED transfers adds workload and resource requirements for receiving institutions. A communication gap exists between transferring and receiving institutions, and interpretational discrepancies are common. Process improvement measures are suggested that might reduce the substantial rates of potentially avoidable reimaging.

Chiropractic care of children from birth to adolescence and classification of reported conditions: an internet cross-sectional survey of 956 European chiropractors.

PubMed

Marchand, Aurélie M

2012-06-01

Few studies have addressed the practice of chiropractic care of children in Europe. No systematic classification of conditions currently exists in chiropractic pediatrics. The objective of this study was to investigate characteristics of clinical chiropractic practice, including the age of pediatric patients, the number of reports of negative side effects (NSEs), the opinions of doctors of chiropractic on treatment options by patient age groups, the conditions seen and the number of treatment sessions delivered by conditions and by patient age. An Internet cross-sectional survey was conducted in 20 European countries with 4109 doctors of chiropractic invited to reply. The 19 national associations belonging to the European Chiropractic Union and the Danish Chiropractic Association were asked to participate. Respondents were asked to self-report characteristics of their practices. Of the 956 (23.3%) participating chiropractors, 921 reported 19821 pediatric patients per month. Children represented 8.1% of chiropractors' total patient load over the last year. A total of 557 (534 mild, 23 moderate, and 0 severe) negative (adverse) side effects were reported for an estimated incidence of 0.23%. On the given treatment statements, chiropractors reported varying agreement and disagreement rates based on patient age. The 8309 answers on conditions were grouped into skeletal (57.0%), neurologic (23.7%), gastrointestinal (12.4%), infection (3.5%), genitourinary (1.5%), immune (1.4%), and miscellaneous conditions (0.5%). The number of treatment sessions delivered varied according to the condition and the patient age. This study showed that European chiropractors are active in the care of pediatric patients. Reported conditions were mainly skeletal and neurologic complaints. In this survey, no severe NSEs were reported, and mild NSEs were infrequent. Copyright © 2012 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

Reporting of euthanasia and physician-assisted suicide in the Netherlands: descriptive study.

PubMed

Buiting, Hilde; van Delden, Johannes; Onwuteaka-Philpsen, Bregje; Rietjens, Judith; Rurup, Mette; van Tol, Donald; Gevers, Joseph; van der Maas, Paul; van der Heide, Agnes

2009-10-27

An important principle underlying the Dutch Euthanasia Act is physicians' responsibility to alleviate patients' suffering. The Dutch Act states that euthanasia and physician-assisted suicide are not punishable if the attending physician acts in accordance with criteria of due care. These criteria concern the patient's request, the patient's suffering (unbearable and hopeless), the information provided to the patient, the presence of reasonable alternatives, consultation of another physician and the applied method of ending life. To demonstrate their compliance, the Act requires physicians to report euthanasia to a review committee. We studied which arguments Dutch physicians use to substantiate their adherence to the criteria and which aspects attract review committees' attention. We examined 158 files of reported euthanasia and physician-assisted suicide cases that were approved by the review committees. We studied the physicians' reports and the verdicts of the review committees by using a checklist. Physicians reported that the patient's request had been well-considered because the patient was clear-headed (65%) and/or had repeated the request several times (23%). Unbearable suffering was often substantiated with physical symptoms (62%), function loss (33%), dependency (28%) or deterioration (15%). In 35%, physicians reported that there had been alternatives to relieve patients' suffering which were refused by the majority. The nature of the relationship with the consultant was sometimes unclear: the consultant was reported to have been an unknown colleague (39%), a known colleague (21%), otherwise (25%), or not clearly specified in the report (24%). Review committees relatively often scrutinized the consultation (41%) and the patient's (unbearable) suffering (32%); they had few questions about possible alternatives (1%). Dutch physicians substantiate their adherence to the criteria in a variable way with an emphasis on physical symptoms. The information they provide is in most cases sufficient to enable adequate review. Review committees' control seems to focus on (unbearable) suffering and on procedural issues.

Pilot Feasibility Study of an Oncology Financial Navigation Program.

PubMed

Shankaran, Veena; Leahy, Tony; Steelquist, Jordan; Watabayashi, Kate; Linden, Hannah; Ramsey, Scott; Schwartz, Naomi; Kreizenbeck, Karma; Nelson, Judy; Balch, Alan; Singleton, Erin; Gallagher, Kathleen; Overstreet, Karen

2018-02-01

Few studies have reported on interventions to alleviate financial toxicity in patients with cancer. We developed a financial navigation program in collaboration with our partners, Consumer Education and Training Services (CENTS) and Patient Advocate Foundation (PAF), to improve patient knowledge about treatment costs, provide financial counseling, and to help manage out-of-pocket expenses. We conducted a pilot study to assess the feasibility and impact of this program. Patients with cancer received a financial education course followed by monthly contact with a CENTS financial counselor and a PAF case manager for 6 months. We measured program adherence, self-reported financial burden and anxiety, program satisfaction, and type of assistance provided. Thirty-four patients (median age, 60.5 years) were consented (85% white and 50% commercially insured). Debt, income declines, and loans were reported by 55%, 55%, and 30% of patients, respectively. CENTS counselors assisted most often with budgeting, retirement planning, and medical bill questions. PAF case managers assisted with applications for appropriate insurance coverage, cost of living issues (eg, housing, transportation), and disability applications. High financial burden and anxiety about costs (4 or 5 on a Likert scale) were reported at baseline by 37% and 47% of patients, respectively. Anxiety about costs decreased over time in 33% of patients, whereas self-reported financial burden did not substantially change. Implementing an oncology financial navigation program is feasible, provides concrete assistance in navigating the cost of care, and mitigates anxiety about costs in a subset of patients. Future work will focus on measuring the program's impact on financial and clinical outcomes.

Second-opinion interpretations of neuroimaging studies by oncologic neuroradiologists can help reduce errors in cancer care.

PubMed

Hatzoglou, Vaios; Omuro, Antonio M; Haque, Sofia; Khakoo, Yasmin; Ganly, Ian; Oh, Jung Hun; Shukla-Dave, Amita; Fatovic, Robin; Gaal, Joshua; Holodny, Andrei I

2016-09-01

The purpose of this study was to investigate the utility and clinical impact of second-opinion interpretations of outside neuroimaging studies by oncologic neuroradiologists at a National Cancer Institute-designated cancer center. We performed a retrospective analysis of initial outside and second-opinion radiology reports from 300 computed tomography and magnetic resonance imaging studies and identified cases with discrepancies between the two reports. An adult neuro-oncologist, pediatric neuro-oncologist, and head and neck surgeon reviewed each pair of discrepant reports based on their area of expertise, patient age, and the type of study performed. The clinicians were blinded to the origin of each report and recorded whether the differences in the reports would have led to a change in patient management and/or disease staging. Histopathologic analysis, clinical assessment, and/or minimum 3-month imaging follow-up served as the reference standards to establish which of the 2 reports was correct. Among the 283 cases that met our study criteria, there were 55 neuroimaging studies with disagreements (19%) between the initial outside report and second-opinion interpretation. Patient management and/or disease stage would have been altered in 42 of 283 cases (15%) based on report differences as determined by the 2 neuro-oncologists and the surgeon participating in the study. Sufficient follow-up was available in 35 of 42 cases (83%). The second-opinion interpretation was correct 100% of the time (35/35). Second-opinion interpretations of neuroimaging studies by subspecialized oncologic neuroradiologists provide added value by reducing error and optimizing the care of cancer patients. Cancer 2016. © 2016 American Cancer Society. Cancer 2016;122:2708-2714. © 2016 American Cancer Society. © 2016 American Cancer Society.

Prevalence, Awareness and Reporting of Symptoms of Obstructive Sleep Apnoea among Hospitalized Adult Patients in Nigeria: A Multicenter Study.

PubMed

Desalu, Olufemi; Onyedum, Cajetan; Sanya, Emmanuel; Fadare, Joseph; Adeoti, Adekunle; Salawu, Fatai; Oluyombo, Rotimi; Olamoyegun, Micheal; Fawale, Micheal; Gbadegesin, Babajide; Bello, Hamzat

2016-07-01

Obstructive sleep apnoea is the most common form of sleep-disordered breathing in adults and children. It is associated with many adverse health consequences. The objectives this study were to determine the prevalence, awareness and reporting of symptoms of obstructive sleep apnoea among hospitalized adult patients in Nigeria. This was a multicenter cross-sectional study involving 1420 adult patients admitted to general medical and surgical wards of selected hospitals from March to April 2013. A questionnaire embedded with Berlin questionnaire, Epworth sleepiness scale and questions on level of awareness and reporting of symptoms of sleep apnoea was used for data collection. One-third of the patients (33.4%) reported snoring, 16.3% had excessive daytime sleepiness, 10.0% experienced daytime fatigue, and 8.0% experienced drowsy driving. Approximately 5% reported witnessed apnoea and 18.0% had high risks for obstructive sleep apnoea. The frequency of high risk for sleep apnoea increased with age and declined after 65 years and also increased with the body mass index. Snoring, excessive daytime sleepiness and high risk for obstructive sleep apnoea were more common in patients with chronic medical conditions and who were admitted to the urban hospitals. The majority were not aware that snoring (77.3%) and excessive daytime sleepiness (65.8%) constitute a medical problem, and only 4.5% reported these symptoms to their doctors. The level of awareness and under-reporting of sleep apnoea symptoms are poor. The high prevalence of obstructive sleep apnoea symptoms from this study should form the basis for screening hospitalized patients with chronic medical condition across the country.

Results of a customer-based, post-market surveillance survey of the HeRO access device.

PubMed

Fusselman, Maureen

2010-08-01

In order to supplement post-market surveillance data on the HeRO vascular access device, a non-scientific customer survey was conducted to obtain quantitative data from dialysis providers caring for patients implanted with the device. Dialysis nurses involved in the care of HeRO patients were contacted in order to obtain post-implant device performance information for 10% of patients implanted with the device at the time of the survey. Thirty-eight dialysis units with a total of 65 HeRO patients participated in the survey. The total duration of HeRO device use was 348.4 months with an average use of 5.4 months. Thirty-eight of the 65 HeRO patients (58.5%) were reported to not have experienced any performance issues. There were 28 device performance incidents reported for the remaining 27 patients included in the survey. Occlusion was the single most commonly reported device-related performance issue with 18 patients (27.7%) experiencing 25 occlusive episodes. The majority of the patients who had an occlusion (66.7%) only experienced one occlusive event. Infections occurred in 4 patients (6.2%) with an overall infection rate of 0.38 per 1,000 patient days. Post-market clinical experience during the first 18 months of commercialization of the HeRO device were in line with expectations based on the results from initial clinical studies with the device. Device occlusion remains the most commonly reported performance issue with the reported rate in this survey less than that which was reported in earlier published studies with the device.

Clinical characterization and treatment outcome of patients with burning mouth syndrome.

PubMed

Hakeem, Abdulaziz; Fitzpatrick, Sarah G; Bhattacharyya, Indraneel; Islam, Mohammed N; Cohen, Donald M

2018-01-01

Burning mouth syndrome (BMS) is a complex condition that affects the oral cavity, and data regarding effective treatment are limited. The purpose of this study was to explore the demographic and clinical information along with treatment outcomes for patients with BMS treated in a large referral center. Clinical records of the Oral Medicine Clinic at the University of Florida College of Dentistry were retrospectively searched for patients diagnosed between 2009 and 2014. Clinical data and treatment effectiveness were recorded. The records of 64 patients were included in this study. Women represented the majority of patients (81.2%), and the average age of all patients was 65 years. The most common systemic diseases were hypertension (59.4%), psycho-logical disorders (51.6%), and gastroesophageal reflux disease (50.0%). The majority of patients were taking 5 or more medications (70.3%). Treatment frequency and efficacy were as follows: a-lipoic acid, 47.5% frequency (57 prescribed treatments of 120 total treatments) and lasting improvement reported with 45.6% of prescribed treatments; clonazepam, 17.5% frequency (21/120) and improvement reported with 33.0% of prescribed treatments; oral disintegrating clonazepam, 15.8% frequency (19/120) and improvement reported with 52.6% of prescribed treatments; and topical vitamin E, 5.0% frequency (6/120) and improvement reported with 33.0% of prescribed treatments. Chi-square analysis indicated that a significantly better response to treatment was reported by women (P = 0.010) and patients who reported involvement limited to the tongue rather than multifocal oral involvement (P = 0.040); however, the significant relationships did not persist when the variables were evaluated together using logistic regression analysis. No other clinical or demographic features showed significant differences in response to treatment. Although treatment effectiveness in this study was variable and limited for some regimens due to infrequent usage, many of the patients reported alleviation of symptoms.

Physicians slow to e-mail routinely with patients.

PubMed

Boukus, Ellyn R; Grossman, Joy M; O'Malley, Ann S

2010-10-01

Some experts view e-mail between physicians and patients as a potential tool to improve physician-patient communication and, ultimately, patient care. Despite indications that many patients want to e-mail their physicians, physician adoption and use of e-mail with patients remains uncommon--only 6.7 percent of office-based physicians routinely e-mailed patients in 2008, according to a new national study from the Center for Studying Health System Change (HSC). Overall, about one-third of office-based physicians reported that information technology (IT) was available in their practice for e-mailing patients about clinical issues. Of those, fewer than one in five reported using e-mail with patients routinely; the remaining physicians were roughly evenly split between occasional users and non-users. Physicians in practices with access to electronic medical records and those working in health maintenance organizations (HMOs) or medical school settings were more likely to adopt and use e-mail to communicate with patients compared with other physicians. However, even among the highest users--physicians in group/staff-model HMOs--only 50.6 percent reported routinely e-mailing patients.

Quality of life of patients who underwent aesthetic rhinoplasty: 100 cases assessed with the Glascow Benefit Inventory.

PubMed

Kotzampasakis, Dimitrios; Piniara, Anastasia; Themelis, Sotirios; Kotzampasakis, Stylianos; Gabriel, Eustratios; Maroudias, Nikos; Nikolopoulos, Thomas

2017-09-01

The aim of the present study is to assess the long-term effect of classic rhinoplasty on patients' quality of life. Outcomes research. The study included 100 operated patients; there were 34 males and 66 females. The ages ranged between 23 and 57 years old, with a mean of 36.4 years. A minimum of 3 years between the operation and the study was selected to assess the long-term effect of the operation on the patients' quality of life and exclude any short-term impressions. The time elapsed between surgery and the time of the study ranged from 3 to 13 years, with a mean of 6.8 years. Patients were assessed using the Glasgow Benefit Inventory, which has been proven valid and reliable in ear, nose, and throat interventions. From the 100 patients included in the study, 92 reported improvement in their quality of life due to the operation and only eight worsening. In the social support subscale, 97 patients reported better quality of life, and only three patients reported worse quality of life. The patients' overall life markedly improved, reaching a mean of 80% in the Glasgow Benefit Inventory. The present long-term study using a validated and reliable instrument concludes that rhinoplasty improves the quality of life of patients in all sectors. 2c Laryngoscope, 127:2017-2025, 2017. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

Barriers to computed tomography radiation risk communication in the emergency department: a qualitative analysis of patient and physician perspectives.

PubMed

Robey, Thomas E; Edwards, Kelly; Murphy, Mary K

2014-02-01

This qualitative study aimed to characterize the barriers to informed discussions between patients and emergency physicians (EPs) about radiation risk from computed tomography (CT) and to identify future interventions to improve patient understanding of CT radiation risk. This study used a focus group approach to collect concepts about radiation risk exposure from a national sample of EPs and a local sample of emergency department (ED) patients. A directed content analysis used an a priori medical ethics framework to explore themes from the focus groups while a subsequent normative ethics analysis compared these results with existing perceptions about discussing CT radiation risk. Focus groups (three each for a total of 19 EPs and 27 patients) identified concepts consistent with core medical ethics principles: patients emphasized autonomy and nonmaleficence more than physicians, while physicians emphasized beneficence. Subjects' knowledge of radiation dose and risk were equivalent to previously published reports. When asked about whether they should talk about radiation with patients, 74% of EPs reported that radiation exposure should be discussed, but the study EPs self-reported doing so with only an average of 24% of patients. Patients reported wanting to hear about radiation from their physicians the next time they need CT scans and thought that a written handout would work better than any other method. When presented with options for how to discuss risk with patients, EPs reported needing easy access to risk information and preferred discussion over other communications approaches, but had mixed support of distributing patient handouts. The normative view that radiation from diagnostic CT should be discussed in the ED is shared by patients and physicians, but is challenged by the lack of a structured method to communicate CT radiation risk to ED patients. Our analysis identifies promising interest among physicians and patients to use information guides and electronic order prompts as potential informational tools to overcome this barrier. © 2014 by the Society for Academic Emergency Medicine.

Droxidopa and Reduced Falls in a Trial of Parkinson Disease Patients With Neurogenic Orthostatic Hypotension.

PubMed

Hauser, Robert A; Heritier, Stephane; Rowse, Gerald J; Hewitt, L Arthur; Isaacson, Stuart H

2016-01-01

Droxidopa is a prodrug of norepinephrine indicated for the treatment of orthostatic dizziness, lightheadedness, or the "feeling that you are about to black out" in adult patients with symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure including Parkinson disease (PD). The objective of this study was to compare fall rates in PD patients with symptomatic neurogenic orthostatic hypotension randomized to droxidopa or placebo. Study NOH306 was a 10-week, phase 3, randomized, placebo-controlled, double-blind trial of droxidopa in PD patients with symptomatic neurogenic orthostatic hypotension that included assessments of falls as a key secondary end point. In this report, the principal analysis consisted of a comparison of the rate of patient-reported falls from randomization to end of study in droxidopa versus placebo groups. A total of 225 patients were randomized; 222 patients were included in the safety analyses, and 197 patients provided efficacy data and were included in the falls analyses. The 92 droxidopa patients reported 308 falls, and the 105 placebo patients reported 908 falls. In the droxidopa group, the fall rate was 0.4 falls per patient-week; in the placebo group, the rate was 1.05 falls per patient-week (prespecified Wilcoxon rank sum P = 0.704; post hoc Poisson-inverse Gaussian test P = 0.014), yielding a relative risk reduction of 77% using the Poisson-inverse Gaussian model. Fall-related injuries occurred in 16.7% of droxidopa-treated patients and 26.9% of placebo-treated patients. Treatment with droxidopa appears to reduce falls in PD patients with symptomatic neurogenic orthostatic hypotension, but this finding must be confirmed.

Droxidopa and Reduced Falls in a Trial of Parkinson Disease Patients With Neurogenic Orthostatic Hypotension

PubMed Central

Hauser, Robert A.; Heritier, Stephane; Rowse, Gerald J.; Hewitt, L. Arthur; Isaacson, Stuart H.

2016-01-01

Objectives Droxidopa is a prodrug of norepinephrine indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure including Parkinson disease (PD). The objective of this study was to compare fall rates in PD patients with symptomatic neurogenic orthostatic hypotension randomized to droxidopa or placebo. Methods Study NOH306 was a 10-week, phase 3, randomized, placebo-controlled, double-blind trial of droxidopa in PD patients with symptomatic neurogenic orthostatic hypotension that included assessments of falls as a key secondary end point. In this report, the principal analysis consisted of a comparison of the rate of patient-reported falls from randomization to end of study in droxidopa versus placebo groups. Results A total of 225 patients were randomized; 222 patients were included in the safety analyses, and 197 patients provided efficacy data and were included in the falls analyses. The 92 droxidopa patients reported 308 falls, and the 105 placebo patients reported 908 falls. In the droxidopa group, the fall rate was 0.4 falls per patient-week; in the placebo group, the rate was 1.05 falls per patient-week (prespecified Wilcoxon rank sum P = 0.704; post hoc Poisson-inverse Gaussian test P = 0.014), yielding a relative risk reduction of 77% using the Poisson-inverse Gaussian model. Fall-related injuries occurred in 16.7% of droxidopa-treated patients and 26.9% of placebo-treated patients. Conclusions Treatment with droxidopa appears to reduce falls in PD patients with symptomatic neurogenic orthostatic hypotension, but this finding must be confirmed. PMID:27332626

A cloud-based home health care information sharing system to connect patients with home healthcare staff -A case report of a study in a mountainous region.

PubMed

Nomoto, Shinichi; Utsumi, Momoe; Sasayama, Satoshi; Dekigai, Hiroshi

2017-01-01

We have developed a cloud system, the e-Renraku Notebook (e-RN) for sharing of home care information based on the concept of "patient-centricity". In order to assess the likelihood that our system will enhance the communication and sharing of information between home healthcare staff members and home-care patients, we selected patients who were residing in mountainous regions for inclusion in our study. We herein report the findings.Eighteen staff members from 7 medical facilities and 9 patients participated in the present study.The e-RN was developed for two reasons: to allow patients to independently report their health status and to have staff members view and respond to the information received. The patients and staff members were given iPads with the pre-installed applications and the information being exchanged was reviewed over a 54-day period.Information was mainly input by the patients (61.6%), followed by the nurses who performed home visits (19.9%). The amount of information input by patients requiring high-level nursing care and their corresponding staff member was significantly greater than that input by patients who required low-level of nursing care.This patient-centric system in which patients can independently report and share information with a member of the healthcare staff provides a sense of security. It also allows staff members to understand the patient's health status before making a home visit, thereby giving them a sense of security and confidence. It was also noteworthy that elderly patients requiring high-level nursing care and their staff counterpart input information in the system significantly more frequently than patients who required low-level care.

Patients' online access to their electronic health records and linked online services: a systematic interpretative review.

PubMed

de Lusignan, Simon; Mold, Freda; Sheikh, Aziz; Majeed, Azeem; Wyatt, Jeremy C; Quinn, Tom; Cavill, Mary; Gronlund, Toto Anne; Franco, Christina; Chauhan, Umesh; Blakey, Hannah; Kataria, Neha; Barker, Fiona; Ellis, Beverley; Koczan, Phil; Arvanitis, Theodoros N; McCarthy, Mary; Jones, Simon; Rafi, Imran

2014-09-08

To investigate the effect of providing patients online access to their electronic health record (EHR) and linked transactional services on the provision, quality and safety of healthcare. The objectives are also to identify and understand: barriers and facilitators for providing online access to their records and services for primary care workers; and their association with organisational/IT system issues. Primary care. A total of 143 studies were included. 17 were experimental in design and subject to risk of bias assessment, which is reported in a separate paper. Detailed inclusion and exclusion criteria have also been published elsewhere in the protocol. Our primary outcome measure was change in quality or safety as a result of implementation or utilisation of online records/transactional services. No studies reported changes in health outcomes; though eight detected medication errors and seven reported improved uptake of preventative care. Professional concerns over privacy were reported in 14 studies. 18 studies reported concern over potential increased workload; with some showing an increase workload in email or online messaging; telephone contact remaining unchanged, and face-to face contact staying the same or falling. Owing to heterogeneity in reporting overall workload change was hard to predict. 10 studies reported how online access offered convenience, primarily for more advantaged patients, who were largely highly satisfied with the process when clinician responses were prompt. Patient online access and services offer increased convenience and satisfaction. However, professionals were concerned about impact on workload and risk to privacy. Studies correcting medication errors may improve patient safety. There may need to be a redesign of the business process to engage health professionals in online access and of the EHR to make it friendlier and provide equity of access to a wider group of patients. A1 SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42012003091. 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.

Outcomes of Patients With Relapsed Hepatoblastoma Enrolled on Children's Oncology Group (COG) Phase I and II Studies.

PubMed

Trobaugh-Lotrario, Angela D; Meyers, Rebecka L; Feusner, James H

2016-04-01

Data are limited regarding outcomes of patients treated for relapsed hepatoblastoma. We reviewed enrollment patterns and outcomes of patients with hepatoblastoma on Children's Oncology Group (COG) phase I/II studies. The medical literature was searched for reports of COG phase I/II studies using PUBMED as well as an inventory from the COG publications office searching manuscripts published from 2000 to 2014. Seventy-one patients with relapsed hepatoblastoma were enrolled on 23 separate COG phase I/II studies. Four studies collected α-fetoprotein (AFP) data, but none utilized AFP decline in assessing response. Most studies enrolled few patients with relapsed hepatoblastoma: 7 studies enrolled 1 patient, and another 7 studies enrolled 2 patients each. Only 9 studies enrolled 3 or more patients with relapsed hepatoblastoma. Four responses were reported. Dedicated strata and/or focus on 1 or 2 studies with compelling biological or clinical rationale for hepatoblastoma may improve accrual (and statistical significance of response data) of patients with relapsed hepatoblastoma. Prospective study of AFP decline versus RECIST response could help determine the optimal method of assessing response to identify potentially beneficial treatments in hepatoblastoma.

Optimal functional outcome measures for assessing treatment for Dupuytren’s disease: a systematic review and recommendations for future practice

PubMed Central

2013-01-01

Background Dupuytren's disease of the hand is a common condition affecting the palmar fascia, resulting in progressive flexion deformities of the digits and hence limitation of hand function. The optimal treatment remains unclear as outcomes studies have used a variety of measures for assessment. Methods A literature search was performed for all publications describing surgical treatment, percutaneous needle aponeurotomy or collagenase injection for primary or recurrent Dupuytren’s disease where outcomes had been monitored using functional measures. Results Ninety-one studies met the inclusion criteria. Twenty-two studies reported outcomes using patient reported outcome measures (PROMs) ranging from validated questionnaires to self-reported measures for return to work and self-rated disability. The Disability of Arm, Shoulder and Hand (DASH) score was the most utilised patient-reported function measure (n=11). Patient satisfaction was reported by eighteen studies but no single method was used consistently. Range of movement was the most frequent physical measure and was reported in all 91 studies. However, the methods of measurement and reporting varied, with seventeen different techniques being used. Other physical measures included grip and pinch strength and sensibility, again with variations in measurement protocols. The mean follow-up time ranged from 2 weeks to 17 years. Conclusions There is little consistency in the reporting of outcomes for interventions in patients with Dupuytren’s disease, making it impossible to compare the efficacy of different treatment modalities. Although there are limitations to the existing generic patient reported outcomes measures, a combination of these together with a disease-specific questionnaire, and physical measures of active and passive individual joint Range of movement (ROM), grip and sensibility using standardised protocols should be used for future outcomes studies. As Dupuytren’s disease tends to recur following treatment as well as extend to involve other areas of the hand, follow-up times should be standardised and designed to capture both short and long term outcomes. PMID:23575442

Health-Related Quality of Life, Treatment Satisfaction, Adherence and Persistence in β-Thalassemia and Myelodysplastic Syndrome Patients with Iron Overload Receiving Deferasirox: Results from the EPIC Clinical Trial

PubMed Central

Porter, John; Bowden, Donald K.; Economou, Marina; Troncy, Jacques; Ganser, Arnold; Habr, Dany; Martin, Nicolas; Gater, Adam; Rofail, Diana; Abetz-Webb, Linda; Lau, Helen; Cappellini, Maria Domenica

2012-01-01

Treatment of iron overload using deferoxamine (DFO) is associated with significant deficits in patients' health-related quality of life (HRQOL) and low treatment satisfaction. The current article presents patient-reported HRQOL, satisfaction, adherence, and persistence data from β-thalassemia (n = 274) and myelodysplastic syndrome (MDS) patients (n = 168) patients participating in the Evaluation of Patients' Iron Chelation with Exjade (EPIC) study (NCT00171821); a large-scale 1-year, phase IIIb study investigating the efficacy and safety of the once-daily oral iron chelator, deferasirox. HRQOL and satisfaction, adherence, and persistence to iron chelation therapy (ICT) data were collected at baseline and end of study using the Medical Outcomes Short-Form 36-item Health Survey (SF-36v2) and the Satisfaction with ICT Questionnaire (SICT). Compared to age-matched norms, β-thalassemia and MDS patients reported lower SF-36 domain scores at baseline. Low levels of treatment satisfaction, adherence, and persistence were also observed. HRQOL improved following treatment with deferasirox, particularly among β-thalassemia patients. Furthermore, patients reported high levels of satisfaction with deferasirox at end of study and greater ICT adherence, and persistence. Findings suggest deferasirox improves HRQOL, treatment satisfaction, adherence, and persistence with ICT in β-thalassemia and MDS patients. Improving such outcomes is an important long-term goal for patients with iron overload. PMID:22924125

Osteoporosis and bisphosphonate-related osteonecrosis in a dental school implant patient population.

PubMed

Al-Sabbagh, Mohanad; Robinson, Fonda G; Romanos, Georgios; Thomas, Mark V

2015-06-01

Studies have demonstrated an inconsistent association between implant failure and bone mineral density. The prevalence of osteoporosis in US adults has been reported to range from 5% to 10% in women and from 2% to 4% in men. The prevalence of bisphosphonate (BP)-related osteonecrosis of the jaw (BRONJ) has been reported to range from 0% to 4.3% of patients taking oral BPs. The purpose of this study was to calculate the risk of dental implant loss and the incidence of BRONJ in patients with osteoporosis at the University of Kentucky College of Dentistry (UKCD). This study analyzed data collected from patients who had implants placed between 2000 and 2004 at UKCD. Data were gathered from patient interviews regarding implant survival and patient-satisfaction parameters, and interviews were conducted either chairside at a scheduled maintenance appointment or by telephone interview. Among 203 patients who received 515 implants, the prevalence of osteoporosis was 23.3% for women and 1.2% for men. None of the 20 patients who reported a history of oral BP use exhibited BRONJ, and there were no implant failures in patients with a history of osteoporosis. In this study, osteoporosis conferred no risk of implant failure, and oral BP therapy was not associated with BRONJ.

Revision Hip Arthroscopy: A Systematic Review of Diagnoses, Operative Findings, and Outcomes.

PubMed

Cvetanovich, Gregory L; Harris, Joshua D; Erickson, Brandon J; Bach, Bernard R; Bush-Joseph, Charles A; Nho, Shane J

2015-07-01

To determine indications for, operative findings of, and outcomes of revision hip arthroscopy. A systematic review was registered with PROSPERO and performed based on PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Therapeutic clinical outcome studies reporting the indications for, operative findings of, and outcomes of revision hip arthroscopy were eligible for inclusion. All study-, patient-, and hip-specific data were extracted and analyzed. The Modified Coleman Methodology Score was used to assess study quality. Five studies were included (348 revision hip arthroscopies; 333 patients; mean age, 31.4 ± 4.2 years; 60% female patients). All 5 studies were either Level III or IV evidence. The surgeon performing revision hip arthroscopy was the same as the primary hip surgeon in only 25% of cases. The mean time between primary and revision hip arthroscopy was 27.8 ± 7.0 months (range, 2 to 193 months). Residual femoroacetabular impingement was the most common indication for and operative finding of revision hip arthroscopy (81% of cases). The most commonly reported revision procedures were femoral osteochondroplasty (24%) and acetabuloplasty (18%). The modified Harris Hip Score was used in all 5 analyzed studies, with significant (P < .05) improvements observed in all 5 studies (weighted mean, 56.8 ± 3.6 preoperatively v 72.0 ± 8.3 at final follow-up [22.4 ± 9.8 months]; P = .01). Other patient-reported outcomes (Non-Arthritic Hip Score, Hip Outcome Score, 33-item International Hip Outcome Tool, Short Form 12) showed significant improvements but were not used in all 5 analyzed studies. After revision hip arthroscopy, subsequent reported operations were hip arthroplasty in 11 patients and re-revision hip arthroscopy in 8 patients (5% total reoperation rate). Revision hip arthroscopy is most commonly performed for residual femoroacetabular impingement, with statistically significant and clinically relevant improvements shown in multiple patient-reported clinical outcome scores at short-term follow-up. The reoperation rate after revision hip arthroscopy is 5% within 2 years, including further arthroscopy or conversion to hip arthroplasty. Level IV, systematic review of Level III and IV studies. Copyright © 2015 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Characteristics, Quality and Contribution to Signal Detection of Spontaneous Reports of Adverse Drug Reactions Via the WEB-RADR Mobile Application: A Descriptive Cross-Sectional Study.

PubMed

Oosterhuis, Ingrid; Taavola, Henric; Tregunno, Philip M; Mas, Petar; Gama, Sara; Newbould, Victoria; Caster, Ola; Härmark, Linda

2018-05-14

Spontaneous reporting of suspected adverse drug reactions is key for efficient post-marketing safety surveillance. To increase usability and accessibility of reporting tools, the Web-Recognising Adverse Drug Reactions (WEB-RADR) consortium developed a smartphone application (app) based on a simplified reporting form. The objective of this study was to evaluate the characteristics, quality and contribution to signals of reports submitted via the WEB-RADR app. The app was launched in the UK, the Netherlands and Croatia between July 2015 and May 2016. Spontaneous reports submitted until September 2016 with a single reporter were included. For each country, app reports and reports received through conventional means in the same time period were compared to identify characteristic features. A random subset of reports was assessed for clinical quality and completeness. The contribution to signal detection was assessed by a descriptive analysis. Higher proportions of app reports were submitted by patients in the UK (28 vs. 18%) and Croatia (32 vs. 7%); both p < 0.01. In the Netherlands, the difference was small (60 vs. 57%; p = 0.5). The proportion of female patients and the median patient ages in app reports submitted by patients were similar to the reference. The proportion of reports of at least moderate quality was high in both samples (app: 78-85%, reference: 78-98%), for all countries. App reports contributed to detecting eight potential safety signals at the national level, four of which were eventually signalled. The WEB-RADR app offers a new route of spontaneous reporting that shows promise in attracting reports from patients and that could become an important tool in the future. Patient demographics are similar to conventional routes, report quality is sufficient despite a simplified reporting form, and app reports show potential in contributing to signal detection.

Pharmacy study of natural health product adverse reactions (SONAR): a cross-sectional study using active surveillance in community pharmacies to detect adverse events associated with natural health products and assess causality.

PubMed

Necyk, Candace; Tsuyuki, Ross T; Boon, Heather; Foster, Brian C; Legatt, Don; Cembrowski, George; Murty, Mano; Barnes, Joanne; Charrois, Theresa L; Arnason, John T; Ware, Mark A; Rosychuk, Rhonda J; Vohra, Sunita

2014-03-28

To investigate the rates and causality of adverse event(s) (AE) associated with natural health product (NHP) use, prescription drug use and concurrent NHP-drug use through active surveillance in community pharmacies. Cross-sectional study of screened patients. 10 community pharmacies across Alberta and British Columbia, Canada from 14 January to 30 July 2011. The participating pharmacy staff screened consecutive patients, or agents of patients, who were dropping or picking up prescription medications. Patients were screened to determine the proportions of them using prescription drugs and/or NHPs, as well as their respective AE rates. All AEs reported by the screened patients who took a NHP, consented to, and were available for, a detailed telephone interview (14%) were adjudicated fully to assess for causality. Over a total of 105 pharmacy weeks and 1118 patients screened, 410 patients reported taking prescription drugs only (36.7%; 95% CI 33.9% to 39.5%), 37 reported taking NHPs only (3.3%; 95% CI 2.4% to 4.5%) and 657 reported taking prescription drugs and NHPs concurrently (58.8%; 95% CI 55.9% to 61.6%). In total, 54 patients reported an AE, representing 1.2% (95% CI 0.51% to 2.9%), 2.7% (95% CI 0.4% to 16.9%) and 7.3% (95% CI 5.6% to 9.6%) of each population, respectively. Compared with patients who reported using prescription drugs, the patients who reported using prescription drugs and NHPs concurrently were 6.4 times more likely to experience an AE (OR; 95% CI 2.52 to 16.17; p<0.001). Combined with data from Ontario, Canada, a national proportion was calculated, which found that 45.4% (95% CI 43.8% to 47.0%) of Canadians who visit community pharmacies take NHPs and prescription drugs concurrently, and of those, 7.4% (95% CI 6.3% to 8.8%) report an AE. A substantial proportion of community pharmacy patients use prescription drugs and NHPs concurrently; these patients are at a greater risk of experiencing an AE. Active surveillance provides a means of detecting such AEs and collecting high-quality data on which causality assessment can be based.

Medical marijuana use in head and neck squamous cell carcinoma patients treated with radiotherapy.

PubMed

Elliott, David A; Nabavizadeh, Nima; Romer, Jeanna L; Chen, Yiyi; Holland, John M

2016-08-01

The purpose of the study was to better understand why patients with history of head and neck cancer (HNC) treated with radiotherapy are using medical marijuana (MM). Established HNC quality of life questionnaires and our own MM quality of life questionnaire were sent to 15 HNC patients treated at our institution who reported using MM. Patients are clinically disease free and currently using MM to manage long-term side effects after curative HNC treatment. There was a 100 % response rate. Median time from treatment was 45 months (21-136 months). Most patients smoked marijuana (12 patients), while others reported ingestion (4 patients), vaporizing (3 patients), and use of homemade concentrated oil (1 patient). Six patients reported prior recreational marijuana use before diagnosis. MM provided benefit in altered sense, weight maintenance, depression, pain, appetite, dysphagia, xerostomia, muscle spasm, and sticky saliva. HNC patients report MM use to help with long-term side effects of radiotherapy.

Patient-reported allergies cause inferior outcomes after total knee arthroplasty.

PubMed

Hinarejos, Pedro; Ferrer, Tulia; Leal, Joan; Torres-Claramunt, Raul; Sánchez-Soler, Juan; Monllau, Joan Carles

2016-10-01

The main objective of this study was to analyse the outcomes after total knee arthroplasty (TKA) of a group of patients with at least one self-reported allergy and a group of patients without reported allergies. We hypothesized there is a significant negative influence on clinical outcome scores after TKA in patients with self-reported allergies. Four-hundred and seventy-five patients who had undergone TKA were analysed preoperatively and 1 year after surgery. The WOMAC, KSS and SF-36 scores were obtained. The patients' Yesavage depression questionnaire score was also recorded. The scores of the 330 (69.5 %) patients without self-reported allergies were compared to the scores of the 145 (30.5 %) patients with at least one self-reported allergy in the medical record. Preoperative scores were similar in both groups. The WOMAC post-operative scores (23.6 vs 20.4; p = 0.037) and the KSS-Knee score (91.1 vs 87.6; p = 0.027) were worse in the group of patients with self-reported allergies than in the group without allergies. The scores from the Yesavage depression questionnaire and in the SF-36 were similar in both groups. Patients with at least one self-reported allergy have worse post-operative outcomes in terms of the WOMAC and KSS-Knee scores after TKA than patients without allergies. These poor outcomes do not seem to be related to depression. Therefore, more research is needed to explain them. Reported allergies could be considered a prognostic factor and used when counselling TKA patients. I.

Comorbid depression and associated factors in PNES versus epilepsy: Systematic review and meta-analysis.

PubMed

Walsh, Sean; Levita, Liat; Reuber, Markus

2018-05-24

This systematic review aims to contrast levels, manifestations and associations of depression in patients with psychogenic non-epileptic seizures (PNES) and those with epilepsy. ScienceDirect and Web of Science were searched for primary research reports describing quantitative studies involving separate epilepsy and PNES samples (age 16+) and using a validated measure of depression. While 34 studies were identified, most were of low quality and had small sample sizes. Studies consistently found higher levels of self-reported depression in the PNES than epilepsy groups, with a meta-analysis demonstrating a significant difference between the groups. Although patients with PNES were also more likely to have a clinical diagnosis of depression than those with epilepsy, the difference between the groups was less pronounced in studies based on such diagnoses rather than self-report. Patients with PNES were more likely to report physical symptoms of depression than those with epilepsy. Interpersonal factors explained more variation in depression levels in patients with PNES than those with epilepsy, for whom illness related factors were more influential, but in both patient groups, depression had a significant impact on health related quality of life. This systematic review demonstrates a higher prevalence of depression in patients with PNES compared to patients with epilepsy and suggests differences in the expression and possible causes of depression between these groups. Copyright © 2018 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Phentermine, sibutramine and affective disorders.

PubMed

An, Hoyoung; Sohn, Hyunjoo; Chung, Seockhoon

2013-04-01

A safe and effective way to control weight in patients with affective disorders is needed, and phentermine is a possible candidate. We performed a PubMed search of articles pertaining to phentermine, sibutramine, and affective disorders. We compared the studies of phentermine with those of sibutramine. The search yielded a small number of reports. Reports concerning phentermine and affective disorders reported that i) its potency in the central nervous system may be comparatively low, and ii) it may induce depression in some patients. We were unable to find more studies on the subject; thus, it is unclear presently whether phentermine use is safe in affective disorder patients. Reports regarding the association of sibutramine and affective disorders were slightly more abundant. A recent study that suggested that sibutramine may have deleterious effects in patients with a psychiatric history may provide a clue for future phentermine research. Three explanations are possible concerning the association between phentermine and affective disorders: i) phentermine, like sibutramine, may have a depression-inducing effect that affects a specific subgroup of patients, ii) phentermine may have a dose-dependent depression-inducing effect, or iii) phentermine may simply not be associated with depression. Large-scale studies with affective disorder patients focusing on these questions are needed to clarify this matter before investigation of its efficacy may be carried out and it can be used in patients with affective disorders.

The relationship between voice climate and patients’ experience of timely care in primary care clinics

PubMed Central

Nembhard, Ingrid M.; Yuan, Christina T.; Shabanova, Veronika; Cleary, Paul D.

2017-01-01

Background Aspects of the patient care experience, despite being central to quality care, are often problematic. In particular, patients frequently report problems with timeliness of care. As yet, research offers little insight on setting characteristics that contribute to patients’ experience of timely care. Purpose The aims of this study were to assess the relationship between organizational climate and patients’ reports of timely care in primary care clinics and to broadly examine the link between staff’s work environment and patient care experiences. We test hypotheses about the relationship between voice climate—staff feeling safe to speak up about issues—and reported timeliness of care, consistency in reported voice climate across professions, and how climate differences for various professions relate to timely care. Methodology We conducted a cross-sectional study of employees (n = 1,121) and patients (n = 8,164) affiliated with 37 clinics participating in a statewide reporting initiative. Employees were surveyed about clinics’ voice climate, and patients were surveyed about the timeliness of care. Hypotheses were tested using analysis of variance and generalized estimating equations. Findings Clinical and administrative staff (e.g., nurses and office assistants) reported clinics’ climates to be significantly less supportive of voice than did clinical leaders (e.g., physicians). The greater the difference in reported support for voice between professional groups, the less patients reported experiencing timely care in three respects: obtaining an appointment, seeing the doctor within 15 minutes of appointment time, and receiving test results. In clinics where staff reported climates supportive of voice, patients indicated receiving more timely care. Clinical leaders’ reports of voice climate had no relationship to reported timeliness of care. Practical Implications Our findings suggest the importance of clinics developing a strong climate for voice, particularly for clinical and administrative staff, to support better service quality for patients. PMID:24589927

Computer use in primary care and patient-physician communication.

PubMed

Sobral, Dilermando; Rosenbaum, Marcy; Figueiredo-Braga, Margarida

2015-07-08

This study evaluated how physicians and patients perceive the impact of computer use on clinical communication, and how a patient-centered orientation can influence this impact. The study followed a descriptive cross-sectional design and included 106 family physicians and 392 patients. An original questionnaire assessed computer use, participants' perspective of its impact, and patient centered strategies. Physicians reported spending 42% of consultation time in contact with the computer. A negative impact of computer in patient-physician communication regarding the consultation length, confidentiality, maintaining eye contact, active listening to the patient, and ability to understand the patient was reported by physicians, while patients reported a positive effect for all the items. Physicians considered that the usual computer placement in their consultation room was significantly unfavorable to patient-physician communication. Physicians perceive the impact of computer use on patient-physician communication as negative, while patients have a positive perception of computer use on patient-physician communication. Consultation support can represent a challenge to physicians who recognize its negative impact in patient centered orientation. Medical education programs aiming to enhance specific communication skills and to better integrate computer use in primary care settings are needed. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Self-reported quality of ADL task performance among patients with COPD exacerbations.

PubMed

Bendixen, Hans Jørgen; Wæhrens, Eva Ejlersen; Wilcke, Jon Torgny; Sørensen, Lisbeth Villemoes

2014-07-01

Patients suffering from chronic obstructive pulmonary disease (COPD) experience problems in the performance of activities of daily living (ADL) tasks. The objective was to examine the self-reported quality of ADL task performance among COPD patients, and to investigate whether age, gender, and routine COPD characteristics correlate with the self-reported ADL ability. Eighty patients admitted to hospital with COPD exacerbations participated. In a cross-sectional study, the patients' self-reported ADL ability was assessed using the ADL-Interview (ADL-I) instrument. Data concerning age, gender, and routine COPD characteristics were drawn from the patients' medical records. The patients reported being inefficient to markedly inefficient when performing ADL tasks within the personal hygiene, toileting, dressing, household, mobility, and transportation domains. While more than 90% of the participants reported increased effort and/or fatigue when performing the ADL tasks, up to 88% of the participants relied on help from others in the performance of general household chores like cooking and shopping. Self-reported ADL ability did not correlate with age, gender, or routine COPD characteristics. Decreased quality of ADL task performance seemed to be extremely common among COPD patients. Therefore, addressing the problems in individually tailored pulmonary rehabilitation programmes may be advantageous.

Root Canal Therapy Reduces Multiple Dimensions of Pain: A National Dental PBRN Study

PubMed Central

Law, Alan S.; Nixdorf, Donald R.; Rabinowitz, Ira; Reams, Gregory J.; Smith, James A.; Torres, Anibal V.; Harris, D. Robert

2014-01-01

Background Initial orthograde root canal therapy (RCT) is used to treat dentoalveolar pathosis. The affect RCT has on pain intensity has been frequently reported, but the affect on other dimensions of pain has not. Also, the lack of large prospective studies involving diverse groups of patients and practitioners that are not involved in data collection suggest that there are multiple opportunities for bias to be introduced when this data is systematically aggregated. Method This prospective observational study assessed pain intensity, duration, and its interference with daily activities among RCT patients. Sixty-two practitioners (46 general dentists, 16 endodontists) in the National Dental Practice-Based Research Network enrolled patients requiring RCT. Patient reported data were collected before, immediately following, and one week after treatment using the Graded Chronic Pain Scale. Results Enrollment of 708 patients was completed over 6 months with 655 patients (93%) providing one-week follow-up data. Prior to treatment, patients reported a mean (±standard deviation) worst pain intensity of 5.3±3.8 (0-10 scale), 50% had “severe” pain (≥7), and mean days in pain and days pain interfered with activities were 3.6±2.7 and 0.5±1.2, respectively. Following treatment, patients reported a mean worst pain intensity of 3.0±3.2, 19% had “severe” pain, and mean days in pain and days with pain interference were 2.1±2.4 and 0.4±1.1, respectively. All changes were statistically significant (p<0.0001). Conclusions RCT is an effective treatment for patients experiencing pain, significantly reducing pain intensity, duration, and related interference. Further research is needed to reduce the proportion of patients reporting “severe” post-operative pain. PMID:25190605

Impact of Patient-centered eHealth Applications on Patient Outcomes: A Review on the Mediating Influence of Human Factor Issues.

PubMed

Wildenbos, G A; Peute, L W; Jaspers, M W M

2016-11-10

To examine the evidence of the impact of patient- centered eHealth applications on patient care and to analyze if and how reported human factor issues mediated the outcomes. We searched PubMed (2014-2015) for studies evaluating the impact of patient-centered eHealth applications on patient care (behavior change, self-efficacy, and patient health-related outcomes). The Systems Engineering Initiative for Patient Safety (SEIPS 2.0) model was used as a guidance framework to identify the reported human factors possibly impacting the effectiveness of an eHealth intervention. Of the 348 potentially relevant papers, 10 papers were included for data analysis. None of the 10 papers reported a negative impact of the eHealth intervention. Seven papers involved a randomized controlled trial (RCT) study. Six of these RCTs reported a positive impact of the eHealth intervention on patient care. All 10 papers reported on human factor issues possibly mediating effects of patient-centered eHealth. Human factors involved patient characteristics, perceived social support, and (type of) interaction between patient and provider. While the amount of patient-centered eHealth interventions increases, many questions remain as to whether and to what extent human factors mediate their use and impact. Future research should adopt a formal theory-driven approach towards human factors when investigating those factors' influence on the effectiveness of these interventions. Insights could then be used to better tailor the content and design of eHealth solutions according to patient user profiles, so as to enhance eHealth interventions impact on patient behavior, self-efficacy, and health-related outcomes.

Self-reported emotional dysregulation but no impairment of emotional intelligence in borderline personality disorder: an explorative study.

PubMed

Beblo, Thomas; Pastuszak, Anna; Griepenstroh, Julia; Fernando, Silvia; Driessen, Martin; Schütz, Astrid; Rentzsch, Katrin; Schlosser, Nicole

2010-05-01

Emotional dysfunction is a key feature of patients with borderline personality disorder (BPD) but emotional intelligence (EI) has rarely been investigated in this sample. This study aimed at an investigation of ability EI, general intelligence, and self-reported emotion regulation in BPD. We included 19 patients with BPD and 20 healthy control subjects in the study. EI was assessed by means of the Mayer-Salovey-Caruso emotional intelligence test and the test of emotional intelligence. For the assessment of general intelligence, we administered the multidimensional "Leistungsprüfsystem-Kurzversion." The emotion regulation questionnaire and the difficulties in Emotion Regulation Scale were used to assess emotion regulation. The patients with BPD did not exhibit impairments of ability EI and general intelligence but reported severe impairments in emotion regulation. Ability EI was related both to general intelligence (patients and controls) and to self-reported emotion regulation (patients). In conclusion, emotional dysfunction in BPD might primarily affect self-perceived behavior rather than abilities. Intense negative emotions in everyday life may trigger dysfunctional emotion regulation strategies in BPD although patients possess sufficient theoretical knowledge about optimal regulation strategies.

Health-related Quality of Life in Patients on Hemodialysis and Peritoneal Dialysis: a Meta-Analysis of Iranian Studies.

PubMed

Homaie Rad, Enayatollah; Mostafavi, Hakimeh; Delavari, Sajad; Mostafavi, Sahar

2015-09-01

Health-related quality of life (HRQOL) is an index to calculate wellbeing of patients and is an important concept in patients with end-stage renal disease.  There are many studies calculating HRQOL for patients on different treatment modalities of end-stage renal disease. Pooling reports from Iran, this systematic review aimed to measure the HRQOL in patients on hemodialysis and peritoneal dialysis using meta-analysis techniques. Four databases including PubMed and Scopus in English and the SID and IranMedex in Persian were searched. Based on the inclusion criteria, 26 English and Persian-language articles reporting HRQOL in the scales between zero and 100 (or scales convertible to this range) for hemodialysis or PD were included in the meta-analysis. The mean HRQOL scores ranged between 34.40 and 69.16 for hemodialysis reports and between 38.00 and 65.70 for PD reports. The pooled quality of life scores for hemodialysis and PD were 52.257 and 52.722, respectively (t = 0.928, P = .36). The results showed that HRQOL in patients using hemodialysis and peritoneal dialysis were not significantly different. Similar studies in other countries had found similar results.

Feasibility of an interactive ICT-platform for early assessment and management of patient-reported symptoms during radiotherapy for prostate cancer.

PubMed

Sundberg, Kay; Eklöf, Ann Langius; Blomberg, Karin; Isaksson, Ann-Kristin; Wengström, Yvonne

2015-10-01

The aim of this study was to test the feasibility and acceptability of an Information and Communication Technology platform for assessing and managing patient reported symptoms during radiotherapy for prostate cancer. In cooperation with a health management company, using a patient experience co-design, we developed the platform operated by an interactive application for reporting and managing symptoms in real time. Nine patients diagnosed with prostate cancer and receiving radiotherapy were recruited from two university hospitals in Sweden. Evidence-based symptoms and related self-care advice specific to prostate cancer were implemented in the application based on a literature review and interviews with patients and health care professionals. In the test of the platform the patients reported symptoms, via a mobile phone, daily for two weeks and were afterwards interviewed about their experiences. Overall, the patients found the symptom questionnaire and the self-care advice relevant and the application user friendly. The alert system was activated on several occasions when the symptoms were severe leading to a nurse contact and support so the patients felt safe and well cared for. The platform enabled increased patient involvement and facilitated symptom assessment and communication between the patient and the health care provider. The study's results support further development of the platform, as well as tests in full-scale studies and in other populations. Copyright © 2015 Elsevier Ltd. All rights reserved.

Interpreting change from patient reported outcome (PRO) endpoints: patient global ratings of concept versus patient global ratings of change, a case study among osteoporosis patients.

PubMed

Nixon, Annabel; Doll, Helen; Kerr, Cicely; Burge, Russel; Naegeli, April N

2016-02-19

Regulatory guidance recommends anchor-based methods for interpretation of treatment effects measured by PRO endpoints. Methodological pros and cons of patient global ratings of change vs. patient global ratings of concept have been discussed but empirical evidence in support of either approach is lacking. This study evaluated the performance of patient global ratings of change and patient global ratings of concept for interpreting patient stability and patient improvement. Patient global ratings of change and patient global ratings of concept were included in a psychometric validation study of an osteoporosis-targeted PRO instrument (the OPAQ-PF) to assess its ability to detect change and to derive responder definitions. 144 female osteoporosis patients with (n = 37) or without (n = 107) a recent (within 6 weeks) fragility fracture completed the OPAQ-PF and global items at baseline, 2 weeks (no recent fracture), and 12 weeks (recent fracture) post-baseline. Results differed between the two methods. Recent fracture patients reported more improvement while patients without recent fracture reported more stability on ratings of change than ratings of concept. However, correlations with OPAQ-PF score change were stronger for ratings of concept than ratings of change (both groups). Effect sizes for OPAQ-PF score change increased consistently with level of change in ratings of concept but inconsistently with ratings of change, with the mean AUC for prediction of a one-point change being 0.72 vs. 0.56. This study provides initial empirical support for methodological and regulatory recommendations to use patient global ratings of concept rather than ratings of change when interpreting change captured by PRO instruments in studies evaluating treatment effects. These findings warrant being confirmed in a purpose-designed larger scale analysis.

Impact of a walking intervention on cardiorespiratory fitness, self-reported physical function, and pain in patients undergoing treatment for solid tumors.

PubMed

Griffith, Kathleen; Wenzel, Jennifer; Shang, JingJing; Thompson, Carol; Stewart, Kerry; Mock, Victoria

2009-10-15

Cancer treatment is associated with decline in measured and self-reported physical function and increased pain. In the current study, the authors evaluated the impact of a walking intervention on these outcomes during chemotherapy/radiation. Patients with breast, prostate, and other cancers (N=126) were randomized to a home-based walking intervention (exercise) or usual care (control). Exercise dose during the intervention was assessed using a 5-item Physical Activity Questionnaire. Outcome measures were cardiorespiratory fitness, expressed as peak oxygen uptake (VO2) measured during treadmill testing (n=85) or estimated by 12-minute walk (n=27), and self-reported physical function, role limitations, and pain derived from Medical Outcomes Study Short Form 36. Linear regression was used to evaluate pre-to-post intervention change outcomes between groups. The mean (standard deviation) age of the patients was 60.2 (10.6) years. Diagnoses included prostate (55.6%) and breast (32.5%) cancer. Treatment included external beam radiotherapy (52.3%) and chemotherapy (34.9%). Exercise patients reported worsening Medical Outcomes Study physical function role limitations by the end of cancer treatment (P=.037). Younger age was associated with improved Medical Outcomes Study physical function (P=.048). In all patients, increased exercise dose was associated with decreased Medical Outcomes Study pain (P=.046), regardless of diagnosis. The percent change of VO2 between prostate and nonprostate cancer patients when adjusted for baseline VO2 and Physical Activity Questionnaire values was 17.45% (P=.008), with better VO2 maintenance in the prostate group. Exercise during cancer treatment improves cardiorespiratory fitness and self-reported physical function in prostate cancer patients and in younger patients, regardless of diagnosis, and may attenuate loss of those capacities in patients undergoing chemotherapy. Exercise also reduces the pain experience. Copyright (c) 2009 American Cancer Society.

Financial hardship and the intensity of medical care received near death.

PubMed

Tucker-Seeley, Reginald D; Abel, Gregory A; Uno, Hajime; Prigerson, Holly

2015-05-01

Although end-of-life (EOL) care can present a substantial financial burden for the household, the influence of this burden on the intensity of care received at the EOL remains unknown. The goal of this study was to determine the association between financial hardship and intensive care in the last week of life. The Coping with Cancer (CwC) Study is a longitudinal, multisite cohort study of terminally ill cancer patients and their informal caregivers, September 2002-February 2008. Patients (N = 281) were followed from baseline to death, a median of 4.4 months after baseline assessment. Intensive care was defined as the use of resuscitation and/or ventilation in the patient's last week of life. Financial hardship was measured at study baseline as a positive response to whether the household had to use all or most of their savings because of the family member's illness. Twenty-nine percent reported financial hardship, and 9% received intensive EOL care. Patients reporting financial hardship had a 3.22 (95% CI: 1.38, 7.53) higher likelihood of receiving intensive EOL care compared with patients not reporting financial hardship. After adjusting for sociodemographic characteristics and patient preferences, patients reporting financial hardship had a 3.05 (95% CI: 1.22, 7.62) higher likelihood of receiving intensive EOL care. The depletion of a family's financial resources is a significant predictor of intensive EOL care, over and above the influence of sociodemographic characteristics and patient preferences. Copyright © 2014 John Wiley & Sons, Ltd.

Liver Resection for Colorectal Hepatic Metastases after Systemic Chemotherapy and Selective Internal Radiation Therapy with Yttrium-90 Microspheres: A Systematic Review.

PubMed

Baltatzis, Minas; Siriwardena, Ajith K

2018-06-08

Selective internal radiation therapy (SIRT) using yttrium-90 resin microspheres has been used together with systemic chemotherapy to treat patients with unresectable liver metastases. This study undertook the first systematic pooled assessment of the case profile, treatment and outcome in patients with initially inoperable colorectal hepatic metastases undergoing resection after systemic chemotherapy and SIRT. A systematic review of the literature was performed using Medline and Embase for publications between January 1998 and August 2017. Keywords and MESH headings "SIRT", "Yttrium-99 radio embolization" and "liver metastases" were used. Reports on patients undergoing liver resection after SIRT for colorectal liver metastases were included. Case reports, reviews and papers without original data were excluded. The study protocol was registered with PROSPERO, (registration number: CRD42017072374). The study population comprised of 120 patients undergoing liver resection after chemotherapy and SIRT. The conversion rate to hepatectomy in previously unresectable patients was 13.6% (109 of 802). All studies report a single application of SIRT. The interval from SIRT to surgery ranged from 39 days to 9 months. Overall, there were 4 (3.3%) deaths after hepatectomy in patients treated by chemotherapy and SIRT. This large pooled report of patients undergoing hepatectomy for colorectal liver metastases after chemotherapy and SIRT shows that 13.6% of patients with initially inoperable disease undergo resection with low procedure-related mortality. © 2018 S. Karger AG, Basel.

Characteristics of psoriasis in Greece: an epidemiological study of a population in a sunny Mediterranean climate.

PubMed

Rigopoulos, Dimitris; Gregoriou, Stamatis; Katrinaki, Aimilia; Korfitis, Chrysovalantis; Larios, Giorgos; Stamou, Christos; Mourellou, Olympia; Petridis, Athanasios; Rallis, Efstathios; Sotiriadis, Dimitris; Katsambas, Andreas D; Antoniou, Christina

2010-01-01

Psoriasis is a chronic inflammatory skin disease with important socioeconomic consequences. Data on psoriasis prevalence in Greece is scarce and circumstantially reported. The aim of this study was the recording of psoriatic patients' demographic data, clinical characteristics of the disease, and exacerbating factors. Seven hundred and eighty four patients were enrolled in 6 centres (4 in Athens and 2 in Thessaloniki) in a multicenter epidemiologic prospective study. The mean age of patients was 43.2 (standard deviation, SD 17.44) years (median 42 years), while the men: women ratio was 1.8:1. Additionally, 35% of patients reported a positive family history of psoriasis. The mean age of patients at the first episode of psoriasis was 31.3 (SD 16.39) years (median 28 years). Psoriasis vulgaris was the most common form of psoriasis in the population participating in this study. Flares of psoriasis occurred 2.6 times per year on average. The patients considered stress as the main cause for psoriasis exacerbation. Most frequent target points of psoriasis included elbows, legs, scalp and knees. The most common symptoms reported were scaling, and itching. On average, patients visited dermatologists 2.4 times per year for issues related to psoriasis. This study provides epidemiological information regarding psoriasis in Greece. Results of this survey could assist in delineation of patient profiles, and improve communication between doctors and patients.

MDR-1 and MRP2 Gene Polymorphisms in Mexican Epileptic Pediatric Patients with Complex Partial Seizures.

PubMed

Escalante-Santiago, David; Feria-Romero, Iris Angélica; Ribas-Aparicio, Rosa María; Rayo-Mares, Dario; Fagiolino, Pietro; Vázquez, Marta; Escamilla-Núñez, Consuelo; Grijalva-Otero, Israel; López-García, Miguel Angel; Orozco-Suárez, Sandra

2014-01-01

Although the Pgp efflux transport protein is overexpressed in resected tissue of patients with epilepsy, the presence of polymorphisms in MDR1/ABCB1 and MRP2/ABCC2 in patients with antiepileptic-drugs resistant epilepsy (ADR) is controversial. The aim of this study was to perform an exploratory study to identify nucleotide changes and search new and reported mutations in patients with ADR and patients with good response (CTR) to antiepileptic drugs (AEDs) in a rigorously selected population. We analyzed 22 samples In Material and Methods, from drug-resistant patients with epilepsy and 7 samples from patients with good response to AEDs. Genomic DNA was obtained from leukocytes. Eleven exons in both genes were genotyped. The concentration of drugs in saliva and plasma was determined. The concentration of valproic acid in saliva was lower in ADR than in CRT. In ABCB1, five reported SNPs and five unreported nucleotide changes were identified; rs2229109 (GA) and rs2032582 (AT and AG) were found only in the ADR. Of six SNPs associated with the ABCC2 that were found in the study population, rs3740066 (TT) and 66744T > A (TG) were found only in the ADR. The strongest risk factor in the ABCB1 gene was identified as the TA genotype of rs2032582, whereas for the ABCC2 gene the strongest risk factor was the T allele of rs3740066. The screening of SNPs in ACBC1 and ABCC2 indicates that the Mexican patients with epilepsy in this study display frequently reported ABCC1 polymorphisms; however, in the study subjects with a higher risk factor for drug resistance, new nucleotide changes were found in the ABCC2 gene. Thus, the population of Mexican patients with AED-resistant epilepsy (ADR) used in this study exhibits genetic variability with respect to those reported in other study populations; however, it is necessary to explore this polymorphism in a larger population of patients with ADR.

MDR-1 and MRP2 Gene Polymorphisms in Mexican Epileptic Pediatric Patients with Complex Partial Seizures

PubMed Central

Escalante-Santiago, David; Feria-Romero, Iris Angélica; Ribas-Aparicio, Rosa María; Rayo-Mares, Dario; Fagiolino, Pietro; Vázquez, Marta; Escamilla-Núñez, Consuelo; Grijalva-Otero, Israel; López-García, Miguel Angel; Orozco-Suárez, Sandra

2014-01-01

Although the Pgp efflux transport protein is overexpressed in resected tissue of patients with epilepsy, the presence of polymorphisms in MDR1/ABCB1 and MRP2/ABCC2 in patients with antiepileptic-drugs resistant epilepsy (ADR) is controversial. The aim of this study was to perform an exploratory study to identify nucleotide changes and search new and reported mutations in patients with ADR and patients with good response (CTR) to antiepileptic drugs (AEDs) in a rigorously selected population. We analyzed 22 samples In Material and Methods, from drug-resistant patients with epilepsy and 7 samples from patients with good response to AEDs. Genomic DNA was obtained from leukocytes. Eleven exons in both genes were genotyped. The concentration of drugs in saliva and plasma was determined. The concentration of valproic acid in saliva was lower in ADR than in CRT. In ABCB1, five reported SNPs and five unreported nucleotide changes were identified; rs2229109 (GA) and rs2032582 (AT and AG) were found only in the ADR. Of six SNPs associated with the ABCC2 that were found in the study population, rs3740066 (TT) and 66744T > A (TG) were found only in the ADR. The strongest risk factor in the ABCB1 gene was identified as the TA genotype of rs2032582, whereas for the ABCC2 gene the strongest risk factor was the T allele of rs3740066. The screening of SNPs in ACBC1 and ABCC2 indicates that the Mexican patients with epilepsy in this study display frequently reported ABCC1 polymorphisms; however, in the study subjects with a higher risk factor for drug resistance, new nucleotide changes were found in the ABCC2 gene. Thus, the population of Mexican patients with AED-resistant epilepsy (ADR) used in this study exhibits genetic variability with respect to those reported in other study populations; however, it is necessary to explore this polymorphism in a larger population of patients with ADR. PMID:25346718

Patient compliance with managed care emergency department referral: an orthopaedic view.

PubMed

Saroff, Don; Dell, Rick; Brown, E Richard

2002-04-01

Patient compliance with emergency department (ED)-generated referral is an important part of the delivery of quality health care. Although many studies from non-managed care health centers have reported on ED patient compliance, no studies have reported on this in a managed care setting. The objective of this study is to examine patient compliance with ED-generated referral and to produce a benchmark of follow-up rates possible in a capitated managed care system. That is to say, in a health care system whose members pay a uniform per capita payment or fee, one that has salaried physicians, owns its own hospitals, and has a mechanism of transition from ED to outpatient clinic that ensures referral accessibility. Retrospective review of consecutive ED patient compliance with ED-generated referral. All consecutive patients who presented to a managed care hospital's ED with an acute fracture and who were given an outpatient referral during the period from 23rd December 1998 to 23rd January, 1999. Of 8000 consecutive ED patients, 234 were included in the study. Compliance with ED-generated referral was determined from outpatient clinic records. Of the 234 patients treated in the ED and referred, 222 (94.9%) complied with follow-up appointments. We have demonstrated that an ED patient follow-up compliance rate of 94.9% can be obtained. It is probable that the high compliance rate is due to the features of the system studied. The high rate may also be related to the specific diagnosis studied, although previous literature reports poor ED patient compliance for the same diagnosis in a different ED setting. Additional research is needed to determine whether the high compliance rate reported in this study can be obtained in ED settings that are not part of a similar managed care system and to determine the role of referral accessibility (or inaccessibility) in current ED settings.

Hearing aid patients in private practice and public health (Veterans Affairs) clinics: are they different?

PubMed

Cox, Robyn M; Alexander, Genevieve C; Gray, Ginger A

2005-12-01

In hearing aid research, it is commonplace to combine data across subjects whose hearing aids were provided in different service delivery models. There is reason to question whether these types of patients are always similar enough to justify this practice. To explore this matter, this investigation evaluated similarities and differences in self-report data obtained from hearing aid patients derived from public health (Veterans Affairs, VA) and private practice (PP) settings. The study was a multisite, cross-sectional survey in which 230 hearing aid patients from VA and PP audiology clinic settings provided self-report data on a collection of questionnaires both before and after the hearing aid fitting. Subjects were all older adults with mild to moderately severe hearing loss. About half of them had previous experience wearing hearing aids. All subjects were fitted with wide-dynamic-range-compression instruments and received similar treatment protocols. Numerous statistically significant differences were observed between the VA and PP subject groups. Before the fitting, VA patients reported higher expectations from the hearing aids and more severe unaided problems compared with PP patients with similar audiograms. Three wks after the fitting, VA patients reported more satisfaction with their hearing aids. On some measures VA patients reported more benefit, but different measures of benefit did not give completely consistent results. Both groups reported using the hearing aids an average of approximately 8 hrs per day. VA patients reported age-normal physical and mental health, but PP patients tended to report better than typical health for their age group. These data indicate that hearing aid patients seen in the VA public health hearing services are systematically different in self-report domains from those seen in private practice services. It is therefore risky to casually combine data from these two types of subjects or to generalize research results from one group to the other. Further, compared with PP patients, VA patients consistently reported more favorable hearing aid fitting outcomes. Additional study is indicated to explore the determinants of this result and its generalizability to other public health service delivery systems such as those in other countries. Moreover, efforts should be made to assess the potential for transferring positive elements from the VA system to the PP service delivery system, if possible.

Learning disabilities in Darier's disease patients.

PubMed

Dodiuk-Gad, R; Lerner, M; Breznitz, Z; Cohen-Barak, E; Ziv, M; Shani-Adir, A; Amichai, B; Zlotogorski, A; Shalev, S; Rozenman, D

2014-03-01

Neuropsychiatric features and intellectual difficulties have been reported in studies of Darier's disease. Learning disabilities have never been reported or evaluated systematically in these patients. To assess the prevalence of learning disabilities in 76 patients with Darier's disease, and cognitive functioning in 19 of them. The data were collected by two methods: a questionnaire, as part of a larger study on the clinical characteristics of 76 patients; and neuropsychological measures for the assessment of learning disabilities in 19 of them. Thirty-one of the 76 patients reported learning disabilities (41%) and 56 (74%) reported a family history of learning disabilities. Significant differences were found between the 19 patients evaluated on cognitive tasks and a control group of 42 skilled learners on subtraction and multiplication tasks. Six (32%) of the 19 were identified as having reading difficulties and five (26%) exhibited low performance on the Concentration Performance Test. All patients had general cognitive ability in the average range. Findings suggest an association between Darier's disease and learning disabilities, a heretofore unreported association, pointing to the need to obtain personal and family history of such disabilities in order to refer cases of clinical concern for further study. © 2013 The Authors Journal of the European Academy of Dermatology and Venereology © 2013 European Academy of Dermatology and Venereology.

A clinical observational study on patient-reported outcomes, hip functional performance and return to sports activities in hip arthroscopy patients.

PubMed

Tijssen, Marsha; van Cingel, Robert; de Visser, Enrico; Nijhuis-van der Sanden, Maria

2016-07-01

To describe data of short- and midterm results of hip arthroscopy patients based on patient-reported hip function, hip functional performance and return to sports activities. Observational cohort study. Sports medical center. 37 recreational athletes (21 men) at least six months after finishing rehabilitation for hip arthroscopy. International Hip Outcome Tool 33 (IHOT-33), Pain Visual Analogue Scale (VAS), Global Perceived Effect Scale (GPE), sports questionnaires and hip functional performance tests. At a mean follow-up time of 2.3 years, 81% of participants reported improvement on the GPE and 84% returned to sports activities. The mean IHOT-33 score was 69.3; the mean VAS score was 35.0. Range of motion (ROM) and strength were within the 90% Limb Symmetry Index (LSI) limit, except for hip internal rotation ROM. A full recovery of hip functional performance, as measured with balance and hop tests, was established based on the 90% LSI limit. The overall short- and midterm results of these follow-up data show good recovery of hip arthroscopy patients on patient-reported outcomes, functional performance and return to sports activities. The functional performance tests used in this study seem adequate for measuring recovery in hip arthroscopy patients. Copyright © 2016 Elsevier Ltd. All rights reserved.

Quality of Reporting Nutritional Randomized Controlled Trials in Patients With Cystic Fibrosis.

PubMed

Daitch, Vered; Babich, Tanya; Singer, Pierre; Leibovici, Leonard

2016-08-01

Randomized controlled trials (RCTs) have a major role in the making of evidence-based guidelines. The aim of the present study was to critically appraise the RCTs that addressed nutritional interventions in patients with cystic fibrosis. Embase, PubMed, and the Cochrane Library were systematically searched until July 2015. Methodology and reporting of nutritional RCTs were evaluated by the Consolidated Standards of Reporting Trials (CONSORT) checklist and additional dimensions relevant to patients with CF. Fifty-one RCTs were included. Full details on methods were provided in a minority of studies. The mean duration of intervention was <6 months. 56.9% of the RCTs did not define a primary outcome; 70.6% of studies did not provide details on sample size calculation; and only 31.4% reported on the subgroup or separated between important subgroups. The examined RCTs were characterized by a weak methodology, a small number of patients with no sample size calculations, a relatively short intervention, and many times did not examine the outcomes that are important to the patient. Improvement over the years has been minor.

The value of bedside shift reporting enhancing nurse surveillance, accountability, and patient safety.

PubMed

Jeffs, Lianne; Acott, Ashley; Simpson, Elisa; Campbell, Heather; Irwin, Terri; Lo, Joyce; Beswick, Susan; Cardoso, Roberta

2013-01-01

A study was undertaken to explore nurses' experiences and perceptions associated with implementation of bedside nurse-to-nurse shift handoff reporting. Interviews were conducted with nurses and analyzed using directed content analysis. Two themes emerged that illustrated the value of bedside shift reporting. These themes included clarifying information and intercepting errors and visualizing patients and prioritizing care. Nurse leaders can leverage study findings in their efforts to embed nurse-to-nurse bedside shift reporting in their respective organizations.

Reducing Suicidal Ideation in Home Health Care: Results from the CAREPATH Depression Care Management Trial

PubMed Central

Lohman PhD, Matthew C.; Raue PhD, Patrick J.; Greenberg, Rebecca L.; Bruce, Martha L.

2016-01-01

Objectives The study evaluated the effectiveness of a depression care management intervention in reducing suicidal ideation (SI) among home health patients. Methods Data come from the cluster-randomized effectiveness trial of the Depression Care for Patients at Home (Depression CAREPATH), an intervention that integrates depression care management into the routine nursing visits of Medicare home health patients screening positive for depression. Patients were interviewed at baseline, 3, 6, and 12 months follow-up. Suicidal ideation was measured using the Hamilton Rating Scale for Depression (HAM-D) item. We compared likelihood of any level of SI between intervention and usual care patients using longitudinal logistic mixed-effects models. Results A total of 306 eligible patients enrolled in the trial. Among them, 70 patients (22.9%) reported SI at baseline. Among patients with SI, patients under the care of nurses randomized to CAREPATH were less likely to report SI over the study period (OR=0.51, 95% CI; 0.24-1.07), with 63.6% of usual care versus 31.3% of CAREPATH participants continuing to report SI after one year. Baseline major depression, greater perceived burdensomeness, and greater functional disability were associated with greater likelihood of SI. Conclusion SI is reported in more than 10% of Medicare home health patients. The Depression CAREPATH intervention was associated with a reduction in patients reporting SI at one year, compared to enhanced usual care. Given relative low burden on nursing staff, depression care management may be an important component of routine home health practices producing long-term reduction in SI among high-risk patients. PMID:26552852

The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis.

PubMed

Rolfes, Leàn; van Hunsel, Florence; van der Linden, Laura; Taxis, Katja; van Puijenbroek, Eugène

2017-07-01

Clinical information is needed to assess the causal relationship between a drug and an adverse drug reaction (ADR) in a reliable way. Little is known about the level of relevant clinical information about the ADRs reported by patients. The aim was to determine to what extent patients report relevant clinical information about an ADR compared with their healthcare professional. A retrospective analysis of all ADR reports on the same case, i.e., cases with a report from both the patient and the patient's healthcare professional, selected from the database of the Dutch Pharmacovigilance Center Lareb, was conducted. The extent to which relevant clinical information was reported was assessed by trained pharmacovigilance assessors, using a structured tool. The following four domains were assessed: ADR, chronology, suspected drug, and patient characteristics. For each domain, the proportion of reported information in relation to information deemed relevant was calculated. An average score of all relevant domains was determined and categorized as poorly (≤45%), moderately (from 46 to 74%) or well (≥75%) reported. Data were analyzed using a paired sample t test and Wilcoxon signed rank test. A total of 197 cases were included. In 107 cases (54.3%), patients and healthcare professionals reported a similar level of clinical information. Statistical analysis demonstrated no overall differences between the groups (p = 0.126). In a unique study of cases of ADRs reported by patients and healthcare professionals, we found that patients report clinical information at a similar level as their healthcare professional. For an optimal pharmacovigilance, both healthcare professionals and patient should be encouraged to report.

Methodological and ethical challenges in studying patients' perceptions of coercion: a systematic mixed studies review.

PubMed

Soininen, Päivi; Putkonen, Hanna; Joffe, Grigori; Korkeila, Jyrki; Välimäki, Maritta

2014-06-04

Despite improvements in psychiatric inpatient care, patient restrictions in psychiatric hospitals are still in use. Studying perceptions among patients who have been secluded or physically restrained during their hospital stay is challenging. We sought to review the methodological and ethical challenges in qualitative and quantitative studies aiming to describe patients' perceptions of coercive measures, especially seclusion and physical restraints during their hospital stay. Systematic mixed studies review was the study method. Studies reporting patients' perceptions of coercive measures, especially seclusion and physical restraints during hospital stay were included. Methodological issues such as study design, data collection and recruitment process, participants, sampling, patient refusal or non-participation, and ethical issues such as informed consent process, and approval were synthesized systematically. Electronic searches of CINALH, MEDLINE, PsychINFO and The Cochrane Library (1976-2012) were carried out. Out of 846 initial citations, 32 studies were included, 14 qualitative and 18 quantitative studies. A variety of methodological approaches were used, although descriptive and explorative designs were used in most cases. Data were mainly collected in qualitative studies by interviews (n = 13) or in quantitative studies by self-report questionnaires (n = 12). The recruitment process was explained in 59% (n = 19) of the studies. In most cases convenience sampling was used, yet five studies used randomization. Patient's refusal or non-participation was reported in 37% (n = 11) of studies. Of all studies, 56% (n = 18) had reported undergone an ethical review process in an official board or committee. Respondents were informed and consent was requested in 69% studies (n = 22). The use of different study designs made comparison methodologically challenging. The timing of data collection (considering bias and confounding factors) and the reasons for non-participation of eligible participants are likewise methodological challenges, e.g. recommended flow charts could aid the information. Other challenges identified were the recruitment of large and representative samples. Ethical challenges included requesting participants' informed consent and respecting ethical procedures.

Patient Drug Safety Reporting: Diabetes Patients' Perceptions of Drug Safety and How to Improve Reporting of Adverse Events and Product Complaints.

PubMed

Patel, Puja; Spears, David; Eriksen, Betina Østergaard; Lollike, Karsten; Sacco, Michael

2018-03-01

Global health care manufacturer Novo Nordisk commissioned research regarding awareness of drug safety department activities and potential to increase patient feedback. Objectives were to examine patients' knowledge of pharmaceutical manufacturers' responsibilities and efforts regarding drug safety, their perceptions and experiences related to these efforts, and how these factors influence their thoughts and behaviors. Data were collected before and after respondents read a description of a drug safety department and its practices. We conducted quantitative survey research across 608 health care consumers receiving treatment for diabetes in the United States, Germany, United Kingdom, and Italy. This research validated initial, exploratory qualitative research (across 40 comparable consumers from the same countries) which served to guide design of the larger study. Before reading a drug safety department description, 55% of respondents were unaware these departments collect safety information on products and patients. After reading the description, 34% reported the department does more than they expected to ensure drug safety, and 56% reported "more confidence" in the industry as a whole. Further, 66% reported themselves more likely to report an adverse event or product complaint, and 60% reported that they were more likely to contact a drug safety department with questions. The most preferred communication methods were websites/online forums (39%), email (27%), and telephone (25%). Learning about drug safety departments elevates consumers' confidence in manufacturers' safety efforts and establishes potential for patients to engage in increased self-monitoring and reporting. Study results reveal potentially actionable insights for the industry across patient and physician programs and communications.

Psychological impact of unexpected explicit recall of events occurring during surgery performed under sedation, regional anaesthesia, and general anaesthesia: data from the Anesthesia Awareness Registry.

PubMed

Kent, C D; Mashour, G A; Metzger, N A; Posner, K L; Domino, K B

2013-03-01

Anaesthetic awareness is a recognized complication of general anaesthesia (GA) and is associated with post-traumatic stress disorder (PTSD). Although complete amnesia for intraprocedural events during sedation and regional anaesthesia (RA) may occur, explicit recall is expected by anaesthesia providers. Consequently, the possibility that there could be psychological consequences associated with unexpected explicit recall of events during sedation and RA has not been investigated. This study investigated the psychological sequelae of unexpected explicit recall of events during sedation/RA that was reported to the Anesthesia Awareness Registry. The Registry recruited subjects who self-identified as having had anaesthetic awareness. Inclusion criteria were a patient-reported awareness experience in 1990 or later and availability of medical records. The sensations experienced by the subjects during their procedure and the acute and persistent psychological sequelae attributed to this explicit recall were assessed for patients receiving sedation/RA and those receiving GA. Among the patients fulfilling the inclusion criteria, medical record review identified 27 sedation/RA and 50 GA cases. Most patients experienced distress (78% of sedation/RA vs 94% of GA). Approximately 40% of patients with sedation/RA had persistent psychological sequelae, similar to GA patients. Some sedation/RA patients reported an adverse impact on their job performance (15%), family relationships (11%), and friendships (11%), and 15% reported being diagnosed with PTSD. Patients who self-reported to the Registry unexpected explicit recall of events during sedation/RA experienced distress and persistent psychological sequelae comparable with those who had reported anaesthetic awareness during GA. Further study is warranted to determine if patients reporting distress with explicit recall after sedation/RA require psychiatric follow-up.

Patient reported outcome of adult perioperative anaesthesia in the United Kingdom: a cross-sectional observational study.

PubMed

Walker, E M K; Bell, M; Cook, T M; Grocott, M P W; Moonesinghe, S R

2016-06-12

Understanding the patient perspective on healthcare is central to the evaluation of quality. This study measured selected patient-reported outcomes after anaesthesia in order to identify targets for research and quality improvement. This cross-sectional observational study in UK National Health Service hospitals, recruited adults undergoing non-obstetric surgery requiring anaesthesia care over a 48 h period. Within 24 h of surgery, patients completed the Bauer questionnaire (measuring postoperative discomfort and satisfaction with anaesthesia care), and a modified Brice questionnaire to elicit symptoms suggestive of accidental awareness during general anaesthesia (AAGA). Patient, procedural and pharmacological data were recorded to enable exploration of risk factors for these poor outcomes. 257 hospitals in 171 NHS Trusts participated (97% of eligible organisations). Baseline characteristics were collected on 16,222 patients; 15,040 (93%) completed postoperative questionnaires. Anxiety was most frequently cited as the worst aspect of the perioperative experience. Thirty-five per cent of patients reported severe discomfort in at least one domain: thirst (18.5%; 95% CI 17.8-19.1), surgical pain (11.0%; 10.5-11.5) and drowsiness (10.1%; 9.6-10.5) were most common. Despite this, only 5% reported dissatisfaction with any aspect of anaesthesia-related care. Regional anaesthesia was associated with a reduced burden of side-effects. The incidence of reported AAGA was one in 800 general anaesthetics (0.12%) Anxiety and discomfort after surgery are common; despite this, satisfaction with anaesthesia care in the UK is high. The inconsistent relationship between patient-reported outcome, patient experience and patient satisfaction supports using all three of these domains to provide a comprehensive assessment of the quality of anaesthesia care. © The Author 2016. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Targeted therapies and adverse drug reactions in oncology: the role of clinical pharmacist in pharmacovigilance.

PubMed

Fornasier, G; Taborelli, M; Francescon, S; Polesel, J; Aliberti, M; De Paoli, P; Baldo, P

2018-05-21

Background The majority of adverse drug reactions (ADRs) reported in the summary of product characteristics (SPCs) are based on pivotal clinical trials, performed under controlled conditions and with selected patients. Objectives (1) to observe ADRs in the real-world setting and to evaluate if the supervision of the pharmacist impacts on the management of ADRs and on the satisfaction of patients; (2) to sensitise health professionals and patients on the need to increase the reporting of ADRs, in compliance with Pharmacovigilance. Setting CRO Aviano, Italian National Cancer Institute. Method From February 2013 to April 2015, we conducted an observational study enrolling 154 patients (≥ 18 years) undergoing treatment with at least one of ten targeted-therapies included in the study. Main outcome ADR reporting in the real-world setting. Patient satisfaction with clinical pharmacist support. Results Reported ADRs in the real setting do not always correspond with data described in the respective SPCs. Unknown ADRs were also identified such as hyperglycaemia with lenalidomide and sorafenib; and hypomagnesaemia with bevacizumab. We also observed a 124.3% increase in spontaneous reports. Conclusion This study shows the high value of active pharmacovigilance programs, and our results might be a starting point for developing a randomised trial which should aim to demonstrate the impact of the pharmacist on improving patient's adherence and in measuring the difference in ADRs reports in the different arms followed or not by the pharmacist.

Patient positioning and ventilator-associated pneumonia.

PubMed

Hess, Dean R

2005-07-01

Rotational beds, prone position, and semi-recumbent position have been proposed as procedures to prevent ventilator-associated pneumonia (VAP). Rotational therapy uses a special bed designed to turn continuously, or nearly continuously, the patient from side to side; specific designs include kinetic therapy and continuous lateral rotation therapy. A meta-analysis of studies evaluating the effect of rotational bed therapy shows a decrease in the risk of pneumonia but no effect on mortality. Two studies reported a lower risk of VAP in patients placed in a prone position, with no effect on mortality. Studies using radiolabeled enteral feeding solutions in mechanically ventilated patients have reported that aspiration of gastric contents occurs to a greater degree when patients are in the supine position, compared with the semirecumbent position. One study reported a lower rate of VAP in patients randomized to semi-recumbent compared to supine position. Although each of the techniques discussed in this paper has been shown to reduce the risk of VAP, none has been shown to affect mortality. The available evidence suggests that semi-recumbent position should be used routinely, rotational therapy should be considered in selected patients, and prone position should not be used as a technique to reduce the risk of VAP.

Nonoperative Management of Craniocervical Ligamentous Distraction Injury: Literature Review.

PubMed

Kaplan, Nathan B; Molinari, Christine; Molinari, Robert W

2015-12-01

Study Design Literature review and case report. Objective Review the existing literature and report the successful nonoperative management of a two-level craniocervical ligamentous distraction injury. Methods A PubMed and Medline review revealed only three limited reports involving the nonoperative management of patients with craniocervical distraction injury. This article reviews the existing literature and reports the case of a 27-year-old man who was involved in a motorcycle accident and sustained multiple systemic injuries and ligamentous distraction injuries to both occipitocervical joints and both C1-C2 joints. The patient's traumatic brain injury and bilateral pulmonary contusions precluded safe operative management of the two-level craniocervical distraction injury. Therefore, the patient was placed in a halo immobilization device. Results The literature remains unclear as to the specific indications for nonoperative management of ligamentous craniocervical injuries. Nonoperative management was associated with poor outcomes in the majority of reported patients. We report a patient who was managed for 6 months in a halo device. Posttreatment computed tomography and flexion-extension radiographs demonstrated stable occipitocervical and C1-C2 joints bilaterally. The patient reported minimal neck pain and had excellent functional outcome with a Neck Disability Index score of 2 points at 41 months postoperatively. He returned to preinjury level of employment without restriction. Conclusions Further study is needed to determine which craniocervical injuries may be managed successfully with nonoperative measures.

Nonoperative Management of Craniocervical Ligamentous Distraction Injury: Literature Review

PubMed Central

Kaplan, Nathan B.; Molinari, Christine; Molinari, Robert W.

2015-01-01

Study Design Literature review and case report. Objective Review the existing literature and report the successful nonoperative management of a two-level craniocervical ligamentous distraction injury. Methods A PubMed and Medline review revealed only three limited reports involving the nonoperative management of patients with craniocervical distraction injury. This article reviews the existing literature and reports the case of a 27-year-old man who was involved in a motorcycle accident and sustained multiple systemic injuries and ligamentous distraction injuries to both occipitocervical joints and both C1–C2 joints. The patient's traumatic brain injury and bilateral pulmonary contusions precluded safe operative management of the two-level craniocervical distraction injury. Therefore, the patient was placed in a halo immobilization device. Results The literature remains unclear as to the specific indications for nonoperative management of ligamentous craniocervical injuries. Nonoperative management was associated with poor outcomes in the majority of reported patients. We report a patient who was managed for 6 months in a halo device. Posttreatment computed tomography and flexion–extension radiographs demonstrated stable occipitocervical and C1–C2 joints bilaterally. The patient reported minimal neck pain and had excellent functional outcome with a Neck Disability Index score of 2 points at 41 months postoperatively. He returned to preinjury level of employment without restriction. Conclusions Further study is needed to determine which craniocervical injuries may be managed successfully with nonoperative measures. PMID:26682101

Transcutaneous Drainage of Gel-Like Substance after Application of Hydrogel Dural Sealant: Report of Two Cases.

PubMed

Siman, Homayoun; Techy, Fernando

2016-02-01

Study Design Case report. Objective Incidental durotomy (IDT) is a common complication of spinal surgery. The use of collagen matrix graft along with hydrogel dural sealant is a common method of IDT repair. With this method, there have been several reported cases of detrimental dural sealant expansion in the literature. One case study reported an expansion rate greater than 300%; many report neurologic damage. This article reports the clinical course of two patients who developed postoperative transcutaneous drainage of a gel-like substance after the use of a dural sealant, which is a previously unreported complication. Methods The clinical course and treatment outcome of two patients is presented. Results Both patients experienced postoperative transcutaneous drainage of a gel-like substance at the surgical site. Case one began draining this substance on postoperative day 14. This patient required no further intervention, and the drainage ended after 3 mL of a gel-like substance was expressed from his incision while in the clinic. Case two began draining the gel on postoperative day 16. This patient underwent two washout procedures and resolution of the drainage. No infection was ever detected. Conclusions To our knowledge, our patients are the first reported cases of transcutaneous drainage of expanded dural sealant. It is important to take into consideration the unexpected expansion of a dural sealant when using it for the repair of IDT.

Transcutaneous Drainage of Gel-Like Substance after Application of Hydrogel Dural Sealant: Report of Two Cases

PubMed Central

Siman, Homayoun; Techy, Fernando

2015-01-01

Study Design Case report. Objective Incidental durotomy (IDT) is a common complication of spinal surgery. The use of collagen matrix graft along with hydrogel dural sealant is a common method of IDT repair. With this method, there have been several reported cases of detrimental dural sealant expansion in the literature. One case study reported an expansion rate greater than 300%; many report neurologic damage. This article reports the clinical course of two patients who developed postoperative transcutaneous drainage of a gel-like substance after the use of a dural sealant, which is a previously unreported complication. Methods The clinical course and treatment outcome of two patients is presented. Results Both patients experienced postoperative transcutaneous drainage of a gel-like substance at the surgical site. Case one began draining this substance on postoperative day 14. This patient required no further intervention, and the drainage ended after 3 mL of a gel-like substance was expressed from his incision while in the clinic. Case two began draining the gel on postoperative day 16. This patient underwent two washout procedures and resolution of the drainage. No infection was ever detected. Conclusions To our knowledge, our patients are the first reported cases of transcutaneous drainage of expanded dural sealant. It is important to take into consideration the unexpected expansion of a dural sealant when using it for the repair of IDT. PMID:26835216

Global Variability in Reported Mortality for Critical Illness during the 2009-10 Influenza A(H1N1) Pandemic: A Systematic Review and Meta-Regression to Guide Reporting of Outcomes during Disease Outbreaks.

PubMed

Duggal, Abhijit; Pinto, Ruxandra; Rubenfeld, Gordon; Fowler, Robert A

2016-01-01

To determine how patient, healthcare system and study-specific factors influence reported mortality associated with critical illness during the 2009-2010 Influenza A (H1N1) pandemic. Systematic review with meta-regression of studies reporting on mortality associated with critical illness during the 2009-2010 Influenza A (H1N1) pandemic. Medline, Embase, LiLACs and African Index Medicus to June 2009-March 2016. 226 studies from 50 countries met our inclusion criteria. Mortality associated with H1N1-related critical illness was 31% (95% CI 28-34). Reported mortality was highest in South Asia (61% [95% CI 50-71]) and Sub-Saharan Africa (53% [95% CI 29-75]), in comparison to Western Europe (25% [95% CI 22-30]), North America (25% [95% CI 22-27]) and Australia (15% [95% CI 13-18]) (P<0.0001). High income economies had significantly lower reported mortality compared to upper middle income economies and lower middle income economies respectively (P<0.0001). Mortality for the first wave was non-significantly higher than wave two (P = 0.66). There was substantial variability in reported mortality among the specific subgroups of patients: unselected critically ill adults (27% [95% CI 24-30]), acute respiratory distress syndrome (37% [95% CI 32-44]), acute kidney injury (44% [95% CI 26-64]), and critically ill pregnant patients (10% [95% CI 5-19]). Reported mortality for outbreaks and pandemics may vary substantially depending upon selected patient characteristics, the number of patients described, and the region and economic status of the outbreak location. Outcomes from a relatively small number of patients from specific regions may lead to biased estimates of outcomes on a global scale.

An observational study of agreement between percentage pain reduction calculated from visual analog or numerical rating scales versus that reported by parturients during labor epidural analgesia.

PubMed

Pratici, E; Nebout, S; Merbai, N; Filippova, J; Hajage, D; Keita, H

2017-05-01

This study aimed to determine the level of agreement between calculated percentage pain reduction, derived from visual analog or numerical rating scales, and patient-reported percentage pain reduction in patients having labor epidural analgesia. In a prospective observational study, parturients were asked to rate their pain intensity on a visual analog scale and numerical rating scale, before and 30min after initiation of epidural analgesia. The percentage pain reduction 30min after epidural analgesia was calculated by the formula: 100×(score before epidural analgesia-score 30min after epidural analgesia)/score before epidural analgesia. To evaluate agreement between calculated percentage pain reduction and patient-reported percentage pain reduction, we computed the concordance correlation coefficient and performed Bland-Altman analysis. Ninety-seven women in labor were enrolled in the study, most of whom were nulliparous, with a singleton fetus and in spontaneous labor. The concordance correlation coefficient with patient-reported percentage pain reduction was 0.76 (95% CI 0.6 to 0.8) and 0.77 (95% CI 0.6 to 0.8) for the visual analog and numerical rating scale, respectively. The Bland-Altman mean difference between calculated percentage pain reduction and patient-reported percentage pain reduction for the visual analog and numerical rating scales was -2.0% (limits of agreement at 29.8%) and 0 (limits of agreement at 28.2%), respectively. The agreement between calculated percentage pain reduction from a visual analog or numerical rating scale and patient-reported percentage pain reduction in the context of labor epidural analgesia was moderate. The difference could range up to 30%. Patient-reported percentage pain reduction has advantages as a measurement tool for assessing pain management for childbirth but differences compared with other assessment methods should be taken into account. Copyright © 2017 Elsevier Ltd. All rights reserved.

Fluid Extravasation in Hip Arthroscopy: A Systematic Review.

PubMed

Ekhtiari, Seper; Haldane, Chloe E; de Sa, Darren; Simunovic, Nicole; Ayeni, Olufemi R

2017-04-01

The purpose of this systematic review was to (1) characterize cases of fluid extravasation during hip arthroscopy and explore common factors among them and (2) describe management strategies and outcomes of this complication. The databases MEDLINE, EMBASE, and PubMed were searched and screened in duplicate. Data regarding patient demographics, fluid management, presentation, management, and outcomes were collected. Study quality was assessed in duplicate using the Methodological Index for Non-Randomized Studies Criteria. Fourteen studies (1,286 patients) were included. Twenty-two occurrences of symptomatic fluid extravasation were reported in 21 patients (1.6% of total patients; one patient had fluid extravasation during 2 separate hip arthroscopies). Two studies of normal fluid extravasation in asymptomatic patients reported 1.13 to 3.06 L of extravasated fluid observed on computed tomography. Nine case studies were included, which provided detailed patient and surgical information. Of these 9 patients (10 cases) with a mean age of 38.2 years old (range, 15 to 55 years), 6 were female. Signs of fluid extravasation included abdominal distension (89%), hypothermia (56%), hypotension. and metabolic acidosis (33% each). Four patients required surgical intervention, while 3 underwent paracentesis. Two patients were managed conservatively. All patients stabilized and were discharged, with one patient reporting abdominal complaints at latest follow-up (length of follow-up unspecified). Fluid extravasation is a rare but potentially life-threatening complication of hip arthroscopy. It is important for surgeons and anaesthesiologists to be aware of its existence in order to recognize and manage it promptly. Most patients require interventional management by surgery or paracentesis, but some stabilize with conservative management. Level IV, systematic review of Level IV studies. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Appearance vs. health reasons for seeking treatment among obese patients with binge eating disorder.

PubMed

Reas, Deborah L; Masheb, Robin M; Grilo, Carlos M

2004-05-01

This study examined reasons for seeking treatment reported by obese patients diagnosed with binge eating disorder (BED). Participants were 248 adults (58 men and 190 women) who met DSM criteria for BED. Participants were recruited through advertisements for treatment studies looking for persons who wanted to "stop binge eating and lose weight." Patients' reasons for seeking treatment were examined with respect to demography (gender and age), obesity (BMI and age of onset), features of eating disorders, and associated psychological functioning (depression and self-esteem). Of the 248 participants, 64% reported health concerns and 36% reported appearance concerns as their primary reason for seeking treatment. Reasons for seeking treatment did not differ significantly by gender. Patients seeking treatment because of appearance-related reasons had lower BMIs than those reporting health-related reasons (34.8 vs. 38.5, respectively), but they reported greater body dissatisfaction, more features of eating disorders, and lower self-esteem. Reasons that prompt treatment seeking among obese individuals with BED reflect meaningful patient characteristics and, therefore, warrant assessment and consideration during treatment planning. Further research is needed to determine whether reasons for treatment seeking among different obese patient groups affect treatment outcomes. Copyright 2004 NAASO

Safety and Efficacy of Lacrimal Drainage System Plugs for Dry Eye Syndrome: A Report by the American Academy of Ophthalmology.

PubMed

Marcet, Marcus M; Shtein, Roni M; Bradley, Elizabeth A; Deng, Sophie X; Meyer, Dale R; Bilyk, Jurij R; Yen, Michael T; Lee, W Barry; Mawn, Louise A

2015-08-01

To review the published literature assessing the efficacy and safety of lacrimal drainage system plug insertion for dry eye in adults. Literature searches of the PubMed and Cochrane Library databases were last conducted on March 9, 2015, without date restrictions and were limited to English language abstracts. The searches retrieved 309 unique citations. The primary authors reviewed the titles and abstracts. Inclusion criteria specified reports that provided original data on plugs for the treatment of dry eyes in at least 25 patients. Fifty-three studies of potential relevance were assigned to full-text review. The 27 studies that met the inclusion criteria underwent data abstraction by the panels. Abstracted data included study characteristics, patient characteristics, plug type, insertion technique, treatment response, and safety information. All studies were observational and rated by a methodologist as level II or III evidence. The plugs included punctal, intracanalicular, and dissolving types. Fifteen studies reported metrics of improvement in dry eye symptoms, ocular-surface status, artificial tear use, contact lens comfort, and tear break-up time. Twenty-five studies included safety data. Plug placement resulted in ≥50% improvement of symptoms, improvement in ocular-surface health, reduction in artificial tear use, and improved contact lens comfort in patients with dry eye. Serious complications from plugs were infrequent. Plug loss was the most commonly reported problem with punctal plugs, occurring on average in 40% of patients. Overall, among all plug types, approximately 9% of patients experienced epiphora and 10% required removal because of irritation from the plugs. Canaliculitis was the most commonly reported problem for intracanalicular plugs and occurred in approximately 8% of patients. Other complications were reported in less than 4% of patients on average and included tearing, discomfort, pyogenic granuloma, and dacryocystitis. On the basis of level II and III evidence in these studies, plugs improve the signs and symptoms of moderate dry eye that are not improved with topical lubrication, and they are well tolerated. There are no level I studies that describe the efficacy or safety of lacrimal drainage system plugs. Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Rate and predictors of negative effects of psychotherapy in psychiatric and psychosomatic inpatients.

PubMed

Rheker, Julia; Beisel, Sylvia; Kräling, Svenja; Rief, Winfried

2017-08-01

Studies examining the rates of negative effects of psychotherapy are rare and the reported rates differ widely. To be able to calculate adequate benefit-cost ratios in conjunction with different samples and settings, we need a deeper understanding of these effects. We therefore investigated whether different treatment settings would reveal varying rates and kinds of negative effects by recruiting patients from a psychiatric (n=93) and a psychosomatic rehabilitation (n=63) hospital. Negative effects of psychotherapy were assessed with the Inventory for the Assessment of Negative Effects of Psychotherapy post-treatment. To investigate whether patients' pre-treatment expectations have an influence on reported negative effects, patients filled in the Patient Questionnaire on Therapy Expectation and Evaluation prior to treatment begin. Patients from the psychiatric hospital reported an average 1.41 negative effects, with 58.7% reporting at least one negative effect. Those from the psychosomatic hospital reported 0.76 negative effects on average, with 45.2% of patients reporting at least one negative effect. The differences between these samples are significant. The two samples' top three reported types of negative effects are that patients had experienced more downs during or just before the end of the therapy, that patients had difficulty making important decisions without the therapist, and that patients were concerned that colleagues or friends might find out about the therapy. A regression analysis revealed that the clinical setting (psychosomatic rehabilitation hospital vs. psychiatric hospital) and expectations in the form of hope of improvement were significant predictors for negative effects of psychotherapy. Our study highlights the need to examine the negative effects of psychotherapy in different settings and samples to better evaluate the benefit-cost ratios of treatments for different patient groups. It also shows that we need guidelines for assessing and reporting negative effects. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Patient-reported access to primary care in Ontario: effect of organizational characteristics.

PubMed

Muggah, Elizabeth; Hogg, William; Dahrouge, Simone; Russell, Grant; Kristjansson, Elizabeth; Muldoon, Laura; Devlin, Rose Anne

2014-01-01

To describe patient-reported access to primary health care across 4 organizational models of primary care in Ontario, and to explore how access is associated with patient, provider, and practice characteristics. Cross-sectional survey. One hundred thirty-seven randomly selected primary care practices in Ontario using 1 of 4 delivery models (fee for service, established capitation, reformed capitation, and community health centres). Patients included were at least 18 years of age, were not severely ill or cognitively impaired, were not known to the survey administrator, had consenting providers at 1 of the participating primary care practices, and were able to communicate in English or French either directly or through a translator. Patient-reported access was measured by a 4-item scale derived from the previously validated adult version of the Primary Care Assessment Tool. Questions were asked about physician availability during and outside of regular office hours and access to health information via telephone. Responses to the scale were normalized, with higher scores reflecting greater patient-reported access. Linear regressions were used to identify characteristics independently associated with access to care. Established capitation model practices had the highest patient-reported access, although the difference in scores between models was small. Our multilevel regression model identified several patient factors that were significantly (P = .05) associated with higher patient-reported access, including older age, female sex, good-to-excellent self-reported health, less mental health disability, and not working. Provider experience (measured as years since graduation) was the only provider or practice characteristic independently associated with improved patient-reported access. This study adds to what is known about access to primary care. The study found that established capitation models outperformed all the other organizational models, including reformed capitation models, independent of provider and practice variables save provider experience. This suggests that the capitation models might provide better access to care and that it might take time to realize the benefits of organizational reforms.

Treatment of dissociative disorders and reported changes in inpatient and outpatient cost estimates.

PubMed

Myrick, Amie C; Webermann, Aliya R; Langeland, Willemien; Putnam, Frank W; Brand, Bethany L

2017-01-01

Background: Interpersonal trauma and trauma-related disorders cost society billions of dollars each year. Because of chronic and severe trauma histories, dissociative disorder (DD) patients spend many years in the mental health system, yet there is limited knowledge about the economic burden associated with DDs. Objective: The current study sought to determine how receiving specialized treatment would relate to estimated costs of inpatient and outpatient mental health services. Method: Patients' and individual therapists' reports of inpatient hospitalization days and outpatient treatment sessions were converted into US dollars. DD patients and their clinicians reported on use of inpatient and outpatient services four times over 30 months as part of a larger, naturalistic, international DD treatment study. The baseline sample included 292 clinicians and 280 patients; at the 30-month follow-up, 135 clinicians and 111 patients. Missing data were replaced in analyses to maintain adequate statistical power. The substantial attrition rate (>50%) should be considered in interpreting findings. Results: Longitudinal and cross-sectional analyses of cost estimates based on patient reported inpatient hospitalization significantly decreased over time. Longitudinal cost estimates based on clinician-reported outpatient services also significantly decreased over time. Cross-sectional cost estimates based on patient and clinician reported inpatient hospitalization were significantly lower for patients in later stages of treatment compared to those struggling with safety and stabilization. Cross-sectional cost estimates based on clinician-reported outpatient services were significantly lower for patients in later stages of treatment compared to those in early stages. Conclusions: This pattern of longitudinal and cross-sectional reductions in inpatient and outpatient costs, as reported by both patients and therapists, suggests that DD treatment may be associated with reduced inpatient and outpatient costs over time. Although these preliminary results show decreased mental health care utilization and associated estimated costs, it is not clear whether it was treatment that caused these important changes.

A prospective cohort study investigating the effect of generalized joint hypermobility on outcomes after arthroscopic anterior shoulder stabilization.

PubMed

Koyonos, Loukas; Kraeutler, Matthew J; O'Brien, Daniel F; Ciccotti, Michael G; Dodson, Christopher C

2016-11-01

Generalized joint laxity has been proposed as a significant risk factor for failure after arthroscopic anterior shoulder stabilization. The purpose of this study was to prospectively measure joint mobility in patients undergoing arthroscopic anterior shoulder stabilization and to determine whether hypermobility is a risk factor for worse outcomes compared with patients having normal joint mobility. Patients with anterior shoulder instability were prospectively enrolled. Generalized joint hypermobility was measured using the Beighton Hypermobility Score and the Rowe, UCLA, SANE, SST, and WOSI scores were administered and reported as patient outcomes preoperatively and following arthroscopic anterior shoulder stabilization at 6 weeks, 6 months, 12 months, and 24 months postoperatively. Patients were stratified into two groups based on their Beighton Hypermobility Score, with scores ≥ 4/9 indicative of joint hypermobility. Sixteen patients with joint hypermobility (JH) and 18 non-hypermobile patients (NJH) were enrolled. At baseline, there were no significant differences in demographic characteristics or baseline patient-reported outcomes. Significantly more patients in the NJH group had SLAP tears (n = 10) compared to the JH group (n = 2) (p = .013). At all follow-up times, there were no significant differences between the NJH and JH groups with regard to patient-reported outcome scores (p > .05). In the JH group, 17% of patients reported recurrent instability at two years postoperatively compared to 25% of patients in the NJH group. There was no significant difference in failure rate (p = .67). There was no significant difference in patient-reported outcomes or recurrent instability in patients with versus without joint hypermobility undergoing arthroscopic anterior shoulder stabilization.

Lack of diversity in orthopaedic trials conducted in the United States.

PubMed

Somerson, Jeremy S; Bhandari, Mohit; Vaughan, Clayton T; Smith, Christopher S; Zelle, Boris A

2014-04-02

Several orthopaedic studies have suggested patient race and ethnicity to be important predictors of patient functional outcomes. This issue has also been emphasized by federal funding sources. However, the reporting of race and ethnicity has gained little attention in the orthopaedic literature. The objective of this study was to determine the percentage of orthopaedic randomized controlled clinical trials in the United States that included race and ethnicity data and to record the racial and ethnic distribution of patients enrolled in these trials. A systematic review of orthopaedic randomized controlled trials published from 2008 to 2011 was performed. The studies were identified through a manual search of thirty-two scientific journals, including all major orthopaedic journals as well as five leading medical journals. Only trials from the United States were included. The publication date, journal impact factor, orthopaedic subspecialty, ZIP code of the primary research site, number of enrolled patients, type of funding, and race and ethnicity of the study population were extracted from the identified studies. A total of 158 randomized controlled trials with 37,625 enrolled patients matched the inclusion criteria. Only thirty-two studies (20.3%) included race or ethnicity with at least one descriptor. Government funding significantly increased the likelihood of reporting these factors (p < 0.05). The percentages of Hispanic and African-American patients were extractable for studies with 7648 and 6591 enrolled patients, respectively. In those studies, 4.6% (352) of the patients were Hispanic and 6.2% (410) were African-American; these proportions were 3.5-fold and twofold lower, respectively, than those represented in the 2010 United States Census. Few orthopaedic randomized controlled trials performed in the United States reported data on race or ethnicity. Among trials that did report demographic race or ethnicity data, the inclusion of minority patients was substantially lower than would be expected on the basis of census demographics. Failure to represent the true racial diversity may result in decreased generalizability of trial conclusions across clinical populations.

Indications and Outcomes for Microfracture as an Adjunct to Hip Arthroscopy for Treatment of Chondral Defects in Patients With Femoroacetabular Impingement: A Systematic Review.

PubMed

MacDonald, Austin E; Bedi, Asheesh; Horner, Nolan S; de Sa, Darren; Simunovic, Nicole; Philippon, Marc J; Ayeni, Olufemi R

2016-01-01

To evaluate the indications, preoperative workup outcomes, and postoperative rehabilitation of patients with femoroacetabular impingement (FAI) receiving microfracture as an adjunct to hip arthroscopy for chondral defects. The electronic databases MEDLINE, EMBASE, and PubMed were searched and screened in duplicate for studies involving patients with FAI treated arthroscopically with microfracture of the hip for chondral defects either solely or as an adjunct to hip arthroscopy. Data regarding indications, investigations, outcomes, and postoperative rehabilitation were abstracted from eligible studies. The references of included studies were additionally searched, and descriptive statistics are provided. There were 12 studies included in this review, involving 267 patients. With the exception of a single, one-patient case report, 11 of the 12 studies reported positive outcomes after hip arthroscopy with microfracture. Only 0.7% of the total patients experienced a complication, and 1.1% required further surgery on the basis of outcomes evaluated at a mean follow-up of 29.5 (range, 4 to 60) months across the studies. Eight of 12 studies discussed the preoperative workup of these patients, with X-rays and magnetic resonance imaging being the most common preoperative imaging used. There was little reported on weight-bearing status during postoperative rehabilitation. The outcomes reported in the literature after hip arthroscopy with microfracture for chondral defects are, in general, positive, with a very low percentage of patients requiring further surgery or experiencing complications. The most common indication used in the literature for microfracture is a full-thickness, focal chondral defect (Outerbridge grade IV). The vast majority of literature recommends limited weight bearing after microfracture; however, there was significant variation among the specific rehabilitation protocols used. More research is needed to explore what indications and postoperative rehabilitation result in the best outcomes for patients. Level IV, systematic review of Level II, III, and IV studies. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Who are medical marijuana patients? Population characteristics from nine California assessment clinics.

PubMed

Reinarman, Craig; Nunberg, Helen; Lanthier, Fran; Heddleston, Tom

2011-01-01

Marijuana is a currently illegal psychoactive drug that many physicians believe has substantial therapeutic uses. The medical literature contains a growing number of studies on cannabinoids as well as case studies and anecdotal reports suggesting therapeutic potential. Fifteen states have passed medical marijuana laws, but little is known about the growing population of patients who use marijuana medicinally. This article reports on a sample of 1,746 patients from a network of nine medical marijuana evaluation clinics in California. Patients completed a standardized medical history form; evaluating physicians completed standardized evaluation forms. From this data we describe patient characteristics, self-reported presenting symptoms, physician evaluations, other treatments tried, other drug use, and medical marijuana use practices. Pain, insomnia, and anxiety were the most common conditions for which evaluating physicians recommended medical marijuana. Shifts in the medical marijuana patient population over time, the need for further research, and the issue of diversion are discussed.

Patient participation in quality pain management during an acute care admission.

PubMed

McTier, Lauren J; Botti, Mari; Duke, Maxine

2014-04-01

The objective of the study was to explore patient participation in the context of pain management during a hospital admission for a cardiac surgical intervention of patients with cardiovascular disease. This is a single-institution study, with a case-study design. The unit of analysis was a cardiothoracic ward of a major metropolitan, tertiary referral hospital in Melbourne, Australia. Multiple methods of data collection were used including preadmission and predischarge patient interviews (n=98), naturalistic observations (n=48), and focus group interviews (n=2). Patients' preference for participation in pain management was not always commensurate with their involvement in pain management. Patients displayed a greater understanding of their role in pain management in terms of reporting pain and the use of multimodal analgesics after surgery. The majority of patients, however, did not understand the importance of reporting pain to avoid complications. Patients had limited opportunity to participate in their pain management. On occasions in which clinicians did involve patients, the involvement appeared to be focused on reporting pain rather than treatment of pain. Patient participation in pain management during hospitalization is not optimal. This has implications for the quality of pain management patients receive. Higher engagement of patients in their pain management during hospitalization is required to ensure comfort, reduce potential for complications, and adequately prepare the patients to manage their pain following discharge from hospital.

Long-term safety profile of anakinra in patients with severe cryopyrin-associated periodic syndromes

PubMed Central

Löfqvist, Malin; Leinonen, Mika; Goldbach-Mansky, Raphaela; Olivecrona, Hans

2016-01-01

Objective. Anakinra is approved for the treatment of RA and cryopyrin-associated periodic syndromes (CAPS). While the anakinra safety profile is well established in RA, the long-term safety profile in severe CAPS is less well documented and will therefore be discussed in this report. Methods. A prospective, open-label, single centre, clinical cohort study was conducted at the National Institutes of Health in the USA, from 2003 to 2010, investigating the efficacy and safety of anakinra treatment for up to 5 years in 43 patients with CAPS. Safety was evaluated using adverse event (AE) reports, laboratory assessments, vital signs and diary reports. Results. In total, 1233 AEs were reported during the study, with a yearly rate of 7.7 AEs per patient. The event rate decreased over time, and dose escalation during the study did not affect AE frequency. Anakinra had similar safety profiles in adults and children. The most frequently reported AEs were typical CAPS disease symptoms such as headache and arthralgia. Injection site reactions occurred mainly during the first month of anakinra treatment. In total, 14 patients experienced 24 serious AEs (SAEs), all of which resolved during the study period. The most common types of SAEs were infections such as pneumonia and gastroenteritis. There were no permanent discontinuations of treatment due to AEs. Conclusion. In this study anakinra treatment of patients with severe CAPS for up to 5 years was safe and well tolerated both in paediatric and adult patients, with most AEs emerging during the first months after treatment initiation. Trial registration: ClincialTrials.gov, clinicaltrials.gov, NCT00069329 PMID:27143789

Patients' Awareness, Usage and Impact of Hospital Report Cards in the US.

PubMed

Emmert, Martin; Schlesinger, Mark

2017-12-01

Little knowledge is available about the importance of hospital report cards in the US from the patients' perspective. It also remains unknown whether specific report cards with a stronger emphasis on clinical measures have a greater impact on hospital choice than general report cards that focus on online-derived ratings. The aim of this study was to determine the awareness and usage of hospital report cards as well as their impact on hospital choice in the US. We conducted a cross-sectional study by surveying a stratified online sample (N = 1332) to ensure representativeness to the US online population (February 2015). Overall, 75% of all respondents (mean age 45.4 years; 54% female) were aware of hospital report cards. Among these, 56% had used a report card to search for a hospital, and 80% of report card users stated having been influenced by a report card. Both the awareness and usage of general report cards were shown to be higher than for specific report cards. No significant differences could be detected regarding the impact between general or specific report cards on hospital choice. Our results indicate that hospital report cards play a considerable role among patients when searching for a hospital in the US; however, patients do not seem to have a preference regarding the type of report cards they use when selecting a hospital.

Evaluation of Patient and Family Engagement Strategies to Improve Medication Safety.

PubMed

Kim, Julia M; Suarez-Cuervo, Catalina; Berger, Zackary; Lee, Joy; Gayleard, Jessica; Rosenberg, Carol; Nagy, Natalia; Weeks, Kristina; Dy, Sydney

2018-04-01

Patient and family engagement (PFE) is critical for patient safety. We systematically reviewed types of PFE strategies implemented and their impact on medication safety. We searched MEDLINE, EMBASE, reference lists and websites to August 2016. Two investigators independently reviewed all abstracts and articles, and articles were additionally reviewed by two senior investigators for selection. One investigator abstracted data and two investigators reviewed the data for accuracy. Study quality was determined by consensus. Investigators developed a framework for defining the level of patient engagement: informing patients about medications (Level 1), informing about engagement with health care providers (Level 2), empowering patients with communication tools and skills (Level 3), partnering with patients in their care (Level 4), and integrating patients as full care team members (Level 5). We included 19 studies that mostly targeted older adults taking multiple medications. The median level of engagement was 2, ranging from 2-4. We identified no level 5 studies. Key themes for patient engagement strategies impacting medication safety were patient education and medication reconciliation, with a subtheme of patient portals. Most studies (84%) reported implementation outcomes. The most commonly reported medication safety outcomes were medication errors, including near misses and discrepancies (47%), and medication safety knowledge (37%). Most studies (63%) were of medium to low quality, and risk of bias was generally moderate. Among the 11 studies with control groups, 55% (n = 6) reported statistically significant improvement on at least one medication safety outcome. Further synthesis of medication safety measures was limited due to intervention and outcome heterogeneity. Key strategies for engaging patients in medication safety are education and medication reconciliation. Patient engagement levels were generally low, as defined by a novel framework for determining levels of patient engagement. As more patient engagement studies are conducted, this framework should be evaluated for associations with patient outcomes.

The perspective of healthcare providers and patients on health literacy: a systematic review of the quantitative and qualitative studies.

PubMed

Rajah, Retha; Ahmad Hassali, Mohamed Azmi; Jou, Lim Ching; Murugiah, Muthu Kumar

2018-03-01

Health literacy (HL) is a multifaceted concept, thus understanding the perspective of healthcare providers, patients, and the system is vital. This systematic review examines and synthesises the available studies on HL-related knowledge, attitude, practice, and perceived barriers. CINAHL and Medline (via EBSCOhost), Google Scholar, PubMed, ProQuest, Sage Journals, and Science Direct were searched. Both quantitative and/or qualitative studies in the English language were included. Intervention studies and studies focusing on HL assessment tools and prevalence of low HL were excluded. The risk of biasness reduced with the involvement of two reviewers independently assessing study eligibility and quality. A total of 30 studies were included, which consist of 19 quantitative, 9 qualitative, and 2 mixed-method studies. Out of 17 studies, 13 reported deficiency of HL-related knowledge among healthcare providers and 1 among patients. Three studies showed a positive attitude of healthcare providers towards learning about HL. Another three studies demonstrated patients feel shame exposing their literacy and undergoing HL assessment. Common HL communication techniques reported practiced by healthcare providers were the use of everyday language, teach-back method, and providing patients with reading materials and aids, while time constraint was the most reported HL perceived barriers by both healthcare providers and patients. Significant gaps exists in HL knowledge among healthcare providers and patients that needs immediate intervention. Such as, greater effort placed in creating a health system that provides an opportunity for healthcare providers to learn about HL and patients to access health information with taking consideration of their perceived barriers.

Strategies to use tablet computers for collection of electronic patient-reported outcomes.

PubMed

Schick-Makaroff, Kara; Molzahn, Anita

2015-01-22

Mobile devices are increasingly being used for data collection in research. However, many researchers do not have experience in collecting data electronically. Hence, the purpose of this short report was to identify issues that emerged in a study that incorporated electronic capture of patient-reported outcomes in clinical settings, and strategies used to address the issues. The issues pertaining to electronic patient-reported outcome data collection were captured qualitatively during a study on use of electronic patient-reported outcomes in two home dialysis units. Fifty-six patients completed three surveys on tablet computers, including the Kidney Disease Quality of Life-36, the Edmonton Symptom Assessment Scale, and a satisfaction measure. Issues that arose throughout the research process were recorded during ethics reviews, implementation process, and data collection. Four core issues emerged including logistics of technology, security, institutional and financial support, and electronic design. Although use of mobile devices for data collection has many benefits, it also poses new challenges for researchers. Advance consideration of possible issues that emerge in the process, and strategies that can help address these issues, may prevent disruption and enhance validity of findings.

Detection and prevention of medication misadventures in general practice.

PubMed

Tam, Ka Wae Tammy; Kwok, Kon Hung; Fan, Yuen Man Cecilia; Tsui, Kwok Biu; Ng, Kwok Keung; Ho, King Yip Anthony; Lau, Kam Tong; Chan, Yuk Chun; Tse, Ching Wan Charmaine; Lau, Cheuk Man

2008-06-01

Adverse drug events are leading categories of iatrogenic patient injury. Development of preventive strategies for general practice setting depends on effective detection of events. The aim of the study is to compare the strengths and weaknesses of voluntary reporting, chart review and patient survey in measuring medication misadventures in general practice and to analyze the events by severity and preventability, drug groups and patients' and doctors' characteristics, for the formulation of preventive strategies. In the 2-month study period, we applied voluntary report, chart review and patient survey to collect data related to medication misadventures and compared their detection rate. The chart review demonstrated the highest yield for detecting overall medication misadventures (2.03% medication orders), followed by patient survey (1.46% medication orders) and voluntary reporting (0.52% medication orders). Chart review and patient survey were better than voluntary reporting in uncovering preventable adverse drug events. However, voluntary reporting was pivotal in capturing sentinel events. Beta-blocker, diuretic, angiotensin-converting enzyme inhibitor, aspirin and non-steroidal anti-inflammatory drugs had caused 82.0% of all adverse drug events. These events were more common with advanced age of patients, greater number of consultation problems and prescribed drug items. Additional resources implicated were minimal. We suggested a complementary approach using chart review and voluntary reporting in measuring and monitoring medication misadventures in general practice. Close monitoring of the events was necessary for older patients, multiple medical problems and poly-pharmacy and for patients using beta-blocker, diuretic, angiotensin-converting enzyme inhibitor, aspirin or non-steroidal anti-inflammatory drugs on a long-term basis.

Concurrent insulinoma with mosaic Turner syndrome: A case report.

PubMed

Wang, Shaoyun; Yang, Lijuan; Li, Jie; Mu, Yiming

2015-03-01

Turner syndrome is a chromosomal abnormality in which the majority of patients have a 45XO karyotype, while a small number have a 45XO/47XXX karyotype. Congenital adrenal hyperplasia has been previously reported in patients with Turner syndrome. Although insulinomas are the most common type of functioning pancreatic neuroendocrine tumor and have been reported in patients with multiple endocrine neoplasias, the tumors have not been reported in patients with mosaic Turner syndrome. The present study reports the first case of an insulinoma in a patient with 45XO/47XXX mosaic Turner syndrome. The patient suffered from recurrent hypoglycemia, which was relieved following ingestion of glucose or food. A 5-h glucose tolerance test was performed and the levels of glucose, C-Peptide and insulin were detected. In addition, computed tomography (CT) and ultrasound scanning were performed to evaluate the possibility of an insulinoma. Pathological examination and karyotyping were performed on a surgical specimen and a whole blood sample, respectively. The patient was found to suffer from premature ovarian failure, and a physical examination was consistent with a diagnosis of Turner syndrome. An ultrasound scan demonstrated streak ovaries and the patient was found to have a 45XO/47XXX karyotype. Furthermore, a lesion was detected in the pancreas following CT scanning, which was identified as an insulinoma following surgical removal and histological examination. In conclusion, the present study reports the first case of an insulinoma in a patient with mosaic Turner syndrome. Since mosaic Turner syndrome and insulinoma are rare diseases, an association may exist that has not been previously identified.

Do the filarial lymphoedema patients''3 months recall' on acute dermato-lymphangio-adenitis (ADLA) correlate with streptococcal serology?

PubMed

De Britto, L J; Das, L K

2012-08-01

The aim of this study was to know the correlation of patients' 3 months recall on acute dermato-lymphangio-adenitis (ADLA) with anti-streptolysin O (ASO) serology and its application as a tool to know the burden of ADLA in the community. Fifty-nine lymphoedema (LE) patients and 27 age matched controls were clinically assessed for LE and the occurrence of ADLA during the previous 3 months was obtained by recall. After obtaining the informed consent, 2 mL of venous blood sample was collected and ASO was quantified in Olympus AU400 auto-analyzer. When the results were computed as two groups, controls and LE patients with no reported ADLA and LE patients with reported ADLA (by 3 months recall), the ASO positivity and ASO titre was significantly higher in the later group (P < 0.05). When the results were computed as three groups, controls with no reported ADLA, LE patients with no reported ADLA and LE patients with reported ADLA, the ASO titre was significantly higher in LE patients reported ADLA (P < 0.05). As ASO was measured in post-infection phase, we relied on the ASO titre for making conclusion. Patients' 3 months recall on ADLA correlates with the ASO titre and therefore, it could be considered as a tool to measure the burden of ADLA in the community. Multicentre community-based studies are needed to ascertain the findings. © 2011 The Authors. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology.

Challenge of assessing symptoms in seriously ill intensive care unit patients: can proxy reporters help?

PubMed

Puntillo, Kathleen A; Neuhaus, John; Arai, Shoshana; Paul, Steven M; Gropper, Michael A; Cohen, Neal H; Miaskowski, Christine

2012-10-01

Determine levels of agreement among intensive care unit patients and their family members, nurses, and physicians (proxies) regarding patients' symptoms and compare levels of mean intensity (i.e., the magnitude of a symptom sensation) and distress (i.e., the degree of emotionality that a symptom engenders) of symptoms among patients and proxy reporters. Prospective study of proxy reporters of symptoms in seriously ill patients. Two intensive care units in a tertiary medical center in the Western United States. Two hundred and forty-five intensive care unit patients, 243 family members, 103 nurses, and 92 physicians. None. On the basis of the magnitude of intraclass correlation coefficients, where coefficients from .35 to .78 are considered to be appropriately robust, correlation coefficients between patients' and family members' ratings met this criterion (≥.35) for intensity in six of ten symptoms. No intensity ratings between patients and nurses had intraclass correlation coefficients >.32. Three symptoms had intensity correlation coefficients of ≥.36 between patients' and physicians' ratings. Correlation coefficients between patients and family members were >.40 for five symptom-distress ratings. No symptoms had distress correlation coefficients of ≥.28 between patients' and nurses' ratings. Two symptoms had symptom-distress correlation coefficients between patients' and physicians' ratings at >.39. Family members, nurses, and physicians reported higher symptom-intensity scores than patients did for 80%, 60%, and 60% of the symptoms, respectively. Family members, nurses, and physicians reported higher symptom-distress scores than patients did for 90%, 70%, and 80% of the symptoms, respectively. Patient-family intraclass correlation coefficients were sufficiently close for us to consider using family members to help assess intensive care unit patients' symptoms. Relatively low intraclass correlation coefficients between intensive care unit clinicians' and patients' symptom ratings indicate that some proxy raters overestimate whereas others underestimate patients' symptoms. Proxy overestimation of patients' symptom scores warrants further study because this may influence decisions about treating patients' symptoms.

Frequency of reporting on patient and public involvement (PPI) in research studies published in a general medical journal: a descriptive study.

PubMed

Price, Amy; Schroter, Sara; Snow, Rosamund; Hicks, Melissa; Harmston, Rebecca; Staniszewska, Sophie; Parker, Sam; Richards, Tessa

2018-03-23

While documented plans for patient and public involvement (PPI) in research are required in many grant applications, little is known about how frequently PPI occurs in practice. Low levels of reported PPI may mask actual activity due to limited PPI reporting requirements. This research analysed the frequency and types of reported PPI in the presence and absence of a journal requirement to include this information. A before and after comparison of PPI reported in research papers published in The BMJ before and 1 year after the introduction of a journal policy requiring authors to report if and how they involved patients and the public within their papers. Between 1 June 2013 and 31 May 2014, The BMJ published 189 research papers and 1 (0.5%) reported PPI activity. From 1 June 2015 to 31 May 2016, following the introduction of the policy, The BMJ published 152 research papers of which 16 (11%) reported PPI activity. Patients contributed to grant applications in addition to designing studies through to coauthorship and participation in study dissemination. Patient contributors were often not fully acknowledged; 6 of 17 (35%) papers acknowledged their contributions and 2 (12%) included them as coauthors. Infrequent reporting of PPI activity does not appear to be purely due to a failure of documentation. Reporting of PPI activity increased after the introduction of The BMJ 's policy, but activity both before and after was low and reporting was inconsistent in quality. Journals, funders and research institutions should collaborate to move us from the current situation where PPI is an optional extra to one where PPI is fully embedded in practice throughout the research process. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Gamma knife radiosurgery for typical trigeminal neuralgia: An institutional review of 108 patients

PubMed Central

Elaimy, Ameer L.; Lamm, Andrew F.; Demakas, John J.; Mackay, Alexander R.; Lamoreaux, Wayne T.; Fairbanks, Robert K.; Pfeffer, Robert D.; Cooke, Barton S.; Peressini, Benjamin J.; Lee, Christopher M.

2013-01-01

Background: In this study, we present the previously unreported pain relief outcomes of 108 patients treated at Gamma Knife of Spokane for typical trigeminal neuralgia (TN) between 2002 and 2011. Methods: Pain relief outcomes were measured using the Barrow Neurological Institute (BNI) pain intensity scale. In addition, the effects gender, age at treatment, pain laterality, previous surgical treatment, repeat Gamma Knife radiosurgery (GKRS), and maximum radiosurgery dose have on patient pain relief outcomes were retrospectively analyzed. Statistical analysis was performed using Andersen 95% confidence intervals, approximate confidence intervals for log hazard ratios, and multivariate Cox proportional hazard models. Results: All 108 patients included in this study were grouped into BNI class IV or V prior to GKRS. The median clinical follow-up time was determined to be 15 months. Following the first GKRS procedure, 71% of patients were grouped into BNI class I-IIIb (I = 31%; II = 3%; IIIa = 19%; IIIb = 18%) and the median duration of pain relief for those patients was determined to be 11.8 months. New facial numbness was reported in 19% of patients and new facial paresthesias were reported in 7% of patients after the first GKRS procedure. A total of 19 repeat procedures were performed on the 108 patients included in this study. Following the second GKRS procedure, 73% of patients were grouped into BNI class I-IIIb (I = 44%; II = 6%; IIIa = 17%, IIIb = 6%) and the median duration of pain relief for those patients was determined to be 4.9 months. For repeat procedures, new facial numbness was reported in 22% of patients and new facial paresthesias were reported in 6% of patients. Conclusions: GKRS is a safe and effective management approach for patients diagnosed with typical TN. However, further studies and supporting research is needed on the effects previous surgical treatment, number of radiosurgery procedures, and maximum radiosurgery dose have on GKRS clinical outcomes. PMID:23956935

A cross-sectional study to identify organisational processes associated with nurse-reported quality and patient safety

PubMed Central

Tvedt, Christine; Sjetne, Ingeborg Strømseng; Helgeland, Jon; Bukholm, Geir

2012-01-01

Objectives The purpose of this study was to identify organisational processes and structures that are associated with nurse-reported patient safety and quality of nursing. Design This is an observational cross-sectional study using survey methods. Setting Respondents from 31 Norwegian hospitals with more than 85 beds were included in the survey. Participants All registered nurses working in direct patient care in a position of 20% or more were invited to answer the survey. In this study, 3618 nurses from surgical and medical wards responded (response rate 58.9). Nurses' practice environment was defined as organisational processes and measured by the Nursing Work Index Revised and items from Hospital Survey on Patient Safety Culture. Outcome measures Nurses' assessments of patient safety, quality of nursing, confidence in how their patients manage after discharge and frequency of adverse events were used as outcome measures. Results Quality system, nurse–physician relation, patient safety management and staff adequacy were process measures associated with nurse-reported work-related and patient-related outcomes, but we found no associations with nurse participation, education and career and ward leadership. Most organisational structures were non-significant in the multilevel model except for nurses’ affiliations to medical department and hospital type. Conclusions Organisational structures may have minor impact on how nurses perceive work-related and patient-related outcomes, but the findings in this study indicate that there is a considerable potential to address organisational design in improvement of patient safety and quality of care. PMID:23263021

Hip Arthroscopy in Patients Age 40 or Older: A Systematic Review.

PubMed

Horner, Nolan S; Ekhtiari, Seper; Simunovic, Nicole; Safran, Marc R; Philippon, Marc J; Ayeni, Olufemi R

2017-02-01

To (1) report clinical outcomes, complication rates, and total hip arthroplasty (THA) conversion rates for patients age 40 or older who underwent hip arthroscopy, and (2) report any age-related predictors of outcome identified in the literature. MEDLINE, EMBASE, and PubMed were searched for relevant studies and pertinent data were abstracted from eligible studies. No meta-analysis was performed because of heterogeneity amongst studies. Seventeen studies were included in this review comprising 16,327 patients, including 9,954 patients age 40 or older. All studies reported statistically significant improvements in outcomes after hip arthroscopy for femoral osteochondroplasty, labral repair, or unspecified indications. In patients 40 or older who underwent labral debridement, these improvements were not clinically significant. Obesity and osteoarthritic changes predicted poorer outcomes. Only 1 of 3 studies directly comparing the 2 groups found that patients 40 or older had a significantly less improvement in a standardized hip outcome score than patients under 40 after hip arthroscopy, but all found that patients 40 or older had significantly higher rates of THA conversion. The rate of conversion to THA was 18.1% for patients 40 or older, 23.1% for patients over 50, and 25.2% for patients over 60 with a mean of 25.0 months to THA. Indications for hip arthroscopy including femoral osteochondroplasty and labral repair resulted in clinically significant improvements in patients 40 or older in most research studies examined in this review, whereas labral debridement did not produce clinically significant improvements postoperatively in the same studies. In these studies, the rate of conversion to THA is higher than in patients under 40 and increases with each decade of life, with many individual studies showing a significant increase in the rate of THA conversion. Hip arthroscopy may be suitable for some patients 40 or older, but patient selection is key and patients should be informed of the higher risk of conversion to THA. Level IV, systematic review of Level III and IV studies. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Characteristics of patients with fibromyalgia in France and Germany.

PubMed

Perrot, S; Winkelmann, A; Dukes, E; Xu, X; Schaefer, C; Ryan, K; Chandran, A; Sadosky, A; Zlateva, G

2010-07-01

Few studies have comprehensively assessed the burden associated with fibromyalgia (FM). This cross-sectional, observational study evaluates the impact of FM on patients in France and Germany. A total of 299 FM patients were recruited from 33 physician offices in France and Germany during routine visits. Patients completed a survey that included the Brief Pain Inventory-Short Form (BPI-sf), Fibromyalgia Impact Questionnaire (FIQ), EuroQol 5D (EQ-5D) and the Hospital Anxiety and Depression Scale (HADS) to describe their pain, FM and health-related quality of life (HRQOL). FM severity was defined using patients' FIQ total scores with 0 to < 39, 39 to < 59 and 59-100, representing mild, moderate and severe FM, respectively. Site staff completed case report forms using patients' medical records. Mean (standard deviation, SD) age was 54.2 (12.6); 81% of patients were women. The mean (SD) FIQ total score was 53.3 (19.6); 33% and 44% of patients reported moderate and severe FM, respectively. Most patients (91%) were receiving prescription medications for FM during the study. Patients reported a mean (SD) EQ-5D health state valuation of 0.44 (0.33) and a mean (SD) BPI-sf Pain Severity Index score of 4.9 (1.8). Forty-one percent of patients reported some level of disruption in their employment because of FM; employed patients missed a mean (SD) of 2.2 (4.6) workdays during the past 4 weeks. An increase in FM severity was significantly associated with increased pain severity, productivity loss, sleep disturbance and higher anxiety and depression (p < 0.0001). There is a substantial burden of illness including treatment limitations for FM patients in France and Germany.

Understanding the Patient Experience with Carcinoid Syndrome: Exit Interviews from a Randomized, Placebo-controlled Study of Telotristat Ethyl.

PubMed

Anthony, Lowell; Ervin, Claire; Lapuerta, Pablo; Kulke, Matthew H; Kunz, Pamela; Bergsland, Emily; Hörsch, Dieter; Metz, David C; Pasieka, Janice; Pavlakis, Nick; Pavel, Marianne; Caplin, Martyn; Öberg, Kjell; Ramage, John; Evans, Emily; Yang, Qi Melissa; Jackson, Shanna; Arnold, Karie; Law, Linda; DiBenedetti, Dana B

2017-11-01

Telotristat ethyl, an oral tryptophan hydroxylase inhibitor, is intended to treat carcinoid syndrome by reducing serotonin production. Telotristat ethyl was evaluated in TELESTAR, a Phase III study for patients who had carcinoid syndrome with at least 4 bowel movements (BMs) per day and who were receiving somatostatin analogue therapy. This interview substudy was conducted to provide insight into the patient experience in TELESTAR and to help understand whether reductions in BM frequency (the primary end point) and other symptoms were clinically meaningful. Participating sites were asked to invite (before randomization) all eligible patients to telephone interviews scheduled at the end of the double-blind treatment period. Patients and interviewers were blinded to treatment. All 35 interviewed participants reported diarrhea and/or excessive BMs at baseline. Patients reported that these symptoms negatively affected emotional, social, physical, and occupational well-being. Prespecified criteria for treatment response (achieving ≥30% reduction in BM frequency for at least 50% of the days) were met by 8 of 26 patients taking telotristat ethyl and 1 of 9 patients taking placebo. All 8 patients taking telotristat ethyl described clinically meaningful reductions in BM frequency and were very satisfied with the ability of the study drug to control their carcinoid syndrome symptoms. Overall, reports of being very satisfied were observed in 12 patients taking telotristat ethyl and 0 taking placebo. Patient interviews revealed that TELESTAR patients, at baseline, were significantly affected by their high BM frequency. Patient reports of their clinical trial experience supported the significance of the primary end point and clinical responder analysis in TELESTAR, helping identify and understand clinically meaningful change produced by telotristat ethyl. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Neurosyphilis in Africa: A systematic review.

PubMed

Marks, Michael; Jarvis, Joseph N; Howlett, William; Mabey, David C W

2017-08-01

Neurological involvement is one of the most important clinical manifestations of syphilis and neurological disease occurs in both early and late syphilis. The impact of HIV co-infection on clinical neurosyphilis remains unclear. The highest prevalence of both syphilis and HIV is in Africa. Therefore it might be expected that neurosyphilis would be an important and not uncommon manifestation of syphilis in Africa and frequently occur in association with HIV co-infection; yet few data are available on neurosyphilis in Africa. The aim of this study is to review data on neurosyphilis in Africa since the onset of the HIV epidemic. We searched the literature for references on neurosyphilis in Africa for studies published between the 1st of January 1990 and 15th February 2017. We included case reports, case series, and retrospective and prospective cohort and case-control studies. We did not limit inclusion based on the diagnostic criteria used for neurosyphilis. For retrospective and prospective cohorts, we calculated the proportion of study participants who were diagnosed with neurosyphilis according to the individual study criteria. Depending on the study, we assessed the proportion of patients with syphilis found to have neurosyphilis, and the proportion of patients with neurological syndromes who had neurosyphilis. Due to heterogeneity of data no formal pooling of the data or meta-analysis was undertaken. Amongst patients presenting with a neurological syndrome, three studies of patients with meningitis were identified; neurosyphilis was consistently reported to cause approximately 3% of all cases. Three studies on stroke reported mixed findings but were limited due to the small number of patients undergoing CSF examination, whilst neurosyphilis continued to be reported as a common cause of dementia in studies from North Africa. Ten studies reported on cases of neurosyphilis amongst patients known to have syphilis. Studies from both North and Southern Africa continue to report cases of late stage syphilis, including tabes dorsalis and neurosyphilis, in association with ocular disease. This is the first systematic review of the literature on neurosyphilis in Africa since the beginning of the HIV epidemic. Neurosyphilis continues to be reported as a manifestation of both early and late syphilis, but the methodological quality of the majority of the included studies was poor. Future well-designed prospective studies are needed to better delineate the incidence and clinical spectrum of neurosyphilis in Africa and to better define interactions with HIV in this setting.

EXERCISE AND STRESS MANAGEMENT TRAINING PRIOR TO HEMATOPOIETIC CELL TRANSPLANTATION: BLOOD AND MARROW TRANSPLANT CLINICAL TRIALS NETWORK (BMT CTN) 0902

PubMed Central

Jacobsen, Paul B.; Le-Rademacher, Jennifer; Jim, Heather; Syrjala, Karen; Wingard, John R.; Logan, Brent; Wu, Juan; Majhail, Navneet S.; Wood, William; Rizzo, J. Douglas; Geller, Nancy L.; Kitko, Carrie; Faber, Edward; Abidi, Muneer H.; Slater, Susan; Horowitz, Mary M.; Lee, Stephanie J.

2014-01-01

Studies show that engaging patients in exercise and/or stress management techniques during hematopoietic cell transplantation (HCT) improves quality of life. The Blood and Marrow Transplant Clinical Trials Network tested the efficacy of training patients to engage in self-directed exercise and stress management during their HCTs. The study randomized 711 patients at 21 centers to receive one of four training interventions before HCT: a self-directed exercise program, a self-administered stress management program, both or neither. Participants completed self-reported assessments at enrollment and up to 180 days after transplant. Randomization was stratified by center and transplant type. There were no differences in the primary endpoints of the physical (PCS) and mental (MCS) component scales of the SF36 at day 100 among the groups based on an intention-to-treat analysis. There were no differences observed in overall survival, hospital days through day 100 post-HCT, or in other patient-reported outcomes, including treatment-related distress, sleep quality, pain, and nausea. Patient randomized to training in stress management reported more use of those techniques; patients randomized to training in exercise did not report more physical activity. Although other studies have reported efficacy of more intensive interventions, brief training in an easy-to-disseminate format for either self-directed exercise or stress management was not effective in our trial. PMID:24910380

Automatic detection of rhythmic and periodic patterns in critical care EEG based on American Clinical Neurophysiology Society (ACNS) standardized terminology.

PubMed

Fürbass, F; Hartmann, M M; Halford, J J; Koren, J; Herta, J; Gruber, A; Baumgartner, C; Kluge, T

2015-09-01

Continuous EEG from critical care patients needs to be evaluated time efficiently to maximize the treatment effect. A computational method will be presented that detects rhythmic and periodic patterns according to the critical care EEG terminology (CCET) of the American Clinical Neurophysiology Society (ACNS). The aim is to show that these detected patterns support EEG experts in writing neurophysiological reports. First of all, three case reports exemplify the evaluation procedure using graphically presented detections. Second, 187 hours of EEG from 10 critical care patients were used in a comparative trial study. For each patient the result of a review session using the EEG and the visualized pattern detections was compared to the original neurophysiology report. In three out of five patients with reported seizures, all seizures were reported correctly. In two patients, several subtle clinical seizures with unclear EEG correlation were missed. Lateralized periodic patterns (LPD) were correctly found in 2/2 patients and EEG slowing was correctly found in 7/9 patients. In 8/10 patients, additional EEG features were found including LPDs, EEG slowing, and seizures. The use of automatic pattern detection will assist in review of EEG and increase efficiency. The implementation of bedside surveillance devices using our detection algorithm appears to be feasible and remains to be confirmed in further multicenter studies. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Patient-reported outcomes measured by BREAST-Q after implant-based breast reconstruction: A cross-sectional controlled study in Brazilian patients.

PubMed

Aguiar, Isabella de Carvalho; Veiga, Daniela Francescato; Marques, Thaline Figueiredo; Novo, Neil Ferreira; Sabino Neto, Miguel; Ferreira, Lydia Masako

2017-02-01

The purpose of this study was to assess patient-reported outcomes of breast reconstruction with implants, using the BREAST-Q, in the late postoperative period. A total of 114 women previously operated due to breast cancer, in the late postoperative period (range 6-24 months) were enrolled in this cross-sectional study, and were allocated to either the mastectomy group (MG, n = 57) or reconstruction group (RG, n = 57). Patients in MG and RG, respectively, completed the Brazilian versions of Mastectomy and Reconstruction Modules of the BREAST-Q. The mean age of patients was 46.6 and 44.3 years in MG and RG, respectively. All patients underwent chemotherapy and 6% and 11% of patients underwent radiotherapy in MG and RG, respectively. Patients in the RG reported higher satisfaction with surgical outcome (P < 0.0001). However, no significant between-group differences were found in physical and sexual well-being, or satisfaction with the plastic surgeon, medical team, and office staff. Breast reconstruction with implants increased patient satisfaction with the surgical outcome, but did not influence patients' physical and sexual well-being or their satisfaction with the treatment received. Copyright © 2016 Elsevier Ltd. All rights reserved.

Seizures and Epilepsy in Alzheimer’s Disease

PubMed Central

Friedman, Daniel; Honig, Lawrence S.; Scarmeas, Nikolaos

2013-01-01

Introduction Many studies have shown that patients with Alzheimer’s disease (AD) are at increased risk for developing seizures and epilepsy. However, reported prevalence and incidence of seizures and relationship of seizures to disease measures such as severity, outcome and progression vary widely between studies. Methods Literature review of the available clinical and epidemiological data on the topic of seizures in patients with AD. We review seizure rates and types, risk factors for seizures, electroencephalogram (EEG)studies, and treatment responses. Finally, we consider limitations and methodological issues. Results There is considerable variability in the reported prevalence and incidence of seizures in patients with AD - with reported lifetime prevalence rates of 1.5 - 64%. More recent, prospective, and larger studies in general report lower rates. Some, but not all, studies have noted increased seizure risk with increasing dementia severity or with younger age of AD onset. Generalized convulsive seizures are the most commonly reported type, but often historical information is the only basis used to determine seizure type and the manifestation of seizures may be difficult to distinguish from other behaviors common in demented patients. EEG has infrequently been performed and reported. Data on treatment of seizures in AD are extremely limited. Similarly, the relationship between seizures and cognitive impairment in AD is unclear. Conclusions The literature on seizures and epilepsy in AD, including diagnosis, risk factors, and response to treatment suffers from methodological limitations and gaps. PMID:22070283

How the Timing of a Patient's Self-ratings of Suicidality and the Relationship to the Recipient Affect Patient Responses: A Case Study.

PubMed

Giddens, Jennifer M; Sheehan, David V

2014-09-01

This case study explores to what extent, if any, a subject's reporting varies depending upon whom the subject believes will view the data and the relationship the subject has with the reviewer. It also explores the variance in reporting if several days pass between the timeframe in question and the time of data collection. The subject answered three suicidality-related scales (the Sheehan-Suicidality Tracking Scale, the Suicidality Modifiers, and the Alphs Dichotomous Impulsivity and Hopelessness Two Questions) for 24 distinct timeframes. The scales were rated three different ways for each timeframe. The first was for only the patient. Immediately afterward, the scales were answered for the subject's therapist. A few days later, the scales were again answered by the patient, but only for the patient. The three different interviews for the same timeframe were compared to investigate any deviations. This case study found clinically relevant deviations between the three ratings completed for the same timeframe. This case study illustrates that a patient's reporting of his or her symptoms of suicidality using a patient-rated scale can vary depending upon the context, distance from timeframe in question, and the patient's relationship with the reviewer of the data.

Phase II study of the immune-checkpoint inhibitor ipilimumab plus dacarbazine in Japanese patients with previously untreated, unresectable or metastatic melanoma.

PubMed

Yamazaki, N; Uhara, H; Fukushima, S; Uchi, H; Shibagaki, N; Kiyohara, Y; Tsutsumida, A; Namikawa, K; Okuyama, R; Otsuka, Y; Tokudome, T

2015-11-01

Ipilimumab (IPI), a monoclonal antibody against immune-checkpoint receptor cytotoxic T lymphocyte antigen-4, is designed to enhance antitumor T cell function. IPI 10 mg/kg plus dacarbazine (DTIC) significantly improved overall survival in a phase 3 study involving predominantly Caucasian patients, with an adverse event (AE) profile similar to that of IPI monotherapy. We conducted a single-arm, phase 2 study to evaluate the safety and efficacy of IPI plus DTIC in Japanese patients. Previously untreated patients with unresectable stage III or IV melanoma received IPI 10 mg/kg plus DTIC 850 mg/m(2) every 3 weeks for four doses (q3w × 4), followed by DTIC q3w × 4 and then IPI every 12 weeks until disease progression or intolerable toxicity. All 15 treated patients reported drug-related AEs, the most common of which were increases in alanine aminotransferase (n = 12, 80 %) and aspartate aminotransferase (n = 11, 73 %). Treatment-related serious AEs were reported in 11 (73 %) patients. Nine patients (60 %) discontinued treatment due to drug-related toxicities. Immune-related AEs (irAEs) were reported in 14 patients (93 %). The most frequent irAEs were liver (n = 12, 80 %) and skin (n = 10, 67 %) toxicities. Five deaths were reported; all were caused by progressive disease. Efficacy evaluation showed one complete response, one partial response and four patients with stable disease. Best overall response rate was 13 % (2/15), and the disease control rate was 40 % (6/15). The study was terminated early due to frequent, high-grade liver toxicities. IPI 10 mg/kg plus DTIC 850 mg/m(2) was not considered tolerable in the Japanese patient population. ClinicalTrials.gov identifier: NCT01681212.

Streptococcal throat infections and exacerbation of chronic plaque psoriasis: a prospective study.

PubMed

Gudjonsson, J E; Thorarinsson, A M; Sigurgeirsson, B; Kristinsson, K G; Valdimarsson, H

2003-09-01

Guttate psoriasis has a well-known association with streptococcal throat infections but the effects of these infections in patients with chronic psoriasis remains to be evaluated in a prospective study. To determine whether streptococcal throat infections are more common in and can cause exacerbation in patients with chronic psoriasis. Two hundred and eight patients with chronic plaque psoriasis and 116 unrelated age-matched household controls were followed for 1 year. At recruitment all patients were examined, their disease severity scored and throat swabs taken. Patients and corresponding controls were then re-examined and tested for streptococcal colonization whenever they reported sore throat or exacerbation of their psoriasis during the study period. The psoriasis patients reported sore throat significantly more often than controls (61 of 208 vs. three of 116, P < 0.0001), and beta-haemolytic streptococci of Lancefield groups A, C and G (M protein-positive streptococci) were more often cultured from the patients than the controls (19 of 208 vs. one of 116, P = 0.003). A significant exacerbation of psoriasis (P = 0.004) was observed only if streptococci were isolated and the patients were assessed 4 days or later after the onset of sore throat. No difference was observed between groups A, C or G streptococci in this respect. This study confirms anecdotal and retrospective reports that streptococcal throat infections can cause exacerbation of chronic plaque psoriasis. It is concluded that psoriasis patients should be encouraged to report sore throat to their physician and that early treatment of streptococcal throat infections might be beneficial in psoriasis. A controlled trial for assessing potential benefits of tonsillectomy in patients with severe psoriasis should also be considered.

Treating laryngopharyngeal reflux: Evaluation of an anti-reflux program with comparison to medications.

PubMed

Yang, Jin; Dehom, Salem; Sanders, Stephanie; Murry, Thomas; Krishna, Priya; Crawley, Brianna K

To determine if an anti-reflux induction program relieves laryngopharyngeal reflux (LPR) symptoms more effectively than medication and behavioral changes alone. Retrospective study. Tertiary care academic center. A database was populated with patients treated for LPR. Patients were included in the study group if they completed a two-week anti-reflux program (diet, alkaline water, medications, behavioral modifications). Patients were included in the control group if they completed anti-reflux medications and behavioral modifications only. Patients completed the voice handicap index (VHI), reflux symptom index (RSI), cough severity index (CSI), dyspnea index (DI) and eating assessment tool (EAT-10) surveys and underwent laryngoscopy for examination and reflux finding score (RFS) quantification. Of 105 study group patients, 96 (91%) reported subjective improvement in their LPR symptoms after an average 32-day first follow-up and their RSI and CSI scores improved significantly. No significant differences were found in VHI, DI, or EAT-10 scores. Fifteen study patients who had previously failed adequate high-dose medication trials reported improvement and their CSI and EAT-10 scores improved significantly. Ninety-five percent of patients with a chief complaint of cough reported improvement and their CSI scores improved significantly from 12.3 to 8.2. Among 81 controls, only 39 (48%) patients reported improvement after an average 62-day first follow-up. Their RSI scores did not significantly change. The anti-reflux program yielded rapid and substantial results for a large cohort of patients with LPR. It compared favorably with medication and behavioral modification alone. It was effective in improving cough and treating patients who had previously failed medications alone. Copyright © 2017 Elsevier Inc. All rights reserved.

Evaluation of Quality of Lower Limb Arthroplasty Observational Studies Using the Assessment of Quality in Lower Limb Arthroplasty (AQUILA) Checklist.

PubMed

Cowan, James B; Mlynarek, Ryan A; Nelissen, Rob G H H; Pijls, Bart G C W; Gagnier, Joel J

2015-09-01

This study used the assessment of quality in lower limb arthroplasty (AQUILA) checklist to assess the quality of lower limb arthroplasty observational studies. Among 132 studies the mean reporting quality score was 5.4 (SD=1.2) out of 8 possible points. Most studies adequately reported reasons for revisions (98%) and prosthesis brand and fixation (95%) in sufficient detail. Only 3% of studies adequately reported the number of patients unwilling to participate, 15% stated a clear primary research question or hypothesis, 11% reported a worst-case analysis or competing risk analysis for endpoints, and 42% reported more than 5% of patients were lost to follow-up. There is significant room for improvement in the reporting and methodology of lower limb arthroplasty observational studies. Level III. Copyright © 2015 Elsevier Inc. All rights reserved.

Intimate Partner Violence Among Patients With Dissociative Disorders.

PubMed

Webermann, Aliya R; Brand, Bethany L; Kumar, Shaina A

2017-12-01

Childhood trauma is common among survivors and perpetrators of intimate partner violence (IPV). Although symptoms of posttraumatic stress disorder (PTSD) and dissociative disorders (DDs) are predictors of IPV victimization and perpetration, few studies explore IPV among those with DDs. The present study examined IPV and symptoms as predictors among participants in the Treatment of Patients With Dissociative Disorders (TOP DD) Network study, an educational intervention for individuals with DDs and their clinicians. Both clinicians and patients reported on patients' history of physical, emotional, and sexual IPV as both victims and perpetrators. Patients self-reported dissociative, posttraumatic (PTSD), and emotion dysregulation symptoms, as well as IPV-specific dissociative symptoms. According to patients and clinicians, patients were frequently victims of IPV, most commonly emotional IPV. Dissociative symptoms predicted IPV exposure, whereas dissociative and emotion dysregulation symptoms predicted IPV-specific dissociative symptoms.

Pain Perception in Phacoemulsification with Topical Anesthesia and Evaluation of Factors Related with Pain

PubMed Central

Dadacı, Zeynep; Borazan, Mehmet; Öncel Acır, Nurşen

2016-01-01

Objectives: Evaluation of pain during and after phacoemulsification with topical anesthesia in patients with senile cataract and investigation of factors related with pain. Materials and Methods: Ninety-two adult patients scheduled for routine clear corneal phacoemulsification with topical anesthesia who had no previous cataract surgery in their fellow eyes were included in the study. Verbal pain scale and visual analog scale were used to measure pain intensity. Demographic characteristics, concomitant systemic diseases, drug consumption, need of additional anesthesia during surgery, surgical complications, duration of surgery and surgeon comfort were also evaluated for each patient. Results: Seventy-two patients (78.3%) reported pain during surgery and 68 patients (73.9%) reported pain in the period after the surgery. When the intensity of pain during the surgery was evaluated, the percentage of patients reporting mild, moderate and intense pain was 35.9%, 25.0% and 17.4%, respectively. The average verbal pain score during the surgery was 1.4±1.0 (0-3). Reported pain level was not associated with age or gender (p>0.05). Diabetic patients and patients who consumed nonsteroidal anti-inflammatory drugs in the morning before operation reported less pain during and after the surgery (p<0.05). There were no complications except posterior capsule rupture in one patient. Duration of surgery was longer in patients who reported pain during surgery (p<0.05). There was no significant difference between pain reported during surgery and surgeon comfort (p>0.05). Conclusion: Patients frequently experience pain during phacoemulsification with topical anesthesia. Although pain perception does not affect surgical success, preoperative administration of analgesics in suitable patients or giving additional anesthesia to patients reporting severe pain during surgery may increase patient comfort. PMID:28058148

The Effect of Curanderismo on Chronic Non-malignant Pain: A Case Report.

PubMed

Kennedy, Laura; Gonzales, Erin; Corbin, Lisa

2016-01-01

This case study describes the effects of the use of curanderismo, an indigenous healing modality combining techniques in massage, sound, and aromatherapy, on a patient with chronic pain. Despite being a commonly used health practice in certain populations, little is reported in the medical literature about the use of curanderismo. Case report as part of a larger randomized trial of curanderismo for chronic pain. Setting was a community-based hospital affiliated primary care clinic. An adult patient with chronic, opioid dependent back pain following an injury, and subsequent spinal fusion was treated. Intervention was the patient received 33 curanderismo treatment sessions over 10 months in addition to ongoing conventional treatment at a community-based chronic pain management clinic. Main outcomes measures were self-reported assessments of pain, functional ability, mood, insomnia, and narcotic usage. Secondary outcome measure was qualitative interview. Although there was no change in quantitative self-reported pain measures, the patient reported improved function, mood, and sleep as well as decreased narcotic usage. Curanderismo, in addition to conventional pain management, improved patient reported symptoms and functional ability, led to healthy lifestyle changes, and decreased narcotic usage. Controlled studies are needed to confirm the benefit of curanderismo as safe, non-interventional, and cost-effective adjunct for chronic pain management. Copyright © 2016 Elsevier Inc. All rights reserved.

The impact of depressive symptoms on patient–provider communication in HIV care

PubMed Central

Jonassaint, Charles R.; Haywood, Carlton; Korthuis, Philip Todd; Cooper, Lisa A.; Saha, Somnath; Sharp, Victoria; Cohn, Jonathon; Moore, Richard D.; Beach, Mary Catherine

2013-01-01

Persons with HIV who develop depression have worse medical adherence and outcomes. Poor patient–provider communication may play a role in these outcomes. This cross-sectional study evaluated the influence of patient depression on the quality of patient–provider communication. Patient–provider visits (n = 406) at four HIV care sites were audio-recorded and coded with the Roter Interaction Analysis System (RIAS). Negative binomial and linear regressions using generalized estimating equations tested the association of depressive symptoms, as measured by the Center for Epidemiology Studies Depression scale (CES-D), with RIAS measures and postvisit patient-rated quality of care and provider-reported regard for his or her patient. The patients, averaged 45 years of age (range = 20–77), were predominately male (n = 286, 68.5%), of black race (n = 250, 60%), and on antiretroviral medications (n = 334, 80%). Women had greater mean CES-D depression scores (12.0) than men (10.6; p = 0.03). There were no age, race, or education differences in depression scores. Visits with patients reporting severe depressive symptoms compared to those reporting none/mild depressive symptoms were longer and speech speed was slower. Patients with severe depressive symptoms did more emotional rapport building but less social rapport building, and their providers did more data gathering/counseling (ps < 0.05). In postvisit questionnaires, providers reported lower levels of positive regard for, and rated more negatively patients reporting more depressive symptoms (p < 0.01). In turn, patients reporting more depressive symptoms felt less respected and were less likely to report that their provider knows them as a person than none/mild depressive symptoms patients (ps < 0.05). Greater psychosocial needs of patients presenting with depressive symptoms and limited time/resources to address these needs may partially contribute to providers’ negative attitudes regarding their patients with depressive symptoms. These negative attitudes may ultimately serve to adversely impact patient–provider communication and quality of HIV care. PMID:23320529

Confidential reporting of patient safety events in primary care: results from a multilevel classification of cognitive and system factors.

PubMed

Kostopoulou, Olga; Delaney, Brendan

2007-04-01

To classify events of actual or potential harm to primary care patients using a multilevel taxonomy of cognitive and system factors. Observational study of patient safety events obtained via a confidential but not anonymous reporting system. Reports were followed up with interviews where necessary. Events were analysed for their causes and contributing factors using causal trees and were classified using the taxonomy. Five general medical practices in the West Midlands were selected to represent a range of sizes and types of patient population. All practice staff were invited to report patient safety events. Main outcome measures were frequencies of clinical types of events reported, cognitive types of error, types of detection and contributing factors; and relationship between types of error, practice size, patient consequences and detection. 78 reports were relevant to patient safety and analysable. They included 21 (27%) adverse events and 50 (64%) near misses. 16.7% (13/71) had serious patient consequences, including one death. 75.7% (59/78) had the potential for serious patient harm. Most reports referred to administrative errors (25.6%, 20/78). 60% (47/78) of the reports contained sufficient information to characterise cognition: "situation assessment and response selection" was involved in 45% (21/47) of these reports and was often linked to serious potential consequences. The most frequent contributing factor was work organisation, identified in 71 events. This included excessive task demands (47%, 37/71) and fragmentation (28%, 22/71). Even though most reported events were near misses, events with serious patient consequences were also reported. Failures in situation assessment and response selection, a cognitive activity that occurs in both clinical and administrative tasks, was related to serious potential harm.

Confidential reporting of patient safety events in primary care: results from a multilevel classification of cognitive and system factors

PubMed Central

Kostopoulou, Olga; Delaney, Brendan

2007-01-01

Objective To classify events of actual or potential harm to primary care patients using a multilevel taxonomy of cognitive and system factors. Methods Observational study of patient safety events obtained via a confidential but not anonymous reporting system. Reports were followed up with interviews where necessary. Events were analysed for their causes and contributing factors using causal trees and were classified using the taxonomy. Five general medical practices in the West Midlands were selected to represent a range of sizes and types of patient population. All practice staff were invited to report patient safety events. Main outcome measures were frequencies of clinical types of events reported, cognitive types of error, types of detection and contributing factors; and relationship between types of error, practice size, patient consequences and detection. Results 78 reports were relevant to patient safety and analysable. They included 21 (27%) adverse events and 50 (64%) near misses. 16.7% (13/71) had serious patient consequences, including one death. 75.7% (59/78) had the potential for serious patient harm. Most reports referred to administrative errors (25.6%, 20/78). 60% (47/78) of the reports contained sufficient information to characterise cognition: “situation assessment and response selection” was involved in 45% (21/47) of these reports and was often linked to serious potential consequences. The most frequent contributing factor was work organisation, identified in 71 events. This included excessive task demands (47%, 37/71) and fragmentation (28%, 22/71). Conclusions Even though most reported events were near misses, events with serious patient consequences were also reported. Failures in situation assessment and response selection, a cognitive activity that occurs in both clinical and administrative tasks, was related to serious potential harm. PMID:17403753

Protocol-developing meta-ethnography reporting guidelines (eMERGe).

PubMed

France, E F; Ring, N; Noyes, J; Maxwell, M; Jepson, R; Duncan, E; Turley, R; Jones, D; Uny, I

2015-11-25

Designing and implementing high-quality health care services and interventions requires robustly synthesised evidence. Syntheses of qualitative research studies can provide evidence of patients' experiences of health conditions; intervention feasibility, appropriateness and acceptability to patients; and advance understanding of health care issues. The unique, interpretive, theory-based meta-ethnography synthesis approach is suited to conveying patients' views and developing theory to inform service design and delivery. However, meta-ethnography reporting is often poor quality, which discourages trust in, and use of, meta-ethnography findings. Users of evidence syntheses require reports that clearly articulate analytical processes and findings. Tailored research reporting guidelines can raise reporting standards but none exists for meta-ethnography. This study aims to create an evidence-based meta-ethnography reporting guideline articulating the methodological standards and depth of reporting required to improve reporting quality. The mixed-methods design of this National Institute of Health Research-funded study (http://www.stir.ac.uk/emerge/) follows good practice in research reporting guideline development comprising: (1) a methodological systematic review (PROSPERO registration: CRD42015024709) to identify recommendations and guidance in conducting/reporting meta-ethnography; (2) a review and audit of published meta-ethnographies to identify good practice principles and develop standards in conduct/reporting; (3) an online workshop and Delphi studies to agree guideline content with 45 international qualitative synthesis experts and 45 other stakeholders including patients; (4) development and wide dissemination of the guideline and its accompanying detailed explanatory document, a report template for National Institute of Health Research commissioned meta-ethnographies, and training materials on guideline use. Meta-ethnography, devised in the field of education, is now used widely in other disciplines. Methodological advances relevant to meta-ethnography conduct exist. The extent of discipline-specific adaptations of meta-ethnography and the fit of any adaptions with the underpinning philosophy of meta-ethnography require investigation. Well-reported meta-ethnography findings could inform clinical decision-making. A bespoke meta-ethnography reporting guideline is needed to improve reporting quality, but to be effective potential users must know it exists, trust it and use it. Therefore, a rigorous study has been designed to develop and promote a guideline. By raising reporting quality, the guideline will maximise the likelihood that high-quality meta-ethnographies will contribute robust evidence to improve health care and patient outcomes.

The Patient Reported Outcomes, Burdens and Experiences (PROBE) Project: development and evaluation of a questionnaire assessing patient reported outcomes in people with haemophilia.

PubMed

Skinner, M W; Chai-Adisaksopha, C; Curtis, R; Frick, N; Nichol, M; Noone, D; O'Mahony, B; Page, D; Stonebraker, J S; Iorio, A

2018-01-01

The interest of health care agencies, private payers and policy makers for patient-reported outcomes (PRO) is continuously increasing. There is a substantial need to improve capacity to collect and interpret relevant PRO data to support implementation of patient-centered research and optimal care in haemophilia. The Patient Reported Outcomes, Burdens and Experiences (PROBE) Project aims to develop a patient-led research network, to develop a standardized questionnaire to gather patient-reported outcomes and to perform a feasibility study of implementing the PROBE questionnaire. A pilot questionnaire was developed using focus group methodology. Content and face validity were assessed by a pool of persons living with haemophilia (PWH) and content experts through interactive workshops. The PROBE questionnaire was translated with the forward-backward approach. PROBE recruited national haemophilia patient non-governmental organizations (NGOs) to administer the questionnaire to people with and without haemophilia. PROBE measured the time to complete the questionnaire and gathered feedback on its content and clarity; staff time and cost required to implement the questionnaire were also collected. The PROBE questionnaire is comprised of four major sections (demographic data, general health problems, haemophilia-related health problems and health-related quality of life using EQ-5D-5L and EQ-VAS). Seventeen NGOs participated in the pilot study of the PROBE Project, recruiting 656 participants. Of these, 71% completed the questionnaire within 15 min, and all participants completed within 30 min. The median total staff and volunteer time required for the NGOs to carry out the study within their country was 9 h (range 2 to 40 h). NGO costs ranged from $22.00 to $543.00 USD per country, with printing and postage being the most commonly reported expenditures. The PROBE questionnaire assesses patient-important reported outcomes in PWH and control participants, with a demonstrated short completion time. PROBE proved the feasibility to engage diverse patient communities in the structured generation of real-world outcome research at all stages. Trial registration: NCT02439710.

Decreased physical activity attributable to higher body mass index influences fibromyalgia symptoms.

PubMed

Vincent, Ann; Clauw, Daniel; Oh, Terry H; Whipple, Mary O; Toussaint, Loren L

2014-09-01

Although previous studies report associations between increased body mass index (BMI) and fibromyalgia symptoms, there is uncertainty as to whether this relationship is driven by physical factors, psychological factors, or both. To assess these relationships in a clinical sample of patients with fibromyalgia. Cross-sectional study. Tertiary care facility. A total of 686 patients from an existing national fibromyalgia registry. Patients completed a demographic form and self-report questionnaires including the Fibromyalgia Impact Questionnaire-Revised (FIQ-R), the Medical Outcomes Study Short Form-36 (SF-36), the Brief Pain Inventory (BPI), and the 30-item Profile of Mood States (30-item POMS). FIQ-R overall impact subscale. BMI was significantly correlated with fibromyalgia impact (P < .001). The relationship between BMI and fibromyalgia impact was almost fully accounted for by physical factors and not by psychological factors. Despite patient report that pain hinders physical activity, clinicians who encounter patients with fibromyalgia, particularly patients with increased BMI, should be cognizant of the need to invest time and resources to counsel patients on physical factors (ie, physical activity) that could improve the patients' symptom experience. Copyright © 2014 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

A randomized, double-blind, placebo-controlled, cross-over study to assess the efficacy of tadalafil (Cialis[reg]) in the treatment of erectile dysfunction following three-dimensional conformal external-beam radiotherapy for prostatic carcinoma

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

Incrocci, Luca; Slagter, Cleo; Slob, A. Koos

2006-10-01

Purpose: Erectile dysfunction after three-dimensional conformal external-beam radiotherapy (3DCRT) for prostatic carcinoma is reported in as many as 64% of those patients. The purpose of this study was to determine the efficacy of the oral drug tadalafil (Cialis (registered) ) in patients with erectile dysfunction after radiotherapy for prostatic carcinoma. Methods and Materials: Patients (N = 358) who completed radiotherapy at least 12 months before the study were approached by mail. All patients had been treated by 3DCRT; 60 patients were included and entered a double-blind, placebo-controlled, cross-over study lasting 12 weeks. They received 20 mg of tadalafil or placebomore » for 6 weeks. Drug or placebo was taken on demand at patient's discretion, with no restrictions regarding the consumption of alcohol or food, at least once a week and no more than once daily. At 6 weeks patients crossed over to the alternative treatment. Data were collected using the Sexual Encounter Profile (SEP) and the International Index of Erectile Function (IIEF) questionnaires. Side effects were also recorded. Results: Mean age at study entry was 69 years. All patients completed the study. For almost all questions of the IIEF questionnaire there was a significant increase in mean scores from baseline with tadalafil, but not with placebo. Sixty-seven percent of the patients reported an improvement of erectile function with tadalafil (placebo: 20%), and 48% reported successful intercourse with tadalafil (placebo: 9%) (p < 0.0001). Side effects were mild or moderate. Conclusions: Tadalafil is an effective treatment for erectile dysfunction after 3DCRT for prostatic carcinoma with successful intercourse reported in almost 50% of the patients, and it is well tolerated.« less

Tailored prolapse surgery for the treatment of hemorrhoids with a new dedicated device: TST Starr plus.

PubMed

Naldini, G; Fabiani, B; Menconi, C; Giani, I; Toniolo, G; Martellucci, J

2015-12-01

The aim of the study was to assess the results of the stapled transanal procedure in the treatment of hemorrhoidal prolapse in terms of postoperative complications and recurrence rate using a new dedicated device, TST Starr plus. Patients affected by III-IV degree hemorrhoidal prolapsed that underwent stapled transanal resection with the TST Starr plus were included in the present study. Results of the procedure with perioperative complications, postoperative complications, and recurrence rate were reported. From November 2012 to October 2014, 52 patients (19 females) were enrolled in the study. The main symptoms were prolapse (100 %) and bleeding (28.8 %). Transanal rectal resection was performed with parachute technique in 24 patients (46.2 %) and purse string technique in 23 patients (53.8 %). A mild hematoma at the suture line occurred in one patient (1.9 %). Postoperative bleeding was reported in three patients (5.7 %), in one of which, reoperation was necessary (1.9 %). Tenesmus occurred in one patient (1.9 %), and it was resolved with medical therapy. Urgency was reported in nine patients (17.1 %) at 7 days after surgery. Of these, three patients (5.7 %) complained urgency at the median follow-up of 14.5 months. Reoperation was performed in one patient (1.9 %) for chronic anal pain for rigid suture fixed on the deep plans. Occasional bleeding was reported in four patients (7.7 %). No recurrence of prolapse was reported at a median of 14.5 months after surgery, even if one patient (1.9 %) had a partial recurrent prolapse of a downstaged single pile. TST Starr plus seems to be safe and effective for a tailored transanal stapled surgery for the treatment of III-IV degree hemorrhoidal prolapse. The new conformation and innovative technology of the stapler seems to reduce some postoperative complications and recurrence rate.

Near-death experience in survivors of cardiac arrest: a prospective study in the Netherlands.

PubMed

van Lommel, P; van Wees, R; Meyers, V; Elfferich, I

2001-12-15

Some people report a near-death experience (NDE) after a life-threatening crisis. We aimed to establish the cause of this experience and assess factors that affected its frequency, depth, and content. In a prospective study, we included 344 consecutive cardiac patients who were successfully resuscitated after cardiac arrest in ten Dutch hospitals. We compared demographic, medical, pharmacological, and psychological data between patients who reported NDE and patients who did not (controls) after resuscitation. In a longitudinal study of life changes after NDE, we compared the groups 2 and 8 years later. 62 patients (18%) reported NDE, of whom 41 (12%) described a core experience. Occurrence of the experience was not associated with duration of cardiac arrest or unconsciousness, medication, or fear of death before cardiac arrest. Frequency of NDE was affected by how we defined NDE, the prospective nature of the research in older cardiac patients, age, surviving cardiac arrest in first myocardial infarction, more than one cardiopulmonary resuscitation (CPR) during stay in hospital, previous NDE, and memory problems after prolonged CPR. Depth of the experience was affected by sex, surviving CPR outside hospital, and fear before cardiac arrest. Significantly more patients who had an NDE, especially a deep experience, died within 30 days of CPR (p<0.0001). The process of transformation after NDE took several years, and differed from those of patients who survived cardiac arrest without NDE. We do not know why so few cardiac patients report NDE after CPR, although age plays a part. With a purely physiological explanation such as cerebral anoxia for the experience, most patients who have been clinically dead should report one.

A prospective study of changes in anxiety, depression, and problems in living during chemotherapy treatments: effects of age and gender.

PubMed

Bergerot, Cristiane Decat; Mitchell, Hannah-Rose; Ashing, Kimlin Tam; Kim, Youngmee

2017-06-01

Monitoring distress assessment in cancer patients during the treatment phase is a component of good quality care practice. Yet, there is a dearth of prospective studies examining distress. In an attempt to begin filling this gap and inform clinical practice, we conducted a prospective, longitudinal study examining changes in distress (anxiety, depression, and problems in living) by age and gender and the roles of age and gender in predicting distress. Newly diagnosed Brazilian cancer patients (N = 548) were assessed at three time points during chemotherapy. Age and gender were identified on the first day of chemotherapy (T1); anxiety, depression, and problems in living were self-reported at T1, the planned midway point (T2), and the last day of chemotherapy (T3). At T1, 37 and 17% of patients reported clinically significant levels of anxiety and depression, respectively. At T3, the prevalence was reduced to 4.6% for anxiety and 5.1% for depression (p < .001). Patients 40-55 years, across all time points, reported greater anxiety and practical problems than patients >70 years (p < .03). Female patients reported greater emotional, physical, and family problems than their male counterparts (p < .04). For most patients, elevated levels of distress noted in the beginning of treatment subsided by the time of treatment completion. However, middle-aged and female patients continued to report heightened distress. Evidence-based psychosocial intervention offered to at risk patients during early phases of the treatment may provide distress relief and improve outcomes over the illness trajectory while preventing psychosocial and physical morbidity due to untreated chronic distress.

Patient-Reported Treatment Satisfaction with Rivaroxaban for Stroke Prevention in Atrial Fibrillation. A French Observational Study, the SAFARI Study.

PubMed

Hanon, Olivier; Chaussade, Edouard; Gueranger, Pierre; Gruson, Elise; Bonan, Sabrina; Gay, Alain

2016-01-01

For antithrombotic treatments, Patient Reported Outcomes (PRO) and patient satisfaction with treatment are essential data for physicians because of the strong relationship between patient satisfaction and adherence to treatment. The impact of rivaroxaban on patient satisfaction and quality of life was not sufficiently documented in phase III studies. There is a need for further data in this field especially in real life conditions. The SAFARI study is composed of patients with non-valvular atrial fibrillation (AF), previously treated with vitamin K antagonist (VKA) and switched to rivaroxaban. Patient satisfaction with anticoagulant therapy was measured by the Anti-Clot Treatment Scale (ACTS), a validated 15-item patient-reported scale including a 12-item ACTS Burdens scale and a 3-item ACTS Benefits scale. Satisfaction of medication was compared between baseline and 1, 3 and 6 months. Study population was composed of 405 patients. Mean age was 74.8 (standard deviation = 9.0) years and 63.0% were male. Mean CHA2DS2-VASc score was 3.4 (1.5) and mean HAS-BLED score was 2.9 (1.0). After 3 months of treatment with rivaroxaban, patient satisfaction improved compared with VKA: mean ACTS burdens scores significantly increased by 8.3 (8.9) points (p<0.0001) and ACTS benefits scale by 0.4 (2.9) (p<0.001). Compared with baseline, the improvement in ACTS burdens and benefits became apparent at 1 month (46.5 vs. 53.6 p<0.001 and 10.4 vs. 10.7, p<0.05 respectively) and persisted at 6 months (46.5 vs. 54.76 p<0.001 and 10.4 vs. 10.8 p = 0.02 respectively). Rivaroxaban persistence was 88.7% at 6 months. SAFARI data support a good risk-benefit balance for rivaroxaban, with a good safety profile and encourage PRO design studies. The switch from VKA to rivaroxaban improved patient satisfaction at 1, 3 and 6 months after rivaroxaban initiation among patients with AF, particularly in reducing patient-reported anticoagulation burden.

Assessment of intraoperative pain during Mohs micrographic surgery (MMS): An opportunity for improved patient care.

PubMed

Connolly, Karen L; Nehal, Kishwer S; Dusza, Stephen W; Rossi, Anthony M; Lee, Erica H

2016-09-01

Intraoperative pain during Mohs micrographic surgery (MMS) has not been characterized. However, many patients report postoperative pain on the day of MMS. We sought to determine if patients experience pain during their MMS visit. In phase I of this study, patients were asked to report intraoperative pain level using the verbal numerical rating scale (0-10) at discharge. In phase II, pain levels were assessed before each Mohs layer and at discharge, to determine whether pain was experienced throughout the day. Pain was reported at some point during the MMS day for 32.8% of patients (n = 98). The mean pain number reported was 3.7 (range 1-8) out of 10. Pain was more commonly reported by patients who spent a longer time in the office, had 3 or more Mohs layers, and had a flap or graft repair. Patients most frequently reported pain with surgical sites of the periorbital area and nose. Time between Mohs layers was not measured. There was nonstandardized use of intraoperative local anesthesia volume and oral pain medications. Some patients experience pain during MMS. However, the majority of patients report a low level of pain. Additional preventative measures could be considered in patients at higher risk. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Exercise habits and factors associated with exercise in systemic sclerosis: a Scleroderma Patient-centered Intervention Network (SPIN) cohort study.

PubMed

Azar, Marleine; Rice, Danielle B; Kwakkenbos, Linda; Carrier, Marie-Eve; Shrier, Ian; Bartlett, Susan J; Hudson, Marie; Mouthon, Luc; Poiraudeau, Serge; van den Ende, Cornelia H M; Johnson, Sindhu R; Rodriguez Reyna, Tatiana Sofia; Schouffoer, Anne A; Welling, Joep; Thombs, Brett D

2018-08-01

Exercise is associated with improved health in many medical conditions. Little is known about the exercise habits of people with systemic sclerosis (SSc, or scleroderma). This study assessed the proportion of individuals with SSc who exercise and associations of demographic and disease variables with exercise. Additionally, the weekly amount of time spent exercising and the types of exercise performed were assessed among patients exercising. The sample consisted of adult participants with SSc enrolled in the Scleroderma Patient-centered Intervention Network (SPIN) Cohort who completed baseline questionnaires from March 2014 through August 2015. Baseline questionnaires included questions on exercise habits, physician-reported medical characteristics, self-report demographic characteristics, the Health Assessment Questionnaire-Disability Index, Patient Health Questionnaire-9, and Patient-Reported Outcomes Measurement Information System-29. Of 752 patients, 389 (51.7%) reported presently engaging in exercise, and these patients exercised on average 4.7 h [standard deviation (SD) = 2.8] per week. Among patients who reported exercising, walking was most commonly reported (n = 295, 75.8%). In bivariate analyses, present exercise was associated with more education, lower body mass index, some (versus no) alcohol consumption, non-smoking, limited/sine disease subtype, absence of skin thickening, lower disability, higher physical function, lower symptoms of anxiety and depression, less fatigue, lower sleep disturbance, higher ability to participate in social roles and activities, and less pain. Approximately half of SSc patients reported that they are currently exercising with walking being the most common form of exercise. Understanding exercise patterns and factors associated with exercise will help better inform intervention programs to support exercise for patients with SSc. Implications for rehabilitation Systemic sclerosis is a rare autoimmune rheumatic disease associated with great morbidity and highly diverse presentation. Approximately half of people with both limited and diffuse systemic sclerosis report exercising. Most exercisers walk, but patients engage in a wide variety of exercise-related activities. Individually designed exercise programs are most likely to support and encourage exercise in patients with diverse disease manifestations.

Long-Term Outcomes of Patients with Tracheoesophageal Fistula/Esophageal Atresia: Survey Results from Tracheoesophageal Fistula/Esophageal Atresia Online Communities.

PubMed

Acher, Charles Wynn; Ostlie, Daniel J; Leys, Charles M; Struckmeyer, Shannon; Parker, Matthew; Nichol, Peter F

2016-12-01

Introduction  Outcome studies of tracheoesophageal fistula (TEF) and/or esophageal atresia (EA) are limited to retrospective chart reviews. This study surveyed TEF/EA patients/parents engaged in social media communities to determine long-term outcomes. Materials and Methods  A 50-point survey was designed to study presentation, interventions, and ongoing symptoms after repair in patients with TEF/EA. It was validated using a test population and made available on TEF/EA online communities. Results  In this study, 445 subjects completed the survey during a 2-month period. Mean age of patients when surveyed was 8.7 years (0-61 years) and 56% were male. Eighty-nine percent of surveys were completed by the parent of the patient. Sixty-two percent of patients underwent repair in the first 7 days of life. Standard open repair was most common (56%), followed by primary esophageal replacement (13%) and thoracoscopic repair (13%). Out of 405, 106 (26%) patients had postoperative leak. Postoperative leak was least likely in primary esophageal replacement (18%) and standard open repair (19%). Leak occurred in 32% of patients who had thoracoscopic repair; 31% (128/413) reported long-gap atresia, which was significantly associated with increased risk of postoperative leak (54/128, 42%) when compared with standard short-gap atresia (odds ratio, 3.5; p  = 0.001). Out of 409, 221 (54%) patients reported dysphagia after repair, with only 77/221 (34.8%) reporting resolution by age 5. Out of 381, 290 (76%) patients reported symptoms of gastroesophageal reflux disease (GERD). There was no difference in dysphagia rates or GERD symptoms based on type of initial repair. Antireflux surgery was required in 63/290, 22% of patients with GERD (15% of all patients) and 27% of these patients who had surgery required more than one procedure antireflux procedure. The most common was Nissen fundoplication (73%), followed by partial wrap (14%). Reflux recurred in 32% of patients after antireflux surgery. Conclusion  TEF/EA patients have long-term dysphagia and GERD that may be under reported. Retrospective studies of outcomes after TEF/EA repair may underestimate long-term esophageal dysmotility, dysphagia, GERD, and strictures that occur regardless of the type of repair and adversely affect quality of life. Fifteen percent of all TEF/EA patients surveyed required an antireflux procedure during childhood, and more than one-quarter of those required repeat surgery. These data demonstrate the need for long-term follow-up as pediatric patients transition to adult care. Georg Thieme Verlag KG Stuttgart · New York.

Prescription refill, patient self-report and physician report in assessing adherence to oral endocrine therapy in early breast cancer patients: a retrospective cohort study in Catalonia, Spain

PubMed Central

Font, R; Espinas, J A; Gil-Gil, M; Barnadas, A; Ojeda, B; Tusquets, I; Segui, M A; Margelí, M; Arcusa, A; Prat, A; Garcia, M; Borras, J M

2012-01-01

Aims: To compare different methods in order to assess adherence and persistence with oral endocrine therapy in women diagnosed with breast cancer (BC) in Catalonia. Materials and methods: This study covered all women newly diagnosed with stage I, II or IIIa BC and positive hormone receptors at six hospitals in Catalonia (Spain) in 2004. Adherence was assessed on the basis of physician report and patient self-report using a telephone questionnaire. Persistence was measured by refill prescriptions. We used the Kappa index to compare adherence measures and logistic regression to evaluate adherence-related risk factors. Results: The study covered a total of 692 women. Adherence ranged from 92% (self-report) to 94.7% (physician report), depending on the measure used; persistence was 74.7% at 5 years of follow-up. Low concordance between measures was observed (Kappa range: 0.018–0.267). Patients aged 50–74 years showed higher adherence than those aged <50 years. Adherence was also associated with: adjuvant chemotherapy and sequential hormonal therapy. Conclusions: Concordance between the different measures was remarkably low, indicating the need for further research. Adherence is an issue in the management of BC patients taking oral drugs, and should be assessed in clinical practice. PMID:22955858

Delayed wound healing after tooth extraction and self-reported kyphosis in Japanese men and women

PubMed Central

Taguchi, Akira; Kamimura, Mikio; Nakamura, Yukio; Sugino, Noriyuki; Ichinose, Akira; Maezumi, Hisayoshi; Fukuzawa, Takashi; Ashizawa, Ryouhei; Takahara, Kenji; Gushiken, Susumu; Mukaiyama, Keijiro; Ikegami, Shota; Uchiyama, Shigeharu; Kato, Hiroyuki

2016-01-01

It is unclear whether osteoporosis itself is a main risk factor for delayed wound healing after tooth extraction in humans. In this study, we evaluated the association between experience of delayed wound healing after last tooth extraction and self-reported kyphosis, with the possibility of having vertebral fractures, in Japanese patients. Among the 1,504 patients who responded to the structured questionnaire survey, 518 patients (134 men and 384 women) aged 55–97 years finally participated in this study. Patients who self-reported mild-moderate kyphosis were more likely to have problematic delayed wound healing after last tooth extraction than those who reported severe kyphosis (odds ratio [OR] 4.98; 95% confidence interval [CI], 1.86–13.38 and OR 2.30; 95% CI, 0.52–10.22, respectively) (p for trend = 0.005). Japanese patients with vertebral fractures may have a higher risk of having problematic delayed wound healing after tooth extraction. PMID:27848958

Delayed wound healing after tooth extraction and self-reported kyphosis in Japanese men and women.

PubMed

Taguchi, Akira; Kamimura, Mikio; Nakamura, Yukio; Sugino, Noriyuki; Ichinose, Akira; Maezumi, Hisayoshi; Fukuzawa, Takashi; Ashizawa, Ryouhei; Takahara, Kenji; Gushiken, Susumu; Mukaiyama, Keijiro; Ikegami, Shota; Uchiyama, Shigeharu; Kato, Hiroyuki

2016-11-16

It is unclear whether osteoporosis itself is a main risk factor for delayed wound healing after tooth extraction in humans. In this study, we evaluated the association between experience of delayed wound healing after last tooth extraction and self-reported kyphosis, with the possibility of having vertebral fractures, in Japanese patients. Among the 1,504 patients who responded to the structured questionnaire survey, 518 patients (134 men and 384 women) aged 55-97 years finally participated in this study. Patients who self-reported mild-moderate kyphosis were more likely to have problematic delayed wound healing after last tooth extraction than those who reported severe kyphosis (odds ratio [OR] 4.98; 95% confidence interval [CI], 1.86-13.38 and OR 2.30; 95% CI, 0.52-10.22, respectively) (p for trend = 0.005). Japanese patients with vertebral fractures may have a higher risk of having problematic delayed wound healing after tooth extraction.

The contribution of direct patient reported ADRs to drug safety signals in the Netherlands from 2010 to 2015.

PubMed

van Hunsel, Florence; de Waal, Susan; Härmark, Linda

2017-08-01

The purpose of this study was to investigate the contribution of patient reports to signals sent by the Netherlands Pharmacovigilance Centre Lareb to the Dutch Medicines Evaluation Board and to determine if there are certain types of signals where patient report add a distinct contribution. All signals from 2010 until 2015 were included. First, we investigated how many patient reports were present in the signals and the characteristics of these reports compared to the health care professional and marketing authorization holders' reports. In addition to source, the analysis included ATC code of the drug, MedDRA® system organ class and preferred term for the adverse drug reaction (ADR), seriousness of the ADR, and 7 other factors like reports on over-the-counter medication, and how often an ADR listed in the important medical event terms list was present. Secondly, we determined the proportion of reports submitted by the individual groups to signals, in a cross-sectional manner. A total of 150 signals were included, including 1691 ADR reports. Our results show that 26.3% of all ADR reports in Dutch drug safety signals were reported by patients, and 30.5% of the patient reports in the signals contained one or more terms listed as important medical events. The proportion of reports by patients which were included the signals was 2% and 3.9% for health care professional reports and 0.2% for marketing authorization holders reports. Patients had an important contribution to signals overall, but especially for ADRs related to generic drug substitution and psychiatric ADRs. Copyright © 2017 John Wiley & Sons, Ltd.

Patient initiated clinics for patients with chronic or recurrent conditions managed in secondary care: a systematic review of patient reported outcomes and patient and clinician satisfaction

PubMed Central

2013-01-01

Background The cost to the NHS of missed or inappropriate hospital appointments is considerable. Alternative methods of appointment scheduling might be more flexible to patients’ needs without jeopardising health and service quality. The objective was to systematically review evidence of patient initiated clinics in secondary care on patient reported outcomes among patients with chronic/recurrent conditions. Methods Seven databases were searched from inception to June 2013. Hand searching of included studies references was also conducted. Studies comparing the effects of patient initiated clinics with traditional consultant led clinics in secondary care for patients with long term chronic or recurrent diseases on health related quality of life and/or patient satisfaction were included. Data was extracted by one reviewer and checked by a second. Results were synthesised narratively. Results Seven studies were included in the review, these covered a total of 1,655 participants across three conditions: breast cancer, inflammatory bowel disease and rheumatoid arthritis. Quality of reporting was variable. Results showed no significant differences between the intervention and control groups for psychological and health related quality of life outcomes indicating no evidence of harm. Some patients reported significantly more satisfaction using patient-initiated clinics than usual care (p < 0.001). Conclusions The results show potential for patient initiated clinics to result in greater patient and clinician satisfaction. The patient-consultant relationship appeared to play an important part in patient satisfaction and should be considered an important area of future research as should the presence or absence of a guidebook to aid self-management. Patient initiated clinics fit the models of care suggested by policy makers and so further research into long term outcomes for patients and service use in this area of practice is both relevant and timely. PMID:24289832

Relationship Between Mood Disturbance and Sleep Quality in Oncology Outpatients at the Initiation of Radiation Therapy

PubMed Central

Van Onselen, Christina; Dunn, Laura B.; Lee, Kathryn; Dodd, Marylin; Koetters, Theresa; West, Claudia; Paul, Steven M.; Aouizerat, Bradley E.; Wara, William; Swift, Patrick; Miaskowski, Christine

2010-01-01

Purpose of the research The purpose of this study was to describe the occurrence of significant mood disturbance and evaluate for differences in sleep quality among four mood groups (i.e., neither anxiety nor depression, only anxiety, only depression, anxiety and depression) prior to the initiation of radiation therapy (RT). Methods and sample Patients (n=179) with breast, prostate, lung, and brain cancer were evaluated prior to the initiation of RT using the Pittsburgh Sleep Quality Index (PSQI), the Center for Epidemiological Studies Depression Scale, and the Spielberger State Anxiety Inventory. Differences in sleep disturbance among the four mood groups were evaluated using analyses of variance. Key results While 38% of the patients reported some type of mood disturbance, 57% of the patients reported sleep disturbance. Patients with clinically significant levels of anxiety and depression reported the highest levels of sleep disturbance. Conclusions Overall, oncology patients with mood disturbances reported more sleep disturbance than those without mood disturbance. Findings suggest that oncology patients need to be assessed for mood and sleep disturbances. PMID:20080444

Medium-term and long-term outcomes of interventions for primary psoas tendinopathy.

PubMed

Garala, Kanai; Prasad, Vishnu; Jeyapalan, Kanagaratnam; Power, Richard A

2014-05-01

To assess medium- and long-term outcomes of psoas tendinopathy to psoas tenotomy and image-guided steroid injections. This is a 14-year retrospective case-control study to identify the efficacy of psoas tenotomy and image-guided steroid injections. This study was undertaken in a secondary care setting. Patients with confirmed psoas tendinopathy were followed up by postal questionnaire, which included a nonarthritic hip score (NAHS) and a study patient satisfaction questionnaire. Patients underwent image-guided steroid injections. Depending on the analgesic or symptomatic relief, some patients proceeded to psoas tenotomy. Response to steroid injection. Pain relief and symptomatic relief after the surgery. Twenty-three patients were reviewed with a 70% follow-up over a time of 49 months for surgery (range, 13-144 months) and 77 months for injection (range, 14-160 months). Eight patients had a lasting response to injection and required no further intervention, and 15 patients proceeded to psoas tenotomy using a medial Ludloff approach. The average NAHS scores after the surgery and injection were 66.15 and 76.08, respectively. Ten patients reported pain relief after their tenotomy, and 5 patients reported no change in pain. All 8 patients, who only underwent injection, reported lasting pain relief. Local steroid injections can provide long-term relief for patients presenting with psoas tendinopathy. For those patients with only temporary relief from injection, psoas tenotomy can provide good long-term pain relief.

[A descriptive analysis of naratriptan use among migraineurs in ambulatory medicine].

PubMed

Brudon-Mollard, F; Druais, P-L; Giacomino, A; Hinault, P; Lanteri-Minet, M; Zaïm, M; Chemali-Hudry, J; El Hasnaoui, A

2003-05-01

The objective of this study was to provide an epidemiological description of naratriptan use in ambulatory medicine. 1695 patients were recruited by 384 primary care physicians and 111 neurologists, and followed for 12 weeks. Physicians had to document the migraine history, and to report symptoms and health care in a structured case report form. Patients were to document each episode of migraine (EM) in a diary. At baseline, 45 p.cent of the patients reported their migraine treatment as unsatisfactory. Ninety-eight percent of included patients were migraineurs according to criteria of the International Headache Society (IHS), including migrainous disorders. Ninety-two percent of naratriptan prescriptions were established in the second intention in patients with migraine, according to the IHS classification, including migrainous disorders. A total of 79 p.cent of patients had complied with the good practices for all EMs. More appropriate health education strategies should target the small group of patients who over-use naratriptan, and patients with aura. However, this study shows that naratriptan tends to be correctly prescribed by physicians, and used by patients with acute migraine.

Understanding “revolving door” patients in general practice: a qualitative study

PubMed Central

2014-01-01

Background ‘Revolving door’ patients in general practice are repeatedly removed from general practitioners’ (GP) lists. This paper reports a qualitative portion of the first mixed methods study of these marginalised patients. Methods We conducted qualitative semi-structured interviews with six practitioner services staff and six GPs in Scotland, utilizing Charmazian grounded theory to characterise ‘revolving door’ patients and their impact from professionals’ perspectives. Results ‘Revolving door’ patients were reported as having three necessary characteristics; they had unreasonable expectations, exhibited inappropriate behaviours and had unmet health needs. A range of boundary breaches were reported too when ‘revolving door’ patients interacted with NHS staff. Conclusions We utilise the ‘sensitising concepts’ of legitimacy by drawing on literature about ‘good and bad’ patients and ‘dirty work designations.’ We relate these to the core work of general practice and explore the role that medical and moral schemas have in how health service professionals understand and work with ‘revolving door’ patients. We suggest this may have wider relevance for the problem doctor patient relationship literature. PMID:24524363

Supporting Asian patients with metastatic breast cancer during ixabepilone therapy.

PubMed

Bourdeanu, Laura; Wong, Siu-Fun

2010-05-01

Ixabepilone is currently FDA-approved in metastatic breast cancer, and most patients in the registrational trials were Caucasian. Studies in Asian populations receiving other cytotoxic agents have revealed differential pharmacokinetics and clinical outcomes. As such, clinicians should understand the possible contributions of Asian ethnicity and culture to the clinical profile of ixabepilone. Studies in Asian patients receiving other chemotherapeutics reported altered toxicity profiles for myelosuppression, neurotoxicity and gastrointestinal symptoms. Encouragingly, the limited clinical data in Asian patients receiving ixabepilone suggest that efficacy and toxicity in these women resemble those reported in the ixabepilone registrational trials. The reader will better understand how Asian genetics and culture may influence treatment outcomes and patient attitudes toward therapy and interaction with caregivers. Management of ixabepilone-related adverse events is also discussed with an emphasis on special considerations for Asian patients. Awareness of possible altered drug response in Asian patients will aid clinicians in monitoring for toxicity, recognizing the need for dose modification and educating patients. Sensitivity to cultural aspects that are unique to Asians may improve adherence, reporting of adverse events and trust among Asian patients receiving ixabepilone.

Patient-Provider Communication and Health Outcomes Among Individuals With Atherosclerotic Cardiovascular Disease in the United States: Medical Expenditure Panel Survey 2010 to 2013.

PubMed

Okunrintemi, Victor; Spatz, Erica S; Di Capua, Paul; Salami, Joseph A; Valero-Elizondo, Javier; Warraich, Haider; Virani, Salim S; Blaha, Michael J; Blankstein, Ron; Butt, Adeel A; Borden, William B; Dharmarajan, Kumar; Ting, Henry; Krumholz, Harlan M; Nasir, Khurram

2017-04-01

Consumer-reported patient-provider communication (PPC) assessed by Consumer Assessment of Health Plans Survey in ambulatory settings is incorporated as a complementary value metric for patient-centered care of chronic conditions in pay-for-performance programs. In this study, we examine the relationship of PPC with select indicators of patient-centered care in a nationally representative US adult population with established atherosclerotic cardiovascular disease. The study population consisted of a nationally representative sample of 6810 individuals (aged ≥18 years), representing 18.3 million adults with established atherosclerotic cardiovascular disease (self-reported or International Classification of Diseases, Ninth Edition diagnosis) reporting a usual source of care in the 2010 to 2013 pooled Medical Expenditure Panel Survey cohort. Participants responded to questions from Consumer Assessment of Health Plans Survey that assessed PPC, and we developed a weighted PPC composite score using their responses, categorized as 1 (poor), 2 (average), and 3 (optimal). Outcomes of interest were (1) patient-reported outcomes: 12-item Short Form physical/mental health status, (2) quality of care measures: statin and ASA use, (3) healthcare resource utilization: emergency room visits and hospital stays, and (4) total annual and out-of-pocket healthcare expenditures. Atherosclerotic cardiovascular disease patients reporting poor versus optimal were over 2-fold more likely to report poor outcomes; 52% and 26% more likely to report that they are not on statin and aspirin, respectively, had a significantly greater utilization of health resources (odds ratio≥2 emergency room visit, 1.41 [95% confidence interval, 1.09-1.81]; odds ratio≥2 hospitalization, 1.36 [95% confidence interval, 1.04-1.79]), as well as an estimated $1243 ($127-$2359) higher annual healthcare expenditure. This study reveals a strong relationship between PPC and patient-reported outcomes, utilization of evidence-based therapies, healthcare resource utilization, and expenditures among those with established atherosclerotic cardiovascular disease. © 2017 American Heart Association, Inc.

Schizophrenic Patients' Perceptions of Stress, Expressed Emotion, and Sensitivity To Criticism

PubMed Central

Cutting, Linda P.; Aakre, Jennifer M.; Docherty, Nancy M.

2006-01-01

This study was designed to get an “insider's view” of expressed emotion (EE) from the perspective of schizophrenic patients. Thirty-two patient and “influential other” pairs participated in the study. Patients' perceptions of EE attitudes in influential others were examined to determine whether they corresponded with actual EE ratings. Patients also rated how “stressed” they felt when interacting with their influential others, and patients' general sensitivity to criticism (STC) was assessed. As predicted, patients' perceptions of critical attitudes were related to actual EE ratings of criticism, although patients' perceptions of emotional overinvolvement (EOI) were not related to EOI ratings. Patients reported feeling more stressed when interacting with high-EE influential others, supporting an “EE as stressor” hypothesis. Finally, patients' STC influenced the level of stress they reported. PMID:16731686

Real-world persistence with fingolimod for the treatment of multiple sclerosis: A systematic review and meta-analysis.

PubMed

Kantor, Daniel; Johnson, Kristen; Vieira, Maria Cecilia; Signorovitch, James; Li, Nanxin; Gao, Wei; Koo, Valerie; Duchesneau, Emilie; Herrera, Vivian

2018-05-15

To systematically review reports of fingolimod persistence in the treatment of relapsing-remitting multiple sclerosis (RRMS) across data sources and practice settings, and to develop a consensus estimate of the 1-year real-world persistence rate. A systematic literature review was conducted (MEDLINE, EMBASE, and abstracts from selected conferences [2013-2015]) to identify observational studies reporting 1-year fingolimod persistence among adult patients with RRMS (sample size ≥50). A random-effects meta-analysis was performed to estimate a synthesized 1-year persistence rate and to assess heterogeneity across studies. Of 527 publications identified, 25 real-world studies reporting 1-year fingolimod persistence rates were included. The studies included patients from different data sources (e.g., administrative claims, electronic medical records, or registries), used different definitions of persistence (e.g., based on prescriptions refills, patient report, or prescription orders), and spanned multiple geographic regions. Reported 1-year persistence rates ranged from 72%-100%, and exhibited statistical evidence of heterogeneity (I 2  = 93% of the variability due to heterogeneity across studies). The consensus estimate of the 1-year persistence rate was 82% (95% confidence interval: 79%-85%). Across heterogeneous study designs and patient populations found in real-world studies, the consensus 1-year fingolimod persistence rate exceeded 80%, consistent with persistence rates identified in the recently-completed trial, PREFERMS. Copyright © 2018. Published by Elsevier B.V.

Living-donor vs deceased-donor liver transplantation for patients with hepatocellular carcinoma.

PubMed

Akamatsu, Nobuhisa; Sugawara, Yasuhiko; Kokudo, Norihiro

2014-09-27

With the increasing prevalence of living-donor liver transplantation (LDLT) for patients with hepatocellular carcinoma (HCC), some authors have reported a potential increase in the HCC recurrence rates among LDLT recipients compared to deceased-donor liver transplantation (DDLT) recipients. The aim of this review is to encompass current opinions and clinical reports regarding differences in the outcome, especially the recurrence of HCC, between LDLT and DDLT. While some studies report impaired recurrence - free survival and increased recurrence rates among LDLT recipients, others, including large database studies, report comparable recurrence - free survival and recurrence rates between LDLT and DDLT. Studies supporting the increased recurrence in LDLT have linked graft regeneration to tumor progression, but we found no association between graft regeneration/initial graft volume and tumor recurrence among our 125 consecutive LDLTs for HCC cases. In the absence of a prospective study regarding the use of LDLT vs DDLT for HCC patients, there is no evidence to support the higher HCC recurrence after LDLT than DDLT, and LDLT remains a reasonable treatment option for HCC patients with cirrhosis.

Influence of Human Factor Issues on Patient-Centered mHealth Apps' Impact; Where Do We Stand?

PubMed

Wildenbos, G A; Peute, L W; Jaspers, M W M

2016-01-01

This paper discusses the preliminary results of a literature review on studies published in 2014-2015 concerning patient-centered mHealth applications' (apps) impact. Abstracts were included when they described a mHealth app targeted at patients and reported on the effects of this app on patient care. From a total of 559 potentially relevant articles, 17 papers were finally included. Nine studies reported a positive impact of the patient-centered mHealth app on patient care; 4 of these studies were randomized controlled trials. Measured impacts in the 17 studies focused on improving patients' physical activity, self-efficacy and medication adherence. Human factors issues potentially mediating these effects were discussed in all studies. Transitions in the interaction between healthcare providers and their patients were most often discussed as influencing the impact of the mHealth app. More research is needed, focussing on human issues mediating the effect of patient-centered mHealth apps to precipitate knowledge on the effectiveness of mHealth. This research should preferably be guided by socio-technical models.

Kindler syndrome in native Americans from Panama: report of 26 cases.

PubMed

Penagos, Homero; Jaen, Marta; Sancho, Mario T; Saborio, Manuel R; Fallas, Victor G; Siegel, Dawn H; Frieden, Ilona J

2004-08-01

To investigate the clinical, genetic, and laboratory features of 26 patients with Kindler syndrome. Case series of patients recruited when they were seen at outpatient consultations in the Department of Dermatology at the Changuinola Hospital in Bocas del Toro, Panama, between May 1986 and December 1990. Clinical history, physical examination, and laboratory studies were done at a community hospital in Panama. Twelve of the patients had further studies performed at a children's hospital in Costa Rica. A total of 26 patients were entered into the study. They were members of the Ngöbe-Buglé tribe and resided in isolated villages in rural Panama. The major findings were skin fragility with blistering (100%), poikiloderma (96%), photosensitivity (92%), severe cutaneous atrophy (89%), hyperkeratosis of the palms and soles (81%), congenital acral blisters (81%), severe periodontal disease (81%), and phimosis (80% of male subjects). In 1 large family with 10 patients, inheritance of Kindler syndrome followed that of an autosomal recessive disease. Karyotypes in 3 patients and 1 unaffected father were normal. Findings from ultrastructural studies showed replication of lamina densa in 10 patients. To our knowledge, this study represents the largest series to date of patients with Kindler syndrome. The clinical features confirm previously reported cases, and segregation analysis confirms its autosomal recessive inheritance. We also report severe phimosis as a complication, which has not been previously described in this syndrome.

Clearance of hepatitis C viral RNA in cirrhotic patients with antiviral therapy.

PubMed

Ono, S K; da Silva, L C; Carrilho, F J; da Fonseca, L E; Mendes, L C; Madruga, C L; Farias, A de Q; Laudanna, A A

1996-01-01

Interferon is indicated in chronic infection by hepatitis C virus (HCV), however, cirrhosis has been reported as a bad response factor to the therapy. Fifteen cirrhotic patients with HCV, undergoing treatment with recombinant interferon-alpha, ribavirin and/or ursodeoxycholic acid were studied. They were followed-up and evaluated with dosages of alanine aminotransferase and HCV RNA investigation by PCR technique. Of the 15 cirrhotic patients, seven were negative for HCV RNA after antiviral treatment, however ALT was normal in only three of them. Of the eight patients who were not negative, two had normal ALT. Biochemical-virological discrepancy in the follow-up of the patients after antiviral treatment observed in this study has also been reported by other authors. These reports show that the criteria for response to the treatment is to be established.

Patient and Healthcare Provider Barriers to Hypertension Awareness, Treatment and Follow Up: A Systematic Review and Meta-Analysis of Qualitative and Quantitative Studies

PubMed Central

Khatib, Rasha; Schwalm, Jon-David; Yusuf, Salim; Haynes, R. Brian; McKee, Martin; Khan, Maheer; Nieuwlaat, Robby

2014-01-01

Background Although the importance of detecting, treating, and controlling hypertension has been recognized for decades, the majority of patients with hypertension remain uncontrolled. The path from evidence to practice contains many potential barriers, but their role has not been reviewed systematically. This review aimed to synthesize and identify important barriers to hypertension control as reported by patients and healthcare providers. Methods Electronic databases MEDLINE, EMBASE and Global Health were searched systematically up to February 2013. Two reviewers independently selected eligible studies. Two reviewers categorized barriers based on a theoretical framework of behavior change. The theoretical framework suggests that a change in behavior requires a strong commitment to change [intention], the necessary skills and abilities to adopt the behavior [capability], and an absence of health system and support constraints. Findings Twenty-five qualitative studies and 44 quantitative studies met the inclusion criteria. In qualitative studies, health system barriers were most commonly discussed in studies of patients and health care providers. Quantitative studies identified disagreement with clinical recommendations as the most common barrier among health care providers. Quantitative studies of patients yielded different results: lack of knowledge was the most common barrier to hypertension awareness. Stress, anxiety and depression were most commonly reported as barriers that hindered or delayed adoption of a healthier lifestyle. In terms of hypertension treatment adherence, patients mostly reported forgetting to take their medication. Finally, priority setting barriers were most commonly reported by patients in terms of following up with their health care providers. Conclusions This review identified a wide range of barriers facing patients and health care providers pursuing hypertension control, indicating the need for targeted multi-faceted interventions. More methodologically rigorous studies that encompass the range of barriers and that include low- and middle-income countries are required in order to inform policies to improve hypertension control. PMID:24454721

Effects of patient-reported non-severe hypoglycemia on healthcare resource use, work-time loss, and wellbeing in insulin-treated patients with diabetes in seven European countries.

PubMed

Geelhoed-Duijvestijn, Petronella H; Pedersen-Bjergaard, Ulrik; Weitgasser, Raimund; Lahtela, Jorma; Jensen, Marie Markert; Östenson, Claes-Göran

2013-12-01

Hypoglycemia is a frequent side effect induced by insulin treatment of type 1 (T1DM) and type 2 diabetes (T2DM). Limited data exist on the associated healthcare resource use and patient impact of hypoglycemia, particularly at a country-specific level. This study investigated the effects of self-reported non-severe hypoglycemic events (NSHE) on use of healthcare resources and patient wellbeing. Patients with T1DM or insulin-treated T2DM diabetes from seven European countries were invited to complete four weekly questionnaires. Data were collected on patient demographics, NSHE occurrence in the last 7 days, hypoglycemia-related resource use, and patient impact. NSHE were defined as events with hypoglycemia symptoms, with or without blood glucose measurement, or low blood glucose measurement without symptoms, which the patient could manage without third-party assistance. Three thousand, nine hundred and fifty-nine respondents completed at least one wave of the survey, with 57% completing all four questionnaires; 3827 respondents were used for data analyses. Overall, 2.3% and 8.9% of NSHE in patients with T1DM and T2DM, respectively, resulted in healthcare professional contact. Across countries, there was a mean increase in blood glucose test use of 3.0 tests in the week following a NSHE. Among respondents who were employed (48%), loss of work-time after the last hypoglycemic event was reported for 9.7% of NSHE. Overall, 10.2% (daytime) and 8.0% (nocturnal) NSHE led to work-time loss, with a mean loss of 84.3 (daytime) and 169.6 (nocturnal) minutes among patients reporting work-time loss. Additionally, patients reported feeling tired, irritable, and having negative feelings following hypoglycemia. Direct comparisons between studies must be interpreted with caution because of different definitions of hypoglycemia severity, duration of the studies, and methods of data collection. NSHE were associated with use of extra healthcare resources and work-time loss in all countries studied, suggesting that NSHE have considerable impact on patients/society.

Does rewording MRI reports improve patient understanding and emotional response to a clinical report?

PubMed

Bossen, Jeroen K J; Hageman, Michiel G J S; King, John D; Ring, David C

2013-11-01

Diagnostic MRI reports can be distressing for patients with limited health literacy. Humans tend to prepare for the worst particularly when we are in pain, and words like "tear" can make us feel damaged and in need of repair. Research on words used in provider-patient interactions have shown an affect on response to treatment and coping strategies, but the literature on this remains relatively sparse. The aim of this observational cross-sectional study is to determine whether rewording of MRI reports in understandable, more dispassionate language will result in better patient ratings of emotional response, satisfaction, usefulness, and understanding. Furthermore, we wanted to find out which type of report patients would choose to receive. One hundred patients visiting an orthopaedic hand and upper extremity outpatient office for reasons unrelated to the presented MRI report were enrolled. Four MRI reports, concerning upper extremity conditions, were reworded to an eighth-grade reading level and with the use of neutral descriptive words and the most optimistic interpretations based on current best evidence. After reading each report, emotional response was measured using the Self Assessment Manikin (SAM). Subjects also completed questions about satisfaction, usefulness, and understanding of the report. According to the results of the SAM questionnaire, the reworded MRI reports resulted in significantly higher pleasure and dominance scores and lower arousal scores. The mean satisfaction, usefulness, and understanding scores of the reworded report were significantly higher compared with the original reports. Seventy percent of the patients preferred the reworded reports over the original reports. Emotional response, satisfaction, usefulness, and understanding were all superior in MRI reports reworded for lower reading level and optimal emotional content and optimism. Given that patients increasingly have access to their medical records and diagnostic reports, attention to health literacy and psychologic aspects of the report may help optimize health and patient satisfaction.

Six-month, open-label study of hydrocodone extended release formulated with abuse-deterrence technology: Safety, maintenance of analgesia, and abuse potential.

PubMed

Hale, Martin E; Ma, Yuju; Malamut, Richard

2016-01-01

To evaluate long-term safety, maintenance of analgesia, and aberrant drug-related behaviors of hydrocodone extended release (ER) formulated with CIMA® Abuse-Deterrence Technology. Phase 3, multicenter, open-label extension. Fifty-six US centers. Adults with chronic low back pain completing a 12-week placebocontrolled study of abuse-deterrent hydrocodone ER were eligible. One hundred eighty-two patients enrolled and received ≥1 dose of study drug, 170 entered openlabel treatment, and 136 completed the study. Patients receiving hydrocodone ER in the 12-week, placebo-controlled study continued their previous dose unless adjustment was needed; those previously receiving placebo (n=78) underwent dose titration/adjustment to an analgesic dose (15-90 mg every 12 hours). Patients received 22 weeks of open-label treatment. adverse events (AEs). Maintenance of analgesia: worst pain intensity (WPI) and average pain intensity (API) at each study visit. Aberrant drug behavior: study drug loss and diversion. AEs were reported for 65/182 (36 percent) patients during dose titration/ adjustment and 88/170 (52 percent) during open-label treatment. No treatmentrelated serious AEs were reported. There were no clinically meaningful trends in other safety assessments, including physical examinations and pure tone audiometry. One patient receiving hydrocodone ER 30 mg twice daily experienced a severe AE of neurosensory deafness that was considered treatment related. Mean WPI and API remained steady throughout open-label treatment. Six (3 percent) patients reported medication loss, and 5 (3 percent) reported diversion. Abuse-deterrent hydrocodone ER was generally well tolerated in patients with chronic low back pain, maintained efficacy, and was associated with low rates of loss and diversion.

An app for patient education and self-audit within an enhanced recovery program for bowel surgery: a pilot study assessing validity and usability.

PubMed

Pecorelli, Nicolò; Fiore, Julio F; Kaneva, Pepa; Somasundram, Abarna; Charlebois, Patrick; Liberman, A Sender; Stein, Barry L; Carli, Franco; Feldman, Liane S

2018-05-01

While patient engagement and clinical audit are key components of successful enhanced recovery programs (ERPs), they require substantial resource allocation. The objective of this study was to assess the validity and usability of a novel mobile device application for education and self-reporting of adherence for patients undergoing bowel surgery within an established ERP. Prospectively recruited patients undergoing bowel surgery within an ERP used a novel app specifically designed to provide daily recovery milestones and record adherence to 15 different ERP processes and six patient-reported outcomes (PROs). Validity was measured by the agreement index (Cohen's kappa coefficient for categorical, and interclass correlation coefficient (ICC) for continuous variables) between patient-reported data through the app and data recorded by a clinical auditor. Acceptability and usability of the app were measured by the System Usability Scale (SUS). Forty-five patients participated in the study (mean age 61, 64% male). Overall, patients completed 159 of 179 (89%) of the available questionnaires through the app. Median time to complete a questionnaire was 2 min 49 s (i.q.r. 2'32″-4'36″). Substantial (kappa > 0.6) or almost perfect agreement (kappa > 0.8) and strong correlation (ICC > 0.7) between data collected through the app and by the clinical auditor was found for 14 ERP processes and four PROs. Patient-reported usability was high; mean SUS score was 87 (95% CI 83-91). Only 6 (13%) patients needed technical support to use the app. Forty (89%) patients found the app was helpful to achieve their daily goals, and 34 (76%) thought it increased their motivation to recover after surgery. This novel application provides a tool to record patient adherence to care processes and PROs, with high agreement with traditional clinical audit, high usability, and patient satisfaction. Future studies should investigate the use of mobile device apps as strategies to increase adherence to perioperative interventions.

Patient- and clinician-reported satisfaction with pharmacological stress agents for single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI).

PubMed

Hudgens, Stacie; Breeze, Janis; Spalding, James

2013-01-01

The objective of this study was to compare clinician and patient measures of satisfaction with two pharmacological stress agents (PSA), regadenoson and dipyridamole, used in Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI). This observational study included patients who had undergone SPECT MPI with regadenoson or dipyridamole, as well as the clinician/clinical technologist who performed the test. Mean scores for individual item and domain scores of the main outcome measures were computed as well as the effect sizes (ES) of the mean difference in scores between treatment groups. Statistical significance of the mean item and domain score differences were assessed via Mann-Whitney tests. Two self-report questionnaires which had beeb previously developed and validated: Patient Satisfaction/Preference Questionnaire (PSPQ) and Clinician Satisfaction/Preference Questionnaire (CSPQ). A total of 87 patients (68 received regadenoson, 19 received dipyridamole) and nine clinicians/clinical technologists took part in the study. Patients had a mean age of 66.8 ± 12.2 years, and 56.3% were male. Compared to dipyridamole, use of regadenoson was associated with greater clinician satisfaction on all items and domains of the CSPQ (p < 0.001 for all comparisons). Among patients, regadenoson was associated with less bother and greater satisfaction than dipyridamole for all items on the PSPQ. These patients reported less stinging at the injection site (ES = -0.66) and less nervousness during injection (ES = -0.60). The PSPQ found that regadenoson patients were more satisfied with their PSA than dipyridamole patients in all areas. This study utilized a relatively small sample size of dipyridamole patients and lacked an adenosine group. A broader sampling of professionals would also help demonstrate generalizability. Both patients and clinicians reported higher satisfaction with regadenoson compared to dipyridamole for SPECT-MPI. Clinicians were particularly satisfied with the preparation and administration aspects of the drug, while patients rated it highly on convenience and reduced incidence of side-effects.

Retention, dosing, tolerability and patient reported seizure outcome of Zonisamide as only add-on treatment under real-life conditions in adult patients with partial onset seizures: Results of the observational study ZOOM.

PubMed

Hamer, Hajo; Baulac, Michel; McMurray, Rob; Kockelmann, Edgar

2016-01-01

Zonisamide is licensed for adjunctive therapy for partial-onset seizures with or without secondary generalisation in patients 6 years and older and as monotherapy for the treatment of partial seizures in adult patients with newly diagnosed epilepsy, and shows a favourable pharmacokinetic profile with low interaction potential with other drugs. The aim of the present study was to gather real-life data on retention and modalities of zonisamide use when administered as only add-on treatment to a current AED monotherapy in adult patients with partial-onset seizures. This multicenter observational study was performed in 4 European countries and comprised three visits: baseline, and after 3 and 6 months. Data on patients' retention, reported efficacy, tolerability and safety, and quality of life was collected. Of 100 included patients, 93 could be evaluated. After 6 months, the retention rate of zonisamide add-on therapy was 82.8%. At this time, a reduction of seizure frequency of at least 50% was observed in 79.7% of patients, with 43.6% reporting seizure freedom over the last 3 months of the study period. Adverse events were reported by 19.4% of patients, with fatigue, agitation, dizziness, and headache being most frequent. Approximately 25% of patients were older than 60 years, many of whom suffered from late-onset epilepsy. Compared to younger patients, these patients showed considerable differences with regard to their antiepileptic drug regimen at baseline, and slightly higher responder and retention rates at 6 months. Despite limitations due to the non-interventional open-label design and the low sample size, the results show that zonisamide as only add-on therapy is well retained, indicating effectiveness in the majority of patients under real-life conditions. Copyright © 2015. Published by Elsevier Ltd.

Comparison of assessment of personality disorder by patients and informants.

PubMed

Modestin, J; Puhan, A

2000-01-01

The present study evaluated the pathology of personality disorder in a group of 8 nonpatient volunteers and 32 psychiatric in- and outpatients, most of them suffering from substance abuse disorder. The patient self-reports were compared with the reports by 2 informants for each proband. All probands and informants completed the Structured Interview for DSM-III-R Axis II Personality Questionnaire. Patient self-reports and informant reports yielded the same number of diagnoses. The diagnostic agreement between the three sets of data was generally poor; however, the concordance was slightly better between both groups of informants than between patients and informants: Median kappa were 0.13 for patients versus parents, 0.14 for patients versus brothers/sisters and 0.29 for parents versus brothers/sisters. Patient and informant evaluations represent two different assessment approaches of the personality, and a complete agreement is not to be expected. Copyright 2000 S. Karger AG, Basel.

Hemorrhagic fever with acute renal failure: a report from Kosova.

PubMed

Zylfiu, Bejtush Ibrahim; Elezi, Ymer; Bajraktari, Gani; Rudhani, Ibrahim; Abazi, Murat; Kryeziu, Emrush

2008-03-01

Acute renal failure (ARF) is a well-known complication of hemorrhagic fever (HF). We studied patients with HF and ARF who were treated in our department for two years between March 2005 and the end of December 2006. The age of the patients ranged from 17 to 71 years. The incidence of complications in the study patients was acceptable and similar to that reported in the literature of Balkan region. Our study shows that the efficacy of the overall results in the treatment of these patients in our center is comparable to the published data in the country from the Balkan region.

Relationship between patient-reported and objective measurements of hand function in patients with rheumatoid arthritis.

PubMed

Günay, S M; Tuna, Z; Oskay, D

2016-12-31

Rheumatoid arthritis (RA) often results in impairments in upper extremities, especially in the small joints of hand. Involvement of hand brings limitations in activities of daily living. However, it is commonly observed that patient-reported functional status of hand does not always corresponds to their actual physical performance in the clinical setting. The aim of this pilot study is to investigate the relationship between patient self-reported and objectively measured hand functions in patients with RA. Twenty-six patients (51±13 years) with RA diagnosis participated in the study. Hand grip and pinch (lateral, bipod, tripod) strengths were measured and Jebsen Hand Function Test (JHFT) was performed for objective functional performance. Duruöz Hand Index and Beck Depression Inventory - Turkish version were completed by patients. Grip and all three-pinch strength results significantly correlated with Duruöz Hand Index scores (p<0.05). JHFT results except the sentence writing also correlated with the Duruöz scores (p<0.05). Our results showed that self-reported outcome scales might be used for determining functional level of hand in patients with RA in rheumatology practice. Objective quantitative functional tests are the best methods in evaluating functional level of hand, but require valid and reliable equipment with accurate calibration. Therefore, in case of unavailability of objective assessment tools, patient-reported scales may also reflect the real status of hand functions.

Mental distress and health-related quality of life among type 1 and type 2 diabetes patients using self-monitoring of blood glucose: A cross-sectional questionnaire study in Japan.

PubMed

Tanaka, Nagaaki; Yabe, Daisuke; Murotani, Kenta; Ueno, Shinji; Kuwata, Hitoshi; Hamamoto, Yoshiyuki; Kurose, Takeshi; Takahashi, Nobuo; Akashi, Tomoyuki; Matsuoka, Takashi; Osonoi, Takeshi; Minami, Masae; Shimono, Dai; Seino, Yutaka

2018-03-01

The present multicenter, cross-sectional survey was initiated to evaluate self-monitoring of blood glucose (SMBG)-associated mental distress among patients with diabetes. The survey was carried out in patients with type 1 diabetes and type 2 diabetes using SMBG recruited from 42 medical institutions. Profiles of Mood States 2 and diabetes therapy-related quality of life questionnaires were used to evaluate mood status and health-related quality of life. Two original questionnaires were also developed to evaluate SMBG 'importance,' 'painfulness' and 'confidence' among patients, and to evaluate physician attitudes to SMBG use. Questionnaires from 517 type 1 diabetes and 1,648 type 2 diabetes patients showed that 46.0% of type 1 diabetes and 37.5% of type 2 diabetes patients reported 'painfulness,' and that these patients reporting 'painfulness' showed significantly higher Profiles of Mood States 2 scores, lower diabetes therapy-related quality of life scores and higher glycated hemoglobin compared with those not reporting 'painfulness,' whereas the number of their daily SMBG tests were comparable. Patients reporting 'painfulness' also reported that SMBG use was significantly less important. Whether or not patients recognized the importance of SMBG use was well correlated with the frequency of physicians checking patient diaries. Type 1 diabetes and type 2 diabetes patients reporting 'painfulness' in SMBG use had more mental distress, lower health-related quality of life and higher glycated hemoglobin regardless of their number of daily SMBG tests. The importance of SMBG use was recognized less by patients experiencing pain, and the importance of SMBG use was recognized more in medical institutions in which physicians regularly checked SMBG diaries to provide meaningful feedback to patients in clinical settings. © 2018 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

A systematic review of outcomes after revision amputation for treatment of traumatic finger amputation

PubMed Central

Yuan, Frank; McGlinn, Evan P.; Giladi, Aviram M.; Chung, Kevin C.

2015-01-01

Background Revision amputations are often the treatment for traumatic finger amputation injuries. However, patient outcomes are inadequately reported, and their impact poorly understood. We performed a systematic review to evaluate outcomes of revision amputations and amputation wound coverage techniques. Methods We searched all available English literature in PubMed and EMBASE for articles reporting outcomes of non-replantation treatments for traumatic finger amputation injuries, including revision amputation, local digital flaps, skin grafting, and conservative treatment. Data extracted were study characteristics, patient demographic data, sensory and functional outcomes, patient-reported outcomes (PROs), and complications. Results 1659 articles were screened, yielding 43 studies for review. Mean static 2-point discrimination (2-PD) was 5.0 ± 1.5 mm (n=23 studies) overall. Mean static 2-PD was 6.1 ± 2.4 mm after local flap procedures and 3.8 ± 0.4 mm after revision amputation. Mean total active motion (TAM) was 93 ± 8% of normal (n=6 studies) overall. Mean TAM was 90 ± 9% of normal after local flap procedures and 95% of normal after revision amputation. 77% of patients report cold intolerance after revision amputation. 91% of patients (217/238) report “satisfactory” or “good/excellent” ratings regardless of treatment. Conclusion Revision amputation and conservative treatments result in better static 2-PD outcomes compared to local flaps. All techniques preserve TAM, although arc of motion is slightly better with revision amputation. Revision amputation procedures are frequently associated with cold intolerance. Patients report “satisfactory,” “good,” or “excellent” ratings in appearance and quality of life with all non-replantation techniques. Level of Evidence III PMID:26111316

Patients' identification and reporting of unsafe events at six hospitals in Japan.

PubMed

Hasegawa, Tomonori; Fujita, Shigeru; Seto, Kanako; Kitazawa, Takefumi; Matsumoto, Kunichika

2011-11-01

Hospitals and other health care organizations have increasingly recognized the need to engage patients as participants in patient safety. A study was conducted to compare patients' and health care staff's identification and reporting of such events. A questionnaire was administered at six hospitals in Japan to outpatients and inpatients from November 2004 through February 2007. Patients were asked to respond to questions about experiences of possibly unsafe events. Patients experiencing such events were then asked about the events and whether they had reported their experience to health care staff. A specialist panel classified reported events as "uneasy-dissatisfying" or "unsafe." The response rates of outpatients and inpatients were 85.4% (1,506/1,764) and 54.3% (1,738/3,198), respectively. Among the respondents (> or = 20 years of age), 125 (8.7%) of the outpatients and 185 (10.9%) of the inpatients experienced uneasy-dissatisfying or unsafe events; 35 (2.4%) of the outpatients and 67 (4.0%) of the inpatients experienced unsafe events, the percent increasing with hospital stay. Only 38 (30.4%) of the outpatients and 62 (33.5%) of the inpatients reported the unsafe events to health care staff Only 17.1% of unsafe events reported by inpatients were identified by the in-house reporting systems of adverse events and near misses. For the uneasy-dissatisfying or unsafe events that patients did not think necessary to report, the patients often felt they were self-evident or easily identifiable by health care staff, had difficulty evaluating the event, did not expect their report to bring any improvement, or even felt that reporting it would create some disadvantage in their medical treatment. Patient reporting programs and in-house reporting systems, among other detection methods, should be regarded as complementary sources of information.

Patient-Centred Innovations for Persons with Multimorbidity: funded evaluation protocol.

PubMed

Stewart, Moira; Fortin, Martin

2017-05-09

The high prevalence of multimorbidity necessitates rethinking of the health care system. The overarching goal of the Patient-Centred Innovations for Persons with Multimorbidity program is to build on existing structures and find and evaluate patient-centred innovations relevant to multimorbidity. We describe the protocol for a proposed multijurisdictional (Quebec and Ontario) concurrent triangulation mixed-methods study. In both provinces, a qualitative descriptive study will be used to explore innovations in patient-centred multimorbidity care. Two randomized controlled trials, 1 in either province, will evaluate the innovations in a wait-list-controlled design using patient-reported outcomes. An additional control group, matched on age, sex, enrolment/index date (± 3 mo) and propensity score, will be created with the use of health administrative data. Patients will be 18-80 years of age and will have 3 or more chronic conditions. The innovations will have elements of relevance to multimorbidity care, patient-centred partnerships and integration of care. The primary outcome measures will be 2 patient-reported outcomes: patient education and self-efficacy. Secondary outcomes will include patient-reported health status, quality of life, psychological distress and health behaviours, and costs of care. This protocol describes a mixed-method study in 2 jurisdictions. The studies will answer the questions of what innovations work and how they work for patients, health care professionals and policy-makers. Trial registration: ClinicalTrials.gov, no NCT02789800 (Quebec Trial), NCT02742597 (Ontario Trial). Copyright 2017, Joule Inc. or its licensors.

Musical ear syndrome in adult cochlear implant patients.

PubMed

Low, W-K; Tham, C A; D'Souza, V-D; Teng, S-W

2013-09-01

Except for a single case report, musical ear syndrome in cochlear implantees has not been studied. We aimed to study the prevalence and nature of musical ear syndrome among adult cochlear implant patients, as well as the effect on their emotional well-being. STUDY DESIGN, PATIENTS AND INTERVENTION: A cross-sectional survey of patients aged 18 years and above who had received cochlear implants for profound hearing loss between 1997 and 2010. Of the 82 patients studied, 18 (22 per cent) were found to have experienced musical ear syndrome. Seven and 11 patients had musical ear syndrome prior to and after cochlear implantation, respectively. The character of musical ear syndrome symptoms was described as instrumental music (n = 2), singing (6) or both (10). Fourteen patients reported an adverse emotional effect, with three expressing ‘intolerance’. In this study, 22 per cent of cochlear implantees experienced musical ear syndrome. These symptoms affected patients’ emotional state, but most coped well. Musical ear syndrome can occur prior to and after cochlear implantation.

Evaluating test-retest reliability in patient-reported outcome measures for older people: A systematic review.

PubMed

Park, Myung Sook; Kang, Kyung Ja; Jang, Sun Joo; Lee, Joo Yun; Chang, Sun Ju

2018-03-01

This study aimed to evaluate the components of test-retest reliability including time interval, sample size, and statistical methods used in patient-reported outcome measures in older people and to provide suggestions on the methodology for calculating test-retest reliability for patient-reported outcomes in older people. This was a systematic literature review. MEDLINE, Embase, CINAHL, and PsycINFO were searched from January 1, 2000 to August 10, 2017 by an information specialist. This systematic review was guided by both the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist and the guideline for systematic review published by the National Evidence-based Healthcare Collaborating Agency in Korea. The methodological quality was assessed by the Consensus-based Standards for the selection of health Measurement Instruments checklist box B. Ninety-five out of 12,641 studies were selected for the analysis. The median time interval for test-retest reliability was 14days, and the ratio of sample size for test-retest reliability to the number of items in each measure ranged from 1:1 to 1:4. The most frequently used statistical methods for continuous scores was intraclass correlation coefficients (ICCs). Among the 63 studies that used ICCs, 21 studies presented models for ICC calculations and 30 studies reported 95% confidence intervals of the ICCs. Additional analyses using 17 studies that reported a strong ICC (>0.09) showed that the mean time interval was 12.88days and the mean ratio of the number of items to sample size was 1:5.37. When researchers plan to assess the test-retest reliability of patient-reported outcome measures for older people, they need to consider an adequate time interval of approximately 13days and the sample size of about 5 times the number of items. Particularly, statistical methods should not only be selected based on the types of scores of the patient-reported outcome measures, but should also be described clearly in the studies that report the results of test-retest reliability. Copyright © 2017 Elsevier Ltd. All rights reserved.

Meaninglessness in terminally ill cancer patients: a validation study and nurse education intervention trial.

PubMed

Morita, Tatsuya; Murata, Hisayuki; Hirai, Kei; Tamura, Keiko; Kataoka, Jun; Ohnishi, Hideki; Akizuki, Nobuya; Kurihara, Yukie; Akechi, Tatsuo; Uchitomi, Yosuke

2007-08-01

Recent empirical studies revealed that fostering patients' perception of meaning in their life is an essential task for palliative care clinicians. However, few studies have reported the effects of training programs for nurses specifically aimed at improving skills to relieve the meaninglessness of terminally ill cancer patients, and we have had no specific measurement instruments. The primary aims of this study were 1) to validate measurement tools to quantify nurses' self-reported practice and attitudes toward caring for terminally ill cancer patients feeling meaninglessness and 2) to explore the effects of the five-hour educational workshop focusing on meaninglessness on nurses' self-reported practice, attitudes toward caring for such patients, confidence, burnout, death anxiety, and meaning of life. A quasi-experimental pre-post questionnaire survey was performed on 147 nurses. The questionnaire was distributed before the intervention workshop and one and six months after. The workshop consisted of lecture, role-play, and the exercise of assessment and care planning based on two vignette verbatim records. First, using the first questionnaire sample and an additional sample of 20 nurses for the test-retest examination, we validated a six-item Self-Reported Practice scale, and an eight-item Attitudes Toward Caring for Patients Feeling Meaninglessness scale with three subscales (Willingness to Help, Positive Appraisal, and Helplessness). The nurses also completed a scale to assess confidence in caring for terminally ill patients with meaninglessness, the Maslach Burnout Inventory, the Death Attitude Inventory, the Frommelt Attitudes Toward Care of the Dying scale, the Self-Reported Practice Score in General Communication, and the three pain-related items from the Palliative Care Quiz for Nursing. For the Self-Reported Practice scale and the subscales of the Attitudes Toward Caring for Patients Feeling Meaninglessness scale, the Cronbach's alpha coefficients were 0.63-0.91, and the intra-class correlations were 0.89-0.94. The Self-Reported Practice scale significantly, but moderately, correlated with the Self-Reported Practice Score in General Communication (P=0.41). The Willingness to Help and Helplessness subscales significantly but weakly correlated with the Frommelt scale (P=-0.27, 0.21). Both scales did not correlate or minimally correlated with the Palliative Care Quiz for Nursing (P<0.20). The construct validity was confirmed using factor analysis. At the follow-up, of 147 nurses who participated in this workshop, 91 (62%) and 80 (54%) nurses responded. Self-reported practice and confidence significantly improved, whereas helplessness, emotional exhaustion, and death anxiety significantly decreased. The percentages of nurses who evaluated this program as "useful" or "very useful" were 79% (to understand the conceptual framework in caring for terminally ill patients with meaninglessness), 73% (to help in self-disclosing nurses' personal beliefs, values, and life goals), and 80% (to help in learning how to provide care for patients with meaninglessness). The Self-Reported Practice scale and the Attitudes Toward Caring for Patients Feeling Meaninglessness scale are reliable and valid tools to specifically quantify nurses' self-reported practice and attitudes toward caring for terminally ill cancer patients feeling meaninglessness of life. The five-hour workshop appeared to have a modest but significant beneficial effect on nurse-reported practice, attitudes, and confidence in providing care for terminally ill cancer patients feeling meaninglessness. Further educational intervention trials with control groups are promising.

Transaxillary breast augmentation: two breast cancer patients with successful sentinel lymph node diagnosis.

PubMed

Mottura, A Aldo; Del Castillo, René

2007-01-01

In recent years, some surgeons have been warned of possible problems with sentinel lymph node diagnosis (SLND) for patients who have undergone transaxillary breast augmentation (TBA), although no scientific studies support this warning. The authors report two additional cases of breast cancer in which the SLND was successfully performed for patients with previous TBA. The surgical anatomy of the axilla, the groups of lymph nodes, and a personal way of performing TBA are described. Five other reports concerning the same issue are thoroughly discussed. Four of these are clinical in vivo reports, and one is a cadaver study. The four in vivo studies and what we are reporting now clearly demonstrate that what was said regarding possible problems in the SLND after TBA was not founded on clinical research and contradicts these five clinical findings.

Formal thought disorder, neuropsychology and insight in schizophrenia.

PubMed

Barrera, Alvaro; McKenna, Peter J; Berrios, German E

2009-01-01

Information provided by patients with schizophrenia and their respective carers is used to study the descriptive psychopathology and neuropsychology of formal thought disorder (FTD). Relatively intellectually preserved schizophrenia patients (n = 31) exhibiting from no to severe positive FTD completed a self-report scale of FTD, a scale of insight as well as several tests of executive and semantic function. The patients' carers completed another scale of FTD to assess the patients' speech. FTD as self-reported by patients was significantly associated with the synonyms test performance and severity of the reality distortion dimension. FTD as assessed by a clinician and by the patients' carers was significantly associated with executive test performance and performance in a test of associative semantics. Overall insight was significantly associated with severity of the reality distortion dimension and graded naming test performance, but was not associated with self-reported FTD or severity of FTD as assessed by the clinician or carers. The self-reported experience of FTD has different clinical and neuropsychological correlates from those of FTD as assessed by clinicians and carers. The assessment of FTD by patients and carers used along with the clinician's assessment may further the study of this group of symptoms. 2009 S. Karger AG, Basel.

Communicating Patient Status: Comparison of Teaching Strategies in Prelicensure Nursing Education.

PubMed

Lanz, Amelia S; Wood, Felecia G

Research indicates that nurses lack adequate preparation for reporting patient status. This study compared 2 instructional methods focused on patient status reporting in the clinical setting using a randomized posttest-only comparison group design. Reporting performance using a standardized communication framework and student perceptions of satisfaction and confidence with learning were measured in a simulated event that followed the instruction. Between the instructional methods, there was no statistical difference in student reporting performance or perceptions of learning. Performance evaluations provided helpful insights for the nurse educator.

Symptom load and general function among patients with erythema migrans: a prospective study with a 1-year follow-up after antibiotic treatment in Norwegian general practice.

PubMed

Eliassen, Knut Eirik; Hjetland, Reidar; Reiso, Harald; Lindbæk, Morten; Tschudi-Madsen, Hedda

2017-03-01

Promptly treated erythema migrans (EM) has good prognosis. However, some patients report persistent symptoms. Do patients with EM have more symptoms than the general population? We describe individual symptoms and general function in EM-patients at time of diagnosis and one year after treatment. Prospective study with 1-year follow up after treatment. Questionnaires included a modified version of the Subjective Health Complaints Inventory, comprising three additional Lyme borreliosis (LB) related symptoms. General function was assessed using a five-point scale modified from the COOP/WONCA charts. Norwegian general practice. A total of 188 patients were included in a randomized controlled trial comparing three antibiotic regimens for EM, of whom 139 had complete data for this study. Individual symptoms, symptom load and general function. Mild symptoms were common, reported by 84.9% at baseline and by 85.6% at follow-up. At baseline, patients reported a mean of 5.4 symptoms, compared with 6.2 after one year. Severely bothersome symptoms and severely impaired general function were rare. Tiredness was the most reported symptom both at baseline and at follow-up. Palsy (other than facial) was the least reported symptom, but the only one with a significant increase. However, this was not associated to the EM. The symptom load was comparable to that reported in the general population. We found an increase in symptom load at follow-up that did not significantly affect general function. Monitoring patients' symptom loads prior to treatment reduce the probability of attributing follow-up symptoms to LB. Key points Erythema migrans has a good prognosis.Patients treated for erythema migrans have a slight increase in symptom load one year after treatment. This increase does not affect general function. The levels of subjective health complaints in patients treated for erythema migrans are comparable to the background population.

The relevance of applying exercise training principles when designing therapeutic interventions for patients with inflammatory myopathies: a systematic review.

PubMed

Baschung Pfister, Pierrette; de Bruin, Eling D; Tobler-Ammann, Bernadette C; Maurer, Britta; Knols, Ruud H

2015-10-01

Physical exercise seems to be a safe and effective intervention in patients with inflammatory myopathy (IM). However, the optimal training intervention is not clear. To achieve an optimum training effect, physical exercise training principles must be considered and to replicate research findings, FITT components (frequency, intensity, time, and type) of exercise training should be reported. This review aims to evaluate exercise interventions in studies with IM patients in relation to (1) the application of principles of exercise training, (2) the reporting of FITT components, (3) the adherence of participants to the intervention, and (4) to assess the methodological quality of the included studies. The literature was searched for exercise studies in IM patients. Data were extracted to evaluate the application of the training principles, the reporting of and the adherence to the exercise prescription. The Downs and Black checklist was used to assess methodological quality of the included studies. From the 14 included studies, four focused on resistance, two on endurance, and eight on combined training. In terms of principles of exercise training, 93 % reported specificity, 50 % progression and overload, and 79 % initial values. Reversibility and diminishing returns were never reported. Six articles reported all FITT components in the prescription of the training though no study described adherence to all of these components. Incomplete application of the exercise training principles and insufficient reporting of the exercise intervention prescribed and completed hamper the reproducibility of the intervention and the ability to determine the optimal dose of exercise.

Indonesia Cohort of IO HAT Study to Evaluate Diabetes Management, Control, and Complications in Retrospective and Prospective Periods Among Insulin-Treated Patients with Type 1 and Type 2 Diabetes.

PubMed

Rudijanto, Achmad; Saraswati, Made R; Yunir, Em; Kumala, Poppy; Puteri, Happy Hs; Mandang, Veny Vv

2018-01-01

hypoglycemia is a major adverse event of insulin therapy for diabetes mellitus patients. The study was conducted to evaluate the incidence of hypoglycemia among insulin treated patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) in the Indonesian cohort. this Indonesian cohort study consisted of retrospective and prospective evaluation of hypoglycemic episodes, using International Operations Hypoglycemia Assessment Tool (IO HAT) in 374 patients with diabetes (T1DM; n=17 or T2DM; n=357). The patients of ≥18 years of age and treated with insulin for >12 months were selected for this study (ClinicalTrials.gov number: NCT02306681). a total of 374 patients were enrolled in this study and completed SAQ1. All patients with T1DM (17 [100%]), and 347 (97.2%) patients with T2DM completed SAQ2. Almost all the patients in the 4-week prospective period reported at least one hypoglycemic event (T1DM 100%, T2DM 99.4%) and the incidence rate of any hypoglycemia was 67.5 events per patient-year (PPY) and 25.7 events PPY for T1DM and T2DM patients, respectively. Among patients with T1DM and T2DM, 5.9% and 36.4%, respectively, did not know what hypoglycemia was at baseline, also high proportion of patients had impaired hypoglycemic awareness in the study (82.4% and 62.7%, respectively). overall, high proportion of patients reported hypoglycemic events in the prospective period indicating under reporting during the retrospective period due to recall bias. Therefore, there is a need for patient education program to improve the awareness of hypoglycemia in diabetes patient in Indonesia.

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

PubMed

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

2016-01-01

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

Safety of meropenem in patients reporting penicillin allergy: lack of allergic cross reactions.

PubMed

Cunha, B A; Hamid, N S; Krol, V; Eisenstein, L

2008-04-01

Over the years, meropenem has become the mainstay of empiric therapy for serious systemic infections in critically ill patients. Although we have had extensive clinical experience since 1996 using meropenem safely in treating hundreds of patients with reported allergic reactions to penicillin without any adverse events, we have not published our experience. This study was conducted to document our clinical practice experience. Accordingly, over a 12-month period we prospectively monitored 110 patients treated with meropenem reporting penicillin allergic reactions for that 12-month period. Since early empiric therapy in such patients is essential, there is often no time for penicillin skin testing. Penicillin skin testing was not done in this "real world" clinical study. Patients were divided into two groups, depending on the nature of their penicillin allergic reactions. During a 12-month period, 110 patients with non-anaphylactic (59) and anaphylactic (51) penicillin allergic reactions tolerated prolonged meropenem therapy (1-4 weeks) safely without any allergic reactions. Based on these data and our previous clinical experience, there appears to be little/no potential cross reactivity between meropenem and penicillins even in patients with a definite history of anaphylactic reactions to penicillins. To the best of our knowledge, this is the first prospective clinical study demonstrating that meropenem may be safely given to patients with known/unknown allergic reactions to penicillin, including those with anaphylactic reactions, without penicillin skin testing. We conclude that meropenem may be given safely to patients reporting a history of non-anaphylactic or anaphylactic allergic reactions to penicillins without penicillin skin testing.

Improving the Usefulness and Use of Patient Survey Programs: National Health Service Interview Study

PubMed Central

Darzi, Ara; Gancarczyk, Sarah; Mayer, Erik

2018-01-01

Background A growing body of evidence suggests a concerning lag between collection of patient experience data and its application in service improvement. This study aims to identify what health care staff perceive to be the barriers and facilitators to using patient-reported feedback and showcase successful examples of doing so. Objective This study aimed to apply a systems perspective to suggest policy improvements that could support efforts to use data on the frontlines. Methods Qualitative interviews were conducted in eight National Health Service provider locations in the United Kingdom, which were selected based on National Inpatient Survey scores. Eighteen patient-experience leads were interviewed about using patient-reported feedback with relevant staff. Interviews were transcribed and underwent thematic analysis. Staff-identified barriers and facilitators to using patient experience feedback were obtained. Results The most frequently cited barriers to using patient reported feedback pertained to interpreting results, understanding survey methodology, presentation of data in both national Care Quality Commission and contractor reports, inability to link data to other sources, and organizational structure. In terms of a wish list for improved practice, staff desired more intuitive survey methodologies, the ability to link patient experience data to other sources, and more examples of best practice in patient experience improvement. Three organizations also provided examples of how they successfully used feedback to improve care. Conclusions Staff feedback provides a roadmap for policy makers to reconsider how data is collected and whether or not the national regulations on surveys and patient experience data are meeting the quality improvement needs of local organizations. PMID:29691207

Prevalence of Neurobehavioral, Social, and Emotional Dysfunction in Patients Treated for Childhood Craniopharyngioma: A Systematic Literature Review

PubMed Central

Zada, Gabriel; Kintz, Natalie; Pulido, Mario; Amezcua, Lilyana

2013-01-01

Background Craniopharyngiomas (CP) are locally invasive and frequently recurring neoplasms often resulting in neurological and endocrinological dysfunction in children. In addition, social-behavioral impairment is commonly reported following treatment for childhood CP, yet remains to be fully understood. The authors aimed to further characterize the prevalence of neurobehavioral, social, and emotional dysfunction in survivors of childhood craniopharyngiomas. Materials and Methods A systematic literature review was conducted in PubMed to identify studies formally assessing neurobehavioral, social, and emotional outcomes in patients treated for CP prior to 18 years of age. Studies published between the years 1990-2012 that reported the primary outcome (prevalence of neurobehavioral, social, emotional/affective dysfunction, and/or impaired quality of life (QoL)) in ≥10 patients were included. Results Of the 471 studies screened, 11 met inclusion criteria. Overall neurobehavioral dysfunction was reported in 51 of 90 patients (57%) with available data. Social impairment (i.e. withdrawal, internalizing behavior) was reported in 91 of 222 cases (41%). School dysfunction was reported in 48 of 136 patients (35%). Emotional/affective dysfunction was reported in 58 of 146 patients (40%), primarily consisting of depressive symptoms. Health related quality of life was affected in 49 of 95 patients (52%). Common descriptors of behavior in affected children included irritability, impulsivity, aggressiveness, and emotional outbursts. Conclusions Neurobehavioral, social, and emotional impairment is highly prevalent in survivors of childhood craniopharyngioma, and often affects quality of life. Thorough neurobehavioral/emotional screening and appropriate counseling is recommended in this population. Additional research is warranted to identify risk factors and treatment strategies for these disorders. PMID:24223703

Patient-reported racial/ethnic healthcare provider discrimination and medication intensification in the Diabetes Study of Northern California (DISTANCE).

PubMed

Lyles, Courtney R; Karter, Andrew J; Young, Bessie A; Spigner, Clarence; Grembowski, David; Schillinger, Dean; Adler, Nancy

2011-10-01

Racial/ethnic minority patients are more likely to report experiences with discrimination in the healthcare setting, potentially leading to reduced access to appropriate care; however, few studies evaluate reports of discrimination with objectively measured quality of care indicators. To evaluate whether patient-reported racial/ethnic discrimination by healthcare providers was associated with evidence of poorer quality care measured by medication intensification. Baseline data from the Diabetes Study of Northern California (DISTANCE), a random, race-stratified sample from the Kaiser Permanente Diabetes Registry from 2005-2006, including both survey and medical record data. Self-reported healthcare provider discrimination (from survey data) and medication intensification (from electronic prescription records) for poorly controlled diabetes patients (A1c ≥9.0%; systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg; low-density lipoprotein (LDL) ≥130 mg/dl). Of 10,409 eligible patients, 21% had hyperglycemia, 14% had hyperlipidemia, and 32% had hypertension. Of those with hyperglycemia, 59% had their medications intensified, along with 40% with hyperlipidemia, 33% with hypertension, and 47% in poor control of any risk factor. In adjusted log-binomial GEE models, discrimination was not associated with medication intensification [RR = 0.96 (95% CI: 0.74, 1.24) for hyperglycemia, RR = 1.23 (95% CI: 0.93, 1.63) for hyperlipidemia, RR = 1.06 (95% CI: 0.69, 1.61) for hypertension, and RR = 1.08 (95% CI: 0.88, 1.33) for the composite cohort]. We found no evidence that patient-reported healthcare discrimination was associated with less medication intensification. While not associated with this technical aspect of care, discrimination could still be associated with other aspects of care (e.g., patient-centeredness, communication).

Effect of extracorporeal shock wave therapy on scar pain in burn patients: A prospective, randomized, single-blind, placebo-controlled study.

PubMed

Cho, Yoon Soo; Joo, So Young; Cui, Huisong; Cho, Sung-Rae; Yim, Haejun; Seo, Cheong Hoon

2016-08-01

Extracorporeal shock wave therapy (ESWT) has been used to reduce pain in patients with various musculoskeletal diseases and wounds. We investigated the effect of ESWT on scar pain after complete wound epithelialization in burn patients. A prospective, single-blind, placebo-controlled study was conducted from February 2014 to 2015. Forty patients with burn scar pain despite standard therapy (medication, physical therapy, and burn rehabilitation massage therapy) were randomized into ESWT or control (sham ESWT) groups. ESWT was administered at 100 impulses/cm (0.05-0.15 mJ/mm) once per week for 3 weeks. The treatment effects were assessed using the numerical rating scale (NRS), pain threshold, Nirschl pain phase system, and Roles and Maudsley scores. The characteristics of patients between the 2 study groups were balanced (P >0.05) for age, sex, and total burn surface area (%). In both groups, the NRS, pain threshold (Ib/cm), and Nirschl pain phase system values significantly improved (P <0.05) after 3 sessions of ESWT or sham therapy, and there were significant differences between the 2 groups in terms of these 3 variables (P <0.001, P <0.001, P = 0.013, respectively). The Roles and Maudsley scores significantly improved; among 20 patients, 17 reported a score of poor (85%) and 3 reported fair (15%) before ESWT, whereas 3 reported poor (15%), 8 reported fair (40%), 5 reported good (25%), and 4 reported excellent (20%) after ESWT (P = 0.004). The scores did not improve in the control group (P = 0.128). ESWT significantly reduced scar pain in burn patients after wound recovery.

Treatment of dissociative disorders and reported changes in inpatient and outpatient cost estimates

PubMed Central

Myrick, Amie C.; Webermann, Aliya R.; Langeland, Willemien; Putnam, Frank W.; Brand, Bethany L.

2017-01-01

ABSTRACT Background: Interpersonal trauma and trauma-related disorders cost society billions of dollars each year. Because of chronic and severe trauma histories, dissociative disorder (DD) patients spend many years in the mental health system, yet there is limited knowledge about the economic burden associated with DDs. Objective: The current study sought to determine how receiving specialized treatment would relate to estimated costs of inpatient and outpatient mental health services. Method: Patients’ and individual therapists’ reports of inpatient hospitalization days and outpatient treatment sessions were converted into US dollars. DD patients and their clinicians reported on use of inpatient and outpatient services four times over 30 months as part of a larger, naturalistic, international DD treatment study. The baseline sample included 292 clinicians and 280 patients; at the 30-month follow-up, 135 clinicians and 111 patients. Missing data were replaced in analyses to maintain adequate statistical power. The substantial attrition rate (>50%) should be considered in interpreting findings. Results: Longitudinal and cross-sectional analyses of cost estimates based on patient reported inpatient hospitalization significantly decreased over time. Longitudinal cost estimates based on clinician-reported outpatient services also significantly decreased over time. Cross-sectional cost estimates based on patient and clinician reported inpatient hospitalization were significantly lower for patients in later stages of treatment compared to those struggling with safety and stabilization. Cross-sectional cost estimates based on clinician-reported outpatient services were significantly lower for patients in later stages of treatment compared to those in early stages. Conclusions: This pattern of longitudinal and cross-sectional reductions in inpatient and outpatient costs, as reported by both patients and therapists, suggests that DD treatment may be associated with reduced inpatient and outpatient costs over time. Although these preliminary results show decreased mental health care utilization and associated estimated costs, it is not clear whether it was treatment that caused these important changes. PMID:29038681

Patients' characteristics informing practice: improving individualized nursing care in the radiation oncology setting.

PubMed

Rose, Pauline M

2018-05-04

A large number of patients attend for radiotherapy daily. Primary nurses in the study settings aim to individualize care for their patients. The individual characteristics of patients may determine their perceptions of nursing care, and provide guidance in tailoring their care. This study aimed to assess patients' personal characteristics on their perceptions of individualized care (IC) provided by nurses during a course of radiotherapy, and to determine predictor variables that may inform nursing practice. This cross-sectional, exploratory study was conducted in three radiotherapy departments in Australia. Patients (n = 250) completed the Individualized Care Scale_Patient (ICS_P). Data were analyzed using descriptive and inferential statistics, univariate analysis, and multiple regression analysis. Males reported significantly higher perceptions of IC than females in 7/9 subscales. Patients with head and neck and prostate cancer, as well as those requiring hospitalization during radiotherapy, scored significantly higher in 5/9 subscales. Courses > 30 days, those not receiving chemotherapy, and partnered patients reported greater IC across all subscales. Gender and hospitalization were the main predictor variables for IC. Patients reported moderately high levels of IC during their radiotherapy; however, standard demographic information may provide limited insight into improving care for the individual. Patient characteristics routinely chosen, such as age, gender, and education may not predict how patients perceive their care or support the tailoring of interventions to improve IC. Researching a range of related patient characteristics may prove a more useful concept for future nursing studies aiming to predict outcomes to tailor nursing practice.

Non-dreamers.

PubMed

Pagel, J F

2003-05-01

Assess incidence and clarify whether diagnostic correlates exist for sleep laboratory patients reporting a lack of dream recall. To awaken, during polysomnographically defined sleep including rapid eye movement (REM) sleep, individuals reporting never having experienced a dream, and determine whether they report dreaming. Study # 1 - Incidence and polysomnographic correlates of sleep lab patients responding on questionnaire that they had never experienced dreaming. Study # 2 - Phone interviews with those individuals reporting non-dreaming on questionnaire to reassess incidence. Study # 3 - After reassessment, individuals (non-dreamers - # 16) are awakened during polysomnographic defined sleep (including REM sleep) and queried about dream recall. This group is compared statistically to a group (rare-dreamers - # 12) that reported dreaming as an extremely rare occurrence (mean dream recall latency - 13.5 years). Study # 1: Incidence of questionnaire reported non-dreaming in this sleep laboratory population is 6.5% (N=534) and is associated with the diagnosis of obstructive sleep apnea (specificity 95.6% for respiratory disturbance index >15). Study # 2 - Individuals who report after interview to have never experienced dreaming are more unusual (0.38% of this sleep laboratory population). Study # 3 - None of the non-dreamers (# 16) reported dream recall after waking in the sleep laboratory (36 awakenings in total for this group). This group does not differ, based on polysomnographic, clinical, or demographic variables, from the rare-dreaming group that occasionally reported dreams when awakened (3/12 patients, 3/32 awakenings) - a finding consistent with the reports of previous studies. The experience of dreaming may not be as ubiquitous as generally accepted. The group of non-dreamers evaluated in this study reports never having recalled a dream and reports no dreams when awakened during polysomnographicly defined sleep. These individuals might not experience dreaming.

PedsQL™ Multidimensional Fatigue Scale in sickle cell disease: feasibility, reliability, and validity.

PubMed

Panepinto, Julie A; Torres, Sylvia; Bendo, Cristiane B; McCavit, Timothy L; Dinu, Bogdan; Sherman-Bien, Sandra; Bemrich-Stolz, Christy; Varni, James W

2014-01-01

Sickle cell disease (SCD) is an inherited blood disorder characterized by a chronic hemolytic anemia that can contribute to fatigue and global cognitive impairment in patients. The study objective was to report on the feasibility, reliability, and validity of the PedsQL™ Multidimensional Fatigue Scale in SCD for pediatric patient self-report ages 5-18 years and parent proxy-report for ages 2-18 years. This was a cross-sectional multi-site study whereby 240 pediatric patients with SCD and 303 parents completed the 18-item PedsQL™ Multidimensional Fatigue Scale. Participants also completed the PedsQL™ 4.0 Generic Core Scales. The PedsQL™ Multidimensional Fatigue Scale evidenced excellent feasibility, excellent reliability for the Total Scale Scores (patient self-report α = 0.90; parent proxy-report α = 0.95), and acceptable reliability for the three individual scales (patient self-report α = 0.77-0.84; parent proxy-report α = 0.90-0.97). Intercorrelations of the PedsQL™ Multidimensional Fatigue Scale with the PedsQL™ Generic Core Scales were predominantly in the large (≥0.50) range, supporting construct validity. PedsQL™ Multidimensional Fatigue Scale Scores were significantly worse with large effects sizes (≥0.80) for patients with SCD than for a comparison sample of healthy children, supporting known-groups discriminant validity. Confirmatory factor analysis demonstrated an acceptable to excellent model fit in SCD. The PedsQL™ Multidimensional Fatigue Scale demonstrated acceptable to excellent measurement properties in SCD. The results demonstrate the relative severity of fatigue symptoms in pediatric patients with SCD, indicating the potential clinical utility of multidimensional assessment of fatigue in patients with SCD in clinical research and practice. © 2013 Wiley Periodicals, Inc.

PedsQL™ Multidimensional Fatigue Scale in Sickle Cell Disease: Feasibility, Reliability and Validity

PubMed Central

Panepinto, Julie A.; Torres, Sylvia; Bendo, Cristiane B.; McCavit, Timothy L.; Dinu, Bogdan; Sherman-Bien, Sandra; Bemrich-Stolz, Christy; Varni, James W.

2013-01-01

Background Sickle cell disease (SCD) is an inherited blood disorder characterized by a chronic hemolytic anemia that can contribute to fatigue and global cognitive impairment in patients. The study objective was to report on the feasibility, reliability, and validity of the PedsQL™ Multidimensional Fatigue Scale in SCD for pediatric patient self-report ages 5–18 years and parent proxy-report for ages 2–18 years. Procedure This was a cross-sectional multi-site study whereby 240 pediatric patients with SCD and 303 parents completed the 18-item PedsQL™ Multidimensional Fatigue Scale. Participants also completed the PedsQL™ 4.0 Generic Core Scales. Results The PedsQL™ Multidimensional Fatigue Scale evidenced excellent feasibility, excellent reliability for the Total Scale Scores (patient self-report α = 0.90; parent proxy-report α = 0.95), and acceptable reliability for the three individual scales (patient self-report α = 0.77–0.84; parent proxy-report α = 0.90–0.97). Intercorrelations of the PedsQL™ Multidimensional Fatigue Scale with the PedsQL™ Generic Core Scales were predominantly in the large (≥ 0.50) range, supporting construct validity. PedsQL™ Multidimensional Fatigue Scale Scores were significantly worse with large effects sizes (≥0.80) for patients with SCD than for a comparison sample of healthy children, supporting known-groups discriminant validity. Confirmatory factor analysis demonstrated an acceptable to excellent model fit in SCD. Conclusions The PedsQL™ Multidimensional Fatigue Scale demonstrated acceptable to excellent measurement properties in SCD. The results demonstrate the relative severity of fatigue symptoms in pediatric patients with SCD, indicating the potential clinical utility of multidimensional assessment of fatigue in patients with SCD in clinical research and practice. PMID:24038960

Patient centred care for the medical treatment of lower urinary tract symptoms in patients with benign prostatic obstruction: a key point to improve patients' care - a systematic review.

PubMed

De Nunzio, Cosimo; Presicce, Fabrizio; Lombardo, Riccardo; Trucchi, Alberto; Bellangino, Mariangela; Tubaro, Andrea; Moja, Egidio

2018-06-26

Even though evidence based medicine, guidelines and algorithms still represent the pillars of the management of chronic diseases (i.e: hypertension, diabetes mellitus), a patient centred approach has been recently proposed as a successful strategy, in particular to improve drug adherence. Aim of the present review is to evaluate the unmet needs in LUTS/BPH management and the possible impact of a patient centered approach in this setting. A National Center for Biotechnology Information (NCBI) PubMed search for relevant articles published from January 2000 until December 2016 was performed by combining the following MESH terms: patients centred medicine, patient centered care, person centered care, patient centered outcomes, value based care, shared decision making, male, Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia, treatment. We followed the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA). All studies reporting on patient centred approach, shared decision making and evidence-based medicine were included in the review. All original article, reviews, letters, congress abstracts, and editorials comments were included in the review. Studies reporting single case reports, experimental studies on animal models and studies not in English were not included in the review. Overall 751 abstracts were reviewed, out of them 87 full texts were analysed resulting in 36 papers included. The evidence summarised in this systematic review confirmed how a patient centred visit may improve patient's adherence to medication. Although a patient centred model has been rarely used in urology, management of Low Urinary Tract Symptoms (LUTS) and Benign Prostatic Obstruction (BPO) may represent the perfect ground to experiment and improve this approach. Notwithstanding all the innovations in LUTS/BPO medical treatment, the real life picture is far from ideal. Recent evidence shows a dramatical low drug adherence and satisfaction to medical treatment in LUTS/BPH patients. A patient centred approach may improve drug adherence and some unmet needs in this area, potentially reducing complications and costs. However further well designed studies are needed to confirm this data.

Trainees May Add Value to Patient Care by Decreasing Addendum Utilization in Radiology Reports.

PubMed

Balthazar, Patricia; Konstantopoulos, Christina; Wick, Carson A; DeSimone, Ariadne K; Tridandapani, Srini; Simoneaux, Stephen; Applegate, Kimberly E

2017-11-01

The purpose of this study was to evaluate the impact of trainee involvement and other factors on addendum rates in radiology reports. This retrospective study was performed in a tertiary care pediatric hospital. From the institutional radiology data repository, we extracted all radiology reports from January 1 to June 30, 2016, as well as trainee (resident or fellow) involvement, imaging modality, patient setting (emergency, inpatient, or outpatient), order status (routine vs immediate), time of interpretation (regular work hours vs off-hours), radiologist's years of experience, and sex. We grouped imaging modalities as advanced (CT, MRI, and PET) or nonadvanced (any modality that was not CT, MRI, or PET) and radiologist experience level as ≤ 20 years or > 20 years. Our outcome measure was the rate of addenda in radiology reports. Statistical analysis was performed using multivariate logistic regression. From 129,033 reports finalized during the study period, 418 (0.3%) had addenda. Reports generated without trainees were 12 times more likely than reports with trainee involvement to have addenda (odds ratio [OR] = 12.2, p < 0.001). Advanced imaging studies were more likely than nonadvanced studies to be associated with addendum use (OR = 4.7, p < 0.001). Reports generated for patients in emergency or outpatient settings had a slightly higher likelihood of addendum use than those in an inpatient setting (OR = 1.5, p = 0.04; and OR = 1.3, p = 0.04, respectively). Routine orders had a slightly higher likelihood of addendum use compared with immediate orders (OR = 1.3, p = 0.01). We found no difference in addendum use by radiologist's sex, radiologist's years of experience, emergency versus outpatient setting, or time of interpretation. Trainees may add value to patient care by decreasing addendum rates in radiology reports.

Use of complementary and alternative medicine among patients: classification criteria determine level of use.

PubMed

Kristoffersen, Agnete Egilsdatter; Fønnebø, Vinjar; Norheim, Arne Johan

2008-10-01

Self-reported use of complementary and alternative medicine (CAM) among patients varies widely between studies, possibly because the definition of a CAM user is not comparable. This makes it difficult to compare studies. The aim of this study is to present a six-level model for classifying patients' reported exposure to CAM. Prayer, physical exercise, special diets, over-the-counter products/CAM techniques, and personal visits to a CAM practitioner are successively removed from the model in a reductive fashion. By applying the model to responses given by Norwegian patients with cancer, we found that 72% use CAM if the user was defined to include all types of CAM. This proportion was reduced successively to only 11% in the same patient group when a CAM user was defined as a user visiting a CAM practitioner four or more times. When considering a sample of 10 recently published studies of CAM use among patients with breast cancer, we found 98% use when the CAM user was defined to include all sorts of CAM. This proportion was reduced successively to only 20% when a CAM user was defined as a user of a CAM practitioner. We recommend future surveys of CAM use to report at more than one level and to clarify which intensity level of CAM use the report is based on.

Training hospital staff on spiritual care in palliative care influences patient-reported outcomes: Results of a quasi-experimental study.

PubMed

van de Geer, Joep; Groot, Marieke; Andela, Richtsje; Leget, Carlo; Prins, Jelle; Vissers, Kris; Zock, Hetty

2017-09-01

Spiritual care is reported to be important to palliative patients. There is an increasing need for education in spiritual care. To measure the effects of a specific spiritual care training on patients' reports of their perceived care and treatment. A pragmatic controlled trial conducted between February 2014 and March 2015. The intervention was a specific spiritual care training implemented by healthcare chaplains to eight multidisciplinary teams in six hospitals on regular wards in which patients resided in both curative and palliative trajectories. In total, 85 patients were included based on the Dutch translation of the Supportive and Palliative Care Indicators Tool. Data were collected in the intervention and control wards pre- and post-training using questionnaires on physical symptoms, spiritual distress, involvement and attitudes (Spiritual Attitude and Involvement List) and on the perceived focus of healthcare professionals on patients' spiritual needs. All 85 patients had high scores on spiritual themes and involvement. Patients reported that attention to their spiritual needs was very important. We found a significant ( p = 0.008) effect on healthcare professionals' attention to patients' spiritual and existential needs and a significant ( p = 0.020) effect in favour of patients' sleep. No effect on the spiritual distress of patients or their proxies was found. The effects of spiritual care training can be measured using patient-reported outcomes and seemed to indicate a positive effect on the quality of care. Future research should focus on optimizing the spiritual care training to identify the most effective elements and developing strategies to ensure long-term positive effects. This study was registered at the Dutch Trial Register: NTR4559.

Patients' perceptions of sharing in decisions: a systematic review of interventions to enhance shared decision making in routine clinical practice.

PubMed

Légaré, France; Turcotte, Stéphane; Stacey, Dawn; Ratté, Stéphane; Kryworuchko, Jennifer; Graham, Ian D

2012-01-01

Shared decision making is the process in which a healthcare choice is made jointly by the health professional and the patient. Little is known about what patients view as effective or ineffective strategies to implement shared decision making in routine clinical practice. This systematic review evaluates the effectiveness of interventions to improve health professionals' adoption of shared decision making in routine clinical practice, as seen by patients. We searched electronic databases (PubMed, the Cochrane Library, EMBASE, CINAHL, and PsycINFO) from their inception to mid-March 2009. We found additional material by reviewing the reference lists of the studies found in the databases; systematic reviews of studies on shared decision making; the proceedings of various editions of the International Shared Decision Making Conference; and the transcripts of the Society for Medical Decision Making's meetings. In our study selection, we included randomized controlled trials, controlled clinical trials, controlled before-and-after studies, and interrupted time series analyses in which patients evaluated interventions to improve health professionals' adoption of shared decision making. The interventions in question consisted of the distribution of printed educational material; educational meetings; audit and feedback; reminders; and patient-mediated initiatives (e.g. patient decision aids). Two reviewers independently screened the studies and extracted data. Statistical analyses considered categorical and continuous process measures. We computed the standardized effect size for each outcome at the 95% confidence interval. The primary outcome of interest was health professionals' adoption of shared decision making as reported by patients in a self-administered questionnaire. Of the 6764 search results, 21 studies reported 35 relevant comparisons. Overall, the quality of the studies ranged from 0% to 83%. Only three of the 21 studies reported a clinically significant effect for the primary outcome that favored the intervention. The first study compared an educational meeting and a patient-mediated intervention with another patient-mediated intervention (median improvement of 74%). The second compared an educational meeting, a patient-mediated intervention, and audit and feedback with an educational meeting on an alternative topic (improvement of 227%). The third compared an educational meeting and a patient-mediated intervention with usual care (p = 0.003). All three studies were limited to the patient-physician dyad. To reduce bias, future studies should improve methods and reporting, and should analyze costs and benefits, including those associated with training of health professionals. Multifaceted interventions that include educating health professionals about sharing decisions with patients and patient-mediated interventions, such as patient decision aids, appear promising for improving health professionals' adoption of shared decision making in routine clinical practice as seen by patients.

Outcome after one year of upper airway stimulation for obstructive sleep apnea in a multicenter German post-market study.

PubMed

Steffen, Armin; Sommer, J Ulrich; Hofauer, Benedikt; Maurer, Joachim T; Hasselbacher, Katrin; Heiser, Clemens

2018-02-01

Upper airway stimulation (UAS) of the hypoglossal nerve has been implemented in the routine clinical practice for patients with moderate-to-severe obstructive sleep apnea (OSA) who could not adhere to continuous positive airway pressure. This study reports objective and patient-reported outcome after 12 months of implantation. Multicenter prospective single-arm study. Consecutive patients who received the UAS system (Inspire Medical Systems, Inc., Minneapolis, Minnesota, Maple Grove, MN, U.S.A.) were enrolled in three German centers. Key study exclusion criteria included body mass index > 35 kg/m 2 , apnea-hypopnea index (AHI) < 15 or > 65, or complete concentric collapse at the soft palate during sedated endoscopy. Data collection at 6- and 12-month visit include home sleep test and patient-reported outcome measures. Among the total of 60 participants, the median AHI reduced from 28.6 to 9.5 from baseline to 12 months. Patient-reported outcome measured in Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire both improved significantly from baseline to 12 months. The average usage time was 39.1 ± 14.9 hours per week among all participants based on recordings by the implanted device. One patient requested a removal of the device for cosmetic and other personal reasons and was completed without sequelae. This study supported that UAS is a safe and effective treatment option for patients with OSA in routine clinical practice. 4. Laryngoscope, 128:509-515, 2018. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

Anesthetic Management of Narcolepsy Patients During Surgery: A Systematic Review.

PubMed

Hu, Sally; Singh, Mandeep; Wong, Jean; Auckley, Dennis; Hershner, Shelley; Kakkar, Rahul; Thorpy, Michael J; Chung, Frances

2018-01-01

Narcolepsy is a rare sleep disorder characterized by excessive daytime sleepiness, sleep paralysis, and/or hypnagogic/hypnopompic hallucinations, and in some cases cataplexy. The response to anesthetic medications and possible interactions in narcolepsy patients is unclear in the perioperative period. In this systematic review, we aim to evaluate the current evidence on the perioperative outcomes and anesthetic considerations in narcolepsy patients. Electronic literature search of Medline, Medline in-process, Embase, Cochrane Database of Systematic Reviews databases, international conference proceedings, and abstracts was conducted in November 2015 according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols guideline. A total of 3757 articles were screened using a 2-stage strategy (title-abstract followed by full text). We included case studies/series, cohort studies, and randomized controlled trials of narcolepsy patients undergoing surgical procedures under anesthesia or sedation. Preoperative narcolepsy symptoms and sleep study data, anesthetic technique, and perioperative complications were extracted. Screening of articles, data extraction, and compilation were conducted by 2 independent reviewers and any conflict was resolved by the senior author. A total of 19 studies including 16 case reports and 3 case series were included and evaluated. The majority of these patients received general anesthesia, whereas a small percentage of patients received regional anesthesia. Reported complications of narcolepsy patients undergoing surgeries were mainly related to autonomic dysregulation, or worsening of narcolepsy symptoms intra/postoperatively. Narcolepsy symptoms worsened only in those patient populations where the preoperative medications were either discontinued or reduced (mainly in obstetric patients). In narcolepsy patients, use of depth of anesthesia monitoring and total intravenous technique may have some advantage in terms of safety profile. Several patients undergoing neurosurgery involving the hypothalamus or third or four ventricles developed new-onset narcolepsy. We found a paucity of prospective clinical trials in this patient population, as most of the studies were case reports or observational studies. Continuation of preoperative medications, depth of anesthesia monitoring, use of multimodal analgesia with short-acting agents and regional anesthesia techniques were associated with favorable outcomes. Obstetric patients may be at greater risk for worsening narcolepsy symptoms, possibly related to a reduction or discontinuation of medications. For neurosurgical procedures involving the hypothalamus or third and fourth ventricle, postoperative considerations should include monitoring for symptoms of narcolepsy. Future studies are needed to better define perioperative risks associated with anesthesia and surgery in this population of patients.

The CARE guidelines: consensus-based clinical case reporting guideline development

PubMed Central

Gagnier, Joel J; Kienle, Gunver; Altman, Douglas G; Moher, David; Sox, Harold; Riley, David

2013-01-01

A case report is a narrative that describes, for medical, scientific or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Develop, disseminate and implement systematic reporting guidelines for case reports. We used a three-phase consensus process consisting of (1) premeeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines and (3) postmeeting feedback, review and pilot testing, followed by finalisation of the case report guidelines. This consensus process involved 27 participants and resulted in a 13-item checklist—a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective and informed consent. We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery. PMID:24155002

Prevalence of sleep breathing complaints reported by treatment-seeking chronic insomnia disorder patients on presentation to a sleep medical center: a preliminary report.

PubMed

Krakow, Barry; Ulibarri, Victor A

2013-03-01

Few studies have examined the co-morbidity between insomnia and sleep-disordered breathing in the clinical setting. This study evaluated treatment-seeking insomnia patients and their self-report of sleep breathing complaints. A retrospective chart review was conducted on 1,035 consecutive treatment-seeking, chronic insomnia patients who reported insomnia as their primary problem upon seeking care at a private, community-based sleep medical center. Measurements included the insomnia severity index, standard subjective sleep measures as well as rankings, attributions, and self-reports about sleep breathing disorders, problems, and symptoms. A total of 1,035 adult, treatment-seeking insomnia patients indicated insomnia interfered with daytime functioning, and their average insomnia severity was in the range of a clinically relevant problem: total sleep time (5.50 h, SD = 1.60), sleep efficiency (71.05 %, SD = 18.26), wake time after sleep onset (120.70 min, SD = 92.56), and an insomnia severity index (18.81, SD = 5.09). Of these 1,035 insomnia patients, 42 % also ranked a sleep breathing disorder among their list of reasons for seeking treatment, another 13 % revealed a concern about a sleep breathing problem, and another 26 % reported awareness of sleep breathing symptoms. Only 19 % of this clinical insomnia sample reported no awareness or concerns about sleep breathing disorders, problems, or symptoms. A greater proportion of men than women reported significantly more sleep breathing disorders, problems, or symptoms. Sleep breathing complaints were extremely common among a large sample of treatment-seeking, self-identified, adult chronic insomnia patients. Prospective prevalence research is needed to corroborate or revise these findings, and polysomnography should be considered in appropriate cohorts to determine the clinical relevance of treatment-seeking chronic insomnia patients' sleep breathing complaints.

Clinical Outcome, Social Impact and Patient Expectation: a Purposive Sampling Pilot Evaluation of Patients in Benin Seven Years After Surgery.

PubMed

White, Michelle C; Randall, Kirsten; Avara, Esther; Mullis, Jenny; Parker, Gary; Shrime, Mark G

2018-05-01

Access to affordable and timely surgery is not equitable around the world. Five billion people lack access, and while non-governmental organizations (NGOs) help to meet this need, long-term surgical outcomes, social impact or patient experience is rarely reported. In 2016, Mercy Ships, a surgical NGO, undertook an evaluation of patients who had received surgery seven years earlier with Mercy Ships in 2009 in Benin. Using purposive sampling, patients who had received maxillofacial, plastics or orthopedic surgery were invited to attend a surgical evaluation day. In this pilot study, we used semi-structured interviews and questionnaire responses to assess patient expectation, surgical and social outcome. Our results show that seven years after surgery 35% of patients report surgery-related pain and 18% had sought further care for a clinical complication of their condition. However, 73% of patients report gaining social benefit from surgery, and overall patient satisfaction was 89%, despite 35% of patients saying that they were unclear what to expect after surgery indicating a mismatch of doctor/patient expectations and failure of the consent process. In conclusion, our pilot study shows that NGO surgery in Benin provided positive social impact associated with complication rates comparable to high-income countries when assessed seven years later. Key areas for further study in LMICs are: evaluation and treatment of chronic pain, consent and access to further care.

Electronic symptom reporting between patient and provider for improved health care service quality: a systematic review of randomized controlled trials. part 1: state of the art.

PubMed

Johansen, Monika Alise; Henriksen, Eva; Horsch, Alexander; Schuster, Tibor; Berntsen, Gro K Rosvold

2012-10-03

Over the last two decades, the number of studies on electronic symptom reporting has increased greatly. However, the field is very heterogeneous: the choices of patient groups, health service innovations, and research targets seem to involve a broad range of foci. To move the field forward, it is necessary to build on work that has been done and direct further research to the areas holding most promise. Therefore, we conducted a comprehensive review of randomized controlled trials (RCTs) focusing on electronic communication between patient and provider to improve health care service quality, presented in two parts. Part 2 investigates the methodological quality and effects of the RCTs, and demonstrates some promising benefits of electronic symptom reporting. To give a comprehensive overview of the most mature part of this emerging field regarding (1) patient groups, (2) health service innovations, and (3) research targets relevant to electronic symptom reporting. We searched Medline, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and IEEE Xplore for original studies presented in English-language articles published from 1990 to November 2011. Inclusion criteria were RCTs of interventions where patients or parents reported health information electronically to the health care system for health care purposes and were given feedback. Of 642 records identified, we included 32 articles representing 29 studies. The included articles were published from 2002, with 24 published during the last 5 years. The following five patient groups were represented: respiratory and lung diseases (12 studies), cancer (6), psychiatry (6), cardiovascular (3), and diabetes (1). In addition to these, 1 study had a mix of three groups. All included studies, except 1, focused on long-term conditions. We identified four categories of health service innovations: consultation support (7 studies), monitoring with clinician support (12), self-management with clinician support (9), and therapy (1). Most of the research (21/29, 72%) was conducted within four combinations: consultation support innovation in the cancer group (5/29, 17%), monitoring innovation in the respiratory and lung diseases group (8/29, 28%), and self-management innovations in psychiatry (4/29, 14%) and in the respiratory and lung diseases group (4/29, 14%). Research targets in the consultation support studies focused on increased patient centeredness, while monitoring and self-management mainly aimed at documenting health benefits. All except 1 study aiming for reduced health care costs were in the monitoring group. RCT-based research on electronic symptom reporting has developed enormously since 2002. Research including additional patient groups or new combinations of patient groups with the four identified health service innovations can be expected in the near future. We suggest that developing a generic model (not diagnosis specific) for electronic patient symptom reporting for long-term conditions may benefit the field.

Electronic Symptom Reporting Between Patient and Provider for Improved Health Care Service Quality: A Systematic Review of Randomized Controlled Trials. Part 1: State of the Art

PubMed Central

Henriksen, Eva; Horsch, Alexander; Schuster, Tibor; Berntsen, Gro K Rosvold

2012-01-01

Background Over the last two decades, the number of studies on electronic symptom reporting has increased greatly. However, the field is very heterogeneous: the choices of patient groups, health service innovations, and research targets seem to involve a broad range of foci. To move the field forward, it is necessary to build on work that has been done and direct further research to the areas holding most promise. Therefore, we conducted a comprehensive review of randomized controlled trials (RCTs) focusing on electronic communication between patient and provider to improve health care service quality, presented in two parts. Part 2 investigates the methodological quality and effects of the RCTs, and demonstrates some promising benefits of electronic symptom reporting. Objective To give a comprehensive overview of the most mature part of this emerging field regarding (1) patient groups, (2) health service innovations, and (3) research targets relevant to electronic symptom reporting. Methods We searched Medline, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and IEEE Xplore for original studies presented in English-language articles published from 1990 to November 2011. Inclusion criteria were RCTs of interventions where patients or parents reported health information electronically to the health care system for health care purposes and were given feedback. Results Of 642 records identified, we included 32 articles representing 29 studies. The included articles were published from 2002, with 24 published during the last 5 years. The following five patient groups were represented: respiratory and lung diseases (12 studies), cancer (6), psychiatry (6), cardiovascular (3), and diabetes (1). In addition to these, 1 study had a mix of three groups. All included studies, except 1, focused on long-term conditions. We identified four categories of health service innovations: consultation support (7 studies), monitoring with clinician support (12), self-management with clinician support (9), and therapy (1). Most of the research (21/29, 72%) was conducted within four combinations: consultation support innovation in the cancer group (5/29, 17%), monitoring innovation in the respiratory and lung diseases group (8/29, 28%), and self-management innovations in psychiatry (4/29, 14%) and in the respiratory and lung diseases group (4/29, 14%). Research targets in the consultation support studies focused on increased patient centeredness, while monitoring and self-management mainly aimed at documenting health benefits. All except 1 study aiming for reduced health care costs were in the monitoring group. Conclusion RCT-based research on electronic symptom reporting has developed enormously since 2002. Research including additional patient groups or new combinations of patient groups with the four identified health service innovations can be expected in the near future. We suggest that developing a generic model (not diagnosis specific) for electronic patient symptom reporting for long-term conditions may benefit the field. PMID:23032300

Active albuterol or placebo, sham acupuncture, or no intervention in asthma.

PubMed

Wechsler, Michael E; Kelley, John M; Boyd, Ingrid O E; Dutile, Stefanie; Marigowda, Gautham; Kirsch, Irving; Israel, Elliot; Kaptchuk, Ted J

2011-07-14

In prospective experimental studies in patients with asthma, it is difficult to determine whether responses to placebo differ from the natural course of physiological changes that occur without any intervention. We compared the effects of a bronchodilator, two placebo interventions, and no intervention on outcomes in patients with asthma. In a double-blind, crossover pilot study, we randomly assigned 46 patients with asthma to active treatment with an albuterol inhaler, a placebo inhaler, sham acupuncture, or no intervention. Using a block design, we administered one each of these four interventions in random order during four sequential visits (3 to 7 days apart); this procedure was repeated in two more blocks of visits (for a total of 12 visits by each patient). At each visit, spirometry was performed repeatedly over a period of 2 hours. Maximum forced expiratory volume in 1 second (FEV(1)) was measured, and patients' self-reported improvement ratings were recorded. Among the 39 patients who completed the study, albuterol resulted in a 20% increase in FEV(1), as compared with approximately 7% with each of the other three interventions (P<0.001). However, patients' reports of improvement after the intervention did not differ significantly for the albuterol inhaler (50% improvement), placebo inhaler (45%), or sham acupuncture (46%), but the subjective improvement with all three of these interventions was significantly greater than that with the no-intervention control (21%) (P<0.001). Although albuterol, but not the two placebo interventions, improved FEV(1) in these patients with asthma, albuterol provided no incremental benefit with respect to the self-reported outcomes. Placebo effects can be clinically meaningful and can rival the effects of active medication in patients with asthma. However, from a clinical-management and research-design perspective, patient self-reports can be unreliable. An assessment of untreated responses in asthma may be essential in evaluating patient-reported outcomes. (Funded by the National Center for Complementary and Alternative Medicine.).

Worse self-reported outcomes but no limitations in performance-based measures in patients with long-standing hip and groin pain compared with healthy controls.

PubMed

Wörner, Tobias; Sigurðsson, Haraldur B; Pålsson, Anders; Kostogiannis, Ioannis; Ageberg, Eva

2017-01-01

This study aimed to evaluate patient-reported outcomes as well as lower extremity and trunk muscle function in patients with long-standing hip and groin pain, in comparison with matched, healthy controls. It was hypothesized that patients with long-standing hip and groin pain would report more deficiency on the Copenhagen Hip and Groin Outcome Score (HAGOS) and have worse outcomes on performance-based measures than healthy controls. Nineteen patients with long-standing hip and groin pain and 19 healthy, activity level-, age-, gender-, and weight-matched controls were assessed with the HAGOS for self-reported outcomes, and a parallel squat (w/kg), single-leg triple jump (cm), single-leg rise (n), barbell roll-out (% of height), and plank test (s) for performance-based measures. Independent sample t test was performed to assess between-group differences. The paired t test was used to analyse between-limb differences in unilateral performance tasks. The patients had worse scores than the controls in all HAGOS subscales (p ≤ 0.001), while no statistically significant differences were observed for any performance measure between groups or between symptomatic and non-symptomatic limbs. Despite significant self-reported functional limitations on the HAGOS, there were no significant differences between groups in performance-based strength or power measures. The results of this study highlight the need to identify performance-based measures, sensitive to functional deficiencies in patients with long-standing hip and groin pain in order to complement the clinical picture obtained by patient-reported outcomes such as the HAGOS. III.

News media reports of patient deaths following 'medical tourism' for cosmetic surgery and bariatric surgery.

PubMed

Turner, Leigh

2012-04-01

Contemporary scholarship examining clinical outcomes in medical travel for cosmetic surgery identifies cases in which patients traveled abroad for medical procedures and subsequently returned home with infections and other surgical complications. Though there are peer-reviewed articles identifying patient deaths in cases where patients traveled abroad for commercial kidney transplantation or stem cell injections, no scholarly publications document deaths of patients who traveled abroad for cosmetic surgery or bariatric surgery. Drawing upon news media reports extending from 1993 to 2011, this article identifies and describes twenty-six reported cases of deaths of individuals who traveled abroad for cosmetic surgery or bariatric surgery. Over half of the reported deaths occurred in two countries. Analysis of these news reports cannot be used to make causal claims about why the patients died. In addition, cases identified in news media accounts do not provide a basis for establishing the relative risk of traveling abroad for care instead of seeking elective cosmetic surgery at domestic health care facilities. Acknowledging these limitations, the case reports suggest the possibility that contemporary peer-reviewed scholarship is underreporting patient mortality in medical travel. The paper makes a strong case for promoting normative analyses and empirical studies of medical travel. In particular, the paper argues that empirically informed ethical analysis of 'medical tourism' will benefit from rigorous studies tracking global flows of medical travelers and the clinical outcomes they experience. The paper contains practical recommendations intended to promote debate concerning how to promote patient safety and quality of care in medical travel. © 2012 Blackwell Publishing Ltd.

Communication with Orthopedic Trauma Patients via an Automated Mobile Phone Messaging Robot.

PubMed

Anthony, Chris A; Volkmar, Alexander; Shah, Apurva S; Willey, Mike; Karam, Matt; Marsh, J Lawrence

2017-12-20

Communication with orthopedic trauma patients is traditionally problematic with low response rates (RRs). The purpose of this investigation was to (1) evaluate the feasibility of communicating with orthopedic trauma patients postoperatively, utilizing an automated mobile phone messaging platform; and (2) assess the first 2 weeks of postoperative patient-reported pain and opioid use after lower extremity orthopedic trauma procedures. This was a prospective investigation at a Level 1 trauma center in the United States. Adult patients who were capable of mobile phone messaging and were undergoing common, lower extremity orthopedic trauma procedures were enrolled in the study. Patients received a daily mobile phone message protocol inquiring about their current pain level and amount of opioid medication they had taken in the past 24 h starting on postoperative day (POD) 3 and continuing through POD 17. Our analysis considered (1) Patient completion rate of mobile phone questions, (2) Patient-reported pain level (0-10 scale), and (3) Number and percentage of daily prescribed opioid medication patients reported taking. Twenty-five patients were enrolled in this investigation. Patients responded to 87.5% of the pain and opioid medication inquiries they received over the 2-week study period. There were no differences in RRs by patient age, sex, or educational attainment. Patient-reported pain decreased over the initial 2-week study period from an average of 4.9 ± 1.7 on POD 3 to 3 ± 2.2 on POD 16-17. Patients took an average of 68% of their maximum daily narcotic prescription on POD 3 compared with 35% of their prescribed pain medication on POD 16-17. We found that in orthopedic trauma patients, an automated mobile phone messaging platform elicited a high patient RR that improved upon prior methods in the literature. This method may be used to reliably obtain pain and medication utilization data after trauma procedures.

[Patient-reported and patient-weighted outcomes in ophthalmology].

PubMed

Scheibler, F; Finger, R P; Grosselfinger, R; Dintsios, C-M

2010-03-01

Considering patients' values and preferences in comparative effectiveness research (CER) is one of the main challenges in ophthalmology (value-based medicine). This article defines core terms in CER. The concept of patient-relevant (or patient-important) outcomes is distinguished from patient-reported outcomes (PRO) by means of examples in the field of ophthalmology. In order to be able to give a consistant recommendation if an intervention leads to conflicting results for different outcomes (trade-off), a ranking of outcomes will be necessary. Examples of studies in glaucoma patients are provided that demonstrate the possibilities of ranking of outcomes based on patient preferences.

Patient influences on satisfaction and loyalty for GP services.

PubMed

Rundle-Thiele, Sharyn; Russell-Bennett, Rebekah

2010-04-01

Little is known about the influence that patients themselves have on their loyalty to a general practitioner (GP). Consequently, a theoretical framework that draws on diverse literature is proposed to suggest that along with satisfaction, patient loyalty is an important outcome for GPs. Comprising 174 Australian patients, this study identified that knowledgeable patients reported lower levels of loyalty while older patients and patients visiting a GP more frequently reported higher levels of loyalty. The results suggest that extending patient-centered care practices to encompass all patients may be warranted in order to improve patient satisfaction and loyalty. Further, future research opportunities abound, with intervention and dyadic research methodologies recommended.

Retroperitoneoscopic lumbar sympathectomy for plantar hyperhidrosis.

PubMed

Lima, Sonia O; de Santana, Vanessa R; Valido, Daisy P; de Andrade, Renata L B; Fontes, Leticia M; Leite, Victor Hugo O; Neto, José M; Santos, Jéssica M; Varjão, Lucas L; Reis, Francisco P

2017-12-01

The objective of this study was to assess the reduction in quality of life (QoL) caused by the persistence of primary plantar hyperhidrosis (PPH) symptoms and the level of satisfaction in PPH patients after retroperitoneoscopic lumbar sympathectomy (RLS). The efficacy, safety, and procedure of bilateral RLS in both sexes are also described in this study. This is a longitudinal study of consecutive patients who sought specific treatment from a private practitioner for severe PPH as classified on the Hyperhidrosis Disease Severity Scale (HDSS) from October 2005 to October 2014. The patients were asked to report the symptoms of PPH experienced in the immediate preoperative period and to complete a standardized QoL questionnaire developed by de Campos at least 12 months after RLS. Disease outcomes, recurrence of symptoms, and any adverse effects of surgery were evaluated after 30 days and at least 12 months after RLS. Lumbar sympathectomy was performed 116 times in 58 patients; 30 days after surgery, PPH was resolved in all patients. Three patients (5.2%) reported transient thigh neuralgia, and 19 (32.7%) reported transient paresthesia in the lower limbs. There were no reports of retrograde ejaculation. At a minimum of 12 months after RLS, 49 of the 58 patients had fully and correctly answered the follow-up questionnaire and noted a mild (HDSS 2) to moderate (HDSS 3) increase in pre-existing compensatory sweating. One patient had a PPH relapse within 6 months. Improvement in QoL due to the resolution of PPH was reported in 98% of the 49 patients. None of the operations necessitated a change in the laparotomy approach, and none of the patients died. RLS is safe and effective for the treatment of severe PPH in both sexes. There were no reports of retrograde ejaculation after resection of L3 and L4 ganglia. There was a mild to moderate increase in compensatory sweating in about half of the patients, but without any regret or dissatisfaction for having undergone the surgery because of a significant improvement in QoL. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Behavioral measures and self-report of impulsivity in bipolar disorder: no association between Stroop test and Barratt Impulsiveness Scale.

PubMed

Strasser, Elisa Sophie; Haffner, Paula; Fiebig, Jana; Quinlivan, Esther; Adli, Mazda; Stamm, Thomas Josef

2016-12-01

Impulsivity as a tendency to act quickly without considering future consequences has been proposed as a dimensional factor in bipolar disorder. It can be measured using behavioral tasks and self-report questionnaires. Previous findings revealed patients to show worse performance on at least one behavioral measure of impulsivity. Additionally, self-reported impulsivity seems to be higher among bipolar patients, both parameters being possibly associated with a more severe course of illness. In this study, our primary aim was to investigate the relationship between these two constructs of impulsivity among bipolar patients. A total of 40 euthymic patients with bipolar disorder (21 female, 22 Bipolar I) and 30 healthy controls were recruited for comprehensive neuropsychological assessment. To assess inhibition control as a behavioral measure of impulsivity, the Stroop Color and Word Test (Stroop) was used. Additionally, both groups completed the Barratt Impulsiveness Scale (BIS) as a self-report of impulsivity. To compare the groups' performance on the Stroop and ratings on the BIS, the non-parametric Mann-Whitney U test was used. Within the bipolar group, we additionally examined the possibility of an association between Stroop performance and BIS total scores using Pearson's Correlation r. Patients and controls differed significantly on the Stroop and BIS, with patients performing worse on the Stroop and scoring higher on the BIS. However, there was no association between the Stroop and BIS within the bipolar group. As an exploratory analysis, a positive correlation between Stroop performance and number of episodes was found. Further, we detected a statistical trend in the direction of poorer Stroop performance among patients treated with polypharmacy. Both difficulties with behavioral inhibition and self-reported impulsivity were observed to be higher in bipolar patients than controls in the current study. However, within the patient group we did not observe an association between patients' behavioral performance and self-report. This indicates that the parameters likely constitute distinct, dimensional factors of bipolar disorder. In future research, studies with larger samples should investigate which of the two markers constitutes the better marker for the illness and is more suitable to differentiate the most severe patients.

Safety and effectiveness of daily teriparatide in a prospective observational study in patients with osteoporosis at high risk of fracture in Japan: final report

PubMed Central

Nishikawa, Atsushi; Ishida, Takehiro; Taketsuna, Masanori; Yoshiki, Fumito; Enomoto, Hiroyuki

2016-01-01

This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan. The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months. Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years. A total of 157 adverse drug reactions (ADRs) were reported in 140 (7.58%) patients; the most common ADRs were hyperuricemia, nausea, and dizziness. Only six (0.32%) patients reported serious ADRs, the most common being nausea (two patients; 0.1%). Persistence with teriparatide treatment was 60.8% and 39.1% at 18 and 24 months, respectively. There were significant increases in biomarkers for bone formation (procollagen type I N-terminal propeptide and bone-specific alkaline phosphatase) and bone resorption (collagen type I cross-linked C telopeptide and tartrate-resistant acid phosphatase 5b) throughout the study. These were accompanied by significant increases in bone mineral density and low incidences of new vertebral and nonvertebral fractures. Patient-reported measurements for health-related quality of life revealed significant improvements from baseline in back pain and overall health-related quality of life (Short Form-8™ health survey). The results of this 24-month postmarketing surveillance study imply that teriparatide has a favorable safety profile and is effective in the treatment of patients with osteoporosis at high risk of fracture in Japan. Teriparatide may also be a useful treatment for osteoporosis in other societies with aging populations. PMID:27462147

Pharmacists' interventions on clinical asthma outcomes: a systematic review.

PubMed

Garcia-Cardenas, Victoria; Armour, Carol; Benrimoj, Shalom I; Martinez-Martinez, Fernando; Rotta, Inajara; Fernandez-Llimos, Fernando

2016-04-01

The objective of this systematic review was to evaluate the impact of pharmacists' interventions on clinical asthma outcomes on adult patients and to identify the outcome indicators used.PubMed, Scopus, Web of Science and Scielo were searched. Studies addressing pharmacists' interventions on adult asthma patients reporting clinical asthma outcomes were incorporated.11 clinical outcomes were identified in 21 studies. 10 studies measured the impact of the intervention on asthma control. Randomised controlled trials (RCT) and non-RCTs found positive results in percentages of controlled patients and Asthma Control Questionnaire (ACQ) scores. Discordant results were found for Asthma Control Test results. Asthma severity was assessed in four studies. One RCT found a significant decrease in the percentage of severe patients; two non-RCTs found significant improvements in severity scores. 11 studies reported pulmonary function indicators, showing inconsistent results. Eight studies measured asthma symptoms; three RCTs and four non-RCTs showed significant improvements.RCTs and non-RCTs generated similar results for most outcomes. Based on the evidence generated by RCTs, pharmacists' have a positive impact on the percentage of controlled patients, ACQ scores, severity and symptoms. Future research should report using the core outcome set of indicators established for asthma (PROSPERO CRD42014007019). Copyright ©ERS 2016.

Long-term methylphenidate intake in chronic fatigue syndrome.

PubMed

Blockmans, Daniel; Persoons, Philippe

2016-12-01

Concentration disturbances are frequent in chronic fatigue syndrome (CFS). In a placebo-controlled double-blind crossover study, methylphenidate over 4 weeks was superior to placebo in the relief of fatigue and concentration disturbance. This observational study describes the effect of long-term methylphenidate intake on fatigue, concentration, and daily life activities, as reported by the patients themselves. A questionnaire was sent to all CFS patients who were prescribed methylphenidate at the general internal medicine department of a university hospital between August 2004 and February 2007, for possible improvement of concentration difficulties and fatigue. Out of 194 consecutive patients, 149 (76.8%) sent the questionnaire back. At the time of the questionnaire, 65.3% had stopped the intake of methylphenidate, 34.7% still took it daily or occasionally. Among the patients who continued methylphenidate, 48% reported an at least 50% improvement of fatigue, and 62% reported an at least 50% improvement of concentration difficulties. This continued intake of methylphenidate resulted in more working hours in these patients. Side effects (agitation, palpitations, and dry mouth) were reported significantly more in patients who had stopped methylphenidate than in those who still took it. The long-term intake of methylphenidate by CFS patients with concentration difficulties has a positive effect in about one out of three patients.

Validity of the Japanese Orthopaedic Association scoring system based on patient-reported improvement after posterior lumbar interbody fusion.

PubMed

Fujimori, Takahito; Okuda, Shinya; Iwasaki, Motoki; Yamasaki, Ryoji; Maeno, Takafumi; Yamashita, Tomoya; Matsumoto, Tomiya; Wada, Eiji; Oda, Takenori

2016-06-01

The Japanese Orthopaedic Association (JOA) scoring system is a physician-based outcome that has been used to evaluate treatment effectiveness after lumbar surgery. However, patient-centered evaluation becomes increasingly important. There is no study that has examined the relationship between the JOA scoring system and patients' self-reported improvement. The purpose of the present study was to validate the JOA scoring system for assessment of patient-reported improvement after lumbar surgery. This is a retrospective review of prospectively collected data. The patient sample included 273 mail-in responders of the 466 consecutive patients who underwent posterior lumbar interbody fusion for spondylolisthesis between 1996 and 2008 in a single hospital. The outcome measures were the JOA scoring system and patients' self-reported improvement. Two hundred seventy three patients were divided into five anchoring groups based on self-reported improvement from "Much better" to "Much worse." Outcomes (ie, recovery rate, amount of change from preoperative condition, and postoperative score) based on the JOA scoring system were compared among groups. Using the patient's self-reported improvement scale as an anchor, the association among each of the outcomes was examined. The cutoff point and the area under the curve (AUC) that differentiated "Improved" from "Neither improved nor worse" was calculated using receiver operating characteristic (ROC) curve analysis. The recovery rate and postoperative score were significantly different in 9 of 10 pairs of anchoring groups. The amount of change was significantly different in six pairs. Spearman correlation coefficient for the 5-point scale anchors of patients' self-reported improvement was 0.20 (p=.001) for the baseline score, 0.31 (p<.001) for the amount of change, 0.55 (p<.001) for the recovery rate, and 0.56 (p<.001) for the postoperative score. According to ROC analysis, the best cutoff points and AUCs were 13 points and 0.69, respectively, for the amount of change, 67% and 0.73, respectively, for recovery rate, and 23 points and 0.72, respectively, for postoperative score. The JOA scoring system is a valid method for assessment of patients' self-reported improvement. Patients' self-reported improvement is more likely to be associated with the final condition, such as postoperative score or recovery rate, rather than the change from the preoperative condition. Copyright © 2016 Elsevier Inc. All rights reserved.

Problems with health information technology and their effects on care delivery and patient outcomes: a systematic review.

PubMed

Kim, Mi Ok; Coiera, Enrico; Magrabi, Farah

2017-03-01

To systematically review studies reporting problems with information technology (IT) in health care and their effects on care delivery and patient outcomes. We searched bibliographic databases including Scopus, PubMed, and Science Citation Index Expanded from January 2004 to December 2015 for studies reporting problems with IT and their effects. A framework called the information value chain, which connects technology use to final outcome, was used to assess how IT problems affect user interaction, information receipt, decision-making, care processes, and patient outcomes. The review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Of the 34 studies identified, the majority ( n  = 14, 41%) were analyses of incidents reported from 6 countries. There were 7 descriptive studies, 9 ethnographic studies, and 4 case reports. The types of IT problems were similar to those described in earlier classifications of safety problems associated with health IT. The frequency, scale, and severity of IT problems were not adequately captured within these studies. Use errors and poor user interfaces interfered with the receipt of information and led to errors of commission when making decisions. Clinical errors involving medications were well characterized. Issues with system functionality, including poor user interfaces and fragmented displays, delayed care delivery. Issues with system access, system configuration, and software updates also delayed care. In 18 studies (53%), IT problems were linked to patient harm and death. Near-miss events were reported in 10 studies (29%). The research evidence describing problems with health IT remains largely qualitative, and many opportunities remain to systematically study and quantify risks and benefits with regard to patient safety. The information value chain, when used in conjunction with existing classifications for health IT safety problems, can enhance measurement and should facilitate identification of the most significant risks to patient safety. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Cell assisted lipotransfer in breast augmentation and reconstruction: A systematic review of safety, efficacy, use of patient reported outcomes and study quality.

PubMed

Arshad, Zeeshaan; Karmen, Lindsey; Choudhary, Rajan; Smith, James A; Branford, Olivier A; Brindley, David A; Pettitt, David; Davies, Benjamin M

2016-12-01

Cell assisted lipotransfer serves as a novel technique for both breast reconstruction and breast augmentation. This systematic review assesses the efficacy, safety and use of patient reported outcome measures in studies involving cell assisted lipotransfer. We also carry out an objective assessment of study quality focussing on recruitment, follow-up and provide an up-to-date clinical trial landscaping analysis. Key electronic databases were searched according to PRISMA guidelines and pre-defined inclusion and exclusion criteria. Two independent reviewers examined the retrieved publications and performed data extraction. 3980 publications were identified. Following screening, 11 studies were included for full review, representing a total of 336 patients with a follow-up time ranging from six to 42 months. A degree of variation was noted in graft retention and reported satisfaction levels, although there were only three comparative studies with conflicting results. Complications occurred at a rate of 37%. Additionally, there was a paucity of objective outcomes assessments (e.g. 3D assessment modalities or validated patient reported outcome measures) in the selected studies. Cell assisted lipotransfer is a surgical technique that is currently employed sparingly within the plastic & reconstructive surgery community. Presently, further technical and outcome standardization is required, in addition to rigorous randomized controlled trials and supporting long-term follow-up data to better determine procedural safety and efficacy. Routine use of more objective outcome measures, particularly 3D assessments and validated patient reported outcome measures, will also help facilitate wider clinical adoption and establish procedural utility.

Treatment adherence and perception in patients on maintenance hemodialysis: a cross - sectional study from Palestine.

PubMed

Naalweh, Karam Sh; Barakat, Mohammad A; Sweileh, Moutaz W; Al-Jabi, Samah W; Sweileh, Waleed M; Zyoud, Sa'ed H

2017-05-30

Adherence to diet recommendations, fluid restriction, prescribed medications, and attendance at hemodialysis (HD) sessions are essential for optimal and effective treatment of patients with end-stage renal disease. No data regarding this issue are available from Palestine. Therefore, this study was carried out to assess adherence to diet, fluid restriction, medications, and HD sessions. A cross-sectional study of HD patients at An-Najah National University Hospital was carried out during summer, 2016. Self-reported adherence behavior was obtained using a valid and reliable questionnaire (End-Stage Renal Disease Adherence Questionnaire: ESRD-AQ). Predialytic serum levels of potassium and phosphate were obtained as clinical indicator of diet and medication adherence respectively. In addition, interdialytic body weight (IDW) was also obtained from medical records and analyzed in relation to reported adherence of fluid restriction. A total of 220 patients answered all questions pertaining to ESRD-AQ. The mean age ± standard deviation of participants was 56.82 ± 14.51 years. Dietary adherence was observed in 24% while that of fluid restriction adherence was observed in 31% of studied patients. Reported adherence to HD sessions was 52% while that for medications was 81%. Overall, 122 (55.5%) patients had good adherence, 89 (40.5%) had moderate adherence, and 9 (4.1%) had poor adherence behavior. Male patients had significantly higher overall adherence scores than females (p = 0.034). A significant correlation between reported diet adherence and serum pre-HD potassium level (p < 0.01) was observed. A significant correlation between reported fluid restriction adherence and IDW (p < 0.01) was also found. However, no significant correlation between reported adherence and pre-HD phosphate level. There was significant correlation between overall perception and overall adherence score (p < 0.001). Counselling of patients regarding importance of adherence modalities was lowest for "staying for the entire dialysis time". Multivariate analysis indicated that elderly male patients who were city residents had higher odds of having higher adherence score. There was a good percentage of patients who had overall moderate or poor adherence. ESRD-AQ could be used to assess some aspects of HD adherence. Counselling and education of patients on HD are important to improve therapeutic outcome.

Seeing without Seeing? Degraded Conscious Vision in a Blindsight Patient.

PubMed

Overgaard, Morten; Fehl, Katrin; Mouridsen, Kim; Bergholt, Bo; Cleeremans, Axel

2008-08-21

Blindsight patients, whose primary visual cortex is lesioned, exhibit preserved ability to discriminate visual stimuli presented in their "blind" field, yet report no visual awareness hereof. Blindsight is generally studied in experimental investigations of single patients, as very few patients have been given this "diagnosis". In our single case study of patient GR, we ask whether blindsight is best described as unconscious vision, or rather as conscious, yet severely degraded vision. In experiment 1 and 2, we successfully replicate the typical findings of previous studies on blindsight. The third experiment, however, suggests that GR's ability to discriminate amongst visual stimuli does not reflect unconscious vision, but rather degraded, yet conscious vision. As our finding results from using a method for obtaining subjective reports that has not previously used in blindsight studies (but validated in studies of healthy subjects and other patients with brain injury), our results call for a reconsideration of blindsight, and, arguably also of many previous studies of unconscious perception in healthy subjects.

Long-term safety and efficacy of bilastine following up to 12 weeks or 52 weeks of treatment in Japanese patients with allergic rhinitis: Results of an open-label trial.

PubMed

Okubo, Kimihiro; Gotoh, Minoru; Togawa, Michinori; Saito, Akihiro; Ohashi, Yoshihiro

2017-06-01

Bilastine is a novel second-generation antihistamine. This open-label, single-arm, phase III study evaluated the safety and efficacy of long-term treatment with bilastine in Japanese patients with seasonal (SAR) or perennial allergic rhinitis (PAR). Patients with SAR or PAR who met the registration criteria and did not violate the exclusion criteria received bilastine (20mg, once daily) for 12 weeks (treatment period). Patients with PAR who met the transition criteria could elect to continue the bilastine treatment for an additional 40 weeks (continuous treatment period: a total of 52 weeks). Safety and tolerability were the primary outcomes, and the main secondary endpoint was to evaluate changes in efficacy variables from baseline measurements. Fifty-eight patients with SAR and 64 patients with PAR received bilastine (20mg/day) for 12 weeks. Fifty-five patients with PAR transitioned to the continuous treatment period. Adverse events (AEs) were reported by 17.2% of patients with SAR and by 31.3% of patients with PAR, and adverse drug reactions (ADRs) were reported by 6.3% of patients with PAR but by no patients with SAR during the 12-week treatment period. All of the ADRs were mild in severity. During the 52-week treatment period, AEs and ADRs were reported by 73.4% and 6.3% of patients with PAR, respectively. All of the ADRs occurred during the 12-week treatment period, and none during the continuous treatment period. The AEs were categorized using the System Organ Class of nervous system disorders; 4.7% of patients reported headache, but none reported somnolence. One serious AE was reported, but it was considered to be unrelated to the bilastine treatment. There were no deaths, and no patients withdrew from the study because of AEs. In patients with SAR, bilastine significantly decreased the total nasal symptom score (TNSS), total ocular symptom score (TOSS), and total symptom score (TSS) relative to baseline. Prolonged treatment with bilastine resulted in the maintenance of a significant reduction in TNSS, TOSS, and TSS from the baseline in patients with PAR. Improvement of quality of life was also observed in patients with SAR and PAR. Bilastine was safe, well tolerated, and effective for patients with SAR and PAR. The observed improvement was maintained for the duration of the study, with no loss of drug efficacy (registration number JapicCTI-142622). Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Cross-sectional study of anxiety symptoms and self-report of awake and sleep bruxism in female TMD patients.

PubMed

Tavares, Luisa Maria Faria; da Silva Parente Macedo, Leonora Cristina; Duarte, Cristina Maria Rabelais; de Goffredo Filho, Gilberto Senechal; de Souza Tesch, Ricardo

2016-11-01

The aim of this study was to assess the relationship between levels of anxiety symptoms and prevalence of self-report of awake and sleep bruxism in patients with temporomandibular disorders (TMD). One hundred and eighty-one female patients, aged 19-77 years, were consecutively evaluated. The patients were selected from among those who sought treatment at the TMD and Orofacial Pain Outpatient Clinic of the Petrópolis School of Medicine. All patients completed the questionnaire and underwent clinical examination, both components of the RDC/TMD, in addition to answering questions pertaining to the assessment of levels of anxiety symptoms, taken from the Symptom Check List 90 self-report instrument. The subjects were classified according to the presence of self-reported only awake bruxism, only sleep bruxism, both, or none. A logistic regression procedure was performed to evaluate the possible association through odds ratio between anxiety symptoms and self-reported awake or sleep bruxism. The cofactors for each outcome were age, self-reported bruxism during the circadian period other than the one being evaluated, and the use of selective serotonin reuptake inhibitors. It was possible to demonstrate the presence of a positive and statistically significant relationship between anxiety levels and self-reported awake bruxism. This finding was not observed in those subjects who reported sleep bruxism. A positive relationship was found between self-reported awake bruxism and levels of anxiety symptoms, but not between sleep bruxism and anxiety.

Panic symptoms in transient loss of consciousness: Frequency and diagnostic value in psychogenic nonepileptic seizures, epilepsy and syncope.

PubMed

Rawlings, G H; Jamnadas-Khoda, J; Broadhurst, M; Grünewald, R A; Howell, S J; Koepp, M; Parry, S W; Sisodiya, S M; Walker, M C; Reuber, M

2017-05-01

Previous studies suggest that ictal panic symptoms are common in patients with psychogenic nonepileptic seizures (PNES). This study investigates the frequency of panic symptoms in PNES and if panic symptoms, just before or during episodes, can help distinguish PNES from the other common causes of transient loss of consciousness (TLOC), syncope and epilepsy. Patients with secure diagnoses of PNES (n=98), epilepsy (n=95) and syncope (n=100) were identified using clinical databases from three United Kingdom hospitals. Patients self-reported the frequency with which they experienced seven symptoms of panic disorder in association with their episodes. A composite panic symptom score was calculated on the basis of the frequency of symptoms. 8.2% of patients with PNES reported "never" experiencing any of the seven panic symptoms in their episodes of TLOC. Patients with PNES reported more frequent panic symptoms in their attacks than those with epilepsy (p<0.001) or syncope (p<0.001), however, patients with PNES were more likely "rarely" or "never" to report five of the seven-ictal panic symptoms than "frequently" or "always" (45-69% versus 13-29%). A receiver operating characteristic analysis demonstrated that the composite panic symptom score distinguished patients with PNES from the other groups (sensitivity 71.1%, specificity 71.2%), but not epilepsy from syncope. Patients with PNES report TLOC associated panic symptoms more commonly than those with epilepsy or syncope. Although panic symptoms are reported infrequently by most patients with PNES, a composite symptom score may contribute to the differentiation between PNES and the other two common causes of TLOC. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Understanding Long-Term Outcomes and Patient Expectations Among Adolescents with Neonatal Brachial Plexus Palsy: A Qualitative and Quantitative Study

PubMed Central

Squitieri, Lee; Larson, Bradley P.; Chang, Kate W-C.; Yang, Lynda J-S.; Chung, Kevin C.

2014-01-01

Purpose Quality of life (QOL) among adolescents with neonatal brachial plexus palsy (NBPP) is an important but unexplored topic. To date, few NBPP studies use comprehensive patient-reported outcome measures, and none specifically address the adolescent population. This study explores the long-term QOL and patient expectations among adolescents with NBPP using qualitative and quantitative approaches. Methods Eighteen adolescents with residual NBPP impairment between the ages of 10 to 17 years along with their parents were included in our study. Adolescents and their parents underwent separate one hour tape-recorded semi-structured interviews, which were audio recorded and transcribed. We also collected quantitative patient outcome measures to quantify the degree of each adolescent’s functional impairment and to increase our understanding of long-term quality of life and patient expectations. Results Thirteen females and five males with a mean age of 11.6 years participated in our study. Through qualitative analysis we identified the following factors contributing to overall QOL from the patient and parent perspective: social impact and peer acceptance, emotional adjustment, aesthetic concerns and body image, functional limitations, physical and occupational therapy, finances, pain, and family dynamics. Despite residual impairment, most adolescents and their parents reported a good overall QOL according to quantitative outcome measures, with adolescents reporting slightly higher QOL than their parents. However, both adolescents and their parents report relatively modest satisfaction with their current condition and express expectations for improvement in multiple areas. Discussion Understanding patient expectations and QOL in NBPP adolescents are essential for medical decision-making and advancing care. Our study results showed that functional and aesthetic factors were responsible for the majority of observed differences in QOL among NBPP adolescents. We also found that the PODCI might be more sensitive than the CHQ in assessing patient expectations and quality of life among this patient population. PMID:24416766

Long-term safety profile of anakinra in patients with severe cryopyrin-associated periodic syndromes.

PubMed

Kullenberg, Torbjörn; Löfqvist, Malin; Leinonen, Mika; Goldbach-Mansky, Raphaela; Olivecrona, Hans

2016-08-01

Anakinra is approved for the treatment of RA and cryopyrin-associated periodic syndromes (CAPS). While the anakinra safety profile is well established in RA, the long-term safety profile in severe CAPS is less well documented and will therefore be discussed in this report. A prospective, open-label, single centre, clinical cohort study was conducted at the National Institutes of Health in the USA, from 2003 to 2010, investigating the efficacy and safety of anakinra treatment for up to 5 years in 43 patients with CAPS. Safety was evaluated using adverse event (AE) reports, laboratory assessments, vital signs and diary reports. In total, 1233 AEs were reported during the study, with a yearly rate of 7.7 AEs per patient. The event rate decreased over time, and dose escalation during the study did not affect AE frequency. Anakinra had similar safety profiles in adults and children. The most frequently reported AEs were typical CAPS disease symptoms such as headache and arthralgia. Injection site reactions occurred mainly during the first month of anakinra treatment. In total, 14 patients experienced 24 serious AEs (SAEs), all of which resolved during the study period. The most common types of SAEs were infections such as pneumonia and gastroenteritis. There were no permanent discontinuations of treatment due to AEs. In this study anakinra treatment of patients with severe CAPS for up to 5 years was safe and well tolerated both in paediatric and adult patients, with most AEs emerging during the first months after treatment initiation. ClincialTrials.gov, clinicaltrials.gov, NCT00069329. © The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology.

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

PubMed Central

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

2015-01-01

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

Families as Partners in Hospital Error and Adverse Event Surveillance

PubMed Central

Khan, Alisa; Coffey, Maitreya; Litterer, Katherine P.; Baird, Jennifer D.; Furtak, Stephannie L.; Garcia, Briana M.; Ashland, Michele A.; Calaman, Sharon; Kuzma, Nicholas C.; O’Toole, Jennifer K.; Patel, Aarti; Rosenbluth, Glenn; Destino, Lauren A.; Everhart, Jennifer L.; Good, Brian P.; Hepps, Jennifer H.; Dalal, Anuj K.; Lipsitz, Stuart R.; Yoon, Catherine S.; Zigmont, Katherine R.; Srivastava, Rajendu; Starmer, Amy J.; Sectish, Theodore C.; Spector, Nancy D.; West, Daniel C.; Landrigan, Christopher P.

2017-01-01

IMPORTANCE Medical errors and adverse events (AEs) are common among hospitalized children. While clinician reports are the foundation of operational hospital safety surveillance and a key component of multifaceted research surveillance, patient and family reports are not routinely gathered. We hypothesized that a novel family-reporting mechanism would improve incident detection. OBJECTIVE To compare error and AE rates (1) gathered systematically with vs without family reporting, (2) reported by families vs clinicians, and (3) reported by families vs hospital incident reports. DESIGN, SETTING, AND PARTICIPANTS We conducted a prospective cohort study including the parents/caregivers of 989 hospitalized patients 17 years and younger (total 3902 patient-days) and their clinicians from December 2014 to July 2015 in 4 US pediatric centers. Clinician abstractors identified potential errors and AEs by reviewing medical records, hospital incident reports, and clinician reports as well as weekly and discharge Family Safety Interviews (FSIs). Two physicians reviewed and independently categorized all incidents, rating severity and preventability (agreement, 68%–90%; κ, 0.50–0.68). Discordant categorizations were reconciled. Rates were generated using Poisson regression estimated via generalized estimating equations to account for repeated measures on the same patient. MAIN OUTCOMES AND MEASURES Error and AE rates. RESULTS Overall, 746 parents/caregivers consented for the study. Of these, 717 completed FSIs. Their median (interquartile range) age was 32.5 (26–40) years; 380 (53.0%) were nonwhite, 566 (78.9%) were female, 603 (84.1%) were English speaking, and 380 (53.0%) had attended college. Of 717 parents/caregivers completing FSIs, 185 (25.8%) reported a total of 255 incidents, which were classified as 132 safety concerns (51.8%), 102 nonsafety-related quality concerns (40.0%), and 21 other concerns (8.2%). These included 22 preventable AEs (8.6%), 17 nonharmful medical errors (6.7%), and 11 nonpreventable AEs (4.3%) on the study unit. In total, 179 errors and 113 AEs were identified from all sources. Family reports included 8 otherwise unidentified AEs, including 7 preventable AEs. Error rates with family reporting (45.9 per 1000 patient-days) were 1.2-fold (95%CI, 1.1–1.2) higher than rates without family reporting (39.7 per 1000 patient-days). Adverse event rates with family reporting (28.7 per 1000 patient-days) were 1.1-fold (95%CI, 1.0–1.2; P=.006) higher than rates without (26.1 per 1000 patient-days). Families and clinicians reported similar rates of errors (10.0 vs 12.8 per 1000 patient-days; relative rate, 0.8; 95%CI, .5–1.2) and AEs (8.5 vs 6.2 per 1000 patient-days; relative rate, 1.4; 95%CI, 0.8–2.2). Family-reported error rates were 5.0-fold (95%CI, 1.9–13.0) higher and AE rates 2.9-fold (95% CI, 1.2–6.7) higher than hospital incident report rates. CONCLUSIONS AND RELEVANCE Families provide unique information about hospital safety and should be included in hospital safety surveillance in order to facilitate better design and assessment of interventions to improve safety. PMID:28241211

An evaluation of the use of massage and essential oils on the wellbeing of cancer patients.

PubMed

Corner, Jessica; Cawley, Nik; Hildebrand, Sheena

1995-04-02

Massage and aromatherapy are being used increasingly by nurses to enhance the wellbeing of patients in palliative care settings, yet little evaluation of these therapies has been undertaken. This article reports a quasi experimental study comparing the effects of an 8-week course of massage, with or without the addition of a blend of essential oils, on patients undergoing cancer treatment. Findings from the study suggest that massage has a significant effect on anxiety and this was found to be greater where essential oils were used, although the small sample prevented this from being established conclusively. Massage was reported to be universally beneficial by patients, it assisted relaxation and reduced physical and emotional symptoms. The authors call for more research to be conducted in this area with larger cohorts of patients. Copies of the full research report for this study may be obtained from the Macmillan Practice Development Unit, Centre for Cancer and Palliative Care Studies, Institute of Cancer Research/Royal Marsden NHS Trust, Fulham Road, London SW3 6JJ. Price £6.00.

Detection of medical errors in kidney transplantation: a pilot study comparing proactive clinician debriefings to a hospital-wide incident reporting system.

PubMed

McElroy, Lisa M; Daud, Amna; Lapin, Brittany; Ross, Olivia; Woods, Donna M; Skaro, Anton I; Holl, Jane L; Ladner, Daniela P

2014-11-01

Rates of medical errors and adverse events remain high for patients who undergo kidney transplantation; they are particularly vulnerable because of the complexity of their disease and the kidney transplantation procedure. Although institutional incident-reporting systems are used in hospitals around the country, they often fail to capture a substantial proportion of medical errors. The goal of this study was to assess the ability of a proactive, web-based clinician safety debriefing to augment the information about medical errors and adverse events obtained via traditional incident reporting systems. Debriefings were sent to all individuals listed on operating room personnel reports for kidney transplantation surgeries between April 2010 and April 2011, and incident reports were collected for the same time period. The World Health Organization International Classification for Patient Safety was used to classify all issues reported. A total of 270 debriefings reported 334 patient safety issues (179 safety incidents, 155 contributing factors), and 57 incident reports reported 92 patient safety issues (56 safety incidents, 36 contributing factors). Compared with incident reports, more attending physicians completed the debriefings (32.0 vs 3.5%). The use of a proactive, web-based debriefing to augment an incident reporting system in assessing safety risks in kidney transplantation demonstrated increased information, more perspectives of a single safety issue, and increased breadth of participants. Copyright © 2014 Elsevier Inc. All rights reserved.

A cross-sectional mixed methods study protocol to generate learning from patient safety incidents reported from general practice.

PubMed

Carson-Stevens, Andrew; Hibbert, Peter; Avery, Anthony; Butlin, Amy; Carter, Ben; Cooper, Alison; Evans, Huw Prosser; Gibson, Russell; Luff, Donna; Makeham, Meredith; McEnhill, Paul; Panesar, Sukhmeet S; Parry, Gareth; Rees, Philippa; Shiels, Emma; Sheikh, Aziz; Ward, Hope Olivia; Williams, Huw; Wood, Fiona; Donaldson, Liam; Edwards, Adrian

2015-12-01

Incident reports contain descriptions of errors and harms that occurred during clinical care delivery. Few observational studies have characterised incidents from general practice, and none of these have been from the England and Wales National Reporting and Learning System. This study aims to describe incidents reported from a general practice care setting. A general practice patient safety incident classification will be developed to characterise patient safety incidents. A weighted-random sample of 12,500 incidents describing no harm, low harm and moderate harm of patients, and all incidents describing severe harm and death of patients will be classified. Insights from exploratory descriptive statistics and thematic analysis will be combined to identify priority areas for future interventions. The need for ethical approval was waivered by the Aneurin Bevan University Health Board research risk review committee given the anonymised nature of data (ABHB R&D Ref number: SA/410/13). The authors will submit the results of the study to relevant journals and undertake national and international oral presentations to researchers, clinicians and policymakers. 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/

Exacerbation of Behçet's syndrome and familial Mediterranean fever with menstruation.

PubMed

Guzelant, Gul; Ozguler, Yesim; Esatoglu, Sinem Nihal; Karatemiz, Guzin; Ozdogan, Huri; Yurdakul, Sebahattin; Yazici, Hasan; Seyahi, Emire

2017-01-01

Menstruation triggers several conditions such as migraine, recurrent aphthous stomatitis and acne vulgaris in healthy individuals. There is evidence that Behçet's syndrome (BS) and familial Mediterranean fever (FMF) may exacerbate during menstruation. The aim is to assess whether BS and FMF patients experience menstrual flares. Females of reproductive age with BS and FMF seen consecutively at the outpatient clinic of Cerrahpasa Medical Faculty at Istanbul, as well as apparently healthy hospital workers were studied using a standardised questionnaire. BS patients were asked whether they experienced increased skin-mucosa lesions during the menstrual period. A similar questionnaire assessing this time the frequency of abdominal pain, chest pain and fever attacks was given to the patients with FMF. The healthy controls received both questionnaires. A total of 200 BS patients, 240 FMF patients and 250 healthy controls were studied. The most commonly reported symptom among both BS patients (51%) and healthy controls (62%) was the acneiform lesion. At least 79% patients with FMF reported attacks with menstruation, notably abdominal pain which, majority thought, could be differentiated from dysmenorrhea. Additionally, 76% of healthy controls reported having abdominal pain consistent most probably with dysmenorrhea. This survey showed that, in 68% of the patients with BS at least one skin mucosa lesion was exacerbated with menstruation, this was most commonly acneiform lesion. Menstruation had a slightly stronger effect on FMF, triggering at least one symptom in 79%. The main limitation of the study was the self-reported assessment methodology.

Efficacy of moclobemide in burning mouth syndrome: a nonrandomized, open-label study.

PubMed

Pekiner, Filiz Namdar; Gumru, Birsay; Ozbayrak, Semih

2008-01-01

To compare burning mouth syndrome (BMS) patients with age- and gender-matched controls for psychologic conditions, to analyze the effect of menstrual state on the intensity of burning, and to assess the efficacy of an antidepressant medication on the burning pain and psychologic status. Ninety-four patients with BMS and 94 matched control subjects participated in the study. Anxiety and depression were analyzed by means of the Spielberger State-Trait Anxiety Inventory and Zung Self-Rating Depression Scale, and the severity of the burning sensation was measured by means of a visual analog scale (VAS). In female BMS patients and controls, the menstrual state was noted (menstruating, menopausal, or postmenopausal). BMS patients were treated with the antidepressant moclobemide (150 mg 2 times daily) for 3 months. Thereafter, anxiety, depression, and burning pain intensity were reassessed. Patient-perceived satisfactory improvement for burning sensation was assessed using a 5-point categorical rating of change scale. BMS patients had significantly higher anxiety and depression scores than controls (P < .05). After treatment, anxiety and depression scores as well as the VAS values for burning pain decreased significantly (P < .001). Thirty-seven patients reported good to very good improvement, and 44 reported satisfactory improvement. No adverse reactions were reported. The study confirmed earlier reports that BMS patients have higher anxiety and depression levels than controls. An antidepressant medication may be effective in alleviating the burning pain, at least in the short-term.

Analgesic effectiveness of D-phenylalanine in chronic pain patients.

PubMed

Walsh, N E; Ramamurthy, S; Schoenfeld, L; Hoffman, J

1986-07-01

Enkephalins are a biochemical pathway for endogenous analgesia. A number of compounds inhibit degradation of enkephalins within the body. One of these compounds, D-phenylalanine (DPA), has been shown to increase the pain threshold in animals. It is hypothesized that this naloxone reversible analgesia is induced by DPA blockage of enkephalin degradation by the enzyme carboxypeptidase A. Preliminary studies of chronic pain patients have shown a response rate to DPA from 32% to 75%. This study was a double-blind crossover evaluation of a randomized parallel design to determine the efficacy of DPA in 30 subjects with chronic pain from varied etiology which was unrelieved by multiple therapeutic interventions. Each patient received a stabilized therapeutic regimen during this study consisting of four weeks of either DPA 250 mg or lactose (placebo) orally four times a day. After four weeks the DPA and placebo groups were crossed over for an additional four weeks of treatment. Pain was quantified using a visual analog pain scale and a cold pressor test. Data from the pain questionnaires revealed more pain relief on DPA reported by 25% of the patients, more pain relief on placebo reported by 22% of the patients, and no difference in pain relief reported by 53% of the patients. Lowest pain level of the visual analog scale was reported by 47% of the patients on DPA and 53% on placebo. There appears to be no significant analgesic effect from D-phenylalanine in chronic pain patients when compared to placebo.

Daily collection of self-reporting sleep disturbance data via a smartphone app in breast cancer patients receiving chemotherapy: a feasibility study.

PubMed

Min, Yul Ha; Lee, Jong Won; Shin, Yong-Wook; Jo, Min-Woo; Sohn, Guiyun; Lee, Jae-Ho; Lee, Guna; Jung, Kyung Hae; Sung, Joohon; Ko, Beom Seok; Yu, Jong-Han; Kim, Hee Jeong; Son, Byung Ho; Ahn, Sei Hyun

2014-05-23

Improvements in mobile telecommunication technologies have enabled clinicians to collect patient-reported outcome (PRO) data more frequently, but there is as yet limited evidence regarding the frequency with which PRO data can be collected via smartphone applications (apps) in breast cancer patients receiving chemotherapy. The primary objective of this study was to determine the feasibility of an app for sleep disturbance-related data collection from breast cancer patients receiving chemotherapy. A secondary objective was to identify the variables associated with better compliance in order to identify the optimal subgroups to include in future studies of smartphone-based interventions. Between March 2013 and July 2013, patients who planned to receive neoadjuvant chemotherapy for breast cancer at Asan Medical Center who had access to a smartphone app were enrolled just before the start of their chemotherapy and asked to self-report their sleep patterns, anxiety severity, and mood status via a smartphone app on a daily basis during the 90-day study period. Push notifications were sent to participants daily at 9 am and 7 pm. Data regarding the patients' demographics, interval from enrollment to first self-report, baseline Beck's Depression Inventory (BDI) score, and health-related quality of life score (as assessed using the EuroQol Five Dimensional [EQ5D-3L] questionnaire) were collected to ascertain the factors associated with compliance with the self-reporting process. A total of 30 participants (mean age 45 years, SD 6; range 35-65 years) were analyzed in this study. In total, 2700 daily push notifications were sent to these 30 participants over the 90-day study period via their smartphones, resulting in the collection of 1215 self-reporting sleep-disturbance data items (overall compliance rate=45.0%, 1215/2700). The median value of individual patient-level reporting rates was 41.1% (range 6.7-95.6%). The longitudinal day-level compliance curve fell to 50.0% at day 34 and reached a nadir of 13.3% at day 90. The cumulative longitudinal compliance curve exhibited a steady decrease by about 50% at day 70 and continued to fall to 45% on day 90. Women without any form of employment exhibited the higher compliance rate. There was no association between any of the other patient characteristics (ie, demographics, and BDI and EQ5D-3L scores) and compliance. The mean individual patient-level reporting rate was higher for the subgroup with a 1-day lag time, defined as starting to self-report on the day immediately after enrollment, than for those with a lag of 2 or more days (51.6%, SD 24.0 and 29.6%, SD 25.3, respectively; P=.03). The 90-day longitudinal collection of daily self-reporting sleep-disturbance data via a smartphone app was found to be feasible. Further research should focus on how to sustain compliance with this self-reporting for a longer time and select subpopulations with higher rates of compliance for mobile health care.

Out of sight, but not out of mind? Greater reported pain in patients who spontaneously look away during venepuncture.

PubMed

Vijayan, R; Scott, G; Brownlie, W

2015-01-01

Various external factors can influence patients' experiences of noxious stimuli, but little is known of how patients' natural behaviour may be relevant. We ascertained how often patients spontaneously look or look away during venepuncture and associated reports of pain during a previously reported experimental randomized study. The study was conducted in the outpatient department of a U.K. district general hospital. Patients were randomized to hearing 'sharp scratch' or the verbal cue 'ready?' immediately before venepuncture. Whether patients looked or looked away during needle insertion was recorded. Patients were asked to rate their pain using a verbal numerical rating score (VNRS) and verbal response scale (VRS). One hundred ninety-two patients were included; mean age 51.7 years, 55% male. During needle insertion, 73% spontaneously looked away, whereas 27% looked. There was no significant difference in the proportion of these patients assigned to the 'sharp scratch' or 'ready?' groups, nor was there any difference in mean age or gender. For the group that looked, mean VNRS was 0.48 and VRS was 1.27, significantly less than the group that looked away (mean VNRS 0.94, p = 0.014; VRS 1.61, p = 0.002). As previously reported, pain ratings between 'sharp scratch' and 'ready?' groups were not significantly different. Almost three quarters of patients spontaneously look away during venepuncture, but their pain ratings are almost twice that of the quarter of patients who look. It is unclear why this may be, but previous experimental studies indicate that observing the body when a noxious stimulus is applied can have an analgesic effect. © 2014 European Pain Federation - EFIC®

Adverse drug reactions associated with the use of disease-modifying anti-rheumatic drugs in patients with rheumatoid arthritis.

PubMed

Machado-Alba, Jorge Enrique; Ruiz, Andrés Felipe; Machado-Duque, Manuel Enrique

2014-12-01

This study describes the adverse drug reactions (ADRs) and their incidence in patients with rheumatoid arthritis who were treated in the Colombian health system. A retrospective cohort study was conducted using information from all patients who were diagnosed with rheumatoid arthritis and attended specialized health care centers in the cities of Bogotá, Cali, Manizales, Medellin, and Pereira between 1 December 2009 and 30 August 2013. The ADRs were obtained from medical records and the pharmacovigilance system registry and sorted by frequency and affected tissue according to World Health Organization Adverse Reaction Terminology (WHO-ART). A total of 949 reports of ADRs were obtained from 419 patients (32.8 ADRs per 100 patient-years); these patients were from a cohort of 1,364 patients being treated for rheumatoid arthritis and followed up for an average of 23.8 months (± 12.9). The cohort was mostly female (366, 87.4%) and had a mean age of 52.7 years (± 13.1). The highest numbers of ADRs were reported following the use of tocilizumab, rituximab, and infliximab (28.8, 23.1, and 13.3 reports per 100 patient-years respectively). The most frequently reported ADRs were elevated transaminase levels and dyspepsia. Overall, 87.7% of ADRs were classified as type A, 36.6% as mild, 40.7% as moderate, and 22.7% as severe. As a result, 73.2% of patients who experienced an ADR stopped taking their drugs. The occurrence of ADRs in patients treated for rheumatoid arthritis is common, especially in those associated with the use of biotechnologically produced anti-rheumatic drugs. This outcome should be studied in future research and monitoring is needed to reduce the risks in these patients.

Resurfacing shoulder arthroplasty for the treatment of severe rheumatoid arthritis: outcome in 167 patients from the Danish Shoulder Registry.

PubMed

Voorde, Pia C Ten; Rasmussen, Jeppe V; Olsen, Bo S; Brorson, Stig

2015-06-01

There is no consensus on which type of shoulder prosthesis should be used in patients with rheumatoid arthritis (RA). We describe patients with RA who were treated with shoulder replacement, regarding patient-reported outcome, prosthesis survival, and causes of revision, and we compare outcome after resurfacing hemi-arthroplasty (RHA) and stemmed hemi-arthroplasty (SHA). We used data from the national Danish Shoulder Arthroplasty Registry and included patients with RA who underwent shoulder arthroplasty in Denmark between 2006 and 2010. Patient-reported outcome was obtained 1-year postoperatively using the Western Ontario Osteoarthritis of the Shoulder index (WOOS), and rates of revision were calculated by checking revisions reported until December 2011. The patient-reported outcome of RHA was compared to that of SHA using regression analysis with adjustment for age, sex, and previous surgery. During the study period, 167 patients underwent shoulder arthroplasty because of rheumatoid arthritis, 80 (48%) of whom received RHA and 34 (26%) of whom received SHA. 16 patients were treated with total stemmed shoulder arthroplasty (TSA), and 24 were treated with reverse shoulder arthroplasty (rTSA). 130 patients returned a completed questionnaire, and the total mean WOOS score was 63. The cumulative 5-year revision rate was 7%. Most revisions occurred after RHA, with a revision rate of 14%. Mean WOOS score was similar for RHA and for SHA. This study shows that shoulder arthroplasty, regardless of design, is a good option in terms of reducing pain and improving function in RA patients. The high revision rate in the RHA group suggests that other designs may offer better implant survival. However, this should be confirmed in larger studies.

Satisfaction with tolterodine: assessing symptom-specific patient-reported goal achievement in the treatment of overactive bladder in female patients (STARGATE study).

PubMed

Choo, M-S; Doo, C K; Lee, K-S

2008-02-01

Open-label study to evaluate the effect of tolterodine extended-release (ER) on symptom-specific patient-reported goal achievement (PGA) of overactive bladder (OAB) symptoms in females. Eligible patients who had frequency >or= 8 and urgency >or= 2 episodes per 24 h with or without urgency incontinence were treated with 12-week tolterodine ER (4 mg once daily). Primary end-point was the rate of PGA by a visual analogue scale compared with initial expectation with treatment. At baseline, patients were asked to set their personal goals for each OAB symptom with treatment. Secondary efficacy variables were changes in symptom severity, voiding diary and patient perception of bladder condition (PPBC), global impression of improvement (GII), and willingness to continue treatment. A total of 56 patients were entered. The median rate of symptom-specific PGA and reductions in symptom severity were for frequency (60%, 45%), episodes of urgency 60%, 55%), urge incontinence (80%, 71%), nocturia (50%, 52%) and tenesmus (30%, 26%) after 12 weeks treatment. There was a significant improvement in all OAB symptoms in voiding diary. Thirty-five patients (62.5%) experienced an improvement of >or= 2 points in PPBC. Thirty (53.6%) and 22 (39.3%) of patients reported much and little improvement of their symptoms in GII. A total of 41 (73.2%) patients wanted to continue taking the medication at the end of the study. Most OAB patients reported improvement of their OAB symptoms with 12-week tolterodine ER 4 mg treatment. There was a significant achievement of symptom-specific goal on the key OAB symptoms. But, PGA did not correlate with objective outcomes.

Integrating Electronic Patient-Reported Outcome Measures into Routine HIV Care and the ANRS CO3 Aquitaine Cohort's Data Capture and Visualization System (QuAliV): Protocol for a Formative Research Study.

PubMed

Barger, Diana; Leleux, Olivier; Conte, Valérie; Sapparrart, Vincent; Gapillout, Marie; Crespel, Isabelle; Erramouspe, Marie; Delveaux, Sandrine; Dabis, Francois; Bonnet, Fabrice

2018-06-07

Effective antiretroviral therapy has greatly reduced HIV-related morbidity and mortality, dramatically changing the demographics of the population of people living with HIV. The majority of people living with HIV in France are well cared for insofar as their HIV infection is concerned but remain at risk for age-associated comorbidities. Their long-term, potentially complex, and growing care needs make the routine, longitudinal assessment of health-related quality of life and other patient-reported outcomes of relevance in the current treatment era. We aim to describe the development of a Web-based electronic patient-reported outcomes system for people living with HIV linked to the ANRS CO3 Aquitaine cohort's data capture and visualization system (ARPEGE) and designed to facilitate the electronic collection of patient-reported data and ultimately promote better patient-physician communication and quality of care (both patient satisfaction and health outcomes). Participants who meet the eligibility criteria will be invited to engage with the Web-based electronic patient-reported outcomes system and provided with the information necessary to create a personal patient account. They will then be able to access the electronic patient-reported outcomes system and complete a set of standardized validated questionnaires covering health-related quality of life (World Health Organization's Quality of Life Instrument in HIV infection, named WHOQOL-HIV BREF) and other patient-reported outcomes. The information provided via questionnaires will ultimately be presented in a summary format for clinicians, together with the patient's HIV care history. The prototype of the Web-based electronic patient-reported outcome system will be finalized and the first 2 formative research phases of the study (prototyping and usability testing) will be conducted from December 2017 to May 2018. We describe the sequential processes planned to ensure that the proposed electronic patient-reported outcome system is ready for formal pilot testing, referred to herein as phases 1a and 1b. We also describe the planned pilot-testing designed to evaluate the acceptability and use of the system from the patient's perspective (phase 2). As the underlying information technology solution, ARPEGE, has being developed in-house, should the feasibility study presented here yield promising results, the panel of services provided via the proposed portal could ultimately be expanded and used to experiment with health-promoting interventions in aging people living with HIV in hospital-based care or adapted for use in other patient populations. ClinicalTrials.gov NCT03296202; https://clinicaltrials.gov/ct2/show/NCT03296202 (Archived by WebCite at http://www.webcitation.org/6zgOBArps). RR1-10.2196/9439. ©Diana Barger, Olivier Leleux, Valérie Conte, Vincent Sapparrart, Marie Gapillout, Isabelle Crespel, Marie Erramouspe, Sandrine Delveaux, Francois Dabis, Fabrice Bonnet. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.06.2018.

Permanent catheters for recurrent ascites-a critical and systematic review of study methodology.

PubMed

Christensen, Lars; Wildgaard, Lorna; Wildgaard, Kim

2016-06-01

Management of refractory ascites traditionally includes medical treatment with diuretics or intermittent paracentesis. Patients with recurrent ascites may benefit from the use of permanent intra-abdominal catheters with more frequent drainage without hospitalization. The objective was to systematically asses the methodology of factors and endpoints reported in studies investigating permanent catheters for recurrent ascites treatment. Using a systematic search strategy, we critically assessed the methodology when treating refractory ascites using a permanent catheter. Studies critically assessed included both retro- and prospective studies. A total of 715 unique articles were found via PubMed, The Cochrane Library and Embase. Twenty-nine studies (tunnelled catheter = 12, peritoneal ports = 6 and peritoneovenous shunts = 11) with three distinct types of permanent catheters fulfilled the inclusion criteria. Only three studies reported technical success less than 100 %. Data on complications and treatment were not available in all papers; peritonitis (48 %), cellulitis (41 %), prophylactic antibiotics (48 %) and complications to catheter insertion were difficult to distinguish from advanced co-morbidity of patients. Thirteen studies (45 %) reported some type of evaluating patient experience or functional outcome, but only three studies used validated reproducible scales when assessing outcomes. Fifteen of the 29 studies included 30 patients or less. Knowledge is limited because complications and outcomes are poorly defined. The expected increase in catheter treatment of refractory ascites necessitates comparative studies, using validated patient-related outcomes, and the reporting of unambiguous complications. A proposal of variables to include in future studies is presented.

Navigation-assisted versus conventional total knee replacement: no difference in patient-reported outcome measures (PROMs) at 1 and 2 years.

PubMed

Singisetti, Kiran; Muthumayandi, Karthikeyan; Abual-Rub, Zaid; Weir, David

2015-11-01

Navigation technique for total knee replacement has been shown to improve accuracy of prosthesis alignment in several studies. The purpose was to compare the patient-reported outcome measures in primary total knee replacement (TKR) using navigation versus conventional surgical technique at 1- and 2-year follow-up. A retrospective review of prospectively collected patient-reported outcome data for 351 consecutively performed primary TKR was included in the study. The study group (N = 113) included patients who had Triathlon TKR using articular surface mounted (ASM Stryker) navigation technique and control group (N = 238) included patients who had Triathlon TKR using conventional jig. In addition to the WOMAC (Western Ontario and McMaster University Osteoarthritis Index) and SF-36 (Medical Outcomes Trust Short Form-36), a short self-report questionnaire evaluating the level of satisfaction, quality of life and whether patients would undergo knee replacement again. WOMAC: no significant difference between the groups was noted in mean WOMAC pain, function and stiffness scores at 1- and 2-year follow-up. SF-36: no significant difference between the groups was seen except in the physical function component of score at 1 year (p = 0.019). Navigation group mean 56.78 (CI 51.06-62.5) versus conventional group mean 48.34 (44.68-52.01) but this difference was not observed at 2-year follow-up. The overall patient-reported outcome scores improved after total knee replacement but appear to be comparable in both groups at 1- and 2-year follow-up.

Patient safety climate (PSC) perceptions of frontline staff in acute care hospitals: examining the role of ease of reporting, unit norms of openness, and participative leadership.

PubMed

Zaheer, Shahram; Ginsburg, Liane; Chuang, You-Ta; Grace, Sherry L

2015-01-01

Increased awareness regarding the importance of patient safety issues has led to the proliferation of theoretical conceptualizations, frameworks, and articles that apply safety experiences from high-reliability industries to medical settings. However, empirical research on patient safety and patient safety climate in medical settings still lags far behind the theoretical literature on these topics. The broader organizational literature suggests that ease of reporting, unit norms of openness, and participative leadership might be important variables for improving patient safety. The aim of this empirical study is to examine in detail how these three variables influence frontline staff perceptions of patient safety climate within health care organizations. A cross-sectional study design was used. Data were collected using a questionnaire composed of previously validated scales. The results of the study show that ease of reporting, unit norms of openness, and participative leadership are positively related to staff perceptions of patient safety climate. Health care management needs to involve frontline staff during the development and implementation stages of an error reporting system to ensure staff perceive error reporting to be easy and efficient. Senior and supervisory leaders at health care organizations must be provided with learning opportunities to improve their participative leadership skills so they can better integrate frontline staff ideas and concerns while making safety-related decisions. Finally, health care management must ensure that frontline staff are able to freely communicate safety concerns without fear of being punished or ridiculed by others.

Brain pathology after mild traumatic brain injury: an exploratory study by repeated magnetic resonance examination.

PubMed

Lannsjö, Marianne; Raininko, Raili; Bustamante, Mariana; von Seth, Charlotta; Borg, Jörgen

2013-09-01

To explore brain pathology after mild traumatic brain injury by repeated magnetic resonance examination. A prospective follow-up study. Nineteen patients with mild traumatic brain injury presenting with Glasgow Coma Scale (GCS) 14-15. The patients were examined on day 2 or 3 and 3-7 months after the injury. The magnetic resonance protocol comprised conventional T1- and T2-weighted sequences including fluid attenuated inversion recovery (FLAIR), two susceptibility-weighted sequences to reveal haemorrhages, and diffusion-weighted sequences. Computer-aided volume comparison was performed. Clinical outcome was assessed by the Rivermead Post-Concussion Symptoms Questionnaire (RPQ), Hospital Anxiety and Depression Scale (HADS) and Glasgow Outcome Scale Extended (GOSE). At follow-up, 7 patients (37%) reported ≥  3 symptoms in RPQ, 5 reported some anxiety and 1 reported mild depression. Fifteen patients reported upper level of good recovery and 4 patients lower level of good recovery (GOSE 8 and 7, respectively). Magnetic resonance pathology was found in 1 patient at the first examination, but 4 patients (21%) showed volume loss at the second examination, at which 3 of them reported < 3 symptoms and 1 ≥ 3 symptoms, all exhibiting GOSE scores of 8. Loss of brain volume, demonstrated by computer-aided magnetic resonance imaging volumetry, may be a feasible marker of brain pathology after mild traumatic brain injury.