Outcome-based Risk Assessment of Non-HLA Antibodies in Heart Transplantation: A Systematic Review.

BACKGROUND: Current monitoring after heart transplantation (HT) employs repeated invasive endomyocardial biopsies (EMB). Although positive EMB confirms rejection, EMB fails to predict impending, subclinical, or EMB-negative rejection events. While non-human leukocyte antigen (non-HLA) antibodies have emerged as important risk factors for antibody-mediated rejection after HT, their use in clinical risk stratification has been limited. A systematic review of the role of non-HLA antibodies in rejection pathologies has the potential to guide efforts to overcome deficiencies of EMB in rejection monitoring. METHODS: Databases were searched to include studies on non-HLA antibodies in HT recipients. Data collected included the number of patients, type of rejection, non-HLA antigen studied, association of non-HLA antibodies with rejection, and evidence for synergistic interaction between non-HLA antibodies and donor-specific anti-human leukocyte antigen antibody (HLA-DSA) responses. RESULTS: A total of 56 studies met the inclusion criteria. Strength of evidence for each non-HLA antibody was evaluated based on the number of articles and patients in support versus against their role in mediating rejection. Importantly, despite previous intense focus on the role of anti-major histocompatibility complex class I chain-related gene A (MICA) and anti-angiotensin II type I receptor antibodies (AT1R) in HT rejection, evidence for their involvement was equivocal. Conversely, the strength of evidence for other non-HLA antibodies supports that differing rejection pathologies are driven by differing non-HLA antibodies. CONCLUSIONS: This systematic review underscores the importance of identifying peri-HT non-HLA antibodies. Current evidence supports the role of non-HLA antibodies in all forms of HT rejection. Further investigations are required to define the mechanisms of action of non-HLA antibodies in HT rejection.

Does the duration of ambulatory consultations affect the quality of healthcare? A systematic review.

BACKGROUND: The objective is to examine and synthesise the best available experimental evidence about the effect of ambulatory consultation duration on quality of healthcare. METHODS: We included experimental studies manipulating the length of outpatient clinical encounters between adult patients and clinicians (ie, therapists, pharmacists, nurses, physicians) to determine their effect on quality of care (ie, effectiveness, efficiency, timeliness, safety, equity, patient-centredness and patient satisfaction). INFORMATION SOURCES: Using controlled vocabulary and keywords, without restriction by language or year of publication, we searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials and Database of Systematic Reviews and Scopus from inception until 15 May 2023. RISK OF BIAS: Cochrane Risk of Bias instrument. DATA SYNTHESIS: Narrative synthesis. RESULTS: 11 publications of 10 studies explored the relationship between encounter duration and quality. Most took place in the UK's general practice over two decades ago. Study findings based on very sparse and outdated evidence-which suggested that longer consultations improved indicators of patient-centred care, education about prevention and clinical referrals; and that consultation duration was inconsistently related to patient satisfaction and clinical outcomes-warrant low confidence due to limited protections against bias and indirect applicability to current practice. CONCLUSION: Experimental evidence for a minimal or optimal duration of an outpatient consultation is sparse and outdated. To develop evidence-based policies and practices about encounter length, randomised trials of different consultation lengths-in person and virtually, and with electronic health records-are needed. TRIAL REGISTRATION NUMBER: OSF Registration DOI:10.17605/OSF.IO/EUDK8.

Systematic review of electronic health records to manage chronic conditions among displaced populations.

OBJECTIVES: The objective of this study was to assess the impact of electronic health records (EHRs) on health outcomes and care of displaced people with chronic health conditions and determine barriers and facilitators to EHR implementation in displaced populations. DESIGN: A systematic review protocol was developed according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Systematic Reviews. DATA SOURCES: MEDLINE, Embase, PsycINFO, CINAHL, Health Technology Assessment, Epub Ahead of Print, In-Process and Other Non-Indexed Citations, Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews was searched from inception to 12 April 2021. ELIGIBILITY CRITERIA FOR SELECTED STUDIES: Inclusion criteria were original research articles, case reports and descriptions of EHR implementation in populations of displaced people, refugees or asylum seekers with related chronic diseases. Grey literature, reviews and research articles unrelated to chronic diseases or the care of refugees or asylum populations were excluded. Studies were assessed for risk of bias using a modified Cochrane, Newcastle-Ottawa and Joanna Briggs Institute tools. DATA EXTRACTION AND SYNTHESIS: Two reviewers independently extracted data from each study using Covidence. Due to heterogeneity across study design and specific outcomes, a meta-analysis was not possible. An inductive thematic analysis was conducted using NVivo V.12 (QSR International, Melbourne, Australia). An inductive analysis was used in order to uncover patterns and themes in the experiences, general outcomes and perceptions of EHR implementation. RESULTS: A total of 32 studies across nine countries were included: 14 in refugee camps/settlements and 18 in asylum countries. Our analysis suggested that EHRs improve health outcomes for chronic diseases by increasing provider adherence to guidelines or treatment algorithms, monitoring of disease indicators, patient counselling and patient adherence. In asylum countries, EHRs resource allocation to direct clinical care and public health services, as well as screening efforts. EHR implementation was facilitated by their adaptability and ability to integrate into management systems. However, barriers to EHR development, deployment and data analysis were identified in refugee settings. CONCLUSION: Our results suggest that well-designed and integrated EHRs can be a powerful tool to improve healthcare systems and chronic disease outcomes in refugee settings. However, attention should be paid to the common barriers and facilitating actions that we have identified such as utilising a user-centred design. By implementing adaptable EHR solutions, health systems can be strengthened, providers better supported and the health of refugees improved.

Costs and Economic Impacts of Physician Continuous Professional Development: A Systematic Scoping Review.

PURPOSE: Nearly all health care professionals engage in continuous professional development (CPD), yet little is known about the cost and cost-effectiveness of physician CPD. Clarification of key concepts, comprehensive identification of published work, and determination of research gaps would facilitate application of existing evidence and planning for future investigations. The authors sought to systematically map study themes, methods, and outcomes in peer-reviewed literature on the cost and value of physician CPD. METHOD: The authors conducted a scoping review, systematically searching MEDLINE, Embase, PsycInfo, and Cochrane Library databases for comparative economic evaluations of CPD for practicing physicians through April 2020. Two reviewers, working independently, screened all articles for inclusion. Three reviewers iteratively reviewed all included articles to inductively identify key features including participants, educational interventions, study designs, cost ingredients, and cost analyses. Two reviewers then independently reexamined all included articles to code these features. RESULTS: Of 3,338 potentially eligible studies, 111 were included. Physician specialties included internal, family, or general medicine (80 studies [72%]), surgery (14 studies [13%]), and medicine subspecialties (7 studies [6%]). Topics most often addressed general medicine (45 studies [41%]) or appropriate drug use (37 studies [33%]). Eighty-seven studies (78%) compared CPD with no intervention. Sixty-three studies (57%) reported the cost of training, and 79 (71%) evaluated the economic impact (money saved/lost following CPD). Training cost ingredients (median 3 itemized per study) and economic impact ingredients (median 1 per study) were infrequently and incompletely identified, quantified, or priced. Twenty-seven studies (24%) reported cost-impact expressions such as cost-effectiveness ratio or net value. Nineteen studies (17%) reported sensitivity analyses. CONCLUSIONS: Studies evaluating the costs and economic impact of physician CPD are few. Gaps exist in identification, quantification, pricing, and analysis of cost outcomes. The authors propose a comprehensive framework for appraising ingredients and a preliminary reference case for economic evaluations.

Interventions supporting cost conversations between patients and clinicians: A systematic review.

BACKGROUND AND AIM: Discussing cost during medical encounters may decrease the financial impact of medical care on patients and align their treatment plans with their financial capacities. We aimed to examine which interventions exist and quantify their effectiveness to support cost conversations. METHODS: Several databases were queried (Embase; Ovid MEDLINE(R); Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Daily; the Cochrane databases; and Scopus) from their inception until January 31, 2020 using terms such as "clinician*", "patient*", "cost*", and "conversation*". Eligibility assessment, data extraction and risk of bias assessment were performed independently and in duplicate. We extracted study setting, design, intervention characteristics and outcomes related to patients, clinicians and quality metrics. RESULTS: We identified four studies (1327 patients) meeting our inclusion criteria. All studies were non-randomised and conducted in the United States. Three were performed in a primary care setting and the fourth in an oncology. Two studies used decision aids that included cost information; one used a training session for health care staff about cost conversations, and the other directly delivered information regarding cost conversations to patients. All interventions increased cost-conversation frequency. There was no effect on out-of-pocket costs, satisfaction, medication adherence or understanding of costs of care. CONCLUSION: The body of evidence is small and comprised of studies at high risk of bias. However, an increase in the frequency of cost conversations is consistent. Studies with higher quality are needed to ascertain the effects of these interventions on the acceptability, frequency and quality of cost conversations.

The validity of cost-effectiveness analyses of tight glycemic control. A systematic survey of economic evaluations of pharmacological interventions in patients with type 2 diabetes.

PURPOSE: Currently available randomized trial evidence has shown no reductions in type 2 diabetes (T2D) complications important to patients with tight glycemic control. Yet, economic analyses consistently find tight glycemic control to be cost-effective. To understand this apparent paradox, we systematically identified and appraised economic analyses of tight glycemic control for T2D. METHODS: We searched multiple databases from January 2016 to January 2018 for cost-effectiveness or cost-utility analyses of any glucose-lowering treatments for adults with T2D using simulations with long-40 years to lifetime-time horizons. Reviewers selected and appraised each study independently and in duplicate with good reproducibility. RESULTS: We found 30 analyses, most comparing the glycemic impact of glucose-lowering drugs and applying their impact on HbA1c to model (most commonly IMS CORE or Cardiff T2DM) their impact on the incidence of diabetes-related complication. Models drew from observational evidence of the correlation of HbA1c levels and diabetes-related complication rates; none used estimates of the effect of lowering HbA1c on these outcomes from systematic reviews of randomized trials. Sensitivity analyses, when conducted, demonstrate substantial loss of cost-effectiveness as simulations approach the results seen in these trials. CONCLUSIONS: Reliance on the association between glycemic control and diabetes-related complications evident in observational studies but not apparent in randomized trial bias the estimates of the cost-effectiveness of interventions to improve glycemic control.

Systematic review of the evidence on the cost-effectiveness of pharmacogenomics-guided treatment for cardiovascular diseases.

PURPOSE: To examine the evidence on the cost-effectiveness of implementing pharmacogenomics (PGx) in cardiovascular disease (CVD) care. METHODS: We conducted a systematic review using multiple databases from inception to 2018. The titles and abstracts of cost-effectiveness studies on PGx-guided treatment in CVD care were screened, and full texts were extracted. RESULTS: We screened 909 studies and included 46 to synthesize. Acute coronary syndrome and atrial fibrillation were the predominantly studied conditions (59%). Most studies (78%) examined warfarin-CYP2C9/VKORC1 or clopidogrel-CYP2C19. A payer's perspective was commonly used (39%) for cost calculations, and most studies (46%) were US-based. The majority (67%) of the studies found PGx testing to be cost-effective in CVD care, but cost-effectiveness varied across drugs and conditions. Two studies examined PGx panel testing, of which one examined pre-emptive testing strategies. CONCLUSION: We found mixed evidence on the cost-effectiveness of PGx in CVD care. Supportive evidence exists for clopidogrel-CYP2C19 and warfarin-CYP2C9/VKORC1, but evidence is limited in other drug-gene combinations. Gaps persist, including unclear explanation of perspective and cost inputs, underreporting of study design elements critical to economic evaluations, and limited examination of PGx panel and pre-emptive testing for their cost-effectiveness. This review identifies the need for further research on economic evaluations of PGx implementation.

Creating a Patient-Centered Health Care Delivery System: A Systematic Review of Health Care Quality From the Patient Perspective.

Patient experience is one of key domains of value-based purchasing that can serve as a measure of quality and be used to improve the delivery of health services. The aims of this study are to explore patient perceptions of quality of health care and to understand how perceptions may differ by settings and condition. A systematic review of multiple databases was conducted for studies targeting patient perceptions of quality of care. Two reviewers screened and extracted data independently. Data synthesis was performed following a meta-narrative approach. A total of 36 studies were included that identified 10 quality dimensions perceived by patients: communication, access, shared decision making, provider knowledge and skills, physical environment, patient education, electronic medical record, pain control, discharge process, and preventive services. These dimensions can be used in planning and evaluating health care delivery. Future research should evaluate the effect of interventions targeting patient experience on patient outcomes.

A systematic review of treatment of intermittent claudication in the lower extremities.

BACKGROUND: Peripheral arterial disease is common and is associated with significant morbidity and mortality. METHODS: We conducted a systematic review to identify randomized trials and systematic reviews of patients with intermittent claudication to evaluate surgery, endovascular therapy, and exercise therapy. Outcomes of interest were death, amputation, walking distance, quality of life, measures of blood flow, and cost. RESULTS: We included eight systematic reviews and 12 trials enrolling 1548 patients. Data on mortality and amputation and on cost-effectiveness were sparse. Compared with medical management, each of the three treatments (surgery, endovascular therapy, and exercise therapy) was associated with improved walking distance, claudication symptoms, and quality of life (high-quality evidence). Evidence supporting superiority of one of the three approaches was limited. However, blood flow parameters improved faster and better with both forms of revascularization compared with exercise or medical management (low- to moderate-quality evidence). Compared with endovascular therapy, open surgery may be associated with longer length of hospital stay and higher complication rate but resulted in more durable patency (moderate-quality evidence). CONCLUSIONS: In patients with claudication, open surgery, endovascular therapy, and exercise therapy were superior to medical management in terms of walking distance and claudication. Choice of therapy should rely on patients' values and preferences, clinical context, and availability of operative expertise.

Health assessment of commercial drivers: a meta-narrative systematic review.

BACKGROUND: Motor vehicle accidents associated with commercial driving are an important cause of occupational death and impact public safety. OBJECTIVES: We summarise the evidence regarding the type, prevalence and impact of medical conditions discovered during health assessment of commercial drivers. EVIDENCE REVIEW: We conducted a systematic review of multiple electronic databases and made a manual search for relevant studies that enrolled commercial drivers in any country and reported the outcomes of health assessment carried out in the context of commercial driving through November 2012. Data were extracted by a pair of independent reviewers and synthesised using a metanarrative approach. RESULTS: We identified 32 studies of moderate methodological quality enrolling 151 644 commercial drivers (98% men). The prevalence of multiple health conditions was high (sleep disorders 19%, diabetes 33%, hypertension 23% and obesity 45%). Some conditions, such as sleep disorders and obesity, were linked to increased risk of crashes. Evidence on several other highly relevant medical conditions was lacking. Cost-effectiveness data were sparse. CONCLUSIONS: Several medical conditions are highly prevalent in commercial drivers and can be associated with increased risk of crashes, thus providing a rationale for health assessment of commercial drivers.

Care coordination to enhance management of long-term enteral tube feeding: a systematic review and meta-analysis.

BACKGROUND: A systematic review and meta-analysis was completed to summarize care delivery models that used care coordination and/or team approach methods in the management of patients requiring long-term enteral tube feeding. Our aim was to evaluate team composition, implementation strategies, and the effectiveness of these methods. METHODS: We conducted a broad search of 7 databases from inception to May 2012, cross-referenced clinical reviews and medical guidelines, and consulted clinical experts. Independent reviewers screened eligible studies, extracted data, and assessed study quality. RESULTS: Fifteen studies enrolling 2145 patients were included in this review. The studies described multidisciplinary teams composed of primary care physicians, specialists, nurses, dietitians, and language or speech specialists. Patients and their families/caregivers were also an important part of the care team. The interventions were multifaceted and employed multiple simultaneous strategies that particularly included patient and family education, staff education, and continuous auditing and feedback methods. Meta-analysis suggested no significant reductions in complications (incidence rate ratio [IRR], 0.53; 95% confidence interval [CI], 0.27-1.05), infections (IRR, 0.77; 95% CI, 0.48-1.24), and overall hospital admissions (IRR, 0.36; 95% CI, 0.13-1.00) most likely due to lack of statistical power. We found significant reduction of total hospital costs (estimates in US dollars: -623.08; 95% CI, -745.64 to -500.53; P < .01) after the interventions. CONCLUSION: Studies suggested a positive association of care coordination by a multidisciplinary team approach and improved patient outcomes for long-term enteral feeding patients. However, the available evidence does not allow estimating the effectiveness of a particular intervention or team composition.

Ageism vs. the technical imperative, applying the GRADE framework to the evidence on hemodialysis in very elderly patients.

PURPOSE: Treatment intensity for elderly patients with end-stage renal disease has escalated beyond population growth. Ageism seems to have given way to a powerful imperative to treat patients irrespective of age, prognosis, or functional status. Hemodialysis (HD) is a prime example of this trend. Recent articles have questioned this practice. This paper aims to identify existing pre-synthesized evidence on HD in the very elderly and frame it from the perspective of a clinician who needs to involve their patient in a treatment decision. PATIENTS AND METHODS: A comprehensive search of several databases from January 2002 to August 2012 was conducted for systematic reviews of clinical and economic outcomes of HD in the elderly. We also contacted experts to identify additional references. We applied the rigorous framework of decisional factors of the Grading of Recommendation, Assessment, Development and Evaluation (GRADE) to evaluate the quality of evidence and strength of recommendations. RESULTS: We found nine eligible systematic reviews. The quality of the evidence to support the current recommendation of HD initiation for most very elderly patients is very low. There is significant uncertainty in the balance of benefits and risks, patient preference, and whether default HD in this patient population is a wise use of resources. CONCLUSION: Following the GRADE framework, recommendation for HD in this population would be weak. This means it should not be considered standard of care and should only be started based on the well-informed patient's values and preferences. More studies are needed to delineate the true treatment effect and to guide future practice and policy.

Endocrine clinical practice guidelines in North America. A systematic assessment of quality.

OBJECTIVE: To assess the quality of endocrine guidelines developed in North America. STUDY DESIGN AND SETTING: A systematic review of the literature was conducted to identify all endocrine clinical practice guidelines developed in North America and published between January 1, 2007 and January 13, 2010. Two independent reviewers used the Appraisal of Guidelines, Research and Evaluation instrument to evaluate the quality of the guidelines in six domains: scope and purpose, stakeholder involvement, rigor of development, clarity and presentation, applicability, and editorial independence. RESULTS: One hundred eligible endocrine guidelines had high scores in the scope-and-purpose (mean pooled standardized score [MPSD] of 82±14) and clarity domains (MPSD=64±17) and low scores in the stakeholder-involvement (MPSD of 36±12) and editorial independence domains (MPSD=36±36). Only 29% of guidelines scored above 60% for more than three domains. Rigor-of-development domain score was significantly higher in guidelines using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach, nondiabetes guidelines, and in published in-print vs. online publications. CONCLUSIONS: The quality of endocrine guidelines published in 2007-2009 is moderate and can be improved by (1) using methodologically sound development frameworks, (2) increasing stakeholder involvement, and (3) paying more attention to resource implications of guideline implementation.