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JPMA. the Journal of the Pakistan... Aug 2023To map literature on research ethics committees, institutional review boards and ethics review framework in Pakistan to identify key insights during public health...
OBJECTIVE
To map literature on research ethics committees, institutional review boards and ethics review framework in Pakistan to identify key insights during public health emergencies and normal times.
METHOD
The systematic scoping review was conducted in April 2022, and comprised literature search on PubMed, World Health Organisation Global Index Medicus and Summons databases for articles published between January 2005 and February 2022. Information extracted included authors' names, year of publication, title, study methodology, and key insights under the heads of challenges and solutions. Due to data heterogeneity, key themes were identified and analysed.
RESULTS
Of the 2,190 studies initially identified, 21(0.95%) were subjected to full-text review, and, from among them, 9(45%) were analysed in detail. There were 4 key insights identified: research ethics committees and institutional review boards in Pakistan remain unregulated as they are currently not registered or accredited by a competent national-level authority; most members of such committees are not formally trained to implement the mandate; internal and external pressures hinder independent decision-making of such committees; and other issues hindering the functionality and performance of research ethics committees and institutional review boards.
CONCLUSIONS
Despite existing publications calling for urgent policy and regulatory reforms, there is a dearth of literature and minimal policy actions underlying the fact that ethics review remains a neglected area in Pakistan.
Topics: Humans; Pakistan; Ethics Committees, Research; Learning; Databases, Factual
PubMed: 37697760
DOI: 10.47391/JPMA.8033 -
The Lancet. Diabetes & Endocrinology Oct 2023Reference intervals of thyroid-stimulating hormone (TSH) and free thyroxine (FT) are statistically defined by the 2·5-97·5th percentiles, without accounting for... (Meta-Analysis)
Meta-Analysis
The optimal healthy ranges of thyroid function defined by the risk of cardiovascular disease and mortality: systematic review and individual participant data meta-analysis.
BACKGROUND
Reference intervals of thyroid-stimulating hormone (TSH) and free thyroxine (FT) are statistically defined by the 2·5-97·5th percentiles, without accounting for potential risk of clinical outcomes. We aimed to define the optimal healthy ranges of TSH and FT based on the risk of cardiovascular disease and mortality.
METHODS
This systematic review and individual participant data (IPD) meta-analysis identified eligible prospective cohorts through the Thyroid Studies Collaboration, supplemented with a systematic search via Embase, MEDLINE (Ovid), Web of science, the Cochrane Central Register of Controlled Trials, and Google Scholar from Jan 1, 2011, to Feb 12, 2017 with an updated search to Oct 13, 2022 (cohorts found in the second search were not included in the IPD). We included cohorts that collected TSH or FT, and cardiovascular outcomes or mortality for adults (aged ≥18 years). We excluded cohorts that included solely pregnant women, individuals with overt thyroid diseases, and individuals with cardiovascular disease. We contacted the study investigators of eligible cohorts to provide IPD on demographics, TSH, FT, thyroid peroxidase antibodies, history of cardiovascular disease and risk factors, medication use, cardiovascular disease events, cardiovascular disease mortality, and all-cause mortality. The primary outcome was a composite outcome including cardiovascular disease events (coronary heart disease, stroke, and heart failure) and all-cause mortality. Secondary outcomes were the separate assessment of cardiovascular disease events, all-cause mortality, and cardiovascular disease mortality. We performed one-step (cohort-stratified Cox models) and two-step (random-effects models) meta-analyses adjusting for age, sex, smoking, systolic blood pressure, diabetes, and total cholesterol. The study was registered with PROSPERO, CRD42017057576.
FINDINGS
We identified 3935 studies, of which 53 cohorts fulfilled the inclusion criteria and 26 cohorts agreed to participate. We included IPD on 134 346 participants with a median age of 59 years (range 18-106) at baseline. There was a J-shaped association of FT with the composite outcome and secondary outcomes, with the 20th (median 13·5 pmol/L [IQR 11·2-13·9]) to 40th percentiles (median 14·8 pmol/L [12·3-15·0]) conveying the lowest risk. Compared with the 20-40th percentiles, the age-adjusted and sex-adjusted hazard ratio (HR) for FT in the 80-100th percentiles was 1·20 (95% CI 1·11-1·31) for the composite outcome, 1·34 (1·20-1·49) for all-cause mortality, 1·57 (1·31-1·89) for cardiovascular disease mortality, and 1·22 (1·11-1·33) for cardiovascular disease events. In individuals aged 70 years and older, the 10-year absolute risk of composite outcome increased over 5% for women with FT greater than the 85th percentile (median 17·6 pmol/L [IQR 15·0-18·3]), and men with FT greater than the 75th percentile (16·7 pmol/L [14·0-17·4]). Non-linear associations were identified for TSH, with the 60th (median 1·90 mIU/L [IQR 1·68-2·25]) to 80th percentiles (2·90 mIU/L [2·41-3·32]) associated with the lowest risk of cardiovascular disease and mortality. Compared with the 60-80th percentiles, the age-adjusted and sex-adjusted HR of TSH in the 0-20th percentiles was 1·07 (95% CI 1·02-1·12) for the composite outcome, 1·09 (1·05-1·14) for all-cause mortality, and 1·07 (0·99-1·16) for cardiovascular disease mortality.
INTERPRETATION
There was a J-shaped association of FT with cardiovascular disease and mortality. Low concentrations of TSH were associated with a higher risk of all-cause mortality and cardiovascular disease mortality. The 20-40th percentiles of FT and the 60-80th percentiles of TSH could represent the optimal healthy ranges of thyroid function based on the risk of cardiovascular disease and mortality, with more than 5% increase of 10-year composite risk identified for FT greater than the 85th percentile in women and men older than 70 years. We propose a feasible approach to establish the optimal healthy ranges of thyroid function, allowing for better identification of individuals with a higher risk of thyroid-related outcomes.
FUNDING
None.
Topics: Male; Adult; Humans; Female; Pregnancy; Aged; Aged, 80 and over; Adolescent; Young Adult; Middle Aged; Thyroid Gland; Thyroid Function Tests; Thyroxine; Prospective Studies; Cardiovascular Diseases; Thyrotropin
PubMed: 37696273
DOI: 10.1016/S2213-8587(23)00227-9 -
Design, delivery and effectiveness of health practitioner regulation systems: an integrative review.Human Resources For Health Sep 2023Health practitioner regulation (HPR) systems are increasingly recognized as playing an important role in supporting health workforce availability, accessibility,...
BACKGROUND
Health practitioner regulation (HPR) systems are increasingly recognized as playing an important role in supporting health workforce availability, accessibility, quality, and sustainability, while promoting patient safety. This review aimed to identify evidence on the design, delivery and effectiveness of HPR to inform policy decisions.
METHODS
We conducted an integrative analysis of literature published between 2010 and 2021. Fourteen databases were systematically searched, with data extracted and synthesized based on a modified Donabedian framework.
FINDINGS
This large-scale review synthesized evidence from a range of academic (n = 410) and grey literature (n = 426) relevant to HPR. We identified key themes and findings for a series of HPR topics organized according to our structures-processes-outcomes conceptual framework. Governance reforms in HPR are shifting towards multi-profession regulators, enhanced accountability, and risk-based approaches; however, comparisons between HPR models were complicated by a lack of a standardized HPR typology. HPR can support government workforce strategies, despite persisting challenges in cross-border recognition of qualifications and portability of registration. Scope of practice reform adapted to modern health systems can improve access and quality. Alternatives to statutory registration for lower-risk health occupations can improve services and protect the public, while standardized evaluation frameworks can aid regulatory strengthening. Knowledge gaps remain around the outcomes and effectiveness of HPR processes, including continuing professional development models, national licensing examinations, accreditation of health practitioner education programs, mandatory reporting obligations, remediation programs, and statutory registration of traditional and complementary medicine practitioners.
CONCLUSION
We identified key themes, issues, and evidence gaps valuable for governments, regulators, and health system leaders. We also identified evidence base limitations that warrant caution when interpreting and generalizing the results across jurisdictions and professions. Themes and findings reflect interests and concerns in high-income Anglophone countries where most literature originated. Most studies were descriptive, resulting in a low certainty of evidence. To inform regulatory design and reform, research funders and governments should prioritize evidence on regulatory outcomes, including innovative approaches we identified in our review. Additionally, a systematic approach is needed to track and evaluate the impact of regulatory interventions and innovations on achieving health workforce and health systems goals.
Topics: Humans; Government Programs; Government; Accreditation; Databases, Factual; Health Education
PubMed: 37667368
DOI: 10.1186/s12960-023-00848-y -
Journal of Vascular Surgery. Venous and... Jan 2024The Society for Vascular Surgery, the American Venous Forum, and the American Vein and Lymphatic Society recently published Part I of the 2022 clinical practice... (Meta-Analysis)
Meta-Analysis
The 2023 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part II: Endorsed by the Society of Interventional Radiology and the Society for Vascular Medicine.
The Society for Vascular Surgery, the American Venous Forum, and the American Vein and Lymphatic Society recently published Part I of the 2022 clinical practice guidelines on varicose veins. Recommendations were based on the latest scientific evidence researched following an independent systematic review and meta-analysis of five critical issues affecting the management of patients with lower extremity varicose veins, using the patients, interventions, comparators, and outcome system to answer critical questions. Part I discussed the role of duplex ultrasound scanning in the evaluation of varicose veins and treatment of superficial truncal reflux. Part II focuses on evidence supporting the prevention and management of varicose vein patients with compression, on treatment with drugs and nutritional supplements, on evaluation and treatment of varicose tributaries, on superficial venous aneurysms, and on the management of complications of varicose veins and their treatment. All guidelines were based on systematic reviews, and they were graded according to the level of evidence and the strength of recommendations, using the GRADE method. All ungraded Consensus Statements were supported by an extensive literature review and the unanimous agreement of an expert, multidisciplinary panel. Ungraded Good Practice Statements are recommendations that are supported only by indirect evidence. The topic, however, is usually noncontroversial and agreed upon by most stakeholders. The Implementation Remarks contain technical information that supports the implementation of specific recommendations. This comprehensive document includes a list of all recommendations (Parts I-II), ungraded consensus statements, implementation remarks, and best practice statements to aid practitioners with appropriate, up-to-date management of patients with lower extremity varicose veins.
Topics: Humans; United States; Venous Insufficiency; Radiology, Interventional; Sclerotherapy; Saphenous Vein; Treatment Outcome; Varicose Veins; Vascular Surgical Procedures; Lower Extremity; Cardiology
PubMed: 37652254
DOI: 10.1016/j.jvsv.2023.08.011 -
Circulation. Cardiovascular... Sep 2023Short-term (≤6 months) dual antiplatelet therapy (DAPT) and DAPT de-escalation become attractive for patients with acute coronary syndrome. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Short-term (≤6 months) dual antiplatelet therapy (DAPT) and DAPT de-escalation become attractive for patients with acute coronary syndrome.
METHODS
A systemic search identified randomized controlled trials that included patients with acute coronary syndrome treated using (1) standard DAPT (12 months) with clopidogrel, prasugrel (standard/low dose), or ticagrelor; (2) extended DAPT (≥18 months); (3) short-term DAPT (≤6 months) followed by P2Y inhibitor or aspirin; (4) 12-month DAPT with unguided de-escalation from potent P2Y inhibitors to low-dose potent P2Y inhibitor or clopidogrel at 1 month; and (5) guided selection DAPT with genotype or platelet function tests. The primary efficacy outcome (major adverse cardiovascular events) was a composite of cardiovascular death, myocardial infarction, or stroke. The primary safety outcome was major or minor bleeding.
RESULTS
This meta-analysis included 32 randomized controlled trials with 103 497 patients. While there were no differences in efficacy between short, unguided de-escalation and guided selection strategies, unguided de-escalation was associated with reduced risk of major adverse cardiovascular events compared with standard DAPT with clopidogrel or ticagrelor (hazard ratio [95% CI], 0.67 [0.49-0.93] and 0.68 [0.50-0.93]). Both short DAPT followed by P2Y inhibitor and unguided de-escalation were associated with reduced risks in safety compared with other strategies, including guided selection (hazard ratio [95% CI], 0.66 [0.47-0.93] and 0.48 [0.33-0.71]). Short DAPT followed by a P2Y inhibitor was associated with reduced risk of major bleeding and all-cause death compared with standard, extended DAPT (eg, versus DAPT with clopidogrel; hazard ratio [95% CI], 0.64 [0.42-0.97] and 0.60 [0.44-0.82]). By rankogram, unguided de-escalation strategy was the safest and most effective strategy in reducing major adverse cardiovascular events and major or minor bleeding while short DAPT followed by P2Y inhibitor was ranked the best for major bleeding and all-cause death.
CONCLUSIONS
In patients with acute coronary syndrome, unguided de-escalation was associated with the lowest risk of major adverse cardiovascular events and major or minor bleeding outcomes, while short DAPT followed by P2Y inhibitor was associated with the lowest risk of major bleeding and all-cause death.
Topics: Humans; Acute Coronary Syndrome; Platelet Aggregation Inhibitors; Network Meta-Analysis; Clopidogrel; Ticagrelor; Treatment Outcome
PubMed: 37609850
DOI: 10.1161/CIRCINTERVENTIONS.123.013242 -
Joint Commission Journal on Quality and... Nov 2023Resident physician work hour limits continue to be controversial. Numerous trials have come to conflicting conclusions about the impact on patient safety of eliminating... (Meta-Analysis)
Meta-Analysis
Resident physician work hour limits continue to be controversial. Numerous trials have come to conflicting conclusions about the impact on patient safety of eliminating extended duration work shifts. We conducted meta-analyses to evaluate the impact of work hour policies and work schedules on patient safety. After identifying 8,362 potentially relevant studies and reviewing 688 full-text articles, 132 studies were retained and graded on quality of evidence. Of these, 68 studies provided enough information for consideration in meta-analyses. We found that patient safety improved following implementation of the Accreditation Council for Graduate Medical Education's 2003 and 2011 resident physicians work hour guidelines. Limiting all resident physicians to 80-hour work weeks and 28-hour shifts in 2003 was associated with an 11% reduction in mortality (p < 0.001). Limited shift durations and shorter work weeks were also associated with improved patient safety in clinical trials and observational studies not specifically tied to policy changes. Given the preponderance of evidence showing that patient and physician safety is negatively affected by long work hours, efforts to improve physician schedules should be prioritized. Policies that enable extended-duration shifts and long work weeks should be reexamined. Further research should expand beyond resident physicians to additional study populations, including attending physicians and other health care workers.
Topics: Humans; Internship and Residency; Patient Safety; Personnel Staffing and Scheduling; Physicians; Work Schedule Tolerance; Workload
PubMed: 37543449
DOI: 10.1016/j.jcjq.2023.06.014 -
Nurse Education in Practice Aug 2023The clinical learning environment offers meaningful learning opportunities for nursing students to apply theoretical knowledge to practice on actual or simulated... (Review)
Review
OBJECTIVES
The clinical learning environment offers meaningful learning opportunities for nursing students to apply theoretical knowledge to practice on actual or simulated patients. A previous systematic review assessed the quality of several instruments that evaluated the quality of clinical learning environments. This updated systematic review aimed to identify: any additional instruments that have been researched in the last 5 years, ii) the psychometric properties of available instruments and iii) the estimated comparable psychometric properties of the available instruments.
DATA SOURCES
Medline, CINAHL and Cochrane databases REVIEW METHODS: Databases were searched from January 2016 to January 2023. Studies were included if they: a) validated instruments evaluating the experience and quality of clinical learning environments; b) assessed the pre-licensure nursing student experience; c) were published in English; and d) were published after April 2016. Two independent reviewers conducted title and abstract screening, full text screening, data extraction and methodological quality assessment. Any disagreements were resolved by consensus. A summary of the findings was tabulated using the same format as the initial review.
RESULTS
An additional 18 studies were found, which used seven different clinical learning environment evaluation instruments. Internal consistency and structural validity were the most frequently reported psychometric properties. In almost all studies, methodology for these properties were of sufficient quality according to the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) tool evaluation. Other properties were inconsistently reported, with differing qualities in the methodology. Clinical Learning Environment, Supervision and Nurse Teacher (CLES + T) remains the most translated and validated instrument across several countries.
CONCLUSIONS
Instruments developed and validated using a systematic, transparent and high-quality methodology assist in accurately assessing the skills, attitudes and decision-making abilities of the preregistration level nursing student. These tools can be used in clinical placement accreditation and quality improvement of nursing education. The methodology for evaluation of the psychometric properties of instruments should be clearly described.
Topics: Humans; Education, Nursing; Learning; Students, Nursing; Clinical Competence; Psychometrics; Reproducibility of Results
PubMed: 37536179
DOI: 10.1016/j.nepr.2023.103732 -
American Journal of Physical Medicine &... Apr 2024This review aimed to compare the effectiveness of resistance exercise with that of other exercises in functional improvement and pain control in patients with... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
This review aimed to compare the effectiveness of resistance exercise with that of other exercises in functional improvement and pain control in patients with fibromyalgia.
DESIGN
PubMed, Embase, Scopus, and Cochrane databases were searched for studies published from their inception until March 2023. The following medical search heading terms were used: "resistance OR strength OR strengthening" AND "fibromyalgia." The analysis was performed using the statistical package Review Manager, version 5.4.1.
RESULTS
This study reviewed 11 randomized controlled trials involving 530 patients. In comparison with no intervention, resistance exercise reduced the Fibromyalgia Impact Questionnaire total score, pain score, tender points, and depression and improved physical function. Compared with flexibility exercise, resistance exercise reduced the Fibromyalgia Impact Questionnaire total score. Compared with aerobic exercise, resistance exercise shows similar effects on pain control, reduction of tender points, and improvement of physical function.
CONCLUSIONS
Compared with other exercises, resistance exercise demonstrated a more favorable effect on the Fibromyalgia Impact Questionnaire total score, and the effects on pain control, tender points, physical function, and depression were comparable. Thus, resistance exercise exhibits comparable or superior effects when compared with other interventions and more precise research is needed to confirm this conclusion.
TO CLAIM CME CREDITS
Complete the self-assessment activity and evaluation online at http://www.physiatry.org/JournalCME.
CME OBJECTIVES
Upon completion of this article, the reader should be able to: (1) Appraise the effectiveness and role of resistance exercise as a treatment option for patients with fibromyalgia; (2) Differentiate the comparative effectiveness of resistance exercise in relation to other forms of exercise for patients with fibromyalgia; and (3) Identify demographic factors commonly associated with fibromyalgia.
LEVEL
Advanced.
ACCREDITATION
The Association of Academic Physiatrists is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.The Association of Academic Physiatrists designates this Journal-based CME activity for a maximum of 1.0 AMA PRA Category 1 Credit(s) ™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
Topics: Humans; Fibromyalgia; Resistance Training; Randomized Controlled Trials as Topic; Exercise; Pain
PubMed: 37535560
DOI: 10.1097/PHM.0000000000002318 -
BMC Medical Education Jul 2023The purpose of this systematic review was to (1) determine the scope of literature measuring USMLE Step 1 and Step 2 CK as predictors or indicators of quality resident...
BACKGROUND
The purpose of this systematic review was to (1) determine the scope of literature measuring USMLE Step 1 and Step 2 CK as predictors or indicators of quality resident performance across all medical specialties and (2) summarize the ability of Step 1 and Step 2 CK to predict quality resident performance, stratified by ACGME specialties, based on available literature.
METHODS
This systematic review was designed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) [16]. The original search strategy surveyed MEDLINE and was adapted to survey Cochrane Library and Embase. A study was deemed eligible if it provided all three of the following relevant information: (a) Step 1 or Step 2 CK as indicators for (b) resident outcomes in (c) any ACGME accredited specialty training program.
RESULTS
A total of 1803 articles were screened from three separate databases. The 92 included studies were stratified by specialty, with Surgery (21.7% [20/92]), Emergency Medicine (13.0% [12/92]), Internal Medicine (10.9% [10/92]), and Orthopedic Surgery (8.7% [8/92]) being the most common. Common resident performance measures included ITE scores, board certification, ACGME milestone ratings, and program director evaluations.
CONCLUSIONS
Further studies are imperative to discern the utility of Step 1 and Step 2 CK as predictors of resident performance and as tools for resident recruitment and selection. The results of this systematic review suggest that a scored Step 1 dated prior to January 2022 can be useful as a tool in a holistic review of future resident performance, and that Step 2 CK score performance may be an effective tool in the holistic review process. Given its inherent complexity, multiple tools across many assessment modalities are necessary to assess resident performance comprehensively and effectively.
Topics: Humans; United States; Educational Measurement; Internship and Residency; Clinical Competence; Licensure, Medical; Internal Medicine
PubMed: 37525136
DOI: 10.1186/s12909-023-04530-8 -
Clinical Research in Cardiology :... Apr 2024Recent randomized controlled trials did not show benefit of early/immediate coronary angiography (CAG) over a delayed/selective strategy in patients with out-of-hospital... (Meta-Analysis)
Meta-Analysis
Early versus delayed coronary angiography in patients with out-of-hospital cardiac arrest and no ST-segment elevation: a systematic review and meta-analysis of randomized controlled trials.
BACKGROUND
Recent randomized controlled trials did not show benefit of early/immediate coronary angiography (CAG) over a delayed/selective strategy in patients with out-of-hospital cardiac arrest (OHCA) and no ST-segment elevation. However, whether selected subgroups, specifically those with a high pretest probability of coronary artery disease may benefit from early CAG remains unclear.
METHODS
We included all randomized controlled trials that compared a strategy of early/immediate versus delayed/selective CAG in OHCA patients and no ST elevation and had a follow-up of at least 30 days. The primary outcome of interest was all-cause death. Odds ratios (OR) were calculated and pooled across trials. Interaction testing was used to assess for heterogeneity of treatment effects.
RESULTS
In total, 1512 patients (67 years, 26% female, 23% prior myocardial infarction) were included from 5 randomized controlled trials. Early/immediate versus delayed/selective CAG was not associated with a statistically significant difference in odds of death (OR 1.12, 95%-CI 0.91-1.38), with similar findings for the composite outcome of all-cause death or neurological deficit (OR 1.10, 95%-CI 0.89-1.36). There was no effect modification for death by age, presence of a shockable initial cardiac rhythm, history of coronary artery disease, presence of an ischemic event as the presumed cause of arrest, or time to return of spontaneous circulation (all P-interaction > 0.10). However, early/immediate CAG tended to be associated with higher odds of death in women (OR 1.52, 95%-CI 1.00-2.31, P = 0.050) than in men (OR 1.04, 95%-CI 0.82-1.33, P = 0.74; P-interaction 0.097).
CONCLUSION
In OHCA patients without ST-segment elevation, a strategy of early/immediate versus delayed/selective CAG did not reduce all-cause mortality across major subgroups. However, women tended to have higher odds of death with early CAG.
Topics: Male; Humans; Female; Coronary Angiography; Coronary Artery Disease; Out-of-Hospital Cardiac Arrest; Cardiopulmonary Resuscitation; Randomized Controlled Trials as Topic; Percutaneous Coronary Intervention
PubMed: 37495798
DOI: 10.1007/s00392-023-02264-7