The GRADE Working Group and CINeMA approaches provided inconsistent certainty of evidence ratings for a network meta-analysis of opioids for chronic noncancer pain

Objective:To provide procedure-specific estimates of symptomatic venous thromboembolism (VTE) and major bleeding after abdominal surgery.Background:The use of pharmacological thromboprophylaxis represents a trade-off that depends on VTE and bleeding risks that vary between procedures; their magnitude remains uncertain.Methods:We identified observational studies reporting procedure-specific risks of symptomatic VTE or major bleeding after abdominal surgery, adjusted the reported estimates for thromboprophylaxis and length of follow-up, and estimated cumulative incidence at 4 weeks postsurgery, stratified by VTE risk groups, and rated evidence certainty.Results:

We report the short-and long-term results of the SOLIDARITY Finland on mortality and other patient-important outcomes in patients hospitalised for COVID-19. Between 08/2021 and 03/2023, we randomised 156 patients in 15 hospitals. In the imatinib group, 7.2% of patients had died at 30 days and 13.3% at 1 year and in the standard of care group 4.1% and 8.3%(adjusted HR at 30 days 1.09, 95% CI 0.23-5.07). In a meta-analysis of randomised trials of imatinib versus standard of care (n= 732), allocation to imatinib was associated with a mortality risk ratio of 0.73 (95% CI 0.32-1.63). At 1-year, self-reported recovery occurred in 79.0% in imatinib and in 88.3% in standard of care (RR 0.91, 95% CI 0.78-1.06). Of the 21 potential long COVID symptoms, patients often reported moderate or major bother from fatigue (24%), sleeping problems (19%) and memory difficulties (17%). We found no convincing difference between imatinib and standard of care groups in quality of life or symptom outcomes. The evidence raises serious doubts regarding the benefit of imatinib in reducing mortality, improving recovery and preventing potential long COVID symptoms when given to patients hospitalised for COVID-19.

Annals of Allergy, Asthma & Immunology

BackgroundGuidance addressing atopic dermatitis (AD) management, last issued in 2012 by the American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force, requires updating as a result of new treatments and improved guideline and evidence synthesis methodology.ObjectiveTo produce evidence-based guidelines that support patients, clinicians, and other decision-makers in the optimal treatment of AD.MethodsA multidisciplinary guideline panel consisting of patients and caregivers, AD experts (dermatology and allergy/immunology), primary care practitioners (family medicine, pediatrics, internal medicine), and allied health professionals (psychology, pharmacy, nursing) convened, prioritized equity, diversity, and inclusiveness, and implemented management strategies to minimize influence of conflicts of interest. The Evidence in Allergy Group …

JAMA

To the Editor Although sometimes considered the pinnacle of scientific evidence, meta-analyses can be problematic. Combining outcomes from heterogeneous trials performed in different settings or populations may give results directly applicable to few. Conclusions are also beholden to methodological design, often discordant from those of subsequent randomized clinical trials. 1 Such may be the case with the recently published dose-response meta-analysis of studies examining efficacy and tolerability of gefapixant for refractory or unexplained chronic cough. 2 Because gefapixant is the first novel efficacious therapy for refractory and unexplained chronic cough, its development involved changes in study design and participant inclusion criteria as well as drug formulation. 3 Four drug formulations were ultimately tested, with maximum bioavailability achieved for the formulation used in the phase 3 trials, such that …

The Lancet

Their stated aim is to summarise the “benefits and harms of weight-lowering drugs”, but the main findings and discussion focus on weight loss, without due consideration to the scarcity of evidence for benefits to health and wellbeing. For instance, quality of life and depression data are reported as low quality or insufficient, and there is no mention of the absence of long-term cardiovascular outcomes. A review on long-term effects of weight-reducing pharmacotherapy included only one trial with cardiovascular outcomes; it found no benefit.

Pilot and Feasibility Studies

BackgroundSeniors with recurrent hospitalizations who are taking multiple medications including high-risk medications are at particular risk for serious adverse medication events. We will assess whether an expert Clinical Pharmacology and Toxicology (CPT) medication management intervention during hospitalization with follow-up post-discharge and communication with circle of care is feasible and can decrease drug therapy problems amongst this group.MethodsThe design is a pragmatic pilot randomized trial with 1:1 patient-level concealed randomization with blinded outcome assessment and data analysis. Participants will be adults 65 years and older admitted to internal medicine services for more than 2 days, who have had at least one other hospitalization in the prior year, taking five or more chronic medications including at least one high-risk medication. The CPT intervention identifies medication targets …

BackgroundThe purpose of this systematic review was to analyze the available literature on fixation of distal radius fractures (DRFs) under wide-awake local anesthesia no-tourniquet (WALANT), and to examine postoperative pain scores and functional outcomes, operative data including operative time and blood loss, and the frequency of adverse events.MethodsEmbase, MEDLINE, Web of Science, and SCOPUS were searched from inception until May 2022 for relevant studies. Studies were screened in duplicate, and data on pain scores, functional outcomes, and adverse events were recorded. Due to methodological and statistical heterogeneity, the results are presented in a descriptive fashion.ResultsTen studies were included comprising 456 patients with closed, unilateral DRFs, of whom 226 underwent fixation under WALANT. These patients had a mean age of 52.8 ± 8.3 years, were 48% female, and had a …

Journal of Critical Care

IntroductionThe objective of this study was to create a definition of patient-important upper gastrointestinal bleeding during critical illness as an outcome for a randomized trial.DesignThis was a sequential mixed-methods qualitative-dominant multi-center study with an instrument-building aim. In semi-structured individual interviews or focus groups we elicited views from survivors of critical illness and family members of patients in the intensive care unit (ICU) regarding which features indicate important gastrointestinal bleeding. Quantitative demographic characteristics were collected. We analyzed qualitative data using inductive content analysis to develop a definition for patient-important upper gastrointestinal bleeding.SettingCanada and the United States.Participants51 ICU survivors and family members of ICU patients.ResultsParticipants considered gastrointestinal bleeding to be important if it resulted in death …

Pilot and Feasibility Studies

Knee arthritis is a leading cause of limited function and long-term disability in older adults. Despite a technically successful total knee arthroplasty (TKA), around 20% of patients continue to have persisting pain with reduced function, and low quality of life. Many of them continue using opioids for pain control, which puts them at risk for potential long-term adverse effects such as dependence, overdose and risk of falls. Although persisting pain and opioid use after TKA have been recognised to be important issues, individual strategies to decrease their burden have limitations and multi-component interventions, despite their potential, have not been well studied. In this study, we propose a multi-component pathway including personalized pain management, facilitated by a pain management coordinator. The objectives of this pilot trial are to evaluate feasibility (recruitment, retention, and adherence), along with opioid-free pain control at 8 weeks after TKA. This is a protocol for a multicentre pilot randomised controlled trial using a 2-arm parallel group design. Adult participants undergoing unilateral total knee arthroplasty will be considered for inclusion and randomised to control and intervention groups. Participants in the intervention group will receive support from a pain management coordinator who will facilitate a multicomponent pain management pathway including (1) preoperative education on pain and opioid use, (2) preoperative risk identification and mitigation, (3) personalized post-discharge analgesic prescriptions and (4) continued support for pain control and recovery up to 8 weeks post-op. Participants in the control group will undergo …

Pilot and Feasibility Studies

BackgroundExtremity fractures are common, and most are managed operatively; however, despite successful reduction, up to half of patients report persistent post-surgical pain. Furthermore, psychological factors such as stress, distress, anxiety, depression, catastrophizing, and fear-avoidance behaviors have been associated with the development of chronic pain. The purpose of this pilot study was to examine the feasibility of a randomized controlled trial to determine the effect of in-person cognitive behavioral therapy (CBT) vs. usual care on persistent post-surgical pain among patients with a surgically managed extremity fracture.MethodsEligible patients were randomized to either in-person CBT or usual care. We used four criteria to judge the composite measure of feasibility: 1) successful implementation of CBT at each clinical site, 2) 40 patients recruited within 6 months, 3) treatment compliance in a minimum …

medRxiv

Falls and hip fractures are a major health concern among older adults in long term care (LTC) with almost 50% of residents experiencing a fall annually. Hip fractures are one of the most important and frequent fall-related injuries in LTC. The purpose of this study was to determine the feasibility (recruitment rate and adaptations) of implementing the PREVENT (Person-centred Routine Fracture PreEVENTion) model in practice, with a subobjective to understand facilitators and barriers. The model includes a multifactorial intervention on diet, exercise, environmental adaptations, hip protectors, medications (including calcium and vitamin D), and medication reviews to treat residents at high risk of fracture. Our secondary outcomes aimed to assess change in knowledge uptake of the guidelines among healthcare providers and in the proportion of fracture prevention prescriptions post-intervention. We conducted a mixed-methods non-experimental design study in three LTC homes across southern Ontario. A local champion was selected to guide the implementation. We reported recruitment rates using descriptive statistics and adaptations using content analysis. We reported changes in knowledge uptake using the paired sample t-test and the percentage of osteoporosis medications prescriptions using absolute change. Within five months, we recruited three LTC homes. We required two months to identify and train the local champion over three 1.5-hour train-the-trainer sessions, and the champion required three months to deliver the intervention to the healthcare team. We identified several facilitators, barriers, and adaptations. Benefits of the model …

Background: Several studies have reported overuse of spinal imaging, which, in Canada, led to several provincial pathways aimed at optimizing use of imaging. We assessed temporal trends in spine imaging in two Canadian provinces.Methods: We explored use of x-ray, computed tomography (CT), and magnetic resonance imaging (MRI) examinations of the cervical, thoracic and lumbar spine regions among adults in Ontario (April 1, 2002 to March 31, 2019) and in Manitoba, Canada (April 1, 2001 to March 31, 2011) using linked Ontario Health Insurance Plan administrative databases and data from Manitoba Health. We calculated the age-and sex-adjusted rates of spinal x-ray, CT and MRI examinations by dividing the number of imaging studies by the population of each province for each year and estimated use of each imaging modality per 100,000 persons.Results: The total cost of spine imaging in Ontario increased from $45.8 million in 2002/03 to $70.3 million in 2018/19 (a 54% increase), and in Manitoba from $2.2 million in 2001/02 to $5 million in 2010/11 (a 127% increase). In Ontario, rates of spine x-rays decreased by 12% and spine CT scans decreased by 28% over this time period, while in Manitoba rates of spine x-rays and CT scans remained constant. Age-and sex-adjusted utilization of spinal MRI scans per 100,000 persons markedly increased over time in both Ontario (277%) and Manitoba (350%).Conclusion: Despite efforts to reduce use of inappropriate spinal imaging, both Ontario and Manitoba have greatly increased utilization of spine MRI in the past two decades.

medRxiv

Introduction Hyperparathyroidism is a common endocrine disorder that can be secondary to a single or multiple abnormal parathyroid glands and can occur in the context of chronic kidney disease (CKD). There are three types of hyperparathyroidism, and all are definitively managed via surgical extirpation of abnormal parathyroid gland tissue. Intraoperative parathyroid hormone (IOPTH) monitoring was introduced over three decades ago and has been shown to improve clinical outcomes in patients with primary hyperparathyroidism (PHPT). As the incidence of PHPT rises due to improving screening globally and the incidence of CKD rises, it will be important to optimize adoption and standardization of IOPTH within endocrine surgery centers around the world. We will perform a cross-sectional survey study of surgeon rationale, operational details, and barriers associated with IOPTH adoption across North America. Methods and analysis We will utilize a convenience sampling technique to distribute an online survey to head and neck surgeons and endocrine surgeons across North America. This survey will be distributed via email to three North American professional societies (i.e., Canadian Society for Otolaryngologists–Head and Neck Surgeons, American Head and Neck Society, and American Association of Endocrine Surgeons). The survey will consist of 30 multiple choice questions that are divided into three concepts: (1) participant demographics and training details, (2) details of surgical adjuncts during parathyroidectomy, and (3) barriers to adoption of IOPTH. Descriptive analyses and multiple logistic regression models will be used to …

Introduction A third of Canadian Armed Forces veterans report difficulty adjusting to post-military life. Moreover, an estimated 40% of Canadian veterans live with chronic pain, which is likely associated with greater needs during the transition from military to civilian life. This review explores challenges and transition needs among military personnel living with chronic pain as they return to civilian life. Methods We searched MEDLINE, EMBASE, CINAHL, Scopus, and Web of Science from inception to July 2022, for qualitative, observational, and mixed-method studies exploring transition needs among military veterans released with chronic pain. Reviewers, working independently and in duplicate, conducted screening and used a standardized and pilot-tested data collection form to extract data from all included studies. Content analysis was used to create a coding template to …

Pediatric Critical Care Medicine

OBJECTIVES:To implement an early rehabilitation bundle in two Canadian PICUs.DESIGN AND SETTING:Implementation study in the PICUs at McMaster Children’s Hospital (site 1) and London Health Sciences (site 2).PATIENTS:All children under 18 years old admitted to the PICU were eligible for the intervention.INTERVENTIONS:A bundle consisting of: 1) analgesia-first sedation; 2) delirium monitoring and prevention; and 3) early mobilization.MEASUREMENTS AND MAIN RESULTS:Primary outcomes were the duration of implementation, bundle compliance, process of care, safety, and the factors influencing implementation. Secondary endpoints were the impact of the bundle on clinical outcomes such as pain, delirium, iatrogenic withdrawal, ventilator-free days, length of stay, and mortality. Implementation occurred over 26 months (August 2018 to October 2020). Data were collected on 1,036 patients …

Intraoperative parathyroid hormone (iPTH) monitoring is standard-of-care in the surgical management of hyperparathyroidism. It involves real-time determination of circulating PTH levels to guide parathyroid gland excision. There exists several iPTH monitoring criteria, such as the Miami criteria, and a lack of standardization in the timing of post-parathyroid gland excision samples. We present a protocol of a systematic review and network meta-analysis of diagnostic test accuracy to identify the iPTH criteria and post-gland excision timepoint that best predicts surgical cure in hyperparathyroidism. The database search strategy will be developed in conjunction with a librarian specialist. We will perform a search of Medline (Ovid), EMBASE (Ovid), CINAHL, Cochrane Collaboration, and Web of Science from 1990-present. Studies will be eligible if they include adult patients diagnosed with hyperparathyroidism who undergo parathyroidectomy with iPTH monitoring. We will only include studies that report diagnostic test properties for iPTH criteria and/or post-excision sampling timepoints. All screening, full-text review, data extraction, and critical appraisal will be performed in duplicate. Critical appraisal will be performed using QUADAS-2 instrument. A descriptive analysis will present study and critical appraisal characteristics. We will perform evaluation of between-study heterogeneity using I 2 and Cochrane Q and where applicable, we will perform sensitivity analysis. Our network metaanalysis will include Bayesian hierarchical framework with random effects using multiple models.Ethics approval is not required. This proposed systematic review will …

BackgroundFindings from randomised controlled trials (RCTs) are synthesised through meta-analyses, which inform evidence-based decision-making. When key details regarding trial outcomes are not fully reported, knowledge synthesis and uptake of findings into clinical practice are impeded.AimsOur study assessed reporting of primary outcomes in RCTs for older adults with major depressive disorder (MDD).MethodTrials published between 2011 and 2021, which assessed any intervention for adults aged ≥65 years with a MDD diagnosis, and that specified a single primary outcome were considered for inclusion in our study. Outcome reporting assessment was conducted independently and in duplicate with a 58-item checklist, used in developing the CONSORT-Outcomes statement, and information in each RCT was scored as ‘fully reported’, ‘partially reported’ or ‘not reported’, as applicable.ResultsThirty-one …

ObjectiveThe objective of this study is to evaluate the comparative benefits and harms of opioids and cannabis for medical use for chronic non-cancer pain.DesignSystematic review and network meta-analysis.Data sourcesEMBASE, MEDLINE, CINAHL, AMED, PsycINFO, PubMed, Web of Science, Cannabis-Med, Epistemonikos and the Cochrane Library (CENTRAL) from inception to March 2021.Study selectionRandomised trials comparing any type of cannabis for medical use or opioids, against each other or placebo, with patient follow-up ≥4 weeks.Data extraction and synthesisPaired reviewers independently extracted data. We used Bayesian random-effects network meta-analyses to summarise the evidence and the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach to evaluate the certainty of evidence and communicate our findings.ResultsNinety trials involving …

Plos one

1. Lee A, McArthur C, Ioannidis G, Mayhew A, Adachi JD, Griffith LE, et al.(2023) Associations between Social Isolation Index and changes in grip strength, gait speed, bone mineral density (BMD), and selfreported incident fractures among older adults: Results from the Canadian Longitudinal Study on Aging (CLSA). PLoS ONE 18 (10): e0292788. https://doi. org/10.1371/journal. pone. 0292788 PMID: 37851659

Journal of Clinical Epidemiology

ObjectivesTo make recommendations regarding factors that affect COVID-19 vaccine uptake by ethnic minority individuals in the United Kingdom, together with strategies that could be used to increase uptake.Study Design and SettingThe results of two rapid systematic reviews—one identifying factors that affect respiratory vaccine uptake in ethnic minority adults and the other identifying experimental evaluations of strategies to increase vaccine uptake in ethnic minority adults—were put into Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Evidence to Decision frameworks to support discussion with a panel of ethnic minority community organizations, community-focused small companies, and academics of the relevance of the review findings to the UK COVID context. Aided by the frameworks, the panel made recommendations for factors that need to be addressed to increase …

Journal of Clinical Epidemiology

ObjectivesIn rheumatology, there is a clinical need to identify patients at high risk (>50%) of not responding to the first-line therapy methotrexate (MTX) due to lack of disease control or discontinuation due to adverse events (AEs). Despite this need, previous prediction models in this context are at high risk of bias and ignore AEs. Our objectives were to (i) develop a multinomial model for outcomes of low disease activity and discontinuing due to AEs 6 months after starting MTX, (ii) update prognosis 3-month following treatment initiation, and (iii) externally validate these models.Study Design and SettingA multinomial model for low disease activity (submodel 1) and discontinuing due to AEs (submodel 2) was developed using data from the UK Rheumatoid Arthritis Medication Study, updated using landmarking analysis, internally validated using bootstrapping, and externally validated in the Norwegian Disease …

Journal of Clinical Epidemiology

ObjectiveTo apply a hierarchical model (HM) that addresses measurement error in regression of the treatment effect on the control group event rate (CR). We compare HM to weighted linear regression (WLR) which is subject to measurement error and mathematical coupling.Study design and settingWe reviewed published hierarchical models that address measurement error and implemented a Bayesian version in open-source code to facilitate adoption by meta-analysts. We compared WLR and HM across a very large convenience sample of meta-analyses published in the Cochrane Database of Systematic Reviews.ResultsWe applied both approaches (WLR and a HM that addresses measurement error) to 3,193 meta-analyses that included 33,071 studies (average 10.28 studies per meta-analysis). A statistically significant slope suggesting an association between the treatment effect and CR was demonstrated …

Journal of Clinical Epidemiology

ObjectivesData-driven decision support tools have been increasingly recognized to transform health care. However, such tools are often developed on predefined research datasets without adequate knowledge of the origin of this data and how it was selected. How a dataset is extracted from a clinical database can profoundly impact the validity, interpretability and interoperability of the dataset, and downstream analyses, yet is rarely reported. Therefore, we present a case study illustrating how a definitive patient list was extracted from a clinical source database and how this can be reported.Study Design and SettingA single-center observational study was performed at an academic hospital in the Netherlands to illustrate the impact of selecting a definitive patient list for research from a clinical source database, and the importance of documenting this process. All admissions from the critical care database admitted …

Journal of clinical epidemiology

ObjectivesTo make informed decisions, the general population should have access to accessible and understandable health recommendations. To compare understanding, accessibility, usability, satisfaction, intention to implement, and preference of adults provided with a digital “Plain Language Recommendation” (PLR) format vs. the original “Standard Language Version” (SLV).Study Design and SettingAn allocation-concealed, blinded, controlled superiority trial and a qualitative study to understand participant preferences. An international on-line survey. 488 adults with some English proficiency. 67.8% of participants identified as female, 62.3% were from the Americas, 70.1% identified as white, 32.2% had a bachelor's degree as their highest completed education, and 42% said they were very comfortable reading health information. In collaboration with patient partners, advisors, and the Cochrane Consumer …

Journal of Clinical Epidemiology

ObjectivesClinical study reports (CSRs) are highly detailed documents that play a pivotal role in medicine approval processes. Though not historically publicly available, in recent years, major entities including the European Medicines Agency (EMA), Health Canada, and the US Food and Drug Administration (FDA) have highlighted the importance of CSR accessibility. The primary objective herein was to determine the proportion of CSRs that support medicine approvals available for public download as well as the proportion eligible for independent researcher request via the study sponsor.Study Design and SettingThis cross-sectional study examined the accessibility of CSRs from industry-sponsored clinical trials whose results were reported in the FDA-authorized drug labels of the top 30 highest-revenue medicines of 2021. We determined (1) whether the CSRs were available for download from a public …

Journal of Clinical Epidemiology

ObjectivesA core outcome set (COS) is an agreed standardized set of outcomes that should be measured and reported, as a minimum, in specific areas of health or health care. A COS is developed through a consensus process to ensure health care outcomes to be measured are relevant to decision-makers, including patients and health-care professionals. Use of COS in guideline development is likely to increase the relevance of the guideline to those decision-makers. Previous work has looked at the uptake of COS in trials, systematic reviews, health technology assessments and regulatory guidance but to date there has been no evaluation of the use of COS in practice guideline development. The objective of this study was to investigate the representation of core outcomes in a set of international practice guidelines.Study Design and SettingWe searched for clinical guidelines relevant to ten high-quality COS …

Journal of Clinical Epidemiology

ObjectivesClinical study reports (CSRs) are highly detailed documents that play a pivotal role in medicine approval processes. Though not historically publicly available, in recent years, major entities including the European Medicines Agency (EMA), Health Canada, and the US Food and Drug Administration (FDA) have highlighted the importance of CSR accessibility. The primary objective herein was to determine the proportion of CSRs that support medicine approvals available for public download as well as the proportion eligible for independent researcher request via the study sponsor.Study Design and SettingThis cross-sectional study examined the accessibility of CSRs from industry-sponsored clinical trials whose results were reported in the FDA-authorized drug labels of the top 30 highest-revenue medicines of 2021. We determined (1) whether the CSRs were available for download from a public …

Journal of Clinical Epidemiology

Journal Pre-proof Response to †œReporting of Health Equity Considerations in Vaccine Trials for COVID-19: Comment†Roger Kou, Lawrence Mbuagbaw PII: S0895-4356 (24) 00129-X DOI: https://doi. org/10.1016/j. jclinepi. 2024.111374 Reference: JCE 111374 To appear in: Journal of Clinical Epidemiology Received Date: 15 April 2024 Revised Date: 23 April 2024 Accepted Date: 24 April 2024 Please cite this article as: Kou R, Mbuagbaw L, Response to †œReporting of Health Equity Considerations in Vaccine Trials for COVID-19: Comment†, Journal of Clinical Epidemiology (2024), doi: https://doi. org/10.1016/j. jclinepi. 2024.111374. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting …

Journal of Clinical Epidemiology

ObjectivesTo estimate the frequency and critically appraise the use and reporting of composite outcomes in randomized clinical trials on pharmacological interventions for coronary artery disease.Study Design and SettingA metaresearch study. A search strategy was developed to retrieve references from MEDLINE. We considered articles, published from 1st January 2020, to December 31, 2021, reporting results of clinical primary outcomes from randomized clinical trials which assessed pharmacological interventions, used alone or in combination, for the treatment or secondary prevention (previous coronary event) of coronary artery disease.ResultsFrom the 34 included studies, 28 (82.35%) had a primary composite outcome. Thirteen unique composite primary outcomes were used with the most frequent being "cardiovascular death, myocardial infarction, stroke" (12/28, 42.86%). The term major adverse cardiac …

Journal of Clinical Epidemiology

ObjectivesThis article describes considerations for addressing intransitivity when assessing the certainty of the evidence from network meta-analysis (NMA) using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Intransitivity is induced by effect modification, that is, when the magnitude of the effect between an intervention and outcome differs depending on the level of another factor.Study Design and SettingTo develop this GRADE concept paper, the lead authors conducted iterative discussions, computer simulations, and presentations to the GRADE project group and at GRADE working group meetings. The GRADE Working Group formally approved the article in July 2022.ResultsNMA authors can have a higher or a lower threshold to rate down the certainty of the evidence due to intransitivity, which depends on the extent of their concerns regarding the …

Journal of clinical epidemiology

Scoping reviews can identify a large number of evidence sources. This commentary describes and provides guidance on planning, conducting, and reporting large scoping reviews.This guidance is informed by experts in scoping review methodology, including JBI Scoping Review Methodology group members, who have also conducted and reported large scoping reviews.We propose a working definition for large scoping reviews that includes approximately 100 sources of evidence but must also consider the volume of data to be extracted, the complexity of the analyses and purpose. We pose six core questions for scoping review authors to consider when planning, developing, conducting, and reporting large scoping reviews. By considering and addressing these questions, scoping review authors might better streamline and manage the conduct and reporting of large scoping reviews from the planning to …

Journal of Clinical Epidemiology

ObjectivesClinical study reports (CSRs) are highly detailed documents that play a pivotal role in medicine approval processes. Though not historically publicly available, in recent years, major entities including the European Medicines Agency (EMA), Health Canada, and the US Food and Drug Administration (FDA) have highlighted the importance of CSR accessibility. The primary objective herein was to determine the proportion of CSRs that support medicine approvals available for public download as well as the proportion eligible for independent researcher request via the study sponsor.Study Design and SettingThis cross-sectional study examined the accessibility of CSRs from industry-sponsored clinical trials whose results were reported in the FDA-authorized drug labels of the top 30 highest-revenue medicines of 2021. We determined (1) whether the CSRs were available for download from a public …

Journal of Clinical Epidemiology

ObjectivesThe Australian National COVID-19 Clinical Evidence Taskforce has been developing, maintaining, and disseminating living guidelines and decision support tools (clinical flowcharts) for the care of people with suspected or confirmed COVID-19 since 2020. Living guidelines, a form of living evidence, are a relatively new approach; hence, more work is required to determine how to optimize their use to inform practice, policy, and decision-making and to explore implementation, uptake, and impact implications. An update of an earlier impact evaluation was conducted to understand sustained awareness and use of the guidelines; the factors that facilitate the widespread adoption of the guidelines and to explore the perceived strengths and opportunities for improvement of the guidelines.Study Design and SettingA mixed-methods impact evaluation was conducted. Surveys collected both quantitative and …

Journal of Clinical Epidemiology

ObjectiveIn this study we evaluate how to estimate diagnostic test accuracy (DTA) correctly in the presence of longitudinal patient data (i.e., repeated test applications per patient).Study design and SettingWe used a nonparametric approach to estimate sensitivity and specificity of three tests for different target conditions with varying characteristics (i.e., episode length and disease-free intervals between episodes): 1) systemic inflammatory response syndrome (n = 36), 2) depression (n = 33), and 3) epilepsy (n = 30). DTA was estimated on the levels ‘time’, ‘block’, and ‘patient-time’ for each diagnosis, representing different research questions. The estimation was conducted for the time units per minute, per hour, and per day.ResultsA comparison of DTA per and across use cases showed variations in the estimates, which resulted from the used level, the time unit, the resulting number of observations per patient, and …

Journal of Clinical Epidemiology

ObjectivesRandomized controlled trials (RCTs) with repeatedly measured continuous variables as primary outcomes are common. Although statistical methodologies for calculating sample sizes in such trials have been extensively investigated, their practical application remains unclear. This study aims to provide an overview of sample size calculation methods for different research questions (e.g., key time point treatment effect, treatment effect change over time) and evaluate the adequacy of current practices in trial design.Study Design and SettingWe conducted a comprehensive search of PubMed to identify RCTs published in core journals in 2019 that utilized repeatedly measured continuous variables as their primary outcomes. Data were extracted using a predefined questionnaire including general study characteristics, primary outcomes, detailed sample size calculation methods, and methods for analyzing …

Journal of Clinical Epidemiology

ObjectiveTo provide equipercentile equating of physical function (PF) scores from frequently used patient-reported outcome measures (PROMs) in cancer patients to facilitate data pooling and comparisons.Study Design and SettingAdult cancer patients from five European countries completed the European Organization for Research and Treatment of Cancer (EORTC) computer adaptive test (CAT) Core, EORTC Quality of Life Questionnaire Version 3.0 (QLQ-C30), Functional Assessment of Cancer Therapy - General (FACT-G), 36-item Short Form Health Survey (SF-36), and the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 20a short form. The R package “equate” was used to establish conversion tables of PF scores on those measures with a bivariate rank correlation of at least 0.75.ResultsIn total, 953 patients with cancer (mean age 58.9 years, 54.7% men …

Journal of clinical epidemiology

ObjectivesTo make informed decisions, the general population should have access to accessible and understandable health recommendations. To compare understanding, accessibility, usability, satisfaction, intention to implement, and preference of adults provided with a digital “Plain Language Recommendation” (PLR) format vs. the original “Standard Language Version” (SLV).Study Design and SettingAn allocation-concealed, blinded, controlled superiority trial and a qualitative study to understand participant preferences. An international on-line survey. 488 adults with some English proficiency. 67.8% of participants identified as female, 62.3% were from the Americas, 70.1% identified as white, 32.2% had a bachelor's degree as their highest completed education, and 42% said they were very comfortable reading health information. In collaboration with patient partners, advisors, and the Cochrane Consumer …

Journal of Clinical Epidemiology

ObjectivesTo determine the measurement properties of PaRental Experience with care for Children with serIOUS illnesses (PRECIOUS), a parent-reported measure of Quality of Care for seriously ill children across care settings and illness trajectories.Study Design and SettingParents self-administered baseline and 2-week follow-up surveys online. Exploratory Factor Analysis was used to determine PRECIOUS’s factor structure and select items. Internal consistency was evaluated with Cronbach’s α, test-retest reliability with intraclass correlation coefficients, and convergent validity with Spearman’s correlations between PRECIOUS scales and subscales of Measure of Processes of Care and Quality of Children’s Palliative Care Instrument.ResultsOf 152 parents [108 (71%) mothers, 44 (29%) fathers] who completed the baseline survey, 123 (81%) completed follow-up. Exploratory Factor Analysis grouped PRECIOUS …

Journal of Clinical Epidemiology

In 2021, Moher published a paper in the Journal of Clinical Epidemiology highlighting important gaps in the research scholarship ecosystem [1]. One such gap was in open science, which is defined as ‘‘the potential of making the scientific process more transparent, inclusive and democratic’’according to the United Nations Educational, Scientific and Cultural Organization (UNESCO)[2]. The Transparency and Openness Promotions (TOP) guidelines were developed to create a more open research culture and improve open science practices [3]. Based on the TOP guidelines, the Center for Open Science developed the TOP Factor for journals. The TOP Factor provides a mechanism to assess and compare the degree that journals comply with the TOP guidelines, and open science practices more broadly. In his 2021 article, Moher commented that the Journal of Clinical Epidemiology had a TOP Factor of 1 [1].Open …