Evidence-based social sciences in China: introduction to a special collection
At a conference on impact evaluation in January 2008, one of the opening speakers commented that we should not overstate the importance of studies of effectiveness in policy. They hadn't, for example, played a role in China's success. But a presentation shortly after challenged that view. When China began opening the economy in the mid-70s, it did so through experimentation. Whilst not organized as randomized controlled trials, the government tried out different incentive systems for farmers, firms and workers and learned from the results. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - October 23, 2021 Category: Epidemiology Authors: Howard White Source Type: research

The Fragility Index Should Not Be Used For Sample Size Calculations in Clinical Trials.
Baer et al. recommend accounting for potentially “fragile” results when calculating a trial's sample size.1 “Fragility” is defined by the fragility index (FI), calculated as the minimum number of swaps from non-event to event in the treatment arm needed to undo the significance of a trial, with smaller FI values representing higher fragili ty. The FI lacks a theoretical basis and promotes an incorrect intuition of probability, leading users to make the wrong decision. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - October 21, 2021 Category: Epidemiology Authors: Gail E Potter Source Type: research


Dear Sir, (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - October 20, 2021 Category: Epidemiology Authors: Dr Jos Verbeek, Sharea Ijaz, Christina Tikka, Julitta Boschman, Jan Hoving Source Type: research

Evidence Based Social Science in China Paper 1: The History and Development of Evidence Based Social Work in China
With the rise of the "New Public Management" movement in China, decision makers and public service providers are often required to do performance evaluations of public expenditures [1]. This crisis in what would be demanded of social workers in China parallels the theory offered by Okpych and Yu [2] as the prompt for new paradigms. Social work professionals in China realized that to guarantee their professional status, they must provide expert and effective services for their clients [2]. This governmental expectation in China corresponds to the Government Performance and Results Act of 1993 in the United States....
Source: Journal of Clinical Epidemiology - October 17, 2021 Category: Epidemiology Authors: Zheng-Gang Bai, Rui-Hai Bai, Jia-Yu Duan, Mi-Na Liu, Weng-Jing Jin, Iris Chi Source Type: research

Resource use during systematic review production varies widely: a scoping review: authors ’ reply
In their letter to the editor regarding our publication “Resource use during systematic review production varies widely: a scoping review” [1], Morales-Plaza et al. make an important point about socioeconomic difficulties that are relevant limitations of systematic review (SR) production. We find the issue very important. However, as our scoping revi ew shows such barriers exists even in high- and middle-income countries [2], we therefore fully acknowledge the challenges authors of SRs face anywhere. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - October 16, 2021 Category: Epidemiology Authors: Nussbaumer-Streit B, Ziganshina LE, Mahmi ć-Kaknjo M, Gartlehner G, Sfetcu R, Lund H Source Type: research

Resource use during systematic review production varies widely: a scoping review: response to Nussbaumer-Streit et al.
We have read the recent article by Nussbaumer-Streit et al. [1] about mapping the use of resources during the production of systematic reviews (SRs) and why some steps of its production consume many resources. It is gratifying that expert methodologists are interested in identifying these knowledge gaps and helping to improve the efficiency of SR production. However, we are encouraged to make some observations that were not discussed in the review and consider them relevant when mapping resources during SR production. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - October 16, 2021 Category: Epidemiology Authors: Cristhian D. Morales-Plaza, David A. Forero-Pe ña, Fhabián S. Carrión-Nessi Source Type: research

Evidence Based Social Science in China Paper 3: The quality of social science systematic reviews and meta-analysis published from 2000-2019
Systematic reviews (SR) adopt a comprehensive method to search, collect, select, evaluate and synthesize all high-quality research evidence in related fields for a specific research problem. SRs should have key features, including developing a detailed search strategy and systematic coding, analysis and reporting. Systematic reviews also assess the confidence we can have in the findings of a study through critical appraisal or quality assessment [1]. Quality assessment is the grading of the research quality according to pre-established criteria. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - October 15, 2021 Category: Epidemiology Authors: Zheng-Gang Bai, Qiang Bing, Rong-Rong Gong, Ru-Hai Bai, Yang Zhoua Source Type: research

The inclusion of outcomes in search strategies for Cochrane Reviews: authors ’ reply
We thank Verbeek et al. for their thoughtful comments on our research on the proportion of Cochrane reviews including outcomes in their literature search and the potential effect on the findings [1]. Verbeek et al studied how outcomes in Cochrane reviews were defined and used [2]. However, it is unclear how they judged if the review included the terms related to the outcomes in the search strategy (e.g., how they treated those reviews that did not reported search strategies, which accounted for approximately 15% of the recent Cochrane reviews [1]) as the focus of their paper and therefore much of the explanations of their ...
Source: Journal of Clinical Epidemiology - October 14, 2021 Category: Epidemiology Authors: Yasushi Tsujimoto, Yusuke Tsutsumi, Yuki Kataoka, Masahiro Banno, Toshi A. Furukawa Source Type: research

Regression discontinuity analysis for pharmacovigilance: statin example reflected trial findings showing little evidence of harm
Randomised controlled trials (RCTs) are top of the hierarchy of evidence [1], but may not be generalisable (strict eligibility criteria) or possible (ethical issues, low power for rare conditions), and are expensive, time consuming, and often short follow-up [2,3]. Using observational data addresses some issues, but is subject to unmeasured confounding. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - October 11, 2021 Category: Epidemiology Authors: Lauren Scott, Maria Theresa Redaniel, Matthew Booker, Rupert A. Payne, Kate Tilling Tags: Original Research Source Type: research

Estimating Power for Clinical Trials with Patient Reported Outcomes - using Item Response Theory
Patient reported outcomes (PRO) are variables reflecting the status of a patient's health condition whose values come directly from the patients [1]. PROs differ from other health outcomes because these patient's characteristics cannot be directly observed and are often measured using self-reported questionnaires with Likert-scale responses. For example, a patient's depression can be measured with questions like: “In the past 7 days I felt hopeless” with responses of “Never, Rarely, Sometimes, Often, and Always”. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - October 11, 2021 Category: Epidemiology Authors: Jinxiang Hu, Jeffrey Thompson, Dinesh Pal Mudaranthakam, Lynn Chollet Hinton, David Streeter, Michele Park, Berend Terluin, Byron Gajewski Tags: Original Article Source Type: research

Patient-important Outcomes
Five articles in this issue highlight patient outcome issues. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - October 9, 2021 Category: Epidemiology Tags: Editorial Source Type: research

More work needed on decision analysis for shared decision-making: a scoping review
The clinical encounter requires regular and continuous decision-making.1 Decision-making can be defined as a cognitive process that involves the selection of a course of action among several alternative possibilities.2 In the clinical context, decisions can relate to a range of actions, including diagnostic tests, treatments or referrals.3 Clinical decisions should ideally incorporate the best available evidence in light of the medical characteristics and the preferences of each patient.4 (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - October 7, 2021 Category: Epidemiology Authors: Brittany Humphries, Montserrat Le ón-García, Ena Niño de Guzman Quispe, Carlos Canelo-Aybar, Claudia Valli, Kevin Pacheco Barrios, Arnav Agarwal, Susan Mirabi, Mark H. Eckman, Gordon Guyatt, Shannon M. Bates, Pablo Alonso-Coello, Feng Xie Source Type: research

Key concepts in clinical epidemiology: addressing and reporting sources of bias in randomised controlled trials
Randomised controlled trials are widely considered the most robust design for evaluating the effects of clinical interventions. While generalisability is often limited, randomisation aims to ensure that effects observed are genuine. However, there are common sources of bias, even in well-conducted trials, that pose a threat to this interpretation. The revised Cochrane risk-of-bias tool for trials (RoB 2) distinguishes five domains of bias that can affect the results of trials stemming from (1) the randomisation process, (2) deviations from intended interventions, (3) missing outcome data, (4) outcome measurement, and (5) r...
Source: Journal of Clinical Epidemiology - September 24, 2021 Category: Epidemiology Authors: Daniel Kotz, Robert West Source Type: research

A taxonomy and framework for identifying and developing actionable statements in guidelines suggests avoiding informal recommendations
Guideline recommendations are explicit actionable statements that suggest a choice from alternative options to optimize desirable consequences of these options and include elements of the population, interventions and comparators from the question they address. (1-4) Formal recommendations should be based on the best available evidence and developed according to trustworthy and transparent methods and standards.(4-9) These methods include concepts such as the systematic and transparent consideration of the certainty of the evidence and determining the strength of the recommendation based on explicit judgments of a guidelin...
Source: Journal of Clinical Epidemiology - September 22, 2021 Category: Epidemiology Authors: Tamara Lotfi, Anisa Hajizadeh, Lorenzo Moja, Elie A. Akl, Thomas Piggott, Tamara Kredo, Miranda W Langendam, Alfonso Iorio, Miloslav Klugar, Jitka Klugarov á, Ignacio Neumann, Wojtek Wiercioch, Grigorios I. Leontiadis, Lawrence Mbuagbaw, Alexis F. Turgeo Source Type: research

Commentary on Controversy and Debate 4 paper series: Questionable utility of the relative risk in clinical research
This Controversy and Debate series by Doi and Chu and their respective colleagues clearly demonstrates that the tale of our two most fundamental effect measures, the relative risk (RR) and odds ratio (OR), is alive and well. Through this series of four papers, they use probabilistic and statistical methods to present their point of view, and illustrate these points using a resource which has been likened to the health services equivalent of the Human Genome Project [Naylor CD. Grey zones of clinical practice: some limits to evidence-based medicine. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 21, 2021 Category: Epidemiology Authors: George A. Wells Source Type: research

Causal analyses of existing databases: The importance of understanding what can be achieved with your data before analysis (commentary on Hern án)
Hern án's short communication provocatively argues that power calculations should not be required for causal analyses of existing databases[1]. His view is thought- provoking and helpful: contrasting it with the opposite extreme helps us to con- sider where we might sit between the two. We agree with ma ny of Hernán's points. However, the proposal that, regardless of sample size, available data should be anal- ysed because results can be synthesised in later meta-analyses seems to depend on a scientific utopia that does not re2ect reality. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 21, 2021 Category: Epidemiology Authors: Tim P. Morris, Maarten van Smeden Source Type: research

A few panel members dominated guideline development meeting discussions: A social network analysis
Objectives: To identify patterns of interactions that may influence guideline panels ’ decision-making.Study Design and Setting: Social network analysis (SNA) to describe the conversation network in a guideline development meeting in United States.Results: We analyzed one two-day guideline panel meeting that included 20 members who developed a guideline using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. The conversation pattern of the guideline panel indicated a well-connected network (density=0.59, clustering coefficient=0.82). (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 20, 2021 Category: Epidemiology Authors: Shelly-Anne Li, Reza Yousefi-Nooraie, Gordon Guyatt, Gaurav Talwar, Qi Wang, Ying Zhu, Iztok Hozo, Benjamin Djulbegovic Source Type: research

A few panel members dominated guideline development meeting disucssions: A social network analysis
Objectives: To identify patterns of interactions that may influence guideline panels ’ decision-making.Study Design and Setting: Social network analysis (SNA) to describe the conversation network in a guideline development meeting in United States.Results: We analyzed one two-day guideline panel meeting that included 20 members who developed a guideline using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. The conversation pattern of the guideline panel indicated a well-connected network (density=0.59, clustering coefficient=0.82). (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 20, 2021 Category: Epidemiology Authors: Shelly-Anne Li, Reza Yousefi-Nooraie, Gordon Guyatt, Gaurav Talwar, Qi Wang, Ying Zhu, Iztok Hozo, Benjamin Djulbegovic Source Type: research

Secondary electronic sources demonstrated very good sensitivity for identifying studies evaluating interventions for COVID-19.
: To assess the sensitivity of two secondary electronic sources of COVID-19 studies: 1) the Cochrane COVID-19 Study Register (https://covid-19.cochrane.org/); and, 2) the Living Overview of the Evidence (L •OVE) COVID-19 platform (https://iloveevidence.com/). (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 20, 2021 Category: Epidemiology Authors: O Pierre, C Riveros, S Charpy, I Boutron Source Type: research

Response to “Should We Formalise the Assessment of Clinical Heterogeneity/Diversity In Systematic Reviews” - clarifications of the use of the CDIM tool to assess clinical heterogeneity/diversity in meta-analyses
We would like to commend you for drawing attention to our recently published paper A new tool to assess Clinical Diversity In Meta-analyses (CDIM) of interventions [1,2]. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 19, 2021 Category: Epidemiology Authors: Marija Barbateskovic, J ørn Wetterslev Tags: Letter to the editor Source Type: research

Sample size considerations are needed for the causal analyses of existing databases
Hern án provides reasonable arguments against power calculations for the causal analyses of existing databases, and concluded “In summary, for an important causal question, analyze your data no matter how imprecise you expect your estimate to be, publish your estimate, encourage others to do the same, and then meta-analyze.” [1]. However, the arguments of the paper do not eliminate the need to consider sample size: First, ratio measures such as risk ratios, odds ratios, and rate ratios estimated from small-sample observational studies may suffer from sparse-data bias [2], which carries over th e pooled e...
Source: Journal of Clinical Epidemiology - September 19, 2021 Category: Epidemiology Authors: Mohammad Ali Mansournia Tags: Letter to the editor Source Type: research

A new phenomenon in medical publishing: the autonomous citation
It is common today for medical (and other) researchers to deposit electronic records and copies of their publications on internet databases such as ResearchGate (www.researchgate.net) and Google Scholar (scholar.google.co.nz). These sources serve to make scientific articles widely available and alert depositors when new citations of their published work appear in other articles. Over the last year one of us (GKC) has become aware that not all such citations are what they seem. These have been discovered during a routine check of new citations appearing on a personal ResearchGate webpage. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 19, 2021 Category: Epidemiology Authors: Geoffrey K. Chambers, Ben W. Mol Tags: Letter to the editor Source Type: research

Letter to the editor: Sample size considerations are needed for the causal analyses of existing databases
Hern án provides reasonable arguments against power calculations for the causal analyses of existing databases, and concluded “In summary, for an important causal question, analyze your data no matter how imprecise you expect your estimate to be, publish your estimate, encourage others to do the same, and then meta-analyze.” [1]. However, the arguments of the paper do not eliminate the need to consider sample size: First, ratio measures such as risk ratios, odds ratios, and rate ratios estimated from small-sample observational studies may suffer from sparse-data bias [2], which carries over th e pooled e...
Source: Journal of Clinical Epidemiology - September 19, 2021 Category: Epidemiology Authors: Mohammad Ali Mansournia Source Type: research

Letter to the Editor: Response to “Should We Formalise the Assessment of Clinical Heterogeneity /Diversity In Systematic Reviews” - Clarifications of the use of the CDIM tool to assess clinical heterogeneity/diversity in meta-analyses
We would like to commend you for drawing attention to our recently published paper A new tool to assess Clinical Diversity In Meta-analyses (CDIM) of interventions [1,2]. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 19, 2021 Category: Epidemiology Authors: Marija Barbateskovic, J ørn Wetterslev Source Type: research

Letter to the Editor: A new phenomenon in medical publishing: The autonomous citation
It is common today for medical (and other) researchers to deposit electronic records and copies of their publications on internet databases such as ResearchGate (www.researchgate.net) and Google Scholar (scholar.google.co.nz). These sources serve to make scientific articles widely available and alert depositors when new citations of their published work appear in other articles. Over the last year one of us (GKC) has become aware that not all such citations are what they seem. These have been discovered during a routine check of new citations appearing on a personal ResearchGate webpage. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 19, 2021 Category: Epidemiology Authors: Geoffrey K. Chambers, Ben W. Mol Source Type: research

Specific body mass index trajectories were related to musculoskeletal pain and mortality: 19-year follow-up cohort
What is new? (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 16, 2021 Category: Epidemiology Authors: Maja R. Radoj čić, Romain S. Perera, Lingxiao Chen, Tim D. Spector, Deborah J. Hart, Manuela L. Ferreira, Nigel K. Arden Source Type: research

Reliability of the revised Cochrane risk-of-bias tool for randomised trials (RoB2) improved with the use of implementation instruction
to assess the inter-rater reliability (IRR) of the revised Cochrane risk-of-bias tool for randomised trials (RoB2). (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 16, 2021 Category: Epidemiology Authors: Silvia Minozzi, Kerry Dwan, Francesca Borrelli, Graziella Filippini Source Type: research

Focus groups and interviews with the public led to the development of a template for a GRADE plain language recommendation
The COVID-19 pandemic has without doubt demonstrated that clear communication of health care recommendations to the public is essential. Clear communication can include translating recommendations for the public, articulating risks and benefits, and conveying the certainty of the evidence that informs a recommended action. Recommendations typically come packaged in guidelines and, unfortunately, awareness of guidelines among the general public is limited[1], which is expected as they are generally targeted to clinicians. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 14, 2021 Category: Epidemiology Authors: Nancy Santesso, Wojtek Wiercioch, Angela M. Barbara, Helena Dietl, Holger J. Sch ünemann Source Type: research

Reporting Transparency and Completeness in Trials: Paper 1: Introduction - Better reporting for disruptive clinical trials using routinely collected data
In 2013, Lauer and D'Agostino wrote that “the randomized registry trial represents a disruptive technology, a technology that transforms existing standards, procedures, and cost structures" [1]. Indeed, numerous examples since then have shown that randomized clinical trials using routinely collected data (RCD-RCTs) or data from cohorts c an provide insights that were previously possible only at great expense, if at all [2,3]. Routinely collected data (RCD; e.g., from registries, electronic health records, or administrative databases) are data that are typically collected for purposes other than research via esta...
Source: Journal of Clinical Epidemiology - September 12, 2021 Category: Epidemiology Authors: Lars G. Hemkens, Edmund Juszczak, Brett D. Thombs Tags: Editorial Source Type: research

Reporting Transparency and Completeness in Trials: Paper 4 - Reporting of randomised controlled trials conducted using routinely collected electronic records – room for improvement
Electronic health records (EHR) are digital versions of medical records. Their primary use is clinical documentation of a patient's medical history (1). These data are collected prospectively and can provide a comprehensive longitudinal record of a patient's health. The availability of sequential electronic records provides an opportunity for the secondary use of these data for research purposes. EHR data have been widely used for observational studies and are increasingly being used in randomised controlled trials (RCTs) (2). (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 12, 2021 Category: Epidemiology Authors: Stephen J. McCall, Mahrukh Imran, Lars G. Hemkens, Kimberly Mc Cord, Linda Kwakkenbos, Margaret Sampson, Sena Jawad, Merrick Zwarenstein, Clare Relton, Sin éad M. Langan, David Moher, Ole Fröbert, Brett D. Thombs, Chris Gale, Edmund Juszczak Source Type: research

Reporting Transparency and Completeness in Trials: Paper 2 - Reporting of randomised trials using registries was often inadequate and hindered the interpretation of results
Registries are repositories of health information with those registered sharing a common characteristic, such as a disease, a drug treatment or health exposure1. They can be used to monitor the progression of a health condition and are often utilized to explore etiology, progression and potential treatments or cures of diseases and adherence to treatment guidelines. Registries are a type of routinely collected data that are increasingly utilized as a framework to support randomised controlled trials (RCTs)2 –4. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 12, 2021 Category: Epidemiology Authors: Kimberly A. Mc Cord, Mahrukh Imran, Danielle B. Rice, Stephen J. McCall, Linda Kwakkenbos, Margaret Sampson, Ole Fr öbert, Chris Gale, Sinéad M. Langan, David Moher, Clare Relton, Merrick Zwarenstein, Edmund Juszczak, Brett D. Thombs, CONSORT Extension Source Type: research

Methodological challenges for living systematic reviews conducted during the COVID-19 pandemic: a concept paper
Background: A living systematic review (LSR) is an emerging review type that makes use of continual updating. In the COVID-19 pandemic, we were confronted with a shifting epidemiological landscape, clinical uncertainties and evolving evidence. These unexpected challenges compelled us to amend standard LSR methodology.Objective and outline: Our primary objective is to discuss some challenges faced when conducting LSRs in the context of the COVID-19 pandemic, and to provide methodological guidance for others doing similar work. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 12, 2021 Category: Epidemiology Authors: Claire Iannizzi, Elena Dorando, Jacob Burns, Stephanie Weibel, Clare Dooley, Helen Wakeford, Lise J Estcourt, Nicole Skoetz, Vanessa Piechotta Source Type: research

Evidence Based Social Science in China Paper 2: The quality of social science RCTs published from 2000-2020
This study collected randomized controlled trials (RCTs) published in the social sciences in China and assessed their risk of bias and reporting quality. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 11, 2021 Category: Epidemiology Authors: Xiuxia Li, Yanfei Li, Kangle Guo, Nan Chen, Xudong Cui, Yaolong Chen, Kehu Yang Source Type: research

Why methods matter in a meta-analysis: a reappraisal showed inconclusive injury preventive effect of Nordic hamstring exercise
Injury prevention strategies have been investigated for decades by international sports organizations and research groups.1 Among these prevention strategies, the use of the so-called Nordic hamstring exercise (NHE) is widely considered an established and evidence-based prevention method to reduce hamstring muscle injury risk. For example, findings from a recent Delphi survey involving practitioners from top professional European soccer clubs indicated NHE is considered one of the two most effective muscle injury prevention strategies. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 11, 2021 Category: Epidemiology Authors: Franco M. Impellizzeri, Alan McCall, Maarten van Smeden Source Type: research

Missing data was handled inconsistently in UK prediction models: a review of method used
Clinical prediction models (CPMs) are statistical models or algorithms that use a set of predictor variables to calculate an individual's chance of developing or having a certain condition, and thus aid clinicians with the associated clinical reasoning and decision-making1. Three major phases can be identified in the CPM pipeline: (i) developing and internally validating a CPM; (ii) validating the model on new independent cohorts of patients (external validation), potentially adjusting or updating the model as needed; and (iii) implementing the model in clinical practice while monitoring its impacts2. (Source: Journal of C...
Source: Journal of Clinical Epidemiology - September 11, 2021 Category: Epidemiology Authors: Antonia Tsvetanova, Matthew Sperrin, Niels Peek, Iain Buchan, Stephanie Hyland, Glen P. Martin Source Type: research

Reporting transparency and completeness in trials: Paper 3 – trials conducted using administrative databases do not adequately report elements related to use of databases
There is growing interest in the use of administrative databases to evaluate health care interventions [1]. Health system administrative databases include information collected for administrative or billing purposes (e.g., Medicare data in the United States) that is routinely collected during clinic, hospital, laboratory, or pharmacy visits. These data can provide a readily available source of “real-world” data on a large population over expansive geographic regions [2]. Administrative databases are increasingly accessible to researchers and are being more frequently utilized in randomized controlled trials (RC...
Source: Journal of Clinical Epidemiology - September 10, 2021 Category: Epidemiology Authors: Mahrukh Imran, Kimberly Mc Cord, Stephen J. McCall, Linda Kwakkenbos, Margaret Sampson, Ole Fr öbert, Chris Gale, Lars G. Hemkens, Sinéad M Langan, David Moher, Clare Relton, Merrick Zwarenstein, Edmund Juszczak, Brett D. Thombs, on behalf of CONSORT Ex Tags: Original Article Source Type: research

Kappa and AC1/2 statistics: beyond the paradox
Dear Editor, (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 10, 2021 Category: Epidemiology Authors: Silvia Minozzi Source Type: research

A review found small variable blocking schemes may not protect against selection bias in randomised controlled trials
Randomised Controlled Trials (RCTs) are considered the gold standard to assess a difference of effect between treatment groups (1, 2). They need to be designed to minimise bias, including selection bias, which can ensue if the method used to conceal the allocation sequence is inadequate or predictable (3). Heterogeneity, in meta-analyses, of baseline variables, such as age, is an indicator that some of the included trials have been subverted and therefore impacted by selection bias (4-6). Such heterogeneity may be as a result of using ‘restricted randomisation’. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 10, 2021 Category: Epidemiology Authors: Laura Clark, Lauren Burke, Dr Rachel Margaret Carr, Elizabeth Coleman, Gareth Roberts, Professor David J Torgerson Source Type: research

Reporting Transparency and Completeness in Trials: Paper 3 - Trials conducted using administrative databases do not adequately report elements related to use of databases
There is growing interest in the use of administrative databases to evaluate health care interventions [1]. Health system administrative databases include information collected for administrative or billing purposes (e.g., Medicare data in the United States) that is routinely collected during clinic, hospital, laboratory, or pharmacy visits. These data can provide a readily available source of “real-world” data on a large population over expansive geographic regions [2]. Administrative databases are increasingly accessible to researchers and are being more frequently utilised in randomised controlled trials (RC...
Source: Journal of Clinical Epidemiology - September 10, 2021 Category: Epidemiology Authors: Mahrukh Imran, Kimberly Mc Cord, Stephen J. McCall, Linda Kwakkenbos, Margaret Sampson, Ole Fr öbert, Chris Gale, Lars G. Hemkens, Sinéad M Langan, David Moher, Clare Relton, Merrick Zwarenstein, Edmund Juszczak, Brett D. Thombs, on behalf of CONSORT E Source Type: research

Inadequate  reporting of participants eligible for randomized controlled trials – A Systematic Review and Meta-Analysis.
Objective: to characterize randomized controlled trials (RCTs) that did not report the overall number of participants assessed for eligibility and to identify factors associated with higher enrollment rates.Study design and setting: Systematic review and meta-analysis of RCTs in several pre-defined fields in internal medicine. We randomly extracted 360 articles that were published in 2017. Trials that reported numbers of assessed for eligibility patients were compared with those who did not. Recruitment rates were calculated in order to investigate whether they were associated with trial characteristics. (Source: Journal o...
Source: Journal of Clinical Epidemiology - September 10, 2021 Category: Epidemiology Authors: Adi Turjeman, Itamar Poran, Vered Daitch, Noam Tau, Irit Ayalon-Dangur, Jeries Nashashibi, Dafna Yahav, Mical Paul, Leonard Leibovici Source Type: research

Applying resolved and remission codes reduced prevalence of multimorbidity in an urban multi-ethnic population
What is new? (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 10, 2021 Category: Epidemiology Authors: Lesedi Ledwaba-Chapman, Alessandra Bisquera, Martin Gulliford, Hiten Dodhia, Stevo Durbaba, Mark Ashworth, Yanzhong Wang Source Type: research

Interrater reliability of ROB2 – an alternative measure and way of categorization
we read with great interest the paper of Minozzi et al. [1]. Although their findings are of eminent interest, we would like to point out two issues: (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 9, 2021 Category: Epidemiology Authors: Martin Loef, Harald Walach, Stefan Schmidt Source Type: research

Domperidone Increases Harmful Cardiac Events in Parkinson's Disease: A Bayesian Re-Analysis of an Observational Study
Over the last two decades, Bayesian methods have gained popularity and their implementations have widened in statistical sciences and applied fields. From a healthcare perspective, regulatory agencies are now accepting Bayesian approaches for earlier phases of drug development [1,2] and comparative effectiveness research [3,4]. At the drug development level, Bayesian adaptive analytical approaches have been particularly attractive for achieving greater efficiency in reducing sample size, time and cost of trials [5]. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 7, 2021 Category: Epidemiology Authors: Gis èle Nakhlé, James M. Brophy, Christel Renoux, Paul Khairy, Patrick Bélisle, Jacques LeLorier Source Type: research

Meta-analysis for individual participant data with a continuous exposure: a case study
For categorical exposure variables meta-analysis methods for summary statistics, such as relative risks or hazard ratios, are well-known [1]. The meta-analysis involves calculating weighted averages of the estimates from each study, with weights inversely proportional to their precision (or standard errors). The methods can take into account within-study correlation, heterogeneity across studies, and non-linear exposure-outcome associations [2, 3]. However, if individual participant data (IPD) are available there are other opportunities for meta-analysis [4]. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 3, 2021 Category: Epidemiology Authors: Darsy Darssan, Gita D. Mishra, Darren C. Greenwood, Sven Sandin, Eric J. Brunner, Sybil L. Crawford, Samar R. El Khoudary, Maria Mori Brooks, Ellen B. Gold, Mette Kildev æld Simonsen, Hsin-Fang Chung, Elisabete Weiderpass, Annette J. Dobson Tags: Original Article Source Type: research

Systematic review of diabetic eye disease practice guidelines: more applicability, transparency and development rigour are needed
To assess the quality of diabetic eye disease clinical practice guidelines (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 2, 2021 Category: Epidemiology Authors: Rajendra Gyawali, Melinda Toomey, Fiona Stapleton, Barbara Zangerl, Lisa Dillon, Kam Chun Ho, Lisa Keay, Sally Marwan M Alkhawajah, Gerald Liew, Isabelle Jalbert Source Type: research

Urban RCT participants were healthier than non-participants or rural women
To investigate sociodemographic characteristics and physical and mental health indicators between participants and non-participants of a large-scale two-year exercise RCT including non-invited women living in nearby rural area in Finland. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 2, 2021 Category: Epidemiology Authors: Tommi Vilpunaho, Reijo Sund, Heli Koivumaa-Honkanen, Risto Honkanen, Heikki Kr öger, Toni Rikkonen Source Type: research

Regression discontinuity analysis demonstrated varied effect of Treat-All on CD4 testing among Southern African countries
: To determine whether Treat-All policy impacted laboratory testing practices of antiretroviral therapy (ART) programs in Southern Africa. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 2, 2021 Category: Epidemiology Authors: Elizabeth Zaniewski, Ellen Brazier, Cam Ha Dao Ostinelli, Robin Wood, Meg Osler, Karl-G ünter Technau, Joep J van Oosterhout, Nicola Maxwell, Janneke van Dijk, Hans Prozesky, Matthew P Fox, Jacob Bor, Denis Nash, Matthias Egger Source Type: research

Robustness Issues of Clinical Significance and Clinical Importance
Four articles address issues related to the measurement challenges and the relationship between statistical significance and clinical importance. A commentary by Li, Walter and Thabane [20-00282] comment on a series of challenges of over-emphasis on statistical significance: i) studies that are not statistically significant but are clinically relevant e.g. due to poor statistical power; (ii) failure to distinguish between absence of evidence, versus evidence of absence; (iii) the fragility of statistical significance where a difference of a handful of outcomes makes or loses statistical significance; (iv) the temptation of...
Source: Journal of Clinical Epidemiology - September 1, 2021 Category: Epidemiology Authors: Peter Tugwell, David Tovey Tags: Editors Choice Sept 2021 Source Type: research

Editorial Board
(Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 1, 2021 Category: Epidemiology Source Type: research

Table of Contents
(Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - September 1, 2021 Category: Epidemiology Source Type: research