The methodological quality is insufficient in clinical practice guidelines in the context of COVID-19: systematic review
The novel Coronavirus Disease 2019 (COVID-19) spread rapidly worldwide and the number of cases increased globally at an accelerated rate [1,2]. While measures are essential to mitigate the impact of the pandemic specifically, we also need immediate and targeted action to continue effective and safe healthcare generally. Necessary actions to avoid collateral damages to patients range from adapting healthcare to maximizing safety while providing continuation of usual healthcare to rapidly restart routine care in the areas where healthcare has been reduced due to mandated lockdowns. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - March 7, 2021 Category: Epidemiology Authors: Tanja A Stamm, Margaret R Andrews, Erika Mosor, Valentin Ritschl, Linda C Li, Jasmin K Ma, Adalberto Campo Arias, Sarah Baker, Nicola W Burton, Mohammad Eghbali, Natalia Fernandez, Ricardo JO Ferreira, Gabriele G äbler, Souzi Makri, Sandra Mintz, Rikke H Source Type: research

Patient-Reported Outcome Measures in Core Outcome Sets targeted overlapping domains but through different instruments
The last years have witnessed an increased commitment by the health services research and professional community to involving patients and the public in the development, delivery and evaluation of health care services [1]. In parallel, the assessment of patient-reported outcomes (PROs) has gained international traction as one of the enablers of patient-centered healthcare. Regulatory agencies define a PRO as any report of the status of a patient's health condition that comes directly from the patient, without interpretation by a practitioner or anyone else [2,3]. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - March 5, 2021 Category: Epidemiology Authors: Oriana Ciani, Maximilian Salcher-Konrad, Michela Meregaglia, Kathrine Smith, Sarah L Gorst, Susanna Dodd, Paula R Williamson, Giovanni Fattore Source Type: research

A Method for Calculating the Fragility Index of Continuous Outcomes
In the era of evidence-based medicine, interpretation of literature relies on many factors. Perhaps the most important factor is the “statistical significance” of a result, often reported as a p-value less than 0.05. It has become a ubiquitous fixture throughout medical literature: a reductive value that accepts or rejects the hypothesis. However, it is susceptible to abuse and overemphasis. P-values fail to capture informati on about the clinical relevance of results, how robust a “significant” result truly is, and are subject to manipulation. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - March 4, 2021 Category: Epidemiology Authors: Jon-Michael E. Caldwell, Keon Youssefzadeh, Orr Limpisvasti Source Type: research

Adverse event recording failed to reflect potential harms: A review of trial protocols of behavioural, lifestyle and psychological therapy interventions.
Non-pharmacological interventions can cause harm or unintended effects, yet within public health and psychological therapy fields, clinical trials have not adequately considered these outcomes [1 –7]. This is of concern since intervention assessment in clinical trials requires risk-benefit analysis. Beneficial effects must be considered alongside harmful effects. This could leave harms, typically termed Adverse Events (AEs), unidentified. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - March 4, 2021 Category: Epidemiology Authors: Diana Papaioannou, Cindy Cooper, Cara Mooney, Rachel Glover, Elizabeth Coates Source Type: research

How to use GRADE when there is “no” evidence? A case study of the expert evidence approach
One essential requirement of trustworthy guidelines is that they should be based on systematic reviews of the best available evidence. The GRADE Working Group has provided guidance for evaluating the certainty of evidence based on several domains.However, for many clinical questions, published evidence may be limited, too indirect or simply not exist. These areas of sparse evidence often reflect key questions that are critical to address in clinical practice guidelines due to the uncertainty among health care providers. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - March 3, 2021 Category: Epidemiology Authors: Reem A. Mustafa, Carlos A. Cuello Garcia, Meha Bhatt, John J. Riva, Sara Vesely, Wojtek Wiercioch, Robby Nieuwlaat, Payal Patel, Sheila Hanson, Fiona Newall, John Wiernikowski, Paul Monagle, Holger J Sch ünemann Tags: Original Article Source Type: research

Medical record bias in documentation of obstetric and neonatal clinical quality of care indicators in Uganda
Despite improvements in health service coverage in low- and middle-income countries (LMICs), the quality of care (QoC) is often poor.1 –4 In eight LMICs, a weak correlation between healthcare coverage and QoC was reported.2 In Ethiopia, the national crude coverage of antenatal care was 62.4 percent; however, quality was significantly lower at 34.4 percent for the antenatal care visits in 2016.5 (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - March 2, 2021 Category: Epidemiology Authors: Min Kyung Kim, Joy Noel Baumgartner, Jennifer Headley, Julius Kirya, James Kaggwa, Joseph R. Egger Source Type: research

Certainty of evidence and intervention's benefits & harms are key determinants of guidelines ’ recommendations
Development of trustworthy clinical practice guidelines (CPG) represents an important tool for improving clinical decision-making and optimizing patient outcomes.1-3,4,5 Although standards for producing trustworthy CPGs rest on methodological principles developed in evidence-based health care (EBHC) fields, 1,6 –8 CPGs’ trustworthiness ultimately depends on how guideline panel members exercise their individual and collective expertise to formulate recommendations. 9–11 (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - March 1, 2021 Category: Epidemiology Authors: Benjamin Djulbegovic, Iztok Hozo, Shelly-Anne Li, Marianne Razavi, Adam Cuker, Gordon Guyatt Source Type: research

Vancouver Coastal Health informed COVID-19 response by applying rapid review methodology: Reply to Tricco.
We read with great interest the commentary written by Tricco et al. (2020) [1] titled “Rapid review methods more challenging during COVID-19: commentary with a focus on 8 knowledge synthesis steps”. As members of a new research team deployed to support public health decision-making on COVID-19, we appreciated the succinct overview of challenges associated with employing rapid rev iew methodology in the context of COVID-19. In this article, we present our approach to handling these challenges from the perspective of applied researchers working within a healthcare organization. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - March 1, 2021 Category: Epidemiology Authors: Linda Dix-Cooper, Martin Dawes, Mina Park Source Type: research

Measuring the success of blinding in placebo-controlled trials: should we be so quick to dismiss it?
From being almost universally regarded as a methodological virtue of clinical trials and being included in the original 2001 Consolidated Standards of Reporting Trials (CONSORT) statement [1], measuring the success of blinding has fallen out of fashion. Subsequent versions of CONSORT removed this recommendation based on the correct view that it can lead to misleading inferences about causes of the failure to blind [2,3]. In addition, Anand, et al.[4] recently questioned the need to blind patients and clinicians or measure and report whether blinding was done successfully. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 28, 2021 Category: Epidemiology Authors: Rebecca K Webster, Felicity Bishop, Gary S Collins, Andrea WM Evers, Tammy Hoffmann, J. Andr é Knottnerus, Sarah E Lamb, Helen Macdonald, Claire Madigan, Vitaly Napadow, Amy Price, Jonathan L Rees, Jeremy Howick Source Type: research

Reporting and methodological quality of COVID-19 systematic reviews needs to be improved: an evidence mapping
: To assess the reporting and methodological quality of COVID-19 systematic reviews, and to analyze trends and gaps in the quality, clinical topics, author countries, and populations of the reviews using an evidence mapping approach. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 28, 2021 Category: Epidemiology Authors: Yanfei Li, Liujiao Cao, Ziyao Zhang, Liangying Hou, Yu Qin, Xu Hui, Jing Li, Haitong Zhao, Gecheng Cui, Xudong Cui, Rui Li, Qingling Lin, Xiuxia Li, Kehu Yang Source Type: research

Missing at random assumption made more plausible: evidence from the 1958 British  birth cohort
: Non-response is unavoidable in longitudinal surveys. The consequences are lower statistical power and the potential for bias. We implemented a systematic data-driven approach to identify predictors of non-response in the National Child Development Study (NCDS; 1958 British birth cohort). Such variables can help make the missing at random assumption more plausible, which has implications for the handling of missing data (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 26, 2021 Category: Epidemiology Authors: Tarek Mostafa, Tarek Mostafa, Martina Narayanan, Benedetta Pongiglione, Brian Dodgeon, Alissa Goodman, Richard Silverwood, George Ploubidis Source Type: research

An international core outcome set for evaluating interventions to improve informed consent to clinical trials: the ELICIT Study
Informed consent is central to participation in clinical research. The requirement of informed consent for participation in randomised controlled trials (RCTs) was established to allow people to recognise and consider potential risks or benefits of participating, and to respect their autonomous choices [1]. The adequacy of these processes has, however, been called into question [2, 3]. Concern stems from evidence that trial participants often lack understanding (so cannot be considered ‘informed’) about the trial rationale and the risks of interventions [4]. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 26, 2021 Category: Epidemiology Authors: Katie Gillies, Paula R Williamson, Vikki A Entwistle, Heidi Gardner, Shaun Treweek, Marion K Campbell Source Type: research

Reply to: Let us not rush back to odds ratios in meta-analysis
Leucht [1] responds to our paper [2] and raises the point that odds ratios (OR) are less intuitive and suggests that we should temper the recommendation that ORs should be preferred over relative risks (RRs) in meta-analyses. Leucht suggests that even if meta-analysts were to derive RRs from ORs, since they use average baseline risks from the included trials, the RR calculated directly will usually be similar to that derived from an OR. While it may be possible (as in the example cited by Leucht) for the RR and OR to numerically coincide, there are two reasons why this cannot be recommended. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 25, 2021 Category: Epidemiology Authors: Suhail A. Doi, Luis Furuya-Kanamori, Chang Xu Source Type: research

Let us not rush back to odds ratios without a recommendation to convert them to interpretable measures
Doi et al.1 suggest that odds ratios should be preferred over relative risks in meta-analyses. While I do not doubt the mathematical justifications in their article, their reasoning is mainly based on an argument which ignores the reality of systematic reviews. Their main argument is that relative risks in contrast to odds ratios depend on the prevalence of the outcome. But even if meta-analysts derive relative risks from odds ratios, they again almost always use the average prevalence in the control groups of the trials for their calculations. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 25, 2021 Category: Epidemiology Authors: Prof. Stefan Leucht Tags: Letter to the editor Source Type: research

Self-reported medication use among coronary heart disease patients showed high validity compared with dispensing data
To validate self-reported use of medications for secondary prevention of coronary heart disease (CHD) in a population-based health study by comparing self-report with pharmacy dispensing data, and explore different methods for defining medication use in prescription databases. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 24, 2021 Category: Epidemiology Authors: Elisabeth Pedersen, Kieu Nhi Lise Truong, Beate Hennie Garcia, Kjell H. Halvorsen, Kristian Svendsen, Anne Elise Eggen, Marit Waaseth Tags: Original Article Source Type: research

CommentaryAn introduction to mediation analyses of randomised controlled trials
Mediation analyses of randomised controlled trials can be used to investigate the mechanisms by which health interventions cause outcomes. In this article we provide a brief introduction to mediation analysis in the context of randomised controlled trials. We introduce common target effects, causal assumptions, estimation approaches, and illustrate these concepts using a published mediation analysis of the Systolic Blood Pressure Intervention Trial (SPRINT). Well-conducted mediation analyses of randomised trials can provide meaningful insights to guide clinical and policy decisions. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 15, 2021 Category: Epidemiology Authors: Aidan G. Cashin, Hopin Lee Source Type: research

Commentary: Carrasco-Labra et al. Minimal important difference estimates for patient-reported outcomes: A systematic survey
Carrasco-Labra et al [1] are to be congratulated for opening the door to more useful and useable information resulting from reviews of outcome measurement instruments. Rather than existing in the files of the authors, and reported in an article, they have moved the findings from a thorough review of the literature onto an online, searchable database of 5,324 minimally important difference (MID) values extracted for 526 instruments from 585 studies. At a minimum, they have just saved researchers, clinicians and policy makers needing estimates of MIDs countless hours of work finding these often elusive values within the lite...
Source: Journal of Clinical Epidemiology - February 15, 2021 Category: Epidemiology Authors: D.E. Beaton, L.J. Maxwell Tags: Commentary Source Type: research

External validation of clinical prediction models: simulation-based sample size calculations were more reliable than rules-of-thumb
Clinical prediction models utilise multiple variables (predictors) in combination to predict an individual patient's risk of a clinical outcome [1-3]. An important part of prediction model research is assessing the predictive performance of a model, in terms of whether the model's predicted risks: (i) discriminate between individuals that have the outcome and those that do not, and (ii) calibrate closely with observed risks (i.e. predicted risks are accurate). This can be done by internal validation (such as bootstrapping) using the development data, and by external validation using independent data (i.e. (Source: Journal ...
Source: Journal of Clinical Epidemiology - February 14, 2021 Category: Epidemiology Authors: Kym IE Snell, Lucinda Archer, Joie Ensor, Laura J Bonnett, Thomas PA Debray, Bob Phillips, Gary S Collins, Richard D Riley Tags: Original Article Source Type: research

A proposed framework to guide evidence synthesis practice for meta-analysis with zero-events studies
Meta-analysis has been widely used to synthesis evidence for studies of the same topic, through either a fixed-effect or a random-effect scheme, as an effort to obtain more precise and comprehensive results for decision-making. While for meta-analysis of rare events, researchers often face the problem of how to deal with zero-events. Zero-events generally occur when the risk of events is low, the sample size is small, or the follow-up period is short - these are frequently seen with safety outcomes [1-2]. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 12, 2021 Category: Epidemiology Authors: Chang Xu, Luis Furuya-Kanamori, Liliane Zorzela, Lifeng Lin, Sunita Vohra Tags: Original Article Source Type: research

Use of GRADE in evidence syntheses published in high-impact-factor nutrition journals: a methodological survey
According to the most recent report by the Global Burden of Disease study group, non-communicable diseases, such as cardiovascular disease (CVD), cancer and type 2 diabetes (T2D), accounted for over 70% of total deaths worldwide [1]. Nearly 20% of all premature deaths worldwide and 15% of all disability-adjusted life years were associated with dietary risk factors [2]. Moreover, suboptimal intake of 12 major food groups was associated with ∼50% of all disability-adjusted life years due to nutrition-related chronic diseases such as CVD, T2D, and colorectal cancer [3]. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 12, 2021 Category: Epidemiology Authors: Sarah S Werner, Nadine Binder, Ingrid Toews, Holger J Sch ünemann, Joerg J Meerpohl, Lukas Schwingshackl Source Type: research

Methodological review showed that time-to-event outcomes are often inadequately handled in cluster randomized trials
What is new? (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 9, 2021 Category: Epidemiology Authors: Agn ès Caille, Elsa Tavernier, Monica Taljaard, Solène Desmée Source Type: research

Updating guidance for reporting systematic reviews: development of the PRISMA 2020 statement
To describe the processes used to update the PRISMA 2009 statement for reporting systematic reviews, present results of a survey conducted to inform the update, summarise decisions made at the PRISMA update meeting, and describe and justify changes made to the guideline. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 9, 2021 Category: Epidemiology Authors: Matthew J Page, Joanne E McKenzie, Patrick M Bossuyt, Isabelle Boutron, Tammy C Hoffmann, Cynthia D Mulrow, Larissa Shamseer, Jennifer M Tetzlaff, David Moher Source Type: research

Existing validated clinical prediction rules for predicting response to physiotherapy interventions for musculoskeletal conditions have limited clinical value: A systematic review
Clinical prediction rules (CPRs) can support evidence-based decision-making at the point of patient care [1]. CPRs quantify the contribution of multiple predictors from a patient's history, examination or diagnostic tests and stratify patients according to the probability of having specific diagnostic, prognostic or therapeutic outcomes [2]. Before widespread implementation, CPRs should undergo three development stages: (i) Derivation: predictors are identified and combined; (ii) Validation: the CPR is tested for discrimination and calibration and (iii) Impact analysis: the CPR is tested in terms of patient outcomes, clini...
Source: Journal of Clinical Epidemiology - February 9, 2021 Category: Epidemiology Authors: Mary E. Walsh, Helen P. French, Emma Wallace, Sarah Madden, Patricia King, Tom Fahey, Rose Galvin Source Type: research

Author queries via email text elicited high response and took less reviewer time than data forms – a randomised study within a review
Systematic evidence syntheses depend on the quality of reporting and completeness of data available from included studies. When methods are not clearly described or data are incomplete in primary study reports, Cochrane guidance recommends that reviewers correspond with investigators to obtain additional information [1, 2]. Study authors had been contacted in 234/319 (73%) Cochrane intervention reviews published in 2016 [3]. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 9, 2021 Category: Epidemiology Authors: K äthe Goossen, Tanja Rombey, Charlotte M. Kugler, Karina K. De Santis, Dawid Pieper Tags: Original Article Source Type: research

Covariates adjustment questioned conclusions of predictive analyses: an illustration with the Kidney Donor Risk Index
95% Confidence Interval (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 9, 2021 Category: Epidemiology Authors: E. Dantan, F. Le Borgne, M. Giral, A. Dion, AH Querard, Y. Foucher Source Type: research

Metabolomics data complemented drug use information in epidemiological databases: pilot study of potential kidney donors
Epidemiology has been an important field of research in health sciences for decades [1, 2]. Epidemiological studies mostly rely on data obtained through anamnesis, questionnaires, and basic measurements (e.g. anthropometric parameters, laboratory markers), and also, more recently, on complex data obtained using ‘omics’ technologies [3-6]. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 9, 2021 Category: Epidemiology Authors: Frank Klont, Daan Kremer, Antonio W. Gomes Neto, Stefan P. Berger, Daan J. Touw, Eelko Hak, Ron Bonner, Stephan J.L. Bakker, G érard Hopfgartner Tags: Original Article Source Type: research

No Limitations to Language, Date, Publication Type, and Publication Status in Search Step of Systematic Reviews
What is new (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 7, 2021 Category: Epidemiology Authors: Ghazaleh Aali, Farhad Shokraneh Tags: Letter to the editor Source Type: research

A new tool to assess Clinical Diversity In Meta ‐analyses (CDIM) of interventions
A meta-analysis of high-quality randomised clinical trials is considered the best available evidence in health care management and often forms the basis of clinical practice guidelines and for protocols of randomised clinical trials [1]. Still, undetected clinical diversity, methodological and/or statistical heterogeneity may lead to inappropriate conclusions or recommendations. Several potential sources of heterogeneity exist among trials included in systematic reviews and meta-analyses. Clinical diversity can be characterised by variability in settings, participants, characteristics of interventions and comparators, use ...
Source: Journal of Clinical Epidemiology - February 5, 2021 Category: Epidemiology Authors: M Barbateskovic, TM Koster, RJ Eck, M Maagaard, A Afshari, F Blokzijl, M Cronhjort, W Dieperink, ML Fabritius, J Feinberg, C French, B Gareb, A Geisler, A Granholm, B Hiemstra, R Hu, G Imberger, BT Jensen, AB Jonsson, O Karam, DZ Kong, SK Korang, G Koster Source Type: research

Registered trials address questions already answered with high-certainty evidence: a sample of current redundant research.
What is new? (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 5, 2021 Category: Epidemiology Authors: Laura Vergara Merino, Catalina Verdejo, Juan Victor Ariel Franco, Camila Escobar Liquitay, rard Urr útiaG Ge, Rachel Klabunde, Paulina Pérez, Luna Sánchez, Eva Madrid Source Type: research

The impact of responder analyses on trial power in patients with kidney disease and depression: A simulation study
Investigators can transform continuous data into dichotomous data by splitting it at a threshold (e.g. its mean, median, an arbitrary value or patient important threshold) and designating individuals above and below this threshold into two separate groups1. Investigators commonly perform dichotomization to simplify the analysis and interpretation of results. Other reasons include conservative hypothesis testing1 that is often a prerequisite for regulatory approval2. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 5, 2021 Category: Epidemiology Authors: David Collister, Shrikant Bangdiwala, Michael Walsh, Rajibul Mian, Shun Fu Lee, Toshi Furukawa, Gordon Guyatt Source Type: research

Tutorial: a nontechnical explanation of the counterfactual definition of effect modification and interaction
Causal questions addressed by (clinical) epidemiological studies usually focus on the causal effect of a single exposure on a certain outcome. For instance, whether and how exposure to a specific risk factor or medical treatment causes the occurrence or cure of some disease. It is well-recognized, however, that most outcomes are not caused by single exposures in isolation but by multiple exposures in combination. That is why experimental and observational studies frequently report results of subgroup or stratified analyses [4-12], to explore if the effect of the primary exposure under study depends on the level of another ...
Source: Journal of Clinical Epidemiology - February 3, 2021 Category: Epidemiology Authors: Martijn J.L. Bours Source Type: research

The Impact of Gender on Scientific Writing: An Observational Study of Grant Proposals
Women have been underrepresented in the biomedical field within academia, and this gap widens at each career step, including promotion to full professor.[1] Studies have shown that in academia, men's competencies, productivity, leadership potential, and work quality are consistently evaluated to be superior to women based on gender identification alone.[2 –5] There is also evidence that women earn lower salaries and receive fewer research grants.[6,7] (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 2, 2021 Category: Epidemiology Authors: Marina Christ Franco, Danielle B. Rice, Helena Silveira Schuch, Odir Antonio Dellagostin, Maximiliano S érgio Cenci, David Moher Source Type: research

Meta-epidemiological study of publication integrity, and quality of conduct and reporting of randomized trials included in a systematic review of low back pain
This article comprehensively describes the quality of conduct, reporting, and publication integrity characteristics for all trials included in a large Cochrane review update on exercise therapy for chronic low back pain, comparing those published by predatory publishers with those published by non-predatory publishers. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 2, 2021 Category: Epidemiology Authors: J.A. Hayden, J. Ellis, R. Ogilvie, L. Boulos, S. Stanojevic Source Type: research

A conversation on health research collaborations and career with Dr. Gordon Guyatt: A Commentary
This text builds on a conversation with Dr. Gordon Guyatt who provided guidance to trainees on interdisciplinary collaboration and work-life balance as part of a graduate-level biostatistics course in September 2020. The participants in the conversation comprised a group of clinicians, methodologists and biostatisticians, ranging from junior trainees to world-renowned established researchers. Biostatisticians, methodologists and clinicians often collaborate in conducting clinical research, calling upon interpersonal soft skills that are rarely explicitly addressed in undergraduate and graduate coursework. (Source: Journal ...
Source: Journal of Clinical Epidemiology - February 1, 2021 Category: Epidemiology Authors: Isabelle Johansson, Leen Naji, Myanca Rodrigues, Kishore Kumar Akula, Zheng Jing Hu, Jeffrey Kay, Lehana Thabane, Gordon Guyatt Source Type: research

Double-zero-event studies matter: a re-evaluation of physical distancing, face masks, and eye protection for preventing person-to-person transmission of COVID-19 and its policy impact
In a recent timely systematic review, Chu et al. (Chu et al., 2020) assessed the effectiveness of face masks, eye protection, and physical distancing for preventing COVID-19. Because the sample sizes are not large, especially in some studies of COVID-19, this review contains a considerable number of studies with zero counts of infection events, creating challenges in estimating effect sizes. If zero counts appear in both groups, this double-zero-event study (DZS) is omitted from the analyses, as implied in the forest plots in Chu et al. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 1, 2021 Category: Epidemiology Authors: Mengli Xiao, Lifeng Lin, James S. Hodges, Chang Xu, Haitao Chu Tags: Letter to the editor Source Type: research

Framework for the Treatment And Reporting of Missing data in Observational Studies: The TARMOS framework
We present a practical framework for handling and reporting the analysis of incomplete data in observational studies, which we illustrate using a case study from the Avon Longitudinal Study of Parents and Children. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - February 1, 2021 Category: Epidemiology Authors: Lee KJ, Tilling K, Cornish RP, Little RJA, Bell ML, Goetghebeur E, Hogan JW, Carpenter JR, the STRATOS initiative Tags: Original Article Source Type: research

International application of PROMIS ® computerized adaptive tests: US versus country-specific item parameters can be consequential for individual patient scores
Item response theory (IRT) is increasingly used to create item banks as the basis for computerized adaptive testing (CAT) for measuring patient-reported outcomes (PROs) (Cappelleri et al., 2014, Chang, 2007, Edelen and Reeve, 2007, Nguyen et al., 2014, Reeve et al., 2007). With CAT, after a starting item, subsequent items are selected by the computer based on participants ’ responses to previous items (Embretsen and Reise, 2000, Thissen and Wainer, 2001). With CAT, reliable scores can be obtained with only a few relevant questions (Cook et al., 2005). (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 29, 2021 Category: Epidemiology Authors: Caroline B. Terwee, Martine H.P. Crins, Leo D. Roorda, Karon F. CooK, David Cella, Niels Smits, Benjamin D. Schalet Tags: Original Article Source Type: research

Transparency, trust and minimizing burden to increase recruitment and recruitment in trials: a systematic review
What is new? (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 26, 2021 Category: Epidemiology Authors: Patrizia Natale, Valeria Saglimbene, Marinella Ruospo, Andrea Matus Gonzalez, Giovanni FM Strippoli, Nicole Scholes-Robertson, Chandana Guha, Jonathan C Craig, Armando Teixeira-Pinto, Tom Snelling, Allison Tong Source Type: research

Design, methods, and reporting of impact studies of cardiovascular clinical prediction rules are suboptimal: A systematic review
To evaluate design, methods, and reporting of impact studies of cardiovascular clinical prediction rules (CPRs). (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 26, 2021 Category: Epidemiology Authors: Jong-Wook Ban, Mei Sum Chan, Tonny Brian Muthee, Arsenio Paez, Richard Stevens, Rafael Perera Source Type: research

Adverse drug reaction risks obtained from meta-analyses and pharmacovigilance disproportionality analyses are correlated in most cases
What is new? (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 25, 2021 Category: Epidemiology Authors: Charles Khouri, Camille Petit, Michel Tod, Marion Lepelley, Bruno Revol, Matthieu Roustit, Jean-Luc Cracowski Tags: Original Article Source Type: research

Key concepts in clinical epidemiology: detecting and dealing with heterogeneity in meta-analyses
In a meta-analysis, a question always arises. Is it worthwhile to combine estimates from studies of different populations using various formulations of an intervention, evaluating outcomes measured differently? Sometimes even study designs differ. Differences are expected in a meta-analysis. These may be negligible, and a pooled estimate of effect can guide the clinical decision. However, when the differences are large, this estimate may mislead. Effect estimates from study to study differ because of real differences (between-study variability) and because of chance (within-study variability). (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 20, 2021 Category: Epidemiology Authors: Cynthia P. Cordero, Antonio L. Dans Tags: Series Source Type: research

Editor's choice: February 2021
There has never been a time when evidence was more important or under such intense scrutiny. A time when every key study is eagerly awaited and devoured on arrival as though the health and hopes of the global community rest on its shoulders. And yet, as we know, evidence is frequently flawed, equivocal in its findings and open to interpretation, even though it forms a critical element of most guidelines and decision support tools. Over recent years the concept of a continuous evidence eco-system that comprises different but mutually dependent processes, a broad range of actors and stakeholders, and the increased exploitati...
Source: Journal of Clinical Epidemiology - January 20, 2021 Category: Epidemiology Authors: David Tovey, Peter Tugwell Tags: Editorial Source Type: research

Editorial Board
(Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 20, 2021 Category: Epidemiology Source Type: research

Table of Contents
(Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 20, 2021 Category: Epidemiology Source Type: research

An online tool for the calculation and graphical presentation of the NNTnet
Immediately after Li Guowei et  al. proposed the number needed to treat (NNT) for net effect (NNTnet) as a metric for measuring combined benefits and harms [1], we have implemented this metric to describe the net effect of point-of-care C-reactive protein testing to reduce antibiotic prescribing for respiratory tract infections (RTI) in primary care in a systematic review and meta-analysis of randomized controlled trials [2]. Inspired by their proposed metric, we also created a tool to calculate the NNTnet based on the NNT for benefit (NNTB) and the NNT for harm (NNTH) and proposed a way to graphically present the res...
Source: Journal of Clinical Epidemiology - January 20, 2021 Category: Epidemiology Authors: Samuel Coenen, Annelies Colliers Tags: Letter to the Editor Source Type: research

Natural language processing was effective in assisting rapid title and abstract screening when updating systematic reviews
Objectives: To examine whether the use of natural language processing (NLP) technology is effective in assisting rapid title and abstract screening when updating a systematic review.Study Design: Using the searched literature from a published systematic review, we trained and tested an NLP model that enables rapid title and abstract screening when updating a systematic review. The model was a light gradient boosting machine (LightGBM), an ensemble learning classifier which integrates four pretrained Bidirectional Encoder Representations from Transformers (BERT) models. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 20, 2021 Category: Epidemiology Authors: Xuan Qin, Jiali Liu, Yuning Wang, Yanmei Liu, Ke Deng, Yu Ma, Kang Zou, Ling Li, Xin Sun Source Type: research

The MethodologicAl STandards for Epidemiological Research (MASTER) scale demonstrated a unified framework for bias assessment
: This paper presents a unified framework for assessment of the methodological quality of analytic study designs. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 20, 2021 Category: Epidemiology Authors: Jennifer C. Stone, Kathryn Glass, Justin Clark, Merel Ritskes-Hoitinga, Zachary Munn, Peter Tugwell, Suhail A.R. Doi Source Type: research

The reporting of co-enrolment in protocols of publicly-funded randomised controlled trials was infrequent and variable
To explore the approach to participant co-enrolment in publicly-funded randomised-controlled trials (RCTs) and to consider its impact on study recruitment. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 20, 2021 Category: Epidemiology Authors: Tanaya Maslekar, Samuel Peat, Jamshaid Karim, Catherine Moriarty, David G. Jayne, Stephen J. Chapman Tags: Original Article Source Type: research

Online tool for the calculation and graphical presentation of the NNTnet
(Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 20, 2021 Category: Epidemiology Authors: Samuel Coenen, Annelies Colliers Tags: Letter to the editor Source Type: research

Real-time imputation of missing predictor values improved the application of prediction models in daily practice
– In clinical practice, many prediction models cannot be used when predictor values are missing. We therefore propose and evaluate methods for real-time imputation. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - January 19, 2021 Category: Epidemiology Authors: Nijman SWJ, Groenhof TKJ, Hoogland J, Bots ML, Brandjes M, Jacobs JJL, Asselbergs FW, Moons KGM, Debray TPA Tags: Original Article Source Type: research