Pharmacovigilance studies without a priori hypothesis: systematic review highlights inappropriate multiple testing correction procedures
The purpose of this study was to systematically review the statistical methods used in pharmacovigilance studies without a priori hypotheses. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - August 30, 2023 Category: Epidemiology Authors: Louis Gaucher, Pierre Sabatier, Sandrine Katsahian, Anne-Sophie Jannot Tags: Review Article Source Type: research
Pharmacovigilance studies without a priori hypothesis systematic review highlights inappropriate multiple testing correction procedures.
The purpose of this study was to systematically review the statistical methods used in pharmacovigilance studies without a priori hypotheses. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - August 30, 2023 Category: Epidemiology Authors: Louis Gaucher, Pierre Sabatier, Sandrine Katsahian, Anne-Sophie Jannot Tags: Review Source Type: research
The barriers and facilitators for the implementation of clinical practice guidelines in healthcare: an umbrella review of qualitative and quantitative literature
To identify barriers and facilitators of clinical practice guidelines (CPGs) implementation, and map those factors to the Theoretical Domains Framework (TDF) and Behavior Change Wheel (BCW). (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - August 30, 2023 Category: Epidemiology Authors: Pengxiang Zhou, Lu Chen, Ziyang Wu, Ente Wang, Yingying Yan, Xiaodong Guan, Suodi Zhai, Kehu Yang Tags: Review Source Type: research
Few randomized trials in preterm birth prevention meet predefined usefulness criteria
We operationalized a research usefulness tool identified through literature searches and consensus and examined if randomized controlled trials (RCTs) addressing preterm birth prevention met predefined criteria for usefulness. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - August 29, 2023 Category: Epidemiology Authors: Janneke van ‘t Hooft, Charlotte E. van Dijk, Cathrine Axfors, Zarko Alfirevic, Martijn A. Oudijk, Ben W.J. Mol, Patrick M. Bossuyt, John P.A. Ioannidis Tags: Original Article Source Type: research
Few randomised trials in preterm birth prevention meet predefined usefulness criteria
We operationalized a research usefulness tool identified through literature searches and consensus and examined if randomised controlled trials (RCTs) addressing preterm birth prevention met predefined criteria for usefulness. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - August 29, 2023 Category: Epidemiology Authors: Janneke van ‘t Hooft, Charlotte E. van Dijk, Cathrine Axfors, Zarko Alfirevic, Martijn A. Oudijk, Ben W.J. Mol, Patrick M. Bossuyt, John P.A. Ioannidis Tags: Original Article Source Type: research
Replication of Systematic Reviews: Is It to the Benefit or Detriment of Methodological Quality?
To perform an overview of the overlap of systematic reviews (SR) assessing direct oral anticoagulants (DOACs) and characterise these reviews in terms of bias and methodological quality (PROSPERO: CRD42022316273). (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - August 28, 2023 Category: Epidemiology Authors: C éline Chapelle, Edouard Ollier, Paul Bonjean, Clara Locher, Paul Jacques Zufferey, Michel Cucherat, Silvy Laporte Tags: Original Article Source Type: research
Leading pharmaceutical companies lacked transparency on clinical trials ’ informed consent forms
(Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - August 28, 2023 Category: Epidemiology Authors: Rafael Dal-R é, Teck Chuan Voo, Søren Holm Tags: Letter to the Editor Source Type: research
Prospective collaborative recommendation development: A novel model for more timely and trustworthy guidelines
(Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - August 28, 2023 Category: Epidemiology Authors: Elie A. Akl, Adam Cuker, Reem A. Mustafa, Robby Nieuwlaat, Adrienne Stevens, Holger Sch ünemann Tags: Commentary Source Type: research
Underrecording and underreporting of participant ethnicity in clinical trials is persistent and is a threat to inclusivity and generalizability
People from ethnic minority groups are underserved by randomized trials, and poor representation of these groups reduces generalizability of results. There is no guidance on which ethnicity categories are appropriate for use in trials and thus inconsistency exists. The purpose of this study is to establish, in a large sample of trials, if participant ethnicity is recorded, how it is obtained (categories used), and if its reporting varies from its recording. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - August 25, 2023 Category: Epidemiology Authors: Neil Wallace, Stacey O'Keeffe, Heidi Gardner, Frances Shiely Tags: Methodological Considerations Related to Equity, Diversity, and Inclusion in Clinical Epidemiology Source Type: research
Under-recording and under-reporting of participant ethnicity in clinical trials is persistent and is a threat to inclusivity and generalisability
People from ethnic minority groups are under-served by randomised trials, and poor representation of these groups reduces generalisability of results. There is no guidance on which ethnicity categories are appropriate for use in trials and thus inconsistency exists. The purpose of this study is to establish, in a large sample of trials, if participant ethnicity is recorded, how it is obtained (categories used), and if its reporting varies from its recording. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - August 25, 2023 Category: Epidemiology Authors: Neil Wallace, Stacey O ’Keeffe, Heidi Gardner, Frances Shiely Tags: Original Article Source Type: research
The Estimand Framework had Implications in Time to Patient-Reported Outcomes Deterioration Analyses in Cancer Clinical Trials
To apply the estimand framework in time to deterioration (TTD) analysis of patient-reported outcomes (PROs), and identify the appropriate statistical methods to deal with intercurrent event (IEs) such as death. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - August 25, 2023 Category: Epidemiology Authors: Francesco Cottone, Fabio Efficace, David Cella, Neil K. Aaronson, Johannes M. Giesinger, Jean-Baptiste Bachet, Christophe Louvet, Emilie Charton, Gary S. Collins, Amelie Anota Tags: Original Article Source Type: research
No evidence of important difference in summary treatment effects between COVID-19 preprints and peer-reviewed publications: a meta-epidemiological study
Preprints became a major source of research communication during the COVID-19 pandemic. We aimed to evaluate whether summary treatment effect estimates differ between preprint and peer-reviewed journal trials. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - August 25, 2023 Category: Epidemiology Authors: Mauricia Davidson, Theodoros Evrenoglou, Carolina Gra ña, Anna Chaimani, Isabelle Boutron Tags: Original Article Source Type: research
Depression Screening Tool Accuracy Individual Participant Data Meta-analyses: Data Contribution was Associated with Multiple Factors
To examine the proportion of eligible primary studies that contributed data, study characteristics associated with data contribution, and reasons for non-contribution using diagnostic test accuracy individual participant data meta-analysis (IPDMA) datasets from the DEPRESsion Screening Data project. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - August 22, 2023 Category: Epidemiology Authors: Yin Wu, Ying Sun, Yi Liu, Brooke Levis, Ankur Krishnan, Chen He, Dipika Neupane, Scott B. Patten, Pim Cuijpers, Roy C. Ziegelstein, Andrea Benedetti, Brett D. Thombs Tags: Original Article Source Type: research
GRADE guidance 23: Considering cost-effectiveness evidence in moving from evidence to health-related recommendations
This is the 23rd in a series of articles describing the GRADE approach to grading the certainty of evidence and strength of recommendations for systematic reviews, health technology assessments, and clinical guideline development. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - August 17, 2023 Category: Epidemiology Authors: Feng Xie, Ian Shemilt, Luke Vale, Francis Ruiz, Michael F. Drummond, Joanne Lord, Kirsten H. Herrmann, Mar ía Ximena Rojas, Yuan Zhang, Carlos Canelo-Aybar, Pablo Alonso-Coello, Tatyana Shamliyan, Holger J. Schünemann, GRADE Working Group Tags: Original Article Source Type: research
Metaresearch study highlights the gender gap in randomized controlled trials in dentistry
This study aimed to assess the gender gap in randomized controlled trials (RCTs) in dentistry in terms of authorship, collaborations, metrics, funding and reporting of good research practice and transparecy. (Source: Journal of Clinical Epidemiology)
Source: Journal of Clinical Epidemiology - August 11, 2023 Category: Epidemiology Authors: Mayara Colpo Prado, Lara Dotto, Bernardo Antonio Agostini, Rafael Sarkis-Onofre Tags: Methodological Considerations Related to Equity, Diversity, and Inclusion in Clinical Epidemiology Source Type: research
