Reporting of adverse events and statistical details of efficacy estimates in randomized clinical trials of pain in temporomandibular disorders

Gewandter, Jennifer S.; Smith, Shannon M.; McKeown, Andrew; Edwards, Kenessa; Narula, Aastha; Pawlowski, Joseph R.; Rothstein, Donna S.; Desjardins, Paul J.; Dworkin, Samuel F.; Gross, Robert A.; Ohrbach, Richard; Rappaport, Bob A.; Sessle, Barry J.; Turk, Dennis C.; Dworkin, Robert H.

doi:10.1016/j.adaj.2014.12.023

Cited by 9 publications

(4 citation statements)

References 36 publications

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“…Ideally, randomised controlled trials should evaluate not only potential benefits of interventions, but also potential harms. However, these trials are often limited in their ability to evaluate harms because of the short duration of intervention and follow-up, restricted study populations (eg, excluding participants with comorbidities or receiving cointerventions), and lack of statistical power to assess rare events 1234. Nevertheless, prospectively collected data about harms in randomised controlled trials are important to inform knowledge synthesis and patient and provider decisions.…”

mentioning

confidence: 99%

CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials

Junqueira

Zorzela

Golder

et al. 2023

BMJ

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Randomised controlled trials remain the reference standard for healthcare research on effects of interventions, and the need to report both benefits and harms is essential. The Consolidated Standards of Reporting Trials (the main CONSORT) statement includes one item on reporting harms (ie, all important harms or unintended effects in each group). In 2004, the CONSORT group developed the CONSORT Harms extension; however, it has not been consistently applied and needs to be updated. Here, we describe CONSORT Harms 2022, which replaces the CONSORT Harms 2004 checklist, and shows how CONSORT Harms 2022 items could be incorporated into the main CONSORT checklist. Thirteen items from the main CONSORT were modified to improve harms reporting. Three new items were added. In this article, we describe CONSORT Harms 2022 and how it was integrated into the main CONSORT checklist, and elaborate on each item relevant to complete reporting of harms in randomised controlled trials. Until future work from the CONSORT group produces an updated checklist, authors, journal reviewers, and editors of randomised controlled trials should use the integrated checklist presented in this paper.

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mentioning

confidence: 99%

CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials

Junqueira

Zorzela

Golder

et al. 2023

BMJ

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“…In preparation for developing this checklist, the authors reviewed a diverse set of published recommendations and systematic reviews that addressed the reporting of clinical trials, including those related to all therapeutic indications 1,12,13,22,30,33,34,43,44 and those specific to pain clinical trials. 8,10,11,14,19,21,37–41 The checklist was modified multiple times based on the input from all authors as well as the editors of this series. Examples were developed based on hypothetical protocols; although they may include elements of existing studies, they are not based largely on any particular example from the literature.…”

Section: Methodsmentioning

confidence: 99%

“…A decade after the publication of the first CONSORT guidelines, systematic reviews of clinical trials in the pain field identified a number of common deficiencies in reporting of clinical trials, including failure to identify primary outcome measures and analyses, indicate clearly the numbers of participants who completed the trial and were included in the analyses, or report harms adequately. 8,15,16,18,19,21,38–40 In this article, we describe a checklist (Table 2) designed to supplement the content covered in the CONSORT checklist with added details relating to challenges specific to pain trials or found to be poorly reported in recent pain trials. We have not included areas for which reporting has been found to be poor in pain trials when further expansion of the CONSORT checklist seems unlikely to improve reporting (eg, harms reporting 23 ).…”

Section: Introductionmentioning

confidence: 99%

Checklist for the preparation and review of pain clinical trial publications: a pain-specific supplement to CONSORT

Gewandter

Eisenach

Gross

et al. 2019

PR9

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“…The assessment, analysis, and reporting of adverse events are critical components of every clinical trial. 8 In the absence of these data, determining the treatment's risk profile becomes challenging 140 Indeed, a systematic review that assessed the reporting of adverse effects in RCTs of pain in temporomandibular disorders (TMD) found that adverse events information was generally poorly reported in the TMD articles and that authors reported adverse events occurring within each treatment group in only 36% of older articles and 39% of newer articles. 140 One important limitation of this review is the considerable time elapsed between the databases searches and its completion.…”

Section: Device Measurement Outcomesmentioning

confidence: 99%

Synthesis of temporomandibular disorders management intervention outcomes for development of core outcome sets: A systematic review

Ferreira,

Marto,

de Sousa

et al. 2024

J of Oral Rehabilitation

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IntroductionThe selection of appropriate outcomes in clinical trials and systematic reviews is a crucial factor in determining the results that are useful, reliable, and relevant for both patients and healthcare professionals. Clinicians and researchers have been encouraged to develop and apply core outcome sets (COS) to minimise the discrepancy between studies.AimThis systematic review is the first phase of the COS development project for clinical trials in temporomandibular disorders (COS‐TMD). It aims to identify and synthesise the outcomes used in the randomised controlled trials (RCT) that evaluated the effectiveness of interventions used in TMD management.Materials and MethodsAn electronic search was performed in several databases: MEDLINE (via PubMed), Scopus, Web of Science, Cochrane Library and EMBASE. The eligibility criteria comprised RCT that applied any intervention to treat temporomandibular joint disorders or masticatory muscle disorders. The identified outcomes were categorised according to domains of the Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT).ResultsThe electronic search resulted in 1606 studies. After removing duplicates and applying the eligibility criteria, 106 RCT were included. A total of 43 studies evaluated masticatory muscle disorders, 27 evaluated temporomandibular joint disorders, and 36 analysed mixed TMD.ConclusionsThe evaluation showed significant variability in the types of outcomes and their measurement instruments. In addition, some domains such as physical and emotional functioning, participant ratings of global improvement and adverse events have been neglected when determining the effectiveness of treatments for TMD.

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Reporting of adverse events and statistical details of efficacy estimates in randomized clinical trials of pain in temporomandibular disorders

Cited by 9 publications

References 36 publications

CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials

CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials

Checklist for the preparation and review of pain clinical trial publications: a pain-specific supplement to CONSORT

Synthesis of temporomandibular disorders management intervention outcomes for development of core outcome sets: A systematic review

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