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

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          Use of this checklist by authors and reviewers will improve quality and transparency in reporting randomized clinical trials of pain treatments.



          Randomized clinical trials (RCTs) are considered the gold standard when assessing the efficacy of interventions because randomization of treatment assignment minimizes bias in treatment effect estimates. However, if RCTs are not performed with methodological rigor, many opportunities for bias in treatment effect estimates remain. Clear and transparent reporting of RCTs is essential to allow the reader to consider the opportunities for bias when critically evaluating the results. To promote such transparent reporting, the Consolidated Standards of Reporting Trials (CONSORT) group has published a series of recommendations starting in 1996. However, 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 (eg, 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).


          To provide a reporting checklist specific to pain clinical trials that can be used in conjunction with the CONSORT guidelines to optimize RCT reporting.


          Qualitative review of a diverse set of published recommendations and systematic reviews that addressed the reporting of clinical trials, including those related to all therapeutic indications (eg, CONSORT) and those specific to pain clinical trials.


          A checklist 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 was developed.


          Authors and reviewers of analgesic RCTs should consult the CONSORT guidelines and this checklist to ensure that the issues most pertinent to pain RCTs are reported with transparency.

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          Most cited references 27

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          Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials.

          To determine if inadequate approaches to randomized controlled trial design and execution are associated with evidence of bias in estimating treatment effects. An observational study in which we assessed the methodological quality of 250 controlled trials from 33 meta-analyses and then analyzed, using multiple logistic regression models, the associations between those assessments and estimated treatment effects. Meta-analyses from the Cochrane Pregnancy and Childbirth Database. The associations between estimates of treatment effects and inadequate allocation concealment, exclusions after randomization, and lack of double-blinding. Compared with trials in which authors reported adequately concealed treatment allocation, trials in which concealment was either inadequate or unclear (did not report or incompletely reported a concealment approach) yielded larger estimates of treatment effects (P < .001). Odds ratios were exaggerated by 41% for inadequately concealed trials and by 30% for unclearly concealed trials (adjusted for other aspects of quality). Trials in which participants had been excluded after randomization did not yield larger estimates of effects, but that lack of association may be due to incomplete reporting. Trials that were not double-blind also yielded larger estimates of effects (P = .01), with odds ratios being exaggerated by 17%. This study provides empirical evidence that inadequate methodological approaches in controlled trials, particularly those representing poor allocation concealment, are associated with bias. Readers of trial reports should be wary of these pitfalls, and investigators must improve their design, execution, and reporting of trials.
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            Systematic reviews in health care: Assessing the quality of controlled clinical trials.

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              The fibromyalgia impact questionnaire: development and validation.

              An instrument has been developed to assess the current health status of women with the fibromyalgia syndrome. The Fibromyalgia Impact Questionnaire (FIQ) is a brief 10-item, self-administered instrument that measures physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well being. We describe its development and validation. This initial assessment indicates that the FIQ has sufficient evidence of reliability and validity to warrant further testing in both research and clinical situations.

                Author and article information

                Pain Rep
                Pain Rep
                Pain Reports
                Wolters Kluwer (Philadelphia, PA )
                May-Jun 2019
                09 May 2018
                : 4
                : 3
                [a ]Department of Anesthesiology, University of Rochester, Rochester, NY, USA
                Departments of [b ]Anesthesiology and Physiology and
                [c ]Pharmacology, Wake Forest, Winston-Salem, NC, USA
                Departments of [d ]Neurology and Pharmacology and
                [e ]Physiology, University of Rochester, Rochester, NY, USA
                [f ]Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA
                Departments of [g ]Psychiatry and Behavioral Science and
                [h ]Psychology and Neuroscience, Duke University, Durham, NC, USA
                [i ]Seattle, WA, USA
                [j ]Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA
                Author notes
                [* ]Corresponding author. Address: Department of Anesthesiology, University of Rochester, Rochester, NY 14642, USA. Tel.: +1 585 276 5661; fax: +1 585 244 7271. E-mail address: jennifer_gewandter@ 123456urmc.rochester.edu (J.S. Gewandter).
                PAINREPORTS-D-17-0030 00037
                Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.

                This is an open access article distributed under the Creative Commons Attribution-NoDerivatives License 4.0 (CC BY-ND) which allows for redistribution, commercial and non-commercial, as long as it is passed along unchanged and in whole, with credit to the author.

                ACTTION Special Issue on Clinical Trials of Pain Treatments
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