Seeking adverse effects in systematic reviews of orthodontic interventions: protocol for a cross-sectional study

Abstract

Background Before implementing healthcare interventions, clinicians need to weigh the beneficial and adverse effects of interventions. However, a large body of evidence has demonstrated that seeking and reporting of adverse effects is suboptimal in clinical trials and in systematic reviews of interventions. This cross-sectional study will investigate the status of this problem in orthodontics. This study will assess whether adverse effects were sought and whether findings related to adverse effects were reported in systematic reviews of orthodontic interventions in the five leading orthodontic journals and in the Cochrane Database of Systematic Reviews. Methods Systematic reviews of clinical orthodontic interventions published between 01 August 2009 and 31 July 2019 in the five leading orthodontic journals and in the Cochrane Database will be included. Empty reviews will be excluded. The reporting of outcomes on adverse effects will not determine eligibility, i.e., reviews will not be excluded, because they did not report usable data. Study selection and data extraction will be conducted independently by two authors. Our primary outcome will be the prevalence of systematic reviews of orthodontic interventions that sought any findings related to adverse effects in the included studies. Additional prevalence statistics will be calculated on a series of items related to seeking of adverse effects in the eligible reviews. All statistics will be calculated for (1) all journals together, (2) the group of five orthodontic journals and the Cochrane Database of Systematic Reviews separately, and (3) each individual journal separately. Chi-square tests of independence will be used to compare these groups. Discussion This study will assess whether adverse effects were sought in systematic reviews of orthodontic interventions. This knowledge is important, because reviews that present an incomplete picture on adverse effects can have unfavorable consequences for the end-users. Also not reporting that no adverse effects were assessed in eligible studies included in a systematic review can mislead pertinent stakeholders. Our findings could have policy implications for making judgments on accepting or rejecting an intervention systematic review for publication, for example, by directing editors and peer-reviewers to adopt the various items on adverse effects defined in the MECIR standards and in the PRISMA harm checklist. Electronic supplementary material The online version of this article (10.1186/s13643-019-1000-1) contains supplementary material, which is available to authorized users.

Spin in the reporting, interpretation, and extrapolation of adverse effects of orthodontic interventions: protocol for a cross-sectional study of systematic reviews

“…We adopted the same flow of research methods as reported in our published protocol on seeking adverse effects in systematic reviews of orthodontic interventions (Fig. 1) and conducted our pilot tests on the same sample of systematic reviews as was described in our previous protocol [15]. Our sample size of 14 reviews for the pilot test was calculated with the formula reported by Viechtbauer et al [29].…”

“…1Flow diagram of the research methods. “Flow diagram of the research methods” was published previously by Steegmans et al [15] in the journal “Systematic Reviews,” which is an open access journal of BioMed Central. Copyright on any open access article in a journal published by BioMed Central is retained by the author(s)…”

“…We will adopt the same eligibility criteria that were defined for our published protocol on seeking adverse effects in systematic reviews of orthodontic interventions [15]. To avoid misinterpretation, we copied and pasted these eligibility criteria into Table 3 [15, 30].…”

“…Eligible search terms were identified through searches in thesauri and in key articles on adverse effects [13, 36–40]. These terms are given in Additional file 3 and are identical to those used in our protocol on seeking adverse effects in systematic reviews of orthodontic interventions [15]. Our pilot-tested data collection forms will be used for all data extraction procedures (Additional file 4).…”

“…We adopted Cochrane’s definition of adverse effects: “An adverse event for which the causal relation between the intervention and the event is at least a reasonable possibility” [12, 13]. This definition and other key terminology in this manuscript are summarized in Table 1 [2–4, 12–15].…”