BackgroundTitles and abstracts are the most read sections of biomedical papers. It is therefore important that abstracts transparently report both the beneficial and adverse effects of health care interventions and do not mislead the reader. Misleading reporting, interpretation, or extrapolation of study results is called “spin”. In this study, we will assess whether adverse effects of orthodontic interventions were reported or considered in the abstracts of both Cochrane and non-Cochrane reviews and whether spin was identified and what type of spin.MethodsEligibility criteria were defined for the type of study designs, participants, interventions, outcomes, and settings. We will include systematic reviews of clinical orthodontic interventions published in the five leading orthodontic journals and in the Cochrane Database. Empty reviews will be excluded. We will manually search eligible reviews published between 1 August 2009 and 31 July 2019. Data collection forms were developed a priori. All study selection and data extraction procedures will be conducted by two reviewers independently. Our main outcomes will be the prevalence of reported or considered adverse effects of orthodontic interventions in the abstract of systematic reviews and the prevalence of “spin” related to these adverse effects. We will also record the prevalence of three subtypes of spin, i.e., misleading reporting, misleading interpretation, and misleading extrapolation-related spin. All statistics will be calculated for the following groups: (1) all journals individually, (2) all journals together, and (3) the five leading orthodontic journals and the Cochrane Database of Systematic Reviews separately. Generalized linear models will be developed to compare the various groups.DiscussionWe expect that our results will raise the awareness of the importance of reporting and considering of adverse effects and the presence of the phenomenon of spin related to these effects in abstracts of systematic reviews of orthodontic interventions. This is important, because an incomplete and inadequate reporting, interpretation, or extrapolation of findings on adverse effects in abstracts of systematic reviews can mislead readers and could lead to inadequate clinical practice. Our findings could result in policy implications for making judgments about the acceptance for publication of systematic reviews of orthodontic interventions.
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.
Angular changes in taking periapical radiographs of mandibular incisors and the presence of brackets significantly affect interproximal enamel measurements made with image analysis software.
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