Page 36 - Demo
P. 36


                                    Chapter 234time limit for the second search strategy in EMBASE of the last 10 years was applied due to the large amount of articles. Additional articles were identified by scoping search (n = 15), reference list checking and citation tracking (n = 59), and contacting authors of relevant articles (n = 6). All searches were conducted by the librarian and 1 reviewer (A.R.M.).Rayyan (an application for systematic reviews) was used for screening.22 All titles and abstracts were screened for relevance by 4 reviewers (A.M.v.E., M.M.M.G.B., E.B., and A.R.M.) with a subsample of 10% screened for interrater reliability. Interrater reliability analysis using the Cohen kappa statistic was performed to determine consistency between raters. Full texts were screened against inclusion and exclusion criteria, and data were independently extracted by at least 2 reviewers, of whom 1 (A.R.M.) covering all studies. Discrepancies were discussed until consensus was reached.To provide guidance for appraisal of the quality of reporting of the full text publications and methodology, the Consolidated Standards of Reporting Trials (CONSORT) extension for reporting N-of-1 Trials (CENT) 20156,23 and the Risk of Bias in N-of-1 Trials (RoBiNT) Scale15 were scored. The CENT 2015 reporting standard consists of 25 items including recommendations about what to report and covers optimal methodology of medical and behavioral sciences. The RoBiNT Scale consists of 15 items including subscales on internal and external validity and evaluates how well a particular component of a study is conducted. The internal validity scale of the RoBiNT consists of 7, and the external validity and interpretation scale of 8 items, with a maximum score of 14 and 16 points, respectively.Data ExtractionData were extracted on first author, year of publication, countries of study, number of participants, diagnosis, patient characteristics (age, presence/absence of ID, level of ID, Full Scale Intelligence Quotient, psychiatric diagnosis, comorbidities, and concurrent therapies), selection criteria, institutional ethical approval, trial design, run-in and washout periods, number of trial conditions, number and duration of periods, randomization, blinding, crossover trials, intervention(s), total intervention duration, comparator used, outcome assessment, major organ system studied, primary/secondary outcome measure(s) (presence and type), adverse events, power analysis, Annelieke Muller sHL.indd 34 14-11-2023 09:07
                                
   30   31   32   33   34   35   36   37   38   39   40