Compliance of published randomized controlled trials on the effect of physical activity on primary dysmenorrhea with the consortium's integrated report on clinical trials statement: A critical appraisal of the literature

Abstract

Background: Randomized Controlled Trials (RCTs) are reliable methods for the evaluation of treatment effectiveness, which should be rigorous and must report with clarity. This study aimed to assess the compliance of published RCTs about the effect of physical activity on primary dysmenorrhea with the CONSORT 2017 statement. Materials and Methods: In this study, the review of literature was carried out based on Consolidated Standards Of Reporting Trials (CONSORT). All the clinical trials focused on the effect of the physical activity on primary dysmenorrhea indexed in Web of Science, Pubmed, Scopus, Google Scholar, Science Direct, Embase, Magiran and Scientific Information Database (SID) were searched using keywords of dysmenorrhea, randomized clinical trial, physical activity and exercise from 2000 to 2019. Out of 1423 articles, 30 RCTs were critically appraised using CONSORT 2017 checklist. The reporting quality score of articles was identified between zero and 43. Results: The compliance rate with the CONSORT checklist was 55.58%. The mean (SD) score of the reporting quality was 23.37 (-5.15) with a minimum of 16 and a maximum of 37. The maximum weakness was in reporting the sample size and full trial protocol 23.33% and 6.67% respectively. Regarding new items of the consort 2017, if the blinding was not possible, the description of any attempts to limit bias was not described in 70% of articles. Conclusions: Reporting sample size, trial protocol, method of blinding, and control of bias are issues that require more attention in reporting of RCT studies. We recommend that the authors use the CONSORT 2017 statement for conducting and reporting the clinical trials.

Comparative Effectiveness of Different Exercises for Reducing Pain Intensity in Primary Dysmenorrhea: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials

“…This evaluation was performed using the previously mentioned databases to meticulously review potential trials. In addition to electronic searches, the reference lists of several review articles [13,14,[31][32][33][34][35][36] were also meticulously perused, and manual searches were conducted to ensure comprehensive coverage. In instances where the initial two reviewers encountered difficulties in achieving a consensus, a third reviewer and co-author of the study (Chang KV) was engaged for arbitration.…”

Qualidade Dos Relatos De Ensaios Clínicos Randomizados Sobre Realidade Virtual Durante Punção/Cateterismo Intravenoso Periférico

“…Na primeira etapa deste estudo, elaborou-se protocolo baseado nos parâmetros de qualidade do Prisma-P (Preferred Reporting Items for Systematic review and Meta-Analysis Protocols) 11 O título, que corresponde ao item 1a, não apresentou o termo "ensaio clínico randômico" em três artigos [19][20][21] . Esta recomendação se embasa na necessidade de identificar e indexar de forma adequada estes estudos em bases eletrônicas, evitando que sejam classificados inapropriadamente [7][8]22 , achado também encontrado em outras duas pesquisas sobre avaliação de itens contemplados do CONSORT 7,14,24 , em que menos de 50% identificou corretamente o título. Porém, a identificação do tipo de estudo no título pode vir a ser suprimido, devido ao número de palavras solicitadas pelas regras de formação do periódico.…”

“…Também, não foi considerado o item 17b, pois refere-se a desfechos binários, que não foram utilizados nos estudos em questão. Já o item 25 foi retirado, pois nem (≤ 8), mediano(9)(10)(11)(12)(13)(14)(15)(16), bom(17)(18)(19)(20)(21)(22)(23)(24) e excelente (25-32).Após a verificação dos artigos pelos dois avaliadores, realizou-se reunião de consenso, no intuito de analisar os dados e verificar a concordância ou discordância entre eles quanto à análise dos itens que atendiam ao CONSORT7 .Para avaliar esta concordância, empregou-se análise estatística descritiva e inferencial, sendo aplicado o Teste Kappa 15 , por meio do Programa IBM SPSS Statistcs 22. Os resultados encontrados foram 291 artigos, sendo 35 duplicatas.…”