ObjectiveTo acquaint the development process and item composition of the appraisal tools and reporting standards of clinical pathways worldwide, in order to improve the development and evaluation of clinical pathways. MethodsWe searched databases including PubMed, EMbase, Web of Science, CBM, CNKI and WanFang Data for articles about the appraisal tools and reporting standards of clinical pathways from inception to Jan, 2014. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and compared the difference in development process and item composition among included appraisal tools and reporting standards of clinical pathways. ResultsA total of 7 appraisal tools and reporting standards were included. Among them, 3 were from UK, 1 from China, 1 from Australia, 1 from Belgium, and 1 from Saudi Arabia. All included appraisal tools contained 4 to 15 domains and 14 to 99 items. Based on the comparison of different domains and items of included appraisal tools, "Clinical Pathway Management Guidelines" published by the National Health and Family Planning Commission of the People's Republic of China and the research of Vannhaecht, we identified 17 key elements of clinical pathway as follows:organizational commitment, pathway project management, format of doc, content of pathway, multidisciplinary involvement, variance management, EBM/guidelines, maintenance of pathway, accountability, patient involvement, development of pathway, additional support systems & documents, operational arrangement, implementation, outcome management, safety and organization of the care process. ConclusionCurrently, the appraisal tools and reporting standards of clinical pathways are rudimentary, so we desperately needs to establish mature appraisal tool and reporting standard of clinical pathways to guide the development and implementation of clinical pathway, so as to improve their application effects in clinical practice and medical quality.
Reporting standard system of clinical research of traditional Chinese medicine (TCM) is composed of ten reporting standards in the areas of the design and preparation of TCM clinical researches, researches of different types, randomized controlled trials of various interventions, systematic reviews of the trials and the translation of research evidence, which were developed by different research groups. This article systematically analyzed the current reporting standards of clinical research of TCM. Achievements and problems were found in the review so as to provide insights for the ongoing reporting standards and to assist the construction of the reporting standard system so as to improve the reporting quality of clinical researches of TCM.
According to the evidence pyramid model, systematic review (SR)/meta-analysis (MA) is one of the essential sources with a high level of clinical evidence. A high-quality SR/MA can effectively guide clinical decision-making and practice. The preferred reporting items for systematic reviews and meta-analyses extension for Chinese herbal medicines (PRISMA-CHM) were officially published in 2020. In this study, based on research cases, the features of PRISMA-CHM were interpreted in detail, so as to help domestic users accurately grasp the details of the reports, in order to improve the quality of the reports of SR/MA of traditional Chinese medicine.
Digital health technology implementation has grown rapidly in recent years. To standardize the quality of digital health implementation research and increase the transparency and integrity of reporting, Perrin published iCHECK-DH: guidelines and checklist for the reporting on digital health implementations in 2023. This article interprets the contents of the list with a view to improving the reporting quality of digital implementation studies to develop more effective digital health interventions and achieve better health outcomes.
To enhance the quality and transparency of oncology real-world evidence studies, the European Society for Medical Oncology (ESMO) has developed the first specific reporting guidelines for oncology RWE studies in peer-reviewed journals ‘the ESMO Guidance for Reporting Oncology Real-World Evidence (GROW)’. To facilitate readers understanding and application of these reporting standards, this article introduces and interprets the development process and main content of the ESMO-GROW checklist.
The complete, transparent, and standardized reporting of the outcome of a clinical trial is a key factor in ensuring the practicality, reproducibility, and transparency of the trial, and reducing bias in selective reporting. The Consolidated Standards of Reporting Trials (CONSORT) 2010 statement provides normative guidelines for the reporting of clinical trials. In December 2022, JAMA released the Guidelines for Reporting Outcomes in Trial Reports (CONSORT-Outcomes) 2022 Extension, aiming to explain the entries related to trial outcomes, sample size, statistical methods, and auxiliary analysis in the CONSORT 2010 statement, to further improve the standards for outcome reporting in clinical trial reports. This article combines research examples to interpret the CONSORT-Outcomes 2022 Extension, in order to provide normative references for domestic scholars to report clinical research results.
Transparent reporting of randomized trials is essential to facilitate critical appraisal and interpretation of results. Factorial trials, in which two or more interventions are assessed in the same set of participants, have unique methodological considerations. However, reporting of factorial trials is suboptimal. A consensus-based extension to the consolidated standards of reporting trials (CONSORT) 2010 statement for factorial trials was developed based on the enhancing the quality and transparency of health research (EQUATOR) methodological framework. In the study, we introduced and interpreted the extension of the CONSORT 2010 statement for factorial design in which 16 items were modified and one new item was added and presented an example of a factorial trial in mental health to provide guidance on the reporting of factorial randomized trials.