Implementation science is a relatively emergent and growing research area. Implementation research can assist to transform what is possible in theory to reality in practice and address the challenge of implementing proven interventions in the real world. Implementation research has a wide range of usages and complex research problems, so appropriate research methods, designs, and outcomes variables are required to address different research objectives. To better conduct implementation research, this paper systematically introduces the research designs, outcome variables, and reporting guideline of the implementation research in health care, based on the purposes and research questions of implementation research.
Objective To evaluate the quality of randomized controlled trials (RCTs) of traditional Chinese medicine published inChinese Journal of Integrated Traditional and Western Medicine, and to analyze changes. Methods We searched CNKI to collect RCTs published inChinese Journal of Integrated Traditional and Western Medicine (CJITWM) in 2014. Reporting quality of RCTs was evaluated by using CONSORT 2010 checklist, the methodological quality and ethics requirements were also analyzed. The changes of quality was also analyzed by comparing with those of 2004. Results A total of 80 RCTs were included. The top three interventions were Chinese patent medicine, decoction, acupuncture. Items with high reporting rate (>80%) included abstract, participants, randomization sequences and informed consent. Items with reporting rate of 50% to 80% including introduction, interventions, harms and funding, and others were all less than 50%. Among them, the reporting quality of title, trial design, outcomes, sample size, type of randomization, allocation concealment, blinding, numbers analyzed, outcomes and estimation, generalizability, interpretation, registration and protocol was less than 10%. Compared with those of 2004, the quality of reporting, methodology, and ethics has all increased. Significant progress was made in items of structured summary, background and objectives, collecting participants, adverse reactions, quality control standards of TCM interventions, diagnostic evaluation criteria of TCM, follow-up, funding, ethical approval and informed consent. But small progress was made in randomization, allocation concealment and implementation, sample size, blinding and ITT. There has been no participant flow. Conclusion The quality of reporting, methodology, and ethics of RCTs published inChinese Journal of Integrated Traditional and Western Medicine have made some progress, however, trial design, outcomes selection, estimation of sample size, randomization, blinding, registration and participant flow are still needed to be further improved.
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.
ObjectiveTo assess the methodological and reporting quality of systematic reviews/Meta-analyses (SRs/MAs) of transurethral procedure for benign prostatic hyperplasia (BPH). MethodWe electronically searched databases including PubMed, The Cochrane Library (Issue 12, 2014), Sciverse, CNKI, VIP and WanFang Data from inception to December 2014 to collect SRs/MAs of transurethral procedure about BPH. Two reviewers independently screened literature and assessed the methodological and reporting quality of included SRs/MAs by AMSTAR and PRISMA checklists. ResultsA total of 33 SRs/MAs were included. The results of qualitative analysis showed that:the main methodological weakness of included SRs/MAs included the lack of protocol, disappropriate conclusion formulation, the lack of publication bias assessment, and the lack of stating the conflict of interest. The average score of AMSTAR scale was 6.27±2.14. There were 11 items in PRISMA checklist with coincidence rate over 80%, 8 items between 50% to 80%, and 8 items less than 50%. ConclusionThe methodological and reporting quality of SR/MA of transurethral procedure for BHP is low, and that may decrease the reliability and value of results from SRs/MAs in the field. Future SRs/MAs should strictly follow the related reporting guidelines in order to improve the methodological and reporting quality, so as to provide more reliable evidence for clinical decision.
To solve the problems such as the incomplete and non-standard reporting outcomes in clinical trials, international methodologists have simultaneously launched guidelines for reporting outcomes in trial protocols and reports in 2022 on the basis of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 and the Consolidated Standards of Reporting Trials (CONSORT) statement 2010. The SPIRIT-Outcomes 2022 extension and CONSORT-Outcomes 2022 extension recommend outcome-specific reporting items should be included prospectively in trial protocols and reports, regardless of trial design or population. This paper introduces and interprets the two guidelines for reporting outcomes, and discusses their significance and enlightenment to the research in the field of traditional Chinese medicine. For example, using the outcome reporting guidelines will help clinical researchers comprehensively consider issues related to outcomes when reporting protocols or results, which may improve the quality of research design and reporting. For core outcome set, the five core elements of outcomes may help researchers extracting and analyzing outcomes, which will standardize research; the explanation of medical terminology in the outcome reporting guidelines will contribute to the improvement of methodology in the field of traditional Chinese medicine.
In recent years, the potential value of clinical big data have been gradually realized, and disease prediction models have begun to become a hot spot in clinical research. Predictive models of different types of diseases play an increasingly important role in individual risk assessment. However, due to the lack of reporting specifications for studies on disease prediction model, the structure and quality of reports are mostly mixed. In 2015, BMJ published a paper entitled "Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): the TRIPOD statement" stated that there should be a uniform study of predictive models for disease diagnosis and prognosis. This article interprets key contents of the statement to promote research and understanding of the report specification.
ObjectivesUsing the ARRIVE guidelines (Animal Research Reporting: In Vivo Experiments Guidelines) to carry out a retrospective study of the reporting quality of animal studies published in Chinese journals.MethodsWe searched databases including CNKI, WanFang Data, VIP and CBM to July, 2018. Four reviewers independently screened literatures and extracted data. The ARRIVE guidelines were used to assess reporting quality and the comparative analysis based on different published time.ResultsA total of 4 342 studies were included. About the cited frequency, 73.03% studies were ≤5, and merely 29.04% studies were published in journals of CSCD. The assessment results showed that the number of reported items with "low risk" in the ARRIVE guidelines, which have 20 items, that meaning 39 sub items, more than half of sub items (51.28%, 20/39) rated as "low risk" had a compliance rate of less than 50%. Among them, 65.00% (13/20) of sub items had a lower rate of compliance with "low risk" than 10%.ConclusionThe reporting quality of domestic animal studies is generally low. The coincidence rate of domestic animal studies has been improved to some extent in most of items after the ARRIVE guidelines published, however, some items of methodology, results and conclusions had problems with insufficient reporting. Therefore, we suggest that it is necessary to popularize the ARRIVE guidelines, advocate more researchers following the ARRIVE guidelines and promote endorsement of the ARRIVE Guideline by Chinese Journals to improve the design, implementation and reporting of animal experiments, and ultimately enhance the quality of animal studies.
Objective To assess the reporting quality of noninferiority and equivalence randomized controlled trials (RCTs) related to Traditional Chinese Medicine (TCM). Methods The noninferiority and equivalence RCTs related to TCM were searched, and the quality of the included RCTs was identified in accordance with the extended version of CONSORT statement which refers to the reporting standard of noninferiority and equivalence RCTs. Results A total of 13 noninferiority and equivalence RCTs were included. Except for the common questions of RCTs in reporting quality, some contents related to noninferiority and equivalence trials in reporting were not enough: a) The title of RCTs did not reflect the most important content of the literature; b) The introduction of background was quite simple. The rationale about noninferiority and equivalence trials, and the effectiveness of positive control were not clearly defined; c) All literatures did not indicate whether the subjects, interventions and outcomes in the noninferiority and equivalence trials were identical or similar to those in previous trials of defining the effectiveness of control treatment; d) Most literatures did not define the critical value of noninferiority and equivalence, and did not estimate the sample size; e) Only half of literature described the statistical methods of noninferiority test and equivalence test; and f) Some literature had mistakes in noninferiority and equivalence conclusion. Conclusion The researchers still need deeper understanding of the theoretical basis of noninferiority and equivalence trials. The reference to the extended version of CONSORT statement, which refers to the reporting standard of noninferiority and equivalence RCTs, is helpful for researchers to identify the key points of the design, performance and reporting of the noninferiority and equivalence RCTs, to lay stress on the related contents of noninferiority and equivalence trial reporting, and to radically improve the reporting quality of such clinical trials.
To improve the comprehensive and accurate of overviews of reviews, BMJ published the guideline for overviews of reviews of healthcare interventions: the PRIOR statement. This paper explained the background and core contents of PRIOR statement and interpreted each item with examples to provide references for domestic scholars to write overviews of reviews.