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The inconsistencies between randomized clinical trials (RCTs) registrations and peer-reviewed publications may distort trial results and threaten the validity of evidence-based medicine. Previous studies have found many inconsistencies between RCTs registrations and peer-reviewed publications, and outcome reporting bias is prevalent.
The aims of this review were to assess whether the primary outcomes and other data reported in publications and registered records in RCTs of nursing journals were consistent and whether discrepancies in the reporting of primary outcomes favored statistically significant results. Moreover, we reviewed the proportion of RCTs for prospective registration.
We systematically searched PubMed for RCTs published in the top 10 nursing journals between March 5, 2020, and March 5, 2022. Registration numbers were extracted from the publications, and registered records were identified from the registration platforms. The publications and registered records were compared to identify consistency. Inconsistencies were subdivided into discrepancies and omissions.
A total of 70 RCTs published in seven journals were included. The inconsistencies involved sample size estimation (71.4%), random sequence generation (75.7%), allocation concealment (97.1%), blinding (82.9%), primary outcomes (60.0%) and secondary outcomes (84.3%). Among the inconsistencies in the primary outcomes, 21.4% were due to discrepancies and 38.6% resulted from omissions. Fifty-three percent (8/15) presented discrepancies in the primary outcomes that favored statistically significant results. Additionally, although only 40.0% of the studies were prospective registrations, the number of prospectively registered trials has trended upward over time.
While not including all RCTs in the nursing field, our sample reflected a general trend: inconsistencies between publications and trial registrations were prevalent in the included nursing journals. Our research helps to provide a way to improve the transparency of research reports. Ensuring that clinical practice has access to transparent and reliable research results are essential to achieve the best possible evidence-based medicine.
Primary dysmenorrhea (PD) is a global public health concern affecting women's health and quality of life, leading to productivity loss and increased medical expenses. As a non-pharmacological intervention, auricular acupoint therapy (AAT) has been increasingly applied to treat PD, but the overall effectiveness remains unclear.
The aim of this review was to synthesize the effects of AAT targeting menstrual pain among females with PD.
Eight databases (PubMed, EMBASE, AMED, CINAHL Plus, Cochrane Library, Web of Science, China National Knowledge Infrastructure and Wanfang Data) and three registries (ClinicalTrials.gov, ISRCTN Registry and the Chinese Clinical Trial Registry) were searched to identify existing randomized controlled trials (RCTs) from inception to 21 August 2022. Two reviewers independently screened, extracted the data, and appraised the methodological quality and the evidence strength using the Cochrane risk-of-bias tool for randomized trials (RoB 2) and the GRADE approach.
A total of 793 participants from 11 RCTs were included. Despite substantial heterogeneity, AAT was more effective in reducing menstrual pain and related symptoms than placebo and nonsteroidal anti-inflammatory medications (NSAIDs). No significant subgroup differences were found between study locations as well as invasiveness, duration, type, acupoints number, ear selection and provider of AAT. Only minor adverse effects of AAT were reported.
AAT can help women with PD, particularly those who are refrained from pharmaceuticals. Primary healthcare professionals, including nurses, can be well-equipped to provide evidence-based and effective AAT for people with PD. AAT can be used in a broader global clinical community. To provide an optimal effect and have wider usability, a unified practice standard is required, which would necessitate further adaptation of clinical care of people with PD. AAT effectively decreased menstrual pain and other accompanying symptoms of PD. More research is needed to identify effective AAT features and explore optimal therapy regimes for PD.
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