Assessment of consistency between peer-reviewed publications and clinical trial registrations in nursing journals.

BACKGROUND: 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. AIMS: 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. METHODS: 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. RESULTS: 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. LINKING EVIDENCE TO ACTION: 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.

Correlates of Physical Activity in Colorectal Cancer Patients Based on Health Promotion Model.

BACKGROUND: Increasing attention is being given to physical activity in colorectal cancer patients. Some studies have explored a few correlates of physical activity separately. A contemporary study based on the Health Promotion Model may systematically broaden the understanding of physical activity in colorectal cancer patients. OBJECTIVE: To understand the status of physical activity in Chinese colorectal cancer patients and to explore the correlated factors. METHODS: A total of 168 adults with colorectal cancer were recruited at 3 tertiary hospitals in China. Participant data were collected on demographics, physical activity, biological factors, anxiety and depression, benefits/barriers to physical activity, self-efficacy, and social support. SAS 8.2 was used for statistical analysis, including descriptive analysis, correlation analysis, single factor analysis, and multiple stepwise regression analysis. RESULTS: Only 25.60% of colorectal cancer survivors reached the requirements of the Colorectal Cancer Survivorship Care Guidelines. Employment states, number of complications, fatigue, body image, depression, perception of benefits/barriers, and self-efficacy were closely correlated with physical activity in Chinese colorectal cancer patients. CONCLUSIONS: The physical activity status of patients with colorectal cancer is not optimal. The correlated factors that nurses can take measures to improve are fatigue, body image, depression, perception of benefits/barriers, and self-efficacy, which may improve physical activity in colorectal cancer patients in China. Additional research is needed to determine if improving factors correlated with physical activity will assist with directly increasing physical activity. IMPLICATIONS FOR PRACTICE: Nurses should evaluate physical activity of colorectal cancer patients timely and play an active role in health promotion programs to improve colorectal cancer patients' physical activity.

Empirical evidence for outcome reporting bias in randomized clinical trials of acupuncture: comparison of registered records and subsequent publications.

BACKGROUND: Outcome reporting bias has received widespread recognition and been considered to pose two threats to the validity of clinical decision making because they overestimate the effect of treatments or distort the results of trials. However, the problem of outcome-reporting bias has not been systematically studied among randomized clinical trials of acupuncture. Our objectives were to evaluate the consistency between the registered records and subsequent publications with respect to outcomes and other data as well as to determine whether outcome-reporting bias favors significant primary outcomes. METHODS: A systematic search of 15 registries was conducted from their inception to January 2014 to identify randomized clinical trials on acupuncture for which the status was listed as 'completed.' The subsequent publications were retrieved by searching PubMed and three Chinese databases. Basic characteristics and the registration information were extracted from the registered records and publications. We performed comparisons regarding primary outcomes and other data between the registered records and subsequent publications to assess the consistency and selective outcome reporting. RESULTS: Eighty-eight trials on acupuncture with 96 published reports were identified. Only 19.3% (17/88) were registered before the start of the trial, suggesting prospective registration. The trial registration number was unavailable in 36 published reports (37.5%). A comparison of registered and published primary outcomes could be conducted in 71 publications (74.0%), and the inconsistency of the primary outcomes was identified in 45.1% (32 of 71); 71.4% (15 of 21) had a discrepancy that favored statistically significant primary outcomes, while 28.6% (6 of 21) favored nonsignificant primary outcomes. Furthermore, the other inconsistencies between the registry records and subsequent publications involved the inclusion criteria (54.7%), exclusion criteria (47.9%) and controls (22.9%). CONCLUSIONS: We find that prospective registration for randomized clinical trials on acupuncture is insufficient, selective outcome reporting is prevalent, and the change of primary outcomes is intended to favor statistical significance. These discrepancies in outcome reporting may lead to biased and misleading results of randomized clinical trials on acupuncture. To ensure publication of reliable and unbiased results, further promotion and implementation of trial registration are still needed.

Chinese herbal medicine for cancer-related fatigue: a systematic review of randomized clinical trials.

OBJECTIVES: To assess the effectiveness and safety of Chinese herbal medicine for the treatment of cancer-related fatigue. METHODS: We systematically searched seven electronic databases and two trial registries for randomized clinical trials of Chinese herbal medicine for cancer-related fatigue. Two authors independently extracted data and assessed the methodological quality of the included trials using the Cochrane risk of bias tool. Data were synthesized using RevMan 5.2 software. RESULTS: A total of 10 trials involving 751 participants with cancer-related fatigue were identified and the methodological quality of the included trials was generally poor. Chinese herbal medicine used alone or in combination with chemotherapy or supportive care showed significant relief in cancer-related fatigue compared to placebo, chemotherapy or supportive care based on single trials. Chinese herbal medicine plus chemotherapy or supportive care was superior to chemotherapy or supportive care in improving quality of life. Data from one trial demonstrated Chinese herbal medicine exerted a greater beneficial effect on relieving anxiety but no difference in alleviating depression. Seven trials reported adverse events and no severe adverse effects were found in Chinese herbal medicine groups. CONCLUSIONS: The findings from limited number of trials suggest that Chinese herbal medicine seems to be effective and safe in the treatment of cancer-related fatigue. However, the current evidence is insufficient to draw a confirmative conclusion due to the poor methodological quality of included trials. Thus, conducting rigorously designed trials on potential Chinese herbal medicine is warranted.