Sample-size estimation is not reported in 24% of randomised controlled trials of inflammatory bowel disease: A systematic review

Background Sample-size estimation is an important factor in designing a clinical trial. A recent study found that 65% of Cochrane systematic reviews had imprecise results. Objective This study set out to review the whole body of inflammatory bowel disease (IBD) randomised controlled trials systematically in order to identify the reporting of sample-size estimation. Methods We conducted a comprehensive hand search of the Cochrane Library and Cochrane IBD Specialized Trials Register. We extracted information on relevant features and the results of the included studies. We produced descriptive statistics for our results. Results A total of 242 randomised controlled trials were included from 44 Cochrane systematic reviews. About 25% of the studies failed to report on sample-size estimation. Of those that did report on sample-size estimation, 33% failed to recruit their target sample size. Conclusions Around half of the randomised controlled trials in IBD either do not report sample-size estimation or reach their recruitment target with the level of detail in reporting being limited

Probiotics for maintenance of remission in ulcerative colitis

Ulcerative colitis is an inflammatory condition affecting the colon, with an annual incidence of approximately 10 to 20 per 100,000 people. The majority of people with ulcerative colitis can be put into remission, leaving a group who do not respond to first‐ or second‐line therapies. There is a significant proportion of people who experience adverse effects with current therapies. Consequently, new alternatives for the treatment of ulcerative colitis are constantly being sought. Probiotics are live microbial feed supplements that may beneficially affect the host by improving intestinal microbial balance, enhancing gut barrier function and improving local immune response

Dietary interventions for functional abdominal pain disorders in children: a systematic review and meta-analysis

Background Functional abdominal pain disorders (FAPDs) are common among children and are associated with decreased quality of life and school attendance. Several dietary interventions have been suggested to improve symptoms of FAPDs. This systematic review assessed the efficacy and safety of dietary interventions for pediatric FAPDs. Design and methods Electronic databases were searched (inception–October 2021). Systematic reviews or RCTs were included if children (4–18 years) with FAPDs were treated with dietary interventions and compared to placebo, no diet or any other diet. Data extraction and assessment of quality of evidence based on GRADE system was independently performed by two review authors. Outcomes were treatment success, pain intensity and frequency, and withdrawal due to adverse events. Results Twelve articles were included, representing data of 819 pediatric FAPD patients. Trials investigating fibers, FODMAP diet, fructans, fructose-restricted diet, prebiotic (inulin), serum-derived bovine immunoglobulin, and vitamin D supplementation were included. We found very low-certainty evidence that the use of fibers leads to higher treatment success (NNT = 5). Conclusion Based on current evidence, the use of fibers can be discussed in daily practice. High-quality intervention trials are highly needed to investigate if other dietary interventions are effective in the treatment of pediatric FAPD

Interventions for treating iron deficiency anaemia in inflammatory bowel disease: a network meta-analysis

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: The primary objective will be to evaluate the efficacy and harms of the interventions for the treatment of iron deficiency anaemia in people with inflammatory bowel disease and rank the treatments in order of effectiveness in a network meta‐analysis

Pre-publication abstract-only reports compared to full-text manuscripts for randomised controlled trials in inflammatory bowel disease: a systematic review

Introduction: RCTs of key therapies in IBD are often presented and available as abstracts for significant periods of time prior to full publication, often being employed to make strategic and clinical prescribing decisions. We compared the concordance of pre-publication abstract-only reports and their respective full-text manuscripts. Methods: Pairs of full-text manuscripts and their respective pre-publication abstract-only reports for the same RCT outcomes, at the same timepoint of analysis were included. The RCTs were on treatments for IBD with full-text manuscripts published between 2010-2023. Results: We found 77 pairs of full-text manuscripts and their pre-publication abstract-only reports. There were significant mis-matches in the reporting of; stated planned outcomes (65/77 matched, p<0.001), and primary outcomes reported in their results sections (67/77, p<0.001); trial registrations (34/65, p<0.001); numbers of randomised participants (49/77, p=0.18); participants reaching end of study (21/71, p<0.001); and primary outcome data (40/73, p<0.001). Authors conclusions matched (75/77, p=0.157). Authors did not provide explicit or implied justifications for the absence or non-concordance for any of the above items. Conclusions: Abstract-only reports have consistent issues with both limited reporting of key information and significant differences in data when compared with their later full-text publications. These are not related to further recruitment of patients or word count limitations, and are never explained. As abstracts are often used in guidelines, reviews and stakeholder decision making on prescribing, caution in their use is strongly suggested. Further work is needed to enhance minimum reporting standards in abstract-only works and ensure consistency with final published papers. What is already known on this topic – Data from abstract-only reports of RCTs are often used as evidence sources for clinical and strategic decision-making in IBD. It is not known whether they are up to par for this purpose. What this study adds – Our findings suggest that abstract-only reports are often inconsistent in their reporting, compared with their respective full-text manuscripts, especially in areas such as flow of participants and primary outcome data. These are not related to further recruitment of patients or word count limitations, and are never explained. How this study might affect research, practice or policy – Caution is advised when abstract-only reports are used as evidence sources. Enhanced minimum reporting standards for abstract-only reports need to be employe