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

Cochrane vs Non-Cochrane Review in IBD: A Systematic Review

In meta-analyses with the same set of interventions and outcomes, what are the differences in terms of methodological and statistical quality, and effect size

The Quality of reporting Inflammatory Bowel Disease Randomized Control Trials: A systematic review

Objective Our objective was to perform a systemic evaluation of the risk of bias in randomized control trials’ (RCTs) reports published on IBD. Design We assessed the risk of bias using the Cochrane tool, as indicators of poor methodology or subsequently poor reporting. We systematically selected, with dual independent judgements, all studies published on IBD with no time limits and assessed the methodological quality of included studies again using independent dual ratings. Results 563 full texts were included after selection and review. No abstract publications were free of any source of bias. Full-text publications still fared badly, as only 103 full-text papers exhibited a low risk of bias in all reporting domains when excluding blinding. RCTs published in journals with higher IF were associated with an overall reduced rate of being at high risk. However, only 6% of full RCT publications in journals with an impact factor greater than 10, published in the past 5 years, were free of bias. The trend over time is towards improved reporting in all areas. Trials published by larger author teams, in full-text form and by industry and public sponsorship were positively correlated with a lower risk of bias. Only allocation concealment showed a statistically significant improvement with time (p=0.037). Conclusion These findings are consistent with those of other specialities in the literature. Whilst this unclear risk of bias may represent poor reporting of methods instead of poor methodological quality, it leaves readers and future secondary researchers with significant questions regarding such key issues

Patient education interventions for the management of Inflammatory Bowel Disease

Objectives This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To identify the different types of educational interventions, how they are delivered, and to determine their effectiveness and safety in people with IBD

P056 Power Calculations in Randomised Controlled Trials of Inflammatory Bowel Disease

Background: Sample size estimation is a vitally important calculation to make when designing a clinical trial. 25% of randomised controlled trials (RCTs) on interventions for Inflammatory Bowel Disease (IBD) have no power calculation (PC). We set out to systematically review RCTs reporting interventions for the management of IBD and to use the actual clinical data across these comparisons to produce data for minimum sample sizes that would achieve appropriate power. Methods: We included RCTs investigating any form of therapy for the treatment of IBD in patients of any age and interventions for either induction or maintenance of remission against control, placebo, or no intervention. The relevant data was extracted, and the studies were grouped according to the intervention used. We recalculated sample size and the achieved difference, as well as minimum sample sizes needed in the future. Results: A total of 105 trials were included. There was a large discrepancy between the estimated figure for the minimal clinically important difference used for power calculations and the actual differences seen. The minimum sample sizes to use in future trials were proposed based on the calculations made from actual achieved clinical differences from previous studies. Conclusion: A third of intervention studies in IBD within the last 25 years are underpowered, with large variations in the calculation of sample sizes. The resource containing sample size estimates constructed on the published evidence base is required for future researchers and key stakeholders within the IBD trial field

Minimum sample size estimates for trials in inflammatory bowel disease: A systematic review of a support resource

Of 25% of randomised controlled trials (RCTs) on interventions for inflammatory bowel disease (IBD) have no power calculation. To systematically review RCTs reporting interventions for the management of IBD and to produce data for minimum sample sizes that would achieve appropriate power using the actual clinical data. We included RCTs retrieved from Cochrane IBD specialised Trial register and CENTRAL investigating any form of therapy for either induction or maintenance of remission against control, placebo, or no intervention of IBD in patients of any age. The relevant data was extracted, and the studies were grouped according to the intervention used. We recalculated sample size and the achieved difference, as well as minimum sample sizes needed in the future. A total of 105 trials were included. There was a large discrepancy between the estimated figure for the minimal clinically important difference used for the calculations (15% group differences observed 30% used for calculation) explaining substantial actual sample size deficits. The minimum sample sizes indicated for future trials based on the 25 years of trial data were calculated and grouped by the intervention. A third of intervention studies in IBD within the last 25 years are underpowered, with large variations in the calculation of sample sizes. The authors present a sample size estimate resource constructed on the published evidence base for future researchers and key stakeholders within the IBD trial field. [Abstract copyright: ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.

Remote care through telehealth for people with inflammatory bowel disease

Objectives This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To identify the communication technologies used for remote healthcare sessions, how they are used, their accessibility, and their potential benefits and drawbacks for people with inflammatory bowel disease

480 The Quality of Reporting Inflammatory Bowel Disease Randomized Control Trials: A Systematic Review

Aim Our objective was to perform a systemic evaluation of the risk of bias of randomized control trials’ (RCTs) reports published on IBD. Method We assessed the risk-of-bias using the Cochrane tool, as indicators for poor methodology or subsequently poor reporting. We focused on assessing the risk-of -bias pertaining to appropriate sequence generation, allocation concealment, blinding, incomplete outcome data reporting and other bias. We systematically selected, with dual independent judgements, all studies published on IBD with no time limits and assessed the methodological quality of included studies again using independent dual ratings, with disagreement solved through a third author. Results 563 full texts were included after selection and review. When excluding blinding, 103 papers exhibited low risk of bias in all reporting domains, none of which were publications. RCTs published in journals with higher IF were associated with an overall reduced rate of being at high risks. However, only 6% of full RCT publications in journals with IF greater than 10, published in the past 5 years, were free of bias. The trend over time is towards improved reporting in all areas. Trials published by larger author teams, in full-text form and by industry and public sponsorship were positively correlated with lower risk of bias. Only allocation concealment showed a statistically significant improvement with time (p = 0.037). Conclusions These findings are consistent with those of other specialties in the literature. Whilst this may represent poor reporting instead of poor quality, it leaves readers and future secondary researchers with significant questions regarding such key issues

(Review) Remote care through telehealth for people with inflammatory bowel disease

Background After diagnosis, intensive follow-up is required to optimise IBD care, usually necessitating the need for frequent consultations. IBD telehealth management includes consulting by phone, instant messenger, video, text message, or webbased services. Telehealth can be beneficial for people with IBD; however, it can have its own set of challenges. It is important to systematically review the evidence on the types of remote or telehealth approaches that can be deployed in IBD, particularly given the COVID-19 pandemic, which has necessitated increases in self-and remote-management. Objectives To identify the communication technologies used to achieve remote healthcare for people with inflammatory bowel disease and to assess their effectiveness. Search methods On 13 January 2022, we searched 8 databases (e.g. CENTRAL, Embase, MEDLINE, ClinicalTrials.gov, WHO ICTRP with no limitations to language, date, document type, or publication status. Selection criteria All published, unpublished and ongoing RCTs that compare telehealth interventions targeted at people with IBD to any other type of intervention or no intervention. We did not include studies on digital patient information resources, or education resources alone, unless they formed part of a wider package that includes an element of telehealth. We excluded studies where remote monitoring of blood or faecal tests was included as the only form of monitoring. Data collection and analysis Two review authors independently conducted data extraction and 'Risk of bias' assessment of the included studies. We analysed data using Review Manager Web. We analysed studies on adult and paediatric populations separately. We expressed dichotomous and continuous outcomes as risk ratios and mean differences with 95% confidence intervals. We assessed the certainty of the evidence using GRADE methodology. Main results We included 19 RCTs with a total of 3489 randomised participants, aged 8-95 years old. Three studies examined exclusively UC populations, two studies examined exclusively CD, and the remaining studies examined a mix of IBD Manuscript Click here to access/download;Manuscript;Pdf_CD014821_4- 5.pdf patients. Studies considered a range of disease activity states. The length of the interventions ranged from 6 months to 2 years. The telehealth interventions were web-based and telephone-based. Twelve studies compared web-based disease monitoring to usual care. Three studies, all on adults, provided data on disease activity. Web-based disease monitoring (n=254) is probably equivalent to usual care (n=174) in reducing disease activity in patients with IBD (SMD 0.09, 95% CI -0.11 to 0.29). The certainty of the evidence is moderate. Five studies on adults provided dichotomous data that we could use for a meta-analysis on flare-ups. Web-based disease monitoring (n=207/496) is probably equivalent to usual care (n=150/372) for the occurrence of flare-ups or relapses in patients with IBD (RR 1.09, 95% CI 0.93 to 1.27). The certainty of the evidence is moderate. One study provided continuous data. Web-based disease monitoring (n=465) is probably equivalent to usual care (n=444) for the occurrence of flare-ups or relapses in CD patients (MD 0.00, 95% CI -0.06 to 0.06). The certainty of the evidence is moderate. One study provided data on a paediatric population. Web-based disease monitoring (n=28/84) may be equivalent to usual care (n=29/86) for the occurrence of flare-ups or relapses in paediatric patients with IBD (RR 0.99, 95% CI 0.65 to 1.51). The certainty of the evidence is low. Four studies, all on adults, provided data on quality of life. Web-based disease monitoring (n=594) is probably equivalent to usual care (n=505) for quality of life in patients with IBD (SMD 0.08, 95% CI -0.04 to 0.20). The certainty of the evidence is moderate. Using continuous data from one study on adults, web-based disease monitoring probably leads to slightly higher medication adherence compared to usual care (MD 0.24, 95% CI 0.01 to 0.47). The results are of moderate certainty. Using continuous data from one paediatric study, it is unclear whether web-based disease monitoring is equivalent to usual care for medication adherence in children (MD 0.00, 95% CI -0.63 to 0.63). The results are of very low certainty. Using dichotomous data from two studies on adults, it is unclear whether web-based disease monitoring is equivalent to usual care for medication adherence (RR 0.87, 95% CI 0.62 to 1.21). The results are of very low certainty. No conclusions can be made on the effects of web-based disease monitoring compared to usual care on healthcare access, patient engagement, attendance rate, interactions with healthcare professionals, and cost or time effectiveness. The certainty of the evidence is very low