Quality of reporting inflammatory bowel disease randomised controlled trials: a systematic review.

OBJECTIVE: Our objective was to perform a systemic evaluation of the risk of bias in randomised controlled trial (RCT) reports published on inflammatory bowel disease (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 impact factor (IF) were associated with an overall reduced rate of being at high risk. However, only 6% of full RCT publications in journals with an 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 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 specialties in the literature. While 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.

Oncological outcomes of patients with oligometastatic oesophagogastric cancer.

Oligometastatic oesophagogastric cancer was recently defined by consensus as the presence of no more than two metastases and an 18-week period of oncological stability during chemotherapy. The number of patients who fit this criterion and whether their oncological outcome differs from those with multi-metastatic disease is unknown. We analysed a database of 497 patients from 2017 to 2021 with metastatic oesophageal cancer. In total, 36 (7.2%) had oligometastatic disease and significantly improved median overall survival (mOS) versus multi-metastatic disease. In synchronous OMD, mOS was 26.8 months versus 7.3 months and in metachronous OMD, 38.6 months versus 6.1 months (both p < 0.0001). A subset of oligometastatic patients who underwent surgical management of their oligometastases after primary tumour resection demonstrated significantly increased mOS compared with systemic treatment alone (60 months versus 24.4 months; p < 0.038). Oligometastatic oesophagogastric cancer is associated with improved oncological outcome when compared to multi-metastatic disease. Further work is needed to identify patients who will benefit from aggressive treatment of metastatic oesophagogastric cancer.

Remote care through telehealth for people with inflammatory bowel disease.

BACKGROUND: People with inflammatory bowel disease (IBD) require intensive follow-up with frequent consultations after diagnosis. IBD telehealth management includes consulting by phone, instant messenger, video, text message, or web-based services. Telehealth can be beneficial for people with IBD, but may 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. This is particularly relevant following the coronavirus disease 2019 (COVID-19) pandemic, which led to increased 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 CENTRAL, Embase, MEDLINE, three other databases, and three trials registries with no limitations on language, date, document type, or publication status. SELECTION CRITERIA: All published, unpublished, and ongoing randomised controlled trials (RCTs) that evaluated telehealth interventions targeted at people with IBD versus any other type of intervention or no intervention. We did not include studies based on digital patient information resources or education resources, unless they formed part of a wider package including an element of telehealth. We excluded studies where remote monitoring of blood or faecal tests was the only form of monitoring. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data from the included studies and assessed their risk of bias. We analysed studies on adult and paediatric populations separately. We expressed the effects of dichotomous outcomes as risk ratios (RRs) and the effects of continuous outcomes as mean differences (MDs) or standardised mean differences (SMDs), each with their 95% confidence intervals (CIs). We assessed the certainty of the evidence using GRADE methodology. MAIN RESULTS: We included 19 RCTs with a total of 3489 randomised participants, aged eight to 95 years. Three studies examined only people with ulcerative colitis (UC), two studies examined only people with Crohn's disease (CD), and the remaining studies examined a mix of IBD patients. Studies considered a range of disease activity states. The length of the interventions ranged from six months to two years. The telehealth interventions were web-based and telephone-based. Web-based monitoring versus usual care Twelve studies compared web-based disease monitoring to usual care. Three studies, all in 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 people 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 adults 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 adults with CD (MD 0.00 events, 95% CI -0.06 to 0.06). The certainty of the evidence is moderate. One study provided dichotomous data on flare-ups in 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 children with IBD (RR 0.99, 95% CI 0.65 to 1.51). The certainty of the evidence is low. Four studies, all in 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 adults with IBD (SMD 0.08, 95% CI -0.04 to 0.20). The certainty of the evidence is moderate. Based on continuous data from one study in adults, we found that web-based disease monitoring probably leads to slightly higher medication adherence compared to usual care (MD 0.24 points, 95% CI 0.01 to 0.47). The results are of moderate certainty. Based on continuous data from one paediatric study, we found no difference between web-based disease monitoring and usual care in terms of their effect on medication adherence (MD 0.00, 95% CI -0.63 to 0.63), although the evidence is very uncertain. When we meta-analysed dichotomous data from two studies on adults, we found no difference between web-based disease monitoring and usual care in terms of their effect on medication adherence (RR 0.87, 95% CI 0.62 to 1.21), although the evidence is very uncertain. We were unable to draw any conclusions on the effects of web-based disease monitoring compared to usual care on healthcare access, participant engagement, attendance rate, interactions with healthcare professionals, and cost- or time-effectiveness. The certainty of the evidence is very low. AUTHORS' CONCLUSIONS: The evidence in this review suggests that web-based disease monitoring is probably no different to standard care in adults when considering disease activity, occurrence of flare-ups or relapse, and quality of life. There may be no difference in these outcomes in children, but the evidence is limited. Web-based monitoring probably increases medication adherence slightly compared to usual care. We are uncertain about the effects of web-based monitoring versus usual care on our other secondary outcomes, and about the effects of the other telehealth interventions included in our review, because the evidence is limited. Further studies comparing web-based disease monitoring to standard care for the clinical outcomes reported in adults are unlikely to change our conclusions, unless they have longer follow-up or investigate under-reported outcomes or populations. Studies with a clearer definition of web-based monitoring would enhance applicability, enable practical dissemination and replication, and enable alignment with areas identified as important by stakeholders and people affected by IBD.

Is it possible to predict the severity of acute appendicitis? Reliability of predictive models based on easily available blood variables.

INTRODUCTION: Recent evidence confirms that the treatment of acute appendicitis is not necessarily surgical, and selected patients with uncomplicated appendicitis can benefit from a non-operative management. Unfortunately, no cost-effective test has been proven to be able to effectively predict the degree of appendicular inflammation as yet, therefore, patient selection is too often left to the personal choice of the emergency surgeon. Our paper aims to clarify if basic and readily available blood tests can give reliable prognostic information to build up predictive models to help the decision-making process. METHODS: Clinical notes of 2275 patients who underwent an appendicectomy with a presumptive diagnosis of acute appendicitis were reviewed, taking into consideration basic preoperative blood tests and histology reports on the surgical specimens. Variables were compared with univariate and multivariate analysis, and predictive models were created. RESULTS: 18.2% of patients had a negative appendicectomy, 9.6% had mucosal only inflammation, 53% had transmural inflammation and 19.2% had gangrenous appendicitis. A strong correlation was found between degree of inflammation and lymphocytes count and CRP/Albumin ratio, both at univariate and multivariate analysis. A predictive model to identify cases of gangrenous appendicitis was developed. CONCLUSION: Low lymphocyte count and high CRP/Albumin ratio combined into a predictive model may have a role in the selection of patients who deserve appendicectomy instead of non-operative management of acute appendicitis.

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

BACKGROUND: Of 25% of randomised controlled trials (RCTs) on interventions for inflammatory bowel disease (IBD) have no power calculation. AIM: 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. METHODS: 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. 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 the calculations (15% group differences observed vs 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. 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 authors present a sample size estimate resource constructed on the published evidence base for future researchers and key stakeholders within the IBD trial field.

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.