Clinical trial transparency in gastrointestinal endoscopy research.

BACKGROUND: Under-reporting of clinical trial results can lead to negative consequences that include inhibiting propagation of knowledge, limiting the understanding of how devices work, affecting conclusions of meta-analyses, and failing to acknowledge patient participation. Therefore clinical trial transparency, through publication of trial results on ClinicalTrials.gov or in manuscript form, is important. We aimed to examine clinical trial transparency in endoscopic clinical trials. METHODS: The ClinicalTrials.gov database was searched for endoscopy trials up to October 2019. Adherence to the reporting of results to the database or in publication form was recorded for each trial. RESULTS: The final analysis included 923 trials, of which 801 were completed and 122 were either terminated or suspended. Results were available either on ClinicalTrials.gov or in publication for 751/923 trials (81.4 %). Other fields have reported a publication rate of 40 %-63 %. Results were available on ClinicalTrials.gov for 168 trials (18.2 %) and in the form of a publication for 720 trails (78.0 %). CONCLUSIONS: Compared with other fields in medicine, endoscopy clinical trials have a high rate of clinical trial transparency. However, there is room for improvements as close to one-fifth of trials fail to report results and 81.8 % do not report results to ClinicalTrials.gov.

Auditing Management of Acute Pancreatitis Using Comprehensive Quality Indicators.

OBJECTIVES: Recently, 40 comprehensive quality indicators in various management domains were created. The aim was to determine if these indicators could be used to audit the management of acute pancreatitis. METHODS: A retrospective study of consecutive patients admitted with acute pancreatitis in 2018 was conducted. Adherence rates with the individual quality indicators were calculated and compared between services. RESULTS: A total of 320 patients were included in this study. Twenty-eight of the 40 quality indicators (70%) could be used to audit management retrospectively. The medical service was found to have lower adherence rates for quality indicators 12 (initial assessment and risk stratification domain; 11% vs 22%, P = 0.009), 14 (initial management domain; 72% vs 88%, P = 0.003), and 33 (surgery domain; 83% vs 100%, P = 0.006). The surgical service was noted to have statistically significant lower adherence rates for quality indicators 4, 5, and 6 of the etiology domain (54% vs 72%, P = 0.002; 86% vs 96%, P = 0.004; and 45% vs 71%, P < 0.0001, respectively), and 21 of the nutrition domain (76% vs 93%, P < 0.0001). CONCLUSIONS: We show that these quality indicators can be used to audit the management of acute pancreatitis in specific management domains.

Gastroenterology Clinical Trials Transparency: An Analysis of Publication Rates From the ClinicalTrials.gov Database.

INTRODUCTION: There is limited information on the transparency of gastroenterology clinical trials. METHODS: The ClinicalTrials.gov database was searched for trials focused on most common gastrointestinal diseases up to August 2018. Adherence to reporting of results to the database or in publication form was recorded for each trial along with trial characteristics. RESULTS: Of the 2,429 trials included in the final analysis, 1824 (75%, 95% confidence interval: 73.4%-76.8%) had results on ClinicalTrials.gov or in the form of a publication. However, only 534 (29%) had results posted on ClinicalTrials.gov. DISCUSSION: Improvement of clinical trial transparency is needed in gastroenterology.

Analysis of Outcomes in COVID-19 Patients With Varying Degrees of Hyperlipasemia.

OBJECTIVES: Coronavirus disease 2019 (COVID-19) patients may have varying degrees of hyperlipasemia. The aim was to compare outcomes among different levels of hyperlipasemia in patients with COVID-19. METHODS: This is a retrospective study examining outcomes among hospitalized COVID-19 patients with a lipase <3× upper limit of normal (ULN), asymptomatic hyperlipasemia (>3× ULN), secondary pancreatitis (typical respiratory COVID-19 symptoms and found to have pancreatitis), and primary pancreatitis (presenting with pancreatitis). RESULTS: Of 11,883 patients admitted with COVID-19, 1560 patients were included: 1155 patients had normal serum lipase (control group), 270 had elevated lipase <3× ULN, 46 patients had asymptomatic hyperlipasemia with lipase >3× ULN, 57 patients had secondary pancreatitis, and 32 patients had primary pancreatitis. On adjusted multivariate analysis, the elevated lipase <3× ULN and asymptomatic hyperlipasemia groups had worse outcomes with higher mortality (odds ratio [OR], 1.6 [95% confidence interval [CI], 1.2-2.2) and 1.1 [95% CI, 0.5-2.3], respectively), higher need for mechanical ventilation (OR, 2.8 [95% CI, 1.2-2.1] and 2.8 [95% CI, 1.5-5.2], respectively), and longer length of stay (OR, 1.5 [95% CI, 1.1-2.0] and 3.16 [95% CI, 1.5-6.5], respectively). CONCLUSIONS: Patients with COVID-19 with elevated lipase <3× ULN and asymptomatic hyperlipasemia have generally worse outcomes than those with pancreatitis.

Acute pancreatitis in children hospitalized with COVID-19.

BACKGROUND: Limited data exists on the association or prevalence of pancreatitis in children with COVID-19. METHODS: This is a retrospective study of pediatric patients admitted to a large health system in New York (Northwell Health System) from March 1, 2020-June 1, 2020 during the COVID-19 pandemic. RESULTS: 8159 pediatric patients were admitted to our healthcare system during the study period, of which 112 were diagnosed with COVID-19 (1.37%). Thirteen were diagnosed with pancreatitis for a point prevalence of 0.16% (13/8159) for all patients admitted. Of the thirteen patients admitted with pancreatitis, two patients were COVID-19 positive for a point prevalence of 1.8% (2/112) among COVID-19 patients compared to 0.14% (11/8047) in the non-COVID-19 population. CONCLUSIONS: This study shows that pancreatitis can occur in pediatric patients with COVID-19 and may be more common in the COVID-19 population.

EUS assessment for intermediate risk of choledocholithiasis after a negative magnetic resonance cholangiopancreatography.

BACKGROUND AND AIMS: Guidelines recommend either EUS or magnetic resonance cholangiopancreatography (MRCP) for intermediate risk of choledocholithiasis. There is a lack of evidence that supports proceeding with EUS if the MRCP is negative and if clinical suspicion still exists. METHODS: This is a retrospective study of all patients who underwent EUS to assess for choledocholithiasis at a tertiary care referral center from July 2013 to October 2019. RESULTS: A total of 593 patients underwent EUS for evaluation for choledocholithiasis. Of the 593 patients, 35.2% (209/593) had an MRCP. 73.2% (153/209) had a negative MRCP while 26.8% (56/209) had a positive MRCP. Of the group of patients who underwent EUS with a negative MRCP, 15% (23/153) were positive for choledocholithiasis on EUS. Of these, 91% (21/23) were also positive for sludge or stones on endoscopic retrograde cholangiopancreatography and thus 14% (21/153) of the EUS were "true positives." There were no clinical or laboratory factors predictive of choledocholithiasis on univariate analysis in the EUS plus negative MRCP group. When further analyzing the MRCP negative group into MRCP-/EUS+ and MRCP-/EUS-subgroups, a total bilirubin >3 mg/dL predicted a bile duct stone (55% vs. 32%, P = 0.05). CONCLUSION: The diagnostic yield of EUS for suspected choledocholithiasis in the setting of a negative MRCP is 14% in our cohort. EUS should be considered in patients with intermediate risk of choledocholithiasis with a negative MRCP if the clinical suspicion is still present, and especially if the total bilirubin is above 3 mg/dL.

Sorrow, coping and resiliency: parents of children with cerebral palsy share their experiences.

PURPOSE: To explore the grieving, coping and resiliency experiences of parents of children with cerebral palsy (CP) and to investigate the suitability of chronic sorrow theory as a framework to understand those experiences. METHODS: This study combined focus groups with a web-based cross-sectional survey to explore chronic sorrow in parents of children with CP. Eight parents of children with CP participated in focus groups. The discussion was transcribed verbatim and thematic analysis was performed. A further 94 parents participated in the web-based survey study in which they completed the Adapted Burke Questionnaire on chronic sorrow. A content analysis of responses was used to confirm the primary qualitative analysis. RESULTS: The reports of parents in the focus group were consistent with chronic sorrow theory, as were the responses of parents to the web-based survey. Some parents found the diagnosis itself a distressing time whereas others found it a relief. Parents reported that times of medical and allied health intervention were particularly challenging. CONCLUSION: Chronic sorry theory is a useful way of understanding the experiences of parents of children with CP. It is recommended that health practitioners are mindful that, even years after diagnosis, parents of children with CP may experience intensified chronic sorrow symptoms following a triggering event and that this is normal.

Responding to the challenges of parenting a child with cerebral palsy: a focus group.

PURPOSE: To explore the unique parenting challenges that parents of children with cerebral palsy (CP) face and to explore the feasibility of a new parenting intervention, Stepping Stones Triple P (SSTP), for this population. METHOD: Focus groups were conducted with parents of children with CP (n = 8) and health professionals with experience in working with families of children with CP (n = 5). The discussion was transcribed verbatim and a descriptive thematic analysis was performed. RESULTS: Parents stated that knowing whether a particular behaviour is the result of CP or a behavioural issue is challenging. Parents were also keen to promote communication, independence and socialisation in their child. In addition, parents also discussed the challenges of parenting under time pressure, with additional parenting tasks, under public scrutiny and with grief. Both parents and professionals found SSTP to be a feasible and appropriate intervention for parents of children with CP. CONCLUSIONS: The parents of children with CP in this study faced a range of parenting challenges that may be effectively targeted by a parenting intervention. In addition, parents and health professionals found SSTP content acceptable and feasible for use with parents of children with CP.