Study within a trial of electronic versus paper-based Patient-Reported oUtcomes CollEction (SPRUCE): study protocol for a partially randomised patient preference study

Introduction
Patient-reported outcomes (PRO) are currently collected from trial participants using paper questionnaires by the Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU). Streamlining PRO collection using electronic questionnaires (ePRO) may improve data collection and patient experience. Here, we outline our protocol for a Study within a trial of electronic versus paper-based Patient-Reported oUtcomes CollEction (SPRUCE), which investigates the acceptability of ePRO in oncology clinical trials.

Methods and analysis
SPRUCE was developed alongside patient and public contributors. SPRUCE runs in multiple host trials with a partially randomised patient preference design, allowing participants to be randomised or choose their preference of electronic or paper questionnaires. Questionnaires are scheduled in accordance with host trial follow-up. The primary objective will assess differences in return rates (compliance) between ePRO and paper PROs at the first timepoint post-host trial intervention in the randomised group. Paper PRO compliance is expected to be 90%. 244 randomised participants are required to exclude ≤80% compliance rates with ePRO (10% non-inferiority margin, with 80% power and one-sided alpha=0.05). SPRUCE aims to assess acceptability of ePRO in oncology clinical trials, establish whether ePRO is acceptable to ICR-CTSU trial participants and can capture complete PRO data, consistent with paper PROs.

Ethics and dissemination
The SPRUCE protocol (ICR-CTSU/2021/10074) was approved by the Coventry and Warwick Central Research Ethics Committee (21/WM/0223) on 21 October 2021. Results will be disseminated via presentations, publications and lay summaries. No participant identifiable data will be included.

Trial registration
SWAT169.

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Settembre 2023

Identification of factors associated with non-adherence to recommended COVID-19 preventive behaviours: a cross-sectional study based on a survey among 1004 French primary care professionals

Objectives
Since the beginning of the COVID-19 pandemic, adherence to preventive behaviours to limit virus spread has been a major issue. The study objective was to identify factors associated with non-adherence to preventive behaviours among general practitioners (GPs) during the COVID-19 pandemic using data from a questionnaire completed during the French National Congress of General Medicine in June 2021.

Design
This descriptive study relied on data collected with a questionnaire during the national congress on general medicine in Bordeaux, France, from 16–18 June 2021.

Setting
The study was conducted in primary care in France.

Participants
Out of a total of 1004 GPs and GP trainees, 755 completed the questionnaire during conferences and 249 were contacted by mail.

Results
The questionnaire included questions on sociodemographic characteristics and COVID-19 related preventive behaviours, beliefs and experiences. Answers to questions that explored the Health Belief Model components were selected and then compared among participants who reported appropriate preventive behaviours (wearing face masks and social distancing) and participants who reported non-adherence. Analysis was based on multivariate logistic regression.
The responders’ mean age was 35.8 years; 61.64% were women, 61.9% were practising GPs and 37.2% were GP trainees. Moreover, 96.6% of participants had completed the COVID-19 vaccination schedule. Non-adherence (reported by 72/1004 participants) was more frequent among smokers (OR=2.57, 95% CI 1.29 to 4.83, p=0.005) and younger participants (OR=0.95, 95% CI 0.92 to 0.98, p=0.005). Complete COVID-19 vaccination or a previous infection was not associated with non-adherence and has been poorly described.

Conclusion
More studies are needed to confirm the factors involved in the adoption of COVID-19 preventive behaviours by healthcare professionals and to explore the beliefs and barriers to the adoption of these behaviours.

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Agosto 2023

British Society of Gastroenterology interim framework for addressing the COVID-19-related backlog in inflammatory bowel disease colorectal cancer surveillance

The COVID-19 pandemic has had profound implications across the breadth of national healthcare services. Inflammatory bowel disease (IBD) continues to carry an increased risk of colon cancer and national protocols for endoscopic surveillance are in place. Elective procedures such as IBD surveillance were stopped during the COVID-19 pandemic and have been slow to be re-started. We are acutely aware of the pressures on endoscopy services at the present time which is unlikely to improve at the pace needed for services to fully recover. At such times, we need to target this scarce resource to those who need it most, aligned to the principles of ethical healthcare which state that when resources are limited, they should be used to provide the most benefit for as great a number of people as possible. With this in mind, we propose an optional interim framework to aid risk stratification of patients on the…

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Agosto 2023

Distinct cardiovascular and cancer burdens associated with social position, work environment and unemployment: a cross-sectional and retrospective study in a large population-based French cohort

Objectives
Distinguish the respective effects of social position, work environment and unemployment on cardiovascular and cancer risks.

Design
A cross-sectional and retrospective observational study.

Setting
A population-based French cohort (CONSTANCES).

Participants
130 197 adults enrolled between 2012 and 2021 without missing values.

Primary outcome measures
The associations of social position, work environment and unemployment exposure with the prevalence of cardiovascular events and cancers simultaneously tested using logistic regression models adjusting for common risk factors.

Results
While social position, work environment and unemployment exposure are strongly inter-related with each other, they are not linked to the same cardiovascular and cancer outcomes. Low social position and long unemployment duration are significantly associated with an increased prevalence of angina pectoris, myocardial infarction and peripheral arterial disease (OR=1.22 to 1.90, p

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Luglio 2023