Randomised controlled trials (RCTs) with a placebo comparator are considered the gold standard study design when evaluating healthcare interventions. These are challenging to design and deliver in surgery. Guidance recommends pilot and feasibility work to optimise main trial design and conduct; however, the extent to which this occurs in surgery is unknown.

A systematic review identified randomised placebo-controlled surgical trials. Articles published from database inception to 31 December 2020 were retrieved from Ovid-MEDLINE, Ovid-EMBASE and CENTRAL electronic databases, hand-searching and expert knowledge. Pilot/feasibility work conducted prior to the RCTs was then identified from examining citations and reference lists. Where studies explicitly stated their intent to inform the design and/or conduct of the future main placebo-controlled surgical trial, they were included. Publication type, clinical area, treatment intervention, number of centres, sample size, comparators, aims and text about the invasive placebo intervention were extracted.

From 131 placebo surgical RCTs included in the systematic review, 47 potentially eligible pilot/feasibility studies were identified. Of these, four were included as true pilot/feasibility work. Three were original articles, one a conference abstract; three were conducted in orthopaedic surgery and one in oral and maxillofacial surgery. All four included pilot RCTs, with an invasive surgical placebo intervention, randomising 9–49 participants in 1 or 2 centres. They explored the acceptability of recruitment and the invasive placebo intervention to patients and trial personnel, and whether blinding was possible. One study examined the characteristics of the proposed invasive placebo intervention using in-depth interviews.

Published studies reporting feasibility/pilot work undertaken to inform main placebo surgical trials are scarce. In view of the difficulties of undertaking placebo surgical trials, it is recommended that pilot/feasibility studies are conducted, and more are reported to share key findings and optimise the design of main RCTs.

CRD42021287371.

To outline current knowledge regarding workplace-based learning about health promotion in individual patient care.

Scoping review.

PubMed, ERIC, CINAHL and Web of Science from January 2000 to August 2023.

We included articles about learning (activities) for healthcare professionals (in training), about health promotion in individual patient care and in the context of workplace-based learning.

The studies were evaluated using a charting template and were analysed thematically using a template based on Designable Elements of Learning Environments model.

From 7159 studies, we included 31 that described evaluations of workplace-based learning about health promotion, around a variety of health promotion topics, for different health professions. In the articles, health promotion was operationalised as knowledge, skills or attitudes related to specific lifestyle factors or more broadly, with concepts such as health literacy, advocacy and social determinants of health. We assembled an overview of spatial and instrumental, social, epistemic and temporal elements of learning environments in which health promotion is learnt.

The studies included in our analysis varied greatly in their approach to health promotion topics and the evaluation of learning outcomes. Our findings suggest the importance of providing opportunities for health profession learners to engage in authentic practice situations and address potential challenges they may experience translating related theory into practice. Additionally, our results highlight the need for conscious and articulated integration of health promotion in curricula and assessment structures. We recommend the exploration of opportunities for health profession students, professionals and patients to learn about health promotion together. Additionally, we see potential in using participatory research methods to study future health promotion learning.

Open Science Framework, https://doi.org/10.17605/OSF.IO/6QPTV.

Women with type 2 diabetes (T2DM) are more likely to experience adverse reproductive outcomes, yet preconception care can significantly reduce these risks. For women with T2DM, preconception care includes reproductive planning and patient education on: (1) the importance of achieving glycaemic control before pregnancy, (2) using effective contraception until pregnancy is desired, (3) discontinuing teratogenic medications if pregnancy could occur, (4) taking folic acid, and (5) managing cardiovascular and other risks. Despite its importance, few women with T2DM receive recommended preconception care.

We are conducting a two-arm, clinic-randomised trial at 51 primary care practices in Chicago, Illinois to evaluate a technology-based strategy to ‘hardwire’ preconception care for women of reproductive age with T2DM (the PREPARED (Promoting REproductive Planning And REadiness in Diabetes) strategy) versus usual care. PREPARED leverages electronic health record (EHR) technology before and during primary care visits to: (1) promote medication safety, (2) prompt preconception counselling and reproductive planning, and (3) deliver patient-friendly educational tools to reinforce counselling. Post-visit, text messaging is used to: (4) encourage healthy lifestyle behaviours. English and Spanish-speaking women, aged 18–44 years, with T2DM will be enrolled (N=840; n=420 per arm) and will receive either PREPARED or usual care based on their clinic’s assignment. Data will be collected from patient interviews and the EHR. Outcomes include haemoglobin A1c (primary), reproductive knowledge and self-management behaviours. We will use generalised linear mixed-effects models (GLMMs) to evaluate the impact of PREPARED on these outcomes. GLMMs will include a fixed effect for treatment assignment (PREPARED vs usual care) and random clinic effects.

This study was approved by the Northwestern University Institutional Review Board (STU00214604). Study results will be published in journals with summaries shared online and with participants upon request.

ClinicalTrials.gov Registry (NCT04976881).

To investigate the accumulation of adversities (duration of exposure to any, economic, psychosocial) across the lifecourse (birth to 63 years) on cognitive function in older age, and the mediating role of mental health.

National birth cohort study.

Great Britain.

5362 singleton births within marriage in England, Wales and Scotland born within 1 week of March 1946, of which 2131 completed at least 1 cognitive assessment.

Cognitive assessments included the Addenbrooke’s Cognitive Examination-III, as a measure of cognitive state, processing speed (timed-letter search task), and verbal memory (word learning task) at 69 years. Scores were standardised to the analytical sample. Mental health at 60–64 years was assessed using the 28-item General Health Questionnaire, with scores standardised to the analytical sample.

After adjusting for sex, increased duration of exposure to any adversity was associated with decreased performance on cognitive state (β=–0.39; 95% CI –0.59 to –0.20) and verbal memory (β=–0.45; 95% CI –0.63 to –0.27) at 69 years, although these effects were attenuated after adjusting for further covariates (childhood cognition and emotional problems, educational attainment). Analyses by type of adversity revealed stronger associations from economic adversity to verbal memory (β=–0.54; 95% CI –0.70 to –0.39), with a small effect remaining even after adjusting for all covariates (β=–0.18; 95% CI –0.32 to –0.03), and weaker associations from psychosocial adversity. Causal mediation analyses found that mental health mediated all associations between duration of exposure to adversity (any, economic, psychosocial) and cognitive function, with around 15% of the total effect of economic adversity on verbal memory attributable to mental health.

Improving mental health among older adults has the potential to reduce cognitive impairments, as well as mitigate against some of the effect of lifecourse accumulation of adversity on cognitive performance in older age.

To describe the 5 year work status in patients referred for suspected work-related common mental disorders. To develop a prognostic model.

Register-based nationwide longitudinal follow-up study.

All departments of occupational medicine in Denmark.

17 822 patients aged 18–67 years, seen for the first time at a Department of Occupational Medicine in Denmark from 2000 to 2013 and diagnosed with stress, depression, post-traumatic stress disorder, anxiety or other mental disorders.

All patients were seen for diagnostic assessment and causal evaluation of the work-relatedness of their disorders. Some departments offered patients with stress disorders psychological treatment, which, however, was not organised according to patient selection or type of treatment.

Register data were collected for 5 year periods before and after the patients’ first assessment at a department. Weekly percentages of patients are presented according to work status. The outcome in the prognostic model was a high Work Participation Score (ie, working>75% of potential work weeks/year) at 5 year follow-up.

For all subgroups of patients, a high proportion were working (>75%) 1–5 years before assessment, and all experienced a large reduction in work status at time of assessment. At 1 year follow-up, almost 60% of patients with stress were working, whereas in the other patient subgroups, less than 40% were working. In the following years, practically no increase was observed in the percentage of patients working in any of the subgroups. Based on these 5 year follow-up data, we developed a work participation model with only moderate discrimination and calibration.

In Denmark, not all return to previous work status 5 years after a referral due to a suspected work-related common mental disorder. We developed a prognostic model with only moderate discrimination and calibration for long-term work participation after suggested work-related common mental disorders.

Epidemics and pandemics have major impacts on ED care. Studies examining the COVID-19 pandemic noted large early US ED visit declines.1 In some...