To compare differences in recruitment and attrition between placebo control randomised trials of surgery, and trials of the same surgical interventions and conditions that used non-operative (non-placebo) controls.

Meta-epidemiological study.

Randomised controlled trials were identified from an electronic search of MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials from their inception date to 21 November 2018.

Placebo control trials evaluating efficacy of any surgical intervention and non-operative control trials of the same surgical intervention were included in this study. 25 730 records were retrieved from our systemic search, identifying 61 placebo control and 38 non-operative control trials for inclusion in analysis.

Primary outcome measures were recruitment and attrition. These were assessed in terms of recruitment rate (number of participants enrolled, as a proportion of those eligible) and overall attrition rate (composite of dropout, loss to follow-up and cross-overs, expressed as proportion of total sample size). Secondary outcome measures included participant cross-over rate, dropout and loss to follow-up.

Unadjusted pooled recruitment and attrition rates were similar between placebo and non-operative control trials. Study characteristics were not significantly different apart from time to primary timepoint which was shorter in studies with placebo controls (365 vs 274 days, p=0.006). After adjusting for covariates (follow-up duration and number of timepoints), the attrition rate of placebo control trials was almost twice as high compared with non-operative controlled-trials (incident rate ratio (IRR) (95% CI) 1.8 (1.1 to 3.0), p=0.032). The incorporation of one additional follow-up timepoint (regardless of follow-up duration) was associated with reduced attrition in placebo control surgical trials (IRR (95% CI) 0.64 (0.52 to 0.79), p

Placebo control trials of surgery have similar recruitment issues but higher attrition compared with non-operative (non-placebo) control trials. Study design should incorporate strategies such as increased timepoints for given follow-up duration to mitigate losses to follow-up and dropout.

CRD42019117364.

Hip osteoarthritis (OA) is a major cause of pain and disability worldwide. Lack of effective therapies may reflect poor knowledge on its aetiology and risk factors, and result in the management of end-stage hip OA with costly joint replacement. The Worldwide Collaboration on OsteoArthritis prediCtion for the Hip (World COACH) consortium was established to pool and harmonise individual participant data from prospective cohort studies. The consortium aims to better understand determinants and risk factors for the development and progression of hip OA, to optimise and automate methods for (imaging) analysis, and to develop a personalised prediction model for hip OA.

World COACH aimed to include participants of prospective cohort studies with ≥200 participants, that have hip imaging data available from at least 2 time points at least 4 years apart. All individual participant data, including clinical data, imaging (data), biochemical markers, questionnaires and genetic data, were collected and pooled into a single, individual-level database.

World COACH currently consists of 9 cohorts, with 38 021 participants aged 18–80 years at baseline. Overall, 71% of the participants were women and mean baseline age was 65.3±8.6 years. Over 34 000 participants had baseline pelvic radiographs available, and over 22 000 had an additional pelvic radiograph after 8–12 years of follow-up. Even longer radiographic follow-up (15–25 years) is available for over 6000 of these participants.

The World COACH consortium offers unique opportunities for studies on the relationship between determinants/risk factors and the development or progression of hip OA, by using harmonised data on clinical findings, imaging, biomarkers, genetics and lifestyle. This provides a unique opportunity to develop a personalised hip OA risk prediction model and to optimise methods for imaging analysis of the hip.

Postoperative pancreatic fistula (POPF) remains the most common and serious complication after distal pancreatectomy. Many attempts at lowering fistula rates have led to unrewarding insignificant results as still up to 30% of the patients suffer from clinically relevant POPF. Therefore, the development of new innovative methods and procedures is still a cornerstone of current surgical research.

The cavitron ultrasonic surgical aspirator (CUSA) device is a well-known ultrasound-based parenchyma transection method, often used in liver and neurosurgery which has not yet been thoroughly investigated in pancreatic surgery, but the first results seem very promising.

The CUSA-1 trial is a randomised controlled pilot trial with two parallel study groups. This single-centre trial is assessor and patient blinded. A total of 60 patients with an indication for open distal pancreatectomy will be intraoperatively randomised after informed consent. The patients will be randomly assigned to either the control group with conventional pancreas transection (scalpel or stapler) or the experimental group, with transection using the CUSA device. The primary safety endpoint of this trial will be postoperative complications ≥grade 3 according to the Clavien-Dindo classification. The primary endpoint to investigate the effect will be the rate of POPF within 30 days postoperatively according to the ISGPS definition. Further perioperative outcomes, including postpancreatectomy haemorrhage, length of hospital stay and mortality will be analysed as secondary endpoints.

Based on the available literature, CUSA may have a beneficial effect on POPF occurrence after distal pancreatectomy. The rationale of the CUSA-1 pilot trial is to investigate the safety and feasibility of the CUSA device in elective open distal pancreatectomy compared with conventional dissection methods and gather the first data on the effect on POPF occurrence. This data will lay the groundwork for a future confirmatory multicentre randomised controlled trial.

The CUSA-1 trial protocol was approved by the ethics committee of the University of Heidelberg (No. S-098/2022). Results will be published in an international peer-reviewed journal and summaries will be provided in lay language to study participants and their relatives.

DRKS00027474.

Emergency medical services (EMSs) personnel are at high risk for developing work-related musculoskeletal disorders (WMSDs). However, no studies have yet investigated the prevalence and effect of these disorders on the Jordanian EMS personnel. Therefore, this study aimed to determine the prevalence of WMSDs among Jordanian EMS personnel and its associated factors.

This study used a cross-sectional design. Participants were asked to complete a self-administrated and validated questionnaire to measure the WMSDs, including a demographic survey and the Nordic Musculoskeletal Questionnaire. Descriptive and multivariable regression analyses were used.

The Jordanian Civil Defence stations in the main cities of Jordan.

The sample consisted of 435 EMS workers which were obtained across the country of Jordan. A total of 79.0% of the participants were male, with a mean age of 27.9 (±4.3 SD) years.

The pain in the lower back (308, 70.8%) and neck (252, 57.9%) were the most reported in the last 12 months. Furthermore, about half of the participants reported having pain in their upper back (234, 53.8%), knee (227, 52.2%) and shoulder (226, 52.0%) pain in the last 12 months. Overall, WMSDs in at least one body part were significantly associated with age, experience, being a male, increased body mass index and lower educational level.

There is a high prevalence of musculoskeletal complaints among EMS personnel. Multiple variables may be incorporated into a national prevention campaign and professional development programme to educate EMS personnel on avoiding WMSDs.

The aim of this study was to investigate the prevalence of missed nursing care and its associated factors among public hospitals in Bahir Dar City, Northwest Ethiopia.

An institution-based cross-sectional study was conducted among 369 randomly selected nurses.

The study was conducted in primary and secondary-level public hospitals in Bahir Dar City.

Nurses who had worked in hospitals in Bahir Dar City were included.

No intervention was needed in this study.

A binary logistic regression model was used for statistical analysis. Statistical significance of the association between outcome variables and independent variables was declared at a p value of

The prevalence of missed nursing care in this study was 46.3% (95% CI: 41.7% to 50.9%). The activities most frequently missed were physical examination (56.4%), patient discharge planning and teaching (50.9%), providing emotional support to the patient and family (50.8%), monitoring input and output (50.2%), assisting with patient ambulation (48.5%) and documentation (48%). Factors associated with missed nursing care include: male professionals (adjusted OR (AOR): 2.9, 95% CI: 1.8 to 4.8), those who had not received on-the-job training (AOR: 2.2, 95% CI: 1.4 to 3.6), those who worked full 24-hour shifts (AOR: 3.7, 95% CI: 2.0 to 6.5), those who were dissatisfied with the level of teamwork (AOR: 4.6, 95% CI: 2.8 to 7.6) and those who had an intention to leave the nursing profession (AOR: 1.8, 95% CI: 1.1 to 2.9). These factors were statistically associated with missed nursing care.

A significant proportion of nurses missed essential nursing care activities. Efforts should be made to enhance training, improve teamwork among nurses, provide stability and adjust work shifts to mitigate this issue.

Incisional hernia (IH) is a prevalent and potentially dangerous complication of abdominal surgery, especially in high-risk groups. Mesh reinforcement of the abdominal wall has been studied as a potential intervention to prevent IHs. Randomised controlled trials (RCTs) have demonstrated that prophylactic mesh reinforcement after abdominal surgery, in general, is effective and safe. In patients with abdominal aortic aneurysm (AAA), prophylactic mesh reinforcement after open repair has not yet been recommended in official guidelines, because of relatively small sample sizes in individual trials. Furthermore, the identification of subgroups that benefit most from prophylactic mesh placement requires larger patient numbers. Our primary aim is to evaluate the efficacy and effectiveness of the use of a prophylactic mesh after open AAA surgery to prevent IH by performing an individual patient data meta-analysis (IPDMA). Secondary aims include the evaluation of postoperative complications, pain and quality of life, and the identification of potential subgroups that benefit most from prophylactic mesh reinforcement.

We will conduct a systematic review to identify RCTs that study prophylactic mesh placement after open AAA surgery. Cochrane Central Register of Controlled Trials, MEDLINE Ovid, Embase, Web of Science Core Collection and Google Scholar will be searched from the date of inception onwards. RCTs must directly compare primary sutured closure with mesh closure in adult patients who undergo open AAA surgery. Lead authors of eligible studies will be asked to share individual participant data (IPD). The risk of bias (ROB) for each included study will be assessed using the Cochrane ROB tool. An IPDMA will be performed to evaluate the efficacy, with the IH rate as the primary outcome. Any signs of heterogeneity will be evaluated by Forest plots. Time-to-event analyses are performed using Cox regression analysis to evaluate risk factors.

No new data will be collected in this study. We will adhere to institutional, national and international regulations regarding the secure and confidential sharing of IPD, addressing ethics as indicated. We will disseminate findings via international conferences, open-source publications in peer-reviewed journals and summaries posted online.

CRD42022347881.

The new WHO Labour Care Guide (LCG), also regarded as the ‘next-generation partograph’, is a core component of 2018 WHO consolidated guidelines on intrapartum care for positive childbirth experience. The Ugandan Ministry of Health is in the process of adopting the new WHO LCG with no local context-specific data to inform this transition. We will explore potential barriers and facilitators to healthcare providers’ (HCPs) sustained engagement in labour monitoring in Mbarara city, Southwestern Uganda, and use the data to refine the new WHO LCG and develop a suitable implementation strategy to effectively integrate LCG into routine maternity care in Uganda. We shall then assess effectiveness, validity and other preliminary implementation outcomes of using the new LCG in detecting prolonged labour.

The study will use a mixed-methods approach to identify key LCG user perspectives to refine and customise the WHO LCG among 120 HCPs and stakeholders involved in maternity care and labour monitoring within facilities in Southwestern Uganda. The refined prototype will be deployed and used to monitor labour in all 14 basic and comprehensive emergency obstetric and newborn care facilities in the study area. We will review labour outcomes of 520 patients monitored using the new LCG and compare these outcomes with a historical cohort of 520 patients monitored using the partograph. The main effectiveness outcome will be the proportion of women diagnosed with prolonged labour and/or obstructed labour.

Ethical approval was obtained from the Mbarara University of Science and Technology Research Ethics Committee (MUST-2023-808) and Uganda National Council for Science and Technology (HS2864ES). We shall obtain written informed consent from each participant. The results of this study will be published in international peer-reviewed journals and presented to the Ugandan Ministry of Health as policy briefs and at selected national/international conferences.

NCT05979194.

The objective of this study was to explore how people living with obesity who use obesity services perceive healthcare professionals’ (HCPs) online representation of the disease on social media. By exploring their perspective, we aimed to develop a framework to inform good practice around social media use for HCPs.

This was a qualitative study using a phenomenological framework. Following in-depth semi-structured interviews, analysis was undertaken to identify superordinate themes relating to how HCPs portray living with obesity online.

Patient advocacy organisation (The Irish Coalition for People Living with Obesity) and three clinical sites offering obesity treatment in Ireland.

15 adult participants comprising of 12 women and 3 men who use social media and are living with obesity and who use obesity services.

Three key themes of how people living with obesity who use obesity services perceive HCP’s online representation of the disease. (1) Negative experiences of HCPs—participants describe encountering weight stigma and bias on social media from HCPs that they characterised as simplistic and outdated conceptualisations. These engender shame, fear and anger. (2) Positive experience of HCPs—participants report social media allows HCPs to educate and inform public perception of obesity. Positive online experiences lead to feelings of inclusion, understanding and encouragement. (3) Expectations of HCPs—qualifications, professional titles and academic association affected the perceived trustworthiness of information and its impact on readers. Participants feel there is a duty of care for HCPs in obesity medicine to advocate and be active online to provide accurate medical information.

HCP’s use of social media has a powerful impact on people with obesity who use healthcare and obesity services. Social media is a key tool in obesity awareness and education. We propose the ‘3E’ framework—Empower, Evidence-Based and Educate and be educated to guide HCPs’ social media use.

On 6 April 2022, the UK government implemented mandatory kilocalorie (kcal) labelling regulations for food and drink products sold in the out-of-home food sector (OHFS) in England. Previous assessments of kcal labelling practices in the UK OHFS found a low prevalence of voluntary implementation and poor compliance with labelling recommendations. This study aimed to examine changes in labelling practices preimplementation versus post implementation of mandatory labelling regulations in 2022.

In August–December 2021 (preimplementation) and August–November 2022 (post implementation), large OHFS businesses (250 or more employees) subject to labelling regulations were visited. At two time points, a researcher visited the same 117 food outlets (belonging to 90 unique businesses) across four local authorities in England. Outlets were rated for compliance with government regulations for whether kcal labelling was provided at any or all point of choice, provided for all eligible food and drink items, provided per portion for sharing items, if labelling was clear and legible and if kcal reference information was displayed.

There was a significant increase (21% preimplementation vs 80% post implementation, OR=40.98 (95% CI 8.08 to 207.74), p

The number of large businesses in the OHFS providing kcal labelling increased following the implementation of mandatory labelling regulations. However, around one-fifth of eligible outlets sampled were not providing kcal labelling 4–8 months after the regulations came into force, and the majority of businesses only partially complied with government guidance. More effective enforcement may be required to further improve kcal labelling practices in the OHFS in England.

Study protocol and analysis strategy preregistered on Open Science Framework (https://osf.io/pfnm6/).

To examine family planning through the community’s perception, belief system and cultural impact; in addition to identifying the determining factors for family planning uptake.

A descriptive exploratory study.

Three communities were selected from three local government areas, each in the three senatorial districts in Ekiti State.

The study was conducted among young unmarried women in the reproductive age group who were sexually active as well as married men and women in the reproductive age group who are currently living with their partners and were sexually active.

Eight focus group discussions were conducted in the community in 2019 with 28 male and 50 female participants. The audio recordings were transcribed, triangulated with notes and analysed using QSR NVivo V.8 software. Community perception, beliefs and perceptions of the utility of family planning, as well as cultural, religious and other factors determining family planning uptake were analysed.

The majority of the participants had the perception that family planning helps married couple only. There were diverse beliefs about family planning and mixed reactions with respect to the impact of culture and religion on family planning uptake. Furthermore, a number of factors were identified in determining family planning uptake—intrapersonal, interpersonal and health system factors.

The study concluded that there are varied reactions to family planning uptake due to varied perception, cultural and religious beliefs and determining factors. It was recommended that more targeted male partner engagement in campaign would boost family planning uptake.