This study conducted in Dena County is a population-based cohort study as part of the Prospective Epidemiological Research Studies in Iran (PERSIAN). The specific objectives of this study were to estimate the prevalence of region-specific modifiable risk factors and their associations with the incidence of major non-communicable diseases (NCDs).

This PERSIAN Dena Cohort Study (PDCS) was conducted on 1561 men and 2069 women aged 35–70 years from October 2016 in Dena County, Kohgiluyeh and Boyer-Ahmad Province, Southwest Iran. The overall participation rate was 82.7%.

Out of 3630 participants, the mean age was 50.16 years, 2069 (56.9%) were women and 2092 (57.6%) were rural residents. Females exhibited higher prevalence rates of diabetes, hypertension, fatty liver, psychiatric disorders, thyroiditis, kidney stones, gallstones, rheumatic disease, chronic lung disease, depression and osteoporosis compared with males (p126 mg/dL, low-density lipoprotein >100 mg/dL and haematuria, respectively; most of them were female and urban people (p

PDCS will be planned to re-evaluate NCD-related incidence, all-cause and cause-specific mortality every 5 years, along with annual follow-up for 15 years. Some examples of additional planned studies are evaluation of genetic, environmental risk, spirometry and ECG tests.

Calcium channel blockers (CCB), a commonly prescribed antihypertensive (AHT) medicine, may be associated with increased risk of breast cancer. The proposed study aims to examine whether long-term CCB use is associated with the development of breast cancer and to characterise the dose–response nature of any identified association, to inform future hypertension management.

The study will use data from 2 of Australia’s largest cohort studies; the Australian Longitudinal Study on Women’s Health, and the 45 and Up Study, combined with the Rotterdam Study. Eligible women will be those with diagnosed hypertension, no history of breast cancer and no prior CCB use at start of follow-up (2004–2009). Cumulative dose-duration exposure to CCB and other AHT medicines will be captured at the earliest date of: the outcome (a diagnosis of invasive breast cancer); a competing risk event (eg, bilateral mastectomy without a diagnosis of breast cancer, death prior to any diagnosis of breast cancer) or end of follow-up (censoring event). Fine and Gray competing risks regression will be used to assess the association between CCB use and development of breast cancer using a generalised propensity score to adjust for baseline covariates. Time-varying covariates related to interaction with health services will also be included in the model. Data will be harmonised across cohorts to achieve identical protocols and a two-step random effects individual patient-level meta-analysis will be used.

Ethical approval was obtained from the following Human research Ethics Committees: Curtin University (ref No. HRE2022-0335), NSW Population and Health Services Research Ethics Committee (2022/ETH01392/2022.31), ACT Research Ethics and Governance Office approval under National Mutual Acceptance for multijurisdictional data linkage research (2022.STE.00208). Results of the proposed study will be published in high-impact journals and presented at key scientific meetings.

NCT05972785.

To assess the prevalence and drivers of distress, a composite of burnout, decreased meaning in work, severe fatigue, poor work–life integration and quality of life, and suicidal ideation, among nurses and physicians during the COVID-19 pandemic.

Cross-sectional design to evaluate distress levels of nurses and physicians during the COVID-19 pandemic between June and August 2021.

Cardiovascular and oncology care settings at a Canadian quaternary hospital network.

261 nurses and 167 physicians working in cardiovascular or oncology care. Response rate was 29% (428 of 1480).

Survey tool to measure clinician distress using the Well-Being Index (WBI) and additional questions about workplace-related and COVID-19 pandemic-related factors.

Among 428 respondents, nurses (82%, 214 of 261) and physicians (62%, 104 of 167) reported high distress on the WBI survey. Higher WBI scores (≥2) in nurses were associated with perceived inadequate staffing (174 (86%) vs 28 (64%), p=0.003), unfair treatment, (105 (52%) vs 11 (25%), p=0.005), and pandemic-related impact at work (162 (80%) vs 22 (50%), p

High distress was common among nurses and physicians working in cardiovascular and oncology care settings during the pandemic and linked to factors within and beyond the workplace. These results underscore the complex and contextual aspects of clinician distress, and the need to develop targeted approaches to effectively address this problem.

The study sought to explore the perceptions and attitudes of women in the perinatal period towards the reproductive health services of male midwives.

The study adopted an in-depth exploratory descriptive design for data collection and themes extracted using thematic analysis.

Antenatal and postpartum units of two primary healthcare facilities in the Kwabre-East District of Ghana.

20 women in the perinatal period who were receiving antenatal care and delivery services from the facilities included in the study were recruited through purposive sampling.

Divergent views emerged among our participants regarding the acceptability and utilisation of perinatal services provided by male midwives. Some participants perceived male midwives as patient, supportive, caring, compassionate and skilful at their work while the negative attitude related to some participants perceiving their interactions with male midwives as an opportunity for sexual violation. Positive attitudes emanated from male midwives’ empathetic behaviour, reception, privacy and confidentiality of information. Conversely, negative attitudes arose from a lack of awareness of the changing female gender domination in midwifery, fear and misconceptions. Finally, participants faced various challenges, rooted in culture, which impacted their acceptance of male midwifery services.

Factors influencing participants’ negative perceptions and attitudes towards male midwives were born out of culturally motivated and gender-sensitive stereotyping rather than male professional midwifery competencies. The study outcome provides the basis and the need for a community-based intervention to effect changes in the perception and attitude of women in the perinatal period towards male midwifery practice in the affected communities. Increasing awareness of the existence of male midwives in the communities would contribute to increasing acceptance and utilisation of their services among women in the perinatal period in Ghana.

This study aimed to examine the validity of maternal recall of total number of antenatal care (ANC) visits during pregnancy and factors associated with the accuracy of maternal recall.

This was a longitudinal cohort study conducted from December 2018 through November 2020.

Five government health posts in the Sarlahi district of Southern Nepal.

402 pregnant women between ages 15 and 49 who presented for their first ANC visit at the study health posts.

The observed number of ANC visits (gold standard) and the reported number of ANC visits at the postpartum interview (maternal recall).

On average, women in the study who had a live birth attended 4.7 ANC visits. About 65% of them attended four or more ANC visits during pregnancy as recommended by the Nepal government, and 38.3% of maternal report matched the categorical ANC visits as observed by the gold standard. The individual validity was poor to moderate, with the highest area under the receiver operating characteristic curve (AUC) being 0.69 (95% CI: 0.65 to 0.74) in the 1–3 visits group. Population-level bias (as distinct from individual-level bias) was observed in the 1–3 visits and 4 visits groups, where 1–3 visits were under-reported (inflation factor (IF): 0.69) and 4 ANC visits were highly over-reported (IF: 2.12). The binary indicator ANC4+ (1–3 visits vs 4+ visits) showed better population-level validity (AUC: 0.69; IF: 1.17) compared with the categorical indicators (1–3 visits, 4 visits, 5–6 visits and more than 6 visits). Report accuracy was not associated with maternal characteristics but was related to ANC frequency. Women who attended more ANC visits were less likely to correctly report their total number of visits.

Maternal report of number of ANC visits during pregnancy may not be a valid indicator for measuring ANC coverage. Improvements are needed to measure the frequency of ANC visits.

To assess healthcare providers’ intentions and the associated factors to use mobile phone-based short message service (SMS) to support adherence and care of tuberculosis (TB) patients in the Oromia region of southwest Ethiopia.

An institutional-based cross-sectional study was conducted from October to November 2022.

The study was conducted in public hospitals which include Mettu Karl referral hospital, Dembi Hospital, Bedelle Hospital, Darimu Hospital and Chora Hospital in Ilu Aba Bor and Buno Bedelle zones.

A total of 625 (54.9% male and 45.1% female) health professionals participated in the study. The study participants were selected using a simple random sampling technique. All health professionals permanently working in Ilu Aba Bor and Buno Bedelle zone hospitals were included in this study. However, health professionals with less than 6 months of experience and those who were not present during the data collection period were excluded from this study.

The intention to use mobile phone-based SMS to support TB patients.

Healthcare professionals’ intention to use mobile SMS was 54.4%. Effort expectancy had a significant direct effect on attitude (β=0.162, p

Overall, intention to use of mobile-based SMS was high. Effort expectancy, attitude and facilitating conditions were significant factors that determined healthcare professionals’ behavioural intention to use mobile phone SMS. Effort expectancy had a more significant prediction power than others. As a result, system forms that are easily interactive and applicable should be implemented to improve capacity building and support the adherence and care of TB patients.

Osteogenesis imperfecta (OI) is a rare genetic disease associated with multiple fractures throughout life. It is often treated with osteoporosis medications but their effectiveness at preventing fractures is unknown. The Treatment of Osteogenesis Imperfecta with Parathyroid Hormone and Zoledronic Acid trial will determine if therapy with teriparatide (TPTD) followed by zoledronic acid (ZA) can reduce the risk of clinical fractures in OI.

Individuals aged ≥18 years with a clinical diagnosis of OI are eligible to take part. At baseline, participants will undergo a spine X-ray, and have bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA) at the spine and hip. Information on previous fractures and previous bone targeted treatments will be collected. Questionnaires will be completed to assess pain and other aspects of health-related quality of life (HRQoL). Participants will be randomised to receive a 2-year course of TPTD injections 20 µg daily followed by a single intravenous infusion of 5 mg ZA, or to receive standard care, which will exclude the use of bone anabolic drugs. Participants will be followed up annually, have a repeat DXA at 2 years and at the end of study. Spine X-rays will be repeated at the end of study. The duration of follow-up will range between 2 and 8 years. The primary endpoint will be new clinical fractures confirmed by X-ray or other imaging. Secondary endpoints will include participant reported fractures, BMD and changes in pain and HRQoL.

The study received ethical approval in December 2016. Following completion of the trial, a manuscript will be submitted to a peer-reviewed journal. The results will inform clinical practice by determining if TPTD/ZA can reduce the risk of fractures in OI compared with standard care.

ISRCTN15313991.

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.

The critical shortage of healthcare workers, particularly in rural areas, is a major barrier to quality care for non-communicable diseases (NCD) in low-income and middle-income countries. In this proof-of-concept study, we aimed to test a decentralised model for integrated diabetes and hypertension management in rural Bangladesh to improve accessibility and quality of care.

The study is a single-cohort proof-of-concept study. The key interventions comprised shifting screening, routine monitoring and dispensing of medication refills from a doctor-managed subdistrict NCD clinic to non-physician health worker-managed village-level community clinics; a digital care coordination platform was developed for electronic health records, point-of-care support, referral and routine patient follow-up. The study was conducted in the Parbatipur subdistrict, Rangpur Division, Bangladesh.

A total of 624 participants were enrolled in the study (mean (SD) age, 59.5 (12.0); 65.1% female).

Changes in blood pressure and blood glucose control, patient retention and patient-visit volume at the NCD clinic and community clinics.

The proportion of patients with uncontrolled blood pressure reduced from 60% at baseline to 26% at the third month of follow-up, a 56% (incidence rate ratio 0.44; 95% CI 0.33 to 0.57) reduction after adjustment for covariates. The proportion of patients with uncontrolled blood glucose decreased from 74% to 43% at the third month of follow-up. Attrition rates immediately after baseline and during the entire study period were 29.1% and 36.2%, respectively.

The proof-of-concept study highlights the potential for involving lower-level primary care facilities and non-physician health workers to rapidly expand much-needed services to patients with hypertension and diabetes in Bangladesh and in similar global settings. Further investigations are needed to evaluate the effectiveness of decentralised hypertension and diabetes care.

Self-collected samples (SCS) for sexually transmitted infection (STI) testing have been shown to be feasible and acceptable in high-resource settings. However, few studies have assessed the acceptability of SCS for STI testing in a general population in low-resource settings. This study explored the acceptability of SCS among adults in south-central Uganda.

Nested within the Rakai Community Cohort Study, we conducted semistructured interviews with 36 adults who SCS for STI testing. We analysed the data using an adapted version of the Framework Method.

Overall, SCS was acceptable to both male and female participants, regardless of whether they reported recent STI symptoms. Perceived advantages of SCS over provider-collection included increased privacy and confidentiality, gentleness and efficiency. Disadvantages included the lack of provider involvement, fear of self-harm and the perception that SCS was unhygienic. Most participants preferred provider-collected samples to SCS. Nevertheless, almost all said they would recommend SCS and would do it again in the future.

SCS are acceptable among adults in this low-resource setting and could be offered as an additional option to expand STI diagnostic services.

Geriatric Fracture Centers (GFCs) are dedicated treatment units where care is tailored towards elderly patients who have suffered fragility fractures. The primary objective of this economic analysis was to determine the cost-utility of GFCs compared with usual care centres.

The primary analysis was a cost-utility analysis that measured the cost per incremental quality-adjusted life-year gained from treatment of hip fracture in GFCs compared with treatment in usual care centres from the societal perspective over a 1-year time horizon. The secondary analysis was a cost-utility analysis from a societal perspective over a lifetime time horizon. We evaluated these outcomes using a cost-utility analysis using data from a large multicentre prospective cohort study comparing GFCs versus usual care centres that took place in Austria, Spain, the USA, the Netherlands, Thailand and Singapore.

GFCs may be cost-effective in the long term, while providing a more comprehensive care plan. Patients in usual care centre group were slightly older and had fewer comorbidities. For the 1-year analysis, the costs per patient were slightly lower in the GFC group (–$646.42), while the quality-adjusted life-years were higher in the usual care centre group (+0.034). The incremental cost-effectiveness ratio was $18 863.34 (US$/quality-adjusted life-year). The lifetime horizon analysis found that the costs per patient were lower in the GFC group (–$7210.35), while the quality-adjusted life-years were higher in the usual care centre group (+0.02). The incremental cost-effectiveness ratio was $320 678.77 (US$/quality-adjusted life-year).

This analysis found that GFCs were associated with lower costs compared with usual care centres. The cost-savings were greater when the lifetime time horizon was considered. This comprehensive cost-effectiveness analysis, using data from an international prospective cohort study, found that GFC may be cost-effective in the long term, while providing a more comprehensive care plan. A greater number of major adverse events were reported at GFC, nevertheless a lower mortality rate associated with these adverse events at GFC. Due to the minor utility benefits, which may be a result of greater adverse event detection within the GFC group and much greater costs of usual care centres, the GFC may be cost-effective due to the large cost-savings it demonstrated over the lifetime time horizon, while potentially identifying and treating adverse events more effectively. These findings suggest that the GFC may be a cost-effective option over the lifetime of a geriatric patient with hip fracture, although future research is needed to further validate these findings.

Economic, level 2.

NCT02297581.