Non-specific chronic low back pain is a leading cause of disability-adjusted life-years (DALYs) with a lifetime prevalence of 80%–85%. Although many modalities of treating chronic low back pain are available, pharmacotherapy remains a very important treatment modality, according to many recognised guidelines. Each of these pharmacological agents has evidence supporting its efficacy in treating chronic low back pain, and each of them is associated with side effects. At present, no study has unified these two outcomes or ranked them from the most effective to the least effective. Thus, this study aims to identify pharmacological agents that rank best by conducting multivariate bivariate network meta-analysis.

Four databases (Medline/Pubmed, Cochrane Central Register for Controlled Trials, Cochrane Database for Systematic Reviews and CINAHL) will be systematically searched from their inception to 31 July 2024 for randomised control trials that meet the inclusion criteria. Appropriate data will be extracted from the relevant studies, including the two outcomes of interest: the pain intensity score and the proportion of patients who withdrew from the study because of adverse events. A bivariate Bayesian network meta-analysis will be used to combine the two outcomes of interest to form a single probability that will rank the pharmacotherapy agents from the most effective and safe to the least. The studies will be assessed for risk of bias, and their evidence will be graded using the Grading of Recommendations Assessment, Development, and Evaluation assessment tool. Inconsistency, which is a key assumption of network meta-analysis, will be assessed using both local and global methods.

This systematic review is based on already published data, so it does not require ethical approval. The findings from the review, after completion, will be disseminated via peer-reviewed publications.

CRD42024569192.

The TRAjectory of knee heaLth in runners (TRAIL) study is a prospective cohort study investigating the long-term knee health trajectories of runners with and without a heightened osteoarthritis risk. This study aims to describe the recruitment results and baseline characteristics of the TRAIL cohort.

Runners aged 18–50 years and running ≥3 times and ≥10 km per week on average in the past 6 months were eligible. Participants were recruited via running podcasts, running clubs and social media between July 2020 and August 2023. Data were collected at study enrolment and at a face-to-face baseline testing session, which occurred a median of 33 weeks (IQR 18 to 86 weeks) after enrolment. Follow-up data collection is ongoing.

Out of 462 runners who completed an online registration form, 268 runners enrolled, of which 135 had a history of knee surgery (46% females) and 133 were non-surgical controls (50% females). 60% of the surgery group had undergone anterior cruciate ligament reconstruction, 33% meniscus and/or cartilage surgery, and 7% other knee surgery. 54 participants previously enrolled were unable to continue in the study before attending baseline data collection. Of the 214 runners who remained in the study and attended baseline data collection, 108 had a history of knee surgery (49% females) and 106 did not have a history of knee surgery (51% females).

Participants will be followed for 10 years through ongoing patient-reported outcomes and continuous monitoring of training loads using wearable devices. At baseline, 4- and 10-year follow-up, knee MRI and knee-health patient-reported outcomes will be collected to evaluate structural and symptomatic knee osteoarthritis progression. Data will inform guidelines for safe running practices and rehabilitation post-knee surgery.

To assess the feasibility of delivering the swallowing prehabilitation intervention known as Swallowing Intervention Package: Self-Monitoring, Assessment and Rehabilitation Training (SIP SMART) within the National Health Service (NHS) head and neck cancer care pathway.

Two-arm cluster-randomised pilot trial: SIP SMART2 trial.

Adults newly diagnosed with stage II–IV head and neck cancer receiving curative treatment within a multidisciplinary team who agree to participate.

Six hospitals were randomised. Trained clinicians at the intervention sites delivered the manualised SIP SMART intervention, while standard care was provided at care as usual (CAU) sites. The intervention included two 45-minute consultations incorporating an X-ray swallow assessment, tailored exercises/advice and specific behaviour change strategies while CAU involved a single consultation of information giving and provision of a generic exercise sheet.

Study outcomes related to feasibility of the cluster-randomised design, recruitment of both sites and patients and completeness of clinical and health economic data collected at baseline, 4 weeks, 12 weeks and 24 weeks after treatment.

12 hospitals expressed interest and six were randomised (50%) and provided data to the point of study completion. Patient recruitment across all sites (n=76) reached the target, although two sites fell short of their individual targets. The proportion of people with HNC recruited versus those eligible for each arm was 39% (95% CI 29 to 49) for SIP SMART group and 55% (95% CI 43 to 66) for CAU. The end point data at 24 weeks were completed for 50% (95% CI 33 to 67) for SIP SMART and 78% (95% CI 62 to 89) for CAU. Adherence to the intervention was above 50% at all time points. No harms related to the intervention were reported.

It is feasible to deliver the SIP SMART intervention embedded within the NHS cancer care pathway using a cluster-randomised design. A future trial will be optimised for efficiency in set-up and follow-up data collection based on these findings and learnings from the accompanying process evaluation study.

ISRCTN12377415.

Interest in workplace bullying (WPB) has been steadily growing with a focus on understanding its consequences as well as prevalence rates in different occupations and across different countries with varying cultural contexts. Research in the Middle East remains limited, especially in Lebanon. The scarcity of data from the Lebanese healthcare sector underscores the need to better understand WPB in this unique sociocultural and organisational environment.

The primary aim of this study is to investigate the prevalence of WPB among healthcare providers and hospital staff in Greater Beirut. The secondary aim is to investigate the relationship between WPB, psychological well-being, burnout and sick leaves in the Lebanese cultural context.

A cross-sectional study design was conducted.

Seven hospitals in Greater Beirut took part in the study, including six private hospitals and one public hospital.

A total of 958 participants aged 18–64 were recruited using stratified proportionate non-random sampling. Stratification by hospital size and department aimed to ensure broad representation of nursing and support staff across institutions. The participants included nursing and supporting staff, of which 26.3% were males and 73.7% were females. Those employed for less than 6 months were excluded.

The Arabic versions of each of the Negative Acts Questionnaire-Revised (NAQ-R), the General Health Questionnaire (GHQ-12) and the Copenhagen Burnout Inventory (CBI) were administered. These instruments were selected for their established reliability and widespread use in cross-cultural occupational health research. Surveys were administered via paper-and-pencil (six hospitals) and online (one hospital). Prevalence of bullying using the NAQ-R cut-off scores was first calculated and then their respective thresholds identified using receiver operating characteristic analysis. Pearson’s correlation coefficient was used to evaluate the relationship between the NAQ-R and the GHQ-12, CBI and number of sick leaves.

Using the lower threshold as a cut-off on the NAQ-R, 35.1% of participants were classified as bullied. When applying the higher threshold as a cut-off, the percentage was slightly lower but remained comparable at 32.4%. Results showed that across the two outcomes, those who were bullied both when using a lower threshold and upper threshold were significantly more distressed and burnt out (pt(df) = –8.43, p±1.96; Upper threshold: ² (4, N=902)=9.963, p=0.019, Standardised residual for 6–10 days=2.2>±1.96).

Findings yielded lower prevalence rates of WPB among nurses and the entire sample as compared with research carried out in the Arab region. Our study further supports the impact of culture on the perpetuation of WPB and the uniqueness of Lebanon’s culture on influencing this prevalence. Results indicated that participants who were bullied were significantly more distressed, more burnt out and reported taking up more sick leaves. These findings highlight the need to consider local workplace culture when addressing bullying and reinforce the significant psychological and occupational toll bullying takes on affected individuals. Healthcare institutions are encouraged to implement and reinforce clear antibullying policies, WPB prevention strategies and confidential reporting mechanisms. Future research should explore longitudinal patterns of bullying, obtain a more nationally representative sample and examine the effectiveness of targeted interventions to create safer, more supportive work environments.

To estimate the frequency of antidiabetic prescriptions in type 2 diabetes mellitus (T2DM) in Spain and describe changes in prescription patterns between 2018–2022 and 2023-2024.

Observational study.

Patients from primary care centres newly diagnosed with T2DM in 2018–2022 and 2023–2024.

In each period, the prescription frequency of an antidiabetic medication at the diagnosis of T2DM was calculated and subsequently subdivided into monotherapy and combination therapy. The prescription frequency of the most common antidiabetic drugs was also calculated. Calculations were made for the entire group of subjects and stratified by sex and age (under 60 years and 60 years or older). Comparison of the frequencies between the two periods was performed using the chi-square test.

In 2018–2022 and 2023–2024, 78.4% and 88.9% of patients, respectively, were prescribed an antidiabetic medication. The prescription frequencies for monotherapy and combination therapy were 66.1% and 33.9% in the first period and 57.4% and 42.6% in the second. The prescription frequencies for metformin as monotherapy and combination therapy were 57.4% and 27.8% in the first period and 46.6% and 39.8% in the second. Prescribing metformin with sodium-glucose cotransporter-2 inhibitors (SGLT2i) and/or glucagon-like peptide receptor 1 agonists (GLP1a) was the most frequent combination therapy: 12.8% in 2018–2022 and 29.5% in 2023–2024. With a few exceptions, the prescribing pattern was similar by sex and age. The difference between the prescribing distributions in the two periods is significant.

Antidiabetic medication prescribing at the diagnosis of T2DM was high. Most prescriptions contained metformin. Monotherapy decreased in 2023–2024 compared with 2018–2022, while combination therapy increased due to increased prescriptions of metformin with SGLT2i and/or GLP1a.

Different malaria control measures are deployed simultaneously in endemic settings globally, with varying impacts on malaria burden. In sub-Saharan Africa, which bears the greatest burden of malaria, evidence on the impact of implementing various control interventions on malaria immunity remains unknown. This systematic review seeks to collate evidence on the extent of progression from uncomplicated to severe malaria among populations in sub-Saharan Africa settings receiving concurrent deployment of various malaria control measures.

The review will use a priori criteria contained in the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. An experienced librarian (AAK) will independently search for articles from the following databases: PubMed, Web of Science, Embase, Scopus and Google Scholar. Boolean operators ‘AND’ and ‘OR’ will be used in the article search. Identified articles will be managed using EndNote. Article screening for inclusion and data extraction will be done in duplicate by two reviewers (EJO, and BM). Data extraction tools will be developed and customised in Excel. Data will be analysed using both narrative and quantitative synthesis. The level of heterogeneity between study outcomes will be measured using the I² statistic. Subgroup analysis will be conducted to explore heterogeneity and establish the impact of different control interventions on progression from uncomplicated to severe malaria. A full systematic review and meta-analysis is expected to be ready for dissemination by the end of December 2025.

This study did not involve human participants and so ethical approval was not sought. A full review and a meta-analysis will be published in a peer-reviewed journal and presented at national and international conferences.

CRD 42024619945.

Pelvic organ prolapse (POP) is the descent of one or more pelvic organs through the vaginal canal, including the vagina, uterus, rectum, bladder, cervix, posthysterectomy vaginal cuff, and small or large bowel, which compromises a woman’s physical, mental and social well-being.

This study aimed to explore how women with POP experience their living and its impact on their quality of life (QoL).

This was a qualitative study using interpretive phenomenological analysis, following in-depth structured interviews. Analysis was undertaken to identify superordinate themes relating to how women are living with POP.

3 public hospitals and 3 woredas in Gurage zone, Central Regional State, Ethiopia.

A purposive sample of 12 women who were diagnosed with POP was recruited.

Five core themes with subthemes were identified; general health judgement, POP symptom, life situation related to POP, feeling about POP and limitation in daily life/activity. The majority of respondents expressed concern that the prolapse had negatively impacted their general health and voiced hope that pelvic floor reconstruction would improve their general well-being. The majority of the informants stated that disclosing to others might significantly lower their QoL and that having the condition was extremely embarrassing. The women were most affected by the actual physical symptoms of prolapse (bulge, back pain, heaviness, bowel problems, urinary incontinence) as well as by the impact prolapse has on their sexual function.

Women with POP should be offered psychosocial support, early care and counselling because they have physical, personal, emotional, social and sleep/energy problems. Healthcare providers should take the initiative in educating women regarding prolapse and to make them aware that it is a treatable condition which can improve their QoL.

The development of effective vaccines targeting human papillomavirus (HPV) has significantly contributed to disease prevention, highly relevant in immunosuppressed patients who have higher incidence of HPV-related cancers than their non-immunosuppressed counterparts. However, the acceptance and uptake of the HPV vaccine among immunosuppressed individuals pose unique challenges. Immunocompromised patients’ acceptance of the HPV vaccine is influenced by multifaceted factors, including concerns about safety and effectiveness, interactions with immunosuppressive medications and uncertainties due to their compromised immunity. This systematic review aims to identify the main factors influencing HPV vaccine acceptance among immunosuppressed patients.

A comprehensive search strategy will be executed across databases such as MEDLINE/PubMed, Embase, Scopus, Web of Science, ScienceDirect, Latin American and Caribbean Literature in Health Sciences, Cumulative Index to Nursing and Allied Health Literature and Cochrane Database. The review will encompass the three WHO-endorsed HPV vaccines (quadrivalent, bivalent and nonavalent) and will consider studies related to HPV vaccines and their administration. The scope includes study focusing on immunosuppressed patients who received organ transplants, cancer treatments or are HIV-positive. No temporal restrictions will be applied, and searches will be conducted until December 2025. Observational studies, including retrospective/prospective cohorts, case–control and cross-sectional studies, reporting factors influencing HPV vaccination in immunosuppressed populations will be included. Studies with overlapping patient populations will be excluded. Data extraction will include study details, demographics, vaccine type, risk/protective factors, outcomes and medical history. Validation and cross-verification will ensure data accuracy. Risk of bias will be assessed using ROBINS-I (Risk Of Bias In Non-randomised Studies of Interventions), and GRADE (Grading of Recommendations Assessment, Development and Evaluation) will rate evidence certainty. Meta-analysis, guided by Cochrane and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, will employ fixed/random-effects models, assessing heterogeneity using I² statistics.

This research will analyse previously published data, so ethical approval is not required. The results of the systematic review will be submitted for publication in a peer-reviewed journal.

CRD42023452537.

To assess factors associated with the adoption of the WHO Package of Essential Non-Communicable Diseases (PEN) Protocol 1 at primary healthcare (PHC) facilities in Nepal after healthcare workers received training.

Cross-sectional study.

PHC facilities across various provinces in Nepal.

A total of 180 healthcare workers trained in PEN, recruited from a random selection of 105 basic healthcare facilities.

The adoption of PEN Protocol 1 components: blood pressure measurement, blood glucose screening, 10-year cardiovascular disease (CVD) risk assessment using WHO/International Society of Hypertension risk charts and body mass index (BMI) assessment. Factors associated with protocol adoption were assessed using generalised estimating equations for ORs.

Among participants, 100% reported measuring blood pressure, while 56% measured blood sugar, 28% assessed CVD risk and 27% assessed BMI. The adoption of the CVD risk prediction chart was positively associated with the availability of amlodipine (adjusted OR (aOR) 3.00; 95% CI 1.09 to 8.27). The adoption of BMI assessment was positively associated with access to a stadiometer (aOR 3.23; 95% CI 1.26 to 8.30) and a glucometer (aOR 3.07; 95% CI 1.12 to 8.40), and negatively associated with lack of motivation/inertia of previous practice (aOR 0.60; 95% CI 0.42 to 0.87) and environmental factors such as lack of time and resources (aOR 0.57; 95% CI 0.37 to 0.89). Blood glucose level measurements were positively associated with being at a PHC centre (aOR 7.34; 95% CI 2.79 to 19.3) and the availability of metformin (OR 2.40; 95% CI 1.08 to 5.29).

Adoption of PEN Protocol 1 varied by component and was influenced by resource availability, provider motivation and system barriers. Addressing these factors is key to optimising implementation in low-resource settings.

Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective biomedical intervention for HIV prevention, but its access and utilisation are challenging, especially in high-burden settings such as Kenya. For potential PrEP users, long delays and repeated consultations with several providers are obstacles to both PrEP uptake and continuation. The One-Stop PrEP Care project aims to promote the use of PrEP among clients in the health system and enhance client satisfaction by reducing the waiting time.

We are conducting a 1:1 cluster-randomised trial to evaluate whether One-Stop PrEP Care achieves equivalent or better PrEP outcomes compared with the standard of care model in 12 high-volume HIV clinics in Kisumu County, Kenya. In the One-Stop model, all core PrEP components, including HIV risk evaluation, HIV testing and PrEP dispensing, are provided by one provider in a single consultation room. Programme data from ≥2400 new PrEP clients will be abstracted for 12 months each to obtain primary endpoints of PrEP initiation and continuation. Adherence will be assessed via blood drug level testing. A nested cohort of up to 300 PrEP clients will be enrolled and followed every 3 months to provide in-depth data on individual HIV prevention behaviour, risk perception and how they align PrEP use with perceived risk. We will also evaluate programme costs.

Ethical approval was obtained from the University of Washington Institutional Review Board (IRB) on 8 July 2022 (IRB ID: STUDY00015873) and the Kenya Medical Research Institute Scientific and Ethics Review Unit (SERU) with a letter dated 4 May 2023 (Ref: 4697). Project findings will be shared with stakeholders, including the Ministry of Health, County health officials and participants. Results will be disseminated through manuscripts, policy briefs and health meetings.

Plans for communicating important protocol modifications include timely notifications to all study team members and training on the changes, and updates to relevant stakeholders, including the two IRBs, through protocol amendment submissions.

V. 2.0 dated 21 May 2024.

NCT03194308.

Low-income adults with disabilities experience disproportionately high rates of food insecurity and preventable healthcare utilisation. The Supplemental Nutrition Assistance Program (SNAP) can reduce food insecurity and improve health, but there are accessibility gaps in the SNAP enrolment process. Existing outreach and enrolment assistance programmes have been shown to boost SNAP enrolment, but their health effects are understudied. This study estimates the effects of a SNAP outreach and enrolment assistance programme on health outcomes among low-income adults with disabilities.

The study pragmatically evaluates a programme that provided outreach and SNAP enrolment assistance for low-income households. The study leverages a random process that selected households for one of two types of outreach, including an information-only arm and an information plus enrolment assistance arm, which formed a control group by default. The study will estimate the effect of this programme among low-income adults with disabilities using Medicaid and SNAP administrative data. Study outcomes include emergency department, hospital and long-term nursing home utilisation. SNAP enrolment and benefit amounts are secondary study outcomes and will be tested as a mediating mechanism of action. The study will test effect heterogeneity based on race, ethnicity, age and chronic conditions.

The study, which relies on deidentified data, was determined to be exempt as human subjects research by the Institutional Review Boards at Johns Hopkins Medicine and the Michigan Department of Health and Human Services. The study is being conducted in ongoing consultation with an Advisory Group of experts in food advocacy and disability advocacy. In addition to disseminating findings in peer-reviewed publications, findings will be disseminated to state decision-makers and the community in partnership with an advisory group.