Benefit–risk assessment (BRA) is used in multiple phases along the health technology’s life-cycle to evaluate the balance between the benefits and risks, as it is fundamental to all stakeholders. BRA and its methodological approaches have been applied primarily in the context of regulatory agencies. However, BRA’s application and extent in the context of health technology assessment (HTA) bodies remain less clear. Our goal is to perform a scoping review to identify and map methodological guidelines and publications on methods of BRA. This will be done considering the different phases of the life-cycle of health technologies to underline both the depth and extent of research concerning BRA, especially in the context of HTA.

This scoping review protocol was developed following the framework proposed by Arksey and O’Malley, and the updated guidelines by the Joanna Briggs Institute. We will include methodological publications that provide recommendations or guidelines on methods for BRA. We will conduct electronic searches on Medline (PubMed) and EMBASE (Ovid) databases; manual searches on the main websites of HTA bodies and drug regulatory organisations; and contact experts in the field. Systematic extraction forms will be used to screen and assess the identified publications by independent assessors. We will provide a qualitative synthesis using descriptive statistics and visual tools. Results will be summarised in systematic evidence tables and comparative evidence scoping charts.

This review will use data publicly available and does not require ethics approval. The results of this scoping review will contribute to scientific knowledge and act as a basis for methodologists, guideline developers and researchers for the development of BRA to inform regulatory decisions, reimbursement and coverage decision making. The results will be disseminated through peer-reviewed articles, conferences, policy briefs and workshops.

Open Science Framework (https://doi.org/10.17605/OSF.IO/69T3V).

The study was conducted to assess potential drug–drug interactions (PDDIs) and its determinants among patients with cancer receiving chemotherapy.

An institutional-based cross-sectional study was used. This study was conducted from 1 June 2021 to 15 December 2021, in Northwest Ethiopia oncology centres.

All eligible patients with cancer received a combination of chemotherapy.

The prevalence and severity of PDDIs were evaluated using three drug interaction databases. Characteristics of participants were presented, arranged and summarised using descriptive statistics. The predictors and outcome variables were examined using logistic regression. The cut-off point was a p value of 0.05.

Of 422 patients included in the study, 304 patients were exposed to at least one PDDI with a prevalence of 72.1% (95 % CI: 68% to 76%) using three drug interaction databases. There were varied reports of the severity of PDDI among databases, but the test agreement using the kappa index was 0.57 (95% CI: 0.52 to 0.62, p=0.0001) which is interpreted as a moderate agreement among three databases. Patients aged ≥50 years old had the risk to be exposed to PDDI by odds of 3.1 times (adjusted OR (AOR)=3.1, 95% CI (1.8 to 5.3); p=0.001) as compared with patients

The main finding of this study is the high prevalence of PDDI, signifying the need for strict patient monitoring for PDDIs among patients with cancer receiving chemotherapy. We suggest the use of at least three drug databases for quality screening. Patients with an age ≥50 years old, polypharmacy and comorbidity were significantly associated with PDDIs. The establishment of oncology clinical pharmacists and computerised reminder mechanisms for PDDIs through drug utilisation review is suggested.

Worldwide, the prevalence of degenerative diseases such as dementia and mild cognitive impairment (MCI) is increasing with population ageing and increasing life expectancy. Both conditions share modifiable risk factors. Physical inactivity is one of these modifiable risk factors, and research points to the protective effect of physical activity on the incidence of dementia and MCI. However, this association tends to change according to type, intensity, frequency, duration and volume of physical activity. Furthermore, it remains unclear which of these characteristics offers the greatest protective effect. Therefore, this study aims to evaluate the impacts of different types, intensities, frequencies, duration and volume of physical activity on dementia and cognitive decline in older adults.

The search will be carried out from October 2023, using the following databases: PubMed, Embase, Scopus, CINAHL and Web of Science. Cohort studies with a follow-up time of 1 year or longer that have investigated the incidence of dementia and/or MCI in older adults exposed to physical activity will be included. There will be no limitations on the date of publication of the studies. Studies published in English, Spanish or Portuguese will be analysed. Two researchers will independently screen the articles and extract the data. Any discrepancies will be resolved by a third reviewer. Association measures will be quantified, including OR, HR, relative risk and incidence ratio, with a 95% CI. If the data allow, a meta-analysis will be performed. To assess the methodological quality of the selected studies, the Grading of Recommendations, Assessment, Development and Evaluations instrument, and the Downs and Black instrument to assess the risk of bias, will be used.

Ethical approval is not required. The results will be submitted for publication in a peer-reviewed journal.

CRD42023400411.

Our aim was to investigate the association between early environmental factors and the development of coeliac disease (CeD) in adolescents, recruited from a cohort nested in the Danish National Birth Cohort (DNBC).

The study was designed as a prospective cohort study, nested in DNBC

The Glutenfunen cohort comprises 1266 participants, nested in DNBC. All participants were screened for CeD, and in total, 28 cases of biopsy proven CeD were identified. Data about breastfeeding, timing of introduction to solid food in infancy, use of antibiotics, infections and symptoms were parentally reported prospectively at 6 months and 18 months, respectively. We estimated ORs and 95% CIs of CeD in adolescents using logistic regression analysis.

Viral croup reported at 18 months of age was associated with CeD in adolescents with an OR of 3.2 (95% CI: 1.2 to 8.7). Furthermore, otitis media also reported at 18 months of age was linked with CeD with an OR of 3.2 (95% CI: 1.5 to 7.3). We were not able to find any statistical associations between CeD and breastfeeding, frequency of infections, parentally reported use of antibiotic and timing of solid foods.

In this study, we present an overview of the relationship between early environmental factors and occurrence of CeD in adolescents. Our findings, despite limitations due to a limited number of cases of CeD, suggest a role of viral infections in the pathogenesis of CeD

To explore patients’ experiences accessing healthcare for obesity and their perceived behaviour changes following the care.

Using a descriptive qualitative research approach informed by Levesque’s framework of access to healthcare, we conducted phone interviews in the Malaysian language, which were audio-recorded and transcribed verbatim. Data were analysed inductively using a reflexive thematic analysis approach.

Primary care clinics in five states in Peninsular Malaysia.

Adult patients with obesity receiving face-to-face care for obesity from healthcare providers in Peninsular Malaysia.

We interviewed 22 participants aged 24–62, with the majority being female (77%), Malay (95%), married (73%) and with tertiary education (82%). Most participants attended obesity management services at public primary care clinics. We identified five themes: (1) moving from perceiving the need to seeking obesity care is a non-linear process for patients, (2) providers’ words can inspire patients to change, (3) patients’ needs and preferences are not adequately addressed in current obesity care, (4) over-focusing on weight by patients and healthcare providers can lead to self-blame and loss of hope for patients and (5) obesity healthcare can have consequences beyond weight loss.

Patients lack the self-regulatory skills to continue their lifestyle changes and struggle with self-blame and hopelessness. Over-focusing on weight by patients and obesity healthcare increase patients’ self-stigmatisation. While provider-initiated weight discussions and engaging and personalised consultation provide the initial step towards weight management, obesity healthcare could be enhanced by behavioural support and patient education on the complexity of obesity. Further considerations could be given to shifting from a weight-centric to a more holistic health-centred approach in obesity healthcare.

The aim of this study was to assess the health-related quality of life (HRQoL) and associated factors among patients with schizophrenia at comprehensive specialised hospitals in Northwest Ethiopia.

A cross-sectional study was conducted among 422 patients with schizophrenia who were followed at comprehensive specialised hospitals in Northwest Ethiopia from 1 June to 30 August 2022.

All adult patients with schizophrenia who had regular follow-up in the outpatient departments of the selected hospitals were study participants.

The main outcome of this study was HRQoL which was measured using the WHO Quality of Life Scale–Bref Version. Data entry and analysis were done using Epi-data version 4.6.1 and SPSS version 24, respectively. Linear regression was used to assess the association between quality of life and independent variables. Variables with a p value

The mean score of the overall Quality of Life Scale–Brief Version was 22.42±3.60. No formal education (ß=–1.53; 95% CI: –2.80 to –0.27), duration of treatment (ß = –3.08; 95% CI: –4.71 to –1.45), comorbidity (ß=–1.14; 95% CI: –1.99 to –0.29), substance use (ß=–0.89; 95% CI: –1.56 to –0.23), extrapyramidal side effects (ß=–2.02; 95% CI: –2.90 to –1.14), non-adherence (ß=–0.83; 95% CI: –1.44 to –0.23), and antipsychotic polypharmacy (ß=–1.77; CI: –2.57 to –0.96) were negatively associated with quality of life.

In this study, the social domain was recorded as having the lowest mean score, which may indicate that patients with schizophrenia could need better psychosocial support. Patients with a longer duration of treatment, who had comorbid illnesses, were substance users, developed EPS, were non-adherent to medications and were on antipsychotic polypharmacy, needs critical follow-up to improve HRQoL.