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Genetic, lifestyle and environmental influences on health: a Finnish biobank recall study protocol (BioRecall)

Por: Sillanpää · E. · Föhr · T. · Kurtti · E. · Aittola · K. · Mäkelä · J. · Southerington · T. · Lakka · T. A. · Jokela · T. · Ahtiainen · M. · Laakkonen · E. · Rantakokko · M. · Ravi · S.
Introduction

Non-communicable diseases are the leading causes of premature mortality worldwide. Both genetic predispositions and environmental exposures affect disease risk. While biobanks have increased understanding of genetic predictors of these diseases, environmental influences are expected to have a greater impact on disease development. Individuals also create their own environments and lifestyles based on genetically regulated preferences, leading to gene–environment interactions that require large datasets to study. Finnish biobanks typically lack sufficient lifestyle and environmental data, which limits their use. We present a protocol for a biobank-recall study (BioRecall) to collect data on lifestyle and environmental exposures and combine these findings with genotypes, biological samples and clinical outcomes.

Methods and analysis

All previously genotyped donors from the Central Finland Biobank who have been diagnosed with type 2 diabetes and have consented to recall will be invited to participate in the pilot study. The preliminary feasibility assessment reveals that there are 1580 suitable candidates. Participants will complete an electronic questionnaire on a secure online platform. The questionnaire includes validated questions on lifestyles, anthropometrics, weight loss history, health, symptoms, work characteristics, emotional states and residential environments. Postcode information will facilitate the addition of spatial environmental data. Genotype and related clinical data will be provided in the study in accordance with the Finnish Biobank Act and combined with questionnaire data.

Ethics and dissemination

The Human Sciences Ethics Committee of the University of Jyväskylä delivered a favourable statement regarding the study protocol (1671/13.00.04.00/2023). Central Finland Biobank approved the research plan (no: BB24-0333-A01). The data collected will be returned to the Central Finland Biobank for research purposes with the participants’ consent. Permission for data usage can then be applied through standard protocols of the Fingenious service (https://site.fingenious.fi/en/). If successful, the study will be expanded to other donors and Finnish biobanks.

Social support and its associated factors among people on drug-resistant tuberculosis treatment in three selected hospitals in Ethiopia: a cross-sectional study design

Por: Bedada · T. D. · Bejiga · B. · Gemtesa · D. F. · Gutema · G. · Abebe · S. · Tola · H.
Objective

Social support is an important factor for psychosocial well-being and motivation to follow the treatment strictly in people with drug-resistant tuberculosis (DR-TB). Thus, this study aimed to determine the availability of social support and its association factors in people with DR-TB in selected hospitals in Ethiopia.

Design

A cross-sectional study was conducted in Addis Ababa (at Saint Peter and ALERT hospitals) and Bishoftu Hospital in Ethiopia. The study involved 130 people with DR-TB from January to May 2023.

Participants

All adult people on DR-TB treatment for at least 2 months were enrolled consecutively from the registration book. A structured questionnaire was used to collect data. Data were entered to Open Data Kit and analysed with SPSS V.22. Descriptive statistics were used to describe the characteristics of the participants. A linear regression model was used to assess factors associated with social support.

Main outcome

Availability of social support from different sources.

Results

The overall proportion of availability of social support obtained from different sources was 97.7% with 95% CI of (93.1% to 99.5%). Sex (β=0.61, 95% CI (0.28 to 0.94); p

Conclusions

A considerable proportion of people with DR-TB were obtaining social support from different sources. Interventions targeted female sex, single marital status and perceived social stigma are required to enhance social support conditions in people with DR-TB.

Barriers and facilitators to performing benign paroxysmal positional vertigo manoeuvres among primary care physicians in Barcelona: a qualitative study

Objective

To explore the barriers and facilitators in adherence to the guidelines in the management of benign paroxysmal positional vertigo from the perspective of primary care physicians.

Design

Qualitative study using focus groups.

Setting

L’Hospitalet del Llobregat (Barcelona), Spain.

Study design

Qualitative study using focus groups. Structured 90 min focus groups were conducted until data saturation was reached. Each session included a moderator and an observer from the research team. Sessions were transcribed and thematically analysed by three independent researchers.

Participants

Purposeful sampling was used to form four groups of 4–10 participants, selected by sex, age, years of experience and primary care team (PCT). Participants were recruited between January and February 2023.

Results

A total of 34 family physicians belonging to four PCTs participated in the study. The main barriers identified were a lack of time, negative initial experiences, a fear of harming patients (especially older adults), difficulty in nystagmus visualisation and challenges in managing patient expectations, as many preferred medication over physical manoeuvres. Facilitators included potential time savings from effective early management, the value of initial practical training with periodic refreshers, access to expert consultants for case discussions and the availability of digital tools, such as tutorials, videos and aids for nystagmus interpretation.

Conclusion

Health systems should invest in protected time for history-taking and physical examination, and in regular, updated training for primary care professionals. This could improve vertigo management and reduce unnecessary investigations and medications, ultimately benefiting both patients and the healthcare system.

Protocol for a modified Delphi study of ethical oversight of data science health research (DSHR)

Introduction

The use of data science for health research produces complex ethical, legal and social challenges that traditional ethical oversight mechanisms struggle to address. In Nigeria, the current ethical guidelines were not designed for these challenges which include pervasive data environments, consent for secondary data use, algorithmic decision-making and bias, privacy risks, involvement of commercial entities, data colonisation, inequitable benefit-sharing and commercial data holdings. To address these gaps, we developed a draft guideline incorporating principles like trust, veracity, global justice and alternative ethical approval mechanisms. Here, we describe the protocol for a study aimed at validating the guideline through stakeholder consensus on the content, feasibility and acceptability of this subcode for national implementation.

Methods and analysis

We describe the use of a modified e-Delphi approach to iteratively synthesize expert opinions about ethical oversight for data science health research (DSHR) led by a multidisciplinary working group from the Bridging Gaps in the ELSI of Data Science Health Research in Nigeria (BridgELSI) team. We will invite 65 experts, including health researchers, ethics committee members, data scientists, health policymakers, funders and key opinion leaders in Nigeria to participate. Participants will rate 13 core principles, including global justice, algorithmic bias, data governance and related governance provisions on importance, desirability for inclusion in national guidelines, feasibility and confidence in implementation, using 5-point Likert scales, with optional free-text comments. We will summarise responses using descriptive statistics, assess consensus and polarity using pre-specified thresholds for the mean and IQR, and iteratively refine statements between rounds using qualitative content analysis of comments.

Ethics and dissemination

Ethical approval was obtained from the Nigerian National Health Research Ethics Committee and the University of Maryland IRB, and participants will provide informed consent. Results will be shared with the expert panel and national regulators and disseminated via publications and conferences.

Long-term effects of psychotherapy in children and adolescents: protocol for database development and a systematic review in the LaKiJu META project

Por: Schäfer · S. K. · Burmeister · C. F. · Lottermoser · E. · Schäfer · C. G. · Cascant Ortolano · L. · Stoffers-Winterling · J. · Flasinksi · T. · Equit · M. · Schneider · S. · Lieb · K. · de Haan · A.
Introduction

Approximately one in every six children and adolescents is affected by mental disorders, which impose significant costs on patients, their families and societies. Psychotherapy is the first-line treatment for many of these disorders, and systematic reviews of post-intervention effects show small to moderate favourable outcomes compared with control groups. However, the long-term effects of psychotherapy remain less well understood.

Methods and analysis

The LaKiJu META project aims to address this gap by developing an open-access database, which will subsequently be used for data synthesis. This database will be established through literature searches in nine databases for (cluster) randomised controlled trials (RCTs) investigating the long-term effects (≥6 months) of any type of psychotherapy in school-aged children and adolescents (ages 6;00 to 17;11 years) with mental disorders. Outcomes will be prioritised based on their relevance to patients, caregivers and clinicians and will encompass a broad range of measures, including symptom changes, response rates and reliable changes. Syntheses will use multilevel meta-analyses to compare intervention and control groups at follow-up assessments, across both transdiagnostic and disorder-specific symptom outcomes. In secondary analyses, we will examine changes within intervention groups over time. Moderator analyses will focus on the effects of study-, intervention- and patient-level characteristics.

Ethics and dissemination

Ethical approval for public involvement was obtained from the ethics committee of the Faculty of Psychology of the Ruhr University Bochum. For dissemination, we will employ tailored strategies to reach researchers, clinicians, patients and their caregivers, with all groups involved in the development of dissemination plans.

PROSPERO registration number

CRD420251003208 (preregistered on 10 March 2025).

Changes in prescription patterns of antidiabetic medication in patients newly diagnosed with type 2 diabetes in Spain: an observational study

Por: Cea-Soriano · L. · Moreno · A. · Calonge · M. · Rivas · A. · Pulido-Manzanero · J. · Colchero · M. C. · Artola · S. · Serrano · R. · Franch-Nadal · J. · Regidor · E. · the PRECOZIN Study Group · Adan · Almanzar · Alonso · Alonso · Alonso · Alvarez · Alvarez · Amoros · Araujo · Arbide
Objective

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.

Design

Observational study.

Participants

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

Primary and secondary outcomes

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.

Results

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.

Conclusion

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.

Mental health disorders among people living with HIV in sub-Saharan Africa: a scoping review protocol

Por: Adedeji · W. A. · Ishola · A. G. · Elugbadebo · O. · Oladepo · O. M. · Mudzviti · T. · Kaiyo-Utete · M. · Willis · N. · Adebayo · D. A. · Mtisi · T. J. · Chokuona · K. F. V. · Ma · Q. · Cha · R. · Hutson · A. · Charurat · M. E. · Yusuf · O. B. · Maponga · C. · Fehintola · F. A. · Gureje
Background

The mental health of people living with HIV (PLWH) is a growing concern globally, particularly in sub-Saharan Africa (SSA), where there is limited access to mental healthcare, with evidence showing high levels of depression, anxiety and neurocognitive disorders among this population. While Mental Health Disorders (MHDs) can impede HIV care and promote adverse health outcomes, there is limited literature on MHDs among PLWH. This scoping review will explore the existing literature on the burden and factors associated with MHDs among adults living with HIV in SSA.

Methods and analysis

Arksey and O’Malley’s methodological framework will guide the search of this scoping review. Relevant original research articles published in English from 1 January 2000 to 31 May 2025 on MHDs among PLWH in SSA will be identified through searches in the African Index Medicus, African Journal Online, PubMed and Embase databases. Four independent reviewers, working in pairs (one reviewer and one verifier), will screen the titles, abstracts and later the full texts, adopting the population, concept and context framework. Other coauthors will serve as tiebreakers whenever there is disagreement on the eligibility. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews flowchart will be presented. We will perform a narrative synthesis to report our findings.

Ethics and dissemination

This scoping review protocol does not require ethical approval, as it relies solely on publicly available existing data and does not involve human participants. We will disseminate the findings from this review through peer-reviewed publications and presentations at local and international conferences.

Trial registration

The protocol was registered in the Open Science Framework (https://osf.io/8ymqu).

ProVag: the effect of oral probiotics on the vaginal microbiota composition in women receiving medical assisted reproduction in a Dutch fertility clinic - protocol of a randomised, placebo-controlled, double-blind study

Por: van Haren · A. · Morre · S. A. · Stolaki · M. · de Jonge · J. · Stevens Brentjens · L. · van Golde · R.
Introduction

Differences in the profile of the vaginal microbiota (VMB) have been associated with pregnancy rates after medical assisted reproduction (MAR) such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI). Monitoring the VMB profile of IVF patients creates an opportunity to identify the best window for IVF treatment and embryo transfer. The ReceptIVFity test is a predictive test that assesses the chances of becoming pregnant in women undergoing IVF treatment based on the VMB composition. A VMB profile dominated by beneficial strains, most notably Lactobacillus species, is associated with increased pregnancy chances. However, to date, limited evidence is available on the effect of active modification strategies to facilitate the modulation of the VMB profile to help restore a VMB dominated by Lactobacillus species.

Methods and analysis

This is a randomised, placebo-controlled, double-blind intervention study. The study will involve 1:1 randomisation to one of the two arms: oral probiotic or placebo. Vaginal and rectal swabs will be collected at intake and 4, 6 and 8 weeks after the start of the treatment. Our objective is to determine if oral probiotic treatment improves the VMB profile of IVF patients from a low to a medium/high ReceptIVFity score, compared with placebo treatment. Secondary outcomes are: the potential of the bacterial strains in the oral probiotic to be detected in the vaginal tract and/or in the gut, and if the treatment leads to an increased ongoing pregnancy rate after IVF.

Ethics and dissemination

Ethical approval was obtained by the local medical ethical review committee at the Maastricht University Medical Centre. Findings from this study will be published in a peer-reviewed scientific journal and presented at one or more scientific conferences.

Trial registration number

CCMO NL81210.068.22, registered 25 September 2023.

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