Reporting quality of published reviews of commercial and publicly available mobile health apps (mHealth app reviews): a scoping review protocol

Introduction
Reviews of commercial and publicly available smartphone (mobile) health applications (mHealth app reviews) are being undertaken and published. However, there is variation in the conduct and reporting of mHealth app reviews, with no existing reporting guidelines. Building on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we aim to develop the Consensus for APP Review Reporting Items (CAPPRRI) guidance, to support the conduct and reporting of mHealth app reviews. This scoping review of published mHealth app reviews will explore their alignment, deviation, and modification to the PRISMA 2020 items for systematic reviews and identify a list of possible items to include in CAPPRRI.

Method and analysis
We are following the Joanna Briggs Institute approach and Arksey and O’Malley’s five-step process. Patient and public contributors, mHealth app review, digital health research and evidence synthesis experts, healthcare professionals and a specialist librarian gave feedback on the methods. We will search SCOPUS, CINAHL Plus, AMED, EMBASE, Medline, APA PsycINFO and the ACM Digital Library for articles reporting mHealth app reviews and use a two-step screening process to identify eligible articles. Information on whether the authors have reported, or how they have modified the PRISMA 2020 items in their reporting, will be extracted. Data extraction will also include the article characteristics, protocol and registration information, review question frameworks used, information about the search and screening process, how apps have been evaluated and evidence of stakeholder engagement. This will be analysed using a content synthesis approach and presented using descriptive statistics and summaries. This protocol is registered on OSF (https://osf.io/5ahjx).

Ethics and dissemination
Ethical approval is not required. The findings will be disseminated through peer-reviewed journal publications (shared on our project website and on the EQUATOR Network website where the CAPPRRI guidance has been registered as under development), conference presentations and blog and social media posts in lay language.

Read More

Rationale and design of the Self-TI Study protocol: a cross-sectional human papillomavirus self-testing pilot study among transgender adults in England

Introduction
Persistent infection with high-risk human papillomavirus (HPV) is the causal agent of several cancers including cervical, anal and oropharyngeal cancer. Transgender men and transmasculine non-binary (TMNB) people with a cervix are much less likely to undergo cervical cancer screening than cisgender women. Transgender women and transfeminine non-binary (TWNB) people assigned male at birth may be at increased risk of HPV. Both TMNB and TWNB people face many barriers to HPV testing including medical mistrust due to stigma and discrimination.

Methods and analysis
The Self-TI Study (Self-TI) is a pilot study designed to measure acceptability and feasibility of HPV self-testing among transgender and non-binary people in England. TMNB people aged 25–65 years, with at least 1 year of testosterone, and TWNB people, aged 18 years and over, are eligible to participate. Participants self-collect up to four samples: an oral rinse, a first void urine sample, a vaginal swab (if applicable) and an anal swab. TMNB participants are asked to have an additional clinician-collected cervical swab taken following their routine Cervical Screening Programme sample. TWNB people are asked to take a self-collection kit to perform additional self-collection at home and mail the samples back to the clinic. Acceptability is assessed by a self-administered online survey and feasibility is measured as the proportion of samples returned in the clinic and from home.

Ethics and dissemination
Self-TI received ethical approval from the Research Ethics Committee of Wales 4 and ethical review panel within the Division of Cancer Epidemiology and Genetics at the US National Cancer Institute. Self-TI was coproduced by members of the transgender and non-binary community, who served as authors, collaborators and members of the patient and public involvement (PPI) group. Results of this study will be shared with the community prior to being published in peer-reviewed journals and the PPI group will help to design the results dissemination strategy. The evidence generated from this pilot study could be used to inform a larger, international study of HPV self-testing in the transgender and non-binary community.

Trial registration number
NCT05883111.

Read More

Effects of almond consumption compared with the consumption of traditional isocaloric cereal/pulse-based snacks on glycaemic control and gut health in adults with pre-diabetes in rural India: protocol for a 16-week, parallel-arm, cluster randomised controlled trial

Introduction
Almonds have prebiotic potential to maintain gut health and regulate glycaemia. Western studies have shown their positive effects on preventing non-communicable diseases like diabetes and cardiovascular diseases. However, there is a lack of research involving Asian Indians, who have a higher predisposition to diabetes due to their unique ‘Asian phenotype’. Therefore, this study aims to evaluate the impact of almond supplementation on glycaemic control and gut health in adults with pre-diabetes in rural India through a randomised clinical trial.

Methods and analysis
A parallel cluster randomised controlled trial with 178 participants with pre-diabetes (assigned 1:1) aged 20–50 years, of both genders, with a body mass index of 18.9–25 kg/m2, will be conducted in rural areas of Chikkaballapur, Kolar and Rural Bangalore districts in India. The intervention group will receive 56 g of almonds as mid-morning snacks for 16 weeks, while the control group will receive cereal/pulse-based traditional isocaloric snacks under the closed supervision of the study investigators. The primary outcome of the study is HbA1c measured at the 16th week. The secondary outcomes—anthropometry, clinical and other biochemical parameters—will be measured at 0th, 8th and 16th weeks, and a subgroup of 120 participants will undergo gut health analysis. Glucagon-like peptide 1 analysis will be conducted on 30 participants at 0th and 16th weeks. Statistical analysis will be performed using SPSS for Windows V.27.0, and both intention-to-treat and per-protocol analyses will be conducted.

Ethics and dissemination
Ethics approval was obtained from the Institutional Ethics Committee at Ramaiah Medical College, Bangalore, Karnataka, India (DRPEFP7672021). We will obtain the informed written consent of the participants prior to screening and enrolling them in the study. Results from this trial will be disseminated through publication in peer-reviewed journals and scientific gatherings.

Trial registration number
Clinical Trial Registry of India (CTRI/2023/03/050421).

Read More

Effects of changing criteria on improving interRAI assessment for elder abuse: analysis of a national dataset from Aotearoa New Zealand

Objectives
Globally, one in six older adults in the community will be a victim of abuse (elder abuse; EA). Despite these horrific statistics, EA remains largely undetected and under-reported. Available screening methods and tools fail to accurately identify the phenomenon’s true prevalence. We aimed to test assessment capture rates by altering the criteria for suspicion of EA in the interRAI-HC (International Resident Assessment Instrument–Home Care) in a large national dataset.

Design
We employed secondary analyses of existing data to test a methodology to improve the detection of older adults at risk of EA using the interRAI-HC, which currently underestimates the extent of abuse.

Setting
The interRAI is a suite of clinical assessment instruments. In Aotearoa New Zealand, interRAI is mandatory in aged residential care and home and community services for older people living in the community. They are designed to show the assessor opportunities for improvement and any risks to the person’s health.

Outcome measure
Capture rates of individuals at risk of EA when the interRAI Abuse-Clinical Assessment Protocol (A-CAP) is changed to include the unable to determine abuse (UDA) group shown in a pilot study to increase capture rates of individuals at risk of EA.

Results
Analysis of 9 years of interRAI-HC data (July 2013–June 2022) was undertaken, encompassing 186 713 individual assessments consisting of 108 992 women (58.4%) and 77 469 men (41.5%). The mean age was 82.1 years (range: 65–109); the majority 161 378 were European New Zealanders (86.4%) and the most common minority ethnicity was Māori (6.1%). Those at high risk of abuse (A-CAP) tended to be male (2402; 51.0%), were 79.2 years old on average (range 65–105), with 49.6% (2335) living alone, 39.4% (1858) suffering from depression and a majority were assessed as not having independent decision making (2942; 62.5%). In comparison, the UDA group showed similar characteristics to the A-CAP group on some measures. They were slightly younger than the general sample, with a mean age 80.1 years (range 65–107), they had higher rates of depression (2123; 33.5%) compared with the general sample (25 936; 14.8%) and a majority were assessed as not having independent decision-making (3855; 60.9%). The UDA group is distinct from the general sample and the UDA group broadly has similar but less extreme characteristics to the A-CAP group. Through altering the criteria for suspicion of EA, capture rates of at-risk individuals could be more than doubled from 2.5% to 5.9%.

Conclusions
We propose that via adapting the interRAI-HC criteria to include the UDA category, the identification of older adults at risk of EA could be substantially improved, facilitating enhanced protection of this vulnerable population.

Read More

Just-in-time adaptive interventions for adolescent and young adult health and well-being: protocol for a systematic review

Introduction
Health behaviours such as exercise and diet strongly influence well-being and disease risk, providing the opportunity for interventions tailored to diverse individual contexts. Precise behaviour interventions are critical during adolescence and young adulthood (ages 10–25), a formative period shaping lifelong well-being. We will conduct a systematic review of just-in-time adaptive interventions (JITAIs) for health behaviour and well-being in adolescents and young adults (AYAs). A JITAI is an emerging digital health design that provides precise health support by monitoring and adjusting to individual, specific and evolving contexts in real time. Despite demonstrated potential, no published reviews have explored how JITAIs can dynamically adapt to intersectional health factors of diverse AYAs. We will identify the JITAIs’ distal and proximal outcomes and their tailoring mechanisms, and report their effectiveness. We will also explore studies’ considerations of health equity. This will form a comprehensive assessment of JITAIs and their role in promoting health behaviours of AYAs. We will integrate evidence to guide the development and implementation of precise, effective and equitable digital health interventions for AYAs.

Methods and analysis
In adherence to Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines, we will conduct a systematic search across multiple databases, including CENTRAL, MEDLINE and WHO Global Index Medicus. We will include peer-reviewed studies on JITAIs targeting health of AYAs in multiple languages. Two independent reviewers will conduct screening and data extraction of study and participant characteristics, JITAI designs, health outcome measures and equity considerations. We will provide a narrative synthesis of findings and, if data allows, conduct a meta-analysis.

Ethics and dissemination
As we will not collect primary data, we do not require ethical approval. We will disseminate the review findings through peer-reviewed journal publication, conferences and stakeholder meetings to inform participatory research.

PROSPERO registration number
CRD42023473117.

Read More

Cross-sectional study to investigate the seroprevalence and risk factors of Toxoplasma gondii among women attending the antenatal clinic in Namwala, Zambia

Background
Toxoplasmosis is a zoonotic parasitic disease caused by Toxoplasma gondii (T. gondii). It has a wide host range and is capable of vertical transmission in pregnant women, which may lead to undesirable pregnancy outcomes such as congenital malformations, miscarriage, premature birth and stillbirth. This study investigated the seroprevalence of T. gondii infection among pregnant women attending the antenatal clinic at Namwala District Hospital in Southern Zambia.

Methods
This was a cross-sectional study where blood was collected, and the serum was tested for Toxoplasma IgG and IgM. A questionnaire was administered to participants on demographic characteristics and risk factors. Data were entered in Microsoft Excel and exported to STATA version 14 for analysis.

Results
A total of 401 women were enrolled in the study from 3 March to 5 August 2021. The seroprevalence of Toxoplasma IgG was 4.2% (n=17), while the seroprevalence of Toxoplasma IgM was 0.7% (n=3). The median age was 27 (IQR: 24–30) years, and a larger proportion had primary-level education (n=223, 55.6%). The majority (81.6%) of the women were married. None of the risk factors investigated in this study were significant for T. gondii infection.

Conclusion
There was a low seroprevalence of T. gondii infection among pregnant women in the Namwala district of Southern Province, Zambia, and regular screening may not be warranted in this population. Continued research on toxoplasmosis is recommended to understand its epidemiology across Zambia.

Read More

Integrating evidence and causal mapping of help-seeking behaviour of migrant women with postpartum depression in Shanghai, China: a scoping review protocol

Introduction
The estimated prevalence of postpartum depression (PPD) worldwide, in China, and Shanghai is 17.2%, 18.0% and 23.2%, respectively. In 2021, Shanghai housed a population of 3.2 million childbearing-age migrant women, most of whom migrated to the city with their husbands for economic reasons. There is a general lack of help-seeking behaviour for mental disorders in China due to the perceived risk of social stigmatisation. In Shanghai, 70% of women did not seek professional help for perinatal mental health problems. We aim to gather information from multiple perspectives, such as the migrant women with PPD and perinatal depression (PND), their caregivers, health service providers and communities, to understand the help-seeking behaviour of postpartum migrant women with PPD or PND in China.

Methods and analysis
The Preferred Reporting Items for Systematic Reviews and Meta-Analyses framework for Scoping Reviews will guide this review. A bilingual research librarian developed a comprehensive search strategy to retrieve published and unpublished English and Chinese studies involving factors influencing women’s PPD or PND help-seeking behaviour in China. This literature includes perceptions, views, patterns, acceptance and refusal, tendencies, probability, service accessibility and utilisation, and facts. We will search PubMed, Embase, Web of Science and CINAHL for English literature and CINKI for Chinese literature. Backward and forward snowball approaches will be used to identify additional relevant papers from the reference lists of selected papers. Two independent reviewers will screen the title and abstract and review the full text of selected papers to identify eligible articles for data extraction. We will build a Microsoft Access database to record the extracted data. The results will be presented in tables and a causal map to demonstrate the relationships between extracted variables and help-seeking behaviours for PPD and PND. A conceptual simulation model will be formulated based on the information from the literature to validate the logic of the relationships between variables, identify knowledge gaps and gain insights into potential intervention approaches. Experts and stakeholders will be invited to critique and comment on the results during group model building (GMB) workshops in Shanghai. These comments will be essential to validate the findings, receive feedback and obtain additional insights.

Ethics and dissemination
The literature review component of our study does not require ethical approval because the information and data collected will be obtained from publicly available sources and will not involve human subjects. Our collaborating research partner, International Peach Maternal Child Hospital, obtained the IRB approval (GKLW-A-2023-020-01) for screening and enrolling participants in GMB workshops. Stanford University received IRB approval under protocol number 67 419. The full review will be presented at a relevant conference and submitted to a peer-reviewed scientific journal for publication to report findings.

Read More

Is Screening for Primary Aldosteronism Always the Best Option?

To the Editor Patients with hypertension and primary aldosteronism (PA) face a grim prognosis in the absence of specific therapy; they must be promptly identified and managed. Charoensri et al reported on an enhanced effective screening rate for this population, reaching up to 9.9%, through an artificial intelligence−based best practice advisories system that identifies patients who are at high-risk for PA for clinicians. Although this is an improvement compared with the commonly reported 2% to 4% rate, screening remained infrequent even in this study context, with 90.1% of patients who were identified as being at high risk not undergoing screening. Some may perceive this as a failure, but we believe a critical outcome is absent, hindering a proper evaluation of the intervention’s effectiveness.

Read More

Is Screening for Primary Aldosteronism Always the Best Option?—Reply

In Reply We appreciate the perspective from Boulestreau and Couffinhal on our recent initiative to enhance screening for primary aldosteronism (PA) by leveraging electronic health records capabilities. We designed and implemented an advisory that identifies PA screening candidates and assists clinicians with test ordering and interpretation. Boulestreau and Couffinhal suggest empirical use of mineralocorticoid receptor antagonists (MRA) to treat patients with possible PA as a more pragmatic alternative to PA screening.

Read More

The Interval for Screening Colonoscopy—Is 15 the New 10?

Most colorectal cancers (CRCs) develop via the adenoma-carcinoma sequence, a stepwise process characterized by mutations in healthy tissue that accumulate in the progression from adenomatous polyps to cancer. First coined the polyp-cancer sequence nearly a century ago, it is widely believed that the contemporary concept was first used by Jackman and Mayo in 1951. Even before more modern sequencing technology facilitated the elucidation of the underlying molecular mechanisms, it was well understood that this process is typically slow, generally taking approximately 10 years. This time frame is the empirical basis for most current colorectal cancer screening guidelines that endorse a 10-year interval after a colonoscopy with no abnormal findings.

Read More

Implementation of First-trimester Screening and Prevention of Preeclampsia: a Stepped Wedge Cluster-randomized Trial in Asia

Circulation, Ahead of Print. Background: This trial aimed to assess the efficacy, acceptability and safety of a first-trimester screen-and-prevent strategy for preterm preeclampsia (PE) in Asia.Methods: Between 1stAugust 2019 and 28thFebruary 2022, this multicenter stepped wedge cluster randomized trial included maternity/diagnostic units from ten regions in Asia. The trial started with a period where all recruiting centers provided routine antenatal care without study-related intervention. At regular six-week intervals, one cluster was randomized to transit from non-intervention phase to intervention phase. In the intervention phase, women underwent first-trimester screening for preterm PE using a Bayes theorem-based triple-test. High-risk women, with adjusted risk for preterm PE ≥ 1 in 100, received low-dose aspirin from

Read More