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AnteayerBMJ Open

Cohort profile: The Scottish SHARE Mental Health (SHARE-MH) cohort - linkable survey, genetic and routinely collected data for mental health research

Por: Iveson · M. H. · Ball · E. L. · Doherty · J. · Pugh · C. · Vashishta · S. · Palmer · C. N. A. · McIntosh · A.
Purpose

The SHARE Mental Health (SHARE-MH) cohort was established to address the paucity of clinical and genetic data available for mental health research. The cohort brings together detailed mental health questionnaire responses, routinely collected electronic health data and genetic data to provide researchers with an unprecedented linkable dataset. This combination of data sources allows researchers to track mental health longitudinally, across multiple settings. It will be of interest to researchers investigating the genetic and environmental determinants of mental health, the experiences of those interacting with healthcare services, and the overlap between self-reported and clinically derived mental health outcomes.

Participants

The cohort consists of individuals sampled from the Scottish Health Research Register (SHARE). To register for SHARE, individuals had to be over the age of 16 years and living in Scotland. Cohort participants were recruited by email and invited to take part in an online mental health survey. When signing up for SHARE, participants also provided written consent to the use of their electronic health records and genetic data—derived from spare blood samples—for research purposes.

Findings to date

From 5 February 2021 to 27 November 2021, 9829 individuals completed a survey of various mental health topics, capturing information on symptoms, diagnoses, impact and treatment. Survey responses have been made linkable to electronic health records and genetic data using a single patient identifier. Linked data have been used to describe the cohort in terms of their demographics, self-reported mental health, inpatient and outpatient hospitalisations and dispensed prescriptions.

Future plans

The cohort will be improved through linkage to a broader variety of routinely collected data and to increasing amounts of genetic data obtained through blood sample diversion. We see the SHARE-MH cohort being used to drive forward novel areas of mental health research and to contribute to global efforts in psychiatric genetics.

Interventions to promote the health and well-being of children under 5s experiencing homelessness in high-income countries: a scoping review

Por: Tu · Y. · Sarkar · K. · Svirydzenka · N. · Palfreyman · Z. · Parry · Y. K. · Ankers · M. · Parikh · P. · Raghavan · R. · Lakhanpaul · M.
Objectives

Homelessness among families with children under 5 residing in temporary accommodation is a growing global concern, especially in high-income countries (HICs). Despite significant impacts on health and development, these ‘invisible’ children often fall through the gaps in policy and services. The study’s primary objective is to map the content and delivery methods of culturally sensitive interventions for children under 5 experiencing homelessness in HICs.

Design

A scoping review guided by the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews checklist.

Data sources

Databases include PubMed, Medline, SCOPUS, The Cochrane Library and Google Scholar were searched up to 24 March 2022.

Eligibility criteria

This scoping review includes studies that describe, measure or evaluate intervention strategies aimed at improving child health programmes, specifically those yielding positive outcomes in key areas like feeding, nutrition, care practices and parenting.

Data extraction and synthesis

Articles were selected and evaluated by two independent reviewers, with a dispute resolution system involving a third reviewer for contested selections. The methodological quality of the studies was assessed using various tools including the Risk of Bias (RoB) tool, Cochrane RoB V.2.0, the Risk of Bias Assessment Tool for Non-randomized Studies (RoBANS) and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE), each selected according to the type of article.

Results

The database search yielded 951 results. After deduplication, abstract screening and full review, 13 articles met the inclusion criteria. Two predominant categories of intervention delivery methods were identified in this research: group-based interventions (educational sessions) and individual-based interventions (home visits).

Conclusion

This review highlights effective interventions for promoting the health and well-being of children under 5 experiencing homelessness, including educational sessions and home visits. Research has supported the importance of home visiting to be instrumental in breaking down language, cultural and health literacy barriers.

Integrating 4 methods to evaluate physical function in patients with cancer (In4M): protocol for a prospective cohort study

Por: Thanarajasingam · G. · Kluetz · P. · Bhatnagar · V. · Brown · A. · Cathcart-Rake · E. · Diamond · M. · Faust · L. · Fiero · M. H. · Huntington · S. · Jeffery · M. M. · Jones · L. · Noble · B. · Paludo · J. · Powers · B. · Ross · J. S. · Ritchie · J. D. · Ruddy · K. · Schellhorn · S. · Tarv
Introduction

Accurate, patient-centred evaluation of physical function in patients with cancer can provide important information on the functional impacts experienced by patients both from the disease and its treatment. Increasingly, digital health technology is facilitating and providing new ways to measure symptoms and function. There is a need to characterise the longitudinal measurement characteristics of physical function assessments, including clinician-reported outcome, patient-reported ported outcome (PRO), performance outcome tests and wearable data, to inform regulatory and clinical decision-making in cancer clinical trials and oncology practice.

Methods and analysis

In this prospective study, we are enrolling 200 English-speaking and/or Spanish-speaking patients with breast cancer or lymphoma seen at Mayo Clinic or Yale University who will receive intravenous cytotoxic chemotherapy. Physical function assessments will be obtained longitudinally using multiple assessment modalities. Participants will be followed for 9 months using a patient-centred health data aggregating platform that consolidates study questionnaires, electronic health record data, and activity and sleep data from a wearable sensor. Data analysis will focus on understanding variability, sensitivity and meaningful changes across the included physical function assessments and evaluating their relationship to key clinical outcomes. Additionally, the feasibility of multimodal physical function data collection in real-world patients with breast cancer or lymphoma will be assessed, as will patient impressions of the usability and acceptability of the wearable sensor, data aggregation platform and PROs.

Ethics and dissemination

This study has received approval from IRBs at Mayo Clinic, Yale University and the US Food and Drug Administration. Results will be made available to participants, funders, the research community and the public.

Trial registration number

NCT05214144; Pre-results.

Physical activity, acute severity and long-term consequences of COVID-19: an 18-month follow-up survey based on a Swedish national cohort

Por: Palstam · A. · Seljelid · J. · Persson · H. C. · Sunnerhagen · K. S.
Objective

To investigate how changes in levels of physical activity (PA) in regard to acute disease severity relate to perceived difficulties in performing daily life activities 18 months after COVID-19 infection.

Design

An observational study with an 18-month follow-up survey based on registry data from a national cohort.

Participants

5464 responders to the 18-month follow-up survey of a Swedish national cohort of 11 955 individuals on sick leave due to COVID-19 during the first wave of the pandemic.

Outcomes

The follow-up survey included questions on daily life activities, as well as present and retrospective level of PA. Changes in PA level from before COVID-19 to follow-up were assessed by the Saltin-Grimby PA Level Scale and analysed by the Wilcoxon signed-rank test. Comparisons of groups were analysed by the Student’s t-test, Mann-Whitney U test and 2. Multiple binary logistic regression was performed to assess the association of changes in PA with perceived difficulties in performing daily life activities.

Results

Among the 5464 responders (45% of national cohort), the PA level decreased. Hospitalised individuals had a lower PA level both prior to COVID-19 (p=0.035) and at the 18-month follow-up (p=0.008) compared with non-hospitalised responders. However, the level of PA decreased in both groups. A decrease in PA level increased the odds (OR 5.58, 95% CI 4.90 to 6.34) of having difficulties performing daily life activities.

Conclusions

PA levels were reduced 18 months after COVID-19 infection. A decrease in PA over that time was associated with perceived difficulties performing daily life activities 18 months after COVID-19. As PA is important in maintaining health and deconditioning takes time to reverse, this decline may have long-term implications for PA and health.

Feasibility of a pregnancy intervention mimicking viral transmission mitigation measures on the incidence of preterm birth in high-risk pregnant women enrolled in antenatal clinics in Melbourne, Australia: protocol for a pilot, randomised trial

Por: Sridhar · S. · Mol · B. W. · Hodges · R. · Palmer · K. R. · Sundram · S. · de Carvalho Pacagnella · R. · Souza · R. T. · Barbosa-Junior · F. · Mackin · D. · Said · J. · Rolnik · D. · Malhotra · A.
Introduction

Preterm birth is a leading cause of perinatal morbidity and mortality. During the COVID-19 pandemic, reduction in rates of preterm birth in women exposed to viral mitigation measures was reported by multiple studies. In addition, others and we observed a more pronounced reduction of preterm birth in women who had previously experienced a preterm birth. The aim of this pilot study is to establish the feasibility of a lifestyle intervention based on viral mitigation measures in high-risk pregnancies, with the ultimate aim to reduce the incidence of preterm birth.

Methods and analysis

One hundred pregnant women, enrolled in antenatal clinics at two tertiary maternity centres in Melbourne, Australia, who have had a previous preterm birth between 22 and 34 weeks gestation will be recruited. This is a two-arm, parallel group, open-label randomised controlled feasibility trial: 50 women will be randomised to the intervention group, where they will be requested to comply with a set of lifestyle changes (similar to the viral mitigation measures observed during the pandemic). Another 50 women will be randomised to the control group, where they will undergo standard pregnancy care. The primary outcome of this trial is feasibility, which will be assessed by measuring patient eligibility rate, recruitment rate, compliance rate and data completion rate. Secondary outcomes include incidence of preterm birth, maternal satisfaction, maternal quality of life and other pregnancy outcomes. Standard methods in statistical analysis for randomised controlled trials on an intention to treat basis will be followed.

Ethics and dissemination

This trial has been approved by the Monash Human Research Ethics Committee; approval reference number RES-22-0000-122A. Study findings will be reported and submitted to peer-reviewed journals for publication, and presentation at conferences.

Trial registration number

ACTRN12622000753752; Pre-results.

Determinants of access to and use of gestational diabetes mellitus services in Kenya: a multimethod case study protocol

Por: Obongo · A. · Tallarek · M. · Spallek · J.
Introduction

Gestational diabetes mellitus (GDM) is a growing public health issue in many low and middle-income countries (LMICs), making up about 90% of the global burden of GDM. Additionally, LMICs’ healthcare systems are already overwhelmed by the prevalence of communicable diseases. It is crucial to understand the patterns of GDM in sub-Saharan African countries. Early detection, lifestyle and medication interventions, regular prenatal visits and effective postpartum management can help avert the future development of type 2 diabetes. GDM services present opportunities for preventive and treatment strategies for women with GDM. However, various factors contribute to challenges and obstacles in accessing GDM services, particularly suboptimal postpartum screening and follow-up. This study aims to investigate the societal and healthcare factors that facilitate or hinder access to and use of GDM services, as well as the factors that promote or obstruct the management and treatment of GDM, in Kenya, using a postcolonial theoretical approach.

Methods and analysis

The proposed study design is a multimethod case study of Kenyan GDM services. Data analysis is descriptive and thematic using SPSS software and qualitative content analysis. Data will be drawn from document reviews from the National Health Services (NHS), conversations with experts, on-site observations, semistructured questionnaires and face-to-face interviews. The study subjects are purposively sampled healthcare providers (n=15) working in clinics and hospitals offering diabetes services, purposively sampled women who have been diagnosed with GDM identified from health records (n=15) and NHS experts (n=2). The study will take place in maternal healthcare services sites in national referral hospitals and/or private hospitals (two urban and two semiurban hospitals) in Nairobi and Kisumu, Kenya.

Ethics and dissemination

The study has obtained ethical approval from the ethical committees of three institutions: Brandenburg University of Technology Cottbus-Senftenberg (EK2021-03) in Germany and Jaramogi Oginga Odinga Teaching and Referral Hospital (ISERC/1B/VOL.II/558/21) and Maseno University (MSU/DRPI/MUERC/00969/21) in Kenya. A research permit has been granted by the National Commission for Science, Technology and Innovation in Kenya. Participation in the study requires a signed informed consent form. The study findings will be shared with the scientific community and the study sites through scientific journals, academic presentations and public health and diabetes-related posters.

Factors affecting the implementation of calcium supplementation strategies during pregnancy to prevent pre-eclampsia: a mixed-methods systematic review

Por: Cormick · G. · Moraa · H. · Zahroh · R. I. · Allotey · J. · Rocha · T. · Pena-Rosas · J. P. · Qureshi · Z. P. · Hofmeyr · G. J. · Mistry · H. · Smits · L. · Vogel · J. P. · Palacios · A. · Gwako · G. N. · Abalos · E. · Larbi · K. K. · Carroli · G. · Riley · R. · Snell · K. I. · Thorson · A.
Objectives

Daily calcium supplements are recommended for pregnant women from 20 weeks’ gestation to prevent pre-eclampsia in populations with low dietary calcium intake. We aimed to improve understanding of barriers and facilitators for calcium supplement intake during pregnancy to prevent pre-eclampsia.

Design

Mixed-method systematic review, with confidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations-Confidence in the Evidence from Reviews of Qualitative research approach.

Data sources

MEDLINE and EMBASE (via Ovid), CINAHL and Global Health (via EBSCO) and grey literature databases were searched up to 17 September 2022.

Eligibility criteria

We included primary qualitative, quantitative and mixed-methods studies reporting implementation or use of calcium supplements during pregnancy, excluding calcium fortification and non-primary studies. No restrictions were imposed on settings, language or publication date.

Data extraction and synthesis

Two independent reviewers extracted data and assessed risk of bias. We analysed the qualitative data using thematic synthesis, and quantitative findings were thematically mapped to qualitative findings. We then mapped the results to behavioural change frameworks to identify barriers and facilitators.

Results

Eighteen reports from nine studies were included in this review. Women reported barriers to consuming calcium supplements included limited knowledge about calcium supplements and pre-eclampsia, fears and experiences of side effects, varying preferences for tablets, dosing, working schedules, being away from home and taking other supplements. Receiving information regarding pre-eclampsia and safety of calcium supplement use from reliable sources, alternative dosing options, supplement reminders, early antenatal care, free supplements and support from families and communities were reported as facilitators. Healthcare providers felt that consistent messaging about benefits and risks of calcium, training, and ensuring adequate staffing and calcium supply is available would be able to help them in promoting calcium.

Conclusion

Relevant stakeholders should consider the identified barriers and facilitators when formulating interventions and policies on calcium supplement use. These review findings can inform implementation to ensure effective and equitable provision and scale-up of calcium interventions.

PROSPERO registration number

CRD42021239143.

Developing a model for decision-making around antibiotic prescribing for patients with COVID-19 pneumonia in acute NHS hospitals during the first wave of the COVID-19 pandemic: qualitative results from the Procalcitonin Evaluation of Antibiotic use in COV

Por: Henley · J. · Brookes-Howell · L. · Euden · J. · Pallmann · P. · Llewelyn · M. · Howard · P. · Powell · N. · Dark · P. · Szakmany · T. · Hellyer · T. P. · Albur · M. · Hamilton · R. · Prestwich · G. · Ogden · M. · Maboshe · W. · Sandoe · J. · Thomas-Jones · E. · Carrol · E. · on behalf of
Objective

To explore and model factors affecting antibiotic prescribing decision-making early in the pandemic.

Design

Semistructured qualitative interview study.

Setting

National Health Service (NHS) trusts/health boards in England and Wales.

Participants

Clinicians from NHS trusts/health boards in England and Wales.

Method

Individual semistructured interviews were conducted with clinicians in six NHS trusts/health boards in England and Wales as part of the Procalcitonin Evaluation of Antibiotic use in COVID-19 Hospitalised patients study, a wider study that included statistical analysis of procalcitonin (PCT) use in hospitals during the first wave of the pandemic. Thematic analysis was used to identify key factors influencing antibiotic prescribing decisions for patients with COVID-19 pneumonia during the first wave of the pandemic (March to May 2020), including how much influence PCT test results had on these decisions.

Results

During the first wave of the pandemic, recommendations to prescribe antibiotics for patients with COVID-19 pneumonia were based on concerns about secondary bacterial infections. However, as clinicians gained more experience with COVID-19, they reported increasing confidence in their ability to distinguish between symptoms and signs caused by SARS-CoV-2 viral infection alone, and secondary bacterial infections. Antibiotic prescribing decisions were influenced by factors such as clinician experience, confidence, senior support, situational factors and organisational influences. A decision-making model was developed.

Conclusion

This study provides insight into the decision-making process around antibiotic prescribing for patients with COVID-19 pneumonia during the first wave of the pandemic. The importance of clinician experience and of senior review of decisions as factors in optimising antibiotic stewardship is highlighted. In addition, situational and organisational factors were identified that could be optimised. The model presented in the study can be used as a tool to aid understanding of the complexity of the decision-making process around antibiotic prescribing and planning antimicrobial stewardship support in the context of a pandemic.

Trial registration number

ISRCTN66682918.

Understanding and addressing changing administrative workload in primary care in Canada: protocol for a mixed-method study

Por: Lavergne · M. R. · Moravac · C. · Bergin · F. · Buote · R. · Easley · J. · Grudniewicz · A. · Hedden · L. · Leslie · M. · McKay · M. · Marshall · E. G. · Martin-Misener · R. · Mooney · M. · Palmer · E. · Tracey · J.
Introduction

Many Canadians struggle to access the primary care they need while at the same time primary care providers report record levels of stress and overwork. There is an urgent need to understand factors contributing to the gap between a growing per-capita supply of primary care providers and declines in the availability of primary care services. The assumption of responsibility by primary care teams for services previously delivered on an in-patient basis, along with a rise in administrative responsibilities may be factors influencing reduced access to care.

Methods and analysis

In this mixed-methods study, our first objective is to determine how the volume of services requiring primary care coordination has changed over time in the Canadian provinces of Nova Scotia and New Brunswick. We will collect quantitative administrative data to investigate how services have shifted in ways that may impact administrative workload in primary care. Our second objective is to use qualitative interviews with family physicians, nurse practitioners and administrative team members providing primary care to understand how administrative workload has changed over time. We will then identify priority issues and practical response strategies using two deliberative dialogue events convened with primary care providers, clinical and system leaders, and policy-makers.

We will analyse changes in service use data between 2001/2002 and 2021/2022 using annual total counts, rates per capita, rates per primary care provider and per primary care service. We will conduct reflexive thematic analysis to develop themes and to compare and contrast participant responses reflecting differences across disciplines, payment and practice models, and practice settings. Areas of concern and potential solutions raised during interviews will inform deliberative dialogue events.

Ethics and dissemination

We received research ethics approval from Nova Scotia Health (#1028815). Knowledge translation will occur through dialogue events, academic papers and presentations at national and international conferences.

Autologous blood products: Leucocyte and Platelets Rich Fibrin (L-PRF) and Platelets Rich Plasma (PRP) gel to promote cutaneous ulcer healing - a systematic review

Por: Napit · I. B. · Shrestha · D. · Neupane · K. · Adhikari · A. · Dhital · R. · Koirala · R. · Gopali · L. · Ilozumba · O. · Gill · P. · Watson · S. I. · Choudhury · S. · Lilford · R. J.
Objective

To summarise evidence on the effectiveness of Platelet-Rich Plasma (PRP) gel and Leucocyte and Platelet Rich Fibrin (L-PRF) gel as agents promoting ulcer healing compared with the standard wound dressing techniques alone.

Design

Systematic review.

Eligibility criteria

Individual patient randomised controlled trials on skin ulcers of all types excluding traumatic lesions.

Intervention group: treatment with topical application of L-PRF gel or PRP gel to the wound surface.

Control group: treatment with standard skin ulcer care using normal saline, normgel or hydrogel dressings.

Information sources

Medline (Ovid), Excerpta Medica Database (EMBASE), Scopus, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Web of Science and manual search of studies from previous systematic reviews and meta-analyses. The papers published from 1946 to 2022 with no restriction on geography and language were included. The last date of the search was performed on 29 August 2022.

Data extraction and synthesis

Independent reviewers identified eligible studies, extracted data, assessed risk of bias using V.2 of the Cochrane risk-of-bias tool for randomised trials tool and assessed certainty of evidence by using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.

Main outcome measures

Time to complete healing, proportion healed at a given time and rate of healing.

Results

Seven studies met the inclusion criteria, five using PRP gel and two using L-PRF gel. One study showed a better proportion of complete healing, three reported reduced meantime to complete healing and five showed improved rate of healing per unit of time in the intervention group. The risk of bias was high across all studies with one exception and the GRADE showed very low certainty of evidence.

Conclusion

The findings show potential for better outcomes in the intervention; however, the evidence remains inconclusive highlighting a large research gap in ulcer treatment and warrant better-designed clinical trials.

PROSPERO registration number

CRD42022352418.

Effect of synchronous remote-based interventions on suicidal behaviours: protocol for a systematic review and meta-analysis

Por: Comendador · L. · Jimenez-Villamizar · M. P. · Losilla · J.-M. · Sanabria-Mazo · J. P. · Mateo-Canedo · C. · Cebria · A. I. · Sanz · A. · Palao · D. J.
Introduction

Suicide is among the leading causes of preventable death worldwide. The impact of suicide affects the personal, social and economic levels. Therefore, its prevention is a priority for public health systems. Previous studies seem to support the efficacy of providing active contact to people who have made a suicide attempt. The current systematic review and meta-analysis aims to investigate the efficacy of distance suicide prevention strategies implemented through synchronous technology-based interventions.

Methods and analysis

This protocol is designed according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. The bibliographical searches were conducted in the databases PubMed, PsycINFO, Scopus and Web of Science in April 2022, with no restrictions on the time of publication and limited to publications in English or Spanish. The search strategy was performed using free-text terms and Medical Subject Headings terms: suicide, follow-up, synchronous, remote, telehealth, telephone, hotline, video-conference and text message. Two reviewers will independently conduct study screening, selection process, data extraction and risk of bias assessment. The analysis and synthesis of the results will be both qualitative and quantitative. A narrative synthesis, presented in a comprehensive table, will be performed and meta-analysis will be conducted, as appropriate, if sufficient data are provided.

Ethics and dissemination

The present review and meta-analysis will not require ethical approval, as it will use data collected from previously published primary studies. The findings of this review will be published in peer-reviewed journals and widely disseminated.

PROSPERO registration number

CRD42021275044.

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