scholarly journals PRIME (Positive Transitions Through the Menopause) Study: a protocol for a mixed-methods study investigating the impact of the menopause on the health and well-being of women living with HIV in England

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e025497 ◽  
Author(s):  
Shema Tariq ◽  
Fiona M Burns ◽  
Richard Gilson ◽  
Caroline Sabin
Keyword(s):  
Mixed Methods ◽  
Research Ethics ◽  
Well Being ◽  
Ethics Committee ◽  
Phase 2 ◽  
Research Ethics Committee ◽  
Women Living With Hiv ◽  
Living With Hiv ◽  
The Impact ◽  
Health And Well Being

IntroductionAdvances in antiretroviral therapy have transformed HIV into a long-term condition with near-normal life expectancy for those in whom viral replication is well controlled on treatment. This means that age-related events, including menopause, is of increasing importance in the care of people living with HIV. The PRIME (Positive Transitions Through the Menopause) Study aims to explore the impact of the menopause on the health and well-being of women living with HIV (WLHIV).Methods and analysisThe PRIME Study is a multicentre, mixed-methods observational study deploying a multiphase sequential design with explanatory and exploratory phases. Phase 1 comprised three focus group discussions with WLHIV. In phase 2 we aimed to administer questionnaires comprising detailed assessment of menopausal status and symptoms to 1500 WLHIV aged 45–60 attending HIV clinics in England. Phase 3 comprised semistructured interviews with a subsample of phase 2 participants. Ongoing quantitative follow-up of 100 participants is planned between October 2018 and September 2019. Qualitative and quantitative data will be kept analytically distinct and analysed using appropriate methods. We will integrate quantitative and qualitative findings using coding matrices.Ethics and disseminationThe PRIME Study has ethical approval from the South East Coast-Surrey Research Ethics Committee on behalf of all National Health Service (NHS) sites, and approval from University College London Research Ethics Committee for qualitative work conducted in non-NHS sites. In conjunction with the study Expert Advisory Group (which includes WLHIV), we have drafted a dissemination strategy that takes into account a wide range of stakeholders, including patients, policy makers and healthcare providers. This includes at least five empirical research papers to be submitted to peer-reviewed journals, as well as an accessible report aimed primarily at a non-technical audience (published in May 2018 and launched at a live-streamed event). Both quantitative and qualitative data are held by the PRIME Study team and are available by request.

scholarly journals A study to evaluate the effectiveness of Best Beginnings’ Baby Buddy phone app in England: a protocol paper

2018 ◽  
Vol 20 ◽  
Author(s):  
Toity Deave ◽  
Sally Kendal ◽  
Raghu Lingam ◽  
Crispin Day ◽  
Trudy Goodenough ◽  
...  
Keyword(s):  
Cohort Study ◽  
Pregnant Women ◽  
Research Ethics ◽  
Health Professionals ◽  
Self Efficacy ◽  
Well Being ◽  
Ethics Committee ◽  
The West ◽  
Research Ethics Committee ◽  
The Impact

AbstractIntroductionDevelopments in information and communication technologies have enabled electronic health and seen a huge expansion over the last decade. This has increased the possibility of self-management of health issues.PurposeTo assess the effectiveness of the Baby Buddy app on maternal self-efficacy and mental well-being three months post-birth in a sample of mothers recruited antenatally. In addition, to explore when, why and how mothers use the app and consider any benefits the app may offer them in relation to their parenting, health, relationships or communication with their child, friends, family members or health professionals.MethodsWe will use a mixed-methods approach, a cohort study, a qualitative element and analysis of in-app data. Participants will be first-time pregnant women, aged 16 years and over, between 12 and 16 weeks of gestation and recruited from five English study sites.Evaluation planWe will compare maternal self-efficacy and mental health at three months post-delivery in mothers who have downloaded the Baby Buddy app compared with those that have not downloaded the app, controlling for confounding factors. Women will be recruited antenatally between 12 and 16 weeks of gestation. Further follow-ups will take place at 35 weeks of gestation and three months post-birth. Data from the cohort study will be supplemented by in-app data that will include, for example, patterns of usage. Qualitative data will assess the impact of the app on the lives of pregnant women and health professionals using both focus groups and interviews.EthicsApproval from the West Midlands-South Birmingham Research Ethics Committee (NRES) (16/WM/0029) and the University of the West of England, Bristol, Research Ethics Committee (HAS.16.08.001).DisseminationFindings of the study will be published in peer reviewed and professional journals, presented locally, nationally and at international conferences. Participants will receive a summary of the findings and the results will be published on Best Beginnings’ website.

scholarly journals Better evidence for earlier assessment and surgical intervention for refractory epilepsy (The BEST study): a mixed methods study protocol

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e017148 ◽  
Author(s):  
Frances Rapport ◽  
Patti Shih ◽  
Rebecca Mitchell ◽  
Armin Nikpour ◽  
Andrew Bleasel ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Health Services ◽  
Research Ethics ◽  
Surgical Intervention ◽  
Refractory Epilepsy ◽  
Ethics Committee ◽  
Local Health ◽  
Health Services Use ◽  
Research Ethics Committee ◽  
Resective Surgery

IntroductionOne-third of patients with refractory epilepsy may be candidates for resective surgery, which can lead to positive clinical outcomes if efficiently managed. In Australia, there is currently between a 6-month and 2-year delay for patients who are candidates for respective epilepsy surgery from the point of referral for surgical assessment to the eventual surgical intervention. This is a major challenge for implementation of effective treatment for individuals who could potentially benefit from surgery. This study examines implications of delays following the point of eligibility for surgery, in the assessment and treatment of patients, and the factors causing treatment delays.Methods and analysisMixed methods design: Observations of qualitative consultations, patient and healthcare professional interviews, and health-related quality of life assessments for a group of 10 patients and six healthcare professionals (group 1); quantitative retrospective medical records’ reviews examining longitudinal outcomes for 50 patients assessed for, or undergoing, resective surgery between 2014 and 2016 (group 2); retrospective epidemiological study of all individuals hospitalised with a diagnosis of epilepsy in New South Wales (NSW) in the last 5 years (2012–2016; approximately 11 000 hospitalisations per year, total 55 000), examining health services’ use and treatment for individuals with epilepsy, including refractory surgery outcomes (group 3).Ethics and disseminationEthical approval has been granted by the North Sydney Local Health District Human Research Ethics Committee (HREC/17/HAWKE/22) and the NSW Population & Health Services Research Ethics Committee (HREC/16/CIPHS/1). Results will be disseminated through publications, reports and conference presentations to patients and families, health professionals and researchers.

scholarly journals Protocol for the CONNECT project: a mixed methods study investigating patient preferences for communication technology use in orthopaedic rehabilitation consultations

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e035210 ◽  
Author(s):  
Anthony William Gilbert ◽  
Jeremy Jones ◽  
Maria Stokes ◽  
Emmanouil Mentzakis ◽  
Carl R May
Keyword(s):  
Mixed Methods ◽  
Research Ethics ◽  
Phase Ii ◽  
Communication Technology ◽  
Patient Preferences ◽  
Technology Use ◽  
Ethics Committee ◽  
Phase Iii ◽  
Research Ethics Committee ◽  
Phase Iv

IntroductionTechnology has been placed at the centre of global health policy and has been cited as having the potential to increase efficiency and remove geographical boundaries for patients to access care. Communication technology may support patients with orthopaedic problems, which is one of the leading causes of disability worldwide. There are several examples of technology being used in clinical research, although uptake in practice remains low. An understanding of patient preferences will support the design of a communication technology supported treatment pathway for patients undergoing orthopaedic rehabilitation.Methods and analysisThis mixed methods project will be conducted in four phases. In phase I, a systematic review of qualitative studies reporting communication technology use for orthopaedic rehabilitation will be conducted to devise a taxonomy of tasks patients’ face when using these technologies to access their care. In phase II, qualitative interviews will investigate how the work of being a patient changes during face-to-face and communication technology consultations and how these changes influence preference. In phase III, a discrete choice experiment will investigate the factors that influence preferences for the use of communication technology for orthopaedic rehabilitation consultations. Phase IV will be a practical application of these results. We will design a ‘minimally disruptive’ communication technology supported pathway for patients undergoing orthopaedic rehabilitation.Ethics and disseminationThe design of a pathway and underpinning patient preference will assist in understanding factors that might influence technology implementation for clinical care. This study requires ethical approval for phases II, III and IV. Approvals have been received for phase II (approval received on 4 December 2016 from the South Central-Oxford C Research Ethics Committee (IRAS ID: 255172, REC Reference 18/SC/0663)) and phase III (approval received on 18 October 2019 from the London-Hampstead Research Ethics Committee (IRAS ID: 248064, REC Reference 19/LO/1586)) and will be sought for phase IV. All participants will provide informed written consent prior to being enrolled onto the study.PROSPERO registration numberCRD42018100896.

scholarly journals Impact of legal status change on undocumented migrants’ health and well-being (Parchemins): protocol of a 4-year, prospective, mixed-methods study

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e028336 ◽  
Author(s):  
Yves Jackson ◽  
Delphine S Courvoisier ◽  
Aline Duvoisin ◽  
Giovanni Ferro-Luzzi ◽  
Patrick Bodenmann ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Health Status ◽  
Legal Status ◽  
Well Being ◽  
Living Conditions ◽  
Mixed Methods Study ◽  
Control Group ◽  
Undocumented Migrants ◽  
The Impact ◽  
Health And Well Being

IntroductionMigrants without residency permit, known as undocumented, tend to live in precarious conditions and be exposed to an accumulation of adverse determinants of health. Only scarce evidence exists on the social, economic and living conditions-related factors influencing their health status and well-being. No study has assessed the impact of legal status regularisation. The Parchemins study is the first prospective, mixed-methods study aiming at measuring the impact on health and well-being of a regularisation policy on undocumented migrants in Europe.Methods and analysisThe Parchemins study will compare self-rated health and satisfaction with life in a group of adult undocumented migrants who qualify for applying for a residency permit (intervention group) with a group of undocumented migrants who lack one or more eligibility criteria for regularisation (control group) in Geneva Canton, Switzerland. Asylum seekers are not included in this study. The total sample will include 400 participants. Data collection will consist of standardised questionnaires complemented by semidirected interviews in a subsample (n=38) of migrants qualifying for regularisation. The baseline data will be collected just before or during the regularisation, and participants will subsequently be followed up yearly for 3 years. The quantitative part will explore variables about health (ie, health status, occupational health, health-seeking behaviours, access to care, healthcare utilisation), well-being (measured by satisfaction with different dimensions of life), living conditions (ie, employment, accommodation, social support) and economic situation (income, expenditures). Several confounders including sociodemographic characteristics and migration history will be collected. The qualitative part will explore longitudinally the experience of change in legal status at individual and family levels.Ethics and disseminationThis study was approved by the Ethics Committee of Geneva, Switzerland. All participants provided informed consent. Results will be shared with undocumented migrants and disseminated in scientific journals and conferences. Fully anonymised data will be available to researchers.

scholarly journals Understanding and responding to the cost and health impact of short-term health staffing in remote and rural Aboriginal and Torres Strait Islander community-controlled health services: a mixed methods study protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e043902
Author(s):  
Michelle S Fitts ◽  
John Humphreys ◽  
Terry Dunbar ◽  
Lisa Bourke ◽  
Edward Mulholland ◽  
...  
Keyword(s):  
Health Services ◽  
Research Ethics ◽  
Primary Healthcare ◽  
Ethics Committee ◽  
Mixed Methods Study ◽  
Short Term ◽  
Human Research ◽  
Research Ethics Committee ◽  
Human Research Ethics ◽  
The Impact

IntroductionAccess to high-quality primary healthcare is limited for remote residents in Australia. Increasingly, remote health services are reliant on short-term or ‘fly-in, fly-out/drive-in, drive-out’ health workforce to deliver primary healthcare. A key strategy to achieving health service access equity, particularly evident in remote Australia, has been the development of Aboriginal Community Controlled Health Services (ACCHSs). This study aims to generate new knowledge about (1) the impact of short-term staffing in remote and rural ACCHSs on Aboriginal and Torres Strait Islander communities; (2) the potential mitigating effect of community control; and (3) effective, context-specific evidence-based retention strategies.Methods and analysisThis paper describes a 3-year, mixed methods study involving 12 ACCHSs across three states. The methods are situated within an evidence-based programme logic framework for rural and remote primary healthcare services. Quantitative data will be used to describe staffing stability and turnover, with multiple regression analyses to determine associations between independent variables (population size, geographical remoteness, resident staff turnover and socioeconomic status) and dependent variables related to patient care, service cost, quality and effectiveness. Qualitative assessment will include interviews and focus groups with clinical staff, clinic users, regionally-based retrieval staff and representatives of jurisdictional peak bodies for the ACCHS sector, to understand the impact of short-term staff on quality and continuity of patient care, as well as satisfaction and acceptability of services.Ethics and disseminationThe study has ethics approval from the Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (project number DR03171), Central Australian Human Research Ethics Committee (CA-19-3493), Western Australian Aboriginal Health Ethics Committee (WAAHEC-938) and Far North Queensland Human Research Ethics Committee (HREC/2019/QCH/56393). Results will be disseminated through peer-reviewed journals, the project steering committee and community/stakeholder engagement activities to be determined by each ACCHS.

scholarly journals Current provision of myelopathy education in medical schools in the UK: protocol for a national medical student survey

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e035563
Author(s):  
Oliver Mowforth ◽  
Benjamin Davies ◽  
Max Stewart ◽  
Sam Smith ◽  
Alice Willison ◽  
...  
Keyword(s):  
Medical Student ◽  
Research Ethics ◽  
Medical Schools ◽  
Ethics Committee ◽  
Psychology Research ◽  
Research Ethics Committee ◽  
University Of Cambridge ◽  
Ethical Approval ◽  
The Uk ◽  
The Impact

IntroductionDegenerative cervical myelopathy (DCM) is a common, disabling and progressive neurological condition triggered by chronic compression of the cervical spinal cord by surrounding degenerative changes. Early diagnosis and specialist management are essential to reduce disability, yet time to diagnosis is typically prolonged. Lack of sufficient representation of DCM in undergraduate and postgraduate medical curricula may contribute to the poor recognition of DCM by non-specialist doctors in clinical practice.In this study, our objective, therefore, is to assess DCM teaching provision in medical schools throughout the UK and to assess the impact of teaching on the DCM knowledge of UK medical students.Methods and analysisA 19-item questionnaire capturing data on medical student demographics, myelopathy teaching and myelopathy knowledge was designed. Ethical approval was granted by the Psychology Research Ethics Committee, University of Cambridge. An online survey was hosted on Myelopathy.org, an international myelopathy charity. Students studying at a UK medical school are eligible for inclusion. The survey is advertised nationally through university social media pages, university email bulletins and the national student network of Myelopathy.org. Advertisements are scheduled monthly over a 12-month recruitment period. Participation is incentivised by entering consenting participants of completed surveys to an Amazon voucher prize draw. Responses are anonymised using participant-chosen unique identifier codes. A participant information sheet followed by an explicit survey question captures participant informed consent. Regular updates on the progress of the study will be published on Myelopathy.org.Ethics and DisseminationEthical approval for the study was granted by the Psychology Research Ethics Committee, University of Cambridge (PRE.2018.099). The findings of the study described in this protocol, and all other related work, will be submitted for publication in a peer-reviewed journal and will be presented at scientific conferences.

scholarly journals Well-being programmes in prisons in England and Wales: a mixed-methods study

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Mary Turner ◽  
Nigel King ◽  
Dara Mojtahedi ◽  
Viv Burr ◽  
Victoria Gall ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Ad Hoc ◽  
Phase 1 ◽  
National Policy ◽  
Well Being ◽  
Phase 2 ◽  
Prison Staff ◽  
England And Wales ◽  
Content Type ◽  
Health And Well Being

Purpose In the past decade, there has been growing awareness of well-being and its importance and an increase in the development of activities or programmes aimed at improving well-being. The purpose of this study is to investigate what well-being programmes were being offered to prisoners in England and Wales and what benefits and other outcomes were experienced. Design/methodology/approach The study used a mixed-methods exploratory design in two phases. Phase 1 was a questionnaire survey of all adult prisons in England and Wales, completed by prison staff. In Phase 2, a sample of survey respondents took part in in-depth interviews. Findings The programmes identified in Phase 1 included physical activities, creative arts, mindfulness, horticulture, reading and animal-assisted activities. Prison staff reported a range of universally positive outcomes shared by all programmes, including enthusiasm from prisoners, enjoyment of the activities and being able to do something different from the usual prison routine. However, in Phase 2, interviewees rarely mentioned direct health and well-being benefits. The impetus for programmes was varied and there was little reference to national policy on health and well-being; this reflected the ad hoc way in which programmes are developed, with a key role being played by the Well-being Officer, where these were funded. Originality/value The literature on well-being programmes in prisons is limited and tends to focus on specific types of initiatives, often in a single prison. This study contributes by highlighting the range of activities across prisons and elucidating the perspectives of those involved in running such programmes.

scholarly journals A pragmatic health centre-based evaluation comparing the effectiveness of a PCV13 schedule change from 3+0 to 2+1 in a high pneumococcal carriage and disease burden setting in Malawi: a study protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050312
Author(s):  
Todd D Swarthout ◽  
Ana Ibarz-Pavon ◽  
Gift Kawalazira ◽  
George Sinjani ◽  
James Chirombo ◽  
...  
Keyword(s):  
Research Ethics ◽  
Health Centre ◽  
Ethics Committee ◽  
Research Ethics Committee ◽  
Pneumococcal Carriage ◽  
Health Centres ◽  
Schedule Change ◽  
The University ◽  
The Impact ◽  
Carriage Prevalence

IntroductionStreptococcus pneumoniae (the pneumococcus) is commonly carried as a commensal bacterium in the nasopharynx but can cause life-threatening disease. Transmission occurs by human respiratory droplets and interruption of this process provides herd immunity. A 2017 WHO Consultation on Optimisation of pneumococcal conjugate vaccines (PCV) Impact highlighted a substantial research gap in investigating why the impact of PCV vaccines in low-income countries has been lower than expected. Malawi introduced the 13-valent PCV (PCV13) into the national Expanded Programme of Immunisations in 2011, using a 3+0 (3 primary +0 booster doses) schedule. With evidence of greater impact of a 2+1 (2 primary +1 booster dose) schedule in other settings, including South Africa, Malawi’s National Immunisations Technical Advisory Group is seeking evidence of adequate superiority of a 2+1 schedule to inform vaccine policy.MethodsA pragmatic health centre-based evaluation comparing impact of a PCV13 schedule change from 3+0 to 2+1 in Blantyre district, Malawi. Twenty government health centres will be randomly selected, with ten implementing a 2+1 and 10 to continue with the 3+0 schedule. Health centres implementing 3+0 will serve as the direct comparator in evaluating 2+1 providing superior direct and indirect protection against pneumococcal carriage. Pneumococcal carriage surveys will evaluate carriage prevalence among children 15–24 months, randomised at household level, and schoolgoers 5–10 years of age, randomly selected from school registers. Carriage surveys will be conducted 18 and 33 months following 2+1 implementation.AnalysisThe primary endpoint is powered to detect an effect size of 50% reduction in vaccine serotype (VT) carriage among vaccinated children 15–24 months old, expecting a 14% and 7% VT carriage prevalence in the 3+0 and 2+1 arms, respectively.Ethics and disseminationThe study has been approved by the Malawi College of Medicine Research Ethics Committee (COMREC; Ref: P05.19.2680), the University College London Research Ethics Committee (Ref: 8603.002) and the University of Liverpool Research Ethics Committee (Ref: 5439). The results from this study will be actively disseminated through manuscript publications and conference presentations.Trial registration numberNCT04078997.

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