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Conceptual framework for establishing twins prevention and continuous health promotion programme: a qualitative study

Por: Abtahi · H. · Khoshnam-Rad · N. · Gholamzadeh · M. · Daraie · M. · Sabouri · F.
Background

Twin registries and cohorts face numerous challenges, including significant resource allocation, twins’ recruitment and retention. This study aimed to assess expert feedback on a proposed pragmatic idea for launching a continuous health promotion and prevention programme (HPPP) to establish and maintain twin cohorts.

Design

A qualitative study incorporating an inductive thematic analysis.

Setting

Tehran University of Medical Sciences.

Participants

Researchers with expertise in twin studies participated in our study.

Analysis and design

Expert opinions were gathered through focus group discussions (FGDs). Thematic analysis was employed to analyse the findings and develop a model for designing a comprehensive, long-term health promotion programme using ATLAS.ti software. Additionally, a standardised framework was developed to represent the conceptual model of the twin HPPP.

Results

Eight FGDs were conducted, involving 16 experts. Thematic analysis identified eight themes and seven subthemes that encompassed the critical aspects of a continuous monitoring programme for twin health. Based on these identified themes, a conceptual framework was developed for the implementation of an HPPP tailored for twins.

Conclusion

This study presented the initial endeavour to establish a comprehensive and practical solution in the form of a continuous HPPP designed to tackle the obstacles of twins’ cohorts.

Decentralising chronic disease management in sub-Saharan Africa: a protocol for the qualitative process evaluation of community-based integrated management of HIV, diabetes and hypertension in Tanzania and Uganda

Por: Van Hout · M.-C. · Akugizibwe · M. · Shayo · E. H. · Namulundu · M. · Kasujja · F. X. · Namakoola · I. · Birungi · J. · Okebe · J. · Murdoch · J. · Mfinanga · S. G. · Jaffar · S.
Introduction

Sub-Saharan Africa continues to experience a syndemic of HIV and non-communicable diseases (NCDs). Vertical (stand-alone) HIV programming has provided high-quality care in the region, with almost 80% of people living with HIV in regular care and 90% virally suppressed. While integrated health education and concurrent management of HIV, hypertension and diabetes are being scaled up in clinics, innovative, more efficient and cost-effective interventions that include decentralisation into the community are required to respond to the increased burden of comorbid HIV/NCD disease.

Methods and analysis

This protocol describes procedures for a process evaluation running concurrently with a pragmatic cluster-randomised trial (INTE-COMM) in Tanzania and Uganda that will compare community-based integrated care (HIV, diabetes and hypertension) with standard facility-based integrated care. The INTE-COMM intervention will manage multiple conditions (HIV, hypertension and diabetes) in the community via health monitoring and adherence/lifestyle advice (medicine, diet and exercise) provided by community nurses and trained lay workers, as well as the devolvement of NCD drug dispensing to the community level. Based on Bronfenbrenner’s ecological systems theory, the process evaluation will use qualitative methods to investigate sociostructural factors shaping care delivery and outcomes in up to 10 standard care facilities and/or intervention community sites with linked healthcare facilities. Multistakeholder interviews (patients, community health workers and volunteers, healthcare providers, policymakers, clinical researchers and international and non-governmental organisations), focus group discussions (community leaders and members) and non-participant observations (community meetings and drug dispensing) will explore implementation from diverse perspectives at three timepoints in the trial implementation. Iterative sampling and analysis, moving between data collection points and data analysis to test emerging theories, will continue until saturation is reached. This process of analytic reflexivity and triangulation across methods and sources will provide findings to explain the main trial findings and offer clear directions for future efforts to sustain and scale up community-integrated care for HIV, diabetes and hypertension.

Ethics and dissemination

The protocol has been approved by the University College of London (UK), the London School of Hygiene and Tropical Medicine Ethics Committee (UK), the Uganda National Council for Science and Technology and the Uganda Virus Research Institute Research and Ethics Committee (Uganda) and the Medical Research Coordinating Committee of the National Institute for Medical Research (Tanzania). The University College of London is the trial sponsor. Dissemination of findings will be done through journal publications and stakeholder meetings (with study participants, healthcare providers, policymakers and other stakeholders), local and international conferences, policy briefs, peer-reviewed journal articles and publications.

Trial registration number

ISRCTN15319595.

Operational priorities for engaging with Indias private healthcare sector for the control of tuberculosis: a modelling study

Por: Ricks · S. · Singh · A. · Sodhi · R. · Pal · A. · Arinaminpathy · N.
Objectives

To estimate the potential impact of expanding services offered by the Joint Effort for Elimination of Tuberculosis (JEET), the largest private sector engagement initiative for tuberculosis (TB) in India.

Design

We developed a mathematical model of TB transmission dynamics, coupled with a cost model.

Setting

Ahmedabad and New Delhi, two cities with contrasting levels of JEET coverage.

Participants

Estimated patients with TB in Ahmedabad and New Delhi.

Interventions

We investigated the epidemiological impact of expanding three different public–private support agency (PPSA) services: provider recruitment, uptake of cartridge-based nucleic acid amplification tests and uptake of adherence support mechanisms (specifically government supplied fixed-dose combination drugs), all compared with a continuation of current TB services.

Results

Our results suggest that in Delhi, increasing the use of adherence support mechanisms among private providers should be prioritised, having the lowest incremental cost-per-case-averted between 2020 and 2035 of US$170 000 (US$110 000–US$310 000). Likewise in Ahmedabad, increasing provider recruitment should be prioritised, having the lowest incremental cost-per-case averted of US$18 000 (US$12 000–US$29 000).

Conclusion

Results illustrate how intervention priorities may vary in different settings across India, depending on local conditions, and the existing degree of uptake of PPSA services. Modelling can be a useful tool for identifying these priorities for any given setting.

Roles of health system leadership under emergency in drought-affected districts in northeast Uganda: a mixed-method study

Por: Njuguna · C. · Tola · H. · Maina · B. N. · Magambo · K. N. · Namukose · S. · Kamau · S. · Tegegn · Y. W.
Objective

Health system leadership plays a critical role in sustaining healthcare delivery during emergencies. Thus, we aimed to assess the contribution of health system leadership in sustaining healthcare delivery under emergency conditions based on adaptive leadership theoretical framework.

Design

We employed a concurrent mixed-methods study approach to assess health system leadership roles during emergency. This involved a quantitative survey administered to 150 health facilities managers/service focal persons selected via multistage sampling method from 15 districts, and qualitative interviews with 48 key informants who purposively selected.

Participants

We interviewed health facility managers, services focal persons, district health officers and residential district commissioners. We also reviewed weekly emergency situation reports and other relevant documents related to the emergency response. We used structured questionnaire, observation checklist and semistructured questionnaire to collect data. We employed descriptive statistics to analyse quantitative data and thematic analysis for qualitative data.

Main outcome

Health system leadership contributions in sustaining healthcare delivery during emergencies.

Results

Health system leadership was effective in leading emergency response and ensuring the continuity of health service during emergencies. Community engagement, partners coordination and intersectoral collaboration were effectively used in the emergency response and ensuring continuity of healthcare delivery. Deployment of experienced personnel and essential medical and non-medical supplies played a critical role in the continuity of health service. Availability of incidence management teams across health system significantly contributed to health system leadership. Participation of village health teams in community engagement and information communication helped in the success of health system leadership under emergency.

Conclusion

Adaptive health system leadership played a crucial role in managing health services delivery under emergency conditions. Effective partnership coordination and collaboration across sectors, frequent information communication, building local actor capacity and implementing scheduled supportive supervisions emerged as key strategies for sustaining health services during emergencies.

Impact of the economic crisis, COVID-19 and the Beirut explosion on ophthalmology training in Lebanon: an observational cohort survey-based study

Por: Ghannam · A. B. · Ibrahim · H. A. · Hammoud · B. · Hamam · R.
Objectives

The objective of the study is to investigate the effects of the COVID-19 pandemic, the economic crisis and the Beirut explosion on the training and work of ophthalmology residents and faculty in Lebanon.

Design

This is an observational cohort survey-based research conducted between January and December 2022.

Setting

The study targeted all ophthalmology residents and core faculty in Lebanon.

Participants

A total of 52 participants, including 27 residents and 25 core faculty members, completed the survey.

Primary outcome measure

Primary outcomes comprised the subjectively reported effect of the three major external stressors on the training and well-being of ophthalmology trainees and educators in Lebanon.

Results

The study found that the majority of ophthalmology residents and core faculty members were significantly affected by the COVID-19 pandemic, Beirut explosion and the economic crisis in Lebanon. Significant percentage reported financial burden, decrease in outpatient and surgical load and educational activities. Furthermore, most participants reported higher levels of stress, anxiety and depression during the time of crises.

Conclusions

This study emphasises the need to support healthcare professionals during times of crisis, as they are on the frontlines and can experience high levels of stress, anxiety and depression. By providing support and resources to healthcare professionals, they can better cope with the challenges they face and continue to provide essential care to their patients.

Interventions in adult patients with multimorbidity in low-income and middle-income countries: protocol for a mixed-methods systematic review

Por: George · T. · Manski-Nankervis · J.-A. · Klaic · M. · Kang · G. · Sudarsanam · T. D.
Introduction

Multimorbidity, the coexistence of two or more chronic conditions in the same individual, is a major public health problem in low-income and middle-income countries (LMICs). The use of single-disease guidelines contributes to polypharmacy, fragmented care and increased treatment burden. Health systems in LMICs are very different from those in high-income countries, and adapting interventions from one to the other may not be feasible. This review aims to systematically present the current evidence for interventions for multimorbidity in the LMIC setting.

Methods and analysis

In this mixed-methods systematic review, we will include all studies of interventions for the care of adults (>18 years of age) with multimorbidity (defined as the presence of two or more chronic illnesses in an individual) in any healthcare organisation (primary, secondary or tertiary care) in an LMIC (as defined by the World Bank), published between 2000 and March 2023. All primary study designs will be included. Studies reported in languages other than English and those describing interventions classified as ‘financial’ or ‘governance arrangement’ according to the Cochrane Effective Practice and Organisation of Care classification will be excluded. MEDLINE, PubMed, Cochrane Library, TRIP, SCOPUS and the 3ie databases will be searched. The titles will be screened by one author, and two authors will independently screen all included abstracts and full texts. A third author will resolve conflicts at every stage. Studies will be reviewed for quality of evidence using appropriate tools. Epidemiological, intervention and outcome data will be extracted and summarised. Outcomes of interest for LMICs defined by the Global Alliance for Chronic Diseases research group will be analysed. Subgroup analysis according to study types and study settings will be done.

Ethics and dissemination

No ethics approval is required for this systematic review. Results will be disseminated through publication in an open-access journal and presentation at conferences.

PROSPERO registration number

CRD42023391897.

AI assisted reader evaluation in acute CT head interpretation (AI-REACT): protocol for a multireader multicase study

Por: Fu · H. · Novak · A. · Robert · D. · Kumar · S. · Tanamala · S. · Oke · J. · Bhatia · K. · Shah · R. · Romsauerova · A. · Das · T. · Espinosa · A. · Grzeda · M. T. · Narbone · M. · Dharmadhikari · R. · Harrison · M. · Vimalesvaran · K. · Gooch · J. · Woznitza · N. · Salik · N. · Campbell · A.
Introduction

A non-contrast CT head scan (NCCTH) is the most common cross-sectional imaging investigation requested in the emergency department. Advances in computer vision have led to development of several artificial intelligence (AI) tools to detect abnormalities on NCCTH. These tools are intended to provide clinical decision support for clinicians, rather than stand-alone diagnostic devices. However, validation studies mostly compare AI performance against radiologists, and there is relative paucity of evidence on the impact of AI assistance on other healthcare staff who review NCCTH in their daily clinical practice.

Methods and analysis

A retrospective data set of 150 NCCTH will be compiled, to include 60 control cases and 90 cases with intracranial haemorrhage, hypodensities suggestive of infarct, midline shift, mass effect or skull fracture. The intracranial haemorrhage cases will be subclassified into extradural, subdural, subarachnoid, intraparenchymal and intraventricular. 30 readers will be recruited across four National Health Service (NHS) trusts including 10 general radiologists, 15 emergency medicine clinicians and 5 CT radiographers of varying experience. Readers will interpret each scan first without, then with, the assistance of the qER EU 2.0 AI tool, with an intervening 2-week washout period. Using a panel of neuroradiologists as ground truth, the stand-alone performance of qER will be assessed, and its impact on the readers’ performance will be analysed as change in accuracy (area under the curve), median review time per scan and self-reported diagnostic confidence. Subgroup analyses will be performed by reader professional group, reader seniority, pathological finding, and neuroradiologist-rated difficulty.

Ethics and dissemination

The study has been approved by the UK Healthcare Research Authority (IRAS 310995, approved 13 December 2022). The use of anonymised retrospective NCCTH has been authorised by Oxford University Hospitals. The results will be presented at relevant conferences and published in a peer-reviewed journal.

Trial registration number

NCT06018545.

Cohort profile: rationale and design of the Resource Center for Health Science (RECHS) project - a study of health hazards and medical cost burden among the Japanese population

Por: Morishita · T. · Takemura · M. · Hayashi · M. · Saito · K. · Yamamoto · Y. · Tsurumi · H. · Matsunami · H.
Purpose

The increased global burden of non-communicable diseases and mental disorders is an urgent health challenge for countries around the entire world, especially those experiencing super-ageing societies, where over 21% of the population is age 65 years or older. Japan is the world’s most rapidly ageing society, and as a result, medical costs are also rising dramatically. With the aims of establishing a foundational framework for future research efforts, primarily focusing on the development of a personal health record (PHR) system, and creating a long-term repository for bioresources integrated with PHRs, this study investigated potential health risks and future healthcare burdens based on a longitudinal analysis of health records.

Participants

The Resource Center for Health Science (RECHS) project is a long-term, prospective biobank project, population and health check-up-based cohort that primarily investigates the associations between lifestyle and environmental factors and some surrogate markers of non-communicable diseases, such as diabetes, hypertension, cardiovascular disease and cancer. Starting in 2010, we initiated an annual cohort study among voluntary participants recruited from health check-up programmes and collected data from the following sources: a self-administered baseline questionnaire that included items on dietary habits and stress, a Brief Self-Administered Diet History Questionnaire, the Centre for Epidemiologic Studies Depression Scale and the General Health Questionnaire-28.

Findings to date

For this prospective cohort study, we planned to enrol approximately 10 000 participants. We collected and stored serum samples from all participants for future analyses. The study participants who still were able to participate in these health check-ups and their outcomes were then obtained from the measurements and questionnaire responses.

Future plans

Insights emerging from the RECHS study can provide researchers and public health policy administrators with evidence to aid in the prevention of non-communicable diseases and clarify the most malleable status to implement preventive measures.

Nursing core competencies for postresuscitation care in Iran: a qualitative study

Por: Zali · M. · Rahmani · A. · Powers · K. · Hassankhani · H. · Namdar-Areshtanab · H. · Gilani · N.
Objective

This study explored nurses’ perceptions of the core competencies required for providing postresuscitation care in both in-hospital and out-of-hospital cardiac arrest.

Design

Qualitative conventional content analysis.

Participants

17 nurses selected with purposeful sampling method.

Setting

Three educational hospitals in northwest of Iran.

Data collection and analysis

Semi-structured interviews were used for data collection and they were analysed using conventional content analysis.

Results

Seven main categories have emerged from the data. The core competencies for nurses providing postresuscitation were identified as: quality assurance, providing evidence-based care, monitoring and presence, situation management, professionalism, positive attitude and providing family centred care.

Conclusions

The postresuscitation period is a unique and critical time requiring highly competent nursing care. Several core competencies for providing high-quality nursing care during postresuscitation period were identified through nurses’ experience in caring for patients postresuscitation.

What works, how and in which contexts when supporting parents to implement intensive speech and language therapy at home for children with speech sound disorder? A protocol for a realist review

Por: Leafe · N. · Pagnamenta · E. · Taggart · L. · Donnelly · M. · Hassiotis · A. · Titterington · J.
Introduction

Speech and language therapists (SLTs) worldwide report challenges with providing recommended, evidence-based intervention intensity for children with speech sound disorder (SSD). Challenges such as service constraints and/or family contexts impact on access to optimal therapy intensity. Existing research indicates that empowering and training parents to deliver intervention at home, alongside SLT support, offers one possible solution to increasing the intensity of intervention children with SSD receive. Digital health could increase accessibility to intensive home practice and help sustain engagement with therapy activities. Further exploration is needed around what makes parent-implemented interventions for children with SSD effective, for who and in which situations. This paper outlines the protocol for a realist review which aims to explore the active ingredients and contextual factors of effective digital parent-led interventions.

Methods and analysis

A realist review will explore the research question, following six stages. The scope of the review will be determined, and initial programme theories will be developed about what works in digital parent-implemented interventions for SSD, for whom, how, why and in what circumstances. Relevant secondary data, identified through a formal search strategy, will be selected, appraised, analysed and synthesised using realist principles to test and further refine the initial programme theories. This process will develop refined underpinning explanatory theories which capture the interaction between contexts, mechanisms and outcomes of the intervention. An expert steering group will provide insight to inform explanatory theories, searches, and dissemination.

Ethics and dissemination

Ethical approval is not required for this review. The refined programme theories from the review will inform the next stages of a wider study. A subsequent realist evaluation will test and further refine theories with key stakeholders. Following this, the underpinning programme theory will be used to coproduce a digital tool, to support parents to deliver home intervention alongside SLT support.

Stakeholders perspectives on clinical trial acceptability and approach to consent within a limited timeframe: a mixed methods study

Por: Deja · E. · Donohue · C. · Semple · M. G. · Woolfall · K. · for the BESS Investigators · Semple · McNamara · Allen · Fowler · Barker · Peak · Miert · Best · Donohue · Jones · Moitt · Price · Williamson · Clark · Madsen · Dawson · Summers · Deja · Woolfall · Osaghae · Turner · Panchal
Objectives

The Bronchiolitis Endotracheal Surfactant Study (BESS) is a randomised controlled trial to determine the efficacy of endo-tracheal surfactant therapy for critically ill infants with bronchiolitis. To explore acceptability of BESS, including approach to consent within a limited time frame, we explored parent and staff experiences of trial involvement in the first two bronchiolitis seasons to inform subsequent trial conduct.

Design

A mixed-method embedded study involving a site staff survey, questionnaires and interviews with parents approached about BESS.

Setting

Fourteen UK paediatric intensive care units.

Participants

Of the 179 parents of children approached to take part in BESS, 75 parents (of 69 children) took part in the embedded study. Of these, 55/69 (78%) completed a questionnaire, and 15/69 (21%) were interviewed. Thirty-eight staff completed a questionnaire.

Results

Parents and staff found the trial acceptable. All constructs of the Adapted Theoretical Framework of Acceptability were met. Parents viewed surfactant as being low risk and hoped their child’s participation would help others in the future. Although parents supported research without prior consent in studies of time critical interventions, they believed there was sufficient time to consider this trial. Parents recommended that prospective informed consent should continue to be sought for BESS. Many felt that the time between the consent process and intervention being administered took too long and should be ‘streamlined’ to avoid delays in administration of trial interventions. Staff described how the training and trial processes worked well, yet patients were missed due to lack of staff to deliver the intervention, particularly at weekends.

Conclusion

Parents and staff supported BESS trial and highlighted aspects of the protocol, which should be refined, including a streamlined informed consent process. Findings will be useful to inform proportionate approaches to consent in future paediatric trials where there is a short timeframe for consent discussions.

Trial registration number

ISRCTN11746266.

Efficacy of cell-based immunotherapies on patients with glioma: an umbrella review of systematic reviews and meta-analysis protocol

Por: Nikoobakht · M. · Shamshiripour · P. · Mostafavi Zadeh · S. M. · Rahnama · M. · Hajiahmadi · F. · Ramezani · A. · Farzam Rad · V. · Nazari · E. · Moradi · A.-R. · Akbarpour · M. · Ahmadvand · D.
Introduction

Glial brain tumours are highly mortal and are noted as major neurosurgical challenges due to frequent recurrence or progression. Despite standard-of-care treatment for gliomas, the prognosis of patients with higher-grade glial tumours is still poor, and hence empowering antitumour immunity against glioma is a potential future oncological prospect. This review is designed to improve our understanding of the efficacy of cell-based immunotherapies for glioma.

Methods and analysis

This systematic review will be performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A comprehensive search of main electronic databases: PubMed/MEDLINE, Scopus, ISI Web of Science EMBASE and ProQuest will be done on original articles, followed by a manual review of review articles. Only records in English and only clinical trials will be encountered for full-text review. All the appropriate studies that encountered the inclusion criteria will be screened, selected and then will undergo data extraction step by two independent authors. For meta-analyses, data heterogeneity for each parameter will be first evaluated by Cochran’s Q and I2 statistics. In case of possible heterogeneity, a random-effects meta-analysis will be performed and for homogenous data, fixed-effects models will be selected for reporting the results of the proportional meta-analysis. Bias risk will be assessed through Begg’s and Egger’s tests and will also be visualised by Funnel plots.

Ethics and dissemination

As this study will be a systematic review without human participants’ involvement, no ethical registration is required and meta-analysis will be presented at a peer-reviewed journal.

PROSPERO registration number

CRD42022373297

A novel, multidomain, primary care nurse-led and mHealth-assisted intervention for dementia risk reduction in middle-aged adults (HAPPI MIND): study protocol for a cluster randomised controlled trial

Por: Cross · A. J. · Geethadevi · G. M. · Magin · P. · Baker · A. L. · Bonevski · B. · Godbee · K. · Ward · S. A. · Mahal · A. · Versace · V. · Bell · J. S. · Mc Namara · K. · O'Reilly · S. L. · Thomas · D. · Manias · E. · Anstey · K. J. · Varnfield · M. · Jayasena · R. · Elliott · R. A. · Lee
Introduction

Middle-aged multidomain risk reduction interventions targeting modifiable risk factors for dementia may delay or prevent a third of dementia cases in later life. We describe the protocol of a cluster randomised controlled trial (cRCT), HAPPI MIND (Holistic Approach in Primary care for PreventIng Memory Impairment aNd Dementia). HAPPI MIND will evaluate the efficacy of a multidomain, nurse-led, mHealth supported intervention for assessing dementia risk and reducing associated risk factors in middle-aged adults in the Australian primary care setting.

Methods and analysis

General practice clinics (n≥26) across Victoria and New South Wales, Australia, will be recruited and randomised. Practice nurses will be trained to implement the HAPPI MIND intervention or a brief intervention. Patients of participating practices aged 45–65 years with ≥2 potential dementia risk factors will be identified and recruited (approximately 15 patients/clinic). Brief intervention participants receive a personalised report outlining their risk factors for dementia based on Australian National University Alzheimer’s Disease Risk Index (ANU-ADRI) scores, education booklet and referral to their general practitioner as appropriate. HAPPI MIND participants receive the brief intervention as well as six individualised dementia risk reduction sessions with a nurse trained in motivational interviewing and principles of behaviour change, a personalised risk reduction action plan and access to the purpose-built HAPPI MIND smartphone app for risk factor self-management. Follow-up data collection will occur at 12, 24 and 36 months. Primary outcome is ANU-ADRI score change at 12 months from baseline. Secondary outcomes include change in cognition, quality of life and individual risk factors of dementia.

Ethics and dissemination

Project approved by Monash University Human Research Ethics Committee (ID: 28273). Results will be disseminated in peer-reviewed journals and at healthcare conferences. If effective in reducing dementia risk, the HAPPI MIND intervention could be integrated into primary care, scaled up nationally and sustained over time.

Trial registration number

ACTRN12621001168842.

Comparing the long-term outcomes in chronic coronary syndrome patients with prior ST-segment and non-ST-segment elevation myocardial infarction: findings from the TIGRIS registry

Por: Krishnamurthy · S. N. · Pocock · S. · Kaul · P. · Owen · R. · Goodman · S. G. · Granger · C. B. · Nicolau · J. C. · Simon · T. · Westermann · D. · Yasuda · S. · Andersson · K. · Brandrup-Wognsen · G. · Hunt · P. R. · Brieger · D. B. · Cohen · M. G.
Objectives

Compared with ST-segment elevation myocardial infarction (STEMI) patients, non-STEMI (NSTEMI) patients have more comorbidities and extensive coronary artery disease. Contemporary comparative data on the long-term prognosis of stable post-myocardial infarction subtypes are needed.

Design

Long-Term rIsk, clinical manaGement and healthcare Resource utilisation of stable coronary artery dISease (TIGRIS) was a multinational, observational and longitudinal cohort study.

Setting

Patients were enrolled from 350 centres, with >95% coming from cardiology practices across 24 countries, from 19 June 2013 to 31 March 2017.

Participants

This study enrolled 8277 stable patients 1–3 years after myocardial infarction with ≥1 additional risk factor.

Outcome measures

Over a 2 year follow-up, cardiovascular events and deaths and self-reported health using the EuroQol 5-dimension questionnaire score were recorded. Relative risk of clinical events and health resource utilisation in STEMI and NSTEMI patients were compared using multivariable Poisson regression models, adjusting for prognostically relevant patient factors.

Results

Of 7752 patients with known myocardial infarction type, 46% had NSTEMI; NSTEMI patients were older with more comorbidities than STEMI patients. NSTEMI patients had significantly poorer self-reported health and lower prevalence of dual antiplatelet therapy at hospital discharge and at enrolment 1–3 years later. NSTEMI patients had a higher incidence of combined myocardial infarction, stroke and cardiovascular death (5.6% vs 3.9%, p

Conclusions

Post-NSTEMI chronic coronary syndrome patients had a less favourable risk factor profile, poorer self-reported health and more adverse cardiovascular events during long-term follow-up than individuals post STEMI. Efforts are needed to recognise the risks of stable patients after NSTEMI and optimise secondary prevention and care.

Trial registration number

NCT01866904.

Trends in the treatment of fibromyalgia in South Korea between 2011 and 2018: a retrospective analysis of cross-sectional health insurance data

Por: Yu · J.-S. · Kim · E.-S. · Park · K. S. · Lee · Y. J. · Park · Y. C. · Nam · D. · Kim · E.-J. · Ha · I.-H.
Objectives

Fibromyalgia treatment trends vary globally; however, the trend in South Korea has not been investigated yet. This study aimed to analyse the fibromyalgia treatment trends in South Korea.

Design

Retrospective, observational study using serial cross-sectional data.

Setting

The National Patient Samples of the Korean Health Insurance Review & Assessment Service from 2011 to 2018 were used.

Participants

A total of 31 059 patients with fibromyalgia were included in this study. The basic characteristics of the patients were stratified by sex, age and comorbidity. A patient was considered to have a condition if it was recorded as a principal diagnosis at least once in a year.

Primary and secondary outcome measures

Trends in the types of medical visits and prescribed treatments were investigated and the values are presented as rates per 100 patients. The types of pharmacological treatment were presented according to the existing clinical guidelines. Additionally, combination prescription trends and associated characteristics were investigated.

Results

Of the patients, 66.2% were female. Visits to internal medicine departments showed the most significant increase (2011: 11.34; 2018: 21.99; p

Conclusions

Our findings provide basic reference data for the development and application of national guidelines for fibromyalgia.

Metformin in the prevention of type 2 diabetes after gestational diabetes in postnatal women (OMAhA): a UK multicentre randomised, placebo-controlled, double-blind feasibility trial with nested qualitative study

Por: Bolou · A. · Drymoussi · Z. · Lanz · D. · Amaefule · C. E. · Gonzalez Carreras · F. J. · Pardo Llorente · M. d. C. · Dodds · J. · Pizzo · E. · Thomas · A. · Heighway · J. · Harden · A. · Sanghi · A. · Hitman · G. · Zamora · J. · Perez · T. · Huda · M. S. B. · Thangaratinam · S.
Objective

To determine the feasibility of a definitive trial of metformin to prevent type 2 diabetes in the postnatal period in women with gestational diabetes.

Design

A multicentre, placebo-controlled, double-blind randomised feasibility trial with qualitative evaluation.

Setting

Three inner-city UK National Health Service hospitals in London.

Participants

Pregnant women with gestational diabetes treated with medication.

Interventions

2 g of metformin (intervention) or placebo (control) from delivery until 1 year postnatally.

Primary outcome measures

Rates of recruitment, randomisation, follow-up, attrition and adherence to the intervention.

Secondary outcome measures

Preliminary estimates of glycaemic effects, qualitative exploration, acceptability of the intervention and costs.

Results

Out of 302 eligible women, 57.9% (175/302) were recruited. We randomised 82.3% (144/175) of those recruited, with 71 women in the metformin group and 73 women in the placebo group. Of the participants remaining in the study and providing any adherence information, 54.1% (59/109) took at least 75% of the target intervention dose; the overall mean adherence was 64% (SD 33.6). Study procedures were found to be acceptable to women and healthcare professionals. An increased perceived risk of developing type 2 diabetes, or a positive experience of taking metformin during pregnancy, encouraged participation and adherence to the intervention. Barriers to adherence included disruption to the medication schedule caused by the washout periods ahead of each study visit or having insufficient daily reminders.

Conclusions

It is feasible to run a full-scale definitive trial on the effectiveness of metformin to prevent type 2 diabetes in women with gestational diabetes, during the early postnatal period. Adherence and engagement with the study could be improved with more regular reminders and potentially the addition of ongoing educational or peer support to reinforce messages around type 2 diabetes prevention.

Trial registration number

ISRCTN20930880.

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