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AnteayerBMJ Open

MISSION ABC: transforming respiratory care through one-stop multidisciplinary clinics - an observational study

Por: Heiden · E. · Longstaff · J. · Chauhan · M. J. A. · DeVos · R. · Lanning · E. · Neville · D. · Jones · T. L. · Begum · S. · Amos · M. · Mottershaw · M. · Micklam · J. · Holdsworth · B. · Rupani · H. · Brown · T. · Chauhan · A. J. · Mission ABC Collaborators · Baghammar · Bannell · Domin
Objectives

The Modern Innovative Solutions to Improve Outcomes in Asthma, Breathlessness and Chronic Obstructive Pulmonary Disease (COPD) (MABC) service aimed to enhance disease management for chronic respiratory conditions through specialist multidisciplinary clinics, predominantly in the community. This study assesses the outcomes of these clinics.

Design

This study used a prospective, longitudinal, participatory action research approach.

Setting

The study was conducted in primary care practices across Hampshire, UK.

Participants

Adults aged 16 years and above with poorly controlled asthma or COPD, as well as those with undifferentiated breathlessness not under specialist care, were included.

Interventions

Participants received care through the multidisciplinary, specialist-led MABC clinics.

Primary and secondary outcome measures

Primary outcomes included disease activity, quality of life and healthcare utilisation. Secondary outcomes encompassed clinic attendance, diagnostic changes, patient activation, participant and healthcare professional experiences and cost-effectiveness.

Results

A total of 441 participants from 11 general practitioner practices were recruited. Ninety-six per cent of participants would recommend MABC clinics. MABC assessments led to diagnosis changes for 64 (17%) participants with asthma and COPD and treatment adjustments for 252 participants (57%). Exacerbations decreased significantly from 236 to 30 after attending the clinics (p

Conclusions

Specialist-supported multidisciplinary teams in MABC clinics improved diagnosis accuracy and adherence to guidelines. High patient satisfaction, disease control improvements and reduced exacerbations resulted in decreased unscheduled healthcare use and cost savings.

Trial registration number

NCT03096509.

Social deprivation and exclusion in Parkinsons disease: a cross-sectional and longitudinal study

Por: Heimrich · K. G. · Schönenberg · A. · Prell · T.
Objective

To describe prevalence and associated factors of social deprivation in people with Parkinson’s disease (PwPD).

Design

Cross-sectional and longitudinal cohort study.

Setting

Data were taken from the Survey of Health, Ageing and Retirement in Europe (SHARE), a multidisciplinary, cross-national and longitudinal research project.

Participants

Community-dwelling adults from waves 5 (2013, n=66 188) and 6 (2015, n=68 186) of the SHARE dataset. After longitudinal analyses, participants in wave 5 can be retrospectively divided into the following three subgroups: PwPD at wave 5 (n=559), people newly reported PD from wave 5 to wave 6 (prodromal PD; n=215) and people without PD (n=46 737).

Outcome measures

The prevalence and associated factors of social deprivation in PD, its impact on quality of life (QoL) and its onset within the course of PD.

Results

PwPD had higher indices for material and social deprivation than non-PD participants, and 20% of PwPD were at risk of social exclusion. Social deprivation alone accounted for 35% and material deprivation for 21% of QoL variance and remained significant predictors of QoL after adjustment for cofactors. Social deprivation and risk of social exclusion were already increased in people with prodromal PD, and accordingly preceded PD diagnosis in wave 6.

Conclusions

For the treatment of PD, we should consider the impact of social deprivation and exclusion on QoL and their association with mental and physical functioning. However, the relevance of social deprivation as a prodromal phenomenon requires further investigation.

Concordance of shoulder symptoms and imaging findings: a protocol for the Finnish Imaging of Shoulder (FIMAGE) study

Por: Ibounig · T. · Buchbinder · R. · Sillanpää · N. · Rämö · L. · Toivonen · P. · Raatikainen · S. · Koskinen · S. · Härkänen · T. · Rissanen · H. · Czuba · T. · Paavola · M. · Jarvinen · T. · Taimela · S. · for the FIMAGE investigators · Björkenheim · Heliövaara · Kalsk
Introduction

Shoulder pain is a substantial medical and socioeconomic problem in most societies, affecting the ability to work or carry out leisure time activities as well as subsequently influencing physical and psychological well-being. According to a nationwide survey in Finland, 27% of the population reported shoulder pain within the last 30 days. In clinical practice, imaging findings of structural abnormalities are typically thought to explain symptoms, even though such findings are also prevalent in asymptomatic individuals, particularly with increasing age. Overall, there is a paucity of high-quality evidence on the prevalence, clinical relevance and prognosis of ‘abnormal’ imaging findings of the shoulder.

The aim of the Finnish Imaging of Shoulder (FIMAGE) study is fourfold: to assess (1) the prevalence of shoulder symptoms and the most common anatomical variants and imaging abnormalities of the shoulder; (2) the concordance between shoulder symptoms, function and imaging abnormalities; (3) the most important determinants of symptoms, function and imaging abnormalities; and (4) the course of shoulder complaints over 5 years.

Methods

The FIMAGE target population of 600 participants, aged 40–75 years, will be randomly selected from a nationally representative general population sample of 9922 individuals originally recruited for the Finnish Health 2000 Survey. On giving informed consent, the participants will be invited to a clinical visit that includes assessment of general health, shoulder symptoms, bilateral shoulder examination and imaging of both shoulders with plain radiography and MRI.

Ethics and dissemination

The study has been approved by the Institutional Review Board of the Helsinki and Uusimaa Hospital District. The findings will be published according to the Strengthening the Reporting of Observational Studies in Epidemiology criteria.

Trial registration number

NCT05641415.

External validation of the QCovid 2 and 3 risk prediction algorithms for risk of COVID-19 hospitalisation and mortality in adults: a national cohort study in Scotland

Por: Kerr · S. · Millington · T. · Rudan · I. · McCowan · C. · Tibble · H. · Jeffrey · K. · Fagbamigbe · A. F. · Simpson · C. R. · Robertson · C. · Hippisley-Cox · J. · Sheikh · A.
Objective

The QCovid 2 and 3 algorithms are risk prediction tools developed during the second wave of the COVID-19 pandemic that can be used to predict the risk of COVID-19 hospitalisation and mortality, taking vaccination status into account. In this study, we assess their performance in Scotland.

Methods

We used the Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 national data platform consisting of individual-level data for the population of Scotland (5.4 million residents). Primary care data were linked to reverse-transcription PCR virology testing, hospitalisation and mortality data. We assessed the discrimination and calibration of the QCovid 2 and 3 algorithms in predicting COVID-19 hospitalisations and deaths between 8 December 2020 and 15 June 2021.

Results

Our validation dataset comprised 465 058 individuals, aged 19–100. We found the following performance metrics (95% CIs) for QCovid 2 and 3: Harrell’s C 0.84 (0.82 to 0.86) for hospitalisation, and 0.92 (0.90 to 0.94) for death, observed-expected ratio of 0.24 for hospitalisation and 0.26 for death (ie, both the number of hospitalisations and the number of deaths were overestimated), and a Brier score of 0.0009 (0.00084 to 0.00096) for hospitalisation and 0.00036 (0.00032 to 0.0004) for death.

Conclusions

We found good discrimination of the QCovid 2 and 3 algorithms in Scotland, although performance was worse in higher age groups. Both the number of hospitalisations and the number of deaths were overestimated.

From intentions to practices: what drove people to get the COVID-19 vaccine? Findings from the French longitudinal socioepidemiological cohort survey

Por: Spire · A. · Sireyjol · A. · Bajos · N. · for the EpiCoV study group · for the EpiCov study group · Bajos · Warszawski · Baghein · Counil · Jusot · Lydie · Martin · Meyer · Raynaud · Rouquette · Pailhe · Pousson · Rahib · Sillard · Spire
Objective

In many countries, before COVID-19 vaccines became available, reluctance to get vaccinated was particularly prevalent among women, the most disadvantaged social groups and ethnoracial minorities, known to be at higher risk for the virus. Using a longitudinal perspective, we analyse the social determinants that are associated with the transition from attitudes towards vaccination to actual vaccination practices.

Design

Representative population-based prospective cohort.

Settings

From November 2020 to July 2021.

Participants

Adults included in the Epidemiology and Living Conditions (EpiCoV) cohort (n=86 701).

Main outcome measures

Attitudes towards vaccination in November 2020 before COVID-19 vaccines were available in France (in January 2021) and vaccination practices in July 2021.

Results

Among those who were initially reluctant in November 2020, the youngest, the poorest 10% (OR=0.68, 0.59–0.77), non-European immigrants (OR=0.72, 0.59–0.88) and descendants of non-European immigrants (OR=0.72, 0.61–0.86) were less likely to be vaccinated in July 2021, irrespective of trust in government and scientists. The same social factors were associated with non-vaccination among those who initially were undecided or who favoured vaccination.

Conclusion

Despite the fact that COVID-19 vaccines were relatively available and free of charge in France in July 2021, social inequalities in vaccination against the virus remained the same than those observed in vaccination reluctance in November 2020, before vaccines were available. While adjusting for trust, migration background, younger age and lower income were associated with lower vaccination uptake irrespective of initial intention. By neglecting to genuinely target specific groups that were initially reluctant to be vaccinated, vaccination policies contributed to strengthening pre-existing social inequalities around COVID-19 burden.

Impact of an Acceptance and Commitment Therapy programme on HbA1c, self-management and psychosocial factors in adults with type 1 diabetes and elevated HbA1c levels: a randomised controlled trial

Por: Wijk · I. · Amsberg · S. · Johansson · U.-B. · Livheim · F. · Toft · E. · Anderbro · T.
Objective

To evaluate the impact of an Acceptance and Commitment Therapy (ACT) programme, tailored for people living with type 1 diabetes, on glycated haemoglobin (HbA1c), self-management and psychosocial factors among individuals with HbA1c>60 mmol/mol compared with treatment as usual (TAU).

Setting

An endocrinologic clinic in Sweden.

Participants

In this randomised controlled trial, 81 individuals with type 1 diabetes, aged 18–70 years with HbA1c>60 mmol/mol, were randomly assigned to either an ACT group intervention or TAU. Exclusion criteria were: unable to speak Swedish, untreated or severe psychiatric disease, cortisone treatment, untreated thyroid disease and newly started insulin pump therapy. At the 2-year follow-up, HbA1c was measured in 26 individuals.

Intervention

The ACT programme comprised seven 2-hour sessions held over 14 weeks and focused on acceptance of stressful thoughts and emotions, and to promote value-based committed action.

Outcomes

The primary outcome was HbA1c, and the secondary outcomes were measures of depression, anxiety, general stress, fear of hypoglycaemia, diabetes distress, self-care activities, psychological flexibility (general and related to diabetes) and quality of life. The primary endpoint was HbA1c 2 years after the intervention programme. Linear mixed models were used to test for an interaction effect between measurement time and group.

Results

Likelihood ratio test of nested models demonstrated no statistically significant interaction effect (2=0.49, p=0.485) between measurement time and group regarding HbA1c. However, a statistically significant interaction effect (likelihood ratio test 2=12.63, p

Conclusions

No statistically significant difference was found between the groups regarding the primary outcome measure, HbA1c. However, the ACT programme showed a persistent beneficial impact on psychological flexibility in the intervention group. The dropout rate was higher than expected, which may indicate a challenge in this type of study.

Trial registration number

NCT02914496.

Family-focused intervention to promote adolescent mental health and well-being in Moldova and North Macedonia (FLOURISH): feasibility study protocol

Por: Shenderovich · Y. · Piolanti · A. · Babii · V. · Calovska-Hertzog · N. · Evans · R. E. · Heinrichs · N. · Burgund Isakov · A. · Lesco · G. · Moore · G. · Mueller · J. · Raleva · M. · Shimbov · B. · Simon · J. · Waller · F. · Wienand · D. · Foran · H. M.
Introduction

Family-Focused Adolescent & Lifelong Health Promotion (FLOURISH) project will adapt, implement and evaluate a programme to support adolescent mental health and well-being through strategies, such as strengthening parenting practices, adolescent-caregiver relationships, adolescent and parent socioemotional skills, and social support.

Methods and analysis

The project will focus on adolescents aged 10–14 years and their caregivers in North Macedonia and Moldova. The countries were selected based on implementation readiness of two organisations and a need for accessible evidence-informed services to help mitigate health risks due to economic, social and political challenges. Parenting for Lifelong Health (PLH) for Parents and Teens is a family-based programme developed for low-resource settings. PLH has been adapted with input from advisory groups. The programme includes additional components to strengthen impacts on adolescents: adolescent mental health tools, based on UNICEF’s Helping Adolescents Thrive, adolescent peer support and participation booster. This pilot is first of three study phases. The pilot will be a feasibility testing of the adapted intervention and the assessment and implementation procedures to determine further refinements. The pilot will examine if the adapted programme is acceptable for adolescents, their families and providers, explore contextual factors relevant to embedding this programme into longer-term scale-up and investigate whether the programme can be delivered with fidelity and participation; whether the participants report changes in adolescent emotional and behavioural problems, well-being and other outcomes; and whether the study tools are feasible and appropriate. Pre-post adolescent and caregiver questionnaires will provide outcome data. Process evaluation will include attendance and fidelity data, and focus groups. We will examine delivery cost and resource requirements.

Ethics and dissemination

The study was approved at the University of Klagenfurt (Austria), Medical Faculty at St. Cyril and Methodius University (North Macedonia) and National Committee of Ethical Expertise for Clinical Trials (Moldova). Through stakeholder engagement and dissemination, FLOURISH will advance scale-up of open-source family interventions.

Trial registration number

Trial registration: ID101095528; project page: https://www.flourish-study.org/about.html; https://www.linkedin.com/company/flourish-study/

Cohort profile: evaluation of immune response and household transmission of SARS-CoV-2 in Costa Rica: the RESPIRA study

Por: Loria · V. · Aparicio · A. · Hildesheim · A. · Cortes · B. · Barrientos · G. · Retana · D. · Sun · K. · Ocampo · R. · Prevots · D. R. · Zuniga · M. · Waterboer · T. · Wong-McClure · R. · Morera · M. · Butt · J. · Binder · M. · Abdelnour · A. · Calderon · A. · Gail · M. H. · Pfeiffer · R. M.
Purpose

The RESPIRA cohort aims to describe the nature, magnitude, time course and efficacy of the immune response to SARS-CoV-2 infection and vaccination, population prevalence, and household transmission of COVID-19.

Participants

From November 2020, we selected age-stratified random samples of COVID-19 cases from Costa Rica confirmed by PCR. For each case, two population-based controls, matched on age, sex and census tract were recruited, supplemented with hospitalised cases and household contacts. Participants were interviewed and blood and saliva collected for antibodies and PCR tests. Participants will be followed for 2 years to assess antibody response and infection incidence.

Findings to date

Recruitment included 3860 individuals: 1150 COVID-19 cases, 1999 population controls and 719 household contacts from 304 index cases. The age and regional distribution of cases was as planned, including four age strata, 30% rural and 70% urban. The control cohort had similar sex, age and regional distribution as the cases according to the study design. Among the 1999 controls recruited, 6.8% reported at enrolment having had COVID-19 and an additional 12.5% had antibodies against SARS-CoV-2. Compliance with visits and specimens has been close to 70% during the first 18 months of follow-up. During the study, national vaccination was implemented and nearly 90% of our cohort participants were vaccinated during follow-up.

Future plans

RESPIRA will enable multiple analyses, including population prevalence of infection, clinical, behavioural, immunological and genetic risk factors for SARS-CoV-2 acquisition and severity, and determinants of household transmission. We are conducting retrospective and prospective assessment of antibody levels, their determinants and their protective efficacy after infection and vaccination, the impact of long-COVID and a series of ancillary studies. Follow-up continues with bimonthly saliva collection for PCR testing and biannual blood collection for immune response analyses. Follow-up will be completed in early 2024.

Trial registration number

NCT04537338.

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.

PAKistan Study of prEmature coronary atHerosclerosis in young AdulTs (PAK-SEHAT): a prospective longitudinal study protocol investigating the prevalence, severity and determinants of atherosclerotic cardiovascular disease in the young adult Pakistani popu

Por: Hanif · B. · Sheikh · S. · Peerwani · G. · Cainzos-Achirica · M. · Javed · W. · Baqar · J. B. · Samad · Z. · Bashir · F. · S Virani · S. · Nasir · K. · Aijaz · S.
Introduction

Atherosclerotic cardiovascular disease (ASCVD) is a major cause of morbidity, mortality and health expenditures worldwide. Despite having higher ASCVD in the Pakistani population, data on subclinical coronary atherosclerosis in young Pakistanis remain scarce. The PAKistan Study of prEmature coronary atHerosclerosis in young AdulTs (PAK-SEHAT) aims to assess the prevalence, severity and determinants of subclinical coronary atherosclerosis among Pakistani men (35–60 years) and women (35–65 years) free of clinically symptomatic ASCVD and will assess 5-year rates of ASCVD events.

Methods and analysis

PAK-SEHAT is an ongoing prospective cohort study with 2000 participants from all provinces of Pakistan who will be interviewed at the baseline along with phlebotomy, measurement of carotid intima-media thickness (CIMT) and coronary CT angiography (CCTA). Phlebotomy will be repeated at 2.5 years, whereas CIMT and CCTA will be repeated at 5 years. We will report the frequency of maximal coronary stenosis ≥50% and ≥70%, number of coronary vessels with plaque and the number of coronary segments affected per participant on CCTA. We will use Cox proportional hazards regression models to evaluate the association between baseline characteristics and incident ASCVD events during follow-up. These associations will be presented as HRs with 95% CIs.

Ethics and dissemination

The study protocol was approved by the Tabba Heart Institute Institutional Review Board (THI/IRB/FQ/22-09-2021/016). All study procedures are consistent with the principles of the Declaration of Helsinki. Findings of the study will be disseminated via peer-reviewed publications and conference presentations.

Trial registration number

NCT05156736.

Relationship between self-reported listening and communication difficulties and executive function: a protocol for a systematic review and meta-analysis

Por: Stacey · J. E. · Danielsson · H. · Heinrich · A. · Batinovic · L. · Holmer · E. · Ingo · E. · Henshaw · H.
Introduction

Listening and communication difficulties can limit people’s participation in activity and adversely affect their quality of life. Hearing, as well as listening and communication difficulties, can be measured either by using behavioural tests or self-report measures, and the outcomes are not always closely linked. The association between behaviourally measured and self-reported hearing is strong, whereas the association between behavioural and self-reported measures of listening and communication difficulties is much weaker, suggesting they assess different aspects of listening. While behavioural measures of listening and communication difficulties have been associated with poorer cognitive performance including executive functions, the same association has not always been shown for self-report measures. The objective of this systematic review and meta-analysis is to understand the relationship between executive function and self-reported listening and communication difficulties in adults with hearing loss, and where possible, potential covariates of age and pure-tone audiometric thresholds.

Methods and analysis

Studies will be eligible for inclusion if they report data from both a self-report measure of listening difficulties and a behavioural measure of executive function. Eight databases are to be searched: MEDLINE (via Ovid SP), EMBASE (via Ovid SP), PsycINFO (via Ovid SP), ASSIA (via ProQuest), Cumulative Index to Nursing and Allied Health Literature or CINAHL (via EBSCO Host), Scopus, PubMed and Web of Science (Science and Social Science Citation Index). The JBI critical appraisal tool will be used to assess risk of bias for included studies. Results will be synthesised primarily using a meta-analysis, and where sufficient quantitative data are not available, a narrative synthesis will be carried out to describe key results.

Ethics and dissemination

No ethical issues are foreseen. Data will be disseminated via academic publication and conference presentations. Findings may also be published in scientific newsletters and magazines.

PROSPERO registration number

CRD42022293546.

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