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☐ ☆ ✇ BMJ Open

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 — Diciembre 22nd 2023 at 17:32
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.

☐ ☆ ✇ BMJ Open

Behavioural and social drivers of COVID-19 vaccination in Vietnam: a scoping review

Por: Tran · L. · Dang · T. · Nguyen · M. · Kaufman · J. · Overmars · I. · Shrestha · S. · Abdi · I. · Nguyen · T. · Marahajan · M. · Chu · T. · Danchin · M. · Fox · G. · Nguyen · T. A. — Diciembre 22nd 2023 at 04:36
Background

Understanding of the behavioural and social drivers (BeSD) of vaccination is key to addressing vaccine hesitancy and accessibility issues. Vietnam’s national COVID-19 vaccination programme resulted in high uptake of primary doses among adults, but lower booster doses for adults and primary doses for 5–11 years. This scoping review assessed BeSD influencing COVID-19 vaccine uptake in Vietnam to design interventions on reaching the national vaccination targets.

Method

We conducted a scoping review by searching PubMed, MedRxiv, LitCOVID, COVID-19 LOVE platform, WHO’s COVID-19 research database and seven dominant Vietnamese language medical journals published in English or Vietnamese between 28 December 2019 and 28 November 2022. Data were narratively synthesised and summarised according to the four components of the WHO BeSD framework. The drivers were then mapped along the timeline of COVID-19 vaccine deployment and the evolution of the pandemic in Vietnam.

Results

We identified 680 records, of which 39 met the inclusion criteria comprising 224 204 participants. Adults’ intention to receive COVID-19 vaccines for themselves (23 studies) ranged from 58.0% to 98.1%. Parental intention to vaccinate their under 11-year-old children (six studies) ranged from 32.8% to 79.6%. Key drivers of vaccination uptake were perceived susceptibility and severity of disease, perceived vaccine benefits and safety, healthcare worker recommendation, and positive societal perception. Commonly reported COVID-19 vaccines’ information sources (six studies) were social and mainstream media (82%–67%), television (72.7%–51.6%) and healthcare workers (47.5%–17.5%). Key drivers of COVID-19 uptake remained consistent for both adults and children despite changes in community transmission and vaccine deployment.

Conclusion

Key enablers of vaccine uptake for adults and children included perceived disease severity, perceived vaccine benefits and safety and healthcare worker recommendations. Future studies should assess vaccine communication targeted to these drivers, national policies and political determinants to optimise vaccine uptake.

☐ ☆ ✇ BMJ Open

Analysis of maternal and child health spillover effects in PEPFAR countries

Por: Gaumer · G. · Crown · W. H. · Kates · J. · Luan · Y. · Hariharan · D. · Jordan · M. · Hurley · C. L. · Nandakumar · A. — Diciembre 22nd 2023 at 04:36
Objectives

This study examined whether the US President’s Emergency Plan for AIDS Relief (PEPFAR) funding had effects beyond HIV, specifically on several measures of maternal and child health in low-income and middle-income countries (LMICs). The results of previous research on the question of PEPFAR health spillovers have been inconsistent. This study, using a large, multicountry panel data set of 157 LMICs including 90 recipient countries, adds to the literature.

Design

Seven indicators including child and maternal mortality, several child vaccination rates and anaemia among childbearing-age women are important population health indicators. Panel data and difference-in-differences estimators (DID) were used to estimate the impact of the PEPFAR programme from inception in 2004 to 2018 using a comparison group of 67 LMICs. Several different models of baseline (2004) covariates were used to help balance the comparison and treatment groups. Staggered DID was used to estimate impacts since all countries did not start receiving aid at PEPFAR’s inception.

Setting

All 157 LMICs from 1990 to 2018.

Participants

90 LMICs receiving PEPFAR aid and cohorts of those countries, including those required to submit annual country operational plans (COP), other recipient countries (non-COP), and three groupings of countries based on cumulative amount of per capita aid received (high, medium, low).

Interventions

PEPFAR aid to combat the HIV epidemic.

Primary outcome measures

Maternal mortality and child mortality rates, vaccination rates to protect children for diphtheria, whooping cough and tetanus, measles, HepB3, and tetanus, and prevalence of anaemia in women of childbearing age.

Results

Across PEPFAR recipient countries, large, favourable PEPFAR health effects were found for rates of childhood immunisation, child mortality and maternal mortality. These beneficial health effects were large and significant in all segments of PEPFAR recipient countries studied. We also found significant and favourable programme effects on the prevalence of anaemia in women of childbearing age in PEPFAR recipient countries receiving the most intensive financial support from the PEPFAR programme. Other recipient countries did not demonstrate significant effects on anaemia.

Conclusions

This study demonstrated that important health indicators, beyond HIV, have been consistently and favourably influenced by PEPFAR presence. Child and maternal mortality have been substantially reduced, and childhood immunisation rates increased. We also found no evidence of ‘crowding out’ or negative spillovers in these resource-poor countries. These findings add to the body of evidence that PEPFAR has had favourable health effects beyond HIV. The implications of these findings are that foreign aid for health in one area may have favourable health effects in other areas in recipient countries. More research is needed on the influence of the mechanisms at work that create these spillover health effects of PEPFAR.

☐ ☆ ✇ BMJ Open

Faith-based organisations and their role in supporting vaccine confidence and uptake: a scoping review protocol

Por: Song · M. Y. · Blake-Hepburn · D. · Fadel · S. · Allin · S. · Ataullahjan · A. · Di Ruggiero · E. — Diciembre 22nd 2023 at 04:36
Introduction

Faith-based organisations (FBOs) and religious actors increase vaccine confidence and uptake among ethnoracially minoritised communities in low-income and middle-income countries. During the COVID-19 pandemic and the subsequent vaccine rollout, global organisations such as the WHO and UNICEF called for faith-based collaborations with public health agencies (PHAs). As PHA-FBO partnerships emerge to support vaccine uptake, the scoping review aims to: (1) outline intervention typologies and implementation frameworks guiding interventions; (2) describe the roles of PHAs and FBOs in the design, implementation and evaluation of strategies and (3) synthesise outcomes and evaluations of PHA-FBO vaccine uptake initiatives for ethnoracially minoritised communities.

Methods and analysis

We will perform six library database searches in PROQUEST-Public Health, OVID MEDLINE, Cochrane Library, CINAHL, SCOPUS- all, PROQUEST - Policy File index; three theses repositories, four website searches, five niche journals and 11 document repositories for public health. These databases will be searched for literature that describe partnerships for vaccine confidence and uptake for ethnoracially minoritised populations, involving at least one PHA and one FBO, published in English from January 2011 to October 2023. Two reviewers will pilot-test 20 articles to refine and finalise the inclusion/exclusion criteria and data extraction template. Four reviewers will independently screen and extract the included full-text articles. An implementation science process framework outlining the design, implementation and evaluation of the interventions will be used to capture the array of partnerships and effectiveness of PHA-FBO vaccine uptake initiatives.

Ethics and dissemination

This multiphase Canadian Institutes of Health Research (CIHR) project received ethics approval from the University of Toronto. Findings will be translated into a series of written materials for dissemination to CIHR, and collaborating knowledge users (ie, regional and provincial PHAs), and panel presentations at conferences to inform the development of a best-practices framework for increasing vaccine confidence and uptake.

☐ ☆ ✇ BMJ Open

Long COVID in long-term care: a rapid realist review

Por: Fyffe · I. · Sorensen · J. · Carroll · S. · MacPhee · M. · Andrews-Paul · A. · Crooks · V. A. · Freeman · S. · Davison · K. · Walls · J. · Berndt · A. · Shams · B. · Sivan · M. · Mithani · A. — Diciembre 21st 2023 at 06:07
Objectives

The goals of this rapid realist review were to ask: (a) what are the key mechanisms that drive successful interventions for long COVID in long-term care (LTC) and (b) what are the critical contexts that determine whether the mechanisms produce the intended outcomes?

Design

Rapid realist review.

Data sources

Medline, CINAHL, Embase, PsycINFO and Web of Science for peer-reviewed literature and Google for grey literature were searched up to 23 February 2023.

Eligibility criteria

We included sources focused on interventions, persons in LTC, long COVID or post-acute phase at least 4 weeks following initial COVID-19 infection and ones that had a connection with source materials.

Data extraction and synthesis

Three independent reviewers searched, screened and coded studies. Two independent moderators resolved conflicts. A data extraction tool organised relevant data into context-mechanism-outcome configurations using realist methodology. Twenty-one sources provided 51 intervention data excerpts used to develop our programme theory. Synthesised findings were presented to a reference group and expert panel for confirmatory purposes.

Results

Fifteen peer-reviewed articles and six grey literature sources were eligible for inclusion. Eleven context-mechanism-outcome configurations identify those contextual factors and underlying mechanisms associated with desired outcomes, such as clinical care processes and policies that ensure timely access to requisite resources for quality care delivery, and resident-centred assessments and care planning to address resident preferences and needs. The underlying mechanisms associated with enhanced outcomes for LTC long COVID survivors were: awareness, accountability, vigilance and empathetic listening.

Conclusions

Although the LTC sector struggles with organisational capacity issues, they should be aware that comprehensively assessing and monitoring COVID-19 survivors and providing timely interventions to those with long COVID is imperative. This is due to the greater care needs of residents with long COVID, and coordinated efficient care is required to optimise their quality of life.

☐ ☆ ✇ BMJ Open

Protection of the third-dose and fourth-dose mRNA vaccines against SARS-CoV-2 Omicron subvariant: a systematic review and meta-analysis

Por: Rahman · M. O. · Kamigaki · T. · Thandar · M. M. · Haruyama · R. · Yan · F. · Shibamura-Fujiogi · M. · Khin Maung Soe · J. · Islam · M. R. · Yoneoka · D. · Miyahara · R. · Ota · E. · Suzuki · M. — Diciembre 21st 2023 at 06:07
Objectives

The rapid spread of the SARS-CoV-2 Omicron variant has raised concerns regarding waning vaccine-induced immunity and durability. We evaluated protection of the third-dose and fourth-dose mRNA vaccines against SARS-CoV-2 Omicron subvariant and its sublineages.

Design

Systematic review and meta-analysis.

Data sources

Electronic databases and other resources (PubMed, Embase, CENTRAL, MEDLINE, CINAHL PLUS, APA PsycINFO, Web of Science, Scopus, ScienceDirect, MedRxiv and bioRxiv) were searched until December 2022.

Study eligibility criteria

We included studies that assessed the effectiveness of mRNA vaccine booster doses against SARS-CoV-2 infection and severe COVID-19 outcomes caused by the subvariant.

Data extraction and synthesis

Estimates of vaccine effectiveness (VE) at different time points after the third-dose and fourth-dose vaccination were extracted. Random-effects meta-analysis was used to compare VE of the third dose versus the primary series, no vaccination and the fourth dose at different time points. The certainty of the evidence was assessed by Grading of Recommendations, Assessments, Development and Evaluation approach.

Results

This review included 50 studies. The third-dose VE, compared with the primary series, against SARS-CoV-2 infection was 48.86% (95% CI 44.90% to 52.82%, low certainty) at ≥14 days, and gradually decreased to 38.01% (95% CI 13.90% to 62.13%, very low certainty) at ≥90 days after the third-dose vaccination. The fourth-dose VE peaked at 14–30 days (56.70% (95% CI 50.36% to 63.04%), moderate certainty), then quickly declined at 61–90 days (22% (95% CI 6.40% to 37.60%), low certainty). Compared with no vaccination, the third-dose VE was 75.84% (95% CI 40.56% to 111.12%, low certainty) against BA.1 infection, and 70.41% (95% CI 49.94% to 90.88%, low certainty) against BA.2 infection at ≥7 days after the third-dose vaccination. The third-dose VE against hospitalisation remained stable over time and maintained 79.30% (95% CI 58.65% to 99.94%, moderate certainty) at 91–120 days. The fourth-dose VE up to 60 days was 67.54% (95% CI 59.76% to 75.33%, moderate certainty) for hospitalisation and 77.88% (95% CI 72.55% to 83.21%, moderate certainty) for death.

Conclusion

The boosters provided substantial protection against severe COVID-19 outcomes for at least 6 months, although the duration of protection remains uncertain, suggesting the need for a booster dose within 6 months of the third-dose or fourth-dose vaccination. However, the certainty of evidence in our VE estimates varied from very low to moderate, indicating significant heterogeneity among studies that should be considered when interpreting the findings for public health policies.

PROSPERO registration number

CRD42023376698.

☐ ☆ ✇ BMJ Open

Examining the extent, forms and factors influencing multiple job holding among medical doctors, professional nurses and rehabilitation therapists in two South African provinces: a cross-sectional study

Por: Matiwane · B. P. · Blaauw · D. · Rispel · L. C. — Diciembre 21st 2023 at 06:07
Objective

Multiple job holding (MJH), or working in more than one paid job simultaneously, is a common characteristic of health labour markets. The study examined the extent (prevalence), forms and factors influencing MJH among public sector medical doctors, professional nurses and rehabilitation therapists in two South African provinces.

Design

A cross-sectional, analytical study.

Setting

29 public sector hospitals in the Gauteng and Mpumalanga provinces of South Africa.

Participants

Full-time public sector medical doctors, professional nurses and rehabilitation therapists.

Results

We obtained an overall response rate of 84.3%, with 486 medical doctors, 571 professional nurses and 340 rehabilitation therapists completing the survey. The mean age was 39.9±9.7 years for medical doctors, 43.7±10.4 years for professional nurses and 32.3±8.7 years for rehabilitation therapists. In the preceding 12 months, the prevalence of MJH was 33.7% (95% CI 25.8% to 42.6%) among medical doctors, 8.6% (95% CI 6.3% to 11.7%) among professional nurses and 38.7% (95% CI 31.5% to 46.5%) among rehabilitation therapists. Medical doctors worked a median of 20 (10–40) hours per month in their additional jobs, professional nurses worked 24 (12–34) hours per month and rehabilitation therapists worked 16 (8–28) hours per month. Private practice was the most prevalent form of MJH among medical doctors and rehabilitation therapists, compared with nursing agencies for professional nurses. MJH was significantly more likely among medical specialists (OR 4.3, p

Conclusion

The high prevalence of MJH could adversely affect the care of public sector patients. The study findings should inform the review and revision of existing MJH policies.

☐ ☆ ✇ BMJ Open

Childhood and adolescent factors shaping vulnerability to underage entry into sex work: a quantitative hierarchical analysis of female sex workers in Nairobi, Kenya

Por: Shah · P. · Kabuti · R. · Beksinska · A. · Nyariki · E. · Babu · H. · Kungu · M. · Jama · Z. · Ngurukiri · P. · The Maisha Fiti Study Champions · Kaul · R. · Kyegombe · N. · Medley · G. F. · Devries · K. · Seeley · J. · Weiss · H. A. · Beattie · T. S. · Kimani · J. · Gwala · Oside · Kamen — Diciembre 19th 2023 at 16:46
Objective

To explore factors associated with early age at entry into sex work, among a cohort of female sex workers (FSWs) in Nairobi, Kenya.

Background

Younger age at sex work initiation increases the risk of HIV acquisition, condom non-use, violence victimisation and alcohol and/or substance use problems. This study aimed to understand factors in childhood and adolescence that shape the vulnerability to underage sex work initiation.

Design

Building on previous qualitative research with this cohort, analysis of behavioural–biological cross-sectional data using hierarchical logistic regression.

Participants and measures

FSWs aged 18–45 years were randomly selected from seven Sex Workers Outreach Programme clinics in Nairobi, and between June and December 2019, completed a baseline behavioural–biological survey. Measurement tools included WHO Adverse Childhood Experiences, Alcohol, Smoking and Substance Involvement Screening Test and questionnaires on sociodemographic information, sexual risk behaviours and gender-based violence. Descriptive statistics and logistic regression were conducted using hierarchical modelling.

Results

Of the 1003 FSWs who participated in the baseline survey (response rate 96%), 176 (17.5%) initiated sex work while underage (

Conclusions

Lower education level and childhood homelessness, combined with sexual violence and sexual risk behaviours in childhood, create pathways to underage initiation into sex work. Interventions designed for girls and young women at these pivotal points in their lives could help prevent underage sex work initiation and their associated health, social and economic consequences.

☐ ☆ ✇ BMJ Open

Defining 'therapeutic value of medicines: a scoping review

Por: Glaus · C. E. G. · Kloeti · A. · Vokinger · K. N. — Diciembre 19th 2023 at 03:04
Objectives

In recent years, discussions on the importance and scope of therapeutic value of new medicines have intensified, stimulated by the increase of prices and number of medicines entering the market. This study aims to perform a scoping review identifying factors contributing to the definition of the therapeutic value of medicines.

Design

Scoping review.

Data sources

We searched the MEDLINE, CINAHL, Embase, Business Source Premier, EconLit, Regional Business News, Cochrane, Web of Science, Scope and Pool databases through December 2020 in English, German, French, Italian and Spanish.

Eligibility criteria

Studies that included determinants for the definition of therapeutic value of medicines were included.

Data extraction and synthesis

Data were extracted using the mentioned data sources. Two reviewers independently screened and analysed the articles. Data were analysed from April 2021 to May 2022.

Results

Of the 1883 studies screened, 51 were selected and the identified factors contributing to the definition of therapeutic value of medicines were classified in three categories: patient perspective, public health perspective and socioeconomic perspective. More than three-quarters of the included studies were published after 2014, with the majority of the studies focusing on either cancer disorders (14 of 51, 27.5%) or rare diseases (11 of 51, 21.6%). Frequently mentioned determinants for value were quality of life, therapeutic alternatives and side effects (all patient perspective), prevalence/incidence and clinical endpoints (all public health perspective), and costs (socioeconomic perspective).

Conclusions

Multiple determinants have been developed to define the therapeutic value of medicines, most of them focusing on cancer disorders and rare diseases. Considering the relevance of value of medicines to guide patients and physicians in decision-making as well as policymakers in resource allocation decisions, a development of evidence-based factors for the definition of therapeutic value of medicines is needed across all therapeutic areas.

☐ ☆ ✇ BMJ Open

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. — Diciembre 19th 2023 at 03:04
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.

☐ ☆ ✇ BMJ Open

Thirty-day hospital readmission predictors in older patients receiving hospital-at-home: a 3-year retrospective study in France

Por: de Stampa · M. · Georges · A. · Grino · M. · Cerase · V. · Baudouin · E. · Vedel · I. — Diciembre 19th 2023 at 03:04
Objective

This study described older patients receiving hospitalisation-at-home (HaH) services and identified factors associated with 30-day hospital readmission.

Design

3-year retrospective study in 2017–2019 in France.

Participants

75 108 patients aged 75 years and older who were discharged from hospital medical wards (internal medicine and geriatric units) and admitted to HaH.

Primary outcome measure

30-day hospital readmission.

Results

The mean age of patients was 83.4 years (SD 5.7), 52.3% were male and 88.4% lived in a private household. Patients were primarily discharged from the internal medicine unit (85.3%). The top four areas of care in the HaH were palliative care, complex dressing, intravenous therapy and complex nursing care. Overall, 23.5% of patients died during their HaH stay and 27.8% were readmitted to the hospital at 30 days. In the multivariate model, male (OR 1.19, 95% CI 1.16 to 1.23), supportive cancer HaH care (OR 1.78, 95% CI 1.51 to 2.11) and very high intensity care during the previous in-person hospitalisation (OR 1.45, 95% CI 1.34 to 1.57) increased the risk of hospital readmission at 30 days. Older age (OR 0.97, 95% CI 0.97 to 0.98), living in a nursing home (OR 0.51, 95% CI 0.48 to 0.54), postsurgery HaH care (OR 0.49, 95% CI 0.41 to 0.58) and having been previously hospitalised in a geriatric unit (OR 0.81, 95% CI 0.77 to 0.85) decreased the risk of hospital readmission at 30 days.

Conclusions

HaH provides complex care to very old patients, which is associated with high mortality. Several factors are associated with rehospitalisation within 30 days that could be avoided with better integration of different services with higher geriatric skills.

Trial registration number

CNIL:2228861.

☐ ☆ ✇ BMJ Open

Point-of-care haemoglobin accuracy and transfusion outcomes in non-cardiac surgery at a Canadian tertiary academic hospital: protocol for the PREMISE observational study

Por: Brousseau · K. · Monette · L. · McIsaac · D. I. · Workneh · A. · Tinmouth · A. · Shaw · J. · Ramsay · T. · Mallick · R. · Presseau · J. · Wherrett · C. · Carrier · F. M. · Fergusson · D. A. · Martel · G. — Diciembre 15th 2023 at 06:39
Introduction

Transfusions in surgery can be life-saving interventions, but inappropriate transfusions may lack clinical benefit and cause harm. Transfusion decision-making in surgery is complex and frequently informed by haemoglobin (Hgb) measurement in the operating room. Point-of-care testing for haemoglobin (POCT-Hgb) is increasingly relied on given its simplicity and rapid provision of results. POCT-Hgb devices lack adequate validation in the operative setting, particularly for Hgb values within the transfusion zone (60–100 g/L). This study aims to examine the accuracy of intraoperative POCT-Hgb instruments in non-cardiac surgery, and the association between POCT-Hgb measurements and transfusion decision-making.

Methods and analysis

PREMISE is an observational prospective method comparison study. Enrolment will occur when adult patients undergoing major non-cardiac surgery require POCT-Hgb, as determined by the treating team. Three concurrent POCT-Hgb results, considered as index tests, will be compared with a laboratory analysis of Hgb (lab-Hgb), considered the gold standard. Participants may have multiple POCT-Hgb measurements during surgery. The primary outcome is the difference in individual Hgb measurements between POCT-Hgb and lab-Hgb, primarily among measurements that are within the transfusion zone. Secondary outcomes include POCT-Hgb accuracy within the entire cohort, postoperative morbidity, mortality and transfusion rates. The sample size is 1750 POCT-Hgb measurements to obtain a minimum of 652 Hgb measurements

Ethics and dissemination

Institutional ethics approval has been obtained by the Ottawa Health Science Network—Research Ethics Board prior to initiating the study. Findings from this study will be published in peer-reviewed journals and presented at relevant scientific conferences. Social media will be leveraged to further disseminate the study results and engage with clinicians.

☐ ☆ ✇ BMJ Open

Implementing a complex mental health intervention in occupational settings: process evaluation of the MENTUPP pilot study

Por: Tsantila · F. · Coppens · E. · De Witte · H. · Arensman · E. · Aust · B. · Pashoja · A. C. · Corcoran · P. · Cully · G. · De Winter · L. · Doukani · A. · Dushaj · A. · Fanaj · N. · Griffin · E. · Hogg · B. · Holland · C. · Leduc · C. · Leduc · M. · Mathieu · S. · Maxwell · M. · Ni Dhalaigh — Diciembre 15th 2023 at 06:39
Background

According to the Medical Research Council (MRC) framework, the theorisation of how multilevel, multicomponent interventions work and the understanding of their interaction with their implementation context are necessary to be able to evaluate them beyond their complexity. More research is needed to provide good examples following this approach in order to produce evidence-based information on implementation practices.

Objectives

This article reports on the results of the process evaluation of a complex mental health intervention in small and medium enterprises (SMEs) tested through a pilot study. The overarching aim is to contribute to the evidence base related to the recruitment, engagement and implementation strategies of applied mental health interventions in the workplace.

Method

The Mental Health Promotion and Intervention in Occupational Settings (MENTUPP) intervention was pilot tested in 25 SMEs in three work sectors and nine countries. The evaluation strategy of the pilot test relied on a mixed-methods approach combining qualitative and quantitative research methods. The process evaluation was inspired by the RE-AIM framework and the taxonomy of implementation outcomes suggested by Proctor and colleagues and focused on seven dimensions: reach, adoption, implementation, acceptability, appropriateness, feasibility and maintenance.

Results

Factors facilitating implementation included the variety of the provided materials, the support provided by the research officers (ROs) and the existence of a structured plan for implementation, among others. Main barriers to implementation were the difficulty of talking about mental health, familiarisation with technology, difficulty in fitting the intervention into the daily routine and restrictions caused by COVID-19.

Conclusions

The results will be used to optimise the MENTUPP intervention and the theoretical framework that we developed to evaluate the causal mechanisms underlying MENTUPP. Conducting this systematic and comprehensive process evaluation contributes to the enhancement of the evidence base related to mental health interventions in the workplace and it can be used as a guide to overcome their contextual complexity.

Trial registration number

ISRCTN14582090.

☐ ☆ ✇ BMJ Open

Dimensions of suffering and the need for palliative care: experiences and expectations of patients living with cancer and diabetes and their caregivers in Mexico - a qualitative study

Por: Doubova · S. V. · Bhadelia · A. · Perez-Moran · D. · Martinez-Vega · I. P. · Garcia-Cervantes · N. · Knaul · F. — Diciembre 15th 2023 at 06:39
Objectives

Over 40 million people in low-income and middle-income countries (LMICs) experience serious health-related suffering (SHS) annually and require palliative care. Patient and caregiver experiences of SHS in LMICs are understudied despite their importance in guiding palliative care provision. Diabetes and cancer are the second-leading and third-leading causes of death in Mexico, causing a significant SHS burden on patients, families and health systems. This study examines SHS and palliative care from the point of view of patients with cancer and diabetes and their caregivers.

Design

A qualitative descriptive study based on in-depth telephone interviews was conducted between August 2021 and February 2022. Data were analysed through inductive thematic analysis.

Participants

Overall, 20 patients with end-stage cancer, 13 patients with diabetes and 35 family caregivers were interviewed individually.

Setting

Participants were recruited from two family medicine clinics and a pain clinic in Mexico City.

Results

Seven themes emerged: (1) suffering as a multifaceted phenomenon, (2) diversity in perceptions of suffering, (3) different coping strategies, (4) need and perceived importance of relief from suffering, (5) barriers to accessing services to relieve suffering, (6) demand for the health sector’s active and humane role in addressing suffering and (7) preferences and need for comprehensive care for relief from suffering. The primary coping strategies included family companionship, protective buffering and faith-based support. Participants lacked knowledge of palliative care. They expressed the importance of relief from suffering, viewing it as the health sector’s responsibility and requesting more humane, personalised care and access to medicines and pain clinics.

Conclusions

The multifaceted nature of SHS highlights the health system’s responsibility to provide high-quality palliative care. Policies to enhance access to palliative care should integrate it into primary care, redesigning services towards patient and caregiver biopsychosocial and spiritual needs and ensuring access to medicines and competent health personnel.

☐ ☆ ✇ BMJ Open

Observational and prospective study: evaluation of beliefs and representations of chronic treatments of polymedicated patients hospitalised in a vascular medicine and surgery department

Por: Kotry · D. · Saillard · J. · Bonsergent · M. · Volteau · C. · Benichou · A. · Prot-Labarthe · S. · Huon · J.-F. — Diciembre 14th 2023 at 04:03
Objectives

Today, the involvement of patients in their care is essential. As the population ages increases, the number of patients with chronic diseases is increasing. In the vascular medicine and surgery departments, patients are polymedicated and mostly suffer from several chronic diseases. Approximately 50% of patients with a chronic disease are not adherent. Among the factors that can influence therapeutic adherence are the beliefs and representations of patients.

To evaluate the beliefs and representations of chronic treatments in patients with multiple medications and hospitalised in a vascular medicine and surgery department, and to evaluate the medication adherence, the knowledge and the importance patients attach to their treatments.

Design

Observational, prospective and a single-centre study.

Setting

The study was conducted in a French tertiary hospital centre of around 3000 beds in 9 institutions.

Participants

Adult polymedicated (ie, minimum of five chronic treatments) patients hospitalised in a vascular medicine and surgery department were included after application of the exclusion criteria.

Methods

Patient interviews were carried out in the department and were based on three interviewer-administered questionnaires (a global questionnaire, the Belief Medical Questionnaire and the GIRERD questionnaire).

Results

Our study showed that patients perceived their treatments as beneficial rather than worrying. A correlation between medication adherence and beliefs was observed. ‘Non-adherent’patients had a more negative overall view of medication than ‘adherent’ patients. The level of compliance and knowledge of our patients was low. Only 11% of the patients were ‘good adherent’, 16% of the patients could perfectly name their treatment and 36% knew all the indications.

Conclusion

Knowledge of treatment representation and beliefs are central to understanding patient behaviour. Considering patients’ representations will allow the identification of levers, and the development of actions and educational tools adapted to improve their adherence, their knowledge and therefore their drug management.

☐ ☆ ✇ BMJ Open

Consensus building on definitions and types of child maltreatment to improve recording and surveillance in Europe: protocol for a multi-sectoral, European, electronic Delphi study

Por: Nurmatov · U. · Cowley · L. E. · Rodrigues · L. B. · Naughton · A. · Debelle · G. · Alfandari · R. · Lamela · D. · Otterman · G. · Jud · A. · Ntinapogias · A. · Laajasalo · T. · Soldino · V. · Stancheva · V. · Caenazzo · L. · Vaughan · R. · Christian · C. W. · Drabarek · K. · Kemp · A. M. — Diciembre 12th 2023 at 17:17
Introduction

Child maltreatment (CM) is a complex global public health issue with potentially devastating effects on individuals’ physical and mental health and well-being throughout the life course. A lack of uniform definitions hinders attempts to identify, measure, respond to, and prevent CM. The aim of this electronic Delphi (e-Delphi) study is to build consensus on definitions and types of CM for use in surveillance and multi-sectoral research in the 34 countries in the Euro-CAN (Multi-Sectoral Responses to Child Abuse and Neglect in Europe) project (COST Action CA19106).

Methods and analysis

The e-Delphi study will consist of a maximum of three rounds conducted using an online data collection platform. A multi-disciplinary expert panel consisting of researchers, child protection professionals (health and social care), police, legal professionals and adult survivors of CM will be purposefully recruited. We will approach approximately 100 experts, with between 50 and 60 of these anticipated to take part. Participants will rate their agreement with a range of statements relating to operational definitions and types of CM, and free-text comments on each of the statements to give further detail about their responses and areas of uncertainty. Consensus has been defined a priori as ≥70% of the panel agreeing or disagreeing with the statement after the final round. The responses to the open-ended questions will be analysed using a ‘codebook’ approach to thematic analysis, and used to refine the statements between rounds where no consensus is reached.

Ethics and dissemination

Ethical approval has been granted from the Cardiff University School of Medicine ethics committee (reference number SMREC22/96). Results will be submitted for publication in a peer-reviewed journal and presented at workshops (including for the participants) and international academic conferences. The Euro-CAN network will also be used to disseminate the results, with results briefings and presentations to key public health and other relevant organisations in the field.

☐ ☆ ✇ BMJ Open

Advancing Suicide Intervention Strategies for Teens (ASSIST): study protocol for a multisite randomised controlled trial

Por: Adrian · M. · McCauley · E. · Gallop · R. · Stevens · J. · Jobes · D. A. · Crumlish · J. · Stanley · B. · Brown · G. K. · Green · K. L. · Hughes · J. L. · Bridge · J. A. — Diciembre 12th 2023 at 17:17
Introduction

Brief interventions that reduce suicide risk following youth’s experience with acute care due to suicidality are needed.

Methods and analysis

The study will use a three-arm randomised controlled trial designed to test the effectiveness of the Safety Planning Intervention with structured follow-up (SPI+) and the Collaborative Assessment and Management of Suicidality (CAMS) compared with enhanced usual care. The primary outcomes measure will be suicidal events, defined as death by suicide, attempted suicide, preparatory acts toward imminent suicidal behaviour or suicidal ideation resulting in a change in emergency evaluation or inpatient admission. Secondary measures will be the number of suicide attempts and severity of suicidal ideation. The experimental interventions, SPI+ and CAMS, consist of up to eight sessions over approximately 8 weeks that are designed to manage (SPI+) or treat (CAMS) patient-identified ‘drivers’ of suicidal thoughts and behaviours. Mechanisms and moderators of change will be evaluated to understand treatment impacts.

Ethics and dissemination

This study has been approved by the Seattle Children’s Institutional Review Board and is monitored by external agencies including the University of Washington Institute for Translational Health Sciences, and a National Institute of Mental Health (NIMH)-appointed Data Safety and Monitoring Board. Trial results will help establish evidence towards safe and effective treatment strategies for youth transitioning from acute to outpatient care due to a suicidal crisis. The data will be shared with the NIMH Data Archives and disseminated through publications and conferences.

Trial registration number

NCT05078970.

☐ ☆ ✇ BMJ Open

How did New Zealands regional District Health Board groupings work to improve service integration and health outcomes: a realist evaluation

Por: Penno · E. · Atmore · C. · Maclennan · B. · Richard · L. · Wyeth · E. · Richards · R. · Doolan-Noble · F. · Gray · A. R. · Sullivan · T. · Gauld · R. · Stokes · T. — Diciembre 11th 2023 at 17:27
Objectives

In Aotearoa New Zealand (NZ), integration across the healthcare continuum has been a key approach to strengthening the health system and improving health outcomes. A key example has been four regional District Health Board (DHB) groupings, which, from 2011 to 2022, required the country’s 20 DHBs to work together regionally. This research explores how this initiative functioned, examining how, for whom and in what circumstances regional DHB groupings worked to deliver improvements in system integration and health outcomes and equity.

Design

We used a realist-informed evaluation study design. We used documentary analysis to develop programme logic models to describe the context, structure, capabilities, implementation activities and impact of each of the four regional groupings and then conducted interviews with stakeholders. We developed a generalised context-mechanisms-outcomes model, identifying key commonalities explaining how regional work ‘worked’ across NZ while noting important regional differences.

Setting

NZ’s four regional DHB groupings.

Participants

Forty-nine stakeholders from across the four regional groupings. These included regional DHB governance groups and coordinating regional agencies, DHB senior leadership, Māori and Pasifika leadership and lead clinicians for regional work streams.

Results

Regional DHB working was layered on top of an already complex DHB environment. Organisational heterogeneity and tensions between local and regional priorities were key contextual factors. In response, regional DHB groupings leveraged a combination of ‘hard’ policy and planning processes, as well as ‘soft’, relationship-based mechanisms, aiming to improve system integration, population health outcomes and health equity.

Conclusion

The complexity of DHB regional working meant that success hinged on building relationships, leadership and trust, alongside robust planning and process mechanisms. As NZ reorients its health system towards a more centralised model underpinned by collaborations between local providers, our findings point to a need to align policy expectations and foster environments that support connection and collegiality across the health system.

☐ ☆ ✇ BMJ Open

Impact of health system governance on healthcare quality in low-income and middle-income countries: a scoping review

Por: George · J. · Jack · S. · Gauld · R. · Colbourn · T. · Stokes · T. — Diciembre 11th 2023 at 17:27
Introduction

Improving healthcare quality in low-/middle-income countries (LMICs) is a critical step in the pathway to Universal Health Coverage and health-related sustainable development goals. This study aimed to map the available evidence on the impacts of health system governance interventions on the quality of healthcare services in LMICs.

Methods

We conducted a scoping review of the literature. The search strategy used a combination of keywords and phrases relevant to health system governance, quality of healthcare and LMICs. Studies published in English until August 2023, with no start date limitation, were searched on PubMed, Cochrane Library, CINAHL, Web of Science, Scopus, Google Scholar and ProQuest. Additional publications were identified by snowballing. The effects reported by the studies on processes of care and quality impacts were reviewed.

Results

The findings from 201 primary studies were grouped under (1) leadership, (2) system design, (3) accountability and transparency, (4) financing, (5) private sector partnerships, (6) information and monitoring; (7) participation and engagement and (8) regulation.

Conclusions

We identified a stronger evidence base linking improved quality of care with health financing, private sector partnerships and community participation and engagement strategies. The evidence related to leadership, system design, information and monitoring, and accountability and transparency is limited.

☐ ☆ ✇ BMJ Open

Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B Trial): protocol for a multicentre phase 3 pragmatic clinical and cost-effectiveness randomised trial in the UK

Por: Walsh · T. S. · Aitken · L. M. · McKenzie · C. A. · Boyd · J. · Macdonald · A. · Giddings · A. · Hope · D. · Norrie · J. · Weir · C. · Parker · R. A. · Lone · N. I. · Emerson · L. · Kydonaki · K. · Creagh-Brown · B. · Morris · S. · McAuley · D. F. · Dark · P. · Wise · M. P. · Gordon · A. C. — Diciembre 10th 2023 at 15:59
Introduction

Almost all patients receiving mechanical ventilation (MV) in intensive care units (ICUs) require analgesia and sedation. The most widely used sedative drug is propofol, but there is uncertainty whether alpha2-agonists are superior. The alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B) trial aims to determine whether clonidine or dexmedetomidine (or both) are clinically and cost-effective in MV ICU patients compared with usual care.

Methods and analysis

Adult ICU patients within 48 hours of starting MV, expected to require at least 24 hours further MV, are randomised in an open-label three arm trial to receive propofol (usual care) or clonidine or dexmedetomidine as primary sedative, plus analgesia according to local practice. Exclusions include patients with primary brain injury; postcardiac arrest; other neurological conditions; or bradycardia. Unless clinically contraindicated, sedation is titrated using weight-based dosing guidance to achieve a Richmond-Agitation-Sedation score of –2 or greater as early as considered safe by clinicians. The primary outcome is time to successful extubation. Secondary ICU outcomes include delirium and coma incidence/duration, sedation quality, predefined adverse events, mortality and ICU length of stay. Post-ICU outcomes include mortality, anxiety and depression, post-traumatic stress, cognitive function and health-related quality of life at 6-month follow-up. A process evaluation and health economic evaluation are embedded in the trial.

The analytic framework uses a hierarchical approach to maximise efficiency and control type I error. Stage 1 tests whether each alpha2-agonist is superior to propofol. If either/both interventions are superior, stages 2 and 3 testing explores which alpha2-agonist is more effective. To detect a mean difference of 2 days in MV duration, we aim to recruit 1437 patients (479 per group) in 40–50 UK ICUs.

Ethics and dissemination

The Scotland A REC approved the trial (18/SS/0085). We use a surrogate decision-maker or deferred consent model consistent with UK law. Dissemination will be via publications, presentations and updated guidelines.

Trial registration number

ClinicalTrials.gov NCT03653832.

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