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☐ ☆ ✇ BMJ Open

Predictive machine learning models for ascending aortic dilatation in patients with bicuspid and tricuspid aortic valves undergoing cardiothoracic surgery: a prospective, single-centre and observational study

Por: Gaye · B. · Vignac · M. · Gadin · J. R. · Ladouceur · M. · Caidahl · K. · Olsson · C. · Franco-Cereceda · A. · Eriksson · P. · Björck · H. M. — Marzo 20th 2024 at 16:56
Objectives

The objective of this study was to develop clinical classifiers aiming to identify prevalent ascending aortic dilatation in patients with bicuspid aortic valve (BAV) and tricuspid aortic valve (TAV).

Design and setting

A prospective, single-centre and observational cohort.

Participants

The study involved 543 BAV and 491 TAV patients with aortic valve disease and/or ascending aortic dilatation, excluding those with coronary artery disease, undergoing cardiothoracic surgery at the Karolinska University Hospital (Sweden).

Main outcome measures

Predictors of high risk of ascending aortic dilatation (defined as ascending aorta with a diameter above 40 mm) were identified through the application of machine learning algorithms and classic logistic regression models.

Exposures

Comprehensive multidimensional data, including valve morphology, clinical information, family history of cardiovascular diseases, prevalent diseases, demographic details, lifestyle factors, and medication.

Results

BAV patients, with an average age of 60.4±12.4 years, showed a higher frequency of aortic dilatation (45.3%) compared with TAV patients, who had an average age of 70.4±9.1 years (28.9% dilatation, p

Conclusion and recommendation

Cardiovascular risk profiles appear to be more predictive of aortopathy in TAV patients than in patients with BAV. This adds evidence to the fact that BAV-associated and TAV-associated aortopathy involves different pathways to aneurysm formation and highlights the need for specific aneurysm preventions in these patients. Further, our results highlight that machine learning approaches do not outperform classical prediction methods in addressing complex interactions and non-linear relations between variables.

☐ ☆ ✇ BMJ Open

Exploring the pharmacists role in optimising antithrombotic therapy in primary care: a qualitative study

Por: van Paassen · J. G. · Tan · J. P. · Deneer · V. H. M. · Bouvy · M. L. — Marzo 20th 2024 at 03:21
Objective

In antithrombotic therapy, the balance between efficacy and safety is delicate, which makes it challenging for healthcare professionals, including pharmacists, to optimise therapy. Pharmacists may play an important role in optimising antithrombotic therapy, but especially in primary care, this role has not been elucidated. Here, we study how community pharmacists (pharmacists in primary care) perceive their current and future role in antithrombotic therapy.

Design

We conducted a qualitative study using semi-structured interviews. The interview protocol and subsequent analysis were based on the Theoretical Domains Framework, and the findings were interpreted with the Capability Opportunity Motivation – Behaviour System.

Setting and participants

The interview participants were community pharmacists, located across the Netherlands, from the Utrecht Pharmacy Practice network for Education and Research.

Results

We interviewed 16 community pharmacists between February and August 2021 and identified several major themes which were important for the pharmacist’s role in antithrombotic therapy. Pharmacists felt responsible for the outcome of antithrombotic treatment and intended to invest in their role in antithrombotic therapy. Pharmacists did, however, experience barriers to their role in antithrombotic therapy, like a lack of access to clinical information such as the indication of antithrombotic treatment and a lack of specific knowledge on this treatment.

Conclusion

Community pharmacists perceive a role for themselves in antithrombotic therapy. To fulfil this role, several preconditions must be met.

☐ ☆ ✇ BMJ Open

Landscape of Metis health and wellness: protocol for a scoping review

Por: Boutros · H. M. · Koprich · S. · Simms · A. J. · Tsui · N. · Boyle · R.-A. · Harrison · J. · Riddell · M. · Sanftenberg · S. · Cripps · S. · Edwards · S. A. · Metis Nation of Ontario (MNO) — Marzo 9th 2024 at 02:25
Introduction

In Canada, Métis people are one of three distinct Indigenous peoples whose rights are recognised and affirmed in Section 35 of the federal Constitution Act, 1982. In line with Métis people having a unique culture, history, language and way of life, a distinctions-based approach is critical to understand the current landscape of Métis-specific health. In this paper, we present a scoping review protocol to describe this research landscape in Canada led by the Métis Nation of Ontario (MNO).

Methods and analysis

This scoping review protocol is reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews reporting guidelines and follows Arksey and O’Malley’s scoping review methodology. We will search electronic databases (Scopus, MEDLINE, Embase, Web of Science, CINAHL, APA PsycINFO, Anthropology Plus, Bibliography of Indigenous Peoples of North America, Canadian Business and Current Affairs, Indigenous Studies Portal, Informit Indigenous Collection, Collaborative Indigenous Garden, PubMed, ProQuest), grey literature sources and reference lists from selected papers. Two reviewers (HMB and SK) will double-blind screen all titles/abstracts and full-text studies for inclusion. Any health-related study or health report that includes a Métis-specific health, well-being or Métis social determinant of health outcome will be included. Relevant variables will be extracted following an iterative process whereby the data charting will be reviewed and updated.

Ethics and dissemination

Findings from this scoping review will be shared back through the MNO’s existing community-based communication channels. Traditional academic dissemination will also be pursued. Research ethics board approval is not required, since data are from peer-reviewed publications or publicly shared health reports and knowledge translation products.

☐ ☆ ✇ BMJ Open

Randomised trials conducted using cohorts: a scoping review

Por: Nickolls · B. J. · Relton · C. · Hemkens · L. · Zwarenstein · M. · Eldridge · S. · McCall · S. J. · Griffin · X. L. · Sohanpal · R. · Verkooijen · H. M. · Maguire · J. L. · McCord · K. A. — Marzo 9th 2024 at 02:25
Introduction

Cohort studies generate and collect longitudinal data for a variety of research purposes. Randomised controlled trials (RCTs) increasingly use cohort studies as data infrastructures to help identify and recruit trial participants and assess outcomes.

Objective

To examine the extent, range and nature of research using cohorts for RCTs and describe the varied definitions and conceptual boundaries for RCTs using cohorts.

Design

Scoping review.

Data sources

Searches were undertaken in January 2021 in MEDLINE (Ovid) and EBM Reviews—Cochrane Methodology Registry (Final issue, third Quarter 2012).

Eligibility criteria

Reports published between January 2007 and December 2021 of (a) cohorts used or planned to be used, to conduct RCTs, or (b) RCTs which use cohorts to recruit participants and/or collect trial outcomes, or (c) methodological studies discussing the use of cohorts for RCTs.

Data extraction and synthesis

Data were extracted on the condition being studied, age group, setting, country/continent, intervention(s) and comparators planned or received, unit of randomisation, timing of randomisation, approach to informed consent, study design and terminology.

Results

A total of 175 full-text articles were assessed for eligibility. We identified 61 protocols, 9 descriptions of stand-alone cohorts intended to be used for future RCTs, 39 RCTs using cohorts and 34 methodological papers.

The use and scope of this approach is growing. The thematics of study are far-ranging, including population health, oncology, mental and behavioural disorders, and musculoskeletal conditions.

Authors reported that this approach can lead to more efficient recruitment, more representative samples, and lessen disappointment bias and crossovers.

Conclusion

This review outlines the development of cohorts to conduct RCTs including the range of use and innovative changes and adaptations. Inconsistencies in the use of terminology and concepts are highlighted. Guidance now needs to be developed to support the design and reporting of RCTs conducted using cohorts.

☐ ☆ ✇ BMJ Open

Prevalence and determinants of antibiotics self-medication among indigenous people of Bangladesh: a cross-sectional study

Por: Mannan · A. · Chakma · K. · Dewan · G. · Saha · A. · Chy · N. U. H. A. · Mehedi · H. M. H. · Hossain · A. · Wnaiza · J. · Ahsan · M. T. · Rana · M. M. · Alam · N. — Marzo 6th 2024 at 05:12
Objectives

Self-medication with antibiotics (SMA) contributes significantly to the emergence of antimicrobial resistance (AMR), especially in low-income countries including Bangladesh. This study aimed to generate evidence on the self-reported prevalence of antibiotic self-medication and its determinants among indigenous people residing in Bangladesh’s Chittagong Hill Tracts (CHT) districts.

Design

This study used a cross-sectional design with data collected through a survey using a semi-structured questionnaire.

Setting

This study was conducted from late January to early July 2021; among different indigenous group populations aged 18 years or more olders residing in the three districts of CHT.

Participants

A total of 1336 indigenous people residing in Bangladesh’s CHT districts were included.

Primary outcome and explanatory variables

The primary outcome measure was SMA while explanatory variables were socio-demographic characteristics, health status of participants, and knowledge of antibiotics usage and its side effects.

Results

Among the study participants, more males (60.54%) than females (51.57%) reported using antibiotics. The SMA rate was high among individuals with education levels below secondary (over 50%) and those in the low-income group (55.19%). The most common diseases reported were cough, cold and fever, with azithromycin being the most frequently used antibiotic. Levels of education, family income, having a chronic illness and place of residence were found to be the significant predictors of having good knowledge of antibiotic use as found in the ordered logit model. Findings from a logistic regression model revealed that men had 1.6 times higher odds (adjusted OR (AOR) 1.57; 95% CI 1.12 to 2.19) of SMA than women. Participants with ≥US$893 per month family income had lowest odds (AOR 0.14; 95% CI 0.03 to 0.64) of SMA than those who earned

Conclusion

Male gender, family income, place of residence and knowledge of antibiotics were the significant predictors of antibiotic self-medication. Hence, it is important to streamline awareness-raising campaigns at the community level to mitigate the practice of SMA in indigenous people and ultimately address the devastating effects of Antimicrobial resistance (AMR) in Bangladesh.

☐ ☆ ✇ BMJ Open

Efficacy and safety of deferoxamine, deferasirox and deferiprone triple iron chelator combination therapy for transfusion-dependent {beta}-thalassaemia with very high iron overload: a protocol for randomised controlled clinical trial

Por: Premawardhena · A. · Perera · C. · Wijethilaka · M. N. · Wanasinghe · S. K. · Rajakaruna · R. H. M. G. · Samarasinghe · R. A. N. K. K. · Williams · S. · Mettananda · S. — Febrero 9th 2024 at 02:19
Introduction

Despite the improvement in medical management, many patients with transfusion-dependent β-thalassaemia die prematurely due to transfusion-related iron overload. As per the current guidelines, the optimal chelation of iron cannot be achieved in many patients, even with two iron chelators at their maximum therapeutic doses. Here, we evaluate the efficacy and safety of triple combination treatment with deferoxamine, deferasirox and deferiprone over dual combination of deferoxamine and deferasirox on iron chelation in patients with transfusion-dependent β-thalassaemia with very high iron overload.

Methods and analysis

This is a single-centre, open-label, randomised, controlled clinical trial conducted at the Adult and Adolescent Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into intervention or control groups. The intervention arm will receive a combination of oral deferasirox, oral deferiprone and subcutaneous deferoxamine for 6 months. The control arm will receive the combination of oral deferasirox and subcutaneous deferoxamine for 6 months. Reduction in iron overload, as measured by a reduction in the serum ferritin after completion of the treatment, will be the primary outcome measure. Reduction in liver and cardiac iron content as measured by T2* MRI and the side effect profile of trial medications are the secondary outcome measures.

Ethics and dissemination

Ethical approval for the study has been obtained from the Ethics Committee of the Faculty of Medicine, University of Kelaniya (Ref. P/06/02/2023). The trial results will be disseminated in scientific publications in reputed journals.

Trial registration number

The trial is registered in the Sri Lanka Clinical Trials Registry (Ref: SLCTR/2023/010).

☐ ☆ ✇ BMJ Open

IMPAACT: IMproving the PArticipAtion of older people in policy decision-making on common health CondiTions - a study protocol

Por: Ambagtsheer · R. C. · Hurley · C. J. · Lawless · M. · Braunack-Mayer · A. · Visvanathan · R. · Beilby · J. · Stewart · S. · Cornell · V. · Leach · M. J. · Taylor · D. · Thompson · M. · Dent · E. · Whiteway · L. · Archibald · M. · O'Rourke · H. M. · Williams · K. · Chudecka · A. — Enero 12th 2024 at 16:58
Introduction

Rapid population ageing is a demographic trend being experienced and documented worldwide. While increased health screening and assessment may help mitigate the burden of illness in older people, issues such as misdiagnosis may affect access to interventions. This study aims to elicit the values and preferences of evidence-informed older people living in the community on early screening for common health conditions (cardiovascular disease, diabetes, dementia and frailty). The study will proceed in three Phases: (1) generating recommendations of older people through a series of Citizens’ Juries; (2) obtaining feedback from a diverse range of stakeholder groups on the jury findings; and (3) co-designing a set of Knowledge Translation resources to facilitate implementation into research, policy and practice. Conditions were chosen to reflect common health conditions characterised by increasing prevalence with age, but which have been underexamined through a Citizens’ Jury methodology.

Methods and analysis

This study will be conducted in three Phases—(1) Citizens’ Juries, (2) Policy Roundtables and (3) Production of Knowledge Translation resources. First, older people aged 50+ (n=80), including those from traditionally hard-to-reach and diverse groups, will be purposively recruited to four Citizen Juries. Second, representatives from a range of key stakeholder groups, including consumers and carers, health and aged care policymakers, general practitioners, practice nurses, geriatricians, allied health practitioners, pharmaceutical companies, private health insurers and community and aged care providers (n=40) will be purposively recruited for two Policy Roundtables. Finally, two researchers and six purposively recruited consumers will co-design Knowledge Translation resources. Thematic analysis will be performed on documentation and transcripts.

Ethics and dissemination

Ethical approval has been obtained through the Torrens University Human Research Ethics Committee. Participants will give written informed consent. Findings will be disseminated through development of a policy brief and lay summary, peer-reviewed publications, conference presentations and seminars.

☐ ☆ ✇ BMJ Open

Cannabis for medical use versus opioids for chronic non-cancer pain: a systematic review and network meta-analysis of randomised clinical trials

Por: Jeddi · H. M. · Busse · J. W. · Sadeghirad · B. · Levine · M. · Zoratti · M. J. · Wang · L. · Noori · A. · Couban · R. J. · Tarride · J.-E. — Enero 3rd 2024 at 17:10
Objective

The objective of this study is to evaluate the comparative benefits and harms of opioids and cannabis for medical use for chronic non-cancer pain.

Design

Systematic review and network meta-analysis.

Data sources

EMBASE, MEDLINE, CINAHL, AMED, PsycINFO, PubMed, Web of Science, Cannabis-Med, Epistemonikos and the Cochrane Library (CENTRAL) from inception to March 2021.

Study selection

Randomised trials comparing any type of cannabis for medical use or opioids, against each other or placebo, with patient follow-up ≥4 weeks.

Data extraction and synthesis

Paired reviewers independently extracted data. We used Bayesian random-effects network meta-analyses to summarise the evidence and the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach to evaluate the certainty of evidence and communicate our findings.

Results

Ninety trials involving 22 028 patients were eligible for review, among which the length of follow-up ranged from 28 to 180 days. Moderate certainty evidence showed that opioids provide small improvements in pain, physical functioning and sleep quality versus placebo; low to moderate certainty evidence supported similar effects for cannabis versus placebo. Neither was more effective than placebo for role, social or emotional functioning (all high to moderate certainty evidence). Moderate certainty evidence showed there is probably little to no difference between cannabis for medical use and opioids for physical functioning (weighted mean difference (WMD) 0.47 on the 100-point 36-item Short Form Survey physical component summary score, 95% credible interval (CrI) –1.97 to 2.99), and cannabis resulted in fewer discontinuations due to adverse events versus opioids (OR 0.55, 95% CrI 0.36 to 0.83). Low certainty evidence suggested little to no difference between cannabis and opioids for pain relief (WMD 0.23 cm on a 10 cm Visual Analogue Scale (VAS), 95% CrI –0.06 to 0.53) or sleep quality (WMD 0.49 mm on a 100 mm VAS, 95% CrI –4.72 to 5.59).

Conclusions

Cannabis for medical use may be similarly effective and result in fewer discontinuations than opioids for chronic non-cancer pain.

PROSPERO registration number

CRD42020185184.

☐ ☆ ✇ BMJ Open

THromboprophylaxis In Sickle Cell Disease with central venous catheters (THIS): an internal pilot randomised controlled trial protocol

Por: Abdulrehman · J. · Forte · S. · Tomlinson · G. · Solh · Z. · Bolster · L. · Sun · H. · Bartolucci · P. · Kuo · K. H. M. — Enero 3rd 2024 at 17:10
Introduction

Individuals with sickle cell disease (SCD) and central venous catheters (CVC) are at high risk for venous thromboembolism (VTE). Minimal data exist regarding the use of anticoagulation as thromboprophylaxis of VTE in this demographic, and as a result, clinical equipoise exists. Prophylactic dose rivaroxaban, a direct oral anticoagulant, is efficacious and safe as thromboprophylaxis in other demographics, and may be an optimal agent in SCD with CVC. Prior to conducting a full clinical trial to assess rivaroxaban as thromboprophylaxis in SCD with CVC, a pilot study is needed to gauge its feasibility.

Methods and analysis

THromboprophylaxis In Sickle Cell Disease pilot trial is an investigator-initiated, multicentre, double-blinded, randomised controlled trial (RCT) assessing if it is feasible and safe to conduct an adequately powered RCT comparing rivaroxaban to matching placebo as thromboprophylaxis in those with SCD and CVC. Fifty adult patients with SCD and CVC will be randomised to receive either rivaroxaban 10 mg daily or matching placebo for the duration of the CVC in situ for up to 1 year. After randomisation, follow-up visits will occur every 3 months. The primary outcomes pertain to the feasibility of a full trial and include numbers of eligible and recruited participants. Exploratory outcomes include overall incidence of VTE and bleeding complications, as well as quality of life. If the full trial is feasible, blinding will be maintained and patients in the pilot study will be included in the full trial.

Ethics and dissemination

The trial was initially approved by the University Health Network Research Ethics Board (REB) in Toronto, Canada. All sites will obtain approval from their respective REB prior to commencement of study activities. Study results will be disseminated through presentations at medical conferences and peer-reviewed publications.

Trial registration number

NCT05033314.

☐ ☆ ✇ BMJ Open

Characterisation of internal tremors and vibration symptoms

Por: Massey · D. · Sawano · M. · Baker · A. D. · Güthe · D. B. · Güthe · N. · Shidlovsky · S. P. · Fisher · L. · Grady · C. B. · Caraballo · C. · Zhou · T. · Sharma · R. · Krumholz · H. M. — Diciembre 28th 2023 at 16:47
Objectives

To describe the experiences of patients who have postacute sequelae SARS-CoV-2 infection with internal vibrations and tremors as a prominent component, we leveraged the efforts by Survivor Corps, a grassroots COVID-19 patient advocacy group, to gather information from individuals belonging to its Facebook group with a history of COVID-19 suffering from vibrations and tremors.

Setting and design

A narrative analysis was performed on 140 emails and 450 social media comments from 140 individuals collected as a response to a call to >180 000 individuals participating in Survivor Corps between 15 July and 27 July 2021. We used common coding techniques and the constant comparative method for qualitative data synthesis and categorising emails. Coded data were entered into NVivo V.12 to identify recurrent themes, theme connections and supporting quotations. Comments were analysed using Word Clouds, generated with R V.4.0.3 using quanteda, wordcloud and tm packages.

Main outcome measures

Patient-reported long COVID symptom themes and domains related to internal tremors and vibration.

Results

The respondents’ emails represented 22 themes and 7 domains pertaining to their experience with internal tremor and vibrations. These domains were as follows: (1) symptom experience, description and anatomic location; (2) initial symptom onset; (3) symptom timing; (4) symptom triggers or alleviators; (5) change from baseline health status; (6) experience with medical establishment and (7) impact on individuals’ lives and livelihood. There were 22 themes in total, each corresponding to one of the broader domains. Among the responses, many described symptoms that varied in location, timing and triggers, occurred soon after their COVID-19 infection, and were markedly debilitating. There were often frustrating experiences with the healthcare system.

Conclusions

This study describes key themes and experiences among a group of people reporting long COVID and having a prolonged and debilitating symptom complex that prominently features internal tremors and vibrations.

☐ ☆ ✇ BMJ Open

Genital tract infections, the vaginal microbiome and gestational age at birth among pregnant women in South Africa: a cohort study protocol

Por: Gigi · R. M. S. · Mdingi · M. M. · Jung · H. · Claassen-Weitz · S. · Bütikofer · L. · Klausner · J. D. · Muzny · C. A. · Taylor · C. M. · van de Wijgert · J. H. H. M. · Peters · R. P. H. · Low · N. — Diciembre 28th 2023 at 16:47
Introduction

Preterm birth complications are the most common cause of death in children under 5 years. The presence of multiple microorganisms and genital tract inflammation could be the common mechanism driving early onset of labour. South Africa has high levels of preterm birth, genital tract infections and HIV infection among pregnant women. We plan to investigate associations between the presence of multiple lower genital tract microorganisms in pregnancy and gestational age at birth.

Methods and analysis

This cohort study enrols around 600 pregnant women at one public healthcare facility in East London, South Africa. Eligible women are ≥18 years and at Chlamydia trachomatis and Neisseria gonorrhoeae, with treatment if test results are positive. At these visits, additional vaginal specimens are taken for: PCR detection and quantification of Trichomonas vaginalis, Candida spp., Mycoplasma genitalium, M. hominis, Ureaplasma urealyticum and U. parvum; microscopy and Nugent scoring; and for 16S ribosomal RNA gene sequencing and quantification. Pregnancy outcomes are collected from a postnatal visit and birth registers. The primary outcome is gestational age at birth. Statistical analyses will explore associations between specific microorganisms and gestational age at birth. To explore the association with the quantity of microorganisms, we will construct an index of microorganism load and use mixed-effects regression models and classification and regression tree analysis to examine which combinations of microorganisms contribute to earlier gestational age at birth.

Ethics and dissemination

This protocol has approvals from the University of Cape Town Research Ethics Committee and the Canton of Bern Ethics Committee. Results from this study will be uploaded to preprint servers, submitted to open access peer-reviewed journals and presented at regional and international conferences.

Trial registration number

NCT06131749; Pre-results.

☐ ☆ ✇ BMJ Open

Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol

Por: Hanssen · H. M. · Fjellstad · M. S. · Skjevling · L. · Johnsen · P. H. · Kulseng · B. · Goll · R. · Alma · K. H. · Valle · P.-C. — Diciembre 27th 2023 at 10:54
Introduction

Obesity is one of the main threats to public health in western countries and increases the risk of several diseases, overall morbidity and mortality. Sustained weight loss will reduce risk factors and improve several obesity comorbidities. Options are conservative treatment such as lifestyle changes, bariatric surgery or medications. Conservative treatment has a low success rate, and bariatric surgery is typically not reversible, with the risk of complications and recurrences. Treatment of obesity with medications has in recent years shown great promise, but the side effects are many, and the long-term effect is unknown. There is also a need for an option for patients where surgery has contraindications and conservative follow-up does not succeed.

The research on obesity and gut microbiota has yielded promising results regarding weight reduction and metabolic health, but more research is needed to better understand the relationship between gut microbiota and severe obesity. This study could show proof of concept that gut microbiota from a lean donor could, in addition to lifestyle intervention, contribute to weight reduction in people suffering from severe obesity.

Method and analysis

This study aims to investigate if a fecal microbiota transplantation (FMT) from a lean donor leads to weight reduction in participants suffering from severe obesity. The study is a single-centre, double-blinded, placebo-controlled, parallel-group study with 60 participants. Participants will be randomised 1:1 for FMT from a lean donor or placebo. FMT or placebo will be delivered once by enema.

We will include participants from the outpatient clinic for severe obesity, at the Medical Department, University Hospital of North Norway, Harstad, by invitation only. The study has a follow-up period of 12 months, with study visits of 3, 6 and 12 months post FMT. The primary endpoint is a weight reduction of ≥10%, 12 months after intervention.

The results of the study will be published in open access journals. At the end of the study, the participants will receive information on which treatment group they belong to.

Ethics and dissemination

The Regional Ethical Committee in North Norway (REK) approved the study protocol (2017/1655/REK Nord). We plan to present the results from the study at (inter)national conferences and publish in open-access general peer-reviewed journals. The enema method for FMT administration used in this study was developed by our study team.

Trial registration number

NCT03273855.

☐ ☆ ✇ BMJ Open

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. — Diciembre 10th 2023 at 15:59
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/

☐ ☆ ✇ BMJ Open

Assessing the risk of COVID-19 reinfection and severe outcomes among individuals with substance use disorders: a retrospective study using real-world electronic health records

Por: Tuan · W.-J. · Kindt · H. M. · Lennon · R. P. — Diciembre 10th 2023 at 15:59
Objective

Despite advancement in vaccines and treatments for COVID-19 over the past 2 years, many concerns remain about reinfection and waning immunity against COVID-19 and its variants, especially among people with substance use disorder (SUD). The study assessed the risk of COVID-19 reinfection and severe illness among adults with SUD and their vaccination status to inform management in this vulnerable population as the pandemic continues.

Design

Retrospective cohort study.

Setting

Nationwide electronic health records (TriNetX database) in the USA among adults with COVID-19 infection from January 2020 to June 2022.

Participants

Adults (age ≥18 years) who were infected by COVID-19, excluding those who had cancer or lived in nursing homes or palliative care facilities.

Outcome measures

COVID-19 reinfection was defined as a new diagnosis after 45 days of the initial infection. Logistic regression was applied to assess the OR of COVID-19 reinfection and severe outcomes within 30 day of reinfection for adults with alcohol (AUD), opioid (OUD), cocaine (CUD), stimulant (STUD), cannabis (CAUD) and other use disorders, controlled for demographic and comorbid conditions.

Results

The SUD cohort was 13%–29% more likely to be reinfected by COVID-19 and had significantly higher 30-day mortality. Adults with AUD, STUD and OUD were at greater risks (adjusted ORs, AORs=1.69–1.86) of emergency department, hospital and intensive care admissions after 30 days of reinfection. Individuals with SUD and multiple vaccines doses were associated with decreased risks of worse COVID-19 outcomes. Lower COVID-19 reinfection rates (AORs=0.67–0.84) were only found among individuals with AUD, CUD or CAUD who had COVID-19 vaccination.

Conclusions

Individuals with SUD had greater risks of COVID-19 reinfection and poor outcomes, especially those with OUD, STUD and AUD. Multiple vaccinations are recommended to reduce severe illness after COVID-19 reinfection in the SUD population.

☐ ☆ ✇ BMJ Open

Eliciting preferences of persons with dementia and informal caregivers to support ageing in place in the Netherlands: a protocol for a discrete choice experiment

Por: Vullings · I. · Wammes · J. · Uysal-Bozkir · O. · Smits · C. · Labrie · N. H. M. · Swait · J. D. · de Bekker-Grob · E. · Macneil-Vroomen · J. L. — Diciembre 10th 2023 at 15:59
Introduction

Ageing in place (AIP) for persons with dementia is encouraged by European governments and societies. Healthcare packages may need reassessment to account for the preferences of care funders, patients and informal caregivers. By providing insight into people’s preferences, discrete choice experiments (DCEs) can help develop consensus between stakeholders. This protocol paper outlines the development of a Dutch national study to cocreate a healthcare package design methodology built on DCEs that is person-centred and helps support informal caregivers and persons with dementia to AIP. A subpopulation analysis of persons with dementia with a migration background is planned due to their high risk for dementia and under-representation in research and care.

Methods and analysis

The DCE is designed to understand how persons with dementia and informal caregivers choose between different healthcare packages. Qualitative methods are used to identify and prioritise important care components for persons with dementia to AIP. This will provide a list of care components that will be included in the DCE, to quantify the care needs and preferences of persons with dementia and informal caregivers. The DCE will identify individual and joint preferences to AIP. The relative importance of each attribute will be calculated. The DCE data will be analysed with the use of a random parameters logit model.

Ethics and dissemination

Ethics approval was waived by the Amsterdam University Medical Center (W23_112 #23.137). A study summary will be available on the websites of Alzheimer Nederland, Pharos and Amsterdam Public Health institute. Results are expected to be presented at (inter)national conferences, peer-reviewed papers will be submitted, and a dissemination meeting will be held to bring stakeholders together. The study results will help improve healthcare package design for all stakeholders.

☐ ☆ ✇ BMJ Open

Designing intervention prototypes to improve infant and young child nutrition in Peru: a participatory design study protocol

Por: Rousham · E. · Pareja · R. G. · Creed-Kanashiro · H. M. · Bartolini · R. · Pradeilles · R. · Ortega-Roman · D. · Holdsworth · M. · Griffiths · P. · Verdezoto · N. — Diciembre 9th 2023 at 17:51
Introduction

Nutrition during the complementary feeding period (6–23 months) is critical to ensure optimal growth and reduce the risk of diet-related disease across the life course. Strategies to reduce multiple forms of malnutrition (stunting, overweight/obesity and anaemia) in infants and young children (IYC) are a key priority in low-income and middle-income countries, including Peru. This study aims to co-design and develop prototypes for interventions to address the multiple forms of malnutrition in IYC in urban Peru, using a participatory design approach.

Methods and analysis

The study will be based within peri-urban communities in two areas of Peru (Lima and Huánuco city). Following the identification of key nutritional challenges for IYC aged 6–23 months through formative research (phase I), we will conduct a series of workshops bringing together healthcare professionals from government health centres and caregivers of IYC aged 6–23 months. Workshops (on idea generation; creating future scenarios; storyboarding and early implementation and feedback) will take place in parallel in the two study areas. Through these workshops, we will engage with community participants to explore, experiment, co-design and iteratively validate new design ideas to address the challenges around IYC complementary feeding from phase I. Workshop outputs and transcripts will be analysed qualitatively using affinity diagramming and thematic analyses. The intervention prototypes will be evaluated qualitatively and piloted with the participating communities.

Ethics and dissemination

Ethical approval for this study was obtained from the Ethical Review Committee of the Instituto de Investigación Nutricional (IIN) Peru (388-2019/CIEI-IIN), Loughborough University (C19-87) and confirmed by Cardiff University. Findings of the participatory design process will be disseminated through a deliberative workshop in Lima, Peru with national and regional government stakeholders, as well as participants and researchers involved in the design process. Further dissemination will take place through policy briefs, conferences and academic publications.

☐ ☆ ✇ BMJ Open

Sustainable development goals and multisectoral collaborations for child health in Cambodia: a qualitative interview study with key child health stakeholders

Por: Hellden · D. · Sok · S. · Chea · T. · Nordenstedt · H. · Kuruvilla · S. · Alvesson · H. M. · Alfven · T. — Noviembre 21st 2023 at 17:16
Objectives

Multisectoral collaboration highlighted as key in delivering on the Sustainable Development Goals (SDGs), but still little is known on how to move from rhetoric to action. Cambodia has made remarkable progress on child health over the last decades with multisectoral collaborations being a key success factor. However, it is not known how country stakeholders perceive child health in the context of the SDGs or multisectoral collaborations for child health in Cambodia.

Design, settings and participants

Through purposive sampling, we conducted semistructured interviews with 29 key child health stakeholders from a range of government and non-governmental organisations in Cambodia. Guided by framework analysis, themes, subthemes and categories were derived.

Results

We found that the adoption of the SDGs led to increased possibility for action and higher ambitions for child health in Cambodia, while simultaneously establishing child health as a multisectoral issue among key child stakeholders. There seems to be a discrepancy between the desired step-by-step theory of conducting multisectoral collaboration and the real-world complexities including funding and power dynamics that heavily influence the process of collaboration. Identified success factors for multisectoral collaborations included having clear responsibilities, leadership from all and trust among stakeholders while the major obstacle found was lack of sustainable funding.

Conclusion

The findings from this in-depth multistakeholder study can inform policy-makers and practitioners in other countries on the theoretical and practical process as well as influencing aspects that shape multisectoral collaborations in general and for child health specifically. This is vital if multisectoral collaborations are to be successfully leveraged to accelerate the work towards achieving better child health in the era of the SDGs.

☐ ☆ ✇ BMJ Open

Effects of Eurycoma longifolia Jack standardised water extract (Physta) on well-being of perimenopausal and postmenopausal women: protocol for a randomised, double-blinded, placebo-controlled, parallel group study

Por: Muniandy · S. · Yahya · H. M. · Shahar · S. · Kamisan Atan · I. · Mahdy · Z. A. · Rajab · N. F. · George · A. · Chinnappan · S. M. — Noviembre 1st 2023 at 16:42
Introduction

Eurycoma longifolia Jack (EL), profoundly recognised as ‘Tongkat Ali’, is a medicinal herb originating from Southeast Asia. It is commonly used in traditional ‘antiageing’ treatments to address decreased energy, mood, libido and hormonal imbalances. While the benefits of EL have been extensively studied among the male population, less attention has been given to its effects on women. Menopause can impact the overall well-being of middle-aged women and incorporation of herbal supplements can aid them in managing the menopausal symptoms.

Methods and analysis

This 12-week randomised double-blind, placebo-controlled, parallel-group study aims to evaluate the efficacy of the standardised water extract of EL known as Physta in increasing the quality of life of perimenopausal and postmenopausal women. The study involves 150 women aged 40–55 years who score more than 61 on the Menopause-Specific Quality of Life (MENQOL) assessment. These participants will be randomised into three groups, receiving Physta at either 50 mg or 100 mg or a placebo. The outcomes measures include mood state, quality of life, fatigue, sleep quality, sexual function and pain score assessed using Profile of Mood State, MENQOL, Chalder Fatigue Scale, Pittsburgh Sleep Quality Index, Female Sexual Function Index and the Brief Pain Inventory questionnaires, respectively. The secondary outcome of the study includes full blood analysis, urine analysis, female reproductive hormone profiling, inflammatory and oxidative stress biomarkers analysis.

Ethics and dissemination

The research protocol of the study was reviewed and approved by the Research Ethics Committee of Universiti Kebangsaan Malaysia (UKM/PPI/111/8/JEP-2021-898). The findings will be disseminated to participants, healthcare professionals and researchers via conference presentations and peer-reviewed publications.

Trial registration number

ACTRN12622001341718.

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