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Non-pharmacological interventions to support coronary artery bypass graft (CABG) patient recovery following discharge: protocol for a scoping review

Por: Billard · J. N. · Wells · R. · Farrell · A. · Curran · J. A. · Sheppard · G.
Background

In Canada, approximately 15 000 people undergo coronary artery bypass grafting (CABG) each year. However, 9.5% of these patients are urgently readmitted to hospital within 30 days of surgery. Postoperative interventions following discharge play an important role in reducing readmissions and improving CABG patient outcomes. Therefore, it is important to determine effective interventions available to enhance CABG patient recovery following postoperative discharge.

Objectives

Our scoping review aims to identify non-pharmacological interventions available to support recovery of patients who are discharged after CABG in the community setting.

Methods

The methodological framework described by Arksey and O’Malley will be applied to this review. Our search strategy will include electronic databases (Medline, Embase, Cochrane Library and CINAHL), and studies will be screened and reviewed by two independent reviewers. Studies looking at non-pharmacological interventions targeting patients who are discharged after CABG will be included. Preliminary searches were conducted March 2022 and following abstract screening, full-text screening was completed May 2023. Data extraction is planned to begin September 2023 with an expected finish date of October 2023. The study is expected to be completed by January 2024.

Ethics and dissemination

This scoping review will retrieve and analyse previously published studies in which informed consent was obtained by primary investigators. Therefore, no ethical review or approval will be required. This scoping review aims to enumerate available non-pharmacological interventions to support recovery of patients who are discharged after CABG and identify gaps in postoperative recovery after discharge to support the development of innovative and targeted interventions. On completion of this review, we will ensure broad dissemination of our findings through peer-reviewed, open-access journals, conference presentations and hold meetings to engage stakeholders, including clinicians, policy makers and others.

Feasibility and acceptability of offering breast cancer risk assessment to general population women aged 30-39 years: a mixed-methods study protocol

Por: Hindmarch · S. · Howell · S. J. · Usher-Smith · J. A. · Gorman · L. · Evans · D. G. · French · D. P.
Introduction

Breast cancer incidence starts to increase exponentially when women reach 30–39 years, hence before they are eligible for breast cancer screening. The introduction of breast cancer risk assessment for this age group could lead to those at higher risk receiving benefits of earlier screening and preventive strategies. Currently, risk assessment is limited to women with a family history of breast cancer only. The Breast CANcer Risk Assessment in Younger women (BCAN-RAY) study is evaluating a comprehensive breast cancer risk assessment strategy for women aged 30–39 years incorporating a questionnaire of breast cancer risk factors, low-dose mammography to assess breast density and polygenic risk. This study will assess the feasibility and acceptability of the BCAN-RAY risk assessment strategy.

Methods and analysis

This study involves women undergoing risk assessment as part of the BCAN-RAY case-control study (n=750). They will be aged 30–39 years without a strong family history of breast cancer and invited to participate via general practice. A comparison of uptake rates by socioeconomic status and ethnicity between women who participated in the BCAN-RAY study and women who declined participation will be conducted. All participants will be asked to complete self-report questionnaires to assess key potential harms including increased state anxiety (State Trait Anxiety Inventory), cancer worry (Lerman Cancer Worry Scale) and satisfaction with the decision to participate (Decision Regret Scale), alongside potential benefits such as feeling more informed about breast cancer risk. A subsample of approximately 24 women (12 at average risk and 12 at increased risk) will additionally participate in semistructured interviews to understand the acceptability of the risk assessment strategy and identify any changes needed to it to increase uptake.

Ethics and dissemination

Ethical approval was granted by North West—Greater Manchester West Research Ethics Committee (reference: 22/NW/0268). Study results will be disseminated through peer-reviewed journals, conference presentations and charitable organisations.

Trial registration number

NCT05305963.

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

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

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

Design

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

Setting

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

Participants

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

Interventions

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

Primary and secondary outcome measures

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

Results

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

Conclusions

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

Trial registration number

NCT03096509.

Clinical profile and outcomes of paediatric patients with acute seizures: a prospective cohort study at an urban emergency department of a tertiary hospital in Tanzania

Por: Shayo · F. · Sawe · H. R. · Hyuha · G. M. · Moshi · B. · Gulamhussein · M. A. · Mussa · R. · Mdundo · W. · Rwegoshora · S. · Mfinanga · J. A. · Kilindimo · S. · Weber · E. J.
Objective

Children with seizures require immediate and appropriate intervention in the emergency department (ED). This study describes the clinical profile and outcome of paediatric patients with seizures at the ED in a country with limited resources.

Design

A prospective, observational cohort study of paediatric patients with seizure presenting to an ED conducted over a six-month period from 1 August 2019 to 31 January2020.

Setting

The study was conducted at the ED of Muhimbili National Hospital, a level 1 trauma centre located in Dar es Salaam, Tanzania.

Participants

Paediatric patients aged 1 month to 14 years presenting at the ED with acute seizure, defined as any seizure occurring from 24 hours to 7 days prior to the visit, were included in this study. Patients were consecutively enrolled during times a research assistant was present in the department. Newborns, children with repeat visits or no signs of life on arrival were excluded.

Outcome

The primary outcome was the proportion of paediatric patients presenting with seizures and their mortality rate; secondary outcome was risk factors for mortality.

Result

During the study period, 1011 children were seen in the department, of whom 114 (11.3%) (95% CI 9.3% to 13.3%) presented with seizures. Median age was 24 months (IQR 9–60), 78.1% were under 5 years and 55.3% were males. The majority 76 (66.7%) of the patients presented with generalised seizures. Half 58 (50.9%) of patients presented with fever. Meningitis was the most common aetiology, diagnosed in 30 (26.3%). Overall mortality was 16.7% (95% CI 10.3% to 24.8%). Using negative log binominal analysis, fever (relative risk, RR 2.7), altered mental status (RR 21.1), hypoxia (RR 3.3), abnormal potassium (RR 2.4) and clinical diagnosis of meningitis (RR 3.4) were statistically significantly associated with mortality.

Conclusions

Findings from this study revealed higher incidence of paediatric patients with seizures than that reported in high-income countries and other low-income and middle-income countries. The acuity of illness was high, with 16.7% mortality rate. The presence of fever, altered mental status, hypoxia, abnormal potassium levels and meningitis diagnosis were associated with higher risk of mortality. Further research is needed to develop interventions to improve outcomes in paediatric patients with seizures in our setting.

Amantadine and/or transcranial magnetic stimulation for fatigue associated with multiple sclerosis (FETEM): study protocol for a phase 3 randomised, double-blind, cross-over, controlled clinical trial

Por: Matias-Guiu · J. A. · Gonzalez-Rosa · J. · Hernandez · M. A. · Martinez-Gines · M. L. · Portoles · A. · Perez-Macias · N. · Benito-Leon · J. · Padron · I. · Prieto · J. · Matias-Guiu · J.
Introduction

Fatigue is one of the most disabling symptoms of multiple sclerosis (MS), and effective treatments are lacking. Amantadine is one of the most used treatments, although its efficacy is under debate. Transcranial magnetic stimulation (TMS) is a promising intervention that has shown positive effects in some preliminary investigations. We aim to investigate the effect of 6 weeks of amantadine and/or TMS in fatigue due to MS.

Methods and analysis

The study is a national, multicentre, phase 3, randomised, double-blind, cross-over, placebo-controlled and sham-controlled clinical trial. Adult patients with relapsing-remitting MS, Expanded Disability Status Scale score of 1.5–4.5 and Fatigue Severity Score>4 are eligible for the trial. Participants will be randomised to one of the sequences of the study. Each sequence consists of four periods of 6 weeks of treatment and three washout periods of 12–18 weeks. All patients will receive all the combinations of therapies. The primary outcome is the Modified Fatigue Impact Scale. The secondary outcomes are the Symbol Digit Modalities Test (cognition), Beck Depression Inventory-II (depressive symptoms) and Short-Survey 12 (quality of life). Safety and cost-effectiveness will also be evaluated. An exploratory substudy including MRI and blood biomarkers will be conducted.

Ethics and dissemination

The study is approved by the Ethics Committee of the Hospital Clinico San Carlos and the Spanish Agency of Medications and Medical Devices. All study findings will be published in scientific peer-reviewed journals and presented at relevant scientific conferences.

Trial registration number

EudraCT 2021-004868-95; NCT05809414.

Perceptions of academic staff and students of senior high school in implementing game-based exercises in physical education classes--a research protocol for a qualitative descriptive study

Por: Manlapaz · D. · Vergara · J. A. · Alpuerto · K. M. B. · De Los Santos · I. K. S. · Enriquez · M. U. · Manicio · Z. Z. · Mendres · J. E. F. · Tolosa · C. G. S. · Vilela · Z. G. D. · Zabat · Z. E. G. A.
Background

The COVID-19 pandemic has taken a toll on both physical activity and fitness as several pursuits and activities have been restricted. Coupled with this, increased food intake and sedentary lifestyles have produced poor physical health outcomes. Online physical education classes have been more difficult to conduct given the limitations of the setup. As such, exergaming has been identified as a possible educational tool that could improve students’ motivation, participation and fitness levels and reduce negative behaviours in class while contributing to the current curriculum.

Objectives

The study explores the perspectives of both the physical education academic staff and senior high school students from the University of Santo Tomas on the implementation of exergaming to determine the feasibility of exergaming as an educational tool in the Philippines’ physical education curriculum.

Methodology

A descriptive qualitative design will be used and participants will be selected through criterion sampling. The authors will conduct a process of question development and pilot FGDs beforehand to ensure smooth proceedings. Once done, they will undergo FGDs conducted through Google Meet. Data will be coded and analysed via thematic analysis using manual coding and NVivo V.12 software to summarise central themes and perceptions.

Ethics and dissemination

This study will abide by the Nuremberg Code, Declaration of Helsinki, Belmont Report, Data Privacy Act of 2012 and National Ethical Guidelines (for health-related research) of 2017. The study has received approval from the University of Santo Tomas (UST)-College of Rehabilitation Sciences (CRS) Ethics Review Committee. All participant data will be labelled according to random two-digit computer generated codes to preserve anonymity and stored in password-protected laptops and Google Drive folders to preserve confidentiality. Results will be made available to individual UST physical education academic staff and senior high school students prior to publication in peer-reviewed journal.

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.
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.

Measuring the success of programmes of care for people living with dementia: a protocol for consensus building with consumers to develop a set of Core Outcome Measures for Improving Care (COM-IC)

Por: Comans · T. · Nguyen · K. · Gray · L. · Flicker · L. · Williamson · P. · Dodd · S. · Kearney · A. · Cunningham · C. · Morris · T. · Nunn · J. · Trepel · D. · Almeida · O. P. · Kenny · D. · Welch · A. · Lowthian · J. A. · Quinn · J. · Petrie · G. · Dao-Tran · T.-H. · Manchha · A. · Kurrle · S.
Introduction

The Core Outcome Measures for Improving Care (COM-IC) project aims to deliver practical recommendations on the selection and implementation of a suite of core outcomes to measure the effectiveness of interventions for dementia care.

Methods and analysis

COM-IC embeds a participatory action approach to using the Alignment–Harmonisation–Results framework for measuring dementia care in Australia. Using this framework, suitable core outcome measures will be identified, analysed, implemented and audited. The methods for analysing each stage will be codesigned with stakeholders, through the conduit of a Stakeholder Reference Group including people living with dementia, formal and informal carers, aged care industry representatives, researchers, clinicians and policy actors. The codesigned evaluation methods consider two key factors: feasibility and acceptability. These considerations will be tested during a 6-month feasibility study embedded in aged care industry partner organisations.

Ethics and dissemination

COM-IC has received ethical approval from The University of Queensland (HREC 2021/HE001932). Results will be disseminated through networks established over the project, and in accordance with both the publication schedule and requests from the Stakeholder Reference Group. Full access to publications and reports will be made available through UQ eSpace (https://espace.library.uq.edu.au/), an open access repository hosted by The University of Queensland.

Quality of life in south-eastern Australia: normative values for the WHOQOL-BREF in a population-based sample of adults

Por: West · E. C. · Williams · L. J. · Stuart · A. L. · Pasco · J. A.
Objectives

The abbreviated World Health Organisation Quality of Life tool (WHOQOL-BREF) is a short-form quality of life (QoL) assessment commonly used worldwide in both healthy and ill populations. Normative data for the Australian general population are limited. The objective of this study was to present normative data for the WHOQOL-BREF based on a general population sample. A secondary aim was to explore sociodemographic factors related to QoL.

Design

Population-based cross-sectional study.

Participants

929 men and 830 women aged 24–94 years participating in the Geelong Osteoporosis Study.

Outcome measures

The 26-item WHOQOL-BREF.

Results

Means and SD for each domain are presented by age group and sex. Percentile scores were also generated. Mean scores for WHOQOL-BREF domains were 74.52 (SD=16.22) for physical health, 72.07 (SD=15.35) for psychological, 72.87 (SD=18.78) for social relationships and 79.68 (SD=12.55) for environment. We identified significant associations between sociodemographic factors and WHOQOL-BREF domains. Notably, being married or in a relationship was associated with increased odds for high QoL across all four WHOQOL-BREF domains: physical health (women OR 2.46, 95% CI 1.36 to 4.44, p=0.003), psychological (men OR 2.07, 95% CI: 1.20 to 3.55, p=0.009; women OR 2.15, 95% CI 1.21 to 3.81, p=0.009), social relationships (men OR 2.28, 95% CI 1.29 to 4.04, p=0.005; women OR 2.77, 95% CI 1.42 to 5.41, p=0.003) and environment (women OR 2.07, 95% CI 1.13 to 3.80, p=0.019).

Conclusions

This study provides population norms for the WHOQOL-BREF based on a representative sample of Australian adults. Our results will be useful to researchers and clinicians who can use these data as a reference point for interpreting WHOQOL-BREF scores.

How surgical Trainee Research Collaboratives achieve success: a mixed methods study to develop trainee engagement strategies

Por: Clement · C. · Coulman · K. · Heywood · N. · Pinkney · T. · Blazeby · J. · Blencowe · N. S. · Cook · J. A. · Bulbulia · R. · Arenas-Pinto · A. · Snowdon · C. · Hilton · Z. · Magill · L. · MacLennan · G. · Glasbey · J. · Nepogodiev · D. · Hardy · V. · Lane · J. A.
Objectives

This study aimed to understand the role of surgical Trainee Research Collaboratives (TRCs) in conducting randomised controlled trials and identify strategies to enhance trainee engagement in trials.

Design

This is a mixed methods study. We used observation of TRC meetings, semi-structured interviews and an online survey to explore trainees’ motivations for engagement in trials and TRCs, including barriers and facilitators. Interviews were analysed thematically, alongside observation field notes. Survey responses were analysed using descriptive statistics. Strategies to enhance TRCs were developed at a workshop by 13 trial methodologists, surgical trainees, consultants and research nurses.

Setting

This study was conducted within a secondary care setting in the UK.

Participants

The survey was sent to registered UK surgical trainees. TRC members and linked stakeholders across surgical specialties and UK regions were purposefully sampled for interviews.

Results

We observed 5 TRC meetings, conducted 32 semi-structured interviews and analysed 73 survey responses. TRCs can mobilise trainees thus gaining wider access to patients. Trainees engaged with TRCs to improve patient care, surgical evidence and to help progress their careers. Trainees valued the TRC infrastructure, research expertise and mentoring. Challenges for trainees included clinical and other priorities, limited time and confidence, and recognition, especially by authorship. Key TRC strategies were consultant support, initial simple rapid studies, transparency of involvement and recognition for trainees (including authorship policies) and working with Clinical Trials Units and research nurses. A 6 min digital story on YouTube disseminated these strategies.

Conclusion

Trainee surgeons are mostly motivated to engage with trials and TRCs. Trainee engagement in TRCs can be enhanced through building relationships with key stakeholders, maximising multi-disciplinary working and offering training and career development opportunities.

Psychological interventions for weight reduction and sustained weight reduction in adults with overweight and obesity: a scoping review protocol

Por: Hamer · O. · Bray · E. P. · Harris · C. · Blundell · A. · Kuroski · J. A. · Schneider · E. · Watkins · C. · Clegg · A.
Introduction

Overweight and obesity are growing public health problems worldwide. Both diet and physical activity have been the primary interventions for weight reduction over the past decade. With increasing rates of overweight and obesity, it is evident that a primary focus on diet and exercise has not resulted in sustained obesity reduction within the global population. There is now a case to explore other weight management strategies, focusing on psychological factors that may underpin overweight and obesity. Psychological therapy interventions are gaining recognition for their effectiveness in addressing underlying emotional factors and promoting weight loss. However, there is a dearth of literature that has mapped the types of psychological interventions and the characteristics of these interventions as a means of achieving weight reduction and sustained weight reduction in adults with overweight or obesity.

Methods and analysis

The review will combine the methodology outlined by Arksey and O’Malley with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. A total of six databases will be searched using a comprehensive search strategy. Intervention studies will be included if participants are 18 years and over, classified as overweight or obese (body mass index ≥25 kg/m2), and have received a psychological therapy intervention. The review will exclude studies that are not available in English, not full text, none peer reviewed or combine a lifestyle and/or pharmacological intervention with a psychological intervention. Data will be synthesised using a narrative synthesis approach.

Ethics and dissemination

Ethical approval is not required to conduct this scoping review. The findings will be disseminated through journal publication(s), social media and a lay summary for key stakeholders.

What are best practices for involving family caregivers in interventions aimed at responsive behaviour stemming from unmet needs of people with dementia in nursing homes: a scoping review

Objectives

This study aimed to determine best practices for involving family caregivers in interventions aimed at preventing and reducing responsive behaviour stemming from unmet needs, including pain.

Design

Scoping review, reported according to the Preferred Reporting Items for Systematic Reviews, Meta-Analyses extension for Scoping Reviews reporting guideline.

Data sources

PubMed, Embase, Emcare, Web of Science, COCHRANE Library, PsycINFO, Academic Search Premier and Cinahl searched up to 23 July 2023.

Eligibility criteria

Studies reporting on family involvement in interventions for nursing home residents with dementia were included.

Data extraction and synthesis

Two researchers independently extracted the data, followed by a content analysis.

Results

Of the 1486 records screened, 20 studies were included. Family caregivers were involved in interventions aimed at planning care, life review (eg, documentation of life experiences of their relative), and selecting activities for their relative. Family caregivers preferred an active role in developing optimal care for their relative. Drivers of success and barriers to family involvement centred around three themes: (1) communication between all involved; (2) prerequisites (organisational and other conditions) and (3) personal circumstances (family’s coping and skills).

Conclusion

Best practices for involving family caregivers in interventions aimed at addressing responsive behaviour in residents with dementia concerned those interventions in which family caregivers were given an important role in managing responsive behaviour. This means that, in order to achieve an active role of family caregivers in the whole care process, their needs must be taken into account.

Trial registration number

The protocol of the review was regisered at OSF; https://osf.io/twcfq

Using SUpported Motivational InTerviewing (SUMIT) to increase physical activity for people with knee osteoarthritis: a pilot, feasibility randomised controlled trial

Por: Bell · E. C. · O'Halloran · P. · Wallis · J. A. · Crossley · K. M. · Gibbs · A. J. · Lee · A. · Jennings · S. · Barton · C. J.
Objective

The objective of this study was to determine the feasibility and effectiveness of using SUpported Motivational InTerviewing (SUMIT) to increase physical activity in people with knee osteoarthritis (KOA).

Design

Randomised controlled trial.

Setting

We recruited people who had completed Good Life with osteoArthritis Denmark (GLA:D) from private, public and community settings in Victoria, Australia.

Interventions

Participants were randomised participants to receive SUMIT or usual care. SUMIT comprised five motivational interviewing sessions targeting physical activity over 10 weeks, and access to a multimedia web-based platform.

Participants

Thirty-two participants were recruited (17 SUMIT, 15 control) including 22 females (69%).

Outcome measures

Feasibility outcomes included recruitment rate, adherence to motivational interviewing, ActivPAL wear and drop-out rate. Effect sizes (ESs) were calculated for daily steps, stepping time, time with cadence >100 steps per minute, time in bouts >1 min; 6 min walk distance, Knee Osteoarthritis Outcome Score (KOOS) subscales (pain, symptoms, function, sport and recreation, and quality of life (QoL)), Euroqual, systolic blood pressure, body mass index, waist circumference, 30 s chair stand test and walking speed during 40 m walk test.

Results

All feasibility criteria were achieved, with 32/63 eligible participants recruited over seven months; with all participants adhering to all motivational interviewing calls and achieving sufficient ActivPAL wear time, and only two drop-outs (6%).

12/15 outcome measures showed at least a small effect (ES>0.2) favouring the SUMIT group, including daily time with cadence >100 steps per minute (ES=0.43). Two outcomes, walking speed (ES= 0.97) and KOOS QoL (ES=0.81), showed a large effect (ES>0.8).

Conclusion

SUMIT is feasible in people with knee osteoarthritis. Potential benefits included more time spent walking at moderate intensity, faster walking speeds and better QoL.

Trial registration number

ACTRN12621000267853.

Dynamic changes in methadone utilisation for opioid use disorder treatment: a retrospective observational study during the COVID-19 pandemic

Por: Kennalley · A. L. · Fanelli · J. L. · Furst · J. A. · Mynarski · N. J. · Jarvis · M. A. · Nichols · S. D. · McCall · K. L. · Piper · B. J.
Objectives

Opioid use disorder (OUD) is a major public health concern in the USA, resulting in high rates of overdose and other negative outcomes. Methadone, an OUD treatment, has been shown to be effective in reducing the risk of overdose and improving overall health and quality of life. This study analysed the distribution of methadone for the treatment of OUD across the USA over the past decade and through the COVID-19 pandemic.

Design

Retrospective observational study using secondary data analysis of the Drug Enforcement Administration and Medicaid Databases.

Setting

USA.

Participants

Patients who were dispensed methadone at US opioid treatment programmes (OTPs).

Primary and secondary outcome measures

The primary outcomes were the overall pattern in methadone distribution and the number of OTPs in the USA per year. The secondary outcome was Medicaid prescriptions for methadone.

Results

Methadone distribution for OUD has expanded significantly over the past decade, with an average state increase of +96.96% from 2010 to 2020. There was a significant increase in overall distribution of methadone to OTP from 2010 to 2020 (+61.00%, p

Conclusions

There have been dynamic changes in methadone distribution for OUD. Furthermore, pronounced variation in methadone distribution among states was observed, with some states having no OTPs or Medicaid coverage. New policies are urgently needed to increase access to methadone treatment, address the opioid epidemic in the USA and reduce overdose deaths.

Developing and externally validating a machine learning risk prediction model for 30-day mortality after stroke using national stroke registers in the UK and Sweden

Por: Wang · W. · Otieno · J. A. · Eriksson · M. · Wolfe · C. D. · Curcin · V. · Bray · B. D.
Objectives

We aimed to develop and externally validate a generalisable risk prediction model for 30-day stroke mortality suitable for supporting quality improvement analytics in stroke care using large nationwide stroke registers in the UK and Sweden.

Design

Registry-based cohort study.

Setting

Stroke registries including the Sentinel Stroke National Audit Programme (SSNAP) in England, Wales and Northern Ireland (2013–2019) and the national Swedish stroke register (Riksstroke 2015–2020).

Participants and methods

Data from SSNAP were used for developing and temporally validating the model, and data from Riksstroke were used for external validation. Models were developed with the variables available in both registries using logistic regression (LR), LR with elastic net and interaction terms and eXtreme Gradient Boosting (XGBoost). Performances were evaluated with discrimination, calibration and decision curves.

Outcome measures

The primary outcome was all-cause 30-day in-hospital mortality after stroke.

Results

In total, 488 497 patients who had a stroke with 12.4% 30-day in-hospital mortality were used for developing and temporally validating the model in the UK. A total of 128 360 patients who had a stroke with 10.8% 30-day in-hospital mortality and 13.1% all mortality were used for external validation in Sweden. In the SSNAP temporal validation set, the final XGBoost model achieved the highest area under the receiver operating characteristic curve (AUC) (0.852 (95% CI 0.848 to 0.855)) and was well calibrated. The performances on the external validation in Riksstroke were as good and achieved AUC at 0.861 (95% CI 0.858 to 0.865) for in-hospital mortality. For Riksstroke, the models slightly overestimated the risk for in-hospital mortality, while they were better calibrated at the risk for all mortality.

Conclusion

The risk prediction model was accurate and externally validated using high quality registry data. This is potentially suitable to be deployed as part of quality improvement analytics in stroke care to enable the fair comparison of stroke mortality outcomes across hospitals and health systems across countries

Self-collected samples as an additional option for STI testing in low-resource settings: a qualitative study of acceptability among adults in Rakai, Uganda

Por: Ogale · Y. P. · Grabowski · M. K. · Nabakka · P. · Ddaaki · W. · Nakubulwa · R. · Nakyanjo · N. · Nalugoda · F. · Kagaayi · J. · Kigozi · G. · Denison · J. A. · Gaydos · C. · Kennedy · C. E.
Introduction

Self-collected samples (SCS) for sexually transmitted infection (STI) testing have been shown to be feasible and acceptable in high-resource settings. However, few studies have assessed the acceptability of SCS for STI testing in a general population in low-resource settings. This study explored the acceptability of SCS among adults in south-central Uganda.

Methods

Nested within the Rakai Community Cohort Study, we conducted semistructured interviews with 36 adults who SCS for STI testing. We analysed the data using an adapted version of the Framework Method.

Results

Overall, SCS was acceptable to both male and female participants, regardless of whether they reported recent STI symptoms. Perceived advantages of SCS over provider-collection included increased privacy and confidentiality, gentleness and efficiency. Disadvantages included the lack of provider involvement, fear of self-harm and the perception that SCS was unhygienic. Most participants preferred provider-collected samples to SCS. Nevertheless, almost all said they would recommend SCS and would do it again in the future.

Conclusion

SCS are acceptable among adults in this low-resource setting and could be offered as an additional option to expand STI diagnostic services.

Shaping care home COVID-19 testing policy: a protocol for a pragmatic cluster randomised controlled trial of asymptomatic testing compared with standard care in care home staff (VIVALDI-CT)

Por: Adams · N. · Stirrup · O. · Blackstone · J. · Krutikov · M. · Cassell · J. A. · Cadar · D. · Henderson · C. · Knapp · M. · Gosce · L. · Leiser · R. · Regan · M. · Cullen-Stephenson · I. · Fenner · R. · Verma · A. · Gordon · A. · Hopkins · S. · Copas · A. · Freemantle · N. · Flowers · P. · Sh
Introduction

Care home residents have experienced significant morbidity, mortality and disruption following outbreaks of SARS-CoV-2. Regular SARS-CoV-2 testing of care home staff was introduced to reduce transmission of infection, but it is unclear whether this remains beneficial. This trial aims to investigate whether use of regular asymptomatic staff testing, alongside funding to reimburse sick pay for those who test positive and meet costs of employing agency staff, is a feasible and effective strategy to reduce COVID-19 impact in care homes.

Methods and analysis

The VIVALDI-Clinical Trial is a multicentre, open-label, cluster randomised controlled, phase III/IV superiority trial in up to 280 residential and/or nursing homes in England providing care to adults aged >65 years. All regular and agency staff will be enrolled, excepting those who opt out. Homes will be randomised to the intervention arm (twice weekly asymptomatic staff testing for SARS-CoV-2) or the control arm (current national testing guidance). Staff who test positive for SARS-CoV-2 will self-isolate and receive sick pay. Care providers will be reimbursed for costs associated with employing temporary staff to backfill for absence arising directly from the trial.

The trial will be delivered by a multidisciplinary research team through a series of five work packages.

The primary outcome is the incidence of COVID-19-related hospital admissions in residents. Secondary outcomes include the number and duration of outbreaks and home closures. Health economic and modelling analyses will investigate the cost-effectiveness and cost consequences of the testing intervention. A process evaluation using qualitative interviews will be conducted to understand intervention roll out and identify areas for optimisation to inform future intervention scale-up, should the testing approach prove effective and cost-effective. Stakeholder engagement will be undertaken to enable the sector to plan for results and their implications and to coproduce recommendations on the use of testing for policy-makers.

Ethics and dissemination

The study has been approved by the London—Bromley Research Ethics Committee (reference number 22/LO/0846) and the Health Research Authority (22/CAG/0165). The results of the trial will be disseminated regardless of the direction of effect. The publication of the results will comply with a trial-specific publication policy and will include submission to open access journals. A lay summary of the results will also be produced to disseminate the results to participants.

Trial registration number

ISRCTN13296529.

Scabies outbreak management in refugee/migrant camps in Europe 2014-2017: a retrospective qualitative interview study of healthcare staff experiences and perspectives

Por: Richardson · N. A. · Cassell · J. A. · Head · M. G. · Lanza · S. · Schaefer · C. · Walker · S. L. · Middleton · J.
Objectives

Provide insights into the experiences and perspectives of healthcare staff who treated scabies or managed outbreaks in formal and informal refugee/migrant camps in Europe 2014–2017.

Design

Retrospective qualitative study using semistructured telephone interviews and framework analysis. Recruitment was done primarily through online networks of healthcare staff involved in medical care in refugee/migrant settings.

Setting

Formal and informal refugee/migrant camps in Europe 2014–2017.

Participants

Twelve participants (four doctors, four nurses, three allied health workers, one medical student) who had worked in camps (six in informal camps, nine in formal ones) across 15 locations within seven European countries (Greece, Serbia, Macedonia, Turkey, France, the Netherlands, Belgium).

Results

Participants reported that in camps they had worked, scabies diagnosis was primarily clinical (without dermatoscopy), and treatment and outbreak management varied highly. Seven stated scabicides were provided, while five reported that only symptomatic management was offered. They described camps as difficult places to work, with poor living standards for residents. Key perceived barriers to scabies control were (1) lack of water, sanitation and hygiene, specifically: absent/limited showers (difficult to wash off topical scabicides), and inability to wash clothes and bedding (may have increased transmission/reinfestation); (2) social factors: language, stigma, treatment non-compliance and mobility (interfering with contact tracing and follow-up treatments); (3) healthcare factors: scabicide shortages and diversity, lack of examination privacy and staff inexperience; (4) organisational factors: overcrowding, ineffective interorganisational coordination, and lack of support and maltreatment by state authorities (eg, not providing basic facilities, obstruction of self-care by camp residents and non-governmental organisation (NGO) aid).

Conclusions

We recommend development of accessible scabies guidelines for camps, use of consensus diagnostic criteria and oral ivermectin mass treatments. In addition, as much of the work described was by small, volunteer-staffed NGOs, we in the wider healthcare community should reflect how to better support such initiatives and those they serve.

Intranasal antihistamines and corticosteroids in the treatment of allergic rhinitis: a systematic review and meta-analysis protocol

Por: Sousa-Pinto · B. · Vieira · R. J. · Brozek · J. · Cardoso-Fernandes · A. · Lourenco-Silva · N. · Ferreira-da-Silva · R. · Ferreira · A. · Gil-Mata · S. · Bedbrook · A. · Klimek · L. · Fonseca · J. A. · Zuberbier · T. · Schünemann · H. J. · Bousquet · J.
Introduction

Intranasal antihistamines and corticosteroids are some of the most frequently used drug classes in the treatment of allergic rhinitis. However, there is uncertainty as to whether effectiveness differences may exist among different intranasal specific medications. This systematic review aims to analyse and synthesise all evidence from randomised controlled trials (RCTs) on the effectiveness of intranasal antihistamines and corticosteroids in rhinitis nasal and ocular symptoms and in rhinoconjunctivitis-related quality-of-life.

Methods and analysis

We will search four electronic bibliographic databases and three clinical trials databases for RCTs (1) assessing patients ≥12 years old with seasonal or perennial allergic rhinitis and (2) comparing the use of intranasal antihistamines or corticosteroids versus placebo. Assessed outcomes will include the Total Nasal Symptom Score (TNSS), the Total Ocular Symptom Score (TOSS) and the Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ). We will assess the methodological quality of included primary studies by using the Cochrane risk-of-bias tool. Certainty in the body of evidence for the analysed outcomes will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. We will perform a random-effects meta-analysis for each assessed medication and outcome, presenting results as pooled mean differences and standardised mean differences. Heterogeneity will be explored by sensitivity and subgroup analyses, considering (1) the risk of bias, (2) the follow-up period and (3) the drug dose.

Ethics and dissemination

Ethical considerations will not be required. Results will be disseminated in a peer-review journal.

PROSPERO registration number

CRD42023416573.

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