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AnteayerBMJ Open

Study protocol: improving response to malaria in the Amazon through identification of inter-community networks and human mobility in border regions of Ecuador, Peru and Brazil

Por: Janko · M. M. · Araujo · A. L. · Ascencio · E. J. · Guedes · G. R. · Vasco · L. E. · Santos · R. O. · Damasceno · C. P. · Medrano · P. G. · Chacon-Uscamaita · P. R. · Gunderson · A. K. · OMalley · S. · Kansara · P. H. · Narvaez · M. B. · Coombes · C. · Pizzitutti · F. · Salmon-Mulano
Introduction

Understanding human mobility’s role in malaria transmission is critical to successful control and elimination. However, common approaches to measuring mobility are ill-equipped for remote regions such as the Amazon. This study develops a network survey to quantify the effect of community connectivity and mobility on malaria transmission.

Methods

We measure community connectivity across the study area using a respondent driven sampling design among key informants who are at least 18 years of age. 45 initial communities will be selected: 10 in Brazil, 10 in Ecuador and 25 in Peru. Participants will be recruited in each initial node and administered a survey to obtain data on each community’s mobility patterns. Survey responses will be ranked and the 2–3 most connected communities will then be selected and surveyed. This process will be repeated for a third round of data collection. Community network matrices will be linked with each country’s malaria surveillance system to test the effects of mobility on disease risk.

Ethics and dissemination

This study protocol has been approved by the institutional review boards of Duke University (USA), Universidad San Francisco de Quito (Ecuador), Universidad Peruana Cayetano Heredia (Peru) and Universidade Federal Minas Gerais (Brazil). Results will be disseminated in communities by the end of the study.

Artificial intelligence-based prediction of diabetic retinopathy evolution (EviRed): protocol for a prospective cohort

Por: Tadayoni · R. · Massin · P. · Bonnin · S. · Magazzeni · S. · Lay · B. · Le Guilcher · A. · Vicaut · E. · Couturier · A. · Quellec · G. · Investigators · E.
Introduction

An important obstacle in the fight against diabetic retinopathy (DR) is the use of a classification system based on old imaging techniques and insufficient data to accurately predict its evolution. New imaging techniques generate new valuable data, but we lack an adapted classification based on these data. The main objective of the Evaluation Intelligente de la Rétinopathie Diabétique, Intelligent evaluation of DR (EviRed) project is to develop and validate a system assisting the ophthalmologist in decision-making during DR follow-up by improving the prediction of its evolution.

Methods and analysis

A cohort of up to 5000 patients with diabetes will be recruited from 18 diabetology departments and 14 ophthalmology departments, in public or private hospitals in France and followed for an average of 2 years. Each year, systemic health data as well as ophthalmological data will be collected. Both eyes will be imaged by using different imaging modalities including widefield photography, optical coherence tomography (OCT) and OCT-angiography. The EviRed cohort will be divided into two groups: one group will be randomly selected in each stratum during the inclusion period to be representative of the general diabetic population. Their data will be used for validating the algorithms (validation cohort). The data for the remaining patients (training cohort) will be used to train the algorithms.

Ethics and dissemination

The study protocol was approved by the French South-West and Overseas Ethics Committee 4 on 28 August 2020 (CPP2020-07-060b/2020-A01725-34/20.06.16.41433). Prior to the start of the study, each patient will provide a written informed consent documenting his or her agreement to participate in the clinical trial. Results of this research will be disseminated in peer-reviewed publications and conference presentations. The database will also be available for further study or development that could benefit patients.

Trial registration number

NCT04624737

Do patients with type 2 diabetes mellitus included in randomised clinical trials differ from general-practice patients? A cross-sectional comparative study

Por: Dugard · A. · Giraudeau · B. · Dibao-Dina · C.
Objectives

To compare the characteristics of patients with type 2 diabetes mellitus in general practice and those included in randomised controlled trials on which clinical practice guidelines are based.

Design

Cross-sectional comparative study.

Setting

We asked 45 general practitioners from three French Departments to identify the 15 patients with type 2 diabetes mellitus they most recently saw in consultation. In parallel, we selected randomised controlled trials included in the Cochrane systematic review on which the clinical practice guidelines for type 2 diabetes mellitus were based.

Participants

We included 675 patients with type 2 diabetes mellitus, and data were collected from 23 randomised controlled trials, corresponding to 36 059 patients.

Outcome measures

Characteristics of general-practice patients were extracted from medical records by a unique observer. The same baseline characteristics of patients included in randomised controlled trials from the Cochrane systematic review were extracted and meta-analysed. We assessed standardised differences between these two series of baseline characteristics. A difference greater than 0.10 in absolute value was considered meaningful.

Results

General-practice patients were older than randomised controlled trial patients (mean (SD) 68.8 (1.1) vs 59.9 years (standardised difference 0.8)) and had a higher body mass index (mean (SD) 31.5 (6.9) vs 28.2 kg/m2 (standardised difference 0.5)) but smoked less (11.0% vs 29.3% (standardised difference –0.6)). They more frequently used antihypertensive drugs (82.1% vs 37.5% (standardised difference 1.2)) but less frequently had a myocardial infarction (7.6% vs 23.1% (standardised difference –1.1)).

Conclusions

Patients with type 2 diabetes mellitus cared for in general practice differ in a number of important aspects from patients included in randomised controlled trials on which clinical practice guidelines are based. This situation hampers the applicability of these guidelines. Future randomised trials should include patients who better fit the ‘average’ general-practice patient with type 2 diabetes mellitus to help improve the translation of study findings in daily practice.

Understanding lived experiences and perceptions of resilience in black and South Asian Muslim children living in East London: a qualitative study protocol

Por: Murray · A. · Durrani · F. · Winstanley · A. · Keiller · E. · Taleb · P. A. · Islam · S. · Foka · S. · Turri · M. G. · Lau · J. Y. F.
Introduction

It is important to promote resilience in preadolescence; however, there is limited research on children’s understandings and experiences of resilience. Quantitative approaches may not capture dynamic and context-specific aspects of resilience. Resilience research has historically focused on white, middle-class Western adults and adolescents, creating an evidence gap regarding diverse experiences of resilience in middle childhood which could inform interventions. East London’s Muslim community represents a diverse, growing population. Despite being disproportionately affected by deprivation and racial and cultural discrimination, this population is under-represented in resilience research. Using participatory and arts-based methods, this study aims to explore lived experiences and perceptions of resilience in black and South Asian Muslim children living in East London.

Methods and analysis

We propose a qualitative study, grounded in embodied inquiry, consisting of a participatory workshop with 6–12 children and their parents/carers to explore lived experiences and perceptions of resilience. Participants will be identified and recruited from community settings in East London. Eligible participants will be English-speaking Muslims who identify as being black or South Asian, have a child aged 8–12 years and live in East London. The workshop (approx. 3.5 hours) will take place at an Islamic community centre and will include body mapping with children and a focus group discussion with parents/carers to explore resilience perspectives and meanings. Participants will also complete a demographic survey. Workshop audio recordings will be transcribed verbatim and body maps and other paper-based activities will be photographed. Data will be analysed using systematic visuo-textual analysis which affords equal importance to visual and textual data.

Ethics and dissemination

The Queen Mary Ethics of Research Committee at Queen Mary University of London has approved this study (approval date: 9 October 2023; ref: QME23.0042). The researchers plan to publish the results in peer-reviewed journals and present findings at academic conferences.

Further development and validation of the Multimorbidity Treatment Burden Questionnaire (MTBQ)

Por: Duncan · P. · Scott · L. J. · Dawson · S. · Munas · M. · Pyne · Y. · Chaplin · K. · Gaunt · D. · Guenette · L. · Salisbury · C.
Objectives

To undertake further psychometric testing of the Multimorbidity Treatment Burden Questionnaire (MTBQ) and examine whether reversing the scale reduced floor effects.

Design

Survey.

Setting

UK primary care.

Participants

Adults (≥18 years) with three or more long-term conditions randomly selected from four general practices and invited by post.

Measures

Baseline survey: sociodemographics, MTBQ (original or version with scale reversed), Treatment Burden Questionnaire (TBQ), four questions (from QQ-10) on ease of completing the questionnaires. Follow-up survey (1–4 weeks after baseline): MTBQ, TBQ and QQ-10. Anonymous data collected from electronic GP records: consultations (preceding 12 months) and long-term conditions. The proportion of missing data and distribution of responses were examined for the original and reversed versions of the MTBQ and the TBQ. Intraclass correlation coefficient (ICC) and Spearman’s rank correlation (Rs) assessed test–retest reliability and construct validity, respectively. Ease of completing the MTBQ and TBQ was compared. Interpretability was assessed by grouping global MTBQ scores into 0 and tertiles (>0).

Results

244 adults completed the baseline survey (consent rate 31%, mean age 70 years) and 225 completed the follow-up survey. Reversing the scale did not reduce floor effects or data skewness. The global MTBQ scores had good test–retest reliability (ICC for agreement at baseline and follow-up 0.765, 95% CI 0.702 to 0.816). Global MTBQ score was correlated with global TBQ score (Rs 0.77, ps 0.17, p=0.010), and number of different general practitioners consulted (Rs 0.23, ps –0.063, p=0.330). Most participants agreed that both the MTBQ and TBQ were easy to complete and included aspects they were concerned about.

Conclusion

This study demonstrates test–retest reliability and ease of completion of the MTBQ and builds on a previous study demonstrating good content validity, construct validity and internal consistency reliability of the questionnaire.

Qualitative study exploring the design of a patient-reported symptom-based risk stratification system for suspected head and neck cancer referrals: protocol for work packages 1 and 2 within the EVEREST-HN programme

Por: Albutt · A. · Hardman · J. · McVey · L. · Odo · C. · Paleri · V. · Patterson · J. · Webb · S. · Rousseau · N. · Kellar · I. · Randell · R.
Introduction

Between 2009/2010 and 2019/2020, England witnessed an increase in suspected head and neck cancer (sHNC) referrals from 140 to 404 patients per 100 000 population. 1 in 10 patients are not seen within the 2-week target, contributing to patient anxiety. We will develop a pathway for sHNC referrals, based on the Head and Neck Cancer Risk Calculator. The evolution of a patient-reported symptom-based risk stratification system to redesign the sHNC referral pathway (EVEREST-HN) Programme comprises six work packages (WPs). This protocol describes WP1 and WP2. WP1 will obtain an understanding of language to optimise the SYmptom iNput Clinical (SYNC) system patient-reported symptom questionnaire for sHNC referrals and outline requirements for the SYNC system. WP2 will codesign key elements of the SYNC system, including the SYNC Questionnaire, and accompanying behaviour change materials.

Methods and analysis

WP1 will be conducted at three acute National Health Service (NHS) trusts with variation in service delivery models and ensuring a broad mixture of social, economic and cultural backgrounds of participants. Up to 150 patients with sHNC (n=50 per site) and 15 clinicians (n=5 per site) will be recruited. WP1 will use qualitative methods including interviews, observation and recordings of consultations. Rapid qualitative analysis and inductive thematic analysis will be used to analyse the data. WP2 will recruit lay patient representatives to participate in online focus groups (n=8 per focus group), think-aloud technique and experience-based codesign and will be analysed using qualitative and quantitative approaches.

Ethics and dissemination

The committee for clinical research at The Royal Marsden, a research ethics committee and the Health Research Authority approved this protocol. All participants will give informed consent. Ethical issues of working with patients on an urgent cancer diagnostic pathway have been considered. Findings will be disseminated via journal publications, conference presentations and public engagement activities.

Comparing nurses attending a specialised mental health programme with and without substance use disorder: a retrospective, observational study in Spain

Por: Braquehais · M. D. · Mozo · X. · Llavayol · E. · Gausachs · E. · Santiago · R. · Nieva · G. · Valero · S. · Grau-Lopez · L. · Ramos-Quiroga · J. A. · Bruguera · E.
Objectives

To analyse the differences between nurses with and without substance use disorders (SUDs) admitted to a specialised mental health programme.

Design

Retrospective, observational study.

Setting

Specialised mental health treatment programme for nurses in Catalonia, Spain.

Participants

1091 nurses admitted to the programme from 2000 to 2021.

Interventions

None.

Primary and secondary outcomes

Sociodemographic, occupational and clinical variables were analysed. Diagnoses followed Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision criteria.

Results

Most nurses admitted to the programme were women (88%, n=960) and came voluntarily (92.1%, n=1005). The mean age at admission was 45 (SD=10.4) years. The most common diagnoses were adjustment disorders (36.6%, n=399), unipolar mood disorders (25.8%, n=282), anxiety disorders (16.4%, n=179) and SUDs (13.8%, n=151). Only 19.2% (n=209) of the sample were hospitalised during their first treatment episode. After multivariate analysis, suffering from a SUD was significantly associated with being a man (OR=4.12; 95% CI 2.49 to 6.82), coming after a directed referral (OR=4.55; 95% CI 2.5 to 7.69), being on sick leave at admission (OR=2.21; 95% CI 1.42 to 3.45) and needing hospitalisation at the beginning of their treatment (OR=12.5; 95% CI 8.3 to 20).

Conclusions

Nurses with SUDs have greater resistance to voluntarily asking for help from specialised mental health treatment programmes and have greater clinical severity compared with those without addictions. SUDs are also more frequent among men. More actions are needed to help prevent and promote earlier help-seeking behaviours among nurses with this type of mental disorder.

Study protocol for a type-II hybrid effectiveness-implementation trial to reach teenagers using mobile money shops to reduce unintended pregnancies in Uganda

Por: Komasawa · M. · Sato · M. · Ssekitoleko · R. · Waiswa · P. · Gitta · S. · Nabugoomu · J. · Honda · S. · Saito · K. · Aung · M. N.
Introduction

Unintended teenage pregnancies have become a global public health challenge, particularly in sub-Saharan Africa. There is a notably high prevalence of unintended pregnancies among unmarried teenagers in Uganda. This study will develop an intervention programme using mobile money shops (vendors) as a platform to deliver sexual and reproductive health and rights (SRHR) services to teenagers and assess its effectiveness and scalability in Uganda.

Methods and analyses

This hybrid study comprises two integral components: an intervention study to assess the effectiveness of vendor-mediated intervention and implementation research to evaluate the implementation process. 30 vendors will be recruited for both intervention and control arms in 2 municipalities in Eastern Uganda, which have a high unintended pregnancy prevalence rate among unmarried teens aged 15–19 years. A preintervention and postintervention repeated survey involving 600 participants for each arm will be conducted over 4 months. The primary outcome is the rate of condom users among teenage vendor users. The secondary outcomes include the rate of preference for receiving SRHR services at vendors and knowledge regarding SRHR. A difference-in-differences analysis will be used to determine the effectiveness of the intervention. The Bowen model will be employed to evaluate the implementation design.

Ethics and dissemination

Ethical approval was obtained from the Ethics Review Committee of Uganda Christen University and JICA Ogata Sadako Research Institute for Peace and Development in Japan. The findings will be widely disseminated. This study was registered with the University Hospital Medical Information Network in Japan (UMIN000053332) on 12 January 2024.

Trial registration number

UMIN000053332.

Hepatopancreaticobiliary Resection Arginine Immunomodulation (PRIMe) trial: protocol for a randomised phase II trial of the impact of perioperative immunomodulation on immune function following resection for hepatopancreaticobiliary malignancy

Por: Behman · R. · Auer · R. C. · Bubis · L. · Xu · G. · Coburn · N. G. · Martel · G. · Hallet · J. · Balaa · F. · Law · C. · Bertens · K. A. · Abou Khalil · J. · Karanicolas · P. J.
Introduction

Surgical stress results in immune dysfunction, predisposing patients to infections in the postoperative period and potentially increasing the risk of cancer recurrence. Perioperative immunonutrition with arginine-enhanced diets has been found to potentially improve short-term and cancer outcomes. This study seeks to measure the impact of perioperative immunomodulation on biomarkers of the immune response and perioperative outcomes following hepatopancreaticobiliary surgery.

Methods and analysis

This is a 1:1:1 randomised, controlled and blinded superiority trial of 45 patients. Baseline and perioperative variables were collected to evaluate immune function, clinical outcomes and feasibility outcomes. The primary outcome is a reduction in natural killer cell killing as measured on postoperative day 1 compared with baseline between the control and experimental cohorts.

Ethics and dissemination

This trial has been approved by the research ethics boards at participating sites and Health Canada (parent control number: 223646). Results will be distributed widely through local and international meetings, presentation, publication and ClinicalTrials.gov (identifier: NCT04549662). Any modifications to the protocol will be communicated via publications and ClinicalTrials.gov.

Trial registration number

ClinicalTrials.gov identifier: NCT04549662.

Perioperative mental health intervention for depression and anxiety symptoms in older adults study protocol: design and methods for three linked randomised controlled trials

Por: Holzer · K. J. · Bartosiak · K. A. · Calfee · R. P. · Hammill · C. W. · Haroutounian · S. · Kozower · B. D. · Cordner · T. A. · Lenard · E. M. · Freedland · K. E. · Tellor Pennington · B. R. · Wolfe · R. C. · Miller · J. P. · Politi · M. C. · Zhang · Y. · Yingling · M. D. · Baumann
Introduction

Preoperative anxiety and depression symptoms among older surgical patients are associated with poor postoperative outcomes, yet evidence-based interventions for anxiety and depression have not been applied within this setting. We present a protocol for randomised controlled trials (RCTs) in three surgical cohorts: cardiac, oncological and orthopaedic, investigating whether a perioperative mental health intervention, with psychological and pharmacological components, reduces perioperative symptoms of depression and anxiety in older surgical patients.

Methods and analysis

Adults ≥60 years undergoing cardiac, orthopaedic or oncological surgery will be enrolled in one of three-linked type 1 hybrid effectiveness/implementation RCTs that will be conducted in tandem with similar methods. In each trial, 100 participants will be randomised to a remotely delivered perioperative behavioural treatment incorporating principles of behavioural activation, compassion and care coordination, and medication optimisation, or enhanced usual care with mental health-related resources for this population. The primary outcome is change in depression and anxiety symptoms assessed with the Patient Health Questionnaire-Anxiety Depression Scale from baseline to 3 months post surgery. Other outcomes include quality of life, delirium, length of stay, falls, rehospitalisation, pain and implementation outcomes, including study and intervention reach, acceptability, feasibility and appropriateness, and patient experience with the intervention.

Ethics and dissemination

The trials have received ethics approval from the Washington University School of Medicine Institutional Review Board. Informed consent is required for participation in the trials. The results will be submitted for publication in peer-reviewed journals, presented at clinical research conferences and disseminated via the Center for Perioperative Mental Health website.

Trial registration numbers

NCT05575128, NCT05685511, NCT05697835, pre-results.

Inter-facility transfers for emergency obstetrical and neonatal care in rural Madagascar: a cost-effectiveness analysis

Por: Franke · M. A. · Nordmann · K. · Frühauf · A. · Ranaivoson · R. M. · Rebaliha · M. · Rapanjato · Z. · Bärnighausen · T. · Muller · N. · Knauss · S. · Emmrich · J. V.
Context

There is a substantial lack of inter-facility referral systems for emergency obstetrical and neonatal care in rural areas of sub-Saharan Africa. Data on the costs and cost-effectiveness of such systems that reduce preventable maternal and neonatal deaths are scarce.

Setting

We aimed to determine the cost-effectiveness of a non-governmental organisation (NGO)-run inter-facility referral system for emergency obstetrical and neonatal care in rural Southern Madagascar by analysing the characteristics of cases referred through the intervention as well as its costs.

Design

We used secondary NGO data, drawn from an NGO’s monitoring and financial administration database, including medical and financial records.

Outcome measures

We performed a descriptive and a cost-effectiveness analysis, including a one-way deterministic sensitivity analysis.

Results

1172 cases were referred over a period of 4 years. The most common referral reasons were obstructed labour, ineffective labour and eclampsia. In total, 48 neonates were referred through the referral system over the study period. Estimated cost per referral was US$336 and the incremental cost-effectiveness ratio (ICER) was US$70 per additional life-year saved (undiscounted, discounted US$137). The sensitivity analysis showed that the intervention was cost-effective for all scenarios with the lowest ICER at US$99 and the highest ICER at US$205 per additional life-year saved. When extrapolated to the population living in the study area, the investment costs of the programme were US$0.13 per person and annual running costs US$0.06 per person.

Conclusions

In our study, the inter-facility referral system was a very cost-effective intervention. Our findings may inform policies, decision-making and implementation strategies for emergency obstetrical and neonatal care referral systems in similar resource-constrained settings.

Prospective cohort study of genomic newborn screening: BabyScreen+ pilot study protocol

Por: Lunke · S. · Bouffler · S. E. · Downie · L. · Caruana · J. · Amor · D. J. · Archibald · A. · Bombard · Y. · Christodoulou · J. · Clausen · M. · De Fazio · P. · Greaves · R. F. · Hollizeck · S. · Kanga-Parabia · A. · Lang · N. · Lynch · F. · Peters · R. · Sadedin · S. · Tutty · E. · Eggers
Introduction

Newborn bloodspot screening (NBS) is a highly successful public health programme that uses biochemical and other assays to screen for severe but treatable childhood-onset conditions. Introducing genomic sequencing into NBS programmes increases the range of detectable conditions but raises practical and ethical issues. Evidence from prospectively ascertained cohorts is required to guide policy and future implementation. This study aims to develop, implement and evaluate a genomic NBS (gNBS) pilot programme.

Methods and analysis

The BabyScreen+ study will pilot gNBS in three phases. In the preimplementation phase, study materials, including education resources, decision support and data collection tools, will be designed. Focus groups and key informant interviews will also be undertaken to inform delivery of the study and future gNBS programmes. During the implementation phase, we will prospectively recruit birth parents in Victoria, Australia, to screen 1000 newborns for over 600 severe, treatable, childhood-onset conditions. Clinically accredited whole genome sequencing will be performed following standard NBS using the same sample. High chance results will be returned by genetic healthcare professionals, with follow-on genetic and other confirmatory testing and referral to specialist services as required. The postimplementation phase will evaluate the feasibility of gNBS as the primary aim, and assess ethical, implementation, psychosocial and health economic factors to inform future service delivery.

Ethics and dissemination

This project received ethics approval from the Royal Children’s Hospital Melbourne Research Ethics Committee: HREC/91500/RCHM-2023, HREC/90929/RCHM-2022 and HREC/91392/RCHM-2022. Findings will be disseminated to policy-makers, and through peer-reviewed journals and conferences.

Metabolic dysfunction-associated profiles and subsequent site-specific risk of obesity-related cancers among Chinese patients with diabetes: a retrospective cohort study

Por: Yau · S. T. Y. · Leung · E. · Wong · M. C. S. · Hung · C. T. · Chong · K. C. · Lee · A. · Yeoh · E. K.
Objectives

To compare metabolic dysfunction-associated profiles between patients with diabetes who developed different obesity-related site-specific cancers and those who remained free of cancer during follow-up.

Design

Retrospective cohort study.

Setting

Public general outpatient clinics in Hong Kong.

Participants

Patients with diabetes without a history of malignancy (n=391 921).

Primary outcome measures

The outcomes of interest were diagnosis of site-specific cancers (colon and rectum, liver, pancreas, bladder, kidney and stomach) during follow-up. Cox proportional hazards regression was applied to assess the associations between metabolic dysfunction and other clinical factors with each site-specific cancer.

Results

Each 0.1 increase in waist-to-hip ratio was associated with an 11%–35% elevated risk of colorectal, bladder and liver cancers. Each 1% increase in glycated haemoglobin was linked to a 4%–9% higher risk of liver and pancreatic cancers. While low-density lipoprotein cholesterol and triglycerides were inversely associated with the risk of liver and pancreatic cancers, high-density lipoprotein cholesterol was negatively associated with pancreatic, gastric and kidney cancers, but positively associated with liver cancer. Furthermore, liver cirrhosis was linked to a 56% increased risk of pancreatic cancer. No significant association between hypertension and cancer risk was found.

Conclusions

Metabolic dysfunction-associated profiles contribute to different obesity-related cancer outcomes differentially among patients with diabetes. This study may provide evidence to help identify cancer prevention targets during routine diabetes care.

Collaborative design of a health research training programme for nurses and midwives in Tshwane district, South Africa: a study protocol

Por: Gundo · R. · Mulaudzi · M. F.
Introduction

Nurses are essential for implementing evidence-based practices to improve patient outcomes. Unfortunately, nurses lack knowledge about research and do not always understand research terminology. This study aims to develop an in-service training programme for health research for nurses and midwives in the Tshwane district of South Africa.

Methods and analysis

This protocol outlines a codesign study guided by the five stages of design thinking proposed by the Hasso-Plattner Institute of Design at Stanford University. The participants will include nurses and midwives at two hospitals in the Tshwane district, Gauteng Province. The five stages will be implemented in three phases: Phase 1: Stage 1—empathise and Stage 2—define. Exploratory sequential mixed methods including focus group discussions with nurses and midwives (n=40), face-to-face interviews (n=6), and surveys (n=330), will be used in this phase. Phase 2: Stage 3—ideate and Stage 4—prototype. A team of research experts (n=5), nurses and midwives (n=20) will develop the training programme based on the identified learning needs. Phase 3: Stage 5—test. The programme will be delivered to clinical nurses and midwives (n=41). The training programme will be evaluated through pretraining and post-training surveys and face-to-face interviews (n=4) following training. SPSS V.29 will be used for quantitative analysis, and content analysis will be used to analyse qualitative data.

Ethics and dissemination

The protocol was approved by the Faculty of Health Sciences Research Ethics Committee of the University of Pretoria (reference number 123/2023). The protocol is also registered with the National Health Research Database in South Africa (reference number GP_202305_032). The study findings will be disseminated through conference presentations and publications in peer-reviewed journals.

Quality measures of virtual care in ambulatory healthcare environments: a scoping review

Por: Petrie · S. · Laur · C. · Rios · P. · Suarez · A. · Makanjuola · O. · Burke · E. · Bhattacharyya · O. · Mukerji · G.
Objectives

Delivery of virtual care increased throughout the COVID-19 pandemic and persisted after physical distancing measures ended. However, little is known about how to measure the quality of virtual care, as current measures focus on in-person care and may not apply to a virtual context. This scoping review aims to understand the connections between virtual care modalities used with ambulatory patient populations and quality measures across the Quintuple Aim (provider experience, patient experience, per capita cost, population health and health equity).

Design

Virtual care was considered any interaction between patients and/or their circle of care occurring remotely using any form of information technology. Five databases (MEDLINE, Embase, PsycInfo, Cochrane Library, JBI) and grey literature sources (11 websites, 3 search engines) were searched from 2015 to June 2021 and again in August 2022 for publications that analysed virtual care in ambulatory settings. Indicators were extracted, double-coded into the Quintuple Aim framework; patient and provider experience indicators were further categorised based on the National Academy of Medicine quality framework (safety, effectiveness, patient-centredness, timeliness, efficiency and equity). Sustainability was added to capture the potential for continued use of virtual care.

Results

13 504 citations were double-screened resulting in 631 full-text articles, 66 of which were included. Common modalities included video or audio visits (n=43), remote monitoring (n=11) and mobile applications (n=11). The most common quality indicators were related to patient experience (n=58 articles), followed by provider experience (n=25 articles), population health outcomes (n=23 articles) and health system costs (n=19 articles).

Conclusions

The connections between virtual care modalities and quality domains identified here can inform clinicians, administrators and other decision-makers how to monitor the quality of virtual care and provide insights into gaps in current quality measures. The next steps include the development of a balanced scorecard of virtual care quality indicators for ambulatory settings to inform quality improvement.

Evidence for clinician underprescription of and patient non-adherence to guideline-recommended cardiovascular medications among adults with peripheral artery disease: protocol for a systematic review and meta-analysis

Por: de Launay · D. · Paquet · M. · Kirkham · A. M. · Graham · I. D. · Fergusson · D. A. · Nagpal · S. K. · Shorr · R. · Grimshaw · J. M. · Roberts · D. J.
Introduction

International guidelines recommend that adults with peripheral artery disease (PAD) be prescribed antiplatelet, statin and antihypertensive medications. However, it is unclear how often people with PAD are underprescribed these drugs, which characteristics predict clinician underprescription of and patient non-adherence to guideline-recommended cardiovascular medications, and whether underprescription and non-adherence are associated with adverse health and health system outcomes.

Methods and analysis

We will search MEDLINE, EMBASE and Evidence-Based Medicine Reviews from 2006 onwards. Two investigators will independently review abstracts and full-text studies. We will include studies that enrolled adults and reported the incidence and/or prevalence of clinician underprescription of or patient non-adherence to guideline-recommended cardiovascular medications among people with PAD; adjusted risk factors for underprescription of/non-adherence to these medications; and adjusted associations between underprescription/non-adherence to these medications and outcomes. Outcomes will include mortality, major adverse cardiac and limb events (including revascularisation procedures and amputations), other reported morbidities, healthcare resource use and costs. Two investigators will independently extract data and evaluate study risk of bias. We will calculate summary estimates of the incidence and prevalence of clinician underprescription/patient non-adherence across studies. We will also conduct subgroup meta-analyses and meta-regression to determine if estimates vary by country, characteristics of the patients and treating clinicians, population-based versus non-population-based design, and study risks of bias. Finally, we will calculate pooled adjusted risk factors for underprescription/non-adherence and adjusted associations between underprescription/non-adherence and outcomes. We will use Grading of Recommendations, Assessment, Development and Evaluation to determine estimate certainty.

Ethics and dissemination

Ethics approval is not required as we are studying published data. This systematic review will synthesise existing evidence regarding clinician underprescription of and patient non-adherence to guideline-recommended cardiovascular medications in adults with PAD. Results will be used to identify evidence-care gaps and inform where interventions may be required to improve clinician prescribing and patient adherence to prescribed medications.

PROSPERO registration number

CRD42022362801.

Using the Power Wheel as a transformative tool to promote equity through spaces and places of patient engagement

Por: Sayani · A. · Cordeaux · E. · Wu · K. · Awil · F. · Garcia · V. · Hinds · R. · Jeji · T. · Khan · O. · Soh · B.-L. · Mensah · D. · Monteith · L. · Musawi · M. · Rathbone · M. · Robinson · J. · Sterling · S. · Wardak · D. · Amsdr · I. · Khawari · M. · Niwe · S. · Hussain · A. · Forster · V. · May
Background

Patient engagement is the active collaboration between patient partners and health system partners towards a goal of making decisions that centre patient needs—thus improving experiences of care, and overall effectiveness of health services in alignment with the Quintuple Aim. An important but challenging aspect of patient engagement is including diverse perspectives particularly those experiencing health inequities. When such populations are excluded from decision-making in health policy, practice and research, we risk creating a healthcare ecosystem that reinforces structural marginalisation and perpetuates health inequities.

Approach

Despite the growing body of literature on knowledge coproduction, few have addressed the role of power relations in patient engagement and offered actionable steps for engaging diverse patients in an inclusive way with a goal of improving health equity. To fill this knowledge gap, we draw on theoretical concepts of power, our own experience codesigning a novel model of patient engagement that is equity promoting, Equity Mobilizing Partnerships in Community, and extensive experience as patient partners engaged across the healthcare ecosystem. We introduce readers to a new conceptual tool, the Power Wheel, that can be used to analyse the interspersion of power in the places and spaces of patient engagement.

Conclusion

As a tool for ongoing praxis (reflection +action), the Power Wheel can be used to report, reflect and resolve power asymmetries in patient-partnered projects, thereby increasing transparency and illuminating opportunities for equitable transformation and social inclusion so that health services can meet the needs and priorities of all people.

Online survey exploring researcher experiences of research funding processes in the UK: the effort and burden of applying for funding and fulfilling reporting requirements

Por: Fackrell · K. · Church · H. · Crane · K. · Recio-Saucedo · A. · Blatch-Jones · A. · Meadmore · K.
Objective

To explore researchers’ experiences of funding processes, the effort and burden involved in applying for funding, obtaining funding and/or fulfilling reporting requirements with a UK health and social care research funder.

Design/Setting

A cross-sectional online survey study with open (free-text) and closed questions (August to November 2021).

Participants

Researchers with experience of applying for/obtaining funding and/or experience of fulfilling reporting requirements for UK health and social care research funded between January 2018 and June 2021.

Results

The survey was completed by 182 researchers, of which 176 had experience with applying for/obtaining funding, and 143 had experience with fulfilling reporting requirements during the timeframe. The majority of the 176 respondents (58%) completed between 7 and 13 key processes in order to submit an application and 69% felt that it was critically important to undertake these key processes. Respondents (n=143) reported submitting an average of 17 reports as part of research monitoring to a range of organisations (eg, funders, Higher Education Institutions). However, only 33% of respondents felt it was critically important to provide the requested reporting information to the different organisations. Thematic analysis of free-text questions on application and reporting identified themes relating to process inefficiencies including streamlining and alignment of systems, lack of understanding of processes including a need for improved communication and feedback from organisations with clear explanations about what information is needed, when and why, the support required by respondents and the time, effort and impact on workload and well-being.

Conclusions

Through this study, we were able to identify funding processes that are considered by some to be effortful, but necessary, as well as those that were perceived as unnecessary, complex and repetitive, and may waste some researchers time and effort and impact on well-being. Possible solutions to increase efficiency and enhance value in these processes were identified.

Health-related quality of life after 12 months post discharge in patients hospitalised with COVID-19-related severe acute respiratory infection (SARI): a prospective analysis of SF-36 data and correlation with retrospective admission data on age, disease

Por: Wright · G. · Senthil · K. · Zadeh-Kochek · A. · Au · J. H.-s. · Zhang · J. · Huang · J. · Saripalli · R. · Khan · M. · Ghauri · O. · Kim · S. · Mohammed · Z. · Alves · C. · Koduri · G.

Long-term outcome and ‘health-related quality of life’ (HRQoL) following hospitalisation for COVID-19-related severe acute respiratory infection (SARI) is limited.

Objective

To assess the impact of HRQoL in patients hospitalised with COVID-19-related SARI at 1 year post discharge, focusing on the potential impact of age, frailty, and disease severity.

Method

Routinely collected outcome data on 1207 patients admitted with confirmed COVID-19 related SARI across all three secondary care sites in our NHS trust over 3 months were assessed in this retrospective cohort study. Of those surviving 1 year, we prospectively collected 36-item short form (SF-36) HRQoL questionnaires, comparing three age groups (

Results

Overall mortality was 46.5% in admitted patients. In our SF-36 cohort (n=169), there was a significant reduction in all HRQoL domains versus normative data; the most significant reductions were in the physical component (pemotional component (physical well-being versus CFS (the correlation coefficient=–0.37, p

Conclusion

There was a significant reduction in all SF-36 domains at 1 year. Poor CFS at admission was associated with a significant and prolonged impact on physical parameters at 1 year. Age had little impact on the severity of HRQoL, except in the domains of physical functioning and the overall physical component.

Temporal trends of ambulance time intervals for suspected stroke/transient ischaemic attack (TIA) before and during the COVID-19 pandemic in Ireland: a quasi-experimental study

Por: Burton · E. · Quinn · R. · Crosbie-Staunton · K. · Deasy · C. · Masterson · S. · O'Donnell · C. · Merwick · A. · Willis · D. · Kearney · P. M. · Mc Carthy · V. J. C. · Buckley · C. M.
Objectives

Time is a fundamental component of acute stroke and transient ischaemic attack (TIA) care, thus minimising prehospital delays is a crucial part of the stroke chain of survival. COVID-19 restrictions were introduced in Ireland in response to the pandemic, which resulted in major societal changes. However, current research on the effects of the COVID-19 pandemic on prehospital care for stroke/TIA is limited to early COVID-19 waves. Thus, we aimed to investigate the effect of the COVID-19 pandemic on ambulance time intervals and suspected stroke/TIA call volume for adults with suspected stroke and TIA in Ireland, from 2018 to 2021.

Design

We conducted a secondary data analysis with a quasi-experimental design.

Setting

We used data from the National Ambulance Service in Ireland. We defined the COVID-19 period as ‘1 March 2020–31 December 2021’ and the pre-COVID-19 period ‘1 January 2018–29 February 2020’.

Primary and secondary outcome measures

We compared five ambulance time intervals: ‘allocation performance’, ‘mobilisation performance’, ‘response time’, ‘on scene time’ and ‘conveyance time’ between the two periods using descriptive and regression analyses. We also compared call volume for suspected stroke/TIA between the pre-COVID-19 and COVID-19 periods using interrupted time series analysis.

Participants

We included all suspected stroke/TIA cases ≥18 years who called the National Ambulance Service from 2018 to 2021.

Results

40 004 cases were included: 19 826 in the pre-COVID-19 period and 19 731 in the COVID-19 period. All ambulance time intervals increased during the pandemic period compared with pre-COVID-19 (p

Conclusions

A ’shock' like a pandemic has a negative impact on the prehospital phase of care for time-sensitive conditions like stroke/TIA. System evaluation and public awareness campaigns are required to ensure maintenance of prehospital stroke pathways amidst future healthcare crises. Thus, this research is relevant to routine and extraordinary prehospital service planning.

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