Evidence-informed, experience-based co-design: a novel framework integrating research evidence and lived experience in priority-setting and co-design of health services

Objective
To describe a new co-design framework termed Evidence-informed, Experience-based Co-design (E2CD).

Background
Involving consumers and clinicians in planning, designing and implementing services results in the end-product being more likely to meet the needs of end-users and increases the likelihood of their uptake and sustainability. Different forms and definitions of co-design have been described in the literature and have had varying levels of success in health service redesign. However, many fall short of including people with lived experience in all aspects of the process, particularly in setting priorities for service (re)design. In addition, health services need to deliver evidence-based care as well as care that meets the needs of users, yet few ways of integrating research evidence into co-design processes are described. This paper describes a new framework to approach co-design which addresses these issues. We believe that it offers a roadmap to address some of healthcare’s most wicked problems and potentially improve outcomes for some of the most vulnerable people in our society. We use improving services for people with high healthcare service utilisation as a working example of the Framework’s application.

Conclusion
Evidence-informed experience-based co-design has the potential to be used as a framework for co-design that integrates research evidence with lived experience and provides people with lived experience a central role in decision-making about prioritising and designing services to meet their needs.

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Agosto 2024

Protocol for the process evaluation of the GOAL trial: investigating how comprehensive geriatric assessment (CGA) improves patient-centred goal attainment in older adults with chronic kidney disease in the outpatient setting

Introduction
The GOAL Cluster Randomised Controlled Trial (NCT04538157) is now underway, investigating the impact of comprehensive geriatric assessment (CGA) for frail older people with chronic kidney disease (CKD). The primary outcome is the attainment of patient-identified goals at 3 months, assessed using the goal attainment scaling process. The protocol requires a dedicated process evaluation that will occur alongside the main trial, to investigate issues of implementation, mechanisms of impact and contextual factors that may influence intervention success. This process evaluation will offer novel insights into how and why CGA might be beneficial for frail older adults with CKD and provide guidance when considering how to implement this complex intervention into clinical practice.

Methods and analysis
This process evaluation protocol follows guidance from the Medical Research Council and published guidance specific for the evaluation of cluster-randomised trials. A mixed methodological approach will be taken using data collected as part of the main trial and data collected specifically for the process evaluation. Recruitment and process data will include site feasibility surveys, screening logs and site issues registers from all sites, and minutes of meetings with intervention and control sites. Redacted CGA letters will be analysed both descriptively and qualitatively. Approximately 60 semistructured interviews will be analysed with a qualitative approach using a reflexive thematic analysis, with both inductive and deductive approaches underpinned by an interpretivist perspective. Qualitative analyses will be reported according to the Consolidated criteria for Reporting Qualitative research guidelines. The Standards for Quality Improvement Reporting Excellence guidelines will also be followed.

Ethics and dissemination
Ethics approval has been granted through Metro South Human Research Ethics Committee (HREC/2020/QMS/62883). Dissemination will occur through peer-reviewed journals and feedback to trial participants will be facilitated through the central coordinating centre.

Trial registration number
NCT04538157.

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Agosto 2024

Use of pressure muscle index to guide pressure support ventilation setting: a study protocol and statistical plan for a prospective randomised controlled proof-of-concept trial

Introduction
Although pressure support ventilation is one of the most commonly used assisted ventilation modes in intensive care units, there is still a lack of precise strategies for setting pressure support. By performing an end-inspiratory airway occlusion, the difference between the peak and plateau airway pressure, which is defined as pressure muscle index (PMI), can be easily measured on the ventilator screen. Previous studies have shown that PMI is accurate in detecting high and low inspiratory effort. No study has been conducted to investigate the use of PMI as an indicator for setting inspiratory pressure support.

Method and analysis
This is a study protocol for a prospective, single-centre, randomised controlled, pilot trial. Sixty participants undergoing pressure support ventilation will be randomly assigned in a 1:1 ratio to the control group or intervention group, with pressure support adjusted according to standard care or guided by the PMI strategy for 48 hours, respectively. The feasibility of the PMI-guided strategy will be evaluated. The primary endpoint is the proportion of inspiratory effort measurements within a well-accepted ‘normal’ range, which is predefined as oesophageal pressure–time product per minute between 50 and 200 cmH2O⋅s/min, for each patient during 48 hours of pressure support adjustment.

Ethics and dissemination
The study protocol has been approved by Beijing Tiantan Hospital (KY2023-005-02). The data generated in the present study will be available from the corresponding author on reasonable request. The results of the trial will be submitted to international peer-reviewed journals.

Trial registration number
NCT05963737; ClinicalTrials.org.

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Agosto 2024

Physicians knowledge and attitudes towards telesurgery and its associated factors in a resource-limited setting, Northwest Ethiopia, 2022: a cross-sectional study design

Background
Telesurgery has become helpful in overcoming the current shortage of surgeons and reducing the barriers to timely and effective surgical intervention caused by long-distance travel, which is caused by distance, cost, complexity and frequent hazards. However, knowledge and attitude remain challenges in the implementation of such a system.

Objective
This study aimed to assess physicians’ knowledge and attitude towards telesurgery and associated factors at resource-limited setting, Northwest Ethiopia.

Method and analysis
A simple random sampling method was carried out to choose study participants from each referral hospital, and data were collected using self-administered questionnaires. Descriptive and inferential statistics were applied to estimate knowledge and attitudes towards telesurgery among physicians and to identify factors associated with physician knowledge and attitudes towards telesurgery.

Study design
Cross-sectional study design.

Setting
This study was conducted at six specialised referral hospitals and two specialised and teaching referral hospitals in the Amhara region, northwest Ethiopia.

Result
408 physicians were included for analysis, with a response rate of 96.45%. Among study participants, 47.8% and 43.1% had good knowledge and attitudes towards telesurgery, respectively. Educational status, digital literacy, source of information, computer training, digital health training and internet access in the organisation were factors associated with a physician’s knowledge of telesurgery. Moreover, physician’s knowledge, technology use, educational status, computer training, computer access and internet access in the organisation were factors associated with physicians’ attitudes towards telesurgery.

Conclusion and recommendation
Almost half of physicians had good knowledge, and less than half had a good attitude towards telesurgery, so healthcare policy-makers should improve physicians’ digital literacy, technology use and internet access to enhance their knowledge and attitudes for future implementation.

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Luglio 2024

Respiratory support with standard low-flow oxygen therapy, high-flow oxygen therapy or continuous positive airway pressure in adults with acute hypoxaemic respiratory failure in a resource-limited setting: protocol for a randomised, open-label, clinical trial – the Acute Respiratory Intervention StudiEs in Africa (ARISE-AFRICA) study

Rationale
Acute hypoxaemic respiratory failure (AHRF) is associated with high mortality in sub-Saharan Africa. This is at least in part due to critical care-related resource constraints including limited access to invasive mechanical ventilation and/or highly skilled acute care workers. Continuous positive airway pressure (CPAP) and high-flow oxygen by nasal cannula (HFNC) may prove useful to reduce intubation, and therefore, improve survival outcomes among critically ill patients, particularly in resource-limited settings, but data in such settings are lacking. The aim of this study is to determine whether CPAP or HFNC as compared with standard oxygen therapy, could reduce mortality among adults presenting with AHRF in a resource-limited setting.

Methods
This is a prospective, multicentre, randomised, controlled, stepped wedge trial, in which patients presenting with AHRF in Uganda will be randomly assigned to standard oxygen therapy delivered through a face mask, HFNC oxygen or CPAP. The primary outcome is all-cause mortality at 28 days. Secondary outcomes include the number of patients with criteria for intubation at day 7, the number of patients intubated at day 28, ventilator-free days at day 28 and tolerance of each respiratory support.

Ethics and dissemination
The study has obtained ethical approval from the Research and Ethics Committee, School of Biomedical Sciences, College of Health Sciences, Makerere University as well as the Uganda National Council for Science and Technology. Patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.

Trial registration number
NCT04693403.

Protocol version
8 September 2023; version 5.

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Luglio 2024