Protocol of digital decision support system (DDSS) embedded within a tele-primary healthcare platform in Pakistan: an assessment of usability, acceptability, effectiveness and perceived quality of care in a resource-constrained setting

Background
A digital decision support system in healthcare is a digital health intervention that assists healthcare professionals in decision-making by providing treatment recommendations and enhancing diagnostic accuracy and quality of care. This will be the first study in Pakistan to assess the system’s usability, acceptability and effectiveness in improving healthcare outcomes while also evaluating the perceived quality of care. This comprehensive assessment will inform policy development in areas such as the scale-up of digital health interventions, data privacy and technology interoperability. Measures of effectiveness will include changes in clinical outcomes through a patient exit feedback survey. This study aims to evaluate the role of digital decision support systems in healthcare decision-making, which may be integrated into Pakistan’s tele-primary healthcare system.

Methods
The study will employ a multimethod approach. The data collection tools are adapted from the WHO’s digital health intervention monitoring and evaluation framework and include a technology assessment, healthcare provider surveys, patient exit interviews and focus group discussions with healthcare providers. Purposive sampling will be used for qualitative interviews with providers (doctors) and patients. Government stakeholders, private sectors, multilateral, academia and policymakers will be engaged through a consultative meeting. We will also conduct a literature review, as well as a comprehensive analysis of existing studies, documents and data relevant to digital decision support systems and digital health interventions implemented globally, and assess the performance, challenges and opportunities.

Ethics and dissemination
The study has been approved by the Ethics Review Committee at The Aga Khan University (2023-8514-26533). The dissemination of study findings through scientific publications and seminars will enable programme managers and policymakers to design tools to improve the quality of care provided through telemedicine platforms. This will contribute to efficient decision-making, access and quality of care for primary healthcare in low-income and middle-income countries. This study will also inform policy regarding the scale-up of decision support systems in primary care settings, data privacy and technology interoperability.

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Settembre 2024

Association of socioeconomic status with prognosis in hypertensive patients over age 65: a cohort study in the community setting

Objective
To examine whether socioeconomic status is associated with prognosis after the diagnosis of hypertension (HTN), in a population older than 65 years, in the community setting.

Design
Retrospective cohort study.

Setting
All the primary care centres of the Community of Madrid (n=392).

Participants
All patients ( >65 years) with a new diagnosis of HTN in 2007–08, without previous kidney or cardiovascular (K/CV) events (n=21 754).
Patient records from primary care electronic health records and Spanish mortality database were analysed from January 2007 through December 2018. Sociodemographic data such as age, gender, Area Deprivation Index (MEDEA—Mortalidad en áreas pequeñas Españolas y Desigualdades Socioeconómicas y Ambientales—Index in quintiles), and characteristics, such as smoking, type 2 diabetes mellitus and hypercholesterolaemia, were collected at the time of enrolment.

Primary and secondary outcome measures
The occurrence of K/CV events (including mortality from these causes) and total mortality were evaluated using Cox regression.

Results
Patients had a mean age of 73.5 (SD 6.5) years, and 63.5% were women. The median follow-up was 128.7 months (IQR: 110.6–136.7 months). There were 10 648 first K/CV events, including 1508 deaths from these causes and 4273 deaths from other causes. Adjusted for age, gender, smoking, diabetes and hypercholesterolaemia, when comparing the third, fourth and last quintiles (less affluent) of the Deprivation Index with respect to the first quintile, the hazard of K/CV events increased by 14.8% (95% CI: 3.3 to 27.6%), 16.0% (95% CI: 6.4 to 26.4%) and 19.1% (95% CI: 8.9 to 30.2%), respectively. The MEDEA Index was not associated with differences in adjusted total mortality.

Conclusion
Living in a low socioeconomic status area is associated with an increase in kidney or cardiovascular events in hypertensive patients diagnosed after age 65 years, which will result in a significant increase in disease burden even if not related to an increase in total mortality.

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Agosto 2024

Addressing mental illness stigma in German higher education: study protocol for a mixed-methods evaluation of a psychosocial setting-based intervention

Introduction
Mental illness stigma is associated with a range of negative consequences, such as reduced help-seeking for mental health problems. Since stigma affects individual, social, and structural aspects, multilevel interventions such as the Canadian programme The Working Mind have been proven to be the most effective. Given the solid evidence base for The Working Mind, it is our aim to implement and evaluate culturally adapted versions of the programme in German higher education, targeting students, employees and managers.

Methods and analysis
We will evaluate the programme with regard to its effect on mental illness stigma, openness to mental health problems, willingness to seek help, and positive mental health outcomes. Further, we will investigate the programme’s effectiveness dependent on gender and personal values, various mechanisms of change, and factors facilitating and hindering implementation. The study uses a sequential explanatory mixed-methods evaluation design (QUAN – > qual) that consists of three steps: (1) quasi-experimental online survey with programme participants, (2) focus groups with programme participants, and (3) qualitative interviews with programme stakeholders. The quantitative data collected in step 1 will be analysed using 2×3 analysis of variances and a parallel multiple mediation analysis. The results will inform the qualitative data to be collected in steps 2 and 3, which will be analysed using qualitative content analysis.

Ethics and dissemination
The study was approved by the local Ethics Committee (Ethics Committee of University Medicine Greifswald; BB 098/23). Participants have to provide written consent before taking part in a focus group or interview. As for the online survey, participants have to give their consent by agreeing to an online data protection form before they can start completing the survey. We will publish central results and the anonymised data in an Open Access Journal. Further, the statistical code will be included as a supplement to the paper(s) documenting the results of the study.

Trial registration number
DRKS00033523.

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Agosto 2024

Deprescribing benzodiazepine receptor agonists in older adults: a mixed-methods study to adapt the Canadian D-PRESCRIBE intervention to the Belgian community setting

Objective
Guidelines recommend deprescribing benzodiazepine receptor agonists (BZRA) in older adults, yet implementation in clinical practice remains limited. Adapting effective, evidence-based interventions to a new context is a resource-saving strategy. In Canada, the D-PRESCRIBE intervention comprised a patient educational brochure and a pharmaceutical opinion inviting physicians to revise BZRA prescribing and consider safer alternatives. Due to its effectiveness on BZRA deprescribing among Canadian older adults, we aimed to adapt the D-PRESCRIBE intervention to the Belgian community setting.

Design
Recommendations from the ADAPT guidance, that provides a systematic approach for adapting interventions to new contexts, were followed. We conducted a mixed-methods study that comprised (1) group discussions and cognitive interviews to assess the acceptability and need for adaptation of the intervention’s components and (2) a survey on the adapted pharmaceutical opinion. A research committee involving stakeholders’ representatives decided on the adaptations, respecting the core functions of both tools. Changes in intervention components were reported following the Model for Adaptation Design and Impact framework.

Setting
Belgian French-speaking community setting.

Participants
Six older adults (≥65 years), six general practitioners (GPs) and seven pharmacists participated in the group discussions or interviews. 46 GPs and 91 pharmacists responded to the survey.

Results
Participants welcomed the brochure positively. Still, some changes in the vocabulary, wording, photos and icons were made for several purposes including making the patient feel concerned about the brochure and softening the use of fear. The pharmaceutical opinion aroused mixed perceptions. Its name, layout and content were adapted to enhance its acceptability and fit with our healthcare system, practices and national guidelines. The survey highlighted several enablers and barriers to its use from the perspectives of GP and pharmacist.

Conclusions
The Canadian D-PRESCRIBE intervention was adapted to the Belgian setting following a thorough and transparent process. Its feasibility will be tested in a future pilot study (NCT:05929417).

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Agosto 2024

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