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AnteayerBMJ Open

Building CapaCITY/E for sustainable transportation: protocol for an implementation science research program in healthy cities

Por: Winters · M. · Fuller · D. · Cloutier · M.-S. · Harris · M. A. · Howard · A. · Kestens · Y. · Kirk · S. · Macpherson · A. · Moore · S. · Rothman · L. · Shareck · M. · Tomasone · J. R. · Laberee · K. · Stephens · Z. P. · Sones · M. · Ayton · D. · Batomen · B. · Bell · S. · Collins · P. · Diab
Introduction

Improving sustainable transportation options will help cities tackle growing challenges related to population health, congestion, climate change and inequity. Interventions supporting active transportation face many practical and political hurdles. Implementation science aims to understand how interventions or policies arise, how they can be translated to new contexts or scales and who benefits. Sustainable transportation interventions are complex, and existing implementation science frameworks may not be suitable. To apply and adapt implementation science for healthy cities, we have launched our mixed-methods research programme, CapaCITY/É. We aim to understand how, why and for whom sustainable transportation interventions are successful and when they are not.

Methods and analysis

Across nine Canadian municipalities and the State of Victoria (Australia), our research will focus on two types of sustainable transportation interventions: all ages and abilities bicycle networks and motor vehicle speed management interventions. We will (1) document the implementation process and outcomes of both types of sustainable transportation interventions; (2) examine equity, health and mobility impacts of these interventions; (3) advance implementation science by developing a novel sustainable transportation implementation science framework and (4) develop tools for scaling up and scaling out sustainable transportation interventions. Training activities will develop interdisciplinary scholars and practitioners able to work at the nexus of academia and sustainable cities.

Ethics and dissemination

This study received approval from the Simon Fraser University Office of Ethics Research (H22-03469). A Knowledge Mobilization Hub will coordinate dissemination of findings via a website; presentations to academic, community organisations and practitioner audiences; and through peer-reviewed articles.

Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives

Por: Chatters · R. · Dimairo · M. · Cooper · C. · Ditta · S. · Woodward · J. · Biggs · K. · Ogunleye · D. · Thistlethwaite · F. · Yap · C. · Rothman · A.
Objectives

To explore the importance of, and barriers to achieving, diversity in early-phase clinical trials.

Design

Qualitative interviews analysed using thematic analysis.

Setting and participants

Five professionals (clinical researchers and methodologists) and three patient and public representatives (those with experience of early-phase clinical trials and/or those from ethnic minority backgrounds) were interviewed between June and August 2022. Participants were identified via their institutional web page, existing contacts or social media (eg, X, formerly known as Twitter).

Results

Professionals viewed that diversity is not currently considered in all early-phase clinical trials but felt that it should always be taken into account. Such trials are primarily undertaken at a small number of centres, thus limiting the populations they can access. Referrals from clinicians based in the community may increase diversity; however, those referred are often not from underserved groups. Referrals may be hindered by the extra resources required to approach and recruit underserved groups and participants often having to undertake ‘self-driven’ referrals. Patient and public representatives stated that diversity is important in research staff and that potential participants should be informed of the need for diversity. Those from underserved groups may require clarification regarding the potential harms of a treatment, even if these are unknown. Education may improve awareness and perception of early-phase clinical trials. We provide 14 recommendations to improve diversity in early-phase clinical trials.

Conclusions

Diversity should be considered in all early-phase trials. Consideration is required regarding the extent of diversity and how it is addressed. The increased resources needed to recruit those from underserved groups may warrant funders to increase the funds to support the recruitment of such participants. The potential harms and societal benefits of the research should be presented to potential participants in a balanced but accurate way to increase transparency.

Risk assessment and real-world outcomes in chronic thromboembolic pulmonary hypertension: insights from a UK pulmonary hypertension referral service

Por: Kiely · D. G. · Hamilton · N. · Wood · S. · Durrington · C. · Exposto · F. · Muzwidzwa · R. · Raiteri · L. · Beaudet · A. · Muller · A. · Sauter · R. · Pillai · N. · Lawrie · A. · ASPIRE consortium · Condliffe · Elliot · Hameed · Charalampopoulos · Rothman · Roger Thompson · Hurdman
Objectives

This study was conducted to evaluate the ability of risk assessment to predict healthcare resource utilisation (HCRU), costs, treatments, health-related quality of life (HRQoL) and survival in patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH).

Design

Retrospective observational study.

Setting

Pulmonary hypertension referral centre in the UK.

Participants

Adults diagnosed with CTEPH between 1 January 2012 and 30 June 2019 were included. Cohorts were retrospectively defined for operated patients (received pulmonary endarterectomy (PEA)) and not operated; further subgroups were defined based on risk score (low, intermediate or high risk for 1-year mortality) at diagnosis.

Primary and secondary outcome measures

Demographics, clinical characteristics, comorbidities, treatment patterns, HRQoL, HCRU, costs and survival outcomes were analysed.

Results

Overall, 683 patients were analysed (268 (39%) operated; 415 (61%) not operated). Most patients in the operated and not-operated cohorts were intermediate risk (63%; 53%) or high risk (23%; 31%) at diagnosis. Intermediate-risk and high-risk patients had higher HCRU and costs than low-risk patients. Outpatient and accident and emergency visits were lower postdiagnosis for both cohorts and all risk groups versus prediagnosis. HRQoL scores noticeably improved in the operated cohort post-PEA, and less so in the not-operated cohort at 6–18 months postdiagnosis. Survival at 5 years was 83% (operated) and 49% (not operated) and was lower for intermediate-risk and high-risk patients compared with low-risk patients.

Conclusions

Findings from this study support that risk assessment at diagnosis is prognostic for mortality in patients with CTEPH. Low-risk patients have better survival and HRQoL and lower HCRU and costs compared with intermediate-risk and high-risk patients.

Can online and app-based interventions be used by people with diabetes to reduce diabetes distress? A protocol for a scoping review

Por: Andersen · C. M. · Mathiesen · A. S. · Pouwer · F. · Mouritsen · J. D. · Mathiasen · K. · Rothmann · M. J.
Introduction

Diabetes distress has been defined as "the negative emotional or affective experience resulting from the challenge of living with the demands of diabetes". Diabetes distress affects 20%–25% of individuals living with diabetes and can have negative effects on both diabetes regulation and quality of life. For people living with diabetes distress, innovative tools/interventions such as online or app-based interventions may potentially alleviate diabetes distress in a cost-effective way. The specific research questions of this scoping review are: (1) what are the effects of online or app-based interventions on diabetes distress for adults with type 1 or type 2 diabetes, and (2) what are the characteristics of these interventions (eg, type of intervention, duration, frequency, mode of delivery, underlying theories and working mechanisms)?

Methods and analysis

A scoping review will be conducted, using the methodological framework of Arksey and O’Malley along with Levac et al. Eligible studies are: studies of adults ≥18 years old with type 1 or 2 diabetes using an online or app-based intervention and assessing diabetes distress as the primary or secondary outcome. Five databases (Medline, EMBASE, CINAHL, PsycINFO and Scopus) will be searched and is limited to articles written in English, Danish, Norwegian, Swedish or Dutch. Two reviewers will independently screen potentially eligible studies in Covidence, select studies, and together chart data, collate, summarise, and report the results. We will adhere to the Preferred reporting Items for Systematic Reviews and Meta-Analysis for Scoping Reviews (PRISMA-ScR).

Ethics and dissemination

The scoping review has been exempt from full ethical review by the Regional Committees on Health Research Ethics for Southern Denmark (case number: S-20232000-88). The results of the review will be published in a peer-reviewed journal and presented at relevant conferences and workshops with relevant stakeholders.

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