Implementation salvage experiences from the Melbourne diabetes prevention study

Background Many public health interventions based on apparently sound evidence from randomised controlled trials encounter difficulties when being scaled up within health systems. Even under the best of circumstances, implementation is exceedingly difficult. In this paper we will describe the implementation salvage experiences from the Melbourne Diabetes Prevention Study, which is a randomised controlled trial of the effectiveness and cost-effectiveness nested in the state-wide Life! Taking Action on Diabetes program in Victoria, Australia.Discussion The Melbourne Diabetes Prevention Study sits within an evolving larger scale implementation project, the Life! program. Changes that occurred during the roll-out of that program had a direct impact on the process of conducting this trial. The issues and methods of recovery the study team encountered were conceptualised using an implementation salvage strategies framework. The specific issues the study team came across included continuity of the state funding for Life! program and structural changes to the Life! program which consisted of adjustments to eligibility criteria, referral processes, structure and content, as well as alternative program delivery for different population groups. Staff turnover, recruitment problems, setting and venue concerns, availability of potential participants and participant characteristics were also identified as evaluation roadblocks. Each issue and corresponding salvage strategy is presented.Summary The experiences of conducting such a novel trial as the preliminary Melbourne Diabetes Prevention Study have been invaluable. The lessons learnt and knowledge gained will inform the future execution of this trial in the coming years. We anticipate that these results will also be beneficial to other researchers conducting similar trials in the public health field. We recommend that researchers openly share their experiences, barriers and challenges when conducting randomised controlled trials and implementation research. We encourage them to describe the factors that may have inhibited or enhanced the desired outcomes so that the academic community can learn and expand the research foundation of implementation salvage.<br /

Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570

Diabetes in Appalachia: Providers\u27 perspectives

© 2020 The Author(s). Background: Southeastern Appalachian Ohio has more than double the national average of diabetes and a critical shortage of healthcare providers. Paradoxically, there is limited research focused on primary care providers\u27 experiences treating people with diabetes in this region. This study explored providers\u27 perceived barriers to and facilitators for treating patients with diabetes in southeastern Appalachian Ohio.Methods: We conducted in-depth interviews with healthcare providers who treat people with diabetes in rural southeastern Ohio. Interviews were transcribed, coded, and analyzed via content and thematic analyses using NVivo 12 software (QSR International, Chadstone, VIC, Australia).Results: Qualitative analysis revealed four themes: (1) patients\u27 diabetes fatalism and helplessness: Providers recounted story after story of patients believing that their diabetes was inevitable and that they were helpless to prevent or delay diabetes complications. (2) Comorbid psychosocial issues: Providers described high rates of depression, anxiety, incest, abuse, and post-traumatic stress disorder among people with diabetes in this region. (3) Inter-connected social determinants interfering with diabetes care: Providers identified major barriers including lack of access to providers, lack of access to transportation, food insecurity, housing insecurity, and financial insecurity. (4) Providers\u27 cultural understanding and recommendations: Providers emphasized the importance of understanding of the values central to Appalachian culture and gave culturally attuned clinical suggestions for how to use these values when working with this population.Conclusions: Evidence-based interventions tailored to Appalachian culture and training designed to increase the cultural competency and cultural humility of primary care providers may be effective approaches to reduce barriers to diabetes care in Appalachian Ohio

“Renewed” “older” motherhood/mothering: a qualitative exploration

This is the author accepted manuscript. The final version is available from the publisher via the DOI in this record.This UK-based qualitative study explored multiparous women’s experiences of being “older” mothers. Respondents were “renewed mothers” who had a child/children relatively early in their reproductive careers and then again after 35 years of age. Key themes arising from the empirical data were: instrumental role of male partners in post-35 mothering, purported “renewal” of self in the face of menopause/diminution of mothering, caring for teenagers and babies/toddlers simultaneously, and subjection to criticisms of “wrong-aged” motherhood. Experiences of “renewed” “older” mothers suggest significant hard work is necessitated both in terms of mothering and presentation of self as an appropriate mother