Assessing disease control in inflammatory bowel disease: a real world cross-sectional study in the UK (PODCAST-IBD).

OBJECTIVE: Proportion Of suboptimal Disease Control And Strategy of Treatment in IBD (PODCAST-IBD) was an international real-world study which aimed to quantify disease control in IBD using STRIDE-II recommendations. DESIGN/METHOD: Cross-sectional assessment of IBD patients attending routine clinic appointments in four UK centers October 2022 to January 2023. Clinician-reported outcomes, patient-reported outcomes and retrospective data from medical chart review were used to assess IBD control against red flags aligned to STRIDE-II. RESULTS: Data were available from 198 UK patients. IBD was suboptimally controlled in 52.4% (54/103) of patients with Crohn's disease (CD) and 45.3% (43/95) with ulcerative colitis (UC). Impaired quality of life (QOL), defined as Short inflammatory bowel disease questionnaire (SIBDQ) score <50, was the main contributor to suboptimal disease control. Suboptimal disease control has a detrimental impact on fatigue and disability with significantly lower mean Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score in suboptimally controlled disease (CD: 81.5 vs 125, UC: 87.4 vs 122.8) and IBD Disk. Suboptimal disease control results in higher health care resource use (HCRU) (CD: £4,746 vs £1,924; UC: £2,428 vs £1,121) and higher rates of work productivity loss (CD: 41.7% vs 11.9%, UC: 38.0% vs 22.6%). CONCLUSION: IBD was suboptimally controlled in around one-half of patients. Impaired QOL was the most common contributor (64%, 62/97) to suboptimal control. Suboptimal control had a considerable economic impact; HCRU more than doubled and productivity fell. Physicians could consider regular QOL assessments to prompt timely disease monitoring to enable identification of early active disease and appropriate treatment.

Inflammatory bowel disease (IBD), which encompasses Crohn's disease (CD) and ulcerative colitis (UC), is a life-long, painful and debilitating disease. Symptoms include abdominal pain, diarrhea and extreme tiredness (fatigue) and may also affect the eyes, joints and skin. People with IBD have periods of time where their symptoms are not controlled (known as relapse), with minimal symptoms (known as remission) at other times. This paper reports on people from the UK who participated in the wider international PODCAST-IBD study. The PODCAST-IBD study used information from people with IBD, their doctors and their medical notes to assess how well IBD was controlled and the impact of suboptimal disease control on their lives and use of healthcare. Overall, IBD was suboptimally controlled in around one-half of the people with IBD: 52.4% (54/103) of those with CD and 45.3% (43/95) with UC. Reduced quality of life (QOL) was the most common contributor to suboptimal control with almost two-thirds of people reporting impaired QOL. Suboptimal control of IBD impacts on people's everyday life ­ resulting in fatigue and disability, reducing QOL and making it difficult to work. Suboptimal control of IBD also has a considerable economic impact since it results in increased healthcare use. It might be helpful for doctors to consider regular QOL assessments to help to identify those people whose IBD is not well controlled to ensure that they receive appropriate treatment to control disease and improve their lives.

Approaches towards pragmatic language assessment in Indian pre-schoolers: A survey among speech-language pathologists.

Background: Pragmatic language assessment in children is performed in line with standard protocols, guidelines, and best practices. The absence of these aspects in the Indian context has resulted in the quest to explore the approaches used by speech-language pathologists (SLPs) to assess pragmatic language impairments. This survey explored the current practices of SLPs towards the assessment of pragmatic language among preschool children in India. It also aimed to identify the barriers, facilitators and identify the level of knowledge, skill and overall practice of SLPs towards their practices using self-appraisal. Methods: A total of 100 SLPs(94 females and 6 males) working with preschool aged children (three-to-six-year-olds) from across different Indian states participated in the survey. Participants were enquired about the aspects of pragmatic language assessed, methods used for assessment, awareness and use of Indian tools, the settings, members, and language used for the assessment. Additionally, they were asked to mention the specific tools used, informal methods used, barriers and facilitators, and self-appraise their knowledge, skill and overall practice. Results: Majority of participants assessed multiple aspects of pragmatic language. All used a combination of different assessment methods, with the participants commonly using informal compared to formal approaches. Preschoolers were assessed at multiple settings, along with different communication partners. Lack of awareness on assessment tools developed in India was the major barrier, while the use of informal tasks or activities were the major facilitators influencing pragmatic language assessment to a greater extent. The knowledge and skills for the assessment of pragmatic language obtained poorer scores compared to practices. Conclusions: The assessment practices of the SLPs were largely influenced by the unavailability of developed or adapted tools for Indian preschoolers, leading to the need to develop indigenous assessment tools. Certain considerations for further assessment practices have been identified and discussed.

Feasibility of Implementing Dementia Collaborative Coaching into Routine Care in Nursing Homes.

OBJECTIVES: The study evaluated the feasibility of implementing Dementia Collaborative Coaching (DCC) into the routine workflow of speech-language pathologists (SLPs) working in nursing homes (NHs). DCC is an intervention delivered by SLPs to train nursing assistants (CNAs) in communication strategies to support people living with dementia (PLWD). METHODS: We assessed the feasibility of identifying eligible PLWD; estimated intervention fidelity; evaluated suitability of outcome measures; and determined the preliminary impact on behavioral and psychological symptoms of distress (BPSD) among PLWD. SLPs completed a semi-structured interview to collect further acceptability data. RESULTS: Four SLPs in four NHs completed DCC with 10 CNAs and 15 eligible PLWD that they appropriately identified from their caseloads. SLPs conducted 90 DCC sessions with 64% fidelity and billed Medicare for all sessions. The outcome measure of Minimum Data Set item E0200B: Rejection of Care did not vary enough to be useful, but positive changes were noted on the Cohen-Mansfield Agitation Inventory, t(14) = 10.51, p < .001, Cohen's d = 2.76. Interviews further indicated feasibility. CONCLUSIONS: It is feasible to implement DCC into the workflow of SLPs in NHs. CLINICAL IMPLICATIONS: Given the feasibility and preliminary positive impacts, SLPs could consider implementing DCC in routine care.

Research on pragmatic impairment in autistic children during the past two decades (2001-2022): hot spots and frontiers-based on CiteSpace bibliometric analysis.

Pragmatic impairment has become a critical aspect of language development in autistic children and has gained significant academic attention over the past two decades. This study leverages bibliometric methods to conduct an exhaustive analysis of literature derived from Web of Science database. Utilizing CiteSpace software, we construct a knowledge map to dissect the academic hotspots in research related to pragmatic impairment in autistic children. This enables us to delineate the evolutionary trajectory of this research domain, analyze the prevailing research dimensions, and anticipate potential future dimensions. Our findings indicate that research hotspots in this field over the past two decades predominantly concentrate on assessing and diagnosing pragmatic impairment in autistic children, intervention strategies, and theory of mind. The research scope on pragmatic impairment in autistic children has progressively broadened and deepened. Research has evolved from initial descriptions and interpretations of autism to exploring the theory of mind in high-functioning, school-aged children. The current emphasis is on examining the specific skills that these children possess.

Time of day for vaccination, outcomes, and relative effectiveness of high-dose vs. standard-dose quadrivalent influenza vaccine: A post hoc analysis of the DANFLU-1 randomized clinical trial.

OBJECTIVES: Morning influenza vaccination enhances antibody response. In this post hoc analysis of the DANFLU-1 trial, we sought to evaluate the association between time of day for vaccination (ToV) and outcomes and whether ToV modified the relative effectiveness of high-dose (QIV-HD) vs. standard-dose (QIV-SD) quadrivalent influenza vaccine. METHODS: DANFLU-1 was a pragmatic feasibility trial of QIV-HD vs. QIV-SD. Outcomes included hospitalizations and mortality. For subgroup analysis, the population was dichotomized at median ToV into two groups (early and late). RESULTS: The study population included 12,477 participants. Mean age was 71.7 ± 3.9 years with 5877 (47.1%) female participants. Median ToV was 11.29 AM. Earlier ToV was associated with fewer respiratory hospitalizations independent of vaccine type, which persisted in adjusted analysis (IRR 0.88 per 1-hour decrement (95% CI 0.78- 0.98, p = 0.025). No effect modification by continuous or dichotomous ToV was found. In subgroup analysis, effects consistently favored QIV-HD against hospitalizations for pneumonia or influenza (early: IRR 0.30; late: 0.29), all-cause hospitalizations (early: IRR 0.87; late: 0.86), and mortality (early: HR 0.53; late: 0.50). CONCLUSION: In this exploratory post hoc analysis, earlier ToV was associated with fewer respiratory hospitalizations. The relative effectiveness of QIV-HD vs. QIV-SD was not modified by ToV. Further research is needed to confirm findings. TRIAL REGISTRATION: Clinicaltrials.gov: NCT05048589.

Towards multi-faceted outcomes of participation-based interventions: mapping the PREP's effects for children and youth with disabilities.

PURPOSE: Systematically organizing participation effects may guide participation-based research designs in rehabilitation. This perspective paper uses existing evidence on Pathways and Resources for Engagement and Participation (PREP) to showcase the multitude of effects from a single intervention and synthesize the magnitude of these effects. METHODS: An outcome matrix of participation effects comprising three dimensions (intermediate, instrumental, ultimate) and two levels (transient, enduring) was used to systematically map PREP's effects. Forest plot demonstrated clinically important changes in the Canadian Occupational Performance Measure (COPM) across studies. Effect sizes were calculated. RESULTS: The majority of outcomes from 11 studies were mapped to ultimate-transient effects (e.g., changes in participation of self-chosen activities), followed by instrumental-transient effects (e.g., changes in motor body functions). Fewer outcomes were mapped to ultimate-enduring effects (e.g., changes of participation for a longer period or across settings) or intermediate-enduring effects (e.g., therapist-applied knowledge), demonstrating the gaps for investigating enduring effects. COPM changes in most studies (89%) showed clinical significance with small to large effects. CONCLUSIONS: Systematic mapping from PREP example guides categorizing multidimensional outcomes. Future participation-based studies can employ individual-based mixed-methods designs to delve into the long-lasting enduring outcomes of youth capacity-building and the transformative process of pursuing meaningful participation goals.

Systematically organizing participation effects according to the proposed matrix enhances understanding of multidimentisonal outcomes from a single participation-based intervention.Child/youth-engaging interventions like Pathways and Resources for Engagement and Participation (PREP) can offer a multitude of benefits that promote outcomes of participation and physical and mental health, enhancing efficient/effective rehabilitation services.It is essential that future intervention designs prioritize long-lasting/enduring effects across broad settings and capture underlying processes and capacity building of children/youth toward sustainable participation outcomes.

Medical Assistance in Dying in Quebec: A Continuum Between Teams' Accountability and Interdisciplinary Support Groups' Assumption of Responsibility.

Objectives: In the province of Quebec, Canada, interdisciplinary support groups (ISGs) are mandated to support those who are involved in the clinical, administrative, legal and ethical aspects of medical assistance in dying (MAiD). This article presents the results of a mixed-method, multi-phase study carried out in 2021 on ISGs with the aim to describe current ISG practices, critically analyze them and make recommendations on promising practices for provincial implementation. Method: Semi-structured interviews (42) and focus groups (7) with coordinators of 24 ISGs were used to identify promising practices and confirm their utility with participants. Results: We have distributed the ISGs along what we coined an "ISG continuum." Between teams' accountability (decentralization) and ISGs' assumption of responsibility for MAiD requests (centralization), a middle ground approach, focused on the value of support, should be favored. Conclusion: The structuring of ISGs and their practices is intimately linked to their values. Harmonization of ISGs and their practices, while considering their specific values and contexts, can contribute to the equity and quality of services intended for those who request MAiD and those who support them.

Factors Associated With Treatment Escalation for Psoriasis: An Analysis of Electronic Health Records Data.

Background: Electronic health records (EHRs) offer the possibility of using data entry templates to simultaneously document routine clinical care and capture disease-specific measures as discrete data elements that can be used for health services research (HSR). The objective of this study was to determine factors associated with meaningful treatment escalation (MTE) of psoriasis as a pilot study for future real-world HSR studies. Methods: We conducted a retrospective, observational cohort study of psoriasis patients by using data collected during routine clinical care from an EHR using EpiCare® SmartForms. The psoriasis SmartForm records psoriasis disease severity measures and descriptive findings to generate visit notes. These data were extracted and analyzed to identify factors associated with MTE, defined as changing or adding, phototherapy, systemic, or biologic therapy. Results: 473 psoriasis patients met study criteria; 239 underwent MTE between their first and third observed visits. Patients who experienced MTE had more severe disease at Visit 1-assessed by BSA, pPGA, oPGA, and a patient-reported disease severity measure--than patients who did not experience MTE. Other factors associated with MTE included use of topicals only or no active treatment at Visit 1, palmoplantar disease, and involvement of other difficult-to-treat body areas. Patients who underwent MTE experienced larger improvements in disease severity than those who did not. Conclusions: This study highlights how data collected during routine clinical practice can be readily used for real-world retrospective HSR when disease measures are captured as discrete elements. This approach could provide a cost-effective platform to conduct real-world HSR.

Implementing a pragmatic randomised controlled trial in a humanitarian setting: lessons learned from the TISA trial.

INTRODUCTION: High-quality evidence is crucial for guiding effective humanitarian responses, yet conducting rigorous research, particularly randomised controlled trials, in humanitarian crises remains challenging. The TISA ("traitement intégré de la sous-nutrition aiguë") trial aimed to evaluate the impact of a Water, Sanitation and Hygiene (WASH) intervention on the standard national treatment of uncomplicated Severe Acute Malnutrition (SAM) in children aged 6-59 months. Implemented in two northern Senegalese regions from December 22, 2021, to February 20, 2023, the trial faced numerous challenges, which this paper explores along with the lessons learned. METHODS: The study utilised trial documentation, including field reports, meeting minutes, training plans, operational monitoring data and funding proposals, to retrace the trial timeline, identify challenges and outline implemented solutions. Contributions from all TISA key staff-current and former, field-based and headquarters-were essential for collecting and interpreting information. Challenges were categorised as internal (within the TISA consortium) or external (broader contextual issues). RESULTS: The TISA trial, executed by a consortium of academic, operational, and community stakeholders, enrolled over 2000 children with uncomplicated SAM across 86 treatment posts in a 28,000 km2 area. The control group received standard outpatient SAM care, while the intervention group also received a WASH kit and hygiene promotion. Initially planned to start in April 2019 for 12 months, the trial faced a 30-month delay and was extended to 27 months due to challenges like the COVID-19 pandemic, national strikes, health system integration issues and weather-related disruptions. Internal challenges included logistics, staffing, data management, funding and aligning diverse stakeholder priorities. DISCUSSION AND CONCLUSION: Despite these obstacles, the trial concluded successfully, underscoring the importance of tailored monitoring, open communication, transparency and community involvement. Producing high-quality evidence in humanitarian contexts demands extensive preparation and strong coordination among local and international researchers, practitioners, communities, decision-makers and funders from the study's inception. TRIAL REGISTRATION: Clinicaltrials.gov NCT04667767 .

Estimating dengue disease and economic burden to inform municipal-level policymakers: Method for a pragmatic city-level observational cohort study.

Background: Recent trials have confirmed the effectiveness of promising dengue control technologies - two vaccines and Wolbachia. These would generally be applied at the municipal level. To help local officials decide which, if any, control strategy to implement, they need affordable, timely, and accurate data on dengue burden. Building on our previous work in Mexico, Indonesia, and Thailand, we developed a streamlined prospective method to estimate dengue burden at the municipal level quickly, accurately, and efficiently. Methods: The method entails enrolling and repeatedly interviewing 100 patients with laboratory-confirmed dengue. They will be selected after screening and testing about 1,000 patients with clinical dengue. The method will capture both acute and chronic effects relating to disease, economic burden, and psychological impacts (presenteeism). The total time requirements are 1.5 years, comprised of 0.25 years for planning and approvals, 1 year for data collection (a full dengue cycle), and 0 .25 years for data cleaning and analysis. A collaboration with municipal and academic colleagues in the city of Semarang, Central Java, Indonesia shows how the method could be readily applied in Indonesia's eighth largest city (population 1.8 million). Conclusions: Many surveillance studies gather only information on numbers of cases. This proposed method will provide a comprehensive picture of the dengue burden to the health system, payers, and households at the local level.

Poor sample size reporting quality and insufficient sample size in economic evaluations conducted alongside pragmatic trials: A cross-sectional survey.

OBJECTIVES: Economic evaluation outcomes are seldom taken into consideration during the process of sample size calculation in pragmatic trials. The reporting quality of sample size and information on its calculation in economic evaluations well suited to pragmatic randomized controlled trials (pRCTs) remain unknown. This study aims to assess the sample size and power of economic evaluations in pRCTs. STUDY DESIGN AND SETTING: We conducted a cross-sectional survey using data of pRCTs available from PubMed and OVID from 1 January 2010 to 24 April 2022. Two groups of independent reviewers identified articles; three groups of reviewers each extracted the data. Descriptive statistics presented the general characteristics of included studies. Statistical power analyses were performed on clinical and economic outcomes with sufficient data. RESULTS: The electronic search identified 715 studies; 152 met the inclusion criteria and, of these, 26 were available for power analysis. Only 9 out of 152 trials (5.9%) considered economic outcomes when estimating sample size, and only one adjusted the sample size accordingly. Power values for trial-based economic evaluations, and clinical trials ranged from 2.56% to 100%, 3.21% to 100%, respectively. Regardless of the perspectives, in 14 among 26 studies (53.8%), the power values of economic evaluations for quality-adjusted life years (QALYs) were lower than those of clinical trials for primary endpoints (PEs). In 11 out of 24 (45.8%) and 8 from 13 (61.5%) studies, power values of economic evaluations for QALYs were lower than those of clinical trials for PEs from the healthcare and societal perspectives, respectively. Power values of economic evaluations for non-QALYs from the healthcare and societal perspectives were potentially higher than those of clinical trials in 3 from a total of 4 studies (75%). The power values for economic outcomes in Q1 were not significantly higher than those for other journal impact factor quartile categories. CONCLUSIONS: Theoretically, pragmatic trials with concurrent economic evaluations can provide real-world evidence for healthcare decision makers. However, in pRCT-based economic evaluations, limited consideration and inadequate reporting of sample-size calculations for economic outcomes could negatively affect the results' reliability and generalisability. To avoid misleading decisions made based on study results, we recommend that future pragmatic trials with economic evaluations should report how sample sizes are determined or adjusted based on the economic outcomes in their protocols to enhance their transparency and evidence quality.

How the cost of veterinary care impacts the wellbeing, learning and practice of early career vets.

BACKGROUND: Investigations by the Competition and Markets Authority into the veterinary sector have highlighted the cost of veterinary care. This paper examines the changing attitudes of early career vets towards these costs. METHODS: Ninety-seven semi-structured interviews were held with 25 vets as part of a 2.5-year longitudinal study. An inductive approach to analysis was adopted with flexible thematic analysis being undertaken using NVivo 12. RESULTS: High veterinary care costs create a financial burden for clients and an emotional burden for vets. Vets felt unprepared to deal with restricted client budgets and were unsupported by their practices in relation to charging. When owners could not afford treatment, vets had fewer opportunities to perform procedures and practise their skills. Eventually, vets distanced themselves from their clients' circumstances to prioritise their own wellbeing and began to value their expertise and charge appropriately. LIMITATIONS: The small sample size and emphasis on graduates of UK universities limit the generalisability of the findings. CONCLUSION: This paper highlights the impact of veterinary care costs on early career vets' wellbeing, practice and learning opportunities and advocates a 'spectrum of care' approach to veterinary education. It also encourages practices to engage with vets regarding charging behaviours.

"I think we just saw happier residents": nursing home provider reported readiness assessment of the individualized positive psychosocial interaction (IPPI) program.

OBJECTIVES: This study assessed the readiness of The Individualized Positive Psychosocial Interaction (IPPI) program in the nursing home (NH) setting from the perspective of NH providers implementing the IPPI. The evidence-based IPPI program is designed to help remediate distress and improve mood for residents living with dementia. NH staff are trained to engage residents in brief (i.e. 10-min) one-to-one, preference-based activities to alleviate emotional distress and enhance quality of life. METHOD: NH providers (n = 15) who championed the IPPI implementation completed an exit interview based on the nine domains of the Readiness Assessment for Pragmatic Trials (RAPT). Interviews were audio-recorded, transcribed, and coded by RAPT domains, then scored by the research team to reflect an average for each domain. RESULTS: Providers rated the IPPI program's readiness high on the domains of alignment, impact, risk, implementation protocol, evidence, cost, and acceptability. The domains of measurement and feasibility scored lower, likely due to broader contextual issues and require particular attention. CONCLUSION: Results illustrate that the IPPI program successfully aligns with stakeholder priorities, is a safe intervention with minimal risk, and has beneficial outcomes. The IPPI's low cost, design, and alignment with organizational goals also facilitated implementation while measuring outcomes and staffing considerations impacted organizational capacity for implementation.

A protocol for stakeholder engagement in head and neck cancer pragmatic trials.

Meaningful engagement with stakeholders in research demands intentional approaches. This paper describes the development of a framework to guide stakeholder engagement as research partners in a pragmatic trial proposed to evaluate behavioral interventions for dysphagia in head and neck cancer patients. We highlight the core principles of stakeholder engagement including representation of all perspectives, meaningful participation, respectful partnership with stakeholders, and accountability to stakeholders; and describe how these principles were operationalized to engage relevant stakeholders throughout the course of a large clinical trial.

Pharmacopuncture therapy for adhesive capsulitis: A pragmatic randomized controlled pilot study.

Background: Although several studies have reported the effectiveness of acupuncture treatment for adhesive capsulitis (AC), research on pharmacopuncture therapy for AC remains limited. We compared the effectiveness and safety of pharmacopuncture and physiotherapy for AC. Methods: This pragmatic, randomized, controlled, parallel-group pilot study enrolled patients with limitations of shoulder movement and a numeric rating scale (NRS) score for shoulder pain ≥5 randomized (1:1) to the pharmacopuncture therapy (PPT) and physiotherapy (PT) groups. Treatment sessions were administered twice weekly for 6 weeks, and the participants were followed up for 13 weeks after randomization. The primary outcome was the NRS score for shoulder pain, and the secondary outcomes were the visual analog scale (VAS), Shoulder Pain and Disability Index (SPADI), range of motion (ROM), patient global impression of change (PGIC), EuroQol 5-Dimension 5-Level (EQ-5D-5L), and Short Form 12 Health Survey (SF-12) scores. The intention-to-treat (ITT) analysis was set as the primary analysis. Results: Among 50 participants, for the primary endpoint (week 7) the PPT group showed a significantly superior improvement in NRS, VAS, SPADI, ROM for flexion, ROM for abduction, and EQ-5D-5L scores. The ROM for extension, ROM for adduction, physical component summary, and patient global impression of change were significantly better in the PPT than in the PT group, and these effects were sustained until week 13. Conclusion: In this pilot study, PPT showed better effects than PT, confirming the feasibility of a follow-up main study. Trial registration: Clinicaltrials.gov (NCT05292482) and cris.nih.go.kr (KCT0007198).

Addressing emotional distress to improve outcomes in adults with type 1 diabetes: Protocol for ACT1VATE randomized controlled trial.

BACKGROUND: Diabetes distress (DD) is a prevalent concern among people with type 1 diabetes (T1D) and is linked to poor clinical outcomes. Instead of targeting the elimination of DD, we propose a novel approach that empowers individuals with strategies to manage their diabetes effectively in the context of DD: Acceptance and Commitment Therapy (ACT). The purpose of this in-progress trial is to compare an ACT group intervention (ACT1VATE) with usual care in improving HbA1c, DD, quality of life, and cost-effectiveness in adults with T1D. METHODS: This is a two-arm, parallel group, randomized controlled superiority trial enrolling N = 250 adults with T1D, elevated HbA1c, and significant DD in a real-world community-based health system. Participants are randomized to receive ACT1VATE (a five-week ACT group telehealth intervention) or diabetes self-management education and support (usual care as the first-line recommended intervention for DD). The trial will examine comparative effectiveness in improving HbA1c, DD, quality of life, and cost-effectiveness over 12 months. DISCUSSION: We predict that ACT1VATE will be superior given its (1) specific focus on DD, without any expectation that difficult diabetes-related thoughts and emotions must (or can) be completely eliminated; and (2) purposeful linkage of diabetes self-care behaviors to an individual's deeply held values, thus eliciting intrinsic, patient-centric motivation for meaningful and lasting health behavior changes. This trial will provide a valuable test of real-world effectiveness, drive sustainability and scalability, and inform the future of chronic disease care. TRIAL REGISTRATION: NCT04933851 (https://clinicaltrials.gov/ct2/show/NCT04933851). CLINICAL TRIAL: Clinicaltrials.govNCT04933851https://clinicaltrials.gov/study/NCT04933851.

Understanding why restrictive trial eligibility criteria are inappropriate.

BACKGROUND: An important difference between explanatory and pragmatic clinical trials concerns eligibility criteria. Eligibility criteria are restrictive in explanatory trials, while pragmatic trials are more inclusive or even all-inclusive. METHODS: To better understand the diverging views regarding eligibility criteria, we examine the contrast between theoretical and clinical medicine, and 3 different research contexts: laboratory research, population studies and clinical trials. In each context we review the purpose for selecting study subjects or research material, as well as the type of inductive inference or generalization that is sought by such selection. RESULTS: In each context, selection concerns different things and serves different purposes: In the laboratory, selection concerns the homogenous research material that will help isolate a causal signal. In the epidemiological context selection concerns the (random) sampling method, designed to produce a representative sample of the population. In the clinical trial setting, selection concerns patients in need of care. Restrictive eligibility criteria become inappropriate in the care setting because the aim of the trial is not to represent a population nor to isolate a causal signal, but to find out which patients benefit from treatment. CONCLUSION: The idea of selecting patients comes from methods that belong to theoretical medicine. In the care setting, most clinical trials should be pragmatic and as inclusive as possible.

Community-engaged implementation of a safety bundle for pregnancy-related severe hypertension in the outpatient setting: protocol for a type 3 hybrid study with a multiple baseline design.

BACKGROUND: Hypertensive disorders of pregnancy are among the leading causes of maternal mortality and morbidity in the U.S., with rates highest among birthing people who are Black, rural residents, and/or have low-income. Severe hypertension, in particular, increases risk of stroke and other serious pregnancy complications. To promote early detection and treatment of severe hypertension, the Alliance for Innovation on Maternal Health developed the Severe Hypertension During Pregnancy and Postpartum Period Safety Bundle (HTN Bundle). Multiple studies have demonstrated the HTN Bundle's effectiveness in the inpatient setting. With funding from the National Heart, Lung, and Blood Institute, we engaged community partners to adapt the HTN Bundle for the outpatient setting (i.e., O-HTN Bundle) and planned for its implementation. In this paper, we describe the protocol for a study evaluating O-HTN Bundle implementation in 20 outpatient clinics serving Black, rural, and/or low-income populations. METHODS: This study is a hybrid type 3 effectiveness-implementation trial with a multiple baseline design. We will implement the O-HTN Bundle in three successive cohorts of clinics using a multicomponent implementation strategy to engage community partners (coalition, patient workgroup) and support clinics (training, facilitation, education materials, and simulations of severe hypertension events). To test the strategy, we will compare clinic fidelity to evidence-based guidelines for (a) patient education on hypertension and (b) blood pressure measurement technique, with repeated measures occurring before and after strategy receipt. We will also observe strategy effects on community- and clinic-level intermediate outcomes (community engagement, organizational readiness), implementation outcomes (reach, adoption, fidelity, maintenance), and effectiveness outcomes (receipt of guideline concordant care). Analyses will address whether outcomes are equitable across Black, rural, and/or low-income subgroups. Guided by the Consolidated Framework for Implementation Research 2.0, we will use mixed methods to identify adaptations and other determinants of implementation success. DISCUSSION: This study integrates community engagement and implementation science to promote equitable and timely response to severe HTN in the outpatient setting during pregnancy and postpartum. This is one of the first studies to implement an outpatient HTN Bundle and to use simulation as a strategy to reinforce team-based delivery of guideline concordant care. TRIAL REGISTRATION: This study was registered with ClinicalTrials.gov as "Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle (AC3HIEVE)." Registration number NCT06002165, August 21, 2023: https://clinicaltrials.gov/study/NCT06002165 .

Pragmatic Clinical Trials for Dementia Care: Experience from the First 5 Years of the IMPACT Collaboratory.

The IMPACT Collaboratory is a national infrastructure and resource dedicated to transforming dementia care in real-world environments for millions of Americans and their care partners, using embedded pragmatic clinical trials. This new approach of applied clinical research holds the promise of accelerating the science of dementia care, improving relevancy of interventions to real-world partners, promoting health equity, and closing the gaps between research, everyday clinical practice, and lived experiences of people living with dementia and their care partners.