Patient Focus Groups Research Articles

P0450 World-wide Development and Validation of the IBD LIFE Questionnaire and Country-specific Patterns of Normal Life Impairment

Abstract Background For patients with inflammatory bowel diseases (IBD), the ultimate goal is to live a ‘normal life’, yet no validated patient-reported outcome measure (PROM) exists to assess this. We aimed to develop and validate a globally relevant PROM to assess the impact of IBD on normal life through a world-wide, patient-centred approach, the ‘IBD LIFE’. Methods Patients with Crohn’s disease (CD) or ulcerative colitis (UC) from Argentina, Australia, India, the Netherlands, South Korea, and the USA without ostomies, pouches, or significant comorbidities were eligible. The development phase involved (A) patient interviews, (B) a Delphi consensus, (C) patient focus groups, (D) pilot-testing, and (E) cross-cultural translation, resulting in a 23-item PROM with five domains: physical, activities, social, psychological, and circumstances. For the validation phase, CD and UC patients speaking Dutch, English, and Spanish were recruited (n=100 per disease, per language). IBD LIFE and generic and IBD-specific quality of life (QoL) PROMs ((Short-From-36 (SF-36) and IBD Questionnaire (IBDQ)) were administered at baseline, 2 weeks (n=30 per language) and ≥8 weeks. Clinical disease activity was measured at baseline and ≥8 weeks using Harvey Bradshaw Index (HBI) for CD and Simple Clinical Colitis Activity Index (SCCAI) for UC. Construct validity was tested through correlations between baseline indices, repeatability using intraclass correlation coefficient (ICC) in patients with stable QoL at 2 weeks, and responsiveness through a Receiver Operating Characteristic curve analysis for detection of a clinically meaningful change in IBDQ at ≥8 weeks. Country-specific normal life impairment patterns were assessed using total IBD LIFE scores and domain weights. Results Among 605 patients (300 CD/305 UC, table 1), IBD LIFE’s construct validity was supported by strong correlations with QoL indices (IBDQ r=-0.90; SF-36 r=-0.83), and moderate correlations with clinical disease indices (HBI r=0.52; SCCAI r=0.51). IBD LIFE showed strong repeatability (ICC=0.91) and responsiveness (AUC=0.873). IBD LIFE scores ranged from 0-90 (mean 18.51 ± 18.73), with higher scores being associated with more impairment on normal life. Physical and psychological domains had most impact on patients’ lives (indicated by highest domain weights, figure 1). USA patients had the lowest IBD LIFE score compared to other countries (mean 12.27 ± 14.20; P<0.001), yet showed disproportionately higher impact in the physical domain and lower impact in activities (Figure 1). Conclusion IBD LIFE, developed with extensive patient involvement, is a valid PROM of IBD’s impact on normal life. It allows tailored patient support to achieve normal life across all life domains affected by IBD.

DOP084 Development of a core outcome set for Inflammatory Bowel Disease patients with stomas

Abstract Background A significant number of patients with Inflammatory Bowel Disease (IBD) undergo surgery resulting in a stoma. For many, an ostomy is not curative. Patients may continue to experience disease exacerbations and require continued medical therapies. Despite this, patients with IBD and stomas are excluded from clinical trials, largely due to the heterogeneity in outcomes and the lack of validated measurement tools for this cohort. The TOAST-IBD project aimed to address this issue by developing a Core Outcome Set (COS) for IBD patients with stomas. Methods A long-list of candidate outcomes was generated through a systematic review and patient focus groups. Consensus was established via a two-round Delphi process using a 9-point Likert scale based on how important candidates felt it was in determining treatment success. This was followed by a final consensus meeting. Stakeholders were recruited internationally and grouped into 4 panels (patients, specialist and research nurses, colorectal surgeons, and gastroenterologists). Participants received feedback from their panel in the first round and from all participants in the second round to allow refinement of their scores. Results A total of 68 outcomes were extracted via a systematic review of the existing literature and an additional 11 unique outcomes were added from 4 90-minute online patient focus groups. A further 9 outcomes were proposed by the study working group, generating a total of 88 outcomes to be included in the voting process. 76 stakeholders (73.1% response rate) from 17 countries carried forward 37 outcomes through a two-round Delphi process. The final consensus meeting of 37 experts and patients agreed on a six domain COS. The COS included the maintenance of hydration and volume status, the maintenance of nutritional status, symptom-based clinical activity, objective marker-based disease activity and two quality of life (QOL) domains (IBD-related QOL and stoma-specific QOL). Adverse effects from treatment did not reach a consensus to be included in the core outcome set but was considered important to be captured where applicable. Conclusion An IBD Stoma COS has been produced by all key stakeholders. This COS will serve as the foundation for development of relevant measurement instruments for IBD patients with stomas so as to include this underrepresented cohort in future clinical trials.

Stroke Rehabilitation: Synopsis of the 2024 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guidelines.

In July 2024, the U.S. Department of Veterans Affairs (VA) and U.S. Department of Defense (DOD) released a joint update of their 2019 clinical practice guideline (CPG) for the management of stroke rehabilitation. This synopsis is a condensed version of the 2024 CPG, highlighting the key aspects of the guideline development process and describing the major recommendations. The VA/DOD Evidence-Based Practice Work Group convened a joint VA/DOD guideline development work group (WG) that included clinical stakeholders and conformed to the Institute of Medicine's tenets for trustworthy CPGs. The guideline WG conducted a patient focus group, developed key questions, and systematically searched and evaluated the literature (English-language publications from 1 July 2018 to 2 May 2023). The GRADE (Grading of Recommendations Assessment, Development and Evaluation) system was used to evaluate the evidence. The WG developed 47 recommendations along with algorithms for stroke rehabilitation in the inpatient and outpatient settings. Stakeholders outside the WG reviewed the CPG before approval by the VA/DOD Evidence-Based Practice Work Group. This synopsis summarizes where evidence is strongest to support guidelines in crucial areas relevant to primary care physicians: transition to community (case management, psychosocial or behavioral interventions); motor therapy (task-specific practice, mirror therapy, rhythmic auditory stimulation, electrical stimulation, botulinum toxin for spasticity); dysphagia, aphasia, and cognition (chin tuck against resistance, respiratory muscle strength training); and mental health (selective serotonin reuptake inhibitor use, psychotherapy, mindfulness-based therapies for treatment but not prevention of depression).

Unmet Needs in the Management of Chronic Kidney Disease-Associated Pruritus and the Characteristics of the Ideal Treatment: A Spanish Cross-Sectional Survey from a Multidisciplinary Perspective.

Objectives: Chronic kidney disease-associated pruritus (CKD-aP) is underdiagnosed and not fully understood by healthcare professionals, which leads to poor patient management and impacts patients' quality of life (QoL). The aim of this study was to analyse unmet needs in CKD-aP management and explore the attributes/characteristics that the ideal CKD-aP treatment should have from the perspective of a group of nephrologists, hospital pharmacists, nurses, patient representatives, and regional health authorities in Spain. Methods: A descriptive, cross-sectional study was conducted using an e-survey including ad hoc questions (6-point Likert scale) related to unmet needs in CKD-aP and best-worst scaling (BWS) to prioritise the attributes/characteristics of the ideal CKD-aP treatment. The survey was developed from a literature review, a patient focus group, and a multidisciplinary expert committee. Results: A total of 21 people participated, and it was considered, among other aspects, that CKD-aP had a significant impact on patient QoL (4.29/5), but the diagnosis rate and knowledge level of agents involved, as well as current treatment efficacy and safety, were low (1.71/5, 2.19/5, 1.91/5, and 2.67/5, respectively). The attributes "improves overall QoL (physical and mental)", "reduces itch with statistical significance", and "treatment is supported by clinical development/high evidence and has AEMPS (Spanish Agency for Medicines and Medical Devices)-approved indication for pruritus" were selected as the most valued attributes. There was a positive balance between best-worst scores (86-5, 71-2, and 78-13 points, respectively). Conclusions: The results show the need to undertake actions to drive relevant changes in current clinical practice to improve CKD-aP diagnosis and management.

How can we remove erroneous penicillin allergy labels?

To evaluate the use of the Penicillin Allergy Reassessment for Treatment Improvement (PARTI) tool in supporting appropriate penicillin allergy labelling in dental practices. Parallel mixed methods study. Focus groups of patients with documented penicillin allergies and healthcare worker targeted questionnaires were used in gathering feedback on the PARTI tool's design and functionality. Transcriptions of the focus group discussions and free text answers from the questionnaires were coded for analysis using a modified grounded theory approach. A total of 15 patients engaged in the focus groups and 50 healthcare workers responded to the questionnaire. Mean age of the patients was 52 years and 53.3% were female. Most patients (73.3%) had visited a dentist in the preceding year and 86.6% were asked about drug allergies. Healthcare worker respondents included 30% pharmacists and dentists, dental hygienists, and dental assistants (28%). Feedback from patients and healthcare workers on the PARTI tool was constructive and suggestions were made for improvement. Many healthcare workers (68%) highlighted the importance of the section on penicillin allergy testing in the PARTI tool. Feedback from the participants was incorporated into the final PARTI tool. Feedback from patients and healthcare workers was used to finalise a tool for dental practices to enhance dentist-patient communications regarding penicillin allergy.

The MyLungHealth study protocol: a pragmatic patient-randomised controlled trial to evaluate a patient-centred, electronic health record-integrated intervention to enhance lung cancer screening in primary care

IntroductionEarly lung cancer screening (LCS) through low-dose CT (LDCT) is crucial but underused due to various barriers, including incomplete or inaccurate patient smoking data in the electronic health record and...

Service Delivery Redesign for Noncommunicable Disease Management: Assessment of Needs and Solutions Through a Co-Creation Process in Argentina.

In Argentina, the implementation of a national strategy to reduce the prevalence of noncommunicable diseases (NCDs) has been hampered by challenges at the provincial level. We aimed to design a new model of care for NCDs at the primary care level by conducting a multimodal system assessment and co-design of potential solutions in the province of Mendoza. We carried out a mixed-methods study with 7 components: evaluation of patterns of care, patient focus groups, cross-sectional standardized population-based phone survey, an electronic cohort follow-up of patients with type 2 diabetes, in-depth interviews with stakeholders, a knowledge test for health care providers on chronic condition management, and a Delphi consensus to provide recommendations from stakeholders. Focus group and in-depth interviews revealed access to primary health care for NCDs was associated with problems with long waiting times and time-consuming procedures for referral to laboratory tests, hospital care, and provision of medication. Mental health care services were particularly limited. Survey respondents (N=1,190) were predominantly covered through public (41%) or social security sectors (54%); 41% fell in the lowest income group. Contact with the health system was high (5.7 annual visits), but 19.7% reported unmet health care needs. Public sector providers perceived they provided high-quality care despite insufficient material and human resources. Within the social security sector, the main challenge was insufficient staff, particularly affecting mental health care. Health care providers showed a higher percentage of correct answers to depression-related questions, but worse results were seen in hypertension and diabetes care. Actions supported by evidence and expert agreement were identified for implementation to guide future system changes. Our research highlights the potential for Argentina's primary care system to initiate transformative, system-level changes aimed at improving health outcomes. We propose an innovative methodological assessment and co-design for improving primary care.

Perspectives of clinicians and screening candidates on shared decision-making in prostate cancer screening with the prostate-specific antigen (PSA) test: a qualitative study (PROSHADE study)

ObjectiveThe objective of this study is to analyse the perspectives of screening candidates and healthcare professionals on shared decision-making (SDM) in prostate cancer (PCa) screening using the prostate-specific antigen (PSA) test.DesignDescriptive qualitative study (May–December 2022): six face-to-face focus groups and four semistructured interviews were conducted, transcribed verbatim and thematically analysed using ATLAS.ti software.SettingData were obtained as part of the project PROSHADE (Decision Aid for Promoting Shared Decision Making in Opportunistic Screening for Prostate Cancer) to develop a tool for SDM in PCa screening with PSA testing in Spain.ParticipantsA total of 27 screening candidates (three groups of men: 40–50 years old; 51–60 years old and 61–80 years old), 25 primary care professionals (one group of eight nurses and two groups of physicians: one with more and one with less than 10 years of experience), and four urologists. Focus groups for patients and healthcare professionals were conducted separately.Main outcome measuresParticipants' perceptions of shared decision-making related to PSA opportunistic screening, including their understanding, preferences, and attitudes.ResultsThree themes were generated: (1) perceptions of SDM, (2) perceptions of PSA testing and (3) perceptions of SDM regarding PCa screening. Theme 1: screening candidates valued SDM when it included clear information and empowered them. There was consensus with primary care health professionals on this point, although their knowledge and implementation of SDM varied. Theme 2: candidates were divided on PSA testing; some trusted it for early detection, while others expressed scepticism due to concerns about false positives and invasive procedures, reflecting gaps in accessible information. Theme 3: professionals across primary and specialised care stressed the need for standardised SDM protocols. Primary care physicians were particularly concerned that PSA decisions align with scientific evidence and urologists recognised SDM as valuable in PSA testing only if it was adequately explained to each patient. Barriers to implementing SDM included insufficient coordination across care levels, lack of consensus-driven protocols and limited clinical time.ConclusionsWhile patients expect comprehensive information, primarily based on practice to achieve empowerment, healthcare professionals face obstacles such as limited time and insufficient coordination between primary care and urology. All stakeholders agree on the importance of evidence-based tools to reinforce effective SDM and enhance collaboration across urologists and primary care in the context of PSA testing.

Development of ICF-based patient-reported outcome and experience measures to study social participation among people with chronic diseases: a mixed-methods protocol

IntroductionLiving with a chronic disease impacts many aspects of life, including the ability to participate in activities that enable interactions with others in society, that is, social participation (SP). Despite...

Access to medicines for the treatment of chronic diseases in Chile: qualitative analysis of perceived patient barriers and facilitators in five regions of the country

BackgroundAccess to medicines is one of the most serious public health problems globally, and Chile is not an exception. The aim of this study was to explore patients' perceptions, beneficiaries of both public and private health sectors, of barriers and facilitators in access to medicines in general, and those associated with the treatment of diabetes, dyslipidemia and hypertension.MethodsTen focus groups of patients with these diseases, diagnosed for at least six months and with prescribed medication, were carried out in five regions of Chile: Arica (north), Aysén (south), and Valparaíso, Metropolitan, and Maule (center).ResultsThe experience of access to medicines is determined by the insurance system, the experience of care with public or private providers, and geographical-administrative difference between capital and other regions. Beneficiaries of public sector value territorial coverage of primary care, which guarantees access in isolated areas and, despite their greater socioeconomic vulnerability, perceive greater protection in access (access conditions, delivery reliability and adherence to pharmacological treatment). The main problem observed is the financing of treatments not covered by the system. Beneficiaries of private sector perceive that they have access to medicines of better quality than those provided free of charge by public sector, but raise fears associated with the inability to afford them and distrust in the market process. Regarding the type of provider, public sector shows greater capacity for user loyalty, which is expressed in regular visits and follow-up, unlike discontinuous examinations among private sector beneficiaries.ConclusionsDifferent access conditions both at the territorial level and in the health subsystems are evident. It is necessary to make progress in addressing the problem of access to medicines in a comprehensive manner.

Mission and Future Plans for the ADPKD Centers of Excellence Program.

The Autosomal Dominant Polycystic Kidney Disease (ADPKD) Centers of Excellence Program, launched by the Polycystic Kidney Disease Foundation in 2022, aims to bridge the gap in specialized care for individuals with ADPKD. This program seeks to enhance the availability of specialized clinicians and simplify the process for patients seeking expert care. It is founded on three pillars: improving care for all individuals with ADPKD, educating and empowering the community, and advancing PKD research. The program draws inspiration from successful models in other diseases, such as cystic fibrosis and muscular dystrophy, which have demonstrated the effectiveness of standardized care centers in improving patient outcomes. Patient and clinician stakeholder interviews have identified key areas where a national program could make a significant impact, including the need for a core care team with defined referral processes, mentorship and shared care models, patient navigation services, and education around expert consensus and care guidelines. The program introduces two designations: "Center of Excellence" and "Partner Clinic" to accommodate diverse care settings and enhance patient access to specialists. The Partner Clinic designation ensures that patients in smaller community practices have access to specialized care through mentorship and guidance from experts at Centers of Excellence. The program also emphasizes the importance of specialized services, especially in underserved communities experiencing health disparities, to manage the complexities of ADPKD care. Patient focus groups have highlighted the need for care navigation services, centralized sources of knowledge, and access to local care. The program aims to address these needs by providing a structured framework for care coordination, enhancing patient self-advocacy, and improving overall outcomes for individuals with ADPKD.

Why Collect and Use Race/Ethnicity Data? A Qualitative Case Study on the Perspectives of Mental Health Providers and Patients During COVID-19.

Calls to collect patients' race/ethnicity (RE) data as a measure to promote equitable health care among vulnerable patient groups are increasing. The COVID-19 pandemic has highlighted how a public health crisis disproportionately affects racialized patient groups. However, less is known about the uptake of RE data collection in the context of mental health care services. A qualitative case study used surveys with mental health patients (n = 47) and providers (n = 12), a retrospective chart review, and a focus group to explore healthcare providers' and patients' perspectives on collecting RE data in Canada. The patient survey data and focus groups show that patients avoid providing identifying information due to perceived stigma and discrimination and a lack of trust. Providers did not feel comfortable asking patients about RE, leading to chart review data where RE information was not systematically collected. The uptake and implementation of RE data collection in mental health care contexts require increased training and support, systematic implementation, and further evaluation and measurement of how the collection of RE data will be used to mitigate systemic racism and improve mental health outcomes.

Synopsis of the 2023 U.S. Department of VA and U.S. DoD Clinical Practice Guideline for the Management of Pregnancy.

This Clinical Practical Guideline provides recommendations based on a systematic review of the evidence to address critical decision points in the management of pregnancy. The guideline is intended to improve patient outcomes and local management of patients who are pregnant. This CPG is based on a systematic review of both clinical and epidemiological evidence and was developed by a panel of multidisciplinary experts. The Work Group provides clear and comprehensive evidence-based recommendations incorporating current information and practices targeting practitioners throughout the DoD and VA Health Care systems. The guideline is intended to improve patient outcomes and local management of patients who are pregnant. This CPG does not address every aspect of routine pregnancy care and is not intended to be a comprehensive guide to all care needed in pregnancy. It also addresses some clinically important and generally accepted standards of pregnancy care interventions that do not have sufficient high-quality evidence to support standalone recommendations. Additionally, it highlights emerging topics that have the potential to impact pregnancy care in the future and identifies gaps in the literature that warrant further research. The development of all VA/DoD guidelines is directed by the Evidence-Based Practice Guideline Work Group and adheres to the standards for trustworthy guidelines that were set by the National Academy of Medicine. A patient focus group was convened to assess important aspects of treatment for patients and to gain information about patient values and preferences. The Lewin Group, a contracted third party with expertise in CPG development, facilitated meetings and the development of key questions using the population, intervention, comparison, outcome, timing, and setting format. Consensus was achieved among the Work Group through an iterative process involving discussions on conference calls and in person during the recommendation development meeting. An independent third party, ECRI, conducted the systematic evidence review, which the guideline Work Group then used to develop recommendations using the Grading of Recommendations Assessment, Development and Evaluation system (7-9). The search methods and results are detailed in the full guideline. This CPG provides 28 clinical practice recommendations that cover selected topics that the Work Group deemed had high priority need for evidence-based standards. The recommendations are divided into 3 main categories: routine care, complicated obstetrics, and mental health. An algorithm delineating recommended interventions and appropriate timing of these interventions over the course of the pregnancy and postpartum period was also created. The CPG is not intended to define standards of care nor address all care needed in pregnancy; it does provide comprehensive guidance for routine pregnancy care. It aligns with the VA and DOD's goal of providing care that is consistent in quality and utilization of resources in efforts to reduce errors and inappropriate variations in practices. In total, the Work Group identified 71 items needing further study, including areas requiring stronger evidence to support current recommendations and newer topics that will guide future guideline development.

Development and Validation of the Decisions to use Opioids Measure

BackgroundMillions experience inadequately managed acute pain each year. Opioids are an important tool for managing pain; however, recent reductions in opioid prescriptions have exacerbated preexisting challenges in pain management. Moreover, patient expectations and desires for pain management may drive additional opioid use. There is an important need to characterize patient motivations for using opioids in order to develop promising interventions. The aim of this study was to develop the Decisions To use Opioids (DTO) measure. MethodsWe used an exploratory sequential mixed methods design to create items for the DTO measure. Qualitative data from patient interviews and focus groups informed the development of items for the DTO. We evaluated the content validity of candidate items with nine experts using the content validity index (CVI) and conceptual significance. Face validity was assessed via cognitive interviews with five emergency department (ED) participants who experienced acute pain. ResultsWe generated an initial pool of 52 items. Expert ratings provided evidence of content validity on 40 items, as indicated by an item CVI score of 0.83 or higher. Nine items with CVI scores of <0.83 were retained and revised due to the conceptual significance. The remaining three items were discarded. ConclusionsThis study provided evidence of content and face validity of the DTO measure for ED patients. Further psychometric evaluation is needed to gather data regarding the DTO's internal consistency, construct validity, and criterion validity.

Single-encounter elicitation framework for diagnostic excellence patient-reported measures: SEE-Dx-PRM

ObjectiveTo create a conceptual framework for assessing patient-reported diagnostic excellence of a single diagnostic encounter. MethodsWe held multiple expert panel meetings to prioritize a priori identified diagnostically relevant patient-reported experience and outcome domains. We combined and synthesized expert feedback with our experience in measure development and the reflections of a patient focus group. We then developed the framework, SEE-Dx-PRM (Single-Encounter Elicitation Framework for Diagnostic Excellence Patient-Reported Measures). ResultsWe defined the SEE-Dx-PRM's scope as intended for a single diagnostic encounter in emergency or urgent care, prospective and agnostic of the health condition, and with a timeframe of within several days up to a month from the encounter. The SEE-Dx-PRM's diagnostic excellence outcomes are: (1) accurate diagnosis and (2) either final, or working diagnosis, or specific next steps to establish diagnosis that were communicated and comprehended by patients. SEE-Dx-PRM encompasses 2 domains associated with accurate diagnosis, 5 domains of patient perception of iterative diagnostic process, 5 domains associated with communication and comprehension, and a domain associated with uncertainty. ConclusionSEE-Dx-PRM-informed measures might support quality improvement, prompt system response, and research on diagnostic excellence. InnovationSEE-Dx-PRM presents a novel patient-centered framework for the emerging diagnostic excellence construct and its measurement.

Identifying potential outcomes of patient engagement in primary care quality improvement: a modified Delphi study.

A barrier to dedicating resources towards patient engagement in primary care quality improvement is the lack of clearly identified outcomes that might result from these initiatives. We sought to identify these potential outcomes at three healthcare levels as defined by the Institute of Medicine: 1) Micro/Direct Care; 2) Meso/Microsystem; and 3) Macro/Clinic/System using a Modified Delphi technique. Two focus groups of patients and primary care clinician leaders generated a first set of outcomes. These outcomes were then vetted and expanded through three web-based surveys sent to twelve national experts. Experts indicated the level of agreement with prior elicited outcomes and generated potential new outcomes. Included outcomes achieved at least 80% agreement. The final list of 46 consensus-derived outcomes was categorized across levels. 22 were at the Micro-level, 9 were at the Meso-level, and 15 were at the Macro-level. Our findings suggest outcomes across all health system levels have the potential for progress when patients are engaged in primary care quality improvement initiatives. Future programs should consider validating and measuring these outcomes as part of their interventions.

Symptom bothersomeness and life interference support Rome clinical criteria as clinically relevant indicators of DGBI.

Irritable bowel syndrome (IBS) and functional dyspepsia (FD) are common disorders of gut-brain interaction (DGBI). The Rome IV criteria are the gold standard for research when diagnosing DGBI. However, bothersomeness, or the degree to which symptoms are distressing or disruptive to a person's daily life, is a potential treatment-seeking motivator that is not assessed by the Rome criteria. The Rome Foundation developed and published diagnostic criteria for clinical practice that include bothersomeness. We aimed to evaluate these constructs via patient focus groups to determine what prompts healthcare-seeking as a means to assess its value in the Rome clinical criteria. Adults meeting Rome IV criteria for IBS, FD, or both participated in focus groups in Australia and the United States. Semi-structured interview transcripts were analyzed using Template Thematic Analysis, with three a priori and other a posteriori themes refined iteratively through team discussion and consensus. Participants confirmed the frequency and duration of symptoms was not sufficient to reflect illness experience. Four major themes emerged: (1) Bothersomeness should be included in assessments of IBS and FD; (2) Patients find many DGBI symptoms bothersome; (3) Bothersomeness traverses multiple domains of quality of life; (4) Patients may hesitate to seek medical advice due to past negative experiences. These findings support the value of the Rome Clinical Criteria. They emphasize the importance of expanding assessments of patients with DGBI to include how bothersome they perceive symptoms to be, how much symptoms interfere with their daily life, and what may moderate their decisions to seek treatment.

Basic concepts in preserving holistic well-being in interstitial lung diseases: A MIHRA and G-FoRSS collaborative summary

Background: Interstitial lung diseases (ILD) are a heterogenous group of diseases that involve inflammation and/or fibrosis of the lung parenchyma. ILD can exert significant stress on a person’s extrapulmonary systems, eroding organ and physical function. Thus, ILD can accelerate age-related vulnerabilities that lead to early onset frailty, which makes frailty prevalent in ILD at any age. Frailty confers a three-fold increase of, and predicts, mortality in ILD. Objective: To present a feasible approach to understanding and addressing holistic health in ILD to fortify physical and psychological capacity markedly enhances a person’s tolerance of ILD and aging. Methods: From our previous published work that consisted of serial Medline and PubMed scoping reviews (with search terms such as frailty, interstitial lung disease, ILD, idiopathic pulmonary fibrosis, IPF, systemic sclerosis, sarcoidosis, well-being), patient focus groups, ILD outcome measures deconstruction and linking to the World Health Organization’s International Classification of Disability, and nominal group processes, we iteratively isolated factors that seem to accelerate and, importantly, protect against and reverse frailty. These factors were presented at The Eastern Pulmonary Conference in September 2024 and summarized herein. Results: The result is a collective statement that (a) summarizes health-care system responsibilities in providing sustainable, humane environments for patients and clinicians; (b) advocates for early intervention and shared decision-making from the time of diagnosis to fortify well-being when living with ILD; and (c) offers guidance to fortify physical, mental, and social well-being as well as health literacy and strength of patient voice. Conclusion: Proactive measures to protect against frailty begins at the time of diagnosis. Interventions that are incremental and based on patient priorities and preferences introduce a feasible approach to holistic well-being.

“…I Wish Someone Told Me About That…”: A Qualitative Assessment of the Educational Needs of Patients Undergoing Cystectomy

OBJECTIVESTo utilize patient feedback to identify areas of need for information and ways to improve delivery of education, due to recognition that cystectomy and urinary diversion is a complex operation often overwhelming patients and caregivers. METHODSWe conducted 5 focus groups of bladder cancer patients (separated by gender and diversion type) treated with cystectomy and urinary diversion (n=17). Questions focused on areas of improvement for patient education. Transcripts were analyzed using the Sort and Sift, Think and Shift© method, with insights directing the creation of a flexible codebook. A team of researchers created thematic summaries from individual codes and performed higher level analyses to characterize salient findings. RESULTSPatients described ways to improve the content, timing, and format of education. Most patients expressed a desire to receive a list of common patient experiences pre-operatively. Information they wish they had known beforehand included nuances of new urinary routines, sexual dysfunction, complications such as abdominal adhesions or hernias, and details regarding discharge criteria. Patients had differing opinions on what amount of information should be offered before surgery, but most agreed that options for more details available later were ideal. Preferences on formatting of information varied. Overall, an assortment of formats could allow patients to tailor their process to different learning preferences and individual situations. CONCLUSIONSPatients highlighted key areas for improvement in the breadth, timing, and format of perioperative education. Continued involvement of patients while developing these educational interventions will be pivotal for meeting patient needs and improving outcomes.

Improving Diabetes Equity and Advancing Care (IDEA) to optimize team-based care at a safety-net health system for Black and Latine patients living with diabetes: study protocol for a sequential, multiple assignment, randomized trial

BackgroundDiabetes is the eighth leading cause of death in the USA. Inequities driven by structural racism and systemic oppression have led to racial/ethnic disparities in diabetes prevalence, diagnosis, and treatment. Diabetes-self management training (DSMT), remote glucose monitoring (RGM), and tailored support from a community health worker (CHW) have the potential to improve outcomes. This study will examine the implementation of these interventions in a safety-net healthcare setting.MethodsUsing implementation science and racial equity principles, this study aims to (1) evaluate the appropriateness; (2) measure fidelity; and (3) compare the effectiveness of varying the combination and sequence of three interventions. An exploratory aim will measure sustainability of intervention adherence and uptake. This mixed-methods trial employs a sequential, multiple assignment randomized trial (SMART) design, patient focus group discussions, and staff interviews. Eligible Black/Latine patients will be recruited using patient lists extracted from the electronic medical record system. After a detailed screening process, eligible patients will be invited to attend an in-person enrollment appointment. Informed consent will be obtained and patients will be randomized to either DSMT or RGM. At 6 months, patients will complete two assessments (diabetes empowerment and diabetes-related distress), and HbA1c values will be reviewed. “Responders” will be considered those who have an HbA1c that has improved by at least one percentage point. “Responders” remain in their first assigned study arm. “Nonresponders” will be randomized to either switch study arms or be paired with a CHW. At 6 months participants will complete two assessments again, and their HbA1c will be reviewed. Twelve patient focus groups, two for each intervention paths, will be conducted along with staff interviews.DiscussionThis study is the first, to our knowledge, that seeks to fill critical gaps in our knowledge of optimal sequence and combinations of interventions to support diabetes management among Black and Latine patients receiving care at a safety-net hospital. By achieving the study aims, we will build the evidence for optimizing equitable diabetes management and ultimately reducing racial and ethnic healthcare disparities for patients living in disinvested urban settings.Trial registrationClinicalTrials.gov: NCT06040463. Registered on September 7, 2023.