Patient-centered Outcome Measures Research Articles

Electronic Health Record Serious Illness Conversation Dashboards: An Implementation Case Series

IntroductionDashboards are used to track and visualize quality indicators within health systems to improve clinical performance. Structured serious illness conversation (SIC) documentation templates within electronic health records (EHR) have enabled the development of SIC dashboards for quality improvement. Little is known about the successes and challenges of SIC dashboards. MethodsThis implementation case series describes findings from semi-structured interviews and surveys with nine palliative care leaders in eight health systems that implemented SIC dashboards. Interviews and case information were analyzed to identify themes. ResultsFive themes were identified. First, dashboards focus on process metrics. By creating transparent and efficient access to data on EHR-documented SICs, dashboards facilitated monitoring of the results of clinician training and quality improvement efforts. Second, palliative care leaders used dashboard data on documented SICs to implement clinician practice change strategies (e.g. data feedback; quality incentives), but clinicians had mixed reactions to data. Third, dashboards facilitated leadership investment in SIC efforts and required financial and technical resources to build and maintain. Fourth, while dashboards streamlined data collection for implementation teams, participants noted challenges with data reliability, including inadequate clinician use of structured SIC documentation templates (which most dashboards rely on for measurement). Fifth, needs and tensions arose with integrating patient-centered outcome measures as part of dashboards. ConclusionDashboards can be powerful tools for identifying gaps in SIC and driving interventions for clinician practice change. However, challenges related to clinician adoption of structured templates for SIC documentation and mixed clinician receptivity to data feedback may limit their reliability and use.

Effectiveness of platelet-rich fibrin in third molar extractions: a randomized controlled split-mouth study

ObjectivesTo date, studies have only investigated the use of platelet-rich fibrin (PRF) after removal of third molars from the mandible or maxilla. Removal of the upper and lower third molars is typically combined into one session per side; therefore, this study aimed to investigate influence on PRF.Materials and methodsThis prospective, single-blinded, randomized controlled, clinical trial (split-mouth design) included 25 patients. After third molar removal, the test group’s sockets were treated with solid PRF clots, whereas the control group’s sockets were conventionally treated. The primary outcome was swelling, which was measured digitally and analogously. Secondary outcomes included trismus, pus, hematoma, and clinical attachment loss (CAL) of the second molars on days 1, 3, 7, and 14. Patient-centered outcome measures and the consumption of painkillers and antibiotics were recorded on days 0–7. The t-test for paired samples, Wilcoxon test, and Chi-Square test were used for statistical analyses.ResultsSwelling was significantly lower on day 14 in the test group (p < 0.05). No statistically significant differences were observed in pain, trismus, and CAL. In the test group, the number of painkillers taken and the number of days of intake were significantly lower (p < 0.05).ConclusionsPRF caused a reduction of painkiller consumption and in the days painkillers were needed. PRF significantly considerably reduced swelling after 14 days. Owing to the lack of differences in other parameters, the integration of PRF application into routine wisdom tooth removal is critical.Clinical relevancePRF affects the long-term outcomes of third molar removal by reducing swelling and reducing as well as shortening painkiller consumption.Trial registrationclinicaltrials.gov (NCT05089812).

Use of opioids and opioid alternatives during general anesthesia: a pan-Canadian survey among anesthesiologists.

While there is limited patient-centred evidence (i.e., evidence that is important for patients and end-users) to inform the use of pharmacologic opioid minimization strategies (i.e., the use of opioid alternatives) for adult surgical patients requiring general anesthesia, such strategies are increasingly being adopted into practice. Our objectives were to describe anesthesiologists' beliefs regarding intraoperative opioid minimizing strategies use and utility, and to explore important clinical decision-making factors. We conducted a pan-Canadian web-based survey of anesthesiologists that was distributed using a modified Dillman technique. Our multidisciplinary team, including a patientpartners panel, participated in the process of domains and items generation, items reduction, formatting, and composition. Our sampling frames were members of the Canadian Anesthesiologists' Society and members of the Association des Anesthésiologistes du Québec. We used the newsletters of each organization to distribute our survey, which was available in English and French and housed on the LimeSurvey (LimeSurvey GmbH, Hamburg, Germany) platform. From our eligible sampling frame, 18% completed the survey (356 respondents out of 2,008 eligible participants). Most of the respondents believed that using opioid minimization strategies during general anesthesia could improve postoperative clinical outcomes, including pain control (84% agree or strongly agree, n = 344/409). Reported use of pharmacologic opioid minimization strategies was variable; however, most respondents believed that nonsteroidal anti-inflammatory drugs, acetaminophen, N-methyl-D-aspartate receptor antagonists (ketamine), α2-adrenoceptor agonists (dexmedetomidine), corticosteroids, and intravenous lidocaine improve prostoperative clinical outcomes. The primary factors guiding decision-making regarding the use of opioid minimization strategies were postoperative acute pain intensity, the impact of acute pain on functioning, patient well-being (i.e., quality of recovery) and patient satisfaction with care. A lack of evidence was the most important barrier limiting the use of opioid minimization strategies. In our survey of Canadian anesthesiologists, several opioid minimization strategies were believed to be effective complements to general anesthesia, although there was substantial variation in their reported use. Future randomized controlled trials and systematic reviews evaluating the effectiveness of opioid minimization strategies should prioritize patient-centred outcome measures assessment such as the quality of recovery or the impact ofacute pain on functioning.

Days at Home After Traumatic Brain Injury: Moving Beyond Mortality to Evaluate Patient-Centered Outcomes Using Population Health Data.

Administrative data are invaluable for assessing outcomes at the population level. However, there are few validated patient-centered outcome measures that capture morbidity following traumatic brain injury (TBI) using these data. We sought to characterize and validate days at home (DAH) as a measure to quantify population-level outcomes after moderate to severe TBI. We additionally assessed the earliest feasible outcome assessment period for patients with TBI using this outcome measure. This multicenter retrospective cohort study used linked health administrative data sources to identify adults with moderate to severe TBI presenting to trauma centers in Ontario, Canada, between 2009 and 2021. DAH at 180 days (DAH180 days) reflects the total number of days spent alive and at home excluding the days spent institutionalized across care settings. Construct validity was determined using hierarchical quantile regression to assess the associations between clinical and injury covariates with DAH180 days. Predictive validity was assessed using Spearman rank correlation. We estimated minimally important difference (MID) in DAH180 days to aid with outcome measure interpretability. There were 6,340 patients who met inclusion criteria. Median DAH180 days was 70 days (interquartile range 0-144). Mortality occurred in 2,162 (34.1%) patients within 90 days following injury. Patients in the lower DAH180 days group were more commonly older (absolute standardized difference [ASD] = 0.68) with higher preinjury health resource utilization (ASD = 0.36) and greater injury severity (ASD = 0.81). Increased baseline health resource utilization (-10.1 days, 95% CI -17.4 to -2.8, p = 0.0041), older age (-4.6 days, 95% CI -5.7 to -3.4, p < 0.001), higher cranial injury severity (-84.6 days, 95% CI -98.3 to -71.0, p < 0.001), and major extracranial injuries (-14.2 days, 95% CI -19.5 to -8.93, p < 0.001) were significantly associated with fewer DAH180 days. DAH180 days was positively correlated with DAH at up to 3 years (r = 0.91, 95% CI 0.90-0.92) and negatively correlated with direct health care expenditure (rs = -0.89, 95% CI -0.88 to -0.90). The average MID estimated from anchor-based and distribution-based methods was 18 days. We validate DAH180 days as a potentially useful outcome measure with construct, predictive, and face validity in a population with moderate to severe TBI. Given the intensity of acute care requirements for patients with TBI, our work highlights DAH180 days as a feasible and sufficiently responsive outcome measure.

Developing Standard Sets of Indicators for Patient-Centered Outcome Measures

The article describes how working groups of medical specialists led by the International Consortium for Health Outcomes Measurement (ICHOM) develop standard sets of indicators for patient-centered outcome measures. The main stages of working groups’ activity, methods, and criteria for including indicators were defined. The study showed that outcomes are comparable across countries since standard sets of indicators can be used by healthcare organizations all over the world, regardless of the healthcare model. While it is confirmed that the data obtained using PROM questionnaires are valid and reliable, it is recommended, based on the literature review, to fine-tune the standard sets of indicators for some nosologies to the features of the local healthcare system.

Meaningful patient and public engagement in dissemination-embedding co-production in dementia research.

Patient and Public Involvement and Engagement (PPIE) is still underutilised in both dementia research and corresponding dissemination activities. To describe the methods, format, and lessons learned in co-creating and co-producing a dissemination strategy for a research project focused on establishing patient-centred outcome measures into routine palliative community care for persons living with dementia (PLWD) and their informal carers. A participatory, hybrid-format workshop was conducted to co-create the dissemination strategy with a PPIE group. A video presentation of findings and a list of prompts shared prior to the workshop were used to elicit views on dissemination strategies and knowledge translation. The workshop was followed up with a survey to consolidate the dissemination strategy. Workshop minutes and survey responses were analysed using qualitative thematic analysis. 22 participants from our diverse PPIE group attended the workshop. Two major themes emerged: (a) Knowledge translation: building bridges between research and practise, and (b) Collaboration and dissemination: everyone's voice is needed. Participants suggested critical changes to dissemination methods and materials. Successful knowledge translation depends on a strong evidence base. For this, materials need to be tailored to specific audiences. Everyone's voice needs to be integrated through co-production in dissemination activities by PPIE members to influence societal change. Tailored dissemination activities within a dissemination strategy were co-created spanning all phases of the research cycle. Informing and educating the public and policymakers about the needs of PLWD relies on disseminating and fostering knowledge translation throughout all phases of the research cycle.

Conceptual review of outcome metrics and measures used in clinical evaluation of artificial intelligence in radiology.

Artificial intelligence (AI) has numerous applications in radiology. Clinical research studies to evaluate the AI models are also diverse. Consequently, diverse outcome metrics and measures are employed in the clinical evaluation of AI, presenting a challenge for clinical radiologists. This review aims to provide conceptually intuitive explanations of the outcome metrics and measures that are most frequently used in clinical research, specifically tailored for clinicians. While we briefly discuss performance metrics for AI models in binary classification, detection, or segmentation tasks, our primary focus is on less frequently addressed topics in published literature. These include metrics and measures for evaluating multiclass classification; those for evaluating generative AI models, such as models used in image generation or modification and large language models; and outcome measures beyond performance metrics, including patient-centered outcome measures. Our explanations aim to guide clinicians in the appropriate use of these metrics and measures.

Effect of the T3 analogue triac on patient-centered outcome measures in patients with MCT8 deficiency: post-hoc analysis of the international triac trial I

Effect of the T3 analogue triac on patient-centered outcome measures in patients with MCT8 deficiency: post-hoc analysis of the international triac trial I

Clinically mild hidradenitis suppurativa: mild for whom?

Severe levels of illness, measured through Patient Reported Outcomes, are frequent among Hidradenitis Suppurativa patients classified as having mild disease according to the International Hidradenitis Suppurativa Score System. The systematic use in clinical practice of patient-centered outcome measures, capable of accurately detecting and portraying the true severity of the impact of skin conditions, may help improve patient care.

Measuring perceived utility of genomic sequencing: Development and validation of the GENEtic Utility (GENE-U) scale for adult screening

PurposeAs population-based screening programs to identify genetic conditions in adults using genomic sequencing (GS) are increasingly available, validated patient-centered outcome measures are needed to understand participants’ experience. We aimed to develop and validate an instrument to assess the perceived utility of GS in the context of adult screening. MethodsInformed by a 5-domain conceptual model, we used a 5-step approach to instrument development and validation: (1) item writing, (2) cognitive testing, (3) pilot testing and item reduction, (4) psychometric testing, and (5) evaluation of construct validity. Adults undergoing risk-based or population-based GS who had received GS results as part of ongoing research studies participated in structured cognitive interviews and 2 rounds of surveys. After item pool refinement, we conducted an exploratory factor analysis and calculated Pearson correlations with related instruments. ResultsWe derived the 18-item Adult Screening version of the GENEtic Utility scale (total sum score α = .87). Mirroring the Pediatric Diagnostic version, the instrument has a 2-factor structure, including an Informational Utility subscale (14 items, α = .89) and an Emotional Utility subscale (4 items, α = .75). The Informational Utility subscale was strongly associated with empowerment and personal utility of GS. Correlations of the Emotional Utility subscale with psychosocial impact and anxiety and depression were weak to moderate. ConclusionInitial psychometric testing of the Adult Screening GENEtic Utility scale demonstrates its promise, and additional validation in translational genomics research is warranted.

A case study on the implementation of quality and comprehensive indicators set in routine diabetes care

IntroductionType 2 diabetes is a major public health issue in Mexico due to its high prevalence and its projection for the coming years for this disease. Findings on multidisciplinary care related to chronic diseases have proven effective, based on measurement of patient-centered outcomes, The Center of Comprehensive Care for Patients with Diabetes (CAIPaDi) is a multidisciplinary program focused on reducing diabetes complications. This case study aims to illustrate the results of implementing health outcomes measurements and demonstrate the beneficial effects of establishing a comprehensive model of care through a patient-centered approach.MethodsA descriptive analysis of the comprehensive care indicators of patients with type 2 diabetes treated in the CAIPaDi program between 2013 and 2023 was conducted. The results were structured according to the standard set of outcomes for diabetes proposed by the International Consortium for Health Outcomes Measurements (ICHOM).ResultsThe baseline and prospective registration of consultations was completed for five years, complying with 25 of the 26 indicators of the ICHOM set. In diabetes control, 56.5% of patients had A1c ≤ 7%, 87.9% had BP ≤ 130/80 mmHg, 60.9% had LDL-cholesterol < 100 mg/dl, and obesity rates decreased from 42.19% to 30.6% during annual consultations. Fewer years of diagnosis before the first visit is key to overall improvement in program adherence (P = 0.02).In acute events, a hyperglycemic crisis occurred in only two cases and severe hypoglycemia episodes in 8 patients. For chronic complications, no lower limb amputations occurred. Cardiovascular outcomes occurred in < 1%. Periodontal disease was analyzed, and periodontitis decreased from 82.9% to 78.7%. Mortality reports were low, with COVID-19 being the main cause of death. Patient-reported outcomes demonstrated reductions in anxiety, depression, and diabetes distress during follow-up.ConclusionRegistering quality-of-care indicators is feasible in a comprehensive care program. It allows improving the medical, mental health, and lifestyle outcomes of patients with type 2 diabetes and provides relevant data for planning health programs. A quick diagnosis before program adherence is crucial for overall improvement in patients.

Review of the Longitudinal Management of Autoimmune Encephalitis, Potential Biomarkers, and Novel Therapeutics.

Increasing awareness and earlier diagnosis of autoimmune encephalitis (AE) have led to a greater number of patients being cared for longitudinally by neurologists. Although many neurologists are now familiar with the general approach to diagnosis and acute immunosuppression, this review aims to provide neurologists with guidance related to management beyond the acute phase of disease, including long-term immunosuppression, monitoring, potential biomarkers of disease activity, outcome measures, and symptom management. Observational studies in AE have demonstrated that early diagnosis and treatment is associated with improved neurologic outcomes, particularly in AE with antibodies targeting neuronal cell surface/synaptic proteins. The literature regarding long-term management is evolving. In addition to traditional immunosuppressive approaches, there is emerging use of novel immunosuppressive therapies (ISTs) in case series, and several randomized controlled trials are planned. Novel biomarkers of disease activity and methods to measure outcomes and response to treatment are being explored. Furthermore, it is increasingly recognized that many individuals have chronic symptoms affecting quality of life including seizures, cognitive impairment, fatigue, sleep disorders, and mood disorders, and there are emerging data supporting the use of patient centered outcome measures and multidisciplinary symptom-based care. This review aims to summarize recent literature and offer a practical approach to long-term management of adult patients with AE through a multidisciplinary approach. We summarize current knowledge on ISTs, potential biomarkers of disease activity, outcome measures, and long-term sequelae. Further research is needed to answer questions regarding optimal IST, biomarker validity, and sequelae of disease.

Development of a standardized set of outcomes for autism spectrum disorder: The International Consortium for Health Outcomes Measurement (ICHOM)

BackgroundAutism spectrum disorder (ASD) is characterized by persistent deficits in reciprocal social interaction, communication, and restricted, repetitive, behaviour, that are atypical or excessive for the individual’s age and sociocultural context (Diagnostic and Statistical Manual 5th ed TR.; 2022). The rate of ASD continues to increase and remains a concern due to inequitable access to diagnosis and quality services. A lack of standardization in assessment and treatment presents further difficulty in benchmarking and improving care. MethodThe International Consortium for Health Outcomes Measurement (ICHOM) recruited a Working Group (WG) of 20 subject matter experts, including researchers, clinicians, policy makers, and lived-experience experts to identify a minimum set of measurable outcomes along with case mix variables (i.e., risk adjustment factors). A proposed set of Patient Centered Outcome Measures (henceforth known as the ASD Set) was identified and endorsed using a modified Delphi process to reach consensus. ResultsThe WG took into consideration variation in global health, social care and educational systems were considered to ensure implementation of the ASD Set is feasible. The Set includes a core set of measurable outcomes (i.e., domains) that include core symptoms, daily functioning, accessibility, and support. ConclusionsThe ICHOM ASD Set is a scientifically-sound, internationally vetted tool that will enable assessment of care for individuals with ASD that can facilitate targeted, person-centered clinical and social inclusion strategies. Large scale implementation and use should generate standardized data describing the individual's health and wellbeing that can inform decision-making, quality improvement and best-practices insights.

Report of the IDEOM Meeting Adjacent to the GRAPPA 2023 Annual Meeting.

The nonprofit organization International Dermatology Outcome Measures (IDEOM) is committed to improving the implementation of patient-centered outcome measures in dermatologic disease. At a conference adjacent to the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2023 annual meeting, the IDEOM Psoriatic Disease Workgroup presented updates on recent efforts in outcome measure advancement. Dr. Alice Gottlieb presented the preliminary findings of a study within the Mount Sinai Health System that aims to determine how well the IDEOM musculoskeletal (MSK) symptom framework, which uses the Psoriasis Epidemiology Screening Tool (PEST) and the Psoriatic Arthritis Impact of Disease (PsAID) instruments, functions in clinical settings. Drs. Joseph Merola and Lourdes Perez-Chada updated attendees on the IDEOM MSK-Q, a 9-item patient-reported questionnaire designed to measure the intensity and impact of MSK symptoms on the quality of life in patients with psoriasis (PsO) with or without psoriatic arthritis (PsA). Dr. Vibeke Strand summarized the Outcome Measures in Rheumatology (OMERACT) 2023 conference sessions. Dr. April Armstrong discussed the preliminary findings of a multicentered study designed to validate the 7-item Dermatology Treatment Satisfaction Instrument (DermSat-7) among patients with PsO. She also introduced the Psoriasis and Psoriatic Arthritis Treatment Satisfaction Instrument, a tool that seeks to capture the level of patient satisfaction with current therapy for PsO and PsA. This report summarizes the developments discussed at the IDEOM PsO and PsA research workgroups during the GRAPPA 2023 annual meeting.

A patient-centered textbook outcome measure effectively discriminates contemporary elective open abdominal aortic aneurysm repair quality

BackgroundThere is persistent controversy surrounding the merit of surgical volume benchmarks being used solely as a sufficient proxy for assessing the quality of open abdominal aortic aneurysm (AAA) repair. Importantly, operative volume quotas may fail to reflect a more nuanced and comprehensive depiction of surgical outcomes most relevant to patients. Accordingly, we herein propose a patient-centered textbook outcome (TO) for AAA repair that is analogous to other large magnitude extirpative operations performed in other surgical specialties, and test its feasibility to discriminate hospital performance using Society for Vascular Surgery (SVS) volume guidelines. MethodsAll elective open infrarenal AAA repairs (OAR) in the SVS-Vascular Quality Initiative were examined (2009-2022). The primary end point was a TO, defined as a composite of no in-hospital complication or reintervention/reoperation, length of stay of ≤10 days, home discharge, and 1-year survival rates. The discriminatory ability of the TO measure was assessed by comparing centers that did or did not meet the SVS annual OAR volume threshold recommendation (high volume ≥10 OARs/year; low volume <10 OARs/year). Logistic regression and multivariable models adjusted for patient and procedure-related differences. ResultsA total of 9657 OARs across 198 centers were analyzed (mean age, 69.5 ± 8.4 years; female, 26%; non-White, 12%). A TO was identified in 44% (n = 4293) of the overall cohort. The incidence of individual TO components included no in-hospital complication (61%), no in-hospital reintervention or reoperation (92%), length of stay of ≤10 days (78%), home discharge (76%), and 1-year survival (91%). Median annual center volume was 6 (interquartile range, 3-10) and a majority of centers did not meet the SVS volume suggested threshold (<10 OARs/year, n = 148 [74%]). However, most patients (6265 of 9657 [65%]) underwent OAR in high-volume hospitals. When comparing high- and low-volume centers, a TO was more likely to occur in high-volume institutions: ≥10 OARs/year (46%) vs <10 OARs/year (42%; P = .0006). The association of a protective effect for higher center volume remained after risk adjustment (odds ratio, 1.1; 95% confidence interval, 1.05-1.26; P = .003). ConclusionsTOs for elective OAR reflect a more nuanced and comprehensive patient centered proxy to measure care delivery, consistent with other surgical specialties. Surprisingly, a TO was achieved in <50% of elective AAA cases nationally. Although the likelihood of a TO seems to correlate with SVS center volume recommendations, it more importantly reflects elements which may be prioritized by patients and thus offers insights into further improving real-world AAA care.

Friedreich Ataxia Caregiver-Reported Health Index: Development of a Novel, Disease-Specific Caregiver-Reported Outcome Measure.

The Friedreich ataxia (FRDA) scientific community needs access to patient-centered outcome measures that satisfy regulatory guidelines and are capable of tracking clinically meaningful changes in FRDA disease burden. The objective of this research was to develop a novel, disease-specific caregiver-reported outcome measure for use in FRDA research and clinical care. In prior work, we conducted qualitative interviews and a cross-sectional study of FRDA caregivers and patients to determine the symptoms of greatest importance to individuals with FRDA. We designed the Friedreich Ataxia Caregiver-Reported Health Index (FACR-HI) to serially measure the symptoms of greatest importance to patients and utilized factor analysis, beta testing, reliability testing, and cross-sectional subgroup analysis to further evaluate and optimize this disease-specific outcome measure. The FACR-HI was designed to measure total disease burden and disease burden in 18 symptomatic domains. The FACR-HI total score demonstrated high internal consistency (Cronbach's α = 0.98) and test-retest reliability (intraclass correlation coefficient = 0.96). Beta interview participants found the FACR-HI to be highly relevant, comprehensive, and easy to use. FACR-HI total and subscale scores were associated with functional staging for ataxia scores and speech impairment. Initial evaluation of the FACR-HI supports its content validity, test-retest reliability, and construct validity as a caregiver-reported outcome measure for assessing how pediatric individuals with FRDA feel and function. The FACR-HI provides a potential mechanism to quantify changes in multifactorial FRDA disease burden during future clinical trials.

P.116 Days at home after traumatic brain injury: moving beyond mortality to evaluate patient-centered outcomes using population health data

Background: Despite the utility of administrative health data, there remains a lack of patient-centered outcome measures to meaningfully capture morbidity after traumatic brain injury (TBI). We sought to characterize and validate days at home (DAH) as a feasible measure to assess population-level moderate to severe TBI (msTBI) outcomes and health resource utilization. Methods: We utilized linked health administrative data sources to identify adults with msTBI patients presenting to trauma centers in Ontario injured between 2009-2021. DAH at 180 days reflects the total number of days spent alive and at home excluding the days spent institutionalized in acute care, rehabilitation, inpatient mental health settings or post-acute readmissions. Construct and predictive validity were determined; we additionally estimated minimally important difference (MID) in DAH180days. Results: There were 6340 patients that met inclusion criteria. Median DAH180days were 70 days (interquartile range 0-144). Increased health resource utilization at baseline, older age, increasing cranial injury severity and major extracranial injuries were significantly associated with fewer DAH180days. DAH180days was correlated to DAH counts at 1-3 years. The average MID estimate from anchor-based and distribution-based methods was 18 days. Conclusions: We introduce DAH180days as a feasible and sufficiently responsive patient-centered outcome measure with construct, predictive and face validity in an msTBI population.

#2535 Development of a patient-centered outcome strategy for the CONVINCE trial

Abstract Background and Aims Patient-centered outcomes play an important role when assessing treatment effects. Patient-reported outcome (PRO) measures assessing symptoms and impacts are important tools to capture the patient perspective in clinical trials. However, careful consideration is needed when choosing PROs and PRO measures. Aspects such as the conceptual model, measurement model, validity, reliability, and responsiveness, as well as translation, interpretability of scores and burden for participants and investigators have to be considered when developing a patient-centered outcome strategy. The CONVINCE randomized controlled trial was funded by the European Union (HORIZON2020) to assess effects of high-dose hemodiafiltration (HDF) versus high-flux hemodialysis (HD). The primary outcome is all-cause mortality and one of the secondary outcomes is the experienced health status of the patients as measured by patient-reported outcomes. The aim of this study is to describe the approach for the development of a patient-centered outcome strategy using a domain-based approach that was implemented in the CONVINCE trial. Method The development of the patient-centered outcome strategy for the CONVINCE trial followed three consecutive steps: (1) targeted literature review to identify core outcome sets, as well as concepts and PRO measures in the field of dialysis; (2) semi-structured interviews and focus groups with dialysis patients (n = 13) and clinicians (n = 4) to determine health aspects, i.e. symptoms and impacts most relevant to patient population; (3) triangulation of results to determine the most relevant health domains to assess within the context of the CONVINCE trial and determination of PRO measures in due consideration of psychometric properties of respective instruments. Results We identified 97 PRO measures reported in previous dialysis studies, assessing more than 11 health domains and 41 disease-specific symptoms/problems relevant for dialysis patients. Core outcome sets, such as the SONG-HD and the ICHOM standard set for chronic kidney disease, indicated in total 19 outcomes that we classified as potential PROs. Interviews with patients and clinicians confirmed health domains and outcomes that were identified in the literature and provided further insights in terms of the level of importance of health domains. To balance the comprehensiveness of assessments and respondent burden, we decided to concentrate on 9 domains and 20 symptoms/problems according to the objectives of the trial. For the more proximal outcomes, i.e. recovery time and recovery time pattern, new items were developed by the CONVINCE consortium applying established state-of-the-art methods. For generic outcomes, e.g. fatigue, physical function, we decided to apply psychometrically advanced tools from the PROMIS® initiative, validated within a general population as well as various chronic health conditions. Conclusion Building upon core outcome sets by confirming health concepts most relevant for dialysis patients within the specific context of the CONVINCE trial, enabled us to develop a robust patient-centered outcome measurement strategy for the CONVINCE trial that assesses relevant health domains of dialyses patients in granular fashion using a domain-based approach. Further validation of the PRO measures should be considered, especially establishing meaningful change estimates to support interpretation of change in PRO measurement scores. Conference Abstract ERA EDTA; May 23-26, 2024; Stockholm, Sweden Kathrin I. Fischer, Peter J. Blankestijn, Krister Cromm, Michiel L. Bots, Claudia Barth, Bernard Canaud, Jörgen Hegbrant, Giovanni Strippoli, Andrew Davenport, Mark Woodward, Matthias Rose for the CONVINCE Scientific Committee and CONVINCE Investigators

An International, Multidisciplinary Consensus Set of Patient-Centered Outcome Measures for Substance-Related and Addictive Disorders.

Background: In 1990, the United States' Institute of Medicine promoted the principles of outcomes monitoring in the alcohol and other drugs treatment field to improve the evidence synthesis and quality of research. While various national outcome measures have been developed and employed, no global consensus on standard measurement has been agreed for addiction. It is thus timely to build an international consensus. Convened by the International Consortium for Health Outcomes Measurement (ICHOM), an international, multi-disciplinary working group reviewed the existing literature and reached consensus for a globally applicable minimum set of outcome measures for people who seek treatment for addiction. Methods: To this end, 26 addiction experts from 11 countries and 5 continents, including people with lived experience (n = 5; 19%), convened over 16 months (December 2018-March 2020) to develop recommendations for a minimum set of outcome measures. A structured, consensus-building, modified Delphi process was employed. Evidence-based proposals for the minimum set of measures were generated and discussed across eight videoconferences and in a subsequent structured online consultation. The resulting set was reviewed by 123 professionals and 34 people with lived experience internationally. Results: The final consensus-based recommendation includes alcohol, substance, and tobacco use disorders, as well as gambling and gaming disorders in people aged 12 years and older. Recommended outcome domains are frequency and quantity of addictive disorders, symptom burden, health-related quality of life, global functioning, psychosocial functioning, and overall physical and mental health and wellbeing. Standard case-mix (moderator) variables and measurement time points are also recommended. Conclusions: Use of consistent and meaningful outcome measurement facilitates carer-patient relations, shared decision-making, service improvement, benchmarking, and evidence synthesis for the evaluation of addiction treatment services and the dissemination of best practices. The consensus set of recommended outcomes is freely available for adoption in healthcare settings globally.

Early Quality of Recovery after Elective Cardiothoracic and Aortic Surgeries in Adult Patients: A Pilot Report.

Patient-centered outcome measures should be evaluated postoperatively as the recovery after surgery varies between patients. We aimed to evaluate the feasibility, reliability, and trajectory of the quality of recovery-15 (QoR-15) in patients undergoing cardiothoracic and aortic surgeries. This retrospective study included adult patients who underwent elective cardiothoracic and aortic surgeries. The primary outcome was the QoR-15, with a minimal clinically important difference of 6.8, assessed on postoperative days (POD) 2, 4, and 7. The final analysis included patients with at least one valid outcome. Feasibility and reliability were assessed by the successful completion rate on each POD and using Cronbach's alpha of the QoR-15 on POD 4. A linear mixed model was used to evaluate the trajectory of the postoperative QoR-15 scores. Of the 36 eligible patients, 30 with a mean age of 70 years were included in the final analysis. The successful completion rates on POD 2, 4, and 7 were 72.7%, 87.8%, and 87.8%, respectively. The mean QoR-15 scores on POD 2, 4, and 7 were 89.9, 98.0, and 108.3, respectively. The QoR-15 scores on POD 2 and 4 were not statistically different (P = 0.06) but were clinically significant. The QoR-15 score on POD 7 was statically (P < 0.001) and clinically higher than the QoR-15 score on POD 2. Cronbach's alpha for the QoR-15 score measured on POD 4 was 0.85. The QoR-15 is a feasible and valid measurement after elective cardiothoracic surgery, which increases significantly over time after surgery.