Patient-centered Outcomes Research Articles

Developing an Integrated Longitudinal Dataset for Patient-Centered Outcome Measures in Cost-Related Medication Nonadherence.

Cost-related medication nonadherence (CRN) is an important patient-centered outcome measure. Longitudinal follow-up of CRN is rare. We propose to develop a novel integrated dataset to study CRN longitudinally. A dataset of 2000 Medicare beneficiaries at high risk of hospitalization surveyed quarterly on CRN and followed up individually for 8 quarters between 2013 and 2018 was linked to Medicare files. A metric of CRN categorizing persistent, intermittent, and transient CRN during the 8 quarters was developed. An ordered logit model and a logit model were developed to assess the factors influencing CRN overall and persistent CRN, respectively. A total of 1761 patients were included in the analysis, among whom 869 (49.3%) reported CRN at least once in the 8-quarter study period, 178 (10%) reported persistent CRN, 395 (22.4%) reported intermittent CRN, and 296 (16.8%) reported transient CRN. The conditional effect in the logit model for persistent CRN revealed that baseline dual eligibility was negatively associated (adjusted odds ratio = 0.45, P < 0.01) and depression positively associated (adjusted odds ratio = 1.55, P = 0.01) with persistent CRN. The marginal analysis in the ordered logit model revealed a clear pattern of higher probabilities of persistent and intermittent CRN at younger ages while transient CRN was flat. Among the 252 subjects who were deceased, 31 (12.3%) reported persistent CRN, compared with 147 (9.74%) who were alive (P = 0.21 by χ2 test). A significant number of patients reported persistent CRN, including those who were at the end of life. Research is critically needed to understand behavioral patterns among the younger Medicare population.

Medicare Data Linkages for Conducting Patient-Centered Outcomes Research on Economic Outcomes.

Medicare patients and other stakeholders often make health care decisions that have economic consequences. Research on economic variables that patients have identified as important is referred to as patient-centered outcomes research (PCOR) and can generate evidence that informs decision-making. Medicare fee-for-service (FFS) claims are widely used for research and are a potentially valuable resource for studying some economic variables, particularly when linked to other datasets. The aim of this study was to identify and assess the characteristics of federally funded administrative and survey data sources that can be linked to Medicare claims for conducting PCOR on some economic outcomes. A targeted internet search was conducted to identify a list of relevant data sources. A technical panel and key informant interviews were used for guidance and feedback. We identified 12 survey and 6 administrative sources of linked data for Medicare FFS beneficiaries. A majority provide longitudinal data and are updated annually. All linked sources provide some data on social determinants of health and health equity-related factors. Fifteen sources capture direct medical costs (beyond Medicare FFS payments); 5 capture indirect costs (eg, lost wages from absenteeism), and 7 capture direct nonmedical costs (eg, transportation). Linking Medicare FFS claims data to other federally funded data sources can facilitate research on some economic outcomes for PCOR. However, few sources capture direct nonmedical or indirect costs. Expanding linkages to include additional data sources, and reducing barriers to existing data sources, remain important objectives for increasing high-quality, patient-centered economic research.

Economic Outcomes in Patient-Centered Outcomes Research: A Paradigm Shift.

Economic Outcomes in Patient-Centered Outcomes Research: A Paradigm Shift.

Commentary: Determining Economic Factors That Matter to People With Intellectual and Developmental Disabilities and Their Caregivers: A Process Framework.

The 2020-2029 strategic plan for the Patient-Centered Outcomes Research Trust Fund calls for addressing data infrastructure gaps that are critical for studying issues around intellectual and developmental disabilities (I/DD). Specifically, the plan calls for data collection on economic factors that affect person-centered approaches to health care decision-making. Among people with I/DD and their caregivers, such economic factors may include financial costs of care, decreased opportunities for leisure and recreation, income losses associated with caregiving, and foregone opportunities for skill acquisition or other human capital investments. This commentary supports responsiveness to the Patient-Centered OutcomesResearch Trust Fund (PCORTF) calls by conceptualizing and operationalizing a framework for identifying preferences on economic factors that are relevant to people with I/DD and their caregivers. The framework outlined in this commentary addresses barriers to data collection that hinder measure development in the study of I/DD. This work is significant and timely given the continued movement to integrate and maintain people with I/DD within communities and recent methodological advances for eliciting preferences among people with I/DD. Readers will be introduced to a framework for building data capacity in the study of economic outcomes among a population that is a high research priority for federal funding agencies. This commentary aims to be useful to researchers in planning, developing, and initiating projects in this area.

Abstract 13238: Persistence of High Rates of Major Adverse Cardiovascular Events at 1 Year Post-Myocardial Infarction in Patients With Multivessel Disease: A Systematic Literature Review

Background: Multivessel disease (MVD) heightens the risk of major adverse cardiovascular events (MACE) in post-myocardial infarction (MI) patients. The risk of MACE is elevated in the early period after an MI, a period unaddressed by current secondary preventative therapies. Research aims: To better understand the impact of MVD on clinical and patient-centered outcomes post-MI in the current treatment landscape. Methods: A systematic literature review was conducted to identify relevant articles published between March 2019 and July 2022 from MEDLINE, Embase, Cochrane databases, and cardiovascular (CV) and health outcomes conferences. Articles reporting on pre-specified clinical or patient-centered outcomes in post-MI patients with MVD at timepoints within 1 year were included. Studies that included patients with cardiogenic shock were excluded from this review. Results: Clinical and patient-centered outcomes were reported in five randomized-controlled trials (RCTs) and 24 observational studies across 30 articles; and one RCT across two articles, respectively. Although the definition of MVD varied, it was generally characterized by ≥50% stenosis in ≥1 noninfarct-related coronary artery. Rates of individual MACE endpoints (all-cause mortality, CV mortality, MI, stroke) were variable (Table), likely due to heterogeneity in study populations and interventions. Nevertheless, a key trend was identified; MACE rates at 1-year post-MI were typically not substantially higher than those at earlier timepoints. EQ-5D scores, reflective of quality of life (QoL), increased following treatment; however, increases were marginal, indicating minimal improvements in QoL. Conclusions: MVD is associated with high rates of MACE early after MI that persist at 1 year. Novel therapies that address CV risk in the early period post-MI may support improved CV outcomes among patients with MVD. Further data on patient-centered outcomes are warranted.

Abstract 13362: Proteomic Architecture of Frailty Across the Spectrum of Cardiovascular Disease

Introduction: With an aging population, understanding how frailty affects treatment response is paramount to improve patient-centered outcomes. Hypothesis: We hypothesized that circulating proteomic correlates of frailty will identify novel pathways for therapeutic investigation and provide prognostic information. Methods: From a multicenter, prospective cohort of 809 participants (median age 83 years; 44% women) with symptomatic, severe aortic stenosis (AS) and systematic assessments of frailty, we measured &gt;900 circulating proteins (Olink). We used principal component analysis (PCA) to define composite “axes” of 12 measures of frailty (Figure). Using ordinary and penalized regression (LASSO), we related proteins to both individual measures of frailty and the composite axes. Prioritized proteins were then examined for their relation with age and morbidity in external, published datasets. LASSO model coefficients were used to calculate protein “scores” of frailty, which were tested for their relation with all-cause mortality in the AS cohort and cause specific mortality in &gt;1,800 participants from the Framingham Heart Study (FHS; mean age 55 years, 54% women). Results: PCA identified 3 axes of frailty (“patient reported outcomes”, “body composition” and “physical function”) that explained ≈49% of variance. Proteins related to axes of frailty were (1) related to inflammatory and metabolic phenotypes and (2) weakly related to age, in &gt;35,000 community dwelling Icelanders (mean age 55±17 years). The protein score of physical function was associated with all-cause post-transcatheter aortic valve implantation (TAVI) mortality in the AS cohort (HR 0.68 [0.59-0.79]) and non-cardiovascular mortality in FHS (0.83 [0.75-0.91]). Conclusions: Circulating proteins capture frailty phenotypes that are weakly related to age, and provide prognostic information in both older adults undergoing TAVI and younger community dwelling adults.

Nutritional support and prevention of post-intensive care syndrome: the Italian SIAARTI survey

BackgroundMalnutrition and muscle wasting are common in ICU patients and predict adverse patient-centered outcomes. The Italian Society of Anesthesia Analgesia Resuscitation and Intensive Care (SIAARTI) conducted a nationwide survey to identify the nutritional practices in the Italian ICUs and to plan future, training interventions to improve the national clinical practice.MethodsNationwide online survey, involving Italian ICUs, developed by experts affiliated with SIAARTI. Invitations to participate were distributed through emails and social networks. Data were collected over a period of three months (October 1 to December 31, 2022) during 2022.ResultsOne hundred full responses from participating ICUs were collected. The number of beds is < 10 in most ICUs and > 20 in 11 ICUs. Most ICUs (87%) are mixed, cardiac (5%), neurosurgical (4%), or pediatric ICUs (1%). Although the nutritional program is widely prescribed based on the patients’ general evaluation, 52 ICUs (52%) do not perform nutritional risk evaluation at admission in case of > 24-h stay. Daily caloric intake is mainly based on the 25 kcal/kg equation; otherwise, the Harris-Benedict formula is mostly used, whereas indirect calorimetry is less used. Most clinicians apply a personalized nutritional approach to organ failure. Most ICUs have a nutritional management protocol, and enteral nutrition (EN) is frequently started within 2 days from admission, while supplemental parenteral nutrition is used when EN is insufficient by most clinicians. The EN administered seems to correspond to that prescribed, but it is stopped if the gastric residual gastric is > 300–500 ml in most ICUs.ConclusionPrescription, route, and mode of administration of nutritional support seem to be in line with international recommendations, while suggestions on the tools for assessing the nutritional risk and monitoring efficacy and complications seem far less followed. Future national clinical studies are necessary to investigate the optimal nutritional and metabolic management of critically ill patients and the correspondence with the results of this survey on actual practices.

GLOSSARY FOR DENTAL PATIENT-CENTERED OUTCOMES

Dental patient-centered outcomes can improve the relevance of clinical study results to dental patients and generate evidence to optimize health outcomes for dental patients. Dental patient-reported outcomes (dPROs) are of great importance to patient-centered dental care. They can be used to evaluate the health outcomes of an individual patient about the impact of oral diseases and treatment, and to assess the quality of oral health care delivery for a health care entity. dPROs are measured with dental patient-reported outcome measures (dPROMs). dPROMs should be validated and tested before wider dissemination and application to ensure that they can accurately capture the intended dPROs. Evidence suggests inadequate dPRO usage among dental trials, as well as potential flaws in some existing dPROMs. This Glossary presents a collection of main terms in dental patient-centered outcomes to help clinicians and researchers read and understand patient-centered clinical studies in dentistry.

“to Represent a Black Point of View”: Willingness of Black Persons with Multiple Myeloma to Participate in Clinical Trials

Background Cancer clinical trials are essential for advancing scientific knowledge and improving patient-centered clinical outcomes, but racial-ethnic diversity is often lacking (Ajewole et al., 2021; Alqazaqi et al., 2022). In multiple myeloma (MM) trials leading to Food and Drug Administration (FDA) approvals, only about 4% of participants are African American (AA)/Black (Kanapuru et al., 2022) despite higher incidence rates in this group. Barriers, like medical mistrust, communication issues, trial location, and eligibility criteria, contribute to underrepresentation (Grant, Jansen, et al., 2022; Grant, Jean-Baptiste, et al., 2022b; a; Kanapuru et al., 2023). Understanding factors influencing participation is critical for recruitment (Sheridan et al., 2020), yet a focus on the willingness of Black persons to participate in clinical trials remains underreported. Therefore, our objective was to understand factors influencing the willingness of AA/Black persons diagnosed with MM to participate in clinical trials. Methods We conducted a descriptive qualitative study between August 2021 and February 2022, recruiting 23 patients diagnosed with MM from a Comprehensive Cancer Center in North Carolina. For comparison, participants were grouped into three types of focus group discussants (FGDs), those with and without prior clinical trial enrollment and one group with a mixture of trial experience. All enrolled participants completed a researcher-captured sociodemographic survey, followed by the remote semi-structured FGD, lasting between 90-120 minutes. We used ATLAS.ti v9 and later v 23.2.1 for project management and to facilitate data analysis using the Sort and Sift, Think and Shift approach (ResearchTalk Inc). Results We conducted six focus groups: three with 13 participants without trial experience, two with 7 participants with prior experience, and one with a mix of trial experience. Participants without trial experience were younger (mean age 61 years, median 65 years, range 40-71) than those with trial experience (mean age 68 years, median 69.5 years, range 55-83). Most participants with trial experience had an associate degree or higher and higher annual pre-tax incomes ($100,000 to $149,999). Participants without experience had varied education levels but significantly lower annual incomes (&amp;lt;$30,000). All recruited participants had health insurance, with only two enrolled participants without trial experience having Medicaid insurance coverage. Factors influencing willingness to participate (Table 1) included: 1) awareness of clinical trials, 2) perceptions about trials, 3) interest in representing AA/Black persons in trials, 4) altruistic motives, and 5) perceived benefits (beneficiaries). Participants with prior trial experience often regarded clinical trials as crucial for their survival, emphasizing the significance of research in benefiting themselves and others. One participant even used the phrase “to represent a Black viewpoint” when explaining their decision to enroll in a clinical trial. While discussing perceptions, participants generally brought up unethical research practices that have affected AA/Black persons. However, they also highlighted the importance of having AA/Black representation in clinical trials. All FGDs emphasized their willingness to participate in future clinical trials, and many showed altruism by viewing it as an opportunity to “pay it forward” and contribute to the greater good, leading to positive feelings and outlooks for some. Additionally, many FGDs highlighted safety concerns for interventional therapies and the need to weigh the benefits of participation in this regard carefully . Conclusion Our study reveals that AA/Black persons with MM are willing to participate in clinical trials, regardless of prior experience, although some may initially have limited awareness of such trials. This underscores the importance of implementing multilevel approaches (individual, interpersonal, healthcare system, and policy) to enhance awareness and influence perceptions. Moving forward, we emphasize the significance of establishing community partnerships to shape educational and outreach efforts, promoting diversity in research participants. Furthermore, additional efforts are needed to ensure equitable participation opportunities for AA/Black individuals within healthcare system interactions.

Anticancer Drugs Compared to No Anticancer Drugs in Patients with Advanced Hepatobiliary Cancer: A Mapping Review and Evidence Gap Map.

Despite being commonly recommended, the impact of anticancer drugs (ACDs) on patient-important outcomes beyond survival for advanced hepatobiliary cancers (HBCs) may not have been sufficiently assessed. We aim to identify and map the evidence regarding ACDs versus best supportive care (BSC) for advanced HBCs, considering patient-centered outcomes. In this mapping review, we included systematic reviews, randomized controlled trials, quasi-experimental, and observational studies comparing ACDs (chemotherapy, immunotherapy, biological/targeted therapy) versus BSC for advanced HBCs. We searched MEDLINE (PubMed), EMBASE (Ovid), Cochrane Library, Epistemonikos, PROSPERO and clinicaltrials.gov for eligible studies. Two reviewers performed the screening and data extraction processes. We developed evidence maps for each type of cancer. We included 87 studies (60 for advanced liver cancer and 27 for gallbladder or bile duct cancers). Most of the evidence favored ACDs for survival outcomes, and BSC for toxicity. We identified several evidence gaps for non-survival outcomes, including quality of life or quality of end-of-life care. Patient-important outcomes beyond survival in advanced HBCs are insufficiently assessed by the available evidence. Future studies need to address these gaps to better inform decision-making processes.

Intraocular Lenses for Cataract Surgery

What Is the Issue?&#x0D; &#x0D; A cataract is an opacity of the lens and is the leading cause of reversible visual impairment worldwide. There are no medical treatments for cataracts but surgical procedures that replace the lens with a synthetic lens (called an intraocular lens [IOL]) have shown to be effective for restoring vision.&#x0D; Premium lenses, including lenses to correct astigmatism (called toric lenses), are available but may not be covered by public or private health plans.&#x0D; Given that there is an increased cost associated with toric lenses, there is a need to evaluate their effectiveness compared to other available corrective options, including glasses.&#x0D; &#x0D; What Did We Do?&#x0D; &#x0D; To inform decisions about the appropriate use of astigmatism-correcting IOLs, CADTH sought to identify and summarize literature that evaluates the clinical effectiveness of toric lenses against other corrective options.&#x0D; An information specialist conducted a search of peer-reviewed and grey literature sources. One reviewer screened citations, and selected and critically appraised the included studies.&#x0D; &#x0D; What Did We Find?&#x0D; &#x0D; One systematic review (SR), 3 randomized controlled trials (RCTs), 1 prospective nonrandomized study, and 6 retrospective nonrandomized studies were identified that evaluated the clinical effectiveness of toric versus nontoric IOLs implanted during cataract surgery, including 1 with a pediatric focus.&#x0D; Toric IOLs may be better than nontoric IOLs for postoperative astigmatism, but this may be dependent on the measurement of astigmatism evaluated (e.g., corneal astigmatism, residual refractive astigmatism, subjective refraction astigmatism, autorefraction astigmatism, spherical equivalent astigmatism, cylinder astigmatism, surgically induced astigmatism).&#x0D; Toric IOLs may be better than nontoric IOLs for postoperative uncorrected visual acuity (VA), but it is unclear if this results in a clinically meaningful difference to the patient. None of the studies reported on spectacle independence.&#x0D; Patient-centred outcomes were seldomly reported across the studies, and rarely used validated tools, making it difficult to conclude if there were patient-centred outcome differences between toric and nontoric IOLs.&#x0D; Harms were reported across the studies through intraoperative complications, postoperative complications, and adverse events. Postoperative complications were statistically higher in the toric group in the SR, but there were not statistically significant differences in harms reported in the primary studies.&#x0D; &#x0D; What Does it Mean?&#x0D; &#x0D; It is difficult to draw conclusions across the studies and outcomes due to the variation in how outcomes were reported or because few studies report on these outcomes.&#x0D; A proposed minimum set of core outcomes for cataract surgery was published in 2015. The studies included in this report did not align with this minimum set of outcomes. For example, as VA is not synonymous with improved visual functioning for patients, evaluating patient-reported visual functioning with a patient-reported outcome measure (PROM) tool is part of the minimum set of core outcomes. Future research should incorporate core outcomes, including PROMs.&#x0D; Although toric IOLs statistically improved uncorrected VA, when compared to nontoric lenses, statistical significance does not imply a difference that is clinically meaningful to a patient.&#x0D;

27 Technology Use in Activities of Daily Living Amongst Older Adults Referred for Memory Clinic Evaluations

Objective:The accurate assessment of instrumental activities of daily living (iADL) is essential for those with known or suspected Alzheimer's disease or related disorders (ADRD). This information guides diagnosis, staging, and treatment planning, and serves as a critical patient-centered outcome. Despite its importance, many iADL measures used in ADRD research and practice have not been sufficiently updated in the last 40-50 years to reflect how technology has changed daily life. For example, digital technologies are routinely used by many older adults and those with ADRD to perform iADLs (e.g., online financial management, using smartphone reminders for medications.) The purpose of the current study was to a) asses the applicability of technology-related iADL items in a clinical sample; b) evaluate whether technology-based iADLs are more difficult for those living with ADRD than their traditional counterparts; and c) test if adding technology-based iADL items changes the sensitivity and specificity of iADL measures to ADRD.Participants and Methods:135 clinically referred older adults (mean age 75.5 years) undergoing neuropsychological evaluation at a comprehensive multidisciplinary memory clinic were included in this study [37% with mild cognitive impairment (MCI) and 51.5% with dementia]. Collateral informants completed the Functional Activities Questionnaire (FAQ; Pfeffer, 1982) as well as 11 items created to parallel the FAQ wording that assessed technology-related iADLs such as digital financial management (i.e. online bill pay), everyday technology skills (i.e. using a smartphone; remembering a password), and other technology mediated activities (i.e. visiting internet sites; online shopping).Results:Care partners rated tech iADLs items as applicable for the majority of items. For example, technology skill items were applicable to 90.4% of the sample and online financial management questions were applicable for 76.4% of participants. Applicability ratings were similar across patients in their 60's and 70's, and lower in those over age 80. Care partners indicated less overall impairment on technology-related iADLs (M =1.22, SD =.88) than traditional FAQ iADLs (M =1.36, SD = .86), t(129) = 3.529, p =.001). A composite of original FAQ paperwork and bill pay items (M = 1.62, SD = 1.1) was rated as more impaired than digital financial management tasks (M = 1.30, SD = 1.09), t(122) = 4.77, p &lt;.001). In terms of diagnostic accuracy, tech iADL items (AUC= .815, 95% CI [.731, -.890]) appeared to perform comparably to slightly better than the traditional FAQ (AUC =.788, 95% CI [.705, .874]) at separating MCI and dementia, though the difference between the two was not statistically significant in this small pilot sample.Conclusions:Technology is rapidly changing how older adults and those with ADRD perform a host of iADLs. This pilot study suggests broad applicability of tech iADL to the lives of those with ADRD and highlights how measurement of these skills may help identify trends in iADL habits that may help to mitigate the impact of ADRD on daily functions. Further, this data suggests the need to refine and improve upon existing iADL measures to validly capture the evolving technological landscape of those living with ADRD.

Implementing early rehabilitation and mobilisation for children in UK paediatric intensive care units: the PERMIT feasibility study.

Early rehabilitation and mobilisation encompass patient-tailored interventions, delivered within intensive care, but there are few studies in children and young people within paediatric intensive care units. To explore how healthcare professionals currently practise early rehabilitation and mobilisation using qualitative and quantitative approaches; co-design the Paediatric Early Rehabilitation and Mobilisation during InTensive care manual of early rehabilitation and mobilisation interventions, with primary and secondary patient-centred outcomes; explore feasibility and acceptability of implementing the Paediatric Early Rehabilitation and Mobilisation during InTensive care manual within three paediatric intensive care units. Mixed-methods feasibility with five interlinked studies (scoping review, survey, observational study, codesign workshops, feasibility study) in three phases. United Kingdom paediatric intensive care units. Children and young people aged 0-16 years remaining within paediatric intensive care on day 3, their parents/guardians and healthcare professionals. In Phase 3, unit-wide implementation of manualised early rehabilitation and mobilisation. Phase 1 observational study: prevalence of any early rehabilitation and mobilisation on day 3. Phase 3 feasibility study: acceptability of early rehabilitation and mobilisation intervention; adverse events; acceptability of study design; acceptability of outcome measures. Searched Excerpta Medica Database, Cumulative Index to Nursing and Allied Health Literature, MEDLINE, PEDro, Open grey and Cochrane CENTRAL databases. Narrative synthesis. In the scoping review we identified 36 full-text reports evaluating rehabilitation initiated within 7 days of paediatric intensive care unit admission, outlining non-mobility and mobility early rehabilitation and mobilisation interventions from 24 to 72 hours and delivered twice daily. With the survey, 124/191 (65%) responded from 26/29 (90%) United Kingdom paediatric intensive care units; the majority considered early rehabilitation and mobilisation a priority. The observational study followed 169 patients from 15 units; prevalence of any early rehabilitation and mobilisation on day 3 was 95.3%. We then developed a manualised early rehabilitation and mobilisation intervention informed by current evidence, experience and theory. All three sites implemented the Paediatric Early Rehabilitation and Mobilisation during InTensive care manual successfully, recruited to target (30 patients recruited) and followed up the patients until day 30 or discharge; 21/30 parents consented to complete additional outcome measures. The findings represent the views of National Health Service staff but may not be generalisable. We were unable to conduct workshops and interviews with children, young people and parents to support the Paediatric Early Rehabilitation and Mobilisation during InTensive care manual development due to pandemic restrictions. A randomised controlled trial is recommended to assess the effectiveness of the manualised early rehabilitation and mobilisation intervention. A definitive cluster randomised trial of early rehabilitation and mobilisation in paediatric intensive care requires selection of outcome measure and health economic evaluation. The study is registered as PROSPERO CRD42019151050. The Phase 1 observational study is registered Clinicaltrials.gov NCT04110938 (Phase 1) (registered 1 October 2019) and the Phase 3 feasibility study is registered NCT04909762 (Phase 3) (registered 2 June 2021). This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/21/06) and is published in full in Health Technology Assessment; Vol. 27, No. 27. See the NIHR Funding and Awards website for further award information.

Developing a set of patient-centered outcomes for routine use in endometriosis: An international Delphi study.

There is large variation in individual patient care for endometriosis. A uniform approach to measure outcomes could be incorporated into routine clinical practice to personalize and monitor treatments and potentially improve the quality of care. The aim of this study is to identify a group of patient-centered outcomes for use in routine endometriosis care which are relevant to all patient profiles. By means of a modified two-round Delphi study with international representation including healthcare professionals, researchers and patient representatives (51 participants, 16 countries) we developed a set of patient-centered measurements. The participants evaluated 47 Patient Reported Outcome Measures (PROMs) and 30 Clinician Reported Outcome Measures (CROMs) regarding their feasibility and relevance for their use in routine endometriosis care. After the two rounds of quotation, meetings of the experts were convened to participate in a final discussion to finalize the consensus of the final set of included measures. The final set of patient-centered outcomes includes six PROMs (measuring symptomatic impact, pain, work productivity and quality of life) and 10 CROMs (measuring clinical, imaging and surgical indicators). A supplementary list of outcomes was added to include important dimensions that were considered essential by the expert panel but are not relevant to all patients. In addition the need for development of specific tools (PROMs) measuring the psychological impact and the impact in sexual activity of endometriosis was highlighted. We have developed a set of patient-centered outcomes measures in endometriosis care. The selected outcomes comprise the common features for all patients suffering from endometriosis. adapted for use in routine practice. The list of outcomes has been adapted for use in routine practice from which clinicians can chose, depending on their needs.

Implementing patient-centred outcome measures in palliative care clinical practice for adults (IMPCOM): Protocol for an update systematic review of facilitators and barriers.

Background: Despite the development of patient-centred or patient-reported outcome measures (PCOMs or PROMs) in palliative and end-of-life care over recent years, their routine use in practice faces continuing challenges. Objective: To update a highly cited literature review, identify and synthesise new evidence on facilitators, barriers, lessons learned, PCOMs used, models of implementation, implementation outcomes, costs, and consequences of implementing PCOMs in palliative care clinical practice. Methods: We will search MEDLINE, PsycINFO, CINAHL, Embase, Emcare, SCI-Expanded, SSCI, ESCI, and BNI. The database search will be supplemented by a list of studies from the expert advisory committee, hand-searching of reference lists for included articles, and citations of the original review. We will include primary studies using a PCOM during clinical care of adult patients with advanced disease in palliative care settings and extract data on reported models of implementation, PCOMs, facilitators, barriers, lessons learned, costs, and implementation outcomes. Gough's Weight of Evidence Framework will be used to assess the robustness and relevance of the studies. We will narratively synthesise and tabulate the findings. This review will follow PRISMA, PRISMA-Abstract, PRISMA-P, and PRISMA-Search as the reporting guidelines. Source of funding: Marie Curie. The funder is not involved in designing or conducting this study. Protocol registration: CRD42023398653 (13/02/2023).

Advances in pediatric acute kidney injury pharmacology and nutrition: a report from the 26th Acute Disease Quality Initiative (ADQI) consensus conference

BackgroundIn the past decade, there have been substantial advances in our understanding of pediatric AKI. Despite this progress, large gaps remain in our understanding of pharmacology and nutritional therapy in pediatric AKI.MethodsDuring the 26th Acute Disease Quality Initiative (ADQI) Consensus Conference, a multidisciplinary group of experts reviewed the evidence and used a modified Delphi process to achieve consensus on recommendations for gaps and advances in care for pharmacologic and nutritional management of pediatric AKI. The current evidence as well as gaps and opportunities were discussed, and recommendations were summarized.ResultsTwo consensus statements were developed. (1) High-value, kidney-eliminated medications should be selected for a detailed characterization of their pharmacokinetics, pharmacodynamics, and pharmaco-“omics” in sick children across the developmental continuum. This will allow for the optimization of real-time modeling with the goal of improving patient care. Nephrotoxin stewardship will be identified as an organizational priority and supported with necessary resources and infrastructure. (2) Patient-centered outcomes (functional status, quality of life, and optimal growth and development) must drive targeted nutritional interventions to optimize short- and long-term nutrition. Measures of acute and chronic changes of anthropometrics, body composition, physical function, and metabolic control should be incorporated into nutritional assessments.ConclusionsNeonates and children have unique metabolic and growth parameters compared to adult patients. Strategic investments in multidisciplinary translational research efforts are required to fill the knowledge gaps in nutritional requirements and pharmacological best practices for children with or at risk for AKI.

A Joint Model for Disability, Self-Rated Health, and Mortality Among Medicare Beneficiaries-Differences by Chronic Disease and Race/Ethnicity.

Quantifying interdependence in multiple patient-centered outcomes is important for understanding health declines among older adults. Medicare-linked National Health and Aging Trends Study data (2011-2015) were used to estimate a joint longitudinal logistic regression model of disability in activities of daily living (ADL), fair/poor self-rated health (SRH), and mortality. We calculated personalized concurrent risk (PCR) and typical concurrent risk (TCR) using regression coefficients. For fair/poor SRH, highest odds were associated with COPD. For mortality, highest odds were associated with dementia, hip fracture, and kidney disease. Dementia and hip fracture were associated with highest odds of ADL disability. Hispanic respondents had highest odds of ADL disability. Hispanic and NH Black respondents had higher odds of fair/poor SRH, ADL disability, and mortality. PCRs/TCRs demonstrated wide variability for respondents with similar sociodemographic-multimorbidity profiles. These findings highlight the variability of personalized risk in examining interdependent outcomes among older adults.

6.G. Workshop: Quality assessment in perioperative care: Challenges and lessons learned from the SAFEST project

Abstract Approximately 313 million surgical procedures are performed worldwide annually, with millions of patients experiencing health benefits while many suffer perioperative complications and harm. World Bank estimations show over 7 million people suffering surgical complications annually, with 4.2 million deaths occurring within 30 days of surgery, placing perioperative mortality as the third most common cause of death. Beyond the ethical issues of patients suffering personal harm while undergoing care, the burden on the health system due to prolonged length of stay and treatment is critical. Perioperative morbidity and mortality have thus become a high-priority public health problem for health systems. Attempts to set targets for improvement adopted well-known conceptual frameworks to categorise areas of evaluation (e.g., Donabedian model) and acknowledged the multifactorial root of perioperative harm and the various patient-condition and system-level factors have been fundamental in perioperative safety. International collaboration is active in seeking to address the challenges of measurement and reporting (COMPAC-StEP), while various tools have been utilised for that purpose (e.g., WHO surgical safety checklist). Several indicators, agreed among experts based on empirical research, have been adopted to assess quality at pre- intra- and postoperative care, but seen as blunt to accurately describe system performance and indicate areas of improvement. This has resulted in poorly defined measures of uncertain value, lacking validity, reliability, and lawfulness, and raising doubts about their true impact on patient safety. On the other hand, patient-centeredness and meaningfulness for patients remain unclear, while traditional clinical measures are increasingly found inadequate to capture all aspects of patient care and recovery. Overall, evidence is still conflicting regarding the most appropriate markers of quality, while long-term and patient-centred outcomes are gaining more scientific attention, despite the various implementation challenges. Greater involvement of patients in the development and selection process of quality indicators is seen as fundamental to better reflect patient values in quality targets in healthcare. A main goal of the workshop is to discuss the challenges and the latest developments in quality assessment in perioperative care and turn the attention towards “evidence-based indicators” for improving quality of care and safety in the perioperative period. The SAFEST project and its approach to developing recommendations and core indicators for patient safety in perioperative care will be presented. The special contribution of patient representatives in the SAFEST stakeholder consensus will be identified. Attributes of ideal quality indicators will be highlighted with reference to evidence-based, important reliable, and actionable indicators and those most prominent in measuring patient-related outcomes of care. Key messages • Translating perioperative safety clinical guidelines recommendations into measurable standards and assess a core of indicators will enhance the implementation of patient safety best practices.

Nurse practitioner-led, virtually delivered, motivational enhancement and device support intervention to improve CPAP adherence: A feasibility randomized control trial

BackgroundEvidence indicates continuous positive airway pressure (CPAP) therapy improves several important patient-centered outcomes. However, adherence to this safe and effective intervention remains poor. ObjectivesAssess nine feasibility outcomes of a nurse practitioner-led, virtually delivered motivational enhancement and device support (MENDS) intervention to improve CPAP adherence in adults with Obstructive Sleep Apnea (OSA). Secondary aims compared the changes in CPAP adherence to patient-reported outcomes, patient activation, and perceived self-efficacy. MethodsThis two-group feasibility randomized controlled trial included 29 patients newly diagnosed with OSA and prescribed CPAP therapy. The study was conducted from July 2020 through December 2021 at a midwestern sleep/pulmonary clinic. Participants were randomized to the MENDS intervention group (n=14) (30-45 minute interactive tele-discussions on weeks 2, 4, 6, and 8) or to the usual care (n=15) group. Feasibility, patient-reported outcomes, and behavioral constructs were measured at baseline and 12 weeks. CPAP adherence was measured weekly. ResultsFeasibility of the MENDS sessions was demonstrated (56 sessions offered, 52 completed remotely without technical difficulties) with minimal participant attrition and no missing CPAP data. Generalized linear mixed models showed no statistically significant time-by-group interactions on adherence or patient-reported outcomes. Higher adherence and lower CPAP apnea-hypopnea index (AHI) scores were associated with declines in pre- to post-changes in fatigue and sleep disturbance. Lower CPAP AHI scores were associated with pre- to post-decreases in PROMIS Anxiety scores (r=.532, p=.005). ConclusionThe virtual MENDS intervention was feasible. Higher CPAP adherence and lower AHI levels led to positive improvements in fatigue, sleep disturbance, and anxiety.

Palliative Care for Patients With Heart Failure With Preserved Ejection Fraction.

Heart failure with preserved ejection fraction (HFpEF) has become the leading form of heart failure worldwide, particularly among elderly patient populations. HFpEF is associated with significant morbidity and mortality that may benefit from incorporation of palliative care (PC). Patients with HFpEF have similarly high mortality rates to patients with heart failure with reduced ejection fraction. PC trials for heart failure have shown improvement in quality of life, quality of death, and health care utilization, although most trials defined heart failure clinically without differentiating between HFpEF and heart failure with reduced ejection fraction. As such, the timing and role of PC for HFpEF care remains uncertain, and PC referral rates for HFpEF are very low despite potential improvements in important patient-centered outcomes. Specific barriers to referral include limited data, prognostic uncertainty, provider misconceptions about PC, inadequate specialty PC workforce, complexities of treating multimorbidity, and limited home care options for patients with heart failure. While there are many barriers to integration of PC into HFpEF care, there are multiple potential benefits to patients with HFpEF throughout their disease course. As this population continues to grow, targeted efforts to study and implement PC interventions are needed to improve patient quality of life and death.