Patient-reported Outcome Measurement Tools Research Articles

Automation of ePROMs in radiation oncology and its impact on patient response and bias

PurposeThis study evaluates the impact of integrating a novel, in-house developed electronic Patient-Reported Outcome Measures (ePROMs) tool with a commercial Oncology Information System (OIS) on patient response rates and potential biases in real-world data science applications. Materials and MethodsWe designed an ePROMs tool using the NodeJS web application framework, automatically sending e-mail questionnaires to patients based on their treatment schedules in the OIS. The tool is used across various treatment sites to collect PROMs data in a real-world setting. This research examined the effects of increasing automation levels on both recruitment and response rates, as well as potential biases across different patient cohorts. Automation was implemented in three escalating levels, from telephone reminders for missing reports to minimal intervention from study nurses. ResultsFrom August 2020 to December 2023, 1,944 patients participated in the PROMs study. Our findings indicate that automating the workflows substantially reduced the patient management workload. However, higher levels of automation led to lower response rates, particularly in collecting late-phase symptoms in breast and head-and-neck cancer cohorts. Additionally, email-based PROMs introduced an age bias when recruiting new patients for the ePROMs study. Nevertheless, age was not a significant predictor of early dropout or missing symptom reports among patients participating. Notably, increased automation was significantly correlated with lower response rates in breast (p = 0.026) and head-and-neck cancer patients (p < 0.001). ConclusionIntegrating ePROMs within the OIS can significantly reduce workload and personnel resources. However, this efficiency may compromise patient responses in certain groups. A balance must be achieved between workload, resource allocation, and the sensitivity needed to detect clinically significant effects. This may necessitate customized automation levels tailored to specific cancer groups, highlighting a fundamental trade-off between operational efficiency and data quality.

Incorporating patient-reported outcome measures (PROMs) into a clinical quality registry (CQR) for ovarian cancer: considerations and challenges.

As medical treatment increasingly focuses on improving health-related quality of life, patient-reported outcome measures (PROMs) are an essential component of clinical research. The National Gynae-Oncology Registry (NGOR) is an Australian clinical quality registry. A suitable PROM was required for the NGOR ovarian cancer module to complement clinical outcomes and provide insights into outcomes important to patients. Our narrative review aimed to identify existing ovarian cancer-specific PROMs and ascertain which tool would be most appropriate for implementation into the NGOR ovarian cancer module.A literature review of Cochrane Library, Embase, MEDLINE and PubMed databases was performed to identify existing ovarian cancer-specific PROM tools. A steering committee was convened to (1) determine the purpose of, and criteria for our required PROM; and (2) to review the available tools against the criteria and recommend the most appropriate one for implementation within the NGOR.The literature review yielded five tools: MOST, EORTC QLQ-OV28, FACIT-O, NFOSI-18 and QOL-OVCA. All were developed and validated for use in clinical trials, but none had been validated for use in clinical quality registry. Our expert steering committee pre-determined purpose of a PROM tool for use within the NGOR was to enable cross-service comparison and benchmarking to drive quality improvements. They identified that while there was no ideal, pre-existing, ovarian cancer-specific PROM tool for implementation into the NGOR, on the basis of its psychometric properties, its available translations, its length and its ability to be adapted, the EORTC tool is most fit-for-purpose for integration into the NGOR.This process enabled identification of the tool most appropriate to provide insights into how ovarian cancer treatments impact patients' quality of life and permit benchmarking across health services.

Development and validation of a novel web application for patient-reported outcome measures monitoring.

e23173 Background: Patient Reported Outcome Measures (PROM) and its role in managing cancer treatment associated symptoms can not only improve the quality of life but also often prevent complication related mortality. PROM can be defined as a self-reported status of a patient's health condition without physician interpretation. One key limitation of using an app based PROM monitoring is a digital divide, (unequal distribution and knowledge regarding modern information and communication technology). Integrating PROM with technology allows for an efficient and effective method to communicate disease management. Methods: We developed a web application called Meeval consisting of two tools - PROM monitoring and medication reconciliation. Patients are able to track the severity of their symptoms on a ten point likert scale and add the medication details to their profile. We conducted a pilot study of patients with cancer who were handed a pamphlet, invited to download the app and assess its usability. We aimed to find the proportion of patients who would download and use the app following a simple introduction by the doctor using a pamphlet. We postulated that greater than fifty percent of downloads would happen, thereby negating a possible digital divide when it comes to app based PROM monitoring. Results: We recruited 95 patients with cancer. It was determined that 60% of the study population had downloaded the app without much prompt. Of this population of users, it was found that 36.8% downloaded after a seven day follow up call and 63.2% required no follow up call for app installation. When looking at app usage it was found that 53.1% of patients are tracking symptoms, 15.6% are tracking medications and 31.3% are tracking both symptoms and medication. Conclusions: The Meeval application allows for a ‘Measure, Track and Respond’ model to be implemented in a clinical setting and further enforce patient-centric healthcare. Furthermore, this app allows for seamless interaction between the patient and the physician. Patients who log their symptoms daily allow for the physician to have a more comprehensive understanding of the disease profile and any adverse effects associated with the treatment plan. Patient Reported Outcome Measures can significantly improve the quality of life and prevent any medical oversight. Through PROM tools, early detection and intervention is possible. The goal of the novel Meeval application is to improve both patient and physician experience when it comes to a chronic diagnosis and disease management. We found that the Meeval application will bridge the digital divide and provide a platform for wider use in the field of oncology.

#1030 Addressing the unmet need of patient reported outcomes in ANCA associated vasculitis, in routine clinical practice

Abstract Background and Aims ANCA associated vasculitis (AAV) is associated with increased morbidity. Recent years has seen improvement in clinical outcomes yet little work has been done to better understand the patient's role within this condition. Patient reported outcome measures (PROMs) are increasingly standard in clinical research outcomes, as well as an overall indicator for good quality patient care. With the exception of Robson et al AAV-PRO [1], little research has been done to develop validated disease specific tools for patients living with AAV. We aim to develop a disease specific tool that can be used in clinical practice to aid patients and clinicians in understanding and track changes in health-related quality of life (HRQoL) over time. Method AAV patients from a single centre were invited to take part in focus groups conducted using a semi-structured topic guide. Participants were asked to discuss topics relating to four broad areas; 1) the effects of AAV on everyday life and living, 2) the effects of treatment on everyday life and living, 3) the role of patients in health management and the patient experience 4) a review of existing generic and disease specific PROM tools (SF-36 and AAV-PRO). Audio transcript of each focus group was transcribed verbatim and data was analysed using a combination of inductive and deductive framework analysis [2]. Results Twenty-eight patients with AAV were invited to participate, 19 attended one of three, 2.5 hour focus groups, 2 patients failed to attend, 4 declined and 3 were unavailable. The mean age of participants was 66.6 +9.4 years and there was a near equal male to female split (10:9). The median time from diagnosis as 7.4 years. Three participants had active or newly diagnosed AAV with BVAS scores of &amp;gt;10. Five participants had previously required dialysis with 1 receiving a renal transplant. All participants received glucocorticoid and immunosuppressive therapy (cyclophosphamide and or Rituximab), 15 (78.9%) were still receiving immunotherapy. Full analysis of the qualitative data is being undertaken. Preliminary findings outlined what was most important to participants when considering HRQoL. Areas acknowledged included; self-identity, social roles e.g. fulfilling caring responsibilities, fears of relapse and disease and treatment burden. Fifty-six deductive and inductive codes were identified which have been further categorised. Participants felt existing tools lacked consideration of some key issues. Scoring systems were considered to be negativity worded e.g. mild, moderate, severe, with the term ‘none’ being the only positive option. Participants reported that existing tools overlooked positive factors which impact HRQoL, such as symptom validation, close clinician monitoring and improvement with treatment. Limitations were noted when trying to address transient or inconsistent symptoms and difficulty separating vasculitis from other health conditions when answering questions. Participants expressed a preference for using a PROM as part of their clinical care and felt that completing it prior to clinic would be most helpful and facilitate discussions with healthcare professionals. The use of an electronic-PROM was widely supported and would support clinicians and patients to monitor changes over time. Conclusion The AAV-PRO represents a significant advancement over generic tools such as the SF-36, however, existing PROMs are not without limitations and are primarily used in research practices. Our study revealed that patients desire active participation in HRQoL discussions and further work to incorporate this into the clinic setting is needed. We are continuing to develop a PROM tool that can be used to assess patients HRQoL in relation to their AAV in the outpatient setting. We believe this will allow a deeper understanding of the disease burden and could support a comprehensive, patient-centred approach to decision-making, offering new insights and identifying the need for supportive care. On a broader scale, these insights can be utilized to compare treatments, shed light on inequalities and facilitate enhancements in services.

#536 Dedicated patient optimization program delivers effective complex intervention improving the lives of vulnerable HD patients

Abstract Background and Aims Hemodialysis (HD) delivery is failing many patients due to a of lack of available evidence/dialysis-based interventions (previously only studied as single interventions in isolation) to improve outcomes; and the industrialization of institutional-based HD imposing a ‘one size fits all’ approach. To respond to the needs of the most vulnerable patients we have instituted a patient optimization program (POP) to support our Renal Program, fully leveraging our research level assessment tools to provide an individualized appreciation of challenges before delivering an equally individualized complex intervention. The aim was to improve subjective experience [symptoms/health related quality of life (HRQoL) measures] and objective evidence of HD related harm. Method Patients who had suboptimal tolerability to HD were identified and referred by the clinical team (after best efforts to address concern as part of standard care). To understand the patients’ individual challenges, a series of physiological, hemodynamic, and HRQoL assessments were completed. Based on these findings, a series of complex foundational (common to all patients treated) and patient specific interventions were applied, and impact rigorously evaluated. HRQoL/symptoms were measured using the dynamic patient reported outcome measurement tool LEVIL [2-4 weeks leading up to the program (baseline) and continually thereafter]. Comprehensive physiological assessment period was two weeks in length (six HD treatments) and included continuous beat to beat hemodynamic monitoring, intradialytic echocardiography (assess myocardial stunning) and objective volume assessment using ultrasound and bioimpedance. The first session was delivered mirroring routine prescription (establish primary response), subsequent treatments were delivered implementing a variety of foundational, patient/disease specific interventions in a staged manner. Results To date 13 patients have completed the program, referred for a variety of reasons [refractory hypotension (5/13), intradialytic hypotension (2/13) and poor HRQoL [symptoms—cramping, headache, pruritus, insomnia (8/13)]. Complexes of challenges were present in 9/13. All patients had multiple components of dialysis altered. POP was associated with a marked improvement in a range of subjective and objective outcomes. Subjectively, HRQoL improved by 10% [composite LEVIL scores 69.5 ± 15.5 at baseline, 76.5 ± 17 after POP participation (p 0.03)], energy by 18% (64.7 ± 16.2, 76.5 ± 6.4, p 0.01), general wellbeing by 11% (76.5 ± 6.6, 85.2 ± 4.2, p 0.02), and post-dialysis recovery improved from 13.3 ± 16.1 hours to only 2 ± 1.9 hours (p 0.02). Objectively, intradialytic weight gain decreased by 36% (2333.3 ± 1151.8 ml at baseline to 1483.3 ± 591.3 ml, p 0.03), systolic blood pressure improved by 12% [94.9 ± 28.5 mmHg at baseline to 106.2 ± 30 mmHg post optimization p &amp;lt; 0.0001 (despite midodrine being discontinued in 8/13 patients previously dependent on it)]. Tolerability of HD improved (cardiac output 6.4 ± 0.1, 6.5 ± 1, p 0.002 and intradialytic systemic vascular resistance response 15 ± 23.6% at baseline to 48.7 ± 53%, p &amp;lt; 0.0001). Improvement in hemodynamic tolerability led to a reduction in HD induced myocardial stunning larger than reported with any previously applied single intervention; regional wall motion abnormality fell from 5.6 ± 2.4 at baseline (severe stunning) to only 1.2 ± 1.3 (p 0.02) over the two-week program. 2/13 patients who had previously been declined transplantation were accepted and need to repatriate from satellite facilities to in-centre was avoided. Conclusion For the first time, we have created an opportunity for the most challenging patients who have failed conventional best efforts. We have successfully demonstrated the impact of delivering a complex intervention (with a degree of treatment personalization) targeting physiological failure in the most vulnerable HD patients. POP improved HRQoL (principal impact measure), hemodynamic stability and treatment tolerability. Having demonstrated the effectiveness of this approach, we now focus on solutions to up-scale this success.

RISK DRIVERS FOR NON-ADHERENCE IN PATIENTS TREATED FOR HYPERTENSION

Objective: Adherence to treatment remains an unmet need in hypertension with important clinical and financial consequences for patients, HCPs, and health systems. The objective of this study is to identify the behaviors of patients treated for hypertension, and specially the drivers of risk of non-adherence across 3 European countries: UK, Spain, and France. Design and method: Two questionaries were utilized for data collection: a sociodemographic and medical patient questionnaire and the SPUR questionnaire, a validated Patient-Reported Outcome Measurement tool developed by Observia. The questionnaires were taken by 122 patients with hypertension who were recruited through patient panels on random basis to avoid selection bias. Results: The recruited patient population presented following characteristics: mean age 57 years, 60% male, with the most common comorbidities being diabetes (40% of patients), dyslipidemia (33%), and depression (25%). The transversal analysis in three countries showed the most important behavioral drivers of non-adherence: - Time (score∗: 53-66) - patients underestimating future benefits of the treatment over the burden of taking it today. - Treatment risks (score∗: 44-45) – patients are concerned about potential side effects of the treatment. - Societal (score∗: 40-44) - patients worry about the impact that hypertension has on their social life (i.e., at work, social activities, interaction with acquaintances). The next three drivers for the RNA were the underestimation by the patient of the disease gravity, financial difficulties, and family life (immediate driver). This was common for all the countries of the study. Conclusions: The results provide insights on the main behavioral drivers of non-adherence to hypertension treatment. These results should be confirmed in a larger population to be used as the basis for developing patient engagement programs to increase adherence. These should be co-constructed with HCPs and patients themselves to efficiently target identified main drivers of non-adherence in hypertension. ∗The drivers of risk of non-adherence are scored using Observia's proprietary SPUR algorithm, more information can be found in publications on SPUR.

Evaluation of the German Version of the Keratoconus Outcomes Research Questionnaire.

To translate, validate, and evaluate the psychometric properties of the German version of Keratoconus Outcomes Research Questionnaire (KORQ). This prospective study included 3 phases. In phase 1, the KORQ was translated in a standardized way; in phase 2, Rasch validation was performed; in phase 3, the validated questionnaire was evaluated in a separate patient cohort. All patients answered the German KORQ. Scheimpflug imaging (Pentacam) and optical coherence tomography scans (MS-39) were conducted. Corneal imaging measurements were correlated with patient-reported outcome measures. After standardized translation, 100 patients self-administered the German KORQ. Rasch analysis was conducted for psychometric testing of the KORQ. Based on the results of the Rasch analysis, the original German version of the KORQ was modified and any items showing a misfit were excluded. This resulted in a new shortened version of the KORQ, which was evaluated in 30 patients. The revised German KORQ met the criteria of Rasch analysis and showed excellent internal consistency reliability and convergent validity. The correlation between the KORQ score and various clinical measurements was examined using Spearman correlation. A significant moderate correlation was observed between the D (r = 0.237; P = 0.006) and Kmax (r = 0.162; P = 0.065) values of Pentacam. Inverse correlations were observed for thinnest pachymetry measured with MS-39 (r = -0.167; P = 0.058) and best corrected visual acuity (r = -0.210; P = 0.016). The shortened German KORQ met the assumptions of the Rasch model and displayed satisfactory psychometric properties. The German KORQ could be adopted as a powerful patient-reported outcome measures tool for German-speaking patients with keratoconus in the future.

A systematic review of patient reported outcome measures in patients with anti-neutrophil cytoplasmic antibody associated vasculitis.

ANCA associated vasculitis (AAV) is associated with significant morbidity, fatigue, pain and poor health-related quality of life (HRQoL). This review aims to assess the comprehensiveness of existing patient reported outcome measures (PROMs) used in AAV and identify associations with poorer HRQoL outcomes. A literature review of studies using PROMs, including those labelled HRQoL in people with AAV as a primary or secondary study outcome were screened and reviewed up to July 2023. Quality was assessed using the Critical Appraisal Skills Programme. A total of 30 articles were included which utilised 22 different PROM tools. 76.7% (n = 23) used the SF-36 or a variation as a generic measure of health status and or HRQoL. Two studies developed a disease specific PROM. The AAV-PRO showed good psychometric properties but potential limitations in capturing all relevant aspects of the disease experience for AAV patients. Factors associated with poorer HRQoL included: neurological and sinonasal involvement, women and younger patients. 86.6% of studies showed no meaningful relationships between the SF-36 and BVAS, VDI or disease duration. Depression and anxiety were common and socioeconomic factors such as unemployment were significantly associated with poorer mental health outcomes. Glucocorticoids were found to be independently associated with worse SF-36 scores. Generic PROMs are useful in measuring significant changes but lack sensitivity to specific symptoms and unique AAV-related issues, while existing disease specific PROMs have limitations and may not fully capture AAV patient's perspective on disease and treatment burden.

Abstract 11518: Patient Reported Outcomes Measures Are Infrequently Used in Clinical Studies of Heart Transplant Recipients

Introduction / Background: The goals of heart transplantation (HT) are to improve symptoms, restore quality of life, and extend survival. Clinical trials in HT recipients have largely focused on objective outcomes such as measures of cardiac function and survival; however, a paucity of data exists regarding the use of patient reported outcome measures (PROMs) as outcomes in these studies. Aims: We aimed to characterize the use of PROMs in registered clinical trials of HT recipients. Methods: All clinical studies of adult HT recipients were queried from ClinicalTrials.gov, and studies were stratified by inclusion of PROMs. Studies reporting PROMs were identified via specific search terms using the “outcomes measures” field. Summary statistics compared characteristics of studies that did versus did not report PROMs. Results/Data: Between November 1999 and August 2022, 227 studies of HT recipients were registered on ClinicalTrials.gov. At least one PROM was reported in 11% (n=24/227) of registered studies. Studies reporting PROMs were more likely to be conducted outside of the United States (91.7% vs 54.2%, p&lt;0.001) and report a greater number of total primary/secondary outcomes (PROMs: median 7 [IQR: 4, 9] vs. No PROMs: median 3 [IQR: 2, 6]; p&lt;0.001). The majority of studies reporting PROMs (58.3%) were initiated after 2020. Twenty-one distinct PROM tools/domains were reported as outcome measures, with the Short Form Health Survey 36 being most frequently used (n=10/24). Thirteen of the 21 PROMs included questions assessing mental health, whereas only three PROM tools were cardiac-specific (Figure). Conclusions: Only about one in ten registered clinical trials of HT recipients include PROMs, and mental health was the most commonly assessed domain when a PROM was included. Development and validation of PROM tools is needed to assess the multifaceted nature of health-related quality of life in HT recipients.

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;

Applicability of Patient-Reported Outcome Measures to Aesthetic Medicine Patient Archetypes.

Patient-reported outcome measures (PROMs) are valuable in understanding patient motivations, setting expectations, and ensuring satisfaction. As the aesthetic industry expands globally, factors that motivate the treatment goals of the aesthetic patient reflect evolving social, cultural, and commercial influences. This article will assess the applicability of current PROMs used in aesthetic medicine to an increasingly diverse patient population and consider their ability to measure the underlying motives that drive different types of patients to pursue their specific goals. PubMed database was searched for studies using PROMs to evaluate the motivations and expectations of aesthetic patients. Seven validated aesthetic PROM tools were reviewed against a backdrop of different patient segments as represented by the 4 patient archetypes: Positive Aging, Beautification, Correction, and Transformation. None of the tools could universally represent the individual motivations and expectations of all 4 patient archetypes. There is a need for updated PROMs in aesthetics that are applicable to patients with different motivations or expected outcomes than the traditional rejuvenation patient. PROMs that help decode patient motivations and that are developed with more diverse patient involvement will help aesthetic clinicians better understand the goals and expectations of new patient segments.

Psychometric Characteristics, Cross-Cultural Adaptation and Validation of the Slovenian Version of the Victorian Institute of Sports Assessments for Gluteal Tendinopathy Questionnaire (VISA-G).

Greater trochanteric pain syndrome (GTPS) denotes several disorders around the lateral aspect of the hip. GTPS may develop in native hips as well as after total hip arthroplasty (THA). It is estimated that 5-12% of patients suffer from GTPS after primary THA. Despite the prevalence of GTPS, it is hard to diagnose and manage it properly. The VISA-G questionnaire was developed as a patient-reported outcome measurement tool for evaluation of GTPS. The aims of the present study were to evaluate the reliability of the VISA-G Slovenian and its construct and criterion validity. After the finalization of the VISA-G Slovenian translation procedure, 59 patients with a painful trochanteric region planned for THA filled in the VISA-G Slovenian at the hospital on two occasions 5-7 days apart. On the first occasion, each patient also filled in the EQ-5D-5L questionnaire and the Harris Hip Score (HHS) was completed by the physiotherapist. The VISA-G Slovenian was found to have a test-retest reliability of ICC 0.977; 95% CI [0.96; 0.986]. Internal consistency was assessed with Cronbach's alpha 0.79. The statistically significant, but low, correlation between the HHS and VISA-G (r=0.48) was obtained. Concurrent validity of the VISA-G with the EQ-5D-5L showed moderate to strong correlations in Mobility, Self-Care, Usual Activities, Pain, EQ-5D-5L Index and EQ VAS, but low correlation in the Anxiety subscale. No floor and ceiling effect were obtained. The VISA-G Slovenian has excellent psychometric properties needed to measure gluteal tendinopathy-related disability of patients in Slovenia. Thus, we recommend using the questionnaire for measuring trochanteric hip pain.

Current Validated Clinical and Patient Reported Disease Outcome Measures in Juvenile Idiopathic Arthritis.

Juvenile idiopathic arthritis (JIA) is a common chronic illness in childhood and comprises seven categories based on the International League of Associations for Rheumatology (ILAR) criteria. Accurate assessment and measurement of the clinical, functional, and quality of life outcomes of patients with JIA are paramount for understanding the disease course and formulating effective treatment strategies. Interest in the development and use of outcome measurements specifically focused on rheumatologic conditions has greatly expanded over the last two decades, adding to and improving upon the established disease measures. Furthermore, many of these measures have been validated using the widely accepted Outcome Measures in Rheumatology (OMERACT) core principles of instrument validation, allowing researchers and clinicians to gain confidence in these tools. This review summarizes the current validated disease outcome measures in JIA, including clinical, imaging, patient-reported, and functional outcome measurement tools, and highlights ongoing work that continues to refine and improve upon the available tools. The clinical disease outcome measures discussed in this review include physician global assessment (PhGA), American College of Rheumatology (ACR, Wallace) criteria for clinical inactive disease and clinical remission, juvenile arthritis disease activity scores (JADAS), juvenile spondyloarthritis disease activity index (JSPaDA), juvenile arthritis damage index (JADAI), and the ACR pediatric response scores. The imaging outcome measures discussed include the Dijkstra composite scores, childhood arthritis radiographic score of the hip (CARSH), and Poznanski Score. The patient-reported disease outcome measures discussed include patient global assessment (PtGA), patient-reported outcome measurement information system for JIA (PROMIS), juvenile arthritis parent/child centered disease assessment index (JAPAI, JACAI), juvenile arthritis multidimensional assessment report (JAMAR), and the Pediatric quality of life inventory rheumatology module (PedsQL). The functional outcome tools discussed include the Childhood Health Assessment Questionnaire (CHAQ), juvenile arthritis functionality scale and index (JAFS and JASI), and Juvenile Arthritis Functional Assessment Report and Scale (JAFAS and JAFAR).

Translation and validation of the Norwegian version of the postoperative quality of recovery score QoR-15.

As patient-centered care gains more attention, assessing the patient's perspective on their recovery has become increasingly important. In response to the need for a reliable and valid patient reported outcome measurement tool for major surgical resections in Norway. The Norwegian Registry for Gastrointestinal Surgery (NORGAST) initiated a project to translate and evaluate QoR-15's psychometric properties for patients going through general, gastrointestinal (GI), and hepato-pancreato-biliary (HPB) resectional surgery. After a translation and adaption of the original version of QoR-15 into Norwegian, the QoR-15NO was psychometrically evaluated including a confirmatory factor analysis to test for unidimensionality, as well as tests for content validity, internal consistency, measurement error, construct validity, feasibility, and responsiveness. This process included cognitive interviews using a structured interview guide. Further, patients who underwent various types of GI/HPB surgery at five hospitals in different parts of Norway completed the QoR-15NO before surgery and on the first or second day after surgery. The impact of surgery was classified according to Surgical Outcome Risk Tool v2 (SORT), in extra major/complex, major, intermediate, and minor. This study included 324 patients with 83% return rate with both pre- and postoperative forms. There were negative correlations between duration of surgery and postoperative QoR-15 score and the difference between post- and preoperative score (change score). Individuals who had gone through surgery with major impact had a lower postoperative mean QoR-15 score (97) than their counterparts who had experienced either medium (QoR-15: 110) or minor (QoR15: 119) impact surgery. Cronbach's alpha (0.88) and Omega Alpha Total (ωt = 0.90) indicate that the scale has good to very good internal consistency. Test-retest reliability was measured by Intra-class Correlation Coefficient to ICC = 0.70. Confirmatory factor analyses supported that a one-factor model with correlated residuals had a good fit to data. This study supports QoR-15NO as a valid, essentially unidimensional, feasible, and responsive instrument among patients undergoing general, GI, and HPB resectional surgery in Norway. The total QoR-15NO score provides important information that can be used in an everyday clinical setting and integrated into NORGAST.

Patient-Reported Outcome Measurement and Minimal Clinically Important Difference for Hand Surgeons.

Patient-reported outcome measurement (PROM) tools are used to evaluate health status and response to treatment and have been integral in the effort to improve the quality of care provided. Patient reported outcomes (PROs) have garnered additional attention since becoming a priority of the National Institutes of Health in the early part of this century, and their use in both clinical practice and research has subsequently increased. In the upper extremity, a variety of PRO instruments exist that can assist physicians in their ability to track and/or prognosticate outcomes, make comparisons between treatments as well as strengthen research methodologies, and help determine the value of care. A more complete interpretation of the clinical significance of patient-reported outcome measurements is informed by parameters such as minimal clinically important difference, substantial clinical benefit and patient acceptable symptom state.

Utility of Patient-Reported Symptom and Functional Outcomes to Indicate Recovery after First 90 Days of Radical Cystectomy: A Longitudinal Study.

This is a longitudinal prospective study that tracked multiple symptom burden and functioning status for bladder cancer (BLC) patients for 3 months post-radical cystectomy at The University of Texas MD Anderson Cancer Center, using a validated disease-specific patient-reported outcome measure (PROM) tool, the MD Anderson Symptom Inventory (the MDASI-PeriOp-BLC). The feasibility of collecting an objective measure for physical functioning, using "Timed Up & Go test" (TUGT) and PRO scores at baseline, discharge and end of study, was tested. Patients (n = 52) received care under an ERAS pathway. The more severe scores of fatigue, sleep disturbance, distress, drowsiness, frequent urination and urinary urgency at baseline predicted poor functional recovery postoperatively (OR = 1.661, 1.039-2.655, p = 0.034); other more severe symptoms at discharge (pain, fatigue, sleep disturbance, lack of appetite, drowsiness, bloating/abdominal tightness) predicted poor functional recovery (OR = 1.697, 1.114-2.584, p = 0.014) postoperatively. Compliance rates at preoperative, discharge and end of study were 100%, 79% and 77%, while TUGT completion rates were 88%, 54% and 13%, respectively. This prospective study found that more severe symptom burden at baseline and discharge is associated with poor functional recovery post-radical cystectomy for BLC. The collection of PROs is more feasible than using performance measures (TUGT) of function following radical cystectomy.

P110 Challenges of meeting NICE guidance for rheumatoid arthritis in the modern era: a service audit

Abstract Background/Aims NICE guidance for patients with rheumatoid arthritis (RA) (NG100) states all patients should receive an annual review appointment. This should encompass assessment of disease activity metrics, co-morbidity review and appropriate onward referral to other healthcare professionals. A preliminary snapshot service review in 2020 had suggested that our department’s adherence to NICE RA guidance was inconsistent. This assessed small patient numbers, so a larger audit was devised enabling us to better understand current practice and inform areas for future development. Methods NG100 was fully reviewed, and relevant audit standards devised. JE and BM created metrics demonstrating compliance with guidance; areas requiring clarification were discussed with AA. 3400 adult RA patients were identified under the care of the department. The records of 340 patients were selected for review using convenience sampling. All clinic encounters were reviewed for 12 months prior to an identified appointment in January 2019. Data was collected by HC, reviewed by JE, and analysis completed by HC, JE and AA. Results Female to male ratio was 2.33:1, mean age was 65.9 (SD = 12.3), median DAS28 score was 2.94 (IQR=2.01), median VAS score was 40.0 (IQR=63.5). 74% (n = 251/340) of patients were reviewed more than once in 12 months. 41% (n = 141/340) of appointments were with nurses, 35% (n = 118/340) with consultants, 10% (n = 34/340) with SHOs, 14% (n = 47/340) with registrars. DAS28 was documented for 74.4% (n = 253/340) of patients. Presence or absence of erosions was documented for 42% (n = 144/340) of patients. Blood pressure was documented in 33% (n = 113/340) of patients, 18% (n = 60/340) patients were known to have hypertension, 6% (n = 20/340) of patients had ischemic heart disease. Assessment for metrics relating to audit standards: mental health screen 7.9% (n = 27/340), neck pain 14% (n = 46/340), respiratory symptoms 21% (n = 72/340), eye symptoms 21% (n = 70/340), bone health 27.9% (n = 95/340). There was documented consideration of referral to allied health professionals in 38% (n = 128/340) and to surgical teams in 18% (n = 61/340). Quantitative assessment of patient-reported outcome measures (PROMs) included: VAS 73% (n = 248/340), HAQ 22% (n = 76/340). Conclusion There is variation amongst clinicians in documenting NICE guidance annual review targets for RA; this may reflect time pressure in clinics, incomplete documentation, and unclear delineation of primary and secondary care roles. Secondary care should be aware of the quality framework targets for primary care relating to RA monitoring to encourage collaboration and optimise use of resources. Developing virtual assessments and PROM tools provides new opportunities for shared responsibility of care between clinicians and patients; this could improve patient outcomes. We are developing a digital RA annual review tool incorporating PROMs to simplify documentation and reduce pressures on clinic times; this may improve patient and clinician experience. Disclosure H. Cooney: None. J. Ellis: None. B. Mulhearn: None. A. Allard: None.

Validity and Reliability of Turkish Version of the Munich Wrist Questionnaire in Patients With Wrist Problems.

Evidence for the validity and reliability of the Turkish version of the Munich Wrist Questionnaire (MWQ), a patient reported outcome measurement tool (PROM) was evaluated. A total of 80 patients (54.1 ± 1.4years, 68 females) with wrist problems were recruited. The MWQ was translated into Turkish (MWQ-TR). Criterion validity with Patient-Rated Wrist Evaluation (PRWE) and Disabilities of the Arm, Shoulder and Hand (DASH) was tested by using Pearson's correlation coefficients. Intraclass correlations coefficient (ICC) was used to analyze the test-retest reliability. There was a moderate correlation (r = -0.49, p < 0.001) between MWQ-TR and DASH, while correlations were strong between MWQ-TR and PRWE (r = 0.69, p < 0.001). Test-retest reliability of MWQ-TR was moderate (ICC = 0.67, 95% CI 0.26-0.84). The MWQ-Turkish version demonstrated evidence for its validity and reliability to evaluate pain, work/daily life activities and function in people with wrist problems in a Turkish population.

On the sensitivity of PROMs during breast radiotherapy

PurposeTo investigate the sensitivity of patient-reported outcome measures (PROMs) to detect treatment-related side effects in patients with breast cancer undergoing external beam photon radiotherapy. MethodsAs part of daily clinical care, an in-house developed PROM tool was used to assess side effects in patients during a) whole-breast irradiation (WBI) to 40 Gy, b) WBI with a sequential boost of 10 Gy, and c) partial-breast irradiation (PBI) to 40 Gy. Results414 patients participated in this prospective study between October 2020 and January 2022, with 128 patients (31 %) receiving WBI, 241 (58 %) receiving WBI followed by a sequential boost, and 50 patients (12 %) receiving PBI. Significant differences in the reported toxicities (itching, radiation skin reaction, skin darkening, and tenderness and swelling) were reported between the WBI cohorts with and without boost (p < 0.001, p < 0.001, p < 0.001, and p = 0.002, respectively). The comparison of PBI with WBI (no-boost) yielded significant differences for radiation skin reaction (p < 0.001). ConclusionThe results highlight the high sensitivity of PROMs to detect treatment-related side effects in patients with breast cancer. Thus, PROMs may be a valuable tool for quality control and may support evidence-based learning from real-world data originating from daily routine care.

Amplifying the Patient Voice: A Survey of Practitioners' Use of Patient-reported Outcome Measures Across Radiotherapy Providers in England

AimsThe NHS England Radiotherapy Service Specification calls for routine use of patient-reported outcome measures (PROMs). However, barriers exist at patient, healthcare professional and service levels. The aim of the present study was to determine the current use of PROMs within radiotherapy services in England. The current attitudes, barriers and enablers to the implementation of PROMs in radiotherapy practice were evaluated and practical recommendations to inform future implementation were developed. Materials and methodsA mixed-methods approach was adopted to obtain quantitative and qualitative data. An online questionnaire was developed and disseminated to all radiotherapy operational delivery network managers across England. The questionnaire consisted of 12 open and closed questions relating to PROMs use, with the option to provide free-text responses. Inductive thematic analysis was conducted on free-text comments, whereas descriptive statistics were used to analyse quantitative data. ResultsIn total, 182 responses were received from 40 of the 50 radiotherapy providers, resulting in a response rate of 84%. The current use of PROMs was analysed, including rationale for use, tools used, format of PROMs collection and timing within the radiotherapy pathway. Most respondents indicated that PROMs were used in the context of clinical trials only. Through thematic analysis, four identical key themes were identified relating to both barriers and enablers to PROMs use; these included IT infrastructure, time, human/financial resources and training/education. A fifth theme, standardisation, was identified as a key enabler to PROMs use. ConclusionsOur findings show that outside of clinical trials, PROMs are not routinely used in radiotherapy services due to barriers identified at professional and service levels. Here we provide recommendations to mitigate the barriers identified and implement PROMs in radiotherapy, including training for healthcare professionals and standardisation of PROMs tools and storage. This study provides a key first step in driving PROMs implementation within radiotherapy services across England.