Assessment Of Patient-reported Outcomes Research Articles

The feasibility and value of assessing patient-reported outcomes in pulmonary arterial hypertension.

Pulmonary arterial hypertension (PAH) is a progressive pulmonary vascular disease that negatively impacts health‐related quality of life (HRQOL). The PAH‐symptoms and impact (PAH‐SYMPACT) questionnaire is a validated disease‐specific patient‐reported outcome (PRO) instrument that assesses a patient's symptoms and the impact of PAH and its treatment on well‐being. We performed a single‐center prospective cohort study of patients with PAH to determine the feasibility of assessing PROs in clinical practice and to determine the association between PAH‐SYMPACT domains and clinical characteristics and outcomes. One hundred and ten patients completed the 1‐day version of the PAH‐SYMPACT questionnaire which consists of 22 Likert‐scale questions that assess HRQOL across four domains: cardiopulmonary (CP) symptoms, cardiovascular (CV) symptoms, physical impact (PI), and cognitive and emotional (CE) impact. Higher scores indicate worse HRQOL. Patients were predominantly female (n = 86, 78%) with a mean age of 57.8 ± 16.2 years. While several patient characteristics were associated with CP and PI domains, few were associated with CV and CE domains. PI and CE impact scores were associated with recent hospitalizations and mortality and CE impact score was independently associated with an increased risk of death after adjustment for disease severity (hazard ratio: 3.29, 95% confidence interval: 1.56–6.91, p = 0.002). In conclusion, the assessment of PROs in clinical practice using the PAH‐SYMPACT questionnaire is both feasible and valuable. PAH‐SYMPACT scores have independent prognostic value and are not adequately reflected by traditional measures of disease severity. These findings underscore the importance of assessing HRQOL in clinical practice.

Health-Related Quality of Life in Patients With High-Grade Glioma: A Systematic Review

Abstract AIMS Several studies have evaluated health-related quality of life (HRQoL) through patient-reported outcomes (PROs) in high-grade glioma (HGG) patients. No systematic review has summarised this increasingly important research area. METHOD Seven electronic databases were systematically searched. Primary research articles evaluating HRQoL in HGG patients through PRO assessment were included. Global, physical, mental, and social health were summarised descriptively. Risk of bias (RoB) of included studies was assessed using The Joanna Briggs Institute Critical Appraisal tool or Newcastle Ottawa Scale. Quality of study reporting was assessed using a modified ISOQOL checklist. RESULTS Twenty-six studies were included (4,451 patients): cross-sectional (n=14), longitudinal (n=12). RoB and quality of reporting were satisfactory. Ten PRO measurement instruments were identified, of which EORTC-QLQ-C30 (n=15) was utilised most frequently. Fatigue significantly impacted both physical and global health. HRQoL improved after surgery but recurrence, fatigue, and difficulties with activities of daily living were associated with worsening HRQoL. HGG patients had higher anxiety and depression scores than the general population, negatively impacting overall HRQoL. Social health was superior for patients with good supportive networks, but a majority do not return to full-time employment post-diagnosis. Long-term survivors reported improvements in their physical, social and emotional functioning over time. CONCLUSION With HGG life expectancy less than 12 months post-diagnosis, HRQoL is of paramount importance to patients. PRO assessment of HRQoL can be used to evaluate self-reported functioning and well-being in both routine practice and clinical trial settings and provide opportunities for timely intervention.

VOCAL (Views of Ovarian Cancer patients-how maintenance therapy Affects their Lives) study: A lens into the financial and quality of life (QoL) impact of disease burden and ethnic disparities reported directly by the patient.

274 Background: Limited real-world (RW) financial burden and QoL data exist for patients (pts) with advanced ovarian cancer (aOC). Differences in QoL have yet to be explored based on ethnicity. Methods: This cross-sectional online survey included US aOC pts who completed first line (1L) treatment, were ≥18 years, and eligible for 1L maintenance (1Lm). Financial burden was measured by employment status, health insurance coverage, household income, and expenses. QoL was measured by 2 validated patient-reported outcome (PRO) measures: EQ-5D-3L (mobility, self care, activities, pain/discomfort, and anxiety/depression; reported as no, some, or extreme problems) and EORTC QLQ-C30 (functional and symptomatic items). Results: 152 pts from 27 states were surveyed. The most common ethnicities were White (W; 104 [68%]), Black/African American (B/AA; 19 [12%]), Hispanic and Latino (H/L; 11 [7%]). 76 (50%) were not working (unemployed, retired, on disability, or long-term sick leave); 45 of these did not work due to aOC (W: 27/104 [26%], B/AA: 10/19 [53%], H/L: 4/11 [36%]). W pts spent the most on medical costs (mean [SD]: $396.60 [SD: 996.10]) and tests/labs ($133.50 [483.89]). Active surveillance was the most common aOC treatment (39% [W: 41%; B/AA: 32%, H/L: 36%]). Over a quarter of W (27%) and H/L (27%) pts, and nearly half of B/AA (48%) pts were receiving IV 1Lm for aOC. Fewer H/L and B/AA pts were offered genetic testing compared with W pts (27% and 58% vs 83%, respectively). On EQ-5D-3L dimensions, a higher proportion of W pts reported no problem with walking (W: 72%, B/AA: 53%, H/L: 55%), self care (W: 94%, B/AA: 79%, H/L: 64%), usual activities (W: 53%, B/AA: 26%, H/L: 27%), and no pain/discomfort (W: 52%, B/AA: 32%; H/L: 36%). B/AA pts reported the lowest current health status score (mean [SD] EQ-5D VAS score: 53.5 [18.46]). 19% of pts reported extreme anxiety/depression, the highest proportion was seen for H/L (5; 45%) followed by B/AA (7; 37%) and W (10; 10%) pts. Of the EORTC-QLQ-C30 functioning items (100 = highest functioning), the highest impact was seen on emotional functioning (mean [SD]: 59.8 [26.56]; W: 65.5 [23.83], B/AA: 48.2 [28.13], H/L: 53.0 [29.17]). Of the symptom items (100 = highest impact), the highest score was seen for insomnia (mean [SD] 39.5 [30.79]; W: 39.4 [28.54], B/AA: 35.1 [30.38], H/L: 48.5 [45.62]) and fatigue (mean [SD] 36.1 [26.89]; W: 34.4 [26.34], B/AA: 46.2 [29.22], H/L: 33.3 [32.96]). Conclusions: This novel assessment of RW financial burden and PROs by ethnicity signals important health disparities for B/AA and H/L vs W pts, highlighting a need to improve quality of care and support for pts of these ethnicities.

Associations between drug and alcohol use, smoking, and frailty among people with HIV across the United States in the current era of antiretroviral treatment

ObjectiveTo examine associations between frailty and drug, alcohol, and tobacco use among a large diverse cohort of people with HIV (PWH) in clinical care in the current era. MethodsPWH at 7 sites across the United States completed clinical assessments of patient-reported measures and outcomes between 2016 and 2019 as part of routine care including drug and alcohol use, smoking, and other domains. Frailty was assessed using 4 of the 5 components of the Fried frailty phenotype and PWH were categorized as not frail, pre-frail, or frail. Associations of substance use with frailty were assessed with multivariate Poisson regression. ResultsAmong 9336 PWH, 43% were not frail, 44% were prefrail, and 13% were frail. Frailty was more prevalent among women, older PWH, and those reporting current use of drugs or cigarettes. Current methamphetamine use (1.26: 95% CI 1.07–1.48), current (1.65: 95% CI 1.39–1.97) and former (1.21:95% CI 1.06–1.36) illicit opioid use, and former cocaine/crack use (1.17: 95% CI 1.01–1.35) were associated with greater risk of being frail in adjusted analyses. Current smoking was associated with a 61% higher risk of being frail vs. not frail (1.61: 95% CI 1.41–1.85) in adjusted analyses. ConclusionsWe found a high prevalence of prefrailty and frailty among a nationally distributed cohort of PWH in care. This study identified distinct risk factors that may be associated with frailty among PWH, many of which, such as cigarette smoking and drug use, are potentially modifiable.

A Review of Patient-Reported Outcome Measures in Childhood Cancer.

Patient-reported outcomes (PROs) are used in clinical work and research to capture the subjective experiences of childhood cancer patients and survivors. PROs encompass content domains relevant and important to this population, including health-related quality-of-life (HRQOL), symptoms, and functional status. To inform future efforts in the application of PRO measures, this review describes the existing generic and cancer-specific PRO measures for pediatric cancer populations and summarizes their characteristics, available language translations, content coverage, and measurement properties into tables for clinicians and researchers to reference before choosing a PRO measure that suits their purpose. We have identified often unreported measurement properties that could provide evidence about the clinical utility of the PRO measures. Routine PRO assessment in pediatric cancer care offers opportunities to facilitate clinical decision-making and improve quality of care for these patients. However, we suggest that before implementing PRO measures into research or clinical care, the psychometric properties and content coverage of the PRO measures must be considered to ensure that PRO measures are appropriately assessing the intended construct in childhood cancer patients.

Palliative Care Outcome Scale Assessment for Cancer Patients Eligible for Palliative Care: Perspectives on the Relationship between Patient-Reported Outcome and Objective Assessments.

(1) Background: The importance of patient-reported outcome (PRO), i.e., prioritizing patient voice, has increased in cancer treatment, as well as palliative and supportive settings. The Integrated Palliative Care Outcome Scale (IPOS), a hybrid evaluation consisting of “patient evaluation” (PRO) and “peer evaluation” by medical professionals, was developed as a successor version of the Support Team Assessment Schedule (STAS) in 2013 and has been utilized worldwide. The Japanese version of the IPOS (IPOS-J) was developed and released in 2019. The purpose of this study was to explore the applicability of the IPOS-J to clinical practice in the future. (2) Methods: We conducted the following two studies with terminally ill cancer patients: (i) Can an evaluation with the IPOS-J performed by medical professionals (peer evaluation) replace the STAS-J evaluation? (ii) Can the quality of palliative care improve by combining the IPOS-J patient evaluation with the peer evaluation? (3) Results: The overall intervention rate and urgent intervention rate for the STAS-J and IPOS-J was 34.4 vs. 34.1% (p = 0.91) and 10.4 vs. 9.9% (p = 0.78), respectively. The patients selected “intervention required” but the medical professionals selected “no intervention required” in 47 cases. The medical team performed appropriate intervention after re-assessment. As a result, more than 70% of the patients were “intervention-free” after 1 week of intervention. (4) Conclusions: The IPOS-J peer evaluation was as useful as the STAS-J evaluation. A hybrid type of evaluation, combining patient evaluation (PRO) and peer evaluation, may help us to understand patient needs and improve the quality of palliative care.

Risk Factors for Suboptimal Adherence Identified by Patient-Reported Outcomes Assessments in Routine HIV Care at 2 North American Clinics.

PurposeUse of patient-reported outcomes assessments (PROs) can improve patient–provider communication and focus provider attention on current health issues. This analysis examines the association between suboptimal antiretroviral therapy (ART) adherence and factors obtained through PROs among people with HIV (PWH) at 2 North American outpatient clinics.Patients and MethodsImmediately before a clinic visit, PWH completed self-administered PROs. Unadjusted and adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were estimated from logistic regression models to identify sociodemographic and health-related factors (satisfaction with ART, difficulty meeting housing costs, depression, intimate partner violence, risk of malnutrition, smoking status, alcohol use, and substance use) associated with suboptimal adherence (defined as self-reporting <95% or <80% adherence). Multiple imputation was performed to account for missing data in the multivariate analyses.ResultsOf 1632 PWH, 1239 (76%) responded to the adherence assessment; of these, 268 (22%) and 106 (9%) reported <95% and <80% adherence, respectively. Of 1580 PWH who responded, 354 (22%) were dissatisfied with their HIV medication. Of responding PWH, 19% reported moderate-to-severe depression, 23% indicated they were at risk of malnutrition, 34% were current smokers, and 62% reported substance use in the past 3 months. Dissatisfaction with ART was significantly associated with <95% and <80% adherence in the unadjusted analysis (unadjusted OR [95% CI], 3.38 [2.51–4.56] and 4.26 [2.82–6.42], respectively) and adjusted analysis (adjusted OR [95% CI], 2.76 [1.91–4.00] and 3.28 [1.95–5.52], respectively); significance remained after multiple imputation. In adjusted analyses, no risk of malnutrition was significantly associated with reduced odds of <95% adherence after multiple imputation (adjusted OR [95% CI], 0.714 [0.511–0.997]); no other factors were associated with <95% or <80% adherence.ConclusionThese results suggest that implementation of PROs evaluating treatment satisfaction may provide value to adherence management in routine HIV care.

Exploring the Patient Experience with Patient-Reported Outcomes: A Qualitative, Multistakeholder Study.

Although the literature provides guidance regarding patient-reported outcome (PRO) implementation barriers, patients' perspectives are underreported. This study aimed to improve the understanding of patient experiences with PRO tools through examining perceptions of and attitudes toward PROs and expectations of data use after collection. Ethnographic human-centered design approaches were used to conduct free-form interviews. Two case studies of existing PRO use in clinics also were examined. Unstructured thematic analyses were performed using notes taken during these interviews. Patients generally reported a good understanding of the need for PRO collection, both for research and clinical use. Many expected that results would be acted upon by the clinicians promptly. Thematic analyses identified the following patient perception topics: transparency, individualization to patient needs, timely response, different "identities" while accessing care locally compared with at a destination center, and preference for brief PROs. Design and implementation of PRO assessments into patient care should include the patients as key end users. Transparency of the purpose for data collection is critical for broader patient adoption. Ensuring that only necessary and sufficient data are collected for clinical action, and associated research may help minimize burden and maximize patient participation.

Evaluation of the key geriatric assessment constructs in primary brain tumor population - a descriptive study

IntroductionDespite an increasing aging population, older adults (≥ 65 years) with primary brain tumors (PBTs) are not routinely assessed for geriatric vulnerabilities. Recent reports of geriatric assessment (GA) in patients with glioblastomas demonstrated that GA may serve as a sensitive prognosticator of overall survival. Yet, current practice does not include routine evaluation of geriatric vulnerabilities and the relevance of GA has not been previously evaluated in broader cohorts of PBT patients. The objective of this descriptive study was to assess key GA constructs in adults with PBT dichotomized into older versus younger groups. Materials and MethodsA cross-sectional analysis of data collected from 579 participants with PBT recruited between 2016 and 2020, dichotomized into older (≥ 65 years, n = 92) and younger (≤ 64 years, n = 487) from an ongoing observational trial. GA constructs were evaluated using socio-demographic characteristics, Charlson Comorbidity Index (CCI), polypharmacy (>5 daily medications), Karnofsky Performance Status (KPS), Neurologic Function Score (NFS), and patient-reported outcome assessments including general health, functional status, symptom burden and interference, and mood. Descriptive statistics, t-tests, chi-square tests, and Pearson correlations were used to evaluate differences between age groups. ResultsOlder participants were more likely to have problems with mobility (58% vs. 44%), usual activities (64% vs 50%) and self-care (38% vs 26%) compared to the younger participants (odds ratios [ORs] = 1.3–1.4, ps < 0.05), while older participants were less likely to report feeling distressed (OR = 0.4, p < 0.05). Older participants also had higher CCI and were more likely to have polypharmacy (OR = 1.7, ps < 0.05). Increasing age strongly correlated with worse KPS score (r = −0.232, OR = 1.4, p < 0.001) and worse NFS (r = 0.210, OR = 1.5, p < 0.001). No differences were observed in overall symptom burden, symptom interference, and anxiety/depression scores. DiscussionWhile commonly used GA tools were not available, the study employed patient- and clinician-reported outcomes to identify potential future research directions for the use of GA in the broader neuro-oncology population. Findings illustrate missed opportunities in neuro-oncology practice and underscore the need for incorporation of GA into routine care of this population. Future studies are warranted to further evaluate the prognostic utility of GA and to better understand functional aging outcomes in this patient population.

Adaptation of the Patient Reported Outcome Measurement Information System (PROMIS) tool for childhood cancer in India: A qualitative study.

To fill the gap in patient-reported outcome (PRO) assessment in children with cancer in India, we planned to adapt domains from the HealthMeasures Patient Reported Outcomes Measurement Information System (PROMIS) tool. This study attempted to identify and pool outcomes relevant to children with cancer and their caregivers in Northern India. The study was qualitative and conducted through focussed group discussions (FGDs) and in-depth interviews of children with cancer and their caregivers. Content analysis of transcripts from the sessions was done. The collected themes were collated with existing item banks of the PROMIS tool and new concepts unique to our population were compiled. A set of three FGDs and 14 interviews each for children and their caregivers were conducted. Following content analysis, 121 themes were identified including 10 new concepts. Themes pertaining to the physical domain were cited most. The theme distribution across the three domains was similar among children and caregivers. In the survivor cohort, the relative frequency of mention of psychological and social themes was higher compared to the whole cohort. Themes pertaining to mobility, cognitive dysfunction and peer relationships were more common among survivors. This qualitative study in children with cancer and their caregivers in India has facilitated a better understanding of the issues pertaining to cancer care that are of most importance to its stake holders. The themes collected may be used to formulate a PRO tool uniquely tailored for use in this population.

Patient-reported outcomes in the GARNET trial in patients with advanced or recurrent mismatch repair-deficient/microsatellite instability-high endometrial cancer treated with dostarlimab

ObjectiveThere is an increase in patient-reported outcome assessments to gain information on new drug candidates from the patient’s perspective. A data gap remains in patient-reported outcome measurements for anti-programmed death...

Validation and Application of MD Anderson Symptom Inventory Module for Patients with Bladder Cancer in the Perioperative Setting.

Simple SummaryPatients’ perspectives should be incorporated into the perioperative care plan in patients with bladder cancer undergoing cystectomy. Our approach incorporated both patients’ perspectives and clinicians’ points of view to develop and validate the MDASI-PeriOp-BLC module. The MDASI-PeriOp-BLC module was found to be a valid, reliable, and concise tool to assess symptom burden and functional recovery in this specific cohort of patients.Objectives: We developed and validated a disease-specific tool for perioperative patient-reported outcomes assessment for bladder cancer (BLC) patients undergoing radical cystectomy, The MD Anderson Symptom Inventory (the MDASI-PeriOp-BLC). Methods: Patients who underwent radical cystectomy were recruited. We used qualitative interviews and experts’ input to generate disease/treatment-specific items of the MDASI-PeriOp-BLC module; conducted item reduction; examined the psychometric properties of the resultant items for reliability, validity, and clinical interpretability; and conducted cognitive debriefing interviews to assess the tool’s performance. Results: A total of 150 BLC patients contributed to psychometric validation. We identified and defined eight BLC-specific module items (blood in urine, leaking urine, frequent urination, urinary urgency, burning with urination, constipation, changes in sexual function, and stomal problems). We included those 8 items in addition to 13 MDASI core symptoms and 6 interference items to form the MDASI-PeriOp-BLC module. Cronbach alphas were 0.89 and 0.90 for the 21 severity items and the 6 interference items, respectively. Test–retest reliability (intra-class correlation) was 0.92 for the 21 severity items. The MDASI-PeriOp-BLC module significantly differentiated the patients by performance status (p < 0.0001). Conclusions: The MDASI-PeriOp-BLC is a valid, reliable, and concise tool for monitoring symptom burden during perioperative care in BLC patients undergoing radical cystectomy.

Quality of Life and Physical Activity in 629 Individuals With Sarcoidosis: Prospective, Cross-sectional Study Using Smartphones (Sarcoidosis App).

BackgroundLarge gaps exist in understanding the symptomatic and functional impact of sarcoidosis, a rare multisystem granulomatous disease affecting fewer than 200,000 individuals in the United States. Smartphones could be used for prospective research, especially for rare diseases where organizing large cohorts can be challenging, given their near ubiquitous ownership and ability to track objective and subjective data with increasingly sophisticated technology.ObjectiveWe aimed to investigate whether smartphones could assess the quality of life (QoL) and physical activity of a large cohort of individuals with sarcoidosis.MethodsWe developed a mobile app (Sarcoidosis App) for a prospective, cross-sectional study on individuals with sarcoidosis. The Sarcoidosis App was made available on both Apple and Android smartphones. Individuals with sarcoidosis were recruited, consented, and enrolled entirely within the app. Surveys on sarcoidosis history, medical history, and medications were administered. Patients completed modules from the Sarcoidosis Assessment Tool, a validated patient-reported outcomes assessment of physical activity, fatigue, pain, skin symptoms, sleep, and lungs symptoms. Physical activity measured by smartphones was tracked as available.ResultsFrom April 2018 to May 2020, the App was downloaded 2558 times, and 629 individuals enrolled (404, 64.2% female; mean age 51 years; 513, 81.6% White; 86, 13.7% Black). Two-thirds of participants had a college or graduate degree, and more than half of them reported an income greater than US $60,000. Both QoL related to physical activity (P<.001, ρ=0.250) and fatigue (P<.01, ρ=–0.203) correlated with actual smartphone-tracked physical activity. Overall, 19.0% (98/517) of participants missed at least 1 week of school or work in an observed month owing to sarcoidosis, and 44.4% (279/629) reported that finances “greatly” or “severely” affected by sarcoidosis. Furthermore, 71.2% (437/614) of participants reported taking medications for sarcoidosis, with the most common being prednisone, methotrexate, hydroxychloroquine, and infliximab. Moreover, 46.4% (244/526) reported medication side effects, most commonly due to prednisone.ConclusionsWe demonstrate that smartphones can prospectively recruit, consent, and study physical activity, QoL, and medication usage in a large sarcoidosis cohort, using both passively collected objective data and qualitative surveys that did not require any in-person encounters. Our study’s limitations include the study population being weighted toward more educated and wealthier individuals, suggesting that recruitment was not representative of the full spectrum of patients with sarcoidosis in the United States. Our study provides a model for future smartphone-enabled clinical research for rare diseases and highlights key technical challenges that future research teams interested in smartphone-based research for rare diseases should anticipate.

Hernia Defect Closure With Barbed Suture: An Assessment of Patient-reported Outcomes in Extraperitoneal Robotic Ventral Hernia Repair.

Primary closure of a fascial defect during ventral hernia repair is associated with lower rates of recurrence and better patient satisfaction compared with bridging repairs. Robotic surgery offers enhanced ability to close these defects and this has likely been aided by the use of barbed suture. The goal of this study was to evaluate the perioperative safety and the long-term outcomes for the use of barbed suture for the primary closure of hernia defects during robotic ventral hernia repair (rVHR) with mesh. This is a retrospective study of adult patients who underwent rVHR with the use of a barbed suture for fascial defect closure from August 2018 to August 2020 in an academic center. All the patients included were queried by phone to complete a quality of life assessment to assess patient-reported outcomes (PROs). Subjective sense of a bulge and pain at the previous hernia site has been shown to correlate with hernia recurrence. These questions were used in conjunction with a Hernia-related Quality of Life Survey (HerQles) score to assess a patient's quality of life. A total of 81 patients with 102 hernias were analyzed. Sixty patients (74%) were successfully reached and completed the PRO form at median postoperative day 356 (range: 43 to 818). Eight patients (13% of patients with PRO data) claimed to have both a bulge and pain at their previous hernia site, concerning for possible recurrence. Median overall HerQLes score was 82 [Interquartile Range (IQR): 54 to 99]. Patients with a single hernia defect, when compared with those with multiple defects, had a lower rate of both a bulge (15% vs. 30%) and symptoms (33% vs. 48%), as well as a higher median HerQLes score (85 vs. 62) at the time of PRO follow-up. Patients with previous hernia repair had a lower median HerQLes score of 65 (IQR: 43 to 90) versus 88 (IQR: 62-100). These patients also had a higher rate of sensing a bulge (29% vs. 18%), whereas a sense of symptoms at the site was less (33% vs. 44%). Barbed suture for fascial defect closure in rVHR was found to be safe with an acceptable rate of possible recurrence by the use of PRO data. Patients with multiple hernias and previous repairs had a higher likelihood of recurrence and a lower quality of life after rVHR.

Patient-Reported Outcomes from the Phase 3 Randomized, Double-Blind, KEYNOTE-826 Trial of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (023)

Patient-Reported Outcomes from the Phase 3 Randomized, Double-Blind, KEYNOTE-826 Trial of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (023)

Effects of Metabolic Medicine and Metabolic Surgery on Patient-Reported Outcomes Among Patients with Type 2 Diabetes.

The assessment and management of patient-reported outcomes (PROs) is considered secondary to that of cardiometabolic outcomes. When assessed, health-related quality of life (HRQOL), a PRO, can yield pertinent information that cannot be obtained from cardiometabolic assessments. For instance, physical and mental distress can be quantified and treated. Moreover, treatment convenience and satisfaction can be gaged. Behavioral modification, bariatric surgery, and pharmacotherapy can improve PROs. Typically, HRQOL is responsive to changes in weight. Specifically, weight loss and weight gain are associated with positive and negative changes in quality of life, respectively. In addition, patient satisfaction can be influenced by glycemic control. Therefore, hypoglycemia and hyperglycemic episodes can negatively affect patient satisfaction. When managing type 2 diabetes (T2D), it is important to consider how therapies impact PROs. Generally, changes in clinical outcomes mirror changes in PROs. To best manage T2D, integrating the assessment of PROs with clinical outcomes is needed.

A review of patient-reported outcome assessments in registration trials of FDA-approved new oncology drugs (2014–2018)

The Food and Drug Administration (FDA) encourages the assessment of patient-reported outcomes (PROs) in oncology clinical trials. A 2015 review showed that approximately 26% of industry-sponsored oncology trials included assessment of PROs. However, the proportion of recent trials that supported new oncology drug approvals and assessed PROs is unknown. This review found that assessment of PROs was included in about 75% of registration trials that supported 55 new FDA drug approvals during 2014–2018. Patient-reported outcome assessment was included more in randomized controlled trials than in open-label trials (88% vs. 69%, respectively) and more in phase 3 than in phase 2 trials (89% vs. 66%, respectively).

An implementation study of electronic assessment of patient-reported outcomes in inpatient radiation oncology

PurposeDespite evidence for clinical benefits, recommendations in guidelines, and options for electronic data collection, routine assessment of patient-reported outcomes (PROs) is mostly not implemented in clinical practice. This study aimed to plan, conduct and evaluate the implementation of electronic PRO (e-PRO) assessment in the clinical routine of an inpatient radiation oncology clinic.MethodsThe guideline- and evidence-based, stepwise approach of this single-center implementation study comprised preparatory analyses of current practice, selection of assessment instruments and times, development of staff training, and evidence-based recommendations regarding the use of the e-PRO assessment, as well as on-site support of the implementation. Process evaluation focused on potential clinical benefit (number of documented symptoms and supportive measures), feasibility and acceptance (patient contacts resulting in completion/non-completion of the e-PRO assessment, reasons for non-completion, preconditions, facilitators and barriers of implementation), and required resources (duration of patient contacts to explain/support the completion).ResultsSelection of instruments and assessment times resulted in initial assessment at admission (EORTC QLQ-C30, QSR 10), daily symptom monitoring (EORTC single items), and assessment at discharge (EORTC QLQ-C30). Recommendations for PRO-based clinical action and self-management advice for patients concerning nine core symptoms were developed. Staff training comprised group and face-to-face meetings and an additional e-learning course was developed. Analyses of clinical records showed that e-PRO assessment identified more symptoms followed by a higher number of supportive measures compared to records of patients without e-PRO assessment. Analysis of n = 1597 patient contacts resulted in n = 1355 (84.9%) completed e-PROs (initial assessment: n = 355, monitoring: n = 967, final assessment: n = 44) and n = 242 (15.2%) non-completions. Instructions or support to complete e-PROs took on average 5.5 ± 5.3 min per patient contact. The most challenging issue was the integration of the results in clinical practice.ConclusionE-PRO assessment in oncologic inpatient settings is acceptable for patients and can support symptom identification and the initiation of supportive measures. The challenge of making the “data actionable” within the clinical workflow and motivating clinical staff to use the results became evident.

Poster 214: Posterior Tibial Slope Reducing Osteotomy in Complex Revision Anterior Cruciate Ligament Reconstruction

Poster 214: Posterior Tibial Slope Reducing Osteotomy in Complex Revision Anterior Cruciate Ligament Reconstruction

Tailoring Pain Interference Measurement in People with Cancer: A Feasibility Study.

Most patient-reported outcomes (PRO) are not directly tailored to an individual patient's values, partially because tailored PROs require clinical interviews or are difficult to use in statistical analyses. This study tested a method for tailoring pain PROs, Precision PROs, that can be implemented, and analyzed using standard statistical tests. People with cancer and pain (n=231) completed an online survey and then a second survey (n=161) one to two weeks later. Participants reviewed the PROMIS pain interference item bank, chose the four items most important to their quality of life, and then completed those items. Kappas compared choices between the two surveys. Participants completed measures of pain intensity, physical function, and a standard pain interference measure. All participants were able to select four items that were personally meaningful. Only one item (enjoyment of life) was chosen by more than half the sample (50.6%). Kappas for item choice were in the moderate to nearly perfect range for 32 of 35 items. The majority of the sample (59%) preferred tailoring their own PRO questions to completing a previously determined, non-patient-specific PRO. The Precision PRO scores had similar associations with pain intensity and physical function as the standard pain interference measure. The Precision PRO approach was feasible, more preferred by patients, and showed consistency over a short timeframe. This approach could be used to make PRO assessment in clinical care and clinical trials more patient-centered. Additional research is needed to determine the generalizability of this approach to other outcomes and populations.