Generic Outcome Measures Research Articles

Cross-cultural adaptation and validation of Carolinas Comfort Scale to Brazilian Portuguese for inguinal hernia.

Inguinal hernias are highly prevalent worldwide and its surgical repair is one of the most common procedures in general surgery. The broad use of mesh has decreased the recurrence rates of inguinal hernia to acceptable levels, thus centering the attention on Quality of Life as a pivotal postoperative outcome. Carolinas Comfort Scale is a well-studied questionnaire designed to identify Quality of Life changes following hernia repair with mesh techniques. The aim of this study is to validate the CCS in Brazilian Portuguese for inguinal hernias. The original CCS was translated into Brazilian Portuguese according to cross-cultural adaptation guidelines. We conducted a cross-sectional study in individuals aged 18 and above who had undergone inguinal laparo-endoscopic hernia repair for at least 6months prior, between January 2019 and August 2022, at a Brazilian tertiary hospital. Participants answered an online survey containing the Brazilian CCS and the generic Patient-Reported Outcome Measure (PROM) Short-Form Health 36 (SF-36). Participants answered the same questionnaires in the follow-up after at least three weeks, with an additional question about satisfaction with surgery results. The survey was completed by 115 patients, of whom 78 (67%) responded to the follow-up questionnaire after 3 to 10weeks. CCS showed excellent internal consistency, with Cronbach's α of 0.94. Intraclass correlation coefficient ranged from 0.60 to 0.82 in the test-retest analysis. Compared to SF-36, a strong correlation was observed in the physical functioning dimension, and a moderate correlation was found in role-physical and bodily pain (Pearson's Coefficient Correlation = 0.502, 0.338 and 0.332 respectively), for construct analysis. The mean CCS score was significantly lower (p < 0.001) among satisfied patients compared to the unsatisfied ones. The Brazilian version of CCS is a valid and reliable method to assess long-term quality of life after inguinal laparo-endoscopic hernia repair.

Responsiveness and minimal important change of specific and generic patient-reported outcome measures for back patients: the Norwegian Neck and Back Register

PurposeTo evaluate responsiveness and minimal important change (MIC) of Oswestry Disability Index (ODI), pain during activity on a numeric rating scale (NRSa) and health related quality of life (EQ-5D) based on data from the Norwegian neck and back registry (NNRR).MethodsA total of 1617 patients who responded to NNRR follow-up after both 6 and 12 months were included in this study. Responsiveness was calculated using standardized response mean and area under the receiver operating characteristic (ROC) curve. We calculated MIC with both an anchor-based and distribution-based method.ResultsThe condition specific ODI had best responsiveness, the more generic NRSa and EQ-5D had lower responsiveness. We found that the MIC for ODI varied from 3.0 to 9.5, from 0.4 to 2.5 for NRSa while the EQ5D varied from 0.05 to 0.12 depending on the method for calculation.ConclusionIn a register based back pain population, the condition specific ODI was more responsive to change than the more generic tools NRSa and EQ5D. The variations in responsiveness and MIC estimates also indicate that they should be regarded as indicative, rather than fixed estimates.

Optimising personal continuity for older patients in general practice: a cluster randomised stepped wedge pragmatic trial

AimTo evaluate the effectiveness, feasibility and acceptability of a multicomponent intervention for improving personal continuity for older patients in general practice.DesignA cluster randomised three-wedged, pragmatic trial during 18 months.Setting32 general...

Surgical Intervention is Associated with Improvement in Health-Related Quality of Life Outcomes in Patients with Symptomatic Sacral Tarlov Cysts: Results from a Prospective Longitudinal Cohort Study

The treatment of symptomatic Tarlov cysts remains a controversial topic within neurosurgery. We describe our experience with patients who underwent surgical intervention for sacral Tarlov cysts at a single institution. General and disease-specific outcome measures were used to assess health-related quality of life. Patients who underwent surgical treatment for one or more sacral Tarlov cysts between 2018 and 2021 were included. The Tarlov Cyst Quality of Life (TCQoL), a validated disease-specific measure, was the primary outcome of the study. Secondary outcomes included general outcome measures: 36-Item Short Form Survey, the Oswestry Disability Index, and Visual Analog Scale. Patients were followed at 3, 6, and 12 months postoperative. Repeated measures analyses were used to assess change from preoperative to 12 months postoperative. Data were obtained from 144 patients who underwent surgery for sacral Tarlov cysts, average age 52.3 ± 11.3 years, 90.3% female. Patients reported significant mean improvement on the TCQoL over time (preoperative 3.2±0.1; 3-months postoperative 2.1±0.1; 6-months 1.9±0.1; 12-months 1.9±0.1; P< 0.001). Patient age and duration of symptoms were not associated with outcome. 82.3% of patients reported improvement on TCQoL. There was not a significant difference in the proportion of patients reporting improvement on TCQoL by cyst size (small 90.9% vs. large 77.9%; P = 0.066). Our longitudinal series demonstrated patient-reported improvement following surgery for symptomatic sacral Tarlov cysts using a validated disease-specific health-related quality of life scale through 12 months following surgery. Patient age and preoperative duration of symptoms were not correlated with outcome.

Hip-specific and generic patient-reported outcome measure scores after primary hip replacement are associated with early revision surgery: a national registry study

BackgroundThe ability to efficiently identify patients at higher risk of poor outcomes after joint replacement would enable limited resources for post-operative follow-up to be directed to those with the greatest clinical need. This is particularly important as joint replacement rates continue to grow internationally, stretching health system capabilities. Patient-reported outcome measures (PROMs) are routinely administered in many settings and offer an opportunity to detect suboptimal patient outcomes early. This study aimed to determine whether hip-specific and generic PROM scores are associated with early revision hip replacement within six to 24 months after the primary procedure.MethodsPre-operative and six-month post-operative PROM scores for patients undergoing primary total hip replacement (THR) were obtained from the Australian Orthopaedic Association National Joint Replacement Registry and Arthroplasty Clinical Outcomes Registry National and linked to revision surgery data. Clinically important improvement was defined using anchor-based thresholds. Associations between PROM scores (hip pain, Oxford Hip Score, HOOS-12, EQ-5D-5L, EQ VAS, patient-perceived change, satisfaction) and revision surgery were evaluated using t-tests, chi-square tests and regression models.ResultsData were analysed for 21,236 primary THR procedures between 2013 and 2022. Eighty-eight revision procedures were performed at six to 24 months. Patients who were revised had more back pain and worse HOOS-12 scores pre-operatively but between-group differences were small. Worse post-operative PROM scores (hip pain, Oxford, HOOS-12, EQ-5D-5L, EQ VAS) were associated with early revision, after adjusting for age and sex (p < 0.001 for all analyses). Patient dissatisfaction (relative risk (RR) 10.18, 95%CI 6.01–17.25) and patient-perceived worsening (RR 19.62, 95%CI 11.33–33.98) were also associated with a higher likelihood of revision. Patients who did not achieve clinically important improvement in hip pain, function, or quality of life had a higher revision risk (RRs 2.54–5.64), compared with those who did (reference).ConclusionSix-month hip-specific and generic PROM scores can identify patients at higher risk of early revision surgery. Our data highlight the utility of routine post-operative PROM assessment for signaling suboptimal surgical outcomes.

Disruption of hospital care during the first year of the COVID-19 pandemic impacted socioeconomic groups differently: population based study using routine registration data

BackgroundDuring the COVID-19 pandemic, provision of non-COVID healthcare was recurrently severely disrupted. The objective was to determine whether disruption of non-COVID hospital use, either due to cancelled, postponed, or forgone care, during the first pandemic year of COVID-19 impacted socioeconomic groups differently compared with pre-pandemic use.MethodsNational population registry data, individually linked with data of non-COVID hospital use in the Netherlands (2017–2020). in non-institutionalised population of 25–79 years, in standardised household income deciles (1 = low, 10 = high) as proxy for socioeconomic status. Generic outcome measures included patients who received hospital care (dichotomous): outpatient contact, day treatment, inpatient clinic, and surgery. Specific procedures were included as examples of frequently performed elective and acute procedures, e.g.: elective knee/hip replacement and cataract surgery, and acute percutaneous coronary interventions (PCI). Relative risks (RR) for hospital use were reported as outcomes from generalised linear regression models (binomial) with log-link. An interaction term was included to assess whether income differences in hospital use during the pandemic deviated from pre-pandemic use.ResultsHospital use rates declined in 2020 across all income groups. With baseline (2019) higher hospital use rates among lower than higher income groups, relatively stronger declines were found for lower income groups. The lowest income groups experienced a 10% larger decline in surgery received than the highest income group (RR 0.90, 95% CI 0.87 – 0.93). Patterns were similar for inpatient clinic, elective knee/hip replacement and cataract surgery. We found small or no significant income differences for outpatient clinic, day treatment, and acute PCI.ConclusionsDisruption of non-COVID hospital use in 2020 was substantial across all income groups during the acute phases of the pandemic, but relatively stronger for lower income groups than could be expected compared with pre-pandemic hospital use. Although the pandemic’s impact on the health system was unprecedented, healthcare service shortages are here to stay. It is therefore pivotal to realise that lower income groups may be at risk for underuse in times of scarcity.

Pathways to—But Not Through? Revisiting the Trauma and Recidivism Relationship Among System-Involved Youth

Research has demonstrated that exposure to traumatic experiences in childhood and adolescence can result in adverse outcomes, including mental health concerns, school troubles, delinquency, and juvenile justice system involvement. The current study draws on a framework informed by feminist pathways and trauma theories to revisit the effect of traumatic experiences on recidivism two years following initial system contact. Data from a Midwestern juvenile court illustrated traumatic experiences are common pathways into the system but are not predictive of experiences through the system using general recidivism outcome measures. However, several other variables predicted youth receiving new petitions. The effects of race/ethnicity and age are more pronounced when the sample was disaggregated by referral unit (truancy vs. delinquency unit). We discuss different methodological and measurement factors to consider when examining the trauma-recidivism relationship.

The effect of nonsteroidal anti-inflammatory drug use on soft tissue and bone healing in the knee: a systematic review.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used to mitigate pain and inflammation associated with musculoskeletal conditions; however, there is conflicting data on the adverse effects of these drugs on tissue and bone healing. The objective of this study was to investigate the effect of NSAIDs on the healing of knee, soft tissue, and bone. A systematic literature search was conducted across PubMed/MEDLINE, Excerpta Medical Database (Embase)/Ovid, and the Cochrane Central Register of Controlled Trials databases. Clinical, animal, and in vitro studies on the effect of NSAIDs on knee healing were included. Risk of bias assessment was performed using the Cochrane bias assessment tool and Methodological Index for Non-Randomized Studies scoring system for included clinical studies, and the Systematic Review Center for Laboratory Animal Experimentation assessment tool for all included animal studies. General study population characteristics, interventions used, NSAIDs utilized, outcome measures, and study results were analyzed using descriptive statistics. Fifteen articles met the inclusion criteria. Of the 15 studies, there were three clinical, ten animal, and two in vitro studies. In clinical studies, nonselective cyclooxygenase (COX) inhibitors and selective COX-2 inhibitors did not cause a significant increase in failure of anterior cruciate ligament (ACL) reconstructions or meniscal repairs with NSAID administration pre-, peri-, or post-operatively in comparison to placebo or no NSAID administration. Among animal studies assessing COX-2 inhibitor effects on soft tissue, healing was impaired (2/4), delayed but unaffected (1/4), or unaffected (1/4). In animal studies assessing COX-1 inhibitors, ligament healing was either increased (1/4), unaffected (2/4), or impaired (1/4). Meanwhile, administration of non-selective COX inhibitors in animals did not affect soft tissue (3/3) and cartilage (1/1) healing. Two in vitro studies identified a negative outcome on patellar tendon and ACL cell proliferation or viability after non-selective COX inhibition and variable results after selective COX-2 inhibition. Animal studies on postoperative NSAID use after knee surgery suggest that administration of selective and nonselective COX-2 inhibitors may impair healing of soft tissue, bone and tendon-to-bone; however, further clinical studies are needed to better characterize dose and duration dependent risks of NSAIDs.

An Exploration of a General Social Outcome Measure

The General Social Outcome Measure (GSOM) is a performance-based measurement tool designed to assess the change in social skills performance during and after intervention for students with social skills deficits. In the current study, the psychometric properties of the GSOM, including the total score and social communication domains, were examined in adolescents with social skill deficits. Internal consistency alphas were conducted, which showed promising results. Correlational analyses were conducted using the GSOM and the Children’s Communication Checklist-2 (CCC-2), School Social Behavior Scales (SSBS), and the Autism Diagnostic Observation Schedule–Second Edition (ADOS-2). A small but significant correlation was documented between the GSOM and the ADOS-2, with higher GSOM total scores (higher social skills) associated with lower ADOS-2 scores. Additional analyses revealed that individuals with different levels of symptomology according to the ADOS-2 (low, moderate, or high) differed significantly in the GSOM total score. The implications of these findings are discussed with respect to the utility of the GSOM as a progress-monitoring tool for targeted populations with social skill impairments.

Effect of avalglucosidase alfa on disease-specific and general patient-reported outcomes in treatment-naïve adults with late-onset Pompe disease compared with alglucosidase alfa: Meaningful change analyses from the Phase 3 COMET trial

BackgroundThe Phase 3 COMET trial (NCT02782741) comparing avalglucosidase alfa and alglucosidase alfa included health-related quality of life (HRQoL) assessments in treatment-naïve patients with late-onset Pompe disease (LOPD). Here, we further characterize results from disease-specific and general patient-reported outcome (PRO) measures. MethodsAdults who participated in the COMET trial receiving avalglucosidase alfa or alglucosidase alfa (both 20 mg/kg biweekly) during the 49-week double-blind treatment period were included in the analysis. Proportions of patients exceeding meaningful change thresholds at Week 49 were compared post hoc between treatment groups. PROs and their meaningful change thresholds included: Pompe Disease Severity Scale (PDSS; decrease 1.0–1.5 points), Pompe Disease Impact Scale (PDIS; decrease 1.0–1.5 points), Rasch-built Pompe-specific Activity Scale (R-PAct; change from unable to able to complete activity), 12-item Short Form Health Survey (SF-12; physical component summary [PCS] score: increase ≥6 points, mental component summary [MCS] score: increase ≥7 points), EuroQol 5 Dimension 5 Level (EQ-5D-5L; improvement of ≥1 category), and Patient Global Impression of Change (PGIC; any improvement). ResultsThe analysis included 99 adult patients (avalglucosidase alfa n = 50; alglucosidase alfa n = 49). Patients who received avalglucosidase alfa had significantly greater odds of achieving a meaningful change versus alglucosidase alfa for the PDSS Shortness of Breath (OR [95% CI] 11.79 [2.24; 62.18]), Fatigue/Pain (6.24 [1.20; 32.54]), Morning Headache (13.98 [1.71; 114.18]), and Overall Fatigue (5.88 [1.37; 25.11]) domains, and were significantly more likely to meet meaningful change thresholds across multiple PDSS domains (all nominal p < 0.05). A numerically greater proportion of patients in the avalglucosidase alfa group were able to complete selected activities of the R-PAct compared with the alglucosidase alfa group. Significantly greater proportions of patients who received avalglucosidase alfa achieved meaningful improvements for EQ-5D-5L usual activities dimension, EQ visual analog scale, and all four PGIC domains. The proportion of patients with improvements in SF-12 PCS and MCS was greater in the avalglucosidase alfa group versus alglucosidase alfa group, but was not significant (p > 0.05). ConclusionsThese analyses show that avalglucosidase alfa improves multiple symptoms and aspects of daily functioning, including breathing and mobility. This supports the clinical relevance of the effects of avalglucosidase alfa on HRQoL for patients with LOPD.

Responsiveness of specific and generic patient-reported outcome measures in patients with plantar fasciopathy

Purpose To evaluate and compare responsiveness characteristics for the Foot Function Index revised short form (FFI-RS), RAND-12 Health Status Inventory (RAND-12), and Numeric Rating Scale (NRS), in patients with plantar fasciopathy receiving non-surgical treatment. Materials and methods This study was conducted on a sub-group of patients from an ongoing randomised controlled trial. One-hundred fifteen patients were included. The patient-reported outcome measures (PROMs) were applied at baseline and after 6 months. Responsiveness was calculated using standardised response mean and area under the receiver operating characteristic (ROC) curve. ROC curves were used to compute the minimal important change (MIC) for the outcome measures. Results The region specific FFI-RS had best responsiveness and the NRS at rest had lowest responsiveness. Conclusion FFI-RS were marginally more responsive than the other PROMs. Responsiveness and MIC estimates should be regarded as indicative rather than fixed estimates.

Development of an implementation strategy for routine collection of generic patient reported outcome measures: a qualitative study in multidisciplinary community rehabilitation

Purpose To explore staff perceptions of barriers and enablers towards implementing the EQ-5D-5L in community rehabilitation, and develop a theory-informed implementation approach for routine administration of generic patient-reported outcome measures (PROMs) using implementation science frameworks. Materials and methods A qualitative study was conducted at three sites. Multidisciplinary rehabilitation staff completed individual semi-structured interviews, which were transcribed and coded against the Theoretical Domains Framework (TDF). We identified and selected potentially effective behaviour change techniques using the Behavior Change Wheel. Hypothetical strategies were operationalised. Results Twenty-one interviews were conducted, and four themes emerged: (1) The Impact of PROMs on patient centered-care; (2) Considerations for validity of PROMs; (3) Service-level impact of embedding PROMs; (4) Practical issues of embedding PROMs within the service. Barriers and enablers were mapped to seven of the TDF domains; relating most to clinicians’ “belief about consequences”, “reinforcement”, and “environmental context and resources”. Five hypothetical strategies were developed to overcome identified barriers and strengthen enablers. Key behaviour change techniques underpinning the strategies include: restructuring the physical environment, incentivisation, persuasion and education, enablement, and, social support. Conclusions Our implementation approach highlights the importance of automating processes, engaging site champions, routinely reporting, and using PROM data to inform service provision.

Health Status of US Patients With One or More Health Conditions: Using a Novel Electronic Patient-reported Outcome Measure Producing Single Metric Measures.

Most existing research studying health status impacted by morbidity has focused on a specific health condition, and most instruments used for measuring health status are neither patient-centered nor preference-based. This study aims to report on the health status of patients impacted by one or more health conditions, measured by a patient-centered and preference-based electronic patient-reported outcome measure. A cross-sectional study was conducted among patients with one or more health conditions in the United States. A novel generic, patient-centered, and preference-based electronic patient-reported outcome measure: Château Santé-Base, was used to measure health status. Individual health state was expressed as a single metric number (value). We compared these health-state values between sociodemographic subgroups, between separate conditions, between groups with or without comorbidity, and between different combinations of multimorbidity. The total sample comprised 3913 patients. Multimorbidity was present in 62% of the patients. The most prevalent health conditions were pain (50%), fatigue/sleep problems (40%), mental health problems (28%), respiratory diseases (22%), and diabetes (18%). The highest (best) and lowest health-state values were observed in patients with diabetes and mental health problems. Among combinations of multimorbidity, the lowest values were observed when mental health problems were involved, the second lowest values were observed when fatigue/sleep problems and respiratory diseases coexisted. This study compared health status across various single, and multiple (multimorbidity and comorbidity) health conditions directly, based on single metric health-state values. The insights are valuable in clinical practice and policy-making.

Development and validation of a novel personalized electronic patient-reported outcome measure to assess quality of life (Q-LIFE): a prospective observational study in people with Cystic Fibrosis

Generic and disease-specific patient-reported outcome measures (PROMs) may lack relevance and sensitivity on a patient-level in chronic diseases with differential disease expression and high individual variability, such as Cystic Fibrosis (CF). This study aimed to develop and validate a novel personalized electronic PROM (ePROM) that captures relevant aspects of quality of life in individuals with CF. The Q-Life app was developed as a short personalized ePROM to assess individual quality of life. Psychometric properties were assessed in a single-center cross-sectional study between September 2019 and September 2021 and in a prospective cohort study between September 2021 and September2022. Combined studies included 223 participants (median age: 24 years, IQR: 19.0-32.5 years, range: 12.0-58.0 years). Internal consistency (Cronbach's alpha: 0.83-0.90) and test-retest reliability (intraclass correlation coefficient: 0.90; 95% CI: 0.65-0.92; p<0.001) of quality of life (Q-Life) scores were strong. Q-Life scores were associated with overall Cystic Fibrosis Questionnaire-Revised (CFQ-R) scores (ρ=0.71; p<0.001), CFQ-R respiratory domain scores (ρ=0.57; p<0.001) and forced expiratory volume in 1s (ρ=0.41; p<0.001). Furthermore, Q-Life scores improved from 65.0 (IQR: 45.0-63.3) at baseline to 84.2 (IQR: 75.0-95.0) and 87.5 (IQR: 75.0-100.0) after 3 and 6 months of elexacaftor/tezacaftor/ivacaftor treatment (change: 20.8; 95% CI: 17.5-25.0; p<0.001), comparable to CFQ-R respiratory domain scores (change: 22.2, 95% CI: 19.4-25.0, p<0.001). The Q-Life app is a reliable, valid and sensitive personalized ePROM to measure all aspects of quality of life that really matter to individuals with Cystic Fibrosis. This patient-centered approach could provide important advantages over generic and disease-specific PROMs in the era of personalized medicine and value-based healthcare. Dutch Cystic Fibrosis Foundation, Health-Holland.

Patient perspectives on consequences of resection for colorectal cancer: A qualitative study.

Colorectal cancer is diagnosed in approximately 500,000 patients each year in Europe, leading to a high number of patients having to cope with the consequences of resection for colorectal cancer. As treatment options tend to grow, more information on the effects of these treatments is needed to engage in shared decision-making. This study aims to explore the impact of resection for colorectal cancer on patients' daily life. Patients (≥18 years of age) who underwent an oncological colorectal resection between 2018 and 2021 were selected. Purposeful sampling was used to include patients who differed in age, comorbidity conditions, types of (neo)adjuvant therapy, postoperative complications and the presence/absence of a stoma. Semi-structured interviews were conducted, guided by a topic guide. Interviews were fully transcribed and subsequently thematically analysed using the framework approach. Analyses were carried out using the following predefined themes: (1) daily life and activities; (2) psychological functioning; (3) social functioning; (4) sexual functioning; and (5) healthcare experiences. Sixteen patients with a follow-up period of between 0.6 and 4.4 years after surgery were included in this study. Participants reported several challenges experienced because of poor bowel function, a stoma, chemotherapy-induced neuropathy, fear of recurrence and sexual dysfunction. However, they reported these as not interfering much with daily life. Colorectal cancer treatment leads to several challenges and treatment-related health deficits. This is often not recognized by generic patient-reported outcome measures, but the findings on treatment-related health deficits presented in this study contain valuable insights which might contribute to improving colorectal cancer care, shared decision making and value-based health care.

Does EQ-5D Tell the Whole Story? Statistical Methods for Comparing the Thematic Coverage of Clinical and Generic Outcome Measures, With Application to Breast Cancer

ObjectivesThis study aimed to develop the following: (1) methods for assessing claims in any specific application that a generic outcome measure, such as EQ-5D is deficient in its coverage of 1 or more specified domains, and (2) a simple method of judging whether any such deficiency is likely to be quantitatively important enough to call into question evaluations based on the generic instrument. Also to demonstrate the applicability of the methods in the important area of breast cancer. MethodsThe methodology requires a data set with observations from a generic instrument (eg, EQ-5D) and also a more comprehensive clinical instrument (eg, FACT-B [Functional Assessment of Cancer Therapy – Breast]). A standardized 3-component statistical analysis is proposed for investigating the claim that the generic measure inadequately captures some specified dimension covered by the latter instrument. A theoretically based upper bound on the bias induced by deficient coverage is derived based on the assumption that the designers of the (k-dimensional) generic instrument did succeed in identifying the k most important domains. ResultsData from the MARIANNE breast cancer trial were analyzed and results suggested that impacts on personal appearance and relationships may be inadequately represented by EQ-5D. Nevertheless, the indications are that the bias in quality-adjusted life-year differences from deficient coverage by EQ-5D is likely to be modest. ConclusionsThe methodology offers a systematic approach to determining whether there is clear evidence consistent with any claim that a generic outcome measure such as EQ-5D misses an important specific domain. The approach is readily implementable using data sets that are available in many randomized controlled trials.

Patient-reported outcomes and patient-reported outcome measures in liver transplantation: a scoping review.

Generic or condition-specific Patient-reported Outcome Measures (PROMs) are used to measure physical, mental, and social aspects of health to promote patient-centered care. This scoping review aims to identify and summarize generic and condition-specific PRO domains and PROMs that have been assessed and used in liver transplant (LT) candidates and recipients. We searched Medline, Embase, Cochrane Database of Systematic Reviews and Register of Trials, PsychInfo, and CINAHL from inception to 08/26/2020. Included studies addressed a PRO or PROM in LT candidates or recipients. After screening, 341 studies yielded 189 unique PRO domains. Mental health domains (depression, anxiety, and guilt) were most frequently assessed, followed by domains of physical and social health. Fifty-one generic and three condition-specific unique PROMs were identified, with only 13% (n = 45) of studies including condition-specific tools. The most frequent PROMs were the SF-36, Nottingham Health Profile, Hospital Anxiety and Depression Scale, followed by the Liver Disease Quality of Life (LDQoL). Very few studies used transplant-specific PROMs, which may partly be related to the scarcity of LT-specific instruments. We will use these results in future qualitative research to identify PROs and PROMs to build an electronic PROM toolkit to facilitate patient-centered LT care.

Validation of an Adapted Version of the Veterans RAND 12-Item Health Survey for Older Adults Living in Long-Term Care Homes.

The Veterans RAND 12-Item Health Survey (VR-12) is a generic patient-reported outcome measure of physical and mental health status. An adapted version of the VR-12 was developed for use with older adults living in long-term residential care (LTRC) homes in Canada: VR-12 (LTRC-C). This study aimed to evaluate the psychometric validity of the VR-12 (LTRC-C). Data for this validation study were collected via in-person interviews for a province-wide survey of adults living in LTRC homes across British Columbia (N = 8,657). Three analyses were conducted to evaluate validity and reliability: (1) confirmatory factor analyses were conducted to validate the measurement structure; (2) correlations with measures of depression, social engagement, and daily activities were examined to evaluate convergent and discriminant validity; and (3) Cronbach's alpha (r) statistics were obtained to evaluate internal consistency reliability. A measurement model with 2 correlated latent factors (representing physical health and mental health), 4 cross-loadings, and 4 correlated items resulted in an acceptable fit (root-mean-square error of approximation = 0.07; comparative fit index = 0.98). Physical and mental health were correlated in expected directions with measures of depression, social engagement, and daily activities, though the magnitudes of the correlations were quite small. Internal consistency reliability was acceptable for physical and mental health (r > 0.70). This study supports the use of the VR-12 (LTRC-C) to measure perceived physical and mental health among older adults living in LTRC homes.

Abstract P6-05-43: Validity of EQ-5D-5L for women with breast cancer

Abstract Background: The EuroQol- 5 Dimension (EQ-5D) is a generic patient-reported outcome measure widely used to capture meaningful change in health-related quality of life between treatments to inform drug and health technology reimbursement decision making. We investigated the construct validity of EQ-5D-5L in women with breast cancer. Methods: This study included adult women diagnosed with stage I to IV breast cancer, who completed the EQ-5D-5L and the Edmonton Symptom Assessment System (ESAS) during outpatient clinic visits at two academic cancer centres in Toronto. We evaluated construct validity through assessing known-group validity and convergent/divergent validity. For known-group validity, the primary analysis tested the hypothesis that EQ-5D-5L could adequately discriminate between patients with metastatic disease and early-stage disease; secondary analyses addressed utility values between women in breast-cancer associated health states. A suggested minimally important difference (MID) for the Canadian scoring of the EQ-5D-5L is 0.037; we evaluated whether the lower bound of the 95% confidence interval (95%CI) exceeded this value. In terms of convergent/divergent validity, the primary analysis tested the hypothesis that EQ-5D-5L mean utility values for each health state (HS) would be at least moderately correlated with ESAS total symptom distress score (SDS) (|r|&amp;gt;0.30) using Wilcoxon rank-sum tests and Spearman’s correlation tests. Construct validity was considered as acceptable if the hypotheses of the primary analysis are satisfied. Results: We recruited 549 women, 406 (74%) with early-stage disease and 143 (26%) with metastatic disease (HS5), with a mean age of 57 (SD 12); 412 (75%) had been diagnosed with breast cancer in the 7 years prior to recruitment and were receiving active treatment for their cancer. The mean utility value for early-stage breast cancer was 0.84 (95% CI 0.83-0.86) and for metastatic breast cancer (0.78, 95% CI 0.76-0.81). This difference was 0.060 (95% CI 0.036 to 0.085, p&amp;lt; 0.001) with the lower bound of the confidence interval slightly less than the prespecified MID (0.037). There was no significant difference between the mean utility value for women in the first year after primary breast cancer diagnosis (HS1), and women in their second to fifth year after a primary breast cancer treated with curative intent (HS3) or between women in HS1 and women in their sixth and following years after a primary breast cancer treated with curative intent (HS4). EQ-5D-5L also did not discriminate between women in HS3 and HS4. For convergent/divergent validity, there was a negative correlation between utility values and ESAS physical, emotional and total SDSs. EQ-5D-5L and ESAS total SDSs correlation coefficients were higher than 0.30 for all health states. Conclusion: EQ-5D-5L met criteria for convergent/divergent validity in women with breast cancer. The tests for discriminant validity were equivocal, suggesting more research is needed for assessing construct validity with a larger sample size. Table 1. EQ-5D-5L Utility Values. N= number; Std Dev= standard deviation; IQR= interquartile range; CI= confidence interval Citation Format: Sofia Torres, Maureen Trudeau, Geoffrey Liu, Nicholas Mitsakakis, Ahmed Bayoumi. Validity of EQ-5D-5L for women with breast cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-05-43.

Implementation Factors and Their Influence on Student Mathematics Outcomes

Assessing implementation allows for a better understanding of an intervention's effects and the mechanisms that influence its impact. Two main areas of implementation are (a) the quality with which an intervention is delivered and (b) instructors’ adherence to the programmed intervention. The current study used data from a kindergarten mathematics intervention program to (a) examine if and how treatment adherence was associated with implementation quality and (b) explore implementation measures’ relation to student mathematics outcomes. Results indicated high implementation scores across time for both adherence and quality. Neither treatment adherence nor implementation quality was found to relate to a general outcome measure of student mathematics achievement; however, both were similarly related to the curricular–aligned measure.