Dataset Information

Interpreting Patient Reported Urinary and Sexual Function Outcomes across Multiple Validated Instruments.

ABSTRACT: PURPOSE:Comparing patient reported outcomes such as urinary and erectile function across institutions is critical for prostate cancer research and quality assurance. Such comparisons are complicated due to the use of different questionnaires. We aimed to develop a method to convert scores among 4 commonly used instruments. MATERIALS AND METHODS:Patient reported data on urinary and sexual function were collected on 1,284 men with localized prostate cancer using the EPIC-26 (Expanded Prostate Index Composite), PCI (UCLA Prostate Cancer Index), SHIM (Sexual Health Inventory for Men) and I-PSS (International Prostate Symptom Scale) questionnaires. We investigated several methods to convert scores among questionnaires. RESULTS:Conversion between EPIC and PCI urinary and sexual function subscales was best achieved using only the subset of questions asked on both questionnaires. For the conversion between EPIC or PCI erectile function scores and SHIM scores, we defined thresholds of poor, intermediate and good function as EPIC/PCI 0 to 40 and SHIM 1 to 7, EPIC/PCI 41 to 59 and SHIM 8 to 16, and EPIC/PCI 60 to 100 and SHIM 17 to 25, respectively. Urinary continence scores highly correlated for PCI and EPIC (r = 0.94). No comparison was possible for I-PSS with EPIC and PCI due to differences in the domains addressed by these questionnaires. CONCLUSIONS:We have introduced methods to convert scores among the EPIC, PCI and SHIM questionnaires. While these conversion methods may introduce minor imprecision, to our knowledge they represent the best available tools to combine and compare patient reported outcomes that are assessed using different instruments in men undergoing radical prostatectomy or active surveillance.

SUBMITTER: Vertosick EA

PROVIDER: S-EPMC5636214 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Interpreting Patient Reported Urinary and Sexual Function Outcomes across Multiple Validated Instruments.

Vertosick Emily A EA Vickers Andrew J AJ Cowan Janet E JE Broering Jeanette M JM Carroll Peter R PR Cooperberg Matthew R MR

The Journal of urology 20170322 3

<h4>Purpose</h4>Comparing patient reported outcomes such as urinary and erectile function across institutions is critical for prostate cancer research and quality assurance. Such comparisons are complicated due to the use of different questionnaires. We aimed to develop a method to convert scores among 4 commonly used instruments.<h4>Materials and methods</h4>Patient reported data on urinary and sexual function were collected on 1,284 men with localized prostate cancer using the EPIC-26 (Expande ...[more]

PMID: 28342935

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Project description:BACKGROUND:Patient-reported outcome measures (PROMs) have become widely adopted in the care of patients with prostate cancer, but there is no validated crosswalk between two commonly used instruments, the Expanded Prostate Cancer Index Composite Short Form (EPIC-26) and the Memorial Sloan Kettering (MSK) instrument, which consists of the International Index of Erectile Function-6 (IIEF-6) questionnaire and the MSK radical prostatectomy urinary outcome scale. OBJECTIVE:To develop and validate bidirectional crosswalks between the sexual and urinary domains (single domain in MSK, separate incontinence and irritative/obstructive domains in EPIC-26) of the MSK and EPIC-26 instruments. DESIGN, SETTING, AND PARTICIPANTS:Radical prostatectomy (RP) patients completing instruments at MSK and Michigan Urological Surgery Improvement Collaborative (MUSIC) between January and May of 2017 were invited to enroll. Stratified random sampling (by institution, MSK urinary function score, and MSK erectile function score) was used to divide patient data into training and test sets. Models were developed to predict the domain score for each instrument using the other's item responses and domain scores. Performance was evaluated using capped root-mean-squared error and accuracy at established thresholds. RESULTS AND LIMITATIONS:We received 517 instruments at MSK and 1033 within MUSIC, which were assigned to training (825), post-RP test (412), and pre-RP test (313) sets. We found the crosswalks to have low error and high accuracy. Although the crosswalks are more accurate if responses to each item are known, it is possible to convert between instruments on the basis of a total domain score. CONCLUSIONS:The crosswalks are a valid way to convert between sexual and urinary domains of the MSK and EPIC-26 instruments. PATIENT SUMMARY:We developed and validated a set of formulas that allow conversion of sexual and urinary function scores between the Memorial Sloan Kettering and Expanded Prostate Cancer Index Composite Short Form patient-reported outcome questionnaires. These crosswalks allow seamless transition between the two questionnaires.

Project description:PURPOSE:Accurately tracking health-related quality-of-life after radical prostatectomy is critical to counseling patients and improving technique. Physicians consistently overestimate functional recovery. We measured concordance between surgeon-assessed and patient-reported outcomes and evaluated a novel method to provide feedback to surgeons. MATERIALS AND METHODS:Men treated with radical prostatectomy self-completed the International Index of Erectile Function-6 questionnaire at each postoperative visit. Separately, physicians graded sexual function on a 5-point scale. International Index of Erectile Function -6 score<22 and grade ?3 defined patient-reported and physician-assessed erectile dysfunction (ED), respectively. Feedback on concordance was given to physicians starting in May 2013 with the implementation of the Amplio feedback system. Chi-square tests were used to assess agreement proportions and linear regression to evaluate changes in agreement after implementation. RESULTS:From 2009 to 2015, 3,053 men completed at least 1 postprostatectomy questionnaire and had a concurrent independent physician-reported outcome. Prior to implementation of feedback in 2013, patients and physicians were consistent as to ED 83% of the time; in 10% of cases, physicians overestimated function; in 7% of cases, physicians, but not patients reported ED. Agreement increased after implementation of feedback but this was not statistically significant, likely owing to a ceiling effect. Supporting this hypothesis, increase in agreement postfeedback was greater during late follow-up (?12mo), where baseline agreement was lower compared to earlier follow-up. CONCLUSIONS:Agreement was higher than expected at baseline; implementation of feedback regarding discrepancies between patient-reported and physician-assessed outcomes did not further improve agreement significantly. Our observed high rate of agreement may be partly attributed to our institutional practice of systematically capturing patient-reported outcomes as part of normal clinical care.

Project description:ObjectivesWe (1) collected instruments that assess health-related quality of life (HRQoL), activities of daily living (ADL) and social participation during follow-up after polytrauma, (2) described their use and (3) investigated other relevant patient-reported outcomes (PROs) assessed in the studies.DesignSystematic Review using the Preferred Reporting Items for Systematic Review and Meta-Analysis guideline.Data sourcesMEDLINE, Embase, CINAHL, PsycINFO, CENTRAL, as well as the trials registers ClinicalTrials.gov and WHO ICTRP were searched from January 2005 to April 2018.Eligibility criteriaAll original empirical research published in English or German including PROs of patients aged 18-75 years with an Injury Severity Score≥16 and/or an Abbreviated Injury Scale≥3. Studies with defined injuries or diseases (e.g. low-energy injuries) and some text types (e.g. grey literature and books) were excluded. Systematic reviews and meta-analyses were excluded, but references screened for appropriate studies.Data extraction and synthesisData extraction, narrative content analysis and a critical appraisal (e.g. UK National Institute for Health and Care Excellence) were performed by two reviewers independently.ResultsThe search yielded 3496 hits; 54 publications were included. Predominantly, HRQoL was assessed, with Short Form-36 Health Survey applied most frequently. ADL and (social) participation were rarely assessed. The methods most used were postal surveys and single assessments of PROs, with a follow-up period of one to one and a half years. Other relevant PRO areas reported were function, mental disorders and pain.ConclusionsThere is a large variation in the assessment of PROs after polytrauma, impairing comparability of outcomes. First efforts to standardise the collection of PROs have been initiated, but require further harmonisation between central players. Additional knowledge on rarely reported PRO areas (e.g. (social) participation, social networks) may lead to their consideration in health services provision.Prospero registration numberCRD42017060825.

Project description:To present the baseline patient-reported outcome measures (PROMs) in the Prostate Testing for Cancer and Treatment (ProtecT) randomized trial comparing active monitoring, radical prostatectomy and external-beam conformal radiotherapy for localized prostate cancer and to compare results with other populations.A total of 1643 randomized men, aged 50-69 years and diagnosed with clinically localized disease identified by prostate-specific antigen (PSA) testing, in nine UK cities in the period 1999-2009 were included. Validated PROMs for disease-specific (urinary, bowel and sexual function) and condition-specific impact on quality of life (Expanded Prostate Index Composite [EPIC], 2005 onwards; International Consultation on Incontinence Questionnaire-Urinary Incontinence [ICIQ-UI], 2001 onwards; the International Continence Society short-form male survey [ICSmaleSF]; anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), generic mental and physical health (12-item short-form health survey [SF-12]; EuroQol quality-of-life survey, the EQ-5D-3L) were assessed at prostate biopsy clinics before randomization. Descriptive statistics are presented by treatment allocation and by men's age at biopsy and PSA testing time points for selected measures.A total of 1438 participants completed biopsy questionnaires (88%) and 77-88% of these were analysed for individual PROMs. Fewer than 1% of participants were using pads daily (5/754). Storage lower urinary tract symptoms were frequent (e.g. nocturia 22%, 312/1423). Bowel symptoms were rare, except for loose stools (16%, 118/754). One third of participants reported erectile dysfunction (241/735) and for 16% (118/731) this was a moderate or large problem. Depression was infrequent (80/1399, 6%) but 20% of participants (278/1403) reported anxiety. Sexual function and bother were markedly worse in older men (65-70 years), whilst urinary bother and physical health were somewhat worse than in younger men (49-54 years, all P < 0.001). Bowel health, urinary function and depression were unaltered by age, whilst mental health and anxiety were better in older men (P < 0.001). Only minor differences existed in mental or physical health, anxiety and depression between PSA testing and biopsy assessments.The ProtecT trial baseline PROMs response rates were high. Symptom frequencies and generic quality of life were similar to those observed in populations screened for prostate cancer and control subjects without cancer.

Project description:BackgroundThe PRIMUS is a Multiple Sclerosis (MS)-specific suite of outcome measures including assessments of QoL (PRIMUS QoL, scored 0-22) and activity limitations (PRIMUS Activities, scored 0-30). The U-FIS is a measure of fatigue impact (scored 0-66). These measures have been fully validated previously using an MS sample with mixed diagnoses. The aim of the present study was to validate the measures further in a specifically Relapse Remitting MS (RRMS) sample and to provide preliminary evidence of the responder definitions (RD; also known as minimal important difference) for these instruments.MethodsData were derived from a multi-country efficacy trial of MS patients with assessments at baseline and 12 months. Baseline data were used to assess the internal reliability and validity of the measures. Both anchor-based and distribution-based approaches were employed for estimating RD. Anchor-based estimates were based on published RD values for the EQ-5D and were assessed for those improving and deteriorating separately. Distribution-based estimates were based on standard error of measurement (SEM), change score equivalent to 0.30, and change score equivalent to 0.50, effect sizes (ES).ResultsThe sample included 911 RRMS patients (67.3% female, age mean (SD) 36.2 (8.4) years, duration of MS mean (SD) 4.8 (5.2) years). Results showed that the PRIMUS and U-FIS had good internal consistency. Appropriate correlations were observed with comparator instruments and both measures were able to distinguish between participants based on Expanded Disability Status Scale scores and time since diagnosis. The anchor-based and distribution-based RD estimates were: PRIMUS Activities range = 1.2-2.3, PRIMUS QoL range = 1.0-2.2, and U-FIS range = 2.4-7.0.ConclusionsThe results show that the PRIMUS and U-FIS are valid instruments for use with RRMS patients. The analyses provide preliminary information on how to interpret scores on the scales. These data will be useful for assessing treatment efficacy and for powering clinical studies. TRIAL REFERENCE NUMBER: ClinicalTrials.gov Identifier NCT00340834.

Project description:BackgroundLimitations in physical functioning are a big concern especially for patients with chronic or musculoskeletal diseases. Therefore, physical functioning is often used as a core outcome of treatments. The generic patient-reported outcomes information system (PROMIS) physical function (PF) item bank has shown potential to measure PF with better precision, interpretability and lower respondent burden compared with traditional patient-reported outcome measures. This study provides an overview of the current evidence on the quality of the measurement properties of the translated Dutch-Flemish PROMIS-PF item bank and its subdomains, and their derived short forms and computer adaptive tests (CATs).MethodsPubMed was searched up to June 17th 2020 for validation studies of Dutch-Flemish PROMIS-PF in Dutch and Flemish adults. Quality assessment of the included studies was conducted using the COSMIN Risk of bias checklist. The COSMIN criteria for good measurement properties were used to judge the results of the studies, which were adjusted and added to where needed for this review, in the context of IRT instruments and item banks. The quality of evidence was summarized for each measurement property based on the Grading of Recommendation Assessment, Development, and Evaluation (GRADE) approach.ResultsEleven studies were included, evaluating the PROMIS-PF item bank, the Upper Extremity (UE) subdomain, and/or their derived short forms and CATs in different clinical populations. There is evidence for sufficient structural validity, measurement precision, construct validity, and cross-cultural validity of the Dutch-Flemish PROMIS-PF item bank. The upper extremity subdomain item bank shows high quality evidence for structural validity and measurement precision. Content validity of these item banks has not been thoroughly demonstrated in a Dutch-Flemish population. Furthermore, the derived instruments have far less robust evidence: there are fewer validation studies available and none examined their performance as stand-alone administered instruments.ConclusionsThe first studies into the Dutch-Flemish PROMIS-PF item bank and the UE subdomain show promising results, with especially high quality evidence for sufficient structural validity and measurement precision. However, more studies, and with higher methodological quality, are needed to study the instruments derived from these item banks. These studies should also evaluate content validity, reliability and responsiveness.

Dataset Information

Interpreting Patient Reported Urinary and Sexual Function Outcomes across Multiple Validated Instruments.

Publications

Interpreting Patient Reported Urinary and Sexual Function Outcomes across Multiple Validated Instruments.

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