scholarly journals Validation of a menstrual pictogram and a daily bleeding diary for assessment of uterine fibroid treatment efficacy in clinical studies

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Claudia Haberland ◽  
Anna Filonenko ◽  
Christian Seitz ◽  
Matthias Börner ◽  
Christoph Gerlinger ◽  
...  
Keyword(s):  
Uterine Fibroid ◽  
Full Range ◽  
Intraclass Correlation ◽  
Phase Iii ◽  
Measurement Properties ◽  
Retest Reliability ◽  
Response Options ◽  
Patient Global Impression ◽  
Patient Reported ◽  
Test Retest Reliability

Abstract Background To evaluate the psychometric and measurement properties of two patient-reported outcome instruments, the menstrual pictogram superabsorbent polymer-containing version 3 (MP SAP-c v3) and Uterine Fibroid Daily Bleeding Diary (UF-DBD). Test-retest reliability, criterion, construct validity, responsiveness, missingness and comparability of the MP SAP-c v3 and UF-DBD versus the alkaline hematin (AH) method and a patient global impression of severity (PGI-S) were analyzed in post hoc trial analyses. Results Analyses were based on data from up to 756 patients. The full range of MP SAP-c v3 and UF-DBD response options were used, with score distributions reflecting the cyclic character of the disease. Test-retest reliability of MP SAP-c v3 and UF-DBD scores was supported by acceptable intraclass correlation coefficients when stability was defined by the AH method and Patient Global Impression of Severity (PGI-S) scores (0.80–0.96 and 0.42–0.94, respectively). MP SAP-c v3 and UF-DBD scores demonstrated strong and moderate-to-strong correlations with menstrual blood loss assessed by the AH method. Scores increased in monotonic fashion, with greater disease severities, defined by the AH method and PGI-S scores; differences between groups were mostly statistically significant (P < 0.05). MP SAP-c v3 and UF-DBD were sensitive to changes in disease severity, defined by the AH method and PGI-S. MP SAP-c v3 and UF-DBD showed a lower frequency of missing patient data versus the AH method, and good agreement with the AH method. Conclusions This evidence supports the use of the MP SAP-c v3 and UF-DBD to assess clinical efficacy endpoints in UF phase III studies replacing the AH method.

scholarly journals Cross-cultural translation and validation of the Spanish version of the patellofemoral pain and osteoarthritis subscale of the KOOS (KOOS-PF)

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Juan Pablo Martinez-Cano ◽  
Daniel Vernaza-Obando ◽  
Julián Chica ◽  
Andrés Mauricio Castro
Keyword(s):  
Intraclass Correlation ◽  
Patellofemoral Pain ◽  
Spanish Version ◽  
Minimal Detectable Change ◽  
Global Rating ◽  
Minimal Important Change ◽  
Specific Patient ◽  
Retest Reliability ◽  
Patient Reported ◽  
Test Retest Reliability

Abstract Objective The aim of this study was to translate to Spanish the patellofemoral pain and osteoarthritis subscale of the knee injury and osteoarthritis outcome score (KOOS-PF) and validate this Spanish version of a disease-specific patient-reported outcome measure (PROM) for patellofemoral pain. Results The KOOS-PF was translated to Spanish and sixty patients with patellofemoral pain and/or osteoarthritis accepted to complete the questionnaire. 1-week later 58 patients answered the questions again for the test–retest reliability validation and finally 55 patients completed 1-month later for the responsiveness assessment. The Spanish version showed very good internal consistency (Cronbach’s alpha: 0.93) and test–retest reliability (intraclass correlation coefficient: 0.82). Responsiveness was confirmed, showing a strong correlation with the global rating of change (GROC) score (r 0.64). The minimal detectable change was 11.1 points, the minimal important change was 17.2 points, and there were no floor or ceiling effects for the score.

scholarly journals A reliable and valid measure of COVID-19 patient-reported symptoms in outpatients: the Symptoms Evolution of COVID-19 (SE-C19) instrument

2021 ◽  
Author(s):  
Diana Rofail ◽  
Pip Griffiths ◽  
Giulio Flore ◽  
Mohamed Hussein ◽  
Sumathi Sivapalasingam ◽  
...  
Keyword(s):  
Intraclass Correlation ◽  
Good Test ◽  
Symptom Resolution ◽  
Patient Global Impression ◽  
New Instrument ◽  
Patient Reported ◽  
Item Scores ◽  
Definition Of ◽  
Test Retest Reliability ◽  
Low Prevalence

Background: There is no valid and reliable patient self-reported measure assessing symptomology among outpatients with COVID-19. The Symptoms Evolution of COVID-19 (SE-C19) is a self-administered new instrument that includes 23 symptoms, each rated for severity at their worst moment within the last 24 hours. We studied the psychometric properties of SE-C19. Methods: Reliability, validity, and sensitivity to change of the SE-C19 were assessed in 657 outpatients with confirmed COVID-19 enrolled in NCT04425629. SE-C19 and Patient Global Impression of Severity (PGIS) were administered daily from baseline (predose at Day 1) to end of study (Day 29). Findings: Most patients (70.0%) were aged ≤50 years and white (85.5%). At baseline, patients reported an average (SD) of 6.6 (3.9) symptoms (ie, rated as at least Mild) with 3.8 (3.3) of these symptoms being rated as Moderate or Severe. By Day 29, most symptoms had resolved; 74.4% of patients reported no symptoms and on average, only 0.6 (SD 1.5) were reported as at least Mild. Stable patients according to the PGIS showed scores with intraclass correlation values indicating moderate-to-good test-retest reliability (ie, 0.50-0.90). At baseline, 20 item scores (87%) varied significantly across PGIS defined groups supporting the validity of SE-C19. A symptom resolution endpoint was defined after excluding the item 'Sneezing', due to its low ability to discriminate severity levels, and 'Confusion', 'Rash', and 'Vomiting', due to their low prevalence in this population. Symptoms resolution required complete absence of all remaining items, except 'Cough', 'Fatigue', and 'Headache', which could be Mild or Moderate in severity. Interpretation: We identified 19 items that are valid and reliable to measure disease-related symptoms in COVID-19 outpatients and propose a definition of symptom resolution that could be used in future clinical trials and potentially, also in clinical practice.

scholarly journals Cross-Cultural Adaptation, Translation, and Validation of the Toronto Extremity Salvage Score for Extremity Bone and Soft Tissue Tumor Patients in Netherlands

Sarcoma ◽  
2017 ◽  
Vol 2017 ◽  
pp. 1-6 ◽  
Author(s):  
Julie J. Willeumier ◽  
C. W. P. G. van der Wal ◽  
Robert J. P. van der Wal ◽  
P. D. S. Dijkstra ◽  
Thea P. M. Vliet Vlieland ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Physical Function ◽  
Short Form ◽  
Intraclass Correlation ◽  
Retest Reliability ◽  
Sf 36 ◽  
Toronto Extremity Salvage Score ◽  
Patient Reported ◽  
Test Retest Reliability ◽  
Extremity Salvage

Purpose. The aim of this study was to translate and culturally adapt the Toronto Extremity Salvage Score (TESS) to Dutch and to validate the translated version. Methods. The TESS lower and upper extremity versions (LE and UE) were translated to Dutch according to international guidelines. The translated version was validated in 98 patients with surgically treated bone or soft tissue tumors of the LE or UE. To assess test-retest reliability, participants were asked to fill in a second questionnaire after one week. Construct validity was determined by computing Spearman rank correlations with the Short Form- (SF-) 36. Results. The internal consistency (0.957 and 0.938 for LE and UE, resp.) and test-retest reliability (intraclass correlation coefficients 0.963 and 0.969 for LE and UE, resp.) were good for both questionnaires. The Dutch LE and UE TESS versions correlated most strongly with the SF-36 physical function dimension (r=0.737 for LE, 0.726 for UE) and the physical component summary score (r=0.811 and 0.797 for LE and UE). Interpretation. The Dutch TESS questionnaire for lower and upper extremities is a consistent, reliable, and valid instrument to measure patient-reported physical function in surgically treated patients with a soft tissue or bone tumor.

scholarly journals Patient Preference Assessment Reveals Disease Aspects Not Covered by Recommended Outcomes in Polymyositis and Dermatomyositis

2011 ◽  
Vol 2011 ◽  
pp. 1-5 ◽  
Author(s):  
Li Alemo Munters ◽  
Ronald F. van Vollenhoven ◽  
Helene Alexanderson
Keyword(s):  
Patient Preference ◽  
Intraclass Correlation ◽  
Health Assessment ◽  
Preference Assessment ◽  
Weighted Kappa ◽  
Measurement Properties ◽  
Retest Reliability ◽  
Related Quality ◽  
Health Related ◽  
Test Retest Reliability

Objectives. Polymyositis (PM) and dermatomyositis (DM) are characterized by impaired muscle function with a majority of patients developing sustained disability. The aim of this study was to evaluate the patient’s individual priorities (patient preference) of disabilities most important to improve in PM/DM using the MacMaster Toronto Arthritis Patient Preference Disability Questionnaire (MACTAR), to correlate the MACTAR to myositis outcomes and to evaluate its test-retest reliability. Methods. Twenty-eight patients with PM/DM performed recommended outcomes as well as the MACTAR, which was performed twice with one week apart. Results. Sexual activity, walking, biking, social activities, and sleep constituted the predominating disabilities. Seventy-two and 33% of the identified disabilities were not covered by items of the Health Assessment Questionnaire and the Myositis Activities Profile. Correlations between the MACTAR and health-related quality of life measures were = −0.67–0.73, correlations with measures of activities of daily living and participation in society were = 0.51–0.60 with lower correlations for other outcomes. Intraclass correlation (ICC) and weighted Kappa () coefficients were 0.83 and 0.68, respectively, for test-retest reliability of the MACTAR. Conclusions. The MACTAR interview had promising measurement properties and identified patient preference disabilities in PM/DM that were not covered by recommended outcomes.

scholarly journals Allodynography: Reliability of a New Procedure for Objective Clinical Examination of Static Mechanical Allodynia

Pain Medicine ◽  
2019 ◽  
Vol 21 (1) ◽  
pp. 101-108
Author(s):  
Tara L Packham ◽  
Claude J Spicher ◽  
Joy C MacDermid ◽  
Norman D Buckley
Keyword(s):  
Clinical Examination ◽  
Clinical Assessment ◽  
Mechanical Allodynia ◽  
Intraclass Correlation ◽  
Assessment Tools ◽  
Measurement Properties ◽  
Rater Reliability ◽  
Retest Reliability ◽  
Static Mechanical ◽  
Test Retest Reliability

Abstract Objective There is a need for reliable and valid clinical assessment tools for quantifying allodynia in neuropathic pain. Allodynography has been proposed as a useful standardized procedure for clinical assessment of mechanical allodynia. This study (www.clinicaltrials.gov NCT02070367) undertook preliminary investigation of the measurement properties of allodynography, a new standardized clinical examination procedure for mapping the area of cutaneous allodynia. Methods Persons with pain in one upper extremity after complex regional pain syndrome, a peripheral nerve injury, or who had recently experienced a hand fracture were recruited for assessment of static mechanical allodynia (based on perception of a 15g force stimulus delivered by Semmes-Weinstein monofilament #5.18 as painful) by two raters at baseline; the assessment was repeated one week later. Results Single-measures estimates suggested inter-rater reliability for allodynography was excellent at an intraclass correlation coefficient (ICC) of 0.97 (N = 12); test–retest reliability was also excellent at ICC = 0.89 (N = 10) for allodynography (P &lt; 0.001 for both). Confidence intervals’ lower bounds confirm inter-rater reliability as excellent (0.90) but were less definitive for test–retest (0.59). Conclusions This preliminary study supports the inter-rater and test–retest reliability of allodynography. Studies on larger samples in multiple contexts and reporting other measurement properties are warranted.

Cross-Cultural Adaptation and Measurement Properties of the Italian Version of the Patient-Rated Tennis Elbow Evaluation (PRTEE) Questionnaire

2012 ◽  
Vol 92 (8) ◽  
pp. 1036-1045 ◽  
Author(s):  
Angelo Cacchio ◽  
Stefano Necozione ◽  
Joy C. MacDermid ◽  
Jan Dirk Rompe ◽  
Nicola Maffulli ◽  
...  
Keyword(s):  
Internal Consistency ◽  
Convergent Validity ◽  
Tennis Elbow ◽  
Small Sample Size ◽  
Intraclass Correlation ◽  
Small Sample ◽  
Measurement Properties ◽  
Italian Version ◽  
Retest Reliability ◽  
Test Retest Reliability

Background The Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire is a tool designed for self-assessment of forearm pain and disability in patients with lateral elbow tendinopathy (LET). However, an Italian version of this questionnaire has not been available. Objective The aims of this study were: (1) to translate and cross-culturally adapt the PRTEE questionnaire into Italian and (2) to evaluate its measurement properties. Design This was a longitudinal, observational measurement study. Methods The PRTEE questionnaire was cross-culturally adapted to Italian according to established guidelines. Ninety-five individuals (41 women, 54 men) with unilateral, imaging-confirmed, chronic LET were selected consecutively to assess the measurement properties of the PRTEE questionnaire. Internal consistency, test-retest reliability, construct validity, and responsiveness were estimated. Results The Italian version of the PRTEE displayed a high degree of internal consistency, with a Cronbach alpha of .95. The test-retest reliability was high for both short-term and medium-term, with intraclass correlation coefficients (2,1) of .95 and .93, respectively. The PRTEE exhibited a strong correlation (r=.77–.91, P&lt;.0001) with the Disabilities of the Arm, Shoulder and Hand (DASH) at the baseline and a moderate correlation (r=.58–.74, P&lt;.0001) at discharge. The responsiveness was higher for the PRTEE than for the DASH. Limitations A methodological limitation of the study is that due to the small sample size, a factor analysis was not performed to assess convergent validity. Conclusions The Italian version of the PRTEE questionnaire is internally consistent, demonstrates expected correlations with other measures, and is more responsive than the DASH in Italian patients with chronic LET.

Validity and reliability of the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9047-9047 ◽  
Author(s):  
Amylou C. Dueck ◽  
Tito R. Mendoza ◽  
Sandra A. Mitchell ◽  
Bryce B. Reeve ◽  
Kathleen M. Castro ◽  
...  
Keyword(s):  
Adverse Events ◽  
Patient Reported Outcomes ◽  
Performance Status ◽  
Intraclass Correlation ◽  
Validity And Reliability ◽  
Retest Reliability ◽  
Cancer Centers ◽  
Patient Reported ◽  
Ecog Ps ◽  
Test Retest Reliability

9047 Background: Symptomatic adverse events (AE) in cancer trials are reported by clinicians using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE). To integrate the patient perspective into AE reporting, NCI contracted (HHSN261201000043C) to create a patient-reported outcomes companion tool (PRO-CTCAE). We report the validity and reliability of PRO-CTCAE’s 124 items reflecting 78 symptomatic AEs. Methods: English-speaking subjects (n=869; 44% male; median [mdn] age 59; 32% racial/ethnic minority; 34% high school or less; 17% ECOG Performance Status [PS] 2-4) receiving treatment for a range of cancers at 4 NCI-designated cancer centers and 5 sites in NCI's Community Cancer Centers Program completed a web-based survey in clinic including PRO-CTCAE and EORTC QLQ-C30. Pearson correlations were computed between PRO-CTCAE items and QLQ-C30 scales. Differences in PRO-CTCAE item scores between clinician-reported ECOG PS (0-1 vs 2-4) groups were computed. Test-retest reliability of 48 prespecified items was evaluated in a subset (n=79). Results: Correlations in the expected direction were observed for 116/124 PRO-CTCAE items with the QLQ-C30 global health scale (mdn r=-.21; range .08 to -.57). Stronger correlations were seen for PRO-CTCAE items with conceptually related QLQ-C30 domains: fatigue with physical, role and social functioning (-.54 to -.66); anxiety and depression with emotional functioning (-.54 to -.70); and concentration and memory problems with cognitive functioning (-.62 to -.72) [all p <0.001]. Fatigue, nausea, vomiting, pain, dyspnea, insomnia, appetite loss, constipation and diarrhea items strongly correlated with corresponding QLQ-C30 symptom scales (.69 to .79, all p <0.001). Scores for 98/124 PRO-CTCAE items were higher in the ECOG PS 2-4 vs 0-1 group (mdn effect size .3). Test-retest reliability was observed across all tested items (mdn intraclass correlation coeff .77; range .53 to .96). Conclusions: Results demonstrate favorable validity and reliability of PRO-CTCAE in a large, heterogeneous sample of patients undergoing cancer treatment. Further testing in multicenter treatment trials is underway.

scholarly journals Measurement properties of the Dynavision D2 one-minute drill task in active adolescents

Neurology ◽  
2018 ◽  
Vol 91 (23 Supplement 1) ◽  
pp. S4.2-S4
Author(s):  
Tamara McLeod ◽  
R. Curtis Bay ◽  
Hannah Gray ◽  
Richelle Marie Williams
Keyword(s):  
Repeated Measures ◽  
Intraclass Correlation ◽  
Correlation Coefficients ◽  
Practice Effect ◽  
Practice Effects ◽  
Measurement Properties ◽  
Post Injury ◽  
Retest Reliability ◽  
The One ◽  
Test Retest Reliability

ObjectiveThe purpose of this study was to evaluate test-retest reliability and practice effects of the Dynavision D2 in active adolescents.BackgroundFollowing sport-related concussion, assessment of oculomotor function and vision is important. While clinical tests are recommended, computerized devices, such as the Dynavision D2, are emerging as viable tools for vision assessment. As with all concussion assessments, understanding test-retest reliability and susceptibility to practice effects is important for appropriate interpretation of serial assessments post-injury.Design/methodsParticipants included 20 female adolescents (age = 16.6 ± 1.10 years, mass = 62.0 ± 5.9 kg, height = 169.2 ± 5.1 cm). Participants completed 2 test sessions 1 week apart using the Dynavision D2. The Dynavision D2 includes a one-minute drill task where a single light illuminates, and participants hit the light as quickly as possible, completing 3 drills per trial. Participants completed 3 trials during the first session and 2 during the second. Independent variables were day (day 1, day 2) and drills (15 drills). Dependent variables were the number of hits per minute (Hits/min) and average reaction time (AvgRT). Within-day and between-day test-retest reliabilities were analyzed using two-way random effects intraclass correlation coefficients for consistency. Practice effects were analyzed with repeated measures analysis of variance and Helmert contrasts (p = 0=.05).ResultsModerate-to-strong reliability was demonstrated for Hits/min (within-day 1 [ICC = 0.74; 95% CI: 0.53, 0.87]; within-day 2 [ICC = 0.91; 95% CI. 77.97]; between-days [ICC = 0.86; 95% CI. 65.95]). Moderate-to-strong reliability was demonstrated for AvgRT (within-day 1 [ICC = 0.70, 95% CI. 48.86], within-day 2 [ICC = 0.92; 95% CI. 78.97]; between-days [ICC = 0.85; 95% CI: 0.64.94]). Practice effects were noted for Hits/Min (p = 0.001) and AvgRT (p < 0.001). Helmert contrasts suggested that the practice effect plateaued at drill 11 for Hits/min and drill 12 for AvgRT.ConclusionsModerate-to-excellent test-retest reliability was found for the one-minute task drill with better reliability noted on day 2 and between days, compared to day 1. This task is susceptible to practice effects, highlighting the need for familiarization or practice trials prior to documenting patient scores.

Validation of the Chinese Version of Family-Professional Partnership Scale in Early Intervention

2020 ◽  
Vol 42 (4) ◽  
pp. 381-395
Author(s):  
Lin-Ju Kang ◽  
Yu-Wei Hsu ◽  
Ai-Wen Hwang
Keyword(s):  
Early Intervention ◽  
Construct Validity ◽  
Internal Consistency ◽  
Intraclass Correlation ◽  
Chinese Version ◽  
Measurement Properties ◽  
Retest Reliability ◽  
The Family ◽  
Test Retest Reliability ◽  
Family Centered

The Chinese version of the Family-Professional Partnership Scale (FPPS-C) measures satisfaction with mutually established parent-professional partnerships. This study aimed to evaluate the measurement properties of the FPPS-C Family and Professional Versions. The participants comprised 167 parents who had a child enrolled in an early intervention program, and 200 early intervention professionals in Taiwan. Structural validity, internal consistency, test–retest reliability, and construct validity were examined. The Family Version denoted a single-dimensional scale with high internal consistency (α = .99) and adequate test–retest reliability (intraclass correlation coefficient [ICC] = 0.54). The Professional Version showed a three-factor structure with moderate to adequate internal consistency (α = .64–.90) and test–retest reliabilities (ICC = 0.60–0.77). Construct validity was evidenced through positive associations between parental and professional perceptions on partnerships and to family-centered service provision. The FPPS-C is a reliable and valid measure, and the study findings can influence research initiatives and practices that aim to ameliorate the provision of family-centered services by early intervention programs.

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