Novel patient-specific visual analogue survey (PVS) is validated in patients treated with collagenase injection for Dupuytren’s disease

2019 ◽  
Vol 5 (1) ◽  
pp. 3-9
Author(s):  
Stephen L Lyman ◽  
Jayme Burket Kotsov ◽  
Chisa Hidaka ◽  
Quynh Tran ◽  
Naomi Roselaar ◽  
...  
Keyword(s):  
Effect Size ◽  
External Validation ◽  
Patient Specific ◽  
Dupuytren’S Contracture ◽  
Post Injection ◽  
Retest Reliability ◽  
Dupuytren's Contracture ◽  
Number Of Patients ◽  
Patient Reported ◽  
Test Retest Reliability

ObjectivesWe developed and validated an electronically administered patient-specific visual analogue survey (PVS) to evaluate changes in hand function after treatment with injectable collagenase clostridium histolyticum (CCH) in Dupuytren’s contracture. The items in the PVS were authored and ranked in importance by the patients.MethodsIn an open-label trial for patients with Dupuytren’s contracture receiving CCH injection, 109 patients completed the PVS on the day of injection, day of manipulation and 30-day follow-up. For external validation, patients also completed standard patient-reported outcome measures, the Overall Treatment Effects Scale and QuickDASH, and underwent physician assessment of contracture via goniometry and the table top test.ResultsResponses were highly individualised with no single activity being chosen as important by more than 8% of patients. Sports-related activities were mentioned most often (23%). The PVS was highly responsive to changes in patients’ conditions with CCH injection (effect size=1.49), much more so than the QuickDASH (effect size=0.50). Additionally, the PVS had no floor or ceiling effects, whereas the QuickDASH ceiling approached 20% post-injection. The PVS had excellent internal consistency (Cronbach’s α=0.95) and correlated strongly with the QuickDASH post-injection (Spearman’s=−0.67). PVS scores were significantly higher for patients reporting their condition had improved versus those reporting no change after injection. The test–retest reliability of the PVS was poor to fair, in part due to allowing patients to choose different activities at test and retest. However, test–retest reliability was good (intraclass correlation coefficient >0.7) and better than QuickDASH among patients who rated the same activities at test and retest.ConclusionsThe PVS is simple to administer and enables individualised assessment in a large number of patients. It is also readily adaptable for use in other diseases, particularly within musculoskeletal medicine.Level of evidenceTherapeutic II: Prospective cohort.

Reliability, Validity and Responsiveness of Physical Activity Monitors in Patients with Inflammatory Myopathy

Rheumatology ◽  
2021 ◽  
Author(s):  
Bonny Rockette-Wagner ◽  
Didem Saygin ◽  
Siamak Moghadam-Kia ◽  
Chester Oddis ◽  
Océane Landon-Cardinal ◽  
...  
Keyword(s):  
Physical Activity ◽  
Construct Validity ◽  
Disease Activity ◽  
Retest Reliability ◽  
Activity Monitors ◽  
Muscle Testing ◽  
Patient Reported ◽  
Physical Activity Monitors ◽  
Global Disease Activity ◽  
Test Retest Reliability

Abstract Objective Idiopathic inflammatory myopathies (IIM) cause proximal muscle weakness, which affect activities of daily living. Wearable physical activity monitors (PAMs) objectively assess continuous activity with potential clinical usefulness in IIM assessment. We examined the psychometric characteristics for PAM outcomes in IIM. Methods Adult IIM patients were prospectively evaluated (baseline, 3 and 6-months) in an observational study. A waist-worn PAM (ActiGraph GT3X-BT) assessed average step counts/min, peak 1-min cadence, and vector magnitude/min. Validated myositis core set measures (CSM) including manual muscle testing (MMT), physician global disease activity (MD global), patient global disease activity (Pt global), extra-muscular disease activity (Ex-muscular global), HAQ-DI, muscle enzymes, and patient-reported physical function were evaluated. Test-retest reliability, construct validity, and responsiveness were determined for PAM measures and CSM using Pearson correlations and other appropriate analyses. Results 50 adult IIM patients enrolled [mean (SD) age, 53.6 (±14.6); 60% female, 94% Caucasian]. PAM measures showed strong test-retest reliability, moderate-to-strong correlations at baseline with MD global (r=-0.37- -0.48), Pt-global (r=-0.43- -0.61), HAQ-DI (r=-0.47- -0.59) and MMT (r = 0.37–0.52), and strong discriminant validity for categorical MMT and HAQ-DI. Longitudinal association with MD global (r=-0.38- -0.44), MMT (r = 0.50–0.57), HAQ-DI (r=-0.45- -0.55), and functional tests (r = 0.30–0.65) were moderate-to-strong. PAM measures were responsive to MMT improvement (≥10%) and moderate-to-major improvement on ACR/EULAR myositis response criteria. Peak 1-min cadence had the largest effect size and Standardized Response Means (SRMs). Conclusion PAM measures showed promising construct validity, reliability, and longitudinal responsiveness; especially peak 1-min cadence. PAMs provide valid outcome measures for future use in IIM clinical trials.

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.

Validation of a Handprint for Clinical Evaluation of Dupuytren’s Contracture

2021 ◽  
Author(s):  
Takashi Ajiki ◽  
Akira Murayama ◽  
Yukinori Hayashi ◽  
Katsushi Takeshita
Keyword(s):  
Clinical Evaluation ◽  
High Reliability ◽  
Flexion Contracture ◽  
Dupuytren’S Contracture ◽  
Therapeutic Effects ◽  
Level Of Evidence ◽  
Dupuytren's Contracture ◽  
Palmar Surface ◽  
Patient Reported ◽  
Quick Dash

Abstract Objective We have developed a handprint-based method for visualizing and quantifying the palmar contact of patients with Dupuytren’s contracture. The purpose of this study was to examine whether the generated handprint was useful for assessing the severity of flexion contracture of the fingers and for evaluating the therapeutic effects of collagenase clostridium histolyticum (CCH) injection for Dupuytren’s contracture. Methods The handprint was created by applying medical-grade ethanol-containing hand sanitizer over the entire palmar surface of the affected hand and then pressing it on thermal paper for word processors. The reliability of the handprint was evaluated through test–retest of 10 healthy volunteers at an interval of 10 days, and the validity of the handprint was assessed using a flexion contracture model in which the little finger was fixed in an Alfence splint. In addition, we obtained handprints of the affected hand in 33 patients with unilateral Dupuytren’s contracture both before CCH injection and at the final observation after injection to investigate the contact area of the hand (CAH) and the length of the hand (LH). The relationships between CAH, LH, total extension deficit angle (TEDA), and patient-reported outcome measures (Japanese Society for Surgery of the Hand Version of the Quick Disability of Arm, Shoulder, and Hand Questionnaire [Quick DASH-JSSH] and Hand20) were examined. Results The test–retest correlation coefficient was 0.9187 (p < 0.001) for CAH and 0.9052 (p < 0.001) for LH, indicating high reliability of the handprint. The ratios of CAH and LH decreased gradually as the contracture angle of the splinted finger increased. The handprint revealed a marked improvement of palmar contact after CCH injection for Dupuytren’s contracture. Furthermore, the ratios of CAH and LH were strongly correlated with TEDA, Quick DASH-JSSH, and Hand20 before treatment. Conclusion Our handprint-based assessment method was extremely useful for clinical evaluation of CCH treatment for Dupuytren’s contracture. Type of Study/Level of Evidence Therapeutic.

External Validation and Test-Retest Reliability of Postpartum Bonding Questionnaire in Spanish Mothers

2021 ◽  
Vol 24 ◽  
Author(s):  
Anna Torres-Giménez ◽  
Alba Roca-Lecumberri ◽  
Bàrbara Sureda ◽  
Susana Andrés-Perpiña ◽  
Bruma Palacios-Hernández ◽  
...  
Keyword(s):  
Mental Health ◽  
Maternal Mental Health ◽  
Characteristic Curve ◽  
External Validation ◽  
Area Under The Curve ◽  
Retest Reliability ◽  
Outpatient Unit ◽  
Auc Value ◽  
Postpartum Bonding ◽  
Test Retest Reliability

Abstract The aim of the present study was to validate the Spanish Postpartum Bonding Questionnaire (PBQ) against external criteria of bonding disorder, as well as to establish its test-retest reliability. One hundred fifty-six postpartum women consecutively recruited from a perinatal mental health outpatient unit completed the PBQ at 4–6 weeks postpartum. Four weeks later, all mothers completed again the PBQ and were interviewed using the Birmingham Interview for Maternal Mental Health to establish the presence of a bonding disorder. Receiver operating characteristic curve analysis revealed an area under the curve (AUC) value for the PBQ total score of 0.93, 95% CI [0.88, 0.98], with the optimal cut-off of 13 for detecting bonding disorders (sensitivity: 92%, specificity: 87%). Optimal cut-off scores for each scale were also obtained. The test-retest reliability coefficients were moderate to good. Our data confirm the validity of PBQ for detecting bonding disorders in Spanish population.

Psychometric properties of patient reported outcome (PRO) instruments in patients with small cell lung cancer (SCLC) in RESILIENT part 1.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e24027-e24027
Author(s):  
Jaba Kokhreidze ◽  
Veleka Allen ◽  
Cristina Ivanescu ◽  
Xiaopan Valerie Yao ◽  
Bin Zhang ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Construct Validity ◽  
Psychometric Properties ◽  
Internal Consistency ◽  
Life Questionnaire ◽  
Retest Reliability ◽  
Patient Reported ◽  
Eortc Qlq ◽  
Test Retest Reliability ◽  
Pro Instruments

e24027 Background: The ongoing two-part phase 2/3 RESILIENT study (NCT03088813) is investigating the efficacy and safety of liposomal irinotecan monotherapy in patients with SCLC who have progressed on or after first line platinum-based chemotherapy. This exploratory analysis from RESILIENT part 1 was conducted to confirm the psychometric properties of established PRO instruments that had not previously been validated in patients with SCLC. Methods: Patients completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) Core 30 (C30) and the EORTC QLQ Lung Cancer 13 (LC13) before treatment assignment (baseline), every 6 weeks thereafter, at treatment discontinuation and at the 30-day follow-up visit. Psychometric methods included descriptive statistics (items and scales), correlations (item-to-item and item-to-total), internal consistency (Cronbach’s α), test-retest reliability (intraclass correlation coefficient [ICC], two-way random effects model), construct validity and sensitivity to change. The analysis included patients who received at least one dose of study drug and completed at least one PRO assessment. Results: Thirty patients were enrolled in RESILIENT part 1 and included in the analysis. At baseline, 68% of patients reported ‘not severe’ or ‘mild’ symptoms. Floor effects (i.e. more than 25% of responses of ‘not at all’) were observed for several of the functioning/impact and symptom scales of the EORTC QLQ C30 and LC13. Moderate to strong correlations were found among most questionnaire items within their respective scales. Acceptable evidence for internal consistency and good test-retest reliability were observed. Selected results for the EORTC QLQ LC13, including dyspnea scales, are shown in the Table. The magnitude of correlations among PRO instruments supported evidence for convergent validity in this sample. Conclusions: In RESILIENT part 1, patients experienced low and tolerable symptoms at enrollment, limiting the potential for further improvement. Overall, these PRO instruments had acceptable psychometric properties (e.g. construct validity, reliability and ability to detect change) in this sample. However, these analyses should be repeated in a larger sample using data from RESILIENT part 2. Clinical trial information: NCT03088813. [Table: see text]

scholarly journals Effect sizes and test-retest reliability of the fMRI-based Neurologic Pain Signature

2021 ◽  
Author(s):  
Xiaochun Han ◽  
Yoni K. Ashar ◽  
Philip Kragel ◽  
Bogdan Petre ◽  
Victoria Schelkun ◽  
...  
Keyword(s):  
Individual Differences ◽  
Effect Size ◽  
Mental States ◽  
Effect Sizes ◽  
Medium Effect ◽  
Retest Reliability ◽  
Medium Effect Size ◽  
Pain Reports ◽  
Nociceptive Input ◽  
Test Retest Reliability

Identifying biomarkers that predict mental states with large effect sizes and high test-retest reliability is a growing priority for fMRI research. We examined a well-established multivariate brain measure that tracks pain induced by nociceptive input, the Neurologic Pain Signature (NPS). In N = 295 participants across eight studies, NPS responses showed a very large effect size in predicting within-person single-trial pain reports (d = 1.45) and medium effect size in predicting individual differences in pain reports (d = 0.49, average r = 0.20). The NPS showed excellent short-term (within-day) test-retest reliability (ICC = 0.84, with average 69.5 trials/person). Reliability scaled with the number of trials within-person, with ≥60 trials required for excellent test-retest reliability. Reliability was comparable in two additional studies across 5-day (N = 29, ICC = 0.74, 30 trials/person) and 1-month (N = 40, ICC = 0.46, 5 trials/person) test-retest intervals. The combination of strong within-person correlations and only modest between-person correlations between the NPS and pain reports indicates that the two measures have different sources of between-person variance. The NPS is not a surrogate for individual differences in pain reports, but can serve as a reliable measure of pain-related physiology and mechanistic target for interventions.

scholarly journals Patient-Reported Outcomes Measurement Information System (PROMIS) in Femoroacetabular Impingement (FAI)

2019 ◽  
Vol 7 (7_suppl5) ◽  
pp. 2325967119S0026
Author(s):  
Anas Minkara ◽  
Michaela O’Connor ◽  
Robert W. Westermann ◽  
James T. Rosneck ◽  
Thomas Sean Lynch
Keyword(s):  
Hip Arthroscopy ◽  
Patient Reported Outcomes ◽  
Pain Interference ◽  
Measurement Information ◽  
Retest Reliability ◽  
Pearson Coefficient ◽  
Patient Reported ◽  
Ceiling Effects ◽  
Measurement Information System ◽  
Test Retest Reliability

Objectives: Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH-funded computerized adaptive test (CAT) developed to effectively assess patient outcomes in multiple domains, including physical function (PF), pain severity, and quality of life while minimizing patient burden. The purpose of this study is to validate PROMIS in patients undergoing hip arthroscopy for Femoroacetabular Impingement (FAI), including test-retest reliability and correlation with validated hip outcome measures. Methods: Patients undergoing elective hip arthroscopy for FAI were consecutively enrolled at a major academic center. Patients with chronic comorbidities, bilateral FAI with a staged approach, and lack of postoperative follow-up were excluded. Eligible patients completed the modified Hip Harris Score (mHHS), Hip Outcome Score Activities of Daily Living (HOS-ADL), International Hip Outcome Tool (iHOT-12), and PROMIS including PF, pain interference, and activity satisfaction. Questionnaires were completed preoperatively, two, and six weeks postoperatively. Ceiling effects were determined to be present if greater than 15% of patients scored the highest possible score on one of the patient reported outcome measurement tools in this study. The correlation of preoperative values with postoperative function were assessed utilizing the Pearson coefficient. Normality was evaluated using the Shapiro-Wilk test. Dependent sample t-tests were utilized to compare means in test-retest reliability. Results: There were 38 patients with a mean age of 29.3 ± 8.9 years (54% female) identified for the study. PROMIS demonstrated excellent correlation with HOS-ADL (Pearson coefficient of 0.81, Figure 1), as well as mHHS (0.80) and iHOT-12 (0.73). Patients with higher PROMIS-pain interference and pain intensity scores demonstrated a negative linear correlation with mHHS (r=-0.86, p<0.05), HOS-ADL (r=-0.71, p<0.05), and iHOT-12 (-0.71, p<0.01). PROMIS scores exhibited significant responsiveness to hip arthroscopy. Patients with higher activity satisfaction demonstrated excellent-good correlation with mHHS scores (r=0.66, p<0.05) and HOS-ADL (0.66, p<0.05). PROMIS also demonstrated excellent test-retest reliability with no variability in scores, including PF (55.5 ± 8.6 vs. 54.2 ± 10.5, p=0.74). No floor or ceiling effects were exhibited by PROMIS including the physical function, pain interference, pain intensity, social participation, and role satisfaction domain scores. Conclusion: PROMIS is a valid and efficient PRO in hip arthroscopy for FAI demonstrating excellent test-retest reliability and correlation with established hip outcome measures. No floor or ceiling effects were demonstrated by PROMIS. Subdomains also exhibit excellent prognostic ability in the clinical setting.

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