The effectiveness of manipulation of fingers with Dupuytren's contracture 7 days after collagenase clostridial histolyticum injection

Timing of manipulation of digits after collagenase injection for Dupuytren’s disease varies and often takes place within the first few days post-injection. We prospectively investigated the effectiveness of performing manipulation under local anaesthesia 7 days after injection in 100 patients. Demographic data, passive extension deficit, and patient-reported outcome measures were recorded before collagenase injection. Four to 7 weeks after manipulation, passive extension deficit and patient-reported outcome measures improved significantly without the development of any tendon ruptures. Clinical success was achieved in 41% and clinical improvement in 76% of the patients. Adverse events were reported by 85%. The outcomes were comparable with studies with early manipulation, and demonstrate a safe and effective variation to current protocols. We conclude that delaying manipulation to 7 days after collagenase injection is safe and efficient, which allows for flexibility in clinical appointments without negatively affecting outcome. Level of evidence: III

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Enabling patient-reported outcome measures in clinical trials, exemplified by cardiovascular trials

Health and Quality of Life Outcomes ◽

10.1186/s12955-021-01800-1 ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Theresa M. Coles ◽

Adrian F. Hernandez ◽

Bryce B. Reeve ◽

Karon Cook ◽

Michael C. Edwards ◽

...

Keyword(s):

Clinical Trials ◽

Outcome Measures ◽

Contextual Factors ◽

The United States ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Think Tank ◽

Level Of Evidence ◽

Patient Reported ◽

Evidentiary Standards

Abstract Objectives There has been limited success in achieving integration of patient-reported outcomes (PROs) in clinical trials. We describe how stakeholders envision a solution to this challenge. Methods Stakeholders from academia, industry, non-profits, insurers, clinicians, and the Food and Drug Administration convened at a Think Tank meeting funded by the Duke Clinical Research Institute to discuss the challenges of incorporating PROs into clinical trials and how to address those challenges. Using examples from cardiovascular trials, this article describes a potential path forward with a focus on applications in the United States. Results Think Tank members identified one key challenge: a common understanding of the level of evidence that is necessary to support patient-reported outcome measures (PROMs) in trials. Think Tank participants discussed the possibility of creating general evidentiary standards depending upon contextual factors, but such guidelines could not be feasibly developed because many contextual factors are at play. The attendees posited that a more informative approach to PROM evidentiary standards would be to develop validity arguments akin to courtroom briefs, which would emphasize a compelling rationale (interpretation/use argument) to support a PROM within a specific context. Participants envisioned a future in which validity arguments would be publicly available via a repository, which would be indexed by contextual factors, clinical populations, and types of claims. Conclusions A publicly available repository would help stakeholders better understand what a community believes constitutes compelling support for a specific PROM in a trial. Our proposed strategy is expected to facilitate the incorporation of PROMs into cardiovascular clinical trials and trials in general.

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The Influence of Health Perception on Shoulder Outcome Measure Scores

Clinics in Shoulder and Elbow ◽

10.5397/cise.2019.22.4.173 ◽

2019 ◽

Vol 22 (4) ◽

pp. 173-182

Author(s):

Richard E. Hardy ◽

Engin Sungur ◽

Christopher Butler ◽

Jefferson C. Brand

Keyword(s):

Outcome Measures ◽

Prediction Models ◽

Constant Score ◽

Case Series ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Level Of Evidence ◽

Individualized Care ◽

Sf 36 ◽

Patient Reported

Background: Patient reported outcome measures assess clinical progress from the patient’s perspective. This study explored the relationship between shoulder outcome measures (The Disability of the Arm, Shoulder and Hand [DASH], American Shoulder and Elbow Surgeons Standard Shoulder Assessment score [ASES], and Constant score) by comparing the best possible scores obtained in an asymptomatic population compared to overall perception of health, as measured by the SF-36 outcome measure.Methods: Volunteers (age range, 20?69 years) with asymptomatic shoulders and no history of shoulder pain, injury, surgery, imaging, or pathology (bilaterally) were included. The DASH and ASES measures were completed by 111 volunteers (72 female, 39 male), of which 92 completed the Constant score (56 female, 36 male). The SF-36 was completed by all volunteers (level of evidence: IV case series).Results: The mean (x) score for ASES measure on the right shoulder was higher for the left-hand dominant side (x=100.00 vs. 95.02, <i>p</i>-value<0.001); no other significant differences. Better SF-36 scores were associated with better DASH scores. Our prediction models suggest that perception of overall health affects the DASH scores. Sex affected all three shoulder measures scores.Conclusions: Comparing scores of shoulder outcome measures to the highest possible score is not the most informative way to interpret patient progress. Variables such as health status, sex, and hand dominance need to be considered. Furthermore, it is possible to use these variables to predict scores of outcome measures, which facilitates the healthcare provider to deliver individualized care to their patients.

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Measurement Properties of Patient-Reported Outcome Measures for Diabetes: Systematic Review

Journal of Medical Internet Research ◽

10.2196/25002 ◽

2021 ◽

Vol 23 (8) ◽

pp. e25002

Author(s):

Priscilla Jia Ling Wee ◽

Yu Heng Kwan ◽

Dionne Hui Fang Loh ◽

Jie Kie Phang ◽

Troy H Puar ◽

...

Keyword(s):

Systematic Review ◽

Type 2 Diabetes ◽

Outcome Measures ◽

Systematic Reviews ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Measurement Properties ◽

Level Of Evidence ◽

Patient Reported

Background The management of diabetes is complex. There is growing recognition of the use of patient-reported outcome measures (PROMs) as a standardized method of obtaining an outlook on patients’ functional status and well-being. However, no systematic reviews have summarized the studies that investigate the measurement properties of diabetes PROMs. Objective Our aims were to conduct a systematic review of studies investigating the measurement properties of diabetes PROMs by evaluating the methodological quality and overall level of evidence of these PROMs and to categorize them based on the outcome measures assessed. Methods This study was guided by the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) guidelines. Relevant articles were retrieved from the Embase, PubMed, and PsychINFO databases. The PROMs were evaluated with the COSMIN (COnsensus-based Standards for the selection of health Measurement Instruments) guidelines. Results A total of 363 articles evaluating the measurement properties of PROMs for diabetes in the adult population were identified, of which 238 unique PROMs from 248 studies reported in 209 articles were validated in the type 2 diabetes population. PROMs with at least a moderate level of evidence for ≥5 of 9 measurement properties include the Chinese version of the Personal Diabetes Questionnaire (C-PDQ), Diabetes Self-Management Instrument Short Form (DSMI-20), and Insulin Treatment Appraisal Scale in Hong Kong primary care patients (C-ITAS-HK), of which the C-PDQ has a “sufficient (+)” rating for >4 measurement properties. A total of 43 PROMs meet the COSMIN guidelines for recommendation for use. Conclusions This study identified and synthesized evidence for the measurement properties of 238 unique PROMs for patients with type 2 diabetes and categorized the PROMs according to their outcome measures. These findings may assist clinicians and researchers in selecting appropriate high-quality PROMs for clinical practice and research. Trial Registration PROSPERO International Prospective Register of Systematic Reviews CRD42020180978; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020180978.

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Measurement Properties of Patient-Reported Outcome Measures for Diabetes: Systematic Review (Preprint)

10.2196/preprints.25002 ◽

2020 ◽

Author(s):

Priscilla Jia Ling Wee ◽

Yu Heng Kwan ◽

Dionne Hui Fang Loh ◽

Jie Kie Phang ◽

Troy H Puar ◽

...

Keyword(s):

Systematic Review ◽

Type 2 Diabetes ◽

Outcome Measures ◽

Systematic Reviews ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Measurement Properties ◽

Level Of Evidence ◽

Patient Reported

BACKGROUND The management of diabetes is complex. There is growing recognition of the use of patient-reported outcome measures (PROMs) as a standardized method of obtaining an outlook on patients’ functional status and well-being. However, no systematic reviews have summarized the studies that investigate the measurement properties of diabetes PROMs. OBJECTIVE Our aims were to conduct a systematic review of studies investigating the measurement properties of diabetes PROMs by evaluating the methodological quality and overall level of evidence of these PROMs and to categorize them based on the outcome measures assessed. METHODS This study was guided by the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) guidelines. Relevant articles were retrieved from the Embase, PubMed, and PsychINFO databases. The PROMs were evaluated with the COSMIN (COnsensus-based Standards for the selection of health Measurement Instruments) guidelines. RESULTS A total of 363 articles evaluating the measurement properties of PROMs for diabetes in the adult population were identified, of which 238 unique PROMs from 248 studies reported in 209 articles were validated in the type 2 diabetes population. PROMs with at least a moderate level of evidence for ≥5 of 9 measurement properties include the Chinese version of the Personal Diabetes Questionnaire (C-PDQ), Diabetes Self-Management Instrument Short Form (DSMI-20), and Insulin Treatment Appraisal Scale in Hong Kong primary care patients (C-ITAS-HK), of which the C-PDQ has a “sufficient (+)” rating for >4 measurement properties. A total of 43 PROMs meet the COSMIN guidelines for recommendation for use. CONCLUSIONS This study identified and synthesized evidence for the measurement properties of 238 unique PROMs for patients with type 2 diabetes and categorized the PROMs according to their outcome measures. These findings may assist clinicians and researchers in selecting appropriate high-quality PROMs for clinical practice and research. CLINICALTRIAL PROSPERO International Prospective Register of Systematic Reviews CRD42020180978; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020180978.

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Different collagenase delivery for Dupuytren disease in public hospitals

Australasian Journal of Plastic Surgery ◽

10.34239/ajops.v3n2.163 ◽

2020 ◽

Vol 3 (2) ◽

pp. 22-31

Author(s):

Jessca A Paynter ◽

Vicky Tobin ◽

James CS Leong ◽

Warren Matthew Rozen ◽

David J Hunter-Smith

Keyword(s):

Clinical Success ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Public Hospitals ◽

Dupuytren’S Disease ◽

Patient Specific ◽

Extension Deficit ◽

Dupuytren's Disease ◽

Number Of Patients ◽

Patient Reported

Background: The delivery protocol of collagenase Clostridium histolyticum (collagenase) injection for Dupuytren’s disease is variable, due to limited evidence for any one approach and widespread ‘off-label’ delivery occurring in Australia. As such, this preliminary study aimed to assess whether different collagenase delivery protocols for treating Dupuytren’s disease have an impact on effectiveness and safety. It was hypothesised that different collagenase delivery would affect outcomes. Methods: This preliminary, prospective study included a consecutive cohort of adult patients with Dupuytren’s disease being treated with collagenase within two Australian public hospitals to determine whether different collagenase delivery protocols impact on effectiveness and safety. The therapeutic effect was measured objectively using the total passive extension deficit (TPED), clinical success and clinical improvement. Three patient-reported outcome measures (PROMs) were used: Unité Rhumatologique des Affections de la Main (URAM), the Southampton Dupuytren’s Scoring Scheme and the Canadian Occupational Patient-Specific Functional Scale (PSFS). Results: The delivery of collagenase was variable at both clinics. The number of patients treated with collagenase at Institute I and Institute II was 49 and 18, respectively. Clinical success was achieved in 42 per cent of the Institute I and 35 per cent of the Institute II cohort. A statistically significant reduction in all three PROMs was observed for both cohorts. No significant differences between effectiveness or safety was found when comparing the two cohorts. Conclusion: The delivery of collagenase was variable at Institutes I and II, but these differences did not appear to impact the effectiveness or safety of collagenase delivery.

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