Comparability of Patient-reported Outcome Measures and Clinical Assessment Tools for Shoulder Function in Patients with Proximal Humeral Fracture

Author(s):  
Elke Maurer ◽  
Christian Bahrs ◽  
Luise Kühle ◽  
Patrick Ziegler ◽  
Christoph Gonser ◽  
...  

Abstract Background Patient-reported outcome measures (PROMs) are gaining increasing importance in the context of quality management. Different PROMs and scoring tools are available to assess shoulder function after proximal humeral fracture (PHFx). In Europe, these include the Constant-Murley Score (CS), Neer Score (NS), Oxford Shoulder Score (OSS), University of California at Los Angeles Score (UCLA) and Disabilities of the Arm, Shoulder and Hands Score (DASH). In addition, the health-related quality of life can be assessed by the PROMs Short Form 36 (SF-36) and EuroQol (EQ-5D). Although all these test instruments assess shoulder function, the components to be answered objectively and subjectively vary and thus the possibility of independent assessment. The aim of the present study is to compare the correlation between the results of the different PROMs and the clinical screening tools in patients with PHFx. Methods 76 patients who were treated with angular stable plate osteosynthesis for a proximal humeral fracture between 01/2001 and 12/2005 were included in this trial. The outcome was measured with PROMs or clinical scoring tools such as CS, NS, OSS, UCLA, DASH, SF-36 and EQ-5D and a correlation coefficient between those evaluation tools was calculated. In addition, a distinction was made between the two force measurement methods (wrist [HG] vs. deltoid muscle [DM]) for CS. Results The correlation of the results of CS and NS (HG: r = 0.85; p < 0.001/DM: r = 0.93; p < 0.001), CS and UCLA (HG: r = 0.83; p < 0.001/DM: r = 0.86; p < 0.001), NS and UCLA (r = 0.91; p < 0.001) as well as DASH and OSS (r = 0.88; p < 0.001) was strongly expressed. A good comparability of the results was demonstrated between CS and OSS (HG: r = 0.63; p < 0.001/DM: r = 0.66; p < 0.001) and between CS and DASH (HG: r = 0.62; p < 0.001/DM: r = 0.61; p < 0.001). The correlation of CS (HG/DM) and UCLA with the EQ-5D index was also good. Assessment of the physical components of SF-36 with CS, NS, OSS, UCLA and DASH showed a moderate to good association, while the mental components of SF-36 showed a low correlation (p > 0.05). Conclusion The assessment of shoulder function after proximal humerus fracture showed a very strong correlation within the clinical questionnaires (CS/NS/UCLA) and the PROMs (OSS/DASH). A strong correlation also exists between the clinical questionnaires and the PROMs. There was only a moderate correlation with the EQ-5D. The moderate to strong correlation between the physical components of SF-36, with almost no correlation between the mental components of SF-36, indicates that the quality of life restriction is based on a physical, but not on a mental impairment.

Author(s):  
John Brazier ◽  
Julie Ratcliffe ◽  
Joshua A. Salomon ◽  
Aki Tsuchiya

This chapter provides the rationale for measuring and valuing health benefits for economic evaluation. It covers the limitation of using conventional patient-reported outcome measures of health (e.g. SF-36) in economic evaluation. It then introduces the quality-adjusted life year (QALY), which attempts to value the benefits of health care in terms of a measure that combines the impact on survival and quality of life using the numeraire of a year in full health. This chapter introduces the core building blocks of measuring and valuing health: describing health; techniques for valuing health; deciding who should value health; and taking account of social consideration in the aggregation of QALYs.


Author(s):  
Michaela Gabes ◽  
Helge Knüttel ◽  
Gesina Kann ◽  
Christina Tischer ◽  
Christian J. Apfelbacher

Abstract Purpose To critically appraise, compare and summarize the quality of all existing PROMs that have been validated in hyperhidrosis to at least some extend by applying the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Thereby, we aim to give a recommendation for the use of PROMs in future clinical trials in hyperhidrosis. Methods We considered studies evaluating, describing or comparing measurement properties of PROMs as eligible. A systematic literature search in three big databases (MEDLINE, EMBASE and Web of Science) was performed. We assessed the methodological quality of each included study using the COSMIN Risk of Bias checklist. Furthermore, we applied predefined quality criteria for good measurement properties and finally, graded the quality of the evidence. Results Twenty-four articles reporting on 13 patient-reported outcome measures were included. Three instruments can be further recommended for use. They showed evidence for sufficient content validity and moderate- to high-quality evidence for sufficient internal consistency. The methodological assessment showed existing evidence gaps for eight other PROMs, which therefore require further validation studies to make an adequate decision on their recommendation. The Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) and the short-form health survey with 36 items (SF-36) were the only questionnaires not recommended for use in patients with hyperhidrosis due to moderate- to high-quality evidence for insufficient measurement properties. Conclusion Three PROMs, the Hyperhidrosis Quality of Life Index (HidroQoL), the Hyperhidrosis Questionnaire (HQ) and the Sweating Cognitions Inventory (SCI), can be recommended for use in future clinical trials in hyperhidrosis. Results obtained with these three instruments can be seen as trustworthy. Nevertheless, further validation of all three PROMs is desirable. Systematic review registration PROSPERO CRD42020170247


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Salzwedel ◽  
I Koran ◽  
E Langheim ◽  
A Schlitt ◽  
J Nothroff ◽  
...  

Abstract Introduction Comprehensive cardiac rehabilitation (CR) programs based on the bio-psycho-social approach of the international classification of functioning and disease are carried out to achieve improved prognosis, superior health-related quality of life (HRQL) and social integration. We aimed to identify predictors of returning to work (RTW) and HRQL among cardiovascular risk factors and physical performance as well as patient-reported outcome measures (PROMs) modifiable during CR. Methods We designed a prospective observational multi-center study and enrolled 1,586 patients (2017/18) in 12 German rehabilitation centers regardless of their primary allocation diagnoses (e.g. acute myocardial infarction (AMI), coronary artery bypass grafting (CABG), coronary artery disease (CAD), valvular disease). Besides general data (e.g. age, gender, diagnoses), parameters of risk factor management (e.g. smoking, lipid profile, hypertension, lifestyle change motivation), physical performance (e.g. maximum exercise capacity, endurance training load, 6-min walking distance), and PROMs (e.g. depression, heart-focused anxiety, HRQL, subjective well-being, somatic and mental health, pain, general self-efficacy, pension desire as well as self-assessment of occupational prognosis using several questionnaires) were documented at CR admission and discharge. 6 months after discharge, status of RTW and HRQL (SF-12) were captured by a follow-up (FU) survey and analyzed in multivariable regression models with multiple imputation of missing values. Results Out of the study participants, 1,262 patients (54±7 years, 77% men) responded to the follow-up survey and could be analyzed regarding the outcome parameters. Most of them were assigned to CR primarily due to AMI (40%) or CAD without myocardial infarction (18%), followed by heart valve diseases in 12% of patients and CABG (8%). 864 patients (69%) returned to work within the follow-up period. Pension desire, negative self-assessed occupational prognosis, heart-focussed anxiety, major life events, smoking and heart failure were negatively associated with RTW, while higher endurance training load, HRQL and work stress were positively associated (Figure 1). HRQL after 6 months was determined more by PROMs (e.g. pension desire, heart-focused anxiety, physical/mental HRQL in SF-12, physical/mental health in indicators of rehab-status questionnaire (IRES-24), stress, well-being in the World Health Organization well-being index and self-efficacy expectations) than by clinical parameters or physical performance. Conclusions Patient-reported outcome measures predominantly influenced RTW and HRQL in heart-disease patients, whereas patients' pension desire and heart-focussed anxiety had a dominant impact on all investigated endpoints. Therefore, the multi-component CR approach focussing on psychosocial support is crucial for subjective health prognosis and occupational resumption. Figure 1. Predictors of returning to work Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): German pension insurance


2020 ◽  
Vol 28 (1) ◽  
pp. 386-404 ◽  
Author(s):  
C. F. Davies ◽  
R. Macefield ◽  
K. Avery ◽  
J. M. Blazeby ◽  
S. Potter

Abstract Background Breast reconstruction (BR) is performed to improve outcomes for patients undergoing mastectomy. A recently developed core outcome set for BR includes six patient-reported outcomes that should be measured and reported in all future studies. It is vital that any instrument used to measure these outcomes as part of a core measurement set be robustly developed and validated so data are reliable and accurate. The aim of this systematic review is to evaluate the development and measurement properties of existing BR patient-reported outcome measures (PROMs) to inform instrument selection for future studies. Methods A PRISMA-compliant systematic review of development and validation studies of BR PROMs was conducted to assess their measurement properties. PROMs with adequate content validity were assessed using three steps: (1) the methodological quality of each identified study was assessed using the COSMIN Risk of Bias checklist; (2) criteria were applied for assessing good measurement properties; and (3) evidence was summarized and the quality of evidence assessed using a modified GRADE approach. Results Fourteen articles reported the development and measurement properties of six PROMs. Of these, only three (BREAST-Q, BRECON-31, and EORTC QLQ-BRECON-23) were considered to have adequate content validity and proceeded to full evaluation. This showed that all three PROMs had been robustly developed and validated and demonstrated adequate quality. Conclusions BREAST-Q, BRECON-31, and EORTC QLQ-BRECON-23 have been well-developed and demonstrate adequate measurement properties. Work with key stakeholders is now needed to generate consensus regarding which PROM should be recommended for inclusion in a core measurement set.


2021 ◽  
Vol 264 ◽  
pp. 394-401
Author(s):  
Mary Kate Luddy ◽  
Rachel Vetter ◽  
Jessica Shank ◽  
Whitney Goldner ◽  
Anery Patel ◽  
...  

2018 ◽  
Vol 25 (13) ◽  
pp. 1791-1799 ◽  
Author(s):  
Brian C Healy ◽  
Jonathan Zurawski ◽  
Cindy T Gonzalez ◽  
Tanuja Chitnis ◽  
Howard L Weiner ◽  
...  

Background: To date, the computerized adaptive testing (CAT) version of the Neuro-quality of life (QOL) has not been assessed in a large sample of people with multiple sclerosis (MS). Objective: The aim of this study was to assess the associations between the CAT version of Neuro-QOL and other clinical and patient-reported outcome measures. Methods: Subjects ( n = 364) enrolled in SysteMS completed the CAT version of the Neuro-QOL and the 36-Item Short Form Survey (SF-36) within 4 weeks of a clinical exam that included the Multiple Sclerosis Functional Composite-4 (MSFC-4). The correlations between the Neuro-QOL domains and the MSFC-4 subscores and the SF-36 scores were calculated. The changes over time in the Neuro-QOL and other measures were also examined. Results: The lower extremity functioning score of the Neuro-QOL showed the highest correlations with MSFC-4 components including Timed 25-Foot Walk, 9-Hole Peg Test, and cognitive score. The expected domains of the Neuro-QOL showed high correlations with the SF-36 subscores, and some Neuro-QOL domains were associated with many SF-36 subscores. There was limited longitudinal change on the Neuro-QOL domains over 12 months, and the change was not associated with change on other measures. Conclusion: The CAT version of the Neuro-QOL shows many of the expected associations with clinical and patient-reported outcome measures.


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