scholarly journals Clinimetric Criteria for Patient-Reported Outcome Measures

2021 ◽  
pp. 1-11
Author(s):  
Danilo Carrozzino ◽  
Chiara Patierno ◽  
Jenny Guidi ◽  
Carmen Berrocal Montiel ◽  
Jianxin Cao ◽  
...  

Patient-reported outcome measures (PROMs) are self-rated scales and indices developed to improve the detection of the patients’ subjective experience. Given that a considerable number of PROMs are available, it is important to evaluate their validity and usefulness in a specific research or clinical setting. Published guidelines, based on psychometric criteria, do not fit in with the complexity of clinical challenges, because of their quest for homogeneity of components and inadequate attention to sensitivity. Psychometric theory has stifled the field and led to the routine use of scales widely accepted yet with a history of poor performance. Clinimetrics, the science of clinical measurements, may provide a more suitable conceptual and methodological framework. The aims of this paper are to outline the major limitations of the psychometric model and to provide criteria for clinimetric patient-reported outcome measures (CLIPROMs). The characteristics related to reliability, sensitivity, validity, and clinical utility of instruments are critically reviewed, with particular reference to the differences between clinimetric and psychometric approaches. Of note is the fact that PROMs, rating scales, and indices developed according to psychometric criteria may display relevant clinimetric properties. The present paper underpins the importance of the clini­metric methodology in choosing the appropriate PROMs. CLIPROM criteria may also guide the development of new indices and the validation of existing PROMs to be employed in clinical settings.

Strabismus ◽  
2017 ◽  
Vol 25 (1) ◽  
pp. 33-38 ◽  
Author(s):  
Sarah R. Hatt ◽  
David A. Leske ◽  
Suzanne M. Wernimont ◽  
Eileen E. Birch ◽  
Jonathan M. Holmes

2021 ◽  
Vol 30 (160) ◽  
pp. 210026
Author(s):  
Meena Kalluri ◽  
Fabrizio Luppi ◽  
Ada Vancheri ◽  
Carlo Vancheri ◽  
Elisabetta Balestro ◽  
...  

Patient-reported outcome measures (PROMs), tools to assess patient self-report of health status, are now increasingly used in research, care and policymaking. While there are two well-developed disease-specific PROMs for interstitial lung diseases (ILD) and idiopathic pulmonary fibrosis (IPF), many unmet and urgent needs remain. In December 2019, 64 international ILD experts convened in Erice, Italy to deliberate on many topics, including PROMs in ILD. This review summarises the history of PROMs in ILD, shortcomings of the existing tools, challenges of development, validation and implementation of their use in clinical trials, and the discussion held during the meeting. Development of disease-specific PROMs for ILD including IPF with robust methodology and validation in concordance with guidance from regulatory authorities have increased user confidence in PROMs. Minimal clinically important difference for bidirectional changes may need to be developed. Cross-cultural validation and linguistic adaptations are necessary in addition to robust psychometric properties for effective PROM use in multinational clinical trials. PROM burden of use should be reduced through appropriate use of digital technologies and computerised adaptive testing. Active patient engagement in all stages from development, testing, choosing and implementation of PROMs can help improve probability of success and further growth.


2021 ◽  
Vol 2 (2) ◽  
Author(s):  
Keith Meadows

Patient-reported outcome measures (PROMs) are valued in healthcare evaluation for bringing patient perspectives forward, and enabling patient-centered care. The range of evidence permitted by PROMs to measure patients’ quality of life narrowly denies subjective experience. This neglect is rooted in the epistemic assumptions that ground PROMs, and the tension between the standardization (the task of measurement) and the individual and unique circumstances of patients. To counter the resulting methodological shortcomings, this article proposes a hermeutical approach and interpretive phenomenology instead of generic qualitative research methods.


2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0048
Author(s):  
Kempland C. Walley ◽  
Emily Vannatta ◽  
Chris M. Stauch ◽  
Madelaine W. Fritsche ◽  
Mark Dunleavy ◽  
...  

Category: Other Introduction/Purpose: Used intimately to qualify the use of new surgical devices, advance new surgical techniques and evaluate faculty performance with regard to patient satisfaction and outcomes, patient reported outcome measures (PROMs) are commonplace across all sub-specialties in orthopaedics. Despite their theorized utility, these interactive tools are burdensome in clinic and their true utility is anecdotally in question. No prior study to the best of our knowledge has investigated the degree at which patients find them useful or even appropriate measures to objectify their injuries or state of recovery. The purpose of this study is to ascertain patient perceptions of the utility of commonly used patient reported outcome measures (PROMs) in foot and ankle surgery. Methods: After IRB approval, consecutive patients visiting a foot and ankle surgery outpatient clinic (either new or return) will be asked to complete a survey assessing their attitudes toward commonly used PROMs relevant to foot and ankle surgery. Upon verbal consent, patients will be asked a short series of demographic questions including: age, whether they are a new patient, sex, education level, disability status, current region of residence, and history of opiate use. After completion, patients will be shown the Visual Analog Scale (VAS) tool to quantify pain and asked two questions: 1) concerning effectiveness and 2) concerning their personal perceptions. Next, patients will be shown a single PROM used pertaining to their injury (eg, Foot & Ankle Disability Index (FADI)). All patient will comment on their perceptions of the VAS and one additional PROM specific to the sub-specialty in which there are seeking treatment. Results: We report a total of 39 patients in this preliminary data set (49% males, 51% females) with a mean age of 51 (range, 19 - 83). A majority of patients reported that both VAS and FADI are effective PROMs in foot and ankle surgery. Additionally, patients reported that there is no benefit to artificially inflating their PROMs to receive better/more-prompt patient care. These findings were independent of history of opiate use, disability, gender, or age cohort (Figure 1). Conclusion: The results of this study show that the majority of patients visiting a foot and ankle surgeon in the outpatient setting perceive both VAS and FADI are effective tools to describe their respective foot/ankle condition. Patients report, in this preliminary sample, do not ‘game’ these PROMs to receive better care though these study findings are subject to the Hawthorne Effect.


2018 ◽  
Vol 6 (5) ◽  
pp. 232596711877331 ◽  
Author(s):  
Drew A. Lansdown ◽  
Gift Ukwuani ◽  
Benjamin Kuhns ◽  
Joshua D. Harris ◽  
Shane J. Nho

Background: Femoroacetabular impingement (FAI) is responsible for hip pain and dysfunction, and surgical outcomes depend on multiple factors. The presence of mental disorders negatively influences outcomes of multiple orthopaedic conditions, although the impact on FAI surgery is unclear. Hypothesis: The authors hypothesized that a preoperative self-reported history of mental disorders would negatively influence patient-reported outcome measures after FAI surgery. Study Design: Cohort study; Level of evidence, 3. Methods: A matched-cohort study was performed by reviewing a prospectively collected database of cases of arthroscopic management of FAI with a single surgeon over a 2-year period. Demographics and radiographic parameters were recorded for all patients. Patients completed the Hip Outcome Score–Activity of Daily Living Subscale (HOS-ADL), Hip Outcome Score–Sport-Specific Subscale (HOS-SSS), and modified Harris Hip Score (mHHS) prior to surgery and 2 years after surgery. Unpaired and paired t tests were used to compare results between and within cohorts at baseline and follow-up. Statistical significance was defined as P < .05. Results: The cohort included 301 patients, with 75 and 226 patients reporting and not reporting a history of mental disorders, respectively. Before treatment, all patient-reported outcome measures were significantly lower among patients reporting a history of mental disorders ( P < .01 for HOS-ADL, HOS-SSS, and mHHS). Patients in both groups demonstrated significant improvements ( P < .0001) in HOS-ADL, HOS-SSS, and mHHS when preoperative outcome measures were compared with follow-up. Patients with reported mental disorders had significantly lower scores after surgery as compared with patients without mental disorders ( P < .0001 for HOS-ADL, HOS-SSS, and mHHS). Conclusion: The presence of a reported mental disorder is associated with lower patient-reported outcomes before and after surgical management of FAI. Statistically significant and clinically relevant improvements were observed for patients who reported mental disorders. The magnitude of these improvements was not as large as that for an age- and sex-matched control group without a self-reported mental disorder.


Spine ◽  
2018 ◽  
Vol 43 (6) ◽  
pp. 434-439 ◽  
Author(s):  
Robert K. Merrill ◽  
Lukas P. Zebala ◽  
Colleen Peters ◽  
Sheeraz A. Qureshi ◽  
Steven J. McAnany

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