Interpretation Of Patient-reported Outcome Measures Research Articles

Patient-Reported Outcome Measures in Neuromuscular Diseases: A Scoping Review.

Patient-reported outcome measures (PROMs) are valuable in comprehensively understanding patients' health experiences and informing healthcare decisions in research and clinical care without clinicians' input. Until now, no central resource containing information on all PROMS in neuromuscular diseases (NMD) is available, hindering the comparison and choice of PROMs used to monitor NMDs and appropriately reflect the patient's voice. This scoping review aimed to present a comprehensive assessment of the existing literature on using PROMs in children and adults with NMD. A scoping methodology was followed using Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) and COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines to assess the literature on PROMs in NMDs. Eligibility criteria encompassed articles describing psychometric development or evaluation of generic or disease-specific PROM-based instruments for adults and children with specific NMDs. The data charting process involved extracting measurement properties of included PROMs, comprising validity, reliability, responsiveness, and interpretability information. The review identified 190 PROMs evaluated across 247 studies in individuals with NMDs. The majority of PROMs were disease specific. The physical functioning domain was most assessed. Validity was the most frequently investigated measurement property, with a limited number of PROMs sufficiently evaluated for a range of psychometric characteristics. There is a strong need for further research on the responsiveness and interpretability of PROMs and the development of PROMs on social functioning in NMD.

MCID and PASS in Knee Surgeries. Theoretical Aspects and Clinical RelevanceReferences.

The application and interpretation of patient-reported outcome measures (PROM), following knee injuries, pathologies, and interventions, can be challenging. In recent years, the literature has been enriched with metrics to facilitate our understanding and interpretation of these outcome measures. Two commonly utilized tools include the minimal clinically important difference (MCID) and the patient acceptable symptoms state (PASS). These measures have demonstrated clinical value, however, they have often been under- or mis-reported. It is paramount to use them to understand the clinical significance of any statistically significant results. Still, it remains important to know their caveats and limitations. In this focused report on MCID and PASS, their definitions, methods of calculations, clinical relevance, interpretations, and limitations are reviewed and presented in a simple approach.

Minimal Clinically Important Differences for Oxford, Constant, and University of California Los Angeles Shoulder Scores After Reverse Shoulder Arthroplasty to Allow Interpretation of Patient-Reported Outcome Measures and Future Statistical Power Analyses

To determine Minimal clinically important difference (MCID) for Constant-Murley Score (CMS), University of California Los Angeles (UCLA) Shoulder Score and Oxford Shoulder Score (OSS) after reverse shoulder arthroplasty. Patients were prospectively followed up between January 2011 and February 2020. Inclusion criteria was that of patients who underwent reverse shoulder arthroplasty for massive irreparable cuff tear, cuff tear arthropathy, and fractures, with and without prior cuff repair by a fellowship trained surgeon. Patients were assessed preoperatively and at 3, 6 and 12 months postoperatively. Functional outcome was assessed by the CMS, UCLA score, and OSS and the respectively MCIDs were determined using simple linear regression in consonance with patient satisfaction and expectation fulfilment. A total of one hundred and thirty-one patients were followed up for 12 months. The MCIDs at 3 months for CMS, UCLA and OSS were 7.2, 3.3 and 6.9 respectively. At 6 months, the MCIDs for CMS, UCLA and OSS were 6.6, 2.4 and 4.7 respectively. At 12 months, the MCIDs for CMS, UCLA and OSS are 9.3, 2.9 and 6.6 respectively. CMS, UCLA and OSS are valid scores to calculate MCID after Reverse Shoulder Arthroplasty and the MCID established in this study can be used for the interpretation of these scores to help in statistical power analysis for future studies.

How to Improve Interpretability of Patient-Reported Outcome Measures for Clinical Use: A Perspective on Measuring Abilities and Feelings.

Two general classes of concepts measured by patient-reported outcome measures (PROMs) are abilities and feelings. Over the past several decades, there has been a significant progress in measuring both. Nevertheless, current multi-item scales are subject to criticism related to scale length, score dimensionality, interpretability, cultural bias, and insufficient detail in measuring specific domains. To address some of these issues, the author offers an alternative perspective on how questions about abilities and feelings could be formulated. Abilities can be defined in terms of a relationship between the level of performance and the associated perception of difficulty, and represented graphically by an ability curve. For feelings, it may be useful to measure frequency and intensity jointly to determine the proportion of time in each level of intensity. The resultant frequency × intensity matrix can be presented as a bar graph. Empirical data to support the feasibility and validity of these approaches to PROM design are provided, potential advantages and limitations are discussed, and some future research avenues are suggested.

Does obesity lead to lower rates of clinically meaningful improvement or satisfaction after total hip arthroplasty? A propensity score-matched study.

Current literature lacks consensus regarding the impact of obesity on clinical outcomes of total hip arthroplasty (THA). The variability of results may reflect the lack of minimal clinically important difference (MCID) analysis, which helps to standardise the interpretation of patient-reported outcome measures (PROMs). We compared the PROMs, patient satisfaction and survivorship between obese and non-obese patients after THA. Prospectively collected registry data of 192 obese patients and 192 propensity score-matched controls who underwent primary THA at a single institution were reviewed. Clinical outcomes and satisfaction rates were assessed at 6 months and 2 years. Reoperations for surgical complications and revision rates were analysed. Obese patients had a significantly poorer Oxford Hip Score (OHS) at 6 months and WOMAC-Function at 2 years. However, there was no difference in overall WOMAC, WOMAC-Pain, WOMAC-stiffness, SF-36 mental and physical component summary (PCS). A similar proportion of patients in each group achieved the MCID for OHS, WOMAC and SF-36 PCS. At 2 years, 90.3% of obese patients and 91.7% of controls were satisfied (p = 0.755). At a mean follow-up of 9 years, there were 5 reoperations (2.6%) for surgical complications in the obese group and 1 (0.5%) in the control group; whereas 12 revisions (6.3%) were recorded in the obese group and 3 (1.6%) in the control group (p = 0.021). Despite a higher revision rate, obese patients undergoing THA may experience a similar level of clinical meaningful improvement and satisfaction as their non-obese counterparts. This study provides valuable prognostic information for obese patients and guides preoperative counselling.

Mind the methods of determining minimal important differences: three critical issues to consider

ObjectiveClinical trialists, meta-analysts and clinical guideline developers are increasingly using minimal important differences (MIDs) to enhance the interpretability of patient-reported outcome measures (PROMs). Here, we elucidate three critical issues of...

Using patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs) in routine head and neck cancer care: What do health professionals perceive as barriers and facilitators?

Patient-reported outcomes (PROs) are direct reports from patients about their health status. Patient-reported outcome measures (PROMs) are validated tools assessing PROs andcompleted by patients. Though commonly used in research, implementing PROMs into routine clinical care has been challenging. We aimed to examine health professionals' (HPs') perceptions of barriers and facilitators to PRO and PROM use in the routine care of head and neck cancer (HNC) patients. A custom survey was created, pilot-tested and disseminated to all HPs involved in the care of HNC patients in Western Sydney Local Health District, Australia. Participants were asked to rate the degree to which they believed the survey items were barriers or facilitators to routine PRO use by answering 'not at all', 'very little', 'quite a bit' and 'very much'. Of 129 HPs, 86% had never routinely used PROs. Key barriers perceived were low workplace awareness of PROs (73%), HPs' lack of knowledge on PRO use (63%) and lack of PROMs in patient preferred languages (63%). Insufficient time, staff and infrastructure to support routine PRO collection and non-integrated PROMs in patient electronic medical records were also highlighted. Top facilitators were time for PRO administration and interpretation (86%), clear definition of staff roles (84%) and automatic scoring and interpretation of PROMs (81%). This study highlighted key barriers and facilitators to PRO use in routine HNC patient care as perceived by HPs. The findings will be useful in guiding the successful and sustainable implementation of routine PRO collection in clinical settings.

Clinical Interpretation of the Neck Functional Status Computerized Adaptive Test

Clinical interpretation of patient-reported outcome measures is an essential step in patient-centered care. Interpretation of scores derived from the Neck Functional Status Computerized Adaptive Test (NFS-CAT) has not been studied. To (1) assess the reliability of point estimates and improvement scores, (2) determine thresholds of minimal clinically important improvement (MCII), and (3) develop a functional staging model to facilitate clinical interpretation of NFS-CAT scores. A secondary retrospective cohort analysis was performed using data from patients aged 14 to 89 years who started an episode of care for neck impairments during 2016-2017 and completed the NFS-CAT at admission. The reliability of point estimates and of improvement scores was derived from the NFS-CAT standard error of measurement. The MCII was estimated by combining distribution- and anchor-based approaches. A functional staging model was developed to describe clinical meaningfulness of the quantitative scores provided by the NFS-CAT. Of 250 741 patients who completed the NFS-CAT at admission (mean ± SD age, 54 ± 16 years; 65% female), 169±039 (67%) also completed the NFS-CAT at discharge. The standard error of measurement was stable across the measurement continuum, ranging from 3.7 to 3.9 NFS-CAT points. Minimal detectable improvement was 6.8 points at the 90% confidence level. The estimate of the MCII was 8.1 points, with more change points needed to achieve the MCII for patients with lower baseline scores. Large rates of functional staging change during treatment were observed, demonstrating responsiveness of the functional staging model. This study demonstrated how the NFS-CAT can be interpreted to better assist clinicians and patients with neck impairments during outpatient rehabilitation. Therapy, level 2b. J Orthop Sports Phys Ther 2019;49(12):875-886. Epub 10 Jul 2019. doi:10.2519/jospt.2019.8862.

PROMIS correlation with NDI and VAS measurements of physical function and pain in surgical patients with cervical disc herniations and radiculopathy.

The aim of this study was to compare the patient-reported outcome measures Neck Disability Index (NDI) and visual analog scale (VAS) with the Patient Reported Outcomes Measurement Information System (PROMIS) physical function (PF) and pain interference (PI) measures, respectively, and to determine their correlations in a surgical population longitudinally.Legacy outcome measures such as NDI and VAS are essential for analyzing treatments in spine surgery for cervical disc herniations with radiculopathy. Despite their usefulness, administrative burdens impose limits on completion of these measures. PROMIS was developed as a patient outcome measure in order to improve reporting of patient symptoms and function and to reduce administrative burden. Despite early positive results of PROMIS in orthopedics, NDI and VAS scores have not been compared with PROMIS scores in patients with cervical disc herniations with radiculopathy. Eighty patients undergoing surgery for cervical disc herniations with radiculopathy were included. All patients were treated at the same tertiary spine center. Patients were seen and PROMIS PF and PI, NDI, and VAS arm and neck pain scores were collected preoperatively and at 1 year postoperatively. Correlations between NDI, VAS, and PROMIS PF and PI were quantified using Pearson correlation coefficients. Two-tailed Student t-tests were used to demonstrate correlation significance, with alpha = 0.05. All 80 (100%) patients completed all preoperative questionnaires. Fifty-seven (72%) and 75 (94%) patients completed all questionnaires at baseline and at the 6-month and 1-year follow-ups, respectively. PROMIS PF and NDI scores demonstrated a strong negative correlation, with Pearson r values of -0.81, -0.77, and -0.75 at baseline, 6 months, and 1 year. PROMIS PI and VAS neck pain scores demonstrated a moderately positive correlation, with Pearson r values of 0.51, 0.61, and 0.6. PROMIS PI and VAS arm pain scores demonstrated a moderately positive correlation, with Pearson r values of 0.46, 0.47, and 0.45. PROMIS PF scores have a strong negative correlation with NDI scores at baseline and in the postoperative course in patients undergoing surgery for cervical disc herniations with radiculopathy. PROMIS PI scores have a moderately positive correlation with VAS neck and arm pain scores at baseline and in the postoperative course. Surgeons may factor these correlation results into the interpretation of patient-reported outcome measures in patients with cervical radiculopathy. Use of PROMIS PF and PI for this patient population may reduce administrative burden while providing reliable outcomes data.

Interpretation and use of patient-reported outcome measures through a philosophical lens.

As patient-reported outcome measures (PROMs) increasingly become key outcome indicators in healthcare, there has been growing concern about the potential negative consequences that could result when interpretations are being made to inform clinical and policy decisions. Therefore, we explored theoretical issues, assumptions, and consequences of using PROMs from a philosophical point of view. Our analysis of the literature was informed by Gadamerianhermeneutics, which emphasizes the dialectical processes that occur during interpretation, to provide insights as to how different users interpret and use standardized questions about health and quality of life. We structured our consideration according to three tenets of using PROMs: (1) the use of PROMs involves the interpretation of contextual elements; (2) interpretation of PROMs is an ongoing dialectical interaction; and (3) the use of PROMs involves openness and reflexivity. These findings suggest that hermeneutics provides a useful approach to examining the complexities of measuring patient-reported outcomes by attending to the perspectives of different users (e.g., patients, clinicians, administrators, and policy-makers)at the micro-, meso-, and macro-levels and the broader socio-historical and economic situation. Because PROMs can have different meanings and are used for different purposes, we propose that hermeneutics be used as a lens to ask reflexive questions about the problems of measurement and open a pluralistic dialogue with respect to the way we use PROMs and the interpretations we make of the findings that derive from our studies.

PROMIS Physical Function Correlation With NDI and mJOA in the Surgical Cervical Myelopathy Patient Population.

Retrospective review. To determine the correlation of Patient-Reported Outcomes Measurement Information System (PROMIS) physical function with Neck Disability Index (NDI) and Modified Japanese Orthopedic Association (mJOA) scores in the surgical cervical myelopathy patient population. Outcome measures such as NDI and mJOA are essential for analyzing treatments for cervical myelopathy. Administrative burdens impose limits on completion of these measures. The PROMIS group developed an outcome measure to improve reporting of patient symptoms and function and to reduce administrative burden. Despite early success, NDI and mJOA have not been compared with PROMIS in patients with cervical myelopathy. This study determines the correlation of NDI and mJOA with PROMIS in surgical patients with cervical myelopathy. A total of 60 patients with cervical myelopathy undergoing surgery were included. PROMIS, NDI, and mJOA were collected preoperatively, and in the first 6 months postoperatively. Correlations between NDI, mJOA, and PROMIS were quantified using Pearson correlation coefficients. Students t tests were used to test significance. All 60 (100%) of patients completed preoperative questionnaires. Fifty-five (92%) of patients completed initial follow-up questionnaires within the first 6 months. PROMIS physical function and NDI demonstrated a strong negative correlation at baseline and in initial follow-up (R = -0.69, -0.76). PROMIS and mJOA demonstrated a strong positive correlation at baseline and in initial follow-up (R = 0.61, 0.72). PROMIS physical function has a strong negative correlation with NDI and a strong positive correlation with mJOA at baseline and in the early postoperative course in patients undergoing surgery for cervical myelopathy. Surgeons may factor these outcomes into the delivery and interpretation of patient-reported outcome measures in this population. Use of PROMIS may improve completion of outcome measures in the office and reduce administrative burden while still providing reliable outcomes data. 3.

Using Patient-Reported Measures in Dialysis Clinics.

Patient-reported outcome measures (PROMs), including patient-reported outcomes (PROs), are one of two primary sources of data about patients on dialysis ([1][1]); the other is biologically based patient data. The Food and Drug Administration definition of a PRO is “any report coming from patients

Symptom clusters for revising scale membership in the analysis of prostate cancer patient reported outcome measures: a secondary data analysis of the Medical Research Council RT01 trial (ISCRTN47772397)

PurposeTo investigate the role of symptom clusters in the analysis and utilisation of patient reported outcome measures (PROMs) for data modelling and clinical practice. To compare symptom clusters with scales, and to explore their value in PROMs interpretation and symptom management.MethodsA dataset called RT01 (ISCRTN47772397) of 843 prostate cancer patients was used. PROMs were reported with the University of California, Los Angeles Prostate Cancer Index (UCLA-PCI). Symptom clusters were explored with hierarchical cluster analysis (HCA) and average linkage method (correlation > 0.6). The reliability of the Urinary Function Scale was evaluated with Cronbach’s Alpha. The strength of the relationship between the items was investigated with Spearman’s correlation. Predictive accuracy of the clusters was compared to the scales by receiver operating characteristic (ROC) analysis. Presence of urinary symptoms at 3 years measured with the late effects on normal tissue: subjective, objective, management tool (LENT/SOM) was an endpoint.ResultsTwo symptom clusters were identified (urinary cluster and sexual cluster). The grouping of symptom clusters was different than UCLA-PCI Scales. Two items of the urinary function scales (“number of pads” and “urinary leak interfering with sex”) were excluded from the urinary cluster. The correlation with the other items in the scale ranged from 0.20 to 0.21 and 0.31 to 0.39, respectively. Cronbach’s Alpha showed low correlation of those items with the Urinary Function Scale (0.14–0.36 and 0.33–0.44, respectively). All urinary function scale items were subject to a ceiling effect. Clusters had better predictive accuracy, AUC = 0.70 –0.65, while scales AUC = 0.67–0.61.ConclusionThis study adds to the knowledge on how cluster analysis can be applied for the interpretation and utilisation of PROMs. We conclude that multiple-item scales should be evaluated and that symptom clusters provide a study-specific approach for modelling and interpretation of PROMs.

Recovery, responsiveness and interpretability of patient-reported outcome measures after surgery for Dupuytren's disease.

II.

Patient-reported outcome measures in arthroplasty registries

The International Society of Arthroplasty Registries (ISAR) Steering Committee established the Patient-Reported Outcome Measures (PROMs) Working Group to convene, evaluate, and advise on best practices in the selection, administration, and interpretation of PROMs and to support the adoption and use of PROMs for hip and knee arthroplasty in registries worldwide. The 2 main types of PROMs include generic (general health) PROMs, which provide a measure of general health for any health state, and specific PROMs, which focus on specific symptoms, diseases, organs, body regions, or body functions. The establishment of a PROM instrument requires the fulfillment of methodological standards and rigorous testing to ensure that it is valid, reliable, responsive, and acceptable to the intended population.A survey of the 41 ISAR member registries showed that 8 registries administered a PROMs program that covered all elective hip or knee arthroplasty patients and 6 registries collected PROMs for sample populations; 1 other registry had planned but had not started collection of PROMs. The most common generic instruments used were the EuroQol 5 dimension health outcome survey (EQ-5D) and the Short Form 12 health survey (SF-12) or the similar Veterans RAND 12-item health survey (VR-12). The most common specific PROMs were the Hip disability and Osteoarthritis Outcome Score (HOOS), the Knee injury and Osteoarthritis Outcome Score (KOOS), the Oxford Hip Score (OHS), the Oxford Knee Score (OKS), the Western Ontario and McMaster Universities Arthritis Index (WOMAC), and the University of California at Los Angeles Activity Score (UCLA).

Patient and Public Involvement in Patient-Reported Outcome Measures

This paper considers the potential for collaborative patient and public involvement in the development, application, evaluation, and interpretation of patient-reported outcome measures (PROMs). The development of PROMs has followed a well trodden methodological path, with patients contributing as research subjects to the content of many PROMs. This paper argues that the development of PROMs should embrace more collaborative forms of patient and public involvement with patients as research partners in the research process, not just as those individuals who are consulted or as subjects, from whom data are sourced, to ensure the acceptability, relevance, and quality of research. We consider the potential for patients to be involved in a much wider range of methodological activities in PROM development working in partnership with researchers, which we hope will promote paradigmal evolution rather than revolution.

Interpretation of patient-reported outcome measures for varicose vein surgery

Since 2009 the National Health Service (NHS) has been collecting patient-reported outcome measures (PROMs) following varicose vein interventions. The objective of this manuscript was to interrogate the one-year PROMs data with respect to varicose vein intervention and to discuss its potential impact on the provision of service. We interrogated the one-year PROMs data with respect to potential impact on the provision of service. In total, 37,521 varicose vein operations were performed during the study period (1 April 2009-30 April 2010). A total of 15,808 preoperative questionnaires were completed and returned and 12,509 were linked to Hospital Episode Statistics episodes. A total of 8127 postoperative questionnaires were completed and linked to the preoperative questionnaires. For the EuroQuol (EQ) 5D questionnaire average preoperative score across the completed data-set was 0.773. The postoperative health gain was 0.094. Fifty-three percent of patients had improved postoperative scores, 33% reported no change, while 14% reported a reduction in their postoperative EQ-5D score. Pain/discomfort was the only domain where patients reported any negative symptoms; 72% (5390) reported pain/discomfort preoperatively and 37% (2804) postoperatively. In total, 62.6% (4685) reported no pain/discomfort following surgery A total of 7167 complete, linked and eligible data-sets were observed for the Aberdeen Varicose Vein Questionnaire (AVVQ). The average preoperative score was 18.75. The average postoperative score was 10.76. This represented a reduction in symptom scores of one-half following intervention. The lowest improvements were witnessed in patients with the lowest preoperative scores (least severe symptoms). Additional postoperative questions highlighted the improvements conferred from varicose vein surgery with 90.3% of patients reporting an improvement in their problems from varicose veins following surgery and 85% describing their operative results as excellent, very good or good. These data have shown variable improvements following venous interventions. PROMs are likely to have significant implications for health care in the NHS on a number of levels including provision of funding and future planning of services.