Condition-specific Outcome Measures Research Articles

Empowered or challenged? The dual impact of condition-specific electronic Patient-Reported Outcome Measures in the person-centred care of women with breast cancer: A qualitative study

Empowered or challenged? The dual impact of condition-specific electronic Patient-Reported Outcome Measures in the person-centred care of women with breast cancer: A qualitative study

Cross-Cultural Adaptation and Validation of the Thai Version of the Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain and Osteoarthritis (KOOS-PF).

The Knee injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF) is a condition-specific patient-reported outcome measure that is used to evaluate patients with patellofemoral pain. To translate the KOOS-PF into the Thai language, to make necessary adaptations to a Thai cultural context, and to assess the measurement properties of the Thai version of the KOOS-PF (TH-KOOS-PF) using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Cohort study (diagnosis); Level of evidence, 3. This study was conducted between December 2021 and May 2023. Language translation of the KOOS-PF was performed according to guidelines for the cross-cultural adaptation of self-report measures. Eligible participants aged 18 to 50 years were asked to complete various patient-reported outcome measures including the TH-KOOS-PF at 3 time points: baseline, 2 weeks after baseline for test-retest reliability analysis, and 2 months after baseline for responsiveness assessment. The KOOS-PF was successfully translated and culturally adapted to create the TH-KOOS-PF. A total of 86 participants (mean age, 37.0 ± 8.1 years; 59.3% female) with patellofemoral pain participated in the validation process. Construct validity of the TH-KOOS-PF was demonstrated by confirmation of all a priori hypotheses. The standardized Cronbach alpha coefficient was 0.88 (95% CI, 0.83-0.91), which indicated good internal consistency. Test-retest reliability was high, with an intraclass correlation coefficient of 0.87 (95% CI, 0.77-0.92). The TH-KOOS-PF demonstrated good responsiveness, as evidenced by all predefined hypotheses' being confirmed, and there were no floor or ceiling effects. Using an anchor-based approach, the minimal clinically important difference was 11.6 points. The results of this study revealed the TH-KOOS-PF to be a valid, reliable, and responsive tool for assessing Thai patients with patellofemoral pain. The TH-KOOS-PF will be useful in both clinical and research settings.

English Translation and Cultural Adaptation of the Knee Numeric-Entity Evaluation Score (KNEES-ACL): A Condition-Specific Patient-Reported Outcome Measure for Anterior Cruciate Ligament Injuries

Background: The Knee Numeric-Entity Evaluation Score (KNEES-ACL) is a 41-item condition-specific patient-reported outcome measure (PROM) that was developed for patients with an anterior cruciate ligament (ACL) deficiency and patients after ACL reconstruction. This measure is intended to be used for longitudinal clinical studies. The KNEES-ACL has demonstrated face and content validity and superior responsiveness compared with other PROMs commonly used in patients with an ACL injury. However, this PROM was developed in Danish and has not been appropriately translated and culturally adapted into North American English. Purpose: To translate and culturally adapt the KNEES-ACL from Danish to North American English. Study Design: Cross-sectional study. Methods: Translation from Danish to English and cultural adaptation to a North American context were performed according to the dual panel method. First, the Danish KNEES-ACL was translated by a bilingual panel, which provided multiple English wording options for each item. Second, an English lay panel focus group was formed to determine the wording for each item that best reflected everyday spoken language. Finally, individual think-aloud cognitive interviews were conducted with patients after an ACL injury to evaluate the relevance, comprehensiveness, and comprehensibility of the PROM content and questions. Repeated modifications and testing were performed until a final English version of the KNEES-ACL was constructed. Results: Participants in the lay panel focus group were able to reach unanimous decisions for each of the 41 items. Further changes to 17 items were made after 8 think-aloud interviews with patients with ACL injuries at various time points to ensure that items were relevant and being interpreted consistently among different types of patients. The final KNEES-ACL consisted of 6 domains: Problems with Daily Activities, Mental Impact, Stability, Strength and Control, Pain, and Sport and Physical Activity. Conclusion: The English KNEES-ACL for patients with ACL injuries has undergone appropriate translation and cultural adaptation using established dual panel and cognitive interviewing methods in the population of interest. The psychometric properties of the English KNEES-ACL will likely mirror those established with the Danish version. However, direct validation of the psychometric properties of the English version would be beneficial before widespread use.

Responsiveness of the condition-specific Outcome measures for VAscular MAlformations (OVAMA) questionnaire to measure symptoms and appearance in patients with vascular malformations.

Evidence-based guidelines for the treatment of vascular malformations (VMs) are not readily available, possibly due to the diversity in methods used to evaluate treatment efficacy in clinical research, complicating the aggregation and comparison of study results. The Outcome measures for VAscular MAlformations (OVAMA) questionnaire was developed to measure uniformly symptoms and appearance (i.e. condition-specific core outcome domains) in patients with VMs. However, the OVAMA questionnaire needs to be responsive to changes in these constructs in order to assess whether disease status has changed since treatment. To assess the responsiveness of the OVAMA questionnaire in patients with VMs. In a prospective longitudinal study, patients completed the OVAMA questionnaire at baseline and at 8 weeks after treatment or a watchful waiting policy. Additionally, patients completed global rating of change (GRC) scales at follow-up. Responsiveness was evaluated following the criterion approach of testing predefined hypotheses about expected relationships between the OVAMA questionnaire and GRC scales measuring the same constructs. The OVAMA questionnaire was considered responsive if ≥ 75% of the hypotheses were confirmed. Between July 2020 and September 2022, 89 patients were recruited in a vascular anomaly centre in the Netherlands; 63 patients completed the questionnaires at baseline and follow-up. In total, 15 constructs of the OVAMA questionnaire were assessed for 5 hypotheses. Of these 75 hypotheses, 63 (84%) were confirmed, providing evidence that the OVAMA questionnaire is responsive to change. Our study found convincing evidence that the OVAMA questionnaire is responsive to changes in symptoms and appearance in patients with VMs. In addition to determining a baseline for symptoms and appearance, the OVAMA questionnaire can now be used to evaluate the effect of treatment from a patient's perspective. The responsive OVAMA questionnaire allows for uniform evaluation and comparison of the effects of treatment on the condition-specific core outcome domains, tackling heterogeneity in outcome measurement and improving the clinical research of VMs.

P.069 Development of a streamlined multi-disciplinary care pathway for compression neuropathies

Background: Care for patients with compression neuropathies (carpal tunnel syndrome, ulnar neuropathy) is often fragmented, uncoordinated, and slow. Patients go through multiple steps (neurology consultation, nerve testing, ultrasound, splints, injection, surgical opinion, surgery) with waits between each step. We used a Value-Based Health Care (VBHC) model to develop a multidisciplinary clinic with a novel care pathway. Methods: A Shared Care initiative supported the development of an Integrated Practice Unit (IPU). Key multidisciplinary team members were identified. Participants attended a curated three part VBHC workshop. Process mapping enabled identification of efficiencies. Results: 14 team members participated in the workshops. Condition specific outcome measures were identified (Boston CTS measure, 10-point touch, MRC strength and pain scale) and will be collected longitudinally. Criteria and clinical pathways were developed for mild, moderate, and severe carpal tunnel syndrome. Resource materials for patients and providers were developed. Conclusions: A VBHC framework supported development of a novel clinic for compression neuropathy. Responsibility for the full cycle of care rests with the IPU. Systematically tracking functional outcome measures enables quality improvement. By streamlining the patient journey and substantially reducing wait times between steps, the new care pathway reduces complexity and improve outcomes. Evaluation of impact if this new clinical model is ongoing.

Psychometric analysis of the modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) in a prospective multicentre study

BackgroundLong COVID (LC) is a novel multisystem clinical syndrome affecting millions of individuals worldwide. The modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) is a condition-specific patient-reported outcome measure designed for assessment...

Long COVID Clinical Severity Types Based on Symptoms and Functional Disability: A Longitudinal Evaluation.

Background: Long COVID (LC) is a multisystem clinical syndrome with functional disability and compromised overall health. Information on LC clinical severity types is emerging in cross-sectional studies. This study explored the pattern and consistency of long COVID (LC) clinical severity types over time in a prospective sample. Methods: Participants with LC completed the condition-specific outcome measure C19-YRSm (Yorkshire Rehabilitation Scale modified version) at two assessment time points. A cluster analysis for clinical severity types was undertaken at both time points using the k-means partition method. Results: The study included cross-sectional data for 759 patients with a mean age of 46.8 years (SD = 12.7), 69.4% females, and a duration of symptoms of 360 days (IQR 217 to 703 days). The cluster analysis at first assessment revealed three distinct clinical severity type clusters: mild (n = 96), moderate (n = 422), and severe (n = 241). Longitudinal data on 356 patients revealed that the pattern of three clinical severity types remained consistent over time between the two assessments, with 51% of patients switching clinical severity types between the assessments. Conclusions: This study is the first of its kind to demonstrate that the pattern of three clinical severity types is consistent over time, with patients also switching between severity types, indicating the fluctuating nature of LC.

Cross-Cultural Validation of the Thai Oral Health Impact Profile for Temporomandibular Disorders

ObjectivesThe Oral Health Impact Profile for Temporomandibular Disorders (OHIP-TMDs) is a validated condition-specific outcome measure to help guide decision-making in the management of the condition. There is no Thai version of OHIP-TMDs, and therefore the original English version needs cross-cultural adaptation translation, and validation with a Thai population to reduce the anomalies due to language and cultural differences. This study aimed to develop the Thai-language version of OHIP-TMDs, perform a cross-cultural adaptation to Thailand, and assess its content validity, internal consistency, reliability, and construct validity. MethodsThe original English version of OHIP-TMDs was forward and backward translated into Thai language using the International Network for Orofacial Pain and Related Disorders methodology (INfORM) protocol for cross-cultural adaptation. The Content Validity Index (CVI) was performed by 5 orofacial pain (OFP) specialists to establish content validity. The OHIP-TMDs-T was then tested in 2 groups of Thai dental patients including 110 TMD patients and 110 control participants. The internal reliability and test-retest reliability (n = 30) were investigated in the TMD group using Cronbach alpha coefficient and intraclass correlation coefficient (2-way mixed effect model), respectively. The difference in OHIP-TMDs-T score between the TMD group and control group was investigated for known group validity. ResultsCronbach alpha and intraclass correlation coefficients were 0.942 and 0.797, respectively. The CVI collected from the OFP specialists was 0.92. There was a statistical difference in the OHIP-TMDs-T overall score between the TMD group (95% CI, 40–46) and control group (95% CI, 2.0–3.4) (Z = 9.060, r = 1, P < .001). ConclusionsThe OHIP-TMDs-T is a valid and reliable tool for evaluating the quality of life and the impact on oral health in Thai patients with TMD.

What Aspects of Quality of Life are Important from Palliative Care Patients' Perspectives? A Framework Analysis to Inform Preference-Based Measures for Palliative and End-of-Life Settings.

Preference-based outcome measures are commonly applied in economic analyses to inform healthcare resource allocation decisions. Few preference-based outcome measures have been specifically developed for palliative and end-of-life settings. This study aimed to identify which quality-of-life domains are most important to Australians receiving specialised palliative care services to help determine if the development of a new condition-specific preference-based outcome measure is warranted. In-depth face-to-face interviews were conducted with 18 participants recruited from palliative care services in South Australia. Data were analysed using a framework analysis drawing on findings from a systematic review of international qualitative studies investigating the quality-of-life preferences of patients receiving palliation (domains identified included cognitive, emotional, healthcare, personal autonomy, physical, preparatory, social, spiritual). Participants identified missing or irrelevant domains in the EQ-5D and QLU-C10D questionnaires and ranked the importance of domains. A priori domains were refined into cognitive, environmental, financial, independence, physical, psychological, social and spiritual. The confirmation of the eight important quality-of-life domains across multiple international studies suggests there is a relatively high degree of convergence on the perspectives of patients in different countries. Four domains derived from the interviews are not covered by the EQ-5D and QLU-C10D (cognitive, environmental, financial, spiritual), including one of the most important (spiritual). Existing, popular, preference-based outcome measures such as the EQ-5D do not incorporate the most important, patient-valued, quality-of-life domains in the palliative and end-of-life settings. Development of a new, more relevant and comprehensive preference-based outcome measure could improve the allocation of resources to patient-valued services and have wide applicability internationally.

Further psychometric validation and test-retest reproducibility of the WOUND-Q.

WOUND-Q is a condition-specific patient-reported outcome measure developed for all types of chronic wounds, located anywhere on the body. To establish reliability and validity of a patient-reported outcome measure, multiple pieces of evidence are required. The purpose of this study was to examine the measurement properties of 9 of the 13 WOUND-Q scales and perform a test-retest reproducibility study in an international sample. In August 2022, we invited members of an international online community (Prolific.com) with any type of chronic wound to complete a survey containing the WOUND-Q scales, the Wound-QoL and EQ-5D. A test-retest survey was performed 7 days after the first survey. It was possible to examine the reliability and validity of eight of the nine WOUND-Q scales by Rasch Measurement Theory (RMT). To examine test-retest reproducibility intraclass correlation coefficients (ICCs), the standard error of the measurement and the smallest detectable change were calculated. In total, 421 patients from 22 different countries with 11 different types of chronic wounds took part in this study. Our analyses provided further evidence of the reliability and validity of the scales measuring wound characteristics (assessment, drainage, smell), health-related quality of life (life impact, psychological, sleep, social) and wound treatment (dressing).

Assessing the validity and responsiveness of a generic preference quality of life measure in the context of posttraumatic stress disorder

PurposeThere is limited research exploring the usefulness of generic preference-based quality of life (GPQoL) measures used to facilitate economic evaluation in the context of posttraumatic stress disorder (PTSD). The aim of the current study was to explore the validity and responsiveness of a common GPQoL measure (Assessment of Quality of Life 8 Dimension [AQoL-8D]) in relation to a PTSD condition-specific outcome measure (Posttraumatic Stress Disorder Checklist for the DSM-5 [PCL-5]).MethodThis aim was investigated in a sample of individuals (N = 147) who received trauma-focused cognitive-behavioural therapies for posttraumatic stress disorder. Convergent validity was investigated using spearman’s correlations, and the level of agreement was investigated using Bland–Altman plots. Responsiveness was investigated by exploring the standardised response means (SRM) from pre-post-treatment across the two measures, which allow the comparison of the magnitude of change between the measures over time.ResultsCorrelations between the AQoL-8D (dimensions, utility and summary total scores) and the PCL-5 total score ranged from small to large and agreement between the measures was considered moderate to good. While SRMs were large for the AQoL-8D and PCL-5 total scores, the SRM for the PCL-5 was nearly double that of the AQoL-8D.ConclusionOur findings demonstrate that the AQoL-8D has good construct validity but present preliminary evidence that economic evaluations using only GPQoL measures may not fully capture the effectiveness of PTSD treatments.

Patient-reported outcomes and patient-reported outcome measures in liver transplantation: a scoping review.

Generic or condition-specific Patient-reported Outcome Measures (PROMs) are used to measure physical, mental, and social aspects of health to promote patient-centered care. This scoping review aims to identify and summarize generic and condition-specific PRO domains and PROMs that have been assessed and used in liver transplant (LT) candidates and recipients. We searched Medline, Embase, Cochrane Database of Systematic Reviews and Register of Trials, PsychInfo, and CINAHL from inception to 08/26/2020. Included studies addressed a PRO or PROM in LT candidates or recipients. After screening, 341 studies yielded 189 unique PRO domains. Mental health domains (depression, anxiety, and guilt) were most frequently assessed, followed by domains of physical and social health. Fifty-one generic and three condition-specific unique PROMs were identified, with only 13% (n = 45) of studies including condition-specific tools. The most frequent PROMs were the SF-36, Nottingham Health Profile, Hospital Anxiety and Depression Scale, followed by the Liver Disease Quality of Life (LDQoL). Very few studies used transplant-specific PROMs, which may partly be related to the scarcity of LT-specific instruments. We will use these results in future qualitative research to identify PROs and PROMs to build an electronic PROM toolkit to facilitate patient-centered LT care.

Condition-Specific Oral Health-Related Quality of Life (CS-OHRQoL) measures in Orthodontics- A Narrative Review

Outcomes pertaining to orthodontics can be either ‘disease’ outcome or ‘treatment’ outcome. The scales used for outcome assessment are usually the same for both and can be classified as generic or condition-specific. Generic scales are used in general for a variety of clinical conditions in dentistry, whereas condition-specific scales are used for specific problems like malocclusion. Due to the peculiar nature of orthodontic problems that do not fall into the definition of a disease, generic scales are of little use and condition-specific ones are recommended. The present article aims to provide a summary of the available condition-specific patient-reported outcome measures in orthodontics and perform a critical analysis of the same.

Design of a treatment satisfaction measure for patients undergoing varicose vein treatment: Venous Treatment Satisfaction Questionnaire (VenousTSQ).

Established condition-specific patient-reported outcome measures for varicose veins are limited to the measurement of health status and function. A treatment satisfaction measure is needed to understand patient satisfaction with different treatment options. The aim of this study was to design a Venous Treatment Satisfaction Questionnaire (VenousTSQ) that would be ready for large-scale data collection and psychometric evaluation. Relevant items were selected from the -TSQ Item Library and new items were designed where necessary. A draft VenousTSQ was prepared using the existing AneurysmTSQ as a template. Fifteen interviews were conducted from 4 days to 16 months after the procedure. The interviews were designed to elicit important sources of satisfaction or dissatisfaction before completion of draft questionnaires. The VenousTSQ drafts were modified between sets of interviews until no further changes were required. The final VenousTSQ consists of two questionnaires: VenousTSQ early (VenousTSQe) and VenousTSQ status (VenousTSQs). Items that need be asked only once are in the VenousTSQe, whereas those that can usefully be asked more than once are in the VenousTSQs. Of the 16 unique items forming the VenousTSQ, 12 were from the -TSQ Item Library. Only 1 of these 12 required significant modification. The VenousTSQ represents a condition-specific psychological outcome measure for varicose veins, enabling patient satisfaction or dissatisfaction with such treatments to be measured. Large-scale data collection is under way to establish optimal scoring, quantitative validity, and reliability of the VenousTSQ.

LOng COvid Multidisciplinary consortium Optimising Treatments and servIces acrOss the NHS (LOCOMOTION): protocol for a mixed-methods study in the UK

IntroductionLong COVID, a new condition whose origins and natural history are not yet fully established, currently affects 1.5 million people in the UK. Most do not have access to specialist...

Long-Term Complications and Patient-Reported Outcomes After Alloplastic Breast Reconstruction.

The most widely used method for breast reconstruction in Taiwan is alloplastic breast reconstruction, and traditionally, it can be categorized into immediate or delayed, single-stage or 2-stage procedures. We evaluated clinical outcomes and analyzed patients' self-reported satisfaction and quality of life after alloplastic breast reconstruction based on a previous preliminary study. The patients who underwent primary alloplastic breast reconstruction after mastectomy were recruited in 2006 to 2020 at a single institute in Taiwan. The assessment of clinical outcomes was conducted by retrospective chart review and risk analysis. The patients also completed the BREAST-Q, a condition-specific patient-reported outcome measure, at least 6 months after treatment. A total of 237 patients with 247 reconstructed breasts were enrolled in this study. The demographics showed that 205 (83%) were reconstructed using a 2-stage tissue expander-based procedure and 42 (17%) were 1-stage direct-to-implant reconstructions. The mean follow-up time was 79.5 months. The clinical assessment revealed that the overall complication rate was 34%, with infection being the most common (21 patients; 8%). According to risk analysis, smoking (odds ratio, 7.626; 95% confidence interval, 1.56-37.30; P = 0.012), and nipple-sparing mastectomy (odds ratio, 3.281; 95% confidence interval, 1.54-6.99; P = 0.002) were significant risk factors for overall complications. The questionnaire response rate was 38% (94 of 247), at least 6 months after treatment. The total mean score was 69.78. At a single institute in Taiwan from 2006 to 2020, alloplastic breast reconstruction, either single- or 2-stage, have acceptable complication rate and good postoperative satisfaction based on patient-reported outcomes. Both patient- and surgery-related factors presented as significant risk factors. Precise patient selection and comprehensive discussion between the patient and physician may play the important role to achieve optimal aesthetic outcomes.

Psychometric Validation of the CLEFT-Q Patient Reported Outcome Measure: A Prospective Study to Examine Cross-Sectional Construct Validity.

CLEFT-Q is a condition-specific patient-reported outcome measure (PROM) for patients with cleft lip and/or palate (CL/P). The aim of this study was to examine the cross-sectional construct validity of the CLEFT-Q scales. Construct validity was assessed through a prospective study that tested hypotheses regarding correlations of scores with other PROMs that measure related constructs. Seven cleft centres in Canada, the USA, and UK were involved. Patients were aged eight to 29 years with CL/P. Before undergoing rhinoplasty, orthognathic, cleft lip scar revision, and alveolar bone graft, participants were asked to complete the following PROMs: CLEFT-Q (9 scales), Child Oral Health Impact Profile (socio-emotional subscale) and Cleft Hearing Appearance and Speech Questionnaire (features 1 subscale). The correlation coefficients examining the relationship between the scales were the main outcome measures. Correlations (Spearman) were calculated and interpreted as follows: <0.3 weak, 0.30 to 0.50 moderate, ≥0.50 strong. Participants (n = 177) were mostly male (61%) and aged between eight and 11 years (42%). Overall, 38 of 52 (73%) hypotheses tested were supported. More specifically, 20 of 26 (77%) hypotheses about correlations between the appearance scales were supported, two of three (67%) hypotheses about correlations between the health-related quality of life scales were supported, and 16 of 23 (70%) hypotheses about correlations between the appearance and health-related quality of life scales were supported. Cross-sectional construct validity of the CLEFT-Q scales adds further evidence of the psychometric properties of this instrument.

Concurrent validity and precision of the thumb disability examination (TDX) in first carpometacarpal osteoarthritis

Study DesignA descriptive psychometric study of precision and concurrent validity of the Thumb Disability Examination (TDX). IntroductionThumb carpometacarpal osteoarthritis (CMC OA) is a painful joint condition impacting the functionality of the hand. Therapists use patient-reported outcome measures to evaluate change in disability and symptomology in response to interventions. The TDX is the only condition-specific outcome measure for persons with thumb CMC OA. Its responsiveness, test-retest reliability and concurrent validity with the DASH are published, yet it's precision and concurrent validity with a hand-region-specific tool has not yet been established. Purpose of the StudyWe aimed to determine the precision and concurrent validity of the TDX with a region-specific outcome measure in people with thumb CMC OA. MethodsSixteen individuals with a medical diagnosis of CMC OA or a positive pressure-shear test completed the TDX across two visits and the Brief Michigan Hand Questionnaire (bMHQ) at the initial visit. The second visit was 7 to 21 days after the first. Self-administration of the TDX and bMHQ were observed by a licensed occupational therapist. ResultsAcross total and subscale scores of the TDX, standard error of measurement (SEM) values are used to indicate the precision of tool and demonstrate how confident a user can be that change in score exceeds the error inherent to the tool. Minimal detectable change percentage (MDC%) values for the TDX are acceptable (<30%). The TDX demonstrated high concurrent validity with the bMHQ (rs = -0.733; P = .001). DiscussionPrecision of the TDX is acceptable and the concurrent validity of the TDX with a commonly used region-specific scale is high. The study was limited by a small, demographically homogeneous sample due to difficulty in recruitment. ConclusionsThe TDX is a precise and valid outcome measure for individuals having a clinical diagnosis or indications of having thumb CMC OA.

A Comparison of Nerve-Specific, Condition-Specific, and Upper Extremity-Specific Patient-Reported Outcome Measures in Patients With Carpal and Cubital Tunnel Syndrome

Arm-, region-, tissue-, and condition-specific patient-reported outcome measures (PROMs) are available to address idiopathic mononeuropathy. This study compared PROMs with varying specificities in patients with idiopathic neuropathy of the upper extremity with respect to correlations with each another, sources of variation in scores, and floor and ceiling effects. One hundred fifty patients (130 with carpal tunnel syndrome, 30 with cubital tunnel syndrome, and 10 with both conditions) completed a nerve-specific PROM (Impact of Hand Nerve Disorders), a condition-specific PROM (Boston Carpal Tunnel Syndrome Questionnaire and/or Patient-Rated Ulnar Nerve Evaluation), and an upper extremity-specific PROM (Patient-Reported Outcomes Measurement Information System Physical Function Upper Extremity 7). We also gathered demographic and condition-related data (side, electrodiagnostic studies present, muscle atrophy, static loss of sensibility), and patients completed questionnaires measuring self-efficacy, kinesiophobia, and symptoms of depression. Correlation of the PROMs with each another and factors accounting for their variation were assessed, as well as the number of items to complete, time to complete, and floor and ceiling effects. Pearson correlations between PROMs were moderate to strong (0.56-0.90). Self-reported symptoms of depression were best able to account for the variations in symptom intensity and activity intolerance on all PROMs (adjusted R2 between 0.09 and 0.31). The Impact of Hand Nerve Disorders is a long questionnaire and took the most time to complete. All instruments had comparable floor effects; Patient-Reported Outcomes Measurement Information System Physical Function Upper Extremity had a ceiling of effect of 16%. This study adds to the evidence that specific and general PROMs correlate with each another, perhaps in part through their correlation with mental health. Based on this line of evidence and pending testing of potentially greater responsiveness in specific settings, we prefer to use a single simple, brief, and general PROM to quantify symptom intensity and activity intolerance for both routine patient care and research. Prognostic II.

Construct Validity and Validity to Change of the Patient-Specific Functional Scale in Patients with Shoulder and Low Back Pain: A Clinimetric Study

Background: Patient-specific and condition-specific measures are widely used in clinical practice and research to measure disability or change over time. While condition-specific outcome measures comprise a range of restrictions generally relevant for all patients, the Patient-Specific Functional Scale measures restrictions chosen by the individual patient. Objectives: Based on the hypothesis that patient-specific and conditionspecific scales deliver comparable results when used on group level. The aim of this study was to test for floor and ceiling effects, to evaluate construct validity and validity to change of the Patient-Specific Functional Scale when compared to condition-specific outcome measures. For this purpose, two datasets from patients with shoulder pain and low back pain were analyzed. Methods: Patient-Specific Functional Scale scores were compared to the Shoulder Pain and Disability Index and the Roland Morris Disability Questionnaire at 4 time-points using stem-and-leaf-plots and correlations using Pearson’s r. Hypothesis-driven correlation levels for data interpretation were predefined, with r ≥0.75=high, r ≥0.5=moderate, r ≥0.25=low. Results: Patient-Specific Functional Scale floor effects were comparable to condition-specific outcome measures in both samples. At none of the timepoints did the Patient-Specific Functional Scale correlate with the conditionspecific outcome measures in the expected manner. Conclusion: Hypotheses regarding expected ranges of correlation between the Patient-Specific Functional Scale and the condition-specific outcome measures for construct validity and validity to change were not met. While the use of the Patient-Specific Functional Scale in a clinical context has its advantages, the measure is not recommended for group-level evaluations.