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Patient-Reported Outcomes Measurement Information System (PROMIS) instruments among individuals with symptomatic knee osteoarthritis: a cross-sectional study of floor/ceiling effects and construct validity.

ABSTRACT: The psychometric properties of Patient Reported Outcomes Measurement Information System (PROMIS) instruments have been explored in a number of general and clinical samples. No study, however, has evaluated the psychometric function of these measures in individuals with symptomatic knee osteoarthritis (KOA). The aim of this project was to evaluate the construct (structural) validity and floor/ceiling effects of four PROMIS measures in this population.We conducted a secondary analysis of baseline data from a randomized trial comparing Tai Chi and physical therapy. Participants completed four PROMIS static short-form instruments (i.e., Anxiety, Depression, Physical Function, and Pain Interference) as well as six well-validated (legacy) measures that assess pain, function, and psychological health. We calculated descriptive statistics and percentages of participants scoring the minimum (floor) and maximum (ceiling) possible scores for PROMIS and legacy measures. We also estimated the association between PROMIS scores and scores on legacy measures using Spearman's rank correlations coefficients.Data from 204 participants were analyzed. Mean age of the sample was 60 years; 70% were female. The PROMIS Anxiety and Depression had floor effects with 17 and 24% of participants scoring the minimum, respectively. PROMIS Anxiety and Depression scores had strongest associations with general mental health, including stress (Perceived Stress Scale, r???0.65) and depression (Beck Depression Index-II, r?=?0.70). PROMIS Pain Interference scores correlated most strongly with measures of whole body pain (Short-Form 36 Bodily Pain, r?=?-0.73) and physical health (Short-Form 36 Physical-Component Summary, r?=?-0.73); their correlations were lower with other legacy measures, including with the WOMAC knee-specific pain (r?=?0.47). PROMIS Physical Function scores had stronger associations with scores on the Short-Form 36 Physical Function (r?=?0.79) than with scores on other legacy measures.The four PROMIS static-short forms performed well among individuals with symptomatic knee osteoarthritis as evidenced in correlations with legacy measures. PROMIS Anxiety and Depression target general mental health (e.g., stress, depression), and PROMIS Pain Interference and Physical Function static-short forms target whole-body outcomes among participants with symptomatic knee osteoarthritis. Floor effects in the PROMIS Anxiety and Depression scores should be considered if needing to distinguish among patients with very low levels of these outcomes.Clinicaltrials.gov NCT01258985. Registered 10 December 2010.

SUBMITTER: Driban JB

PROVIDER: S-EPMC4570513 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Patient-Reported Outcomes Measurement Information System (PROMIS) instruments among individuals with symptomatic knee osteoarthritis: a cross-sectional study of floor/ceiling effects and construct validity.

Driban Jeffrey B JB Morgan Nani N Price Lori Lyn LL Cook Karon F KF Wang Chenchen C

BMC musculoskeletal disorders 20150914

<h4>Background</h4>The psychometric properties of Patient Reported Outcomes Measurement Information System (PROMIS) instruments have been explored in a number of general and clinical samples. No study, however, has evaluated the psychometric function of these measures in individuals with symptomatic knee osteoarthritis (KOA). The aim of this project was to evaluate the construct (structural) validity and floor/ceiling effects of four PROMIS measures in this population.<h4>Methods</h4>We conducte ...[more]

PMID: 26369412

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Project description:BackgroundWe recently developed a model of stratified exercise therapy, consisting of (i) a stratification algorithm allocating patients with knee osteoarthritis (OA) into one of the three subgroups ('high muscle strength subgroup' representing a post-traumatic phenotype, 'low muscle strength subgroup' representing an age-induced phenotype, and 'obesity subgroup' representing a metabolic phenotype) and (ii) subgroup-specific exercise therapy. In the present study, we aimed to test the construct validity of this algorithm.MethodsData from five studies (four exercise therapy trial cohorts and one cross-sectional cohort) were used to test the construct validity of our algorithm by 63 a priori formulated hypotheses regarding three research questions: (i) are the proportions of patients in each subgroup similar across cohorts? (15 hypotheses); (ii) are the characteristics of each of the subgroups in line with their proposed underlying phenotypes? (30 hypotheses); (iii) are the effects of usual exercise therapy in the 3 subgroups in line with the proposed effect sizes? (18 hypotheses).ResultsBaseline data from a total of 1211 patients with knee OA were analyzed for the first and second research question, and follow-up data from 584 patients who were part of an exercise therapy arm within a trial for the third research question. In total, the vast majority (73%) of the hypotheses were confirmed. Regarding our first research question, we found similar proportions in each of the three subgroups across cohorts, especially for three cohorts. Regarding our second research question, subgroup characteristics were almost completely in line with the proposed underlying phenotypes. Regarding our third research question, usual exercise therapy resulted in similar, medium to large effect sizes for knee pain and physical function for all three subgroups.ConclusionWe found mixed results regarding the construct validity of our stratification algorithm. On the one hand, it is a valid instrument to consistently allocate patients into subgroups that aligned our hypotheses. On the other hand, in contrast to our hypotheses, subgroups did not differ substantially in effects of usual exercise therapy. An ongoing trial will assess whether this algorithm accompanied by subgroup-specific exercise therapy improves clinical and economic outcomes.

Project description:BACKGROUND:The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a commonly used knee assessment and outcome tool in both clinical work and research. However, it has not been formally translated and validated in Finnish. The purpose of this study was to translate and culturally adapt the KOOS questionnaire into Finnish and to determine its validity and reliability among Finnish middle-aged patients with knee injuries. METHODS:KOOS was translated and culturally adapted from English into Finnish. Subsequently, 59 patients with knee injuries completed the Finnish version of KOOS, Western Ontario and McMaster Osteoarthritis Index (WOMAC), Short-Form 36 Health Survey (SF-36) and Numeric Pain Rating Scale (Pain-NRS). The same KOOS questionnaire was re-administered 2 weeks later. Psychometric assessment of the Finnish KOOS was performed by testing its construct validity and reliability by using internal consistency, test-retest reliability and measurement error. The floor and ceiling effects were also examined. RESULTS:The cross-cultural adaptation revealed only minor cultural differences and was well received by the patients. For construct validity, high to moderate Spearman's Correlation Coefficients were found between the KOOS subscales and the WOMAC, SF-36, and Pain-NRS subscales. The Cronbach's alpha was from 0.79 to 0.96 for all subscales indicating acceptable internal consistency. The test-retest reliability was good to excellent, with Intraclass Correlation Coefficients ranging from 0.73 to 0.86 for all KOOS subscales. The minimal detectable change ranged from 17 to 34 on an individual level and from 2 to 4 on a group level. No floor or ceiling effects were observed. CONCLUSION:This study yielded an appropriately translated and culturally adapted Finnish version of KOOS which demonstrated good validity and reliability. Our data indicate that the Finnish version of KOOS is suitable for assessment of the knee status of Finnish patients with different knee complaints. Further studies are needed to evaluate the predictive ability of KOOS in the Finnish population.

Project description:BackgroundExperimental and clinical evidence support a link between body representations and pain. This proof-of-concept study in people with painful knee osteoarthritis (OA) aimed to determine if: (i) visuotactile illusions that manipulate perceived knee size are analgesic; (ii) cumulative analgesic effects occur with sustained or repeated illusions.MethodsParticipants with knee OA underwent eight conditions (order randomised): stretch and shrink visuotactile (congruent) illusions and corresponding visual, tactile and incongruent control conditions. Knee pain intensity (0-100 numerical rating scale; 0 = no pain at all and 100 = worst pain imaginable) was assessed pre- and post-condition. Condition (visuotactile illusion vs control) × Time (pre-/post-condition) repeated measure ANOVAs evaluated the effect on pain. In each participant, the most beneficial illusion was sustained for 3 min and was repeated 10 times (each during two sessions); paired t-tests compared pain at time 0 and 180s (sustained) and between illusion 1 and illusion 10 (repeated).ResultsVisuotactile illusions decreased pain by an average of 7.8 points (95% CI [2.0-13.5]) which corresponds to a 25% reduction in pain, but the tactile only and visual only control conditions did not (Condition × Time interaction: p = 0.028). Visuotactile illusions did not differ from incongruent control conditions where the same visual manipulation occurred, but did differ when only the same tactile input was applied. Sustained illusions prolonged analgesia, but did not increase it. Repeated illusions increased the analgesic effect with an average pain decrease of 20 points (95% CI [6.9-33.1])-corresponding to a 40% pain reduction.DiscussionVisuotactile illusions are analgesic in people with knee OA. Our results suggest that visual input plays a critical role in pain relief, but that analgesia requires multisensory input. That visual and tactile input is needed for analgesia, supports multisensory modulation processes as a possible explanatory mechanism. Further research exploring the neural underpinnings of these visuotactile illusions is needed. For potential clinical applications, future research using a greater dosage in larger samples is warranted.

Dataset Information

Patient-Reported Outcomes Measurement Information System (PROMIS) instruments among individuals with symptomatic knee osteoarthritis: a cross-sectional study of floor/ceiling effects and construct validity.

Publications

Patient-Reported Outcomes Measurement Information System (PROMIS) instruments among individuals with symptomatic knee osteoarthritis: a cross-sectional study of floor/ceiling effects and construct validity.

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