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Reliability and clinically important improvement thresholds for osteoarthritis pain and function scales: a multicenter study.

ABSTRACT: To assess the reliability and clinically meaningful thresholds of intermittent and constant osteoarthritis pain (ICOAP) score, the Knee injury and Osteoarthritis Outcome Score Physical function Short-form (KOOS-PS), the Hip disability and Osteoarthritis Outcome Score Physical function Short-form (HOOS-PS), and the Quality of life subscales of HOOS/KOOS (HOOS-QOL/KOOS-QOL) in patients with knee or hip arthritis.One hundred and ninety-five patients (141 knee, 54 hip) seen at 2 orthopedic outpatient clinics with a diagnosis of knee or hip OA completed patient-reported questionnaires (ICOAP pain scale, KOOS-PS, HOOS-PS, KOOS-QOL, HOOS-QOL) at baseline and 2-week followup. Reliability was assessed using intraclass correlation coefficients (ICC). We calculated minimum clinically important difference (MCID) and moderate improvement in the subgroup that reported change in the status of their affected joint.The reliability as assessed by ICC was as follows: ICOAP pain scale, 0.63 (0.48, 0.74) in patients with knee arthritis, and 0.86 (0.73, 0.93) for hip arthritis; KOOS-PS, 0.66 (0.52, 0.77); HOOS-PS, 0.82 (0.66, 0.91); KOOS-QOL, 0.79 (0.69, 0.86); and HOOS-QOL, 0.67 (0.42, 0.83). MCID and moderate improvement estimates in patients with knee arthritis were ICOAP pain scale, 18.5 and 26.7; KOOS-PS, 2.2 and 15.0; and KOOS-QOL, 8.0 and 15.6. A smaller sample in patients with hip arthritis precluded MCID and moderate improvement estimates.We found that ICOAP pain and KOOS-PS/HOOS-PS scales were reasonably reliable in patients with hip OA. Reliability of these scales was much lower in patients with knee arthritis. Thresholds for clinically meaningful change in pain or function on these scales were estimated for patients with knee arthritis.

SUBMITTER: Singh JA

PROVIDER: S-EPMC3943561 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

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Reliability and clinically important improvement thresholds for osteoarthritis pain and function scales: a multicenter study.

Singh Jasvinder A JA Luo Ruili R Landon Glenn C GC Suarez-Almazor Maria M

The Journal of rheumatology 20140115 3

<h4>Objective</h4>To assess the reliability and clinically meaningful thresholds of intermittent and constant osteoarthritis pain (ICOAP) score, the Knee injury and Osteoarthritis Outcome Score Physical function Short-form (KOOS-PS), the Hip disability and Osteoarthritis Outcome Score Physical function Short-form (HOOS-PS), and the Quality of life subscales of HOOS/KOOS (HOOS-QOL/KOOS-QOL) in patients with knee or hip arthritis.<h4>Methods</h4>One hundred and ninety-five patients (141 knee, 54 h ...[more]

PMID: 24429183

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Project description:BackgroundUnderstanding minimum clinically important differences (MCID) in patient-reported outcomes is essential in interpreting the magnitude of changes in these measures. No MCID from patients' perspectives has ever been published for peripheral artery disease-specific health status assessment tools. The Peripheral Artery Questionnaire (PAQ) is a commonly used, validated peripheral artery disease-specific health status instrument for which we sought to prospectively establish its MCID from patients' perspectives.Methods and resultsPatients presenting to vascular clinics with new or worsened claudication in the US cohort of the PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry who completed baseline and follow-up PAQ assessments along with the Global Assessment of Functioning scale were included. Mean change in PAQ summary scores from 3- to 6-month follow-up was calculated according to Global Assessment of Functioning category. MCID was defined as the mean difference in scores between those with small improvement or deterioration and those with no change. Multivariable linear regression was used to provide an MCID estimate after adjusting for patients' 3-month PAQ score. Of the 483 patients who completed the Global Assessment of Functioning score at 6 months and who had available 3- and 6-month PAQ assessments, the mean age was 69 years, 42% were female, and 71% were White. The MCIDs for PAQ summary scale improvement and worsening were 8.7 (2.9-14.5) and -11.0 (-18.6 to -3.3), respectively. After multivariable adjustment, these were 8.9 (3.0-14.8) and -11.2 (-18.2 to -4.2), respectively. There was no significant interaction between treatment (invasive versus noninvasive) and Global Assessment of Functioning response (P=0.75).ConclusionsIn patients with new or worsened claudication, a 10-point change in PAQ summary score represents an MCID. This estimate needs external validation and may inform the interpretation of PAQ scores when used as outcomes in clinical trials or in routine clinical care. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01419080.

Project description:The objective was to determine the minimum and ideal clinically significant differences (MCSD, ICSD) in pain intensity in children for the Faces Pain Scale-Revised (FPS-R) and the Color Analog Scale (CAS) and to identify any differences in these estimates based on patient characteristics.This was a prospective study of children aged 4 to 17 years with acute pain presenting to two urban pediatric emergency departments. Participants self-reported their pain intensity using the FPS-R and CAS and qualitatively described their changes in pain. Changes in pain score reported using the FPS-R and CAS that were associated with "a little less" and "much less" pain (MCSD and ICSD, respectively) were identified using a receiver operating characteristic-based method and expressed as raw change score and percent reductions. Estimates of MCSD and ICSD were determined for each category of initial pain intensity (mild, moderate, and severe) and patient characteristics (age, sex, and ethnicity). Post hoc exploratory analyses evaluated categories of race, primary language, and etiology of pain.A total of 314 children with acute pain were enrolled; mean (±SD) age was 9.8 (±3.8) years. The FPS-R raw change score and percent reduction MCSD estimates were 2/10 and 25%, with ICSD estimates of 3/10 and 60%. For the CAS, raw change score and percent reduction MCSD estimates were 1/10 and 15%, with ICSD estimates of 2.75/10 and 52%. For both scales, raw change score and percent reduction estimates of the MCSD remained unchanged in children with either moderate or severe pain. For both scales, estimates of ICSD were not stable across categories of initial pain intensity. There was no difference in MCSD or ICSD based on age, sex, ethnicity, race, primary language, or etiology of pain.The MCSD estimates can be expressed as raw change score and percent reductions for the FPS-R and CAS. These estimates appear stable for children with moderate to severe pain, irrespective of age, sex, and ethnicity. Estimates of ICSD were not stable across different categories of initial pain intensity, therefore limiting their potential generalizability.

Project description:BackgroundTo evaluate if early improvements in pain and function with subcutaneous tanezumab are meaningful and sustained over 24 weeks.MethodsPatients with moderate-to-severe osteoarthritis (hip or knee) in Europe and Japan were randomized to placebo, tanezumab 2.5 mg or tanezumab 5 mg (baseline, Week 8 and Week 16). Outcomes included: average daily index joint pain score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscales, rescue medication use, WOMAC responders (within-patient ≥30% reduction in WOMAC Pain or Physical Function), Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) responders (within-patient) and Patient-reported Treatment Impact Assessment-Modified questionnaire.ResultsPatients received placebo (n = 282), tanezumab 2.5 mg (n = 283) or tanezumab 5 mg (n = 284). Changes from baseline in average daily index joint pain (within the first week) and WOMAC subscales (Week 2 through Week 24) were greater for each tanezumab group versus placebo (least squares [LS] mean, unadjusted p ≤ .05). Rescue medication use (days/week) was lower for each tanezumab group versus placebo from Week 2 through Week 12 (LS mean, unadjusted p ≤ .05) but not at Week 16 or 24. A higher proportion of each tanezumab group than placebo achieved ≥30% reduction from baseline in WOMAC Pain or Physical Function, or OMERACT-OARSI response (Week 2 through Week 24, unadjusted p ≤ .05), or were satisfied with treatment at Week 24 (unadjusted p ≤ .05).ConclusionsSubcutaneous tanezumab, compared with placebo, reduced pain within the first week, and pain and function were improved throughout 24 weeks. The proportions of responders and patients satisfied were higher with tanezumab than placebo. ClinicalTrials.gov:NCT02709486.SignificanceThis exploratory analysis of data from a placebo-controlled, Phase 3 study of patients with moderate-to-severe osteoarthritis of the hip or knee for whom standard analgesics were not effective or could not be taken, found that onset of efficacy of subcutaneous tanezumab was within the first week, and efficacy was maintained through the 24-week treatment period. Tanezumab was effective in those patients with the most radiologically severe osteoarthritis.

Project description:BackgroundRapid advances in the past decade have shown that dysbiosis of the gut microbiome is a key hallmark of rheumatoid arthritis (RA). Yet, the relationship between the gut microbiome and clinical improvement in RA disease activity remains unclear. In this study, we explored the gut microbiome of patients with RA to identify features that are associated with, as well as predictive of, minimum clinically important improvement (MCII) in disease activity.MethodsWe conducted a retrospective, observational cohort study on patients diagnosed with RA between 1988 and 2014. Whole metagenome shotgun sequencing was performed on 64 stool samples, which were collected from 32 patients with RA at two separate time-points approximately 6-12 months apart. The Clinical Disease Activity Index (CDAI) of each patient was measured at both time-points to assess achievement of MCII; depending on this clinical status, patients were distinguished into two groups: MCII+ (who achieved MCII; n = 12) and MCII- (who did not achieve MCII; n = 20). Multiple linear regression models were used to identify microbial taxa and biochemical pathways associated with MCII while controlling for potentially confounding factors. Lastly, a deep-learning neural network was trained upon gut microbiome, clinical, and demographic data at baseline to classify patients according to MCII status, thereby enabling the prediction of whether a patient will achieve MCII at follow-up.ResultsWe found age to be the largest determinant of the overall compositional variance in the gut microbiome (R2 = 7.7%, P = 0.001, PERMANOVA). Interestingly, the next factor identified to explain the most variance in the gut microbiome was MCII status (R2 = 3.8%, P = 0.005). Additionally, by looking at patients' baseline gut microbiome profiles, we observed significantly different microbiome traits between patients who eventually showed MCII and those who did not. Taxonomic features include alpha- and beta-diversity measures, as well as several microbial taxa, such as Coprococcus, Bilophila sp. 4_1_30, and Eubacterium sp. 3_1_31. Notably, patients who achieved clinical improvement had higher alpha-diversity in their gut microbiomes at both baseline and follow-up visits. Functional profiling identified fifteen biochemical pathways, most of which were involved in the biosynthesis of L-arginine, L-methionine, and tetrahydrofolate, to be differentially abundant between the MCII patient groups. Moreover, MCII+ and MCII- groups showed significantly different fold-changes (from baseline to follow-up) in eight microbial taxa and in seven biochemical pathways. These results could suggest that, depending on the clinical course, gut microbiomes not only start at different ecological states, but also are on separate trajectories. Finally, the neural network proved to be highly effective in predicting which patients will achieve MCII (balanced accuracy = 90.0%, leave-one-out cross-validation), demonstrating potential clinical utility of gut microbiome profiles.ConclusionsOur findings confirm the presence of taxonomic and functional signatures of the gut microbiome associated with MCII in RA patients. Ultimately, modifying the gut microbiome to enhance clinical outcome may hold promise as a future treatment for RA.

Project description:OBJECTIVES:Chronic Obstructive Pulmonary Disease (COPD) is a progressive disease. Preventing deterioration of health status is therefore an important therapy goal. (Minimal) Clinically Important Differences ((M)CIDs) are used to interpret changes observed. It remains unclear whether (M)CIDs are similar for both deterioration and improvement in health status. This study investigates and compares these clinical thresholds for three widely-used questionnaires. DESIGN AND SETTING:Data were retrospectively analysed from an inhouse 3-week pulmonary rehabilitation (PR) randomised controlled trial in the German Klinik Bad Reichenhall (study 1), and observational research in Dutch primary and secondary routine clinical practice (RCP) (study 2). PARTICIPANTS:Patients with COPD aged ≥18 years (study 1) and aged ≥40 years (study 2) without respiratory comorbidities were included for analysis. PRIMARY OUTCOMES:The COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ) and St George's Respiratory Questionnaire (SGRQ) were completed at baseline and at 3, 6 and 12 months. A Global Rating of Change scale was added at follow-up. Anchor-based and distribution-based methods were used to determine clinically relevant thresholds. RESULTS:In total, 451 patients were included from PR and 207 from RCP. MCIDs for deterioration ranged from 1.30 to 4.21 (CAT), from 0.19 to 0.66 (CCQ), and from 2.75 to 7.53 (SGRQ). MCIDs for improvement ranged from -3.78 to -1.53 (CAT), from -0.50 to -0.19 (CCQ), and from -9.20 to -2.76 (SGRQ). Thresholds for moderate improvement versus deterioration ranged from -5.02 to -3.29 vs 3.89 to 8.14 (CAT), from -0.90 to -0.72 vs 0.42 to 1.23 (CCQ), and from -15.85 to -13.63 vs 7.46 to 9.30 (SGRQ). CONCLUSIONS:MCID ranges for improvement and deterioration on the CAT, CCQ and SGRQ were somewhat similar. However, estimates for moderate and large change varied and were inconsistent. Thresholds differed between study settings. TRIAL REGISTRATION NUMBER:Routine Inspiratory Muscle Training within COPD Rehabilitation trial: #DRKS00004609; MCID study: #UMCG201500447.

Dataset Information

Reliability and clinically important improvement thresholds for osteoarthritis pain and function scales: a multicenter study.

Publications

Reliability and clinically important improvement thresholds for osteoarthritis pain and function scales: a multicenter study.

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