Correlation of patient-reported routine assessment of patient index data with clinical measures of disease activity in psoriatic arthritis.
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ABSTRACT: Aim
A treat-to-target strategy is recommended for management of psoriatic arthritis (PsA), although there is lack of agreement regarding the best measure of disease activity to target. Physician assessments included in traditional indices can be complex and time consuming to complete and cannot be readily conducted by telehealth. This study compares the routine assessment of patient index data 3 (RAPID3), an efficient tool comprising patient self-assessment, with traditional clinician-led composite measures in the PsA clinic setting.Methods
Data were collected prospectively from July 2016 to March 2020 in 2 dedicated PsA clinics in Sydney, Australia. A receiver operating characteristic (ROC) curve was created for comparison of RAPID3 score with composite scores minimal disease activity (MDA), very low disease activity (VLDA) and disease activity in psoriatic arthritis (DAPSA) in low disease activity or remission.Results
Ninety-three patients had simultaneous collection of RAPID3 and MDA measures. Mean (SD) age was 49.9 (13.5) years, 50.5% were male and 23 (24.7%) had erosive disease at baseline. RAPID3 scores ≤3.2 and ≤2.7 (range 0-30) had high sensitivity and specificity for VLDA and DAPSA remission respectively, with ROC curve area under the curve (95% CI) of 0.94 (0.91-0.97) and 0.96 (0.93-0.99).Conclusion
RAPID3 has good agreement with physician-led composite scores of MDA, VLDA and DAPSA, and provides a viable alternative to composite scores. This is particularly helpful in settings that do not allow for clinical examination, for example telehealth.
SUBMITTER: Ward L
PROVIDER: S-EPMC9310573 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveWe evaluated the psychometric properties of 3 patient-reported outcome measures to assess the physical function in psoriatic arthritis (PsA).MethodsData were available for the Health Assessment Questionnaire disability index (HAQ DI), the 12-item Short Form instrument physical component summary (SF-12 PCS), and the Psoriatic Arthritis Impact of Disease instrument functional capacity score (PsAID-FC). Data came from a longitudinal study in 14 countries of consecutive adults with definite PsA with ≥2 years of duration. The score distribution, construct validity, responsiveness, and thresholds of meaning of the patient-reported outcome measures were evaluated.ResultsAt baseline, 414 subjects (52% male) were analyzed. The mean ± SD age was 52.4 ± 12.5 years and duration of illness was 10.9 ± 8.1 years. Ceiling effects were noted in 31% and 21% of patients for HAQ DI and PsAID-FC, respectively; floor effects were minimal. All 3 patient-reported outcome measures met a priori hypotheses for construct validity. After a median follow-up of 4.1 (interquartile range 2.7) months in 350 patients, 27%, 54%, and 18% of patients reported themselves improved, not changed, and worsened, respectively. Change scores were statistically different for groups for worsening versus no-change for all patient-reported outcome measures. PsAID-FC was more sensitive to change than the other 2 patient-reported outcome measures. Comparing groups with worsening condition to no-change, the standardized response mean square ratios were HAQ DI 29.9, SF-12 PCS 16.7, and PsAID-FC 40.1.ConclusionHAQ DI, SF-12 PCS, and PsAID-FC are valid measures of physical function for PsA. PsAID-FC, a single question, performed similarly to the other patient-reported outcome measures and may be an additional option to measure PsA-specific physical function.
| S-EPMC7371516 | biostudies-literature
Project description:BackgroundIn psoriatic arthritis (PsA), further understanding of the relationships between clinical measures and patient-reported outcomes (PROs) is needed. This post hoc analysis evaluated associations between minimal disease activity (MDA) as a continuous outcome (termed ScoreMDA) or Psoriatic Arthritis Disease Activity Score (PASDAS) with selected PROs not included in the composite measures.MethodsData from two phase 3 studies of tofacitinib in PsA (OPAL Broaden [NCT01877668; N = 422]; OPAL Beyond [NCT01882439; N = 394]) were included. MDA (binary outcome) was defined as meeting ≥5/7 criteria. For ScoreMDA, each criterion was assigned a value (1 = true; 0 = false; score range, 0-7; scores ≥5 indicated MDA). For PASDAS (score range, 0-10), higher scores indicated worse disease activity. PROs analyzed included Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Patient's Assessment of Arthritis Pain visual analog scale (Pain VAS), and EuroQoL-Five Dimensions-Three Level Health Questionnaire visual analog scale (EQ-5D-3L VAS) and utility index. Relationships were evaluated using repeated measures regression models.ResultsSimilar, approximately linear relationships were confirmed between PASDAS or ScoreMDA and PROs in both studies. In OPAL Broaden and OPAL Beyond, a one-point difference in PASDAS was associated with clinically relevant differences in PROs, including EQ-5D-3L VAS (- 6.7 mm, - 6.9 mm), Pain VAS (9.9 mm, 10.7 mm), and FACIT-F (- 2.8, - 3.3). A one-point difference in ScoreMDA was associated with clinically relevant differences in PROs, including EQ-5D-3L VAS (5.0 mm, 5.5 mm) and FACIT-F (1.9, 2.7) in OPAL Broaden and OPAL Beyond, respectively.ConclusionsLinear associations between PASDAS or ScoreMDA and PROs provide interpretable and quantifiable metrics between composite clinical measures and PROs, highlighting the importance of these measures in understanding the relevance of treat-to-target goals in PsA.Trial registrationClinicalTrials.gov, NCT01877668 . Registered on June 12, 2013. ClinicalTrials.gov, NCT01882439 . Registered on June 18, 2013.
| S-EPMC7995583 | biostudies-literature
Project description:PurposeThe purpose of this study was to determine if the Single-Assessment Numeric Evaluation (SANE) score correlates with existing validated hip-specific patient-reported outcome measures (PROMs), including the Modified Harris Hip Score (mHHS), the International Hip Outcome Tool (IHOT-33), the Hip Outcome Score, Activities of Daily Living subscale (HOS-ADL), and the Hip Outcome Score, Sport-Specific subscale (HOS-SS), for patients preparing to undergo hip arthroscopy for treatment of femoroacetabular impingement syndrome (FAIS).MethodsA single surgeon's operative database was retrospectively reviewed to identify patients undergoing primary hip arthroscopy for treatment of FAIS from April 2018 to October 2019. Patient-specific factors including age, sex, body mass index (BMI), and duration of symptoms were collected. Preoperative SANE, mHHS, IHOT-33, HOS-ADL, and HOS-SS scores were analyzed. Statistical analysis using Pearson correlation was performed to identify the relationship between the SANE score and the mHHS, IHOT-33, HOS-ADL, and HOS-SS, preoperatively.Results154 patients were included in the study. The mean mHHS was 54.4 ± 11.7; mean IHOT-33 score was 32.7 ± 15.0; mean HOS-SS 42.9 ± 23.7; and mean HOS-ADL was 63.3 ± 1. The mean SANE score was 36.7 ± 19.9. The Simple Hip Score was directly correlated with the mHHS (P < .01), the IHOT-33 (P < .01); the HOS-ADL (P < .01), and the HOS-SS (P < .01). The mean patient age was 35.9 years; 109 (70.8%) were female and 45 (29.2%) were male. Average patient BMI was 26.9. At the time of patient completion of the questionnaire, the majority of patients (65%) had been having symptoms for >1 year.ConclusionThe SANE score was strongly correlated with mHHS, IHOT-33, HOS-ADL, and HOS-SS in the preoperative setting for patients undergoing hip arthroscopy for treatment of FAIS. Given its simplicity, SANE may be a valuable tool for rapid assessment of joint function and pain in this patient population.Level of evidenceIV, therapeutic case series.
| S-EPMC8129469 | biostudies-literature
Project description:Introduction: Integration of patient-reported outcome measures (PROMs) in routine clinical care is growing but lacks consolidated evidence around its impact on pediatric care. This systematic review aims to evaluate the impact of integrating PROMs in routine pediatric clinical care on various outcomes in pediatric clinical care. Data Sources: MEDLINE, Embase, CINAHL, PsycINFO, and Cochrane Library. Web of Science database was searched selectively to ensure extended coverage. Study Selection: We included longitudinal studies reporting on the integration of PROMs in routine pediatric clinical care of chronic diseases. Studies in languages other than English, published prior to the year 2000, and reporting on secondary data were excluded. Data Extraction: Two reviewers independently extracted data from included studies. Extracted data included citation of each study, type of healthcare setting, location of the study, characteristics of patient population, type of chronic disease, name and type of PROM, mode of administration, and reported outcomes. Results: Out of 6,869 articles, titles and abstracts of 5,416 articles and full text of 23 articles were screened in duplicate. Seven articles reporting results from six studies met eligibility criteria. Integration of PROMs increased the identification and discussion around health-related quality of life (HRQOL), especially in psychosocial and emotional domains, but showed mixed results with the impact on quality of care. No studies assessed the impact of integrating PROMs on healthcare utilization. Limitations: Due to significant heterogeneity in the studies, a meta-analysis was not conducted. Conclusions: Integrating PROMs could have a positive impact on HRQOL; however, further studies are required to determine the impact of PROMs in routine pediatric clinical care.
| S-EPMC7399166 | biostudies-literature
Project description:The effect of certolizumab pegol (CZP) on patient-reported outcomes (PROs) was investigated in 1063 patients with rheumatoid arthritis (RA) from the REALISTIC trial (double-blind, placebo-controlled to week 12, open-label to week 28; randomized 4:1 [CZP:placebo]). Correlations between PROs and RA signs and symptoms, and the relative efficacy of these measures, were examined.Adults with RA and an inadequate response to at least one disease-modifying antirheumatic drug were enrolled. PROs assessed included physical function (using the Health Assessment Questionnaire-Disability Index), pain, fatigue, sleep disturbance, Patient Global Assessment of Disease Activity (PtGA), Routine Assessment of Patient Index Data 3 (RAPID3), and Rheumatoid Arthritis Disease Activity Index (RADAI).Early significant and clinically meaningful improvements in all PROs were observed to week 12 with CZP vs. placebo and were maintained to the end of the trial (week 28). At week 12, up to one-third more CZP patients showed improvements compared with placebo that were greater than or equal to the minimal clinically important difference (MCID) in fatigue, sleep problems, pain, PtGA, RADAI, and RAPID3. The changes in PROs were correlated with clinical measures of disease activity, including the Disease Activity Score in 28 joints using C-reactive protein as well as tender and swollen joint counts.Rapid improvements in PROs were seen in patients with RA treated with CZP. The magnitude of improvement exceeded the MCID in multiple domains and demonstrated that CZP improves aspects of health-related quality of life that are meaningful to patients and superior to placebo. PROs provide information complementary to clinical outcomes in assessment of treatment benefits.ClinicalTrials.gov identifier: NCT00717236 . Registered on 15 July 2008.
| S-EPMC4662806 | biostudies-literature
Project description:IntroductionEnthesitis is a core outcome domain assessed in psoriatic arthritis (PsA) clinical trials. Limited evidence describes the impact of enthesitis on patient-reported outcomes (PROs) and physician satisfaction with current treatment options. The objective of this analysis is to characterize the impact of enthesitis on PROs and physician satisfaction with currently available treatment in clinical practice settings.MethodsCross-sectional survey of rheumatologists, dermatologists, and their consulting patients with PsA in Australia, Canada, European Union (EU5), and the USA conducted in 2018. Physicians assessed current presence and severity of enthesitis, overall disease severity, other symptoms experienced, and their satisfaction with the current treatment. PsA participant self-reported data included current pain level, EQ5D, Psoriatic Arthritis Impact of Disease (PsAID12), Health Assessment Questionnaire Disability Index (HAQ-DI), and Work Productivity and Activity Impairment Index (WPAI-SHP). Bivariate descriptive analyses were conducted to describe features and outcomes in participants with and without enthesitis.ResultsRheumatologists (454) and dermatologists (238) provided information for 3157 participants with PsA. Mean participant age was 49.2 years, and 45.9% were female. Enthesitis was present currently in 6.5% (205) of participants with PsA. Those with enthesitis had worse overall disease severity compared to those without enthesitis (12.2% vs 2.2% severe) and had more extraarticular manifestations, including nail psoriasis, dactylitis, and sacroiliitis. Enthesitis was associated with more pain, worse quality of life (QoL), increased disability, and a negative impact on work. Participants with enthesitis had higher NSAIDs and opioid pain medication use but similar biologic use. Physicians were significantly less satisfied with current PsA treatment in participants with enthesitis versus without enthesitis.ConclusionsParticipants with psoriatic arthritis with enthesitis experienced significantly higher disease burden than those without enthesitis but were not more likely to receive advanced therapies. Physicians were significantly more dissatisfied with treatment in patients with enthesitis than in those without it.
| S-EPMC7695789 | biostudies-literature
Project description:IntroductionPsoriatic arthritis (PsA) is underdiagnosed and has a substantial impact on quality of life, disability, and work productivity. The population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) survey examined the impact of PsA on patients' activities of daily living and unmet treatment needs.MethodsThis large-scale, random digit dialing, telephone survey of patients self-reporting a diagnosis of psoriasis and/or PsA was conducted in North America and Europe.ResultsIn all, 3426 patients participated in the survey, including 712 (21%) who identified themselves as having PsA. Over half of the patients reported severe PsA involving more than four joints. Eighty-three percent of patients with PsA visited a health-care provider within the past 12 months. Approximately one-quarter saw their primary care provider or dermatologist most often for their disease; 37% responded that their rheumatologist was the health-care provider seen most often for PsA. Patients with PsA reported a substantial impact of disease on physical function. One-third of patients with PsA reported missing work because of their disease and PsA impacted their ability to work full time. Over half of the patients with PsA (58%) reported receiving no treatment or topical therapy only, leaving their joint disease untreated. Factors associated with lack of adherence were perceived lack of efficacy and concerns about long-term safety.ConclusionsThe MAPP survey confirms that PsA has a significant impact on physical function and activities of daily living. Undertreatment of PsA suggests a need for improved screening and diagnosis as well as education about treatment options and adherence.FundingCelgene Corporation.
| S-EPMC4999579 | biostudies-literature
Project description:Study objectivesNarcolepsy, a chronic disorder of the central nervous system, is clinically characterized by a symptom pentad that includes excessive daytime sleepiness, cataplexy, sleep paralysis, hypnopompic/hypnagogic hallucinations, and disrupted nighttime sleep. Ideally, screening and diagnosis instruments that assist physicians in evaluating a patient for type 1 or type 2 narcolepsy would be brief, easy for patients to understand and physicians to score, and would identify or rule out the need for electrophysiological testing.MethodsA search of the literature was conducted to review patient-reported measures used for the assessment of narcolepsy, mainly in clinical trials, with the goal of summarizing existing scales and identifying areas that may require additional screening questions and clinical practice scales.ResultsOf the seven scales reviewed, the Epworth Sleepiness Scale continues to be an important outcome measure to screen adults for excessive daytime sleepiness, which may be associated with narcolepsy. Several narcolepsy-specific scales have demonstrated utility, such as the Ullanlinna Narcolepsy Scale, Swiss Narcolepsy Scale, and Narcolepsy Symptom Assessment Questionnaire, but further validation is required.ConclusionsAlthough the narcolepsy-specific scales currently in use may identify type 1 narcolepsy, there are no validated questionnaires to identify type 2 narcolepsy. Thus, there remains a need for short, easily understood, and well-validated instruments that can be readily used in clinical practice to distinguish narcolepsy subtypes, as well as other hypersomnias, and for assessing symptoms of these conditions during treatment.
| S-EPMC5406952 | biostudies-literature
Project description:IntroductionA systematic literature review was conducted with the aim to analyse the impact of comorbidity on patient-reported outcomes (PROs) in patients with psoriatic arthritis (PsA).MethodsA sensitive search strategy of the Medline, Embase and the Cochrane Library (up to March 2019) was applied to retrieve studies for inclusion in this systematic literature review. Abstracts of the ACR and EULAR scientific meetings were also searched. The selection criteria were: (1) patients with PsA (population) with a comorbidity (intervention) and (2) report of any impact of the comorbidity on PROs. Systematic literature reviews, randomized controlled trials and observational were included in this systematic literature review. Two of the authors selected the articles and collected the data.ResultsEighteen articles were included in this systematic literature review, with most being cross-sectional studies that included more than 9000 patients with PsA. Some studies analysed the impact of an individual comorbidity, such as fibromyalgia (FM), and in others the analysis was according to the number of comorbidities. The most frequently analysed PROs were function, quality of life and fatigue. Analysis of the studies included in the review showed that patients with a higher number of comorbidities and/or more severe comorbidities reported worse impacts of their disease on function, patient's global assessment (PGA), pain, fatigue, work disability and quality of life. Specifically, FM had a negative impact on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), function, quality of sleep and quality of life; anxiety and depression had a negative impact on function and fatigue; metabolic syndrome had a negative impact on BASDAI, function, PGA and quality of life; obesity had a negative impact on function and pain; smoking (current and ex-smokers) had a negative impact on pain, function, fatigue, quality of life and overall health; alcohol intake had a negative impact on pain, function, fatigue, quality of life and overall health.ConclusionsThe prevalence and impact of medical comorbidity on PROs are very high in patients with PsA.
| S-EPMC7211228 | biostudies-literature
Project description:We examined patient-reported outcomes (PROs) in The Study of Etanercept And Methotrexate in Patients with Psoriatic Arthritis (PsA); a 48-week, phase 3, randomised controlled trial that compared outcomes with methotrexate (MTX) monotherapy, etanercept monotherapy, and MTX+ etanercept in patients with PsA. Efficacy endpoints included: mean changes from baseline and proportion of patients who reported improvements≥minimal clinically important difference (MCID) at week 24 in treatment groups for Health Assessment Questionnaire-Disability Index, Patient Global Assessment (PtGA), Patient Global Assessment of Joint Pain (PtGAJP) and Medical Outcomes Study Short Form-36 Questionnaire (SF-36) Physical Component Summary (PCS), and Mental Component Summary, and eight domain scores. PROs were analysed as reported (observed), without multiplicity adjustment; therefore, p values are descriptive. At week 24, patients receiving etanercept monotherapy or MTX+ etanercept combination reported greater improvements (p≤0.05) in PtGA, PtGAJP and SF-36 PCS scores compared with those receiving MTX monotherapy. Compared with MTX monotherapy, higher proportions of patients receiving etanercept monotherapy and combination therapy reported improvements≥MCID in PtGA (etanercept vs MTX, p=0.005) and PtGAJP (MTX +etanercept vs MTX, p=0.038). Across PROs, proportions of patients reporting scores≥age and gender-matched normative values at week 24 ranged from 20.8% to 51.0% with MTX monotherapy, 30.9% to 48.8% with etanercept monotherapy, and 30.6% to 52.3% with MTX+ etanercept combination. Patients receiving etanercept monotherapy or MTX+ etanercept reported greater improvements from baseline in several PROs compared with those receiving MTX monotherapy. PROs should be incorporated in discussions between patients and clinicians regarding their treatment choices as they can help determine which treatments are more beneficial in patients with PsA.
| S-EPMC7813325 | biostudies-literature