RAPID3 (Routine Assessment of Patient Index Data 3) severity categories and response criteria: Similar results to DAS28 (Disease Activity Score) and CDAI (Clinical Disease Activity Index) in the RAPID 1 (Rheumatoid Arthritis Prevention of Structural Damage) clinical trial of certolizumab pegol

Pincus, Theodore; Furer, Victoria; Keystone, Edward; Yazıcı, Yusuf; Bergman, Martin; Luijtens, K.

doi:10.1002/acr.20481

Cited by 73 publications

(58 citation statements)

References 13 publications

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“…In addition, the results of this study suggest that clinicians should consider evaluating PROs in patients who report disease activity despite objective improvements, or introducing PRO‐based assessments, such as the Routine Assessment of Patient Index Data 3, which includes patient‐reported physical function, pain, and global assessment 30 into routine clinical practice. Particular attention should be paid to self‐reported pain, as pain appears to play a key role in patient perceptions of overall well‐being.…”

Section: Discussionmentioning

confidence: 99%

Association of Improvement in Pain With Therapeutic Response as Determined by Individual Improvement Criteria in Patients With Rheumatoid Arthritis

Scharbatke

Behrens

Schmalzing

et al. 2016

Arthritis Care & Research

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ObjectiveTo use statistical methods to establish a threshold for individual response in patient‐reported outcomes (PROs) in patients with rheumatoid arthritis.MethodsWe used an analysis of variance model in patients on stable therapy (discovery cohort) to establish critical differences (dcrit) for the minimum change associated with a significant individual patient response (beyond normal variation) in the PRO measures of pain (0–10), fatigue (0–10), and function (Funktionsfragebogen Hannover questionnaire; 0–100). We then evaluated PRO responses in patients initiating adalimumab in a noninterventional study (treatment cohort).ResultsIn the discovery cohort (n = 700), PROs showed excellent long‐term retest reliability. The minimum change that exceeded random fluctuation was conservatively determined to be 3 points for pain, 4 points for fatigue, and 16 points for function. In the treatment cohort (n = 2,788), 1,483 patients (53.2%) achieved a significant individual therapeutic response as assessed by Disease Activity Score in 28 joints (DAS28)–dcrit (≥1.8 points) after 12 months of adalimumab treatment; 68.5% of patients with a DAS28‐dcrit response achieved a significant improvement in pain, whereas approximately 40% achieved significant improvements in fatigue or function. Significant improvements in all 3 PROs occurred in 22.7% of patients; 22.8% did not have any significant PRO responses. In contrast, significant improvements in all 3 PROs occurred in only 4.4% of 1,305 patients who did not achieve a DAS28‐dcrit response at month 12, and 59.1% did not achieve any significant PRO responses.ConclusionThe establishment of critical differences in PROs distinguishes true responses from random variation and provides insights into appropriate patient management.

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Section: Discussionmentioning

confidence: 99%

Association of Improvement in Pain With Therapeutic Response as Determined by Individual Improvement Criteria in Patients With Rheumatoid Arthritis

Scharbatke

Behrens

Schmalzing

et al. 2016

Arthritis Care & Research

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“…65 Within the pilot trial the mean baseline RAPID3 score was just over 12 units (50% classified as high severity), with a SD of ≈ 5 units. At 7 months, the SDs were ≈ 6 units and 6.8 units for the advice and physiotherapy group and within the advice-only group, respectively.…”

Section: Stage 3: Physiotherapy For Hypermobility Trial -Quantitativementioning

confidence: 99%

“…Response criteria for the RAPID3 score have been proposed as a decrease in score of 3.6 units or more for a 'good' response, and 1.8 units or more for a 'moderate' response. 65 In terms of high, moderate and low severity, …”

Section: Routine Assessment Of Patient Index Data 3 Scorementioning

confidence: 99%

“…The function, pain and global rating scores can be summed to provide a Routine Assessment of Patient Index Data 3 (RAPID3) score (scored 0-30), which has been shown to compare favourably with other scores such as the Disease Activity Score and Clinical Disease Activity Index. 65 The self-reported joint count item is also known as the Rheumatoid Arthritis Disease Activity Index (RADAI). Higher scores on all MDHAQ items represent increasing condition severity.…”

Section: Quantitative Aspectsmentioning

confidence: 99%

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The feasibility of a randomised controlled trial of physiotherapy for adults with joint hypermobility syndrome

Palmer

Cramp

Clark

et al. 2016

Health Technol Assess

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BackgroundJoint hypermobility syndrome (JHS) is a heritable disorder associated with laxity and pain in multiple joints. Physiotherapy is the mainstay of treatment, but there is little research investigating its clinical effectiveness.ObjectivesTo develop a comprehensive physiotherapy intervention for adults with JHS; to pilot the intervention; and to conduct a pilot randomised controlled trial (RCT) to determine the feasibility of conducting a future definitive RCT.DesignPatients’ and health professionals’ perspectives on physiotherapy for JHS were explored in focus groups (stage 1). A working group of patient research partners, clinicians and researchers used this information to develop the physiotherapy intervention. This was piloted and refined on the basis of patients’ and physiotherapists’ feedback (stage 2). A parallel two-arm pilot RCT compared ‘advice’ with ‘advice and physiotherapy’ (stage 3). Random allocation was via an automated randomisation service, devised specifically for the study. Owing to the nature of the interventions, it was not possible to blind clinicians or patients to treatment allocation.SettingStage 1 – focus groups were conducted in four UK locations. Stages 2 and 3 – piloting of the intervention and the pilot RCT were conducted in two UK secondary care NHS trusts.ParticipantsStage 1 – patient focus group participants (n = 25, three men) were aged > 18 years, had a JHS diagnosis and had received physiotherapy within the preceding 12 months. The health professional focus group participants (n = 16, three men; 14 physiotherapists, two podiatrists) had experience of managing JHS. Stage 2 – patient participants (n = 8) were aged > 18 years, had a JHS diagnosis and no other musculoskeletal conditions causing pain. Stage 3 – patient participants for the pilot RCT (n = 29) were as for stage 2 but the lower age limit was 16 years.InterventionFor the pilot RCT (stage 3) the advice intervention was a one-off session, supplemented by advice booklets. All participants could ask questions specific to their circumstances and receive tailored advice. Participants were randomly allocated to ‘advice’ (no further advice or physiotherapy) or ‘advice and physiotherapy’ (an additional six 30-minute sessions over 4 months). The physiotherapy intervention was supported by a patient handbook and was delivered on a one-to-one patient–therapist basis. It aimed to increase patients’ physical activity through developing knowledge, understanding and skills to better manage their condition.Main outcome measuresData from patient and health professional focus groups formed the main outcome from stage 1. Patient and physiotherapist interview data also formed a major component of stages 2 and 3. The primary outcome in stage 3 related to the feasibility of a future definitive RCT [number of referrals, recruitment and retention rates, and an estimate of the value of information (VOI) of a future RCT]. Secondary outcomes included clinical measures (physical function, pain, global status, self-reported joint count, quality of life, exercise self-efficacy and adverse events) and resource use (to estimate cost-effectiveness). Outcomes were recorded at baseline, 4 months and 7 months.ResultsStage 1 – JHS is complex and unpredictable. Physiotherapists should take a long-term holistic approach rather than treating acutely painful joints in isolation. Stage 2 – a user-informed physiotherapy intervention was developed and evaluated positively. Stage 3 – recruitment to the pilot RCT was challenging, primarily because of a perceived lack of equipoise between advice and physiotherapy. The qualitative evaluation provided very clear guidance to inform a future RCT, including enhancement of the advice intervention. Some patients reported that the advice intervention was useful and the physiotherapy intervention was again evaluated very positively. The rate of return of questionnaires was low in the advice group but reasonable in the physiotherapy group. The physiotherapy intervention showed evidence of promise in terms of primary and secondary clinical outcomes. The advice arm experienced more adverse events. The VOI analysis indicated the potential for high value from a future RCT. Such a trial should form the basis of future research efforts.ConclusionA future definitive RCT of physiotherapy for JHS seems feasible, although the advice intervention should be made more robust to address perceived equipoise and subsequent attrition.Trial registrationCurrent Controlled Trials ISRCTN29874209.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 47. See the NIHR Journals Library website for further project information.

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“…Usually, the "artisan" approach is criticized for the following reasons: 1. The tool to evaluate the level of disease activity is not uniformly recognized (e.g., the DAS28-ESR 1 , the RAPID-3 14 , no swollen joints at ultrasonography 15 ). For example, in the study reported in this issue of The Journal 1 , the authors have noticed that the increase in treatments was not only based on the number of swollen joints but also the size of the joints affected by synovitis (larger joint involvement was more likely to influence treatment than number of swollen joints).…”

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confidence: 99%

A Rheumatologist Managing Patients with Rheumatoid Arthritis: An Artisan But Also An Artist!

Dougados

2012

J Rheumatol

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RAPID3 (Routine Assessment of Patient Index Data 3) severity categories and response criteria: Similar results to DAS28 (Disease Activity Score) and CDAI (Clinical Disease Activity Index) in the RAPID 1 (Rheumatoid Arthritis Prevention of Structural Damage) clinical trial of certolizumab pegol

Cited by 73 publications

References 13 publications

Association of Improvement in Pain With Therapeutic Response as Determined by Individual Improvement Criteria in Patients With Rheumatoid Arthritis

Association of Improvement in Pain With Therapeutic Response as Determined by Individual Improvement Criteria in Patients With Rheumatoid Arthritis

The feasibility of a randomised controlled trial of physiotherapy for adults with joint hypermobility syndrome

A Rheumatologist Managing Patients with Rheumatoid Arthritis: An Artisan But Also An Artist!

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