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Special Article: 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis.
OBJECTIVE: To develop an evidence-based guideline for the pharmacologic and nonpharmacologic treatment of psoriatic arthritis (PsA), as a collaboration between the American College of Rheumatology (ACR) and the National Psoriasis Foundation (NPF). METHODS: We identified critical outcomes in PsA and clinically relevant PICO (population/intervention/comparator/outcomes) questions. A Literature Review Team performed a systematic literature review to summarize evidence supporting the benefits and harms of available pharmacologic and nonpharmacologic therapies for PsA. GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology was used to rate the quality of the evidence. A voting panel, including rheumatologists, dermatologists, other health professionals, and patients, achieved consensus on the direction and the strength of the recommendations. RESULTS: The guideline covers the management of active PsA in patients who are treatment-naive and those who continue to have active PsA despite treatment, and addresses the use of oral small molecules, tumor necrosis factor inhibitors, interleukin-12/23 inhibitors (IL-12/23i), IL-17 inhibitors, CTLA4-Ig (abatacept), and a JAK inhibitor (tofacitinib). We also developed recommendations for psoriatic spondylitis, predominant enthesitis, and treatment in the presence of concomitant inflammatory bowel disease, diabetes, or serious infections. We formulated recommendations for a treat-to-target strategy, vaccinations, and nonpharmacologic therapies. Six percent of the recommendations were strong and 94% conditional, indicating the importance of active discussion between the health care provider and the patient to choose the optimal treatment. CONCLUSION: The 2018 ACR/NPF PsA guideline serves as a tool for health care providers and patients in the selection of appropriate therapy in common clinical scenarios. Best treatment decisions consider each individual patient situation. The guideline is not meant to be proscriptive and should not be used to limit treatment options for patients with PsA.
Endorsement of the 66/68 Joint Count for the Measurement of Musculoskeletal Disease Activity: OMERACT 2018 Psoriatic Arthritis Workshop Report.
OBJECTIVE: The Psoriatic Arthritis (PsA) Core Domain Set for randomized controlled trials and longitudinal observational studies has recently been updated. The joint counts are central to the measurement of the peripheral arthritis component of the musculoskeletal (MSK) disease activity domain. We report the Outcome Measures in Rheumatology (OMERACT) 2018 meeting's approaches to seek endorsement of the 66/68 swollen and tender joint count (SJC66/TJC68) for inclusion in the PsA Core Outcome Measurement Set (COS). METHODS: Using the OMERACT Filter 2.1 Instrument Selection Process, the SJC66/TJC68 was assessed for (1) domain match, (2) feasibility, (3) numerical sense (construct validity), and (4) discrimination (test retest reliability, longitudinal construct validity, sensitivity in clinical trials, and thresholds of meaning). A protocol was designed to assess the measurement properties of the SJC66/TJC68 joint count. The results were summarized in a Summary of Measurement Properties table developed by OMERACT. OMERACT members discussed and voted on whether the strength of the evidence supported that the SJC66/TJC68 had passed the OMERACT Filter as an outcome measurement instrument for the PsA COS. RESULTS: OMERACT delegates endorsed the use of the SJC66/TJC68 for the measurement of the peripheral arthritis component of the MSK disease activity domain. Among patient research partners, 100% voted for a "green" endorsement, whereas among the group of other stakeholders, 88% voted for a "green" endorsement. CONCLUSION: The SJC66/TJC68 is the first fully endorsed outcome measurement instrument using the OMERACT Filter 2.1 and the first instrument fully endorsed within the PsA COS.
PsAID12 Provisionally Endorsed at OMERACT 2018 as Core Outcome Measure to Assess Psoriatic Arthritis-specific Health-related Quality of Life in Clinical Trials.
OBJECTIVE: The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and Outcome Measures in Rheumatology (OMERACT) psoriatic arthritis (PsA) working group is developing a Core Outcome Measurement Set for PsA clinical trials [randomized controlled trials (RCT) and longitudinal observational studies (LOS)] using the OMERACT Filter 2.1 instrument selection algorithm. Our objective was to assess the Psoriatic Arthritis Impact of Disease questionnaire (PsAID12) for the measurement of the core domain PsA-specific health-related quality of life (HRQOL). METHODS: PsAID12 measurement property evidence gathered in a systematic literature review, and additional analyses conducted in LOS, were used to inform a consensus process. Analyses that had not been published were independently reviewed by the OMERACT technical advisory group. Data and process were presented, discussed in breakout groups, and voted on at the OMERACT conference (Terrigal, Australia, May 2018). RESULTS: PsAID12 fulfilled the green (good to go) OMERACT standards for domain match, feasibility, reliability, and construct/longitudinal construct validity. Discrimination and thresholds of meaning were amber (caution but good enough to go forward). The overall working group recommendation was amber/provisional endorsement of PsAID12 for measuring PsA-specific HRQOL in RCT and LOS. Of 96 participants who voted at the PsA OMERACT workshop, 87.5% (84) voted "yes" to endorse this recommendation; 14 of the 96 were patient research partners (PRP) and 93% of them (13) voted "yes"; 82 participants were not PRP and 87% of them (71) voted "yes." CONCLUSION: At OMERACT 2018, PsAID12 was the first patient-reported outcome measure provisionally endorsed as a core outcome measure for disease-specific HRQOL in PsA clinical trials. PsAID12 discrimination and improvement thresholds will be studied in future RCT.
Test-retest reliability and convergent validity of a computer based hand function test protocol in people with arthritis.
OBJECTIVES: A computer based hand function assessment tool has been developed to provide a standardized method for quantifying task performance during manipulations of common objects/tools/utensils with diverse physical properties and grip/grasp requirements for handling. The study objectives were to determine test-retest reliability and convergent validity of the test protocol in people with arthritis. METHODS: Three different object manipulation tasks were evaluated twice in forty people with rheumatoid arthritis (RA) or hand osteoarthritis (HOA). Each object was instrumented with a motion sensor and moved in concert with a computer generated visual target. Self-reported joint pain and stiffness levels were recorded before and after each task. Task performance was determined by comparing the object movement with the computer target motion. This was correlated with grip strength, nine hole peg test, Disabilities of Arm, Shoulder, and Hand (DASH) questionnaire, and the Health Assessment Questionnaire (HAQ) scores. RESULTS: The test protocol indicated moderate to high test-retest reliability of performance measures for three manipulation tasks, intraclass correlation coefficients (ICCs) ranging between 0.5 to 0.84, p<0.05. Strength of association between task performance measures with self- reported activity/participation composite scores was low to moderate (Spearman rho <0.7). Low correlations (Spearman rho < 0.4) were observed between task performance measures and grip strength; and between three objects' performance measures. Significant reduction in pain and joint stiffness (p<0.05) was observed after performing each task. CONCLUSION: The study presents initial evidence on the test retest reliability and convergent validity of a computer based hand function assessment protocol in people with rheumatoid arthritis or hand osteoarthritis. The novel tool objectively measures overall task performance during a variety of object manipulation tasks done by tracking a computer based visual target. This allows an innovative method of assessing performance than considering the time taken to complete a task or relying on subjective measures of self-reports on a limited range of objects and tasks covered. In addition, joint pain and stiffness levels before and after a manipulation task are tracked, which is lacking in other hand outcome measures. Performance measures during a broad range of object manipulation tasks relate to many activities relevant to life role participation. Therefore, task performance evaluation of common objects, utensils, or tools would be more valuable to gauge the difficulties encountered in daily life by people with arthritis. Future studies should consider a few revisions of the present protocol and evaluate a number of different objects targeting strength, fine, and gross dexterity based tasks for a broader application of the tool in arthritis populations.
An In-School-Based Program of Combined Fine Motor Exercise and Educational Activities for Children with Neurodevelopmental Disorders.
This article introduces a game-based rehabilitation platform designed to integrate training of fine motor skills and cognitive functions. A novel computer interface device was developed that can effectively replace a standard computer mouse when doing exercises to rehabilitate hand function. This smart device converts signals from miniature motion sensors to signals equivalent to that of a computer mouse. In this way, nearly any object or utensil can be changed to function exactly as a computer mouse, simply by attaching the motion sensor. Multiple objects with varied sizes, shapes, weights, and functional demands for precision can be used for exercise and to practice a variety of gross or fine motor skills, and, importantly, while playing fun computer games. The platform was designed to work with modern and common computer games, which have a broad range of movement speeds and accuracy levels, cognitive activities (puzzles, choices, distractors), and educational content. The platform includes a designed assessment game with advanced data logging for electronic monitoring. Data analysis methods have been developed to quantify performance metrics that provide insights into the quality, efficiency, and skill of a child and thus mean to conduct trend analyses that indicate how the child is performing over time.
Task-oriented training with computer gaming in people with rheumatoid arthritis or hand osteoarthritis: A quasi-mixed methods pilot study
Background: A computer game based Telerehabilitation platform has been developed to provide a seamless system for hand exercise and assessment in home settings for people with arthritis. The exercise program involves task-oriented training of real life object manipulation tasks performed with computer gaming. The platform will also be integrated with a telemonitoring, computer game based hand function assessment application. Objectives: 1) To determine test-retest reliability and convergent validity of the assessment application protocol in people with rheumatoid arthritis or hand osteoarthritis, 2) To conduct a pilot randomized controlled trial for assessing the feasibility, and therapeutic effects of the task-oriented training compared to conventional hand exercises, and 3) To qualitatively evaluate participants’ experiences on their respective exercise programs. Methods: Performance during three different object manipulation tasks was evaluated by the assessment application protocol on 40 people with arthritis. The performance measures were correlated with other common hand function measures. A six-week pilot randomized trial was conducted on 16 individuals with arthritis. The Arthritis Hand Function Test (AHFT), the Disabilities of Arm, Shoulder and Hand (DASH) questionnaire, exercise compliance and task performance during three object manipulation tasks were the clinical outcomes. Focus group interviews were conducted on seven participants who had before received their home exercise programs. Results: The protocol demonstrated moderate to high test-retest reliability (ICCs between 0.5-0.84) of performance measures. Spearman correlation coefficients (rho) between task performance measures and other measures of hand function were low to moderate (0.4 < rho < 0.5 to 0.7). The pilot trial was not successful in terms of participant recruitment but demonstrated feasibility of study procedures, resources, and management. Except for two dexterity sub-scales of the AHFT, there were no significant differences in other clinical measures. Exercise compliance was >85% in both groups. The qualitative study provided initial evidence on the appropriateness, acceptance, perceived benefits, and a few practical difficulties in performing each exercise program. Conclusions: The hand function assessment application warrants validation in a variety of object manipulation tasks and in different patient populations. In order to proceed to a full-fledged trial, additional recruitment strategies, and revisions in the inclusion criteria must be considered.
Exercise is fun? You’re kidding right?
http://www.cihr-irsc.gc.ca/e/47017.html
Mediating Effect of Changes in Hand Impairments on Hand Function in Patients With Rheumatoid Arthritis: Exploring the Mechanisms of an Effective Exercise Program.
OBJECTIVE: To determine whether the effect of the Strengthening and Stretching for Rheumatoid Arthritis of the Hand (SARAH) exercise program on hand function was mediated by changes in the proposed active ingredients: strength, dexterity, and/or range of motion. METHODS: The SARAH intervention included exercises hypothesized to improve potential mediators of grip strength, pinch strength, wrist flexion, wrist extension, finger flexion, finger extension, thumb opposition, and dexterity, which would theoretically improve self-reported hand function. All variables were measured at baseline and at 4 and 12 months. Structural equation modeling was used to assess mediation on change in hand function via change in potential mediators. RESULTS: Change in grip strength partially mediated change in hand function. Grip strength mediated 19.4% (95% confidence interval 0.9%, 37.8%) of the treatment effect. CONCLUSION: Improvements in grip strength at 4 months are likely to mediate improved hand function at 12 months. The role of joint mobility exercises is less clear and is likely influenced by the choice of measurement tools for both mobility and function outcomes. More robust measurements of wrist and hand mobility for patients with rheumatoid arthritis may be necessary to determine the relationship between this variable and self-reported hand function. Using a large trial data set, we have demonstrated that techniques used to target grip strength are key active ingredients of the SARAH exercise program and mediate its effect.
Web-based rehabilitation interventions for people with rheumatoid arthritis: A systematic review.
BACKGROUND: Rehabilitation approaches for people with rheumatoid arthritis include joint protection, exercises and self-management strategies. Health interventions delivered via the web have the potential to improve access to health services overcoming time constraints, physical limitations, and socioeconomic and geographic barriers. The objective of this review is to determine the effects of web-based rehabilitation interventions in adults with rheumatoid arthritis. METHODS: Randomised controlled trials that compared web-based rehabilitation interventions with usual care, waiting list, no treatment or another web-based intervention in adults with rheumatoid arthritis were included. The outcomes were pain, function, quality of life, self-efficacy, rheumatoid arthritis knowledge, physical activity and adverse effects. Methodological quality was assessed using the Cochrane Risk of Bias tool and quality of evidence with the Grading of Recommendations Assessment, Development and Evaluation approach. RESULTS: Six source documents from four trials ( n = 567) focusing on self-management, health information or physical activity were identified. The effects of web-based rehabilitation interventions on pain, function, quality of life, self-efficacy, rheumatoid arthritis knowledge and physical activity are uncertain because of the very low quality of evidence mostly from small single trials. Adverse effects were not reported. CONCLUSION: Large, well-designed trials are needed to evaluate the clinical and cost-effectiveness of web-based rehabilitation interventions in rheumatoid arthritis.
An Online Hand Exercise Intervention for Adults With Rheumatoid Arthritis (mySARAH): Design, Development, and Usability Testing.
BACKGROUND: The Strengthening and Stretching for Rheumatoid Arthritis of the Hand (SARAH) program is a tailored, progressive 12-week exercise program for people with hand problems due to rheumatoid arthritis. The program was shown to be clinically and cost-effective in a large clinical trial and is recommended by the UK National Institute for Health and Care Excellence (NICE) guidelines for rheumatoid arthritis in adults. OBJECTIVE: We have developed an online version of the SARAH program (mySARAH) to make the SARAH program widely accessible to people with rheumatoid arthritis. The purposes of this study were to develop mySARAH and to evaluate and address its usability issues. METHODS: We developed mySARAH using a three-step process and gaining feedback from patient contributors. After initial development, mySARAH was tested in two iterative usability cycles in nine participants using a simplified think-aloud protocol and self-reported questionnaires. We also evaluated if participants executed the SARAH exercises correctly after watching the exercise videos included on the website. RESULTS: A preliminary version of mySARAH consisting of six sessions over a 12-week period and delivered via text, exercise videos, images, exercise plan form, exercise calendar, and links to additional information on rheumatoid arthritis was developed. Five participants (1 male; 4 females; median age 64 years) and four participants (four females; median age 64.5 years) took part in the first and second usability testing cycles respectively. Usability issues identified from Cycle 1 such as having a navigation tutorial video and individualised feedback on pain levels were addressed prior to Cycle 2. The need for more instructions to complete the mySARAH patient forms was identified in Cycle 2 and was rectified. Self-reports from both cycles indicated that participants found the program useful and easy to use and were confident in performing the SARAH exercises themselves. Eight of the nine participants correctly demonstrated all the exercises. CONCLUSIONS: mySARAH is the first online hand exercise intervention for people with rheumatoid arthritis. We actively involved target users in the development and usability evaluation and ensured mySARAH met their needs and preferences.