Efficacy and Safety of CT-P13 in Inflammatory Bowel Disease after Switching from Originator Infliximab: Exploratory Analyses from the NOR-SWITCH Main and Extension Trials.

BACKGROUND: The NOR-SWITCH main and extension trials demonstrated that switching from originator to biosimilar infliximab (CT-P13) is efficacious and safe across six diseases. However, a subgroup analysis of Crohn's disease (CD) in the main trial displayed a close to significant difference favouring originator infliximab, and more scientific data have therefore been requested. OBJECTIVE: The aim was to assess treatment efficacy, safety, and immunogenicity in an explorative subgroup analysis in CD and ulcerative colitis (UC) in the NOR-SWITCH trials. PATIENTS AND METHODS: The 52-week, randomised, non-inferiority, double-blind, multicentre, phase 4 NOR-SWITCH study was followed by a 26-week open extension trial where all patients received treatment with CT-P13. Treatment efficacy, safety, and immunogenicity in CD and UC were assessed throughout the 78-week study period. RESULTS: The main and extension trials included 155 and 93 patients with CD and 93 and 80 patients with UC, respectively. Demographic and baseline characteristics were comparable in both treatment arms within patient groups. There were no differences in the main and extension trials regarding changes in activity indices, C-reactive protein, faecal calprotectin, patient's and physician's global assessment of disease activity and patient-reported outcome measures in CD and UC. Moreover, comparable results were also demonstrated for trough serum levels, presence of anti-drug antibodies, and reported adverse events. CONCLUSION: Efficacy, safety, and immunogenicity of both the originator and biosimilar infliximab were comparable in CD and UC in the NOR-SWITCH main and extension trials. These explorative subgroup analyses confirm that there are no significant concerns related to switching from originator infliximab to CT-P13 in CD and UC. TRIAL REGISTRATION: ClinicalTrials.gov, number NCT02148640.

Structured Goal Planning and Supportive Telephone Follow-up in Rheumatology Care: Results From a Pragmatic, Stepped-Wedge, Cluster-Randomized Trial.

OBJECTIVE: To evaluate patient-reported health effects of an add-on structured goal-planning and supportive telephone follow-up rehabilitation program compared with traditional rehabilitation programs in patients with rheumatic diseases. METHODS: In this pragmatic stepped-wedge, cluster-randomized, controlled trial, 389 patients with rheumatic diseases recruited from 6 rehabilitation centers received either traditional rehabilitation or traditional rehabilitation extended with an add-on program tailored to individual needs. The add-on program comprised a self-management booklet, motivational interviewing in structured individualized goal planning, and 4 supportive follow-up phone calls after discharge. Data were collected by questionnaires on admission and discharge from rehabilitation stay, and at 6 months and 12 months after discharge. The primary outcome was health-related quality of life (HRQoL) measured by the Patient Generated Index (range 0-100, where 0 = low). Secondary outcomes included patient-reported health status, self-efficacy, pain, fatigue, global disease activity, and motivation for change. The main statistical analysis was a linear repeated measures mixed model performed on the intent-to-treat population using all available data. RESULTS: A significant treatment effect of the add-on intervention on HRQoL was found on discharge (mean difference 3.32 [95% confidence interval 0.27, 6.37]; P = 0.03). No significant between-group differences were found after 6 or 12 months. Both groups showed positive changes in HRQoL following rehabilitation, which gradually declined, although the values remained at higher levels after 6 and 12 months compared with baseline values. CONCLUSION: The add-on program enhanced the short-term effect of rehabilitation with respect to patient-specific HRQoL, but it did not prolong the effect as intended.

The challenges of describing rehabilitation services: A discussion paper.

To apply the Classification of Service Organization in Rehabilitation (ICSO-R) classification of services to different target groups, include the user perspective, identify missing categories, and propose standardized descriptors for the categories from a Norwegian perspective. Expert-based consensus conferences with user involvement. Health professionals, stakeholders and users. Participants were divided into 5 panels, which applied the ICSO-R to describe the habilitation and rehabilitation services provided to children with cerebral palsy and people with Huntington's disease, acquired brain injuries (traumatic brain injuries and stroke) and painful musculoskeletal conditions. Based on the Problem/Population, Intervention, Comparison, Outcome (PICO) framework, the services were described according to the ICSO-R. Missing categories were identified. The ICSO-R was found to be feasible and applicable for describing a variety of services provided to different target groups in Norway, but the user perspective was lacking, categories were missing, and a need for standardized description of the categories was identified. The present work supports the need to produce an updated version of the ICSO-R and to encourage national and international discussion of the framework. The ICSO-R has the potential to become a tool for the standardized assessment of rehabilitation services. For such purposes, more standardized descriptions of subcategories are necessary.

Aiming for a healthier life: a qualitative content analysis of rehabilitation goals in patients with rheumatic diseases.

PURPOSE: To explore and describe rehabilitation goals of patients with rheumatic diseases during rehabilitation stays, and examine whether goal content changed from admission to discharge. METHOD: Fifty-two participants were recruited from six rehabilitation centers in Norway. Goals were formulated by the participants during semi-structured goal-setting conversations with health professionals trained in motivational interviewing. An inductive qualitative content analysis was conducted to classify and quantify the expressed goals. Changes in goal content from admission to discharge were calculated as percentage differences. Goal content was explored across demographic and contextual characteristics. RESULTS: A total of 779 rehabilitation goals were classified into 35 categories, within nine overarching dimensions. These goals varied and covered a wide range of topics. Most common at admission were goals concerning healthy lifestyle, followed by goals concerning symptoms, managing everyday life, adaptation, disease management, social life, and knowledge. At discharge, goals about knowledge and symptoms decreased considerably, and goals about healthy lifestyle and adaptation increased. The health profession involved and patient gender influenced goal content. CONCLUSIONS: The rehabilitation goals of the patients with rheumatic diseases were found to be wide-ranging, with healthy lifestyle as the most prominent focus. Goal content changed between admission to, and discharge from, rehabilitation stays. Implications for rehabilitation Rehabilitation goals set by patients with rheumatic diseases most frequently concern healthy lifestyle changes, yet span a wide range of topics. Patient goals vary by gender and are influenced by the profession of the health care worker involved in the goal-setting process. To meet the diversity of patient needs, health professionals need to be aware of their potential influence on the actual goal-setting task, which may limit the range of topics patients present when they are asked to set rehabilitation goals. The proposed framework for classifying goal content has the capacity to detect changes in goals occurring during the rehabilitation process, and may be used as a clinical tool during goal-setting conversations for this patient group.

Rehabilitation for patients with rheumatic diseases: Patient experiences of a structured goal planning and tailored follow-up programme.

OBJECTIVE: To explore the significance of the content of rehabilitation in terms of achieving a personal outcome, and to understand the significance of tailored follow-up interventions for individual efforts to prolong health behaviour change after rehabilitation. DESIGN: Semi-structured interviews with patients who had received an extended rehabilitation programme. All interviews were transcribed verbatim. A thematic analysis was applied. SUBJECTS: A purposeful sample of 18 patients with rheumatic diseases who had attended specialized multidisciplinary rehabilitation with an extended programme consisting of a self-help booklet, structured goal-setting talks and tailored follow-up calls based on motivational interviewing. RESULTS: Four overarching and interrelated themes were identified. Experienced Person-centred interventions represented a basis for the patients' motivation and personal outcomes. Confident self-management describes a new confident approach to exercise and illness management after rehabilitation with person-centred interventions. For many, this included reaching a different mindset, a change of illness perception. Continuity of the personal outcomes describes the importance of follow-up telephone calls to maintain the focus on goals and continued efforts. Building on established relationships and practising person-centred communication were essential. CONCLUSION: Tailoring of communication and rehabilitation interventions may be a premise for enhancing health behaviour, including a beneficial illness perception. Structured goal setting and follow-up telephone calls using motivational interviewing enhance motivation and may contribute to prolonged goal attainment.

Perceived quality of health care services among people with osteoarthritis - results from a nationwide survey.

OBJECTIVE: To assess the perceived quality of care received by people with osteoarthritis (OA) in Norway and explore factors associated with the quality of care. METHODS: A national survey in which members of the Norwegian Rheumatism Association with OA registered as their main diagnosis completed a questionnaire. The perceived quality of care was reported on a 17-item OsteoArthritis Quality Indicator questionnaire, covering both pharmacological and non-pharmacological aspects of OA care. In addition, the four-page questionnaire covered areas related to demographic characteristics, the location and impact of the OA, and utilization and satisfaction with health care services. The quality of care is calculated as pass rates, where the numerator represents the number of indicators passed and the denominator represents the number of eligible persons. RESULTS: In total, 1,247 participants (response rate 57%) completed the questionnaire. Mean age was 68 years (standard deviation 32) and 1,142 (92%) were women. Respondents reported OA in hand only (12.4%), hip only (7.3%), knee only (10.4%), in two locations (42%) or all three locations (27%). The overall OsteoArthritis Quality Indicator pass rate was 47% (95% confidence interval [CI] 46%-48%), and it was higher for pharmacological aspects (53% [51%-54%]) than for non-pharmacological aspects of care (44% [43%-46%]). The pass rate for the individual quality indicators ranged from 8% for "referral for weight reduction" to 81% for "receiving advice about exercises". Satisfaction with care was strongly associated with perceived quality. The pass rate for those who were "very satisfied" was 33% (25%-40%) higher than those who were "very unsatisfied" with care. CONCLUSION: While the OA patient seems to be rather satisfied with the perceived OA care, there is still room for improvement in the quality of care. Although the quality of care in the present study is somewhat higher than in other studies, less than 50% of the recommended care has been provided.

Evaluation of a structured goal planning and tailored follow-up programme in rehabilitation for patients with rheumatic diseases: protocol for a pragmatic, stepped-wedge cluster randomized trial.

BACKGROUND: Comprehensive rehabilitation, involving health professionals from various disciplines, is widely used as an adjunct to pharmacological and surgical treatment in people with rheumatic diseases. However, the evidence for the clinical- and cost-effectiveness of such interventions is limited, and the majority of those who receive rehabilitation are back to their initial health status six to 12 months after discharge. METHODS/DESIGN: To evaluate the goal attainment, health effects and cost-effectiveness of a new rehabilitation programme compared to current traditional rehabilitation programmes for people with rheumatic diseases, a stepped-wedge cluster randomized trial will be performed. Patients admitted for rehabilitation at six centres in the south-eastern part of Norway will be invited to participate. In the trial, six participating centres will switch from a control (current rehabilitation programme) to an intervention phase (the new rehabilitation programme) in a randomized order. Supported by recent research, the new programme will be a supplement to the existing programme at each centre, and will comprise four elements designed to enhance and support lifestyle changes introduced in the rehabilitation period: structured goal-planning, motivational interviewing, a self-help booklet and four follow-up telephone calls during the first five months following discharge. The primary outcome will be health-related quality of life and goal attainment, as measured by the Patient Generated Index directly before and after the rehabilitation stay, as well as after six and 12 months. Secondary outcomes will include self-reported pain, fatigue, a global assessment of disease activity and motivation for change (measured on 11-point numeric ratings scales), health-related quality of life as measured by the Short Form 36 Health Survey (SF-36) and utility assessed by the SF6D utility index.The main analysis will be on an intention to treat basis and will assess the clinical- and cost-effectiveness of the structured goal planning and tailored follow-up rehabilitation programme for patients with rheumatic diseases. DISCUSSION: The findings will constitute an important contribution to more cost-effective- and evidence-based rehabilitation services for people with rheumatic diseases. TRIAL REGISTRATION: ISRCTN91433175.