Quality of reporting and nature of harms in clinical trials on supervised exercise in patients with rheumatoid arthritis or axial spondyloarthritis.

To describe the quality of reporting and the nature of reported harms in clinical studies on the effectiveness of supervised exercises in patients with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA). We performed a systematic review, searching eight databases up to February 2023. Randomized controlled trials (RCTs) evaluating supervised exercises in adults with RA or axSpA were considered eligible. Data on harms were extracted according to the CONSORT Harms 2022 Checklist. Among others, it was recorded if harms were prespecified or non-prespecified. Moreover, the nature of reported harms was listed. Forty RCTs were included for RA and 25 for axSpA, of which 29 (73%) and 13 (52%) reported information on harms. In 13 (33%) RCTs in RA and four (16%) in axSpA, the collection of harms outcomes was described in the methods section. Prespecified outcomes were reported by eight (RA) and two (axSpA) RCTs. Non-specified harms outcomes were reported by six (RA) and four (axSpA) RCTs. Prespecified harms outcomes included measures of pain, disease activity, inflammation, and structural joint changes. The nature of non-prespecified harms outcomes varied largely, with pain being most common. A considerable proportion of trials on supervised exercise in RA or axSpA does not or inadequately report harms outcomes. Pain was the most commonly reported prespecified or non-specified harm. For a considerate interpretation of the balance between benefits and harms of supervised exercise in RA or axSpA, use of the CONSORT Harms 2022 Checklist for the design, conduct and reporting of trials is advocated.

The feasibility, facilitators, and barriers in the initial implementation phase of 'good life with osteoarthritis in Denmark' (GLA:D®) in Switzerland: a cross-sectional survey.

BACKGROUND: The guideline-based, conservative, non-pharmacological management of hip and knee osteoarthritis in clinical practice has been insufficient in Switzerland until now. The implementation of "Good Life with Osteoarthritis in Denmark" (GLA:D®), a programme designed to address this evidence-performance gap, was started in 2019 in Switzerland. This study investigated the acceptance and practicality of the GLA:D® Switzerland programme and identified the facilitators and barriers to its implementation, to support the development of tailored implementation strategies. METHODS: This is a non-experimental observational study. A cross-sectional survey was performed among the physiotherapists (PTs) of the first five GLA:D® Switzerland certification courses, using the Measurement Instrument for Determinants of Innovations (MIDI) to identify the facilitators and barriers. Descriptive statistics were calculated, and qualitative content analysis was used for open-ended questions. RESULTS: In the online survey, 86 GLA:D® certified PTs participated (response rate: 61%). The majority of 51 PTs (63.7%) worked in private practices. Of the responding PTs 58 (78.4%) were satisfied with the general concept of the GLA:D® Switzerland programme. Practicality was evaluated positively, particularly the second and third individual session (n = 40 PTs, 83.3%), the 40 m Fast-paced Walk Test (43, 89.6%), the 30 s Chair Stand Test (45, 93.8%), and the exercise programme (40, 83.3%). The marketing (12, 15%), the 'data entry' (5, 10.4%), 'register the patient' (7, 14.6%), and the digital patient questionnaire (9, 14.2%) were rated less positively. In total, 12 facilitators and 12 barriers were identified. The barriers were mainly related to adopting user, e.g., perceived personal disadvantages. Barriers were also found in the organisational context, e.g., time available. Facilitators were associated with the GLA:D® Switzerland programme itself, e.g., completeness, relevance for patients, and the adopting user, e.g., self-efficacy, and in the organisational context, e.g., material resources and facilities. Topics related to the socio-political context were raised in the answers to the open-ended questions, e.g., general awareness level of the GLA:D® Switzerland programme and patient recruitment. CONCLUSION: The acceptance, practicality and facilitators identified from the initial implementation are encouraging. However, the identified barriers and activities rated with low practicality require tailored strategies to support a successful implementation of the GLA:D® Switzerland programme.

[Translation of the 2018 EULAR recommendations for physical activity in people with inflammatory arthritis and osteoarthritis and linguistic validation in German-speaking countries with healthcare professionals]. / Übersetzung der 2018 EULAR Empfehlungen zu körperlicher Aktivität von Menschen mit entzündlich-rheumatischen und degenerativen Erkrankungen ins Deutsche und sprachliche Validierung im deutschsprachigen Raum mit medizinischen Fachpersonen.

BACKGROUND: Regular physical activity is beneficial for people with rheumatic diseases and one of the cornerstones in its management. Based on the international recommendations of the World Health Organization for the general population, the "2018 EULAR recommendations for physical activity in people with inflammatory arthritis and osteoarthritis" provide evidence-based recommendations on the prescription, performance, and implementation of physical activity exercises in this population for the first time. AIM: Translation of the 2018 EULAR recommendations into German and linguistic validation in Germany, Austria and Switzerland. METHODS: A professional translation of the EULAR recommendations into the German language was performed and revised by German-speaking experts from all three countries. The translation was validated by healthcare professionals consisting of rheumatologists, occupational therapists, physiotherapists, nurses, and medical assistants in a field test. In each of the three countries, eight structured interviews were conducted on comprehensibility, wording, completeness, and feasibility. The experts then discussed changes until consensus was reached and indicated the level of agreement with the final translation. RESULTS: The translation of the EULAR recommendations was substantially revised. Based on the results of the cognitive test, formulations were adapted in order to increase comprehensibility. The level of agreement between 10 (SD 0.0) and 8.9 (SD 1.5) was very high. DISCUSSION: The final German version of the EULAR recommendations is comprehensible and accepted across all three German-speaking countries. It can help to improve the structure and clarity of the handling of physical activity and promote physical activity for healthcare providers and patients.

Cross-cultural adaptation and psychometric testing of the Dutch and German versions of the Evaluation of Daily Activity Questionnaire in people with rheumatoid arthritis.

The Evaluation of Daily Activity Questionnaire (EDAQ) is a detailed patient-reported outcome measure of activity ability. The objective of this research was to assess the linguistic and cross-cultural validity and psychometric properties of the EDAQ in rheumatoid arthritis for Dutch and German speakers. The EDAQ was translated into Dutch and German using standard methods. A total of 415 participants (Dutch n = 252; German n = 163) completed two questionnaires about four weeks apart. The first included the EDAQ, Health Assessment Questionnaire (HAQ) and 36-item Short-Form v2 (SF-36v2) and the second, the EDAQ only. We examined construct validity using Rasch analysis for the two components (Self-Care and Mobility) of the Dutch and German EDAQ. Language invariance was also tested from the English version. We examined internal consistency, concurrent and discriminant validity and test-retest reliability in the 14 EDAQ domains. The Self-Care and Mobility components satisfied Rasch model requirements for fit, unidimensionality and invariance by language. Internal consistency for all 14 domains was mostly good to excellent (Cronbach's alpha ≥ 0.80). Concurrent validity was mostly strong: HAQ rs = 0.65-0.87; SF36v2 rs = - 0.61 to - 0.87. Test-retest reliability was excellent [ICC (2,1) = 0.77-0.97]. The EDAQ has good reliability and validity in both languages. The Dutch and German versions of the EDAQ can be used as a measure of daily activity in practice and research in the Netherlands and German- speaking countries.

Perceived Barriers to and Facilitators of an Injury Prevention Program Among Professional Male Ice Hockey Players and Staff Members.

CONTEXT: Injury prevention programs for the lower extremities are effective in team-sport athletes. OBJECTIVE: To identify barriers and facilitators among professional ice hockey players and staff members for adhering to an injury prevention program. DESIGN: Cross-sectional survey. SETTING AND PARTICIPANTS: A questionnaire about barriers and facilitators related to knowledge/perceptions, beliefs, adoption, and habits about injury prevention was filled out by Swiss professional male ice hockey players and staff members. MAIN OUTCOME MEASURES: Frequencies of ratings were calculated and binary logistic regression analysis was applied to predict a relationship between a high/low perceived benefit of an injury prevention program and player characteristics. RESULTS: Knowledge, perceived benefit, and relevance of injury prevention as well as awareness of high risk of injuries in ice hockey were identified as important facilitators. Players' habit of exercise performance was identified as a barrier. Program understanding of staff members was identified as a facilitator and barrier. No significant relationships were observed between a high/low perceived benefit of an injury prevention program and age (P = .85), nationality (P = .53), level of education (P = .63), National League experience (P = .50), or occurrence of lower-extremity injuries in the previous season (P = .10). CONCLUSIONS: Players and staff members clearly rated perceived benefits of an injury prevention program, which can be considered an important facilitator of the uptake and adoption of such a program in ice hockey teams. Players should be educated about well-performed injury prevention exercises. Staff members should be educated about the aim of a regular injury prevention program. An injury prevention program might be implemented in players of all ages, levels of education, and experience in the National League, irrespective of previous injuries. Identified barriers and facilitators should be addressed when implementing an injury prevention program in a setting of professional ice hockey teams in the future.

Development of a model on factors affecting instrumental activities of daily living in people with mild cognitive impairment - a Delphi study.

INTRODUCTION: The level of function of instrumental activities of daily living (IADL) is crucial for a person's autonomy. A clear understanding of the nature of IADL and its limitations in people with mild cognitive impairment (MCI) is lacking. Literature suggests numerous possible influencing factors, e.g. cognitive function, but has not considered other domains of human functioning, such as environmental factors. Our aim was to develop a comprehensive model of IADL functioning that depicts the relevant influencing factors. METHODS: We conducted a four-round online Delphi study with a sample of international IADL experts (N = 69). In the first round, panelists were asked to mention all possible relevant cognitive and physical function factors, as well as environmental and personal factors, that influence IADL functioning. In the subsequent rounds, panelists rated the relevance of these factors. Consensus was defined as: 1) ≥70% agreement between panelists on a factor, and 2) stability over two successive rounds. RESULTS: Response rates from the four rounds were high (83 to 100%). In the first round, 229 influencing factors were mentioned, whereof 13 factors reached consensus in the subsequent rounds. These consensual factors were used to build a model of IADL functioning. The final model included: five cognitive function factors (i.e. memory, attention, executive function, and two executive function subdomains -problem solving / reasoning and organization / planning); five physical function factors (i.e. seeing functions, hearing functions, balance, gait / mobility functions and functional mobility functions); two environmental factors (i.e. social network / environment and support of social network / environment); and one personal factor (i.e. education). CONCLUSIONS: This study proposes a comprehensive model of IADL functioning in people with MCI. The results from this Delphi study suggest that IADL functioning is not merely affected by cognitive function factors, but also by physical function factors, environmental factors and personal factors. The multiplicity of factors mentioned in the first round also underlines the individuality of IADL functioning in people with MCI. This model may serve as a basis for future research in IADL functioning in people with MCI.

Cross-cultural adaptation and validation of the Amsterdam Instrumental Activities of Daily Living questionnaire short version German for Switzerland.

BACKGROUND: Instrumental Activities of Daily Living (IADL) limitations are associated with reduced health-related quality of life for people with mild cognitive impairment (MCI). For these people, the assessment of IADL is crucial to the diagnostic process, as well as for the evaluation of new interventions addressing MCI. The Amsterdam IADL Questionnaire Short Version (A-IADL-Q-SV) is an established assessment tool with good psychometric properties that has been shown to be robust to cultural differences in Western countries. The aims of this study were to: (1) cross-culturally adapt and validate the A-IADL-Q-SV for the German-speaking population of Switzerland; (2) investigate its cultural comparability; and (3) evaluate further psychometric properties. METHODS: The A-IADL-Q-SV German was pretested on clinicians and participants in a memory clinic setting. The psychometric properties and cultural comparability of the questionnaire were investigated in memory clinic settings including participants with MCI or mild dementia, as well as participants with normal cognition recruited from the community. Item response theory (IRT) was applied to investigate measurement invariance by means of differential item functioning to assess item bias. Additionally, the test-retest reliability on scale level, the construct validity through hypothesis testing and the discriminant validity of the A-IADL-Q-SV German were evaluated. RESULTS: Ninety-six informants of participants with normal cognition, MCI or mild dementia completed the A-IADL-Q-SV German. The basic assumptions for IRT scoring were met. No meaningful differential item functioning for culture was detected between the Swiss and Dutch reference samples. High test-retest reliability on scale level (ICC 0.93; 95% CI 0.9-0.96) was found. More than 75% of the observed correlations between the A-IADL-Q-SV German and clinical measures of cognition and functional status were found to be in the direction and of the magnitude hypothesized. The A-IADL-Q-SV German was shown to be able to discriminate between participants with normal cognition and MCI, as well as MCI and mild dementia. CONCLUSIONS: The A-IADL-Q-SV German is a psychometrically robust measurement tool for a Swiss population with normal cognition, MCI and mild dementia. Thus, it provides a valuable tool to assess IADL functioning in clinical practices and research settings in Switzerland. Trial registration This study was registered retrospectively in July 2019 on ClinicalTrials.gov (NCT04012398).

Effectiveness of multicomponent lower extremity injury prevention programmes in team-sport athletes: an umbrella review.

OBJECTIVE: To identify which exercise combinations are most effective as part of a lower extremity injury prevention programme for team-sport athletes. DESIGN: Umbrella review. DATA SOURCES: A comprehensive literature search was performed in PubMed, Scopus, Cochrane Library and PEDro databases. Studies published between January 2000 and March 2017 were included in this umbrella review. STUDY ELIGIBILITY CRITERIA: Moderate to high-quality systematic reviews that investigated the effectiveness of a combination of two or more exercise components, that is, strength, agility, plyometrics, balance, stretching, technique, warm-up and functional activity, regarding injury incidence/rate of lower extremity injuries in team-sport athletes. The methodological quality of the included systematic reviews was independently assessed by two reviewers using the Assessing the Methodological Quality of Systematic Reviews measurement tool and the Grading of Recommendations Assessment, Development and Evaluation guidelines were used to assess the overall quality of evidence for particular outcomes. RESULTS: Twenty-four systematic reviews met the inclusion criteria. Multicomponent exercise interventions were effective in reducing the injury incidence/rate of lower extremity, knee, ACL and ankle injuries, but not groin injuries. Strength and balance exercise components were included in 10 of 11 effective injury prevention programmes for the lower extremity, knee, ACL and ankle injuries. SUMMARY/CONCLUSION: Lower extremity injury prevention programmes in team sports are effective in preventing lower extremity, knee, ACL and ankle injuries. Lower extremity muscle strength and balance exercises should be prioritised in lower extremity injury prevention programmes for team-sport athletes.

2018 EULAR recommendations for physical activity in people with inflammatory arthritis and osteoarthritis.

Regular physical activity (PA) is increasingly promoted for people with rheumatic and musculoskeletal diseases as well as the general population. We evaluated if the public health recommendations for PA are applicable for people with inflammatory arthritis (iA; Rheumatoid Arthritis and Spondyloarthritis) and osteoarthritis (hip/knee OA) in order to develop evidence-based recommendations for advice and guidance on PA in clinical practice. The EULAR standardised operating procedures for the development of recommendations were followed. A task force (TF) (including rheumatologists, other medical specialists and physicians, health professionals, patient-representatives, methodologists) from 16 countries met twice. In the first TF meeting, 13 research questions to support a systematic literature review (SLR) were identified and defined. In the second meeting, the SLR evidence was presented and discussed before the recommendations, research agenda and education agenda were formulated. The TF developed and agreed on four overarching principles and 10 recommendations for PA in people with iA and OA. The mean level of agreement between the TF members ranged between 9.8 and 8.8. Given the evidence for its effectiveness, feasibility and safety, PA is advocated as integral part of standard care throughout the course of these diseases. Finally, the TF agreed on related research and education agendas. Evidence and expert opinion inform these recommendations to provide guidance in the development, conduct and evaluation of PA-interventions and promotion in people with iA and OA. It is advised that these recommendations should be implemented considering individual needs and national health systems.

EULAR definition of arthralgia suspicious for progression to rheumatoid arthritis.

BACKGROUND: During the transition to rheumatoid arthritis (RA) many patients pass through a phase characterised by the presence of symptoms without clinically apparent synovitis. These symptoms are not well-characterised. This taskforce aimed to define the clinical characteristics of patients with arthralgia who are considered at risk for RA by experts based on their clinical experience. METHODS: The taskforce consisted of 18 rheumatologists, 1 methodologist, 2 patients, 3 health professionals and 1 research fellow. The process had three phases. In phase I, a list of parameters considered characteristic for clinically suspect arthralgia (CSA) was derived; the most important parameters were selected by a three-phased Delphi approach. In phase II, the experts evaluated 50 existing patients on paper, classified them as CSA/no-CSA and indicated their level of confidence. A provisional set of parameters was derived. This was studied for validation in phase III, where all rheumatologists collected patients with and without CSA from their outpatient clinics. RESULTS: The comprehensive list consisted of 55 parameters, of which 16 were considered most important. A multivariable model based on the data from phase II identified seven relevant parameters: symptom duration <1 year, symptoms of metacarpophalangeal (MCP) joints, morning stiffness duration ≥60 min, most severe symptoms in early morning, first-degree relative with RA, difficulty with making a fist and positive squeeze test of MCP joints. In phase III, the combination of these parameters was accurate in identifying patients with arthralgia who were considered at risk of developing RA (area under the receiver operating characteristic curve 0.92, 95% CI 0.87 to 0.96). Test characteristics for different cut-off points were determined. CONCLUSIONS: A set of clinical characteristics for patients with arthralgia who are at risk of progression to RA was established.

Experiences of general practitioners, home care nurses, physiotherapists and seniors involved in a multidisciplinary home-based fall prevention programme: a mixed method study.

BACKGROUND: The feasibility of effective fall prevention programmes (FPPs) for use in daily clinical practice needs to be assessed in the specific healthcare settings. The aim of this study was to explore the perceived benefits and barriers of an evidence-based, home-based pilot FPP among the involved seniors, general practitioners (GPs), home care nurses (HCNs) and physiotherapists (PTs), in order to develop tailored implementation strategies. METHODS: The study was a mixed method study using an 'exploratory sequential design'. In the initial qualitative sequence, semi-structured interviews were performed with four participants from each group and analysed using a deductive content analysis. In the successive quantitative sequence, target group specific postal surveys were conducted with all participants. The triangulation of both steps allowed merging the in-depth experiences from the interviews with the general findings from the survey. RESULTS: In this evaluation study participated 17 seniors (mean age 79.7 (SD +/-6.2) years). 40 GPs, 12 HCNs and four PTs. All were satisfied with the organization and processes of the FPP. The main benefit, perceived by each target group, was the usefulness of the FPP in detecting risk of falling at the senior's home. A low number of recruiting GPs and HCNs, divergent opinions of the health professionals towards the aim of the FPP as well as no perceived need for changes by the seniors were the most important barriers to the participation of (more) seniors. CONCLUSIONS: Multidisciplinary home-based fall prevention is a useful approach to detect the risk of falling in seniors. The barriers identified need to be resolved through tailored strategies to facilitate the successful nationwide implementation of this pilot FPP.

Development and Validation of a Pain Behavior Assessment in Patients with Chronic Low Back Pain.

PURPOSE: High levels of pain behavior adversely affect the success of multidisciplinary rehabilitation of patients with chronic nonspecific low back pain (CNSLBP). Functional capacity evaluation (FCE) assessment should detect high levels of pain behavior to prevent the inclusion of unsuitable patients to functional rehabilitation programs. The aim of this study was to develop a Pain Behavior Assessment (PBA) and to evaluate its construct validity. METHODS: The PBA was developed by experts in the field and is literature-based. Inclusion criteria for participants of the validation study were: CNSLBP, age 20-60 years, referral for fitness-for-work evaluation. The PBA was applied by physiotherapists during FCE. Rasch analysis was performed to evaluate the construct validity of the PBA. Internal consistency was indicated by the person separation index (PSI), which corresponds to Cronbach's alpha. RESULTS: 145 male (72.5%) and 55 female patients were included. Rasch analysis removed 11 items due to misfit and redundancy, resulting in a final PBA of 41 items. Item mean fit residual was -0.33 (SD 1.06) and total item Chi square 100.39 (df = 82, p = 0.08). The PSI value was 0.83. DIF analysis for age and gender revealed no bias. CONCLUSIONS: The PBA is a valid assessment tool to describe pain behavior in CNSLBP patients. The high PSI-value justifies the use of the PBA in individuals. The PBA may help to screen patients for high levels of pain behavior.

EULAR recommendations for patient education for people with inflammatory arthritis.

OBJECTIVES: The task force aimed to: (1) develop evidence-based recommendations for patient education (PE) for people with inflammatory arthritis, (2) identify the need for further research on PE and (3) determine health professionals' educational needs in order to provide evidence-based PE. METHODS: A multidisciplinary task force, representing 10 European countries, formulated a definition for PE and 10 research questions that guided a systematic literature review (SLR). The results from the SLR were discussed and used as a basis for developing the recommendations, a research agenda and an educational agenda. The recommendations were categorised according to level and strength of evidence graded from A (highest) to D (lowest). Task force members rated their agreement with each recommendation from 0 (total disagreement) to 10 (total agreement). RESULTS: Based on the SLR and expert opinions, eight recommendations were developed, four with strength A evidence. The recommendations addressed when and by whom PE should be offered, modes and methods of delivery, theoretical framework, outcomes and evaluation. A high level of agreement was achieved for all recommendations (mean range 9.4-9.8). The task force proposed a research agenda and an educational agenda. CONCLUSIONS: The eight evidence-based and expert opinion-based recommendations for PE for people with inflammatory arthritis are intended to provide a core framework for the delivery of PE and training for health professionals in delivering PE across Europe.

Facilitators, barriers and support needs to GLA:D exercise adherence - a mixed method study.

BACKGROUND: Knee and hip osteoarthritis (OA) are among the most common musculoskeletal joint diseases worldwide. International guidelines recommend exercise and education as first-line interventions for their management. The Good Life with osteoArthritis Denmark (GLA:D) programme aims to achieve self-management using group exercise and education sessions. It also encourages participants to stay physically active and perform GLA:D exercises (GE) twice weekly after programme end. This study investigated the participants' self-reported level of physical activity (PA) and self-reported adherence to the GE between five and 17 months after completion of the GLA:D programme and also explored the barriers, facilitators and support needs to achieve long-term adherence to GE. METHODS: A mixed method study using an exploratory sequential design was performed. A qualitative phase, involving semi-structured interviews and a focus group, led to the development of a questionnaire on participants' level of PA, as well as ratings of the barriers, facilitators and support needs for the achievement of long-term adherence to GE. In a second quantitative phase, the survey was conducted online with former GLA:D participants from Switzerland. Descriptive statistical analysis and a group comparison between adherent and non-adherent participants to the GE were performed using Fisher's exact test, odds ratio, and confidence interval. RESULTS: Eleven former GLA:D participants attended the interviews and focus group, and former GLA:D participants (30% response rate) participated in the survey. Of these, 84% (n = 285) reported to reach the recommended level of PA and 53% (n = 178) GE adherence. The top barrier to GE adherence was no/little self-discipline to perform GE (40%, n = 112) and the top facilitator was GE are easy to perform (93%, n = 300). The top 3 items regarding support needs to enhance GE adherence were a shortened version (max. 30 min) of the GE home programme (75%, n = 255), monthly continuation of small GE groups under GLA:D physiotherapists' supervision (65%, n = 221), and monitoring with regular testing of individual progress (65%, n = 221). CONCLUSIONS: The top barriers and facilitators should be considered by those responsible for the GLA:D programme and may need to be specifically addressed during and after the programme. The development of a shortened version of the GLA:D programme, a post-GLA:D group, and monitoring with regular testing seem crucial for enhancing GE adherence. CLINICAL TRIAL REGISTRATION: not applicable.

Active over 45: a step-up jogging programme for inactive female hospital staff members aged 45+.

BACKGROUND: Inactive individuals face motivational obstacles for becoming and remaining physically active. Therefore, sustainable physical activity promotion programmes tailored to reach inactive individuals are needed. The aim of this study was to test the role of motivation and the effect and feasibility of a training programme. METHODS: We enrolled physically inactive female hospital staff members aged 45 and older in an uncontrolled exercise trial. Follow-up assessments were at 3 and 12 months. The primary outcome was running distance (Cooper test). Secondary outcomes were level of physical activity (Freiburger Physical Activity Questionnaire) and body mass index. RESULTS: Out of 1249 female hospital staff, 275 classified themselves as inactive and 250 (91%) of them were interested in the exercise programme. Of these, 68 (27%; mean age 53.2 years) agreed to participate in our study and 47 (69%) completed the programme. Average running distance increased by 255.70 m [95% confidence interval (CI) 208.09-303.31] at 3-month follow-up with a sustained benefit at 12-month follow-up (194.02; 95% CI 143.75-244.47). Physical activity level increased by 1152.52 kcal week(-1) (95% CI 703.73-1601.32) at 3 months with a sustained benefit (1279.10 kcal week(-1), 95% CI 826.80-1731.40) after 12 months. Notably, baseline motivation to become physically active was not associated with change in physical performance or physical activity level during the programme. CONCLUSION: The 3-month step-up jogging programme is a feasible and effective exercise intervention for physically inactive, middle-aged female hospital staff members. The intervention leads to sustained benefits independently of motivation to become more physically active.

HLA-B27 as a predictor of effectiveness of treatment with TNF inhibitors in axial spondyloarthritis: data from the Swiss Clinical Quality Management Registry.

OBJECTIVE: To explore the impact of the human leucocyte antigen (HLA)-B27 on the effectiveness of tumor necrosis factor inhibitors (TNFi) in patients with axial spondyloarthritis (axSpA). METHODS: A total of 1109 patients with available HLA-B27 status (831 B27+ patients and 278 B27- patients) fulfilling the Assessment of Spondyloarthritis international Society classification criteria for axSpA from the prospective Swiss Clinical Quality Management Registry initiating a first TNFi were included. Drug retention was investigated with multiple adjusted Cox proportional hazard models with imputation of missing values. Multiple-adjusted logistic regression analyses were used to assess the proportion of patients reaching 50% reduction in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI50) at 1 year. RESULTS: B27+ and B27- patients differed with regard to age, sex, BASDAI, C-reactive protein (CRP), body mass index, enthesitis, uveitis, and classification status. After adjustment for potential confounders for the relationship between HLA-B27 and drug effectiveness (sex and family history of spondyloarthritis), a higher risk of drug discontinuation was found in B27- patients (HR 1.53, 95% CI 1.27-1.83). This difference decreased after additional adjustment for parameters which may act as mediators (HR 1.30, 95% CI 1.30-1.55). Male sex and elevated C-reactive protein (CRP) levels were consistently associated with longer retention. Comparable results were obtained for BASDAI50 responses. CONCLUSION: The HLA-B27 genotype is an important predictor of treatment effectiveness. Male sex and CRP seem, however, to better describe variability of response in individual patients. This data may help avoiding potential discrimination of B27- individuals with regard to TNFi initiation. Key Points • HLA-B27 is a predictor of effectiveness of TNF inhibitors in axial spondyloarthritis. • Variability of response in individual patients is better defined by sex and objective markers of disease activity, such as C-reactive protein.

Understanding beliefs related to physical activity in people living with axial Spondyloarthritis: a theory-informed qualitative study.

BACKGROUND: People living with axial Spondyloarthrtis (axSpA) have an increased risk of cardiovascular diseases, which can be reduced by regular physical activity (PA) and its subset of cardiorespiratory training (CRT). To fulfil their crucial role in PA promotion, physiotherapists and other health professionals need to understand the beliefs that people living with axSpA possess concerning general PA and CRT. The aim of this study is to explore these behavioural, normative and control beliefs. METHODS: A qualitative descriptive design approach was chosen. Five semi-structured focus group interviews with 24 individuals living with axSpA were performed. Data was analysed using structured thematic qualitative content analysis. RESULTS: People with axSpA possessed multifaceted behavioural, normative and control beliefs concerning general PA and CRT. Behavioural beliefs revealed a positive attitude towards general PA, with participants mentioning numerous physical, psychological, and social benefits and only few risks. However, the conceptual difference between general PA and CRT, and the relevance of CRT, was unclear to some participants. Normative beliefs were expressed as the beliefs of significant others that influenced their motivation to comply with such beliefs, e.g. spouses, other people living with axSpA, rheumatologists. Regarding control beliefs, general PA and CRT were both mentioned as effective self-management strategies to control the disease. From experience, a high level of self-discipline, as well as technology, were shown to be useful. CONCLUSIONS: General PA is understood to be an important self-management strategy for people with axSpA and most participants build general PA into their daily routines. They believe that general PA beneficially impacts personal health and wellbeing. However, some participants are unaware of the difference between general PA and CRT and the important impact that this difference could have on their health. The consequences of CRT promotion for people living with axSpA should be the subject of further research.

Evaluation of the strategy for implementing the GLA:D programme in Switzerland: protocol for an implementation-effectiveness hybrid type 3 design study with a mixed-method approach.

INTRODUCTION: International guidelines recommend the use of exercise, education and weight reduction, when appropriate, as first-line treatment for the conservative management of knee osteoarthritis (OA). These guidelines have not been applied systematically in Switzerland, resulting in an evidence-performance gap. After an analysis of available programmes, the Good Life with osteoArthritis Denmark (GLA:D) programme was determined as the most applicable exercise and education programme for its implementation in Switzerland. The implementation of GLA:D Switzerland OA was initiated to encourage the wider implementation of the clinical guideline recommendations and to improve conservative management of knee OA. The aim of this study protocol is to describe the evaluation of the implementation strategy and its impact on implementation, service and clinical outcomes; as well as to identify contributing barriers and facilitators. METHODS AND ANALYSIS: The Implementation Research Logic Model will be used to evaluate the strategy and analyse its impact on the implementation outcomes by means of a mixed methods approach. This protocol outlines the proposed measures, data sources and strategies for the evaluation. Predefined implementation outcomes will help to identify the implementation impact and analyse barriers and facilitators systematically. The study population will be the healthcare professionals who are involved in the conservative management of knee OA in Switzerland, that is, physiotherapists and medical doctors, and their patients. ETHICS AND DISSEMINATION: The use of the registry data containing data of patients participating in the GLA:D Switzerland OA programme does not fall within the scope of the Swiss Human Research Act (BASEC-Nr. Req-2019-00274). However, all participants involved in the evaluation will be asked to give informed written consent and all measures are taken to protect data and privacy of participants. Research findings will be submitted to journals relevant for the topic. TRIAL REGISTRATION NUMBER: Not applicable.

Lessons learned from a pilot implementation of physical activity recommendations in axial spondyloarthritis exercise group therapy.

BACKGROUND: The Ankylosing Spondylitis Association of Switzerland (SVMB) aimed to implement physical activity recommendations (PAR) within their exercise groups (EGs). The PAR promote exercise in all fitness dimensions at the correct dose. To implement the PAR within EGs, they were translated into a new EG concept with five key activities: (a) training for supervising physiotherapists (PTs), (b) correctly dosed exercises in all fitness dimensions, (c) exercise counselling, (d) bi-annual fitness assessments, and (e) individual exercise training, in addition to EG. All these activities were realized in close coordination with SVMB management. OBJECTIVES: To analyse the implementation success by evaluating adherence/fidelity, feasibility, and satisfaction at the patient, PTs, and organisational level. METHODS: The five key activities of the new EG concept were developed, executed, and assessed after 6 months. The primary outcomes for implementation success were adherence of patients to the recommended exercise behaviour, self-reported by electronic diary; fidelity of PTs to the new concept, self-reported by diary; SVMB organisational changes. Secondary outcomes were feasibility and satisfaction with the new EG concept at all three levels. The tertiary outcome, to evaluate the effectiveness of PAR, was patient fitness, assessed through fitness assessments. RESULTS: 30 patients with axSpA (ten women, mean age 58 ± 9 years) and four PTs (three women, mean age 46 ± 9 years) participated. The patients' self-reporting of adherence to the PAR was insufficient (43%), possibly due to technical problems with the electronic dairy. The PTs' fidelity to the new EG concept was satisfactory. On all levels, the new concept was generally perceived as feasible and useful for supporting personalised exercise.The frequency of exercise counselling and the fitness assessments was found by patients and PTs to be too high and rigid. Patients' cardiorespiratory fitness [ES 1.21 (95%CI 0.59, 1.89)] and core strength [ES 0.61 (95%CI 0.18, 1.06)] improved over the 6 months. CONCLUSIONS: The pilot implementation of PAR showed acceptance and satisfaction to be sufficient, thus confirming the need for evidence-based EGs, provided by a patient organisation in order to support active PA behaviour. However, adaptations are necessary to increase its feasibility for nationwide implementation. TRIAL REGISTRATION: SNCTP, SNCTP000002880. Registered 31 May 2018, https://www.kofam.ch/en/snctp-portal/search/0/study/42491 .