[German translation and linguistic validation of the modified short questionnaire to assess health-enhancing physical activity (mSQUASH) for patients with axial spondyloarthritis (axSpA)]. / Übersetzung und sprachliche Validierung des modifizierten-Short QUestionnaire to Assess Health-enhancing physical activity (mSQUASH) ins Deutsche für Patienten mit axialer Spondyloarthritis (axSpA).

BACKGROUND: Patients with axial spondyloarthritis (axSpA) often experience chronic pain and inflammation, resulting in physical impairments, reduced mobility and decreased physical activity. The modified short questionnaire to assess health-enhancing physical activity (mSQUASH) was developed to assess daily physical activity in patients with axSpA. OBJECTIVE: To translate, cross-culturally adapt and linguistically validate the original mSQUASH into German for patients with axSpA. METHODS: The original mSQUASH was translated from Dutch into German using a multistep process (Beaton method) with forward-backward translations into German by bilingual Dutch-German lay people and experts. Any remaining discrepancies were resolved by a scientific committee, resulting in a prefinal German version. Field testing with cognitive debriefing interviews with patients with axSpA from diverse backgrounds led to a final German version. RESULTS: Minor discrepancies, primarily related to formalities, semantic errors and syntax were found during translations. These were addressed, resulting in slight wording modifications. The prefinal German version was validated through cognitive debriefing by 10 patients with axSpA, confirming its linguistic validity and equivalence to the Dutch version. CONCLUSION: Overall, this study confirmed the final German mSQUASH as a comprehensive measurement instrument for daily physical activity. It can now be used as a patient-reported outcome by German patients with axSpA. This can enable cross-linguistic comparisons and expanding its utility across language barriers.

The exercise-app Axia for axial spondyloarthritis enhances the home-based exercise frequency in axial spondyloarthritis patients - A cross-sectional survey.

BACKGROUND: Patients with axial spondyloarthritis (axSpA) benefit from regular home-based exercise (HbE). In spite of recommendations, a relevant proportion of German axSpA patients does not adhere to recommended HbE practices. To enhance HbE care, we developed the novel digital therapeutic (DTx) "Axia" compliant with the European medical device regulation (MDR). Axia offers a modern app-based HbE solution with patient educative content and further integrated features. OBJECTIVE: We aimed to assess Axia's efficacy, attractiveness, and functionality through a survey among axSpA-patients involved in the first user tests. METHODS: A mixed-method online questionnaire with 38 items was administered to 37 axSpA volunteers after using Axia. Numeric rating scales (NRS) and likelihood scales were primarily used. RESULTS: HbE frequency significantly increased from a median of 1 day/week to 6 days/week (p < 0.001) by using Axia. Existing HbE practitioners also increased their frequency (median of 4 days/week before, 6 days/week with Axia, p < 0.05). Axia received a median rating of 5 out of 5 stars. On NRS scales, Axia scored a median of 9 for intuitiveness and design, and a median of 8 for entertainment. 64.9% reported improved range of motion, 43.2% reported reduced pain, and 93.6% enhanced disease-specific knowledge. All users recommended Axia to other patients. CONCLUSION: Axia increases axSpA patients HbE frequency, possibly due to its good intuitiveness and design, leading to reduction in pain and subjective improvement of range of motion. This warrants further investigation in large randomized controlled interventional trials to establish its efficacy conclusively and patients adherence to HbE.

Work participation in patients with axial spondyloarthritis: high prevalence of negative workplace experiences and long-term work impairment.

INTRODUCTION: Axial spondyloarthritis (axSpA) is a chronic inflammatory disease that typically affects people in their second and third decades of life, which are important years for establishing a professional career. We aim to study outcomes of work participation (WP) and their associations with demographic and clinical confounders, in addition to prevalence of negative workplace experiences in axSpA. METHODS: In total, 770 patients with axSpA participated in the multicentre, observational ATTENTUS-axSpA survey in Germany. Demographic information, clinical parameters and patient-related outcomes (including disease activity and function) with a focus on WP were prospectively recorded. RESULTS: A high prevalence of negative workplace experiences was reported among the 770 patients analysed. Overall, 23.4% of patients were not employed and 6.5% received disability pensions. Current work cessation was prevalent in 120 patients, and 28 of those were out of work for 10 years or longer. Of the 590 currently employed patients, 31.9% reported absenteeism and 35.9% reported presenteeism for >1 month within the past year. Multivariate logistic regression identified low disease activity (Bath Ankylosing Spondylitis Disease Activity Index), better physical function (Bath Ankylosing Spondylitis Functional Index) and better global functioning (Assessment of SpondylAarthritis International Society-Health Index) as the main predictors for unimpaired WP (n=242). Importantly, biological treatment, disease duration, age, sex, education level and body mass index were not reliable predictors. DISCUSSION: Despite improvements in pharmacological treatment options, we still observed substantially impaired WP in patients with axSpA. These data emphasise the high unmet need for targeted strategies to provide improved medical and social care.

[Apps in rheumatology : Is there a need for an app in therapy for axial spondyloarthritis?] / Apps in der Rheumatologie : Bedarf es einer App in der Therapie der axialen Spondyloarthritis?

BACKGROUND: Digital health applications/apps (DiGA) are entering many medical disciplines and have the potential to revolutionize patient care. In rheumatology, the use for axial spondyloarthritis (axSpA) would be conceivable in the form of an exercise app. Therefore, a representative survey among axSpA patients was conducted to determine the need for an axSpA exercise app. MATERIALS AND METHODS: An anonymous online survey among axSpA patients of the German Bechterew's Disease Association was conducted using a questionnaire; data were analysed using Excel, and GraphPad Prism. RESULTS: Four hundred and thirty-five axSpA patients participated in the survey. Eighty-four percent of the participants responded that there is a need to develop an axSpA-specific exercise app, and the same proportion want to use it. Patients under 60 years, patients under 60 years on biologics or Janus kinase inhibitor therapy, and patients with frequent back pain reported a greater need than their respective control subgroups (p < 0.001 in each case). CONCLUSION: The development of an exercise app for axSpA is considered necessary by a large proportion of the patients; younger and more intensively treated patients appear to have a greater need.

Treat-to-target strategy with secukinumab as a first-line biological disease modifying anti-rheumatic drug compared to standard-of-care treatment in patients with active axial spondyloarthritis: protocol for a randomised open-label phase III study, AScalate.

INTRODUCTION: In patients with axial spondyloarthritis (axSpA), biological disease-modifying anti-rheumatic drugs (bDMARDs) are recommended to those with inadequate response or contraindications to non-steroidal anti-inflammatory drugs (NSAIDs). In case of failure of the first bDMARD, a switch within the class or to other bDMARD is recommended. Despite these treatment options, there is no optimal treat-to-target (T2T) strategy. This study aims to evaluate the efficacy of a T2T strategy in patients with axSpA, with secukinumab as a first-line bDMARD, compared with standard-of-care (SOC) treatment. METHODS AND ANALYSES: This is a randomised, parallel-group, open-label, multicentre ongoing study in patients with axSpA who are naïve to bDMARD and who have had an inadequate response to NSAIDs. The study will include an 8-week screening period, a 36-week treatment period and a 20-week safety follow-up period. At baseline, patients will be randomised (1:1) to T2T or SOC group. In the T2T group, patients will be treated with secukinumab 150 mg subcutaneous (s.c.) weekly until week 4 and then at week 8. For non-responders (patients without Ankylosing Spondylitis Disease Activity Score [ASDAS] clinically important improvement; change from baseline ≥1.1) at week 12, dose will be escalated to 300 mg s.c. every 4 weeks until week 24. Non-responders at week 24 will be switched to adalimumab biosimilar 40 mg s.c. every 2 weeks until week 34. In the SOC group, patients will receive treatment at the discretion of the physician. The primary endpoint is the proportion of patients achieving an Assessment in SpondyloArthritis International Society 40% (ASAS40) response at week 24. ETHICS AND DISSEMINATION: The study is being conducted as per the ethical principles of the Declaration of Helsinki and after approval from independent ethics committees/institutional review boards. The first results are expected to be published in early 2022. TRIAL REGISTRATION NUMBER: This study is registered with ClinicalTrials.gov, NCT03906136.

Ankylosing spondylitis self-help organisations - do members differ from non-members?

OBJECTIVES: Joining a patient self-help organisation is recommended for patients with ankylosing spondylitis (AS). The objective was to compare AS patients who are members of a self-help organisation with non-members regarding disease specific and patient personality aspects, and make inferences on potential benefits of membership. METHODS: A comprehensive questionnaire regarding demographics, smoking habits, acquisition of information about the disease, disease activity, functioning, patient satisfaction, treatment, sick leave, work disability and educational level was distributed to members of the German AS self-help organisation and to non-member AS patients. RESULTS: In total, 1273 patients responded. Significant differences regarding age and disease duration led us to match members 2:1 to non-members. In the matched population (n=549), members had a higher level of education, felt more often well-informed about the disease, had less often physically demanding jobs, and smoked less than non-members. Members were more often treated with NSAIDs and less often with TNF-blockers suggesting more severe disease in non-members. While the level of disease activity was similar (BASDAI 4.1 vs. 4.2), members had a better functional status (BASFI 3.5 vs. 3.9) and significantly less days on sick leave during the last year (15.1 days vs. 31.2 days). Days on sick leave increased with increasing BASFI significantly more strikingly in non-members than in members. CONCLUSION: AS patients who are members of an AS self-help organisation have a higher educational level and are much better informed about the disease. Inferences on disease outcome measures, however, are hampered by potential confounders.

[Competition in healthcare and its implications for the patient]. / Wettbewerb im Gesundheitswesen--Konsequenzen für den Patienten.

From the patient's perspective there is no competition (at least none that has a positive effect on him)! In Germany a rather good medicine is being increasingly sacrificed on the altar of economics.