Mobilisation and mobility in clinical settings are essential to the recovery process after surgery and trauma-related hospital admission. In addition to personal support from physiotherapists and nursing staff, aids such as walkers are applied. Walkers equipped with smart features have the potential to benefit geriatric patients by facilitating routine clinical workflows and, where appropriate, by providing health professionals with information on gait patterns and vital parameters.

The overarching goal of this project is to develop an innovative smart walker for clinical use, guided by three objectives: (a) Identify the feature requirements of the smart walker from the perspectives of patients and health professionals, (b) Co-design the smart walker using a user-centred approach involving older patients, health professionals and clinical engineers and (c) Pilot-test the smart walker in real time with older patients admitted to German clinics.

We will employ a three-phased exploratory sequential mixed-methods approach in this project. Phase I explores potentially useful characteristics of a smart walker via a scoping literature review (part 1 of phase I) and a qualitative interview and observational study, including questionnaires on sociodemographic data and technology readiness, involving four to six patients and four to eight nurses and physiotherapists (part 2 of phase I). Phase II focuses on developing and validating a smart walker through a user experience design, with at least three iterative test cycles involving a minimum of three asymptomatic participants and three to seven potential users in each cycle. Phase III comprises a pilot study conducted at a University Hospital in Germany involving at least twelve patients. Data integration takes a data-building approach, combining qualitative and quantitative results in the final analysis to generate a comprehensive understanding and to create and refine insights into the feature needs and use of a smart walker by patients.

The study was approved by the Ethics Committee of University Medicine Halle, Germany (Approval No. 2025-032; date of approval: 03/04/2025). Study results will be disseminated through peer-reviewed journals and conferences.

The study protocol was registered at the Open Science Framework Platform (OSF, register number: 10.17605/OSF.IO/CTPF4).

Evaluate tofacitinib efficacy, safety and persistence by sex in rheumatoid arthritis (RA).

Post hoc analyses using data from phase III placebo-controlled randomised controlled trials (ORAL Scan, ORAL Sync and ORAL Standard).

ORAL Scan, ORAL Sync and ORAL Standard were global, multicentre trials conducted across 111, 114 and 115 sites, respectively.

The trials enrolled adults with active RA and prior inadequate response to methotrexate (ORAL Scan/ORAL Standard) or ≥1 conventional synthetic or biologic disease-modifying antirheumatic drug (ORAL Sync). Post hoc analyses included 2265 patients (1870 female and 395 male).

Patients received tofacitinib 5 mg or 10 mg two times a day, adalimumab or placebo.

Efficacy outcomes to month 12 included American College of Rheumatology (ACR)20, 50 and 70 responses, Disease Activity Score in 28 joints (DAS28) (erythrocyte sedimentation rate (ESR))-defined low disease activity (LDA) and remission, DAS28 (C reactive protein (CRP)) ≤3.2 and

At baseline, female patients had similar DAS28(CRP and ESR), slightly higher HAQ-DI and lower FACIT-F scores versus male patients (n=395). ORs for active treatments (tofacitinib and adalimumab) versus placebo were generally >1 for ACR20, 50 and 70 responses, DAS28(CRP) ≤3.2 and

In post hoc analyses, tofacitinib was efficacious across both sexes, with higher responses in males observed particularly for more stringent composite endpoints and patient-reported outcomes. Findings are generally consistent with studies of other advanced RA therapies. Safety and persistence were similar across sexes. Interpretation is limited by the small proportion of male patients (

NCT00847613, NCT00856544, NCT00853385, NCT00661661 and NCT00413699.