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Trials within Cohorts (TwiCs) is a promising design to make randomized trials more efficient. Cohort participants are asked for consent to be randomized into future low-risk interventions tested within the cohort. To enable TwiCs in the Swiss HIV Cohort Study, we added this “randomization consent” to the protocol and approached cohort participants subsequently for written consent. This study describes the TwiCs implementation process. We used a mixed methods design to evaluate the implementation process. We used cohort data to characterize participants accepting and declining randomization consent. We conducted a cross-sectional survey with cohort physicians to gather opinions and experiences regarding the TwiCs design. We did semistructured interviews with involved stakeholders (physicians, research personnel, participants, and ethics committee members) to get insights about attitudes, barriers, and facilitators implementing the randomization consent. In addition, we performed observations in cohort visits where the randomization consent was offered. Between July 2024 and July 2025, among 5297 cohort participants approached, 3067 (57.9%) accepted and 734 (13.8%) declined the randomization consent. In 1496 (28.2%) cases the decision was postponed to the next visit. Male sex, younger age, higher education, being consulted by a steady physician for at least three visits, and shorter cohort participation time showed higher acceptance rates. Interviewed participants cited fear of additional effort and a lack of interest in research as reasons for declining consent. The overall perception of TwiCs among cohort physicians and research personnel was positive. They recognized the potential to simplify the conduct of trials, especially to test low-risk interventions. Ethical concerns on the TwiCs consent procedure were rare. However, an explicit randomization consent was considered necessary by members of ethical committees while several physicians and participants felt positive about randomizing without explicit consent. The roll-out of the randomization consent was facilitated by well-trained, motivated personnel, and seamless integration into clinical routine. Main barriers for physicians in the consenting process were language barriers, participant difficulty understanding the concept, and time constraints due to tight consultation schedules. The implementation of the TwiCs design, including the roll-out of a randomization consent in an existing, large-scale cohort, is feasible. The acceptance rate among participants was high. •Over 3000 participants signed a randomization consent in the Swiss HIV Cohort Study.•The acceptance rate of the randomization consent among participants was high.•This enables Trials within Cohorts (TwiCs) in the SHCS.•The perception of TwiCs among physicians and research personnel was positive.•Main barriers: language barrier, time barrier, complexity of TwiCs.

Background Among people living with HIV, there has been a shift of focus from HIV-related health issues to cardiovascular diseases and cancer. For both, tobacco smoking is a major but insufficiently addressed etiological factor. Evidence from randomized trials suggests that nicotine substitute products such as e-cigarettes and nicotine patches can reduce tobacco smoking and its associated health burden. However, most previous smoking cessation trials primarily included people who are motivated to quit smoking and focused on testing a single nicotine substitute product. The effectiveness of offering a menu of nicotine substitute products to tobacco smokers regardless of their willingness to quit smoking (“opt-out” approach) is unknown. Methods Reduce tobacco use in people living with HIV in Switzerland (RETUNE, NCT06789692) is a pragmatic, 1:1 randomized, multicenter, superiority clinical trial using the Trials within Cohorts (TwiCs) design within the Swiss HIV Cohort Study. RETUNE assesses the effectiveness of offering a menu of different nicotine substitute products, namely electronic cigarettes, nicotine pouches, and nicotine patches, versus usual care. Cohort participants are eligible if they smoke more than one tobacco cigarette per day, do not use any of the substitute products, and have signed the randomization consent following the TwiCs design. Participants randomized to the intervention may choose any of the offered substitutes to be used free of charge for 6 months or decline the offer. Overall, we plan to recruit 972 participants. The primary outcome is tobacco abstinence at 6 months measured as participant-reported past 7-day prevalence abstinence. The primary outcome will be assessed in the intention-to-treat set using a logistic regression model adjusted for region, men having sex with men, current drug users, and number of cigarettes per day at baseline. Secondary outcomes are long-term smoking cessation rates and tobacco-associated health outcomes. Discussion RETUNE started recruitment in February 2025 and is currently ongoing. RETUNE using the TwiCs design will clarify the effectiveness of a preference-based opt-out smoking cessation intervention among people living with HIV. Trial registration Clinicaltrials.gov NCT06789692. Registered on January 17th, 2025. The manuscript is aligned with the registry. https://clinicaltrials.gov/study/NCT06789692?cond=NCT06789692&rank=1

Background: Surgically treated proximal femoral fractures in geriatric patients are a major debilitating condition, with continuously rising numbers, impacting patients and the healthcare system. Models of care based on orthogeriatric co-management (OGCM) have suggested promising clinical outcomes compared with the standard of care (SOC) model in the treatment of frail elderly patients. Methods: A retrospective cohort study investigating clinical outcomes in two comparable cohorts of patients aged 75 and older, who underwent surgical treatment for proximal femoral fractures in 2023 was conducted. Included individuals all originated from the same geographic area, therefore presenting a unique cohort. The cohorts were differentiated by the perioperative care protocols implemented: an OGCM protocol (n = 147) versus a SOC protocol (n = 143). The main outcome measures were readmission, revision, and mortality rates at 30 days and one-year post-surgery, as well as the length of hospital stay. Results: Findings revealed a positive impact for patients treated under the OGCM protocol, with a significant reduction in the length of hospital stay (6 vs. 7 days, p = 0.001), while no consistent differences were observed in readmission (36.2% vs. 39.7%, p = 0.676), surgical revision (8.4% vs. 12.4%, p = 0.485), and mortality (24.1% vs. 31.7%, p = 0.781) rates one-year after surgery. Conclusions: Despite the absence of significant differences in major outcomes such as mortality, readmission, and surgical revision between the two protocols, the implementation of a more resource-intensive multidisciplinary care pathway resulted in a significant reduction in hospital length of stay. Beyond its clinical value, this improvement may contribute to reducing the burden on healthcare staff and support the sustainability of hospital systems facing increasing pressure.

Background: The global number of operatively treated proximal femoral fractures is steadily growing, driven by the demographic shift toward an increasingly elderly, frail, and comorbid population. This clinical condition profoundly impacts not only patient health but also the finances of healthcare systems. The aim of this economic analysis was to investigate the impact on direct costs of orthogeriatric co-management (OGCM) compared to standard of care (SOC). Methods: A retrospective analysis was conducted investigating two comparable cohorts of patients aged 75 and above, originating from the exact same geographic area, who underwent surgical treatment for proximal femoral fractures in 2023. The two cohorts differed in their perioperative care protocols: one followed an OGCM (n = 143) protocol, while the other adhered to a SOC protocol (n = 141). Economic data were retrieved from the centralised finance department managing the two hospital sites under investigation. Results: The findings revealed that the OGCM protocol was associated with direct costs that were not higher (CHF 16,019 vs. CHF 16,713, p = 0.78) compared to SOC, despite higher daily costs in the OGCM cohort (CHF 2504 vs. CHF 2202, p < 0.0001). This difference was largely driven by a significantly shorter length of stay in the OGCM group (6 days vs. 7 days, p = 0.002). Conclusions: Optimising resource allocation through tailored geriatric care protocols suggests not only an improvement in clinical outcomes but also a reduction in economic burden, thereby alleviating pressure on the healthcare system.