Background: Falls and fractures are a major problem. Objectives: To investigate the clinical effectiveness and cost-effectiveness of alternative falls prevention interventions. Design: Three-arm, pragmatic, cluster randomised controlled trial with parallel economic analysis. The unit of randomisation was the general practice. Setting: Primary care. Participants: People aged ≥ 70 years. Interventions: All practices posted an advice leaflet to each participant. Practices randomised to active intervention arms (exercise and multifactorial falls prevention) screened participants for falls risk using a postal questionnaire. Active treatments were delivered to participants at higher risk of falling. Main outcome measures: The primary outcome was fracture rate over 18 months, captured from Hospital Episode Statistics, general practice records and self-report. Secondary outcomes were falls rate, health-related quality of life, mortality, frailty and health service resource use. Economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year and incremental net monetary benefit. Results: Between 2011 and 2014, we randomised 63 general practices (9803 participants): 21 practices (3223 participants) to advice only, 21 practices (3279 participants) to exercise and 21 practices (3301 participants) to multifactorial falls prevention. In the active intervention arms, 5779 out of 6580 (87.8%) participants responded to the postal fall risk screener, of whom 2153 (37.3%) were classed as being at higher risk of falling and invited for treatment. The rate of intervention uptake was 65% (697 out of 1079) in the exercise arm and 71% (762 out of 1074) in the multifactorial falls prevention arm. Overall, 379 out of 9803 (3.9%) participants sustained a fracture. There was no difference in the fracture rate between the advice and exercise arms (rate ratio 1.20, 95% confidence interval 0.91 to 1.59) or between the advice and multifactorial falls prevention arms (rate ratio 1.30, 95% confidence interval 0.99 to 1.71). There was no difference in falls rate over 18 months (exercise arm: rate ratio 0.99, 95% confidence interval 0.86 to 1.14; multifactorial falls prevention arm: rate ratio 1.13, 95% confidence interval 0.98 to 1.30). A lower rate of falls was observed in the exercise arm at 8 months (rate ratio 0.78, 95% confidence interval 0.64 to 0.96), but not at other time points. There were 289 (2.9%) deaths, with no differences by treatment arm. There was no evidence of effects in prespecified subgroup comparisons, nor in nested intention-to-treat analyses that considered only those at higher risk of falling. Exercise provided the highest expected quality-adjusted life-years (1.120), followed by advice and multifactorial falls prevention, with 1.106 and 1.114 quality-adjusted life-years, respectively. NHS costs associated with exercise (£3720) were lower than the costs of advice (£3737) or of multifactorial falls prevention (£3941). Although incremental differences between treatment arms were small, exercise dominated advice, which in turn dominated multifactorial falls prevention. The incremental net monetary benefit of exercise relative to treatment valued at £30,000 per quality-adjusted life-year is modest, at £191, and for multifactorial falls prevention is £613. Exercise is the most cost-effective treatment. No serious adverse events were reported. Limitations: The rate of fractures was lower than anticipated. Conclusions: Screen-and-treat falls prevention strategies in primary care did not reduce fractures. Exercise resulted in a short-term reduction in falls and was cost-effective. Future work: Exercise is the most promising intervention for primary care. Work is needed to ensure adequate uptake and sustained effects. Trial registration: Current Controlled Trials ISRCTN71002650. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 34. See the NIHR Journals Library website for further project information.

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Background: There is lack of standardisation in assessment tools used in geriatric medicine research, which makes pooling of data and cross-study comparisons difficult. Methods: We conducted a modified Delphi process to establish measures to be included within core and extended datasets for geriatric medicine research in the United Kingdom (UK). This included three complete questionnaire rounds, and one consensus meeting. Participants were selected from attendance at the NIHR Newcastle Biomedical Research Centre meeting, May 2019, and academic geriatric medicine e-mailing lists. Literature review was used to develop the initial questionnaire, with all responses then included in the second questionnaire. The third questionnaire used refined options from the second questionnaire with response ranking. Results: Ninety-eight responses were obtained across all questionnaire rounds (Initial: 19, Second: 21, Third: 58) from experienced and early career researchers in geriatric medicine. The initial questionnaire included 18 questions with short text responses, including one question for responders to suggest additional items. Twenty-six questions were included in the second questionnaire, with 108 within category options. The third questionnaire included three ranking, seven final agreement, and four binary option questions. Results were discussed at the consensus meeting. In our position statement, the final consensus dataset includes six core domains: demographics (age, gender, ethnicity, socioeconomic status), specified morbidities, functional ability (Barthel and/or Nottingham Extended Activities of Daily Living), Clinical Frailty Scale (CFS), cognition, and patient-reported outcome measures (dependent on research question). We also propose how additional variables should be measured within an extended dataset. Conclusions: Our core and extended datasets represent current consensus opinion of academic geriatric medicine clinicians across the UK. We consider the development and further use of these datasets will strengthen collaboration between researchers and academic institutions.

Background: Osteoporosis is common in older adults leading to fragility fractures at enormous individual and economic cost. Improving long-term adherence with bisphosphonate treatments reduces fracture risk, but adherence rates for first-line oral bisphosphonate alendronate remains low. Although alternative treatment regimens, including annual intravenous infusions are available, patient acceptability remains unclear. Therefore, understanding patients' acceptability and engagement in different bisphosphonate regimens is important to ensure optimal treatment benefits. Methods: Semi-structured interviews were conducted with 78 patients with a mean age of 69.9 years, who had taken or received bisphosphonates for osteoporosis within the last 24 months. Data analysis included iterative categorisation and used the theoretical framework of acceptability (TFA) to compare the acceptability of treatments regimens. Results: Treatment acceptability and engagement were influenced by the extent to which patients understood the prescribed treatment, and evidence of the treatment working. Acceptability and engagement were compromised when treatment was perceived as burdensome, personal costs were incurred, and patients' values were incompatible with the regimen. The balancing of these factors contributed to patients' ability to cope with the treatment and their emotional responses. Intravenous treatment was generally perceived as easier to understand, more effective, less burdensome with fewer opportunity costs, and a preferable regimen compared with oral bisphosphonates. Conclusions: Annual intravenous zoledronate bisphosphonate treatment was generally more acceptable to patients, perceived as more straightforward to engage in, although a small portion of patients on oral bisphosphonates were satisfied with treatment. Further research is needed to identify how acceptability and engagement can be optimised.