scholarly journals Economic evaluation of an Australian nurse home visiting programme: a randomised trial at 3 years

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e052156
Author(s):  
Shalika Bohingamu Mudiyanselage ◽  
Anna M H Price ◽  
Fiona K Mensah ◽  
Hannah E Bryson ◽  
Susan Perlen ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Home Visiting ◽  
Child Outcomes ◽  
Randomised Trial ◽  
Cost Effective ◽  
Cost Utility ◽  
Nurse Home Visiting ◽  
The Right ◽  
Child Age

ObjectivesTo investigate the additional programme cost and cost-effectiveness of ‘right@home’ Nurse Home Visiting (NHV) programme in relation to improving maternal and child outcomes at child age 3 years compared with usual care.DesignA cost–utility analysis from a government-as-payer perspective alongside a randomised trial of NHV over 3-year period. Costs and quality-adjusted life-years (QALYs) were discounted at 5%. Analysis used an intention-to-treat approach with multiple imputation.SettingThe right@home was implemented from 2013 in Victoria and Tasmania states of Australia, as a primary care service for pregnant women, delivered until child age 2 years.Participants722 pregnant Australian women experiencing adversity received NHV (n=363) or usual care (clinic visits) (n=359).Primary and secondary outcome measuresFirst, a cost–consequences analysis to compare the additional costs of NHV over usual care, accounting for any reduced costs of service use, and impacts on all maternal and child outcomes assessed at 3 years. Second, cost–utility analysis from a government-as-payer perspective compared additional costs to maternal QALYs to express cost-effectiveness in terms of additional cost per additional QALY gained.ResultsWhen compared with usual care at child age 3 years, the right@home intervention cost $A7685 extra per woman (95% CI $A7006 to $A8364) and generated 0.01 more QALYs (95% CI −0.01 to 0.02). The probability of right@home being cost-effective by child age 3 years is less than 20%, at a willingness-to-pay threshold of $A50 000 per QALY.ConclusionsBenefits of NHV to parenting at 2 years and maternal health and well-being at 3 years translate into marginal maternal QALY gains. Like previous cost-effectiveness results for NHV programmes, right@home is not cost-effective at 3 years. Given the relatively high up-front costs of NHV, long-term follow-up is needed to assess the accrual of health and economic benefits over time.Trial registration numberISRCTN89962120.

Economic evaluation of compression stockings for the prevention of venous leg ulcer recurrence in Ontario

2020 ◽  
Vol 29 (3) ◽  
pp. 141-151 ◽  
Author(s):  
Sandjar Djalalov ◽  
Shayan Sehatzadeh ◽  
David H Keast ◽  
William WL Wong
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Cost Effective ◽  
Cost Utility ◽  
Cost Utility Analysis ◽  
Ulcer Recurrence ◽  
Utility Analysis ◽  
Compression Stockings ◽  
Old Patients ◽  
Life Years

Objective: Approximately between 1.5 and 3.0 per 1000 people are affected by venous leg ulcers (VLUs). The treatment and management of VLUs is costly and recurrence is a major concern. There is evidence that compression stockings can reduce the rate of re-ulceration compared with no compression. We present the first cost-effective analysis of compression stockings in preventing recurrence of VLUs from the perspective of the Ontario healthcare system. Method: A cost-utility analysis with a five-year time horizon was conducted. Use of compression stockings was compared with usual care (no compression stockings). We simulated a hypothetical cohort of 65-year-old patients with healed VLUs, using a state-transition model. Model input parameters were obtained mainly from the published literature. We estimated quality-adjusted life years (QALYs) gained and direct medical costs. We conducted various sensitivity analyses. Results: Compared with usual care, compression stockings were associated with higher costs and increased QALYs. Cost-utility analysis showed that the incremental cost-effectiveness ratio of compression stockings was $23,864 per QALY gained compared with no compression stockings. The most influential drivers of cost-effectiveness were the utility value of healed VLUs, cost of stockings, number of stocking replacements, monthly prevention cost and the risk of VLU recurrence. Conclusion: Compared with usual care, compression stockings were cost-effective in preventing VLUs, using a willingness-to-pay threshold of $50,000. These observations were consistent even when uncertainty in model inputs and parameters were considered.

Economic rationale on the use of m-Health in uncontrolled hypertensive outpatients: from three months and beyond

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Ionov ◽  
O.V Zhukova ◽  
N.E Zvartau ◽  
A.O Konradi
Keyword(s):  
Cost Effectiveness ◽  
Incremental Cost ◽  
Usual Care ◽  
Cost Effective ◽  
Cost Utility ◽  
Scientific Data ◽  
Funding Source ◽  
Life Years ◽  
Cardiovascular Morbidity And Mortality

Abstract Background/Introduction Current scientific data show that blood pressure (BP) telemonitoring with/without additional counseling is rather effective in hypertension (HTN) management. However, cost-effectiveness and long-term social sequelae are lacking. This is because of diverse technologies and economic climate which make results highly heterogeneous across countries. Purpose To construct predictive model of long-term outcomes and to conduct the cost-effectiveness analysis of BP telemonitoring and remote counseling (BPTM) using m-Health in Russian population of outpatients with HTN. Methods Total of 240 patients were randomized (2:1) to either BPTM (n=160, mean age 47 y.o.) and to usual care (UC, n=80, mean age 49 y.o.) with baseline, three-month follow-up clinic visits combined with ambulatory BP measurement (ABPM). BPTM consisted of m-Health tool for patients, desktop module for clinicians. It enables BP data transfer and analysis, secure web chatting to support and counsel. Main outcomes were change in office, ambulatory systolic (S) BP and rate of BP control. A Markov cohort-based (1000 patients per study arm) model was developed and adopted a 10-year time horizon with 12-month time cycles. All patients started at a non-complicated HTN “well” state with a certain possibility of disease progression in a number of health states over a discrete time period. BPTM was compared with usual care in terms of 10-year healthcare costs, quality adjusted life years (QALY) using a Ministry of Health of Russian Federation perspective. Incremental cost-effectiveness ratio (ICER), incremental cost-utility ratio (ICUR) represented economic analysis. Results BPTM was associated with steeper decrease in office, ambulatory SBP (−16,8 mm Hg and −8,9 mm Hg, respectively; p<0,05) with the same treatment intensity (2,4 drugs per patient). There were 102 (64%) and 11 (14%) patients with fully controlled HTN in BPTM and UC groups, respectively (OR 11,03 95% CI [5,4–22,5]). An ICER of BPTM resulted in additional 11,1 EUR/1 mm Hg/year. It is expected that BPTM will be at least 76% cost-effective as per relevant Russian willingness-to-pay threshold. In a modelled 10-year period BPTM was life-saving (9,71 vs 9,6 life years gained) and cheap (cost of illness 1,5 mln vs 2,1 mln EUR). BPTM was also more valuable (8,31 versus 7,82 QALYs gained) so the ICUR was 3601,47 EUR/QALY gained. Cost-effectiveness was further confirmed by one-way deterministic sensitivity analysis. Conclusion BPTM seems to be clinically and economically effective when implemented into clinical practice. It provides greater BP reduction, improves BP control short-term. In a long-term it is likely to reduce cardiovascular morbidity and mortality in a cost-effective way. Larger randomized studies are needed to confirm these pilot results. Cost-effectiveness acceptability curve Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): The Russian Scientific Foundation

scholarly journals Enhanced recovery following hip and knee arthroplasty: a systematic review of cost-effectiveness evidence

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e032204 ◽  
Author(s):  
Mark G Pritchard ◽  
Jacqueline Murphy ◽  
Lok Cheng ◽  
Roshni Janarthanan ◽  
Andrew Judge ◽  
...  
Keyword(s):  
Systematic Review ◽  
Health Economic ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Enhanced Recovery ◽  
Cost Effective ◽  
Cost Utility ◽  
Risk Of Bias ◽  
Enhanced Recovery Pathways ◽  
Recovery Pathways

AbstractObjectivesTo assess cost-effectiveness of enhanced recovery pathways following total hip and knee arthroplasties. Secondary objectives were to report on quality of studies and identify research gaps for future work.DesignSystematic review of cost–utility analyses.Data sourcesOvid MEDLINE, Embase, the National Health Service Economic Evaluations Database and EconLit, January 2000 to August 2019.Eligibility criteriaEnglish-language peer-reviewed cost–utility analyses of enhanced recovery pathways, or components of one, compared with usual care, in patients having total hip or knee arthroplasties for osteoarthritis.Data extraction and synthesisData extracted by three reviewers with disagreements resolved by a fourth. Study quality assessed using the Consensus on Health Economic Criteria list, the International Society for Pharmacoeconomics and Outcomes Research and Assessment of the Validation Status of Health-Economic decision models tools; for trial-based studies the Cochrane Collaboration’s tool to assess risk of bias. No quantitative synthesis was undertaken.ResultsWe identified 17 studies: five trial-based and 12 model-based studies. Two analyses evaluated entire enhanced recovery pathways and reported them to be cost-effective compared with usual care. Ten pathway components were more effective and cost-saving compared with usual care, three were cost-effective, and two were not cost-effective. We had concerns around risk of bias for all included studies, particularly regarding the short time horizon of the trials and lack of reporting of model validation.ConclusionsConsistent results supported enhanced recovery pathways as a whole, prophylactic systemic antibiotics, antibiotic-impregnated cement and conventional ventilation for infection prevention. No other interventions were subject of more than one study. We found ample scope for future cost-effectiveness studies, particularly analyses of entire recovery pathways and comparison of incremental changes within pathways. A key limitation is that standard practices have changed over the period covered by the included studies.PROSPERO registration numberCRD42017059473.

scholarly journals OP0198-HPR A STRUCTURED MODEL FOR OA CARE IN PRIMARY HEALTHCARE IS A COST-EFFECTIVE ALTERNATIVE COMPARED TO USUAL CARE FOR PEOPLE WITH HIP AND KNEE OA

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 119-120
Author(s):  
N. Østerås ◽  
E. Aas ◽  
T. Moseng ◽  
L. Van Bodegom-Vos ◽  
K. Dziedzic ◽  
...  
Keyword(s):  
Usual Care ◽  
Primary Healthcare ◽  
Intervention Group ◽  
Cost Effective ◽  
Cost Utility ◽  
Control Group ◽  
Structured Model ◽  
Knee Oa ◽  
Cost Effective Alternative ◽  
The Cost

Background:To improve quality of care for patients with hip and knee osteoarthritis (OA), a structured model for integrated OA care was developed based on international treatment recommendations. A previous analysis of a cluster RCT (cRCT) showed that compared to usual care, the intervention group reported higher quality of care and greater satisfaction with care. Also, more patients were treated according to international guidelines and fulfilled recommendations for physical activity at the 6-month follow-up.Objectives:To assess the cost-utility of a structured model for hip or knee OA care.Methods:A cRCT with stepped-wedge cohort design was conducted in 6 Norwegian municipalities (clusters) in 2015-17. The OA care model was implemented in one cluster at the time by switching from “usual care” to the structured model. The implementation of the model was facilitated by interactive workshops for general practitioners (GPs) and physiotherapists (PTs) with an update on OA treatment recommendations. The GPs explained the OA diagnosis and treatment alternatives, provided pharmacological treatment when appropriate, and suggested referral to physiotherapy. The PT-led patient OA education programme was group-based and lasted 3 hours followed by an 8–12-week individually tailored resistance exercise programme with twice weekly 1-hour supervised group sessions (5–10 patients per PT). An optional 10-hours Healthy Eating Program was available. Participants were ≥45 years with symptomatic hip or knee OA.Costs were measured from the healthcare perspective and collected from several sources. Patients self-reported visits in primary healthcare at 3, 6, 9 and 12 months. Secondary healthcare visits and joint surgery data were extracted from the Norwegian Patient Register. The health outcome, quality-adjusted life-year (QALY), was estimated based on the EQ-5D-5L scores at baseline, 3, 6, 9 and 12 months. The result of the cost-utility analysis was reported using the incremental cost-effectiveness ratio (ICER), defined as the incremental costs relative to incremental QALYs (QALYs gained). Based on Norwegian guidelines, the threshold is €27500. Sensitivity analyses were performed using bootstrapping to assess the robustness of reported results and presented in a cost-effectiveness plane (Figure 1).Results:The 393 patients’ mean age was 63 years (SD 9.6) and 74% were women. 109 patients were recruited during control periods (control group), and 284 patients were recruited during interventions periods (intervention group). Only the intervention group had a significant increase in EQ-5D-5L utility scores from baseline to 12 months follow-up (mean change 0.03; 95% CI 0.01, 0.05) with QALYs gained: 0.02 (95% CI -0.08, 0.12). The structured OA model cost approx. €301 p.p. with an additional €50 for the Healthy Eating Program. Total 12 months healthcare cost p.p. was €1281 in the intervention and €3147 in the control group, resulting in an incremental cost of -€1866 (95% CI -3147, -584) p.p. Costs related to surgical procedures had the largest impact on total healthcare costs in both groups. During the 12-months follow-up period, 5% (n=14) in the intervention compared to 12% (n=13) in the control group underwent joint surgery; resulting in a mean surgical procedure cost of €553 p.p. in the intervention as compared to €1624 p.p. in the control group. The ICER was -€93300, indicating that the OA care model resulted in QALYs gained and cost-savings. At a threshold of €27500, it is 99% likely that the OA care model is a cost-effective alternative.Conclusion:The results of the cost-utility analysis show that implementing a structured model for OA care in primary healthcare based on international guidelines is highly likely a cost-effective alternative compared to usual care for people with hip and knee OA. More studies are needed to confirm this finding, but this study results indicate that implementing structured OA care models in primary healthcare may be beneficial for the individual as well as for the society.Disclosure of Interests:None declared

scholarly journals Economic evaluation of robot-assisted radical prostatectomy compared to open radical prostatectomy for prostate cancer treatment in Ontario, Canada

2020 ◽  
Vol 14 (8) ◽  
Author(s):  
Anna Parackal ◽  
Jean-Eric Tarride ◽  
Feng Xie ◽  
Gord Blackhouse ◽  
Jennifer Hoogenes ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Radical Prostatectomy ◽  
Time Horizon ◽  
Cost Effective ◽  
Cost Utility ◽  
Economic Evaluations ◽  
Base Case ◽  
Robot Assisted ◽  
Open Radical Prostatectomy ◽  
Life Years

Introduction: Recent health technology assessments (HTAs) of robot-assisted radical prostatectomy (RARP) in Ontario and Alberta, Canada, resulted in opposite recommendations, calling into question whether benefits of RARP offset the upfront investment. Therefore, the study objectives were to conduct a cost-utility analysis from a Canadian public payer perspective to determine the cost-effectiveness of RARP. Methods: Using a 10-year time horizon, a five-state Markov model was developed to compare RARP to open radical prostatectomy (ORP). Clinical parameters were derived from Canadian observational studies and a recently published systematic review. Costs, resource utilization, and utility values from recent Canadian sources were used to populate the model. Results were presented in terms of increment costs per quality-adjusted life years (QALYs) gained. A probabilistic analysis was conducted, and uncertainty was represented using cost-effectiveness acceptability curves (CEACs). One-way sensitivity analyses were also conducted. Future costs and QALYs were discounted at 1.5%. Results: Total cost of RARP and ORP were $47 033 and $45 332, respectively. Total estimated QALYs were 7.2047 and 7.1385 for RARP and ORP, respectively. The estimated incremental cost-utility ratio (ICUR) was $25 704 in the base-case analysis. At a willingness-to-pay threshold of $50 000 and $100 000 per QALY gained, the probability of RARP being cost-effective was 0.65 and 0.85, respectively. The model was most sensitive to the time horizon. Conclusions: The results of this analysis suggest that RARP is likely to be cost-effective in this Canadian patient population. The results are consistent with Alberta’s HTA recommendation and other economic evaluations, but challenges Ontario’s reimbursement decision.

Ixazomib (IXA), carfilzomib (CAR), elotuzumab (ELO) or daratumumab (DAR) with lenalidomide and dexamethasone (LEN+DEX) versus LEN+DEX only in relapsed/refractory multiple myeloma (R/R MM): A comparative cost-effectiveness analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8043-8043
Author(s):  
Mavis Obeng-Kusi ◽  
Daniel Arku ◽  
Neda Alrawashdh ◽  
Briana Choi ◽  
Nimer S. Alkhatib ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Cost Effective ◽  
Cost Utility ◽  
Cost Effectiveness Analysis ◽  
The Other ◽  
Sensitivity Analyses ◽  
Treatment Comparison ◽  
Comparative Cost ◽  
Effectiveness Analysis ◽  
Life Years

8043 Background: IXA, CAR, ELO and DARin combination with LEN+DEXhave been found superior in efficacy compared to LEN+DEX in the management of R/R MM. Applying indirect treatment comparisons from a network meta-analysis (NMA), this economic evaluation aimed to estimate the comparative cost-effectiveness and cost-utility of these four triplet regimens in terms of progression-free survival (PFS). Methods: In the absence of direct treatment comparison from a single clinical trial, NMA was used to indirectly estimate the comparative PFS benefit of each regimen. A 2-state Markov model simulating the health outcomes and costs was used to evaluate PFS life years (LY) and quality-adjusted life years (QALY) with the triplet regimens over LEN+DEX and expressed as the incremental cost-effectiveness (ICER) and cost-utility ratios (ICUR). Probability sensitivity analyses were conducted to assess the influence of parameter uncertainty on the model. Results: The NMA revealed that DAR+LEN+DEX was superior to the other triplet therapies, which did not differ statistically amongst them. As detailed in the Table, in our cost-effectiveness analysis, all 4 triplet regimens were associated with increased PFSLY and PFSQALY gained (g) over LEN+DEX at an additional cost. DAR+LEN+DEX emerged the most cost-effective with ICER and ICUR of $667,652/PFSLYg and $813,322/PFSQALYg, respectively. The highest probability of cost-effectiveness occurred at a willingness-to-pay threshold of $1,040,000/QALYg. Conclusions: Our economic analysis shows that all the triplet regimens were more expensive than LEN +DEX only but were also more effective with respect to PFSLY and PFSQALY gained. Relative to the other regimens, the daratumumab regimen was the most cost-effective.[Table: see text]

scholarly journals A one-year cost–utility analysis of REBOA versus RTACC for non-compressible torso haemorrhage

Trauma ◽  
2017 ◽  
Vol 21 (1) ◽  
pp. 45-54 ◽  
Author(s):  
Maxwell S Renna ◽  
Cristiano van Zeller ◽  
Farah Abu-Hijleh ◽  
Cherlyn Tong ◽  
Jasmine Gambini ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Cost Effective ◽  
Quality Adjusted Life Year ◽  
Cost Utility ◽  
Incremental Cost Effectiveness Ratio ◽  
Cost Utility Analysis ◽  
Utility Analysis ◽  
Cost Effectiveness Ratio ◽  
One Year ◽  
Quality Adjusted Life

Introduction Major trauma is a leading cause of death and disability in young adults, especially from massive non-compressible torso haemorrhage. The standard technique to control distal haemorrhage and maximise central perfusion is resuscitative thoracotomy with aortic cross-clamping (RTACC). More recently, the minimally invasive technique of resuscitative endovascular balloon occlusion of the aorta (REBOA) has been developed to similarly limit distal haemorrhage without the morbidity of thoracotomy; cost–utility studies on this intervention, however, are still lacking. The aim of this study was to perform a one-year cost–utility analysis of REBOA as an intervention for patients with major traumatic non-compressible abdominal haemorrhage, compared to RTACC within the U.K.’s National Health Service. Methods A retrospective analysis of the outcomes following REBOA and RTACC was conducted based on the published literature of survival and complication rates after intervention. Utility was obtained from studies that used the EQ-5D index and from self-conducted surveys. Costs were calculated using 2016/2017 National Health Service tariff data and supplemented from further literature. A cost–utility analysis was then conducted. Results A total of 12 studies for REBOA and 20 studies for RTACC were included. The mean injury severity scores for RTACC and REBOA were 34 and 39, and mean probability of death was 9.7 and 54%, respectively. The incremental cost-effectiveness ratio of REBOA when compared to RTACC was £44,617.44 per quality-adjusted life year. The incremental cost-effectiveness ratio, by exceeding the National Institute for Health and Clinical Effectiveness’s willingness-to-pay threshold of £30,000/quality-adjusted life year, suggests that this intervention is not cost-effective in comparison to RTACC. However, REBOA yielded a 157% improvement in utility with a comparatively small cost increase of 31.5%. Conclusion Although REBOA has not been found to be cost-effective when compared to RTACC, ultimately, clinical experience and expertise should be the main factor in driving the decision over which intervention to prioritise in the emergency context.

Cost-effectiveness of assertive community treatment for homeless persons with severe mental illness

1999 ◽  
Vol 174 (4) ◽  
pp. 346-352 ◽  
Author(s):  
Anthony F. Lehman ◽  
Lisa Dixon ◽  
Jeffrey S. Hoch ◽  
Bruce Deforge ◽  
Eimer Kernan ◽  
...  
Keyword(s):  
Mental Health ◽  
Mental Illness ◽  
Cost Effectiveness ◽  
Severe Mental Illness ◽  
Usual Care ◽  
Assertive Community Treatment ◽  
Cost Effective ◽  
Homeless Persons ◽  
Community Treatment ◽  
Stable Housing

BackgroundHomelessness is a major public health problem among persons with severe mental illness (SMI). Cost-effective programmes that address this problem are needed.AimsTo evaluate the cost-effectiveness of an assertive community treatment (ACT) programme for these persons in Baltimore, Maryland.MethodsA total of 152 homeless persons with SMI were randomly allocated to either ACT or usual services. Direct treatment costs and effectiveness, represented by days of stable housing, were assessed.ResultsCompared with usual care, ACT costs were significantly lower for mental health in-patient days and mental health emergency room care, and significantly higher for mental health out-patient visits and treatment for substance misuse. ACT patients spent 31% more days in stable housing than those receiving usual care. ACT and usual services incurred $242 and $415 respectively in direct treatment costs per day of stable housing, an efficiency ratio of 0. 58 in favour of ACT. Patterns of care and costs varied according to race.ConclusionACT provides a cost-effective approach to reducing homelessness among persons with severe and persistent mental illnesses.

scholarly journals Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people: a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial)

2017 ◽  
Vol 21 (24) ◽  
pp. 1-198 ◽  
Author(s):  
Sarah Cockayne ◽  
Sara Rodgers ◽  
Lorraine Green ◽  
Caroline Fairhurst ◽  
Joy Adamson ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Incidence Rate ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Clinical Effectiveness ◽  
Cost Effective ◽  
Falls Prevention ◽  
Randomised Controlled

BackgroundFalls are a serious cause of morbidity and cost to individuals and society. Evidence suggests that foot problems and inappropriate footwear may increase the risk of falling. Podiatric interventions could help reduce falls; however, there is limited evidence regarding their clinical effectiveness and cost-effectiveness.ObjectivesTo determine the clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community-dwelling older people at risk of falling, relative to usual care.DesignA pragmatic, multicentred, cohort randomised controlled trial with an economic evaluation and qualitative study.SettingNine NHS trusts in the UK and one site in Ireland.ParticipantsIn total, 1010 participants aged ≥ 65 years were randomised (intervention,n = 493; usual care,n = 517) via a secure, remote service. Blinding was not possible.InterventionsAll participants received a falls prevention leaflet and routine care from their podiatrist and general practitioner. The intervention also consisted of footwear advice, footwear provision if required, foot orthoses and foot- and ankle-strengthening exercises.Main outcome measuresThe primary outcome was the incidence rate of falls per participant in the 12 months following randomisation. The secondary outcomes included the proportion of fallers and multiple fallers, time to first fall, fear of falling, fracture rate, health-related quality of life (HRQoL) and cost-effectiveness.ResultsThe primary analysis consisted of 484 (98.2%) intervention and 507 (98.1%) usual-care participants. There was a non-statistically significant reduction in the incidence rate of falls in the intervention group [adjusted incidence rate ratio 0.88, 95% confidence interval (CI) 0.73 to 1.05;p = 0.16]. The proportion of participants experiencing a fall was lower (50% vs. 55%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00;p = 0.05). No differences were observed in key secondary outcomes. No serious, unexpected and related adverse events were reported. The intervention costs £252.17 more per participant (95% CI –£69.48 to £589.38) than usual care, was marginally more beneficial in terms of HRQoL measured via the EuroQoL-5 Dimensions [mean quality-adjusted life-year (QALY) difference 0.0129, 95% CI –0.0050 to 0.0314 QALYs] and had a 65% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £30,000 per QALY gained. The intervention was generally acceptable to podiatrists and trial participants.LimitationsOwing to the difficulty in calculating a sample size for a count outcome, the sample size was based on detecting a difference in the proportion of participants experiencing at least one fall, and not the primary outcome. We are therefore unable to confirm if the trial was sufficiently powered for the primary outcome. The findings are not generalisable to patients who are not receiving podiatry care.ConclusionsThe intervention was safe and potentially effective. Although the primary outcome measure did not reach significance, a lower fall rate was observed in the intervention group. The reduction in the proportion of older adults who experienced a fall was of borderline statistical significance. The economic evaluation suggests that the intervention could be cost-effective.Future workFurther research could examine whether or not the intervention could be delivered in group sessions, by physiotherapists, or in high-risk patients.Trial registrationCurrent Controlled Trials ISRCTN68240461.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 24. See the NIHR Journals Library website for further project information.

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