Strengthening And stretching for Rheumatoid Arthritis of the Hand (SARAH). A randomised controlled trial and economic evaluation

BackgroundThe effectiveness of exercise for improving hand and wrist function in people with rheumatoid arthritis (RA) is uncertain.ObjectivesThe study aims were (1) to estimate the clinical effectiveness and cost-effectiveness of adding an optimised exercise programme for hands and upper limbs to standard care for patients with RA; and (2) to qualitatively describe the experience of participants in the trial with a particular emphasis on acceptability of the intervention, exercise behaviours and reasons for adherence/non-adherence.DesignA pragmatic, multicentred, individually randomised controlled trial with an embedded qualitative study. Outcome assessors were blind to group assignment and independent of treatment delivery.SettingSeventeen NHS trusts in England comprising 21 rheumatology and therapy departments.ParticipantsAdults with RA who had pain and dysfunction of the hands and/or wrists and had been on stable medication for at least 3 months. Patients were excluded if they were under 18 years old, had undergone upper limb surgery/fracture in the last 6 months, were on a waiting list for upper limb surgery or were pregnant.InterventionsUsual care or usual care plus an individualised exercise programme. Usual care consisted of joint protection education, general exercise advice and functional splinting if required. The exercise programme consisted of six sessions of strengthening and stretching exercises with a hand therapist, daily home exercises and strategies to maximise adherence.Main outcome measuresThe primary outcome was the Michigan Hand Outcome Questionnaire (MHQ) overall hand function subscale score at 12 months. Secondary outcome measures included the full MHQ, pain, health-related quality of life (Short Form questionnaire-12 items), impairment (grip strength, dexterity and range of motion) and self-efficacy. European Quality of Life-5 Dimensions, medication and health-care use were collected for the health economics evaluation. Follow-up was at 4 and 12 months post randomisation. Analysis was performed on an intention-to-treat basis.ResultsWe randomised 490 patients (244 to usual care, 246 to exercise programme). Compliance with the treatments was very good (93% of usual care participants and 75% of exercise programme participants completed treatment). Outcomes were obtained for 89% of participants at 12 months (222 for usual care, 216 for exercise programme). There was a statistically significant difference in favour of the exercise programme for the primary outcome at 4 and 12 months [mean difference 4.6 points, 95% confidence interval (CI) 2.2 to 7.0 points; and mean difference 4.4 points, 95% CI 1.6 to 7.1 points, respectively]. There were no significant differences in pain scores or adverse events. The estimated difference in mean quality-adjusted life-years (QALYs) accrued over 12 months was 0.01 greater (95% CI –0.03 to 0.05) in the exercise programme group. Imputed analysis produced incremental cost-effectiveness ratio estimates of £17,941 (0.59 probability of cost-effectiveness at willingness-to-pay threshold of £30,000 per QALY). The qualitative study found the exercise programme to be acceptable and highlighted the importance of the therapist in enabling patients to establish a routine and incorporate the exercises into their lives.ConclusionsThe results of the Strengthening And stretching for Rheumatoid Arthritis of the Hand trial suggest that the addition of an exercise programme for RA hands/wrists to usual care is clinically effective and cost-effective when compared with usual care alone. No adverse effects were associated with the exercise programme. The economic analysis suggests that the intervention is likely to be cost-effective.Study registrationCurrent Controlled Trials ISRCTN 89936343.Funding detailsThis 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. 19, No. 19. See the NIHR Journals Library website for further project information. This report has been developed in association with the NIHR Collaboration for Leadership in Applied Health Research and Care Oxford and the NIHR Biomedical Research Unit Funding Scheme. This project benefited from facilities funded through Birmingham Science City Translational Medicine Clinical Research and Infrastructure Trials Platform, with support from Advantage West Midlands.

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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)

Health Technology Assessment ◽

10.3310/hta21240 ◽

2017 ◽

Vol 21 (24) ◽

pp. 1-198 ◽

Cited By ~ 9

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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A pragmatic randomised controlled trial of the effectiveness and cost-effectiveness of ‘PhysioDirect’ telephone assessment and advice services for physiotherapy

Health Technology Assessment ◽

10.3310/hta17020 ◽

2013 ◽

Vol 17 (2) ◽

pp. 1-157 ◽

Cited By ~ 33

Author(s):

C Salisbury ◽

NE Foster ◽

C Hopper ◽

A Bishop ◽

S Hollinghurst ◽

...

Keyword(s):

Cost Effectiveness ◽

Usual Care ◽

Primary Outcome ◽

Controlled Trial ◽

Cost Effective ◽

Initial Assessment ◽

Face To Face ◽

Randomised Controlled ◽

Pragmatic Randomised Controlled Trial

BackgroundAs a result of long delays for physiotherapy for musculoskeletal problems, several areas in the UK have introduced PhysioDirect services in which patients telephone a physiotherapist for initial assessment and treatment advice. However, there is no robust evidence about the effectiveness, cost-effectiveness or acceptability to patients of PhysioDirect.ObjectiveTo investigate whether or not PhysioDirect is equally as clinically effective as and more cost-effective than usual care for patients with musculoskeletal (MSK) problems in primary care.DesignPragmatic randomised controlled trial to assess equivalence, incorporating economic evaluation and nested qualitative research. Patients were randomised in 2 : 1 ratio to PhysioDirect or usual care using a remote automated allocation system at the level of the individual, stratifying by physiotherapy site and minimising by sex, age group and site of MSK problem. For the economic analysis, cost consequences included NHS and patient costs, and the cost of lost production. Cost-effectiveness analysis was carried out from the perspective of the NHS. Interviews were conducted with patients, physiotherapists and their managers.SettingFour community physiotherapy services in England.ParticipantsAdults referred by general practitioners or self-referred for physiotherapy for a MSK problem.InterventionsPatients allocated to PhysioDirect were invited to telephone a senior physiotherapist for initial assessment and advice using a computerised template, followed by face-to-face care when necessary. Patients allocated to usual care were put on to a waiting list for face-to-face care.Main outcome measuresPrimary outcome was the Short Form questionnaire-36 items, version 2 (SF- 36v2) Physical Component Score (PCS) at 6 months after randomisation. Secondary outcomes included other measures of health outcome [Measure Yourself Medical Outcomes Profile, European Quality of Life-5 Dimensions (EuroQol health utility measure, EQ-5D), global improvement, response to treatment], wait for treatment, time lost from work and usual activities, patient satisfaction. Data were collected by postal questionnaires at baseline, 6 weeks and 6 months, and from routine records by researchers blind to allocation.ResultsA total of 1506 patients were allocated to PhysioDirect and 743 to usual care. Patients allocated to PhysioDirect had a shorter wait for treatment than those allocated to usual care [median 7 days vs 34 days; arm–time ratio 0.32, 95% confidence interval (CI) 0.29 to 0.35] and had fewer non-attended face-to-face appointments [incidence rate ratio 0.55 (95% CI 0.41 to 0.73)]. The primary outcome at 6 months' follow-up was equivalent between PhysioDirect and usual care [mean PCS 43.50 vs 44.18, adjusted difference in means −0.01 (95% CI −0.80 to 0.79)]. The secondary measures of health outcome all demonstrated equivalence at 6 months, with slightly greater improvement in the PhysioDirect arm at 6 weeks' follow-up. Patients were equally satisfied with access to care but slightly less satisfied overall with PhysioDirect compared with usual care. NHS costs (physiotherapy plus other relevant NHS costs) per patient were similar in the two arms [PhysioDirect £198.98 vs usual care £179.68, difference in means £19.30 (95% CI −£37.60 to £76.19)], while QALYs gained were also similar [difference in means 0.007 (95% CI −0.003 to 0.016)]. Incremental cost per QALY gained was £2889. The probability that PhysioDirect was cost-effective at a £20,000 willingness-to-pay threshold was 88%. These conclusions about cost-effectiveness were robust to sensitivity analyses. There was no evidence of difference between trial arms in cost to patients or value of lost production. No adverse events were detected.ConclusionsProviding physiotherapy via PhysioDirect is equally clinically effective compared with usual waiting list-based care, provides faster access to treatment, appears to be safe, and is broadly acceptable to patients. PhysioDirect is probably cost-effective compared with usual care.Trial registrationCurrent Controlled Trials ISRCTN55666618.FundingThis project was funded by the MRC and was managed by the NIHR (project number 09-800-12) on behalf of the MRC–NIHR partnership and will be published in full inHealth Technology Assessment; Vol. 17, No. 2. See the HTA programme website for further project information.

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Cost-effectiveness analysis of acupuncture compared with usual care for acute non-specific low back pain: secondary analysis of a randomised controlled trial

Acupuncture in Medicine ◽

10.1177/09645284211055747 ◽

2021 ◽

pp. 096452842110557

Author(s):

Trygve Skonnord ◽

Arne Fetveit ◽

Holgeir Skjeie ◽

Mette Brekke ◽

Margreth Grotle ◽

...

Keyword(s):

Health Care ◽

Cost Effectiveness ◽

Usual Care ◽

Controlled Trial ◽

Secondary Analysis ◽

Cost Effective ◽

Cost Effectiveness Analysis ◽

Effectiveness Analysis ◽

Randomised Controlled ◽

Care Costs

Objective: To assess the cost-effectiveness of a single treatment session of acupuncture, when applied in addition to usual care for acute low back pain (ALBP). Methods: Secondary analysis of a multicentre randomised controlled trial in Norwegian general practice. In total, 171 participants with ALBP ⩽14 days were randomised to a control group (CG) receiving usual care or to an acupuncture group (AG) receiving one additional session of Western medical acupuncture alongside usual care. Primary outcome measures for this cost-effectiveness analysis were quality-adjusted life years (QALYs), health care costs and societal costs at days 28 and 365, the incremental cost-effectiveness ratio (ICER) and net monetary benefit (NMB). The NMB was calculated on the basis of the Norwegian cost-effectiveness threshold of NOK 275,000 (USD 35,628) per QALY gained. Missing data were replaced by multiple chained imputation. Results: Eighty-six participants in the CG and 81 in the AG were included in the analysis. We found no QALY gain at day 28. At day 365, the incremental QALY of 0.035 was statistically significant. The differences in health care costs and societal costs were not statistically significant. Three out of four calculations led to negative ICERs (cost saving) and positive NMBs. For the health care perspective at day 365, the ICER was USD –568 per QALY and the NMB was USD 1265, with 95.9% probability of acupuncture being cost-effective. Conclusion: To our knowledge, this is the first cost-effectiveness analysis of acupuncture for ALBP. The findings indicate that acupuncture may be cost-effective from a 1-year perspective, but more studies are needed. Trial registration number: NCT01439412 (ClinicalTrials.gov).

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Cost-effectiveness of habit-based advice for weight control versus usual care in general practice in the Ten Top Tips (10TT) trial: economic evaluation based on a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2017-017511 ◽

2018 ◽

Vol 8 (8) ◽

pp. e017511 ◽

Cited By ~ 1

Author(s):

Nishma Patel ◽

Rebecca J Beeken ◽

Baptiste Leurent ◽

Rumana Z Omar ◽

Irwin Nazareth ◽

...

Keyword(s):

General Practice ◽

Economic Evaluation ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Health Service ◽

Usual Care ◽

Controlled Trial ◽

Cost Effective ◽

The Mean ◽

Randomised Controlled

ObjectiveTen Top Tips (10TT) is a primary care-led behavioural intervention which aims to help adults reduce and manage their weight by following 10 weight loss tips. The intervention promotes habit formation to encourage long-term behavioural changes. The aim of this study was to estimate the cost-effectiveness of 10TT in general practice from the perspective of the UK National Health Service.DesignAn economic evaluation was conducted alongside an individually randomised controlled trial.Setting14 general practitioner practices in England.ParticipantsAll patients were aged ≥18 years, with body mass index ≥30 kg/m2. A total of 537 patients were recruited; 270 received the usual care offered by their practices and 267 received the 10TT intervention.Outcomes measuresHealth service use and quality-adjusted life years (QALYs) were measured over 2 years. Analysis was conducted in terms of incremental net monetary benefits (NMBs), using non-parametric bootstrapping and multiple imputation.ResultsOver a 2-year time horizon, the mean costs and QALYs per patient in the 10TT group were £1889 (95% CI £1522 to £2566) and 1.51 (95% CI 1.44 to 1.58). The mean costs and QALYs for usual care were £1925 (95% CI £1599 to £2251) and 1.51 (95% CI 1.45 to 1.57), respectively. This generated a mean cost difference of −£36 (95% CI −£512 to £441) and a mean QALY difference of 0.001 (95% CI −0.080 to 0.082). The incremental NMB for 10TT versus usual care was £49 (95% CI −£1709 to £1800) at a maximum willingness to pay for a QALY of £20 000. 10TT had a 52% probability of being cost-effective at this threshold.ConclusionsCosts and QALYs for 10TT were not significantly different from usual care and therefore 10TT is as cost-effective as usual care. There was no evidence to recommend nor advice against offering 10TT to obese patients in general practices based on cost-effectiveness considerations.Trial registration numberISRCTN16347068; Post-results.

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Effectiveness and cost-effectiveness of a structured social coaching intervention for people with psychosis (SCENE): protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2021-050627 ◽

2021 ◽

Vol 11 (12) ◽

pp. e050627

Author(s):

Domenico Giacco ◽

Agnes Chevalier ◽

Megan Patterson ◽

Thomas Hamborg ◽

Rianna Mortimer ◽

...

Keyword(s):

Quality Of Life ◽

Cost Effectiveness ◽

Primary Outcome ◽

Controlled Trial ◽

Control Group ◽

Social Activities ◽

Social Contacts ◽

Coaching Intervention ◽

Randomised Controlled

IntroductionPeople with psychosis tend to have smaller social networks than both people in the general population and other people with long-term health conditions. Small social networks are associated with poor quality of life. Preliminary evidence suggests that coaching patients to increase their social contacts may be effective. In this study, we assessed whether structured social coaching improves the quality of life of patients with psychosis (primary outcome) compared with an active control group, receiving information on local social activities.Methods and analysisA structured social coaching intervention was developed based on the literature and refined through stakeholder involvement. It draws on principles from motivational interviewing, solution focused therapy and structured information giving. It is provided over a 6-month period and can be delivered by a range of different mental health professionals. Its effectiveness and cost-effectiveness are assessed in a randomised controlled trial, compared with an active control group, in which participants are given an information booklet on local social activities. Participants are aged 18 or over, have a primary diagnosis of a psychotic disorder (International Classification of Disease: F20–29) and capacity to provide informed consent. Participants are assessed at baseline and at 6, 12 and 18 months after individual randomisation. The primary outcome is quality of life at 6 months (Manchester Short Assessment of Quality of Life). We hypothesise that the effects on quality of life are mediated by an increase in social contacts. Secondary outcomes are symptoms, social situation and time spent in social activities. Costs and cost-effectiveness analyses will consider service use and health-related quality of life.Ethics and disseminationNational Health Service REC London Hampstead (19/LO/0088) provided a favourable opinion. Findings will be disseminated through a website, social media, scientific papers and user-friendly reports, in collaboration with a lived experience advisory panel.Trial registration numberISRCTN15815862.

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Economic evaluation of robot-assisted training versus an enhanced upper limb therapy programme or usual care for patients with moderate or severe upper limb functional limitation due to stroke: results from the RATULS randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-042081 ◽

2021 ◽

Vol 11 (5) ◽

pp. e042081

Author(s):

Cristina Fernandez-Garcia ◽

Laura Ternent ◽

Tara Marie Homer ◽

Helen Rodgers ◽

Helen Bosomworth ◽

...

Keyword(s):

Economic Evaluation ◽

Cost Effectiveness ◽

Usual Care ◽

Upper Limb ◽

Controlled Trial ◽

Functional Limitation ◽

Cost Effective ◽

Robot Assisted ◽

Randomised Controlled ◽

The Cost

ObjectiveTo determine whether robot-assisted training is cost-effective compared with an enhanced upper limb therapy (EULT) programme or usual care.DesignEconomic evaluation within a randomised controlled trial.SettingFour National Health Service (NHS) centres in the UK: Queen’s Hospital, Barking, Havering and Redbridge University Hospitals NHS Trust; Northwick Park Hospital, London Northwest Healthcare NHS Trust; Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde; and North Tyneside General Hospital, Northumbria Healthcare NHS Foundation Trust.Participants770 participants aged 18 years or older with moderate or severe upper limb functional limitation from first-ever stroke.InterventionsParticipants randomised to one of three programmes provided over a 12-week period: robot-assisted training plus usual care; the EULT programme plus usual care or usual care.Main economic outcome measuresMean healthcare resource use; costs to the NHS and personal social services in 2018 pounds; utility scores based on EQ-5D-5L responses and quality-adjusted life years (QALYs). Cost-effectiveness reported as incremental cost per QALY and cost-effectiveness acceptability curves.ResultsAt 6 months, on average usual care was the least costly option (£3785) followed by EULT (£4451) with robot-assisted training being the most costly (£5387). The mean difference in total costs between the usual care and robot-assisted training groups (£1601) was statistically significant (p<0.001). Mean QALYs were highest for the EULT group (0.23) but no evidence of a difference (p=0.995) was observed between the robot-assisted training (0.21) and usual care groups (0.21). The incremental cost per QALY at 6 months for participants randomised to EULT compared with usual care was £74 100. Cost-effectiveness acceptability curves showed that robot-assisted training was unlikely to be cost-effective and that EULT had a 19% chance of being cost-effective at the £20 000 willingness to pay (WTP) threshold. Usual care was most likely to be cost-effective at all the WTP values considered in the analysis.ConclusionsThe cost-effectiveness analysis suggested that neither robot-assisted training nor EULT, as delivered in this trial, were likely to be cost-effective at any of the cost per QALY thresholds considered.Trial registration numberISRCTN69371850.

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Randomised controlled trial evaluating the effectiveness and cost-effectiveness of ‘Families for Health’, a family-based childhood obesity treatment intervention delivered in a community setting for ages 6 to 11 years

Health Technology Assessment ◽

10.3310/hta21010 ◽

2017 ◽

Vol 21 (1) ◽

pp. 1-180 ◽

Cited By ~ 16

Author(s):

Wendy Robertson ◽

Joanna Fleming ◽

Atiya Kamal ◽

Thomas Hamborg ◽

Kamran A Khan ◽

...

Keyword(s):

Cost Effectiveness ◽

Usual Care ◽

Process Evaluation ◽

Outcome Measures ◽

Controlled Trial ◽

Cost Effective ◽

Z Score ◽

Clinically Significant ◽

Family Based ◽

Randomised Controlled

BackgroundEffective programmes to help children manage their weight are required. ‘Families for Health’ focuses on a parenting approach, designed to help parents develop their parenting skills to support lifestyle change within the family. Families for Health version 1 showed sustained reductions in mean body mass index (BMI) z-score after 2 years in a pilot project.ObjectiveThe aim was to evaluate its effectiveness and cost-effectiveness in a randomised controlled trial (RCT).DesignThe trial was a multicentre, investigator-blind RCT, with a parallel economic and process evaluation, with follow-up at 3 and 12 months. Randomisation was by family unit, using a 1 : 1 allocation by telephone registration, stratified by three sites, with a target of 120 families.SettingThree sites in the West Midlands, England, UK.ParticipantsChildren aged 6–11 years who were overweight (≥ 91st centile BMI) or obese (≥ 98th centile BMI), and their parents/carers. Recruitment was via referral or self-referral.InterventionsFamilies for Health version 2 is a 10-week, family-based community programme with parallel groups for parents and children, addressing parenting, lifestyle, social and emotional development. Usual care was the treatment for childhood obesity provided within each locality.Main outcome measuresJoint primary outcome measures were change in children’s BMI z-score and incremental cost per quality-adjusted life-year (QALY) gained at 12 months’ follow-up (QALYs were calculated using the European Quality of Life-5 Dimensions Youth version). Secondary outcome measures included changes in children’s waist circumference, percentage body fat, physical activity, fruit/vegetable consumption and quality of life. Parents’ BMI and mental well-being, family eating/activity, parent–child relationships and parenting style were also assessed. The process evaluation documented recruitment, reach, dose delivered, dose received and fidelity, using mixed methods.ResultsThe study recruited 115 families (128 children; 63 boys and 65 girls), with 56 families randomised to the Families for Health arm and 59 to the ‘usual-care’ control arm. There was 80% retention of families at 3 months (Families for Health, 46 families; usual care, 46 families) and 72% retention at 12 months (Families for Health, 44 families; usual care, 39 families). The change in BMI z-score at 12 months was not significantly different in the Families for Health arm and the usual-care arm [0.114, 95% confidence interval (CI) –0.001 to 0.229;p = 0.053]. However, within-group analysis showed that the BMI z-score was significantly reduced in the usual-care arm (–0.118, 95% CI –0.203 to –0.034;p = 0.007), but not in the Families for Health arm (–0.005, 95% CI –0.085 to 0.078;p = 0.907). There was only one significant difference between groups for secondary outcomes. The economic evaluation, taking a NHS and Personal Social Services perspective, showed that mean costs 12 months post randomisation were significantly higher for Families for Health than for usual care (£998 vs. £548;p < 0.001). The mean incremental cost-effectiveness of Families for Health was estimated at £552,175 per QALY gained. The probability that the Families for Health programme is cost-effective did not exceed 40% across a range of thresholds. The process evaluation demonstrated that the programme was implemented, as planned, to the intended population and any adjustments did not deviate widely from the handbook. Many families waited more than 3 months to receive the intervention. Facilitators’, parents’ and children’s experiences of Families for Health were largely positive and there were no adverse events. Further analysis could explore why some children show a clinically significant benefit while others have a worse outcome.ConclusionsFamilies for Health was neither effective nor cost-effective for the management of obesity in children aged 6–11 years, in comparison with usual care. Further exploration of the wide range of responses in BMI z-score in children following the Families for Health and usual-care interventions is warranted, focusing on children who had a clinically significant benefit and those who showed a worse outcome with treatment. Further research could focus on the role of parents in the prevention of obesity, rather than treatment.Trial registrationCurrent Controlled Trials ISRCTN45032201.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. 1. See the NIHR Journals Library website for further project information.

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Cost-effectiveness of telehealth for patients with depression: evidence from the Healthlines randomised controlled trial

BJPsych Open ◽

10.1192/bjpo.bp.116.002907 ◽

2016 ◽

Vol 2 (4) ◽

pp. 262-269 ◽

Cited By ~ 11

Author(s):

Padraig Dixon ◽

Sandra Hollinghurst ◽

Louisa Edwards ◽

Clare Thomas ◽

Alexis Foster ◽

...

Keyword(s):

Primary Care ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Cost Effective ◽

Monetary Benefit ◽

Randomised Controlled ◽

Net Monetary Benefit ◽

To Receive

BackgroundDepression is a prevalent long-term condition that is associated with substantial resource use. Telehealth may offer a cost-effective means of supporting the management of people with depression.AimsTo investigate the cost-effectiveness of a telehealth intervention (‘Healthlines’) for patients with depression.MethodA prospective patient-level economic evaluation conducted alongside a randomised controlled trial. Patients were recruited through primary care, and the intervention was delivered via a telehealth service. Participants with a confirmed diagnosis of depression and PHQ-9 score ≥10 were recruited from 43 English general practices. A series of up to 10 scripted, theory-led, telephone encounters with health information advisers supported participants to effect a behaviour change, use online resources, optimise medication and improve adherence. The intervention was delivered alongside usual care and was designed to support rather than duplicate primary care. Cost-effectiveness from a combined health and social care perspective was measured by net monetary benefit at the end of 12 months of follow-up, calculated from incremental cost and incremental quality-adjusted life years (QALYs). Cost–consequence analysis included cost of lost productivity, participant out-of-pocket expenditure and the clinical outcome.ResultsA total of 609 participants were randomised – 307 to receive the Healthlines intervention plus usual care and 302 to receive usual care alone. Forty-five per cent of participants had missing quality of life data, 41% had missing cost data and 51% of participants had missing data on either cost or utility, or both. Multiple imputation was used for the base-case analysis. The intervention was associated with incremental mean per-patient National Health Service/personal social services cost of £168 (95% CI £43 to £294) and an incremental QALY gain of 0.001 (95% CI −0.023 to 0.026). The incremental cost-effectiveness ratio was £132 630. Net monetary benefit at a cost-effectiveness threshold of £20 000 was –£143 (95% CI –£164 to –£122) and the probability of the intervention being cost-effective at this threshold value was 0.30. Productivity costs were higher in the intervention arm, but out-of-pocket expenses were lower.ConclusionsThe Healthlines service was acceptable to patients as a means of condition management, and response to treatment after 4 months was higher for participants randomised to the intervention. However, the positive average intervention effect size was modest, and incremental costs were high relative to a small incremental QALY gain at 12 months. The intervention is not likely to be cost-effective in its current form.

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The effectiveness and cost-effectiveness of mindfulness-based cognitive therapy compared with maintenance antidepressant treatment in the prevention of depressive relapse/recurrence: results of a randomised controlled trial (the PREVENT study)

Health Technology Assessment ◽

10.3310/hta19730 ◽

2015 ◽

Vol 19 (73) ◽

pp. 1-124 ◽

Cited By ~ 26

Author(s):

Willem Kuyken ◽

Rachel Hayes ◽

Barbara Barrett ◽

Richard Byng ◽

Tim Dalgleish ◽

...

Keyword(s):

Primary Outcome ◽

Controlled Trial ◽

Antidepressant Medication ◽

Cost Effective ◽

Recurrent Depression ◽

Primary Analysis ◽

History Of ◽

Randomised Controlled ◽

Time To Relapse

BackgroundIndividuals with a history of recurrent depression have a high risk of repeated depressive relapse/recurrence. Maintenance antidepressant medication (m-ADM) for at least 2 years is the current recommended treatment, but many individuals are interested in alternatives to m-ADM. Mindfulness-based cognitive therapy (MBCT) has been shown to reduce the risk of relapse/recurrence compared with usual care but has not yet been compared with m-ADM in a definitive trial.ObjectivesTo establish whether MBCT with support to taper and/or discontinue antidepressant medication (MBCT-TS) is superior to and more cost-effective than an approach of m-ADM in a primary care setting for patients with a history of recurrent depression followed up over a 2-year period in terms of preventing depressive relapse/recurrence. Secondary aims examined MBCT’s acceptability and mechanism of action.DesignSingle-blind, parallel, individual randomised controlled trial.SettingUK general practices.ParticipantsAdult patients with a diagnosis of recurrent depression and who were taking m-ADM.InterventionsParticipants were randomised to MBCT-TS or m-ADM with stratification by centre and symptomatic status. Outcome data were collected blind to treatment allocation and the primary analysis was based on the principle of intention to treat. Process studies using quantitative and qualitative methods examined MBCT’s acceptability and mechanism of action.Main outcomes measuresThe primary outcome measure was time to relapse/recurrence of depression. At each follow-up the following secondary outcomes were recorded: number of depression-free days, residual depressive symptoms, quality of life, health-related quality of life and psychiatric and medical comorbidities.ResultsIn total, 212 patients were randomised to MBCT-TS and 212 to m-ADM. The primary analysis did not find any evidence that MBCT-TS was superior to m-ADM in terms of the primary outcome of time to depressive relapse/recurrence over 24 months [hazard ratio (HR) 0.89, 95% confidence interval (CI) 0.67 to 1.18] or for any of the secondary outcomes. Cost-effectiveness analysis did not support the hypothesis that MBCT-TS is more cost-effective than m-ADM in terms of either relapse/recurrence or quality-adjusted life-years. In planned subgroup analyses, a significant interaction was found between treatment group and reported childhood abuse (HR 1.89, 95% CI 1.06 to 3.38), with delayed time to relapse/recurrence for MBCT-TS participants with a more abusive childhood compared with those with a less abusive history. Although changes in mindfulness were specific to MBCT (and not m-ADM), they did not predict outcome in terms of relapse/recurrence at 24 months. In terms of acceptability, the qualitative analyses suggest that many people have views about (dis)/continuing their ADM, which can serve as a facilitator or a barrier to taking part in a trial that requires either continuation for 2 years or discontinuation.ConclusionsThere is no support for the hypothesis that MBCT-TS is superior to m-ADM in preventing depressive relapse/recurrence among individuals at risk for depressive relapse/recurrence. Both treatments appear to confer protection against relapse/recurrence. There is an indication that MBCT may be most indicated for individuals at greatest risk of relapse/recurrence. It is important to characterise those most at risk and carefully establish if and why MBCT may be most indicated for this group.Trial registrationCurrent Controlled Trials ISRCTN26666654.FundingThis project was funded by the NIHR Health Technology Assessment programme and the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care South West Peninsula and will be published in full inHealth Technology Assessment; Vol. 19, No. 73. See the NIHR Journals Library website for further project information.

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Safety and Effects of Football in Skeletal Metastatic Prostate Cancer: a Subgroup Analysis of the FC Prostate Community Randomised Controlled Trial

Sports Medicine - Open ◽

10.1186/s40798-021-00318-6 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Eik Dybboe Bjerre ◽

Sarah Weller ◽

Mads Hvid Poulsen ◽

Søren Sørensen Madsen ◽

Rie Dybboe Bjerre ◽

...

Keyword(s):

Quality Of Life ◽

Prostate Cancer ◽

Usual Care ◽

Primary Outcome ◽

Hospital Admissions ◽

Controlled Trial ◽

Skeletal Metastases ◽

Randomised Controlled ◽

Football Training

Abstract Background Skeletal metastatic disease excludes many cancer patients from participating in exercise and physical activity due to safety concerns. Empirical evidence from high-quality trials is warranted to guide clinicians and patients. Objective To evaluate the safety and potential benefits of high-impact aerobic exercise in patients with prostate cancer with skeletal metastases. Design Exploratory subgroup analysis of a pragmatic, multicentre, parallel randomised controlled trial. Setting The trial recruited 214 patients from five hospital urological departments in Denmark. Participants Patients with prostate cancer with skeletal metastases (n = 41). Intervention Six months of football training twice weekly at a local club or usual care. Both groups received brief information on physical activity recommendations at the time of randomisation. Main Outcome(s) and Measure(s) Safety, defined as falls, fractures and hospital admissions. Effects were evaluated on the primary outcome (prostate cancer-specific quality of life) and secondary outcomes (lean body mass, fat mass, hip and spine bone mineral density, and general physical and mental health). Results The original trial comprised 214 participants, 41 of whom had skeletal metastases at enrolment. Of these, 22 were allocated to football and 19 to usual care. The trial retention rate was 95% at 12 weeks and 88% at 6 months. Football participants attended 13 sessions on average at 12 weeks and 23 at 6 months. There were two falls, one in each group after 6 months, and no fractures. There were four unplanned hospital admissions in the study period, all four in the usual care group. Statistically significant between-group difference was observed in the primary outcome change in prostate cancer-specific quality of life at 12 weeks (7.6 points [95% CI 0.5 to 15.0]; P = 0.038). No statistical changes were found in the secondary outcomes. Conclusion The analysis showed that football training was safe in patients with skeletal metastatic prostate cancer and significantly improved quality of life. Larger analyses and/or trials are warranted to confirm the safety of exercise more broadly in cancer patients with skeletal metastatic disease. Trial Registration ClinicalTrials.gov, NCT02430792. Date of registration 30 April 2015

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