Protocol for the THREAD (THREshold for AntiDepressants) study: a randomised controlled trial to determine the clinical and cost-effectiveness of antidepressants plus supportive care, versus supportive care alone, for mild to moderate depression in UK general practice

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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The cost-effectiveness of point of care testing in a general practice setting: results from a randomised controlled trial

BMC Health Services Research ◽

10.1186/1472-6963-10-165 ◽

2010 ◽

Vol 10 (1) ◽

Cited By ~ 33

Author(s):

Caroline O Laurence ◽

◽

John R Moss ◽

Nancy E Briggs ◽

Justin J Beilby

Keyword(s):

General Practice ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Point Of Care ◽

Controlled Trial ◽

Practice Setting ◽

Point Of Care Testing ◽

General Practice Setting ◽

Randomised Controlled ◽

The Cost

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Effectiveness and cost-effectiveness of telephone consultations for fever or gastroenteritis using a formalised procedure in general practice: study protocol of a cluster randomised controlled trial

Trials ◽

10.1186/s13063-016-1585-9 ◽

2016 ◽

Vol 17 (1) ◽

Cited By ~ 1

Author(s):

Paul-Georges Reuter ◽

Thibaut Desmettre ◽

Sabine Guinemer ◽

Olivier Ducros ◽

Stéphane Begey ◽

...

Keyword(s):

General Practice ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Study Protocol ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Cluster Randomised ◽

Practice Study ◽

Randomised Controlled

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Randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of selective serotonin reuptake inhibitors plus supportive care, versus supportive care alone, for mild to moderate depression with somatic symptoms in primary care: the THREAD (THREshold for AntiDepressant response) study

Health Technology Assessment ◽

10.3310/hta13220 ◽

2009 ◽

Vol 13 (22) ◽

Cited By ~ 48

Author(s):

T Kendrick ◽

J Chatwin ◽

C Dowrick ◽

A Tylee ◽

R Morriss ◽

...

Keyword(s):

Primary Care ◽

Cost Effectiveness ◽

Supportive Care ◽

Selective Serotonin Reuptake Inhibitors ◽

Controlled Trial ◽

Somatic Symptoms ◽

Clinical Effectiveness ◽

Antidepressant Response ◽

Moderate Depression ◽

Randomised Controlled

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Effectiveness and cost-effectiveness of a proactive, goal-oriented, integrated care model in general practice for older people. A cluster randomised controlled trial: Integrated Systematic Care for older People—the ISCOPE study

Age and Ageing ◽

10.1093/ageing/afv174 ◽

2016 ◽

Vol 45 (1) ◽

pp. 30-41 ◽

Cited By ~ 55

Author(s):

Jeanet Blom ◽

Wendy den Elzen ◽

Anne H. van Houwelingen ◽

Margot Heijmans ◽

Theo Stijnen ◽

...

Keyword(s):

General Practice ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Older People ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Care Model ◽

Cluster Randomised ◽

Randomised Controlled ◽

Care For Older People

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Randomised controlled trial and cost-effectiveness evaluation of an interactive video system to promote shared decision making in general practice

http://isrctn.org/> ◽

10.1186/isrctn37846533 ◽

2012 ◽

Author(s):

Elizabeth Murray

Keyword(s):

Decision Making ◽

General Practice ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Shared Decision Making ◽

Interactive Video ◽

Controlled Trial ◽

Effectiveness Evaluation ◽

Shared Decision ◽

Randomised Controlled

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A randomised controlled trial to determine the cost-effectiveness of fluoxetine for mild to moderate depression with somatic symptoms in primary care

http://isrctn.org/> ◽

10.1186/isrctn84854789 ◽

2012 ◽

Author(s):

Anthony Kendrick

Keyword(s):

Primary Care ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Somatic Symptoms ◽

Moderate Depression ◽

Randomised Controlled ◽

The Cost

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The effectiveness and cost-effectiveness of telephone triage of patients requesting same day consultations in general practice: study protocol for a cluster randomised controlled trial comparing nurse-led and GP-led management systems (ESTEEM)

Trials ◽

10.1186/1745-6215-14-4 ◽

2013 ◽

Vol 14 (1) ◽

pp. 4 ◽

Cited By ~ 11

Author(s):

John L Campbell ◽

Nicky Britten ◽

Colin Green ◽

Tim A Holt ◽

Valerie Lattimer ◽

...

Keyword(s):

General Practice ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Study Protocol ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Management Systems ◽

Telephone Triage ◽

Cluster Randomised ◽

Randomised Controlled

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Cost-effectiveness of a care manager collaborative care programme for patients with depression in primary care: 12-month economic evaluation of a pragmatic randomised controlled trial

Cost Effectiveness and Resource Allocation ◽

10.1186/s12962-021-00304-5 ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Anna Holst ◽

Frida Labori ◽

Cecilia Björkelund ◽

Dominique Hange ◽

Irene Svenningsson ◽

...

Keyword(s):

Primary Care ◽

Health Care ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Societal Perspective ◽

Controlled Trial ◽

Health Benefits ◽

Care Manager ◽

Moderate Depression ◽

Randomised Controlled

Abstract Objectives To study the cost-effectiveness of a care manager organization for patients with mild to moderate depression in Swedish primary care in a 12-month perspective. Methods Cost-effectiveness analysis of the care manager organization compared to care as usual (CAU) in a pragmatic cluster randomised controlled trial including 192 individuals in the care manager group and 184 in the CAU group. Cost-effectiveness was assessed from a health care and societal perspectives. Costs were assessed in relation to two different health outcome measures: depression free days (DFDs) and quality adjusted life years (QALYs). Results At the 12-month follow-up, patients treated at the intervention Primary Care Centres (PCCs) with a care manager organization had larger health benefits than the group receiving usual care only at control PCCs. Mean QALY per patient was 0.73 (95% CI 0.7; 0.75) in the care manager group compared to 0.70 (95% CI 0.66; 0.73) in the CAU group. Mean DFDs was 203 (95% CI 178; 229) in the care manager group and 155 (95% CI 131; 179) in the CAU group. Further, from a societal perspective, care manager care was associated with a lower cost than care as usual, resulting in a dominant incremental cost-effectiveness ratio (ICER) for both QALYs and DFDs. From a health care perspective care manager care was related to a low cost per QALY (36,500 SEK / €3,379) and DFD (31 SEK/€3). Limitations A limitation is the fact that QALY data was impaired by insufficient EQ-5D data for some patients. Conclusions A care manager organization at the PCC to increase quality of care for patients with mild-moderate depression shows high health benefits, with no decay over time, and high cost-effectiveness both from a health care and a societal perspective. Trial registration details: The trial was registered in ClinicalTrials.com (https://clinicaltrials.gov/ct2/show/NCT02378272) in 02/02/2015 with the registration number NCT02378272. The first patient was enrolled in 11/20/2014.

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