A pragmatic single-blind randomised controlled trial and health economic evaluation of leukotriene receptor antagonists in primary care at steps two and three of the national asthma guidelines

2012 ◽  
Author(s):  
David Price
Keyword(s):  
Primary Care ◽  
Health Economic ◽  
Economic Evaluation ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Health Economic Evaluation ◽  
Receptor Antagonists ◽  
Leukotriene Receptor ◽  
Randomised Controlled ◽  
Single Blind

scholarly journals A supported self-help for recurrent depression in primary care; An economic evaluation alongside a multi-center randomised controlled trial

PLoS ONE ◽  
2018 ◽  
Vol 13 (12) ◽  
pp. e0208570 ◽  
Author(s):  
Karolien E. M. Biesheuvel-Leliefeld ◽  
Judith E. Bosmans ◽  
Sandra M. A. Dijkstra-Kersten ◽  
Filip Smit ◽  
Claudi L. H. Bockting ◽  
...  
Keyword(s):  
Primary Care ◽  
Economic Evaluation ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Recurrent Depression ◽  
Self Help ◽  
Randomised Controlled

scholarly journals Economic evaluation of the OSAC randomised controlled trial: oral corticosteroids for non-asthmatic adults with acute lower respiratory tract infection in primary care

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e033567
Author(s):  
Aida Moure-Fernandez ◽  
Sandra Hollinghurst ◽  
Fran E Carroll ◽  
Harriet Downing ◽  
Grace Young ◽  
...  
Keyword(s):  
Primary Care ◽  
Economic Evaluation ◽  
Randomised Controlled Trial ◽  
Lower Respiratory Tract ◽  
Controlled Trial ◽  
Quality Adjusted Life Years ◽  
Life Years ◽  
Oral Corticosteroids ◽  
Randomised Controlled ◽  
Quality Adjusted Life

ObjectiveTo estimate the costs and outcomes associated with treating non-asthmatic adults (nor suffering from other lung-disease) presenting to primary care with acute lower respiratory tract infection (ALRTI) with oral corticosteroids compared with placebo.DesignCost-consequence analysis alongside a randomised controlled trial. Perspectives included the healthcare provider, patients and productivity losses associated with time off work.SettingFifty-four National Health Service (NHS) general practices in England.Participants398 adults attending NHS primary practices with ALRTI but no asthma or other chronic lung disease, followed up for 28 days.Interventions2× 20 mg oral prednisolone per day for 5 days versus matching placebo tablets.Outcome measuresQuality-adjusted life years using the 5-level EuroQol-5D version measured weekly; duration and severity of symptom. Direct and indirect resources related to the disease and its treatment were also collected. Outcomes were measured for the 28-day follow-up.Results198 (50%) patients received the intervention (prednisolone) and 200 (50%) received placebo. NHS costs were dominated by primary care contacts, higher with placebo than with prednisolone (£13.11 vs £10.38) but without evidence of a difference (95% CI £3.05 to £8.52). The trial medication cost of £1.96 per patient would have been recouped in prescription charges of £4.30 per patient overall (55% participants would have paid £7.85), giving an overall mean ‘profit’ to the NHS of £7.00 (95% CI £0.50 to £17.08) per patient. There was a quality adjusted life years gain of 0.03 (95% CI 0.01 to 0.05) equating to half a day of perfect health favouring the prednisolone patients; there was no difference in duration of cough or severity of symptoms.ConclusionsThe use of prednisolone for non-asthmatic adults with ALRTI, provided small gains in quality of life and cost savings driven by prescription charges. Considering the results of the economic evaluation and possible side effects of corticosteroids, the short-term benefits may not outweigh the long-term harms.Trial registration numbersEudraCT 2012-000851-15 and ISRCTN57309858; Pre-results.

scholarly journals Efficacy and cost-effectiveness of therapist-guided internet-delivered behaviour therapy for children and adolescents with Tourette syndrome: study protocol for a single-blind randomised controlled trial

2021 ◽  
Author(s):  
Per Andrén ◽  
Lorena Fernández de la Cruz ◽  
Kayoko Isomura ◽  
Fabian Lenhard ◽  
Charlotte L Hall ◽  
...  
Keyword(s):  
Health Economic ◽  
Primary Endpoint ◽  
Controlled Trial ◽  
Health Economic Evaluation ◽  
Primary Objective ◽  
Behaviour Therapy ◽  
Tic Severity ◽  
Randomised Controlled ◽  
Single Blind

Background: Treatment guidelines recommend behaviour therapy (BT) for patients with Tourette syndrome (TS) and chronic tic disorder (CTD). However, BT is rarely accessible due to limited availability of trained therapists and long travel distances to specialist clinics. Internet-delivered BT has the potential of overcoming these barriers through remote delivery of treatment with minimal therapist support. In the current protocol, we outline the design and methods of a randomised controlled trial (RCT) evaluating an internet-delivered BT programme referred to as BIP TIC. The trial’s primary objective is to determine the clinical efficacy of BIP TIC for reducing tic severity in young people with TS/CTD, compared with an active control intervention. Secondary objectives are to investigate the 12-month durability of the treatment effects and to perform a health economic evaluation of the intervention.Methods: In this single-blind superiority RCT, 220 participants (9-17 years) with TS/CTD throughout Sweden will be randomised to 10-12 weeks of either therapist-supported internet-delivered BT based on exposure with response prevention (BIP TIC) or therapist-supported internet-delivered education. Data will be collected at baseline, 3 and 5 weeks into the treatment, at post-treatment, and 3, 6, and 12 months post-treatment. The primary endpoint is the 3-month follow-up. The primary outcome is tic severity as measured by the Yale Global Tic Severity Scale – Total tic severity score. Treatment response is operationalised as scores of “Very much improved” or “Much improved” on the Clinical Global Impression – Improvement scale, administered at the primary endpoint. Outcome assessors will be blind to treatment condition at all assessment points. A health economic evaluation of BIP TIC will be performed, both in the short term (primary endpoint) and the long term (12-month follow-up). There are no planned interim analyses. Discussion: Participant recruitment started on 26 April 2019 and finished on 9 April 2021. The final participant will reach the primary endpoint in September 2021 and the 12-month follow-up in June 2022. Data analysis for the primary objective will commence after the last participant reaches the primary endpoint.

scholarly journals Collection devices to reduce contamination in urine samples provided for diagnosis of uncomplicated urinary tract infection: a single blind randomised controlled trial

2021 ◽  
pp. BJGP.2021.0359
Author(s):  
Gail Hayward ◽  
Sam Mort ◽  
Ly-mee Yu ◽  
Merryn Voysey ◽  
Margaret Glogowska ◽  
...  
Keyword(s):  
Primary Care ◽  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Randomised Controlled Trial ◽  
Tract Infection ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Sample Collection ◽  
Randomised Controlled ◽  
Single Blind

Background: Urine collection devices (UCD) are being marketed and used in clinical settings to reduce urine sample contamination, despite inadequate supporting evidence. Aim: To determine whether UCDs, compared to standardised instructions for urine sample collection, reduce the proportion of contaminated samples. Design, Setting: Single blind randomised controlled trial in UK Primary care. Method: Women aged ≥ 18 years presenting to with symptoms attributable to urinary tract infection (UTI) were randomised (1:1:1) to use either a Peezy UCD, a Whizaway Midstream UCD, or standardised verbal instructions (SVI) for midstream sample collection. The primary outcome was the proportion of urine samples reported as contaminated by microbiology laboratory analysis. Results: 1264 women (Peezy n=424; Whizaway n=421; SVI n=419) were randomised between 5/10/16 and 20/8/18. 90 women were excluded from the primary analysis due to ineligibility or lack of primary outcome data, leaving 1174 (n=381; n=390; n=403) for intention-to-treat analysis. The proportion of contaminated samples was 26.5% with the Peezy, 28.2% Whizaway, and 29% SVI (relative risk (RR) Peezy v SVI 0.91 [95% Confidence Interval (CI) 0.76 to 1.09] (P = 0.32); Whizaway v SI 0.98 [95% CI 0.97 to 1.20] (P = 0.82)). There were 100 (25.3%) device failures with Peezy and 35 (8.8%) with Whizaway UCDs; the proportion of contaminated samples was similar after device failure samples were excluded. Conclusion: Neither Peezy nor Whizaway UCDs reduced sample contamination when used by women presenting to primary care with suspected UTI. Their use cannot be recommended for this purpose in this setting.

scholarly journals Efficacy and cost-effectiveness of therapist-guided internet-delivered behaviour therapy for children and adolescents with Tourette syndrome: study protocol for a single-blind randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Per Andrén ◽  
Lorena Fernández de la Cruz ◽  
Kayoko Isomura ◽  
Fabian Lenhard ◽  
Charlotte L. Hall ◽  
...  
Keyword(s):  
Health Economic ◽  
Primary Endpoint ◽  
Controlled Trial ◽  
Health Economic Evaluation ◽  
Primary Objective ◽  
Behaviour Therapy ◽  
Tic Severity ◽  
Randomised Controlled ◽  
Single Blind

Abstract Background Treatment guidelines recommend behaviour therapy (BT) for patients with Tourette syndrome (TS) and chronic tic disorder (CTD). However, BT is rarely accessible due to limited availability of trained therapists and long travel distances to specialist clinics. Internet-delivered BT has the potential of overcoming these barriers through remote delivery of treatment with minimal therapist support. In the current protocol, we outline the design and methods of a randomised controlled trial (RCT) evaluating an internet-delivered BT programme referred to as BIP TIC. The trial’s primary objective is to determine the clinical efficacy of BIP TIC for reducing tic severity in young people with TS/CTD, compared with an active control intervention. Secondary objectives are to investigate the 12-month durability of the treatment effects and to perform a health economic evaluation of the intervention. Methods In this single-blind superiority RCT, 220 participants (9–17 years) with TS/CTD throughout Sweden will be randomised to 10–12 weeks of either therapist-supported internet-delivered BT based on exposure with response prevention (BIP TIC) or therapist-supported internet-delivered education. Data will be collected at baseline, 3 and 5 weeks into the treatment, at post-treatment, and 3, 6, and 12 months post-treatment. The primary endpoint is the 3-month follow-up. The primary outcome is tic severity as measured by the Yale Global Tic Severity Scale – Total Tic Severity Score. Treatment response is operationalised as scores of “Very much improved” or “Much improved” on the Clinical Global Impression – Improvement scale, administered at the primary endpoint. Outcome assessors will be blind to treatment condition at all assessment points. A health economic evaluation of BIP TIC will be performed, both in the short term (primary endpoint) and the long term (12-month follow-up). There are no planned interim analyses. Discussion Participant recruitment started on 26 April 2019 and finished on 9 April 2021. The total number of included participants was 221. The final participant is expected to reach the primary endpoint in September 2021 and the 12-month follow-up in June 2022. Data analysis for the primary objective will commence after the last participant reaches the primary endpoint. Trial registration ClinicalTrials.gov NCT03916055. Registered on 16 April 2019.

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