scholarly journals The CHICO (Children's Cough) Trial protocol: a feasibility randomised controlled trial investigating the clinical and cost-effectiveness of a complex intervention to improve the management of children presenting to primary care with acute respiratory tract infection

BMJ Open ◽  
2015 ◽  
Vol 5 (9) ◽  
pp. e008615 ◽  
Author(s):  
Sophie L Turnbull ◽  
Niamh M Redmond ◽  
Patricia Lucas ◽  
Christie Cabral ◽  
Jenny Ingram ◽  
...  
Keyword(s):  
Primary Care ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Tract Infection ◽  
Respiratory Tract ◽  
Controlled Trial ◽  
Acute Respiratory Tract Infection ◽  
Trial Protocol ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

scholarly journals Oral prednisolone for acute lower respiratory tract infection in clinically unrecognised asthma: an exploratory analysis of the Oral Steroids for Acute Cough (OSAC) randomised controlled trial

BJGP Open ◽  
2020 ◽  
Vol 4 (5) ◽  
pp. bjgpopen20X101099
Author(s):  
Sean Hawkey ◽  
Grace J Young ◽  
Paul Little ◽  
Michael Moore ◽  
Alastair D Hay
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Tract Infection ◽  
Respiratory Tract ◽  
Symptom Severity ◽  
Lower Respiratory Tract ◽  
Controlled Trial ◽  
Acute Cough ◽  
Oral Steroids ◽  
Randomised Controlled

BackgroundAcute lower respiratory tract infection (ALRTI) is often treated in primary care with antibiotics. The recent Oral Steroids for Acute Cough (OSAC) randomised controlled trial (RCT) showed corticosteroids were not an effective alternative in adults without a diagnosis of asthma with ALRTI.AimTo investigate if corticosteroids are beneficial for ALRTI in patients with unrecognised asthma.Design & settingAn exploratory analysis was undertaken of the primary care OSAC trial.MethodA subgroup analysis was performed in patients who responded ‘yes’ to the following International Primary Care Airways Group (IPCAG) question: did you have wheeze and/or at least two of nocturnal cough or chest tightness or dyspnoea in the past year. Sensitivity analyses were carried out on those who answered ‘yes’ to wheeze and at least two of the nocturnal symptoms. The primary outcomes were as follows: duration of cough (0–28 days, minimum clinically important difference [MCID] of 3.79 days) and mean symptom severity score (range 0–6; MCID 1.66 units).ResultsIn total, 40 (10%) patients were included in the main analysis: mean age 49 years (standard deviation [SD] = 17.9), 52% male. Median cough duration was 3 days in both prednisolone (interquartile range [IQR] = 2–6 days) and placebo (IQR = 1–6 days) groups (adjusted hazard ratio [HR] = 1.10; 95% confidence interval [CI] = 0.47 to 2.54; P = 0.83), equating to 0.24 days longer in the prednisolone group (95% CI = 1.23 days shorter to 2.88 days longer). Mean symptom severity difference was –0.14 (95% CI = –0.78 to 0.49; P=0.65) comparing prednisolone with placebo. Similar findings were found in the sensitivity analysis.ConclusionNo evidence was found to support the use of corticosteroids for ALRTI in patients with clinically unrecognised asthma. Clinicians should not use the IPCAG questions to target oral corticosteroid treatment in patients with ALRTI.

scholarly journals Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Aisha Shafayat ◽  
Emese Csipke ◽  
Lucy Bradshaw ◽  
Georgina Charlesworth ◽  
Florence Day ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Rating Scale ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Mild Dementia ◽  
Link Type ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone. Methods/design PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at 3 and 6 month’s post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at 3 to 6 months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined. Discussion This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so, will provide data to inform the design and conduct of a future trial. Trial registration ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019.

Sign in / Sign up

Export Citation Format

Share Document