TargetCOPD : a pragmatic randomised controlled trial of targeted case finding for COPD versus routine practice in primary care : protocol

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@article{6d3b41e659084e5d9c4537be7c931bf6,
title = "TargetCOPD : a pragmatic randomised controlled trial of targeted case finding for COPD versus routine practice in primary care : protocol",
abstract = "BackgroundMany people with clinically significant chronic obstructive pulmonary disease (COPD) remain undiagnosed worldwide. There are a number of small studies which have examined possible methods of case finding through primary care, but no large RCTs that have adequately assessed the most cost-effective approach.Methods/DesignIn this study, using a cluster randomised controlled trial (RCT) in 56 general practices in the West Midlands, we plan to investigate the effectiveness and cost-effectiveness of a Targeted approach to case finding for COPD compared with routine practice. Using an individual patient RCT nested in the Targeted arm, we plan also to compare the effectiveness and cost-effectiveness of Active case finding using a postal questionnaire (with supplementary opportunistic questionnaires), and Opportunistic-only case finding during routine surgery consultations.All ever-smoking patients aged 40-79 years, without a current diagnosis of COPD and registered with participating practices will be eligible. Patients in the Targeted arm who report positive respiratory symptoms (chronic cough or phlegm, wheeze or dyspnoea) using a brief questionnaire will be invited for further spirometric assessment to ascertain whether they have COPD or not. Post-bronchodilator spirometry will be conducted to ATS standards using an Easy One spirometer by trained research assistants.The primary outcomes will be new cases of COPD and cost per new case identified, comparing targeted case finding with routine care, and two types of targeted case finding (active versus opportunistic). A multilevel logistic regression model will be used to model the probability of detecting a new case of COPD for each treatment arm, with clustering of patients (by practice and household) accounted for using a multi-level structure.A trial-based analysis will be undertaken using costs and outcomes collected during the trial. Secondary outcomes include the feasibility, efficiency, long-term cost-effectiveness, patient and primary care staff views of each approach.DiscussionThis will be the largest RCT of its kind, and should inform how best to identify undiagnosed patients with COPD in the UK and other similar healthcare systems. Sensitivity analyses will help local policy-makers decide which sub-groups of the population to target first.",
keywords = "COPD, Case-finding, Screening, Primary care, Respiratory questionnaire, Spirometry, Cluster RCT, Cost-effectiveness",
author = "Rachel Jordan and Peyman{\'e} Adab and Sue Jowett and Jennifer Marsh and Riley, {Richard D} and Alexandra Enocson and Miller, {Martin R} and Cooper, {Brendan G} and Turner, {Alice M} and Jonathan Ayres and Kar Cheng and Catherine Jolly and Stockley, {Robert A} and Sheila Greenfield and William Siebert and Amanda Daley and Fitzmaurice, {David A}",
year = "2014",
month = oct,
day = "4",
doi = "10.1186/1471-2466-14-157",
language = "English",
volume = "14",
journal = "BMC Pulmonary Medicine",
issn = "1471-2466",
publisher = "Springer",
number = "1",

}

RIS

TY - JOUR

T1 - TargetCOPD : a pragmatic randomised controlled trial of targeted case finding for COPD versus routine practice in primary care : protocol

AU - Jordan, Rachel

AU - Adab, Peymané

AU - Jowett, Sue

AU - Marsh, Jennifer

AU - Riley, Richard D

AU - Enocson, Alexandra

AU - Miller, Martin R

AU - Cooper, Brendan G

AU - Turner, Alice M

AU - Ayres, Jonathan

AU - Cheng, Kar

AU - Jolly, Catherine

AU - Stockley, Robert A

AU - Greenfield, Sheila

AU - Siebert, William

AU - Daley, Amanda

AU - Fitzmaurice, David A

PY - 2014/10/4

Y1 - 2014/10/4

N2 - BackgroundMany people with clinically significant chronic obstructive pulmonary disease (COPD) remain undiagnosed worldwide. There are a number of small studies which have examined possible methods of case finding through primary care, but no large RCTs that have adequately assessed the most cost-effective approach.Methods/DesignIn this study, using a cluster randomised controlled trial (RCT) in 56 general practices in the West Midlands, we plan to investigate the effectiveness and cost-effectiveness of a Targeted approach to case finding for COPD compared with routine practice. Using an individual patient RCT nested in the Targeted arm, we plan also to compare the effectiveness and cost-effectiveness of Active case finding using a postal questionnaire (with supplementary opportunistic questionnaires), and Opportunistic-only case finding during routine surgery consultations.All ever-smoking patients aged 40-79 years, without a current diagnosis of COPD and registered with participating practices will be eligible. Patients in the Targeted arm who report positive respiratory symptoms (chronic cough or phlegm, wheeze or dyspnoea) using a brief questionnaire will be invited for further spirometric assessment to ascertain whether they have COPD or not. Post-bronchodilator spirometry will be conducted to ATS standards using an Easy One spirometer by trained research assistants.The primary outcomes will be new cases of COPD and cost per new case identified, comparing targeted case finding with routine care, and two types of targeted case finding (active versus opportunistic). A multilevel logistic regression model will be used to model the probability of detecting a new case of COPD for each treatment arm, with clustering of patients (by practice and household) accounted for using a multi-level structure.A trial-based analysis will be undertaken using costs and outcomes collected during the trial. Secondary outcomes include the feasibility, efficiency, long-term cost-effectiveness, patient and primary care staff views of each approach.DiscussionThis will be the largest RCT of its kind, and should inform how best to identify undiagnosed patients with COPD in the UK and other similar healthcare systems. Sensitivity analyses will help local policy-makers decide which sub-groups of the population to target first.

AB - BackgroundMany people with clinically significant chronic obstructive pulmonary disease (COPD) remain undiagnosed worldwide. There are a number of small studies which have examined possible methods of case finding through primary care, but no large RCTs that have adequately assessed the most cost-effective approach.Methods/DesignIn this study, using a cluster randomised controlled trial (RCT) in 56 general practices in the West Midlands, we plan to investigate the effectiveness and cost-effectiveness of a Targeted approach to case finding for COPD compared with routine practice. Using an individual patient RCT nested in the Targeted arm, we plan also to compare the effectiveness and cost-effectiveness of Active case finding using a postal questionnaire (with supplementary opportunistic questionnaires), and Opportunistic-only case finding during routine surgery consultations.All ever-smoking patients aged 40-79 years, without a current diagnosis of COPD and registered with participating practices will be eligible. Patients in the Targeted arm who report positive respiratory symptoms (chronic cough or phlegm, wheeze or dyspnoea) using a brief questionnaire will be invited for further spirometric assessment to ascertain whether they have COPD or not. Post-bronchodilator spirometry will be conducted to ATS standards using an Easy One spirometer by trained research assistants.The primary outcomes will be new cases of COPD and cost per new case identified, comparing targeted case finding with routine care, and two types of targeted case finding (active versus opportunistic). A multilevel logistic regression model will be used to model the probability of detecting a new case of COPD for each treatment arm, with clustering of patients (by practice and household) accounted for using a multi-level structure.A trial-based analysis will be undertaken using costs and outcomes collected during the trial. Secondary outcomes include the feasibility, efficiency, long-term cost-effectiveness, patient and primary care staff views of each approach.DiscussionThis will be the largest RCT of its kind, and should inform how best to identify undiagnosed patients with COPD in the UK and other similar healthcare systems. Sensitivity analyses will help local policy-makers decide which sub-groups of the population to target first.

KW - COPD

KW - Case-finding

KW - Screening

KW - Primary care

KW - Respiratory questionnaire

KW - Spirometry

KW - Cluster RCT

KW - Cost-effectiveness

U2 - 10.1186/1471-2466-14-157

DO - 10.1186/1471-2466-14-157

M3 - Article

C2 - 25280869

VL - 14

JO - BMC Pulmonary Medicine

JF - BMC Pulmonary Medicine

SN - 1471-2466

IS - 1

M1 - 157

ER -