Tailored, psychological intervention for anxiety and/or depression in people with chronic obstructive pulmonary disease (COPD), TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD): statistical analysis plan for a randomised controlled trial.
Anxiety
Chronic obstructive pulmonary disease
Clinical effectiveness
Cognitive behavioural approach
Complex intervention
Depression
Internal pilot
Multi-centre
Partial clustering
Pragmatic randomised controlled trial
Pulmonary rehabilitation
Statistical analysis plan
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
15 Oct 2020
15 Oct 2020
Historique:
received:
20
04
2020
accepted:
05
10
2020
entrez:
16
10
2020
pubmed:
17
10
2020
medline:
22
6
2021
Statut:
epublish
Résumé
The aim of the TANDEM trial is to evaluate whether a tailored, psychological cognitive behavioural approach intervention, which links into, and optimises the effects of routine pulmonary rehabilitation (PR), leads to a reduction in mild/moderate anxiety and/or depression in people with moderate, severe or very severe chronic obstructive pulmonary disease. TANDEM is a multi-centre, two-arm, parallel group, pragmatic, individually randomised controlled, superiority trial including an internal pilot. Participants are randomised to receive either the intervention (a tailored psychological intervention plus usual care including referral to PR) or the control (usual care including referral to PR). The designed randomisation ratio is 1.25:1 in favour of the intervention. The multiple-primary outcomes are participant depression and anxiety at 6 months, measured using the Hospital Anxiety and Depression Scale (HADS) depression and anxiety subscales. This article describes the statistical analysis plan (SAP) for the TANDEM trial. In particular, we describe the general analysis principles, how we will handle missing data, the primary and secondary outcomes and how these will be analysed, sensitivity analyses for the multiple-primary outcomes, and any other analyses and data summaries. The SAP was developed and published prior to completion of follow-up of the last participant. ISRCTN registry ISRCTN59537391. Registered on 20 March 2017.
Sections du résumé
BACKGROUND
BACKGROUND
The aim of the TANDEM trial is to evaluate whether a tailored, psychological cognitive behavioural approach intervention, which links into, and optimises the effects of routine pulmonary rehabilitation (PR), leads to a reduction in mild/moderate anxiety and/or depression in people with moderate, severe or very severe chronic obstructive pulmonary disease.
METHODS AND DESIGN
METHODS
TANDEM is a multi-centre, two-arm, parallel group, pragmatic, individually randomised controlled, superiority trial including an internal pilot. Participants are randomised to receive either the intervention (a tailored psychological intervention plus usual care including referral to PR) or the control (usual care including referral to PR). The designed randomisation ratio is 1.25:1 in favour of the intervention. The multiple-primary outcomes are participant depression and anxiety at 6 months, measured using the Hospital Anxiety and Depression Scale (HADS) depression and anxiety subscales.
RESULTS
RESULTS
This article describes the statistical analysis plan (SAP) for the TANDEM trial. In particular, we describe the general analysis principles, how we will handle missing data, the primary and secondary outcomes and how these will be analysed, sensitivity analyses for the multiple-primary outcomes, and any other analyses and data summaries. The SAP was developed and published prior to completion of follow-up of the last participant.
TRIAL REGISTRATION
BACKGROUND
ISRCTN registry ISRCTN59537391. Registered on 20 March 2017.
Identifiants
pubmed: 33059755
doi: 10.1186/s13063-020-04786-1
pii: 10.1186/s13063-020-04786-1
pmc: PMC7559776
doi:
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
858Subventions
Organisme : Department of Health
ID : 13/146/02
Pays : United Kingdom
Organisme : Health Technology Assessment Programme
ID : 13/146/02
Références
Clin Trials. 2007;4(2):125-39
pubmed: 17456512
BMC Med Res Methodol. 2016 Nov 29;16(1):165
pubmed: 27899073
Stat Med. 2013 Mar 30;32(7):1136-49
pubmed: 23112128
J Psychosom Res. 2013 Jan;74(1):74-81
pubmed: 23272992
Patient Educ Couns. 2007 May;66(2):192-201
pubmed: 17320338
J Clin Epidemiol. 2015 Dec;68(12):1504-11
pubmed: 25985892
Acta Psychiatr Scand. 1983 Jun;67(6):361-70
pubmed: 6880820
J Psychosom Res. 2006 Jun;60(6):631-7
pubmed: 16731240
Am J Respir Crit Care Med. 1998 Oct;158(4):1185-9
pubmed: 9769280
BMJ. 2011 Feb 07;342:d40
pubmed: 21300711
Stat Med. 2012 Feb 20;31(4):328-40
pubmed: 22139891
BMC Med Res Methodol. 2018 Oct 11;18(1):105
pubmed: 30314463
Gerontologist. 1980 Dec;20(6):649-55
pubmed: 7203086
Psychother Res. 2017 Jul;27(4):425-436
pubmed: 26686878
Health Qual Life Outcomes. 2007 Nov 27;5:63
pubmed: 18042300
J R Soc Med. 2018 Apr;111(4):143-144
pubmed: 29648508
Stat Med. 2005 Apr 15;24(7):993-1007
pubmed: 15570623
Biometrics. 1946 Dec;2(6):110-4
pubmed: 20287815
BMC Med Res Methodol. 2016 Apr 11;16:42
pubmed: 27068456
JAMA. 2017 Dec 19;318(23):2337-2343
pubmed: 29260229
J Clin Epidemiol. 2010 Aug;63(8):e1-37
pubmed: 20346624
Trials. 2020 Jan 6;21(1):18
pubmed: 31907074