Evidence map›Paper›PMID 33059755›Full record

Trial reportTrials2020

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.

Claire L Chan, Melanie Smuk, Ratna Sohanpal, Hilary Pinnock, Stephanie J C Taylor, TANDEM Investigators

Open access · goldAbstract readMulticenter StudyRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 38% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Correlation of Serum IL-18, BDNF, and IL-1Computational and mathematical methods in medicine · 2022
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

Claire L ChanInstitute of Population Health Sciences, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK. c.l.chan@qmul.ac.uk.ORCID http://orcid.org/0000-0002-0821-4068
Melanie SmukLondon School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
Ratna SohanpalInstitute of Population Health Sciences, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK.
Hilary PinnockAllergy and Respiratory Research Group, Usher Institute, The University of Edinburgh, Doorway 3, Medical School, Teviot Place, Edinburgh, EH8 9AG, UK.
Stephanie J C TaylorInstitute of Population Health Sciences, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK.
TANDEM Investigators
Queen Mary University of London · GBUniversity of Edinburgh · GBUniversity of London · GB

Funding

Department of Health 13/146/02Health Technology Assessment Programme 13/146/02
6 · The paper itself

Abstract

backgroundThe 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

designTANDEM 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.

resultsThis 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 registrationISRCTN registry ISRCTN59537391. Registered on 20 March 2017.

Indexed as

DepressionPulmonary Disease, Chronic ObstructiveAnxietyCost-Benefit AnalysisHumansPsychosocial InterventionQuality of LifeAnxietyChronic obstructive pulmonary diseaseClinical effectivenessCognitive behavioural approachComplex interventionDepressionInternal pilotMulti-centrePartial clusteringPragmatic randomised controlled trialPulmonary rehabilitationStatistical analysis plan

Identifiers

PMID33059755
PMCPMC7559776
OpenAlexW3092781917

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.