Evidence map›Paper›PMID 25257804›Full record

Trial reportTrials2014

Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT).

Anna Thit Johnsen, Morten Aagaard Petersen, Christian Gluud, Jane Lindschou, Peter Fayers, Per Sjøgren, Lise Pedersen, Mette Asbjoern Neergaard, Tove Bahn Vejlgaard, Anette Damkier and 4 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01348048 (Danish Palliative Care Trial), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT01348048 phase4completednot on this map

Danish Palliative Care Trial (DanPaCT): A Randomised Clinical Multi-centre Trial Investigating the Effect of Specialised Palliative Care on Symptoms, Survival, Economical Factors and Satisfaction in Patients With Cancer Reporting Palliative Needs

TypeinterventionalSponsorBispebjerg HospitalRan2011 to 2014Enrolled306ConditionsMetastatic CancerArmsSpecialised palliative care (SPC)
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Early palliative care for adults with advanced cancer.The Cochrane database of systematic reviews · 2017
    Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Review
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

14 authors.

Anna Thit JohnsenThe Research Unit, Department of Palliative Medicine, Bispebjerg Hospital, Copenhagen University Hospital, Bispebjerg Hospital 20D, Bispebjerg Bakke 23, Copenhagen NV DK-2400, Denmark. anna.thit.johnsen@regionh.dk.
Morten Aagaard Petersen
Christian Gluud
Jane Lindschou
Peter Fayers
Per Sjøgren
Lise Pedersen
Mette Asbjoern Neergaard
Tove Bahn Vejlgaard
Anette Damkier
Jan Bjoern Nielsen
Annette S Strömgren
Irene J Higginson
Mogens Groenvold

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdvanced cancer patients experience considerable symptoms, problems, and needs. Early referral of these patients to specialized palliative care (SPC) could offer improvements. The Danish Palliative Care Trial (DanPaCT) investigates whether patients with metastatic cancer will benefit from being referred to 'early SPC'. DanPaCT is a multicenter, parallel-group, superiority clinical trial with 1:1 randomization. The planned sample size was 300 patients. The primary data collection for DanPaCT is finished. To prevent outcome reporting bias, selective reporting, and data-driven results, we present a detailed statistical analysis plan (SAP) for DanPaCT here.

resultsThis SAP provides detailed descriptions of the statistical analyses of the primary and secondary outcomes in DanPaCT. The primary outcome is the change in the patient's 'primary need'. The 'primary need' is a patient-individualised outcome representing the score of the symptom or problem that had the highest intensity out of seven at baseline assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Secondary outcomes are the seven scales that are represented in the primary outcome, but each scale evaluated individually for all patients, and survival. The detailed description includes chosen significance levels, models for multiple imputations, sensitivity analyses and blinding. In addition, we discuss the patient-individualized primary outcome, blinding, missing data, multiplicity and the risk of bias.

conclusionsOnly few trials have investigated the effects of SPC. To our knowledge DanPaCT is the first trial to investigate screening based 'early SPC' for patients with metastatic cancer from a broad spectrum of cancer diagnosis.

trial registrationClinicaltrials.gov identifier: NCT01348048 (May 2011).

Indexed as

BiasData Interpretation, StatisticalDenmarkFemaleHumansMaleNeoplasmsPalliative CareQuality of LifeReferral and ConsultationResearch DesignSample SizeTime FactorsTreatment Outcome

Identifiers

PMID25257804
PMCPMC4190470

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Registered trials

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.