title: Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT).
abstract: BACKGROUND
  Advanced 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.
  
  
  RESULTS
  This 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.
  
  
  CONCLUSIONS
  Only 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.
  
  
  BACKGROUND
  Clinicaltrials.gov identifier: NCT01348048 (May 2011).
authors.affiliation: The 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.
authors.forename: Anna Thit
authors.initials: AT
authors.lastname: Johnsen
authors.forename: Morten Aagaard
authors.initials: MA
authors.lastname: Petersen
authors.forename: Christian
authors.initials: C
authors.lastname: Gluud
authors.forename: Jane
authors.initials: J
authors.lastname: Lindschou
authors.forename: Peter
authors.initials: P
authors.lastname: Fayers
authors.forename: Per
authors.initials: P
authors.lastname: Sjøgren
authors.forename: Lise
authors.initials: L
authors.lastname: Pedersen
authors.forename: Mette Asbjoern
authors.initials: MA
authors.lastname: Neergaard
authors.forename: Tove Bahn
authors.initials: TB
authors.lastname: Vejlgaard
authors.forename: Anette
authors.initials: A
authors.lastname: Damkier
authors.forename: Jan Bjoern
authors.initials: JB
authors.lastname: Nielsen
authors.forename: Annette S
authors.initials: AS
authors.lastname: Strömgren
authors.forename: Irene J
authors.initials: IJ
authors.lastname: Higginson
authors.forename: Mogens
authors.initials: M
authors.lastname: Groenvold
mesh_terms: D015982:Bias; D003627:Data Interpretation, Statistical; D003718:Denmark; D005260:Female; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000150:complications / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D010166:Palliative Care / Q000706:statistics & numerical data*; D011788:Quality of Life; D012017:Referral and Consultation / Q000706:statistics & numerical data*; D012107:Research Design / Q000706:statistics & numerical data*; D018401:Sample Size; D013997:Time Factors; D016896:Treatment Outcome