title: Statistical analysis plan for the HEAT trial: a multicentre randomised placebo-controlled trial of intravenous paracetamol in intensive care unit patients with fever and infection.
abstract: OBJECTIVE
  We describe the statistical analysis plan (SAP) for the Permissive Hyperthermia through Avoidance of Paracetamol in Known or Suspected Infection in the Intensive Care Unit (HEAT) trial, a 700-patient, prospective, randomised, Phase 2b, multicentre, double-blind, parallel-groups, placebo-controlled trial of paracetamol administration for the treatment of fever in critically ill patients with known or suspected infection.
  
  
  METHODS
  The data fields described are those outlined in the study protocol published previously. We describe the plan for the presentation and comparison of baseline characteristics, process measures and outcomes. We describe baseline characteristics, and define and categorise trial outcomes according to their assigned importance.
  
  
  CONCLUSIONS
  We developed an SAP for the HEAT trial, and produced a mock Consolidated Standards of Reporting Trials diagram and tables. Our prespecified SAP accords with high-quality standards of internal validity and should minimise future analysis bias.
authors.affiliation: Intensive Care Unit, Wellington Regional Hospital, Wellington, New Zealand.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Young
authors.forename: Mark
authors.initials: M
authors.lastname: Weatherall
authors.forename: Manoj K
authors.initials: MK
authors.lastname: Saxena
authors.forename: Rinaldo
authors.initials: R
authors.lastname: Bellomo
authors.forename: Ross C
authors.initials: RC
authors.lastname: Freebairn
authors.forename: Naomi E
authors.initials: NE
authors.lastname: Hammond
authors.forename: Frank Mp van
authors.initials: FM
authors.lastname: Haren
authors.forename: Seton J
authors.initials: SJ
authors.lastname: Henderson
authors.forename: Colin J
authors.initials: CJ
authors.lastname: McArthur
authors.forename: Shay P
authors.initials: SP
authors.lastname: McGuinness
authors.forename: Diane
authors.initials: D
authors.lastname: Mackle
authors.forename: John A
authors.initials: JA
authors.lastname: Myburgh
authors.forename: Steve A R
authors.initials: SA
authors.lastname: Webb
authors.forename: Richard W
authors.initials: RW
authors.lastname: Beasley
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage / Q000627:therapeutic use*; D061605:Administration, Intravenous; D058633:Antipyretics / Q000008:administration & dosage / Q000627:therapeutic use*; D017322:Clinical Trials, Phase II as Topic; D003422:Critical Care / Q000379:methods*; D003627:Data Interpretation, Statistical; D005334:Fever / Q000188:drug therapy*; D006801:Humans; D007239:Infections / Q000188:drug therapy*; D007362:Intensive Care Units; D057194:Intention to Treat Analysis; D009520:New Zealand; D017063:Outcome Assessment, Health Care; D012107:Research Design
chemical_list: D058633:Antipyretics; D000082:Acetaminophen