title: Reporting of Lost to Follow-Up and Treatment Discontinuation in Pharmacotherapy and Device Trials in Chronic Heart Failure: A Systematic Review.
abstract: Premature treatment discontinuation and loss to follow-up (LTFU) with unknown outcomes leave uncertainty about the true efficacy and safety of a treatment and a lack of confidence in the results of any trial. We reviewed the extent of (and trends over time in) reporting LTFU and treatment discontinuation in large studies in chronic heart failure published since 1990.
  
  
  
  Online databases were systematically reviewed to identify randomized controlled clinical trials (RCTs) in chronic heart failure with >400 participants and utilizing all-cause mortality as a component of the primary or secondary end point. Assessments were made of documentation of treatment discontinuation, LTFU, inclusion of and completeness of a Consolidated Standards Of Reporting Trials (CONSORT) diagram, and whether LTFU was differentiated from withdrawal of consent. Sixty-eight trials were identified, with >154 000 participants. Reasons for treatment discontinuation in pharmacotherapy trials were infrequently reported (35%), particularly in a CONSORT diagram (20%). Eighty-three percent of trials reported LTFU, although only 34% of these differentiated LTFU for vital status from withdrawal of consent. Use of a CONSORT diagram increased over time, although reporting of LTFU in the CONSORT diagram remained low overall at 35%.
  
  
  
  Participant flow through RCTs in chronic heart failure has not been uniformly reported, and the use of a complete CONSORT diagram has been low, although it seems to be improving. All study participants should be accounted for within a CONSORT diagram in any RCT to enable the practicing cardiologist to interpret how the results should influence his/her clinical practice.
authors.affiliation: From the British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (R.T.C., G.P.W., P.S.J., M.C.P., J.J.V.M.); and Division of Cardiology (N.M.H.) and Facutly of Medicine (F.H.), University of British Columbia, Vancouver, Canada.
authors.forename: Ross T
authors.initials: RT
authors.lastname: Campbell
authors.affiliation: From the British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (R.T.C., G.P.W., P.S.J., M.C.P., J.J.V.M.); and Division of Cardiology (N.M.H.) and Facutly of Medicine (F.H.), University of British Columbia, Vancouver, Canada.
authors.forename: Gage P
authors.initials: GP
authors.lastname: Willox
authors.affiliation: From the British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (R.T.C., G.P.W., P.S.J., M.C.P., J.J.V.M.); and Division of Cardiology (N.M.H.) and Facutly of Medicine (F.H.), University of British Columbia, Vancouver, Canada.
authors.forename: Pardeep S
authors.initials: PS
authors.lastname: Jhund
authors.affiliation: From the British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (R.T.C., G.P.W., P.S.J., M.C.P., J.J.V.M.); and Division of Cardiology (N.M.H.) and Facutly of Medicine (F.H.), University of British Columbia, Vancouver, Canada.
authors.forename: Nathaniel M
authors.initials: NM
authors.lastname: Hawkins
authors.affiliation: From the British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (R.T.C., G.P.W., P.S.J., M.C.P., J.J.V.M.); and Division of Cardiology (N.M.H.) and Facutly of Medicine (F.H.), University of British Columbia, Vancouver, Canada.
authors.forename: Flora
authors.initials: F
authors.lastname: Huang
authors.affiliation: From the British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (R.T.C., G.P.W., P.S.J., M.C.P., J.J.V.M.); and Division of Cardiology (N.M.H.) and Facutly of Medicine (F.H.), University of British Columbia, Vancouver, Canada.
authors.forename: Mark C
authors.initials: MC
authors.lastname: Petrie
authors.affiliation: From the British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (R.T.C., G.P.W., P.S.J., M.C.P., J.J.V.M.); and Division of Cardiology (N.M.H.) and Facutly of Medicine (F.H.), University of British Columbia, Vancouver, Canada. john.mcmurray@glasgow.ac.uk.
authors.forename: John J V
authors.initials: JJ
authors.lastname: McMurray
mesh_terms: D058406:Cardiac Resynchronization Therapy / Q000009:adverse effects / Q000401:mortality; D058409:Cardiac Resynchronization Therapy Devices; D002317:Cardiovascular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D017147:Defibrillators, Implantable; D004282:Documentation / Q000592:standards; D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D019983:Guideline Adherence; D006333:Heart Failure / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D059012:Lost to Follow-Up; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards; D012107:Research Design / Q000592:standards; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents
keywords: documentation; heart failure; hospitalization; lost to follow-up; systematic review