title: Evaluating complex interventions in end of life care: the MORECare statement on good practice generated by a synthesis of transparent expert consultations and systematic reviews.
abstract: BACKGROUND
  Despite being a core business of medicine, end of life care (EoLC) is neglected. It is hampered by research that is difficult to conduct with no common standards. We aimed to develop evidence-based guidance on the best methods for the design and conduct of research on EoLC to further knowledge in the field.
  
  
  METHODS
  The Methods Of Researching End of life Care (MORECare) project built on the Medical Research Council guidance on the development and evaluation of complex circumstances. We conducted systematic literature reviews, transparent expert consultations (TEC) involving consensus methods of nominal group and online voting, and stakeholder workshops to identify challenges and best practice in EoLC research, including: participation recruitment, ethics, attrition, integration of mixed methods, complex outcomes and economic evaluation. We synthesised all findings to develop a guidance statement on the best methods to research EoLC.
  
  
  RESULTS
  We integrated data from three systematic reviews and five TECs with 133 online responses. We recommend research designs extending beyond randomised trials and encompassing mixed methods. Patients and families value participation in research, and consumer or patient collaboration in developing studies can resolve some ethical concerns. It is ethically desirable to offer patients and families the opportunity to participate in research. Outcome measures should be short, responsive to change and ideally used for both clinical practice and research. Attrition should be anticipated in studies and may affirm inclusion of the relevant population, but careful reporting is necessitated using a new classification. Eventual implementation requires consideration at all stages of the project.
  
  
  CONCLUSIONS
  The MORECare statement provides 36 best practice solutions for research evaluating services and treatments in EoLC to improve study quality and set the standard for future research. The statement may be used alongside existing statements and provides a first step in setting common, much needed standards for evaluative research in EoLC. These are relevant to those undertaking research, trainee researchers, research funders, ethical committees and editors.
authors.affiliation: King's College London, Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation, Bessmer Road, Denmark Hill, London SE5 9PJ, UK. irene.higginson@kcl.ac.uk
authors.forename: Irene J
authors.initials: IJ
authors.lastname: Higginson
authors.forename: Catherine J
authors.initials: CJ
authors.lastname: Evans
authors.forename: Gunn
authors.initials: G
authors.lastname: Grande
authors.forename: Nancy
authors.initials: N
authors.lastname: Preston
authors.forename: Myfanwy
authors.initials: M
authors.lastname: Morgan
authors.forename: Paul
authors.initials: P
authors.lastname: McCrone
authors.forename: Penney
authors.initials: P
authors.lastname: Lewis
authors.forename: Peter
authors.initials: P
authors.lastname: Fayers
authors.forename: Richard
authors.initials: R
authors.lastname: Harding
authors.forename: Matthew
authors.initials: M
authors.lastname: Hotopf
authors.forename: Scott A
authors.initials: SA
authors.lastname: Murray
authors.forename: Hamid
authors.initials: H
authors.lastname: Benalia
authors.forename: Marjolein
authors.initials: M
authors.lastname: Gysels
authors.forename: Morag
authors.initials: M
authors.lastname: Farquhar
authors.forename: Chris
authors.initials: C
authors.lastname: Todd
mesh_terms: D035843:Biomedical Research / Q000379:methods / Q000592:standards; D006801:Humans; D017410:Practice Guidelines as Topic; D011787:Quality of Health Care / Q000592:standards*; D013727:Terminal Care / Q000379:methods*