title: A novel research design can aid disinvestment from existing health technologies with uncertain effectiveness, cost-effectiveness, and/or safety.
abstract: OBJECTIVE
  Disinvestment is critical for ensuring the long-term sustainability of health-care services. Key barriers to disinvestment are heterogeneity between research and clinical settings, absence of evidence of effectiveness of some health technologies, and exposure of patients and organizations to risks and poor outcomes. We aimed to develop a feasible research design that can evaluate disinvestment in health technologies of uncertain effectiveness or cost-effectiveness.
  
  
  METHODS
  This article (1) establishes the need for disinvestment methodologies, (2) identifies the ethical concerns and feasibility constraints of conventional research designs for this issue, (3) describes the planning, implementation, and analytical framework for a novel disinvestment-specific study design, and (4) describes potential limitations in application of this design.
  
  
  RESULTS
  The stepped-wedge, roll-in cluster randomized controlled trial can facilitate the disinvestment process, whereas generating evidence to determine whether the decision to disinvest was sound in the clinical environment. A noninferiority research paradigm may be applied to this methodology to demonstrate that the removal of a health technology does not adversely affect outcomes.
  
  
  CONCLUSIONS
  This research design can be applied across multiple fields and will assist determination of whether specific health technologies are clinically effective, cost-effective, and safe.
authors.affiliation: Allied Health Research Unit, Monash Health, Kingston Centre, Kingston Rd, Cheltenham, Victoria 3192, Australia; Physiotherapy Department, Southern Physiotherapy Clinical School, Monash University, Peninsula Campus, McMahon's Rd, Frankston, Victoria 3199, Australia. Electronic address: terrence.haines@monash.edu.
authors.forename: Terry
authors.initials: T
authors.lastname: Haines
authors.affiliation: Department of Occupational Therapy, Monash University, Peninsula Campus, McMahon's Rd, Frankston, Victoria 3199, Australia; Department of Occupational Therapy, The Alfred, 55 Commercial Rd, Melbourne, Victoria 3004, Australia.
authors.forename: Lisa
authors.initials: L
authors.lastname: O'Brien
authors.affiliation: Department of Social Work, Faculty of Medicine Nursing and Health Sciences, Monash University and Southern Health, PO Box 197, Caulfield East, Victoria 3156, Australia; Social Work Department, Monash Medical Centre, Clayton Rd, Clayton, Victoria 3168, Australia.
authors.forename: Fiona
authors.initials: F
authors.lastname: McDermott
authors.affiliation: Monash Health, Monash Medical Centre, Clayton Rd, Clayton, Victoria 3168, Australia.
authors.forename: Donna
authors.initials: D
authors.lastname: Markham
authors.affiliation: Monash Health, Monash Medical Centre, c/Site Management, 246 Clayton Rd, Clayton, Victoria 3168, Australia.
authors.forename: Deb
authors.initials: D
authors.lastname: Mitchell
authors.affiliation: Department of Occupational Therapy, Caulfield Hospital, Alfred Health, 60 Kooyong Rd, Caulfield, Victoria 3162, Australia.
authors.forename: Dina
authors.initials: D
authors.lastname: Watterson
authors.affiliation: Physiotherapy Department, Sunshine Hospital, Western Health, Furlong Rd, St Albans, Victoria 3021, Australia.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Skinner
mesh_terms: D020811:Biomedical Technology / Q000191:economics / Q000458:organization & administration* / Q000592:standards*; D003362:Cost-Benefit Analysis; D003695:Delivery of Health Care / Q000191:economics / Q000458:organization & administration* / Q000592:standards*; D019317:Evidence-Based Medicine; D006801:Humans; D012107:Research Design; D013673:Technology Assessment, Biomedical; D035501:Uncertainty
keywords: Comparative efficacy; Disinvestment; Health; Non-inferiority; Roll-in; Stepped wedge