Strategies and Best Practice For Adoption of Medical Technology Davy Cheng, MD MSc FRCPC FCAHS Distinguished University Professor & Chair / Chief Department of Anesthesia & Perioperative MedicineEvidence-Based Perioperative Clinical Outcomes Research (EPiCOR) London Health Sciences Centre/St Joseph’s Health Care London University of Western Ontario
OBJECTIVES Slide Title Goes Here To discuss innovation, role of HTA and KT To discuss the challenges of knowledge translation to best practice at MD-Patient level To discuss the Strategies to facilitate HTA adoption process within Health Institutions
What is ‘innovation’? A new way of doing something or A way of doing something new? Must it be substantially different to be innovative? Health Canada: “An innovation represents effective treatment, prevention or diagnosis of a disease or condition for which no drug (or medical device) is currently licensed in Canada.”
ENIAC Computer The first mainframe computer in 1946 took up 1800 sq. ft. of floor space and weighed 30 tons!
Accountability A Brown, ADM; S FitzPatrick, ADM; T Huynh, Director
Health Technology Assessment Health Technology is broadly defined to include the drugs, devices, medical and surgical procedures, as well as measures for prevention and rehabilitation of disease, and the organisational and support systems in which health care is provided. HTA seeks to inform health policy makers by using best scientific evidence on the medical, social, economical and ethical implications of investments in Health Care.
Health CanadaMedical Devices Program the program monitors and evaluates the safety, efficacy and quality of diagnostic and therapeutic medical devices so that consumers and health care professionals can use them with confidence.
HTA Gate-Keeper: Hospitals / MDs? Health Canada (Drugs & Devices Licensed for Market) Pre market Procedures Drugs Devices & Machines Postmarket Canadian HTA Agency (CADTH) Advice on New Drugs from CEDAC (non-binding) Ontario MOH Drug Committee (CED) Drug reimbursement policy for pts >65y or on social assistance (non-hospital) Ontario MOH HTA Committee (OHTAC) Advice on non-drug technologies (non-binding) Ontario Hospitals (ad hoc decision-making) *evidence exists, but few decisions are made in full light of the evidence* Consumers
Strategies to improve organization in support of evidence-informed health policymaking
Knowledge Translation Gaps in KT and Decision Making Research Publication Knowledge Translation Patients - Guidelines, Consensus Statements -Technology, Technique, Monitor, Tests
Hospital HTA: Local decision-makers need to consider • Local priority • Local operations • Local population health needs • Local alternatives • Local presence of trained personnel • Local infrastructures & resources • Local budget impact…….. • As well as HTAs by HTA agencies
Anesthesia & Perioperative Medicine, Surgery, Critical Care
Hospital HTA: EPiCOR-HiTEC Know4Go Create timely and contextualized evidence-based reviews for high-stakes intra-operative and perioperative therapies Translate evidence to definitive decisions using the Know4Go Framework Develop and Implement policy with supporting tools, and build institution-wide capacity for Know4go-informed decision-making Evaluate the impact to Quality and Costs Slide Title Goes Here
Unsound Research (5) (1) Aware Accepted Applicable Able Acted on Agreed Adhered to Sound Research (3) Systems (bottomline +/- ref) Synopses (user summary of research) Systematic Reviews and CATs (search; appraise; synthesis) Quality Improvement
Too Early or Too Late Adopters? Drug, Technology, Technique – Context!
Medial Device or Surgical Innovation Surgical innovation - the stakes are high. Surgical research and innovation is more personal and intimate. It is not just the failure of a drug, a new device, it is always possibly the failure of the operator. unique conflict of interest: surgeons determine both who needs surgery and performs the operation once that decision is made. Development process and Learning curve – as innovator and early adopters
How Do We Introduce Innovation In This New Era? Define innovation and openly address the efficacy and safety. Set up innovation task force or formal departmental or institutional organization to assist the innovators. Precautionary principle. Perform well-designed feasibility trials. Informed consent.
Managing the Learning Curve Review the disease process. Review results with alternative procedures. Adequately train prior to initiating a clinical program with didactic course work, video review, and case observation, when possible. Carefully monitor and review morbidity and mortality. Case-by-case analysis CUSUM curves
Rogers, et al J ThoracCardiovascSurg 2004;128:811-819
Clinical Simulation Training Center Innovation HTA Assessment Training KT Cycle
When is a procedure ready to disseminate to the wider medical community? Postpone widespread adoption until scientific evidence of efficacy and safety is available. Assurance that the innovator has defined his own learning curve (simulation) Proper HTA Develop training programs and competency guidelines for new procedures