ONLINE RESOURCE 1 Article Title: A Review of the Economic Tools for Assessing New Medical Devices This resource provides the search strategies and sources to identify: a) b) c) Unique characteristics and methods; Economic evaluations; Data extraction table. A. SUPPLEMENTARY INFORMATION – SEARCH STRATEGIES AND SOURCES FOR UNIQUE CHARACTERISTICS AND METHODS A.1 Find Guidance for Australia, Canada, Sweden, Denmark and France Guidance was identified by searching the following websites on 20 January 2012: 1.1 1.2 1.3 1.4 1.5 Australia: Medical Services Advisory Committee (MSAC) http://www.msac.gov.au/ Canada: CADTH. http://www.cadth.ca/ Sweden: SBU http://www.sbu.se/en/ Denmark: National Board of Health http://www.sst.dk/ France: HAS http://www.has-sante.fr/portail/jcms/j_5/home A.2 Searches For Methods Papers on Unique Characteristics of Devices and Diagnostics and Also Papers by Known Authors in the Field Were Undertaken In a Series of Databases Econlit <1961 to December 2011> (OvidSP), searched 19 January 2012: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. medical device$1.ti,ab. (66) from 1 keep 7,13,25-29,34,41,47,49-50 (12) ((diagnostic or diagnosis) adj4 (evaluat$ or assess$ or regulat$ or reimburse$)).ti,ab. (88) from 3 keep 31,35,71,73,75 (5) (medical technolog$ adj5 (evaluat$ or assess$ or regulat$ or reimburs$)).ti,ab. (13) 5 not (1 or 3) (11) from 6 keep 1,3,5-6 (4) (DEVICE$1 adj5 (evaluat$ or assess$ or regulat$ or reimburs$)).ti,ab. (75) 8 not (1 or 3 or 5) (60) drummond m$.au. (48) from 10 keep 13 (1) hutton j$.au. and (device$ or diagnos$ or technol$).ti,ab. (2) from 12 keep 2 (1) taylor r$.au. and (device$ or diagnos$ or technol$ or evaluat$ or reimburs$ or assess$).ti,ab. (17) hutton j$.au. and (evaluat$ or reimburs$ or assess$).ti,ab. (6) tarricone r$.au. (1) or/2,4,7,11 (22) Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations and Ovid MEDLINE(R) <1946 to Present>, searched 19 January 2012: 1 2 3 4 5 6 7 8 9 drummond m$.au. (511) hutton j$.au. and (device$ or diagnos$ or technol$).ti,ab. (87) hutton j$.au. and (evaluat$ or reimburs$ or assess$).ti,ab. (145) tarricone r$.au. (18) taylor r.au. and (device$ or diagnos$ or technol$ or evaluat$ or reimburs$ or assess$).ti,ab. (387) taylor rs.au. and (device$ or diagnos$ or technol$ or evaluat$ or reimburs$ or assess$).ti,ab. (113) or/1-6 (1216) limit 7 to yr="2007 -Current" (355) from 8 keep 1,24,34,57,63,68,90,147,160-161,166,186,192,223,228,248249,264,312 (19) In addition to these strategies the ‘find similar’ and ‘citing references’ options were used with results from set 9 and these identified some further papers. ISPOR http://www.ispor.org/research_study_digest/index.asp, searched 19 January 2012: Search terms: devices 2011-2008 Search term: diagnostic, 2011-2008 IDEAS http://ideas.repec.org/, searched 19 January 2012: (medical devices | diagnostic | diagnosis) |evaluations|assessment|assessments|reimbursement|reimbursing)+(medical |health|healthcare) 2000-2011 +(evaluation 249 records and of these 5 records were downloaded. International Journal of Technology Assessment in Health Care was searched full text on 24 January 2012: Searched ‘device’ (picks up devices as well via automatic truncation) Searched ‘diagnostic ‘ NBER http://www.nber.org/, searched 24 January 2012: Searched ‘medical devices economic evaluation’ – full text search of publications Searched ‘diagnostic economic evaluation’ – full text search of publications A.3 Searches for Research on Specific Methods Econlit <1961 to December 2011> (OvidSP), searched 24 January 2012: 1 2 3 4 5 6 7 8 9 14 15 16 cost consequence$1.ti,ab. (21) cost minimi$.ti,ab. (578) (early model$1 or early modelling).ti,ab. (20) ((bayes or bayesian) adj5 (economic evaluation$1 or model$1 or modelling or cost effectiveness)).ti,ab. (1852) (value adj3 information).ti,ab. (1025) (value adj3 sampling).ti,ab. (9) (elicitation or eliciting).ti,ab. (760) or/1-7 (4234) limit 8 to yr="1990 -Current" (3950) (health or medical or device$1 or diagnos$ or technolog$).ti,ab,jw. (85420) 9 and 14 (610) 15 not 13 (589) HMIC (OvidSP) 1979 to Nov 2011, searched 24 January 2012: 1 2 3 4 5 6 7 8 9 10 11 12 cost consequence$1.ti,ab. (21) cost minimi$.ti,ab. (578) (early model$1 or early modelling).ti,ab. (20) ((bayes or bayesian) adj5 (economic evaluation$1 or model$1 or modelling or cost effectiveness)).ti,ab. (1852) (value adj3 information).ti,ab. (1025) (value adj3 sampling).ti,ab. (9) (elicitation or eliciting).ti,ab. (760) or/1-3 or/4-7 (medical technolog$ or healthcare technol$ or care technol$ or device$1 or diagnos$ or technolog$).ti,ab,jw. (12249) 9 and 10 (31) 8 or 11 (161) MEDLINE Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations and Ovid MEDLINE(R) 1946 to Present, searched 24 January 2012: 1 2 3 4 5 6 7 8 9 (cost consequence$1 adj5 (medical technolog$ or healthcare technol$ or care technol$ or device$1 or diagnos$ or technolog$ assess$)).mp. [mp=title, abstract, original title, name of substance word, subject heading word, protocol supplementary concept, rare disease supplementary concept, unique identifier] (2) (cost minim$ adj5 (medical technolog$ or healthcare technol$ or care technol$ or device$1 or diagnos$ or technolog$ assess$)).mp. (18) (early adj3 model$ adj5 (medical technolog$ or healthcare technol$ or care technol$ or device$1 or diagnos$ or technolog$ assess$)).mp. (56) (bayesian adj5 (medical technolog$ or healthcare technol$ or care technol$ or device$1 or diagnos$ or technolog$ assess$)).mp. (225) (value adj3 information adj5 (medical technolog$ or healthcare technol$ or care technol$ or device$1 or diagnos$ or technolog$ assess$)).mp. (107) (value adj3 sampling adj5 (medical technolog$ or healthcare technol$ or care technol$ or device$1 or diagnos$ or technolog$ assess$)).mp. (17) ((elicitation or eliciting) adj5 (medical technolog$ or healthcare technol$ or care technol$ or device$1 or diagnos$ or technolog$ assess$)).mp. (59) or/1-7 (483) limit 8 to (english language and yr="1990 -Current") (331) B. DETAILS OF SEARCH AND SAMPLING STRATEGY FOR ECONOMIC EVALUATIONS Details of search and sampling strategy taken from NUTH, Regional Medical Physics Department Cost Consequences of Innovation Research Topic; E Colechin, C Rudland and A Sims, March 2011 Method (Section 3.2) From previous experience of performing literature searches relating to medical devices and diagnostics, including ‘AND medical device’ in the search term leads to relevant papers being excluded as the term medical device does not generally appear in the title or abstract or in the list of keywords. In general, if a paper is specifically about a device, it will use its name and/or type to describe it rather than the generic term medical device. Using the term ‘OR medical device’ increases sensitivity at the expense of specificity. The same is true for the terms diagnostics and innovation. Due to difficulties in identifying or classifying when a medical device or diagnostic is innovative, we have assumed that at the time of publication the medical technology referred to in each paper was innovative. The approach taken in defining the search terms for this research question was to optimise sensitivity. A drawback to using sensitive search terms is the high number of results returned. Where high numbers (i.e. >400 results) were returned, we randomly selected 100 abstracts from each year between 2007 and 2010, to give a representative sample of the results. Two search terms were applied in MEDLINE to ascertain relevant papers: • • “Systematic review” [any field]; “Meta-analysis” [any field] OR meta-analysis [mesh heading]. One reviewer examined the abstracts, identifying papers that related directly to a medical device, diagnostic, or technology, or considered a procedure or intervention that used a specific medical technology. Papers were excluded if they related to: • • • • Disease; Pharmaceuticals; Clinical procedures or interventions not specifically using medical technology; Methodology of systematic reviews or meta-analysis. Three search terms were applied in MEDLINE to ascertain relevant papers: • • • “Cost consequences” [any field]; Cost-benefit analysis [mesh heading] OR “cost effectiveness” [any field] OR “cost minimisation” [any field] OR “cost utility” [any field]; Models, economic [mesh heading] OR “economic modelling” [any field]. One reviewer examined the abstracts, identifying papers that related directly to a medical device, diagnostic, or technology or considered a procedure or intervention that used specific medical technology. Papers were excluded if they related to: • • • • • • Disease; Pharmaceuticals; Animals; Ecology; Clinical procedures or interventions not specifically using medical technology; Methodology of economic evaluation techniques. Results (Section 5.3) The search term “cost consequence” returned 166 results (February 2011). Of these, eleven were relevant to medical devices and diagnostics. The search term considering other economic evaluation techniques (i.e. cost-benefit analysis, cost effectiveness analysis, cost minimisation analysis and cost utility analysis) returned 60,173 results (February 2011). Of these, 3,226 papers were published in 2010, 3,610 papers in 2009, 3,338 papers in 2008 and 3,189 papers in 2007. Of the 100 randomly selected papers for each of these years, eight in 2010 related to medical devices and diagnostics, eight in 2009, six in 2008 and two in 2007. The search term considering economic modelling returned 4,386 results (February 2011). Of these, 397 papers were published in 2010, 459 papers in 2009, 415 papers in 2008 and 322 papers in 2007. Of the 100 randomly selected papers for each of these years seven in 2010 related to medical devices and diagnostics, nine in 2009, four in 2008 and six in 2007. The 11 papers identified in the cost consequences papers considered eight medical devices or technologies, listed in Table B.1. The 24 papers identified in the economic evaluation sample considered 23 medical devices, technologies, and diagnostics. The 26 papers identified in the economic modelling sample considered 24 medical devices and technologies (Table B.1). Table B.1: List of medical devices, technologies and diagnostics included in the samples of identified papers for cost consequences, economic evaluation techniques and economic modelling samples Cost consequences papers Blood cell salvage [105] Cochlear implant [104] Coronary CT angiography [111] Electronic decision support system [110] High-energy transurethral microwave thermotherapy [103] Intraocular lens [106-109] Spinal cord stimulation [102] Ultrafiltration [101] Economic evaluation techniques sample Array-based comparative genomic hybridisation [134] Bone fixation plates and screws [116] Cardiac imaging [133] Cardiac resynchronisation therapy devices [69] C-leg microprocessor-controlled prosthetic knee [114] CT [128] Cyberknife [132] Dual X-ray absorptiometry scanners [124] Economic modelling sample Adjustable gastric band [142] Bare metal stent [137, 149] Bio-electric stimulation therapy [157] Carotid artery stent [135] Coronary computed tomography angiography [154, 156] Dental bridge [145] Dental implant [145] Doppler ultrasound [151, 156] Drug-eluting stent [137, 140, 147-149] Dual X-ray absorptiometry scanners [124] Electrocautery devices [131] Extracorporeal membrane oxygenation machine [125] Heat and moisture exchangers [121] Hip prostheses [113, 130] Implantable cardiac devices [127] Implantable cardioverter defibrillators [126] Orthopaedic implants [120] PET [123] Photodynamic therapy lamps [118] Robotic-assisted surgery system [117] Stimulators for fracture healing [122] Sutures and staples [115] Ultrasonic dissector [112] Ureteroscopes [129] NaviVision and Arcadis Orbis image guidance systems [119] Electrocardiogram [141] Endoscopy [153] Endovascular aneurysm repair [146] Intrathecal baclofen therapy [144] Magnetic resonance angiography [156] Optical computed tomography [155] PET [143] PET/CT [158] Photodynamic therapy [139] Radiofrequency ablation [136] Radiotherapy [150] Self-injectable epinephrine [159] Semi-quantitative urine dipsticks [152] Total body hypothermia [138] Please note the numbers in this list link the paper to Table B.1. 69. 101. 102. 103. 104. 105. 106. 107. 108. 109. 110. 111. 112. 113. 114. 115. 116. 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DATA EXTRACTION SHEET FOR PUBLISHED EVALUATIONS Study Details: Title: Date/Source: Overview Question Device or Diagnostic? Aim of study Justification/reason for study Technology Is technology established or new? Type of economic analysis (cost consequence etc.) Timeframe of model Options for response Specify which List quoted aim from paper For example, new technology, more data for existing one etc. Please list all covered Please specify Response Please list Please state Unique Characteristics: Does the paper explicitly refer to listed characteristics and if so how are they addressed. If no, can this be assessed from paper? Unique Characteristic Learning curve effect Incremental innovation Data quality issues Organisational impact of introducing new devices Diagnostics only: Distance from outcomes (Testplus-treatment-strategy/outcomes) How does study account for outcomes? Any other unique characteristics referenced for either devices or diagnostics? If yes, please list and provide brief details Yes/ No Details OVERALL In the opinion of the reviewer was a better analysis of outcomes feasible without major changes to the study design?