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Assessing New Technologies in Surgery: Case Example of Acute Primary Repair of the Thumb Ulnar Collateral Ligament

      Purpose

      Health technology assessment provides a means to assess the technical properties, safety, efficacy, cost-effectiveness, and ethical/legal/social impact of a novel technology. An important component of health technology assessment is the cost-effectiveness analysis (CEA), which can be performed using model-based CEA. This study used the CEA model to compare the cost-effectiveness of a novel ligament augmentation device with the standard technique for primary repair of complete ulnar collateral ligament (UCL) tears.

      Methods

      A model was developed for complete UCL tear requiring acute surgical repair, comparing the cost-effectiveness of standard technique primary repair and repair using a ligament augmentation device from a societal perspective. Primary outcomes included quality-adjusted life years (QALYs), cost, net monetary benefit (NMB) and incremental NMB. A cost-effectiveness threshold of CAD $50,000/QALY was used to compare the 2 techniques. Sensitivity analyses were conducted to assess the parameter uncertainty, specifically the impact of device cost, time off work, probability of complication, and postoperative outcome.

      Results

      The NMB for the standard technique was CAD $42,598, and the NMB for repair using the ligament augmentation device was CAD $41,818. The standard technique was the preferred strategy for primary repair of complete UCL tears. One-way sensitivity analyses demonstrated that the ligament augmentation device became cost-effective if individuals return to work in <18 days (base case 23 days). The device was also favored when the cost was less than CAD $50 and the difference in time to return to work was at least 1 day.

      Conclusions

      Our model demonstrates that there may be significant costs associated with the introduction of novel health technologies, and certain conditions, such as an earlier return to work, must be met for some devices to be a cost-effective option. This study provides an example of how model-based CEA is a useful tool to assess the cost-effectiveness of a novel device.

      Type of study/level of evidence

      Economic/Decision Analysis II.

      Key words

      The rapid pace of technological advancement within surgical practice necessitates a process to evaluate novel health technology prior to its clinical adoption. Health technology assessment (HTA) provides a systematic means for evaluating properties, effects, and impact of health technologies.
      • Goodman C.S.
      Fundamental concepts.
      The 5 main facets of HTA include (1) technical properties/performance characteristics, (2) safety, (3) efficacy/effectiveness, (4) economic attributes, and (5) social, legal, ethical, and/or political impact of the technology.
      • Goodman C.S.
      Fundamental concepts.
      To evaluate some of these facets for novel surgical devices, Poulin et al
      • Poulin P.
      • Austen L.
      • Rudmik L.
      • Schuler T.
      The evidence decision support program within the surgery strategic clinical network of Alberta Health Services in Canada.
      advocated for the development of cost-effectiveness models.
      Clinical decision analysis (CDA) informs medical decision-making by simulating various available treatment options.
      • Graham B.
      • Detsky A.S.
      The application of decision analysis to the surgical treatment of early osteoarthritis of the wrist.
      It is a method of quantitative assessment of the numerous factors involved when choosing a treatment strategy, and it is often used to support clinical guidelines.
      • Graham B.
      • Detsky A.S.
      The application of decision analysis to the surgical treatment of early osteoarthritis of the wrist.
      Similarly, cost-effectiveness analysis (CEA) compares the relative costs and benefits associated with various treatment options to improve the value of health care interventions.
      • Sher D.J.
      • Punglia R.S.
      Decision analysis and cost-effectiveness analysis for comparative effectiveness research--a primer.
      Model-based CEA incorporates cost-effectiveness data and clinical outcomes, and it can inform policy decisions when economic data are part of the evidence considered by decision-makers.
      • Ryder H.F.
      • McDonough C.
      • Tosteson A.N.
      • et al.
      Decision analysis and cost-effectiveness analysis.
      In the context of HTA, model-based CEA allows decision-makers to anticipate the clinical benefits and cost-effectiveness of new technologies and to compare novel strategies to current standards.
      An example of a novel technology in hand surgery is a new ligament augmentation device (InternalBrace; Arthrex) that aids in ulnar collateral ligament (UCL) repair in the metacarpophalangeal joint (MCPJ) of the thumb. This device has wide applicability, as UCL injuries account for 86% of all MCPJ injuries.
      • Rhee P.C.
      • Jones D.B.
      • Kakar S.
      Management of thumb metacarpophalangeal ulnar collateral ligament injuries.
      • Avery 3rd, D.M.
      • Inkellis E.R.
      • Carlson M.G.
      Thumb collateral ligament injuries in the athlete.
      • Katolik L.I.
      • Friedrich J.
      • Trumble T.E.
      Repair of acute ulnar collateral ligament injuries of the thumb metacarpophalangeal joint: a retrospective comparison of pull-out sutures and bone anchor techniques.
      • Picard F.
      • Khalifa H.
      • Dubert T.
      Duration of sick leave after surgical repair of the ulnar collateral ligament of the thumb metacarpophalangeal joint with K-wire immobilization: prospective case series of 21 patients.
      • Samora J.B.
      • Harris J.D.
      • Griesser M.J.
      • et al.
      Outcomes after injury to the thumb ulnar collateral ligament--a systematic review.
      Injury of the UCL is categorized into grades 1, 2, and 3, including sprains, partial tears, and complete tears, respectively, with complete tears necessitating surgical intervention.
      • Avery 3rd, D.M.
      • Inkellis E.R.
      • Carlson M.G.
      Thumb collateral ligament injuries in the athlete.
      ,
      • Katolik L.I.
      • Friedrich J.
      • Trumble T.E.
      Repair of acute ulnar collateral ligament injuries of the thumb metacarpophalangeal joint: a retrospective comparison of pull-out sutures and bone anchor techniques.
      ,
      • Madan S.S.
      • Pai D.R.
      • Kaur A.
      • et al.
      Injury to ulnar collateral ligament of thumb.
      • Kozin S.H.
      Treatment of thumb ulnar collateral ligament ruptures with the Mitek bone anchor.
      • Gerber C.
      • Senn E.
      • Matter P.
      Skier's thumb: surgical treatment of recent injuries to the ulnar collateral ligament of the thumb's metacarpophalangeal joint.
      • Venus M.R.
      • Chester D.L.
      Outcomes in repair of the ulnar collateral ligament of the thumb metacarpophalangeal joint.
      • Werner B.C.
      • Hadeed M.M.
      • Lyons M.L.
      • et al.
      Return to football and long-term clinical outcomes after thumb ulnar collateral ligament suture anchor repair in collegiate athletes.
      Primary repair is the standard surgery for acute tears, because it demonstrates favorable postoperative outcomes and low complication rates.
      • Samora J.B.
      • Harris J.D.
      • Griesser M.J.
      • et al.
      Outcomes after injury to the thumb ulnar collateral ligament--a systematic review.
      ,
      • Kozin S.H.
      Treatment of thumb ulnar collateral ligament ruptures with the Mitek bone anchor.
      • Gerber C.
      • Senn E.
      • Matter P.
      Skier's thumb: surgical treatment of recent injuries to the ulnar collateral ligament of the thumb's metacarpophalangeal joint.
      • Venus M.R.
      • Chester D.L.
      Outcomes in repair of the ulnar collateral ligament of the thumb metacarpophalangeal joint.
      ,
      • Derkash R.S.
      • Matyas J.R.
      • Weaver J.K.
      • et al.
      Acute surgical repair of the skier's thumb.
      • Weiland A.J.
      • Berner S.H.
      • Hotchkiss R.N.
      • et al.
      Repair of acute ulnar collateral ligament injuries of the thumb metacarpophalangeal joint with an intraosseous suture anchor.
      • Jackson M.
      • McQueen M.M.
      Gamekeeper's thumb: a quantitative evaluation of acute surgical repair.
      • Bostock S.
      • Morris M.A.
      The range of motion of the MP joint of the thumb following operative repair of the ulnar collateral ligament.
      This leads to questions about the role of a new technology for a seemingly successful surgery. In this paper, we conducted a model-based CEA to compare a novel ligament augmentation device to the standard technique for primary repair of the UCL to evaluate the effectiveness and cost-effectiveness of this new technology.
      • Osterman A.L.
      • Hayken G.D.
      • Bora Jr., F.W.
      A quantitative evaluation of thumb function after ulnar collateral repair and reconstruction.

      Materials and Methods

      Overview

      Our model was developed using TreeAge Pro 2018 software (TreeAge Software), and we analyzed operative treatment options for patients with complete UCL tears. This model compared the cost-effectiveness of the standard technique to device-assisted ligament augmentation repair. Due to the acute nature of UCL tears and the limited data on long-term follow-up after primary repair, a time horizon of 1 year was chosen. A societal perspective was used, accounting for costs to the health care payer (Ontario Ministry of Health and Long Term Care), such as the surgical procedure, postoperative care, and productivity loss due to sick leave. Clinical outcomes included the incidence of a complication and probability of a good or bad outcome. A complication was defined as a deep surgical site infection (SSI). A bad outcome was defined as laxity >30° at 3-month postoperative evaluation.
      • Avery 3rd, D.M.
      • Inkellis E.R.
      • Carlson M.G.
      Thumb collateral ligament injuries in the athlete.
      ,
      • Osterman A.L.
      • Hayken G.D.
      • Bora Jr., F.W.
      A quantitative evaluation of thumb function after ulnar collateral repair and reconstruction.
      In contrast, a good outcome was defined as postoperative laxity <30° on valgus stress testing. Cost-effectiveness outcomes included (1) quality-adjusted life years (QALYs), defined as a year of life adjusted for its quality or value; (2) costs in 2018 Canadian Dollars; (3) net monetary benefit (NMB), a summary statistic representing the monetary value of an intervention when a willingness-to-pay threshold for a QALY was available (cost-effectiveness threshold of CAD $50,000/QALY gained assumed); and (4) incremental net monetary benefit (INMB).

      Model structure

      Two treatment strategies were included for primary repair of the ligament: (1) device-assisted and (2) standard technique. Following primary repair of the ligament, patients could experience a good (laxity < 30°) or bad (laxity > 30°) outcome. Individuals who had a good outcome at any point in the model required no further intervention, whereas a proportion of patients who experienced a bad outcome subsequently received surgery to correct the resultant laxity (> 30°) of the MCPJ. To evaluate the cost-effectiveness of both treatment arms, individuals in the model had to complete the treatment course to which they were assigned; thus, 80% was assumed to undergo surgery to correct persistent laxity. Throughout the model, patients in either treatment group could develop a complication (deep SSI), which was assumed to lead to higher rates of bad outcomes (Figure 1, Figure 2).
      Figure thumbnail gr1
      Figure 1Model schematic for acute primary repair of complete ulnar collateral ligament tear.
      Figure thumbnail gr2
      Figure 2Decision tree with utility values and QALYs.

      Model assumptions

      Several assumptions were made. First, we modeled only severe complications, such as deep SSI, which required all patients to undergo further treatment.
      Canadian Institute for Health Information
      Canadian Patient Safety Institute.
      SSI was the only complication modeled because it was assumed to vary between methods due to the introduction of a foreign body (suture tape).
      • Neault M.A.
      • Nuber G.W.
      • Marymont J.V.
      Infections after surgical repair of acromioclavicular separations with nonabsorbable tape or suture.
      • Schumpelick V.
      • Klinge U.
      • Rosch R.
      • et al.
      Light weight meshes in incisional hernia repair.
      • Hanna M.
      • Dissanaike S.
      Mesh ingrowth with concomitant bacterial infection resulting in inability to explant: a failure of mesh salvage.
      • Shin S.S.
      • van Eck C.F.
      • Uquillas C.
      Suture tape augmentation of the thumb ulnar collateral ligament repair: a biomechanical study.
      • Lubowitz J.H.
      • MacKay G.
      • Gilmer B.
      Knee medial collateral ligament and posteromedial corner anatomic repair with internal bracing.
      Second, the probability of undergoing reoperation following a bad outcome was assigned a value of 0.80; we estimated that this proportion of patients would have an outcome severe enough to require intervention based on the senior author’s clinical experience. Third, we assumed that a postoperative complication resulted in an increased probability of a bad outcome (relative risk, 1.5). Fourth, when an individual returned to work, it was assumed that they returned to preinjury functioning and activities, and time off work was not associated with a decreased quality of life.

      Data

      Probabilities

      We conducted a comprehensive literature review searching PubMed, MEDLINE (1946 to present), and Embase (1947 to June 21, 2018) databases to obtain data informing postoperative outcomes. Search terms included “ulnar collateral ligament,” “surgical,” and “operative.” Of the 851 papers identified, 21 papers met the inclusion criteria of clinical trials and observational studies documenting postoperative outcomes following acute surgical repair of complete UCL tears. All were retrospective or prospective cohort studies. An average of the probability of complications and bad outcomes from individual studies was calculated to obtain a mean probability of .016 and .006, respectively (Table 1).
      • Sourmelis S.V.
      Repair of the ulnar collateral ligament of the thumb.
      • Chuter G.S.
      • Muwanga C.L.
      • Irwin L.R.
      Ulnar collateral ligament injuries of the thumb: 10 years of surgical experience.
      • Engelhardt J.B.
      • Christensen O.M.
      • Christiansen T.G.
      Rupture of the ulnar collateral ligament of the metacarpophalangeal joint of the thumb.
      • Wilppula E.
      • Nummi J.
      Surgical treatment of ruptured ulnar collateral ligament of the metacarpophalangeal joint of the thumb.
      Table 1Probability of Outcomes Included in the Model
      VariableBaseline ProbabilitiesAssumptionsReferences
      Probability of complication.016
      Baseline probabilities are the mean of estimates from published studies, which utilize various techniques to primarily repair complete UCL tears.
      Complication defined as infection; probability of complication hypothesized to be greater when using the InternalBrace due to insertion of the suture tape
      .00Gerber et al, 1981
      • Gerber C.
      • Senn E.
      • Matter P.
      Skier's thumb: surgical treatment of recent injuries to the ulnar collateral ligament of the thumb's metacarpophalangeal joint.
      .00Weiland et al, 1997
      • Weiland A.J.
      • Berner S.H.
      • Hotchkiss R.N.
      • et al.
      Repair of acute ulnar collateral ligament injuries of the thumb metacarpophalangeal joint with an intraosseous suture anchor.
      .00Werner et al, 2014
      • Werner B.C.
      • Hadeed M.M.
      • Lyons M.L.
      • et al.
      Return to football and long-term clinical outcomes after thumb ulnar collateral ligament suture anchor repair in collegiate athletes.
      .00Sourmelis, 1997
      • Sourmelis S.V.
      Repair of the ulnar collateral ligament of the thumb.
      .02Chuter et al, 2009
      • Chuter G.S.
      • Muwanga C.L.
      • Irwin L.R.
      Ulnar collateral ligament injuries of the thumb: 10 years of surgical experience.
      .02Venus and Chester, 2012
      • Venus M.R.
      • Chester D.L.
      Outcomes in repair of the ulnar collateral ligament of the thumb metacarpophalangeal joint.
      .07Engelhardt et al, 1993
      • Engelhardt J.B.
      • Christensen O.M.
      • Christiansen T.G.
      Rupture of the ulnar collateral ligament of the metacarpophalangeal joint of the thumb.
      Probability of bad outcome.006
      Baseline probabilities are the mean of estimates from published studies, which utilize various techniques to primarily repair complete UCL tears.
      Bad outcome defined as laxity > 30°; baseline probability of bad outcome assumed to be the same between treatment arms
      .00Jackson and McQueen, 1994
      • Jackson M.
      • McQueen M.M.
      Gamekeeper's thumb: a quantitative evaluation of acute surgical repair.
      .00Bostock and Morris, 1993
      • Bostock S.
      • Morris M.A.
      The range of motion of the MP joint of the thumb following operative repair of the ulnar collateral ligament.
      .00Osterman et al, 1981
      • Osterman A.L.
      • Hayken G.D.
      • Bora Jr., F.W.
      A quantitative evaluation of thumb function after ulnar collateral repair and reconstruction.
      .00Sourmelis, 1997
      • Sourmelis S.V.
      Repair of the ulnar collateral ligament of the thumb.
      .03Wilppula and Nummi, 1970
      • Wilppula E.
      • Nummi J.
      Surgical treatment of ruptured ulnar collateral ligament of the metacarpophalangeal joint of the thumb.
      Probability of bad outcome after complication.009Relative Risk of 1.5 associated with a complication in the model, therefore increased probability of bad outcome following infectionBased on senior author’s judgment and clinical experience
      Probability of bad outcome after re-operation.012Relative Risk of 2.0 associated with re-operation in the model, therefore increased probability of bad outcome following re-operationBased on senior author’s judgment and clinical experience
      Probability of treatment following initial bad outcome.80Most individuals with significant laxity will choose to undergo re-operation to increase stability of the ligamentBased on senior author’s clinical experience
      Baseline probabilities are the mean of estimates from published studies, which utilize various techniques to primarily repair complete UCL tears.

      Health state utility values

      As there was no published literature on the utility values for UCL injuries, we determined the utility of a complete UCL tear using the time trade-off (TTO) method. A utility is a quantitative value assigned to a health state on a scale of 0 (death) to 1 (perfect health) to represent the quality of life in a particular health state.
      • Li Y.K.
      • Alolabi N.
      • Kaur M.N.
      • et al.
      A systematic review of utilities in hand surgery literature.
      ,
      • Thoma A.
      • McKnight L.L.
      Quality-adjusted life-year as a surgical outcome measure: a primer for plastic surgeons.
      TTO was a direct utility measurement tool that provided participants with the choice of living X years in a perfect health state or T years with a complete UCL tear. The utility value could then be calculated as X/T.
      • Chung K.C.
      • Oda T.
      • Saddawi-Konefka D.
      • et al.
      An economic analysis of hand transplantation in the United States.
      After approval from our institutional research ethics board, 33 (15 male, 17 female, 1 unspecified) volunteers without a history of UCL-related injuries were surveyed. The mean age of respondents was 47 (SD + 20) years, and the majority were right-hand dominant (91%). Individuals completed a TTO survey (Appendix E1, available online on the Journal’s website at www.jhandsurg.org), which assessed the utility value of a complete UCL tear for both the dominant and nondominant hands, providing a mean value of 0.95 (SD ± 0.06) and 0.96 (SD ± 0.05), respectively. A utility value of 0.95 was used in our model to denote a complete UCL tear, as the majority of injuries documented in the literature affected the dominant hand.
      • Samora J.B.
      • Harris J.D.
      • Griesser M.J.
      • et al.
      Outcomes after injury to the thumb ulnar collateral ligament--a systematic review.
      ,
      • Jackson M.
      • McQueen M.M.
      Gamekeeper's thumb: a quantitative evaluation of acute surgical repair.
      This value was similar to the published literature on upper extremity injuries/disability.
      • Graham B.
      • Detsky A.S.
      The application of decision analysis to the surgical treatment of early osteoarthritis of the wrist.
      When patients developed a complication, had a bad outcome, or underwent a reoperation, a utility value of 0.05 was subtracted from the patient’s current utility value/health state. For patients who experienced a good outcome, a utility value of 0.03 was added to the patient’s current utility value/health state (Table 2). These values were determined based on similar utilities in the hand surgery literature.
      • Cavaliere C.M.
      • Chung K.C.
      A cost-utility analysis of nonsurgical management, total wrist arthroplasty, and total wrist arthrodesis in rheumatoid arthritis.
      • Baltzer H.
      • Binhammer P.A.
      Cost-effectiveness in the management of Dupuytren's contracture. A Canadian cost-utility analysis of current and future management strategies.
      • Chen N.C.
      • Shauver M.J.
      • Chung K.C.
      Cost-effectiveness of open partial fasciectomy, needle aponeurotomy, and collagenase injection for dupuytren contracture.
      Table 2Utility Values for Health States Included in the Model
      Health StateBaseline Utility
      Utilities
      Complete ulnar collateral ligament tear0.95
      Good outcome following treatment or reoperation0.03
      Complication necessitating treatment0.05
      Reoperation0.05
      Bad outcome following primary surgery, complication, or treatment0.05

      Costs

      Cost calculations reflected the societal perspective, including patient and health care–incurred costs. All costs were reported in 2018 Canadian dollars (Table 3).
      Table 3Cost Estimates Included in the Model
      VariableTotal Cost, CAD $Assumptions
      Initial operation—standard technique$2542.87Total cost estimate includes surgeon, anesthesia, and hospital fees
      Initial operation—Arthrex InternalBrace$3,322.87Total cost estimate includes surgeon, anesthesia, hospital, and device fees (CAD $780)
      Reoperation following bad outcome$4,669.55Anesthesia time and hospital fees adjusted due to increased time of procedure and/or utilization
      Complication—oral antibiotics$53.57Cost calculated based on price of oral cephalexin 500 mg three times daily × 4 weeks (84 tablets)
      Complication—IV antibiotics$1,113.51Cost of medication calculated based on price of IV cefazolin 1g every 8 hours × 2 weeks (42 vials); IV antibiotics administered on an outpatient basis with daily in-home nursing care (nursing fees included in total cost)
      Complication—supplies for IV antibiotic administration$290.17IV antibiotics administered via peripheral intravenous catheter using 5mL 21G Luer-Lok Tip Syringe
      Complication—surgical debridement/removal of internal fixation device$2,280.15Surgeon, anesthesia, and hospital fees included in total cost estimate; hospital fees assumed to be equivalent to those of initial operation
      Time off work following initial surgery and reoperation$5,207.20Individuals work a standard 8-hour workday; for re-operation, laxity assumed to not significantly affect return to work
      IV, intravenous.
      Physician services. The surgeon and anesthesia fee schedules were obtained from the Ontario Health Insurance Program (OHIP) Schedule of Benefits.
      Ontario Ministry of Health Ministry of Long-Term Care
      Ontario Health Insurance Plan: OHIP Schedule of Benefits and Fees.
      In calculating the anesthesia fee, we used the time units allocated for the procedure and the cost for a brachial plexus block. The combined cost of the surgeon and anesthesia fees for initial operation was CAD $565.87 for both standard and device-assisted methods. The cost of physician services for reoperation due to bad outcome was CAD $715.55 due to the increased complexity of a secondary procedure where the ligament was reconstructed with a tendon graft, and bone holes in both the metacarpal and proximal phalanx were required (Table E1, available online on the Journal’s website at www.jhandsurg.org).
      • Maneaud M.
      • Littler J.W.
      Reconstruction of the ulnar metacarpo-phalangeal ligament of the thumb.
      Hospital costs. Hospital costs were obtained through the Sunnybrook Health Sciences Centre (SHSC) financial department. Initial operation hospital fees were CAD $1,977.00. The cost of the Ligament Augmentation Repair Convenience Kit (CAD $780.00) was obtained from a Canadian sales representative (A. Martins, personal communication, July 23, 2018) (Table E1).
      Treatment of complication and reoperation. The cost of treatment for a complication was CAD $3,737.40, which assumed the SSI was severe and required surgical debridement, intravenous antibiotics for a period of 2 weeks, and oral antibiotics for 4 weeks. The costs of oral and intravenous antibiotics were gathered from the SHSC pharmacy, and the cost of surgical debridement was estimated from the OHIP Schedule of Benefits (Table E2, available online on the Journal’s website at www.jhandsurg.org).
      Ontario Ministry of Health Ministry of Long-Term Care
      Ontario Health Insurance Plan: OHIP Schedule of Benefits and Fees.
      The total cost of reoperation was CAD $4,669.55, which accounted for ligamentous reconstruction with tendon graft and reflected the OHIP billing code for standard ligamentous repair and separate incision for graft harvesting (Table E1).
      Productivity loss. The cost of productivity loss due to surgery was estimated using Statistics Canada 2017 region-specific income data for individuals working full-time in Ontario.
      Statistics Canada
      Average full-time hourly wage paid and payroll employment by type of work, economic region and occupation.
      Based on data from Picard et al
      • Picard F.
      • Khalifa H.
      • Dubert T.
      Duration of sick leave after surgical repair of the ulnar collateral ligament of the thumb metacarpophalangeal joint with K-wire immobilization: prospective case series of 21 patients.
      (Table E3, available online on the Journal’s website at www.jhandsurg.org), all patients were assumed to return to work after 23 days. The difference in time off work was defined as the number of days earlier one could return to work using the ligament augmentation device versus standard repair. Total productivity loss cost was CAD $5,207.20. Productivity loss was the only patient-incurred cost that we chose to model, because this encompassed all major costs incurred by patients following surgery.

      Analysis

      Base case

      The model base case was a predominantly male population, aged 34 years,
      • Gerber C.
      • Senn E.
      • Matter P.
      Skier's thumb: surgical treatment of recent injuries to the ulnar collateral ligament of the thumb's metacarpophalangeal joint.
      ,
      • Jackson M.
      • McQueen M.M.
      Gamekeeper's thumb: a quantitative evaluation of acute surgical repair.
      with an acute (<4 weeks) complete UCL tear of the thumb MCPJ.

      Cost-effectiveness analysis

      Our analysis determined the expected QALYs and costs for both surgical interventions. Outcomes included QALYs, cost, NMB, and INMB.
      NMB=(QALY×λ)Cost


      Where λ represented the cost-effectiveness threshold, set at the commonly used threshold of CAD $50,000/QALY in our analysis.
      • Ryder H.F.
      • McDonough C.
      • Tosteson A.N.
      • et al.
      Decision analysis and cost-effectiveness analysis.
      ,
      • Chung K.C.
      • Oda T.
      • Saddawi-Konefka D.
      • et al.
      An economic analysis of hand transplantation in the United States.
      The INMB was determined by calculating the difference in absolute NMB between techniques.
      INMB=|NMB(standard)NMB(InternalBrace)|


      Model validation

      Face validity of our model was ensured by reviewing the model structure, data sources, and results.
      • Eddy D.M.
      • Hollingworth W.
      • Caro J.J.
      • et al.
      Model transparency and validation: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force--7.
      Internal validity was tested using extensive bivariate sensitivity analyses (SAs). We could not assess cross-validity, because there were no existing models comparing standard technique and device-assisted repair.
      • Eddy D.M.
      • Hollingworth W.
      • Caro J.J.
      • et al.
      Model transparency and validation: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force--7.
      External validity of the model was not assessed, as all available data were included in the model.

      Sensitivity analyses

      Using one-way SA, we varied complication rate, probability of bad outcome, cost of the device, and difference in time off work and days off work, because they were subject to change based on technique. One-way SA were performed to assess the effect of changes to these variables on NMB and to determine threshold values at which the device became the favored strategy. Two-way SA were performed to evaluate the preferred strategy when simultaneously modifying the values for cost of the device and days off work, and to evaluate the probability of postoperative complication and cost of the device. These scenarios had important implications for patients, physicians, and health care expenditure.

      Results

      Base case analysis

      QALYs were the same for the standard technique and device-assisted repair (0.98 QALYs), as utility values and probabilities for the 2 treatments were assumed to be identical in the base case. The standard technique was preferable to device-assisted ligament augmentation repair with regards to cost and NMB (Table 4).
      Table 4Cost-Effectiveness Model Outcomes (CAD $)
      QALYCostNMB
      InternalBrace0.98$7,124.69$41,818.14
      Standard technique0.98$6, 344.69$42,598.14
      The NMB was computed for the standard technique (CAD $42,598) and device-assisted repair (CAD $41,818), with an INMB of CAD $780. The greater NMB value indicated that the standard technique was a more cost-effective option, thus it was favored for our base case.
      • Messori A.
      • Trippoli S.
      The results of a pharmacoeconomic study: incremental cost-effectiveness ratio versus net monetary benefit.

      One-way sensitivity analyses

      One-way SA demonstrated no threshold values for incidence of complication (Fig. E1, A, available online on the Journal’s website at www.jhandsurg.org), probability of bad outcome (Fig. E1, B), and cost of the device (Fig. E2, A, available online on the Journal’s website at www.jhandsurg.org), with the standard technique remaining the most cost-effective strategy at plausible ranges for each of these variables.
      However, our analysis was sensitive to time off work. When varying time off work between 0 and 30 days (base case set at 23 days), the device-assisted ligament augmentation repair became the favored option when individuals were able to return to work 5 days earlier than the base case (Fig. E2, B).

      Two-way sensitivity analyses

      Using 2-way SA, the cost of the device was varied between CAD $0 and CAD $1,000, and the difference in time off work of the device-assisted repair relative to the standard technique was varied between 0 and 10 days. When the cost of the device was decreased to CAD $50 and the difference in time off work was increased to 1 day, the device became the preferred strategy (Fig. 3).
      Figure thumbnail gr3
      Figure 3Two-way sensitivity analyses for cost of device-assisted ligament augmentation versus difference in time off work (in days).
      Probability of complication and cost of the ligament augmentation device were also varied in 2-way SA with the complication rate varied between clinically plausible ranges of 0 and 0.05 and cost of the device varied between CAD $0 and CAD $1,000. As the cost of the device was varied between CAD $0 and CAD $100, it was the preferred strategy between a complication rate of 0 to 0.01. However, when the device cost was increased above CAD $100, regardless of the probability of complication, the standard technique was favored. Similarly, when the probability of complication was increased above 0.016, the standard technique was favored, regardless of the cost of the ligament augmentation device (Fig. 4).
      Figure thumbnail gr4
      Figure 4Two-way sensitivity analyses for cost of device versus probability of complication with ligament augmentation repair.

      Discussion

      Model-based CEA uses decision analysis to compare the expected costs of treatment alternatives, and it identifies what treatments provide the maximal health benefit for a given cost.
      • Ryder H.F.
      • McDonough C.
      • Tosteson A.N.
      • et al.
      Decision analysis and cost-effectiveness analysis.
      Increasing demands on the health care system with an emphasis on prudent resource utilization has resulted in CEA, as well as HTA, playing an integral role in determining funding and policy decisions.
      • Sher D.J.
      • Punglia R.S.
      Decision analysis and cost-effectiveness analysis for comparative effectiveness research--a primer.
      ,
      • Ryder H.F.
      • McDonough C.
      • Tosteson A.N.
      • et al.
      Decision analysis and cost-effectiveness analysis.
      Our study provides an example of how clinicians can use model-based CEA to determine the cost-effectiveness of novel health technology and evaluate an important component of HTA.
      • Baltzer H.
      • Binhammer P.A.
      Cost-effectiveness in the management of Dupuytren's contracture. A Canadian cost-utility analysis of current and future management strategies.
      Our model shows that the introduction of a costly device for a surgery with low baseline complication rates and good clinical outcomes is generally not cost-effective. We demonstrate that the traditional option for UCL treatment is favored unless the novel device reduces time off work. In fact, our results suggest that a reduction in time off work of more than 5 days renders the device a more cost-effective strategy than the standard technique. Additionally, we found that ligament augmentation repair is preferred if patients can return to work in 22 days, when the cost of the device is less than CAD $50. This is an improbable scenario in clinical practice, especially in a privatized health care system such as that in the United States, thereby making the conditions under which the device becomes cost-effective less likely. These findings, however, demonstrate the substantial impact of time off work on NMB and the importance of selecting a societal perspective for our analysis. We have noted that as the difference in time off work between the two techniques increases, the high cost of the device can be absorbed. Thus, we infer that time off work poses a significant cost to society and can mitigate the high cost associated with the introduction of a novel technology. Our choice of selecting a societal perspective allows for the identification of the impact of time off work on costs of a new technology. In accordance with the Panel on Cost-Effectiveness in Health and Medicine, we suggest that future research include a societal perspective when conducting CEA to identify costs that can greatly affect whether a device is considered cost-effective.
      • Cavaliere C.M.
      • Chung K.C.
      A cost-utility analysis of nonsurgical management, total wrist arthroplasty, and total wrist arthrodesis in rheumatoid arthritis.
      It is evident that an earlier return to work benefits both the patient and society at large; however, there are no published cohort studies that clearly demonstrate an expedited return to work with use of a ligament augmentation device. De Giacomo and Shin
      • De Giacomo A.F.
      • Shin S.S.
      Repair of the thumb ulnar collateral ligament with suture tape augmentation.
      published a case report documenting their experience with its use in a professional athlete and reported a return to play 5.3 weeks postoperatively. The authors asserted that UCL repair with suture tape ligament augmentation provided immediate biomechanical strength and support facilitating “an earlier return to activities, work or play.”
      • De Giacomo A.F.
      • Shin S.S.
      Repair of the thumb ulnar collateral ligament with suture tape augmentation.
      Despite their promising results, larger cohort studies documenting results in multiple patients of various occupations must be undertaken to generalize these findings to a broader patient population. Furthermore, studies that specifically demonstrate a reduction in time off work must be published before we can infer that a device will consistently produce a faster-healing repair. Our findings also support the need for increased reporting of return to work in the literature, because few studies currently exist that examine this outcome.
      • Picard F.
      • Khalifa H.
      • Dubert T.
      Duration of sick leave after surgical repair of the ulnar collateral ligament of the thumb metacarpophalangeal joint with K-wire immobilization: prospective case series of 21 patients.
      ,
      • Moharram A.N.
      Repair of thumb metacarpophalangeal joint ulnar collateral ligament injuries with microanchors.
      ,
      • Rocchi L.
      • Merolli A.
      • Morini A.
      • Monteleone G.
      • Foti C.
      A modified spica-splint in postoperative early-motion management of skier's thumb lesion: a randomized clinical trial.
      Although we can determine the parameters under which the novel device is cost-effective, we acknowledge that our study has limitations. Due to limited published data regarding device-assisted ligament augmentation and UCL injuries, we have been required to make various assumptions, specifically with regard to postoperative health state utility values and the probability of outcomes following complication and reoperation. These assumptions, however, are an inherent and necessary component of CEA models.
      • Kotsis S.V.
      • Chung K.C.
      Fundamental principles of conducting a surgery economic analysis study.
      Additionally, because the impact on operative duration is unknown, costs for primary repair and re-operation do not take into account increased operative time, which may be present with use of a novel device.
      Using model-based CEA, we have identified scenarios in which the novel ligament augmentation device is the more cost-effective option compared to the standard technique. It must also be noted that, although the costs in our model appear low in comparison to those reported in the American literature, it is not the cost itself that determines cost-effectiveness but rather the relative utility values and associated probabilities.
      Cost-effectiveness and clinical efficacy comprise only part of a larger, systematic process that must be undertaken prior to implementation of novel health technology. Physicians and their associated hospitals must also conduct a thorough review of the technology’s safety, consider the ethics of its use, as well as the technical properties and logistical components of the technology in question.
      • Goodman C.S.
      Fundamental concepts.
      The increasing speed with which novel technologies are introduced, in conjunction with an increasing focus on value for cost, requires physicians to have an understanding of HTA and CEA. Our study provides an example for clinicians to follow to evaluate the efficacy and cost-effectiveness of novel technologies so that physicians can make informed, conscientious decisions that are clinically and economically beneficial for their practice.

      Appendix E1: Time Trade-Off Survey

      The time trade-off will be employed through a structured questionnaire shown below:
      Imagine you are 34 years old and have suffered an injury to your thumb. You have tenderness, swelling and bruising, as well as a feeling of “looseness” in your thumb. This impairs your ability to grip and pinch. It affects activities of daily living, work, sporting activities such as throwing a ball or grasping a racquet, using tools, writing, opening jars, turning a key, and pinching small objects between your thumb and fingers. You are otherwise physically and mentally healthy, and your injury has no significant impact on your social life or relationships.
      Imagine living the remainder of your natural lifespan (additional 45 years) in your present state. Contrast this with the alternative that you can return to perfect health for fewer years. How many years of your life would you be willing to trade in order to live in perfect health?E.g. John is 34 years old and has an additional 45 years of life remaining. He would be willing to trade 2 years of life to live in perfect health. This means that he would be willing to live 2 years shorter in order to live for 43 years without the symptoms of his thumb injury.
      Tabled 1How Many Years of Life Would You be Willing to Trade to Live with a Normal Thumb if Your Dominant Thumb was Affected? (Please Circle Only One Option):
      1. 0 years9. 4 years17. 8 years
      2. 0.5 years10. 4.5 Years18. 8.5 years
      3. 1 year11. 5 Years19. 9 years
      4. 1.5 years12. 5.5 Years
      5. 2 years13. 6 Years
      6. 2.5 years14. 6.5 Years
      7. 3 years15. 7 Years
      8. 3.5 years16. 7.5 Years
      I would trade _______ year(s) of life to live with a normal DOMINANT thumb without any thumb injury symptoms.
      Tabled 1How Many Years of Life Would You be Willing to Trade to Live with a Normal Thumb if Your Nondominant Thumb was Affected? (Please Circle Only One Option):
      1. 0 years9. 4 years17. 8 years
      2. 0.5 years10. 4.5 Years18. 8.5 years
      3. 1 year11. 5 Years19. 9 years
      4. 1.5 years12. 5.5 Years
      5. 2 years13. 6 Years
      6. 2.5 years14. 6.5 Years
      7. 3 years15. 7 Years
      8. 3.5 years16. 7.5 Years
      I would trade _______ year(s) of life to live with a normal NONDOMINANT thumb without any thumb injury symptoms.
      Table E1Cost Estimates for Surgical Procedures (CAD $)
      ProcedureSurgical Code
      Surgical code determined based on Ontario Health Insurance Program (OHIP) Schedule of Benefits for Musculoskeletal System Surgical Procedures.37
      Surgeon Fee
      Surgeon’s fee determined based on the Ontario Health Insurance Program (OHIP) Schedule of Benefits37 billing codes #R601(ligament-metacarpal phalangeal repair) and #E551 (single incision).
      Anesthesia Fee
      Anesthesia fee calculated based on 7 units as outlined in the Ontario Health Insurance Program (OHIP) Schedule of Benefits37 for billing code #R601, current cost of anesthesia unit ($15.00), cost of plexus block ($80) and average anesthesia time (64 minutes).
      Device FeeHospital Fee
      Hospital fee includes operating room labor, patient specific supplies, operating room materials, building and grounds fees, as well as day surgery and respiratory therapy costs; data based on standard primary repair (time and resource use), and was obtained through the institution’s financial department.
      Assumptions/ CalculationsTotal Cost
      Initial operation: standard techniqueLigaments-metacarpal phalangeal repair$316.75$249.12N/A$1,977.00$316.75 + $249.12 + $1,977.00$2,542.87
      Initial operation: Arthrex InternalBrace
      Hospital fee includes operating room labor, patient-specific supplies, operating room materials, building and grounds fees, and day surgery and respiratory therapy costs; data based on standard primary repair (time and resource use), and was obtained through the institution’s financial department.
      Ligaments-metacarpal phalangeal repair$316.75$249.12$780.00$1,977.00$316.75+ $249.12 + $1,977.00 + $780.00$3,322.87
      Re-oeration following bad outcomeLigaments- metacarpal phalangeal repair and separate incision$403.05
      Surgeon fee includes cost for standard ligament repair, as well as that for separate incision (#E551-$86.30) due to increased complexity of secondary operation.
      $312.50N/A$3, 954.00Anesthesia time and hospital fees doubled due to increased time of procedure and operating room use (assumed to be twice as long as initial operation as reconstruction included harvesting of tendon graft)$4,669.55
      Surgical code determined based on Ontario Health Insurance Program (OHIP) Schedule of Benefits for Musculoskeletal System Surgical Procedures.
      Ontario Ministry of Health Ministry of Long-Term Care
      Ontario Health Insurance Plan: OHIP Schedule of Benefits and Fees.
      Surgeon’s fee determined based on the Ontario Health Insurance Program (OHIP) Schedule of Benefits
      Ontario Ministry of Health Ministry of Long-Term Care
      Ontario Health Insurance Plan: OHIP Schedule of Benefits and Fees.
      billing codes #R601(ligament-metacarpal phalangeal repair) and #E551 (single incision).
      Anesthesia fee calculated based on 7 units as outlined in the Ontario Health Insurance Program (OHIP) Schedule of Benefits
      Ontario Ministry of Health Ministry of Long-Term Care
      Ontario Health Insurance Plan: OHIP Schedule of Benefits and Fees.
      for billing code #R601, current cost of anesthesia unit ($15.00), cost of plexus block ($80) and average anesthesia time (64 minutes).
      § Hospital fee includes operating room labor, patient specific supplies, operating room materials, building and grounds fees, as well as day surgery and respiratory therapy costs; data based on standard primary repair (time and resource use), and was obtained through the institution’s financial department.
      ¥ Cost of InternalBrace ($780.00) manufactured by Arthrex obtained via company representative for geographical region (A. Martins, personal communication, July 23, 2018); operation with InternalBrace assumed to have identical costs as initial operation, other than the cost of the device.
      ∗∗ Surgeon fee includes cost for standard ligament repair, as well as that for separate incision (#E551-$86.30) due to increased complexity of secondary operation.
      Table E2Cost Estimates for Complication (CAD $)
      ComplicationMarket Value Cost
      Market value cost of medication retrieved from Sunnybrook Health Sciences Centre Pharmacy.
      Pharmacy Fee
      Pharmacy fee is the Sunnybrook Health Centre Pharmacy dispensing fee; the assumption was made that all patients requiring treatment for a complication would obtain medication from the institution’s pharmacy and would not be eligible for additional Ontario Drug Benefit coverage.
      Nursing Fees
      Nursing fees calculated assuming an average nursing time of 1 hour per day for 14 days (time required for teaching, management of IV devices and assessment of infection, etc.) at an hourly salary of $58.88, which includes salary and benefits (Stiver HG, Telford GO, Mossey JM, et al. Intravenous antibiotic therapy at home. Ann Intern Med., 1978;89(5 Pt 1):690-693; Health Quality Ontario. Home-based subcutaneous infusion of immunoglobulin for primary and secondary immunodeficiencies: a health technology assessment. Ont Health Technol Assess Ser. 2017;17(16):1-86.).
      Total CostCalculations/Assumptions
      Oral antibiotics$41.58$11.99N/A$53.57Cost calculated based on price of oral cephalexin 500 mg 3 times daily × 4 weeks (84 tablets)
      Intravenous (IV) antibiotics$277.20$11.99$824.32$1,113.51Cost of medication calculated based on price of IV cefazolin 1g every 8 hours × 2 weeks (42 vials); IV antibiotics administered on an outpatient basis with daily in-home nursing care
      Supplies for IV antibiotic administration$290.17
      Cost of supplies retrieved from Sunnybrook Health Sciences Centre Pharmacy; assumption that IV antibiotics are administered via 21G peripheral cannula and are re-sited every 3 days is based on correspondence with pharmacy personnel, Sunnybrook intravenous antibiotic therapy (IVAT) clinic, as well as Laupland et al. study that cites the same clinical practice (Laupland KB, Gill MJ, Schenk L, et al., Outpatient parenteral antibiotic therapy: evolution of the Calgary adult home parenteral therapy program. Clin Invest Med.. 2002;25(5):185-190.). Cost calculation includes the following: 5 primary tubing sets ($11.05 x 5 = $55.25), 42 polyamps ($1.99 x 42 = $83.58), alcohol swabs (box of 200 for $4.95), gloves (box of 100 for $11.99), 42 5 mL 21G 1½” Luer-Lok Tip syringes ($0.20 x 42 = $8.40), and 42 Sodium Chloride 0.9% 100 mL mini-bag ($3.00 x 42 = $126.00).
      N/AN/A$290.17IV antibiotics administered via peripheral intravenous catheter using 5mL 21G Luer-Lok Tip Syringe
      Complication/Surgical Code
      Surgical code determined based on Ontario Health Insurance Program (OHIP) Schedule of Benefits for Musculoskeletal System Surgical Procedures.37
      Surgeon Fee
      Surgeon’s fee determined based on the Ontario Health Insurance Program (OHIP) Schedule of Benefits37 billing code #R267 (removal of internal fixation device).
      Anesthesia Fee
      Anesthesia fee calculated based on 6 units as outlined in the Ontario Health Insurance Program (OHIP) Schedule of Benefits37 for billing code #R267, current cost of anesthesia unit ($15.00), cost of plexus block ($80) and average anesthesia time (64 minutes).
      Hospital Fee
      Cost of InternalBrace ($780.00) manufactured by Arthrex obtained via company representative for geographical region (A. Martins, personal communication, July 23, 2018); operation with InternalBrace assumed to have identical costs as initial operation, other than the cost of the device.
      Total CostCalculations/Assumptions
      Surgical debridement/removal of internal fixation device$158.65$144.50$1, 977.00$2, 280.15Hospital fees assumed to be equivalent to those of initial operation
      Market value cost of medication retrieved from Sunnybrook Health Sciences Centre Pharmacy.
      Pharmacy fee is the Sunnybrook Health Centre Pharmacy dispensing fee; the assumption was made that all patients requiring treatment for a complication would obtain medication from the institution’s pharmacy and would not be eligible for additional Ontario Drug Benefit coverage.
      Nursing fees calculated assuming an average nursing time of 1 hour per day for 14 days (time required for teaching, management of IV devices and assessment of infection, etc.) at an hourly salary of $58.88, which includes salary and benefits (Stiver HG, Telford GO, Mossey JM, et al. Intravenous antibiotic therapy at home. Ann Intern Med., 1978;89(5 Pt 1):690-693; Health Quality Ontario. Home-based subcutaneous infusion of immunoglobulin for primary and secondary immunodeficiencies: a health technology assessment. Ont Health Technol Assess Ser. 2017;17(16):1-86.).
      ∗∗ Cost of supplies retrieved from Sunnybrook Health Sciences Centre Pharmacy; assumption that IV antibiotics are administered via 21G peripheral cannula and are re-sited every 3 days is based on correspondence with pharmacy personnel, Sunnybrook intravenous antibiotic therapy (IVAT) clinic, as well as Laupland et al. study that cites the same clinical practice (Laupland KB, Gill MJ, Schenk L, et al., Outpatient parenteral antibiotic therapy: evolution of the Calgary adult home parenteral therapy program. Clin Invest Med.. 2002;25(5):185-190.). Cost calculation includes the following: 5 primary tubing sets ($11.05 x 5 = $55.25), 42 polyamps ($1.99 x 42 = $83.58), alcohol swabs (box of 200 for $4.95), gloves (box of 100 for $11.99), 42 5 mL 21G 1½” Luer-Lok Tip syringes ($0.20 x 42 = $8.40), and 42 Sodium Chloride 0.9% 100 mL mini-bag ($3.00 x 42 = $126.00).
      § Surgical code determined based on Ontario Health Insurance Program (OHIP) Schedule of Benefits for Musculoskeletal System Surgical Procedures.
      Ontario Ministry of Health Ministry of Long-Term Care
      Ontario Health Insurance Plan: OHIP Schedule of Benefits and Fees.
      # Surgeon’s fee determined based on the Ontario Health Insurance Program (OHIP) Schedule of Benefits
      Ontario Ministry of Health Ministry of Long-Term Care
      Ontario Health Insurance Plan: OHIP Schedule of Benefits and Fees.
      billing code #R267 (removal of internal fixation device).
      £ Anesthesia fee calculated based on 6 units as outlined in the Ontario Health Insurance Program (OHIP) Schedule of Benefits
      Ontario Ministry of Health Ministry of Long-Term Care
      Ontario Health Insurance Plan: OHIP Schedule of Benefits and Fees.
      for billing code #R267, current cost of anesthesia unit ($15.00), cost of plexus block ($80) and average anesthesia time (64 minutes).
      ¥ Hospital fee includes operating room labor, patient-specific supplies, operating room materials, building and grounds fees, and day surgery and respiratory therapy costs; data based on standard primary repair (time and resource use), and was obtained through the institution’s financial department.
      Table E3Cost Estimates of Lost Wages due to Time Off Work
      VariableAverage Hourly Wage
      Average hourly wage based on the average full-time hourly salary for all occupations in Ontario in 201739
      Days Off Work
      Mean time off work calculated based on data presented in the Picard et al9 study.
      CalculationTotal Cost (CAD $)Assumptions
      Time off work following initial surgery$28.3023($28.30 x 8) x 23 days$5,207.20Individuals work a standard 8-hour work day
      Time off work following re-operation$28.3023($28.30 x 8) x 23 days$5,207.20Laxity assumed to not significantly affect return to work; therefore, time off work is 46 days due to recovery following re-operation
      Average hourly wage based on the average full-time hourly salary for all occupations in Ontario in 2017
      Statistics Canada
      Average full-time hourly wage paid and payroll employment by type of work, economic region and occupation.
      Mean time off work calculated based on data presented in the Picard et al
      • Picard F.
      • Khalifa H.
      • Dubert T.
      Duration of sick leave after surgical repair of the ulnar collateral ligament of the thumb metacarpophalangeal joint with K-wire immobilization: prospective case series of 21 patients.
      study.
      Figure thumbnail fx1
      Figure E1One-way sensitivity analysis varying probability of (A) complication and (B) bad outcome.
      Figure thumbnail fx2
      Figure E2One-way sensitivity analysis varying cost of (A) InternalBrace Augmentation Repair and (B) time off work.

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