Advertisement

Applying the Delphi Method to Define a Focus for the National Outcomes Registry for Tracking the Hand (NORTH)

Published:March 12, 2021DOI:https://doi.org/10.1016/j.jhsa.2021.01.007
      Surgical registries have provided reliable, generalizable, and applicable clinical data that have shaped many fields. Broad collection of defined data can answer clinical questions with greater numbers of patients and more ability to generalize to routine clinical care than randomized trials. National hand surgical registries exist outside the United States. Before the pursuit of a registry, the focus of such an effort must be defined to ensure that registry goals are feasible. This article presents the consensus process conducted by the American Society for Surgery of the Hand’s Registry Task Force exploring potential diagnoses for a hand registry.

      Key words

      Registries have been defined as “a system functioning in patient management or research, in which a standardized and complete dataset including associated follow-up is prospectively and systematically collected for a group of patients with a common disease or therapeutic intervention.”
      • Drolet B.C.
      • Johnson K.B.
      Categorizing the world of registries.
      The inclusion of a specific patient population, the collection of predefined standardized data, prospective longitudinal data collection, and aggregated data comparison are distinguishing characteristics of registries.
      • Drolet B.C.
      • Lorenzi N.M.
      Registries and evidence-based medicine in craniofacial and plastic surgery.
      Existing surgical registries have provided reliable, generalizable, and applicable clinical data. Implant registries for total joint arthroplasty and breast implants have proven crucial to providing postmarketing surveillance of implants.
      • Delaunay C.
      Registries in orthopaedics.
      ,
      • Wurzer P.
      • Hundeshagen G.
      • Cambiaso-Daniel J.
      • et al.
      Lessons learned from breast implant registries: a systematic review.
      Currently, the American Academy of Orthopaedic Surgeons is managing multiple orthopedic registries.
      American Academy of Orthopaedic Surgeons
      About the AAOS Registry Program.
      The National Surgical Quality Improvement Program has documented postoperative complications on a granular level. The data produced formed the basis for a robust body of literature in examining predictors of surgical complications across disciplines.
      • Maggard-Gibbons M.
      The use of report cards and outcome measurements to improve the safety of surgical care: the American College of Surgeons National Surgical Quality Improvement Program.
      Each registry is unique in its design and purpose, but the ability of registries to affect care on a large scale is undeniable.
      Several hand surgical registries exist. European state-sponsored registries established in the past decade function as broad-based data collection efforts with opt-out options.
      • Arner M.
      Developing a national quality registry for hand surgery: challenges and opportunities.
      Data collection has succeeded but substantial research output has been modest. In the United States, an unfunded grassroots registry for congenital hand deformities (Congenital Upper Limb Differences) has grown to 10 sites over several years and is maintained by 2 academic centers.
      • Bae D.S.
      • Canizares M.F.
      • Miller P.E.
      • Waters P.M.
      • Goldfarb C.A.
      Functional impact of congenital hand differences: early results from the Congenital Upper Limb Differences (CoULD) registry.
      To date, the American Society for Surgery of the Hand (ASSH) has not participated in a national registry. This article presents the process through which the ASSH considered possible topics for a registry effort.
      The Delphi process is a frequently referenced method for fostering a decision based on a structured multilevel process. In this exercise, we used the Delphi process to determine the optimal topics from a panel of experts to guide the organization of a national hand surgery registry (National Outcomes Registry for Tracking the Hand). Before this process, a registry task force had previously convened for several months to discuss a potential registry. Those discussions were guided by published literature and publically available information on other registries. The task force presented their findings to the Council of the American Society for Surgery of the Hand in December 2019. At that time, a request was made specifically to determine what conditions or procedures would best deserve attention for study by a registry. This was the catalyst for convening this Delphi panel.
      The Delphi panelists in this exercise were composed of 13 hand surgical leaders from the ASSH. These included 4 members of the presidential line of the society (immediate past president, president, vice president, and next vice president), 7 council members from the society, one prior council member, and the editor-in-chief of the society’s academic journal. The process was designed and executed in conjunction with a survey methodology expert outside the field of hand surgery.
      The Delphi process consisted of 2 blinded, on-line Delphi panel rounds. In the first round, panelists were instructed that the goal of this process was to reach a consensus about which 2 registry topics had the greatest potential value for inclusion in a surgical registry. The survey presented 8 potential registry foci established by discussions among the registry task force and council. Topics included distal radius fractures, thumb carpometacarpal (CMC) arthritis, hand implant arthroplasty, wrist implant arthroplasty, flexor tendon repairs, replantation, cubital tunnel syndrome, and scapholunate (SL) ligament injury. At end of the survey, panelists were allowed to write in any topic that was not presented if they thought an additional topic should be considered. For each of the 8 potential topics, panelists ranked how important they deemed each topic for inclusion in a hand surgical registry using a scale in which 1 = not at all important and 9 = extremely important. After each rating, panelists explained their rationale. In round 1, panelists were recommended to consider several factors that may influence the value of a registry on any topic. Factors were those that the registry task force thought were relevant for registry topics:
      • 1.
        What is the frequency of surgery (for a given condition)?
      • 2.
        Is there variation in care that lends itself to study?
      • 3.
        Is there a void in our understanding of outcomes or limitation in outcomes?
      • 4.
        Does the topic present the opportunity for clinically relevant research that can be answered both in the short and long term?
      • 5.
        Will relevant data exist for automated extraction from health records?
      A priori, we had decided that the Likert scale would be interpreted with scores in which 1 to 3 indicated a topic was not important, 4 to 6 indicated intermediate importance, and 7 to 9 indicated high importance.
      • Dy C.J.
      • Antes A.L.
      • Osei D.A.
      • Goldfarb C.A.
      • DuBois J.M.
      The critical portions of carpal tunnel release, ulnar nerve transposition, and open reduction and internal fixation of the distal part of the radius.
      To be considered a consensus topic for a registry, a topic’s average score need to be 7 or greater and have 75% of panelists or greater score the condition in the 7 to 9 range. In round 2, panelists received summary statistics from round 1. We provided the anonymized qualitative statements from all panelists on the remaining topics being re-scored. Panelists were instructed to rescore the topics after considering comments from round 1.
      Thumb CMC arthritis was the only condition that reached our consensus thresholds in round 1 (mean rating, 7.2 ± 1.6; 85% of panelists rated in the 7–9 range). The rationale behind high ratings indicated that panelists saw the high frequency of this condition requiring surgery, and the presence of variation in care (within the United States and among countries) as advantageous for study.
      In round 1, replantation, hand implant arthroplasty, and wrist implant arthroplasty garnered the least support (Table 1). With only 8% to 23% of panelists providing a rating in the 7 to 9 range for these topics, they were removed from consideration at this point. No additional topics for consideration were written-in by panelists in round 1.
      Table 1Results From Round 1 of Delphi Survey (n = 13)
      ValueThumb CMC ArthritisDistal Radius FractureSL Ligament InjuryCubital Tunnel SyndromeFlexor Tendon RepairReplantationHand Implant ArthroplastyWrist Implant Arthroplasty
      Mean7.156.626.155.695.314.854.623.85
      SD1.631.982.151.892.872.151.761.77
      Median7.007.007.006.005.005.004.004.00
      Mode7.008.008.007.002.005.004.004.00
      7–9 ratings (% [n])85% (11)62% (8)54% (7)46% (6)46% (6)23% (3)23% (3)8% (1)
      In round 2, SL ligament injury became the second condition to reach consensus (mean rating, 7.1 ± 1.7; 83% of panelists rated in the 7–9 range). Qualitative comments indicated that interest in SL ligament injuries may warrant further study based on the number of unanswered questions regarding its treatment and the lack of a reliable surgical solution to this injury. No other topic rose above the consensus threshold (Table 2).
      Table 2Results From Round 2 of Delphi Survey
      n = 12 panelists.
      ValueSL Ligament InjuryDistal Radius FractureCubital Tunnel SyndromeFlexor Tendon Repair
      Mean7.086.505.255.33
      SD1.681.572.142.02
      Median7.006.505.505.00
      Mode7.006.002.005.00
      7–9 ratings (% [n])83% (10)50% (6)33% (4)25% (3)
      n = 12 panelists.
      Using a Delphi process, a panelist of ASSH leaders reached consensus that CMC arthritis and SL ligament injuries would be appropriate topics for a hand surgical registry. Thumb CMC arthritis is one of the most common degenerative joint conditions treated by hand surgeons. It affects up to 25% of women over age 50 years and 1 in 5 will require medical intervention to alleviate symptoms.
      • Zhang Y.
      • Niu J.
      • Kelly-Hayes M.
      • Chaisson C.E.
      • Aliabadi P.
      • Felson D.T.
      Prevalence of symptomatic hand osteoarthritis and its impact on functional status among the elderly: the Framingham Study.
      Although the surgical outcome of traditional ligament reconstruction and tendon interposition (LRTI) are reliable, several aspects of treating this joint are debated. Existing literature indicates that simple trapeziectomy and hematoma distraction produces functional results comparable to LRTI with shorter surgical times, fewer complications, and a lower cost.
      • Wajon A.
      • Ada L.
      • Edmunds I.
      Surgery for thumb (trapeziometacarpal joint) osteoarthritis.
      However, most hand surgeons in the United States continue to favor trapeziectomy with additional tendon suspension.
      • Yuan F.
      • Aliu O.
      • Chung K.C.
      • Mahmoudi E.
      Evidence-based practice in the surgical treatment of thumb carpometacarpal joint arthritis.
      Among Medicare beneficiaries, undergoing LRTI as opposed to trapeziectomy alone was associated with an additional cost of $1,308 with an extra $200 out-of-pocket.
      • Mahmoudi E.
      • Yuan F.
      • Lark M.E.
      • Aliu O.
      • Chung K.C.
      Medicare spending and evidence-based approach in surgical treatment of thumb carpometacarpal joint arthritis: 2001 to 2010.
      Conversion to simple trapeziectomy was estimated to create a potential annual savings of $74 million for Medicare. Additional treatment options include implant arthroplasty or denervation, both of which introduce more variation in care that may benefit from investigation.
      • Baek Hansen T.
      Joint replacement for trapeziometacarpal osteoarthritis: implants and outcomes.
      ,
      • Tuffaha S.H.
      • Quan A.
      • Hashemi S.
      • et al.
      Selective thumb carpometacarpal joint denervation for painful arthritis: clinical outcomes and cadaveric study.
      By contrast, SL ligament injuries are potentially debilitating injuries that affect a relatively small number of patients but can permanently change wrist function. To date, there is no consensus treatment for these injuries. A multitude of surgeries have been described, and yet none uniformly produce excellent results.
      • Micicoi G.
      • Micicoi L.
      • Dreant N.
      Dorsal intercarpal ligament capsulodesis: a retrospective study of 120 patients according to types of chronic scapholunate instability.
      • Bertelli J.A.
      • Vargas P.G.
      Reconstruction of the scapholunate ligament.
      • Garcia-Elias M.
      • Lluch A.L.
      • Stanley J.K.
      Three-ligament tenodesis for the treatment of scapholunate dissociation: indications and surgical technique.
      • Amadio P.C.
      • Berquist T.H.
      • Smith D.K.
      • Ilstrup D.M.
      • Cooney III, W.P.
      • Linscheid R.L.
      Scaphoid malunion.
      • Moran S.L.
      • Cooney W.P.
      • Berger R.A.
      • Strickland J.
      Capsulodesis for the treatment of chronic scapholunate instability.
      • Lavernia C.J.
      • Cohen M.S.
      • Taleisnik J.
      Treatment of scapholunate dissociation by ligamentous repair and capsulodesis.
      • Wyrick J.D.
      • Youse B.D.
      • Kiefhaber T.R.
      Scapholunate ligament repair and capsulodesis for the treatment of static scapholunate dissociation.
      • Luchetti R.
      • Zorli I.P.
      • Atzei A.
      • Fairplay T.
      Dorsal intercarpal ligament capsulodesis for predynamic and dynamic scapholunate instability.
      • Brunelli G.A.
      • Brunelli G.R.
      A new technique to correct carpal instability with scaphoid rotary subluxation: a preliminary report.
      • Ross M.
      • Loveridge J.
      • Cutbush K.
      • Couzens G.
      Scapholunate ligament reconstruction.
      • Links A.C.
      • Chin S.H.
      • Waitayawinyu T.
      • Trumble T.E.
      Scapholunate interosseous ligament reconstruction: results with a modified Brunelli technique versus four-bone weave.
      • Weiss A.P.
      Scapholunate ligament reconstruction using a bone-retinaculum-bone autograft.
      • Lee S.K.
      • Zlotolow D.A.
      • Sapienza A.
      • Karia R.
      • Yao J.
      Biomechanical comparison of 3 methods of scapholunate ligament reconstruction.
      Scapholunate ligament injuries are infrequent enough that it is difficult for any single surgeon or center to treat enough of these to conduct practice directing randomized trials. For this reason, a national registry of SL ligament injuries and treatment is thought to be necessary to compile individual experiences and to draw meaningful conclusions.
      The Swedish Society for Surgery of the Hand quality registry for hand surgery offers some guidance when considering registry establishment.
      • Arner M.
      Developing a national quality registry for hand surgery: challenges and opportunities.
      This hand surgical registry was established in 2010 and has 7 participating hand centers. Their experience has taught that creating simple logistics for data collection and continuous surveillance of data are necessary factors for success. When considering a new surgical registry, the importance of getting consensus for the need and goals of that registry are the first requirement. Our Delphi process was designed for this purpose. Further development and description for any registry on the consensus topics will consider the variables to be included and the manner in which data can be collected and maintained. The Scandinavian experience suggests that it is best to start with limited data as opposed to collecting too many data points and risking incomplete data. The society also recommended frequent feedback on results and data collection to participating institutions, which we agree will be critical to the success of a national hand surgery registry.
      Mandavia et al
      • Mandavia R.
      • Knight A.
      • Phillips J.
      • Mossialos E.
      • Littlejohns P.
      • Schilder A.
      What are the essential features of a successful surgical registry? A systematic review.
      performed a systematic review to determine the essential features of a successful surgical registry. They noted that registry efforts need to start with a steering committee and consider both clinical questions and information technology application. A registry should have a clear set of objectives and plans for sustainability. One of the key compromises is to balance comprehensive data collection with feasibility. Ideally, just the right amount of data are collected to answer the primary objectives. If patient-reported outcomes are included, minimizing the number of questions and remote administration via electronic means to patients is ideal.
      The consensus process reported in this article does not ensure the establishment or success of a national hand registry. However, it has confirmed a consensus of ideal conditions for study and is a first step toward considering a focused registry. If a hand surgery registry is successful, it will offer the opportunity to reduce the cost of care, improve outcomes, and curb variation in care. A registry for hand surgery can be an important tool for developing and tracking quality measures that are meaningful to hand surgeons and specific to the ambulatory and discretionary nature of hand surgery that is consistent with the national directive for value-based care. A registry established by the ASSH offers an engagement opportunity for hand surgeons in the national health policy dialogue that requires active surgeon engagement.

      References

        • Drolet B.C.
        • Johnson K.B.
        Categorizing the world of registries.
        J Biomed Inform. 2008; 41: 1009-1020
        • Drolet B.C.
        • Lorenzi N.M.
        Registries and evidence-based medicine in craniofacial and plastic surgery.
        J Craniofac Surg. 2012; 23: 301-303
        • Delaunay C.
        Registries in orthopaedics.
        Orthop Traumatol Surg Res. 2015; 101: S69-S75
        • Wurzer P.
        • Hundeshagen G.
        • Cambiaso-Daniel J.
        • et al.
        Lessons learned from breast implant registries: a systematic review.
        Ann Plast Surg. 2019; 83: 722-725
        • American Academy of Orthopaedic Surgeons
        About the AAOS Registry Program.
        (Available at:)
        • Maggard-Gibbons M.
        The use of report cards and outcome measurements to improve the safety of surgical care: the American College of Surgeons National Surgical Quality Improvement Program.
        BMJ Qual Saf. 2014; 23: 589-599
        • Arner M.
        Developing a national quality registry for hand surgery: challenges and opportunities.
        EFORT Open Rev. 2016; 1: 100-106
        • Bae D.S.
        • Canizares M.F.
        • Miller P.E.
        • Waters P.M.
        • Goldfarb C.A.
        Functional impact of congenital hand differences: early results from the Congenital Upper Limb Differences (CoULD) registry.
        J Hand Surg Am. 2018; 43: 321-330
        • Dy C.J.
        • Antes A.L.
        • Osei D.A.
        • Goldfarb C.A.
        • DuBois J.M.
        The critical portions of carpal tunnel release, ulnar nerve transposition, and open reduction and internal fixation of the distal part of the radius.
        J Bone Joint Surg Am. 2018; 100: e148
        • Zhang Y.
        • Niu J.
        • Kelly-Hayes M.
        • Chaisson C.E.
        • Aliabadi P.
        • Felson D.T.
        Prevalence of symptomatic hand osteoarthritis and its impact on functional status among the elderly: the Framingham Study.
        Am J Epidemiol. 2002; 156: 1021-1027
        • Wajon A.
        • Ada L.
        • Edmunds I.
        Surgery for thumb (trapeziometacarpal joint) osteoarthritis.
        Cochrane Database Syst Rev. 2005; 4: CD004631
        • Yuan F.
        • Aliu O.
        • Chung K.C.
        • Mahmoudi E.
        Evidence-based practice in the surgical treatment of thumb carpometacarpal joint arthritis.
        J Hand Surg Am. 2017; 42 (104.e101–112.e101)
        • Mahmoudi E.
        • Yuan F.
        • Lark M.E.
        • Aliu O.
        • Chung K.C.
        Medicare spending and evidence-based approach in surgical treatment of thumb carpometacarpal joint arthritis: 2001 to 2010.
        Plast Reconstr Surg. 2016; 137: 980e-989e
        • Baek Hansen T.
        Joint replacement for trapeziometacarpal osteoarthritis: implants and outcomes.
        J Hand Surg Eur Vol. 2021; 46: 115-119
        • Tuffaha S.H.
        • Quan A.
        • Hashemi S.
        • et al.
        Selective thumb carpometacarpal joint denervation for painful arthritis: clinical outcomes and cadaveric study.
        J Hand Surg Am. 2019; 44: 64.e1-64.e8
        • Micicoi G.
        • Micicoi L.
        • Dreant N.
        Dorsal intercarpal ligament capsulodesis: a retrospective study of 120 patients according to types of chronic scapholunate instability.
        J Hand Surg Eur Vol. 2020; 45: 666-672
        • Bertelli J.A.
        • Vargas P.G.
        Reconstruction of the scapholunate ligament.
        J Hand Surg Am. 1999; 24: 200-201
        • Garcia-Elias M.
        • Lluch A.L.
        • Stanley J.K.
        Three-ligament tenodesis for the treatment of scapholunate dissociation: indications and surgical technique.
        J Hand Surg Am. 2006; 31: 125-134
        • Amadio P.C.
        • Berquist T.H.
        • Smith D.K.
        • Ilstrup D.M.
        • Cooney III, W.P.
        • Linscheid R.L.
        Scaphoid malunion.
        J Hand Surg Am. 1989; 14: 679-687
        • Moran S.L.
        • Cooney W.P.
        • Berger R.A.
        • Strickland J.
        Capsulodesis for the treatment of chronic scapholunate instability.
        J Hand Surg Am. 2005; 30: 16-23
        • Lavernia C.J.
        • Cohen M.S.
        • Taleisnik J.
        Treatment of scapholunate dissociation by ligamentous repair and capsulodesis.
        J Hand Surg Am. 1992; 17: 354-359
        • Wyrick J.D.
        • Youse B.D.
        • Kiefhaber T.R.
        Scapholunate ligament repair and capsulodesis for the treatment of static scapholunate dissociation.
        J Hand Surg Br. 1998; 23: 776-780
        • Luchetti R.
        • Zorli I.P.
        • Atzei A.
        • Fairplay T.
        Dorsal intercarpal ligament capsulodesis for predynamic and dynamic scapholunate instability.
        J Hand Surg Eur Vol. 2010; 35: 32-37
        • Brunelli G.A.
        • Brunelli G.R.
        A new technique to correct carpal instability with scaphoid rotary subluxation: a preliminary report.
        J Hand Surg Am. 1995; 20: S82-S85
        • Ross M.
        • Loveridge J.
        • Cutbush K.
        • Couzens G.
        Scapholunate ligament reconstruction.
        J Wrist Surg. 2013; 2: 110-115
        • Links A.C.
        • Chin S.H.
        • Waitayawinyu T.
        • Trumble T.E.
        Scapholunate interosseous ligament reconstruction: results with a modified Brunelli technique versus four-bone weave.
        J Hand Surg Am. 2008; 33: 850-856
        • Weiss A.P.
        Scapholunate ligament reconstruction using a bone-retinaculum-bone autograft.
        J Hand Surg Am. 1998; 23: 205-215
        • Lee S.K.
        • Zlotolow D.A.
        • Sapienza A.
        • Karia R.
        • Yao J.
        Biomechanical comparison of 3 methods of scapholunate ligament reconstruction.
        J Hand Surg Am. 2014; 39: 643-650
        • Mandavia R.
        • Knight A.
        • Phillips J.
        • Mossialos E.
        • Littlejohns P.
        • Schilder A.
        What are the essential features of a successful surgical registry? A systematic review.
        BMJ Open. 2017; 7e017373