Facilitating surgical decisions for patients who are uncertain: a pilot surgical option process within an interdisciplinary functional restoration program

Facilitating surgical decisions for patients who are uncertain: a pilot surgical option process within an interdisciplinary functional restoration program

The Spine Journal - (2014) - Clinical Study Facilitating surgical decisions for patients who are uncertain: a pilot surgical option process withi...

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The Spine Journal

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(2014)

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Clinical Study

Facilitating surgical decisions for patients who are uncertain: a pilot surgical option process within an interdisciplinary functional restoration program Emily Brede, PhD, RNa, Tom G. Mayer, MDb,*, Whitney E. Worzer, MS, CRCa, Maile Shea, RN, MS, FNPa, Cristina Garcia, RMAa, Robert J. Gatchel, PhD, ABPPc a PRIDE Research Foundation, 5701 Maple Ave, Suite 100, Dallas TX, 75235, USA Department of Orthopaedic Surgery, The University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Blvd, Dallas, TX 75390-9003, USA c Department of Psychology, College of Science, The University of Texas at Arlington, Box 191528, 313 Life Sciences Building, Arlington, TX 76019-0528, USA

b

Received 2 February 2011; revised 12 June 2013; accepted 25 June 2013

Abstract

BACKGROUND CONTEXT: For chronic pain patients, recovery may be slowed by indecisiveness over optional surgery. These patients may be delayed from participating in interdisciplinary functional restoration (FR), pending resolution of the surgical decision. Uncertainty about surgery or rehabilitation leads to delayed recovery. A surgical option process (SOP) was developed to permit patients with chronic disabling occupational musculoskeletal disorders to enter FR, make a final determination halfway through treatment, and return to complete rehabilitation after surgery, if surgery was elected. PURPOSE: This study assessed the frequency with which an FR program can resolve an uncertain surgical option. It also assessed program completion rate and 1-year post-program outcomes for subgroups that decline surgery, request and receive surgery, or request surgery but are denied by surgeon or insurance carrier. STUDY DESIGN: Retrospective study of a consecutive cohort. PATIENT SAMPLE: A cohort of 44 consecutively treated chronic disabling occupational musculoskeletal disorder patients were admitted to an FR program and identified as candidates for a surgical procedure but were either ambivalent about undergoing surgery, had a difference of opinion by two or more surgeons, or were denied a surgical request by an insurance carrier. Patients attended half (10 full day visits) of an FR program before making their own final determination to pursue a request or decline surgery. OUTCOME MEASURES: Patients were assessed on surgical requests and whether surgery was ultimately performed, program completion status after the surgical determination, demographic variables, and 1-year outcomes on work status, additional surgery, and other health utilization measures. METHODS: Patients became part of the SOP on program entry and were included in the study if they participated in a surgical-decision interview halfway through the program. Those who elected to decline surgery (DS) completed the program without delay, but those requesting surgery were placed on hold from the program while consultation and preauthorization steps took place. Those requesting surgery, but denied (RSD), and those undergoing surgery (US) were given the opportunity to complete FR following postoperative physical therapy or resolution of the surgical re-evaluation process.

FDA device/drug status: Not applicable. Author disclosures: EB: Nothing to disclose. TGM: Nothing to disclose. WEW: Nothing to disclose. MS: Nothing to disclose. CG: Nothing to disclose. RJG: Grant: National Institutes of Health (I, Paid directly to institution/employer); Grant: Department of Defense (H, Paid directly to institution/employer); Royalties: Guilford Press (B), APA Press (B), Springer (B); Consulting: PRIDE (B); Scientific Advisory Board/Other Office: Pallidian Health Care (B); Endowments: Nancy P. and John G. Penson Endowed Professorship in Clinical Health Psychology (F). The disclosure key can be found on the Table of Contents and at www. TheSpineJournalOnline.com. 1529-9430/$ - see front matter Ó 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.spinee.2013.06.108

The contents of this study were accepted as podium presentation for the 2010 NASS meeting in Orlando, FL. The writing of this article was supported in part by Grant 1K05 MH 71892 from the National Institutes of Health. This Senior Scientist Award to Dr Gatchel focuses on evidence-based assessment and treatment approaches to musculoskeletal pain, as well as the monitoring of valid outcomes. * Corresponding author. PRIDE Research Foundation., 5701 Maple Ave. #100, Dallas, TX 75235, USA. Tel.: (214) 351-6600; fax: (214) 351-3026. E-mail address: [email protected] (T.G. Mayer)

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RESULTS: There were 32 DS patients (73%), indicating that a large majority of patients declined the surgery that was still being considered when offered participation in the SOP. Of the 12 patients wanting a surgery, there were four US patients who received surgery previously denied (9% of cohort), and eight RSD patients (18% of cohort). Patients from the DS group completed the FR program at an 88% rate, as did 75% of US patients. However, despite an opportunity to re-enter and complete rehab, only 50% of RSD patients completed the FR option. Overall, patients who persistently sought surgery, contrary to the recommendations of a surgeon, had poorer outcomes. These 1-year post-FR outcomes included lower return-to-work and work retention rates, with higher rates of treatment seeking from new providers (resulting in higher rates of post-discharge surgery) and higher rates of recurrent injury claims after work return. CONCLUSIONS: A SOP tied to participation in an interdisciplinary FR program resolves uncertainty regarding surgical options in a high proportion of cases, resulting in a large majority declining surgery and completing the FR program. Timely surgery is also promoted decisively when needed. Findings suggest that patients who persistently seek surgery, contrary to the recommendations of a surgeon, frequently fail to complete FR and have poorer outcomes overall. Ó 2014 Elsevier Inc. All rights reserved. Keywords:

Surgical option process; Chronic disabling occupational musculoskeletal disorders; Interdisciplinary; Functional restoration; Spinal fusion; Patient decision; Socioeconomic outcomes; Return to work

Introduction Decisions regarding surgical options, and associated costs and outcomes, have rapidly become a prominent focus in the health care arena. Historically, non-operative care is recommended to be exhausted before elective orthopedic surgical intervention, and current nationally used clinical practice guidelines such as the Official Disability Guidelines (ODG) and the American College of Occupational and Environmental Medicine guidelines reinforce this accepted practice in the occupational health care setting [1,2]. If standard nonoperative interventions are not sufficient to provide complete recovery, careful patient selection on the part of surgeons and other providers, as well as consent from the patient and insurance carrier, is required before surgery. In many US Workers’ Compensation (WC) jurisdictions, a pre-authorization process for insurance carrier approval provides an additional hurdle before spinal, or any musculoskeletal, surgery [1,2]. Particularly when dealing with chronic disabling occupational musculoskeletal disorders (CDOMDs), disagreements over medical evidence, or uncertainty about what constitutes a carefully selected patient, may lead to costly and timeconsuming dispute resolution procedures [3]. In some cases, even a collaborative determination by the treatment team and the patient that non-operative care has been unsuccessful may be trumped by a utilization review doctor who disagrees with the interpretation of a treatment guideline. To date, guidelines about how to make a surgical decision remain understandably ambiguous. However, because interdisciplinary programs such as functional restoration (FR) and chronic pain management are acknowledged in the guidelines to be the most intensive type of non-operative rehabilitation [1,2,4], if a patient does not demonstrate the expected progress in such a program, a re-evaluation of the disputed surgical procedure may be warranted. The myriad of factors that go into a surgical decision can confuse all parties involved, produce resentment among

patients, and ultimately delay treatment of any kind. In this way, surgical ambiguity may often prevent the appropriate medical progression of treatments, with a greater likelihood of undesirable outcomes, such as disability, deconditioning, drug dependence, and progressive psychosocial deterioration. Furthermore, CDOMD patients may be particularly difficult to treat, even with appropriate surgical care. For example, in a study of Ohio WC patients who received lumbar fusions, only 26% had returned to work at 2 years after surgery, whereas 27% underwent reoperation, and 85% remained on opioid pain medications [5]. Recent studies document a 220% increase in lumbar spinal fusion surgery rates, without demonstrated improvements in patient outcomes or disability rates [6]. In some cases, a physiological problem is evident and clear indications favoring lumbar fusion are present. These non-controversial indications for spinal surgeries include vertebral fractures and dislocations, spinal tumors, scoliosis, segmental instability (often after prior discectomy), and spondylolisthesis [7–9]. Of all musculoskeletal surgeries, lumbar fusion surgery is now by far the most common to be denied by insurance carriers in WC state jurisdictions mandating the use of treatment guidelines. In these cases, it is not unusual that a lumbar fusion is suggested by a surgeon for chronic axial pain, but patients are often uncertain because of what they have heard or read. In other cases, when an insurance carrier disputes the surgical procedure based on a treatment guideline or when multiple second opinions produce conflicting recommendations, the net result is a stalemate that impedes the treatment process, leading to delayed recovery. Not only does this stalemate adversely affect the injured worker but it creates problems for the WC carrier because financial benefits are linked to medical benefits. When treatment is delayed, financial benefits persist unresolved, and the point of Maximum Medical Improvement cannot be achieved

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because medical care is suspended until the surgical dispute is ended. The problem of uncertainty about undergoing elective orthopedic surgery leading to delayed recovery is evident; however, a solution to the problem has been difficult to identify. Therefore, the development of a surgical option process (SOP) associated with interdisciplinary FR was undertaken to provide a resolution to this impasse. There has been evidence supporting the use of certain FR programs to resolve chronic disability with promising long-term work and socioeconomic outcomes [1,10–19]. A comprehensive interdisciplinary rehabilitation program that uses a coordinated and goal-directed approach and has ‘‘proven successful outcomes’’ is recommended by some evidence-based treatment guidelines, such as ODG [1]. Such interdisciplinary programs include components such as physical treatments, medical care and supervision, psychological/behavioral care, psychosocial care, vocational rehabilitation or training, and education delivered in an integrated fashion [1]. The specific FR program used in the present study has a well-documented record of promoting desirable functional and socioeconomic outcomes in CDOMD patients (B. R. Theodore, T. G. Mayer, R. J. Gatchel, unpublished data, 2012) [10–13,19–23]. Positive results have been found in several international trials using similarly designed programs [24–31]. The goal of the SOP was to permit patients with CDOMD to enter a structured interdisciplinary treatment program (specifically an FR program) and make a final surgical determination halfway through treatment. Patients who believed that progress had been substantial and who expected further recovery generally chose to decline surgery and complete rehabilitation. If the patient was unconvinced about progress, the patient could re-enter the pre-authorization process and was assisted in obtaining the appropriate surgical consultation and, if necessary, additional diagnostic tests or a dispute resolution process. If surgery was received, the patient was invited to return to complete the rehabilitation program after post-operative physical therapy without ‘‘starting from the beginning.’’ Based on our literature search, no prior evidence has been provided regarding a formal SOP for addressing ambiguity about elective orthopedic surgery once it has arisen. This pilot study assesses the frequency with which a structured interdisciplinary rehabilitation treatment program can aid in the resolution of an uncertain surgical option and facilitate timely treatment either with surgery or with nonoperative care. The study also assesses program completion rate and 1-year post-program outcomes for subgroups that decline surgery, request and receive surgery, or request surgery but are denied by surgeon or carrier.

Methods Participants The current cohort study identified 44 consecutive patients, with an unresolved surgical option from among the

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1,162 patients admitted for interdisciplinary FR between January 2004 and December 2007, who consented to participate in the structured FR program. All patients were referred by primary and secondary care providers for rehabilitation of CDOMDs under WC insurance and consented to participate in the structured FR program. Inclusion criteria for participation in the FR program were total or partial disability of at least 4 months, failure of prior non-operative and surgical care to resolve disability satisfactorily, persistent severe pain with functional limitations, and able to communicate in English or Spanish. The surgical option process was part of the standard FR program, and all patients with an elective surgical opportunity were offered participation in this program as a component of treatment. The study was granted an exemption from review by the institutional review board, as data were part of the standard medical records. As all study data were collected from this standardized program’s medical records, by definition this is a retrospective study of existing patients’ records. To be part of SOP, patients needed to remain in the program until SOP decision meeting with the program supervising physician. Thereafter, patients were part of the process, whether they completed the full course of FR or not. An unresolved surgical option was defined in four ways: surgery was requested by the surgeon but denied by the insurance carrier, the patient was undecided about the surgical option presented by the surgeon, surgery was presented as a treatment option but no formal authorization request was made, and the treating surgeon’s authorization request was withdrawn due to disagreement with the surgeon consulted for a second opinion. This cohort was divided into the following subgroups based on SOP decision at FR program midpoint: (1) Decline surgery (DS): The DS group consisted of 32 patients who declined surgery, with the intent to complete the FR program. (2) Undergoing surgery (US): The US group consisted of four patients, who elected the surgical option at program mid-point, were approved despite the prior uncertainty, and underwent surgery. Surgeries were performed in the following sequence: the patient went on a ‘‘medical hold’’ status after the SOP decision, had a surgical consultation, received preauthorization approval from the WC insurance carrier, had surgery and immediate postoperative rehab, and was invited to resume the FR program. (3) Requested surgery, but were denied (RSD): The RSD group consisted of eight patients who requested surgery at SOP decision point but were denied surgery by the evaluating surgeon. They were offered the opportunity to complete FR after the consultation or dispute resolution was complete. Figure shows the reasons for entry into the SOP program, the number of patients in the SOP subgroups, and

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Figure. Patient flow through the study and losses to follow-up.

the patient data lost to follow-up at 1 year after FR discharge. Procedure The interdisciplinary FR program used in this study included a quantitatively directed exercise progression, administered by a treatment team including physical and occupational therapists [4,32–34]. The program was medically supervised to allow for simultaneous medication management (including psychotropic medications and opioid taper), as well as limited interventional procedures, if needed. In addition, patients participated in a multi-modal disability management program, which consisted of cognitive-behavioral counseling, stress management, biofeedback and relaxation training, vocational rehabilitation/reintegration, medical case management, and education [4,19,35]. The specific FR program used for the present study has a well-documented record of successful socioeconomic outcomes that are particularly relevant to the WC setting (B. R. Theodore, T. G. Mayer, R. J. Gatchel, unpublished data, 2012) [10–13,19–23]. Measures At the admission to the FR program, demographic data were collected along with comprehensive physical and

psychosocial assessments. The results of SOP decisions during the program, program completion rates after surgical determination, and type of surgery performed or requested after the SOP decision were evaluated at the SOP decision point (FR program mid-point) and at the conclusion of the FR program. The definition of program ‘‘completion’’ represented either: usual program discharge at the end of the FR program or date patient was discharged from FR after the SOP surgical determination meeting without meeting program criteria. Socioeconomically relevant outcomes were collected 1-year after completion of the program, using a structured interview format. For this study, six objective outcomes were evaluated: return-to-work (RTW) at any time post-FR, work retention 1 year after program completion, treatment seeking by visits to a new health care provider, new surgery to the body part involved in SOP, recurrent injury claim with lost time after RTW, and claim settlement for the WC case. The relevance and validity of these socioeconomic outcomes have been documented in evidencebased practice guidelines (ODG and American College of Occupational and Environmental Medicine), and several previous studies have demonstrated the utility of these outcomes in documenting response to FR treatment [1,2,18,19,36,37].

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Table 1 Demographic variables by SOP group* Variables Gender (male), n (%) Age (y), mean (SD) Completed functional restoration, n (%) Length of disability (mo), mean (SD) Type of injury, n (%) Lumbar or thoracic spine Upper extremity Lower extremity Spinalþextremity injuries Type of surgery declined, n (%) Cervical spine fusion Lumbar fusion Lumbar spine (other) Knee Upper extremity Type of surgery received, n (%) Lumbar fusion Shoulder rotator cuff repair Knee meniscectomy Type of surgery requested but denied, n (%) Lumbar fusion Cervical spine fusion Shoulder decompression Knee replacement

Declined surgery (n532)

Underwent surgery (n54)

Requested surgery but denied (n58)

21 45.0 28 30.8

(66) (9.8) (88) (39.3)

4 40.5 3 17.5

(100) (6.0) (75) (1.3)

5 48.9 4 13.1

(63) (6.0) (50) (11.3)

21 3 2 6

(66) (9) (6) (19)

2 1 0 1 N/A

(50) (25) (0) (25)

4 0 0 4 N/A

(50) (0) (0) (50)

4 13 7 4 4 N/A 2

(13) (41) (22) (13) (13)

p .353 .310 .061 .381 .489

N/A (50)

N/A

1 (25) 1 (25) N/A 4 2 1 1

(50) (25) (13) (13)

SOP, surgical option process; SD, standard deviation; N/A, Not Applicable. * SOP group was determined at rehab program mid-point.

Statistical analyses Data were analyzed using a commercially available statistical software package (IBM SPSS Statistics for Windows, Version 20.0.; IBM Corp., Armonk, NY, USA). For the categorical variables, tests of association were conducted based on the Pearson chi-square (c2) test statistic for all analyses of the differences between the DS, US, and RSD groups. Continuous variables were compared using analyses of variance. Cohen’s w was used as the effect size measure for the evaluation of 1-year socioeconomic outcomes [38]. Post hoc pairwise comparisons were computed between the DS and RSD groups using the c2 test with the odds ratio as the measure of effect size.

Results The majority of patients in this study declined surgery at the SOP decision meeting (Figure). This DS group consisted of 32 (73%) patients. Of the 12 patients requesting a new surgical consultation, four patients (9% of the entire cohort) received surgery (US group), whereas eight patients (18% of the cohort) were denied surgery after a new consultation process (RSD group). The RSD patients were all denied based on surgical consultations, either by their original surgeon or a new surgeon not previously involved in the request; no surgical requests were denied after the SOP process by

a WC insurance carrier. Patients usually completed the FR program within 4 to 6 weeks, if surgery was not involved (mean517.3 weeks; range, 5–35 weeks), but FR completion for the surgery patients took as long as 8 months (mean544.1 weeks; range, 39–51 weeks) due to surgical consultations, further disputes, and authorization processes. Table 1 displays the basic demographic variables characterizing the three groups. No statistically significant differences were found among the groups on any demographics. The DS patients completed the FR program at an 88% rate, as did 75% of US patients. However, despite an opportunity to re-enter and complete rehab, only 50% of RSD patients completed the rehab option. Table 1 also shows the surgeries that were declined, performed, and denied. The majority of the US patients chose to return and complete the FR program. Table 2 presents the socioeconomic outcomes collected at 1-year post-discharge. Patients from the DS and US groups returned to, and retained, work at a higher rate than RSD patients, although these differences were not statistically significant. More than half of the RSD patients continued to pursue surgery, this time with a new surgical consultant or treating doctor. One of the eight patients received a lumbar fusion in the year post-FR, despite earlier denials, and did not RTW after surgery. In addition, one DS patient changed his mind and underwent a total knee replacement in the year following completion of FR after initially declining the surgery during SOP. Of the members of

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Table 2 Outcome variables by SOP groups Outcome measure

Declined surgery (n532)

Underwent surgery (n54)

Requested surgery but denied (n58)

p

Effect size

Return to work, n (%) Work retention, n (%) Seeking treatment from a new provider, n (%) Recurrent injury claim to original site with lost time,x n (%) New surgery post-treatment, n (%) Case settlement, n (%)

29 28 1 1 1 30

4 4 0 0 0 4

6 5 4 4 1 8

.347 .148 .001 .001 .471 .675

0.22* 0.30y 0.57z 0.62z 0.18* 0.13*

(91) (88) (3) (4) (3) (94)

(100) (100) (0) (0) (0) (100)

(75) (63) (50) (57) (12.5) (100)

* Small effect size. y Medium effect size. z Large effect size. x Six patients had missing data for new injury claims.

the RSD group who did RTW, 60% filed a new WC injury claim and had additional lost time. Overall, patients whose surgical requests were denied had poorer outcomes. These outcomes included lower RTW and work retention rates, increases in health care utilization by continuing to seek treatment from additional health care providers, and filing a greater number of new WC injury claims with lost time. Table 3 shows direct pairwise comparisons between the DS group and the RSD group. DS patients were seven times more likely to complete the FR program than those who still wanted to pursue surgery at the mid-point interview but were denied (RSD). Additionally, Table 3 reveals the significant between-groups difference in health care utilization and new WC injury claims. Patients who requested surgery, but were denied, were 31 times more likely to seek additional treatments from new providers. The RSD patients were also 35 times more likely to claim another injury than DS patients.

Discussion An unresolved elective surgical option may lead to delayed recovery in a number of ways. However, a simple declaration that non-operative care has been ‘‘exhausted’’ may be insufficient to move the process toward surgery, particularly in the WC setting using treatment guidelines. For this reason, a SOP linked to interdisciplinary FR is

an appealing option. The present study suggests that a number of important, socioeconomically relevant outcomes can be achieved when patients are given the opportunity to participate in the first half of the FR program before making the final surgical decision. In fact, 73% of patients made personal decisions to continue to avoid surgery and complete rehabilitation, despite being unable to reach a decision before participation in the SOP (DS group). This group had excellent work outcomes, and only one patient (3%) had surgery to the originally affected body part in the ensuing year. Of the small number of patients who elected to pursue surgery at the surgical decision point and subsequently underwent surgery (US group), all four completed the FR program, returned to work after discharge, retained work 1 year later, and settled their WC claims. None of these patients had recurrent injuries or additional surgery. On the other hand, the group requesting a surgery, but subsequently denied (RSD group) showed significantly poorer outcomes. Only half completed the rehabilitation program when given an option to do so, and only 75% returned to, and 63% retained, work 1 year later. Of these patients, 57% continued seeking treatment from other health professionals, persisting in efforts to obtain surgery that they believed was necessary. Of those who returned to work, 60% claimed a new WC injury with lost time to the original site, possibly related to ongoing psychosocial distress. Only one of these patients succeeded in obtaining

Table 3 Pairwise comparisons of outcome variables between DS and RSD groups 95% Confidence interval for odds ratio Outcome measure

DS (n532)

RSD (n58)

p

Odds ratio

Upper limit

Lower limit

Program completion, n (%) Return to work, n (%) Work retention, n (%) Seeking treatment from a new provider, n (%) Recurrent injury claim to original site with lost time,* n (%) New surgery post-discharge, n (%)

28 29 28 1

4 6 5 4

(50) (75) (63) (50)

.018 .232 .096 !.001

7.00 3.22 4.20 31.0

1.23 0.44 0.71 2.74

39.8 23.7 24.8 350.8

1 (4)

4 (57)

!.001

34.7

2.86

420.6

1 (3)

1 (12.5)

0.25

79.7

(88) (91) (88) (3)

DS, declined surgery; RSD, requested surgery but denied. * Six patients had missing data for new injury claims.

.277

4.43

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surgery to the original site, suggesting that the surgeon’s initial decision not to recommend surgery was upheld by subsequent providers in most cases. While we do not know what would have occurred if the other patients from the RSD group had subsequently obtained surgery, the one RSD patient who achieved surgery did not RTW and was using high-dose opioids at the 1-year interview, some 6 months post-lumbar fusion. In addition to the specific benefits to the various groups previously mired in ambivalence and treatment delays, theSOP may have had other beneficial effects. Presence in either the DS or US groups (82% of patients) ended the indecision regarding surgery or rehabilitation options and was associated with socioeconomic outcomes of great relevance to the WC system. Furthermore, those patients persistently seeking surgery contrary to surgeon recommendations appears to be a risk factor for poorer outcomes (failure to complete rehab, poor physical progress, less work return/ retention, high recurrent injury rates for those who RTW), and therefore this group can be targeted for more intensive interventions and follow-up after resolution of the surgical option. The interests of patients, employers, insurance carriers, and WC system administrators will benefit by the restoration of the orderly flow of medical care toward Maximum Medical Improvement and the seemingly appropriate determination of surgical indications through a SOP. It should be noted that this was a small pilot study based on a perceived clinical need and results cannot necessarily be generalized to other centers. In addition, the patients were unequally distributed among the groups. While these unequal group sizes are potentially detrimental to the statistical analysis, it should be noted that smaller numbers of patients electing to pursue surgery are highly desirable from a clinical standpoint. Finally, while delayed recovery has long been recognized as a common problem in the WC setting, the specific contribution of surgical uncertainty is a relatively new consideration. This prospective study was implemented at a time when a relatively small proportion of patients were identified as eligible to participate in the SOP. However, the frequency of SOP cases has gradually increased, and a larger study in this index facility is currently being analyzed. Adoption of a similar SOP in other facilities and WC jurisdictions may increase the generalizability of these findings.

Conclusions A SOP tied to participation in an interdisciplinary FR program may contribute to the resolution of uncertainty regarding elective orthopedic surgery among patients with CDOMDs, with the majority declining surgery and completing the rehabilitation program. Timely surgery may also be promoted decisively when indicated. Findings suggest that patients who specifically seek surgery contrary to the recommendations of a surgeon have poorer outcomes overall.

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