Measuring expectations is acknowledged as an important

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1 SPINE Volume 38, Number 9, pp , Lippincott Williams & Wilkins CERVICAL SPINE Development of an Expectations Survey for Patients Undergoing Cervical Spine Surgery Carol A. Mancuso, MD, * Frank P. Cammisa, MD, Andrew A. Sama, MD, Alexander P. Hughes, MD, and Federico P. Girardi, MD Study Design. Cross-sectional analysis of patient-reported preoperative data. Objective. To develop a valid and reliable patient-derived expectations survey for patients undergoing cervical spine surgery. Summary of Background Data. Measuring expectations is an important component in the assessment of patients undergoing cervical spine surgery. However, there currently are no uniform methods to measure expectations. Methods. This study was conducted in 3 phases. In phase 1, patients were queried with open-ended questions about what they expected as a result of surgery. Their responses were grouped into categories that became the items in the draft survey. During phase 2, another group of patients completed the draft survey twice to establish test-retest reliability. In phase 3, items were selected on the basis of concordance and clinical relevance and a scoring rubric was developed. Results. Phase 1: 25 patients with radiculopathy, myelopathy, or previous surgery with failed fusion (nonunion) (mean age, 55 yr, 44% women) volunteered 114 expectations from which 31 categories were discerned and became the items in the draft survey. Phase 2: another 25 patients completed the survey twice before surgery, a mean of 5 days apart. Phase 3: 21 items were retained for the final survey addressing pain, numbness, physical limitations, and psychological well-being. An overall score can be calculated ranging from 0 to 100 that incorporates number of items expected and degree of improvement expected. For patients in phase 2, scores for the first and second administrations were 58 and 57, Cronbach α coefficients were 0.90 and 0.93, and the intraclass correlation coefficient between scores was From the * Hospital for Special Surgery, Weill Cornell Medical College, New York, NY; and Hospital for Special Surgery, New York, NY. Acknowledgment date: March 29, First revision date: September 25, Second revision date: October 29, Acceptance date: October 30, The manuscript submitted does not contain information about medical device(s)/drug(s). No funds were received in support of this work. Relevant financial activities outside the submitted work: consultancy, stock/ stock options, royalties, payment for scientific advisory board membership. Address correspondence and reprint requests to Carol A. Mancuso, MD, Hospital for Special Surgery, 535 East 70th Street, New York, NY 10021; mancusoc@hss.edu Conclusion. We developed a valid and reliable patient-derived expectations survey for patients undergoing cervical spine surgery that addresses expectations for physical and psychological well-being and generates an easy-to-interpret overall score. The survey can be used clinically and for research and fills a gap in the comprehensive preoperative assessment of patients undergoing cervical spine surgery. Key words: expectations, cervical, survey, reliable, retest, weighted κ. Spine 2013 ; 38 : Level of Evidence: 1 Measuring expectations is acknowledged as an important component in the assessment of patients undergoing cervical spine surgery. 1 However, few studies have prospectively addressed expectations, and there currently are no uniform methods to measure expectations. The topic of expectations is particularly challenging for patients undergoing cervical spine surgery because, in addition to pain and neuromuscular impairment, psychological features markedly and reciprocally augment the clinical picture and affect patients perspectives. 2, 3 Expectations of surgery have been the subject of diverse studies in orthopedics, but most studies used physician-derived nonvalidated questions that addressed a few broad categories, such as pain relief and improvement in daily activities. 1, 3 Some studies, however, showed that aside from pain relief, expectations of orthopedic surgery are condition-specific and patientspecific based on lifestyle characteristics Thus, querying patients is essential to identify expectations that are most relevant to specific conditions and that are most important to patients, even if they are unrealistic. The purpose of this study was to ascertain patients expectations of cervical spine surgery and to develop a valid and reliable patient-derived expectations survey. Our goal was also to compare expectations to degree of disability and psychological well-being. MATERIALS AND METHODS We used standard qualitative and quantitative techniques to develop and test the survey for psychometric properties, including several types of validity. As outlined below, content validity was established by deriving items for the survey solely from input from patients and by verifying from surgeons that the items are frequently encountered in clinical practice. DOI: /BRS.0b013e31827bf April 2013

2 Construct validity was addressed by comparing expectations with functional status measured by a standardized scale. Discriminative validity was assessed by comparing expectations between 2 different diagnoses. We hypothesized that patients would have diverse expectations that encompass both physical and psychological well-being, and amount of improvement expected would vary from some to complete improvement. We also hypothesized that patients with more disability would have higher expectations because their limitations probably affect more areas of function. The institutional review board at Hospital for Special Surgery approved this study and all participants provided written informed consent. This cross-sectional study was carried out in 3 phases. Phase 1. Identifying Expectations and Assembling the Draft Survey Identifying Expectations Consecutive patients scheduled for cervical spine surgery by 1 of 4 participating spine surgeons were approached when they presented for preoperative testing several days before surgery. Patients were eligible if they were 18 years of age or older, spoke English fluently, and could provide informed consent. Patients undergoing repeat surgery were included to permit generalizability to the large proportion of patients who ultimately have surgery again for the same or a new condition. Patients were excluded if they were undergoing emergency surgery or refused to participate. Patients were interviewed in person and were asked these open-ended questions: What do you expect as a result of your spine surgery? After you have recuperated from your surgery, what do you expect will be different? Patients were encouraged to volunteer as many expectations as they wished and their responses were written down in field notes. Throughout the interview, patients were reminded that we were inquiring about what they thought actually would be the result of surgery, not what they wished or hoped for. For each item, patients were also asked how much improvement they expected with response options of complete improvement, back to normal, not back to normal, but a lot of improvement, a moderate amount of improvement, or a little improvement. Patients were enrolled until no new items were cited. Demographic and clinical characteristics were obtained from patient report and chart review. One spine surgeon reviewed all clinical information and assigned diagnoses. Concurrent medical conditions were coded according to the Charlson Comorbidity Index. 12 General physical and mental health were obtained with the self-report SF-12v1. 13 Depressive symptoms were measured with the Geriatric Depression Scale, which is applicable to younger and older adults and addresses psychological symptoms of depression and not somatic symptoms, such as sleep disturbance, which may overlap with neck symptoms. Long-term propensity for anxiety (trait) and short-term reactions to a stressful circumstance (state) were measured with the State-Trait Anxiety Inventory for Adults. 17 Patients reported neck-related limitations with the Neck Disability Index, which has 10 sections addressing various symptoms and difficulty with certain activities, such as reading, lifting, and sleeping. 18, 19 For each section, patients choose among several statements indicating increasing disability with assigned points of 0 (no limitation) to 5 (most limitation). An overall score is the sum of all responses divided by the total possible score and can range from 0% (best condition) to 100% (worst condition). Assessing Expectations Using standard qualitative techniques, 2 assessors independently reviewed all open-ended responses. 20, 21 Through an iterative process, major concepts were identified and grouped into categories, which were then compared with demographic and clinical characteristics with t tests and χ 2 tests. Assembling the Draft Survey Categories that were cited by at least 5% of patients or those that represented potentially unrealistic expectations became the items in the draft survey. Items were worded with phrases typically used by patients when describing their neck condition. The survey begins with the question How much relief or improvement do you expect in the following areas as a result of the treatment for your spine? with response options of back to normal or complete improvement, not back to normal but a lot of improvement, a moderate amount of improvement, a little improvement, and I do not have this expectation or this expectation does not apply to me. Phase 2. Test-Retest of the Draft Survey for Reliability Using the same methods as for phase 1, another group of patients was recruited for the test-retest phase. Patients were given the draft survey twice before surgery several days apart. The first time was during an in-person interview at the time of preoperative testing and the second time was during a telephone interview a few days later. Patients received no interval treatments between interviews. Cronbach α correlation coefficients were calculated for each administration of the survey to establish internal validity. The weighted κ statistic for ranked data was used to measure agreement for each item between surveys. 22 Weighted κ measures concordance above that due to chance and ranges from 1 (perfect disagreement) to + 1 (perfect agreement). The intraclass correlation coefficient for continuous data was used to measure concordance in overall scores for each patient between the first and second administrations of the survey. 23 For both κ values and intraclass correlation coefficients, a value of less than 0.4 is slight to fair agreement, 0.4 to 0.6 is moderate, greater than 0.6 to 0.75 is good, and greater than 0.75 to 1 is excellent agreement. A sample size of 25 patients was used for reliability testing. 24 Phase 3. Selecting Final Items and Scoring An item was retained for the final survey if its κ value was 0.6 or greater or if it had a lower κ value but was commonly endorsed by patients and was considered clinically relevant by consensus of the 4 spine surgeons. A scoring system was developed to Spine 719

3 include both the number of expectations and the amount of improvement expected. The performance characteristics of the survey and associations with clinical characteristics from phase 2 were measured with t tests and χ 2 tests using SAS. 25 RESULTS Phase 1. Identifying Expectations and Developing the Draft Survey In total, 33 consecutive patients were screened between July 2009 and January Of these, 3 were not enrolled because of study personnel schedule and 5 were not enrolled because they were not feeling well enough to participate. Compared with those enrolled, those not enrolled did not differ by sex (44% vs. 50% women, P = 0.77), age (mean age, 55 vs. 51 yr, P = 0.49), or prior spine surgery (16% vs. 13%, P = 0.81). The 25 patients who were enrolled were interviewed in person a mean of 6 ± 3 days before surgery. Their age range was 30 to 79 years, 23 were white, 15 were working full- or part-time, 9 worked 40 or more hours per week, and 11 had professional occupations ( Table 1 ). Seven had work-related disability due to their spine condition and 2 were receiving workman s compensation. About one-third had comorbidity, mostly hypertension (n = 8) and depression (n = 8). According to the psychological scales we administered, 13 had a positive screen for depression and, compared with population norms, 18 had worse state anxiety, 16 had worse trait anxiety, 22 had worse general physical health, and 15 had worse general mental health. The most common primary diagnosis was radiculopathy, the mean duration of current symptoms was 29 months, range 1 to 120 months, and 9 had had prior spine surgery, 4 for the same condition ( Table 2 ). The most common other treatments attempted were epidural injections and physical therapy. Eight patients were currently taking narcotics and 5 additional patients reported that narcotics had been ineffective. In response to the open-ended questions, 10 patients volunteered 2 to 3 expectations, 8 volunteered 4 to 5 expectations, and 7 volunteered 6 to 7 expectations. Patients who were older and had more depressive symptoms volunteered more expectations ( P < 0.05), but there were no differences based on sex, education, anxiety, Neck Disability Index scores, or duration of symptoms. In total, patients volunteered 104 expectations and rated amount of improvement expected as complete improvement or back to normal for 79 expectations (76%). Expectations then were grouped into 31 main categories addressing improvement in pain, numbness, hand movement, personal and work activities, and psychological distress. These categories were sequenced according to similar concepts and became the items for the draft survey. Phase 2. Test-Retest of the Draft Survey for Reliability Another group of 34 patients was screened from February 2010 to August Of these, 9 were not enrolled because of study personnel schedule (n = 5) and patient refusal (n = 4). Compared with those enrolled, those not enrolled did not differ by sex (44% women in both groups), age (mean age, TABLE 1. Demographic and Clinical Characteristics Characteristics Phase 1 (n = 25) Phase 2 (n = 25) Age, yr (mean ± SD) 55 ± ± 15 Women 44% 44% Marital status Married 84% 80% Separated/divorced 8% 8% Widowed 4% 0% Never married 4% 12% Education Less than college 48% 20% Graduated college 12% 36% Graduate school 40% 44% Work status Working full-time 48% 48% Working part-time 12% 8% Disability due to spine 28% 16% Other 12% 28% Quite a bit or as much help at home 76% 96% as wanted Body mass index 30 kg/m 2 40% 32% Smoking status Current smoker 8% 8% Past smoker 36% 20% Moderate alcohol use 60% 52% Comorbidity* 0 64% 76% 1 16% 16% 2 20% 8% Depressive symptoms (mean ± SD) 10 ± 7 9 ± 8 Positive screen for depression 52% 36% State anxiety (mean ± SD) 42 ± ± 9 Above population norm 72% 68% Trait anxiety (mean ± SD) 38 ± 9 35 ± 11 Above population norm 64% 36% General physical status (mean ± SD) 33 ± 9 35 ± 10 General mental status (mean ± SD) 44 ± ± 14 *Charlson Comorbidity Index, weighted scale according to number of major conditions. Geriatric Depression Scale, possible score 0 30, higher is more depressive symptoms, 11 is positive screen for depression. State-Trait Anxiety Inventory for Adults, possible score 20 80, higher is more anxiety. SF-12v1, possible score 0 100, higher is better status, 50 is general population norm April 2013

4 TABLE 2. Variables Associated With Spine Condition Variables Phase 1 (n = 25) Phase 2 (n = 25) Diagnosis (primary) Radiculopathy 76% 64% Myelopathy 20% 24% Previous surgery with failed 4% 12% fusion (nonunion) Prior surgery for this condition 16% 20% Prior treatments for this condition Epidural corticosteroid injections 40% 36% Physical therapy 56% 56% Acupuncture 24% 4% Chiropractic care 28% 12% Current analgesics Nonsteroidal anti-inflammatory 40% 48% drugs Narcotics 32% 40% How long aware of neck problem, months, median Duration of current exacerbation, months, median Self-report neck symptoms and function score (mean ± SD)* 47% ± 20% 41% ± 21% *Neck Disability Index, range 0% 100%, reported as percent of worst possible score. 55 vs. 59 yr, P = 0.44), or prior spine surgery (20% vs. 13%, P = 0.64). The 25 participating patients found the survey acceptable and were willing to participate both times ( i.e., no attrition) and there were no incomplete surveys. The first interview occurred a mean of 6 ± 2 days before surgery and the second interview occurred a mean of 5 ± 1 days later. Compared with phase 1, patients in phase 2 had less education, less comorbidity, and were less likely to have tried other treatments ( Tables 1 and 2 ). The 31 items in the draft survey were endorsed by 48% to 96% of patients and κ values ranged from 0.23 to 1.0. Phase 3. Selecting Final Items and Scoring Of these 31 items, 21 items were retained to form the final survey ( Table 3 ). Items were retained if their κ values were 0.6 or greater or if they were frequently endorsed by patients and were considered clinically relevant by consensus of the surgeons. Several items addressed similar concepts and were highly correlated and were combined ( i.e., improve ability to write and use hands for fine activities and reduce emotional stress and sad feelings). The original terminology for each item was maintained in the combined items in the final TABLE 3. Frequency of Endorsement and Weighted κ Values for Expectations Retained in the Final Survey Expectations Frequency (%) Weighted κ Relieve neck pain Relieve shoulder, arm, or hand pain Relieve symptoms that interfere with sleep Improve strength in arms and hands Relieve numbness in arms and hands Improve ability to push or pull Improve ability to use hands for fine activities (such as button a shirt, write) Improve ability to position head to read Improve ability to manage personal care (such as comb hair, brush teeth, shave) Improve ability to drive Remove need for pain medications Improve ability to interact with others (such as social and family activities) Improve sexual activity Improve ability to perform daily activities (such as chores, shopping, errands) Improve ability to participate in sports If currently employed: fulfill job responsibilities (such as, work required hours, complete expected tasks) 71* 0.78 If currently work-disabled or unemployed due to spine: go back to work for salaried employment Reduce emotional stress or sad feelings Stop my spine condition from getting worse Remove the control my spine condition has on my life *Among the total currently employed. Among the total currently unemployed. survey. Several employment-related expectations were difficult to discern because they could not be applied uniformly to employed and unemployed individuals. We decided to delete these items and to retain only 2 work-related items that were mutually exclusive; 1 addressing expectations for those work disabled and 1 addressing expectations for those Spine 721

5 still employed. The employment items that were deleted were clustered; thus, the order of the items in the final survey parallels the order in the tested survey. The final wording of items was determined with input from surgeons and patients. The final Cervical Spine Surgery Expectations Survey of Hospital for Special Surgery is composed of these 21 items with response options for each item reflecting amount of improvement expected ( Figure 1 ). The survey is scored by ranking responses from 4 points for complete improvement, back to normal to 0 points for I do not have this expectation or this expectation does not apply to me. The 2 employment items are mutually exclusive, thus a maximum of 20 items applies to any patient. An overall score is calculated as the sum of all responses (raw score) divided by the maximum possible score (4 20 = 80) ( Figure 2 ). Thus, the possible score range is 0 to 100 and a higher score indicates greater expectations. The responses were formatted to allow patients the option of reporting that they do not have a particular expectation or that the expectation does not apply to them. Therefore, blanks or missing data should me minimal. Additional testing to determine a clinically important difference will inform the selection of the threshold number of responses required to score the survey. If there are blanks and the threshold number of items has been met, then the survey should be scored by adjusting the devisor from 20 items to the number of items actually answered. If the threshold is not met, then a score should not be calculated but each item can still be reported descriptively because each item underwent independent test-retest analysis with the κ statistic. When applied to the 2 survey administrations in phase 2, the mean scores were 58 ± 22 and 57 ± 27. Each set of scores approximated a normal distribution with ranges of 19 to 100 and 13 to 100, with only 1 patient from each administration having the maximum score. Cronbach α coefficients were 0.90 and 0.93, and the intraclass correlation coefficient between scores was In preliminary analysis from phase 2, greater expectations were associated with worse state anxiety, Figure 1. Final survey with expectations items and response options April 2013

6 Figure 2. Recommended scoring instructions. general mental health, and worse disability as reflected by worse Neck Disability Scale scores ( P < 0.05). Also, patients with radiculopathy had higher mean overall scores, that is, more expectations (61) than patients with myelopathy (47). Expectations did not differ on the basis of age, sex, depressive symptoms, or education. DISCUSSION We developed an expectations survey for patients undergoing cervical spine surgery that addresses symptoms of pain and numbness as well as physical limitations and psychological wellbeing. The survey was developed from interviews with patients and items were selected on the basis of psychometric performance and their relevance to actual clinical practice. An overall score can be calculated and is based on amount of improvement expected. This survey is unique in that it is patient-derived and offers a standardized way to preoperatively acknowledge patients physical and psychological expectations. This study was carried out with the same methodology we used for the successful development of other orthopedic expectations surveys. 4 7 The cornerstone of this methodology is to derive items for the survey that are based on patients perspectives and not from a priori perspectives of clinicians. This is an important distinction because patient-derived surveys potentially can include unrealistic expectations ( i.e., complete improvement) or expectations that are seemingly remote from the physical condition ( i.e., improvement in psychological well-being), whereas clinician-derived surveys typically have expectations that are potentially achievable and focus on symptoms and functional manifestations of the condition. Thus, patient-derived surveys have face and content validity because they reflect the circumstances and Spine 723

7 points of view of the intended population. One example of this is from our prior orthopedic expectations surveys where patients with an acute injury ( e.g., torn knee anterior cruciate ligament) often expected that surgery would return them to the way they were before this problem started compared with patients with knee osteoarthritis undergoing arthroplasty who rarely expressed this expectation. Examples of expectations specific to patients with cervical spine conditions from this study include expectations to improve hand function and to position the head to read. In addition to content validity for patients, in our studies surgeons reviewed the final survey to verify that it reflects what surgeons encounter in the clinical setting and thus has content validity for clinicians. Other psychometric properties were also addressed during the development of the survey. Specifically, we found that the survey has construct validity because it reflects greater expectations in those most disabled and thus potentially those with the most items to expect. We also found preliminary evidence that the survey has discriminative validity by distinguishing between patients with a primary diagnosis of radiculopathy versus myelopathy; this latter finding will require testing in larger samples for confirmation. Larger samples will also be required to determine whether items are clustered psychometrically in addition to their obvious clinical associations. Only several other studies addressed expectations in patients undergoing cervical spine surgery. For the most part, these studies focused on only a few broad categories of expectations, such as relief of pain, return to work, and improvement in social activities. 1, 3, 26 This generalized approach, however, does not address the true complexity of patients experiences. 26 Therefore, other investigators attempted to capture more expectations. For example, in one study of idiopathic scoliosis, investigators assembled 9 expectations addressing pain relief; ability to sleep better; ability to participate in home, school, recreational, and sports activities; current attitude toward oneself; and proactive amelioration of future pain and disability. 27 A total of 91 patients preoperatively were asked whether they had these expectations with response options ranging from definitely yes to definitely no. Most patients endorsed all items. In another recent study, investigators used a modified version of the cervical spine expectations section of the Musculoskeletal Outcomes Data Evaluation and Management System questionnaire. 28 Preoperatively, patients were asked how likely they thought they were to have relief from pain and to be able to do everyday activities, sleep more comfortably, exercise and participate in recreational activities, return to work, and to prevent future disability. Response options ranged from extremely likely to not at all likely; most patients thought that they were extremely or very likely to have these improvements. Although it is generally acknowledged that expectations should be assessed preoperatively and not retrospectively, some studies have asked patients to assess their postoperative condition in terms of their recalled expectations. For example, in one study, patients postoperatively were asked how the actual results of surgery compared with their expectations; response options ranged from much better to much worse. 29 Our study is similar to other studies that included preventing future deterioration as an expectation. In the scoliosis study cited previously, avoiding future disability had the highest expectation rating. 27 In the study that used the Musculoskeletal Outcomes Data Evaluation and Management System questionnaire cited previously, preventing future disability was considered extremely likely or very likely by most patients. 28 In our study, more than 90% of patients expected that surgery would prevent their spine condition from getting worse. Thus, unlike other expectations that are based on actual experience and current condition, this expectation is derived from other types of knowledge. Future analyses probing the etiology of this expectation would be interesting from the point of view of sources of information and topics for patient education. The expectations survey can be used to enhance education and clinical interactions in other ways as well. For example, understanding expectations helps clinicians direct education toward topics that are most important and consequential to patients. These discussions can also help ensure that the patient and physicians are working toward the same goals and that expectations are realistic for that patient. Unrealistic expectations are undesirable because they may ultimately impact outcome. For example, inappropriately high expectations may predispose to dissatisfaction with outcome if patients become discouraged or disappointed with their degree and rate of recovery. Expectations that are too low, on the contrary, may also predispose to poor outcomes if patients lack the necessary motivation to participate in postoperative rehabilitation and to follow necessary postoperative precautions. Another strength of the expectations survey is that it is formatted so that it potentially could be used as an outcome measure. Specifically, after surgery if patients are asked how much improvement they obtained for each item and this is compared with how much improvement they expected, then the degree of agreement is a measure of fulfillment of expectations. Fulfilling expectations is an important objective of spine surgery and having a valid method to measure this would contribute to the comprehensive assessment of outcomes of spine surgery. However, additional studies are needed to delineate the performance characteristics of the survey if it is to be used as an outcomes instrument. We found an association between psychological state and expectations. In particular, patients with more depressive symptoms, worse anxiety, and worse general mental health had more expectations. These findings are preliminary, as we did not have large enough sample sizes for subanalyses. However, taken collectively, these results provide early support for our survey s ability to capture nuances of expectations according to psychological variables. This topic merits further investigation because another recently completed study did not find an association between expectations and general mental health. This latter study prospectively asked 79 patients undergoing cervical discectomy and fusion what they expected their neck and arm pain to be 1 year after surgery using visual analogue scales. 26 The investigators did not find differences in general mental health scores between patients expecting complete resolution of pain and those expecting April 2013

8 some resolution of pain. However, this study was limited in that pain was the only expectation considered. Our study has several limitations. First, patients were enrolled from a tertiary care orthopedic referral center, and their expectations may differ from other patients in different settings. Second, the sample size was based on the number of patients needed to develop the survey and all subgroup analyses are preliminary. Larger samples are needed to ascertain sensitivity of the survey to distinct demographic and clinical features. Larger samples are also needed to delineate relationships among survey items with a formal factor analysis. Third, this survey was developed and tested in surgical patients and its applicability to nonoperative patients is not known. In conclusion, we developed a valid and reliable patientderived expectations survey for patients undergoing cervical spine surgery. The survey addresses symptoms, physical function, and psychological well-being and generates an overall score that is easy to interpret. This survey is clinically relevant and useful for research and fills a gap in the comprehensive preoperative assessment of patients undergoing cervical spine surgery. Key Points We developed a 21-item valid and reliable patientderived expectations survey for patients undergoing cervical spine surgery. The survey addresses symptoms, physical function, and psychological expectations, and an overall score can be calculated. The survey can be used clinically and for research. Acknowledgment The authors thank Shanti K. Leon Guerrero, BA, for her assistance with the qualitative analysis. References 1. Davidson D, Noonan VK, Dvorak MF, et al. The impact of patient expectations on outcome following treatment for spinal trauma. Spine 2010 ; 35 : Linton SJ. A review of psychological risk factors in back and neck pain. 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