Patient Reported Allergies Are a Risk Factor for Poor Outcomes in Total Hip and Knee Arthroplasty

    Patient Reported Allergies are a Risk Factor for Poor Outcomes in Total Hip and Knee Arthroplasty Christopher Graves MD, Jesse Otero MD, PhD, Yubo Gao PhD, Devon Goetz MD, Melissa Willenborg MD, John Callaghan MD PII: DOI: Reference:

S0883-5403(14)00351-9 doi: 10.1016/j.arth.2014.02.040 YARTH 54006

To appear in:

Journal of Arthroplasty

Received date: Revised date: Accepted date:

4 October 2013 22 January 2014 6 February 2014

Please cite this article as: Graves Christopher, Otero Jesse, Gao Yubo, Goetz Devon, Willenborg Melissa, Callaghan John, Patient Reported Allergies are a Risk Factor for Poor Outcomes in Total Hip and Knee Arthroplasty, Journal of Arthroplasty (2014), doi: 10.1016/j.arth.2014.02.040

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ACCEPTED MANUSCRIPT Title:

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Patient Reported Allergies Are a Risk Factor for Poor Outcomes in Total Hip and Knee Arthroplasty

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Authors:

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Christopher Graves, MD1 Jesse Otero, MD, PhD1 Yubo Gao, PhD1 Devon Goetz, MD2 Melissa Willenborg, MD1 John Callaghan, MD1

Institutions:

Department of Orthopaedics and Rehabilitation University of Iowa Hospitals and Clinics Iowa City, Iowa

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Des Moines Orthopaedic Surgeons West Des Moines, Iowa

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Please address all correspondence to : Christopher Graves, MD Department of Orthopaedics and Rehabilitation University of Iowa Hospitals and Clinics 200 Hawkins Rd Iowa City, IA 52242 Phone (319) 356-2595

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Abstract: We evaluated 459 patients undergoing THR or TKR who completed preoperative and

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postoperative WOMAC and/or SF36 surveys. Medical comorbidities and reported

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allergies were also recorded. Evaluation of surveys was compared for patients with or without 4 or more reported allergies using ANOVA and regression analysis. Patients

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with 4 or more reported allergies had less improvement on SF36 Physical Component

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Score (∆PCS avg +4.2) than those with 0-3 allergies (∆PCS avg +10.0, p = 00002). Regression analysis showed that this change was independent of self-reported

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comorbidities. Patients reporting 4 or more allergies also had less improvement in WOMAC function (∆F avg 21.4) than those with 0-3 allergies (∆F = 27.2 p = 0.036).

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Similar non significant trends occurred in SF36 mental and WOMAC pain and stiffness

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scores.

Introduction:

Patient reported dissatisfaction rates following elective total hip and knee arthroplasty range from 9% for THA to as high as 20% for TKA [1-3]. Numerous investigators are researching the factors associated with dissatisfaction following joint replacement. [1-6]. It is the authors’ observation that that patients with multiple reported allergies tend to be clinically challenging patients and less satisfied with their procedure. We hypothesized that patients with multiple reported allergies report higher rates of dissatisfaction following TKR and THR. The purpose of this study is to compare patient reported

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ACCEPTED MANUSCRIPT outcomes following total joint arthroplasty in patients with and without multiple reported

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allergies in their medical record.

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Materials and methods:

Institutional Review Board approval was obtained for this study. Patients undergoing

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total joint arthroplasty at our institution are asked to complete a series of questionnaires

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which include self-reported medical comorbidities, demographic information, as well as outcome measures including 36-Item Short Form Health Survey (SF-36) score and

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Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores. At their first clinic visit, patients are also asked about “allergies” and their answers are recorded

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in the medical record. At postoperative visits, the SF-36 and WOMAC outcome

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measures are repeated. When patients submitted more than one survey in one of the analyzed time periods, their scores were averaged. In the circumstance where bilateral

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joint replacement was performed, the average pain in both joints was used both

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preoperatively and post operatively.

The cohort for our study was the group of patients undergoing primary elective total joint arthroplasty of the hip or the knee who completed a paired pre-operative and postoperative assessment. In the interval from 2009 to 2010, we identified 459 patients from four surgeons at a single academic institution who completed either (459) or both (383) of a pair of preoperative (average 6.5 months) and post operative (average 10.4 months) survey instruments.

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ACCEPTED MANUSCRIPT Both the SF36 and WOMAC were separated into subscores for the purposes of comparison. Subscores for the SF36 include Physical Component Summary (PCS) and

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Mental Component Summary (MCS). The WOMAC index subscores include Pain,

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Stiffness, and Functional limitation. Self-reported comorbidities were obtained using a custom survey instrument, following which a semi-quantitative comorbidity index was

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calculated based upon the number of comorbidities reported.

Patient allergies were obtained from a review of the electronic medical record (EPIC). At

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our institution, allergy data is predominately self-reported by patients and recorded and entered into EPIC by nurses, medical assistants and primary care providers. Allergies are

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routinely reviewed with the patient at all clinic visits, but are rarely formally audited or

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Statistical Analysis

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resolved.

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A Χ2 analysis for correlation was performed to look for relationships between dependent variables (change in PCS and MCS from the SF36, and function, pain and stiffness from the WOMAC) and potential independent variables identified in the medical record (surgeon, sex, age at surgery, drug alcohol treated, smoking status at time of surgery) from the EMR data. None of these reached statistical significance.

Comparisons between preoperative and post operative SF-36 MCS and PCS scores and the change in the WOMAC function, pain and stiffness scores were compared to the total number of allergies. The differences in the group scores were analyzed with the student’s

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ACCEPTED MANUSCRIPT t-test. P values less than 0.05 were considered statistically significant. Analysis of Variance (ANOVA) and regression analysis were performed to examine the data for

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potential confounding sources of variance in outcome measures such as number of

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comorbidities. The data was considered to be unbalanced for statistical purposes. The calculation was performed with Type III sums of squares to conservatively evaluate for

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the presence of an allergy effect after the other effect interaction with the co-morbidity

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survey.

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Results

Paired data including (pre and post op) for either WOMAC or SF36 PCS MCS was

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available in 459 patients who met our inclusion criteria, 383 of which had both surveys.

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Our cohort’s mean age was 59.6 (+/- 11.0) years, and showed a slight predilection toward female sex (61%), which are similar demographics to estimates of the epidemiology of all

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patients undergoing total joint arthroplasty in the United States. [7] All patients were

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fairly evenly divided between those undergoing total hip (47%) and total knee (53%) arthroplasty. Similar equivocal distribution was noted with regard to sidedness of the procedure (52% right, 46% left, 2% bilateral). The mean BMI for all groups was obese (33.5, σ 15.1). Seventy-five percent of patients had not smoked cigarettes in the 6 months prior to surgery, 13% were actively smoking at the time of surgery.

Our 459 patients reported 203 different allergies, with an average of 1.69 (σ 0.11) allergies per patient. The most commonly listed allergies were Penicillins (9.4% of patients), Sulfonamide antibiotics (7.3% of patients), and codeine (5.5% of patients). A

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ACCEPTED MANUSCRIPT complete list of the most common allergies reported is included in Table 1. Thirty-six percent of our patients reported no allergies, while 14% reported 4 or more allergies. At

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than 12 different substances in their medical record.

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the extreme end of the data set, there were eight patients each reporting allergies to more

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A general association between number of reported allergies and worse outcome as

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measured using our survey instruments was noted consistently through the data set. To help further delineate this difference, the patients were subdivided into groups with

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increasing numbers of allergies, and multiple stepwise comparisons were made to determine the threshold at which a patient is likely to have a statistically worse outcome.

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We found that in our population, the 14% of patients with 4 or more allergies had

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diminished improvements in their post operative PCS component of SF36 and Function component of WOMAC that reached statistical significance. (Table 2). Similar non-

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significant trends were noted in all other categorical variables.

To control for the possibility of the variance being driven by increasing medical comorbidity, a regression analysis and analysis of variance was performed to analyze the relationship of allergy and outcome independent of co-morbidity. Even after removal of this confounder, the results in the most disparate group (0-3 vs 4+) showed that physical component score of the SF36 remained independent of comorbidities, indicating a high probability (p = .002) that that the null hypothesis is true. This result indicates a high likelihood that number of allergies contributes significantly to the variance and the result is not simply a surrogate for comorbidities.

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Discussion

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Total joint arthroplasty remains one of the most effective procedures in modern medicine.

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Most patients have a positive outcome following surgery in terms of relief of pain and improvement of quality of life. [1-6] Despite this, certain patients are inevitably

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dissatisfied following elective TKA and THA, ranging from 9 to 20%.[1-3] In the push

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towards a healthcare system based on measures of “quality”, government organizations and insurers are considering payments to hospitals and surgeons based on patient reported

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satisfaction. It was the authors’ observation that patients with multiple allergies tend to be clinically challenging patients and less satisfied with their procedure. Several recent

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studies have reflected many factors in mental health to be significant predictors of post

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operative outcome. [6,8,9] It is our hypothesis that the subset of patients who reports

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multiple allergies may represent a similar at risk population.

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The phenomenon of allergy in the medical record is somewhat of a misnomer. [10] Many of the listed allergies were likely simply Adverse Drug Reactions (ADR’s). An ADR is defined as a noxious, unintended and undesired side effect of a drug that occurs at doses used for prevention, diagnosis and treatment. [11] Rawlins and Thompson further subdivided ADR’s into two categories, Type 1, which is a common and predictable reaction to medication, and Type 2, which is a drug mediated hypersensitive reaction. [12] A true IgE mediated histamine response to a medication was found to be a minority of reported allergies in previous studies.[10,13]

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ACCEPTED MANUSCRIPT Geisinger et al, [14] and others have asserted that outcomes measures may largely be influenced by elements other than mechanical and biomedical factors, such a patients

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psyche. [6,8,9] Several studies have also shown poorer outcomes based on these surveys

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in patients with depression and anxiety[9], or those with a negative outlook towards surgery. [6] Concurrently in the psychiatry literature, there has also been shown an

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association with “false” allergy reporting and Axis I psychiatric disorders such as major

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depression, mood, and anxiety disorders.[15] Our data suggests multiple reported allergies may be a surrogate for other mental health surveys in identifying patients at risk

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for poor perceived outcomes following a total joint arthroplasty.

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An increased number of medical comorbidities is also associated with a poorer

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outcome[16], and an alternate hypothesis suggests patients with more comorbidities might have greater exposure to the healthcare system and are thus a greater risk of

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developing adverse drug reactions by the nature of having been treated with more drugs.

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We attempted to account for this confounding variable with our regression analysis, which showed a statistically significant change of SF36 PCS independent of number of comorbidities, and a similar trend in WOMAC function, although it did not reach significance. This suggests that increasing number of allergies is not simply a surrogate for exposure to the healthcare system, but represents a true risk factor for poor outcomes.

Our study was limited by several important factors. First, the retrospective nature of the study limited our data to that available on chart review. All data were gathered in the context of patient care, and therefore, scheduled follow-ups for uniform data collection

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ACCEPTED MANUSCRIPT were not available. In addition to this limitation, allergy information was obtained from an EMR record in a University based large multispecialty group. The allergy data is

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predominately self reported by the patients and recorded and entered into EPIC by nurses,

that allergies are rarely resolved in the EMR.

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medical assistants and by primary care providers. It is the authors’ personal experience Finally, our small sample size limits the

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statistical power of our study, and therefore increases the likelihood of making a type II

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error.

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Conclusion

Patients with multiple reported allergies belong to a group with a statistically significant

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lower functional status after hip and knee replacement per WOMAC and SF36. Patients

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with self reported allergies have lower pre operative levels of function and can as a whole expect less improvement than their peers without multiple allergies. Patients and

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physicians should be aware of this relationship and identify and optimize other risk

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factors for poor outcome. The authors are presently studying THA and TKA patients in larger numbers prospectively to further evaluate the continuum of multiple allergies, mental health, and poor outcomes in arthroplasty.

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ACCEPTED MANUSCRIPT References:

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1. Noble, P. C., Conditt, M. A., Cook, K. F., & Mathis, K. B. (2006). The John Insall Award: Patient Expectations Affect Satisfaction with Total Knee Arthroplasty. Clinical Orthopaedics and Related Research®, 452, 35–43.

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2. Bourne, R. B., Chesworth, B. M., Davis, A. M., Mahomed, N. N., & Charron, K. D. J. (2009). Patient Satisfaction after Total Knee Arthroplasty: Who is Satisfied and Who is Not? Clinical Orthopaedics and Related Research®, 468(1), 57–63.

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3. Anakwe, R, Jenkins, P, Moran, M (2011). Predicting Dissatisfaction After Total Hip Arthroplasty: A Study of 850 Patients. Journal of Arthroplasty, 26(2), 209–213.

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4. Perruccio AV, Davis AM, Hogg-Johnson S, Badley EM. Importance of self-rated health and mental well-being in predicting health outcomes following total joint replacement surgery for osteoarthritis. In: Arthritis Care Res. 973. 2011

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5. Scott CE, Howie CR, MacDonald D, Biant LC. Predicting dissatisfaction following total knee replacement: a prospective study of 1217 patients. J Bone Joint Surg Br. 2010;92:1253–8

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6. Lavernia, C, Alcerro, J, Brooks, L, Rossi, M. (2012). Mental Health and Outcomes in Primary Total Joint Arthroplasty. Journal of Arthroplasty, 27(7), 1276–1282.

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7. Jain, N. B., Higgins, L. D., Ozumba, D., Guller, U., Cronin, M., Pietrobon, R., & Katz, J. N. (2005). Trends in epidemiology of knee arthroplasty in the United States, 19902000. Arthritis & Rheumatism, 52(12), 3928–3933.

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8. Perruccio, A. V., Davis, A. M., Hogg-Johnson, S., & Badley, E. M. (2011). Importance of self-rated health and mental well-being in predicting health outcomes following total joint replacement surgery for osteoarthritis. Arthritis Care & Research, 63(7), 973–981. 9. Stundner, O., Kirksey, M., Chiu, Y. L., Mazumdar, M., Poultsides, L., Gerner, P., & Memtsoudis, S. G. (2013). Demographics and Perioperative Outcome in Patients with Depression and Anxiety Undergoing Total Joint Arthroplasty: A PopulationBased Study. Psym, 54(2), 149–157. 10. MacPherson, R. D., Willcox, C., Chow, C., & Wang, A. (2006). Anaesthetist“s responses to patients” self-reported drug allergies. British Journal of Anaesthesia, 97(5), 634–639. 11. World Health Organisation. International drug monitoring: the role of the hospital. World Health Organ Tech Rep Ser 1969; 425: 5–24

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ACCEPTED MANUSCRIPT 12. Rawlins MD, Thompson W. Mechanisms of adverse drug reactions. In: Davis DM, ed. Textbook of Drug Reactions. New York, NY: Oxford University Press, 1991; 18– 45

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13. Chen, C. J., Cheng, C. F., Lin, H. Y., Hung, S. P., Chen, W. C., & Lin, M. S. (2012). A comprehensive 4-year survey of adverse drug reactions using a network-based hospital system. Journal of Clinical Pharmacy and Therapeutics, 37(6), 647–651.

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14. Giesinger, J. M., Kuster, M. S., Behrend, H., & Giesinger, K. (2013). Association of psychological status and patient-reported physical outcome measures in joint arthroplasty: a lack of divergent validity. Health and Quality of Life Outcomes, 11, 64.

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15. Patten SB, Williams JVA. Self-reported allergies and their relationship to several Axis I disorders in a community sample. In: Int J Psychiatry Med. 11. 2007

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16. Singh, J. A., & Lewallen, D. G. (2013). Medical and psychological comorbidity predicts poor pain outcomes after total knee arthroplasty. Rheumatology, 52(5), 916–923. doi:10.1093/rheumatology/kes402

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ACCEPTED MANUSCRIPT Table 1: Frequency Distribution of Most Commonly Reported Allergies Identified Allergy Frequency

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Allergies listed (TOTAL)

73 57 43 33 28 26 21 19 19 18 17 16 15 13 12 10 9 8 7 7 7 7 6

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Penicillins Sulfa (sulfonamide antibiotics) Codeine Other agent Oxycodone Morphine Adhesive Acetaminophen Amoxicillin Latex Hydrocodone Aspirin Cephalexin Iodine Tramadol Meperidine Ibuprofen Naproxen Celecoxib Clarithromycin Non-med tape Unclassified drug Erythromycin

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Listed allergies (unique types) 203 The top listed 23 allergies (of 203 total types of allergies) accounted for 471 or 61% of the total listed allergies.

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TABLE 2. Results of Outcomes Surveys for Allergy Cohorts

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40.6(1.3) 22.1 (1.3)

29.3 (1.1)

p=0.04

48.3(1.5) 43.4(3.2) 35.8 (2.7)

4.2 (1.77)

p=0.0002 1.2 (1.3)

35.7 (4.0)

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4+ Allergies PreOperative 4+ Allergies (delta)

2.5 (0.5)

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0 to 3 Allergies PreOperative 0 to 3 10.0 Allergies (0.6) (delta)

WOMAC Pain Stiffness Function 46.9(1.1) 41.4 45.5 (1.1) (1.0)

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MCS 49.4 (0.6)

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SF 36 PCS 30.7 (0.4)

24.3 (4.0)

27.3(1.1)

39.8 (2.4)

p=0.002

21.4 (3.4)

p=0.04

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PCS indicates physical components score: MCS indicate mental components score. Delta compares the preoperative to post operative groups Numbers in parentheses arc mean standard error. Statistically significant compairisons arc shown in bold with p values where significant, p value compares the 4+ allergy group to the 0 to 3 allergy group

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