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Preoperative opioid medication use negatively affect health related quality of life after total knee arthroplasty
THEKNE-02662; No of Pages 6 The Knee xxx (2018) xxx–xxx
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The Knee
Preoperative opioid medication use negatively affect health related quality of life after total knee arthroplasty John Paul M. Manalo, Tiffany Castillo, David Hennessy, Yun Peng, Brian Schurko, Young-Min Kwon ⁎ Department of Orthopaedic Surgery, Massachusetts General Hospital, Harvard Medical School, USA
a r t i c l e
i n f o
Article history: Received 10 April 2018 Received in revised form 9 June 2018 Accepted 2 July 2018 Available online xxxx Keywords: Health related quality of life Total knee arthroplasty Patient reported outcomes Preoperative opioid
a b s t r a c t Background: Opioids are commonly prescribed to treat patients suffering from painful knee arthritis. However, the opioid epidemic in the United States constitutes a major public health concern. This study aims to characterize the effect of preoperative opioid use on patientreported outcome measures (PROMs) after total knee arthroplasty (TKA). Methods: PROMs collected from patients undergoing TKA were reviewed. We identified two matched cohorts: (1) 30 patients who used opioids preoperatively and (2) 137 patients who did not use opioids preoperatively. The non-opioid cohort was carefully selected to match the opioid cohort. Statistical analyses were performed to determine the difference in demographics, PROMs, length of stay, disposition and co-morbidities between the two cohorts. Results: The non-opioid users had significant improvement in both EuroQol5D (EQ-5D) PROMs and visual analogy scale (VAS) scores postoperatively (p b 0.001); however, preoperative opioid users did not show improvement in either measure. University of California Los Angles (UCLA) scores were significantly improved for both non-opioid users (p b 0.001) and opioid users (p b 0.001). Non-opioid users had higher preoperative EQ-5D scores than opioid users (p = 0.02). There was no difference in range of motion, length of stay, or disposition between cohorts. Conclusion: Our results demonstrated that TKA patients with preoperative opioid use had significantly lower VAS scores and trends of lower UCLA and EQ-5D scores postoperatively compared to non-opioid patients, suggesting the use of opioid medications prior to TKA negatively affects patient reported outcomes following surgery. The current findings provide useful clinical information that can be used in counseling patients prior to undergoing TKA. © 2018 Elsevier B.V. All rights reserved.
1. Introduction Knee arthritis is a significant cause of pain and decreased mobility, which can contribute to a poor quality of life. Treatment modalities for knee arthritis include physical therapy, anti-inflammatory drugs, walking aids, knee braces, opioid pain medications, and surgical intervention. Prescription opioids have long been used for the treatment of knee arthritis and the number of patients taking opiates who present to orthopedic surgeons for knee replacement continues to increase. Prescription opioid abuse is a major public health crisis. In 2013, there were an estimated 1.9 million individuals who were dependent or abused opioid pain medication [1]. Furthermore, from 1999 to 2015, the Centers for Disease Control and Prevention (CDC) estimated that there were over 183,000 deaths in the United States related to prescription opioid use in 2014 [2, 3]. Bedard et al. reported on
⁎ Corresponding author at: Department of Orthopaedic Surgery, Massachusetts General Hospital, Harvard Medical School, 55 Fruit St, Yawkey Suite 3B, Boston, MA 02114, USA. E-mail address: [email protected]. (Y.-M. Kwon).
https://doi.org/10.1016/j.knee.2018.07.001 0968-0160/© 2018 Elsevier B.V. All rights reserved.
Please cite this article as: Manalo JPM, et al, Preoperative opioid medication use negatively affect health related quality of life after total knee arthroplasty, Knee (2018), https://doi.org/10.1016/j.knee.2018.07.001
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patients using opioid pain medication within three months prior to total knee arthroplasty (TKA) during an eight-year period. Nearly one-third of their cohort used preoperative opioids and the percentage increased nine percent during the study period [4]. Wright et al. showed nearly 40% of patients with knee osteoarthritis received at least one opioid prescription in 2009. This percentage increased from 31% in 2003 [5]. Previous studies have shown worse outcomes in joint arthroplasty in patients who used opioids preoperatively. These studies have shown increased in-hospital complications, increased length of stay, prolonged narcotic use, and increased postoperative opioid consumption after total joint arthroplasty in patients who preoperatively used opioid pain medication [6–14]. However, there is a paucity of data regarding patient reported outcomes after total knee arthroplasty in patients who use opioid pain medication prior to surgery. Recently, Smith et al. showed preoperative opioid users had less pain relief using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score and the Pain Catastrophizing Scale [15]. To our knowledge, no study has compared the health-related quality of life (HRQoL) changes following TKA between opioid naïve patients and patients who use opioids preoperatively using the EuroQol5D (EQ-5D). The EQ-5D is a validated non-disease specific, preference-based, standardized instrument used to measure general health outcomes [16]. The purpose of this study was to compare the EQ-5D HRQoL measures after total knee arthroplasty in patients who used preoperative opioids vs. those who were opioid naïve.
2. Methods 2.1. Patients Institutional review board (IRB) approval was obtained for a retrospective review of patients in our hospital medical registry who underwent TKA with completed EQ-5D index scores, visual analog scale (EQ VAS) general health scores, and University of California Los Angles (UCLA) activity scores. The charts of these patients were reviewed and cohorts were separated based on preoperative opioid use. To obtain information regarding opioid use, we reviewed the electronic medical record of each qualifying patient. The presence or absence of opioid medications documented in preoperative clinic visit notes, the primary care provider notes or medication lists was used to classify the patients. We identified two cohorts of patients: (1) 137 patients who did not use opioids preoperatively and (2) 30 patients who used opioids prior to TKA. The non-opioid cohort was carefully selected to match the opioid cohort utilizing selection criteria which were decided upon before data collection. During chart review, one of the study authors carefully selected matched control patients for each opioid patient, with age difference less than 10 years, same sex and body mass index (BMI) difference less than five kilograms per square meter. More than one matched control subject for the same opioid user was allowed. Patient outcomes were collected preoperatively at 184 [496] days (median, [interquartile range]) and 166 [531] days for users and non-users, respectively (p = 0.67), and postoperatively at 519 [222] days and 352 [251] days for users and non-users respectively (p = 0.042).
2.2. Power analysis Prior to data collection, a statistical power analysis was performed for sample size estimation. Due to the lack of reports of the EQ-5D scores in the opioid user population, we relied on the study by Smith et al. [15], who compared another outcome variable WOMAC score at six-month follow-up between 36 preoperative opioid users and 120 non-users (mean ± standard deviation) (27.0 ± 4.3 vs. 33.6 ± 2.3, p = 0.008) with TKA. The effect size of this study was 1.91 (Cohen's d) and considered large according to Cohen's criteria [17]. Using their data, with an alpha = 0.05, power = 0.80 and the same sampling ratio, the projected sample size needed is approximately nine opioid users and 25 non-users. As a reference, the minimal clinically important difference is 0.16 for the EQ-5D score and 22 for the WOMAC score [18]. A statistical power analysis was performed for sample size estimation, based on published data from a similar study by Smith et al. that compared the changed WOMAC score from preoperative to six-month follow-up between 36 preoperative opioid users and 120 non-users (27.0 ± 4.3 vs. 33.6 ± 2.3, p = 0.008) who received TKA [15]. With an alpha = 0.05, power = 0.80 and the same sampling ratio, the projected sample size needed is approximately nine opioid users and 25 non-users. Thus, the proposed number of patients of our study was adequate for the main objective.
2.3. Statistical analysis For statistical analysis, we compared demographic characteristics to ensure that we had selected matched cohorts. We performed unpaired two-tailed Student's t-test for continuous variables (Age, BMI, length of stay (LOS), range of motion (ROM)), and Pearson's Chi-Square test for categorical variables (Sex, Disposition, Charnley Class). We also compared clinical results to evaluate for an effect between opioid and non-opioid groups. For each patient-reported outcome measure (PROM), a generalized linear model was built to compare the main effects of changed PROM between preoperative opioid users and non-users. The model was adjusted for preoperative pain score to avoid potential confounding by the indication for opioid use and preoperative PROM and used the preoperative use of opioids as independent variables. PROMs including EQ5D index, VAS general health, and UCLA activity scores were collected. Statistical analysis was performed using the Statistical Package for the Social Sciences (SPSS) (version 19.0, SPSS Inc./IBM, Chicago, IL). Two-tailed values of p b 0.05 were considered statistically significant. Please cite this article as: Manalo JPM, et al, Preoperative opioid medication use negatively affect health related quality of life after total knee arthroplasty, Knee (2018), https://doi.org/10.1016/j.knee.2018.07.001
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3. Results 3.1. Demographic characteristics Patients who underwent TKA at our institution with at least one EQ-5D index score, EQ VAS general health scores, and UCLA activity scores were initially screened for inclusion in this study. Of this group, 30 patients were identified as having used opioids pre-operatively. The non-opioid cohort of 137 patients who had not used opioids prior to surgery was carefully selected to match the opioid cohort. Due to incomplete survey data at both preoperative and postoperative visits, only 55 patients from the nonuser group and 12 patients from the user group with complete data were retained for analysis. There was no difference between the preoperative opioid group and the non-opioid group in terms of BMI, Sex, or Charnley Class. The preoperative opioid group was significantly younger than the non-opioid group with the mean age at index surgery being 60.0 vs. 66.9 years, respectively (p = 0.003, Table 1). In regard to ROM, there was no difference between the pre-operative ROM in the groups with the nonopioid group having a mean ROM of 110.1° vs. 109.8° in the opioid group (p = 0.94). Moreover, there was no difference in postoperative ROM (p = 0.73) or change in ROM (p = 0.83) with each group on average increasing their ROM by at least 15°. Lastly, there was no difference in regard to length of stay (p = 0.35) or disposition (p = 0.96) between the two groups (Table 2). 3.2. Clinical outcome measures Prior to surgery, the pre-operative opioid group had a statistically significant lower UCLA PROM than the non-opioid group (1.1 ± 0.78, p = 0.005) (Table 3). The UCLA scores improved for both the preoperative opioid (1.17 ± 0.63, p b 0.001) and non-opioid cohorts (0.53 ± 0.47, p b 0.001). The non-opioid group had significantly higher pre-operative EQ VAS scores compared to the opioid group before the TKA surgery (5.0 ± 4.9, p = 0.043), and after the TKA surgery (6.6 ± 4.67, p = 0.007). Though there was a significant improvement of the EQ VAS scores in the non-opioid group after TKA (3.89 ± 6.70, p b 0.001), the opioid group did not show significant improvement in the EQ VAS scores (2.33 ± 12.7, p = 0.54). 4. Discussion Prescription opioid abuse and dependence is a major public health crisis. Initiatives to curb the opioid epidemic have focused on decreasing opioid prescriptions and treatment for abuse. It is important to understand the effects of preoperative opioid use on HRQoL after TKA especially with the increasing percentage of patients being treated with opioids prior to surgery [4, 5]. In this study we characterized the effect of preoperative opioid use on PROMs after TKA. Our results showed that TKA patients with preoperative opioid use showed significantly lower VAS scores and trends of lower UCLA and EQ-5D scores postoperatively compared to non-opioid patients. Specifically for total joint arthroplasty, it was found that narcotics and diabetic medications were the two most significant preoperative medication classes in lengthening inpatient stays, complications, and readmission rates [19, 20]. Another study showed continued opioid use after a 90 day period following TKA resulted in a higher adjusted risk for revision [21]. Recently, Dwyer et al. outlined the existing predilection for patients who undergo TKA and total hip arthroplasty (THA) to require increased and extended usage of narcotics and its correlation with mental health conditions [22]. Using data collected from medical records, our study showed that patients with preoperative opioid use showed significant worse postoperative VAS scores (p = 0.007) and trends of lower UCLA (p = 0.14) and EQ-5D (p = 0.12) scores, compared to patients not using opioid. We also found that TKA patient not using preoperative opioid showed significant improvement in all UCLA, EQ-5D and VAS scores, but patients with preoperative opioid use did not show significant improvement in their postoperative EQ-5D scores or in VAS scores. The lack of statistical significant difference may be attributed to the relatively small sample size of the preoperative opioid user group with complete pre-operative and postoperative data. A larger sample size is therefore warranted for future studies. In terms of amount of improvement, in neither group, the improvement of PROMs exceeded the minimal clinically important differences established by an earlier study for patients treated for femoroacetabular impingement (VAS N 15; EQ-5D N 0.16) [18]. However, our results showed a mean difference of EQ-5D score of 0.05, which is approximately 30% of the minimal clinically important differences as reported in [18] and is consistent with the findings of Smith et al. [15], who reported a mean difference of WOMAC of 6.6 (30% of the reported minimal clinically important difference).
Table 1 Demographic comparison between groups. Variable
Age (years) BMI (kg/m2) Sex Charnley Class ASA Class Preoperative ROM (°)
Non-users
Pre-opioid users
N
Mean
135 134 137 137 136 133
66.9 9.2 30.8 5.8 N (Male) = 57 N (Female) = 80 N (A) = 42; N (B) = 44; N (C) = 51 N (2) = 103 N (3) = 33 110.1 17.4
Standard deviation
Stats
N
Mean
30 30 30 30 30 29
60.0 9.6 32.9 7.3 N (Male) = 16 N (Female) = 14 N (A) = 6; N (B) = 11; N (C) = 13 N (2) = 19 N (3) = 11 109.8 21.5
Standard deviation
p value 0.003 0.092 0.24 0.50 0.16 0.94
Please cite this article as: Manalo JPM, et al, Preoperative opioid medication use negatively affect health related quality of life after total knee arthroplasty, Knee (2018), https://doi.org/10.1016/j.knee.2018.07.001
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Table 2 Length of stay and disposition between groups. Variable
Non-users
LOS DISPO Postoperative ROM (°) Change in ROM (°)
Pre-opioid users
Stats
N
Mean
Std. deviation
N
Mean
Std. deviation
p value
135 137 135 29
2.7 N (Home) = 101 126.8 15.7
1.1 N (Rehab) = 36 13.7 26.2
30 30 30 131
2.9 N (Home) = 22 125.9 16.8
1.4 N (Rehab) = 8 11.6 22.7
0.35 0.97 0.73 0.83
To our knowledge, no study has used the EQ-5D to investigate the effects of preoperative opioids prior to TKA. The EQ-5D is a multidimensional, non-disease specific tool that has previously been validated. It is a preference-based tool that measures utility and allows comparison of the cost-effectiveness of interventions. Being disease non-specific allows the EQ-5D to accommodate for case complexities and patient comorbidities. This tool allows us to measure not only the value of the intervention but also the effect of patient comorbidities on the intervention [23–25]. Our data suggests that opioid use prior to surgery is associated with inferior health related quality of life after total knee arthroplasty. These results are consistent with a previous study published by Nguyen et al. Their results showed that patients who weaned off opioids prior to surgery had similar WOMAC, short form 12 (SF12) health survey, and UCLA activity scores to patients who did not use opioids [9]. Weaning opioids prior to surgery is beneficial prior to TKA [26–28]. Smith et al. performed a systematic review of 17 studies comparing non-steroidal anti-inflammatory drugs with opioid pain medications for the treatments of knee osteoarthritis. They found no difference in effectiveness between the drug classes [27]. Weak opioids such as tramadol should be the last resort of non-operative treatment as recommended by the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) [29]. The data suggests that patients with knee arthritis who plan on receiving a total knee arthroplasty would benefit from avoiding opioid pain medication and maximize other treatment modalities such as non-steroidal anti-inflammatory drugs (NSAIDs), steroid injections, activity modification, weight loss, and radiofrequency ablation. In fact, in one study an association was found between preoperative narcotic use within three months of surgery causing a six fold increase in the rate of chronic opioid use [30]. This study should be interpreted in light of its potential limitations. Firstly, patients who were only on opioids for a short period of time may have different outcomes than a patient who has been on opioid pain medication for years. In order to address these limitations, during the data collection, we carefully reviewed the comprehensive patient history for each patient. Prospective studies controlling for the length and type of opioid consumption are needed to overcome these constraints. Secondly, the power analysis was conducted based on the study by Smith et al. who used the WOMAC score as the primary outcome assessment [15]. This is partially due to the lack of previous report on the EQ-5D score in the opioid user population and that WOMAC and EQ-5D scores share some common items such as daily activity and pain. It terms of the mean difference in PROMs between opioid user and non-users, our results showed a mean difference of EQ-5D score of 0.05, which is approximately 30% of the minimal clinically important differences as reported in [18] and is consistent with the findings of Smith et al. [15], who reported a mean difference of WOMAC of 6.6 (30% of the reported minimal clinically important difference). Additionally, significant difference was observed in the VAS score between opioid and non-opioid patients. However, a small sample size especially in the opioid user group remains a limitation of our study, which
Table 3 Comparison between preoperative and postoperative scores. Variable
N of pts
Mean UCLA Non-opioid Preop opioid Difference p — between groupsc VAS Non-opioid Preop opioid Difference p — between groups EQ5d-US Non-opioid Preop opioid Difference p — between groups a b c
Postoperativea
Difference
Std. deviation
Mean
Mean
Preoperative
Std. deviation
p — within groupb Std. deviation
1.0 1.0 0.64
0.53 1.17 0.64 b0.001
0.47 0.63 0.32
b0.001 b0.001
77.9 71.3 6.6 0.007
6.7 10.0 4.67
3.89 2.33 1.56 0.69
6.7 12.7 5.11
b0.001 0.54
0.79 0.74 0.05 0.12
0.07 0.19 0.06
0.12 0.09 0.03 0.67
0.05 0.23 0.07
b0.001 0.19
55 12
5.1 4.0 1.1 0.005
1.2 1.3 0.78
5.7 5.2 0.5 0.14
55 12
74.0 69.0 5.0 0.043
6.7 11.1 4.9
55 12
0.67 0.64 0.03 0.24
0.08 0.08 0.05
Adjusted for preoperative outcome scores. Paired t-test. Independent sample t test.
Please cite this article as: Manalo JPM, et al, Preoperative opioid medication use negatively affect health related quality of life after total knee arthroplasty, Knee (2018), https://doi.org/10.1016/j.knee.2018.07.001
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may also explain the non-significant improvement in EQ-5D and VAS scores within the opioid user group. Future studies with larger sample sizes are needed to further evaluate our findings. Thirdly, the EQ-5D is a non-specific tool and may not capture the full detail of the disease being investigated, however, it is recommended as the tool for economic evaluation of health care by the National Institute of Clinical Excellence [16, 31]. Fourthly, there was a significant difference in the postoperative follow-up time between groups, with the user group followed up at a longer time point after TKA surgery. However, the follow-up times were relatively long-term compared to previous short-term studies, allowing sufficient time for recovery. Opioid users exhibited trends of lower PROMs after TKA surgery than non-users. Lastly, there was a relatively small sample size in our study due to lack of complete data from either preoperative or postoperative survey. Despite this, the sample size of each group meets a power analysis to support the minimum power to detect a clinically significant difference between user and non-user groups. Future studies with large sample sizes are needed. In conclusion, TKA patients with preoperative opioid use had significantly lower VAS scores and trends of lower UCLA and EQ-5D scores postoperatively compared to non-opioid patients, suggesting the use of opioid medications prior to TKA negatively affects patient reported outcomes following surgery. The current findings provide useful clinical information that can be used in counseling patients to avoid opioids prior to undergoing total knee arthroplasty. Ethical statement The manuscript does not report the results of an experimental investigation on human subjects. This study was approved by the Institutional Committee or Review Board. Declarations of interest None. Funding None. Acknowledgments None. References [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] [19] [20] [21] [22] [23]
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Please cite this article as: Manalo JPM, et al, Preoperative opioid medication use negatively affect health related quality of life after total knee arthroplasty, Knee (2018), https://doi.org/10.1016/j.knee.2018.07.001
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Please cite this article as: Manalo JPM, et al, Preoperative opioid medication use negatively affect health related quality of life after total knee arthroplasty, Knee (2018), https://doi.org/10.1016/j.knee.2018.07.001
Contents lists available at ScienceDirect
The Knee
Preoperative opioid medication use negatively affect health related quality of life after total knee arthroplasty John Paul M. Manalo, Tiffany Castillo, David Hennessy, Yun Peng, Brian Schurko, Young-Min Kwon ⁎ Department of Orthopaedic Surgery, Massachusetts General Hospital, Harvard Medical School, USA
a r t i c l e
i n f o
Article history: Received 10 April 2018 Received in revised form 9 June 2018 Accepted 2 July 2018 Available online xxxx Keywords: Health related quality of life Total knee arthroplasty Patient reported outcomes Preoperative opioid
a b s t r a c t Background: Opioids are commonly prescribed to treat patients suffering from painful knee arthritis. However, the opioid epidemic in the United States constitutes a major public health concern. This study aims to characterize the effect of preoperative opioid use on patientreported outcome measures (PROMs) after total knee arthroplasty (TKA). Methods: PROMs collected from patients undergoing TKA were reviewed. We identified two matched cohorts: (1) 30 patients who used opioids preoperatively and (2) 137 patients who did not use opioids preoperatively. The non-opioid cohort was carefully selected to match the opioid cohort. Statistical analyses were performed to determine the difference in demographics, PROMs, length of stay, disposition and co-morbidities between the two cohorts. Results: The non-opioid users had significant improvement in both EuroQol5D (EQ-5D) PROMs and visual analogy scale (VAS) scores postoperatively (p b 0.001); however, preoperative opioid users did not show improvement in either measure. University of California Los Angles (UCLA) scores were significantly improved for both non-opioid users (p b 0.001) and opioid users (p b 0.001). Non-opioid users had higher preoperative EQ-5D scores than opioid users (p = 0.02). There was no difference in range of motion, length of stay, or disposition between cohorts. Conclusion: Our results demonstrated that TKA patients with preoperative opioid use had significantly lower VAS scores and trends of lower UCLA and EQ-5D scores postoperatively compared to non-opioid patients, suggesting the use of opioid medications prior to TKA negatively affects patient reported outcomes following surgery. The current findings provide useful clinical information that can be used in counseling patients prior to undergoing TKA. © 2018 Elsevier B.V. All rights reserved.
1. Introduction Knee arthritis is a significant cause of pain and decreased mobility, which can contribute to a poor quality of life. Treatment modalities for knee arthritis include physical therapy, anti-inflammatory drugs, walking aids, knee braces, opioid pain medications, and surgical intervention. Prescription opioids have long been used for the treatment of knee arthritis and the number of patients taking opiates who present to orthopedic surgeons for knee replacement continues to increase. Prescription opioid abuse is a major public health crisis. In 2013, there were an estimated 1.9 million individuals who were dependent or abused opioid pain medication [1]. Furthermore, from 1999 to 2015, the Centers for Disease Control and Prevention (CDC) estimated that there were over 183,000 deaths in the United States related to prescription opioid use in 2014 [2, 3]. Bedard et al. reported on
⁎ Corresponding author at: Department of Orthopaedic Surgery, Massachusetts General Hospital, Harvard Medical School, 55 Fruit St, Yawkey Suite 3B, Boston, MA 02114, USA. E-mail address: [email protected]. (Y.-M. Kwon).
https://doi.org/10.1016/j.knee.2018.07.001 0968-0160/© 2018 Elsevier B.V. All rights reserved.
Please cite this article as: Manalo JPM, et al, Preoperative opioid medication use negatively affect health related quality of life after total knee arthroplasty, Knee (2018), https://doi.org/10.1016/j.knee.2018.07.001
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patients using opioid pain medication within three months prior to total knee arthroplasty (TKA) during an eight-year period. Nearly one-third of their cohort used preoperative opioids and the percentage increased nine percent during the study period [4]. Wright et al. showed nearly 40% of patients with knee osteoarthritis received at least one opioid prescription in 2009. This percentage increased from 31% in 2003 [5]. Previous studies have shown worse outcomes in joint arthroplasty in patients who used opioids preoperatively. These studies have shown increased in-hospital complications, increased length of stay, prolonged narcotic use, and increased postoperative opioid consumption after total joint arthroplasty in patients who preoperatively used opioid pain medication [6–14]. However, there is a paucity of data regarding patient reported outcomes after total knee arthroplasty in patients who use opioid pain medication prior to surgery. Recently, Smith et al. showed preoperative opioid users had less pain relief using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score and the Pain Catastrophizing Scale [15]. To our knowledge, no study has compared the health-related quality of life (HRQoL) changes following TKA between opioid naïve patients and patients who use opioids preoperatively using the EuroQol5D (EQ-5D). The EQ-5D is a validated non-disease specific, preference-based, standardized instrument used to measure general health outcomes [16]. The purpose of this study was to compare the EQ-5D HRQoL measures after total knee arthroplasty in patients who used preoperative opioids vs. those who were opioid naïve.
2. Methods 2.1. Patients Institutional review board (IRB) approval was obtained for a retrospective review of patients in our hospital medical registry who underwent TKA with completed EQ-5D index scores, visual analog scale (EQ VAS) general health scores, and University of California Los Angles (UCLA) activity scores. The charts of these patients were reviewed and cohorts were separated based on preoperative opioid use. To obtain information regarding opioid use, we reviewed the electronic medical record of each qualifying patient. The presence or absence of opioid medications documented in preoperative clinic visit notes, the primary care provider notes or medication lists was used to classify the patients. We identified two cohorts of patients: (1) 137 patients who did not use opioids preoperatively and (2) 30 patients who used opioids prior to TKA. The non-opioid cohort was carefully selected to match the opioid cohort utilizing selection criteria which were decided upon before data collection. During chart review, one of the study authors carefully selected matched control patients for each opioid patient, with age difference less than 10 years, same sex and body mass index (BMI) difference less than five kilograms per square meter. More than one matched control subject for the same opioid user was allowed. Patient outcomes were collected preoperatively at 184 [496] days (median, [interquartile range]) and 166 [531] days for users and non-users, respectively (p = 0.67), and postoperatively at 519 [222] days and 352 [251] days for users and non-users respectively (p = 0.042).
2.2. Power analysis Prior to data collection, a statistical power analysis was performed for sample size estimation. Due to the lack of reports of the EQ-5D scores in the opioid user population, we relied on the study by Smith et al. [15], who compared another outcome variable WOMAC score at six-month follow-up between 36 preoperative opioid users and 120 non-users (mean ± standard deviation) (27.0 ± 4.3 vs. 33.6 ± 2.3, p = 0.008) with TKA. The effect size of this study was 1.91 (Cohen's d) and considered large according to Cohen's criteria [17]. Using their data, with an alpha = 0.05, power = 0.80 and the same sampling ratio, the projected sample size needed is approximately nine opioid users and 25 non-users. As a reference, the minimal clinically important difference is 0.16 for the EQ-5D score and 22 for the WOMAC score [18]. A statistical power analysis was performed for sample size estimation, based on published data from a similar study by Smith et al. that compared the changed WOMAC score from preoperative to six-month follow-up between 36 preoperative opioid users and 120 non-users (27.0 ± 4.3 vs. 33.6 ± 2.3, p = 0.008) who received TKA [15]. With an alpha = 0.05, power = 0.80 and the same sampling ratio, the projected sample size needed is approximately nine opioid users and 25 non-users. Thus, the proposed number of patients of our study was adequate for the main objective.
2.3. Statistical analysis For statistical analysis, we compared demographic characteristics to ensure that we had selected matched cohorts. We performed unpaired two-tailed Student's t-test for continuous variables (Age, BMI, length of stay (LOS), range of motion (ROM)), and Pearson's Chi-Square test for categorical variables (Sex, Disposition, Charnley Class). We also compared clinical results to evaluate for an effect between opioid and non-opioid groups. For each patient-reported outcome measure (PROM), a generalized linear model was built to compare the main effects of changed PROM between preoperative opioid users and non-users. The model was adjusted for preoperative pain score to avoid potential confounding by the indication for opioid use and preoperative PROM and used the preoperative use of opioids as independent variables. PROMs including EQ5D index, VAS general health, and UCLA activity scores were collected. Statistical analysis was performed using the Statistical Package for the Social Sciences (SPSS) (version 19.0, SPSS Inc./IBM, Chicago, IL). Two-tailed values of p b 0.05 were considered statistically significant. Please cite this article as: Manalo JPM, et al, Preoperative opioid medication use negatively affect health related quality of life after total knee arthroplasty, Knee (2018), https://doi.org/10.1016/j.knee.2018.07.001
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3. Results 3.1. Demographic characteristics Patients who underwent TKA at our institution with at least one EQ-5D index score, EQ VAS general health scores, and UCLA activity scores were initially screened for inclusion in this study. Of this group, 30 patients were identified as having used opioids pre-operatively. The non-opioid cohort of 137 patients who had not used opioids prior to surgery was carefully selected to match the opioid cohort. Due to incomplete survey data at both preoperative and postoperative visits, only 55 patients from the nonuser group and 12 patients from the user group with complete data were retained for analysis. There was no difference between the preoperative opioid group and the non-opioid group in terms of BMI, Sex, or Charnley Class. The preoperative opioid group was significantly younger than the non-opioid group with the mean age at index surgery being 60.0 vs. 66.9 years, respectively (p = 0.003, Table 1). In regard to ROM, there was no difference between the pre-operative ROM in the groups with the nonopioid group having a mean ROM of 110.1° vs. 109.8° in the opioid group (p = 0.94). Moreover, there was no difference in postoperative ROM (p = 0.73) or change in ROM (p = 0.83) with each group on average increasing their ROM by at least 15°. Lastly, there was no difference in regard to length of stay (p = 0.35) or disposition (p = 0.96) between the two groups (Table 2). 3.2. Clinical outcome measures Prior to surgery, the pre-operative opioid group had a statistically significant lower UCLA PROM than the non-opioid group (1.1 ± 0.78, p = 0.005) (Table 3). The UCLA scores improved for both the preoperative opioid (1.17 ± 0.63, p b 0.001) and non-opioid cohorts (0.53 ± 0.47, p b 0.001). The non-opioid group had significantly higher pre-operative EQ VAS scores compared to the opioid group before the TKA surgery (5.0 ± 4.9, p = 0.043), and after the TKA surgery (6.6 ± 4.67, p = 0.007). Though there was a significant improvement of the EQ VAS scores in the non-opioid group after TKA (3.89 ± 6.70, p b 0.001), the opioid group did not show significant improvement in the EQ VAS scores (2.33 ± 12.7, p = 0.54). 4. Discussion Prescription opioid abuse and dependence is a major public health crisis. Initiatives to curb the opioid epidemic have focused on decreasing opioid prescriptions and treatment for abuse. It is important to understand the effects of preoperative opioid use on HRQoL after TKA especially with the increasing percentage of patients being treated with opioids prior to surgery [4, 5]. In this study we characterized the effect of preoperative opioid use on PROMs after TKA. Our results showed that TKA patients with preoperative opioid use showed significantly lower VAS scores and trends of lower UCLA and EQ-5D scores postoperatively compared to non-opioid patients. Specifically for total joint arthroplasty, it was found that narcotics and diabetic medications were the two most significant preoperative medication classes in lengthening inpatient stays, complications, and readmission rates [19, 20]. Another study showed continued opioid use after a 90 day period following TKA resulted in a higher adjusted risk for revision [21]. Recently, Dwyer et al. outlined the existing predilection for patients who undergo TKA and total hip arthroplasty (THA) to require increased and extended usage of narcotics and its correlation with mental health conditions [22]. Using data collected from medical records, our study showed that patients with preoperative opioid use showed significant worse postoperative VAS scores (p = 0.007) and trends of lower UCLA (p = 0.14) and EQ-5D (p = 0.12) scores, compared to patients not using opioid. We also found that TKA patient not using preoperative opioid showed significant improvement in all UCLA, EQ-5D and VAS scores, but patients with preoperative opioid use did not show significant improvement in their postoperative EQ-5D scores or in VAS scores. The lack of statistical significant difference may be attributed to the relatively small sample size of the preoperative opioid user group with complete pre-operative and postoperative data. A larger sample size is therefore warranted for future studies. In terms of amount of improvement, in neither group, the improvement of PROMs exceeded the minimal clinically important differences established by an earlier study for patients treated for femoroacetabular impingement (VAS N 15; EQ-5D N 0.16) [18]. However, our results showed a mean difference of EQ-5D score of 0.05, which is approximately 30% of the minimal clinically important differences as reported in [18] and is consistent with the findings of Smith et al. [15], who reported a mean difference of WOMAC of 6.6 (30% of the reported minimal clinically important difference).
Table 1 Demographic comparison between groups. Variable
Age (years) BMI (kg/m2) Sex Charnley Class ASA Class Preoperative ROM (°)
Non-users
Pre-opioid users
N
Mean
135 134 137 137 136 133
66.9 9.2 30.8 5.8 N (Male) = 57 N (Female) = 80 N (A) = 42; N (B) = 44; N (C) = 51 N (2) = 103 N (3) = 33 110.1 17.4
Standard deviation
Stats
N
Mean
30 30 30 30 30 29
60.0 9.6 32.9 7.3 N (Male) = 16 N (Female) = 14 N (A) = 6; N (B) = 11; N (C) = 13 N (2) = 19 N (3) = 11 109.8 21.5
Standard deviation
p value 0.003 0.092 0.24 0.50 0.16 0.94
Please cite this article as: Manalo JPM, et al, Preoperative opioid medication use negatively affect health related quality of life after total knee arthroplasty, Knee (2018), https://doi.org/10.1016/j.knee.2018.07.001
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Table 2 Length of stay and disposition between groups. Variable
Non-users
LOS DISPO Postoperative ROM (°) Change in ROM (°)
Pre-opioid users
Stats
N
Mean
Std. deviation
N
Mean
Std. deviation
p value
135 137 135 29
2.7 N (Home) = 101 126.8 15.7
1.1 N (Rehab) = 36 13.7 26.2
30 30 30 131
2.9 N (Home) = 22 125.9 16.8
1.4 N (Rehab) = 8 11.6 22.7
0.35 0.97 0.73 0.83
To our knowledge, no study has used the EQ-5D to investigate the effects of preoperative opioids prior to TKA. The EQ-5D is a multidimensional, non-disease specific tool that has previously been validated. It is a preference-based tool that measures utility and allows comparison of the cost-effectiveness of interventions. Being disease non-specific allows the EQ-5D to accommodate for case complexities and patient comorbidities. This tool allows us to measure not only the value of the intervention but also the effect of patient comorbidities on the intervention [23–25]. Our data suggests that opioid use prior to surgery is associated with inferior health related quality of life after total knee arthroplasty. These results are consistent with a previous study published by Nguyen et al. Their results showed that patients who weaned off opioids prior to surgery had similar WOMAC, short form 12 (SF12) health survey, and UCLA activity scores to patients who did not use opioids [9]. Weaning opioids prior to surgery is beneficial prior to TKA [26–28]. Smith et al. performed a systematic review of 17 studies comparing non-steroidal anti-inflammatory drugs with opioid pain medications for the treatments of knee osteoarthritis. They found no difference in effectiveness between the drug classes [27]. Weak opioids such as tramadol should be the last resort of non-operative treatment as recommended by the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) [29]. The data suggests that patients with knee arthritis who plan on receiving a total knee arthroplasty would benefit from avoiding opioid pain medication and maximize other treatment modalities such as non-steroidal anti-inflammatory drugs (NSAIDs), steroid injections, activity modification, weight loss, and radiofrequency ablation. In fact, in one study an association was found between preoperative narcotic use within three months of surgery causing a six fold increase in the rate of chronic opioid use [30]. This study should be interpreted in light of its potential limitations. Firstly, patients who were only on opioids for a short period of time may have different outcomes than a patient who has been on opioid pain medication for years. In order to address these limitations, during the data collection, we carefully reviewed the comprehensive patient history for each patient. Prospective studies controlling for the length and type of opioid consumption are needed to overcome these constraints. Secondly, the power analysis was conducted based on the study by Smith et al. who used the WOMAC score as the primary outcome assessment [15]. This is partially due to the lack of previous report on the EQ-5D score in the opioid user population and that WOMAC and EQ-5D scores share some common items such as daily activity and pain. It terms of the mean difference in PROMs between opioid user and non-users, our results showed a mean difference of EQ-5D score of 0.05, which is approximately 30% of the minimal clinically important differences as reported in [18] and is consistent with the findings of Smith et al. [15], who reported a mean difference of WOMAC of 6.6 (30% of the reported minimal clinically important difference). Additionally, significant difference was observed in the VAS score between opioid and non-opioid patients. However, a small sample size especially in the opioid user group remains a limitation of our study, which
Table 3 Comparison between preoperative and postoperative scores. Variable
N of pts
Mean UCLA Non-opioid Preop opioid Difference p — between groupsc VAS Non-opioid Preop opioid Difference p — between groups EQ5d-US Non-opioid Preop opioid Difference p — between groups a b c
Postoperativea
Difference
Std. deviation
Mean
Mean
Preoperative
Std. deviation
p — within groupb Std. deviation
1.0 1.0 0.64
0.53 1.17 0.64 b0.001
0.47 0.63 0.32
b0.001 b0.001
77.9 71.3 6.6 0.007
6.7 10.0 4.67
3.89 2.33 1.56 0.69
6.7 12.7 5.11
b0.001 0.54
0.79 0.74 0.05 0.12
0.07 0.19 0.06
0.12 0.09 0.03 0.67
0.05 0.23 0.07
b0.001 0.19
55 12
5.1 4.0 1.1 0.005
1.2 1.3 0.78
5.7 5.2 0.5 0.14
55 12
74.0 69.0 5.0 0.043
6.7 11.1 4.9
55 12
0.67 0.64 0.03 0.24
0.08 0.08 0.05
Adjusted for preoperative outcome scores. Paired t-test. Independent sample t test.
Please cite this article as: Manalo JPM, et al, Preoperative opioid medication use negatively affect health related quality of life after total knee arthroplasty, Knee (2018), https://doi.org/10.1016/j.knee.2018.07.001
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may also explain the non-significant improvement in EQ-5D and VAS scores within the opioid user group. Future studies with larger sample sizes are needed to further evaluate our findings. Thirdly, the EQ-5D is a non-specific tool and may not capture the full detail of the disease being investigated, however, it is recommended as the tool for economic evaluation of health care by the National Institute of Clinical Excellence [16, 31]. Fourthly, there was a significant difference in the postoperative follow-up time between groups, with the user group followed up at a longer time point after TKA surgery. However, the follow-up times were relatively long-term compared to previous short-term studies, allowing sufficient time for recovery. Opioid users exhibited trends of lower PROMs after TKA surgery than non-users. Lastly, there was a relatively small sample size in our study due to lack of complete data from either preoperative or postoperative survey. Despite this, the sample size of each group meets a power analysis to support the minimum power to detect a clinically significant difference between user and non-user groups. Future studies with large sample sizes are needed. In conclusion, TKA patients with preoperative opioid use had significantly lower VAS scores and trends of lower UCLA and EQ-5D scores postoperatively compared to non-opioid patients, suggesting the use of opioid medications prior to TKA negatively affects patient reported outcomes following surgery. The current findings provide useful clinical information that can be used in counseling patients to avoid opioids prior to undergoing total knee arthroplasty. Ethical statement The manuscript does not report the results of an experimental investigation on human subjects. This study was approved by the Institutional Committee or Review Board. Declarations of interest None. Funding None. Acknowledgments None. References [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] [19] [20] [21] [22] [23]
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Please cite this article as: Manalo JPM, et al, Preoperative opioid medication use negatively affect health related quality of life after total knee arthroplasty, Knee (2018), https://doi.org/10.1016/j.knee.2018.07.001