Abstract
Background
This study aimed to determine if smokers at the time of arthroscopic rotator cuff repair met the minimally clinical important difference and substantial clinical benefit for Patient-Reported Outcomes Measurement Information System Upper Extremity, Depression, and Pain Interference scores in comparison to nonsmoking patients in a retrospective review.
Methods
Clinical outcomes and Patient-Reported Outcomes Measurement Information System scores were compared between a cohort of nonsmokers and current or former smokers (smokers). Further sub-analysis compared a cohort of nonsmokers propensity-matched 1:1 to a cohort of current/former smokers via age, body mass index, and tear size.
Results
A total of 182 patients, 80 smokers and 102 nonsmokers, were included. Smokers had statistically different-sized tears with more rated massive (P = 0.02) and more reoperations (P = 0.02). Smokers met substantial clinical benefit thresholds at a lower rate than nonsmokers for Patient-Reported Outcomes Measurement Information System Upper Extremity (P = 0.03). In the sub-analysis, 74 smokers were matched to 74 nonsmokers. Smokers had a lower change in Patient-Reported Outcomes Measurement Information System Upper Extremity (P = 0.007) and Patient-Reported Outcomes Measurement Information System Pain Interference (P = 0.03) postoperatively. Fewer smokers met minimally clinical important difference for Patient-Reported Outcomes Measurement Information System Upper Extremity postoperatively (P = 0.003) and more had reoperations (P = 0.02).
Discussion
Overall, smokers demonstrated smaller improvements in function, and pain, and were less likely to meet minimally clinical important differences and substantial clinical benefits for Patient-Reported Outcomes Measurement Information System Upper Extremity at 6 months follow-up when compared to nonsmokers after rotator cuff repair.
Keywords: Patient-Reported Outcomes Measurement Information System, minimally clinical important difference, arthroscopic rotator cuff repair
Introduction
Smoking tobacco products can have devastating consequences on surgical outcomes such as delayed wound healing1–3 and increased overall complication rate following orthopedic surgery.4–6 Pre-surgical counseling on smoking cessation is recommended for all patients prior to orthopedic surgeries to minimize the risks of complications, which include elevated infection rates, delayed union on fracture, and impaired overall bone healing.5–9 While arthroscopic rotator cuff repair is the gold standard for rotator cuff tears after failure of conservative treatment, 10 smoking has previously shown a direct positive correlation with increased severity of pre-operative rotator cuff tears.11–13 Increased rates of overall retear and reoperation following RCR 13 and higher rates of healing failure, defined as a discontinuity in the repaired tendons when evaluated by magnetic resonance imaging (MRI)/ultrasound after 6 months, 11 have also been observed. Additionally, smoking represents an independent predictor of increased complications, readmission, and sepsis within 30 days following arthroscopic rotator cuff repair (RCR) 14 ; however, the long-term effects of smoking on patient-recorded postoperative outcomes are not well understood.
Established by the NIH, the Patient-Reported Outcome Measurement Information System (PROMIS) provides a reliable, and reproducible assessment tool to evaluate how patients perceive their own outcomes after RCRs. 15 Using PROMIS computerized adaptive test (CAT), patient perceptions of their own upper extremity physical function (Upper Extremity), the degree to which pain impacts their quality of life (Pain Interference), and their mental health status (Depression) can be systematically evaluated. The significance of changes in these scores can be further compared between pre-operative and postoperative time points via the minimal clinically important difference (MCID) and substantial clinical benefit (SCB) metrics. The MCID offers a validated means to assess whether improvements following RCR were sufficient to improve a patient's perceived quality of life versus those that only produce a statistical difference void of perceptible improvement. Likewise, the SCB is defined as the threshold outcome for postoperative improvement that is perceived by the patient as being considerable. Both the MCID and SCB have been validated to assess changes in PROMIS Upper Extremity (PROMIS-UE), PROMIS Pain Interference (PROMIS-PI),16,17 and PROMIS Depression (PROMIS-D) 18 following arthroscopic RCR.
While prior studies13,14 have shown the negative effects of smoking on RCR, to our knowledge, few studies compare the proportion of patients meeting MCID after RCR between patients with no smoking history and current or former smokers for PROMIS CAT scores. The purpose of this study was to assess whether a cohort of former or current smokers at the time of surgery met the MCID for PROMIS-UE, -D, and -PI scores in comparison to nonsmokers following RCR. We hypothesized that the smoker cohort would have worse postoperative outcomes compared to the nonsmoker cohort.
Methods
A retrospective review of a prospectively collected database of patients undergoing arthroscopic rotator cuff repair between July 2017 and July 2020 was performed. Included patients were > 18 years of age who underwent arthroscopic RCR by three fellowship-trained orthopedic surgeons at a single hospital system. Patients were identified by Common Procedural Terminology (CPT) code 29827. The final analysis included patients with a rotator cuff tendon tear, identified on preoperative imaging, who completed at least one preoperative and one 6-month postoperative PROMIS (-UE, -PI, and -D) CAT scores. Exclusion criteria were defined by age < 18 years, previous ipsilateral shoulder surgery, or open or mini-open RCR (Figure 1).
Figure 1.
Differences in Patient Reported Outcome Measurement Information System (PROMIS) scores at 6 months.
Patients completed three PROMIS CAT score forms (-UE, -PI, and -D) at preoperative and postoperative office visits on a tablet computer. Patient data was collected and stored in the Research Electronic Data Capture (REDCap) platform, a secure, web-based application system. PROMIS CAT score results were collected at preoperative, 6-week postoperative, 3-month postoperative, 6-month postoperative, and final follow-up after 6 months. The PROMIS CAT algorithm produces standardized T-scores based on normative US population data with a mean score of 50 and a standard deviation of 10. Increased PROMIS-UE score demonstrates increased upper extremity function, whereas increased PROMIS-PI indicates increased pain interfering with daily activities and increased PROMIS-D represents a higher level of depression. Studies have recognized PROMIS CAT scores as an effective tool for measuring function and pain in patients following RCR.16–20 MCID, as well as SCB values for PROMIS-UE, PROMIS-PI, and PROMIS-D, were obtained from a previous study by Tramer et al. 18 specifically calculating these values in a rotator cuff repair population using an anchor-based methodology.
Patient demographics and injury characteristics were collected from each patient's electronic medical record. Demographic data included sex, age, race/ethnicity, body mass index (BMI), zip code, and smoking status. Smoking pack years were collected for current and former smokers. Injury characteristics were collected from preoperative MRI reports to differentiate partial and full-thickness tears and the number of involved tendons. MRI images were interpreted by board-certified musculoskeletal radiologists and the performing orthopedic surgeon. Rotator cuff size was categorized using the DeOrio and Cofield classification system: small (< 1 cm), medium (1–2.9 cm), large (3–4.9 cm), and massive (≥ 5 cm). 21 Reoperations were reviewed until the last clinical follow-up. Retears were not assessed routinely, and imaging was only performed if clinically indicated.
Table 1.
Demographics.
| Nonsmoker | Current/former smoker | P value | |
|---|---|---|---|
| N | 102 | 80 | |
| Age in years (mean ± SD) | 58.2 ± 8.7 | 58.9 ± 8.5 | 0.61 |
| Sex | 0.74 | ||
| Male (N) | 45.1% (46) | 47.5% (38) | |
| Female (N) | 54.9% (56) | 52.5% (42) | |
| Race | 0.02* | ||
| American Indian/Alaska Native | 0 | 1 | |
| Black/African American | 28 | 19 | |
| White/Caucasian | 65 | 56 | |
| Asian | 8 | 0 | |
| Unknown | 0 | 2 | |
| Other | 1 | 2 | |
| BMI (mean ± SD) | 31.5 ± 6.2 | 30.7 ± 6.1 | 0.57 |
| Preoperative scores (mean ± SD) | |||
| PROMIS-UE | 29.9 ± 6.6 | 29.5 ± 5.3 | 0.93 |
| PROMIS-PI | 61.9 ± 5.1 | 63.4 ± 4.7 | 0.06 |
| PROMIS-D | 46.6 ± 9.7 | 47.9 ± 8.5 | 0.28 |
| Original tear size | 0.19 | ||
| Partial | 8 | 11 | |
| Full | 94 | 69 | |
| Number of tendon tears | 0.60 | ||
| 1 | 51 | 46 | |
| 2 | 41 | 27 | |
| 3 | 10 | 7 | |
| Tear size | 0.02* | ||
| Small | 11 | 11 | |
| Medium | 75 | 42 | |
| Large | 12 | 10 | |
| Massive | 3 | 11 |
BMI: body mass index; D: depression; MCID: minimal clinically important difference; N: number; PI: pain interference; PROMIS: Patient-Reported Outcomes Measurement Information System; SD: standard deviation; UE: upper extremity.
* P value < 0.05.
Patients were identified as currently smoking, former smokers, nonsmokers, or unknown in the electronic medical record. A cohort of patients documented as current or former smokers were included in the “smoker” cohort. These patients were compared to a cohort of nonsmokers in terms of demographic information, clinical outcomes, and PROMIS scores. A sub-analysis was also performed where a cohort of nonsmokers were propensity matched 1:1 to a cohort of smokers via age, BMI, and tear size. Matching was performed via multivariate logistic regression of age, tear size, and BMI as independent variables against retear as the dependent variable. The probability of retear determined from the logit function was then used to perform matching.
Table 2.
Patient-reported and clinical outcomes at 6 months.
| Nonsmoking | Current/former smoker | P value | |
|---|---|---|---|
| N | 102 | 80 | |
| PROMIS-UE difference (mean ± SD) | 10.4 ± 9.9 | 8.1 ± 9.7 | 0.07 |
| PROMIS-PI difference | −10.6 ± 9.5 | −8.9 ± 8.5 | 0.23 |
| PROMIS-D difference | −4.1 ± 9.6 | −4.3 ± 8.1 | 0.60 |
| Proportion meeting MCID PROMIS-UE | 67.7% (67/99) | 58.2% (46/79) | 0.19 |
| Proportion meeting MCID PROMIS-PI | 36.3% (37/102) | 35.0% (28/80) | 0.86 |
| Proportion meeting MCID PROMIS-D | 34.0% (34/100) | 38.8% (31/80) | 0.51 |
| Proportion meeting SCB PROMIS-UE | |||
| Proportion meeting SCB PROMIS-PI | 54.6% (54/99) | 38.0% (30/79) | 0.03* |
| Proportion meeting SCB | 33.3% (34/102) | 27.5% (22/80) | 0.40 |
| PROMIS-D | 34.0% (34/100) | 38.8% (31/80) | 0.51 |
| Retear percentage (N) | 11.7% (12/102) | 18.8% (15/80) | 0.19 |
| Reoperation percentage (N) | 5.9% (6/102) | 16.3% (13/80) | 0.02* |
D: depression; MCID: minimal clinically important difference; N: number; PI: pain interference; PROMIS: Patient-Reported Outcomes Measurement Information System; SCB: substantial clinical benefit; SD: standard deviation; UE: Upper Extremity.
* P value < 0.05.
Statistical analysis
We conducted standard descriptive statistical analyses, including the calculation of mean, median, standard deviation (SD), and interquartile range (IQR). To assess the normality of continuous variables, the Shapiro-Wilk test was employed. Continuous variables displaying a normal distribution were presented as mean ± SD, while those with a non-normal distribution were expressed as median [IQR]. We employed the paired t-test to compare differences in continuous variables for normal distributions and the Mann-Whitney U-test for non-normal distributions. Categorical data differences were assessed using either the χ2 test or the Fisher exact test, as appropriate. Statistical significance was defined as a P value < 0.05. All statistical analyses were conducted using JMP® (Version 16.2.0, SAS Institute Inc., Cary, NC, 1989-2022). This study received approval from the institutional review board at our institution (Protocol ID: 13787).
Results
A total of 182 patients were included with 80 patients identified as current or former smokers compared to 102 nonsmokers. The mean age of patients in the smoker cohort was 58.9 ± 8.5 years and 58.2 ± 8.7 years for nonsmokers (P = 0.61) (Table 1). In the smoker cohort, 47.5% (38 patients) were male whereas 45.1% (46 patients) of nonsmokers were male (P = 0.74). No significant difference in BMI was observed between smokers and nonsmokers (30.7 ± 6.1 vs. 31.5 ± 6.2; P = 0.57). Amongst smokers, 86.3% (69 patients) presented with full-thickness tears versus 92.2% (94 patients) of nonsmokers (P = 0.19), and 13.8% (11 patients) of smokers presented with massive tears versus 2.9% (three patients) of nonsmokers (P = 0.02). Retear rate was 18.8% (15 patients) among smokers and 11.7% (12 patients) among nonsmokers (P = 0.19). The reoperation rate was 16.3% (13 patients) in the current/former smoking cohort in contrast to 5.9% (six patients) in the nonsmoking group (P = 0.02). Reasons for reoperation included rotator cuff retear, incomplete healing, hardware removal, and adhesive capsulitis. The last follow-up for smokers was at a mean of 12.6 ± 12.9 months and a mean of 11.2 ± 11.5 months for nonsmokers (P = 0.44).
No significant differences were found between smokers and nonsmokers PROMIS-UE (8.1 ± 9.7 vs. 10.4 ± 9.9; P = 0.07), PROMIS-PI (−8.9 ± 8.5 vs. −10.6 ± 9.5; P = 0.23), and PROMIS-D (−4.3 ± 8.1 vs. −4.1 ± 9.6; P = 0.60) scores at 6 months postoperatively (Table 2) (Figure 1). No significant differences in achieving MCID at 6 months postoperatively were found for PROMIS-UE (58.2% vs. 67.7%; P = 0.19), PROMIS-PI (35.0% vs. 36.3%; P = 0.86), or PROMIS-D (38.8% vs. 34.0%; P = 0.51), respectively (Figure 2). Smokers had a smaller proportion of patients meeting SCB for PROMIS-UE compared to nonsmokers (38.0% vs. 54.6%; P = 0.03). No significant differences were found in proportion meeting SCB for PROMIS-PI (27.5% vs. 33.3%; P = 0.40) or PROMIS-D (38.8% vs. 34.0%; P = 0.51) (Figure 2).
Figure 2.
The proportion of matched cohort patients meeting minimal clinically important difference (MCID) at 6 months.
In the sub-analysis, 74 patients in the smoking cohort were propensity-matched to 74 nonsmokers (Table 3). There was a significant difference in PROMIS-UE (8.6 ± 9.8 vs. 12.3 ± 10.0; P = 0.007) and PROMIS-PI (−9.1 ± 8.5 vs. −12.8 ± 10.1; P = 0.03) improvement at 6 months when comparing smokers to nonsmokers, respectively. No significant difference was found when comparing PROMIS-D at 6 months (−4.6 ± 8.2 vs. −5.0 ± 9.3; P = 0.62) (Table 4). Patients in the smoking cohort had a significantly lower percentage of patients meeting MCID for PROMIS-UE at 6 months (60.3% vs. 82.4%; P = 0.003) compared to nonsmokers. No significant differences were found in achieving MCID postoperatively at 6 months for PROMIS-PI (36.5% vs. 41.9%; P = 0.50) and PROMIS-D (40.5% vs. 32.4%; P = 0.30). A smaller proportion of smokers met SCB for PROMIS-UE compared to matched nonsmokers (39.7% vs. 68.9%; P < 0.001) at 6 months. At the final follow-up, no significant difference in retear rate was found between smokers and nonsmokers (18.9% vs. 9.5%; P = 0.15). The reoperation rate was significantly higher at the last follow-up (16.2% vs. 4.1%; P = 0.02) when comparing smokers to nonsmokers.
Table 3.
Matched cohort demographics by smoking status.
| Nonsmoking | Current/former smoker | P value | |
|---|---|---|---|
| N | 74 | 74 | |
| Age (mean ± SD) | 56.9 ± 8.6 | 58.9 ± 8.6 | 0.25 |
| Sex | 0.25 | ||
| Male percentage (n) | 56.8% (42) | 47.3% (35) | |
| Female percentage (n) | 43.2% (32) | 52.7% (39) | |
| Race | 0.23 | ||
| American Indian/Alaska Native | 0 | 1 | |
| Black/African American | 27 | 18 | |
| White/Caucasian | 45 | 51 | |
| Asian | 1 | 0 | |
| Unknown | 0 | 2 | |
| Other | 1 | 2 | |
| BMI (mean ± SD) | 30.6 ± 5.2 | 30.5 ± 5.7 | 0.88 |
| Preoperative scores (mean ± SD) | |||
| PROMIS-UE | 30.0 ± 6.1 | 29.4 ± 5.0 | 0.84 |
| PROMIS-PI | 61.8 ± 4.8 | 63.2 ± 4.4 | 0.06 |
| PROMIS-D | 46.3 ± 9.9 | 48.1 ± 8.1 | 0.08 |
| Tear size | 0.88 | ||
| Small | 8 | 11 | |
| Medium | 43 | 42 | |
| Large | 12 | 10 | |
| Massive | 11 | 11 |
BMI: body mass index; D: depression; MCID: minimal clinically important difference; N: number; PI: pain interference; PROMIS: Patient-Reported Outcomes Measurement Information System; SD: standard deviation; UE: upper extremity.
* P value < 0.05.
Discussion
This study found that patients who were smokers and former smokers before RCR had less improvement in their postoperative PROMIS-UE and PROMIS-PI scores compared to matched nonsmokers. Smokers were also less likely than their matched counterparts to meet the MCID and SCB for PROMIS-UE following RCR both before and after controlling for age, BMI, and tear size. In addition, we found an increased risk of reoperation after RCR amongst smokers compared to nonsmokers.
We found smokers had worse improvement in function compared to nonsmokers after RCR. Studies have found mixed results regarding the impact of smoking on postoperative RCR outcomes. Kukkonen et al. 22 compared 114 smokers with 450 nonsmokers and found that smoking was linked to significantly lower postoperative Constant shoulder outcome scores at 1 year after RCR. Park et al. 11 propensity-matched smokers to nonsmokers after RCR with similar tear sizes and found higher healing failure rates (29.4% vs. 5.9%, P = 0.023), despite no discernable differences in functional outcomes at 6 months postoperative follow-up. In a subsequent systematic review and meta-analysis, Fan et al. 13 reviewed 14 articles comprising 73,817 patients (8553 smokers and 65,264 nonsmokers) and found no significant differences in the functional outcomes of smokers versus nonsmokers for American Shoulder and Elbow Surgeons score (ASES), Simple Shoulder Test score, University of California–Los Angeles score, or visual analog scale (VAS) score. Our study applied the higher threshold of MCID and SCB achievement as opposed to only statistical differences in outcome scores to better extrapolate clinical relevance to our results. Smoking has been shown to be a risk factor in achieving MCID and SCB as reported by Tramer et al. 18 While the exact mechanism of smoking on short-term rotator cuff function outcomes is unclear, smoking has been previously linked with lower functional scores in preoperative RCR patients, 23 which may make a postoperative gain of function more difficult for these patients. Additionally, this difference may result from the impact of smoking on normal tendon healing, thus diminishing postoperative function. Nicotine exposure has been shown to reduce vascularity at the site of tendon healing leading to worse biomechanical tendon properties, such as increased laxity and reduced cross-sectional area in rats with induced Achilles tendon tears. 24 Longer-term follow-up is needed to determine if smoking patients can continue to improve to the level of nonsmokers postoperatively.
Table 4.
Matched cohort 6-month outcomes stratified by smoking status.
| Nonsmoking | Current/former smoker | P value | |
|---|---|---|---|
| N | 74 | 74 | |
| Propensity scores | 0.46 ± 0.15 | 0.46 ± 0.15 | 0.94 |
| PROMIS-UE difference | 12.3 ± 10.0 | 8.6 ± 9.8 | 0.007* |
| PROMIS-PI difference | −12.8 ± 10.1 | −9.1 ± 8.5 | 0.03* |
| PROMIS-D difference | −5.0 ± 9.3 | −4.6 ± 8.2 | 0.62 |
| Proportion meeting MCID PROMIS-UE | 82.4% (61) | 60.3% (44) | 0.003* |
| Proportion meeting MCID PROMIS-PI | 41.9% (31) | 36.5% (27) | 0.50 |
| Proportion meeting MCID PROMIS-D | 32.4% (24) | 40.5% (30) | 0.30 |
| Proportion meeting SCB PROMIS-UE | |||
| Proportion meeting SCB PROMIS-PI | 68.9% (51/74) | 39.7% (29/73) | < 0.001* |
| Proportion meeting SCB | 37.8% (28/74) | 28.4% (21/74) | 0.22 |
| PROMIS-D | 32.4% (24/74) | 40.5% (30/74) | 0.31 |
| Retear percentage | 9.5% (7) | 18.9% (14) | 0.15 |
| Reoperation percentage | 4.1% (3) | 16.2% (12) | 0.02* |
D: depression; MCID: minimal clinically important difference; N: number; PI: pain interference; PROMIS: Patient-Reported Outcomes Measurement Information System; SCB: substantial clinical benefit; SD: standard deviation; UE: upper extremity.
Data are depicted as mean ± standard deviation or percentage (n) as appropriate.
* P value < 0.05.
Smokers in our study were more likely to require further operations after RCR compared to nonsmokers. Recent studies have shown an association between smoking and increased reoperation rate following RCR, consistent with our findings.13,25 In a review of 41,467 patients, smoking was found to be the greatest modifiable risk factor associated with failed primary RCR requiring revision repair at any point postoperatively. 25 One commonly supported theory for this association posits that smoking produces more substantial initial tendon injury. Smoking has a positive relationship with preoperative rotator cuff tendon tear size 12 and larger preoperative tear sizes have been linked to decreased postoperative tendon healing26,27 and higher rates of postoperative retear13,28 and reoperation. 13 In our study we interestingly did not find a difference in retear rate between smokers and non-smokers, yet we only evaluated symptomatic patients for retear as opposed to every patient. Consequently, it is possible that there would have been a higher rate of retear between our cohorts had we evaluated asymptomatic tears using advanced imaging. Of note, our retear data, while not significant, did show an overall larger proportion of retears amongst smokers. We also controlled for tear size, the most consistently demonstrated risk factor for poor postoperative healing following RCR, 27 in our matching analysis and still found more reoperations amongst smokers. Therefore, it is likely that the proposed mechanistic differences in tendon health and healing resulting from smoking,11–13,24,29,30 rather than tear size alone, are substantial contributors to our observed differences in reoperation rates between smokers and nonsmokers.
Limitations
This study was not without limitations. While we clinically had follow-up past 6 months, we did not have uniform longer-term PROMIS score completion to review for all patients, therefore we are not able to comment on the progression of these patients’ PROMIS scores after 6 months. There is a possibility smokers progress to similar outcomes as the control cohort at one year or later follow-up. We also did not uniformly assess patients postoperatively for retears therefore our retear rate consists of clinical retears only and it is possible there was a higher number of asymptomatic retears. Although propensity matching controlled for many factors known to influence RCR outcomes, it was not possible to control for all factors, such as smoking-related health conditions, which may contribute to worse outcomes in our smoking cohort. Another limitation is there may be differences in other demographic or clinical outcomes that would only have become detectable with a more significant sample size. In our matched cohort analysis, a larger sample size may have revealed a statistically significant difference in retear rates between smokers and nonsmokers.
Conclusion
Patients who smoke currently or had a history of smoking preoperatively demonstrated smaller improvements in function, pain scores, and were less likely to meet MCID and SCB for PROMIS-UE when compared to nonsmokers after arthroscopic rotator cuff repair. Smokers were also more likely to undergo reoperations when compared to a matched control cohort.
Footnotes
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding: The author(s) received no financial support for the research, authorship, and/or publication of this article.
ORCID iDs: Michael A Gaudiani https://orcid.org/0000-0002-3366-1708
Johnny K Kasto https://orcid.org/0009-0000-0339-0428
Stephanie J Muh https://orcid.org/0000-0001-6617-4116
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