Are psychosocial variables, sleep characteristics or central pain processing prognostic factors for outcome following rotator cuff repair? A protocol for a prospective longitudinal cohort study.

INTRODUCTION: Prognosis following surgical rotator cuff repair (RCR) is often established through the assessment of non-modifiable biomedical factors such as tear size. This understates the complex nature of recovery following RCR. There is a need to identify modifiable psychosocial and sleep-related variables, and to find out whether changes in central pain processing influence prognosis after RCR. This will improve our knowledge on how to optimise recovery, using a holistic rehabilitation approach. METHODS AND ANALYSIS: This longitudinal study will analyse 141 participants undergoing usual care for first time RCR. Data will be collected 1-21 days preoperatively (T1), then 11-14 weeks (T2) and 12-14 months (T3) postoperatively. We will use mixed-effects linear regression to assess relationships between potential prognostic factors and our primary and secondary outcome measures-the Western Ontario Rotator Cuff Index; the Constant-Murley Score; the Subjective Shoulder Value; Maximal Pain (Numeric Rating Scale); and Quality of Life (European Quality of Life, 5 dimensions, 5 levels). Potential prognostic factors include: four psychosocial variables; pain catastrophising, perceived stress, injury perceptions and patients' expectations for RCR; sleep; and four factors related to central pain processing (central sensitisation inventory, temporal summation, cold hyperalgesia and pressure pain threshold). Intercorrelations will be assessed to determine the strength of relationships between all potential prognostic indicators.Our aim is to explore whether modifiable psychosocial factors, sleep-related variables and altered central pain processing are associated with outcomes pre-RCR and post-RCR and to identify them as potential prognostic factors. ETHICS AND DISSEMINATION: The results of the study will be disseminated at conferences such as the European Pain Congress. One or more manuscripts will be published in a peer-reviewed SCI-ranked journal. Findings will be reported in accordance with the STROBE statement and PROGRESS framework. Ethical approval is granted by the Ethical commission of Canton of Zurich, Switzerland, No: ID_2018-02089 TRIAL REGISTRATION NUMBER: NCT04946149.

Which Risk Factors Are Associated with Pain and Patient-reported Function in Patients with a Rotator Cuff Tear?

BACKGROUND: Patient-reported measures guide physicians in clinical decision making and therefore it is critical to determine what clinical factors are associated with these scores. Psychological and physical factors are commonly studied separately in patients with rotator cuff tears to determine their influence on outcomes. It is well established that psychological distress and scapular motion change in the presence of a symptomatic rotator cuff tear. However, these factors have not been studied simultaneously in a clinical setting to determine their association with shoulder outcome scores. QUESTION/PURPOSE: After controlling for relevant confounding variables, what physical and psychological factors are associated with better (1) American Shoulder and Elbow Surgeons (ASES) scores for function, (2) ASES pain scores, and (3) total ASES scores? METHODS: Fifty-nine patients with a potential symptomatic rotator cuff tear were recruited and agreed to participate in this cross-sectional study. Of those, 85% (50 of 59) met eligibility criteria for a primary diagnosis of an MRI-confirmed symptomatic partial-thickness or full-thickness rotator cuff tear without a history of shoulder surgery. Demographics, rotator cuff tear size, arm flexion, and clinical scapular motion during active arm flexion were evaluated by experienced examiners using standardized procedures. Patients completed the ASES questionnaire and the Optimal Screening for Prediction of Referral and Outcomes-Yellow Flag assessment form, which measures 11 different pain-related psychological distress symptoms. Three separate stepwise multiple linear regression analyses were performed for ASES pain, function, and total scores, with significance set at p < 0.05. RESULTS: This model found that ASES function scores were associated with four factors: older age, increased arm flexion, increased percentage of scapular external rotation during arm flexion, and increased scores for acceptance of chronic pain (adjusted r2 = 0.67; p = 0.01). Those four factors appear to explain 67% of the observed variance in ASES function scores in patients with rotator cuff tears. Furthermore, increased percentage of scapular external rotation during arm flexion and decreased fear-avoidance beliefs related to physical activity scores (adjusted r2 = 0.36; p < 0.01) were associated with better ASES pain scores. And finally, better ASES total scores were associated with four factors: increased arm flexion, increased percentage of scapular upward rotation, increased scapular external rotation during arm flexion, and decreased fear-avoidance beliefs related to physical activity scores (adjusted r2 = 0.65; p < 0.001). CONCLUSION: Our results favor adopting a comprehensive biopsychological clinical assessment for patients with rotator cuff tears that specifically includes humeral and scapular motion, fear-avoidance behaviors, and pain coping behaviors along with demographics. These particular physical and psychological variables were found to be associated with the ASES and, therefore, should be clinically examined simultaneously and targeted as part of a tailored treatment plan. LEVEL OF EVIDENCE: Level II, prognostic study.

How does rerupture affect sleep and quality of life in patients undergoing arthroscopic rotator cuff repair?

Background/aim: Sleep disturbance and related improvement in quality of life as a result of arthroscopic repair in rotator cuff tear (RCT) patients can be considered as an important parameter. The aim of our study is to evaluate the rotator cuff by ultrasonography (USG) in the first postoperative year and to examine whether there is a difference between sleep disturbance and quality of life between cases of rupture and healthy patients. In addition, we aim to compare the preoperative and at least the first postoperative year's sleep disturbances and quality of life among patients who underwent arthroscopic RCT repair and to examine the effects of factors affecting this situation. Materials and methods: We retrospectively reviewed the records of patients who were operated on for RCT. In this process, 257 patients were examined and 76 patients who met the inclusion criteria were included in the study. The Pittsburgh sleep quality index (PSQI), Constant­Murley shoulder score (CSS), and Oxford shoulder score (OSS) were used to evaluate the results preoperatively and at the last control visit of each patient. In the USG performed in the postoperative first year, the rotor cuff was evaluated in terms of rerupture. Results: It was observed that 14 (18.4%) patients' rotor cuffs were reruptured and those of 62 (81.6%) patients were intact. The preoperative PSQI, CSS, and OSS values of the patients were calculated as an average of 10.79 ± 3.58, 35.61 ± 8.88, and 17.61 ± 4.20 and the mean postoperative values were calculated as 5.45 ± 1.68, 81.55 ± 5.27, and 38.05 ± 3.06, respectively. The postoperative PSQI value was statistically significantly lower in patients with tears of <1 cm (PSQI: 4.29 ± 0.73) than in those with tears of 1­3 cm (PSQI: 5.50 ± 2.17) and 3­5 cm (PSQI: 5.88 ± 1.25) (P < 0.001). The mean CSS and OSS values were significantly higher in postoperative measurements for all tear types. According to the size of the tear, postoperative CSS and OSS values were statistically significantly lower in patients with tears of 3­5 cm (CSS: 78.59 ± 4.50 and OSS: 36.18 ± 2.47) than those with <1 cm (CSS: 85.43 ± 2.14 and OSS: 40.57 ± 1.55) and 1­3 cm (CSS: 83.21 ± 5.35 and OSS: 39.07 ± 2.94) tears (P < 0.001). Conclusion: In the USG performed in the postoperative first year, it was determined that the patients with healthy rotator cuffs recovered better than those with rerupture.

Effects of Anxiety and Depression Measured via the Hospital Anxiety and Depression Scale on Early Pain and Range of Motion After Rotator Cuff Repair.

BACKGROUND: Preoperative anxiety and depression are independent predictors of clinical outcomes after arthroscopic rotator cuff repair. However, few studies have evaluated correlations between outcomes such as pain and range of motion (ROM) after arthroscopic rotator cuff repair and preoperative anxiety and depression. PURPOSE: To evaluate the effects of preoperative anxiety and depression, measured using the Hospital Anxiety and Depression Scale (HADS), on early pain and ROM after rotator cuff repair. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: A total of 144 consecutive patients who underwent arthroscopic rotator cuff repair were enrolled and divided into 2 groups according to HADS scores: group A, those with a healthy psychological status (n = 103; anxiety ≤7 and depression ≤7), and group B, those with psychological distress (n = 41; anxiety ≥8 or depression ≥8). Clinical outcomes were assessed using the visual analog scale for pain (pVAS) and ROM at 3 and 6 months postoperatively and annually. RESULTS: There were no significant preoperative differences in age, sex, tear size, pVAS scores, and ROM. However, at 3 months postoperatively, group A showed significantly lower mean pVAS scores (2.2 ± 1.3 vs 3.4 ± 1.8, respectively; P = .001) and significantly higher mean forward flexion (146.4°± 23.0° vs 124.1°± 28.2°, respectively; P < .001) than group B, as well as significantly higher mean levels of internal rotation at the back (T11.5 ± 2.8 vs L1.9 ± 2.5, respectively; P < .001) and significantly higher mean external rotation (42.4°± 15.9° vs 35.2°± 16.8°, respectively; P = .019). At 6 months postoperatively, the mean pVAS score was still significantly lower in group A than in group B (0.8 ± 1.6 vs 1.8 ± 2.1, respectively; P = .016), but other ROM measurements had no significant differences. There was also no significant difference in clinical and functional outcomes at the final follow-up. CONCLUSION: Anxiety and depression negatively affected clinical outcomes after rotator cuff repair. Recovery from pain and of ROM after arthroscopic rotator cuff repair occurred more quickly in patients with a healthy psychological status. Therefore, assessments of preoperative psychological status should be emphasized to improve early clinical outcomes after arthroscopic rotator cuff repair.

Rehabilitation following rotator cuff repair: A nested qualitative study exploring the perceptions and experiences of participants in a randomised controlled trial.

OBJECTIVE: To investigate acceptability, barriers to adherence with the interventions, and which outcome measures best reflect the participants' rehabilitation goals in a pilot and feasibility randomised controlled trial evaluating early patient-directed rehabilitation and standard rehabilitation, including sling immobilisation for four weeks, following surgical repair of the rotator cuff of the shoulder. DESIGN: Nested qualitative study. SETTING: Five English National Health Service Hospitals. SUBJECTS: Nineteen patient participants who had undergone surgical repair of the rotator cuff and 10 healthcare practitioners involved in the trial. METHOD: Individual semi-structured interviews. Data were analysed thematically. RESULTS: Four themes: (1) Preconceptions of early mobilisation; many participants were motivated to enter the trial for the opportunity of removing their sling and getting moving early. (2) Sling use and movement restrictions; for some, sling use for four weeks was unacceptable and contributed to their pain, rather than relieving it. (3) Tensions associated with early mobilisation; clinical tensions regarding early mobilisation and the perceived risk to the surgical repair were apparent. (4) Processes of running the trial; participants found the trial processes to be largely appropriate and acceptable, but withholding the results of the post-operative research ultrasound scan was contentious. CONCLUSION: Trial processes were largely acceptable, except for withholding results of the ultrasound scan. For some participants, use of the shoulder sling for a prolonged period after surgery was a reported barrier to standard rehabilitation whereas the concept of early mobilisation contributed tension for some healthcare practitioners due to concern about the effect on the surgical repair.

Patients with depression and anxiety symptoms from adjustment disorder related to their shoulder may be ideal patients for arthroscopic rotator cuff repair.

BACKGROUND: Mood symptoms may be due to shoulder-related depression or anxiety or clinical anxiety/depression. The objective of this study was to evaluate the relationship of shoulder-related and pre-existing diagnosis of depression or anxiety with changes in American Shoulder and Elbow Surgeons (ASES) score after rotator cuff repair. METHODS: A retrospective review of prospectively collected data on subjects undergoing arthroscopic rotator cuff repair was reviewed. Preoperative and postoperative ASES, questions from the Western Ontario Rotator Cuff index questions directed to feelings of depression/anxiety related to the shoulder, and pre-existing diagnoses of depression and/or anxiety were recorded. The Wilcoxon rank sum test was used to compare changes, and Spearman's correlation was used to correlate changes in mood and ASES between male and female subjects and those with and without anxiety and/or depression. RESULTS: One hundred seventy-one subjects (53 female; mean age, 58.0 years; standard deviation [SD], 8.5) who underwent arthroscopic rotator cuff repair were evaluated with the mean follow-up of 36.6 months (SD, 17.5). Forty-six subjects (mean age, 58.8 years; SD, 8.2) had pre-existing diagnoses of depression and/or anxiety and 125 subjects (mean age, 57.7 years; SD, 8.7) did not. Patients showed improvement in Western Ontario Rotator Cuff shoulder-related depression (Δ 22.3) and anxiety (Δ 24.7). There was a strong correlation between the change in mood symptoms and the change in ASES score, for depression (r = 0.74) and anxiety (r = 0.71). Patients with and without clinical diagnosis of anxiety or depression experienced similar changes in mood symptoms related to the shoulder and ASES scores (P = .65, P = .39). Patients' ASES scores were less correlated with changes in shoulder-related mood symptoms; however, if patients had clinical depression/anxiety compared with those without (r = 0.68 vs. 0.75, P < .0001 for depression; r = 0.56 vs. r = 0.74, P < .0001 for anxiety). CONCLUSIONS: After rotator cuff repair, symptoms of depression/anxiety related to the shoulder improved dramatically with or without pre-existing clinical diagnosis of depression or anxiety. As the patient-reported functional outcomes of those with pre-existing clinical diagnosis of anxiety/depression improved, they did not experience as strong as an improvement in their mood symptoms as those without prior diagnoses and may benefit from directed treatment of these symptoms. Patients with shoulder-related mood symptoms only, conversely, experience a strong relationship between their improvement in function with their mood symptoms and may be ideal candidates for rotator cuff surgery. It is important for clinicians to separate mood symptoms related to adjustment disorder from the rotator cuff injury from clinical depression and anxiety.

Increased Health Care Costs and Opioid Use in Patients with Anxiety and Depression Undergoing Rotator Cuff Repair.

PURPOSE: To (1) quantify the prevalence of mood disorders in patients undergoing arthroscopic rotator cuff repair (RCR) by use of a large claims database and (2) compare opioid use and medical costs in the year before and the year after RCR between patients with and without comorbid mood disorders. METHODS: A large claims database was queried to identify patients who underwent arthroscopic RCR (Current Procedural Terminology code 29827) between October 2010 and December 2015. All patients were then screened for insurance claims relating to either anxiety or depression. We compared net costs and opioid use both 1 year preoperatively and 1 year postoperatively between patients with and without mood disorders by use of an analysis of covariance. RESULTS: A total of 170,329 patients (97,427 male patients [57.2%] and 72,902 female patients [42.8%]) undergoing arthroscopic RCR were identified. Of the 170,329 patients, 46,737 (27.4%) had comorbid anxiety or depression, and after adjustment for preoperative cost, sex, age, and both preoperative and postoperative opioid use, the 1-year postoperative cost was 7.05% higher for those with a preoperative mood disorder than for those without a mood disorder. In addition, opioid use both in the 180 days prior to surgery (36.7% vs 26.9%) and more than 90 days after surgery (33.0% vs 27.2%) was substantially greater in the group with comorbid depression or anxiety. CONCLUSIONS: In patients with comorbid mood disorders, opioid use and health care costs were increased both preoperatively and postoperatively. The increased cost in this patient population is estimated at $62.3 million annually. In an effort to provide high-quality, value-based care, treatment strategies should be developed to identify these patients preoperatively and provide the appropriate resources needed to improve the probability of a successful surgical outcome. LEVEL OF EVIDENCE: Level III, retrospective, comparative therapeutic study.

Sick leave and return to work after surgery for type II SLAP lesions of the shoulder: a secondary analysis of a randomised sham-controlled study.

OBJECTIVES: To compare days on sick leave and assess predictors of return to work following shoulder surgery. DESIGN: A secondary analysis of a randomised controlled trial. SETTING: Orthopaedic department. PARTICIPANTS: 114 patients with type II superior labral tear from anterior to posterior of the shoulder. INTERVENTIONS: Labral repair, biceps tenodesis or sham surgery. OUTCOME MEASURES: Sick leave was obtained from national registers for the last year before and 2 years following surgery. Total and shoulder related number of days on sick leave were obtained, using international diagnostic codes. We applied the difference-in-difference approach to compare the differences in the change in mean work days on sick leave between groups over time, backwards logistic regression and lasso regression to evaluate predictors. RESULTS: Mean total number of work days on sick leave during the 2 years after surgery was 148 (range 0-460) days. More than 80% of the sick leave days were taken by 22% of the patients. Days on sick leave classified as shoulder-related constituted 80% of the total. In all three treatment groups, the mean total number of days on sick leave doubled the year after surgery. Sham surgery and labral repair had fewer postoperative sickness absence days compared with biceps tenodesis but differences were not significant when adjusted for days of sick leave the year before surgery. Predictors of return to work at 2 years analysed by logistic regression were no sick leave (OR 8.0, 95% CI 2.4 to 26.0) and moderate symptoms of anxiety or depression (OR 0.16, 95% CI 0.05 to 0.5) at inclusion. Similar results were obtained by lasso regression but manual work was an additional predictor. CONCLUSIONS: Change in mean work days on sick leave comparing sham surgery, labral repair and biceps tenodesis, was not significantly different. Sick leave, symptoms of anxiety and depression, and manual work at inclusion predicted work status 2 years after surgery. TRIAL REGISTRATION NUMBER: NCT00586742.

Adaptation and transcultural translation of the Rotator Cuff Quality of Life questionnaire into Spanish.

BACKGROUND: The objective of this study was the transcultural adaptation of the Rotator Cuff Quality of Life questionnaire and the determination of the reliability and validity of the questionnaire in the Spanish population with rotator cuff disease. One of the translators was a physiotherapist, and the other was an English philologist. METHODS: The participants comprised 170 subjects with rotator cuff pathology. Test-retest reliability was established by the intraclass correlation coefficient. Internal consistency was established using the Cronbach α. Convergent validity was established by comparison with the Disabilities of the Arm, Shoulder and Hand questionnaire, Shoulder Pain and Disability Index, Spanish version of the Oxford Shoulder Score, and Spanish version of the Western Ontario Shoulder Instability index using the Spearman correlation coefficient. Estimation of the error in the measurements was calculated with the standard error of measurement. Assessment of reproducibility was performed with 30 minutes between the first and second administrations of the questionnaire. RESULTS: The Cronbach α was 0.99, showing high internal consistency. The intraclass correlation coefficient was 0.9 (95% confidence interval, 0.99-0.99; P < .001), indicating high test-retest reliability. The Spearman correlation coefficient showed a good relationship in all cases: Disabilities of the Arm, Shoulder and Hand, ρ = 0.9 (P < .001); Oxford Shoulder Score, ρ = 0.7 (P < .001); Shoulder Pain and Disability Index, ρ = 0.8 (P < .001); and Western Ontario Shoulder Instability index, ρ = 0.8 (P < .001). The standard error of measurement indicated little variability in the measurements (2.7%). CONCLUSIONS: The Spanish version of the Rotator Cuff Quality of Life questionnaire is a valid and reliable instrument for the subjective evaluation of patients with a diagnosis of rotator cuff pathology in the Spanish population.

Effect of affective temperament on outcome of rotator cuff surgery.

INTRODUCTION: Although numerous risk factors have been described, the effects of temperament, which is defined as a risk factor for certain disorders, on the outcome of patients undergoing rotator cuff surgery have not been investigated. HYPOTHESIS: We investigated whether a relationship exists between affective temperament and the outcome of patients undergoing rotator cuff surgery. MATERIAL AND METHODS: The outcomes of 176 patients undergoing rotator cuff surgery were examined using the Oxford and Constant questionnaires as well as visual analog scale values preoperatively and postoperatively. Inclusion criteria were defined as 1) dissatisfaction with pain despite 6 months of nonoperative treatment; 2) rotator cuff defects with full-thickness, small- to large-sized defects; 3) presence of a single dominant temperament or nondominant temperament; 4) no history of a diagnosed psychiatric disorder; and 5) a minimum of greater than 1 year of follow-up after surgery. Exclusion criteria were 1) other comorbid shoulder pathology; 2) irreparable or partial rotator cuff rupture; 3) grade 3 retractions; 4) grade 3-4 fatty infiltration; 5) other comorbid diseases such as diabetes, thyroid disorders, or inflammatory diseases; 6) history of shoulder surgery; 7) infection of the shoulder joint; 8) neurologic deficit in muscles around the shoulder; 9) two or more dominant temperaments; and 10) history of acromioclavicular joint resection and/or biceps tenodesis with cuff repair. All patient temperaments were evaluated according to the Temperament Evaluation of Memphis, Pisa, Paris and San Diego auto questionnaire version. RESULTS: The mean follow-up time was 45.5 months. The outcomes of patients with depressive temperament were worse than of patients with a nondominant temperament. This situation was observed both preoperatively and postoperatively. However, a similar relationship between nondominant and anxious temperament groups was observed only postoperatively. CONCLUSION: We noticed that depressive and anxious temperaments had a negative effect on patient outcomes after rotator cuff surgery; however, nondominant temperaments had a positive effect on patient outcomes. LEVEL OF EVIDENCE: Level III; Retrospective Comparative Study.

The Effect of Preexisting and Shoulder-Specific Depression and Anxiety on Patient-Reported Outcomes After Arthroscopic Rotator Cuff Repair.

BACKGROUND: Few studies have considered the potential effect of depression or anxiety on outcomes after rotator cuff repair. PURPOSE: To evaluate the effect of a preexisting diagnosis of depression or anxiety, as well as the feeling of depression and anxiety directly related to the shoulder, on the American Shoulder and Elbow Surgeons (ASES) score. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: This study is a retrospective review of prospectively collected data on patients who underwent arthroscopic rotator cuff repair and were evaluated by the ASES score preoperatively and at a minimum 12 months postoperatively as part of the senior author's shoulder registry. Preexisting diagnoses of depression and/or anxiety were recorded, and questions from the Western Ontario Rotator Cuff Index directed at feelings of depression or anxiety related to the shoulder were also evaluated. The Wilcoxon rank sum test was used to compare ASES scores between patients with and without anxiety and/or depression. Spearman correlation was used to correlate questions on depression and anxiety with ASES scores. RESULTS: A total of 187 patients (63 females, 124 males; mean age, 58.6 years, SD, 8.7 years) undergoing arthroscopic rotator cuff repair were evaluated with a mean follow-up of 47.5 months (SD, 17.4 months; range, 12-77 months). Fifty-three patients (mean age, 60 years; SD, 8.6 years) had preexisting diagnoses of depression and/or anxiety and 134 patients (mean age, 58.1 years; SD, 8.7 years) did not. Patients with depression and/or anxiety had significantly lower preoperative and postoperative ASES scores (60.7 vs 67.8, P = .014; and 74.6 vs 87.1, P = .008, respectively). The change in ASES scores from preoperative to postoperative, however, was not significantly different (18.0 vs 14.9). A higher score of depression or anxiety related to the shoulder had a negative correlation with the preoperative (r = -0.76, P < .0001; and r = -0.732, P < .0001, respectively) and postoperative (r = -0.31, P = .0001; and r = -0.31, P = .0003, respectively) ASES scores, but a positive correlation (r = 0.50, P < .0001; and r = 0.43, P < .0001, respectively) with the change in ASES scores. CONCLUSION: Patients with a history of depression and/or anxiety have lower outcome scores preoperatively and postoperatively; however, they should expect the same amount of relief from arthroscopic rotator cuff repair as those without a history of depression or anxiety. Stronger feelings of depression or anxiety directly related to the shoulder correlated with lower preoperative and postoperative outcome scores, but a greater amount of improvement from surgery. The results from this study suggest that a preexisting diagnosis of depression or anxiety, as well as feelings of depression or anxiety directly related to the shoulder, should be considered during the management of patients with rotator cuff tears.

Sleep Disturbance and Rotator Cuff Tears: A Systematic Review.

Background andObjectives: Sleep disorders are one of the most common complaints of patients with rotator cuff (RC) tears. However, potential correlations between the treatment of RC tears and the causal factors of sleep disorders are still under discussion. The aim of this review is to evaluate quality of sleep in patients before and after surgery for RC tears and to identify which factors affected patients' sleep. Materials and Methods: A systematic review was conducted. To provide high quality of the review, the included studies were evaluated with the standardized tool "Quality Assessment Tool for Quantitative Studies" developed by the Effective Public Health Practice Project. Results: The search strategy yielded 78 articles. After duplicate removal and titles, abstracts and full-texts review, four studies were included in the systematic review. Concerning shoulder function, the most frequently reported scale was the Simple Shoulder Test (SST). Regarding sleep quality, the most frequently reported score was the Pittsburgh Sleep Quality Index (PSQI). Conclusion: We found that the majority of patients with RC tears had a sleep disturbance, especially before surgery with a general improvement in sleep quality post-operatively. Moreover, sleep quality was correlated with pain and it also seems that factors as comorbidities, obligatory position during night time, preoperative and prolonged postoperative use of narcotics and psychiatric issues may play an important role in sleep quality.

Poor quality patient reported outcome measures bias effect estimates in orthopaedic randomized studies.

OBJECTIVES: The objective was to assess the potential for biased treatment effects associated with patient-reported outcome measures (PROMs) of varying psychometric quality in randomized clinical trials (RCTs) for rotator cuff disease (RCD). STUDY DESIGN AND SETTING: We searched for RCTs published in the past 5 years (January 2011 to December 2016) in the top five 2015 impact factor orthopedic journals. We accepted RCTs including human participants with RCD, published in English, and using PROMs specific to RCD. We extracted data on study design, sample size, risk of bias for RCTs, quality of PROM used, estimates of effect, and associated measures of variance. PROMs were given numerical ratings of psychometric quality from a prior publication. Continuous measures of effect were transformed by dividing the effect estimate by the standard deviation. Multilevel linear regression analyses were performed to determine whether PROM quality was associated with the magnitude of effect. RESULTS: Overall, we included 72 RCTs reporting 174 separate outcomes. Mean sample size was 66.8 (95% CI 62.30 to 71.27), mean risk of bias score across all studies was 7.00/10 (95% CI 6.72 to 7.29), psychometric quality summary scores ranged from -2 to 10, and the standardized mean effect estimate was 0.47 (95% CI -0.17 to 1.11). Regression revealed that higher-quality PROMs had smaller estimates of effect (ß = -0.32; 95% CI -0.51 to -0.13; P = 0.001). We also found that a longer follow-up period predicted slightly increased effect estimates (ß = 0.08; 95% CI 0.02 to 0.13; P = 0.007). CONCLUSIONS: PROMs with poor or unknown psychometric properties overestimate treatment effects in clinical research of RCD by 68.4% (ß -0.32/standardized mean effect 0.47). To our knowledge, this is the first empirical evidence that variations in the quality of PROMs bias treatment effect estimates. Researchers and clinicians using data from PROMs must be cautious to explore the quality of that measure so as to not mislead decision-making resulting from biased outcomes.

PROMIS CAT forms demonstrate responsiveness in patients following arthroscopic rotator cuff repair across numerous health domains.

BACKGROUND: Recent studies of patients with rotator cuff tears have demonstrated improved efficiency with Patient-Reported Outcomes Measurement Information System (PROMIS) when compared with traditional patient-reported outcome measures (PROM). However, these studies have been cross-sectional in nature and the responsiveness of PROMIS computer adaptive test (CAT) forms has not been evaluated. The purpose of this study was to determine the responsiveness of PROMIS CAT assessments in patients undergoing arthroscopic rotator cuff repair. METHODS: All patients undergoing arthroscopic rotator cuff repair by one of 3 fellowship-trained surgeons were included in the study. PROMIS CAT upper extremity physical function ("PROMIS-UE"), pain interference ("PROMIS-PI"), and depression ("PROMIS-D") scores from preoperative and 6-month postoperative visits were collected and analyzed. Patient-centric demographic factors, tear size, and biceps involvement were also correlated to preoperative and postoperative PROMIS scores. RESULTS: A total of 101 patients were enrolled in the study. The average age was 59.8 ± 8.9 years with 51 males (50.5%). Preoperative PROMIS-UE, PROMIS-PI, and PROMIS-D CAT scores improved significantly from 29.8 ± 6.0, 62.6 ± 5.1, and 48.4 ± 8.7, respectively, to 40.9 ± 9.8, 51.2 ± 9.3, and 42.9 ± 9.0, respectively, at 6-month follow-up (P < .001). Preoperative correlations were found between PROMIS-UE and PROMIS-PI scores (P < .001) and between PROMIS-PI and PROMIS-D scores (P = .001). No significant correlation was found between PROMIS-UE and PROMIS-D scores (P = .08), preoperatively. Preoperative PROMIS-UE, PROMIS-PI, or PROMIS-D scores were not correlated with rotator cuff tear size (P = .4). CONCLUSION: PROMIS CAT forms demonstrate responsiveness in patients undergoing arthroscopic rotator cuff repair across numerous domains.

Do we really allow patient decision-making in rotator cuff surgery? A prospective randomized study.

BACKGROUND: There is a growing patient interest in being involved in the decision-making process. However, little information is provided on how this information should be structured. Does it make a difference, in patient treatment decision-making, whether information is given based on the benefits or on the side effects in rotator cuff disorders? METHODS: It is a prospective randomized study that includes patients diagnosed with rotator cuff tears. Patients were randomly allocated to either group A (benefit-inform) or group B (side effect-inform) and were asked to answer the following questions based on their assigned group: Group A: Your doctor informs you that you have a rotator cuff tear and states that if he/she surgically repairs your cuff tear you will improve and that the cuff remains healed at the 2-year follow-up in 71% of the cases where surgery is done. Would you choose surgery? Yes or No Group B: Your doctor informs you that you have a rotator cuff tear and that if he/she surgically repairs your cuff tear you will improve and that the cuff is torn again at 2-year follow-up in 29% of the cases where surgery is done. Would you choose surgery? Yes or No Age, gender, the shoulder affected and the functional status assessed through the Constant score were also recorded. RESULTS: 80 patients were randomized (43 to group A and 37 to group B). The patients assigned to group A (benefit) accepted surgery significantly more frequently than those assigned to group B (complication) (P = 0.000). In group A, 36 of 43 (84%) accepted surgery, compared to 17 of 37 (46%) in group B. CONCLUSIONS: The way that information on rotator cuff disorders is provided strongly influences patients' treatment decisions. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03205852 . Registered 29 June 2017. Retrospectively registered.

Does having a rotator cuff repair prior to reverse total shoulder arthroplasty influence the outcome?

AIMS: The number of rotator cuff repairs that are undertaken is increasing. Reverse shoulder arthroplasty (RSA) is the procedure of choice for patients with rotator cuff arthropathy. We sought to determine whether patients who underwent rotator cuff repair and subsequent RSA had different outcomes compared with a matched control group who underwent RSA without a previous rotator cuff repair. PATIENTS AND METHODS: All patients with a history of rotator cuff repair who underwent RSA between 2000 and 2015 with a minimum follow-up of two years were eligible for inclusion as the study group. Outcomes, including the American Shoulder and Elbow Surgeons (ASES) scores, were compared with a matched control group of patients who underwent RSA without having previously undergone rotator cuff repair. RESULTS: The study group included 45 patients. Their mean age was 69 years (sd 8.6) and 27 patients (60%) were women. The mean ASES score improved from 43.1 to 76.6 two years postoperatively, and to 66.9 five years postoperatively. There was no significant difference between the outcomes at two years in the two groups (all p ≥ 0.05), although there was significantly more improvement in ASES scores in the control group (44.5 vs 33.4; p = 0.01). However, there was no significant difference between ASES scores at two and five years when baseline ASES scores were matched in the two groups (p = 0.42 at two years; p = 0.35 at five years). CONCLUSION: Significant improvements in ASES scores were seen following RSA in patients who had previously undergone rotator cuff repair. They had higher baseline ASES scores than those who had not previously undergone this surgery. However, there was no significant difference in outcomes between the two groups, two years postoperatively. Previous rotator cuff repair does not appear to affect the early outcome after RSA adversely.

Translation, cross-cultural adaptation and validation of the polish version of the Oxford Shoulder Score in patients undergoing arthroscopic rotator cuff repair.

BACKGROUND: The Oxford Shoulder Score (OSS) is a simple and reliable, joint-specific, self-reported outcome measure. It can be applied in patients with shoulder disease other than instability. The purpose of this study was to perform a translation, cultural adaptation of the Polish version of the OSS and to evaluate its selected psychometric properties in patients after arthroscopic rotator cuff repair. METHODS: Sixty-nine subjects participated in the study, with a mean age 55.5 (ranging from 40 to 65 years). The OSS has been translated using the widely accepted guidelines. All patients completed the Polish version of OSS (OSS-PL), the short version of the Disabilities of Arm, Shoulder and Hand Questionnaire (QuickDASH), the Short Form-36 v. 2.0 (SF-36) and the 7-point Global Rating of Change Scale (GRC). RESULTS: High internal consistency of 0.96 was found using Cronbach's alpha coefficient. Reliability of the OSS resulted in Intraclass Correlation Coefficient (ICC) = 0.99, Standard Error of Measurement (SEM) = 1.14 and Minimal Detectable Change (MDC) = 3.15. The validity analysis showed a moderate (General health r = 0.34) to high (Physical role functioning r = 0.82) correlation between the OSS-PL and SF-36 and a high correlation between the OSS-PL and the QuickDASH (r = - 0.92). CONCLUSIONS: The Polish version of OSS is a reliable and valid, self-reported questionnaire, which can be applied in patients with a rotator cuff tear undergoing reconstruction surgery. The very good psychometric properties of the Polish version of the OSS indicate that it can be used in clinical practice and scientific research.

Validation of the Polish version of the Western Ontario Rotator Cuff Index in patients following arthroscopic rotator cuff repair.

BACKGROUND: The Western Ontario Rotator Cuff Index (WORC) is a joint specific outcome tool that assesses the quality of life in patients with various rotator cuff problems. Our purpose was to evaluate selected psychometric characteristics (internal consistency, validity, reliability and agreement) of the Polish version of WORC in patients undergoing rotator cuff repair. METHODS: Sixty-nine subjects took part in the study with a mean age 55.5 (range 40-65). All had undergone arthroscopic rotator cuff repair in 2015-2016. Data from 57 patients in whom symptoms in the shoulder joint had not changed within 10-14 days were analyzed in a WORC test-retest using the Intraclass Correlation Coefficient (ICC), Standard Error of Measurement (SEM) and Minimal Detectable Change (MDC). WORC was compared to the short version of the Disabilities of Arm, Shoulder and Hand Questionnaire (QuickDash) and the Short Form-36 v. 2.0 (SF-36). RESULTS: High internal consistency of 0.94 was found using Cronbach's alpha coefficient. Reliability of the WORC resulted in ICC = 0.99, agreement assessed with SEM and MDC amounted to 1.62 and 4.48 respectively. The validity analysis of WORC showed strong correlations with QuickDash and SF-36 PCS (Physical Component Summary), while moderate with SF-36 MCS (Mental Component Summary). WORC had no floor or ceiling effect. CONCLUSIONS: The Polish version of the WORC is a reliable and valid tool with high internal consistency for assessing the quality of life in patients undergoing arthroscopic rotator cuff repair.

Are Psychologic Factors Associated With Shoulder Scores After Rotator Cuff Surgery?

BACKGROUND: Psychologic factors are associated with pain and disability in patients with chronic shoulder pain. Recent research regarding the association of affective psychologic factors (emotions) with patients' pain and disability outcome after surgery disagrees; and the relationship between cognitive psychologic factors (thoughts and beliefs) and outcome after surgery is unknown. QUESTIONS/PURPOSES: (1) Are there identifiable clusters (based on psychologic functioning measures) in patients undergoing shoulder surgery? (2) Is poorer psychologic functioning associated with worse outcome (American Shoulder and Elbow Surgeons [ASES] score) after shoulder surgery? METHODS: This prospective cohort study investigated patients undergoing shoulder surgery for rotator cuff-related shoulder pain or rotator cuff tear by one of six surgeons between January 2014 and July 2015. Inclusion criteria were patients undergoing surgery for rotator cuff repair with or without subacromial decompression and arthroscopic subacromial decompression only. Of 153 patients who were recruited and consented to participate in the study, 16 withdrew before data collection, leaving 137 who underwent surgery and were included in analyses. Of these, 124 (46 of 124 [37%] female; median age, 54 years [range, 21-79 years]) had a complete set of four psychologic measures before surgery: Depression, Anxiety and Stress Scale; Pain Catastrophizing Scale; Pain Self-Efficacy Questionnaire; and Tampa Scale for Kinesiophobia. The existence of clusters of people with different profiles of affective and cognitive factors was investigated using latent class analysis, which grouped people according to their pattern of scores on the four psychologic measures. Resultant clusters were profiled on potential confounding variables. The ASES score was measured before surgery and 3 and 12 months after surgery. Linear mixed models assessed the association between psychologic cluster membership before surgery and trajectories of ASES score over time adjusting for potential confounding variables. RESULTS: Two clusters were identified: one cluster (84 of 124 [68%]) had lower scores indicating better psychologic functioning and a second cluster (40 of 124 [32%]) had higher scores indicating poorer psychologic functioning. Accounting for all variables, the cluster with poorer psychologic functioning was found to be independently associated with worse ASES score at all time points (regression coefficient for ASES: before surgery -9 [95% confidence interval {CI}, -16 to -2], p = 0.011); 3 months after surgery -15 [95% CI, -23 to -8], p < 0.001); and 12 months after surgery -9 [95% CI, -17 to -1], p = 0.023). However, both clusters showed improvement in ASES score from before to 12 months after surgery, and there was no difference in the amount of improvement between clusters (regression coefficient for ASES: cluster with poorer psychologic function 31 [95% CI, 26-36], p < 0.001); cluster with better psychologic function 31 [95% CI, 23-39], p < 0.001). CONCLUSIONS: Patients who scored poorly on a range of psychologic measures before shoulder surgery displayed worse ASES scores at 3 and 12 months after surgery. Screening of psychologic factors before surgery is recommended to identify patients with poor psychologic function. Such patients may warrant additional behavioral or psychologic management before proceeding to surgery. However, further research is needed to determine the optimal management for patients with poorer psychologic function to improve pain and disability levels before and after surgery. LEVEL OF EVIDENCE: Level II, therapeutic study.

Are Psychosocial Factors Associated With Patient-reported Outcome Measures in Patients With Rotator Cuff Tears? A Systematic Review.

BACKGROUND: Psychosocial factors are key determinants of health and can influence patient-reported outcomes after rotator cuff tears. However, to our knowledge, a systematic review of published studies has not been conducted to determine the degree of consistency and strength of the relationship between psychosocial factors and patient-reported outcomes in this patient population. QUESTIONS/PURPOSES: (1) Are psychosocial factors associated with patient-reported measures at initial clinical presentation in patients with rotator cuff tears? (2) Are psychosocial factors associated with patient-reported outcomes after treatment in patients with rotator cuff tears? METHODS: A systematic review of cross-sectional and prospective observational studies was performed in MEDLINE/PubMed, EMBASE, CINAHL, PsycINFO, and Web of Science from each database's inception to June 2016. We included studies examining associations between psychosocial factors and patient-reported measures in patients with rotator cuff tears. We excluded studies not reporting on this relationship, involving patients with nonspecific shoulder pain, and written in a language other than English. Two independent reviewers performed the search, extracted information, and assessed methodological quality. Study quality was assessed using the Methodological Items for Non-Randomized Studies (MINORS) criteria. The primary outcomes for the review were associations between each psychosocial factor and patient-reported measures of function or disability, pain, or quality of life. Associations were interpreted based on significance, strength, and direction of the relationship. A total of 10 studies (five cross-sectional and five prospective) in 1410 patients (age range, 46-62 years, 60% [571 of 958] men) were included in the review. Pooling of results for meta-analyses was not possible as a result of study heterogeneity. RESULTS: Weak to moderate cross-sectional associations were found for emotional or mental health with function or disability and pain in multiple studies. Lower emotional or mental health function was associated with greater pain or disability or lower physical function at initial evaluation. Only one psychosocial factor (patient expectation) was weak to moderately associated with patient-reported outcomes after treatment in more than one study. In the two studies that examined expectations, the higher the expectation of benefit, the greater the perceived benefit after surgical intervention. CONCLUSIONS: At the initial evaluation of patients with rotator cuff tear, there was an association between self-reported function and pain and emotional or mental health. However, these factors were not associated with patient-reported outcomes after intervention. This finding could be attributed to the lack of large prospective studies in this area or complex phenotypes within this patient population. Preoperative patient expectation is an important predictor of patient-reported outcomes in patients after rotator cuff surgery and may be a modifiable target for enhancing recovery. LEVEL OF EVIDENCE: Level III, therapeutic study.