Utility of Patient Reported Outcome Measurement Information System measures in predicting shoulder arthroplasty in patients with shoulder osteoarthritis.

BACKGROUND: The decision to treat shoulder osteoarthritis (OA) definitively with shoulder arthroplasty (SA) is multifactorial, considering objective findings, subjective information, and patient goals. The first goal of this study was to determine if Patient Reported Outcome Measurement Information System (PROMIS) measures correlated with patients with shoulder OA who underwent SA within 1 year. The second goal of this study was to determine if score cut-offs in PROMIS domains could further discriminate which shoulder OA patients underwent SA within 1 year. METHODS: This retrospective case-control study examined patients with a diagnosis of shoulder OA who consulted an orthopedic provider from November 1, 2020 to May 23, 2022, and recorded PROMIS measures in the domains of Physical Function, Depression, and/or Pain Interference. A surgical group was defined as patients who underwent SA within 1 year of the most recent PROMIS measures and the nonsurgical patients were defined as the control group. Mean PROMIS scores were compared between the surgical and control groups. Separate logistic regression models controlling for age, race, ethnicity, and comorbidity count were performed for each PROMIS domain as a 1) continuous variable, and then as 2) binary variable defined by PROMIS score cut-off points to determine which scores correlated with undergoing SA to further characterize the potential clinical utility of PROMIS score cut-offs in relating to undergoing SA. RESULTS: The surgical group of 478 patients was older (68.2 vs. 63.8 years), more often of White race (82.6% vs. 70.9%), and less often of Hispanic Ethnicity (1.5% vs. 2.9%) than the control group of 3343 patients. Using optimal cut-offs in PROMIS scores, Pain Interference ≥63 (odds ratio [OR] = 2.97 (2.41-3.64), P < .001), Physical Function ≤39 (OR = 1.81 (95% confidence interval, 1.48-2.22), P < .001), and depression ≥49 (OR = 1.82 (95% confidence interval, 1.50-2.22), P < .001) were all found to correlate with undergoing SA within 1 year in multivariable logistic regressions. CONCLUSION: The results of this study demonstrate that cut-off scores for PROMIS measures differentiated patients undergoing SA within 1 year. These cut-off scores may have clinical utility in aiding in decision-making regarding surgical candidates for SA. Further research is needed to validate these cut-off scores and determine how they relate to patient outcomes after SA.

Effect of a Patient Engagement, Education, and Restructuring of Cognitions (PEERC) approach on conservative care in rotator cuff related shoulder pain treatment: a randomized control trial.

BACKGROUND: Despite similar outcomes for surgery and physical therapy (PT), the number of surgeries to treat rotator cuff related shoulder pain (RCRSP) is increasing. Interventions designed to enhance treatment expectations for PT have been shown to improve patient expectations, but no studies have explored whether such interventions influence patient reports of having had surgery, or being scheduled for surgery. The purpose of this randomized clinical trial was to examine the effect of a cognitive behavioral intervention aimed at changing expectations for PT on patient-report of having had or being scheduled for surgery and on the outcomes of PT. METHODS: The Patient Engagement, Education, and Restructuring of Cognitions (PEERC) intervention, was designed to change expectations regarding PT. PEERC was evaluated in a randomized, pragmatic "add-on" trial in by randomizing patients with RCRSP to receive either PT intervention alone (PT) or PT + PEERC. Fifty-four (54) individuals, recruited from an outpatient hospital-based orthopedic clinic, were enrolled in the trial (25 randomized to PT, 29 randomized to PT + PEERC). Outcomes assessed at enrollment, 6 weeks, discharge, and six months after discharge included the patient report of having had surgery, or being scheduled for surgery (primary) and satisfaction with PT outcome, pain, and function (secondary outcomes). RESULTS: The average age of the 54 participants was 51.81; SD = 12.54, and 63% were female. Chronicity of shoulder pain averaged 174.61 days; SD = 179.58. Study results showed that at the time of six months follow up, three (12%) of the participants in the PT alone group and one (3.4%) in the PT + PEERC group reported have had surgery or being scheduled for surgery (p = .32). There were no significant differences between groups on measures of satisfaction with the outcome of PT (p = .08), pain (p = .58) or function (p = .82). CONCLUSIONS: In patients with RCRSP, PT plus the cognitive behavioral intervention aimed at changing expectations for PT provided no additional benefit compared to PT alone with regard to patient report of having had surgery, or being scheduled to have surgery, patient reported treatment satisfaction with the outcome of PT, or improvements in pain, or function. TRIAL REGISTRATION: The trial is registered on ClinicalTrials.gov: NCT03353272 (27/11/2017).

Do You PROMIS (Patient Reported Outcomes Measurement Information System)? Physical Function and Pain Interference Scores After Total Knee and Hip Arthroplasty.

Background: Physical function and pain outcomes vary after arthroplasty. We investigated differences in postoperative Patient-Reported Outcomes Measurement Information System (PROMIS) physical function (PF) and pain interference (PI) scores for patients undergoing total knee arthroplasty (TKA) and total hip arthroplasty (THA). We aimed to identify preoperative factors that predict postoperative PROMIS scores. Methods: Patients who underwent TKA and THA from 2014-2020 were eligible. Preoperative variables including demographics, comorbidities, and pain scores were obtained from the medical record. Patients completed surveys measuring postoperative PF and PI. Descriptive statistics and separate linear regression models for each anatomical location were performed to examine factors predicting postoperative PROMIS PF and PI scores. Results: Surveys were completed by 2411 patients (19.5% response rate). Unadjusted mean PF postoperative scores were 47.2 for TKA and 48.8 for THA. Preoperative predictors of lower PF included female sex; body mass index and comorbidities for TKA and THA; and age, tobacco use, and non-White race for THA. Mean PI scores were 47.9 for THA and 49.0 for TKA. Preoperative predictors of increased PI included non-White race and increased body mass index for TKA and THA; higher preoperative pain for TKA; and female sex and increased comorbidity for THA. Conclusions: Postoperative PROMIS scores were similar for TKA and THA, with THA having slightly higher PF and lower PI scores. Regression models using preoperative variables showed similar performance for TKA compared with THA. These findings suggest areas for future development of clinical decision support tools.

Circulating Inflammatory Biomarkers Predict Pain Change Following Exercise-Induced Shoulder Injury: Findings From the Biopsychosocial Influence on Shoulder Pain Preclinical Trial.

Shoulder pain is a highly prevalent musculoskeletal condition that frequently leads to suboptimal clinical outcomes. This study tested the extent to which circulating inflammatory biomarkers are associated with reports of shoulder pain and upper-extremity disability for a high-risk genetic by psychological subgroup (catechol-O-methyltransferase [COMT] variation by pain catastrophizing [PCS]). Pain-free adults meeting high-risk COMT × PCS subgroup criteria completed an exercise-induced muscle injury protocol. Thirteen biomarkers were collected and analyzed from plasma 48 hours after muscle injury. Shoulder pain intensity and disability (Quick-DASH) were reported at 48 and 96 hours to calculate change scores. Using an extreme sampling technique, 88 participants were included in this analysis. After controlling for age, sex, and BMI, there were moderate positive associations between higher c-reactive protein (CRP; ߈ = .62; 95% confidence interval [CI] = -.03, 1.26), interleukin-6 (IL-6; ߈ = 3.13; CI = -.11, 6.38), and interleukin-10 (IL-10; ߈ = 2.51; CI = -.30, 5.32); and greater pain reduction from 48 to 96 hours post exercise muscle injury. Using an exploratory multivariable model to predict pain changes from 48 to 96 hours, we found participants with higher IL-10 were less likely to experience a high increase in pain (߈ = -10.77; CI = -21.25, -2.69). Study findings suggest CRP, IL-6, and IL-10 are related to shoulder pain change for a preclinical high-risk COMT × PCS subgroup. Future studies will translate to clinical shoulder pain and decipher the complex and seemingly pleiotropic interplay between inflammatory biomarkers and shoulder pain change. PERSPECTIVE: In a preclinical high-risk COMT × PCS subgroup, 3 circulating inflammatory biomarkers (CRP, IL-6, and IL-10) were moderately associated with pain improvement following exercise-induced muscle injury.

Can Patient-Reported Outcome Measurement Information System Measures Estimate High Impact Chronic Pain After Total Joint Arthroplasty?

BACKGROUND: High impact chronic pain (HICP) is not typically measured following orthopedic surgeries, but has a substantial negative impact on postoperative quality of life. This analysis determined which Patient-Reported Outcome Measurement Information System (PROMIS) measures accurately estimate HICP status following total joint arthroplasty (TJA). METHODS: This was a secondary analysis of a hip and knee TJA cohort. HICP status was determined by two items from the Graded Chronic Pain Scale-Revised. The cohort (n = 2,400) consisted of 47.5% hip (n = 1,142) and 52.5% knee TJA (n = 1,258). For total hip arthroplasty (THA), 53.7% were women (n = 615), 48.6% were 65 years or older (n = 557), 72.5% completed the survey more than 24 months after first surgery (n = 831), and 9.9% had HICP (n = 114). For total knee arthroplasty (TKA), 54.3% were women (n = 687), 59.3% were 65 years or older (n = 750), 72.3% survey completed the survey more than 24 months after first surgery (n = 915), and 11.5% had HICP (n = 145). Included PROMIS measures were pain interference, physical function, anxiety, and sleep disturbance. First, discriminant function analysis determined PROMIS measure contribution to HICP status. Then, area under the curve (AUC) calculated the accuracy of PROMIS measures to estimate HICP status. Influences of sociodemographic and surgical characteristics on AUC were explored in sensitivity analyses. RESULTS: Results for TKA and THA were similar so they are presented collectively for the sake of brevity. Mean differences were identified for all PROMIS measures for those with HICP (All P values < 0.01). Pain interference (ß = 0.934) and sleep disturbance (ß = 0.154) were independently correlated with HICP status in discriminant function analyses. The AUC (95% CIs) for HICP were as follows: pain interference (.952-.973), physical function (.921-.949), sleep (.780-.838), and anxiety (.687-.757). Sensitivity analyses revealed little change in AUC and HICP cutoff scores for PROMIS pain interference and physical function. CONCLUSION: Two PROMIS measures commonly administered as standard of care for orthopedics, pain interference, and physical function, can be used to estimate HICP status for THA and TKA, thereby refining assessment of TJA outcomes.

Back Pain Consortium (BACPAC): Protocol and Pilot Study Results for a Randomized Comparative-Effectiveness Trial of Antidepressants, Fear Avoidance Rehabilitation, or the Combination for Chronic Low Back Pain and Comorbid High Negative Affect.

OBJECTIVE: Patients with chronic low back pain (CLBP) and comorbid depression or anxiety disorders are highly prevalent. Negative affect (NA) refers to a combination of negative thoughts, emotions, and behaviors. Patients with CLBP with high NA have greater pain, worse treatment outcomes, and greater prescription opioid misuse. We present the protocol for SYNNAPTIC (SYNergizing Negative Affect & Pain Treatment In Chronic pain). DESIGN: A randomized comparative-effectiveness study of antidepressants, fear-avoidance rehabilitation, or their combination in 300 patients with CLBP with high NA. In the antidepressant- or rehabilitation-only arms, SYNNAPTIC includes an adaptive design of re-randomization after 4 months for nonresponders. SETTING: A multisite trial conducted in routine pain clinical treatment settings: pain clinics and physical and occupational therapy treatment centers. METHODS: Inclusion criteria include CLBP with elevated depression and anxiety symptoms. Antidepressant and rehabilitation treatments follow validated and effective protocols for musculoskeletal pain in patients with high NA. Power and sample size are based on superior outcomes of combination therapy with these same treatments in a 71-subject 4-arm pilot randomized controlled trial. CONCLUSIONS: SYNNAPTIC addresses the lack of evidence-based protocols for the treatment of the vulnerable subgroup of patients with CLBP and high NA. We hypothesize that combination therapy of antidepressants plus fear-avoidance rehabilitation will be more effective than each treatment alone. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04747314.

Treatment effect modifiers for individuals with acute low back pain: secondary analysis of the TARGET trial.

ABSTRACT: Treatment effect modifiers identify patient characteristics associated with treatment responses. The purpose of this secondary analysis was to identify potential treatment effect modifiers for disability from the TARGET trial that compared usual care (control) with usual care + psychologically informed physical therapy (PIPT). The sample consisted of a STarT Back tool identified high-risk patients with acute low back pain that completed Oswestry Disability Index (ODI) data at index visit and 6 months later (n = 1250). Candidate treatment effect modifiers were identified a priori and informed by the literature. Linear mixed models tested for treatment effect modification through tests of statistical interaction. All statistical interactions ( P ≤ 0.20) were stratified by modifier to inspect for specific effects ( P ≤ 0.05). Smoking was identified as a potential effect modifier (treatment * smoking interaction, P = 0.08). In participants who were smokers, the effect of PIPT was (ODI = 5.5; 95% CI: 0.6-10.4; P = 0.03) compared with usual care. In participants who were nonsmokers, the effect of PIPT was (ODI = 1.5; 95% CI: -1.4 to 4.4; P = 0.31) compared with usual care. Pain medication was also identified as a potential effect modifier (treatment × pain medication interaction, P = 0.10). In participants prescribed ≥3 pain medications, the effect of PIPT was (ODI = 7.1; 95% CI: -0.1 to 14.2; P = 0.05) compared with usual care. The PIPT effect for participants prescribed no pain medication was (ODI = 3.5; 95% CI: -0.4 to 7.4; P = 0.08) and for participants prescribed 1 to 2 pain medications was (ODI = 0.6; 95% CI: -2.5 to 3.7; P = 0.70) when compared with usual care. These findings may be used for generating hypotheses and planning future clinical trials investigating the effectiveness of tailored application of PIPT.

High-Impact Chronic Pain Transition in Lumbar Surgery Recipients.

OBJECTIVE: High-impact chronic pain (HICP) is a term that characterizes the presence of a severe and troubling pain-related condition. To date, the prevalence of HICP in lumbar spine surgery recipients and their HICP transitions from before to after surgery are unexplored. The purpose was to define HICP prevalence, transition types, and outcomes in lumbar spine surgery recipients and to identify predictors of HICP outcomes. METHODS: In total, 43,536 lumbar surgery recipients were evaluated for HICP transition. Lumbar spine surgery recipients were categorized as having HICP preoperatively and at 3 months after surgery if they exhibited chronic and severe pain and at least one major activity limitation. Four HICP transition groups (Stable Low Pain, Transition from HICP, Transition to HICP, and Stable High Pain) were categorized and evaluated for outcomes. Multivariate multinomial modeling was used to predict HICP transition categorization. RESULTS: In this sample, 15.1% of individuals exhibited HICP preoperatively; this value declined to 5.1% at 3 months after surgery. Those with HICP at baseline and 3 months had more comorbidities and worse overall outcomes. Biological, psychological, and social factors predicted HICP transition or Stable High Pain; some of the strongest involved social factors of 2 or more to transition to HICP (OR = 1.43; 95% CI = 1.21-1.68), and baseline report of pain/disability (OR = 3.84; 95% CI = 3.20-4.61) and psychological comorbidity (OR = 1.78; 95% CI = 1.48-2.12) to Stable Stable High Pain. CONCLUSION: The percentage of individuals with HICP preoperatively (15.1%) was low, which further diminished over a 3-month period (5.1%). Postoperative HICP groups had higher levels of comorbidities and worse baseline outcomes scores. Transition to and maintenance of HICP status was predicted by biological, psychological, and social factors.

Sleep disturbance, dyspnea, and anxiety following total joint arthroplasty: an observational study.

BACKGROUND: Patient-Reported Outcomes Measurement Information System (PROMIS) domains for sleep disturbance, anxiety, and dyspnea have been under-reported for total joint arthroplasty (TJA). The aims of this study were to report postoperative differences for these domains based on TJA location and chronic pain state. We also investigated whether these domains were associated with physical function and pain interference outcomes. METHODS: This was a retrospective, observational study of patients who underwent hip, knee, or shoulder TJA (primary and revision surgeries) at a single academic tertiary referral center. A subset of these patients completed an email-based survey for chronic pain grade (Chronic Pain Grade Scale-Revised) and sleep disturbance, anxiety, dyspnea, physical function, and pain interference (PROMIS short forms). Pre-operative and operative data were extracted from the electronic health record. Data analysis investigated PROMIS domains for differences in TJA location and chronic pain grade. Hierarchical linear regression determined associations of these domains with physical function and pain interference. RESULTS: A total of 2638 individuals provided informed consent and completed the email survey. In the ANOVA models for sleep disturbance, anxiety, and dyspnea, there was no location by chronic pain grade interaction (p > 0.05) and no difference based on TJA location (p > 0.05). There were differences for chronic pain grade (p < 0.01). The poorest postoperative outcome score for each domain was associated with high impact chronic pain. Furthermore, sleep disturbance and dyspnea had the strongest associations with physical function and pain interference (p < 0.01). CONCLUSIONS: Sleep disturbance, anxiety, and dyspnea did not vary based on TJA location, but were associated with postoperative chronic pain grade. Sleep disturbance and dyspnea were strongly associated with commonly reported outcomes of physical function and pain interference. These findings provide guidance for those interested in expanding TJA outcome assessment to include sleep disturbance, anxiety, and/or dyspnea.

Can Patient-Reported Outcome Measurement Information System Measures Differentiate Patients Who Will Undergo Hip and Knee Total Joint Arthroplasty: A Retrospective Case-Control Study.

BACKGROUND: The Patient-Reported Outcome Measurement Information System (PROMIS) can be used to monitor patients in population-health-based programs. However, it is unknown which measures are most appropriate to differentiate patients who will undergo hip or knee total joint arthroplasty (TJA) in a cohort of patients with osteoarthritis. METHODS: A retrospective cohort of new patients consulting for treatment from November 17, 2017 to April 20, 2020 (cases: hip: n = 157, knee: n = 112; randomly selected nonsurgical controls: hip: n = 314, knee: n = 224) was extracted from the electronic health record. We recorded demographics, comorbidity, and PROMIS scores for 8 domains (physical function, pain interference, pain intensity, anxiety, depression, sleep disturbance, ability to participate in social roles and activities, and fatigue). We performed descriptive statistics to characterize the cohorts and baseline PROMIS scores and conducted logistic regression models to determine which PROMIS domains differentiated patients undergoing hip and knee TJA. RESULTS: In univariate comparisons of PROMIS domains, the hip and knee surgical cohorts differed from controls in physical function (P < .01), pain interference (P < .01), and ability to participate in social roles and activities (P < .02). In logistic regression models informed by univariate analyses, PROMIS physical function was the only PROMIS measure to differentiate undergoing surgery in both hip and knee cohorts (P < .01). CONCLUSION: PROMIS physical function can differentiate TJA cases from nonsurgical controls in both hip and knee patients. These findings have implications for considering which PROMIS measures to administer in patients with hip and knee osteoarthritis.

Low Risk for Persistent Back Pain Disability Is Characterized by Lower Pain Sensitivity and Higher Physical Performance.

OBJECTIVE: The STarT Back Tool (SBT) predicts risk for persistent low back pain (LBP)-related disability based on psychological distress levels. Other non-psychological factors associated with LBP, such as pain sensitivity and physical performance, may further characterize SBT-risk subgroups. The purpose of this study was to determine whether a low-risk SBT subgroup demonstrated lower pain sensitivity and/or higher physical performance compared with a medium-/high-risk SBT subgroup. METHODS: In this cross-sectional, secondary analysis, adults with LBP (N = 76) completed SBT and demographics (age, sex, race, chronicity) questionnaires. Participants underwent pain sensitivity (local and remote pressure pain thresholds, temporal summation, conditioned pain modulation) and physical performance (Back Performance Scale, walking speed, obstacle negotiation, Timed "Up & Go" [TUG], TUG Cognitive) testing. Independent samples t tests determined low- versus medium-/high-risk SBT subgroup differences. A follow-up discriminant function analysis was also conducted. RESULTS: The medium-/high-risk subgroup demonstrated a lower proportion of participants with acute pain. The low-risk subgroup demonstrated lower pain sensitivity (higher local pressure pain thresholds and higher conditioned pain modulation) and higher physical performance (superior Back Performance Scale scores, faster walking speeds, faster obstacle approach and crossing speeds, and faster TUG completion). Discriminant function analysis results supported the 2-subgroup classification and indicated strong to moderate relationships with obstacle crossing speed, chronicity, and conditioned pain modulation. CONCLUSION: Lower pain sensitivity and higher physical performance characterized the low-risk SBT subgroup and may represent additional LBP prognostic factors associated with persistent disability. Longitudinal studies are needed to confirm whether these factors can enhance SBT prediction accuracy and further direct treatment priorities. IMPACT: Sensory and physical factors contribute to SBT risk classification, suggesting additional, non-psychological factors are indicative of favorable LBP outcomes. Findings highlight the need for assessment of multiple factors to improve LBP clinical prediction. LAY SUMMARY: People at low risk for back pain disability have less sensitivity to pain and better physical performance. By measuring these factors, physical therapists could guide treatment and improve outcomes for people with back pain.

High-impact chronic pain transition in surgical recipients with cervical spondylotic myelopathy.

OBJECTIVE: High-impact chronic pain (HICP) is a recently proposed metric that indicates the presence of a severe and troubling pain-related condition. Surgery for cervical spondylotic myelopathy (CSM) is designed to halt disease transition independent of chronic pain status. To date, the prevalence of HICP in individuals with CSM and their HICP transition from presurgery is unexplored. The authors sought to define HICP prevalence, transition, and outcomes in patients with CSM who underwent surgery and identify predictors of these HICP transition groups. METHODS: CSM surgical recipients were categorized as HICP at presurgery and 3 months if they exhibited pain that lasted 6-12 months or longer with at least one major activity restriction. HICP transition groups were categorized and evaluated for outcomes. Multivariate multinomial modeling was used to predict HICP transition categorization. RESULTS: A majority (56.1%) of individuals exhibited HICP preoperatively; this value declined to 15.9% at 3 months (71.6% reduction). The presence of HICP was also reflective of other self-reported outcomes at 3 and 12 months, as most demonstrated notable improvement. Higher severity in all categories of self-reported outcomes was related to a continued HICP condition at 3 months. Both social and biological factors predicted HICP translation, with social factors being predominant in transitioning to HICP (from none preoperatively). CONCLUSIONS: Many individuals who received CSM surgery changed HICP status at 3 months. In a surgical population where decisions are based on disease progression, most of the changed status went from HICP preoperatively to none at 3 months. Both social and biological risk factors predicted HICP transition assignment.

Chronic Pain Prevalence and Factors Associated With High Impact Chronic Pain following Total Joint Arthroplasty: An Observational Study.

Hip, knee, and shoulder arthroplasty are among the most frequently performed orthopaedic procedures in the United States. High impact and bothersome chronic pain rates following total joint arthroplasty (TJA) are unknown; as are factors that predict these chronic pain outcomes. This retrospective observational study included individuals that had a TJA from January 2014 to January 2020 (n = 2,638). Pre-operative and clinical encounter information was extracted from the electronic health record and chronic pain state was determined by email survey. Predictor variables included TJA location, number of surgeries, comorbidities, tobacco use, BMI, and pre-operative pain intensity. Primary outcomes were high impact and bothersome chronic pain. Rates of high impact pain (95% CI) were comparable for knee (9.8-13.3%), hip (8.3-11.8%) and shoulder (7.6-16.3%). Increased risk of high impact pain included non-white race, two or more comorbidities, age less than 65 years, pre-operative pain scores 5/10 or higher, knee arthroplasty, and post-operative survey completion 24 months or less. Rates of bothersome chronic pain (95% CI) were also comparable for knee (24.9-29.9%) and hip (21.3-26.3%) arthroplasty; but higher for shoulder (26.9-39.6%). Increased risk of bothersome chronic pain included non-white race, shoulder arthroplasty, knee arthroplasty, current or past tobacco use, and being female. PERSPECTIVE: In this cohort more than 1/3rd of individuals reported high impact or bothersome chronic pain following TJA. Non-white race and knee arthroplasty were the only two variables associated with both chronic pain outcomes.

Patient-centered outcomes: Domain importance predicts health care use following physical therapy.

INTRODUCTION: Identifying patients with musculoskeletal pain who are at risk for additional health care use is important for improving the value of physical therapists' services. We previously identified three subgroups based on the importance attached by patients to improvements in outcome domains including a (1) Pain and Function Outcomes Important subgroup; (2) Pain Important subgroup; and (3) Multiple Outcome Domains Important subgroup. OBJECTIVE: The primary aim was to determine whether subgroups based on patient-determined outcomes of importance predicted any additional pain-related health care use after an episode of physical therapy. A secondary aim was to determine if subgroup membership predicted use of specific services. DESIGN: Secondary analysis of a longitudinal cohort. SETTING: Ambulatory outpatient physical therapy clinics. PATIENTS: Two hundred forty-six patients seeking physical therapy recruited from the Optimal Screening for Prediction of Referral and Outcome (OSPRO) cohort study. INTERVENTIONS: Patients completed a demographic and health history questionnaire, numeric pain rating scale, region-specific disability measure, and Charlson Comorbidity Index. Subgroup membership was determined based on responses to the Patient Centered Outcome Questionnaire. At 1 year, patients reported use of health care since discharge from physical therapy. Separate logistic regression models determined whether subgroup membership predicted additional health care use. RESULTS: Compared to the Pain and Function Outcomes Important subgroup, the Pain Important subgroup had higher adjusted odds (95% confidence interval [CI]) for the primary outcome of any additional health care use (adjusted odds ratio [aOR] 2.47, 95% CI 1.01-6.00) and secondary outcomes of opioid use (aOR 9.45, 95% CI 2.87-31.17), injection (aOR 4.09, 95% CI 1.25-13.41), and surgery (aOR 5.10, 95% CI 1.15-22.67). There were no significant differences in health care utilization between the Pain and Function Outcomes Important and Multiple Outcome Domains Important subgroups. CONCLUSION: In this cohort, patients with a singular focus on pain improvements were at higher risk for additional health care, including opioid use, injection, and surgery. These findings are exploratory and need to be confirmed in other cohorts.

Development of Reliable and Valid Negative Mood Screening Tools for Orthopaedic Patients with Musculoskeletal Pain.

BACKGROUND: Negative mood is an important risk factor for poor clinical outcomes among individuals with musculoskeletal pain. Screening for negative mood can aid in identifying those who may need additional psychological interventions. Limitations of current negative mood screening tools include (1) high response burden, (2) a focus on single dimensions of negative mood, (3) poor precision for identifying individuals with low or high negative mood levels, and/or (4) design not specific for use in populations with orthopaedic conditions and musculoskeletal pain. QUESTIONS/PURPOSES: (1) Can item response theory methods be used to construct screening tools for negative mood (such as depression, anxiety, and anger) in patients undergoing physical therapy for orthopaedic conditions? (2) Do these tools demonstrate reliability and construct validity when used in a clinical setting? METHODS: This was a cross-sectional study involving outpatients having physical therapy in tertiary-care settings. A total of 431 outpatients with neck (n = 93), shoulder (n = 108), low back (n = 119), or knee (n = 111) conditions were enrolled between December 2014 and December 2015, with 24% (103 of 431) seeking care after orthopaedic surgery. Participants completed three validated psychological questionnaires measuring negative mood, resulting in 39 candidate items for item response theory analysis. Factor analysis was used to identify the dimensions (factors) assessed by the candidate items and select items that loaded on the main factor of interest (negative mood), establishing a unidimensional item set. Unidimensionality of an item set suggests they are assessing one main factor or trait, allowing unbiased score estimates. The identified items were assessed for their fit to the graded item response theory model. This model allows for items to vary by the level of difficulty they represent and by their ability to discriminate between patients at different levels of the trait being assessed, in this case, negative mood. Finally, a hierarchical bifactor model where multiple subfactors are allowed to load on an overall factor was used to confirm that the items identified as representing a unidimensional item set explained the large majority of variance of the overall factor, providing additional support for essential unidimensionality. Using the final item bank, we constructed a computer adaptive test administration mode, and reduced item sets were selected to create short forms including items with the highest information (reliability) at targeted score levels of the trait being measured, while also considering clinical content. RESULTS: We identified a 12-item bank for assessment of negative mood; eight-item and four-item short-form versions were developed to reduce administrative burden. Computer adaptive test administration used a mean ± SD of 8 ± 1 items. The item bank's reliability (0 = no reliability; 1 = perfect reliability) was 0.89 for the computer adaptive test administration, 0.86 for the eight-item short form, and 0.71 for the four-item short form. Reliability values equal to or greater than 0.7 are considered acceptable for group level measures. Construct validity sufficient for clinical practice was supported by more severe negative mood scores among individuals with a previous episode of pain in the involved anatomical region, pain and activity limitations during the past 3 months, a work-related injury, education less than a college degree, and income less than or equal to USD 50,000. CONCLUSION: These newly derived tools include short-form and computer adaptive test options for reliable and valid negative mood assessment in outpatient orthopaedic populations. Future research should determine the responsiveness of these measures to change and establish score thresholds for clinical decision-making. CLINICAL RELEVANCE: Orthopaedic providers can use these tools to inform prognosis, establish clinical benchmarks, and identify patients who may benefit from psychological and/or behavioral treatments.

Heterogeneity of pain-related psychological distress in patients seeking care for shoulder pathology.

BACKGROUND: Psychological distress is associated with disability and quality of life for patients with shoulder pain. However, uncertainty around heterogeneity of psychological distress has limited the adoption of shoulder care models that address psychological characteristics. In a cohort of patients with shoulder pain, our study sought to (1) describe the prevalence of various subtypes of psychological distress; (2) evaluate associations between psychological distress and self-reported shoulder pain, disability, and function; and (3) determine differences in psychological distress profiles between patients receiving nonoperative vs. operative treatment. METHODS: The sample included 277 patients who were evaluated in clinic by a shoulder surgeon and completed the Optimal Screening for Prediction of Referral and Outcome Yellow Flag Assessment Tool (OSPRO-YF) from 2019 to 2021. This tool categorizes maladaptive and adaptive psychological traits, and the number of yellow flags (YFs) ranges from 0 to 11, with higher YF counts indicating higher pain-related psychological distress. Operative and nonoperative cohorts were compared using χ2 test and Student t test. Linear regression was used to evaluate the association between pain, disability, and YFs, whereas Poisson regression evaluated the association between operative treatment and psychological distress. K-means cluster analysis was performed to propose potential psychological distress phenotypes. RESULTS: Two hundred fifty-one patients (91%) had at least 1 YF on the OSPRO-YF tool, with a mean number of 6 ± 3.5 YFs. YFs in unhelpful coping (85%) and helpful coping domains (78%) were most prevalent. The number of YFs was significantly associated with baseline shoulder pain (P < .001), Single Assessment Numeric Evaluation (P < .001), and American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (P < .001) scores. Comparing operative and nonoperative cohorts, the operative cohort had a significantly higher mean number of YFs (6.5 vs. 5.6, P = .035), presence of any YF (94.3% vs. 85.7%, P = .015), and presence of YFs within the unhelpful coping domain (91.8% vs. 75.6%, P < .001). Three phenotypes were described, corresponding to low, moderate, and severe psychological distress (P < .001), with females (P = .037) and smokers (P = .018) associated with higher psychological distress phenotypes. CONCLUSIONS: YFs, particularly within the unhelpful coping and helpful coping domains, were highly prevalent in a cohort of patients presenting to a shoulder surgeon's clinic. Additionally, operative patients were found to have a significantly higher rate of YFs across multiple dimensions of psychological distress. These findings stress the importance of routine attentiveness to multiple dimensions of pain-related psychological distress in shoulder populations, which can provide an opportunity to reinforce healthy interpretation of pain while minimizing distress in appropriately identified patients.

Opioid legislation and narcotic filling in total hip arthroplasty: descriptive study of time and state-level trends in the United States.

BACKGROUND: The opioid misuse epidemic focused national attention on reducing opioid overprescribing. The purpose of this study is to describe the relationship of time and state-level interventions and opioid filling surrounding total hip arthroplasty (THA) in the United States. METHODS: A national database with diverse insurance constituents was queried for first-prescription and cumulative perioperative opioid filling volumes and rates in oxycodone 5-mg equivalents (OE's) in 487,942 patients undergoing primary THA from 30-days pre-operative to 90-days post-operative. Descriptive statistics evaluated pre-legislative and post-legislative opioid filling by state, legislative type, and surgery year. RESULTS: At the national level, initial opioid filling volumes have remained largely unchanged (56.2 OE's in 2010 to 51.7 OE's in 2018). Meanwhile, cumulative opioid filling volumes (151.9 OE's in 2010 to 111.7 OE's in 2018) have decreased considerably. Rates of initial opioid prescriptions exceeding 90 OE's were similar in 2010 (6.4%) and 2018 (5.6%). States with legislation targeting duration and volume of opioid prescriptions saw the largest decreases in opioid prescription filling. That is, 75% of states with opioid legislation had large (> 10 oxycodone 5-mg equivalents) decreases in cumulative 90-day opioid filling compared to only 20% of states without opioid legislation having large decreases in cumulative 90-day opioid filling. CONCLUSIONS: This descriptive study demonstrates decreases in perioperative opioid filling for THA. Although this study was descriptive in nature, states enacting opioid-limiting legislation had larger decreases. Although causal relationships could not be inferred from this analysis, the results suggest that states without legislation could improve prescriber compliance with national goals of decreased opioid overprescribing by enacting opioid-limiting legislation. LEVEL OF EVIDENCE: Level III, retrospective prognostic cohort study.

The influence of a cognitive behavioural approach on changing patient expectations for conservative care in shoulder pain treatment: a protocol for a pragmatic randomized controlled trial.

BACKGROUND: Despite similar outcomes for surgery and conservative care, the number of surgeries to treat rotator cuff related shoulder pain has increased. Interventions designed to enhance treatment expectations for conservative care have been shown to improve patient expectations, but no studies have yet explored whether such interventions influence patient decisions to pursue surgery. The purpose of this randomized clinical trial is to examine the effect of an intervention designed to improve expectations of conservative care on the decision to have surgery. METHODS: We will test the effectiveness of the Patient Engagement, Education, and Restructuring of Cognitions (PEERC) intervention which is intended to change expectations regarding conservative care. The PEERC intervention will be evaluated in a randomized, pragmatic "add-on" trial, to better understand the effect the intervention has on outcomes. Ninety-four (94) participants with rotator cuff related shoulder pain referred for physical therapy will be randomized to receive either impairment-based care or impairment-based care plus PEERC. Both groups will receive impairment-based conservative treatment created by compiling the evidence associated with established, effective interventions. Participants assigned to the impairment-based care plus PEERC condition will also receive the PEERC intervention. This intervention, informed by principles of cognitive behavioral therapy, involves three components: (1) strategies to enhance engagement, (2) education and (3) cognitive restructuring and behavioral activation. Outcomes will be assessed at multiple points between enrolment and six months after discharge. The primary outcome is patient reported decision to have surgery and the secondary outcomes are pain, function, expectations and satisfaction with conservative care. DISCUSSION: Rotator cuff related shoulder pain is highly prevalent, and because conservative and surgical treatments have similar outcomes, an intervention that changes expectations about conservative care could alter patient reports of their decision to have surgery and ultimately could lead to lower healthcare costs and decreased risk of surgical complications. TRIAL REGISTRATION: This study is registered as NCT03353272 at ClincialTrials.gov.

Can PROMIS measures be used to create subgroups for patients seeking orthopaedic care?

AIMS: Patient-reported outcome measures have become an important part of routine care. The aim of this study was to determine if Patient-Reported Outcomes Measurement Information System (PROMIS) measures can be used to create patient subgroups for individuals seeking orthopaedic care. METHODS: This was a cross-sectional study of patients from Duke University Department of Orthopaedic Surgery clinics (14 ambulatory and four hospital-based). There were two separate cohorts recruited by convenience sampling (i.e. patients were included in the analysis only if they completed PROMIS measures during a new patient visit). Cohort #1 (n = 12,141; December 2017 to December 2018,) included PROMIS short forms for eight domains (Physical Function, Pain Interference, Pain Intensity, Depression, Anxiety, Sleep Quality, Participation in Social Roles, and Fatigue) and Cohort #2 (n = 4,638; January 2019 to August 2019) included PROMIS Computer Adaptive Testing instruments for four domains (Physical Function, Pain Interference, Depression, and Sleep Quality). Cluster analysis (K-means method) empirically derived subgroups and subgroup differences in clinical and sociodemographic factors were identified with one-way analysis of variance. RESULTS: Cluster analysis yielded four subgroups with similar clinical characteristics in Cohort #1 and #2. The subgroups were: 1) Normal Function: within normal limits in Physical Function, Pain Interference, Depression, and Sleep Quality; 2) Mild Impairment: mild deficits in Physical Function, Pain Interference, and Sleep Quality but with Depression within normal limits; 3) Impaired Function, Not Distressed: moderate deficits in Physical Function and Pain Interference, but within normal limits for Depression and Sleep Quality; and 4) Impaired Function, Distressed: moderate (Physical Function, Pain Interference, and Sleep Quality) and mild (Depression) deficits. CONCLUSION: These findings suggest orthopaedic patient subgroups differing in physical function, pain, and psychosocial distress can be created from as few as four different PROMIS measures. Longitudinal research is necessary to determine whether these subgroups have prognostic validity. Cite this article: Bone Jt Open 2021;2(7):493-502.