Statistical modeling of acute and chronic pain patient-reported outcomes obtained from ecological momentary assessment.

ABSTRACT: Ecological momentary assessment (EMA) allows for the collection of participant-reported outcomes (PROs), including pain, in the normal environment at high resolution and with reduced recall bias. Ecological momentary assessment is an important component in studies of pain, providing detailed information about the frequency, intensity, and degree of interference of individuals' pain. However, there is no universally agreed on standard for summarizing pain measures from repeated PRO assessment using EMA into a single, clinically meaningful measure of pain. Here, we quantify the accuracy of summaries (eg, mean and median) of pain outcomes obtained from EMA and the effect of thresholding these summaries to obtain binary clinical end points of chronic pain status (yes/no). Data applications and simulations indicate that binarizing empirical estimators (eg, sample mean, random intercept linear mixed model) can perform well. However, linear mixed-effect modeling estimators that account for the nonlinear relationship between average and variability of pain scores perform better for quantifying the true average pain and reduce estimation error by up to 50%, with larger improvements for individuals with more variable pain scores. We also show that binarizing pain scores (eg, <3 and ≥3) can lead to a substantial loss of statistical power (40%-50%). Thus, when examining pain outcomes using EMA, the use of linear mixed models using the entire scale (0-10) is superior to splitting the outcomes into 2 groups (<3 and ≥3) providing greater statistical power and sensitivity.

Patient and Operational Factors Do Not Substantively Affect the Annual Departmental Quality of Anesthesiologists' Clinical Supervision and Nurse Anesthetists' Work Habits.

INTRODUCTION: Although safety climate, teamwork, and other non-technical skills in operating rooms probably influence clinical outcomes, direct associations have not been shown, at least partially due to sample size considerations. We report data from a retrospective cohort of anesthesia evaluations that can simplify the design of prospective observational studies in this area. Associations between non-technical skills in anesthesia, specifically anesthesiologists' quality of clinical supervision and nurse anesthetists' work habits, and patient and operational factors were examined. METHODS: Eight fiscal years of evaluations and surgical cases from one hospital were included. Clinical supervision by anesthesiologists was evaluated daily using a nine-item scale. Work habits of nurse anesthetists were evaluated daily using a six-item scale. The dependent variables for both groups of staff were binary, whether all items were given the maximum score or not. Associations were tested with patient and operational variables for the entire day. RESULTS: There were 40,718 evaluations of faculty anesthesiologists by trainees, 53,772 evaluations of nurse anesthetists by anesthesiologists, and 296,449 cases that raters and ratees started together. Cohen's d values were small (≤0.10) for all independent variables, suggesting a lack of any clinically meaningful association between patient and operational factors and evaluations given the maximum scores. For supervision quality, the day's count of orthopedic cases was a significant predictor of scores (P = 0.0011). However, the resulting absolute marginal change in the percentage of supervision scores equal to the maximum was only 0.8% (99% confidence interval: 0.2% to 1.4%), i.e., too small to be of clinical or managerial importance. Neurosurgical cases may have been a significant predictor of work habits (P = 0.0054). However, the resulting marginal change in the percentage of work habits scores equal to the maximum, an increase of 0.8% (99% confidence interval: 0.1% to 1.6%), which was again too small to be important. CONCLUSIONS: When evaluating the effect of assigning anesthesiologists and nurse anesthetists with different clinical performance quality on clinical outcomes, supervision quality and work habits scores may be included as independent variables without concern that their effects are confounded by association with the patient or case characteristics. Clinical supervision and work habits are measures of non-technical skills. Hence, these findings suggest that non-technical performance can be judged by observing the typical small sample size of cases. Then, associations can be tested with administrative data for a far greater number of patients because there is unlikely to be a confounding association between patient and case characteristics and the clinicians' non-technical performance.

Minimal Clinically Important Change of Movement Pain in Musculoskeletal Pain Conditions.

Movement pain, which is distinct from resting pain, is frequently reported by individuals with musculoskeletal pain. There is growing interest in measuring movement pain as a primary outcome in clinical trials, but no minimally clinically important change (MCIC) has been established, limiting interpretations. We analyzed data from 315 participants who participated in previous clinical trials (65 with chronic Achilles tendinopathy; 250 with fibromyalgia) to establish an MCIC for movement pain. A composite movement pain score was defined as the average pain (Numeric Rating Scale: 0-10) during 2 clinically relevant activities. The change in movement pain was calculated as the change in movement pain from pre-intervention to post-intervention. A Global Scale (GS: 1-7) was completed after the intervention on perceived change in health status. Participants were dichotomized into non-responders (GS ≥4) and responders (GS <3). Receiver operating characteristic curves were calculated to determine threshold values and corresponding sensitivity and specificity. We used the Euclidean method to determine the optimal threshold point of the Receiver operating characteristic curve to determine the MCIC. The MCIC for raw change in movement pain was 1.1 (95% confidence interval [CI]: .9-1.6) with a sensitivity of .83 (95% CI: .75-.92) and specificity of .79 (95% CI: .72-.86). For percent change in movement pain the MCIC was 27% (95% CI: 10-44%) with a sensitivity of .79 (95% CI: .70-.88) and a specificity of .82 (95% CI: .72-.90). Establishing an MCIC for movement pain will improve interpretations in clinical practice and research. PERSPECTIVE: A minimal clinically important change (MCIC) of 1.1- points (95% CI: .9-1.6) for movement pain discriminates between responders and non-responders to rehabilitation. This MCIC provides context for interpreting the meaningfulness of improvement in pain specific to movement tasks.

Introduction to Bayesian Analyses for Clinical Research.

Bayesian analyses are becoming more popular as a means of analyzing data, yet the Bayesian approach is novel to many members of the broad clinical audience. While Bayesian analyses are foundational to anesthesia pharmacokinetic/pharmacodynamic modeling, they also can be used for analyzing data from clinical trials or observational studies. The traditional null hypothesis significance testing (frequentist) approach uses only the data collected from the current study to make inferences. On the other hand, the Bayesian approach quantifies the external information or expert knowledge and combines the external information with the study data, then makes inference from this combined information. We introduce to the clinical and translational science researcher what it means to do Bayesian statistics, why a researcher would choose to perform their analyses using the Bayesian approach, when it would be advantageous to use a Bayesian instead of a frequentist approach, and how Bayesian analyses and interpretations differ from the more traditional frequentist methods. Throughout this paper, we use various pain- and anesthesia-related examples to highlight the ideas and statistical concepts that should be relatable to other areas of research as well.

Physical Activity Among Rural Men: Barriers and Preferences.

INTRODUCTION: Physical activity positively affects health. Although 94% of Americans know the health benefits of regular physical activity, more than 75% do not achieve recommended levels. The objective of our study was to identify and define the key components of a physical activity intervention tailored to rural American men. METHODS: We recruited rural men (N = 447) via Amazon's Mechanical Turk online platform to complete a needs assessment survey focused on their interest in a physical activity intervention, preferred intervention features, and potential intervention objectives. Data were summarized by using descriptive statistics. A cumulative logistic regression model examined associations between the men's perceived importance of physical activity to health and their interest in a physical activity intervention. RESULTS: Almost all participants (97.7%) rated physical activity as "at least somewhat important" to their health, and 83.9% indicated they would be "at least somewhat interested" in participating in a physical activity intervention. On a scale of 1 (not at all a barrier) to 5 (very much a barrier), motivation (mean 3.4; 95% CI, 3.3-3.5), cold weather (mean, 3.4; 95% CI, 3.3-3.5), and tiredness (mean, 3.3; 95% CI, 3.2-3.4) were rated the biggest barriers to physical activity. Becoming fitter (54.1%) was the top reason for joining a physical activity program. Preferred delivery channels for receiving an intervention were mobile application (ranked from 1 being the most preferred and 9 being the least preferred: mean, 2.8; 95% CI, 2.70-3.09) and e-mail (mean, 4.2; 95% CI, 3.92-4.36). Rural men preferred interventions that taught them how to exercise and that could be done from home. CONCLUSION: Our findings suggest US men in rural areas are receptive to physical activity programs. A systematic approach and a clear model of development are needed to tailor future physical activity interventions to the special needs of rural men.

Patterns of movement-evoked pain during tendon loading and stretching tasks in Achilles tendinopathy: A secondary analysis of a randomized controlled trial.

BACKGROUND: This study aimed to characterize movement-evoked pain during tendon loading and stretching tasks in individuals with Achilles tendinopathy, and to examine the association between movement-evoked pain with the Achilles tendinopathy type (insertional and midportion), biomechanical, and psychological variables. METHODS: In this laboratory-based, cross-sectional study, 37 individuals with chronic Achilles tendinopathy participated. Movement-evoked pain intensity (Numeric Rating Scale: 0 to 10) and sagittal-plane ankle biomechanics were collected simultaneously during standing, fast walking, single-leg heel raises, and weight-bearing calf stretch. Description of symptoms, including location of Achilles tendon pain and duration of tendon morning stiffness, as well as pain-related psychological measures, including the Tampa Scale of Kinesiophobia were collected. Linear mixed effects models were built around two paradigms of movement-evoked pain (tendon loading and stretching tasks) with each model anchored with pain at rest. FINDINGS: Movement-evoked pain intensity increased as task demand increased in both models. Lower peak dorsiflexion with walking (ß = -0.187, 95% CI: -0.305, -0.069), higher fear of movement (ß = 0.082, 95% CI: 0.018, 0.145), and longer duration of tendon morning stiffness (ß = 0.183, 95% CI: 0.07, 0.296) were associated with greater pain across tendon loading tasks (R2 = 0.47). Lower peak dorsiflexion with walking (ß = -0.27, 95% CI: -0.41, -0.14), higher dorsiflexion with the calf stretch (ß = 0.095, 95% CI: 0.02, 0.16), and insertional Achilles tendinopathy (ß = -0.93, 95% CI: -1.65, -0.21) were associated with higher pain across tendon stretching tasks (R2 = 0.53). INTERPRETATION: In addition to exercise, the ideal management of Achilles tendinopathy may require adjunct treatments to address the multifactorial aspects of movement-evoked pain.

Predicting chronic postsurgical pain: current evidence and a novel program to develop predictive biomarker signatures.

ABSTRACT: Chronic pain affects more than 50 million Americans. Treatments remain inadequate, in large part, because the pathophysiological mechanisms underlying the development of chronic pain remain poorly understood. Pain biomarkers could potentially identify and measure biological pathways and phenotypical expressions that are altered by pain, provide insight into biological treatment targets, and help identify at-risk patients who might benefit from early intervention. Biomarkers are used to diagnose, track, and treat other diseases, but no validated clinical biomarkers exist yet for chronic pain. To address this problem, the National Institutes of Health Common Fund launched the Acute to Chronic Pain Signatures (A2CPS) program to evaluate candidate biomarkers, develop them into biosignatures, and discover novel biomarkers for chronification of pain after surgery. This article discusses candidate biomarkers identified by A2CPS for evaluation, including genomic, proteomic, metabolomic, lipidomic, neuroimaging, psychophysical, psychological, and behavioral measures. Acute to Chronic Pain Signatures will provide the most comprehensive investigation of biomarkers for the transition to chronic postsurgical pain undertaken to date. Data and analytic resources generatedby A2CPS will be shared with the scientific community in hopes that other investigators will extract valuable insights beyond A2CPS's initial findings. This article will review the identified biomarkers and rationale for including them, the current state of the science on biomarkers of the transition from acute to chronic pain, gaps in the literature, and how A2CPS will address these gaps.

Efficacy of Telehealth for Movement-Evoked Pain in People With Chronic Achilles Tendinopathy: A Noninferiority Analysis.

OBJECTIVE: The purpose of this study was to compare the efficacy of physical therapy delivered via an all telehealth or hybrid format with an all in-person format on movement-evoked pain for individuals with chronic Achilles tendinopathy (AT). METHODS: Sixty-six individuals with chronic AT participated (age, 43.4 [SD = 15.4] years; 56% female; body mass index, 29.9 [SD = 7.7] kg/m2). Participants completed all in-person visits from the initiation of recruitment in September 2019 to March 16, 2020 (in-person group). From March 17 to July 15, 2020, participants completed all telehealth visits (telehealth group). From July 16, 2020, to enrollment completion in December 2020, participants could complete visits all in-person, all telehealth, or a combination of in-person and telehealth (hybrid group) based on their preference. A physical therapist provided 6 to 7 visits, including an exercise program and patient education. Noninferiority analyses of the telehealth and hybrid groups compared with the in-person group were completed for the primary outcome of movement-evoked pain during single-limb heel raises. RESULTS: All groups demonstrated decreases in movement-evoked pain beyond the minimal clinically important difference from baseline to 8 weeks (2 out of 10 on a numeric pain rating scale). Lower bounds of the 95% CIs for mean differences between groups did not surpass the preestablished noninferiority margin (2 out of 10) for movement-evoked pain in both the telehealth and hybrid groups (telehealth vs in-person: 0.45 [-1.1 to 2.0]; hybrid vs in-person: 0.48 [-1.0 to 1.9]). CONCLUSION: Individuals with chronic AT who completed a tendon-loading program with patient education through a telehealth or hybrid format had no worse outcomes for pain than those who received the same intervention through in-person visits. IMPACT: Physical therapist-directed patient care delivered via telehealth may enhance accessibility to best practice AT rehabilitation, including exercise and education. Use of telehealth technology may also provide an opportunity to prioritize patient preference for physical therapy visit format. LAY SUMMARY: If you are a patient with chronic AT, physical therapist-directed patient care delivered via telehealth may improve your accessibility to best practice AT rehabilitation, including exercise and education. Use of telehealth technology may also prioritize your preferences regarding the format of the physical therapy visit.

The effects of pain science education plus exercise on pain and function in chronic Achilles tendinopathy: a blinded, placebo-controlled, explanatory, randomized trial.

ABSTRACT: Exercise is the standard of care for Achilles tendinopathy (AT), but 20% to 50% of patients continue to have pain following rehabilitation. The addition of pain science education (PSE) to an exercise program may enhance clinical outcomes, yet this has not been examined in patients with AT. Furthermore, little is known about how rehabilitation for AT alters the fear of movement and central nervous system nociceptive processing. Participants with chronic AT (N = 66) were randomized to receive education about AT either from a biopsychosocial (PSE) or from a biomedical (pathoanatomical education [PAE]) perspective. Simultaneously, all participants completed an exercise program over 8 weeks. Linear mixed models indicated that there were no differences between groups in (1) movement-evoked pain with both groups achieving a clinically meaningful reduction (mean change [95% CI], PSE: -3.0 [-3.8 to -2.2], PAE = -3.6 [-4.4 to -2.8]) and (2) self-reported function, with neither group achieving a clinically meaningful improvement (Patient-Reported Outcomes Measurement Information System Physical Function-PSE: 1.8 [0.3-3.4], PAE: 2.5 [0.8-4.2]). After rehabilitation, performance-based function improved (number of heel raises: 5.2 [1.6-8.8]), central nervous system nociceptive processing remained the same (conditioned pain modulation: -11.4% [0.2 to -17.3]), and fear of movement decreased (Tampa Scale of Kinesiophobia, TSK-17: -6.5 [-4.4 to -8.6]). Linear regression models indicated that baseline levels of pain and function along with improvements in self-efficacy and knowledge gain were associated with a greater improvement in pain and function, respectively. Thus, acquiring skills for symptom self-management and the process of learning may be more important than the specific educational approach for short-term clinical outcomes in patients with AT.

The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study Protocol: A Multisite Embedded Pragmatic Trial.

OBJECTIVES: Transcutaneous electrical nerve stimulation (TENS) is a nonpharmacological intervention that provides an electrical current through the skin to produce analgesia. The primary purpose of this study is to examine if the addition of TENS to routine physical therapy improves movement-evoked pain in individuals with fibromyalgia in a physical therapy clinical setting. METHODS: Fibromyalgia TENS in Physical Therapy Study is a phase III embedded pragmatic clinical trial funded through the National Institutes of Health Helping to End Addiction Long-Term Initiative. This trial will utilize a randomized cluster design that includes more than 110 physical therapists in 24 to 30 physical therapy clinics within 6 health care systems and 7 states. Clinics will be randomized to TENS or No-TENS, stratified by health care system and clinic size. The plan is to enroll 600 participants, with all participants completing physical therapy as prescribed by their physical therapist. Participants at TENS clinics will utilize TENS for a minimum of 2-hour per day while at the physical therapy clinic and at home when active. The primary outcome is reduction in movement-evoked pain from baseline to day 60 on an 11-point numeric rating scale when participants sit and stand 5 times (Sit and Stand Test). Secondary outcomes include resting pain and fatigue, pain interference, fibromyalgia disease activity, movement-evoked fatigue, multidimensional assessment of fatigue, rapid assessment of physical activity, patient global impression of change, and common data elements shared across studies supported through the Helping to End Addiction Long-Term Initiative. IMPACT: The findings from this study will provide effectiveness data on TENS for individuals with fibromyalgia for health care policymakers, clinicians, and insurers. Data from this study will also inform future pragmatic trials for nonpharmacological interventions and chronic musculoskeletal pain conditions.

Multi-Site Observational Study to Assess Biomarkers for Susceptibility or Resilience to Chronic Pain: The Acute to Chronic Pain Signatures (A2CPS) Study Protocol.

Chronic pain has become a global health problem contributing to years lived with disability and reduced quality of life. Advances in the clinical management of chronic pain have been limited due to incomplete understanding of the multiple risk factors and molecular mechanisms that contribute to the development of chronic pain. The Acute to Chronic Pain Signatures (A2CPS) Program aims to characterize the predictive nature of biomarkers (brain imaging, high-throughput molecular screening techniques, or "omics," quantitative sensory testing, patient-reported outcome assessments and functional assessments) to identify individuals who will develop chronic pain following surgical intervention. The A2CPS is a multisite observational study investigating biomarkers and collective biosignatures (a combination of several individual biomarkers) that predict susceptibility or resilience to the development of chronic pain following knee arthroplasty and thoracic surgery. This manuscript provides an overview of data collection methods and procedures designed to standardize data collection across multiple clinical sites and institutions. Pain-related biomarkers are evaluated before surgery and up to 3 months after surgery for use as predictors of patient reported outcomes 6 months after surgery. The dataset from this prospective observational study will be available for researchers internal and external to the A2CPS Consortium to advance understanding of the transition from acute to chronic postsurgical pain.

Opioid prescribing patterns for acute pain.

PURPOSE: The current study aimed to identify patients presenting with acute pain who may be at risk for a complicated trajectory, via identifying clusters of early opioid prescribing patterns. METHODS: National Veterans Affairs administrative data were utilized to build a cohort of outpatients with acute pain presentations and no more than minimal opioid use in the prior year. Latent Class Analyses (LCAs) identified clusters of early opioid prescribing patterns. The risk of progression to long-term opioid use was contrasted between LCA clusters using log-binomial regression, adjusting for confounding variables. RESULTS: The 2018 cohort included N = 191,283. Among the 27,890 who received an initial opioid prescription, LCA classes were identified using: first supply day, total days dispensed across 30 days, opioid type, dose and number of prescriptions across the first 30 days. In the three-class model: class 1 indicated an immediate, low-dose and brief supply; class 2 included delayed, low-dose and longer duration prescriptions and class 3 included delayed, high-dose and moderate duration prescriptions. Adjusted relative risk ratios for progression to long-term opioid use in the following year were 3.33 (95% CI: 2.71-4.10) for class 1 (absolute risk 1.1%); 7.76 (95% CI: 6.69-8.99) for class 2 (3.1%) and 6.81 (95% CI: 5.72-8.12) for class 3 (2.4%) compared to patients who did not receive an acute opioid prescription (0.3%). CONCLUSIONS: These clusters of acute opioid prescribing could facilitate the identification of patients who may benefit from enhanced pain care earlier in the pain trajectory and decrease future reliance on long-term opioid therapy.

Longitudinal Changes in the Pelvic Pain Only and Widespread Pain Phenotypes Over One Year in the MAPP-I Urologic Chronic Pelvic Pain Syndrome (UCPPS) Cohort.

OBJECTIVE: To examine how often urologic chronic pelvic pain syndrome (UCPPS) patients progressed from Pelvic Pain Only at baseline to Widespread Pain, or vice versa, during 1-year longitudinal follow-up. METHODS: Men and women with UCPPS enrolled in the MAPP-I Epidemiology and Phenotyping Study completed a self-report body map to indicate their locations of pain every 2 months over 12 months. Patients were categorized at each assessment into one of three pain phenotypes: (1) Pelvic Pain Only, (2) an Intermediate group, (3) Widespread Pain. Only patients who completed 3 or more follow-ups were included in this longitudinal analysis. The primary outcome measure was pain classification at the majority (≥60%) of follow-up assessments. Longitudinal trends of somatic symptom burden were also assessed. RESULTS: Among the 93 UCPPS participants with Pelvic Pain Only at baseline, only 2% (n = 2) showed a Widespread Pain phenotype for the majority of assessments over 12 months. Among the 121 participants who had Widespread Pain at baseline, 6% (n = 7) demonstrated Pelvic Pain Only for the majority of assessments over 12 months. Over half of participants (≥53%) stayed in their baseline phenotypic group. Somatic symptom burden remained stable over 12 months for each of the groups with high intra-class correlation coefficient (0.67 to 0.82). CONCLUSION: It was uncommon for UCPPS patients to progress from Pelvic Pain Only to Widespread Pain, or vice versa, over 12 months. These data suggest that Pelvic Pain Only and Widespread Pain are distinct UCPPS phenotypes that are relatively stable over 12 months of follow up.

Melatonin and risk of mortality in subjects with aneurysmal subarachnoid hemorrhage.

BACKGROUND: Delayed cerebral ischemia (DCI) is a cause of morbidity associated with aneurysmal subarachnoid hemorrhage (aSAH). Neuroinflammation contributes to the development of DCI. Melatonin is a sleep-promoting hormone known to have cerebral anti-inflammatory properties. We hypothesized that synthetic melatonin (or the selective melatonin receptor agonist ramelteon) incidentally prescribed to improve sleep may lower the incidence of DCI among hospitalized aSAH patients. METHODS: Subjects with a Hunt and Hess Grade I-III were identified from a data registry involving all aSAH patients admitted to our hospital between January 2015 and September 1, 2018. A cohort of patients who received either melatonin or ramelteon during their hospitalization was compared to a matched cohort that did not receive these drugs. The primary endpoint was incidence of DCI. Secondary outcomes included modified Rankin score (mRS) at discharge, discharge destination, and mortality at 6 weeks from discharge. The two groups were compared using univariate analysis. P < 0.05 was considered significant. RESULTS: There was no significant difference in the incidence of DCI (15.8% vs. 16.9%, p = 1), discharge mRS (mRS 0-3: 51.3% vs. 45.1%, p = 0.59), discharge disposition (Home: 43.6% vs. 44.4, p = 0.47), or mortality (0% vs. 9.2%; p = 0.074) between the melatonin/ramelteon and non-melatonin groups. CONCLUSION: The use melatonin had no effect on DCI but may improve mortality in aSAH subjects. Prospective studies using a larger cohort are warranted to validate these findings.

AAAPT Diagnostic Criteria for Acute Thoracic Surgery Pain.

Patients undergoing thoracic surgery experience particular challenges for acute pain management. Availability of standardized diagnostic criteria for identification of acute pain after thoracotomy and video assisted thoracic surgery (VATS) would provide a foundation for evidence-based management and facilitate future research. The Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the United States Food and Drug Administration, the American Pain Society (APS), and the American Academy of Pain Medicine (AAPM) formed the ACTTION-APS-AAPM Pain Taxonomy (AAAPT) initiative to address absence of acute pain diagnostic criteria. A multidisciplinary working group of pain experts was invited to develop diagnostic criteria for acute thoracotomy and VATS pain. The working group used available studies and expert opinion to characterize acute pain after thoracotomy and VATS using the 5-dimension taxonomical structure proposed by AAAPT (i.e., core diagnostic criteria, common features, modulating factors, impact/functional consequences, and putative mechanisms). The resulting diagnostic criteria will serve as the starting point for subsequent empirically validated criteria. PERSPECTIVE ITEM: This article characterizes acute pain after thoracotomy and VATS using the 5-dimension taxonomical structure proposed by AAAPT (ie, core diagnostic criteria, common features, modulating factors, impact and/or functional consequences, and putative mechanisms).

AAAPT: Assessment of the Acute Pain Trajectory.

OBJECTIVE: Define and contrast acute pain trajectories vs. the aggregate pain measurements, summarize appropriate linear and nonlinear statistical analyses for pain trajectories at the patient level, and present methods to classify individual pain trajectories. Clinical applications of acute pain trajectories are also discussed. SETTING: In 2016, an expert panel involving the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION), American Pain Society (APS), and American Academy of Pain Medicine (AAPM) established an initiative to create a pain taxonomy, named the ACTTION-APS-AAPM Pain Taxonomy (AAAPT), for the multidimensional classification of acute pain. The AAAPT panel commissioned the present report to provide further details on analysis of the individual acute pain trajectory as an important component of comprehensive pain assessment. METHODS: Linear mixed models and nonlinear models (e.g., regression splines and polynomial models) can be applied to analyze the acute pain trajectory. Alternatively, methods for classifying individual pain trajectories (e.g., using the 50% confidence interval of the random slope approach or using latent class analyses) can be applied in the clinical context to identify different trajectories of resolving pain (e.g., rapid reduction or slow reduction) or persisting pain. Each approach has advantages and disadvantages that may guide selection. Assessment of the acute pain trajectory may guide treatment and tailoring to anticipated symptom recovery. The acute pain trajectory can also serve as a treatment outcome measure, informing further management. CONCLUSIONS: Application of trajectory approaches to acute pain assessments enables more comprehensive measurement of acute pain, which forms the cornerstone of accurate classification and treatment of pain.

Effect of Pain Education and Exercise on Pain and Function in Chronic Achilles Tendinopathy: Protocol for a Double-Blind, Placebo-Controlled Randomized Trial.

BACKGROUND: Achilles tendinopathy (AT) rehabilitation traditionally includes progressive tendon loading exercises. Recent evidence suggests a biopsychosocial approach that incorporates patient education on psychosocial factors and mechanisms of pain can reduce pain and disability in individuals with chronic pain. This is yet to be examined in individuals with AT. OBJECTIVE: This study aims to compare the effects on movement-evoked pain and self-reported function of pain education as part of a biopsychosocial approach with pathoanatomical education for people with AT when combined with a progressive tendon loading exercise program. METHODS: A single-site, randomized, double-blind, placebo-controlled clinical trial will be conducted in a university-based hospital in a laboratory setting and/or by telehealth. A total of 66 participants with chronic (>3 months) midportion or insertional AT will be randomized for the Tendinopathy Education of the Achilles (TEAch) study. All participants will complete progressive Achilles tendon loading exercises over 12 weeks and will be encouraged to continue with self-selected exercises as tolerated. All participants will complete 6-7 one-to-one sessions with a physical therapist to progress exercises in a standardized manner over 8 weeks. During the last 4 weeks of the intervention, participants will be encouraged to maintain their home exercise program. Participants will be randomized to 1 of 2 types of education (pain education or pathoanatomic), in addition to exercise. Pain education will focus on the biological and psychological mechanisms of pain within a biopsychosocial framing of AT. Pathoanatomic education will focus on biological processes within a more traditional biomedical framework of AT. Evaluation sessions will be completed at baseline and 8-week follow-up, and self-reported outcome measures will be completed at the 12-week follow-up. Both groups will complete progressive Achilles loading exercises in 4 phases throughout the 12 weeks and will be encouraged to continue with self-selected exercises as tolerated. Primary outcomes are movement-evoked pain during heel raises and self-reported function (patient-reported outcome measure information system-Physical Function). Secondary outcomes assess central nervous system nociceptive processing, psychological factors, motor function, and feasibility. RESULTS: Institutional review board approval was obtained on April 15, 2019, and study funding began in July 2019. As of March 2020, we randomized 23 out of 66 participants. In September 2020, we screened 267 individuals, consented 68 participants, and randomized 51 participants. We anticipate completing the primary data analysis by March 2022. CONCLUSIONS: The TEAch study will evaluate the utility of pain education for those with AT and the effects of improved patient knowledge on pain, physical function, and clinical outcomes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19111.

A pharmacist intervention for monitoring and treating hypertension using bidirectional texting: PharmText BP.

BACKGROUND: New approaches are needed to better monitor blood pressure (BP) between physician visits, especially for patients in rural areas or for those who lack transportation. We have developed a custom-built bi-directional texting platform for home BP measurements that can then be managed by clinical pharmacists located remotely. The purpose of this study is to evaluate whether the BP texting approach combined with a pharmacist-based intervention improves BP management and to determine if the approach is cost effective. METHODS: This study is a randomized, prospective trial in four primary care offices that serve patients in rural areas. Subjects will receive standardized research BP measurements at baseline, 6 and 12 months. The primary outcome will be differences between the intervention and control group in mean systolic BP at 12 months. Secondary outcomes will include systolic BP at 6 months; diastolic BP at 6 and 12 months, number of medication changes and costs. CONCLUSIONS: This study plans to enroll subjects through 2022, follow-up will be completed in 2023 and results will be available in 2024. This study will provide information on whether a combined approach using texting of home BP values and a pharmacist-based telehealth services can improve BP control.

Opioid use trajectories after thoracic surgery among veterans in the United States.

BACKGROUND: Opioid use has increased to epidemic levels over the past decade within the United States, particularly among vulnerable populations. This retrospective study aimed to evaluate rates of prolonged opioid use in the Veteran population after thoracic surgery and identify specific risk clusters. METHODS: Veterans Administration data on patients who underwent thoracic surgery between January 1, 2006 and September 30, 2015 included preoperative opioid use information for stratification of patients to preoperative chronic opioid use (PCOU; nPCOU  = 16,612) versus patients without preoperative chronic opioid use (WPCOU; nWPCOU  = 2,328). A Poisson regression model and prior literature were used to identify variables for use in a Latent Class Analysis (LCA) model for each stratum. Three-cluster models were selected, and identified as 'low-', 'intermediate-' and 'high-' risk groups. RESULTS: Cluster interpretations included: (a) Low risk: no psychiatric diagnoses, preoperative medication use, or preoperative chronic pain, (b) Intermediate risk: no psychiatric diagnoses, but had preoperative medication use and some preoperative chronic pain and (c) High risk: psychiatric diagnoses, preoperative medication use and preoperative chronic pain. For the PCOU stratum, rates of prolonged opioid use 1 year after surgery were as follows: 46.3%, 61.9% and 66.0%. For the WPCOU stratum, the observed rates were 4.7%, 8.3% and 9.2%. CONCLUSIONS: Prolonged opioid use trajectories obviously differ by PCOU status, as well as preoperative psychosocial diagnoses, medication use and chronic pain. This is a first step in population-level research to curb the rate of prolonged opioid use in Veterans following thoracic surgery. SIGNIFICANCE: This article presents population-level chronic opioid use trajectories after thoracic surgery, using latent class structures. Demographics, preoperative psychological diagnoses, medication usage and chronic pain variables were utilized to identify population-level clusters. The cluster identified as highest risk had preoperative chronic opioid use, psychological diagnoses, other medication prescriptions and chronic pain.