Updating and evaluating a research best practices training course for social and behavioral research professionals.

Introduction: The clinical and translational research workforce involved in social and behavioral research (SBR) needs to keep pace with clinical research guidance and regulations. Updated information and a new module on community and stakeholder engagement were added to an existing SBR training course. This article presents evaluation findings of the updated course for the Social and Behavioral Workforce. Methods and Materials: Participants working across one university were recruited. Course completers were sent an online survey to evaluate the training. Some participants were invited to join in a focus group to discuss the application of the training to their work. We performed descriptive statistics and conducted a qualitative analysis on focus group data. Results: There were 99 participants from diverse backgrounds who completed the survey. Most reported the training was relevant to their work or that of the study teams they worked with. Almost half (46%) indicated they would work differently after participating. Respondents with community or stakeholder engaged research experience vs. those without were more likely to report that the new module was relevant to study teams they worked with (t = 5.61, p = 0.001), and that they would work differently following the training (t = 2.63, p = 0.01). Open-ended survey responses (n = 99) and focus group (n = 12) data showed how participants felt their work would be affected by the training. Conclusion: The updated course was rated highly, particularly by those whose work was related to the new course content. This course provides an up-to-date resource for the training and development for the Social and Behavioral Workforce.

Implementing a mentoring program for clinical research professionals: A novel professional development initiative for university health research staff.

Clinical and translational research relies on a well-trained workforce, but mentorship programs designed expressly for this workforce are lacking. This paper presents the development of a mentoring program for research staff and identifies key programmatic outcomes. Research staff participating in this program were matched with a senior mentor. Focus groups were conducted to identify key program outcomes. Surveys were administered throughout the program period to assess participants' experience, gains in skill, and subsequent careers. Analysis of the resultant qualitative and quantitative data are used to characterize the implementation and impact of the program. A total of 47 mentees and 30 mentors participated in program between 2018 and 2023. A comprehensive logic model of short-, intermediate- and long-term outcomes was developed. Participants reported positive valuations of every programmatic outcome assessed including their program experience, learning and research careers. The pool of available mentors also grew as new mentors were successfully recruited for each cohort. This mentorship program developed and implemented by senior research staff successfully provided junior research staff with professional development support, mentorship, and professional development opportunities. Junior and senior health research staff built mentoring relationships that advanced their clinical and translational research careers.

The Dosing of Mobile-Based Just-in-Time Adaptive Self-Management Prompts for Caregivers: Preliminary Findings From a Pilot Microrandomized Study.

BACKGROUND: Caregivers of people with chronic illnesses often face negative stress-related health outcomes and are unavailable for traditional face-to-face interventions due to the intensity and constraints of their caregiver role. Just-in-time adaptive interventions (JITAIs) have emerged as a design framework that is particularly suited for interventional mobile health studies that deliver in-the-moment prompts that aim to promote healthy behavioral and psychological changes while minimizing user burden and expense. While JITAIs have the potential to improve caregivers' health-related quality of life (HRQOL), their effectiveness for caregivers remains poorly understood. OBJECTIVE: The primary objective of this study is to evaluate the dose-response relationship of a fully automated JITAI-based self-management intervention involving personalized mobile app notifications targeted at decreasing the level of caregiver strain, anxiety, and depression. The secondary objective is to investigate whether the effectiveness of this mobile health intervention was moderated by the caregiver group. We also explored whether the effectiveness of this intervention was moderated by (1) previous HRQOL measures, (2) the number of weeks in the study, (3) step count, and (4) minutes of sleep. METHODS: We examined 36 caregivers from 3 disease groups (10 from spinal cord injury, 11 from Huntington disease, and 25 from allogeneic hematopoietic cell transplantation) in the intervention arm of a larger randomized controlled trial (subjects in the other arm received no prompts from the mobile app) designed to examine the acceptability and feasibility of this intensive type of trial design. A series of multivariate linear models implementing a weighted and centered least squares estimator were used to assess the JITAI efficacy and effect. RESULTS: We found preliminary support for a positive dose-response relationship between the number of administered JITAI messages and JITAI efficacy in improving caregiver strain, anxiety, and depression; while most of these associations did not meet conventional levels of significance, there was a significant association between high-frequency JITAI and caregiver strain. Specifically, administering 5-6 messages per week as opposed to no messages resulted in a significant decrease in the HRQOL score of caregiver strain with an estimate of -6.31 (95% CI -11.76 to -0.12; P=.046). In addition, we found that the caregiver groups and the participants' levels of depression in the previous week moderated JITAI efficacy. CONCLUSIONS: This study provides preliminary evidence to support the effectiveness of the self-management JITAI and offers practical guidance for designing future personalized JITAI strategies for diverse caregiver groups. TRIAL REGISTRATION: ClinicalTrials.gov NCT04556591; https://clinicaltrials.gov/ct2/show/NCT04556591.

The reliability and validity of the TBI-CareQOL system in four diverse caregiver groups.

PURPOSE: Establishing the psychometric reliability and validity of new measures is an ongoing process. More work is needed in to confirm the clinical utility of the TBI-CareQOL measurement development system in both an independent cohort of caregivers of traumatic brain injury (TBI), as well as in additional caregiver groups. METHODS: An independent cohort of caregivers of people with TBI (n = 139), as well as three new diverse caregiver cohorts (n = 19 caregivers of persons with spinal cord injury, n = 21 caregivers for persons with Huntington disease, and n = 30 caregivers for persons with cancer), completed 11 TBI-CareQOL measures (caregiver strain; caregiver-specific anxiety; anxiety; depression; anger; self-efficacy; positive affect and well-being; perceived stress; satisfaction with social roles and activities; fatigue; sleep-related impairment), as well as two additional measures to examine convergent and discriminant validity (PROMIS Global Health; the Caregiver Appraisal Scale). RESULTS: Findings support the internal consistency reliability (all alphas > 0.70 with the vast majority being > 0.80 across the different cohorts) of the TBI-CareQOL measures. All measures were free of ceiling effects, and the vast majority were also free of floor effects. Convergent validity was supported by moderate to high correlations between the TBI-CareQOL and related measures, while discriminant validity was supported by low correlations between the TBI-CareQOL measures and unrelated constructs. CONCLUSION: Findings indicate that the TBI-CareQOL measures have clinical utility in caregivers of people with TBI, as well as in other caregiver groups. As such, these measures should be considered as important outcome measures for clinical trials aiming to improve caregiver outcomes.

An app-based just-in-time-adaptive self-management intervention for care partners: The CareQOL feasibility pilot study.

PURPOSE/OBJECTIVE: The primary objective of this study was to establish the feasibility and acceptability of an intensive data collection protocol that involves the delivery of a personalized just-in-time adaptive intervention (JITAI) in three distinct groups of care partners (care partners of persons with spinal cord injury [SCI], Huntington's disease [HD], or hematopoietic cell transplantation [HCT]). RESEARCH METHOD/DESIGN: Seventy care partners were enrolled in this study (n = 19 SCI; n = 21 HD, n = 30 HCT). This three-month (90 day) randomized control trial involved wearing a Fitbit to track sleep and steps, providing daily reports of health-related quality of life (HRQOL), and completing end of month HRQOL surveys. Care partners in the JITAI group also received personalized pushes (i.e., text-based phone notifications that include brief tips or suggestions for improving self-care). At the end of three-months, care partners in both groups completed a feasibility and acceptability questionnaire. RESULTS: Most (98.6%) care partners completed the study, average compliance was 88% for daily HRQOL surveys, 96% for daily steps, and 85% for daily sleep (from wearing the Fitbit), and all monthly surveys were completed with the exception of one missed 3-month assessment. The acceptability of the protocol was high; ratings exceeded 80% agreement for the different elements of the study. Improvements were seen for the majority of the HRQOL measures. There was no evidence of measurement reactivity. CONCLUSIONS/IMPLICATIONS: Findings provide strong support for the acceptability and feasibility of an intensive data collection protocol that involved the administration of a JITAI. Although this trial was not powered to establish efficacy, findings indicated improvements across a variety of different HRQOL measures (~1/3 of which were statistically significant). (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Improving outcomes for care partners of persons with traumatic brain injury: Protocol for a randomized control trial of a just-in-time-adaptive self-management intervention.

Informal family care partners of persons with traumatic brain injury (TBI) often experience intense stress resulting from their caregiver role. As such, there is a need for low burden, and easy to engage in interventions to improve health-related quality of life (HRQOL) for these care partners. This study is designed to evaluate the effectiveness of a personalized just-in-time adaptive intervention (JITAI) aimed at improving the HRQOL of care partners. Participants are randomized either to a control group, where they wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period (without the personalized feedback), or the JITAI group, where they wear the Fitbit®, provide daily reports of HRQOL and receive personalized self-management pushes for 6 months. 240 participants will be enrolled (n = 120 control group; n = 120 JITAI group). Outcomes are collected at baseline, 1-, 2-, 3-, 4-, 5- & 6-months, as well as 3- and 6-months post intervention. We hypothesize that the care partners who receive the intervention (JITAI group) will show improvements in caregiver strain (primary outcome) and mental health (depression and anxiety) after the 6-month (180 day) home monitoring period. Participant recruitment for this study started in November 2020. Data collection efforts should be completed by spring 2025; results are expected by winter 2025. At the conclusion of this randomized control trial, we will be able to identify care partners at greatest risk for negative physical and mental health outcomes, and will have demonstrated the efficacy of this JITAI intervention to improve HRQOL for these care partners. Trial registration: ClinicalTrial.gov NCT04570930; https://clinicaltrials.gov/ct2/show/NCT04570930.

Impact of a Pilot Structured Mobile Technology Based Lifestyle Intervention for Patients with Nonalcoholic Fatty Liver Disease.

BACKGROUND AND AIMS: Lifestyle modification is the main treatment for nonalcoholic fatty liver disease (NAFLD), but remains challenging to implement. The aim of this pilot was to assess the acceptability and feasibility of a mobile-technology based lifestyle program for NAFLD patients. METHODS: We enrolled adult patients with NAFLD in a 6-month mobile-technology based program where participants received a FitBit with weekly tailored step count goals and nutritional assessments. Anthropometrics, hepatic and metabolic parameters, Fibroscan, physical function and activity, and health-related quality of life measures were obtained at enrollment and month 6. Semi-structured exit interviews were conducted to assess patient's experience with the program. RESULTS: 40 (63%) eligible patients were enrolled. Median age was 52.5 with 53% males, 93% whites, 43% with diabetes and median BMI 33.9. On baseline Fibroscan, 59% had F0-2 fibrosis and 70% had moderate-severe steatosis. 33 patients completed the study. Median percentage of days with valid FitBit data collection was 91. 4 patients increased and maintained, 19 maintained, and 8 increased but subsequently returned to baseline weekly step count. 59% of patients reported Fitbit was easy to use and 66% felt step count feedback motivated them to increase their activity. Roughly 50% of patients had reduction in weight, triglycerides and Fibroscan liver stiffness, and 75% had improvement in controlled attenuation parameter and physical function. CONCLUSIONS: A 6-month mobile-technology based pilot lifestyle intervention was feasible and acceptable to NAFLD patients. The program promoted physical activity and was associated with improvement in clinical parameters in some patients.

An App-Based Just-in-Time Adaptive Self-management Intervention for Care Partners (CareQOL): Protocol for a Pilot Trial.

BACKGROUND: Care partners (ie, informal family caregivers) of individuals with health problems face considerable physical and emotional stress, often with a substantial negative impact on the health-related quality of life (HRQOL) of both care partners and care recipients. Given that these individuals are often overwhelmed by their caregiving responsibilities, low-burden self-management interventions are needed to support care partners to ensure better patient outcomes. OBJECTIVE: The primary objective of this study is to describe an intensive data collection protocol that involves the delivery of a personalized just-in-time adaptive intervention that incorporates passive mobile sensor data feedback (sleep and activity data from a Fitbit [Fitbit LLC]) and real time self-reporting of HRQOL via a study-specific app called CareQOL (University of Michigan) to provide personalized feedback via app alerts. METHODS: Participants from 3 diverse care partner groups will be enrolled (care partners of persons with spinal cord injury, care partners of persons with Huntington disease, and care partners of persons with hematopoietic cell transplantation). Participants will be randomized to either a control group, where they will wear the Fitbit and provide daily reports of HRQOL over a 3-month (ie, 90 days) period (without personalized feedback), or the just-in-time adaptive intervention group, where they will wear the Fitbit, provide daily reports of HRQOL, and receive personalized push notifications for 3 months. At the end of the study, participants will complete a feasibility and acceptability questionnaire, and metrics regarding adherence and attrition will be calculated. RESULTS: This trial opened for recruitment in November 2020. Data collection was completed in June 2021, and the primary results are expected to be published in 2022. CONCLUSIONS: This trial will determine the feasibility and acceptability of an intensive app-based intervention in 3 distinct care partner groups: care partners for persons with a chronic condition that was caused by a traumatic event (ie, spinal cord injury); care partners for persons with a progressive, fatal neurodegenerative disease (ie, Huntington disease); and care partners for persons with episodic cancer conditions that require intense, prolonged inpatient and outpatient treatment (persons with hematopoietic cell transplantation). TRIAL REGISTRATION: ClinicalTrials.gov NCT04556591; https://clinicaltrials.gov/ct2/show/NCT04556591. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/32842.

Effect of Aromatase Inhibitor Therapy on Sleep and Activity Patterns in Early-stage Breast Cancer.

INTRODUCTION: Adherence to aromatase inhibitor (AI) therapy is poor, often because of treatment-emergent side effects, including musculoskeletal symptoms, fatigue, and insomnia. In the present analysis, we examined the sleep patterns and daytime function both objectively using actigraphy and subjectively using validated questionnaires in women initiating AI therapy. PATIENTS AND METHODS: Postmenopausal women with stage 0-III hormone receptor-positive breast cancer who were initiating AI therapy were eligible. The patients wore actigraphy devices for 10 consecutive days and completed questionnaires at baseline before the initiation of AI and after 3 months of AI therapy. Associations between the baseline demographics and symptoms, changes in patient-reported outcomes and actigraphy measures from baseline to 3 months of AI therapy and discontinuation of AI therapy were examined using sign tests, logistic regression models, Spearman's correlation, and linear mixed models. RESULTS: Forty-two patients (86%) completed the baseline assessments and 23 patients (47%) completed both the baseline and the 3-month assessments. Objectively measured daytime function as measured by total daytime activity decreased during the 3 months after starting AI (232,566 activity count vs. 204,205 activity count; P = .023), and the decrease was more evident in women with higher baseline physical function. Reduced daytime activity correlated with increased fatigue (ρ = -0.49; P = .017). CONCLUSION: Daytime function decreased after initiation of AI therapy and correlated moderately with increased fatigue, although no association was identified with changes in pain or sleep quality. Additional studies are required to understand why function is reduced, which could have implications for interventions to improve patient tolerance of, and persistence with, AI therapy.

The Physical Activity Daily (PAD) Trial: The rationale and design of a randomized controlled trial evaluating an internet walking program to improve maximal walking distance among patients with peripheral arterial disease.

BACKGROUND: Despite established guidelines for regular walking as a first line therapy for adults with peripheral arterial disease (PAD), most patients do not walk routinely. This paper presents the design specifications for a randomized clinical trial to examine the effectiveness of an internet-based walking program compared to a telephone intervention, or the combination (internet-based with telephone counseling) for promotion of regular walking in patients with PAD. METHODS: Sedentary adults with documented lower extremity PAD are being recruited from the University of Michigan Health System and the surrounding area. Participants are randomized to one of four arms in a 2×2 factorial design: 1) telephone counseling to promote walking, 2) an internet-based walking program with tailored step-count goals, 3) the combination of telephone counseling with the internet-based walking program, or 4) waitlist control. Participants receive a 4-month intervention phase, after which all participants are followed for an additional 8months to assess long-term adherence to regular walking. Outcomes are assessed at baseline, 4 and 12months. The primary outcome is walking distance assessed through a standardized treadmill protocol. Additional outcomes include change in step-counts measured with a commercial activity tracker, pain-free walking distance, and changes in health-related quality of life from baseline to follow-up. CONCLUSION: Finding effective and feasible programs to promote walking among PAD patients is warranted. This study will add to current evidence regarding use of internet based programs with and without telephone counseling to promote regular walking in this population.

Time Trends and Predictors of Abnormal Postoperative Body Temperature in Infants Transported to the Intensive Care Unit.

Background. Despite increasing adoption of active warming methods over the recent years, little is known about the effectiveness of these interventions on the occurrence of abnormal postoperative temperatures in sick infants. Methods. Preoperative and postoperative temperature readings, patient characteristics, and procedural factors of critically ill infants at a single institution were retrieved retrospectively from June 2006 until May 2014. The primary endpoints were the incidence and trend of postoperative hypothermia and hyperthermia on arrival at the intensive care units. Univariate and adjusted analyses were performed to identify factors independently associated with abnormal postoperative temperatures. Results. 2,350 cases were included. 82% were normothermic postoperatively, while hypothermia and hyperthermia each occurred in 9% of cases. During the study period, hypothermia decreased from 24% to 2% (p < 0.0001) while hyperthermia remained unchanged (13% in 2006, 8% in 2014, p = 0.357). Factors independently associated with hypothermia were higher ASA status (p = 0.02), lack of intraoperative convective warming (p < 0.001) and procedure date before 2010 (p < 0.001). Independent associations for postoperative hyperthermia included lower body weight (p = 0.01) and procedure date before 2010 (p < 0.001). Conclusions. We report an increase in postoperative normothermia rates in critically ill infants from 2006 until 2014. Careful monitoring to avoid overcorrection and hyperthermia is recommended.

Pain, Fatigue, and Physical Activity in Osteoarthritis: The Moderating Effects of Pain- and Fatigue-Related Activity Interference.

OBJECTIVE: To examine how self-reported pain- and fatigue-related activity interference relates to symptoms and physical activity (PA) in daily life among people with knee or hip osteoarthritis. DESIGN: Cross-sectional study with a 7-day repeated-measures assessment period. SETTING: General community. PARTICIPANTS: Participants (N=154; mean age, 65y; 60% women [n=92]) with knee or hip osteoarthritis and pain lasting ≥3 months. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Pain- or fatigue-related activity interference items on the Brief Pain Inventory or Brief Fatigue Inventory, respectively, from baseline survey, momentary pain and fatigue severity (measured 5times/d for 7d), and PA measured with a wrist-worn accelerometer over 7 days. We hypothesized that perception of pain- and fatigue-related activity interference would moderate the association between symptoms (pain or fatigue) and PA. People with higher pain- or fatigue-related activity interference were thought to have stronger negative associations between momentary ratings of pain and fatigue and PA than did those with lower activity interference. RESULTS: Pain-related activity interference moderated the association between momentary pain and PA, but only in the first part of the day. Contrary to expectation, during early to midday (from wake-up time through 3 pm), low pain-related interference was associated with stronger positive associations between pain and PA but high pain-related interference was associated with a small negative association between pain and PA. Fatigue-related activity interference did not moderate the relation between fatigue and activity over the course of a day. CONCLUSIONS: Depending on a person's reported level of pain-related activity interference, associations between pain and PA were different earlier in the day. Only those with high pain-related activity interference had lower levels of PA as pain increased and only in the morning. High pain-related activity interference may be important to address, particularly to maintain PA early in the day despite pain.

Brief time-based activity pacing instruction as a singular behavioral intervention was not effective in participants with symptomatic osteoarthritis.

Osteoarthritis (OA) of the lower extremities is a prevalent cause of disability in which symptoms interfere with mobility and activity participation. Behavioral self-management for OA symptomatology is commonly recommended; but these interventions are underutilized, unstandardized in application, and at times, unavailable in the context of clinical care. For people with chronic pain, rehabilitation professionals may select to apply activity pacing instruction as one behavioral strategy to manage symptoms. Activity pacing is widely used in combination with other pharmacological and behavioral interventions but has not been studied as a singular behavioral intervention for people with OA. The purpose of this study was to evaluate the effectiveness of an occupational therapist-delivered, time-based activity pacing program for treatment of pain, fatigue, and physical function in people with symptomatic knee or hip OA. A 3-arm randomized controlled trial was conducted in which 193 people were randomized into tailored activity pacing, general activity pacing, or usual care arms. Assessments were done at 10 weeks and 6 months after baseline. Using linear mixed models, Western Ontario and McMaster Universities Osteoarthritis Index pain scores changed over time, decreasing the most in the general and usual care groups; only the usual care group had decreased pain over 6 months. The tailored and general activity pacing groups reported higher frequency of pacing behaviors than the usual care group at 10 weeks, but pacing was not sustained at 6 months. This trial does not support the use of time-based pacing as a singular behavioral strategy for people with knee or hip OA.

Characterizing Pain Flares From the Perspective of Individuals With Symptomatic Knee Osteoarthritis.

OBJECTIVE: Although pain in knee osteoarthritis (OA) commonly affects activity engagement, the daily pain experience has not been fully characterized. Specifically, the nature and impact of pain flares is not well understood. This study characterized pain flares as defined by participants with knee OA. Pain flare occurrence and experience were measured over 7 days. METHODS: This was a multiple methods study; qualitative methods were dominant. Data were collected during the baseline portion of a randomized controlled trial. Participants met criteria for knee OA and had moderate to severe pain. They completed questionnaires and a 7-day home monitoring period that captured momentary symptom reports simultaneously with physical activity via accelerometry (n = 45). Participants also provided individual definitions of pain flare that were used throughout the home monitoring period to indicate whether a pain flare occurred. RESULTS: Pain flares were described most often by quality (often sharp), followed by timing (seconds, minutes) and by antecedents and consequences. When asked if their definition of a flare agreed with a supplied definition, 49% of the sample reported only "somewhat," "a little," or "not at all." Using individual definitions, 78% experienced at least 1 daily pain flare over the home monitoring period; 24% had a flare on more than 50% of the monitored days. CONCLUSION: Pain flares were common, fleeting, and often experienced in the context of activity engagement. Participants' views on what constitutes a pain flare differ from commonly accepted definitions. Pain flares are an understudied aspect of the knee OA pain experience and require further characterization.

Effects of sleep restriction and exercise deprivation on somatic symptoms and mood in healthy adults.

OBJECTIVES: Exposure to acute 'stressors' (e.g. infections, pain, trauma) often results in altered sleep habits and reductions in routine activity. In some individuals, these behavioural responses to acute stressors may contribute to the development of chronic somatic symptoms such as widespread pain, fatigue, memory difficulties and mood disturbances, much like those associated with 'functional somatic syndromes' (FSS) such as fibromyalgia or chronic fatigue syndrome. METHODS: Eighty-seven healthy young adults who reported sleeping between 7 and 9 hours nightly and exercising regularly were randomised to one of four groups: exercise cessation, sleep restriction (6 hours nightly), both, or neither. Symptoms of pain, fatigue, cognitive dysfunction and negative mood were measured before and after the 10-day restriction period. RESULTS: Sleep restriction was a potent contributor to the development of somatic symptoms. Exercise cessation was less influential leading only to fatigue. There were no significant interactions between exercise cessation and sleep restriction, except that males were much more likely to develop somatic symptoms when deprived of both sleep and exercise than one or the other. Women were generally much more likely to develop somatic symptoms than men. CONCLUSIONS: This study supports previous research suggesting that both sleep and exercise are critical in 'preventing' somatic symptoms among some individuals. Furthermore, to our knowledge, this is the first time there is data to suggest that women are much more sensitive to decrements in routine sleep and exercise than are men.

Type of activity pacing instruction affects physical activity variability in adults with symptomatic knee or hip osteoarthritis.

BACKGROUND: In a previous pilot study, the effect of 2 types of activity pacing instruction, general versus tailored, on osteoarthritis symptoms was examined and fatigue improved in the tailored group. Because activity pacing involves instruction on physical activity engagement, we undertook this secondary analysis to examine how pacing instruction affected physical activity patterns. METHODS: Thirty-two adults with knee or hip osteoarthritis, stratified by age and gender, received either tailored or general activity pacing instruction. All participants wore an accelerometer for 5 days that measured physical activity and allowed for repeated symptom assessment at baseline and 10-week follow-up. Activity patterns were assessed by examining physical activity variability (standard deviation of 5-day average activity counts per minute), and average activity level (5-day average activity counts per minute). RESULTS: Physical activity variability decreased in the tailored group and increased in the general group. No significant group changes in average activity from baseline to 10-week follow-up were found. CONCLUSION: In this pilot study, type of activity pacing instruction affected objective physical activity patterns in adults with OA. Tailored activity pacing was more effective at reducing high and low activity bouts corresponding to the message of keeping a steady pace to reduce symptoms.

Association between pain, radiographic severity, and centrally-mediated symptoms in women with knee osteoarthritis.

OBJECTIVE: To examine the relationship between pain, radiographic severity, and a common set of co-occurring centrally-mediated symptoms (fatigue, sleep quality, and depression) in women with knee osteoarthritis. METHODS: Participants underwent knee radiographs, and had repeated assessments of pain severity and other centrally-mediated symptoms during a 5-day home monitoring period. To examine associations between pain severity (the average of pain over the home monitoring period), measures of osteoarthritis radiographic severity (Kellgren/Lawrence grade, minimum joint space width), centrally-mediated symptoms, and demographics (age) were used. Symptoms of fatigue, sleep efficiency, and depression were used in a composite measure representing centrally-mediated symptoms. RESULTS: Using a series of linear regression models in which each variable was entered hierarchically (n = 54), the final model showed that 27% of the variance in pain severity was explained by age, radiographic severity, and centrally-mediated symptoms. Centrally-mediated symptoms explained an additional 10% of the variance in pain severity after the other 2 variables were entered. CONCLUSION: Both radiographic severity and centrally-mediated symptoms were independently and significantly associated with pain severity in women with knee osteoarthritis. In addition to more severe radiographic features, women with higher centrally-mediated symptoms had greater pain severity. Treatments for women with symptomatic knee osteoarthritis may be optimized by addressing both peripheral and central sources of pain.

Subgroups of older adults with osteoarthritis based upon differing comorbid symptom presentations and potential underlying pain mechanisms.

INTRODUCTION: Although people with knee and hip osteoarthritis (OA) seek treatment because of pain, many of these individuals have commonly co-occurring symptoms (for example, fatigue, sleep problems, mood disorders). The purpose of this study was to characterize adults with OA by identifying subgroups with the above comorbid symptoms along with illness burden (a composite measure of somatic symptoms) to begin to examine whether subsets may have differing underlying pain mechanisms. METHODS: Community-living older adults with symptomatic knee and hip OA (n = 129) participated (68% with knee OA, 38% with hip OA). Hierarchical agglomerative cluster analysis was used. To determine the relative contribution of each variable in a cluster, multivariate analysis of variance was used. RESULTS: We found three clusters. Cluster 1 (n = 45) had high levels of pain, fatigue, sleep problems, and mood disturbances. Cluster 2 (n = 38) had intermediate degrees of depression and fatigue, but low pain and good sleep. Cluster 3 (n = 42) had the lowest levels of pain, fatigue, and depression, but worse sleep quality than Cluster 2. CONCLUSIONS: In adults with symptomatic OA, three distinct subgroups were identified. Although replication is needed, many individuals with OA had symptoms other than joint pain and some (such as those in Cluster 1) may have relatively stronger central nervous system (CNS) contributions to their symptoms. For such individuals, therapies may need to include centrally-acting components in addition to traditional peripheral approaches.

Activity pacing for osteoarthritis symptom management: study design and methodology of a randomized trial testing a tailored clinical approach using accelerometers for veterans and non-veterans.

BACKGROUND: Osteoarthritis (OA) is a prevalent chronic disease and a leading cause of disability in adults. For people with knee and hip OA, symptoms (e.g., pain and fatigue) can interfere with mobility and physical activity. Whereas symptom management is a cornerstone of treatment for knee and hip OA, limited evidence exists for behavioral interventions delivered by rehabilitation professionals within the context of clinical care that address how symptoms affect participation in daily activities. Activity pacing, a strategy in which people learn to preplan rest breaks to avoid symptom exacerbations, has been effective as part of multi-component interventions, but hasn't been tested as a stand-alone intervention in OA or as a tailored treatment using accelerometers. In a pilot study, we found that participants who underwent a tailored activity pacing intervention had reduced fatigue interference with daily activities. We are now conducting a full-scale trial. METHODS/DESIGN: This paper provides a description of our methods and rationale for a trial that evaluates a tailored activity pacing intervention led by occupational therapists for adults with knee and hip OA. The intervention uses a wrist accelerometer worn during the baseline home monitoring period to glean recent symptom and physical activity patterns and to tailor activity pacing instruction based on how symptoms relate to physical activity. At 10 weeks and 6 months post baseline, we will examine the effectiveness of a tailored activity pacing intervention on fatigue, pain, and physical function compared to general activity pacing and usual care groups. We will also evaluate the effect of tailored activity pacing on physical activity (PA). DISCUSSION: Managing OA symptoms during daily life activity performance can be challenging to people with knee and hip OA, yet few clinical interventions address this issue. The activity pacing intervention tested in this trial is designed to help people modulate their activity levels and reduce symptom flares caused by too much or too little activity. As a result of this trial, we will be able to determine if activity pacing is more effective than usual care, and among the intervention groups, if an individually tailored approach improves fatigue and pain more than a general activity pacing approach. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01192516.

Static versus dynamic splinting for proximal interphalangeal joint pyrocarbon implant arthroplasty: a comparison of current and historical cohorts.

STUDY DESIGN: Nonrandomized mixed current and historical cohort follow-up study. The purpose of the study was to test the effectiveness of static splinting after arthroplasty in patients with osteoarthritis. Dynamic splinting is recommended after proximal interphalangeal joint pyrocarbon implant arthroplasty; however, static splinting may be more feasible to deliver. Nine consecutive patients received static splinting in this study. These patients were compared with those of a historical control group (n = 10) who received dynamic splinting. Function and performance variables were measured preoperatively and 3 months after surgery. All patients underwent surgery by the same hand surgeon, and most of the patients were treated by the same certified hand therapist. Both static and dynamic groups showed improvement on several function and performance measures. Compared with the dynamic group, the static group showed greater improvements in the Michigan. Hand Outcomes Questionnaire subset of work performance (21.00 ± 14.75 vs 3.13 ± 14.13, p < 0.05) and Jebsen-Taylor Test (-11.58 ± 5.44 vs -2.81 ± 3.23, p < 0.03). Patients who received static splinting had similar outcomes to those who received the dynamic splinting. Static splinting requires less therapist training and offers greater patient convenience and is a promising protocol that should be evaluated in a larger study.