The association of comorbid conditions with patient-reported outcomes in Veterans with hip and knee osteoarthritis

There is limited understanding of how comorbid health conditions affect osteoarthritis (OA)-related outcomes. This study examined associations of different comorbidity measures with baseline OA-related patient-reported outcomes (PROs) among patients with hip and knee OA. Data were from patients (N=300, 9 % female, mean age = 61.1; SD=9.2) enrolled in a randomized control trial at the Durham Veterans Affairs Medical Center. Separate multivariable regression models, adjusted for demographic and clinical characteristics, examined the association of each comorbidity measure with baseline PROs: pain, physical function, depressive symptoms, fatigue, and insomnia. Comorbidity measures included the Self-Administered Comorbidity Questionnaire (SACQ), conditions reported as activity-limiting (SACQ-AL), and indicators of depression, diabetes, hypertension, and back pain. Mean (SD) numbers of comorbid conditions and activity-limiting conditions were 3.4 (1.8) and 1.6 (1.4), respectively. Comorbidity scores (SACQ overall and SACQ-AL) and individual comorbidity conditions were each associated with worse OA-related PROs adjusting for demographic and clinical factors. Worse SACQ overall and SACQ-AL scores were associated with worse mean scores for pain, depressive symptoms, fatigue, and insomnia (p values <0.01). Additionally, increasing SACQ-AL scores were associated with worse mean scores for function (p<0.01). Depression was associated with worse pain (p=0.03), fatigue, and insomnia (p values <0.01). Diabetes was associated with worse fatigue (p=0.01), depressive symptoms (p=0.02), and insomnia (p=0.03). Back pain was associated with worse pain scores (p=0.02). Results provide evidence that comorbidity burden, particularly activity-limiting conditions, is associated with worse OA-related PROs. Interventions for patients with OA need to address comorbid conditions and their impact on key outcomes

Prevalence of and characteristics associated with insomnia and obstructive sleep apnea among veterans with knee and hip osteoarthritis

Abstract Background Few studies have examined patterns of specific sleep problems among individuals with osteoarthritis (OA). The primary objective of this study was to examine prevalence of symptoms of insomnia and obstructive sleep apnea (OSA) among Veterans with OA. Secondary objectives were to assess proportions of individuals with insomnia and OSA symptoms who may have been undiagnosed and to examine Veterans’ characteristics associated with insomnia and OSA symptoms. Methods Veterans (n = 300) enrolled in a clinical trial completed the Insomnia Severity Index (ISI) and the Berlin Questionnaire (BQ) at baseline; proportions of participants with symptoms consistent with insomnia and OSA were calculated, using standard cut-offs for ISI and BQ. For Veterans with insomnia and OSA symptoms, electronic medical records were searched to identify whether there was a diagnosis code for these conditions. Multivariable linear (ISI) and logistic (BQ) regression models examined associations of the following characteristics with symptoms of insomnia and OSA: age, gender, race, self-reported general health, body mass index (BMI), diagnosis of post-traumatic stress disorder (PTSD), pain severity, depressive symptoms, number of joints with arthritis symptoms and opioid use. Results Symptoms consistent with insomnia and OSA were found in 53 and 66% of this sample, respectively. Among participants screening positive for insomnia and OSA, diagnosis codes for these disorders were present in the electronic medical record for 22 and 51%, respectively. Characteristics associated with insomnia were lower age (β (SE) = − 0.09 (0.04), 95% confidence interval [CI] = − 0.16, − 0.02), having a PTSD diagnosis (β (SE) = 1.68 (0.73), CI = 0.25, 3.11), greater pain severity (β (SE) = 0.36 (0.09), CI = 0.17, 0.55), and greater depressive symptoms (β (SE) = 0.84 (0.07), CI = 0.70, 0.98). Characteristics associated with OSA were higher BMI (odds ratio [OR] = 1.13, CI = 1.06, 1.21), greater depressive symptoms (OR = 1.12, CI = 1.05, 1.20), and opioid use (OR = 0.51, CI = 0.26, 0.99). Conclusions Insomnia and OSA symptoms were very common in Veterans with OA, and a substantial proportion of individuals with symptoms may have been undiagnosed. Characteristics associated with insomnia and OSA symptoms were consistent with prior studies. Trial registration NCT01130740

A Combined Patient and Provider Intervention for Management of Osteoarthritis in Veterans: A Randomized Clinical Trial

Management of osteoarthritis (OA) requires both medical and behavioral strategies, but there is low use of some recommended therapies

Study protocol: Couples Partnering for Lipid Enhancing Strategies (CouPLES) - a randomized controlled trial

Abstract Background Almost 50% of Americans have elevated low-density lipoprotein cholesterol (LDL-C). The behaviors required to lower LDL-C levels may be difficult to adhere to if they are inconsistent with spouses' health practices, and, alternatively, may be enhanced by enlisting support from the spouse. This trial extends previous trials by requiring spouse enrollment, teaching spouses how to provide emotional and instrumental support, allowing patients to decide which component of the intervention they would like to receive, and having patients determine their own goals and action plans. Methods Veteran outpatients with above-goal LDL-C (N = 250) and their spouses are randomized, as a couple, to receive printed education materials only or the materials plus an 11-month, nurse-delivered, telephone-based intervention. The intervention contains four modules: medication adherence, diet, exercise, and patient-physician communication. Patients decide which modules they complete and in which order; modules may be repeated or omitted. Telephone calls are to patients and spouses separately and occur monthly. During each patient telephone call, patients' progress is reviewed, and patients create goals and action plans for the upcoming month. During spouse telephone calls, which occur within one week of patient calls, spouses are informed of patients' goals and action plans and devise strategies to increase emotional and instrumental support. The primary outcome is patients' LDL-C, measured at baseline, 6 months, and 11 months. Linear mixed models will be used to test the primary hypothesis that an 11-month, telephone-based patient-spouse intervention will result in a greater reduction in LDL-C as compared to printed education materials. Various process measures, including social support, self-efficacy, medication adherence, dietary behavior, and exercise, are also assessed to explain any change, or lack thereof, in LDL-C. Discussion Given the social context in which self-management occurs, interventions that teach spouses to provide instrumental and emotional support may help patients initiate and adhere to behaviors that lower their LDL-C levels. Moreover, allowing patients to retain autonomy by deciding which behaviors they would like to change and how may improve adherence and clinical outcomes. Trial Registration The ClinicalTrials.gov registration number is NCT00321789

Clinic variation in recruitment metrics, patient characteristics and treatment use in a randomized clinical trial of osteoarthritis management

Abstract Background The Patient and PRovider Interventions for Managing Osteoarthritis (OA) in Primary Care (PRIMO) study is one of the first health services trials targeting OA in a multi-site, primary care network. This multi-site approach is important for assessing generalizability of the interventions. These analyses describe heterogeneity in clinic and patient characteristics, as well as recruitment metrics, across PRIMO study clinics. Methods Baseline data were obtained from the PRIMO study, which enrolled n = 537 patients from ten Duke Primary Care practices. The following items were examined across clinics with descriptive statistics: (1) Practice Characteristics, including primary care specialty, numbers and specialties of providers, numbers of patients age 55+, urban/rural location and county poverty level; (2) Recruitment Metrics, including rates of eligibility, refusal and randomization; (3) Participants’ Characteristics, including demographic and clinical data (general and OA-related); and (4) Participants’ Self-Reported OA Treatment Use, including pharmacological and non-pharmacological therapies. Intraclass correlation coefficients (ICCs) were computed for participant characteristics and OA treatment use to describe between-clinic variation. Results Study clinics varied considerably across all measures, with notable differences in numbers of patients age 55+ (1,507-5,400), urban/rural location (ranging from “rural” to “small city”), and proportion of county households below poverty level (12%-26%). Among all medical records reviewed, 19% of patients were initially eligible (10%-31% across clinics), and among these, 17% were randomized into the study (13%-21% across clinics). There was considerable between-clinic variation, as measured by the ICC (>0.01), for the following patient characteristics and OA treatment use variables: age (means: 60.4-66.1 years), gender (66%-88% female), race (16%-61% non-white), low income status (5%-27%), presence of hip OA (26%-68%), presence both knee and hip OA (23%-61%), physical therapy for knee OA (24%-61%) and hip OA (0%-71%), and use of knee brace with metal supports (0%-18%). Conclusions Although PRIMO study sites were part of one primary care practice network in one health care system, clinic and patient characteristics varied considerably, as did OA treatment use. This heterogeneity illustrates the importance of including multiple, diverse sites in trials for knee and hip OA, to enhance the generalizability and evaluate potential for real-world implementation. Trial registration Clinical Trial Registration Number: NCT 0143510

A feasibility study to develop and test a Spanish patient and provider intervention for managing osteoarthritis in Hispanic/Latino adults (PRIMO-Latino)

Abstract Background Arthritis affects approximately 50 million adults in the USA. Hispanics/Latinos have a higher prevalence of arthritis-attributed activity limitations primarily related to osteoarthritis (OA). Hispanic/Latinos are less likely to receive hip replacement independent of health care access, and they are less likely to receive knee replacement. There have been few interventions to improve OA treatment among the Hispanic/Latino population in the USA. In our study, we aimed to develop and test a telephone delivered culturally appropriate Spanish behavioral intervention for the management of OA in Hispanic/Latino adults. Methods We conducted a feasibility study in an academic health center and local community in Durham, North Carolina. We enrolled self-identified Spanish speaking overweight/obese adults (≥ 18) with OA of the knee and/or hip under the care of a primary health care provider. The 12-month patient intervention focused on physical activity, weight management, and cognitive behavioral pain management skills. The patient intervention was delivered via telephone with calls scheduled twice per month for the first 6 months, then monthly for the last 6 months (18 sessions). The one-time provider intervention included delivery of patient-specific OA treatment recommendations, based on patients’ baseline data and published guidelines. The primary measures were metrics of feasibility, including recruitment and intervention delivery. We also assessed pain, stiffness, and function using the Spanish-Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Results A total of 1879 participants were identified for potential enrollment. Of those, 1864 did not meet inclusion criteria, were not able to be reached or refused. Fifteen participants enrolled in the intervention. The mean number of phone calls completed was 14.7. Eighty percent completed more than 16 calls. The mean WOMAC baseline score (SD) was 39 (20); mean improvement in WOMAC scores between baseline and 12 months, among 11 participants who completed the study, was − 13.27 [95% CI, − 25.09 to − 1.46] points. Conclusion Recruitment of Hispanics/Latinos, continues to be a major challenge. A Spanish-based telephone delivering lifestyle intervention for OA management in Hispanic/Latino adults is feasible to deliver and may lead to improved OA symptoms. Future research is needed to further test the feasibility and effectiveness of this type of intervention in this segment of the population. Trial registration NCT0178241

Predictors of variation in serum IGF1 and IGFBP3 levels in healthy African American and white men.

Background—Individual variation in circulating insulin-like growth factor-I (IGF1) and its major binding protein, insulin-like growth factor binding protein-3 (IGFBP3) have been etiologically linked to several chronic diseases, including some cancers. Factors associated with variation in circulating levels of these peptide hormones remain unclear. Methods—Multiple linear regression models were used to determine the extent to which sociodemographic characteristics, lifestyle factors, personal and family history of chronic disease, and common genetic variants, the (CA)n repeat polymorphism in the IGF1 promoter and the IGFBP3 -202 A/C polymorphism (rs2854744) predict variation in IGF1 or IGFBP3 serum levels in 33 otherwise healthy African American and 37 white males recruited from Durham Veterans Administration Medical Center. Results—Predictors of serum IGF1, IGFBP3 and the IGF1:IGFBP3 molar ratio varied by race. In African Americans, 17% and 28% of the variation in serum IGF1 and the IGF1:IGFBP3 molar ratio, respectively, was explained by cigarette smoking and carrying the IGF1 (CA)19 repeat allele, respectively. Not carrying at least one IGF1 (CA)19 repeat allele and a high BMI explained 8% and 14%, respectively, of the variation IGFBP3 levels. These factors did not predict variation of these peptides in whites. Conclusion—If successfully replicated in larger studies, these findings add to recent evidence suggesting known genetic and lifestyle chronic disease risk factors influence IGF1 and IGFBP3 circulating levels differently in African Americans and whites

Clinical Associations of an Updated Medication Effect Score for Measuring Diabetes Treatment Intensity

OBJECTIVES: The medication effect score reflects overall intensity of a diabetes regimen by consolidating dosage and potency of agents used. Little is understood regarding how medication intensity relates to clinical factors. We updated the medication effect score to account for newer agents and explored associations between medication effect score and patient-level clinical factors. METHODS: Cross-sectional analysis of baseline data from a randomized controlled trial involving 263 Veterans with type 2 diabetes and hemoglobin AIc levels ≥8.0% (≥7.5% if under age 50). Medication effect score was calculated for all patients at baseline, alongside additional measures including demographics, comorbid illnesses, hemoglobin AIc, and self-reported psychosocial factors. We used multivariable regression to explore associations between baseline medication effect score and patient-level clinical factors. RESULTS: Our sample had a mean age of 60.7 (SD = 8.2) years, was 89.4% male, and 57.4% non-White. Older age and younger onset of diabetes were associated with a higher medication effect score, as was higher body mass index. Higher medication effect score was significantly associated with medication nonadherence, although not with hemoglobin AIc, self-reported hypoglycemia, diabetes-related distress, or depression. DISCUSSION: We observed several expected associations between an updated medication effect score and patient-level clinical factors. These associations support the medication effect score as an appropriate measure of diabetes regimen intensity in clinical and research contexts