Araceli Garcia-Gonzalez

Serum leptin levels in women with systemic lupus erythematosus

Abstract The purpose of this study was to evaluate serum leptin levels in systemic lupus erythematosus (SLE). Forty-one women with SLE were compared with 23 healthy women of similar age and body mass index (BMI). Clinical characteristics and Mexican systemic lupus erythematosus disease activity index (Mex-SLEDAI) score were assessed. Serum leptin levels (ng/dl) were measured by enzyme-linked immunosorbent assay (ELISA). Comparisons of leptin levels were made with the Mann-Whitney U-test. In a multiple regression analysis, those factors that could influence the leptin levels were adjusted. Patients with SLE had higher leptin levels than the control group (SLE median 31 vs control median 15, P=0.023). After adjusting by other variables, the serum leptin levels remained higher in SLE than in controls (P=0.02). Patients with SLE had no association between leptin levels and Mex-SLEDAI score, age, duration of disease, or prednisone doses. Those with SLE had higher leptin levels than controls. Further longitudinal studies are required to evaluate the role of this hormone in the exacerbations of SLE.

Caregiver symptom burden: the risk of caring for an underserved patient with advanced cancer.

The growing diversity of the population of the United States and the high burden of cancer‐related symptoms reflect the need for caregiver research within underserved groups. In this longitudinal study, the authors assessed changes in symptom severity in caregivers and underserved minority patients diagnosed with advanced solid tumors who were being treated at public hospitals.

Electronic Monitoring of Oral Therapies in Ethnically Diverse and Economically Disadvantaged Patients With Rheumatoid Arthritis Consequences of Low Adherence

OBJECTIVE To quantify adherence to oral therapies in ethnically diverse and economically disadvantaged patients with rheumatoid arthritis (RA), using electronic medication monitoring, and to evaluate the clinical consequences of low adherence. METHODS A total of 107 patients with RA enrolled in a 2-year prospective cohort study agreed to have their oral RA drug therapy intake electronically monitored using the Medication Event Monitoring System. Adherence to disease-modifying antirheumatic drugs (DMARDs) and prednisone was determined as the percentage of days (or weeks for methotrexate) on which the patient took the correct dose as prescribed by the physician. Patient outcomes were assessed, including function measured by the modified Health Assessment Questionnaire, disease activity measured by the Disease Activity Score in 28 joints (DAS28), health-related quality of life, and radiographic damage measured using the modified Sharp/van der Heijde scoring method. RESULTS Adherence to the treatment regimen as determined by the percentage of correct doses was 64% for DMARDs and 70% for prednisone. Patients who had better mental health were statistically more likely to be adherent. Only 23 of the patients (21%) had an average adherence to DMARDs ≥80%. These patients showed significantly better mean DAS28 values across 2 years of followup than those who were less adherent (3.28 versus 4.09; P = 0.02). Radiographic scores were also worse in nonadherent patients at baseline and at 12 months. CONCLUSION Only one-fifth of RA patients had an overall adherence to DMARDs of at least 80%. Less than two-thirds of the prescribed DMARD doses were correctly taken. Adherent patients had lower disease activity across the 2 years of followup.

Measuring therapeutic adherence in systemic lupus erythematosus with electronic monitoring.

Objective: We used an electronic monitoring system to quantify adherence to prescribed oral therapies by patients with systemic lupus erythematosus (SLE). Methods: Participants were included from a larger longitudinal study cohort of 110 patients recruited from publicly-funded rheumatology clinics, 78 of whom agreed to have their SLE drug therapy electronically monitored for two years with the Medication Events Monitoring System (MEMS®, AARDEX Group). Adherence was determined as the percentage of days (weeks for methotrexate) the patient took the medication as prescribed by the physician. Collected data included SLEDAI; SLICC damage index for SLE (SDI); medical outcome study social support survey (MOS-SSS); Center for Epidemiologic Studies depression scale (CESD); and quality of life (SF-12). Results: Ninety percent of the cohort was female, 45% were Hispanic, and 49% were African-American. Mean age was 36.3 years, disease duration was 5.9 years, SLEDAI score was 3.2, and SDI score was 0.9. Adherence was 62% for all drugs combined and did not differ significantly for individual medications. Patients with more depression (p < 0.02), and higher number of pills taken daily (p < 0.02) were more likely to be non-adherent. Only one-fourth of the patients had an average adherence of ≥80%; these patients had a better mental component score (SF-12) at 24 months than non-adherent patients (p < 0.01). Conclusions: Electronic monitoring demonstrated that only one-fourth of the patients had an adherence rate ≥80%. Polypharmacy and depression were associated with non-adherence.

Doctor-Patient Interactions in Mexican Patients With Rheumatic Disease

Objective:To evaluate the characteristics of physician-patient communications in Mexican patients with rheumatic diseases. Methods:We prospectively recruited 200 consecutive patients with chronic rheumatic diseases from a rheumatology clinic affiliated with a secondary care hospital in Mexico. All participants completed face-to-face interviews and surveys to determine their perceptions of the medical interaction with the physician at the clinic. Patients were assessed immediately before and after their visits. The Perceptions of Involvement in Care Scale was used to examine 3 factors: the doctors facilitation of involvement, the level of information exchange, and the patients participation in decision making. The Medical Outcomes Study scale was used to evaluate the patient satisfaction with the visit. A Patients’ Trust in Physicians instrument was also administered. Results:No differences in communication, satisfaction, or trust were observed across diseases. Most patients indicated they wanted to play a passive role, with the physicians making the decisions. However, concordance between preferred and actual roles was small (weighted &kgr; = 0.3), suggesting that not all patients played their preferred role. Conclusion:This is the first study to evaluate doctor-patient communication in Mexican patients with rheumatic diseases. In general, patients preferred to play a passive role in their medical interaction. In addition, they often did not attain their preferred communication style when interacting with their physicians. The effect of these findings in subsequent health outcomes is unknown but deserves further investigation.

Automated pain intervention for underserved minority women with breast cancer

Minority patients with breast cancer are at risk for undertreatment of cancer‐related pain. The authors evaluated the feasibility and efficacy of an automated pain intervention for improving pain and symptom management of underserved African American and Latina women with breast cancer.

Niveles de propéptido aminoterminal de procolágeno tipos i y iii y gravedad de la enfermedad pulmonar intersticial en mujeres mexicanas con esclerosis sistémica progresiva

BACKGROUND Interstitial lung disease (ILD) is a frequent complication in progressive systemic sclerosis (SSc), being present in 25% to 90% of cases. OBJECTIVES To evaluate whether serum levels of procollagen typei and iii aminoterminal propeptide (PINP and PIIINP) correlate with severity and patterns of ILD in Mexican women with SSc. METHODS Thirty three SSc patients were assessed for disease characteristics and anti-topoisomerase antibodies (topoi), and also underwent pulmonary function tests and high-resolution computed tomography (HRCT). Nineteen patients had ILD+SSc, and 14 had no lung involvement (no ILD-SSc); data were compared with those from 45 healthy controls. PINP and PIIINP were assessed in all 3 groups. RESULTS Patients with SSc had higher PINP and PIIINP vs controls (P=.001, P<.001, respectively). Compared to no ILD-SSc patients, those with ILD+SSc had longer disease duration in years (P=.005), higher modified Rodnan skin score (P<.001), higher Health Assessment Questionnaire-Disability-Index scores (P<.001), higher topoi U/mL (P<.001), PINP (49.28±28.63 vs. 32.12±18.58μg/L, P=.05), and PIIINP (4.33±1.03 vs. 2.67±1.26μg/L, P<.001) levels. ILD severity based on total HRCT correlated with PINP (r=.388, P=.03) and PIIINP (P=.594, P<.001). On adjusted analysis, ILD severity was associated with disease duration (P=.037), PIIINP (P=.038), and topoi (P=.045). CONCLUSIONS PINP and PIIINP are useful markers for severe ILD+SSc, suggesting they could play a role in the follow-up of this complication in SSc.

Concept domain validation and item generation for the Treatment-Induced Neuropathy Assessment Scale (TNAS)

PurposeTreatment-induced peripheral neuropathy (TIPN) is a difficult problem experienced by patients with cancer that can interfere with their ability to receive optimal therapy. The Treatment-Induced Peripheral Neuropathy Scale (TNAS) is a patient-reported outcome (PRO) measure developed to assess TIPN symptom burden. However, PRO validation is an ongoing process. The aim of this qualitative study was to define the conceptual model, establish content domain validity, and refine items for the TNAS based on patient input.MethodsPatients who received bortezomib, oxaliplatin, or platinum–taxane combination therapy reported their experience of TIPN in single qualitative audiotaped interviews. Themes of the TIPN experience were identified by descriptive analysis of the transcribed interviews.ResultsThree groups of 10 patients each who had received bortezomib, oxaliplatin, or platinum–taxane combination therapy, for a total of 30 patients, reported their experiences. Two themes reported by patients were TIPN sensations and functional interference. Five sensations (numbness, tingling, pain, heat or burning, and coldness) and five functional impacts (using hands, walking, maintaining balance or falling, wearing shoes, and sleeping) were reported by at least 20% of patients and were selected for inclusion in the TNAS v3.0 for additional psychometric testing.ConclusionsThe assessment of TIPN must be convenient, reliable, and practical for patients, who are the most reliable source of information about symptoms. The TNAS, developed with direct patient input, provides an easily administered and conceptually valid method of patient report of TIPN burden for use in research and practice.

A new symptom measure in chronic myeloid leukemia.

e19545 Background: A major barrier to effective symptom management in chronic myeloid leukemia (CML) is inadequate assessment. We aimed to develop a short, easily-understood, valid, and reliable patient-reported outcome measure of CML symptoms for research and practice. METHODS 127 patients with CML completed the 13 symptom severity and 6 interference items of the core M. D. Anderson Symptom Inventory (MDASI) plus 7 CML-specific symptom items (Table), generated from patient and expert input, measured on a 0-10 scale (0 = none, 10 = worst imaginable). 85 patients completed the same items 2 weeks later. Patients also answered a single quality-of-life (QOL) question. Demographic and disease information was collected on all patients. Multivariate analysis examined relationships among items. Psychometric procedures determined reliability and validity of the MDASI-CML. RESULTS Sample characteristics and symptom severity and interference are in the table. All items were retained as clinically significant and nonredundant. The reliability index (Cronbach α) and test-retest reliability of the 20 symptom items were 0.94 and 0.93 respectively and of the 6 interference items were 0.94 and 0.91 respectively. The MDASI-CML discriminated between patients who were employed versus those medically disabled and with good versus poor QOL. Symptom severity explained 87% of the variance in interference, with the core symptoms explaining 83% and the CML-specific symptoms explaining 76%. CONCLUSIONS We have validated an analytic tool, the MDASI-CML, for quantifying CML symptoms. The MDASI-CML is being used to assess side effects in treatment trials and to monitor symptoms in clinical care. [Table: see text] [Table: see text].

Symptom burden in gastrointestinal stromal tumors (GIST).

e16594 Background: The aim of this study is to define the content domain for a patient-reported outcome (PRO) measure of gastrointestinal stromal tumor (GIST) symptom burden. Symptom burden, defined as the combined impact of symptoms and treatment on daily functioning, can be an effective endpoint in clinical trials to establish treatment benefits. METHODS This is Part 1 of a study to develop a PRO GIST symptom-burden measure. Twenty patients with GIST, recruited from a clinic at MD Anderson Cancer Center, described symptoms over their disease courses in single qualitative interviews. After the interviews, patients reported symptoms experienced in the last 24 hours on the core MD Anderson Symptom Inventory (MDASI) to provide context for the analysis. Content analysis was used to identify symptoms and define content domain. RESULTS Mean patient age was 57.9 (standard deviation [SD] = 13.1) years, 55% were male, 40% were employed, 85% were receiving tyrosine kinase inhibitor therapy, 25% had surgery within the last 3 months, 30% had no evidence of disease, 50% had partial response or stable disease, and all had a performance status of <2 (0-5 scale). Content analysis identified 40 symptoms over the disease course, with 18 symptoms reported by > 20% of patients. Pain (75%), fatigue (65%), and peripheral edema (60%) were the 3 most commonly reported symptoms throughout the disease course. On the core MDASI, fatigue followed by drowsiness, disturbed sleep, dry mouth, and distress were the symptoms reported as occurring most often in the last 24 hours. Fatigue had the highest mean severity rating (2.35, SD = 2.43, 0-10 scale) on the core MDASI. The 40 symptoms will be reviewed by an expert panel of care providers and patients for relevance to patients with GIST. The symptoms rated most relevant will be tested for inclusion in the MDASI for GIST. CONCLUSIONS Patients with GIST experience numerous symptoms throughout the disease course. These symptoms can cause significant interference with daily activities. The content domain for a PRO symptom-burden measure of GIST should encompass the severity and activity interference of common symptoms of GIST and its treatments and should be brief enough to allow for frequent administration to detect changes related to treatment benefits.