Cynthia J. Coffman

Ovarian Preservation by GnRH Agonists during Chemotherapy: A Meta-Analysis

PURPOSE Treatment with cyclophosphamide (CYC) confers up to a 40% risk of ovarian failure in women of reproductive age. The use of GnRH agonists (GnRHa) to preserve ovarian function has been investigated in several small studies. We performed a systematic review of studies examining whether a GnRHa administered during chemotherapy is protective of ovarian function and fertility. METHODS We searched the English-language literature (1966-April 2007) using MEDLINE and meeting abstracts and included studies that reported an association between GnRHa and ovarian preservation in women receiving chemotherapy. Studies without a control group were excluded. Ovarian preservation was defined as the resumption of menstrual cycles and a premenopausal follicle-stimulating hormone (FSH) after chemotherapy. Fertility was determined by a womans ability to become pregnant. We estimated the summary relative risk (RR) and associated 95% confidence intervals (95% CI) using a random-effects model. RESULTS Nine studies included 366 women. Three studies included women with autoimmune disease receiving CYC; six included women with hematologic malignancy receiving combination chemotherapy. In total, 178 women were treated with GnRHa during chemotherapy, 93% of whom maintained ovarian function. Of the 188 women not treated with GnRHa, 48% maintained ovarian function. The use of a GnRHa during chemotherapy was associated with a 68% increase in the rate of preserved ovarian function compared with women not receiving a GnRHa (summary RR = 1.68, 95% CI 1.34-2.1). Among the GnRHa-treated women, 22% achieved pregnancy following treatment compared with 14% of women without GnRHa therapy (summary RR = 1.65, CI 1.03-2.6). CONCLUSIONS Based on the available studies, GnRHa appear to improve ovarian function and the ability to achieve pregnancy following chemotherapy. Several randomized trials are underway to define the role and mechanism of GnRHa in ovarian function preservation. In the meantime, premenopausal women facing chemotherapy should be counseled about ovarian preservation options, including the use of GnRHa therapy.

Medical Clinics Versus Usual Care for Patients With Both Diabetes and Hypertension: A Randomized Trial

BACKGROUND Group medical clinics (GMCs) are widely used in the management of diabetes and hypertension, but data on their effectiveness are limited. OBJECTIVE To test the effectiveness of GMCs in the management of comorbid diabetes and hypertension. DESIGN Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00286741) SETTING 2 Veterans Affairs Medical Centers in North Carolina and Virginia. PATIENTS 239 patients with poorly controlled diabetes (hemoglobin A(1c) [HbA(1c)] level > or =7.5%) and hypertension (systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg). INTERVENTION Patients were randomly assigned within each center to either attend a GMC or receive usual care. Clinics comprised 7 to 8 patients and a care team that consisted of a primary care general internist, a pharmacist, and a nurse or other certified diabetes educator. Each session included structured group interactions moderated by the educator. The pharmacist and physician adjusted medication to manage each patients HbA(1c) level and blood pressure. MEASUREMENTS Hemoglobin A(1c) level and systolic blood pressure, measured by blinded research personnel at baseline, study midpoint (median, 6.8 months), and study completion (median follow-up, 12.8 months). Linear mixed models, adjusted for clustering within GMCs, were used to compare HbA(1c) levels and systolic blood pressure between the intervention and control groups. RESULTS Mean baseline systolic blood pressure and HbA(1c) level were 152.9 mm Hg (SD, 14.2) and 9.2% (SD, 1.4), respectively. At the end of the study, mean systolic blood pressure improved by 13.7 mm Hg in the GMC group and 6.4 mm Hg in the usual care group (P = 0.011 by linear mixed model), whereas mean HbA(1c) level improved by 0.8% in the GMC group and 0.5% in the usual care group (P = 0.159). LIMITATION Measurements of effectiveness may have been limited by concomitant improvements in the usual care group that were due to co-intervention. CONCLUSION Group medical clinics are a potent strategy for improving blood pressure but not HbA(1c) level in diabetic patients. PRIMARY FUNDING SOURCE U.S. Department of Veterans Affairs Health Services Research and Development Service.

Barriers to Full Colon Evaluation for a Positive Fecal Occult Blood Test

Background: Failure to appropriately evaluate a positive cancer screening test may negate the value of doing that test. The primary aim of this study was to explore the factors associated with undergoing a full colon evaluation for a positive fecal occult blood test (FOBT) in a single Veterans Affairs center. Methods: Medical records of consecutive patients ages ≥50 years, who had a positive screening FOBT from March 2000 to February 2001, were abstracted. Patient demographics, dates of ordering and doing follow-up test(s), and adherence with scheduled procedures were collected. The primary outcome, full colon evaluation, was defined as having a colonoscopy or double-contrast barium enema plus flexible sigmoidoscopy completed within 12 months. Results: The sample (N = 538) was 98% men (58% Caucasian, 29% African-American, and 13% unknown race). Approximately 77% of the patients were referred to gastroenterology. Ultimately, only 44% underwent full colon evaluation within 12 months. Approximately 20% of the patients failed to attend a scheduled procedure. Referral to gastroenterology and adherence to follow-up appointments were associated with full colon evaluation. There was no association between African-American versus Caucasian race and full colon evaluation. Conclusions: Less than half of the patients with a positive FOBT had a full colon evaluation within 12 months. Multiple failures were identified, including lack of referral for further testing and patient nonadherence. Although the overall performance in evaluating a positive colorectal cancer screening test was poor, no racial disparity was observed. (Cancer Epidemiol Biomarkers Prev 2006;15(6):1232–5)

Physician Empathy and Listening: Associations with Patient Satisfaction and Autonomy

Purpose: Motivational Interviewing (MI) is used to help patients change their behaviors. We sought to determine if physician use of specific MI techniques increases patient satisfaction with the physician and perceived autonomy. Methods: We audio-recorded preventive and chronic care encounters between 40 primary care physicians and 320 of their overweight or obese patients. We coded use of MI techniques (eg, empathy, reflective listening). We assessed patient satisfaction and how much the patient felt the physician supported him or her to change. Generalized estimating equation models with logit links were used to examine associations between MI techniques and patient perceived autonomy and satisfaction. Results: Patients whose physicians were rated as more empathic had higher rates of high satisfaction than patients whose physicians were less empathic (29% vs 11%; P = .004). Patients whose physicians made any reflective statements had higher rates of high autonomy support than those whose physicians did not (46% vs 30%; P = .006). Conclusions: When physicians used reflective statements, patients were more likely to perceive high autonomy support. When physicians were empathic, patients were more likely to report high satisfaction with the physician. These results suggest that physician training in MI techniques could potentially improve patient perceptions and outcomes.

Amyotrophic Lateral Sclerosis among 1991 Gulf War Veterans: Evidence for a Time-Limited Outbreak

Background: In follow-up to recent reports of an elevated risk of amyotrophic lateral sclerosis (ALS) among 1991 Gulf War veterans, we analyzed the distribution of disease onset times to determine whether the excess risk was time limited. Methods: This secondary analysis used data from a population-based series of ALS cases identified between 1991 and 2001 among the 2.5 million military personnel who were on active duty during the 1991 Gulf War. Annual standardized incidence ratios (SIR) were calculated for all cases and for those with disease onset before age 45 years. Results: Forty-eight of 124 cases occurred among those deployed to the Persian Gulf region during the war. The annual SIR for deployed military personnel did not demonstrate a monotonically increasing trend for either all cases (χ2 = 0.11, d.f. = 1, p = 0.74) or for cases under 45 years of age at onset (χ2 = 2.41, d.f. = 1, p = 0.12). The highest risk was observed in 1996, declining thereafter. Among military personnel who were not deployed to the Gulf region, the level of risk remained fairly constant during the 11-year period. Conclusions: The excess risk of ALS among 1991 Gulf War veterans was limited to the decade following the war.

Telephone-based self-management of osteoarthritis: A randomized trial.

BACKGROUND Osteoarthritis is a leading cause of pain and disability, and self-management behaviors for osteoarthritis are underutilized. OBJECTIVE To examine the effectiveness of a telephone-based self-management intervention for hip or knee osteoarthritis in a primary care setting. DESIGN Randomized clinical trial with equal assignment to osteoarthritis self-management, health education (attention control), and usual care control groups. (ClinicalTrials.gov registration number: NCT00288912) SETTING Primary care clinics in a Veterans Affairs Medical Center. PATIENTS 515 patients with symptomatic hip or knee osteoarthritis. INTERVENTION The osteoarthritis self-management intervention involved educational materials and 12 monthly telephone calls to support individualized goals and action plans. The health education intervention involved nonosteoarthritis educational materials and 12 monthly telephone calls related to general health screening topics. MEASUREMENTS The primary outcome was score on the Arthritis Impact Measurement Scales-2 pain subscale (range, 0 to 10). Pain was also assessed with a 10-cm visual analog scale. Measurements were collected at baseline and 12 months. RESULTS 461 participants (90%) completed the 12-month assessment. The mean Arthritis Impact Measurement Scales-2 pain score in the osteoarthritis self-management group was 0.4 point lower (95% CI, -0.8 to 0.1 point; P = 0.105) than in the usual care group and 0.6 point lower (CI, -1.0 to -0.2 point; P = 0.007) than in the health education group at 12 months. The mean visual analog scale pain score in the osteoarthritis self-management group was 1.1 points lower (CI, -1.6 to -0.6 point; P < 0.001) than in the usual care group and 1.0 point lower (CI, -1.5 to -0.5 point; P < 0.001) than in the health education group. Health care use did not differ across the groups. LIMITATION The study was conducted at 1 Veterans Affairs Medical Center, and the sample consisted primarily of men. CONCLUSION A telephone-based osteoarthritis self-management program produced moderate improvements in pain, particularly compared with a health education control group. PRIMARY FUNDING SOURCE U.S. Department of Veterans Affairs Health Services Research and Development Service.

Racial differences in osteoarthritis pain and function: potential explanatory factors

OBJECTIVE This study examined factors underlying racial differences in pain and function among patients with hip and/or knee osteoarthritis (OA). METHODS Participants were n=491 African Americans and Caucasians enrolled in a clinical trial of telephone-based OA self-management. Arthritis Impact Measurement Scales-2 (AIMS2) pain and function subscales were obtained at baseline. Potential explanatory variables included arthritis self-efficacy, AIMS2 affect subscale, problem- and emotion-focused pain coping, demographic characteristics, body mass index, self-reported health, joint(s) with OA, symptom duration, pain medication use, current exercise, and AIMS2 pain subscale (in models of function). Variables associated with both race and pain or function, and which reduced the association of race with pain or function by >or=10%, were included in final multivariable models. RESULTS In simple linear regression models, African Americans had worse scores than Caucasians on AIMS2 pain (B=0.65, P=0.001) and function (B=0.59, P<0.001) subscales. In multivariable models race was no longer associated with pain (B=0.03, P=0.874) or function (B=0.07, P=0.509), indicating these associations were accounted for by other covariates. Variables associated with worse AIMS2 pain and function were: worse AIMS2 affect scores, greater emotion-focused coping, lower arthritis self-efficacy, and fair or poor self-reported health. AIMS2 pain scores were also significantly associated with AIMS2 function. CONCLUSION Factors explaining racial differences in pain and function were largely psychological, including arthritis self-efficacy, affect, and use of emotion-focused coping. Self-management and psychological interventions can influence these factors, and greater dissemination among African Americans may be a key step toward reducing racial disparities in pain and function.

Estimating the Occurrence of Amyotrophic Lateral Sclerosis among Gulf War (1990–1991) Veterans Using Capture-Recapture Methods

Objective: Using data from a recent report that indicated a 2-fold higher risk of amyotrophic lateral sclerosis (ALS) among veterans of the 1991 Gulf War, we applied capture-recapture methodology to estimate possible under-ascertainment of ALS cases among deployed and non-deployed military personnel who were on active duty during that war. Study Design and Setting: One of the most serious concerns facing field epidemiological investigations is that of case ascertainment bias, particularly when it is differential among the study groups. Capture-recapture methods, however, have promise as an approach to assessing the impact of case ascertainment bias in such studies. To overcome potential limitations of any one approach, three different estimation methods were used: log-linear models, sample coverage, and ecological models, to obtain a comprehensive view of under-ascertainment bias in these populations. Results: All three approaches indicated differential undercount of ALS cases with modest under-ascertainment likely to have occurred among non-deployed military personnel, but little under-ascertainment among the deployed. After correcting the rates for under-ascertainment, the age-adjusted risk of ALS remained elevated among military personnel who had been deployed to S.W. Asia during the 1991 Gulf War, confirming the earlier report. Conclusions: Capture-recapture methods are a useful approach to assessing the magnitude of case ascertainment bias in epidemiological studies from which ascertainment-adjusted estimates of rates and relative risks can be calculated.

Ascertainment of Colonoscopy Indication Using Administrative Data

BackgroundAdministrative procedure code data can estimate colonoscopy utilization; however, determining colonoscopy indication is more difficult as procedure codes do not inherently reflect the purpose (screening, surveillance, diagnosis) of the colonoscopy.AimTo improve the reported sensitivity (70%) and specificity (72%) of a published algorithm for identifying screening colonoscopies using Veterans Health Administration (VHA) administrative data.MethodsWe validated three algorithms for determining colonoscopy indication using medical records as the gold standard in a national sample of 650 patients. Algorithms used International Classification of Diseases, 9th Revision (ICD-9) and Current Procedural Terminology (CPT) codes. Medical records were manually abstracted using standardized protocols.ResultsThe best algorithm had 83% sensitivity and 76% specificity for screening indication. Over 99% of colonoscopy CPT codes corresponded to a colonoscopy in the medical record.ConclusionsVHA procedure codes are very accurate for colonoscopy utilization; however, algorithms to ascertain indication have only moderate accuracy.

The National Registry of Veterans with Amyotrophic Lateral Sclerosis

Background: The Department of Veterans Affairs (VA) Cooperative Studies Program has established a National Registry of Veterans with Amyotrophic Lateral Sclerosis (ALS). This article describes the objectives, methods, and sample involved in the registry. Methods: United States military veterans with ALS were identified through national VA electronic medical record databases and nationwide publicity efforts for an enrollment period of 4 1/2 years. Diagnoses were confirmed by medical record reviews. Registrants were asked to participate in a DNA bank. Follow-up telephone interviews are conducted every 6 months to track participants’ health status. Results: As of September 30, 2007, 2,400 veterans had consented to participate in the registry, 2,068 were included after medical record review, 995 were still living and actively participating, and 1,573 consented to participate in the DNA bank. 979 participants had been enrolled in the registry for at least 1 year, 497 for at least 2 years, and 205 for at least 3 years. Fourteen studies have been approved to use registry data for epidemiological, observational, and interventional protocols. Conclusion: This registry has proven to be a successful model for identifying large numbers of patients with a relatively rare disease and enrolling them into multiple studies, including genetic protocols.