Elinor Schoenfeld

Patterns of adherence to diabetes vision care guidelines: Baseline findings from the Diabetic Retinopathy Awareness Program☆

OBJECTIVES (1) To describe baseline patterns of adherence to American Diabetes Association and American Academy of Ophthalmology vision care guidelines for diabetes in the Diabetic Retinopathy Awareness Program, and (2) to evaluate factors associated with nonadherence. This paper describes the baseline characteristics of a population enrolled in a prospective, randomized clinical trial. DESIGN Cross-sectional study. PARTICIPANTS Between October 1993 and May 1994, the study identified 2308 persons with diabetes, 18 years of age or older, who were residents of Suffolk County, New York, via a multimedia community-wide recruitment campaign. INTERVENTION AND METHODS Eligibility for the trial was determined during a 20-minute phone interview, which included questions about vision care practices; diabetes management; and knowledge, attitudes, and beliefs about diabetes, vision, and diabetic retinopathy. This paper describes these patient characteristics at baseline. Eligible patients would be randomized subsequently to a 2-year diabetes educational intervention arm, which included mailed packets and newsletters focused on vision care, or to a control nonintervention arm. MAIN OUTCOME MEASURE Nonadherence to guidelines at baseline was defined as the absence of a dilated eye examination during the year before recruitment into the study. RESULTS Of the 2308 persons interviewed, 813 (35%) did not follow the vision care guidelines; two thirds of this group reported no eye examination in the year before the interview, and one third had an undilated examination. Ophthalmologists performed 49% of the examinations in the nonadherent group, versus 86% in the adherent group. In logistic regression analyses, factors related to nonadherence were: younger age (odds ratio [OR] = 0.97), type 2 diabetes with or without insulin use (OR = 1.62 and 1.99, respectively), shorter diabetes duration (OR = 0.97), last eye examination performed by an optometrist (OR = 5.32) or other nonophthalmologist (OR = 4.29), less practical knowledge about diabetes (OR = 1.57), and no prior formal diabetes education (OR = 1.30). CONCLUSIONS Within this population, more than one third of participants had not been following vision care guidelines. Nonadherence was linked to several potentially modifiable factors; changes in these factors could enhance the early detection of diabetic retinopathy.

Antioxidant vitamins and nuclear opacities: the longitudinal study of cataract.

OBJECTIVE The association of antioxidant nutrients and risk of nuclear opacification was evaluated in the Longitudinal Study of Cataract. DESIGN Nutritional data were collected at baseline on the 764 participants, which included assessment of dietary intake, use of vitamin supplements, and plasma levels of vitamin E. Ophthalmologic and other data were collected at baseline and at yearly follow-up visits, including lens photographs, which were graded using the Lens Opacities Classification System III protocol. MAIN OUTCOME MEASURES Analyses examined whether the nutritional factors at baseline were related to increases in nuclear opacification at follow-up. The MULCOX2 approach, an extension of the Cox regression model, was used. Results are presented as relative risks (RRs) and 95% confidence intervals. INTERVENTION Intervention was not applicable. RESULTS The risk of nuclear opacification at follow-up was decreased in regular users of multivitamin supplements (RR = 0.69; 0.48-0.99), vitamin E supplements (RR = 0.43; 0.19-0.99), and in persons with higher plasma levels of vitamin E (RR = 0.58; 0.36-0.94). CONCLUSIONS In regular users of multivitamin supplements, the risk of nuclear opacification was reduced by one third; in regular users of vitamin E supplements and persons with higher plasma levels of vitamin E, the risk was reduced by approximately half. These results are similar to those obtained in our earlier case-control study. Because these data are based on observational studies only, the results are suggestive but inconclusive. The possible effect of nutritional supplements on the lens requires confirmation by ongoing clinical trials.

The effect of nonsurgical periodontal therapy on hemoglobin a1c levels in persons with type 2 diabetes and chronic periodontitis a randomized clinical trial

IMPORTANCE Chronic periodontitis, a destructive inflammatory disorder of the supporting structures of the teeth, is prevalent in patients with diabetes. Limited evidence suggests that periodontal therapy may improve glycemic control. OBJECTIVE To determine if nonsurgical periodontal treatment reduces levels of glycated hemoglobin (HbA1c) in persons with type 2 diabetes and moderate to advanced chronic periodontitis. DESIGN, SETTING, AND PARTICIPANTS The Diabetes and Periodontal Therapy Trial (DPTT), a 6-month, single-masked, multicenter, randomized clinical trial. Participants had type 2 diabetes, were taking stable doses of medications, had HbA1c levels between 7% and less than 9%, and untreated chronic periodontitis. Five hundred fourteen participants were enrolled between November 2009 and March 2012 from diabetes and dental clinics and communities affiliated with 5 academic medical centers. INTERVENTIONS The treatment group (n = 257) received scaling and root planing plus chlorhexidine oral rinse at baseline and supportive periodontal therapy at 3 and 6 months. The control group (n = 257) received no treatment for 6 months. MAIN OUTCOMES AND MEASURES Difference in change in HbA1c level from baseline between groups at 6 months. Secondary outcomes included changes in probing pocket depths, clinical attachment loss, bleeding on probing, gingival index, fasting glucose level, and Homeostasis Model Assessment (HOMA2) score. RESULTS Enrollment was stopped early because of futility. At 6 months, mean HbA1c levels in the periodontal therapy group increased 0.17% (SD, 1.0), compared with 0.11% (SD, 1.0) in the control group, with no significant difference between groups based on a linear regression model adjusting for clinical site (mean difference, -0.05% [95% CI, -0.23% to 0.12%]; P = .55). Periodontal measures improved in the treatment group compared with the control group at 6 months, with adjusted between-group differences of 0.28 mm (95% CI, 0.18 to 0.37) for probing depth, 0.25 mm (95% CI, 0.14 to 0.36) for clinical attachment loss, 13.1% (95% CI, 8.1% to 18.1%) for bleeding on probing, and 0.27 (95% CI, 0.17 to 0.37) for gingival index (P < .001 for all). CONCLUSIONS AND RELEVANCE Nonsurgical periodontal therapy did not improve glycemic control in patients with type 2 diabetes and moderate to advanced chronic periodontitis. These findings do not support the use of nonsurgical periodontal treatment in patients with diabetes for the purpose of lowering levels of HbA1c. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00997178.

Breast Cancer and Electromagnetic Fields—A Review

PURPOSE Several statements have been issued to the effect that no consistent, significant link has been demonstrated between cancer and electromagnetic fields (EMF). However, there continues to be much interest in a possible association with breast cancer, in part because breast cancer risk is substantially higher in industrialized countries than in other areas, and electric power generation and consumption is one of the hallmarks of industrialized societies. In 1987, Stevens proposed a biological mechanism whereby two products of electric power generation, EMF and light at night, might contribute to mammary carcinogenesis through inhibition of melatonin. METHODS We conducted a comprehensive review of the epidemiologic literature and hypothesized mechanisms pertaining to EMF exposure and the risk of breast cancer, in order to assess whether or not there was evidence to suggest a link between EMF and breast cancer. RESULTS Some occupational epidemiological studies have demonstrated an increased incidence of breast cancer among mainly male electrical workers. It has been difficult to study women, as few are employed in these types of occupations. In all, there have been eleven occupational studies related to breast cancer in women, and statistically significant risk ratios have been observed: 1.98 for pre-menopausal women in occupations with high EMF exposure in one study, 2.17 in all women who worked as telephone installers, repairers, and line workers in another study, and 1.65 for system analysts/ programmers, 1.40 for telegraph and radio operators, and 1.27 for telephone operators in a third study. However, six of the studies did not find any significant effects and two found effects only in subgroups. The results of the eight studies of residential exposure and four electric blanket studies have been inconsistent, with most not demonstrating any significant association. However, this might be attributed, at least to some extent, to difficulties in assessing residential exposure in these studies, as well as other methodological considerations. CONCLUSIONS The biologic plausibility of an association between EMF and breast cancer, coupled with suggestive data from occupational studies and unexplained high incidence rates of breast cancer, suggests that further investigation of this possible association is warranted.

Development and reliability of a brief skin cancer risk assessment tool

This study aimed to develop and pilot test a brief skin cancer risk assessment tool (BRAT), a self-administered instrument that can be reliably used to assess skin cancer risk. To develop the BRAT, we critically reviewed published literature on risk factors; formulated a draft questionnaire; pilot tested the questionnaire; and retested 1 month later. The BRAT items address the key risk factors for melanoma and other keratinocyte skin cancers: ethnicity, personal and family history of skin cancer, mole count, freckles, childhood residence, sunburn history, and sun sensitivity factors (skin color, natural hair color, ease of sunburning and tanning). One hundred sixty-five persons completed the initial BRAT pilot study, and 52 additional people at moderate- or high-risk completed a second BRAT pilot study. Results were as follows: using a dichotomous risk measure, about 90% of subjects would be correctly classified at baseline and follow-up. Weighted kappa for the total BRAT score (0.41-0.68) and for individual items (0.57-0.99) were fair to good, as were correlation coefficients. The BRAT has acceptable to good reproducibility. Reliability statistics compared favorably with those reported in the literature for similar measures.

Incidence and progression of nuclear opacities in the Longitudinal Study of Cataract.

PURPOSE To estimate incidence and progression rates of nuclear opacities in the Longitudinal Study of Cataract, an epidemiologic study of the natural history of all types of lens opacities. METHODS The Lens Opacities Classification System III was used to assess longitudinal changes between baseline and follow-up lens photographs for the 764 Longitudinal Study of Cataract participants. Baseline data, collected until December 1988 as part of a case-control study, included color slit, retroillumination, and Scheimpflug photographs. The same data were collected by the longitudinal Study of Cataract at four subsequent visits at yearly intervals. RESULTS Among patients free of nuclear opacities at baseline, the incidence of new opacities was 6% after 2 years and 8% after 5 years of follow-up. The progression of pre-existing nuclear opacities was much higher. After 2 years, nuclear opacities had progressed in more than one third of the patients with pre-existing opacities; after 5 years, almost half had progressed. Older age was significantly related to higher incidence of new nuclear opacities, but not to progression of pre-existing opacities. Patients with other opacity types had higher nuclear incidence and progression rates. CONCLUSIONS In this clinic-based, older-patient population, new nuclear opacities developed in less than one tenth of the patients after 5 years of follow-up. In contrast, almost one half of the patients with pre-existing opacities had worsened after 5 years. These estimated rates can be used to plan intervention or other studies of nuclear changes in similar populations.

A randomized trial of tailored skin cancer prevention messages for adults: Project SCAPE.

OBJECTIVES We evaluated the impact of a mailed, tailored intervention on skin cancer prevention and skin self-examination behaviors of adults at moderate and high risk for skin cancer. METHODS Adults at moderate and high risk for skin cancer were recruited in primary health care settings in Honolulu, HI, and Long Island, NY. After completing a baseline survey, participants were randomized to 2 groups. The treatment group received tailored materials, including personalized risk feedback, and the control group received general educational materials. Multivariate analyses compared sun protection and skin self-examination between groups, controlling for location, risk level, gender, and age. RESULTS A total of 596 adults completed the trial. The tailored materials had a significant effect on overall sun-protection habits, the use of hats, the use of sunglasses, and the recency of skin self-examination. Some effects were moderated by location and risk level. CONCLUSIONS Tailored communications including personalized risk feedback can improve sun-protection behaviors and skin self-examination among adults at increased risk for skin cancer. These convenient, low-cost interventions can be implemented in a variety of settings and should be tested further to assess their long-term effectiveness.

Incidence and Progression of Cortical and Posterior Subcapsular Opacities: The Longitudinal Study of Cataract

OBJECTIVE The purpose of the study is to estimate incidence and progression rates of cortical and posterior subcapsular (PSC) opacities in the Longitudinal Study of Cataract (LSC). DESIGN An epidemiologic study of the natural history of lens opacities in a clinic-based population. PARTICIPANTS The LSC was based on 764 participants in an earlier case-control study of lens opacities. MAIN OUTCOME MEASURES Baseline data, collected until 1988, included color slit and retroillumination photographs. The same data were collected at follow-up visits from 1989 to 1993. The Lens Opacities Classification System III (LOCS III) was used to assess lens changes between baseline and follow-up photographs. The product-limit method was used to estimate the incidence and progression rates. RESULTS After 5 years of follow-up, the incidence rates for developing cortical and PSC opacities were 7.7% and 4.3%, respectively. The progression rate of pre-existing cortical opacities was 16.2% after 5 years, and was twice as high as the incidence rate. The progression of pre-existing PSC opacities was much higher, and reached 55.1% after 5 years of follow-up. The incidence of newly developed cortical or PSC opacities increased with age. The incidence of PSC opacities also increased when coexisting opacities were present at baseline. CONCLUSIONS After 5 years, 1 in every 13 patients developed new cortical opacities, and 1 in 24 developed new PSC opacities. The 5-year progression rates for cortical and PSC opacities were much higher than the incidence rates. These results can be used to estimate the rate of cortical and PSC changes in similar populations.

Recruiting Participants for Community-Based Research: The Diabetic Retinopathy Awareness Program

PURPOSE Recruiting participants is a major challenge for population studies. We present the recruitment methods followed by the Diabetic Retinopathy Awareness Program (DRAP), a community-based, randomized, masked, controlled trial to meet and exceed its sample size goals. METHODS A county-wide multi-media promotional campaign to recruit and enroll participants in the trial was planned and executed from October 1993 through April 1994, with the assistance of the local news media and community and professional groups. A toll-free 800 number recruitment line was established, and postage-paid recruitment postcards distributed. The trial was designed to examine whether a mailed educational intervention could increase compliance with vision care guidelines among persons with diabetes in the community. RESULTS A total of 2308 persons with diabetes were interviewed for eligibility and 813 enrolled in the intervention trial, exceeding the original recruitment goals of 1800 and 600, respectively. Those who completed the enrollment interview reflected county demographics. During recruitment, newspaper, television and radio stories featured the study; pharmacies and physician offices displayed study materials; public service announcements appeared in local print and broadcast media. The largest single recruitment response was a local television news report, followed by a newspaper story. CONCLUSIONS These experiences substantiate the need for a comprehensive coordinated approach, using planned multiple sources, to achieve recruitment success. By engaging the lay and professional communities along with the media, recruitment costs can be kept to a minimum. Participant costs can be minimized by employing a toll-free number and eliminating study participant travel, thus allowing for inclusion of traditionally underserved populations. This approach is applicable to other studies, where community-based participation is desired.

Electric blanket use and breast cancer on Long Island

Background: Exposure to electromagnetic fields (EMF) has been hypothesized to increase the risk of breast cancer by inhibiting the normal nocturnal rise in melatonin levels. Methods: Information on electric blanket use was collected in a large, 2-stage, population-based, case-control investigation of breast cancer, The Long Island Breast Cancer Study Project (LIBCSP) and the EMF and Breast Cancer on Long Island Study (EBCLIS). The LIBCSP used a comprehensive questionnaire, including questions about electric appliance use, with responses available on 1354 cases diagnosed between mid-1996 and mid-1997 and 1426 control subjects. EBCLIS enrolled 576 cases and 585 control subjects who had participated in the LIBCSP and who had lived in their current homes for at least 15 years. EBCLIS participants were interviewed to obtain additional information on EMF exposures, including detailed questions on electric blanket use. Results: Analyses of both the EBCLIS and the LIBCSP groups showed no association with breast cancer for ever-use of electric blankets, current or former use, use directly on the body, or use throughout the night in either pre- or postmenopausal women (range of adjusted odds ratios for ever vs. never use: 0.9-1.2). Furthermore, there was no trend in risk with increased duration of use, frequency of use, or other indicators of more intense exposure to EMF. Electric blanket use was not associated with hormone receptor status of the tumor. Conclusions: The results of this large investigation are consistent with those of most previous studies, and do not support the hypothesis that electric blanket use is associated with increased breast cancer risk.