Nancy K. Janz

Interim clinical outcomes in the collaborative initial glaucoma treatment study comparing initial treatment randomized to medications or surgery

PURPOSE To report interim outcome data, using all available follow-up through 5 years after treatment initiation, in the Collaborative Initial Glaucoma Treatment Study (CIGTS). DESIGN Randomized clinical trial. PARTICIPANTS Six hundred seven newly diagnosed glaucoma patients. METHODS In a randomized clinical trial, 607 patients with newly diagnosed open-angle glaucoma were initially treated with either medication or trabeculectomy (with or without 5-fluorouracil). After treatment onset and early follow-up, patients were evaluated clinically at 6-month intervals. In addition, quality of life telephone interviews were conducted at similar frequency to the clinical visits. Patients in both arms of CIGTS were treated aggressively in an effort to reduce intraocular pressure (IOP) to a level at or below a predetermined target pressure specific for each individual eye. Visual field (VF) scores were analyzed by time-specific comparisons and by repeated measures models. MAIN OUTCOME MEASURES VF loss was the primary outcome variable in CIGTS. Secondary outcomes of visual acuity (VA), IOP, and cataract were also studied. RESULTS On the basis of completed follow-up through 4 years and partially completed through 5 years, VF loss did not differ significantly by initial treatment. Over the entire period of follow-up, surgical patients had a greater risk of substantial VA loss compared with medical patients. However, by 4 years after treatment, the average VA in the two groups was about equal. Over the course of follow-up, IOP in the medicine group has averaged 17 to 18 mmHg, whereas that in the surgery group averaged 14 to 15 mmHg. The rate of cataract requiring removal was greater in the surgically treated group. CONCLUSIONS Both initial medical or initial surgical therapy result in about the same VF outcome after up to 5 years of follow-up. VA loss was greater in the surgery group, but the differences between groups seem to be converging as follow-up continues. When aggressive treatment aimed at substantial reduction in IOP from baseline is used, loss of VF can be seen to be minimal in general. Because 4 to 5 years of follow-up in a chronic disease is not adequate to draw treatment conclusions, these interim CIGTS outcomes do not support altering current treatment approaches to open-angle glaucoma.

Self-Management of Chronic Disease by Older Adults A Review and Questions for Research

This article summarizes the literature describing the at-home management of and psychosocial coping with five chronic diseases (heart disease, asthma, chronic obstructive pulmonary disease, arthritis, and diabetes) by the general population of adults. It also reviews the literature describing self-management of these chronic diseases by older adults. Conclusions drawn subsequent to the review are (a) that there are strong commonalities in the essential nature of tasks that exist across disease entities, (b) that the context for self-management of disease by the ill elderly is likely to differ somewhat from the context for other age groups. Questions for future research are posed.

Patient Involvement in Surgery Treatment Decisions for Breast Cancer

PURPOSE High rates of mastectomy and marked regional variations have motivated lingering concerns about overtreatment and failure to involve women in treatment decisions. We examined the relationship between patient involvement in decision making and type of surgical treatment for women with breast cancer. METHODS All women with ductal carcinoma-in-situ and a 20% random sample of women with invasive breast cancer aged 79 years and younger who were diagnosed in 2002 and reported to the Detroit and Los Angeles Surveillance, Epidemiology, and End Results registries were identified and surveyed shortly after receipt of surgical treatment (response rate, 77.4%; n = 1,844). RESULTS Mean age was 60.1 years; 70.2% of the women were white, 18.0% were African American, and 11.8% were from other ethnic groups. Overall, 30.2% of women received mastectomy as initial treatment. Most women reported that they made the surgical decision (41.0%) or that the decision was shared (37.1%); 21.9% of patients reported that their surgeon made the decision with or without their input. Among white women, only 5.3% of patients whose surgeon made the decision received mastectomy compared with 16.8% of women who shared the decision and 27.0% of women who made the decision (P < .001, adjusted for clinical factors, predisposing factors, and number of surgeons visited). However, this association was not observed for African American women (Wald test 10.0, P = .041). CONCLUSION Most women reported that they made or shared the decision about surgical treatment. More patient involvement in decision making was associated with greater use of mastectomy. Racial differences in the association of involvement with receipt of treatment suggest that the decision-making process varies by racial groups.

Visual Field Progression in the Collaborative Initial Glaucoma Treatment Study: The Impact of Treatment and Other Baseline Factors

PURPOSE To evaluate factors associated with visual field (VF) progression, using all available follow-up through 9 years after treatment initiation, in the Collaborative Initial Glaucoma Treatment Study (CIGTS). DESIGN Longitudinal follow-up of participants enrolled in a randomized clinical trial. PARTICIPANTS Six hundred seven newly diagnosed glaucoma patients. METHODS In a randomized clinical trial, 607 subjects with newly diagnosed open-angle glaucoma initially were treated with either medication or trabeculectomy. After treatment initiation and early follow-up, subjects were evaluated clinically at 6-month intervals. Study participants in both arms of the CIGTS were treated aggressively in an effort to reduce intraocular pressure (IOP) to a level at or below a predetermined, eye-specific target pressure. Visual field progression was analyzed using repeated measures models. MAIN OUTCOME MEASURES Visual field progression, measured by Humphrey 24-2 full-threshold testing and assessed by the change in the mean deviation (MD), and an indicator of substantial worsening of the VF (MD decrease of > or =3 dB from baseline), assessed at each follow-up visit. RESULTS Follow-up indicated minimal change from baseline in each initial treatment groups average MD. However, at the 8-year follow-up examination, substantial worsening (> or =3 dB) of MD from baseline was found in 21.3% and 25.5% of the initial surgery and initial medicine groups, respectively. The effect of initial treatment on subsequent VF loss was modified by time (P<0.0001), baseline MD (P = 0.03), and diabetes (P = 0.01). Initial surgery led to less VF progression than initial medicine in subjects with advanced VF loss at baseline, whereas subjects with diabetes had more VF loss over time if treated initially with surgery. CONCLUSIONS The CIGTS intervention protocol led to a lowering of IOP that persisted over time in both treatment groups. Progression in VF loss was seen in a subset, increasing to more than 20% of the subjects. The findings regarding initial surgery being beneficial for subjects with more advanced VF loss at presentation, but detrimental for patients with diabetes, are noteworthy and warrant independent confirmation. FINANCIAL DISCLOSURE(S) The author(s) have no proprietary or commercial interest in any materials discussed in this article.

The Influence of Race, Ethnicity, and Individual Socioeconomic Factors on Breast Cancer Stage at Diagnosis

OBJECTIVES Previous research has generally found that racial/ethnic differences in breast cancer stage at diagnosis attenuate when measures of socioeconomic status are included in the analysis, although most previous research measured socioeconomic status at the contextual level. This study investigated the relation between race/ethnicity, individual socioeconomic status, and breast cancer stage at diagnosis. METHODS Women with stage 0 to III breast cancer were identified from population-based data from the Surveillance, Epidemiology, and End Results tumor registries in the Detroit and Los Angeles metropolitan areas. These data were combined with data from a mailed survey in a sample of White, Black, and Hispanic women (n=1700). Logistic regression identified factors associated with early-stage diagnosis. RESULTS Black and Hispanic women were less likely to be diagnosed with early-stage breast cancer than were White women (P< .001). After control for study site, age, and individual socioeconomic factors, the odds of early detection were still significantly less for Hispanic women (odds ratio [OR]=0.45) and Black women (OR = 0.72) than for White women. After control for the method of disease detection, the White/Black disparity attenuated to insignificance; the decreased likelihood of early detection among Hispanic women remained significant (OR=0.59). CONCLUSION The way in which racial/ethnic minority status and socioeconomic characteristics produce disparities in womens experiences with breast cancer deserves further research and policy attention.

Racial and Ethnic Approaches to Community Health (REACH) Detroit Partnership: Improving Diabetes-Related Outcomes Among African American and Latino Adults

OBJECTIVES We sought to determine the effects of a community-based, culturally tailored diabetes lifestyle intervention on risk factors for diabetes complications among African Americans and Latinos with type 2 diabetes. METHODS One hundred fifty-one African American and Latino adults with diabetes were recruited from 3 health care systems in Detroit, Michigan, to participate in the Racial and Ethnic Approaches to Community Health (REACH) Detroit Partnership diabetes lifestyle intervention. The curriculum, delivered by trained community residents, was aimed at improving dietary, physical activity, and diabetes self-care behaviors. Baseline and postintervention levels of diabetes-specific quality-of-life, diet, physical activity, self-care knowledge and behaviors, and hemoglobin A1C were assessed. RESULTS There were statistically significant improvements in postintervention dietary knowledge and behaviors and physical activity knowledge. A statistically significant improvement in A1C level was achieved among REACH Detroit program participants (P<.0001) compared with a group of patients with diabetes in the same health care system in which no significant changes were observed (P=.160). CONCLUSIONS A culturally tailored diabetes lifestyle intervention delivered by trained community residents produced significant improvement in dietary and diabetes self-care related knowledge and behaviors as well as important metabolic improvements.

The Collaborative Initial Glaucoma treatment study: Interim quality of life findings after Initial medical or surgical treatment of Glaucoma

OBJECTIVE To present interim quality of life (QOL) findings in the Collaborative Initial Glaucoma Treatment Study (CIGTS) using all available follow-up through 5 years from treatment initiation. DESIGN Randomized controlled clinical trial. PARTICIPANTS Six hundred seven newly diagnosed patients with open-angle glaucoma from 14 clinical centers. INTERVENTION Patients were randomly assigned to either initial medical therapy or initial trabeculectomy. After treatment initiation and early follow-up, patients received clinical and QOL evaluations at 6-month intervals. QOL assessments were administered by telephone at a centralized interviewing center. MAIN OUTCOME MEASURES The CIGTS collected comprehensive QOL information that included both generic and vision-specific QOL measures. This article focuses on initial treatment group differences related to symptom reporting, as measured by a Symptom and Health Problem Checklist, and changes in daily visual functioning, as measured by the Visual Activities Questionnaire (VAQ). RESULTS Across both treatment groups, there was an overall decline in the percent of participants reporting symptoms over time. Of 43 possible symptoms, 12 symptoms were reported with greater frequency by the surgically treated group and 7 symptoms more frequently by the medically-treated group. The surgical patients reported more total Symptom Impact Glaucoma (P = 0.005) and, in particular, more bother related to local eye symptoms. Very few treatment group differences were noted in visual functioning, although surgical patients reported more problems with activities related to their visual acuity (P = 0.024). The percentage of patients across treatment groups reporting worry about blindness was 50% at baseline but declined to approximately 25% over time. CONCLUSIONS Overall, the QOL impact reported by the two treatment groups as measured by instruments used in this study is remarkably similar, with relatively few significant study group differences observed after up to 5 years of follow-up in the CIGTS. When significant differences in visual function have been detected using the VAQ, they are consistent with the clinical outcomes. To date, the most persistent QOL finding is the increased impact of local eye symptoms reported by the surgical group compared with the medical group. Although no changes are recommended in the treatment of newly diagnosed glaucoma patients at the time of this interim report, further follow-up will allow for more definitive answers to the QOL impact of these two treatment approaches.

Population-based study of the relationship of treatment and sociodemographics on quality of life for early stage breast cancer.

Objective: To examine the relationship between cancer stage, surgical treatment and chemotherapy on quality of life (QOL) after breast cancer and determine if sociodemographic characteristics modify the observed relationships. Methods: A population-based sample of women with Stages 0–II breast cancer in the United States (N=1357) completed surveys including the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and the Breast Cancer-Specific Quality of Life Questionnaire (QLQ BR-23). Regression models calculated mean QOL scores across primary surgical treatment and chemotherapy. Clinically significant differences in QOL were defined as 10 point difference (out of 100) between groups. Results: Meaningful differences in QOL by surgical treatment were limited to body image with women receiving mastectomy with reconstruction reporting lower scores than women receiving breast conserving surgery (p < 0.001). Chemotherapy lowered QOL scores overall across four QOL dimensions (p values < 0.001), with a disproportionately greater impact on those with lower levels of education. Younger women reported lower QOL scores for seven of nine QOL dimensions (p values < 0.001). Conclusions: Women should be reassured that few QOL differences exist based on surgical treatment, however, clinicians should recognize that the impact of treatment on QOL does vary by a woman’s age and educational level.

Evaluation of a minimal-contact smoking cessation intervention in an outpatient setting.

We examined the ability of a provider-initiated, minimal-contact intervention to modify the smoking behavior of ambulatory clinic patients. Smokers at two outpatient sites were assigned to one of three groups: provider intervention only (PI); provider intervention plus self-help manual (PI/M); and usual care (control) group (C). The physician message emphasized the patients personal susceptibility, the physicians concern, and the patients ability to quit (self-efficacy). The nurse consultation concentrated on benefits and barriers associated with stopping, and on strategies for cessation. Telephone interviews were conducted with the 250 participants within a few days of their clinic visit and again at one and six months. Both PI and PI/M proved to be superior to usual care in motivating attempts to quit at both one-month and six-month follow-ups, and logistic regression analyses indicated that participants receiving the self-help manual in addition to the health provider message were between two and three times more likely to quit smoking during the study period than were participants in either of the other study groups.

Patterns and Correlates of Local Therapy for Women With Ductal Carcinoma-In-Situ

PURPOSE Concerns have been raised about the quality of treatment for women with ductal carcinoma-in-situ (DCIS) because persistent high rates of mastectomy suggest overtreatment, whereas lower than expected rates of radiation therapy after breast-conserving surgery (BCS) suggest undertreatment. PATIENTS AND METHODS All women with DCIS diagnosed in 2002 and who reported to the Detroit and Los Angeles Surveillance, Epidemiology, and End Results (SEER) registries were identified and surveyed shortly after receipt of surgery (response rate, 79.7%; n = 817). Analyses were restricted to patients with DCIS (n = 659) indicated by SEER stage data. RESULTS Only 14.0% of patients at lowest risk of recurrence (based on tumor size and histologic grade) received a mastectomy compared with 22.8% and 52.6% of patients at intermediate and highest risk (P < .001). Only 13.1% of patients who were not influenced or slightly influenced by concerns about recurrence received mastectomy compared with 48.8% of women who were greatly influenced by this concern (P < .001). A between-geographic site difference in receipt of radiation after BCS was observed for the lowest risk group (38.9% in Los Angeles v 70.5% in Detroit) but not for the highest risk group (80.2% in Los Angeles v 85.9% in Detroit, P = .006 for site and risk group differences). Between-site differences in receipt of radiation after BCS were consistent with patient recall of surgeon discussions about treatment. CONCLUSION Surgeons are tailoring their recommendations for local therapy options for DCIS based on important clinical factors. Patient attitudes also play an important role in treatment decisions. The substantial influence of both surgeon opinion and patient attitudes should temper concerns about the quality of treatment for women with DCIS.