To evaluate the relationship between medication adherence and visual field progression in participants randomized to the medication arm of the Collaborative Initial Glaucoma Treatment Study (CIGTS).
...The CIGTS was a randomized, multicenter clinical trial comparing initial treatment with topical medications to trabeculectomy for 607 participants with newly diagnosed glaucoma.
Three hundred seven participants randomized to the medication arm of the CIGTS.
Participants were followed up at 6-month intervals for up to 10 years. Self-reported medication adherence and visual fields were measured. Medication adherence was assessed by telephone from responses to the question, "Did you happen to miss any dose of your medication yesterday?" The impact of medication adherence on mean deviation (MD) over time was assessed with a linear mixed regression model adjusting for the effects of baseline MD and age, cataract extraction, interactions, and time (through year 8, excluding time after crossover to surgery). Medication adherence was modeled as a cumulative sum of the number of prior visits where a missed dose of medication was reported.
Mean deviation over time.
Three hundred seven subjects (306 with adherence data) were randomized to treatment with topical medications and followed up for an average of 7.3 years (standard deviation, 2.3 years). One hundred forty-two subjects (46%) reported never missing a dose of medication over all available follow-up, 112 patients (37%) reported missing medication at up to one third of visits, 31 patients (10%) reported missing medication at one third to two thirds of visits, and 21 patients (7%) reported missing medication at more than two thirds of visits. Worse medication adherence was associated with loss of MD over time (P = 0.005). For subjects who reported never missing a dose of medication, the average predicted MD loss over 8 years was 0.62 dB, consistent with age-related loss (95% confidence interval CI, 0.17-1.06; P = 0.007); subjects who reported missing medication doses at one third of visits had a loss of 1.42 dB (95% CI, 0.86-1.98; P < 0.0001); and subjects who reported missing medication doses at two thirds of visits showed a loss of 2.23 dB (95% CI, 1.19-3.26; P < 0.0001).
This longitudinal assessment demonstrated a statistically and clinically significant association between medication nonadherence and glaucomatous vision loss.
There is concern that minority women have limited access to breast reconstruction. We described patterns of use, experiences with clinicians, and patients' satisfaction with treatment decisions for ...women of different race/ethnicities.
A total of 3,252 patients with breast cancer from Los Angeles and Detroit Surveillance, Epidemiology, and End Results registries were surveyed near the time of diagnosis (n = 2,260, response rate 72.2%). The primary outcomes were receipt of reconstruction, access to information about reconstruction, and decisional satisfaction. The primary independent variable was race/ethnicity (white, African American AA, highly acculturated Latina Latina-high, and less acculturated Latina Latina-low). Control variables included other sociodemographic and clinical factors. chi(2) and multivariate logistic regression were used for the analyses.
Receipt of reconstruction varied significantly by patient race/ethnicity-40.9% of whites, 33.5% of AAs, 41.2% of Latina-high, and only 13.5% of Latina-low (P < .001)-and persisted when we controlled for demographic and clinical factors. Minority women were significantly less likely than whites to see a plastic surgeon before initial surgery and were more likely to desire more information about reconstruction (17.0% of whites v 27.0% of AAs, 30.0% of Latina-high, and 55.9% of Latina-low; P < .001). Decisional satisfaction was lowest among minority women without reconstruction (P < .001).
Minority women, particularly less acculturated Latinas, had low receipt of breast reconstruction, which may be related to limited information about the procedure and less access to plastic surgeons. Greater desire for information and lower satisfaction with surgical decisions among these patients motivate greater attention to treatment support for these patients.
The growing rate of contralateral prophylactic mastectomy (CPM) among women diagnosed as having breast cancer has raised concerns about potential for overtreatment. Yet, there are few large survey ...studies of factors that affect women's decisions for this surgical treatment option.
To determine factors associated with the use of CPM in a population-based sample of patients with breast cancer.
A longitudinal survey of 2290 women newly diagnosed as having breast cancer who reported to the Detroit and Los Angeles Surveillance, Epidemiology, and End Results registries from June 1, 2005, to February 1, 2007, and again 4 years later (June 2009 to February 2010) merged with Surveillance, Epidemiology, and End Results registry data (n = 1536). Multinomial logistic regression was used to evaluate factors associated with type of surgery. Primary independent variables included clinical indications for CPM (genetic mutation and/or strong family history), diagnostic magnetic resonance imaging, and patient extent of worry about recurrence at the time of treatment decision making.
Type of surgery received from patient self-report, categorized as CPM, unilateral mastectomy, or breast conservation surgery.
Of the 1447 women in the analytic sample, 18.9% strongly considered CPM and 7.6% received it. Of those who strongly considered CPM, 32.2% received CPM, while 45.8% received unilateral mastectomy and 22.8% received breast conservation surgery (BCS). The majority of patients (68.9%) who received CPM had no major genetic or familial risk factors for contralateral disease. Multivariate regression showed that receipt of CPM (vs either unilateral mastectomy or breast conservation surgery) was significantly associated with genetic testing (positive or negative) (vs UM, relative risk ratio RRR: 10.48; 95% CI, 3.61-3.48 and vs BCS, RRR: 19.10; 95% CI, 5.67-56.41; P < .001), a strong family history of breast or ovarian cancer (vs UM, RRR: 5.19; 95% CI, 2.34-11.56 and vs BCS, RRR: 4.24; 95% CI, 1.80-9.88; P = .001), receipt of magnetic resonance imaging (vs UM RRR: 2.07; 95% CI, 1.21-3.52 and vs BCS, RRR: 2.14; 95% CI, 1.28-3.58; P = .001), higher education (vs UM, RRR: 5.04; 95% CI, 2.37-10.71 and vs BCS, RRR: 4.38; 95% CI, 2.07-9.29; P < .001), and greater worry about recurrence (vs UM, RRR: 2.81; 95% CI, 1.14-6.88 and vs BCS, RRR: 4.24; 95% CI, 1.80-9.98; P = .001).
Many women considered CPM and a substantial number received it, although few had a clinically significant risk of contralateral breast cancer. Receipt of magnetic resonance imaging at diagnosis contributed to receipt of CPM. Worry about recurrence appeared to drive decisions for CPM although the procedure has not been shown to reduce recurrence risk. More research is needed about the underlying factors driving the use of CPM.
Contralateral prophylactic mastectomy (CPM) use is increasing among women with unilateral breast cancer, but little is known about treatment decision making or physician interactions in diverse ...patient populations.
To evaluate patient motivations, knowledge, and decisions, as well as the impact of surgeon recommendations, in a large, diverse sample of patients who underwent recent treatment for breast cancer.
A survey was sent to 3631 women with newly diagnosed, unilateral stage 0, I, or II breast cancer between July 2013 and September 2014. Women were identified through the population-based Surveillance Epidemiology and End Results registries of Los Angeles County and Georgia. Data on surgical decisions, motivations for those decisions, and knowledge were included in the analysis. Logistic and multinomial logistic regression of the data were conducted to identify factors associated with (1) CPM vs all other treatments combined, (2) CPM vs unilateral mastectomy (UM), and (3) CPM vs breast-conserving surgery (BCS). Associations between CPM receipt and surgeon recommendations were also evaluated. All statistical models and summary estimates were weighted to be representative of the target population.
Receipt of CPM was the primary dependent variable for analysis and was measured by a woman's self-report of her treatment.
Of the 3631 women selected to receive the survey, 2578 (71.0%) responded and 2402 of these respondents who did not have bilateral disease and for whom surgery type was known constituted the final analytic sample. The mean (SD) age was 61.8 (12) years at the time of the survey. Overall, 1301 (43.9%) patients considered CPM (601 24.8% considered it very strongly or strongly); only 395 (38.1%) of them knew that CPM does not improve survival for all women with breast cancer. Ultimately, 1466 women (61.6%) received BCS, 508 (21.2%) underwent UM, and 428 (17.3%) received CPM. On multivariable analysis, factors associated with CPM included younger age (per 5-year increase: odds ratio OR, 0.71; 95% CI, 0.65-0.77), white race (black vs white: OR, 0.50; 95% CI, 0.34-0.74), higher educational level (OR, 1.69; 95% CI, 1.20-2.40), family history (OR, 1.63; 95% CI, 1.22-2.17), and private insurance (Medicaid vs private insurance: OR, 0.47; 95% CI, 0.28-0.79). Among 1569 patients (65.5%) without high genetic risk or an identified mutation, 598 (39.3%) reported a surgeon recommendation against CPM, of whom only 12 (1.9%) underwent CPM, but among the 746 (46.8%) of these women who received no recommendation for or against CPM from a surgeon, 148 (19.0%) underwent CPM.
Many patients consider CPM, but knowledge about the procedure is low and discussions with surgeons appear to be incomplete. Contralateral prophylactic mastectomy use is substantial among patients without clinical indications but is low when patients report that their surgeon recommended against it. More effective physician-patient communication about CPM is needed to reduce potential overtreatment.
Objective We sought to estimate the minimum important difference (MID) for the Urinary Distress Inventory (UDI), UDI-stress subscale of the Pelvic Floor Distress Inventory, and Urinary Impact ...Questionnaire (UIQ) of the Pelvic Floor Impact Questionnaire. Study Design We calculated MID using anchor- and distribution-based approaches from a randomized trial for nonsurgical stress incontinence treatment. Anchors included a global impression of change, incontinence episodes from a urinary diary, and the Incontinence Severity Index. Effect size and standard error of measurement were the distribution methods used. Results Anchor-based MIDs ranged from -22.4 to -6.4 points for the UDI, -16.5 to -4.6 points for the UDI-stress, and -17.0 to -6.5 points for the UIQ. These data were supported by 2 distribution-based estimates. Conclusion Reasonable estimates of MID are 11, 8, and 16 points for the UDI, UDI-stress subscale, and UIQ, respectively. Statistically significant improvements that meet these thresholds should be considered clinically important.
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).
Longitudinal follow-up of participants enrolled in a randomized clinical trial.
Six hundred seven newly diagnosed glaucoma patients.
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.
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.
Follow-up indicated minimal change from baseline in each initial treatment group's 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.
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.
The author(s) have no proprietary or commercial interest in any materials discussed in this article.
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.
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).
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).
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.
To characterize longitudinal trends and factors predictive of depressive symptoms following glaucoma diagnosis in Collaborative Initial Glaucoma Treatment Study (CIGTS) participants.
Cohort study ...using follow-up data from a clinical trial.
A total of 607 participants with newly diagnosed open-angle glaucoma were enrolled at 14 clinical centers in the United States from October 1993 through April 1997, randomized to treatment with medication or surgery, and followed every 6 months through 2004. The 8-item Center for Epidemiologic Studies Depression Scale (CES-D) was administered at baseline and follow-up visits. Three outcome measures were investigated: overall CES-D depression score, presence of mild or worse depression (CES-D score ≥ 7), and number of depressive symptoms endorsed.
The average baseline CES-D score was 2.4 (SD = 3.8), 12.5% of subjects reported symptoms associated with mild or worse depression, and 55.3% reported at least 1 depressive symptom. By 1 year posttreatment, depression measures decreased (1.5, 6.7%, and 38.4%, respectively), with modest decreases thereafter. Baseline factors predictive of mild or worse depression included worse vision-related quality of life (VRQOL) (odds ratio OR = 2.41), female sex (OR = 1.42), younger age (OR per 10 years younger = 1.24), and less than high school education (OR = 2.93); other outcomes showed similar results.
Depressive symptoms decreased considerably during the first year after treatment initiation, but were elevated in those with impaired VRQOL. Given the potential of depression to reduce treatment adherence and thus increase the risk of glaucoma progression, eye care providers should ask patients about depressive symptoms, provide reassurance when appropriate, and make referrals as necessary.
•In this study of 607 newly diagnosed glaucoma patients, depressive symptoms initially evident in 12.5% of participants diminished over time (6.7% at 1 year) and remained lower over 9-year follow-up.•Participants who were younger, female, or less educated or who had poorer vision-related quality of life were more likely to experience depressive symptoms.•While depressive symptoms diminish over time after diagnosis, care providers need to monitor for these symptoms and be aware of who are more likely to experience them.
PDF
