The Association between Educational Attainment and Patterns of Emergency Department Utilization among Adults with Sickle Cell Disease.

PURPOSE: Patients with low educational attainment may be at increased risk for unplanned health care utilization. This study aimed to determine what factors are related to emergency department (ED) visits in hopes of guiding treatments and early interventions. METHODS: At two medical centers in the Mid-Atlantic United States, 258 adults with sickle cell disease aged 19-70 years participated in a retrospective study where we examined whether education level is independently associated with ED visits after accounting for other socioeconomic status (SES) variables, such as pain and disease severity and psychosocial functioning. RESULTS: The data showed that patients without a high school education visited the ED three times as frequently as patients with post secondary education. Controlling for poverty and employment status decreased the effect of education on ED visits by 33.24 %. Further controlling for disease severity and/or psychosocial functioning could not account for the remaining association between education and ED visits, suggesting that education is independently associated with potentially avoidable emergency care. CONCLUSIONS: Early interventions addressing disparities in academic performance, especially for those children most at risk, may lead to improved long-term health outcomes in this population.

The role of men in women's acceptance of an intravaginal gel in a randomized clinical trial in Blantyre, Malawi: a qualitative and quantitative analysis.

Survey questionnaires and focus group discussions were used to investigate the association between a female participant's acceptance and her perception of her male partner's acceptance of an intravaginal gel as a prototype microbicide. Women who perceived their male partners would accept using the gel were more likely to highly accept the gel as compared to women who perceived their male partners would not accept using the gel (OR=24.57; 95%CI: 16.49-36.61). Qualitative analysis supported a positive association between female acceptability and perceived male partner acceptability. Qualitative research reiterated this finding and also found that men and women had different approaches to assess gel acceptability. Women integrated perceptions of their partner's acceptance into their own acceptability and reported their partners had positive experiences. In contrast, men reported a more neutral experience with the gel and assessed the gel without overt consideration of their partner's experiences. These results indicate that female perceptions of male partner acceptability and actual male partner acceptability need to be considered when addressing female-controlled product acceptability and use.

Incidence of ocular complications in patients with multibacillary leprosy after completion of a 2 year course of multidrug therapy.

AIM: To evaluate the incidence of and risk factors for ocular complications in multibacillary (MB) leprosy patients following completion of 2 year, fixed duration, multidrug therapy (MDT). METHODS: Biannual eye examinations were conducted prospectively on a cohort of MB patients who had completed MDT and followed up for 5 years. The incidence of ocular pathology was calculated as the number of events per person year of event free follow up of patients who did not have the specific finding before completion of MDT. RESULTS: 278 patients had one or more follow up visits after completion of MDT. The incidence of lagophthalmos was 0.24%/patient year (95% CI 0.10% to 0.37%); corneal opacity, 5.35%/patient year (95% CI 4.27% to 6.70%); uveal involvement, 3.78%/patient year (95% CI 2.96% to 4.83%); and cataract that reduced vision to 6/18 or less, 2.4%/patient year (95% CI 1.77% to 3.26%). Overall, 5.65%/patient year (95% CI 4.51% to 7.09%) developed leprosy related ocular disease and 3.86%/patient year (95% CI 3.00% to 4.95%) developed leprosy related, potentially blinding ocular pathology during the period following MDT. Age and other disability also predicted incident eye disease. CONCLUSIONS: Every year, approximately 5.6% of patients with MB who have completed MDT can be expected to develop new ocular complications of leprosy, which often (3.9%) are potentially vision threatening. Because many of these complications cannot be detected without slit lamp examination, periodic monitoring, particularly of older patients and those with other disability, is recommended, in order to detect and treat ocular complications satisfactorily.

Incidence of ocular morbidity among multibacillary leprosy patients during a 2 year course of multidrug therapy.

AIM: To evaluate the incidence of and risk factors for ocular complications in multibacillary (MB) leprosy patients during their 2 year, fixed duration, multidrug therapy (MDT). METHODS: Periodic eye examinations were conducted prospectively on a cohort of 301 consecutive newly diagnosed MB patients every 6 months during their 2 year course of MDT. Incidence of ocular pathology was calculated as the number of events per person year of event free follow up of patients who did not have the specific finding at baseline. RESULTS: 292 (97%) patients had one or more follow up visits. The incidence of lagophthalmos was 1.2%/patient year (95% CI 0.5% to 2.8%); corneal opacity was 7.4%/patient year (95% CI 5.1% to 10.6%); uveal involvement was 5.1%/patient year (95% CI 3.3% to 7.8%), and cataract that reduced vision to 6/18 or less was seen in 4.3%/patient year (95% CI 2.7% to 6.9%) of patients. Overall, 23 individuals (5.8%/patient year, 95% CI 3.9 to 8.8) developed leprosy related potentially blinding pathology during the 2 years of MDT. CONCLUSIONS: Approximately 20% of patients with MB leprosy can be expected to develop ocular complications of leprosy during a 2 year course of MDT, many (11%) of which are potentially vision threatening. Ophthalmological monitoring to detect and treat ocular complications at defined intervals during MDT is indicated.

Randomized dose-searching phase ILE/II trials of fractionation in radiation therapy for cancer.

This article describes a new design, phase ILE/II dose searching, used in four prospective, randomized, multicenter clinical trials of escalating total doses of hyperfractionated radiation. This design combines an experimental protocol with a statistical application of ranking and selection theory. Its purpose was to identify (within a certain margin of error) a dose that achieved the highest rate of clinical response from a set of doses that were tolerable in terms of both acute (within 90 days) and late (more than 90 days) toxic effects (LE). We calculated the number of patients required to reliably test toxicity under various assumptions. To determine the maximum tolerated total dose for hyperfractionated radiation, we randomly assigned patients with tumors that responded to radiation therapy in a dose-dependent manner from four body sites (lung, upper respiratory and digestive tract, bladder, and brain) to one of three regimens receiving total doses (D1, D2, or D3) differing by increments of 4.8 Gy. All patients received two fractions of 1.2 Gy each (separated by 4-6 hours) daily 5 days a week. The lowest total dose was set at the level considered tolerable with standard once-a-day radiation therapy. We tested tumor responses and late toxic effects of higher doses by assigning patients to these three regimens until acute effects and early estimates of late effects were found to be acceptable for the highest dose D3; thereafter, regimen D1 was closed, and additional patients were assigned to D2, D3, and D4 (an escalated total dose greater than D3 by an increment of 4.8 Gy). The assignment of patients was performed in a weighted manner (1:1:2), so that greater numbers were assigned to the highest dose regimen (whether D3 or D4) to allow rapid evaluation of the feasibility of the highest dose.

Identification of an optimal subgroup for treatment evaluation of patients with brain metastases using RTOG study 7916.

The overall poor prognosis of brain metastases patients has complicated the evaluation of treatment effectiveness in previous clinical trials involving radiation therapy. Therapy has not been seen to alter survival, which is generally short in these patients. Possible benefits of the treatments tested may be better assessed using a favorable group of patients who are at lower risk of dying quickly from cancer. The determination of a patient subgroup having prolonged survival allows for improvement in the design and analysis of subsequent clinical trials. An optimal patient group was identified in an RTOG study (7916) that evaluated two fractionation schedules (30 Gy/10 fractions/2 weeks and 20 Gy/6 fractions/3 weeks) with or without the administration of misonidazole (MISO) in the treatment of brain metastases. A Cox regression model was used to identify the pretreatment characteristics associated with a favorable prognosis for survival: Karnofsky Performance Status (KPS) of 70-100, an absent/controlled primary tumor, age less than 60 years, and metastatic spread limited to the brain. A logistic model confirmed that the odds of surviving at least 200 days depend on these pretreatment characteristics. Patients with all four favorable characteristics constitute 11% of the evaluable study population and have a predicted 200 day survival of 52%. Prognostically favorable subgroups have been identified as patients having at least three of these four favorable characteristics. These patients have predicted probabilities of 200 day survival between 33 and 52%. Conversely, unfavorable subgroups are defined as patients having two or less favorable characteristics. Subsequent verification of these results by a second data set is warranted. The prognostically favorable characteristics have been used to define the patient population in a current RTOG study evaluating accelerated radiation therapy in patients with brain metastases.

A randomized comparison of misonidazole sensitized radiotherapy plus BCNU and radiotherapy plus BCNU for treatment of malignant glioma after surgery: final report of an RTOG study.

This randomized RTOG study evaluated misonidazole radiosensitized radiation therapy in the treatment of malignant glioma. One hundred and forty-six evaluable patients were treated with conventional radiation therapy to 60.00 Gy in 6-7 weeks plus BCNU 80 mg/m2/d for 3 days every 8 weeks (XRT + BCNU). One hundred and forty-seven evaluable patients were treated with misonidazole 2.5 gm/m2 once a week for 6 weeks, radiation therapy to 60 Gy and BCNU (MISO + XRT + BCNU). Patients were stratified according to the prognostic factors of age, performance status, and histology. Distribution of these characteristics was comparable among the treatment groups. The median survival for XRT + BCNU was 55.0 weeks, and for MISO + XRT + BCNU 46.0 weeks (p = 0.35). With patients on a minimum dose of dexamethasone of 3 mg/d, misonidazole neurotoxicity included 8.8% peripheral neuropathy, 2.7% CNS toxicity, and a 0.68% ototoxicity. BCNU pulmonary toxicity occurred in 9.3% of patients who received 902-2062 mg/m2 of BCNU.

Hyperfractionation in the radiation therapy of unresectable non-oat cell carcinoma of the lung: preliminary report of a RTOG Pilot Study.

Patients with localized unresectable non-oat cell carcinoma of the lung were treated by supervoltage radiation therapy to the primary tumor, mediastinum and supraclavicular lymph nodes with 50.4 Gy, 42 fractions of 1.2 Gy, twice daily, 4 to 6 hours apart, 5 times a week. Small field treatment to the known involved areas of primary and lymph nodes was given from 9.6 to 24 Gy, also with 1.2 Gy, twice daily. One hundred twenty-five patients were entered, three of whom were cancelled and two were ineligible. Of the remaining 120 eligible patients, 10 patients received a dose of 50.4 Gy, 20 received 60.0 Gy, 79 received 69.6 Gy and 11 patients received 74.4 Gy. Of these, nine patients were unable to complete hyperfractionated radiation therapy for various reasons. Treatment was discontinued or stopped in 14 patients because of early death or deterioration of the patient's condition. Four additional patients were found to have unacceptable doses to tumor or normal tissues, for a total of 27 patients with protocol violations. Complete regression occurred in 19% of T1-T3, N0-N2 patients with 9% among T3.3b, T4 or N3 patients. Partial regression was 29 and 41%, respectively. There were six cases of severe and two of life-threatening toxicity, but there were no fatalities attributable to the treatment. Toxicity consisted mainly of pneumonitis and pulmonary fibrosis as well as esophagitis. Median survival of the entire group was 7.2 months, which is consistent with previous experience with the treatment of localized inoperable non-oat cell carcinoma of the lung by radiation therapy. Further study of this method of treatment is warranted.

Randomized neutron dose searching study for malignant gliomas of the brain: results of an RTOG study. Radiation Therapy Oncology Group.

From September 1980 through January 1985, the Radiation Therapy Oncology Group (RTOG) conducted a randomized, dose-searching study testing the efficacy of a concomitant neutron boost along with whole brain photon irradiation in the treatment of malignant gliomas of the brain. Patients had to have biopsy-proven, supratentorial, anaplastic astrocytoma or glioblastoma multiforme (Nelson schema) to be eligible for the study. The whole brain photon irradiation was given at 1.5 Gy per treatment, 5 days-a-week to a total dose of 45 Gy. Two days-a-week the patients were to receive neutron boost irradiation to the tumor volume as determined on CT scans. The neutron irradiation was to be given prior to and within 3 hours of the photon irradiation on that day. The rationale for this particular treatment regime is discussed. A total of 190 evaluable patients were randomized among 6 different neutron dose levels: 3.6, 4.2, 4.8, 5.2, 5.6 and 6.0 Gyn gamma. There was no difference in overall survival among the 6 different dose levels, but for patients having less aggressive tumor histology (anaplastic astrocytoma), there was a suggestion that patients on the higher dose levels had poorer overall survival than patients on the lower dose levels and also did worse than historical photon controls. Important prognostic factors were identified using a Cox stepwise regression analysis. Tumor histology, Karnofsky performance status, and patient age were found to be related to survival while extent of surgery and neutron dose had no significant impact. Autopsies were performed on 35 patients and the results correlated with the actual neutron dose as determined by central-axis isodose calculations. At all dose levels there were some patients with both radiation damage to normal brain tissue and evidence of viable tumor. No evidence was found for a therapeutic window using this particular treatment regimen.

Reproducibility of the diagnosis of endometrial hyperplasia, atypical hyperplasia, and well-differentiated carcinoma.

Many studies have attempted to identify histologic features that aid in the distinction of atypical hyperplasia (AH) from hyperplasia without atypia and well-differentiated endometrioid carcinoma, but few have evaluated the reproducibility of these diagnoses. Five pathologists independently reviewed 100 endometrial biopsy and curettage specimens chosen to represent the entire spectrum of proliferative lesions of the endometrium, including proliferative endometrium (PEM), hyperplasia without atypia, AH, and well-differentiated endometrioid carcinoma. Slides were reviewed twice for diagnosis, with an intervening evaluation of a checklist of histologic features. Intraobserver and interobserver agreement were assessed using the kappa statistic. Intraobserver kappa values ranged from 0.67 to 0.89 (76% to 89% agreement). Interobserver kappa values by diagnostic category were: proliferative endometrium: 0.86; hyperplasia without atypia: 0.60; AH: 0.47; well-differentiated endometrioid carcinoma: 0.83; with a kappa value of 0.69 for all cases combined. Associations between the selected histologic features and the given diagnoses for each pathologist were analyzed using multiple logistic regressions to identify features that were useful for distinguishing among diagnostic categories. Histologic features determined by univariable and multivariable analyses that were found to be most associated with distinguishing diagnostic categories were: proliferative endometrium versus hyperplasia without atypia: gland crowding (univariable, multivariable), and gland branching (univariable); hyperplasia without atypia versus AH: presence of nucleoli (univariable, multivariable), nuclear enlargement (univariable), vesicular chromatin change (univariable), nuclear pleomorphism (univariable), chromatin irregularities (univariable), and loss of polarity (univariable); hyperplasia without atypia versus carcinoma: glandular confluence/complex cribriform pattern (univariable, multivariable), stromal alteration (univariable, multivariable), and necrosis (univariable). In summary, interobserver agreement was good but was lowest for AH. Only the presence of nucleoli was strongly associated with distinction of AH from hyperplasia without atypia. Individual pathologists use additional features to diagnose atypia, but these features are not consistently associated with that diagnosis. Cribriform architectural pattern and stromal alteration were associated with the distinction of well-differentiated endometrioid carcinoma from AH.

Reducing racial disparities in transplant activation: whom should we target?

Several studies have documented that blacks with end-stage renal disease (ESRD) are less likely than whites to be placed on the waiting list for a renal transplant. We examined trends in access over time to determine whether publication of these reports resulted in a reduction in disparity and identified those blacks who were most affected to focus future interventions. Three nationally representative groups of adult patients with ESRD (first dialysis in 1986 to 1987, 1990, or 1993) were followed up longitudinally to ascertain the date of first placement on the renal transplant waiting list. Cox proportional hazards models were used to characterize the magnitude of racial disparities in access to the waiting list with adjustment for clinical and sociodemographic factors. Lower rates of placement on the waiting list for blacks than whites persisted after adjustment for differences in both sociodemographic characteristics and health status (relative hazard [RH], 0.68; 95% confidence interval [CI], 0.59 to 0.79). The gap between blacks and whites did not narrow over time (blacks versus whites: 1986 to 1987 group, RH, 0.71; 95% CI, 0.59 to 0.86; 1990 group, RH, 0.69; 95% CI, 0.54 to 0.91; 1993 group, RH, 0.57; 0.43 to 0.77) and was greatest for the youngest and healthiest black patients, who were 50% and 40% less likely to be listed than corresponding whites, respectively. Interventions targeted toward young and healthy blacks, who are most likely to benefit from transplantation, are urgently needed to narrow black-white differences in transplant activation.

Income-based disparities in outcomes for patients with chronic kidney disease.

The impact of income on outcomes for patients with end-stage renal disease (ESRD), who are largely relieved of structural and financial barriers to care, is poorly understood. We conducted a prospective cohort study of 3,165 patients who developed ESRD in the early 1990s to examine whether low-income patients with ESRD have poorer health outcomes than their socioeconomically advantaged counterparts, and, if so, to determine whether greater health insurance can reduce this disparity. We found that increasing neighborhood income was associated with decreased mortality and an increased likelihood of placement on the renal transplant waiting list. The presence of private insurance coverage in addition to Medicare improved rates of listing for transplantation in a graded manner, with the greatest effect among those living in neighborhoods below the 10th percentile of income, but had no effect on socioeconomic disparities in mortality. Our results suggest that low-income patients with ESRD experience persistent financial barriers to transplantation that can be addressed with greater health benefits. However, they also experience higher mortality that is caused by personal and/or environmental factors that differ by social class. Clinicians, researchers, and policymakers must address these social, cultural, psychologic, and environmental determinants of health to improve the survival of patients with ESRD.

A review of mortality from choroidal melanoma. I. Quality of published reports, 1966 through 1988.

The literature concerning mortality after a diagnosis of choroidal melanoma was reviewed to identify relevant articles published from 1966 through 1988 and to select those with mortality rates presented separately by tumor size for inclusion in a pooled analysis (meta-analysis) of 5-year mortality after enucleation for choroidal melanoma. The quality of the published literature for our purposes was assessed. Candidate articles were identified from a search of the MEDLINE files by an information specialist. Altogether, of 217 candidate articles, 76 (70 from the MEDLINE search and six more from our files) qualified for review. All-cause mortality rates were reported in 80% of the articles. Among six aspects of design and methods for which information was sought, eligibility criteria were reported in 52 (68%) of the 76 articles and statistical methods were cited in 38 (50%); other information was reported with intermediate frequency. Quality scores based on completeness of reporting with respect to 16 factors ranged from 13.3 to 92.3 of a possible 100.0. Findings suggest that researchers, clinicians, journal editors, and reviewers should be more attentive to the completeness of reports from clinical research studies with respect to basic information regarding design and methods.

A review of mortality from choroidal melanoma. II. A meta-analysis of 5-year mortality rates following enucleation, 1966 through 1988.

With the use of data published during the period from 1966 through 1988, a pooled analysis (meta-analysis) of 5-year mortality rates among patients who had an eye enucleated for choroidal melanoma was performed to provide a more robust estimate of this rate than could be obtained from any single study. The literature concerning mortality following a diagnosis of choroidal melanoma has been reviewed systematically and described in a separate article. Of 76 reports published from 1966 through 1988, 29 were excluded from the meta-analysis because there were no cases treated by enucleation alone, mortality was not reported by time from enucleation, fewer than 10 cases were reported, or 5-year mortality rates were not reported or derivable from the data presented. Ten additional reports were excluded because they were based on data for the same set of patients as another article in the series. Of the remaining 37 reports, 29 contained data for patients with tumors of varying sizes that could not be separated into subgroups based on the size of the tumor at the time of treatment. The remaining eight articles reported 5-year mortality rates by tumor size, specifically for small, medium, or large tumors. The combined weighted estimates of 5-year mortality rates following enucleation were 16% for small tumors (95% confidence interval [CI]: [14%, 18%]), 32% for medium tumors (95% CI: [29%, 34%]), and 53% for large tumors (95% CI: [50%, 56%]). Different methods of pooling the data yielded consistent estimates for all three tumor size categories.(ABSTRACT TRUNCATED AT 250 WORDS)

Observations on patients with idiopathic macular holes and cysts.

We reexamined 96 patients with macular holes or cysts. The mean follow-up period was 4.7 years. Of 19 eyes with macular cysts, only two (10.5%) showed progression to a macular hole. In 15 (79%) of those 19 eyes, the cyst disappeared. Of 80 patients with a macular hole or cyst in one eye and a normal fellow eye, a hole developed in the fellow eye in only one patient (1.2%) and a cyst developed in the fellow eye in only two patients (2.5%). Of 66 eyes with a stage 3 full-thickness macular hole, three eyes (5%) showed resolution without any sign of a hole. Our results suggest a favorable prognosis for normal fellow eyes of patients with macular holes or cysts and for eyes with cysts. Eyes with full-thickness macular holes have a less favorable prognosis, although their natural history may not be as poor as previously thought.

The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, II: characteristics of patients enrolled and not enrolled. COMS Report No. 17.

OBJECTIVES: To describe characteristics of patients evaluated for the Collaborative Ocular Melanoma Study (COMS) randomized clinical trial of iodine 125 brachytherapy for choroidal melanoma by enrollment status, and to compare characteristics of patients enrolled with those of patients with tumors of eligible size who did not enroll in order to assess the extent to which findings from the clinical trial can be generalized to future patients. METHODS: For all patients diagnosed with choroidal melanoma and evaluated for the clinical trial at COMS centers from November 1986 through July 31, 1998, selected data were transmitted to the COMS Coordinating Center, Baltimore, Md, where they were integrated and analyzed. Data included ophthalmic and medical history, examination findings, and visual acuity measurements recorded prior to enrollment; standardized A- and B-scan echographic examination findings; and wide-angle fundus photographs and fluorescein angiograms. RESULTS: Of 8712 patients with choroidal melanoma, 5046 had tumors of eligible size; of these, 2882 (57%) were eligible for enrollment, and 1317 (46% of eligible patients, 26% of patients with tumors of eligible size) enrolled. Most differences between eligible and ineligible patients corresponded to eligibility and exclusion criteria. However, ineligible patients were older and had thicker tumors than eligible patients. Eligible patients who enrolled were slightly older and had larger tumors than those who did not enroll. Nearly half (48%) of enrolled patients had choroidal melanoma with the apex located temporal to the fovea, compared with 40% of eligible patients not enrolled and 29% of ineligible patients. CONCLUSIONS: This trial was designed to yield internally valid treatment comparisons through random assignment to treatment at time of enrollment. Information from this and other studies document that enrolled patients were similar to other patients with choroidal melanoma who were treated with 125I brachytherapy. These findings support the external validity of the trial and applicability of treatment findings to all patients who meet the criteria used to judge eligibility for the trial.

The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, III: initial mortality findings. COMS Report No. 18.

OBJECTIVES: To report initial mortality findings from the Collaborative Ocular Melanoma Study (COMS) randomized clinical trial of iodine 125 brachytherapy vs enucleation for treatment of choroidal melanoma. METHODS: Patients were evaluated for eligibility at 43 participating clinical centers in the United States and Canada. Eligible consenting patients were assigned randomly at the time of enrollment to enucleation or 125I brachytherapy. Patients were examined at specified intervals after enrollment for data collection purposes. Findings presented herein are based on data received by September 30, 2000. Data for each patient were analyzed with the treatment group to which the patient was assigned randomly at the time of enrollment. RESULTS: During the 11(1/2)-year accrual period, 1317 patients enrolled; 660 were assigned randomly to enucleation and 657 to 125I brachytherapy. Only 2 patients in the enucleation arm were found to have been misdiagnosed when histopathology was reviewed centrally. All but 17 patients (1.3%) received the assigned treatment. Adherence to the brachytherapy protocol was excellent, with 91% of patients treated per protocol. Based on time since enrollment, 1072 patients (81%) had been followed for mortality for 5 years and 416 (32%) for 10 years. A total of 364 patients had died: 188 (28%) of 660 patients in the enucleation arm and 176 (27%) of 657 patients in the brachytherapy arm. The unadjusted estimated 5-year survival rates were 81% and 82%, respectively; there was no clinically or statistically significant difference in survival rates overall (P =.48, log-rank test). The adjusted estimated risk ratio for 125I brachytherapy vs enucleation was 0.99 (95% confidence interval [CI], 0.80-1.22). Five-year rates of death with histopathologically confirmed melanoma metastasis were 11% and 9% following enucleation and brachytherapy, respectively; after adjustment, the estimated risk ratio was 0.91 (95% CI, 0.66-1.24). CONCLUSIONS: Mortality rates following 125I brachytherapy did not differ from mortality rates following enucleation for up to 12 years after treatment of patients with choroidal melanoma who enrolled in this COMS trial. The power of the study was sufficient to indicate that neither treatment is likely to increase or decrease mortality rates by as much as 25% relative to the other.

Comparison of transillumination and histologic slide measurements of choroidal melanoma.

OBJECTIVE: To compare transillumination and histologic slide measurements of choroidal melanomas in 479 eyes randomized to enucleation in the Collaborative Ocular Melanoma Study. DESIGN: Transillumination defects were measured during gross examination of enucleated eyes. Tumor basal diameter and height were measured on histologic slides and each tumor was assigned to 1 of 8 distinct shape categories. Comparison of the transillumination and histologic slide measurements revealed 3 categories of difference: underestimation (transillumination measurement more than 4 mm smaller than the histologic slide measurement), overestimation (transillumination measurement more than 4 mm larger than the histologic slide measurement), and agreement within 4 mm. RESULTS: There was good correlation between transillumination and histologic slide estimates of largest basal diameter, particularly when the basal diameter was 16 mm or less. Measurement discrepancies were related to the shape of the tumors but not to the presence of subretinal fluid or fixation. CONCLUSION: Agreement was high between measurements of transillumination defect and histologic sections.

The VF-14. An index of functional impairment in patients with cataract.

OBJECTIVE: To describe the development and the performance of a brief questionnaire designed to measure functional impairment caused by cataract (the VF-14). DESIGN: Observational cross-sectional study. Patients were recruited between July 15 and December 15, 1991. SETTING: Patients were recruited from the practices of 70 ophthalmologists, located in Columbus, Ohio (N = 21), St Louis, Mo (N = 26), and Houston, Tex (N = 23). PATIENTS: Seven hundred sixty-six patients undergoing cataract surgery for the first time. MAIN OUTCOME MEASURES: Preoperative best corrected visual acuity in each eye; scores on the VF-14, a new index of functional impairment in patients with cataract; patient reports of overall trouble and satisfaction with their vision; and scores on the Sickness Impact Profile, a measure of general health status. RESULTS: The VF-14 has high internal consistency (Cronbach's alpha = .85) and correlates more strongly with the overall self-rating of the amount of trouble and satisfaction patients have with their vision than do several measures of visual acuity or the Sickness Impact Profile score. The VF-14 score is moderately correlated with visual acuity in the better eye. CONCLUSIONS: The VF-14 is a reliable and valid measure of functional impairment caused by cataract and provides information not conveyed by visual acuity or a general measure of health status.

Reproducibility and responsiveness of the VF-14. An index of functional impairment in patients with cataracts.

OBJECTIVES: To assess the test-retest reliability and responsiveness of the VF-14, which is an index of functional impairment in patient with cataracts. DESIGN: Observational longitudinal study. Patients were enrolled prior to undergoing their first cataract surgery between July 15 and December 15, 1991, and they were followed up for 1 year after surgery. SETTING: Patients were recruited from 72 ophthalmologists' practices in three US cities. PATIENTS: Five hundred fifty-two patients who had undergone a surgical procedure in only one eye by the 4-month postoperative follow-up (responsiveness analyses) and a subset of these (n = 426) who had not subsequently undergone surgery for the second eye by the 12-month postoperative follow-up (reproducibility analyses). MAIN OUTCOME MEASURES: Two health status measures (the VF-14 and the Sickness Impact Profile, two global measures of a patient's trouble and satisfaction with his or her vision, and best corrected visual acuity in each eye. RESULTS: The VF-14 is highly reproducible, with an intraclass correlation coefficient of .79 when patient-rated criteria are used to define stable patients. The intraclass correlation coefficient was lower (.57 to .71) when various measures of visual acuity were used to define stable patients. The VF-14 is also about three times more responsive to a change in vision than the Sickness Impact Profile, which is a generic health status measure (effect size of approximately 1.00 vs 0.30). Estimates of the responsiveness of the VF-14 and the Sickness Impact Profile were not associated with preoperative visual acuity in the operated on or better eye. Responsiveness of the VF-14, however, was higher in patients with greater self-rated trouble with vision preoperatively. CONCLUSIONS: The VF-14 was reproducible in stable patients during an 8-month period, and it was more responsive to clinically significant changes in vision than was a generic health status measure (ie, the Sickness Impact Profile).