Development and Validation of a Quantitative Measure of Adaptive Behaviors in Women With Pelvic Floor Disorders.

PURPOSE: To establish validity for the Pelvic Floor Disorders Network (PFDN) self-administered Adaptive Behavior Index (ABI) and to assess whether ABI assesses known discordance between severity of pelvic floor symptoms and self-reported bother. METHODS: In addition to the ABI questionnaire, participants in 1 of 6 Pelvic Floor Disorders Network trials completed condition-specific measures of pretreatment symptom severity (including Pelvic Floor Distress Inventory; PFDI) and health-related quality of life (Pelvic Floor Impact Questionnaire; PFIQ). The final survey was developed from an iterative process using subject and expert endorsement, factor analyses, and response distributions. Domains were created using a development cohort (n = 304 women), reliability and validity were established using a validation cohort (n = 596 women), and test-retest reliability was assessed (n = 111 women). RESULTS: Factor analyses supported an 11-item avoidance domain and a 6-item hygiene domain. Cronbach' alphas were 0.88 and 0.68, respectively. Test-retest reliability was 0.84 for both domains. Construct validity was demonstrated in correlations between the ABI domains and baseline PFDI and PFIQ (r values, 0.43-0.79 with all P values <0.0001). Moreover, the ABI accounted for 8% to 26% of unexplained variance between the symptoms severity measure and the impact on health related quality of life. After treatment, avoidance domain scores improved for urinary and fecal incontinence groups and hygiene scores improved for the fecal incontinence group. CONCLUSIONS: The ABI is a reliable and valid measure in women with pelvic floor disorders. Adaptive behaviors account in part for discordance between pelvic floor symptom severity and bother.

Baseline assessment of campus-wide general health status and mental health: Opportunity for tailored suicide prevention and mental health awareness programming.

OBJECTIVE: A campus-wide assessment examined the physical and mental health status of a midsize midwestern public university. PARTICIPANTS: Two thousand and forty-nine students, faculty, and staff on a single college campus were assessed in March-April 2013. METHODS: Participants completed an online survey with sections devoted to demographics, physical and mental health status, and suicide knowledge and experiences. RESULTS: This study captured broad physical and mental health indicators. Students, faculty, and staff in certain demographic groups were more likely to report significant problems associated with mental and physical health. Specifically, women, faculty and staff of color, and nonheterosexual persons reported worse health outcomes. Across 8 mental health indicators, students reported consistently worse mental health than their faculty/staff counterparts. CONCLUSIONS: This paper presents findings from a significant campus-wide physical and mental health surveillance initiative. Results indicate the need for targeted physical and mental health support and intervention among these demographic groups.

What would brain-computer interface users want: opinions and priorities of potential users with spinal cord injury.

OBJECTIVES: To identify perceptions among people with spinal cord injury (SCI) of the priorities for brain-computer interface (BCI) applications and design features along with the time investment and risk acceptable to obtain a BCI. DESIGN: Survey. SETTING: Research registry participants surveyed via telephone and BCI usage study participants surveyed in person before BCI use. PARTICIPANTS: Convenience sample of people with SCI (N=40), consisting of persons from the registry (n=30) and from the BCI study (n=10). Participants were classified as those with low function (n=24) and those with high function (n=16). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Descriptive statistics of functional independence, living situations and support structures, ratings of importance of different task and design features, and acceptable levels of performance, risk, and time investment. RESULTS: BCIs were of interest to 96% of the low-function group. Emergency communication was the top priority task (ranked in the top 2 by 43%). The most important design features were "functions the BCI provides" and "simplicity of BCI setup." Desired performance was 90% accuracy, with standby mode errors no more than once every 4 hours and speeds of more than 20 letters per minute. Dry electrodes were preferred over gel or implanted electrodes (P<.05). Median acceptable setup time was 10 to 20 minutes, satisfying 65% of participants. CONCLUSIONS: People with low functional independence resulting from SCI have a strong interest in BCIs. Advances in speed and setup time will be required for BCIs to meet the desired performance. Creating BCI functions appropriate to the needs of those with SCI will be of ultimate importance for BCI acceptance with this population.

Barriers to and mediators of brain-computer interface user acceptance: focus group findings.

Brain-computer interfaces (BCI) are designed to enable individuals with severe motor impairments such as amyotrophic lateral sclerosis (ALS) to communicate and control their environment. A focus group was conducted with individuals with ALS (n=8) and their caregivers (n=9) to determine the barriers to and mediators of BCI acceptance in this population. Two key categories emerged: personal factors and relational factors. Personal factors, which included physical, physiological and psychological concerns, were less important to participants than relational factors, which included corporeal, technological and social relations with the BCI. The importance of these relational factors was analysed with respect to published literature on actor-network theory (ANT) and disability, and concepts of voicelessness and personhood. Future directions for BCI research are recommended based on the emergent focus group themes. PRACTITIONER SUMMARY: This manuscript explores human factor issues involved in designing and evaluating brain-computer interface (BCI) systems for users with severe motor disabilities. Using participatory research paradigms and qualitative methods, this work draws attention to personal and relational factors that act as barriers to, or mediators of, user acceptance of this technology.

What would brain-computer interface users want? Opinions and priorities of potential users with amyotrophic lateral sclerosis.

Universal design principles advocate inclusion of end users in every design stage, including research and development. Brain-computer interfaces (BCIs) have long been described as potential tools to enable people with amyotrophic lateral sclerosis (ALS) to operate technology without moving. Therefore the objective of the current study is to determine the opinions and priorities of people with ALS regarding BCI design. This information will guide BCIs in development to meet end-user needs. A telephone survey was undertaken of 61 people with ALS from the University of Michigan's Motor Neuron Disease Clinic. With regard to BCI design, participants prioritized accuracy of command identification of at least 90% (satisfying 84% of respondents), speed of operation comparable to at least 15-19 letters per minute (satisfying 72%), and accidental exits from a standby mode not more than once every 2-4 h (satisfying 84%). While 84% of respondents would accept using an electrode cap, 72% were willing to undergo outpatient surgery and 41% to undergo surgery with a short hospital stay in order to obtain a BCI. In conclusion, people with ALS expressed a strong interest in obtaining BCIs, but current BCIs do not yet provide desired BCI performance.

Amyotrophic lateral sclerosis patients' self-reported satisfaction with assistive technology.

INTRODUCTION: Assistive devices are prescribed for amyotrophic lateral sclerosis (ALS) patients with motor deficits, but little is known about their perceived benefit. Therefore, we assessed ALS patients' satisfaction with commonly prescribed devices. METHODS: A telephone survey of 63 ALS patients from a single multidisciplinary clinic was conducted to assess the frequency of use, perceived usefulness, and satisfaction with 33 assistive devices. RESULTS: Of those assistive technologies used "often or always" by ≥ 20% of respondents, arm rails by the toilet, elevated toilet seat, shower seat, shower bars, and slip-on shoes were ranked very highly for both usefulness and satisfaction. The ankle brace for ambulation, transfer board, speaker phone, and electronic seating controls were also ranked highly. The button hook, dressing stick, and long-handled reaching tool received low ratings for both usefulness and satisfaction. CONCLUSIONS: ALS patients reported high usefulness and satisfaction levels with all bathroom adaptive devices and certain low-technology devices.

Lessons learned from a peri-urban needle exchange.

BACKGROUND: Injection drug users continue to be at high risk of HIV and HCV. Research has shown that needle exchange programs (NEP) decrease injection frequency, reduce syringe reuse, and reduce needle sharing, though some results have been mixed. METHODS: This evaluation of a small, peri-urban, legal NEP near Ypsilanti, Michigan describes the operation of the NEP and its clients. It uses interviews conducted with NEP participants between 2003 and 2006, describing the population served by the program, and draws on limited comparisons between matched baseline and follow-up measures as well as aggregate baseline and follow-up comparisons. RESULTS: The HIV/AIDS Resource Center (HARC) Harm Reduction NEP serves a diverse population from a wide geographical area. NEP participants at follow-up reused their syringes significantly fewer times before getting new ones, were significantly less likely to report giving another IDU a previously used syringe, and were more likely to clean their skin with alcohol either before or after injecting than the baseline comparison group. CONCLUSIONS: The limited data presented here suggest that a NEP can be an effective method of harm reduction even in low-volume, non-urban settings and are an important venue for intervention in peri-urban areas.

Contrasting the use of 2 vision-specific quality of life questionnaires in subjects with open-angle glaucoma.

PURPOSE: To compare 2 vision-specific functional status measures to each other and to clinical parameters in the Collaborative Initial Glaucoma Treatment Study (CIGTS). METHODS: CIGTS participants completed the Visual Activities Questionnaire (VAQ) and the National Eye Institute-Visual Function Questionnaire (NEI-VFQ) and were tested for visual field (VF) and visual acuity (VA). In all, 426 subjects contributed the VAQ and NEI-VFQ scores at 54 months. Pearson correlations were used to assess associations. RESULTS: The VAQ subscales (range, 0 to 100) that assessed light-dark adaptation (mean=66.1), glare disability (66.4), and acuity/spatial vision (67.7) indicated vision-related functions that CIGTS participants found most difficult. On the NEI-VFQ, subjects reported high levels of visual functioning, with mean >/=90 (out of 100) on the total score and in 9 of 12 subscales. General vision (mean=82.6) received the lowest subscale score. Two subscales common to both questionnaires were highly correlated: VA (r=0.68) and peripheral vision (r=0.77) (both P<0.0001). Correlations between participants' perceptions and clinical measures of visual function were in the expected direction, but weaker. Stronger associations were found between clinical measures and the NEI-VFQ than the VAQ. Better eye VF and worse eye VA had the highest number of significant correlations with subjects' perceptions of their visual function. Increasing VF loss was associated with a significant decrease in the overall and peripheral vision subscale scores from both questionnaires, and also several other subscales. CONCLUSIONS: CIGTS patients reported excellent visual function on both the NEI-VFQ and VAQ. These findings will help researchers interested in assessing patients' perceptions of their visual function make an informed selection when choosing between the VAQ and the NEI-VFQ.

Patient reported symptoms during an ulcerative colitis flare: a Qualitative Focus Group Study.

BACKGROUND: It has been assumed that the symptoms measured in disease activity indices for ulcerative colitis reflect those symptoms that patients find useful in evaluating the severity of a disease flare. OBJECTIVE: We aimed to identify which symptoms are important to patients and to compare these symptoms with a comprehensive list of commonly measured symptoms to evaluate whether the patient-reported important symptoms are represented in current disease activity indices for ulcerative colitis. METHODS: Qualitative focus group study. RESULTS: Patients in this sample confirmed 15 symptoms but not 11 other symptoms found in common ulcerative colitis activity indices. Patients identified an additional 14 symptoms not included in commonly used ulcerative colitis activity indices, which they believed to be important in evaluating the onset or severity of an ulcerative colitis flare. CONCLUSION: Current indices capture only a portion of the clinical symptoms that are important to patients in an ulcerative colitis flare, and may neither accurately measure nor fully reflect patients' experience of ulcerative colitis. These findings present an opportunity to develop better patient-centered measures of ulcerative colitis.

Risk of sleep apnea in orchestra members.

BACKGROUND: Obstructive sleep apnea (OSA) is a common condition with substantial health consequences. A recent randomized trial found that playing the didgeridoo improved both subjective and objective sleep measures. We undertook a cross-sectional survey of professional orchestra players to test the hypothesis that playing a wind instrument would be associated with a lower risk of OSA. METHODS: An anonymous internet-based survey of professional orchestra members assessed risk of sleep apnea using the Berlin questionnaire. Multivariable logistic regression was used to test the association between playing a wind instrument and having a high risk score on the Berlin questionnaire, both unadjusted and adjusted for age, body mass index, and gender. RESULTS: A total of 1,111 orchestra members responded, including 369 (33%) wind instrument players. Wind players were more often male and had a higher body mass index than non-wind players. Of all musicians, 348 (31%) had a high risk of sleep apnea. Wind players were more likely than non-wind players to be at high risk in unadjusted analysis (Odds ratio=1.47, 95% CI 1.13, 1.91), though this association was not significant in adjusted analysis (Odds ratio=1.12 (0.82, 1.54)). CONCLUSION: Playing a wind instrument was not associated with a lower risk of OSA.

Evaluating clinical change and visual function concerns in drivers and nondrivers with glaucoma.

PURPOSE: To compare drivers and nondrivers, and to describe the specific concerns of drivers, among individuals with glaucoma. METHODS: Six hundred seven patients with newly diagnosed glaucoma treated at 14 clinical centers of the Collaborative Initial Glaucoma Treatment Study were randomly assigned to initial medicine or surgery and were followed up every 6 months. Driving status (drivers versus nondrivers) and patient-reported visual function were determined by the Visual Activities Questionnaire and the National Eye Institute Visual Function Questionnaire. Clinical evaluation included visual field mean deviation (MD) and visual acuity. Statistical comparisons were made using t, chi(2), and exact tests and regression and Rasch analyses. RESULTS: Drivers were more likely than nondrivers to be male, white, married, employed, and more educated and to have higher incomes and fewer comorbidities. More than 50% of drivers reported at least "some" difficulty performing tasks involving glare, whereas 22% reported at least "some" difficulty with tasks requiring peripheral vision. At 54 months, drivers with moderate/severe bilateral visual field loss (VFL) reported greater difficulty with night driving and tasks involving visual search and visual processing speed than drivers with less bilateral VFL (all P<0.05). Although those who remained drivers over follow-up had better MD in both eyes than those who became nondrivers because of eyesight, a number of drivers had marked VFL. CONCLUSIONS: Inquiring about specific difficulties with tasks related to glare, visual processing speed, visual search, and peripheral vision in driving, especially among patients with substantial bilateral visual field damage, will enable physicians to more effectively counsel patients regarding driving.

Identification of symptom domains in ulcerative colitis that occur frequently during flares and are responsive to changes in disease activity.

BACKGROUND: Ulcerative colitis disease activity is determined by measuring symptoms and signs. Our aim was to determine which symptom domains are frequent and responsive to change in the evaluation of disease activity, which are those defined by three criteria: 1) they occur frequently during flares; 2) they improve during effective therapy for ulcerative colitis; and 3) they resolve during remission. METHODS: Twenty-eight symptom domains, 16 from standard indices and 12 novel domains identified by ulcerative colitis patient focus groups, were evaluated. Sixty subjects with ulcerative colitis were surveyed, rating each symptom on the three criteria with a 100 mm Visual Analogue Scale. Frequent and responsive symptoms were defined a priori as those whose median Visual Analogue Scale rating for all 3 criteria was significantly greater than 50. RESULTS: Thirteen of the 28 symptom domains were identified as both frequent in ulcerative colitis flares and responsive to changes in disease activity. Seven of these 13 symptom domains were novel symptoms derived from ulcerative colitis patient focus groups including stool mucus, tenesmus, fatigue, rapid postprandial bowel movements, and inability to differentiate liquid or gas from solid stool when rectal urgency occurs. Ten of the 16 symptom domains from standard indices were either infrequent or unresponsive to changes in disease activity. CONCLUSION: Only some of the symptoms of ulcerative colitis that are important to patients are included in standard indices, and several symptoms currently measured are not frequent or responsive to change in ulcerative colitis patients. Development of survey measures of these symptom domains could significantly improve the assessment of disease activity in ulcerative colitis.

Enhancing participation of older women in surgical trials.

BACKGROUND: Older participants are often excluded from clinical trials, precluding a representative sample. STUDY DESIGN: Using qualitative and quantitative methods, we examined recruitment and retention of older women with pelvic organ prolapse in two surgical trials: the randomized Colpopexy And Urinary Reduction Efforts (CARE) study and the Longitudinal Pelvic Symptoms and Patient Satisfaction After Colpocleisis cohort study. Using focus groups, we developed a questionnaire addressing factors facilitating and impeding the recruitment and retention of older study participants and administered it to research staff. Enrollment-to-surgery ratios, missed visit rates, and dropout rates for older and younger participants were compared using Fisher's exact test, with cut-points of 70 and 80 years for the CARE and Colpocleisis studies, respectively. RESULTS: Questionnaires were completed by 23 physician investigators and 11 nurses or coordinators (92% response rate). Respondents indicated it was more difficult to recruit older research participants (32%), obtain informed consent (56%), and retain participants to study completion (50%). Challenges to recruitment included caregiver involvement in the decision to participate and participant comorbidities. Perceived barriers to retention were transportation, caregiver availability, and participant fatigue. Data quality was challenged by sensory and cognitive impairment, resulting in a change from telephone interviews to in-person visits in the Colpocleisis study. Older participants did not have higher dropout rates than younger participants. There were no differences in missed in-person visits or telephone interview rates between age groups. CONCLUSIONS: Strategies, albeit unstudied, could assist investigators in planning surgical trials that successfully enroll and retain older women.

Optimism in women undergoing abdominal sacrocolpopexy for pelvic organ prolapse.

BACKGROUND: Although studies suggest that optimism can predict health outcomes, the relationship has not been tested in women with pelvic organ prolapse (POP). This study sought to explore the relationship between optimism, prolapse severity, and symptoms before operation; and examine whether optimism predicts postsurgical functional status, treatment satisfaction, and treatment success. STUDY DESIGN: Data from the randomized Colpopexy and Urinary Reduction Efforts (CARE) study, in which stress continent women undergoing sacrocolpopexy to repair stage II to IV POP completed a baseline assessment of optimism and validated symptom and quality-of-life measures at baseline and 24 months. Relationships between optimism and demographics, clinical status, and functional and quality-of-life outcomes were assessed. RESULTS: Of 322 Colpopexy and Urinary Reduction Efforts study participants, 305 (94.7%) completed 24-month followup interviews. At baseline, there were no notable differences in optimism with respect to POP stage or history of earlier operations for prolapse or urinary incontinence. At baseline, women with greater optimism reported markedly better physical and mental functioning (p

Sexual function before and after sacrocolpopexy for pelvic organ prolapse.

OBJECTIVE: The objective of the study was to describe sexual function before and after sacrocolpopexy. STUDY DESIGN: In the Colpopexy and Urinary Reduction Efforts trial, sexual function was assessed in 224 women with sexual partners before and 1 year after surgery using validated questionnaires. RESULTS: After surgery, significantly fewer women reported sexual interference from "pelvic or vaginal symptoms" (32.5% 1 year after surgery vs 7.8% prior to surgery); fear of incontinence (10.7% vs 3.3%); vaginal bulging (47.3% vs 4.6%); or pain (39.9% vs 21.6%). The proportion of women with infrequent sexual desire (32%) did not change. More women were sexually active 1 year after surgery (171, 76.3%) than before surgery (148, 66.1%). The 11 women (7.4%) who became sexually inactive were more likely than sexually active women to report infrequent sexual desire (70.0% vs 22.1%, P < .001). The addition of Burch colposuspension did not have an impact on postoperative sexual function. CONCLUSION: After sacrocolpopexy, most women reported improvements in pelvic floor symptoms that previously interfered with sexual function. The addition of Burch colposuspension did not adversely influence sexual function.

Bowel symptoms in women 1 year after sacrocolpopexy.

OBJECTIVE: The objective of the study was to evaluate changes in bowel symptoms after sacrocolpopexy. STUDY DESIGN: This was a prospectively planned, ancillary analysis of the Colpopexy and Urinary Reduction Efforts study, a randomized trial of sacrocolpopexy with or without Burch colposuspension in stress continent women with stages II-IV prolapse. In addition to sacrocolpopexy (+/- Burch), subjects underwent posterior vaginal or perineal procedures (PR) at each surgeon's discretion. The preoperative and 1 year postoperative Colorectal-anal Distress Inventory (CRADI) scores were compared within and between groups using Wilcoxon signed-rank and rank-sum tests, respectively. RESULTS: The sacrocolpopexy + PR group (n = 87) had more baseline obstructive colorectal symptoms (higher CRADI and CRADI-obstructive scores: P = .04 and < .01, respectively) than the sacrocolpopexy alone group (n = 211). CRADI total, obstructive, and pain/irritation scores significantly improved in both groups (all P < .01). Most bothersome symptoms resolved after surgery in both groups. CONCLUSION: Most bowel symptoms improve in women with moderate to severe pelvic organ prolapse after sacrocolpopexy.

Spanish language translation of pelvic floor disorders instruments.

The purpose of the study is to translate existing measures of pelvic symptoms and quality of life from English into Spanish, facilitating research participation of Hispanic/Latina women. The forward-backward translation protocol was applied then adjudicated by a concordance committee. The measures included the Pelvic Floor Distress Inventory (PFDI), Pelvic Floor Impact Questionnaire (PFIQ), Medical, Epidemiological, and Social Aspects of Aging (MESA) Questionnaire, Hunskaar Severity Measure, Fecal Incontinence Severity Index and modified Manchester Questionnaire, Pelvic Organ Prolapse/Urinary Incontinence Sexual Functioning Questionnaire (PISQ), and the Life Orientation Test (LOT). English and Spanish versions were administered to 50 Hispanic/Latina women with pelvic symptoms. Kappa correlations of items and correlation coefficients for scales were computed. Psychometric testing for translations demonstrated good (0.80-0.89), very good (0.90-0.95), or excellent (>0.95) correlations for primary scales of the PFDI, PFIQ, MESA, Hunskaar, PISQ, and LOT. Strict translation techniques and testing yielded valid Spanish translations of instruments assessing pelvic symptoms/functional life impact in women with pelvic floor disorders.

Depression and mood indicators in newly diagnosed glaucoma patients.

PURPOSE: To assess depression and mood indicators in subjects newly diagnosed with chronic open-angle glaucoma. DESIGN: Cross-sectional study of data from a randomized clinical trial. METHODS: Newly-diagnosed glaucoma patients enrolled in the Collaborative Initial Glaucoma Treatment Study (CIGTS) responded at baseline to quality-of-life (QOL) telephone interviews. We studied responses to the 33-item Visual Activities Questionnaire (VAQ), six items from a disease-specific Health Perceptions Index (HPI), and eight questions from the Center for Epidemiological Studies Depression Scale (CES-D). We correlated the responses to the HPI and the CES-D with visual acuity (VA) and CIGTS visual field (VF) as well as to the responses to the VAQ. RESULTS: VAQ score was correlated (P < .01 in all cases) with better VA (P = -0.181), better VF (P = 0.139), worse VA (P = -0.128), and worse VF (P = .120). There were also correlations (P ranging from .24 to .38, all P values < or = .001) between patients' perception of their vision (total VAQ score) and each item on the HPI and CES-D. None of the clinical vision measures were associated with any of the CES-D items. The strongest correlation between a clinical measure and an item from the HPI was between worse VF and worry about the possibility of blindness (P = -0.114, P = .005). The odds ratio of reporting mood indicators and symptoms of depression increased with patients' perceptions of worsening visual function but not worsening VA or VF. CONCLUSIONS: In these newly diagnosed glaucoma patients, symptoms of depression and altered mood were related to worse self-reported visual function as assessed by the VAQ, but not to monocular clinical measures of visual function.

Fear of blindness in the Collaborative Initial Glaucoma Treatment Study: patterns and correlates over time.

PURPOSE: The objective of this study was to describe the prevalence of fear of blindness (FOB) and the factors associated with FOB during 5 years of follow-up in the Collaborative Initial Glaucoma Treatment Study. DESIGN: Randomized controlled clinical trial. PARTICIPANTS: A total of 607 newly diagnosed patients with open-angle glaucoma were recruited from 14 clinical centers in the United States. METHODS: Patients were assigned randomly either to initial medical therapy or initial trabeculectomy. Study participants received clinical examinations and quality-of-life (QOL) evaluations at baseline and 6-month intervals. The QOL questionnaire was administered by trained telephone interviewers at a centralized interviewing center. MAIN OUTCOME MEASURES: The QOL questionnaire included an assessment of FOB, measures of vision-related functioning, and measures of general physical and psychosocial well being. Ordinal logistic regression analyses were used to assess clinical and QOL measures associated with FOB over time. RESULTS: After being told about the glaucoma diagnosis but before randomization, 34% of patients reported at least a moderate amount of FOB. This percent dropped to 11% at 5 years. In multivariable ordinal logistic regression models, younger age, being white, and having less education and a lower income were associated with increased FOB (all P<0.05). At the 36-month follow-up, visual field progression was associated significantly with increased FOB (P = 0.006); visual acuity loss, although related to increased FOB, did not achieve statistical significance (P = 0.327). Self-reported visual function measures explained more of the variation in FOB over time than did demographic, clinical, or physical or psychosocial measures. Initial treatment assignment (medicine or surgery) was not associated with FOB. The most significant correlate over time with FOB was the perceived impact on an individual's ability to perform visual tasks. CONCLUSIONS: More attention to reducing glaucoma patients' FOB at diagnosis and over time is warranted. Fear of blindness over time is related more to how much an individual is bothered by their inability to perform visual tasks than to their monocular visual acuity or visual field assessments.

Cataract extraction in the collaborative initial glaucoma treatment study: incidence, risk factors, and the effect of cataract progression and extraction on clinical and quality-of-life outcomes.

OBJECTIVES: To study the incidence of and predictors for cataract extraction (CE) in patients with newly diagnosed glaucoma, the impact of CE on visual function, and changes in the time around CE. METHODS: Patients were randomized to medical or surgical treatments for glaucoma at 14 centers and followed up for a median of 7.7 years. Vision-specific quality of life (VS-QOL) data were collected by telephone interview during follow-up of 607 patients randomized to medical or surgical treatments for glaucoma. The occurrence of CE was the signal event. Risk factors were evaluated using survival analyses; changes from before to after CE were evaluated by paired t tests; and trends were estimated by loess regression. RESULTS: During follow-up of 607 patients, CE took place in 99 study eyes. Initial surgery, older age, a more negative spherical equivalent, and a diagnosis of pseudoexfoliative glaucoma conferred a higher risk of CE. Visual field testing before and after CE showed the mean deviation improved but the pattern standard deviation worsened. The VS-QOL improved on most subscales. CONCLUSIONS: Initial surgery places a patient with glaucoma at a higher risk of CE. The impact of CE on visual field indexes is mixed-the mean deviation improved but the pattern standard deviation worsened. Most, but not all, VS-QOL subscales were responsive to worsening of cataract prior to and acute improvement in vision after CE.