Using a discrete choice experiment to value the QLU-C10D: feasibility and sensitivity to presentation format.

PURPOSE: To assess the feasibility of using a discrete choice experiment (DCE) to value health states within the QLU-C10D, a utility instrument derived from the QLQ-C30, and to assess clarity, difficulty, and respondent preference between two presentation formats. METHODS: We ran a DCE valuation task in an online panel (N = 430). Respondents answered 16 choice pairs; in half of these, differences between dimensions were highlighted, and in the remainder, common dimensions were described in text and differing attributes were tabulated. To simplify the cognitive task, only four of the QLU-C10D's ten dimensions differed per choice set. We assessed difficulty and clarity of the valuation task with Likert-type scales, and respondents were asked which format they preferred. We analysed the DCE data by format with a conditional logit model and used Chi-squared tests to compare other responses by format. Semi-structured telephone interviews (N = 8) explored respondents' cognitive approaches to the valuation task. RESULTS: Four hundred and forty-nine individuals were recruited, 430 completed at least one choice set, and 422/449 (94 %) completed all 16 choice sets. Interviews revealed that respondents found ten domains difficult but manageable, many adopting simplifying heuristics. Results for clarity and difficulty were identical between formats, but the "highlight" format was preferred by 68 % of respondents. Conditional logit parameter estimates were monotonic within domains, suggesting respondents were able to complete the DCE sensibly, yielding valid results. CONCLUSION: A DCE valuation task in which only four of the QLU-C10D's ten dimensions differed in any choice set is feasible for deriving utility weights for the QLU-C10D.

Low rate of cetuximab hypersensitivity reactions in Northeast Tennessee: An Appalachian effect?

PURPOSE: Cetuximab is a monoclonal antibody with a known risk of hypersensitivity reactions. Early studies showed hypersensitivity reaction rates of 3%, but there appears to be a higher incidence in the southeastern United States. To confirm the findings from nearby institutions that cetuximab-associated hypersensitivity reactions occur in approximately 20% of patients in the southeastern United States. METHODS: A retrospective chart review was conducted at Johnson City Medical Center in Johnson City, Tennessee. Each patient's first infusion was analyzed for hypersensitivity reaction, as well as for demographic information such as allergy and smoking history, pre-medications, and malignancy type. RESULTS: Data from the first infusion of cetuximab were collected for a total of 71 patients with various malignancies. The overall rate of grade 3 or higher hypersensitivity reaction was 1.4%, and total rate of hypersensitivity reaction was 8.5%. These findings more closely correlate to the early clinical trials and package insert. Both severe (p = 0.001) and any-grade (p = 0.002) hypersensitivity reaction occurred less frequently in one Southeastern Appalachian medical center compared to academic medical centers directly to the east and west. CONCLUSIONS: Patients in southern Appalachia may be less likely to develop cetuximab hypersensitivity reactions compared to surrounding areas in the Southeastern U.S. These results lend support to the theory that exposure to lonestar ticks (Amblyomma americanum) may be responsible for the development of IgE antibodies to cetuximab that cause hypersensitivity reactions. The development of quick and reliable bedside predictors of cetuximab hypersensitivity reactions may aid clinicians considering the use of cetuximab.

Survival gains needed to offset persistent adverse treatment effects in localised prostate cancer.

BACKGROUND: Men diagnosed with localised prostate cancer (LPC) face difficult choices between treatment options that can cause persistent problems with sexual, urinary and bowel function. Controlled trial evidence about the survival benefits of the full range of treatment alternatives is limited, and patients' views on the survival gains that might justify these problems have not been quantified. METHODS: A discrete choice experiment (DCE) was administered in a random subsample (n=357, stratified by treatment) of a population-based sample (n=1381) of men, recurrence-free 3 years after diagnosis of LPC, and 65 age-matched controls (without prostate cancer). Survival gains needed to justify persistent problems were estimated by substituting side effect and survival parameters from the DCE into an equation for compensating variation (adapted from welfare economics). RESULTS: Median (2.5, 97.5 centiles) survival benefits needed to justify severe erectile dysfunction and severe loss of libido were 4.0 (3.4, 4.6) and 5.0 (4.9, 5.2) months. These problems were common, particularly after androgen deprivation therapy (ADT): 40 and 41% overall (n=1381) and 88 and 78% in the ADT group (n=33). Urinary leakage (most prevalent after radical prostatectomy (n=839, mild 41%, severe 18%)) needed 4.2 (4.1, 4.3) and 27.7 (26.9, 28.5) months survival benefit, respectively. Mild bowel problems (most prevalent (30%) after external beam radiotherapy (n=106)) needed 6.2 (6.1, 6.4) months survival benefit. CONCLUSION: Emerging evidence about survival benefits can be assessed against these patient-based benchmarks. Considerable variation in trade-offs among individuals underlines the need to inform patients of long-term consequences and incorporate patient preferences into treatment decisions.

The relationship of respiratory and cardiovascular hospital admissions to the southern California wildfires of 2003.

OBJECTIVE: There is limited information on the public health impact of wildfires. The relationship of cardiorespiratory hospital admissions (n = 40 856) to wildfire-related particulate matter (PM(2.5)) during catastrophic wildfires in southern California in October 2003 was evaluated. METHODS: Zip code level PM(2.5) concentrations were estimated using spatial interpolations from measured PM(2.5), light extinction, meteorological conditions, and smoke information from MODIS satellite images at 250 m resolution. Generalised estimating equations for Poisson data were used to assess the relationship between daily admissions and PM(2.5), adjusted for weather, fungal spores (associated with asthma), weekend, zip code-level population and sociodemographics. RESULTS: Associations of 2-day average PM(2.5) with respiratory admissions were stronger during than before or after the fires. Average increases of 70 microg/m(3) PM(2.5) during heavy smoke conditions compared with PM(2.5) in the pre-wildfire period were associated with 34% increases in asthma admissions. The strongest wildfire-related PM(2.5) associations were for people ages 65-99 years (10.1% increase per 10 microg/m(3) PM(2.5), 95% CI 3.0% to 17.8%) and ages 0-4 years (8.3%, 95% CI 2.2% to 14.9%) followed by ages 20-64 years (4.1%, 95% CI -0.5% to 9.0%). There were no PM(2.5)-asthma associations in children ages 5-18 years, although their admission rates significantly increased after the fires. Per 10 microg/m(3) wildfire-related PM(2.5), acute bronchitis admissions across all ages increased by 9.6% (95% CI 1.8% to 17.9%), chronic obstructive pulmonary disease admissions for ages 20-64 years by 6.9% (95% CI 0.9% to 13.1%), and pneumonia admissions for ages 5-18 years by 6.4% (95% CI -1.0% to 14.2%). Acute bronchitis and pneumonia admissions also increased after the fires. There was limited evidence of a small impact of wildfire-related PM(2.5) on cardiovascular admissions. CONCLUSIONS: Wildfire-related PM(2.5) led to increased respiratory hospital admissions, especially asthma, suggesting that better preventive measures are required to reduce morbidity among vulnerable populations.

Symptoms in pediatric asthmatics and air pollution: differences in effects by symptom severity, anti-inflammatory medication use and particulate averaging time.

Experimental research in humans and animals points to the importance of adverse respiratory effects from short-term particle exposures and to the importance of proinflammatory effects of air pollutants, particularly O(subscript)3. However, particle averaging time has not been subjected to direct scientific evaluation, and there is a lack of epidemiological research examining both this issue and whether modification of air pollutant effects occurs with differences in asthma severity and anti-inflammatory medication use. The present study examined the relationship of adverse asthma symptoms (bothersome or interfered with daily activities or sleep) to O(3) and particles (less than or equal to)10 micrometer (PM10) in a Southern California community in the air inversion zone (1200-2100 ft) with high O(3) and low PM (R = 0.3). A panel of 25 asthmatics 9-17 years of age were followed daily, August through October 1995 (n = 1,759 person-days excluding one subject without symptoms). Exposures included stationary outdoor hourly PM10 (highest 24-hr mean, 54 microgram/m(3), versus median of 1-hr maximums, 56 microgram/m(3) and O(3) (mean of 1-hr maximums, 90 ppb, 5 days (greater than or equal to)120 ppb). Longitudinal regression analyses utilized the generalized estimating equations (GEE) model controlling for autocorrelation, day of week, outdoor fungi, and weather. Asthma symptoms were significantly associated with both outdoor O(3) and PM(10) in single pollutant- and co-regressions, with 1-hr and 8-hr maximum PM(10) having larger effects than the 24-hr mean. Subgroup analyses showed effects of current day PM(10) maximums were strongest in 10 more frequently symptomatic (MS) children: the odds ratios (ORs) for adverse symptoms from 90th percentile increases were 2.24 [95% confidence interval (CI), 1.46-3.46] for 1-hr PM10 (47 microgram/m(3); 1.82 (CI, 1.18-2.81) for 8-hr PM10 (36 microgram/m(3); and 1.50 (CI, 0.80-2.80) for 24-hr PM10 (25 microgram/m(3). Subgroup analyses also showed the effect of current day O(subscript)3 was strongest in 14 less frequently symptomatic (LS) children: the ORs were 2.15 (CI, 1.04-4.44) for 1-hr O(3) (58 ppb) and 1.92 (CI, 0.97-3.80) for 8-hr O(3) (46 ppb). Effects of 24-hr PM10 were seen in both groups, particularly with 5-day moving averages (ORs were 1.95 for MS and 4. 03 for LS; p(less than or equal to)0.05). The largest effects were in 7 LS children not on anti-inflammatory medications [5-day, 8-hr PM10, 9.66 (CI, 2.80-33.21); current day, 1-hr O(3), 4.14 (CI, 1.71-11.85)]. Results suggest that examination of short-term particle excursions, medication use, and symptom severity in longitudinal studies of asthma yields sensitive measures of adverse respiratory effects of air pollution.

The effect of outdoor fungal spore concentrations on daily asthma severity.

The relationship between day-to-day changes in asthma severity and combined exposures to community air pollutants and aeroallergens remains to be clearly defined. We examined the effects of outdoor air pollutants, fungi, and pollen on asthma. Twenty-two asthmatics ages 9-46 years were followed for 8 weeks (9 May-3 July 1994) in a semirural Southern California community around the air inversion base elevation (1,200 ft). Daily diary responses included asthma symptom severity (6 levels), morning and evening peak expiratory flow rates (PEFR), and as-needed beta-agonist inhaler use. Exposures included 24-hr outdoor concentrations of fungi, pollen, and particulate matter with a diameter < 10 microns (PM10; maximum = 51 micrograms/m3) and 12-hour day-time personal ozone (O3) measurements (90th percentile = 38 ppb). Random effects longitudinal regression models controlled for autocorrelation and weather. Higher temperatures were strongly protective, probably due to air conditioning use and diminished indoor allergens during hot, dry periods. Controlling for weather, total fungal spore concentrations were associated with all outcomes: per minimum to 90th percentile increase of nearly 4,000 spores/m3, asthma symptom scores increased 0.36 (95% CI, 0.16-0.56), inhaler use increased 0.33 puffs (95% CI, -0.02-0.69), and evening PEFR decreased 12.1 l/min (95% CI, -1.8-22.3). These associations were greatly enhanced by examining certain fungal types (e.g., Alternaria, basidiospores, and hyphal fragments) and stratifying on 16 asthmatics allergic to tested deuteromycete fungi. There were no significant associations to low levels of pollen or O3, but inhaler use was associated with PM10 (0.15 inhaler puffs/10 micrograms/m3; p < 0.02). These findings suggest that exposure to fungal spores can adversely effect the daily respiratory status of some asthmatics.

Penetrating keratoplasty for pseudophakic corneal edema with exchange of intraocular lenses.

We studied one eye in each of 25 consecutive patients with pseudophakic corneal edema. Each patient underwent a penetrating keratoplasty with exchange of intraocular lenses and was followed up for 12 to 38 months (mean, 18.7 months). The corneal graft remained clear in 22 (88%) eyes, but only eight eyes (32%) had acuity of 20/40 or better; nine eyes (36%) manifested cystoid macular edema, and six eyes (24%) had degenerative maculopathy. Elevated intraocular pressure was present in 12 eyes after surgery, with three eyes manifesting visual field loss; in all eyes the condition was controlled medically. Peripheral anterior synechiae appeared postoperatively in two eyes. We now treat severe cases of pseudophakic corneal edema with a penetrating keratoplasty, meticulous anterior vitrectomy, gonioplasty, iridoplasty, and exchange of intraocular lenses, employing a flexible-loop anterior chamber lens or a posterior chamber lens sutured to the iris.

Assessment of visual acuity via a telephone interview.

We compared the visual acuity of 89 patients obtained via a telephone interview with visual acuity elicited from the same patients in an ophthalmologist's office. Agreement within one line of vision between the telephone interview, in which patients used a modified Rosenbaum near card with attached patch, and the clinic near vision test was observed in 91% of eyes, while agreement within one line of vision between the telephone interview and clinic distance vision test was found in 86% of eyes. We conclude that testing visual acuity via a telephone interview is a potentially useful approach to assessment of visual acuity and prevalence of visual impairment in the larger population.

Refractive keratoplasty in monkeys using intracorneal lenses of various refractive indexes.

The refractive power of the cornea can be altered with an intracorneal lens when it is inserted within a freehand lamellar-pocket incision. The effectiveness of the implant in altering the refractive power of the cornea depends on the refractive index of the intracorneal lens, since little change in the anterior corneal curvature occurs. Thirteen nonhuman primate eyes received intracorneal lenses made of synthetic polymers with refractive indexes ranging from 1.3686 to 1.633. The lidofilcon-B hydrogel (refractive index, 1.3686) lenses created no significant alteration in the refractive power of the cornea. The polymethylmethacrylate (refractive index, 1.4900D) and polysulfone (refractive index, 1.633) lenses created a predictable and significant alteration of corneal power that increased with each implant with a successively higher refractive index. The polymethylmethacrylate lens created a refractive alteration that was approximately 31% of the lens power in air. The polysulfone lens created a corneal power alteration that was approximately 40% of the lens power in air.

Outcomes of cataract surgery. Improvement in visual acuity and subjective visual function after surgery in the first, second, and both eyes.

OBJECTIVE: No previous study documents improvement in visual acuity and subjective visual function associated with cataract surgery in the first eye, second eye, and both eyes. Measurement of subjective aspects of visual function and quality of life provides information that cannot be obtained with simple measurement of Snellen visual acuity. METHODS: From 76 ophthalmology practices in three cities, patients undergoing cataract extraction with intraocular lens implantation (n = 613) and comparison patients (n = 408) were enrolled in a prospective study. Questionnaires elicited visual function information before and after surgery, and visual acuity was obtained from the ophthalmologic record. RESULTS: Among patients with cataract and no other eye disease, baseline subjective visual function before surgery in the second eye was better than that before surgery in the first eye. Improvement in subjective visual function was approximately equal postoperatively in first and second eyes. Improvement in subjective function in both eyes postoperatively was significantly greater than that after surgery in the first eye or second eye alone. No statistically significant difference across surgical groups in the proportion of patients demonstrating improvement in visual acuity was observed. CONCLUSION: Patients who underwent surgery in both eyes reported greater improvement in subjective visual function than did those who underwent surgery in one eye. Thus, there seems to be a benefit associated with restoring binocular vision in this population. These findings support the policy recommendation that cataract surgery in both eyes remains the appropriate treatment for patients with bilateral, cataract-induced visual impairment.

National outcomes of cataract extraction. Endophthalmitis following inpatient surgery.

We analyzed the likelihood of rehospitalization for endophthalmitis in 338,141 Medicare beneficiaries over age 65 years who were admitted to US hospitals for cataract extraction in 1984. This cohort represents approximately one half of all persons who underwent cataract extraction under the Medicare program in 1984. Extracapsular extraction was performed in 195,587 (58%) of cases, intracapsular cataract extraction in 99,971 (30%), and phacoemulsification in 28,474 (8%). The risk of rehospitalization for endophthalmitis in the year following surgery was 0.17% for intracapsular cataract extraction compared with 0.12% for extracapsular extraction or phacoemulsification (P less than .002). The risk of endophthalmitis at 1 month was higher for intracapsular cataract extraction than for extracapsular extraction or phacoemulsification (0.11% vs 0.085%), although the difference did not reach statistical significance. Cataract surgery accompanied by anterior vitrectomy increased the 1-month risk of rehospitalization for endophthalmitis to 0.41%, more than a four-fold increase over that for cataract surgery alone (0.09%; P less than .05). The rates of endophthalmitis at 1 year were 0.58% and 0.13%, respectively, for cataract surgery with anterior vitrectomy and cataract surgery alone (P less than .0001). No significant differences in the rate of rehospitalization for endophthalmitis were observed based on the use of an intraocular lens, age, or race. Endophthalmitis within 1 year of surgery was 1.2 times more frequent in men than in women (0.16% vs 0.13%; P = .03). Overall, the likelihood of postoperative endophthalmitis from a national sample is consistent with case series previously reported.

Atherosclerotic disease in patients undergoing cataract extraction. A nationwide case-control study. The Cataract Patient Outcomes Research Team.

OBJECTIVE: To evaluate the association between cataract extraction and atherosclerosis and its complications. DESIGN: A nationwide case-control study. SETTING AND PARTICIPANTS: Using a 5% random sample of all Medicare beneficiaries, we analyzed Medicare claims data on 60803 persons 65 years of age and older who underwent cataract extraction in 1986 or 1987 and a control group of 63765 persons matched to the cases for age, race, sex, ZIP code, and reason for Medicare entitlement. MAIN OUTCOME MEASURE: Atherosclerosis and atherosclerosis-related disease and procedures were defined by International Classification of Diseases, Ninth Revision, Clinical Modification, codes or by Health Care Financing Administration Common Procedure Classification System (Current Procedural Terminology) codes. The strength of evidence for atherosclerotic disease was categorized on the basis of the types of bills in the Medicare claims file. RESULTS: Odds of atherosclerosis-related morbidity and procedures were higher for cases than for controls. The association decreased with patient age and was strongest in beneficiaries aged 65 to 69 years (odds ratio, 1.30; 95% confidence interval, 1.13-1.48). CONCLUSION: Our findings suggest that there is a weak association between a visually significant cataract requiring surgery and atherosclerosis in the younger elderly.

Cystic duct remnant fistulization to the gastrointestinal tract.

Cystic duct remnant (CDR)-enteric fistulization is a rare entity, with only four recorded cases in the literature. CDRs can be found in at least 30% of patients after cholecystectomy and have been reported in as many as 83% of these patients. Calculous obstruction of the CDR or the common bile duct in a patient with a CDR must be present for fistulization to occur. Patients with a CDR-enteric fistula will have biliary tract symptoms after cholecystectomy and may have biliary sepsis. The septic episode or cholangitis may and can resolve when the CDR decompresses through the fistula. In a patient with persistent biliary tract symptoms, CDR should be considered as a possible cause, and common bile duct stones are often associated with CDRs. Signs of systemic infection in patients with biliary symptoms after cholecystectomy may indicate CDR fistulization. If a CDR is suspected, endoscopic retrograde cholangiopancreatography is the diagnostic and potentially therapeutic test of choice. If the patient cannot be successfully treated with endoscopic retrograde cholangiopancreatography or has recurrent symptoms, operative therapy is indicated, including division of the fistula, excision of the CDR, and common bile duct exploration. There may be an increase in the number of complications associated with CDRs, considering the increasing frequency of laparoscopic cholecystectomy resulting in more lengthy CDRs.

Simple ligation vs stump inversion in appendectomy.

The records of 886 patients who had appendectomy performed by the same surgeons within a five-year period were used to contrast appendiceal stump inversion vs simple ligation. Our analysis contrasted inversion vs simple ligation techniques as related to postoperative complications, hospital stay, and pathologic diagnosis. Adhesions requiring repeated operation to relieve bowel obstruction occurred in five of 87 patients with acute gangrenous appendicitis treated by inversion. Of 106 patients with acute gangrenous appendicitis treated with simple ligation, postoperative obstruction developed in none. No other statistically significant differences existed between the two techniques. These data suggest that simple ligation is at least as good as and probably better than inversion of the appendiceal stump.

National five-year mortality after inpatient cataract extraction.

We assessed the five-year mortality in all United States Medicare beneficiaries aged 65 to 79 years who underwent inpatient cataract extraction in 1984. The risk of dying within five years after cataract extraction was compared to the five-year mortality risk of the same aged persons in the United States population. Patients with cataracts who were younger than 75 years had significantly higher age-specific rates of mortality than would be predicted from United States life tables (P less than .001). For example, at the age of 65 years, patients with cataracts had 1.34 times the risk of the United States population (95% confidence interval = 1.29 to 1.41). This risk progressively declined until the age of 75 years, at which age there is little difference between the patients with cataracts and the United States population, except for the oldest women with cataracts (at the age of 79 years, relative risk = .90; 95% confidence interval = .82 to .99). Although selection factors may account for the excess mortality observed among these individuals, these data do support previous analyses that suggest an association between senile cataract and increased risk of mortality.

Incidence of acute angle-closure glaucoma after pharmacologic mydriasis.

PURPOSE: To study the incidence of acute angle-closure glaucoma secondary to pupillary dilation and to identify screening methods for detecting angles at risk of occlusion. METHODS: We studied 5,308 respondents to the Baltimore Eye Survey, a cross-sectional, population-based survey conducted in a multiracial urban community. We measured incidence of acute angle-closure glaucoma after pharmacologic mydriasis and the specificity and sensitivity associated with three screening criteria in identifying those with potentially occludable angles. The screening factors were presence of shallow anterior chamber on penlight examination, history of glaucoma, and blindness. RESULTS: Of the 4,870 subjects whose eyes were dilated on screening examination, none developed acute angle-closure glaucoma. However, 38 patients of the 1,770 who were referred for definitive eye examination were judged to have occludable angles on the basis of gonioscopic methods. Of note, subjects aged 70 years and more were three times more likely to have occludable angles than those aged 40 to 69 years (P < .004) In 14 black subjects with occludable angles, six were detected by history of glaucoma and not by shallow anterior chamber configuration; alternatively, in 24 white subjects, 11 (46%) were detected on the basis of shallow anterior chambers (Fisher's exact test, P = .014). When the three screening factors were considered alone and in combination, the most effective combination for predicting a potentially occludable angle was to use shallow anterior chamber on penlight examination and history of glaucoma. These criteria provide 60.5% sensitivity and 93.3% specificity. CONCLUSION: If screening is performed accurately and the results are negative, the risk of dilating a potentially occludable angle was less than one in 333 subjects (negative predictive value, 0.997) in this population.

Effect of time zone and game time changes on team performance: National Football League.

To determine the effect of time zone and game time changes on NFL team performance, win-loss records from 1978-1987 were analyzed. Twenty-seven NFL teams were grouped by time zone and possible anti-jet lag adjustments. Among all intra-time zone rivals, home teams won 56.6%, away teams won 43.8%, for a home vs away winning percentage change of -12.8% (P < 0.001). West teams (N = 5) displayed fluctuations in home vs away team performance in association with trans-meridian travel. The change in winning percentage was found to be 0.0% vs West teams, -14.1% vs Central teams (N = 8) (P < 0.05), -16.3% vs East (N = 14) (P < 0.05) for West teams (N = 4) flying about 42 h pregame and +2.3% vs East for the one West team advancing practices 3-4 h to match East coast game time in addition to 48 h pregame flights. For night games within the same time zone, home vs away team winning percentage changed -23.8% (P < 0.01). West teams displayed uniformly high home winning percentages (75.0% and 68.4%) when playing Central and East teams, respectively, with little or no fall in away winning percentages (67.7% and 68.8%). For day games, a 3-h phase advance may decrease West coast team performance. In one small subset, anti-jet lag adjustments appeared to eliminate the expected decrement in performance. For night games, West coast teams, whether home or away, appear to be at a distinct advantage over East and Central teams.

A humeral replacement prosthesis for the elbow: results in ten elbows.

A stainless-steel or titanium prosthetic replacement for the trochlea and capitellum was developed and used in ten elbows, five with post-traumatic lesions, three with rheumatoid arthritis, and two with ankylosis secondary to hemophilia. After followups of from one to seven years, the results were found to be unpredictable or poor in the patients with inflammatory arthritis or hemophilia, while a stable, painless elbow with a functional range of motion was achieved in four of the five patients with post-traumatic lesions.