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G R Cutter

Publications and source records attributed to G R Cutter.

At least 37 records · Page 2Linked to original sources
PubMed1999

Development of a multiple sclerosis functional composite as a clinical trial outcome measure.

The primary clinical outcome measure for evaluating multiple sclerosis in clinical trials has been Kurtzke's expanded disability status scale (EDSS). New therapies appear to favourably impact the course of multiple sclerosis and render continued use of placebo control groups more difficult. Consequently, future trials are likely to compare active treatment groups which will most probably require increased sample sizes in order to detect therapeutic efficacy. Because more responsive outcome measures will be needed for active arm comparison studies, the National Multiple Sclerosis Society's Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis appointed a Task Force that was charged with developing improved clinical outcome measures. This Task Force acquired contemporary clinical trial and historical multiple sclerosis data for meta-analyses of primary and secondary outcome assessments to provide a basis for recommending a new outcome measure. A composite measure encompassing the major clinical dimensions of arm, leg and cognitive function was identified and termed the multiple sclerosis functional composite (MSFC). The MSFC consists of three objective quantitative tests of neurological function which are easy to administer. Change in this MSFC over the first year of observation predicted subsequent change in the EDSS, suggesting that the MSFC is more sensitive to change than the EDSS. This paper provides details concerning the development and testing of the MSFC.

Clinical Trials as Topic↗
PubMed1999

The Multiple Sclerosis Functional Composite Measure (MSFC): an integrated approach to MS clinical outcome assessment. National MS Society Clinical Outcomes Assessment Task Force.

Clinical outcome assessment in Multiple Sclerosis (MS) is challenging due to the diversity and fluctuating nature of MS symptoms. Traditional clinical scales such as the EDSS are inadequate in their assessment of key clinical dimensions of MS (e.g. , cognitive function), and they have psychometric limitations as well. Based on analyses of pooled data from natural history studies and from placebo groups in clinical trials, the National MS Society's Clinical Outcomes Assessment Task Force recently proposed a new multidimensional clinical outcome measure, the MS Functional Composite (MSFC). The MSFC comprises quantitative functional measures of three key clinical dimensions of MS: leg function/ambulation, arm/hand function, and cognitive function. Scores on component measures are converted to standard scores (z-scores), which are averaged to form a single MSFC score. Preliminary analyses confirm that: (1) the three clinical dimensions of the MSFC are relatively independent; (2) the MSFC is sensitive to clinical changes over 1- and 2-year intervals; and (3) the MSFC has acceptable criterion validity (i.e., predicts both concurrent and subsequent EDSS change). The advantages and potential limitations of incorporating quantitative functional outcome measures such as the MSFC into collaborative databases are discussed.

Clinical Trials as Topic↗
PubMed1998

Improvement in mammography quality control: 1987-1995.

PURPOSE: To assess possible changes in quality control (QC) practices at mammography sites in the United States. MATERIALS AND METHODS: Mammography site surveys were conducted in 1990, 1992, and 1995 through the Colorado Mammography Advocacy Project (CMAP). Data from mammography sites applying for American College of Radiology (ACR) accreditation were collected between August 1987 and August 1993 through the ACR Mammography Accreditation Program. Data from both of these surveys were analyzed to assess temporal changes in mammography QC practices in the United States between 1987 and 1995. RESULTS: CMAP results indicated statistically significant improvement in medical physicist QC practices between 1990 and 1992 and in technologist QC practices between 1990 and 1995. Improvements in radiologic technologist QC practices coincided with increases in radiologic technologist continuing education in mammography. ACR results indicated statistically significant improvement in technologist QC practices between 1988 and 1992. CONCLUSION: There have been substantial improvements in QC practices at mammography sites in the United States during the past decade.

Chi-Square Distribution↗
PubMed1997

A classification system to evaluate weight maintainers, gainers, and losers.

OBJECTIVES: To study natural weight changes and to develop a weight classification system that can identify weight maintainers, gainers, and losers. DESIGN/OUTCOME: A prospective, observational study in which weight changes over five annual measurements were evaluated. In the weight classification system used, changes greater than 5 lb defined weight maintenance, gain, or loss. SUBJECTS/SETTINGS: Subjects were healthy, normal-weight and over weight, men and women (mean age = 44.1 +/- 14.1 years) in the Relationships of Energy, Nutrition, and Obesity to Cardiovascular Disease Risk Study. Prospective data for 385 of the original 508 subjects for whom actual weights were available for each of the 5 years (1985 to 1990) were used to classify and characterize subjects by weight-change categories. STATISTICAL ANALYSES: Cross-tabulations (with chi 2 tests) and hterarchical log-linear analyses (with partial chi 2 tests) to examine the relationships of categorical variables; analyses of variance (with F tests) for continuous measures. RESULTS: Over the 4-year interval, 46% of subjects were classified as maintainers, 34% as gainers, and 20% as losers. Over shorter 1-year epochs, more subjects were maintainers (62%) and fewer subjects were gainers (22%) or losers (16%). Maintainers had fewer and smaller magnitudes of weight fluctuations and showed fewer deleterious changes in health risk factors than gainers. APPLICATIONS: Weight changes of greater than +/-5 lb can classify a person as a weight maintainer, or loser. Although annual weight changes were used in this study, a weight change of more than 5 lb between any two points in time may suggest nonmaintenance of weight or weight instability that needs further evaluation.

Adult↗
PubMed1997

Randomized, multicenter trial of inhaled nitric oxide and high-frequency oscillatory ventilation in severe, persistent pulmonary hypertension of the newborn.

BACKGROUND: Although inhaled nitric oxide (iNO) causes selective pulmonary vasodilation and improves oxygenation in newborn infants with persistent pulmonary hypertension, its effects are variable. We hypothesized (1) that the response to iNO therapy is dependent on the primary disease associated with persistent pulmonary hypertension of the newborn (PPHN) and (2) that the combination of high-frequency oscillatory ventilation (HFOV) with iNO would be efficacious in patients for whom either therapy alone had failed. METHODS: To determine the relative roles of iNO and HFOV in the treatment of severe PPHN, we enrolled 205 neonates in a randomized, multicenter clinical trial. Patients were stratified by predominant disease category: respiratory distress syndrome (n = 70), meconium aspiration syndrome (n = 58), idiopathic PPHN or pulmonary hypoplasia (excluding congenital diaphragmatic hernia) ("other": n = 43), and congenital diaphragmatic hernia (n = 34); they were then randomly assigned to treatment with iNO and conventional ventilation or to HFOV without iNO. Treatment failure (partial pressure of arterial oxygen [PaO2] < 60 mm Hg) resulted in crossover to the alternative treatment; treatment failure after crossover led to combination treatment with HFOV plus iNO. Treatment response with the assigned therapy was defined as sustained PaO2 of 60 mm Hg or greater. RESULTS: Baseline oxygenation index and PaO2 were 48 +/- 2 and 41 +/- 1 mm Hg, respectively, during treatment with conventional ventilation. Ninety-eight patients were randomly assigned to initial treatment with HFOV, and 107 patients to iNO. Fifty-three patients (26%) recovered with the initially assigned therapy without crossover (30 with iNO [28%] and 23 with HFOV [23%]; p = 0.33). Within this group, survival was 100% and there were no differences in days of mechanical ventilation, air leak, or supplemental oxygen requirement at 28 days. Of patients whose initial treatment failed, crossover treatment with the alternate therapy was successful in 21% and 14% for iNO and HFOV, respectively (p = not significant). Of 125 patients in whom both treatment strategies failed, 32% responded to combination treatment with HFOV plus iNO. Overall, 123 patients (60%) responded to either treatment alone or combination therapy. By disease category, response rates for HFOV plus iNO in the group with respiratory syndrome and the group with meconium aspiration syndrome were better than for HFOV alone or iNO with conventional ventilation (p < 0.05). Marked differences in outcomes were noted among centers (percent death or treatment with extracorporeal membrane oxygenation = 29% to 75%). CONCLUSIONS: We conclude that treatment with HFOV plus iNO is often more successful than treatment with HFOV or iNO alone in severe PPHN. Differences in responses are partly related to the specific disease associated with PPHN.

Administration, Inhalation↗
PubMed1997

The pediatric costs of strategies for minimizing the risk of early-onset group B streptococcal disease.

OBJECTIVE: To estimate the pediatric costs associated with the Centers for Disease Control and Prevention (CDC) guidelines for the management of infants born to mothers receiving intrapartum antimicrobial prophylaxis for prevention of early-onset group B streptococcal disease. METHODS: For an annual United States birth cohort of 3.95 million infants, we estimated the cost of pediatric care provided to full-term asymptomatic infants when pediatricians followed the CDC algorithm for the management of infants exposed to intrapartum antimicrobial prophylaxis under culture-based and risk factor-based maternal care approaches. We calculated the relative contribution of pediatric costs to the total costs of preventing a case of early-onset group B streptococcal sepsis. RESULTS: Total pediatric costs were $41 million for a culture-based approach and $33 million for a risk factor-based approach. Hospital and physician costs accounted for more than 78% of this total. The majority (over 95%) of the pediatric costs were associated with vaginal deliveries. Incorporating pediatric costs into previous cost-effectiveness analyses increased the cost per sepsis case averted by as much as 51% for culture-based strategies and by as much as 112% for risk factor-based strategies. Pediatric costs varied with the average length of stay for full-term infants and with the average cost of a hospital day. CONCLUSION: Substantial pediatric costs are associated with the implementation of an obstetric strategy for minimizing the risk of early-onset group B streptococcal disease. Such costs should be included in future cost-effectiveness analyses of different strategies for minimizing the risk of group B streptococcal disease in newborns.

Algorithms↗
PubMed1997

Long-term survival of African Americans in the Coronary Artery Surgery Study (CASS).

OBJECTIVES: This study sought to determine the long-term (> 15 years) outcome of a clinically well characterized cohort of African Americans with known or suspected coronary artery disease (CAD). BACKGROUND: The mortality rate from CAD is higher in African Americans than in whites. An earlier analysis of data from the Coronary Artery Surgery Study (CASS) registry suggested that African American and white patients treated surgically had equal 5-year survival rates. METHODS: Survival data from the CASS registry were analyzed to determine whether 1) African American race is an independent predictor of mortality; and 2) initial therapy is predictive of mortality among African American patients. RESULTS: Overall, 60% of white and 52% of African American patients survived 16 years (p < 0.00001). Multivariate Cox models confirmed that African American race was independently associated with higher mortality in both the medical group (hazard ratio [HR] 1.34, 95% confidence interval [CI] 1.11 to 1.63) and the surgical group (HR 1.63, 95% CI 1.19 to 2.23). Initial therapy was not predictive of survival among African American patients (p = 0.81). However, smoking status significantly influenced survival: African Americans who did not smoke experienced significantly improved survival (60% vs. 48% for smokers), which equaled survival for white nonsmokers (61%, p = NS). CONCLUSIONS: In contrast to results from shorter term studies, African Americans experienced higher overall mortality rates than whites over the long term, regardless of the type of initial treatment. Survival among nonsmoking African Americans at 16 years equaled survival among nonsmoking whites.

Adult↗
PubMed1997

Evaluating the value of low-vision services.

BACKGROUND: Low-vision care is a widely accepted and valued service provided by many optometrists. As in other areas of health care, evaluation of the outcome of low-vision care is increasingly necessary so it can be properly positioned in the health care delivery system. METHODS: This article reviews the literature relating to the prevalence of low vision, its impact on affected individuals, and how low-vision intervention affects those with visual impairments. This review considers the ways in which the impact of low-vision care has been evaluated. RESULTS: The existing literature demonstrates that low-vision intervention can be highly valued by low-vision patients and can have a significant impact on an individual's daily life and activities. Evaluating this impact is a significant challenge-particularly if the goal is to gauge the outcome of low vision care as broadly as possible. CONCLUSIONS: Evaluation of health-related quality of life is a desirable option for evaluation of outcomes, and the application of quality of life instruments to the visually impaired population is necessary. There remain unresolved issues of optometric research that need to be addressed.

Delivery of Health Care↗
PubMed1996

Impact of maternal group B streptococcal screening on pediatric management in full-term newborns.

BACKGROUND: The American Academy of Pediatrics strategy to prevent early-onset neonatal sepsis with group B streptococcus (GBS) relies on maternal antepartum GBS cultures, while the American College of Obstetrics and Gynecology strategy does not. OBJECTIVE: To evaluate the impact of the 2 strategies on the care of asymptomatic full-term newborns. DESIGN/SETTING: Self-administered survey mailed to a national random sample of US pediatricians who were members of the American Academy of Pediatrics. PARTICIPANTS: A total of 461 members of the American Academy of Pediatrics who routinely care for newborns. MAIN OUTCOME MEASURE: Self-report of diagnostic and treatment strategies for asymptomatic full-term newborns who were born under different clinical scenarios. Maternal risk factors, antepartum maternal GBS screening status, and maternal treatment with intrapartum antibiotics were varied across the scenarios. RESULTS: Pediatricians treating asymptomatic full-term newborns born to risk factor-negative mothers reported ordering tests (63.3% in GBS-positive cases vs 6.7% with GBS unknown; P = .001) and antibiotics (21.5% in GBS-positive cases vs 0.9% with GBS unknown; P = .001) more frequently when presented with a positive maternal GBS screening result. Maternal intrapartum treatment had little impact on pediatric practice when risk factors were absent. In risk factor-positive mothers, pediatricians reported an increase in their antibiotic usage in response to a positive maternal GBS screen (61.8% in GBS-positive cases vs 36.9% with GBS unknown; P = .001). In risk factor-positive mothers with unknown results of GBS screening, use of intrapartum antibiotics increased the number of pediatricians who reported that they would prescribe antibiotic therapy. CONCLUSIONS: Obstetrical strategies to decrease the risk of neonatal GBS sepsis increase pediatric services provided to full-term healthy newborns. This increase in services by pediatric practices is likely to be greater with the screening-based strategy recommended by the American Academy of Pediatrics.

Adult↗
PubMed1996

The clinical presentation, prevalence, and risk factors of focal corneal infiltrates in soft contact lens wearers.

PURPOSE: We evaluated the clinical presentation, prevalence, and associated risk factors for focal corneal infiltrates with overlying fluorescein staining in a population of soft contact lens wearers. METHODS: We measured the prevalence of focal stromal infiltrates with overlying fluorescein staining among contact lens wearers in a large cross-sectional, masked, multicenter study. RESULTS: The practice-based occurrence of infiltrates with overlying staining was 1.6%, or 38 of 2,324 patients examined. The events were milder than those reported in studies conducted in specialty eye care centers; were usually noted during unscheduled office visits; and were accompanied by symptoms of redness, photophobia, pain, and foreign body sensation. The infiltrates were located in all corneal zones, with 44.7% of the infiltrates involving the central zone, none of which caused significant loss of acuity at follow-up. The risk factors of overnight wear, lens modality (e.g., conventional, disposable), and smoking have been confirmed. Overnight wear showed a prevalence ratio of 1.88 compared with daily wear (P < 0.055, chi-square); lens modality showed an increased risk for disposables compared with conventional lenses of 2.1 (P = 0.036, chi-square). Smoking was associated with an increased prevalence of events; 1.2% of "never" and 2.2% and 2.4% of "former" and "current" smokers, respectively, experienced an infiltrate, for a prevalence ratio of 2.0 (P < 0.04). Smoking and lens modality also interacted positively with extended wear, amplifying the risk associated with those factors. CONCLUSIONS: We found a 1.6% practice-based prevalence and a wide range of clinical presentation of focal infiltrates in soft contact lens wearers, and we measured the relative risks of extended wear, lens modality, and smoking in a general practice population. In these cases, there was no distinct pattern in location or severity of corneal infiltrates, and visual acuity following the events was not compromised.

Adult↗
PubMed1995

Who are the weight maintainers?

To characterize people who maintain weight over long periods of time, normal weight and obese adults (n = 385) were studied over five annual visits. Subjects were classified using a +/- 5 lb change between the first and the fifth year visits to determine overall maintenance (M), with gain (G) or loss (L) being any change outside this range. This MGL status was cross-tabulated with a Fluctuation Index which counted the number of successive year-to-year weight changes of more than +/- 5 lbs (F0 through F4). True maintainers were defined as those having all weight changes within +/- 5 lbs during the 5-year period (M and F0). Nineteen percent (n = 73) of the subjects were classified as True Maintainers and included three times as many normal weight as obese subjects. Obese subjects comprised only 25% of the True Maintainer group but 60% of the Non-Maintainer group. Age had no association with Maintainer status. Standard measures of weight variability were lowest among True Maintainers and highest in Non-Maintainers. In addition, True Maintainers had lower BMI, Percent Body Fat, and Waist-Hip Ratios than Non-Maintainers. Subjects classified as Non-Maintainers were more likely to engage in dieting, by a variety of measures, than True Maintainers--this was particularly true among obese subjects. Finally, changes in total cholesterol, LDL and HDL cholesterol, and systolic and diastolic blood pressure were not reliably associated with Maintainer status, although the ordering of the group means suggested that True Maintainers had slightly healthier levels of "risk" variables. Overall, the results suggest that True Maintainers comprise a potentially important and interesting group of individuals who need further study.

Adult↗
PubMed1995

Maternal serum thromboxane B2 reduction versus pregnancy outcome in a low-dose aspirin trial.

OBJECTIVE: Our purpose was to determine whether in a low-dose aspirin trial a longitudinal decrease in maternal serum thromboxane B2 is associated with improvement in pregnancy outcomes. STUDY DESIGN: A total of 606 healthy nulliparous women with singleton gestations were randomized at 24 weeks to either 60 mg of aspirin or a placebo. Maternal serum thromboxane B2 was measured at randomization, at 29 to 31 weeks, at 34 to 36 weeks, and at delivery. After delivery, and without knowledge of patient outcome or group assignment, patients were categorized as having had either a longitudinal twofold or greater (> or = 50%) or less than twofold reduction (< 50%) in thromboxane B2 from baseline levels at randomization. RESULTS: Of 606 entrants, 92% had sufficient thromboxane B2 determinations to allow categorization. Whether patients were assigned to aspirin or placebo, birth weight was significantly greater in women who had a twofold or greater reduction in maternal serum thromboxane B2 levels. When the aspirin and placebo groups were combined, women with a twofold or greater reduction in thromboxane B2 levels had less preeclampsia, 1.9% (6/314) versus 5.7% (14/244) (p = 0.016), less preterm delivery (5.7% vs 10.7%, p = 0.032), fewer small-for-gestational-age newborns, 9 of 314 (2.95) versus 17 of 244 (7%) (p = 0.023), and a higher mean birth weight, 3314 gm versus 3121 gm (p = 0.0001). CONCLUSION: Women with a twofold or greater longitudinal reduction in maternal serum thromboxane B2 had less preeclampsia and prematurity, fewer small-for-gestational-age newborns, and higher birth weights than women with less than a twofold reduction.

Aspirin↗
PubMed1995

Cervical examination and tocodynamometry at 28 weeks' gestation: prediction of spontaneous preterm birth.

OBJECTIVE: We determined the value of cervical examination and tocodynamometry in identifying nulliparous women at risk for spontaneous preterm delivery. STUDY DESIGN: At 27.5 +/- 0.8 weeks' gestation 589 women underwent 30 minutes of tocodynamometry, and 570 of these had a cervical examination. Positive findings on these examinations were compared to the rate of spontaneous preterm delivery, defined as those deliveries following the onset of spontaneous labor or premature rupture of membranes. RESULTS: The two best predictors of spontaneous preterm birth were two or more contractions in 30 minutes and the presence of a soft or medium consistency on cervical examination. As the contractions increased from zero to four or more, the rate of spontaneous preterm delivery rose from 4.2% to 18.2%. CONCLUSION: In nulliparous women at 28 weeks' gestation, uterine contractions and several components of the cervical examination predicted spontaneous preterm birth.

Adolescent↗
PubMed1995

Differences in the detection and enumeration of mutans streptococci due to differences in methods.

Different methods reported for assessing mutans streptococci (MS) make the direct comparisons of results across studies difficult. To quantitate the variations of MS estimates attributable to differences in method, stimulated and unstimulated saliva samples and oral swab samples were compared with pooled dental-plaque samples. Detection of MS in stimulated saliva samples was in excellent agreement with the presence of MS in pooled plaque samples. MS detection in unstimulated saliva samples, however, was significantly discordant with that in either pooled plaque or oral swab samples. When caries status was used as the criterion of validity of MS estimates, stimulated saliva samples demonstrated a sensitivity (94%) similar to that of pooled plaque samples, but exhibited a lower specificity (11%) than that of pooled plaque samples (17%). As a result, the measure of association between MS and caries was biased (towards null) when MS status was based on stimulated saliva samples. Interestingly though, in enumerating MS, stimulated saliva samples yielded significantly higher levels of MS (about 1.5 log10 increase) with a lower variability compared to unstimulated saliva samples. The use of different culture media for detection of MS gave different results as well. MS detection was poor (kappa = 0.31) and MS levels were lower (p = 0.0001) when samples were grown on glucose-sucrose-potassium tellurite-bacitracin agar compared to mitis-salivarius-bacitracin agar. Together with the relative ease of sampling and processing, these findings collectively justify the use of plaque samples for the qualitative assessment of MS and stimulated saliva samples for the quantitative assessment of MS, while providing a basis for adjustment of estimates when comparing results across studies.

Analysis of Variance↗
PubMed1995

The relationship between maternal and neonatal anthropometric measurements in term newborns.

OBJECTIVE: To determine whether measures of maternal lean mass, fat reserves, or a combination of both best predict the various measures of newborn size at birth. METHODS: The population consisted of 1205 multiparous, predominantly black women at high risk for fetal growth retardation, who delivered at term at the University of Alabama at Birmingham. Maternal body mass index (BMI) was calculated using the reported pre-pregnancy weight. Maternal anthropometric measurements taken at mid-pregnancy included skinfold thicknesses, lean body mass, and mid-arm, calf, and wrist circumferences. Weight and 11 other neonatal measurements were made within 24 hours of birth and related to various maternal anthropometric measurements. RESULTS: Reported maternal pre-pregnancy weight was the best predictor of all neonatal size measures except for the neonatal skinfold thicknesses, which were better predicted by the pre-pregnancy BMI. For example, the range between the tenth and 90th percentiles of maternal pre-pregnancy weight (46.3-86.4 kg) was associated with 295 g birth weight compared to only 188 g birth weight for a measure of lean body mass. CONCLUSION: Most maternal anthropometric measurements were significantly associated with most neonatal measurements. However, for nearly every neonatal measurement considered, the maternal pre-pregnancy weight was the best predictor.

Adult↗