The application of a haemorrhage assessment tool in evaluating control of bleeding in a pilot trauma haemorrhage trial.

OBJECTIVES: To determine whether it was feasible to use a haemorrhage assessment tool (HAT) within a trauma trial and whether the data obtained could differentiate patients who had achieved haemostasis. BACKGROUND: Major haemorrhage is one of the leading causes of death worldwide, affecting 40% of trauma patients. Clinical trials evaluating haemostatic interventions often use transfusion outcomes as a primary endpoint. Transfusion is highly dependent on local practice, limiting its reliability as a robust, transferable endpoint. METHODS: A five-point HAT questionnaire was applied to participants enrolled into the EFIT-1 trial. This RCT evaluated the feasibility of administering a 6 g fibrinogen concentrate to patients with severe trauma haemorrhage. RESULTS: Of participants, 98% completed a HAT; 75% participants had 'achieved haemostasis' at the time of tool completion, as determined by clinical acumen alone. HAT scores were able to differentiate which participants required transfusion after 3 h. Of participants, 56% were transfused red blood cells when they scored 0-2, compared to 17% with HAT scores between 3 and 5. CONCLUSION: This study has confirmed the feasibility of using a HAT during the emergency care of patients suffering trauma haemorrhage, and future studies should be conducted to determine its value as an endpoint in haemostasis studies.

A randomised controlled trial of the use of aciclovir and/or prednisolone for the early treatment of Bell's palsy: the BELLS study.

OBJECTIVE: To determine whether oral prednisolone or aciclovir, used separately or in combination, early in the course of Bell's palsy, improves the chances of recovery at 3 and 9 months. DESIGN: A 2 x 2 factorial randomised double-blind trial. Patients were randomly assigned to treatment by an automated telephone service using a permuted block randomisation technique with block sizes of four or eight, and no stratification. SETTING: Mainland Scotland, with referrals mainly from general practice to 17 hospital trial sites. PARTICIPANTS: Adults (aged 16 years or older) with unilateral facial nerve weakness of no identifiable cause presenting to primary care, the emergency department or NHS24 within 72 hours of symptom onset. INTERVENTIONS: Patients were randomised to receive active preparations or placebo for 10 days: (1) prednisolone (50 mg per day, 2 x 25-mg capsules) and aciclovir (2000 mg per day, 5 x 400-mg capsules); (2) prednisolone and placebo (lactose, indistinguishable); (3) aciclovir and placebo; and (4) placebo and placebo. OUTCOME MEASURES: The primary outcome was recovery of facial function assessed by the House-Brackmann scale. Secondary outcomes included health status, pain, self-perceived appearance and cost-effectiveness. RESULTS: Final outcomes were available for 496 patients, balanced for gender; mean age 44 years; initial facial paralysis moderate to severe. One half of patients initiated treatment within 24 hours of onset of symptoms, one-third within 24-48 hours and the remainder within 48-72 hours. Of the completed patients, 357 had recovered by 3 months and 80 at 9 months, leaving 59 with a residual deficit. There were significant differences in complete recovery at 3 months between the prednisolone comparison groups (83.0% for prednisolone, 63.6% for no prednisolone, a difference of + 19.4%; 95% confidence interval (CI): + 11.7% to + 27.1%, p < 0.001). The number needed to treat (NNT) in order to achieve one additional complete recovery was 6 (95% CI: 4 to 9). There was no significant difference between the aciclovir comparison groups (71.2% for aciclovir and 75.7% for no aciclovir). Nine-month assessments of patients recovered were 94.4% for prednisolone compared with 81.6% for no prednisolone, a difference of + 12.8% (95% CI: + 7.2% to + 18.4%, p < 0.001); the NNT was 8 (95% CI: 6 to 14). Proportions recovered at 9 months were 85.4% for aciclovir and 90.8% for no aciclovir, a difference of -5.3%. There was no significant prednisolone-aciclovir interaction at 3 months or at 9 months. Outcome differences by individual treatment (the four-arm model) showed significant differences. At 3 months the recovery rate was 86.3% in the prednisolone treatment group, 79.7% in the aciclovir-prednisolone group, 64.7% in the placebo group and 62.5% in the aciclovir group. At 9 months the recovery rates were respectively 96.1%, 92.7%, 85.3% and 78.1%. The increase in recovery rate conferred by the addition of prednisolone (both for prednisolone over placebo and for aciclovir-prednisolone over aciclovir) is highly statistically significant (p < 0.001). There were no significant differences in secondary measures apart from Health Utilities Index Mark 3 (HUI3) at 9 months in those treated with prednisolone. CONCLUSIONS: This study provided robust evidence to support the early use of oral prednisolone in Bell's palsy as an effective treatment which may be considered cost-effective. Treatment with aciclovir, either alone or with steroids, had no effect on outcome.

Drumming up dollars for stem cell research.

With stringent U.S. federal restrictions on funding for human embryonic stem cell research still in place, states grapple with the issue of whether to fund such research themselves.

Epidemiology, clinical characteristics, and management of adults referred to a teaching hospital first seizure clinic.

BACKGROUND: There are scarce data describing the epidemiology, clinical characteristics, and management of adults who suffer a suspected first seizure. AIM: To describe the epidemiology, clinical characteristics, and management of adults with a suspected first seizure who are referred to a teaching hospital first seizure clinic over a one year period. DESIGN: Prospective descriptive study. METHODS: Data were collected on consecutive adults referred to the Royal Infirmary of Edinburgh between 4 February 2003 and 10 February 2004. RESULTS: 232 patients were referred to the first seizure clinic. Median age was 32 years; 53% of patients were male. Lower socioeconomic groups were more likely to present with a suspected first seizure. Nineteen per cent of patients were admitted to hospital after their suspected seizure episode. Appropriate driving advice was reported in 64% of cases. Seventy two per cent of patients were offered a first seizure clinic appointment within six weeks of referral. Nine per cent of patients had a subsequent seizure while awaiting review. Fifty two per cent of patients were confirmed as having a first seizure at the clinic, of which 56% were provoked by alcohol, recreational drugs, or sleep deprivation. Electroencephalography and computed tomography of the brain were the most common investigations ordered at the first seizure clinic (22% and 22% of patients respectively). CONCLUSION: Adults who suffer a suspected first seizure, and who make a full neurological recovery, can be safely managed as an outpatient. Around half of these patients will have a specialist diagnosis of first seizure and alcohol will be a common precipitating factor.

Oral health status of second grade school children in upstate New York.

This report summarizes the results of a survey of second grade children conducted in upstate New York. The survey was designed to monitor progress toward achieving Healthy People 2000 objectives and Maternal and Child Health Services Block Grant performance measures. Data on oral health status, use of preventive measures and insurance coverage were collected on 2,474 children from 76 schools. In addition to obtaining population estimates, disparities in oral health between poor and nonpoor children were assessed. The results showed that approximately 52% of second grade children had dental caries, and 35% had untreated disease. Approximately 43% received fluoridated water, and 44% of children living in non-fluoridated areas used fluoride supplements on a regular basis. Only 25% of the children had dental sealants. The percentage of children covered by comprehensive and basic insurance plans was approximately 19% and 41%, respectively. Many of the national oral health objectives were not met primarily because of the higher rate of disease among the poor and their lower use of preventive services. These findings regarding oral health status and use of preventive services are similar to the national data.

Revisiting the issue: can the reading for serologic reactivity following 37 degrees C incubation be omitted?

BACKGROUND: Omitting the 37 degrees C reading from screening tests for unexpected antibodies results in failure to detect some Rh, K, and Jk agglutinins of potential significance (wanted positives). However, this measure avoids unwanted positive tests due to cold agglutinins. STUDY DESIGN AND METHODS: Using data from prior publications, actual risk calculations (ARCs) were made to predict the risk of eliminating the 37 degrees C reading, pretransfusion direct antiglobulin test (DAT), and routine indirect antiglobulin crossmatch (IAT-XM). ARCs used the equation: wanted positives missed x 0.34 (or 0.80) x 5 x percent antigen-positive, where 0.34 = percent of patients transfused (ARCs for 37 degrees C reading and DAT); 0.80 = percent of crossmatched patients transfused (ARCs for IAT-XM); 5 = average number of units transfused. Following elimination of the 37 degrees C reading, the impact of this change on patient care was monitored. Antibody detection and identification data and transfusion reaction reports for 6 months after the change were reviewed. Recently transfused patients with new antibodies were evaluated for immune hemolysis by review of clinical and laboratory data. The findings were compared with those from the same dates of the preceding year. RESULTS: The risk of transfusing incompatible blood by eliminating the DAT, IAT-XM, and 37 degrees C reading is approximately 1:13,000, 1:2,000, and 1:2,400 units transfused, respectively. The cumulative risk from eliminating all three tests is approximately. 1 :1,000 units. With respect to the 37 degrees C reading, there were no differences between the pre-change and post-change study periods in the incidence of reported transfusion reactions or cases of immune hemolysis associated with newly formed antibodies. However, unwanted positive tests decreased from 162 to 61 following elimination of the 37 degrees C reading. This represents a decrease of 20 percent in the number of samples requiring antibody identification annually. CONCLUSIONS: Eliminating the 37 degrees C reading from pretransfusion antibody screening tests imposes less risk than omitting the routine IAT-XM, and it avoids the time and costs of evaluating unwanted positive tests, thus reducing expenditures and delays in patient care.

Assessing the economic value of antihypertensive medications.

OBJECTIVE: To assess the economic value of antihypertensive medications by comparing the likelihood of coronary heart disease and stroke events and subsequent event treatment costs. STUDY DESIGN: Duration of blood pressure reduction was used to profile event risk reduction of three antihypertensive medications. METHODS: We used clinical data to determine the duration of blood pressure reduction achieved with use of two angiotensin converting enzyme inhibitors and one angiotensin II receptor antagonist. We then used trough-to-peak ratios to calculate the reduction in risk of coronary heart disease and stroke events associated with each medication. RESULTS: Across a number of different event treatment cost and population size estimates, the economic value of different medications can be assessed. CONCLUSION: Our method for assessing the economic value of antihypertensive medications can be applied to other drug classes and can be further refined by integrating patient population and other risk-related data.

Effect of correcting outcome data for case mix: an example from stroke medicine.

OBJECTIVE: To show the influence of variations in case mix on clinical outcome indicators for patients admitted to hospital with acute stroke. DESIGN: "Before and after" cohort study, with prospective, consecutive identification of patients and prospective follow up; multiple logistic regression analyses to correct for case mix variations. SETTING: University teaching hospital. SUBJECTS: 216 patients with stroke identified before the introduction of an organised stroke service, and 252 patients with stroke identified after its introduction. MAIN OUTCOME MEASURES: Case fatality at 30 days and 12 months; for survivors at 12 months, proportions of patients who were independent (according to the Oxford handicap scale) and of those living at home. RESULTS: Crude outcome data suggested that patients in the cohort identified after the introduction of the stroke service were significantly more likely to be alive, independent, and living at home than patients managed before the stroke service. After adjustment for age and sex these "improvements" were less impressive but still significant. After adjustment for many other possible prognostic indicators, however, the differences between the two groups for all four outcomes were non-significant, suggesting that the "improvements" may have been entirely due to differences in case mix between the two cohorts, rather than the new stroke service. CONCLUSIONS: Variations in case mix have a crucial influence on the interpretation of outcome data, and this is particularly important in non-randomised comparative studies. Such studies, comparing performance within and between different provider units, are likely to become increasingly common in the new reformed NHS. To allow meaningful interpretation, these studies must try to correct for case mix.

Run training vs cross training: influence of increased training on running economy, foot impact shock and run performance.

The purpose of the study was to compare changes in running economy, foot impact shock, run performance, and resting heart rate and blood pressure elicited by increases in training volume via run training (RT) and cross training (CT). After 30 d of normal training (NT), male runners (N = 11) completed two 10 d periods of increased training each preceded by 14 d of reduced training (80% NT). Subjects ran 10 consecutive days in the afternoon (100% of NT) and performed 8 additional workouts in the morning (100% of NT). The morning sessions were performed on a cycle ergometer (CT) or a treadmill (RT). Running economy, foot impact shock and lactate were assessed during submaximal running (3.9 +/- 0.06 m.sec-1) at D0 and D11. Following the submaximal run, subjects completed a simulated 5 km race on a treadmill. VO2 during the running economy test was significantly higher at D11 of CT (52.5 +/- 1.5) compared to RT (51.1 +/- 1.4 ml.kg-1.min-1). RER, carbohydrate oxidation, and lactate were significantly lower; whereas, foot impact shock was significantly higher following both training modes. No significant changes in run performance, resting heart rate and blood pressure occurred during the study. In summary, 10 d of increased training resulted in a reduced running economy for CT, and a lower carbohydrate oxidation and an increase in foot impact shock for both training modes.

Improving the recording of the clinical assessment of stroke patients using a clerking pro forma.

In this study we examine whether the introduction of a clerking pro forma improves the completeness of the recording of the management of stroke patients and we review methodological issues important in this type of audit. We prospectively identified 244 consecutive stroke patients before and after the introduction of the pro forma. Patient case notes were traced and audited using a specifically designed form. Following the introduction of the pro forma, there was a significant improvement in the completeness of the recording of patient management; no change was observed for those items not included in the pro forma, suggesting a causal effect. We conclude that a stroke clerking pro forma improves the completeness of the recording of the assessment of hospitalized stroke patients; this has implications for clinical practice and future audit and may be applicable to other common conditions. We emphasize that methodological problems associated with a case note audit must be addressed if it is to produce useful, comparative data.

Immunohistochemical assessment of proliferative activity in adrenocortical neoplasms.

Although many histologic criteria have been utilized to help distinguish benign from malignant adrenocortical tumors, it still may be difficult to assess the biologic potential of a given tumor. We evaluated 19 adenomas and 15 primary carcinomas with the avidin-biotin complex peroxidase method utilizing formalin-fixed, paraffin-embedded tissues with monoclonal antibodies for proliferating cell nuclear antigen (PC10) and Ki-67 (MIB 1) to determine if staining for these antigens could be used to help differentiate benign from malignant adrenocortical neoplasms. We also evaluated whether these markers could be used as prognostic indicators. Labeling indices for both PCNA and Ki-67 were determined by enumerating 1000 tumor cells, and expressed as a percentage of cells with nuclear staining. A PCNA and a Ki-67 score was obtained by the product of the staining intensity (0-3+) and the extent of nuclear staining, expressed as an estimate of the percentage of cells staining. Both PCNA and Ki-67 score and labeling index were correlated with mitotic counts, histologic diagnosis, and clinical outcome. Follow-up period for patients ranged from 4 months to 12 years with a mean of 25 months. Mitotic counts correlated with histologic diagnosis and clinical outcome. Both Ki-67 score and labeling index were significantly higher in malignant than in benign tumors, and correlated with mitotic counts and clinical outcome. There was a strong correlation between Ki-67 score and labeling index, indicating that Ki-67 score may be a more rapid and equally accurate method of estimating proliferative index of a tumor. PCNA score and labeling index did not correlate with histologic diagnosis or clinical outcome.(ABSTRACT TRUNCATED AT 250 WORDS)