The growth and development of a research study: why stroke survivors wait so long.

The recent focus on stroke treatment has revealed that stroke survivors are not reaching emergency care early enough to benefit from available treatment modalities. As a result, the authors designed a study to determine the factors that influence the timing of seeking health care for stroke symptoms. Encouraged and supported by peers across the country, it became a collaborative national multicenter research study. This article describes the process used to develop the research study, as well as the challenges encountered along the way.

The absorption and effect of dietary supplementation with omega-3 fatty acids on serum leukotriene B4 in patients with cystic fibrosis.

The substitution of omega-3 (n-3) fatty acids for omega-6 (n-6) fatty acids generates eicosanoids with diminished inflammatory effects. As the lungs of patients with cystic fibrosis (CF) are in a state of chronic inflammation in which increased amounts of eicosanoids are found, n-3 supplementation may reduce this level of inflammation and result in clinical improvement. The absorption and clinical effects of n-3 vs. n-6 fatty acids in CF were measured in a prospective, randomized, double-blind, crossover study in which 14 patients with CF (age: 6-16 years, mean 10.5 years; baseline Shwachman-Brasfield scores: 41-88, mean 76.7) received 6 weeks of n-3 ethyl ester concentrate from menhaden oil (100-131 mg/kg/day, mean 112.8) or n-6 fatty acids from safflower oil (102-132 mg/kg/day, mean 113.3), followed by a washout period of 6 weeks, and then 6 weeks of the other supplement. Analysis by gas chromatography showed that n-3 supplementation resulted in increased eicosapentaenoic acid (20:5n-3) in platelet phospholipids, from 0.14 to 2.16%, P < 0.05 and in increased docosahexaenoic acid (22:6n-3), from 1.33 to 3.72%, P < 0.05. Clinical effects were evaluated at weeks 0, 6, 12, and 18, and analyzed for differences among the n-3, n-6, and washout periods. No adverse effects were reported or observed. No statistically significant differences were found (ANOVA, P > 0.05) in Shwachman-Brasfield scores, sweat test, weight change, or forced expiratory volume and flow (FEV1, FEF25-75%, and FVC) percentiles. Tumor necrosis factor was not measurable in any serum sample. Serum leukotriene B4 (LTB4) levels were significantly reduced by n-3 fatty acids, mean reduction (-177 pg/mL) compared to n-6 fatty acids (+63 pg/mL) P < 0.05. These results show that both n-3 fatty acids are absorbed and incorporated into platelet phospholipids in patients with CF and reduced serum LTB4. No significant clinical differences or adverse effects were found.

Antibiotic use in the treatment of non-streptococcal pharyngitis.

Treatment of non-streptococcal pharyngitis (NSP) varies among physicians. Recent data regarding difficult-to-culture bacterial pathogens have increased interest in antibiotic treatment of NSP. This study examined physician behavior regarding antibiotic treatment of NSP in preparation for a prospective clinical trial. The records of 358 patients with pharyngitis-related diagnoses from a large private family physician practice and an urban hospital's housestaff clinic were reviewed. No significant relationship between the presence of streptococcus and the prescribing of antibiotics was found. Physicians gave antibiotics to 50% of patients with clinical signs and symptoms of pharyngitis. Many of these tested negative for streptococcus. Physicians used antibiotics effective against Mycoplasma and Chlamydia less than one half of the time. Projected costs of drug treatment for patients with NSP was $1,200. Family medicine educators are encouraged to monitor their own and their residents' antibiotic prescribing behaviors when treating common upper respiratory infections.

Initial selection of oral contraceptives.

A prospective, randomized trial compared client experiences with three popular oral contraceptives--Triphasil, Ortho-Novum 7/7/7 and Ortho-Novum 1/35. After one year, no significant relationship was found between the contraceptive prescribed and either breakthrough bleeding or satisfaction with the medication. The monophasic formulation, Ortho-Novum 1/35, was associated with amenorrhea more often.

PIP: Differences in breakthrough bleeding, amenorrhea, and patient compliance among users of monophasic (Ortho-Novum 1/35) and triphasic (Triphasil and Ortho-Novum 7/7/7) oral contraceptives (OCs) were investigated in a prospective study at a Michigan family planning clinic. 377 (79%) of the women originally enrolled in the study completed the 1-year study period. There was no association between failure to return to the clinic at the required intervals and type of OC prescribed. The percentage of women experiencing breakthrough bleeding in their 1st year of use was 18.4% among Ortho-Novum 7/7/7 users, 17.8% among Ortho-Novum 1/35 users, and 11.2% among Triphasil users; the percentages of women reporting amenorrhea were 3.0%, 12.8%, and 0.0%, respectively. The degree of patient satisfaction was 82.8% for Ortho-Novum 7/7/7, 90.7% for Ortho-Novum 1/35, and 85.2% for Triphasil. No significant correlations were detected between age, weight, or height and the 3 variables under investigation. These findings indicate that Ortho-Novum 1/35, the monophasic formulation, is more frequently associated with amenorrhea than the triphasic OCs and that Triphasil seems to be most efficient in terms of establishing regular, dependable menstrual periods. However, neither breakthrough bleeding nor patient satisfaction were related to the brand of OC prescribed.

Instruction in research-related topics in U.S. and Canadian medical schools.

The authors conducted a study to collect information on the teaching of research-related topics at medical schools. A questionnaire was developed and mailed to appropriate administrators of all accredited United States, Canadian, and Puerto Rican medical schools that asked for information on courses offered in epidemiology, statistics, evaluation of medical literature, and research design. Ninety-seven percent of the medical schools responded to the questionnaire. All but one of the 139 respondents reported offering formal instruction in at least one of the four topics; epidemiology and statistics were offered by 98 percent and 96 percent, respectively, of the responding schools. Training in evaluating medical literature was required by slightly less than half of the responding schools, and research methodology was required by one-third. Future studies should evaluate the effectiveness of such courses.

A radiographic comparison of prehospital cervical immobilization methods.

Three methods of prehospital cervical immobilization were studied radiographically and compared to the short board technique (SBT). The methods were California Stif-Neck Immobilizing Collar (CSC), Kendrick Extrication Device (KED), and Extrication Plus-One (XP-One). Forty-five volunteers were immobilized in the short board (SB) and one of the test devices studied. Cervical movement in the sagittal and frontal planes was measured radiographically. Movement in the horizontal plane was measured directly. Two-tailed, paired t test analysis was performed comparing test devices to the SBT. The SBT proved to be significantly better (P less than .05) in the following comparisons: the CSC in extension and lateral bending; the KED in lateral bending; and the XP-One in extension. We confirm the SBT as the standard of comparison against which newer prehospital devices can be compared objectively. Of the three devices compared against the SBT, the factory-fabricated short board devices (KED and XP-One) provided the greatest degree of immobilization, in addition to logistical advantages over the SBT.

A multicenter validation of the prehospital index.

The prehospital index (PHI) is a triage-oriented trauma severity scoring system. This prospective multicenter validation of the PHI was undertaken in response to a favorable pilot study. We applied the PHI to 3,581 patients from 14 different institutions during the period from January 1985 to February 1986. The PHI was accurate in predicting the need for emergency life-saving surgery within four hours (P less than .0001) and mortality within 72 hours (P less than .0001) following traumatic injury. The curves were generated for PHI versus emergency surgery, mortality, surgery and mortality, injury severity score, and ICU admission rate. These data compare favorably with those from previously published, prospectively tested, triage-oriented trauma severity scoring systems.

Prehospital Index: a scoring system for field triage of trauma victims.

The Prehospital Index (PHI) is a triage-oriented trauma severity scoring system comprising four components: systolic blood pressure, pulse, respiratory status, and level of consciousness, each scored 0 to 5. The PHI was developed after analysis of 313 cases to provide an objective prehospital scoring system for distinguishing less seriously injured patients (minor trauma) from those patients who are likely to die within 72 hours after injury or who require general or neurosurgical operative intervention within 24 hours (major trauma). A PHI of 0 to 3 indicated minor trauma, and a PHI of 4 to 20 signified major trauma. Retrospective analysis of an additional 465 consecutive trauma cases revealed that patients with a PHI of 0 to 3 (minor trauma) had a 0% mortality and a 2% rate of general or neurosurgical operative intervention. Those with a PHI of 4 to 20 (major trauma) carried a 16.4% mortality and an emergency operative rate of 49.1%. The PHI was applied prospectively to 388 consecutive trauma cases presenting to the Butterworth Hospital Emergency Department from October through December 1984. Of the 351 patients scored as minor trauma in the field, there was a 0% mortality and only a 0.3% operative rate. Those scored as major trauma in the field had a mortality of 27% (PHI 4 to 7, 0%; PHI 8 to 20, 53%) and an operative rate of 40.5% (PHI 4 to 7, 22%; PHI 8 to 20, 57.9%). These data demonstrate the ability of the PHI to predict mortality (P less than .001) and the need for emergency general or neurosurgical operative intervention (P less than .001).(ABSTRACT TRUNCATED AT 250 WORDS)