SEARCH · PubMed Health

Results for “Minnesota Health Data Institute”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 73 records · Page 4Linked to original sources

PubMed2006

Comparing rural-trained medical students with their peers: performance in a primary care OSCE.

BACKGROUND: Although it is well-established and considered successful, there is limited data on how the graduates of a Minnesota rural medical education program (Rural Physician Associate Program [RPAP]) compare with their peers. PURPOSE: To compare the performance of RPAP students with their peers on a primary care observed structured clinical examination (OSCE). METHODS: The performances of RPAP students and a group of non-RPAP Year 4 medical students were compared on the same OSCE. RESULTS: RPAP students performed at least as well as their peers on stations assessing performance on common primary care clinical scenarios but not as well on a small number of stations that assessed applied knowledge of specific content taught in the traditional clerkship curriculum. CONCLUSIONS: We provide evidence that rurally trained students at this institution performed at least as well as their peers on OSCE stations testing performance in common primary care scenarios. The broader implications of this study are that medical students may receive high-quality training in rural communities, as documented by their performance on an objective structured clinical examination.

Adult↗

PubMed1997

Recommendations for chemoprophylaxis after occupational exposure to human immunodeficiency virus: a public health agency perspective.

Public health agencies across the country uniformly retain three core functions, as identified in a 1988 Institute of Medicine report: assessment, assurance, and planning and policy development. The conduct of these functions will influence the ways the Public Health Service recommendations for postexposure prophylaxis are implemented locally. State, territorial, and local health departments play a key role in the monitoring and prevention of occupationally acquired human immunodeficiency virus (HIV) infections. Through assessment, public health agencies often are responsible for investigating healthcare workers who apparently have contracted HIV infection through an occupational exposure. In their function of providing assurance, public health agencies disseminate the national recommendations and may provide expert consultation taking into consideration local conditions. Specific healthcare worker exposure situations may pose complex medical and legal challenges best handled by public health agencies. In their role of providing policy development, public health agencies may convene an expert panel to review local data that affect postexposure prophylaxis, such as antiretroviral drug resistance and drug availability. The recommendations may result in legislative action in the form of mandatory testing of patients or other groups, and public health agencies must be wary of such attempts that are of unproven efficacy. Public health agencies nationwide must see that exposed healthcare workers and the clinicians counseling them are adequately informed about the risks of HIV transmission and the options available for prophylaxis.

Anti-HIV Agents↗

PubMed1999

Factors affecting use of chiropractic services in seven midwestern states of the United State.

Although chiropractic is used by approximately 10 percent of the U.S. population, predictors of its use have not been definitively described. Previous studies have suggested that chiropractic users differ from nonusers in a number of sociodemographic characteristics, but their findings are inconsistent, perhaps because of differences in populations sampled and dates of data collection, most of which are prior to 1990. Regional studies have been conducted in rural areas based on the premise that rural residents are more likely than non-rural residents to use chiropractice; however, this premise has not been definitively documented. The purpose of this study was to provide clarification of these sociodemographic predictors of chiropractic use in Illinois, Iowa, Minnesota, Missouri, Nebraska, South Dakota and Wisconsin by characterizing chiropractic users and nonusers in terms of sociodemographics, including rural or non-rural residence, and presence of low back pain. Data from 1,511 respondents to a 1994 population-based survey, conducted by the University of Iowa Social Science Institute, were analyzed. Unconditional logistic regression was used to derive odds ratios and 95 percent confidence intervals for univariate and multiple regression models. Overall, 15.1 percent of respondents had used chiropractic within the last year, most often for low back pain (57 percent). Chiropractic use was less likely in African Americans, Hispanics and Asians than whites, less likely by non-rural than rural residents, and less likely in Catholics than Protestants in states other than Iowa and South Dakota. Overall, 42.7 percent of workers with low back pain reported using chiropractic, and use increased with age but remained significantly related to race, rural or non-rural residence, state of residence and religious preference. Race, rural or non-rural residence, state of residence and religious preference, independently of low back pain, affect use of chiropractice in seven Midwestern states.

Adult↗

PubMed2004

Quality of life in 650 lung cancer survivors 6 months to 4 years after diagnosis.

OBJECTIVE: To present the results of a quality-of-life (QOL) assessment performed with the current version of the Lung Cancer Symptom Scale (LCSS) questionnaire in a large single-institutional data set of 650 patients with lung cancer. PATIENTS AND METHODS: The study group included 650 patients with pathologically confirmed primary lung cancer whose conditions were diagnosed and/or treated at the Mayo Clinic in Rochester, Minn, between January 1, 1997, and December 31, 2001. The QOL assessment was performed using the self-administered LCSS questionnaire (version 2) 6 months to 4 years after the diagnosis of lung cancer. RESULTS: The item response rate for all 9 LCSS questions was 94.2% with a minimum of 92.9%. Significant differences in overall QOL by sex (P=.04), Karnofsky scale (P<.001), weight loss (P<.001), disease stage (P<.001), and histology (P=.001) were found, but no significant differences in overall QOL by age (P=.17) or marital status (P=.06) were observed. CONCLUSION: Our data suggest that QOL in patients with lung cancer at varying times after diagnosis highly correlates with baseline prognostic factors (disease stage, histology, Karnofsky scale, weight loss, and sex).

Adult↗

PubMed1997

Medical claims profiles of subjects with temporomandibular joint disorders.

The primary goal of this study was to evaluate the claims profiles of subjects with TMJ disorders relative to a control group without the disorders and to provide a characterization of the type of healthcare services received and the associated costs of healthcare for patients with TMJ disorders. The administrative data base of a major medical insurer was used to compare the claims history of 1,819 patients diagnosed with TMJ disorders to matched controls. The analysis was based only on medical claims. The study found that total medical claim payments for the patients with TMJ disorders were double that of the subjects without TMJ disorders, and similarly, the utilization of institutional and professional care services was found to be approximately twice as high, though not uniformly distributed across all Major Diagnostic Categories, physician specialties or types of service. The level and nature of the differences in the quantity and costs of healthcare between subjects with and without TMJ disorders were unexpectedly large. The majority of these differences were attributed to conditions that were not usually considered related to TMJ disorders. These utilization and cost differences extended, in varying degrees, over a wide range of diagnostic and healthcare provider categories.

Adolescent↗

PubMedDate not supplied

Health problems in a city-county workhouse.

This study was part of a continuing effort to define the health profile of a city-county workhouse inmate population. To supplement data previously obtained on the health status of inmates on admission, all subsequent encounters for medical problems were recorded and analyzed. Of 491 inmates examined on admission, 312 subsequently made 1,257 visit for medical care. The rate of clinic use was two to three times higher than rates reported in national surveys. Of 1,549 problem encounters, trauma, musculoskeletal complaints, skin disorders, and diseases of the eyes, ears, nose, and throat accounted for 52.3 percent. Dental disease, trauma, and other musculoskeletal disorders comprised 66.3 percent of problems that required referral of patients to the city-county hospital. A significant relationship was seen between depression as determined by a self-rating questionnaire and numbers of visits and problem encounters, as well as several frequently encountered problems. The results of this study have implications for health services in correctional institutions with similar inmate populations. The provision of limited but onsite dental services is advisable. Athletic activities and work details should be closely supervised. Physicians and nurses should be skilled in the evaluation and management of minor trauma and other musculoskeletal disorders. Algorithms are appropriate aids in the management of common but minor medical problems. These measures and proposals are designed also to deal with the problem of overuse of clinic services. However, the measures do not diminish and, in some instances, they increase access to care for medical and dental health needs.

Adolescent↗

PubMed1999

Physician risk assessment and APACHE scores in cardiac care units.

BACKGROUND: The need to correct outcome data for case mix is well recognized, but risk assessment for coronary care unit (CCU) patients remains problematic. HYPOTHESIS: This study determined the feasibility of using physicians' opinions to predict mortality for CCU patients and compared their results to Acute Physiology and Chronic Health Evaluation II (APACHE II) scores. METHODS: A prospective observational study was performed on consecutive patients admitted to a university-affiliated Veterans Affairs Medical Center CCU over a 2-month period. Physician assessment of likely mortality during hospitalization, obtained using an MD Prognosis Score ranging from 1 (best) to 7 (worst), was compared with APACHE II scores. RESULTS: MD Prognosis Scores were obtained on 122 of the 237 eligible patients (51% response rate) and averaged 2.3 +/- 1.4 (mean +/- standard deviation). APACHE II scores on these patients averaged 9.9 +/- 4.8 (range 2-29) with very poor correlation between the two methods (r = 0.3). Of the four patients who died, three had MD prognosis scores of 7. None of the survivors had scores of 7 and only three had scores of 6. APACHE II did not predict a high likelihood that any of the patients would die (none with > 90% likelihood of mortality). CONCLUSIONS: APACHE scores are inadequate for cardiac patients. Although physicians can identify CCU patients most likely to die, reliance on physician scoring systems is limited by difficulties in obtaining their opinion. A new method of risk assessment for acutely ill cardiac patients is needed if CCU outcomes are to be compared across institutions.

APACHE↗

PubMed1992

The Olmsted County Benchmark Project: primary study findings and potential implications for corporate America.

Since 1965, expenditures for medical care in the United States have increased 10-fold. As a result, corporate outlays for health benefits have skyrocketed. Employers have instituted various cost-containment measures based in part on reports of wide variations in rates of utilization and the assumption that unnecessary or inappropriate utilization of medical care contributes to increasing costs. Frequently, however, employers lack adequate means for identifying sources of variation or for evaluating its appropriateness. In this article, we report on a project in which hospital utilization among several US corporate populations was compared with that for a geographically defined benchmark population to assist employers in the assessment of their rates of utilization and expenditures and to identify specific areas that merit further investigation. Our findings illuminate the difficulties in constructing valid rates from medical-care claims data and emphasize potential biases due to problems of comparability between populations. We also address the potential value of such comparison for helping corporations identify areas in which cost-containment efforts may be most effective and yet not jeopardize the quality of medical care.

Adolescent↗

PubMed1977

25 years of neuroepidemiology in the Americas.

In the Western Hemisphere, prior to 1950, there were few reliable data on the incidence, geographic distribution or population patterns of diseases of the nervous system. Impressions of prevalence were generally derived from the European literature and from a variety of case reports and relative frequencies based on clinic or hospital admissions or selected autopsy series. Since such data from different sources generally defy comparison, it has been necessary to develop data sources for defined populations to provide incidence and prevalence rates. Such an effort, initially concerned with multiple sclerosis, was launched in 1950 by NIH. International mortality statistics were also collected and analyzed and intensive population surveys in the United States and Canada were planned and carried out. In time, such efforts were extended to cover a wide variety of other chronic and subacute diseases of the nervous system, and support was provided by NIH and voluntary agencies for studies in many other countries. Independently, population studies were developed at various Universities and health care facilities in Latin America. ISSSTE in Mexico City provided a broad experience on multiple sclerosis, ALS, epilepsy, stroke and brain tumor; studies developed in the West Indies on Jamaican Neuropathy; and there were studies in several countries on cysticercosis, Chagas' disease and epilepsy. Also notable are recent studies in Guatemala and plans for geographic comparisons over the broad range of latitude in Chile. The advantages and limitations of mortality statistics will be discussed. The priorities in the selection of the disorders which were to be studied, the procedures which were developed, and the highlights of the results of such investigations will be presented. In addition to descriptive population surveys, case control comparisons and prospective studies are also being developed which seek to identify the risk factors or etiologic determinants that may account for the population pattern which have been observed.

Amyotrophic Lateral Sclerosis↗

PubMed1983

The Social Insurance Institution's coronary heart disease study. Baseline data and 5-year mortality experience.

The Social Insurance Institution's Coronary Heart Disease Study is a prospective population study designed to investigate the prevalence, risk factors and incidence of coronary heart disease (CHD) in middle-aged Finnish men and women. The study population consisted of 5 738 men and 5 224 women, aged 30-59 years at entry, drawn from 12 cohorts from south-western, western, central and eastern Finland. The cohorts consisted of whole or random samples of rural or semiurban dwellers or employees of a factory. The participation rate was 90 per cent. The prevalence of symptoms was determined by the Rose questionnaire and abnormalities on resting ECG were coded according to the Minnesota code. Blood pressure, smoking habits, serum cholesterol, triglycerides, postload plasma glucose and obesity were the risk factors analysed at the baseline examination. The mortality of examinees has been followed continuously. This report deals with the main findings at the baseline examination and the mortality follow-up experience in 5 years. The prevalence of typical angina pectoris was 4.4 per cent in men and 5.4 per cent in women. Unequivocal ECG signs of past myocardial infarction were observed in 1.0 per cent of men and 0.3 per cent of women. Other ECG findings suggesting CHD were observed in 9.2 per cent of men and 11.1 per cent of women. The 5-year mortality was 4.3 per cent in men and 0.9 per cent in women. Men with typical chest pain symptoms had a seven-fold risk to die from CHD, compared to men without symptoms. Men with ECG abnormalities compatible with an old infarction had a 19.5-fold and men with other ECG findings suggesting CHD a 7.1-fold risk to die from CHD compared to men without resting ECG abnormalities. Men with ECG findings as the only indicator of CHD had worse survival than men with symptoms as the only indicator of CHD. The value of symptoms and ECG findings as predictors of CHD mortality in women was very low.

Adult↗

PubMed1989

Prevalence of "significant" hypertension in junior high school-aged children: the Children and Adolescent Blood Pressure Program.

Blood pressure (BP) data obtained during a BP screening program were analyzed to determine the prevalence of "significant" hypertension, defined by the Second National Heart, Lung, and Blood Institute Task Force on Blood Pressure Control in Children-1987 as the level of BP above which medical evaluation and intervention are recommended. In 14,686 black and white St. Paul and Minneapolis schoolchildren aged 10 to 15 years, BP was measured twice during an initial screening examination. Children with systolic BP in the upper 30 percentiles of distribution after the initial screening had their BP remeasured two additional times at a rescreening examination. The prevalence of significant hypertension was determined according to BP criteria established by the Task Force report. After the two screening BP measurements were averaged, significant systolic hypertension was found in 1.0%, significant diastolic hypertension in 3.5%, and significant systolic or diastolic hypertension, or both, in 4.2% of the students. After the rescreening examination, the percentage of students remaining with significant hypertension was reduced to 0.3% for systolic, 0.8% for diastolic, and 1.1% for systolic or diastolic hypertension, or both. These results show that significant hypertension is uncommon in pre-high-school students and confirm the need for repeated BP measurements to make an accurate diagnosis of hypertension. However, the results should not detract from current recommendations to monitor BP in children on a yearly basis to detect longitudinal BP tracking patterns that may be consistent with early essential hypertension.

Adolescent↗

PubMed2005

Resource utilization and outcome in gravely ill intensive care unit patients with predicted in-hospital mortality rates of 95% or higher by APACHE III scores: the relationship with physician and family expectations.

OBJECTIVE: To assess resource utilization and outcome in gravely ill patients admitted to an intensive care unit (ICU) and the potential association with health care workers' and family members' expectations. PATIENTS AND METHODS: We retrospectively evaluated ICU patients with a predicted in-hospital mortality rate of 95% or higher (PM95) using the Acute Physiology and Chronic Health Evaluation III (APACHE III) on 2 consecutive days. All patients were admitted to a single institution between September 30, 1994, and August 9, 2001. RESULTS: The APACHE III database contained data from 38,165 ICU patients during the study interval. Of these, 248 (0.65% of ICU admissions) achieved PM95 status and were included in the study. Between PM95 and hospital discharge, resource utilization (eg, blood transfusion, hemodialysis, surgery, and computed tomography or magnetic resonance imaging) was extensive. A total of 23% of patients survived to hospital discharge, yet all but 1 were moderately or severely disabled. One year after achieving PM95, 10% (95% confidence interval, 7%-15%) of patients were alive. For 229 patients, the medical records contained physician documentation that indicated a likely fatal outcome. Thirty-six of these medical records documented unrealistic family expectations of a good outcome. The latter finding correlated with increased resource utilization without significant improvement in 1-year survival. In contrast, absence of physician documentation of a likely fatal outcome In 19 patients correlated with an improved likelihood of hospital (74%) and 1-year (47%) survival. CONCLUSION: Despite better-than-predicted survival outcomes, patient functionality and 1-year survival were poor. Unrealistic family expectations were associated with increased resource utilization without significant survival benefit, whereas absence of physician documentation of likely impending death (which correlated with improved survival) may denote the prognostication skills of experienced clinicians.

APACHE↗

PubMed2001

Assessment of hypercholesterolemia control in a managed care organization.

To determine the extent of achievement of goal low-density lipoprotein cholesterol (LDL) as defined by National Cholesterol Education Program-Adult Treatment Panel II (NCEP-ATP 11) and American Diabetes Association (ADA) 2000 guidelines, we conducted a retrospective study by integrating data from medical, laboratory, and pharmacy claims databases. Subjects were selected from a 232,000-member staff-model managed care organization consisting of 19 clinics in the Minneapolis-St. Paul, Minnesota, metropolitan area. A total of 124,971 members aged 18 years and older, who had been continuously enrolled from July 1, 1996-June 6, 1998, were included. Outcome measures were the extent of achievement of goal LDL as defined by NCEP-ATP II and the use of antihyperlipidemic drugs for patients with and without diabetes at various levels of risk for coronary heart disease (CHD). Of 124,971 subjects, 6538 had a history of CHD, 1523 of whom met their LDL goal. Of the population with CHD who did not achieve goal, 1141 (43%) missed by over 30 mg/dl; 621 (54%) of these patients were not receiving drug therapy A total of 17,267 had no history of CHD but had two or more risk factors; 3,298 of these achieved their LDL goal. Of those who did not achieve goal, 1,136 (35%) missed by over 30 mg/dl; 897 (79%) of these were not receiving drug therapy A total of 6,586 had a history of diabetes; 1,004 and 2,340 reached an LDL of 100 mg/dl or lower and less than 130 mg/dl, respectively Of those with diabetes who had an LDL greater than 100 mg/dl, 1,276 (49%) missed their goal by over 30 mg/dl; 898 (70%) of these were not receiving drug therapy. Inadequate use of pharmacologic agents plays a significant role in failure to achieve goal LDL for patients with CHD, without CHD, and with diabetes. Analysis of the data based on the new ADA guidelines for LDL demonstrates the need for continued vigilance. Finally, the successful merging of medical, laboratory, and pharmacy claims databases provides a benchmark for other institutions.

Adult↗

PubMed1995

Health care delivery reorganization innovative outcome: universal computerized patient identification.

Twenty-three large employers in the Minneapolis/St. Paul area formed the business health care action coalition group (BHCAC) to obtain medical care for their employees and families. Requirements of BHCAC included: 1) detailed reporting of outcomes of both preventive and standard health care, 2) development and successful implementation of practice guidelines, and 3) development of a functioning automated medical record. The coalition was contracted to meet these requirements. A nonprofit foundation--the Institute for Clinical Systems Integration (ICSI)--was formed and the data standards committee created. To ensure registration information transmitted by network would be attached to the correct patient's computer file; a standardized registration data set was agreed upon to be recorded in a uniform manner. This innovative change has allowed, encouraged, and required that clinical data be transferable electronically among organizations. The following are the ICSI data standard requirements for ICSI member organizations: the Health Level 7 (HL7) is to be used for data transmission [1]. Fields to be used include: 1) Social Security Number (SSN): The SSN was chosen as the patient identifier for the reasons listed in [2]. Record the official SSN assigned by the Social Security Administration; record a pseudo-SSN if a social security number is not available following the Veterans Administration (VA) Hospital algorithm. 2) Name: Use the American National Standards Institute (ANSI) Healthcare Informatics Standards Planning Panel (HISPP) and Message Standards Developers Subcommittee (MSDS) Standard for representation of a person's name [3]; completely record all of the person's legal name (including any punctuation, hyphenated and double last names); nicknames and appellations are to be recorded separately; salutations and suffixes are optional, but must be placed in separate computer fields from other name parts. 3) Gender: Allowable values include FEMALE, MALE, OTHER, UNKNOWN. 4) Date of Birth: Include the day, month, year (including century); permitted is approximate or estimated birth dates provided they are indicated as such. Use the ANSI HISPP MSDS standard for date representation [4]. 5) Address: Record at least one address; multiple addresses desirable identified by type or usage (i.E., home, business, office). Allow two or more lines for street, city, U.S. state or Canadian Province; identify by standard two-letter postal abbreviation--zip code (at least 5-digits, preferably 9) or postal code and country. 6) Home ID or Medical Record Number (MRN): Record if different than Social Security Number.

Female↗

PubMed1993

Background, conceptualization and design of a community-wide research program on adolescent alcohol use: Project Northland.

Project Northland is a community-wide research program funded by the National Institute on Alcoholism and Alcohol Abuse, for a 5-year period (1990-95). The aim of the study is to prevent or delay onset of alcohol use among young adolescents, as well as to reduce use among those who are already drinkers. Twenty communities were recruited in northeastern Minnesota, an area referred to as the Northland, Arrowhead or Iron Range region, and then were randomly assigned to either Education or Delayed Program conditions. The 10 Education school districts have agreed to participate in 3 years of intervention programs in schools, with parents and in the community-at-large. One group of young adolescents, the Class of 1998 (sixth grade students in the 1991-92 school year), form the study cohort. Surveys (1991-94) of the Class of 1998, their parents, community leaders and alcohol merchants are the primary components of the program's evaluation. Many conceptual and methodological questions emerged during the development of the research protocols for Project Northland over the past 2 years. These questions are the impetus for this article. Specifically, the focus on young adolescents and alcohol use was selected, as contrasted with older adolescents or with multiple problem behaviors. The project was designed using a community-wide model that addresses both supply and demand issues, rather than limited to a school-based model. Intervention strategies and evaluation methods were chosen that could address community-level as well as individual-level behavior change, which required the development and application of new technologies. The rationale for these decisions may be useful to others considering community-wide health promotion efforts.

Adolescent↗

PubMed1989

A report from the NIDDK Liver Transplantation Database.

The development and pilot phase of the NIDDK LTD project has been successfully completed by recruiting and uniformly evaluating at baseline and follow-up of 176 candidates and 101 transplant patients from 5 LTD Clinical Centers (Baylor University Medical Center, Mayo Clinic, University of California at Los Angeles, University of Minnesota, and University of Pittsburgh). The first set of analyses presented in this report describes the characteristics of the candidates, recipients and donors who were enrolled in the LTD pilot study. Other findings must be regarded as trends until more data become available. Candidates who presented with fulminant or subacute liver failure as well as those with lupoid type chronic active hepatitis had the highest selection rate for transplantation while those with malignancy and alcoholic cirrhosis had the lowest. Overall, little selection occurred on the basis of age alone. Early posttransplantation recovery characterized by prolonged ICU stay, or by death or retransplantation in the ICU, were significantly influenced by operative and recipient factors. Generally, when function of other organ systems was impaired, the event rates were higher. Abnormal neurological status represented the greatest risk. For the ICU course, patients with fulminant disease fared the worst and cirrhotics the best. Long operation (greater than 8 hrs) and blood use in excess of 3,000 ml had 2-3 times the risk for long ICU stay or adverse ICU events. Surprisingly, donor and harvesting factors also played a significant role in the early posttransplantation course. Such trends were shown for drug abuser donors and for rapid hepatectomy time. The harvesting surgeon's assessment of the donor and the graft had good predictive value of the ICU course. Finally, patients who required retransplantation within 6 weeks more often had donors with histories of longer hospitalization and fewer grafts that were deemed excellent or good at harvest.

Databases, Bibliographic↗

PubMed2000

Creatine use among a select population of high school athletes.

OBJECTIVE: To determine the prevalence, frequency, and patterns of creatine use among a local population of high school athletes. SUBJECTS AND METHODS: Male and female high school athletes completed an anonymous questionnaire on creatine use during the August 1999 preparticipation examinations at a single institutional sports medicine center. RESULTS: A total of 328 students (182 males and 146 females) aged 14 to 18 years (mean +/- SD 15.2 +/- 1.3 years) completed the survey (100% response rate), although not all athletes answered each question. Twenty-seven athletes (8.2% of total group), 1 of whom was female, reported creatine use. Of these 27 athletes, 14 (52%) were taking creatine at the time of the survey. The frequency of creatine use among past and current users was equally distributed among rarely (30%), weekly (35%), and daily (35%). Creatine users were older than nonusers (mean 16.5 +/- 1.2 vs 15.0 +/- 1.3 years; P < .001). Of creatine users, 21 (78%) were male football players. Nineteen of 24 respondents (79%) believed creatine improved their performance. Overall, 78% of users either did not know how much creatine they were taking (12/22 respondents) or were taking greater than the recommended doses (5/22 respondents). Minor gastrointestinal side effects or muscle cramps were reported by 5 (20%) of 25 respondents. Creatine users were more likely than nonusers to know other creatine users (81% vs 22%; P < .001) and to use other supplements (67% vs 9%; P < .001). Creatine users obtained creatine information primarily from friends (74%) and purchased creatine predominantly from health food stores (86%). CONCLUSIONS: High school male and female athletes as young as 14 years use creatine. Of high school athletes participating in our study, 8.2% reported creatine use. Relatively minor side effects, diarrhea, cramps, and loss of appetite, were reported. Creatine users seem to believe that creatine improves their performance, but they may lack sufficient information to make informed decisions regarding creatine use. Further larger scale study is warranted.

Adolescent↗

PubMed1999

An approach to community consultation prior to initiating an emergency research study incorporating a waiver of informed consent.

OBJECTIVES: In November 1996, the Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS) enacted rules allowing a narrow exception to the requirement for prospective informed consent when enrolling critically ill patients in clinical research studies of emergency treatments. These rules require that, prior to initiation of the study, the applicable institutional review board (IRB) assess the acceptability of the proposed research study to members of the community in which the research will be conducted. Specifically, the IRB must perform community consultation-a process during which community members learn about the proposed research and communicate their opinions regarding its acceptability to investigators or IRB representatives. The FDA and DHHS rules do not define specific acceptable methods for performing this community consultation. The objective of this study is to demonstrate the feasibility and utility of one proposed method for performing such community consultation. METHODS: Parents of children being seen for minor traumatic injuries in three pediatric EDs were asked to participate in a study regarding informed consent. After consent, an instructor described to the parent a prospective, randomized, placebo-controlled trial of phenytoin for the prophylaxis of posttraumatic seizures in children with severe closed head trauma. All parents were then asked whether they would have consented for their own child's participation, if their child had suffered such head injury. The parents were further asked to explain the reason(s) for their responses. RESULTS: Parents of 227 children (children's mean +/- SD age 8.0 +/- 4.8 years, 57% male) were interviewed. Sixty-six percent of parents (149/227) stated they would give consent for their child's participation. Of the 149 consenting parents, 85% (126/149) cited potential benefit to their child, 72% (107/149) cited potential benefit to other children, and 60% (90/149) cited furthering medical knowledge. Of the 78 nonconsenting parents (34% of total), 54% (42/78) cited fear of adverse effects, 39% (30/78) did not want their child to be a research subject in general, 27% (21/78) believed they needed to discuss participation with family members who were unavailable, and 26% (20/78) stated they were unable to decide unless they were in the actual situation. Parental ethnicity and household income were found to influence the consent decision, while the parent's gender, religion, language, and educational level were not associated with the consent decision. CONCLUSIONS: Community consultation regarding the acceptability of an emergency research protocol can be obtained via interview techniques in the ED. This methodology may allow investigators to obtain data on opinion from a targeted community for IRB consideration during the review of emergency research studies proposing a waiver of informed consent.

Adult↗