Qualitative research has the potential to contribute important new knowledge to care near the end of life, but research is often hampered by questions about how best to protect dying patients and their family members who serve as research subjects. Due to lack of familiarity with the techniques of ethnographic or observational research, as well as concerns about the vulnerability of the dying, members of Institutional Review Boards (IRBs) are often unable to evaluate the benefits and potential harms of studies. In addition, policies derived from standards based on interventional medical research or clinical trials may be applied inappropriately. We offer comprehensive recommendations aimed at improving the translation of human subjects guidelines into meaningful protections for subjects in qualitative studies, including education for IRBs. Policies must be flexible and should be guided by empirical findings documenting the actual impact of research participation, rather than a priori assumptions about patient vulnerability. Sensitive topics, such as drug use, may require added protections

Objective: To understand fundamental attitudes towards patient safety culture and ways in which attitudes vary by hospital, job class, and clinical status.

Design: Using a closed ended survey, respondents were questioned on 16 topics important to a culture of safety in health care or other industries plus demographic information. The survey was conducted by US mail (with an option to respond by Internet) over a 6 month period from April 2001 in three mailings.

Setting: 15 hospitals participating in the California Patient Safety Consortium.

Subjects: A sample of 6312 employees generally comprising all the hospital’s attending physicians, all the senior executives (defined as department head or above), and a 10% random sample of all other hospital personnel. The response rate was 47.4% overall, 62% excluding physicians. Where appropriate, responses were weighted to allow an accurate comparison between participating hospitals and job types and to correct for non-response.

Main outcome measures: Frequency of responses suggesting an absence of safety culture ("problematic responses" to survey questions) and the frequency of "neutral" responses which might also imply a lack of safety culture. Responses to each question overall were recorded according to hospital, job class, and clinician status.

Results: The mean overall problematic response was 18% and a further 18% of respondents gave neutral responses. Problematic responses varied widely between participating institutions. Clinicians, especially nurses, gave more problematic responses than non-clinicians, and front line workers gave more than senior managers.

Conclusion: Safety culture may not be as strong as is desirable of a high reliability organization. The culture differed significantly, not only between hospitals, but also by clinical status and job class within individual institutions. The results provide the most complete available information on the attitudes and experiences of workers about safety culture in hospitals and ways in which perceptions of safety culture differ among hospitals and between types of personnel. Further research is needed to confirm these results and to determine how senior managers can successfully transmit their commitment to safety to the clinical workplace.

We previously identified viable Helicobacter pylori in stools from asymptomatic hosts. We now report whether a decrease in gastric acidity enhances faecal shedding. Sixteen asymptomatic H. pylori-positive patients underwent two separate days of phosphosoda-induced diarrhoea, both with normal gastric acidity and under hypochlorhydric conditions induced with the H2-blocker cimetidine. Stool samples were collected for culture to determine the presence of viable H. pylori. Five of the 16 patients gave positive cultures with at least one stool from both normal pH and cimetidine-induced hypochlorhydria. Four were negative for all samples with both. Six gave positive stools only after cimetidine treatments, while one gave positive samples with normal pH but not with cimetidine (two-tailed P value, 0.13; McNemar test). These numbers show a trend suggesting that cimetidine-induced hypochlorhydria increases shedding of viable H. pylori.

OBJECTIVE: The prevalence of type 2 diabetes, especially in developing countries, has grown over the past decades. We performed a controlled clinical study to determine whether a community-based, group-centered public health intervention addressing nutrition and exercise can ameliorate glycemic control and associated cardiovascular risk factors in type 2 diabetic patients in rural Costa Rica.

RESEARCH DESIGN AND METHODS: A total of 75 adults with type 2 diabetes, mean age 59 years, were randomly assigned to the intervention group or the control group. All participants received basic diabetes education. The subjects in the intervention group participated in 11 weekly nutrition classes (90 min each session). Subjects for whom exercise was deemed safe also participated in triweekly walking groups (60 min each session). Glycosylated hemoglobin, fasting plasma glucose, total cholesterol, triglycerides, HDL and LDL cholesterol, height, weight, BMI, and blood pressure were measured at baseline and the end of the study (after 12 weeks).

RESULTS: The intervention group lost 1.0 +/- 2.2 kg compared with a weight gain in the control group of 0.4 +/- 2.3 kg (P = 0.028). Fasting plasma glucose decreased 19 +/- 55 mg/dl in the intervention group and increased 16 +/- 78 mg/dl in the control group (P = 0.048). Glycosylated hemoglobin decreased 1.8 +/- 2.3% in the intervention group and 0.4 +/- 2.3% in the control group (P = 0.028).

CONCLUSIONS: Glycemic control of type 2 diabetic patients can be improved through community-based, group-centered public health interventions addressing nutrition and exercise. This pilot study provides an economically feasible model for programs that aim to improve the health status of people with type 2 diabetes.

Objective: To test the feasibility, acceptability, and potential efficacy of after-school dance classes and a family-based intervention to reduce television viewing, thereby reducing weight gain, among African-American girls.

Design: Twelve-week, 2-arm parallel group, randomized controlled trial.

Setting: Low-income neighborhoods.

Participants: Sixty-one 8-10-year-old African-American girls and their parents/guardians.

Interventions: The treatment intervention consisted of after-school dance classes at 3 community centers, and a 5-lesson intervention, delivered in participants' homes, and designed to reduce television, videotape, and video game use. The active control intervention consisted of disseminating newsletters and delivering health education lectures.

Main Outcome Measures: Implementation and process measures, body mass index, waist circumference, physical activity measured by accelerometry, self-reported media use, and meals eaten with TV.

Results: Recruitment and retention goals were exceeded. High rates of participation were achieved for assessments and intervention activities, except where transportation was lacking. All interventions received high satisfaction ratings. At follow up, girls in the treatment group, as compared to the control group, exhibited trends toward lower body mass index (adjusted difference = -.32 kg/m2, 95% confidence interval [CI] -.77, .12; Cohen's d = .38 standard deviation units) and waist circumference (adjusted difference = -.63 cm, 95% CI -1.92, .67; d = .25); increased after-school physical activity (adjusted difference = 55.1 counts/minute, 95% CI -115.6, 225.8; d = .21); and reduced television, videotape, and video game use (adjusted difference = -4.96 hours/week, 95% CI -11.41, 1.49; d = .40). The treatment group reported significantly reduced household television viewing (d = .73, P = .007) and fewer dinners eaten while watching TV (adjusted difference = -1.60 meals/week, 95% CI -2.99, -.21; d = .59; P = .03). Treatment group girls also reported less concern about weight (d = .60; P = .03), and a trend toward improved school grades (d = .51; P = .07).

Conclusions: This study confirmed the feasibility, acceptability, and potential efficacy of using dance classes and a family-based intervention to reduce television viewing, thereby reducing weight gain, in African-American girls.

Objective: Most infections occur during childhood, but the health effects of childhood infection are poorly understood. We investigated whether growth decreases in the 2 months after acute seroconversion.

Methods: We performed a nested case-control study among children 6 months to 12 years of age in a community on the outskirts of Lima, Peru. Health interviews were completed daily. Anthropometric measurements were taken monthly. Sera were collected every 4 months and tested for immunoglobulin G. Two-month height and weight gains of seroconverters were compared with gains of sex, age, and size-matched seronegative controls.

Results: In the 2 months after infection, 26 seroconverters gained a median of 24% less weight than 26 matched controls (interquartile range, 63% less to 21% more). In multivariate analysis, infection attenuated weight gain only among children aged 2 years or older. This decrease was not explained by increased diarrhea.

Conclusions: Seroconversion is associated with a slowing of weight gain in children aged 2 years or older. Reasons for this finding merit additional study.