Factors That Influence Women's Decisions About Whether to Participate in Research: An Exploratory Study

Abstract: Background : Women are increasingly being asked to consider participating in medical research. We sought to investigate views of women who participated in and declined to participate in a study that was part of a program of maternity care research. Methods : An exploratory study using focus group interviews and semistructured interviews was conducted. A purposive sample of 17 postnatal women who had participated in research, from a hospital in the North West of England, were interviewed. An open coding mechanism to identify emergent themes was used for the analysis of data. Results : Of women who had not declined to participate in any research, the following themes were identified: altruism versus self‐protection, enhanced versus inferior care, professional guidance versus self‐direction, and welcome versus unacceptable methodology. Of women who had participated in some research but declined to participate in other research, the following themes were identified: feeling disempowered by the process, inability to believe equipoise existed, and practical inconvenience. Conclusions : These findings suggest that although health care researchers adopt an individualistic approach to care, they may fail to adopt a similar approach within research. What is important and acceptable to women needs to be ascertained to develop appropriate research strategies. This plan will ensure that research is carried out to the highest ethical standard, which may increase recruitment rates.     

Phase I and pharmacokinetic study of gefitinib in children with refractory solid tumors: a Children's Oncology Group Study.

PURPOSE: Epidermal growth factor receptor is expressed in pediatric malignant solid tumors. We conducted a phase I trial of gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor, in children with refractory solid tumors. PATIENTS AND METHODS: Gefitinib (150, 300, 400, or 500 mg/m2) was administered orally to cohorts of three to six patients once daily continuously until disease progression or significant toxicity. Pharmacokinetic studies were performed during course one (day 1 through 28). RESULTS: Of the 25 enrolled patients, 19 (median age, 15 years) were fully evaluable for toxicity and received 54 courses. Dose-limiting toxicity was rash in two patients treated with 500 mg/m2 and elevated ALT and AST in one patient treated with 400 mg/m2. The maximum-tolerated dose was 400 mg/m2/d. The most frequent non-dose-limiting toxicities were grade 1 or 2 dry skin, anemia, diarrhea, nausea, and vomiting. One patient with Ewing's sarcoma had a partial response. Disease stabilized for 8 to > or = 60 weeks in two patients with Wilms' tumor and two with brainstem glioma (one exophytic). At 400 mg/m2, the median peak gefitinib plasma concentration was 2.2 microg/mL (range, 1.2 to 3.6 microg/mL) and occurred at a median of 2.3 hours (range, 2.0 to 8.3 hours) after drug administration. The median apparent clearance and median half-life were 14.8 L/h/m2 (range, 3.8 to 24.8 L/h/m2) and 11.7 hours (range, 5.6 to 22.8 hours), respectively. Gefitinib systemic exposures were comparable with those associated with antitumor activity in adults. CONCLUSION: Oral gefitinib is well tolerated in children. Development of the drug in combination with cytotoxic chemotherapy will be pursued.     

Low-molecular weight heparin for deep vein thrombosis prophylaxis in hospitalized medical patients: results from a cost-effectiveness analysis.

Multiple options exist for the prevention of deep vein thrombosis (DVT) in medical inpatients. We sought to determine the cost-effectiveness of low-molecular-weight heparin (LMWH) relative to unfractionated heparin (UFH) for DVT prevention in this setting. We conducted a cost-effectiveness analysis from the perspective of a third-party payer employing a decision model and literature-based estimates for inputs. In the base-case analysis, LMWH had little impact on the rate of DVT. Despite higher acquisition costs, however, LMWHs resulted in net savings. Routine use of LMWH saves approximately US$89 per patient. The lower rate of heparin-induced thrombocytopenia (HIT) with LMWH accounted for this differential. Univariate sensitivity analysis revealed the model was moderately sensitive to the odds ratio of HIT with LMWH and the cost of HIT. Multivariate sensitivity analysis confirmed the LMWH approach dominated financially. 'Worst-case' scenario modeling, where LMWH actually increased the risk for DVT, had little effect on the rate of HIT, and was substantially more costly than UFH, still demonstrated that LMWHs were economically superior. Monte-Carlo simulation indicated the 95% confidence interval around the estimate for savings with LMWH ranged from US$7 to US$373. We conclude that, despite their higher cost, LMWHs for thromboprophylaxis in medical patients result in savings.     

Extended spectrum beta lactamase-producing Klebsiella pneumoniae infections: a review of the literature.

Infections caused by extended-spectrum beta-lactamase (ESBL)-producing pathogens, particularly Klebsiella pneumoniae, are increasing. The epidemiology of ESBL-producing K. pneumoniae, the mechanisms of resistance, and treatment strategies for infections caused by these organisms are reviewed.     

Modeling the effects of health status and the educational infrastructure on the cognitive development of Tanzanian schoolchildren.

This paper models the proximate determinants of school attendance and scores on cognitive and educational achievement tests and on school examinations of over 600 schoolchildren from the Control group of a randomized trial in Tanzania, where children in the Intervention group heavily infected with hookworm and schistosomiasis received treatment. The modeling approach used a random effects framework and incorporated the inter-relationships between school attendance and performance on various tests, controlling for children's health status, socioeconomic variables, grade level, and the educational infrastructure. The empirical results showed the importance of variables such as children's height and hemoglobin concentration for the scores, especially on educational achievement tests that are easy to implement in developing countries. Also, teacher experience and work assignments were significant predictors of the scores on educational achievement tests, and there was some evidence of multiplicative effects of children's heights and work assignments on the test scores. Lastly, some comparisons were made for changes in test scores of treated children in the Intervention group with the untreated children in the Control group.     

An analysis of injury rates after the seasonal change in rugby league.

OBJECTIVES: To determine whether the increase in the incidence of injury found for the first summer season in which rugby league (RL) was played in the UK was repeated in subsequent summer seasons. DESIGN: A retrospective and prospective cohort study design. SETTING AND PARTICIPANTS: Injuries were recorded from all players who took part in 141 games over 3 summer seasons (1997 to 1999) for 1 professional team. These were compared against rates from previously collected data for 3 earlier winter and 1 summer season. ASSESSMENT OF RISK FACTORS: For each injury it was recorded in which season it occurred; how many games or training sessions, if any, were subsequently missed; the type, site and severity of injury. MAIN OUTCOME MEASURES: Injuries were reported as rate per 1000 hours, also broken down into severity according to the number of games missed and whether subsequent training sessions were missed. RESULTS: A sustained increase in injury incidence has been found comparing summer RL over RL played in the winter. There was an increase in injury rates for all sites and types, but not all reached significance. CONCLUSIONS: Data collected over 6 seasons indicate a higher risk of sustaining an injury playing summer RL, but the cause may be related to a combination of factors. These may include the ground or weather conditions associated with summer rugby, player characteristics or changes in the game itself and future research needs to investigate these further.     

THE EFFECT OF HYPERTENSIVE EPISODES AND CARDIAC HYPERTROPHY ON THE CANINE CARDIAC BAROREFLEX

1. Left ventricular (LV) hypertrophy has been implicated in the reduction of baroreflex sensitivity present in hypertension. The aim of the current study was to investigate the mean arterial pressure-heart rate reflex (MAP-HR) in a model which induced left ventricular hypertrophy but no sustained blood pressure elevation. 2. Five mongrel dogs were exposed to transient blood pressure elevation of between 20 and 30 mmHg, through hindlimb compression using a pneumatic pressure suit, for 7 h per day, 6 days per week for 6 weeks. Resting blood pressure was not altered by the 6 week hindlimb compression intervention. 3. Echocardiographically determined LV mass (mean ± s.e.m.) was 116.0 ± 7.4 g prior to hindlimb compression (baseline) and elevated to 125.4 ± 8.1 g (P= 0.003) after 6 weeks of compression. A reduction in the early (E) to late (A) transmitral diastolic flow ratio (E/A) from 1.80 ± 0.06 at baseline to 1.54 ± 0.09 (P = 0.037) after the 6 week intervention suggested that cardiac compliance was reduced. 4. The maximum gain of the MAP-HR reflex, studied using the ‘steady-state’ drug technique, when blood pressure was normal, showed a trend for reduction from 3.85 ± 0.43 beats/min per mmHg at baseline to 3.10 ± 0.45 beats/min per mmHg (P= 0.067) after 6 weeks of compression. This gain reduction became significant after β-adrenoceptor blockade with propranolol (3.13 ± 0.55 vs 2.32 ± 0.25 beats/min per mmHg; P= 0.039). Covariant analysis showed a significant inverse correlation between LV mass and maximum gain (r= 0.96; P<0.001) during the 6 week compression period. 5. The MAP-HR reflex changes in this model mimic those present in hypertension and implicate cardiac hypertrophy as one possible mediator.