Oral ondansetron for paediatric gastroenteritis in primary care: a randomised controlled trial.

BACKGROUND: Acute gastroenteritis (AGE) affects almost all children aged ≤5 years. In secondary care, ondansetron was found to be effective at reducing vomiting. AIM: To determine the effectiveness of adding oral ondansetron to care as usual (CAU) to treat vomiting in children with AGE attending out-ofhours primary care (OOH-PC). DESIGN AND SETTING: A pragmatic randomised controlled trial at three OOH-PC centres in the north of the Netherlands (Groningen, Zwolle, and Assen), with a follow-up of 7 days. METHOD: Children were included if they were: aged 6 months-6 years; AGE diagnosed by a GP; ≥4 reported episodes of vomiting in the 24 hours before presentation; ≥1 reported episode of vomiting in the 4 hours before presentation; and written informed consent from both parents. Children were randomly allocated to either the control group or the intervention group. The control group received CAU, namely oral rehydration therapy. The intervention group received CAU plus one dose of oral ondansetron (0.1 mg/kg). RESULTS: In total, 194 children were included for randomisation. One dose of oral ondansetron decreased the proportion of children who continued vomiting within 4 hours from 42.9% to 19.5%, with an odds ratio of 0.37 (95% confidence interval [CI] = 0.20 to 0.72, number needed to treat: four). Ondansetron also decreased the number of vomiting episodes within 4 hours (incidence rate ratio 0.51 [95% CI = 0.29 to 0.88]) and improved overall parental satisfaction with treatment (P = 0.027). CONCLUSION: Children with AGE and increased risk of dehydration due to vomiting could be treated with ondansetron in primary care to stop vomiting more quickly and increase parental satisfaction with treatment. These results could be used to improve the quality and efficacy of general practice medicine.

Recommendations for clinical research in children presenting to primary care out-of-hours services: a randomised controlled trial with parallel cohort study.

BACKGROUND: Research in primary care is essential, but recruiting children in this setting can be complex and may cause selection bias. Challenges surrounding informed consent, particularly in an acute clinical setting, can undermine feasibility. The off-protocol use of an intervention nearing implementation has become common in pragmatic randomised controlled trials (RCTs) set in primary care. AIM: To describe how the informed consent procedure affects study inclusion and to assess how off-protocol medication prescribing affects participant selection in a paediatric RCT. DESIGN & SETTING: A pragmatic RCT evaluating the cost-effectiveness of oral ondansetron in children diagnosed with acute gastroenteritis (AGE) in primary care out-of-hours services and a parallel cohort study. METHOD: Consecutive children aged 6 months to 6 years attending primary care out-of-hours services with AGE were evaluated to assess the feasibility of obtaining informed consent, the off-protocol use of ondansetron, and other inclusion and exclusion criteria. RESULTS: The RCT's feasibility was reduced by the informed consent procedure because 39.0% (n = 325/834) of children were accompanied by only one parent. GPs prescribed ondansetron off-protocol to 34 children (4.1%) of which 19 children were eligible for the RCT. RCT-eligible children included in the parallel cohort study had fewer risk factors for dehydration than children in the RCT despite similar dehydration assessments by GPs. CONCLUSION: The informed consent procedure and off-protocol use of study medication affect the inclusion rate, but had little effect on selection. A parallel cohort study alongside the RCT can help evaluate selection bias, and a pilot study can reveal potential barriers to inclusion.

Referral rates for children with acute gastroenteritis: a retrospective cohort study.

BACKGROUND: Hospital admission rates are increasing for children with acute gastroenteritis. However, it is unknown whether this increase is accompanied by an increase in referral rates from GPs due to increased workloads in primary care out-of-hours (OOH) services. AIM: To assess trends in referral rates from primary care OOH services to specialist emergency care for children presenting with acute gastroenteritis. DESIGN & SETTING: This retrospective cohort study covered a period from September 2007-September 2014. Children aged 6 months to 6 years presenting with acute gastroenteritis to a primary care OOH service were included. METHOD: Pseudonymised data were obtained, and children were analysed overall and by age category. Χ2 trend tests were used to assess rates of acute gastroenteritis, referrals, face-to-face contacts, and oral rehydration therapy (ORT) prescriptions. RESULTS: The data included 12 455 children (6517 boys), with a median age of 20.2 months (interquartile range [IQR] 11.6 to 36.0 months). Over 7 years, incidence rates of acute gastroenteritis decreased significantly, and face-to-face contact rates increased significantly (both, P<0.01). However, there was no significant trend for referral rates (P = 0.87) or prescription rates for ORT (P = 0.82). Subgroup analyses produced comparable results, although there was an increase in face-to-face contact rates for the older children. CONCLUSION: Incidence rates for childhood acute gastroenteritis presenting in OOH services decreased and referral rates did not increase significantly. These findings may be useful as a reference for the impact of new interventions for childhood acute gastroenteritis.

Interactions between physicians and the pharmaceutical industry generally and sales representatives specifically and their association with physicians' attitudes and prescribing habits: a systematic review.

OBJECTIVES: The objective of this review is to explore interactions between physicians and the pharmaceutical industry including sales representatives and their impact on physicians' attitude and prescribing habits. DATA SOURCES: PubMed, Embase, Cochrane Library and Google scholar electronic databases were searched from 1992 to August 2016 using free-text words and medical subject headings relevant to the topic. STUDY SELECTION: Studies included cross-sectional studies, cohort studies, randomised trials and survey designs. Studies with narrative reviews, case reports, opinion polls and letters to the editor were excluded from data synthesis. DATA EXTRACTION: Two reviewers independently extracted the data. Data on study design, study year, country, participant characteristics, setting and number of participants were collected. DATA SYNTHESIS: Pharmaceutical industry and pharmaceutical sales representative (PSR) interactions influence physicians' attitudes and their prescribing behaviour and increase the number of formulary addition requests for the company's drug. CONCLUSION: Physician-pharmaceutical industry and its sales representative's interactions and acceptance of gifts from the company's PSRs have been found to affect physicians' prescribing behaviour and are likely to contribute to irrational prescribing of the company's drug. Therefore, intervention in the form of policy implementation and education about the implications of these interactions is needed.

Sexual health of Dutch medical students: nothing to worry about.

INTRODUCTION: Little is known about the sexual lives and development of medical students because of relatively small sample sizes and, in particular, low response rates in research. Enhancing medical students' awareness and understanding of sexual behavior is imperative, as gaps in knowledge might impede effective sexual health consultations in their later professional practice. AIM: The aim of this study was to provide insight into the sexual lives and development of medical students. MAIN OUTCOME MEASURES: The main outcome measures of this study are demographic, contextual, and sexual data based on validated surveys. METHODS: Preclinical medical students aged under 26 years were approached during scheduled classes and by e-mail to complete a web-based questionnaire. Our results were compared with international and Dutch normative data. Ordinal regression analysis and Pearson's correlation analysis were used to assess relationships between variables. RESULTS: A total of 1,598 questionnaires were returned (response rate 52%: 1,198 by women, 400 by men). There were 719 first-year students (mean age 19.17 years) and 879 third-year students (mean age 21.5 years). Gender distribution differences were seen in all the cohorts and were corrected for. Compared with international and Dutch (88%) normative data, our first- (62.7%; P<0.001) and third-year (79.9%; P=0.018) medical students had less sexual experience and showed different advancements in sexual behavior. However, these differences decreased, which suggests that medical students "catch-up" as their age increases. Sexual behavior in our sample did not differ from international data, except for a strikingly high sexual satisfaction (80%). We also confirmed that social and environmental characteristics change with alterations in sexual behavior. Although contraceptive measures were used more frequently (98%; P=0.006), sexually transmitted diseases were more common (4.6%; P=0.008), which suggests inappropriate use of protective measures. Independent predictive determinants for protective sexual behavior were the form of relationship (P<0.001; OR=1.97) and sexual orientation (P=0.009; odds ratio=2.26). CONCLUSION: These data provide insight into the sexuality of medical students. The results of this study reliably clarify previous findings and form a solid basis for further research.