Acute Gastroenteritis: A Qualitative Study of Parental Motivations, Expectations, and Experiences During Out-of-Hours Primary Care.

PURPOSE: Acute gastroenteritis is a common infectious disease in children younger than 6 years of age. Although it is a self-limiting disease, it nevertheless has a high consultation rate in primary care, especially during out-of-hours primary care (OOH-PC). Reasons for this high consultation rate remain unclear. METHODS: The aim of this qualitative study was to explore parental motivations, expectations, and experiences of OOH-PC contacts for children with acute gastroenteritis. We conducted 14 semistructured interviews with parents who contacted OOH-PC in the Netherlands. Interviews were audio-recorded, transcribed, and analyzed using elements of grounded theory and a constant-comparison approach. RESULTS: Unusual behavior of the sick child, absent micturition, and ongoing vomiting and/or diarrhea, with decreased or no fluid intake, motivated parents to contact OOH-PC. Parents initiated contact to prevent symptom deterioration and to be reassured by a general practitioner (GP), expecting them to perform a thorough physical examination, provide information, and make follow-up plans. Parents reported dissatisfaction if they felt unheard, misunderstood, or not taken seriously, and this increased their likelihood of seeking another consultation. General practitioners did not always meet parental expectations. CONCLUSION: Multiple factors affect the decision for parents to contact OOH-PC for their child with gastroenteritis. There is a mismatch between parental expectations and actions of the GP. Awareness regarding parental feelings and understanding their expectations can guide GPs in the interaction with parents, which could improve satisfaction with primary health care and OOH-PC specifically.

Course of uncomplicated acute gastroenteritis in children presenting to out-of-hours primary care.

BACKGROUND: The aim of this article is to describe the courses of vomiting, diarrhea, fever, and clinical deterioration, in children with uncomplicated gastroenteritis at presentation. This study was performed as a 7-day prospective follow-up study in an out-of-hours primary care service. The course of vomiting, diarrhea, and fever was analyzed by generalized linear mixed modeling. Because young children (≤ 12 months) and children with severe vomiting are at increased risk of dehydration, the potentially more complicated courses of these groups are described separately. The day(s) most frequently associated with deterioration and the symptoms present in children who deteriorated during follow-up were also described. RESULTS: In total, 359 children presented with uncomplicated acute gastroenteritis to the out-of-hours primary care service. Of these, 31 (8.6%) developed a complicated illness and needed referral or hospitalization. All symptoms decreased within 5 days in most children (> 90%). Vomiting and fever decreased rapidly, but diarrhea decreased at a somewhat slower pace, especially among children aged 6-12 months. Children who deteriorated during follow-up had a higher frequency of vomiting at presentation and higher frequencies of vomiting and fever during follow-up. CONCLUSIONS: The frequency of vomiting, not its duration, appears to be the more important predictor of deterioration. When advising parents, it is important to explain the typical symptom duration and to focus on alarm symptoms. Clinicians should be vigilant for children with higher vomiting frequencies at presentation and during follow-up because these children are more likely to deteriorate.

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.

Cost-effectiveness of oral ondansetron for children with acute gastroenteritis in primary care: a randomised controlled trial.

BACKGROUND: Acute gastroenteritis is a common childhood condition with substantial medical and indirect costs, mostly because of referral, hospitalisation, and parental absence from work. AIM: To determine the cost-effectiveness of adding oral ondansetron to care as usual (CAU) for children with acute gastroenteritis presenting to out-of-hours primary care (OOH-PC). DESIGN AND SETTING: A pragmatic randomised controlled trial from December 2015 to January 2018, at three OOHPC centres in the north of the Netherlands (Groningen, Zwolle, and Assen) with a follow-up of 7 days. METHOD: Children were recruited at the OOH-PC and parents kept a parental diary. Inclusion criteria were: aged 6 months-6 years; diagnosis of acute gastroenteritis; at least four reported episodes of vomiting 24 hours before presentation, at least one of which was in the 4 hours before presentation; and written informed consent from both parents. Children were randomly allocated at a 1:1 ratio to either CAU (oral rehydration therapy) or CAU plus one dose of 0.1 mg/kg oral ondansetron. RESULTS: In total, 194 children were included for randomisation. One dose of oral ondansetron decreased the proportion of children who continued vomiting within the first 4 hours from 42.9% to 19.5%, (a decrease of 54.5%), with an odds ratio of 0.4 (95% confidence interval [CI] = 0.2 to 0.7; number needed to treat: four). Total mean costs in the ondansetron group were 31.2% lower (€488 [£420] versus €709 [£610]), and the total incremental mean costs for an additional child free of vomiting in the first 4 hours was -€9 (£8) (95% CI = -€41 [£35] to €3 [£3]). CONCLUSION: A single oral dose of ondansetron for children with acute gastroenteritis, given in OOH-PC settings, is both clinically beneficial and cost-effective.

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.

Gender and sex independently associate with common somatic symptoms and lifetime prevalence of chronic disease.

Sex and gender influence health differently. Associations between sex and health have been extensively studied, but gender (i.e. psychosocial sex) has been largely neglected, partly due to the absence of gender measures in cohort studies. Therefore, our objective was to test the unique associations of gender and sex with common somatic symptoms and chronic diseases, using a gender index created from existing cohort data. We applied LASSO logistic regression to identify, out of 153 unique variables, psychosocial variables that were predictive of sex (i.e. gender-related) in the Dutch LifeLines Cohort Study. These psychosocial variables covered gender roles and institutionalized gender. Using the estimated coefficients, gender indexes were calculated for each adult participant in the study (n = 152,728; 58.5% female; mean age 44.6 (13.1) years). We applied multiple ordinal and logistic regression to test the unique associations of the gender index and sex, and their interactions, with common somatic symptoms assessed by the SCL-90 SOM and self-reported lifetime prevalence of chronic diseases, respectively. We found that in 10.1% of the participants the gender index was not in line with participants' sex: 12.5% of men and 8.4% of women showed a discrepancy between gender index and sex. Feminine gender characteristics are associated with increased common somatic symptoms and chronic diseases, especially in men. Female sex is associated with a higher common somatic symptom burden, but not with a higher prevalence of chronic diseases. The study shows that gender and sex uniquely impact health, and should be considered in epidemiological studies. Our methodology shows that consideration of gender measures in studies is necessary and feasible, based on data generally present in cohort studies.

Psychological Interventions for Children with Functional Somatic Symptoms: A Systematic Review and Meta-Analysis.

OBJECTIVE: To analyze the effectiveness of psychological treatments on symptom load and associated disability in children with functional somatic symptoms, and to explore potential moderators of effects. STUDY DESIGN: Cochrane, PubMed, PsycINFO, EMBASE, and CINAHL were searched for randomized controlled trials published in peer-reviewed journals. Randomized controlled trials studying the effect of a psychological treatment on symptom load and disability in children with functional somatic symptoms were selected. Data on symptom load, disability, and school absence directly post-treatment and at follow-up were extracted by 2 assessors. Studies were appraised with the Cochrane risk of bias tool. Standardized mean differences were pooled in a random-effects model. Heterogeneity in effect-sizes was explored by use of meta-regressions. PROSPERO Registration ID: CRD42015029667. RESULTS: Out of 4098 identified records, 27 studies were included in this review of which 21 were included in meta-analyses. Psychological treatments reduced symptom load (Hedges g = -0.61), disability (Hedges g = -0.42), and school absence (Hedges g = -0.51) post-treatment in children suffering from various functional somatic symptoms. Effects were maintained at follow-up. Type and duration of symptoms, age, and treatment dose did not explain heterogeneity in effect-sizes between studies. Effect-sizes should be interpreted with caution because of the variety in outcome measures, unexplained heterogeneity in found effects and potential publication bias. CONCLUSIONS: Psychological interventions reduce symptom load, disability, and school absence in children with functional somatic symptoms. Future research should clarify which patient and treatment characteristics modify outcomes.

A concept mapping study on perpetuating factors of functional somatic symptoms from clinicians' perspective.

OBJECTIVE: The aim of this concept mapping study was to identify the structure and alleged importance of perpetuating factors of functional somatic symptoms (FSS) from the perspective of professionals. Further, we examined to which extent these factors have been addressed in scientific literature. METHODS: Ninety-nine perpetuating factors were sorted with respect to content using a card-sorting task by 61 experienced clinicians (62.3% psychologists, 75.4% female, mean age: 45.7 [SD: 10.6] years, mean duration of experience in treating FSS patients: 10.5 [SD: 7.6] years). These factors had been derived from in-depth interviews with 12 clinicians, with extensive experience in treating FSS. Thirty-eight clinicians rated the importance of the 99 factors on a scale ranging from 1 ('not important at all') to 10 ('extremely important'). RESULTS: Hierarchical cluster analysis revealed three overarching domains of perpetuating factors: 'Hypochondria', 'Social and relational problems' and 'Symptom-related emotions and habits'. These domains comprised 16 clusters, which were rated on importance between 6.1, 'Adverse physical factors and counterproductive lifestyle', and 7.8, 'Frustration and despair regarding the symptoms'. All clusters have been addressed in scientific literature. CONCLUSIONS: This study revealed an encompassing hierarchical structure of somatic, emotional, cognitive, behavioral, and social factors of importance in the perpetuation of FSS based on expert opinions. This structure will guide the development of personalized treatment of FSS.

Life events and functional somatic symptoms: A population study in older adolescents.

The purpose of this study was to investigate the effect of negative life events on functional somatic symptoms (FSSs) in adolescents, based on data from 957 participants of the population cohort TRacking Adolescents' Individual Lives Survey. Life events experienced between age 16 and age 19 were assessed with the Kendler's Life Stress interview. FSSs at age 19 and age 16 were measured with the Youth and Adult Self-Report. The hypotheses were tested by the use of a latent change model. Life events predicted FSSs, even when adjusted for pre-event levels of FSSs, symptoms of anxiety and depression, and socio-economic status (B = 0.006, 95% CI [0.003, 0.008], ß = .32). Whereas illness-related life events did not predict FSSs independently (B = -0.003, 95% CI [-0.005, 0.09], ß = .05), non-illness-related life events did (B = 0.007, 95% CI [0.004, 0.010], ß = .31). A past-year diagnosis of anxiety and/or depression had a significant influence on the association between life events and FSSs (B = 0.37, 95% CI [0.30, 0.46], ß = .71), while female sex, exposure to childhood adversities, and family malfunctioning had not. In conclusion, our findings show that FSSs are associated with negative life events in older adolescents. We did not find evidence for stronger effects of illness-related events.

Self-Help for Medically Unexplained Symptoms: A Systematic Review and Meta-Analysis.

OBJECTIVE: Medically unexplained symptoms (MUS), which are highly prevalent in all fields of medicine, are considered difficult to treat. The primary objective of this systematic review and meta-analysis was to assess the efficacy of self-help for adults with MUS. METHODS: Four electronic databases were searched for relevant studies. Randomized controlled trials comparing self-help to usual care or waiting list in adults with MUS were selected. Studies were critically appraised using the Cochrane "risk of bias assessment tool." Standardized mean differences (Hedges g) were pooled using a random-effects model. Outcomes were symptom severity and quality of life (QoL) directly posttreatment and at follow-up. RESULTS: Of 582 studies identified, 18 studies met all inclusion criteria. Studies were heterogeneous with regard to patient populations, intervention characteristics, and outcome measures. Compared with usual care or waiting list, self-help was associated with lower symptom severity (17 studies, n = 1894, g = 0.58, 95% confidence interval = 0.32-0.84, p < .001) and higher QoL (16 studies, n = 1504, g = 0.66, 95% confidence interval = 0.34-0.99, p < .001) directly posttreatment. Similar effect sizes were found at follow-up. A high risk of bias was established in most of the included studies. However, sensitivity analyses suggested that this did not significantly influence study results. Funnel plot asymmetry indicated potential publication bias. CONCLUSIONS: Self-help is associated with a significant reduction in symptom severity and improvement of QoL. The methodological quality of included studies was suboptimal, and further research is needed to confirm the findings of this meta-analysis.

Sleep problems and pain: a longitudinal cohort study in emerging adults.

Sleep and pain are thought to be bidirectional related on a daily basis in adolescents with chronic pain complaints. In addition, sleep problems have been shown to predict the long-term onset of musculoskeletal pain in middle-aged adults. Yet, the long-term effects of sleep problems on pain duration and different types of pain severity in emerging adults (age: 18-25) are unknown. This study investigated the cross-sectional and longitudinal relationship between sleep problems and chronic pain, and musculoskeletal pain, headache, and abdominal pain severity in a general population of emerging adults. We studied whether these relationships were moderated by sex and whether symptoms of anxiety and depression, fatigue, or physical inactivity mediated these effects. Data of participants from the longitudinal Dutch TRacking Adolescents' Individual Lives Survey were used. Follow-up data were collected in 1753 participants who participated in the fourth (N = 1668, mean age: 19.0 years [SD = 0.6]) and/or fifth (N = 1501, mean age: 22.3 years [SD = 0.6]) assessment wave. Autoregressive cross-lagged models were used for analyses. Sleep problems were associated with chronic pain, musculoskeletal pain, headache and abdominal pain severity, and predicted chronic pain and an increase in musculoskeletal pain severity at 3 years of follow-up. This prospective effect was stronger in females than in males and was mediated by fatigue but not by symptoms of anxiety and depression or physical inactivity. Only abdominal pain had a small long-term effect on sleep problems. Our results suggest that sleep problems may be an additional target for treatment in female emerging adults with musculoskeletal pain complaints.

Short report: Functional somatic symptoms are associated with perfectionism in adolescents.

OBJECTIVE: The aim of this study is to investigate the influence of perfectionism on functional somatic symptoms (FSSs) in adolescents. It was hypothesized that perfectionism predicts higher levels of FSSs cross-sectionally and longitudinally, and that anxiety and depression mediate this relationship. DESIGN: This prospective population-based study was part of the Dutch Tracking Adolescents' Individual Lives Survey (N=2230; 50.8% girls). Data from 1878 participants attending the third (T3) or fourth (T4) assessment wave were used (mean age T3: 16.2 (SD:0.7); mean age T4: 19.0 (SD:0.6)). Multiple regression and mediation analyses were performed in Mplus. MAIN OUTCOME MEASURES: FSSs, perfectionism (i.e. the feeling one has to be perfect), anxiety and depression were assessed with the Youth Self-Report at the third and fourth wave. RESULTS: Perfectionism was associated with a higher level of FSSs in adolescents, both cross-sectionally (B=0.11, 95%-CI: 0.08-0.14) and longitudinally (B=0.05, 95%-CI: 0.02-0.08). There was a small indirect effect of perfectionism on FSSs trough anxiety and depression (B=0.02, 95%-CI: 0.003-0.03, k(2)=0.02). CONCLUSION: The results suggest that perfectionism predicts the course of FSSs with a small indirect effect of perfectionism on FSSs trough anxiety and depression. Further research is needed to clarify which aspects of perfectionism are particularly responsible for this effect.

Sexual abuse predicts functional somatic symptoms: an adolescent population study.

The main aim of this study was to investigate the effect of childhood sexual abuse on medically not well explained or functional somatic symptoms (FSSs) in adolescents. We hypothesized that sexual abuse predicts higher levels of FSSs and that anxiety and depression contribute to this relationship. In addition, we hypothesized that more severe abuse is associated with higher levels of FSSs and that sexual abuse is related to gastrointestinal FSSs in particular. This study was part of the Tracking Adolescents' Individual Lives Survey (TRAILS): a general population cohort which started in 2001 (N=2,230; 50.8% girls, mean age 11.1 years). The current study uses data of 1,680 participants over four assessment waves (75% of baseline, mean duration of follow-up: 8 years). FSSs were measured by the Somatic Complaints subscale of the Youth Self-Report at all waves. Sexual abuse before the age of sixteen was assessed retrospectively with a questionnaire at T4. To test the hypotheses linear mixed models were used adjusted for age, sex, socioeconomic status, anxiety and depression. Sexual abuse predicted higher levels of FSSs after adjustment for age sex and socioeconomic status (B=.06) and after additional adjustment for anxiety and depression (B=.03). While sexual abuse involving physical contact significantly predicted the level of FSSs (assault; B=.08, rape; B=.05), non-contact sexual abuse was not significantly associated with FSSs (B=.04). Sexual abuse was not a stronger predictor of gastrointestinal FSSs (B=.06) than of all FSSs. Further research is needed to clarify possible mechanisms underlying relationship between sexual abuse and FSSs.

An inactive lifestyle and low physical fitness are associated with functional somatic symptoms in adolescents. The TRAILS study.

OBJECTIVE: An inactive lifestyle has been associated with functional somatic symptoms (FSS), but findings are contradictory. Moreover, mediating factors in this relationship are unclear. We examined whether low physical activity was related to FSS in adolescents, and whether this association was mediated by low physical fitness. METHODS: This study was part of the Dutch longitudinal cohort study TRAILS, in which 1816 adolescents (mean age 16.3 years, SD 0.7) participated during the third (T3) and 1881 (mean age 19.1 years, SD 0.6) during the fourth (T4) assessment waves. Adolescents' exercise and sedentary behavior levels and the number of FSS were assessed by questionnaires at T3 and T4. Physical fitness (VO2Max) was determined for 687 adolescents by a shuttle run test at T3. The association between physical activity and FSS was examined with bootstrapped linear regression analyses, adjusted for smoking and gender. In addition, bootstrapped mediation analyses were performed. RESULTS: A lack of exercise (b=0.05, bootstrap 95%--CI: 0.01 to 0.09) and high sedentary behavior (b=0.10, bootstrap 95%--CI: 0.06 to 0.14) at T3 were positively associated with FSS at T3. Since no longitudinal effects were found, shared associations were tested instead of mediation. The associations between a lack of exercise and FSS, and sedentary behavior and FSS were shared with physical fitness (b=0.01, bootstrap 95%--CI: 0.010.02. and b=0.03, bootstrap 95%--CI: 0.010.05). CONCLUSION: An inactive lifestyle is associated with increased FSS in adolescents. Only part of this association is shared with low physical fitness.