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

Background: Acute gastroenteritis affects almost all children younger than 5 years. Due to vomiting the standard oral rehydration therapy (ORT) treatment is less effective. In secondary care, ondansetron was found to be effective in reducing vomiting. Aim: To determine the effectiveness of adding oral ondansetron to care-as-usual on vomiting in children with acute gastroenteritis attending out-of-hours primary care. Design and setting: A pragmatic randomised controlled trial with a follow-up of 7 days, at three out-of-hours primary care centres. Method: Inclusion criteria: 1) age 6 months to 6 years, 2) acute gastroenteritis diagnosed by a general practitioner, 3) at least four reported episodes of vomiting in the 24 hours before presentation, 4) at least one reported episode of vomiting in the 4 hours before presentation, and 5) written informed consent from both parents. The control group received care-as-usual (ORT). The intervention group received care-as-usual 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% CI = 0.20–0.72, NNT 4). Ondansetron also decreased the number of vomiting episodes within 4 hours, incidence rate ratio of 0.51 (95% CI, 0.29-0.88), and improved overall parental satisfaction with treatment (p = 0.027). Conclusions: Ondansetron decreased vomiting and increased parental satisfaction in children with acute gastroenteritis. We were not able to show an increased ORT intake or decrease in referral rate.

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

British Journal of General Practice ◽

10.3399/bjgp.2020.1093 ◽

2021 ◽

pp. BJGP.2020.1093

Author(s):

Anouk AH Weghorst ◽

Gea A Holtman ◽

Irma J Bonvanie ◽

Pien I Wolters ◽

Boudewijn J Kollen ◽

...

Keyword(s):

Primary Care ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Acute Gastroenteritis ◽

Controlled Trial ◽

Oral Rehydration Therapy ◽

Out Of Hours ◽

Oral Rehydration ◽

Randomised Controlled ◽

Oral Ondansetron

Background: Acute gastroenteritis is a common childhood disease with substantial medical and indirect costs, mostly because of referral, hospitalization and parental absence from work. Aim: To determine the cost-effectiveness of adding oral ondansetron to care-as-usual for children with acute gastroenteritis in out-of-hours primary care. Design and setting: A pragmatic randomised controlled trial at three out-of-hours primary care centres, with a follow-up of 7 days. Method: Inclusion criteria were: 1) age 6 months to 6 years; 2) diagnosis of acute gastroenteritis; 3) at least four reported episodes of vomiting 24 hours before presentation, whereof; 4) at least one in the 4 hours before presentation; and 5) written informed consent from both parents. Children were randomly allocated in a 1:1 ratio to either care-as-usual (oral rehydration therapy) or care-as-usual 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%, with an odds ratio of 0.4 (95% CI = 0.2–0.7, NNT 4). Total mean costs in the ondansetron group were 31.2% lower (€488 vs €709), and the total incremental mean costs for an additional child free of vomiting in the first 4 hours was −€9 (95% confidence interval, −€41 to €3). Conclusion: A single oral dose of ondansetron for children with acute gastroenteritis, given in out-of-hours primary care settings, is both clinically beneficial and cost-effective.

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Triaging and Referring In Adjacent General and Emergency Departments (the TRIAGE trial): a cluster randomised controlled trial

10.1101/2021.08.16.21261782 ◽

2021 ◽

Author(s):

Stefan Morreel ◽

Hilde Philips ◽

Diana De Graeve ◽

Koenraad G Monsieurs ◽

Jarl Kampen ◽

...

Keyword(s):

Primary Care ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

Predictive Values ◽

Randomised Controlled

Objectives: To determine the effectiveness and safety of a tool diverting low urgency patients eligible for primary care from an emergency department (ED) to the adjacent general practitioner cooperative (GPC). Methods: Unblinded, randomised controlled trial with weekends serving as clusters (three intervention clusters for each control). The intervention was nurse-led triage using a new tool assigning patients to either ED or GPC. During intervention weekends, patients were encouraged to follow this assignment while it was not communicated to the patients during control weekends (they remained at the ED). The primary outcome was the proportion of patients assigned to and handled by the GPC during intervention weekends. The trial was randomised for the secondary outcome: the proportion of patients assigned to the GPC during intervention and control weekends. Additional outcomes were association of these outcomes with possible confounders (study tool parameters, nurse, and patient characteristics), proportion of patients referred back to the ED by the GPC, hospitalisations, and performance of the study tool to detect primary care eligible patients (with the opinion of the treating physician as the gold standard). Results: In the intervention group, 838/6374 patients (13.3%, 95% CI 12.5 to 14.2) were assigned to the GPC (secondary outcome), in the control group 431/1744 (24.7%, 95% CI 22.7 to 26.8). In the intervention group, 599/6374 patients (9.5%, 95% CI 8.8 to 10.3) experienced the primary outcome which was influenced by the chosen MTS presentational flowchart, patient's age, and the nurse. 24/599 patients (4.0%, 95% CI 2.7 to 5.9) patients were referred back to the ED of which three were hospitalised. Positive and negative predictive values of the studied tool during intervention weekends were 0.96 (95%CI 0.94 to 0.97) and 0.60 (95% CI 0.58 to 0.62). Out of the patients assigned to the GPC, 2.4% (95% CI 1.7 to 3.4) were hospitalised. Conclusions: ED nurses using a new tool safely diverted 9.5% of the included patients to primary care. ClinicalTrials.gov Identifier: NCT03793972 Funding: Research Foundation, Flanders (FWO)

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Triaging and referring in adjacent general and emergency departments (the TRIAGE trial): A cluster randomised controlled trial

PLoS ONE ◽

10.1371/journal.pone.0258561 ◽

2021 ◽

Vol 16 (11) ◽

pp. e0258561

Author(s):

Stefan Morreel ◽

Hilde Philips ◽

Diana De Graeve ◽

Koenraad G. Monsieurs ◽

Jarl K. Kampen ◽

...

Keyword(s):

Primary Care ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Triage System ◽

Predictive Values ◽

Randomised Controlled

Objectives To determine whether a new triage system safely diverts a proportion of emergency department (ED) patients to a general practitioner cooperative (GPC). Methods Unblinded randomised controlled trial with weekends serving as clusters (three intervention clusters for each control). The intervention was triage by a nurse using a new extension to the Manchester Triage System assigning low-risk patients to the GPC. During intervention weekends, patients were encouraged to follow this assignment; it was not communicated during control weekends (all patients remained at the ED). The primary outcome was the proportion of patients assigned to and handled by the GPC during intervention weekends. The trial was randomised for the secondary outcome: the proportion of patients assigned to the GPC. Additional outcomes were association of these outcomes with possible confounders (study tool parameters, nurse, and patient characteristics), proportion of patients referred back to the ED by the GPC, hospitalisations, and performance of the study tool to detect primary care patients (the opinion of the treating physician was the gold standard). Results In the intervention group, 838/6294 patients (13.3%, 95% CI 12.5 to 14.2) were assigned to the GPC, in the control group this was 431/1744 (24.7%, 95% CI 22.7 to 26.8). In total, 599/6294 patients (9.5%, 95% CI 8.8 to 10.3) experienced the primary outcome which was influenced by the reason for encounter, age, and the nurse. 24/599 patients (4.0%, 95% CI 2.7 to 5.9) were referred back to the ED, three were hospitalised. Positive and negative predictive values of the studied tool during intervention weekends were 0.96 (95%CI 0.94 to 0.97) and 0.60 (95% CI 0.58 to 0.62). Out of the patients assigned to the GPC, 2.4% (95% CI 1.7 to 3.4) were hospitalised. Conclusions ED nurses using a new tool safely diverted 9.5% of the included patients to primary care. Trial registration ClinicalTrials.gov Identifier: NCT03793972

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Withdrawal of unnecessary antidepressant medication: a randomised controlled trial in primary care

BJGP Open ◽

10.3399/bjgpopen17x101265 ◽

2017 ◽

Vol 1 (4) ◽

pp. bjgpopen17X101265 ◽

Cited By ~ 12

Author(s):

Rhona Eveleigh ◽

Esther Muskens ◽

Peter Lucassen ◽

Peter Verhaak ◽

Jan Spijker ◽

...

Keyword(s):

Primary Care ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Antidepressant Medication ◽

Treatment Recommendation ◽

Control Group ◽

Antidepressant Use ◽

Randomised Controlled

BackgroundAntidepressant use has increased exponentially in recent decades, mostly due to long continuation.AimTo assess the effectiveness of a tailored recommendation to withdraw antidepressant treatment.Design & settingRandomised controlled trial in primary care (PANDA study) in the Netherlands.MethodLong-term antidepressant users (≥9 months) were selected from GPs prescription databases. Patients were diagnosed with the Composite International Diagnostic Interview (CIDI). Long-term users without indication for maintenance treatment (overtreatment) were selected. The intervention consisted of disclosure of the current psychiatric diagnosis combined with a tailored treatment recommendation. Patients were followed for 12 months.ResultsThe study included 146 participants from 45 family practices. Of the 70 patients in the intervention group, 34 (49%) did not comply with the advice to stop their antidepressant medication. Of the 36 (51%) patients who agreed to try, only 4 (6%) succeeded. These figures were consistent with the control group, where 6 (8%) of the 76 patients discontinued antidepressant use successfully. Patients who were recommended to discontinue their antidepressant medication reported a higher relapse rate than the control group (26% versus 13%, P = 0.05).ConclusionChanging inappropriate long-term antidepressant use is difficult.

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Multicentre, randomised controlled trial of PDSAFE, a physiotherapist-delivered fall prevention programme for people with Parkinson’s

Journal of Neurology Neurosurgery & Psychiatry ◽

10.1136/jnnp-2018-319448 ◽

2019 ◽

Vol 90 (7) ◽

pp. 774-782 ◽

Cited By ~ 15

Author(s):

Kim Chivers Seymour ◽

Ruth Pickering ◽

Lynn Rochester ◽

Helen C Roberts ◽

Claire Ballinger ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Fall Prevention ◽

Controlled Trial ◽

Intervention Group ◽

Prevention Programme ◽

Control Group ◽

Chair Stand ◽

Subgroup Analyses ◽

Randomised Controlled ◽

Fall Prevention Programme

ObjectiveTo estimate the effect of a physiotherapist-delivered fall prevention programme for people with Parkinson’s (PwP).MethodsPeople at risk of falls with confirmed Parkinson’s were recruited to this multicentre, pragmatic, investigator blind, individually randomised controlled trial with prespecified subgroup analyses. 474 PwP (Hoehn and Yahr 1–4) were randomised: 238 allocated to a physiotherapy programme and 236 to control. All participants had routine care; the control group received a DVD about Parkinson’s and single advice session at trial completion. The intervention group (PDSAFE) had an individually tailored, progressive home-based fall avoidance strategy training programme with balance and strengthening exercises. The primary outcome was risk of repeat falling, collected by self-report monthly diaries, 0–6 months after randomisation. Secondary outcomes included Mini-BESTest for balance, chair stand test, falls efficacy, freezing of gait, health-related quality of life (EuroQol EQ-5D), Geriatric Depression Scale, Physical Activity Scale for the Elderly and Parkinson’s Disease Questionnaire, fractures and rate of near falling.ResultsAverage age is 72 years and 266 (56%) were men. By 6 months, 116 (55%) of the control group and 125 (61.5%) of the intervention group reported repeat falls (controlled OR 1.21, 95% CI 0.74 to 1.98, p=0.447). Secondary subgroup analyses suggested a different response to the intervention between moderate and severe disease severity groups. Balance, falls efficacy and chair stand time improved with near falls reduced in the intervention arm.ConclusionPDSAFE did not reduce falling in this pragmatic trial of PwP. Other functional tasks improved and reduced fall rates were apparent among those with moderate disease.Trial registration numberISRCTN48152791.

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Effectiveness of a primary care-based group educational intervention in the management of patients with migraine: a randomized controlled trial

Primary Health Care Research & Development ◽

10.1017/s1463423619000720 ◽

2019 ◽

Vol 20 ◽

Cited By ~ 1

Author(s):

Iñaki Aguirrezabal ◽

Maria Soledad Pérez de San Román ◽

Raquel Cobos-Campos ◽

Estibalitz Orruño ◽

Arturo Goicoechea ◽

...

Keyword(s):

Primary Care ◽

Educational Intervention ◽

Controlled Trial ◽

Basque Country ◽

Intervention Group ◽

Cost Effective ◽

Response To Treatment ◽

Secondary Outcome ◽

Control Group ◽

Randomised Controlled

Abstract Aim: The aim of this study was to assess the effectiveness of a primary care-based group educational intervention about concepts of pain neuroscience for the management of migraine compared to the routine medical care delivered to patients with this condition. Background: The way pain is understood has been radically changed in recent decades, thanks to developments in the field of neuroscience. Thus, migraine may develop as a result of an exaggerated perception of threat that activates the pain neuromatrix, which might be modifiable, from a learning perspective, by adjusting the beliefs and behaviours that favour the onset of an attack. Methods: A randomised controlled trial was carried out in five primary care health centres of Vitoria-Gasteiz (Basque Country, Spain). The follow-up period was 12 months. The main outcome measure was the reduction in days lost due to migraine-related disability according to the Migraine Disability Assessment Test (MIDAS) score. Secondary outcome measures included the intensity and frequency of the pain and the number of analgesic drugs taken in the previous three months. A positive response to treatment was considered when the MIDAS score decreased by at least 50% from baseline. Findings: Days lost due to migraine-related disability decreased by at least 50% in 68.9% (n = 37) of patients in the intervention group and 34.6% of patients in the control group (n = 18) (P < 0.001). The intensity of the headache [odds ratio (OR) 9.116; P = 0.005] and the medication intake (OR 13.267; P < 0.001) were also significantly reduced with the intervention. Conclusions: The provision of suitable information through a group educational intervention delivered in primary care appears to be effective in preventing migraine attacks. Moreover, the intervention could offer a new cost-effective management alternative that seems to reduce the need for pharmacological treatment in patients with migraine.

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Efficacy of a smartphone-based coaching program for addiction prevention among apprentices: study protocol of a cluster-randomised controlled trial

BMC Public Health ◽

10.1186/s12889-020-09995-6 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Severin Haug ◽

Raquel Paz Castro ◽

Andreas Wenger ◽

Michael P. Schaub

Keyword(s):

Randomised Controlled Trial ◽

Cigarette Smoking ◽

Internet Use ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Control Group ◽

Addiction Prevention ◽

Cluster Randomised ◽

Randomised Controlled

Abstract Background A large proportion of apprentices shows addictive behaviours like cigarette smoking, alcohol, cannabis, or compulsive Internet use, others do not show such behaviours at all. ready4life is a smartphone application-based coaching program for apprentices, which takes into account the heterogeneity of adolescent addictive behaviour by promoting life skills and reducing risk behaviours. The main objective of the planned study is to test the efficacy of ready4life for addiction prevention among apprentices in Switzerland within a controlled trial. Methods/design The efficacy of the ready4life coaching program will be tested in comparison to an assessment only control group, within a cluster-randomised controlled trial with one follow-up assessment after 6 months. At the beginning of the program, participants of the intervention group will receive an individual profile, showing areas in which they have sufficient resources and in which there is a need for coaching. Based on this feedback, they can select two out of the following six program modules: stress, social skills, Internet use, tobacco/e-cigarettes, cannabis, and alcohol. Participants of the intervention group will receive individualised coaching by a conversational agent (chatbot) for a period of four months. The coaching relies on motivational and social-cognitive principles of behaviour change. Within weekly dialogues, the coach provides individually tailored information in different formats, such as videoclips, texts, or pictures. Study participants will be 1318 apprentices with a minimum age of 15, recruited in approximately 100 vocational school classes in Switzerland. Primary outcome will be a composite measure for addictive behaviours including (1) at risk-drinking, (2) tobacco/e-cigarette smoking, (3) cannabis use, and (4) problematic Internet use. Discussion The study will reveal whether this universally implementable but individually tailored intervention approach is effective in preventing the onset and escalation of addictive behaviors among apprentices. Trial registration ISRCTN59908406 (registration date: 21/10/2020).

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Assessment of the Effectiveness of a Computerised Decision-Support Tool for Health Professionals for the Prevention and Treatment of Childhood Obesity. Results from a Randomised Controlled Trial

Nutrients ◽

10.3390/nu11030706 ◽

2019 ◽

Vol 11 (3) ◽

pp. 706 ◽

Cited By ~ 4

Author(s):

George Moschonis ◽

Maria Michalopoulou ◽

Konstantina Tsoutsoulopoulou ◽

Elpis Vlachopapadopoulou ◽

Stefanos Michalacos ◽

...

Keyword(s):

Decision Support ◽

Childhood Obesity ◽

Randomised Controlled Trial ◽

Healthcare Professionals ◽

Controlled Trial ◽

Intervention Group ◽

Decision Support Tool ◽

Control Group ◽

Support Tool ◽

Randomised Controlled

We examined the effectiveness of a computerised decision-support tool (DST), designed for paediatric healthcare professionals, as a means to tackle childhood obesity. A randomised controlled trial was conducted with 65 families of 6–12-year old overweight or obese children. Paediatricians, paediatric endocrinologists and a dietitian in two children’s hospitals implemented the intervention. The intervention group (IG) received personalised meal plans and lifestyle optimisation recommendations via the DST, while families in the control group (CG) received general recommendations. After three months of intervention, the IG had a significant change in dietary fibre and sucrose intake by 4.1 and −4.6 g/day, respectively. In addition, the IG significantly reduced consumption of sweets (i.e., chocolates and cakes) and salty snacks (i.e., potato chips) by −0.1 and −0.3 portions/day, respectively. Furthermore, the CG had a significant increase of body weight and waist circumference by 1.4 kg and 2.1 cm, respectively, while Body Mass Index (BMI) decreased only in the IG by −0.4 kg/m2. However, the aforementioned findings did not differ significantly between study groups. In conclusion, these findings indicate the dynamics of the DST in supporting paediatric healthcare professionals to improve the effectiveness of care in modifying obesity-related behaviours. Further research is needed to confirm these findings.

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Postcards from the EDge: 5-year outcomes of a randomised controlled trial for hospital-treated self-poisoning

The British Journal of Psychiatry ◽

10.1192/bjp.bp.112.112664 ◽

2013 ◽

Vol 202 (5) ◽

pp. 372-380 ◽

Cited By ~ 50

Author(s):

Gregory L. Carter ◽

Kerrie Clover ◽

Ian M. Whyte ◽

Andrew H. Dawson ◽

Catherine D'Este

Keyword(s):

Randomised Controlled Trial ◽

Psychiatric Hospital ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Treatment As Usual ◽

Psychiatric Admissions ◽

Bed Days ◽

Randomised Controlled ◽

Event Rates

BackgroundRepetition of hospital-treated self-poisoning and admission to psychiatric hospital are both common in individuals who self-poison.AimsTo evaluate efficacy of postcard intervention after 5 years.MethodA randomised controlled trial of individuals who have self-poisoned: postcard intervention (eight in 12 months) plus treatment as usualv.treatment as usual. Our primary outcomes were self-poisoning admissions and psychiatric admissions (proportions and event rates).ResultsThere was no difference between groups for any repeat-episode self-poisoning admission (intervention group: 24.9%, 95% CI 20.6-29.5; control group: 27.2%, 95% CI 22.8-31.8) but there was a significant reduction in event rates (incidence risk ratio (IRR)=0.54, 95% CI 0.37-0.81), saving 306 bed days. There was no difference for any psychiatric admission (intervention group: 38.1%, 95% CI 33.1-43.2; control group: 35.5%, 95% CI 30.8-40.5) but there was a significant reduction in event rates (IRR=0.66, 95% CI 0.47-0.91), saving 2565 bed days.ConclusionsA postcard intervention halved self-poisoning events and reduced psychiatric admissions by a third after 5 years. Substantial savings occurred in general hospital and psychiatric hospital bed days.

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Effects of a kindergarten intervention on vegetables served and staff’s food-related practices: results of a cluster randomised controlled trial – the BRA study

Public Health Nutrition ◽

10.1017/s1368980019003963 ◽

2020 ◽

Vol 23 (6) ◽

pp. 1117-1126

Author(s):

Anne Himberg-Sundet ◽

Anne Lene Kristiansen ◽

Lene Frost Andersen ◽

Mona Bjelland ◽

Nanna Lien

Keyword(s):

Randomised Controlled Trial ◽

Vegetable Intake ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Control Group ◽

Public And Private ◽

Cluster Randomised ◽

Block Randomisation ◽

Randomised Controlled

AbstractObjective:The aim of the current study was to evaluate the effect on frequency, variety and amount of vegetables served and staff’s food-related practices in the multicomponent BRA intervention.Design:Cluster randomised controlled trial, conducted between Spring 2015 and Spring 2016. For allocation of the kindergartens, a stratified block randomisation was used. Data were collected in three ways: (i) a questionnaire for pedagogical leaders assessing the variety and frequency of vegetables served, including staff’s food-related practices assumed to be related to vegetable intake; (ii) a questionnaire for kindergarten assistants assessing staff’s food-related practices; (iii) a 5-d weighted vegetable diary assessing amount of vegetables served in a department.Setting:The target group for this study was public and private kindergartens in the counties of Vestfold and Buskerud, Norway.Participants:A total of seventy-three kindergartens participated.Results:At follow-up I, the amount of vegetables served increased by approximately 20 g per person per day (P = 0·002), and the variety in served vegetables increased by one-and-a-half kind per month (P = 0·014) in the intervention group compared to the control group. No effects on the frequency of vegetables served or on staff’s food-related practices were found.Conclusions:The BRA intervention was successful in increasing the amount and variety of vegetables served within intervention kindergartens. Further research is needed to understand the mechanisms that can affect the staff’s food-related practices.

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