Trial Outcomes & Findings for Impact of Clinical Guidance & Point-of-care CRP in Children: the ARON Project (NCT NCT04470518)

NCT ID: NCT04470518

Last Updated: 2025-04-23

Results Overview

The primary outcome is the percentage of participants who were prescribed antibiotic treatment (both immediate and delayed) at the index consultation as recorded by the treating physician.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 6750 participants
• Primary outcome timeframe: This outcome will be registered immediately at the index consultation (immediately after the intervention)
• Results posted on: 2025-04-23

Participant Flow

Unit of analysis: general practices

Participant milestones

Measure	Intervention: Diagnostic Algorithm diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice diagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).	Usual Care In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").
Overall Study STARTED	2988 82	3762 89
Overall Study COMPLETED	2988 82	3762 89
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intervention: Diagnostic Algorithm n=2988 Participants diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice diagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).	Usual Care n=3762 Participants In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").	Total n=6750 Participants Total of all reporting groups
Age, Continuous	3.7 years n=2988 Participants	3.9 years n=3762 Participants	3.75 years n=6750 Participants
Sex/Gender, Customized boy	1566 Participants n=2988 Participants	1881 Participants n=3762 Participants	3447 Participants n=6750 Participants
Sex/Gender, Customized girl	1421 Participants n=2988 Participants	1881 Participants n=3762 Participants	3302 Participants n=6750 Participants
Sex/Gender, Customized prefer not to say	1 Participants n=2988 Participants	0 Participants n=3762 Participants	1 Participants n=6750 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Belgium	2988 participants n=2988 Participants	3762 participants n=3762 Participants	6750 participants n=6750 Participants

PRIMARY outcome

Timeframe: This outcome will be registered immediately at the index consultation (immediately after the intervention)

The primary outcome is the percentage of participants who were prescribed antibiotic treatment (both immediate and delayed) at the index consultation as recorded by the treating physician.

Outcome measures

Measure	Intervention: Diagnostic Algorithm n=2988 Participants diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice diagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).	Usual Care n=3762 Participants In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").
Antibiotic Prescribing Rate at Index Consultation (Immediate or Delayed)	466 Participants	817 Participants

SECONDARY outcome

Timeframe: This outcome will be checked from the diary (via app for parents) from first day after the intervention until day of full clinical recovery (up to maximum 30 days after after the intervention)

the duration (in days) until reaching full clinical recovery

Outcome measures

Measure	Intervention: Diagnostic Algorithm n=2988 Participants diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice diagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).	Usual Care n=3762 Participants In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").
Clinical Recovery During Follow-up	4.6 days Standard Deviation 3.5	4.7 days Standard Deviation 3.6

SECONDARY outcome

Timeframe: This composite outcome will be registered immediately after the intervention and/or checked from the patient health record from the first day to day 30 after the intervention

the percentage of subjects receiving additional testing (including, but not limited to (X-Ray, blood tests, urine tests) at index consultation (day 0) and/or during follow-up (day 1 to day 30)

Outcome measures

Measure	Intervention: Diagnostic Algorithm n=2988 Participants diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice diagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).	Usual Care n=3762 Participants In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").
Additional Investigations at Index Consultation and/or During Follow-up	335 Participants	517 Participants

SECONDARY outcome

Timeframe: This outcome will be checked from the patient health record from first day to day 30 after the intervention

percentage of subjects who re-consulted their physician during follow-up (day 1 to day 30)

Outcome measures

Measure	Intervention: Diagnostic Algorithm n=2988 Participants diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice diagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).	Usual Care n=3762 Participants In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").
Re-consultation During Follow-up	770 Participants	968 Participants

SECONDARY outcome

Timeframe: This outcome will be checked from the patient health record first day to day 30 after the intervention

percentage of subjects who were prescribed antibiotic treatment during follow-up (day 1 to day 30)

Outcome measures

Measure	Intervention: Diagnostic Algorithm n=2988 Participants diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice diagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).	Usual Care n=3762 Participants In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").
Antibiotic Prescribing Rate During Follow-up	291 Participants	429 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: This outcome will be registered immediately at the index consultation

percentage of subjects receiving additional testing (including, but not limited to (X-Ray, blood tests, urine tests) at index consultation (day 0)

Outcome measures

Measure	Intervention: Diagnostic Algorithm n=2988 Participants diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice diagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).	Usual Care n=3762 Participants In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").
Additional Testing at Index Consultation	249 Participants	400 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: during follow-up from first day to day 30 after the intervention

percentage of subjects receiving additional testing (including, but not limited to (X-Ray, blood tests, urine tests) during follow-up (day 1 to day 30)

Outcome measures

Measure	Intervention: Diagnostic Algorithm n=2988 Participants diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice diagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).	Usual Care n=3762 Participants In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").
Additional Testing During Follow-up	111 Participants	149 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: This outcome will be registered immediately at the index consultation

percentage of subjects referred to hospital at index consultation (day 0)

Outcome measures

Measure	Intervention: Diagnostic Algorithm n=2988 Participants diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice diagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).	Usual Care n=3762 Participants In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").
Referral to Hospital at Day 0	24 Participants	13 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: during follow-up from first day to day 30 after the intervention

percentage of subjects referred to hospital during follow-up (day 1 to day 30)

Outcome measures

Measure	Intervention: Diagnostic Algorithm n=2988 Participants diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice diagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).	Usual Care n=3762 Participants In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").
Referral to Hospital During Follow-up	79 Participants	84 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: This outcome will be registered immediately at the index consultation

percentage of subjects admitted to hospital at index consultation (day 0)

Outcome measures

Measure	Intervention: Diagnostic Algorithm n=2988 Participants diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice diagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).	Usual Care n=3762 Participants In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").
Admission to Hospital at Day 0	7 Participants	11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: during follow-up from first day to day 30 after the intervention

percentage of subjects admitted to hospital during follow-up (day 1 to day 30)

Outcome measures

Measure	Intervention: Diagnostic Algorithm n=2988 Participants diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice diagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).	Usual Care n=3762 Participants In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").
Admission to Hospital During Follow-up	25 Participants	53 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: This outcome will be registered immediately at the index consultation

percentage of subjects who died at index consultation (day 0)

Outcome measures

Measure	Intervention: Diagnostic Algorithm n=2988 Participants diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice diagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).	Usual Care n=3762 Participants In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").
Mortality at Day 0	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: during follow-up from first day to day 30 after the intervention

percentage of subjects who died during follow-up (day 1 to day 30)

Outcome measures

Measure	Intervention: Diagnostic Algorithm n=2988 Participants diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice diagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).	Usual Care n=3762 Participants In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").
Mortality During Follow up	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: at day 7 after the intervention

percentage of subjects with full clinical recovery at day 7

Outcome measures

Measure	Intervention: Diagnostic Algorithm n=2988 Participants diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice diagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).	Usual Care n=3762 Participants In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").
Clinical Recovery at Day 7	2539 Participants	3200 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: at day 30 after the intervention

percentage of subjects with full clinical recovery at day 30

Outcome measures

Measure	Intervention: Diagnostic Algorithm n=2988 Participants diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice diagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).	Usual Care n=3762 Participants In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").
Clinical Recovery at Day 30	2967 Participants	3747 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: within 7 days after the intervention

Patient's experience through semi-structured interviews with pre-defined topic guide

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: within 7 days after the intervention

Parent's experience through semi-structured interviews with pre-defined topic guide

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: within 7 days after the intervention

Physician's experience through semi-structured interviews with pre-defined topic guide

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: will be assessed retrospectively after data collection has finished (24 months of recruitment)

Cost-effectiveness of the intervention: healthcare expenditures in terms of hospitalization, consultations, pharmaceuticals (reimbursed and non-reimbursed), productivity, quality of life

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: This outcome will be registered immediately at the index consultation

Population: missing data from 2 participants

clinicians could deviate from the proposed diagnostic algorithm. This outcome measure comprise the percentage of participants whose physician was non-adherent to the diagnostic algorithm. This is not a protocol violation, since deviating from the algorithm was a possibility if the physician deems this necessary.

Outcome measures

Measure	Intervention: Diagnostic Algorithm n=2986 Participants diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice diagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).	Usual Care In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").
Number of Participants Whose Physician Was Non-Adherent to the Diagnostic Algorithm	160 Participants	—

Adverse Events

Intervention: Diagnostic Algorithm

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 64 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intervention: Diagnostic Algorithm n=2988 participants at risk diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice diagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).	Usual Care n=3762 participants at risk In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").
Infections and infestations hospitalisation	1.1% 32/2988 • Number of events 32 • 30 days Admission to hospital at the index consultation + Admission to hospital day 1-30	1.7% 64/3762 • Number of events 64 • 30 days Admission to hospital at the index consultation + Admission to hospital day 1-30

Additional Information

Tine De Burghgraeve, PhD

Leuven Unit Health Technology Assessment Research, KU Leuven

Phone: +3216377276

Email: tine.deburghgraeve@kuleuven.be

Results disclosure agreements

• Principal investigator is a sponsor employee Investigator may only publish the Results provided that Sponsor has duly published the main Study publication. Once the main Study publication has been duly published by the Sponsor, Investigator are entitled to publish the Results provided that Sponsor has granted its prior written approval with Principal Investigator's proposed publication.
• Publication restrictions are in place

Restriction type: OTHER