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. 2021 Jan 20;6(1):e003451. doi: 10.1136/bmjgh-2020-003451

Table 1.

Characteristics of included studies

Study (year); setting, country Cohort Design Quality assessment CPM or PF study* Sample size Population Outcome Outcome prevalence (n/N)
Risk of bias Applicability concern Inclusion criteria Exclusion criteria
Outcomes including death, organ dysfunction, organ support and PICU admission
Scott (2020)40; Secondary and tertiary care hospitals, USA Hospital OPD/ED Retrospective cohort High Low CPM 2464 Age 60 days to 18 years; Clinician-suspected sepsis Hypotensive septic shock on arrival;† transfer to another centre; leaving ED before formal evaluation; incorrect registration Hypotensive septic shock‡≤24 hour 11.4% (282/2464)
Walia (2016)39; Tertiary care hospital, India Hospitalised§ Prospective cohort High High CPM 100 Age 3–36 months; Axillary temperature >36.9°C (early morning) or >37.4°C Non-infectious cause of fever; immunisation ≤2 days; immunodeficiency, autoimmune disorder In-hospital mortality; Mechanical ventilation 11.0% (11/100); 17.0% (17/100)
Aramburo (2018)26; Secondary and tertiary care hospitals, Kenya, Tanzania and Uganda Hospitalised§ Randomised controlled trial Moderate High PF 3008 Age 60 days to 12 years; history of fever or axillary temperature
≥37.5°C or <36°C; severe febrile illness¶
Non-infectious cause of illness; SAM, gastroenteritis, burns, chronic kidney disease, pulmonary oedema, intoxication, surgical conditions, receipt of isotonic fluids during the same illness In-hospital mortality (72 hours) 10.3% (309/3008)
George (2015)31; Secondary and tertiary care hospitals, Kenya, Tanzania and Uganda Hospitalised§ Randomised controlled trial High High CPM 3121 Age 60 days to 12 years; history of fever or axillary temperature
≥37.5°C or <36°C; severe febrile illness¶
Non-infectious cause of illness; SAM, gastroenteritis, burns, chronic kidney disease, pulmonary oedema, intoxication, surgical conditions, receipt of isotonic fluids during the same illness In-hospital mortality (48 hours) 9.8% (306/3121)
Scott (2012)37; Tertiary care hospital, USA Hospital OPD/ED Prospective cohort High High PF 239 Age <19 years; temperature >38.5°C or <36°C and heart rate >2 SD above normal for age; underwent phlebotomy as part of usual care Transfer from another health facility; known inborn errors of metabolism; receipt of >15 min of intravenous therapy 24 hours organ dysfunction 5.4% (13/239)
Scott (2014)36; Tertiary care hospital, USA Hospital OPD/ED Prospective cohort High High PF 239 Age <19 years; temperature >38.5°C or <36°C and heart rate >2 SD above normal for age; undergoing phlebotomy as part of routine care Transfer from another health facility; known inborn errors of metabolism; receipt of >15 min of intravenous therapy 24 hours organ dysfunction 5.4% (13/239)
Nadjm (2013)34; Secondary care hospital, Tanzania Hospitalised§ Prospective cohort Moderate High PF 3319 Age 2 months to 5 years; history of fever in last 48 hours or axillary temperature ≥37.5°C Chronic illness (excluding HIV and malnutrition); trauma; surgical conditions In-hospital mortality 5.1% (170/3319)
Mtove (2011)32; Secondary care hospital, Tanzania Hospitalised§ Prospective cohort Moderate High PF 3248 Age 2 months to 13 years; history of fever in last 48 hours or axillary temperature ≥37.5°C Chronic illness (excluding HIV and malnutrition); trauma; surgical conditions In-hospital mortality 5.0% (164/3248)
Lowlaavar (2016)42; Secondary and tertiary care hospitals, Uganda Hospitalised§ Prospective cohort High High CPM 1307 Age 6–60 months; admitted during study working hours or within 8 hours of study shift with a proven or suspected infection Previous enrolment; residence outside study catchment area In-hospital mortality 5.0% (65/1307)
Conroy (2015)27; Tertiary care hospital, Uganda Hospitalised§ Prospective cohort High High CPM 2502 Age 2 months to 5 years; history of fever in last 48 hours or axillary temperature >37.5°C None reported In-hospital mortality 4.7% (99/2089)
van Nassau (2018)38; Secondary care hospital, The Netherlands Hospitalised§ Retrospective cohort High High CPM 864 Age <18 years; suspected bacterial infection** Surgical conditions PICU transfer and/or in-hospital mortality 2.7% (24/864)
Scott (2017)35; Tertiary care hospital, USA Hospital OPD/ED Retrospective cohort Low High PF 1299 Age 60 days to 18 years; suspected sepsis††; measurement of venous lactate as part of routine care within 8 hours of ED arrival Transfer from another health facility 30-day mortality 1.9% (25/1299)
SEAIDCRN (2017)12; Tertiary care hospitals, Indonesia, Thailand and Vietnam Hospitalised§ Prospective cohort High High PF 763 Age 30 days to 18 years; modified SIRS criteria‡‡ Suspicion of hospital-acquired infection; admission to hospital within previous 30 days; transfer from another health facility after >72 hours admission; weight <3 kg; enrolment in another clinical study 28-day mortality 1.9% (14/731)
Costa de Santana (2017)28; Tertiary care hospital, Brazil Hospital OPD/ED Retrospective cohort High High PF 254 Age <13 years; axillary temperature >38.5°C; measurement of respiratory rate and heart rate on three occasions in absence of fever; measurement of leucocyte count as part of routine care Congenital malformations; bronchopulmonary dysplasia; medullary aplasia; cardiac, renal or hepatic insufficiency In-hospital mortality 1.6% (4/254)
Kwizera (2019)41; Secondary care hospital, Rwanda Hospitalised§ Prospective cohort High High CPM 949 Age 28 days to 18 years; confirmed acute infectious disease; symptom onset <14 days prior to hospital admission Allergy to antimicrobials to treat sepsis (antibiotics, artesunate, artemether-lumefantrine); terminal disease In-hospital mortality 1.5% (14/949)
Outcomes including length of stay and persistence of symptoms
Freyne (2013)30; Secondary care hospital, Ireland Hospitalised§ Prospective cohort High High PF 46 Age 6–36 months; axillary temperature >38.1°C Chronic illness; immunisation ≤2 days, antipyretic use ≤2 hours Length of stay >96 hours 26.1% (12/46)
van Nassau (2018)38; Secondary care hospital, The Netherlands Hospitalised§ Retrospective cohort High High CPM 864 Age <18 years; suspected bacterial infection** Surgical conditions Length of stay ≥7 days 22.2% (179/806)
Elshout (2015)29; General Practice (out of hours), The Netherlands Primary care Prospective cohort High High PF 480 Age 3 months to 6 years; history of fever Communication in Dutch not possible; enrolment in last 2 weeks; direct referral to hospital required Persistent fever at D3 13.1% (63/480)
Mwandama (2016)33; Community Health Workers, Malawi Primary care Prospective cohort High High PF 285 Age 2–59 months; history of fever in last 48 hours or temperature ≥37.5°C; negative malaria rapid diagnostic test Receipt of antimalarial in last 2 weeks; presence of danger signs§§ Persistent symptoms at D7 10.4% (19/182)

Studies are grouped according to the type of outcome they used: ‘hard’ (death, organ dysfunction, organ support, PICU admission) or ‘soft’ (length of stay, persistence of symptoms).

*Studies evaluating both PFs and CPMs were categorised on the basis of their primary analysis to facilitate review using the appropriate quality assessment tool.

†Hypotensive systolic blood pressure on arrival with receipt of a fluid bolus or vasoactive agent within 30 min.

‡Hypotension plus receipt of ≥30 mL/kg isotonic crystalloids or vasoactive medication.

§Only children the treating physician decided to admit were eligible but recruitment occurred at the time of admission to the health facility.

¶Respiratory distress (increased work of breathing or deep breathing) and/or impaired consciousness (coma or prostration) AND evidence of poor peripheral perfusion (capillary refill time >2 s or lower limb temperature gradient or weak radial pulse or severe tachycardia).

**Initiation of antibiotics within 24 hours of arrival in the emergency department.

††Decreased mental status or perfusion in the setting of suspected infection.

‡‡Rectal temperature >38.5°C or <35°C (or equivalent) AND heart rate >2 SD above normal for age (unless hypothermic) AND respiratory rate >2 SD above normal for age AND altered mental status OR systolic blood pressure <2 SD below normal for age OR pulse pressure <20 mm Hg OR capillary refill time >2 s OR SpO2 <95% OR leucocyte count >12×103 cells/µL or <5×103 cells/µL.

§§Convulsions, repeated vomiting, lethargy, severe anaemia or loss of consciousness.

CPM, clinical prediction model; ED, emergency department; n, number of outcomes; n, number of cases; OPD, outpatient department; PF, prognostic factor; PICU, paediatric intensive care unit; SAM, severe acute malnutrition; SEAIDCRN, Southeast Asia Infectious Disease Clinical Research Network; SIRS, systemic inflammatory response syndrome.;