Challenges in the diagnosis of paediatric pneumonia in intervention field trials: recommendations from a pneumonia field trial working group

Abstract

Pneumonia is a leading killer of children younger than 5 years despite high vaccination coverage, improved nutrition, and widespread implementation of the Integrated Management of Childhood Illnesses algorithm. Assessing the effect of interventions on childhood pneumonia is challenging because the choice of case definition and surveillance approach can affect the identification of pneumonia substantially. In anticipation of an intervention trial aimed to reduce childhood pneumonia by lowering household air pollution, we created a working group to provide recommendations regarding study design and implementation. We suggest to, first, select a standard case definition that combines acute (≤14 days) respiratory symptoms and signs and general danger signs with ancillary tests (such as chest imaging and pulse oximetry) to improve pneumonia identification; second, to prioritise active hospital-based pneumonia surveillance over passive case finding or home-based surveillance to reduce the risk of non-differential misclassification of pneumonia and, as a result, a reduced effect size in a randomised trial; and, lastly, to consider longitudinal follow-up of children younger than 1 year, as this age group has the highest incidence of severe pneumonia.

The Importance of Respiratory Rate Monitoring: From Healthcare to Sport and Exercise

“…A growing body of evidence suggests that respiratory rate, also known as respiratory frequency (f R ), is a fundamental variable to be monitored in different fields. In healthcare, f R is a vital sign which provides information on clinical deterioration, predicts cardiac arrest, and supports the diagnosis of severe pneumonia [1][2][3][4][5]. Furthermore, f R responds to a variety of stressors, including emotional stress, cognitive load, cold, and hyperthermia [6][7][8][9].…”

Design and conduct of facility-based surveillance for severe childhood pneumonia in the Household Air Pollution Intervention Network (HAPIN) trial

“…WHO-defined severe pneumonia) that has the potential to impact global policies coupled with objective physiological (hypoxaemia) and imaging criteria. This definition is reliable, reproducible globally, optimises the chance of detecting an intervention effect and has been recommended by paediatric pneumonia experts for application in field settings [18]. Sentinel facility surveillance by HAPIN clinical staff, including standardised direct child observation and caregiver interviews, improves the completeness and standardisation of data collection for case screening.…”

“…Our pneumonia surveillance and case ascertainment strategy is based on three workshops with external experts to discuss the current challenges related to defining and identifying pneumonia in intervention trials [18]. These workshops resulted in four key strategic decisions.…”

Design and Rationale of the HAPIN Study: A Multicountry Randomized Controlled Trial to Assess the Effect of Liquefied Petroleum Gas Stove and Continuous Fuel Distribution

“…For the purposes of the HAPIN trial, a case of severe pneumonia is adapted from the revised WHO classification of childhood pneumonia (WHO 2014b) and is consistent with expert opinion (Goodman et al 2019;WHO 2014a). This classification includes two independent algorithms for severe pneumonia, which we have enriched with more objective imaging and pulse oximetry criteria (Simkovich et al, in press).…”

“…Only three studies have quantified the association between HAP and child developmental outcomes (Suter et al 2018;Dix-Cooper et al 2012;Munroe and Gauvain 2012), and only two quantified the association between HAP and stunting (Wylie et al 2017;Kim et al 2017), but none have done so using a longitudinal approach in children under 1 years of age. Our case definition of pneumonia is designed to balance the need for sensitivity and specificity (Goodman et al 2019).…”