Bernstein, M

Checkley, W

Colbourn, T

Graham, H

King, C

McCollum, ED

Wilson, IH

English

UCL Discovery

 1 Title: Pulse oximetry in paediatric primary care: Catalyzing implementation in 1 low-income and middle-income countries 2  3 Authors: Eric D McCollum1,2, Carina King3,4, Tim Colbourn4, Hamish 4 Graham5, Mike Bernstein6, Iain H. Wilson7, William Checkley2,8 5  6 Authors’ preferred degree and email addresses:  7 Eric D. McCollum MD    emccoll3@jhmi.edu   8 Carina King  PhD    carina.king@ki.se  9 Tim Colbourn PhD    t.colbourn@ucl.ac.uk 10 Hamish Graham PhD    Hamish.graham@rch.org.au  11 Mike Bernstein BS    mike@physio-monitor.com 12 Iain H. Wilson MB ChB, FRCA  iainhwilson@me.com 13 William Checkley MD    wcheckl1@jhmi.edu 14  15 Affiliations: 16 1. Eudowood Division of Pediatric Respiratory Sciences, Department of 17 Pediatrics, Johns Hopkins School of Medicine, Baltimore, USA 18 2. Department of International Health, Johns Hopkins Bloomberg School of 19 Public Health, Baltimore, USA 20 3. Department of Public Health Sciences, Karolinska Institutet, Stockholm, 21 Sweden 22 4. Institute for Global Health, University College London, London, UK 23 5. Centre for International Child Health, University of Melbourne, MCRI, Royal 24 Children’s Hospital, Melbourne, Australia. 25 Manuscript 2 6. Physio-Monitor, LLC, San Ramon, USA 26 7. Lifebox Foundation, London, UK 27 8. Division of Pulmonary and Critical Care, School of Medicine, Johns 28 Hopkins University, Baltimore, USA 29  30 *Corresponding Author:   emccoll3@jhmi.edu  31 Johns Hopkins Global Program for Pediatric Respiratory Sciences, Eudowood 32 Division of Pediatric Respiratory Sciences, Johns Hopkins School of 33 Medicine, Baltimore, MD 21287, USA  34  35 Role of Funding Source: Not applicable. 36  37 Ethics Committee Approval: Not applicable. 38  39 Authors contributions: EDM wrote the first draft of the comment. EDM, CK, 40 TC, HG, MB, IHW, WC provided critical review and editing of comment. All 41 authors reviewed subsequent drafts and agreed on the final version of this 42 comment. 43  44 Conflict of Interest Statements: The authors declare no competing interests. 45  46 Key words:  Oximetry, Child, Infant, Respiratory Tract Infections, Primary 47 Health Care, Developing Countries  48  3 Each year pneumonia kills more children before their fifth birthday than any 49 other infectious disease.1 To end preventable deaths of newborns and 50 children under five by 2030 (United Nations Sustainable Development Goal 51 3.2), effective primary care interventions for child pneumonia are needed.  52  53 Hypoxaemia, a low blood oxygen level, is a key risk factor for child pneumonia 54 mortality.2 In high-income settings, pulse oximeters, non-invasive portable 55 devices that measure the peripheral arterial oxyhaemoglobin saturation 56 (SpO2), have been used in routine paediatric clinical practice for over 30 57 years.3 In contrast, most paediatric primary care settings in low-income and 58 middle-income countries (LMICs) do not routinely use pulse oximeters at all.3  59  60 While barriers to implementation have included cost and weak maintenance 61 and supervision structures, a lack of policy recommendations has meant 62 pulse oximeter roll-out has lacked prioritization and investment. We argue, 63 that two knowledge gaps underpin this – device selection and high quality 64 evidence – that if addressed can further catalyze both policy and demand for 65 pulse oximetry in paediatric primary care in LMICs. 66  67 First, what do clinicians and nurses need from a pulse oximeter in LMIC 68 paediatric primary care? They need accurate devices designed to work on 69 small, distressed children even when they are moving or have compromised 70 perfusion. If pulse oximeters are to be used as screening tools among 71 children with suspected pneumonia (i.e., children with observed or reported 72 cough or difficult breathing) – our recommendation – then devices must work 73  4 quickly in overburdened facilities reading >90% of SpO2 measurements within 74 120 seconds. Devices must be robust, incorporate reusable probes, disinfect 75 easily, work despite electricity outages and with rechargeable batteries, and 76 employ a simple and intuitive interface. To date, surprisingly few pulse 77 oximeters meet these requirements and potential purchasers in LMICs have 78 no access to independent device evaluation. Instead, when LMICs procure 79 pulse oximeters they are purchased solely on price and manufacturer 80 specifications. Evidence comparing performance of different models is scarce, 81 especially regarding LMIC performance in children. Recent studies have 82 confirmed that not all inexpensive pulse oximeters are accurate,4 which 83 makes them unsuitable for paediatric use, and that even expensive devices 84 perform differently under certain conditions common to children in LMICs, 85 such as motion and low perfusion.5,6  86  87 Although formal cost effectiveness analyses are missing, basic cost 88 projections suggest oximeters may be a best buy for LMICs. Specifically, if 89 LMICs consider pulse oximeter costs on a per patient basis a $345 USD 90 investment in one quality device ($250 USD/unit) with three additional 91 paediatric probes ($25/probe) and one spare battery ($20/battery) would cost 92 less than $0.07 USD per patient over five years in a clinic serving three to four 93 children daily. LMICs must have the ability to transparently determine the 94 most appropriate device for use with children in their setting, considering cost, 95 performance, durability and usability. 96  97 Next, quality pulse oximetry and hypoxaemia data on children accessing 98  5 primary care services in LMICs is scarce. While there is evidence hypoxaemia 99 is common and that pulse oximeters effectively identify children with 100 hypoxaemia in hospitals,7,8 similar data at the primary care level is lacking, 101 especially outcome data, prevalence data, and healthcare worker device use 102 and decision-making data.  103  104 A recently published World Health Organization report indicates that outcome 105 data may soon be available from both Malawi and Bangladesh.9 Although one 106 large study in Malawi showed hypoxaemia was prevalent and government-107 sector healthcare providers effectively used pulse oximeters during paediatric 108 primary care,10 similar data is needed from other countries and regions. Local 109 data is also required to understand the optimal SpO2 threshold for hospital 110 referral. In addition to mortality risk, the optimal threshold is likely to be driven 111 by two factors, altitude and health system capacity. Although our 112 understanding is limited, children adapted to living at higher altitudes are likely 113 to be more tolerant of a lower SpO2 than children at lower altitudes.11,12 Health 114 system capacity will also differ in LMICs such that a one-size-fits-all SpO2 115 threshold may no longer be appropriate. Areas with greater health system 116 capacity may be able to accommodate higher SpO2 referral thresholds while 117 areas with more limited capacity may not. In addition to driving policy, such 118 data will inform LMICs where to locally prioritize distribution of pulse 119 oximeters, training and supervision.  120  121 Forthcoming implementation research funded by Unitaid, National Institute for 122 Health Research (RESPIRE), Save the Children (United 123  6 Kingdom)/GlaxoSmithKline (INSPIRING) aim to pilot pulse oximeters during 124 primary care in LMICs and may address some of these evidence gaps. We 125 hope these projects and others will expand our understanding of how 126 oximeters may improve LMIC paediatric primary care and help end 127 preventable child deaths from pneumonia.  128  129 Citations 130 1. Liu L, Oza S, Hogan D, Chu Y, Perin J, Zhu J, Lawn JE, Cousens S, 131 Mathers C, Black RE. Global, regional, and national causes of under-5 132 mortality in 2000-15: an updated systematic analysis with implications 133 for the Sustainable Development Goals. Lancet 2016; 388: 3027–3035.  134 2. Lazzerini M, Sonego M, Pellegrin MC. Hypoxaemia as a Mortality Risk 135 Factor in Acute Lower Respiratory Infections in Children in Low and 136 Middle-Income Countries: Systematic Review and Meta- Analysis. 137 PLos ONE 2015; 10: e0136166. 138 3. King C, Graham H, McCollum ED. Point-of-Care Pulse Oximetry for 139 Children in Low-Resource Settings. In: Atkinson K, Mabey D, eds. 140 Revolutionizing Tropical Medicine: Point of Care Tests, New Imaging 141 Technologies, and Digital Health. Hoboken, New Jersey, USA: John 142 Wiley and Sons Inc; 2019: 327-43. 143 4. Lipnick MS, Feiner JR, Au P, Bernstein M, Bickler PE. The Accuracy of 144 6 Inexpensive Pulse Oximeters Not Cleared by the Food and Drug 145 Administration: The Possible Global Public Health Implications. 146 Anesth Analg 2016; 123: 338–45. 147  7 5. Louie A, Feiner JR, Bickler PE, Rhodes L, Bernstein M, Lucero J. Four 148 Types of Pulse Oximeters Accurately Detect Hypoxia during Low 149 Perfusion and Motion. Anesthesiology 2018; 128: 520–30.  150 6. Baker K. Can improved paediatric pneumonia diagnostic aids support 151 frontline health workers in low resource settings? Large scale 152 evaluation of four respiratory rate timers and five pulse oximeters in 153 Cambodia, Ethiopia, South Sudan and Uganda. 2019. 154 https://openarchive.ki.se/xmlui/handle/10616/46833 (Accessed 155 September 26, 2019). 156 7. Subhi R, Adamson M, Campbell H, Weber M, Smith K, Duke T. The 157 prevalence of hypoxaemia among ill children in developing countries: a 158 systematic review. Lancet Infect Dis 2009; 9: 219–27. 159 8. Duke T, Wandi F, Jonathan M, Matai S, Kaupa M, Saavu M, Subhi R, 160 Peel D. Improved oxygen systems for childhood pneumonia: a 161 multihospital effectiveness study in Papua New Guinea. Lancet 2008; 162 372: 1328–33. 163 9. Exploratory meeting to review new evidence for Integrated 164 Management of Childhood Illness (IMCI) danger signs. Geneva: World 165 Health Organization, 2019. 166 https://apps.who.int/iris/bitstream/handle/10665/326100/WHO-MCA-167 19.02-eng.pdf?ua=1 (Accessed September 26, 2019) 168 10. McCollum ED, King C, Deula R, Zadutsa B, Mankhambo L, Nambiar B, 169 Makwenda C, Masache G, Lufesi N, Mwansambo C, Costello A, 170 Colbourn T. Pulse oximetry for children with pneumonia treated as 171  8 outpatients in rural Malawi. Bull World Health Organ 2016; 94: 893–172 902. 173 11. Subhi R, Smith K, Duke T. When should oxygen be given to children at 174 high altitude? A systematic review to define altitude-specific 175 hypoxaemia. Arch Dis Child 2009; 94: 6-10. 176 12. Tasker RC. Oxygen and living at altitude. Arch Dis Child 2009; 94: 1-2. 177 

Pulse oximetry in paediatric primary care in low-income and middle-income countries

https://discovery.ucl.ac.uk/id/eprint/10086446/1/Lancet%20Resp%20Med_Pulse%20Oximetry%20Commentary.pdf

Pulse oximetry in paediatric primary care in low-income and middle-income countries

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