1,066
Views
0
CrossRef citations to date
0
Altmetric
Study design article

The Tools for Integrated Management of Childhood Illness (TIMCI) study protocol: a multi-country mixed-method evaluation of pulse oximetry and clinical decision support algorithms

ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, , ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, , ORCID Icon, ORCID Icon, , , ORCID Icon, ORCID Icon, , , ORCID Icon, , ORCID Icon, , ORCID Icon, ORCID Icon & show all
Article: 2326253 | Received 03 Aug 2023, Accepted 25 Feb 2024, Published online: 29 Apr 2024

References

  • UN IGME. Levels & trends in child mortality report 2022: estimates developed by the united nations inter-agency group for child mortality estimation. New York: UNICEF; 2023.
  • Costello AM, Dalglish SL, on behalf of the Strategic Review Study Team. Towards a grand convergence for child survival and health: a strategic review of options for the future building on lessons learnt from IMNCI. Geneva: WHO; 2016.
  • World Health Organization. Integrated management of childhood illness: chart booklet. Geneva: WHO; 2014.
  • Graham HR, Kamuntu Y, Miller J, Barrett A, Kunihira B, Engol S, et al. Hypoxaemia prevalence and management among children and adults presenting to primary care facilities in Uganda: a prospective cohort study. PLoS Glob Public Health. 2022;2:e0000352. doi: 10.1371/journal.pgph.0000352
  • Colbourn T, King C, Beard J, Phiri T, Mdala M, Zadutsa B, et al. Predictive value of pulse oximetry for mortality in infants and children presenting to primary care with clinical pneumonia in rural Malawi: a data linkage study. PLoS Med. 2020 Oct;17:e1003300. doi: 10.1371/journal.pmed.1003300
  • Tesfaye SH, Gebeyehu Y, Loha E, Johansson KA, Lindtjørn B. Pulse oximeter with integrated management of childhood illness for diagnosis of severe childhood pneumonia at rural health institutions in Southern Ethiopia: results from a cluster-randomised controlled trial. BMJ Open. 2020 Jun 21;10:e036814. doi: 10.1136/bmjopen-2020-036814
  • Lazzerini M, Sonego M, Pellegrin MC, Bhutta ZA. Hypoxaemia as a mortality risk factor in acute lower respiratory infections in children in low and middle-income countries: systematic review and meta-analysis. PLoS One. 2015;10:e0136166. doi: 10.1371/journal.pone.0136166
  • Rojas-Reyes MX, Granados Rugeles C, Charry-Anzola LP. Oxygen therapy for lower respiratory tract infections in children between 3 months and 15 years of age. Cochrane Database Syst Rev. 2014 Dec 10;2014:Cd005975. doi: 10.1002/14651858.CD005975.pub3
  • Duke T, Subhi R, Peel D, Frey B. Pulse oximetry: technology to reduce child mortality in developing countries. Ann Trop Paediatr. 2009 Sep;29:165–16. doi: 10.1179/027249309X12467994190011
  • Ginsburg AS, Van Cleve WC, Thompson MI, English M. Oxygen and pulse oximetry in childhood pneumonia: a survey of healthcare providers in resource-limited settings. J Trop Pediatr. 2012 Oct;58:389–393. doi: 10.1093/tropej/fmr103
  • Floyd J, Wu L, Hay Burgess D, Izadnegahdar R, Mukanga D, Ghani AC. Evaluating the impact of pulse oximetry on childhood pneumonia mortality in resource-poor settings. Nature. 2015 Dec 3;528:S53–9. doi: 10.1038/nature16043
  • McCollum ED, King C, Deula R, Zadutsa B, Mankhambo L, Nambiar B, et al. Pulse oximetry for children with pneumonia treated as outpatients in rural Malawi. Bull World Health Organ. 2016 Dec 1;94:893–902. doi: 10.2471/BLT.16.173401
  • Orimadegun AE, Ogunbosi BO, Carson SS. Prevalence and predictors of hypoxaemia in respiratory and non-respiratory primary diagnoses among emergently ill children at a tertiary hospital in South Western Nigeria. Trans R Soc Trop Med Hyg. 2013 Nov;107:699–705. doi: 10.1093/trstmh/trt082
  • Graham H, Bakare AA, Ayede AI, Oyewole OB, Gray A, Peel D, et al. Hypoxaemia in hospitalised children and neonates: a prospective cohort study in Nigerian secondary-level hospitals. EClinicalMedicine. 2019 Nov;16:51–63. doi: 10.1016/j.eclinm.2019.10.009
  • Chew R, Zhang M, Chandna A, Lubell Y. The impact of pulse oximetry on diagnosis, management and outcomes of acute febrile illness in low-income and middle-income countries: a systematic review. BMJ Glob Health. 2021 Nov;6:e007282. doi: 10.1136/bmjgh-2021-007282
  • Kruger C, Heinzel-Gutenbrunner M, Ali M. Adherence to the integrated management of childhood illness guidelines in Namibia, Kenya, Tanzania and Uganda: evidence from the national service provision assessment surveys. BMC Health Serv Res. 2017 Dec 13;17:822. doi: 10.1186/s12913-017-2781-3
  • Horwood C, Voce A, Vermaak K, Rollins N, Qazi S. Experiences of training and implementation of integrated management of childhood illness (IMCI) in South Africa: a qualitative evaluation of the IMCI case management training course. BMC Pediatr. 2009 Oct 1;9:62. doi: 10.1186/1471-2431-9-62
  • Lange S, Mwisongo A, Maestad O. Why don’t clinicians adhere more consistently to guidelines for the integrated management of childhood illness (IMCI)? Soc Sci Med. 2014 Mar;104:56–63. doi: 10.1016/j.socscimed.2013.12.020
  • Bjornstad E, Preidis GA, Lufesi N, Olson D, Kamthunzi P, Hosseinipour MC, et al. Determining the quality of IMCI pneumonia care in Malawian children. Paediatr Int Child Health. 2014 Feb;34:29–36.
  • World Health Organization. WHO guideline: recommendations on digital interventions for health system strengthening. Geneva: WHO; 2019.
  • Shao AF, Rambaud-Althaus C, Samaka J, Faustine AF, Perri-Moore S, Swai N, et al. New algorithm for managing childhood illness using mobile technology (ALMANACH): a controlled non-inferiority study on clinical outcome and antibiotic use in Tanzania. PLoS One. 2015;10:e0132316. doi: 10.1371/journal.pone.0132316
  • Keitel K, Kagoro F, Samaka J, Masimba J, Said Z, Temba H, et al. A novel electronic algorithm using host biomarker point-of-care tests for the management of febrile illnesses in Tanzanian children (e-POCT): a randomized, controlled non-inferiority trial. PLoS Med. 2017 Oct;14:e1002411. doi: 10.1371/journal.pmed.1002411
  • Schmitz T, Beynon F, Musard C, Kwiatkowski M, Landi M, Ishaya D, et al. Effectiveness of an electronic clinical decision support system in improving the management of childhood illness in primary care in rural Nigeria: an observational study. BMJ Open. 2022 Jul 21;12:e055315. doi: 10.1136/bmjopen-2021-055315
  • Sarrassat S, Lewis JJ, Some AS, Somda S, Cousens S, Blanchet K. An integrated eDiagnosis approach (IeDA) versus standard IMCI for assessing and managing childhood illness in Burkina Faso: a stepped-wedge cluster randomised trial. BMC Health Serv Res. 2021 Apr 16;21:354. doi: 10.1186/s12913-021-06317-3
  • Soremekun S, Kallander K, Lingam R, Branco AC, Batura N, Strachan DL, et al. Improving outcomes for children with malaria, diarrhoea and pneumonia in Mozambique: a cluster randomised controlled trial of the inSCALE technology innovation. PLoS Digital Health. 2023 Jun;2:e0000235.
  • Agarwal S, Glenton C, Tamrat T, Henschke N, Maayan N, Fonhus MS, et al. Decision-support tools via mobile devices to improve quality of care in primary healthcare settings. Cochrane Database Syst Rev. 2021 Jul 27;7:CD012944.
  • Odendaal WA, Anstey Watkins J, Leon N, Goudge J, Griffiths F, Tomlinson M, et al. Health workers’ perceptions and experiences of using mHealth technologies to deliver primary healthcare services: a qualitative evidence synthesis. Cochrane Database Syst Rev. 2020 Mar 26;3:CD011942. doi: 10.1002/14651858.CD011942.pub2
  • World Health Organization. Standards for improving the quality of care for children and young adolescents in health facilities. Geneva: WHO; 2018.
  • Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17:88. doi: 10.1186/s12913-017-2031-8
  • Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42.
  • De Silva MJ, Breuer E, Lee L, Asher L, Chowdhary N, Lund C, et al. Theory of change: a theory-driven approach to enhance the medical research council’s framework for complex interventions. Trials. 2014 Jul 5;15:267. doi: 10.1186/1745-6215-15-267
  • Taplin DH, Clark H, Collins E, Colby DC. Theory of change technical papers: a series of papers to support development of theories of change based on practice in the field. New York: Center for Human Environment; 2013.
  • Pawson R, Tilley N. Realist evaluation. London: British Cabinet Office; 2004.
  • Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: medical research council guidance. BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258
  • Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586
  • The DHS Program. Service provision assessment questionnaires. 2012 [cited 2019]. Available from: https://dhsprogram.com/methodology/Survey-Types/SPA.cfm
  • India State-Level Disease Burden Initiative Child Mortality C. Subnational mapping of under-5 and neonatal mortality trends in India: the global burden of disease study 2000–17. Lancet. 2020 May 23;395:1640–1658.
  • UNICEF. UNICEF country data profiles. 2022 [cited 2023]. Available from: https://data.unicef.org/country/
  • Ministry of Health (MoH) [Tanzania Mainland], Ministry of Health (MoH) [Zanzibar], National Bureau of Statistics (NBS), Office of the Chief Government Statistician (OCGS), ICF. Tanzania demographic and health survey and malaria indicator survey 2022 key indicators report. Dodoma (Tanzania): MoH, NBS, OCGS, and ICF; 2023.
  • Acare Technology Co. Ltd. Acare AH-MX. [ cited 2022]. Available from: https://www.acaretech.com/product_872390.html
  • Uwemedimo OT, Lewis TP, Essien EA, Chan GJ, Nsona H, Kruk ME, et al. Distribution and determinants of pneumonia diagnosis using integrated management of childhood illness guidelines: a nationally representative study in Malawi. BMJ Glob Health. 2018;3:e000506. doi: 10.1136/bmjgh-2017-000506
  • Emdin CA, Mir F, Sultana S, Kazi AM, Zaidi AK, Dimitris MC, et al. Utility and feasibility of integrating pulse oximetry into the routine assessment of young infants at primary care clinics in Karachi, Pakistan: a cross-sectional study. BMC Pediatr. 2015 Sep 30;15:141.
  • Boyd N, King C, Walker IA, Zadutsa B, Bernstein M, Ahmed S, et al. Usability testing of a reusable pulse oximeter probe developed for health-care workers caring for children < 5 years old in low-resource settings. Am J Trop Med Hyg. 2018 Oct;99:1096–1104.
  • World Health Organization. Oxygen therapy for children. Geneva: WHO; 2016.
  • Tan R, Cobuccio L, Beynon F, Levine GA, Vaezipour N, Luwanda LB, et al. ePOCT+ and the medAL-suite: development of an electronic clinical decision support algorithm and digital platform for pediatric outpatients in low- and middle-income countries. PLoS Digital Health. 2023 Jan;2:e0000170.
  • The dynamic study - digital tools supporting the project: medAL software suite. [ cited 2022]. Available from: https://dynamic-study.com/
  • Ilboudo TP, Chou YJ, Huang N. Compliance with referral for curative care in rural Burkina Faso. Health Policy Plan. 2012 May;27:256–264. doi: 10.1093/heapol/czr041
  • Pagel C, Prost A, Lewycka S, Das S, Colbourn T, Mahapatra R, et al. Intracluster correlation coefficients and coefficients of variation for perinatal outcomes from five cluster-randomised controlled trials in low and middle-income countries: results and methodological implications. Trials. 2011 Jun 14;12:151. doi: 10.1186/1745-6215-12-151
  • Semrau KEA, Hirschhorn LR, Marx Delaney M, Singh VP, Saurastri R, Sharma N, et al. Outcomes of a coaching-based WHO safe childbirth checklist program in India. N Engl J Med. 2017 Dec 14;377:2313–2324. doi: 10.1056/NEJMoa1701075
  • World Health Organization. Ethical issues in patient safety research. Geneva: WHO; 2013.
  • Wiens BL. A fixed sequence Bonferroni procedure for testing multiple endpoints. Pharm Stat. 2003;2:211–215. doi: 10.1002/pst.64
  • Wiens BL, Dmitrienko A. The fallback procedure for evaluating a single family of hypotheses. J Biopharm Stat. 2005;15:929–942. doi: 10.1080/10543400500265660
  • Alosh M, Bretz F, Huque M. Advanced multiplicity adjustment methods in clinical trials. Stat Med. 2014 Feb 20;33:693–713. doi: 10.1002/sim.5974
  • Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts. BMC Med Res Methodol. 2017 Dec 6;17:162.
  • Sullivan TR, White IR, Salter AB, Ryan P, Lee KJ. Should multiple imputation be the method of choice for handling missing data in randomized trials? Stat Methods Med Res. 2018 Sep;27:2610–2626. doi: 10.1177/0962280216683570
  • Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013 Sep 18;13:117. doi: 10.1186/1471-2288-13-117