Infectious diseases are a major cause of mortality and morbidity among the highly vulnerable occupants of residential aged care facilities (RACFs). The burden of vaccine preventable diseases (VPDs) among RACFs residents is mostly unknown and there is a lack of quality data from population-based prospective VPD surveillance in RACFs. The increasing burden of emerging and existing VPDs (eg, COVID-19, influenza, pneumococcal, pertussis and varicella-zoster) necessitates the establishment of an active enhanced surveillance system to provide real-time evidence to devise strategies to reduce the burden of VPDs in RACFs.

This study proposes a prospective active enhanced surveillance that will be implemented in RACFs across the Central Queensland (CQ) region. The study aims to measure the burden, identify aetiologies, risk factors, predictors of severe outcomes (eg, hospitalisations, mortality) and impact of the existing National Immunization Program (NIP) funded vaccines in preventing VPDs in this vulnerable population. CQ Public Health Unit (CQPHU) will implement the active surveillance by collecting demographic, clinical, pathological, diagnostic, therapeutic and clinical outcome data from the RACFs based on predefined selection criteria and case report forms as per routine public health practices. Descriptive statistics, univariate and multivariate regression analysis will be conducted to identify the predictors of morbidity and clinical outcomes following infection.

The study has been approved by the CQHHS Human Research Ethics Committee (HREC) (reference number HREC/2021/QCQ/74305). This study involves data that is routinely collected as part of the surveillance of notifiable conditions under the Public Health Act 2005. The CQHHS HREC approved a request to waive consent requirements of study participants as researchers will be provided non-identifiable data. The findings from the study will be actively disseminated through publication in peer-reviewed journals, conference presentations, social and print media, federal, state, and local authorities to reflect on the results that may facilitate revision of policy and highlight the stakeholders, funding bodies both locally and internationally.

To evaluate the diagnostic performance and feasibility of rapid antigen testing for SARS-CoV-2 detection in low-income communities.

We conducted a cross-sectional community-based diagnostic accuracy study. Community health workers, who were trained and supervised by medical technicians, performed rapid antigen tests on symptomatic individuals, and up to two additional household members in their households and diagnostic results were calibrated against the gold standard RT-PCR.

Low-income communities in Dhaka, Bangladesh.

Between 19 May 2021 and 11 July 2021, 1240 nasal and saliva samples were collected from symptomatic individuals and 993 samples from additional household members (up to two from one household).

The sensitivity of rapid antigen tests was 0.68 on nasal samples (95% CI 0.62 to 0.73) and 0.41 on saliva (95% CI 0.35 to 0.46), with specificity also higher on nasal samples (0.98, 95% CI 0.97 to 0.99) than saliva (0.87, 95% CI 0.85 to 0.90). Testing up to two additional household members increased sensitivity to 0.71 on nasal samples (95% CI 0.65 to 0.76), but reduced specificity (0.96, 95% CI 0.94 to 0.97). Sensitivity on saliva rose to 0.48 (95% CI 0.42 to 0.54) with two additional household members tested but remained lower than sensitivity on nasal samples. During the study period, testing in these low-income communities increased fourfold through the mobilisation of community health workers for sample collection.

Rapid antigen testing on nasal swabs can be effectively performed by community health workers yielding equivalent sensitivity and specificity to the literature. Household testing by community health workers in low-resource settings is an inexpensive approach that can increase testing capacity, accessibility and the effectiveness of control measures through immediately actionable results.

To define the prevalence and seizure subtypes among children with cerebral palsy (CP) in rural Bangladesh and explore barriers to optimum epilepsy control.

Prospective cohort study.

The study was conducted in Shahjadpur, a rural subdistrict of Bangladesh.

Children (

Assessments were conducted in three focused epilepsy clinics overseen by a paediatric neurologist between December 2016 and January 2018, with intervening phone and video-conference follow-ups. Details of event type, frequency and medication compliance were collected. Antiepileptic drugs (AEDs) were prescribed based on seizure type, family income, comorbidity and medication availability.

23.4% (170/726) of the BCPR cohort had a clinical diagnosis of epilepsy of whom 166 were assessed. Following the focused epilepsy clinics, 62.0% (103/166) children were clinically determined to have ongoing epileptic seizures. 62.1% (64/103) had generalised onset tonic clonic seizures, 27.2% (28/103) had focal onset seizures with impaired awareness and 10.7% (11/103) had other seizure types. None of the children with prolonged seizures (31/103) had an emergency seizure management plan. Non-epileptic events were being pharmacologically treated as seizures in 18.1% (30/166) children. Financial constraints were the main reason for non-compliance on follow-up.

Gaps in optimum epilepsy management in rural Bangladesh are amenable to improvement anchored with local healthcare workers. Training and clinical care focused on recognition of common seizure types, seizure mimics and rationalising use of available AEDs can be facilitated by better referral pathways and telehealth support.

Symptoms of anxiety and depression in Indian adolescents are common. Schools can be opportune sites for delivery of mental health interventions. India, however, is without a evidence-based and integrated whole-school mental health approach. This article describes the study design for the safeguarding adolescent mental health in India (SAMA) project. The aim of SAMA is to codesign and feasibility test a suite of multicomponent interventions for mental health across the intersecting systems of adolescents, schools, families and their local communities in India.

Our project will codesign and feasibility test four interventions to run in parallel in eight schools (three assigned to waitlist) in Bengaluru and Kolar in Karnataka, India. The primary aim is to reduce the prevalence of adolescent anxiety and depression. Codesign of interventions will build on existing evidence and resources. Interventions for adolescents at school will be universal, incorporating curriculum and social components. Interventions for parents and teachers will target mental health literacy, and also for teachers, training in positive behaviour practices. Intervention in the school community will target school climate to improve student mental health literacy and care. Intervention for the wider community will be via adolescent-led films and social media. We will generate intervention cost estimates, test outcome measures and identify pathways to increase policy action on the evidence.

Ethical approval has been granted by the National Institute of Mental Health Neurosciences Research Ethics Committee (NIMHANS/26th IEC (Behv Sc Div/2020/2021)) and the University of Leeds School of Psychology Research Ethics Committee (PSYC-221). Certain data will be available on a data sharing site. Findings will be disseminated via peer-reviewed journals and conferences.

Several studies have highlighted the effects of combination vaccines on immunisation coverage at the national or subnational level. This study examined the effects globally. Worldwide introduction of whole-cell pertussis pentavalent (wP-pentavalent) allowed estimation of incremental coverage effects of combination vaccines on the third doses of diphtheria, tetanus, pertussis (DTP3); hepatitis B (HepB3) and Haemophilus influenzae type B (Hib3).

Multicountry panel data analysis.

Country-level vaccine coverage data of WHO/UNICEF for the years 1980–2018.

Linear mixed models were used to estimate the effects of wP-pentavalent introduction by incorporating proxy variables to control for time trend and other time-dependent changes in the immunisation programmes.

Introduction of combination vaccines may have improved the coverage of DTP3 by 3percentage points(95% CI 2.5% to 3.6%) globally compared with the coverage in the pre-combination vaccine era. The comparison of coverage rates of HepB3 and Hib3 in before and after wP-pentavalent periods indicates that the introduction of combination vaccines improved the coverage by 10.1 percentage points (95% CI 8.4% to 11.7%) for HepB3 and 9.9 (95% CI 7.1% to 12.7%) for Hib3 in countries that introduced those antigens prior to adoption of wP-pentavalent. Even though the incremental coverage increase of DTP3 appears quite modest, it is still a significant result, especially because DTP vaccine has been in the national immunisation programmes of all countries for about 24 years prior to the introduction of wP-pentavalent. Additionally, the introduction of pentavalent also allowed inclusion of Hib and HepB in the vaccine schedule for a large number of countries (85 and 37, respectively, of the 102 countries included in our analysis).

The findings suggest that development of combination vaccines with additional antigens is likely to help sustain and improve coverage of existing as well as new childhood vaccines.

Participation in walking, cycling and taking public transportation without adult supervision is defined as independent mobility of children and adolescents. The association between adolescents’ independent mobility and road traffic injury (RTI) is unclear. The purpose of this study is to determine measures of adolescents’ independent mobility associated with RTIs in an urban lower middle-income setting.

Cross-sectional survey.

Schools in Karachi, Pakistan.

Adolescents aged 10–19 years in grades 6–10 were enrolled from private and public schools.

Any self-reported lifetime RTI sustained as a pedestrian, as a cyclist or while in a car or another vehicle that resulted in any first aid at home/school or consultation in a healthcare setting.

Self-reported independent mobility was assessed by four variables. (1) Any travel companion from school to home on the survey day, (2) parental permission to cross main roads alone, (3) parental permission to travel by public bus alone and (4) activity/activities outside the home on the previous weekend alone.

Data from 1264 adolescents, 10–19 years old, were included. Most were females (60%). Adolescents who had parental permission to cross main roads alone (adjusted OR (aOR) 1.39; 95% CI 1.04 to 1.86) and who participated in one or more activities outside the home alone on the previous weekend (aOR 2.61; 95% CI 1.42 to 5.13) or participated in a mixture of activities with and without adult accompaniment (aOR 2.50; 95% CI 1.38 to 4.89) had higher odds of RTIs.

Parental permission to cross main roads alone and participation in activity/activities outside the home on the previous weekend alone were two measures of independent mobility associated with higher odds of RTIs among adolescents. The study provides an understanding of the risk posed by adolescents’ independent mobility in road traffic environments.

Intubated patients in intensive care units (ICU) often express psychological distress as a result of their experiences.1 Patients often report feeling frightened of the technology being used as part of their care, and that these feelings of anxiety can persist long after critical care and hospital discharge.1 2 Understanding patients’ experiences in more depth will help practitioners understand how to develop educational and policy strategies that...

Recovery colleges (RCs) are mental health centres aimed at equipping people with skills to live a meaningful life despite the presence of mental distress. Unique to them is the aspect of cocreation; RCs are designed collaboratively with people of lived experiences of mental health and addictions and care providers. Despite established benefits, there remains a lack of empirical evidence on how RCs work and on their impact.

We aim to address this gap by designing a cocreated evaluation framework for RCs. This will be accomplished by engaging RC student/facilitators to provide perspectives on RCs/RC evaluation and cocreate a scoping review identifying evaluation gaps in the literature. Themes identified through these processes will form the evaluation framework.

Two methodologies will be used to explore RC evaluation: student/facilitator engagement and a scoping review of current published and grey literature on RC evaluation. Engagement will be achieved using a participatory action research approach consisting of informant interviews of ~25 RC students/facilitators across Canada, which will be thematically analysed. The scoping review will follow methodology described by Arksey and O’Malley modified to support cocreation. Concurrent conducting of the engagement process and scoping review will allow RC students and peer facilitators the opportunity to shape RC evaluations, address gaps in the literature and codesign an evaluation framework focused on recovery-oriented processes and outcomes mattering most to RCs students/facilitators.

Ethics approval was received for the RC student/facilitator engagement component from the Centre for Addictions and Mental Health Research Ethics Board (#042–2020) and Ontario Shores Centre for Mental Health Sciences (#20–013-B). Scoping review results will be copresented through national and international medical education conferences and published in open-access peer-reviewed journals. Furthermore, a dissemination strategy on evaluation for the national RC community will be created.

Our study identified barriers and facilitators in implementing HIV self-testing (HIVST), including the perceptions of men-having-sex-with-men (MSM) and transgender women (TGW) on HIVST. Furthermore, we explored the current knowledge, practices and potential of HIVST among the MSM and TGW populations.

Qualitative in-depth key informant interviews were administered using semistructured interviews administered in both English and Filipino. Thematic analysis of the findings was done after transcribing all audio recordings.

The study was done in the National Capital Region (NCR), Philippines using online video conferencing platforms due to mobility restrictions and lockdowns caused by the COVID-19 pandemic.

All study participants were either MSM or TGW, 18–49 years old and residing/working in NCR. Exclusion criteria include biologically born female and/or currently on pre-exposure prophylaxis, antiretroviral therapy medications or an HIV-positive diagnosis.

Twenty informants were interviewed, of which 75% were MSM, and most of them preferred the use of HIVST. Facilitators and barriers to the use of HIVST were grouped into three main themes: Acceptability, distribution and monitoring and tracking. Convenience and confidentiality, overcoming fears and normalisation of HIV testing services (HTS) in the country were the participants’ perceived facilitators of HIVST. In contrast, lack of privacy and maintenance of confidentiality during kit delivery were perceived as barriers in HIVST implementation. Moreover, social media was recognised as a powerful tool in promoting HIVST. The use of a welcoming tone and positive language should be taken into consideration due to the prevalent HIV stigma.

The identified facilitators and barriers from the study may be considered by the Philippine HTS programme implementers. The HIVST strategy may complement the current HTS. It will be very promising to involve the MSM and TGW communities and other key populations to know their HIV status by bringing testing closer to them.

In low- and middle-income countries (LMICs), food insecurity and undernutrition disproportionately affect women of reproductive age, infants and young children. The disease burden from undernutrition in these vulnerable sections of societies remains a major concern in LMICs. Biomass fuel use for cooking is also common in LMICs. Empirical evidence from high-income countries indicates that early life nutritional and environmental exposures and their effect on infant lung function are important; however, data from sub-Saharan Africa are scarce.

To estimate the association between infant lung function and household food insecurity, energy poverty and maternal dietary diversity.

Pregnant women will be recruited in an existing Health and Demographic Surveillance Site in South-West Uganda. Household food insecurity, sources and uses of energy, economic measures and maternal dietary diversity will be collected during pregnancy and after birth. Primary health outcomes will be infant lung function determined by tidal breath flow and volume analysis at 6–10 weeks of age. Infant weight and length will also be collected.

A household Food Consumption Score and Minimum Dietary Diversity for Women (MDD-W) indicator will be constructed. The involved cost of dietary diversity will be estimated based on MDD-W. The association between household level and mothers’ food access indicators and infant lung function will be evaluated using regression models. The Multidimensional Energy Poverty Index (MEPI) will be estimated and used as an indicator of households’ environmental exposures. The association between household MEPI and infant lung function will be assessed using econometric models.

Ethical approvals have been obtained from Liverpool School of Tropical Medicine (18-059), the Uganda Virus Research Institute Ethics Committee (097/2018) and Uganda National Council for Science and Technology (SS 4846). Study results will be shared with participants, policy-makers, other stakeholders and published in peer-reviewed journals.

Medical waste management (MWM)-related factors affecting the health of medical waste handlers (MWHs) and their health risks in low and middle-income countries (LMICs) are an important public health concern. Although studies of MWM-related factors and health risks among MWHs in LMICs are available, literature remains undersynthesised and knowledge fragmented. This systematic review will provide a comprehensive synthesis of evidence regarding the individual, system and policy-level MWM-related factors that affect MWHs’ health and their experiences of health risks in LMICs.

All qualitative studies published in peer-reviewed journals between 1 July 2011 and 30 June 2021 with full texts available and accessible will be included in the review. Seven specific electronic databases (eg, Scopus, Ovid MEDLINE, EMBASE, Global Health, CINAHL, ProQuest and PsycINFO) will be searched. Two authors will review the citations and full texts, extract data and complete the quality appraisal independently. A third reviewer will check discrepancies when a consensus cannot be reached on differences between the two reviewers. Data extraction will be conducted using the Joanna Briggs Institute standardised data extraction form for qualitative research. The quality of articles will be assessed using a Critical Appraisal Skills Programme checklist. Results from eligible articles will be synthesised into a set of findings using the thematic framework analysis approach and will be reported according to the Enhancing Transparency in Reporting the Synthesis of Qualitative Research statement.

This review is based on published articles, which does not require ethical approval because there is no collection of primary data. Findings from this review will be published in a peer-reviewed journal and presented at relevant public health conferences. This protocol has been registered with the International Prospective Register of Systematic Reviews (PROSPERO).

CRD42020226851.

To determine the feasibility and acceptability of conducting a randomised trial on the effects of myo-inositol in preventing gestational diabetes in high-risk pregnant women.

A multicentre, double-blind, placebo-controlled, pilot randomised trial with nested qualitative evaluation.

Five inner city UK National Health Service hospitals

Multiethnic pregnant women at 12⁺⁰ and 15⁺⁶ weeks’ gestation with risk factors for gestational diabetes.

2 g of myo-inositol or placebo, both included 200 µg folic acid, twice daily until delivery.

Rates of recruitment, randomisation, adherence and follow-up.

Glycaemic indices (including homoeostatic model assessment-insulin resistance HOMA-IR), gestational diabetes (diagnosed using oral glucose tolerance test at 28 weeks and by delivery), maternal, perinatal outcomes, acceptability of intervention and costs.

Of the 1326 women screened, 58% (773/1326) were potentially eligible, and 27% (205/773) were recruited. We randomised 97% (198/205) of all recruited women (99 each in intervention and placebo arms) and ascertained outcomes in 90% of women (178/198) by delivery. The mean adherence was 52% (SD 44) at 28 weeks’ and 34% (SD 41) at 36 weeks’ gestation. HOMA-IR and serum insulin levels were lower in the myo-inositol vs placebo arm (mean difference –0.6, 95% CI –1.2 to 0.0 and –2.69, 95% CI –5.26 to –0.18, respectively). The study procedures were acceptable to women and healthcare professionals. Women who perceived themselves at high risk of gestational diabetes were more likely to participate and adhere to the intervention. The powder form of myo-inositol and placebo, along with nausea in pregnancy were key barriers to adherence.

A future trial on myo-inositol versus placebo to prevent gestational diabetes is feasible. The intervention will need to be delivered in a non-powder form to improve adherence. There is a signal for efficacy in reducing insulin resistance in pregnancy with myo-inositol.

ISRCTN48872100.

Complementary feeding (CF) is defined as the period from when exclusive breast milk and formula are no longer sufficient for meeting the infant’s nutritional needs. The CF period occurs from birth to 23 months of age. Though the recommended guidelines for introducing CF is from around 6 months of age, data indicates that some infants are introduced to food earlier than 6 months which can predispose children to obesity and overweight. Obesity in ethnic minority groups (EMG) is higher than their native counterparts and often tracks into adulthood. Hence, our aim was to conduct a systematic review and meta-analysis on the available literature to identify the risk of childhood overweight/obesity associated with CF practices concerning their timing, as well as the frequency and type of CF food introduced. We focused specifically on EMG children living in high-income countries.

A methodological literature search surrounding childhood obesity and overweight (COO) risk associated with CF practices will be conducted in May 2021 following Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. The following academic databases will be methodologically searched: PubMed, EMBASE, PsycINFO, CINAHL, SCOPUS, Cochrane Library and the WHO Global Index Medicus. Three independent researchers will be involved in independent screening and review the included articles based on the predefined inclusion and exclusion criteria. Where conflicts arise during the screening process, it will be resolved through discourse until a consensus is reached. Information on CF practices and anthropometric measurements will be extracted to ascertain the risk of COO. For this study, WHO body mass index for age and sex percentiles, Centers for Disease Control and Prevention classification and other recognised country-specific classifications will be utilised for the outcome.

Formal ethical approval is not needed as the results will be drawn from currently available published literature. Outcomes of the review will be shared through peer-reviewed publications.

CRD42021246029.

To determine characteristics associated with COVID-19 vaccine coverage among individuals aged 50 years and above in England since the beginning of the programme.

Observational cross-sectional study assessed by logistic regression and mean prevalence margins.

COVID-19 vaccinations delivered in England from 8 December 2020 to 17 May 2021.

30 624 257/61 967 781 (49.4%) and 17 360 045/61 967 781 (28.1%) individuals in England were recorded as vaccinated in the National Immunisation Management System with a first dose and a second dose of a COVID-19 vaccine, respectively.

Vaccination status with COVID-19 vaccinations.

Proportion, adjusted ORs and mean prevalence margins for individuals not vaccinated with dose 1 among those aged 50–69 years and dose 1 and 2 among those aged 70 years and above.

Of individuals aged 50 years and above, black/African/Caribbean ethnic group was the least likely of all ethnic groups to be vaccinated with dose 1 of the COVID-19 vaccine. However, of those aged 70 years and above, the odds of not having dose 2 was 5.53 (95% CI 5.42 to 5.63) and 5.36 (95% CI 5.29 to 5.43) greater among Pakistani and black/African/Caribbean compared with white British ethnicity, respectively. The odds of not receiving dose 2 was 1.18 (95% CI 1.16 to 1.20) higher among individuals who lived in a care home compared with those who did not. This was the opposite to that observed for dose 1, where the odds of being unvaccinated was significantly higher among those not living in a care home (0.89 (95% CI 0.87 to 0.91)).

We found that there are characteristics associated with low COVID-19 vaccine coverage. Inequalities, such as ethnicity are a major contributor to suboptimal coverage and tailored interventions are required to improve coverage and protect the population from SARS-CoV-2.

Cholecystectomy is one of the most common surgical procedures performed worldwide to treat gallstone-related disease. Postcholecystectomy diarrhoea (PCD) is a well-reported phenomenon, however, the actual rate, predictive factors and mechanism of action have not been well determined. A systematic review was undertaken to determine the rate and predictive factors associated with diarrhoea in the postcholecystectomy setting.

The review was conducted according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol. Databases searched included Medline, Embase, Pubmed, Cochrane and Google Scholar up to 29 September 2020. The inclusion criteria consisted of cohort studies or randomised trials which investigated the rate of PCD and predictive factors. Case reports, case series, conference abstracts and expert opinion pieces were excluded as were other systematic reviews as all the original articles from those reviews were included in this review. Papers that did not include PCD as a separate entity were excluded. Bias assessment was performed using the Newcastle-Ottawa Scale for cohort studies and the Cochrane risk of bias tool for randomised controlled trials as appropriate. Data were extracted by two authors (AF and JAA) and an overall rate of PCD was calculated. Predictive factors were also extracted and compared between studies.

1204 papers were obtained and 21 were found to contain relevant information about PCD, including the number of patients developing diarrhoea, method of symptom assessment and time of onset postcholecystectomy. A pooled total of 3476 patients were included across the identified studies with 462 (13.3%) patients developing PCD. Possible predictive factors varied across all studies, with characteristics such as gender, age and weight of patients postulated as being predictive of PCD, with no agreement across studies.

PCD is therefore relatively common (13.3%). This has important implications for patient consent. Patients ought to be investigated early for bile acid diarrhoea in suspected PCD. More studies are required to determine the possible predictive factors for PCD. Limitations of the study included that most studies were not powered for calculation of PCD, and assessment methods between studies varied.

CRD42019140444.

To measure the readiness of health facilities in Papua New Guinea (PNG) to provide obstetric care and other maternal health services.

Cross-sectional study involving random sample of health centres, district/rural hospitals (levels 3 and 4 facilities) and all upper-level hospitals operational at the time of survey. Structured questionnaires were used to collect data from health facilities.

Health facilities in PNG. Facility administrators and other facility personnel were interviewed. Number of facility personnel interviewed was usually one for health centres and two or more for hospitals.

19 upper-level facilities (levels 5–7, provincial, regional and national hospitals) and 60 lower-level facilities (levels 3 and 4, health centres and district/rural hospitals).

Four service-types were used to understand readiness of surveyed health facilities in the provision of maternity care including obstetric care services: (1) facility readiness to provide clinical services; (2) availability of family planning items; (3) availability of maternal and neonatal equipment and materials; and (4) ability to provide emergency obstetric care (EmOC).

56% of lower-level facilities were not able to provide basic emergency obstetric care (BEmOC). Even among higher-level facilities, 16% were not able to perform one or more of the functions required to be considered a BEmOC provider. 11% of level 3 and 4 health facilities were able to provide comprehensive emergency obstetric care (CEmOC) as compared with 83% of higher-level facilities.

Given the high fertility rate and maternal mortality ratio (MMR) in PNG, lack of BEmOC at the first level inpatient service providers is a major concern. To improve access to EmOC, level 3 and 4 facilities should be upgraded to at least BEmOC providers. Significant reduction in MMR will require improved access to CEmOC and optimal geographic location approach can identify facilities to be upgraded.

The WHO’s Integrated Management of Childhood Illnesses (IMCI) algorithm for diagnosis of child pneumonia relies on counting respiratory rate and observing respiratory distress to diagnose childhood pneumonia. IMCI case defination for pneumonia performs with high sensitivity but low specificity, leading to overdiagnosis of child pneumonia and unnecessary antibiotic use. Including lung auscultation in IMCI could improve specificity of pneumonia diagnosis. Our objectives are: (1) assess lung sound recording quality by primary healthcare workers (HCWs) from under-5 children with the Feelix Smart Stethoscope and (2) determine the reliability and performance of recorded lung sound interpretations by an automated algorithm compared with reference paediatrician interpretations.

In a cross-sectional design, community HCWs will record lung sounds of ~1000 under-5-year-old children with suspected pneumonia at first-level facilities in Zakiganj subdistrict, Sylhet, Bangladesh. Enrolled children will be evaluated for pneumonia, including oxygen saturation, and have their lung sounds recorded by the Feelix Smart stethoscope at four sequential chest locations: two back and two front positions. A novel sound-filtering algorithm will be applied to recordings to address ambient noise and optimise recording quality. Recorded sounds will be assessed against a predefined quality threshold. A trained paediatric listening panel will classify recordings into one of the following categories: normal, crackles, wheeze, crackles and wheeze or uninterpretable. All sound files will be classified into the same categories by the automated algorithm and compared with panel classifications. Sensitivity, specificity and predictive values, of the automated algorithm will be assessed considering the panel’s final interpretation as gold standard.

The study protocol was approved by the National Research Ethics Committee of Bangladesh Medical Research Council, Bangladesh (registration number: 09630012018) and Academic and Clinical Central Office for Research and Development Medical Research Ethics Committee, Edinburgh, UK (REC Reference: 18-HV-051). Dissemination will be through conference presentations, peer-reviewed journals and stakeholder engagement meetings in Bangladesh.

NCT03959956.