Impact of pulse oximetry on hospital referral acceptance in children under 5 with severe pneumonia in rural Pakistan (district Jamshoro): protocol for a cluster randomised trial

BackgroundPneumonia is a leading cause of death among children under 5 specifically in South Asia and sub-Saharan Africa. Hypoxaemia is a life-threatening complication among children under 5 with pneumonia. Hypoxaemia increases risk of mortality by 4.3 times in children with pneumonia than those without hypoxaemia. Prevalence of hypoxaemia varies with geography, altitude and severity (9%–39% Asia, 3%–10% African countries). In this protocol paper, we describe research methods for assessing impact of Lady Health Workers (LHWs) identifying hypoxaemia in children with signs of pneumonia during household visits on acceptance of hospital referral in district Jamshoro, Sindh.Methods and analysisA cluster randomised controlled trial using pulse oximetry as intervention for children with severe pneumonia will be conducted in community settings. Children aged 0–59 months with signs of severe pneumonia will be recruited by LHWs during routine visits in both intervention and control arms after consent. Severe pneumonia will be defined as fast breathing and/or chest in-drawing, and, one or more danger sign and/or hypoxaemia (Sa02 <92%) in PO (intervention) group and fast breathing and/or chest in-drawing and one or more danger sign in clinical signs (control) group. Recruits in both groups will receive a stat dose of oral amoxicillin and referral to designated tertiary health facility. Analysis of variance will be used to compare baseline referral acceptance in both groups with that at end of study.Ethics and disseminationEthical approval was granted by the Ethics Review Committee of the Aga Khan University (4722-Ped-ERC-17), Karachi. Study results will be shared with relevant government and non-governmental organisations, presented at national and international research conferences and published in international peer-reviewed scientific journals.Trial registration numberNCT03588377.

Download Full-text

Active Play in After-school Programmes: development of an intervention and description of a matched-pair cluster-randomised trial assessing physical activity play in after-school programmes

BMJ Open ◽

10.1136/bmjopen-2017-016585 ◽

2017 ◽

Vol 7 (8) ◽

pp. e016585 ◽

Cited By ~ 4

Author(s):

Kirsti Riiser ◽

Sølvi Helseth ◽

Hanna Ellingsen ◽

Bjørg Fallang ◽

Knut Løndal

Keyword(s):

Physical Activity ◽

First Graders ◽

Randomised Trial ◽

Matched Pair ◽

After School ◽

Cluster Randomised Trial ◽

Small Scale ◽

Control Group ◽

Active Play ◽

Cluster Randomised

IntroductionInterventions delivered in after-school programmes (ASPs) have the potential to become a means of ensuring adequate physical activity among schoolchildren. This requires a motivational climate, allowing for self-determined play. If trained, ASP staff may represent a valuable resource for supporting such play. Increasing knowledge and supportive skills among ASP staff may also potentially increase their motivation for work. The purpose of this article is to describe the development of the ‘Active Play in ASP’ intervention, which aims to promote physical activity among first graders attending ASP, and to present a protocol for a matched-pair cluster-randomised trial to evaluate the intervention.Methods and analysisInformed by experiences from practice, evidence-based knowledge and theory, the intervention was developed in a stepwise process including focus group meetings and a small-scale pilot test. The intervention contains a course programme for ASP staff to increase their skills in how to support physical activity through play. In a cluster randomised controlled trial, the ASPs will be matched and randomly allocated to receive the 7-month intervention or to a control group. Outcomes will be assessed at baseline, after 7 and 19 months. First graders attending the ASPs included are eligible. The primary outcome will be accelerometer-determined minutes in moderate to vigorous physical activity in the ASP. The study uses a mixed methods approach including observations and interviews to provide rich descriptions of the concept of children's physical activity in ASP. Moreover, the trial will assess whether the ASP staff benefits from participation in the intervention in terms of increased work motivation. Lastly, process evaluations of programme fidelity, satisfaction and suggestions on improvement will be performed.Ethics and disseminationThe study is approved by the Data Protection Official for Research (reference no 46008). Results will be presented in conferences and peer-reviewed journals.Trial registration numberClinical Trials (NCT02954614), pre-results.

Download Full-text

Effects of the Informed Health Choices primary school intervention on the ability of children in Uganda to assess the reliability of claims about treatment effects, one-year follow-up: a cluster-randomised trial

10.21203/rs.2.12516/v1 ◽

2019 ◽

Cited By ~ 1

Author(s):

Allen Nsangi ◽

Daniel Semakula ◽

Andrew David Oxman ◽

Astrid Austvoll- Dalghren ◽

Matt Oxman ◽

...

Keyword(s):

Primary School ◽

Primary Schools ◽

Randomised Trial ◽

Multiple Choice ◽

Cluster Randomised Trial ◽

Control Group ◽

Cluster Randomised ◽

Health Choices ◽

The Mean ◽

One Year

Abstract Introduction We evaluated an intervention designed to teach 10 to 12-year-old primary school children to assess claims about the effects of treatments (any action intended to maintain or improve health). We report here on outcomes measured one year after the intervention. Methods In this cluster-randomised trial, we included primary schools in the central region of Uganda that taught year-five children (aged 10 to 12 years). We randomly allocated a representative sample of eligible schools to either an intervention or control group. Intervention schools received the Informed Health Choices primary school resources (textbooks, exercise books, and a teachers’ guide). The primary outcome, measured at the end of the school term and again after one year, was the mean score on a test with two multiple-choice questions for each of the 12 concepts and the proportion of children with passing scores. Results We assessed 2960 schools for eligibility; 2029 were eligible, and a random sample of 170 were invited to recruitment meetings. After recruitment meetings, 120 eligible schools consented and were randomly assigned to either the intervention group (n=60, 76 teachers and 6383 children) or control group (n=60, 67 teachers and 4430 children). After one year, the mean score in the multiple-choice test for the intervention schools was 68.7% compared to 53.0% for the control schools (adjusted mean difference 16.7%, 95% CI 13.9 to 19.5; p<0·00001). In the intervention schools, 3160 (80.1%) of 3943 children that completed the test after one year achieved a predetermined passing score (≥13 of 24 correct answers) compared with 1464 (51.5%) of 2844 children in the control schools (adjusted difference 39.5%, 95% CI 29.9 to 47.5). Conclusion Use of the learning-resources led to a large improvement in the ability of children to assess claims, which was sustained for at least one year.

Download Full-text

Cytokine profile and clinical correlates in HIV-exposed infants with severe (hypoxic) pneumonia

South African Respiratory Journal ◽

10.7196/sarj.2016.v22i1.60 ◽

2016 ◽

Vol 22 (1) ◽

pp. 3 ◽

Cited By ~ 1

Author(s):

Robin Green ◽

A Terclanche ◽

P Becker ◽

P Rheeder ◽

D F Wittenberg ◽

...

Keyword(s):

Severe Pneumonia ◽

Sub Saharan Africa ◽

Control Group ◽

Clinical Correlates ◽

Sub Saharan ◽

Paired Serum ◽

Hiv Exposed ◽

Host Inflammatory Response ◽

Severe Lung Disease ◽

Severe Lung

Introduction. Severe pneumonia in infants who are HIV-infected is a common problem in many parts of the developing world, especially sub-Saharan Africa. What has been missing from previous studies of severe pneumonia in HIV-infected infants, however, is a description of the host inflammatory response and cytokine/chemokine profile that accompanies this disease.Objective. To describe the cytokine profiles associated with severe hypoxic pneumonia in HIV-infected infantsMethods. In a cohort of HIV-infected children diagnosed clinically with severe hypoxic pneumonia, paired serum and sputum cytokines were tested. A control group of HIV-infected children with bronchiectasis contributed matching controls.Results. A total of 100 infants (mean age 2.8 months) with a clinical diagnosis of severe hypoxic pneumonia were included in this study. IP-10 was markedly elevated in both sputum (mean 560.77pg/ml) and serum (mean 9091.14pg/ml), while IP-10 was elevated in serum (mean 39.55 pg/ml), with both these cytokines being significantly higher than in stable children with HIV-related bronchiectasis.Conclusion. This study of HIV-infected infants with severe hypoxic pneumonia suggests that IL-10 and IP-10 are associated with more severe lung disease. However, further investigation of this association is required.

Download Full-text

Feasibility of alcohol screening and brief intervention in primary health care in Kazakhstan: study protocol of a pilot cluster randomised trial

Pilot and Feasibility Studies ◽

10.1186/s40814-019-0547-x ◽

2020 ◽

Vol 6 (1) ◽

Author(s):

Bernd Schulte ◽

Amy O’Donnell ◽

Harald Lahusen ◽

Christina Lindemann ◽

Mariya Prilutskaya ◽

...

Keyword(s):

Health Care ◽

Primary Health Care ◽

Brief Intervention ◽

Randomised Trial ◽

Alcohol Screening ◽

Cluster Randomised Trial ◽

Control Group ◽

Screening And Brief Intervention ◽

Primary Health ◽

Cluster Randomised

Abstract Background Identifying and addressing heavy drinking represents a major public health priority worldwide. Whilst the majority of alcohol screening and brief intervention (ASBI) research has been conducted in western, high-income countries, evidence is growing that ASBI can also impact positively on heavy drinkers in low- and middle-income country populations. This mixed methods study aims to assess the feasibility of conducting a fully randomised controlled trial of the effectiveness of ASBI in primary care in Kazakhstan and explore the feasibility and acceptability of implementing ASBI in this setting from patients’ and physicians’ perspectives. Methods Six primary health care units in the region of Pavlodar will be cluster randomised to either an intervention (WHO manualised 5 min alcohol brief intervention plus alcohol leaflet) or control group (simple feedback plus alcohol leaflet). Primary feasibility measures will be rates of participation at baseline and retention of eligible patients at the 3-month follow-up point. Patient/physician questionnaires and physician focus groups will assess additional dimensions of feasibility, as well as acceptability, according to the RE-AIM framework: Reach (rates of eligible patients screened/received advice); Effectiveness (change in AUDIT-C score); Adoption (rate/representativeness of participating physicians); Implementation (quality of ASBI/barriers and facilitators to delivery); and Maintenance (potential sustainability of intervention). Discussion This is the first trial of the feasibility and acceptability of ASBI in Kazakhstan. As the planning and assessment of implementation determinants is based on the RE-AIM framework, the project outcomes will be relevant for the future development, tailoring and implementation of ASBI in Kazakhstan. Trial registration DRKS, DRKS00015882, Registered 17 December 2018.

Download Full-text

Effect of fertility health awareness strategies on fertility knowledge and childbearing in young married couples (FertStart): study protocol for an effectiveness-implementation hybrid type I multicentre three-arm parallel group open-label randomised clinical trial

BMJ Open ◽

10.1136/bmjopen-2021-051710 ◽

2022 ◽

Vol 12 (1) ◽

pp. e051710

Author(s):

Sze Ling Chan ◽

Julian Thumboo ◽

Jacky Boivin ◽

Seyed Ehsan Saffari ◽

Shanqing Yin ◽

...

Keyword(s):

Semen Analysis ◽

Randomised Trial ◽

Married Couples ◽

Control Group ◽

Type I ◽

Age At First Birth ◽

Fertility Awareness ◽

Hybrid Type ◽

Study Results ◽

Post Randomisation

IntroductionBirth rates have been declining in many advanced societies including Singapore. We designed two interventions with vastly different resource requirements, which include fertility education, personalised fertility information and a behavioural change component targeting modifiable psychological constructs to modify fertility awareness and childbearing intentions. We aim to evaluate the effect of these two interventions on knowledge, attitudes and practice around childbearing compared with a control group among young married couples in Singapore and understand the implementation factors in the setting of an effectiveness-implementation hybrid type 1 three-arm randomised trial.Methods and analysisWe will randomise 1200 young married couples to no intervention (control), Fertility Health Screening group (FHS) or Fertility Awareness Tools (FAT) in a 7:5:5 ratio. Couples in FHS will undergo an anti-Mullerian hormone test and semen analysis, a doctor’s consultation to explain the results and standardised reproductive counselling by a trained nurse. Couples in FAT will watch a standardised video, complete an adapted fertility status awareness (FertiSTAT) tool and receive an educational brochure. The attitudes, fertility knowledge and efforts to achieve pregnancy of all couples will be assessed at baseline and 6 months post-randomisation. Birth statistics will be tracked using administrative records at 2 and 3 years. The primary outcome is the change in the woman’s self-reported intended age at first birth between baseline and 6 months post-randomisation. In addition, implementation outcomes and cost-effectiveness of the two interventions will be assessed.Ethics and disseminationThis study has been reviewed and approved by the Centralized Institutional Review Board of SingHealth (2019/2095). Study results will be reported to the study funder and there are plans to disseminate them in scientific conferences and publications, where authorship will be determined by the International Committee of Medical Journal Editors guidelines.Trial registration numberNCT04647136; ClinicalTrails.gov Identifier.

Download Full-text

Effects of the Informed Health Choices primary school intervention on the ability of children in Uganda to assess the reliability of claims about treatment effects, one-year follow-up: a cluster-randomised trial

10.21203/rs.2.12516/v2 ◽

2019 ◽

Cited By ~ 1

Author(s):

Allen Nsangi ◽

Daniel Semakula ◽

Andrew David Oxman ◽

Astrid Austvoll- Dalghren ◽

Matt Oxman ◽

...

Keyword(s):

Primary School ◽

Primary Schools ◽

Randomised Trial ◽

Multiple Choice ◽

Cluster Randomised Trial ◽

Control Group ◽

Cluster Randomised ◽

Health Choices ◽

The Mean ◽

One Year

Download Full-text

Community-based amoxicillin treatment for fast breathing pneumonia in young infants 7–59 days old: a cluster randomised trial in rural Bangladesh, Ethiopia, India and Malawi

BMJ Global Health ◽

10.1136/bmjgh-2021-006578 ◽

2021 ◽

Vol 6 (8) ◽

pp. e006578

Author(s):

◽

Yasir B Nisar

Keyword(s):

Case Management ◽

Treatment Failure ◽

Pulse Oximetry ◽

Health Facility ◽

Community Level ◽

Secondary Outcome ◽

Control Group ◽

Community Case Management ◽

Young Infants ◽

Cluster Randomised

IntroductionYoung infants 7–59 days old with fast breathing pneumonia presented to a primary level health facility receive a 7-day course of amoxicillin as per the WHO guideline. However, community-level health workers (CLHW) are not allowed to treat these infants. This trial evaluated the community level treatment of non-hypoxaemic young infants with fast breathing pneumonia by CLHWs.MethodsThis cluster-randomised, open-label, non-inferiority trial was conducted in rural areas of Bangladesh, Ethiopia, India and Malawi. We randomly allocated clusters (first-level health facility) 1:1, stratified by the population size, to an intervention group (enhanced community case management) or control group (standard community case management). Infants aged 7–59 days with a respiratory rate of ≥60 breaths/min and oxygen saturation (SpO2) ≥90% were enrolled. In the intervention clusters, these infants were treated with a 7-day course of oral amoxicillin (according to WHO weight bands) and were regularly followed up by CLHWs. In the control clusters, CLHWs continued the standard management (assess and refer after pre-referral antibiotic dose) and followed up according to the national programme guideline. The primary outcome of treatment failure was assessed in both groups by independent outcome assessors on days 6 and 14 after enrolment. Secondary outcomes (accuracy and impact of pulse oximetry) were also assessed.ResultsBetween September 2016 and December 2018, we enrolled 2334 infants (1168 in intervention and 1166 in control clusters) from 208 clusters (104 intervention and 104 control). Of 2334, 22 infants with fast breathing were excluded from analysis, leaving 2312 (1155 in intervention clusters and 1157 in control clusters) for intention-to-treat analysis. The proportion of treatment failure was 5.4% (63/1155) in intervention and 6.3% (73/1157) in the control clusters, including two deaths (0.2%) in each group. The adjusted risk difference for treatment failure between the two groups was −1.0% (95% CI −3.0% to 1.1%). The secondary outcome showed that CLHWs in the intervention clusters performed all recommended steps of pulse oximetry assessment in 94% (1050/1115) of enrolled patients.ConclusionsThe 7-day amoxicillin treatment for 7–59 days old non-hypoxaemic infants with fast breathing pneumonia by CLHWs was non-inferior to the currently recommended referral strategy.Trial registration numbersCTRI/2017/02/007761 and ACTRN12617000857303.

Download Full-text

Effect of early cryoprecipitate transfusion versus standard care in women who develop severe postpartum haemorrhage (ACROBAT) in the UK: a protocol for a pilot cluster randomised trial

BMJ Open ◽

10.1136/bmjopen-2019-036416 ◽

2020 ◽

Vol 10 (6) ◽

pp. e036416

Author(s):

Laura Green ◽

Jahnavi Daru ◽

Julie Dodds ◽

Francisco Jose Gonzalez Carreras ◽

Doris Lanz ◽

...

Keyword(s):

Pilot Study ◽

Postpartum Haemorrhage ◽

Randomised Trial ◽

Intervention Group ◽

Qualitative Evaluation ◽

Primary Objective ◽

Cluster Randomised Trial ◽

Control Group ◽

Advisory Group ◽

Cluster Randomised

IntroductionThe incidence of severe postpartum haemorrhage (PPH) that requires blood transfusion is on the increase. Fibrinogen levels have been shown to drop early and significantly during PPH, which is associated with worse outcomes. Early fibrinogen replacement could potentially improve outcomes. No studies have investigated the clinical impact of early cryoprecipitate transfusion in PPH. Prior to performing a full-scale trial, a pilot study is needed to determine feasibility of the intervention and recruitment.MethodsACROBAT is a cluster-randomised pilot study with a qualitative evaluation. Four large London maternity units are randomised to either the intervention or control group. The intervention group will adapt their major obstetric haemorrhage procedures to administer cryoprecipitate early for primary PPH. The control group will retain their standard of care.We include women at >24 weeks gestation who are actively bleeding within 24 hours of delivery and for whom transfusion of red blood cells (RBCs) has been started. We exclude women who decline blood transfusions in advance or have inherited Factor XIII or fibrinogen deficiency. Due to the emergency nature of the intervention, informed consent for administering the intervention is waived.The primary objective is to assess the feasibility of administering cryoprecipitate within 90 min of RBC request, as compared with standard treatment where cryoprecipitate is given later or not at all. Secondary objectives include the feasibility of recruitment and data collection, reasons for and barriers to consent, preliminary maternal clinical outcomes, identification of the optimal infrastructure pathways for study delivery, and acceptability of the intervention and outcomes.Ethics and disseminationThe trial has approvals from the London—Brighton & Sussex Research Ethics Committee (ref. 18/LO/2062), the Confidentiality Advisory Group (ref. 18/CAG/0199) and Health Research Authority (IRAS number 237959). Data analysis and publication of manuscripts will start in Q3 2020.Trial registration numberISRCTN12146519.

Download Full-text

WHISPER or SHOUT study: protocol of a cluster-randomised controlled trial assessing mHealth sexual reproductive health and nutrition interventions among female sex workers in Mombasa, Kenya

BMJ Open ◽

10.1136/bmjopen-2017-017388 ◽

2017 ◽

Vol 7 (8) ◽

pp. e017388 ◽

Cited By ~ 7

Author(s):

Frances H Ampt ◽

Collins Mudogo ◽

Peter Gichangi ◽

Megan S C Lim ◽

Griffins Manguro ◽

...

Keyword(s):

Reproductive Health ◽

Mobile Phone ◽

Sex Work ◽

Sex Workers ◽

Female Sex Workers ◽

Randomised Trial ◽

The Other ◽

Control Group ◽

Female Sex ◽

Cluster Randomised

IntroductionNew interventions are required to reduce unintended pregnancies among female sex workers (FSWs) in low- and middle-income countries and to improve their nutritional health. Given sex workers’ high mobile phone usage, repeated exposure to short messaging service (SMS) messages could address individual and interpersonal barriers to contraceptive uptake and better nutrition.MethodsIn this two-arm cluster randomised trial, each arm constitutes an equal-attention control group for the other. SMS messages were developed systematically, participatory and theory-driven and cover either sexual and reproductive health (WHISPER) or nutrition (SHOUT). Messages are sent to participants 2–3 times/week for 12 months and include fact-based and motivational content as well as role model stories. Participants can send reply texts to obtain additional information. Sex work venues (clusters) in Mombasa, Kenya, were randomly sampled with a probability proportionate to venue size. Up to 10 women were recruited from each venue to enrol 860 women. FSWs aged 16–35 years, who owned a mobile phone and were not pregnant at enrolment were eligible. Structured questionnaires, pregnancy tests, HIV and syphilis rapid tests and full blood counts were performed at enrolment, with subsequent visits at 6 and 12 months.AnalysisThe primary outcomes of WHISPER and SHOUT are unintended pregnancy incidence and prevalence of anaemia at 12 months, respectively. Each will be compared between study groups using discrete-time survival analysis.Potential limitationsContamination may occur if participants discuss their intervention with those in the other trial arm. This is mitigated by cluster recruitment and only sampling a small proportion of sex work venues from the sampling frame.ConclusionsThe design allows for the simultaneous testing of two independent mHealth interventions for which messaging frequency and study procedures are identical. This trial may guide future mHealth initiatives and provide methodological insights into use of reciprocal control groups.Trial registration numberACTRN12616000852459; Pre-results.

Download Full-text

Oxygen systems and quality of care for children with pneumonia, malaria and diarrhoea: Analysis of a stepped-wedge trial in Nigeria

PLoS ONE ◽

10.1371/journal.pone.0254229 ◽

2021 ◽

Vol 16 (7) ◽

pp. e0254229

Author(s):

Hamish R. Graham ◽

Jaclyn Maher ◽

Ayobami A. Bakare ◽

Cattram D. Nguyen ◽

Adejumoke I. Ayede ◽

...

Keyword(s):

Quality Of Care ◽

Pulse Oximetry ◽

Severe Malaria ◽

Randomised Trial ◽

Severe Pneumonia ◽

World Health ◽

Stepped Wedge ◽

Severe Dehydration ◽

Oxygen System

Objectives To evaluate the effect of improved hospital oxygen systems on quality of care (QOC) for children with severe pneumonia, severe malaria, and diarrhoea with severe dehydration. Design Stepped-wedge cluster randomised trial (unblinded), randomised at hospital-level. Setting 12 hospitals in south-west Nigeria. Participants 7,141 children (aged 28 days to 14 years) admitted with severe pneumonia, severe malaria or diarrhoea with severe dehydration between January 2014 and October 2017. Interventions Phase 1 (pulse oximetry) introduced pulse oximetry for all admitted children. Phase 2 (full oxygen system) (i) standardised oxygen equipment package, (ii) clinical education and support, (iii) technical training and support, and (iv) infrastructure and systems support. Outcome measures We used quantitative QOC scores evaluating assessment, diagnosis, treatment, and monitoring practices against World Health Organization and Nigerian standards. We evaluated mean differences in QOC scores between study periods (baseline, oximetry, full oxygen system), using mixed-effects linear regression. Results 7,141 eligible participants; 6,893 (96.5%) had adequate data for analysis. Mean paediatric QOC score (maximum 6) increased from 1.64 to 3.00 (adjusted mean difference 1.39; 95% CI 1.08–1.69, p<0.001) for severe pneumonia and 2.81 to 4.04 (aMD 1.53; 95% CI 1.23–1.83, p<0.001) for severe malaria, comparing the full intervention to baseline, but did not change for diarrhoea with severe dehydration (aMD -0.12; 95% CI -0.46–0.23, p = 0.501). After excluding practices directly related to pulse oximetry and oxygen, we found aMD 0.23 for severe pneumonia (95% CI -0.02–0.48, p = 0.072) and 0.65 for severe malaria (95% CI 0.41–0.89, p<0.001) comparing full intervention to baseline. Sub-analysis showed some improvements (and no deterioration) in care processes not directly related to oxygen or pulse oximetry. Conclusion Improvements in hospital oxygen systems were associated with higher QOC scores, attributable to better use of pulse oximetry and oxygen as well as broader improvements in clinical care, with no negative distortions in care practices. Trial registration ACTRN12617000341325

Download Full-text