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Table 1 Outcomes and data collection methods for evaluation of the Saving Babies’ Lives programme intervention in Preah Vihear province, Cambodia

From: Saving babies’ lives (SBL) – a programme to reduce neonatal mortality in rural Cambodia: study protocol for a stepped-wedge cluster-randomised trial

Objectives Expected Outcomes Measures Methods of data collection Time point
Primary objective
 Design, implementation and assessment of an effective programme to reduce neonatal mortality An effective programme blueprint Replication of the SBL programme Government records
Research records
End
Secondary objective
 Reduce neonatal mortality Reduction in neonatal mortality Neonatal mortality rate Surveillance Continuous
Tertiary objectives
 Describe neonatal epidemiology over a five-year period Description of neonatal epidemiology Characteristics of all neonates born: gestation, birth weight, gender, birth location, season of birth Surveillance Continuous
Characteristics of all neonates that die: Causes of stillbirths and neonatal deaths, contributing factors to stillbirths and neonatal deaths, location, timing, season Surveillance,
Verbal autopsy,
Social autopsy
Continuous
 Improve community-based and primary care for all neonates Effective neonatal care provided by CHWs CHW engagement: PLA attendance rate and frequency, awareness and motivation regarding neonatal healthcare, interaction between group and facilitator PLA records Continuous
CHW empowerment: knowledge, attitudes and practice regarding neonatal care, number of interventions implemented by CHWs KAP survey
PLA records
Annual
Continuous
Effective neonatal care provided by primary care facilities Facility health outcomes: facility neonatal mortality Surveillance Continuous
Facility capacity to provide neonatal care: equipped and staffed facilities, skilled healthcare workers: knowledge, attitudes and practice regarding neonatal care KAPES survey Annual
Effective linkage between health system levels Neonatal healthcare linkage: referral patterns, home delivery rate, care-seeking patterns Facility records, Surveillance,
Social autopsy
Continuous
 Develop an effective neonatal programme Improved neonatal health outcomes Perinatal mortality (stillbirth rate + death within first 7 days of live birth) Surveillance Continuous
First day mortality (death within first 24 h of live birth) Surveillance Continuous
Change in patterns of neonatal death: causes of death (cause-specific mortality fraction), location, timing, season Verbal autopsy Continuous
Feasible and acceptable programme CHW perceptions about programme: satisfaction, facilitators and barriers, successes and challenges Feedback surveys, FGDs & SSIs End
Healthcare worker perceptions about programme: satisfaction, facilitators and barriers, successes and challenges Feedback surveys, FGDs & SSIs End
Policy-maker and implementer perceptions about programme: satisfaction, facilitators and barriers, successes and challenges Feedback surveys, FGDs & SSIs End
Influence or incorporation of programme components into Ministry of Health policy or strategy Government records End
 Calculate cost-effectiveness of the intervention Cost-effective programme Cost-effectiveness of the intervention compared to normal standard of care: disability-adjusted life years, quality-adjusted life years Research administrative records End
  1. SBL Saving Babies’ Lives, CHW Community health worker, PLA Participatory learning and action, KAP Knowledge, attitudes, practice, FGDs Focus group discussions, SSIs Semi-structured interviews, KAPES Knowledge, attitudes, practice, equipment, staffing