Outcomes of a Coaching-Based WHO Safe Childbirth Checklist Program in India.

BACKGROUND: The prevalence of facility-based childbirth in low-resource settings has increased dramatically during the past two decades, yet gaps in the quality of care persist and mortality remains high. The World Health Organization (WHO) Safe Childbirth Checklist, a quality-improvement tool, promotes systematic adherence to practices that have been associated with improved childbirth outcomes. METHODS: We conducted a matched-pair, cluster-randomized, controlled trial in 60 pairs of facilities across 24 districts of Uttar Pradesh, India, testing the effect of the BetterBirth program, an 8-month coaching-based implementation of the Safe Childbirth Checklist, on a composite outcome of perinatal death, maternal death, or maternal severe complications within 7 days after delivery. Outcomes - assessed 8 to 42 days after delivery - were compared between the intervention group and the control group with adjustment for clustering and matching. We also compared birth attendants' adherence to 18 essential birth practices in 15 matched pairs of facilities at 2 and 12 months after the initiation of the intervention. RESULTS: Of 161,107 eligible women, we enrolled 157,689 (97.9%) and determined 7-day outcomes for 157,145 (99.7%) mother-newborn dyads. Among 4888 observed births, birth attendants' mean practice adherence was significantly higher in the intervention group than in the control group (72.8% vs. 41.7% at 2 months; 61.7% vs. 43.9% at 12 months; P<0.001 for both comparisons). However, there was no significant difference between the trial groups either in the composite primary outcome (15.1% in the intervention group and 15.3% in the control group; relative risk, 0.99; 95% confidence interval, 0.83 to 1.18; P=0.90) or in secondary maternal or perinatal adverse outcomes. CONCLUSIONS: Birth attendants' adherence to essential birth practices was higher in facilities that used the coaching-based WHO Safe Childbirth Checklist program than in those that did not, but maternal and perinatal mortality and maternal morbidity did not differ significantly between the two groups. (Funded by the Bill and Melinda Gates Foundation; Clinical Trials number, NCT02148952 .).

Agreeing on global research priorities for medication safety: an international prioritisation exercise.

OBJECTIVES: Medication errors continue to contribute substantially to global morbidity and mortality. In the context of the recent launch of the World Health Organization's (WHO) Third Global Patient Safety Challenge: Medication Without Harm, we sought to establish agreement on research priorities for medication safety. METHODS: We undertook a consensus prioritisation exercise using an approach developed by the Child Health and Nutrition Research Initiative. Based on a combination of productivity and citations, we identified leading researchers in patient and medication safety and invited them to participate. We also extended the invitation to a further pool of experts from the WHO Global Patient Safety Network. All experts independently generated research ideas, which they then independently scored based on the criteria of: answerability, effectiveness, innovativeness, implementation, burden reduction and equity. An overall Research Priority Score and Average Expert Agreement were calculated for each research question. FINDINGS: 131 experts submitted 333 research ideas, and 42 experts then scored the proposed research questions. The top prioritised research areas were: (1) deploying and scaling technology to enhance medication safety; (2) developing guidelines and standard operating procedures for high-risk patients, medications and contexts; (3) score-based approaches to predicting high-risk patients and situations; (4) interventions to increase patient medication literacy; (5) focused training courses for health professionals; and (6) universally applicable pictograms to avoid medication-related harm. Whilst there was a focus on promoting patient education and involvement across resource settings, priorities identified in high-resource settings centred on the optimisation of existing systems through technology. In low- and middle-resource settings, priorities focused on identifying systemic issues contributing to high-risk situations. CONCLUSIONS: WHO now plans to work with global, regional and national research funding agencies to catalyse the investment needed to enable teams to pursue these research priorities in medication safety across high-, middle- and low-resource country settings.

What stage are low-income and middle-income countries (LMICs) at with patient safety curriculum implementation and what are the barriers to implementation? A two-stage cross-sectional study.

OBJECTIVES: The improvement of safety in healthcare worldwide depends in part on the knowledge, skills and attitudes of staff providing care. Greater patient safety content in health professional education and training programmes has been advocated internationally. While WHO Patient Safety Curriculum Guides (for Medical Schools and Multi-Professional Curricula) have been widely disseminated in low-income and middle-income countries (LMICs) over the last several years, little is known about patient safety curriculum implementation beyond high-income countries. The present study examines patient safety curriculum implementation in LMICs. METHODS: Two cross-sectional surveys were carried out. First, 88 technical officers in Ministries of Health and WHO country offices were surveyed to identify the pattern of patient safety curricula at country level. A second survey followed that gathered information from 71 people in a position to provide institution-level perspectives on patient safety curriculum implementation. RESULTS: The majority, 69% (30/44), of the countries were either considering whether to implement a patient safety curriculum or actively planning, rather than actually implementing, or embedding one. Most organisations recognised the need for patient safety education and training and felt a safety curriculum was compatible with the values of their organisation; however, important faculty-level barriers to patient safety curriculum implementation were identified. Key structural markers, such as dedicated financial resources and relevant assessment tools to evaluate trainees' patient safety knowledge and skills, were in place in fewer than half of organisations studied. CONCLUSIONS: Greater attention to patient safety curriculum implementation is needed. The barriers to patient safety curriculum implementation we identified in LMICs are not unique to these regions. We propose a framework to act as a global standard for patient safety curriculum implementation. Educating leaders through the system in order to embed patient safety culture in education and clinical settings is a critical first step.

A Patient Safety Information Model for Interoperability.

Current systems that target Patient Safety (PS) like mandatory reporting systems and specific vigilance reporting systems share the same information types but are not interoperable. Ten years ago, WHO embarked on an international project to standardize quality management information systems for PS. The goal is to support interoperability between different systems in a country and to expand international sharing of data on quality and safety management particularly for less developed countries. Two approaches have been used: (i) a bottom-up one starting with existing national PS reporting and international or national vigilance systems, and (ii) a top-down approach that uses the Patient Safety Categorial Structure (PS-CAST) and the Basic Formal Ontology (BFO) upper level ontology versions 1 and 2. The output is currently tested as an integrated information system for quality and PS management in four WHO member states.

Effectiveness of the WHO Safe Childbirth Checklist program in reducing severe maternal, fetal, and newborn harm in Uttar Pradesh, India: study protocol for a matched-pair, cluster-randomized controlled trial.

BACKGROUND: Effective, scalable strategies to improve maternal, fetal, and newborn health and reduce preventable morbidity and mortality are urgently needed in low- and middle-income countries. Building on the successes of previous checklist-based programs, the World Health Organization (WHO) and partners led the development of the Safe Childbirth Checklist (SCC), a 28-item list of evidence-based practices linked with improved maternal and newborn outcomes. Pilot-testing of the Checklist in Southern India demonstrated dramatic improvements in adherence by health workers to essential childbirth-related practices (EBPs). The BetterBirth Trial seeks to measure the effectiveness of SCC impact on EBPs, deaths, and complications at a larger scale. METHODS/DESIGN: This matched-pair, cluster-randomized controlled, adaptive trial will be conducted in 120 facilities across 24 districts in Uttar Pradesh, India. Study sites, identified according to predefined eligibility criteria, were matched by measured covariates before randomization. The intervention, the SCC embedded in a quality improvement program, consists of leadership engagement, a 2-day educational launch of the SCC, and support through placement of a trained peer "coach" to provide supportive supervision and real-time data feedback over an 8-month period with decreasing intensity. A facility-based childbirth quality coordinator is trained and supported to drive sustained behavior change after the BetterBirth team leaves the facility. Study participants are birth attendants and women and their newborns who present to the study facilities for childbirth at 60 intervention and 60 control sites. The primary outcome is a composite measure including maternal death, maternal severe morbidity, stillbirth, and newborn death, occurring within 7 days after birth. The sample size (n = 171,964) was calculated to detect a 15% reduction in the primary outcome. Adherence by health workers to EBPs will be measured in a subset of births (n = 6000). The trial will be conducted in close collaboration with key partners including the Governments of India and Uttar Pradesh, the World Health Organization, an expert Scientific Advisory Committee, an experienced local implementing organization (Population Services International, PSI), and frontline facility leaders and workers. DISCUSSION: If effective, the WHO Safe Childbirth Checklist program could be a powerful health facility-strengthening intervention to improve quality of care and reduce preventable harm to women and newborns, with millions of potential beneficiaries. TRIAL REGISTRATION: BetterBirth Study Protocol dated: 13 February 2014; ClinicalTrials.gov: NCT02148952 ; Universal Trial Number: U1111-1131-5647.

Progress in global blood safety for HIV.

OBJECTIVE: To assess progress toward ensuring a globally safe blood supply. DESIGN AND METHODS: We examined 2 global databases for blood safety: (1) that of the United Nations General Assembly Special Session on HIV/AIDS (UNGASS) blood safety indicator; and (2) that of the Global Database on Blood Safety (GDBS), a database developed by the World Health Organization. The UNGASS data were collected through the Ministry of Health based on the GDBS data, followed by a reconciliation and cross-checking of the data by World Health Organization and United Nations Programme on AIDS (UNAIDS). RESULTS: The proportion of United Nations member countries reporting UNGASS data for blood safety is among the highest of all UNGASS indicators: 147 of 192 United Nations Member States participated in UNGASS reporting in 2008 and 125 of them (85%) submitted data on blood safety. Ninety-one of the 125 countries (73%) reported that 100% of collected blood units were screened in a quality assured manner, but 34 countries did not screen all collected blood units in accordance with minimum quality standards. GDBS data showed that 80.7 million blood units were collected globally in 167 countries during 2004-2005, of which 77.3 million were tested for HIV and at least 0.6 million of the remaining 3.4 million donations went untested. CONCLUSIONS: Progress has been made toward eliminating blood transfusion as a significant cause of HIV infection globally. Screening all donated blood for HIV in accordance with minimum quality standards remains vital, however, as health care systems should, at a minimum, do no harm. This goal is achievable and would assist in reaching Millennium Development Goals by 2015.