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Friday, September 16, 2011
MassGeneral Hospital for Children neonatologist Jonathan M. Spector, MD, MPH, is the co-principal investigator of the BetterBirth trial, a study to evaluate the effectiveness of the World Health Organization (WHO) Safe Childbirth Checklist program. The checklist program offers action items for health care workers from the time an expectant mother is admitted to the hospital to the time she and her newborn are discharged home.
Jonathan M. Spector, MD, MPH
The clinical trial to test the checklist program is based at the Harvard School of Public Health, which was awarded a $14.1 million, four-year grant from the Bill & Melinda Gates Foundation to conduct the study. The study will test the checklist program in 120 hospitals in India over the next several years. Dr. Spector is co-leading the study with Atul Gawande, MD, a surgeon at Brigham and Women’s Hospital who led the development, testing and distribution of the Surgical Safety Checklist.
Dr. Spector answers questions about the Safe Childbirth Checklist program here.
Q: What is the WHO Safe Childbirth Checklist program?
A: The WHO Safe Childbirth Checklist program is a checklist-based childbirth safety program developed to catalyze a safer birthing experience for mothers and babies in resource-poor countries. The program has been ongoing for just shy of three years, and originated from the relatively recent appreciation of the potential benefits afforded by checklist programs in healthcare.
Q: Where did the idea for a birth checklist originate?
A: As Atul [Gawande] has noted, medicine has now evolved to the point where it can be quite complex at any given moment for any one individual or team to successfully and consistently complete each and every essential task required to assure delivery of the safest possible care for patients. We know from experience over the past few years that checklist-based strategies for improving health have proved successful in several disciplines. In particular, we’ve seen that checklist programs can make a measurable difference in health in intensive care medicine and surgery. The WHO Safe Childbirth Checklist program was largely established based on these prior successes.
The team I work with at the Harvard School of Public Health partnered with the WHO to develop and test the Surgical Safety Checklist - a one-page tool used at three discreet points during the course of surgery to ensure that basic tasks are successfully completed. Testing at eight hospitals around the world with more than 7,000 patients found a dramatic reduction in both morbidities and mortality; based on those results, WHO expressed an interest in exploring the extension of this success to other disciplines.
Childbirth very quickly rose to the surface as a potential area of focus because we know that, globally, the burden of disease is enormous and most maternal and newborn deaths are avoidable. There are somewhere in the neighborhood of 350,000 maternal deaths each year, close to 3 million stillbirths (of which more than a million occur intrapartum), and 3.1 million neonatal deaths - most clustered right around the time of birth. The majority of these deaths are preventable and virtually all of them take place in low-income countries. The tragedy here is that with existing knowledge and practice, those deaths are needless. There exists a wide disconnect between what we know should be done and what is actually happening in resource-poor settings around the world. And up until now there’s really been no simple, unifying, widely applicable tool that can help health workers to conduct that better practice. That’s where the checklist-based tool comes in.
I’ll give you an example: One in 10 babies needs help taking the first breath of life. In our labor rooms here at MGHfC I’m on call a few times each month, and on any given night we’ll go to a couple of deliveries where babies need that sort of jumpstart. Sometimes I wonder if the staff here, myself included, take it for granted that we can – in most cases – rescue the babies so relatively easily. Here we benefit from a large team—a doctor, a nurse, a respiratory therapist—and we’ve got all the right supplies. The resuscitation process happens very smoothly because there’s a great system in place and people have been doing it for a very long time. Sadly, that same streamlined process doesn’t happen in many birth centers around the world, and certainly not in those parts of the world where newborn mortality rates are the highest.
Q: What has been done so far to create the Safe Childbirth Checklist?
A: The checklist is a distillation of existing guidelines and evidence. Similar to other checklist programs, there’s nothing new with respect to its evidence-based content, and it’s meant to be locally tailored since there’s really no one-size-fits-all checklist that would be applicable to every birthing site around the world. Often there’s a gap between what people think they’re doing and what actually is being successfully completed. What we found is that using this job aid at the bedside at the moment of care can provide that link, and it can be the catalyst to helping to ensure that essential practices are completed.
The checklist is built to have an impact on mortality and we know globally what the major causes of maternal mortality and newborn mortality are: for women it’s infection, hypertension-related disorders, obstructed and prolonged labor, and bleeding. For babies it’s birth asphyxia (which is the baby’s failure to start breathing at birth), infection and complications of prematurity.
Q: How has the checklist been tested?
A: The WHO Safe Childbirth Checklist has gone through several years of development including early field testing in 17 sites in a number of countries including Kenya, Ghana, India, Tanzania and China. It remains in development. We hope that the BetterBirth trial will provide evidence of whether or not it is effective at improving health outcomes.
Q: What is next step for the checklist?
A: Our next step is to attempt to measure whether the WHO Safe Childbirth Checklist program can reduce maternal, fetal and newborn mortality.
We anticipate enrolling 120 hospitals in northern India over several years in order to be able to demonstrate whether the checklist program can make this difference in survival. Our team at the public health school will be overseeing the trial. We will be working in close collaboration with local partners to finalize the study design, recruit the local facilities, establish key connections with government partners, roll out the checklist program and establish a robust data process system.
If the checklist program is successful – in other words, if it has a meaningful impact on health outcomes and if it’s an impact we can measure – then the trial could provide evidence for the fact that there would be value in rolling it out in high-priority settings worldwide.
We’re happy that our colleagues in the global health arena share our enthusiasm for this approach. It’s got strong promise - the allure of such a simple tool that would be low cost to implement at scale. We think it has great potential and we’re thrilled that others think that it might, as well.
For more information about the BetterBirth trial, contact Jonathan M. Spector, MD, MPH, at firstname.lastname@example.org.
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