It was supposed to be a breakthrough moment in global health.
Atul Gawande, the physician and writer, was applying a simple tool he championed — the checklist — to improve birth outcomes in a rural part of India with some of the world’s highest infant mortality rates.
But his closely watched study, the BetterBirth Trial, has produced a disappointing result: Despite increased adherence to best practices, outcomes for babies and mothers did not improve with the use of a checklist and coaching on its implementation, according to data published Wednesday in the New England Journal of Medicine.
“The improvement in quality was part of the answer, but it was not enough,” Gawande said. “We need to understand what more needs to be added to get to the endpoint everyone wants.”
The idea of the checklist is to get caregivers to consistently follow best practices in medicine, rooting out memory lapses and sloppiness that can harm patients. Gawande, author of a best-selling book titled “The Checklist Manifesto,” has posited in his research and writings that its use in an array of settings could dramatically improve quality and save lives.
Its failure to accomplish that latter goal for mothers and babies in India does not necessarily mean that the checklist is faulty, or that it cannot ultimately help patients. But it does indicate that the solution to this particular problem might require more than a checklist alone.
Best practices run into real-world problems
The trial, funded by the Bill and Melinda Gates Foundation, was carried out in Uttar Pradesh, India’s most populous state. It has more than 200 million people and an infant mortality rate of 47 per 1,000 births, compared to about 6 per 1,000 births in the United States.
The study applied a list of best practices, such as handwashing and blood pressure monitoring, to reduce deaths and complications — and make headway in addressing one of the world’s most vexing public health problems. Experts said its failure to improve outcomes underscores both the complexity of the problem and the need for a more comprehensive approach that may extend beyond the walls of the hospital.
“The results are really disappointing because they were borne of such a place of hope and because they were based on a lot of strong evidence,” said Katy Kozhimannil, a rural health researcher at the University of Minnesota who was not involved in the trial. “Sometimes when you put evidence-based practices into the world, the world is stronger than those practices.”
Gawande and his colleagues at Ariadne Labs in Boston developed the checklist in consultation the World Health Organization, which is using it to improve obstetric care in dozens of countries across the world. It is meant to increase adherence to 28 essential practices that have been shown to prevent the biggest killers of mothers and babies in active labor and immediately after birth.
Though the checklist has produced positive results in some parts of the world, the BetterBirth Trial was the largest and most rigorous effort yet to test its effectiveness. The randomized controlled trial involved more than 300,000 mothers and newborns who received care between 2014 and 2016. It compared outcomes in 60 facilities that received an eight-month coaching program on the checklist with those that did not receive the intervention.
It turned out that Gawande’s hypothesis — that a checklist would improve adherence to best practices and reduce complications and deaths — was half right. The trial did result in a significant increase in the use of best practices: After two months of coaching, birth attendants at the intervention sites completed 73 percent of the items on the checklist, compared to 42 percent in the control group.
In several key areas, the gap was even larger. Administration of oxytocin, used to prevent maternal hemorrhage, was 80 percent in the intervention sites, versus 21 percent in control facilities. On maternal blood pressure monitoring, the split was 68 percent to just 7 percent. Initiation of breastfeeding was 70 percent to 4 percent.
“That itself was a substantial accomplishment,” said Gawande, “because it hadn’t been demonstrated in these very low-income environments, at this kind of scale, that you could generate such substantial improvements in the quality of delivery.”
The search for an explanation
But despite adherence to the key practices, the intervention sites did not reduce stillbirths or seven-day death rates for mothers and babies.
Gawande said multiple factors might explain why the results fell short of expectations.
Health centers in Uttar Pradesh, he said, are a far cry from hospitals in the United States. They are cramped and lack basics such as running water and clean towels. They cannot provide blood transfusions and there are no surgical facilities for performing caesarean sections. In addition, most births are attended by practitioners with nurse-level training, not doctors or midwives.
Another possible explanation is that the checklist intervention was not long enough. The coaching tapered off after eight months, and follow-up checks revealed that, by one year, hospitals’ adherence to the checklist items had slipped from 73 percent to 62 percent, possibly eroding quality gains.
Gawande said his work implementing a different checklist, to improve surgical outcomes, showed that multiple years of coaching, combined with mandatory participation enforced by hospital leaders, produced better results. In Scotland, for example, the surgical checklist program resulted in a 26 percent reduction in deaths.
In India and elsewhere, Gawande said, reducing mother and infant deaths might require more systemic buy-in, to ensure that the effort is prioritized at all levels, from government overseers to hospital leaders and caregivers.
“In the next places rolling it out, they are testing if you combine it with skills training or push more supplies to the front line — and do that as a commitment of the health system — will that drive better results?” Gawande said. “I think it could.”
Meanwhile, in Uttar Pradesh, caregivers fight through the daily challenges of ensuring safety for moms and babies. In some clinics, a staffer must fetch water from a local well to make sure birth attendants can wash their hands before every delivery. Staff sometimes use diluted bleach to scrub and re-use their gloves, a practice that cannot get them fully clean, or sterile. Some facilities struggle to maintain a supply of blood pressure cuffs to make sure mothers could be properly monitored during labor.
Each problem erects another small barrier, taking more time and requiring more effort to help mothers and babies who, as a consequence of their location in the world, face a much higher probability of death.
A reason for hope
Even if the trial did not improve this region’s odds, Gawande said, he glimpsed moments when it helped them overcome.
He was visiting a clinic in the region when a woman in her 20s arrived for her third birth. Her water broke almost immediately upon entering, and active labor quickly followed. She was hustled to the delivery room and caregivers began working through their checks — they applied the blood pressure cuffs and took her temperature; they checked for the fetal heart rate.
The baby, a girl, came swiftly and did not look right. She wasn’t breathing.
It is a problem that occurs in 10 percent of births and is a leading cause of newborn death. The caregivers went to their equipment tray and grabbed a clean towel. They dried the baby and began to jostle her, to try to stimulate breathing.
No response. The baby was limp and blue.
One of the attendants grabbed a nasal suction. She put the tubing in her mouth and began sucking out the baby’s nasal passages. A green glob of meconium emerged from the baby’s airway.
Suddenly a breath came, and then another. By following the checklist, and the thought process and coaching that came with it, the caregivers had succeeded.
“Within a minute the baby was pink again and screaming and crying,” Gawande said. “And then everybody was breathing again.”