At every pivotal stage in my career, Atul Gawande’s works were instrumental in shaping my perceptions and growth. As a mere medical student making my first foray into the world of clinical rotations, his book ‘Better’ showed me the softer side of medicine, and the positive attitudes we must inculcate in the face of strife for ‘wellness’. Through my clinical years, his book ‘Complications’ demonstrated how uncertainty is a crucial component of the care we provide, and embracing it while maintaining a clear sense of expecting the unexpected makes for a well-prepared physician. Prior to residency, ‘The Checklist Manifesto’ laid down the foundations of the field of ‘Quality Improvement’- and how ‘simple’ tweaks, with minimal efforts, in our systems and behaviors, can have huge impacts on patient outcomes.
But those ‘simple’ tweaks are not always ‘simple’ and neither always just ‘tweaks’, especially in a system where supply chains are fragmented, or non-existent, and each step for a patient or provider in accessing quality healthcare is a challenge. There is immense potential for building on core evidence-based steps that matter, to build and strengthen systems gradually, to reap greater rewards over time.
One does not often hear of randomized controlled trials for evidence-based policies in global health, particularly targeting concerns in Lower-Middle Income Countries, especially at large scales. However, Dr. Gawande and his team have published paradigm-altering work in the NEJM that attempts to apply this rigorous approach (1.).
The BetterBirth Study
The BetterBirth program was an 8-month coaching-based implementation of the Safe Childbirth Checklist – a 28-point, quality-improvement tool developed by the World Health Organization (WHO). The elegantly designed study was a matched-pair, cluster-randomized, controlled trial, that aimed to determine whether the BetterBirth program, when deployed in primary care health centers in the state of Uttar Pradesh, India, promoted systematic adherence to practices that have been associated with improved childbirth outcomes. They adjudged improved childbirth outcomes as improvement in the composite primary outcome consisting of perinatal death, maternal death, or maternal severe complications within 7 days after delivery.
Before delving into the details of the study, first a few words on Uttar Pradesh.
Context: the state of Uttar Pradesh, India
For some context, Uttar Pradesh (U.P.), India (map given below), is a state characterized by frenetic cities bustling with life, mosaiced with vast fertile tracts of agricultural land supplied by the Ganges. UP may be the size of France, but holds one-fifth of India’s billion-plus population.
The healthcare system, both public and private is known to be understaffed and under resourced(2.). Even if individual healthcare providers wish to provide quality care, a ‘system’ with lack of resources – from sanitary supplies to medications – results in major hurdles. This reflects in some of the poorest health statistics in the country. A maternal mortality ratio of ~260 per 100,000 live births, (for comparison, in Japan it is 4 and in USA it is 12.7 /100,000 live births). Whether this outcome is the result of poor local practices, population dynamics or results of poor implementation of policies, one can only speculate, but the study aimed to improve processes at the local primary health referral level.
The Engage-Launch-Support model of coaching was used for the deployment of the BetterBirth program after pilot testing it in non-trial facilities. The study was gargantuan in magnitude; comparisons were done across 60 pairs of facilities, covering 24 districts of Uttar Pradesh, testing the effects on 157,689 enrolled women.
Of the 157,689 (97.9%) women enrolled, 7-day outcomes were determined for 157,145 (99.7%) mother–newborn dyads. Of the 4888 observed births, birth attendants’ mean practice adherence were 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).
However, there was no significant difference between the trial groups either in the composite primary outcome i.e. mortality (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.
Despite process improvement, No difference in Mortality…
A word of caution: The tagline above may be a simplistic look at the results. However, the items on the checklist have proven evidence showing effectiveness in improving maternal and child health outcomes in the perinatal period; for instance, we know handwashing prevents infections and saves lives (Let’s not have Semmelweis turn in his grave).
The study found that Birth attendants performed the majority of specific practices, such as blood-pressure and temperature assessment, proper hand hygiene, and early newborn care, at significantly higher rates in the intervention group than in the control group. Processes did improve at local settings, behaviors and practices, albeit for the short term did improve as well, however, we need to explore what needs to be added for shifting important patient outcomes.
So, the larger context of issues in the supply chain of healthcare, even outside the hospital setting may need to be taken into account; the population being served and their access to timely effective interventions, their baseline health staus and more, may need bolstering, before we’ll start to see downstream clinically significant outcomes like mortality benefits.
What was the baseline health of these women? How much of a dent in the numbers can facility-based practice improvements lead to in a country with an overwhelming, almost universal, prevalence of anemia and malnutrition in adolescent girls? Were these women able to access and follow up with quality antenatal and postnatal care beyond the ambit of the BetterBirth study? Were these women able to access skilled healthcare in a timely manner? If women needed to be referred to higher levels of care for complications, were they able to transported to these facilities in a timely manner? Persistent gaps in technical skills, management of complications, the quality and quantity of supplies and medicines, access to supportive management, and systems-level accountability — mostly unmeasured — could also have had a substantial effect on the ability to improve health outcomes.
Another question that needs to be asked is whether there was actually a large enough change in the practices, to create a statistically meaningful impact on the composite outcome measure. There are clearly multiple systems issues that cannot be addressed by the BetterBirth approach, most of which have been described in the discussion section of the paper. Dr. Madhukar Pai, a leading tuberculosis and global health researcher, enunciates in this post (3), a word of caution against using and interpreting surrogate endpoints for meaningful outcomes, especially in global health, and with respect to this study. Further, one cannot help but wonder, whether the sub-group that was chosen to study the adherence to the coached habits, was actually representative of all the centers in the study, and to what extent the practices deviated from the coached norms when the observations were not made (Hawthorne effect?).
Overall, birth attendants in non-intervention facilities performed approximately 40% of measured essential practices in a typical birth, such as appropriate hand hygiene, and given the lack of benefit in mortality, may in a way be interpreted to be a good sign, in that the health centers have not completely failed its people. Further issues which are beyond the healthcare providers’ control could modulate these outcomes. This may result in a plea to policy makers to ensure provisions for effective healthcare delivery systems.
A facility-based quality improvement checklist was associated with process improvement in Safe deliveries, though did not alter maternal, or neonatal mortality, Positives we take from this – studies in challenging lower-resourced settings are possible. Further, process and behavioral changes are also feasible. However, if we are to address a broader range of factors impacting patient centered outcomes, continued efforts are needed to identify the rate limiting steps in the healthcare delivery supply chain in low-resource care.
1. Semrau KEA, Hirschhorn LR, Marx Delaney M, Singh VP, Saurastri R, Sharma N, Tuller DE, Firestone R, Lipsitz S, Dhingra-Kumar N, Kodkany BS, Kumar V, Gawande AA; BetterBirth Trial Group. Outcomes of a Coaching-Based WHO Safe Childbirth Checklist Program in India. N Engl J Med. 2017 Dec 14;377(24):2313-2324. doi: 10.1056/NEJMoa1701075. PubMed PMID: 29236628
2. As Population Rises, UP’s Healthcare System Collapses. Accessed from: http://www.indiaspend.com/cover-story/as-population-rises-ups-healthcare-system-collapses-92188