Wednesday, April 11, 2012

Ask the Doula: Evidence-Based Care

It's Ask the Doula time again!
Please keep sending in your questions. You can add them as comments below, or send your questions to our Facebook page, or twitter @montrealdoula.

Today I will be looking at the concept of "Evidence-Based Care". What does it mean? How does it work?

Question Number Four

"What is evidenced based maternity care?"

What is the meaning of life? may be an easier question to answer.

First, I will offer you a collection of attempts to define evidence-based maternity care:

"EBM is about tools, not about rules. Good evidence is likely to come from good systematic reviews of good clinical trials. For many reasons too much of the medical literature can be misleading, or is just plain wrong. We must be able to distinguish good evidence from bad, and to have accurate, reliable knowledge readily available and readily accessible for all. The contrast between the individual and the population as a whole - unique biology, choice and circumstance, often dictates what happens, and evidence is but one part of a complex question."

"Evidence-based care is a type of care in which the medical studies are consulted to help you and your caregiver decide the safety and usefulness of all procedures used. With evidence-based care, only procedures that are proven by research to be safe and beneficial are done routinely. Other procedures which are not supported by the medical evidence are weighed carefully, taking your personal circumstances into account. This is called "informed consent". This may seem obvious, but, for example, routine use of epidurals is not supported by the evidence. 
Birth Matters Virginia

"Evidence based health care takes place when decisions that affect the care of patients are taken with due weight accorded to all valid, relevant information." 
Dr Nicholas Hicks

There is a never-never land that people believe we are heading towards, where our huge glut of information and meta-analyses, and  systematic reviews, and technological advances, will somehow be tamed so that we can quickly pick from any number of studies, the answer to a clinical question that is presenting itself. What is wrong with the picture is that we have become wrapped up in the science, or rather, in the scientific methods (or methods), and we have completely misplaced the person at the center: in our case, the pregnant, laboring, or breastfeeding woman.

I have in front of me an example of the type of study that is being used to support and  maintain evidence-based care. It is an "overview". This means that the researchers looked at reviews of trials. The trials are the actual clinical experiments, which are done on real people in real situations. The reviews are done when researchers look at, for example, ten different trials involving 10,000 women, and compare the results and draw conclusions.

This overview examines at several reviews that looked at pain management in labor. The conclusion is that:

"Most methods of non-pharmacological pain management are non-invasive and appear to be safe for mother and baby, however, their efficacy is unclear, due to limited high quality evidence. In many reviews, only one or two trials provided outcome data for analysis and the overall methodological quality of the trials was low. High quality trials are needed.
There is more evidence to support the efficacy of pharmacological methods, but these have more adverse effects. Thus, epidural analgesia provides effective pain relief but at the cost of increased instrumental vaginal birth.
It remains important to tailor methods used to each woman’s wishes, needs and circumstances, such as anticipated duration of labour, the infant's condition, and any augmentation or induction of labour.
A major challenge in compiling this overview, and the individual systematic reviews on which it is based, has been the variation in use of different process and outcome measures in different trials, particularly assessment of pain and its relief, and effects on the neonate after birth. This made it difficult to pool results from otherwise similar studies, and to derive conclusions from the totality of evidence. Other important outcomes have simply not been assessed in trials; thus, despite concerns for 30 years or more about the effects of maternal opioid administration during labour on subsequent neonatal behaviour and its influence on breastfeeding, only two out of 57 trials of opioids reported breastfeeding as an outcome. We therefore strongly recommend that the outcome measures, agreed through wide consultation for this project, are used in all future trials of methods of pain management." Jones L, Othman M, Dowswell T, Alfirevic Z, Gates S, Newburn M, Jordan S, Lavender T, Neilson JP. Pain management for women in labour: an overview of systematic reviews. Cochrane Database of Systematic Reviews 2012, Issue 3. Art. No.: CD009234. DOI: 10.1002/14651858.CD009234.pub2

So, what have we here? We have a "world where information is replacing the knowledge that displaced wisdom". (Birth Volume 36, Issue 1). We have a huge amount of man- and woman-hours being spent to gather and examine information.This information is considered to be the evidence, upon which we base our standards of care. The authors of this overview have come up with conclusions about the gathering and about the information. Let's look at the conclusions:
1. That the quality of the evidence-gathering was low, for various reasons.
2. Non-pharmacological methods of pain relief appear to be safe but may not work.
3. The effects of pharmacological pain relief on the baby has not been assessed.

From these conclusions, we can see that the researchers seem to have the best interest of mother and baby at heart. They want more studies on non-pharmacological methods of pain relief, and we get the feeling that they would like those studies to prove that these methods work. They want more studies to be done on the effects of maternal pain medications on the newborn, on breastfeeding and beyond, and we get the feeling that they would like these studies to lead to a decrease in use of pain medication,.

But it seems to me that here we are running into the late Phil Hall's suggestion that  "after initial gains in evidence-based medicine, we have moved from evidence-based decision-making to decision-based
evidence-making." (Birth Volume 36, Issue 1)
Make the decision that you would like to promote a more humane type of maternity care in your practice. Look at the studies that may support your hunches about how this can be facilitated. Draw your conclusions, make some protocol changes, and bingo!

The problem is thought, that studies can be deeply flawed and they can still be taken seriously. Let's go further with our overview:

It remains important to tailor methods used to each woman’s wishes, needs and circumstances, such as anticipated duration of labour, the infant's condition, and any augmentation or induction of labour.

What is this supposed to mean? I would say it is absolutely important to place the woman at the center of the whole event, where she belongs. Go as far as you can to fulfill her wishes. Cater to every one of her needs. But as soon as we start tailoring methods to a woman's circumstances, we get into trouble. Anticipated duration of labor, we all know, can often be wrong (is there a study?). The infant's condition of course is paramount, but are we then getting into continuous fetal monitoring? And are the authors suggesting that a woman should take an epidural before an oxytocin induction? (I'm not being facetious, it is offered frequently).

What's the biggest problem with this picture?  The whole overview completely missed out on one very important part of the equation. They mentioned massage, aromatherapy, sterile waters injections, TENS, and other methods as non-pharmacological, but nowhere in the overview does anyone mention the benefits of having one continuous presence - a companion, not the partner, but a companion who is trained to accompany women throughout labor and birth.

Let's take a look at the reality. Even during a traumatic, painful labor and an unexpected outcome, women feel better about their birth experience if they have been lucky enough to have had the presence of a doula. And isn't a positive experience for the new family what we are all trying to achieve?

The evidence is right there. You don't need to study or review. Just open your eyes, and then take the giant leap of trying to change practices and protocols.

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