Physicians Have an Ethical Obligation to be Honest Spokespersons for Medical Science ~

In the United States, physicians (MDs) are the natural spokespersons for the scientific discipline of allopathic medicine. While that status bestows many privileges, those privileges are matched by many responsibilities unique to the medical profession.

The very fact that Doctors of Medicine (MDs) are holders of a doctorate, the equivalent of a PhD in the science of allopathic medicine, gives the public and the press every good reason to believe that formal statements made by physicians in their areas of expertise about matters of health, safety, drugs, medical and surgical treatments, and medical research are, to the best of their ability, scientifically-based and factually correct and unbiased.

This scrupulous honesty and due diligence likewise applies to alternative forms of health care. However, if the MD has no training or direct experience and knows very little, that fact must be stated up front, and the physician’s due diligence requires that he or she refrain from expressing any opinions beyond recommending “more scientific inquiry” if warranted. 

The advanced education enjoyed by doctors comes with many social and economic benefits. This begins with an exclusive license to practice medicine and surgery, a privilege that includes an elevated legal status and level of public trust and respect.

Taken together, a unique burden is imposed by on physicians by the public in which people rightly expect MDs to be fully honest and accurate in their public communications.

This higher standard of ethical conduct for MDs  requires more of them than mere recitation of personal preference or professional self-promotion. Medical doctors have a duty to communicate only scientifically valid information in a public forum unless they identify such statements as a personal, political or corporate opinion.

As amply demonstrated by the literature, including professional journals, newspapers and articles published in popular magazines, some individual MDs, organizations and groups of those with a doctorate in medicine are not living up to their obligation to speak and act on the best scientific evidence.

This observation has been argued by state medical boards in regard to MDs hired to give ‘expert witness testimony’ in professional disciplinary cases and lawsuits. In many instances these regulatory agencies, and/or plaintiff attorneys, have insisted that a licensed physician as an “expert witness” has a legal or “due diligence” obligation to provide “honest, complete, and impartial information in their field of expertise“. This duty of diligence applies even though the MD was hired and paid by only one side in a disciplinary action or medical malpractice suit.

When it comes to the conducting of research relative to the profession of midwifery, and the rights of healthy childbearing women to choose childbirth services not based on the obstetrical model of care, this “due diligence” includes an ethical obligation for members of the obstetrical profession be unbiased when designing, conducting, interpreting, and publishing research on midwifery-based outcomes for mothers and babies, and statistically place-of-birth comparisons.

This ethical standard also applies to any public statements provided to the media, at press conferences, as well as and oral and written testimony rendered to government bodies or the courts based on such studies.

The burden of ethical conduct for MDs requires that they communicate only scientifically valid information in any public forum unless such statements are identified as a personal, political or corporate opinion, a personal or professional preference or identify themselves as communicating the policies or economic agenda of their particular professional organization (such as ACOG) or for organized medicine et al (AMA, CMA, etc) as a whole.

The public, including childbearing families and non-obstetrical maternity care providers (nurse-practitioners and professional midwives) insist that these same highly ethical principles apply to any and all OOH-PHB studies, statistical reports or other research that purports to define the comparative efficacy (relative safety & therapeutic plus cost-effectiveness) of intended place-of-birth, in particular, hospital vs. OOH. on “standard research characteristics” that are realistic and appropriate to the issue, scientifically-valided

If these research characteristics are absent, as they were in  and negative studies published by Pang, Wax and several others, then the study or research reports are not valid. 

Criteria for comparison between hospital and OOH-non-medical setting must be developed by those most intimately familiar with all parameters of non-medicalized, OOH care — midwives, parents, other kinds maternity care professionals (including one obstetrician) and birth activists and must accurately reflect the full-spectrum of reality. One example is the fact that a small number of healthy CB women, choose with fully informed consent to labor home despite a variety of moderate risk situations.

In particular, we must not permit place-of-birth research be turned into a proxy for medical vs non-medical care. Neither setting — hospital or OOH — have standard characteristics of care, a fact well documented and discussed by an Australian paper published about 10 years ago. All hospital births, due to a variety of factors include delivery in the ER driveway in a winter snow storm, include non-medicalized labor patients, while many birth attendants who provided planned OOH services use a consider about of surveillance technology and medical and surgical interventions when appropriate.

Overall, the standardized criteria developed by mothers and midwives and others must be validated by a multi-disciplinary panel of scientists and statisticians. It goes without saying that these individuals would be neutral to the content and topic of planned-place-of-birth — that is, knowledgable people who “don’t have a dog in this fight”. The review panel would also need to determine if the statistics are logical and reflect statistically-vaild methodology.

The first order of business is to actually define the full scope of the “Plan” in PHB/OOH, which is a many-phased process with reoccurring many opportunities and multiple reasons for the midwife to recommend and the mother to interface and/or transfer to medical services for evaluation or treatment.

It begins with the childbearing family and really describes a preference by the parents to give birth at home if both the mother and baby remain healthy and the labor progresses normally. There are three preconditions for this — agreement by the parents to appropriate use of medical services whenever it might become necessary, good-faith cooperation by the healthcare system in providing medical, surgical and neonatal services in a timely and appropriate fashion when required or requested by the parents, and a skilled and experience birth attendant who is present through-out the actives stages of 1st, 2nd and 3rd stage labor. 

The immutable a prior characteristics of the intention to remain in an OOH setting for childbirth includes:

(a) childbearing woman who is essentially healthy and pregnancy that is normal and both remain that way through-out antepartum period;

(b) spontaneous on-set of labor at term;

(c ) the CB women is initially evaluated by the birth attendant to determine whether mother and/or baby meets criteria for normal well-being at the onset of the professional’s OOH care and finds that it is initially appropriate to remain in an OOH setting;

(d) actively progressive labor that is tolerated by both mother and fetus. If any of these factors are missing or found to be negative, the outcome for mother and baby of that particular birth is not relative to the provision of professional care for a PHB/OOH birth.

If the mother or baby develops signs or symptoms of a complication, either ante- or intrapartum, if the laboring woman cannot or is not willing to cope with the pain of labor without drugs or anesthesia, if

As we know but ACOG/AJOG purposely ignores so-called ‘planned’ OOH birth. However, we insist that all outcome statistics for Planned Home/OOH Birth either be specific to the care received (outcomes for women who transfer to medical services prenatally or in desultory, prodromal or latent labor NOT identified as just that — i.e. comes are for elective transfer in antepartum or pre-active labor and whatever the outcome, it is NOT for a “planned home birth”.

Ditto for precipitous that occur before the midwife has been able to evaluate mother and baby, for premature births that occur precipitously at home (both categories are fatal flaws of PANG), for un-Attended births, and for un-Intended births. All these categories are fatal flaws of PANG, which were conveniently reiterated by WAX). 

In addition, we need a multi-disciplinary panel to adjudicate the fairness of any study (past, present or future) that claims to provide definitive data on the safety of plan OOH births. For example,

On my intrapartum record i chart when we cross the threshold described above to a truly planned home birth (regards of where the mother subsequently delivers), I chart that as a “declaration of PHB”.

I’m not suggesting that no outcomes for PHB can be counted unless or until the midwife has ‘declared’ its status as much as pointing out that the design for comparative place-of-birth studies needs to reflect the same criteria and it needs also to track the actual outcomes relative to whether the bulk of the care (over 80% of time in labor) occurred in the hospital under the obstetrical management.

When it come to research on planned place-of-birth, RCTs are never going to be part of the picture, but that doesn’t mean that researchers are not interested in collecting data. Unfortunately, a number of high-profile studies on place-of-birth have been designed by those with no direct experience or interest in OOH birth. Some researchers apparently started out with a strong prejudice against OOH settings or equally strong desire to definitively prove the greater safety of highly medicalized care. Most media reports of OOH research do not distinguish between well-done studies with useful information and those that were poorly done and arrived at mistaken or misleading conclusions.

As a result, the study’s conclusion — that planning an OOH birth doubled the risk of neonatal death (a statement widely circulated by the media) was based on this unreliable data.  A number of other studies that claim to prove hospital birth is safer or OOH more dangerous) have missing data, used poor methodology or other technical errors. This meant the study’s conclusions were not be supported by their own data.

Another example of this same problem is a recently published but much disputed OOH study — the Wax et al  meta-analysis available on-line on July 2, 2010. Out of 16,500 birth that (may or may not) have been planned to occur OOH, the Wax analysis recorded a total of 32 neonatal death.”  Twenty of these 32 deaths — nearly two-thirds — were taken from the 2002 study mention above that could not reliably determine whether an OOH birth was intended or not, or if the mother had been treated in the hospital for a considerable time during labor or if the baby was actually born in the hospital.

Even when planning status for OOH birth can be confirmed, the researcher still has the dilemma of what to do with appropriate transfers of women late in pregnancy for medical problems (breech baby, pre-term labor, PROM) or immediate transfer at the time of the initial labor evaluation to  due to discovery of a high risk condition such as bleeding, fever, thick meconium, etc. Since some percentage of women (or their babies) who planned an OOH birth will eventually need, want or receive hospital-based medical care, so the question is how to fairly determine place-of-birth outcomes relative to the mother’s choice of OOH.

If midwives transfer all the complications that occur in their OOH practices to the hospital, the stats for OOH (with all problems automatically eliminated) might unrealistically portray OOH birth as 100% safe, while hospital birth — recipient of all those complicated OOH transfers — would look (but not really be) more dangerous. In an attempt to circumvent this problem, outcomes have been assigned to the “intended” (planned) place of birth, no matter who actually provided care, or what type of care was actually provided or where the mother actually labored (in or out-of-hospital) or where the baby was actually born.

Studies that focus solely on the pregnant woman’s  plan to give birth OOH assign all subsequent data to the OOH-PHB cohort, even when a pregnancy risk factor or complication  was identified by the birth attendant and a necessary transfer of care was initiated long before labor. Another aspect of this confounding factor is assigning neonatal outcomes to OOH care even when the mother was transferred to the hospital early in labor and 80% (or more) of the intrapartum care was standard obstetrical management — IV, Pitocin, EFM, immediate access to Cesarean surgery, perinatology services at delivery, etc — for many hours before the baby was born in the hospital.

Unfortunately, this attempt to make the statistical comparison more fair means the outcome of the care as it was actually received is not correctly identified. The initial “intention” or preference of the family for a situation that never materialized becomes more relevant than the actual situation and type of medical care received.

Without knowing if the adverse events in question occurred at home with a professional (or experienced) attendant present (i.e., not a precipitous delivery before the midwife arrived) or happen in the hospital, or if the medical problem was avoidable vs. unavoidable, or if the parents declined prenatal testing or medically recommended treatments, there is no rational way to assess the impact of place-of-birth.

How the data for ‘intended’ place of birth is defined, collected and used makes a big difference. Done poorly, it merely trades one type of statistical dilemma for another, which means these particular OOH studies fail to answer the fundamental question of relative safety or  provide us with “actionable” information in designing public policies, educational curriculums and identifying ‘best practices’.

Newspaper reporters and media spokespersons naturally assume that each of these much touted studies was based on rock-solid data and impeccable methodology. This would includes a full forensically investigation of each of these deaths so that all facts were verified and a complete set of specific information was available for each bad outcome and that conclusions of the studies was internally consistent with the data. But that is not the case for the this small subset of studies aggressively promoted by ACOG. In fact, the opposite is true. Because these studies tells us so little about the proximal cause and circumstances surrounding each of these individual incidence of neonatal death, it keeps their authors and the rest of us from coming to meaningful conclusions. With such rare events and small numbers, each adverse event could and should be specifically confirmed and forensically evaluated.

OOH maternity care is an articulated model that purposefully includes policies and protocols for transfer of care as needed. This is no different than the  triage process used by small and medium-sized community hospitals. Hospitals routinely assess labor patients on admission for complications that require a higher level of medical service and arrange for those with such complications to be transported to tertiary care facility.

Nowhere in the scientific literature does one see maternal-infant outcome statistics used to evaluate a form of maternity care based on the hospital where the mother initially planned or preferred to give birth, but in fact did not actually give birth, either because she delivered elsewhere or developed a complication that required her to be transported to another facility. The current convoluted methodology of OOH birth would not be tolerated in any other aspect of modern healthcare and it is also not appropriate for place-of-birth research.

While the consensus of the scientific literature supports planned and attended OOH labor and birth as a responsible choice for healthy women with normal pregnancies and appropriate access to comprehensive obstetrical and perinal services as needed, the lack of “standard characteristics” for OOH studies does a great deal of mischief and causes no end of grief for the midwifery profession.

Studies on place-of-birth need to use standard scientific criteria that reduce personal bias and hidden political agendas, and inform public health officials and others who make policy decisions.

The only statistics on safety that are relevant to planned OOH birth are those that reflect outcomes for a normal term pregnancy that confirms the OOH status after onset of spontaneous labor and initial evaluation by the birth attendant. Only after the mother-to-be and her fetus are both confirmed to be essentially healthy and labor is at that point is normal can this mother’s labor and birth be documented as a planned OOH event. In addition, the actual place of birth, the timing of any transfer (how many hours before or after the birth) and the actual reasons for any labor or birth-related ‘bad outcome’ is crucial.

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