Raju TNK, Mercer BM, Burchfield DJ, Joseph GF. Periviable birth: executive summary of a Joint Workshop by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal-Fetal Medicine, American Academy of Pediatrics, and American College of Obstetricians and Gynecologists. J Perinatol. 2014.
I have previously mentioned the participation of Annie and me in the Workshop at the beginning of last year. We were very appreciative of being invited as the only non-Americans (I think) who presented, and I think it was a valuable process. On the other hand Annie and I were both a bit perturbed that there were no parents of preterms involved (except us, and maybe that was one reason we were invited). Many of us now feel that the time should be past when doctors get together in a room and decide on policy for the populus. We need to find ways to get input from families and from a wide variety of what I hate to call ‘consumers’ of health care.
Also there was a lot of debate and some areas of disagreement, so I did not envy the task of Tonse Raju and his co-authors in trying to summarize what went on. The Executive Summary that has now been published is, overall, a reasonable reflection of our discussions, but there are still some things that I am in disagreement with.
As one example there is a table of what obstetricians should do to mothers who present at high risk of extremely preterm delivery in the peri-viable period. I think we should be past this also: a list of what is and what is not recommended at varying gestational ages.
The table (3) includes, for example, that cesarean delivery is not recommended for fetal indications up to and including 22 weeks and 6 days, but then suddenly becomes recommended at 23 weeks and 0 days.
I will go over my litany of why I think this is mistaken, yet again. Firstly as we never know exactly the gestational age (except in cases of IVF) to make exact recommendations is irrational.
Secondly I think this recommendation must be nuanced and take into account the particular clinical circumstances of the mother, and her values and desires. I think there are many situations in which a cesarean delivery might be quite inappropriate for a mother who has passed the 23 week threshold, and that should be a decision for the woman and her doctor, (in concert with others, such as a partner). Surely the recommendation should be that the risks of extremely preterm cesarean are clearly explained to the mother, and an outline of what those risks are, without suggesting that as the clock ticks past midnight the OR should be called. The main additional risk of an extremely preterm cesarean, compared to one at term, is the risk to future pregnancies; so that is what needs to be discussed with the mother in addition to the overall risks of abdominal surgery (unfortunately it is hard to find good published data on this specific issue).
I could make similar comments about most items in the table, antenatal steroids for example. Even though the text introduces many of the other considerations, the table ends up over-simplifying the issues.
In contrast table 5 is a table of ‘Considerations regarding family counseling for anticipated or inevitable periviable birth’ and is to my mind a good reflection of our discussions, and an appropriately nuanced list of issues that need to be discussed with families.
|General||Providers should be aware of local standards (for example, hospital) and regulations (for example, state laws).|
|Counseling should be personalized and in the best interest of the family and their child, considering aspects beyond the gestational age.|
|Written guidelines should be developed by obstetric and neonatal teams with input from other stakeholders (for example, ethicists, nursing, administration, risk management and former NICU families).|
|Use protocols and checklists as adjuncts to proper counseling, and not as ‘stand-alone’ tools.|
|The institution should develop structured checklists and documentation processes to standardize use of counseling and obstetric and neonatal interventions, including newborn resuscitation.|
|The institution should provide for regular multidisciplinary conferences and teaching sessions.|
|Before and after counseling sessions||Obstetric and neonatal care providers should confer to avoid conflicting information. Obstetric and neonatal care providers should meet the parent(s) together if feasible. Post-counseling debriefing should occur to share and confirm the decisions (if any). Repeated counseling should occur as clinical circumstances change.|
|During counseling||Provide counseling in the families’ preferred language using trained professional interpreters as needed, and use family interpreter only if the family makes such a request.|
|Foster informed, collaborative decision making in an open, transparent and supportive atmosphere.|
|Seek out the family’s concerns and how they can be helped.|
|Content of counseling||Individualize the information to be provided, based on family preferences, wants and needs.|
|Some will want to receive detailed statistics, whereas others prefer hearing only the ‘big picture.’|
|Investigate how much the family wants to be directed in their decision-making process.|
|Consider the use of decision aids or other materials.|
|Recognize that the family’s wishes may be influenced by their cultural background, religious beliefs or both.|
|Specific information||Provide institutional data regarding survival and disability, if available. Otherwise, share regional, national or other population-based outcome information.|
|Provide information regarding available obstetric interventions, including their potential benefits and risks.|
|Provide information regarding the possibility of survival and disabilities separately.|
|Offer information regarding anticipated NICU care; provide more information about potential NICU stay according to family’s wishes: appearance of baby at birth, NICU complications, family-centered care in the NICU, provision of breast milk and so on.|
|Discuss options for comfort care and circumstances that might result in reconsideration of life-sustaining interventions.|
|Inform the family that the baby’s appearance at birth and Apgar scores are of limited prognostic value for survival and long-term morbidities.|
|State that infants born at extremely low gestational ages have a reduced survival and increased risks of adverse long-term outcomes.|
|Information given to families should include what some children cannot do because of disabilities and what many can do.|
|Mention adaptation and coping difficulties; the meaning of disability and the effect on families should be included.|
|Follow-up||Offer the family time to think about the information provided and needed decisions if circumstances permit. Encourage input by prospective parents’ important supports (for example, friends, family members and faith leaders) according to family preferences.|
I think if we can incorporate most of this into our counselling we will respond better to the needs of families.
We think that parents, grandparents and other consumers will increasingly be included in decision making about research and policy. Since 2005, the Australian National Health and Medical Research Council has recommended that consumers be partners and decision makers in the research process (http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/r33.pdf?q=publications/synopses/_files/r33.pdf). We and many others have explored these issues. (1-6).
In 2012 we held a two day workshop in Sydney: “Equipping parents and clinicians as partners in perinatal research” . Responses were very positive and several ideas for cementing such collaboration were proposed, which will be submitted for publication. The James Lind Initiative is a good example of collaboration between consumers and clinicians in setting research priorities. (6).
William Tarnow-Mordi, Director, WINNER Centre for Newborn Research, NHMRC Clinical Trials Centre, University of Sydney.
Melinda Cruz, parent and CEO, Miracle Babies Foundation, Sydney, Australia.
1. Wilkinson DJ, Gerrand N, Cruz M, Tarnow-Mordi W. The “research misconception”
and the SUPPORT trial: toward evidence-based consensus. Am J Bioeth. 2013;13(12):48-50. http://www.tandfonline.com/doi/abs/10.1080/15265161.2013.851297?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed&#.U2B4ZE1-_IU
2. Tarnow-Mordi, W., A. Keech, Cruz, M., Brite McCormick, K. Towards evidence-based consensus: Comment on Macklin R, Shepherd L, Dreger A, et al. The OHRP and SUPPORT—Another view. New England Journal of Medicine 2013; 369: e3. Available at: http://www.nejm.org/doi/full/10.1056/NEJMc1308015-t=comments
3. Tarnow-Mordi W, Simes J, Cruz M. Strategies to accelerate recruitment to NHMRC
multi-centre clinical trials. J Paediatr Child Health. 2013 Jan;49(1):E103-5.http://onlinelibrary.wiley.com/doi/10.1111/jpc.12061/pdf
4. Tarnow-Mordi WO, Cruz M, Wilkinson D. Evaluating therapeutic hypothermia:
parental perspectives should be explicitly represented in future research. Arch
Pediatr Adolesc Med. 2012 Jun 1;166(6):578-9.http://archpedi.jamanetwork.com/article.aspx?articleid=1171928
5. Tarnow-Mordi WO, Cruz M. Evidence-based neonatal medicine in Latin America:
what can we learn from the International Neonatal Immunotherapy Study and trials
of IVIg? J Pediatr (Rio J). 2012 Sep-Oct;88(5):369-71.http://www.jped.com.br/ArtigoDetalhe.aspx?varArtigo=2347&idioma=pt-BR
Click on the English title to see the whole commentary in English
6. Chalmers I. The James Lind Initiative. J R Soc Med. 2003 Dec;96(12):575-6. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC539653/pdf/0960575.pdf