24h-payday

Archive

Posts Tagged ‘safety’

Pregnancy and Childbirth Advice Books through the Lens of Preeclampsia

July 3rd, 2012 by avatar

Guest post by Science & Sensibility contributer Christine H. Morton, PhD

(Full disclosure:  the organization I work for, CMQCC, has been working with representatives from the Preeclampsia Foundation over the past year on the CMQCC task force developing a Preeclampsia Toolkit, and I am a big fan of their executive director, Eleni Tsigas, and frequent re-tweeter of @preeclampsia).

The Preeclampsia Foundation released a new guide to pregnancy and birth books last month, a comprehensive report distilled from a review of more than 60 such books, on their accuracy, coverage and clarity of information on hypertensive complications in pregnancy.    As readers of S&S are well aware, there are numerous books geared to expectant couples, pregnant women, and male partners; by authors who claim their authority by virtue of their clinical degrees and practice, their teaching and research credentials, as well was their personal and celebrity experience.   This is the first time I’ve seen a guide to pregnancy and birth advice books from the lens of a serious disorder in pregnancy:  preeclampsia.

May was Preeclampsia Awareness Month. Hypertensive disorders of pregnancy, including elevated blood pressure, preeclampsia, eclampsia and HELLP syndrome are estimated to affect 12-22% of pregnant women and their babies each year.1 Preeclampsia is a leading cause of pregnancy-related death in the US and in the state of California, and one of the most preventable. Adverse neonatal outcomes are higher for infants born to women with pregnancies complicated by hypertension. Care guidelines have recently been developed in many countries, including the UK, Canada and Australia, with a revised practice bulletin to be released from ACOG later this year. A key focus in many of these guidelines is accurate measuring of Blood Pressure, and standardized pathways of care, depending on the clinical situation. These guidelines note that one reason for their creation is the clear evidence that the surveillance of women with suspected or confirmed preeclampsia is variable between practitioners.2,3
 Seeking to understand their experience, women turn to books, their childbirth educators and doulas to help them navigate through this new and unexpected turn into complicated pregnancy.   While many women have healthy pregnancies and births, those who are having symptoms, or have been diagnosed with preeclampsia, eclampsia or HELLP syndrome, need accurate and clear information.    Early detection, and treatment, is a proven way to lessen the severity of the disease, and mitigate its impact.  Are some pregnancy and childbirth guidebooks better than others in informing readers about these issues?

To answer this question, researchers Jennifer Carney, MA and Douglas Woelkers, MD reviewed more than 60 pregnancy and childbirth advice books and ranked them using a consistent set of criteria in five categories: Depth of Coverage, Placement of Coverage, Clarity and Accuracy of Information, Description of Symptoms, and Postpartum Concerns.  In their methods section, they note that

“Books were downgraded for out-of-date information, missing or inaccurate information and placement issues, including inaccurate or inadequate indexing.    Of the more than 60 books reviewed, none ranked above “8” in all five categories. In fact, only a handful of books scored above “8” in the category of “Postpartum Concerns,” since many books routinely state that the cure for preeclampsia and related disorders is the birth of the baby.”

Childbirth educators and doulas have strong views on the ‘best’ books to guide women through pregnancy and childbirth and might be surprised to find that even best selling books like Ina May’s Guide to Childbirth (2003) scored only a 2.6, while the much excoriated, yet highest selling advice book: What To Expect When You’re Expecting (2009) ranked last in the Preeclampsia Foundation’s TOP TEN list, with a score of 7.2.  All books reviewed are listed in the Appendix of the report.

One helpful feature of the report is a sampling of questionable claims found in pregnancy guidebooks:

“Preeclampsia never happens before the twentieth week, but your blood pressure may start to rise steadily after this. Delivery of the baby and placenta ends the problem.” From Conception, Pregnancy, and Birth by Miriam Stoppard. In rare instances preeclampsia can occur prior to 20 weeks; it can also occur up to six weeks postpartum.

The report further explains why it’s important for books on childbirth to also mention preeclampsia, eclampsia and HELLP Syndrome, since this disease can develop immediately prior to, during or after delivery.  Among the childbirth books, the reviewers found,

Only Penny Simkin’s book The Birth Partner: A Complete Guide to Childbirth for Dads, Doulas, and All Other Labor Companions (2007) provides adequate information about preeclampsia, eclampsia, and HELLP syndrome. Although this book incorrectly uses the term pregnancy-induced hypertension (PIH) to describe preeclampsia and eclampsia, it provides a useful list of symptoms and the possible treatments, including cesarean delivery. It also presents some of the emotional issues that might arise from a diagnosis of PIH and includes some information on HELLP syndrome. It acknowledges the possibility of postpartum preeclampsia and eclampsia, something that many of the general pregnancy books omit.

The report can help childbirth educators and doulas point women to the best information about hypertensive disorders, but its authors also hope these results will guide authors in future revisions.  At the very least, up to date terminology, accurate information and complete indexing is critical in revisions. Books geared primarily to women with relatively healthy pregnancies always face the challenge of balancing reassurance, the optimality of physiological birth and the diverse range of potential complications in pregnancy.  Yet such books can point readers to resources like the Preeclampsia Foundation for up-to-date and user-friendly information and community pages.

Take-away points for Childbirth Educators and Doulas:

  • Check your website and be sure to link to Preeclampsia Foundation website for unbiased, evidence-based information on this disease.  They are on Facebook too.
  • Tell your students to ask about their blood pressure at all prenatal visits and during labor.  They should know what their ‘normal’ range is, and if their BP is ever above 140 systolic or 90 diastolic, to be alert to signs and symptoms of preeclampsia, and report these changes to their care providers.
  • Many factors can affect BP readings:  BP cuff size should be appropriate, especially among women with a high BMI; the measurement should be taken while sitting, with arm at heart level; automated BP machines may underestimate the BP.
  • Remind pregnant women (and their partners) that although lots of attention will naturally be focused on the baby, they have to be alert to the new mother’s health symptoms postpartum too.  While postpartum is a whole new normal, women need to know that any significant bleeding, fever, headaches, nausea, or visual disturbances, are NOT normal, and they should follow up with their health care provider immediately.

Preeclampsia is a serious, if unlikely, complication of pregnancy.  Women diagnosed or at risk for developing hypertensive disorders of pregnancy can find accurate information for all literacy levels (and some Spanish language resources), as well as a supportive community at the Preeclampsia Foundation, a US-based 501(c)(3) not-for-profit organization whose mission is to reduce maternal and infant illness and death due to preeclampsia and other hypertensive disorders of pregnancy by providing patient support and education, raising public awareness, catalyzing research and improving health care practices.

 References

1. American College of Obsetricians and Gynecologists. Diagnosis and management of preeclampsia and eclampsia; ACOG Practice Bulletin No. 33. Obstetrics & Gynecology. 2002;99:159-167.

2. Repke JT PM, Holzman GB, Schulkin J. Hypertension in Pregnancy and Preeclampsia: Knowledge and Clinical Practice Among Obstetrician-Gynecologists. Journal of Reproductive Medicine. 2002;47(6):472-476.

3. Caetano M OM, von Dadelszen P, Hannah ME, Logan AG, Gruslin A, Willan A, Magee LA. A Survey of Canadian Practitioners Regarding Diagnosis and Evaluation of the Hypertensive Disorders of Pregnancy. Hypertens Pregnancy. 2004;23(2):197-209.

4.  Hogan JL, et al.  Hypertens Pregnancy. Body Mass Index and Blood Pressure Measurement during Pregnancy. 2011;30(4):396-400.  PMID: 20726743

Read more about Christine H. Morton, PHD on our contributor page.

 

 

 

 

Book Reviews, Childbirth Education, Guest Posts, informed Consent, Maternity Care, Medical Interventions, Patient Advocacy, Practice Guidelines, Pre-eclampsia, Pregnancy Complications, Uncategorized , , , , , , , , , , , , , , , ,

Caring for Survivors of Sexual Abuse Throughout the Childbearing Journey

April 25th, 2012 by avatar

A guest post by Deborah Issokson, Psy.D.

Childbearing is a vulnerable process.

Regardless of our profession within the childbirth world, we are working to facilitate an experience that has a positive emotional outcome accompanied by a healthy psychological adjustment to motherhood. It is incumbent upon us to understand and be sensitive to all the ways in which childbearing can be both triggering and potentially healing for women with abuse histories.

It is crucial to remember that not all survivors will have the same experience of pregnancy, birth, postpartum and breastfeeding. And we cannot assume that all women experiencing difficulties with aspects of childbearing such as pelvic exams, touch, immodesty, language, and pain are abuse survivors.

For an abuse survivor, abuse memories may be triggered by the physical changes, social and psychological tasks, medical procedures, and rituals of childbearing.

For some, abuse memories and emotions will be familiar, expected; others may experience these memories as regressive in their healing. For still others, the memories and emotions will be unexpected and intrusive, signaling the first time they are coming forth.

Preserving the Mental Health of Sexual Abuse Survivors

From a mental health perspective, the task with an acknowledged sexual abuse survivor during childbearing is threefold: help her maintain her current level of functioning, help her contain the memories, and facilitate further healing using childbearing as a vehicle for growth.

If the woman is unaware of her abuse history, we may be in the position of suspecting it or listening to her share her own inklings based on the feelings, concerns, fears and distress that she is experiencing and we are observing.

However, the Pandora’s box of sexual abuse memories must be opened delicately. Ideally, pregnancy is a time of containment as a woman grows a baby inside her body, preparing psychologically and spiritually for motherhood. And while birth is a time of opening and transforming, it is also a time when we want to limit extraneous, stressful stimuli so that a woman can immerse in her transformation to motherhood.

Strategies for Childbirth Professionals

So what do we do, in our respective roles, to meet these goals, implement these tasks and stay mindful of pacing, timing and professional limitations and boundaries?

  • We can encourage a woman to review coping strategies she has previously employed.
  • We can encourage her to seek support from a therapist, partner, friends, a support network.
  • We can help her stay grounded by contextualizing her physical changes and discomforts, reviewing the real and appropriate changes happening in her body, reflecting on her health and resilience and helping her pace herself as she adjusts to the changes.
  • We can be instrumental in helping a woman explore her choices for place of birth, care providers, and birth intentions. Her choice of provider and the manner in which she makes her choices may be affected by her abuse history and by the gender of her abuser. She may choose a provider and a place of birth that could facilitate a healing experience for her. On the other hand, she may unconsciously recreate the dynamics she experienced with her abuser.

Women wonder about sharing their abuse story with everyone who cares for them, be it the medical provider, the educator, the doula or the breastfeeding counselor. While it isn’t necessary to tell the entire story, it can be helpful for certain providers to have a general sense of the history in order to be sensitized to the woman’s issues as they pertain to prenatal care, labor and delivery, postpartum care and breastfeeding assistance.

If a woman is working with a group practice or being taught by a revolving set of educators, she may not want to repeat her story for each provider. Rather, we can encourage her to share with one provider with whom she feels most comfortable, asking that a brief note be put in her chart to inform the others. We can also suggest she write a brief statement herself, highlighting what she most wants her providers to know about her story, her vulnerabilities and her coping strategies.

Emotional dynamics of birth and transition to parenting
For an abuse survivor, normal fears, anxieties and concerns about birth can take on additional psychic charge due to the physical and sexual nature of birth.

On one end of the continuum is the experience of giving birth as healing; on the other end is the feeling that birthing is tantamount to a recurrence of sexual abuse. In between are shades of gray.

Most births have healthy, uncomplicated physical outcomes; the emotional outcome is not so predictable. There is no telling how a woman will experience her birth and how she will make meaning of it. As a witness to her birth, we may perceive it as wonderful, empowering and successful, while the woman may have a completely different emotional experience and perception.

Furthermore, the emotional outcome is an unfolding process for the postpartum woman. The new mother spends part of her postpartum year reviewing and dissecting her birthing experience. It is not unusual for the survivor of abuse, years later, to have a new perspective on her experience. Sometimes it is a more healing perspective.

For an abuse survivor, the postpartum period can be a time of consolidation of past healing efforts as she enters a phase of parenting and protecting a new human being.

For other women, parenting can be the catalyst for new memories and flashbacks, new conflicts with extended family, and even regression in the healing process. Survivors of abuse are at high risk for experiencing postpartum depressive and anxiety disorders. These mental health issues require attention and treatment as soon as possible as they have a detrimental impact not only on the woman, but also on her baby and her entire family.

Empower by Giving Space to the Individual Woman
As providers of care, we are often witness to great courage, strength and healing as survivors of sexual abuse journey toward parenthood.

Empower your client to shape this childbearing experience for herself. Ideally, your work together can culminate in a positive emotional experience of pregnancy and birth, a healthy connection between mother and baby, and a sense of self-efficacy as a mother.

REFERENCES

Issokson, Deborah. 2004. Chapter 11, Effects of Childhood Abuse on Childbearing and Perinatal Health in Health Consequences of Abuse in the Family: A Clinical Guide for Evidence-Based Practice, K. Kendall- Tackett, editor. Washington D.C.: American Psychological Association.

Kendall-Tackett, K. 1998. Breastfeeding and the sexual abuse survivor. Journal of Human Lactation, 14(2), 125-130.

Simkin, Penny and Phyllis Klaus. 2004. When Survivors Give Birth: Understanding and Healing the Effects of Early Sexual Abuse on Childbearing Women. Washington: Classic Day Publishing.

Sperlich, Mickey and Julia Seng. 2008. Survivor Moms: Women’s Stories of Birthing, Mothering and Healing after Sexual Abuse. Oregon: Motherbaby Press.

Deborah Issokson, Psy.D, is a licensed psychologist in Massachusetts specializing in Perinatal Mental Health. She is a contributor to several editions of Our Bodies, Ourselves. She was a faculty member of the Boston University School of Public Health, lecturing on Maternal and Child Health (now closed). She  can be reached at info@reproheart.com. Visit her website at www.reproheart.com.

Childbirth Education, Depression, Evidence Based Medicine, Guest Posts, Healthy Care Practices, informed Consent, Maternal Mental Health, Perinatal Mood Disorders, Postpartum Depression, Research, Survivors of Sexual Abuse , , , , , , , , ,

Root Cause Analysis: Turning a needless maternal death into better care for all

November 18th, 2010 by avatar

On the morning of July 5, 2006, a 16-year-old patient came to St. Mary’s Hospital in Madison, Wisconsin, to deliver her baby. During the process of her care, an infusion intended exclusively for the epidural route was connected to the patient’s peripheral IV line and infused by pump. Within minutes, the patient experienced cardiovascular collapse. A cesarean section resulted in the delivery of a healthy infant, but the medical team was unable to resuscitate the mother. The medication error and its consequences were devastating for the patient’s family, the nurse who made the error, and the medical team that labored to save the patient’s life.

This is the real story of a tragic and unnecessary maternal death that occurred not in a mud hut in a third world country, nor in a backwater rural health clinic—but in a fully licensed and accredited 440-bed community teaching hospital that delivers more than 3,500 babies annually and serves as a regional referral center for all of south-central Wisconsin. In a highly unusual and commendable move, senior management at St. Mary’s requested an outside independent investigation of this event and published their findings in an effort to share painful lessons learned with the medical community and the public.

What happens when an unanticipated maternal death occurs? If the event occurred in a hospital accredited by the Joint Commission on Accreditation of Healthcare Organizations (“Joint Commission”), the hospital must complete a root cause analysis (RCA) as a first step. Since 1996, a total of 84 cases of maternal death have been reported to The Joint Commission. The lessons learned from these most extreme patient care outcomes, also called “sentinel events,” have widespread implications for everyone involved in maternal and infant care. As William M. Callaghan, M.D., M.P.H., senior scientist in the Division of Reproductive Health at the Centers for Disease Control and Prevention remarked, “Maternal deaths are the tip of the iceberg, for they are a signal that there are likely bigger problems beneath – some of which are preventable,” says Dr. Callaghan. “It is important to consider the women who get very, very sick and do not die, because for every woman who dies, there are 50 who are very ill, suffering significant complications of pregnancy, labor and delivery.”


What is a root cause analysis?

Root cause analysis, or RCA, is “a process for identifying the basic or causal factors that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event.” The RCA seeks to answer these questions: What happened? Why did it happen? What will we do to prevent this from happening again? The RCA is not about assigning blame, but rather identifying the direct and indirect contributing factors –latent system errors—that create the “perfect storm” in which the event occurred.

The RCA process might seem deceptively simple. We may be tempted to approach the RCA in the following manner:

What happened? The patient mistakenly received an IV infusion of epidural medication.

Why did it happen? The nurse hung the wrong IV bag.

What we will do to prevent this from happening again? Fire the nurse.

Indeed, this overly simplistic and ineffective “shame and blame” approach is the one that many hospitals take in conducting internal investigations of adverse medical events. A more thorough and credible RCA digs at the underlying factors and causes by asking a series of “Why?” questions, which might look something like this:

What happened?

The patient mistakenly received an IV infusion of epidural medication.

Why did it happen?

The nurse hung the wrong IV bag.

Why did the nurse hang the wrong IV bag?

Because she confused the epidural bag with the IV penicillin bag which were next to each other on the counter.

Why were the bags next to each on the counter?

Because the work flow process included having epidural medications and supplies set up and ready in the room ahead of time.

Why did the work flow process include having analgesia medication in the room ahead of time?

Because anesthesia had in the past expressed dissatisfaction with nursing staff over patients’ state of readiness for epidurals.

And,

Why did the nurse hang the wrong IV bag?

Because she confused the epidural bag with the IV penicillin bag.

Why did the nurse get confused?

Because she was tired.

Why was the nurse tired?

Because she had worked two consecutive eight-hour shifts the day before, then slept in the hospital before coming on duty again the following morning.

Why did she work consecutive shifts?

Because she was covering for another colleague and her departure would have left the unit inadequately staffed.

As we repeatedly ask “Why?” we start to see groups of factors emerge, and these groups can help us to organize our thinking and later, to identify remedies. These groups might include: patient characteristics, task factors, individual staff factors, team factors, work environment, and organizational and management factors. We can map these factors and groups onto a fishbone diagram, a commonly used RCA visual aid:
(Click on graphic for improved viewing)

Now you try it!
Although root cause analyses are most commonly performed in cases of serious permanent physical or psychological harm, we can apply these same principles to “near-miss” events and instances of suboptimal, although not lethal, care. Read Rima Jolivet’s thought-provoking allegorical tale of two births. As you compare the two women’s stories, consider the factors that contributed to Karen’s negative birth experience. Even if the causes were not stated explicitly in the article, draw upon your own experience as a birthing professional and fill in the gaps. Think about:

  1. Patient characteristics: Are there pre-existing or co-morbid medical conditions, physical limitations, language and communication barriers, cultural issues, social support needs that play a role?
  2. Task factors: What protocols and procedures are in place for labor and delivery, for use of analgesia, for dystocia, for C-sections? Are they safe? Are they practical? Are they effective? Are they consistently applied?
  3. Individual staff: How did the knowledge, skills, training, motivation, and health of Karen’s providers affect her care?
  4. Team factors: How well do the various health care professionals involved in Karen’s care work together? What is the nature of the communication? Are there hierarchies? What is the responsiveness of nursing supervisors or attending physicians? How easily can a team member ask for help or clarification?
  5. Work environment: Is the labor and delivery unit adequately staffed? What is the workload? What happens when the census fluctuates unexpectedly? What is the staffing level of experience, functionality of the equipment, quality of administrative support?
  6. Organizational and management factors: How do the values of the hospital translate into clinical practice? Do their standards and policies focus more on patient safety and quality of care, or volume and speed? Are management’s priorities patient- or provider-centered? Does senior leadership foster a culture of teamwork and safety or blame and shame?

Add your comments below, and I will include them in a root cause analysis of Karen’s case in my next blog post.

References:

Jolivet, R. “Two Birth Stories: An Allegory to Compare Experiences in Current and Envisioned Maternity Care Systems.” Childbirth Connection, 2010. http://www.childbirthconnection.org/pdfs/allegory_illustrating_vision.pdf

“PS104: Root Cause and Systems Analysis.” Institute for Healthcare Improvement Open School for Health Professions. http://www.ihi.org/IHI/Programs/IHIOpenSchool/.

“Sentinel Event Alert: Preventing Maternal Death.” The Joint Commission. Issue 44, January 26, 2010. http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_44.htm

“Sentinel Event Policy and Procedures.” The Joint Commission. July 2007. http://www.jointcommission.org/NR/rdonlyres/F84F9DC6-A5DA-490F-A91F-A9FCE26347C4/0/SE_chapter_july07.pdf

Smetzer J, Baker C, Byrne FD, Cohen MR. “Shaping Systems for Better Behavioral Choices: Lessons Learned from a Fatal Medication Error.” Jt Comm J Qual Patient Saf. 2010 Apr; 36(4):152-63. http://psnet.ahrq.gov/public/Smetzer-JCJQPS-2010-s4.pdf

Uncategorized , , ,

Medical Error Disclosure and Risk of Malpractice Litigation

September 10th, 2010 by avatar

An analysis of “Liability Claims and Costs Before and After Implementation of a Medical Error Disclosure Program,” by Kachalia et. al, Annals of Internal Medicine, 2010; 153:213-221. [Patient summary and abstract available here.]

Two weeks ago, I was invited to speak to a group of family medicine residents about patient safety. I gave what I thought was a heartfelt appeal for greater openness in communication between physicians and patients. Afterwards, one faculty member approached me privately and remarked that, although many physicians would agree in theory that honesty, transparency, and disclosure are all good and right things to do for patients in the aftermath of a serious adverse event, it was unlikely to happen unless a business case could be made and it could be shown that such an approach would not put hospitals and clinicians in further financial or legal jeopardy. His comment got me thinking and digging to see if there was indeed any cold, hard evidence in the literature supporting open disclosure. I didn’t have to dig long before seeing the headlines from USA Today…

USA Today

In August, an article published in Annals of Internal Medicine took a close look at the relationship between disclosure of medical errors and liability risk. The authors conducted a retrospective analysis comparing legal claims made and costs to a major academic medical center and health system, over a roughly 12-year period before and after implementation of a medical error disclosure program. Since 2001, the University of Michigan Health System (UMHS) has practiced a comprehensive claims management program emphasizing honesty, transparency, and disclosure—sometimes with compensation—to injured patients and encouraging reporting of errors by staff.

The results of the study challenge current medical malpractice paradigms. All of the study’s measures—number of new claims for compensation, number of claims compensated, time to claim resolution, and claims-related costs—decreased in the period after program implementation compared with the period before. (Note: the authors defined a claim as “any request for compensation for an unanticipated medical outcome whether initiated by the patient or by disclosure.” Although some claims did end up as lawsuits, the vast majority both before and after program implementation did not). Specifically,

  • Number of new claims for compensation decreased from 7.03 claims per 100,000 patient encounters before initial program implementation to 4.52 after full implementation. This decrease was due almost entirely to a drop in the number of lawsuits filed, and there was no change in the rate of claims that did not result in a lawsuit.
  • Median time to claim resolution decreased from 1.36 years before program implementation to 0.95 years after.
  • Total liability costs decreased after full program implementation and were attributable to decreases in both legal and patient compensation costs. Again however, although the total costs associated with lawsuits decreased (from $405, 921 to $228,308 per lawsuit) after full implementation of the UMHS Disclosure-with-Offer Program, the total costs for nonlawsuit claims did not.

Like any ambitious study, especially one of this size and duration, the UMHS study has limitations. Among them:

  • How much of the decrease in claims litigation is due specifically to UMHS program efforts as opposed to other variables in the healthcare climate during the study period? The authors noted that, during the same time as implementation of the UMHS program and study period, the entire state of Michigan also experienced an overall drop in liability claims and costs thought to be attributable to state-wide malpractice reform instituted in 1994.
  • What are the implications of a disclosure program that results in a decrease in the number of lawsuits filed, but no change in the number of claims that do not proceed to a lawsuit and an overall decrease in patient compensation? Many patients lack the resources to file a lawsuit and only a very small proportion of injured patients ever receive compensation, let alone in sufficient amounts, for medical negligence and harm that they have suffered.
  • What about caregivers practicing outside of a large medical center setting? The physicians in this study were all covered by the university under a group malpractice insurance program. The UMHS systems approach also meant that reporting of individual practitioners to the National Practitioner Data Bank was rare, a policy without which healthcare professionals and staff might be discouraged from reporting errors. For practitioners who purchase their malpractice insurance separately or who are engaged in private practice, it’s not clear whether the findings from this study are applicable.

Despite the study’s limitations, what is clear is that a medical error disclosure program does not automatically open hospitals or health systems up to more lawsuits and higher legal costs. The implications could be significant for a “high-risk” field like obstetrics where medical malpractice is no stranger and in which one wrong move during a short window of time can have enormous and lifelong medical, financial, and psychological consequences for a mother, her baby, and her family. Under the traditional “defend and deny” risk management strategy that has been in play for decades at most large hospitals and birthing centers, lawyers and practitioners operate on assumptions that admitting error is an invitation to a lawsuit and would open the floodgates to vengeful patients seeking large payouts for frivolous claims. These assumptions, grounded and perpetuated in fear, misunderstanding, and incomplete information, are major barriers to sound patient safety and ethical principles that support open disclosure of harmful medical errors.

The UMHS findings also confirmed what many patients, patient safety advocates, and healthcare professionals have long known about the mitigating effects of open disclosure on litigation. Paul Levy, CEO of the Beth Israel Deaconess hospital in Boston and author of the popular blog “Running a Hospital,” wrote recently:

The literature on the topic of disclosure and apology suggests that patients and families are not interested in having the doctor or nurse be punished when a medical error occurs, if (and this is an important if), the clinician makes clear that he or she is clearly regretful about the error, is empathetic with the patient, and if the clinician and hospital show that they plan to learn from the error to help avoid repeats with other patients.

So it looks like full disclosure is not only good medicine, but good business too.

Uncategorized , ,

Much ado about “levator microtrauma”: Do epidurals protect the pelvic floor?

September 3rd, 2010 by avatar
Levator Ani

The levator ani is a muscle, not a clinical outcome.

Ok, ok, I’ve heard from enough of you about the study purportedly showing that epidurals protect the pelvic floor, I suppose it’s time to write up what I think about it.  First, a little about the study from the (overzealous) journal press release. I couldn’t resist doing a little bit of [line editing] on it:

Researchers from Australia undertook a prospective study of 488 women undergoing their first pregnancy between May 2005 and February 2008. The object of the study was [to determine predictors of delivery mode, but since they had enrolled all of those pregnant women they designed some other studies, too. In one, the researchers invited those 488 women to return for follow up at 3-4 months and retrospectively analyzed data on the 367 women who did] to determine if there are any risk factors during birth which may result in levator trauma including macrotrauma (large scale avulsion – tearing) and microtrauma (damage to the muscle tissues such as irreversible overdistention of the pelvic floor opening). Researchers believed that the findings from their study may help modify obstetric practice to help prevent levator injury…

No levator avulsion was recorded in the women who had a caesarean section. Levator avulsion was diagnosed in 13% of women who had a vaginal birth (9% of whom had had a vacuum delivery and 35% of whom had had a forceps delivery). Researchers found that forceps delivery was associated with a three to four-fold increase in levator avulsion. [They excluded the 13% of vaginal births in which levator avulsion was diagnosed and evaluated the rest of the women for "microtrauma". We put "microtrauma" in quotes because no one has ever defined or determined the prevalence of this "condition". The researchers invented it themselves! But anyway,...] Postbirth assessment showed that the longer the 2nd stage of labour, the higher the likelihood of microtrauma. Women who had an intrapartum epidural were found to have had a lower incidence of microtrauma. The researchers suggest that epidurals, because they relax the muscles through paralysis, may be beneficial in preventing levator trauma.

There are multiple problems with the press release and, for that matter, with the study itself. Christine Kent at Whole Woman Village Post does a nice job of reviewing some of them, including the fact that one of the study authors receives money from incontinence surgical device companies and ultrasound companies. But I’d like to focus on the use of “levator microtrauma” as the outcome reported.

Levator microtrauma is an example of a surrogate outcome (sometimes referred to as a surrogate endpoint). As defined by Temple (1995):

A surrogate endpoint of a clinical trial is a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that measures directly how a patient feels, functions or survives. Changes induced by a therapy on a surrogate endpoint are expected to reflect changes in a clinically meaningful endpoint. [emphasis mine]

But as D’Agostino (2000) argues, some surrogate outcomes are extremely poor predictors of actual outcomes, and changing clinical practice based on studies that report only surrogate outcomes can be a major threat to patient safety if the therapy introduces other risks. So the questions we should ask ourselves when we see a study reporting a surrogate outcome are:

  • is the surrogate outcome a good predictor of a clinically important outcome (i.e., “how a patient feels, functions or survives”)?
  • does the treatment pose any excess risks over other alternatives to achieving that clinically important outcome?

In the case of “levator microtrauma,” there is absolutely no data whatsoever linking the author’s definition of microtrauma to pelvic organ prolapse or other important pelvic floor problems such as incontinence or sexual dysfunction. The aforementioned corporate-sponsored researcher showed in an earlier study that macrotrauma (aka levator avulsion) is an appropriate surrogate for pelvic organ prolapse, but remember that epidurals were not associated with macrotrauma in this study. Forceps deliveries were – and what’s the major modifiable risk factor for forceps delivery?  Epidurals!

But let’s say that microtrauma does lead to pelvic floor problems and that, therefore, epidural analgesia in labor may be a strategy for preventing those pelvic floor problems.  Is encouraging epidural analgesia in a woman who might otherwise forgo it the best strategy for preventing pelvic floor problems?  Maybe doing away with coached pushing, fundal pressure, episiotomy, and supine positioning might be the better strategy. Maybe postpartum exercises can help reverse changes associated with pregnancy and vaginal birth so they don’t turn into symptomatic pelvic floor problems.

Like other studies that report surrogate outcomes, this study is not useless.  It provides some data that can help us understand how epidurals affect pelvic floor muscle tone and strength and alter the process of vaginal birth, and I’ll be the first to say that we need more research in those areas. In other words, these data on a novel surrogate outcome can help us design more studies, not guide patient care.

Anyone who has even a basic understanding of clinical research should recognize that we need much more data before we can say that epidurals may help prevent future pelvic floor prolapse.  Oh wait, the editor-in-chief of a major international obstetric journal just said exactly that! In the headline of a major press release!

*headdesk*

Reference:

Temple RJ. A regulatory authority’s opinion about surrogate endpoints. Clinical Measurement in Drug Evaluation. Edited by Nimmo WS, Tucker GT. New York: Wiley; 1995.

Uncategorized , , , , ,