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Process and pitfalls in the development of practice guidelines for obstetric anesthesia
International Journal of Obstetric Anesthesia (2000) 9, 1–2 © 2000 Harcourt Publishers Ltd
EDITORIAL
Process and pitfalls in the development of practice guidelines for obstetric anesthesia Why do we need practice guidelines at all, much less for obstetric anesthesia and how did they come about? When the American Society of Anesthesiologists (ASA) approved and published the Guidelines for Obstetrical Anesthesia,1 they were the tenth in a series of clinical practice guidelines developed under the direction of the ASA Practice Parameters Committee. The past decade has seen a surge of interest in use of clinical practice guidelines in all specialties, driven by the findings of large unexplained variation in physician practice, documentation of significant rates of inappropriate care (not specifically in anesthesiology), and an interest in managing costs in the era of managed care.2,3 Practice guidelines are meant to describe clinical practices supported by outcome studies in the literature and ‘expert’ clinical opinion. Although not intended as standards or absolute requirements, they should be supportive of usual clinical practices. Frequently practitioners are concerned that guidelines will be used against them in some way, but they are really meant to bring in the outliers; in other words if someone’s clinical practice lies far outside those described in these or any other guidelines, the practitioner should re-examine their basis for choosing that method of clinical care. When the ASA Practice Parameters Committee chose obstetric anesthesia as an area to develop practice guidelines, it was based on the diversity of clinical practice settings in this subspecialty and the perceived differences in how things were done (e.g. should post partum tubal litigations be delayed 8 hours or 24 hours or done immediately or not at all?) and how they were billed (e.g. do you charge absolute time for labor epidurals or a global fee or cap your time charges after a certain number of hours?). Thus, the ASA appointed a Task Force on Guidelines for Obstetrical Anesthesia composed of 10 members from diverse geographic areas and a variety of private and academic settings, including an obstetrician/perinatologist. The Task Force first decided which areas in obstetric anesthesia would and would not be covered in the guidelines, since this was not meant to have the breadth of a textbook. An independent group of epidemiologists directed the literature search and performed the statistical analyses. When there were
questions which could not be answered through the literature, a group of 147 ‘experts’ were polled. The group consisted of anesthesiologists and obstetricians in all areas of the country in both private and academic practices. These experts answered surveys to describe their practices and opinions about controversial topics and practice in obstetric anesthesia. The Task Force members found it disconcerting to discover that many of our most cherished beliefs had no basis in fact! It was the responsibility of the epidemiologists to gently lead us back to reality while we vehemently stated that ‘everyone’ knew that’s how it should be done, despite the fact there was nothing to support it in the literature. Another surprise was how differently our own practices were from each other’s. A number of heated discussions began with ‘Why in the world would you do that?’ especially after a long day around the conference table. The epidemiologists kept us ‘honest’ by diligently searching for support for our ideas but not allowing us to include them if the literature was absent or insufficient and we were not supported by our expert consultants. After about 18 months, with the time consumed with deciding on topics, reviewing the literature, surveying our experts and composing a draft document (with several meetings, hours of phone calls, and piles of faxes and e-mails behind us), we set out to see what our colleagues thought. The draft document was presented at two meetings as open forums. These were times when anyone who wanted could come and see what we had written and make positive and negative comments. The Task Force members were sometimes taken aback at the vehemence with which some practitioners reacted to our ideas or the way we had worded them. However, after some deep breaths (and a few stiff drinks), we took the comments to heart and made a better document with them. The use of public criticism of the draft document through an open forum proved extremely beneficial. After the two Open Forums we revised the draft again and again. When we thought we had the best document possible we placed it on the ASA website for 3 months. This allowed anyone who wanted to comment before it went to the House of Delegates. In part, the use of the website allowed us to get more feedback from the 1
2
International Journal of Obstetric Anesthesia
general membership, but it was also done in selfdefense. Practice guidelines in other areas had been rejected by the ASA’s House of Delegates because of the perception that the House hadn’t had time to review or comment adequately. When the House of Delegates voted on the document in October 1998, no changes were allowed; it could only be a ‘yes’ or ‘no’ vote, and we wanted everyone to be ready to say ‘yes’. All the Task Force members were in contact with our State Societies, District Directors and other important ‘political’ players to be sure they all understood why the document contained the recommendations it did and we encouraged them to support the document. During the writing of the document, two issues were particularly controversial. At Northridge Hospital in California a woman was denied an epidural for labor because of the inability to provide a co-pay to the anesthesiologist to supplement her Medicaid (MediCal) coverage.4 The case generated considerable coverage by the media, a lawsuit against the anesthesiologist and outrage among anesthesiologists either: (1) because they couldn’t believe she’d been denied the epidural for inability to pay or (2) because they couldn’t believe anyone should be required to do obstetrical anesthesia for the remarkably low MediCal reimbursement rates. We wrote and rewrote the introduction to the section on Anesthesia Care for Labor and Delivery until we felt it encompassed the concerns on both sides. The final section reads (in part): ‘Anesthesia care is not necessary for all women for labor and/or delivery. For women who request pain relief for labor and/or delivery, there are many effective analgesic techniques available. Maternal request represents sufficient justification for pain relief, but the selected analgesia technique depends on the medical status of the patient, the progress of the labor, and the resources of the facility. When sufficient resources (e.g. anesthesia and nursing staff) are available, epidural catheter techniques should be one of the analgesic options offered.’ Another unexpected difficulty came when writing the recommendations for ‘Fasting in the Obstetric Patient.’ Not only was there nothing in the literature to support or refute any particular time interval or allowable intake policy, but the Task Force and our consultants had no consensus either. Even the wording for the amount of clear liquids to be allowed in labor (finally described as ‘modest amounts’) was
agonized over for hours. When our ‘experts’ were surveyed, the nil per os (NPO) time in their hospitals for elective procedures varied from 6–12 hours in most cases but with considerable variability. Since the literature did not support (or refute) any particular NPO interval for elective obstetric cases, we concluded that ‘The patient undergoing elective cesarean delivery should have a fasting period for solids consistent with the hospital’s policy for non-obstetric patients undergoing elective surgery.’ Overall, the recommendations in the Guidelines are well supported. The final usable database from the literature search produced over 500 articles from 55 journals. There were 53 meta-analyses performed. There was extensive input to the final recommendations from the ‘expert consultants’, attendees of the open forums and the general membership of the ASA via the web site. Most reassuring, in a final survey of the 147 consultants, about 97% indicated that implementing the recommendations would not require any change in their clinical practices – in other words, the recommendations are well within usual clinical practice. The guidelines will be revisited and revised in about 2 years and newly published literature is already being collected for inclusion. We all like to think we are practicing science-based medicine in obstetric anesthesia, but clearly that will require more outcome studies. Each time it is noted in the guidelines that the literature was insufficient, inconclusive or silent, there’s a need for someone to tackle a study in that area. Let’s get busy! Joy L. Hawkins MD Chairman, ASA Task Force on Obstetrical Anesthesia REFERENCES 1. Task Force on Obstetrical Anesthesia: Practice Guidelines for Obstetrical Anesthesia. Anesthesiology 1999; 90: 600–611. 2. Chassin MR, Brook RH, Park RE et al. Variations in the use of medical and surgical services by the Medicare population. N Eng J Med 1986; 314: 285–290. 3. Chassin MR, Kosecoff J, Park RE et al. Does inappropriate use explain geographic variations in the use of health care services? A study of three procedures. JAMA 1987; 258: 2533–2537. 4. Cohen S. Labor epidural analgesia: Back to the dark ages or a political win-win situation? International Journal of Obstetric Anesthesia 1999; 8: 223–225.
EDITORIAL
Process and pitfalls in the development of practice guidelines for obstetric anesthesia Why do we need practice guidelines at all, much less for obstetric anesthesia and how did they come about? When the American Society of Anesthesiologists (ASA) approved and published the Guidelines for Obstetrical Anesthesia,1 they were the tenth in a series of clinical practice guidelines developed under the direction of the ASA Practice Parameters Committee. The past decade has seen a surge of interest in use of clinical practice guidelines in all specialties, driven by the findings of large unexplained variation in physician practice, documentation of significant rates of inappropriate care (not specifically in anesthesiology), and an interest in managing costs in the era of managed care.2,3 Practice guidelines are meant to describe clinical practices supported by outcome studies in the literature and ‘expert’ clinical opinion. Although not intended as standards or absolute requirements, they should be supportive of usual clinical practices. Frequently practitioners are concerned that guidelines will be used against them in some way, but they are really meant to bring in the outliers; in other words if someone’s clinical practice lies far outside those described in these or any other guidelines, the practitioner should re-examine their basis for choosing that method of clinical care. When the ASA Practice Parameters Committee chose obstetric anesthesia as an area to develop practice guidelines, it was based on the diversity of clinical practice settings in this subspecialty and the perceived differences in how things were done (e.g. should post partum tubal litigations be delayed 8 hours or 24 hours or done immediately or not at all?) and how they were billed (e.g. do you charge absolute time for labor epidurals or a global fee or cap your time charges after a certain number of hours?). Thus, the ASA appointed a Task Force on Guidelines for Obstetrical Anesthesia composed of 10 members from diverse geographic areas and a variety of private and academic settings, including an obstetrician/perinatologist. The Task Force first decided which areas in obstetric anesthesia would and would not be covered in the guidelines, since this was not meant to have the breadth of a textbook. An independent group of epidemiologists directed the literature search and performed the statistical analyses. When there were
questions which could not be answered through the literature, a group of 147 ‘experts’ were polled. The group consisted of anesthesiologists and obstetricians in all areas of the country in both private and academic practices. These experts answered surveys to describe their practices and opinions about controversial topics and practice in obstetric anesthesia. The Task Force members found it disconcerting to discover that many of our most cherished beliefs had no basis in fact! It was the responsibility of the epidemiologists to gently lead us back to reality while we vehemently stated that ‘everyone’ knew that’s how it should be done, despite the fact there was nothing to support it in the literature. Another surprise was how differently our own practices were from each other’s. A number of heated discussions began with ‘Why in the world would you do that?’ especially after a long day around the conference table. The epidemiologists kept us ‘honest’ by diligently searching for support for our ideas but not allowing us to include them if the literature was absent or insufficient and we were not supported by our expert consultants. After about 18 months, with the time consumed with deciding on topics, reviewing the literature, surveying our experts and composing a draft document (with several meetings, hours of phone calls, and piles of faxes and e-mails behind us), we set out to see what our colleagues thought. The draft document was presented at two meetings as open forums. These were times when anyone who wanted could come and see what we had written and make positive and negative comments. The Task Force members were sometimes taken aback at the vehemence with which some practitioners reacted to our ideas or the way we had worded them. However, after some deep breaths (and a few stiff drinks), we took the comments to heart and made a better document with them. The use of public criticism of the draft document through an open forum proved extremely beneficial. After the two Open Forums we revised the draft again and again. When we thought we had the best document possible we placed it on the ASA website for 3 months. This allowed anyone who wanted to comment before it went to the House of Delegates. In part, the use of the website allowed us to get more feedback from the 1
2
International Journal of Obstetric Anesthesia
general membership, but it was also done in selfdefense. Practice guidelines in other areas had been rejected by the ASA’s House of Delegates because of the perception that the House hadn’t had time to review or comment adequately. When the House of Delegates voted on the document in October 1998, no changes were allowed; it could only be a ‘yes’ or ‘no’ vote, and we wanted everyone to be ready to say ‘yes’. All the Task Force members were in contact with our State Societies, District Directors and other important ‘political’ players to be sure they all understood why the document contained the recommendations it did and we encouraged them to support the document. During the writing of the document, two issues were particularly controversial. At Northridge Hospital in California a woman was denied an epidural for labor because of the inability to provide a co-pay to the anesthesiologist to supplement her Medicaid (MediCal) coverage.4 The case generated considerable coverage by the media, a lawsuit against the anesthesiologist and outrage among anesthesiologists either: (1) because they couldn’t believe she’d been denied the epidural for inability to pay or (2) because they couldn’t believe anyone should be required to do obstetrical anesthesia for the remarkably low MediCal reimbursement rates. We wrote and rewrote the introduction to the section on Anesthesia Care for Labor and Delivery until we felt it encompassed the concerns on both sides. The final section reads (in part): ‘Anesthesia care is not necessary for all women for labor and/or delivery. For women who request pain relief for labor and/or delivery, there are many effective analgesic techniques available. Maternal request represents sufficient justification for pain relief, but the selected analgesia technique depends on the medical status of the patient, the progress of the labor, and the resources of the facility. When sufficient resources (e.g. anesthesia and nursing staff) are available, epidural catheter techniques should be one of the analgesic options offered.’ Another unexpected difficulty came when writing the recommendations for ‘Fasting in the Obstetric Patient.’ Not only was there nothing in the literature to support or refute any particular time interval or allowable intake policy, but the Task Force and our consultants had no consensus either. Even the wording for the amount of clear liquids to be allowed in labor (finally described as ‘modest amounts’) was
agonized over for hours. When our ‘experts’ were surveyed, the nil per os (NPO) time in their hospitals for elective procedures varied from 6–12 hours in most cases but with considerable variability. Since the literature did not support (or refute) any particular NPO interval for elective obstetric cases, we concluded that ‘The patient undergoing elective cesarean delivery should have a fasting period for solids consistent with the hospital’s policy for non-obstetric patients undergoing elective surgery.’ Overall, the recommendations in the Guidelines are well supported. The final usable database from the literature search produced over 500 articles from 55 journals. There were 53 meta-analyses performed. There was extensive input to the final recommendations from the ‘expert consultants’, attendees of the open forums and the general membership of the ASA via the web site. Most reassuring, in a final survey of the 147 consultants, about 97% indicated that implementing the recommendations would not require any change in their clinical practices – in other words, the recommendations are well within usual clinical practice. The guidelines will be revisited and revised in about 2 years and newly published literature is already being collected for inclusion. We all like to think we are practicing science-based medicine in obstetric anesthesia, but clearly that will require more outcome studies. Each time it is noted in the guidelines that the literature was insufficient, inconclusive or silent, there’s a need for someone to tackle a study in that area. Let’s get busy! Joy L. Hawkins MD Chairman, ASA Task Force on Obstetrical Anesthesia REFERENCES 1. Task Force on Obstetrical Anesthesia: Practice Guidelines for Obstetrical Anesthesia. Anesthesiology 1999; 90: 600–611. 2. Chassin MR, Brook RH, Park RE et al. Variations in the use of medical and surgical services by the Medicare population. N Eng J Med 1986; 314: 285–290. 3. Chassin MR, Kosecoff J, Park RE et al. Does inappropriate use explain geographic variations in the use of health care services? A study of three procedures. JAMA 1987; 258: 2533–2537. 4. Cohen S. Labor epidural analgesia: Back to the dark ages or a political win-win situation? International Journal of Obstetric Anesthesia 1999; 8: 223–225.