- Email: [email protected]
Guidelines on using guidelines
BJOG: an International Journal of Obstetrics and Gynaecology May 2002, Vol. 109, pp. 495 – 497
COMMENTARY
Guidelines on using guidelines Guidelines guide those in need of guidance along the line drawn by the guideline maker. This definition may seem facile but it exposes the limitations of guidelines. They are only useful to those who need guidance. They bring the outdated physician back into line, as recommended by the expert and they can be used to herd the weak and less focused down a politically expedient path. However, sophisticated medicine is an art. Quality holistic care comes from a caring physician who appreciates the global environment rather than a computer that is unaware of the wider picture. Guidelines should be based on powerful data distilled by great minds. However, it is wrong to rely on simple data from randomised trials because guidelines should be based on decision analysis, utility analysis or logic. Trials have limitations because they focus on single outcomes and may be flawed by selection bias, ascertainment bias and power limitations. For example, guidelines on fetal monitoring are based on clinical trials and conclude that routine CTG monitoring should not be used in low risk labour because there is no proven benefit. Despite the absence of statistical proof, many obstetricians have saved low risk babies because of the CTG. Medical negligence experts, judges and CESDI reports also conclude that proper CTG interpretation can prevent death and cerebral palsy even in low risk labours. The problem with the quoted trials is that the results are not applicable to modern CTG practice and the sample sizes are inadequate to detect a clinically important difference in intra-partum fetal death rates. CTGs certainly have disadvantages but these need to be assessed with decision and utility analysis. Another example of limited data influencing guidelines is the declaration that low risk women can be told that it is just as safe to deliver at home compared to a hospital. The limited data can be persuasive to mothers. The truth is that there is inadequate data to assess the differences. No evidence of beneficial effect is not evidence of no effect. Guideline can displace political influences. Unfortunately, the reverse can apply. A few years ago, medical oncologists were prevented from prescribing Taxol for ovarian carcinoma. At that time, three important clinical trials overwhelmingly favoured Taxol for first line therapy but NICE declined to support its use until the MRC reported the massive and high quality ICON 3 trial. NICE effectively ordered health authorities to support Taxol on the same day that the MRC revealed that Taxol had no measurable survival advantage. Furthermore, NICE went on to authorise Taxol for the management of recurrent D RCOG 2002 BJOG: an International Journal of Obstetrics and Gynaecology PII: S 1 4 7 0 - 0 3 2 8 ( 0 2 ) 0 2 0 0 4 - 9
ovarian carcinoma yet there are no useful trials to support this guideline. Guidelines can change public health policy. An example where the consequence of change may be detrimental is the current drive from Gynaecological Oncologists. The unashamed intention is to guide a flock of gynaecologists to a new place. Guidelines will force women with ovary cancer to have surgery in special centres. The intention of the guidelines is laudable but the existence of current randomised trials evaluating the role of surgery is proof that the role of surgery is unproven. Consequently, the need for centralisation is unproven yet the potential for collateral damage is obvious. For example, what will happen to the nursing staff deprived of radical gynaecological oncological surgery? What will happen to the young woman with a major obstetric haemorrhage in a hospital that doesn’t have a gynaecologist familiar with routine surgery on the internal iliac vessels? What will happen to the young woman who bleeds during endometriosis surgery and when there is no gynaecological oncologist to call on? Why should a woman travel from one end of Scotland to the other, leaving behind her family and friends for surgery in a centre when subsequent trials may even show that that surgery is detrimental to care? What will become of hospitals deprived of gynaecological oncology care that have to provide a surveillance programme but will now be denied expertise in holistic psychological nursing and medical care intrinsic to traditional gynaecological oncology? The policy makers disregard these obvious issues as they focus on flawed survival data and limited outcomes. The use and abuse of guidelines to build empires is not unique to gynaecological oncology. A prenatal diagnostician must be influenced by the unsubstantiated guidance relating to the number of chorionic villus biopsies performed each year to remain in practice. What does a hospital chief executive do when her unit does a limited number of prenatal tests a year? Is the chief executive going to say that the guideline is wrong or take the easy option of telling the obstetrician to stop doing chorionic villus biopsies? Is it really in the local community’s interest to stop very skilled practitioners performing this procedure simply because the average miscarriage rate is higher in the hands of some beginners compared to an established practitioner? Guidelines should be independent but consider infertility. The College guidelines basically conclude that all infertile women, with a few minor exceptions, should be www.bjog-elsevier.com
496
COMMENTARY
referred to major IVF units. Does it come as any surprise to learn that the policy makers were from hospital IVF units who will naturally be biased to selling IVF. This guideline deserves the same respect as the guidance from a drug company who says you should use their product. Guidelines should not be taken too seriously. For example, the guidelines of the Clinical Outcomes Group of the NHS Executive (COG) state that women with gynaecological cancer should be staged according to FIGO guidelines. It is ridiculous to assume that a young woman with a microinvasive cancer should be staged according to guidelines because this demands a chest x-ray and an IVP. All she needs is a simple excision in the outpatient clinic. COG guidelines state that women with ovary cancer should have optimal debulking surgery and this includes a total abdominal hysterectomy. It is ridiculous to assume that a woman with diaphragmatic disease from an ovarian serous papillary adenocarcinoma is going to benefit from having her cervix removed. It is intuitively obvious that this additional surgical manoeuvre could cause harm. However, failure to obey the guidance will be classified on an audit form as substandard care and bring criticism to the unit. A recent audit in the south and west showed that most hospitals were consistently failing to satisfy the audit criteria in about 30% of their cases. Perhaps this suggests that women with gynaecological cancer need to have their management individualised and guidelines are wrong in 30% of cases. Another example is the evidence-based guidance relating to forceps or Ventouse deliveries. The evidence is dominated by outcomes from the average obstetrician delivering the average woman who is also suitable for a trial and indifferent about her mode of delivery. The guideline does not consider the specific case of a woman with acute fetal distress who has the attendance of a traditionally trained British obstetrician. The guidelines recommend a Ventouse extraction. Guidelines help those who need guidance but an experienced practitioner does not need guidance to use rotational forceps when she is skilled and able. Audits show that babies can be delivered more rapidly with forceps compared to Ventouse when there is fetal distress. The guideline will also remove a potentially valuable tool as young Consultant obstetricians qualify without knowing why there are little dots on the handle of Kielland’s forceps. Guidelines can be abused in litigation. The quality of the British judiciary may surpass that of some third world tribes but medical negligence experts despair at the limitations of judicial insight. For example, the Royal College issued guidelines that all babies who are 10– 14 days overdue should be delivered by labour induction. This guideline comes from clinical trials that must, by definition, focus on the average woman and data will be restricted to common measurable outcomes. The established guidance promotes labour induction to all post dates pregnancies on the grounds that the intervention
probably doesn’t increase operative intervention rates. This clearly benefits a woman with a 3 cm effaced cervix who is exhausted because her pregnancy has gone 10 days beyond its expected date. However, induction of labour is about the most dangerous thing a modern obstetrician can do to a woman. Oxytocin is a powerful drug and you don’t need a clinical trial to tell you that it occasionally kills babies. Consider a woman who may have a long closed cervix, abundant liquor, perfect Doppler blood flow velocity studies and good fetal growth. The guidelines still instruct the obstetrician to promote labour induction. A good obstetrician will acknowledge the guidelines but be selective. Unfortunately, the risk manager will not have this skill. A good risk manager will want to see all such women induced simply to protect the hospital. Labour induction may be inappropriate in such a case but a hospital is vulnerable to litigation when national guidelines are contravened. Imagine a baby who suffers from cerebral palsy from an injury when the pregnancy is 15 days overdue. Counsel for the Claimant will simply say the injury would probably have been avoided if the guidelines had been followed and failure to induce labour represents a breach in the duty of care. Some guidelines fail to consider the resource consequences. Consider the guideline that all pregnant women should be offered an HIV test. This can be cost effective in high risk areas but the recommendation is irrational in regions where HIV does not exist. The guideline appears politically motivated and focuses on the only thing that interests the policy makers (HIV in London) without reference to the wider world. Nevertheless, the guidance will probably be enforced nationally. Many obstetric units can only comply by withdrawing other services despite the fact that their population has never been exposed to the HIV virus. There will be no significant gain and yet it will cause harm. Protocols are recipes. Guidelines tell us what to do. For example a culinary protocol tells you how to prepare the meal and the guidelines suggest that you do not drink red wine with white meat. Medical guidelines are usually based on the results of clinical trials and influenced by political pressure. As such they will be affected by fashion, the limitations of clinical research and will fail to individualise. Fortunately, most doctors use intelligence and ignore many guidelines. For example, 70% of doctors say they might ignore NICE’s recommendations. The worry is that some said they would ignore NICE’s view on a whim, despite the fact that the guidance has cost thousands of pounds and come from the world’s finest minds. At the end of the day, guidelines are a primitive tool for policy makers. They make a phenomenally important contribution to medicine by interfering with clinical freedom. This may sound like a disadvantage but clinical freedom is nothing more than the freedom to practice bad medicine. Guidelines do as their name D RCOG 2002 Br J Obstet Gynaecol 109, pp. 495 – 497
COMMENTARY
suggests, provide guidance — nothing more and nothing less.
Conflict of interest The author passionately supports evidence based medicine, believes in the American model of managed care and works as a regional subspecialist who stands to gain by the dictate that even more cases should be sent to his centre.
D RCOG 2002 Br J Obstet Gynaecol 109, pp. 495 – 497
497
Nick Johnson MRCOG, FRCS, PhD, DM Consultant, Department of Obstetrics & Gynaecology, Royal United Hospital in Bath and Senior Lecturer to the Universities of Bristol and Bath Tel.: 01225 824652, 07785 719059 (mobile); fax: 01225 874625/01225 825464. E-mail addresses: [email protected]; [email protected]
COMMENTARY
Guidelines on using guidelines Guidelines guide those in need of guidance along the line drawn by the guideline maker. This definition may seem facile but it exposes the limitations of guidelines. They are only useful to those who need guidance. They bring the outdated physician back into line, as recommended by the expert and they can be used to herd the weak and less focused down a politically expedient path. However, sophisticated medicine is an art. Quality holistic care comes from a caring physician who appreciates the global environment rather than a computer that is unaware of the wider picture. Guidelines should be based on powerful data distilled by great minds. However, it is wrong to rely on simple data from randomised trials because guidelines should be based on decision analysis, utility analysis or logic. Trials have limitations because they focus on single outcomes and may be flawed by selection bias, ascertainment bias and power limitations. For example, guidelines on fetal monitoring are based on clinical trials and conclude that routine CTG monitoring should not be used in low risk labour because there is no proven benefit. Despite the absence of statistical proof, many obstetricians have saved low risk babies because of the CTG. Medical negligence experts, judges and CESDI reports also conclude that proper CTG interpretation can prevent death and cerebral palsy even in low risk labours. The problem with the quoted trials is that the results are not applicable to modern CTG practice and the sample sizes are inadequate to detect a clinically important difference in intra-partum fetal death rates. CTGs certainly have disadvantages but these need to be assessed with decision and utility analysis. Another example of limited data influencing guidelines is the declaration that low risk women can be told that it is just as safe to deliver at home compared to a hospital. The limited data can be persuasive to mothers. The truth is that there is inadequate data to assess the differences. No evidence of beneficial effect is not evidence of no effect. Guideline can displace political influences. Unfortunately, the reverse can apply. A few years ago, medical oncologists were prevented from prescribing Taxol for ovarian carcinoma. At that time, three important clinical trials overwhelmingly favoured Taxol for first line therapy but NICE declined to support its use until the MRC reported the massive and high quality ICON 3 trial. NICE effectively ordered health authorities to support Taxol on the same day that the MRC revealed that Taxol had no measurable survival advantage. Furthermore, NICE went on to authorise Taxol for the management of recurrent D RCOG 2002 BJOG: an International Journal of Obstetrics and Gynaecology PII: S 1 4 7 0 - 0 3 2 8 ( 0 2 ) 0 2 0 0 4 - 9
ovarian carcinoma yet there are no useful trials to support this guideline. Guidelines can change public health policy. An example where the consequence of change may be detrimental is the current drive from Gynaecological Oncologists. The unashamed intention is to guide a flock of gynaecologists to a new place. Guidelines will force women with ovary cancer to have surgery in special centres. The intention of the guidelines is laudable but the existence of current randomised trials evaluating the role of surgery is proof that the role of surgery is unproven. Consequently, the need for centralisation is unproven yet the potential for collateral damage is obvious. For example, what will happen to the nursing staff deprived of radical gynaecological oncological surgery? What will happen to the young woman with a major obstetric haemorrhage in a hospital that doesn’t have a gynaecologist familiar with routine surgery on the internal iliac vessels? What will happen to the young woman who bleeds during endometriosis surgery and when there is no gynaecological oncologist to call on? Why should a woman travel from one end of Scotland to the other, leaving behind her family and friends for surgery in a centre when subsequent trials may even show that that surgery is detrimental to care? What will become of hospitals deprived of gynaecological oncology care that have to provide a surveillance programme but will now be denied expertise in holistic psychological nursing and medical care intrinsic to traditional gynaecological oncology? The policy makers disregard these obvious issues as they focus on flawed survival data and limited outcomes. The use and abuse of guidelines to build empires is not unique to gynaecological oncology. A prenatal diagnostician must be influenced by the unsubstantiated guidance relating to the number of chorionic villus biopsies performed each year to remain in practice. What does a hospital chief executive do when her unit does a limited number of prenatal tests a year? Is the chief executive going to say that the guideline is wrong or take the easy option of telling the obstetrician to stop doing chorionic villus biopsies? Is it really in the local community’s interest to stop very skilled practitioners performing this procedure simply because the average miscarriage rate is higher in the hands of some beginners compared to an established practitioner? Guidelines should be independent but consider infertility. The College guidelines basically conclude that all infertile women, with a few minor exceptions, should be www.bjog-elsevier.com
496
COMMENTARY
referred to major IVF units. Does it come as any surprise to learn that the policy makers were from hospital IVF units who will naturally be biased to selling IVF. This guideline deserves the same respect as the guidance from a drug company who says you should use their product. Guidelines should not be taken too seriously. For example, the guidelines of the Clinical Outcomes Group of the NHS Executive (COG) state that women with gynaecological cancer should be staged according to FIGO guidelines. It is ridiculous to assume that a young woman with a microinvasive cancer should be staged according to guidelines because this demands a chest x-ray and an IVP. All she needs is a simple excision in the outpatient clinic. COG guidelines state that women with ovary cancer should have optimal debulking surgery and this includes a total abdominal hysterectomy. It is ridiculous to assume that a woman with diaphragmatic disease from an ovarian serous papillary adenocarcinoma is going to benefit from having her cervix removed. It is intuitively obvious that this additional surgical manoeuvre could cause harm. However, failure to obey the guidance will be classified on an audit form as substandard care and bring criticism to the unit. A recent audit in the south and west showed that most hospitals were consistently failing to satisfy the audit criteria in about 30% of their cases. Perhaps this suggests that women with gynaecological cancer need to have their management individualised and guidelines are wrong in 30% of cases. Another example is the evidence-based guidance relating to forceps or Ventouse deliveries. The evidence is dominated by outcomes from the average obstetrician delivering the average woman who is also suitable for a trial and indifferent about her mode of delivery. The guideline does not consider the specific case of a woman with acute fetal distress who has the attendance of a traditionally trained British obstetrician. The guidelines recommend a Ventouse extraction. Guidelines help those who need guidance but an experienced practitioner does not need guidance to use rotational forceps when she is skilled and able. Audits show that babies can be delivered more rapidly with forceps compared to Ventouse when there is fetal distress. The guideline will also remove a potentially valuable tool as young Consultant obstetricians qualify without knowing why there are little dots on the handle of Kielland’s forceps. Guidelines can be abused in litigation. The quality of the British judiciary may surpass that of some third world tribes but medical negligence experts despair at the limitations of judicial insight. For example, the Royal College issued guidelines that all babies who are 10– 14 days overdue should be delivered by labour induction. This guideline comes from clinical trials that must, by definition, focus on the average woman and data will be restricted to common measurable outcomes. The established guidance promotes labour induction to all post dates pregnancies on the grounds that the intervention
probably doesn’t increase operative intervention rates. This clearly benefits a woman with a 3 cm effaced cervix who is exhausted because her pregnancy has gone 10 days beyond its expected date. However, induction of labour is about the most dangerous thing a modern obstetrician can do to a woman. Oxytocin is a powerful drug and you don’t need a clinical trial to tell you that it occasionally kills babies. Consider a woman who may have a long closed cervix, abundant liquor, perfect Doppler blood flow velocity studies and good fetal growth. The guidelines still instruct the obstetrician to promote labour induction. A good obstetrician will acknowledge the guidelines but be selective. Unfortunately, the risk manager will not have this skill. A good risk manager will want to see all such women induced simply to protect the hospital. Labour induction may be inappropriate in such a case but a hospital is vulnerable to litigation when national guidelines are contravened. Imagine a baby who suffers from cerebral palsy from an injury when the pregnancy is 15 days overdue. Counsel for the Claimant will simply say the injury would probably have been avoided if the guidelines had been followed and failure to induce labour represents a breach in the duty of care. Some guidelines fail to consider the resource consequences. Consider the guideline that all pregnant women should be offered an HIV test. This can be cost effective in high risk areas but the recommendation is irrational in regions where HIV does not exist. The guideline appears politically motivated and focuses on the only thing that interests the policy makers (HIV in London) without reference to the wider world. Nevertheless, the guidance will probably be enforced nationally. Many obstetric units can only comply by withdrawing other services despite the fact that their population has never been exposed to the HIV virus. There will be no significant gain and yet it will cause harm. Protocols are recipes. Guidelines tell us what to do. For example a culinary protocol tells you how to prepare the meal and the guidelines suggest that you do not drink red wine with white meat. Medical guidelines are usually based on the results of clinical trials and influenced by political pressure. As such they will be affected by fashion, the limitations of clinical research and will fail to individualise. Fortunately, most doctors use intelligence and ignore many guidelines. For example, 70% of doctors say they might ignore NICE’s recommendations. The worry is that some said they would ignore NICE’s view on a whim, despite the fact that the guidance has cost thousands of pounds and come from the world’s finest minds. At the end of the day, guidelines are a primitive tool for policy makers. They make a phenomenally important contribution to medicine by interfering with clinical freedom. This may sound like a disadvantage but clinical freedom is nothing more than the freedom to practice bad medicine. Guidelines do as their name D RCOG 2002 Br J Obstet Gynaecol 109, pp. 495 – 497
COMMENTARY
suggests, provide guidance — nothing more and nothing less.
Conflict of interest The author passionately supports evidence based medicine, believes in the American model of managed care and works as a regional subspecialist who stands to gain by the dictate that even more cases should be sent to his centre.
D RCOG 2002 Br J Obstet Gynaecol 109, pp. 495 – 497
497
Nick Johnson MRCOG, FRCS, PhD, DM Consultant, Department of Obstetrics & Gynaecology, Royal United Hospital in Bath and Senior Lecturer to the Universities of Bristol and Bath Tel.: 01225 824652, 07785 719059 (mobile); fax: 01225 874625/01225 825464. E-mail addresses: [email protected]; [email protected]