- Email: [email protected]
Consent in prenatal diagnosis
Current
Ohsrerrics
& Gynaecology
( 1999)
9. I70-
172
0 1999 Harcourt Publishers Ltd
Medico-legal/education
Consent in prenatal diagnosis
I. Montague and I? Soothill
should be avoided because the GMC guidelines state: ‘the fact that a patient lies down on an examination couch does not in itself indicate that the patient has understood what you propose to do and why’.
INTRODUCTION Informed consent is the fundamental requirement for successful relationships between health-care professionals and patients, and is based on trust. Consent is founded on the ethical principle of patient autonomy - the patient’s right to chose based on their personal values and beliefs. Historically, some doctors took a paternalistic attitude to treatment following the ethical principle of beneficence’ - trying to judge the best interests of the patient in order to guide their clinical practice. This, however, is no longer accepted in our society and recently the issue of informed consent has been a matter of heated debate in medical journals and the subject of a set of guidelines from the General Medical Council (GMC).?
COUNSELLING CONSENT
AND INFORMATION
CONSENT
Consent in obstetric care is more complex than in any other field of medicine because of the possible consideration of two patients. Almost always, pregnant women wish the best for their fetus. However. in exceptional circumstances, a woman may choose to decline a course of action which medical evidence would strongly support. However bizarre her decision, assuming the mother is mentally competent, in the UK the mother’s rights are paramount. No procedure for the benefit of the fetus (or mother) can be performed without full maternal consent and this principle of autonomy is enshrined in law.’ In the case of a mentally incapacitated patient, the doctor must assess the patient’s ability to make an informed decision about the treatment. If a woman lacks the capacity to give consent but decides to comply with a treatment which is judged to be in her best interest, then a doctor can proceed. If, however, the patient does not comply or the treatment is controversial, approval by a court should be sort.? Initially, in counselling, information and options should be explained in a non-directive manner, but if a patient is still undecided, a counsellor should then again confirm that the woman understands all issues involved. However, it is not acceptable to give information and desert the patient to make up their own mind if they are struggling with the decision. If she is still undecided it can be reasonable to give advise and guidance, but this should only occur late in counselling process and with caution.
FOR
Accurate information forms the major part of any consent. Informed consent requires the patient to be fully aware of the nature of the test or procedure; including its aims, limitations, possible complications, success rates, the consequences of the results and alternative options. Having understood these, the patient must then make a decision to consent before undergoing the procedure. The GMC have clearly stated that the person obtaining consent must be suitably trained and qualified, and have sufficient knowledge of the proposed investigation or treatment to be able to obtain informed consent.? ‘Implied consent’ lmogen Montague MRCOG, Professor Peter Soothill MD MRCOG Fetal Medicine Research Unit. University of Bristol. St. Michael’s Hospital, Southwell Street, Bristol BSZ, UK Correspondence
IN OBSTETRICS
IO: F S.
170
Consent in prenatal diagnosis
Prc-screening
counsflliog
(Community)
171
Table 1 Patient information required for informed consent in prenatal diagnosis Nature of condition for which the diagnostic test is being offered Accuracy of the test Possible complications of the procedure Possible consequences of a positive result Possible false-positive or false-negative results
J, Clmwll J, Screening test Y
Y “High risk”
*Low risk”
+ Port screening counrelling JI
Y
Diagnostic lcsl
(Hospilnl wting IFMU)
Dcclinc
J, Abnormal
(llospilill setting)
Y rewlt
Normal
+ Cuunrclling
% Conocnt
(Dedicated FMU)
Y
c
+
Y
TOP
Fetal TX.
Intensive
Coosenalive
prcnntnl
ig. I
Mx.
(nature taku its count)
Pre-screening counselling
‘ONSENT IN PRENATAL
DIAGNOSIS
‘onsent should be an integral part of every prenatal iagnosis procedure.4 Many patients have strong per)nal. cultural. ethical and religious views which irect decision-making in pregnancy. Unfortunately, it :ems that women often proceed with investigations ffered without the knowledge required to give [formed consent.5 (Table 1). Although concerns have :en raised that full informed consent can be alarmlg to women.6 It appears that in other areas of medine, giving full details of possible consequences and )mplications as part of the consent process has been lown not to be psychologically harmful.’
ONSENT AND SCREENING IAGNOSIS
IN PRENATAL
xeening is an area in prenatal diagnosis in which formed consent has often been neglected and counmlling before any medical screening procedure is andatory.’ Counselling requires the patient to be vare of the nature of the condition being screened r, the accuracy of the screening test and the possible msequences of false-positive or false-negative sults. Surveys have shown that even the majority of
women undergoing serum screening for Down syndrome do not understand the limitations and inaccuracies of the test, and often the fault is in the information given. Ii As a rule, in the UK, counselling initially takes place in the primary health care setting. Studies have shown a poor understanding of screening procedures both by midwives and general practiti0ners.j With a change in working practices of midwives by rotating between hospital and community settings, we fear the problem of maintaining and updating the knowledge of those counselling for serum screening may grow. Continuing education of staff in how to provide clear information before any screening test is essential. Another major problem in the UK is that different health authorities have different screening policies.9.‘u Screening should be performed in an organized and supervised way and with standardized information agreed by health-care professionals involved in the service. The use of written information in the form of booklets has been shown to be only partly successful. The information contained is very variable in quality, and a significant proportion of women fail to read literature given to them at booking.” Recently, concern has been raised following a screening procedure being performed without patient consent’? and indeed to apply a screening test to an individual without consent would be unethical. This principle applies to both ‘opt-in or opt-out’ screening programmes because the argument that to improve the uptake (and so the success) of a screening programme by making it ‘opt out’ is, therefore, wrong since every woman should both understand and consent (and, therefore, opt-in) before any test is done (Fig. 1).
CONSENT AND SCANNING DIAGNOSIS
IN PRENATAL
Ultrasound scanning is now an essential component of normal obstetric care, but its use at any stage of pregnancy has the potential to diagnose a fetal abnormality if present. Most women attending for routine scanning are at low risk of a fetal abnormality and the scan is for them the first opportunity to ‘see’ their baby. Indeed, many appear unaware that one of the aims of a scan may be to diagnose a fetal abnormality.13 A consequence of this is that parents are often poorly prepared for bad news or possible uncertainty of normality. Before any scanning the patient should
172
Current Obstetrics & Gynaecology
be made aware of the purpose of the scan, the possibility of a problem being detected arId the degree of uncertainty with scan diagnosis. Such pre-scan counselling should constitute a routine part of antenatal care. Even with informed choice, the uptake of ultrasound anomaly screening seems to be markedly above that which would be expected for other prenatal screening tests and this uptake has been attributed to the overwhelming desire to ‘see the baby’.lJ
positive outcomes. Even in the presence of fetal abnormalities, the parents can be prepared for the possible outcomes and management options, and allow them to meet during the pregnancy the teams which will be involved after delivery. However, these benefits from prenatal diagnosis have, as yet, not been objectively measured or assessed scientifically.
CONCLUSION SELECTIVE
CONSENT
IN SCANNING
A few women will not want to know when an abnormality is suspected at a routine scan. However, once a problem has been identified this information cannot be withheld from the parents unless this has been discussed and agreed beforehand. It is important to realise that in such cases, a woman might chose to opt out of the ‘anomaly’ aspect of a scan, but still benefit from accurate dating, placental localization and viability assessment.ls
CONSENT
FOR INVASIVE
FETAL TESTING
Women identified as being of higher risk from past history or screening may often have more time to consider their options but they should have detailed counselling before undergoing any invasive test. Such counselling should take place in a hospital setting, by a specialist and usually in a defined fetal medicine unit. Careful informed consent is a major part of fetal-medicine practice. It is possible that clinicians who do not have a special interest may be unaware of certain rare consequences of a procedure, such as failed cytogenetic culture, confined placental mosacism or maternal contamination. Best practice which includes continuous ultrasound visualization of the needle throughout any invasive test is still not used by some obstetricians and this practice should be actively discouraged.
OTHER POSSIBLE BENEFITS PRENATAL TESTING
FROM
Counselling for consent in prenatal diagnosis should include the important information that termination of a pregnancy with a severe fetal abnormality is only one objective of diagnosis. ‘6~‘7The ability to optimize appropriate antenatal surveillance fetal therapy, timing of delivery and the option to deliver in units with paediatric surgical facilities if appropriate are other
Informed consent is an essential component of every aspect of prenatal diagnosis.18 In both screening and routine scan assessment, counselling and consent should be obtained before any investigation. REFERENCES I.
Chervenak E McCullough L. Ethics, an emerging subdiscipline of obstetric ultrasound, and its relevance to the routine obstetric scan Ultra. Obstet Gynecol 1991; I: IS-20 GMC. Seeking patient’s consent: the ethical considerations 1999. London: General Medical Council MB (I 117) 2 FCR 541. 38 BMLR 175 Marteau TM Towards informed decisions about prenatal testing: a review. Prenat Diagn 1995; I5( 13): 1215-1226 Gekas J. Gondry J, Mazur S, Cesborn P. Thepot F, Informed consent to serum screening for Down’s syndrome: are women given adequate information? Prenat Diagn 1999; 19: I-7 6. Oliver S, Rajan L, Turner H et al. Informed choice for users of health services: views on ultrasonography leaflets of women in early pregnancy. midwives and ultrasonographers. BMJ 1996; 313: 1251-1253 I. Keerigan D, Thavasagayam R, Woods T et al. Who’s afraid of informed consent? BMJ 1993: 306: 298-300 8. Sadler M. Serum screening for Down’s syndrome: how much do health professionals know? Br J Obstet Gynaecol 1997: 104: 176179 9. Dormandy E. Better understanding of factors influencing uptake is needed BMJ. 1998; 3 IS: 805 IO. Dodds R. The stress of tests in pregnancy: summary of a National Childbirth Trust antenatal screening survey. London: National Childbirth Trust. 1997 II. Marteau TM, Slack J. Kidd J, Shaw RW. Presenting a routine screening test in antenatal care: practice observed. Public Health 1992; 106: 131-141 12. Venn-Treloar J. Nuchal translucency - screening without consent. BMJ 1998: 316: 1027 13. Proud J, Murphy-Black T. Choice of a scan: how much information do women receive before ultrasound. Br J Midwifery 1997; I: 144-147 14. Baillie C, Mason G. The psychological impact of obstetric ultrasound scans and soft marker screening. Imaging 1997; 9: 115-122 15. Ballie C, Hewison J. Obtaining selective consent to scanning, rather than screening, is possible BMJ 1999: 318: 805 16. Royal College of Obstetricians and Gynaecologists study group. Statistical aspects of screening for Downs Syndrome. In: Grudzinskas JG, Ward RHT (eds.) Screening for Down syndrome in the tirst trimester. London: RCOG Press, 1997 17. Carroll S. Measurements give parents useful information BMJ 1998; 317: 748 18. McFadyen A, Gledhill J. Whitlow B. Economides D. First trimester ultrasound screening. BMJ 1998; 317: 694695
Ohsrerrics
& Gynaecology
( 1999)
9. I70-
172
0 1999 Harcourt Publishers Ltd
Medico-legal/education
Consent in prenatal diagnosis
I. Montague and I? Soothill
should be avoided because the GMC guidelines state: ‘the fact that a patient lies down on an examination couch does not in itself indicate that the patient has understood what you propose to do and why’.
INTRODUCTION Informed consent is the fundamental requirement for successful relationships between health-care professionals and patients, and is based on trust. Consent is founded on the ethical principle of patient autonomy - the patient’s right to chose based on their personal values and beliefs. Historically, some doctors took a paternalistic attitude to treatment following the ethical principle of beneficence’ - trying to judge the best interests of the patient in order to guide their clinical practice. This, however, is no longer accepted in our society and recently the issue of informed consent has been a matter of heated debate in medical journals and the subject of a set of guidelines from the General Medical Council (GMC).?
COUNSELLING CONSENT
AND INFORMATION
CONSENT
Consent in obstetric care is more complex than in any other field of medicine because of the possible consideration of two patients. Almost always, pregnant women wish the best for their fetus. However. in exceptional circumstances, a woman may choose to decline a course of action which medical evidence would strongly support. However bizarre her decision, assuming the mother is mentally competent, in the UK the mother’s rights are paramount. No procedure for the benefit of the fetus (or mother) can be performed without full maternal consent and this principle of autonomy is enshrined in law.’ In the case of a mentally incapacitated patient, the doctor must assess the patient’s ability to make an informed decision about the treatment. If a woman lacks the capacity to give consent but decides to comply with a treatment which is judged to be in her best interest, then a doctor can proceed. If, however, the patient does not comply or the treatment is controversial, approval by a court should be sort.? Initially, in counselling, information and options should be explained in a non-directive manner, but if a patient is still undecided, a counsellor should then again confirm that the woman understands all issues involved. However, it is not acceptable to give information and desert the patient to make up their own mind if they are struggling with the decision. If she is still undecided it can be reasonable to give advise and guidance, but this should only occur late in counselling process and with caution.
FOR
Accurate information forms the major part of any consent. Informed consent requires the patient to be fully aware of the nature of the test or procedure; including its aims, limitations, possible complications, success rates, the consequences of the results and alternative options. Having understood these, the patient must then make a decision to consent before undergoing the procedure. The GMC have clearly stated that the person obtaining consent must be suitably trained and qualified, and have sufficient knowledge of the proposed investigation or treatment to be able to obtain informed consent.? ‘Implied consent’ lmogen Montague MRCOG, Professor Peter Soothill MD MRCOG Fetal Medicine Research Unit. University of Bristol. St. Michael’s Hospital, Southwell Street, Bristol BSZ, UK Correspondence
IN OBSTETRICS
IO: F S.
170
Consent in prenatal diagnosis
Prc-screening
counsflliog
(Community)
171
Table 1 Patient information required for informed consent in prenatal diagnosis Nature of condition for which the diagnostic test is being offered Accuracy of the test Possible complications of the procedure Possible consequences of a positive result Possible false-positive or false-negative results
J, Clmwll J, Screening test Y
Y “High risk”
*Low risk”
+ Port screening counrelling JI
Y
Diagnostic lcsl
(Hospilnl wting IFMU)
Dcclinc
J, Abnormal
(llospilill setting)
Y rewlt
Normal
+ Cuunrclling
% Conocnt
(Dedicated FMU)
Y
c
+
Y
TOP
Fetal TX.
Intensive
Coosenalive
prcnntnl
ig. I
Mx.
(nature taku its count)
Pre-screening counselling
‘ONSENT IN PRENATAL
DIAGNOSIS
‘onsent should be an integral part of every prenatal iagnosis procedure.4 Many patients have strong per)nal. cultural. ethical and religious views which irect decision-making in pregnancy. Unfortunately, it :ems that women often proceed with investigations ffered without the knowledge required to give [formed consent.5 (Table 1). Although concerns have :en raised that full informed consent can be alarmlg to women.6 It appears that in other areas of medine, giving full details of possible consequences and )mplications as part of the consent process has been lown not to be psychologically harmful.’
ONSENT AND SCREENING IAGNOSIS
IN PRENATAL
xeening is an area in prenatal diagnosis in which formed consent has often been neglected and counmlling before any medical screening procedure is andatory.’ Counselling requires the patient to be vare of the nature of the condition being screened r, the accuracy of the screening test and the possible msequences of false-positive or false-negative sults. Surveys have shown that even the majority of
women undergoing serum screening for Down syndrome do not understand the limitations and inaccuracies of the test, and often the fault is in the information given. Ii As a rule, in the UK, counselling initially takes place in the primary health care setting. Studies have shown a poor understanding of screening procedures both by midwives and general practiti0ners.j With a change in working practices of midwives by rotating between hospital and community settings, we fear the problem of maintaining and updating the knowledge of those counselling for serum screening may grow. Continuing education of staff in how to provide clear information before any screening test is essential. Another major problem in the UK is that different health authorities have different screening policies.9.‘u Screening should be performed in an organized and supervised way and with standardized information agreed by health-care professionals involved in the service. The use of written information in the form of booklets has been shown to be only partly successful. The information contained is very variable in quality, and a significant proportion of women fail to read literature given to them at booking.” Recently, concern has been raised following a screening procedure being performed without patient consent’? and indeed to apply a screening test to an individual without consent would be unethical. This principle applies to both ‘opt-in or opt-out’ screening programmes because the argument that to improve the uptake (and so the success) of a screening programme by making it ‘opt out’ is, therefore, wrong since every woman should both understand and consent (and, therefore, opt-in) before any test is done (Fig. 1).
CONSENT AND SCANNING DIAGNOSIS
IN PRENATAL
Ultrasound scanning is now an essential component of normal obstetric care, but its use at any stage of pregnancy has the potential to diagnose a fetal abnormality if present. Most women attending for routine scanning are at low risk of a fetal abnormality and the scan is for them the first opportunity to ‘see’ their baby. Indeed, many appear unaware that one of the aims of a scan may be to diagnose a fetal abnormality.13 A consequence of this is that parents are often poorly prepared for bad news or possible uncertainty of normality. Before any scanning the patient should
172
Current Obstetrics & Gynaecology
be made aware of the purpose of the scan, the possibility of a problem being detected arId the degree of uncertainty with scan diagnosis. Such pre-scan counselling should constitute a routine part of antenatal care. Even with informed choice, the uptake of ultrasound anomaly screening seems to be markedly above that which would be expected for other prenatal screening tests and this uptake has been attributed to the overwhelming desire to ‘see the baby’.lJ
positive outcomes. Even in the presence of fetal abnormalities, the parents can be prepared for the possible outcomes and management options, and allow them to meet during the pregnancy the teams which will be involved after delivery. However, these benefits from prenatal diagnosis have, as yet, not been objectively measured or assessed scientifically.
CONCLUSION SELECTIVE
CONSENT
IN SCANNING
A few women will not want to know when an abnormality is suspected at a routine scan. However, once a problem has been identified this information cannot be withheld from the parents unless this has been discussed and agreed beforehand. It is important to realise that in such cases, a woman might chose to opt out of the ‘anomaly’ aspect of a scan, but still benefit from accurate dating, placental localization and viability assessment.ls
CONSENT
FOR INVASIVE
FETAL TESTING
Women identified as being of higher risk from past history or screening may often have more time to consider their options but they should have detailed counselling before undergoing any invasive test. Such counselling should take place in a hospital setting, by a specialist and usually in a defined fetal medicine unit. Careful informed consent is a major part of fetal-medicine practice. It is possible that clinicians who do not have a special interest may be unaware of certain rare consequences of a procedure, such as failed cytogenetic culture, confined placental mosacism or maternal contamination. Best practice which includes continuous ultrasound visualization of the needle throughout any invasive test is still not used by some obstetricians and this practice should be actively discouraged.
OTHER POSSIBLE BENEFITS PRENATAL TESTING
FROM
Counselling for consent in prenatal diagnosis should include the important information that termination of a pregnancy with a severe fetal abnormality is only one objective of diagnosis. ‘6~‘7The ability to optimize appropriate antenatal surveillance fetal therapy, timing of delivery and the option to deliver in units with paediatric surgical facilities if appropriate are other
Informed consent is an essential component of every aspect of prenatal diagnosis.18 In both screening and routine scan assessment, counselling and consent should be obtained before any investigation. REFERENCES I.
Chervenak E McCullough L. Ethics, an emerging subdiscipline of obstetric ultrasound, and its relevance to the routine obstetric scan Ultra. Obstet Gynecol 1991; I: IS-20 GMC. Seeking patient’s consent: the ethical considerations 1999. London: General Medical Council MB (I 117) 2 FCR 541. 38 BMLR 175 Marteau TM Towards informed decisions about prenatal testing: a review. Prenat Diagn 1995; I5( 13): 1215-1226 Gekas J. Gondry J, Mazur S, Cesborn P. Thepot F, Informed consent to serum screening for Down’s syndrome: are women given adequate information? Prenat Diagn 1999; 19: I-7 6. Oliver S, Rajan L, Turner H et al. Informed choice for users of health services: views on ultrasonography leaflets of women in early pregnancy. midwives and ultrasonographers. BMJ 1996; 313: 1251-1253 I. Keerigan D, Thavasagayam R, Woods T et al. Who’s afraid of informed consent? BMJ 1993: 306: 298-300 8. Sadler M. Serum screening for Down’s syndrome: how much do health professionals know? Br J Obstet Gynaecol 1997: 104: 176179 9. Dormandy E. Better understanding of factors influencing uptake is needed BMJ. 1998; 3 IS: 805 IO. Dodds R. The stress of tests in pregnancy: summary of a National Childbirth Trust antenatal screening survey. London: National Childbirth Trust. 1997 II. Marteau TM, Slack J. Kidd J, Shaw RW. Presenting a routine screening test in antenatal care: practice observed. Public Health 1992; 106: 131-141 12. Venn-Treloar J. Nuchal translucency - screening without consent. BMJ 1998: 316: 1027 13. Proud J, Murphy-Black T. Choice of a scan: how much information do women receive before ultrasound. Br J Midwifery 1997; I: 144-147 14. Baillie C, Mason G. The psychological impact of obstetric ultrasound scans and soft marker screening. Imaging 1997; 9: 115-122 15. Ballie C, Hewison J. Obtaining selective consent to scanning, rather than screening, is possible BMJ 1999: 318: 805 16. Royal College of Obstetricians and Gynaecologists study group. Statistical aspects of screening for Downs Syndrome. In: Grudzinskas JG, Ward RHT (eds.) Screening for Down syndrome in the tirst trimester. London: RCOG Press, 1997 17. Carroll S. Measurements give parents useful information BMJ 1998; 317: 748 18. McFadyen A, Gledhill J. Whitlow B. Economides D. First trimester ultrasound screening. BMJ 1998; 317: 694695