| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
|
|
|
|||||||
|
|||||||||
ORIGINAL RESEARCH |
From the Department of Obstetrics and Gynecology, University of Washington, Seattle, Washington; and the Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Medicine and Dentistry of New Jersey–Robert Wood Johnson Medical School, New Brunswick, New Jersey.
Address reprint requests to: David B. Seifer, MD Department of Obstetrics, Gynecology, and Reproductive Sciences UMDNJ-Robert Wood Johnson Medical School 303 George Street, Suite 250 New Brunswick, NJ 08901 E-mail: seiferdb{at}umdnj.edu
 |
Abstract |
|---|
Top
 Abstract Materials and MethodsResultsDiscussionReferences |
|---|
Methods: Board-certified reproductive endocrinologists (n = 575) were surveyed by mail regarding how they informed patients and obtained consent for infertility treatments and how their practices had been influenced by studies suggesting a link between ovulation induction and ovarian cancer. Data were analyzed using 
2 and logistic regression analyses.
Results: The return rate was 62.1% (357 of 575 surveys). Most respondents (92%) used discussions with physicians to inform their patients of risks and benefits of all infertility treatments. Additional means, such as audiovisual aids, were used significantly more often for assisted reproductive technologies (including intracytoplasmic sperm injection and use of donated eggs) than for less invasive therapies (31–43% versus 4–11%, P < .001). Most physicians (46–66%) used verbal consent alone for hysterosalpingogram, intrauterine insemination, and ovulation induction. Formal written consent was used significantly more often for the various assisted reproductive technologies than for hysterosalpingogram, intrauterine insemination, or ovulation induction (94–95% versus 26–44%). Although most physicians (70%) did not believe that ovulation induction increases the risk of ovarian cancer, 83% addressed this risk when obtaining consent and 47% reported changing their practices since an association was reported. Common changes included limiting length of treatment and addressing ovarian cancer risk.
Conclusion: Current practice patterns of obtaining informed consent for various infertility treatments by board-certified reproductive endocrinologists show, as expected, that informed consent is more rigorous for assisted reproductive technologies. Although most surveyed did not believe that ovulation induction increases risk of ovarian cancer, the majority of physicians addressed that risk when obtaining consent and nearly half changed their practices on the basis of a possible association.
The practice of infertility treatment has expanded rapidly over the past several decades, spurred by the introduction of assisted reproductive technologies and improvements in ovulation induction. Over the same period, informed consent for medical treatment has been established as standard procedure. In 1992, the ACOG Committee on Ethics defined two components of informed consent: free consent and comprehension.1 Free consent means voluntary authorization of another to act in defined ways. Comprehension means awareness and understanding of the medical situation and the effects of possible treatments. Thus, comprehension requires physicians to give adequate information to patients. ACOG1 put forth three possible criteria for adequate disclosure: common practice of the profession, reasonable needs and expectations of ordinary people who might be deciding, and unique needs of a patient faced with a choice. The standard-of-care criterion has been used primarily, because it is easier to define legally.
The need for proper informed consent is greater in infertility treatment because unlike treatments for sick or injured patients, infertility treatments often require healthy patients to take significant risks, such as multiple pregnancies, ovarian hyperstimulation, and procedural injuries, as well as emotional and financial risks. With expanding therapeutic options for infertile couples, it is important to define standard of care in obtaining informed consent for various infertility procedures. Recent controversial reports that suggest increased risks of ovarian neoplasms in women who had ovulation induction have made this need greater.2,3 Although the relationship between ovarian cancer and ovulation induction has been questioned,4–7 the influence of that association on informed consent for infertility treatment is unknown.
The objectives of this study were to determine current practice patterns of obtaining informed consent for infertility treatments by board-certified reproductive endocrinologists practicing in the United States and Canada and to assess changes in practice patterns in response to recent studies reporting an association between ovulation induction and ovarian cancer.
|
Materials and Methods |
|---|
|
Top
AbstractMaterials and MethodsResultsDiscussionReferences |
|---|
The questionnaire, composed of 11 questions, was designed to take less than 5 minutes to complete. No response was identified by name, to ensure anonymity. Respondents were asked separately how they informed patients and how they obtained consent for various procedures, including hysterosalpingogram, endometrial sampling, intrauterine insemination, ovulation induction with clomiphene citrate and gonadotropins, assisted reproductive technologies (egg retrieval, gamete and zygote intrafallopian transfer), intracytoplasmic sperm injection, and use of donated eggs. Physicians were asked which of the following were used to inform their patients of risks, benefits, and alternatives to recommended therapies: verbal discussion with a physician, verbal discussion with other office staff, or written materials or audiovisual aids. Respondents could indicate that none of those were used or that they did not practice a specific procedure. Physicians were asked to select the primary type of consent obtained for each of the procedures given earlier. The options were verbal consent, with documentation in the chart; formal written consent; and neither. Formal written consent implies a verbal discussion with the patient; therefore, for summary purposes, an answer of both verbal consent and formal written consent was considered to mean formal written consent. Respondents then were asked whether they addressed various risks of ovulation induction and assisted reproductive technologies when obtaining consent. Finally, physicians were asked whether they believed that ovulation induction increases a woman’s risk of ovarian cancer. They also were asked whether their practices had been changed by studies suggesting a link between ovulation induction and ovarian cancer, and if so, how. Demographic information was obtained through the survey, including geographic location, city size, type of practice (community- or university-based), number of partners, and year of board certification in reproductive endocrinology.
Rates of survey return and rates of use of various means of informing patients and obtaining consent were calculated in percentage format. Associations among demographic information and between demographics and outcome variables were analyzed using 2 and logistic regression analyses.
|
Results |
|---|
|
Top
AbstractMaterials and MethodsResultsDiscussionReferences |
|---|
. Because the number of respondents from Puerto Rico and Canada was small, these surveys were excluded from analyses involving location, but they were included in all other analyses. Several associations among the demographic variables were noted. Predominant city size varied significantly with geographic location. More respondents from the southern United States practiced in medium-sized cities (population 50,000–500,000), compared with those from the northeastern and midwestern United States (55 versus 35 and 33%, respectively; P < .01). In the western United States, an increased number of respondents (79%) practiced in large cities (population over 500,000). Practice type varied significantly with year of board certification in reproductive endocrinology. Compared with physicians certified during other periods, a higher percentage of reproductive endocrinologists certified between 1981 and 1985 practiced in the community setting (61 versus 37–42%, P < .05).
|
. More than 92% of all respondents used discussions with physicians as primary means for informing patients about procedures. Additional means, such as audiovisual aids, were used significantly more often for assisted reproductive technologies than for hysterosalpingogram, endometrial sampling, intrauterine insemination, or ovulation induction with clomiphene citrate (31–43 versus 4–11%, P < .001). The patterns were similar for discussions with office staff and written materials, with increased use of those for assisted reproductive technologies, compared with hysterosalpingogram, endometrial sampling, intrauterine insemination, and ovulation induction with clomiphene citrate. The use of those means for informing patients was not influenced significantly by the demographics of the respondents, as examined by logistic regression analyses.
|
). Use of verbal consent alone was significantly less for assisted reproductive technologies, compared with hysterosalpingogram, endometrial sampling, intrauterine insemination, and ovulation induction with clomiphene citrate or gonadotropins (less than 6 versus 46–66%; P < .001). Formal written consent was used for more advanced technologies by 94–95% of respondents. Compared with their university-based colleagues, a higher percentage of community-based physicians used formal written consent for ovulation induction with clomiphene (34 versus 20%, P < .05) and with gonadotropins (52 versus 38%, P < .05).
|
. The likelihood of discussion of various risks was influenced by several demographic variables. Compared with physicians based at universities, a higher percentage of community-based physicians counseled about ovarian cancer (89 versus 81%, P < .05), preterm delivery in singleton pregnancies (45 versus 30%, P < .01), financial costs (85 versus 76%, P < .05), and success rates (84 versus 75%, P < .05). Year of certification significantly influenced counseling about preterm delivery in singleton pregnancies. A significantly (P < .01) higher percentage of physicians certified before 1981 (55%) discussed this risk, compared with those certified between 1981 and 1985 (40%), between 1986 and 1990 (38%), and in 1991 or later (25%).
|
|
Discussion |
|---|
|
Top
AbstractMaterials and MethodsResultsDiscussionReferences |
|---|
The obtaining of informed consent was not found to be influenced significantly by geographic location, city size, or number of partners in practices. Year of board certification in reproductive endocrinology and practice type did influence discussion of risks of ovulation induction. The reasons that community-based physicians would be more likely to counsel about ovarian cancer risk, preterm delivery in singleton pregnancies, financial costs, and success rates are unclear. Nearly 83% of respondents to our survey counsel patients about the risks of ovarian cancer after ovulation induction, but only 47% reported changes in their practice patterns since this association was reported. The reason for this inconsistency is not clear. Perhaps some respondents had been counseling their patients about this theoretical risk before the epidemiologic association was reported, or perhaps some respondents failed to realize that their practices had been influenced in some way by those studies.
Recent studies and analyses4–7 have tempered the initial concern2,3 regarding ovarian cancer risk after infertility treatment. However, the association between ovulation induction and ovarian cancer remains theoretically plausible and is still defined incompletely. The present study shows that the majority of reproductive endocrinologists remain skeptical of a causal relationship between ovulation induction and ovarian cancer. However, nearly half of these physicians changed some aspect of their practices on the basis of the reported association. Those beliefs and the propensity to change were influenced by year of board certification. According to the present survey, informing patients of the uncertain association between ovulation induction and ovarian cancer risk is common. Many reproductive endocrinologists also have begun to limit more strictly the length of treatment with infertility medications (typically to no more than 12 cycles).
The importance of counseling in this area was emphasized by a recent study8 that examined women’s perceptions of risks and benefits of fertility drug therapy in relation to ovarian cancer risk. The majority of women surveyed were willing to accept a two- to ten-fold increase in their lifetime risk of ovarian cancer. However, most of them did not appear to have an accurate perception of survival and cure rates for ovarian cancer. Only 24% of the women surveyed understood that ovarian cancer was usually not curable. Thus, it is physicians’ responsibility to inform patients about the risks of therapy and the possible consequences of those risks.
A recent abstract (Thomas J, Neuman J, Shapiro HM, Rosen B, Robinson GE, Murphy JK, et al. Ovulation induction drugs and an increased risk of ovarian cancer: Determinants of practice change. Program of the American Society for Reproductive Medicine, 1997: Abstract P-164; S171) described a similar survey of changes in practice patterns in response to literature on ovarian cancer risk. However, that study population differed significantly from the present study population. Thomas and colleagues (Program of the American Society for Reproductive Medicine, 1997: Abstract P-164; S171) surveyed English-speaking Canadians practicing obstetrics and gynecology. The majority (about 80%) devoted less than 25% of their practices to infertility treatment, unlike our survey population of physicians who were American board-certified in reproductive endocrinology and infertility. Despite those differences, some similar findings emerged. Thomas et al (Program of the American Society for Reproductive Medicine, 1997: Abstract P-164; S171) found that 40% of physicians discuss ovarian cancer risk before prescribing fertility medications and that most had begun to do so only recently. Other changes in practice patterns included limiting the number of treatment cycles, treating women with family histories of ovarian cancer less often, and treating more willingly those women who had used OCs. Physicians who changed their practice patterns were more likely to be familiar with the relevant literature. They also were more likely to have used gonadotropin therapy in their practices. A strength of the current study is that it provides standard-of-care basis for informed consent from physicians with advanced training in infertility treatment and certification by the American Board of Obstetrics and Gynecology.
Another controversial risk of assisted reproductive technologies is preterm deliveries of singleton fetuses. Early studies of outcomes of pregnancies resulting from use of assisted reproductive technologies found higher rates of preterm deliveries, even for singleton pregnancies.9–13 Other studies,14,15 including a recent cohort study with controls matched for age, parity, ethnic origin, location, and date of delivery,16 failed to show increased risk of preterm deliveries in singleton pregnancies resulting from in vitro fertilization. Our study found that about one-third of reproductive endocrinologists counsel their patients about risks of preterm deliveries in singleton pregnancies. A higher percentage of physicians certified before 1981 discuss this risk. Perhaps these physicians are more influenced by the early literature describing the association.
Although the return rate of 62% in this study is better than the rate of 30–50% that is common in studies that rely on mailed surveys,17,18 the possibility of sampling bias still exists. Because of limitations imposed by ensuring complete anonymity of the respondents, it is not possible to be certain that the practice of obtaining informed consent for infertility treatment is identical in the nonresponding group. However, this study provides a basis for further study of the process of obtaining informed consent in infertility treatment.
|
Footnotes |
|---|
Supported in part by grant from NIH-NIA R29AG15425 (DBS).
Received May 12, 1998. Received in revised form August 6, 1998. Accepted August 20, 1998.
|
References |
|---|
|
Top
AbstractMaterials and MethodsResultsDiscussionReferences |
|---|
2. Whittemore AS, Harris R, Itnyre J, the Collaborative Ovarian Cancer Group. Characteristics relating to ovarian cancer risk: Collaborative analysis of 12 US case-control studies. Am J Epidemiol 1992;136:1184–203.
3. Rossing MA, Daling JR, Weiss NS, Moore DE, Self SG. Ovarian tumors in a cohort of infertile women. N Engl J Med 1994;331: 771–6.
4. Ron E, Lunfeld B, Menczer J, Blumstein T, Katz L, Oelsner G, et al. Cancer incidence in a cohort of infertile women. Am J Epidemiol 1987;125:780–90.
5. Venn A, Watson L, Lumley J, Giles G, King C, Healy D. Breast and ovarian cancer incidence after infertility and in vitro fertilisation. Lancet 1995;346:995–1000.[Medline]
6. Bristow RE, Karlan BY. Ovulation induction, infertility, and ovarian cancer risk. Fertil Steril 1996;66:499–507.[Medline]
7. Mosgaard BJ, Lidegaard O, Kjaer SK, Schou G, Andersen AN. Infertility, fertility drugs, and invasive ovarian cancer: A case-control study. Fertil Steril 1997;67:1005–12.[Medline]
8. Rosen B, Irvine J, Ritvo P, Shapiro H, Stewart D, Reynolds K, et al. The feasibility of assessing women’s perceptions of the risks and benefits of fertility drug therapy in relation to ovarian cancer risk. Fertil Steril 1997;68:90–4.[Medline]
9. High incidence of preterm births and early losses in pregnancy after in vitro fertilisation. Australian in vitro fertilisation collaborative group. BMJ 1985;291:1160–3.
10. Tan SL, Doyle P, Campbell S, Beral V, Rizk B, Brinsden P, et al. Obstetric outcome of in vitro fertilization pregnancies compared with normally conceived pregnancies. Am J Obstet Gynecol 1992; 167:778–84.[Medline]
11. Doyle P, Beral V, Maconochie N. Preterm deliveries, low birth weight and small-for-gestational-age in liveborn singleton babies resulting from IVF. Hum Reprod 1992;7:425–8.
12. Wang JX, Clark AM, Kirby CA, Philipson G, Petrucco O, Anderson G, et al. The obstetric outcome of singleton pregnancies following in-vitro fertilization/gamete intrafallopian transfer. Hum Reprod 1994;9:141–6.
13. Rufat P, Olivennes F, Mouzon J, Dehan M, Frydman R. Task force report on the outcome of pregnancies and children conceived by in vitro fertilization (France 1987 to 1989). Fertil Steril 1994;61:324–30.[Medline]
14. Frydman R, Belaisch-Allart J, Fries N, Hazout A, Glissant A, Testart J. An obstetric assessment of the first 100 births from the in vitro fertilization program at Clamart, France. Am J Obstet Gynecol 1986;154:550–5.[Medline]
15. Hill GA, Bryan S, Herbert CM III, Shah DM, Wentz AC. Complications of pregnancy in infertile couples: Routine treatment versus assisted reproduction. Obstet Gynecol 1990;75:790–4.
16. Reubinoff BE, Samueloff A, Ben-Haim M, Friedler S, Schenker JG, Lewin A. Is the obstetric outcome of in vitro fertilized singleton gestations different from natural ones? A controlled study. Fertil Steril 1997;67:1077–83.[Medline]
17. Drane JW. Imputing nonresponses to mail-back questionnaires. Am J Epidemiol 1991;134:908–12.
18. Sandlow JI, Kreder KJ. A change in practice: Current urologic practice in response to reports concerning vasectomy and prostate cancer. Fertil Steril 1996;66:281–4.[Medline]
This article has been cited by other articles:
|
|
 |
|
  D. L. Hock, D. B. Seifer, E. Kontopoulos, and C. V. Ananth Practice Patterns Among Board-Certified Reproductive Endocrinologists Regarding High-Order Multiple Gestations: A United States National Survey Obstet. Gynecol., May 1, 2002; 99(5): 763 - 770. [Abstract] [Full Text] [PDF]
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
