Public reporting of clinical outcomes in assisted reproductive technology

10 07 2013

To the Editor:

We read the article “The status of public reporting of clinical outcomes in assisted reproductive technology” by Kushnir et al. (1) with great interest. As stewards of the National ART Surveillance System (NASS), we are always striving to improve data collection and public reporting of clinical outcomes of ART, as required by the Fertility Clinic Success Rates and Certification Act (FCSRCA) of 1992. The article refers to a recent but increasing trend of short-term embryo banking (cycles in which all embryos are created with the intent of cryopreservation for subsequent transfer in frozen/thawed cycle(s) in the next few months) following advances in cryopreservation techniques (2). Some of the potential reasons to delay embryo transfer include: embryo accumulation from several short-term embryo banking cycles to allow better choice of good-quality embryos, desire to avoid potentially negative effects of stimulation on implantation/pregnancy rates and fetal development, and need to wait for the results of preimplantation genetic screening. In contrast, long-term embryo banking cycles are generally used for fertility preservation for patients undergoing gonadotoxic medical treatments or for those who wish to delay childbearing for other reasons. Although NASS is currently unable to distinguish between short- and long-term banking cycles, we note that the total number and percent of embryo banking cycles in the U.S. has increased dramatically during recent years (Figure).

Click for larger view
Click for larger view

Since FCSRCA requires public reporting of ART success rates, embryo banking cycles (which by definition do not result in clinical outcome) are not shown in the national or clinic-specific pregnancy success rates tables. However, all embryo banking cycles fit the definition of ART and are required to be reported to the Centers for Disease Control and Prevention (CDC). Thus, we believe that the authors incorrectly assumed that embryo banking cycles are “unreported” or “excluded” by clinics. The outcomes of all frozen/thawed embryo transfers have been publicly reported for cycles started during or after 1995, the first year national ART surveillance began. In addition, reporting of embryo banking cycles is validated annually (3).

We agree that with recent increases in embryo banking cycles, concurrent changes in information provided to consumers are warranted. For that reason, the 2011 ART Fertility Clinic Success Rates Report will include the number of embryo banking cycles. Ideally, the outcomes of embryo banking cycles would be reported both per cycle and per transfer, and separately for short-term and long-term embryo banking. This approach, however, requires collection of additional information on cycle intent and/or linkage between embryo banking cycle(s) and subsequent frozen/thawed embryo transfer cycle(s), which often occur in different reporting years. Reporting the number of cycles using frozen/thawed embryos from previous transfer cycles and the numbers of short-term and long-term embryo banking cycles will inform potential ART consumers about differences in clinical practices and outcomes.

Public reporting of clinical outcomes of ART has been providing useful information for ART providers, patients, researchers, and the general public during the last 16 years (4). The use of NASS data contributed to improvements in the field, and made studies like the one by Kushnir et al. possible. That study serves as a reminder that reporting of clinical outcomes of ART needs to keep pace with rapidly changing clinical practice. We are considering revisions to the NASS data collection to better assess new methods and technologies and include some of the measures described above.

Dmitry Kissin, M.D., M.P.H., Sara Crawford, Ph.D., Sheree Boulet, Dr.P.H., M.P.H.,
National ART Surveillance System (NASS) Group (www.cdc.gov/art)

Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

References

1. Kushnir VA, Vidali A, Barad DH, Gleicher N. The status of public reporting of clinical outcomes in assisted reproductive technology. Fertil Steril. 2013 [Epub ahead of print]

2. Gobsen R. Cryopreservation: a cold look at technology for fertility preservation. Fertil Steril. 2011; 96:264-8.

3. Centers for Disease Control and Prevention, American Society for Reproductive Medicine, Society for Assisted Reproductive Technology. 2010 Assisted Reproductive Technology National Summary Report, Atlanta: U.S. Department of Health and Human Services; 2012.

4. Adashi EY, Wyden R. Public reporting of clinical outcomes of assisted reproductive technology programs: implications for other medical and surgical procedures. JAMA. 2011;306:1135-6.

Published online in Fertility and Sterility doi:10.1016/j.fertnstert.2013.07.199

The authors respond:

We appreciate the interest of Kissin et al. from the National ART Surveillance System (NASS) group at the Centers for Disease Control and Prevention (CDC) in our recent manuscript (1). Our manuscript apparently also prompted a communication from the president of the Society for Assisted Reproductive Technology (SART) to member clinics, acknowledging the issues we raised with public ART surveillance, and promising to find a solution to improve transparency of future reports.

Both of these communications confirm that a rapidly growing number of initiated IVF cycles with no reported outcomes are being categorized as embryo banking. The NASS team, furthermore, highlights the ever-growing number of indications for embryo banking. One cannot help but wonder whether the “observer effect,” and resulting competition among ART clinics to achieve superior pregnancy outcomes, may actually incentivize diversion of less favorable prognosis patients into embryo banking. Our findings suggest that selective embryo banking for older patients (that is, unfavorable cycles) improved reported pregnancy rates and increased market share in clinics disproportionately practicing embryo banking.

The NASS letter suggests that we may incorrectly assume that clinics consciously choose to exclude cycles. Our study, however, suggests the opposite: we demonstrate that an overwhelming majority of clinics, based on a statistical distribution curve, report data accurately, and within the intended framework allowed by SART and CDC. A small minority, however, clearly fall outside the norm and report excluded cycles that disproportionately involve older patients. Whether this happens with or without intent matters little because the consequence of such misleading reporting is the same: clinical pregnancy rates are artificially inflated, and the public is misled. Outdated reporting algorithms of SART and CDC undoubtedly contribute to the current situation, as the NASS letter and the call to action by SART appear to acknowledge. This, however, does not absolve centers from responsible reporting. It does not take extraordinary statistical expertise to recognize that a program’s pregnancy outcomes will be artificially inflated if worst prognosis patients are routinely excluded from consideration.

Since frozen/thawed cycles are only reported per transfer, cycles are effectively excluded from outcome statistics by both SART and CDC if no embryos survive thawing. This strengthens our conclusions that a significant portion of patients relegated to embryo banking may not reach transfer in subsequent thaw cycles.

We are encouraged by the acknowledgment of leadership at CDC and SART that the transparency of ART outcome reporting has to be improved to better serve the public. At the same time, we are disappointed that a small number of clinics, knowingly or unknowingly, have taken advantage of shortcomings of the current reporting system. Even the most sophisticated reporting system can be abused. As a large majority of reporting ART clinics demonstrated, however, just because a system lends itself to abuse, does not mean that one has to take advantage of the opportunity.
Because current ART reporting was recently proposed as a potential example for other surgical outcome reports (2), our report should also be viewed as potential warning on a larger scale. If the public is to benefit from such national outcome reports, their integrity needs to be ensured both by the designers and physicians who use them.

Vitaly A. Kushnir, M.D., Andrea Vidali, M.D., David H. Barad, M.D., M.S., Norbert Gleicher, M.D.
The Center for Human Reproduction (V.A.K, D.H.B., N.G.)
New York Reproductive Services (A.V.)
The Foundation for Reproductive Medicine (D.H.B., N.G.)
New York, New York

References

1. Kushnir VA, Vidali A, Barad DH, Gleicher N. The status of public reporting of clinical outcomes in assisted reproductive technology. Fertil Steril. 2013 [Epub ahead of print]

2. Adashi EY, Wyden R. Public reporting of clinical outcomes of assisted reproductive technology programs: implications for other medical and surgical procedures. JAMA. 2011;306:1135-6.

Published online in Fertility and Sterility doi:10.1016/j.fertnstert.2013.07.198

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12 07 2013
CHR paper on manipulation of SART outcome reporting stirs up debate » CHR Blog :: Center for Human Reproduction

[…] at the Center for Disease Control (CDC) responsible for the outcome reporting recently published a response to the CHR paper. In their response, the National ART Surveillance System (NASS) group, led by Dr. […]

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