September 28, 2020
National Center for Health Research’s Comments on the Agency for Healthcare Research and Quality’s Draft Systematic Review Regarding Cervical Ripening in the Outpatient Setting
We are writing to express our views on the Agency for Healthcare Research and Quality’s (AHRQ) draft systematic review regarding the comparative effectiveness and potential harms of cervical ripening in the outpatient versus the inpatient setting.
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
We support the review’s examination of the relative risks and outcomes of outpatient interventions compared to the inpatient setting. We agree that due to the small sample sizes of many of the studies, it is not possible to assess rare outcomes. Additionally, the women in the studies were mostly young and white with few pre-existing health conditions. For this reason, the findings should not be considered generalizable; they are only applicable to a limited group of women. We recommend caution against generalizing, and encourage that future studies are not only larger, but have a more inclusive sample.
However, an overarching problem in the review is that it does not examine the role of patient-centered outcomes and satisfaction. Like harms and risks, these factors can impact patients’ decision-making regarding inpatient versus outpatient cervical ripening. The review concludes that there is no medical difference in outcomes for cervical ripening in the inpatient or outpatient setting, but it fails to account for the subjective experiences of the patients. The outcomes for either method may not feel equal for patients, in the short or long-term.
Forty percent of the studies in the review were not in the United States. Depending on the health care system, insurance coverage, and procedure affordability, patients’ experiences may vary significantly between countries. The review would therefore be more informative if it separately reviewed studies in the U.S. and other countries. We also note the need for studies on long-term outcomes such as breastfeeding, mother and baby health and mood, and mother-baby attachment.
The AHRQ review notes that the limitations of the research that has been conducted leads to limitations of their review. We agree. Although they found no difference in outcomes for inpatient and outpatient procedures, we have no confidence that the results would be similar if the studies were larger, had more diversity of the patients, assessed outcomes of greatest importance to patients, and separately analyzed for U.S. patients, since the U.S. healthcare system is so different from most other countries.