Effect of a Patient-Centered Decision Support Tool on Rates of Trial of Labor After Previous Cesarean Delivery : The PROCEED Randomized Clinical Trial

Background The original version of the International Patient Decision Aid Standards (IPDAS) recommended that patient decision aids (PtDAs) should be carefully developed, user-tested and open to scrutiny, with a well-documented and systematically applied development process. We carried out a review to check the relevance and scope of this quality dimension and, if necessary, to update it. Methods Our review drew on three sources: a) published papers describing PtDAs evaluated in randomised controlled trials and included in the most recent Cochrane Collaboration review; b) linked papers cited in the trial reports that described how the PtDAs had been developed; and c) papers and web reports outlining the development process used by organisations experienced in developing multiple PtDAs. We then developed an extended model of the development process indicating the various steps on which documentation is required, as well as a checklist to assess the frequency with which each of the elements was publicly reported. Results Key features common to all patient decision aid (PtDA) development processes include: scoping and design; development of a prototype; ‘alpha’ testing with patients and clinicians in an iterative process; ‘beta’ testing in ‘real life’ conditions (field tests); and production of a final version for use and/or further evaluation. Only about half of the published reports on the development of PtDAs that we reviewed appear to have been field tested with patients, and even fewer had been reviewed or tested by clinicians not involved in the development process. Very few described a distribution strategy, and surprisingly few (17%) described a method for reviewing and synthesizing the clinical evidence. We describe a model development process that includes all the original elements of the original IPDAS criterion, expanded to include consideration of format and distribution plans as well as prototype development. Conclusions The case for including each of the elements outlined in our model development process is pragmatic rather than evidence-based. Optimal methods for ensuring that each stage of the process is carried out effectively require further development and testing.

Trial of labor after cesarean delivery (TOLAC) refers to a planned attempt to deliver vaginally by a woman who has had a previous cesarean delivery, regardless of the outcome. This method provides women who desire a vaginal delivery the possibility of achieving that goal-a vaginal birth after cesarean delivery (VBAC). In addition to fulfilling a patient's preference for vaginal delivery, at an individual level, VBAC is associated with decreased maternal morbidity and a decreased risk of complications in future pregnancies as well as a decrease in the overall cesarean delivery rate at the population level (). However, although TOLAC is appropriate for many women, several factors increase the likelihood of a failed trial of labor, which in turn is associated with increased maternal and perinatal morbidity when compared with a successful trial of labor (ie, VBAC) and elective repeat cesarean delivery (). Therefore, assessing the likelihood of VBAC as well as the individual risks is important when determining who is an appropriate candidate for TOLAC. Thus, the purpose of this document is to review the risks and benefits of TOLAC in various clinical situations and to provide practical guidelines for counseling and management of patients who will attempt to give birth vaginally after a previous cesarean delivery.