Development and Validation of a Model for Opioid Prescribing Following Gynecological Surgery.
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2022-07
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Abstract
Importance
Overprescription of opioid medications following surgery is well documented. Current prescribing models have been proposed in narrow patient populations, which limits their generalizability.Objective
To develop and validate a model for predicting outpatient opioid use following a range of gynecological surgical procedures.Design, setting, and participants
In this prognostic study, statistical models were explored using data from a training cohort of participants undergoing gynecological surgery for benign and malignant indications enrolled prospectively at a single institution's academic gynecologic oncology practice from February 2018 to March 2019 (cohort 1) and considering 39 candidate predictors of opioid use. Final models were internally validated using a separate testing cohort enrolled from May 2019 to February 2020 (cohort 2). The best final model was updated by combining cohorts, and an online calculator was created. Data analysis was performed from March to May 2020.Exposures
Participants completed a preoperative survey and weekly postoperative assessments (up to 6 weeks) following gynecological surgery. Pain management was at the discretion of clinical practitioners.Main outcomes and measures
The response variable used in model development was number of pills used postoperatively, and the primary outcome was model performance using ordinal concordance and Brier score.Results
Data from 382 female adult participants (mean age, 56 years; range, 18-87 years) undergoing gynecological surgery (minimally invasive procedures, 158 patients [73%] in cohort 1 and 118 patients [71%] in cohort 2; open surgical procedures, 58 patients [27%] in cohort 1 and 48 patients [29%] in cohort 2) were included in model development. One hundred forty-seven patients (38%) used 0 pills after hospital discharge, and the mean (SD) number of pills used was 7 (10) (median [IQR], 3 [0-10] pills). The model used 7 predictors: age, educational attainment, smoking history, anticipated pain medication use, anxiety regarding surgery, operative time, and preoperative pregabalin administration. The ordinal concordance was 0.65 (95% CI, 0.62-0.68) for predicting 5 or more pills (Brier score, 0.22), 0.65 (95% CI, 0.62-0.68) for predicting 10 or more pills (Brier score, 0.18), and 0.65 (95% CI, 0.62-0.68) for predicting 15 or more pills (Brier score, 0.14).Conclusions and relevance
This model provides individualized estimates of outpatient opioid use following a range of gynecological surgical procedures for benign and malignant indications with all model inputs available at the time of procedure closing. Implementation of this model into the clinical setting is currently ongoing, with plans for additional validation in other surgical populations.Type
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Rodriguez, Isabel V, Paige McKeithan Cisa, Karen Monuszko, Julia Salinaro, Ashraf S Habib, J Eric Jelovsek, Laura J Havrilesky, Brittany Davidson, et al. (2022). Development and Validation of a Model for Opioid Prescribing Following Gynecological Surgery. JAMA network open, 5(7). p. e2222973. 10.1001/jamanetworkopen.2022.22973 Retrieved from https://hdl.handle.net/10161/27477.
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Scholars@Duke
Ashraf Samir Habib
Ashraf Habib is a Professor of Anesthesiology, Professor in Obstetrics and Gynecology and Chief of the Division of Women’s Anaesthesia at Duke University Medical Center. He received his medical degree from Ain Shams University in Cairo, Egypt. He completed his anesthetic training in the UK, subsequently finished fellowship training in Obstetric Anesthesia at Duke University Medical Center and stayed there as faculty. He has published over 250 peer-reviewed manuscripts, book chapters and editorials. His research interests include enhanced recovery after surgery including cesarean delivery, optimizing labor analgesia and postoperative outcomes such as postoperative pain and postoperative nausea and vomiting, persistent pain after surgery and optimizing hemodynamic management of women undergoing caesarean delivery. Dr. Habib is currently a senior Editor for Anesthesia and Analgesia and is on the Editorial Board of the International Journal of Obstetric Anesthesia and BJA Education. He has also been a member of the expert panel that generated the ASER/SAMBA consensus guidelines for the management of postoperative nausea and vomiting, the Society for Obstetric Anesthesia and Perinatology (SOAP) consensus statement and recommendations for enhanced recovery after cesarean delivery, the SOAP consensus statement for respiratory monitoring after neuraxial morphine administration for caesarean delivery analgesia, and the SASM/SOAP guidelines for the screening, diagnosis and treatment of obstructive sleep apnea during pregnancy. He is currently the Chair of SOAP research Committee and serves on SOAP’s Board of Directors.
John E Jelovsek
Dr. Jelovsek is the F. Bayard Carter Distinguished Professor of OBGYN at Duke University and serves as Director of Data Science for Women’s Health. He is Board Certified in OBGYN by the American Board of OBGYN and in Female Pelvic Medicine & Reconstructive Surgery by the American Board of OBGYN and American Board of Urology. He has an active surgical practice in urogynecology based out of Duke Raleigh. He has expertise as a clinician-scientist in developing and evaluating clinical prediction models using traditional biostatistics and machine learning approaches. These “individualized” patient-centered prediction tools aim to improve decision-making regarding the prevention of lower urinary tract symptoms (LUTS) and other pelvic floor disorders after childbirth (PMID:29056536), de novo stress urinary incontinence and other patient-perceived outcomes after pelvic organ prolapse surgery, risk of transfusion during gynecologic surgery, and urinary outcomes after mid-urethral sling surgery (PMID: 26942362). He also has significant expertise in leading trans-disciplinary teams through NIH-funded multi-center research networks and international settings. As alternate-PI for the Cleveland Clinic site in the NICHD Pelvic Floor Disorders Network, he was principal investigator on the CAPABLe trial (PMID: 31320277), one of the largest multi-center trials for fecal incontinence studying anal exercises with biofeedback and loperamide for the treatment of fecal incontinence. He was the principal investigator of the E-OPTIMAL study (PMID: 29677302), describing the long-term follow up sacrospinous ligament fixation compared to uterosacral ligament suspension for apical vaginal prolapse. He was also primary author on research establishing the minimum important clinical difference for commonly used measures of fecal incontinence. Currently, he serves as co-PI in the NIDDK Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) (U01DK097780-05) where he has been involved in studies in the development of Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29) and LURN SI-10 questionnaires for men and women with LUTS. He is also the site-PI for the PREMIER trial (1R01HD105892): Patient-Centered Outcomes of Sacrocolpopexy versus Uterosacral Ligament Suspension for the Treatment of Uterovaginal Prolapse.
Brittany A Davidson
My research passion lies at the intersection of gynecologic cancers and palliative care, helping patients with GYN cancers and their families navigate the journey of their cancer diagnoses to maximize their quality of life and mitigate aggressive and futile care near the end of life. I am also passionate about how the healthcare team communicates with patients and their families. Cancer care should be patient-centered based on an individual's own values--this requires comprehensive goals of care conversations early and often throughout the cancer trajectory. This has led me to become involved in VitalTalk Communication Skills training, which I have taught both locally at Duke and across the country to clinicians in various clinical settings.
Clinically, caring for patients with gestational trophoblastic neoplasms and cancers in adolescents and young adults is a rewarding aspect of my job. Helping patients and their families navigate cancer diagnoses and the potential impact this has on growing families is rewarding. I enjoy working in a multi-disciplinary approach with our reproductive endocrinology, psychology, and cancer support teams to maximize longevity, quality of life and family building opportunities.
As the program director for the OB/GYN department, medical education and simulation is also near and dear to my heart. I find great joy in mentoring trainees at all stages and in all venues--clinically, research, and professionally.
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