Management of medial humeral epicondyle fractures in children: a structured review protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

BACKGROUND: Medial humeral epicondyle fractures of the elbow are one of the most common injuries in childhood and often require surgery. There are currently no standardised outcome measures to assess progress after an elbow injury in a child. Wide variation in currently reported outcomes makes comparison of treatment difficult. This study aims to identify outcome measures that have previously been reported in studies evaluating the management of medial epicondyle fractures in children and to facilitate the development of a consensus core outcome set (COS) suitable for use in all future studies of medial humeral epicondyle fractures in children. METHODS/DESIGN: This study will include a systematic review of the academic literature to identify a list of outcome measures that have previously been reported. The list of outcome measures will be used in a consensus setting exercise with focus groups of key stakeholders to identify key outcomes. A Delphi process to include two rounds will then be used to define the most important outcomes to all stakeholders forming the COS. DISCUSSION: Core outcomes represent the minimum expected data reported for a specific condition and will improve the quality of future studies reducing bias, allowing easier comparison and enhancing opportunities for larger meta-analysis. It is anticipated that this COS will form part of the feasibility to a National Institute for Health Research (NIHR) Health Technology Assessment (HTA)-funded trial concerning the management of elbow fractures in children. TRIAL REGISTRATION: Core Outcome Measures in Effectiveness Trials Initiative (COMET), registration number: 949 . Registered on 17 January 2017. Prospero International prospective register of systematic reviews, registration number: CRD 42017057912 . Registered on 16 April 2017.

Surgical Competency for Robot-Assisted Hysterectomy: Development and Validation of a Robotic Hysterectomy Assessment Score (RHAS).

STUDY OBJECTIVE: To develop and validate a procedure-specific scoring algorithm to objectively measure robotic surgical skills during robot-assisted hysterectomy and to facilitate robotic surgery training and education. DESIGN: (Canadian Task Force classification III). SETTING: A National Comprehensive Cancer Network-designated comprehensive cancer center. PATIENTS: Deidentified videos for robot-assisted hysterectomies were evaluated. INTERVENTIONS: Videos from 26 robotic hysterectomies performed by surgeons with varying degrees of experience using the scoring system were evaluated. In phase I, critical elements of a robotic hysterectomy were deconstructed into 6 key domains to assess technical skills for procedure completion. Anchor descriptions were developed for each domain to match a 5-point Likert scale. Delphi methodology was used for content validation. A panel of 5 expert robotic surgeons refined this scoring system. In phase II, video recordings of procedures performed by surgeons with varying degrees of experience (expert, advanced beginner, and novice) were evaluated by blinded expert reviewers using the scoring system. Descriptive statistics were used to summarize the scores for each domain. Intraclass correlation was used to determine the interrater reliability. A p value <.05 was considered significant. MEASUREMENTS AND MAIN RESULTS: The average score for the 3 classes of surgeon was 75.6 for expert, 71.3 for advanced beginner, and 69.0 for novice (p = .006). There were significant differences in scores of most individual domains among the various classes of surgeons. Novice surgeons took significantly longer than expert surgeons to complete their half of a hysterectomy (22.2 vs 12.0 minutes; p = .001). CONCLUSION: This pilot study demonstrates the feasibility of using a standardized rubric for clinical skills assessment in robotic hysterectomy. Blinded expert reviewers were able to differentiate between varying levels of surgical experience using this assessment tool.

Placental Alpha-Microglobulin-1 Test in Resource-Limited Settings: A Cost-Effectiveness Analysis.

OBJECTIVE: To evaluate whether the use of placental alpha-microglobulin-1 (PAMG-1) for the diagnosis of preterm premature rupture of membranes is cost-effective in resource-limited settings. METHODS: We designed a decision-analytic model from a third-party payer's perspective to determine the cost-effectiveness of the PAMG-1 test compared with the traditional diagnostic test of pooling, Nitrazine, and ferning in diagnosing preterm premature rupture of membranes in a resource-limited setting. The primary health outcome of interest is the number of hospital transfers averted by each strategy per 1,000 patients screened. Baseline probabilities and cost assumptions were derived from published literature. We conducted sensitivity analyses using both deterministic and probabilistic models. Cost estimates reflect 2015 U.S. dollars. RESULTS: Under our baseline parameters, the use of a PAMG-1 test was the preferred cost-effective strategy. The PAMG-1 test averted hospital transfers of 447 true-negative patients per 1,000 tested at a cost of $143,407 ($320.82 per hospital transfer averted). The traditional test averted hospital transfers of 395 true-negative patients per 1,000 tested at a cost of $172,652 ($437.40 per hospital transfer averted). In a Monte Carlo simulation of 10 million trials, the PAMG-1 test was selected as the most cost-effective strategy with a frequency of 74%. The traditional test was only selected with a frequency of 26%. The "do-nothing" strategy was not selected throughout the trial. CONCLUSION: Among women presenting at resource-limited settings with a history suspicious of preterm premature rupture of membranes between 24 and 36 weeks of gestation, our analysis provides evidence suggesting that PAMG-1 is the most cost-effective testing strategy.

Preferences for labor and delivery practices between pregnant immigrants and U.S.-born patients: a comparative prospective antenatal survey study.

OBJECTIVE: To compare preferences in pregnant Somali and Sudanese immigrants with US-born women for different labor and delivery procedures and practices. STUDY DESIGN: Pregnant women who received prenatal care services at the Jericho Road Family Practice were surveyed. Ninety-three consecutive patients agreed to participate. A translator-facilitated questionnaire was administered to Somali-, Sudanese-, and U.S.-born women during antenatal visits. RESULTS: For pain relief in labor, 66.7% of U.S.-born, 64.0% of Somali, and 12.5% of Sudanese women preferred epidural analgesia (p = .002). More U.S.-born women preferred for the umbilical cord to be cut by their partners (76.2%) vs. Somali (6.7%) and Sudanese (0%) (p < .001). For infant feeding, more U.S.-born women (47%) preferred only formula feeding (Somali, 3.4%; Sudanese, 0%; p < .001). Responses were not statistically different for other preference questions, such as mobility/position in labor, attendants in labor, and duration of hospital stay. CONCLUSIONS: This prospective survey quantifies the differences in preferences for labor and delivery practices from two foreign populations and from U.S.-born women. This information is useful for all physicians who wish to better meet the needs of individual patients, especially those who are from different cultures and backgrounds.

Community/campus partnership: tailoring geographic information systems for perinatal health planning.

BACKGROUND: Geographic information systems (GIS) are seen as potentially important additions to traditional methods of studying risk factors in maternal and child health, but little is written on actual GIS use by communities. This article describes how one community-university collaboration used GIS for perinatal planning. OBJECTIVE: The objective was to determine whether utilizing GIS could help a community to identify risk and develop potential interventions to address perinatal health problems. METHODS: We tested the use of GIS over a 9-month period, using community-based participatory research (CBPR) methods. Diffusion of innovations (DOI) theory guided this work. RESULTS: This collaboration resulted in the development of a perinatal GIS model that helped community members to decide where to focus interventions and in continued use of GIS for planning. CONCLUSION: Close collaboration early in the planning process, coupled with the incorporation of DOI theory, is necessary for communities to use GIS to plan perinatal interventions.

Association of pre-pregnancy maternal body mass and maternal weight gain to newborn outcomes in twin pregnancies.

BACKGROUND: The rate of twin gestations is now about 3% of all pregnancies. The study objective was to investigate the association between twin pregnancy newborn outcomes and maternal weight. METHODS: Birth certificate information of 1,342 sets of live-born twin deliveries collected in a regional perinatal data system from a contiguous eight-county area in upstate New York was studied. RESULTS: The obese maternal pre-pregnancy BMI category was correlated with an increased odds ratio of a "Type I" (both a > or =36-week gestation and a > or =2,500-g average twin weight) newborn outcome (adjusted OR 1.92; 95% CI: 1.43, 2.56). For total maternal weight gain, there was an increased odds ratio of having a Type I newborn outcome with >25 kg weight gain (adjusted OR 2.24; 95% CI: 1.51, 3.33). CONCLUSIONS: Based on this population-based study, we conclude that both maternal pre-pregnancy BMI and total maternal weight gain are associated with twin newborn outcomes.

Triplet gestation outcomes in relation to maternal prepregnancy body mass index and weight gain.

OBJECTIVE: To study prepregnancy maternal body mass index (BMI) and overall maternal weight gain in triplet gestations in relation to maternal and newborn outcomes. STUDY DESIGN: This was a retrospective study of birth certificate data of all live-born triplet gestations occurring between 1999 and 2003 in an eight-county region in New York. An analysis of computerized birth certificate data for variables related to pregnancy and newborn outcomes was conducted, looking at neonatal birth weight, neonatal gestational age, and the occurrence of the maternal pregnancy complications of gestational diabetes, gestational hypertension, and preeclampsia. RESULTS: In 56 triplet gestations studied, the prepregnancy BMI was not associated with mean newborn birth weights and gestational age at delivery. The total maternal weight gain was associated with increasing mean birth weight and higher gestational age at delivery. Pregnancy complications in triplet pregnancies of gestational diabetes and gestational hypertension were associated with prepregnancy BMI, but not maternal weight gain. CONCLUSION: For triplet gestations, a normal prepregnancy BMI and a total gestational weight gain of at least 15.9 - 20.5 kg (35 - 45 lb) are associated with fewer pregnancy complications.

Population-based analysis of hypertensive disorders in pregnancy.

OBJECTIVE: To determine the population-based incidence of hypertensive diseases in pregnancy in Western New York. METHODS: A database of 77,358 women with singleton pregnancies was analyzed using birth certificate data. The incidence of pregnancies complicated by gestational hypertension, preeclampsia, and eclampsia was determined. RESULTS: The overall incidence of pregnancy-associated hypertensive disease varied slightly from 1999 to 2003. The incidence of preeclampsia decreased from 1.8% to 1.1% (p < 0.01). This decrease persisted over time, despite controlling for known risk factors, such as body mass index, age, ethnicity, parity, smoking, diabetes, and chronic hypertension. CONCLUSION: The incidence of pregnancy-related hypertensive disorders slightly decreased in our population in the last 5 years, with a decline in the rate of preeclampsia accounting for this change. Further analysis may provide additional insights into the population-based incidence of preeclampsia.

Is there gender bias toward male residents in an obstetrics and gynecology training program?

OBJECTIVE: To assess whether male obstetric and gynecologic residents experience gender bias in training for vaginal deliveries. STUDY DESIGN: We compared male and female resident training experiences in vaginal deliveries in a community hospital. Three analyses were performed: (1) total number of deliveries performed by male and female residents, (2) percentage of deliveries that male and female residents performed with female attendings, and (3) percentage of attending deliveries performed by male residents. The main outcome measure was whether male residents had limited training opportunities with female attendings as compared to female residents. RESULTS: There was no difference between male and female residents with regard to total deliveries performed per rotation. Male residents were as likely as female residents to participate in vaginal deliveries by a female attending. Conversely, female attendings were as likely as male attendings to have a male resident attend their patients' deliveries. CONCLUSION: There was no evidence of gender bias regarding male resident training opportunities in vaginal deliveries in an obstetric and gynecologic training program.

Temporal trends in the rates of trial of labor in low-risk pregnancies and their impact on the rates and success of vaginal birth after cesarean delivery.

OBJECTIVE: The national rate of vaginal birth after cesarean delivery decreased by 55% between 1996 and 2002. The objective of this investigation was to determine, in our population in upstate New York, whether this decline in the vaginal birth after cesarean delivery rate was due to temporal changes in the trial of labor rates or in the vaginal birth after cesarean delivery success rates. STUDY DESIGN: Regional perinatal databases were used to obtain birth certificate data from a total of 135,833 live births in upstate New York from 1998 to 2002. Trial of labor, vaginal birth after cesarean delivery, and vaginal birth after cesarean delivery success rates were calculated for the 11,446 women who had had a previous cesarean delivery and a singleton, low-risk pregnancy at > or = 37 weeks of gestation. Additional factors that were analyzed included age, race, education, insurance, body mass index, parity, gestation, area of residence, prenatal care provider, size of hospital, and level of newborn nursery specialization. Tests for trends were conducted by year for each of the variables. RESULTS: The trial of labor rate declined 39% from 58.7 in 1998 to 35.7 per 100 eligible women in 2002 (P < .01). The decline in trial of labor rates persisted after stratification within almost all groups (P < .01). The overall vaginal birth after cesarean delivery rate decreased 44%, from 42.7 in 1998 to 24.1 per 100 eligible women in 2002 (P < .01). The decline in vaginal birth after cesarean delivery rates persisted after stratification within almost all groups (P < .01). The rate of vaginal birth after cesarean delivery success was unchanged from 1998 to 2002 (P = not significant). CONCLUSION: We found a major decline in trial of labor and vaginal birth after cesarean delivery rates in low-risk women from 1998 to 2002. There was no change in vaginal birth after cesarean delivery success in those patients who attempted trial of labor. This suggests that the decline in the vaginal birth after cesarean delivery rates that have been observed nationally may be due to a decline in trial of labor attempts and not to a change in vaginal birth after cesarean delivery success rates. The steep declines in trial of labor attempts and vaginal birth after cesarean deliveries suggest that there was a rapid change in the perception of optimal treatment practices for these patients by obstetricians.

Increasing prepregnancy body mass index: analysis of trends and contributing variables.

OBJECTIVE: In the United States, obesity has increased steadily. As obesity in pregnancy is a high-risk obstetric situation, important questions are whether there has been a trend toward higher prepregnancy body mass indexes (BMIs) in women who have become pregnant and if there are subgroups at risk. The objective of this study was to analyze the shifts, if any, in the prepregnancy BMIs in women who delivered. STUDY DESIGN: Analysis of the birth certificate data collected in a regional perinatal data system of all live born deliveries (79,022 cases) occurring in a contiguous 8-county area in upstate New York from 1999 to 2003. RESULTS: From 1999 to 2003, there was an overall increase in the mean prepregnancy BMI of the total delivery population (P < .01). There was a relative 11% increase in the Institute of Medicine (IOM) overweight (P < .01) and a relative 8% increase in the obese (P < .01) categories. There was an increase in the numbers of women in the IOM overweight or obese categories in these subgroups (P < .05): age (all subgroups), ethnicity (white and black), education (all subgroups), insurance type (all subgroups), previous live births (all subgroups), urbanization status (all subgroups), median family income of ZIP code area (all subgroups), and smoking (both smokers and nonsmokers). CONCLUSION: There was a significant increase toward higher prepregnancy BMIs across multiple subgroups. Our study demonstrates that increased prepregnancy BMI is an issue that spans almost the entire spectrum of subgroups of patients who delivered.