bluuebunny/crossref_metadata_2025_split huggingface dataset:
Vaginal Hysterectomy for Treatment of Cervical Ectopic Pregnancy
Authors: Alammari Roa , Thibodeau Renee , Harmanli Oz 
Published: December 2016

BACKGROUND:
Cervical ectopic pregnancy can lead to catastrophic hemorrhage, and may be managed conservatively with intra-amniotic methotrexate (MTX), systemic MTX, or both; surgical evacuation with or without balloon tamponade; and uterine artery embolization. However, some patients require hysterectomy, which has traditionally been performed abdominally.

CASE:
A 39-year-old parous woman was diagnosed with cervical ectopic pregnancy at an estimated 7 1/7 weeks of gestation. Her β-hCG level remained at 29,433 milli-international units/mL, and the gestational sac persisted on ultrasonography after first intra-amniotic then multidose systemic MTX treatment. After a review of other fertility-sparing procedures, she chose definitive treatment with hysterectomy because she did not desire future childbearing. She underwent a successful vaginal hysterectomy, a novel approach for this condition.

CONCLUSION:
Vaginal hysterectomy can be performed successfully for treatment of cervical ectopic pregnancy in patients who have completed childbearing and for whom conservative treatment has failed.
Central Fetal Monitoring With and Without Computer Analysis
Authors: Nunes Inês , Ayres-de-Campos Diogo , Ugwumadu Austin , Amin Pina , Banfield Philip , Nicoll Antony , Cunningham Simon , Sousa Paulo , Costa-Santos Cristina , Bernardes João ,   for the Fetal Monitoring and Alert (FM-ALERT) Study Group
Published: December 2016

OBJECTIVE:
To evaluate whether intrapartum fetal monitoring with computer analysis and real-time alerts decreases the rate of newborn metabolic acidosis or obstetric intervention when compared with visual analysis.

METHODS:
A randomized clinical trial carried out in five hospitals in the United Kingdom evaluated women with singleton, vertex fetuses of 36 weeks of gestation or greater during labor. Continuous central fetal monitoring by computer analysis and online alerts (experimental arm) was compared with visual analysis (control arm). Fetal blood sampling and electrocardiographic ST waveform analysis were available in both arms. The primary outcome was incidence of newborn metabolic acidosis (pH less than 7.05 and base deficit greater than 12 mmol/L). Prespecified secondary outcomes included operative delivery, use of fetal blood sampling, low 5-minute Apgar score, neonatal intensive care unit admission, hypoxic–ischemic encephalopathy, and perinatal death. A sample size of 3,660 per group (N=7,320) was planned to be able to detect a reduction in the rate of metabolic acidosis from 2.8% to 1.8% (two-tailed α of 0.05 with 80% power).

RESULTS:
From August 2011 through July 2014, 32,306 women were assessed for eligibility and 7,730 were randomized: 3,961 to computer analysis and online alerts, and 3,769 to visual analysis. Baseline characteristics were similar in both groups. Metabolic acidosis occurred in 16 participants (0.40%) in the experimental arm and 22 participants (0.58%) in the control arm (relative risk 0.69 [0.36–1.31]). No statistically significant differences were found in the incidence of secondary outcomes.

CONCLUSION:
Compared with visual analysis, computer analysis of fetal monitoring signals with real-time alerts did not significantly reduce the rate of metabolic acidosis or obstetric intervention. A lower-than-expected rate of newborn metabolic acidosis was observed in both arms of the trial.

CLINICAL TRIAL REGISTRATION:
ISRCTN Registry, http://www.isrctn.com, ISRCTN42314164.
Factors Underlying the Temporal Increase in Maternal Mortality in the United States
Authors: Joseph K. S. , Lisonkova Sarka , Muraca Giulia M. , Razaz Neda , Sabr Yasser , Mehrabadi Azar , Schisterman Enrique F. 
Published: December 2016

OBJECTIVE:
To identify the factors underlying the recent increase in maternal mortality ratios (maternal deaths per 100,000 live births) in the United States.

METHODS:
We carried out a retrospective study with data on maternal deaths and live births in the United States from 1993 to 2014 obtained from the birth and death files of the Centers for Disease Control and Prevention. Underlying causes of death were examined between 1999 and 2014 using International Classification of Diseases, 10th Revision (ICD-10) codes. Poisson regression was used to estimate maternal mortality rate ratios (RRs) and 95% confidence intervals (CIs) after adjusting for the introduction of a separate pregnancy question and the standard pregnancy checkbox on death certificates and adoption of ICD-10.

RESULTS:
Maternal mortality ratios increased from 7.55 in 1993, to 9.88 in 1999, and to 21.5 per 100,000 live births in 2014 (RR 2014 compared with 1993 2.84, 95% CI 2.49–3.24; RR 2014 compared with 1999 2.17, 95% CI 1.93–2.45). The increase in maternal deaths from 1999 to 2014 was mainly the result of increases in maternal deaths associated with two new ICD-10 codes (O26.8, ie, primarily renal disease; and O99, ie, other maternal diseases classifiable elsewhere); exclusion of such deaths abolished the increase in mortality (RR 1.09, 95% CI 0.94–1.27). Regression adjustment for improvements in surveillance also abolished the temporal increase in maternal mortality ratios (adjusted maternal mortality ratios 7.55 in 1993, 8.00 per 100,000 live births in 2013; adjusted RR 2013 compared with 1993 1.06, 95% CI 0.90–1.25).

CONCLUSION:
Recent increases in maternal mortality ratios in the United States are likely an artifact of improvements in surveillance and highlight past underestimation of maternal death. Complete ascertainment of maternal death in populations remains a challenge even in countries with good systems for civil registration and vital statistics.
Oncologic Outcomes Following Laparoscopic versus Open Resection of pT4 Colon Cancer: A Systematic Review and Meta-analysis
Authors: Feinberg Adina E. , Chesney Tyler R. , Acuna Sergio A. , Sammour Tarik , Quereshy Fayez A. 
Published: December 2016

BACKGROUND:
Locally advanced colon cancer is considered a relative contraindication for laparoscopic resection, and clinical trials addressing the oncologic safety are lacking.

OBJECTIVE:
The aim of this study was to synthesize the oncologic outcomes associated with laparoscopic versus conventional open surgery for locally advanced colon cancers.

DATA SOURCES:
We systematically searched Medline, Embase, Central, and ClinicalTrials.gov.

STUDY SELECTION:
Two reviewers independently screened the literature for controlled trials or observational studies comparing curative-intent laparoscopic and open surgery for colon cancer. Studies were included if it was possible to determine outcomes for the T4 colon cancers separately, either reported in the article or calculated with individual patient data.

INTERVENTIONS:
Included studies were systematically reviewed and assessed for risk of bias. Meta-analyses were done by using random-effects models.

MAIN OUTCOME MEASURES:
Outcomes of interest were disease-free survival, overall survival, resection margins, and lymph node harvest.

RESULTS:
Of 2878 identified studies, 5 observational studies met eligibility criteria with a total of 1268 patients (675 laparoscopic, 593 open). There was no significant difference in overall survival (HR, 1.28; 95% CI, 0.94–1.72), disease-free survival (HR, 1.20; 95% CI, 0.90–1.61), or positive surgical margins (OR, 1.16; 95% CI, 0.58–2.32) between the groups. The open group had a larger lymph node retrieval (pooled mean difference, 2.26 nodes; 95% CI, 0.58–3.93). The pooled rate of conversion from laparoscopy to an open procedure was 18.6% (95% CI, 9.3%–27.9%).

LIMITATIONS:
These results are limited by the inherent selection bias in the included nonrandomized studies.

CONCLUSIONS:
Based on the available literature, minimally invasive resection of selected locally advanced colon cancer is oncologically safe. There is a small increase in lymph node harvest with open resections, but it is unclear whether this is clinically significant. Surgeons should be prepared for a significant rate of conversion to laparotomy as required to perform en bloc resection.
Long-term Experience of Magnetic Anal Sphincter Augmentation in Patients With Fecal Incontinence
Authors: Sugrue Jeremy , Lehur Paul-Antoine , Madoff Robert D. , McNevin Shane , Buntzen Steen , Laurberg Søren , Mellgren Anders 
Published: December 2016

BACKGROUND:
Magnetic anal sphincter augmentation is a novel technique for the treatment of patients with fecal incontinence.

OBJECTIVE:
The current study reports the long-term effectiveness and safety of this new treatment modality.

DESIGN:
This was a prospective multicenter pilot study.

SETTINGS:
The study was performed at 4 clinical sites in Europe and the United States.

PATIENTS:
The cohort included patients with severe fecal incontinence for ≥6 months who had previously failed conservative therapy and were implanted with a magnetic anal sphincter device between 2008 and 2011.

MAIN OUTCOME MEASURES:
Adverse events, symptom severity, quality of life, and bowel diary data were collected.

RESULTS:
A total of 35 patients (34 women) underwent magnetic anal sphincter augmentation. The median length of follow-up was 5.0 years (range, 0–5.6 years), with 23 patients completing assessment at 5 years. Eight patients underwent a subsequent operation (7 device explantations) because of device failure or complications, 7 of which occurred in the first year. Therapeutic success rates, with patients who underwent device explantation or stoma creation counted as treatment failures, were 63% at year 1, 66% at year 3 and 53% at year 5. In patients who retained their device, the number of incontinent episodes per week and Cleveland Clinic incontinence scores significantly decreased from baseline, and there were significant improvements in all 4 scales of the Fecal Incontinence Quality of Life instrument. There were 30 adverse events reported in 20 patients, most commonly defecatory dysfunction (20%), pain (14%), erosion (11%), and infection (11%).

LIMITATIONS:
This study does not allow for comparison between surgical treatments and involves a limited number of patients.

CONCLUSIONS:
Magnetic anal sphincter augmentation provided excellent outcomes in patients who retained a functioning device at long-term follow-up. Protocols to reduce early complications will be important to improve overall results.
Truth in Reporting: How Data Capture Methods Obfuscate Actual Surgical Site Infection Rates within a Health Care Network System
Authors: Bordeianou Liliana , Cauley Christy E. , Antonelli Donna , Bird Sarah , Rattner David , Hutter Matthew , Mahmood Sadiqa , Schnipper Deborah , Rubin Marc , Bleday Ronald , Kenney Pardon , Berger David 
Published: December 2016

BACKGROUND:
Two systems measure surgical site infection rates following colorectal surgeries: the American College of Surgeons National Surgical Quality Improvement Program and the Centers for Disease Control and Prevention National Healthcare Safety Network. The Centers for Medicare & Medicaid Services pay-for-performance initiatives use National Healthcare Safety Network data for hospital comparisons.

OBJECTIVE:
This study aimed to compare database concordance.

DESIGN:
This is a multi-institution cohort study of systemwide Colorectal Surgery Collaborative. The National Surgical Quality Improvement Program requires rigorous, standardized data capture techniques; National Healthcare Safety Network allows 5 data capture techniques. Standardized surgical site infection rates were compared between databases. The Cohen κ-coefficient was calculated.

SETTING:
This study was conducted at Boston-area hospitals.

PATIENTS:
National Healthcare Safety Network or National Surgical Quality Improvement Program patients undergoing colorectal surgery were included.

MAIN OUTCOME MEASURES:
Standardized surgical site infection rates were the primary outcomes of interest.

RESULTS:
Thirty-day surgical site infection rates of 3547 (National Surgical Quality Improvement Program) vs 5179 (National Healthcare Safety Network) colorectal procedures (2012–2014). Discrepancies appeared: National Surgical Quality Improvement Program database of hospital 1 (N = 1480 patients) routinely found surgical site infection rates of approximately 10%, routinely deemed rate “exemplary” or “as expected” (100%). National Healthcare Safety Network data from the same hospital and time period (N = 1881) revealed a similar overall surgical site infection rate (10%), but standardized rates were deemed “worse than national average” 80% of the time. Overall, hospitals using less rigorous capture methods had improved surgical site infection rates for National Healthcare Safety Network compared with standardized National Surgical Quality Improvement Program reports. The correlation coefficient between standardized infection rates was 0.03 (p = 0.88). During 25 site–time period observations, National Surgical Quality Improvement Program and National Healthcare Safety Network data matched for 52% of observations (13/25). κ = 0.10 (95% CI, –0.1366 to 0.3402; p = 0.403), indicating poor agreement.

LIMITATIONS:
This study investigated hospitals located in the Northeastern United States only.

CONCLUSIONS:
Variation in Centers for Medicare & Medicaid Services-mandated National Healthcare Safety Network infection surveillance methodology leads to unreliable results, which is apparent when these results are compared with standardized data. High-quality data would improve care quality and compare outcomes among institutions.
Long-term Quality of Life of Patients With Permanent End Ileostomy: Results of a Nationwide Cross-Sectional Survey
Authors: Schiergens Tobias S. , Hoffmann Verena , Schobel Tamara N. , Englert Gerhard H. , Kreis Martin E. , Thasler Wolfgang E. , Werner Jens , Kasparek Michael S. 
Published: December 2016

Background:
Patients with permanent end ileostomy are at high risk for detrimental stomal effects on their quality of life. However, little is known about the long-term quality of life of these patients.

OBJECTIVE:
The purpose of this study was to assess long-term quality of life in patients with permanent end ileostomy.

DATA SOURCES:
Registration at the German self-help organization ILCO was used for this study.

STUDY SELECTION:
Selection included a cross-sectional survey of 1434 patients with permanent end ileostomy.

MAIN OUTCOME MEASURES:
Quality of life was assessed using the Medical Outcomes Study Short Form 36, including physical and mental component summary scores, the Gastrointestinal Quality of Life Index, and the Cleveland Global Quality of Life Index. Multivariate risk factor analysis was performed.

RESULTS:
A total of 783 responders were included. Indications for ileostomy included ulcerative colitis (44%), Crohn’s disease (38%), and colorectal cancer (7%). Adverse effects on daily life because of stoma were reported by 72% of participants. Quality of life was significantly impaired compared with the general population on all of the summary scores and several subscales (physical component summary: 44.6 ± 10.4 (mean ± SD) vs 50.2 ± 10.2, p < 0.001; mental component summary: 47.5 ± 10.7 vs 51.5 ± 10.2, p < 0.001; Gastrointestinal Quality of Life Index: 94.4 ± 16.4 vs 126.0, p < 0.001). Stoma care problems affecting quality of life were reported by 63% of respondents. These included parastomal hernia (p < 0.001), stenosis (p = 0.003), and prolapse (p = 0.008). Vitamin B12, iron, and zinc deficiencies were also associated with diminished quality of life; in particular, vitamin B12 deficiency was associated with reduced mental and emotional quality of life.

LIMITATIONS:
Not all patients undergoing ileostomy in Germany are registered at ILCO, and there were many nonresponders. In addition, the inherent limitations of cross-sectional studies should be considered, including the response–shift phenomenon.

CONCLUSIONS:
Quality of life was markedly impaired in patients with permanent end ileostomy as compared with the general population. The main reasons were stoma-associated morbidity and nutritional deficiency syndromes. These findings highlight the importance of prevention, screening, and adequate treatment.
Percutaneous Posterior Tibial Nerve Stimulation vs Perianal Application of Glyceryl Trinitrate Ointment in the Treatment of Chronic Anal Fissure: A Randomized Clinical Trial
Authors: Ruiz-Tovar Jaime , Llavero Carolina 
Published: December 2016

BACKGROUND:
Current therapeutic guidelines for the treatment of chronic anal fissure establish a medical approach as the first step. Glyceryl trinitrate ointment is the most popular of the available topical treatments in Spain but it is associated with the appearance of headache.

OBJECTIVE:
The purpose of this study was to compare the compliance rate among patients receiving glyceryl trinitrate treatment for chronic anal fissure with that among patients receiving percutaneous posterior tibial nerve stimulation.

DESIGN:
This was a prospective randomized study.

SETTINGS:
The study was conducted at Garcilaso Clinic (Madrid, Spain).

PATIENTS:
Subjects with persistent anal fissure despite hygiene and dietary measures applied over at least a 6-week period were included.

INTERVENTIONS:
Study interventions were perianal application of glyceryl trinitrate ointment (twice daily for 8 weeks) and percutaneous posterior tibial nerve stimulation (30-minute session 2 days per week for 8 weeks).

MAIN OUTCOME MEASURES:
Compliance with the treatment and healing rate of chronic anal fissure in patients receiving glyceryl trinitrate ointment or undergoing percutaneous posterior tibial nerve stimulation were evaluated.

RESULTS:
Forty patients were included in each group. In the glyceryl trinitrate ointment group, 15% of the patients discontinued treatment because of disabling headaches. There were no adverse effects or treatment withdrawals in the percutaneous posterior tibial nerve stimulation group (p = 0.033). After 8 weeks of treatment, the healing rate in the percutaneous posterior tibial nerve stimulation group was 87.5% vs 65.0% in the glyceryl trinitrate ointment group (p = 0.018).

LIMITATIONS:
Because the patients were not blinded to the treatment, we cannot rule out a placebo effect derived from the needle insertion in the percutaneous posterior tibial nerve stimulation group.

CONCLUSIONS:
Percutaneous posterior tibial nerve stimulation is a safe and effective alternative that is in some ways superior to glyceryl trinitrate ointment for the treatment of chronic anal fissure.
Effect of Low-Concentration, Nonmydriatic Selective Alpha-Adrenergic Agonist Eyedrops on Upper Eyelid Position
Authors: Mendonça Taís B. , Lummertz Atauíne P. , Bocaccio Francisco J.L. , Procianoy Fernando 
Published: December 2016

BACKGROUND
Ptosis after botulinum toxin injection is a disturbing complication. Decongestant and antiglaucoma eyedrops are frequently prescribed for temporary improvement of eyelid ptosis. Although frequently cited on informal communications, the effect of these drugs on eyelid position has never been compared in a formal study.

OBJECTIVE
To measure the effect of low-concentration, nonmydriatic selective alpha agonist eyedrops on upper eyelid position.

METHODS AND MATERIALS
This nonrandomized clinical trial enrolled 20 healthy subjects aged 18 to 50 years. The upper margin–reflex distance (MRD1) was measured before, 30, 60, and 120 minutes after administration of 1 drop of brimonidine 0.2%, phenylephrine 0.12%, or naphazoline 0.05% to the left eye.

RESULTS
There was no statistically significant difference in mean MRD1 between the brimonidine and phenylephrine groups when comparing baseline to all other study time points. After administration of naphazoline 0.05%, MRD1 had a mean increase of 0.56 ± 0.11 mm (p < 0.001) after 30 minutes, 0.47 ± 0.12 mm (p = 0.001) after 60 minutes, and 0.26 ± 0.09 mm (p = 0.028) after 120 minutes when compared with baseline.

CONCLUSION
Brimonidine 0.2% and phenylephrine 0.12% have no effect on eyelid aperture, but naphazoline 0.05% eyedrops could be useful for temporary relief of upper eyelid ptosis in selected patients.
Reliability, Validity, and Sensitivity to Change Overtime of the Modified Melasma Area and Severity Index Score
Authors: Abou-Taleb Doaa A.E. , Ibrahim Ahmed K. , Youssef Eman M.K. , Moubasher Alaa E.A. 
Published: December 2016

BACKGROUND
The new modified Melasma Area and Severity Index (mMASI) score, the recently used outcome measure for melasma, has not been tested to determine its sensitivity to change in melasma.

OBJECTIVE
To determine the reliability, validity, and sensitivity to change overtime of the mMASI score in assessment of the severity of melasma.

METHODS
Pearson correlation, Cronbach alpha, and intraclass correlation coefficient were calculated to assess the reliability of the mMASI score. Validity of the mMASI scale was carried out using Spearman correlation between mMASI total score (before and after treatment), clinical data, and patient's responses.

RESULTS
The mMASI score showed excellent reliability and good validity for assessment of the severity of melasma. The authors also determined that the mMASI score demonstrated sensitivity to change over time.

CONCLUSION
An excellent degree of agreement between the mMSAI and MASI scores was revealed. The mMASI score is reliable, valid, and responsive to change in the assessment of severity of melasma. Moreover, the mMASI score was found to be easier to learn and perform and simpler in calculation compared with the MASI score. Overall, the mMASI score can effectively replace the MASI score.
Frailty Assessed by the Forecast is a Valid Tool to Predict Short-Term Outcome after Transcatheter Aortic Valve Replacement
Authors: Kobe Adrian R. , Meyer Alexander , Elmubarak Hassan , Kempfert Jörg , Pavicevic Jovana , Maisano Francesco , Walther Thomas , Falk Volkmar , Sündermann Simon H. 
Published: December 2016

Objective The term frailty is frequently used during decision-making in transcatheter heart valve procedures. Nevertheless, frailty is still measured by eyeballing rather than by using standardized frailty assessments. In a previous study, we developed a frailty score in a cardiac surgical patient population including patients, who underwent transcatheter aortic valve replacement (TAVR). Here, we present the results from the subsequent validation study focusing on the TAVR cohort. Methods One hundred thirty patients underwent TAVR. Frailty assessment using the FORECAST (Frailty predicts death One yeaR after Elective CArdiac Surgery Test) was performed. The European System for Cardiac Operative Risk Evaluation and The Society of Thoracic Surgeons (STS) score were assessed as well. Follow-up included assessment of in-hospital and 30-day mortality and morbidity and quality of life using the Short Form-36 questionnaire. Results Mean age was 83.3 years, and 50% were female. Logistic European System for Cardiac Operative Risk Evaluation was 14.9 ± 8.7%, and STS score was 5.1 ± 3.4%. Mean ± standard deviation FORECAST score was 4.8 ± 3.3 points of 15. In-hospital and 30-day mortality were 6.9% and 7.7%, respectively. Thirty-day Short Form-36 assessment showed a decrease in quality of life in five of ten items after the intervention. Receiver operating characteristic curves showed that the FORECAST is a valid tool to predict in-hospital mortality (area under the receiver operating characteristic curve, 0.73). By combining the FORECAST and the STS score, this effect was even higher (area under the receiver operating characteristic curve, 0.77; P = 0.021). Stratifying the patients according to the FORECAST score showed best survival in the lowest frailty group. Conclusions The FORECAST is a valid tool to assess frailty in TAVR patients. The FORECAST is easily assessable and can be included in daily clinical routine.