bluuebunny/crossref_metadata_2025 huggingface dataset:
Angiotensin-Converting Enzyme Inhibitors and the Risk of Congenital Malformations
Authors: Bateman Brian T. , Patorno Elisabetta , Desai Rishi J. , Seely Ellen W. , Mogun Helen , Dejene Sara Z. , Fischer Michael A. , Friedman Alexander M. , Hernandez-Diaz Sonia , Huybrechts Krista F.
Published: December 2016

OBJECTIVE:

To examine the association between first-trimester angiotensin-converting enzyme (ACE) inhibitor exposure and the risk of overall major congenital, cardiac, and central nervous system malformations.

METHODS:

We used a cohort of completed pregnancies linked to liveborn neonates derived from Medicaid claims from 2000 to 2010. We examined the risk of malformations associated with first-trimester exposure to an ACE inhibitor. Propensity score–based methods were used to control for potential confounders including maternal demographics, medical conditions, exposure to other medications, and measures of health care utilization.

RESULTS:

The cohort included 1,333,624 pregnancies, of which 4,107 (0.31%) were exposed to ACE inhibitors during the first trimester. The prevalence of overall malformations in the ACE inhibitor–exposed pregnancies was 5.9% compared with 3.3% in the unexposed (unadjusted relative risk, 1.82; 95% confidence interval [CI] 1.61–2.06), of cardiac malformations was 3.4% compared with 1.2% (relative risk 2.95, 95% CI 2.50–3.47), and of central nervous system malformations was 0.27% compared with 0.18% (relative risk 1.46, 95% CI 0.81–2.64). After restricting the cohort to pregnancies complicated by chronic hypertension (both exposed and unexposed) and accounting for other confounding factors, there was no significant increase in the risk of any of the outcomes assessed. Relative risks associated with first-trimester ACE inhibitor exposure were 0.89 (95% CI 0.75–1.06) for overall malformations, 0.95 (95% CI 0.75–1.21) for cardiac malformations, and 0.54 (95% CI 0.26–1.11) for CNS malformations.

CONCLUSIONS:

After accounting for confounders, among women with hypertension, exposure to ACE inhibitors during the first trimester was not associated with an increased risk of major congenital malformations.
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.
Hysteroscopic Sterilization With Essure
Authors: Walter Jessica R. , Ghobadi Comeron W. , Hayman Emily , Xu Shuai
Published: December 2016

In September 2015, the U.S. Food and Drug Administration (FDA) convened a meeting of the Obstetrics and Gynecology Advisory Board Committee to address the sudden increase of patient-reported adverse events surrounding Essure, a Class III device offering a less invasive method for permanent female sterilization. After a review of the premarketing and postmarketing data and existing scientific literature, the FDA concluded there was insufficient evidence to remove the device from the market. However, the FDA did release a new guidance document requiring a black box warning for the device and ordered a new postmarketing study comparing Essure’s safety and efficacy with laparoscopic tubal sterilization. The device was first approved in 2002 based on nonrandomized, single-arm prospective clinical studies. Since its approval, the device has grown in popularity, particularly in the United States. The driving forces for the sudden increase in adverse event reporting starting in 2013 related to the device remain unclear. Until completion of the new postmarketing study, there will continue to be significant uncertainty of the technology's risk–benefit profile. The controversy with Essure underscores the need for obstetricians and gynecologists to be actively involved in the lifecycle of medical devices. This includes actively reporting adverse events associated with devices to the FDA, supporting the implementation of unique device identifiers enriched with clinical records and paired with insurance claims, and stewarding robust device-specific registries.
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.
Pigmentation and Pregnancy
Authors: Bieber Amy Kalowitz , Martires Kathryn J. , Stein Jennifer A. , Grant-Kels Jane M. , Driscoll Marcia S. , Pomeranz Miriam Keltz
Published: December 2016

Changes in melanocytic nevi during pregnancy are frequently attributed to the new hormonal milieu and are dismissed without concern for malignancy. Recent studies suggest that pregnancy itself does not induce significant change in nevi, and delays in the assessment of changing moles may contribute to the often more advanced nature of melanomas diagnosed during or soon after pregnancy. Nevi on the breasts and abdomen can grow as a result of skin expansion, but studies have found no significant changes in nevi located in more stable areas such as the back or lower extremities. There is also insufficient evidence to support the notion that nevi darken during pregnancy. As such, any changing nevus that would raise concern for malignancy in a nonpregnant patient should do so in a pregnant patient as well. Pregnancy can, however, induce physiologic pigmentary changes that are often worrisome to both patients and physicians. These benign changes include melasma, pigmentary demarcation lines, secondary areola, and linea nigra as well as other less common findings. It is important for physicians to recognize these changes as physiologic to provide adequate reassurance to their patients and avoid unnecessary stress.
The Obstetrician–Gynecologist's Role in Detecting, Preventing, and Treating Depression
Authors: Bhat Amritha , Reed Susan D. , Unützer Jürgen
Published: December 2016

Women are at a higher risk for depression than are men, and this risk is especially pronounced at specific reproductive periods of vulnerability: adolescence, pregnancy, postpartum, and the menopausal transition. Obstetrician–gynecologists are often the health care providers who women consult during these vulnerable periods, usually presenting with conditions or complaints other than depression or anxiety. Presenting symptoms are frequently known comorbidities with depression or are risk factors for depression. Thus, by screening for depression and other mood disorders in these critical periods, in addition to screening at routine intervals such as annual examinations, obstetricians and gynecologists can play an important role in early detection, prevention, and treatment of mood disorders and their comorbid conditions. We provide a framework for depression management within busy obstetric gynecology settings using new integrated care models for mental health.
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.
What Is New in Global Women's Health? (Part 1)
Authors: Autry Amy M. , Petersen Scott M.
Published: December 2016

This month we focus on current research in global women's health in obstetrics and gynecology. Drs. Autry and Petersen discuss six recent publications, which are concluded with a “bottom line” that is the take-home message. The complete reference for each can be found in Box 1 on this page, along with direct links to the abstracts.
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.
Extrapleural Pneumonectomy for Malignant Pleural Mesothelioma: A Novel Mini-Invasive Technique
Authors: Caronia Francesco Paolo , Fioretti Alfonso , Santini Mario , Arrigo Ettore
Published: December 2016

We report a novel less-invasive extrapleural pneumonectomy for early-stage malignant pleural mesothelioma without rib spreading. Our approach is unique and differed from the previously reported cases, because we used one skin incision and two small intercostal incisions with videothoracoscopic viewing without rib spreading. The pleural dissection and approach to the hilum for pneumonectomy were performed through a 4- to 5-cm port incision in the sixth intercostal space. Another 4- to 5-cm port was made in the eight intercostal space through the same skin incision and was used for diaphragm resection and reconstruction. At the end of the surgery, the skin incision was enlarged to 8 cm; through which and the first port in the sixth intercostal space, the resected specimen was retrieved. Three cycles of adjuvant chemotherapy followed by radiation therapy were administered. Eleven-month follow-up showed no recurrence.
Fluctuating Vestibulo-Ocular Reflex in Ménière's Disease
Authors: Yacovino Dario A. , Hain Timothy C. , Musazzi Maria
Published: December 2016

Objectives:

To describe the fluctuating high velocity vestibular ocular-reflex (VOR) during the Ménière's attacks and correlate those features with pathophysiology.

Patients:

A patient with unilateral Ménière's disease (MD) was evaluated closely during and after acute vertigo episodes.

Main Outcome Measures:

The spontaneous nystagmus and the dynamic VOR changes were measured by the video head impulse test (VHIT) at different stages of the vertigo crisis and during the quiescent phase of the condition.

Results:

During the Ménière's attack, the VOR gain showed large changes on the affected side; however, on recovery a return to the normal value was evident. The VOR gain also showed fluctuation on follow up, paralleling symptoms. The greatest reduction of the VOR was during the paralytic nystagmus phase.

Conclusions:

The present case documents rapid vestibular fluctuation documented with VHIT testing in MD. The ionic-chemical perilymphatic intoxication and the endolymphatic space collapse due to membrane rupture could explain those features. VHIT fluctuation is a promising tool for diagnosis of patients with episodic vestibular symptoms.
Alcohol consumption and risk of gallstone disease: a meta-analysis
Authors: Wang Jiantao , Duan Xiaolin , Li Bingrong , Jiang Xiubo
Published: December 2016

Epidemiology studies have been carried out to investigate the association between alcohol consumption and the risk of gallstone disease, but the results remain controversial. We carried out a meta-analysis to quantitatively summarize the evidences from observational studies on alcohol consumption and the risk of gallstone disease. Eligible studies published in English were identified by searching PubMed, Web of Science, and Embase databases. The random-effect model was used to calculate the pooled relative risks (RRs) with 95% confidence intervals (CIs). Restricted cubic splines were used to assess the dose–response relationship. Eight cohort studies and 10 case–control studies were included in our meta-analysis. The pooled RR of gallstone disease for the highest versus the lowest alcohol consumption was 0.62 (95% CI: 0.49–0.78). Statistically significant associations were also found in stratified analysis by study design (cohort studies: RR=0.66, 95% CI: 0.48–0.91 and case–control studies: RR=0.58, 95% CI: 0.45–0.73). With respect to sex, both men (RR=0.57, 95% CI: 0.4–0.8) and women (RR=0.64, 95% CI: 0.53–0.77) showed statistically significant associations between alcohol consumption and the risk of gallstone disease. A linear dose–response relationship was found between alcohol consumption and gallstone disease risk and the risk of gallstone disease decreased by 12% (RR=0.88, 95% CI: 0.84–0.92; P
nonlinearity=0.079) for each 10 g/day increment in alcohol consumption. This meta-analysis suggests that alcohol consumption is associated with significantly decreased risk of gallstone disease.
Lactate - Arterial and Venous Agreement in Sepsis: a prospective observational study
Authors: Datta Deepankar , Grahamslaw Julia , Gray Alasdair J. , Graham Catriona , Walker Craig A.
Published: December 2016

Background

Sepsis is a common condition in the emergency department (ED). Lactate measurement is an important part of management: arterial lactate (A-LACT) measurement is the gold standard. There is increasing use of peripheral venous lactate (PV-LACT); however, there is little research supporting the interchangeability of the two measures.

If PV-LACT has good agreement with A-LACT, it would significantly reduce patient discomfort and the risks of arterial sampling for a large group of acutely unwell patients, while allowing faster and wider screening, with potential reduced costs to the healthcare system.

Objective

The aim of this study is to determine the agreement between PV-LACT and A-LACT in septic patients attending the ED.

Methods

We carried out a prospective observational cohort study of 304 consented patients presenting with sepsis to a single UK NHS ED (110 000 adult attendances annually) taking paired PV-LACT and A-LACT. Bland–Altman analysis was carried out to determine agreement. Receiver operating characteristic curves and 2×2 tables were constructed to explore the predictive value of PV-LACT for A-LACT.

Results

The mean difference (PV-LACT−A-LACT) is 0.4 mmol/l [95% confidence interval (CI): 0.37–0.45], with 95% limits of agreement from −0.4 (95% CI: −0.45 to −0.32) to 1.2 (95% CI: 1.14–1.27). A PV-LACT of at least 2 mmol/l predicts an A-LACT of at least 2 with 100% sensitivity (95% CI: 89–100%) and 83% specificity (95% CI: 77–87%).

Conclusion

This study is the largest comparing the two measurements, and shows good clinical agreement. We recommend using PV-LACT in the routine screening of septic patients. A PV-LACT less than 2 mmol/l is predictive of an A-LACT less than 2 mmol/l.
Therapy-related myeloid neoplasms
Authors: Ganser Arnold , Heuser Michael
Published: December 2016

Purpose of review

Advances in the genetic characterization of patients with therapy-related myeloid neoplasms (t-MNs) have changed our understanding of the pathogenesis of these diseases. In addition, extensive sequencing studies have identified recurrent mutations with diagnostic and prognostic impact. Thus, the revised version of the WHO classification combines therapy-related myelodysplastic syndromes (t-MDS) and therapy-related acute myeloid leukemia (t-AML) in the one entity of t-MNs because of their similar pathogenesis, rapid progression from t-MDS to t-AML, and their equally poor prognosis.

Recent findings

Fifteen percent of t-AML patients present with favorable risk fusion genes, whereas 50% have adverse cytogenetics. The most frequent molecular aberration in t-AML and t-MDS affects TP53 (33%). Selection of a pre-existing treatment-resistant hematopoietic stem cell clone with TP53 mutation has been shown as an important mechanism in the development of t-MNs and explains the high frequency of TP53 mutations in these patients. Following previous cytotoxic therapy, patients develop specific vulnerabilities, which become especially evident as high nonrelapse mortality of t-MN patients after allogeneic hematopoietic cell transplantation.

Patients are treated according to their genetic risk profile. Assessment of minimal residual disease helps to guide allogeneic transplantation for patients with favorable risk and genetic markers.
Using PCR assay for detection and subtyping of Ureaplasma parvum in women with recurrent abortion
Authors: Al-Azawi Ibtisam H. , Khaleel Sarab H. , Al-Khafaji Ghofran K.
Published: December 2016

The objectives of this study were to investigate the occurrence of Ureaplasma parvum in women with recurrent abortion and to determine the distribution of U. parvum serovars (1, 3, 6, 14) in women with recurrent abortion by conventional PCR technique. In total, 130 samples including vaginal bleeding, vaginal swab, and urine were collected from women with recurrent abortion and 40 samples including vaginal swab and urine from control women without recurrent abortion. Through the study, two types of media were used, Ureaplasma broth (IH Broth) and Ureaplasma agar (IH Agar). The positive isolates for Ureaplasma spp. were investigated by conventional PCR technique for identification of U. parvum and subtyping to their serovars (1, 3, 6, 14). The results revealed the U. parvum was identified in 29.6% from the patient group and 11% from the control group. U. parvum isolates were further subtyped using PCR, the results showed that serovar 3 was the most frequent isolate in a proportion of 42.8%, with serovar 1 (28.5%), serovar 6 (14.2%), and serovar 14 (14.2%) in the patient group, but in the control group only serovar 1 was isolated in a proportion of 11%. These results evidently indicate that U. parvum may be an important etiologic agent for recurrent abortion.
The Effectiveness of Medical Simulation in Teaching Medical Students Critical Care Medicine
Authors: Beal Matthew David , Kinnear John , Anderson Caroline Rachael , Martin Thomas David , Wamboldt Rachel , Hooper Lee
Published: December 2016

Summary Statement

We aimed to assess effectiveness of simulation for teaching medical students critical care medicine and to assess which simulation methods were most useful. We searched AMED, EMBASE, MEDLINE, Education Resources Information Centre, British Education Index, Australian Education Index, and bibliographies and citations, in July 2013. Randomized controlled trials comparing effectiveness of simulation with another educational intervention, or no teaching, for teaching medical students critical care medicine were included. Assessments for inclusion, quality, and data extraction were duplicated and results were synthesized using meta-analysis.

We included 22 randomized control trials (n = 1325). Fifteen studies comparing simulation with other teaching found simulation to be more effective [standardized mean difference (SMD) = 0.84; 95% confidence interval (CI) = 0.43 to 1.24; P < 0.001; I
2 = 89%]. High-fidelity simulation was more effective than low-fidelity simulation, and subgrouping supported high-fidelity simulation being more effective than other methods. Simulation improved skill acquisition (SMD = 1.01; 95% CI = 0.49 to 1.53) but was no better than other teaching in knowledge acquisition (SMD = 0.41; 95% CI = −0.09 to 0.91).
Eye Tracking
Authors: Henneman Elizabeth A. , Marquard Jenna L. , Fisher Donald L. , Gawlinski Anna
Published: December 2016

Introduction

Eye tracking, used to evaluate a clinician’s eye movements, is an example of an existing technology being used in novel ways by patient safety researchers in the simulated setting. The use of eye-tracking technology has the potential to augment current teaching, evaluation, and research methods in simulated settings by using this quantitative, objective data to better understand why an individual performed as he or she did on a simulated or naturalistic task.

Methods

Selected literature was reviewed with the purpose of explicating how eye tracking can be used by researchers and educators to evaluate error-prone processes. The literature reviewed was obtained by querying the databases PubMed, CINHAL, and Google Scholar using the key words eye tracking, patient safety, and medical errors from 2005 through 2015.

An introduction to the use of eye tracking, including both theoretical underpinnings and technological considerations, is presented. In addition, examples of how eye tracking has been used in research studies conducted in both simulated and naturalistic settings are provided.

Conclusions

The use of eye-tracking technology to capture the eye movements of novice and expert clinicians has provided new insight into behaviors associated with the identification of medical errors. The study of novices’ and experts’ eye movements provides data about clinician performance not possible with existing evaluation methods such as direct observation, verbal reports, and thinking out loud. The use of eye tracking to capture the behaviors of experts can lead to the development of training protocols to guide the education of students and novice practitioners. Eye-tracking technology clearly has the potential to transform the way clinical simulation is used to improve patient safety practices.
Validation of a High-Fidelity Electrophysiology Simulator and Development of a Proficiency-Based Simulator Training Program
Authors: Ullah Waqas , Hunter Ross J. , Finlay Malcolm , Earley Mark J. , McLean Ailsa , Marazzi Raffaella , De Ponti Roberto , Schilling Richard J.
Published: December 2016

Introduction

Simulator training can potentially provide high-intensity training in electrophysiology (EP) without compromising patient safety. We assessed the construct validity of a novel EP simulator (ANGIO Mentor; Simbionix) and developed proficiency-based scores for clinical EP simulator training.

Methods

Two European training centers participated. Participants were grouped on the basis of years of EP experience and (for a subset) subjectively scored clinical catheter manipulation skills. Each participant attempted the simulator's 5 modules 3 times. These modules focus on catheter manipulation in 3-dimensional models, ranging from geometric shapes to fluoroscopic contracting cardiac models, with performance scored by the system on the basis of attainment of preset targets. Using these scores, targets were formulated for basic EP training.

Results

Twenty-eight participants were included (13 with subjectively scored catheter manipulation). Scores for participants with less than 1-year EP experience (group 1) were significantly lower for each of the attempts at the modules (P < 0.002). For group 1 only, scores improved with subsequent attempts (P < 0.005). In 4 of the 5 modules, scores of group 1 were significantly lower than the more experienced groups (P < 0.0005). Participants with subjectively scored above-average catheter manipulation skills also had higher scores in 4 of the 5 modules (P < 0.05). Target scores for a proficiency-based training program were generated from the median scores for each module for those with 1-year experience or more.

Conclusions

Scores attained in the simulator can distinguish those with less than 1-year EP experience and those with above-average catheter manipulation skills. Consequently, target scores have been generated for a proficiency-based training program.
Evaluation of a Vibrotactile Simulator for Dental Caries Detection
Authors: Kuchenbecker Katherine J. , Parajon Robert C. , Maggio Margrit P.
Published: December 2016

Introduction

Developed to educate dental students in caries detection, the VerroTeach simulator allows dental faculty to share, record, and replay the tactile vibrations felt through a dental hand instrument. We assessed this simulation approach by asking experienced dental educators to evaluate the system’s real-time and video playback modes.

Methods

VerroTeach uses an accelerometer to sense instrument vibrations and a voice coil actuator to reproduce these vibrations on another tool. Seventeen dental faculty participated in the study, first experiencing real-time mode by feeling vibrations while the experimenter touched extracted teeth. The subject then experienced vibrotactile playback of 5 prerecorded caries detection tasks and 1 prerecorded caries extraction procedure, making 10 total caries judgments and repeatedly rating the system’s perceptual accuracy.

Results

Dental educators rated caries detection as significantly more difficult for students than experienced dentists (P < 0.0001), and they rated tactile feedback as a highly important source of information for this judgment. Subjects highly rated the realism of both real-time mode and playback mode. Experienced dentists performed well on the simulator, answering most questions correctly. Interestingly, nonpracticing dentists performed significantly worse than practicing dentists on the caries judgment questions (P = 0.003). Finally, subjects strongly recommended the system for training dental students.

Conclusions

These positive results indicate that sharing, recording, and replaying instrument vibrations may be beneficial for teaching caries detection to dental students. Further research is planned to improve tactile feedback quality, integrate VerroTeach into the preclinical curriculum, and explore other possible applications for this approach to clinical simulation.