Efficacy of a Smoking Cessation Intervention for Survivors of Cervical Intraepithelial Neoplasia or Cervical Cancer: A Randomized Controlled Trial.

PURPOSE: Women who smoke and have a history of cervical intraepithelial neoplasia (CIN) or cervical cancer represent a vulnerable subgroup at elevated risk for recurrence, poorer cancer treatment outcomes, and decreased quality of life. The purpose of this study was to evaluate the long-term efficacy of Motivation And Problem Solving (MAPS), a novel treatment well-suited to meeting the smoking cessation needs of this population. METHODS: Women who were with a history of CIN or cervical cancer, age 18 years and older, spoke English or Spanish, and reported current smoking (≥100 lifetime cigarettes plus any smoking in the past 30 days) were eligible. Participants (N = 202) were recruited in clinic in Oklahoma City and online nationally and randomly assigned to (1) standard treatment (ST) or (2) MAPS. ST consisted of repeated referrals to a tobacco cessation quitline, self-help materials, and combination nicotine replacement therapy (patch plus lozenge). MAPS comprised all ST components plus up to six proactive telephone counseling sessions over 12 months. Logistic regression and generalized estimating equations evaluated the intervention. The primary outcome was self-reported 7-day point prevalence abstinence from tobacco at 18 months, with abstinence at 3, 6, and 12 months and biochemically confirmed abstinence as secondary outcomes. RESULTS: There was no significant effect for MAPS over ST at 18 months (14.2% v 12.9%, P = .79). However, there was a significant condition × assessment interaction (P = .015). Follow-up analyses found that MAPS (v ST) abstinence rates were significantly greater at 12 months (26.4% v 11.9%, P = .017; estimated OR, 2.60; 95% CI, 1.19 to 5.89). CONCLUSION: MAPS led to a greater than two-fold increase in smoking abstinence among survivors of CIN and cervical cancer at 12 months. At 18 months, abstinence in MAPS declined to match the control condition and the treatment effect was no longer significant.

Evaluation of the Efficacy of a Smoking Cessation Intervention for Cervical Cancer Survivors and Women With High-Grade Cervical Dysplasia: Protocol for a Randomized Controlled Trial.

BACKGROUND: The prevalence of smoking among cervical cancer survivors is strikingly high, yet no smoking cessation interventions to date have specifically targeted this population. This paper describes the study design, methods, and data analysis plans for a randomized clinical trial designed to evaluate the efficacy of a theoretically and empirically based Motivation And Problem Solving (MAPS) approach for promoting and facilitating smoking cessation among cervical cancer survivors. MAPS is a comprehensive, dynamic, and holistic intervention that incorporates empirically supported cognitive behavioral and social cognitive theory-based treatment strategies within an overarching motivational framework. MAPS is designed to be appropriate for all smokers regardless of their motivation to change and views motivation as dynamically fluctuating from moment to moment throughout the behavior change process. OBJECTIVE: This 2-group randomized controlled trial compares the efficacy of standard treatment to MAPS in facilitating smoking cessation among women with a history of high-grade cervical dysplasia or cervical cancer. METHODS: Participants (N=202) are current smokers with a history of high-grade cervical dysplasia or cervical cancer recruited nationally and randomly assigned to one of two treatment conditions: (1) standard treatment (ST) or (2) MAPS. ST consists of repeated letters referring participants to their state's tobacco cessation quitline, standard self-help materials, and free nicotine replacement therapy when ready to quit. MAPS has all ST components along with 6 proactive telephone counseling sessions delivered over 12 months. The primary outcome is abstinence from tobacco at 18 months. Secondary outcomes include abstinence over time across all assessment points, abstinence at other individual assessment time points, quit attempts, cigarettes per day, and use of state quitlines. Hypothesized treatment mechanisms and cost-effectiveness will also be evaluated. RESULTS: This study was approved by the institutional review boards at the University of Texas MD Anderson Cancer Center, the University of Oklahoma Health Sciences Center, and Moffitt Cancer Center. Participant enrollment concluded at Moffitt Cancer Center in January 2020, and follow-up data collection was completed in July 2021. Data analysis is ongoing. CONCLUSIONS: This study will yield crucial information regarding the efficacy and cost-effectiveness of a MAPS approach for smoking cessation tailored to the specific needs of women with a history of high-grade cervical dysplasia or cervical cancer. Findings indicating that MAPS has substantially greater efficacy than existing evidence-based tobacco cessation treatments would have tremendous public health significance. TRIAL REGISTRATION: ClinicalTrials.gov NCT02157610; https://clinicaltrials.gov/ct2/show/NCT02157610. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34502.

Challenges Associated With Cervical Cancer Screening and Management in Obese Women: A Provider Perspective.

OBJECTIVES: Obese women are at increased risk of cervical cancer, partly due to missed detection of cervical precancers during routine cervical cancer screening. We administered a clinician survey to better understand specific challenges and identify potential solutions to performing cervical cancer screening and management in obese women. MATERIALS AND METHODS: We administered a web-based survey to 2,319 members of the American Society of Colposcopy and Cervical Pathology including questions related to challenges associated with cervical sampling and visualization in obese compared with normal weight women and potential strategies for improvement. We summarized providers' responses using descriptive statistics and used Fisher exact tests to evaluate associations between provider characteristics and challenges with cervical sampling, visualization, and biopsy. RESULTS: Of the 240 providers that completed the survey, 89% and 93% reported that cervical sampling and visualization are more challenging in obese women, respectively, whereas 80% reported that taking a biopsy was more challenging. Commonly reported barriers included vaginal prolapse, difficulty visualizing and accessing the cervix, and lack of long enough sampling devices and large enough speculums. Frequently used techniques to improve sampling and visualization included use of a condom or examination glove finger to sheath a speculum and using a tenaculum. Most providers identified training for cervical sampling and colposcopy in obese women as a learning gap, and only 8% reported receiving such training. CONCLUSIONS: Cervical cancer screening and management are more challenging in obese compared with normal weight women. Major barriers to cervical sampling and visualization included lack of adequately sized equipment and lack of education and training.

Experiences of women with cervical dysplasia and associated diagnoses using electronic cigarettes for smoking substitution.

INTRODUCTION: The aim of this qualitative study was to describe the motivation and experiences of women with cervical dysplasia and associated diagnoses who used electronic cigarettes (ECs) to reduce the number of cigarettes they smoked. METHODS: Qualitative interviews were conducted with 26 women aged 18-65 years with cervical dysplasia and associated diagnoses who smoked at least three cigarettes daily for the past year or more and who enrolled in an intervention designed to substitute regular cigarettes with ECs. At the 12-week follow-up, patients were contacted by telephone. Semi-structured interviews were recorded, then transcribed, coded and analysed for themes. RESULTS: When confronted with a new diagnosis associated with smoking, women in this study were eager to try ECs to help them reduce their intake of cigarettes. Women reported that physical cues similar to smoking, delivery of nicotine sufficient to assist with smoking reduction and the security of having the device available to use in instances where temptations to smoke may occur were all positive experiences in trying the device. Other women in the study reported negative experiences, such as a lack of sufficient nicotine to eliminate cravings, heaviness of the device and the need to keep it charged. Depression, nicotine addiction and habit were factors that made it difficult to decrease cigarette consumption. CONCLUSIONS: Findings suggest that ECs may help with smoking substitution in patients who must reduce smoking due to medical conditions or diagnoses.

Risk of Cervical Intraepithelial Neoplasia 2 or Worse by Cytology, Human Papillomavirus 16/18, and Colposcopy Impression: A Systematic Review and Meta-analysis.

OBJECTIVE: To calculate pooled risk estimates for combinations of cytology result, human papillomavirus (HPV) 16/18 genotype and colposcopy impression to provide a basis for risk-stratified colposcopy and biopsy practice. DATA SOURCE: A PubMed search was conducted on June 1, 2016, and a ClinicalTrials.gov search was conducted on June 9, 2018, using key words such as "uterine cervical neoplasms," "cervical cancer," "mass screening," "early detection of cancer," and "colposcopy." METHODS OF STUDY SELECTION: Eligible studies must have included colposcopic impression and either cytology results or HPV 16/18 partial genotype results as well as a histologic biopsy diagnosis from adult women. Manuscripts were reviewed for the following: cytology, HPV status, and colposcopy impression as well as age, number of women, and number of cervical intraepithelial neoplasia (CIN) 2, CIN 3, and cancer cases. Strata were defined by the various combinations of cytology, genotype, and colposcopic impression. TABULATION, INTEGRATION, AND RESULTS: Of 340 abstracts identified, nine were eligible for inclusion. Data were also obtained from three unpublished studies, two of which have since been published. We calculated the risk of CIN 2 or worse and CIN 3 or worse based on cytology, colposcopy, and HPV 16/18 test results. We found similar risk patterns across studies in the lowest risk groups such that risk estimates were similar despite different referral populations and study designs. Women with a normal colposcopy impression (no acetowhitening), less than high-grade squamous intraepithelial lesion cytology, and HPV 16/18-negative were at low risk of prevalent precancer. Women with at least two of the following: high-grade squamous intraepithelial lesion cytology, HPV16- or HPV18-positive, and high-grade colposcopic impression were at highest risk of prevalent precancer. CONCLUSION: Our results support a risk-based approach to colposcopy and biopsy with modifications of practice at the lowest and highest risk levels.

Correlation of clinical data with fallopian tube specimen immune cells and tissue culture capacity.

Human fallopian tube fimbria secretory epithelial cells (hFTSECs) are considered an origin of ovarian cancer and methods for their culture from fallopian tube specimens have been reported. Our objective was to determine whether characteristics of the donors or surgeries were associated with the capacities of fimbria specimens to generate hFTSEC cultures or their immune profiles. There were no surgical complications attributable to fallopian tube removal. Attempts to establish primary hFTSEC cultures were successful in 37 of 55 specimens (67%). Success rates did not differ significantly between specimens grouped by patient or surgery characteristics. Established cultures could be revived after cryopreservation and none became contaminated with microorganisms. Two cultures evaluated for long term growth senesced between passages 10 and 15. M1 macrophages were the predominant cell type, while all other immune cells were present at much lower percentages. IL-10 and TGF-ß exhibited opposing trends with M1 and M2 macrophages. Plasma IL-10 levels exhibited significant positive correlation with patient age. In conclusion, fallopian tube fimbria specimens exhibit a pro-inflammatory phenotype and can be used to provide a source of hFTSECs that can be cultured for a limited time regardless of the donor patient age or race, or the type of surgery performed.

Evidence-Based Consensus Recommendations for Colposcopy Practice for Cervical Cancer Prevention in the United States.

The American Society for Colposcopy and Cervical Pathology (ASCCP) Colposcopy Standards recommendations address the role of colposcopy and directed biopsy for cervical cancer prevention in the United States (US). The recommendations were developed by an expert working group appointed by ASCCP's Board of Directors. An extensive literature review was conducted and supplemented by a systematic review and meta-analysis of unpublished data. In addition, a survey of practicing colposcopists was conducted to assess current colposcopy practice in the US. Recommendations were approved by the working group members, and the final revisions were made based on comments received from the public. The recommendations cover terminology, risk-based colposcopy, colposcopy procedures, and colposcopy adjuncts. The ASCCP Colposcopy Standards recommendations are an important step toward raising the standard of colposcopy services delivered to women in the US. Because cervical cancer screening programs are currently undergoing important changes that may affect colposcopy performance, updates to some of the current recommendations may be necessary in the future.

ASCCP Colposcopy Standards: Risk-Based Colposcopy Practice.

OBJECTIVES: The American Society for Colposcopy and Cervical Pathology (ASCCP) Colposcopy Standards recommendations address the role of and approach to colposcopy for cervical cancer prevention in the United States. MATERIALS AND METHODS: The recommendations were developed by an expert working group appointed by ASCCP's Board of Directors. This article describes the rationale, evidence, and recommendations related to risk-based colposcopy practice. RESULTS: Women referred to colposcopy have a wide range of underlying precancer risk, which can be estimated by referral screening tests including cytology and human papillomavirus testing, in conjunction with the colposcopic impression. Multiple targeted biopsies, at least 2 and up to 4, are recommended to improve detection of prevalent precancers. At the lowest end of the risk spectrum, untargeted biopsies are not recommended, and women with a completely normal colposcopic impression can be observed. At the highest end of the risk spectrum, immediate treatment is an alternative to biopsy confirmation. CONCLUSIONS: Assessing the risk of cervical precancer at the colposcopy visit allows for modification of colposcopy procedures consistent with a woman's risk. Implementation of these recommendations is expected to lead to improved detection of cervical precancers at colposcopy, while providing more reassurance of negative colposcopy results.

Comparison of Colposcopic Impression Based on Live Colposcopy and Evaluation of Static Digital Images.

OBJECTIVE: The aim of the study was to evaluate the agreement and compare diagnostic accuracy of colposcopic impressions from live colposcopy versus evaluation of static digital images. MATERIALS AND METHODS: Live impressions and corresponding static images obtained during colposcopy of 690 women were independently compared. Diagnostic accuracy was calculated for colposcopic impressions from both methods, varying hypothetical thresholds for colposcopically directed cervical biopsies (acetowhitening or worse, low grade or worse, high grade or worse). Stratified analyses investigated the impact of referral cytology, human papillomavirus 16 infection, and age on colposcopic impression. RESULTS: Overall agreement between live and static colposcopic visualization was 43.0% (κ = 0.20; 95% CI = 0.14-0.26) over normal, acetowhitening, low-grade, and high-grade impressions. Classification of acetowhitening or worse impressions showed the highest agreement (92.2%; κ = 0.39; 95% CI = 0.21-0.57); both methods achieved more than 95% sensitivity for CIN 2+. Agreement between live and static colposcopic visualization was 69.3% for rating low-grade or worse impressions (κ = 0.23; 95% CI = 0.14-0.33) and 71% when rating high-grade impressions (κ = 0.33; 95% CI = 0.24-0.42). Live colposcopic impressions were more likely to be rated low grade or worse (p < .01; odds ratio = 3.5; 95% CI = 2.4-5.0), yielding higher sensitivity for CIN 2+ at this threshold than static image assessment (95.4% vs 79.8%, p < .01). Overall, colposcopic impressions were more likely rated high grade on live assessment among women referred with high-grade cytology (odds ratio = 3.3; 95% CI = 1.8-6.4), significantly improving the sensitivity for CIN 2+ (66.3% vs 48.5%, p < .01). CONCLUSIONS: Colposcopic impressions of acetowhitening or worse are highly sensitive for identifying cervical precancers and reproducible on static image-based pattern recognition.

Adherence to physical activity guidelines in mid-pregnancy does not reduce sedentary time: an observational study.

BACKGROUND: Physical activity (PA) interventions designed to prevent prenatal complications have focused on increasing moderate PA yielding conflicting results. Minimal attention has focused on the evaluation of sleep, sedentary behavior (SB), light activity or total daily PA during pregnancy. The purpose of this prospective, longitudinal study was to 1) objectively quantify and compare habitual PA and SB during the 2nd and 3rd trimester; and 2) evaluate differences in activity patterns for women meeting prenatal PA guidelines versus those that did not. METHODS: Forty-six participants wore 2 PA monitors (SenseWear Mini and activPAL) during week 18 and week 35 of pregnancy. We compared differences in sleep duration, postural allocation, daily steps, and PA between the 2nd and 3rd trimester and for women who met and did not meet PA guidelines. RESULTS: During the 2(nd) trimester, 30% of the women's day (24-hours) was total sleep; 52% SB; 13% light; 3% moderate; and 0% vigorous PA. Light (P = 0.05), vigorous (P = 0.02), and moderate-vigorous PA (MET-minutes; P = 0.02), decreased with a trend in increased SB (P = 0.07). Activity of other intensities and sleep duration did not significantly change. Only 39% and 37% of participants slept between 7-9 hours/night at week 18 and 35, respectively. Forty-six percent (n = 21) and 28% (n = 13) of participants met prenatal PA guidelines during the 2(nd) and 3(rd) trimester, respectively. At week 18, no differences in total sleep, SB, or light PA existed for women who met PA guidelines versus those who did not; total PA was significantly greater for women who met guidelines. At week 35, women that met PA guidelines had significantly less SB (P < 0.005) than women who did not. CONCLUSIONS: This study demonstrates that pregnant women spend the majority of their day in SB. Significant reductions in total activity across pregnancy may be attributed, in part to shifts in light PA and increased SB. Based on the lifestyle of our sample, regardless of meeting PA guidelines in mid-pregnancy, no significant difference exists in time spent in SB, however meeting PA recommendations in late pregnancy may reduce SB. Future interventions should target reducing SB by increasing light and moderate PA beyond volitional exercise.

MDDScore: confirmation of a blood test to aid in the diagnosis of major depressive disorder.

BACKGROUND: Previously, a biomarker panel was developed for use as an aid to major depressive disorder (MDD) diagnosis; it consisted of 9 biomarkers associated with the neurotrophic, metabolic, inflammatory, and hypothalamic-pituitary-adrenal axis pathways. This panel and associated algorithm produced good clinical sensitivity and specificity (92% and 81%, respectively) in differentiating MDD patients from individuals without MDD. To further validate the panel, we performed a prospective study using a larger set of new prospectively acquired MDD patients and a similarly collected population of nondepressed subjects. The addition of gender and body mass index (BMI) effects to the algorithm was also evaluated. METHOD: Blood samples were obtained from MDD patients (n = 68) clinically evaluated at multiple sites in 2011 and 2012 using standard psychiatric assessment tools and structured clinical interviews according to DSM-IV criteria. Blood samples (n = 86) from nondepressed subjects were obtained as controls. MDD and nondepressed samples were randomized into independent training (n = 102) and validation sets (n = 52). Analytes in sera were quantified by immunoassay. RESULTS: Training set biomarker data were used to develop a logistic regression model that included gender and BMI in a manner that allowed for their interaction with the biochemical analytes. For the training set, the sensitivity and specificity of the test (with 95% CI) were 93% (0.80-0.98) and 95% (0.85-0.99), respectively. This method (designated the MDDScore) was then applied to the independent validation set and had a sensitivity and specificity of 96% (0.77-0.98) and 86% (0.66-0.95), respectively. The overall accuracy for the training set was 94%; the validation set accuracy was 91%. CONCLUSION: Examination of a randomized independent set of samples confirms the ability of the previously established biomarker panel to identify persons with MDD; the accuracy was over 90%. The improved model that adds gender and BMI to the previously established panel of 9 biomarkers is robust and simple; it provides the most rigorously tested, objective diagnostic test for MDD to date.

Multiple biopsies and detection of cervical cancer precursors at colposcopy.

PURPOSE: Women with abnormal cervical cancer screening results are referred to colposcopy and biopsy for diagnosis of cervical cancer precursors (high-grade squamous intraepithelial lesions [HSILs]). Colposcopy with a single biopsy can miss identification of HSILs. No systematic study has quantified the improved detection of HSIL by taking multiple lesion-directed biopsies. METHODS: The Biopsy Study was an observational study of 690 women referred to colposcopy after abnormal cervical cancer screening results. Up to four directed biopsies were taken from distinct acetowhite lesions and ranked by colposcopic impression. A nondirected biopsy of a normal-appearing area was added if fewer than four directed biopsies were taken. HSIL identified by any biopsy was the reference standard of disease used to evaluate the incremental yield and sensitivity of multiple biopsies. RESULTS: In the overall population, sensitivities for detecting HSIL increased from 60.6% (95% CI, 54.8% to 66.6%) from a single biopsy to 85.6% (95% CI, 80.3% to 90.2%) after two biopsies and to 95.6% (95% CI, 91.3% to 99.2%) after three biopsies. A significant increase in sensitivity of multiple biopsies was observed in all subgroups. The highest increase in yield of HSIL was observed for women with a high-grade colposcopic impression, HSIL cytology, and human papillomavirus (HPV) type 16 positivity. Only 2% of all HSILs diagnosed in the participants were detected by biopsies of normal-appearing transformation zone. CONCLUSION: Collection of additional lesion-directed biopsies during colposcopy increased detection of histologic HSIL, regardless of patient characteristics. Taking additional biopsies when multiple lesions are present should become the standard practice of colposcopic biopsy.

Evaluation of clinical performance of a novel urine-based HPV detection assay among women attending a colposcopy clinic.

BACKGROUND: Human papillomavirus (HPV) testing in urine offers a convenient approach for cervical cancer screening but has previously suffered from limited clinical sensitivity. OBJECTIVES: We evaluated clinical performance of the prototype Trovagene HPV test, a novel polymerase chain reaction assay that targets the E1 region of the HPV genome and detects and amplifies short fragments of cell-free HPV DNA in urine. STUDY DESIGN: We conducted a pilot study among 72 women referred to colposcopy following abnormal screening. Participants provided a urine sample prior to clinician-collected cervical sampling and colposcopically-directed punch biopsy. Trovagene HPV test results on urine samples were compared with cervical and urine testing by Linear Array HPV Genotyping Test (LA-HPV) for detection of histologically-confirmed cervical precancerous lesions. RESULTS: There was high concordance between urine samples tested by the Trovagene HPV test and corresponding cervical (87.5%) and urine (81.9%) samples tested by LA-HPV. The Trovagene HPV test had high sensitivity (92.3% for detecting CIN2/3, and 100% for CIN3), comparable to LA-HPV testing on cervical samples (96.0% and 100%, respectively), and higher than LA-HPV testing on urine samples (80.8% and 90.0%, respectively). In this referral population, the specificity of the Trovagene urine HPV test was non-significantly lower (29% for CIN2/3 and 25% for CIN3) than corresponding estimates of LA-HPV testing on cervical (36% and 28%, respectively) and urine (42% and 38%, respectively) samples. CONCLUSIONS: This pilot study suggests that the Trovagene HPV test has high sensitivity for urine-based detection of cervical precancer and merits evaluation in larger studies.

Physical activity during pregnancy: impact of applying different physical activity guidelines.

Multiple guidelines and definitions of physical activity (PA) have been used to study the benefits of activity during pregnancy. The different guidelines lead to a wide range of prevalence estimates and this has led to conflicting reports about activity patterns during pregnancy. A longitudinal study was conducted to assess PA using a pattern-recognition monitor for a 7-day period at week 18 (n = 55) and week 35 (n = 66) of pregnancy. The amount of activity performed and the number of women meeting six different PA guidelines were evaluated. Adherence to PA guidelines ranged from 5 to 100% and 9 to 100% at weeks 18 and 35, respectively. All women achieved the 500 MET-minute guideline and nearly all women accumulated ≥150 minutes of weekly moderate-vigorous physical activity (MVPA) at both time points. Only 22% and 26% participated in ≥3 sessions of MVPA lasting ≥30 minutes at both time points and this further declined to 5% and 9% when the guideline was increased to ≥5 sessions of 30 minutes. The amount of PA during pregnancy varied drastically depending on which guideline was used. Further research is warranted to clearly identify the patterns of activity that are associated with healthy pregnancy outcomes.

The diagnosis of depression: current and emerging methods.

Depression is one of the leading causes of disability in adolescents and adults, particularly starting from age 15 years and older. Diagnosis of depression has traditionally been made based on clinical criteria, including patient current symptoms and history. This process is widely used but relies on subjective interpretation. To standardize both the data obtained and data interpretation, various interview-based instruments and noninterview methods exist for screening and testing for depression in various clinical settings. This article evaluates the technical basis for and clinical performance of these various instruments and methods to diagnosis depression in clinical settings. Traditional tools include physician-administered or patient self-administered interview tools that have reasonable clinical accuracy depending on the threshold score and may lead to a full diagnostic evaluation for high-risk patients. In addition, older laboratory methods such as the dexamethasone test have contributed to the diagnosis of depression over a long period. Newer diagnostic methods such as genomics, proteomics, and metabolomics are technically sophisticated and objective and are beginning to emerge in psychiatry. Although promising, further evaluation of these methods is needed to fully demonstrate their clinical value and accuracy.

Validity of the SenseWear® Armband to predict energy expenditure in pregnant women.

UNLABELLED: Few valid, objective methods exist to quantify physical activity and predict energy expenditure (EE) during pregnancy. PURPOSE: The purpose of this study was to evaluate the validity of the SenseWear Mini armband monitor (SWA) (BodyMedia, Pittsburgh, PA) to estimate EE in pregnant women. METHODS: Thirty healthy pregnant women (22-24 wk of gestation) completed a series of activities of daily living (typing, laundry, sweeping, and treadmill walking: 2.0, 2.5, 3.0, and 3.0 mph, 3% incline) while EE was estimated by the SWA and measured by indirect calorimetry (IC). The SWA data were processed using both the v2.2 algorithm and the newer v5.2 algorithm. The estimated EE values were compared with the measured EE values using a three-way (method × algorithm × activity) mixed model ANOVA. Least square means ± SE were estimated in the model. Significance was set at P < 0.05. RESULTS: The analyses revealed a significant method (IC vs. SWA) × algorithm (v5.2 vs. v2.2) interaction with significantly smaller error (IC-SWA) for the newer v5.2 algorithm (-0.57 ± 0.06 kcal.min(-1)) than the older v2.2 algorithm (-0.78 ± 0.06 kcal.min(-1)). The SWA significantly overestimated EE for all activities, except inclined walking. The average mean absolute percentage error was considerably lower for the new algorithm (22%) than that for the older algorithm (35%). The average individual correlation coefficients revealed good overall agreement between the SWA and the IC (v5.2, mean r = 0.93; v2.2, mean r = 0.87). CONCLUSION: Overall, the SWA correlated well with IC; however, EE was significantly overestimated during most activities. Future studies should develop pregnancy-specific algorithms and assess validity of the SWA at all stages of pregnancy to further improve prediction of EE in this population.

Accuracy of physical activity assessment during pregnancy: an observational study.

BACKGROUND: Prenatal physical activity may improve maternal and infant health and lower future disease risk for both mother and baby; however, very few physical activity assessment methods have been validated for use during pregnancy. The purpose of this study was to evaluate the accuracy of a subjective physical activity record (PAR) and an objective activity monitor, against a reference standard to quantify moderate and vigorous physical activity (MVPA) in pregnant women. The reference standard was based on participant interviews to determine if a woman was an exerciser and confirmed with information obtained from the PAR and a heart rate monitor. METHODS: Fifty-two pregnant women completed a physical activity record (PAR) and wore a SenseWear® Mini Armband (SWA) activity monitor over a 7-day period at 18 weeks gestation. Total minutes spent in MVPA were totaled from both modalities and evaluated against the reference standard using contingency analysis and Pearson's chi-square test to evaluate the number of women meeting minimum prenatal physical activity recommendations (at least 3, 30 minute sessions of exercise per week). Both modalities were also tested individually and collectively to assess their ability as indicators of activity using empirically determined cut-offs as indicated by receiver-operator characteristic curves. These experimentally-derived criteria were also tested with Pearson's chi-square test. RESULTS: According to the reference standard, 13 of 52 participants (25%) met the criterion of 3, 30 minute sessions of volitional, moderate-intensity activity. When compared to the reference standard, both the PAR and SWA overestimated exercise status; 42 (81%) and 52 (100%) participants, respectively, achieved 90 minutes of MVPA (P < 0.0001 for both comparisons). Single-modality predictors of MVPA did not show a significant correlation. A composite predictor of MVPA offered the most favorable option for sensitivity and specificity (true positives, n = 8 and true negatives, n = 36) using cut-offs of 280 and 385 minutes/week for the PAR and SWA, respectively. CONCLUSION: Compared to the reference standard, time spent in MVPA obtained from the PAR or SWA overestimated the prevalence of women meeting prenatal exercise recommendations. The most accurate predictor of women meeting current prenatal exercise guidelines was identified by using the PAR and SWA collectively.

Incorporation of a decorin biomimetic enhances the mechanical properties of electrochemically aligned collagen threads.

Orientational anisotropy of collagen molecules is integral to the mechanical strength of collagen-rich tissues. We have previously reported a novel methodology to synthesize highly oriented electrochemically aligned collagen (ELAC) threads with mechanical properties approaching those of native tendon. Decorin, a small leucine-rich proteoglycan (SLRP), binds to fibrillar collagen and has been suggested to enhance the mechanical properties of tendon. Based on the structure of natural decorin, we have previously designed and synthesized a peptidoglycan (DS-SILY) that mimics decorin both structurally and functionally. In this study, we investigated the effect of the incorporation of DS-SILY on the mechanical properties and structural organization of ELAC threads. The results indicated that the addition of DS-SILY at a molar ratio of 30:1 (collagen:DS-SILY) significantly enhanced the ultimate stress and ultimate strain of the ELAC threads. Furthermore, differential scanning calorimetry revealed that the addition of DS-SILY at a molar ratio of 30:1 resulted in a more thermally stable collagen structure. However, addition of DS-SILY at a higher concentration (10:1 collagen:DS-SILY) yielded weaker threads with mechanical properties comparable to collagen control threads. Transmission electron microscopy revealed that the addition of DS-SILY at a higher concentration (10:1) resulted in pronounced aggregation of collagen fibrils. More importantly, these aggregates were not aligned along the long axis of the ELAC, thereby compromising the overall tensile properties of the material. We conclude that incorporation of an optimal amount of DS-SILY is a promising approach to synthesize mechanically competent collagen-based biomaterials for tendon tissue engineering applications.

Monochorionic diamniotic twins concordant for anencephaly: a case report.

BACKGROUND: Anencephaly occurs in 1.4-4.7 per 10,000 deliveries and is thought to result from failed closure of the anterior neuropore at 24-26 days post fertilization. Among twins, risk for congenital malformations is greatest among monozygotic twins. Several occurrences of twin pairs being discordant for neural tube defects have been reported: 1 twin affected with anencephaly and co-twin affected with holoprosencephaly, spina bifida or encephalocele, is consistent with a multifactorial pattern of inheritance. We present an instance of monochorionic diamniotic twins concordant for anencephaly. CASE: An 18-year-old, gravida 1, para 0, Caucasian woman presented with monochorionic diamniotic twin gestation at 22 weeks. Prenatal ultrasound identified polyhydramnios, anencephaly, ventricular septal defect and suspected rocker-bottom feet in twin A. Twin B was identified as anencephalic, with left renal agenesis and spinal distortion visualized on ultrasound. Postnatal cytogenetic evaluations of placenta, umbilical cord blood and fetal skin samples from both twins revealed 46,XX karyotypes. CONCLUSION: A rare case of a monochorionic diamniotic gestation concordant for anencephaly is presented. Previously published reports of concordant twin anencephaly have postulated a possible autosomal recessive or multifactorial mode of inheritance. Subsequent pregnancies with anencephaly or other open neural tube defects would indicate a mendelian process.