I need assistance in my Annotated Bibliography. Please review the PDFs attached for all the information related to the assignment. My main topic for the AB is Trisomy 21 and the effect it has on peopl

Prenatal screening .

Screening .

Trisomy 21 .

Patient education .

Genetic counseling .

Informed consent .

Health literacy Introduction Trisomy 21, also known as Down syndrome, is a chromosom- al abnormality that is associated with intellectual disability and congenital anomalies (Wilson et al. 2015). The risk of chromosomal abnormalities inc reases with maternal age (Roizen and Patterson 2003). However, using age alone is unacceptable compared with current screening options for assessing the risk of aneuploidies (Chitayat et al. 2011).

There are seven screening options available in Canada with various sensitivities and false positive rates that inform pa- tients as to whether or not they are at an increased risk of carrying a fetus with Trisomy 21 (Chitayat et al. 2011). Four of these seven screening options are available to the present study population at Mount Sinai Hospital (Toronto, ON): first trimester screening (FTS), integrated prenatal screening (IPS), maternal serum screening (MSS), and non-invasive prenatal testing (NIPT). The timing and components of these tests can be found in Table 1. NIPT has been found to have the greatest sensitivity (>98%) and lowest false positive rate (<1%) of all of the screening options offered, however, most Canadian patients must pay for this test out of pocket (Norton et al.

2015 ; Swanson et al. 2013; Willems et al. 2014). Prenatal screening is highly utilized in Ontario, Canada with 80.3% of women choosing to receive screening between December 2007 and November 2009 (Hayeems et al. 2015).

As the screening tests are optional, and given the signifi- cant implications and decision making that occur after a pos- itive screen result, informed consent is a necessary component of care prior to undergoing screening (Alderson 2001). *Amanda Selk [email protected] Michal Sheinis [email protected] Kira Bensimon [email protected] 1 Faculty of Medicine, University of Toronto, 1 King ’s College Circle, Toronto, ON M5S 1A8, Canada 2 Department of Obstetrics & Gynaecology, Mount Sinai Hospital, 600 University Avenue, Toronto, ON M5G 1X5, Canada 3 Department of Obstetrics & Gynaecology, University of Toronto, 123 Edward Street, Suite 1200, Toronto, ON M5G 1E2, Canada 4 700 University Avenue, 3rd floor, Toronto, ON M5G 1Z5, Canada J Genet Counsel (2018) 27:95 –103 DOI 10.1007/s10897-017-0126-3 Various investigators have shown that the proportion of wom- en making an informed choice to undergo prenatal screening ranges from 37% to 75.5% (Rowe et al.2006; Schoonen et al.

2012 ;vandenBergetal. 2005). Demographic characteristics such as older age (Schoonen et al. 2012) and being of a certain ethnicity (Dormandy et al. 2005; Fransen et al. 2010), as well as social determinants of health such as higher educational level (Rowe et al. 2006) have been correlated with higher rates of informed decision making. Other social determinants of health such as health literacy- the ability of a person to under- stand and interpret health information- have not been studied in this field although they have been shown to relate to health outcomes (Safeer and Keenan 2005).

In Canada, most prenatal care and counseling is provided by obstetricians (Born Ontario 2016). The most recent quan- titative Canadian study of prenatal screening knowledge in women followed by physicians for obstetrical care was carried out almost 20 years ago, at which time only maternal serum screening was available (Goel et al. 1996). Since then, many more screening tests have been developed, most of which are available at an earlier gestational age than maternal serum screening, allowing women who choose to terminate their pregnancy the opportunity to do so earlier. Maternal age is increasing with >18% of women being >age 35 in Canada in 2007 compared to 10% in 1993 (Public Health Agency of Canada 2013). Although Trisomy 21 incidence increases with maternal age, the birth prevalence has remained stable in the past 20 years due to an increase in the number of terminations of pregnancy as a result of more accurate screening (Public Health Agency of Canada 2013). Access to abortions is poor in non-urban areas of Canada, abortion providers are concen- trated in urban areas, and there are few providers that provide access to second trimester procedures (Norman et al. 2016).

Given the evolution of prenatal screening, the important ethical considerations involved, and a lack of recent studies examining women ’s knowledge of this area, the timing is right for such a study to be carried out. Thus, this study sought to assess pregnant women ’s level of knowledge about Trisomy 21 screening at a single Canadian urban academic centre to determine any links between their level of knowledge and factors such as age, socioeconomic status, nature of counsel- ing, and health literacy. Methods Participants and Procedures Ethical approval was obtained from the Research Ethics Board at Mount Sinai Hospital (14 –0312-E). A convenience sample of participants was recruited by research assistants in the waiting area of an obstetrical ultrasound clinic at Mount Sinai Hospital. Participants completed the survey prior to their ultrasound appointments. All data was collected between January 2015 and June 2015. Both low and high-risk obstet- rics patients were eligible to participate regardless of gesta- tional age. Patients who did not speak English and patients of the principal investigator were ineligible. With the exception of the health literacy assessment, the survey was self-admin- istered. Written consent was obtained from patients prior to completing the survey.

Instrumentation A cross-sectional survey was developed to assess pregnant women ’s knowledge of Trisomy 21 and associated screening tests. The survey included three components: demographic data and other prenatal care information, a health literacy as- sessment, and a screening knowledge assessment.

The demographic and prenatal care information section was created solely for this study. Demographic data collected included age, employment, marital status, education, income, ethnic origin, country of birth, and first language. Prenatal care data included type of obstetrical care provider, prenatal screening choices, and the n ature of prenatal screening counseling (if any). The Trisomy 21 knowledge assessment Ta b l e 1 Prenatal screening test available at the study site Test Timing of administration Components of the test First trimester screening (FTS) 11 –13 + 6 weeks -Nuchal translucency (NT) -Pregnancy Associated Plasma Protein A (PAPP-A) -Free-beta subunit of human Chorionic Gonadotropin ( βhCG) Integrated prenatal screening (IPS) 11 –13 + 6 weeks 15 –20 + 6 weeks -NT and PAPP-A -Alpha-fetoprotein (AFP) -human Chorionic -Gonadotropin (hCG) -Unconjugated estriol (uE3) -Dimeric Inhibin-A (DIA) Maternal serum screening (MSS) 15 –20 + 6 weeks -AFP -hCG -uE3 -DIA Non-invasive prenatal testing (NIPT) After 10 weeks Circulating cell free DNA (ccfDNA)).

96 Sheinis, Bensimon and Selk was completed with the use of a previously validated tool created by Schoonen et al. (2011) that includes 12 questions to assess multiple knowledge domains including purpose of screening, interpretation of screening results, screening proce- dures, and understanding of Trisomy 21. This tool was de- signed to cover domains important in counseling regarding the combined IPS test, but all information is also applicable to the screening options available to all patients in this study.

Health literacy was measured with the use of the Newest Vital Sign tool that was previously validated (Weiss et al. 2005)due to the known association between health literacy and knowl- edge of various kinds of health information (Safeer and Keenan 2005). The survey was pilot tested on 10 people of varying educational backgrounds to ensure clarity and com- prehension of questions and to estimate the time required for completion. In accordance with Schoonen et al. ( 2012) women with a score of >60% were deemed to have adequate knowledge about prenatal screening and the disorder for which screening was being conducted. In accordance with Weiss et al. ( 2005), women receiving a score of at least 66% on the health literacy assessment were deemed to have a high degree of health literacy.

Data Analysis Because fetal Trisomy 21 becomes more common with in- creasing maternal age, it was hypothesized that older women were more likely to be counseled with regards to prenatal screening and therefore more likely to have higher knowledge scores. A power calculation determined that a sample size of 126 with 63 in each group (< and Q35 years of age) was required to achieve a power of 80% to detect a minimum 8% difference between the groups with respect to knowledge of Trisomy 21 risks with a two-sided α-value of 0.05.

Independent sample t-tests were used to compare mean scores on the knowledge test with age and health literacy. Multiple linear regression was performed to determine whether there was a link between adequate knowledge of prenatal screening and sociodemographic variables or health literacy. Pearson ’s chi square tests were used to compare adequate knowledge with categorical data. All data analyses were carried out using SPSS Version 22.

Results A total of 243 women were approached to participate and after exclusions a total of 139 surveys were completed. Among completed surveys, a further four patients were excluded due to prenatal counseling received outside of Canada (therefore irrelevant to the current study) or due to age not being provid- ed (a variable of significant interest to study investigators). A total of 135 surveys (response rate 55.6%) were included in the final analysis. As outlined in Table 2, most of the women were employed (85.2%), in a married or common law rela- tionship (92.6%), and had an annual household income >$49,999 (85.9%). Most of the women (91.9%) had some degree of post-secondary education. As shown in Table 3, 96.3% of the women in our sample had undergone some form of prenatal screening in the current pregnancy. The majority of women had received information about screening which they reported as answering yes to the question BDid you receive counseling on prenatal screening? ^ (71.9%) with the most frequent source of information being obstetricians alone (33%). Most of the women (69.6%) were able to indicate the screening test they had completed. While 26.7% knew they had undergone screening, they could not specify which test they had. Of those who indicated the timing of their counseling/receiving information about screening, 10.2% of women had received counseling only after having blood drawn for screening purposes. The most common screening test used was FTS alone (28.1%) and the least com- mon was NIPT (ccfDNA) alone (1.5%). The knowledge score averaged for all participants was 7 out of 10. The majority of women (74.2%) had adequate knowledge of Trisomy 21 and screening procedures (scored >6/10 on the knowledge questionnaire). The answers to the knowledge questionnaire are shown for the 129/135 women who fully completed that part of the assessment (in Table 4).

Almost one third of women (29.5%) did not know that the screening test was optional (question 12). Of those whose responses to this question were incorrect, 21/37 (57%) report- ed that they had received counseling. Of the 12 questions, question 3 ( BAll children with Down syndrome are mentally handicapped ^) received the lowest frequency of correct re- sponses (36.4%), while question 11 ( BThe result of prenatal screening for Down syndrome may lead to difficult choices ^) received the highest frequency of correct responses (93.8%). Multiple linear regression was performed and found that multiparity and counseling were the only factors that positive- ly and significantly correlated with knowledge scores while first language other than English was negatively and signifi- cantly correlated with knowledge scores. These variables accounted for 22% of the variance in knowledge scores (Table 5). Discussion This study found that although the rate of adequate knowledge about Trisomy 21 and related screening pro- cedures was fairly high in this population (74.2%), many women were not counseled, and many women were unaware that prenatal screening is an optional test.

Though prior counseling correlated with greater Patients ’Knowledge of Prenatal Screening for Trisomy 21 97 Ta b l e 2Characteristics of participants Overall (n =135) Younger age < 35 years ( n =68) Older age ≥35 years ( n =67) P -value Mean (SD) Mean (SD) Mean (SD) Age in years 34.3 (4.37) 30.9 (3.02) 37.7 (2.56) <0.001*** n (%) n (%) n (%) Employment 0.5 Full-time student 3 (2.2%) 2 (2.9%) 1 (1.5%) Employed full-time 103 (76.3%) 53 (77.9%) 50 (74.6%) Employed part-time 12 (8.9%) 5 (7.4%) 7 (10.4%) Unemployed 11 (8.1%) 4 (5.9%) 7 (10.4%) Mixed 5 (3.7%) 4 (5.9%) 1 (1.5%) No response 1 (0.7%) 0 (0%) 1 (1.5%) Marital status 0.48 Married 106 (78.5%) 54 (79.4%) 52 (77.6%) Single 9 (6.7%) 6 (8.8%) 3 (4.5%) Common law 19 (14.1%) 8 (11.8%) 11 (16.4%) Divorced 1 (0.7%) 0 (0%) 1 (1.5%) Highest education 0.93 High school or less 11 (8.1%) 6 (8.8%) 5 (7.5%) Post secondary certificate/diploma 24 (17.8%) 13 (19.1%) 11 (16.4%) University Bachelor ’s degree 51 (37.8%) 24 (35.3%) 27 (40.3%) Postgraduate Masters or higher 49 (36.3%) 25 (36.8%) 24 (35.8%) Annual household income <0.001*** $0 –$49,999 16 (11.9%) 14 (20.6%) 2 (3.0%) $50,000 –$99,999 35 (25.9%) 12 (17.6%) 23 (34.3%) $100,000 –$149,999 34 (25.2%) 22 (32.4%) 12 (17.9%) >$150,000 47 (34.8%) 18 (26.5%) 29 (43.3%) No response 3 (2.2%) 2 (2.9%) 1 (1.5%) Country of birth 0.66 Canada 95 (70.4%) 49 (72.1%) 46 (68.7%) Other 38 (28.1%) 18 (26.5%) 20 (29.9%) No response 2 (1.5%) 1 (1.5%) 1 (1.5%) First official language 0.64 English 106 (78.5%) 54 (79.4%) 52 (77.6%) Other 22 (16.3%) 10 (14.7%) 12 (17.9%) No response 7 (5.2%) 4 (5.9%) 3 (4.5%) Language spoken most often at home 0.18 English 114 (84.4%) 59 (86.8%) 55 (82.1%) Other 15 (11.1%) 5 (7.4%) 10 (14.9%) No response 6 (4.4%) 4 (5.9%) 2 (3.0%) First pregnancy 0.003** Yes 55 (40.7%) 36 (52.9%) 19 (28.4%) No 78 (57.8%) 31 (45.6%) 47 (70.1%) No response 2 (1.5%) 1 (1.5%) 1 (1.5%) Gestational age at time of survey 25.5 (9.13) 23.3 (9.17) 27.6 (8.62) <0.001*** Median (Range) Median (Range) Total number of pregnancies 1 (1 –7) 2 (1 –7) 0.02* Total number of births over 20 weeks 0 (0 –4) 0 (0 –4) 0.21 98 Sheinis, Bensimon and Selk knowledge, sociodemographic factors and health literacy were not shown to relate to knowledge with the excep- tion of a positive correlation with multiparity and a negative correlation with first language other than English. These findings are in agreement with studies demonstrating a correlation between language and knowledge (Fransen et al. 2010) but in contrast to pre- vious studies showing that factors such as ethnicity, ed- ucation, and income correlate with knowledge (Dormandy et al. 2005; Gourounti and Sandall 2008).

However, these studies were carried out with different knowledge measures and in different populations with one study having a far larger sample size (Dormandy et al. 2005) and another study not conducting a multi- variate regression in their st atistical analysis (Gourounti and Sandall 2008). It is unclear if multiparous women may have been counseled in a previous pregnancy or if their increased knowledge comes from other sources.

Counseling has been shown to increase the number of women who make informed choices regarding prenatal screening (Lewis et al. 2015).

Compared to other populations studied (Rowe et al.

2006; van den Berg et al. 2005; Gourounti and Sandall 2008), a greater proportion of this study ’s sample had adequate knowledge of Trisomy 21 screening.

Strikingly, 29.5% of the women were not aware of the optional nature of the test, findings which are supported by a recent study showing that the majority of counsel- ing conversations do not emphasize the importance of personal choice in undergoing screening (Colicchia et al. 2016). Though 71.9% of the women had under- gone counseling, many women (10.2%) underwent screening blood tests prior to being counseled with regards to the nature of th e test and the implications of the results. In addition 57% of women who did not know that testing was optional reported that they had received some sort of Bcounselling ^which was clearly inadequate. Given the consequences of a positive result of a screening test and the necessary involvement of the patient with regards to accepting or declining a confir- matory test, the large proportion of uncounseled women is concerning.

This survey of women receiving prenatal care from both physicians and midwives is the first study of Canadian women to be published since 1996; and the characteristics previously found to correlate with knowledge (e.g. greater age, higher education, being Canadian-born, and higher income; Goel et al. 1996) were not shown to relate to adequate knowledge 21 years later. Both the Goel et al. study and the present study were carried out in the same province (Ontario, Canada), but the number of prenatal screening tests available has increased greatly over that time period and the populations sampled are very different with regards to variation in sociodemographic characteristics which may explain this discrepancy (Lepage et al. 2012). Testing options have increased along with counseling complexity. For each test offered, discussion now includes review of specificity and sensitivity as well as test cost and criteria for coverage (Benn and Chapman 2016). Just as significant, however, has been the changing social land- scape with regard to ethical perspectives on prenatal screening and views on disability and pregnancy termination (Higuchi et al. 2016; Steinbach et al. 2016). Modern screening has expanded to be not just about pregnancy termination but also for preparation for those choose to continue the pregnancy (de Jong et al. 2015).

Though formal genetic counseling models focus on inte- grating complete clinical information with patient values to achieve proper informed consent (Canadian Association of Genetic Counsellors 2017), for this study ’s participants and for most patients, this conversation falls to their obstetricians, midwives, or family doctors who do not have the resources to conduct such in depth discussions (Colicchia et al. 2016).

From an ethical perspective, non-directive and sufficiently in formative counseling is necessary to preserve the autonomy of the patient (Chitayat et al. 2011). The routine use of screen- ing and increased availability, though meant to increase Ta b l e 2 (continued) Overall (n =135) Younger age < 35 years ( n =68) Older age ≥35 years ( n =67) P -value Mean (SD) Mean (SD) Mean (SD) Number of live children 0 (0 –4) 0 (0 –4) 0.21 Number of weeks when you first saw your obstetrical care provider 8(3 –20) 8 (1 –20) 0.68 Number of weeks when you saw any care provider 6(2 –12) 6 (0 –12) 0.62 Statistical significance demonstrated with independent sample T-tests *Statistically significant at p< 0.05.

**Statistically significant at p<0.01.

***Statistically significant at p<0.001.

Patients ’Knowledge of Prenatal Screening for Trisomy 21 99 women’s autonomy, can impose pressure on the patient to choose to screen, thereby reducing the probability of informed decisions (Alderson 2001; Seavilleklein 2009; Suter 2002).

The more routine the screening procedure and the greater the availability, the more crucial the counseling process becomes (Wray et al. 2005). As non-invasive prenatal screening tech- nology advances and is applied to a greater number of disor- ders, patient counseling will become increasingly complex as women will be asked to consider for which disorders they want testing. Ethical challenges will arise regarding social considerations of which disorders are significant enough to desire an abortion and the impact of these changing perspec- tives on individuals with these disorders currently living in our society (de Jong et al.

2010).

Study Limitations As this survey was administered with a convenience sample, some degree of selection bias may have been introduced, thus affecting the results. In addition, the interpretation of the Ta b l e 3 Screening choice and nature of counseling n(%) Type of screening n=135 FTS only 38 (28.1%) IPS only 29 (21.5%) NIPT only 2 (1.5%) Don ’t know what screening is 2 (1.5%) Doing screening, but don ’t know which 36 (26.7%) IPS + NIPT 10 (7.4%) FTS + NIPT 15 (11.1%) No response 3 (2.2%) Did you receive counseling? Yes 97 (71.9%) No 34 (25.2%) Missing 4 (3%) Timing of counseling with respect to screening blood work n=127 Before blood work 55 (43.3%) After blood work 13 (10.2%) Not sure 22 (17.3%) Not applicable 37 (29.1%) Who provided counseling? n=97 Family physician 21 (21.6%) Midwife 2 (2.1%) Obstetrician 32 (33%) Genetics 9 (9.3%) Fertility physician 3 (3.1%) Registered nurse 2 (2.1%) Mix 28 (28.9%) Gestational age when first received counseling (weeks) Mean (SD) 9.7 (3.74) What type of counseling? (more than 1 answer allowed) n (%) Audio 5 (5.2%) Oral 87 (89.7%) Pamphlet 35 (36.1%) Prenatal screening clinic 22 (22.7%) Vid eo 11 (11 .3 %) We b s i t e 8 ( 8 . 2 % ) Other 5 (5.2%) No response 5 (5.2%) 100 Sheinis, Bensimon and Selk knowledge-based survey questions may be subjective and re- sponses to the questions relied on the participants’recollection.

Using the statement "All children with Down Syndrome are mentally handicapped" may have been misinterpreted, as many parents of children with Down Syndrome might not describe their children as Bmentally handicapped^ ,butmerelyBdelayed^, or having a Blearning disability ^. The number of participants incorrectly answering that statement may be an underestimate if this question was misinterpreted. The response rate was mod- erate at 55.6%. Finally, this study was carried out in a single urban academic centre, limiting the generalizability of the results.Practice Implications The correlation of lower knowledge levels with having a first language other than English points towards a necessity for more targeted and individualiz ed counseling strategies.

Having medical interpreters available may be beneficial.

Furthermore, the fact that 28.1% of participants were not counseled at all and that 29.5% lacked awareness with regards to the optional nature of the test demonstrate that current counseling is insufficient. Studies have already shown that face-to-face delivery of prenatal screening counseling is Ta b l e 4 Proportion of correct responses on knowledge assessment by question n=129 n(%correct responses) Q1. The probability that your child has Down syndrome can be determined through prenatal screening in the early stages of pregnancy. (Yes) 118 (91.5%) Q2. The probability that an unborn child has Down syndrome is generally very slight (less than 1%). (Yes) 55 (42.6%) Q3. All children with Down syndrome are mentally handicapped. (Yes) 47 (36.4%) Q4. Heart defects in children with Down syndrome can generally be treated effectively. (Yes) 52 (40.3%) Q5. The combined test (IPS or FTS) consists of a measurement of the thickness of the nuchal fold of the unborn child (a nuchal ultrasound) and a blood test on the mother. (Yes) 112 (86.8%) Q6. Should the result of the combined test be unfavorable, this means that the child has Down syndrome. (No) 103 (79.8%) Q7. Should the result of the combined test be favorable, the child may still prove to have Down syndrome when born. (Yes) 93 (72.1%) Q8. Amniocentesis or chorionic villus sampling may induce a miscarriage. (Yes) 96 (74.4%) Q9. Both amniocentesis and chorionic villus sampling provide certainty about the presence of Down syndrome in an unborn child. (Yes) 79 (61.2%) Q10. Should Down syndrome be diagnosed during the first four months of pregnancy, it is possible for a pregnant woman to terminate the pregnancy. (Yes) 107 (82.9%) Q11. The result of prenatal screening for Down syndrome may lead to difficult choices. (Yes) 121 (93.8%) Q12. Prenatal screening for Down syndrome is compulsory for every pregnant woman in Canada. (No) 91 (70.5%) wrong response and BIdon ’tknow ^both considered incorrect Ta b l e 5 Results of multiple linear regression of predictors of knowledge of Trisomy 21 and associated screening procedures Variables Estimate Standard Error t-value p-value Gestational Age (at survey) −0.04 0.02 −1.720 0.089 Maternal Age <0.01 0.06 0.054 0.957 Employment 0.26 0.18 1.389 0.168 Marital status 0.18 0.21 0.854 0.395 Education 0.54 0.29 1.885 0.062 Income 0.28 0.26 1.058 0.292 Ethnicity 0.18 0.14 1.3335 0.185 Country of Birth −0.23 0.62 −0.377 0.707 First Language −1.79 0.67 −2.689 0.008** Number of births > 20 weeks 0.30 0.14 2.141 0.035* Previous Counseling 1.57 0.49 3.196 0.002** Health Literacy 0.46 0.72 0.645 0.520 ( R 2=0.38, F= 5.0, df=12, p<0.001).

*Statistically significant at p<0.05.

**Statistically significant at p<0.01. Patients ’Knowledge of Prenatal Screening for Trisomy 21 101 superior to online delivery (Willis et al.2015). As well, infor- mation presented in audio format is least positively received (Willis et al. 2015). New prenatal counseling tools and deci- sion aids that are created need to incorporate this information regarding varying patient needs while trying to meet patient preferences for face-face delivery of information to address these gaps in knowledge accordingly (Portocarrero et al.

2015 ). Decision aids will need to be translated and tested in different languages. Though multiparity and first language other than English are non-modifiable factors that correlate with knowledge, re- ceipt of counseling, which was shown to correlate positively with adequate knowledge, is within the health care provider ’s control. Prenatal care providers and developers of prenatal screening decision aids should be aware of these factors to improve counseling strategies for populations more likely to have inadequate knowledge. Although providing counseling to 100% of women may not be realistic given that not all patients have access to genetic counselors and health care providers have many conflicting interests to balance, this should be the goal to ensure informed consent.

Research Recommendations As the number of screening options for Trisomy 21 increase, the information that needs to be conveyed becomes more complex. Research is required to develop, test, and implement high quality decision aids to help patients make informed choices in the increasingly complex area of prenatal screening.

Acknowledgements This work was supported by the Generalist Division, Department of Obstetrics and Gynaecology, Mount Sinai Hospital and the University of Toronto, Department of Obstetrics and Gynaecology for summer students to finish study recruitment. The funders had no involvement in the study design; collection, analysis, and interpretation of data; writing of the report; or decision to submit the article for publication.

Compliance with Ethical Standards Funding This work was supported by the Generalist Division, Department of Obstetrics and Gynaecology, Mount Sinai Hospital and the University of Toronto, Department of Obstetrics and Gynaecology for summer students to finish study recruitment. The funders had no involve- ment in the study design; collection, analysis, and interpretation of data; writing of the report; or decision to submit the article for publication.

Conflict of Interest The authors declare that they have no conflict of interest.

Ethical Approval This study received research ethics board approval from Mount Sinai Hospital (14 –0312-E).

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