Folic Acid Supplementation for the Prevention of Neural Tube Defects: An Updated Evidence Report and Systematic Review for the US Preventive Services Task Force

AB Importance: Neural tube defects are among the most common congenital anomalies in the United States. Periconceptional folic acid supplementation is a primary care-relevant preventive intervention. Objective: To review the evidence on folic acid supplementation for preventing neural tube defects to inform the US Preventive Services Task Force for an updated Recommendation Statement. Data Sources: MEDLINE, Cochrane Library, EMBASE, and trial registries through January 28, 2016, with ongoing surveillance through November 11, 2016; references; experts. Study Selection: English-language studies of folic acid supplementation in women. Excluded were poor-quality studies; studies of prepubertal girls, men, women without the potential for childbearing, and neural tube defect recurrence; and studies conducted in developing countries. Data Extraction and Synthesis: Two investigators independently reviewed abstracts, full-text articles, and risk of bias of included studies. One investigator extracted data and a second checked accuracy. Because of heterogeneity, data were not pooled. Main Outcomes and Measures: Neural tube defects, harms of treatment (twinning, respiratory outcomes). Results: A total of 24 studies (N > 58 860) were included. In 1 randomized clinical trial from Hungary initiated in 1984, incidence of neural tube defects for folic acid supplementation compared with trace element supplementation was 0% vs 0.25% (Peto odds ratio [OR], 0.13 [95% CI, 0.03-0.65]; n = 4862). Odds ratios from cohort studies recruiting participants between 1984 and 1996 demonstrated beneficial associations and ranged from 0.11 to 0.27 (n = 19 982). Three of 4 case-control studies with data from 1976 through 1998 reported ORs ranging from 0.6 to 0.7 (n > 7121). Evidence of benefit led to food fortification in the United States beginning in 1998, after which no new prospective studies have been conducted. More recent case-control studies drawing from data collected after 1998 have not demonstrated a protective association consistently with folic acid supplementation, with ORs ranging from 0.93 to 1.4 and confidence intervals spanning the null (n > 13 990). Regarding harms, 1 trial (OR, 1.40 [95% CI, 0.89-2.21]; n = 4767) and 1 cohort study (OR, 1.04 [95% CI, 0.91-1.18]; n = 2620) found no statistically significant increased risk of twinning. Three systematic reviews found no consistent evidence of increased risk of asthma (OR, 1.06 [95% CI, 0.99-1.14]; n = 14 438), wheezing, or allergy. Conclusions and Relevance: In studies conducted before the initiation of food fortification in the United States in 1998, folic acid supplementation provided protection against neural tube defects. Newer postfortification studies have not demonstrated a protective association but have the potential for misclassification and recall bias, which can attenuate the measured association of folic acid supplementation with neural tube defects. Copyright 2017 by the American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use. American Medical Association, 515 N. State St, Chicago, IL 60610

Psychometric Evaluation and Design of Patient-Centered Communication Measures for Cancer Care Settings

Objective To evaluate the psychometric properties of questions that assess patient perceptions of patient-provider communication and design measures of patient-centered communication (PCC). Methods Participants (adults with colon or rectal cancer living in North Carolina) completed a survey at 2 to 3 months post-diagnosis. The survey included 87 questions in six PCC Functions: Exchanging Information, Fostering Health Relationships, Making Decisions, Responding to Emotions, Enabling Patient Self-Management, and Managing Uncertainty. For each Function we conducted factor analyses, item response theory modeling, and tests for differential item functioning, and assessed reliability and construct validity. Results Participants included 501 respondents; 46% had a high school education or less. Reliability within each Function ranged from 0.90 to 0.96. The PCC-Ca-36 (36-question survey; reliability=0.94) and PCC-Ca-6 (6-question survey; reliability=0.92) measures differentiated between individuals with poor and good health (i.e., known-groups validity) and were highly correlated with the HINTS communication scale (i.e., convergent validity). Conclusion This study provides theory-grounded PCC measures found to be reliable and valid in colorectal cancer patients in North Carolina. Future work should evaluate measure validity over time and in other cancer populations. Practice implications The PCC-Ca-36 and PCC-Ca-6 measures may be used for surveillance, intervention research, and quality improvement initiatives

Translating Medical Evidence to Promote Informed Health Care Decisions: Decision Making about PSA

To examine the effects of a community-based intervention on decisions about prostate-specific antigen (PSA) screening using multiple measures of informed decision making (IDM)

Partnership as a means for reaching special populations: evaluating the NCI's CIS Partnership Program

The National Cancer Institute's (NCI's) Cancer Information Service (CIS) Partnership Program involves collaboration with over 900 organizations and coalitions serving minority and medically underserved populations. Cancer Information Service collaborations are categorized into three types: networking, educational program, and program development partnerships. A survey of CIS partnership organizations (n = 288). Most respondents reported that partnerships with CIS are collaborative and make good use of their organization's skills and resources, and most perceive that the benefits of partnership outweigh any drawbacks. More than one-quarter say partnerships have not done a good job evaluating collaborative activities. Results vary among three types of partnerships. Evaluation of the CIS Partnership Program presents an opportunity to examine how a large-scale and multi-faceted partnership effort has been implemented, how it is evaluated, and initial indicators of program success. Organizations, health professionals, and community leaders interested in effective partnerships can use these findings to strengthen collaborations and maximize outcomes

41 COVID-19 vaccination in cancer patients receiving chemotherapy: does vaccination increase the risk of hypersensitivity reactions?

Objectives: Hypersensitivity reactions (HSRs) to chemotherapy are one of the leading causes of death due to drug-induced anaphylaxis. Several studies have described HSRs to the various COVID-19 vaccines. This study aims to determine the risk of a HSR among chemotherapy patients who have received the COVID-19 vaccination, by examining if there is a difference in frequency of HSRs to chemotherapeutic agents among patients who have been vaccinated against COVID-19 compared to patients who have not been vaccinated. Methods: This was a retrospective cohort study performed via chart review. Inclusion criteria were all patients receiving any type of chemotherapy at a cancer center between 2018 and 2021. Patients less than 18 years old were excluded. The frequency of patients with one or more episodes of HSRs to chemotherapeutic agents were compared between patients who have received at least one dose of vaccination against COVID-19 to patients who did not receive the vaccination. Incidence proportions of HSRs, relative risk of HSR along with 95% confidence limits, and chi-square based two tailed P-value were reported to compare the differences between the two groups. Results: A total of 1,310 patients were included in the study. There were 531 (41%) patients in the COVID-19 vaccinated group and 778 (59%) in the unvaccinated group. In the vaccinated cohort, the incidence proportion of an HSR after one or more chemotherapy infusions was 1.13%. The incidence proportion in the unvaccinated cohort was 1.03%. Compared to unvaccinated patients, the relative risk of HSR to chemotherapy in vaccinated patients was 1.099 (95% CI = 0.384–3.149). These results indicate that there was a non-significant difference in HSRs between the vaccinated and unvaccinated cohorts (P=0.867). Conclusions: COVID-19 vaccination does not appear to increase the risk of HSRs in chemotherapy recipients. It is essential to continue to ensure the safety and tolerance of COVID-19 vaccines among populations at risk of increased mortality from COVID-19 disease, including cancer patients. This study adds to a body of evidence seeking to analyze and understand potential side effects associated with COVID-19 vaccination. A proposed area of further investigation is to analyze the incidence proportion of HSRs to chemotherapy among patients who have been vaccinated with different types of COVID-19 vaccines