A case-control study of breast cancer among Japanese women: with special reference to family history and reproductive and dietary factors

Summary To study the effects of family history and reproductive, anthropometric, and dietary factors on the risk of breast cancer among low risk populations, we conducted a hospital-based case-control study involving 908 patients with breast cancer and their matched controls, in Japan. A positive family history of breast cancer significantly increased the risk of breast cancer (odds ratio = 1.52, 95% confidence interval: 1.14–2.03). The risk further increased with increasing number of family members affected. Obesity, single marital status, fewer births, a late childbirth, and less consumption of green-yellow vegetables and dairy products were also associated with an increased risk of breast cancer. These associations were independent in multivariate analyses. There was no increase in risk associated with consumption of high fat foods. When analyzed by menopausal status, the association with family history of breast cancer, especially in the first degree of relatives, was more evident for premenopausal breast cancer. The associations with obesity and lower consumption of dairy products were more pronounced for postmenopausal breast cancer, while those with lower parity and single marital status were stronger for premenopausal breast cancer.     

An observational study of cholecystectomy in patients receiving tegaserod.

BACKGROUND: Registrational studies of patients treated with tegaserod for irritable bowel syndrome (IBS) suggest an increased risk for cholecystectomy versus treatment with placebo. OBJECTIVE: To study cholecystectomy rates in association with tegaserod within a large administrative medical claims database. METHODS: Patients were drawn from a large population within the US with commercial medical insurance. The primary analysis consisted of a comparison of the observed incidence rate for cholecystectomy claims among a large cohort of new-to-therapy tegaserod users with an incidence rate published for tegaserod-naive patients classified with IBS within the same insured population. RESULTS: An inception cohort of 7475 individuals with up to 103 weeks of claims history following initiation of therapy with tegaserod was identified. After a follow-up of 3 months (and thus similar to the longest registrational trials), the observed cholecystectomy incidence rate was 340 per 10,000 person-years (95% CI 258, 442). The rate of cholecystectomy was highest in the earliest months of observation following initiation of tegaserod. The observed cholecystecomy incidence rate is 2.9 times higher than an IBS-specific rate of 119 per 10,000 person-years as published for patients so classified within the same insured population. CONCLUSION: Based on a large, inception cohort, we report a strong temporal association between the initiation of tegaserod therapy and an increased rate for cholecystectomy. The effect size at 3 months was similar to the relative risk for cholecystectomy reported in registrational studies comparing tegaserod with placebo. As misclassification of initial diagnosis for patients presenting with biliary colic-like symptoms may occur, precise measurements of tegaserod-related relative risk for cholecystectomy from observational studies are problematic and will require prospective studies.     

Dental abnormalities in individuals with pathogenic germline variation in DICER1

Pathogenic germline variation in the microRNA processing gene DICER1 gives rise to an autosomal dominant, tumor‐predisposition disorder. Conditional deletion of Dicer1 in murine dental epithelium shows that it controls tooth patterning, size, number, and shape. The human dental phenotype of people with germline pathogenic variation in DICER1 is unknown. DICER1‐carriers (n = 57) and family controls (n = 55) were evaluated at the NIH Clinical Center dental clinic as part of a comprehensive medical evaluation. Digital panoramic radiographs, bite‐wing radiographs, and oral photographs were collected. A single observer, blind to DICER1 status, reviewed the dental records and determined the presence or absence of 11 dental characteristics as described in the clinic notes, radiographs, or oral photographs. Subjective phenotypes were reviewed on radiographs by two examiners (blind to DICER1 status) for the presence or absence of the dental characteristics to reduce inconsistencies. By simple association, bulbous crown, periodontitis, and taurodontism were all significant (p < .05). Logistic regression with chi‐square maximum likelihood estimates showed that bulbous crown and periodontitis remained significant. Recognition of these phenotypes may aid identification of individuals and families at risk for DICER1‐associated neoplasms. These findings may also guide dental care for individuals with germline DICER1 pathogenic variation.     

Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 Explanation and Elaboration: A Report of the ISPOR CHEERS II Good Practices Task Force

Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces the previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, and the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as healthcare, public health, education, and social care). This Explanation and Elaboration Report presents the new CHEERS 2022 28-item checklist with recommendations and explanation and examples for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer-reviewed journals and the peer reviewers and editors assessing them for publication. Nevertheless, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, given that there is an increasing emphasis on transparency in decision making.     

The History and Future of the “ISPOR Value Flower”: Addressing Limitations of Conventional Cost-Effectiveness Analysis

ObjectivesSince its publication as part of the 2018 ISPOR Special Task Force (STF) on US Value Assessments, the “ISPOR value flower,” with its petals highlighting elements that may be overlooked or underappreciated in conventional drug value assessments, has been discussed and debated. We review the history of the value flower, describe recent developments, and consider implications for future value assessments.MethodsWe discuss various antecedents to the value flower, as well as conceptual and empirical articles published in the past 4 years.ResultsSince the publication of the ISPOR STF report, researchers have provided more rigorous theoretical and mathematical foundations for certain novel value elements (eg, severity of illness, value of insurance, value of hope) through “generalized risk-adjusted cost-effectiveness analysis,” which incorporates risk aversion in people’s preferences and uncertainty in treatment outcomes. Empirical estimates are also emerging to support key elements, such as insurance value, real option value, value of hope, and value of knowing. Although health technology assessment bodies have applied or are considering certain elements (eg, severity modifiers to cost-effectiveness thresholds), other elements have yet to gain traction.ConclusionsFive years after the STF began its work, the development of novel value measures continues to evolve. Although it is encouraging to see supporting empirical studies emerging, more are needed. Additional efforts are also needed to illustrate how the estimates can be used in the deliberative processes that are integral to health technology assessments.     

Penetration moxibustion for postpartum subinvolution of uterus: Two case reports and mechanism analysis: 透灸法成功治疗产后子宫复旧不良:两则病例报告及机制分析

This article introduced the application of penetration moxibustion in successfully treating two cases of postpartum subinvolution of uterus. The main complaint of one case was increasing volume of abnormal vaginal bleeding for five days after delivery. The bleeding stopped after the patient received 7 times treatment of warming needle and penetration moxibustion on Zhōngjí (中极CV3), Guānyuán (关元CV4) and Qìhăi (气海CV6). The other case complained about persistent abdominal pain for 15 days, which was worsening for the recent 2 days. The symptom of abdominal pain was relieved after the penetration moxibustion was applied on CV4, CV6 and Zǐgōng (子宫 EX-CA1) for 5 times for the case. Penetration moxibustion can relieve abdominal pain during the postpartum period, accelerate lochia discharge, and recovery of menstrual and uterine cavity. Àiyè (艾叶 Artemisiae Argyi Folium) was proved to have antibacterial, hemostatic, and analgesic effects. The warming function and radiation features of moxibustion can help to alleviate spasm of the smooth muscle in the uterus and enhance the metabolism of the uterine tissue by expanding microvessels and improving the circulations of both blood and lymph. It can also activate cells in the uterine tissue by increased temperature in order to enhance the decomposition and elimination of pathological wastes, such as inflammation and hematoma. In addition, it can also relieve pelvic pain by inhibiting neuronal excitability.     

Nutrition Claims on Fruit Drinks Are Inconsistent Indicators of Nutritional Profile: A Content Analysis of Fruit Drinks Purchased by Households With Young Children

BackgroundFruit drinks are the most commonly consumed sugar-sweetened beverage among young children. Fruit drinks carry many nutrition-related claims on the front of package (FOP). Nutrition-related claims affect individuals’ perceptions of the healthfulness of products and purchase intentions, often creating a “health halo” effect.ObjectiveThe aims of this study were to describe the prevalence of FOP nutrition-related claims on fruit drinks purchased by households with young children and to examine the association between claims and the nutritional profile of fruit drinks.DesignThe sample included 2059 fruit drinks purchased by households with children 0 to 5 years old participating in Nielsen Homescan in 2017. FOP labels were obtained from 2 databases that contain bar code–level information on all printed material on product labels. A codebook was used to code for presence of FOP nutrition-related claims. The coded claims data were linked by bar code with Nutrition Facts label data. Claim type prevalence was calculated, and the association between claim types and median calories and total grams of sugar per 100 mL was analyzed using Wilcoxon rank-sum tests. The percentages of products containing noncaloric sweeteners (NCSs) with and without each claim type were also calculated and compared.ResultsAlmost all (97%) fruit drinks sampled had at least 1 nutrition-related FOP claim. Implied natural claims such as “natural flavors” were the most common (55% of products), followed by claims about the presence of juice or nectar (49%). Claims about vitamin C (33%), sugar (29%), and calories (23%) were also common. Fruit drinks with vitamin C, juice or nectar, fruit or fruit flavor, and overt natural claims were higher in calories and sugar and less likely to contain NCSs compared with products without these claims. Fruit drinks with calorie, sugar, NCS, implied natural, and other claims were lower in calories and sugar and more likely to contain NCSs compared with products without these claims.ConclusionsClaims are prevalent on fruit drinks purchased by households with young children. This is concerning given prior research demonstrating that claims can mislead consumers. Regulatory actions such as requiring a warning or disclosure on drinks that contain added sugars or NCSs should be considered.     

Strengthening the Evidence for Maternal and Child Health: Implementing the New Performance Measurement Framework for the Title V Maternal and Child Health Block Grant

Maternal and Child Health Journal - The Health Resources and Services Administration’s Maternal and Child Health Bureau (HRSA MCHB) developed a three-tiered performance measure framework for...