Transparency and the Food and Drug Administration—A Quantitative Study

In Europe and North America, there is increasing political pressure being put on health regulatory agencies to become more transparent. To date, however, there has been little academic evaluation—let alone analysis—of these transparency initiatives from a risk communication perspective. This review examines whether the U.S. Food and Drug Administration's Adverse Event Reporting System quarterly signal postings, put in place after the passage of the Food and Drug Administration Amendments Act 2007, will assist patients and doctors in their decision-making processes, on the basis of results of a quantitative Internet survey of 433 physicians and 1,000 American adults. The results indicate that there is significant disagreement between physicians and the public about when medical safety issues should be communicated in the first place, with physicians opposed to early signal postings while the public in general is in favor. In addition the findings show that if the public were to find their drugs listed on the Adverse Event Reporting System signals web postings, more than a quarter would stop taking their medicine. Going forward, the Food and Drug Administration needs to work to a greater degree with social scientists in developing scientific-based communication strategies, rather than developing transparency initiatives on the basis of stakeholder consultations.     

Stability of indicators of the metabolic syndrome from childhood and adolescence to young adulthood: the Québec Family Study

The stability of indicators of the metabolic syndrome from childhood and adolescence to young adulthood was examined. The sample included 76 males and 71 females measured between the ages of 8 and 18 years and again as young adults (12 year follow-up). Indicators included the sum of three trunk skinfolds (SF3), mean blood pressure (MBP), and fasting blood glucose (GLY), high-density lipoprotein cholesterol (HDL-C), ratio of total cholesterol to HDL-C (CHOL/HDL), and triglycerides (TG). The indicators were subjected to principal components analysis to obtain a composite risk factor index (RFI). Partial interage correlations, controlling for initial age and length of follow-up, were 0.70 and 0.50 for SF3, 0.40 and 0.54 for MBP, 0.58 and 0.56 for HDL-C, 0.51 and 0.57 for CHOL/HDL, 0.37 and 0.20 (NS) for TG, 0.30 and 0.14 (NS) for GLY, and 0.51 and 0.46 for the RFI, in males and females, respectively. The results indicate that indicators of the metabolic syndrome are moderately stable from childhood and adolescence into young adulthood.     

Obesity Can Benefit Survival—A 9-Year Prospective Study in 1614 Chinese Nursing Home Residents

ObjectiveWeight loss has been considered predictive of early mortality in nursing home residents. Lower body mass index, irrespective of weight loss, has also been considered detrimental for survival in community-dwelling older persons. We examined which of the 2 is more important for survival in nursing home residents and at what body mass index (BMI) cut-offs survival benefits are gained or lost.DesignProspective study.SettingNursing homes.ParticipantsOne thousand six-hundred fourteen nursing home residents.MeasurementMinimum Data Set at baseline and mortality status assessed at 6 months, 1, 2, 4, and 9 years later. Relationship between mortality and significant weight loss (≥5% over 30 days or ≥10% over 180 days), and BMI, was studied by Cox regression with both variables in the same model, adjusted for age, sex, medical conditions (cancer, renal failure, heart disease, dementia, hip fracture, diabetes mellitus), tube-feeding, 25% food left uneaten, swallowing problem, and the activities of daily living hierarchy scale.ResultsOne thousand six-hundred fourteen residents (69.5% female) with mean age 83.7 ± 8.4 years and mean BMI 21.7 ± 4.8 were studied. Mortality rates were 6.3% (6-month), 14.3% (1-year), 27.1% (2-year), 47.3% (4-year), and 78.1% (9-year). Significant weight loss was not associated with higher mortality at all follow-up durations, whereas higher BMI was significantly protective: mortality reduction per 1 unit increase in BMI were 9% at 6 months, 10% at 1 year, 9% at 2 years, 7% at 4 years, and 5% at 9 years, all at P < .001. Having ≥25% of food left uneaten (51.2% of participants) had no relationship to survival at all follow-up durations. At 9 years, compared with those with BMI < 18.5kg/m², the normal weight (BMI 18.5–22.9 kg/m², Asia Pacific cut-off), overweight (BMI 23–25 kg/m², Asia Pacific cut-off) and obese (BMI > 25 kg/m², Asia Pacific cut-off) had significantly lower mortality (hazard ratio 0.65, 0.62, and 0.47, respectively, all P < .001).ConclusionsSignificant weight loss as defined by the Minimum Data Set was not associated with short- or long-term survival in Chinese nursing home residents. BMI, however, is predictive of short- and long-term survival irrespective of weight loss in this population. Low BMI, detectable at a single point of time, may be another readily available alternative trigger point for possible interventions in reducing mortality risk. Obese residents had the lowest mortality compared with those with normal weight.     

Nursing Home Residents’ Functional Trajectories and Mortality After a Transfer to the Emergency Department

ObjectiveTo describe nursing home residents’ (NHRs) functional trajectories and mortality after a transfer to the emergency department (ED).DesignCase-control observational multicenter study.Setting and ParticipantsIn total, 1037 NHRs presenting to 17 EDs in France over 4 nonconsecutive weeks in 2016.MethodsFinite mixture models were fitted to longitudinal data on activities of daily living (ADL) scores before transfer (time 1), during hospitalization (time 2), and within 1 week after discharge (time 3) to identify groups of NHRs following similar functional evolution. Factors associated with mortality were investigated by Cox regressions.ResultsTrajectory modeling identified 4 distinct trajectories of ADL. The first showed a high and stable (across time 1, time 2, and time 3) functional capacity around 5.2/6 ADL points, with breathlessness as the main condition leading to transfer. The second displayed an initial 37.8% decrease in baseline ADL performance (between time 1 and time 2), followed by a 12.5% recovery of baseline ADL performance (time 2?time 3), with fractures as the main condition. The third displayed a similar initial decrease, followed by a 6.7% recovery. The fourth displayed an initial 70.1% decrease, followed by an 8.5% recover, with more complex geriatric polypathology situations. Functional decline was more likely after being transferred for a cerebrovascular condition or for a fracture, after being discharged from ED to a surgery department, and with a heavier burden of distressing symptoms during transfer. Mortality after ED transfer was more likely in older NHRs, those in a more severe condition, those who were hospitalized more frequently in the past month, and those transferred for cerebrovascular conditions or breathlessness.Conclusions and ImplicationsIdentified trajectories and factors associated with functional decline and mortality should help clinicians decide whether to transfer NHRs to ED. NHRs with high functional ability seem to benefit from ED transfers whereas on-site alternatives should be sought for those with poor functional ability.     

Prenatal exposure of the northern Québec Inuit infants to environmental contaminants.

The Inuit population residing in Nunavik (northern Québec, Canada) relies on species from the marine food web for subsistence and is therefore exposed to high doses of environmental contaminants such as polychlorinated biphenyls and methylmercury and to a lesser extent lead. In view of the neurotoxic properties of these substances following developmental exposure, we initiated a study on infant development in this remote coastal population. Here we report the magnitude of prenatal exposure to these contaminants and to selective nutrients in Inuit mothers and their newborns who were recruited on the Hudson Bay coast. We conducted interviews during the women's pregnancies and at 1 and 11 months postpartum and collected biological samples for mercury, lead, polychlorinated biphenyls (PCBs), and chlorinated pesticides analyses as well as selenium and N-3 polyunsaturated fatty acids (n3-PUFA). Cord blood, maternal blood, and maternal hair mercury concentrations averaged 18.5 microg/L, 10.4 microg/L, and 3.7 microg/g, respectively, and are similar to those found in the Faroe Islands but lower than those documented in the Seychelles Islands and New Zealand cohorts. Concentrations of PCB congener 153 averaged 86.9, 105.3, and 131.6 microg/kg (lipids) in cord plasma, maternal plasma, and maternal milk, respectively; prenatal exposure to PCBs in the Nunavik cohort is similar to that reported in the Dutch but much lower than those in other Arctic cohorts. Levels of n3-PUFA in plasma phospholipids and selenium in blood are relatively high. The relatively low correlations observed between organochlorine and methylmercury concentrations may make it easier to identify the specific developmental deficits attributable to each toxicant. Similarly, the weak correlations noted between environmental contaminants and nutrients will facilitate the documentation of possible protective effects afforded by either n3-PUFA or selenium against neurotoxic contaminants.     

Segregation analysis of body mass index in an unselected French-Canadian sample: the Québec Family Study

Interest in a single gene etiology for obesity, as assessed by the body mass index (BMI), has been spurred recently by reports of a putative recessive major gene for extreme values, which accounts for as much as 40% of the variance. The major gene hypothesis was evaluated here in the Québec Family Study, a random sample of 375 French-Canadian volunteer families. This report represents one component in a more complete investigation of obesity in these families. In contrast to the recent studies, a major gene hypothesis for BMI was not verified here. Although there was a major effect, it did not conform to a Mendelian pattern of transmission. A multifactorial component (i.e., polygenic and/or common environmental factors) accounted for 42% of the phenotypic variance. In addition, evidence of heterogeneity between the generations was found. The heterogeneity was traced to the major non-Mendelian component (which accounted for 0.01% of the variance in parents and over 40% in offspring) rather than to the multifactorial one. These results would suggest that a simple recessive gene mixed model may not be sufficient to explain the familial distribution of the BMI. Several factors which may have contributed to these results include temporal trends and surrogate effects such as those related to variation in body composition and energy balance components.     

“A Bone of Contention…”: Perceived Barriers and Situational Dependencies to Food Preferences of Nursing Home Residents

Abstract

This study investigated barriers to fulfilling food preferences from nursing home (NH) residents’ perspectives, and the reasons preferences changed (situational dependencies). Interviews were completed with 255 residents in 28 NHs across greater Philadelphia, PA using six food items from the Preferences for Everyday Living Inventory-NH (PELI-NH). Participants were predominantly white (77%), female (67.8%), and widowed (44%) with high school educations (48%). Content analysis was used to identify n?=?386 barriers and n?=?57 situational dependencies. Participants reported provider policies and staff proficiency as environmental barriers to preference fulfillment regarding what, when, and where to eat. Perceived health and personal resources were barriers to obtaining snacks, take-out, and dining out. Situational dependencies resulted from residents’ perceived health and quality of family relationships. Results have implications for providers to centralize food preference fulfillment in care planning, and to use food preferences to address dining quality concerns.     

Institutional Factors Associated with Residents’ Malnutrition in Nursing Homes: A Cross-Sectional Study

ObjectivesMalnutrition is frequent in older adults, associated with increased morbidity, mortality, and higher costs. Nursing home residents are especially affected, and evidence on institutional factors associated with malnutrition is limited. We calculated the prevalence of malnutrition in Swiss nursing home residents and investigated which structure and process indicators of nursing homes are associated with residents’ malnutrition.DesignSubanalysis of the Swiss Nursing Homes Human Resources Project 2018, a multicenter, cross-sectional study conducted from 2018 to 2019 in Switzerland.Setting and ParticipantsThis study included 76 nursing homes with a total of 5047 residents.MethodsMalnutrition was defined as a loss of bodyweight of ≥5% in the last 30 days or ≥10% in the last 180 days. Binomial generalized estimating equations (GEE) were applied to examine the association between malnutrition and structural (staffing ratio, grade mix, presence of a dietician, malnutrition guideline, support during mealtimes) and process indicators (awareness of malnutrition, food administration process). GEE models were adjusted for institutional (profit status, facility size) and specific resident characteristics.ResultsThe prevalence of residents with malnutrition was 5%. A higher percentage of units per nursing home having a guideline on prevention and treatment of malnutrition was significantly associated with more residents with weight loss (OR 2.47, 95% CI 1.31-4.66, P = .005). Not having a dietician in a nursing home was significantly associated with a higher rate of residents with weight loss (OR 1.60, 95% CI 1.09-2.35, P = .016).Conclusions and ImplicationsHaving a dietician as part of a multidisciplinary team in a nursing home is an important step to address the problem of residents’ malnutrition. Further research is needed to clarify the role of a guideline on prevention and treatment of malnutrition to improve the quality of care in nursing homes.     

An exploratory investigation of genetic linkage with body composition and fatness phenotypes: the Québec Family Study

In the present investigation, we have attempted to identify regions of the genome in which "obesity genes" potentially reside using robust sib-pair linkage analysis. Data were collected on 1,628 individuals in 301 nuclear families residing in the environs of Québec City during the period 1978-1981. In addition to traditional blood group antigens and enzyme polymorphisms, several phenotypes in the obesity domain that are associated with increased morbidity were assessed, including measures relating to heaviness (i.e., the body mass index), body composition and nutrient partitioning (i.e., % body fat), and regional fat distribution without and with standardization for total fat mass (i.e., the sum of six skinfold thicknesses, and the ratio of the sums of trunk to extremity skinfold thicknesses). Three consistent patterns of potential linkage relationships with obesity phenotypes were revealed in these data, involving the marker loci adenosine deaminase, the Kell blood group antigen, and esterase D, which identify chromosomal regions 20q13, 7q33, and 13q14, respectively. Other potential linkages also were identified in the short arm of chromosome 1, interesting because of the presence of the db and fa loci on homologous regions of chromosome 1 in mouse and rat models of obesity, respectively. Each of the tentative linkage relationships reported here warrant follow-up using alternative methods and require replication in independent studies.     

Effects of Staff Training on Nursing Home Residents’ End-Of-Life Care: A Randomized Controlled Trial

ObjectivesThis trial examines the effects of end-of-life training on long-term care facility (LTCF) residents' health-related quality of life (HRQoL) and use and costs of hospital services.DesignA single-blind, cluster randomized (at facility level) controlled trial (RCT). Our training intervention included 4 small-group 4-hour educational sessions on the principles of palliative and end-of-life care (advance care planning, adverse effects of hospitalizations, symptom management, communication, supporting proxies, challenging situations). Training was provided to all members of staff. Education was based on constructive learning methods and included resident cases, role-plays, and small-group discussions.Setting and participantsWe recruited 324 residents with possible need for end-of-life care due to advanced illness from 20 LTCF wards in Helsinki.MethodsPrimary outcome measures were HRQoL and hospital inpatient days per person-year during a 2-year follow-up. Secondary outcomes were number of emergency department visits and cost of all hospital services.ResultsHRQoL according to the 15-Dimensional Health-Related Quality-of-Life Instrument declined in both groups, and no difference was present in the changes between the groups (P for group .75, adjusted for age, sex, do-not-resuscitate orders, need for help, and clustering). Neither the number of hospital inpatient days (1.87 vs 0.81 per person-year) nor the number of emergency department visits differed significantly between intervention and control groups (P for group .41). The total hospital costs were similar in the intervention and control groups.Conclusions and ImplicationsOur rigorous RCT on end-of-life care training intervention demonstrated no effects on residents’ HRQoL or their use of hospitals. Unsupported training interventions alone might be insufficient to produce meaningful care quality improvements.     

Design and implementation of occupational health programs in the workplace: the Québec approach

This paper describes the Québec experience in the design and implementation of occupational health programs in the workplace. To begin with, a brief overview of the historical context and organisational framework of occupational health are presented. Next, each of the phases involved in the design of occupational health programs is described: identification of workers' health and safety problems, selection of action priorities, and program design, implementation and evaluation.... In the end, the roles and responsibilities of the doctors, nurses and industrial hygienists generally involved in these multidisciplinary teams are presented.     

Overcoming the Unhealthy Pursuit of Thinness: Reaction to the Québec Charter for a Healthy and Diverse Body Image

Objectives. We examined the population reach, acceptability, and perceived potential of an initiative that developed a promotional tool for a healthy body image, the Québec Charter for a Healthy and Diverse Body Image. The Charter, developed through consensus building by a multisectoral, government-led task force, outlined actions to be undertaken by organizations or citizens to reduce media pressures favoring thinness.Methods. Six months after the Charter’s launch, we surveyed 1003 Québec residents aged 18 years or older about their knowledge of the Charter, their willingness to adhere to it, and their perceptions of its potential.Results. After minimal prompting, more than 35% of respondents recognized the Charter. About 33.7% were very favorable toward personally adhering to the Charter and 32.7% perceived the Charter as having high potential to sensitize people to negative consequences of disordered eating. Women showed greater likelihood and people with lesser education showed lower likelihood of spontaneous recognition.Conclusions. An initiative involving the creation of a body image Charter reaches a substantial portion of adults and is viewed as acceptable and potentially influential.Reversing the rising tide of eating disorders is a public health priority. These include disorders characterized by the pathological pursuit of thinness (such as anorexia and bulimia nervosa) and by excessive food consumption leading to obesity.1,2 Although numerous public health actions are aimed at reducing caloric intake and stimulating healthy food choices,3,4 some authors have suggested that action on disordered eating has neglected to address the issue of unhealthy pursuit of thinness and corresponding maladaptive weight-control practices,5–8 which are common risk factors for overweight, obesity, and eating disorders. Research shows that greater exposure to images promoting excessively thin body ideals can elicit maladaptive weight-control practices and disordered eating,9–11 especially when viewers are female adolescents. Such images are markedly prevalent in Western cultures.12 Transforming body images portrayed in the media and other public venues is therefore a relevant target for population-based initiatives.13–15Throughout the world, governmental and nongovernmental organizations have implemented actions to encourage refusal to subscribe to excessively thin bodily ideals. The British Fashion Council, supported by the London Development Agency, mandated a report on the health status of fashion models that was released in 200716 and included 14 recommendations on how to promote the health of models. Similar task forces in Spain,17 Brazil,18 Italy,19 and the United States20 have developed recommendations aimed at protecting the health of fashion models, and in Argentina21 a law was adopted to establish boundaries of action for the fashion industry. Actors in France22 and Australia23 have promoted similar initiatives while adopting a broader focus on promoting healthy body images in society at large.In Québec, Canada, the Ministry of Culture, Communications, and the Status of Women spearheaded an initiative to create a health promotion tool, the Québec Charter for a Healthy and Diverse Body Image,24 which outlines consensual actions and principles that can be undertaken by organizations and citizens to reduce media pressures favoring thinness. The development of this Charter was based on a collaborative, educational (and noncoercive) inducement toward voluntary engagement on the part of actors in the fashion and media industries and in the health, social services, and education networks. (Figure 1 shows milestones and tasks completed in the development of the Charter.) The Charter incites organizations and people to pledge to

1. promote a diversity of body images, including different heights, proportions, and ages;
2. encourage healthy eating and weight-control habits;
3. discourage excessive weight-control practices or appearance modification;
4. refuse to subscribe to esthetic ideals based on extreme thinness;
5. remain vigilant and diligent so as to minimize the risks of anorexia nervosa, bulimia nervosa, and unhealthy preoccupations with weight;
6. act as agents of change so as to promote healthy eating and weight-control practices and realistic body images; and
7. promote the Québec Charter for a Healthy and Diverse Body Image among partners, clients, and others while actively respecting and adhering to its principles.

Open in a separate windowFIGURE 1—Milestones and activities in the development of the Québec Charter for a Healthy and Diverse Body Image.Note. See also the Charter’s Web site.24To our knowledge, there have been no systematic empirical efforts to date that examine the plausible outcomes of such initiatives. We therefore explored the potential contribution of the Charter to overcoming the unhealthy pursuit of thinness by collecting evidence about its population reach, acceptability, and perceived potential among Québec adults.     

Links Between Maternal Breast-Feeding Duration and Québec Infants’ Health: A Population-Based Study. Are the Effects Different for Poor Children?

OBJECTIVES: To determine whether the relationship between breastfeeding duration and the health status of 5-month-old Quebec infants differs by poverty status. METHODS: Cross-sectional study of Quebec Longitudinal Study of Child Development data of a sample of 2223 infants who were 5 months old. Two infant health indicators were considered: presence of chronic diseases and hospitalization for at least one night since birth. Differences in the associations between infant health and breastfeeding duration according to poverty status were explored using a logistic regression model and controlling for children's and mothers' characteristics. RESULTS: Infants of low-income mothers were breastfed less often and for shorter periods of time. At five months, they had poorer health compared with children from families with adequate income. However, a positive association between breastfeeding duration and these health indicators was observed and was independent of poverty level. There was no interaction between poverty level and breastfeeding duration for the two health indicators studied. CONCLUSIONS: The associations between maternal breastfeeding for 4 months or more and both hospitalizations before 5 months of age and chronic diseases are independent of family income level. However, low-income mothers breastfeed less often and for shorter periods of time. Interventions intended to promote and support breastfeeding should especially target mothers living in poverty conditions.     

Exposure of the Inuit Population of Nunavik (Arctic Québec) to Lead and Mercury

The authors conducted a survey during 1992 to evaluate blood levels of lead and mercury in Inuit adults of Nunavik (Arctic Québec, Canada). Blood samples obtained from 492 participants (209 males and 283 females; mean age = 35 yr) were analyzed for lead and total mercury; mean (geometric) concentrations were 0.42 μmol/l (range = 0.04–2.28 μmol/l) and 79.6 nmol/l (range = 4–560 nmol/l), respectively. Concentrations of omega-3 fatty acid in plasma phospholipids–a biomarker of marine food consumption–were correlated with mercury (r = .56, p < .001) and, to a lesser extent, with blood lead levels (r = .31, p < .001). Analyses of variance further revealed that smoking, age, and consumption of waterfowl were associated with lead concentrations (r ² = .30, p < .001), whereas age and consumption of seal and beluga whale were related to total mercury levels (r ² = .30, p < .001). A significant proportion of reproductive-age women had lead and mercury concentrations that exceeded those that have been reportedly associated with subtle neurodevelopmental deficits in other populations.