Incidence trend of type 2 diabetes from 2012 to 2021 in Germany: an analysis of health claims data of 11 million statutorily insured people.

AIMS/HYPOTHESIS: The aim of the study is to describe the time trend of type 2 diabetes incidence in the largest state of Germany, Bavaria, from 2012 to 2021, and to compare the incidence rates during the pandemic period (2020-2021) to the pre-pandemic period (2012-2019). METHODS: This secondary data analysis uses health claims data provided by the Bavarian Association of Statutory Health Insurance Physicians (KVB), covering approximately 11 million insurees, accounting for 85% of the total population of Bavaria, Germany. Newly diagnosed type 2 diabetes cases in adults (≥20 years) coded as E11 (Diabetes mellitus, Type 2) or E14 (Unspecified diabetes mellitus) under ICD-10, German modification (ICD-10-GM) for the study period 2012 to 2021 were included. Annual and quarterly age-standardised incidence rates (ASIR) stratified by sex, age and region were calculated using the European standard population. Sex-specific crude incidence rates (CIR) were calculated using 10-year age groups. Regression analyses adjusted for time trends, seasonal effects, and pandemic effects were used to analyse the incidence trend and to assess the effect of the pandemic. RESULTS: Overall, 745,861 new cases of type 2 diabetes were diagnosed between 2012 and 2021: 50.4% (376,193 cases) in women. The male/female ratio remained stable over the observation period, while the median age at diagnosis decreased from 61 to 58 years in men and from 66 years to 61 years in women. ASIR were consistently higher for men compared with women, with the yearly difference remaining stable over time (2012: 18%; 2021: 20%). An overall decreasing trend in ASIR was observed during the study period, with a strong decrease from 2012 to 2017, followed by a less pronounced decline from 2018 to 2021 for both sexes. For men, ASIR decreased from 1514 per 100,000 person-years in 2012 to 995 per 100,000 person-years in 2021 (4.6% average annual reduction), and for women from 1238 per 100,000 person-years in 2012 to 796 per 100,000 person-years in 2021 (4.8% average annual reduction). This downward trend was also observed for age groups above 50 years. Regression analyses showed no significant change in incidence rates during the pandemic period (2020 and 2021) compared with the pre-pandemic period. CONCLUSIONS/INTERPRETATION: For the first time, a 10-year incidence trend of type 2 diabetes is reported for Germany, showing a strong decline from 2012 to 2017, followed by a less pronounced decline from 2018 to 2021. The incidence trend of type 2 diabetes appears not to have been affected by the first 2 years of the COVID-19 pandemic. Despite an overall increasing prevalence, the incidence is decreasing, potentially resulting from robust screening by family physicians, reducing the median age at diagnosis by 3 to 5 years. However, further investigation is needed to fully identify the reasons for the declining incidence trend. Continued incidence monitoring is necessary to identify the long-term trend and the potential effect of the pandemic on diagnoses of type 2 diabetes.

Sick leave before, during, and after short-term outpatient psychotherapy: a cohort study on sick leave days and health care costs between behavioral and psychodynamic psychotherapies on anonymized claims data.

BACKGROUND: Sick leave due to mental disorders poses a relevant societal and economic burden. Research on sick leave over a patient journey of individuals who received one of two treatment approaches - either behavioral (BT) or psychodynamic (PDT) psychotherapy - is scarce. METHODS: We conducted a cohort study on anonymized German claims data for propensity-score matched patients who received short-term outpatient BT or PDT. We analyzed sick leave days and direct health care costs one year before, during, and one year after psychotherapy. RESULTS: We analyzed data of patients who received BT and PDT, with N = 14 530 patients per group after matching. Patients showed sick leave days per person year of 33.66 and 35.05 days before, 35.99 and 39.74 days during, and 20.03 and 20.95 days after BT and PDT, respectively. Sick leave rates were overall higher in patients who received PDT. Both patient groups showed reductions of roughly 14 sick leave days per year, or 40%, from before to after therapy without a difference between BT and PDT (difference-in-difference [DiD] = -0.48, 95%-confidence interval [CI] -1.61 to 0.68). Same applies to direct health care costs which reduced in both groups by roughly 1800 EUR (DiD = 0, 95%-CI -158 to 157). CONCLUSIONS: Results suggest similar reductions in sick leave days and direct health care costs from before to after BT and PDT. As sick leave is discussed to serve as an indicator of overall health and functioning in mental disorders, both treatments may have a similar positive impact on mental health.

Montelukast as a repurposable additive drug for standard-efficacy multiple sclerosis treatment: Emulating clinical trials with retrospective administrative health claims data.

BACKGROUND: Effective and safe treatment options for multiple sclerosis (MS) are still needed. Montelukast, a leukotriene receptor antagonist (LTRA) currently indicated for asthma or allergic rhinitis, may provide an additional therapeutic approach. OBJECTIVE: The study aimed to evaluate the effects of montelukast on the relapses of people with MS (pwMS). METHODS: In this retrospective case-control study, two independent longitudinal claims datasets were used to emulate randomized clinical trials (RCTs). We identified pwMS aged 18-65 years, on MS disease-modifying therapies concomitantly, in de-identified claims from Optum's Clinformatics® Data Mart (CDM) and IQVIA PharMetrics® Plus for Academics. Cases included 483 pwMS on montelukast and with medication adherence in CDM and 208 in PharMetrics Plus for Academics. We randomly sampled controls from 35,330 pwMS without montelukast prescriptions in CDM and 10,128 in PharMetrics Plus for Academics. Relapses were measured over a 2-year period through inpatient hospitalization and corticosteroid claims. A doubly robust causal inference model estimated the effects of montelukast, adjusting for confounders and censored patients. RESULTS: pwMS treated with montelukast demonstrated a statistically significant 23.6% reduction in relapses compared to non-users in 67.3% of emulated RCTs. CONCLUSION: Real-world evidence suggested that montelukast reduces MS relapses, warranting future clinical trials and further research on LTRAs' potential mechanism in MS.

Impact of product packaging messages on consumer perceptions and choice: The role of health claims and bonus pack promotions.

This study used mixed methods to explore the impact of front-of-package health claims and bonus pack messages on consumer evaluations. First, a comprehensive audit of cereal box packages at the world's largest retailer examined how these messages are presented in practice. It was found that negative claims are more frequent and positive claims are less frequent on products with a bonus pack message compared to those without. A subsequent experiment investigated how combinations of health claims and bonus pack messages influence consumer evaluations. It also found that health claims significantly influenced consumer preferences, while bonus pack messages diminished perceptions of food healthiness but increased perceived value. Pairing positive health claims with bonus pack messages, such as "Family Size," improved perceptions of healthiness. Moreover, positive health claims made products seem of lower value, whereas negative health claims did not affect perceived value. Health claims negatively affected value perceptions, even when paired with bonus pack messages like "Large Size." However, the negative effect of health claims on tastiness perceptions was mitigated with "Large Size". The study underscores the complexity of consumer decision-making, and offer insights for food marketers, emphasizing the need of a strategic approach in crafting health-related messaging and promotional strategies for product packaging.

Sex differences in cardiologic medication provision for adults with coronary heart disease: an analysis of health claims data from 2018 to 2020 in Saxony-Anhalt, Germany.

BACKGROUND: Coronary heart diseases (CHDs) have experienced the largest increase worldwide as a cause of death, accounting for 16% of all deaths. In Saxony-Anhalt, a federal state in Germany, both CHD morbidity and acute myocardial infarction mortality rates are particularly high. Several risk factors associated with CHDs have been studied in Saxony-Anhalt, but sex differences in service use and medication have not been investigated. This study therefore aimed to investigate sex differences in the quality and quantity of cardiological care provided to adults with CHD. METHODS: This study used health claims data from 2018 to 2020 to analyse the utilisation of healthcare services and adherence to medication-related guideline recommendations in primary and specialist care. The sample included 133,661 individuals with CHD from a major statutory health insurance company (Germany). RESULTS: Almost all CHD patients (> 99%) received continuous primary care. Continuous cardiologist utilisation was lower for females than for males, with 15.0% and 22.2%, respectively, and sporadic utilisation showed greater differences, with 33.5% of females and 43.4% of males seeking sporadic cardiologist consultations. Additionally, 43.1% of the identified CHD patients participated in disease management programmes (DMPs). The study also examined the impact of DMP participation and cardiologist care on medication uptake and revealed that sex differences in medication uptake, except for statin use, were mitigated by these factors. Statins were prescribed to 42.9% of the CHD patients eligible for statin prescription in accordance with the QiSA indicator for statin prescription eligibility. However, there were significant sex differences in statin utilisation. Female CHD patients were less likely to use statins (35.2%) than male CHD patients were (50.1%). The difference in statin utilisation persisted after adjustment for DMP participation and cardiologist consultation. CONCLUSIONS: This study highlights sex differences in the utilisation of cardiological healthcare services for patients with CHD in the Saxony-Anhalt cohort. These findings underscore the continuing need for interventions to reduce sex inequalities in accessing healthcare and providing health care for patients with CHD. Factors at the health care system, patient, and physician levels should be further investigated to eventually improve statin prescription in people with CHD, especially women.

The nutraceutical properties and health benefits of pseudocereals: a comprehensive treatise.

This review article depicts the possible replacement of staple cereal sources with some pseudocereals like Chia, Quinoa, Buckwheat, and Amaranth, which not only provide recommended daily allowance of all nutrients but also help to reduce the chances of many non-communicable infections owing to the presence of several bioactive compounds. These pseudocereals are neglected plant seeds and should be added in our routine diet. Besides, they can serve as nutraceuticals in combating various diseases by improving the health status of the consumers. The bioactive compounds like rutin, quercetin, peptide chains, angiotensin I, and many other antioxidants present in these plant seeds help to reduce the oxidative stress in the body which leads toward better health of the consumers. All these pseudocereals have high quantity of soluble fiber which helps to regulate bowel movement, control hypercholesterolemia (presence of high plasma cholesterol levels), hypertension (high blood pressure), and cardiovascular diseases. The ultimate result of consumption of pseudocereals either as a whole or in combination with true cereals as staple food may help to retain the integrity of the human body which increases the life expectancy by slowing down the aging process.

Nature of the evidence base and strengths, challenges and recommendations in the area of nutrition and health claims: a position paper from the Academy of Nutrition Sciences.

The regulation of health claims for foods by the Nutrition and Health Claims Regulation is intended, primarily, to protect consumers from unscrupulous claims by ensuring claims are accurate and substantiated with high quality scientific evidence. In this position paper, the Academy of Nutrition Sciences uniquely recognises the strengths of the transparent, rigorous scientific assessment by independent scientists of the evidence underpinning claims in Europe, an approach now independently adopted in UK. Further strengths are the separation of risk assessment from risk management, and the extensive guidance for those submitting claims. Nevertheless, four main challenges in assessing the scientific evidence and context remain: (i) defining a healthy population, (ii) undertaking efficacy trials for foods, (iii) developing clearly defined biomarkers for some trial outcomes and (iv) ensuring the composition of a food bearing a health claim is consistent with generally accepted nutrition principles. Although the Regulation aims to protect the consumer from harm, we identify some challenges from consumer research: (i) making the wording of some health claims more easily understood and (ii) understanding the implications of the misperceptions around products bearing nutrition or health claims. Recommendations are made to overcome these challenges. Further, the Academy recommends that a dialogue is developed with the relevant national bodies about Article 12(c) in the Regulation. This should further clarify the GB Guidance to avoid the current non-level playing field between health professionals and untrained 'influencers' who are not covered by this Article about the communication of authorised claims within commercial communications.

Health-related cues on the packages of processed and ultra-processed products: prevalence and policy implications.

The information included on food packages has a crucial role in influencing consumer product associations and purchase decisions. In particular, visual and textual cues on processed and ultra-processed products can convey health-related associations that influence consumer healthiness perception and purchase decisions. In this context, the present work aimed to explore the use of health-related cues on the packages of processed and ultra-processed products sold in Uruguay to provide insights for policy making. A total of 3813 products from thirty-four different food categories found in four of the most important supermarket chains in Uruguay were surveyed. The textual and visual information included on the packages as well as the nutritional composition of the products were analysed. Results showed that 67 % of the products included at least one health-related cue. Pictures of culinary ingredients, natural and minimally processed foods were the most frequent health-related cue, followed by references to naturalness and claims related to critical nutrients. The prevalence of health-related cues largely differed across product categories, ranging from 100 to 17 %. The relationship between the presence of health-related cues on the packages and the excessive content of nutrients associated with non-communicable diseases was assessed using a gradient boosting model, which showed limited predictive ability. This suggests that the inclusion of health-related cues on food packages was not strongly related to the nutritional composition of products and therefore cannot be regarded as a healthiness indicator. These results stress the need to develop stricter labelling regulations to protect consumers from misleading information.

Survival of patients undergoing cardiac resynchronization therapy with or without defibrillator: the RESET-CRT project.

AIMS: Cardiac resynchronization therapy (CRT) is an established treatment for heart failure. There is contradictory evidence whether defibrillator capability improves prognosis in patients receiving CRT. We compared the survival of patients undergoing de novo implantation of a CRT with defibrillator (CRT-D) option and CRT with pacemaker (CRT-P) in a large health claims database. METHODS AND RESULTS: Using health claims data of a major German statutory health insurance, we analysed patients with de novo CRT implantation from 2014 to 2019 without indication for defibrillator implantation for secondary prevention of sudden cardiac death. We performed age-adjusted Cox proportional hazard regression and entropy balancing to calculate weights to control for baseline imbalances. The analysis comprised 847 CRT-P and 2722 CRT-D patients. Overall, 714 deaths were recorded during a median follow-up of 2.35 years. A higher cumulative incidence of all-cause death was observed in the initial unadjusted Kaplan-Meier time-to-event analysis [hazard ratio (HR): 1.63, 95% confidence interval (CI): 1.38-1.92]. After adjustment for age, HR was 1.13 (95% CI: 0.95-1.35) and after entropy balancing 0.99 (95% CI: 0.81-1.20). No survival differences were found in different age groups. The results were robust in sensitivity analyses. CONCLUSION: In a large health claims database of CRT implantations performed in a contemporary setting, CRT-P treatment was not associated with inferior survival compared with CRT-D. Age differences accounted for the greatest part of the survival difference that was observed in the initial unadjusted analysis.

Dementia risk predictions from German claims data using methods of machine learning.

INTRODUCTION: We examined whether German claims data are suitable for dementia risk prediction, how machine learning (ML) compares to classical regression, and what the important predictors for dementia risk are. METHODS: We analyzed data from the largest German health insurance company, including 117,895 dementia-free people age 65+. Follow-up was 10 years. Predictors were: 23 age-related diseases, 212 medical prescriptions, 87 surgery codes, as well as age and sex. Statistical methods included logistic regression (LR), gradient boosting (GBM), and random forests (RFs). RESULTS: Discriminatory power was moderate for LR (C-statistic = 0.714; 95% confidence interval [CI] = 0.708-0.720) and GBM (C-statistic = 0.707; 95% CI  = 0.700-0.713) and lower for RF (C-statistic = 0.636; 95% CI  = 0.628-0.643). GBM had the best model calibration. We identified antipsychotic medications and cerebrovascular disease but also a less-established specific antibacterial medical prescription as important predictors. DISCUSSION: Our models from German claims data have acceptable accuracy and may provide cost-effective decision support for early dementia screening.

Psyllium: a useful functional ingredient in food systems.

Psyllium gum is a hydrocolloid found in the husk of seeds from Plantago ovata. Psyllium husk has been used in traditional medicine in areas of India and China. Its consumption has been shown to provide nutritional benefits, such as the capacity to reduce the glycaemic index, to minimize the risk of cardiovascular diseases, to decrease cholesterol and constipation problems and others. Thus, interest in the incorporation of psyllium in food products is twofold. First, it can be a natural alternative to the use of other gums and hydrocolloids considered additives. Second, it can be used to improve the nutritional properties of products in which it is incorporated. However, for this purpose, it is necessary to add great quantities of psyllium. This review analyses the potential use of psyllium in distinct food products, considering its advantages and inconveniences as well as possible solutions for undesired effects. Among the analyzed products there are bakery products and, in particular, gluten-free breads where psyllium has been used as a gluten substitute. The incorporation of psyllium into dairy products such as yogurts and those derived from fruits, among others, is also addressed.

A long-term cost-effectiveness analysis of cardiac resynchronisation therapy with or without defibrillator based on health claims data.

BACKGROUND: In Germany, CRT devices with defibrillator capability (CRT-D) have become the predominant treatment strategy for patients with heart failure and cardiac dyssynchrony. However, according to current guidelines, most patients would also be eligible for the less expensive CRT pacemaker (CRT-P). We conducted a cost-effectiveness analysis for CRT-P devices compared to CRT-D devices from a German payer's perspective. METHODS: Longitudinal health claims data from 3569 patients with de novo CRT implantation from 2014 to 2019 were used to parametrise a cohort Markov model. Model outcomes were costs and effectiveness measured in terms of life years. Transition probabilities were derived from multivariable parametric survival regression that controlled for baseline differences of CRT-D and CRT-P patients. Deterministic and probabilistic sensitivity analyses were conducted. RESULTS: The Markov model predicted a median survival of 84 months for CRT-P patients and 92 months for CRT-D patients. In the base case, CRT-P devices incurred incremental costs of € - 13,093 per patient and 0.30 incremental life years were lost. The ICER was € 43,965 saved per life year lost. In the probabilistic sensitivity analysis, uncertainty regarding the effectiveness was observed but not regarding costs. CONCLUSION: This modelling study illustrates the uncertainty of the higher effectiveness of CRT-D devices compared to CRT-P devices. Given the difference in incremental costs between CRT-P and CRT-D treatment, there would be significant potential cost savings to the healthcare system if CRT-D devices were restricted to patients likely to benefit from the additional defibrillator.

Stability of individual dementia diagnoses in routine care: Implications for epidemiological studies.

PURPOSE: Epidemiological and health care research frequently rely on diagnoses from routine care, but the intra-individual stability of diagnoses of Alzheimer's disease (AD), vascular dementia (VD) or other forms of dementia (oD) in patients over time is understudied. More data on the diagnostic stability is needed to appraise epidemiological findings from such studies. METHODS: Using health claims data of the years 2004-2016 from the German Pharmacoepidemiological Research Database, 160 273 patients aged ≥50 with incident dementia were identified and followed for 4 years. According to the incident ICD-10 codes patients were assigned to the categories AD, VD or oD. Changes between categories during follow-up were calculated. RESULTS: Overall, 18.8% had incident AD (VD: 21.5%, oD: 59.7%). Fifteen thousand eight hundred forty-two patients had only one dementia diagnosis during 4 years (AD: 7.4%, VD: 12.4%, oD: 9.8%). Among those with more than one diagnosis, the incident diagnosis matched the last diagnosis in 65.1% (AD), 53.9% (VD) and 73.8% (oD) of patients. Changes in the diagnostic category were higher in patients with AD (mean: 5.1) than in patients with VD (3.6) or oD (3.3). Patients with stable AD diagnoses during the observation period were younger (median: 76 vs. 79 years) and had less inpatient treatment days (median: 14 days) than patients with changes from an AD diagnosis to another category or from another category to AD (27 days). CONCLUSIONS: While health claims data are feasible for estimating the incidence of dementia in general, the substantial number of changes in dementia diagnoses during the course of the disease warrant caution on the interpretation of epidemiological data on specific dementia types.

Diabetes duration and the risk of dementia: a cohort study based on German health claims data.

OBJECTIVE: Diabetes is a risk factor for dementia but little is known about the impact of diabetes duration on the risk of dementia. We investigated the effect of type 2 diabetes duration on the risk of dementia. DESIGN: Prospective cohort study using health claims data representative for the older German population. The data contain information about diagnoses and medical prescriptions from the in- and outpatient sector. METHODS: We performed piecewise exponential models with a linear and a quadratic term for time since first type 2 diabetes diagnosis to predict the dementia risk in a sample of 13,761 subjects (2,558 dementia cases) older than 65 years. We controlled for severity of diabetes using the Adopted Diabetes Complications Severity Index. RESULTS: We found a U-shaped dementia risk over time. After type 2 diabetes diagnosis the dementia risk decreased (26% after 1 year) and reached a minimum at 4.75 years, followed by an increase through the end of follow-up. The pattern was consistent over different treatment groups, with the strongest U-shape for insulin treatment and for those with diabetes complications at the time of diabetes diagnosis. CONCLUSIONS: We identified a non-linear association of type 2 diabetes duration and the risk of dementia. Physicians should closely monitor cognitive function in diabetic patients beyond the first few years after diagnosis, because the later increase in dementia occurred in all treatment groups.

The influence of primary care quality on nursing home admissions in a multimorbid population with and without dementia in Germany: a retrospective cohort study using health insurance claims data.

BACKGROUND: Multimorbidity poses a challenge for high quality primary care provision for nursing care-dependent people with (PWD) and without (PWOD) dementia. Evidence on the association of primary care quality of multimorbid PWD and PWOD with the event of a nursing home admission (NHA) is missing. This study aimed to investigate the contribution of individual quality of primary care for chronic diseases in multimorbid care-dependent PWD and PWOD on the duration of ongoing residence at home before the occurrence of NHA. METHODS: We conducted a retrospective cohort study among elderly care-dependent PWD and PWOD in Germany for six combinations of chronic diseases using statutory health insurance claims data (2007-2016). Primary care quality was measured by 21 process and outcome indicators for hypertension, diabetes, depression, chronic obstructive pulmonary disease and heart failure. The primary outcome was time to NHA after initial onset of care-dependency. Multivariable Cox proportional hazard models were used to compare the time-to-event between PWD and PWOD. RESULTS: Among 5876 PWD and 12,837 PWOD 5130 NHA occurred. With the highest proportion of NHA for PWD with hypertension and depression and for PWOD with hypertension, diabetes and depression. Average duration until NHA ranged from 6.5 to 8.9 quarters for PWD and from 9.6 to 13.5 quarters for PWOD. Adjusted analyses show consistent associations of the quality of diabetes care with the duration of remaining in one's own home regardless of the presence of dementia. Process indicators assessing guideline-fidelity are associated with remaining in one's home longer, while indicators assessing complications, such as emergency inpatient treatment (HR = 2.67, 95% CI 1.99-3.60 PWD; HR = 2.81, 95% CI 2.28-3.47 PWOD) or lower-limb amputation (HR = 3.10, 95% CI 1.78-5.55 PWD; HR = 2.81, 95% CI 1.94-4.08 PWOD) in PWD and PWOD with hypertension and diabetes, increase the risk of NHA. CONCLUSIONS: The quality of primary care provided to care-dependent multimorbid PWD and POWD, influences the time individuals spend living in their own homes after onset of care-dependency before a NHA. Health care professionals should consider possibilities and barriers of guideline-based, coordinated care for multimorbid care-dependent people. Further research on quality indicator sets that acknowledge the complexity of care for multimorbid elderly populations is needed.

Medication adherence and persistence among patients with non-small cell lung cancer receiving tyrosine kinase inhibitors and estimation of the economic burden associated with the unused medicines.

BACKGROUND: Non-small cell lung cancer (NSCLC) is a leading cause of cancer deaths. Its treatment includes specific oral tyrosine kinases inhibitors (TKIs). OBJECTIVES: To estimate adherence and persistence among patients receiving TKIs and to assess the economic burden of the unused medicines in Alsace (France). METHOD: This retrospective study was carried out using the Insurance Healthcare database. MAIN OUTCOME MEASURES: Adherence was calculated using medication possession ratio (MPR), persistence using estimated level of persistence with therapy (ELPT) and economic impact using prescription refill data. RESULTS: 242 patients were receiving TKIs. The most common TKIs prescribed were erlotinib (75.6%, n = 183) and crizotinib (12.8%, n = 31). Total of 149 patients were included in the adherence analysis. Overall MPR was 0.98. 180 patients were included in the persistence analysis. Almost half of patients had stopped treatment at 60 days and only 38.3% (n = 69) were still persistent with the therapy at 120 days. The expenses related to unused TKIs amounted to €356,392 and were related majorly to treatment discontinuation followed by overlapping refills, patient deaths and dose- or drug-switching, respectively. CONCLUSIONS: Our data indicated overall adherence medicines above the acceptable limit of 0.80 but also pointed out a significant decline in persistence over time. The resulting economic losses justify the need for physicians and pharmacists to closely monitor their patients to ensure continuity of treatment. To limit the cost associated with unused medicines, interventions such as app-based monitoring, dispensing TKIs per unit over shorter periods and not only on monthly intervals could be implemented.

The effects of nutrition and health claims on the nutrient composition of single and subsequent meal servings.

Nutrition and health claims (NHCs) can help individuals make better food choices. While NHCs have been found to influence consumer perceptions and consumption, there has been less focus on how claims influence the nutritional composition of servings. There has also been little attention paid to longer term or compensatory effects of claims on subsequent food selection. This manuscript details two studies considering these matters. Study 1 (n = 60) was a within-subjects experiment to measure the impact of NHCs on food selection and nutritional composition at single meal servings. Participants served from three fake food buffet meal stations (breakfast, hot meal, snacks) with NHCs present or absent. Study 2 (n = 55) was a within-subjects experiment to examine the impact of NHCs on food selection and nutritional composition at a subsequent meal. Participants served from a fake food buffet breakfast with or without NHCs followed by a lunch without NHCs. In study 1, while results varied for different meals, the presence of claims was found to significantly reduce the amount of energy, fat, saturated fat, sugar, carbohydrates, and sodium, and increase the amount of protein in meals that were served. Results for fibre were mixed. In addition, NHCs increased the quantity of food served in the snacks condition. There was no evidence of claims at breakfast impacting the nutritional composition of subsequent lunch servings in study 2. Despite claims potentially increasing serving quantities, the nutritional composition of chosen servings was more encouraging and claims may help individuals to meet recommended nutritional daily guidelines. These findings have wider implications in terms of government policy, food reformulation, and the continuing debate around the use of nutrient profiling regulations for products carrying claims.

Front-of-pack health imagery on both 'healthy' and 'unhealthy' foods leads people to misremember seeing health claims: Two memory experiments.

Front-of-pack health imagery can shape people's inferences about food products' health benefits, even leading people to falsely remember reading health claims they never saw. However, research has typically examined these effects in situations where participants have little contextual information to guide their inferences about a product. The present research aimed to replicate the finding that front-of-pack health imagery leads participants to falsely remember reading health claims. It also extends that finding, by exploring whether this effect is moderated by the presence of contextual information signaling the product's actual 'healthiness'. In two pre-registered experiments, participants saw images of fictitious food products accompanied by written nutrition claims. Some of the products contained a health-related image whereas others did not. The supposed 'healthiness' of each product was manipulated by altering the color of the products' multiple traffic light (MTL) label (Experiment 1), or with an explicit healthiness statement (Experiment 2). Participants then attempted to remember the written claims that had appeared on each product's packaging. Health-related images increased participants' tendency to falsely remember reading health claims. But this was true regardless of whether or not participants saw contextual cues about the products' healthiness, either indirectly (Experiment 1) or directly (Experiment 2). These findings suggest that the presence of health imagery on a food product's package can lead consumers to infer health benefits, even when other, more direct cues indicate that the product is unhealthy. This research informs debates on safeguarding consumers from potentially misleading health claims, through the regulation of imagery in food marketing.

Front-of-package claims & imagery on fruit-flavored drinks and exposure by household demographics.

Young children regularly consume sugary fruit drinks, in part because parents may falsely believe they are healthful due to front-of-package (FOP) claims and imagery. The goal of this study was to assess: 1) the prevalence of FOP claims/imagery on fruit-flavored beverages purchased by U.S. households with 0-5-year-olds, and 2) proportional differences in beverages purchased with FOP claims/imagery across household demographic groups. A content analysis of FOP claims/imagery (e.g., nutrient claims, fruit imagery) on beverages (n = 1365) purchased by households with 0-5-year-olds was conducted by linking beverage sales with FOP marketing data. Results were merged with purchasing data from a nationally representative sample of households (FoodAPS), and survey-weighted logistic regression was used to assess differences in the proportions of 100% juices and fruit drinks with specific FOP claims/imagery purchased by household race/ethnicity, income, and SNAP/WIC participation. The most common claims on fruit-flavored beverages included nutrient claims (fruit drinks: 73%; 100% juices: 68%; flavored waters: 95%), which most commonly highlighted vitamin C (35-41% across beverage categories) and the absence of sugar (31-48%). Most beverages also contained implied-natural claims (fruit drinks: 60%; 100% juices: 64%; flavored waters: 95%) and natural imagery (fruit drinks: 97%; 100% juices: 96%; flavored waters: 73%). A large proportion of fruit drinks and 100% juices purchased by households across all demographic groups contained FOP claims and imagery, with a few minor differences between racial/ethnic groups. In conclusion, most fruit drinks, 100% juices, and flavored waters purchased by households with 0-5-year-olds contained FOP claims and imagery that may lead consumers to believe the beverages are healthy and natural. FDA regulations should ensure parents are not misled by this marketing.

"The Perfect Formula:" Evaluating Health Claims, Products and Pricing on Cannabis Dispensary Websites in Two Recently Legalized States.

Introduction: Many cannabis dispensaries market and sell their products online through websites designed to attract and maintain customers; often, these websites incorporate a variety of product claims and other marketing tactics. This study evaluated website content, product pricing and discounts on dispensary websites in California and Nevada, states that legalized recreational cannabis in 2016. Methods: We content coded product availability, marketing claims and discounts on cannabis dispensary websites in the San Francisco Bay Area (N = 34) and Reno (N = 15) from March to June 2020 using a web crawler to scrape pricing information for four product types. We conducted bivariate analyses comparing both locations. Results: Prices were significantly lower for flower, edibles, and concentrates in Reno compared to the Bay Area, but not cartridges. In both areas, a range of marketing claims were made regarding the health effects of certain products. The most common were that cannabis products treated pain, nausea/vomiting, spasms, anxiety, insomnia, and depression. Products were also said to promote creativity and euphoria. Other marketing claims related to potency, pleasure enhancement, and improved social interactions. Discounts targeted to senior citizens and veterans were found on over half of all websites. Conclusions: Dispensary websites in the Bay Area and Reno frequently make health-related claims which should not be allowed in absence of scientific evidence. Non-health related claims are similar to those used for selling e-cigarettes and other tobacco products. Monitoring cannabis dispensary websites provides insight into local sales tactics and may help identify subpopulations for research on behavioral impacts of cannabis marketing activities.