A two-step procedure to generate utilities for the Infant health-related Quality of life Instrument (IQI)

BACKGROUND:Because of a lack of preference-based health-related quality of life (HRQoL) instruments suitable for infants aged 0-12 months, we previously developed the Infant QoL Instrument (IQI). The present study aimed to generate an algorithm to estimate utilities for the IQI. METHODS:Via an online survey, respondents from the general population and primary caregivers from China-Hong Kong, the UK, and the USA were presented 10 discrete choice scenarios based on the IQI classification system. An additional sample of respondents from the general population were also asked if they considered the examined health states to be worse than death. Coefficients for the IQI item levels were obtained with a conditional logit model based on the responses of the primary caregivers for IQI states only. These coefficients were then normalized using the rank-ordered logit model based on the responses from the general population who assessed "death" as a choice option. In this way, the values were rescaled from full health (1.0) to death (0.0), and consequently, they became suitable for the computation of quality-adjusted life years. RESULTS:The total sample consisted of 1409 members of the general population and 1229 primary caregivers. Results indicated that, out of the 7 IQI items ("sleeping," "feeding," "breathing," "stooling/poo," "mood," "skin," and "interaction"), "breathing" had the highest impact on the HRQoL of infants. Moreover, except for "stooling," all item levels were statistically significant. The general population sample considered none of the health states as worse than death. The utility value for the worst health state was 0.015 (State 4444444). CONCLUSIONS:The IQI is the first generic instrument to assess overall HRQoL in 0-1-year-old infants by providing values and utilities. Using discrete choice experiments, we demonstrated that it is possible to derive utilities of infant health states. The next step will be to collect IQI values in a clinical population of infants and to compare these values with those of other instruments

A descriptive system for the Infant health-related Quality of life Instrument (IQI):Measuring health with a mobile app

BACKGROUND: The assessment of health-related quality of life (HRQoL) is important for health outcomes research, disease modeling studies and comparisons of different healthcare interventions. Yet, only a few tools are available to assess HRQoL in 0-1-year-old infants. Furthermore, there is a need for an instrument able to assess HRQoL with a single, standardized, overall score in the first year of life. Here we described the development of the Infant health-related Quality of life Instrument (IQI), a generic, preference-based instrument that can be administered through a mobile application for assessing HRQoL in 0-1-year-old infants. METHODS: A multi-step development process began by extracting candidate health concepts from relevant measures identified by two literature searches. Next, three panels, with experts from Asia, Europe, New Zealand and United States of America, and two surveys, with primary caregivers in New Zealand, Singapore, and the United Kingdom, evaluated the relevance of the candidate health concepts, organized them into attributes based on their similarities, explored alternative attributes and generated response scales. Additional interviews assessed the cross-cultural interpretability, parents' understanding of health attributes, and the usability of the mobile application. RESULTS: The final list of 7 health attributes included in the IQI consisted of sleeping, feeding, breathing, stooling/poo, mood, skin, and interaction. The users' experiences with the mobile application were generally positive. CONCLUSIONS: The IQI is the first generic, preference-based, instrument designed to assess overall HRQoL in 0-1-year old infants. It is short and easy-to-administer through a mobile application. Moreover, close attention was paid to the opinions of the infants' primary caregivers during the instrument and mobile application development process

Economic analysis of partially hydrolyzed guar gum (PHGG) for the treatment of patients receiving enteral nutrition

Summary: Background & Aims: Diarrhea is very common in patients receiving enteral nutrition. The principle of diarrhea treatment involves implementing dietary modifications, such as reduction of the fatty component, oral and probiotic supplementations, and increase of the fiber intake, aimed at mitigating the frequency and intensity of symptoms. In this context, partially hydrolyzed guar gum (PHGG) has emerged as a potential soluble fiber maximizing the effect against GI symptoms, particularly diarrhea. Among PHGG, NOVASOURCE® GI Control is an enteral nutrition formula indicated to improve the nutritional status and intestinal symptoms in patients with (risk of) malnutrition and intestinal barrier dysfunction, or intolerance to enteral nutrition. The objective of this economic analysis was to compare costs and effects of PHGG diet (taken with NOVASOURCE® GI Control) vs standard diet (SD, without fibers), in patients who are in need of enteral nutrition, in Italy. Methods: Two different analyses were conducted to reflect the most typical settings where enteral nutrition is relevant: i) critically-ill patients admitted to the hospital for an acute, life-threatening condition; ii) medical or (post)surgical patients. A simple decision-tree analysis was developed, with some minor differences depending on the setting. Hospital perspective was used to evaluate PHGG cost-opportunity in the hospital for critically-ill patients setting, while the Italian National Health Service (NHS) to assess the product for medical or surgical patients, assuming they were predominantly treated in an outpatient setting. Health outcomes and costs of critically-ill hospitalized patients and medical or surgical patients treated in a healthcare facility were estimated over a time horizon of 20 (PHGG group) to 27 (SD arm) days and over 24 days, respectively. Results: In the critically-ill setting, the use of PHGG diet prevented ∼12 cases of diarrhea every N=100 cases treated (relative reduction: -35%). The higher acquisition costs needed for PHGG diet (+€2,992) were more than offset by savings in all the other cost items, such as costs of hospital stay, medical therapy, costs of consumables, and cost of professional care to manage diarrhea (total saving -€1,186,330). Similarly, in medical or surgical patients, the use of PHGG was found cost-saving vs SD (-€6,040), and also reduced the number of diarrhea cases (relative reduction: -60%). Conclusions: The conducted economic analysis provides confidence that PHGG is a valuable and economically sustainable asset. Its utilization ensures not only adequate nutrition but also proves effective in mitigating diarrhea, thereby improving quality of life and limiting complication costs

The impact of food reformulation on nutrient intakes and health, a systematic review of modelling studies

Abstract Background Unhealthy diet is a risk factor for adverse health outcomes. Reformulation of processed foods has the potential to improve population diet, but evidence of its impact is limited. The purpose of this review was to explore the impact of reformulation on nutrient intakes, health outcomes and quality of life; and to evaluate the quality of modelling studies on reformulation interventions. Methods A systematic review of peer-reviewed articles published between January 2000 and December 2017 was performed using MEDLINE, ScienceDirect, Embase, Scopus, Cochrane, and the Centre for Reviews and Dissemination of the University of York. Additional studies were identified through informal searches on Google and specialized websites. Only simulation studies modelling the impact of food reformulation on nutrient intakes and health outcomes were included. Included articles were independently extracted by 2 reviewers using a standardized, pre-piloted data form, including a self-developed tool to assess study quality. Results A total of 33 studies met the selected inclusion criteria, with 20, 5 and 3 studies addressing sodium, sugar and fats reformulation respectively, and 5 studies addressing multiple nutrients. Evidence on the positive effects of reformulation on consumption and health was stronger for sodium interventions, less conclusive for sugar and fats. Study features were highly heterogeneous including differences in methods, the type of policy implemented, the extent of the reformulation, and the spectrum of targeted foods and nutrients. Nonetheless, partial between-study comparisons show a consistent relationship between percentages reformulated and reductions in individual consumption. Positive results are also shown for health outcomes and quality of life measures, although comparisons across studies are limited by the heterogeneity in model features and reporting. Study quality was often compromised by short time-horizons, disregard of uncertainty and time dependencies, and lack of model validation. Conclusions Reformulation models highlight relevant improvements in diets and population health. While models are valuable tools to evaluate reformulation interventions, comparisons are limited by non-homogeneous designs and assumptions. The use of validated models and extensive scenario analyses would improve models’ credibility, providing useful insights for policy-makers. Review Registration A research protocol was registered within the PROSPERO database (ID number CRD42017057341)

Milk Powder Fortified with Potassium and Phytosterols to Decrease the Risk of Cardiovascular Events among the Adult Population in Malaysia: A Cost-Effectiveness Analysis

This study evaluated the cost-effectiveness of the consumption of a milk powder product fortified with potassium (+1050.28 mg/day) and phytosterols (+1200 mg/day) to lower systolic blood pressure and low-density lipoprotein cholesterol, respectively, and, therefore, the risk of myocardial infarction (MI) and stroke among the 35−75-year-old population in Malaysia. A Markov model was created against a do-nothing option, from a governmental perspective, and with a time horizon of 40 years. Different data sources, encompassing clinical studies, practice guidelines, grey literature, and statistical yearbooks, were used. Sensitivity analyses were performed to evaluate the impact of uncertainty on the base case estimates. With an incremental cost-effectiveness ratio equal to international dollars (int$) 22,518.03 per quality-adjusted life-years gained, the intervention can be classified as very cost-effective. If adopted nationwide, it would help prevent at least 13,400 MIs, 30,500 strokes, and more than 10,600 and 17,100 MI- and stroke-related deaths. The discounted cost savings generated for the health care system by those who consume the fortified milk powder would amount to int$8.1 per person, corresponding to 0.7% of the total yearly health expenditure per capita. Sensitivity analyses confirmed the robustness of the results. Together with other preventive interventions, the consumption of milk powder fortified with potassium and phytosterols represents a cost-effective strategy to attenuate the rapid increase in cardiovascular burden in Malaysia

The short-term economic burden of gestational diabetes mellitus in Italy

Abstract Background The incidence of Gestational Diabetes Mellitus (GDM) is rising in all developed countries. This study aimed at assessing the short-term economic burden of GDM from the Italian healthcare system perspective. Methods A model was built over the last pregnancy trimester (i.e., from the 28th gestational week until childbirth included). The National Hospital Discharge Database (2014) was accessed to estimate delivery outcome probabilities and inpatient costs in GDM and normal pregnancies (i.e., euglycemia). International Classification of Disease-9th Revision-Clinical Modification (ICD9-CM) diagnostic codes and Diagnosis-Related Group (DRG) codes were used to identify GDM cases and different types of delivery (i.e., vaginal or cesarean) within the database. Neonatal outcomes probabilities were estimated from the literature and included macrosomia, hypoglycemia, hyperbilirubinemia, shoulder dystocia, respiratory distress, and brachial plexus injury. Additional data sources such as regional documents, official price and tariff lists, national statistics and expert opinion were used to populate the model. The average cost per case was calculated at national level to estimate the annual economic burden of GDM. One-way sensitivity analyses and Monte Carlo simulations were performed to quantify the uncertainty around base case results. Results The amount of pregnancies complicated by GDM in Italy was assessed at 54,783 in 2014 using a prevalence rate of 10.9%. The antenatal outpatient cost per case was estimated at €43.7 in normal pregnancies compared to €370.6 in GDM patients, which is equivalent to a weighted sum of insulin- (14%; €1034.6) and diet- (86%; €262.5) treated women’s costs. Inpatient delivery costs were assessed at €1601.6 and €1150.3 for euglycemic women and their infants, and at €1835.0 and €1407.7 for GDM women and their infants, respectively. Thus, the overall cost per case difference between GDM and normal pregnancies was equal to €817.8 (+ 29.2%), resulting in an economic burden of about €44.8 million in 2014 at national level. Probabilistic sensitivity analysis yielded a cost per case difference ranging between €464.9 and €1164.8 in 80% of simulations. Conclusions The economic burden of GDM in Italy is substantial even accounting for short-term medical costs only. Future research also addressing long-term consequences from a broader societal perspective is recommended

Valuing Health Status in the First Year of Life: The Infant Health-Related Quality of Life Instrument

OBJECTIVES: Efforts to evaluate HRQoL and calculate quality-adjusted life years (QALYs) for infants less than 12 months of age are hampered by the lack of preference-based HRQoL instruments for this group. To fill this gap, we developed the Infant Quality of life Instrument (IQI), which is administered through a mobile application. This article explains how weights were derived for the 4 levels of each health item. METHODS: The IQI includes 7 health items: sleeping, feeding, breathing, stooling/poo, mood, skin, and interaction. In an online survey, respondents from the general population (n = 1409) and primary caregivers (n = 1229) from China, the United Kingdom, and the United States were presented with 10 discrete choice scenarios. Coefficients for the item levels were obtained with a conditional logit model. RESULTS: The highest coefficients were found for sleeping, feeding, and breathing. All coefficients for these items were negative and logically ordered, meaning that more extreme levels were less preferred. Stooling, mood, skin, and interaction showed some irregularities in the ordering of coefficients. Results for caregivers and the general population were about the same. CONCLUSIONS: The IQI is the first generic instrument to assess overall HRQoL in infants up to 1 year of age. It is short and easy to administer through a mobile application. We demonstrated how to derive values for infant health states with a discrete choice methodology. Our next step will be to normalize these values into utilities ranging from 0 (dead) to 1 (best health state) and to collect IQI values in a clinical population