Beliefs and Motivations Regarding Early Shared Reading of Parents From Low-Income Households: A Qualitative Study.

OBJECTIVE: Parent-child "shared" reading is a catalyst for development of language and other emergent literacy skills. The American Academy of Pediatrics recommends that parents initiate shared reading as soon as possible after birth. Persistent disparities exist in reading resources, routines, and subsequent literacy outcomes, disproportionately impacting low-income households. We sought to understand beliefs, motivations, and experiences regarding shared reading during early infancy among parents from low-income households. METHODS: In this qualitative exploratory study, parents of infants aged 0 to 9 months from low-income households who had initiated shared reading ("readers") and those who had not ("nonreaders") were purposefully recruited to participate in individual semistructured virtual interviews. These interviews were coded using inductive thematic analysis by a 3-member team with diverse backgrounds. RESULTS: A total of 21 parents participated (57% readers, 86% mothers). Infants were 86% African American/Black, with a mean age of 3 months. Barriers noted by readers and nonreaders were i) competing demands on time, ii) lack of resources, and iii) parental mental health. An additional barrier noted solely by nonreaders was iv) it's too early/baby is not ready. Two benefits of reading were noted by both groups: 1) parents as child's first teachers and 2) reading catalyzes the child's development. Benefits noted exclusively by readers included 3) reading begets more reading, 4) bonding, 5) "it works," and 6) "two-for-one" shared reading (other children involved). CONCLUSIONS: This study provided insights into barriers and benefits regarding shared reading by socioeconomically disadvantaged parents of infants and has the potential to inform reading-related guidance and interventions.

Exploratory Mixed-Methods Study of a Primary Care-Based Intervention Promoting Shared Reading During Infancy.

Parent-child "shared" reading can be a rich source of language exposure. Clinic-based programs, notably Reach Out and Read (ROR), are intended to enhance this. However, ROR has been traditionally introduced at 6 months and only recently expanded to younger ages. This study explored efficacy of an intervention delivered during pediatric well visits promoting shared reading prior to 6 months old, in terms of home reading attitudes and routines. The intervention group received children's books and anticipatory guidance about benefits of shared reading, whereas the control group received general age-related anticipatory guidance. Surveys were administered at the child's newborn (pre-intervention) and 6-month (post-intervention) well visits. Significant findings at 6 months included more frequent shared reading (P = .03), greater comfort reading at this age (P = .01), and greater importance attributed to shared reading (P = .04) in the intervention group relative to controls. These support the expansion of early literacy interventions such as ROR into early infancy.

Validation of The Reading House and Association With Cortical Thickness.

BACKGROUND AND OBJECTIVES: The American Academy of Pediatrics recommends literacy and school readiness promotion during well visits. The Reading House (TRH) is a children's book-based screener of emergent literacy skills in preschool-aged children. Vocabulary, rhyming, and rapid naming are core emergent skills, and reading abilities are associated with thicker cortex in the left hemisphere. Our objective was to expand validity of TRH relative to these skills and explore association with cortical thickness. METHODS: Healthy preschool-aged children completed MRI including a T1-weighted anatomic scan. Before MRI, TRH and assessments of rapid naming (Comprehensive Test of Phonological Processing, Second Edition), rhyming (Pre-Reading Inventory of Phonological Awareness), vocabulary (Expressive Vocabulary Test, Second Edition), and emergent literacy (Get Ready to Read!) were administered. Analyses included Spearman-ρ correlations (r ρ) accounting for age, sex, and socioeconomic status (SES). MRI analyses involved whole-brain measures of cortical thickness relative to TRH scores, accounting for covariates. RESULTS: Seventy children completed assessments (36-63 months old; 36 female) and 52 completed MRI (37-63 months; 29 female). TRH scores were positively correlated with Comprehensive Test of Phonological Processing, Second Edition (r ρ = 0.61), Expressive Vocabulary Test, Second Edition (r ρ = 0.54), Get Ready to Read! (r ρ = 0.87), and Pre-Reading Inventory of Phonological Awareness scores (r ρ = 0.64; all P < .001). These correlations remained statistically significant across age, sex, and SES groups. TRH scores were correlated with greater thickness in left-sided language and visual cortex (P-family-wise error <.05), which were similar for higher SES yet more bilateral and frontal for low SES, reflecting a less mature pattern (P-family-wise error <.10). CONCLUSIONS: These findings expand validation evidence for TRH as a screening tool for preschool-aged children, including associations with emergent skills and cortical thickness, and suggest important differences related to SES.

Feasibility study of the calm baby gently program: An educational baby book intervention on safe practices related to infant crying.

BACKGROUND: Abusive head trauma (AHT) is a preventable form of child abuse. OBJECTIVE: This project used a mixed method design to assess the feasibility of the Calm Baby Gently educational baby book intervention for promoting safe practices related to infant crying in an effort to prevent AHT. PARTICIPANTS AND SETTING: Three pediatric practices participated between June 2016 and January 2018, including 1045 caregivers who attended their infant's 2-month well-child visit. METHODS: Pediatric providers gave the educational baby book to caregivers at the 1-month well-child visit. Caregivers completed a survey at the 2-month well-child visit on their use and satisfaction with the book and responses to infant crying. Thematic analysis of qualitative feedback was performed. Responses to infant crying were compared quantitatively between caregivers who had and had not read the book. RESULTS: Of the 819 caregivers (78%) who received the book, 92% (754) read it, and 51% (421) had another caregiver read it. Caregivers considered the book approachable, understandable, validating, and helpful for improving knowledge and skills related to infant crying. The book was rated more helpful by caregivers of younger age, male gender, and non-white race. Controlling for age, gender, and race, caregivers who read the book were more confident (p = 0.033) and had more knowledge on how to respond appropriately to infant crying (p = 0.019) than caregivers who had not read it. CONCLUSIONS: Calm Baby Gently is a feasible and well-received AHT prevention program. Randomized controlled trials are needed to better understand its impact on knowledge, behavior, and AHT rates.

Shared reading quality assessment by parental report: preliminary validation of the DialogPR.

BACKGROUND: The American Academy of Pediatrics (AAP) recommends shared reading beginning as soon as possible after birth to promote healthy development. Shared reading quality can strongly influence outcomes, especially in children from low-SES households. Dialogic reading is a method developed to enhance verbal interactivity and engagement through book sharing, advocated by the AAP and clinic-based programs such as Reach Out and Read. There is no brief, validated, caregiver report measure of dialogic reading or shared reading quality currently available. METHODS: This cross-sectional study involved 49 healthy mother-child dyads (mean child age 4.5 yrs., SD = 0.6 yrs.) from 2 separate MRI-based studies. The DialogPR was administered by trained research coordinators following MRI, along with the READ subscale of the validated StimQ-P measure of home cognitive environment. The DialogPR consists of eight items developed in consultation with experts in early literacy, based on the PEER/CROWD dialogic reading conceptual model. Estimated reading level is 6th grade. Descriptive statistics were computed at both the item and scale levels. Modern theory Rasch methods were used to analyze all eight DialogPR items along with preliminary estimates of reliability and validity. RESULTS: Our combined sample involved 15 boys and 34 girls, and was diverse in terms of age, household income, and maternal education. DialogPR administration time was less than 2 min, with no problems reported. The DialogPR demonstrated strong internal consistency and reliability (Cronbach's alpha = 0.82), and criterion-related validity with the StimQ-P READ (Spearman's rho coefficient = 0.53). Rasch analysis revealed strong psychometric properties in terms of reliability, variability in item difficulty, and inter-item and item-measure correlations. CONCLUSIONS: Preliminary evidence suggests that the DialogPR may be an efficient means to assess shared reading quality and dialogic reading via caregiver report for clinical and research purposes, warranting further investigation.

A review of the economic tools for assessing new medical devices.

Whereas the economic evaluation of pharmaceuticals is an established practice within international health technology assessment (HTA) and is often produced with the support of comprehensive methodological guidance, the equivalent procedure for medical devices is less developed. Medical devices, including diagnostic products, are a rapidly growing market in healthcare, with over 10,000 medical technology patent applications filed in Europe in 2012-nearly double the number filed for pharmaceuticals. This increase in the market place, in combination with the limited, or constricting, budgets that healthcare decision makers face, has led to a greater level of examination with respect to the economic evaluation of medical devices. However, methodological questions that arise due to the unique characteristics of medical devices have yet to be addressed fully. This review of journal publications and HTA guidance identified these characteristics and the challenges they may subsequently pose from an economic evaluation perspective. These unique features of devices can be grouped into four categories: (1) data quality issues; (2) learning curve; (3) measuring long-term outcomes from diagnostic devices; and (4) wider impact from organisational change. We review the current evaluation toolbox available to researchers and explore potential future approaches to improve the economic evaluation of medical devices.

A comparison of pharmaceutical reimbursement agencies' processes and methods in France and Scotland.

OBJECTIVES: Pharmaceutical reimbursement agencies' processes and methods of appraisal vary across countries. The objective of this study was to examine the contribution of formal health economic analysis in a process using such analysis in Scotland in comparison to a process not routinely using such analysis in France. METHODS: A framework for classifying reimbursement systems was used to analyze the two systems. A typology of recommendation was defined and a qualitative analysis of decisions on a sample of medicines appraised by both reimbursement agencies was conducted. Reasons for differences in recommendations were analyzed and case studies selected to illustrate the common reasons. RESULTS: Thirty-nine common medicines appraised by both agencies were identified between 2005 and 2010, treating a variety of diseases for which the Scottish Medicines Consortium tended to provide more restrictive, or did not recommend, listing. Similarities in clinical evidence submitted to the respective reimbursement committees were observed. Differences in recommendation can be explained by a combination of the manufacturer's freedom to set price and the incentives provided by the consideration of health economic analysis and quality of life, alongside differences in relevant comparators, relevant outcomes, treatment guidelines, and the propensity to use network meta-analysis, in decision making. CONCLUSIONS: This study provides some explanations and hypotheses for the differences observed in recommendations for a selected sample of medicines with regards to differences in appraisal processes and methods adopted. Further research using larger datasets may allow stakeholders to assess the impact of such differences on the efficient use of health resources.

Cost-effectiveness of the Endeavor stent in de novo native coronary artery lesions updated with contemporary data.

AIMS: The Endeavor zotarolimus-eluting coronary stent has been shown to reduce the restenosis rate compared to bare metal stents and has impacted other clinical measures such as mortality, acute myocardial infarctions (AMI) and target vessel revascularisation (TVR). METHODS AND RESULTS: Using pooled efficacy data from the Endeavor clinical trial programme, a model was developed to compare the cost effectiveness of the Endeavor drug eluting stent (DES) with the Driver bare meal stent (BMS) over a four year time period. Endeavor was more costly but had an improved clinical outcome compared to Driver BMS over four years with a 4% reduction in deaths, 33% reduction in AMI and a 45% reduction in TVR. Late stent thrombosis was the only event showing an increased incidence for Endeavor of 0.2% compared to 0% for Driver. The incremental cost effectiveness ratio was pound3,757/quality adjusted life years (QALY). CONCLUSIONS: Although much controversy has surrounded the appropriate way to assess the cost effectiveness of DES technology, a comprehensive analysis is presented and this suggests that by using extended clinical trial data out to four years, the Endeavor DES in particular, but DES technologies in general, are cost-effective approaches to percutaneous coronary intervention.

The feasibility of harmonizing health technology assessments across jurisdictions: a case study of drug eluting stents.

OBJECTIVES: There is considerable interest in the potential for harmonizing health technology assessments (HTA) across jurisdictions. This study aims to consider four HTAs of drug eluting stents to determine the degree to which the methods adopted, evidence considered, and resulting recommendations diverge. METHODS: Four HTAs of drug eluting stents were selected for inclusion and evaluated using a framework developed to systematically capture information on the process adopted, the evidence considered and the recommendations of each HTA. RESULTS AND CONCLUSIONS: The findings suggest that, although there is a common core data set considered by most of the agencies, differences in the approach to HTA, heterogeneity of studies, and the limited relevance of research findings to local practice meant that the core data set had only limited influence on the resulting recommendations. Of the HTA agencies considered in the analysis, many sought to generate additional primary research from local settings to help inform the development of recommendations that were relevant to local practice. This raises questions about the extent to which HTA methods can be harmonized across jurisdictions.

Harmonization of evidence requirements for health technology assessment in reimbursement decision making.

As more countries use HTA to inform decisions on the reimbursement of health technologies, harmonization of evidence requirements between jurisdictions has been proposed, mainly on the grounds of improved efficiency. Harmonization has the potential to avoid duplication of effort for both manufacturers and HTA bodies involved in preparing and reviewing HTA submissions for innovative technologies. However, it also carries risks of loss of local control over decisions, the application of general data standards which are not universally accepted and slowing the rate of development of innovation in the analytical disciplines supporting HTA. This study reviews the issues associated with harmonization taking into account the perspectives of the multiple stakeholders. This study draws on experiences from recent initiatives intended to promote the harmonization of HTA and experience from related fields, particularly regulatory approval of new medical technologies.

Coverage with evidence development: an examination of conceptual and policy issues.

The application of conditionality to coverage decisions for healthcare technologies is increasing. Coverage with Evidence Development (CED) represents a specific approach to coverage for promising technologies for which the evidence remains uncertain. CED demands that additional evidence is generated to address the sources of uncertainty and secure ongoing coverage. This study explores the conceptual and policy issues relating to CED and discusses issues involved in operationalizing CED in practice, including presenting criteria for which technologies may be most suitable for CED. This study is intended to further the debate on the use of CED as well as highlight areas that warrant further research.

Framework for describing and classifying decision-making systems using technology assessment to determine the reimbursement of health technologies (fourth hurdle systems).

OBJECTIVES: Australia, Canada, and many European countries now use various forms of health technology assessment (HTA) in decision making regarding the reimbursement of drugs and other health technologies. To achieve a better understanding of the potential for use of HTA in this context, an analytical framework was developed to describe and classify existing fourth hurdle systems. METHODS: Based on a review of published literature, and official documentation, the key aspects of a fourth hurdle system were identified at two levels: policy implementation and individual technology decision. Characteristics of the systems were grouped under four main headings: constitution and governance, objectives, use of evidence and decision processes, and accountability. The comprehensiveness and relevance of this framework was assessed by an independent group of experts in HTA. A pilot study was undertaken, using only published sources, to test the feasibility of obtaining the information needed to complete the framework. RESULTS: The framework was found to be sufficiently broad to encompass all the issues of interest regarding the systems, but the proportion of information available from published sources was variable between sections of the framework and between countries, with average availability of 45 percent. CONCLUSIONS: The analytical framework will help researchers and policy makers in individual countries to understand their own systems and will allow some preliminary sharing of experience between countries. More experience of its application is needed to judge whether it will provide the basis for more formal comparison of systems and whether it will determine their appropriateness for particular decision contexts.

Cost-effectiveness of oral ibandronate versus IV zoledronic acid or IV pamidronate for bone metastases in patients receiving oral hormonal therapy for breast cancer in the United Kingdom.

BACKGROUND: Oral ibandronate is a single-nitrogen bisphosphonate whose efficacy is similar to that of IV ibandronate for the treatment of bone metastases. OBJECTIVE: The aim of this study was to compare the cost-effectiveness of oral ibandronate with zoledronic acid and generic pamidronate (both administered by IV) for the treatment of bone metastases in patients with breast cancer receiving oral hormonal therapy in the United Kingdom. METHODS: A global economic model was adapted to the UK National Health Service. Patients were assumed to receive oral hormonal therapy for 50% of their projected 14.3-month survival. The primary outcome was incremental cost per quality-adjusted life-year (QALY). Bisphosphonate efficacy data for relative risk reduction of skeletal-related events (SREs) were obtained from clinical trials. Resource use data and costs associated with IV bisphosphonate infusions were derived from published studies and a unit cost database; monthly drug acquisition costs were obtained from the British National Formulary. Utility scores were applied to time with or without an SRE to adjust survival for quality of life. Therefore, differences in QALYs were driven by utility weights rather than survival time. Model design and inputs were validated through expert UK clinician review. The absence of comparative efficacy and safety data from clinical trials for the different bisphosphonates was a model limitation that we addressed by supporting our assumptions with UK expert clinician opinion and with expert clinician opinion outside of the United Kingdom, and by conducting sensitivity analyses. RESULTS: The projected total cost per patient was pound307 less with oral ibandronate compared with zoledronic acid, and pound158 less compared with the use of generic pamidronate (due to a reduction in staff time for infusions, avoidance of renal safety monitoring visits, and, in the case of IV generic pamidronate, a reduction in the number of SREs). Oral ibandronate was estimated to lead to a gain of 0.02 QALY, making it the economically dominant treatment option. CONCLUSIONS: In this study, we found that oral ibandronate was cost-effective for the management of bone metastases from breast cancer among patients receiving oral hormonal therapy in the United Kingdom. Oral ibandronate provided effective SRE and bone-pain management while avoiding resource use and costs associated with regular IV bisphosphonate infusions. Due to uncertainty surrounding the model assumptions, it would be valuable to repeat the analyses using data from comparative bisphosphonate trials, once they become available.

Selecting methods for the prediction of future events in cost-effectiveness models: a decision-framework and example from the cardiovascular field.

Evidence on the cost-effectiveness of healthcare interventions is increasingly required by decision-makers. Economic models can provide timely information on the long-term impact of new technologies. However, models have been criticised because of the implicit assumptions they make, in particular the methods used to extrapolate data are rarely documented. This paper presents a systematic process for choosing a method of predicting events in economic models. This process is illustrated using a model examining the cost-effectiveness of a new HMG-CoA reductase inhibitor (statin) for primary prevention of cardiovascular disease (CVD). The prediction of future CVD events is a central component of the model, and the choice of method for predicting events was an important issue in the model's development. A literature review identified 11 studies with the information required to predict CVD events. A set of criteria were developed to assess the different methods of risk estimation, covering issues like scientific validity and acceptability to decision-makers. Risk equations derived from the Framingham Heart Study were found to be most suitable for predicting future events in the economic model. The paper illustrates how the development of economic models can be made more transparent, and suggests that the process outlined may be applied to other disease areas where there are several event prediction methods to choose from. In disease areas where published methods for predicting events are not available, the process outlined can make the uncertainty this leads to explicit, and highlight where further research is required. Such transparency can help decision-makers understand the scientific basis underpinning models, and therefore make these models more acceptable and useful for health policy-making.

Regulating the economic evaluation of pharmaceuticals and medical devices: a European perspective.

Throughout the developed world, economic evaluation of costly new pharmaceuticals and medical devices became increasingly widespread and systematic during the 1990s. However, serious concerns remain about the validity and relevance of this economic evidence, and about the transparency and accountability of its use in public sector reimbursement decisions. In this article, we summarise current concerns in Europe, based on interviews with European health economists from industry, universities, research institutes and consulting firms. We identify five challenges for European policy-makers, and conclude that there is considerable scope for improving decision-making without damaging incentives to innovate. The challenges are: (1). full publication of the economic evidence used in reimbursement decisions; (2). the redesign of licensing laws to improve the relevance of economic data available at product launch; (3). harmonisation of economic evaluation methodologies; (4). development of methodologies for evaluation of health inequality impacts; and (5). negotiation of price-performance deals to facilitate the use of economic evidence in post-launch pricing review decisions, as information is gathered from studies of product performance in routine use.