Associations of social and cognitive-behavioral variables with disinhibited eating and anxiety: An ecological momentary assessment study.

OBJECTIVE: Among adolescents, disinhibited eating and anxiety commonly co-occur. Precision intervention approaches targeting unique mechanistic vulnerabilities that contribute to disinhibited eating and anxiety may therefore be helpful. However, the effectiveness of such interventions hinges on knowledge of between- and within-person associations related to disinhibited eating, anxiety, and related processes. METHOD: A sample of 39 adolescent females (12-17 years) with elevated anxiety and above-average weight (BMI %ile ≥ 75th) completed measures of theoretically driven social and cognitive-behavioral variables, disinhibited eating, and anxiety via ecological momentary assessment over 7 days. Data were analyzed using mixed-effects models. RESULTS: Between-person differences in social stressors were linked to emotional eating, eating in the absence of hunger, and anxiety, whereas between-person differences in negative thoughts were associated with all disinhibited eating variables and anxiety. Between-person differences in avoidance were not related to any outcome. Additionally, between-person differences in social stressors and negative thoughts-as well as within-person deviations (from person-average levels) of social stressors, negative thoughts, and avoidance-were associated with anxiety. In turn, between-person differences in anxiety predicted eating in the absence of hunger and emotional eating, and within-person deviations in anxiety were associated with emotional eating at any given time point. DISCUSSION: Findings support elements of both the interpersonal and cognitive-behavioral models of disinhibited eating. Differential trigger effects on anxiety, both at the between- and within-person levels, and significant associations between anxiety and all eating-related outcomes, highlight the potential utility of interventions targeting individual differences in sensitivity to anxiety triggers. PUBLIC SIGNIFICANCE: Findings provide support for the interpersonal and cognitive-behavioral models of disinhibited eating, highlighting anxiety as a salient vulnerability and potential mechanistic factor underlying disinhibited eating. Social, cognitive, and behavioral variables were differentially related to anxiety across participants, suggesting potential for future intervention tailoring and intervention selection based on adolescents' sensitivity to anxiety as a trigger for disinhibited eating behavior.

Carotid Intima-Media Thickness and Improved Stroke Risk Assessment in Hypertensive Black Adults.

BACKGROUND: We aim to determine the added value of carotid intima-media thickness (cIMT) in stroke risk assessment for hypertensive Black adults. METHODS: We examined 1,647 participants with hypertension without a history of cardiovascular (CV) disease, from the Jackson Heart Study. Cox regression analysis estimated hazard ratios (HRs) for incident stroke per standard deviation increase in cIMT and quartiles while adjusting for baseline variables. We then evaluated the predictive capacity of cIMT when added to the pool cohort equations (PCEs). RESULTS: The mean age at baseline was 57 ± 10 years. Each standard deviation increase in cIMT (0.17 mm) was associated with approximately 30% higher risk of stroke (HR 1.27, 95% confidence interval: 1.08-1.49). Notably, cIMT proved valuable in identifying residual stroke risk among participants with well-controlled blood pressure, showing up to a 56% increase in the odds of stroke for each 0.17 mm increase in cIMT among those with systolic blood pressure <120 mm Hg. Additionally, the addition of cIMT to the PCE resulted in the reclassification of 58% of low to borderline risk participants with stroke to a higher-risk category and 28% without stroke to a lower-risk category, leading to a significant net reclassification improvement of 0.22 (0.10-0.30). CONCLUSIONS: In this community-based cohort of middle-aged Black adults with hypertension and no history of CV disease at baseline, cIMT is significantly associated with incident stroke and enhances stroke risk stratification.

Measuring civilian moral injury: Adaptation and validation of the Moral Injury Events Scale (Civilian) and Expressions of Moral Injury Scale (Civilian).

OBJECTIVE: Moral injury (MI) research has been expanded to populations beyond the military in recent years. A key barrier to further research into MI in civilian populations is the lack of valid, reliable measures of the construct appropriate for general civilian use. This article addresses this barrier by adapting two existing military measures and exploring their psychometrics in a general civilian sample: the Moral Injury Events Scale-Civilian (MIES-C) and Expressions of Moral Injury Scale-Military (EMIS-C). METHOD: A sample of civilian women (n = 192) and men (n = 88) completed the above measures, and additional scales designed to capture theoretically supported primary and secondary markers of MI (guilt, shame, anger; depression, posttraumatic stress symptoms, anxiety). RESULTS: Confirmatory factor analyses found that the factor structure of the MIES-C and EMIS-C replicated well within our civilian sample. Discriminant validity was indicated through a significant negative correlation with well-being. Both measures correlated as predicted with each other and measures of MI markers at the total score level. Correlations of individual subscales with each of these measures were more varied. CONCLUSIONS: Results shed light on differential relationships between the type of MI event and clinical outcomes, suggesting some conceptual differences in how MI is experienced in general civilian populations. Results suggest that civilian populations are also susceptible to MI, but that existing measures may have problems capturing this effectively. While the MIES-C and EMIS-C are supported for civilian use, further scale construction efforts for this population are warranted. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Metabolite Signature of Life's Essential 8 and Risk of Coronary Heart Disease Among Low-Income Black and White Americans.

BACKGROUND: Life's essential 8 (LE8) is a comprehensive construct of cardiovascular health. Yet, little is known about the LE8 score, its metabolic correlates, and their predictive implications among Black Americans and low-income individuals. METHODS: In a nested case-control study of coronary heart disease (CHD) among 299 pairs of Black and 298 pairs of White low-income Americans from the Southern Community Cohort Study, we estimated LE8 score and applied untargeted plasma metabolomics and elastic net with leave-one-out cross-validation to identify metabolite signature (MetaSig) of LE8. Associations of LE8 score and MetaSig with incident CHD were examined using conditional logistic regression. The mediation effect of MetaSig on the LE8-CHD association was also examined. The external validity of MetaSig was evaluated in another nested CHD case-control study among 299 pairs of Chinese adults. RESULTS: Higher LE8 score was associated with lower CHD risk (standardized odds ratio, 0.61 [95% CI, 0.53-0.69]). The MetaSig, consisting of 133 metabolites, showed significant correlation with LE8 score (r=0.61) and inverse association with CHD (odds ratio, 0.57 [0.49-0.65]), robust to adjustment for LE8 score and across participants with different sociodemographic and health status ([odds ratios, 0.42-0.69]; all P<0.05). MetaSig mediated a large portion of the LE8-CHD association: 53% (32%-80%). Significant associations of MetaSig with LE8 score and CHD risk were found in validation cohort (r=0.49; odds ratio, 0.57 [0.46-0.69]). CONCLUSIONS: Higher LE8 score and its MetaSig were associated with lower CHD risk among low-income Black and White Americans. Metabolomics may offer an objective measure of LE8 and its metabolic phenotype relevant to CHD prevention among diverse populations.

Community-Based Interventions to Address Disparities in Cardiometabolic Diseases Among Minoritized Racial and Ethnic Groups.

PURPOSE OF REVIEW: Cardiometabolic diseases (CMDs) are leading causes of death and disproportionally impact historically marginalized racial/ethnic groups in the United States. The American Heart Association developed the Life's Essential 8 (LE8) to promote optimal cardiovascular health (CVH) through eight health behaviors and health factors. The purpose of this review is to summarize contemporary community-engaged research (CER) studies incorporating the LE8 framework among racial/ethnic groups. REVIEW OF FINDINGS: Limited studies focused on the interface of CER and LE8. Based on synthesis of articles in this review, the application of CER to individual/collective LE8 metrics may improve CVH and reduce CMDs at the population level. Effective strategies include integration of technology, group activities, cultural/faith-based practices, social support, and structural/environmental changes. CER studies addressing LE8 factors in racial/ethnic groups play an essential role in improving CVH. Future studies should focus on broader scalability and health policy interventions to advance health equity.

Loss of control eating in relation to blood pressure among adolescent girls with elevated anxiety at-risk for excess weight gain.

Loss of control (LOC)-eating, excess weight, and anxiety are robustly linked, and are independently associated with markers of poorer cardiometabolic health, including hypertension. However, no study has examined whether frequency of LOC-eating episodes among youth with anxiety symptoms and elevated weight status may confer increased risk for hypertension. We examined the relationship between LOC-eating frequency and blood pressure among 39 adolescent girls (14.9 ± 1.8 years; body mass index [BMI] = 29.9 ± 5.6; 61.5 % White; 20.5 % African American/Black; 5 % Multiple Races; 2.5 % Asian; 12.8 % Hispanic/Latino; 30.8 % with reported LOC-eating) with elevated anxiety and above average BMI who enrolled in a clinical trial aimed at preventing excess weight gain. LOC-eating over the past three months was assessed via clinical interview, and blood pressure (systolic and diastolic) was measured with an automatic blood pressure monitor. Adjusting for age, fat mass, and height, LOC-eating episode frequency was significantly, positively associated with diastolic blood pressure (ß = 0.38, p = 0.02), but not with systolic blood pressure (ß = 0.13, p = 0.41). Replication studies, with larger sample sizes, participants of varying weight-strata, and prospective data are required to elucidate the relationship between LOC-eating and cardiovascular functioning in youth with elevated anxiety.

Metabolite Signature of Life's Essential 8 and Risk of Coronary Heart Disease among Low-Income Black and White Americans.

Background and Aims: Life's Essential 8 (LE8) is a comprehensive construct of cardiovascular health. Yet, little is known about LE8 score, its metabolic correlates, and their predictive implications among Black Americans and low-income individuals. Methods: In a nested case-control study of coronary heart disease (CHD) among 598 Black and 596 White low-income Americans, we estimated LE8 score, conducted untargeted plasma metabolites profiling, and used elastic net with leave-one-out cross-validation to identify metabolite signature (MetaSig) of LE8. Associations of LE8 score and MetaSig with incident CHD were examined using conditional logistic regression. Mediation effect of MetaSig on the LE8-CHD association was also examined. The external validity of MetaSig was evaluated in another nested CHD case-control study among 598 Chinese adults. Results: Higher LE8 score was associated with lower CHD risk [standardized OR (95% CI)=0.61 (0.53-0.69)]. The identified MetaSig, consisting of 133 metabolites, showed strong correlation with LE8 score ( r =0.61) and inverse association with CHD risk [OR (95% CI)=0.57 (0.49-0.65)], robust to adjustment for LE8 score and across participants with different sociodemographic and health status (ORs: 0.42-0.69; all P <0.05). MetaSig mediated a large portion of the LE8-CHD association: 53% (32%-80%) ( P <0.001). Significant associations of MetaSig with LE8 score and CHD risk were found in validation cohort [ r =0.49; OR (95% CI)=0.57 (0.46-0.69)]. Conclusions: Higher LE8 score and its MetaSig were associated with lower CHD risk among low-income Black and White Americans. Metabolomics may offer an objective and comprehensive measure of LE8 score and its metabolic phenotype relevant to CHD prevention among diverse populations.

A Comparison of Experiences with Factors Related to Food Insecurity between College Students Who Are Food Secure and Food Insecure: A Qualitative Study.

BACKGROUND: Previous research has reported negative health consequences and poor academic achievement among college students who are food insecure. It is unknown if students with food insecurity's experiences qualitatively differ from students who are food secure. OBJECTIVE: To qualitatively evaluate experiences of students who are food secure and food insecure with internal and external factors related to food insecurity. DESIGN: Trained interviewers conducted in-person qualitative interviews from February to August 2018 to gain insights about eating patterns, food environment, financial situation, and ideas for addressing food insecurity on college campuses with students who are food secure and food insecure. PARTICIPANTS AND SETTING: Students from three universities in the western United States (N = 58) who were classified as food secure (n = 28) and food insecure (n = 30) using the US Department of Agriculture's 6-item Food Security Module participated in this study. STATISTICAL ANALYSES PERFORMED: Interviews were recorded and transcribed verbatim. Data were analyzed using a conventional content analysis. A random sample of transcripts were independently coded to determine interrater reliability. Researchers divided transcripts for final coding and overarching themes were discussed. Descriptive statistics were used. RESULTS: Students who were both food secure and food insecure obtained food from similar sources (eg, grocery stores); had unexpected expenses that led to financial constraints; indicated transportation barriers altered the amount or package size of food purchased; and reported similar knowledge, attitudes, use, and familial history of food assistance. Students with food insecurity uniquely reported prioritizing rent or other living expenses over food, and when funds were low, reducing food intake, experiencing a variable food supply throughout the month, or using strategies like donating plasma or selling possessions to enhance financial stability. CONCLUSIONS: This study helps nutrition and dietetics practitioners better understand how college students' experiences with factors related to food insecurity differ by food security status. Future quantitative research is needed to confirm the coping strategies identified among students with food insecurity in this study.

Addressing Anxiety and Stress for Healthier Eating in Teens (ASSET): A Pilot Randomized Controlled Trial Protocol for Reducing Anxiety, Disinhibited Eating, Excess Weight Gain, and Cardiometabolic Risk in Adolescent Girls.

(1) Background: Standard-of-care lifestyle interventions show insufficient effectiveness for the prevention and treatment of excess weight and its associated cardiometabolic health concerns in adolescents, necessitating more targeted preventative approaches. Anxiety symptoms are common among adolescents, especially girls at risk for excess weight gain, and have been implicated in the onset and maintenance of disinhibited eating. Thus, decreasing elevated anxiety in this subset of adolescent girls may offer a targeted approach to mitigating disinhibited eating and excess weight gain to prevent future cardiometabolic health problems. (2) Methods: The current paper describes the protocol for a multisite pilot and feasibility randomized controlled trial of group cognitive behavioral therapy (CBT) and group interpersonal psychotherapy (IPT) in N = 40 adolescent girls (age 12-17 years) with elevated anxiety symptoms and body mass index (BMI; kg/m2) ≥ 75th percentile for age/sex. (3) Results: Primary outcomes are multisite feasibility of recruitment, protocol procedures, and data collection, intervention fidelity, retention at follow-ups, and acceptability of interventions and study participation. (4) Conclusions: Findings will inform the protocol for a future fully-powered multisite randomized controlled trial to compare CBT and IPT efficacy for reducing excess weight gain and preventing adverse cardiometabolic trajectories, as well as to evaluate theoretically-informed treatment moderators and mediators.

Values, principles, strategies, and frameworks underlying patient and public involvement in health technology assessment and guideline development: a scoping review.

The importance of patient and public involvement (PPI) is recognized by agencies involved in health technology assessment (HTA) and guideline development. However, a comprehensive overview of the underlying PPI principles, values, strategies, and frameworks is lacking. This scoping review aimed to summarize the available evidence on principles, values, frameworks, and strategies underpinning PPI carried out by agencies involved in HTA and guideline development. A total of twelve records were included, of which four referred to guidelines and eight to HTA. Overall, this review demonstrated a lack of consistency in the definition and application of the concepts of values and principles to PPI in the context of guideline development and HTA. There was significant overlap between values and principles, with some broad themes emerging, such as representation, transparency, relevance, equity, fairness, and reconciling different types of knowledge. Frameworks were typically based on the stages of guideline development or HTA, despite heterogeneity in how stages were labeled and described. Strategies were also mapped to the stages of guideline development and HTA and varied substantially depending on the context and setting. Both strategies and frameworks demonstrated patients and the public can be involved, albeit to a variable extent, throughout the stages of guideline development and HTA. However, frameworks often failed to explicitly link the values and principles with the HTA and guideline development stages through actionable PPI strategies. Further research is warranted to better understand the values, principles, and frameworks underpinning PPI in guideline development and HTA.

Implementing shared decision-making in UK: Progress 2017-2022.

Shared decision making has been on the policy agenda in the UK for at least twelve years, but it lacked a comprehensive approach to delivery. That has changed over the past five years, and we can now see significant progress across all aspects of a comprehensive approach, including leadership at policy, professional and patient levels; infrastructure developments, including the provision of training, tools and campaigns; and practice improvements, such as demonstrations, measurement and coordination. All these initiatives were necessary, but the last, central coordination, would appear to be key to success.

Enhanced rapid review of the applicability of ultrasound in the assessment of sucking, swallowing and laryngeal function in the paediatric population.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has renewed interest in the use of ultrasound (US) amongst dysphagia-trained clinicians working with infants and children. US is a portable, minimally intrusive tool which carries reduced risk of aerosol-generation provoked by other instrumental swallowing assessment tools such as fibreoptic endoscopic evaluation of swallowing (FEES). For this reason, US could be a valuable addition to the dysphagia assessment toolkit. A recently published rapid review of US evidence for the assessment of swallowing and laryngeal function in the adult population provided a framework for this neonatal and paediatric review. AIMS: This enhanced rapid review aimed to establish the applicability of US as an instrumental assessment tool for sucking, swallowing and laryngeal function in the neonatal and paediatric populations. METHODS & PROCEDURES: A rapid review of six electronic databases was conducted to identify articles using US to assess sucking, swallowing or laryngeal function in the selected populations, compared with varied reference tests. Abstract screening was completed according to pre-defined inclusion/exclusion criteria with 10% of articles assessed by a second screener. Data was extracted from the included studies using a pre-developed form. A modified QUADAS-2 tool was used to assess study quality. Results from the included studies were summarised and grouped into sucking, swallowing and laryngeal function data. OUTCOMES & RESULTS: Twelve studies using US in the assessment of swallowing and/or laryngeal function met inclusion criteria. No studies using US for assessment of sucking met the inclusion criteria. All were peer-reviewed, primary studies across a range of clinical populations and with a wide geographical spread. Five studies had an overall low risk of bias. Seven studies had at least one domain where risk of bias was judged as high. All studies had high applicability. The two studies assessing swallowing differed in terms of aims and use of US. The studies assessing laryngeal function predominately investigated vocal fold movement and laryngeal pathology. Sensitivity and specificity data were provided or calculated from raw data for nine of the laryngeal function studies (respective ranges of 75%-100% and 80%-100%). CONCLUSIONS & IMPLICATIONS: Emerging evidence exists to support the use of US as adjunct to clinical assessment of swallowing and laryngeal function in the neonatal and paediatric population. A paucity of evidence to support use of US in the assessment of sucking exists. Further research is needed to establish evidence-based assessment and analysis protocols as well as development of paediatric data.

The Cedar Project: exploring the role of colonial harms and childhood maltreatment on HIV and hepatitis C infection in a cohort study involving young Indigenous people who use drugs in two Canadian cities.

OBJECTIVES: This study examined associations between childhood maltreatment, colonial harms and sex/drug-related risks for HIV and hepatitis C virus (HCV) infection among young Indigenous people who use drugs. DESIGN: The Cedar Project is a cohort involving young Indigenous people who use drugs in British Columbia (BC), Canada. Indigenous collaborators, collectively known as the Cedar Project Partnership, govern the entire research process. SETTING: Vancouver is a large city on the traditional territory of the Coast Salish peoples. Prince George is a mid-sized city, on the traditional territory of Lheidli T'enneh First Nation. PARTICIPANTS: 420 participants completed the Childhood Trauma Questionnaire and returned for follow-up from 2003 to 2016. PRIMARY/SECONDARY OUTCOME MEASURES: Primary outcomes were HIV and HCV infection over the study period. Secondary outcomes included sex and substance use-related risks. RESULTS: Prevalence of childhood maltreatment was 92.6% experienced any maltreatment; 73.4% experienced emotional abuse; 62.6% experienced physical abuse; 60.3% experienced sexual abuse; 69.5% experienced emotional neglect and 79.1% experienced physical neglect. We observed significant associations between childhood maltreatment and apprehensions into residential schools and foster care. All maltreatment types were associated with higher odds of sex/substance use-related risks; sexual abuse was associated with higher odds of HCV infection (adjusted OR: 1.67; 95% CI 1.05 to 2.66; p=0.031). CONCLUSIONS: Findings reflect high prevalence of childhood maltreatment and their associations with HIV/HCV risk and HCV infection. Public health prevention and treatment initiatives must be trauma informed and culturally safe to support healing, health, and well-being.

The Cedar Project: Relationship between child apprehension and attempted suicide among young Indigenous mothers impacted by substance use in two Canadian cities.

Indigenous leaders are gravely concerned over disproportionate representation of Indigenous children in Canada's child welfare systems. Forced separation from children is deeply traumatizing for mothers and detrimental to the wellbeing of Indigenous families, communities and Nations. This study examined relationships between child apprehension and suicide attempt within a cohort of young Indigenous women impacted by substance use. We utilized data collected every 6 months (2008-2016) by the Cedar Project, an Indigenous-governed cohort study involving young Indigenous people who use drugs in British Columbia, Canada. Recent child apprehension was defined as having a child apprehended by the Ministry of Child and Family Development since last visit. Recurrent event Cox proportional hazards models estimated the independent effect of child apprehension on maternal suicide attempt. Among 293 participants, 78 (27%) reported 136 child apprehensions; incidence of first apprehension was 6.64 (95%CI: 5.25-8.29) per 100 person-years. Forty-seven (16%) participants reported 75 suicide attempts with an incidence of 4.00 (95%CI: 2.94-5.33) per 100 person-years. Participants who reported recent child apprehension (HR: 1.88, 95%CI: 1.00-3.55), had a parent attend residential school (HR: 4.12, 95%CI: 1.63-10.46), experienced recent sexual assault (HR: 4.04, 95%CI: 2.04-7.99), violence (HR: 2.54, 95%CI: 1.52-4.27) or overdose (HR: 4.97, 95%CI: 2.96-8.35) were more likely to attempt suicide. Participants who had a traditional language spoken in the home growing up were half as likely to attempt suicide (HR: 0.49, 95%CI: 0.23-1.01). Results suggest that child welfare systems in Canada perpetuate historical and intergenerational trauma among young Indigenous mothers. Indigenous self-determination over child welfare and culturally safe services are urgently needed to end cycles of child apprehension and support the wellbeing of families, communities and Nations.

Development and evaluation of 'Sleep, Baby & You'-An approach to supporting parental well-being and responsive infant caregiving.

Disrupted parental sleep, presenting as post-partum fatigue and perceived as problematic infant sleep, is related to increased symptoms of depression and anxiety among new mothers and fathers. Previous research indicates that UK parents would value an approach that facilitates meeting their infants' needs while supporting their own sleep-related well-being throughout their infant's first year. Six initial stakeholder meetings were held with 15 practitioners and 6 parents with an interest in supporting parent-infant sleep needs, to explore existing service provision and identify gaps. The Possums Sleep Program developed and delivered in Brisbane, Australia in a GP clinic setting, was chosen as an appropriate approach. Working collaboratively with a stakeholder group, we translated the Possums Sleep Program into an intervention that could be universally delivered in the UK via NHS antenatal and postnatal practitioners. Parent and practitioner views of the initial materials were obtained via feedback questionnaires and the tool was revised. The intervention was then field-tested by 164 practitioners who delivered it to at least 535 new parents and babies over 5 UK locations, to capture anonymous parent and practitioner views of the intervention concept, the materials, and their experiences with both. The intervention helps parents recalibrate their expectations of infant sleep development, encourages responsive parenting and experimentation to meet their infant's needs, offers parents strategies for supporting the development of their babies' biological sleep regulators and promote their own well-being, and teaches parents to manage negative thinking and anxiety that can impede sleep using the principles of Acceptance and Commitment Therapy. The 'Sleep, Baby & You' discussion tool, a 14 page illustrated booklet for parents, was field-tested and evaluated by practitioners and parents who offered enthusiastic feedback. Practitioners reported the 'Sleep, Baby & You' materials were easy for them to explain and for parents to understand, and were a good fit with the responsive parenting approaches they employed in other areas of their work. Parents who received the intervention postnatally understood the material and found the suggestions easy to follow. All parents who provided feedback had implemented one or more of the suggested changes, with the majority of changes (70%) being sustained for at least two weeks. Practitioners recommended development of digital and antenatal versions and offered feedback on circumstances that might challenge effective uptake of the intervention. 'Sleep, Baby & You' is a promising tool for promoting parental attitude and behaviour-change, that aims to adjust parental expectations and reduce negative thinking around infant sleep, promote responsive infant care in the face of infant-related sleep disruption and fatigue, and support parental well-being during the first year of parenthood. Initial field-testing provided insights useful for further development and subsequent testing via a randomised trial. Support exists for incorporating 'Sleep, Baby & You' into an anticipatory, universal intervention to support parents who may experience post-partum fatigue and infant sleep disruption.

Non-invasive molecular assessment of human embryo development and implantation potential.

In vitro fertilization (IVF) is the most common assisted reproductive technology used to treat infertility. Embryo selection for transfer in IVF cycles relies on the morphological evaluation by embryologists, either by conventional microscopic assessment or more recently by time-lapse imaging systems. Despite the introduction of time-lapse imaging improvements in IVF success rates have failed to materialize, therefore alternative approaches are needed. Recent studies have shown that embryos resulting in successful pregnancy differ in their secretome and metabolism compared to embryos that fail to implant, suggesting that molecular analysis of embryo culture medium could assist in non-invasive single embryo selection. However, this approach has yet to be adopted clinically due to the lack of appropriate highly sensitive screening technologies needed to assess volume-limited samples. Here we report the detection of hCGß, IL-8 and TNFα from conditioned culture media of single human embryos using electrochemical impedance spectroscopy. The impedimetric immunosensors revealed that morphologically non-viable embryos produce higher levels of IL-8 and TNFα, associated with abnormal cell division and cell death, respectively. More importantly, hCGß detection was able to discriminate apparently morphologically identical viable embryos. This work brings an objective dimension to embryo selection, which could overcome the major limitations of morphology-based embryo selection for implantation. Future work should include the validation of these biomarkers in a large patient cohort.

Amyloidosis: diagnosis and new therapies for a misunderstood and misdiagnosed disease.

Amyloidosis is a group of diseases characterized by extracellular deposition of amyloid fibril complexes. Fibril deposition results in organ dysfunction and possible failure. Amyloidosis is regarded as a rare disease, but in general is underdiagnosed. The two main types of systemic amyloidosis are immunoglobulin light chain and transthyretin amyloidosis. The increased availability of noninvasive cardiac imaging, genetic testing and improved laboratory assays and protein identification methods have led to increased diagnosis. However, in many cases, the diagnosis is not made until the patient develops organ impairment. Earlier diagnosis is required to prevent irreversible organ failure. Novel treatments for immunoglobulin light chain and transthyretin amyloidosis that halt disease progression, prolong and increase quality of life have recently become available.

EUPATI Guidance for Patient Involvement in Medicines Research and Development: Health Technology Assessment.

The main aim of health technology assessment (HTA) is to inform decision making by health care policy makers. It is a systematic process that evaluates the use of health technologies and generally involves a critical review of international evidence related to clinical effectiveness of the health technology vs. the best standard of care. It can also include an evaluation of cost effectiveness, and social and ethical impacts in the local health care system. The HTA process advises whether or not a health technology should be used, and if so, how it is best used and which patients are most likely to benefit from it. The importance of patient involvement in HTA is becoming widely recognized, for scientific and democratic reasons. The extent of patient involvement in HTA varies considerably across Europe. Commonly HTA is still focused on quantitative evidence to determine clinical and/or cost effectiveness, but the interest in understanding patients' experiences and preferences is increasing. Some HTA bodies provide support for participation in their processes, but again this varies widely across Europe. The involvement of patients in HTA is determined at the national and regional level, and is not subject to any European-wide legislation. The guidance text presented in this article was developed as part of the work of the European Patients' Academy on Therapeutic Innovation (EUPATI) and covers the interaction between HTA bodies and patients and their representatives when medicines are being assessed. Other EUPATI guidance documents relate to patient involvement in pharmaceutical industry-led research and development, ethics committees, and regulatory authorities. The guidance provides recommendations for activities to support patient involvement in HTA bodies and specific guidance for individual HTA processes. It seeks to improve patient involvement, using the outcomes of published research and consensus-building exercises. It also draws on good practice examples from individual HTA bodies. The guidance is not intended to be prescriptive and should be used according to specific circumstances, national legislation, or the unique needs of each interaction. This article represents the formal publication of the HTA guidance text with discussion about recent progress in, and continuing barriers to, patient involvement in HTA.

Putting Patients at the Centre of Healthcare: Progress and Challenges for Health Technology Assessments.

Health technology assessments (HTAs) are meant to inform health policy by taking account of all the potential impacts of using a health technology. In the 1990s, HTAs included rigorous research to produce patient-based evidence, and some supported participation of patient representatives to help focus HTA research and determine value. In the 2000s, HTAs became more closely linked to reimbursement decisions, focusing on clinical and cost effectiveness. Patient involvement should be tailored to the specific needs of each HTA. As the timeframe for HTAs has reduced, research to produce patient-based evidence has been replaced by input from patient groups. This places a burden on individuals and organizations that needs to be critically reviewed. Therefore, it is imperative that we clarify when patient involvement is likely to add value and support patients to provide their unique knowledge in the most optimal way to influence HTA decision making. To reduce the burden on patient groups, more must be done to encourage research to produce patient-based evidence early in technology development. Like clinical research, a programme of research should be carefully planned, with appropriate methodological rigor for each study, and all research should be published. For this, the development of quality standards for research to produce patient-based evidence may be needed. Patient involvement has inherent value. It should be focused, systematic and transparent, and evolve according to the experiences of all stakeholders. All countries or collaboratives that undertake HTA should consider how they can elicit the needs, preferences and experiences of patients to support creation of patient-centered healthcare policy.