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Substantial progress has been made in the standardization of nomenclature for paediatric and congenital cardiac care. In 1936, Maude Abbott published her Atlas of Congenital Cardiac Disease, which was the first formal attempt to classify congenital heart disease. The International Paediatric and Congenital Cardiac Code (IPCCC) is now utilized worldwide and has most recently become the paediatric and congenital cardiac component of the Eleventh Revision of the International Classification of Diseases (ICD-11). The most recent publication of the IPCCC was in 2017. This manuscript provides an updated 2021 version of the IPCCC.
The International Society for Nomenclature of Paediatric and Congenital Heart Disease (ISNPCHD), in collaboration with the World Health Organization (WHO), developed the paediatric and congenital cardiac nomenclature that is now within the eleventh version of the International Classification of Diseases (ICD-11). This unification of IPCCC and ICD-11 is the IPCCC ICD-11 Nomenclature and is the first time that the clinical nomenclature for paediatric and congenital cardiac care and the administrative nomenclature for paediatric and congenital cardiac care are harmonized. The resultant congenital cardiac component of ICD-11 was increased from 29 congenital cardiac codes in ICD-9 and 73 congenital cardiac codes in ICD-10 to 318 codes submitted by ISNPCHD through 2018 for incorporation into ICD-11. After these 318 terms were incorporated into ICD-11 in 2018, the WHO ICD-11 team added an additional 49 terms, some of which are acceptable legacy terms from ICD-10, while others provide greater granularity than the ISNPCHD thought was originally acceptable. Thus, the total number of paediatric and congenital cardiac terms in ICD-11 is 367. In this manuscript, we describe and review the terminology, hierarchy, and definitions of the IPCCC ICD-11 Nomenclature. This article, therefore, presents a global system of nomenclature for paediatric and congenital cardiac care that unifies clinical and administrative nomenclature.
The members of ISNPCHD realize that the nomenclature published in this manuscript will continue to evolve. The version of the IPCCC that was published in 2017 has evolved and changed, and it is now replaced by this 2021 version. In the future, ISNPCHD will again publish updated versions of IPCCC, as IPCCC continues to evolve.
ABSTRACT IMPACT: The successful conversion of an in-person biomedical research commercialization education course to a fully virtual and flipped experience (self-paced) allows greater participation from faculty investigators at CTSA institutions and serves as a model for similar educational programs intended to accelerate the translation of biomedical innovations to products of impact. OBJECTIVES/GOALS: Due to COVID-19, University of Michigan’s Fast Forward Medical Innovation developed new educational resources and leveraged virtual learning tools to convert a successful in-person research commercialization course to a fully virtual, flipped format and evaluated the effectiveness of the converted course compared to the in-person equivalent. METHODS/STUDY POPULATION: Two novel interactive modules (intellectual property and FDA regulation) and five instructional videos (customer discovery, value proposition, opportunity sizing, target product profile, and patent searches) were developed while Constant Contact and Zoom were used for a weekly progression of content delivery and to flip the course: (1) forming/testing value propositions, (2) intellectual property, (3) regulatory, (4) medical reimbursement, (5) business case development. A total of 32 faculty and graduate students completed the virtual, flipped course and submitted a post-course evaluation. Results of the converted course were compared to evaluation results from the in-person course. RESULTS/ANTICIPATED RESULTS: Open rates for the weekly email content were: (1)61%, (2)67%, (3)65%, (4)67%, and (5)59 %. Total views for the modules and videos were: IP-28, regulation-19, customer discovery-62, value proposition-21, opportunity sizing-66, target product profile-11, and patent searches-29. Evaluation results from the virtual course (n=22) were compared to mean results from the 5 previous in-person courses (n=42); 86% of virtual course respondents stated the course met the objectives compared to 85% of in-person respondents; 87% of virtual respondents stated the course met their expectations compared to 100% of in-person; 87% of virtual respondents said they would participate in a follow-up program compared to 94% in-person; 91% of virtual respondents would recommend the course to others compared to 97% of in-person. DISCUSSION/SIGNIFICANCE OF FINDINGS: Email open rates and content views suggest positive flipped participation. Overall, the converted course was comparable to the in-person course at meeting objectives, suggesting the virtual format is effective at delivering the course content and holds the potential for engaging a broader audience.
To develop an international template to support patient submissions in Health Technology Assessments (HTAs). This was to be based on the experience and feedback from the implementation and use of the Scottish Medicines Consortium's (SMC) Summary Information for Patient Groups (SIP).
To gather feedback on the SMC experience, web-based surveys were conducted with pharmaceutical companies and patient groups familiar with the SMC SIP. Semistructured interviews with representatives from HTA bodies were undertaken, along with patient group discussions with those less familiar with the SIP, to explore issues around the approach. These qualitative data informed the development of an international SIP template.
Survey data indicated that 82 percent (18 of 22 respondents) of pharmaceutical company representatives felt that the SIP was worthwhile; 88 percent (15/17) of patient group respondents found the SIP helpful. Both groups highlighted the need for additional support and guidance around plain language summaries. Further suggestions included provision of a glossary of terms and cost-effectiveness information. Patient group interviews supported the survey findings and led to the development of a new template. HTA bodies raised potential challenges around buy-in, timing, and bias connected to the SIP approach.
The international SIP template is another approach to support deliberative processes in HTA. Although challenges remain around writing summaries for lay audiences, along with feasibility considerations for HTA bodies, the SIP approach should support more meaningful patient involvement in HTAs.
Post-diagnostic psychosocial interventions could play an important role in supporting people with mild dementia remain independent. The Promoting Independence in Dementia (PRIDE) intervention was developed to address this.
The mixed methods non-randomized, pre-post feasibility study occurred across England. Facilitators were recruited from the voluntary sector and memory services. Participants and their supporters took part in the three-session intervention. Outcome measures were collected at baseline and follow-up. To evaluate acceptability, focus groups and interviews were conducted with a subsample of participants and facilitators.
Contextual challenges to delivery including national research governance changes, affected recruitment of study sites. Thirty-four dyads consented, with 14 facilitators providing the intervention. Dyads took part in at least two sessions (79%), and 73% in all three. Outcome measures were completed by 79% without difficulty, with minimal missing data. No significant changes were found on pre and post assessments. Post hoc analysis found moderate effect size improvements for self-management (SMAS instrument) in people with dementia (d = 0.41) and quality of life (EQ5D measure) in carers (d = 0.40). Qualitative data indicated that dyads found PRIDE acceptable, as did intervention facilitators.
The three-session intervention was well accepted by participant-dyads and intervention facilitators. A randomized controlled trial of PRIDE would need to carefully consider recruitment potential across geographically varied settings and site stratification according to knowledge of contextual factors, such as the diversity of post-diagnostic services across the country. Letting sites themselves be responsible for identifying suitable intervention facilitators was successful. The self-report measures showed potential to be included in the main trial.
The concentration of radiocarbon (14C) differs between ocean and atmosphere. Radiocarbon determinations from samples which obtained their 14C in the marine environment therefore need a marine-specific calibration curve and cannot be calibrated directly against the atmospheric-based IntCal20 curve. This paper presents Marine20, an update to the internationally agreed marine radiocarbon age calibration curve that provides a non-polar global-average marine record of radiocarbon from 0–55 cal kBP and serves as a baseline for regional oceanic variation. Marine20 is intended for calibration of marine radiocarbon samples from non-polar regions; it is not suitable for calibration in polar regions where variability in sea ice extent, ocean upwelling and air-sea gas exchange may have caused larger changes to concentrations of marine radiocarbon. The Marine20 curve is based upon 500 simulations with an ocean/atmosphere/biosphere box-model of the global carbon cycle that has been forced by posterior realizations of our Northern Hemispheric atmospheric IntCal20 14C curve and reconstructed changes in CO2 obtained from ice core data. These forcings enable us to incorporate carbon cycle dynamics and temporal changes in the atmospheric 14C level. The box-model simulations of the global-average marine radiocarbon reservoir age are similar to those of a more complex three-dimensional ocean general circulation model. However, simplicity and speed of the box model allow us to use a Monte Carlo approach to rigorously propagate the uncertainty in both the historic concentration of atmospheric 14C and other key parameters of the carbon cycle through to our final Marine20 calibration curve. This robust propagation of uncertainty is fundamental to providing reliable precision for the radiocarbon age calibration of marine based samples. We make a first step towards deconvolving the contributions of different processes to the total uncertainty; discuss the main differences of Marine20 from the previous age calibration curve Marine13; and identify the limitations of our approach together with key areas for further work. The updated values for ΔR, the regional marine radiocarbon reservoir age corrections required to calibrate against Marine20, can be found at the data base http://calib.org/marine/.
Bòbila Madurell-Can Gambús is the most emblematic Neolithic cemetery in the northeastern Iberian peninsula, with a total of 179 documented pit burials. Artifacts made of exogenous raw materials, such as honey flint (southeastern France), jadeite, amphibolite, eclogite and nephrite (Alps and the Pyrenees), variscite (coast of northeastern Iberia), and even obsidian (Sardinia), have been found in the burials. The presence of these raw materials is not exclusive to this necropolis, but they have also been documented in many of the graves of this region during this period. The literature has singled out this funerary practice as the Pit Burials cultural horizon. However, until now the chronology of this funerary practice has not been fully defined, so it was difficult to explain the development of the chronology and the networks through which the materials reached northeast Iberia. New, unpublished radiocarbon (14C) dates of Bòbila Madurell-Can Gambús are presented, as well as the results of different statistical analyses and Bayesian modeling that specify its chronology. Through the contribution of new data on the chronology of Bòbila Madurell-Can Gambús new clues regarding the temporal dynamics of pit burials and the raw materials exchange networks associated with them are presented.
Access to social support contributes to feelings of independence and better social health. This qualitative study aims to investigate multi-informant perspectives on informal social support in dementia care networks.
Ten spousal caregivers of people with dementia (PwD) completed an ecogram, a social network card and a semi-structured interview. The ecogram aimed to trigger subjective experiences regarding social support. Subsequently, 17 network members were interviewed. The qualitative analyses identified codes, categories, and themes.
Sixth themes emerged: (1) barriers to ask for support; (2) facilitators to ask for support; (3) barriers to offer support; (4) facilitators to offer support; (5) a mismatch between supply and demand of social support; and (6) openness in communication to repair the imbalance.
Integrating social network perspectives resulted in a novel model identifying a mismatch between the supply and demand of social support, strengthened by a cognitive bias: caregivers reported to think for other social network members and vice versa. Openness in communication in formal and informal care systems might repair this mismatch.
Family caregivers of people living with dementia can have both positive and negative experiences of caregiving. Despite this, existing outcome measures predominately focus on negative aspects of caregiving such as burden and depression. This review aimed to evaluate the development and psychometric properties of existing positive psychology measures for family caregivers of people living with dementia to determine their potential utility in research and practice.
A systematic review of positive psychology outcome measures for family caregivers of people with dementia was conducted. The databases searched were as follows: PsychINFO, CINAHL, MEDLINE, EMBASE, and PubMed. Scale development papers were subject to a quality assessment to appraise psychometric properties.
Twelve positive outcome measures and six validation papers of these scales were identified. The emerging constructs of self-efficacy, spirituality, resilience, rewards, gain, and meaning are in line with positive psychology theory.
There are some robust positive measures in existence for family caregivers of people living with dementia. However, lack of reporting of the psychometric properties hindered the quality assessment of some outcome measures identified in this review. Future research should aim to include positive outcome measures in interventional research to facilitate a greater understanding of the positive aspects of caregiving and how these contribute to well-being.
Entre los años 2007 y 2010 se desarrollaron reconocimientos pedestres acompañados de sondeos y pequeñas excavaciones en el Archipiélago de Las Perlas, Panamá. Las investigaciones más intensivas se realizaron en Isla Pedro González. Esta breve síntesis preliminar de la cronología de la ocupación prehispánica de esta isla se basa en dataciones radiocarbónicas. También incluye comparaciones tipológicas y cronométricas con dos regiones culturales: Gran Coclé hacia el Oeste, donde floreció una tradición de policromía particular entre 2500 y 450 cal a.P. y el área que se constituyó como la región cultural de Gran Darién a partir de 1200–800 cal a.P. El yacimiento más antiguo en Pedro González es precerámico (6200–5600 cal a.P.). Después de un largo hiato, esta isla fue colonizada por grupos alfareros para el 2350 cal a.P. Se plantea la existencia de cinco fases cerámicas basadas en los rangos a 2σ de las dataciones radiocarbónicas, las que se traslapan entre sí. Entre 2350 y 1450 a.P. la alfarería isleña refleja la trayectoria diacrónica de la cerámica en Gran Coclé con características propias que se extienden a zonas de tierra firme hacia el Norte, así como a islas cercanas a la costa como Taboguilla. Sin embargo, entre 1450 y 1200 cal a.P., las similitudes tipológicas con la Península de Azuero, Coclé y Playa Venado (en la costa Sur del área canalera) son tan marcadas que se asume que este área comprendió brevemente una misma zona de interacción cuya homogeneidad cultural pudo estar vinculada al comercio marítimo estimulado por la importancia de las conchas de arrecife, como Spondylus. La alfarería cambia abruptamente entre 1200 y 800 cal a.P., aludiendo a una nueva población o a un reajuste en las conexiones con tierra firme con un énfasis en el litoral Este de la Bahía de Panamá y el noroeste de Colombia.
Behavioral and psychological symptoms in dementia (BPSD) are important predictors of institutionalization as well as caregiver burden and depression. Previous reviews have tended to group BPSD as one category with little focus on the role of the individual symptoms. This review investigates the role of the individual symptoms of BPSD in relation to the impact on different measures of family caregiver well-being.
Systematic review and meta-analysis of papers published in English between 1980 and December 2015 reporting which BPSD affect caregiver well-being. Paper quality was appraised using the Downs and Black Checklist (1998).
Forty medium and high quality quantitative papers met the inclusion criteria, 16 were suitable to be included in a meta-analysis of mean distress scores. Depressive behaviors were the most distressing for caregivers followed by agitation/aggression and apathy. Euphoria was the least distressing. Correlation coefficients between mean total behavior scores and mean distress scores were pooled for four studies. Irritability, aberrant motor behavior and delusions were the most strongly correlated to distress, disinhibition was the least correlated.
The evidence is not conclusive as to whether some BPSD impact caregiver well-being more than others. Studies which validly examined BPSD individually were limited, and the included studies used numerous measures of BPSD and numerous measures of caregiver well-being. Future research may benefit from a consistent measure of BPSD, examining BPSD individually, and by examining the causal mechanisms by which BPSD impact well-being by including caregiver variables so that interventions can be designed to target BPSD more effectively.
Tailored psychosocial interventions can help families to manage
behavioural and psychological symptoms in dementia (BPSD), but carer
responses to their relative's behaviours contribute to the success of
To understand why some family carers have difficulty in dealing with
BPSD, in order to improve the quality of personalised care that is
A systematic review and meta-ethnographic synthesis was conducted of
high-quality quantitative and qualitative studies between 1980 and
We identified 25 high-quality studies and two main reasons for behaviours
being reported as challenging by family carers: changes in communication
and relationships, resulting in ‘feeling bereft’; and perceptions of
transgressions against social norms associated with ‘misunderstandings
about behaviour’ in the relative with dementia. The underlying belief
that their relative had lost, or would inevitably lose, their identity to
dementia was a fundamental reason why family carers experienced behaviour
Family carers' perceptions of BPSD as challenging are associated with a
sense of a declining relationship, transgressions against social norms
and underlying beliefs that people with dementia inevitably lose their
‘personhood’. Interventions for the management of challenging behaviour
in family settings should acknowledge unmet psychological need in family
Homocysteine-lowering nutrients may have preventive/ameliorative roles in
To test whether long-term B-vitamin/folate supplementation reduces
Participants were 4331 women (mean age 63.6 years), without prior
depression, from the Women's Antioxidant and Folic Acid Cardiovascular
Study – a randomised controlled trial of cardiovascular disease
prevention among 5442 women. Participants were randomly assigned to
receive a combination of folic acid (2.5mg/d), vitamin B6
(50mg/d) and vitamin B12 (1 mg/d) or a matching placebo.
Average treatment duration was 7 years. The outcome was incident
depression, defined as self-reported physician/clinician-diagnosed
depression or clinically significant depressive symptoms.
There were 524 incident cases. There was no difference between active
v. placebo groups in depression risk (adjusted
relative risk 1.02, 95% CI 0.86–1.21, P = 0.81), despite
significant homocysteine level reduction.
Long-term, high-dose, daily supplementation with folic acid and vitamins
B6 and B12 did not reduce overall depression
risk in mid-life and older women.
Data on the uptake of clinical guidelines into practice are essential to guide and evaluate quality improvement interventions. Organizations responsible for service specification, monitoring and improvement need to consider the practicality of and trade-offs made in different data collection methods. We examined the feasibility of deriving and applying review criteria for clinical guidelines in English primary care.
We selected two sets of guidance, on osteoporosis and depression, and used a consensus process to derive review criteria. We manually extracted data on adherence to review criteria from patient records in 20 general practices from three NHS primary care trusts in northern England. We compared the relative utility of extracted data with that of routinely available data, summarizing feasibility using what we termed a Resource Ratio.
Of 53 proposed review criteria we assessed, 41 were judged clinically important, valid, relevant and measurable. Thirty-one could be assessed in 10% or more of sampled patients, whereas 15 could be readily extracted (resource ratio of 15 or less). Only eight met all desirable attributes for use as review criteria. Resource ratios correlated poorly with local stakeholders’ prior views on feasibility of data collection. We observed wide variations in compliance with review criteria, with notably low levels among self-care standards.
A minority of guideline recommendations were suitable for review criteria development, fewer still when using routinely available data. Local stakeholders tend to underestimate the actual resource requirements of data collection. Although improved design and use of clinical records may facilitate measurement of adherence to recommended practice, detailed assessments are still likely to rely upon some degree of manual data collection in the foreseeable future.
No religious Test shall ever be required as a Qualification to any Office or public Trust under the United States.
(U.S. Constitution, Article 5)
Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof.
(U.S. Constitution, First Amendment)
This chapter begins with a short note about the author’s context and approach to the topic. Unlike the social-scientific approach of many of my colleagues’ chapters in this volume, I write from the perspective of a military ethicist who has had the privilege of working closely with U.S. military officers at the United States Air Force Academy, the Army War College, and now the Naval War College. The perspective I bring to bear on the role of religion in the military is more normative than descriptive. Because the foundation of professional military ethics in the United States is the oath each member takes to the Constitution of the United States, the question of the proper role of religious belief, practice, proselytizing, and so on, is necessarily framed in terms of how individuals understand constitutional guidance on such matters and, more important, how they ought to understand that guidance.
As the following discussion shows, these questions of constitutional understanding are by no means fixed and clear. Indeed, they are highly controversial topics among military members in the United States and in U.S. society and government itself. To some degree, this is inevitable, because the tension between the two guarantees of the First Amendment of the U.S. Constitution, the right to free exercise of one’s own religion and the restriction on the federal government’s endorsement of any particular religious belief or practice, virtually enshrines struggle about religion into the foundation of the U.S. government. This chapter explores these tensions as they have played out in the experience and practice of the U.S. military in recent years. Because the author’s professional location entails leading officers to explore and understand the proper normative behavioral standard that should guide their professional behavior in these areas of religious practice, this chapter necessarily reflects that quest for normative clarity and the importance of correcting faulty understandings and behaviors in the U.S. military.
Zircons from a bentonite near the base of the Purley Shale Formation in the Nuneaton area, Warwickshire, yield a 206Pb/238U age of 517.22 ± 0.31 Ma. Based on the fauna of small shelly fossils and the brachiopod Micromitra phillipsii in the underlying Home Farm Member of the Hartshill Sandstone Formation, trilobite fragments that are questionably referred to Callavia from the basal Purley Shale Formation, and the presence of trilobites diagnostic of the sabulosa Biozone 66 m above the base of the Purley Shale Formation, the bentonite likely dates an horizon within Cambrian Stage 3, at about the level of the Fallotaspis or basal Callavia Biozone. This is consistent with bentonite ages from other localities in southern Britain, which constrain the age of the lower and uppermost parts of Cambrian Stage 3. The new date provides additional chronological control on the earliest occurrence of trilobites in the Midland Microcraton, a date for the marine transgression at the base of the Purley Shale Formation, and is the first radiometric age from the Cambrian succession of Warwickshire.
Depression is a common and costly comorbidity in dementia. There are very few data on the cost-effectiveness of antidepressants for depression in dementia and their effects on carer outcomes.
To evaluate the cost-effectiveness of sertraline and mirtazapine compared with placebo for depression in dementia.
A pragmatic, multicentre, randomised placebo-controlled trial with a parallel cost-effectiveness analysis (trial registration: ISRCTN88882979 and EudraCT 2006-000105-38). The primary cost-effectiveness analysis compared differences in treatment costs for patients receiving sertraline, mirtazapine or placebo with differences in effectiveness measured by the primary outcome, total Cornell Scale for Depression in Dementia (CSDD) score, over two time periods: 0–13 weeks and 0–39 weeks. The secondary evaluation was a cost-utility analysis using quality-adjusted life years (QALYs) computed from the Euro-Qual (EQ-5D) and societal weights over those same periods.
There were 339 participants randomised and 326 with costs data (111 placebo, 107 sertraline, 108 mirtazapine). For the primary outcome, decrease in depression, mirtazapine and sertraline were not cost-effective compared with placebo. However, examining secondary outcomes, the time spent by unpaid carers caring for participants in the mirtazapine group was almost half that for patients receiving placebo (6.74 v. 12.27 hours per week) or sertraline (6.74 v. 12.32 hours per week). Informal care costs over 39 weeks were £1510 and £1522 less for the mirtazapine group compared with placebo and sertraline respectively.
In terms of reducing depression, mirtazapine and sertraline were not cost-effective for treating depression in dementia. However, mirtazapine does appear likely to have been cost-effective if costing includes the impact on unpaid carers and with quality of life included in the outcome. Unpaid (family) carer costs were lower with mirtazapine than sertraline or placebo. This may have been mediated via the putative ability of mirtazapine to ameliorate sleep disturbances and anxiety. Given the priority and the potential value of supporting family carers of people with dementia, further research is warranted to investigate the potential of mirtazapine to help with behavioural and psychological symptoms in dementia and in supporting carers.