Defining the decision problem: a scoping review of economic evaluations for Clostridioides difficile interventions.

BACKGROUND: Clostridioides difficile infection is the leading cause of healthcare-associated infectious diarrhoea. Several preventative and treatment interventions exist; however, decisions for their use are typically made independent of other interventions along the care pathway. AIM: To assess how the scope of the decision problem is defined in economic evaluations of C. difficile interventions. METHODS: A scoping review was conducted following the Joanna Briggs Institute framework using a comprehensive literature search with C. difficile and economic evaluation as key search concepts. Study selection and extraction were performed independently by two reviewers. An in-depth analysis of all cost-utility and cost-effectiveness analyses was conducted. Care pathway domains (i.e. infection prevention and control, antimicrobial stewardship programmes, prevention, diagnostics, treatment) were defined iteratively, and each study was classified according to the scope of the decision problem: (i) one intervention, one domain; (ii) one intervention, multiple domains; (iii) multiple interventions, one domain; and (iv) multiple interventions, multiple domains. RESULTS: In total, 3886 studies were identified. Of these, 116 studies were included in the descriptive overview, and 46 were included in the in-depth analysis. Most studies limited the scope of the decision problem to one intervention (43/46; 93%). Only three studies (3/46; 7%) assessed multiple interventions - either as bundled vs standalone interventions for prevention (i.e. a single domain), or as sequences of treatments for initial and recurrent infection (i.e. multiple domains). No study assessed multiple interventions across prevention and treatment domains. CONCLUSIONS: Economic evaluations for C. difficile infection assess narrowly defined decision problems which may have implications for optimal healthcare resource allocation.

Sustainability in Dentistry: A Multifaceted Approach Needed.

This article provides an introduction to environmentally sustainable dentistry and offers perspectives on managing drivers to reduce carbon emissions and make dentistry more environmentally sustainable. A sustainable world must meet the needs of the present without compromising the ability of future generations to meet their own needs. Global commitment to sustainability and demands for a sustainable world are growing. Within dentistry, travel creates the highest carbon emissions and also contributes to human health damage. Internally, there are a number of ways to reduce impact by decreasing travel and energy use, as well as carefully considering the types of items purchased (and how they are disposed of). Larger dental organizations can influence their suppliers and industry by choosing to purchase from sustainable companies with environmentally friendly products. From an external driver perspective policy, guidance and research are essential. Governments need to reevaluate decontamination policy from an environmental perspective. Decontamination documents need revision to consider both planetary and public health. Dental organizations need to support dental teams in this area. Insurance providers and health care purchasers should review policies to influence the sustainability of dental providers. Sustainability education needs to be considered as part of the curriculum of undergraduate and postgraduate students. Guidance could also be developed for the dental industry to produce sustainable products. Research needs to be prioritized. Identifying hot spots or areas of high environmental contributions using other assessments such as life cycle analysis (LCA) would allow dentistry to identify products or practices that have a disproportionate adverse impact on the environment and might be prioritized for change. This should include an analysis of single-use instruments, chemicals, and products. Building research capacity by training students and creating virtual or physical centers for sustainability is essential. Financial support is needed for priority areas of research.

Assessment of a multimedia-based prospective method to support public deliberations on health technology design: participant survey findings and qualitative insights.

BACKGROUND: Using a combination of videos and online short stories, we conducted four face-to-face deliberative workshops in Montreal (Quebec, Canada) with members of the public who later joined additional participants in an online forum to discuss the social and ethical implications of prospective technologies. This paper presents the participants' appraisal of our intervention and provides novel qualitative insights into the use of videos and online tools in public deliberations. METHODS: We applied a mixed-method study design. A self-administered survey contained open- and close-ended items using a 5-level Likert-like scale. Absolute frequencies and proportions for the close-ended items were compiled. Qualitative data included field notes, the transcripts of the workshops and the participants' contributions to the online forum. The qualitative data were used to flesh out the survey data describing the participants' appraisal of: 1) the multimedia components of our intervention; 2) its deliberative face-to-face and online processes; and 3) its perceived effects. RESULTS: Thirty-eight participants contributed to the workshops and 57 to the online forum. A total of 46 participants filled-in the survey, for a response rate of 73 % (46/63). The videos helped 96 % of the participants to understand the fictional technologies and the online scenarios helped 98 % to reflect about the issues raised. Up to 81 % considered the arguments of the other participants to be well thought-out. Nearly all participants felt comfortable sharing their ideas in both the face-to-face (89 %) and online environments (93 %), but 88 % preferred the face-to-face workshop. As a result of the intervention, 85 % reflected more about the pros and cons of technology and 94 % learned more about the way technologies may transform society. CONCLUSIONS: This study confirms the methodological feasibility of a deliberative intervention whose originality lies in its use of videos and online scenarios. To increase deliberative depth and foster a strong engagement by all participants, face-to-face and online components need to be well integrated. Our findings suggest that online tools should be designed by considering, one the one hand, the participants' self-perceived ability to share written comments and, on the other hand, the ease with which other participants can respond to such contributions.

How does venture capital operate in medical innovation?

While health policy scholars wish to encourage the creation of technologies that bring more value to healthcare, they may not fully understand the mandate of venture capitalists and how they operate. This paper aims to clarify how venture capital operates and to illustrate its influence over the kinds of technologies that make their way into healthcare systems. The paper draws on the international innovation policy scholarship and the lessons our research team learned throughout a 5-year fieldwork conducted in Quebec (Canada). Current policies support the development of technologies that capital investors identify as valuable, and which may not align with important health needs. The level of congruence between a given health technology-based venture and the mandate of venture capital is highly variable, explaining why some types of innovation may never come into existence. While venture capitalists' mandate and worldview are extraneous to healthcare, they shape health technologies in several, tangible ways. Clinical leaders and health policy scholars could play a more active role in innovation policy. Because certain types of technology are more likely than others to help tackle the intractable problems of healthcare systems, public policies should be equipped to promote those that address the needs of a growing elderly population, support patients who are afflicted by chronic diseases and reduce health disparities.

How do medical device manufacturers' websites frame the value of health innovation? An empirical ethics analysis of five Canadian innovations.

While every health care system stakeholder would seem to be concerned with obtaining the greatest value from a given technology, there is often a disconnect in the perception of value between a technology's promoters and those responsible for the ultimate decision as to whether or not to pay for it. Adopting an empirical ethics approach, this paper examines how five Canadian medical device manufacturers, via their websites, frame the corporate "value proposition" of their innovation and seek to respond to what they consider the key expectations of their customers. Our analysis shows that the manufacturers' framing strategies combine claims that relate to valuable socio-technical goals and features such as prevention, efficiency, sense of security, real-time feedback, ease of use and flexibility, all elements that likely resonate with a large spectrum of health care system stakeholders. The websites do not describe, however, how the innovations may impact health care delivery and tend to obfuscate the decisional trade-offs these innovations represent from a health care system perspective. Such framing strategies, we argue, tend to bolster physicians' and patients' expectations and provide a large set of stakeholders with powerful rhetorical tools that may influence the health policy arena. Because these strategies are difficult to counter given the paucity of evidence and its limited use in policymaking, establishing sound collective health care priorities will require solid critiques of how certain kinds of medical devices may provide a better (i.e., more valuable) response to health care needs when compared to others.

Consent for newborn screening: the attitudes of health care providers.

BACKGROUND: As newborn screening (NBS) expands to meet a broader definition of benefit, the scope of parental consent warrants reconsideration. METHODS: We conducted a mixed methods study of health care provider attitudes toward consent for NBS, including a survey (n = 1,615) and semi-structured interviews (n = 36). RESULTS: Consent practices and attitudes varied by provider but the majority supported mandatory screening (63.4%) and only 36.6% supported some form of parental discretion. Few health care providers (18.6%) supported seeking explicit consent for screening condition-by-condition, but a larger minority (39.6%) supported seeking consent for the disclosure of incidentally generated sickle cell carrier results. Qualitative findings illuminate these preferences: respondents who favored consent emphasized its ease while dissenters saw consent as highly complex. CONCLUSION: Few providers supported explicit consent for NBS. Further, those who supported consent viewed it as a simple process. Arguably, these attitudes reflect the public health emergency NBS once was, rather than the public health service it has become. The complexity of NBS panels may have to be aligned with providers' capacity to implement screening appropriately, or providers will need sufficient resources to engage in a more nuanced approach to consent for expanded NBS.

Clinical obligations and public health programmes: healthcare provider reasoning about managing the incidental results of newborn screening.

BACKGROUND: Expanded newborn screening generates incidental results, notably carrier results. Yet newborn screening programmes typically restrict parental choice regarding receipt of this non-health serving genetic information. Healthcare providers play a key role in educating families or caring for screened infants and have strong beliefs about the management of incidental results. METHODS: To inform policy on disclosure of infant sickle cell disorder (SCD) carrier results, a mixed-methods study of healthcare providers was conducted in Ontario, Canada, to understand attitudes regarding result management using a cross-sectional survey (N = 1615) and semistructured interviews (N = 42). RESULTS: Agreement to reasons favouring disclosure of SCD carrier results was high (65.1%-92.7%) and to reasons opposing disclosure was low (4.1%-18.1%). Genetics professionals expressed less support for arguments favouring disclosure (35.3%-78.8%), and more agreement with arguments opposing disclosure (15.7%-51.9%). A slim majority of genetics professionals (51.9%) agreed that a reason to avoid disclosure was the importance of allowing the child to decide to receive results. Qualitatively, there was a perceived "duty" to disclose, that if the clinician possessed the information, the clinician could not withhold it. DISCUSSION: While a majority of respondents perceived a duty to disclose the incidental results of newborn screening, the policy implications of these attitudes are not obvious. In particular, policy must balance descriptive ethics (ie, what providers believe) and normative ethics (ie, what duty-based principles oblige), address dissenting opinion and consider the relevance of moral principles grounded in clinical obligations for public health initiatives.

'Hypersynchronisation' by tissue velocity imaging in patients with cardiac amyloidosis.

OBJECTIVE: It is unknown if some patients with cardiac amyloidosis (CA) have mechanical dyssynchrony, as has been demonstrated in patients with ischaemic and dilated cardiomyopathies. The aim of this study was to assess mechanical dyssynchrony in patients with CA using tissue velocity imaging (TVI) and to define its usefulness for risk stratification. DESIGN AND PATIENTS: We included 121 patients with primary amyloidosis and 37 age-matched and sex-matched controls. Patients were divided into two groups: 60 with advanced-CA and 61 with no-advanced-CA, according to left ventricular (LV) wall thickness and diastolic dysfunction. Dyssynchrony assessment included: (1) atrioventricular dyssynchrony (dys), (2) interventricular dys, (3) intraventricular dys assessed longitudinally, using the standard deviation of time to systolic peak velocity (Ts-SD) of the 12 basal and mid level LV segments, and (4) intraventricular dys assessed radially, using the difference in radial Ts between mid anteroseptal and mid posterior segments. OUTCOME: Primary end-point was all-cause death. During a median follow-up of 13 months there were 35 events among patients. RESULTS: Contrary to the hypothesis, the intraventricular dys indices in advanced-CA patients were reduced compared to either the no-advanced-CA group or to controls (Ts-SD: 12.1 (9.0); 35.1 (18.6); 24.5 (14.1), respectively, p<0.001). This reduction was primarily the result of decreased ejection time (ET). Moreover, ET was the most significant predictor of survival (HR = 0.98, p<0.001). CONCLUSIONS: The regional timing of systolic motion measured by TVI was abnormally synchronised in the patients with advanced-CA. ET reduction plays a prominent part in this process and should be considered an essential parameter for assessment of patients with cardiac amyloidosis.

A systematic review of the effects of disclosing carrier results generated through newborn screening.

Evidence on the effects of disclosing carrier results identified through newborn screening (NBS) is needed to develop effective strategies for managing these results, and to inform debate about contradictory policies governing genetic testing in minors in the context of NBS relative to clinical care. This is likely to be even more important as technological opportunities for carrier identification through NBS increase. We report the results of a systematic review of evidence related to the generation of carrier results through NBS to summarize what is known about: (1) the outcomes associated with these results; (2) the best strategies for providing information and follow-up care to parents; and (3) the impact they have on reproductive decision-making. Our study expands the existing body of knowledge and identifies gaps in the evidence base. As key players in the management of carrier results clinically, genetic counselors are well positioned to engage in formative research and policy development in this area.

Duty to disclose what? Querying the putative obligation to return research results to participants.

Many research ethics guidelines now oblige researchers to offer research participants the results of research in which they participated. This practice is intended to uphold respect for persons and ensure that participants are not treated as mere means to an end. Yet some scholars have begun to question a generalised duty to disclose research results, highlighting the potential harms arising from disclosure and questioning the ethical justification for a duty to disclose, especially with respect to individual results. In support of this view, we argue that current rationales for a duty of disclosure do not form an adequate basis for an ethical imperative. We review policy guidance and scholarly commentary regarding the duty to communicate the results of biomedical, epidemiological and genetic research to research participants and show that there is wide variation in opinion regarding what should be disclosed and under what circumstance. Moreover, we argue that there is fundamental confusion about the notion of "research results," specifically regarding three core concepts: the distinction between aggregate and individual results, amongst different types of research, and across different degrees of result veracity. Even where policy guidance and scholarly commentary have been most forceful in support of an ethical imperative to disclose research results, ambiguity regarding what is to be disclosed confounds ethical action.

Calcific retinal embolism as an indicator of severe unrecognised cardiovascular disease.

OBJECTIVE: To describe the association between calcific retinal embolism (CRE) and cardiac valve stenosis. DESIGN AND SETTING: Retrospective chart review of patients with clinical criteria for CRE. PATIENTS: 24 patients with CRE who underwent two dimensional echocardiography between 1976 and 1998. RESULTS: Nine patients (38%) had calcific valve stenosis, which was haemodynamically severe in five patients (four aortic and one mitral), four of whom had no cardiac symptoms. Six patients underwent surgical intervention (aortic valve replacement in three patients, mitral and aortic valve replacement in one patient, removal of calcific cardiac pseudotumour in one patient, and carotid endarterectomy in one patient). CONCLUSIONS: CRE may be the presenting feature of otherwise asymptomatic, clinically important underlying cardiovascular disease and, in particular, haemodynamically severe calcific valve stenosis.

Progression of familial and non-familial dilated cardiomyopathy: long term follow up.

BACKGROUND: It is unknown whether progression of familial idiopathic dilated cardiomyopathy differs from progression in the non-familial form. It has been suggested that familial disease indicates a worse prognosis, and that this should be considered when planning the timing of heart transplantation. OBJECTIVE: To compare five year survival or time to heart transplantation in an unselected series of patients with dilated cardiomyopathy who had been evaluated for familial v non-familial disease through the echocardiographic investigation of first degree relatives. DESIGN: Medical records were reviewed and questionnaires were mailed to all patients who had previously participated in a family based study of dilated cardiomyopathy. Information was gathered about survival, heart transplantation, and left ventricular ejection fraction (LVEF) measurements. Survival data were censored at the time of cardiac transplantation. RESULTS: Follow up data were obtained for 99 of 101 patients (69 with non-familial and 30 with familial disease). Five year survival was 55% for non-familial and 51% for familial patients (NS). The main predictor of mortality was an LVEF of < 30%. Familial status did not predict mortality. There was no significant difference in follow up LVEF values between the groups. CONCLUSIONS: Five year survival is not significantly different in the familial and non-familial forms of dilated cardiomyopathy.

Eustachian valve cyst.

Transesophageal echocardiography provides high resolution of intracardiac structures. One potential problem is the misdiagnosis of previously unrecognized benign cardiac structures as malignant processes, leading to unnecessary surgical procedures. We describe an unusual case of benign intracardiac eustachian valve cyst monitored over 2 years.

Patent foramen ovale transcatheter closure device thrombosis.

The role of patent foramen ovale (PFO) in patients with cryptogenic stroke (stroke of unknown cause) remains controversial, although an association seems likely in younger patients with atrial septal aneurysms and PFO. The mechanism of cryptogenic stroke in these patients is presumed to be paradoxical embolism via right-to-left shunt across the PFO. The available options for treatment include medical therapy with antiplatelet or anticoagulant therapy or closure of the PFO surgically or with use of transcatheter PFO closure devices. We describe 2 cases of bilateral device thrombosis associated with use of a transcatheter PFO closure device (CardioSEAL). To our knowledge, only 1 other case of thrombosis associated with use of this device has been reported.

Doppler hemodynamics of 51 clinically and echocardiographically normal pulmonary valve prostheses.

OBJECTIVE: To determine the normal Doppler hemodynamics of various pulmonary valve prostheses (PVPs). PATIENTS AND METHODS: We retrospectively analyzed comprehensive Doppler echocardiographic examinations of 51 patients (mean age, 27.8 years; range, 1-59 years) with PVPs that were normal on clinical and 2-dimensional echocardiographic examinations to establish the normal hemodynamics of various types and sizes of PVPs. The earliest complete postoperative transthoracic echocardiogram was identified for each patient. Doppler examinations were analyzed for peak instantaneous velocity, right ventricular outflow tract velocity, and peak and mean systolic gradient. The frequency of prosthetic regurgitation was also noted. RESULTS: The average +/- SD peak instantaneous velocity for all PVPs was 2.24+/-0.6 m/s, with an average peak systolic gradient of 20.4+/-10.4 mm Hg and an average mean systolic gradient of 11.0+/-5.1 mm Hg. The mean right ventricular outflow tract velocity was 1.0+/-0.2 m/s. Pulmonary homografts were found to have significantly lower peak velocities (average, 1.8+/-0.6 m/s) than all heterografts combined (average, 2.4+/-0.5 m/s; P=.002). Prosthetic regurgitation was more common in pulmonary homografts (88%) than in heterografts combined (29%; P<.001). CONCLUSION: This study establishes the normal range for Doppler hemodynamics of various PVPs, specifically homografts and heterografts, in both pediatric and adult patients.

Reoperation for prosthetic aortic valve obstruction in the era of echocardiography: trends in diagnostic testing and comparison with surgical findings.

OBJECTIVES: We sought to: 1) identify trends in the diagnostic testing of patients with prosthetic aortic valve (AVR) obstruction who undergo reoperation and 2) compare diagnostic test results with pathologic findings at surgery. BACKGROUND: It is unclear whether Doppler transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE) have reduced hemodynamic catheterization rates. METHODS: We reviewed 92 consecutive cases ofAVR reoperation at a single center from 1989 to 1998, comparing 49 cases of mechanical AVR obstruction (group A) to 43 cases of bioprosthetic obstruction (group B). Preoperative Doppler TTE was performed in all cases. RESULTS: In group A cases, there was a marginally significant trend towards lower catheterization rates for the Gorlin AVR area, from 36% in 1989 to 1990 to 10% in 1997 to 1998 (p = 0.07), but diagnostic TEE utilization (47% of cases) did not vary. The cause of mechanical AVR obstruction was pannus in 26 cases (53%), mismatch (P-PM) in 19 (39%) and thrombosis in 4 (8%). The mechanism (pannus/thrombus vs. mismatch) was identified in 10% by TTE and 49% by TEE (p < 0.001). In group B cases, hemodynamic catheterization rates (21%) and diagnostic TEE utilization (21%) did not vary with time. Obstruction was caused by structural degeneration in 37 cases (86%), thrombosis in 3 (7%), mismatch in 2 (5%) and pannus in 1 (2%). The mechanism was correctly identified in 63% by TTE and in 81% by TEE (p = 0.18). CONCLUSIONS: Doppler TTE is the primary means to diagnose AVR obstruction; hemodynamic catheterization is not routinely needed. In unselected patients with mechanical AVR obstruction, TEE differentiation of pannus or thrombus from mismatch is challenging.

Outcome of reoperation for aortic valve prosthesis-patient mismatch.

We report a single center's 10-year experience with 21 consecutive cases of repeat aortic valve replacement for prosthesis-patient mismatch (P-PM) in which there was no hospital mortality among 12 patients treated for isolated P-PM. With an overall survival of 92% at a median follow-up of 4.5 years and functional class I symptoms in most survivors (73%), we conclude that repeat surgery for isolated P-PM has a relatively low mortality and a good intermediate-term clinical outcome.

Clinical utility of Doppler echocardiography and tissue Doppler imaging in the estimation of left ventricular filling pressures: A comparative simultaneous Doppler-catheterization study.

BACKGROUND: Noninvasive assessment of diastolic filling by Doppler echocardiography provides important information about left ventricular (LV) status in selected subsets of patients. This study was designed to assess whether mitral annular velocities as assessed by tissue Doppler imaging are associated with invasive measures of diastolic LV performance and whether additional information is gained over traditional Doppler variables. METHODS AND RESULTS: One hundred consecutive patients referred for cardiac catheterization underwent simultaneous Doppler interrogation. Invasive measurements of LV pressures were obtained with micromanometer-tipped catheters, and the mean LV diastolic pressure (M-LVDP) was used as a surrogate for mean left atrial pressure. Doppler signals from the mitral inflow, pulmonary venous inflow, and TDI of the mitral annulus were obtained. Isolated parameters of transmitral flow correlated with M-LVDP only when ejection fraction <50%. The ratio of mitral velocity to early diastolic velocity of the mitral annulus (E/E') showed a better correlation with M-LVDP than did other Doppler variables for all levels of systolic function. E/E' <8 accurately predicted normal M-LVDP, and E/E' >15 identified increased M-LVDP. Wide variability was present in those with E/E' of 8 to 15. A subset of those patients with E/E' 8 to 15 could be further defined by use of other Doppler data. CONCLUSIONS: The combination of tissue Doppler imaging of the mitral annulus and mitral inflow velocity curves provides better estimates of LV filling pressures than other methods (pulmonary vein, preload reduction). However, accurate prediction of filling pressures for an individual patient requires a stepwise approach incorporating all available data.