Direct Individual Benefit Research Articles

Potential Impact of Nirsevimab on RSV Transmission and Medically Attended Lower Respiratory Tract Illness Caused by RSV: A Disease Transmission Model.

IntroductionRespiratory syncytial virus (RSV) is associated with significant morbidity worldwide, especially among infants. We evaluated the potential impact of prophylactic nirsevimab, a monoclonal antibody, in infants experiencing their first RSV season, and the number of medically-attended lower respiratory tract infection episodes caused by RSV (RSV-MALRTI) in the USA.MethodsWe developed an age-structured, dynamic, deterministic compartmental model reflecting RSV natural history, incorporating USA demographic data and an age-specific contact matrix. We assumed either no effect of nirsevimab on transmission (scenario 1) or a 50% reduction of viral shedding (scenario 2). Model outcomes were RSV-MALRTIs, ICD-9 coded in the Marketscan® database by month. We focused on age groups corresponding to the first 2 years of life, during seven RSV seasons (2008–2015).ResultsScenario 1 illustrated the direct individual benefit when a universal immunization strategy is applied to all infants. In scenario 2, herd protection was observed across age groups, with 15.5% of all avoided cases due to reduced transmission; the greatest impact was in the youngest age group and a benefit was observed in those aged 65+ years.ConclusionThese preliminary data suggest that single-dose nirsevimab will benefit infants experiencing their first RSV season, with a potential increase in effectiveness dependent on nirsevimab’s mechanism of action.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40121-021-00566-9.

Employee Dilemmas From Competing Organizational Goals: Insights from Emergency Medical Services

The literature on multiple-goal organizations highlights the unique challenge of simultaneously meeting potentially conflicting profit and prosocial objectives. We study individual level performance effects on the delivery of a prosocial service in the presence of strong organization-level financial incentives. We examine these effects within the context of Emergency Medical Service (EMS) crews responding to 9-1-1 calls. Using data from 31 states reported to the US National Emergency Medical Services Information System, we find that even in the absence of direct individual benefits, EMS crews are responsive to the financial sustainability objective of their agencies by providing higher levels of service to patients with higher ability to pay. Specifically, we find that both private insurance and Medicare patients receive more procedures (4.6% and 1.5%) and have longer transport times (5.1% and 3.9%) than Medicaid patients controlling for time, call, patient, and condition characteristics. These differences reduce with call urgency and for agencies with a higher proportion of high ability to pay patients in the recent past but increase on busy days. The robustness of our findings derives from the quasi-random assignment of insurance across EMS units’ runs and the fixed effects specification in our models and is supported by several robustness checks including instrumental variable analyses.

Concerns for others increase the likelihood of vaccination against influenza and COVID-19 more in sparsely rather than densely populated areas

Vaccination yields the direct individual benefit of protecting recipients from infectious diseases and also the indirect social benefit of reducing the transmission of infections to others, often referred to as herd immunity This research examines how prosocial concern for vaccination, defined as people's preoccupation with infecting others if they do not vaccinate themselves, motivates vaccination in more and less populated regions of the United States. A nationally representative, longitudinal survey of 2,490 Americans showed that prosocial concern had a larger positive influence on vaccination against influenza in sparser regions, as judged by a region's nonmetropolitan status, lesser population density, and lower proportion of urban land area. Two experiments (total n = 800), one preregistered, provide causal evidence that drawing attention to prosocial (vs. individual) concerns interacted with social density to affect vaccination intentions. Specifically, prosocial concern led to stronger intentions to vaccinate against influenza and COVID-19 but only when social density was low (vs. high). Moderated mediation analyses show that, in low-density conditions, the benefits of inducing prosocial concern were due to greater perceived impact of one's vaccination on others. In this light, public health communications may reap more benefits from emphasizing the prosocial aspects of vaccination in sparser environments.

Explaining public risk acceptance of a petrochemical complex: A delicate balance of costs, benefits, and trust

Communities adjacent to polluting industrial facilities understand and evaluate risk in often ambivalent and contextualized ways, not only balancing economic and environmental concerns but also reflecting cultural practices, social worldviews, and trust relationships. In this case study of the Antwerp petrochemical complex, the largest in Europe, a residents’ survey and interviews are used to examine how two middle-class communities coexist with the nearby petrochemical plants. The findings show that citizens in both communities are generally aware of the environmental impact and public health risk but are predominantly accepting of the industry. For both communities, the most important factor explaining acceptance is the perceived socio-economic benefit for the community, while a direct individual benefit in terms of employment does not play a significant role. In one community, risk acceptance is further strengthened by trust in companies’ risk management, while in the other community, trust in regulators is more critical. The different results for both communities stress the importance of a socio-cultural perspective on risk and underline the criticality of relationships of trust. The article further discusses the implications of these findings for environmental decision-making, considering the delicate balance and the significant minority of the population who is less accepting. The present study adds to the risk perception literature by providing one of the first quantitative analyses explaining industrial risk acceptance, instead of perception, using the increasingly contested petrochemical industry as an exemplary case.

Key mechanisms by which post-ICU activities can improve in-ICU care: results of the international THRIVE collaboratives

ObjectiveTo identify the key mechanisms that clinicians perceive improve care in the intensive care unit (ICU), as a result of their involvement in post-ICU programs.MethodsQualitative inquiry via focus groups and interviews with members of the Society of Critical Care Medicine’s THRIVE collaborative sites (follow-up clinics and peer support). Framework analysis was used to synthesize and interpret the data.ResultsFive key mechanisms were identified as drivers of improvement back into the ICU: (1) identifying otherwise unseen targets for ICU quality improvement or education programs—new ideas for quality improvement were generated and greater attention paid to detail in clinical care. (2) Creating a new role for survivors in the ICU—former patients and family members adopted an advocacy or peer volunteer role. (3) Inviting critical care providers to the post-ICU program to educate, sensitize, and motivate them—clinician peers and trainees were invited to attend as a helpful learning strategy to gain insights into post-ICU care requirements. (4) Changing clinician’s own understanding of patient experience—there appeared to be a direct individual benefit from working in post-ICU programs. (5) Improving morale and meaningfulness of ICU work—this was achieved by closing the feedback loop to ICU clinicians regarding patient and family outcomes.ConclusionsThe follow-up of patients and families in post-ICU care settings is perceived to improve care within the ICU via five key mechanisms. Further research is required in this novel area.

Key Mechanisms by Which Post-ICU Activities Can Improve In-ICU Care: Results of the International Thrive Collaborative

Objective: Identify the key mechanisms which clinicians perceive improve care in the intensive care unit (ICU), as a result of their involvement in post ICU programs. Methods: Qualitative inquiry via focus groups and interviews with members of the Society of Critical Care Medicine's Thrive collaboratives from over 20 centres in the UK, Australia and US (follow-up clinics and peer support). Framework Analysis was used to synthesize and interpret the data. Results: Five key mechanisms were identified as drivers of improvement back into the ICU: 1) Identifying otherwise unseen targets for ICU quality improvement or education programs - new ideas for quality improvement were generated and greater attention paid to detail in clinical care. 2) Creating a new role for survivors in the ICU - former patients and family members adopted an advocacy or peer volunteer role. 3) Inviting critical care providers to the post-ICU program to educate, sensitize, and motivate them - clinician peers and trainees were invited to attend as a helpful learning strategy to gain insights into post-ICU care requirements. 4) Changing clinician's own understanding of patient experience - there appeared to be a direct individual benefit from working in post-ICU programs. 5) Improving morale and meaningfulness of ICU work - this was achieved by closing the feedback loop to ICU clinicians regarding patient and family outcomes. Conclusions: The follow-up of patients and families in post-ICU care settings is perceived to improve care within the ICU via five key mechanisms. Further testing of whether these mechanisms drive improvements in patient and family-centered care, and whether these programs enhance clinician well-being and ICU culture, is warranted. Funding Statement: K Haines, J McPeake, L Boehm, C Sevin and Tara Quasim are currently receiving funding from SCCM to undertake this work. L Boehm is funded by NIH/NHLBI (K12 HL137943) as is T J Iwashyna (K12 HL138039). Declaration of Interests: : K Haines, J McPeake, L Boehm, C Sevin and Tara Quasim are currently receiving funding from SCCM to undertake this work. L Boehm is funded by NIH/NHLBI (K12 HL137943) as is T J Iwashyna (K12 HL138039). No conflicts of interest declared by other authors. Ethics Approval Statement: The institutional ethics committee of the principal investigator (KH) approved the study (HREC/17/WH/170) and consent was implied through participation.

A proposed selection process in Over-The-Top project portfolio management

Purpose: The purpose of this paper is to propose an Over-The-Top (OTT) initiative selection process for communication service providers (CSPs) entering an OTT business.Design/methodology/approach: To achieve this objective, a literature review was conducted to comprehend the past and current practices of the project (or initiative) selection process as mainly suggested in project portfolio management (PPM). This literature was compared with specific situations and the needs of CSPs when constructing an OTT portfolio. Based on the contrast between the conventional project selection process and specific OTT characteristics, a different selection process is developed and tested using group model-building (GMB), which involved an in-depth interview, a questionnaire and a focus group discussion (FGD).Findings: The paper recommends five distinct steps for CSPs to construct an OTT initiative portfolio: candidate list of OTT initiatives, interdependency diagram, evaluation of all interdependent OTT initiatives, evaluation of all non-interdependent OTT initiatives and optimal portfolio of OTT initiatives.Research limitations/implications: The research is empirical, and various OTT services are implemented; the conclusion is derived only from one CSP, which operates as a group. Generalization of this approach will require further empirical tests on different CSPs, OTT players or any firms performing portfolio selection with a degree of interdependency among the projects.Practical implications: Having considered interdependency, the proposed OTT initiative selection steps can be further implemented by portfolio managers for more effective OTT initiative portfolio construction.Originality/value: While the previous literature and common practices suggest ensuring the benefits (mainly financial) of individual projects, this research accords higher priority to the success of the overall OTT initiative portfolio and recommends that an evaluation of the overall portfolio should occur prior to individual evaluation. Consequently, certain initiatives may not provide direct individual benefits. Those initiatives should remain within the portfolio because they are needed for the success of other initiatives.

Projecting the effects of tobacco control policies in the USA through microsimulation: a study protocol

IntroductionSmoking remains the leading cause of preventable death in the USA but can be reduced through policy interventions. Computational models of smoking can provide estimates of the projected impact of...

Measurement of the Ability to Recognize Facial Emotions over the Adult Lifetime in a Supra-Normal Sample

Background: Measuring the ability to recognize facial emotions has been the object of a growing number of studies. However, the heterogeneity of the measuring devices used and the images tested led to partial agreements and conflicting results in the scientific literature. The lack of agreed upon computerized measuring devices worsens the situation. Description of the study and methods used: This was a single blind, randomized, controlled study of parallel groups with no direct individual benefit for the volunteers. We used Method of Research Analysis of Emotional Integration (M.A.R.I.E.), which is “software,” meaning in this case a computerized measuring device that quantifies the process of facial emotional recognition. This tool and the methodology are amply illustrated in previously published articles by the same authors and by the principal author. We have established prescriptive parameters and standards for the recognition of anger, disgust, joy, fear, surprise, sadness, and neutrality on three faces from a control group of 204 subjects between the ages of 20 and 70 years, all White Caucasians from Northern France, whose cognitive functions were at an optimum level. Hence, the subjects in the study sample were described in this article as “supra-normal.” This study was conducted between April 2000 and April 2005 in Northern France in Lille City, home town of Duchenne de Boulogne (1806-1875) famous for Duchenne-smile. The Results: The results indicated that: 1) at whatever age of the subject, a) joy is the most recognized emotion, and b) anger is the most difficult to recognize; 2) aging of the subjects alters the ability to recognize emotion on a given face; 3) the recognition of a given emotion depends on the face on which it is expressed; 4) recognition of fear and disgust persists at the same level, despite aging of the subjects; 5) the recognition of joy improves with age; 6) the identity of a face is important in the recognition of emotions; 7) level of education does not affect the ability to recognize facial emotions, and; 8) 1% of the supra-normal population with even an optimum level of cognition has difficulty recognizing facial emotional expressions. Conclusions: The inborn potential to express and recognize facial emotions (RFE) typically manifests in infancy well before the acquisition of language and cultural influences. The study tracks this ability as a unique "Developmental Line" for a homogeneous adult sample using a special measuring tool. The quantitative analysis of the findings leads to a conclusion that we need to further refine our scientific definition of what constitutes “emotion” and identify innate complex neuropsychological and neurobiological processes in which a series of determinants ranging from inborn endowments to sociocultural influences interact in still poorly understood ways. In spite of that, it can be concluded that the conventional cultural wisdom or innate drives for survival of the species may be influencing the differences found in the ability to perceive, discern and label certain canonical emotions accurately and efficiently. Also, there are some definitive trends that can be inferred to guide clinical practice. For example, joy is universally recognized, and therefore, may be more relevant for building therapeutic relationship than the emotion-neutral expression of the therapist in most face to face therapeutic settings. There are also variations in this ability in the aging subjects, changing in positive and negative directions for different emotions for their expression and recognition through the life cycle. Some trends can be definitely identified as normal variations. This study on a culturally homogeneous small sample of white Caucasian French population opens many areas for future research, for replication in various other groups, clinical diagnostic studies, and early therapeutic interventions.

Programed Death is Favored by Natural Selection in Spatial Systems.

Standard evolutionary theories of aging and mortality, implicitly based on mean-field assumptions, hold that programed mortality is untenable, as it opposes direct individual benefit. We show that in spatial models with local reproduction, programed deaths instead robustly result in long-term benefit to a lineage, by reducing local environmental resource depletion via spatiotemporal patterns causing feedback over many generations. Results are robust to model variations, implying that direct selection for shorter life span may be quite widespread in nature.

What factors influence emergency department staff attitudes towards using information technology?

ObjectivesInformation technology (IT) has an important role in the emergency department (ED) functioning, but staff attitudes can influence the way IT is used. Qualitative research into the perceptions of the...

Economic evidence of influenza vaccination in children

We review published economic evaluations of influenza vaccination for children, including direct individual benefits and indirect societal benefits, to determine whether more studies are needed to fully understand the expected benefits of such strategies. We searched MEDLINE and EMBASE databases to May 2006 and in-press articles to October 2006 for studies including economic analyses of influenza vaccination in children. Abstracts of all potentially relevant articles were screened. Fifteen relevant articles from 1983 were retained. Most were based on modelling, using previously published data and considered the societal perspective. Three were a part of prospective clinical trials. Various paediatric vaccination scenarios and parameters were considered. Vaccinating children against influenza was cost saving or cost effective in 10/15 studies, cost saving or effective only under certain conditions in three studies, and not cost saving or effective in two studies whatever the outcome or perspective considered. Most published evidence points to an economic interest for society of vaccinating children against influenza. However, differences in study design hinder the comparison of the various vaccination strategies considered. Comparable and complete data on the burden and cost of disease, and the cost of vaccination are needed, especially outside of North America.

Détection du ganglion sentinelle dans les carcinomes épidermoïdes de la cavité buccale et de l’oropharynx. Étude préliminaire

The sentinel lymph node is defined as the first relay of the lymphatic drainage of the tumor. Isotopic detection of the sentinel lymph node and absence of its metastatic invasion should theoretically be predictive of total drainage of the tumor. The goal of this study was to evaluate sentinel lymph node detectability by lymphoscintigraphy in N0 and/or N1 squamous-cell carcinoma of oral cavity and oropharynx and to determine its negative predictive value. Lymphoscintigraphy was used for sentinel lymph node detection. The procedure required peritumoral injection of technicium-labeled colloids to enable anatomical and cutaneous location of the sentinel lymph node. A one-way Tyco-Mallinckrodt probe was used for intraoperative detection of the sentinel lymph node. This prospective study included 21 patients with N0 or N1 squamous-cell carcinoma of the oral cavity and the oropharynx. The surgical attitude based on T and N was not modified in this prospective study without direct individual benefit for the patient. Neck dissection was achieved without difficulty. The sentinel lymph node was identified in 20 out of 21 subjects. The sentinel lymph node was not identified in one patient with recurrence T2N0M0 squamous-cell carcinoma of the oropharynx radiated 3 years earlier. The percentage of false-negatives was 12.5% (1 false-negative out of 8 positive patients), giving a sensibility of the detection method of 87.5% (IC (95%)=[47.35-99.68]). This false-negative patient had a T3N0M0 squamous-cell carcinoma of the oropharynx with a sentinel lymph node removed in territory III. Neck dissection revealed 1 N + R- in the sub-mandibular territory associated with 27 N-R-. The probability of not finding a metastatic node at neck dissection when the sentinel lymph node is not metastatic (negative predictive value) was 92.3% (12/13) (IC (95)=[63.97-99.81]). The specificity of the method was 100%, as was the positive predictive value, because no sentinel node was diagnosed positive wrongly on frozen sections among patients without true histological node metastasis. For routine care of patients with squamous-cell carcinoma of the oral cavity and the oropharynx detection of the sentinel lymph node is proposed primarily for patients with T1T2N0 staging. Larger tumors can modify the architecture and flow within the lymphatic ducts, and consequently even the concept of a sentinel lymph node. Systematic neck dissection is required or T3T4, even when N0. Our series of T1T2N0 tumors is too small to enable statistically significant conclusions. A low level of false-negative in a larger series would be necessary to propose this technique instead of convention neck dissection for T1T2 tumors of the oral cavity and oropharynx.

Efficacité du céfotiam hexétil en cure courte dans le traitement des sinusites maxillaires aiguës. Comparaison de l'efficacité d'un traitement de cinq vs dix jours

Objective. – The aim of this multicentric, randomized, double blind study with direct individual benefit, was to compare two therapeutic regimens of cefotiam hexetil administration, 5 days vs 10 days, in acute maxillary sinusitis. Method. – The study was conducted in ambulatory patients treated by general practitioners according to AFSAPS (French agency for sanitary safety) guidelines for treatment of acute maxillary sinusitis. Five hundred and fifty three GPs included 1042 patients presenting with acute maxillary sinusitis in the study from December 2000 to July 2001. Patients were randomly treated with cefotiam hexetil 200 mg bid over a 5 day period followed by 5 days of placebo, or with cefotiam hexetil 200 mg bid over a 10 day period. Results. – No significant difference was noted in each treatment group. Radiography performed in 72.2% of included patients confirmed the diagnosis in 78.8% of the cases. No significant difference occurred in the number and percentage of cured patients. In the ITT analysis (1018 patients) the clinical cure rates were respectively 85.5% and 85.3% in the 5 day and in the 10 day treatment groups, In the PP analysis (800 patients) the clinical cure rates were respectively 88.6% in each group. The low incidence of adverse effects (3.36%) was confirmed in both groups. Conclusion. – A 5 day course of cefotiam hexetil 200 mg bid is as effective as a 10 day course in the treatment of acute maxillary sinusitis in adults.

La recherche avec bénéfice individuel direct existe-t-elle ?

The European Commission and Parliament have promulgated a directive on clinical research (2001/20/CE) in April 2001. Its provisions have to be incorporated in all national laws by May 2004. Accordingly, the French " loi Huriet " (a law passed in 1988 organizing clinical research in France) had to be revised. During the process, it appeared that a key issue was the suppression of a distinction made by this law between research with and without " direct individual benefit ", a French specificity, as the directive recommends rather the assessment of the risk/benefit ratio. In order to harmonize the French legislation with the other European laws, and to suppress a set of provisions which have been repeatedly attacked during the last ten years, the French members of parliament have voted on October 2003 a new law which, among other important modifications, suppress that distinction.

The energetic cost of reproductive conflicts in the ant Pachycondyla obscuricornis

In a variety of social animals, individuals can secure reproductive rights through aggressive dominance. Direct individual benefits of aggression are widely recognized, but underlying costs affecting group productivity, and thus indirect benefits, are less clear. Costs of aggressive regulation of reproduction are especially important in small social insect colonies, where individual workers could potentially dominate male production. We estimated the energetic costs associated with the regulation of worker reproduction in the ponerine ant Pachycondyla obscuricornis, using the total CO 2 emission of a colony as a measure. The level of CO 2 emission of 12 experimental colonies varied significantly during five periods with varying levels of aggression and egg-laying. Overall, CO 2 emission increased with the degree of fighting in a colony, but was not associated with differences in egg-laying. Aggressive regulation of reproduction and the formation of a dominance hierarchy thus pose an energetic cost to the colony. Furthermore, workers reduce their work-activities immediately after experimental orphaning, giving a further cost to the colony. These costs might influence the outcome of conflicts over male production in ants. This paper presents the first quantification of energetic costs of aggressive behavior regulating reproduction in ants.

Sur l’encadrement législatif des recherches biomédicales chez l’homme, à l’occasion de la transposition dans le droit français de la directive européenne

The French National Academy of Medicine considers that biomedical research in humans is a necessity for Public Health. This research is indispensable to medical progress and public health. It must respect medical ethics, scientific rigor, and should be implemented within a legislative framework. The Academy is concerned by the insufficient French participation in this research, which is largely a result of the small number of patients included in therapeutic trials that are necessary to the progression of knowledge and the improvement of diagnosis and treatment. Such research should be encouraged and unjustified (or useless) constraints should be lifted, particularly those which weigh on studies whose goal is furthering knowledge and are independent from industry. It approves that in the proposed revision of the articles of the law regarding the protection of persons participating in biomedical research, the distinction between research with of without direct individual benefit is removed. It notes that trials known as "non-interventional," meaning tested trials (studies in which the drugs which are used are already authorized or which use tested therapeutic strategies) are not concerned by the directive. The Academy would like these trials to be better defined in order to avoid any ambiguity. It would like to see the creation of a registry of French trials as well as the rapid publication of epidemiological studies or therapeutic trials whose results could have important consequences for Public Health. The realization of large trials requires European cooperation, therefore the harmonization of legislation in the member States of the E.U. is a necessity; this should lead to the creation of a European structure of appeal in this field.

Current protocol of a research phase I clinical trial of full-length dystrophin plasmid DNA in Duchenne/Becker muscular dystrophies: Part II: clinical protocol

A phase I open clinical study on gene therapy in Duchenne and Becker muscular dystrophy, without direct individual benefit for the patient, is being performed at the Pitié-Salpêtrière Hospital, Paris. The aims of this project are: (a) to determine the tolerance and the safety of the intramuscular administration of dystrophin cDNA and (b) to study the quality of the gene transfer in vivo in human patients affected by Duchenne and Becker muscular dystrophy. This clinical trial is conducted sequentially and includes three cohorts of three patients each. Patients must be at least 15 years of age. Diagnosis of Duchenne and Becker muscular dystrophy was confirmed by molecular analysis of the dystrophin gene and for each patient the abnormal expression of dystrophin was confirmed, in skeletal muscle, with antibodies directed against the deleted part of the dystrophin. This phase I study is scheduled to be completed by the end of 2002.

Rationale for a trial of prevention of perinatal transmission of hepatitis C via specific immunoglobulins

Vertical transmission of the HCV infection is asymptomatic, occurring in 0-25% of infants born to viremic mothers in Europe. Nowadays, the only preventive measure in to advise against breastfeeding. Favourable conditions for a seroprophylaxis trial in neonates at risk are the low viral charge and the absence of former replication or integration. Several impediments to a randomized-controlled trial should be considered: Epidemiological: paucity of recruitment; low risk of transmission; possible antenatal transmission in cases of high maternal viremia; risk for intrafamilial transmission. Methodological: complex randomization of the study groups (genotyping, quantitative PCR, activity of mothers' diseases, modes/durations of delivery and feeding). Ethical: a direct individual benefit is not clearly established; should viremic mothers be allowed to breast feed their babies in the absence of prophylaxis? the risk of the emergence of mutants or quasi-species of the transmitted hepatitis C virus in neonates; the origin and selection of seropositive plasma donors.