Impact of informed consent requirements on cardiac arrest research in the United States: exception from consent or from research?

INTRODUCTION: Research in patients with life-threatening illness such as cardiac arrest is challenging since they can not consent. The Food and Drug Administration addressed research under emergency conditions by publishing new criteria for exception from informed consent in 1996. We systematically reviewed randomized trials over a 10-year period to assess the impact of these regulations. METHODS: Case-control study of published trials for cardiac arrest (cases) and atrial fibrillation (controls.) Studies were identified by using structured searches of MEDLINE and EMBASE from 1992 to 2002. Included were studies using random allocation in humans with cardiac arrest or atrial fibrillation prior to enrollment. Excluded were duplicate publications. Number of American trials, foreign trials and proportion of trials of American origin were compared by using regression analysis. Changes in cardiac arrest versus atrial fibrillation trials were calculated as risk differences. RESULTS: Of 4982 identified cardiac arrest studies, 57 (1.1%) were randomized trials. The number of American cardiac arrest trials decreased by 15% (95% CI: 8, 22%) annually (P = 0.05). The proportion of cardiac arrest trials of American origin decreased by 16% (95% CI: 10, 22%) annually (P = 0.006). Of 5596 identified atrial fibrillation studies, 197 trials (3.5%) were randomized trials. The risk difference between cardiac arrest versus atrial fibrillation trials being of American origin decreased significantly (annual difference -5.8% (95% CI: -10, -0.1%), P = 0.03). INTERPRETATION: Fewer American cardiac arrest trials were published during the last decade, when federal consent requirements changed. Regulatory requirements for clinical trials may inhibit improvements in care and threaten public health.     

Universal design and the challenge of diversity: reflections on the principles of UD,based on empirical research of people’s mobility

Abstract

Purpose: The author analyses some theoretical presuppositions of the Universal Design approach. She shows that it is based on two paradoxes: (1) it reduces diversity to the “universal”, (2) it depends on an asymmetrical view of abilities and disabilities. The author suggests a way of changing this concept in order to take into account uniqueness and diversity, in order to allow the shaping of abilities. Methods: The data are taken from an ethnographical survey carried out between 2007 and 2009 made up of in-depth interviews with wheelchair users and their families. The interviews were analysed inductively using the Nvivo© programme. Results: The mobility of people in wheelchairs, and their capacity to act, are linked to their particular experience and are the result of a process of adjustment and arrangement. This process involves specific and varied resources and leads to changes in the individuals, in their dis/abilites, but also in their perceptions. Conclusions: This analysis leads to a change in the question of policy. This question is no longer “how to include diversity using the definition of ‘universal’”, but “how to bring out and articulate this diversity, so as to vary the qualities of persons and the world in which they live”.

• Implications for Rehabilitation

• “Inaccessibility” is analysed in terms of a discrepancy between the user and her/his environment and in terms of experience.

• Accessibility is analysed as a process of adjustment and practical arrangements between the person and her/his environment.

• The universalism of Universal Design is criticized in the way it tries to force the variety of users into the uniqueness of one materiality.

• Emphasis is put on diversity and the necessity of articulating this diversity in a plural world offering various resources that individuals can call upon to act, depending on what they are and on what they want to become.

     

Impact of Kendall,Hollon, Beck,Hammen, and Ingram (1987) on treatment of the continuity issue in “depression” research

The article, Issues and Recommendations Regarding Use of the Beck Depression Inventory (Kendall, Hollon, Beck, Hammen, & Ingram, 1987), has had a major impact on depression research. A majority of studies using only the BDI in nonclinical samples now refer to the construct measured as dysphoria rather than depression. This word change, however, is not always accompanied by other changes in research design and interpretation that would seem warranted by the concerns that initially prompted the dysphoria recommendation, such as the nonspecificity of high BDI scores to major depression. Researchers typically continue to derive hypotheses from depression theory, use only the BDI to measure dysphoria rather than purer markers of negative affectivity, cite as a limitation of their findings the danger of assuming continuity between subclinical and clinical depression, and sometimes lapse into depression terminology. Alternative suggestions are made for considering how the particular goals of a study might lead to various ways of handling the continuity issue.We are grateful to Tony Ahrens, Diane Arnkoff, and anonymous reviewers for feedback on earlier drafts.     

Impact of the nurse-related information through social media use on undergraduate nursing students’ professional identity in nursing: A mixed-methods study

AimTo understand the impact of nurse-related information, through social media usage on undergraduate nursing students’ professional identity.BackgroundPrevious research has addressed professional knowledge and practice that affect the development of undergraduate nursing students’ professional identities. As an increasingly crucial factor in the internet age, social media needs to be explored in-depth for its influence on the professional identity in nursing.DesignSequential explanatory mixed method was used in this study.MethodsIn this quantitative study, participants (N = 698) completed an e-questionnaire survey between June and July of 2020. The relationship between main variables was analyzed by linear regression using SPSS 20.0. Then, face-to-face semi-structured and audio-recorded interviews were carried out among participants (N = 16) between January and March of 2021.ResultsThe quantitative findings indicated that the mean score of professional identity was 93.07 ± 11.96 in participants. The results of the linear regression showed that the year in school, whether nursing was the first choice, online time per day, frequency of reading official accounts related nursing on WeChat and appraisal of the online nurse-related information and so on explained 49.0 % of the variance in professional identity. Four major themes emerged from the qualitative study: 1) increased concern; 2) few and non-professional information; 3) encouraged by positive information; 4) limited impact of negative information.ConclusionsNurse-related information on social media has the potential to have an impact on undergraduate nursing students’ professional identity. Nursing educators should guide undergraduate nursing students to use social media appropriately and assist them in developing their professional identity with it.     

Standard of living in the retirement survey: A predictor of six-year functional limitation onset and mortality in women,but not in men from ages 55 – 69 years

Purpose.?To investigate the predictive validity for health decline of a standard of living, a measure that combines basic necessities and consumer durables.

Method.?A nationally representative sample of those aged 55?–?69 years was interviewed at home in the Great Britain Retirement and Retirement Plans Survey, (1988; n?=?3541). In 1994, 2247 were re-interviewed, response rate being 70% of survivors. Relationships between socioeconomic status and health decline were investigated using polytomous logistic regression modelling. The outcomes were onset of functional limitation and mortality.

Results.?Standard of living was an independent predictor of 6-year functional limitation onset (Odds Ratio compared to good standard of living 2.2; 95% Confidence Interval 1.3?–?3.8) and mortality (OR?=?4.6; 95% CI 2.3?–?8.9) in women, with age, household type, educational qualifications and social class taken into account. However, in men, weaker associations were largely accounted for by differences in education and social class (adjusted OR for functional limitation onset 1.0; 95% CI 0.5?–?1.9; adjusted OR for mortality 1.4; 95% CI 0.6?–?2.9). A combined indicator of housing tenure and property value was also an independent predictor of functional limitation onset in women.

Conclusions.?Poor standard of living identifies women but not men at risk of health decline who are missed by social class and educational level. Measures of current home-based material resources are a useful addition to minimum datasets for monitoring health inequalities.     

Patterns in information strategies used by older men to understand and deal with prostate cancer: an application of the modélisation qualitative research design

BACKGROUND: The increasing need of older individuals to safely self-manage their chronic illnesses requires that they clearly understand health-related information. Thus, this study examined health literacy as lived by men with prostate cancer (PC), rather than as assessed by professionals. OBJECTIVES: This study aimed to describe, analyse, and understand informational strategies of men with PC. The main objective was to describe these strategies according to self-assessed levels of functional health literacy and thus create an inventory of strategy characteristics. DESIGN: The modélisation qualitative research design framed this inquiry. SETTINGS: Montreal and Laval, province of Québec, Canada. PARTICIPANTS: The purposive sample comprised 15 French-Canadian men aged 61-83, most of whom were enroled in a PC support group. Recruitment and selection was assisted by the support group's chairman and a volunteer recruiter. Selection criteria were medical diagnosis of localised PC, childhood spent in Québec, ability to self-assess functional health literacy, effective oral communication in French, no use of psychotropic drugs, and normal time and space orientation. METHODS: Data collection involved semi-structured interviews and drawing of genograms and ecomaps. The qualitative-data-analysis software Atlas. ti (Version 4.1 for Windows) was used to code the interview data. Findings were also subjected to content analysis. Six volunteers examined and confirmed the authors' interpretation of the findings. RESULTS: Functional health literacy was cultivated throughout participants' lives and nourished by their social and cultural resources. A history of reading at home, interest in learning, supportive family and elementary school environments developed open-minded, critical-information-seeking older men. The findings did not support any association among formal education, level of health literacy, and ways of dealing with PC-related information. The construction of information networks provided participants with knowledge and with emotional and spiritual support to cope with PC. Men with different levels of health literacy had both unique and similar information strategies. CONCLUSIONS: Participants' decisions to adopt specific information strategies were influenced by awareness of impacts of PC on men's lives, construction and maintenance of information networks, as well as participants' critique of health information. Through their information strategies, participants regained decision-making power over their bodies and destinies, and then redefined their social roles.     

Impact of delayed repair and elective high-frequency oscillatory ventilation on survival of antenatally diagnosed congenital diaphragmatic hernia: first application of these strategies in the more “severe” subgroup of antenatally diagnosed newborns

Objective: a) To analyze the influence of a new management strategy on the outcome of neonates with antenatally diagnosed congenital diaphragmatic hernia (CDH); b) to determine early prognosis respiratory factors with the new strategy.¶Design: Retrospective study. Setting: Level III perinatal center. Patients and method: Between 1985 and 1997, 51 consecutive neonates with antenatally diagnosed CDH were admitted to our level III neonatal intensive care unit. Before 1992 (period 1; n = 19), we used conventional mechanical ventilation and early surgery requiring transfer. Since 1992 (period 2; n = 32), we prospectively tested a new approach including (a) systematically use of high-frequency oscillatory ventilation (HFOV) regardless of the initial clinical severity, (b) delayed surgery following stabilization requiring transfer to a different surgical unit, but (c) no transfer of unstable patients with surgery under HFOV in our neonatal intensive care unit (n = 10). The two cohorts were comparable in terms of potential ante and postnatal prognostic indicators. Results: Survival was improved with the new strategy: 21/32 (66 %) vs. 5/19 (26 %); P < 0.02. This improvement between periods 1 and 2 was due to a decrease in both preoperative and postoperative deaths in the later period. The better survival during period 2 was associated with the appearance of very late deaths, frequent pleural effusions, and the survival of more severe forms having evolved to a chronic respiratory insufficiency. Survivors were ventilated for longer time with longer duration of oxygen supplementation. The best oxygenation index (OI), alveolar arterial difference and oscillation amplitude (P/P) during the first 24 h, but not the best PaCO₂, were the most reliable prognostic indicators during period 2. An OI ≤ 10 with a P/P ≤ 55 cmH₂O was associated with a very good prognosis (94 % survival). Conclusions: The prognosis of antenatally diagnosed CDH was improved by systematic HFOV on admission, no systematic transfer, and delayed surgery. This improvement is associated with modification of postnatal outcome.     

Impact of economic fluctuations on suicide mortality in Canada (1926–2008): Testing the Durkheim,Ginsberg, and Henry and Short theories

Three theories have been proposed to explain the relationship between suicide and economic fluctuations, including the Durkheim (nonlinear), Ginsberg (procyclical), and Henry and Short (countercyclical) theories. This study tested the effect of economic fluctuations, measured by unemployment rate, on suicide rates in Canada from 1926 to 2008. Autoregressive integrated moving average time-series models were used. The results showed a significant relationship between suicide and economic fluctuation; this association was positive during the contraction period (1926–1950) and negative in the period of economic expansion (1951–1973). Males and females showed differential effects in the period of moderate unemployment (1974–2008). In addition, the suicide rate of mid-adults (45–64) was most impacted by economic fluctuations. Our study tends to support Durkheim’s theory and suggests the need for public health responses in times of economic contraction and expansion.     

Addition of plerixafor to G-CSF in poor mobilizing healthy related donors overcame mobilization failure: An observational case series on behalf of the Grupo Español de Trasplante Hematopoyético (GETH)

Plerixafor (Mozobil, Sanofi) is approved for using in patients with lymphoma and multiple myeloma when steady-state mobilization strategies fail. Although off-label use of plerixafor in healthy related donors (HRD) is known, limited data are available and no recommendations exist to guide its use in this setting. With the aim of collecting data from HRDs who received plerixafor in our country, we designed an observational case series study within the Spanish Group of Hematopoietic Transplant and Cell Therapy (GETH). Plerixafor was administered subcutaneously to 30 HRDs at a median dose of 0.24 mg/Kg (interquartile range (IQR): 0.23?0.25) because mobilization failure after using mobilization with G-CSF (mobilization failure was defined as collection of <4.0 × 10⁶ CD34+ cells/Kg recipient). All HRDs received G-CSF at a median dose of 11 μg/Kg/day (IQR: 10–12) for 4–5 days. Leukocytapheresis after G-CSF mobilization was performed in 23 (77 %) HRDs collecting a median of 1.6 × 10⁶ CD34+ cells/Kg recipient weight (IQR: 0.9–2.5). Addition of plerixafor allowed the collection of a higher median number of CD34 cells (4.98 × 10⁶ CD34+ cells/Kg recipient weight (IQR: 3.5–5.8)) when compared with the collection of CD34+ cells with G-CSF alone (p < 0.01). The final median total number of CD34+ cells collected was 6.1 × 10⁶/Kg recipient weight (IQR: 4.8–7.3). Mild adverse events related with plerixafor administration were reported in 8 (27 %) donors. In conclusion, addition of plerixafor after G-CSF mobilization failure in HRDs allowed collecting higher number of CD34+ cells in comparison with steady-state mobilization.