Patient and Surrogate Views of Community Consultation for Emergency Research

ObjectivePretrial community consultation (CC) is required for emergency research conducted under an exception from informed consent (EFIC) in the United States. CC remains controversial and challenging, and minimal data exist regarding the views of individuals enrolled in EFIC trials on this process. It is important to know whether participants perceive CC to be meaningful and, if so, whom they believe should be consulted.MethodsWe conducted a secondary analysis of data from two studies interviewing patients and surrogates of two recent EFIC trials (PEER‐RAMPART and PEER‐ProTECT). These interviews included similar open‐ and closed‐ended questions regarding participants’ views of the importance of CC, the rationale for their responses, and their views regarding which populations should be included in consultation efforts. A template analytic strategy was used for qualitative analysis of textual data, and descriptive statistics were tabulated to characterize demographic data and instances of major themes.ResultsNinety percent of participants perceived CC to be valuable. Participants’ reasons for finding CC valuable clustered in two categories: 1) as a method of informing the public about the trial to be conducted and 2) as a way of obtaining input and feedback from the community. Participants cited the medical community (43%) and individuals with a connection to the study condition (41%) as the most important groups to involve in consultation efforts; only 5% suggested consulting the general public in the area where the research will be conducted.ConclusionParticipants in EFIC trials and their decision makers generally valued CC as a method of informing and seeking input from the community. Participants felt that the most appropriate groups to consult were the medical community and individuals with connections to the condition under study. Consultation efforts focused on these two groups, rather than the general public, may be more efficient and more meaningful to individuals involved in EFIC trials. These findings also reinforce the importance of the distinction between public disclosure and CC.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/139974/1/acem13265-sup-0001-DataSupplementS1.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/139974/2/acem13265_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/139974/3/acem13265.pd

Unemployment Insurance and Low-Educated Single Working Mothers Before and After Welfare Reform

Using the Survey of Income and Program Participation (SIPP), a nationally representative, longitudinal survey, this study examines changing levels of Unemployment Insurance (UI) eligibility and benefit receipt among working low-educated single mothers, 1990–2005. It also examines changing participation in cash welfare and the Food Stamp Program (FSP). Relative to single childless women, there has been no increase in UI benefit receipt among single mothers entering a spell of unemployment in the postreform period, even though single mothers have increased their relative rates of UI eligibility. Because of declining cash assistance receipt, UI became a more common income support than cash assistance for this population during the period 2001–2005. Furthermore, the probability of accessing FSP for low-educated single mothers entering a spell of unemployment increased in the years 2001–2005. As a result, the proportion of this population accessing benefits from one or more of these programs remained virtually unchanged across the study period

Experimental determination of the permeability of engineering textiles: Benchmark II

In this second international permeability benchmark, the in-plane permeability values of a carbon fabric were studied by twelve research groups worldwide. One participant also investigated the deformation of the tested carbon fabric. The aim of this work was to obtain comparable results in order to make a step toward standardization of permeability measurements. Unidirectional injections were thus conducted to determine the unsaturated in-plane permeability tensor of the fabric. Procedures used by participants were specified in the guidelines defined for this benchmark. Participants were asked to use the same values for parameters such as fiber volume fraction, injection pressure and fluid viscosity to minimize sources of scatter. The comparison of the results from each participant was encouraging. The scatter between data obtained while respecting the guidelines was below 25%. However, a higher dispersion was observed when some parameters differed from the recommendations of this exercise.The authors are grateful to J.M. Beraud from Hexcel Fabrics for his support that made possible this exercise. The contributions of J.B. Alms, N.C. Correia, S. Advani, E. Ruiz and P.C.T. Goncalves to the preparation of the guidelines document and templates are acknowledged by the participants of this benchmark.Vernet, N.; Ruiz, E.; Advani, S.; Alms, JB.; Aubert, M.; Barburski, M.; Barari, B.... (2014). Experimental determination of the permeability of engineering textiles: Benchmark II. Composites Part A: Applied Science and Manufacturing. 61:172-184. doi:10.1016/j.compositesa.2014.02.010S1721846

The implications of autonomy: Viewed in the light of efforts to uphold patients dignity and integrity

This article focuses on Danish patients’ experience of autonomy and its interplay with dignity and integrity in their meeting with health professionals. The aim is to chart the meanings and implications of autonomy for persons whose illness places them in a vulnerable life situation. The interplay between autonomy and personal dignity in the meeting with health care staff are central concepts in the framework. Data collection and findings are based on eight qualitative semi-structured interviews with patients. Patients with acute, chronic, and life threatening diseases were represented including surgical as well as medical patients. The values associated with autonomy are in many ways vitalising, but may become so dominant, autonomy seeking, and pervasive that the patient's dignity is affected. Three types of patient behaviour were identified. (1) The proactive patient: Patients feel that they assume responsibility for their own situation, but it may be a responsibility that they find hard to bear. (2) The rejected patient: proactive patients take responsibility on many occasions but very active patients are at risk of being rejected with consequences for their dignity. (3) The knowledgeable patient: when patients are health care professionals, the patient's right of self-determination was managed in a variety of ways, sometimes the patient's right of autonomy was treated in a dignified way but the opposite was also evident. In one way, patients are active and willing to take responsibility for themselves, and at the same time they are “forced” to do so by health care staff. Patients would like health professionals to be more attentive and proactive

Key stakeholder perceptions about consent to participate in acute illness research: a rapid, systematic review to inform epi/pandemic research preparedness

Background A rigorous research response is required to inform clinical and public health decision-making during an epi/pandemic. However, the ethical conduct of such research, which often involves critically ill patients, may be complicated by the diminished capacity to consent and an imperative to initiate trial therapies within short time frames. Alternative approaches to taking prospective informed consent may therefore be used. We aimed to rapidly review evidence on key stakeholder (patients, their proxy decision-makers, clinicians and regulators) views concerning the acceptability of various approaches for obtaining consent relevant to pandemic-related acute illness research. Methods We conducted a rapid evidence review, using the Internet, database and hand-searching for English language empirical publications from 1996 to 2014 on stakeholder opinions of consent models (prospective informed, third-party, deferred, or waived) used in acute illness research. We excluded research on consent to treatment, screening, or other such procedures, non-emergency research and secondary studies. Papers were categorised, and data summarised using narrative synthesis. Results We screened 689 citations, reviewed 104 full-text articles and included 52. Just one paper related specifically to pandemic research. In other emergency research contexts potential research participants, clinicians and research staff found third-party, deferred, and waived consent to be acceptable as a means to feasibly conduct such research. Acceptability to potential participants was motivated by altruism, trust in the medical community, and perceived value in medical research and decreased as the perceived risks associated with participation increased. Discrepancies were observed in the acceptability of the concept and application or experience of alternative consent models. Patients accepted clinicians acting as proxy-decision makers, with preference for two decision makers as invasiveness of interventions increased. Research regulators were more cautious when approving studies conducted with alternative consent models; however, their views were generally under-represented. Conclusions Third-party, deferred, and waived consent models are broadly acceptable to potential participants, clinicians and/or researchers for emergency research. Further consultation with key stakeholders, particularly with regulators, and studies focused specifically on epi/pandemic research, are required. We highlight gaps and recommendations to inform set-up and protocol development for pandemic research and institutional review board processes