Informed consent for research in ICU obtained before ICU admission

Objective To analyze the procedure of the informed consent for ICU research obtained before ICU admission. Design Prospective, open, observational study. Setting 20-bed surgical ICU of a tertiary teaching university hospital and the ward before and after ICU. Patients Patients, scheduled for elective cardiac surgery, who accepted to participate in a coagulation study. Interventions Patients underwent the same informed consent procedure, including an oral presentation of the coagulation study and an informative leaflet the day before surgery on the ward. Measurements and results Between January and August 2001, we included 38 patients; 36 survived ICU. Ten to 12 days after surgery, 8/36 (22%) patients did not know they had participated in a study, and 9/36 (25%) could not recall the study purpose and the related risk. Patients with incomplete recall stayed longer in ICU [median (range): 4 (3–6) vs 3 (1–5) days; p = 0.004]. None of these patients (0/9 vs 10/27; p < 0.04) had read the informative leaflet AND asked at least one question during the informed consent procedure. Conclusions Even when the informed consent is obtained in the most optimal conditions for ICU research, its ethical value remains questionable. Indeed, a substantial number of patients were unaware of their study participation, or of the related purpose and risks. When the ICU stay is prolonged, we should at least repeatedly and actively (re)-inform patients about their study participation. Presented in part at the annual congress of the American Thoracic Society (ATS), May 2003, in Seattle, WA, USA     

Evaluation of informed consent in health research: a questionnaire survey

Scand J Caring Sci; 2010; 24; 56–64
Evaluation of informed consent in health research: a questionnaire survey Objective: Informed consent is ethically and legally required for all biomedical and health research involving human participants. This study analyses the realization of informed consent in health research from the point of view of healthy, voluntary adult participants. Empirical studies from this point of view are still rare. Design: A population‐based questionnaire survey. Participants:  The study population consisted of 1410 men and women aged 57–78 years who are participants in a randomized controlled intervention trial on the effects of physical exercise and diet at Kuopio Research Institute of Exercise Medicine (eastern Finland). Methods:  The data were collected in 2005–2007 using a questionnaire. The questionnaire was given to all able and willing participants (n = 1324) who were still involved in the exercise and diet study at the 3‐month intervention visit. The response rate was 91%. Results: The defined key elements of informed consent were information, understanding, competence, voluntariness and decision‐making. A majority of the participants estimated that these key elements were successfully realized in the exercise and diet intervention study. Conclusions: Despite the general satisfaction with the informed consent process in the exercise and diet intervention study, a minority of the participants were dissatisfied with the information they had received or did not understand this information completely. These findings highlight the essential question: Did all of the participants truly give their genuine informed consent? This carefully executed study reveals objectively the difficulties in distribution of information to healthy adult volunteers.     

ICU research: the impact of invasiveness on informed consent

Purpose

Studies into the preferences of patients and relatives regarding informed consent for intensive care unit (ICU) research are ongoing. We investigated the impact of a study’s invasiveness on the choice of who should give consent and on the modalities of informed consent.

Methods

At ICU discharge, randomized pairs of patients and relatives were asked to answer a questionnaire about informed consent for research. One group received a vignette of a noninvasive study; the other, of an invasive study. Each study comprised two scenarios, featuring either a conscious or unconscious patient. Multivariate models assessed independent factors related to their preferences.

Results

A total of 185 patients (40 %) and 125 relatives (68 %) responded. The invasiveness of a study had no impact on which people were chosen to give consent. This increased the desire to get more than one person to give consent and decreased the acceptance of deferred or two-step consent. Up to 31 % of both patients and relatives chose people other than the patient himself to give consent, even when the patient was conscious. A range of 3 to 17 % of the respondents reported that they would accept a waiving of consent. Younger respondents and individuals feeling coerced into study participation wanted to be the decision makers.

Conclusions

Study invasiveness had no impact on patients’ and relatives’ preferences about who should give consent. Many patients and relatives were reluctant to give consent alone. Deferred and two-step consent were less acceptable for the invasive study. Further work should investigate whether sharing the burden of informed consent with a second person facilitates participation in ICU research.     

Using decision aids may improve informed consent for research

This commentary argues that the existing approach towards obtaining informed consent for clinical research may be improved by using decision aids. Problems with the current approach include i) an emphasis on documentation to the detriment of good quality decision-making; ii) ad hoc rather than theory-based research studying how to improve informed consent; and iii) a lack of clarity around what is meant by ‘comprehension’ and how to measure it. Decision aids, which clearly improve patient treatment decisions but are new to decisions surrounding study participation, have strengths in precisely the areas where the informed consent literature is weak. Decision aids facilitate a process of decision-making, combining clear documentation, exercises to facilitate decision-making, and consultation. They are increasingly informed by theory and clear, empirically-derived standards. Furthermore, decision aid research has clearly defined and operationalized three indicators of good quality decision-making in situations where there is no objectively correct answer: demonstrable knowledge of key aspects of the decision, accurate perceptions of the probabilities of various outcomes, and a match between preferred outcomes and the choice made. We identify outstanding issues and propose a research approach that will determine whether the use of decision aids can improve the informed consent process.     

Adult ICU ventilators to provide neonatal ventilation: a lung simulator study

Background

Traditionally, specific ventilators have been manufactured to only provide neonatal mechanical ventilation. However, many of the current generation of ICU ventilators also include a neonatal mode.

Methods

Using the IngMar ASL5000 lung simulator the Puritan Bennett 840, the Maquet Servo i, the Viasys AVEA, the GE Engström, the Drager Evita XL and Babylog 8000 Plus were evaluated during assisted ventilation in the pressure assist/control mode. Three lung mechanics were set: resistance 50 cmH₂O/L/s, compliance 2 mL/cmH₂O; resistance 100 cmH₂O/L/s, compliance 1 mL/cmH₂O; and resistance 150 cmH₂O/L/s, compliance 0.5 mL/cmH₂O. A maximum negative pressure drop of 4 and 7 cmH₂O was achieved during simulated inspirations. Each ventilator was evaluated with PEEP 5 cmH₂O, peak pressure 20 cmH₂O and inspiratory time 0.3 s and with PEEP 10 cmH₂O, peak pressure 30 cmH₂O and inspiratory time 0.4 s. Each ventilator setting was then repeated with a leak of 0.3 L/min at a constant pressure of 5 cmH₂O.

Results

Overall each of the 5 ICU ventilators responded faster or greater than the Babylog with respect to: pressure to trigger (except the Servo i), time to trigger (except the Evita XL), time between trigger and return of pressure to baseline, time from start of breath to 90% of peak pressure (except the Avea) and pressure time product of breath activation. Expiratory tidal volume was also greater with all ICU ventilators except the Avea. Variation in mechanics, leak, PEEP and muscular effort had little effect on these differences.

Conclusion

All ICU ventilators tested were able to at least equal the performance of the Babylog 8000 Plus on all variables evaluated.

     

Cost burden of viral respiratory infections: Issues for formulary decision makers

Viral respiratory infections (VRIs) are a common malady associated with considerable costs in terms of decreased productivity and time lost from work or school, visits to health-care providers, and the amount of drugs prescribed. Both total respiratory illness and rhinovirus infection peak during the fall and spring seasons, although the average percentage of office visits by patients with a rhinovirus infection is moderately high throughout the year. Most common cold remedies are relatively ineffective and may produce side effects that contribute to increased health-care costs. Antibiotic therapy is widely overused and misused despite evidence that antibiotics fail to treat the cause of VRI or prevent secondary bacterial infections. Increasing use of antibiotics has a significant impact on health-care costs and the emergence of antimicrobial resistance. Reasons for overprescribing antibiotics are varied, but they often involve physician and patient attitudes and expectations. Although treatment of VRIs poses challenges for effective formulary management, several steps can be taken to facilitate the introduction of antiviral agents, including patient and provider education, the development of rapid diagnostic tests, and medical-economics studies to determine the true cost of antiviral therapy.     

Routine exploratory thoracentesis in ICU patients with pleural effusions: Results of a French questionnaire study

PURPOSE: The purpose of this study was to report the opinions of intensivists regarding pleural effusions in patients in the intensive care unit (ICU). MATERIALS AND METHODS: Questionnaires were sent to 1,032 intensivists, who were members of the French Society of Critical Care. RESULTS: Four hundred thirty-one questionnaires (41.7%) were returned. Overall, the respondents' estimated the incidence of pleural effusion in ICU patients to be 22.19 +/- 17%, whereas 37 +/- 27% considered that exploratory thoracentesis was likely to determine the cause of the effusion, and 17.36 +/- 16% considered that its results were likely to result in a change in their therapeutic attitude. Sixty-five (15%) physicians, chiefly pulmonologists, performed exploratory thoracentesis routinely (Group 1). Compared with those who did not perform routine thoracentesis (Group 2), they ascribed a higher proportion of pleural effusions to infection (31.3% vs. 13.5%) and were more likely to consider that exploratory thoracentesis had a diagnostic and therapeutic contribution (51.2% vs. 34% and 23% vs. 16%, respectively). In addition to the respiratory medicine subspecialty, the practice of routine exploratory thoracentesis was significantly related to seniority, to the frequency of the suspicion of an infectious cause in the physician's practice, and to his or her appreciation of the risks associated with exploratory thoracentesis. Physicians from Group 1 were also more likely to describe exploratory thoracentesis as a noninvasive procedure. CONCLUSIONS: The beliefs and attitudes of intensivists regarding pleural effusions and exploratory thoracentesis are divergent. This may be due to the lack of precise guidelines on the topic and prompt the design of further studies to establish precisely the epidemiology and causes of pleural effusions in ICU patients.     

Technology--an actor in the ICU: a study in workplace research tradition

Background. The present study focuses on human–machine interaction in an intensive care unit in the West of Sweden. Aims. The aim of the present study was to explore how technology intervenes and challenges the ICU staff's knowing in practice. Theoretical perspective. The study's theoretical starting point draws on workplace research tradition. Workplace studies encompass the interaction between the actors’ situated activities and the technological tools that make their activities possible. Method. Fieldwork or in situ studies of everyday practice in an intensive care unit documented in written field notes constituted the data. Results. The findings show first how technology intervenes in the division of labour when the taken‐for‐granted ‘old’ everyday practice is disrupted when a new machine intervenes in the morning's work; secondly, it reveal how technology challenges practical knowing and thirdly, it shows how technology reformulates practice. Staff members’ awareness of routine problems is often connected to the ability to see, which is always related to cultural/contextual competence. Conclusion. It is concluded that it is not talk alone that helps the caregivers to ‘(dis)solve’ the problems. The ability to see the problems, the work environment and to find the relevant supporting tools for ‘(dis)solving’ the routine problems is also crucial. But it is not possible to say that it is the skillful work of humans that solve problems, nor do we claim it is the tools that do so. Humans and tools are interwoven in the problem‐solving process. Relevance to clinical practice. Routine problems in the intensive care unit are not ‘(dis)solved’ through the cognitive work of individual staff members alone. Problems are also ‘(dis)solved’ jointly with other staff members. Staff members ‘borrow’ the knowing from each other and problems are re‐represented through communication. The knowing has to be distributed among the intensive care unit staff to make the everyday work flexible.     

ICU患者家属参与决策的现况研究

目的 了解ICU患者家属在决策中期望参与程度和实际参与情况,并分析决策参与期望的影响因素。方法 采用一般资料调查表和决策参与期望量表,对杭州市某三甲医院的100名ICU患者家属进行调查。结果 在决策参与期望的调查中,46.0%的家属选择合作型,35.0%的家属选择被动型,19.0%的家属选择主动型。家属参与决策的期望和实际情况存在差异,期望参与决策的程度高于实际参与水平（χ2=14.894,P<0.05）,两者一致性检验的Kappa值为0.272,符合率为54.0%。多元有序Logistic回归分析结果显示,家属的年龄、文化程度和性格是决策参与期望的主要影响因素。结论 近半数家属在决策中扮演了与期望不一致的参与角色,建议医护人员在决策前评估家属的决策参与期望水平,给予个性化的沟通方式,实施与之匹配的决策模式。     

Informed consent procedures in patients with an acute inability to provide informed consent: Policy and practice in the CENTER-TBI study

PurposeEnrolling traumatic brain injury (TBI) patients with an inability to provide informed consent in research is challenging. Alternatives to patient consent are not sufficiently embedded in European and national legislation, which allows procedural variation and bias. We aimed to quantify variations in informed consent policy and practice.MethodsVariation was explored in the CENTER-TBI study. Policies were reported by using a questionnaire and national legislation. Data on used informed consent procedures were available for 4498 patients from 57 centres across 17 European countries.ResultsVariation in the use of informed consent procedures was found between and within EU member states. Proxy informed consent (N = 1377;64%) was the most frequently used type of consent in the ICU, followed by patient informed consent (N = 426;20%) and deferred consent (N = 334;16%). Deferred consent was only actively used in 15 centres (26%), although it was considered valid in 47 centres (82%).ConclusionsAlternatives to patient consent are essential for TBI research. While there seems to be concordance amongst national legislations, there is regional variability in institutional practices with respect to the use of different informed consent procedures. Variation could be caused by several reasons, including inconsistencies in clear legislation or knowledge of such legislation amongst researchers.