Dataset Information

Attitudes to drug trials among relatives of unconscious intensive care patients.

ABSTRACT:

Background

In many countries relatives are asked to consent on behalf of ICU patients prior to inclusion in clinical trials. However, the attitudes to drug trials among relatives of unconscious ICU patients are largely unknown.

Methods

We performed a prospective questionnaire survey at two university hospital ICUs of the next-of-kin to 50 unconscious adult patients. They were asked to complete a questionnaire within 48 hours of the patients' acute ICU admission.

Results

Forty-two relatives returned the questionnaire of which 41 were completed by direct family members and in one case by a friend to the patient.The majority of relatives (36/42) were positive/positive with some scepticism towards performing drug trials in unconscious ICU patients and 30/42 would most likely accept trial-participation by their relative. The majority (30/42) agreed that they should decide if their relative was to participate in a drug trial and 24 of these found that the treating clinician/ICU consultant should also consent. The majority (27/42) found that deferred consent would be acceptable if there was a limited time frame for initiation of treatment, however 8 respondents found this unacceptable when the intervention was a new drug.The majority of relatives stipulated that adherence to legislation, treatment benefit for the study patient and for future patients, no patient-risk or -discomfort and development of new drugs were important factors if their relative was to participate in an ICU drug trial. When questioned about doctors' motives for performing drug trials the wish for drug development and better patient care were highly rated among relatives.

Conclusions

In general, relatives to unconscious ICU patients expressed positive attitudes to drug trials in the ICU and the inclusion of their relative in drug trials. Consent by next-of-kin and deferred consent was acceptable to the majority of relatives.

SUBMITTER: Perner A

PROVIDER: S-EPMC2890661 | biostudies-literature | 2010 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Attitudes to drug trials among relatives of unconscious intensive care patients.

Perner Anders A Ibsen Michael M Bonde Jan J

BMC anesthesiology 20100526

<h4>Background</h4>In many countries relatives are asked to consent on behalf of ICU patients prior to inclusion in clinical trials. However, the attitudes to drug trials among relatives of unconscious ICU patients are largely unknown.<h4>Methods</h4>We performed a prospective questionnaire survey at two university hospital ICUs of the next-of-kin to 50 unconscious adult patients. They were asked to complete a questionnaire within 48 hours of the patients' acute ICU admission.<h4>Results</h4>For ...[more]

PMID: 20504325

Similar Datasets

Project description:Background:Analgosedation is a cornerstone therapy for mechanically ventilated patients in intensive care units (ICU). To avoid inadequate sedation and its complications, monitoring of analgosedation is of great importance. The aim of this study was to investigate whether monitoring of analgosedative drug concentrations (midazolam and sufentanil) might be beneficial to optimize analgosedation and whether drug serum concentrations correlate with the results of subjective (Richmond Agitation-Sedation Scale [RASS]/Ramsay Sedation Scale) and objective (bispectral (BIS) index) monitoring procedures. Methods:Forty-nine intubated, ventilated, and analgosedated critically ill patients treated in ICU were clinically evaluated concerning the depth of sedation using RASS Score, Ramsay Score, and BIS index twice a day. Serum concentrations of midazolam and sufentanil were determined in blood samples drawn at the same time. Clinical and laboratory data were statistically analyzed for correlations using the Spearman's rank correlation coefficient rho (?). Results:Average age of the population was 57.8?±?16.0 years, 61% of the patients were males. Most frequent causes for ICU treatments were sepsis (22%), pneumonia (22%), or a combination of both (25%). Serum concentrations of midazolam correlated weakly with RASS (??=?-?0.467) and Ramsay Scores (??=?0.476). Serum concentrations of sufentanil correlated weakly with RASS (??=?-?0.312) and Ramsay Scores (??=?0.295). Correlations between BIS index and serum concentrations of midazolam (??=?-?0.252) and sufentanil (??=?-?0.166) were low. Conclusion:Correlations between drug serum concentrations and clinical or neurophysiological monitoring procedures were weak. This might be due to intersubject variability, polypharmacy with drug-drug interactions, and complex metabolism, which can be altered in critically ill patients. Therapeutic drug monitoring is not beneficial to determine depth of sedation in ICU patients.

Project description:BACKGROUND:Memory gaps in intensive care unit (ICU) survivors are associated with psychiatric disorders. The ICU diaries improve the patient's factual memory of the ICU, but it is not clear if they reduce the incidence of psychiatric disorders in patients and relatives after hospital discharge. The aim of this study is to evaluate the literature on the effect of ICU diaries for patients admitted in ICU and their relatives. METHODS:Two authors independently searched the online databases PubMed, OVID, Embase, EBSCO host, and PsycINFO from inception to July 2019. Studies were included if the intervention group (ICU diary) was compared with a group with no diaries and the sample was comprised patients ??18?years old admitted in the ICU for more than 24?h and their relatives. Randomized clinical trials, observational studies, letter with original data, and abstracts were included, irrespective of the language. The search was not limited by any specific outcome. Review articles, commentaries, editorials, and studies without a control group were excluded. Structured tools were used to assess the methodological quality ("Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I)" for cohort studies and the "Cochrane Risk of Bias tool" for included RCTs and before/after studies). A random-effects model was employed considering the anticipated variability between the studies. RESULTS:Seven hundred eighty-five titles were identified for screening. Two additional studies were selected after a reference search, and after a full-text review, a total of 12 studies were included. When pooling the results, ICU diary was associated with lower risk of depression (RR 0.41, 95% CI 0.23-0.75) and better quality of life (10.3 points higher in SF-36 general health score, 95% CI 0.79-19.8), without a decrease in anxiety or post-traumatic stress disorder (PTSD). For the relatives receiving an ICU diary, there was no difference in the incidence of PTSD, anxiety, or depression. CONCLUSION AND RELEVANCE:This systematic review and meta-analysis supports the use of ICU diaries to reduce the risk of depression and preserve the quality of life of patients after ICU admission. ICU diaries do not seem to have any beneficial effect on the relatives of the patients. TRIAL REGISTRATION:PROSPERO, CRD42019136639.

Dataset Information

Attitudes to drug trials among relatives of unconscious intensive care patients.

Background

Methods

Results

Conclusions

Publications

Attitudes to drug trials among relatives of unconscious intensive care patients.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure