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1.
JAMA ; 319(7): 680-690, 2018 02 20.
Article in English | MEDLINE | ID: mdl-29466591

ABSTRACT

Importance: Results of studies on use of prophylactic haloperidol in critically ill adults are inconclusive, especially in patients at high risk of delirium. Objective: To determine whether prophylactic use of haloperidol improves survival among critically ill adults at high risk of delirium, which was defined as an anticipated intensive care unit (ICU) stay of at least 2 days. Design, Setting, and Participants: Randomized, double-blind, placebo-controlled investigator-driven study involving 1789 critically ill adults treated at 21 ICUs, at which nonpharmacological interventions for delirium prevention are routinely used in the Netherlands. Patients without delirium whose expected ICU stay was at least a day were included. Recruitment was from July 2013 to December 2016 and follow-up was conducted at 90 days with the final follow-up on March 1, 2017. Interventions: Patients received prophylactic treatment 3 times daily intravenously either 1 mg (n = 350) or 2 mg (n = 732) of haloperidol or placebo (n = 707), consisting of 0.9% sodium chloride. Main Outcome and Measures: The primary outcome was the number of days that patients survived in 28 days. There were 15 secondary outcomes, including delirium incidence, 28-day delirium-free and coma-free days, duration of mechanical ventilation, and ICU and hospital length of stay. Results: All 1789 randomized patients (mean, age 66.6 years [SD, 12.6]; 1099 men [61.4%]) completed the study. The 1-mg haloperidol group was prematurely stopped because of futility. There was no difference in the median days patients survived in 28 days, 28 days in the 2-mg haloperidol group vs 28 days in the placebo group, for a difference of 0 days (95% CI, 0-0; P = .93) and a hazard ratio of 1.003 (95% CI, 0.78-1.30, P=.82). All of the 15 secondary outcomes were not statistically different. These included delirium incidence (mean difference, 1.5%, 95% CI, -3.6% to 6.7%), delirium-free and coma-free days (mean difference, 0 days, 95% CI, 0-0 days), and duration of mechanical ventilation, ICU, and hospital length of stay (mean difference, 0 days, 95% CI, 0-0 days for all 3 measures). The number of reported adverse effects did not differ between groups (2 [0.3%] for the 2-mg haloperidol group vs 1 [0.1%] for the placebo group). Conclusions and Relevance: Among critically ill adults at high risk of delirium, the use of prophylactic haloperidol compared with placebo did not improve survival at 28 days. These findings do not support the use of prophylactic haloperidol for reducing mortality in critically ill adults. Trial Registration: clinicaltrials.gov Identifier: NCT01785290.


Subject(s)
Antipsychotic Agents/administration & dosage , Critical Illness/mortality , Delirium/prevention & control , Haloperidol/administration & dosage , Adult , Aged , Antipsychotic Agents/adverse effects , Dose-Response Relationship, Drug , Double-Blind Method , Female , Haloperidol/adverse effects , Humans , Intensive Care Units , Male , Middle Aged , Proportional Hazards Models , Risk Factors , Survival Analysis
2.
Support Care Cancer ; 25(2): 677-685, 2017 02.
Article in English | MEDLINE | ID: mdl-27771786

ABSTRACT

Discussing do-not-resuscitate (DNR) orders is part of daily hospital practice in oncology departments. Several medical factors and patient characteristics are associated with issuing DNR orders in cancer patients. DNR orders are often placed late in the disease process. This may be a cause for disagreements between doctors and between doctors and patients and may cause for unnecessary treatments and admissions. In addition, DNR orders on itself may influence the rest of the medical treatment for patients. We present recommendations for discussing DNR orders and medical futility in practice through shared decision-making. Prospective studies are needed to investigate in which a patient's cardiopulmonary resuscitation (CPR) is futile and whether or not DNR orders influence the medical care of patients.


Subject(s)
Cardiopulmonary Resuscitation/ethics , Decision Making/ethics , Neoplasms/psychology , Resuscitation Orders/ethics , Humans , Male , Middle Aged , Neoplasms/therapy , Prospective Studies
3.
Disabil Rehabil ; 33(9): 734-42, 2011.
Article in English | MEDLINE | ID: mdl-20804446

ABSTRACT

PURPOSE: To develop an instrument that measures empowerment among people with a long-term work disability. METHODS: A six-dimension empowerment model was chosen as a theoretical framework. These dimensions are as follows: competence, self-determination, meaning, impact, positive identity and group orientation. A literature search was conducted to find instruments that currently are being used to measure one or more of these constructs. Validated and applicable instruments from this search were used in a preliminary questionnaire. A pilot test was conducted consulting the target population and experts. On basis of changes from this pilot, a concept questionnaire was conducted. In a field test, this questionnaire was sent to 976 subjects who followed a vocational rehabilitation course in the years 2001-2003. Item-total correlations and factor analyses were performed on the collected data to reduce the number of items. Factor analysis was performed, and internal consistency was determined to get insight into the psychometric properties of the final questionnaire. RESULTS: From all subjects who were approached, 385 (39%) returned usable questionnaires that could be analysed. Item reduction by item-total correlations and factor analysis resulted in a final questionnaire consisting of 62 items divided over the six subscales. Internal consistency of the subscales was good: all subscales had Cronbach's alphas between 0.80 and 0.91. Some inter-correlation existed between the subscales competence, self-determination and impact. CONCLUSIONS: The 'VrijBaan' questionnaire was developed to measure empowerment among people with a long-term work disability. Although the results support the internal consistency of the subscales, further psychometric work is needed to improve the quality of this questionnaire.


Subject(s)
Disabled Persons/psychology , Power, Psychological , Sick Leave/statistics & numerical data , Surveys and Questionnaires , Adaptation, Psychological , Disability Evaluation , Disabled Persons/statistics & numerical data , Female , Humans , Long-Term Care , Male , Models, Theoretical , Pilot Projects , Quality of Life , Rehabilitation, Vocational/methods , Risk Assessment , Time Factors , Workers' Compensation/statistics & numerical data
4.
Biometrics ; 58(1): 178-84, 2002 Mar.
Article in English | MEDLINE | ID: mdl-11892689

ABSTRACT

We propose a new method to analyze outbreak data of an infectious disease such as classical swine fever. The underlying model is a two-type branching process. It is used to deduce information concerning the epidemic from detected cases. In particular, the method leads to prediction of the future course of the epidemic and hence can be used as a basis for control policy decisions. We test the model with data from the large 1997-1998 classical swine fever epidemic in The Netherlands. It turns out that our results are in good agreement with the data.


Subject(s)
Classical Swine Fever/epidemiology , Disease Outbreaks/veterinary , Epidemiologic Methods/veterinary , Models, Statistical , Animals , Classical Swine Fever Virus/growth & development , Netherlands/epidemiology , Swine
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