Actigraphy in agitated patients with dementia : Monitoring treatment outcomes

Especially in pharmacotherapeutic research, a variety of methods to monitor behavioural and psychological symptoms of dementia (BPSD) are currently being discussed. To date, the most frequently used of these are clinical scales, which, however, are subjective and highly dependent on personnel resources. In our study, we tested the usefulness of actigraphy as a more direct and objective way to measure day-night rhythm disturbances and agitated behaviour.After a baseline assessment, 24 patients with probable dementia of the Alzheimer type (NINCDS-ADRDA) and agitated behaviour received either 3 mg melatonin (n=7), 2.5 mg dronabinol (n=7), or placebo (n=10) for two weeks. In addition, 10 young and 10 elderly healthy subjects were examined as a control group. Motor activity levels were assessed using an actigraph worn continuously on the wrist of the non-dominant hand. At the beginning and the end of the study, patients' Neuropsychiatric Inventory (NPI) scores were also assessed.In the verum group, actigraphic nocturnal activity (P=0.001), NPI total score (P=0.043), and NPI agitation subscale score (P=0.032) showed significant reductions compared to baseline. The treatment-baseline ratio of nocturnal activity (P=0.021) and treatment-baseline difference of the nocturnal portion of 24 h activity (P=0.012) were reduced. Patients' baseline activity levels were similar to those seen in healthy elderly subjects. Younger healthy subjects exhibited higher motor activity even at night. There was no correlation between actigraphy and NPI.Both actigraphic measures and the gold standard clinical scale were able to distinguish between the verum and placebo groups. However, because they did not correlate with each other, they clearly represent different aspects of BPSD, each of which reacts differently to therapy. As a result, actigraphy may well come to play an important role in monitoring treatment success in BPSD.

Rapid tranquilization of severely agitated patients with schizophrenia spectrum disorders: a naturalistic, rater-blinded, randomized, controlled study with oral haloperidol, risperidone, and olanzapine

INTRODUCTION Agitation is a major problem in acute schizophrenia. Only a few studies have tested antipsychotic agents in severely agitated patients, mainly because of legal issues. Furthermore, most studies were limited to the first 24 hours. We aimed to investigate the efficacy of oral haloperidol, risperidone, and olanzapine in reducing psychotic agitation in severely agitated patients with schizophrenia or schizophreniform or schizoaffective disorder over 96 hours using a prospective, randomized, rater-blinded, controlled design within a naturalistic treatment regimen. METHODS In total, 43 severely agitated patients at acute care psychiatric units were enrolled. Participants were randomly assigned to receive either daily haloperidol 15 mg, olanzapine 20 mg, or risperidone 2 to 6 mg over 5 days. Positive and Negative Syndrome Scale psychotic agitation subscale score was the primary outcome variable. A mixed-model analysis was applied. RESULTS All drugs were effective for rapid tranquilization within 2 hours. Over 5 days, the course differed between agents (P < 0.001), but none was superior. Dropouts occurred only in the risperidone and olanzapine groups. Men responded better to treatment than did women during the initial 2 hours (P = 0.046) as well as over the 5-day course (P < 0.001). No difference between drug groups was observed regarding diazepam or biperiden use. CONCLUSIONS Oral haloperidol, risperidone, and olanzapine seem to be suitable for treating acute severe psychotic agitation in schizophrenia spectrum disorders. Response to oral antipsychotics demonstrated a gender effect with poorer outcome in women throughout the study.

Rapid tranquilization of severely agitated patients with schizophrenia spectrum disorders: a naturalistic, rater-blinded, randomized controlled study with oral haloperidol, risperidone, and olanzapine

Agitation is a major problem in acute schizophrenia. Still, only limited evidence exists on antipsychotic efficacy in severely agitated patients after the first 24 hours. We aimed to investigate the efficacy of oral haloperidol, risperidone, and olanzapine in reducing psychotic agitation in severely agitated patients with schizophrenia or schizophreniform or schizoaffective disorder over 96 hours using a prospective, randomized, rater-blinded, controlled design within a naturalistic treatment regimen. We enrolled 43 severely agitated patients at acute care psychiatric units. Participants were randomly assigned to receive either daily haloperidol 15 mg, olanzapine 20 mg, or risperidone 2 – 6 mg over 5 days. Positive and Negative Syndrome Scale psychotic agitation (PANSS-PAS) subscore was the primary outcome variable. A mixed model analyses was applied. All drugs were effective for rapid tranquillization within 2 hours. Over 5 days, the course differed between agents (p < 0.001) but none was superior. Dropouts occurred only in the risperidone and olanzapine groups. Men responded better to treatment than women during the initial 2 hours (p = 0.046) as well as over the 5 day course (p < 0.001). No difference between drug groups was observed regarding diazepam or biperiden use. Oral haloperidol, risperidone, and olanzapine seem to be suitable for treating acute severe psychotic agitation in schizophrenia spectrum disorders. We observed a gender effect with poorer outcome in women.

Part 1. Chemical and Physical Restraints in the Management of Mechanically Ventilated Patients in the ICU: Contributing Factors

Chemical and physical restraints are frequently used in the intensive care unit (ICU) to control agitated patients and to prevent self-harm and unplanned extubations. Published work relating to the numerous issues of the care and treatment strategies for these patients remains conflicting and unclear. Literature regarding sedation and chemical restraint reveals a trend towards management with lighter sedation, use of sedation assessment tools and sedation protocols. It remains unclear which treatment is best for agitated and delirious patients, and the evidence on the effect of sedation is conflicting. A large portion of the literature on the use of physical restraint is from general hospital wards and residential homes, and not from the ICU environment. The purpose of this paper is to provide a summary of the existing literature on the use of physical and chemical restraints in the ICU setting. In Part 1 of this two-part paper, the evidence on chemical and physical restraints is explored with specific focus on definition of terms, unplanned

Can we predict agitation in patients with suicide attempts in the emergency department?

Background: The agitation in patients presenting to the emergency department (ED) after suicide attempts is common and an important problem. Objective: To establish whether we can predict agitated patients among suicide attempt patients in ED. Methods: This is a cross-sectional observational study of adult suicide attempt events in ED. Information was collected prospectively on a specially designed data-collection form. Patients aged 16 years old and above who presented to the ED for care due to suicide attempts were included in the study. Suicide attempts were grouped as aggressive and non-aggressive attempts. Results: A total of 533 patients were included. Forty-three of these patients had agitation in ED (8%). Non-aggressive suicide attempts were referred to psychiatry services more than aggressive ones (73.6%, n=345 vs 32.8%, n=21, P<0.0001). Agitation in ED and being male increased aggressive suicide attempt risk 3.5 (95% CI:1.6-7.6) and 3.2 times (95% CI:1.8-5.5), respectively. Agitation was statistically more frequent among these patients: those on antidepressant overdose, with previous suicide attempt; with aggressive suicide attempt; and those with confusion; and unconsciousness (P<0.05). Conclusion: Patients who attempted suicide and whose risk of harm to others included those with: antidepressant overdose, aggressive suicide attempt and the unconscious. Response teams should be prepared for these subgroups.

Incidência e fatores associados à contenção física em pacientes agitados e/ou agressivos em emergências psiquiátricas

Os pacientes agressivos e/ou agitados correspondem a 10% de todas as internações em emergências psiquiátricas. Dependendo do grau de agitação, esses pacientes representam um risco para a integridade física, tanto para os profissionais que ali estão como para si mesmos. Dentre as alternativas para lidar com esses casos está a contenção física. Ainda que amplamente utilizada, seu uso é controverso e proibido em alguns países. No Brasil inexistem protocolos orientando o seu uso. O objetivo deste estudo foi conhecer a freqüência e os fatores associados a esta prática através de uma revisão sistemática e de um estudo em emergências psiquiátricas do município do Rio de Janeiro. A revisão identificou apenas quatro estudos, sendo três nos EUA e um na Índia. A freqüência de contenção em pacientes agitados e/ou agressivos nos serviços de emergência psiquiátrica variou de 14% até 59%. Os desenhos adotados, assim como as análises estatísticas, mostraram fragilidades para a investigação dos fatores explicativos para o uso de contenção física. O estudo nas emergências psiquiátricas do Rio de Janeiro lançou mão de informações sobre o uso de contenção física entre 298 pacientes participantes de um ensaio clínico comparando dois medicamentos para lidar com quadros de agitação psicomotora e comportamento agressivo nesses serviços. As variáveis investigadas foram aquelas coletadas antes da entrada do paciente no ensaio clínico. Portanto, variáveis que antecederam a decisão do médico conter o paciente. A análise dos dados fez uso do método Bayesiano. As prioris dos parâmetros utilizadas no modelo de regressão binária foram obtidas de um outro ensaio clínico, conduzido em uma das três emergências envolvidas no presente estudo. A freqüência no emprego da contenção física foi 24,5%, sem diferença entre os três hospitais. O estudo mostrou ainda que pacientes mais jovens, com quadros mais intensos, com suspeita diagnóstica de entrada de abuso de substâncias e que foram atendidos na parte da manhã apresentaram maior chance de serem fisicamente contidos. O presente trabalho aponta para a necessidade de conduzir estudos especificamente desenhados para avaliar a freqüência e os fatores associados com o uso de contenção física, os quais deverão subsidiar o desenvolvimento de protocolos sobre o uso desta prática em nosso meio.

A comparison of the efficacy and safety of olanzapine versus haloperidol during transition from intramuscular to oral therapy

Background: Acutely agitated patients with schizophrenia who receive intramuscular (IM) medications typically are switched to oral (PO) antipsychotic maintenance therapy Objective: The goal of this study was to assess the efficacy and safety of olanzapine versus those of haloperidol during transition from IM to PO therapy We used additional data from a previously reported trial to test the hypothesis that the reduction in agitation achieved by IM olanzapine 10 mg or IM haloperidol 7.5 mg would be maintained following transition to 4 days of PO olanzapine or PO haloperidol (5-20 mg/d for both). We also hypothesized that olanzapine would maintain its more favorable extrapyramidal symptom (EPS) safety profile. Methods: This was a multinational (hospitals in 13 countries), double-blind, randomized, controlled trial. Acutely agitated inpatients with schizophrenia were treated with 1 to 3 IM injections of olanzapine 10 mg or haloperidol 7.5 mg over 24 hours and were entered into a 4-day PO treatment period with the same medication (5-20 mg/d for both). The primary efficacy measurement was reduction in agitation, as measured by the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) score. Adverse events and scores on EPS rating scales were assessed. Results: A total of 311 patients (204 men, 107 women; mean [SD] age, 38.2 [11.6] years) were enrolled (131, 126, and 54 patients in the olanzapine, haloperidol, and placebo groups, respectively). In all, 93.1% (122/131) of olanzapine-treated patients and 92.1% (116/126) of haloperidol-treated patients completed the IM period and entered the PO period; 85.5% (112/131) of olanzapine-treated patients and 84.1% (106/126) of haloperidol-treated patients completed the PO period. IM olanzapine and IM haloperidol effectively reduced agitation over 24 hours (mean [SD] PANSS-EC change, -7.1 [4.8] vs -6.7 [4.3], respectively). Reductions in agitation were sustained throughout the PO period with both study drugs (mean [SD] change from PO period baseline, -0.6 [4.8] vs -1.3 [4.4], respectively). During PO treatment, haloperidol-treated patients spontaneously reported significantly more acute dystonia than olanzapine-treated patients (4.3% [5/116] vs 0% [0/122], respectively; P = 0.026) and akathisia (5.2% [6/116] vs 0% [0/122], respectively; P = 0.013). Significantly more haloperidol-treated patients than olanzapine-treated patients met categorical criteria for treatment-emergent akathisia (18.5% [17/92] vs 6.5% [7/107], respectively; P = 0.015). Conclusions: In the acutely agitated patients with schizophrenia in this study, both IM olanzapine 10 mg and IM haloperidol 7.5 mg effectively reduced agitation over 24 hours. This alleviation of agitation was sustained following transition from IM therapy to 4 days of PO treatment (5-20 mg/d for both). During the 4 days of PO treatment, olanzapine-treated patients did not spontaneously report any incidences of acute dystonia, and olanzapine had a superior EPS safety profile to that of haloperidol. The combination of IM and PO olanzapine may help improve the treatment of acutely agitated patients with schizophrenia. Copyright (C) 2003 Excerpta Medica, Inc.

Detection of right-to-left Atrial communication using agitated saline contrast imaging : experience with 1162 patients and recommendations for echocardiography

Background: Right-to-left shunting via a patent foramen ovale (PFO) has a recognized association with embolic events in younger patients. The use of agitated saline contrast imaging (ASCi) for detecting atrial shunting is well documented, however optimal technique is not well described. The purpose of this study is to assess the efficacy and safety of ASCi via TTE for assessment of right-to-left atrial communication in a large cohort of patients. Method: A retrospective review was undertaken of 1162 consecutive transthoracic (TTE) ASCi studies, of which 195 had also undergone clinically indicated transesophageal (TEE) echo. ASCi shunt results were compared with color flow imaging (CFI) and the role of provocative maneuvers (PM) assessed. Results: 403 TTE studies (35%) had paradoxical shunting seen during ASCi. Of these, 48% were positive with PM only. There was strong agreement between TTE ASCi and reported TEE findings (99% sensitivity, 85% specificity), with six false positive and two false negative results. In hindsight, the latter were likely due to suboptimal right atrial opacification, and the former due to transpulmonary shunting. TTE CFI was found to be insensitive (22%) for the detection of a PFO compared with TTE ASCi. Conclusions: TTE ASCi is minimally invasive and highly accurate for the detection of right-to-left atrial communication when PM are used. TTE CFI was found to be insensitive for PFO screening. It is recommended that TTE ASCi should be considered the initial diagnostic tool for the detection of PFO in clinical practice. A dedicated protocol should be followed to ensure adequate agitated saline contrast delivery and performance of provocative maneuvers.

The Scored Patient-Generated Subjective Global Assessment (PG-SGA) and its Association with Quality of Life in Ambulatory Patients Receiving Radiotherapy

OBJECTIVE: To evaluate the scored Patient-generated Subjective Global Assessment (PG-SGA) tool as an outcome measure in clinical nutrition practice and determine its association with quality of life (QoL). DESIGN: A prospective 4 week study assessing the nutritional status and QoL of ambulatory patients receiving radiation therapy to the head, neck, rectal or abdominal area. SETTING: Australian radiation oncology facilities. SUBJECTS: Sixty cancer patients aged 24-85 y. INTERVENTION: Scored PG-SGA questionnaire, subjective global assessment (SGA), QoL (EORTC QLQ-C30 version 3). RESULTS: According to SGA, 65.0% (39) of subjects were well-nourished, 28.3% (17) moderately or suspected of being malnourished and 6.7% (4) severely malnourished. PG-SGA score and global QoL were correlated (r=-0.66, P<0.001) at baseline. There was a decrease in nutritional status according to PG-SGA score (P<0.001) and SGA (P<0.001); and a decrease in global QoL (P<0.001) after 4 weeks of radiotherapy. There was a linear trend for change in PG-SGA score (P<0.001) and change in global QoL (P=0.003) between those patients who improved (5%) maintained (56.7%) or deteriorated (33.3%) in nutritional status according to SGA. There was a correlation between change in PG-SGA score and change in QoL after 4 weeks of radiotherapy (r=-0.55, P<0.001). Regression analysis determined that 26% of the variation of change in QoL was explained by change in PG-SGA (P=0.001). CONCLUSION: The scored PG-SGA is a nutrition assessment tool that identifies malnutrition in ambulatory oncology patients receiving radiotherapy and can be used to predict the magnitude of change in QoL.