Drug utilization research in Peru: Is real-world data available?

Background: Drug utilization research (DUR) is used to provide evidence-based data to inform policies and make decisions. The aim of this study was to map and describe available data sources for drug utilization research in Peru. Methods: We performed a search of data sources providing information on medication use on the website of governmental organizations. We also conducted a literature review using PubMed, LILACs, and BVS. Independently, researchers screened eligible data sources. Data characterization included accessibility, coverage data provider, type of data sources, and setting. We performed a descriptive analysis. Results: We identified seven data sources, CENAFyT, ICI, IDI (SISMED), and ENSUSALUD from MINSA, and CRI-ESSALUD, SGSS/ESSI, and ENSSA from ESSALUD. These presented information on adverse drug reactions (n = 2), drug consumption, and distribution (n = 2), prescription and drug dispensing (n = 1), and surveys addressed to medication users (n = 2). ENSUSALUD was the only data source publicly available. VIGIFLOW and ENSUSALUD have a national granularity from the public and private sectors. The setting of the data sources was both hospital and ambulatory care. Two data sources have individual-level data on adverse drug reactions and one on prescriptions. Four studies on drug utilization research in Peru were derived from ENSUSALUD. Conclusion: In Peru, few data sources are available for drug utilization research. There is an increased need to monitor medications for decision-making purposes. Local and international initiatives and partnerships of the government with academic institutions and the private sector might be a good strategy to increase the transparency of health data and for supporting decision-making using drug utilization research.

Resident and nurse reports of potential adverse drug reactions.

PURPOSE: Nursing home residents are at high risk for adverse drug reactions (ADR). To improve pharmacotherapeutic care for individual residents, healthcare professionals need to be aware of ADRs. In nursing homes, nurses have a central role in monitoring residents' health and informing physicians on the presence of ADRs. The aim of this study was to evaluate the value of nursing home residents' ADR reports. METHODS: Residents of a convenient sample of two nursing homes were included if their mental status and understanding of Dutch enabled them to report ADRs. In a cross-sectional design, residents and nurses were questioned about 17 potential ADRs. Reports of residents and nurses were consequently compared. Medication use was studied to describe the risk for ADRs per resident. RESULTS: Residents had a mean of eight different chronic medication prescriptions. Over 90% of the residents used medications which increase the risk of feeling somnolent/tired/sedated, arrhythmias and abdominal pain. The median number of potential ADRs reported by nurses was significantly lower compared to the number of resident reports (median [range], respectively, 1 [1-10] and 4 [1-10]). In general, residents reported the presence of more ADRs than nurses, except for confusion. The correspondence between nurse and resident reports ranged from 43% (dry mouth) till 88% (arrhythmia). CONCLUSIONS: Nurses and patients reported a lot of potential ADRs. The type of ADRs they reported was different and complementary. Questioning residents about specific potential ADRs may increase the awareness of ADRs.

Prevalence and management of antibiotic associated diarrhea in general hospitals.

BACKGROUND: Antibiotic-associated diarrhea (AAD) is a common adverse effect of antibiotic (AB) treatment. This study aimed to measure the overall prevalence of AAD (including mild to moderate diarrhea) in hospitalized AB treated patients, to investigate associated risk factors and to document AAD associated diagnostic investigations, contamination control and treatment. METHODS: During 8 observation days (with time delay of 10-14 days between each observation day), all adult patients hospitalized at an internal medicine ward of 4 Belgian participating hospitals were screened for AB use. Patients receiving AB on the observation day were included in the study and screened for signs and symptoms of AAD using a period prevalence methodology. Clinical data were collected for all AB users and AAD related investigations and treatment were collected for the entire duration of AAD. Additionally, nurses noted daily the frequency of all extra care associated to the treatment of the diarrhea. RESULTS: A total of 2543 hospitalized patients were screened of which 743 were treated with AB (29.2%). Included AB users had a mean age of 68 yr (range 16-99) and 52% were male. Penicillins were mostly used (63%) and 19% received more than one AB. AAD was observed in 9.6% of AB users including 4 with confirmed Clostridium difficile infection. AAD started between 1 and 16 days after AB start (median 5) and had a duration of 2 to 41 days (median 4). AAD was significantly associated with higher age and the use of double AB and proton pump inhibitors. AAD patients had extra laboratory investigations (79%), received extra pharmacological treatment (42%) and 10 of them were isolated (14%). AAD related extra nursing time amounted to 51 minutes per day for the treatment of diarrhea. CONCLUSIONS: In this observational study, with one third of hospitalized patients receiving AB, an AAD period prevalence of 9.6% in AB users was found. AAD caused extra investigations and treatment and an estimated extra nursing care of almost one hour per day. Preventive action are highly recommended to reduce the prevalence of AAD and associated health care costs.

The impact of chronic benzodiazepine use on cognitive evolution in nursing home residents.

OBJECTIVE: Chronic use of benzodiazepines and Z-drugs (BZD/Zs) has been linked to cognitive decline. In this one-year prospective cohort study, we explored the impact of chronic BZD/Z use on cognitive decline compared to nonusers. METHODS: In cognitively capable BZD/Z users and nonusers in 10 Belgian nursing homes, we investigated cognition with the MiniMentalStateExamination(MMSE) at baseline and one year. A decrease of ≥ 4 points on the MMSE (clinically relevant decrease) was used in multiple logistic regression. We collected baseline demographics, functional, psychometric and social characteristics potentially influencing cognition. RESULTS: In both the 131 BZD/Z users and 95 nonusers, the cognition decreased significantly over time, but without significant difference between the groups. Clinically relevant decrease was present in 34% BZD/Z users and 27% nonusers (NS). Controlled for age, gender, education and BZD/Z use, the significant risk factors for clinically relevant cognitive decline were depression, hearing and functional impairment. Frequent reading was associated with less MMSE decrease. Our findings could not demonstrate with statistical significance that BZD/Z use was associated with fast cognitive decline. The risk factors for fast decline were depression, hearing and functional impairment, and the absence of a reading attitude. In addition, BZD/Z use and depression were associated, indicating a complex relationship.

Assessment of acceptability and usability of new delivery prototype device for intradermal vaccination in healthy subjects.

The objectives of this study were to assess the acceptability and usability of a newly developed intradermal prototype device, VAX-ID™, in healthy subjects. In April 2012 an investigational study was conducted in healthy subjects aged 18 to 65 y. To compare injection site and route of administration, subjects were allocated to 4 subgroups, either receiving subsequently 2 intradermal (ID) injections (one in the forearm and one in the deltoid) or an ID (forearm) and an intramuscular (IM) (deltoid) injection. All injections contained saline solution. Acceptability was assessed with a subjects' questionnaire and a daily electronic diary for 5 d. Usability was assessed with a vaccinators' questionnaire and an expert panel. A 10-point Visual Analog Scale was used to score several statements on usability and acceptability. A total of 102 healthy subjects were enrolled in the study (age: 19-63). No statistically significant differences were seen in demographic characteristics between the ID and IM groups. Anxiety before injection, pain during injection and duration of injection were rated significantly lower for ID compared to IM. One day after the injections, redness was reported more often after ID injection in the forearm versus ID in the deltoid; pain at injection site was reported significantly more often after IM vs. ID injection. The new VAX-ID prototype device was found easy to handle, easy to use and safe. The new VAX-ID prototype device was shown to have a high degree of acceptability as well as usability. Further studies with VAX-ID will be conducted using vaccine antigen allowing assessment of immunogenicity and safety. Additionally, these studies will help to further improve VAX-ID in terms of accuracy of delivered dose and feedback to the vaccinator. (NCT01963338).

Feasibility of discontinuing chronic benzodiazepine use in nursing home residents: a pilot study.

PURPOSE: Guidelines discourage chronic benzodiazepines and related Z drugs (BZD/Zs) for sleep problems. However, prevalence among nursing home residents remains high. Discontinuing these drugs is widely recommended but seems difficult to implement. The aim of our study was to evaluate the overall feasibility in the nursing home, in terms of willingness towards discontinuation and success rate at 8 months, together with the impact on withdrawal symptoms, change in sleep quality, quality of life and medication use. METHODS: In a convenience sample of five nursing homes (823 residents), we included cognitively competent residents with chronic BZD/Z use for insomnia. We investigated sleep quality [with Pittsburgh Sleep Quality Index (PSQI)], quality of life (EQ-5D) and withdrawal symptoms [Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ)]. Success rate was analysed with survival analysis. RESULTS: Of the 135 eligible residents, both general physician (GP) and resident were willing to initiate discontinuation in 38 residents. Reasons for refusing to initiate discontinuation among GPs was the unmotivated patient and among residents the reluctance towards change. At 8 months, 66.0% were successful discontinuers, with the subjective PSQI component evolving favourably (p = 0.013) and a decreasing number of midnight awakenings (p = 0.041). In the relapse group (n = 13), the quality of life decreased (p = 0.012), with mainly an increase of problems with activities and pain/discomfort. In both groups, the withdrawal symptoms, functionality and medication use did not change. CONCLUSION: Discontinuation of chronic BZD/Z use is feasible in the nursing home setting without noticeable withdrawal symptoms, without a switch in medication use, without detrimental effect on quality of life and with a positive effect on the self-perceived sleep quality.

One-year evolution of sleep quality in older users of benzodiazepines: a longitudinal cohort study in belgian nursing home residents.

OBJECTIVES: Chronic use of benzodiazepines and z-drugs (BZD/Zs), the most commonly used symptomatic treatment for sleep problems, is discouraged because of the unproven long-term effectiveness. In this study, we evaluated 1-year evolution of subjective sleep quality of chronic BZD/Z users compared with nonusers. METHODS: All cognitively competent residents from ten Belgian nursing homes were screened and compiled in a group of chronic BZD/Z users or nonusers, based on the medication chart. We collected demographic, functional and psychometric characteristics (depressive symptoms with the 8-item Geriatric Depression Scale), sleep parameters (with the Pittsburgh Sleep Quality Index-PSQI) and medication use. We analysed evolution of sleep quality with nonparametric statistics. Associations with worsening of sleep quality were analysed with linear regression. RESULTS: We collected data of 131 BZD/Z users and 95 nonusers. The mean age in both groups was 85 years and 77 % was female. Over a period of 1 year, the PSQI score evolved from 5.2 to 5.8 (p = 0.035) in the BZD/Z users, and from 4.3 to 4.7 (p = 0.078) in the nonusers. Though the mean deterioration in 1 year did not differ significantly between both groups, the BZD/Z users had a significantly worse sleep quality compared with nonusers at both time points. Depressive symptoms were significantly associated with worsening sleep quality (ß = -0.243, p < 0.001). CONCLUSION: Sleep quality in chronic BZD/Z users significantly decreased over 1 year and was significantly worse than in nonusers at the end of this period. This study suggests that using BZD/Zs chronically does not maintain or improve sleep quality. Depressive symptoms are an important factor in the deterioration of sleep quality.

Sharps injuries amongst healthcare workers: review of incidence, transmissions and costs.

BACKGROUND: Sharps injuries and the related risk of infections such as hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) represent one of the major occupational health risks for healthcare workers (HCWs). LITERATURE REVIEW: An overview of available data on the incidence of sharps injuries and the related HBV, HCV and HIV infections and ensuing costs is provided. RESULTS: Literature reported incidence rates of sharps injuries ranging from 1.4 to 9.5 per 100 HCWs, resulting in a weighted mean of 3.7/100 HCWs per year. Sharps injuries were associated with infective disease transmissions from patients to HCWs resulting in 0.42 HBV infections, 0.05-1.30 HCV infections and 0.04-0.32 HIV infections per 100 sharps injuries per year. The related societal costs had a mean of €272, amounting to a mean of €1,966 if the source patient was HIV positive with HBV and HCV co-infections. CONCLUSION: Sharps injuries remain a frequent threat amongst HCWs. The follow-up and treatment of sharps injuries and the deriving consequences represent a significant cost factor.

Adherence to phosphate binders in hemodialysis patients: prevalence and determinants.

BACKGROUND: Phosphate control is a crucial treatment goal in end-stage renal disease, but poor patient adherence to phosphate binder therapy remains a challenge. This study aimed to estimate the extent of phosphate binder adherence in hemodialysis patients and to identify potential determinants. METHODS: Phosphate binder adherence was measured blindly in 135 hemodialysis patients for 2 months using the medication event monitoring system. Patient data, gathered at inclusion through medical records, ad hoc questionnaires and the short form (SF)-36 health survey, included: (1) demographics, (2) perceived side-effects, belief in benefit, self-reported adherence to the therapy, (3) knowledge about phosphate binder therapy, (4) social support, and (5) quality of life (SF-36). Phosphatemia data was collected from charts. 'Being adherent' was defined as missing <1 total daily dose/week and 'being totally adherent' as missing <1 total daily dose/week, every week. RESULTS: Mean age of patients was 67 years and 64 % of the sample was male. Over the 2 months, 78 % of the prescribed doses were taken. Every week, about half of patients were adherent. Over the entire 8-week period, 22 % of patients were totally adherent. Mean phosphatemia levels were 0.55 mg/dl lower in adherent than nonadherent patients (4.76 vs. 5.31 mg/dl). Determinants for being totally adherent were living with a partner, higher social support (both were interrelated) and higher physical quality of life. Experiencing intake-related inconvenience negatively affected adherence. The social support and quality of life physical score explained 26 % of the variance in adherence. CONCLUSIONS: Phosphate binder nonadherence remains a major problem. Interventions should aim, at least, to improve social support. With few associated factors found and yet low adherence, an individualized approach seems indicated.

Barriers to antipsychotic discontinuation in nursing homes: an exploratory study.

OBJECTIVES: Despite safety warnings on serious adverse effects and guidance advising discontinuation, antipsychotic use in nursing homes remains high. Studies documenting the barriers experienced to antipsychotic discontinuation are rare. This exploratory study investigates the willingness of nurses and general practitioners (GPs) as well as the barriers to undertake antipsychotic discontinuation. DESIGN AND SETTING: A mixed-method study involving an expert meeting, followed by a survey using structured questionnaires distributed to responsible nurses (primary caregivers) and treating GPs on selected nursing home residents in Belgian nursing homes to generate case-specific information. RESULTS: Antipsychotic users (n = 113) had a mean age of 81 years (range 57-97); 62% were female and 81% had moderate to severe cognitive impairment. Nurses and GPs indicated a willingness for antipsychotic discontinuation in a small proportion of residents, 13.8% and 12.2%, respectively, with a shared willingness in only 4.2%. Residents for whom there was a higher willingness to try antipsychotic discontinuation were generally older (mean age 84.6 vs. 80.3, p = 0.07), had high physical dependency (ADL > 14, 93.3% vs. 60.9%, p = 0.01) and resided on a ward with controlled access (80.0% vs. 45.7%, p = 0.02). In contrast, residents for whom there was a significant lower willingness for discontinuation already had a previously failed discontinuation effort, and may present risk of harm to themselves or to others. Nurses working longer on the ward, with lower education, presented higher barriers to discontinuation of antipsychotics. CONCLUSION: Nurses and GPs share a very low willingness and high barriers to antipsychotic discontinuation. To implement discontinuation programs, complex multidisciplinary interventions should be offered taking existing barriers into account.

Quality of prescribing in Belgian nursing homes: an electronic assessment of the medication chart.

OBJECTIVE: To develop a computerized assessment tool for monitoring the quality of prescribing in Belgian nursing homes. DESIGN: In a observational cross-sectional study of the medication charts of nursing home residents, potentially inappropriate medication (PIM) was investigated using three scoring systems for the elderly (Beers, ACOVE, BEDNURS) complemented with a list of drug-drug interactions. SETTING: A representative stratified sample of Belgian nursing homes (n = 76). PARTICIPANTS: A random sample of nursing home residents with a complete data set (n = 1730) excluding palliative care patients. MAIN OUTCOME MEASURE: A combination of PIM scores to assess inappropriate, under- and overprescribing. RESULTS: Included residents had a mean age of 85, 78% were female. They used a mean of 7.1 chronic medications. Most PIMs were detected by the application of the ACOVE criteria for underprescribing with 58% of patients having at least one PIM. Using the BEDNURS and the Beers criteria, at least one PIM was noticed in 56 and 27% of patients, respectively. Patients' characteristics showing a positive relationship with the PIM score were age, female gender, amount of clinical and nursing care problems, number of prescriptions and the use of psychotropic drugs (multiple regression analysis R(2) = 0.332). CONCLUSIONS: In Belgian nursing homes, the observed high level of drug utilization was associated with potentially inappropriate prescribing. The development of a combined assessment tool and the implementation of a computerized monitoring system of PIMs is highly recommended to improve the quality of prescribing.

Sleep quality of benzodiazepine users in nursing homes: a comparative study with nonusers.

OBJECTIVES: We aim to describe subjective sleep quality among long-term users of benzodiazepines (BZDs) in Belgian nursing homes, to compare it to nonusers, and to investigate determinants of poor sleep quality. METHODS: All mentally competent residents from 10 nursing homes were screened and compiled in a group of long-term BZD users or in a group of nonusers based on the medication chart. We collected demographic, functional, and medication characteristics and global and specific sleep parameters using the Pittsburgh Sleep Quality Index (PSQI). Linear regression was used to investigate which parameters were associated with sleep quality. RESULTS: Of the 300 residents, 178 (59%) were long-term BZD users and 122 were nonusers. The 2 groups did not differ in demographic and functional characteristics (mean age, 85.5 y; range, 57-100; 75% women). The users reported significantly more difficulties with falling asleep, had more midnight awakenings, felt less rested in the morning, and had a poorer self-perceived sleep quality compared to nonusers. Sleep duration and time to fall asleep did not differ. The self-perceived sleep quality was mainly determined by difficulties during initiation of sleep. After controlling for demographic, medication, and functional characteristics, BZD use remained strongly associated with poor sleep (r=0.173; P=.003), and a study centre effect (differences among nursing homes) was observed (r=0.229; P<.001). CONCLUSION: Our findings do not support long-term effectiveness of BZDs; long-term users slept more poorly than nonusers and were even more outspoken in users of long-acting BZDs. In future longitudinal comparative studies of sleep quality, unexplained variability needs further assessment with medical, psychologic, and institutional parameters.

The development and test of an intervention to improve ADR screening in nursing homes.

OBJECTIVES: The aim of this study was to develop and test the effect of an instrument, Pharmanurse, to facilitate nurse-driven adverse drug reaction (ADR) screening as an input for interdisciplinary medication review in nursing homes. DESIGN: Intervention study with a pre-posttest design PARTICIPANTS: All residents of a convenience sample of 8 nursing homes of more than 80 beds were eligible if they resided at least 1 month in the nursing home and took 4 or more different medications. Residents receiving palliative care were excluded. INTERVENTION: The intervention consisted of interdisciplinary medication review, prepared by nurse observations of potential ADRs using personalized screening lists generated by the Pharmanurse software. Pharmanurse is specifically adapted to use by nurses and to use in nursing homes. MEASUREMENTS: Outcome parameters were the number of ADRs detected by nurses, ADRs confirmed by general practitioners, and medication changes. After the intervention, health care professionals involved completed a questionnaire to evaluate the value and the feasibility of the intervention. RESULTS: Nurses observed 1527 potential ADRs in 81% of the 418 residents (mean per resident 3.7). Physicians confirmed 821 ADRs in 60% of the residents (mean per resident 2.0). As a result, 214 medication changes were planned in 21% of the residents (mean per resident 0.5) because of ADRs. Health care professionals gave the Pharmanurse intervention a score of 7 of 10 for the potential to improve pharmacotherapy and 83% of the physicians were satisfied about nurses' screening for ADRs. CONCLUSIONS: The Pharmanurse intervention supports nurses in ADR screening and may have the potential to improve pharmacotherapy.

Nurse-led interventions to enhance adherence to chronic medication: systematic review and meta-analysis of randomised controlled trials.

PURPOSE: Non-adherence to chronic medication remains an important problem with vast consequences and without solutions to date. Nurses are well positioned to provide adherence care, yet currently represent an underutilised force in improving adherence and outcomes. This review aims to synthesise the effect of nurse-led interventions on adherence to chronic medication. METHODS: Using Review Manager software, a meta-analysis was conducted. The search term medication adherence was combined with random* and nurse in PubMed and ISI Web of Knowledge. Retrieved articles' reference lists were hand searched. Included were randomised controlled trials on nurse-led interventions, aiming to improve chronic medication adherence. Articles were to be in English and published from 2006 to 2011. Quality was assessed using an adapted version of the CONSORT tool. RESULTS: Ten studies met the selection criteria, seven of which were on HIV-positive patients. Their quality was acceptable to high. Counselling was the intervention most frequently assessed, mostly given face-to-face, but also in groups and via electronic messages. All interventions enhanced adherence. Of the five studies reporting adherence as mean percentage of adherence, pooled mean differences were +5.39 (1.70-9.07) (short term) and +9.49 (4.68-14.30) (long term), favouring the intervention groups. Of the studies reporting adherence dichotomously, odd's ratios were 1.55 (1.04-2.29) (short term) and 1.87 (1.35-2.61) (long term). The longer counselling was effectuated, the better the results. CONCLUSIONS: Counselling appears to be an effective approach that nurses can use to supplement other methods, building a multifaceted strategy to enhance adherence. Tackling non-adherence seems to demand continuous efforts and follow-up.

Economic evaluation of different treatment modalities in acute kidney injury.

BACKGROUND: Major controversy exists regarding the preferred treatment option for acute kidney injury (AKI). The purpose of this study was to assess the incremental cost-effectiveness of continuous renal replacement therapy (CRRT) versus intermittent renal replacement therapy (IRRT) and conservative (CONS) AKI treatment in Belgium. METHODS: An area-under-the-curve model based on survival analysis was used to estimate costs and health outcomes using a 2-year time horizon. Input data were derived from the multi-centre Stuivenberg Hospital Acute Renal Failure 4 study. RESULTS: Analyses indicated that in-hospital mortality, hospitalization costs and hospital length of stay differed significantly between treatment modes. Follow-up mortality rates and follow-up cost per day showed no significant difference between the treatment modes. Utility values, which improved gradually after admission to the hospital, revealed no significant differences between the three treatment strategies. CONS treatment was associated with a 2-year cost of 33,802€ and 0.54 quality-adjusted life years (QALYs). The CRRT was the most expensive therapy with a cost of 51,365€ leading to 0.57 QALYs. The cost and QALYs associated with IRRT were 43,445€ and 0.50, respectively. One-way sensitivity analyses indicated the 'in-hospital mortality' as the variable with the greatest influence on the results. Probabilistic sensitivity analysis resulted in a significant difference in treatment costs but no significant difference in QALY gain. CONCLUSIONS: This study has indicated that the most expensive treatment (CRRT) associated with an incremental cost of approximately €7920 generates only a minor non-significant increase in QALYs of 0.07 compared with IRRT. Additionally, the results revealed that the RRTs did not result in a significant increase in QALYs despite their higher cost compared with the CONS treatment. From a health economic perspective, the latter seems to be the preferred treatment strategy.

The use of antidepressants in Belgian nursing homes: focus on indications and dosages in the PHEBE study.

BACKGROUND: Since antidepressants are prescribed for multiple indications, the use of an antidepressant cannot be equated with a diagnosis of depression. OBJECTIVE: The objective of this study was to examine the quality of antidepressant prescribing in Belgian nursing homes, with a critical evaluation of indications and dosages, to see whether depression was appropriately treated in terms of drug choice, the indications for which antidepressants were being prescribed and whether there was underdosing. METHODS: This analysis was based on data obtained in the Prescribing in Homes for the Elderly in Belgium (PHEBE) study, a cross-sectional, descriptive study of a representative, stratified, random sample of 1,730 residents from 76 Belgian nursing homes. The PHEBE study investigated overall drug utilization in Belgian nursing homes in 2006. Clinical and medication data for the present study were obtained from this study. A 28-item checklist of clinical conditions was designed ad hoc for the PHEBE study and sent to the residents' general practitioners (GPs) to collect clinical information. We copied the residents' medication charts, classified the drugs using the Anatomical Therapeutic Chemical (ATC) classification system codes and transferred the drug names and dosages into a database. Information on indications was retrospectively obtained from the GPs, so that we could link the indication to each medication. Minimum effective doses (MEDs) of antidepressants to treat major depression were obtained from the literature to assess underdosing. RESULTS: The overall use of antidepressants in nursing homes was 39.5 % (95 % CI 37.2, 41.8). The physicians classified 34.2 % (95 % CI 32.0, 36.4) of the residents as having depression, and 80.9 % of these patients were treated with an antidepressant. Indications among the single antidepressant users (n = 551) were depression (66.2 %), insomnia (13.4 %), anxiety (6.2 %) and neuropathic pain (1.6 %). In the indication of depression, 74.8 % used a selective serotonin reuptake inhibitor (SSRI), predominantly citalopram, sertraline and escitalopram. Venlafaxine was used by 10.7 % of the residents. Dosages for these antidepressants were equal to or higher than the MED. But when trazodone, amitriptyline or mirtazapine were used to treat depression, respectively, 92.3, 55.5 and 44.5 % of prescribed dosages were below the MED. In the indication of insomnia, most of the time, trazodone (90.5 %) or mirtazapine (5.4 %) were used, and in lower dosages than those required for depression treatment (

The effect of earplugs during the night on the onset of delirium and sleep perception: a randomized controlled trial in intensive care patients.

INTRODUCTION: This study hypothesised that a reduction of sound during the night using earplugs could be beneficial in the prevention of intensive care delirium. Two research questions were formulated. First, does the use of earplugs during the night reduce the onset of delirium or confusion in the ICU? Second, does the use of earplugs during the night improve the quality of sleep in the ICU? METHODS: A randomized clinical trial included adult intensive care patients in an intervention group of 69 patients sleeping with earplugs during the night and a control group of 67 patients sleeping without earplugs during the night. The researchers were blinded during data collection. Assignment was performed by an independent nurse researcher using a computer program. Eligible patients had an expected length of stay in the ICU of more than 24 hours, were Dutch- or English-speaking and scored a minimum Glasgow Coma Scale of 10. Delirium was assessed using the validated NEECHAM scale, sleep perception was reported by the patient in response to five questions. RESULTS: The use of earplugs during the night lowered the incidence of confusion in the studied intensive care patients. A vast improvement was shown by a Hazard Ratio of 0.47 (95% confidence interval (CI) 0.27 to 0.82). Also, patients sleeping with earplugs developed confusion later than the patients sleeping without earplugs. After the first night in the ICU, patients sleeping with earplugs reported a better sleep perception. CONCLUSIONS: Earplugs may be a useful instrument in the prevention of confusion or delirium. The beneficial effects seem to be strongest within 48 hours after admission. The relation between sleep, sound and delirium, however, needs further research. TRIAL REGISTRATION: Current Controlled Trials ISRCTN36198138.

Systematic appraisal of dementia guidelines for the management of behavioural and psychological symptoms.

BACKGROUND: Within the treatment of dementia, management of behavioural and psychological symptoms (BPSD) is a complex component. PURPOSE: We wanted to offer a pragmatic synthesis of existing specific practice recommendations for managing BPSD, based on agreement among systematically appraised dementia guidelines. DATA SOURCES: We conducted a systematic search in MEDLINE and guideline organisation databases, supplemented by a hand search of web sites. STUDY SELECTION: Fifteen retrieved guidelines were eligible for quality appraisal by the Appraisal of Guidelines Research and Evaluation instrument (AGREE), performed by 2 independent reviewers. DATA EXTRACTION: From the 5 included guidelines, 18 specific practice recommendations for BPSD were extracted and compared for their level of evidence and strength. DATA SYNTHESIS: No agreement was found among dementia guidelines for the majority of specific practice recommendations with regard to non-pharmacological interventions, although these were recommended as first-line treatment. Pharmacological specific practice recommendations were proposed as second-line treatment, with agreement for the use of a selection of antipsychotics based on strong supporting evidence, but with guidance for timely discontinuation. LIMITATIONS: The appraisal of the level of agreement between guidelines for each specific practice recommendation was complicated by variation in grading systems, and was performed with criteria developed a posteriori. CONCLUSION: Despite the limited number of recommendations for which agreement was found, guidelines did agree on careful antipsychotic use for BPSD. Adverse events might outweigh the supporting evidence of efficacy, weakening the recommendation. More pivotal trials on the effectiveness of non-pharmacological interventions, as well as guidelines specifically focusing on BPSD, are needed.