The expert consensus guideline series. Treatment of behavioral emergencies 2005. European Psychiatric Association (EPA) guidance on forensic psychiatry: Evidence based assessment and treatment of mentally disordered offenders. The expert consensus guideline series. Treatment of dementia and its behavioral disturbances. Introduction: methods, commentary, and summary. Treatment of Behavioral Emergencies: A Summary of the Expert Consensus Guidelines Oral risperidone with lorazepam versus oral zuclopenthixol with lorazepam in the treatment of acute psychosis in emergency psychiatry: a prospective, comparative, open-label study Are Low Doses of Antipsychotics Effective in the Management of Psychomotor Agitation? A Randomized, Rated-Blind Trial of 4 Intramuscular Interventions Medication development for agitation and aggression in Alzheimer disease: review and discussion of recent randomized clinical trial design. The case for practical clinical trials in psychiatry. Intramuscular Ziprasidone Versus Haloperidol for Managing Agitation in Chinese Patients With Schizophrenia Risk assessment and shared care planning in out-patient forensic psychiatry: cluster randomised controlled trial. Efficacy of Topiramate, Valproate, and Their Combination on Aggression/Agitation Behavior in Patients With Psychosis An investigation of long-term effects of group music therapy on agitation levels of people with Alzheimer's Disease Does psychomotor agitation in major depressive episodes indicate bipolarity? Consensus Recommendations for the Clinical Application of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Depression. 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No Long-Term Effect of Behavioral Treatment on Psychotropic Drug Use for Agitation in Alzheimer's Disease Patients Drugs in aggressive behavior. The role of cardiac registries in evidence-based medicine. The Psychiatric Emergency Research Collaboration-01: methods and results. World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for the Pharmacological Treatment of Anxiety, Obsessive-Compulsive and Post-Traumatic Stress Disorders – First Revision British consensus guidelines on intravenous fluid therapy for adult surgical patients (GIFTASUP) – Cassandra’s view World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for Biological Treatment of Schizophrenia, Part 1: Acute treatment of schizophrenia The expert consensus guideline series. Pharmacotherapy of depressive disorders in older patients. Psychomotor agitation in major depressive disorder is a predictive factor of mood-switching. 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Introduction: methods, commentary, and summary. Effectiveness of a CBT Intervention for Persistent Insomnia and Hypnotic Dependency in an Outpatient Psychiatry Clinic. The value of specialist clinical assessment of older people prior to entry to care homes. Nonpharmacological therapeutic techniques to decrease agitation in geriatric psychiatric patients with dementia. Hypofractionated Radiation Therapy for Localized Prostate Cancer: Executive Summary of an ASTRO, ASCO, and AUA Evidence-Based Guideline. Many more reasons behind difficulties in recruiting patients to randomized controlled trials in psychiatry. The role of endoscopy in the management of acute non-variceal upper GI bleeding. Rapid tranquillisation of violent or agitated patients in a psychiatric emergency setting. Pragmatic randomised trial of intramuscular lorazepam v. haloperidol plus promethazine. Rapid tranquilization for agitated patients in emergency psychiatric rooms: a randomized trial of olanzapine, ziprasidone, haloperidol plus promethazine, haloperidol plus midazolam and haloperidol alone. Pharmacist-Led Medication Reviews to Identify and Collaboratively Resolve Drug-Related Problems in Psychiatry – A Controlled, Clinical Trial 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation Effects of dexmedetomidine on delirium duration of non-intubated ICU patients (4D trial): study protocol for a randomized trial Suicide in a large population of former psychiatric inpatients. Citalopram: Clinical effect profile in comparison with clomipramine. A controlled multicenter study Withdrawal of haloperidol, thioridazine, and lorazepam in the nursing home: a controlled, double-blind study. 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Efficacy of an adjunctive brief psychodynamic psychotherapy to usual inpatient treatment of depression: rationale and design of a randomized controlled trial The Effects of Snoezelen (Multi-Sensory Behavior Therapy) and Psychiatric Care on Agitation, Apathy, and Activities of Daily Living in Dementia Patients on a Short Term Geriatric Psychiatric Inpatient Unit Intramuscular aripiprazole in the acute management of psychomotor agitation. Quality assessment of observational studies in psychiatry: an example from perinatal psychiatric research Effectiveness of geriatric psychiatry consultation in an acute care hospital: a randomized clinical trial. An Evaluation of the Effectiveness of a Consultation-Iiaison Psychiatry Service in General Practice
OBJECTIVES Due to inherent dangers and barriers to research in emergency setting s , few data are available to guide clinicians about how best to manage behavioral emergencies . Key constructs such as agitation are poorly defined . This lack of empirical data led us to undertake a survey of expert opinion , results of which were published in the 2001 Expert Consensus Guidelines on the Treatment of Behavioral Emergencies . Several second-generation ( atypical ) antipsychotics ( SGAs ) are now available in new formulations for treating behavioral emergencies ( e.g. , intramuscular [ i.m . ] olanzapine and ziprasidone ; rapidly dissolving tablets of olanzapine and risperidone ) . Critical questions face the field . The SGAs are significantly different from the FGAs and from each other and have not been studied in unselected patients as were the FGAs . Can the SGAs can be thought of as a class , do all antipsychotics have similar anti-agitation effects in different conditions , and , if equally effective , what limits might their safety profiles impose ? Should antipsychotics be used more specifically to treat psychotic conditions , while benzodiazepines ( BNZs ) alone are used nonspecifically ? Few data are available concerning combinations of SGAs and BNZs , and findings concerning the traditional combination of haloperidol plus a BNZ may not be relevant to combinations with SGAs . The culture is also evolving with more emphasis on patient involvement in treatment decisions . An international consensus has been developing that calming rather than sedation is the appropriate endpoint of behavioral emergency interventions . We undertook a new survey of expert opinion to up date recommendations from the earlier survey . METHOD A written survey of 61 questions ( 1,020 options ) was mailed to 50 experts in the field , 48 ( 96 % ) of whom completed it . The survey sought to define level of agitation at which emergency interventions are appropriate , scope of assessment depending on urgency and patients ' ability to cooperate , guiding principles for selecting interventions , and appropriate physical and medication strategies at different levels of diagnostic confidence for a variety of provisional diagnoses and complicating conditions . A modified version of the R AND Corporation 's 9-point scale for rating appropriateness of medical decisions was used to score most options . Consensus was defined as a non-r and om distribution of scores by chi-square " goodness-of-fit " test . We assigned a categorical rank ( first line/preferred , second line/alternate , third line/usually inappropriate ) to each option based on the 95 % confidence interval around the mean . Ratings were used to develop guidelines for preferred strategies in key clinical situations . This study received financial support from multiple sponsors , with the panel kept blind to sponsorship to reduce possible bias . Medication ratings were based on responses of only those respondents with direct experience with each drug . In reporting practice patterns , the panel was asked to respond based on actual data rather than estimates . RESULTS The expert panel reached consensus on 78 % of the options rated on the 9-point scale . The responses suggest that physicians can make provisional diagnoses with some confidence and that pharmacological and nonpharmacological interventions are selected differentially based on diagnosis and other salient demographic and medical features . BNZs are recommended when no data are available , when there is no specific treatment ( e.g. , personality disorder ) , or when they may have specific benefits ( e.g. , intoxication ) . No single SGA emerges as a nonspecific replacement for haloperidol ; instead , different SGAs are preferred in various circumstances consistent with current evidence . To the degree that haloperidol is recommended , it is almost always in combination with a BNZ ; haloperidol alone is preferred only in the medically compromised . In contrast , the SGAs are more often recommended for use alone , and the panel would avoid combining BNZs with some SGAs . Oral risperidone alone or combined with a BNZ receives strong support in a variety of situations . Oral olanzapine was rated very similarly to risperidone , with slightly higher ratings than risperidone in situations where it has been studied ( e.g. , schizophrenia , mania ) and slightly lower ratings where it has not been studied or safety may be a concern ; there was less support for combining oral olanzapine with a BNZ . For oral treatment of agitation related to schizophrenia or mania , olanzapine alone , risperidone alone or combined with a BNZ , and haloperidol plus a BNZ are first line , with strong support also for combining divalproex with the antipsychotic for presumed mania . Oral ziprasidone and quetiapine generally received similar second-line ratings in most situations . If a parenteral agent is needed , i.m . olanzapine alone received somewhat more support than i.m . ziprasidone alone ; however , there was more support for i.m . ziprasidone alone or combined with a BNZ than for i.m . olanzapine plus a BNZ , probably reflecting safety concerns . For example , for a provisional diagnosis of schizophrenia , first-line parenteral options are i.m . olanzapine or ziprasidone alone or i.m . haloperidol or ziprasidone combined with a BNZ . Neither of the new parenteral formulations received as much support as traditional agents ( i.m . BNZs , i.m . haloperidol ) when no data are available or the diagnosis involves medical comorbidity or intoxication . When initial intervention with risperidone , ziprasidone , or haloperidol is unsuccessful , the panel recommended adding a BZD to the antipsychotic . However , when initial treatment with olanzapine or quetiapine is unsuccessful , increasing the dosage is recommended . Perphenazine was consistently rated second line and droperidol and chlorpromazine received third-line ratings throughout . CONCLUSIONS Within the limits of expert opinion and with the expectation that future research data will take precedence , these guidelines suggest that the SGAs are now preferred for agitation in the setting of primary psychiatric illnesses but that BNZs are preferred in other situations Forensic psychiatry in Europe is a specialty primarily concerned with individuals who have either offended or present a risk of doing so , and who also suffer from a psychiatric condition . These mentally disordered offenders ( MDOs ) are often cared for in secure psychiatric environments or prisons . In this guidance paper we first present an overview of the field of forensic psychiatry from a European perspective . We then present a review of the literature summarising the evidence on the assessment and treatment of MDOs under the following headings : The forensic psychiatrist as expert witness , risk , treatment setting s for mentally disordered offenders , and what works for MDOs . We undertook a rapid review of the literature with search terms related to : forensic psychiatry , review articles , r and omised controlled trials and best practice . We search ed the Medline , Embase , PsycINFO , and Cochrane library data bases from 2000 onwards for adult groups only . We scrutinised publications for additional relevant literature , and search ed the websites of relevant professional organisations for policies , statements or guidance of interest . We present the findings of the scientific literature as well as recommendations for best practice drawing additionally from the guidance documents identified . We found that the evidence base for forensic-psychiatric practice is weak though there is some evidence to suggest that psychiatric care produces better outcomes than criminal justice detention only . Practitioners need to follow general psychiatric guidance as well as that for offenders , adapted for the complex needs of this patient group , paying particular attention to long-term detention and ethical issues OBJECTIVES New treatment options for dementia and its behavioral disturbances have become available since publication of The Expert Consensus Guidelines on the Treatment of Agitation in Older Persons with Dementia in 1998 . While only 2 cholinesterase inhibitors , donepezil and tacrine , were available in 1998 , 3 new cognitive-enhancing agents have been introduced since that time as well as several new atypical antipsychotics and antidepressants . However , there are still limited data from controlled studies to guide clinicians in choosing among these agents and sequencing and combining treatments . We therefore conducted a new survey study of expert opinion on the treatment of cognitive impairment and behavioral disturbances associated with dementia . METHODS Based on a literature review , a 61- question survey was developed with 1,225 options . Most options were scored using a modified version of the R AND 9-point scale for rating appropriateness of medical decisions . For other options , the experts were asked to write in answers . The survey was sent to 50 North American experts on dementia , 100 % of whom completed it . In analyzing responses to items rated on the 9-point scale , consensus was defined as a nonr and om distribution of scores by chi-square " goodness-of-fit " test . Based on the 95 % confidence interval around the mean , we assigned a categorical rank ( first line/preferred , second line/alternate , third line/usually inappropriate ) to each option . Guidelines indicating preferred treatment strategies were then developed for selected clinical situations . RESULTS For patients at risk for dementia , the experts recommended control of hypertension and diabetes . They also recommended aspirin and would consider a lipid-lowering agent in patients at risk for vascular dementia . Cholinesterase inhibitors were an option for patients with mild cognitive impairment ( i.e. , at risk for Alzheimer 's dementia [ AD ] ) . To slow cognitive impairment in mild/moderate AD , the experts recommended a cholinesterase inhibitor alone or combined with vitamin E. Donepezil and  galantamine  were the preferred cholinesterase inhibitors . The experts recommended combining a cholinesterase inhibitor with a N-methyl-D-aspartate ( NMDA ) antagonist ( e.g. , memantine ) if a patient with mild/moderate dementia has an inadequate response to monotherapy . Control of hypertension and diabetes was the treatment of choice , in patients with mild/moderate vascular or mixed AD/vascular dementia , with aspirin another first-line option . Cholinesterase inhibitors were also a first-line option for mild/moderate mixed AD/vascular dementia . Among nonpharmacological interventions for mild/moderate dementia , the experts recommended caregiver education , supportive therapy for caregivers , referral to day treatment , exercise programs , and respite care . For moderate/severe AD or mixed AD/vascular dementia , the experts recommended combining an NMDA antagonist with a cholinesterase inhibitor . For moderate/severe vascular or mixed AD/vascular dementia , they recommended control of hypertension and diabetes . The experts ' ratings underscore the importance of nonpharmacological strategies aim ed at reducing caregiver burden in more severe dementia . Management of agitation and other behavioral disturbances was another focus of this study . The experts recommended using an atypical antipsychotic for agitation associated with delirium , psychosis , aggression , or anger . They would also consider divalproex to manage anger with a risk of physical aggression . Selective serotonin reuptake inhibitors were recommended for the treatment of depression or anxiety in patients with dementia . Benzodiazepines or atypical antipsychotics were viewed as short-term options for acute anxiety .  Trazodone was recommended for insomnia . The experts also gave recommendations concerning dosage levels , duration of treatment , and choice of medications for patients with different complicating conditions . CONCLUSIONS The experts reached high levels of consensus on key steps in treating dementia and associated behavioral disturbances . Within the limits of expert opinion and with the expectation that new research data will take precedence , these guidelines may provide direction for clinicians offering care to patients with dementia Objectives . Behavioral emergencies are a common and serious problem for consumers , their communities , and the healthcare setting s on which they rely , but there is little research to guide provider responses to this challenge . Key constructs such as agitation have not been adequately operationalized so that the criteria defining a behavioral emergency are vague . A significant number of deaths of patients in restraint has focused government and regulators on these issues , but a consensus about key elements in the management of behavioral emergencies has not yet been articulated by the provider community . The authors assembled a panel of 50 experts to define the following elements : the threshold for emergency interventions , the scope of assessment for varying levels of urgency and cooperation , guiding principles in selecting interventions , and appropriate physical and medication strategies at different levels of diagnostic confidence and for a variety of etiologies and complicating conditions . Method . A written  survey with 808 decision points was completed by 50 experts . A modified version of the R AND Corporation 9-point scale for rating appropriateness of medical decisions was used to score options . Consensus on each option was defined as a non-r and om distribution of scores by chi-square “ goodness-of-fit ” test . We assigned a categorical rank ( first line/preferred choice , second line/ alternate choice , third line/usually inappropriate ) to each option based on the 95 % confidence interval around the mean rating . Guideline tables were constructed describing the preferred strategies in key clinical situations . Results . The expert panel reached consensus on 83 % of the options . The relative appropriateness of emergency interventions was ascertained for a continuum of behaviors . When asked about the frequency with which emergency interventions  ( parenteral medication , restraint , seclusion ) were required in their services , 47 % of the experts reported that such interventions were necessary for 1%–5 % of patients seen in their services and 32 % for 6%–20 % . In general , the consensus of this panel lends support to many elements of recent regulations from the Health Care Financing Administration ( now the Centers for Medicare and Medicaid Services ) , including the timing of clinician assessment and re assessment and the intensity of nursing care . However , the panel did not endorse the concept of “ chemical restraint , ” instead favoring the idea that medications are treatments for target behaviors in behavioral emergencies even when the causes of these behaviors are not well understood . Control of aggressive behavior emerged as the highest priority during the emergency ; however , preserving the physician-patient relationship was rated a close second and became the top priority in the long term . Oral medications , particularly concentrates , were clearly preferred if it is possible to use them . Benzodiazepines alone were top rated in 6 of 12 situations . High-potency conventional antipsychotics used alone never received higher ratings than benzodiazepines used alone . A combination of a benzodiazepine and an antipsychotic was preferred for patients with suspected schizophrenia , mania , or psychotic depression . There was equal support for high-potency conventional or atypical antipsychotics  ( particularly liquids ) in oral combinations with benzodiazepines .  Droperidol emerged in fourth place in some situations requiring an injection . Conclusions . To evaluate many of the treatment options in this survey , the experts had to extrapolate beyond controlled data . Within the limits of expert opinion and with the expectation that future research data will take precedence , these guidelines provide some direction for addressing common clinical dilemmas in the management of psychiatric emergencies and can be used to inform clinicians in acute care setting s regarding the relative merits of various strategies Acutely psychotic patients presenting as psychiatric emergencies with aggression or agitation are often administered conventional antipsychotics intramuscularly . However , patients view intramuscular administration as coercive , and conventional antipsychotics are often associated with adverse events . In this open study , consecutive adult patients presenting with an acute exacerbation of schizophrenia or other psychotic disorder were assigned to oral risperidone 2 - 6 mg/day ( n = 48 ) or oral zuclopenthixol 20 - 50 mg/day ( n = 27 ) for 7 - 14 days . Lorazepam ( either oral or intramuscular ) was administered to both groups as needed . Patients were assessed regularly until day 14 or discharge . Mean Positive And Negative Syndrome Scale ( PANSS ) aggression scores ( sum of item scores on excitement , poor impulse control , hostility and uncooperativeness ) decreased steadily and similarly in both groups ; the mean changes from baseline were statistically significant at days 10 and 14 and at study end-point . The mean decrease at study end-point in the PANSS component score for hostility was statistically significant in the risperidone group , but not in the zuclopenthixol group . Social Dysfunction and Aggression Scale aggression scores and Clinical Global Impression scores decreased significantly and similarly in both groups . Overall , 18.7 % of patients showed minor extrapyramidal symptoms during the study , but only 16.7 % of risperidone-treated patients , compared to 59.3 % of zuclopenthixol-treated patients , received anti-parkinsonian medication ( p < 0.001 ) . Lorazepam was administered to all of the patients assigned to risperidone and to 89 % of those assigned to zuclopenthixol . Oral risperidone plus lorazepam is a convenient , effective and well-tolerated alternative to conventional antipsychotics for the treatment of acute psychosis in emergency psychiatry Background Psychomotor agitation can be associated with a wide range of medical conditions . Although clinical practice advocates the use of several drugs for the management of psychomotor agitation , there are still very few controlled studies comparing the profiles of action and the adverse effects of different drugs that induce tranquilization . Objectives The purpose of this study was to compare the efficacy and safety of 4 low-dose pharmacological interventions used to control psychomotor agitation guided by the clinical response . Methods Using a r and omized , rated-blind design , 100 agitated patients were assigned to receive 1 of 4 treatments : haloperidol ( 2.5 mg ) + promethazine ( 25 mg ) ( HLP + PMZ ) , haloperidol ( 2.5 mg ) + midazolam ( 7.5 mg ) ( HLP + MID ) , ziprasidone ( 10 mg ) ( ZIP ) , or olanzapine ( 10 mg ) ( OLP ) . Patients were evaluated just before the intervention and after 30 , 60 , and 90 minutes , using the Agitation-Calmness Evaluating Scale . Adverse effects were assessed within 24 hours after the intervention , using selected items from the UKU Scale ( Ugvalg Klinisk Undersgelser Side Effect Scale ) . According to the clinical indication , medication could be repeated twice after the first injection . Data were analyzed using general linear model with repeated measures and logistic regression . Results All treatment options promoted a reduction in agitation , without causing excessive sedation , although a lower reduction in agitation was observed with HLP + PMZ and ZIP compared with HLP + MID and OLZ . The need for an additional dose of medication was observed in 22 patients , and only 8 remained agitated during the entire 90-minute period . A higher risk for the development of extrapyramidal symptoms within the following 24 hours was observed with HLP + PMZ . Discussion Low doses of haloperidol combined with midazolam can be as effective as olanzapine in reducing psychomotor agitation without increasing the risk of extrapyramidal effects . Because of the higher risk for the occurrence of extrapyramidal symptoms , the combination of haloperidol with promethazine should be considered a second-line treatment option ABSTRACT Background : The management of disruptive neuropsychiatric symptom ( NPS ) such as agitation and aggression ( A/A ) is a major priority in caring for people with Alzheimer 's disease ( AD ) . Few effective pharmacological or non-pharmacological options are available . Results of r and omized clinical trials ( RCTs ) of drugs for A/A have been disappointing . This may result from the absence of biological efficacy for medications tested in treating A/A. It may also be related to method ological issues such as the choice of outcomes . The aim of this review was to highlight key method ological issues pertaining to RCTs of current and emerging medications for the treatment of A/A in AD . Methods : We search ed PubMed / Medline , Cochrane Central Register of Controlled Trials , and Clinical Trials.gov for RCTs comparing medications with either placebo or other drugs in the treatment of A/A in AD , between January 2008 and December 2013 . Results : We identified a total of 18 RCTs ; of these , 11 were completed and 7 ongoing . Of the ongoing RCTs , only one is in Phase III . Seven of 10 completed RCTs with reported results did not report greater benefit from drug than placebo . Each of the completed RCTs used a different definition of " clinical ly significant A/A. " There was considerable heterogeneity in study design . The primary endpoints were largely proxy-based but a variety of scales were used . The definition of caregiver and scales used to assess caregiver outcomes were similarly heterogeneous . Placebo response was notable in all trials . Conclusions : This review highlights a great heterogeneity in RCTs design of drugs for A/A in AD and some key method ological issues such as definition of A/A , choice of outcome measures and caregiver participation that could be addressed by an expert consensus to optimize future trials design OBJECTIVE Clinical trials in psychiatry frequently fail to maximize clinical utility for practicing clinicians , or , stated differently , available evidence is not perceived by clinicians ( and other decision makers ) as sufficiently relevant to clinical practice , thereby diluting its impact . To attain maximum clinical relevance and acceptability , research ers must conduct clinical trials design ed to meet the needs of clinicians and others who are making decisions about patients ' care . The authors present the case for psychiatry 's adoption of the practical clinical trials model , which is widely used in research in other areas of medicine . METHOD The authors outline the characteristics and scope of practical clinical trials , give examples of practical clinical trials , and discuss the challenges of using the practical clinical trials model in psychiatry , including issues of funding . RESULTS Practical clinical trials , which are intended to provide generalizable answers to important clinical questions without bias , are characterized by eight key features : a straightforward clinical ly relevant question , a representative sample of patients and practice setting s , sufficient power to identify modest clinical ly relevant effects , r and omization to protect against bias , clinical uncertainty regarding the outcome of treatment at the patient level , assessment and treatment protocol s that enact best clinical practice s , simple and clinical ly relevant outcomes , and limited subject and investigator burden . CONCLUSIONS To implement the practical clinical trials model in psychiatry will require stable funding for network construction and maintenance plus method ological innovation in governance and trial selection , assessment , treatment , data management , site management , and data analytic procedures Abstract Intramuscular ( IM ) antipsychotics are preferred for efficient control of agitation symptoms . Previous studies have demonstrated that IM ziprasidone is efficacious and safe for treatment of agitation in schizophrenia . However , clinicians now recognize that racial differences may contribute to altered therapeutic response and tolerability . This study compared the efficacy and tolerability of IM ziprasidone versus IM haloperidol for the management of agitation in Chinese subjects with schizophrenia . Subjects with acute schizophrenia were r and omized to either ziprasidone ( n = 189 , 10 to 20 mg as required up to a maximum of 40 mg/d ) or haloperidol ( n = 187 , 5 mg every 4 to 8 hours to a maximum of 20 mg/d ) for 3 days . Psychiatric assessment s and adverse events were assessed at baseline , 2 , 4 , 24 , 48 , and 72 hours . In the ziprasidone group , 2.1 % of subjects discontinued versus 3.7 % in the haloperidol group . The least squares mean change ( SE ) from baseline to 72 hours in Brief Psychiatry Rating Scale total score was −17.32 ( 0.7 ) for ziprasidone ( n = 167 ) and −18.44 ( 0.7 ) for haloperidol ( n = 152 ) , with a 95 % confidence interval treatment difference of −0.7 to 2.9 . Fewer subjects experienced adverse events after ziprasidone ( n = 54 , 28.6 % ) than haloperidol ( n = 116 , 62.0 % ) , with a notably higher incidence of extrapyramidal symptoms in the haloperidol group ( n = 69 , 36.9 % ) compared to the ziprasidone group ( n = 4 , 2.1 % ) . For controlling agitation in schizophrenia in this Chinese study , ziprasidone had a favorable tolerability profile and comparable efficacy and safety compared to haloperidol BACKGROUND Forensic psychiatry aims to reduce recidivism and makes use of risk assessment tools to achieve this goal . Various studies have reported on the predictive qualities of these instruments , but it remains unclear whether their use is associated with actual prevention of recidivism in clinical care . AIMS To test whether an intervention combining risk assessment and shared care planning is associated with a reduction in violent and criminal behaviour . METHOD A cluster r and omised controlled trial ( Netherl and s Trial Register number NTR1042 ) was conducted in three out-patient forensic psychiatric clinics . The intervention comprised risk assessment with the Short Term Assessment of Risk and Treatability ( START ) and a shared care planning protocol formulated according to shared decision-making principles . The control group received usual care . The outcome consisted of the proportion of clients with violent or criminal incidents at follow-up . RESULTS In total 58 case managers and 632 of their clients were included . In the intervention group ( n = 310 ) , 65 % received the intervention at least once . Findings showed a general treatment effect ( 22 % of clients with an incident at baseline v. 15 % at follow-up , P<0.01 ) but no significant difference between the two treatment conditions ( odds ratio ( OR ) = 1.46 , 95 % CI 0.89 - 2.44 , P = 0.15 ) . CONCLUSIONS Although risk assessment is common practice in forensic psychiatry , our results indicate that the primary goal of preventing recidivism was not reached through risk assessment embedded in shared decision-making Abstract : Topiramate is an antiepileptic drug , recently also used in the treatment of psychiatric diseases . Inasmuch as topiramate and valproate , which are currently used for aggressive behavior , share several pharmacological mechanisms ( positive modulatory effect on the GABA activity and negative modulatory effect on glutamatergic neurotransmission ) , the objective of the present study was to compare the pharmacological effects of topiramate with those of valproate and their combination in patients with psychiatric disorders showing marked aggression and agitation . A retrospective , case-controlled , mirror-image study was carried out in a sample of 45 in patients affected by schizophrenia , schizoaffective and bipolar disorder , and hospitalized in a maximum-security Canadian psychiatry hospital .  Overt Aggression Scale , Agitation-Calmness Evaluation Scale , number and intensity of psychotic episodes , number of episodes of withdrawal from group activities per week , and number of therapeutic isolation per week and of strict surveillance intervention per week were evaluated before and after the treatments . Results indicate that patients treated with topiramate show a decrease in the average score of the Overt Aggression Scale , a decrease of episodes of agitation and of strict surveillance interventions . This effect was similar to the group treated with valproate or with the combination of valproate-topiramate . However , valproate therapy , but not topiramate therapy , decreased the intensity of agitation episodes measured by the Agitation-Calmness Evaluation Scale ;  valproate and the combination topiramate-valproate decreased the number of psychotic disorganization episodes as well . These results suggest that topiramate could be a valid medicine in the control of aggression in psychosis . Double-blind , r and omized , placebo-controlled studies need to further assess this pharmacological indication This study aim ed to investigate the long-term effects of group music therapy on  agitation manifested by nursing home residents with Alzheimer 's disease . A non-r and omised experimental design was employed with one group receiving weekly music therapy ( n = 26 ) and another group receiving st and ard nursing home care ( n = 19 ) .  Agitation levels were measured five times over one year using the Cohen-Mansfield Agitation Inventory ( Cohen-Mansfield , J. ( 1989 ) . Agitation in the elderly . In N. Billig & P. V. Rabins ( Eds . ) , Issues in geriatric psychiatry ( pp . 101–113 ) . Basel , Switzerl and : Karger ) . Although music therapy participants showed short-term reductions in agitation , there were no significant differences between the groups in the range , frequency , and severity of agitated behaviours manifested over time . Multiple measures of treatment efficacy are necessary to better underst and the long-term effects music therapy programs have on this population Abstract Background Kraepelin ’s partial interpretation of agitated depression  as a mixed state of “ manic-depressive insanity ” ( including the current concept of bipolar disorder ) has recently been the focus of much research . This paper tested whether , how , and to what extent both psychomotor symptoms , agitation and retardation in depression are related to bipolarity and anxiety . Method The prospect i ve Zurich Study assessed psychiatric and somatic syndromes in a community sample of young adults ( N = 591 ) ( aged 20 at first interview ) by six interviews over 20 years ( 1979–1999 ) .  Psychomotor symptoms of agitation and retardation were assessed by professional interviewers from age 22 to 40 ( five interviews ) on the basis of the observed and reported behaviour within the interview section on depression . Psychiatric diagnoses were strictly operationalised and , in the case of bipolar-II disorder , were broader than proposed by DSM-IV-TR and ICD-10 . As indicators of bipolarity , the association with bipolar disorder , a family history of mania/hypomania/cyclothymia , together with hypomanic and cyclothymic temperament as assessed by the general  behavior inventory  ( GBI ) [ 15 ] , and mood lability ( an element of cyclothymic temperament ) were used . Results Agitated and retarded depressive states were equally associated with the indicators of bipolarity and with anxiety . Longitudinally , agitation and retardation were significantly associated with each other ( OR = 1.8 , 95 % CI = 1.0–3.2 ) , and this combined group of major depressives showed stronger associations with bipolarity , with both hypomanic/cyclothymic and depressive temperamental traits , and with anxiety . Among agitated , non-retarded depressives , unipolar mood disorder was even twice as common as bipolar mood disorder . Conclusion Combined agitated and retarded major depressive states are more often bipolar than unipolar , but , in general , agitated depression ( with or without retardation ) is not more frequently bipolar than retarded depression ( with or without agitation ) , and pure agitated depression is even much less frequently bipolar than unipolar . The findings do not support the hypothesis that agitated depressive syndromes are mixed states . Limitations The results are limited to a population up to the age of 40 ; bipolar-I disorders could not be analysed ( small N ) OBJECTIVE To provide expert recommendations for the safe and effective application of repetitive transcranial magnetic stimulation ( rTMS ) in the treatment of major depressive disorder ( MDD ) . PARTICIPANTS Participants included a group of 17 expert clinicians and research ers with expertise in the clinical application of rTMS , representing both the National Network of Depression Centers ( NNDC ) rTMS Task Group and the American Psychiatric Association Council on Research ( APA CoR ) Task Force on Novel Biomarkers and Treatments . EVIDENCE The consensus statement is based on a review of extensive literature from 2 data bases ( OvidSP MEDLINE and PsycINFO ) search ed from 1990 through 2016 . The search terms included variants of major depressive disorder and transcranial magnetic stimulation . The results were limited to articles written in English that focused on adult population s. Of the approximately 1,500 retrieved studies , a total of 118 publications were included in the consensus statement and were supplemented with expert opinion to achieve consensus recommendations on key issues surrounding the administration of rTMS for MDD in clinical practice setting s. CONSENSUS PROCESS In cases in which the research evidence was equivocal or unclear , a consensus decision on how rTMS should be administered was reached by the authors of this article and is denoted in the article as " expert opinion . " CONCLUSIONS Multiple r and omized controlled trials and published literature have supported the safety and efficacy of rTMS antidepressant therapy . These consensus recommendations , developed by the NNDC rTMS Task Group and APA CoR Task Force on Novel Biomarkers and Treatments , provide comprehensive information for the safe and effective clinical application of rTMS in the treatment of MDD PURPOSE The study evaluated whether seclusion and coercive incidents would be reduced in extent and number if involuntary medication was the first choice of intervention . Patients admitted to an acute psychiatric ward were r and omly allocated to two groups . In Group 1 , involuntary medication was the intervention of first choice for dealing with agitation and risk of violence . In Group 2 , seclusion was the intervention of first choice . Patients ' characteristics between the groups were compared by Pearson χ(2 ) and two- sample t-tests ; the incidence rates and risk ratios ( RRs ) were calculated to examine differences in number and duration of coercive incidents . In Group 1 , the relative risk of being secluded was lower than in Group 2 , whereas the risk of receiving involuntary medication was higher . However , the mean duration of the seclusion incidents did not differ significantly between the two groups ; neither did the total number of coercive incidents . Although the use of involuntary medication could successfully replace and reduce the number of seclusions , alternative interventions are needed to reduce the overall number and duration of coercive incidents . A new policy for managing acute aggression - such as involuntary medication - can be implemented effectively only if certain conditions are met Background Agitated or violent patients constitute 10 % of all emergency psychiatric treatment . Management guidelines , the preferred treatment of clinicians and clinical practice all differ . Systematic review s show that all relevant studies are small and none are likely to have adequate power to show true differences between treatments . Worldwide , current treatment is not based on evidence from r and omised trials . In Brazil , the combination haloperidol-promethazine is frequently used , but no studies involving this mix exist . Methods TREC-Rio ( Tranquilização Rápida-Ensaio Clínico [ Translation : Rapid Tranquillisation- Clinical Trial ] ) will compare midazolam with haloperidol-promethazine mix for treatment of agitated patients in emergency psychiatric rooms of Rio de Janeiro , Brazil . TREC-Rio is a r and omised , controlled , pragmatic and open study . Primary measure of outcome is tranquillisation at 20 minutes but effects on other measures of morbidity will also be assessed . TREC-Rio will involve the collaboration of as many health care professionals based in four psychiatric emergency rooms of Rio as possible . Because the design of this trial does not substantially complicate clinical management , and in several aspects simplifies it , the study can be large , and treatments used in everyday practice can be evaluated The British Association for Psychopharmacology ( BAP ) coordinated a meeting of experts to review and revise its first ( 2006 ) Guidelines for clinical practice with  anti-dementia drugs .  As before , levels of evidence were rated using accepted st and ards which were then translated into grade s of recommendation A to D , with A having the strongest evidence base ( from r and omized controlled trials ) and D the weakest ( case studies or expert opinion ) . Current clinical diagnostic criteria for dementia have sufficient accuracy to be applied in clinical practice ( B ) and brain imaging can improve diagnostic accuracy ( B ) . Cholinesterase inhibitors ( donepezil , rivastigmine , and galantamine ) are effective for mild to moderate Alzheimer ’s disease ( A ) and memantine for moderate to severe Alzheimer ’s disease ( A ) . Until further evidence is available other drugs , including statins , anti-inflammatory drugs , vitamin E and Ginkgo biloba , can not be recommended either for the treatment or prevention of Alzheimer ’s disease ( A ) . Neither cholinesterase inhibitors nor memantine are effective in those with mild cognitive impairment ( A ) . Cholinesterase inhibitors are not effective in frontotemporal dementia and may cause agitation ( A ) , though selective serotonin reuptake inhibitors may help behavioural ( but not cognitive ) features ( B ) . Cholinesterase inhibitors should be used for the treatment of people with Lewy body dementias ( Parkinson ’s disease dementia and dementia with Lewy bodies ( DLB ) ) , especially for neuropsychiatric symptoms ( A ) . Cholinesterase inhibitors and memantine can produce cognitive improvements in DLB ( A ) . There is no clear evidence that any intervention can prevent or delay the onset of dementia . Although the consensus statement focuses on medication , psychological interventions can be effective in addition to pharmacotherapy , both for cognitive and non-cognitive symptoms . Many novel pharmacological approaches involving strategies to reduce amyloid and /or tau deposition are in progress . Although results of pivotal studies are awaited , results to date have been equivocal and no disease-modifying agents are either licensed or can be currently recommended for clinical use Agitation is a vexing problem frequently observed in emergency department acute psychiatric patients , yet no instruments to measure agitation in this setting and population were found upon review of the literature . Previously developed agitation rating scales are limited by the length of observation they require , their need for participation by the patient , complexity in scoring , and a lack of validity in this setting and population . The purpose of this study was to psychometrically evaluate and refine an observation-based agitation scale for use with emergency department acute psychiatric patients . Using a method ological design , the 21-item Agitation Severity Scale was utilized to assess 270 adult psychiatric patients in the emergency setting in a prospect i ve , observational fashion . Reliability analysis , item analysis , exploratory factor analysis , and validity assessment s were completed . The relationship between Agitation Severity Scale scores and scores on the previously established Overt Agitation Severity Scale was evaluated . The instrument was reduced to 17 items representing four factors ( Aggressive Behaviors , Interpersonal Behaviors , Involuntary Motor Behaviors , and Physical Stance ) that accounted for nearly 70 % of observed variance , Cronbach 's & agr ; = 0.91 . Evidence of internal consistency reliability , equivalence reliability , construct validity , and convergent validity was established . Through this study , the 17-item Agitation Severity Scale demonstrated acceptable levels of reliability and validity when used with acute psychiatric patients in the emergency setting . This instrument holds promise as a method of enhancing clinical communication about agitation , evaluating the efficacy of interventions aim ed at decreasing agitation , and as a research tool Individuals with mental illness and co-occurring addictive disorders account for 44 % of the cigarettes sold in the United States ( JAMA 284:2606–2610 , 2000 ) . Smokers with mental illness face serious tobacco-related consequences , including increased morbidity and mortality , isolation , stigma , and financial hardship . Tobacco use also increases the metabolism of some antipsychotic and antidepressant medications , with the potential for subtherapeutic treatment and higher rates of rehospitalization . Nearly half of U.S. state psychiatric hospitals now ban tobacco use on their premises . The American Psychiatric Association identifies psychiatric hospitalizations as an ideal opportunity to treat tobacco dependence . Yet little research has examined tobacco cessation treatments in inpatient psychiatry . If tobacco dependence is left unaddressed , most psychiatric patients return to smoking immediately after discharge ( American Journal of Addictions 15:15–22 , 2006 ) . Multi-component interventions are needed that address the motivational , behavioral , and physiological aspects of nicotine dependence for smokers with co-occurring psychiatric disorders . We briefly describe an innovative tobacco treatment intervention initiated during psychiatric hospitalization . The intervention combines a computer-delivered expert system intervention and manual based on the transtheoretical model , an individual counseling session , and nicotine replacement therapy ( NRT ) . The model identifies five stages of change : precontemplation ( no immediate intention to stop smoking ) , contemplation ( intending to quit in the next six months ) , preparation ( considering quitting in the next month with a quit attempt in the past year ) , action ( quit smoking for less than six months ) , and maintenance ( smoke-free for at least six months ) . The 20-minute computer intervention generates individualized feedback at a sixth- grade reading level to guide participants through the stages of quitting smoking and to direct them to relevant sections of the manual . In a 30-minute session with the participant , study counselors review the printed feedback and manual , identify and support goals concerning tobacco use , and discuss proper use of NRT .  Nine hospitalized psychiatric patients representing a range of psychiatric , demographic , and tobacco-use characteristics intensively evaluated the intervention components . Despite having fairly limited computer experience , all agreed or strongly agreed that the program was easy to underst and and gave sound advice , and all recommended the computer program to others . Most participants required assistance with program navigation , suggesting the need for more user-friendly capabilities , such as a touch screen and audio . All participants read part of the manual , and most read beyond their stage-of-change chapter . Participants rated the manual highly for its organization and helpful strategies , describing it as “ realistic ” and “ easy to underst and … good for any person to read . ” Participants also rated the counseling session highly , citing the openness of the dialogue , the focus on their needs and interests , and the lack of pressure to quit : “ She did n’t push any points … she just presented the material . She was open , nonjudgmental . … She let me come to my own conclusions that I want to quit . ” Most participants used NRT , identified several benefits , and expressed interest in continuing NRT after hospitalization . Side effects also were noted . Of concern , most participants stated that clinical staff did not instruct them in proper use of NRT . This small and intensive evaluation suggests that the intervention provides a viable and acceptable strategy for initiating tobacco treatment in the inpatient psychiatric setting . In a r and omized clinical trial , we are evaluating efficacy of the intervention relative to usual care . With a 79 % recruitment rate , we enrolled 224 participants . After the brief hospital stay , intervention participants received ten weeks of NRT and two additional computer contacts , and their outpatient providers were informed of their cessation goals . Follow-up continues for 18 months . Psychiatric hospitals are making important strides in banning tobacco use . Bans , however , are only part of a much larger strategy needed to overcome the high rates of tobacco use in population s with mental illness . If cessation services are not offered , patients may misperceive smoking bans as punitive and themselves as unworthy of receiving intervention on this deadly addiction . When smoking was allowed on psychiatric units , an average of 15 minutes was spent per nursing shift managing patients ’ cigarette use . Ideally , a portion of the time saved with a no-smoking policy could be shifted to delivery of cessation services . The findings present an innovative , acceptable , multicomponent intervention for initiating tobacco treatment in inpatient psychiatry Background Severe trauma continues to represent a global public health issue and mortality and morbidity in trauma patients remains substantial . A number of initiatives have aim ed to provide guidance on the management of trauma patients . This document focuses on the management of major bleeding and coagulopathy following trauma and encourages adaptation of the guiding principles to each local situation and implementation within each institution . Methods The pan-European , multidisciplinary Task Force for Advanced Bleeding Care in Trauma was founded in 2004 and included representatives of six relevant European professional societies . The group used a structured , evidence -based consensus approach to address scientific queries that served as the basis for each recommendation and supporting rationale . Expert opinion and current clinical practice were also considered , particularly in areas in which r and omised clinical trials have not or can not be performed . Existing recommendations were reconsidered and revised based on new scientific evidence and observed shifts in clinical practice ; new recommendations were formulated to reflect current clinical concerns and areas in which new research data have been generated . This guideline represents the fourth edition of a document first published in 2007 and up date d in 2010 and 2013 . Results The guideline now recommends that patients be transferred directly to an appropriate trauma treatment centre and encourages use of a restricted volume replacement strategy during initial resuscitation . Best- practice use of blood products during further resuscitation continues to evolve and should be guided by a goal -directed strategy . The identification and management of patients pre-treated with anticoagulant agents  continues to pose a real challenge , despite accumulating experience and awareness . The present guideline should be viewed as an educational aid to improve and st and ardise the care of the bleeding trauma patients across Europe and beyond . This document may also serve as a basis for local implementation . Furthermore , local quality and safety management systems need to be established to specifically assess key measures of bleeding control and outcome . Conclusions A multidisciplinary approach and adherence to evidence -based guidance are key to improving patient outcomes . The implementation of locally adapted treatment algorithms should strive to achieve measureable improvements in patient outcome OBJECTIVE To summarize the discussion that took place at a public workshop , co-sponsored by the U.S. Food and Drug Administration , the American Urological Association , and Society of Urologic Oncology review ing the current state of the art for partial gl and ablation ( PGA ) for the management of patients with prostate cancer . The purpose of this workshop was to discuss potential indications , current available evidence , and design s for future trials to provide the evidence needed by patients and providers to decide how and when to use PGA . METHODS A workshop evaluating  PGA for prostate cancer was held in New Orleans , Louisiana , in May 2015 . Invited experts representing all stakeholders and attendees discussed the regulatory development of medical products , technology available , potential indications , and design s of trials to evaluate this modality of therapy . RESULTS The panel presented the current information on the technologies available to perform PGA , the potential indications , and results of prior consensus conferences . Use of magnetic resonance imaging for patient selection , guide therapy , and follow-up was discussed . Design s of trials to assess PGA outcomes were discussed . CONCLUSION The general consensus was that currently available technologies are capable of selective ablation with reasonable accuracy , but that criteria for patient selection remain debatable , and long-term cancer control remains to be established in properly design ed and well-performed prospect i ve clinical trials . Concerns include the potential for excessive , unnecessary use in patients with low-risk cancer and , conversely , that current diagnostic techniques may underestimate the extent and aggressiveness of some cancers , leading to inadequate treatment The actual incidence of neurologic dysfunction result ing from hemorrhagic complications associated with neuraxial blockade is unknown . Although the incidence cited in the literature is estimated to be less than 1 in 150,000 epidural and less than 1 in 220,000 spinal anesthetics , recent epidemiologic surveys suggest that the frequency is increasing and may be as high as 1 in 3000 in some patient population s. Overall , the risk of clinical ly significant bleeding increase with age , associated abnormalities of the spinal cord or vertebral column , the presence of an underlying coagulopathy , difficulty during needle placement , and an indwelling neuraxial catheter during sustained anticoagulation ( particularly with st and ard heparin or low-molecular weight heparin ) . The need for prompt diagnosis and intervention to optimize is also consistently reported . In response to these patient safety issues , the American Society of Regional Anesthesia and Pain Medicine ( ASRA ) convened its Third Consensus Conference on Regional Anesthesia and Anticoagulation . Practice guidelines or recommendations summarize evidence -based review s. However , the rarity of spinal hematoma defies a prospect i ve r and omized study , and there is no current laboratory model . As a result , the ASRA consensus statements represent the collective experience of recognized experts in the field of neuraxial anesthesia and anticoagulation . These are based on case reports , clinical series , pharmacology , hematology , and risk factors for surgical bleeding . An underst and ing of the complexity of this issue is essential to patient management BACKGROUND Patient involvement in the decision-making process is a key element for good clinical practice . Few data are available on patient involvement in psychiatry . AIMS To assess in a psychiatric out-patient context how psychiatrists involve patients in therapeutic decisions and to determine the extent to which patient and psychiatrist characteristics contribute to patient involvement . METHOD Eighty transcripts from audiotaped first out-patient consultations , conducted by 16 psychiatrists , were rated with the OPTION ( observing patient involvement ) scale . Interrater reliability indices were obtained for 30 r and omly selected interviews . Associations between OPTION scores and some clinical and socio-demographic variables were tested using t-test , ANOVA and Pearson 's correlation coefficient where appropriate . The distribution of scores for each psychiatrist was assessed by intracluster correlation coefficients . RESULTS Interrater reliability and internal consistency of the OPTION scale in the psychiatric setting were satisfactory . The total score and the ratings for the single OPTION items showed a skewed distribution , with a prevalence of scores in the low range of abilities , corresponding to minimal attempts to involve patients or a minimal skill level . CONCLUSIONS The OPTION scale proves to be a reliable instrument to assess patient involvement in a psychiatric setting . Psychiatrists showed poor patient involvement abilities parallel to previous findings in psychiatry and primary care . They need to be encouraged to share treatment decisions with their patients and to apply patient involvement skills . Further research is needed to establish which patient variables and clinical setting s in psychiatry are more amenable to shared decisions , and how participation of psychiatric patients in treatment decisions will affect the outcome This special article pays tribute to Wayne Katon , MD ( 1950 - 2015 ) with a Gedenkschrift , or review , of his prolific academic career . Abstract s of all of Dr. Katon 's Medline citations were review ed to develop a narrative of his seminal epidemiological and interventional research findings . Specifically , we describe : ( a ) how Dr. Katon 's clinical work and observational epidemiology and health services research informed and guided interventional studies ; ( b ) the evolution of multidisciplinary interventional trials from primary care-based psychiatric consultation to primary care-based collaborative care for depression to multicondition collaborative care ; and ( c ) how Dr. Katon 's research has informed the work of other leading research ers in the field of psychosomatic medicine and helped develop a new generation of research ers at the interface of psychiatry and primary care . For more than three decades , Dr. Katon led a multidisciplinary research team that conducted seminal epidemiological studies and r and omized trials and that influenced the thinking and research in the field of psychiatry in a number of areas : ( a ) the importance and impact of mental disorders presenting in primary care setting s and ( b ) the organization of effective multidisciplinary care for primary care patients with common mental disorders and comorbid medical conditions . Dr. Katon 's work revolutionized the care of psychiatric illnesses in primary care and other medical care setting s to the benefit of countless patients worldwide OBJECTIVES To recommend a consensus-derived set of performance-based tests of physical function for use in people diagnosed with hip or knee osteoarthritis ( OA ) or following joint replacement . METHODS An international , multidisciplinary expert advisory group was established to guide the study . Potential tests for consideration in the recommended set were identified via a survey of selected experts and through a systematic review of the measurement properties for performance-based tests . A multi-phase , consensus-based approach was used to prioritize and select performance-based tests by applying decision analysis methodology ( 1000Minds software ) via online decision surveys . The recommended tests were chosen based on available measurement-property evidence , feasibility of the tests , scoring methods and expert consensus . RESULTS Consensus incorporated the opinions of 138 experienced clinicians and research ers from 16 countries . The five tests recommended by the advisory group and endorsed by Osteoarthritis Research Society International ( OARSI ) were the  30-s chair-st and test , 40 m fast-paced walk test , a stair-climb test , timed up- and -go test and 6-min walk test . The first three were recommended as the minimal core set of performance-based tests for hip or knee OA . CONCLUSION The OARSI recommended set of performance-based tests of physical function represents the tests of typical activities relevant to individuals diagnosed with hip or knee OA and following joint replacements . These tests are complementary to patient-reported measures and are recommended as prospect i ve outcome measures in future OA research and to assist decision-making in clinical practice . Further research should be directed to exp and ing the measurement-property evidence of the recommended tests OBJECTIVES / AIMS The aim of this retrospective review was to determine the feasibility , safety , and potential therapeutic effects of acupuncture in an inpatient infant population and to obtain data that would support the design of a r and omized , controlled trial of acupuncture in infants . BACKGROUND Hospitalized infants are often exposed to sedative and analgesic medications to facilitate intensive and invasive medical care . With increasing concern about the potential neurotoxic effects of common analgesic and sedative medications , minimizing an infant 's exposure to such agents is desirable . Acupuncture can be therapeutic in adults and children , but data in infants are lacking . METHODS / MATERIAL S We performed a retrospective chart review of infants who received acupuncture during hospitalizations between 2008 and 2010 . Demographic data , diagnoses , reason for acupuncture consult , ventilator setting s , sedative/analgesic medication regimens , details of acupuncture therapy , and adverse effects were among data collected . RESULTS Ten infants were identified in this review , seven of whom had agitation issues , two of whom had feeding difficulties , and one had both symptoms . Six of the eight infants with agitation had a decrease in the use of sedative and analgesic medications over the acupuncture therapy period , and four of five initially requiring mechanical ventilation were successfully weaned . One of the three infants with oral aversion transitioned rapidly to oral intake .  Acupuncture therapy was well tolerated , and there were no complications observed . CONCLUSIONS In this small group of hospitalized infants , acupuncture was found to be safe , well tolerated , and therapeutic . More studies are warranted to define the role of acupuncture in this population In December 2003 , the European Council identified best practice as key for ensuring development of high- quality cancer-screening programs . To support national policies on cancer control , the European Union institutions progressed several initiatives on cancer . The European Commission ( EC ) Initiative on Breast Cancer ( ECIBC ) is the most recent of these projects and the most implementation driven . Within this initiative , the European Guidelines for Breast Cancer Screening and Diagnosis ( in short , European Breast Guidelines ) are being developed ( http://ecibc.jrc.ec.europa.eu/ ) . Guidelines are approaches to generally improve prevention , diagnosis , treatment , and follow-up of diseases , overcoming inappropriate variations by providing recommendations for best care . The new era of guidelines promises recommendations that are based on the best available evidence summarized in systematic review s while providing the necessary flexibility needed to individualize decisions . The best methods for development of practice guidelines have experienced intense elaboration and attention during the past decades ( 17 ) . The impetus for this attention has been the change from expert- or consensus-based to evidence -based health care recommendations . Although this change in terminology should express the shift from un systematic development of guidelines to systematic and trustworthy recommendations , it is often misunderstood and misconstrued as meaning that experts are now meaningless in the process or as if consensus through discussion is a matter of the past . Neither is correct . Experts from various disciplines and consensus as a result of deliberation remain a mainstay of health care guideline development ( 810 ) . These experts are responsible for prioritization of questions that should be addressed in guidelines ; judgments that result from interpretation of evidence , including the rating of the certainty of the available evidence ; and decisions about how the judgments on the different criteria bear on recommendations . What has changed over time in guideline development are the rules , the structure and explicitness of the process , and the guideline product . Indeed , review s of guideline development methodology and how guidelines can be improved have led to more structured and documented processes that allow a reduction of bias and provide balanced views of appropriately composed guideline panels ( 2 , 5 , 6 ) . Core components for trustworthy guideline development ( 13 , 5 , 7 , 11 ) include that guidelines be developed by a knowledgeable , multidisciplinary panel of experts and representatives from key affected groups ; be based on a systematic review of the existing evidence ; consider important patient subgroups and patient preferences as appropriate ; be based on an explicit and transparent process that minimizes distortions , biases , and conflicts of interest ( 12 ) ; provide a clear explanation of the logical relationships between alternative care options and health outcomes and provide ratings of both the quality of evidence and the strength of the recommendations ( 1316 ) ; and be reconsidered and revised as appropriate when important new evidence warrants modifications . In addition , greater transparency in linking the considered research evidence and the recommendations , as well as the requirement of making structured expert judgments , represents a shift in the guideline development paradigm ( 5 , 11 , 1719 ) . At the same time , developing guidelines for a large number of member states and those that aim to adapt the guidelines poses challenges , such as the feasibility of implementing strategies that may exist in some member countries but not others ( for example , organized population -based screening in Italy but not Greece ) . Addressing these challenges requires considerations that extend beyond strictly clinical efforts in guideline development and mastering the many factors that influence recommendations and their implementation . This article describes the rationale , methods , and processes the ECIBC has adopted to develop the European Breast Guidelines in the context of evolving international st and ards . It also describes an innovative approach to presenting , disseminating , and accelerating implementation of recommendations . Guideline Methodology and Development To adhere to the core requirements for guideline development , the EC has taken several steps . First , it selected , via an open call ( https://ecibc.jrc.ec.europa.eu/ guidelines -team ) , a panel with broad representation of expertise , knowledge , and background , which includes patients , health care professionals , epidemiologists , guideline method ologists , and others ( Appendix ) . These individuals voluntarily participate in the ECIBC and compose the guidelines development group ( GDG ) . Second , it ensured that all recommendations were supported by systematic review s of the evidence conducted by independent scientists from Cochrane Iberoamricathe systematic review team (SRT)following st and ard Cochrane Collaboration methods ( 20 , 21 ) . Third , because this is a women-centered initiative , we included women advocates in the GDG as full voting guideline group members . We separately considered important subgroups of women during recommendation development ( for example , different age groups ) , and we specifically focused on evidence that supports best ways of communicating this information to women to inform their decisions . Fourth , we applied EC conflict of interest rules ( http://ecibc.jrc.ec.europa.eu/rules ) , which are consistent with international recommendations , and used GRADE ( Grading of Recommendations Assessment , Development and Evaluation ) Evidence to Decision ( EtD ) frameworks to minimize the influence of competing interests on the recommendations ( 12 , 17 , 18 ) . These EtD frameworks help guideline panels use evidence in a structured , transparent way to inform decisions with a series of criteria , such as anticipated harms and benefits of the options considered , the certainty of the evidence for those effects , and the costs and feasibility of the options , to help them reach their decision . Fifth , using the GRADE approach to guideline development and its EtD frameworks , we focused our questions and recommendations on outcomes that matter to women and provided a rating of the certainty or quality of evidence and the strength of recommendations that is widely accepted as the reference st and ard ( Figures 1 and 2 ) . Sixth , our evidence review s are up to date when the recommendations are formulated , and we engage in international stakeholder feedback to ensure that recommendations remain timely and relevant to public health and clinical practice . The ECIBC is committed to review ing and updating the recommendations as required when new evidence becomes available . The general process is explained in Figure 3 and is based on the Guidelines International NetworkMcMaster Guideline Development Checklist ( https://hei grade .mcmaster.ca/ guideline -development/using-checklist ) ( 5 ) . Figure 1 . According to GRADE , certainty , quality , strength of evidence , or confidence in the estimate of effect is determined on the basis of a systematic review of the evidence for each outcome ( based on the domains risk of bias , indirectness , imprecision , inconsistency , and publication bias that lower certainty and , usually only for nonr and omized studies , large effects , doseresponse relations and opposing plausible residual confounding that may increase the certainty ) . For recommendations , the overall certainty is determined across outcomes based on the lowest certainty outcome among those critical for decision making for the specific context . The guidelines development group applies the GRADE Evidence -to-Decision frameworks to make recommendations that are made available on the European Commission Web site . ( Reproduced from reference 15 , with permission from Schnemann HJ . ) . GRADE = Grading of Recommendations Assessment , Development and Evaluation . Figure 2 . GRADE EtD frameworks . The GRADE EtD frameworks as available in the GRADE pro software ( www . grade pro.org ) . They help with structuring the entire guideline process into 4 sections and support the conduct of guideline group meetings , presentation , and implementation . They clarify the perspective that is taken by the guideline panel or decision maker and the type of question that is asked in the question section . The section on assessment includes the criteria if the problem is a priority , the balance of health benefits and harms , values and preferences related to the outcomes , cost , re sources and cost-effectiveness , equity , acceptability , and feasibility . Conclusions provide the decision or recommendation with a justification and implementation , as well as research considerations . The presentation function supports the conduct of guideline group meetings and facilitates the output of EtD frameworks to other implementation tools , such as Web sites , h and -held apps , and interactive decision aids . EtD = Evidence to Decision ; GRADE = Grading of Recommendations Assessment , Development and Evaluation ; HTA = health technology assessment ; PICO = population , intervention , comparators , and outcomes . Figure 3 . Approach to guideline development used by the European Commission Initiative on Breast Cancer . The European Commission JRC has oversight of the organization , budgeting , planning , and training . The JRC also manages conflicts of interest , documents all aspects of the work , and manages the membership and group processes . The guideline development group and JRC formulate the questions and work with the systematic review team on identifying and assessing the evidence . The guidelines development group is responsible for developing the recommendations . The JRC is responsible for most other aspects as described in the figure under dissemination , implementation , and updating . JRC = Joint Research Centre ; PICO = population , intervention , comparator , and outcomes . ( Reproduced with adaptation to the JRC process from BACKGROUND Older people living in residential aged care facilities ( RACFs ) are at a higher risk of suffering fractures than the community-dwelling older population . The first Consensus Conference on Treatment of Osteoporosis in RACFs in Australia , held in Sydney in July 2009 , aim ed to address some of the issues relating to the treatment of older residents with osteoporosis in RACFs . Considering that the field of osteoporosis diagnosis and management has significantly advanced in the last 5 years and that new evidence has been generated from studies performed within RACFs , a Second Consensus Conference was held in Sydney in November 2014 . METHODS An expert panel met in November 2014 in Penrith , NSW , Australia in an attempt to reach a consensus on diverse issues related to the treatment of osteoporosis at RACFs . Participants were selected by the scientific committee on the basis of their practice in an RACF and /or major published articles . The co-chairs distributed topics r and omly to all participants , who then had to propose a statement on each topic for approval by the conference after a short , evidence -based presentation , when possible . RESULTS This article provides an up date on the most relevant evidence on osteoporosis  in older people living in RACFs grade d according to its level , quality , and relevance . CONCLUSION As with the first consensus , it is hoped that this statement will constitute an important guide to aid physicians in their decision making while practicing at RACFs Herbal products are becoming increasingly mainstream . This is not simply a comment on their popularity , but on the level and rigor of scientific research and acceptance by clinical investigators , as well as the attention being paid to these therapeutic options by government bodies . A recent trial published in the Journal of the American Medical Association ( JAMA ) evaluating St. John 's wort for depression demonstrates this shift.1 Several features of this trial are noteworthy . Not only was the trial of rigorous design and published in a highly reputed journal , but it was completed by a group of high profile and experienced US psychiatric research ers who are generally associated with research ing pharmaceuticals . In the past , the quality of trials involving herbal products and other alternative treatment options for psychiatric and other disorders has been criticized.2 Criticisms have included failing to account for biases and confounders , using nonst and ardized products and poor study design . However , in the last 5 years , MEDLINE ( www.ncbi.nlm.nih.gov/ PubMed ) has indexed over 50 r and omized controlled trials ( RCTs ) investigating complementary medicines for treating mental disorders , suggesting that an increasing number of alternative approaches are being tested using what is approaching gold st and ard methods . This number is likely an underestimate because MEDLINE search strategies , even those devised by experts , can fail to locate a significant number of relevant trials.3 It is also well recognized that MEDLINE does not index all relevant journals in the area of complementary medicines.4 The Cochrane Controlled Trials Register of the Cochrane Library ( www.cochranelibrary.com ) , which lists clinical trials that have been identified through regular search ers of MEDLINE , EMBASE and h and search es of clinical journals , is considered an authoritative source of RCTs .5 For illustrative purpose s only , a selection of RCTs from the Cochrane Library of herbal products used for psychiatric indications is listed in Table 1.1,6,7,8,9,10,11,12,13 Table 1 Considering that the amount of good- quality research regarding herbals in psychiatric disorders appears to be exp and ing steadily , treatment review s , unless up date d regularly , quickly become out date d and serve a limited purpose . Such review s are also not particularly useful for making individual patient treatment decisions ; they tend not to address specific clinical questions adequately , but rather , provide the reader with a general awareness of the topic . As such , this paper is not intended to comprehensively review the benefits and risks of herbal products commonly used for psychiatric disorders . Recent examples of such review s can be found elsewhere.14,15,16,17 Instead , the purpose of this review is to present the steps involved in taking an evidence -based approach to clinical decision making regarding the use of herbal products in psychiatry . The reader will be oriented to the evidence -based process using examples of herbal product use for mental disorders . Methods and tools that facilitate rapid access to the best clinical research about herbal products will be presented . In addition , special issues concerning herbal therapies that differ from the evaluation of pharmaceutical products will be introduced and discussed BACKGROUND The increasing complexity of psychiatric research , including recent attempts to evaluate mental health legislation , suggests legal advice may be valuable in a wide range of research context s. AIMS We aim to illustrate both the legal pitfalls of research in psychiatry and the potential for solutions if the methods are carefully chosen . METHOD Two examples of research are subject to legal analysis , one involving advance directives , the other the r and om discharge of compulsory out- patients .  RESULTS This analysis illustrates that participation in research may expose  clinicians  to additional forms of liability , but the legal risks can be minimised through changes in the methods or additional safeguards . CONCLUSIONS Collaboration between academic law and psychiatry can enrich research agendas and avoid serious legal pitfalls . We argue that sound legal advice should be sought at the planning stage of research in psychiatry , but the fear of liability should not lead to overly defensive research practice s. The aim should be to strike the right balance between avoiding unacceptable exposure to liability and stifling innovative research To determine if teaching caregivers behavior management techniques ( BMTs ) reduces long-term psychotropic use in Alzheimer 's disease ( AD ) patients , we examined 12-month follow-up data from a 4-month r and omized study com paring placebo , BMTs , trazodone , and haloperidol for the treatment of  agitated behaviors in persons with AD . After 4 months , treatment was allowed with any agent . Between 42.8 % and 51 % of AD patients received additional psy chotropics between 4 and 12 months . The relative risk of being prescribed any psychotropic drug after the 4-month trial was at or about 1.0 for subjects in each drug arm or placebo arm versus BMTs . We concluded that teaching  caregivers BMTs did not diminish long-term prescription of psychotropic drugs . ( J Geriatr Psychiatry Neurol 2002 ; 15:95 - 98 ) The role of pharmacotherapy in the management of  severe aggressive behavior in children is review ed . An overview of the relevant literature , a discussion of method ological issues , and a description of a pilot study of the comparative efficacy of lithium , haloperidol , and chlorpromazine are presented . It is concluded that this area has not been studied systematic ally and that , in the future , research must be directed toward assessing the value of current and new pharmacological agents by using well-defined patient population s and attempting to identify subgroups of responders and nonresponders . Equally important are studies concerned with an evaluation of pharmacotherapy combined with psychosocial treatments . Lithium and haloperidol appear worthy of critical examination as adjuncts in the treatment of children for whom the long-term prognosis is poor . Journal of the American Academy of Child Psychiatry , 21 , 2:107–117 , 1982 Cardiovascular disease remains the primary cause of mortality , and a major cause of disability in the developed world.1 This significant burden necessitates ongoing improvements in patient management , to minimize the impact of cardiovascular conditions on both patients and healthcare systems . These improvements in cardiovascular care are promoted by an evidence -based approach , shaped by comprehensive clinical guidelines . The scientific basis of recommendations is an important feature of clinical guidelines , and influences the degree to which they are followed in clinical practice .2 Recent studies have assigned the highest evidence grading to r and omized controlled trials ( RCTs ) that are clinical ly important , and representative of the clinical population covered by the guideline recommendation .3 For example , this highest grading was assigned to a recommendation based on a meta- analysis of RCTs showing low-dose diuretics to be the most effective first-line treatment for cardiovascular event prevention in hypertensive patients . This study review ed data from 42 RCTs which were , crucially , representative of the population that the recommendation was made for ( i.e. hypertensive patients ) .3,4 The importance of the applicability of evidence to recommendations highlights the need to consider evidence from clinical ly relevant situations , not all of which have been assessed by RCTs . This evidence can originate from expert consensus , as well as non-r and omized prospect i ve studies . Although generally providing a lower evidence -level than RCTs , 3,5 observational studies can make an important contribution to the evidence base when the study outcomes are clinical ly important , and the population s involved are representative . Indeed , information from several registries was considered in the recent American Heart Association Acute Coronary Care in the Elderly Scientific Statement.6 Non-r and omized prospect i ve registries document the treatment and outcomes for consecutive patients in clinical practice . Therefore , data are gained from a ‘ real-world ’ selection of patients , many of whom would be excluded from RCTs , OBJECTIVE To describe the Psychiatric Emergency Research Collaboration ( PERC ) , the methods used to create a structured chart review tool and the results of our multicenter study . METHOD Members of the PERC Steering Committee created a structured chart review tool design ed to provide a comprehensive picture of the assessment and management of psychiatric emergency patients . Ten primary indicators were chosen based on the Steering Committee 's professional experience , the published literature and existing consensus panel guidelines . Eight emergency departments completed data abstract ion of 50 r and omly selected emergency psychiatric patients , with seven providing data from two independent raters . Inter-rater reliability ( Kappas ) and descriptive statistics were computed . RESULTS Four hundred patient charts were abstract ed . Initial concordance between raters was variable , with some sites achieving high agreement and others not . Reconciliation of discordant ratings through re- review of the original source documentation was necessary for four of the sites . Two hundred eighty-five ( 71 % ) subjects had some form of laboratory test performed , including 212 ( 53 % ) who had urine toxicology screening and 163 ( 41 % ) who had blood alcohol levels drawn . Agitation was present in 220 ( 52 % ) , with 98 ( 25 % ) receiving a medication to reduce agitation and 22 ( 6 % ) being physically restrained . Self-harm ideation was present in 226 ( 55 % ) , while other-harm ideation was present in 82 ( 20 % ) . One hundred seventy-nine ( 45 % ) were admitted to an inpatient or observation unit . CONCLUSION Creating a common st and ard for documenting , abstract ing and reporting on the nature and management of psychiatric emergencies is feasible across a wide range of health care institutions In this report , which is an up date of a guideline published in 2002 ( B and elow et al. 2002 , World J Biol Psychiatry 3:171 ) , recommendations for the pharmacological treatment of anxiety disorder , obsessive-compulsive disorder ( OCD ) and post-traumatic stress disorder ( PTSD ) are presented . Since the publication of the first version of this guideline , a substantial number of new r and omized controlled studies of anxiolytics have been published . In particular , more relapse prevention studies are now available that show sustained efficacy of anxiolytic drugs . The recommendations , developed by the World Federation of Societies of Biological Psychiatry ( WFSBP ) Task Force for the Pharmacological Treatment of Anxiety , Obsessive-Compulsive and Post-traumatic Stress Disorders , a consensus panel of 30 international experts , are now based on 510 published r and omized , placebo- or comparator-controlled clinical studies ( RCTs ) and 130 open studies and case reports . First-line treatments for these disorders are selective serotonin reuptake inhibitors ( SSRIs ) , serotonin-noradrenaline reuptake inhibitors ( SNRIs ) and the calcium channel modulator pregabalin . Tricyclic antidepressants ( TCAs ) are equally effective for some disorders , but many are less well tolerated than the SSRIs/SNRIs . In treatment-resistant cases , benzodiazepines may be used when the patient does not have a history of substance abuse disorders . Potential treatment options for patients unresponsive to st and ard treatments are described in this overview . Although these guidelines focus on medications , non-pharmacological were also considered . Cognitive behavioural therapy ( CBT ) and other variants of behaviour therapy have been sufficiently investigated in controlled studies in patients with anxiety disorders , OCD , and PTSD to support them being recommended either alone or in combination with the above medicines Not enough fluid and too much fluid are both bad . That is the one great irrefutable truth in fluid management in anaesthesia and in the critically ill . For almost every other question in fluid therapy there is ‘ current opinion ’ . The big questions are when , where , which and why but of greater moment than all of these is ‘ how much ’ . The current drift towards the use of smaller volumes of fluid in major surgery suggests that the right amount at the right time is probably the way to go , so volume and timing are seemingly linked . This ties in neatly with the rediscovery of the notion that early fluid resuscitation in the emergency room is better than late and dovetails with the concept that adequate resuscitation , or optimisation , improves outcome in high risk surgery . New gadgets that help to achieve this end abound since the pulmonary artery catheter fell from grace . The recent discovery of hyperchloraemic acidosis as a new iatrogenic disease entity has focused attention on the importance of the fundamental constituents of the fluids that are given [ 1 ] . The meta-analytical cloud that the Cochrane collaboration placed over albumin was dissipated by the SAFE study only to be replaced by a different evidential cloud drifting over the world of starches [ 2 ] . This has reawakened interest in the potentially malevolent nature of synthetic molecules . As the dynamics of the questions and current answers change , it is easy to become confused . The publication of the British Consensus Guidelines on Intravenous Fluid Therapy for Adult Surgical Patients could therefore not be more timely [ 3 ] . The authors have asked a very large number of relevant questions , assessed a vast array of available information and measured it with an evidence -based score to produce recommendations bundled into guidelines . There are no less than 28 evidence -scored recommendations to assist in fluid management . This major work should be m and atory reading for anyone involved in fluid management for a range of reasons that will come clear . The recommendations , all 28 of them , each has an evidence level of between 1 and 5 , although some have several evidence levels for different parts of the same question . In brief ; level 1 is very good , 1a – a systematic review or 1b a r and omised control trial , while level 4 is a case series and level 5 is expert opinion without critical appraisal , so ‘ 1 – good and 5 – bad ’ . The first recommendation dismisses normal saline from routine use because it causes hyperchloraemic acidosis , and advocates balanced solutions . The evidence level is 1b and appears to be very good using no fewer than seven papers . On closer scrutiny some of these are small r and omised controlled trials which demonstrate mild acidosis [ 4–9 ] . Saline and hyperchloraemic acidosis are associated and by implication this is harmful , although any evidence for harm is circumstantial and inconsequential [ 10 ] . The recommendation , supportive of balanced solutions , is inappropriate given the limited evidence ( this author ’s opinion – level 5 ) . Sensible maybe , but evidence -based ? To be fair , many of the recommendations have been st and ard practice for years and , paradoxically , several of these are level 5 . The pre-operative recommendations may raise eyebrows . Most anaesthetists know that fluids can be given orally up to 2 h pre-operatively but how many actively encourage it despite the evidence level of 1a ? The implication is there should be a general and active move to 2-h fluid fasting . These guidelines are based on three references , two of which are themselves guidelines and one being a Cochrane review . The fact that fluids make patients feel better is supported by trials and rates an evidence level of 2a . Curiously , the guidelines contain useful tips on the current position of bowel preparation , grade d level 1a , while the predicted fluid and electrolyte disturbance which it causes only achieves level 5 . Mind you , using a parachute when jumping out of an aircraft presumably only gets a score of 4 [ 11 ] . It is curious that the Geigy Scientific tables for the electrolyte content of secretions rates level 5 while the Hartmann ’s vs saline question in the replacement of gastric losses rates level 2a , again largely because saline is associated with hyperchloraemic acidosis . No-one would argue that balanced crystalloid or a colloid can be used for the treatment of hypovolaemia but , of the 11 references quoted , nine involve starches , a curious selection from a very extensive literature , while balanced crystalloid is once again recommended because of the supposed risks of hyperchloraemic acidosis , if such risks exist . The recommendations move on to the diagnosis of hypovolaemia and the use of incremental 200-ml boluses of either crystalloid or colloid . This is level 1b evidence based on two small trials [ 12 , 13 ] . While one must question whether this constitutes substantial evidence , it does make sense . Orthopaedic and abdominal surgery are singled out to recommend stroke volume measurement to guide fluid management peri-operatively ( level 1b ) . In orthopaedic surgery this is based on two well known studies , each of which can be interpreted either to indicate that the intervention reduced hospital stay or that the control group could have been better managed . The former is more widely accepted . In non-elective surgery , in the same specialities , this management should continue for 8 h and , in these circumstances , low dose dopexamine , which performed well in a meta- analysis , is Anaesthesia , 2009 , 64 , pages 235–238 These guidelines for the biological treatment of schizophrenia were developed by an international Task Force of the World Federation of Societies of Biological Psychiatry ( WFSBP ) . The goal during the development of these guidelines was to review systematic ally all available evidence pertaining to the treatment of schizophrenia , and to reach a consensus on a series of practice recommendations that are clinical ly and scientifically meaningful based on the available evidence . These guidelines are intended for use by all physicians seeing and treating people with schizophrenia . The data used for developing these guidelines have been extracted primarily from various national treatment guidelines and panels for schizophrenia , as well as from meta-analyses , review s and r and omised clinical trials on the efficacy of pharmacological and other biological treatment interventions identified by a search of the MEDLINE data base and Cochrane Library . The identified literature was evaluated with respect to the strength of evidence for its efficacy and then categorised into four levels of evidence ( A – D ) . This first part of the guidelines covers disease definition , classification , epidemiology and course of schizophrenia , as well as the management of the acute phase treatment . These guidelines are primarily concerned with the biological treatment ( including antipsychotic medication , other pharmacological treatment options , electroconvulsive therapy , adjunctive and novel therapeutic strategies ) of adults suffering from schizophrenia OBJECTIVES Depression in older patients contributes to personal suffering and family disruption and increases disability , medical morbidity , mortality , suicide risk , and healthcare utilization . The majority of clinical trials of antidepressant treatments are conducted in younger patients . For this reason , clinicians often have to extrapolate from studies in population s that do not present the same problems as older patients . For example , older patients often have serious coexisting medical conditions that may contribute to the depression and complicate the choice of treatment . Older patients as a rule need to be on many medications , some of which may contribute to depression and /or interact with antidepressants . Finally , older adults metabolize medications slowly and are more sensitive to side effects than younger patients . Because of these complexities , we conducted a consensus survey of expert opinion on the pharmacotherapy of depressive disorders in older patients to address clinical questions not definitively answered in the research literature . METHOD After review ing the literature and convening a work group of experts , we prepared a written survey with 64 questions that asked about 857 options . 618 of the options were scored using a modified version of the R AND 9-point scale for rating appropriateness of medical decisions . For the other options , the experts were asked to write in answers ( e.g. , average doses ) or to check a box to indicate their preferred answer . We sent the survey to 50 national experts on geriatric depression , all of whom completed it . Consensus on each option was defined as a nonr and om distribution of scores by chi-square " goodness-of-fit " test . We assigned a categorical rank ( first line/preferred choice , second line/alternate choice , third line/usually inappropriate ) to each option based on the 95 % confidence interval around the mean rating . Guideline tables indicating preferred treatment strategies were then developed for key clinical situations . RESULTS The expert panel reached consensus on 89 % of the options rated on the 9-point scale . The experts stress the importance of identifying coexisting medical conditions that may be contributing to the depression or complicate treatment . For unipolar nonpsychotic major depression , the preferred strategy is an antidepressant ( selective serotonin reuptake inhibitor [ SSRI ] or venlafaxine XR preferred ) plus psychotherapy . For unipolar psychotic major depression , the treatment of choice is an antidepressant ( SSRI or venlafaxine XR ) plus one of the newer atypical antipsychotics . Electroconvulsive therapy is also first line . For dysthymic disorder or persistent milder depression , the experts recommend combining an antidepressant ( SSRIs preferred ) and psychotherapy . If the patient has a comorbid medical condition ( e.g. , hypothyroidism ) that is contributing to the depression , the experts recommend treating both the depression and the medical condition from the outset . The SSRIs were the top-rated antidepressants for all types of depression . Among them , the experts gave the highest ratings for efficacy and tolerability to citalopram and sertraline . Paroxetine was another first-line option , and fluoxetine was rated high second line . The preferred psychotherapy techniques for treating depression in older patients are cognitive-behavioral therapy , supportive psychotherapy , problem-solving psychotherapy , and interpersonal psychotherapy . The experts also give strong support to including appropriate psychosocial interventions ( e.g. , psychoeducation , family counseling , visiting nurse services ) in the treatment program . The majority of experts would continue treatment with antidepressant medication for at least 1 year if a patient has had a single episode of severe unipolar major depression , for 1 - 3 years for a patient who has had 2 such episodes , and for longer than 3 years if there is a history of 3 or more episodes . CONCLUSIONS The experts reached a high level of consensus on the appropriateness of including both antidepressant medication , specifically SSRIs , and nonpharmacological modalities in treatment plans for severe depression . Within the limits of expert opinion and with the expectation that future research data will take precedence , these guidelines provide direction for addressing common clinical dilemmas in older individuals . They can be used to inform clinicians and educate patients regarding the relative merits of a variety of interventions . Nonetheless , the guidelines can not address the complexities involved in the care of each individual patient and can be most helpful in the h and s of experienced clinicians BACKGROUND The relationship between psychomotor agitation in unipolar depression and mood-switching from depression to manic , hypomanic and mixed states has been controversial . We investigated the future risk of initial mood-switching as a function of psychomotor agitation in unipolar depression . METHODS We identified 189 participants diagnosed with major depressive disorder ( MDD ) . We divided all patients with MDD into two categories ( 1 ) agitated patients ( n=74 ) , and ( 2 ) non-agitated patients ( n=115 ) . These groups were prospect ively followed and compared by time to mood-switching . Kaplan-Meier survival curves , log-rank test for trend for survivor functions , and Cox proportional hazard ratio estimates for a multivariate model were conducted to examine the risk of mood-switching by psychomotor agitation . RESULTS During follow-up , mood-switching occurred in 20.3 % of the agitated patients and 7.0 % of the non-agitated patients . In the Kaplan-Meier survival estimates for time to incidence of mood-switching with agitated or non-agitated patients , the cumulative probability of developing mood-switching for agitated patients was higher than those for non-agitated patients ( log-rank test : χ(2)=7.148 , df=1 , p=0.008 ) . Survival analysis was also performed using Cox proportional hazards regression within a multivariate model . The agitation remained significantly associated with incidence of mood-switching ( HR=2.98 , 95 % CI : 1.18 - 7.51 ) . LIMITATIONS We did not make a clear distinction between antidepressant-induced mood-switching and spontaneous switching . CONCLUSIONS The main finding demonstrated that MDD patients with agitation were nearly threefold as likely to experience mood-switching , suggesting that psychomotor agitation in MDD may be related to an indicator of bipolarity Objective To compare the effect of intramuscular olanzapine with intramuscular haloperidol plus promethazine on rapid tranquillisation of agitated or violent people with mental illness .  Design Pragmatic , allocation concealed , r and omised controlled trial . Setting Emergency services of a general hospital psychiatry department in Vellore , south India . Participants 300 adults with agitated or violent behaviour as a result of mental illness ; 150 r and omised to intramuscular olanzapine and 150 r and omised to intramuscular haloperidol plus promethazine .  Interventions Open treatment with intramuscular olanzapine or intramuscular haloperidol plus promethazine . Main outcome measures Primary outcome was proportion of patients who were tranquil or asleep at 15 minutes and 240 minutes . Secondary outcomes were proportion of patients who were tranquil , asleep , restrained , absconding , or clinical ly improved at 15 , 30 , 60 , 120 , and 240 minutes ; additional medical interventions and adverse effects over four hours ; and compliance with oral drugs and adverse effects over two weeks . Results Of 300 people r and omised to receive either intramuscular olanzapine or intramuscular haloperidol plus promethazine , follow-up data were available for primary outcomes for 298 ( 99 % ) . Both treatments result ed in similar proportions of people being tranquil or asleep at 15 minutes ( olanzapine 131/150 ( 87 % ) , haloperidol plus promethazine 136/150 ( 91 % ) ; relative risk 0.96 , 95 % confidence interval 0.34 to 1.47 ) and 240 minutes ( olanzapine 144/150 ( 96 % ) , haloperidol plus promethazine 145/150 ( 97 % ) ; relative risk 0.99 , 0.95 to 1.03 ) . However , more people given olanzapine than those given haloperidol plus promethazine required additional drugs over four hours ( 65/150 ( 43 % ) v 31/150 ( 21 % ) ; relative risk 2.07 , 1.43 to 2.97 ) . Adverse effects were uncommon with both treatments . Conclusions Intramuscular olanzapine and intramuscular haloperidol plus promethazine were effective at rapidly tranquillising or sedating agitated or violent  patients with mental illness but the combination result ed in fewer additional medical interventions within four hours of intervention . Trial registration Clinical trials NCT00455234 OBJECTIVE To review published literature regarding aripiprazole in child and adolescent psychiatry . METHOD A literature review was conducted using the medline search term : ' aripiprazole ' with limits : Human trials , English language , All Child ( aged 0 - 18 years ) . Additional articles were identified from reference information and poster presentation data . RESULTS Aripiprazole is an atypical antipsychotic which was recently approved for use in Canada , but has been available for several years in the United States . Pharmacologically , aripiprazole is a partial agonist at D(2 ) and 5-HT(1A ) receptors and an antagonist at 5-HT(2A ) receptors . R and omized controlled trial data is available showing efficacy for aripiprazole in the treatment of children and adolescents with schizophrenia , bipolar disorder and behavioural problems associated with autism . Open-label evidence is also available for use of aripiprazole in other disorders such as tic disorders , aggression and disruptive behavior disorders . Unlike some other available atypical antipsychotics , there does not appear to be any effect on QTc interval on the electrocardiogram . Adverse effects including extrapyramidal symptoms ( EPS ) , akathisia , sedation , headache , nausea were significant in clinical trials in children and adolescents . The possibility of aripiprazole causing tardive dyskinesia can not be excluded . In this population , aripiprazole appears to have minimal impact on the metabolic profile compared to most other atypical antipsychotics , with minimal changes in weight or body mass index , no significant changes in glucose or lipid metabolism , and a decrease in serum prolactin . CONCLUSION Aripiprazole may represent an important alternative for some children and adolescents who have experienced poor efficacy or significant metabolic adverse effects with their current antipsychotic treatment regimen Among the more than 20 million Americans who have diabetes , approximately 30 % of the cases are undiagnosed ( 1 ) . An additional 42 million people in the United States have pre-diabetes ( impaired glucose tolerance [ IGT ] , impaired fasting glucose , or both ) , a condition that often leads to diabetes if it is not treated ( 1 ) . The dramatic 41 % increase in prevalence of diabetes during the 1990s was characterized by a shift to a younger age at onset . The prevalence of diabetes increased more than 70 % in the age-group 30 to 39 years ( 1 ) . The longer the duration of poorly controlled diabetes , the greater the risk for development of vascular complications , including retinopathy , end-stage kidney disease , neuropathy , and coronary artery disease . These complications are not only debilitating but also expensive . In 2002 , health-care costs for diabetes in the United States surpassed $ 132 billion ( 1 ) . These costs were primarily related to the treatment and consequences of complications of diabetes ( 2 ) . Several large prospect i ve studies have shown that intensive treatment of diabetes can decrease the chronic complications associated with this disease ( 3 - 6 ) . There seems to be no glycemic threshold for reduction of complications ; the lower the hemoglobin A1c ( A1C ) level , the lower the rate of occurrence of diabetes-related complications ( 7 ) . Advances in pharmacologic therapies and new treatment technologies can facilitate reduction of blood glucose values in patients with diabetes to near-normal and achieve glycemic goal levels recommended in current practice guidelines . Nevertheless , the management of patients with diabetes in the United States has actually worsened during the past decade ( 8) . Data from the National Health and Nutrition Examination Survey III in 1994 showed that only 44 % of patients with type 2 diabetes achieved an A1C level of less than 7 % ( 9 ) . By the year 2000 , this proportion actually decreased to 37 % ( 10 ) . Recently , at an American Association of Clinical Endocrinologists ( AACE ) meeting , a report on the state of diabetes health showed that , in a study of 157,000 Americans in 39 states , two-thirds of the subjects with type 2 diabetes had A1C values above the American College of Endocrinology ( ACE ) goal for glycemic control of 6.5 % or less ( American College of Endocrinology/ American Association of Clinical Endocrinologists . State of Diabetes in America : Striving for Better Control . Available at : http://www.aace.com/pub/StateofDiabetes/ stateofdiabetes.php ) . Clearly , more aggressive and comprehensive application of these available treatment options , supported by diabetes education , is needed . On January 31 , 2005 , ACE and AACE convened a 2day consensus conference to review current research and address questions relevant to the treatment of diabetes . The conference brought together US and international diabetes research ers , clinical and educational experts , and ACE/AACE CONSENSUS CONFERENCE ON THE IMPLEMENTATION OF OUTPATIENT MANAGEMENT OF DIABETES MELLITUS : CONSENSUS CONFERENCE Background / Aims : Behavioural and psychological symptoms ( BPSD ) are frequent in people with Alzheimer ’s disease and cause considerable stress to patients and their carers . Antipsychotics have been widely used as a first-line treatment , result ing in an estimated 1,800 excess strokes and 1,600 excess deaths in the UK alone . Safe and effective alternatives are urgently needed . Based upon preliminary evidence from clinical trials , aromatherapy with melissa oil may be such an alternative , but initial studies have been modest in size , and adequate blinding has been problematic . Our objective was to assess the efficacy of melissa aromatherapy in the treatment of agitation in people with Alzheimer ’s disease in an adequately powered and robustly blinded r and omized controlled trial comparing it with donepezil , an anticholinesterase drug used with some benefit to treat BPSD . Methods and Findings : The study was a double-blind parallel-group placebo-controlled r and omized trial across 3 specialist old age psychiatry centres in Engl and . Participants had probable or possible Alzheimer ’s disease , were resident in a care home , had clinical ly significant agitation ( defined as a score of 39 or above on the Cohen Mansfield Agitation Inventory ) and were free of antipsychotics and /or anticholinesterase for at least 2 weeks . Participants were allocated to 1 of 3 groups : placebo medication and active aromatherapy ; active medication and placebo aromatherapy or placebo of both . Main Outcome : The primary outcome measure was reduction in agitation as assessed by the Pittsburgh Agitation Scale ( PAS ) at 4 weeks . This is an observational scale , and raters were required to wear nose clips to ensure that full blinding was maintained . The PAS , Neuropsychiatric Inventory ( NPI ; another measure of BPSD ) and other outcome measures were completed at baseline , 4-week and 12-week follow-ups . 114 participants were r and omized , of whom 94 completed the week 4 assessment and 81 completed the week 12 assessment . Aromatherapy and donepezil were well tolerated . There were no significant differences between aromatherapy , donepezil and placebo at week 4 and week 12 , but importantly there were substantial improvements in all 3 groups with an 18 % improvement in the PAS and a 37 % improvement in the NPI over 12 weeks . Conclusion : When assessed using a rigorous design which ensures blinding of treatment arms , there is no evidence that melissa aromatherapy is superior to placebo or donepezil , in the treatment of agitation in people with Alzheimer ’s disease . However , the sizeable improvement in the placebo group emphasizes the potential non-specific benefits of touch and interaction in the treatment of agitation in people with Alzheimer ’s disease Abstract Objectives . This 2013 up date of the practice guidelines for the biological treatment of unipolar depressive disorders was developed by an international Task Force of the World Federation of Societies of Biological Psychiatry ( WFSBP ) . The goal has been to systematic ally review all available evidence pertaining to the treatment of unipolar depressive disorders , and to produce a series of practice recommendations that are clinical ly and scientifically meaningful based on the available evidence . The guidelines are intended for use by all physicians seeing and treating patients with these conditions . Methods . The 2013 up date was conducted by a systematic up date literature search and appraisal . All recommendations were approved by the Guidelines Task Force . Results . This first part of the guidelines ( Part 1 ) covers disease definition , classification , epidemiology , and course of unipolar depressive disorders , as well as the management of the acute and continuation phase treatment . It is primarily concerned with the biological treatment ( including antidepressants , other psychopharmacological medications , electroconvulsive therapy , light therapy , adjunctive and novel therapeutic strategies ) of adults . Conclusions . To date , there is a variety of evidence -based antidepressant treatment options available . Nevertheless there is still a substantial proportion of patients not achieving full remission . In addition , somatic and psychiatric comorbidities and other special circumstances need to be more thoroughly investigated . Therefore , further high- quality informative r and omized controlled trials are urgently needed OBJECTIVE To determine the incidence and causes of agitation states in patients presenting at the Rouen University Hospital emergency room and to analyze the management scheme . PATIENTS AND METHOD A prospect i ve study was conducted over a 9 month period in 100 consecutive patients presenting a state of agitation assessed using the Overt Aggression Scale . A pre-planned management protocol was applied . RESULTS The incidence of states of agitation was 0.56 % . There were 43 women and 57 men , mean age 33 years . Most of the agitated patients were admitted between 6 p.m. and 4 a.m. ( 69 % ) . Over the 9 month period , 2 patients were admitted twice for agitation and 2 absconded . Low glucose level was the cause of agitation in 4 cases . Alcohol and /or drug use concerned 73 % of the agitated patients and was the most frequently observed triggering factor ( 17 % ) . Only 6 % of the patients had a regular employment . Physical restraining measures and sedation were required in 86 % and 84 % of the cases respectively . Among 67 patients given loxapine for sedation , 2 developed acute dyskinesia and 9 low blood pressure . One out of 4 patients were referred to a psychiatric unit . CONCLUSION Patients in a state of agitation are young , often female , and in a difficult socio-economic situation . Hypoglycemia is the main differential diagnosis . A triggering factor can often be identified . A state of agitation is not a repetitive condition but occurs as a short-lived episode in the patientís history . Such patients need rapid care to avoid further aggravation and disruption of the emergency room activity , and to prevent the patient from fleeing . Loxapine provides effective sedation but requires regular monitoring of blood pressure and can provoke acute dyskinesia in young subjects OBJECTIVES A growing number of atypical antipsychotics are available for clinicians to choose from in the treatment of psychotic disorders . However , a number of important questions concerning medication selection , dosing and dose equivalence , and the management of inadequate response , compliance problems , and relapse have not been adequately addressed by clinical trials . To aid clinical decision-making , a consensus survey of expert opinion on the pharmacologic treatment of psychotic disorders was undertaken to address questions not definitively answered in the research literature . METHOD Based on a literature review , a written survey was developed with 60 questions and 994 options . Approximately half of the options were scored using a modified version of the R AND 9-point scale for rating the appropriateness of medical decisions . For the other options , the experts were asked to write in answers ( e.g. , average doses ) or check a box to indicate their preferred answer . The survey was sent to 50 national experts on the pharmacologic treatment of psychotic disorders , 47 ( 94 % ) of whom completed it . In analyzing the responses to items rated on the 9-point scale , consensus on each option was defined as a non r and om distribution of scores by chi-square " goodness-of-fit"test . We assigned a categorical rank ( first line/preferred choice , second line/alternate choice , third line/usually inappropriate ) to each option based on the 95 % confidence interval around the mean rating . Guideline tables indicating preferred treatment strategies were then developed for key clinical situations . RESULTS The expert panel reached consensus on 88 % of the options rated on the 9-point scale . The experts overwhelmingly endorsed the atypical antipsychotics for the treatment of psychotic disorders . Risperidone was the top choice for first-episode and multi-episode patients , with the other newer atypicals rated first line or high second line depending on the clinical situation . Clozapine and a long-acting injectable atypical ( when available)were other high second line options for multi-episode patients . The expert 's dosing recommendations agreed closely with the package inserts for the drugs , and their estimates of dose equivalence among the antipsychotics followed a linear pattern . The experts considered 3 - 6 weeks an adequate antipsychotic trial , but would wait a little longer ( 4 - 10 weeks ) before making a major change in treatment regimen if there is a partial response . The experts recommended trying to improve response by increasing the dose of atypical and depot antipsychotics before switching to a different agent ; there was less agreement about increasing the dose of conventional antipsychotics before switching , probably because of concern about side effects at higher doses . If it is decided to switch because of inadequate response , risperidone was the expert 's first choice to switch to , no matter what drug was initially tried . Although there was some disparity in the expert 's recommendations concerning how many agents to try before switching to clozapine , the expert 's responses suggest that switching to clozapine should be Clozapine was also the antipsychotic of choice for patients with suicidal behavior . When switching oral antipsychotics , the experts considered cross-titration the preferred strategy . When switching to an injectable antipsychotic , the experts stressed the importance of continuing the oral antipsychotic until therapeutic levels of the injectable agent are achieved . The experts considered psychosocial interventions the first choice strategy for partially compliant patients , with pharmacologic interventions the first choice for patients with clear evidence of noncompliance . However , because it can be difficult to distinguish partially compliant from noncompliant patients , the editors recommended combining psychosocial and pharmacologic interventions to improve compliance whenever possible . When patients relapse because of compliance problems or if there is any doubt about compliance , the experts recommended the use of a long-acting injectable antipsychotic and would select an injectable atypical when this option becomes available . The experts would also consider using an injectable atypical antipsychotic ( when available ) in many clinical situations that do not involve compliance problems . The experts stressed the importance of monitoring for health problems-especially obesity , diabetes , cardiovascular problems , HIV risk behaviors , medical complications of substance abuse , heavy smoking and its effects , hypertension , and amenorrhea-in patients being treated with antipsychotics . Although many patients are prescribed adjunctive treatments , multiple antipsychotics , and combinations of different classes of drugs ( e.g. , antipsychotics plus mood stabilizers or antidepressants ) in an effort to enhance response , the experts gave little support to any of these strategies , with the exception of antidepressants for patients with  dysphoria/depression  , antidepressants or ECT for patients with suicidal behavior , and mood stabilizers for patients with aggression/violence . When asked about indicators of remission and recovery , the experts considered acute improvement in psychotic symptoms the most important indicator of remission , whereas they considered more sustained improvement in multiple outcome domains ( e.g. , occupational/educational functioning , peer relationships , independent living ) important in assessing recovery . CONCLUSIONS The experts reached a high level of consensus on many of the key treatment questions in the survey . Within the limits of expert opinion and with the expectation that future research data will take precedence , these guidelines provide direction for addressing common clinical dilemmas that arise in the pharmacologic treatment of psychotic disorders . They can be used to inform clinicians and educate patients regarding the relative merits of a variety of interventions . Clinicians should keep in mind that no guidelines can address the complexities involved in the care of each individual patient and that sound clinical judgment based on clinical experience should be used in applying these recommendations OBJECTIVE To test cognitive-behavioral therapy for insomnia ( CBT-I ) in patients who not only receive psychiatric treatment in a outpatient psychiatry clinic but also continue to experience chronic insomnia despite receiving pharmacological treatment for sleep . CBT-I included an optional module for discontinuing hypnotic medications . METHOD Patients were r and omized to 5 sessions of individual CBT-I ( n = 13 ) or treatment as usual ( n = 10 ) .  Sleep parameters were assessed using  sleep diaries  at pre- and posttreatment . Question naires measuring depression , anxiety , and health-related quality of life were also administered . RESULTS CBT-I was associated with significant improvement in sleep , with 46 % obtaining normal global sleep ratings after treatment . However , no changes in secondary outcomes ( depression , anxiety , quality of life ) were obtained and no patients elected to discontinue their hypnotic medications . CONCLUSIONS Patients with complex , chronic psychiatric conditions can obtain sleep improvements with CBT-I beyond those obtained with pharmacotherapy alone ; however , sleep interventions alone may not have the same effect on mental health outcomes in sample s with more severe and chronic psychiatric symptoms and dependency on hypnotic medications OBJECTIVE to ascertain the value of employing a specialist clinician 's contribution to the assessment of older people prior to care home entry . DESIGN r and omised controlled trial . METHOD 256 older people at risk of care home entry were r and omly allocated to either a control group , who received the usual care management assessment , or to an experimental group who , in addition , received a clinical assessment by a geriatrician or old age psychiatrist . The value of the additional assessment was evaluated by an analysis of clinical recommendations , question naires eliciting the views of stakeholders and research interviews with older people and their carers at initial assessment and 6 months . Data on service use and costs over 6 months and on destination at 6 and 12 months were also collected . RESULTS the clinical assessment uncovered covert morbidity previously unknown to care managers particularly in respect of cognitive impairment and was adjudged acceptable to the different stakeholders involved . Those receiving the clinical assessment experienced less deterioration in their physical functioning , had less contact with nursing homes and emergency services and their carers experienced reduced levels of distress . Overall , the costs of care for those receiving the assessment were no greater with NHS costs actually lower . CONCLUSIONS the potential benefits in involving specialist clinicians in the assessment process include identifying previously undiagnosed conditions and enhancing care managers ' decision making . Such an assessment could be provided at a modest marginal cost . The approach is fully compatible with proposals for the role of the community geriatrician and commensurate with current good clinical practice in old age psychiatry Agitation is not only a frequent and disturbing behavior for many patients with dementia , but it also troubles their caregivers and families . Many serious problems and side effects are associated with the use of medications to treat agitation ; therefore , alternative approaches to treating agitation must be assessed . The current article presents results from a quality improvement pilot project that examined the usefulness of a specially design ed , multisensory room intervention for geriatric psychiatric in patients with mild to moderate agitation . Thirty-two visits to the sensory room were made by 13 in patients with dementia . A significant decrease occurred in the Pittsburgh Agitation Scale ( PAS ) total scores over time from pre-room to post-room intervention , as well as 1-hour post-room intervention ( F = 95.3 , p < 0.001 ) . Significant effects were found for all PAS subscales ( i.e. , aberrant vocalizations , motor agitation , and resistance to care ) , with the exception of the aggression subscale . The multisensory room intervention was effective in decreasing some symptoms of agitation in the geriatric psychiatric patient , thus contributing to positive patient , family , and nursing outcomes PURPOSE The aim of this guideline is to present recommendations regarding moderately hypofractionated ( 240 - 340 cGy per fraction ) and ultrahypofractionated ( 500 cGy or more per fraction ) radiation therapy for localized prostate cancer . METHODS AND MATERIAL S The American Society for Radiation Oncology convened a task force to address 8 key questions on appropriate indications and dose-fractionation for moderately and ultrahypofractionated radiation therapy , as well as technical issues , including normal tissue dose constraints , treatment volumes , and use of image guided and intensity modulated radiation therapy . Recommendations were based on a systematic literature review and created using a predefined consensus-building methodology and Society-approved tools for grading evidence quality and recommendation strength . RESULTS Based on high- quality evidence , strong consensus was reached for offering moderate hypofractionation across risk groups to patients choosing external beam radiation therapy . The task force conditionally recommends ultrahypofractionated radiation may be offered for low- and intermediate-risk prostate cancer but strongly encourages treatment of intermediate-risk patients on a clinical trial or multi-institutional registry . For high-risk patients , the task force conditionally recommends against routine use of ultrahypofractionated external beam radiation therapy . With any hypofractionated approach , the task force strongly recommends image guided radiation therapy and avoidance of nonmodulated 3-dimensional conformal techniques . CONCLUSIONS Hypofractionated radiation therapy provides important potential advantages in cost and convenience for patients , and these recommendations are intended to provide guidance on moderate hypofractionation and ultrahypofractionation for localized prostate cancer . The limits in the current evidentiary base-especially for ultrahypofractionation-highlight the imperative to support large-scale r and omized clinical trials and underscore the importance of shared decision making between clinicians and patients Epidemiology and Psychiatric Sciences / Volume 22 / Issue 04 / December 2013 , pp 321 323 DOI : 10.1017/S2045796013000267 , Published online : 12 June 2013 Link to this article : http://journals.cambridge.org/ abstract _ S2045796013000267 How to cite this article : C.E. Adams ( 2013 ) . Many more reasons behind difculties in recruiting patients to r and omized controlled trials in psychiatry . Epidemiology and Psychiatric Sciences , 22 , pp 321 - 323 doi:10.1017/S2045796013000267 Request Permissions : Click d c p B s i R This is one of a series of statements discussing the use of GI endoscopy in common clinical situations . The St and ards of Practice Committee of the American Society for Gastrointestinal Endoscopy ( ASGE ) prepared this text . In preparing this guideline , a search of the medical literature was performed by using PubMed . Additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants . When few or no data exist from well- design ed prospect i ve trials , emphasis is given to results from large series and reports from recognized experts . Guidelines for appropriate use of endoscopy are based on a critical review of the available data and expert consensus at the time that the guidelines are drafted . Further controlled clinical studies may be needed to clarify aspects of this guideline . This guideline may be revised as necessary to account for changes in technology , new data , or other aspects of clinical practice . The recommendations are based on review ed studies and are grade d on the strength of the supporting evidence 1 ( Table 1 ) . he strength of individual recommendations is based on oth the aggregate evidence quality and an assessment of the nticipated benefits and harms . Weaker recommendations re indicated by phrases such as “ We suggest . . . , ” whereas tronger recommendations are typically stated as “ We recmmend . . . . ” This guideline is intended to be an educational device to provide information that may assist endoscopists in providing care to patients . This guideline is not a rule and should not be construed as establishing a legal st and ard of care or as encouraging , advocating , requiring , or discouraging any particular treatment . Clinical decisions in any particular case involve a complex analysis of the patient ’s condition and available courses of action . Therefore , clinical considerations may lead an endoscopist to take a course of action that varies from these guidelines BACKGROUND The pharmacological management of violence in people with psychiatric disorders is under- research ed . AIMS To compare interventions commonly used for controlling agitation or violence in people with serious psychiatric disorders . METHOD We r and omised 200 people to receive intramuscular lorazepam ( 4 mg ) or intramuscular haloperidol  ( 10 mg ) plus promethazine ( 25 - 50 mg mix ) . RESULTS At blinded assessment s 4 h later ( 99.5 % follow-up ) , equal numbers in both groups ( 96 % ) were tranquil or asleep . However , 76 % given the haloperidol-promethazine mix were asleep compared with 45 % of those allocated lorazepam ( RR=2.29,95 % CI 1.59 - 3.39 ; NNT=3.2,95 % CI 2.3 - 5.4 ) . The haloperidol-promethazine mix produced a faster onset of tranquillisation/sedation and more clinical improvement over the first 2 h. Neither intervention differed significantly in the need for additional intervention or physical restraints , numbers absconding , or adverse effects . CONCLUSIONS Both interventions are effective for controlling violent/agitated behaviour . If speed of sedation is required , the haloperidol-promethazine combination has advantages over lorazepam OBJECTIVE To compare the effectiveness of intramuscular olanzapine , ziprasidone , haloperidol plus promethazine , haloperidol plus midazolam and haloperidol alone as the first medication(s ) used to treat patients with agitation and aggressive behavior . METHOD One hundred fifty patients with agitation caused by psychotic or bipolar disorder were r and omly assigned under double-blind conditions to receive olanzapine , ziprasidone , haloperidol plus midazolam , haloperidol plus promethazine or haloperidol alone . The Overt Agitation Severity Scale , Overt Aggression Scale and Ramsay Sedation Scale were applied within 12 hours after the first dosage . RESULTS All medications produced a calming effect within one hour of administration , but only olanzapine and haloperidol reduced agitation by less than 10 points , and only olanzapine reduced aggression by less than four points in the first hour . After twelve hours , only patients treated with haloperidol plus midazolam had high levels of agitation and aggression and also more side effects . Ziprasidone , olanzapine and haloperidol alone had more stable results for agitation control , while ziprasidone , haloperidol plus promethazine and olanzapine had stable results for aggression control . CONCLUSION Olanzapine , ziprasidone , haloperidol plus promethazine , haloperidol plus midazolam and haloperidol were effective in controlling agitation and aggression caused by mental illness over 12 hours . Although all the drugs had advantages and disadvantages , haloperidol plus midazolam was associated with the worst results in all the observed parameters Aim of the study This prospect i ve , controlled trial aim ed to assess the effect of pharmacist-led medication review s on the medication safety of psychiatric in patients by the resolution of Drug-Related Problems ( DRP ) . Both the therapy appropriateness measured with the Medication Appropriateness Index ( MAI ) and the number of unsolved DRP per patient were chosen as primary outcome measures . Methods Depending on their time of admission , 269 psychiatric patients that were admitted to a psychiatric university hospital were allocated in control ( 09/2012 - 03/2013 ) or intervention group ( 05/2013 - 12/2013 ) . In both groups , DRP were identified by comprehensive medication review s by clinical pharmacists at admission , during the hospital stay , and at discharge . In the intervention group , recommendations for identified DRP were compiled by the pharmacists and discussed with the therapeutic team . In the control group , recommendations were not provided except for serious or life threatening DRP . As a primary outcome measure , the changes in therapy appropriateness from admission to discharge as well as from admission to three months after discharge ( follow-up ) assessed with the MAI were compared between both groups . The second primary outcome was the number of unsolved DRP per patient after completing the study protocol . The DRP type , the relevance and the potential of drugs to cause DRP were also evaluated . Results The intervention led to a reduced MAI score by 1.4 points per patient ( 95 % confidence interval [ CI ] : 0.8–2.0 ) at discharge and 1.3 points ( 95 % CI : 0.7–1.9 ) at follow-up compared with controls . The number of unsolved DRP in the intervention group was 1.8 ( 95 % CI : 1.5–2.1 ) less than in control . Conclusion The pharmaceutical medication review s with interdisciplinary discussion of identified DRP appears to be a worthy strategy to improve medication safety in psychiatry as reflected by less unsolved DRP per patient and an enhanced appropriateness of therapy . The promising results of this trial likely warrant further research that evaluates direct clinical outcomes and health-related costs . Trial Registration Deutsches Register Klinischer Studien ( DRKS ) , During the past three decades , catheter and surgical ablation of  atrial fibrillation ( AF ) have evolved from investigational procedures to their current role as effective treatment options for patients with AF .  Surgical ablation of AF , using either st and ard , minimally invasive , or hybrid techniques , is available in most major hospitals throughout the world . Catheter ablation of AF is even more widely available , and is now the most commonly performed catheter ablation procedure . In 2007 , an initial Consensus Statement on Catheter and Surgical AF Ablation was developed as a joint effort of the Heart Rhythm Society ( HRS ) , the European Heart Rhythm Association ( EHRA ) , and the European Cardiac Arrhythmia Society (ECAS).1 The 2007 document was also developed in collaboration with the Society of Thoracic Surgeons ( STS ) and the American College of Cardiology ( ACC ) . This Consensus Statement on Catheter and Surgical AF Ablation was rewritten in 2012 to reflect the many advances in AF ablation that had occurred in the interim.2 The rate of advancement in the tools , techniques , and outcomes of AF ablation continue to increase as enormous research efforts are focused on the mechanisms , outcomes , and treatment of AF . For this reason , the HRS initiated an effort to rewrite and up date this Consensus Statement . Reflecting both the worldwide importance of AF , as well as the worldwide performance of AF ablation , this document is the result of a joint partnership between the HRS , EHRA , ECAS , the Asia Pacific Heart Rhythm Society ( APHRS ) , and the Latin American Society of Cardiac Stimulation and Electrophysiology ( Sociedad Latinoamericana de Estimulacion Cardiaca y Electrofisiologia [ SOLAECE ] ) . The purpose of this 2017 Consensus Statement is to provide a state-of-the-art review of the field of catheter and surgical ablation of AF and to report the findings of a writing group , convened by these five international societies . The writing group is charged with defining the indications , techniques , and outcomes of AF ablation procedures . Included within this document are recommendations pertinent to the design of clinical trials in the field of AF ablation and the reporting of outcomes , including definitions relevant to this topic . The writing group is composed of 60 experts representing 11 organizations : HRS , EHRA , ECAS , APHRS , SOLAECE , STS , ACC , American Heart Association ( AHA ) , Canadian Heart Rhythm Society ( CHRS ) , Japanese Heart Rhythm Society ( JHRS ) , and Brazilian Society of Cardiac Arrhythmias ( Sociedade Brasileira de Arritmias Cardiacas [ SOBRAC ] ) . All the members of the writing group , as well as peer review ers of the document , have provided disclosure statements for all relationships that might be perceived as real or potential conflicts of interest . All author and peer review er disclosure information is provided in Appendix A and Appendix B. In writing a consensus document , it is recognized that consensus does not mean that there was complete agreement among all the writing group members . Surveys of the entire writing group were used to identify areas of consensus concerning performance of AF ablation procedures and to develop recommendations concerning the indications for catheter and surgical AF ablation . These recommendations were systematic ally balloted by the 60 writing group members and were approved by a minimum of 80 % of these members . The recommendations were also subject to a 1-month public comment period . Each partnering and collaborating organization then officially review ed , commented on , edited , and endorsed the final document and recommendations . The grading system for indication of class of evidence level was adapted based on that used by the ACC and the AHA.3,4 It is important to state , however , that this document is not a guideline . The indications for catheter and surgical ablation of AF , as well as recommendations for procedure performance , are presented with a Class and Level of Evidence ( LOE ) to be consistent with what the reader is familiar with seeing in guideline statements . A Class I recommendation means that the benefits of the AF ablation procedure markedly exceed the risks , and that AF ablation should be performed ; a Class IIa recommendation means that the benefits of an AF ablation procedure exceed the risks , and that it is reasonable to perform AF ablation ; a Class IIb recommendation means that the benefit of AF ablation is greater or equal to the risks , and that AF ablation may be considered ; and a Class III recommendation means that AF ablation is of no proven benefit and is not recommended . The writing group review ed and ranked evidence supporting current recommendations with the weight of evidence ranked as Level A if the data were derived from high- quality evidence from more than one r and omized clinical trial , meta-analyses of high- quality r and omized clinical trials , or one or more r and omized clinical trials corroborated by high- quality registry studies . The writing group ranked available evidence as Level B-R when there was moderate- quality evidence from one or more r and omized clinical trials , or meta-analyses of moderate- quality r and omized clinical trials . Level B-NR was used to denote moderate- quality evidence from one or more well- design ed , well-executed nonr and omized studies , observational studies , or registry studies . This design ation was also used to denote moderate- quality evidence from meta-analyses of such studies . Evidence was ranked as Level C-LD when the primary source of the recommendation was r and omized or nonr and omized observational or registry studies with limitations of design or execution , meta-analyses of such studies , or physiological or mechanistic studies of human subjects . Level C-EO was defined as expert opinion based on the clinical experience of the writing group . Despite a large number of authors , the participation of several societies and professional organizations , and the attempts of the group to reflect the current knowledge in the field adequately , this document is not intended as a guideline . Rather , the group would like to refer to the current guidelines on AF management for the purpose of guiding overall AF management strategies.5,6 This consensus document is specifically focused on catheter and surgical ablation of AF , and summarizes the opinion of the writing group members based on an extensive literature review as well as their own experience . It is directed to all health care professionals who are involved in the care of patients with AF , particularly those who are caring for patients who are undergoing , or are being considered for , catheter or surgical ablation procedures for AF , and those involved in research in the field of AF ablation . This statement is not intended to recommend or promote catheter or surgical ablation of AF . Rather , the ultimate judgment regarding care of a particular patient must be made by the health care provider and the patient in light of all the circumstances presented by that patient . The main objective of this document is to improve patient care by providing a foundation of knowledge for those involved with catheter ablation of AF . A second major objective is to provide recommendations for design ing clinical trials and reporting outcomes of clinical trials of AF ablation . It is recognized that this field continues to evolve rapidly . As this document was being prepared , further clinical trials of catheter and surgical ablation of AF were under way Background Delirium during intensive care unit ( ICU ) stay is frequent and associated with significant morbidity , mortality and healthcare-related costs . International guidelines suggest its prevention . However , curative treatment remains unclearly established . Despite contradictory and ambiguous academic literature , international guidelines suggest the use of second-generation ( atypical ) antipsychotics over haloperidol . However , haloperidol remains the most widely used neuroleptic worldwide as a first-line treatment of agitation and /or delirium . Dexmedetomidine , an alpha2-adrenergic receptors agonist , has shown its efficiency in the treatment of delirium in intubated patients but also in its prevention . Dexmedetomidine represents a widely used alternative to haloperidol . Only few studies have compared the efficacy of dexmedetomidine in non-intubated ICU patients as a first-line curative treatment of delirium . The main objective of the 4D trial is to demonstrate that dexmedetomidine  decreases delirium duration compared to placebo . Methods / design The 4D trial is an investigator-initiated , prospect i ve , multicenter , r and omized , double-blinded , two-arm trial , r and omizing 300 non-intubated ICU patients with a diagnosis of agitated delirium to receive  dexmedetomidine or placebo as a cure . In case of agitation ( RASS≥ + 2 ) , immediate haloperidol administration will be allowed , to protect patient and staff in charge , while waiting for study treatment action . The primary outcome measure is a composite of duration of agitation or delirium or the use of intubation with deep sedation and mechanical ventilation . Secondary outcomes include mortalities at 7 and 30 days , ICU length of stay and occurrence of adverse effects related to dexmedetomidine use ( bradycardia or hypotension requesting any treatment ; or haloperidol use ( neuroleptic malignant syndrome , extrapyramidal syndrome , prolonged QTc ) . The sample size will allow the detection of a 50 % decrease of agitation duration ( 120 min ) , of an absolute reduction of delirium duration ( 1 day ) and of a 50 % relative decrease of intubation and mechanical ventilation , with a type 1 error rate of 1.8 % ( error risk inflation due to components of composite ) and power of 90 % , assuming a 15 % incidence of intubation and mechanical ventilation requirements , an agitation duration of 240 min and a delirium duration of 3 days . One hundred and ten patients by group will be needed . An intermediate analysis is scheduled and requires the inclusion of 150 patients . Discussion The 4D trial may provide important data on the safety of commonly used sedative dexmedetomidine and could have a significant impact on future treatment of non-intubated ICU patients presenting with agitated delirium . Trial registration Clinical Trials.gov , ID : NCT 03317067 . Registered on 23 October 2017 AIMS The aim of this study was to identify predictors of completed suicide in a wide sample of psychiatric in patients receiving retrospective and prospect i ve DSM-IV diagnoses . METHODS We followed up 4441 severe psychiatric patients who were hospitalized for some time during a 35-year period in a private hospital setting . We collected sociodemographic , clinical and temperamental data . RESULTS Ninety-six patients from the sample committed suicide .  There were no sex differences in suicide completion and no differences between major psychiatric disorders , but people who had been hospitalized for anxiety disorders did not commit suicide and people with bipolar disorders were more likely to commit suicide than people with unipolar major depression . Shorter-term treatment with lithium and anticonvulsants , longer-term treatment with antidepressants , history of suicide attempts , suicidal thinking , and single status positively predicted completed suicide . Suicide tended to occur after a mean period of about 14 years of duration of disease . Patients ' symptoms during the period preceding suicide were assessed through interviewing patients ' physicians or family members . Symptoms occurring in > 10 % of cases were , in decreasing order , inner tension , racing/crowded thoughts , aggressive behavior , guilt , psychomotor agitation , persecutory ideation , anxiety , and hallucinations . Surprisingly , cyclothymic temperament was less associated with completed suicide as compared to other temperaments . CONCLUSIONS Suicide is likely to occur in a milieu of agitation , mixed anxiety and depression , and psychosis . Longer-term mood stabilizer treatment may reduce the rate of completed suicide Abstract The selective serotonin reuptake inhibitor citalopram was compared with clomipramine in a multicenter clinical study . From a total of 150 depressed patients ( age 18–65 years ) , 114 patients with a Hamilton Depression Scale ( HDS ) total score≧18 at the end of a 1 week placebo period were started on treatment with either citalopram ( 40 mg/day ) or clomipramine ( 150 mg/day ) ( fixed , single daily dose ) . Patients stratified according to diagnostic rating ( Newcastle Inventory , endogenous/non-endogenous ) were r and omly allocated to treatment groups using double blind principles . In total , 102 patients completed more than 2 weeks , treatment and were included in the analyses of therapeutic effect . The two drug groups were comparable in terms of sex , age , and departmental distribution . Categorical measurements of therapeutic effect based on the HDS total score showed that in the endogenously depressed patients a significantly higher percentage of patients on clomipramine ( n=37 ) than on citalopram ( n=38 ) were classified as complete responders ( HDS total≦7 ) after 3 , 4 and 5 weeks of treatment . In the non-endogenously depressed patients ( clomipramine : n=15 , citalopram : n=12 ) rather similar numerical differences were observed ( P<0.05 at 5th week ) . In the total patient group the percentage of complete response after 5 weeks was about 60 in the clomipramine group ( n=52 ) and about 30 in the citalopram group ( n=50 ) ( P<0.005 ) . The better effect of clomipramine seemed to be related in particular to the sleep items , but other items covering depression , retardation and anxiety/agitation also contributed to the difference in total score that was also seen in patients with low initial scores on the sleep items . Citalopram was devoid of the typical autonomic side effects and orthostatic hypotension seen with clomipramine . Symptoms of nausea/vomiting and headache became somewhat worse in the citalopram- and somewhat better in the clomipramine-treated patients . Participating centers:1Department of Psychiatry , Odense University Hospital , Odense , 2Department of Psychiatry , Rigshospitalet , University of Copenhagen , Copenhagen , 3Departments of Psychiatry , Frederiksborg General Hospital , Hillerød , 4Department A and C , Psychiatric University Hospital , Århus , 5Department of Psychiatry , Bornholm General Hospital , Rønne , 6Department of Clinical Pharmacology , Odense University , Odense Participating clinicians : J. And ersen2 , P. Bech2,3 , S. Benjaminsen1 , M. Bjerre1 , S. Bøjholm5 , P. Christensen1 , A. Gjerris2 , L. Hansted4 , E. Jensen3 , P. Kragh-Sørensen1 , C.B. Kristensen1,3 , P. Kyneb4 , D. Loldrup3 , O.F. Madsen4 , O.L. Pedersen1 , O.J. Rafaelsen2 , S. Rasmussen3 , N. Reisby4 , F. Sevaj3 , P. Simonsen4 , H.Y. Thomsen1 , P. Vestergaard4Coordination and drug assay : L.F. Gram6Statistical consultants : O. Aaskoven , P. Allerup Data - collection and -processing : C. Sánchez Steering Committee : P. Bech , L.F. Gram ( chairman ) , P. Kragh-Sørensen , O.J. Rafaelsen , N. Reisby , P. BACKGROUND Ongoing regimens of haloperidol , thioridazine , and lorazepam are commonly administered to manage behavior problems in nursing home residents . Nevertheless , there is controversy over whether periodic drug withdrawal should be attempted when those medications are prescribed . This study addressed that issue by examining the effects of discontinuing treatment with haloperidol , thioridazine , and lorazepam among residents of a large suburban nursing home . METHODS In a double-blind , crossover study , half of 58 nursing home residents ( 43 women and 15 men with a mean age of 86 years ) continued to take the psychotropic medication they had been prescribed , whereas the other half were tapered to placebo . After 6 weeks of taking placebo or original drug , patients were tapered to the reverse schedule and remained on it for 6 weeks . Assessment s included informant ratings by the nursing staff who completed the Brief Psychiatric Rating Scale and the Cohen-Mansfield Agitation Inventory . RESULTS Analyses comparing residents taking placebo to those taking medication after completion of the first phase showed no impact of drug therapy discontinuation on their behavior . Similarly , using the crossover design to compare residents ' behaviors while taking placebo vs. taking drugs , withdrawal of medication had no impact on Cohen-Mansfield Agitation Inventory or Brief Psychiatric Rating Scale scores . CONCLUSIONS Results of this work suggest that longterm use of haloperidol , thioridazine , and lorazepam in nursing homes to manage agitation should be closely monitored for their efficacy . Furthermore , routine attempts at drug withdrawal should be considered for most residents taking psychotropic medication Abstract Objective . Anxiety disorders are frequently under-diagnosed conditions in primary care , although they can be managed effectively by general practitioners . Methods . This paper is a short and practical summary of the World Federation of Biological Psychiatry ( WFSBP ) guidelines for the pharmacological treatment of anxiety disorders , obsessive – compulsive disorder ( OCD ) and posttraumatic stress disorder ( PTSD ) for the treatment in primary care . The recommendations were developed by a task force of 30 international experts in the field and are based on r and omized controlled studies . Results . First-line pharmacological treatments for these disorders are  selective serotonin reuptake inhibitors  ( for all disorders ) ,  serotonin-norepinephrine reuptake inhibitors  ( for some ) and  pregabalin  ( for generalized anxiety disorder only ) . A combination of  medication and cognitive behavior/exposure therapy  was shown to be a clinical ly desired treatment strategy . Conclusions . This short version of an evidence -based guideline may improve treatment of anxiety disorders , OCD , and PTSD in primary care “ Agitation ” is a term that is used to describe a wide range of dysfunctional behaviours in geriatric population s. The term is so widely used that in many cases it loses clinical meaning and therefore a more restricted use of the term is suggested . When patients with agitation are identified it is important to look for underlying treatable pathology which is often present . Controversy surrounding the most appropriate medications is review ed with particular reference to both neuroleptics and benzodiazepines . A r and omized double-blind comparison of lorazepam and alprazolam in demented patients with agitation was earned out . While both drugs were efficacious for some patients , there were significantly more serious side-effects with lorazepam . It appears that there is a role for benzodiazepines such as alprazolam in the management of the agitated demented patient i ( n d m e This is one of a series of statements discussing the use of GI endoscopy in common clinical situations . The St and ards of Practice Committee of the American Society for Gastrointestinal Endoscopy prepared this text . In preparing this guideline , a search of the medical literature was performed using PubMed . Additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants . When limited or no data exist from well- design ed prospect i ve trials , emphasis is given to results of large series and reports from recognized experts . Guidelines for appropriate use of endoscopy are based on a critical review of the available data and expert consensus at the time the guidelines are drafted . Further controlled clinical studies may be needed to clarify aspects of this guideline . This guideline may be revised as necessary to account for changes in technology , new data , or other aspects of clinical practice . The recommendations were based on review ed studies and were grade d on the strength of the supporting evidence ( Table 1).1 The strength of individual recommendations is based on both the aggregate evidence quality and an assessment of the anticipated benefits and harms . Weaker recommendations are indicated by phrases such as “ we suggest , ” whereas stronger recommendations are typically stated as “ we recommend . ” This guideline is intended to be an educational device to provide information that may assist endoscopists in providing care to patients . This guideline is not a rule and should not be construed as establishing a legal st and ard of care or as encouraging , advocating , requiring , or discouraging any particular treatment . Clinical decisions in any particular case involve a complex analysis of the patient ’s condition and available courses of action . Therefore , clinical considerations may lead an endoscopist to take a course of action that varies from these guidelines Objective To determine whether a systematic approach to the treatment of pain can reduce agitation in people with moderate to severe dementia living in nursing homes . Design Cluster r and omised controlled trial . Setting 60 clusters ( single independent nursing home units ) in 18 nursing homes within five municipalities of western Norway . Participants 352 residents with moderate to severe dementia and clinical ly significant behavioural disturbances r and omised to a stepwise protocol for the treatment of pain for eight weeks with additional follow-up four weeks after the end of treatment ( 33 clusters ; n=175 ) or to usual treatment ( control , 27 clusters ; n=177 ) . Intervention Participants in the intervention group received individual daily treatment of pain for eight weeks according to the stepwise protocol , with paracetamol ( acetaminophen ) , morphine , buprenorphine transdermal patch , or pregabaline . The control group received usual treatment and care . Main outcome measures Primary outcome measure was agitation ( scores on Cohen-Mansfield agitation inventory ) . Secondary outcome measures were aggression ( scores on neuropsychiatric inventory-nursing home version ) , pain ( scores on mobilisation-observation-behaviour-intensity-dementia-2 ) , activities of daily living , and cognition ( mini-mental state examination ) . Results Agitation was significantly reduced in the intervention group compared with control group after eight weeks ( repeated measures analysis of covariance adjusting for baseline score , P<0.001 ) : the average reduction in scores for agitation was 17 % ( treatment effect estimate −7.0 , 95 % confidence interval −3.7 to −10.3 ) . Treatment of pain was also significantly beneficial for the overall severity of neuropsychiatric symptoms ( −9.0 , −5.5 to −12.6 ) and pain ( −1.3 , −0.8 to −1.7 ) , but the groups did not differ significantly for activities of daily living or cognition . Conclusion A systematic approach to the management of pain significantly reduced agitation in residents of nursing homes with moderate to severe dementia . Effective management of pain can play an important part in the treatment of agitation and could reduce the number of unnecessary prescriptions for psychotropic drugs in this population . Trial registration Clinical Trials.gov NCT01021696 and Norwegian Medicines Agency EudraCTnr 2008 - 007490 - 20 Purpose Cardiac dysfunction is a serious adverse effect of certain cancer-directed therapies that can interfere with the efficacy of treatment , decrease quality of life , or impact the actual survival of the patient with cancer . The purpose of this effort was to develop recommendations for prevention and monitoring of cardiac dysfunction in survivors of adult-onset cancers . Methods Recommendations were developed by an expert panel with multidisciplinary representation using a systematic review ( 1996 to 2016 ) of meta-analyses , r and omized clinical trials , observational studies , and clinical experience . Study quality was assessed using established methods , per study design . The guideline recommendations were crafted in part using the Guidelines Into Decision Support methodology . Results A total of 104 studies met eligibility criteria and compose the evidentiary basis for the recommendations . The strength of the recommendations in these guidelines is based on the quality , amount , and consistency of the evidence and the balance between benefits and harms . Recommendations It is important for health care providers to initiate the discussion regarding the potential for cardiac dysfunction in individuals in whom the risk is sufficiently high before beginning therapy . Certain higher risk population s of survivors of cancer may benefit from prevention and screening strategies implemented during cancer-directed therapies . Clinical suspicion for cardiac disease should be high and threshold for cardiac evaluation should be low in any survivor who has received potentially cardiotoxic therapy . For certain higher risk survivors of cancer , routine surveillance with cardiac imaging may be warranted after completion of cancer-directed therapy , so that appropriate interventions can be initiated to halt or even reverse the progression of cardiac dysfunction Diabetes is the leading cause of major complications , such as end-stage renal disease and lower extremity amputations , and is a significant contributor to ischemic heart disease , stroke , peripheral vascular disease , and vision loss ( 1 ) . There has been increasing acceptance of the importance of individualizing glycemic management and assessment of risk for adverse events , especially hypoglycemia ( 26 ) . This is of great importance for all patients , especially older adults ( aged 65 years ) with comorbid conditions . In 2013 , 12.0 million older adults in the United States had diabetes , comprising 40 % of the 30.2 million persons with the disease ( 7 ) . Older adults account for an estimated 60 % to 70 % of the U.S. Department of Veterans Affairs ( VA ) and U.S. Department of Defense ( DoD ) diabetic population ( largely retirees ) ( VA/DoD. Unpublished data ) . These considerations make safe and effective diabetes management a policy priority for health care providers ( physicians , nurses , dietitians , and pharmacists ) and policymakers in both the VA and the DoD. The 2017 VA/DoD Clinical Practice Guideline ( CPG ) for the Management of Type 2 Diabetes Mellitus in Primary Care offers health care providers an evidence -based framework to evaluate , treat , and manage persons with type 2 diabetes  mellitus in the context of their individual needs and preferences ( 8) . The current article is a summary of key CPG recommendations , which was developed with multiple stakeholders to ensure representation by a broad spectrum of clinicians . It provides practice recommendations for the care of patients with diabetes , with an emphasis on shared decision making . Guideline Development and Review Process These recommendations were developed using methods established by the VA/DoD Evidence -Based Practice Work Group ( EBPWG ) ( 9 ) , which are aligned with st and ards for trustworthy guidelines ( 10 ) . The EBPWG and the U.S. Army Medical Comm and selected guideline panel cochairs ( 1 each from the VA and the DoD ) . The cochairs then selected a multidisciplinary panel of practicing clinician stakeholders , including primary care physicians ( family and internal medicine ) , endocrinologists , medical nutritionists , pharmacists , diabetes educators , and nurse practitioners . At the start of the CPG development process and at other key points throughout , all members were required to su bmi t disclosure statements for potential conflicts of interest in the previous 24 months . Verbal affirmations of no conflicts were used during meetings throughout the development process . The project team was also subject to r and om Web-based surveillance ( for example , ProPublica ) . The VA/DoD contracted with The Lewin Group , a third party with expertise in clinical practice guideline development , to facilitate meetings . The guideline panel , in collaboration with the ECRI Institute , developed 9 key questions using the PICOTS ( population , intervention , comparator , outcomes , timing of outcomes measurement , and setting ) format . A systematic search of the peer- review ed literature from January 2009 through March 2016 was conducted to find evidence relevant to the key questions that focused on r and omized trials , systematic review s , and meta-analyses of fair or better quality . One key question was up date d through 14 June 2016 . The search methods and results are detailed in the full guideline ( 8) . The guideline panel rated recommendations by using the GRADE ( Grading of Recommendations Assessment , Development and Evaluation ) method ( 11 ) . The guideline panel focused on developing new and up date d recommendations using the evidence review for the key questions . The panel also considered , without a complete review of the relevant evidence , the current applicability of recommendations that were included in the 2010 CPG . As part of the development process , a patient focus group was also convened to better underst and the perspectives of patients receiving diabetes treatment in the VA and the DoD. Five patients were included , consistent with the requirements of the federal Paperwork Reduction Act . All patients had type 2 diabetes and were veterans receiving care in the VA . The focus group explored knowledge of treatment options , views on the delivery of care , patients ' needs and preferences , and the effect of diabetes on their lives . Important concepts that emerged from the focus group were shared with the panel and informed guideline development . It was acknowledged that this convenience sample may not be representative of all VA and DoD patients receiving treatment for type 2 diabetes . The draft guideline was sent to more than 15 expert review ers inside and outside the federal sector . Comments were review ed and , where appropriate , were incorporated into the final guideline based on panel consensus . The VA/DoD EBPWG approved the final document on 3 April 2017 and released it on 17 April 2017 . Recommendations are presented in the Table , and an algorithm for establishing a personalized glycemic goal and treatment plan is presented in the Figure . Key recommendations are review ed in this article . Table . Summary of Recommendations From the 2017 VA/DoD CPG on the Management of Type 2 Diabetes Mellitus Figure . Algorithmic approach to evaluating glycemic control risk factors , setting a personalized glycemic control target range , providing self-management ( including lifestyle and nutrition ) education , and initiating or reevaluating medication therapy . Recommendations Provide Patient-Centered Care and Incorporate Shared Decision Making The CPG strongly encourages clinicians to incorporate shared decision making and partner with their patients . Shared decision making is the process by which the patient and family , in conjunction with the care provider , reach an agreement about a plan of care and treatment . Key principles include readiness of the patient and family , tools with underst and able information about the benefits and harms of all options , and strategies to identify and incorporate patient preferences . Patients can not effectively participate in care and shared decision making unless they underst and diabetes and how they can be involved in planning and carrying out the jointly developed care plan . Shared decision making reinforces a trusted therapeutic relationship and increases patient satisfaction and treatment buy-in with regard to the methods used to reach a particular goal or treatment plan ( 1214 ) . It should be used not only for patients with stable glycemic control but also to assist those who are not able or willing to make lifestyle changes and decisions that affect their diabetes at any time during the course of treatment . At a minimum , shared decision making should be included at the time of diagnosis , during difficulties with management , and at times of transition or development of complications ( 14 ) . Benefits include greater knowledge of medications ( 13 ) and underst and ing of risks ( 14 ) . In addition , patient-centered care and shared decision making together may decrease patient anxiety , increase trust in clinicians ( 15 ) , and improve treatment adherence ( 16 ) . Family involvement should be considered if appropriate , especially in older adults ( 17 ) . Patient information should be culturally appropriate ; underst and able and actionable by people with limited literacy skills ; and accessible to those with physical , sensory , or learning needs ( 18 ) . As part of the patient-centered care approach to diabetes management , clinicians should explore with the patient the outcomes of previous opportunities for shared decision making , their ability to self-manage , prior efforts to change health behaviors , past treatment experiences ( including reasons for discontinuing treatment ) , and relevant clinical outcomes . In actively sharing decisions , they should involve the patient in prioritizing problems to be addressed and setting specific goals regardless of the setting or level of care . Assess Patient Characteristics and Nonglycemic Factors When Interpreting Results of Hemoglobin A1c , Fructosamine , and Other Glycemic Biomarker Testing Many factors affect measurement of hemoglobin A1c ( HbA1c ) besides the level of glycemia ( 19 ) . Because HbA1c level depends on the duration of erythrocyte exposure to glucose , conditions that alter erythrocyte life span affect the measured level of HbA1c ( 20 , 21 ) . Iron deficiency anemia , which prolongs erythrocyte life span and exposes the cell to glucose for a longer period , is associated with falsely elevated HbA1c levels ( 22 ) . In contrast , conditions that shorten erythrocyte life span ( such as hemolytic anemia ) may result in falsely low HbA1c levels . Various other conditions , such as chronic kidney disease , may alter HbA1c measurement . Hemoglobin variants can result in falsely elevated or falsely lowered HbA1c levels , depending on the assay used ( 2325 ) . In addition , oral hypoglycemic agents ( metformin or sulfonylureas ) may alter the relationship between blood glucose and HbA1c levels , although the clinical significance is unclear ( 26 ) . There are also racial/ethnic differences in HbA1c levels for a given level of glycemia . A previous study found that African Americans with prediabetes ( 27 ) had HbA1c values that were 0.4 % higher than among white persons ; those who were within 3 years of diagnosis ( 28 ) also had higher HbA1c values than white persons for any measure of glycemia . This difference can not be explained by measured differences in glycemia , clinical factors known to affect HbA1c measurement , or sociodemographic factors ( 27 , 28 ) . Therefore , it is recommended that a new diagnosis of diabetes be based on a confirmatory fasting blood glucose level of at least 7.0 mmol/L ( 126 mg/dL ) if the initial HbA1c value is 6.5 % to 6.9 % . How and where the HbA1c level is measured can also affect results because of intralaboratory variation ( variation in test accuracy and precision ) and interlaboratory variation ( variation related to use of different test methods ) . A single HbA1c measurement , even from a The publication of major studies dealing with the natural history of bradyarrhythmias and tachyarrhythmias and major advances in the technology of pacemakers and implantable cardioverter-defibrillators ( ICDs ) has m and ated this revision of the 1991 ACC/AHA Guidelines for Implantation of Pacemakers and Antiarrhythmia Devices . This executive summary appears in the April 7 , 1998 issue of Circulation . The full text of the guidelines , including the ACC/AHA Class I , II , and III recommendations , is published in the April 1998 issue of the Journal of the American College of Cardiology . Reprints of both the executive summary and the full text are available from both organizations . Following extensive review of the medical literature and related documents previously published by the American College of Cardiology , the American Heart Association , and the North American Society for Pacing and Electrophysiology , the writing committee developed recommendations that are evidence based whenever possible . Evidence supporting current recommendations is ranked as level A if the data were derived from multiple r and omized clinical trials involving a large number of individuals . Evidence was ranked as level B when data were derived from a limited number of trials involving comparatively small numbers of patients or from well- design ed data analysis of nonr and omized studies or observational data registries . Evidence was ranked as level C when consensus of expert opinion was the primary source of recommendation . The committee emphasizes that for certain conditions for which no other therapies are available , the indications for device therapies are based on years of clinical experience as well as expert consensus and are thus well supported , even though the evidence was ranked as level C. These guidelines include exp and ed sections on selection of pacemakers and ICDs , optimization of technology , cost , and follow-up of implanted devices . The follow-up sections are relatively brief because in many instances the type and frequency of follow-up examinations This is one of a series of statements discussing the use of GI endoscopy in common clinical situations . The St and ards of Practice Committee of the American Society for Gastrointestinal Endoscopy ( ASGE ) prepared this text . In preparing this guideline , a search of the medical literature was performed by using PubMed . Additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants . When few or no data exist from well- design ed prospect i ve trials , emphasis is placed on results from large series and reports from recognized experts . Guidelines for appropriate use of endoscopy are based on a critical review of the available data and expert consensus at the time the guidelines are drafted . Further controlled clinical studies may be needed to clarify aspects of this guideline . This guideline may be revised as necessary to account for changes in technology , new data , or other aspects of clinical practice . The recommendations are based on review ed studies and are grade d on the quality of the supporting evidence ( Table 1 ) . The strength of individual recommendations is based on both the aggregate evidence quality and an assessment of the anticipated benefits and harms . Weaker recommendations are indicated by phrases such as ‘ ‘ we suggest , ’ ’ whereas stronger recommendations are typically stated as ‘ ‘ we recommend . ’ ’ This guideline is intended to be an educational device to provide information that may assist endoscopists in providing care to patients . This guideline is not a rule and should not be construed as establishing a legal st and ard of care or as encouraging , advocating , requiring , or discouraging any particular treatment . Clinical decisions in any particular case involve a complex analysis of the patient ’s condition and available courses of action . Therefore , clinical considerations may lead an endoscopist to take a course of action that varies from this guideline . Upper GI endoscopy has largely replaced upper GI barium x-ray series for the evaluation of upper GI tract disease or symptoms because it allows direct visualization , tissue acquisition , and therapeutic interventions . This guideline is an up date of a previous ASGE document and defines the role of upper GI endoscopy in the Objective : This paper describes the characteristics of 303 consecutive referrals , over a 12-month period , to a consultation — liaison ( C — L ) psychiatry service provided to eight group general practice s in Newcastle , Australia . Method : A purpose design ed service audit form was used throughout the evaluation period to collect information about demographic characteristics , reasons for referral , service contacts , psychiatric diagnoses and clinical management . In addition , patients were invited to participate in a separate , prospect i ve outcome evaluation study , which involved structured interviews and question naires . Results : The most common reasons for referral were : depression ( 33 % ) ; anxiety ( 12 % ) ; diagnostic assessment ( 9 % ) ; and impaired relationships ( 8 % ) . The most common psychiatric diagnoses were : mood disorders ( 29 % ) ; mild , transient conditions ( 29 % ) ; anxiety ( 14 % ) ; and substance abuse disorders ( 12 % ) . Following the psychiatric consultation(s ) , GPs were actively involved in patients ’ treatment in 53 % of cases . However , there was a higher than expected rate of referral ( 44 % ) to another mental health agency . Selected comparisons are also reported between patients referred to the C — L service ( n = 303 ) and a sample of non-referred GP attenders ( n = 535 ) . Conclusions : As expected , the diagnostic profiles of patients attending the C — L service  differed in several respects from those using similar services in general hospitals . There were comparatively low rates of organic brain syndromes , suicide risk evaluations , and problems of differential diagnosis of somatic symptoms . Greater emphasis needs to be placed on more formal psychiatric education for GPs , on ways of screening out from the referral process those patients with mild , transient conditions who do not require specialist expertise , and on the development of strategies to help GPs manage such conditions The British Association for Psychopharmacology guidelines specify the scope and targets of treatment for bipolar disorder . The third version is based explicitly on the available evidence and presented , like previous Clinical Practice Guidelines , as recommendations to aid clinical decision making for practitioners : it may also serve as a source of information for patients and carers , and assist audit . The recommendations are presented together with a more detailed review of the corresponding evidence . A consensus meeting , involving experts in bipolar disorder and its treatment , review ed key areas and considered the strength of evidence and clinical implication s. The guidelines were drawn up after extensive feedback from these participants . The best evidence from r and omized controlled trials and , where available , observational studies employing quasi-experimental design s was used to evaluate treatment options . The strength of recommendations has been described using the GRADE approach . The guidelines cover the diagnosis of bipolar disorder , clinical management , and strategies for the use of medicines in short-term treatment of episodes , relapse prevention and stopping treatment . The use of medication is integrated with a coherent approach to psychoeducation and behaviour change Coronary artery bypass grafting (CABG)-related bleeding complications and perioperative coronary events are strongly influenced by the management of antithrombotic therapy before and after CABG . Bleeding but also blood products transfusion increase the risk of death and compromise the long-term benefits of CABG.1 The use of new P2Y12 inhibitors , increasing pre-CABG percutaneous coronary interventions ( PCI ) with drug eluting stents ( DES ) requiring specific antiplatelet regimens , and advances in surgical technique has prompted the ESC Working Group on Cardiovascular Surgery and the ESC Working Group on Thrombosis to review the evidence of peri-CABG recommendations on antithrombotic management . Due to the paucity of r and omized trials , most of the evidence is still derived from observational studies and expert consensus , further reinforcing the importance of a multidisciplinary consultation for optimal decision making . # # # Benefits of preoperative aspirin Aspirin ( acetylsalicylic acid , ASA ) is recommended as secondary prevention therapy for all patients with proven coronary artery disease ( CAD ) and without contraindications . Its indication is even stronger for post-CABG patients ( recommendation IA).2 The general consensus is that ASA treatment withdrawal has ominous prognostic implication s in patients with CAD , especially in those with intracoronary stents , and should be advocated only when the bleeding risk clearly outweighs that of atherothrombotic events.3 The benefits of continuing ASA until the day of CABG ( ‘ preoperative ASA ’ ) are less clear and may explain the wide variability in the management of ASA therapy in the perioperative period and differences between guidelines endorsed by different professional and scientific societies ( Supplementary material online , Table S1 ) . This was based on the demonstration that ASA started the day before surgery was no more effective than ASA started 6 h after surgery at improving early ( 7- to 10-day ) graft patency , but was associated with increased bleeding complications.4 More recent evidence suggests , however , that ASA use within 5–7 days prior to CABG Dual antiplatelet therapy with aspirin and a P2Y12 receptor blocker is a key strategy to reduce platelet reactivity and to prevent thrombotic events in patients treated with percutaneous coronary intervention . In an earlier consensus document , we proposed cutoff values for high on-treatment platelet reactivity to adenosine diphosphate ( ADP ) associated with post-percutaneous coronary intervention ischemic events for various platelet function tests ( PFTs ) . Up date d American and European practice guidelines have issued a Class IIb recommendation for PFT to facilitate the choice of P2Y12 receptor inhibitor in selected high-risk patients treated with percutaneous coronary intervention , although routine testing is not recommended ( Class III ) . Accumulated data from large studies underscore the importance of high on-treatment platelet reactivity to ADP as a prognostic risk factor . Recent prospect i ve r and omized trials of PFT did not demonstrate clinical benefit , thus question ing whether treatment modification based on the results of current PFT platforms can actually influence outcomes . However , there are major limitations associated with these r and omized trials . In addition , recent data suggest that low on-treatment platelet reactivity to ADP is associated with a higher risk of bleeding . Therefore , a therapeutic window concept has been proposed for P2Y12 inhibitor therapy . In this up date d consensus document , we review the available evidence addressing the relation of platelet reactivity to thrombotic and bleeding events . In addition , we propose cutoff values for high and low on-treatment platelet reactivity to ADP that might be used in future investigations of personalized antiplatelet therapy Discharge from psychiatric inpatient care is frequently described as chaotic , stressful , and emotionally charged . Following discharge , service users are vulnerable to becoming overwhelmed by the challenges involved in readapting to their home environments , which could result in serious problems and lead to readmission . The short transitional intervention in psychiatry ( STeP ) is a bridging intervention that includes pre- and post-discharge sections . It aims to prepare patients for specific situations in the period immediately following discharge from a psychiatric hospital . We conducted a quasi-experimental pilot study to determine the feasibility of the intervention , and gain insight into the effects of the STeP. Two inpatient wards at a Swiss psychiatric hospital participated in the study , and represented the intervention and control arms . Patient recruitment and baseline assessment were performed 2 weeks prior to discharge . Follow-up data were collected 1 week subsequent to discharge . Question naires measured coping , admission and health-care usage , self-efficacy , working alliance , experience of transition , and the number of difficulties experienced following discharge .  Fourteen and 15 patients completed the follow-up assessment in the control and intervention groups , respectively . The STeP did not affect primary or secondary outcomes ; however , it was shown to be feasible , and patients ' feedback highlighted the importance of post-discharge contact sessions . Further research is required to improve underst and ing of the discharge experience , identify relevant patient outcomes , and assess the effectiveness of the intervention in an adequately-powered r and omized , controlled trial The objective of this study was to evaluate the clinical utility of a decisional aid for mental capacity assessment  s which was developed using a group judgment methodology . This was carried out by a r and omized , controlled trial . The subjects comprised 64 University of Toronto psychiatry residents in postgraduate years 1 through 4 . Residents were r and omized to carry out mental capacity assessment s on simulated cases with , or without , the use of the decisional aid . The main outcome measure was the extent of agreement between the mental capacity determinations of residents and those of experts . There was no difference between the intervention and control groups with respect to the overall mean level of agreement with experts ( 0.87 vs 0.86 , p = 0.88 ; 95 % confidence interval for the difference between the study groups , -0.07 to + 0.08 ) . A logistic regression analysis , which adjusted for imbalances between the groups , also revealed no difference between the groups in their agreement with experts . The mean time per competency assessment was significantly longer in the intervention group ( 19.1 vs 10.8 min ; p < 0.001 ) . It was concluded that the decisional aid did not improve the ability of the psychiatry residents to make mental capacity assessment s on simulated cases . Despite relatively limited formal training , the psychiatry residents had a high level of agreement with experts BACKGROUND The administration p.r.n . ( as needed ) of sedative medications is a widespread practice in the management of acute dyscontrol of child psychiatric in patients . Its efficacy , however , has never been tested in a controlled clinical trial . METHOD Twenty-one male in patients , aged 5 - 13 years , participated in a double-blind , placebo-controlled study of the p.r.n . use of diphenhydramine , a sedative antihistaminic often used in child psychiatry wards . The patients ' DSM-III-R diagnoses were conduct disorder , attention-deficit hyperactivity , and major depression . Each patient in acute dyscontrol blindly received either oral or intramuscular doses of diphenhydramine 25 - 50 mg ( N = 9 ) or placebo ( N = 12 ) . The Conners Abbreviated 10-Item Teacher Rating Scale and the Clinical Global Impressions scale were completed before and 0.5 , 1 , and 2 hours after the dose . RESULTS Repeated measures ANOVA showed significant time effects , but no difference due to drug . The intramuscular route tended to be more effective than the oral , regardless of whether active drug or placebo was given . CONCLUSION The data indicate that if p.r.n . administrations are effective , this is a placebo effect . Likewise , intramuscular administrations are more effective because of a route effect ( " the needle " ) and not because of a specific pharmacologic activity Patients hope that their doctors will correctly identify health problems , clearly articulate sensible options for managing each problem , wisely interpret the best available evidence about probable outcomes associated with each option , sensitively solicit patient preferences for each outcome , and thereby implement practice s that are likely to achieve the results patients care about . Groups of patients hope that doctors will work to prevent , detect , and treat health problems in a way that maximizes the public good achieved with available health care re sources . To meet these dual expectations , doctors face forbidding tasks of clinical decision making . Improved methods for preparing , appraising , and abstract ing overviews of available evidence about a clinical topic can bring a broader range of high- quality information within the busy practitioner 's grasp [ 1 - 4 ] . However , even well- design ed overviews often do not synthesize information about benefits , harms , and costs of medical practice s in a way that facilitates clinical decision making . Clinical practice guidelines have been defined as systematic ally developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances [ 5 ] . Guidelines that are based on sound scientific evidence , and a trustworthy process for judging the value of alternative practice s , could help physicians deal with the information overload they face . Existing practice guidelines , however , vary widely in their quality , and clinicians should carefully consider the validity and applicability of each guideline they read . We propose a structured format for abstract s of articles describing practice guidelines that is based on emerging principles of guideline development and evaluation [ 6 - 13 ] . The proposal is design ed to help readers obtain the key information needed to assess the applicability , importance , and validity of any guideline . The proposed structure for more informative abstract s of articles describing clinical practice guidelines has been review ed and pilot-tested by guideline developers , evaluators , and implementors and by groups of practicing clinicians . Early versions of the proposal were sent to consultants at the National Library of Medicine , the Institute of Medicine , the American College of Physicians ( ACP ) , and the Agency for Health Care Policy and Research . Subsequent versions of the proposal were pilot tested on various published guidelines and were assessed by selected health care organizations for applicability to guidelines under development . An improved proposal was sent to 82 persons active in guideline development , evaluation , and implementation . The Internal Medicine Center to Advance Research and Education circulated the proposal to volunteer practitioners , and the authors solicited feedback from physician and health administrator participants at three national workshops about practice guidelines . The proposal that follows represents an integration of the collective wisdom of our external review ers . ( A glossary of terms used in articles on clinical practice guidelines is supplied in the Appendix . ) Proposed Structure and Content for Abstract s of Articles Describing Clinical Practice Guidelines The proposed structure for abstract s of papers describing clinical practice guidelines is summarized in Table 1 . Key elements of the guideline development process are captured with statements about the principal objective and target of the guideline , the main practice options and outcomes that were considered , the nature of the evidence and values that were analyzed , the main benefits and harms expected from guideline implementation , the key recommendations , and a statement of whether the recommendations have been tested and by whom they have been endorsed . If details about guideline development methods or supporting evidence are published separately , then the abstract should indicate the existence of supporting documents and the most relevant parts of those should be summarized in the abstract . To be included in their entirety in the online bibliographic data bases of the National Library of Medicine , structured abstract s of clinical practice guidelines should not exceed 4096 characters ( approximately 500 words ) in length . Individual journals may have different requirements . Table 1 . Proposed Format for Structured Abstract s of Clinical Practice Guidelines Objective The abstract should state the objective of the guideline by identifying the targeted health problem , the targeted patients and physicians , and the main reason or reasons for developing new recommendations concerning this problem for this population . For guidelines primarily concerned with the management of health conditions , the stage of illness and intent to prevent , diagnose , treat , or palliate the disorder should be specified . For guidelines primarily concerned with health procedures , an intervention and its role in patient management should be defined . Targeted providers , setting s , and patients should be specified so that readers can tell who should do what , where it should be done , and to whom . A statement of objective also may specify why a new guideline is needed and how it should be used . Practice guidelines may be written to clarify or resolve clinical controversies , to communicate important new findings from clinical studies , or to promote more effective , efficient , or consistent physician practice s at less cost or risk to patients . Guidelines may be used concurrently to help physicians and patients make choices ( for example , clinical algorithms ) , retrospectively to compare physician choices to pre-established criteria ( for example , utilization review ) , or prospect ively to set limits on physician choices ( for example , preprocedure approval ) . Options Clinical practice guidelines pertain to clinical decisions . The nature of those decisions should be made explicit by disclosing the main management options considered . The abstract should list principal alternative preventive , diagnostic , or therapeutic strategies available to targeted clinicians and patients . Outcomes The abstract also should specify which health outcomes , such as death , morbidity , quality of life , economic costs , or changes in the process of health care were considered . Evidence To estimate the probable effect of a health intervention on an outcome , relevant data must be defined , gathered , and appraised . Readers need to know what kind of evidence was considered and what methods were used to select and combine evidence from different sources . Potential sources of evidence about clinical outcomes include the results of clinical studies ( published or unpublished ) , expert opinion , information contained in public or private health data bases , and direct input from patients or providers . Potential sources of evidence about economic outcomes include the results of cost-effectiveness studies , various fee schedules , and information contained in public or private health cl aims data bases . Potential methods of gathering evidence include computerized search es for articles that satisfy predetermined criteria , review s of bibliographies of relevant articles , and surveys of relevant persons or organizations [ 1 ] . The abstract should state whether explicit methods were used to combine results from scientific studies ( for example , meta- analysis ) or opinions of experts ( for example , Delphi technique ) [ 14 , 15 ] . The abstract may also indicate whether specific criteria were used to gauge the quality of information from different sources [ 16 , 17 ] . Scientific evidence regarding the likelihood of certain outcomes is often missing or conflicting . It is desirable for the strength of evidence supporting a guideline to be gauged in some way [ 16 ] . If gaps in the evidence were bridged formally ( for example , through use of decision- analysis models ) or informally ( for example , best guess of clinical experts ) , then major assumptions or areas of uncertainty should be acknowledged [ 11 ] . Because of the extraordinary time required to properly assemble and review evidence and then to achieve consensus about practice recommendations , the abstract of a practice guideline should specify the publication date s of the most recent evidence considered . If a sensitivity analysis was performed , then any major vulnerability of the guideline to weaknesses in the evidence should be acknowledged . These considerations may be summarized by qualifying a guideline as provisional by specifying date s for expiration or review , by listing studies in progress that could affect the guideline , or by identifying key research priorities . Values The declaration of a recommended practice presumes an implicit or explicit process for judging the relative desirability of the health , economic , and process outcomes associated with alternative practice s. These are matters of opinion and value . For example , in developing guidelines for breast cancer screening , it is necessary to weigh the value of preventing a death from breast cancer against the value of avoiding unnecessary harm or anxiety in women who do not have breast cancer . A high value placed on maximizing detection of asymptomatic malignancy may motivate an organization to recommend teaching self-examination of breasts to young women [ 18 ] . A relatively greater value placed on avoiding false-positive results may motivate others to not promote such programs [ 19 ] . Consequently , the principal sources of such values and the method by which judgments were made should be reported in guideline abstract s. At a minimum , the abstract should identify the major groups that participated in the process of assigning values to outcomes ( for example , generalist or specialist physicians , other health care providers , insurers , representatives of health organizations , and special-interest groups ) and whether patient preferences were represented . The abstract may also indicate the method used to synthesize opinions from Distinct calming rather than nonspecific sedation is desirable for the treatment of acute agitation . In 3 double-blind studies , acutely agitated patients with schizophrenia ( N = 311 ) , bipolar mania ( N = 201 ) , or dementia ( N = 206 ) were treated with intramuscular ( 1 - 3 injections/24 hrs ) olanzapine ( 2.5 - 10.0 mg ) , haloperidol ( 7.5 mg ) , lorazepam ( 2.0 mg ) , or placebo . The Agitation-Calmness Evaluation Scale ( ACES ; Eli Lilly and Co. ) and treatment-emergent adverse events assessed sedation . Across all studies , 1 patient ( lorazepam-treated , bipolar ) became unarousable . There were no significant between-group differences in ACES scores of deep sleep or unarousable at any time across . Excluding asleep patients , agitation remained significantly more reduced with olanzapine than placebo ( P < .05 ) . The incidences of adverse events indicative of sedation were not significantly different with olanzapine versus comparators . For the treatment of acute agitation associated with schizophrenia , bipolar mania , or dementia , intramuscular olanzapine-treated patients experienced no more sedation than haloperidol- or lorazepam-treated patients and experienced distinct calming rather than nonspecific sedation In 2016 , the American College of Cardiology published the first expert consensus decision pathway ( ECDP ) on the role of non-statin therapies for low-density lipoprotein (LDL)-cholesterol lowering in the management of atherosclerotic cardiovascular disease ( ASCVD ) risk . Since the publication of that document , additional evidence and perspectives have emerged from r and omized clinical trials and other sources , particularly considering the longer-term efficacy and safety of proprotein convertase subtilisin/kexin 9 ( PCSK9 ) inhibitors in secondary prevention of ASCVD . Most notably , the FOURIER ( Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk ) trial and SPIRE-1 and -2 ( Studies of PCSK9 Inhibition and the Reduction of Vascular Events ) , assessing evolocumab and bococizumab , respectively , have published final results of cardiovascular outcomes trials in patients with clinical ASCVD and in a smaller number of high-risk primary prevention patients . In addition , further evidence on the types of patients most likely to benefit from the use of ezetimibe in addition to statin therapy after acute coronary syndrome has been published . Based on results from these important analyses , the ECDP writing committee judged that it would be desirable to provide a focused up date to help guide clinicians more clearly on decision making regarding the use of ezetimibe and PCSK9 inhibitors in patients with clinical ASCVD with or without comorbidities . In the following summary table , changes from the 2016 ECDP to the 2017 ECDP Focused Up date are highlighted , and a brief rationale is provided . The content of the full document has been changed accordingly , with more extensive and detailed guidance regarding decision making provided both in the text and in the up date d algorithms . Revised recommendations are provided for patients with clinical ASCVD with or without comorbidities  on statin therapy for secondary prevention . The ECDP writing committee judged that these new data did not warrant changes to the decision pathways and algorithms regarding the use of ezetimibe or PCSK9 inhibitors in primary prevention patients with LDL-C < 190 mg/dL with or without diabetes mellitus or patients without ASCVD and LDL-C ≥190 mg/dL not due to secondary causes . Based on feedback and further deliberation , the ECDP writing committee down- grade d recommendations regarding bile acid sequestrant use , recommending bile acid sequestrants only as optional secondary agents for consideration in patients intolerant to ezetimibe . For clarification , the writing committee has also included new information on diagnostic categories of heterozygous and homozygous familial hypercholesterolemia , based on clinical criteria with and without genetic testing . Other changes to the original document were kept to a minimum to provide consistent guidance to clinicians , unless there was a compelling reason or new evidence , in which case justification is provided INTRODUCTION Retrospective research has become largely undervalued and underutilized in child and adolescent psychiatry with the increasing singular focus on r and omized control trials , despite the wealth of clinical ly relevant data available in historical medical records . In this paper a systematic and scientific approach to chart review research methodology for psychiatry is described . METHOD Informed by available literature , a method ological stepwise approach for retrospective chart review was developed . RESULTS A nine step method aim ed at maximizing benefits and minimizing limitations is discussed . CONCLUSIONS Retrospective chart review is an important methodology with distinct advantages and has the potential to provide psychiatry with valuable research opportunities . This method of study should not be lost in the field of psychiatry The combination of haloperidol , 5 mg , and lorazepam , 4 mg , was both effective and safe for managing agitated behavior in an open trial with acutely psychotic patients . The combination also appeared to be superior to its individual components when studied in a r and omized , nonblind trial . The principle of the combined use of antipsychotics and sedative-hypnotics was further tested by comparing two new combinations : thiothixene , 5 mg , and lorazepam , 4 mg , versus haloperidol , 5 mg , and phenobarbital sodium , 130 mg . These combinations had comparable efficacy and safety , and the level of transquilization approached that produced by the haloperidol-lorazepam combination in the preceding studies PURPOSE The Oncotype Dx Recurrence Score ( RS ) , is often employed in patients with estrogen receptor-positive , node negative ( ER+LN- ) breast cancer . We investigated the impact of the RS on actual chemotherapy administration and the effect of the assay on a panel of breast oncology experts . PATIENTS AND METHODS The prospect i ve adjuvant chemotherapy recommendations ( prior to RS ) and actual adjuvant therapy ( after RS ) for consecutive patients with ER+LN- breast cancer were recorded . After 6 months and with the same information , a panel of five experts made adjuvant therapy recommendations with and without RS and rated the strength of their recommendations . Rates of panel consensus , recommendation changes , and changes in recommendation strength were compared . RESULTS There were 29 patients ( 28 women ) . RS results altered the plan for chemotherapy in 9 patients ( 31 % ) ; 7 of 13 patients ( 54 % ) initially recommended for chemotherapy did not receive it , and 2 of 16 ( 13 % ) received chemotherapy following initial recommendations against it . RS results changed the panel 's chemotherapy recommendation in 7 patients ( 24 % ) : 5 of 12 ( 42 % ) recommendations for changed to against , and 2 of 17 ( 12 % ) recommendations against changed to for chemotherapy . RS increased consensus by the panel 10 % , but did not increase the reported strength in chemotherapy recommendations . CONCLUSIONS RS results were associated with real-world decision changes in 31 % of patients and 24 % of panel recommendations and increased panel consensus by 10 % . However RS did not increase the strength of panelist 's recommendations Background A few recent studies have found indications of the effectiveness of  inpatient psychotherapy  for depression , usually of an extended duration . However , there is a lack of controlled studies in this area and to date no study of adequate quality on brief psychodynamic psychotherapy for depression during short inpatient stay exists . The present article describes the protocol of a study that will examine the relative efficacy , the cost-effectiveness and the cost-utility of adding an Inpatient Brief Psychodynamic Psychotherapy to pharmacotherapy and treatment-as-usual for in patients with unipolar depression . Methods / Design The study is a one-month r and omized controlled trial with a two parallel group design and a 12-month naturalistic follow-up . A sample of 130 consecutive adult in patients with unipolar depression and Montgomery-Asberg Depression Rating Scale score over 18 will be recruited . The study is carried out in the university hospital section for mood disorders in Lausanne , Switzerl and . Patients are assessed upon admission , and at 1- , 3- and 12- month follow-ups . Inpatient therapy is a manualized brief intervention , combining the virtues of inpatient setting and of time-limited dynamic therapies ( focal orientation , fixed duration , re source -oriented interventions ) . Treatment-as-usual represents the best level of practice for a minimal treatment condition usually proposed to in patients . Final analyses will follow an intention – to-treat strategy . Depressive symptomatology is the primary outcome and secondary outcome includes measures of psychiatric symptomatology , psychosocial role functioning , and psychodynamic-emotional functioning . The mediating role of the therapeutic alliance is also examined . Allocation to treatment groups uses a stratified block r and omization method with permuted block . To guarantee allocation concealment , r and omization is done by an independent research er . Discussion Despite the large number of studies on treatment of depression , there is a clear lack of controlled research in inpatient psychotherapy during the acute phase of a major depressive episode . Research on brief therapy is important to take into account current short lengths of stay in psychiatry . The current study has the potential to scientifically inform appropriate inpatient treatment . This study is the first to address the issue of the economic evaluation of inpatient psychotherapy . Trial registration Australian New Zeal and Clinical Trial Registry ( ACTRN12612000909820 A r and omized , controlled , single-blinded , between group study of 24 participants with moderate to severe dementia was conducted on a geriatric psychiatric unit . All participants received pharmacological therapy , occupational therapy , structured hospital environment , and were r and omized to receive multi sensory behavior therapy ( MSBT ) or a structured activity session . Greater independence in activities of daily living ( ADLs ) was observed for the group treated with MSBT and st and ard psychiatric inpatient care on the Katz Index of Activities of Daily Living ( KI-ADL ; P = 0.05 ) than st and ard psychiatric inpatient care alone . The combination treatment of MSBT and st and ard psychiatric care also reduced agitation and apathy greater than st and ard psychiatric inpatient care alone as measured with the Pittsburgh Agitation Scale and the Scale for the Assessment of Negative Symptoms in Alzheimer 's Disease ( P = 0.05 ) . Multiple regression analysis predicted that within the multi-sensory group , activities of daily living ( KI-ADL ) increased as apathy and agitation reduced ( R2 = 0.42 ; p = 0.03 ) . These data suggest that utilizing MSBT with st and ard psychiatric inpatient care may reduce apathy and agitation and additionally improve activities of daily living in hospitalized people with moderate to severe dementia more than st and ard care alone STUDY OBJECTIVE To assess acute efficacy and safety of 9.75 mg of intramuscular ( IM ) injections of the atypical antipsychiatric aripiprazole in patients with schizophrenia or bipolar disorder and acute agitation . DESIGN Open-label trial of IM injections of aripiprazole and 24-hour monitoring of clinical response in patients with major psychoses and acute agitation . Partial analysis of blood levels of the administered drug to correlate with clinical response . SETTING Acute psychiatric care wards in a single university hospital . PATIENTS A total of 201 acutely agitated patients ( 79 with schizophrenia and 122 with bipolar disorder I ) . INTERVENTION Aripiprazole 9.75 mg IM injection . MEASUREMENTS AND MAIN RESULTS We evaluated clinical response using the Excitatory Component of the Positive and Negative Syndrome Scale ( PANSS-EC ) , the Agitation/Calmness Evaluation Scale ( ACES ) , and the Clinical Global Impressions scale ( CGI ) . Assessment s were conducted 30 , 60 , 90 , and 120 minutes and 24 hours after the first injection for PANSS-EC and ACES , and 2 , 4 , 6 , and 24 hours for CGI . Response was at least a 40 % decrease in PANSS-EC scores . We measured serum aripiprazole and dehydroaripiprazole levels in a sub sample . IM aripiprazole significantly improved clinical measures . PANSS-EC improved progressively , starting after 30 minutes . ACES improved after 90 minutes and continued thereafter . Effects were sustained , with steadily decreasing CGI scores , until the 24th hour . Response rate was 83.6 % after 2 hours , but with repeat injections , it rose to over 90 % with no differences among diagnostic groups . Although there were gender differences in the response to individual PANSS-EC items , the responses were similar overall . Neither clinical monitoring nor patient reporting revealed any side effects . No therapeutic window was identified , and levels did not correlate with any clinical measure . CONCLUSION Aripiprazole was effective and safe in reducing acute agitation in patients with bipolar disorder or schizophrenia . Our results compare favorably to double-blind trials , probably due to higher expectations in trials involving no placebo arm . Absence of side effects could be related to the short observation time In perinatal psychiatry , r and omized controlled trials are often not feasible on ethical grounds . Many studies are observational in nature , while others employ large data bases not design ed primarily for research purpose s. Quality assessment of the result ing research is complicated by a lack of st and ardized tools specifically for this purpose . The aim of this paper is to describe the  Systematic Assessment of Quality in Observational Research ( SAQOR )  , a quality assessment tool our team devised for a series of systematic review s and meta‐analyses of evidence ‐based literature regarding risks and benefits of antidepressant medication during pregnancy . Copyright © 2011 John Wiley & Sons , OBJECTIVE To evaluate the effectiveness of geriatric psychiatry consultation in reducing the severity of confusion , anxiety , depression , abnormal behavior , and functional disability among a selected group of aged medical and surgical in patients . DESIGN R and omized clinical trial . Cases assessed on enrollment at 2 , 4 , and 8 weeks later . SETTING Primary acute care hospital . PATIENTS Eighty hospitalized patients aged 65 or older who were referred to a multi-disciplinary team and had not received a psychiatric consultation in the month prior to referral . Sixty-three patients completed the trial . INTERVENTIONS Patients in the treatment group received a geriatric psychiatry consultation and , when appropriate , follow-up at least once per week for 8 weeks . Control patients received usual medical care . MAIN OUTCOME MEASURES Short Portable Mental Status Question naire , Anxiety Status Inventory , Geriatric Depression Rating Scale , and Crichton Geriatric Behavioral Rating Scale . RESULTS The effect of the consultation on psychiatric symptoms and functional status was positive but small . The differences in scores of all measures between treatment and control groups were not statistically significant , but there were consistent trends for more treatment than control cases to have improved on all measures , significantly so on the Anxiety Status Inventory ( P less than 0.05 ) . Cases with delirium or depression improved most often . More control than treatment cases were discharged after 4 and 8 weeks , but twice as many treatment cases were discharged home . CONCLUSIONS Geriatric psychiatry consultation , while not highly effective overall , may be beneficial if targeted to those most likely to benefit and compliance by referring physicians can be improved Objective : This study evaluated the 6-month outcome of patients referred by their general practitioner ( GP ) to a consultation-liaison ( C-L ) psychiatry service provided to eight group general practice s. Method : Over a 12-month period , there were 307 referrals to the C-L psychiatry service of whom 86 consented to take part in an outcome study . Two different control groups were examined comprising patients seen by the same GPs but not referred to the C-L service  , who were matched with the  C-L referrals  on the basis of either demographic characteristics ( n = 86 ) or initial symptomatology ( n = 59 ) . Clinical interviews were conducted at recruitment to the outcome study using the Composite International Diagnostic Interview ( CIDI ) , while postal question naires were used at both the initial and 6-month assessment s. Results : Data reported include DSM-Ill-R clinical audit and ClDl diagnoses , changes in current syrnptomatology ( SCL-904 ) and changes in global ratings of physical health , emotional health , social relationships and ability to perform everyday duties .  Consultation-liaison referrals without symptom-matched controls ( n = 27 ) , being patients with higher levels of symptoms initially , were more likely to be referred to other psychiatric services for treatment . They also showed more marked improvement over time on the selected outcome measures . However , there were no significant differences in the patterns of change overtime between symptom-matched C-L referrals and their non-referred controls . Conclusions : The findings from the 6-month outcome study raise doubts about the overall benefit of the current C-L service relative to usual GP care . Improving the quality of psychiatric care in general practice is likely to require a range of interrelated strategies , including C-L psychiatry services , GP education and well-functioning links with public mental health services
For its management , experts agreed in considering  verbal de-escalation  and  environmental modification techniques  as first choice , considering physical restraint as a last resort strategy .
BACKGROUND Psychomotor agitation is associated with different psychiatric conditions and represents an important issue in psychiatry .
Current recommendations on agitation in psychiatry are not univocal .
Actually , an improper assessment and management may result in unnecessary coercive or sedative treatments .
A thorough and balanced review plus an expert consensus can guide assessment and treatment decisions .