scholarly journals Crisis-planning interventions for people with psychotic illness or bipolar disorder: systematic review and meta-analyses

BJPsych Open ◽  
2019 ◽  
Vol 5 (4) ◽  
Author(s):  
Emma Molyneaux ◽  
Amelia Turner ◽  
Bridget Candy ◽  
Sabine Landau ◽  
Sonia Johnson ◽  
...  
Keyword(s):  
Mental Health ◽  
Bipolar Disorder ◽  
Usual Care ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Crisis Planning ◽  
Psychotic Illness ◽  
Health Crisis ◽  
Psychiatric Admissions ◽  
Secondary Outcomes

Background Mental health services lack a strong evidence base on the most effective interventions to reduce compulsory admissions. However, some research suggests a positive impact of crisis-planning interventions in which patients are involved in planning for their future care during a mental health crisis. Aims This review aimed to synthesise randomised controlled trial (RCT) evidence on the effectiveness of crisis-planning interventions (for example advance statements and joint crisis plans) in reducing rates of compulsory hospital admissions for people with psychotic illness or bipolar disorder, compared with usual care (PROSPERO registration number: CRD42018084808). Method Six online databases were searched in October 2018. The primary outcome was compulsory psychiatric admissions and secondary outcomes included other psychiatric admissions, therapeutic alliance, perceived coercion and cost-effectiveness. Bias was assessed using the Cochrane collaboration tool. Results The search identified 1428 studies and 5 RCTs were eligible. One study had high risk of bias because of incomplete primary outcome data. Random-effects meta-analysis showed a 25% reduction in compulsory admissions for those receiving crisis-planning interventions compared with usual care (risk ratio 0.75, 95% CI 0.61–0.93, P = 0.008; from five studies). There was no statistical evidence that the intervention reduced the risk of voluntary or combined voluntary and compulsory psychiatric admissions. Few studies assessed other secondary outcomes. Conclusions Our meta-analysis suggests that crisis-planning interventions substantially reduce the risk of compulsory admissions among individuals with psychotic illness or bipolar disorder. Despite common components, interventions varied in their content and intensity across the trials. The optimal models and implementation of these interventions require further investigation. Declaration of interest E.M., S.L., S.J. and B.L.-E. received funding from the National Institute for Health Research during the conduct of the study.

scholarly journals Intermediate-to-therapeutic versus prophylactic anticoagulation for coagulopathy in hospitalized COVID-19 patients: a systemic review and meta-analysis

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Sirui Zhang ◽  
Yupei Li ◽  
Guina Liu ◽  
Baihai Su
Keyword(s):  
Hospital Mortality ◽  
Major Bleeding ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Pooled Analysis ◽  
Bleeding Events ◽  
Risk Of Bleeding ◽  
Therapeutic Anticoagulation ◽  
Secondary Outcomes ◽  
Prophylactic Anticoagulation

Abstract Background Anticoagulation in hospitalized COVID-19 patients has been associated with survival benefit; however, the optimal anticoagulant strategy has not yet been defined. The objective of this meta-analysis was to investigate the effect of intermediate-to-therapeutic versus prophylactic anticoagulation for thromboprophylaxis on the primary outcome of in-hospital mortality and other patient-centered secondary outcomes in COVID-19 patients. Methods MEDLINE, EMBASE, and Cochrane databases were searched from inception to August 10th 2021. Cohort studies and randomized clinical trials that assessed the efficacy and safety of intermediate-to-therapeutic versus prophylactic anticoagulation in hospitalized COVID-19 patients were included. Baseline characteristics and relevant data of each study were extracted in a pre-designed standardized data-collection form. The primary outcome was all-cause in-hospital mortality and the secondary outcomes were incidence of thrombotic events and incidence of any bleeding and major bleeding. Pooled analysis with random effects models yielded relative risk with 95 % CIs. Results This meta-analysis included 42 studies with 28,055 in-hospital COVID-19 patients totally. Our pooled analysis demonstrated that intermediate-to-therapeutic anticoagulation was not associated with lower in-hospital mortality (RR=1.12, 95 %CI 0.99-1.25, p=0.06, I2=77 %) and lower incidence of thrombotic events (RR=1.30, 95 %CI 0.79-2.15, p=0.30, I2=88 %), but increased the risk of any bleeding events (RR=2.16, 95 %CI 1.79-2.60, p<0.01, I2=31 %) and major bleeding events significantly (RR=2.10, 95 %CI 1.77-2.51, p<0.01, I2=11 %) versus prophylactic anticoagulation. Moreover, intermediate-to-therapeutic anticoagulation decreased the incidence of thrombotic events (RR=0.71, 95 %CI 0.56-0.89, p=0.003, I2=0 %) among critically ill COVID-19 patients admitted to intensive care units (ICU), with increased bleeding risk (RR=1.66, 95 %CI 1.37-2.00, p<0.01, I2=0 %) and unchanged in-hospital mortality (RR=0.94, 95 %CI 0.79-1.10, p=0.42, I2=30 %) in such patients. The Grading of Recommendation, Assessment, Development, and Evaluation certainty of evidence ranged from very low to moderate. Conclusions We recommend the use of prophylactic anticoagulation against intermediate-to-therapeutic anticoagulation among unselected hospitalized COVID-19 patients considering insignificant survival benefits but higher risk of bleeding in the escalated thromboprophylaxis strategy. For critically ill COVID-19 patients, the benefits of intermediate-to-therapeutic anticoagulation in reducing thrombotic events should be weighed cautiously because of its association with higher risk of bleeding. Trial registration The protocol was registered at PROSPERO on August 17th 2021 (CRD42021273780). Graphical abstract

scholarly journals Randomised feasibility trial of the helping families programme-modified: an intensive parenting intervention for parents affected by severe personality difficulties

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e033637 ◽  
Author(s):  
Crispin Day ◽  
Jackie Briskman ◽  
Mike J Crawford ◽  
Lisa Foote ◽  
Lucy Harris ◽  
...  
Keyword(s):  
Mental Health ◽  
Usual Care ◽  
Child Mental Health ◽  
Parenting Intervention ◽  
Child Behaviour ◽  
Feasibility Trial ◽  
Random Allocation ◽  
Secondary Outcomes ◽  
Participant Retention ◽  
Capacity For Consent

BackgroundSpecialist parenting intervention could improve coexistent parenting and child mental health difficulties of parents affected by severe personality difficulties.ObjectiveConduct a feasibility trial of Helping Families Programme-Modified (HFP-M), a specialist parenting intervention.DesignPragmatic, mixed-methods trial, 1:1 random allocation, assessing feasibility, intervention acceptability and outcome estimates.SettingsTwo National Health Service health trusts and local authority children’s social care.ParticipantsParents: (i) primary caregiver, (ii) 18 to 65 years, (iii) severe personality difficulties, (iv) proficient English and (v) capacity for consent. Child: (i) 3 to 11 years, (ii) living with index parent and (iii) significant emotional/behavioural difficulties.InterventionHFP-M: 16-session home-based intervention using parenting and therapeutic engagement strategies. Usual care: standard care augmented by single psychoeducational parenting session.OutcomesPrimary feasibility outcome: participant retention rate. Secondary outcomes: (i) rates of recruitment, eligibility and data completion, and (ii) rates of intervention acceptance, completion and alliance (Working Alliance Inventory-Short Revised). Primary clinical outcome: child behaviour (Eyberg Child Behaviour Inventory). Secondary outcomes: child mental health (Concerns About My Child, Child Behaviour Checklist-Internalising Scale), parenting (Arnold-O’Leary Parenting Scale, Kansas Parental Satisfaction Scale) and parent mental health (Symptom-Checklist-27). Quantitative data were collected blind to allocation.ResultsFindings broadly supported non-diagnostic selection criterion. Of 48 participants recruited, 32 completed post-intervention measures at mean 42 weeks later. Participant retention exceeded a priori rate (HFP-M=18; Usual care=14; 66.7%, 95% CI 51.6% to 79.6%). HFP-M was acceptable, with delivery longer than planned. Usual care had lower alliance rating. Child and parenting outcome effects detected across trial arms with potential HFP-M advantage (effect size range: 0.0 to 1.3).ConclusionHFP-M is an acceptable and potentially effective specialist parenting intervention. A definitive trial is feasible, subject to consideration of recruitment and retention methods, intervention efficiency and comparator condition. Caution is required in interpretation of results due to reduced sample size. No serious adverse events reported.Trial registration numberISRCTN14573230

scholarly journals Cognitive behavioural therapy significantly reduces anxiety in patients with implanted cardioverter defibrillator compared with usual care: Findings from the Screen-ICD randomised controlled trial

2019 ◽  
Vol 27 (3) ◽  
pp. 258-268 ◽  
Author(s):  
Selina K Berg ◽  
Trine B Rasmussen ◽  
Margrethe Herning ◽  
Jesper H Svendsen ◽  
Anne V Christensen ◽  
...  
Keyword(s):  
Usual Care ◽  
Cognitive Behavioural Therapy ◽  
Primary Outcome ◽  
Depression Scale ◽  
Behavioural Therapy ◽  
Anxiety And Depression ◽  
Hospital Anxiety ◽  
Cardioverter Defibrillator ◽  
Cognitive Behavioural ◽  
Secondary Outcomes

Aim The aim of this study was to investigate the effect of a cognitive behavioural therapy intervention provided by trained cardiac nurses plus usual care compared with usual care alone in patients with an implanted cardioverter defibrillator who, prior to randomization, had presented with symptoms of anxiety measured by the Hospital Anxiety and Depression Scale. Background Around 20–25% of all patients with an implanted cardioverter defibrillator experience anxiety. Among these patients anxiety is associated with mortality, presumably explained by risk behaviour and activation of the autonomic nervous system. We hypothesised that cognitive behavioural therapy provided by cardiac nurses in an out-patient setting would be an effective treatment of anxiety. Methods This was an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive behavioural therapy plus usual care or to usual care. The primary outcome was Hospital Anxiety and Depression Scale-Anxiety mean score at 16 weeks. Secondary outcomes included Hospital Anxiety and Depression Scale-Depression, Becks Anxiety Inventory, HeartQoL and Hamilton Anxiety Scale. Primary outcome analysis was based on the intention-to-treat principle. Results A total of 88 participants were included, 66% men, mean age 64.3 years and 61% had primary indication implantable cardioverter defibrillator. A significant difference after 16 weeks was found between groups: intervention group (Hospital Anxiety and Depression Scale-A mean (standard deviation) 4.95 points (3.30) versus usual care group 8.98 points (4.03) ( p < 0.0001)). Cohen's d was –0.86, indicating a strong clinical effect. The effect was supported by secondary outcomes. Conclusion Cognitive behavioural therapy provided by cardiac nurses to patients with a positive screening for anxiety had a statistically and clinically significant effect on anxiety compared with patients not receiving cognitive behavioural therapy.

scholarly journals Preventing sickness absence among employees with common mental disorders or stress-related symptoms at work: a cluster randomised controlled trial of a problem-solving-based intervention conducted by the Occupational Health Services

2020 ◽  
Vol 77 (7) ◽  
pp. 454-461 ◽  
Author(s):  
Marijke Keus van de Poll ◽  
Lotta Nybergh ◽  
Caroline Lornudd ◽  
Jan Hagberg ◽  
Lennart Bodin ◽  
...  
Keyword(s):  
Mental Health ◽  
Problem Solving ◽  
Mental Disorders ◽  
Occupational Health ◽  
Sickness Absence ◽  
Primary Outcome ◽  
Common Mental Disorders ◽  
Significant Group ◽  
Secondary Outcomes

ObjectivesCommon mental disorders (CMDs) are among the main causes of sickness absence and can lead to suffering and high costs for individuals, employers and the society. The occupational health service (OHS) can offer work-directed interventions to support employers and employees. The aim of this study was to evaluate the effect on sickness absence and health of a work-directed intervention given by the OHS to employees with CMDs or stress-related symptoms.MethodsRandomisation was conducted at the OHS consultant level and each consultant was allocated into either giving a brief problem-solving intervention (PSI) or care as usual (CAU). The study group consisted of 100 employees with stress symptoms or CMDs. PSI was highly structured and used a participatory approach, involving both the employee and the employee’s manager. CAU was also work-directed but not based on the same theoretical concepts as PSI. Outcomes were assessed at baseline, at 6 and at 12 months. Primary outcome was registered sickness absence during the 1-year follow-up period. Among the secondary outcomes were self-registered sickness absence, return to work (RTW) and mental health.ResultsA statistical interaction for group × time was found on the primary outcome (p=0.033) and PSI had almost 15 days less sickness absence during follow-up compared with CAU. Concerning the secondary outcomes, PSI showed an earlier partial RTW and the mental health improved in both groups without significant group differences.ConclusionPSI was effective in reducing sickness absence which was the primary outcome in this study.

scholarly journals Efficiency and safety of ondansetron in preventing postanaesthesia shivering

2016 ◽  
Vol 98 (6) ◽  
pp. 358-366 ◽  
Author(s):  
k He ◽  
H Zhao ◽  
HC Zhou
Keyword(s):  
Lower Risk ◽  
Randomised Controlled Trials ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Meta Analysis ◽  
Primary Outcome Measure ◽  
Cochrane Library ◽  
Significant Difference ◽  
Secondary Outcomes ◽  
Randomised Controlled

Introduction Shivering is one of the most frequent complications of operation during the postanaesthesia period. Ondansetron has been proved to be valid in preventing postanaesthesia shivering (PAS) in several studies. However, its efficiency and safety are still disputable. We therefore performed an updated meta-analysis of randomised controlled trials (RCTs) for evaluation and to clarify this issue. Methods A literature search using the PubMed, Embase™ and Cochrane Library databases was performed (from inception to January 2015). RCTs that evaluated the efficiency and safety of ondansetron in the prevention of PAS were included in the meta-analysis. The primary outcome measure was incidence of PAS, and secondary outcomes included subgroup analysis and the side effects of ondansetron. Results A total of 8 RCTs containing 905 subjects were identified as suitable for this review. Compared with placebo, ondansetron was associated with a significant reduction of PAS (relative risk [RR]: 0.33, 95% confidence interval [CI]: 0.19–0.58, p=0.0001) while no difference was detected between ondansetron and pethidine (RR: 0.89, 95% CI: 0.41–1.94, p=0.78). There was no significant difference between ondansetron and placebo or pethidine in terms of risk of bradycardia but ondansetron was associated with a lower risk of hypotension (RR: 0.26, 95% CI: 0.08–0.79, p=0.020) than placebo. There was no difference in hypotension when ondansetron was compared with pethidine. Conclusions Ondansetron can prevent PAS effectively and reduce the risk of hypotension.

scholarly journals Home-based rehabilitation programme compared with traditional physiotherapy for patients at risk of poor outcome after knee arthroplasty: the CORKA randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e052598
Author(s):  
Karen L Barker ◽  
Jonathan Room ◽  
Ruth Knight ◽  
Susan Dutton ◽  
Francine Toye ◽  
...  
Keyword(s):  
At Risk ◽  
Usual Care ◽  
Outcome Measures ◽  
Knee Arthroplasty ◽  
Primary Outcome ◽  
Rehabilitation Programme ◽  
Poor Outcome ◽  
Home Based ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectivesTo evaluate whether a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty offers superior outcomes to traditional outpatient physiotherapy.DesignA prospective, single-blind, two-arm randomised controlled superiority trial.Setting14 National Health Service physiotherapy departments in the UK.Participants621 participants identified at high risk of a poor outcome after knee arthroplasty using a bespoke screening tool.InterventionsA multicomponent home-based rehabilitation programme delivered by rehabilitation assistants with supervision from qualified therapists versus usual care outpatient physiotherapy.Main outcome measuresThe primary outcome was the Late-Life Function and Disability Instrument (LLFDI) at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function), Knee injury and Osteoarthritis Outcome Score Quality of Life subscale, Physical Activity Scale for the Elderly, 5 dimension, 5 level version of Euroqol (EQ-5D-5L) and physical function assessed using the Figure of 8 Walk test, 30 s Chair Stand Test and Single Leg Stance.Results621 participants were randomised between March 2015 and January 2018. 309 were assigned to CORKA (Community Rehabilitation after Knee Arthroplasty) home-based rehabilitation, receiving a median five treatment sessions (IQR 4–7). 312 were assigned to usual care, receiving a median 4 sessions (IQR 2–6). The primary outcome, LLFDI function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference=0.49 points; 95% CI −0.89 to 1.88; p=0.48). There were no statistically significant differences between the groups on any of the patient-reported or physical secondary outcome measures at 6 or 12 months.There were 18 participants in the intervention group reporting a serious adverse event (5.8%), only one directly related to the intervention, all other adverse events recorded throughout the trial related to underlying chronic medical conditions.ConclusionsThe CORKA intervention was not superior to usual care. The trial detected no significant differences, clinical or statistical, between the two groups on either primary or secondary outcomes. CORKA offers an evaluation of an intervention utilising a different service delivery model for this patient group.Trial registration numberISRCTN13517704.

scholarly journals Multicentre cluster randomised trial comparing a community group exercise programme and home-based exercise with usual care for people aged 65 years and over in primary care

2014 ◽  
Vol 18 (49) ◽  
pp. 1-106 ◽  
Author(s):  
Steve Iliffe ◽  
Denise Kendrick ◽  
Richard Morris ◽  
Tahir Masud ◽  
Heather Gage ◽  
...  
Keyword(s):  
Physical Activity ◽  
Primary Care ◽  
Usual Care ◽  
Primary Outcome ◽  
Health Technology ◽  
Exercise Programme ◽  
Cluster Randomised ◽  
Home Based ◽  
General Practices ◽  
Secondary Outcomes

BackgroundRegular physical activity (PA) reduces the risk of falls and hip fractures, and mortality from all causes. However, PA levels are low in the older population and previous intervention studies have demonstrated only modest, short-term improvements.ObjectiveTo evaluate the impact of two exercise promotion programmes on PA in people aged ≥ 65 years.DesignThe ProAct65+ study was a pragmatic, three-arm parallel design, cluster randomised controlled trial of class-based exercise [Falls Management Exercise (FaME) programme], home-based exercise [Otago Exercise Programme (OEP)] and usual care among older people (aged ≥ 65 years) in primary care.SettingForty-three UK-based general practices in London and Nottingham/Derby.ParticipantsA total of 1256 people ≥ 65 years were recruited through their general practices to take part in the trial.InterventionsThe FaME programme and OEP. FaME included weekly classes plus home exercises for 24 weeks and encouraged walking. OEP included home exercises supported by peer mentors (PMs) for 24 weeks, and encouraged walking.Main outcome measuresThe primary outcome was the proportion that reported reaching the recommended PA target of 150 minutes of moderate to vigorous physical activity (MVPA) per week, 12 months after cessation of the intervention. Secondary outcomes included functional assessments of balance and falls risk, the incidence of falls, fear of falling, quality of life, social networks and self-efficacy. An economic evaluation including participant and NHS costs was embedded in the clinical trial.ResultsIn total, 20,507 patients from 43 general practices were invited to participate. Expressions of interest were received from 2752 (13%) and 1256 (6%) consented to join the trial; 387 were allocated to the FaME arm, 411 to the OEP arm and 458 to usual care. Primary outcome data were available at 12 months after the end of the intervention period for 830 (66%) of the study participants.The proportions reporting at least 150 minutes of MVPA per week rose between baseline and 12 months after the intervention from 40% to 49% in the FaME arm, from 41% to 43% in the OEP arm and from 37.5% to 38.0% in the usual-care arm. A significantly higher proportion in the FaME arm than in the usual-care arm reported at least 150 minutes of MVPA per week at 12 months after the intervention [adjusted odds ratio (AOR) 1.78, 95% confidence interval (CI) 1.11 to 2.87;p = 0.02]. There was no significant difference in MVPA between OEP and usual care (AOR 1.17, 95% CI 0.72 to 1.92;p = 0.52). Participants in the FaME arm added around 15 minutes of MVPA per day to their baseline physical activity level. In the 12 months after the close of the intervention phase, there was a statistically significant reduction in falls rate in the FaME arm compared with the usual-care arm (incidence rate ratio 0.74, 95% CI 0.55 to 0.99;p = 0.042). Scores on the Physical Activity Scale for the Elderly showed a small but statistically significant benefit for FaME compared with usual care, as did perceptions of benefits from exercise. Balance confidence was significantly improved at 12 months post intervention in both arms compared with the usual-care arm. There were no statistically significant differences between intervention arms and the usual-care arm in other secondary outcomes, including quality-adjusted life-years. FaME is more expensive than OEP delivered with PMs (£269 vs. £88 per participant in London; £218 vs. £117 in Nottingham). The cost per extra person exercising at, or above, target was £1919.64 in London and £1560.21 in Nottingham (mean £1739.93).ConclusionThe FaME intervention increased self-reported PA levels among community-dwelling older adults 12 months after the intervention, and significantly reduced falls. Both the FaME and OEP interventions appeared to be safe, with no significant differences in adverse reactions between study arms.Trial registrationThis trial is registered as ISRCTN43453770.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 18, No. 49. See the NIHR Journals Library website for further project information.

Acupuncture for tinnitus: a systematic review and meta-analysis of randomized controlled trials

2020 ◽  
pp. 096452842093838 ◽  
Author(s):  
Kaiyu Huang ◽  
Shuang Liang ◽  
Lei Chen ◽  
Antoine Grellet
Keyword(s):  
Randomized Controlled Trials ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Small Sample ◽  
Controlled Trials ◽  
Control Groups ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Vas Score ◽  
Secondary Outcomes

Objective: To evaluate the efficacy/effectiveness of acupuncture for the treatment of tinnitus. Methods: Four English and four Chinese databases were searched for randomized controlled trials (RCTs) of acupuncture for tinnitus published before 30 September 2018. RCTs applying acupuncture alone compared with conventional treatments, sham acupuncture, or no treatment, as well as acupuncture plus conventional treatments compared with conventional treatments alone, were included. The primary outcome was the visual analogue scale (VAS). Secondary outcomes included tinnitus handicap inventory (THI) and tinnitus severity index (TSI) scores. Meta-analysis was conducted using RevMan V5.3 software. The protocol was registered in the PROSPERO database (ref. CRD42018108692). Results: Eight studies involving 504 participants were included. Meta-analysis showed no significant differences in the VAS score (mean difference (MD) = −1.81, 95% confidence interval (CI) = −3.69 to 0.07; p = 0.06) between the acupuncture and control groups. However, favorable effects of acupuncture on changes in THI score (MD = −10.11, 95% CI = −12.74 to −7.48; p < 0.001) and TSI score (MD = −8.36, 95% CI = −8.87 to −7.86; p < 0.001) were found. Conclusion: Acupuncture had no significant effect on the primary outcome of VAS score compared with control treatment; however, positive effects on secondary outcomes (THI and TSI score) were observed in acupuncture versus control groups. Due to the low quality and small sample size of the included trials, the level of evidence was insufficient to draw any definitive conclusions. Further rigorous and high-quality studies with larger sample sizes should be conducted to confirm the efficacy/effectiveness of acupuncture for tinnitus.

scholarly journals Droperidolv. haloperidol for sedation of aggressive behaviour in acute mental health: Randomised controlled trial

2015 ◽  
Vol 206 (3) ◽  
pp. 223-228 ◽  
Author(s):  
Leonie Calver ◽  
Vincent Drinkwater ◽  
Rahul Gupta ◽  
Colin B. Page ◽  
Geoffrey K. Isbister
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Behavioural Disturbance ◽  
Significant Difference ◽  
Psychiatric Units ◽  
Secondary Outcomes ◽  
Randomised Controlled ◽  
Effective Sedation

BackgroundAgitation and aggression are significant problems in acute psychiatric units. There is little consensus on which drug is most effective and safest for sedation of these patients.AimsTo compare the effectiveness and safety of haloperidolv. droperidol for patients with agitation and aggression.MethodIn a masked, randomised controlled trial (ACTRN12611000565943) intramuscular droperidol (10 mg) was compared with intramuscular haloperidol (10 mg) for adult patients with acute behavioural disturbance in a psychiatric intensive care unit. The primary outcome was time to sedation within 120 min. Secondary outcomes were use of additional sedation, adverse events and staff injuries.ResultsFrom 584 patients, 110 were randomised to haloperidol and 118 to droperidol. Effective sedation occurred in 210 (92%) patients within 120 min. There was no significant difference in median time to sedation: 20 min (interquartile range 15–30, range 10–75) for haloperidolv. 25 min (IQR 15–30, range 10–115) for droperidol (P= 0.89). Additional sedation was used more often with haloperidol (13%v. 5%,P= 0.06), but adverse effects were less common with haloperidol (1%v. 5%,P= 0.12). There were 8 staff injuries.ConclusionsBoth haloperidol and droperidol were effective for sedation of patients with acute behavioural disturbance.

scholarly journals Economic evaluation protocol of two randomized trials of a mHealth Intervention for noncommunicable diseases patients with depressive symptoms in São Paulo, Brazil, and Lima, Peru (Preprint)

2020 ◽  
Author(s):  
Daniela Vera Cruz dos Santos ◽  
Patrícia Coelho de Soárez ◽  
Victoria Cavero ◽  
Thais Ugeda Rocha ◽  
Suzana Crismanis Almeida Lopes Aschar ◽  
...  
Keyword(s):  
Public Health ◽  
Mental Health ◽  
Depressive Symptoms ◽  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Incremental Cost ◽  
Usual Care ◽  
Primary Outcome ◽  
Sao Paulo ◽  
The Cost

BACKGROUND Mobile health (mHealth) interventions provide significant strategies for improving access to health services [1], offering one potential solution to reduce the mental health treatment gap. Economic evaluation can contribute with evidence to the local policy of and program development in mental health. OBJECTIVE This paper presents the protocol for an economic evaluation conducted alongside two randomized controlled trials (RCTs) to evaluate the effectiveness of a psychological intervention delivered through a technological platform (CONEMO) to treat depressive symptoms in people with diabetes and/or hypertension. METHODS The economic evaluation uses a within-trial analysis to evaluate the incremental costs and health outcomes of CONEMO compared to usual enhanced care from society and public health system perspectives. We recruited participants from the public health systems in Sao Paulo, Brazil (n=880), and Lima, Peru (n=432), and randomized to intervention or enhanced usual care groups RCTs. We will conduct cost-effectiveness and cost-utility analyses, providing estimates of the cost to decrease depressive symptoms by 50% or more. The cost per quality-adjusted life-year (QALY) gained. For effectiveness, our primary outcome is the proportion of participants with a 50% reduction in the Patient Health Questionnaire (PHQ- 9) score at 3-month - calculated through logistic regression. For utility, our primary outcome is the QALYs gained, measured by the EQ-5D-3L. We assessed each dimension at months 3 and 6. Costs will include both direct and indirect costs. The method of measurement will be mixed methods, with a combination of the Top-down and Bottom-up approaches. We will collect unit costs from the RCTs and national administrative databases. We will also calculate incremental cost-effectiveness ratios (ICERs) and display 95% confidence intervals (CI) from non-parametric bootstrapping (1000 replicates). We will calculate the incremental cost-effectiveness rate, as well as a deterministic and probabilistic sensitivity analysis. Finally, we will draw a Cost-Effectiveness Acceptability Curve (CEAC) to compare a range of possible cost-effectiveness limits. RESULTS The economic evaluation project had its project charter in June 2018 and is expected to be completed in September 2021. The final results will be available in the second half of 2021. CONCLUSIONS We expect to assess if CONEMO plus enhanced usual care is a cost-effective strategy to improve depressive symptoms in this population compared to usual enhanced care. This study will assist health managers in allocating additional resources for mental health initiatives and will inform policymakers. It also provides a basis for further research on how this emerging technology and enhanced usual care can improve mental health and well-being in low-income settings. CLINICALTRIAL ClinicalTrials.gov - Brazil NCT02846662 and Peru NCT03026426

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