Can we reduce the need for coercive interventions?

2017 ◽  
Author(s):  
George Szmukler
Keyword(s):  
Complex Interventions ◽  
Psychiatric Hospitals ◽  
The United States ◽  
Treatment Preferences ◽  
Controlled Trials ◽  
Treatment Team ◽  
Crisis Plans ◽  
Coercive Measures ◽  
Randomized Controlled ◽  
Inpatient Units

Sadly, little research has been devoted to developing interventions aimed at reducing the use of coercive measures. A large study in the United States showed that patient perceptions of coercion at admission to psychiatric hospitals are less if they believe their ‘voice’ has been heard, and they have been treated with respect, concern, and in good faith—termed ‘procedural justice’. However, trials of whether training staff in accord with these observations will reduce coercion have yet to be done. The most promising interventions to reduce involuntary admissions have been ‘joint crisis plans’. These offer opportunities for patients to state their treatment preferences in case of future crises, and plans are negotiated in joint meetings with the treatment team. Though randomized controlled trials are lacking, ‘before versus after’ comparisons have suggested a range of complex interventions that may reduce the use of coercive measures, such as restraint and seclusion, on inpatient units.

scholarly journals Variables Associated with the Use of Coercive Measures on Psychiatric Patients in Spanish Penitentiary Centers

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
E. Girela ◽  
A. López ◽  
L. Ortega ◽  
J. De-Juan ◽  
F. Ruiz ◽  
...  
Keyword(s):  
Mentally Ill ◽  
Psychiatric Patients ◽  
Psychiatric Inpatient ◽  
Psychiatric Hospitals ◽  
Coercive Measure ◽  
Coercive Measures ◽  
External Assessment ◽  
Mechanical Restraint ◽  
The Family ◽  
Inpatient Units

We have studied the use of coercive medical measures (forced medication, isolation, and mechanical restraint) in mentally ill inmates within two secure psychiatric hospitals (SPH) and three regular prisons (RP) in Spain. Variables related to adopted coercive measures were analyzed, such as type of measure, causes of indication, opinion of patient inmate, opinion of medical staff, and more frequent morbidity. A total of 209 patients (108 from SPH and 101 from RP) were studied. Isolation (41.35%) was the most frequent coercive measure, followed by mechanical restraint (33.17%) and forced medication (25.48%). The type of center has some influence; specifically in RP there is less risk of isolation and restraint than in SPH. Not having had any previous imprisonment reduces isolation and restraint risk while increases the risk of forced medication, as well as previous admissions to psychiatric inpatient units does. Finally, the fact of having lived with a partner before imprisonment reduces the risk of forced medication and communication with the family decreases the risk of isolation. Patients subjected to a coercive measure exhibited a pronounced psychopathology and most of them had been subjected to such measures on previous occasions. The mere fact of external assessment of compliance with human rights slows down the incidence of coercive measures.

Randomized controlled trials

2020 ◽  
pp. 187-218
Author(s):  
Sube Banerjee ◽  
Rod S. Taylor ◽  
Jennifer Hellier
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trials ◽  
Complex Interventions ◽  
Controlled Trials ◽  
Key Factors ◽  
Randomized Controlled ◽  
Study Population ◽  
Primary Hypothesis ◽  
Definition Of

This chapter on randomized controlled trials (RCTs) considers some of the key factors in the design, conduct, analysis, and interpretation of RCTs. The chapter provides an overview of what constitutes an RCT and why they are needed. The chapter also provides an overview of the major practical elements of the design and conduct of RCTs, including undertaking a background review of literature, the need for formulation of a clear primary hypothesis and objective, selection and definition of the study population, collecting outcomes at baseline and follow-up, and appropriate methods of statistical analysis and inference. The chapter concludes with a consideration of the need for clinical trial units, complex interventions, and alternative RCT designs.

scholarly journals Designing and Evaluating Culturally Specific Smoking Cessation Interventions for American Indian Communities

2013 ◽  
Vol 16 (1) ◽  
pp. 42-49 ◽  
Author(s):  
Steven S. Fu ◽  
Kristine L. Rhodes ◽  
Christina Robert ◽  
Rachel Widome ◽  
Jean L. Forster ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
American Indian ◽  
Randomized Controlled Trials ◽  
American Indians ◽  
The United States ◽  
Controlled Trials ◽  
Culturally Specific ◽  
Indian Community ◽  
Randomized Controlled ◽  
American Indian Community

Abstract Introduction: American Indians have the highest smoking rates in the United States, yet few randomized controlled trials of culturally specific interventions exist. This study assessed American Indians’ opinions about evidence-based treatment and attitudes toward participating in clinical trials. Methods: Six focus groups were conducted based on smoking status (current/former smoker), sex, and elder status (55 years and older or younger). Meetings were held at local American Indian community organizations. This project was accomplished in partnership with the American Indian Community Tobacco Projects, a community–academic research partnership at the University of Minnesota. Thematic qualitative data analyses were conducted. Results: Participants desired the following: (a) programs led by trained American Indian community members, (b) the opportunity to connect with other American Indian smokers interested in quitting, and (c) programs promoting healthy lifestyles. Strategies desired for treatment included (a) free pharmacotherapy, including nicotine replacement therapy (NRT); (b) nominal incentives, e.g., gift cards for groceries; and (c) culturally specific program components such as American Indian images, education on traditional tobacco use, and quit-smoking messages that target the value of family and include narratives or story telling in recruitment and program materials. Biochemical verification of smoking abstinence, such as salivary cotinine or carbon monoxide breathalyzers, is likely acceptable. Standard treatment or delayed treatment control groups were viewed as potentially acceptable for randomized study designs. Conclusions: Rigorously conducted randomized controlled trials of culturally specific smoking cessation interventions are sorely needed but will only be accomplished with the commitment of funders, researchers, and collaborative trusting relationships with the community.

scholarly journals Are Randomized Controlled Trials Controlled? Patient Preferences and Unblind Trials

1997 ◽  
Vol 90 (12) ◽  
pp. 652-656 ◽  
Author(s):  
Klim Mcpherson ◽  
Annie R Britton ◽  
John E Wennberg
Keyword(s):  
Randomized Controlled Trials ◽  
Patient Preferences ◽  
Treatment Effects ◽  
Evidence Base ◽  
Modern Medicine ◽  
Treatment Preferences ◽  
Controlled Trials ◽  
True Nature ◽  
Randomized Controlled ◽  
Catch 22

The most reliable information about treatment effects comes from randomized controlled trials (RCTs). However, the possibility of subtle interactions—for example, between treatment preferences and treatment effects—is generally subordinated in the quest for evidence about main treatment effects. If patient preferences can influence the effectiveness of treatments through poorly understood (psychological) pathways, then RCTs, particularly when unblinded, may wrongly attribute effects solely to a treatment's physiological/pharmacological properties. To interpret the RCT evidence base it is important to know whether any preference effects exist and, if so, by how much they affect outcome. Reliable measurement of these effects is difficult and will require new approaches to the conduct of trials. In view of the fanciful image with which such effects are portrayed and the uncertainties about their true nature and biological mechanisms, existing evidence is unlikely to provide sufficient justification for investment in trials. This is a Catch 22. Until an escape is found we might never know, even approximately, how much of modern medicine is attributable to psychological processes.

scholarly journals Review of Pro- and/or Prebiotics in Extensively Hydrolyzed or Amino Acid-Based Infant Formula for Food Allergy

2017 ◽  
Vol 11 (1) ◽  
pp. 27-38
Author(s):  
Nichole Giardina ◽  
Barbara Marriage
Keyword(s):  
Food Allergy ◽  
Amino Acid ◽  
Randomized Controlled Trials ◽  
Inflammatory Responses ◽  
The United States ◽  
Health Concern ◽  
Current Evidence ◽  
Controlled Trials ◽  
Advantages And Disadvantages ◽  
Randomized Controlled

Background:The incidence of food allergy is a growing health concern in the United States. Research suggests that there is a link between the gut microbiota and the development of allergy. As a result, researchers propose that gut microbial populations could affect the development and management of immunological disease.Objectives:The purpose of this review is to present current evidence of the advantages and disadvantages of probiotic and/or prebiotic addition to extensively hydrolyzed protein (EHF) and amino acid-based infant formulas (AAF) for the management of food allergy.Method:Only randomized controlled trials were included for review. The randomized controlled trials were limited to human subjects less than 12 years of age with a confirmed case of food allergy who were consuming EHF or AAF supplemented with probiotics and/or prebiotics.Results:Eleven studies were included for review. Probiotic and synbiotic addition was associated with an improvement in SCORAD index in EHF and AAF, and EHF significantly moderated immunologic and/or inflammatory responses. Probiotic addition to EHF benefited patients exhibiting hematochezia, and synbiotic addition resulted in softer stool, higher stool frequency, and decreased incidence of infection in some studies.Conclusion:Although few studies report statistically significant effects upon feeding prebiotics or probiotics with EHF and AAF on food allergy, this review sheds light on evidence that such inclusion may have positive impacts on SCORAD index, stool quality, immunologic and inflammatory factors, and incidence of infection.

Human Milk Expression After Domperidone Treatment in Postpartum Women: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2018 ◽  
Vol 35 (3) ◽  
pp. 501-509 ◽  
Author(s):  
Alicia Taylor ◽  
Gabrielle Logan ◽  
Laurie Twells ◽  
Leigh Anne Newhook
Keyword(s):  
Human Milk ◽  
Randomized Controlled Trials ◽  
Milk Production ◽  
Meta Analysis ◽  
Random Effect ◽  
The United States ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Milk Volume ◽  
Insufficient Milk

Background: Insufficient milk production is among the most cited reasons by mothers for discontinuing breastfeeding. Medications that can increase milk production, such as domperidone, an off-label galactagogue, are often prescribed. Domperidone is controversial as it is not approved for any purpose in the United States and is approved only for gastrokinetic purposes in Canada and other countries. Research aim: The aim was to update the existing literature on the efficacy of domperidone as a galactagogue compared to placebo when given to mothers with insufficient human milk production. The primary outcome is the change in expressed human milk volume per day from baseline. Methods: The authors independently searched the literature from inception to May 2018. The search included any randomized controlled trials examining the efficacy of domperidone increasing mothers’ expressed human milk, measured via a human milk pump. Both authors independently assessed quality and risk of bias and extracted relevant data. Meta-analysis on expressed human milk volume per day was performed. Results: Seven studies met the inclusion criteria for review; two were excluded from the meta-analysis due to quality grading and insufficient reporting of the outcome of interest. Five studies ( N = 239) were combined in the meta-analysis. The effect size showed an increase in the mean difference of expressed human milk volume in mothers given domperidone, 93.97 mL per day (95% CI [71.12, 116.83 mL]; random effect, T2 0.00, I2 0%). Conclusion: This meta-analysis reports a significant improvement in expressed human milk volume per day with the use of domperidone in mothers experiencing insufficient human milk production.

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