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, researchers must conduct clinical trials designed 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.
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.
Practical clinical trials, which are intended to provide generalizable answers to important clinical questions without bias, are characterized by eight key features: a straightforward clinically relevant question, a representative sample of patients and practice settings, sufficient power to identify modest clinically relevant effects, randomization to protect against bias, clinical uncertainty regarding the outcome of treatment at the patient level, assessment and treatment protocols that enact best clinical practices, simple and clinically relevant outcomes, and limited subject and investigator burden.
To implement the practical clinical trials model in psychiatry will require stable funding for network construction and maintenance plus methodological innovation in governance and trial selection, assessment, treatment, data management, site management, and data analytic procedures.
"One of the most pressing concerns in healthcare today is the slow rate at which promising clinical interventions, supported by research evidence, move into clinical practice [1-6]. While effectiveness trials are a step in the research pipeline designed to determine whether promising clinical interventions work when tested in “real world” settings, the results of such trials generally do not provide clinicians, administrators, or quality improvement specialists with the information that they will need to successfully implement the new practice in their clinic or hospital [7-10]. This is the role of implementation trials which attempt to develop successful strategies for implementing new, effective practices, which then can be disseminated/spread to other clinical settings [8,11]. "
[Show abstract][Hide abstract] ABSTRACT: Background
One of the pressing concerns in health care today is the slow rate at which promising interventions, supported by research evidence, move into clinical practice. One potential way to speed this process is to conduct hybrid studies that simultaneously combine the collection of effectiveness and implementation relevant data. This paper presents implementation relevant data collected during a randomized effectiveness trial of an abstinence incentive intervention conducted in substance use disorders treatment clinics at two Veterans Health Administration (VHA) medical centers.
Participants included patients entering substance use disorders treatment with diagnoses of alcohol dependence and/or stimulant dependence that enrolled in the randomized trial, were assigned to the intervention arm, and completed a post intervention survey (n = 147). All staff and leadership from the participating clinics were eligible to participate. A descriptive process evaluation was used, focused on participant perceptions and contextual/feasibility issues. Data collection was guided by the RE-AIM and PARIHS implementation frameworks. Data collection methods included chart review, intervention cost tracking, patient and staff surveys, and qualitative interviews with staff and administrators.
Results indicated that patients, staff and administrators held generally positive attitudes toward the incentive intervention. However, staff and administrators identified substantial barriers to routine implementation. Despite the documented low cost and modest staff time required for implementation of the intervention, securing funding for the incentives and freeing up any staff time for intervention administration were identified as primary barriers.
Recommendations to facilitate implementation are presented. Recommendations include: 1) solicit explicit support from the highest levels of the organization through, for example, performance measures or clinical practice guideline recommendations; 2) adopt the intervention incrementally starting within a specific treatment track or clinic to reduce staff and funding burden until local evidence of effectiveness and feasibility is available to support spread; and 3) educate staff about the process, goals, and value/effectiveness of the intervention and engage them in implementation planning from the start to enhance investment in the intervention.
Addiction science & clinical practice 07/2014; 9(1):12. DOI:10.1186/1940-0640-9-12
"Finally, the few studies that report tolerability data [Adams et al. 2001; Marchiaro et al. 2005; Haro et al. 2006] did not use direct measures (i.e. rating scales) but clinical observations regarding anticholinergic use. "
[Show abstract][Hide abstract] ABSTRACT: Despite their widespread use, long acting injectable (LAI) antipsychotics (APs), are often regarded with some negativity because of the assumption of punishment, control and insufficient evolution towards psychosocial development of patients. However, LAI APs have proved effective in schizophrenia and other severe psychotic disorders because they assure stable blood levels, leading to a reduction of the risk of relapse. Therapeutic opportunities have also arisen after introduction of newer, second-generation LAI APs in recent years. Newer LAI APs are more readily dosed optimally, may be better tolerated and are better suited to integrated rehabilitation programmes.
This review outlines the older and newer LAI APs available for the treatment of schizophrenia, with considerations of past and present pharmacological and therapeutic issues. Traditional, evidence-based approaches to systematic reviews and randomized clinical trials are of limited utility in this area so this paper’s blending of experimental trials with observational research is particularly appropriate and effective.
Therapeutic Advances in Psychopharmacology 07/2014; DOI:10.1177/2045125314540297 · 1.53 Impact Factor
"The proposed study utilizes a hybrid efficacy/effectiveness design . This type of trial focuses on the evaluation of the benefit of a treatment when applied in a community service setting under research sampling and assessment conditions. "
[Show abstract][Hide abstract] ABSTRACT: Background
This article provides a description of the rationale, design, and methods of a multisite clinical trial which evaluates the potential benefits of an evidence-based psychosocial treatment, STAIR Narrative Therapy, among women with posttraumatic stress disorder (PTSD) related to interpersonal violence who are seeking services in public sector community mental health clinics. This is the first large multisite trial of an evidence-based treatment for PTSD provided in the context of community settings that are dedicated to the treatment of poverty-level patient populations.
The study is enrolling 352 participants in a minimum of 4 community clinics. Participants are randomized into either STAIR Narrative Therapy or Treatment As Usual (TAU). Primary outcomes are PTSD, emotion management and interpersonal problems. The study will allow a flexible application of the protocol determined by patient need and preferences. Secondary analyses will assess the relationship of outcomes to different patterns of treatment implementation for different levels of baseline symptom severity.
The article discusses the rationale and study issues related to the use of a flexible delivery of a protocol treatment and of the selection of treatment as it is actually practiced in the community as the comparator.
Clinicaltrials.gov identifier: NCT01488539.
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