Pharmacotherapeutic Trials in Tardive Dyskinesia

1979 ◽  
Vol 135 (6) ◽  
pp. 489-499 ◽  
Author(s):  
Angus V. P. Mackay ◽  
Graham P. Sheppard
Keyword(s):  
Tardive Dyskinesia ◽  
Trial Design ◽  
Rating Scales ◽  
Controlled Trials ◽  
Clinical Prediction ◽  
Clinical Factors ◽  
Pharmacological Agents ◽  
Therapeutic Value ◽  
Drug Challenge ◽  
Definition Of

SummarySome of the clinical factors contributing to the currently unsatisfactory state of therapy for tardive dyskinesia are reviewed. Problems such as lack of clear syndrome delineation and phenomenological description, the lack of standardization in rating scales and the lack of attention to trial design have all probably contributed to a rather confusing picture. Controlled trials suggest that several pharmacological agents may be of therapeutic value but that clinical prediction of an individual's response is impossible. The strategy of acute drug challenge has emerged as perhaps the most promising approach to the definition of pharmacological subtypes and therefore the choice of optimal treatment.

scholarly journals Designing provider-focused implementation trials with purpose and intent: introducing the PRECIS-2-PS tool

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Wynne E. Norton ◽  
Kirsty Loudon ◽  
David A. Chambers ◽  
Merrick Zwarenstein
Keyword(s):  
Trial Design ◽  
Primary Outcome ◽  
Controlled Trials ◽  
Primary Analysis ◽  
Research And Practice ◽  
Main Text ◽  
Randomized Controlled ◽  
Intervention Trials ◽  
Implementation Resources ◽  
The Continuum

Abstract Background First articulated by Schwartz and Lellouch (1967), randomized controlled trials (RCTs) can be conceptualized along a continuum from more explanatory to more pragmatic. The purpose and intent of the former is to test interventions under ideal contexts, and the purpose and intent of the latter is to test interventions in real-world contexts. The PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) is a validated tool that helps researchers make decisions about the elements of the trial to match the overall purpose and intent of the trial along the continuum. The PRECIS-2 tool has guided the design of hundreds of RCTs. However, a few aspects of the tool would benefit from greater clarity, including its application to provider-focused implementation trials rather than patient-focused intervention trials. Main text We describe the newly developed PRECIS-2-Provider Strategies (PRECIS-2-PS) tool, an extension of the PRECIS-2 tool, which has been adapted for trials testing provider-focused strategies. We elaborate on nine domains that can make a provider-focused trial more explanatory or more pragmatic, including eligibility, recruitment, setting, implementation resources, flexibility of provider strategies, flexibility of intervention, data collection, primary outcome, and primary analysis. We detail the complementary roles that researchers and stakeholders play in the trial design phase, with implications for generalizability of trial results to the contexts in which they are intended to be applied. Conclusions The PRECIS-2-PS tool is designed to help research and practice teams plan for provider-focused trials that reflect the overall intent and purpose of the trial. The tool has potential to help advance the science of provider-focused strategies across a range of trials, with the ultimate goal of facilitating the adoption, integration, and sustainability of provider-focused strategies outside the context of trials.

Antipsychotic drugs v. barbiturates or benzodiazepines used as active placebos for schizophrenia: a systematic review and meta-analysis

2019 ◽  
Vol 50 (15) ◽  
pp. 2622-2633 ◽  
Author(s):  
Spyridon Siafis ◽  
Giacomo Deste ◽  
Anna Ceraso ◽  
Christian Mussoni ◽  
Antonio Vita ◽  
...  
Keyword(s):  
Antipsychotic Drugs ◽  
Rating Scales ◽  
Meta Analysis ◽  
Chronically Ill ◽  
Response To Treatment ◽  
Controlled Trials ◽  
Large Sample Size ◽  
Mean Values ◽  
Random Effects Models ◽  
Acute Schizophrenia

AbstractBackgroundComparisons of antipsychotics with placebo can be biased by unblinding due to side effects. Therefore, this meta-analysis compared the efficacy of antipsychotics for acute schizophrenia in trials using barbiturates or benzodiazepines as active placebos.MethodsRandomized controlled trials (RCTs) in acute schizophrenia with at least 3 weeks duration and comparing any antipsychotic with barbiturates or benzodiazepines were eligible. ClinicalTrials.gov, CENTRAL, EMBASE, MEDLINE, PsycINFO, PubMed, WHO-ICTRP as well as previous reviews were searched up to 9 January 2018. Two separate meta-analyses, one for barbiturates and one for benzodiazepines, were conducted using random-effects models. The primary outcome was response to treatment, and mean values of schizophrenia rating scales and dropouts were analyzed as secondary outcomes. This study is registered with PROSPERO (CRD42018086263).ResultsSeven barbiturate-RCTs (number of participants n = 1736), and two benzodiazepine-RCTs (n = 76) were included in the analysis. The studies were published between 1960 and 1968 and involved mainly chronically ill patients. More patients on antipsychotics in comparison to barbiturates achieved a ‘good’ response (36.2% v. 16.8%; RR 2.15; 95% CI 1.36–3.41; I2 = 48.9) and ‘any’ response (57.4% v. 27.8%; RR 2.07; 95% CI 1.35–3.18; I2 = 68.2). In a single small trial (n = 60), there was no difference between antipsychotics and benzodiazepines on ‘any’ response (74.7% v. 65%; RR 1.15; 95% CI 0.82–1.62).ConclusionsAntipsychotic drugs were more efficacious than barbiturates, based on a large sample size. Response ratios were similar to those observed in placebo-controlled trials. The results on benzodiazepines were inconclusive due to the small number of studies and participants.

RANDOMISED CONTROLLED TRIALS OF CHRONIC PAIN IN CHILDREN AND ADOLESCENTS: A SYSTEMATIC REVIEW

2015 ◽  
Vol 101 (1) ◽  
pp. e1.66-e1
Author(s):  
Rym Boulkedid ◽  
Armiya Yousouf Abdou ◽  
Emilie Desselas ◽  
Marlène Monegat ◽  
Corinne Alberti ◽  
...  
Keyword(s):  
Systematic Review ◽  
Chronic Pain ◽  
Randomized Controlled Trials ◽  
Children And Adolescents ◽  
Methodological Quality ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Recurrent Pain ◽  
Pharmacological Agents ◽  
Randomized Controlled

BackgroundApproximately 15 to 30% of children and adolescents suffer from daily pain persistent over more than 3 months and there is evidence supporting that the prevalence of chronic pain is steadily increasing in this population. Chronic pain is known to have a negative impact on children's development and social behaviour, leading often to severe psychological distress and physical disability. We reviewed medical literature to assess the characteristics and quality of randomized controlled trials (RCTs) on pharmacological and non-pharmacological therapies in chronic and recurrent pain in the paediatric population.MethodsWe performed a systematic search of PubMed, Embase and the Cochrane Library up to March 2014. Bibliographies of relevant articles were also hand-searched. We included all RCTs that involved children and adolescents (age 0 to 18 years) and evaluated the use of a pharmacological agent or a non-pharmacological approach in the context of chronic or recurrent pain. The latter was defined as pain persisting for more than 3 months. Methodological quality was evaluated using the Cochrane Risk of Bias Tool. Two reviewers independently assessed studies for inclusion and evaluated methodological quality.ResultsA total of 52 randomized controlled trials were selected and included in the analysis. The majority were conducted in single hospital institutions, with no information on study funding. Median sample size was 45 (34–57) participants. Almost 50% of the RCTs included both adults and children with a median age at inclusion of 13 years. Non-pharmacological approaches were more commonly tested whereas evaluation of pharmacological agents concerned less than 30% of RCTs. Abdominal pain and headache were the most common types of chronic pain experienced among trial participants. Overall, the methodological quality was poor and did not parallel the number of RCTs that increased over the years. The risk of bias was high or unclear in 70% of the trials.ConclusionsThis is the first systematic review of RCTs conducted to evaluate pharmacological and non-pharmacological therapies in chronic and recurrent pain in children and adolescents. Although, management of pain in adults has significantly improved over the years due to the evaluation of numerous analgesic therapies, our results highlight the existing knowledge gap with regards to children and adolescents. Therapeutic strategies, in particular pharmacological agents, applied to relieve chronic or recurrent pain in children and adolescents are not evaluated through high quality RCTs. The need to improve analgesic therapy in children and adolescents with chronic pain is still unmet. We discuss possible research constraints and challenges related to this fact as well as adequate methodologies to circumvent them.

scholarly journals Clínica quirúrgica de los cuerpos extraños en el abdomen: Oblito quirúrgico abdominal.

2013 ◽  
Vol 9 (2) ◽  
pp. 77
Author(s):  
Edgar NUÑEZ HUERTA
Keyword(s):  
Point Of View ◽  
Legal Principles ◽  
Clinical Forms ◽  
Therapeutic Value ◽  
Definition Of ◽  
Cuerpos Extraños

Philosophic medical and legal principles are stated introducing the name oblito, explaining its linguistic root.the definition of foreing body accidentally forgotten during an operation and with no therapeutic value, is proposed. The characteristics of the foreing body left in the abdomen during surgery from the nosographic and nosologic point of view, give this process an individuality, that allows to speak about its clinics. The symptomatology is clear and connected to the clinical forms analyzed.diagnosis is reached specially by radiology. In orden to complete the oblito's pathological similitude with other abdominal processes, it is necessary to point out that it has a regulated prophilaxis, in nearly every surgical center.

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 US rheumatologists’ beliefs and knowledge about biosimilars: a survey

Rheumatology ◽  
2020 ◽  
Author(s):  
Allan Gibofsky ◽  
Dorothy McCabe
Keyword(s):  
Online Survey ◽  
Rating Scales ◽  
Reference Product ◽  
Plain Language ◽  
Biologic Treatment ◽  
Naive Patient ◽  
Tnf Α ◽  
Treatment Naïve ◽  
Definition Of ◽  
Additional Education

Abstract Objectives We sought to evaluate perceptions of biosimilar products among US rheumatologists who prescribe TNF-α inhibitors, given that 10 TNF-α inhibitor biosimilars and two rituximab biosimilars have Food and Drug Administration (FDA) approval. Methods A 19-question self-administered online survey was conducted from 6 May to 1 June 2019, and fielded by WebMD, LLC. Rheumatologists (n = 9050) who were members of Medscape.com and its partner panels were invited to participate. Likert and other rating scales were used to collect responses, which were summarized descriptively. Results Responses were obtained from 320 board-certified US rheumatologists, 85% of whom were fellows of the ACR. Nearly all respondents were familiar with the FDA definition of a biosimilar product and were aware that an infliximab biosimilar was FDA approved; fewer realized that adalimumab, etanercept and rituximab biosimilars were also FDA approved. Most respondents (84%) were aware that an approved biosimilar was not automatically deemed interchangeable by the FDA. Rheumatologists were more likely to initiate biosimilar treatment for a biologic treatment-naïve patient with RA (73%) than they were to switch to the biosimilar for a patient with RA doing well on the reference product (35%). Conclusions The results of this survey suggest that US rheumatologists have a good understanding and acceptance of biosimilar products, particularly for the initiation of treatment in biologic-naïve individuals. They were hesitant to switch from a reference product to a biosimilar for a patient doing well on the reference product. Additional education on biosimilars is required to help inform treatment decisions by rheumatologists. A plain language summary of this article has been uploaded as supplementary material, available at Rheumatology online.

Recommendations for improving clinical trial design to facilitate the study of youth-onset type 2 diabetes

2019 ◽  
Vol 17 (1) ◽  
pp. 87-98
Author(s):  
Muhammad Yazid Jalaludin ◽  
Margarita Barrientos-Pérez ◽  
Mona Hafez ◽  
Jane Lynch ◽  
Naim Shehadeh ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trials ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Control Group ◽  
Onset Type ◽  
Therapeutic Choice ◽  
Glycemic Targets ◽  
Definition Of

Background The prevalence of type 2 diabetes is increasing in youths and differs from adult-onset type 2 diabetes in its characteristics and progression. Currently, only two drugs are approved for youth-onset type 2 diabetes and many patients are not meeting glycemic targets. Clearly, there is an urgent need to complete clinical trials in youths with type 2 diabetes to increase the therapeutic choice for these patients. However, factors such as limited patient numbers, unwillingness of patients to participate in trials, failure to meet strict inclusion and exclusion criteria, and poor clinic attendance have limited the size and number of trials in this complicated patient demographic. Recommendations This is a narrative opinion piece on the design of clinical trials in youth-onset type 2 diabetes prepared by researchers who undertake this type of study in different countries. The review addresses possible ways to enhance trial designs in youth-onset type 2 diabetes to meet regulatory requirements, while minimizing the barriers to patients’ participation. The definition of adolescence, recruitment of sufficient patient numbers, increasing flexibility in selection criteria, improving convenience of trial visits, requirements of a control group, possible endpoints, and trial compliance are all considered. The authors recommend allowing extrapolation from adult data, using multiple interventional arms within future trials, broadening inclusion criteria, and focusing on endpoints beyond glucose control, among others, in order to improve the successful completion of more trials in this population. Conclusions Improvements in trial design will enable better recruitment and retention and thereby more evidence for treatment outcomes for youth-onset type 2 diabetes.

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