Dataset Information

Systematic review of outcome domains and measures used in psychosocial and pharmacological treatment trials for cannabis use disorder.

ABSTRACT: Cannabis use disorder (CUD) is prevalent and demand for treatment is increasing, yet few individuals engage in formal treatment and the efficacy of established interventions for CUD is modest. Existing clinical trials evaluating psychosocial and pharmacological treatments for CUD have incorporated a wide variety of measures for assessing cannabis use outcomes, including abstinence, self-reported frequency and quantity used, withdrawal, use/dependence severity, and other psychosocial outcomes. The heterogeneity of measures and outcomes has limited quantitative analyses of the comparative effectiveness of existing interventions. The purpose of this systematic review is to: 1) identify and characterize approaches for measuring cannabis use in existing CUD intervention trials, including abstinence, frequency and quantity of use, and 2) summarize measures used to assess treatment efficacy in other outcome domains (e.g., cannabis use severity, psychosocial functioning, cannabis withdrawal), and provide a platform for future research to evaluate which outcome measures are most likely to reflect treatment efficacy and clinically significant improvement in other outcome domains.

SUBMITTER: Lee DC

PROVIDER: S-EPMC7038155 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Systematic review of outcome domains and measures used in psychosocial and pharmacological treatment trials for cannabis use disorder.

Lee Dustin C DC Schlienz Nicolas J NJ Peters Erica N EN Dworkin Robert H RH Turk Dennis C DC Strain Eric C EC Vandrey Ryan R

Drug and alcohol dependence 20181115

Cannabis use disorder (CUD) is prevalent and demand for treatment is increasing, yet few individuals engage in formal treatment and the efficacy of established interventions for CUD is modest. Existing clinical trials evaluating psychosocial and pharmacological treatments for CUD have incorporated a wide variety of measures for assessing cannabis use outcomes, including abstinence, self-reported frequency and quantity used, withdrawal, use/dependence severity, and other psychosocial outcomes. Th ...[more]

PMID: 30530238

Similar Datasets

Project description:BackgroundAnkle fractures cause considerable pain, loss of function and healthcare resource use. High quality randomised controlled trials are required to evaluate the optimal management protocols for ankle fracture. However, there is debate regarding the most appropriate outcome measure to use when assessing patients with ankle fractures. The aim of this systematic review is to identify and summarise primary outcome measure use in clinical trials of non-pharmacological interventions for adults with an ankle fracture.MethodsWe performed comprehensive searches of the Medline, Embase, CINAHL, AMED and Cochrane CENTRAL databases, as well as ISRCTN and ClinicalTrials.gov online clinical trial registries on 19/06/2019 with no date limits applied. The titles and abstracts were initially screened to identify randomised or quasi-randomised clinical trials of non-pharmacological interventions for ankle fracture in adults. Two authors independently screened the full text of any articles which could potentially be eligible. Descriptive statistics we used to summarise the outcome measures collected in these articles including an assessment of trends over time. Secondary analysis included a descriptive summary of the multi-item patient reported outcome measures used in this study type.ResultsThe searches returned a total of 3380 records. Following application of the eligibility criteria, 121 records were eligible for inclusion in this review. The most frequently collected primary outcome measures in this type of publication was the Olerud Molander Ankle Score, followed by radiographic and range of movement assessments. There was a total of 28 different outcome measures collected and five different multi-item, patient reported outcome measures collected as the primary outcome measure. There was a sequential increase in the number of this type of study published per decade since the 1980's.ConclusionThis review demonstrates the wide range of measurement methods used to assess outcome in adults with an ankle fracture. Future research should focus on establishing the validity and reliability of the outcome measures used in this patient population. Formulation of a consensus based core outcome set for adults with an ankle fracture would be advantageous for ensuring homogeneity across studies in order to meta-analyse trial results.

Project description:BackgroundMultiple Sclerosis (MS) is associated with impaired gait and a growing number of clinical trials have investigated efficacy of various interventions. Choice of outcome measures is crucial in determining efficiency of interventions. However, it remains unclear whether there is consensus on which outcome measures to use in gait intervention studies in MS.ObjectiveWe aimed to identify the commonly selected outcome measures in randomized controlled trials (RCTs) on gait rehabilitation interventions in people with MS. Additional aims were to identify which of the domains of the International Classification of Functioning, Disability and Health (ICF) are the most studied and to characterize how outcome measures are combined and adapted to MS severity.MethodsPubmed, Cochrane Central, Embase and Scopus databases were searched for RCT studies on gait interventions in people living with MS according to PRISMA guidelines.ResultsIn 46 RCTs, we identified 69 different outcome measures. The most used outcome measures were 6-minute walking test and the Timed Up and Go test, used in 37% of the analyzed studies. They were followed by gait spatiotemporal parameters (35%) most often used to inform on gait speed, cadence, and step length. Fatigue was measured in 39% of studies. Participation was assessed in 50% of studies, albeit with a wide variety of scales. Only 39% of studies included measures covering all ICF levels, and Participation measures were rarely combined with gait spatiotemporal parameters (only two studies).ConclusionsSelection of outcome measures remains heterogenous in RCTs on gait rehabilitation interventions in MS. However, there is a growing consensus on the need for quantitative gait spatiotemporal parameter measures combined with clinical assessments of gait, balance, and mobility in RCTs on gait interventions in MS. Future RCTs should incorporate measures of fatigue and measures from Participation domain of ICF to provide comprehensive evaluation of trial efficacy across all levels of functioning.

Project description:There is no evidence-based guidance to facilitate design decisions for confirmatory trials or systematic reviews investigating treatment efficacy for adults with tinnitus. This systematic review therefore seeks to ascertain the current status of trial designs by identifying and evaluating the reporting of outcome domains and instruments in the treatment of adults with tinnitus.Records were identified by searching PubMed, EMBASE CINAHL, EBSCO, and CENTRAL clinical trial registries (ClinicalTrials.gov, ISRCTN, ICTRP) and the Cochrane Database of Systematic Reviews. Eligible records were those published from 1 July 2006 to 12 March 2015. Included studies were those reporting adults aged 18 years or older who reported tinnitus as a primary complaint, and who were enrolled into a randomised controlled trial, a before and after study, a non-randomised controlled trial, a case-controlled study or a cohort study, and written in English. Studies with fewer than 20 participants were excluded.Two hundred and twenty-eight studies were included. Thirty-five different primary outcome domains were identified spanning seven categories (tinnitus percept, impact of tinnitus, co-occurring complaints, quality of life, body structures and function, treatment-related outcomes and unclear or not specified). Over half the studies (55 %) did not clearly define the complaint of interest. Tinnitus loudness was the domain most often reported (14 %), followed by tinnitus distress (7 %). Seventy-eight different primary outcome instruments were identified. Instruments assessing multiple attributes of the impact of tinnitus were most common (34 %). Overall, 24 different patient-reported tools were used, predominantly the Tinnitus Handicap Inventory (15 %). Loudness was measured in diverse ways including a numerical rating scale (8 %), loudness matching (4 %), minimum masking level (1 %) and loudness discomfort level (1 %). Ten percent of studies did not clearly report the instrument used.Our findings indicate poor appreciation of the basic principles of good trial design, particularly the importance of specifying what aspect of therapeutic benefit is the main outcome. No single outcome was reported in all studies and there was a broad diversity of outcome instruments.The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): CRD42015017525 . Registered on 12 March 2015 revised on 15 March 2016.

Dataset Information

Systematic review of outcome domains and measures used in psychosocial and pharmacological treatment trials for cannabis use disorder.

Publications

Systematic review of outcome domains and measures used in psychosocial and pharmacological treatment trials for cannabis use disorder.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets