Psychometric Properties of Child (0-5 Years) Outcome Measures as used in Randomized Controlled Trials of Parent Programs: A Systematic Review.
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ABSTRACT:
SUBMITTER: Gridley N
PROVIDER: S-EPMC6669186 | biostudies-literature | 2019 Sep
REPOSITORIES: biostudies-literature
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Project description:This systematic review sought to identify observational measures of parent-child interactions commonly implemented in parenting program research, and to assess the level of psychometric evidence available for their use with this age group. Two separate searches of the same databases were conducted; firstly, to identify eligible instruments, and secondly to identify studies reporting on the psychometric properties of the identified measures. Five commercial platforms hosting 19 electronic databases were searched from their inception to conducted search dates. Fourteen measures were identified from Search 1; a systematic search of randomized controlled trial evaluations of parenting programs. For Search 2, inclusion/exclusion criteria were applied to 1327 retrieved papers that described the development and/or validation of the 14 measures identified in Search 1. Seventeen articles met the inclusion criteria, resulting in five observational measures for the final review. Data were extracted and synthesized using the COSMIN rating system to describe the methodological quality of each article alongside the overall quality rating of the psychometric property reported for each measure using the Terwee checklist. Measure reliability was categorized into four domains (internal consistency, test-re-test, inter-rater, and intra-rater). Measure validity was categorized into four domains (content, structural, convergent/divergent, and discriminant). Results indicated that the majority of psychometric evidence related to children aged from birth the three with internal consistency, inter-rater reliability, and structural validity the most commonly reported properties, although this evidence was often weak. The findings suggest further validation of the included measures is required to establish acceptability for the whole target age group.
| S-EPMC6478772 | biostudies-literature
Project description:Parenting programs are effective in the early intervention and treatment of children's social, emotional and behavioural difficulties. However, inconsistency in the use of outcome measures limits the comparability of programs and creates challenges for practitioners seeking to monitor progress of families in their care. A systematic review was conducted to identify measures, appraise their psychometric properties and ease of implementation, with the overall objective of recommending a small battery of measures for use by researchers and practitioners. This article provides an overview of the most commonly used measures in experimental evaluations of parenting programs delivered to parents of children up to, and including, the age of 5 years (including antenatal programs). An in-depth appraisal of the psychometric properties and ease of implementation of parent outcome measures is also presented (findings in relation to child and dyadic outcome measures are presented elsewhere). Following a systematic search, 64 measures were identified as being used in three or more of 279 included evaluation studies. Data on the psychometric properties of 18 parent outcome measures were synthesised from 87 development and validation studies. Whilst it was not possible to identify a definitive battery of recommended measures, we are able to recommend specific measures that could be prioritised in further research and development and hold promise for those seeking to monitor the outcomes of parents and children in receipt of parenting programs.
| S-EPMC6669247 | biostudies-literature
Project description:Parent-child communication represents an important variable in clinical child and family psychology due to its association with a variety of psychosocial outcomes. To give an overview of instruments designed to measure the quality of parent-child communication from the child's (8-21 years) perspective and to assess the psychometric quality of these instruments, we performed a systematic literature search in Medline and PsycInfo (last: February 25, 2022). Peer-reviewed journal articles published in English with a child-rated instrument measuring the quality of parent-child communication were included. Initial screening for eligibility and inclusion, subsequent data extraction, and quality assessment were conducted by couples of review team members. Based on the screening of 5115 articles, 106 studies reported in 126 papers were included. We identified 12 parent-child communication instruments across the studies. The Parent-Adolescent Communication Scale (PACS) was used in 75% of the studies. On average, the evidence for psychometric quality of the instruments was low. Few instruments were used in clinical and at-risk samples. Several instruments are available to rate parent-child communication from the child's perspective. However, their psychometric evidence is limited and the theoretical foundation is largely undocumented. This review has limitations with regard to selection criteria and language bias.Registration PROSPERO: CRD42021255264.
| S-EPMC9879831 | biostudies-literature
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.
| S-EPMC6712770 | biostudies-literature
Project description:BackgroundThe development and application of standardised sets of outcomes to be measured and reported in clinical trials have the potential to increase the efficiency and value of research. One of the most notable of the current outcome sets began nearly 20 years ago: the World Health Organization and International League of Associations for Rheumatology core set of outcomes for rheumatoid arthritis clinical trials, originating from the OMERACT (Outcome Measures in Rheumatology) Initiative. This study assesses the use of this core outcome set by randomised trials in rheumatology.MethodsAn observational review was carried out of 350 randomised trials for the treatment of rheumatoid arthritis identified through The Cochrane Library (up to and including September 2012 issue). Reports of these trials were evaluated to determine whether or not there were trends in the proportion of trials reporting on the full set of core outcomes over time. Researchers who conducted trials after the publication of the core set were contacted to assess their awareness of it and to collect reasons for non-inclusion of the full core set of outcomes in the study.ResultsSince the introduction of the core set of outcomes for rheumatoid arthritis, the consistency of measurement of the core set of outcomes has improved, although variation in the choice of measurement instrument remains. The majority of trialists who responded said that they would consider using the core outcome set in the design of a new trial.ConclusionsThis observational review suggests that a higher percentage of trialists conducting trials in rheumatoid arthritis are now measuring the rheumatoid arthritis core outcome set. Core outcome sets have the potential to improve the evidence base for health care, but consideration must be given to the methods for disseminating their availability amongst the relevant communities.
| S-EPMC3852710 | biostudies-literature
Project description:Multiple gene therapy trials are occurring for a variety of ophthalmic diseases around the world. The safety of gene therapy in the eye has been established, and the next step is to reliably assess efficacy. This is primarily done through the use of imaging techniques and visual function measures. Standardized visual function assessments, however, were originally developed for a clinical setting and may not be suitable for detecting and quantifying therapeutic changes. This scoping review takes a comprehensive look at current practice in terms of the outcome measures defined at trial registration. These were compared to the outcome measures reported in the literature. All published trials reported the pre-registered primary outcome measure. A range of additional secondary outcomes were reported that were not originally planned. Gaps in gene therapy assessment exist and further discussion are required to find a way forward, particularly as more conditions progress to phase 2 and 3 trials. Several factors impacting on trial design and outcome measure choice are discussed.
| S-EPMC6759794 | biostudies-literature
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.
| S-EPMC8483298 | biostudies-literature
Project description:Implementation outcome measures are essential for monitoring and evaluating the success of implementation efforts. Yet, currently available measures lack conceptual clarity and have largely unknown reliability and validity. This study developed and psychometrically assessed three new measures: the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM).Thirty-six implementation scientists and 27 mental health professionals assigned 31 items to the constructs and rated their confidence in their assignments. The Wilcoxon one-sample signed rank test was used to assess substantive and discriminant content validity. Exploratory and confirmatory factor analysis (EFA and CFA) and Cronbach alphas were used to assess the validity of the conceptual model. Three hundred twenty-six mental health counselors read one of six randomly assigned vignettes depicting a therapist contemplating adopting an evidence-based practice (EBP). Participants used 15 items to rate the therapist's perceptions of the acceptability, appropriateness, and feasibility of adopting the EBP. CFA and Cronbach alphas were used to refine the scales, assess structural validity, and assess reliability. Analysis of variance (ANOVA) was used to assess known-groups validity. Finally, half of the counselors were randomly assigned to receive the same vignette and the other half the opposite vignette; and all were asked to re-rate acceptability, appropriateness, and feasibility. Pearson correlation coefficients were used to assess test-retest reliability and linear regression to assess sensitivity to change.All but five items exhibited substantive and discriminant content validity. A trimmed CFA with five items per construct exhibited acceptable model fit (CFI = 0.98, RMSEA = 0.08) and high factor loadings (0.79 to 0.94). The alphas for 5-item scales were between 0.87 and 0.89. Scale refinement based on measure-specific CFAs and Cronbach alphas using vignette data produced 4-item scales (?'s from 0.85 to 0.91). A three-factor CFA exhibited acceptable fit (CFI = 0.96, RMSEA = 0.08) and high factor loadings (0.75 to 0.89), indicating structural validity. ANOVA showed significant main effects, indicating known-groups validity. Test-retest reliability coefficients ranged from 0.73 to 0.88. Regression analysis indicated each measure was sensitive to change in both directions.The AIM, IAM, and FIM demonstrate promising psychometric properties. Predictive validity assessment is planned.
| S-EPMC5576104 | biostudies-literature
Project description:ObjectivesTo assess the discriminatory capacity of various outcome measures and response criteria in patients with peripheral spondyloarthritis (pSpA).MethodsData originated from two randomised controlled trials, ABILITY-2 and Tnf Inhibition in PEripheral SpondyloArthritis (TIPES). Continuous outcome measures included patient's global assessment (PGA)/physician's global assessment of disease (PhGA), C-reactive protein (CRP), tender joint counts (TJC)/swollen joint counts (SJC), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Ankylosing Spondylitis Disease Activity Score (ASDAS). Dichotomous response criteria included Peripheral SpondyloArthritis Response Criteria (PSpARC), American College of Rheumatology (ACR), ASDAS and BASDAI response criteria. The capacity to discriminate between adalimumab and placebo groups was assessed by standardised mean differences (SMD) for continuous variables, and Pearson's χ(2) for dichotomous response criteria.ResultsWithin each trial, the composite indices for axial SpA assessment, ASDAS-CRP (SMD: -0.63 and -0.89 in ABILITY-2 and the TIPES trial, respectively) and BASDAI (SMD: -0.50 and -0.73), and the single-item measures PGA (SMD: -0.47 and -1.12) and PhGA (SMD: -0.64 and -0.87) performed better than other single-item measures, such as CRP (SMD: -0.18 and -0.53), SJC or TJC. In general, the PSpARC and ACR response criteria discriminated better than ASDAS and BASDAI response criteria.ConclusionsThe axial SpA-specific ASDAS-CRP and BASDAI, but also PGA and PhGA, demonstrated good discriminatory ability in patients with pSpA. The pSpA-specific pSpARC response criteria and the rheumatoid arthritis-specific ACR response criteria also discriminated well. To fully capture typical pSpA manifestations, it may be worth developing new pSpA-specific indices with better performance and face validity.Trial registration numbersABILITY-2: NCT01064856; TIPES: EUDRACT 2008-006885-27.
| S-EPMC4941177 | biostudies-literature
Project description:IntroductionAssessing treatment response is key to determining treatment value in atopic dermatitis (AD). Currently, response is assessed using various clinician- or patient-reported measures and response criteria. This variation creates a mismatch of evidence across trials, hindering the ability of clinicians, regulators, and payers to compare the efficacy of treatments. This review identifies which measures and criteria are used to determine response in clinical trials and health technology assessments (HTAs). Moreover, it systematically reviews the psychometric performance of those measures and criteria to understand which perform best in capturing patient-relevant symptoms and treatment benefits.MethodsA scoping review of clinical trials and HTAs in AD identified the following measures for inclusion: the Eczema Area and Severity Index (EASI), the Investigator's Global Assessment (IGA), the Dermatology Life Quality Index (DLQI) and the Peak Pruritus Numerical Rating Scale (PP-NRS). A systematic search was performed in MEDLINE and Embase to identify studies testing the psychometric performance of these measures in adults or adolescents with AD.ResultsA lack of consistency in the assessment of response was observed across clinical trials and HTAs. Important gaps in psychometric evidence were identified. No content validations of the EASI and IGA in AD were found, while some quantitative studies suggested that these measures fail to capture itch, a core symptom. The PP-NRS and DLQI performed well. No studies compared the performance of different response criteria.ConclusionContent validation of the PP-NRS confirmed the importance of itch as a core symptom and treatment priority in AD; however, itch is not well covered in the EASI or IGA. Including the PP-NRS in clinical trials and HTAs will better capture patient-relevant benefit and response. Although various response criteria were used, no studies compared the performance of different criteria to inform which were most appropriate to compare treatments in clinical trials and HTAs.
| S-EPMC10613159 | biostudies-literature