Effectiveness of the 'SELF-program' on nurses' activity encouragement behavior and nursing home resident's ADL self-reliance; a cluster-randomized trial.

Background: Nurses play a crucial role in encouraging nursing home resident's activity and independent functioning. However, nurses often take over tasks unnecessarily, which can deprive resident's remaining abilities. The Function-Focused Care philosophy offers guidance for developing programs that support nurses to optimize activity and independence of older people.

Young children's performance on a design fluency task: longitudinal data on total number of designs, clustering and switching, and regression-based norms.

Introduction: Design fluency (DF) tasks are commonly used to assess executive functions such as attentional control, cognitive flexibility, self-monitoring and strategy use. Next to the total number of correct designs, the standard outcome of a DF task, clustering and switching can help disentangle the processes underlying DF performance. We present the first longitudinal study of 4-8-year-old children's developmental DF trajectories.

Cluster Randomized Trials with a Pretest and Posttest: Equivalence of Three-, Two- and One-Level Analyses, and Sample Size Calculation.

In a cluster randomized trial clusters of persons, for instance, schools or health centers, are assigned to treatments, and all persons in the same cluster get the same treatment. Although less powerful than individual randomization, cluster randomization is a good alternative if individual randomization is impossible or leads to severe treatment contamination (carry-over). Focusing on cluster randomized trials with a pretest and post-test of a quantitative outcome, this paper shows the equivalence of four methods of analysis: a three-level mixed (multilevel) regression for repeated measures with as levels cluster, person, and time, and allowing for unstructured between-cluster and within-cluster covariance matrices; a two-level mixed regression with as levels cluster and person, using change from baseline as outcome; a two-level mixed regression with as levels cluster and time, using cluster means as data; a one-level analysis of cluster means of change from baseline.

Best (but oft forgotten) practices: Efficient sample sizes for commonly used trial designs.

Designing studies such that they have a high level of power to detect an effect or association of interest is an important tool to improve the quality and reproducibility of findings from such studies. Since resources (research subjects, time, and money) are scarce, it is important to obtain sufficient power with minimum use of such resources. For commonly used randomized trials of the treatment effect on a continuous outcome, designs are presented that minimize the number of subjects or the amount of research budget when aiming for a desired power level.

Pragmatic Uncontrolled Study of Specialized Cognitive Behavioral Therapy for Adults With Chronic Tinnitus.

Objectives: Tinnitus is the perception of sound without an external source, affecting quality of life that can cause severe distress in approximately 1 to 3% of the population of people with tinnitus. Randomized controlled trials of cognitive behavioral therapy for tinnitus have demonstrated its effectiveness in improving quality of life, but the effects of their implementation on a large scale in routine practice remains unknown. Therefore, the main purpose of this study was to examine the effects of stepped-care cognitive behavioral therapy for tinnitus delivered in a tertiary audiological center of a regional hospital.

Laparoscopic versus open resections in the posterosuperior liver segments within an enhanced recovery programme (ORANGE Segments): study protocol for a multicentre randomised controlled trial.

Background: A shift towards parenchymal-sparing liver resections in open and laparoscopic surgery emerged in the last few years. Laparoscopic liver resection is technically feasible and safe, and consensus guidelines acknowledge the laparoscopic approach in the posterosuperior segments. Lesions situated in these segments are considered the most challenging for the laparoscopic approach.

Imputation of Missing Covariates in Randomized Controlled Trials with Continuous Outcomes: Simple, Unbiased and Efficient Methods.

The literature on dealing with missing covariates in nonrandomized studies advocates the use of sophisticated methods like multiple imputation (MI) and maximum likelihood (ML)-based approaches over simple methods. However, these methods are not necessarily optimal in terms of bias and efficiency of treatment effect estimation in randomized studies, where the covariate of interest (treatment group) is independent of all baseline (pre-randomization) covariates due to randomization. This has been shown in the literature, but only for missingness on a single baseline covariate.

Sample size calculation and optimal design for regression-based norming of tests and questionnaires.

To prevent mistakes in psychological assessment, the precision of test norms is important. This can be achieved by drawing a large normative sample and using regression-based norming. Based on that norming method, a procedure for sample size planning to make inference on Z-scores and percentile rank scores is proposed.

Maximin design of cluster randomized trials with heterogeneous costs and variances.

Cluster randomized trials evaluate the effect of a treatment on persons nested within clusters, with clusters being randomly assigned to treatment. The optimal sample size at the cluster and person level depends on the study cost per cluster and per person, and the outcome variance at the cluster and the person level. The variances are unknown in the design stage and can differ between treatment arms.

A randomized controlled trial comparing community lifestyle interventions to improve adherence to diet and physical activity recommendations: the VitalUM study.

Worldwide, adherence to national guidelines for physical activity (PA), and fruit and vegetable consumption is recommended to promote health and reduce the risk for (chronic) disease. This study reports on the effectiveness of various social-cognitive interventions to improve adherence to guidelines and the revealed adherence predictors. Participants (n = 1,629), aged 45-70 years, randomly selected and recruited in 2005-2006 from 23 Dutch general practices, were randomized (centralized stratified allocation) to four groups to receive a 12-month lifestyle intervention targeting guideline adherence for PA and fruit and vegetable consumption.

The perceived behavior and barriers of community care professionals in encouraging functional activities of older adults: the development and validation of the MAINtAIN-C questionnaire.

Background: Community care professionals need to encourage older adults in performing functional activities to maintain independence. However, professionals often perform functional activities on behalf of older adults. To change this, insights into the behavior and barriers of professionals in encouraging activities are required.

Optimal two-stage sampling for mean estimation in multilevel populations when cluster size is informative.

To estimate the mean of a quantitative variable in a hierarchical population, it is logistically convenient to sample in two stages (two-stage sampling), i.e. selecting first clusters, and then individuals from the sampled clusters.

Imputation of missing covariate in randomized controlled trials with a continuous outcome: Scoping review and new results.

In this article, we first review the literature on dealing with missing values on a covariate in randomized studies and summarize what has been done and what is lacking to date. We then investigate the situation with a continuous outcome and a missing binary covariate in more details through simulations, comparing the performance of multiple imputation (MI) with various simple alternative methods. This is finally extended to the case of time-to-event outcome.

Aquatic Cycling Improves Knee Pain and Physical Functioning in Patients With Knee Osteoarthritis: A Randomized Controlled Trial.

Objective: To assess the efficacy of a 12-week aquatic cycling training program for improving knee pain and physical functioning in patients with knee osteoarthritis (OA).

Design: Two-arm, single-blind, parallel-group randomized controlled trial.

Settings: OA outpatient clinic of the Maastricht University Medical Center+.

An overview of mixture modelling for latent evolutions in longitudinal data: Modelling approaches, fit statistics and software.

The use of finite mixture modelling (FMM) is becoming increasingly popular for the analysis of longitudinal repeated measures data. FMMs assist in identifying latent classes following similar paths of temporal development. This paper aims to address the confusion experienced by practitioners new to these methods by introducing the various available techniques, which includes an overview of their interrelatedness and applicability.

Borderline personality disorder traits and affect reactivity to positive affect induction followed by a stressor.

Background And Objectives: Affective hyperreactivity is a core feature of Borderline Personality Disorder (BPD), yet little is known about reactivity of positive affect (PA). Objectives were to explore the relationship between BPD traits and affect reactivity in response to a personalized PA-induction and a subsequent stressor. Patient status (seeking outpatient treatment for personality-related problems; yes/no), depressive symptoms, and age were examined as alternative predictors of affect reactivity.

A Longitudinal Study on the Relations Among Fear-Enhancing Parenting, Cognitive Biases, and Anxiety Symptoms in Non-clinical Children.

This longitudinal study explored the relations between fear-enhancing parenting behaviors (modeling and threat information transmission) and children's cognitive biases and anxiety symptoms on three subsequent time points over a one-year period. Participants were 216 children aged 7-12 years (114 boys and 102 girls), and their mothers (n = 199) and/or fathers (n = 117). On each time point, children and parents completed the Parental Enhancement of Anxious Cognitions scale, which measures parental modeling and threat information transmission.

Relative efficiencies of two-stage sampling schemes for mean estimation in multilevel populations when cluster size is informative.

In multilevel populations, there are two types of population means of an outcome variable ie, the average of all individual outcomes ignoring cluster membership and the average of cluster-specific means. To estimate the first mean, individuals can be sampled directly with simple random sampling or with two-stage sampling (TSS), that is, sampling clusters first, and then individuals within the sampled clusters. When cluster size varies in the population, three TSS schemes can be considered, ie, sampling clusters with probability proportional to cluster size and then sampling the same number of individuals per cluster; sampling clusters with equal probability and then sampling the same percentage of individuals per cluster; and sampling clusters with equal probability and then sampling the same number of individuals per cluster.

Effects, costs and feasibility of the 'Stay Active at Home' Reablement training programme for home care professionals: study protocol of a cluster randomised controlled trial.

Background: According to the principles of Reablement, home care services are meant to be goal-oriented, holistic and person-centred taking into account the capabilities and opportunities of older adults. However, home care services traditionally focus on doing things for older adults rather than with them. To implement Reablement in practice, the 'Stay Active at Home' programme was developed.

SPEEK: effect evaluation of a Ghanaian school-based and peer-led sexual education programme.

In sub-Saharan Africa, theory and evidenced-based interventions that are systematically designed and using sound evaluation methods to report on effectiveness are limited. A sex education programme called SPEEK was developed, implemented and evaluated in Ghana using the Intervention Mapping approach. SPEEK aimed at delaying sexual initiation, reducing sexually transmitted infections (STIs) and preventing pregnancy, targeting junior high school students in a West African rural setting.

Efficient design of cluster randomized trials with treatment-dependent costs and treatment-dependent unknown variances.

Cluster randomized trials evaluate the effect of a treatment on persons nested within clusters, where treatment is randomly assigned to clusters. Current equations for the optimal sample size at the cluster and person level assume that the outcome variances and/or the study costs are known and homogeneous between treatment arms. This paper presents efficient yet robust designs for cluster randomized trials with treatment-dependent costs and treatment-dependent unknown variances, and compares these with 2 practical designs.