2021, Article / Letter to editor (Quality of Life Research, (2021))Purpose Complementary interventions for persons with severe mental illness (SMI) focus on both personal recovery and illness self-management. This paper aimed to identify the patient-reported outcome measures (PROMs) associated with the most relevant and meaningful change in persons with SMI who attended the Illness Management and Recovery Programme (IMR). Methods The effect of the IMR was measured with PROMs concerning recovery, illness self-management, burden of symptoms and quality of life (QoL). From the QoL measures, an anchor was chosen based on the most statistically significant correlations with the PROMs. Then, we estimated the minimal important difference (MID) for all PROMs using an anchor-based method supported by distribution-based methods. The PROM with the highest outcome for effect score divided by MID (the effect/MID index) was considered to be a measure of the most relevant and meaningful change. Results All PROMs showed significant pre-post-effects. The QoL measure 'General Health Perception (Rand-GHP)' was identified as the anchor. Based on the anchor method, the Mental Health Recovery Measure (MHRM) showed the highest effect/MID index, which was supported by the distribution-based methods. Because of the modifying gender covariate, we stratified the MID calculations. In most MIDs, the MHRM showed the highest effect/MID indexes. Conclusion Taking into account the low sample size and the gender covariate, we conclude that the MHRM was capable of showing the most relevant and meaningful change as a result of the IMR in persons with SMI.
2020, Article / Letter to editor (Physical Therapy, vol. 100, iss. 4, (2020), pp. 653-661)BACKGROUND: Coach2Move is a personalized treatment strategy by physical therapists to elicit physical activity in community-dwelling older adults with mobility problems. OBJECTIVE: The primary objective of this study is to assess the effectiveness and cost-effectiveness of the implementation of Coach2Move compared with regular care physical therapy in daily clinical practice. DESIGN, SETTING, PARTICIPANTS, AND INTERVENTION: A multicenter cluster-randomized stepped wedge trial is being implemented in 16 physical therapist practices (4 clusters of 4 practices in 4 steps) in the Netherlands. The study aims to include 400 older adults (≥70 years) living independently with mobility problems and/or physically inactive lifestyles. The intervention group receives physical therapy conforming to the Coach2Move strategy; the usual care group receives typical physical therapist care. MEASUREMENTS: Measurements are taken at baseline and 3, 6, and 12 months after the start of treatment. The primary outcomes for effectiveness are the amount of physical activity (LASA Physical Activity Questionnaire) and functional mobility (Timed Up and Go test). Trial success can be declared if at least 1 parameter improves while another does not deteriorate. Secondary outcomes are level of frailty (Evaluative Frailty Index for Physical Activity), perceived effect (Global Perceived Effect and Patient Specific Complaints questionnaire), quality of life (EQ-5D-5 L), and health care expenditures. Multilevel linear regression analyses are used to compare the outcomes between treatment groups according to an intention-to-treat approach. Alongside the trial, a mixed-methods process evaluation is performed to understand the outcomes, evaluate therapist fidelity to the strategy, and detect barriers and facilitators in implementation. LIMITATIONS: An important limitation of the study design is the inability to blind treating therapists to study allocation. DISCUSSION: The trial provides insight into the effectiveness and cost-effectiveness of the Coach2Move strategy compared with usual care. The process evaluation provides insight into influencing factors related to outcomes and implementation.
2015, Article / Letter to editor (International Journal of Nursing Studies, vol. 52, iss. 1, (2015), pp. 112-120)Background: No-rinse disposable wash gloves are increasingly implemented in health care to replace traditional soap and water bed baths without proper evaluation of (cost) effectiveness. Objectives: To compare bed baths for effects on skin integrity and resistance against bathing and costs. Design: Cluster randomized trial. Setting: Fifty six nursing home wards in the Netherlands. Participants: Five hundred adult care-dependent residents and 275 nurses from nursing home wards. Methods: The experimental condition 'washing without water' consists of a bed bath with disposable wash gloves made of non-woven waffled fibers, saturated with a no-rinse, quickly vaporizing skin cleaning and caring lotion. The control condition is a traditional bed bath using soap, water, washcloths and towels. Both conditions were continued for 6 weeks. Outcome measures were prevalence of skin damage distinguished in two levels of severity: any skin abnormality/lesion and significant skin lesions. Additional outcomes: resistance during bed baths, costs. Results: Any skin abnormalities/lesions over time decreased slightly in the experimental group, and increased slightly in the control group, resulting in 72.7% vs 77.6% of residents having any skin abnormalities/lesions after 6 weeks, respectively (p= 0.04). There were no differences in significant skin lesions or resistance after 6 weeks. Mean costs for bed baths during 6 weeks per resident were estimated at 218.30 (95%Cl 150.52-286.08) in the experimental group and 232.20 (95%Cl: 203.80-260.60) in the control group (difference 13.90 (95%Cl: 25.61-53.42). Conclusion: Washing without water mildly protects from skin abnormalities/lesions, costs for preparing and performing bed baths do not differ from costs for traditional bed bathing. Thus, washing without water can be considered the more efficient alternative. (C) 2014 Elsevier Ltd. All rights reserved.
2012, Article / Letter to editor (Journal of Clinical Epidemiology, vol. 65, iss. 2, (2012), pp. 132-137)Objective: Balance of prognostic factors between treatment groups is desirable because it improves the accuracy, precision, and credibility of the results. In cluster-controlled trials, imbalance can easily occur by chance when the number of cluster is small. If all clusters are known at the start of the study, the "best balance" allocation method (BB) can be used to obtain optimal balance. This method will be compared with other allocation methods. Study Design and Setting: We carried out a simulation study to compare the balance obtained with BB, minimization, unrestricted randomization, and matching for four to 20 clusters and one to five categorical prognostic factors at cluster level. Results: BB resulted in a better balance than randomization in 13-100% of the situations, in 0-61% for minimization, and in 0-88% for matching. The superior performance of BB increased as the number of clusters and/or the number of factors increased. Conclusion: BB results in a better balance of prognostic factors than randomization, minimization, stratification, and matching in most situations. Furthermore, BB cannot result in a worse balance of prognostic factors than the other methods. (C) 2012 Elsevier Inc. All rights reserved.