Abstract Background: Patients with glioma often suffer from cognitive deficits. Physical exercise has been effective in ameliorating cognitive deficits in older adults and neurological patients. This pilot randomized controlled trial (RCT) explored the possible impact of an exercise intervention, designed to improve cognitive functioning in glioma patients, regarding cognitive test performance and patient-reported outcomes (PROs). Methods: Thirty-four clinically stable patients with World Health Organization grades II/III glioma were randomized to a home-based remotely coached exercise group or an active control group. Patients exercised 3 times per week for 20-45 minutes, with moderate to vigorous intensity, during 6 months. At baseline and immediate follow-up, cognitive performance and PROs were assessed with neuropsychological tests and questionnaires, respectively. Linear regression analyses were used to estimate effect sizes of potential between-group differences in cognitive performance and PROs at 6 months. Results: The exercise group (n = 21) had small- to medium-sized better follow-up scores than the control group (n = 11) on several measures of attention and information processing speed, verbal memory, and executive function, whereas the control group showed a slightly better score on a measure of sustained selective attention. The exercise group also demonstrated small- to medium-sized better outcomes on measures of self-reported cognitive symptoms, fatigue, sleep, mood, and mental health-related quality of life. Conclusions: This small exploratory RCT in glioma patients provides a proof of concept with respect to improvement of cognitive functioning and PROs after aerobic exercise, and warrants larger exercise trials in brain tumor patients.
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Background: Early childhood caries is considered one of the most prevalent diseases in childhood, affecting almost half of preschool-age children globally. In the Netherlands, approximately one-third of children aged 5 years already have dental caries, and dental care providers experience problems reaching out to these children. Objective: Within the proposed trial, we aim to test the hypothesis that, compared to children who receive usual care, children who receive the Toddler Oral Health Intervention as add-on care will have a reduced cumulative caries incidence and caries incidence density at the age of 48 months. Methods: This pragmatic, 2-arm, individually randomized controlled trial is being conducted in the Netherlands and has been approved by the Medical Ethics Research Board of University Medical Center Utrecht. Parents with children aged 6 to 12 months attending 1 of the 9 selected well-baby clinics are invited to participate. Only healthy children (ie, not requiring any form of specialized health care) with parents that have sufficient command of the Dutch language and have no plans to move outside the well-baby clinic region are eligible. Both groups receive conventional oral health education in well-baby clinics during regular well-baby clinic visits between the ages of 6 to 48 months. After concealed random allocation of interventions, the intervention group also receives the Toddler Oral Health Intervention from an oral health coach. The Toddler Oral Health Intervention combines behavioral interventions of proven effectiveness in caries prevention. Data are collected at baseline, at 24 months, and at 48 months. The primary study endpoint is cumulative caries incidence for children aged 48 months, and will be analyzed according to the intention-to-treat principle. For children aged 48 months, the balance between costs and effects of the Toddler Oral Health Intervention will be evaluated, and for children aged 24 months, the effects of the Toddler Oral Health Intervention on behavioral determinants, alongside cumulative caries incidence, will be compared. Results: The first parent-child dyads were enrolled in June 2017, and recruitment was finished in June 2019. We enrolled 402 parent-child dyads. Conclusions: All follow-up interventions and data collection will be completed by the end of 2022, and the trial results are expected soon thereafter. Results will be shared at international conferences and via peer-reviewed publication.
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Background: In 2009, the Steering Committee for Pregnancy and Childbirth in the Netherlands recommended the implementation of continuous care during labor in order to improve perinatal outcomes. However, in current care, routine maternity caregivers are unable to provide this type of care, resulting in an implementation rate of less than 30%. Maternity care assistants (MCAs), who already play a nursing role in low risk births in the second stage of labor and in homecare during the postnatal period, might be able to fill this gap. In this study, we aim to explore the (cost) effectiveness of adding MCAs to routine first- and second-line maternity care, with the idea that these MCAs would offer continuous care to women during labor. Methods: A randomized controlled trial (RCT) will be performed comparing continuous care (CC) with care-as-usual (CAU). All women intending to have a vaginal birth, who have an understanding of the Dutch language and are > 18 years of age, will be eligible for inclusion. The intervention consists of the provision of continuous care by a trained MCA from the moment the supervising maternity caregiver establishes that labor has started. The primary outcome will be use of epidural analgesia (EA). Our secondary outcomes will be referrals from primary care to secondary care, caesarean delivery, instrumental delivery, adverse outcomes associated with epidural (fever, augmentation of labor, prolonged labor, postpartum hemorrhage, duration of postpartum stay in hospital for mother and/or newborn), women’s satisfaction with the birth experience, cost-effectiveness, and a budget impact analysis. Cost effectiveness will be calculated by QALY per prevented EA based on the utility index from the EQ-5D and the usage of healthcare services. A standardized sensitivity analysis will be carried out to quantify the outcome in addition to a budget impact analysis. In order to show a reduction from 25 to 17% in the primary outcome (alpha 0.05 and bèta 0.20), taking into account an extra 10% sample size for multi-level analysis and an attrition rate of 10%, 2 × 496 women will be needed (n = 992). Discussion: We expect that adding MCAs to the routine maternity care team will result in a decrease in the use of epidural analgesia and subsequent costs without a reduction in patient satisfaction. It will therefore be a costeffective intervention. Trial registration: Trial Registration: Netherlands Trial Register, NL8065. Registered 3 October 2019 - Retrospectively registered.
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In BMC Oral Health verscheen het volgende artikel van Inholland-docente en promovenda Janneke Scheerman (en collega’s). Background: Adolescents with fixed orthodontic appliances are at high risk of developing dental caries. To date, new smartphone technologies have seldom been used to support them in the preventive behavior that can help prevent dental caries. After an intervention-mapping process, we developed a smartphone application (the WhiteTeeth app) for preventing dental caries through improved oral-health behavior and oral hygiene. The app, which is intended to be used at home, will help adolescents with fixed orthodontic appliances perform their oral self-care behavior. The app is based on the Health Action Process Approach (HAPA) theory, and incorporates several behavior-change techniques that target the psychosocial factors of oral-health behavior. This article describes the protocol of a randomized controlled trial (RCT) to evaluate the effects of the WhiteTeeth app on oral-health behavior and oral-hygiene outcomes (presence of dental plaque and gingival bleeding) compared with those of care as usual, in patients aged 12–16 with fixed orthodontic appliances.
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Objective:Acknowledging study limitations in a scientific publication is a crucial element in scientific transparency and progress. However, limitation reporting is often inadequate. Natural language processing (NLP) methods could support automated reporting checks, improving research transparency. In this study, our objective was to develop a dataset and NLP methods to detect and categorize self-acknowledged limitations (e.g., sample size, blinding) reported in randomized controlled trial (RCT) publications.Methods:We created a data model of limitation types in RCT studies and annotated a corpus of 200 full-text RCT publications using this data model. We fine-tuned BERT-based sentence classification models to recognize the limitation sentences and their types. To address the small size of the annotated corpus, we experimented with data augmentation approaches, including Easy Data Augmentation (EDA) and Prompt-Based Data Augmentation (PromDA). We applied the best-performing model to a set of about 12K RCT publications to characterize self-acknowledged limitations at larger scale.Results:Our data model consists of 15 categories and 24 sub-categories (e.g., Population and its sub-category DiagnosticCriteria). We annotated 1090 instances of limitation types in 952 sentences (4.8 limitation sentences and 5.5 limitation types per article). A fine-tuned PubMedBERT model for limitation sentence classification improved upon our earlier model by about 1.5 absolute percentage points in F1 score (0.821 vs. 0.8) with statistical significance (). Our best-performing limitation type classification model, PubMedBERT fine-tuning with PromDA (Output View), achieved an F1 score of 0.7, improving upon the vanilla PubMedBERT model by 2.7 percentage points, with statistical significance ().Conclusion:The model could support automated screening tools which can be used by journals to draw the authors’ attention to reporting issues. Automatic extraction of limitations from RCT publications could benefit peer review and evidence synthesis, and support advanced methods to search and aggregate the evidence from the clinical trial literature.
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Background: To facilitate adherence to adaptive pain management behaviors after interdisciplinary multimodal pain treatment, we developed a mobile health app (AGRIPPA app) that contains two behavior regulation strategies. Objective: The aims of this project are (1) to test the effectiveness of the AGRIPPA app on pain disability; (2) to determine the cost-effectiveness; and (3) to explore the levels of engagement and usability of app users. Methods: We will perform a multicenter randomized controlled trial with two parallel groups. Within the 12-month inclusion period, we plan to recruit 158 adult patients with chronic pain during the initial stage of their interdisciplinary treatment program in one of the 6 participating centers. Participants will be randomly assigned to the standard treatment condition or to the enhanced treatment condition in which they will receive the AGRIPPA app. Patients will be monitored from the start of the treatment program until 12 months posttreatment. In our primary analysis, we will evaluate the difference over time of pain-related disability between the two conditions. Other outcome measures will include health-related quality of life, illness perceptions, pain self-efficacy, app system usage data, productivity loss, and health care expenses. Results: The study was approved by the local Medical Research Ethics Committee in October 2019. As of March 20, 2020, we have recruited 88 patients. Conclusions: This study will be the first step in systematically evaluating the effectiveness and efficiency of the AGRIPPA app. After 3 years of development and feasibility testing, this formal evaluation will help determine to what extent the app will influence the maintenance of treatment gains over time. The outcomes of this trial will guide future decisions regarding uptake in clinical practice.
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Study design: A secondary analysis of a systematic review. Background: Manipulations or mobilizations are commonly used interventions in patients with mechanical neck pain. The treatment effects have often been studied in randomized controlled trials (RCT) which are generally considered the gold standard in evaluating the treatment effects, mainly due to its high internal validity. External validity is defined as the extent to which the effects can be generalised to clinical practice. An important prerequisite for this is that interventions used in clinical trials can be replicated in clinical practice. It can be questioned if interventions utilized in randomized controlled trials can be translated into clinical practice. Objectives: The overall aim of this study is to examine whether the quality of the description of manipulation and mobilization interventions is sufficient for to replication of these interventions in clinical practice. Methods: A comprehensive literature search was performed. Two independent researchers used the Template for Intervention Description and Replication (TIDieR) which is a 12-item checklist for describing the completeness of the interventions. Results: Sixty-seven articles were included that used manipulation and/or mobilization interventions for patients with mechanical neck pain. None of the articles describe the intervention e.g. all the items on the TIDieR list. Considering item 8 (a-f) of the TIDieR checklist only one article described the used techniques completely. Conclusion: Manipulation or a mobilization interventions are poorly reported in RCTs, which jeopardize the external validity of RCTs, making it difficult for clinicians and researchers to replicate these interventions.
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Background/Objectives: Homecare staff often take over activities instead of “doing activities with” clients, thereby hampering clients from remaining active in daily life. Training and supporting staff to integrate reablement into their working practices may reduce clients' sedentary behavior and improve their independence. This study evaluated the effectiveness of the “Stay Active at Home” (SAaH) reablement training program for homecare staff on older homecare clients' sedentary behavior. Design: Cluster randomized controlled trial (c-RCT). Setting: Dutch homecare (10 nursing teams comprising a total of 313 staff members). Participants: 264 clients (aged ≥65 years). Intervention: SAaH seeks to equip staff with knowledge, attitude, and skills on reablement, and to provide social and organizational support to implement reablement in homecare practice. SAaH consists of program meetings, practical assignments, and weekly newsletters over a 9-month period. The control group received no additional training and delivered care as usual. Measurements: Sedentary behavior (primary outcome) was measured using tri-axial wrist-worn accelerometers. Secondary outcomes included daily functioning (GARS), physical functioning (SPPB), psychological functioning (PHQ-9), and falls. Data were collected at baseline and at 12 months; data on falls were also collected at 6 months. Intention-to-treat analyses using mixed-effects linear and logistic regression were performed. Results: We found no statistically significant differences between the study groups for sedentary time expressed as daily minutes (adjusted mean difference: β 18.5 (95% confidence interval [CI] 22.4, 59.3), p = 0.374) and as proportion of wake/wear time (β 0.6 [95% CI 1.5, 2.6], p = 0.589) or for most secondary outcomes. Conclusion: Our c-RCT showed no evidence for the effectiveness of SAaH for all client outcomes. Refining SAaH, by adding components that intervene directly on homecare clients, may optimize the program and require further research. Additional research should explore the effectiveness of SAaH on behavioral determinants of clients and staff and cost-effectiveness.
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Het doel van de klinische forensische zorg, of meer specifiek de tbs-maatregel, is het beveiligen van de maatschappij; op korte termijn door iemand uit de maatschappij te halen en op langere termijn door behandeling gericht op het verlagen van risicofactoren en het opbouwen of versterken van beschermende factoren. In de media verschijnen met enige regelmaat kritische verhalen over de forensische zorg, meestal naar aanleiding van een ernstig incident, zoals een delict gepleegd door een tbs-patiënt op verlof. De vraag die daarbij steeds wordt opgeworpen, is hoe effectief de tbs-maatregel en behandeling in de forensische zorg is. Het is logisch dat er maatschappelijke onrust ontstaat bij ernstige incidenten en de opgeworpen vragen vanuit de maatschappij zijn terecht. Toch is enige nuancering hier op zijn plaats, aangezien recidive tijdens forensische behandeling uitzonderlijk is. Zo werd in een recent onderzoek met gegevens van het Adviescollege Verloftoetsing tbs (AVT) gevonden dat slechts bij 0,15% van de 15.050 positief beoordeelde verlofaanvragen sprake was van een ongeoorloofde afwezigheid met recidive. Verder blijkt al jaren uit onderzoek van het Wetenschappelijk Onderzoek- en Datacentrum (WODC) dat ernstige recidive na ontslag uit de forensische zorg, met name de tbs, relatief laag is, in ieder geval aanzienlijk lager dan na een gevangenisstraf. Hierbij dient aangetekend te worden dat de cijfers lastig te vergelijken zijn vanwege belangrijke verschillen tussen de groepen. De recidivecijfers tijdens en na forensische zorg zijn dus relatief gunstig, maar een delict kan enorme impact hebben en het zo veel mogelijk voorkomen van recidive blijft het ultieme doel van de behandeling in de forensische zorg. Het is nog onduidelijk wat precies bijdraagt aan recidivereductie en hoe behandeleffectiviteit of behandelsucces gedefinieerd kan worden.
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Low-grade inflammation and metabolic syndrome are seen in many chronic diseases, including rheumatoid arthritis (RA) and osteoarthritis (OA). Lifestyle interventions which combine different non-pharmacological therapies have shown synergizing effects in improving outcomes in patients with other chronic diseases or increased risk thereof, especially cardiovascular disease. For RA and metabolic syndrome-associated OA (MSOA), whole food plant-based diets (WFPDs) have shown promising results. A WFPD, however, had not yet been combined with other lifestyle interventions for RA and OA patients. In this protocol paper, we therefore present Plants for Joints, a multidisciplinary lifestyle program, based on a WFPD, exercise, and stress management. The objective is to study the effect of this program on disease activity in patients with RA (randomized controlled trial [RCT] 1), on a risk score for developing RA in patients with anti-citrullinated protein antibody (ACPA) positive arthralgia (RCT 2) and on pain, stiffness, and function in patients with MSOA (RCT 3), all in comparison with usual care.We designed three 16-week observer-blind RCTs with a waiting-list control group for patients with RA with low to moderate disease activity (2.6 ≤ Disease Activity Score [DAS28] ≤ 5.1, RCT 1, n = 80), for patients at risk for RA, defined by ACPA-positive arthralgia (RCT 2, n = 16) and for patients with metabolic syndrome and OA in the knee and/or hip (RCT 3, n = 80). After personal counseling on diet and exercise, participants join 10 group meetings with 6-12 other patients to receive theoretical and practical training on a WFPD, exercise, and stress management, while medication remains unchanged. The waiting-list control group receives usual care, while entering the program after the RCT. Primary outcomes are: difference in mean change between intervention and control groups within 16 weeks for the DAS28 in RA patients (RCT 1), the RA-risk score for ACPA positive arthralgia patients (RCT 2), and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score for MSOA patients (RCT 3). Continued adherence to the lifestyle program is measured in a two-year observational extension study.
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