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Simple Summary: We studied children with cancer who receive vincristine chemotherapy as a one-hour infusion and compared them to children who received vincristine as a push injection. We investigated if there was a difference in the development of vincristine induced peripheral neuropathy, the most common side effect of vincristine. We found that in general there were no differences between the two groups (one-hour group versus push group). However, in children using both vincristine and azole antifungals, we noticed that children who received vincristine as a one-hour infusion experienced less severe vincristine induced peripheral neuropathy compared to children who received vincristine as a push injection. Therefore, in children who require both azole antifungal medication as well as vincristine it might be beneficial to administer the vincristine as a one-hour infusion instead of a push injection. However, this finding needs to be confirmed in other studies as well. Vincristine (VCR) is a frequently used chemotherapeutic agent. However, it can lead to VCR-induced peripheral neuropathy (VIPN). In this study we investigated if one-hour infusions of VCR instead of push-injections reduces VIPN in pediatric oncology patients. We conducted a multicenter randomized controlled trial in which participants received all VCR administrations through push injections or one-hour infusions. VIPN was measured at baseline and 1–5 times during treatment using Common Terminology Criteria of Adverse Events (CTCAE) and pediatric-modified Total Neuropathy Score. Moreover, data on co-medication, such as azole antifungals, were collected. Overall, results showed no effect of administration duration on total CTCAE score or ped-mTNS score. However, total CTCAE score was significantly lower in patients receiving one-hour infusions concurrently treated with azole antifungal therapy (β = -1.58; p = 0.04). In conclusion, generally VCR administration through one-hour infusions does not lead to less VIPN compared to VCR push injections in pediatric oncology patients. However, one-hour infusions lead to less severe VIPN compared to push-injections when azole therapy is administered concurrently with VCR. These results indicate that in children treated with VCR and requiring concurrent azole therapy, one-hour infusions might be beneficial over push injections, although larger trials are needed to confirm this association. [ABSTRACT FROM AUTHOR]

Objective: To study whether intrauterine application of auto-crosslinked polymers of hyaluronic acid (ACP) gel after dilation and curettage (D&C) improves reproductive outcomes.Design: Follow-up of a prospective randomized trial.Setting: University and university-affiliated teaching hospitals.Patient(s): Women with a miscarriage at <14 weeks' gestation with at least one previous D&C were randomized to D&C plus ACP gel (intervention) or D&C alone (control). A hysteroscopy was performed after 8-12 weeks, and if intrauterine adhesion (IUAs) were encountered, adhesiolysis was executed.Intervention(s): Participants received a questionnaire 30 months after treatment.Main Outcome Measure(s): Ongoing pregnancy and outcome of subsequent pregnancies.Result(s): Ongoing pregnancies were recorded in 74.6% (50/67) of the intervention group versus 67.2% (43/64) of the control group, and in, respectively, 94.3% (50/53) versus 71.7% (43/60) in the women wishing to conceive. The median times to conception leading to a live birth were, respectively, 21.9 versus 36.1 months. Reduced menstrual blood loss was reported in 7.5% (5/67) versus 20.3% (13/64) and dysmenorrhea in 14.9% (10/67) versus 34.4% (22/64), respectively.Conclusion(s): Application of ACP gel following D&C performed after miscarriage seems to have a favorable effect on subsequent reproductive outcomes in women with at least one previous D&C. Given the fact that the study was not powered for reproductive outcomes, the data should be interpreted with caution. The effect may be underestimated due to routine removal of IUAs.Dutch Clinical Trial Registry Number: NTR 3120. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To investigate the effect of a medical food on cognitive function in people with mild Alzheimer''s disease (AD). Methods: A total of 225 drug-naïve AD patients participated in this randomized, double-blind controlled trial. Patients were randomized to active product, Souvenaid, or a control drink, taken once-daily for 12 weeks. Primary outcome measures were the delayed verbal recall task of the Wechsler Memory Scale–revised, and the 13-item modified Alzheimer''s Disease Assessment Scale–cognitive subscale at week 12. Results: At 12 weeks, significant improvement in the delayed verbal recall task was noted in the active group compared with control (P = .021). Modified Alzheimer''s Disease Assessment Scale–cognitive subscale and other outcome scores (e.g., Clinician Interview Based Impression of Change plus Caregiver Input, 12-item Neuropsychiatric Inventory, Alzheimer''s disease Co-operative Study–Activities of Daily Living, Quality of Life in Alzheimer''s Disease) were unchanged. The control group neither deteriorated nor improved. Compliance was excellent (95%) and the product was well tolerated. Conclusions: Supplementation with a medical food including phosphatide precursors and cofactors for 12 weeks improved memory (delayed verbal recall) in mild AD patients. This proof-of-concept study justifies further clinical trials. [Copyright &y& Elsevier]

To investigate whether an electronic health record (EHR)–integrated decision tool, combined with supportive interventions, results in more appropriate antibiotic prescribing in nursing home (NH) residents with suspected urinary tract infection (UTI), without negative consequences for residents. Cluster randomized controlled trial with NHs as the randomization unit; intervention group NHs received the EHR-integrated decision tool and supportive interventions, and control group NHs provided care as usual. 212 residents with suspected UTI, from 16 NHs in the Netherlands. Physicians collected data at index consultation (ie, UTI suspicion) and during a 21-day follow-up period (March 2019–March 2020). Overall antibiotic prescribing data at NH level, 12 months prior to and during the study, was derived from the electronic prescribing system. The primary study outcome was the percentage of antibiotic prescriptions for suspected UTI that was appropriate, at index consultation. Secondary study outcomes included changes in treatment decision, complications, UTI-related hospitalization, and mortality during follow-up; and pre-post study changes in antibiotic prescribing at the NH level. 295 suspected UTIs were included (intervention group: 189; control group: 106). The between-group difference in appropriate antibiotic prescribing was 13% [intervention group: 62%, control group: 49%; adjusted odds ratio (OR) 1.43, 95% CI 0.57-3.62]. In both groups, complications (2% vs 3%), UTI-related hospitalization (2% vs 1%), and possible UTI-related mortality (2% vs 2%) were rare. The pre-post study difference in antibiotic prescriptions per 1000 resident-care days was −0.95 in the intervention group NHs and −0.05 in the control group NHs (P =.02). Although appropriate antibiotic prescribing improved in the intervention group, this does not provide sufficient evidence for our multidisciplinary intervention. Despite this inconclusive result, our intervention could potentially still be effective, because we established a large reduction in the number of antibiotic prescriptions in the intervention group. [ABSTRACT FROM AUTHOR]

Introduction: Cognitive training (CT) has been proposed as a treatment option for cognitive impairment in Parkinson's disease (PD). We aimed to assess the efficacy of adaptive, computerized CT on cognitive function in PD.Methods: In this double-blind, randomized controlled trial we enrolled PD patients that experienced substantial subjective cognitive complaints. Over a period of eight weeks, participants underwent 24 sessions of computerized multi-domain CT or an active control intervention for 45 min each (randomized 1:1). The primary outcome was the accuracy on the Tower of London task; secondary outcomes included effects on other neuropsychological outcomes and subjective cognitive complaints. Outcomes were assessed before and after training and at six-months follow-up, and analyzed with multivariate mixed-model analyses.Results: The intention-to-treat population consisted of 136 participants (n = 68 vs. n = 68, age M: 62.9y, female: 39.7%). Multivariate mixed-model analyses showed no group difference on the Tower of London accuracy corrected for baseline performance (n = 130): B: -0.06, 95% CI: -0.27 to 0.15, p = 0.562. Participants in the CT group were on average 0.30 SD (i.e., 1.5 s) faster on difficulty load 4 of this task (secondary outcome): 95% CI: -0.55 to -0.06, p = 0.015. CT did not reduce subjective cognitive complaints. At follow-up, no group differences were found.Conclusions: This study shows no beneficial effect of eight-week computerized CT on the primary outcome (i.e., planning accuracy) and only minor improvements on secondary outcomes (i.e., processing speed) with limited clinical impact. Personalized or ecologically valid multi-modal intervention methods could be considered to achieve clinically meaningful and lasting effects. [ABSTRACT FROM AUTHOR]

Abstract: Background and Objective: Assessing levels and determinants of physical activity as outcome measurements might have an independent effect on participan's physical activity behavior. The objective is to study this effect in a randomized controlled trial (RCT) promoting regular physical activity in Dutch general practice. Methods: Using a Solomon four-group design, participants were randomized twice. After randomization to a control or intervention-condition at general practice level (N = 29), participants were randomized to a group participating in measurements at baseline, 2 and 6 months (3M-group, N = 361), or a group only participating in measurements at 6 months (1M-group, N = 356). Outcome measures assessed at 6 months included: level of physical activity (self-reported and objectively measured with accelerometry), meeting ACSM/CDC guideline for regular physical activity, stage of change, and determinants of physical activity. Results: Follow-up data on 635 participants (89%) was collected. Statistically significant measurement effects were found for meeting the ACSM/CDC guideline (self-reported), self-efficacy for resisting relapse, knowledge, and on awareness. Other outcome measures showed positive trends, except stages of change. Conclusion: Measurements of physical activity affect participant's physical activity behavior, possibly triggered by a raised awareness about their own physical activity level. Implications for future research are discussed, as well as methodologic limitations of the study design. [Copyright &y& Elsevier]

Physical activity in people with dementia (PwD) may enhance physical and mental functioning. Exergaming, which combines physical exercise with cognitive stimulation in a gaming environment, was developed to overcome barriers in performing physical activities. We evaluated the effects of exergaming in day care centers (DCCs) for PwD and informal caregivers (ICs). A randomized controlled trial among 23 DCCs across the Netherlands randomized to exergaming (interactive cycling during 6 months) or a care-as-usual control group. A total of 112 (73 exergaming, 39 control) community-dwelling dyads (PwD, IC), with the PwD visiting a DCC at least twice per week. All outcomes were assessed using structured questionnaires during interviews with PwD and ICs at baseline (T0), 3 months (T1), and 6 months (T2). Primary outcomes: physical activity and mobility of the PwD. Secondary outcomes: physical, cognitive, emotional and social functioning, and quality of life for PwD. For ICs: experienced burden, quality of life, and positive care experiences. Mixed-model analyses showed no statistically significant effects on primary outcomes. There were statistically significant positive effects on PwD's secondary outcomes at T2 on cognition [Mini-Mental State Examination (MMSE): r = 2.30, 95% confidence interval (CI): 0.65, 3.96, P =.007; and Trail Making Test part A (TMT-A): r = −28.98, 95% CI: −54.89, −3.08, P =.029], social functioning (Behavior Observation Scale for Intramural Psychogeriatrics subscale 1 (GIP): r = −1.86, 95% CI: −3.56, −0.17, P =.031), and positive post-test effects in ICs on distress caused by the PwD's neuropsychiatric symptoms (NPI-Q total distress: r = −3.30, 95% CI: −6.57, −0.03, P =.048) and on sense of competence (SSCQ: r = 2.78, 95% CI: 0.85, 4.71, P =.005). Exergaming appeared not effective on the primary outcomes. Despite the study being underpowered, we found positive effects on secondary outcomes for PwD and ICs, and no negative effects. We therefore recommend further study, dissemination, and implementation. [ABSTRACT FROM AUTHOR]

Background: In Parkinson's disease (PD) patients, fluctuations in symptoms commonly occur after many years of dopamine replacement therapy. The so-called wearing-off phenomenon exists of both motor and non-motor symptoms, such as rigidity and anxiety. Current treatment options are limited and an integrated approach is needed to address the complex interactions between motor and non-motor symptoms. Since wearing-off is eventually inevitable, treatment needs to focus on coping, acceptance and self-efficacy. We developed the body awareness training, named BEWARE, combining physical therapy with acceptance and commitment therapy to help PD patients deal better with wearing-off related anxiety (WRA).Methods: This was an investigator-blinded randomized controlled trial. Forty PD patients with WRA were randomly assigned to the BEWARE or to the treatment as usual (TAU) condition. Assessments were performed prior to and immediately after the treatment period, and at 3-months follow up. The primary outcome was self-efficacy, secondary outcomes focused on mobility, daily functioning, anxiety, depression and quality of life.Results: There was no significant improvement in self-efficacy in the BEWARE treatment condition when compared to TAU. However, standing balance and emotional wellbeing showed a significant improvement, and feelings of stigmatization showed a trend-significant decrease in the BEWARE condition.Conclusions: We consider the BEWARE training to be a promising therapeutic approach to address WRA. Improvement points from the participants included 1) less frequent but longer therapy sessions; 2) active involvement of caregivers; and 3) the development of a supportive workbook. The optimized treatment protocol needs further evaluation in a phase III RCT.Trial Registration: ClinicalTrials.gov identifier: NCT02054845. [ABSTRACT FROM AUTHOR]

: BackgroundPhysical inactivity and obesity are major public health problems. Our objective was to investigate the effectiveness of an individual counseling intervention at the workplace on physical activity fitness and health. Counseling content derived from the Patient-centered Assessment and Counseling for Exercise and Nutrition (PACE) program.: MethodsA total of 299 employees of three municipal services in the Dutch town of Enschede were randomly allocated into intervention (n =131) and control group (n =168). Over a 9-month period, intervention group subjects were offered seven counseling sessions. Counseling was based on the individual’s stage of behavioral change using PACE physical activity and nutrition protocols. Subjects in both the intervention and control group received written information about several lifestyle factors. Primary outcome measures were physical activity (total energy expenditure, during sports activities, during physical activity leisure time other than sports, and meeting the moderate-intensity public health recommendations); cardiorespiratory fitness; and prevalence of musculoskeletal symptoms. Secondary outcome measures were body composition (body mass index [BMI], and percentage of body fat measured via skinfold thicknesses); blood pressure; and blood cholesterol.: ResultsThere were significant positive effects on total energy expenditure, physical activity during sports, cardiorespiratory fitness, percentage of body fat, and blood cholesterol. No effects were found for the proportion of subjects meeting the public health recommendation of moderate-intensity physical activity, physical activity during leisure time other than sports, prevalence of musculoskeletal symptoms, body mass index, and blood pressure.: ConclusionsIndividual face-to-face counseling at the workplace based on PACE protocols positively influenced physical activity levels and some components of physical fitness. The implementation of workplace counseling programs for individuals should therefore be promoted. [Copyright &y& Elsevier]

Abstract: Objectives: The Grip on Challenging Behavior care program was developed using the current guidelines and models on managing challenging behavior in dementia in nursing homes. It was hypothesized that the use of the care program would lead to a decrease in challenging behavior and in the prescription of psychoactive drugs without increase in use of restraints. Design: A randomized controlled trial was undertaken using a stepped-wedge design to implement the care program and to evaluate the effects. An assessment of challenging behavior and psychoactive medication was undertaken every 4 months on all participating units followed by the introduction of the care program in a group of 3 to 4 units. A total of 6 time assessments took place over 20 months. Setting: Seventeen dementia special care units of different nursing homes. Participants: A total of 659 residents of dementia special care units. All residents with dementia on the unit were included. Units were assigned by random allocation software to 1 of 5 groups with different starting points for the implementation of the care program. Intervention: A care program consisting of various assessment procedures and tools, which ensure a multidisciplinary approach and which structure the process of managing challenging behavior in dementia. Measurements: Challenging behavior was measured using the Cohen-Mansfield Agitation Inventory (CMAI) and the Neuropsychiatric Inventory. Research assistants (blinded for intervention status of the unit) interviewed nurses on the units about challenging behavior. Data on psychoactive drugs and restraints were retrieved from resident charts. Results: A total of 2292 assessments took place involving 659 residents (1126 control measurements, 1166 intervention measurements). The group of residents who remained in the intervention condition compared with the group in the control condition differed significantly in the CMAI change scores between successive assessments [–2.4 CMAI points, 95% confidence interval (CI) –4.3 to –0.6]. No significant effects were found for the control-to-intervention group compared with the group who remained in the control group (0.0 CMAI points, 95% CI –2.3 to 2.4). Significant effects were found on 5 of the 12 Neuropsychiatric Inventory items and on the use of antipsychotics (odds ratio 0.54, 95% CI 0.37– 0.80) and antidepressants (odds ratio 0.65, 95% CI 0.44–0.94). No effect on use of restraints was observed. Conclusions: The Grip on Challenging behavior program was able to diminish some forms of challenging behavior and the use of psychoactive drugs. [Copyright &y& Elsevier]