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Background An increase in infections after transrectal prostate biopsy (PB), related to an increasing number of patients with ciprofloxacin-resistant rectal flora, necessitates the exploration of alternatives for the traditionally used empirical prophylaxis of ciprofloxacin. We compared infectious complication rates after transrectal PB using empirical ciprofloxacin prophylaxis versus culture-based prophylaxis. Methods In this nonblinded, randomized trial, between 4 April 2018 and 30 July 2021, we enrolled 1538 patients from 11 Dutch hospitals undergoing transrectal PB. After rectal swab collection, patients were randomized 1:1 to receive empirical prophylaxis with oral ciprofloxacin (control group [CG]) or culture-based prophylaxis (intervention group [IG]). Primary outcome was any infectious complication within 7 days after biopsy. Secondary outcomes were infectious complications within 30 days, and bacteremia and bacteriuria within 7 and 30 days postbiopsy. For primary outcome analysis, the χ2 test stratified for hospitals was used. Trial registration number: NCT03228108. Results Data from 1288 patients (83.7%) were available for analysis (CG, 652; IG, 636). Infection rates within 7 days postbiopsy were 4.3% (n = 28) (CG) and 2.5% (n = 16) (IG) (P value =.08; reduction: −1.8%; 95% confidence interval, −.004 to.040). Ciprofloxacin-resistant bacteria were detected in 15.2% (n = 1288). In the CG, the presence of ciprofloxacin-resistant rectal flora resulted in a 6.2-fold higher risk of early postbiopsy infection. Conclusions Our study supports the use of culture-based prophylaxis to reduce infectious complications after transrectal PB. Despite adequate prophylaxis, postbiopsy infections can still occur. Therefore, culture-based prophylaxis must be weighed against other strategies that could reduce postbiopsy infections. Clinical Trials Registration. NCT03228108. [ABSTRACT FROM AUTHOR]

Objective The purpose of this study was to assess whether the superior cost-effectiveness of a personalized physical therapy approach (Coach2Move)—which was demonstrated in a previous trial compared with usual care physical therapy (UCP)—can be replicated in daily clinical practice. Methods A multicenter, cluster-randomized, stepped wedge trial with 4 clusters consisting of 4 physical therapist practices in the Netherlands was used to compare a personalized physical therapy approach to elicit physical activity (Coach2Move) versus care as usual. Multilevel analyses for effectiveness were conducted for the amount of physical activity (Longitudinal Aging Study Amsterdam Physical Activity Questionnaire) and functional mobility (Timed "Up & Go" Test) at 3, 6 (primary outcome), and 12 months' follow-up. Secondary outcomes were level of frailty (Evaluative Frailty Index for Physical Activity), perceived effect (Global Perceived Effect and Patient-Specific Complaints Questionnaires), quality of life (Euro Quality of Life-5 Dimensions-5 Levels [EQ-5D-5L]), and health care expenditures. Results The 292 community-dwelling older adults with mobility problems visiting physical therapists were included in either the Coach2Move (n = 112; mean [SD] age = 82 [5] years; 60% female) or UCP (n = 180; mean [SD] age = 81 (6) years; 62% female) section of the trial. At baseline, Coach2Move participants were less physically active compared with UCP participants (mean difference = −198; 95% CI = −90 to −306 active minutes). At 6 months, between-group mean differences [95% CI] favored Coach2Move participants on physical activity levels (297 [83 to 512] active minutes), functional mobility (−14.2 [−21 to −8]) seconds), and frailty levels (−5 [−8 to −1] points). At 12 months, the physical activity levels of Coach2Move participants further increased, and frailty levels and secondary outcomes remained stable, whereas outcomes of UCP participants decreased. After the Coach2Move implementation strategy, physical therapists utilized significantly fewer treatment sessions compared with before the implementation (15 vs 22). Anticipated cost savings were not observed. Conclusion This study replicated the results of an earlier trial and shows that Coach2Move leads to better mid- and long-term outcomes (physical activity, functional mobility, level of frailty) in fewer therapy sessions compared with UCP. Based on these and earlier findings, the implementation of Coach2Move in physical therapist practice is recommended. Impact This article describes the implementation of the Coach2Move approach, a treatment strategy that has proven to be cost-effective in a previously conducted randomized controlled trial. Implementation of Coach2Move in a real-life setting allowed an evaluation of the effects in a clinically relevant population. Coach2Move has been shown to increase physical activity, improve functional mobility, and reduce frailty more effectively compared with UCP therapy and therefore has application for physical therapists working with older adults in daily clinical practice. Lay summary Coach2Move is a new physical therapy approach for older adults. Implementation of Coach2Move in daily clinical practice can help people better outcomes over a longer period of time against similar costs compared with regular physical therapy. [ABSTRACT FROM AUTHOR]

Background: Disease severity in spinocerebellar ataxia type 3 (SCA3) is commonly defined by the Scale for the Assessment and Rating of Ataxia (SARA) sum score, but little is known about the contributions and progression patterns of individual items.Objectives: To investigate the temporal dynamics of SARA item scores in SCA3 patients and evaluate if clinical and demographic factors are differentially associated with evolution of axial and appendicular ataxia.Methods: In a prospective, multinational cohort study involving 11 European and 2 US sites, SARA scores were determined longitudinally in 223 SCA3 patients with a follow-up assessment after 1 year.Results: An increase in SARA score from 10 to 20 points was mainly driven by axial and speech items, with a markedly smaller contribution of appendicular items. Finger chase and nose-finger test scores not only showed the lowest variability at baseline, but also the least deterioration at follow-up. Compared with the full set of SARA items, omission of both tests would result in lower sample size requirements for therapeutic trials. Sex was associated with change in SARA sum score and appendicular, but not axial, subscore, with a significantly faster progression in men. Despite considerable interindividual variability, the average annual progression rate of SARA score was approximately three times higher in subjects with a disease duration over 10 years than in those within 10 years from onset.Conclusion: Our findings provide evidence for a difference in temporal dynamics between axial and appendicular ataxia in SCA3 patients, which will help inform the design of clinical trials and development of new (etiology-specific) outcome measures. © 2022 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society. [ABSTRACT FROM AUTHOR]

Objective: Hypoglycemia poses an immediate threat for cognitive function. Due to its association with acute cognitive impairment, the International Hypoglycemia Study Group (IHSG) defines a blood glucose level <3.0 mmol/L as "level 2 hypoglycemia." In the current study we investigated whether having diabetes, type of diabetes, or hypoglycemia awareness moderates this association.Research Design and Methods: Adults with type 1 diabetes with normal (n = 26) or impaired (n = 21) hypoglycemic awareness or with insulin-treated type 2 diabetes (n = 15) and age-matched control subjects without diabetes (n = 32) underwent a hyperinsulinemic-euglycemic-hypoglycemic glucose clamp (2.80 ± 0.13 mmol/L [50.2 ± 2.3 mg/dL]). At baseline and during hypoglycemia, calculation ability, attention, working memory and cognitive flexibility were measured with the Paced Auditory Serial Addition Test (PASAT) and the Test of Attentional Performance (TAP).Results: For the whole group, hypoglycemia decreased the mean ± SD proportion of correct answers on the PASAT by 8.4 ± 12.8%, increased reaction time on the TAP Alertness task by 32.1 ± 66.6 ms, and increased the sum of errors and omissions on the TAP Working Memory task by 2.0 ± 5.5 (all P < 0.001). Hypoglycemia-induced cognitive declines were largely irrespective of the presence or type of diabetes, level of symptomatic awareness, diabetes duration, or HbA1c.Conclusions: IHSG level 2 hypoglycemia impairs cognitive function in people with and without diabetes, irrespective of type of diabetes or hypoglycemia awareness status. These findings support the cutoff value of hypoglycemia <3.0 mmol/L (<54 mg/dL) as being clinically relevant for most people with diabetes. [ABSTRACT FROM AUTHOR]

Objective. Ultrasonography (US) can be used for treatment decisions in RA patients. This study investigated the added value of US to clinical variables in predicting flare in RA patients with longstanding low disease activity when stopping TNF inhibitors (TNFi). Methods. Cox models with and without using US added to clinical variables were developed in the Potential Optimization of Expediency of TNFi-UltraSonography study. RA patients (n = 259), using >1 year TNFi and csDMARD with DAS28<3.2 for 6months prior to inclusion, were followed for 52 weeks after stopping TNFi. The added value of US was assessed in two ways: first, by the extent to which individual predictions for flare at 52 weeks with and without US differed; and second, by comparing how US information improved the prediction to classify patients at 52 weeks in the low risk (<33% flare), intermediate risk (33-50%) and high risk (50-100%) groups. Results. Although US was predictive of flare at group level (multivariate hazard ratio = 1.7; 95% CI: 1.1, 2.5), individual predictions for flare at 52 weeks with and without US differed little (median difference 3.7%; interquartile range: -7.8 to 6.5%). With US, 15.9% of patients were designated low risk; without US, 14.6%. In fact, 12.0% of patients were US-classified as low risk with/without knowing US. Conclusion. In RA patients with longstanding low disease activity, at time of stopping TNFi, US is a predictor for flare at group level, but at the patient level, US has limited added value when common clinical parameters are used already, though the predictive value of clinical predictors is modest as well. [ABSTRACT FROM AUTHOR]

Objective: Evaluate the effectiveness of a training package to implement a community occupational therapy program for people with dementia and their caregiver (COTiD). Design: Cluster randomized controlled trial. Subjects: A total of 45 service units including 94 occupational therapists, 48 managers, 80 physicians, treating 71 client-caregiver couples. Interventions: Control intervention: A postgraduate course for occupational therapists only. Experimental intervention: A training package including the usual postgraduate course, additional training days, outreach visits, regional meetings, and access to a reporting system for occupational therapists. Physicians and managers received newsletters, had access to a website, and were approached by telephone. Main measures: Primary outcome: The intended adherence of therapists to the COTiD program. This was assessed using vignettes. Secondary outcomes: clients’ daily functioning, caregivers’ sense of competence, quality of life, and self-perceived performance of daily activities of both clients and caregivers. Between-group differences were assessed using multilevel analyses with therapist and intervention factors as covariates. Results: No significant between-group differences between baseline and 12 months were found for adherence (1.58, 95% CI −0.10 to 3.25), nor for any client or caregiver outcome. A higher number of coaching sessions and higher self-perceived knowledge of dementia at baseline positively correlated with adherence scores. In contrast, experiencing more support from occupational therapy colleagues or having conducted more COTiD treatments at baseline negatively affected adherence scores. Conclusion: The training package was not effective in increasing therapist adherence and client–caregiver outcomes. This study suggests that coaching sessions and increasing therapist knowledge on dementia positively affect adherence. Clinical trial number: NCT01117285 [ABSTRACT FROM AUTHOR]

Purpose: To date, the interchangeability of generic drugs has only been investigated for a limited number of medicines. The objective of this study was to investigate generic-generic drug interchangeability in a large subset of generic formulations in order to cover a broad spectrum of drugs. Methods: Orally administered drugs for investigation in this study were selected using strict, predefined criteria, with the purpose to avoid bias. This selection procedure yielded atorvastatin, bicalutamide, naratriptan, olanzapine, perindopril, and venlafaxine. Further, ciclosporin, tacrolimus, and mycophenolate mofetil were investigated as test immunosuppressants. Adjusted indirect comparisons were conducted between generic drugs containing the same active substance, and the 90 % confidence interval (CI) for AUC and C was calculated. Results: In total, 120 bioequivalence studies were identified in the Dutch medicine regulatory agency's database, allowing 292 indirect comparisons between generic drugs. The indirect comparison results indicated that in the vast majority of cases, i.e., 80.5 %, the 90 % CIs for both AUC and C fell within the bioequivalence criteria (in 90.1 and 87.0 % for AUC and C, respectively). In 1 % of the 292 indirect comparison for AUC and 3 % for C, a wider range of 75-133 % (or 80-125 %) was exceeded. Conclusions: Overall, our study suggests that exposure-related risks associated with the exchange of different generic drugs in clinical practice are not increased to a relevant extent compared to the situation in which a generic is exchanged with the innovator. [ABSTRACT FROM AUTHOR]

Aims and objectives This study seeks (1) to investigate the impact of the implementation of the 'Diagnostic Guideline for Anxiety and challenging behaviours in clients with intellectual disability' on nurses/social workers' knowledge and self-efficacy; and (2) to evaluate the role of nurses/social workers in the diagnostic process when applying the guideline. Background Nurses/social workers have extensive contact with clients with intellectual disabilities. Despite this key position, the contribution of nurses/social workers to the diagnosis of mental health problems and challenging behaviours is rather limited. The authors developed the multidimensional 'Diagnostic Guideline for Anxiety and challenging behaviours'. In this article, the implementation of this guideline is evaluated concerning knowledge and self-efficacy of nurses/social workers, as well the role of nurses/social workers in the diagnostic process. Design This study employed a comparative multiple case study design. Methods Qualitative and quantitative research methods. Results Working with the 'Diagnostic Guideline for Anxiety and challenging behaviours' led to a statistically significant increase in knowledge and self-efficacy among the nurses/social workers in the experimental condition, compared with nurses/social workers in the control condition. Nurses/social workers and psychologists appreciated the more active contribution of the nurses/social workers in the diagnostic process. Conclusions Working with the guideline increased the knowledge and self-efficacy of nurses/social workers, and led to more active participation of nurses/social workers in the diagnostic process. Relevance to clinical practice After following a training programme, nurses/social workers can effectively contribute to the diagnostic process in clients with anxiety and related challenging behaviours. [ABSTRACT FROM AUTHOR]

Background. Metastatic colorectal cancer (CRC) is predominantly a disease of the elderly, therefore the current standards should be evaluated in this population. Material and methods. We evaluated in different age groups the outcome in terms of median overall and progression-free survival, response rate, disease control rate, relative dose intensity (RDI), tolerability, and global quality of life (QoL) of first-line capecitabine monotherapy (CAP) versus capecitabine + irinotecan (CAPIRI) and capecitabine + oxaliplatin + bevacizumab (CAPOX + BEV) in the CAIRO and CAIRO2 study, respectively. Patients were categorized into three age groups: age > 75, 70-75 and < 70 years. Results. Clinical outcomes were not significantly different among age groups, with the exception of a higher response rate from CAP treatment in the elderly. Elderly patients treated with CAPOX + BEV showed a trend towards a worse median overall survival compared to younger patients. Only treatment with CAP resulted in a higher incidence of grade 3-4 toxicity and a lower RDI in elderly versus younger patients. Treatment with CAP and CAPOX + BEV in elderly patients was significantly more often discontinued due to toxicity instead of progression to disease compared to younger patients. The increase in global QoL was comparable for the three age groups for each treatment regimen. Conclusion. We did not observe significant differences in survival outcomes between elderly and younger metastatic CRC patients with three different first-line systemic treatment regimens. Our data suggest that initial dose reduction of CAP monotherapy may be indicated in elderly patients. [ABSTRACT FROM AUTHOR]

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%CI 150.52-286.08) in the experimental group and €232.20 (95% CI: 203.80-260.60) in the control group (difference €13.90 (95%CI: 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. [ABSTRACT FROM AUTHOR]

Neuropsychiatric symptoms are common in nursing home residents with young-onset dementia and burdensome for nursing staff. It is known that neuropsychiatric symptoms are associated with burn-out complaints and low job satisfaction. An intervention aimed at decreasing neuropsychiatric symptoms in nursing home residents with young-onset dementia might also result in less burnout complaints and job demands and improve job satisfaction in nursing staff. The aim was to evaluate the effect of the intervention on nursing staff burnout, job satisfaction and job demands. Cluster randomised controlled trial using a stepped wedge design with a total duration of 18 months, with four assessments. Thirteen young-onset dementia special care units across the Netherlands were, by means of random allocation software, assigned to three groups crossing over at different time points. All nursing staff, in total 391, were invited to participate. 305 nursing staff participated during the course of the study of whom 71 participated in all assessments. An educational program followed by a structured multidisciplinary care program aimed at the management of neuropsychiatric symptoms. The care program consists of evaluation of psychotropic drug prescription followed by detection, analysis, treatment and evaluation of treatment of neuropsychiatric symptoms. Emotional exhaustion, depersonalisation and personal accomplishment were assessed with the Utrecht Burnout Scale. Job satisfaction and job demands were assessed with subscales of the Leiden Quality of Work Questionnaire. The baseline burnout risk on emotional exhaustion and personal accomplishment was average, and low on depersonalisation. The mean scores for job satisfaction were above average and for job demands average. Linear mixed models showed that the intervention had no effect on emotional exhaustion (estimated effect −0.04, 95% confidence interval −1.25 to 1.16), depersonalisation (estimated effect 0.24, 95% confidence interval −0.26 to 0.74), personal accomplishment (estimated effect −0.82, 95% confidence interval −1.86 to 0.22) job satisfaction (estimated effect −0.40, 95% confidence interval −0.98 to 0.17) and job demands (estimated effect −0.04, 95% confidence interval −0.57 to 0.49). A significant difference was found between registered nurses and other nursing staff on emotional exhaustion and job satisfaction. Compared to other staff members, registered nurses' emotional exhaustion scores slightly increased while job satisfaction slightly decreased when using the intervention. The intervention was not effective on three dimensions of burnout, job satisfaction and job demands. Staff scored positive on the outcomes of interest before implementation of the intervention, leaving little opportunity for improvement. [ABSTRACT FROM AUTHOR]