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  1. Article: Mobility level and factors affecting mobility status in hospitalized patients admitted in single-occupancy patient rooms.

    Schafthuizen, Laura / van Dijk, Monique / van Rosmalen, Joost / Ista, Erwin

    BMC nursing

    2024  Volume 23, Issue 1, Page(s) 11

    Abstract: Background: Although stimulating patients' mobility is considered a component of fundamental nursing care, approximately 35% of hospitalized patients experience functional decline during or after hospital admission. The aim of this study is to assess ... ...

    Abstract Background: Although stimulating patients' mobility is considered a component of fundamental nursing care, approximately 35% of hospitalized patients experience functional decline during or after hospital admission. The aim of this study is to assess mobility level and to identify factors affecting mobility status in hospitalized patients admitted in single-occupancy patient rooms (SPRs) on general wards.
    Methods: Mobility level was quantified with the Johns Hopkins Highest Level of Mobility Scale (JH-HLM) and EQ-5D-3L. GENEActiv accelerometer data over 24 h were collected in a subset of patients. Data were analyzed using generalized ordinal logistic regression analysis. The STROBE reporting checklist was applied.
    Results: Wearing pajamas during daytime, having pain, admission in an isolation room, and wearing three or more medical equipment were negatively associated with mobilization level. More than half of patients (58.9%) who were able to mobilize according to the EQ-5D-3L did not achieve the highest possible level of mobility according to the JH-HLM. The subset of patients that wore an accelerometer spent most of the day in sedentary behavior (median 88.1%, IQR 85.9-93.6). The median total daily step count was 1326 (range 22-5362).
    Conclusion: We found that the majority of participating hospitalized patients staying in single-occupancy patient rooms were able to mobilize. It appeared, however, that most of the patients who are physically capable of walking, do not reach the highest possible level of mobility according to the JH-HLM scale. Nurses should take their responsibility to ensure that patients achieve the highest possible level of mobility.
    Language English
    Publishing date 2024-01-02
    Publishing country England
    Document type Journal Article
    ZDB-ID 2091496-9
    ISSN 1472-6955
    ISSN 1472-6955
    DOI 10.1186/s12912-023-01648-4
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  2. Article ; Online: Sample size calculation for clinical trials analyzed with the meta-analytic-predictive approach.

    Qi, Hongchao / Rizopoulos, Dimitris / van Rosmalen, Joost

    Research synthesis methods

    2023  Volume 14, Issue 3, Page(s) 396–413

    Abstract: The meta-analytic-predictive (MAP) approach is a Bayesian method to incorporate historical controls in new trials that aims to increase the statistical power and reduce the required sample size. Here we investigate how to calculate the sample size of the ...

    Abstract The meta-analytic-predictive (MAP) approach is a Bayesian method to incorporate historical controls in new trials that aims to increase the statistical power and reduce the required sample size. Here we investigate how to calculate the sample size of the new trial when historical data is available, and the MAP approach is used in the analysis. In previous applications of the MAP approach, the prior effective sample size (ESS) acted as a metric to quantify the number of subjects the historical information is worth. However, the validity of using the prior ESS in sample size calculation (i.e., reducing the number of randomized controls by the derived prior ESS) is questionable, because different approaches may yield different values for prior ESS. In this work, we propose a straightforward Monte Carlo approach to calculate the sample size that achieves the desired power in the new trial given available historical controls. To make full use of the available historical information to simulate the new trial data, the control parameters are not taken as a point estimate but sampled from the MAP prior. These sampled control parameters and the MAP prior based on the historical data are then used to derive the statistical power for the treatment effect and the resulting required sample size. The proposed sample size calculation approach is illustrated with real-life data sets with different outcomes from three studies. The results show that this approach to calculating the required sample size for the MAP analysis is straightforward and generic.
    MeSH term(s) Humans ; Sample Size ; Models, Statistical ; Bayes Theorem ; Monte Carlo Method ; Research Design ; Computer Simulation
    Language English
    Publishing date 2023-01-14
    Publishing country England
    Document type Meta-Analysis ; Journal Article
    ZDB-ID 2548499-0
    ISSN 1759-2887 ; 1759-2879
    ISSN (online) 1759-2887
    ISSN 1759-2879
    DOI 10.1002/jrsm.1618
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  3. Article ; Online: A Simple Cost-Effectiveness Model of Screening: An Open-Source Teaching and Research Tool Coded in R.

    Lin, Yi-Shu / O'Mahony, James F / van Rosmalen, Joost

    PharmacoEconomics - open

    2023  Volume 7, Issue 4, Page(s) 507–523

    Abstract: Applied cost-effectiveness analysis models are an important tool for assessing health and economic effects of healthcare interventions but are not best suited for illustrating methods. Our objective is to provide a simple, open-source model for the ... ...

    Abstract Applied cost-effectiveness analysis models are an important tool for assessing health and economic effects of healthcare interventions but are not best suited for illustrating methods. Our objective is to provide a simple, open-source model for the simulation of disease-screening cost-effectiveness for teaching and research purposes. We introduce our model and provide an initial application to examine changes to the efficiency frontier as input parameters vary and to demonstrate face validity. We described a vectorised, discrete-event simulation of screening in R with an Excel interface to define parameters and inspect principal results. An R Shiny app permits dynamic interpretation of simulation outputs. An example with 8161 screening strategies illustrates the cost and effectiveness of varying the disease sojourn time, treatment effectiveness, and test performance characteristics and costs on screening policies. Many of our findings are intuitive and straightforward, such as a reduction in screening costs leading to decreased overall costs and improved cost-effectiveness. Others are less obvious and depend on whether we consider gross outcomes or those net to no screening. For instance, enhanced treatment of symptomatic disease increases gross effectiveness, but reduces the net effectiveness and cost-effectiveness of screening. A lengthening of the preclinical sojourn time has ambiguous effects relative to no screening, as cost-effectiveness improves for some strategies but deteriorates for others. Our simple model offers an accessible platform for methods research and teaching. We hope it will serve as a public good and promote an intuitive understanding of the cost-effectiveness of screening.
    Language English
    Publishing date 2023-06-01
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2874287-4
    ISSN 2509-4254 ; 2509-4262
    ISSN (online) 2509-4254
    ISSN 2509-4262
    DOI 10.1007/s41669-023-00414-1
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  4. Article ; Online: Incorporating historical control information in ANCOVA models using the meta-analytic-predictive approach.

    Qi, Hongchao / Rizopoulos, Dimitris / van Rosmalen, Joost

    Research synthesis methods

    2022  Volume 13, Issue 6, Page(s) 681–696

    Abstract: The meta-analytic-predictive (MAP) approach is a Bayesian meta-analytic method to synthesize and incorporate information from historical controls in the analysis of a new trial. Classically, only a single parameter, typically the intercept or rate, is ... ...

    Abstract The meta-analytic-predictive (MAP) approach is a Bayesian meta-analytic method to synthesize and incorporate information from historical controls in the analysis of a new trial. Classically, only a single parameter, typically the intercept or rate, is assumed to vary across studies, which may not be realistic in more complex models. Analysis of covariance (ANCOVA) is often used to analyze trials with a pretest-posttest design, where both the intercept and the baseline effect (coefficient of the outcome at baseline) affect the estimated treatment effect. We extended the MAP approach to ANCOVA, to allow for variation in the intercept and the baseline effect across studies, and possibly also correlation between these parameters. The method was illustrated using data from the Alzheimer's Disease Cooperative Study (ADCS) and assessed with a simulation study. In the ADCS data, the proposed multivariate MAP approach yielded a prior effective sample size of 79 and 58 for the intercept and the baseline effect respectively and reduced the posterior standard deviation of the treatment effect by 12.6%. The result was robust to the choice of prior for the between-study variation. In the simulations, the proposed approach yielded power gains with a good control of the type I error rate. Ignoring the between-study correlation of the parameters or assuming no variation in the baseline effect generally led to less power gain. In conclusion, the MAP approach can be extended to a multivariate version for ANCOVA, which may improve the estimation of the treatment effect.
    MeSH term(s) Bayes Theorem ; Models, Statistical ; Sample Size ; Research Design ; Computer Simulation
    Language English
    Publishing date 2022-04-26
    Publishing country England
    Document type Meta-Analysis ; Journal Article
    ZDB-ID 2548499-0
    ISSN 1759-2887 ; 1759-2879
    ISSN (online) 1759-2887
    ISSN 1759-2879
    DOI 10.1002/jrsm.1561
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  5. Article ; Online: Incorporating historical controls in clinical trials with longitudinal outcomes using the modified power prior.

    Qi, Hongchao / Rizopoulos, Dimitris / Lesaffre, Emmanuel / van Rosmalen, Joost

    Pharmaceutical statistics

    2022  Volume 21, Issue 5, Page(s) 818–834

    Abstract: Several dynamic borrowing methods, such as the modified power prior (MPP), the commensurate prior, have been proposed to increase statistical power and reduce the required sample size in clinical trials where comparable historical controls are available. ...

    Abstract Several dynamic borrowing methods, such as the modified power prior (MPP), the commensurate prior, have been proposed to increase statistical power and reduce the required sample size in clinical trials where comparable historical controls are available. Most methods have focused on cross-sectional endpoints, and appropriate methodology for longitudinal outcomes is lacking. In this study, we extend the MPP to the linear mixed model (LMM). An important question is whether the MPP should use the conditional version of the LMM (given the random effects) or the marginal version (averaged over the distribution of the random effects), which we refer to as the conditional MPP and the marginal MPP, respectively. We evaluated the MPP for one historical control arm via a simulation study and an analysis of the data of Alzheimer's Disease Cooperative Study (ADCS) with the commensurate prior as the comparator. The conditional MPP led to inflated type I error rate when there existed moderate or high between-study heterogeneity. The marginal MPP and the commensurate prior yielded a power gain (3.6%-10.4% vs. 0.6%-4.6%) with the type I error rates close to 5% (5.2%-6.2% vs. 3.8%-6.2%) when the between-study heterogeneity is not excessively high. For the ADCS data, all the borrowing methods improved the precision of estimates and provided the same clinical conclusions. The marginal MPP and the commensurate prior are useful for borrowing historical controls in longitudinal data analysis, while the conditional MPP is not recommended due to inflated type I error rates.
    MeSH term(s) Bayes Theorem ; Computer Simulation ; Cross-Sectional Studies ; Humans ; Linear Models ; Models, Statistical ; Research Design ; Sample Size
    Language English
    Publishing date 2022-02-06
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 2083706-9
    ISSN 1539-1612 ; 1539-1604
    ISSN (online) 1539-1612
    ISSN 1539-1604
    DOI 10.1002/pst.2195
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  6. Article: Reasons Patients With Primary Progressive Multiple Sclerosis Contact Their Specialist Nurses.

    van den Berg, Rosaline / Blok, Katelijn / Tebayna, Nura / van Dijk, Monique / van Rosmalen, Joost / de Beukelaar, Janet

    International journal of MS care

    2024  Volume 26, Issue 1, Page(s) 30–35

    Abstract: Background: Questions asked by patients with primary progressive multiple sclerosis (PPMS) during patient-initiated MS nurse consultations may contain salient information that can help health care providers understand their needs, which, in turn, can ... ...

    Abstract Background: Questions asked by patients with primary progressive multiple sclerosis (PPMS) during patient-initiated MS nurse consultations may contain salient information that can help health care providers understand their needs, which, in turn, can help tailor counseling and treatment.
    Methods: Records of all patients with PPMS visiting the MS center of a large teaching hospital in the Netherlands between January 2007 and January 2021 were studied retrospectively. Number and type (scheduled or patient initiated) of MS nurse consultations, reasons for consultations (in prespecified categories), and frequency of subsequent referrals were registered. Association between factors (living with partner, Expanded Disability Status Scale score, comorbidities, age, sex) and number of patient-initiated consultations was studied using negative binomial regression analysis.
    Results: In total, 98 patients with PPMS were included, with 720 MS nurse consultations during follow-up (median duration, 8.1 years), of which 274 (38%) were patient initiated. Patients had a broad spectrum of reasons to contact MS nurses. The most common categories were treatment (36%) and micturition and defecation (31%). Patients living without a partner (incidence rate ratio, 2.340; 95% CI, 1.057-5.178) and male patients (incidence rate ratio, 1.890; 95% CI, 0.925-3.861) consulted MS nurses more frequently. The MS nurses made 146 referrals (20% of all contacts); 59 were after patient-initiated consultation (22%). The most frequent referrals were to neurologists, urologists, and rehabilitation specialists.
    Conclusions: Multiple sclerosis nurses have a pivotal role in PPMS care, especially for patients living without a partner and male patients. Recurring questions about (new) treatment options illustrate the pressing need for highly effective treatment. Micturition and defecation problems are also a considerable concern and warrant close monitoring.
    Language English
    Publishing date 2024-01-05
    Publishing country United States
    Document type Journal Article
    ISSN 1537-2073
    ISSN 1537-2073
    DOI 10.7224/1537-2073.2022-056
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  7. Article ; Online: ASO Author Reflections: What Can Prediction Models for Upstaging of DCIS Diagnosed on Biopsy Tell Us About DCIS Surveillance Trials?

    Westenend, Pieter / Meurs, Claudia / van Bekkum, Sara / van Rosmalen, Joost / Menke-Pluijmers, Marian / Siesling, Sabine

    Annals of surgical oncology

    2024  Volume 31, Issue 4, Page(s) 2272–2273

    MeSH term(s) Humans ; Carcinoma, Intraductal, Noninfiltrating/diagnosis ; Carcinoma, Intraductal, Noninfiltrating/surgery ; Carcinoma, Intraductal, Noninfiltrating/pathology ; Sentinel Lymph Node Biopsy ; Carcinoma, Ductal, Breast/pathology ; Retrospective Studies
    Language English
    Publishing date 2024-01-25
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1200469-8
    ISSN 1534-4681 ; 1068-9265
    ISSN (online) 1534-4681
    ISSN 1068-9265
    DOI 10.1245/s10434-024-14964-z
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  8. Article ; Online: The power prior with multiple historical controls for the linear regression model.

    Banbeta, Akalu / Lesaffre, Emmanuel / van Rosmalen, Joost

    Pharmaceutical statistics

    2021  Volume 21, Issue 2, Page(s) 418–438

    Abstract: Combining historical control data with current control data may reduce the necessary study size of a clinical trial. However, this only applies when the historical control data are similar enough to the current control data. Several Bayesian approaches ... ...

    Abstract Combining historical control data with current control data may reduce the necessary study size of a clinical trial. However, this only applies when the historical control data are similar enough to the current control data. Several Bayesian approaches for incorporating historical data in a dynamic way have been proposed, such as the meta-analytic-predictive (MAP) prior and the modified power prior (MPP). Here we discuss the generalization of the MPP approach for multiple historical control groups for the linear regression model. This approach is useful when the controls differ more than in a random way, but become again (approximately) exchangeable conditional on covariates. The proposed approach builds on the approach previously developed for binary outcomes by some of the current authors. Two MPP approaches have been developed with multiple controls. The first approach assumes independent powers, while in the second approach the powers have a hierarchical structure. We conducted several simulation studies to investigate the frequentist characteristics of borrowing methods and analyze a real-life data set. When there is between-study variation in the slopes of the model or in the covariate distributions, the MPP approach achieves approximately nominal type I error rates and greater power than the MAP prior, provided that the covariates are included in the model. When the intercepts vary, the MPP yields a slightly inflated type I error rate, whereas the MAP does not. We conclude that our approach is a worthy competitor to the MAP approach for the linear regression case.
    MeSH term(s) Bayes Theorem ; Computer Simulation ; Humans ; Linear Models
    Language English
    Publishing date 2021-12-01
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 2083706-9
    ISSN 1539-1612 ; 1539-1604
    ISSN (online) 1539-1612
    ISSN 1539-1604
    DOI 10.1002/pst.2178
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  9. Article ; Online: Outcome of early-onset fetal growth restriction with or without abnormal umbilical artery Doppler flow.

    Gairabekova, Diana / van Rosmalen, Joost / Duvekot, Johannes J

    Acta obstetricia et gynecologica Scandinavica

    2021  Volume 100, Issue 8, Page(s) 1430–1438

    Abstract: Introduction: Early-onset fetal growth restriction is a pregnancy complication often coinciding with abnormal Doppler flow in the umbilical artery. Absent or reversed end-diastolic flow in the umbilical artery is associated with adverse perinatal ... ...

    Abstract Introduction: Early-onset fetal growth restriction is a pregnancy complication often coinciding with abnormal Doppler flow in the umbilical artery. Absent or reversed end-diastolic flow in the umbilical artery is associated with adverse perinatal outcome. As the optimal management of this condition is unclear, the objective of this study was to analyze the time interval from admission to delivery of pregnancies with early-onset fetal growth restriction, while pursuing a policy of postponing delivery unless active management of labor would be required because of fetal distress or maternal condition. We also assessed short- and long-term perinatal outcome.
    Material and methods: In this historical cohort study, all pregnant women with singleton pregnancies, admitted during 2004-2015 with early-onset fetal growth restriction were included. Pregnancies with absent or reversed end-diastolic flow (AREDF) were compared with pregnancies with a positive end-diastolic Doppler flow (PEDF). Time until delivery was determined and perinatal outcome was assessed for both groups.
    Results: In our study, 111 women were allocated to the PEDF group and 109 to the AREDF group. In the AREDF group, fetal distress was more often an indication for delivery, in comparison with the PEDF group (p = .004). Median time until delivery in patients admitted between 26 and 28 weeks' gestation was 6+5 weeks in the PEDF group and 1+4 weeks in the AREDF group (p = .001). No statistically significant difference was found between the Doppler groups in the composite adverse neonatal outcome, which includes at least one of the following outcomes: infant respiratory distress syndrome, sepsis, bronchopulmonary dysplasia, necrotizing enterocolitis, intraventricular hemorrhage >grade 2, periventricular leukomalacia and perinatal death (p = .63).
    Conclusions: In this study, comprising pregnancies with early-onset fetal growth restriction, fetal distress was observed more frequently in the AREDF group with the consequence of delivery at an earlier stage of gestation, compared with the PEDF group. AREDF was not associated with increased perinatal morbidity and mortality compared with PEDF.
    MeSH term(s) Adult ; Blood Flow Velocity ; Female ; Fetal Growth Retardation/diagnostic imaging ; Fetal Growth Retardation/physiopathology ; Humans ; Pregnancy ; Pregnancy Outcome ; Pulsatile Flow ; Ultrasonography, Doppler ; Ultrasonography, Prenatal ; Umbilical Arteries/physiopathology ; Young Adult
    Language English
    Publishing date 2021-03-29
    Publishing country United States
    Document type Comparative Study ; Journal Article
    ZDB-ID 80019-3
    ISSN 1600-0412 ; 0001-6349
    ISSN (online) 1600-0412
    ISSN 0001-6349
    DOI 10.1111/aogs.14142
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  10. Article ; Online: Implementation of a nursing oral health care protocol in a university teaching hospital: A cluster-randomized stepped-wedge design.

    Schafthuizen, Laura / Spruit-Bentvelzen, Lotte / van Dijk, Monique / van Rosmalen, Joost / Ista, Erwin

    International journal of dental hygiene

    2023  

    Abstract: Introduction: Providing oral care is an essential part of basic nursing care but receives little priority in daily practice, with a risk of adverse events. Also, nurses report many barriers to adequate provision of oral care, such as time restraints, ... ...

    Abstract Introduction: Providing oral care is an essential part of basic nursing care but receives little priority in daily practice, with a risk of adverse events. Also, nurses report many barriers to adequate provision of oral care, such as time restraints, insufficient materials, fear of causing pain, lack of knowledge and a negative attitude towards providing oral care.
    Methods: We performed a cluster-randomized, stepped-wedge study to explore the effect of the the implementation of a new nursing evidence-based oral care protocol on nurses' knowledge, attitude and protocol adherence. The study population included both nursing students, graduated nurses and patients in selected wards. The implementation strategy included oral and written information, instruction videos and reminders. Nurses' knowledge and attitude towards oral care were assessed at baseline and after the implementation of the protocol with a validated 47-item questionnaire with a score range of 0-100. Secondarily, nurses' protocol adherence to teeth brushing, measured in Activities of Daily Living (ADL) dependent patients, was evaluated. The Standards for Reporting Implementation Studies (StaRI) Statement was used.
    Results: At baseline, the questionnaire was completed by 226 nurses; after implementation by 283. Knowledge had significantly improved from 68.8 to 72.3. Nurses' attitude improved not significantly. Protocol adherence was assessed in 73 ADL-dependent patients at baseline, in 51 after implementation. Adherence to teeth brushing significantly decreased in patients with permanent teeth. Also, adherence to both teeth brushing and usage of soap decreased in patients with (partial) dentures.
    Conclusion: Nurses' knowledge and attitude of oral care increased somewhat after the implementation of a new nursing evidence-based protocol. After implementation, there was an unexplained decreased adherence to oral care in ADL-dependent patients.
    Language English
    Publishing date 2023-09-18
    Publishing country England
    Document type Journal Article
    ZDB-ID 2252118-5
    ISSN 1601-5037 ; 1601-5029
    ISSN (online) 1601-5037
    ISSN 1601-5029
    DOI 10.1111/idh.12748
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