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1.
Arch Orthop Trauma Surg ; 143(8): 4933-4941, 2023 Aug.
Article in English | MEDLINE | ID: mdl-36646943

ABSTRACT

INTRODUCTION: Nosocomial pneumonia has poor prognosis in hospitalized trauma patients. Croce et al. published a model to predict post-traumatic ventilator-associated pneumonia, which achieved high discrimination and reasonable sensitivity. We aimed to externally validate Croce's model to predict nosocomial pneumonia in patients admitted to a Dutch level-1 trauma center. MATERIALS AND METHODS: This retrospective study included all trauma patients (≥ 16y) admitted for > 24 h to our level-1 trauma center in 2017. Exclusion criteria were pneumonia or antibiotic treatment upon hospital admission, treatment elsewhere > 24 h, or death < 48 h. Croce's model used eight clinical variables-on trauma severity and treatment, available in the emergency department-to predict nosocomial pneumonia risk. The model's predictive performance was assessed through discrimination and calibration before and after re-estimating the model's coefficients. In sensitivity analysis, the model was updated using Ridge regression. RESULTS: 809 Patients were included (median age 51y, 67% male, 97% blunt trauma), of whom 86 (11%) developed nosocomial pneumonia. Pneumonia patients were older, more severely injured, and underwent more emergent interventions. Croce's model showed good discrimination (AUC 0.83, 95% CI 0.79-0.87), yet predicted probabilities were too low (mean predicted risk 6.4%), and calibration was suboptimal (calibration slope 0.63). After full model recalibration, discrimination (AUC 0.84, 95% CI 0.80-0.88) and calibration improved. Adding age to the model increased the AUC to 0.87 (95% CI 0.84-0.91). Prediction parameters were similar after the models were updated using Ridge regression. CONCLUSION: The externally validated and intercept-recalibrated models show good discrimination and have the potential to predict nosocomial pneumonia. At this time, clinicians could apply these models to identify high-risk patients, increase patient monitoring, and initiate preventative measures. Recalibration of Croce's model improved the predictive performance (discrimination and calibration). The recalibrated model provides a further basis for nosocomial pneumonia prediction in level-1 trauma patients. Several models are accessible via an online tool. LEVEL OF EVIDENCE: Level III, Prognostic/Epidemiological Study.


Subject(s)
Cross Infection , Healthcare-Associated Pneumonia , Pneumonia , Humans , Male , Middle Aged , Female , Retrospective Studies , Cross Infection/diagnosis , Cross Infection/etiology , Prognosis , Healthcare-Associated Pneumonia/diagnosis , Healthcare-Associated Pneumonia/epidemiology , Healthcare-Associated Pneumonia/etiology , Pneumonia/epidemiology , Pneumonia/etiology
2.
Stat Med ; 38(27): 5182-5196, 2019 11 30.
Article in English | MEDLINE | ID: mdl-31478240

ABSTRACT

In randomised trials, continuous endpoints are often measured with some degree of error. This study explores the impact of ignoring measurement error and proposes methods to improve statistical inference in the presence of measurement error. Three main types of measurement error in continuous endpoints are considered: classical, systematic, and differential. For each measurement error type, a corrected effect estimator is proposed. The corrected estimators and several methods for confidence interval estimation are tested in a simulation study. These methods combine information about error-prone and error-free measurements of the endpoint in individuals not included in the trial (external calibration sample). We show that, if measurement error in continuous endpoints is ignored, the treatment effect estimator is unbiased when measurement error is classical, while Type-II error is increased at a given sample size. Conversely, the estimator can be substantially biased when measurement error is systematic or differential. In those cases, bias can largely be prevented and inferences improved upon using information from an external calibration sample, of which the required sample size increases as the strength of the association between the error-prone and error-free endpoint decreases. Measurement error correction using already a small (external) calibration sample is shown to improve inferences and should be considered in trials with error-prone endpoints. Implementation of the proposed correction methods is accommodated by a new software package for R.


Subject(s)
Endpoint Determination , Randomized Controlled Trials as Topic/methods , Scientific Experimental Error , Computer Simulation , Data Interpretation, Statistical , Endpoint Determination/methods , Endpoint Determination/statistics & numerical data , Hemoglobins/analysis , Humans , Randomized Controlled Trials as Topic/standards , Sample Size , Scientific Experimental Error/statistics & numerical data
3.
Stat Med ; 38(18): 3444-3459, 2019 08 15.
Article in English | MEDLINE | ID: mdl-31148207

ABSTRACT

It is widely acknowledged that the predictive performance of clinical prediction models should be studied in patients that were not part of the data in which the model was derived. Out-of-sample performance can be hampered when predictors are measured differently at derivation and external validation. This may occur, for instance, when predictors are measured using different measurement protocols or when tests are produced by different manufacturers. Although such heterogeneity in predictor measurement between derivation and validation data is common, the impact on the out-of-sample performance is not well studied. Using analytical and simulation approaches, we examined out-of-sample performance of prediction models under various scenarios of heterogeneous predictor measurement. These scenarios were defined and clarified using an established taxonomy of measurement error models. The results of our simulations indicate that predictor measurement heterogeneity can induce miscalibration of prediction and affects discrimination and overall predictive accuracy, to extents that the prediction model may no longer be considered clinically useful. The measurement error taxonomy was found to be helpful in identifying and predicting effects of heterogeneous predictor measurements between settings of prediction model derivation and validation. Our work indicates that homogeneity of measurement strategies across settings is of paramount importance in prediction research.


Subject(s)
Models, Statistical , Biostatistics , Computer Simulation , Humans , Logistic Models , Monte Carlo Method , Predictive Value of Tests , Validation Studies as Topic
5.
Br J Surg ; 103(8): 995-1002, 2016 07.
Article in English | MEDLINE | ID: mdl-27059152

ABSTRACT

BACKGROUND: Long-term survival is similar after open or endovascular repair of abdominal aortic aneurysm. Few data exist on the effect of either procedure on long-term health-related quality of life (HRQoL) and health status. METHODS: Patients enrolled in a multicentre randomized clinical trial (DREAM trial; 2000-2003) in Europe of open repair versus endovascular repair (EVAR) of abdominal aortic aneurysm were asked to complete questionnaires on health status and HRQoL. HRQoL scores were assessed at baseline and at 13 time points thereafter, using generic tools, the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36®) and EuroQol 5D (EQ-5D™). Physical (PCS) and mental component summary scores were also calculated. Follow-up was 5 years. RESULTS: Some 332 of 351 patients enrolled in the trial returned questionnaires. More than 70 per cent of questionnaires were returned at each time point. Both surgical interventions had a short-term negative effect on HRQoL and health status. This was less severe in the EVAR group than in the open repair group. In the longer term the physical domains of SF-36® favoured open repair: mean difference in PCS score between open repair and EVAR -1·98 (95 per cent c.i. -3·56 to -0·41). EQ-5D™ descriptive and EQ-5D™ visual analogue scale scores for open repair were also superior to those for EVAR after the initial 6-week interval: mean difference -0·06 (-0·10 to -0·02) and -4·09 (-6·91 to -1·27) respectively. CONCLUSION: In this study EVAR appeared to be associated with less severe disruption to HRQoL and health status in the short term. However, during longer-term follow-up to 5 years, patients receiving open repair appeared to have improved quality of life and health status.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Endovascular Procedures , Quality of Life , Aged , Belgium , Female , Follow-Up Studies , Health Status , Humans , Male , Netherlands , Surveys and Questionnaires , Visual Analog Scale
6.
Pharmacoepidemiol Drug Saf ; 25(4): 355-62, 2016 Apr.
Article in English | MEDLINE | ID: mdl-26877168

ABSTRACT

BACKGROUND AND OBJECTIVE: Applying results from clinical studies to individual patients can be a difficult process. Using the concept of treatment effect modification (also referred to as interaction), defined as a difference in treatment response between patient groups, we discuss whether and how treatment effects can be tailored to better meet patients' needs. RESULTS: First we argue that contrary to how most studies are designed, treatment effect modification should be expected. Second, given this expected heterogeneity, a small number of clinically relevant subgroups should be a priori selected, depending on the expected magnitude of effect modification, and prevalence of the patient type. Third, by defining generalizability as the absence of treatment effect modification we show that generalizability can be evaluated within the usual statistical framework of equivalence testing. Fourth, when equivalence cannot be confirmed, we address the need for further analyses and studies tailoring treatment towards groups of patients with similar response to treatment. Fifth, we argue that to properly frame, the entire body of evidence on effect modification should be quantified in a prior probability.


Subject(s)
Clinical Trials as Topic/methods , Precision Medicine/methods , Research Design , Health Services Needs and Demand , Humans , Randomized Controlled Trials as Topic/methods
7.
BJOG ; 122(1): 27-37, 2015 Jan.
Article in English | MEDLINE | ID: mdl-25145491

ABSTRACT

BACKGROUND: In twin pregnancies, the rates of adverse perinatal outcome and subsequent long-term morbidity are substantial, and mainly result from preterm birth (PTB). OBJECTIVES: To assess the effectiveness of progestogen treatment in the prevention of neonatal morbidity or PTB in twin pregnancies using individual participant data meta-analysis (IPDMA). SEARCH STRATEGY: We searched international scientific databases, trial registration websites, and references of identified articles. SELECTION CRITERIA: Randomised clinical trials (RCTs) of 17-hydroxyprogesterone caproate (17Pc) or vaginally administered natural progesterone, compared with placebo or no treatment. DATA COLLECTION AND ANALYSIS: Investigators of identified RCTs were asked to share their IPD. The primary outcome was a composite of perinatal mortality and severe neonatal morbidity. Prespecified subgroup analyses were performed for chorionicity, cervical length, and prior spontaneous PTB. MAIN RESULTS: Thirteen trials included 3768 women and their 7536 babies. Neither 17Pc nor vaginal progesterone reduced the incidence of adverse perinatal outcome (17Pc relative risk, RR 1.1; 95% confidence interval, 95% CI 0.97-1.4, vaginal progesterone RR 0.97; 95% CI 0.77-1.2). In a subgroup of women with a cervical length of ≤25 mm, vaginal progesterone reduced adverse perinatal outcome when cervical length was measured at randomisation (15/56 versus 22/60; RR 0.57; 95% CI 0.47-0.70) or before 24 weeks of gestation (14/52 versus 21/56; RR 0.56; 95% CI 0.42-0.75). AUTHOR'S CONCLUSIONS: In unselected women with an uncomplicated twin gestation, treatment with progestogens (intramuscular 17Pc or vaginal natural progesterone) does not improve perinatal outcome. Vaginal progesterone may be effective in the reduction of adverse perinatal outcome in women with a cervical length of ≤25 mm; however, further research is warranted to confirm this finding.


Subject(s)
Hydroxyprogesterones/therapeutic use , Infant, Newborn, Diseases/prevention & control , Perinatal Death/prevention & control , Pregnancy, Twin , Premature Birth/prevention & control , Progesterone/therapeutic use , Progestins/therapeutic use , 17 alpha-Hydroxyprogesterone Caproate , Administration, Intravaginal , Adult , Bronchopulmonary Dysplasia/prevention & control , Cerebral Hemorrhage/prevention & control , Cervical Length Measurement , Cervix Uteri/diagnostic imaging , Enterocolitis, Necrotizing/prevention & control , Female , Humans , Infant, Newborn , Pregnancy , Respiratory Distress Syndrome, Newborn/prevention & control , Treatment Outcome
8.
Ann Nutr Metab ; 65(2-3): 139-48, 2014.
Article in English | MEDLINE | ID: mdl-25413652

ABSTRACT

BACKGROUND: Estimated effects of breast-feeding on childhood health vary between studies, possibly due to confounding by baseline maternal and child characteristics. Possible time-dependent confounding has received little consideration. Our aim was to evaluate the impact of such confounding. METHODS: We estimated the relationship between cumulative exclusive breast-feeding up to 6 months and wheezing, rash and body mass index (BMI) at 12 months [in the Whistler cohort (n = 494) and PROBIT (n = 11,463)], and wheezing, rash, asthma, hay fever, eczema, allergy and BMI at age 6.5 years (PROBIT). We adjusted for time-dependent confounding by weight, length, rash, respiratory illness and day care attendance using marginal structural models (MSMs). RESULTS: Weight and day care attendance appeared potential time-dependent confounders, since these predicted breast-feeding status and were influenced by previous breast-feeding. However, adjustment for time-dependent confounders did not markedly change the estimated associations. For example, in PROBIT the adjusted increase in BMI at 12 months per 1-month increase in exclusive breast-feeding was 0.04 (95% CI -0.09 to 0.01) using logistic regression and -0.06 (95% CI -0.11 to -0.01) using MSM. In Whistler, these estimates were each -0.05 (95% CI -0.10 to 0.00). CONCLUSIONS: In two cohort studies, there was little evidence of time-dependent confounding by weight, length, rash, respiratory illness or day care attendance of the effects of breast-feeding on early childhood health.


Subject(s)
Breast Feeding , Asthma/epidemiology , Body Mass Index , Body Weight , Child , Child, Preschool , Cluster Analysis , Exanthema/epidemiology , Female , Follow-Up Studies , Humans , Hypersensitivity/epidemiology , Infant , Logistic Models , Male , Respiratory Sounds , Rhinitis, Allergic, Seasonal/epidemiology , Risk Factors
9.
Article in English | MEDLINE | ID: mdl-39307850

ABSTRACT

PURPOSE: This study aimed to investigate practice variation in non-operative treatment methods and immobilisation duration for metacarpal fractures, and to evaluate patient-reported outcomes. METHODS: Conducted in 12 Dutch hospitals over three months in 2020, this study included adult patients with non-operatively treated solitary metacarpal fractures. Fractures were classified into intra-articular base, extra-articular base, shaft, neck, and intra-articular head fractures. The treatment methods (functional treatment allowing digit mobilisation or immobilisation) and immobilisation duration were assessed. Patient-reported outcomes were evaluated using the Michigan Hand Outcomes Questionnaire (MHQ) at three months post-trauma. RESULTS: Of 389 included patients, shaft fractures were most common (n = 150, 39%), with 93% immobilised, followed by fifth metacarpal neck fractures (n = 93, 24%), with 75% immobilised. Immobilisation rates for fifth metacarpal neck fractures varied between hospitals, ranging from 29% (95% CI 0.10-0.58) to 100% (95% CI 0.78-1.00). The median immobilisation duration for all fractures was 23 days (IQR: 20-28), and hospital setting was independently associated with this duration. Patients with metacarpal shaft fractures immobilised for less than 21 days had higher MHQ scores compared to those immobilised for 21 days or more (median (IQR) 83 (76-100) versus 71 (57-89), p = 0.026). CONCLUSIONS: The results showed practice variation in the treatment of metacarpal fractures, especially in the treatment of fifth MC neck fractures, with some hospitals following the Dutch guideline that advocates functional treatment while others did not. There are suggestions that prolonged immobilisation of metacarpal shaft fractures may lead to a worse MHQ score. These findings underscore the need for adherence to treatment protocols and emphasize functional treatment to potentially improve patient outcomes and cost-effectiveness.

10.
Article in English | MEDLINE | ID: mdl-39269646

ABSTRACT

PURPOSE: Ulnar styloid process (USP) fractures are present in 40-65% of all distal radius fractures (DRFs). USP base fractures can be associated with distal radioulnar joint (DRUJ) instability and ulnar sided wrist pain and are treated by conservative management and surgical fixation, without consensus. This systematic review and meta-analysis compares operative to non-operative treatment of concomitant ulnar styloid base fractures in patients with distal radius fractures. METHODS: PubMed/Medline/Embase/CENTRAL databases were searched identifying RCTs and comparative observational studies. Effect estimates were extracted and pooled using random effect models to account for heterogeneity across studies. Results were presented as (standardized) mean differences (SMD or MD) or odds ratios (OR) and corresponding 95% confidence intervals (95%CI). RESULTS: Two RCTs (161 patients) and three observational studies (175 patients) were included. Tension band wiring was used for surgically treated USP fractures. Results were comparable across the different study designs and hence pooled across studies. Non-surgically treated patients had better wrist function at 6 months (SMD 0.57, 95%CI 0.30; 0.90, I2 = 0%). After 12 months there was no observed difference (MD 2.31, 95%CI -2.57; 7.19, I2 = 91%). Fewer patients had USP non-unions in the operative group (OR 0.08, 95%CI 0.04; 0.18, I2 = 0%). More patients suffered complications in the operative group (OR 14.3; 95%CI 1.08; 188, I2 = 89%). CONCLUSION: Routinely fixating USP base fractures as standard of care is not indicated. Surgery may be considered in selective cases (e.g. persistent DRUJ instability during ballottement test after fixation of the radius).

11.
R Soc Open Sci ; 11(1): 231003, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38234442

ABSTRACT

Results of simulation studies evaluating the performance of statistical methods can have a major impact on the way empirical research is implemented. However, so far there is limited evidence of the replicability of simulation studies. Eight highly cited statistical simulation studies were selected, and their replicability was assessed by teams of replicators with formal training in quantitative methodology. The teams used information in the original publications to write simulation code with the aim of replicating the results. The primary outcome was to determine the feasibility of replicability based on reported information in the original publications and supplementary materials. Replicasility varied greatly: some original studies provided detailed information leading to almost perfect replication of results, whereas other studies did not provide enough information to implement any of the reported simulations. Factors facilitating replication included availability of code, detailed reporting or visualization of data-generating procedures and methods, and replicator expertise. Replicability of statistical simulation studies was mainly impeded by lack of information and sustainability of information sources. We encourage researchers publishing simulation studies to transparently report all relevant implementation details either in the research paper itself or in easily accessible supplementary material and to make their simulation code publicly available using permanent links.

12.
Eur J Trauma Emerg Surg ; 49(3): 1383-1392, 2023 Jun.
Article in English | MEDLINE | ID: mdl-36856781

ABSTRACT

INTRODUCTION: Anterior shoulder dislocations are commonly seen in the emergency department for which several closed reduction techniques exist. The aim of this systematic review is to identify the most successful principle of closed reduction techniques for an acute anterior shoulder dislocation in the emergency department without the use of sedation or intra-articular lidocaine injection. METHODS: A literature search was conducted up to 15-08-2022 in the electronic databases of PubMed, Embase and CENTRAL for randomized and observational studies comparing two or more closed reduction techniques for anterior shoulder dislocations. Included techniques were grouped based on their main operating mechanism resulting in a traction-countertraction (TCT), leverage and biomechanical reduction technique (BRT) group. The primary outcome was success rate and secondary outcomes were reduction time and endured pain scores. Meta-analyses were conducted between reduction groups and for the primary outcome a network meta-analysis was performed. RESULTS: A total of 3118 articles were screened on title and abstract, of which 9 were included, with a total of 987 patients. Success rates were 0.80 (95% CI 0.74; 0.85), 0.81 (95% CI 0.63; 0.92) and 0.80 (95% CI 0.56; 0.93) for BRT, leverage and TCT, respectively. No differences in success rates were observed between the three separate reduction groups. In the network meta-analysis, similar yet more precise effect estimates were found. However, in a post hoc analysis the BRT group was more successful than the combined leverage and TCT group with a relative risk of 1.33 (95% CI 1.19, 1.48). CONCLUSION: All included techniques showed good results with regard to success of reduction. The BRT might be the preferred technique for the reduction of an anterior shoulder dislocation, as patients experience the least pain and it results in the fastest reduction.


Subject(s)
Shoulder Dislocation , Humans , Shoulder Dislocation/therapy , Lidocaine , Pain , Injections, Intra-Articular
13.
Injury ; 54(10): 110823, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37217400

ABSTRACT

Geriatric patients often present to the hospital in acute surgical settings. In these settings, shared decision-making as equal partners can be challenging. Surgeons should recognize that geriatric patients, and frail patients in particular, may sometimes benefit from de-escalation of care in a palliative setting rather than curative treatment. To provide more person-centred care, better strategies for improved shared decision-making need to be developed and implemented in clinical practice. A shift in thinking from a disease-oriented paradigm to a patient-goal-oriented paradigm is required to provide better person-centred care for older patients. We may greatly improve the collaboration with patients if we move parts of the decision-making process to the pre-acute phase. In the pre-acute phase appointing legal representatives, having goals of care conversations, and advance care planning can help give physicians an idea of what is important to the patient in acute settings. When making decisions as equal partners is not possible, a greater degree of physician responsibility may be appropriate. Physicians should tailor the "sharedness" of the decision-making process to the needs of the patient and their family.


Subject(s)
Decision Making , Surgeons , Humans , Aged , Patient Participation , Hospitals , Communication
14.
Eur J Trauma Emerg Surg ; 49(4): 1619-1626, 2023 Aug.
Article in English | MEDLINE | ID: mdl-36624221

ABSTRACT

Over the last decades, the Dutch trauma care have seen major improvements. To assess the performance of the Dutch trauma system, in 2007, the Dutch Nationwide Trauma Registry (DNTR) was established, which developed into rich source of information for quality assessment, quality improvement of the trauma system, and for research purposes. The DNTR is one of the most comprehensive trauma registries in the world as it includes 100% of all trauma patients admitted to the hospital through the emergency department. This inclusive trauma registry has shown its benefit over less inclusive systems; however, it comes with a high workload for high-quality data collection and thus more expenses. The comprehensive prospectively collected data in the DNTR allows multiple types of studies to be performed. Recent changes in legislation allow the DNTR to include the citizen service numbers, which enables new possibilities and eases patient follow-up. However, in order to maximally exploit the possibilities of the DNTR, further development is required, for example, regarding data quality improvement and routine incorporation of health-related quality of life questionnaires. This would improve the quality assessment and scientific output from the DNTR. Finally, the DNTR and all other (European) trauma registries should strive to ensure that the trauma registries are eligible for comparisons between countries and healthcare systems, with the goal to improve trauma patient care worldwide.


Subject(s)
Quality of Life , Wounds and Injuries , Humans , Registries , Emergency Service, Hospital , Hospitals , Quality Improvement , Wounds and Injuries/epidemiology , Wounds and Injuries/therapy
15.
Cerebrovasc Dis ; 33(2): 98-103, 2012.
Article in English | MEDLINE | ID: mdl-22156574

ABSTRACT

When reading medical literature as a clinician, many different measures of association are presented. To judge whether results of studies can be applied to clinical practice, it is essential to understand and to be able to interpret the measure of association reported in the article. In this paper, we will present how to deal with the most commonly used measures of association including the risk and rate difference, number needed to treat, risk and rate ratio, hazard ratio and odds ratio. By means of examples, we will discuss the different measures of association for the three main study designs used in clinical research: randomized controlled trial, observational cohort study and case-control study.


Subject(s)
Biomedical Research , Research Design , Biomedical Research/statistics & numerical data , Case-Control Studies , Cohort Studies , Data Interpretation, Statistical , Endpoint Determination , Humans , Models, Statistical , Odds Ratio , Randomized Controlled Trials as Topic , Research Design/statistics & numerical data , Risk Assessment , Risk Factors , Sample Size , Time Factors , Treatment Outcome
16.
Epidemiol Infect ; 140(5): 823-34, 2012 May.
Article in English | MEDLINE | ID: mdl-21781368

ABSTRACT

The burden of respiratory infections is mainly seen in primary healthcare. To evaluate the potential impact of new preventive strategies against respiratory infections, such as the implementation of pneumococcal conjugate vaccines for infants in 2006 in The Netherlands, we conducted a baseline retrospective cohort study of electronic primary-care patient records to assess consultation rates, comorbidities and antibiotic prescription rates for respiratory infections in primary care. We found that between 1995 and 2005, overall registered consultation rates for lower respiratory tract infections had increased by 42·4%, upper respiratory infections declined by 4·9%, and otitis media remained unchanged. Concomitantly, there was a steady rise in overall comorbidity (75·7%) and antibiotic prescription rates (67·7%). Since Dutch primary-care rates for respiratory infections changed considerably between 1995 and 2005, these changes must be taken into account to properly evaluate the effect of population-based preventive strategies on primary-care utilization.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Pneumococcal Vaccines/administration & dosage , Prescriptions/statistics & numerical data , Primary Health Care/statistics & numerical data , Referral and Consultation/statistics & numerical data , Respiratory Tract Infections/drug therapy , Respiratory Tract Infections/epidemiology , Adolescent , Adult , Aged , Aged, 80 and over , Child , Child, Preschool , Cohort Studies , Comorbidity , Female , Humans , Infant , Male , Middle Aged , Netherlands/epidemiology , Otitis Media/drug therapy , Otitis Media/epidemiology , Otitis Media/prevention & control , Pneumococcal Vaccines/immunology , Respiratory Tract Infections/prevention & control , Retrospective Studies , Young Adult
17.
BJOG ; 119(8): 915-23, 2012 Jul.
Article in English | MEDLINE | ID: mdl-22568406

ABSTRACT

OBJECTIVE: To predict instrumental vaginal delivery or caesarean section for suspected fetal distress or failure to progress. DESIGN: Secondary analysis of a randomised trial. SETTING: Three academic and six non-academic teaching hospitals in the Netherlands. POPULATION: 5667 labouring women with a singleton term pregnancy in cephalic presentation. METHODS: We developed multinomial prediction models to assess the risk of operative delivery using both antepartum (model 1) and antepartum plus intrapartum characteristics (model 2). The models were validated by bootstrapping techniques and adjusted for overfitting. Predictive performance was assessed by calibration and discrimination (area under the receiver operating characteristic), and easy-to-use nomograms were developed. MAIN OUTCOME MEASURES: Incidence of instrumental vaginal delivery or caesarean section for fetal distress or failure to progress with respect to a spontaneous vaginal delivery (reference). RESULTS: 375 (6.6%) and 212 (3.6%) women had an instrumental vaginal delivery or caesarean section due to fetal distress, and 433 (7.6%) and 571 (10.1%) due to failure to progress, respectively. Predictors were age, parity, previous caesarean section, diabetes, gestational age, gender, estimated birthweight (model 1) and induction of labour, oxytocin augmentation, intrapartum fever, prolonged rupture of membranes, meconium stained amniotic fluid, epidural anaesthesia, and use of ST-analysis (model 2). Both models showed excellent calibration and the receiver operating characteristics areas were 0.70-0.78 and 0.73-0.81, respectively. CONCLUSION: In Dutch women with a singleton term pregnancy in cephalic presentation, antepartum and intrapartum characteristics can assist in the prediction of the need for an instrumental vaginal delivery or caesarean section for fetal distress or failure to progress.


Subject(s)
Delivery, Obstetric/statistics & numerical data , Fetal Distress/diagnosis , Obstetric Labor Complications/diagnosis , Adult , Cesarean Section/statistics & numerical data , Female , Humans , Models, Biological , Nomograms , Pregnancy , Pregnancy Outcome , ROC Curve , Risk Assessment , Risk Factors , Version, Fetal
18.
Contemp Clin Trials ; 121: 106899, 2022 10.
Article in English | MEDLINE | ID: mdl-36038002

ABSTRACT

OBJECTIVE: To investigate publication rates in small trials and to explore which factors are associated with publication rates in small trials, including sample size, the type and number of primary and secondary outcomes. STUDY DESIGN AND SETTING: We studied a subgroup of 'small' trials from a pre-existing dataset (IntoValue), containing German trials completed between 2009 and 2017. Small trials were defined as phase II-III, III and IV trials with 150 or fewer participants. We performed an updated publication search and collected additional data from online trial records. RESULTS: Out of 499 trials, 325 (65%) trials published their results in a journal article or dissertation. Median time-to-publication was 3.41 years (95% CI: 3.04-4.10). Planned sample size was not associated with publication rates, but the difference between planned and achieved sample size was (per 10% unsuccessfully recruited participants, HR = 0.95, 95% CI: 0.91-1.00). Phase III vs. II-III trials, studied intervention (device vs. other) and clearly vs. unclearly defined primary outcomes predicted a higher likelihood of earlier publication. CONCLUSION: About 35% of small trials in Germany remain unpublished, even after an extensive follow-up period of over 9 years. Publication rates are low and were associated with sample size, trial phase and type of intervention.


Subject(s)
Publishing , Germany , Humans
19.
Injury ; 53(3): 1144-1148, 2022 Mar.
Article in English | MEDLINE | ID: mdl-35063259

ABSTRACT

INTRODUCTION: Identification of high-risk hip fracture patients in an early stage is vital for guiding surgical management and shared decision making. To objective of this study was to perform an external international validation study of the U-HIP prediction model for in-hospital mortality in geriatric patients with a hip fracture undergoing surgery. MATERIALS AND METHODS: In this retrospective cohort study, data were used from The American College of Surgeons National Surgical Quality Improvement Program. Patients aged 70 years or above undergoing hip fracture surgery were included. The discrimination (c-statistic) and calibration of the model were investigated. RESULTS: A total of 25,502 patients were included, of whom 618 (2.4%) died. The mean predicted probability of in-hospital mortality was 3.9% (range 0%-55%). The c-statistic of the model was 0.74 (95% CI 0.72-0.76), which was comparable to the c-statistic of 0.78 (95% CI 0.71-0.85) that was found in the development cohort. The calibration plot indicated that the model was slightly overfitted, with a calibration-in-the-large of 0.015 and a calibration slope of 0.780. Within the subgroup of patients aged between 70 and 85, however, the c-statistic was 0.78 (95% CI 0.75-0.81), with good calibration (calibration slope 0.934). DISCUSSION AND CONCLUSION: The U-HIP model for in-hospital mortality in geriatric hip fractures was externally validated in a large international cohort, and showed a good discrimination and fair calibration. This model is freely available online and can be used to predict the risk of mortality, identify high-risk patients and aid clinical decision making.


Subject(s)
Hip Fractures , Aged , Aged, 80 and over , Calibration , Cohort Studies , Hip Fractures/surgery , Hospital Mortality , Humans , Retrospective Studies , Risk Factors
20.
Front Pharmacol ; 13: 803935, 2022.
Article in English | MEDLINE | ID: mdl-35401238

ABSTRACT

The number of treatment options for patients with metastatic renal cell carcinoma (mRCC) has significantly grown in the last 15 years. Although randomized controlled trials are fundamental in investigating mRCC treatment efficacy, their external validity can be limited. Therefore, the efficacy of the different treatment options should also be evaluated in clinical practice. We performed a chart review of electronic health records using text mining software to study the current treatment patterns and outcomes. mRCC patients from two large hospitals in the Netherlands, starting treatment between January 2015 and May 2020, were included. Data were collected from electronic health records using a validated text mining tool. Primary endpoints were progression-free survival (PFS) and overall survival (OS). Statistical analyses were performed using the Kaplan-Meier method. Most frequent first-line treatments were pazopanib (n = 70), sunitinib (n = 34), and nivolumab with ipilimumab (n = 28). The overall median PFS values for first-line treatment were 15.7 months (95% confidence interval [95%CI], 8.8-20.7), 16.3 months (95%CI, 9.3-not estimable [NE]) for pazopanib, and 6.9 months (95% CI, 4.4-NE) for sunitinib. The overall median OS values were 33.4 months (95%CI, 28.1-50.9 months), 39.3 months (95%CI, 29.5-NE) for pazopanib, and 28.1 months (95%CI, 7.0-NE) for sunitinib. For nivolumab with ipilimumab, median PFS and median OS were not reached. Of the patients who finished first- and second-line treatments, 64 and 62% received follow-up treatments, respectively. With most patients starting on pazopanib and sunitinib, these real-world treatment outcomes were most likely better than in pivotal trials, which may be due to extensive follow-up treatments.

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