Nonoperative treatment of multiple rib fractures, the results to beat: International multicenter prospective cohort study among 845 patients.

BACKGROUND: Optimal treatment (i.e. nonoperative or operative) for patients with multiple rib fractures remains debated. Studies that compare treatments are rationalized by the alleged poor outcomes of nonoperative treatment. METHODS: The aim of this prospective international multicenter cohort study (between January 2018 and March 2021) with one-year follow-up, was to report contemporary outcomes of nonoperatively treated patients with multiple rib fractures. Including 845 patients with three or more rib fractures. Primary outcome was in-hospital mortality. Secondary outcomes included hospital length of stay (HLOS), (pulmonary) complications, and quality of life. RESULTS: Mean age was 57.7 ± 17.0 years, median Injury Severity Score was 17 (13-22) and the median number of rib fractures was 6 (4-8). In-hospital mortality rate was 1.5% (n = 13), 112 (13.3%) patients had pneumonia and four (0.5%) patients developed a symptomatic non-union. The median HLOS was 7 (4-13) days, and median intensive care unit length of stay was 2 (1-5) days. Mean EQ-5D-5L index value was 0.83 ± 0.18 one year after trauma. Polytrauma patients had a median HLOS of 10 (6-18) days, a pneumonia rate of 17.6% (n = 77) and mortality rate of 1.7% (n = 7). Elderly patients (≥65 years) had a median HLOS of 9 (5-15) days, a pneumonia rate of 19.7% (n = 57) and mortality rate of 4.1% (n = 12). CONCLUSIONS: Overall, nonoperative treatment of patients with multiple rib fractures shows low mortality and morbidity rate and good quality of life after one year. Future studies evaluating the benefit of operative stabilisation should use contemporary outcomes to establish the therapeutic margin of rib fixation. LEVEL OF EVIDENCE: Level III, Therapeutic/Care Management.

Dynamics in cardiac surgery: trends in population characteristics and the performance of the EuroSCORE II over time.

OBJECTIVES: The aim of this study was to investigate the performance of the EuroSCORE II over time and dynamics in values of predictors included in the model. METHODS: A cohort study was performed using data from the Netherlands Heart Registration. All cardiothoracic surgical procedures performed between 1 January 2013 and 31 December 2019 were included for analysis. Performance of the EuroSCORE II was assessed across 3-month intervals in terms of calibration and discrimination. For subgroups of major surgical procedures, performance of the EuroSCORE II was assessed across 12-month time intervals. Changes in values of individual EuroSCORE II predictors over time were assessed graphically. RESULTS: A total of 103 404 cardiothoracic surgical procedures were included. Observed mortality risk ranged between 1.9% [95% confidence interval (CI) 1.6-2.4] and 3.6% (95% CI 2.6-4.4) across 3-month intervals, while the mean predicted mortality risk ranged between 3.4% (95% CI 3.3-3.6) and 4.2% (95% CI 3.9-4.6). The corresponding observed:expected ratios ranged from 0.50 (95% CI 0.46-0.61) to 0.95 (95% CI 0.74-1.16). Discriminative performance in terms of the c-statistic ranged between 0.82 (95% CI 0.78-0.89) and 0.89 (95% CI 0.87-0.93). The EuroSCORE II consistently overestimated mortality compared to observed mortality. This finding was consistent across all major cardiothoracic surgical procedures. Distributions of values of individual predictors varied broadly across predictors over time. Most notable trends were a decrease in elective surgery from 75% to 54% and a rise in patients with no or New York Heart Association I class heart failure from 27% to 33%. CONCLUSIONS: The EuroSCORE II shows good discriminative performance, but consistently overestimates mortality risks of all types of major cardiothoracic surgical procedures in the Netherlands.

Mobile health for cardiovascular risk management after cardiac surgery: results of a sub-analysis of The Box 2.0 study.

Aims: Lowering low-density lipoprotein (LDL-C) and blood pressure (BP) levels to guideline recommended values reduces the risk of major adverse cardiac events in patients who underwent coronary artery bypass grafting (CABG). To improve cardiovascular risk management, this study evaluated the effects of mobile health (mHealth) on BP and cholesterol levels in patients after standalone CABG. Methods and results: This study is a post hoc analysis of an observational cohort study among 228 adult patients who underwent standalone CABG surgery at a tertiary care hospital in The Netherlands. A total of 117 patients received standard care, and 111 patients underwent an mHealth intervention. This consisted of frequent BP and weight monitoring with regimen adjustment in case of high BP. Primary outcome was difference in systolic BP and LDL-C between baseline and value after three months of follow-up. Mean age in the intervention group was 62.7 years, 98 (88.3%) patients were male. A total of 26 449 mHealth measurements were recorded. At three months, systolic BP decreased by 7.0 mmHg [standard deviation (SD): 15.1] in the intervention group vs. -0.3 mmHg (SD: 17.6; P < 0.00001) in controls; body weight decreased by 1.76 kg (SD: 3.23) in the intervention group vs. -0.31 kg (SD: 2.55; P = 0.002) in controls. Serum LDL-C was significantly lower in the intervention group vs. controls (median: 1.8 vs. 2.0 mmol/L; P = 0.0002). Conclusion: This study showed an association between home monitoring after CABG and a reduction in systolic BP, body weight, and serum LDL-C. The causality of the association between the observed weight loss and decreased LDL-C in intervention group patients remains to be investigated.

Confounding adjustment in observational studies on cardiothoracic interventions: a systematic review of methodological practice.

OBJECTIVES: It is unknown which confounding adjustment methods are currently used in the field of cardiothoracic surgery and whether these are appropriately applied. The aim of this study was to systematically evaluate the quality of conduct and reporting of confounding adjustment methods in observational studies on cardiothoracic interventions. METHODS: A systematic review was performed, which included all observational studies that compared different interventions and were published between 1 January and 1 July 2022, in 3 European and American cardiothoracic surgery journals. Detailed information on confounding adjustment methods was extracted and subsequently described. RESULTS: Ninety-two articles were included in the analysis. Outcome regression (n = 49, 53%) and propensity score (PS) matching (n = 44, 48%) were most popular (sometimes used in combination), whereas 11 (12%) studies applied no method at all. The way of selecting confounders was not reported in 42 (46%) of the studies, solely based on previous literature or clinical knowledge in 14 (16%), and (partly) data-driven in 25 (27%). For the studies that applied PS matching, the matched cohorts comprised on average 46% of the entire study population (range 9-82%). CONCLUSIONS: Current reporting of confounding adjustment methods is insufficient in a large part of observational studies on cardiothoracic interventions, which makes quality judgement difficult. Appropriate application of confounding adjustment methods is crucial for causal inference on optimal treatment strategies for clinical practice. Reporting on these methods is an important aspect of this, which can be improved.

In patients with combined clavicle and multiple rib fractures, does fracture fixation of the clavicle improve clinical outcomes? A multicenter prospective cohort study of 232 patients.

BACKGROUND: Clavicle and rib fractures are often sustained concomitantly. The combination of injuries may result in decreased stability of the chest wall, making these patients prone to (respiratory) complications and prolonged hospitalization. This study aimed to assess whether adding chest wall stability by performing clavicle fixation improves clinical outcomes in patients with concurrent clavicle and rib fractures. METHODS: A prospective multicenter study was performed including all adult patients admitted between January 2018 and March 2021 with concurrent ipsilateral clavicle and rib fractures. Patients treated operatively versus nonoperatively for their clavicle fracture were matched using propensity score matching. The primary outcome was hospital length of stay (HLOS). Secondary outcomes were intensive care unit length of stay, duration of mechanical ventilation, pain, complications, and quality of life at 6 weeks and 12 months of follow-up. RESULTS: In total, 232 patients with concomitant ipsilateral clavicle and rib fractures were included. Fifty-two patients (22%) underwent operative treatment of which 39 could be adequately matched to 39 nonoperatively treated patients. No association was observed between clavicle plate fixation and HLOS (mean difference, 2.3 days; 95% confidence interval, -2.1 to 6.8; p = 0.301) or any secondary endpoint. Eight of the 180 nonoperatively treated patients (4%) had a symptomatic nonunion, for which 5 underwent secondary clavicle fixation. CONCLUSION: We found no evidence that, in patients with combined clavicle and multiple rib fractures, plate fixation of the clavicle reduces HLOS, pain, or (pulmonary) complications, nor that it improves quality of life. STUDY TYPE: Therapeutic/Care Management; Level III.

Intravesical aminoglycoside instillations as prophylaxis for recurrent urinary tract infection: patient satisfaction, long-term safety and efficacy.

Background: Recurrent urinary tract infections (UTIs) are common, especially in women. When oral antimicrobial prophylaxis is ineffective or not possible due to allergies or antimicrobial resistance, intravesical aminoglycoside instillations (IAIs) are a non-systemic alternative. Objectives: To assess treatment satisfaction, long-term safety and efficacy of IAIs for recurrent UTI. Methods: We conducted a cohort study using data collected between January 2013 and June 2022 at the Leiden University Medical Center. Adult patients with recurrent UTI who received prophylactic IAI were eligible for inclusion. Treatment satisfaction was assessed through a survey. Data on serum aminoglycoside concentrations, cystoscopy results and number of recurrences were obtained through chart review. Number of recurrences and UTI characteristics were compared between patients on and off IAI using Poisson and logistic mixed effects models. Results: Forty-four patients were included (median follow-up time 976 days) and 323 UTIs occurred during follow-up. Overall treatment satisfaction was high (median 79.2/100). All but one patient had undetectable serum aminoglycoside levels and no malignancies were found on follow-up cystoscopy. IAI increased the time to first recurrence (102 days versus 36 days, P = 0.02), reduced the number of recurrences (rate ratio 0.75, 95% CI 0.56-0.99, P = 0.04) and the necessity for systemic antibiotics (OR 0.33, 95% CI 0.13-0.86, P = 0.02). Conclusions: In patients with recurrent UTI, IAI was associated with high treatment satisfaction, and was found to be a safe and effective alternative to oral antimicrobial prophylaxis.

Quality of life and clinical outcomes of operatively treated patients with flail chest injuries: A multicentre prospective cohort study.

Introduction: Most studies about rib fractures focus on mortality and morbidity. Literature is scarce on long term and quality of life (QoL) outcomes. Therefore, we report QoL and long-term outcomes after rib fixation in flail chest patients. Methods: A prospective cohort study of clinical flail chest patients admitted to six level 1 trauma centres in the Netherlands and Switzerland between January 2018 and March 2021. Outcomes included in-hospital outcomes and long-term outcomes, such as QoL measurements 12 months after hospitalization using the EuroQoL five dimensions (EQ-5D) questionnaire. Results: Sixty-one operatively treated flail chest patients were included. Median hospital length of stay was 15 days and intensive care length of stay was 8 days. Sixteen (26%) patients developed pneumonia and two (3%) died. One year after hospitalization the mean EQ5D score was 0.78. Complication rates were low and included hemothorax (6%) pleural effusion (5%) and two revisions of the implant (3%). Implant related irritation was commonly reported by patients (n = 15, 25%). Conclusions: Rib fixation for flail chest injuries can be considered a safe procedure and with low mortality rates. Future studies should focus on quality of life rather than solely short-term outcomes.Trial registration: Registered in the Netherlands Trial Register NTR6833 on 13/11/2017 and the Swiss Ethics Committees Registration Number 2019-00668.

SCORE2 cardiovascular risk prediction models in an ethnic and socioeconomic diverse population in the Netherlands: an external validation study.

Background: Socioeconomic status and ethnicity are not explicitly incorporated as risk factors in the four SCORE2 cardiovascular disease (CVD) risk models developed for country-wide implementation across Europe (low, moderate, high and very-high model). The aim of this study was to evaluate the performance of the four SCORE2 CVD risk prediction models in an ethnic and socioeconomic diverse population in the Netherlands. Methods: The SCORE2 CVD risk models were externally validated in socioeconomic and ethnic (by country of origin) subgroups, from a population-based cohort in the Netherlands, with GP, hospital and registry data. In total 155,000 individuals, between 40 and 70 years old in the study period from 2007 to 2020 and without previous CVD or diabetes were included. Variables (age, sex, smoking status, blood pressure, cholesterol) and outcome first CVD event (stroke, myocardial infarction, CVD death) were consistent with SCORE2. Findings: 6966 CVD events were observed, versus 5495 events predicted by the CVD low-risk model (intended for use in the Netherlands). Relative underprediction was similar in men and women (observed/predicted (OE-ratio), 1.3 and 1.2 in men and women, respectively). Underprediction was larger in low socioeconomic subgroups of the overall study population (OE-ratio 1.5 and 1.6 in men and women, respectively), and comparable in Dutch and the combined "other ethnicities" low socioeconomic subgroups. Underprediction in the Surinamese subgroup was largest (OE-ratio 1.9, in men and women), particularly in the low socioeconomic Surinamese subgroups (OE-ratio 2.5 and 2.1 in men and women). In the subgroups with underprediction in the low-risk model, the intermediate or high-risk SCORE2 models showed improved OE-ratios. Discrimination showed moderate performance in all subgroups and the four SCORE2 models, with C-statistics between 0.65 and 0.72, similar to the SCORE2 model development study. Interpretation: The SCORE 2 CVD risk model for low-risk countries (as the Netherlands are) was found to underpredict CVD risk, particularly in low socioeconomic and Surinamese ethnic subgroups. Including socioeconomic status and ethnicity as predictors in CVD risk models and implementing CVD risk adjustment within countries is desirable for adequate CVD risk prediction and counselling. Funding: Leiden University Medical Centre and Leiden University.

The association of radiologic body composition parameters with clinical outcomes in level-1 trauma patients.

PURPOSE: The present study aims to assess whether CT-derived muscle mass, muscle density, and visceral fat mass are associated with in-hospital complications and clinical outcome in level-1 trauma patients. METHODS: A retrospective cohort study was conducted on adult patients admitted to the University Medical Center Utrecht following a trauma between January 1 and December 31, 2017. Trauma patients aged 16 years or older without severe neurological injuries, who underwent a CT that included the abdomen within 7 days of admission, were included. An artificial intelligence (AI) algorithm was used to retrieve muscle areas to calculate the psoas muscle index and to retrieve psoas muscle radiation attenuation and visceral fat (VF) area from axial CT images. Multivariable logistic and linear regression analyses were performed to assess associations between body composition parameters and outcomes. RESULTS: A total of 404 patients were included for analysis. The median age was 49 years (interquartile range [IQR] 30-64), and 66.6% were male. Severe comorbidities (ASA 3-4) were seen in 10.9%, and the median ISS was 9 (IQR 5-14). Psoas muscle index was not independently associated with complications, but it was associated with ICU admission (odds ratio [OR] 0.79, 95% confidence interval [CI] 0.65-0.95), and an unfavorable Glasgow Outcome Scale (GOS) score at discharge (OR 0.62, 95% CI 0.45-0.85). Psoas muscle radiation attenuation was independently associated with the development of any complication (OR 0.60, 95% CI 0.42-0.85), pneumonia (OR 0.63, 95% CI 0.41-0.96), and delirium (OR 0.49, 95% CI 0.28-0.87). VF was associated with developing a delirium (OR 1.95, 95% CI 1.12-3.41). CONCLUSION: In level-1 trauma patients without severe neurological injuries, automatically derived body composition parameters are able to independently predict an increased risk of specific complications and other poor outcomes.

Non-operative vs. operative treatment for multiple rib fractures after blunt thoracic trauma: a multicenter prospective cohort study.

BACKGROUND: Patients with multiple rib fractures without a clinical flail chest are increasingly being treated with rib fixation; however, high-quality evidence to support this development is lacking. METHODS: We conducted a prospective multicenter observational study comparing rib fixation to non-operative treatment in all patients aged 18 years and older with computed tomography confirmed multiple rib fractures without a clinical flail chest. Three centers performed rib fixation as standard of care. For adequate comparison, the other three centers performed only non-operative treatment. As such clinical equipoise formed the basis for the comparison in this study. Patients were matched using propensity score matching. RESULTS: In total 927 patients with multiple rib fractures were included. In the three hospitals that performed rib fixation, 80 (14%) out of 591 patients underwent rib fixation. From the nonoperative centers, on average 71 patients were adequately matched to 71 rib fixation patients after propensity score matching. Rib fixation was associated with an increase in hospital length of stay (HLOS) of 4.9 days (95%CI 0.8-9.1, p = 0.02) and a decrease in quality of life (QoL) measured by the EQ5D questionnaire at 1 year of 0.1 (95% CI - 0.2-0.0, p = 0.035) compared to non-operative treatment. A subgroup analysis of patients who received operative care within 72 h showed a similar decrease in QoL. Up to 22 patients (28%) who underwent surgery experienced implant-related irritation. CONCLUSIONS: We found no benefits and only detrimental effects associated with rib fixation. Based on these results, we do not recommend rib fixation as the standard of care for patients with multiple rib fractures. TRIAL REGISTRATION: Registered in the Netherlands Trial Register NTR6833 on 13/11/2017.

Mobile health vs. standard care after cardiac surgery: results of The Box 2.0 study.

AIMS: Postoperative atrial fibrillation (POAF) is a common complication of cardiac surgery, yet difficult to detect in ambulatory patients. The primary aim of this study is to investigate the effect of a mobile health (mHealth) intervention on POAF detection after cardiac surgery. METHODS AND RESULTS: We performed an observational cohort study among 730 adult patients who underwent cardiac surgery at a tertiary care hospital in The Netherlands. Of these patients, 365 patients received standard care and were included as a historical control group, undergoing surgery between December 2017 and September 2018, and 365 patients were prospectively included from November 2018 and November 2020, undergoing an mHealth intervention which consisted of blood pressure, temperature, weight, and electrocardiogram (ECG) monitoring. One physical outpatient follow-up moment was replaced by an electronic visit. All patients were requested to fill out a satisfaction and quality of life questionnaire. Mean age in the intervention group was 62 years, 275 (70.4%) patients were males. A total of 4136 12-lead ECGs were registered. In the intervention group, 61 (16.7%) patients were diagnosed with POAF vs. 25 (6.8%) patients in the control group [adjusted risk ratio (RR) of POAF detection: 2.15; 95% confidence interval (CI): 1.55-3.97]. De novo atrial fibrillation was found in 13 patients using mHealth (6.5%) vs. 4 control group patients (1.8%; adjusted RR 3.94, 95% CI: 1.50-11.27). CONCLUSION: Scheduled self-measurements with mHealth devices could increase the probability of detecting POAF within 3 months after cardiac surgery. The effect of an increase in POAF detection on clinical outcomes needs to be addressed in future research.

The robustness of the flow-gradient classification of severe aortic stenosis.

Objectives: A flow-gradient classification is used to determine the indication for intervention for patients with severe aortic stenosis (AS) with discordant echocardiographic parameters. We investigated the agreement in flow-gradient classification by stroke volume (SV) measurement at the left ventricular outflow tract (LVOT) and at the left ventricle. Methods: Data were used from a prospective cohort study and patients with severe AS (aortic valve area index ≤0.6 cm2/m2) with preserved ejection fraction (>50%) were selected. SV was determined by an echocardiographic core laboratory at the LVOT and by subtracting the 2-dimensional left ventricle end-systolic from the end-diastolic volume (volumetric). Patients were stratified into 4 groups based on SV index (35 mL/m2) and mean gradient (40 mm Hg). The group composition was compared and the agreement between the SV measurements was investigated using regression, correlation, and limits of agreement. In addition, a systematic LVOT diameter overestimation of 1 mm was simulated to study flow-gradient reclassification. Results: Of 1118 patients, 699 were eligible. The group composition changed considerably as agreement on flow state occurred in only 50% of the measurements. LVOT SV was on average 15.1 mL (95% limits of agreement -24.9:55.1 mL) greater than volumetric SV. When a systematic 1-mm LVOT diameter overestimation was introduced, the low-flow groups halved. Conclusions: There was poor agreement in the flow-gradient classification of severe AS as a result of large differences between LVOT and volumetric SV. Furthermore, this classification was sensitive to small measurement errors. These results stress that parameters beyond the flow-gradient classification should be considered to ensure accurate recommendations for intervention.

How to assess applicability and methodological quality of comparative studies of operative interventions in orthopedic trauma surgery.

PURPOSE: It is challenging to generate and subsequently implement high-quality evidence in surgical practice. A first step would be to grade the strengths and weaknesses of surgical evidence and appraise risk of bias and applicability. Here, we described items that are common to different risk-of-bias tools. We explained how these could be used to assess comparative operative intervention studies in orthopedic trauma surgery, and how these relate to applicability of results. METHODS: We extracted information from the Cochrane risk-of-bias-2 (RoB-2) tool, Risk Of Bias In Non-randomised Studies-of Interventions tool (ROBINS-I), and Methodological Index for Non-Randomized Studies (MINORS) criteria and derived a concisely formulated set of items with signaling questions tailored to operative interventions in orthopedic trauma surgery. RESULTS: The established set contained nine items: population, intervention, comparator, outcome, confounding, missing data and selection bias, intervention status, outcome assessment, and pre-specification of analysis. Each item can be assessed using signaling questions and was explained using good practice examples of operative intervention studies in orthopedic trauma surgery. CONCLUSION: The set of items will be useful to form a first judgment on studies, for example when including them in a systematic review. Existing risk of bias tools can be used for further evaluation of methodological quality. Additionally, the proposed set of items and signaling questions might be a helpful starting point for peer reviewers and clinical readers.

Epidemiology and outcome of rib fractures: a nationwide study in the Netherlands.

PURPOSE: Rib fractures following thoracic trauma are frequently encountered injuries and associated with a significant morbidity and mortality. The aim of this study was to provide current data on the epidemiology, in-hospital outcomes and 30-day mortality of rib fractures, and to evaluate these results for different subgroups. METHODS: A nationwide retrospective cohort study was performed with the use of the Dutch Trauma Registry which covers 99% of the acutely admitted Dutch trauma population. All patients aged 18 years and older admitted to the hospital between January 2015 and December 2017 with one or more rib fractures were included. Incidence rates were calculated using demographic data from the Dutch Population Register. Subgroup analyses were performed for flail chest, polytrauma, primary thoracic trauma, and elderly patients. RESULTS: A total of 14,850 patients were admitted between 2015 and 2017 with one or more rib fractures, which was 6.0% of all trauma patients. Of these, 573 (3.9%) patients had a flail chest, 4438 (29.9%) were polytrauma patients, 9273 (63.4%) were patients with primary thoracic trauma, and 6663 (44.9%) were elderly patients. The incidence rate of patients with rib fractures for the entire cohort was 29 per 100.000 person-years. The overall 30-day mortality was 6.9% (n = 1208) with higher rates observed in flail chest (11.9%), polytrauma (14.8%), and elderly patients (11.7%). The median hospital length of stay was 6 days (IQR, 3-11) and 37.3% were admitted to the intensive care unit (ICU). CONCLUSIONS: Rib fractures are a relevant and frequently occurring problem among the trauma population. Subgroup analyses showed that there is a substantial heterogeneity among patients with rib fractures with considerable differences regarding the epidemiology, in-hospital outcomes, and 30-day mortality.

MIPO versus nailing for humeral shaft fractures: a meta-analysis and systematic review of randomised clinical trials and observational studies.

PURPOSE: There is no consensus on the optimal operative technique for humeral shaft fractures. This meta-analysis aims to compare minimal-invasive plate osteosynthesis (MIPO) with nail fixation for humeral shaft fractures regarding healing, complications and functional results. METHODS: PubMed/Medline/Embase/CENTRAL/CINAHL were searched for randomized clinical trials (RCT) and observational studies comparing MIPO with nailing for humeral shaft fractures. Effect estimates were pooled across studies using random effects models and presented as weighted odds ratio (OR), risk difference (RD), mean difference (MD) and standardized mean difference (SMD) with corresponding 95% confidence interval (95%CI). Analyses were repeated stratified by study design (RCTs and observational studies). RESULTS: A total of 2 RCTs (87 patients) and 5 observational studies (595 patients) were included. The effects estimated in observational studies and RCTs were similar in direction and magnitude for all outcomes except operation duration. MIPO has a lower risk for non-union (RD 7%; OR 0.2, 95% CI 0.1-0.5) and re-intervention (RD 13%; OR 0.3, 95% CI 0.1-0.8). Functional shoulder (SMD 1.0, 95% CI 0.2-1.8) and elbow scores (SMD 0.4, 95% CI 0-0.8) were better among patients treated with MIPO. The risk for radial nerve palsy following surgery was equal (RD 2%; OR 0.6, 95% CI 0.3-1.2) and nerve function recovered spontaneously in all patients in both groups. No difference was detected with regard to infection, time to union and operation duration. CONCLUSION: MIPO has a considerable lower risk for non-union and re-intervention, leads to better shoulder function and, to a lesser extent, better elbow function compared to nailing. Although nailing appears to be a viable option, the evidence suggests that MIPO should be the preferred treatment of choice. The learning curve of minimal-invasive plating should, however, be taken into account when interpreting these results.

Effects of exercise in breast cancer patients: implications of the trials within cohorts (TwiCs) design in the UMBRELLA Fit trial.

PURPOSE: The Trials within Cohorts (TwiCs) design aims to overcome problems faced in conventional RCTs. We evaluated the TwiCs design when estimating the effect of exercise on quality of life (QoL) and fatigue in inactive breast cancer survivors. METHODS: UMBRELLA Fit was conducted within the prospective UMBRELLA breast cancer cohort. Patients provided consent for future randomization at cohort entry. We randomized inactive patients 12-18 months after cohort enrollment. The intervention group (n = 130) was offered a 12-week supervised exercise intervention. The control group (n = 130) was not informed and received usual care. Six-month exercise effects on QoL and fatigue as measured in the cohort were analyzed with intention-to-treat (ITT), instrumental variable (IV), and propensity scores (PS) analyses. RESULTS: Fifty-two percent (n = 68) of inactive patients accepted the intervention. Physical activity increased in patients in the intervention group, but not in the control group. We found no benefit of exercise for dimensions of QoL (ITT difference global QoL: 0.8, 95% CI = - 2.2; 3.8) and fatigue, except for a small beneficial effect on physical fatigue (ITT difference: - 1.1, 95% CI = - 1.8; - 0.3; IV: - 1.9, 95% CI = - 3.3; - 0.5, PS: - 1.2, 95% CI = - 2.3; - 0.2). CONCLUSION: TwiCs gave insight into exercise intervention acceptance: about half of inactive breast cancer survivors accepted the offer and increased physical activity levels. The offer resulted in no improvement on QoL, and a small beneficial effect on physical fatigue. TRIAL REGISTRATION: Netherlands Trial Register (NTR5482/NL.52062.041.15), date of registration: December 07, 2015.

Expected individual benefit of prophylactic platelet transfusions in hemato-oncology patients based on bleeding risks.

BACKGROUND: Prophylactic platelet transfusions prevent bleeding in hemato-oncology patients, but it is unclear how any benefit varies between patients. Our aim was to assess if patients with different baseline risks for bleeding benefit differently from a prophylactic platelet transfusion strategy. STUDY DESIGN AND METHODS: Using the data from the randomized controlled TOPPS trial (Trial of Platelet Prophylaxis), we developed a prediction model for World Health Organization grades 2, 3, and 4 bleeding risk (defined as at least one bleeding episode in a 30 days period) and grouped patients in four risk-quartiles based on this predicted baseline risk. Predictors in the model were baseline platelet count, age, diagnosis, disease modifying treatment, disease status, previous stem cell transplantation, and the randomization arm. RESULTS: The model had a c-statistic of 0.58 (95% confidence interval [CI] 0.54-0.64). There was little variation in predicted risks (quartiles 46%, 47%, and 51%), but prophylactic platelet transfusions gave a risk reduction in all risk quartiles. The absolute risk difference (ARD) was 3.4% (CI -12.2 to 18.9) in the lowest risk quartile (quartile 1), 7.4% (95% CI -8.4 to 23.3) in quartile 2, 6.8% (95% CI -9.1 to 22.9) in quartile 3, and 12.8% (CI -3.1 to 28.7) in the highest risk quartile (quartile 4). CONCLUSION: In our study, generally accepted bleeding risk predictors had limited predictive power (expressed by the low c-statistic), and, given the wide confidence intervals of predicted ARD, could not aid in identifying subgroups of patients who might benefit more (or less) from prophylactic platelet transfusion.

Is a chest radiograph indicated after chest tube removal in trauma patients? A systematic review.

PURPOSE: The aim of this systematic review was to assess the necessity of routine chest radiographs after chest tube removal in ventilated and nonventilated trauma patients. METHODS: A systematic literature search was conducted in MEDLINE, Embase, CENTRAL, and CINAHL on May 15, 2020. Quality assessment was performed using the Methodological Index for Nonrandomized Studies criteria. Primary outcome measures were abnormalities on postremoval chest radiograph (e.g., recurrence of a pneumothorax, hemothorax, pleural effusion) and reintervention after chest tube removal. Secondary outcome measures were emergence of new clinical symptoms or vital signs after chest tube removal. RESULTS: Fourteen studies were included, consisting of seven studies on nonventilated patients and seven studies on combined cohorts of ventilated and nonventilated patients, all together containing 1,855 patients. Nonventilated patients had abnormalities on postremoval chest radiograph in 10% (range across studies, 0-38%) of all chest tubes and 24% (range, 0-78%) of those underwent reintervention. In the studies that reported on clinical symptoms after chest tube removal, all patients who underwent reintervention also had symptoms of recurrent pathology. Combined cohorts of ventilated and nonventilated patients had abnormalities on postremoval chest radiograph in 20% (range, 6-49%) of all chest tubes and 45% (range, 8-63%) of those underwent reintervention. CONCLUSION: In nonventilated patients, one in ten developed recurrent pathology after chest tube removal and almost a quarter of them underwent reintervention. In two studies that reported on clinical symptoms, all reinterventions were performed in patients with symptoms of recurrent pathology. In these two studies, omission of routine postremoval chest radiograph seemed safe. However, current literature remains insufficient to draw definitive conclusions on this matter, and future studies are needed. LEVEL OF EVIDENCE: Systematic review study, level IV.