Cost-effectiveness of postoperative imaging surveillance strategies for nonfunctional pituitary adenomas after resection with curative intent.

OBJECTIVE: The aim of this study was to determine an optimal follow-up imaging surveillance strategy in terms of cost-effectiveness after resection of nonfunctioning pituitary adenomas with curative intent. METHODS: An individual-level state-transition microsimulation model was used to simulate costs and outcomes associated with three postoperative imaging strategies over a lifetime time horizon: 1) annual MRI surveillance, 2) tapered MRI surveillance (annual surveillance for 5 years followed by surveillance every 2 years), and 3) personalized surveillance (annual surveillance for 5 years followed by surveillance every 2 years when MRI shows remnant disease/postoperative changes, and surveillance at 7, 10, and 15 years for disease-free MRI). Transition probabilities, utilities, and costs were estimated from recent published data and discounted by 3% annually. Model outcomes included lifetime costs (2022 US dollars), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). RESULTS: Under base case assumptions, annual surveillance yielded higher costs and lower health effects (QALYs) compared with the tapered and personalized surveillance strategies (dominated). Personalized surveillance demonstrated an additional 0.1 QALY at additional cost ($1298) compared with tapered surveillance (7.7 QALYs at a cost of $12,862). The ICER was $11,793/QALY. The optimal decision was most sensitive to the probability of postoperative changes on MRI after surgery and MRI cost. Accounting for parameter uncertainty, personalized surveillance had a higher probability of being a cost-effective surveillance option compared with the alternative strategies at 79%. CONCLUSIONS: Using standard cost-effectiveness thresholds in the US ($100,000/QALY), personalized surveillance that accounted for remnant disease or postoperative changes on MRI was cost-effective compared with alternative surveillance strategies.

Post-operative surveillance for somatotroph, lactotroph and non-functional pituitary adenomas after curative resection: a systematic review.

CONTEXT: Pituitary tumors are the third most common brain tumor and yet there is no standardization of the surveillance schedule and assessment modalities after transsphenoidal surgery. EVIDENCE ACQUISITION: OVID, EMBASE and the Cochrane Library databases were systematically screened from database inception to March 5, 2020. Inclusion and exclusion criteria were designed to capture studies examining detection of pituitary adenoma recurrence in patients 18 years of age and older following surgical resection with curative intent. EVIDENCE SYNTHESIS: A total of 7936 abstracts were screened, with 812 articles reviewed in full text and 77 meeting inclusion criteria for data extraction. A pooled analysis demonstrated recurrence rates at 1 year, 5 years and 10 years for non-functioning pituitary adenomas (NFPA; N = 3533 participants) were 1%, 17%, and 33%, for prolactin-secreting adenomas (PSPA; N = 1295) were 6%, 21%, and 28%, and for growth-hormone pituitary adenomas (GHPA; N = 1257) were 3%, 8% and 13%, respectively. Rates of recurrence prior to 1 year were 0% for NFPA, 1-2% for PSPA and 0% for GHPA. The mean time to disease recurrence for NFPA, PSPA and GHPA were 4.25, 2.52 and 4.18 years, respectively. CONCLUSIONS: This comprehensive review of the literature quantified the recurrence rates for commonly observed pituitary adenomas after transsphenoidal surgical resection with curative intent. Our findings suggest that surveillance within 1 year may be of low yield. Further clinical trials and cohort studies investigating cost-effectiveness of surveillance schedules and impact on quality of life of patients under surveillance will provide further insight to optimize follow-up.

Cost-effectiveness of direct surgery versus preoperative octreotide therapy for growth-hormone secreting pituitary adenomas.

PURPOSE: The objective of this study was to compare the cost-effectiveness of preoperative octreotide therapy followed by surgery versus the standard treatment modality for growth-hormone secreting pituitary adenomas, direct surgery (that is, surgery without preoperative treatment) from a public third-party payer perspective. METHODS: We developed an individual-level state-transition microsimulation model to simulate costs and outcomes associated with preoperative octreotide therapy followed by surgery and direct surgery for patients with growth-hormone secreting pituitary adenomas. Transition probabilities, utilities, and costs were estimated from recent published data and discounted by 3% annually over a lifetime time horizon. Model outcomes included lifetime costs [2020 United States (US) Dollars], quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs). RESULTS: Under base case assumptions, direct surgery was found to be the dominant strategy as it yielded lower costs and greater health effects (QALYs) compared to preoperative octreotide strategy in the second-order Monte Carlo microsimulation. The ICER was most sensitive to probability of remission following primary therapy and duration of preoperative octreotide therapy. Accounting for joint parameter uncertainty, direct surgery had a higher probability of demonstrating a cost-effective profile compared to preoperative octreotide treatment at 77% compared to 23%, respectively. CONCLUSIONS: Using standard benchmarks for cost-effectiveness in the US ($100,000/QALY), preoperative octreotide therapy followed by surgery may not be cost-effective compared to direct surgery for patients with growth-hormone secreting pituitary adenomas but the result is highly sensitive to initial treatment failure and duration of preoperative treatment.

Long-term Follow-up of a Randomized Clinical Trial Comparing Endovascular Revascularization Plus Supervised Exercise With Supervised Exercise Only for Intermittent Claudication.

OBJECTIVE: The goal of this study was to assess the long-term effectiveness of combination therapy for intermittent claudication, compared with supervised exercise only. BACKGROUND: Supervised exercise therapy is recommended as first-line treatment for intermittent claudication by recent guidelines. Combining endovascular revascularization plus supervised exercise shows promising results; however, there is a lack of long-term follow-up. METHODS: The ERASE study is a multicenter randomized clinical trial, including patients between May 2010 and February 2013 with intermittent claudication. Interventions were combination of endovascular revascularization plus supervised exercise (n = 106) or supervised exercise only (n = 106). Primary endpoint was the difference in maximum walking distance at long-term follow-up. Secondary endpoints included differences in pain-free walking distance, ankle-brachial index, quality of life, progression to critical limb ischemia, and revascularization procedures during follow-up. This randomized trial report is based on a post hoc analysis of extended follow-up beyond that of the initial trial. Patients were followed up until 31 July 2017. Data were analyzed according to the intention-to-treat principle. RESULTS: Median long-term follow-up was 5.4 years (IQR 4.9-5.7). Treadmill test was completed for 128/212 (60%) patients. Whereas the difference in maximum walking distance significantly favored combination therapy at 1-year follow-up, the difference at 5-year follow-up was no longer significant (53 m; 99% CI-225 to 331; P = 0.62). No difference in pain-free walking distance, ankle-brachial index, and quality of life was found during long-term follow-up. We found that supervised exercise was associated with an increased hazard of a revascularization procedure during follow-up (HR 2.50; 99% CI 1.27-4.90; P < 0.001). The total number of revascularization procedures (including randomized treatment) was lower in the exercise only group compared to that in the combination therapy group (65 vs 149). CONCLUSIONS: Long-term follow up after combination therapy versus supervised exercise only, demonstrated no significant difference in walking distance or quality of life between the treatment groups. Combination therapy resulted in a lower number of revascularization procedures during follow-up but a higher total number of revascularizations including the randomized treatment. TRIAL REGISTRATION: Netherlands Trial Registry Identifier: NTR2249.

Cost-effectiveness of a hybrid emergency room system for severe trauma: a health technology assessment from the perspective of the third-party payer in Japan.

BACKGROUND: Hybrid emergency room (ER) systems, consisting of an angiography-computed tomography (CT) machine in a trauma resuscitation room, are reported to be effective for reducing death from exsanguination in trauma patients. We aimed to investigate the cost-effectiveness of a hybrid ER system in severe trauma patients without severe traumatic brain injury (TBI). METHODS: We conducted a cost-utility analysis comparing the hybrid ER system to the conventional ER system from the perspective of the third-party healthcare payer in Japan. A short-term decision tree and a long-term Markov model using a lifetime time horizon were constructed to estimate quality-adjusted life years (QALYs) and associated lifetime healthcare costs. Short-term mortality and healthcare costs were derived from medical records and claims data in a tertiary care hospital with a hybrid ER. Long-term mortality and utilities were extrapolated from the literature. The willingness-to-pay threshold was set at $47,619 per QALY gained and the discount rate was 2%. Deterministic and probabilistic sensitivity analyses were conducted. RESULTS: The hybrid ER system was associated with a gain of 1.03 QALYs and an increment of $33,591 lifetime costs compared to the conventional ER system, resulting in an ICER of $32,522 per QALY gained. The ICER was lower than the willingness-to-pay threshold if the odds ratio of 28-day mortality was < 0.66. Probabilistic sensitivity analysis indicated that the hybrid ER system was cost-effective with a 79.3% probability. CONCLUSION: The present study suggested that the hybrid ER system is a likely cost-effective strategy for treating severe trauma patients without severe TBI.

Quantified health and cost effects of faster endovascular treatment for large vessel ischemic stroke patients in the Netherlands.

BACKGROUND: The effectiveness of endovascular treatment (EVT) for large vessel occlusion (LVO) stroke severely depends on time to treatment. However, it remains unclear what the value of faster treatment is in the years after index stroke. The aim of this study was to quantify the value of faster EVT in terms of health and healthcare costs for the Dutch LVO stroke population. METHODS: A Markov model was used to simulate 5-year follow-up functional outcome, measured with the modified Rankin Scale (mRS), of 69-year-old LVO patients. Post-treatment mRS was extracted from the MR CLEAN Registry (n=2892): costs per unit of time and Quality-Adjusted Life Years (QALYs) per mRS sub-score were retrieved from follow-up data of the MR CLEAN trial (n=500). Net Monetary Benefit (NMB) at a willingness to pay of €80 000 per QALY was reported as primary outcome, and secondary outcome measures were days of disability-free life gained and costs. RESULTS: EVT administered 1 min faster resulted in a median NMB of €309 (IQR: 226;389), 1.3 days of additional disability-free life (IQR: 1.0;1.6), while cumulative costs remained largely unchanged (median: -€15, IQR: -65;33) over a 5-year follow-up period. As costs over the follow-up period remained stable while QALYs decreased with longer time to treatment, which this results in a near-linear decrease of NMB. Since patients with faster EVT lived longer, they incurred more healthcare costs. CONCLUSION: One-minute faster EVT increases QALYs while cumulative costs remain largely unaffected. Therefore, faster EVT provides better value of care at no extra healthcare costs.

Evidence-Based Medicine in Otolaryngology, Part XI: Modeling and Analysis to Support Decisions.

OBJECTIVE: To provide a resource to educate clinical decision makers about the analyses and models that can be employed to support data-driven choices. DATA SOURCES: Published studies and literature regarding decision analysis, decision trees, and models used to support clinical decisions. REVIEW METHODS: Decision models provide insights into the evidence and its implications for those who make choices about clinical care and resource allocation. Decision models are designed to further our understanding and allow exploration of the common problems that we face, with parameters derived from the best available evidence. Analysis of these models demonstrates critical insights and uncertainties surrounding key problems via a readily interpretable yet quantitative format. This 11th installment of the Evidence-Based Medicine in Otolaryngology series thus provides a step-by-step introduction to decision models, their typical framework, and favored approaches to inform data-driven practice for patient-level decisions, as well as comparative assessments of proposed health interventions for larger populations. CONCLUSIONS: Information to support decisions may arise from tools such as decision trees, Markov models, microsimulation models, and dynamic transmission models. These data can help guide choices about competing or alternative approaches to health care. IMPLICATIONS FOR PRACTICE: Methods have been developed to support decisions based on data. Understanding the related techniques may help promote an evidence-based approach to clinical management and policy.

Public health and cost consequences of time delays to thrombectomy for acute ischemic stroke.

OBJECTIVE: To determine public health and cost consequences of time delays to endovascular thrombectomy (EVT) for patients, health care systems, and society, we estimated quality-adjusted life-years (QALYs) of EVT-treated patients and associated costs based on times to treatment. METHODS: The Markov model analysis was performed from US health care and societal perspectives over a lifetime horizon. Contemporary data from 7 trials within the Highly Effective Reperfusion Evaluated in Multiple Endovascular Stroke Trials (HERMES) collaboration served as data source. Aside from cumulative lifetime costs, we calculated the net monetary benefit (NMB) to determine the economic value of care. We used a contemporary willingness-to-pay threshold of $100,000 per QALY for NMB calculations. RESULTS: Every 10 minutes of earlier treatment resulted in an average gain of 39 days (95% prediction interval 23-53 days) of disability-free life. Overall, the cumulative lifetime costs for patients with earlier or later treatment were similar. Patients with later treatment had higher morbidity-related costs but over a shorter time span due to their shorter life expectancy, resulting in similar lifetime costs as in patients with early treatment. Regarding the economic value of care, every 10 minutes of earlier treatment increased the NMB by $10,593 (95% prediction interval $5,549-$14,847) and by $10,915 (95% prediction interval $5,928-$15,356) taking health care and societal perspectives, respectively. CONCLUSIONS: Any time delay to EVT reduces QALYs and decreases the economic value of care provided by this intervention. Health care policies to implement efficient prehospital triage and to accelerate in-hospital workflow are urgently needed.

Public Health and Cost Benefits of Successful Reperfusion After Thrombectomy for Stroke.

Background and Purpose- The benefit that endovascular thrombectomy offers to patients with stroke with large vessel occlusions depends strongly on reperfusion grade as defined by the expanded Thrombolysis in Cerebral Infarction (eTICI) scale. Our aim was to determine the lifetime health and cost consequences of the quality of reperfusion for patients, healthcare systems, and society. Methods- A Markov model estimated lifetime quality-adjusted life years (QALY) and lifetime costs of endovascular thrombectomy-treated patients with stroke based on eTICI grades. The analysis was performed over a lifetime horizon in a United States setting, adopting healthcare and societal perspectives. The reference case analysis was conducted for stroke at 65 years of age. National health and cost consequences of improved eTICI 2c/3 reperfusion rates were estimated. Input parameters were based on best available evidence. Results- Lifetime QALYs increased for every grade of improved reperfusion (median QALYs for eTICI 0/1: 2.62; eTICI 2a: 3.46; eTICI 2b: 5.42; eTICI 2c: 5.99; eTICI 3: 6.73). Achieving eTICI 3 over eTICI 2b reperfusion resulted on average in 1.31 incremental QALYs as well as healthcare and societal cost savings of $10 327 and $20 224 per patient. A 10% increase in the eTICI 2c/3 reperfusion rate of all annually endovascular thrombectomy-treated patients with stroke in the United States is estimated to yield additional 3656 QALYs and save $21.0 million and $36.8 million for the healthcare system and society, respectively. Conclusions- Improved reperfusion grants patients with stroke additional QALYs and leads to long-term cost savings. Procedural strategies to achieve complete reperfusion should be assessed for safety and feasibility, even when initial reperfusion seems to be adequate.

Evidence-Based Medicine in Otolaryngology Part 10: Cost-Effectiveness Analyses in Otolaryngology.

Clinicians seek to pursue the most clinically effective treatment strategies, but costs have also become a key determinant in contemporary health care. Economic analyses have thus emerged as a valuable resource to both quantify and qualify the value of existing and emerging interventions and programs. Cost-effectiveness analyses estimate the benefits gained per monetary unit, providing insights to guide resource allocation. Herein, we delineate the related concepts and considerations to facilitate understanding and appraisal of these analyses, so as to better inform the stakeholders in our otolaryngology community.

Risk of Intracranial Complications in Minor Head Injury: The Role of Loss of Consciousness and Post-Traumatic Amnesia in a Multi-Center Observational Study.

Various guidelines for minor head injury focus on patients with a Glasgow Coma Scale (GCS) score of 13-15 and loss of consciousness (LOC) or post-traumatic amnesia (PTA), while clinical management for patients without LOC or PTA is often unclear. We aimed to investigate the effect of presence and absence of LOC or PTA on intracranial complications in minor head injury. A prospective multi-center cohort study of all patients with blunt head injury and GCS score of 15 was conducted at six Dutch centers between 2015 and 2017. Five centers used the national guideline and one center used a local guideline-both based on the CT in Head Injury Patients (CHIP) prediction model-to identify patients in need of a computed tomography (CT) scan. We studied the presence of traumatic findings and neurosurgical interventions in patients with and without LOC or PTA. In addition, we assessed the association of LOC and PTA with traumatic findings with logistic regression analysis and the additional predictive value of LOC and PTA compared with other risk factors in the CHIP model. Of 3914 patients, 2249 (58%) experienced neither LOC nor PTA and in 305 (8%) LOC and PTA was unknown. Traumatic findings were present in 153 of 1360 patients (11%) with LOC or PTA and in 67 of 2249 patients (3%) without LOC and PTA. Five patients without LOC and PTA had potential neurosurgical lesions and one patient underwent a neurosurgical intervention. LOC and PTA were strongly associated with traumatic findings on CT, with adjusted odds ratios of 2.9 (95% confidence interval [CI] 2.2-3.8) and 3.5 (95% CI 2.7-4.6), respectively. To conclude, patients who had minor head injury with neither LOC nor PTA are at risk of intracranial complications. Clinical guidelines should include clinical management for patients without LOC and PTA, and they should include LOC and PTA as separate risk factors rather than as diagnostic selection criteria.

Management of Reducible Ventral Hernias: Clinical Outcomes and Cost-effectiveness of Repair at Diagnosis Versus Watchful Waiting.

OBJECTIVE: To compare long-term clinical and economic outcomes associated with 3 management strategies for reducible ventral hernia: repair at diagnosis (open or laparoscopic) and watchful waiting. BACKGROUND: There is variability in ventral hernia management. Recent data suggest watchful waiting is safe; however, long-term clinical and economic outcomes for different management strategies remain unknown. METHODS: We built a state-transition microsimulation model to forecast outcomes for individuals with reducible ventral hernia, simulating a cohort of 1 million individuals for each strategy. We derived cohort characteristics (mean age 58 years, 63% female), hospital costs, and perioperative mortality from the Nationwide Inpatient Sample (2003-2011), and additional probabilities, costs, and utilities from the literature. Outcomes included prevalence of any repair, emergent repair, and recurrence; lifetime costs; quality-adjusted life years (QALYs); and incremental cost-effectiveness ratios. We performed stochastic and probabilistic sensitivity analyses to identify parameter thresholds that affect optimal management, using a willingness-to-pay threshold of $50,000/QALY. RESULTS: With watchful waiting, 39% ultimately required repair (14% emergent) and 24% recurred. Seventy per cent recurred with repair at diagnosis. Laparoscopic repair at diagnosis was cost-effective compared with open repair at diagnosis (incremental cost-effectiveness ratio $27,700/QALY). The choice of operative strategy (open vs laparoscopic) was sensitive to cost and postoperative quality of life. When perioperative mortality exceeded 5.2% or yearly recurrence exceeded 19.2%, watchful waiting became preferred. CONCLUSIONS: Ventral hernia repair at diagnosis is very cost-effective. The choice between open and laparoscopic repair depends on surgical costs and postoperative quality of life. In patients with high risk of perioperative mortality or recurrence, watchful waiting is preferred.

Evidence-Based Medicine in Otolaryngology Part 9: Valuing Health Outcomes.

Decisions about resource allocation are increasingly based on value trade-offs between health outcomes and cost. This process relies on comprehensive and standardized definitions of health status that accurately measure the physical, mental, and social well-being of patients across disease states. These metrics, assessed through clinical trials, observational studies, and health surveys, can facilitate the integration of patient preferences into clinical practice. This ninth installment in the Evidence-Based Medicine in Otolaryngology Series is a practical overview of health outcome valuation, as well as the integration of both quality and quantity of life into standardized metrics for health research, program planning, and resource allocation. Tools for measuring preference-based health states, measures of effectiveness, and the application of metrics in economic evaluations are discussed.

External validation of computed tomography decision rules for minor head injury: prospective, multicentre cohort study in the Netherlands.

OBJECTIVE: To externally validate four commonly used rules in computed tomography (CT) for minor head injury. DESIGN: Prospective, multicentre cohort study. SETTING: Three university and six non-university hospitals in the Netherlands. PARTICIPANTS: Consecutive adult patients aged 16 years and over who presented with minor head injury at the emergency department with a Glasgow coma scale score of 13-15 between March 2015 and December 2016. MAIN OUTCOME MEASURES: The primary outcome was any intracranial traumatic finding on CT; the secondary outcome was a potential neurosurgical lesion on CT, which was defined as an intracranial traumatic finding on CT that could lead to a neurosurgical intervention or death. The sensitivity, specificity, and clinical usefulness (defined as net proportional benefit, a weighted sum of true positive classifications) of the four CT decision rules. The rules included the CT in head injury patients (CHIP) rule, New Orleans criteria (NOC), Canadian CT head rule (CCHR), and National Institute for Health and Care Excellence (NICE) guideline for head injury. RESULTS: For the primary analysis, only six centres that included patients with and without CT were selected. Of 4557 eligible patients who presented with minor head injury, 3742 (82%) received a CT scan; 384 (8%) had a intracranial traumatic finding on CT, and 74 (2%) had a potential neurosurgical lesion. The sensitivity for any intracranial traumatic finding on CT ranged from 73% (NICE) to 99% (NOC); specificity ranged from 4% (NOC) to 61% (NICE). Sensitivity for a potential neurosurgical lesion ranged between 85% (NICE) and 100% (NOC); specificity from 4% (NOC) to 59% (NICE). Clinical usefulness depended on thresholds for performing CT scanning: the NOC rule was preferable at a low threshold, the NICE rule was preferable at a higher threshold, whereas the CHIP rule was preferable for an intermediate threshold. CONCLUSIONS: Application of the CHIP, NOC, CCHR, or NICE decision rules can lead to a wide variation in CT scanning among patients with minor head injury, resulting in many unnecessary CT scans and some missed intracranial traumatic findings. Until an existing decision rule has been updated, any of the four rules can be used for patients presenting minor head injuries at the emergency department. Use of the CHIP rule is recommended because it leads to a substantial reduction in CT scans while missing few potential neurosurgical lesions.

Cost-effectiveness of Endovascular Therapy for Acute Ischemic Stroke: A Systematic Review of the Impact of Patient Age.

Purpose To determine the impact of patient age on the cost-effectiveness of endovascular therapy (EVT) in addition to standard care (SC) in large-vessel-occlusion stroke for patients aged 50 to 100 years in the United States. Materials and Methods A decision-analytic Markov model was used to estimate direct and indirect lifetime costs and quality-adjusted life years (QALYs). Age-dependent input parameters were obtained from the literature. Deterministic and probabilistic sensitivity analysis for age at index stroke were used. The willingness-to-pay (WTP) was set to thresholds of $50 000, $100 000, and $150 000 per QALY. The study applied a U.S. setting for health care and societal perspectives. Incremental costs and effectiveness were derived from deterministic and probabilistic sensitivity analysis. Acceptability rates at different WTP thresholds were determined. Results EVT+SC was the dominant strategy in patients aged 50 to 79 years. The highest incremental effectiveness (2.61 QALYs) and cost-savings (health care perspective, $99 555; societal perspective, $146 385) were obtained in 50-year-old patients. In octogenarians (80-89 years), EVT+SC led to incremental QALYs at incremental costs with acceptability rates of more than 85%, more than 99%, and more than 99% at a WTP of $50 000, $100 000, and $150 000 per QALY, respectively. In nonagenarians (90-99 years), acceptability rates at a WTP of $50 000 per QALY dropped but stayed higher than 85% and higher than 95% at thresholds of $100 000 and $150 000 per QALY. Conclusion Using contemporary willingness-to-pay thresholds in the United States, endovascular therapy in addition to standard care reduces lifetime costs for patients up to 79 years of age and is cost-effective for patients aged 80 to 100 years.

Can live music therapy reduce distress and pain in children with burns after wound care procedures? A randomized controlled trial.

OBJECTIVE: Burn wound care procedures are very painful and lead to distress. Live music therapy has shown beneficial effects on distress and pain in specific pediatric patient populations. In this study we measured whether live music therapy has beneficial effects in terms of less distress and pain in children with burns after wound care procedures. METHODS: This randomized assessor-blinded controlled trial (RCT) took place at the burns unit of the Red Cross War Memorial Children's Hospital, Cape Town, South Africa. It included newly admitted inpatients between the ages of 0 and 13 years undergoing their first or second wound care procedures. Excluded were children with a hearing impairment or low level of consciousness. The intervention group received one live music therapy session directly after wound care in addition to standard care. The control group received standard care only. The primary outcome was distress measured with the Observational Scale of Behavioral Distress-revised (OSBD-r). The secondary outcome was pain measured with the COMFORT-behavioral scale (COMFORT-B). In addition, in children older than 5 years self-reported distress with the validated Wong-Baker scale (FACES) and pain with the Faces Pain Scale-Revised (FPS-R) were measured. Patients in both groups were videotaped for three minutes before wound care; during the music therapy or the control condition; and for two minutes thereafter. Two researchers, blinded to the study condition, independently scored the OSBD-r and the COMFORT-B from the video footage before and after music therapy. RESULTS: We included 135 patients, median age 22.6 months (IQR 15.4-40.7 months). Change scores did not significantly differ between the intervention and the control groups for either distress (p=0.53; d=0.11; 95% CI -0.23 to 0.45) or pain (p=0.99; d=0.04; 95% CI -0.30 to 0.38). Self-reported distress in a small group of children (n=18) older than 5 years indicated a significant reduction in distress after live music therapy (p=0.05). CONCLUSIONS: Live music therapy was not found effective in reducing distress and pain in young children after burn wound care. Older children might be more responsive to this intervention.

To share or not to share? Expected pros and cons of data sharing in radiological research.

The aims of this paper are to illustrate the trend towards data sharing, i.e. the regulated availability of the original patient-level data obtained during a study, and to discuss the expected advantages (pros) and disadvantages (cons) of data sharing in radiological research. Expected pros include the potential for verification of original results with alternative or supplementary analyses (including estimation of reproducibility), advancement of knowledge by providing new results by testing new hypotheses (not explored by the original authors) on pre-existing databases, larger scale analyses based on individual-patient data, enhanced multidisciplinary cooperation, reduced publication of false studies, improved clinical practice, and reduced cost and time for clinical research. Expected cons are outlined as the risk that the original authors could not exploit the entire potential of the data they obtained, possible failures in patients' privacy protection, technical barriers such as the lack of standard formats, and possible data misinterpretation. Finally, open issues regarding data ownership, the role of individual patients, advocacy groups and funding institutions in decision making about sharing of data and images are discussed. KEY POINTS: • Regulated availability of patient-level data of published clinical studies (data-sharing) is expected. • Expected benefits include verification/advancement of knowledge, reduced cost/time of research, clinical improvement. • Potential drawbacks include faults in patients' identity protection and data misinterpretation.

Traumatic brain injury in the Netherlands, trends in emergency department visits, hospitalization and mortality between 1998 and 2012.

BACKGROUND: Traumatic brain injury (TBI) is a major cause of morbidity and mortality worldwide. The effects of epidemiological changes such as ageing of the population and increased traffic safety on the incidence of TBI are unknown. OBJECTIVE: The objective of this study was to evaluate trends in TBI-related emergency department (ED) visits, hospitalization and mortality in the Netherlands between 1998 and 2012. DESIGN: This was a retrospective observational, longitudinal study. MAIN OUTCOME MEASURES: The main outcome measures were TBI-related ED visits, hospitalization and mortality. RESULTS: Between 1998 and 2012, there were 500 000 TBI-related ED visits in the Netherlands. In the same period, there were 222 000 TBI-related admissions and 17 000 TBI-related deaths. During this period, there was a 75% increase in ED visits for TBI and a 95% increase for TBI-related hospitalization; overall mortality because of TBI did not change significantly. Despite the overall increase in TBI-related ED visits, this increase was not evenly distributed among age groups or trauma mechanisms. In patients younger than 65 years, a declining trend in ED visits for TBI caused by road traffic accidents was observed. Among patients 65 years or older, ED visits for TBI caused by a fall increased markedly. TBI-related mortality shifted from mainly young (67%) and middle-aged individuals (<65 years) to mainly elderly (63%) individuals (≥65 years) between 1998 and 2012. The conclusions of this study did not change when adjusting for changes in age, sex and overall population growth. CONCLUSION: The incidence of TBI-related ED visits and hospitalization increased markedly between 1998 and 2012 in the Netherlands. TBI-related mortality occurred at an older age. These observations are probably the result of a change in aetiology of TBI, specifically a decrease in traffic accidents and an increase in falls in the ageing population. This hypothesis is supported by our data. However, ageing of the population is not the only cause of the changes observed; the observed changes remained significant when correcting for age and sex. The higher incidence of TBI with a relatively stable mortality rate highlights the importance of clinical decision rules to identify patients with a high risk of poor outcome after TBI.

Total-body CT and MR features of postmortem change in in-hospital deaths.

OBJECTIVES: To evaluate the frequency of total-body CT and MR features of postmortem change in in-hospital deaths. MATERIALS AND METHODS: In this prospective blinded cross-sectional study, in-hospital deceased adult patients underwent total-body postmortem CT and MR followed by image-guided biopsies. The presence of PMCT and PMMR features related to postmortem change was scored retrospectively and correlated with postmortem time interval, post-resuscitation status and intensive care unit (ICU) admittance. RESULTS: Intravascular air, pleural effusion, periportal edema, and distended intestines occurred more frequently in patients who were resuscitated compared to those who were not. Postmortem clotting was seen less often in resuscitated patients (p = 0.002). Distended intestines and loss of grey-white matter differentiation in the brain showed a significant correlation with postmortem time interval (p = 0.001, p<0.001). Hyperdense cerebral vessels, intravenous clotting, subcutaneous edema, fluid in the abdomen and internal livores of the liver were seen more in ICU patients. Longer postmortem time interval led to a significant increase in decomposition related changes (p = 0.026). CONCLUSIONS: There is a wide variety of imaging features of postmortem change in in-hospital deaths. These imaging features vary among clinical conditions, increase with longer postmortem time interval and must be distinguished from pathologic changes.

Bosniak Classification for Complex Renal Cysts Reevaluated: A Systematic Review.

PURPOSE: We systematically evaluated the Bosniak classification system with malignancy rates of each Bosniak category, and assessed the effectiveness related to surgical treatment and oncologic outcome based on recurrence and/or metastasis. MATERIALS AND METHODS: In a systematic review according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement and the QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies) criteria, we selected 39 publications for inclusion in this analysis and categorized them into 1) surgical cohorts-all cysts treated surgically and 2) radiological cohorts-cysts with surgical treatment or radiological followup. RESULTS: A total of 3,036 complex renal cysts were categorized into Bosniak II, IIF, III and IV. In surgical and radiological cohorts pooled estimates showed a malignancy prevalence of 0.51 (0.44, 0.58) in Bosniak III and 0.89 (0.83, 0.92) in Bosniak IV cysts, respectively. Stable Bosniak IIF cysts showed a malignancy rate of less than 1% during radiological followup (surveillance). Bosniak IIF cysts, which showed reclassification to the Bosniak III/IV category during radiological followup (12%), showed malignancy in 85%, comparable to Bosniak IV cysts. The estimated surgical number needed to treat to avoid metastatic disease of Bosniak III and IV cysts was 140 and 40, respectively. CONCLUSIONS: The effectiveness of the Bosniak classification system for complex renal cysts was high in categories II, IIF and IV, but low in category III, and 49% of Bosniak III cysts was overtreated because of a benign outcome. This surgical overtreatment combined with the excellent outcome for Bosniak III cysts may suggest that surveillance is a rational alternative to surgery. This will require further study to assess whether surveillance of Bosniak III cysts will prove safe.