Systematic reviews and accompanying meta-analyses are the cornerstones of evidence-based medicine. Systematic reviews summarize clinical evidence; meta-analyses provide summary estimates of the ...treatment effect or the diagnostic test accuracy. Although deemed to provide the highest level of evidence, their clinical value is limited as they can only summarize aggregated data. In these meta-analyses the true variability of the treatment effects cannot be explored to the desired extent, because the meta-analyses cannot distinguish between patients with different clinical profiles. Systematic reviews and meta-analyses based on individual patient data (IPD), described as the ‘gold standard’ for systematic reviews are a promising approach that might overcome these limitations. IPD meta-analyses allow treatment effects and diagnostic accuracy to be estimated at the level of relevant patient subgroups. This enables researchers to investigate the effectiveness of treatment in patients with different profiles. In this article, we address the opportunities of systematic reviews and meta-analyses using IPD in reproductive medicine. We discuss its potential based on three clinical examples: single versus double embryo transfer in IVF, the diagnosis of tubal pathology and the prognostic value of ovarian reserve tests. We propose to show potential advantages of IPD systematic reviews and meta-analyses in providing stratified clinical evidence, which could improve medical care.
Recommended therapy duration for patients hospitalized with cellulitis is 10-14 days. Unnecessary use of antibiotics is one of the key factors driving resistance. Recent studies have shown that ...antibiotic therapy for cellulitis in outpatients can safely be shortened, despite residual inflammation. This study will compare in hospitalized patients the safety and effectiveness of shortening antibiotic therapy for cellulitis from 12 to 6 days.
In a multicenter, randomized, double-blind, non-inferiority trial, adult patients admitted with cellulitis will be included. Cellulitis is defined as warmth, erythema, and induration of the skin and/or subcutaneous tissue, with or without pain (including erysipelas). All patients will initially be treated with intravenous flucloxacillin, and will be evaluated after 5-6 days. Those who have improved substantially (defined as being afebrile, and having a lower cellulitis severity score) will be randomized at day 6 between additional 6 days of oral flucloxacillin (n = 198) or placebo (n = 198). Treatment success is defined as resolution of cellulitis on day 14 (disappearance of warmth and tenderness, improvement of erythema and edema), without the need of additional antibiotics for cellulitis by day 28. Secondary endpoints are relapse rate (up to day 90), speed of recovery (using a cellulitis severity score until day 28, and VAS scores on pain and swelling until day 90), quality of life (using the SF-36 and EQ-5D questionnaires) and costs (associated with total antibiotic use and health-care resource utilization up to day 90).
Inclusion is planned to start in Q2 2014.
ClinicalTrials.gov (NCT02032654) and the Netherlands Trial Register (NTR4360).
The two most common interventions for Posttraumatic Stress Disorder (PTSD) are pharmacological treatment with SSRIs such as paroxetine and psychological treatment such as Trauma-Focused Cognitive ...Behavioral Therapy (TF-CBT). International guidelines recommend trauma-focused psychological interventions for all PTSD patients as first-line treatment (NICE). However, no clear-cut evidence is available to support this recommendation.
In order to compare pharmacological treatment (paroxetine) and psychological treatment (TF-CBT) in (cost-) effectiveness on the short and the long term, we will randomize 90 patients with chronic PTSD to either paroxetine (24 weeks) or TF-CBT (10-12 weeks). We will assess symptom severity and costs before and after the intervention with the Clinician Administered PTSD Scale (CAPS), the Clinical Global Impression Scale (CGI) and the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P).
This study is unique for its direct comparison of the most commonly used psychological intervention (TF-CBT) and pharmacological intervention (paroxetine) on (cost-) effectiveness on the short and the long term. The anticipated results will provide relevant evidence concerning long-term effects and relapse rates and will be beneficial in reducing societal costs. It may also provide information on who may benefit most from which type of intervention. Some methodological issues will be discussed.
Dutch Trial registration: NTR2235.
Abstract Objective To determine and compare the diagnostic accuracy of the lecithin/sphingomyelin (L/S) ratio and lamellar body count (LBC) in the prediction of neonatal respiratory distress syndrome ...(RDS). Study design A systematic review was performed to identify studies comparing either the L/S ratio or the LBC with the occurrence of RDS published between January 1999 and February 2009. Two independent reviewers performed study selection and data extraction. For each study sensitivity and specificity were calculated. Summary receiver-operating characteristics (ROC) curves, assessing the diagnostic performance of both tests, were constructed. A subgroup analysis was performed to estimate the sensitivity and specificity of the various cut-off values. Results 13 studies were included. The ROC curves of the collected data illustrate that the LBC and L/S ratio perform equally well in the prediction of RDS. Comparison of the two summary ROC curves of each test indicates that the diagnostic performance of LBC might even have a slight advantage over L/S ratio. Due to the wide cut-off range it was not possible to define specific cut-off values with the best accuracy. Conclusion We recommend replacing the L/S ratio as gold standard with the lamellar body count since the LBC is easy to perform, rapid, inexpensive, and available to all hospitals 24 h per day.
eHealth can improve healthcare worldwide, and scientific research should provide evidence on the efficacy, safety and added value of such interventions. For successful implementation of eHealth ...interventions into clinical practice, barriers need to be anticipated. We identified seven barriers by interviewing health professionals in the Dutch healthcare system. These barriers covered three topics: financing, human factors and organizational factors. This paper discusses their potential impact on eHealth uptake. Bridging the gap between studies to assess effective eHealth interventions and their value-based implementation in healthcare is much needed.
Urinary and (peripheral and central) intravenous catheters are widely used in hospitalized patients. However, up to 56% of the catheters do not have an appropriate indication and some serious ...complications with the use of these catheters can occur. The main objective of our quality improvement project is to reduce the use of catheters without an appropriate indication by 25-50%, and to evaluate the affecting factors of our de-implementation strategy.
In a multicenter, prospective interrupted time series analysis, several interventions to avoid inappropriate use of catheters will be conducted in seven hospitals in the Netherlands. Firstly, we will define a list of appropriate indications for urinary and (peripheral and central) intravenous catheters, which will restrict the use of catheters and urge catheter removal when the indication is no longer appropriate. Secondly, after the baseline measurements, the intervention will take place, which consists of a kick-off meeting, including a competitive feedback report of the baseline measurements, and education of healthcare workers and patients. Additional strategies based on the baseline data and local conditions are optional. The primary endpoint is the percentage of catheters with an inappropriate indication on the day of data collection before and after the de-implementation strategy. Secondary endpoints are catheter-related infections or other complications, catheter re-insertion rate, length of hospital (and ICU) stay and mortality. In addition, the cost-effectiveness of the de-implementation strategy will be calculated.
This study aims to reduce the use of urinary and intravenous catheters with an inappropriate indication, and as a result reduce the catheter-related complications. If (cost-) effective it provides a tool for a nationwide approach to reduce catheter-related infections and other complications.
Dutch trial registry: NTR6015 . Registered 9 August 2016.
Abstract Objective To evaluate the cost-effectiveness of a diagnostic laparoscopy prior to primary cytoreductive surgery to prevent futile primary cytoreductive surgery (i.e. leaving > 1 cm residual ...disease) in patients suspected of advanced stage ovarian cancer. Methods An economic analysis was conducted alongside a randomized controlled trial in which patients suspected of advanced stage ovarian cancer who qualified for primary cytoreductive surgery were randomized to either laparoscopy or primary cytoreductive surgery. Direct medical costs from a health care perspective over a 6-month time horizon were analyzed. Health outcomes were expressed in quality-adjusted life-years (QALYs) and utility was based on patient's response to the EQ-5D questionnaires. We primarily focused on direct medical costs based on Dutch standard prices. Results We studied 201 patients, of whom 102 were randomized to laparoscopy and 99 to primary cytoreductive surgery. No significant difference in QALYs (utility = 0.01; 95% CI 0.006 to 0.02) was observed. Laparoscopy reduced the number of futile laparotomies from 39% to 10%, while its costs were € 1400 per intervention, making the overall costs of both strategies comparable (difference € − 80 per patient (95% CI − 470 to 300)). Findings were consistent across various sensitivity analyses. Conclusion In patients with suspected advanced stage ovarian cancer, a diagnostic laparoscopy reduced the number of futile laparotomies, without increasing total direct medical health care costs, or adversely affecting complications or quality of life.
The long-term outcomes of patients with community-acquired pneumonia (CAP) in terms of symptom resolution and health-related quality of life (HRQL) is unknown. Our objective was to determine the rate ...of symptom resolution using validated patient-based outcome measures, and to assess HRQL 18 months after the episode.
Patients were recruited from a group enrolled in a randomized trial comparing two durations of treatment for CAP. Between 2000 and 2003, we included 102 adults with a mild-to-moderate-severe CAP (pneumonia severity index, ≤ 110).
CAP-related symptoms were assessed until month 18 using the CAP score. The CAP score was divided into respiratory and well-being sections to assess the recovery of respiratory and well-being symptoms separately. The HRQL was assessed at 18 months using the Medical Outcomes Study 36-item short form (SF-36) questionnaire and compared to a Dutch reference group.
Respiratory symptoms resolved within 14 days, while the well-being symptoms resolved more slowly. Taking the prepneumonia status into account, patients recovered fully from pneumonia after 6 months. Patients with comorbid conditions had significantly more symptoms prepneumonia and during follow-up than patients without comorbidities, but at all time points the proportion of patients that reached ≥ 80% of the prepneumonia health level did not depend on comorbidity, age, or etiology. SF-36 scores at 18 months were significantly impaired in four of the eight dimensions for patients with comorbid illness, but did not differ from the reference population for patients without comorbid illness.
Patients with mild-to-moderate-severe CAP recover fully from pneumonia after 6 months. The presence of symptoms beyond 28 days and any impairment in HRQL were found to reflect age and comorbidity rather than the persistent effects of the pneumonia itself.
Objective
To determine which doctor‐ and patient‐related factors affect failure of outpatient endometrial sampling in women with postmenopausal bleeding, and to develop a multivariable prediction ...model to select women with a high probability of failed sampling.
Design
Prospective multicenter cohort study.
Setting
Three teaching hospitals in the Netherlands.
Population
Women presenting with postmenopausal bleeding with an indication for endometrial sampling.
Methods
Multivariable logistic regression was performed to evaluate the impact of doctor's training level and patient's characteristics on failure of sampling.
Main outcome measures
Failure of endometrial sampling, classified as technical failure or insufficient tissue for diagnosis.
Results
In 74 (20.8%) of the 356 included women, sampling technically failed, and in 84 (29.8%) the amount of tissue was insufficient for diagnosis. Nulliparity odds ratio (OR) 3.8, 95% confidence interval (CI) 1.8–7.9 and advanced age (OR 1.03 per year, 95% CI 1.00–1.06) were associated with technical failure. Advanced age was associated with insufficient sampling (OR 1.04 per year, 95% CI 1.01–1.07), and endometrial thickness >12 mm decreased the chance of insufficient sampling (OR 0.3, 95%CI 0.1–0.8). The prediction model for total failure had an area under the ROC curve of 0.64 (95% CI 0.58–0.70).
Conclusions
In women with postmenopausal bleeding, the failure rate of endometrial sampling is relatively high and is associated with nulliparity and advanced age. Endometrial thickness >12 mm decreased the chance of failure. A multivariable prediction model for total failure based on patient characteristics has a moderate capacity to discriminate between women at high or low risk of failure.
Objective: Electronic foetal monitoring (EFM) together with non-invasive ST-analysis (STAN) has been suggested as a superior technique to EFM alone for foetal surveillance to prevent metabolic ...acidosis. This study aims to compare the cost-effectiveness of these two techniques from both maternal (short term) as neonatal (long term) perspective to guide clinical decision-making.
Methods: We created two models: a maternal model, focused on the difference in mode of delivery as most important outcome, and a neonatal Markov model focused on the differences in metabolic acidosis - and its relationship to cerebral palsy (CP) - as the most relevant outcome to estimate the long-term cost-effectiveness. The cost to prevent one instrumental delivery was estimated in the maternal model. The costs to prevent one metabolic acidosis and the costs per quality adjusted life years were calculated in the neonatal model.
Results: The average costs of STAN are only €34 higher when compared to EFM alone. From maternal perspective the cost of preventing one instrumental delivery was estimated at €2602. From neonatal perspective the cost to prevent one case of metabolic acidosis was €14 509. Over the long term, STAN becomes a dominant (cost saving) strategy if >1% of the patients exposed to metabolic acidosis acquire CP.
Conclusions: Our study suggests that STAN, when compared to EFM alone, can be a cost-effective strategy from both a maternal and neonatal perspective.
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