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1.  A multicenter randomized clinical trial investigating the cost-effectiveness of treatment strategies with or without antibiotics for uncomplicated acute diverticulitis (DIABOLO trial) 
BMC Surgery  2010;10:23.
Background
Conservative treatment of uncomplicated or mild diverticulitis usually includes antibiotic therapy. It is, however, uncertain whether patients with acute diverticulitis indeed benefit from antibiotics. In most guidelines issued by professional organizations antibiotics are considered mandatory in the treatment of mild diverticulitis. This advice lacks evidence and is merely based on experts' opinion. Adverse effects of the use of antibiotics are well known, including allergic reactions, development of bacterial resistance to antibiotics and other side-effects.
Methods
A randomized multicenter pragmatic clinical trial comparing two treatment strategies for uncomplicated acute diverticulitis. I) A conservative strategy with antibiotics: hospital admission, supportive measures and at least 48 hours of intravenous antibiotics which subsequently are switched to oral, if tolerated (for a total duration of antibiotic treatment of 10 days). II) A liberal strategy without antibiotics: admission only if needed on clinical grounds, supportive measures only. Patients are eligible for inclusion if they have a diagnosis of acute uncomplicated diverticulitis as demonstrated by radiological imaging. Only patients with stages 1a and 1b according to Hinchey's classification or "mild" diverticulitis according to the Ambrosetti criteria are included. The primary endpoint is time-to-full recovery within a 6-month follow-up period. Full recovery is defined as being discharged from the hospital, with a return to pre-illness activities, and VAS score below 4 without the use of daily pain medication. Secondary endpoints are proportion of patients who develop complicated diverticulitis requiring surgery or non-surgical intervention, morbidity, costs, health-related quality of life, readmission rate and acute diverticulitis recurrence rate. In a non-inferiority design 264 patients are needed in each study arm to detect a difference in time-to-full recovery of 5 days or more with a power of 85% and a confidence level of 95%. With an estimated one percent of patients lost to follow up, a total of 533 patients will be included.
Conclusion
A clinically relevant difference of more than 5 days in time-to-full recovery between the two treatment strategies is not expected. The liberal strategy without antibiotics and without the strict requirement for hospital admission is anticipated to be more a more cost-effective approach.
Trial registration
Trial registration number: NCT01111253
doi:10.1186/1471-2482-10-23
PMCID: PMC2919453  PMID: 20646266
2.  Costs of relaparotomy on-demand versus planned relaparotomy in patients with severe peritonitis: an economic evaluation within a randomized controlled trial 
Critical Care  2010;14(3):R97.
Introduction
Results of the first randomized trial comparing on-demand versus planned-relaparotomy strategy in patients with severe peritonitis (RELAP trial) indicated no clear differences in primary outcomes. We now report the full economic evaluation for this trial, including detailed methods, nonmedical costs, further differentiated cost calculations, and robustness of different assumptions in sensitivity analyses.
Methods
An economic evaluation was conducted from a societal perspective alongside a randomized controlled trial in 229 patients with severe secondary peritonitis and an acute physiology and chronic health evaluation (APACHE)-II score ≥11 from two academic and five regional teaching hospitals in the Netherlands. After the index laparotomy, patients were randomly allocated to an on-demand or a planned-relaparotomy strategy. Primary resource-utilization data were used to estimate mean total costs per patient during the index admission and after discharge until 1 year after the index operation. Overall differences in costs between the on-demand relaparotomy strategy and the planned strategy, as well as relative differences across several clinical subgroups, were evaluated.
Results
Costs were substantially lower in the on-demand group (mean, €65,768 versus €83,450 per patient in the planned group; mean absolute difference, €17,682; 95% CI, €5,062 to €29,004). Relative differences in mean total costs per patient (approximately 21%) were robust to various alternative assumptions. Planned relaparotomy consistently generated more costs across the whole range of different courses of disease (quick recovery and few resources used on one end of the spectrum; slow recovery and many resources used on the other end). This difference in costs between the two surgical strategies also did not vary significantly across several clinical subgroups.
Conclusions
The reduction in societal costs renders the on-demand strategy a more-efficient relaparotomy strategy in patients with severe peritonitis. These differences were found across the full range of healthcare resources as well as across patients with different courses of disease.
Trial Registration
ISRCTN51729393
doi:10.1186/cc9032
PMCID: PMC2911734  PMID: 20507557
3.  Antibiotics and steroids for exacerbations of COPD in primary care: compliance with Dutch guidelines 
Background
The Dutch College of General Practitioners' guidelines specify that antibiotics should only be used for severe cases of chronic obstructive pulmonary disease (COPD). However, GPs tend to administer antibiotics rather than a short course of steroid treatment regardless of severity.
Aim
The aim of this study was to determine how GPs use current guidelines in treating exacerbations of COPD, in particular whether short courses of oral steroids and antibiotics are prescribed in accordance with the Dutch guidelines for COPD.
Design of study
Retrospective analysis of medical records.
Setting
Primary healthcare centres.
Method
Medical records of patients registered at four primary healthcare centres in the Netherlands were retrospectively analysed for the period March 2001–March 2003.
Results
Of 35 589 patients, 1.3% were registered as having a diagnosis of COPD. In 2 years, 47% of the patients had no exacerbation, 35% had one or two exacerbations, and 18% had three or more exacerbations. Of 536 exacerbations, GPs prescribed a short course of oral steroids in 30% of cases, antibiotics in 29%, steroids combined with an antibiotic in 23%, and no oral steroid course or antibiotic was prescribed in 18%. Prescriptions for patients with three or more exacerbations differed significantly from those for patients with one or two exacerbations.
Conclusions
Treatment is often not in accordance with current guidelines; in particular, antibiotics are prescribed more often than recommended.
PMCID: PMC1876631  PMID: 16953997
antibiotics; COPD; exacerbation; primary health care; steroids

Results 1-3 (3)