Economic evaluation of antibiotic therapy versus appendicectomy for the treatment of uncomplicated acute appendicitis from the APPAC randomized clinical trial

2017 ◽  
Vol 104 (10) ◽  
pp. 1355-1361 ◽  
Author(s):  
S. Sippola ◽  
J. Grönroos ◽  
R. Tuominen ◽  
H. Paajanen ◽  
T. Rautio ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Economic Evaluation ◽  
Acute Appendicitis ◽  
Antibiotic Therapy ◽  
Randomized Clinical Trial ◽  
Uncomplicated Acute Appendicitis

scholarly journals Five-Year Follow-up of Antibiotic Therapy for Uncomplicated Acute Appendicitis in the APPAC Randomized Clinical Trial

JAMA ◽  
2018 ◽  
Vol 320 (12) ◽  
pp. 1259 ◽  
Author(s):  
Paulina Salminen ◽  
Risto Tuominen ◽  
Hannu Paajanen ◽  
Tero Rautio ◽  
Pia Nordström ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Acute Appendicitis ◽  
Antibiotic Therapy ◽  
Randomized Clinical Trial ◽  
Uncomplicated Acute Appendicitis

scholarly journals A randomised placebo-controlled double-blind multicentre trial comparing antibiotic therapy with placebo in the treatment of uncomplicated acute appendicitis: APPAC III trial study protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (11) ◽  
pp. e023623 ◽  
Author(s):  
Suvi Sippola ◽  
Juha Grönroos ◽  
Ville Sallinen ◽  
Tero Rautio ◽  
Pia Nordström ◽  
...  
Keyword(s):  
Acute Appendicitis ◽  
Antibiotic Therapy ◽  
Ct Scan ◽  
Symptomatic Treatment ◽  
Spontaneous Resolution ◽  
University Hospital ◽  
Controlled Study ◽  
Double Blind ◽  
Uncomplicated Acute Appendicitis

IntroductionRecent studies show that antibiotic therapy is safe and feasible for CT-confirmed uncomplicated acute appendicitis. Spontaneous resolution of acute appendicitis has already been observed over a hundred years ago. In CT-confirmed uncomplicated acute diverticulitis (left-sided appendicitis), studies have shown no benefit from antibiotics compared with symptomatic treatment, but this shift from antibiotics to symptomatic treatment has not yet been widely implemented in clinical practice. Recently, symptomatic treatment of uncomplicated acute appendicitis has been demonstrated in a Korean open-label study. However, a double-blinded placebo-controlled study to illustrate the role of antibiotics and spontaneous resolution of uncomplicated acute appendicitis is still lacking.Methods and analysisThe APPAC III (APPendicitis ACuta III) trial is a multicentre, double-blind, placebo-controlled, superiority randomised study comparing antibiotic therapy with placebo in the treatment CT scan-confirmed uncomplicated acute appendicitis aiming to evaluate the role of antibiotics in the resolution of uncomplicated acute appendicitis. Adult patients (18–60 years) with CT scan-confirmed uncomplicated acute appendicitis (the absence of appendicolith, abscess, perforation and tumour) will be enrolled in five Finnish university hospitals.Primary endpoint is success of the randomised treatment, defined as resolution of acute appendicitis resulting in discharge from the hospital without surgical intervention within 10 days after initiating randomised treatment (treatment efficacy). Secondary endpoints include postintervention complications, recurrent symptoms after treatment up to 1 year, late recurrence of acute appendicitis after 1 year, duration of hospital stay, sick leave, treatment costs and quality of life. A decrease of 15 percentage points in success rate is considered clinically important difference. The superiority of antibiotic treatment compared with placebo will be analysed using Fisher’s one-sided test and CI will be calculated for proportion difference.Ethics and disseminationThis protocol has been approved by the Ethics Committee of Turku University Hospital and the Finnish Medicines Agency (FIMEA). The findings will be disseminated in peer-reviewed academic journals.Trial registration numberNCT03234296; Pre-results.

Simulation Modeling as a Decision-Making Aid in Economic Evaluation for Randomized Clinical Trials

2011 ◽  
pp. 1738-1758
Author(s):  
Tillal Eldabi ◽  
Robert D. Macredie ◽  
Ray J. Paul
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Economic Evaluation ◽  
Simulation Model ◽  
Randomized Clinical Trial ◽  
Simulation Modeling ◽  
Randomized Clinical Trials ◽  
Healthcare Systems ◽  
Modeling Process

This chapter reports on the use of simulation in supporting decision-making about what data to collect in a randomized clinical trial (RCT). We show how simulation also allows the identification of critical variables in the RCT by measuring their effects on the simulation model’s “behavior.” Healthcare systems pose many of the challenges, including difficulty in understanding the system being studied, uncertainty over which data to collect, and problems of communication between problem owners. In this chapter we show how simulation also allows the identification of critical variables in the RCT by measuring their effects on the simulation model’s “behavior.” The experience of developing the simulation model leads us to suggest simple but extremely valuable lessons. The first relates to the inclusion of stakeholders in the modeling process and the accessibility of the resulting models. The ownership and confidence felt by stakeholders in our case is, we feel, extremely important and may provide an example to others developing models.

scholarly journals Quality of Life and Patient Satisfaction at 7-Year Follow-up of Antibiotic Therapy vs Appendectomy for Uncomplicated Acute Appendicitis

JAMA Surgery ◽  
2020 ◽  
Vol 155 (4) ◽  
pp. 283 ◽  
Author(s):  
Suvi Sippola ◽  
Jussi Haijanen ◽  
Lauri Viinikainen ◽  
Juha Grönroos ◽  
Hannu Paajanen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Patient Satisfaction ◽  
Acute Appendicitis ◽  
Antibiotic Therapy ◽  
Uncomplicated Acute Appendicitis
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