Karin Bäckman

Non-randomised patients in a cholecystectomy trial : characteristics, procedures, and outcomes.

BackgroundLaparoscopic cholecystectomy is now considered the first option for gallbladder surgery. However, 20% to 30% of cholecystectomies are completed as open operations often on elderly and fragile patients. The external validity of randomised trials comparing mini-laparotomy cholecystectomy and laparoscopic cholecystectomy has not been studied. The aim of this study is to analyse characteristics, procedures, and outcomes for all patients who underwent cholecystectomy without being included in such a trial.MethodsCharacteristics (age, sex, co-morbidity, and ASA-score), operation time, hospital stay, and mortality were compared for patients who underwent cholecystectomy outside and within a randomised controlled trial comparing mini-laparotomy and laparoscopic cholecystectomy.ResultsDuring the inclusion period 1719 patients underwent cholecystectomy. 726 patients were randomised and 724 of them completed the trial; 993 patients underwent cholecystectomy outside the trial. The non-randomised patients were older – and had more complications from gallstone disease, higher co-morbidity, and higher ASA – score when compared with trial patients. They were also more likely to undergo acute surgery and they had a longer postoperative hospital stay, with a median 3 versus 2 days (p < 0.001 for all comparisons). Standardised mortality ratio within 90 days of operation was 3.42 (mean) (95% CI 2.17 to 5.13) for non-randomised patients and 1.61 (mean) (95%CI 0.02 to 3.46) for trial patients. For non-randomised patients, operation time did not differ significantly between mini-laparotomy and open cholecystectomy in multivariate analysis. However, the operation for laparoscopic cholecystectomy lasted 20 minutes longer than open cholecystectomy. Hospital stay was significantly shorter for both mini-laparotomy and laparoscopic cholecystectomy compared to open cholecystectomy.ConclusionNon-randomised patients were older and more sick than trial patients. The assignment of healthier patients to trials comparing mini-laparotomy cholecystectomy and laparoscopic cholecystectomy limits the external validity of conclusions reached in such trials.

Deep venous thrombosis: a new task for primary health care A randomised economic study of outpatient and inpatient treatment

Objective A health economic evaluation of two alternative treatment settings, inpatient care and outpatient care, for acute deep venous thrombosis. Design A randomised multicentre trial in a defined population in regular clinical practice. Setting Hospitals and related health care centres in the Jönköping county council in Sweden. Interventions Patients were randomised to either an inpatient strategy (n=66) or an outpatient strategy (n=65) using low-molecular-weight heparin, dalteparin, administered subcutaneously once daily and adjusted for body weight. Subjects Of 224 eligible patients, 131 entered the trial and 124 completed the economic part of the study. Main outcome measures Direct medical and direct non-medical costs during a 3-month period. Results Total direct costs were higher for those in the inpatient strategy group, i.e. Swedish Crowns (SEK) 16 400 per patient (Euro 1899) compared to SEK 12 100 per patient (Euro 1405) in the outpatient strategy group (p<0.001). More patients in the outpatient group received assistance when they returned home. Few patients in either group reported sick leave. There was no difference in total number of days between the two groups. Conclusions Total direct costs were significantly lower for the outpatient treatment strategy for deep venous thrombosis compared to the inpatient treatment strategy. No significant difference in health impact could be detected. Deep venous thrombosis can to a greater extent than previously be treated in primary care, safely, at a lower cost, and in accordance with patient preferences.

Formal priority setting in health care: the Swedish experience

Purpose From the late 1980s and onwards health care in Sweden has come under increasing financial pressure, forcing policy makers to consider restrictions. The purpose of this paper is to review experiences and to establish lessons of formal priority setting in four Swedish regional health authorities during the period 2003-2012. Design/methodology/approach This paper draws on a variety of sources, and evidence is organised according to three broad aspects: design and implementation of models and processes, application of evidence and decision analysis tools and decision making and implementation of decisions. Findings The processes accounted for here have resulted in useful experiences concerning technical arrangements as well as political and public strategies. All four sites used a particular model for priority setting that combined top-down- and bottom-up-driven elements. Although the process was authorised from the top it was clearly bottom-up driven and the template followed a professional rationale. New meeting grounds were introduced between politicians and clinical leaders. Overall a limited group of stakeholders were involved. By defusing political conflicts the likelihood that clinical leaders would regard this undertaking as important increased. Originality/value One tendency today is to unburden regional authorities of the hard decisions by introducing arrangements at national level. This study suggests that regional health authorities, in spite of being politically governed organisations, have the potential to execute a formal priority-setting process. Still, to make priority-setting processes more robust to internal as well as external threat remains a challenge.