Managing unwarranted variation in hospital care - findings from a regional audit in Norway.

BACKGROUND/AIM: There has been increasing focus and research over the past decades on defining, identifying, visualizing and reducing unwarranted clinical variation in clinical practice. Both clinician-driven initiatives such as the US based "Choosing Wisely" campaign and the top-down driven "Evidence-based intervention programme (EBI)" launched by NHS UK to improve quality of care by reducing unnecessary interventions have shown marginal results. We present the findings from a mixed-methods audit performed to evaluate the compliance by senior hospital leaders of a new regional strategy to reduce unwarranted variation in outcomes and utilization rates. METHODS: Seventy-five mid- to senior-division and department leaders from eight hospital trusts in South-Eastern Norway Regional Trust (HSO) were invited to participate in evaluating the response and compliance of the regional leadership strategy for reducing unwarranted variation in patient outcomes and service utilization rates. RESULTS: The audit revealed that the aim of reducing unwanted variation was not clearly communicated by senior HSO management. There was varying use of data from the national quality registers and health atlases for quality improvement. One third of the clinical leaders reported a lack of scrutiny of their work and were insufficiently aware of the HSO's top-management and the hospital's Boards strategic expectations about the importance of reducing unwarranted variation in their hospital utilization. CONCLUSIONS: We found that the strategic aim of reducing unwanted clinical variation was not clearly communicated by senior HSO management to hospital boards and senior management. The hospitals could benefit from a better understanding of causes of variation by strengthening their efforts to reduce unwarranted variation in utilization rates as a key element in improving health care quality and patient safety. The findings of the audit are relevant for other healthcare organizations trying to improve their quality and reduce unnecessary variation.

Perioperative cardiac function and predictors for adverse events after transmyocardial laser treatment.

BACKGROUND: Previous studies have reported that mortality and morbidity after transmyocardial laser treatment (TML) mainly occur perioperatively. The present study was designed to evaluate left-ventricular function and identify risk factors for cardiac-related adverse events in this phase. METHODS: Forty-nine patients were studied. The inclusion criteria were angina pectoris Canadian Cardiovascular Society Angina Score (CCSAS) class III and IV refractory to medical therapy and untreatable by coronary artery bypass graft or percutaneous transluminal coronary angioplasty, age less than 75 years, left ventricular ejection fraction greater than or equal to 30%, and myocardial regions with reversible ischemia. Hemodynamic data and cardiac adverse events were registered. The follow-up time was 30 days. RESULTS: A transient decrease in mean cardiac index (CI) was observed, reaching its minimum immediately after end of the surgical procedure (1.8+/-0.4, p<0.01 vs. baseline). Two patients (4%) died during the postoperative period (30 days). Seventeen patients (35%) experienced adverse cardiac-related events, where CCSAS class IV, unprotected left main stem stenosis, and diabetes mellitus were identified as risk factors in a multivariate analysis. CONCLUSIONS: A transient impairment of left ventricular function was observed after TML. The morbidity and mortality after TML were almost exclusively cardiac-related, identifying CCSAS class IV, unprotected left main stem stenosis, and diabetes as risk factors.

Transmyocardial laser treatment reduces ischemia-induced ventricular fibrillation during the early phase (1a) after coronary artery occlusion in open chest anesthetized pigs.

INTRODUCTION: It has previously been shown that transmyocardial revascularization with laser (TMR) prior to coronary artery occlusion decreases the occurrence of ischemia-induced arrhythmias. The aim of the present study was to determine the effects of TMR on ventricular fibrillation and other arrhythmias during the early (1a) and late phase (1b) of ischemia in pigs. METHODS: In six pigs TMR was performed in the anterior wall of the left ventricle 60 minutes prior to occlusion of the proximal LAD. Six other pigs were subjected to coronary occlusion without preceding TMR and served as controls. RESULTS: During the 30 min period with LAD occlusion ventricular fibrillation occurred 22 times in 5 of 6 control animals (20 episodes in phase la, 2 in phase 1b), whereas none of the animals subjected to TMR prior to the coronary artery occlusion developed ventricular fibrillation (p<0.01). The total number of premature beats per animal was lower during the early phase (la) after LAD occlusion in the TMR group than in the control group (18+/-13 vs 248+/-82, p<0.05). CONCLUSIONS: TMR prior to occlusion of LAD reduced the occurrence of early phase (la) ischemia-induced ventricular fibrillation and premature beats. This anti-fibrillatory effect might explain the improved survival observed in experimental studies after TMR prior to coronary artery occlusion found by others.

Transmyocardial laser induces coronary hyperemia and reduces ischemia-related arrhythmias, but fails to delay development of myocardial necrosis after coronary artery occlusion in pigs.

BACKGROUND: Several investigators have reported that transmyocardial revascularization (TMR) prior to acute coronary artery occlusion improves regional myocardial function and reduces the infarct size in animals with significant coronary collateral circulation. Whether the protective effect of TMR is due to perfusion through the laser-made channels, increased collateral flow or other mechanisms remains unresolved. The aim of this study was to investigate whether TMR performed prior to acute coronary artery occlusion could offer protection from ischemic injury in the pig, an animal with limited native collateral coronary circulation. METHODS: In one group (n=4), TMR was performed in the anterior wall of the left ventricle 30 minutes prior to occlusion of the proximal LAD for 45 minutes. The other group (n=6) was subjected to transient ischemia of the same duration without previous TMR. Area at risk and infarct size were determined after sacrifice. RESULTS: No significant difference was found in the infarct size between the two groups (69+/-2% in the TMR group versus 62+/-4% in the control group). However, the arrhythmic index during the period of ischemia was significantly lower in the TMR group (1.0+/-0.3 vs 8.3+/-2.2, p<0.001). Blood flow in LAD increased to a maximum of 135+/-6% of baseline level three minutes after the end of the TMR procedure. CONCLUSIONS: TMR failed to reduce the infarct size following acute coronary artery occlusion in the pig, an animal with a small collateral coronary flow capacity, but reduced ischemia-related arrhythmias and increased coronary flow transiently.

Pentobarbital versus medetomidine-ketamine-fentanyl anaesthesia: effects on haemodynamics and the incidence of ischaemia-induced ventricular fibrillation in swine.

The present study was performed to compare haemodynamic variables at baseline and the incidence of ventricular fibrillation during the early phase of ischaemia in swine during pentobarbital or medetomidine-ketamine-fentanyl anaesthesia. Twenty-two swine (mean +/- SD: 29+/- 3 kg) were anaesthetized with sodium pentobarbital (induction with 36 mg/kg intraperitoneally, and maintenance with 5-20 mg/kg/h intravenously [i.v.]) and 6 swine (27+/- 3 kg) were anaesthetized with ketamine and fentanyl (premedicated with medetomidine 0.1 mg/kg and ketamine 10 mg/kg intramuscularly, induction with ketamine 20 mg/kg and fentanyl 0.025 mg/kg i.v., and maintenance with ketamine 20 mg/kg/h and fentanyl 0.025 mg/kg/h i.v.). After a stabilization period of 30 min, the left anterior descending coronary artery (LAD) was occluded for 10 min. Haemodynamic data and occurrence of ventricular fibrillation were recorded. The ischaemic area was measured by fluorescing microspheres. Swine anaesthetized with medetomidine-ketamine-fentanyl had significantly lower heart rate, myocardial contractility, peak left ventricular pressure, arterial blood pressure, aortic blood flow, myocardial blood flow and cardiac index at baseline, than swine anaesthetized with pentobarbital. Whereas none of the swine anaesthetized with pentobarbital fibrillated during the LAD occlusion, ventricular fibrillation occurred in 83% of the animals anaesthetized with medetomidine-ketamine-fentanyl (P< 0.001). No significant difference was found in size of ischaemic area between the two groups. Thus, we show a depression in haemodynamic variables at baseline and a higher incidence of ventricular fibrillation during the early phase of ischaemia in swine anaesthetized with medetomidine-ketamine-fentanyl compared to swine anaesthetized with pentobarbital.

Prospective study of changes in impairments and disabilities after anterior cruciate ligament reconstruction.

STUDY DESIGN: Single-group, repeated-measures prospective study. OBJECTIVES: To analyze changes in impairments and disabilities among patients with anterior cruciate ligament (ACL) reconstruction and to assess the relationships between the impairment and disability outcome measures from 3 months to 2 years following ACL reconstruction. BACKGROUND: Outcomes after ACL reconstruction can be categorized as impairments or disabilities. The relationship between impairments and disabilities may be crucial to understanding physical therapy interventions and predicting long-term outcome. METHODS AND MEASURES: Sixty patients who had undergone ACL reconstruction participated in the study. Impairment measures were range of motion, pain, knee-joint laxity, and muscle performance using isokinetic muscle tests. Disability measures were the Cincinnati knee score and lower limb performance using the triple-jump and stair-hop tests. Follow-up times were 3 and 6 months and 1 and 2 years after surgery. RESULTS: The Cincinnati knee score results show significant improvement 1 year after surgery (84.2 +/- 13.6) compared with 6 months (76.8 +/- 13.7) and 3 months (67.4 +/- 16.3) after surgery. Quadriceps total work (percentage of normal leg) significantly improved 2 years after surgery (92.6 +/- 14.1%) compared with 1 year after surgery (81.6 +/- 16.8%). Between 37 and 75% of the variability in the Cincinnati knee score could be explained by variation in the impairment variables, and quadriceps muscle performance and pain were the most significant predictors of disability. Extension deficit and pain at 3 months were significantly related to the Cincinnati knee score at the 2-year follow-up. CONCLUSIONS: Up to 2 years may be needed to regain normal quadriceps muscle performance following ACL reconstruction. Pain and quadriceps muscle performance explained most of the variability in the Cincinnati knee score.

Effects of autotransfusion of mediastinal shed blood on biochemical markers of myocardial damage in coronary surgery.

BACKGROUND: Previous studies have shown conflicting results regarding the effect of autotransfusion of mediastinal shed blood after coronary artery bypass grafting (CABG) on the serum levels of myocardial band (MB) isoenzymes of creatine kinase (CK-MB) and cardiac troponins. The effect of autotransfusion on serum levels of human heart fatty acid binding protein (H-FABP), another marker of myocardial necrosis, has not been studied. The aim of the present study was to investigate the effects of autotransfusion of mediastinal shed blood on the serum levels of CK-MB, cardiac troponin T (cTnT), and H-FABP after uncomplicated primary CABG. METHODS: Fifty patients were randomized to post-operative autotransfusion of mediastinal shed blood or no autotransfusion. Blood samples for the analysis of the biochemical markers of myocardial damage were drawn pre-operatively and 1, 4, 12, 24, 48, and 72 h after the termination of cardiopulmonary bypass. Samples from the mediastinal shed blood were collected after 1 and 4 h. RESULTS: The levels of the biochemical markers of myocardial injury were all markedly elevated in mediastinal shed blood. Autotransfusion did not significantly affect the serum levels of cTnT or H-FABP. However, during the early post-operative hours, there was a trend towards a higher level of cTnT and H-FABP in the autotransfusion group. During the first 24 h after surgery, the autotransfusion group had a significantly higher serum level of CK-MB. CONCLUSION: Post-operative autotransfusion of mediastinal shed blood may contribute to elevated serum levels of biochemical markers of myocardial injury.

[Placebo effect in research related to surgery and technical procedures]. / Placeboeffekt ved kirurgisk og prosedyrerelatert klinisk forskning.

BACKGROUND: Development of new technology has led to the introduction of many new high-tech surgical treatment modalities. It has been claimed that the use of high-tech medicine is a potent inductor of placebo effect; in fact, many new treatment modalities have been established before they have been evaluated in placebo-controlled trials. However, there are several ways to minimize the confounding effects of placebo in surgical trials. MATERIAL AND METHODS: This is a review based on a thoroughly performed search on Medline of Norwegian and English language publications published up until August 2000. RESULTS: Several studies have demonstrated that surgical treatment induces significant placebo effect. To minimize the confounding effects of placebo in trials evaluating new surgical modalities, it is important to use adequate blinding, neutral patient information, objective end-points, and correction for estimated placebo effects. The use of placebo surgery has been a source of lively controversy; many consider it ethically unacceptable.

[Transmyocardial laser treatment--a new treatment modality in pronounced angina pectoris?]. / Transmyokardial laserbehandling--et nytt tilbud ved uttalt angina pectoris?

Transmyocardial laser treatment is currently being evaluated as a treatment modality for patients with severe coronary artery disease unsuitable for conventional revascularization with percutaneous transluminal coronary angioplasty or coronary artery bypass grafting. The original hypothesis was that laser-made channels could contribute to myocardial perfusion by conducting blood from the left ventricular cavity into the ischemic myocardium. Results from clinical trials suggest that transmyocardial laser treatment leads to a significant decrease in physician-assessed angina scores and improvement of quality of life. There are, however, conflicting data regarding the effect of myocardial perfusion, and the mechanisms responsible for the observed clinical effect remain unclear. It has been suggested that the angina relief is caused by destruction of myocardial peripheral nerve-endings and improved perfusion through induction of angiogenesis and collateral recruitment. A review of transmyocardial laser treatment with emphasis on experimental and clinical results, based on a thoroughly performed search on Medline of English language publications up until May 1999, is presented.

Cardiac enzymes after transmyocardial laser treatment with CO2 laser.

OBJECTIVES: The aim of the present study was to examine postoperative serum levels of cardiac enzymes after transmyocardial laser treatment (TML) and to evaluate any associations between this release, postoperative cardiac events and change in ejection fraction after 3 months' follow-up. DESIGN: Forty-nine patients with angina pectoris Canadian Cardiovascular Society Angina Score Class III & IV refractory to medical therapy and untreatable by coronary artery bypass or percutaneous transluminal angioplasty treated with CO2 laser were included. Inclusion criteria were age less than 75 years, left ventricular ejection fraction greater than or equal to 30% and myocardial regions with reversible ischemia. Serum levels of aspartate aminotranspherase (ASAT), alanine aminotranspherase (ALAT) and MB-isoenzymes of creatine kinase (CK-MB) were followed during the first 72 h after surgery. Ejection fractions were estimated by multiple-gated acquisition ventriculography at inclusion and 3 months postoperatively. RESULTS: A significant increase in serum markers of myocardial necrosis was observed 8 h after surgery. A subsequent increase from 8 to 24 h after surgery was associated with the presence of postoperative cardiac adverse events. An inverse correlation was found between peak level of cardiac enzymes and change in ejection fraction from baseline to 3 months' follow-up. CONCLUSIONS: TML with CO2 laser is followed by a significant increase in serum levels of cardiac enzymes after 8 h. Further significant increases are associated with cardiac adverse events postoperatively. Peak enzyme values are inversely correlated with change in ejection fraction from baseline to 3 months' follow-up.