Quality system based on the standard SFS-EN ISO 9002 in Kuopio University Hospital.

Kuopio University Hospital, situated within middle-east Finland, adopted the ISO 9002 standard as its quality system and gained formal certification in March 1999. The rationale behind the decision to adopt ISO 9002 is given, along with the main elements of the journey. The experiences of the hospital, including the advantages and disadvantages, are explained. In particular, issues regarding the documentation process, control and calibration of 4,000 pieces of medical equipment and the impact on staffing levels for in-house trained personnel to undertake the audits are described. The impact on the service to date, including benefits and drawbacks, is covered, along with aspirations for the future. Kuopio Hospitals adopted some techniques during the implementation process which did not work as successfully as others. The article therefore includes these in an effort to pass on the learning acquired from implementing ISO 9002 within such a large hospital as Kuopio University Hospital.

Procaine (Gerovital): no effect on the rehabilitation result in patients with back or hip disease.

Gerovital was compared with placebo and another procaine preparation in a double blind study of 88 rehabilitation patients suffering from back or hip disease. In an open part of the study procaine from intramuscularly injected Gerovital disappeared from the plasma within 15-30 minutes. In patients treated with Gerovital or another procaine no clinical, physiological or psychological benefits were found in addition to the improvements following rehabilitation compared with placebo treatment. Clinical examination showed that the benefits of rehabilitation were similar in patients receiving Gerovital, another procaine and placebo.

Lisinopril: dose-peak effect relationship in essential hypertension.

1. The dose-peak effect relationship of lisinopril was evaluated in a double-blind, parallel study in 83 patients with mild to moderate essential hypertension (supine diastolic blood pressure = 95-115 mm Hg). 2. After a 4 week placebo washout, patients were randomly assigned to one of four treatments: lisinopril 2.5, 10, 20 or 80 mg day-1 for 1 week. 3. Lisinopril 10 and 20 mg day-1 produced similar peak antihypertensive effects which were greater than that produced by 2.5 mg day-1, but less than that of 80 mg day-1. If the incidence of first-dose symptomatic hypotension is related to the peak effect, then an initial lisinopril dose of 20 mg should not pose any greater risk than a 10 mg dose. 4. The magnitude of antihypertensive response at 24 h postdrug appeared to be dose related across the 2.5 to 80 mg day-1 range.

Effect of omega-3 fatty acid supplementation on platelet aggregability and platelet produced thromboxane.

We investigated the sustained effect of 12-week supplementation of 2.880 g/day of omega-3 fatty acids on platelet aggregability, platelet produced thromboxane B2 concentration and serum fatty acid composition in a double-blind controlled trial in 44 healthy mildly overweight eastern Finnish men recruited from a representative population sample. The supplementation was discontinued seven days before the biochemical measurements. Body weight, alcohol consumption and dietary composition remained constant during the study. Even though the percentage of eicosapentaenoic acid (20:5 omega 3) in total serum lipids increased by 37% (p less than 0.01) and that of dihomo-gamma-linolenic acid (20:3 omega 6) decreased by 18% (p less than 0.01) more in the omega-3 supplemented than placebo group during supplementation, there were no significant differences in the changes in either the ADP induced platelet aggregation or in vitro platelet produced thromboxane B2 concentration between the groups. These data suggest that omega-3 fatty acids have no detectable sustained effect either on ADP induced platelet aggregation or on thromboxane produced by the platelets in vitro.

Inhibition of platelet aggregability by moderate-intensity physical exercise: a randomized clinical trial in overweight men.

It has been postulated that platelet function plays an important role in the initiation of atherosclerosis. Currently there are no definitive data on the longer-term effects of regular physical exercise on platelet function in humans. We assessed the influence of regular moderate-intensity physical exercise (brisk walking to slow jogging) on platelet aggregation in a population-based sample of middle-aged, overweight, mildly hypertensive men in eastern Finland. In this controlled study, we evaluated the net effect of exercise on platelet aggregation by studying changes in optical density and ATP release in platelet-rich plasma. A significant inhibition of secondary platelet aggregation from 27% to 36% was observed in the men taking regular exercise. These findings give new insight into the possible protective effects of exercise against the risk of ischemic heart disease.

Changes occurring in the postinfarction ECG in relation to age, sex, and previous myocardial infarction.

Minnesota codes (MC), expressing Q-QS, ST segment, and T wave abnormalities in ECGs taken during the acute event and at a 1-year follow-up were studied in 256 survivors of myocardial infarction (MI). On the 1-year ECGs large Q waves (MC 1.1) were more common in patients with a history of previous MI than in those with a first MI. Regression of Q-QS, ST segment, and T wave changes occurred more extensively in first MIs, whereas progression of MC Q-QS and ST segment signs tended to be common in those with recurrent MI. On the acute ECGs large Q waves were more frequent in men (52%) than in women (36%), but ST segment depression of 1 mm or more (MC 4.1) was predominant in women in both the acute and 1-year ECGs. This ECG sign was related to the advanced age of the patients. There was no significant sex difference in the regression of the Q-QS signs, but the disappearance of ST and T wave changes occurred more extensively in men. The ECG returned to normal in 12% of men with a first MI but only infrequently in women and men with recurrent MI.

The 125I-labelled fibrinogen uptake test in elective hip surgery.

The value of the 125I-labelled fibrinogen uptake test as a screening method for deep vein thrombosis was estimated in 49 patients (97 extremities) undergoing elective hip operations. The legs were monitored preoperatively, on the 1st, 2nd and 4th postoperative days. Contrast venography, as a reference method, was performed on the 5th postoperative day. The sensitivity was 73%, specificity 85%, positive predictive value 63%, negative predictive value 86% and correlation coefficient 55%. 78% of fibrinogen uptakes appeared within the first 24 hours, and 6% on the 4th postoperative day. Only 1 of 3 patients with a positive fibrinogen uptake test in the femoral region had roentgenologic evidence of deep vein thrombosis. According to these results the isotope-labelled fibrinogen uptake test can also be utilized as a screening method in elective hip surgery.

Screening for postoperative pulmonary embolism on the basis of clinical symptomatology, routine electrocardiography and plain chest radiography.

The incidence of pulmonary embolism (PE) and the usefulness of various screening methods for its detection were studied in 108 patients undergoing elective hip surgery. Twenty patients had PE as shown by perfusion-ventilation lung scintigraphy. Six of them had symptoms of embolism. Clinical symptoms of PE, highly suggestive electrocardiographic (ECG) signs and signs in chest radiographs showed high specificity but low sensitivity with regard to PE. If the non-specific ECG signs and the symptoms and signs of deep vein thrombosis in the calves had also been taken into account, it would have been possible to identify 95% of the patients with PE. The use of all these screening tests revealed a suspicion of PE in two thirds of the patients. The simplest way to screen for postoperative PE seems to be to use a combination of the symptoms and signs of both PE and deep vein thrombosis, and to identify any tachycardia. This method gave a sensitivity of 85%.

Postoperative thromboembolism and risk factors in elective hip surgery.

The incidence of pulmonary embolism determined by perfusion - ventilation lung scintigraphy was 19% in 108 consecutive patients undergoing elective hip operations. Twelve patients had clinical symptoms. The sensitivity of clinical symptoms was 30 and the specificity 93%. Warfarin was used as prophylactic anticoagulant. The incidence of deep vein thrombosis examined by contrast venography was 43%. Only one patient developed femoral vein thrombosis propagating from the calf region. From the clinical risk factors, overweight had a statistically significant relationship to thromboembolism (p = 0.005). Age over 60 years was positively associated but the difference was not significant. When operation time exceeded 150 min the risk increased significantly (p less than 0.01). A large volume of blood loss at operation showed an increased but statistically insignificant trend towards thromboembolism. There were no fatal emboli. Although prophylactic warfarin treatment is not able to prevent the development of thromboembolism, it probably reduces the incidence of fatal pulmonary emboli. Of clinical and operative risk factors overweight and increasing operation time seem to have the strongest relationship to thromboembolism.

In-hospital death from ischaemic heart disease.

The clinical course and the clinical and pathological factors were studied in a series of 112 in-hospital patients who died of acute myocardial infarction. A necropsy was performed in 101 cases. 44% of the victims were concluded to have been past the possibility of recovery at the time of admission, as the treatment of early ventricular fibrillation or asystole did not lead to a satisfactory result, or as a refractory heart failure or shock dominated from admission to death. Resuscitations due to early ventricular fibrillation were performed in the emergency department mainly on patients living near the hospital. On the other hand, an early heart failure was more frequent among those whose transit distance was over 15 km. Prior use of beta-receptor blockers seemed to protect against early complications. The cardiac functions of the remaining patients were normal or could be normalized at the beginning of the hospitalization. The great majority of them were later lost as a result of extensive damage of the myocardium leading to a refractory heart failure and some due to a rupture caused by infarction (8%) or due to embolic complications (10%). Only 11 patients (10%) succumbed to late ventricular fibrillation without heart failure, rupture, or embolism. The cardiac disease revealed by the necropsy was more severe in patients with a refractory heart failure than in those who died of late ventricular fibrillation or rupture without a preceding heart failure. Various arrhythmias were frequent during the hospitalization. 74% of the dysrhythmias were preceded or followed by symptoms of a heart failure.

Early pronounced ST segment depression with marked J point decline heralding acute lethal clinical myocardial infarction: Necropsy-electrocardiographic correlative study.

Marked ST segment depression (greater than or equal to 2 mm J point decline with horizontal or downsloping ST) was correlated with necropsy findings in 105 cases. Acute myocardial infarction (AMI) was most frequently (70%) responsible for development of the abnormal ST pattern, thereby indicating the diagnosis and severe prognosis of the AMI. In 23% of patients the ST segment depression pattern was associated with chronic heart disease without AMI; all were severely ill with 92% receiving digitalis. Sudden worsening of the basic heart disease or circulatory shock were frequently found to coincide with the abnormal ST pattern; necropsy revealed extensive old MI or myocardial fibrosis in these patients. Marked ST segment depression was also found in five patients without underlying heart disease at autopsy; an acute cerebral accident or circulatory shock was considered to have produced the abnormal ST segment pattern.

Coronary atherosclerosis in middle-aged and elderly Finnish men. Pathological study of coronary arteries in violent and sudden coronary deaths.

The occurrence of coronary atherosclerosis was studied in 271 Finnish men aged 40 years or more, of whom 143 had met a violent death and 128 had died suddenly of coronary heart disease (CHD). A coronary stenosis was found in half of the men who had met a violent death and were over 50 years old. The occurrence of the stenosis was closely related to the extent of the raised atherosclerotic lesions (RL) and to the degree of the plaque calcification. In 60% of the sudden deaths (SD) the extent of RL did not differ from that in violent deaths. The stenosis patterns in these SD were similar to those in living CHD patients. The remaining SD had an extreme stage of coronary artery involvement, i.e. extensive plaques with severe obstructive changes. The men in this study series of violent deaths born in various parts of the country did not differ with regard to the extent of RL. Within the upper half of the RL area range, men born in the east were consistently shown to have a stenosis, while the occurrence in men from the western counties was more random. Severe stages of coronary artery involvement tended to be more frequent in SD patients born in the east than in those born in the west. It was concluded that there are probably two background factors concerning the difference in CHD mortality between men in western and eastern Finland: 1) the tendency to form a stenosis by the advancement of RL extent is stronger, and 2) the progressive development of coronary artery disease in CHD patients is more frequent in the east than the west.

Changes in the QRS complex and ST segment in transmural and subendocardial myocardial infarctions. A clinicopathologic study.

The QRS complex and ST segment in the ECGs of 80 patients who died of an acute myocardial infarction (MI) were studied in relation to the extent of the MI (subendocardial vs. transmural). Changes in the QRS complex developed in nine out of the 15 cases with an acute subendocardial MI. Five of these cases fulfilled the conventional QRS criteria for a myocardial infarction. A definite ST segment depression (a J point depression of 2 mm. or more in at least one lead, and a horizontal or downward sloping ST segment with a minimum duration of 0.08 sec.) occurred most frequently in connection with a circumferential subendocardial MI (88 per cent), but it was also found in a regional subendocardial (43 per cent) and transmural MI (43 per cent). In 17 per cent of the cases with a transmural MI, this was the only ECG abnormality. It is concluded that cases with a subendocardial MI cannot always be distinguished from transmural MI on the basis of the presence or absence of the QRS changes, and that an ST segment depression, as defined in this study, can give additional information in the evaluation of an acute phase of an MI.

Sudden coronary death and coronary artery disease. A clinicopathologic appraisal.

Clinicopathologic and epidemiological aspects of coronary artery disease (CAD) in relation to sudden death (SD) were studied in three postmortem series, two of sudden cardiac death and one of male violent death. There appears to be a critical level of severity of CAD which determines the risk of SD. The more severe the CAD within this range, the higher is the risk. Every annual cohort of SDs includes many patients with extremely severe, or 'burned-out', disease. CAD alone, however, is not a selective factor for sudden or not-sudden death. Epidemiological analysis (a) determines the age and frequency of persons reaching the critical risk level of CAD severity in the population (atherogenic factors); (b) influences the selection of the SD victims from the critical population (precipitating factors), and (c) determines the individual variation of CAD severity with which coronary heart disease and SD manifest themselves (sensitising and protecting factors).