[Insurance claims after vascular surgery]. / Erfarenheter av undvikbara skador vid kärlkirurgi.

Insurance claims after vascular surgery have been analyzed during two three-year periods. Ca 0.6 % of arterial operations and 0.3 % of venous operations have been claimed, 30 % and 40 % respectively having been economically compensated as they were judged avoidable. The increase in endovascular treatments has not influenced the pattern of claims.

The Consequences of Negligence Claims in Arterial Surgery - An Analysis of Two Periods with an Increasing Use of Endovascular Treatment.

OBJECTIVES: Patient treatment within the Swedish medical service system can claim negligence injuries to the malpractice insurance review board and request financial compensation. The aim of this paper was to analyse the consequences of a negligence claim after arterial surgery between two periods with increasing use of endovascular treatment. METHODS: This was a retrospective cohort study of the arterial surgery negligence claims from two three year periods 2005-2007 (Period A) and 2012-2014 (Period B) from the County Council's Mutual Insurance Company. The analysis was restricted to aortic, carotid, and lower limb arterial diseases. The magnitude of surgery for vascular diseases was obtained from the Swedish vascular register (Swedvasc). RESULTS: The number of patients undergoing arterial procedures increased from 16 628 to 20 709 (p = .01). There was an increase of 54% in the number of negligence claims between the periods. In Period A, the number of compensated claims was 22 out of 83 (29%) and in Period B 60 out of 151 (41%) (p = .06). Patients treated for aortic disorders and peripheral arterial surgery received compensation with increasing frequency whereas carotid diseases decreased. Claimants treated for aortic disorders were compensated in four out of 23 (17%) and 21 out of 54 (39%) in the two periods (p = .07), and after lower limb arterial surgery in six out of 34 (18%) and in 24 out of 71 (34%) (p = .09). After carotid surgery the corresponding figures were 12 out of 26 (46%) and 14 out of 25 (46%) (p = .48). The increasing use of endovascular procedures (but not in carotid artery surgery) did not seem to influence the pattern of negligence claims. CONCLUSIONS: Between the two three year periods there has been an increase in negligence claims but not in compensated ones. The increased use of endovascular procedures has not influenced the pattern of compensated negligence claims.

Staging and therapy for patients with hepatocellular cancer in a defined population from 2000 to 2011 - active palliative treatment improved overall survival.

BACKGROUND: Sweden's western region has successively introduced the use of validated non-invasive diagnostic algorithms and treatment allocation for hepatocellular cancer (HCC). The aim was to analyse whether between 2000 and 2011 these changes in strategy had an impact on survival. METHODS: Data concerning diagnosis, survival and treatment for 687 individuals with HCC were retrieved from the regional cancer centre's register and hospital charts. The 12-year period was divided into three four-year cohorts (A-B-C). RESULTS: There was an increase in the crude incidence rate of HCC from 2.7 to 4.2 per 100 000 inhabitants (p < 0.0001) over the period studied. Imaging was increasingly used for diagnosis over the three time periods (1.4%, 7.9% and 29%; p < 0.0001). Alcohol abuse was the most common aetiology for underlying liver disease (42%). The median survival time for all HCC patients improved over time - period A: 3.8 months, period B: 5.1 months and period C: 7.0 months (p = 0.0007). The 209 patients without any underlying liver disease had a worse survival than the 377 with a reported underlying liver disease (p = 0.0001). Active palliative treatment (APT) increased from 17% to 35% during period C (p < 0.0001). For these patients, median survival increased from 8.8 months to 14.2 months. Best supportive care was used less over time. DISCUSSION: Overall survival improved when more patients had APT, mainly trans arterial chemoembolisation (TACE).

Does diagnostic delay of colorectal cancer result in malpractice claims? A retrospective analysis of the Swedish board of malpractice from 1995-2008.

AIM: Delay in the diagnosis of colorectal cancer (CRC) may have important clinical and medico-legal implications. This study identifies the claims made on the basis of delay in the diagnosis of CRC to the Swedish insurance agency (whose English name is The County Council´s Mutual Insurance Company) and the impact and consequences of the delay on prognosis, treatment and survival for patients who reported the claims. The Company handles claims of medical malpractice where claimants seek compensation for alleged suffering and/or negative clinical impacts of diagnostic delays. MATERIAL AND METHODS: Between January 1, 1995 and December 31, 2008, a total of 80 patients filed claims for negative effects resulting from delays in the diagnosis of CRC. Review of the claims led to identification of delay for 62 patients. The clinical symptoms that were overlooked and other causes of delay that had any relation to therapy, prognosis and economic compensation were evaluated. RESULTS: The median delay in the diagnosis of CRC was six months. This delay was considered to have had an impact on the therapy in 20 % of the cases. The prognosis was postulated to have been adversely affected for 15 % of the patients. The delay was mainly caused by incomplete consideration of the symptoms hematoschisis or anaemia, changed bowel routine, or incomplete clinical or radiological examination and by misinterpretations of the results. No impact of duration of delay on survival was identified. The importance of identifying concomitant metastatic disease at diagnosis was overwhelming. Economic compensation was given in 79 % of the cases. CONCLUSION: This study found that claims for compensation for delay in diagnosis of CRC are rare. The delay in the diagnosis of the primary tumour was considered to have had an impact on the magnitude of therapeutic measures for a fifth of the patients who filed claims. Economic compensation for the patients´ injuries was given in almost 80 % of the cases.

Diagnostic delay of breast cancer - an analysis of claims to Swedish Board of Malpractice (LÖF).

AIM: Delay in the diagnosis of breast cancer may have important clinical and medico-legal implications. This study examined the decisions made by reviewers at the Swedish agency (LÖF) that handles claims of medical malpractice where claimants seek compensation for alleged suffering and/or negative clinical impacts of diagnostic delays. MATERIAL AND METHODS: In 1995-2006 a total of 134 women filed claims for negative effects resulting from delays in the diagnosis of breast cancer. Review of the claims led to approval of delay in the primary diagnosis for 62 women and of recurrence for 28 women. The clinical symptoms that were overlooked and other causes of delay that had any relation to therapy, prognosis and economic compensation were identified. The verdicts reached were analysed. RESULTS: The median delay in the diagnosis of the primary disease was 11 months and for recurrent disease 3.5 months. Delay in diagnosis of the primary disease was considered to have an impact on the therapy in 23%. The prognosis was postulated to have been adversely affected 11% of the patients for whom the delay was longer than 12 months. Delay in diagnosing the recurrence was contributing to delay in starting therapy and to unnecessary suffering in 32%. The delay in diagnosis was mainly caused by incomplete clinical or radiological examination and by misinterpretations of the examination results. Economic compensation was given in 90%. There was a warning or admonition to the responsible doctor in a third of the cases referred to the judgement court. CONCLUSION: This study demonstrates that claims for compensation for delay in diagnosis of breast cancer in Sweden occur in about 1/1000 new patient. The delay in the diagnosis of the primary tumour was considered to have an impact on the magnitude of therapeutic measures in almost 25% of the women who filed claims. Economic compensation for the patients' injuries was given in ninety percent of the cases. In women for whom there was a delay in diagnosing the recurrence there was consequently a delay in starting the palliative therapy.

Effects of the mTOR inhibitor sirolimus in patients with hepatocellular and cholangiocellular cancer.

BACKGROUND: Hepatocellular cancer (HCC), as well as cholangiocellular cancer (CCC), has an extremely poor prognosis due to the extent of tumor at diagnosis and the underlying liver disease. Sirolimus is used in the transplantation setting as an immunosuppressive agent, but it also possesses antiproliferative and antiangiogenic properties. The objective of the study was to evaluate the effect of sirolimus on HCC and CCC. METHODS: In a prospective single-arm protocol, the tumor response to sirolimus as the primary endpoint was studied in 21 patients with advanced HCC and nine with CCC. Sirolimus was administered once daily by mouth, with the dose adjusted to a serum trough level between 4 and 15 mug/ml. Tumor response was evaluated by computed tomography (CT) or magnetic resonance imaging (MRI), according to the Response Evaluation Criteria in Solid Tumors (RECIST), every third month. Secondary measures were overall survival, time to tumor progression, tumor markers, and side effects. RESULTS: Of the patients with HCC, one had partial remission (PR) and fi ve patients had stable disease (SD) at 3 months. Of the patients with CCC, three had SD. The median survival for patients with HCC was 6.5 months (range, 0.2-36 months) and that for patients with CCC was 7 months (range, 2.6-35 months). CONCLUSION: Treatment of HCC and CCC with sirolimus can induce temporary PD or SD. This pilot study indicates that sirolimus might be a promising drug for this treatment, but further clinical studies elucidating the biological effects are advocated.

Isolated hepatic perfusion for liver metastases of malignant melanoma.

The objective was to analyze the outcome of three treatment strategies using isolated hyperthermic liver perfusion (IHP) with melphalan for liver metastases of malignant melanoma. It was designed as an exploratory study. The setting was a single-center study in a university hospital. The study was carried out on 27 patients. IHP was used with modifications during three different time periods (IHP I, IHP II and IHP III), in technique and temperature (amount of melphalan: 0.5, 1.0 and 2 mg/kg body weight in the perfusate; 41, 40 and 40 degrees C). Tumor response was estimated according to WHO criteria with computed tomography or MRI. Mortality and morbidity were secondary measures. Six of 11 patients in the IHP I cohort experienced a partial response (PR). In the IHP II cohort, two patients of 11 experienced a complete response and five a PR. In the IHP III cohort, five of five patients experienced a PR. Six postoperative deaths were reported (27%) (three in the IHP I and three in the IHP II series), secondary to liver insufficiency and multiorgan failure. Treatment of liver metastases of malignant melanoma with isolated hyperthermic melphalan perfusion has shown an impressive tumor response rate, which seems to be higher than the response rates reported for other systemic chemotherapy regimens. The maximum tolerated dose for melphalan in the perfusate was surpassed with a 2 mg/kg body weight. By modifying the technique and restricting the allowed tumor burden, the response rate remained high and the mortality was reduced.

Prediagnostic levels of carcinoembryonic antigen and CA 242 in colorectal cancer: a matched case-control study.

PURPOSE: Carcinoembryonic antigen is the classical tumor marker for colorectal cancer. The main clinical utility is in monitoring patients with colorectal cancer. Like carcinoembryonic antigen, the plasma level of CA 242 is elevated in patients with colorectal cancer. The purpose of this study was to investigate whether the plasma levels of carcinoembryonic antigen and/or CA 242 were elevated before clinical diagnosis of colorectal cancer. METHODS: The Northern Sweden Health and Disease Cohort was linked to the Swedish National and Regional Cancer registries, and 124 prospective cases with colorectal cancer were identified. Two referents for each case were randomly selected and matched for gender, age, date of sampling, and fasting time. Plasma from the included patients was analyzed for carcinoembryonic antigen and CA 242 using specific immunoassays. RESULTS: An elevated level of carcinoembryonic antigen before diagnosis was associated with an increased risk of developing manifest colorectal cancer (adjusted odds ratio, 7.9; 95 percent confidence interval, 2.1-29.1; P = 0.002). An elevated level of CA 242 was not significantly related to colorectal cancer risk. Elevated carcinoembryonic antigen levels were only seen in samples collected in the two-year time interval immediately before diagnosis. In this group, 30.4 percent of all plasma samples from cases were carcinoembryonic antigen-positive and 71.4 percent were future Dukes A or B cases. The specificity of the carcinoembryonic antigen test for identifying future colorectal cancer patients was 0.99 with a sensitivity of 0.12. For CA 242 the specificity was 0.92 and the sensitivity was 0.1. CONCLUSIONS: Elevated carcinoembryonic antigen levels strongly indicate occult colorectal cancer. Although the specificity of the carcinoembryonic antigen test in its present form is high, the sensitivity is disappointingly low, prohibiting the use of the carcinoembryonic antigen test for mass screening.

[Treatment of patients with liver metastases from colorectal cancer. More patients can benefit from the treatment!]. / Behandling av levermetastaser från kolorektal cancer. Fler kan ha nytta av behandling!

Liver resection for liver metastases goes with 30-40% five years survival. It is estimated that 10% of patients with liver metastases can be subjected to liver resection. In the Västra Götaland region, this number is not achieved. In the present material of 147 patients, the postoperative mortality was 2.7%. Five years survival was 33%. Preoperative chemotherapy and preoperative porta embolisation have extended the indication for liver resection. Reresection after recurrence limited to the liver should be considered in selected cases. Ablative measures are under development and should be evaluated in clinical trials. New chemotherapeutic drugs (oxaliplatin, irinotecan) with improved recurrence rate but with limited gain in survival might have an impact as adjuvant therapy. A surgeon with liver surgery competence should see patients with a presumably resectable cancer.

Unique antitumour effects of L-2,4 diaminobutyric acid on cultured hepatoma cells.

A single hepatoma cell line was grown in vitro and incubated with L-2,4 diaminobutyric acid (DAB), a non-metabolizable amino acid, under various conditions. The tumour cells were irreversibly damaged by incubation for 8 hours with 8 mmol/L of DAB. The tumour cell-destroying effect of DAB was dose- and time-dependent with no effect at a DAB concentration of 1.6 mmol/L. The presence of N-methyl alpha-aminoisobutyric acid (a specific substrate of amino acid transport system A) in the incubation medium abrogated the tumour cell destructive effect of DAB in a dose-dependent fashion. The presence of non-physiological amino acids in the incubation medium per se was not the cause of tumour cell destruction, since inclusion of alpha-amino-isobutyric acid and N-methyl alpha-aminoisobutyric acid in the incubation medium did not influence the viability of hepatoma cells. We conclude that the tumour cell destructive effect of DAB was the result of a huge and unlimited uptake of DAB energized by the Na(+)-gradient and that this uptake was not subjected to the law of saturation kinetics. This was combined with a tumour cell energy crisis in attempts to restore the Na(+)-gradient.

The Gothenburg Breast Screening Trial.

BACKGROUND: Although there is evidence for a reduction in breast carcinoma mortality with mammographic screening, some doubts have been expressed, and there is still uncertainty regarding the age specific effects. METHODS: The authors report on a randomized, controlled trial of mammographic screening for breast carcinoma that was conducted among 51,611 women (21,650 women who were invited to a screening [the study group] and 29,961 women in a control group) ages 39-59 years in Gothenburg, Sweden. Among women in the study group, the screening interval was 18 months. The screening phase of the trial took place in 1982-1991, and follow-up for breast carcinoma mortality continued until December 31, 1996. Mortality from breast carcinoma was analyzed using a Poisson regression model. Overall and age specific effects of invitation to mammography screening on breast carcinoma mortality were calculated. Three mortality effects were estimated: the effect on deaths from breast tumors diagnosed during the screening phase of the trial, as assessed by an independent Endpoint Committee (the EPC evaluation model); the effect on deaths from breast carcinoma diagnosed during the screening phase of the trial, as determined by data from the National Cancer Registry and the National Cause of Death Register (the SCB evaluation model); and the effect on deaths from all breast carcinomas diagnosed up to December 31, 1996, as determined by the National Cancer Registry and the National Cause of Death Register (the SCB follow-up model). RESULTS: A nonsignificant, 21% reduction in the rate of mortality from breast carcinoma with invitation to screening was observed using the EPC evaluation model (relative risk [RR], 0.79; 95% confidence interval [95% CI], 0.58-1.08; P = 0.14); and a borderline significant, 23% rate reduction was observed using the SCB follow-up model (RR, 0.77; 95% CI, 0.60-1.00; P = 0.05). Age specific analyses yielded greater mortality rate reductions for the groups of women ages 39-44 years, 45-49 years, and 55-59 years, but there was no mortality rate reduction in the group of women ages 50-54 years. The effects of invitation to mammographic screening on the incidence of lymph node-positive disease closely paralleled the effects of invitation on breast carcinoma mortality. The effect on breast carcinoma mortality was consistent with the effect on all-cause mortality, suggesting no bias in classification of cause of death. Breast carcinoma incidence in the study group was almost identical to the incidence in the control group after trial by screening had ended in the control group (RR, 0.98; 95% CI, 0.88-1.09; P = 0.7). CONCLUSIONS: The current results support the commonly observed 20-30% reduction in breast carcinoma mortality with invitation to screening. The impression that screening is less effective in women younger than 50 years may be an oversimplification. Age specific effects should be a target for further research.

[Guidelines for management of patients with pancreatic cancer]. / Riktlinjer för handläggning av patienter med pankreascancer.

The incidence of pancreatic cancer has fallen during the last ten years in Sweden. Early signs and symptoms of the disease are still undiscovered and when diagnosis is made the disease is incurable in most patients. Transabdominal ultrasonography is the first-line imaging test followed by spiral computed tomography (CT) and magnetic resonance imaging (MRI) if required for definite diagnosis. Spiral CT is also the imaging test of choice for assessment of resectability of the tumor. Surgical removal of the tumor is the only chance of cure. Markedly improved hospital mortality after pancreaticoduodenectomy is reported and an association between hospital volume and outcome of the operation has been established. Longterm survival after attempted curative resection continues to be dismal, however. Adjuvant treatment should not be given outside clinical studies. Palliative treatment has improved thanks to progress in the field of endoscopy, interventional radiology and in management of pain and nutrition. Palliative chemotherapy should only be given selectively outside clinical studies. Radiotherapy has no proven effects on survival. Special pancreatic cancer treatment teams with catchment areas of 2-4 million inhabitants are recommended by international authorities.

Chemotherapy in gastric cancer: a review and updated meta-analysis.

UNLABELLED: The five years survival rate for patients with gastric cancer is 15-25%. With the aim of improving survival, chemotherapy has been used in different adjuvant settings. Similarly, but with the aim of improving quality of life and prolonging life, chemotherapy has been used extensively in metastatic disease. In this review we have included studies of systemic and intraperitoneal chemotherapy given before, during or after operation and for advanced disease. A meta-analysis has been made on the 21 randomised studies that used adjuvant systemic chemotherapy postoperatively. A significant survival benefit for the patients treated postoperatively compared with controls was identified (odds ratio (OR) 0.84, 95% confidence interval (CI) 0.74 to 0.96). When western and Asian studies were analysed separately we found no survival benefit for the treated patients in the western groups (OR 0.96 (95 CI 0.83 to 1.12)). Flaws in the conduct of several trials made it difficult to draw firm conclusions, including the exclusion of a small but clinically meaningful survival benefit. Preoperative or neoadjuvant chemotherapy has shown effects in some patients, but no significant benefit was found in the few randomised studies. The few studies that reported intraperitoneal therapy showed no detectable survival benefit either. In patients with advanced disease, four small randomised studies found significantly longer survival in the treated patients. The survival benefit is in the range of 3-9 months, and there were also improvements of the quality of life. Several drug combinations have been tested, however, with no confirmed superiority for a particular regimen. CONCLUSIONS: Adjuvant chemotherapy cannot be recommended as a routine because of the lack of confirmed beneficial effects. Some patients with advanced disease will have a clinically important benefit from palliative chemotherapy, so this can be recommended for patients who are otherwise in good health.