Impact of Prosigna test on adjuvant treatment decision in lymph node-negative early breast cancer-a prospective national multicentre study (EMIT-1).

BACKGROUND: EMIT-1 is a national, observational, single-arm trial designed to assess the value of the Prosigna, Prediction Analysis of Microarray using the 50 gene classifier (PAM50)/Risk of Recurrence (ROR), test as a routine diagnostic tool, examining its impact on adjuvant treatment decisions, clinical outcomes, side-effects and cost-effectiveness. Here we present the impact on treatment decisions. PATIENTS AND METHODS: Patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative pT1-pT2 lymph node-negative early breast cancer (EBC) were included. The Prosigna test and standard histopathology assessments were carried out. Clinicians' treatment decisions were recorded before (pre-Prosigna) and after (post-Prosigna) the Prosigna test results were disclosed. RESULTS: Of 2217 patients included, 2178 had conclusive Prosigna results. The pre-Prosigna treatment decisions were: no systemic treatment (NT) in 27% of patients, endocrine treatment alone (ET) in 38% and chemotherapy (CT) followed by ET (CT + ET) in 35%. Post-Prosigna treatment decisions were 25% NT, 51% ET and 24% CT + ET, respectively. Adjuvant treatment changed in 28% of patients, including 21% change in CT use. Among patients assigned to CT + ET pre-Prosigna, 45% were de-escalated to ET post-Prosigna. Of patients assigned to ET, 12% were escalated to CT + ET and 8% were de-escalated to NT; of those assigned to NT, 18% were escalated to ET/CT + ET. CT was more frequently recommended for patients aged ≤50 years. In the subgroup with pT1c-pT2 G2 and intermediate Ki67 (0.5-1.5× local laboratory median Ki67 score), the pre-Prosigna CT treatment decision varied widely across hospitals (3%-51%). Post-Prosigna, the variability of CT use was markedly reduced (8%-24%). The correlation between Ki67 and ROR score within this subgroup was poor (r = 0.25-0.39). The median ROR score increased by increasing histological grade, but the ROR score ranges were wide (for G1 0-79, G2 0-90, G3 16-94). CONCLUSION: The Prosigna test result changed adjuvant treatment decisions in all EBC clinical risk groups, markedly decreased the CT use for patients categorized as higher clinical risk pre-Prosigna and reduced treatment decision discrepancies between hospitals.

Work ability 8 years after breast cancer: exploring the role of social support in a nation-wide survey.

INTRODUCTION: As the 5-year survival rate after breast cancer in Norway is 92%, the population of breast cancer survivors (BCSs) is increasing. Knowledge of work ability in this population is scarce. In a population-based cohort of BCSs, we explored work ability 8 years after diagnosis and the association between work ability and social support, and cancer-related variables including late effects and lifestyle factors. METHODS: In 2019, all Norwegian women < 59 years when diagnosed with stage I-III breast cancer in 2011 or 2012, were identified by the Cancer Registry of Norway and invited to participate in a survey on work life experiences. Work ability was assessed using the Work Ability Index (scale 0-10). Factors associated with excellent work ability (score ≥ 9) were identified using univariate and multivariate logistic regression analyses, and adjusted for socioeconomic-, health- and cancer-related variables. RESULTS: Of the 1951 eligible BCSs, 1007 (52.8%) responded. After excluding survivors with relapse (n = 1), missing information on work ability score (n = 49), or work status (n = 31), the final sample comprised 926 BCSs within working age at survey (< 67 years). Mean age at survey was 56 years and 8 years (SD 0.7) had passed since diagnosis. Work ability had been reduced from 8.9 (SD 2.3) at diagnosis to 6.3 (SD 3.1). One in three BCSs reported poor work ability (WAS ≤ 5), and seven out of ten reported that their physical work ability had been reduced due to cancer. Social support from colleagues during cancer therapy was associated with excellent work ability, which was not observed for social support provided by supervisors or the general practitioner. Cognitive impairment and fatigue were inversely associated with work ability. None of the cancer-related variables, including treatment, were associated with work ability 8 years after diagnosis. CONCLUSION: In this population-based sample, one in three BCSs reported poor work ability 8 years after diagnosis. Collegial social support during cancer therapy appears to be a protective factor for sustained work ability, whilst survivors struggling with fatigue and cognitive impairments may represent a particularly vulnerable group for reduced work ability.

Increased somatic morbidity in the first year after leaving opioid maintenance treatment: results from a Norwegian cohort study.

BACKGROUND/AIMS: Some patients on opioid maintenance treatment (OMT) leave treatment temporarily or permanently. This study investigated whether patients interrupting their OMT differed from non-interrupters in sociodemographic and drug-use characteristics and examined acute/sub-acute somatic morbidity among the interrupters, prior to, during, and after OMT. METHODS: Cohort design. OBSERVATION PERIOD: 5 years prior to, up to first 5 years during, and up to 5 years after interruption of OMT. PARTICIPANTS: The sample (n = 200) comprised 51 OMT interrupters and 149 non-interrupters. Data on patient characteristics were obtained from interviews and OMT register information. Data on somatic morbidity were gathered from hospital records. MEASUREMENTS: Key patient characteristics among OMT interrupters and non-interrupters. Incidence rates of acute and sub-acute somatic disease incidents leading to hospital treatment (drug-related/non-drug-related/injuries) prior to/during/after OMT. RESULTS: Interrupters and non-interrupters did not differ in sociodemographic characteristics, while longer duration of amphetamine and benzodiazepine dependence predicted OMT interruption. Interrupters scored significantly higher on drug-taking and overdose during OMT but still had a significant 41% reduction in drug-related treatment, episodes. After interruption of treatment, such episodes increased markedly and were 3.6 times more frequent during the first post-OMT year compared to the pre-OMT period (p < 0.001). This increase was highest during the first months after OMT interruption. 2-5 years after interruption there was no significant increase. CONCLUSIONS: Increased somatic morbidity was found among OMT interrupters during the first year after OMT, and especially during the immediate post-treatment period.

Mean HbA1c over 18 years predicts carotid intima media thickness in women with type 1 diabetes.

AIMS/HYPOTHESIS: Intima media thickness (IMT) of the common carotid artery (CCA) is a validated surrogate marker of early atherosclerosis. The aim of our study was to assess the association between IMT in CCA and long-term mean HbA1c in type 1 diabetes. We also elucidated the association between carotid IMT and preclinical coronary atherosclerosis. METHODS: In 39 individuals with type 1 diabetes, HbA1c was measured prospectively over 18 years. The IMT examinations were performed with high-resolution ultrasound. The association between carotid IMT and preclinical coronary atherosclerosis (assessed by intravascular ultrasound [IVUS]) was tested in 29 of the patients. RESULTS: Mean HbA1c over 18 years was 8.2% (range: 6.6-11.3%). Mean age at follow-up after 18 years was 43 years and mean duration of diabetes was 30 years. IMT was significantly higher in diabetic patients than in an age- and sex-matched reference population. The IMT values were at the same level as for controls who were 20 years older. In women, HbA1c was significantly associated with mean average CCA IMT (r2=0.77, p<0.0001 when adjusted for age), whereas there was no significant association for men. Among women, a significant association was also found between carotid IMT and the percentage of coronary vessel area stenosis (r=0.65, p=0.03). CONCLUSIONS/INTERPRETATION: The present findings suggest an important role of long-term hyperglycaemia in the development of atherosclerosis, especially in women with type 1 diabetes. Type 1 diabetes patients have earlier development of, and more advanced, atherosclerosis compared with an age- and sex-matched reference population. In women, carotid IMT reflects preclinical coronary atherosclerosis.

Blood platelet count and reactivity are associated with restenosis 6 months after coronary angioplasty.

OBJECTIVES: Restenosis occurs in 40-50% of patients treated with percutaneous transluminal coronary angioplasty (PTCA). Some data indicate that platelet derived growth factor (PDGF) plays a pathogenetic role. The aims of the present study were to measure the plasma levels of PDGF across the coronary circulation during PTCA and relate them to the development of restenosis. DESIGN AND RESULTS: Blood samples from the aortic root and coronary sinus were drawn simultaneously before, and after completed PTCA in 26 patients. Plasma levels of PDGF and beta-thromboglobulin (BTG), as well as platelet counts were measured. Restenosis was evaluated by quantitative coronary angiography after 6 months. Significant increases both in PDGF and BTG were encountered in the aortic root after PTCA in patients who developed restenosis as compared to patients without restenosis. Patients who developed restenosis also had significantly higher platelet counts compared to those without. CONCLUSION: Increases in plasma PDGF and BTG in the aortic root after PTCA seem to be markers for restenosis 6 months after PTCA. This finding may strengthen the hypothesis that platelets contribute to the process of restenosis.

Long-term prognosis after out-of-hospital cardiac arrest and primary percutaneous coronary intervention.

AIMS: To study the long-term survival after out-of-hospital cardiac arrest and successful cardiopulmonary resuscitation (CPR) in patients with acute ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI). MATERIAL AND METHODS: In-hospital and 2-year survival of 40 patients treated with primary PCI after out-of-hospital cardiac arrest and STEMI was compared with that of a reference group of 325 STEMI patients, without cardiac arrest, also treated with primary PCI in the same period. RESULTS: In the group with out-of-hospital cardiac arrest, both in-hospital and 2-year mortality was 27.5%. In the reference group, in-hospital and 2-year mortality was 4.9 and 7.1%, respectively. After discharge from hospital there was no significant difference in mortality between the groups. CONCLUSION: Long-term prognosis is good in selected patients after successful out-of-hospital CPR and STEMI treated with primary PCI.

Safety of heparin reversal with protamin and immediate sheath removal after coronary angioplasty.

PURPOSE: To study the safety of giving protamin after coronary angioplasty to reverse heparin for immediate removal of the femoral sheath. MATERIAL AND METHODS: After successful angioplasty, 100 patients were randomized to receive protamin and immediate sheath removal or to the control group with sheath removal after 3 h. Patients were followed for 30 days so that groin complications and coronary events could be compared. After 6 months, target vessel revascularization and death were recorded. RESULTS: The time to mobilization was significantly shorter in the protamin group compared to the control group; 6 versus 19 h. The protamin patients were more satisfied than the control patients, in particular during bed rest after compression. Puncture site complications were one (2%) and two (4%) pseudoaneurysms in the protamin group and the control group, respectively. Early angina and restenosis/reocclusion before 30 days were seen in 4 patients in the protamin group and in 1 in the control group. Adverse incidents between 30 days and 6 months were the same for both groups. CONCLUSION: Protamin reversal improved patient comfort and reduced immobilization time. The cardiac safety concern observed requires the antiplatelet agent clopidogrel to be given before the procedure.

Elective placement of covered stents in native coronary arteries.

PURPOSE: To study the feasibility of placing a polytetrafluoroethylene (PTFE)-covered stent graft into native coronary arteries and assess the complications and the restenosis rate. MATERIAL AND METHODS: Fifty consecutive patients with stable angina pectoris were included and the stent graft was placed into native coronary arteries. Clinical and angiographic follow-up were performed after 6 months. RESULTS: The stent grafts were successfully placed in all patients. The mean reference diameter was 3.3 +/- 0.6 mm. During follow-up the stent grafts occluded in patients after 1, 2 and 2.5 months and one more was occluded at 6 months. Three patients experienced myocardial infarction, 2 Q wave and one non-Q wave. After 6 months 42 (84%) patients had angina NYHA class 0 or 1. Target vessel revascularization was done in 11 cases for restenosis in the graft (n = 4), outside the graft (n = 3) and both (n = 4), giving a restenosis rate of 24%. The total major adverse coronary events at 6 months was 24%. CONCLUSION: The stent graft was deployed with a high success rate. The restenosis rate was not higher than expected for bare stents. However, this study showed that subacute occlusion may occur more frequently and we therefore recommend that ticlopidine or clopidogrel treatment should be prolonged to at least 3 months.

Posterior facet talocalcaneal coalition.

Posterior facet talocalcaneal coalition is one of the rarest forms of talocalcaneal coalition. When a posterior facet coalition occurs, it typically involves a majority of the posterior facet articular surface. The authors present a rare form of posterior facet talocalcaneal coalition in an 11- year-old girl. A brief review of the literature is provided, along with the case history, including radiographic findings and intraoperative and postoperative illustrations.

Variation in clinical preventive services.

CONTEXT: Preventive services are not delivered at optimal rates in primary care settings, and the literature suggests that a systems approach is key to improvement. Studying variation among clinics could help us to understand the extent of system use in practice. PRACTICE PATTERN EXAMINED: The proportion of patients who are up-to-date for preventive services in 44 primary care practices in the Midwest. PREVENTIVE SERVICES EXAMINED: Papanicolaou (Pap) smear, cholesterol testing, mammography, clinical breast examination, blood pressure measurement, influenza and pneumococcal vaccinations, and advice on tobacco use. DATA SOURCE: 6830 patients surveyed after their clinic visit (response rate, 85%). RESULTS: The proportion of patients up-to-date for preventive services varied widely among clinics. For example, up-to-date rates for Pap smear testing ranged from 70% to 93% and 45% to 88% for cholesterol screening. There was little correlation between a clinic's performance on one preventive service (relative to the other 43 clinics) and its performance on others. When correlations between pairs of up-to-date rates within clinics were examined, only 4 of 28 service pairs were positive and statistically significant and only 1 had a correlation coefficient that exceeded 0.5 (for mammography and clinical breast examination). CONCLUSION: There is wide variation in the rates at which various preventive services are performed, both between and within clinics. This variation, which is probably due to a lack of organized prevention systems that cover multiple services, provides a clear target for improvement efforts.

Predictors of restenosis after coronary angioplasty. A study on demographic and metabolic variables.

OBJECTIVE: The major concern about percutaneous transluminal coronary angioplasty (PTCA) is the high incidence of restenosis. METHODS: Demographic, clinical and biochemical data were recorded 2 weeks prior to PTCA in 388 patients fulfilling the criteria for initial stenosis, successful PTCA, and angiographic follow-up after 6 months. Restenosis was evaluated by quantitative coronary angiography. RESULTS: Variables predictive of restenosis in univariate analysis were diabetes mellitus, male gender, and the levels of high density lipoprotein (HDL) cholesterol, apolipoprotein A1 (Apo A1) and thio-barbituric acid-reactive substances (TBARS). In trend analysis through quartiles TBARS and fasting glucose levels were significantly associated with restenosis (p = 0.016 and 0.044, respectively), whereas the negative predictivity of Apo A1 and HDL-cholesterol were of borderline significance. In multivariate analysis male gender and diabetes mellitus showed predictivity of significance, and a negative predictivity was also apparent for HDL-cholesterol. CONCLUSION: We conclude that diabetes mellitus, male gender, and low HDL-cholesterol are predictors of restenosis 6 months after PTCA. In addition, TBARS may be a marker for the development of restenosis after PTCA.

Self-efficacy and health status in rheumatoid arthritis: a two-year longitudinal observational study.

OBJECTIVE: To investigate the relationship between baseline level of self-efficacy for pain and other symptoms and changes in measures for similar dimensions of health status over a period of 2 yr in patients with rheumatoid arthritis (RA). METHODS: Data collected from patients with RA enrolled in a county-based disease register in Oslo, Norway were analysed: 815 patients were examined by mail questionnaire in 1994 and again in 1996. Relationships of the baseline level of self-efficacy and demographic variables with 2-yr changes in health status measures were examined by bivariate and multiple regression analysis. The following health status measures were included: pain and fatigue on a visual analogue scale; the patient's global assessment of disease activity; the symptom and affect scales of the Arthritis Impact Measurement Scales (AIMS2); and the bodily pain, mental health, general health and vitality scales of the Short Form-36 (SF-36). RESULTS: For all health status measures, there was a significant correlation between the change over a 2-yr span and baseline self-efficacy, even after adjustment for demographic variables and for the baseline level of the health status measure. Favourable changes were associated with high self-efficacy scores. CONCLUSIONS: In patients with RA, the baseline levels of self-efficacy for pain and other symptoms seem to influence 2-yr changes in health status measures regarding these aspects.

Involvement and satisfaction: a Norwegian study of health care among 1,024 patients with rheumatoid arthritis and 1,509 patients with chronic noninflammatory musculoskeletal pain.

OBJECTIVE: To investigate involvement in and satisfaction with health care among patients with rheumatoid arthritis (RA) and persons with chronic noninflammatory musculoskeletal pain, to identify target areas for improvement. METHODS: Data were collected from postal surveys carried out in 1994 in Oslo, Norway, with 1,542 patients with RA and 10,000 randomly selected adults. Patients with RA and persons with noninflammatory musculoskeletal pain were asked 3 questions about their involvement with treatment and 1 question about their satisfaction with health care. Levels of involvement and of satisfaction were related to demographic measures, health status measures, use of health services, and, for patients with RA, self-efficacy. RESULTS: Of the respondents with RA (n = 1,024), 40% scored low on at least 1 question on involvement and 11% reported global dissatisfaction. Being young, well educated, physically disabled, in good mental health, and self-efficient and having visited a rheumatologist in the last 12 months were associated with a high level of involvement; being female and having a low pain level, good mental health, and high self-efficacy were associated with satisfaction with health care. Of persons with noninflammatory musculoskeletal pain of more than 5 years duration (n = 1,509), 57% scored low on at least 1 question on involvement and 27% reported global dissatisfaction. Being well educated, having visited a general practitioner in the last 12 months, and having ever visited a rheumatologist were associated with a high level of involvement. Being older and having a low pain level and good mental health were associated with satisfaction. A low score on involvement was a strong independent predictor of global dissatisfaction in both groups. CONCLUSION: High education level and health service provided by rheumatologists were consistently associated with a high level of involvement. Good mental health and high involvement were associated with satisfaction with the care received. Efforts to achieve a higher level of patient involvement should especially be directed toward patients with low education, emotional distress, and a chronic physical disorder.

[Angiographic results of primary angioplasty in acute myocardial infarction]. / Angiografiske resultater av primaer angioplastikk ved akutt hjerteinfarkt.

BACKGROUND: Percutaneous angioplasty is an alternative to thrombolysis to reestablish coronary blood flow in patients with transmural myocardial infarction. At present, this treatment option is not widely accepted in Norway. MATERIAL AND METHODS: From 1996 to 1998, one hundred consecutive patients were treated with angioplasty for acute transmural infarction. The angiography showed one-vessel disease in 55%, two-vessel in 25%, and multivessel in 20%. The infarct related artery was the LAD in 44%, the CX in 14%, the RCA in 41%, and bypass graft in one. 92% had TIMI 0 or 1 flow. Stent was placed in 73%, GPIIb/IIIa was used in 11% and temporary pacemaker placed in 5%. RESULTS: Successful angioplasty was performed in 95%, 3% was not done, and 2% failed. Peripheral stenoses were treated in 15% and stenoses in other arteries in 10%. Complications and events within 24 hours related to the angioplasty were seen in 9%. CONCLUSION: Primary angioplasty for acute myocardial infarction can be done with high primary success, good short-term results and few complications.

[Hundred patients with acute myocardial infarction treated with primary angioplasty]. / Ett hundre pasienter behandlet med primaer angioplastikk ved akutt hjerteinfarkt.

BACKGROUND: Much attention has lately been focused on primary angioplasty in the treatment of acute myocardial infarction. This report describe our results in 100 patients. MATERIAL AND METHODS: 100 consecutive patients with acute ST elevation myocardial infarction and a history of less than six hours were treated with primary angioplasty. The mean time from start of symptoms until establishment of reperfusion of the infarct related artery was 224 minutes; "the door-to-balloon" time was 69 minutes. RESULTS: Angioplasty was successful in 95% of all patients. Mean ejection fraction measured before discharge in 71 patients was 56%. Hospital and 30-days' mortality was 1%. New revascularization was needed in 6%. Average observation period in the coronary care unit was 1.8 days; no patient needed treatment for ventricular arrhythmias after angioplasty. The first 24 hours 24% had symptomatic congestive heart failure, reduced to 11% at hospital discharge on day 6. Acute rehospitalization within the first 30 days was necessary in 7%, but only in 2% for chest pain. INTERPRETATION: Our results are comparable to those of other high volume centres and show well preserved ventricular function and low hospital and 30-days' morbidity and mortality.

Attitudes of Olmsted County, Minnesota, residents about tobacco smoke in restaurants and bars.

OBJECTIVE: To determine the attitudes of Olmsted County, Minnesota, adults about environmental tobacco smoke in restaurants, bars, and nightclubs. SUBJECTS AND METHODS: In this population survey,2014 adults were contacted by random digit dial methods between February 28 and May 5, 2000, and asked to participate in a telephone survey; 1224 (61%) consented. RESULTS: For the 57% (95% confidence interval [CI], 54%-60%) of the study population that reported exposure to environmental tobacco smoke, the most frequently reported sites of exposure were restaurants (44% [95% CI, 41%-48%]), work (21% [95% CI, 18%-24%]), and bars (19% [95% CI, 16%-22%]). Seventy-two percent (95% CI, 69%-74%) of respondents said that they would select a smoke-free restaurant over one where smoking is permitted, and 70% (95% CI, 67%-72%) said that they would select a smoke-free bar over one where smoking is permitted. The majority of respondents said that they would not dine out or visit bars or nightclubs more often or less often if all restaurants, bars, and nightclubs were smoke-free. CONCLUSIONS: Olmsted County residents prefer smoke-free restaurants, bars, and nightclubs.