BackgroundThe VascuQoL-6 (VQ-6) health-related quality of life questionnaire, a short version of the disease-specific VascuQoL-25, was developed for clinical practice and use in vascular registries. The study purpose was to evaluate the validity and reliability of VQ-6.MethodsVQ-6 was translated to Norwegian with linguistic validation and face value evaluation, and consecutive patients with intermittent claudication (IC) or critical limb ischemia (CLI) were included. All patients completed VQ-6 and Short Form-36 (SF-36), and were evaluated with ankle-brachial index (ABI) measurement pre- and post-exercise, a constant load treadmill test and clinical consultation at baseline and after 4 weeks. Correlation analysis, change statistics and receiver operator characteristics (ROC) curves were used to evaluate reliability, validity and responsiveness to change.ResultsOne hundred seventy-one patients with peripheral arterial disease (PAD) were included, 70 (41%) female. 147 (86%) of the patients suffered from IC. The reliability of VQ-6 was good, Cronbachs-α 0.82. The ability of VQ-6 to differentiate between IC and CLI was good, area under the curve (AUC) 0.754. There was good correlation between SF-36 physical domains and component scores and VQ-6 score (r = 0.55–0.62) and excellent responsiveness to change after treatment, standard response mean (SRM) 1.12. The clinical anchors of ABI at rest, treadmill walking performance and Fontaine class improvement were less responsive to change than VQ-6, SF-36 and the vascular surgeon’s evaluation.ConclusionsVQ-6 is reliable and valid, and can be used to evaluate PAD treatment in clinical practice and in vascular registries. Further research is necessary to determine the clinically important change over time.Trial registration ISRCTN14846962 (retrospectively registered).
Abstract. Os I, Hofstad AE, Brekke M, Abdelnoor M, Nesheim BI, Jacobsen AF, Birkeland K, Larsen A, Midtbù K, Westheim A (Ullevaal University Hospital and Aker University Hospital, Oslo, Norway). The EWA (Estrogen in Women with Atherosclerosis) Study: a randomized study of the use of hormone replacement therapy in women with angiographically verified coronary artery disease. Characteristics of the study population. Effects on lipids and lipoproteins. J Intern Med 2000; 247: 433±441.Objectives. To evaluate the effects of hormone replacement therapy (HRT) on lipids and lipoproteins in postmenopausal women with coronary artery disease. Setting. In this single-centre, controlled and randomized study taking place in a tertiary referral clinic, patients were examined at baseline, and after 3 and 12 months. All analyses were performed examinerblind. Subjects. Postmenopausal women (n = 118) with angiographically verified coronary artery disease were recruited consecutively from patients referred for investigational procedures due to coronary artery disease.Interventions. The women were randomized to HRT, i.e. transdermal application of continuous 17-b oestradiol with cyclic medroxyprogesterone actetate tablets every 3rd month for 14 days, or to a control group. Main outcomes. Effects on lipids and lipoproteins. Results. After 3 months of unopposed oestradiol, triglycerides decreased significantly compared to the control group (P = 0.006). Sequential administration of medroxyprogesterone caused a decrease in HDL cholesterol (P = 0.01), concomitantly with a decrease in ApoA1 lipoproteins (P = 0.007). No other changes in lipids or lipoproteins were observed. After 12 months of therapy, no significant differences were observed between the two groups in lipid or lipoprotein levels. Concomitant statin treatment did not alter the main findings. Conclusions. In postmenopausal women with established coronary artery disease in whom the majority is treated with statins, no additional effect of HRT on lipids or lipoproteins could be observed except for a transient decrease in triglycerides in the initial unopposed oestradiol phase. No deleterious effect could be observed during medroxyprogesterone administration except for a small transient decrease in HDL cholesterol and ApoA1 lipoproteins.
Objectives. To investigate possible associations between smoking habits and other coronary risk factors in postmenopausal women with known coronary heart disease (CHD). Setting. The study was conducted at a university clinic. Subjects. A total of 118 postmenopausal women with CHD verified with angiography, consecutively recruited. Interventions. Conventional treatment for CHD. The women were randomized to hormone replacement therapy (HRT) with transdermal 17-b oestradiol and medroxyprogesterone acetate, or to a control group. Results. Smokers were younger (P ¼ 0.005), had lower body mass index (P ¼ 0.04) and lipoprotein Lp(a) levels (P ¼ 0.02) compared with nonsmokers. Smokers had reduced b-cell function (homeostasis model assessment, P ¼ 0.006), whereas whole blood viscosity (WBV) was higher at all shear rates. WBV was not affected by HRT over a 12-month period. Oestrone levels were higher in smokers. Conclusions. Smoking adversely affects insulin secretion (b-cell function) and WBV in postmenopausal women with established CHD, which could be of importance as a mechanism for the increased risk of CHD in smokers. The importance of smoking as a risk factor, overrides the effect of Lp(a), which is lower in smokers compared with nonsmokers.
Objectives To analyze rates, odds ratios (OR), and characteristics of screen-detected and interval cancers after concordant and discordant initial interpretations and consensus in a population-based screening program. Methods Data were extracted from the Cancer Registry of Norway for 487,118 women who participated in BreastScreen Norway, 2006–2017, with 2 years of follow-up. All mammograms were independently interpreted by two radiologists, using a score from 1 (negative) to 5 (high suspicion of cancer). A score of 2+ by one of the two radiologists was defined as discordant and 2+ by both radiologists as concordant positive. Consensus was performed on all discordant and concordant positive, with decisions of recall for further assessment or dismiss. OR was estimated with logistic regression with 95% confidence interval (CI), and histopathological tumor characteristics were analyzed for screen-detected and interval cancer. Results Among screen-detected cancers, 23.0% (697/3024) had discordant scores, while 12.8% (117/911) of the interval cancers were dismissed at index screening. Adjusted OR was 2.4 (95% CI: 1.9–2.9) for interval cancer and 2.8 (95% CI: 2.5–3.2) for subsequent screen-detected cancer for women dismissed at consensus compared to women with concordant negative scores. We found 3.4% (4/117) of the interval cancers diagnosed after being dismissed to be DCIS, compared to 20.3% (12/59) of those with false-positive result after index screening. Conclusion Twenty-three percent of the screen-detected cancers was scored negative by one of the two radiologists. A higher odds of interval and subsequent screen-detected cancer was observed among women dismissed at consensus compared to concordant negative scores. Our findings indicate a benefit of personalized follow-up. Key Points • In this study of 487,118 women participating in a screening program using independent double reading with consensus, 23% screen-detected cancers were detected by only one of the two radiologists. • The adjusted odds ratio for interval cancer was 2.4 (95% confidence interval: 1.9, 2.9) for cases dismissed at consensus using concordant negative interpretations as the reference. • Interval cancers diagnosed after being dismissed at consensus or after concordant negative scores had clinically less favorable prognostic tumor characteristics compared to those diagnosed after false-positive results.
Short-term treatment with unopposed transdermal estradiol caused a decrease in insulin resistance, but long-term treatment after intermittent MPA was introduced had no effect on either insulin secretion or insulin resistance.
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