We developed and validated a prediction rule for the occurrence of early postoperative severe pain in surgical inpatients, using predictors that can be easily documented in a preoperative setting. A ...cohort of surgical inpatients (
n=1416) undergoing various procedures except cardiac surgery and intracranial neurosurgery in a University Hospital were studied. Preoperatively the following predictors were collected: age, gender, type of scheduled surgery, expected incision size, blood pressure, heart rate, Quetelet index, the presence and severity of preoperative pain, health-related quality of life the (SF-36), Spielberger's State–Trait Anxiety Inventory (STAI) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The outcome was the presence of severe postoperative pain (defined as Numeric Rating Scale ≥8) within the first hour postoperatively. Multivariate logistic regression in combination with bootstrapping techniques (as a method for internal validation) was used to derive a stable prediction model. Independent predictors of severe postoperative pain were younger age, female gender, level of preoperative pain, incision size and type of surgery. The area under the receiver operator characteristic (ROC) curve was 0.71 (95% CI: 0.68–0.74). Adding APAIS scores (measures of preoperative anxiety and need for information), but not STAI, provided a slightly better model (ROC area 0.73). The reliability of this extended model was good (Hosmer and Lemeshow test
p-value 0.78). We have demonstrated that severe postoperative pain early after awakening from general anesthesia can be predicted with a scoring rule, using a small set of variables that can be easily obtained from all patients at the preoperative visit. Before this internally validated preoperative prediction rule can be applied in clinical practice to support anticipatory pain management, external validation in other clinical settings is necessary.
Abstract Objective: To evaluate quantitatively articles that compared effects of second and third generation oral contraceptives on risk of venous thrombosis. Design: Meta-analysis. Studies: Cohort ...and case-control studies assessing risk of venous thromboembolism among women using oral contraceptives before October 1995. Main outcome measures: Pooled adjusted odds ratios calculated by a general variance based random effects method. When possible, two by two tables were extracted and combined by the Mantel-Haenszel method. Results: The overall adjusted odds ratio for third versus second generation oral contraceptives was 1.7 (95% confidence interval 1.4 to 2.0; seven studies). Similar risks were found when oral contraceptives containing desogestrel or gestodene were compared with those containing levonorgestrel. Among first time users, the odds ratio for third versus second generation preparations was 3.1 (2.0 to 4.6; four studies). The odds ratio was 2.5 (1.6 to 4.1; five studies) for short term users compared with 2.0 (1.4 to 2.7; five studies) for longer term users. The odds ratio was 1.3 (1.0 to 1.7) in studies funded by the pharmaceutical industry and 2.3 (1.7 to 3.2) in other studies. Differences in age and certainty of diagnosis of venous thrombosis did not affect the results. Conclusions: This meta-analysis supports the view that third generation oral contraceptives are associated with an increased risk of venous thrombosis compared with second generation oral contraceptives. The increase cannot be explained by several potential biases. What is already known on this topic Third generation oral contraceptives have been reported to increase the risk of venous thrombosis compared with second generation oral contraceptives The findings have been vigorously debated, with suggestions that the results can be explained by confounding or bias, or both. What this study adds Women taking third generation oral contraceptives have a 1.7-fold increased risk of venous thrombosis compared with those taking second generation oral contraceptives Risk is highest in first time users The biases were not large enough to account for the observed results
Abstract Background Heart failure (HF) is a serious complication and often the cause of death in adults with congenital heart disease (CHD). Therefore, our aims were to determine the frequency of ...HF-admissions, and to assess risk factors of first HF-admission and of mortality after first HF-admission in adults with CHD. Methods The Dutch CONCOR registry was linked to the Hospital Discharge Registry and National Mortality Registry to obtain data on HF-admissions and mortality. Risk factors for both HF-admission and mortality were assessed using Cox regression models. Results Of 10,808 adult patients (49% male), 274 (2.5%) were admitted for HF during a median follow-up period of 21 years. The incidence of first HF-admission was 1.2 per 1000 patient-years, but the incidence of HF itself will be higher. Main defect, multiple defects, and surgical interventions in childhood were identified as independent risk factors of HF-admission. Patients admitted for HF had a five-fold higher risk of mortality than patients not admitted (hazard ratio (HR) = 5.3; 95% confidence interval 4.2–6.9). One- and three-year mortality after first HF-admission were 24% and 35% respectively. Independent risk factors for three-year mortality after first HF-admission were male gender, pacemaker implantation, admission duration, non-cardiac medication use and high serum creatinine. Conclusions The incidence of HF-admission in adults with CHD is 1.2 per 1000 patient-years. Mortality risk is substantially increased after HF-admission, which emphasises the importance to identify patients at high risk of HF-admission. These patients might benefit from closer follow-up and earlier medical interventions. The presented risk factors may facilitate surveillance.
Purpose
Breast cancer incidence and survival is high, which results in high prevalence of breast cancer survivors. The risk of (death from) cardiovascular disease (CVD) is higher in patients exposed ...to cardiotoxic treatments, in particular if they have pre-existing CVD risk factors. This study systematically summarized the risk of death from CVD following breast cancer.
Methods
Databases of Medline, Embase, and the Cochrane Library were systematically searched using the following terms and synonyms: breast cancer, cardiovascular disease, and cause of death. Articles reporting on both risk and risk factors of CVD mortality following breast cancer were eligible for inclusion. The methodological quality of each article was assessed using the Newcastle Ottawa quality assessment scale for cohort studies.
Results
Fourteen articles were included assessing the risk of CVD mortality among 1,217,910 women with breast cancer. The methodological quality was high for the majority of the studies. Studies were heterogeneous in design, study population, length of follow-up, CVD outcomes, and risk factors. 1.6–10.4% of all women with breast cancer died of CVD. Women with breast cancer had a higher risk of CVD mortality than women from the general population. The risk of CVD mortality was higher among women with breast cancer with older age at diagnosis, left-sided tumor, diagnosis in an earlier calendar period, and black ethnic origin.
Conclusions
CVD is an important cause of death following breast cancer. Identification of patients at high risk of CVD is important to optimize CVD prevention and tailor breast cancer treatment.
Abstract Objective Ideally, clinical prediction models are generalizable to other patient groups. Unfortunately, they perform regularly worse when validated in new patients and are then often ...redeveloped. While the original prediction model usually has been developed on a large data set, redevelopment then often occurs on the smaller validation set. Recently, methods to update existing prediction models with the data of new patients have been proposed. We used an existing model that preoperatively predicts the risk of severe postoperative pain (SPP) to compare five updating methods. Study Design and Setting The model was tested and updated with a set of 752 new patients (274 36 with SPP). We studied the discrimination (ability to distinguish between patients with and without SPP) and calibration (agreement between the predicted risks and observed frequencies of SPP) of the five updated models in 283 other patients (100 35% with SPP). Results Simple recalibration methods improved the calibration to a similar extent as revision methods that made more extensive adjustments to the original model. Discrimination could not be improved by any of the methods. Conclusion When the performance is poor in new patients, updating methods can be applied to adjust the model, rather than to develop a new model.
ABSTRACT—Increased body weight is a strong risk factor for hypertension. A meta-analysis of randomized controlled trials was performed to estimate the effect of weight reduction on blood pressure ...overall and in population subgroups. Twenty-five randomized, controlled trials (comprising 34 strata) published between 1966 and 2002 with a total of 4874 participants were included. A random-effects model was used to account for heterogeneity among trials. A net weight reduction of −5.1 kg (95% confidence interval CI, −6.03 to −4.25) by means of energy restriction, increased physical activity, or both reduced systolic blood pressure by −4.44 mm Hg (95% CI, −5.93 to −2.95) and diastolic blood pressure by −3.57 mm Hg (95% CI, −4.88 to −2.25). Blood pressure reductions were −1.05 mm Hg (95% CI, −1.43 to −0.66) systolic and −0.92 mm Hg (95% CI, −1.28 to −0.55) diastolic when expressed per kilogram of weight loss. As expected, significantly larger blood pressure reductions were observed in populations with an average weight loss >5 kg than in populations with less weight loss, both for systolic (−6.63 mm Hg 95% CI, −8.43 to −4.82 vs −2.70 mm Hg 95% CI, −4.59 to −0.81) and diastolic (−5.12 mm Hg 95% CI, −6.48 to −3.75 vs −2.01 mm Hg 95% CI, −3.47 to −0.54) blood pressure. The effect on diastolic blood pressure was significantly larger in populations taking antihypertensive drugs than in untreated populations (−5.31 mm Hg 95% CI, −6.64 to −3.99 vs −2.91 mm Hg 95% CI, −3.66 to −2.16). This meta-analysis clearly shows that weight loss is important for the prevention and treatment of hypertension.
Prediction models tend to perform better on data on which the model was constructed than on new data. This difference in performance is an indication of the optimism in the apparent performance in ...the derivation set. For internal model validation, bootstrapping methods are recommended to provide biascorrected estimates of model performance. Results are often accepted without sufficient regard to the importance of external validation. This report illustrates the limitations of internal validation to determine generalizability of a diagnostic prediction model to future settings.
A prediction model for the presence of serious bacterial infections in children with fever without source was derived and validated internally using bootstrap resampling techniques. Subsequently, the model was validated externally.
In the derivation set (n=376), nine predictors were identified. The apparent area under the receiver operating characteristic curve (95% confidence interval) of the model was 0.83 (0.78–0.87) and 0.76 (0.67–0.85) after bootstrap correction. In the validation set (n=179) the performance was 0.57 (0.47–0.67).
For relatively small data sets, internal validation of prediction models by bootstrap techniques may not be sufficient and indicative for the model's performance in future patients. External validation is essential before implementing prediction models in clinical practice.
Guidelines for lifestyle and dietary modification in patients with coronary artery disease (CAD) are mainly supported by evidence from general population studies. CAD patients, however, differ from ...the general population in age (older) and treatment with preventive drugs. This review seeks to provide evidence for a prognostic benefit of lifestyle and dietary recommendations from studies in CAD patients.
A literature search was performed on the effect of lifestyle and dietary changes on mortality in CAD patients. Prospective cohort studies and randomized controlled trials of patients with established CAD were included if they reported all-causes mortality and had at least 6 months of follow-up. The effect estimates of smoking cessation (relative risk RR, 0.64; 95% CI, 0.58 to 0.71), increased physical activity (RR, 0.76; 95% CI, 0.59 to 0.98), and moderate alcohol use (RR, 0.80; 95% CI, 0.78 to 0.83) were studied most extensively. For the 6 dietary goals, data were too limited to provide reliable effect size estimates. Combinations of dietary changes were associated with reduced mortality (RR, 0.56; 95% CI, 0.42 to 0.74).
Available studies show convincingly the health benefits of lifestyle changes in CAD patients. Effect estimates of combined dietary changes look promising. Future studies should confirm these findings and assess the contribution of the individual dietary factors.
Aims/hypothesis The relationship between cognitive function, cardiovascular disease and premature death is not well established in patients with type 2 diabetes. We assessed the effects of cognitive ...function in 11,140 patients with type 2 diabetes who participated in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial. Furthermore, we tested whether level of cognitive function altered the beneficial effects of the BP-lowering and glycaemic-control regimens in the trial. Methods Cognitive function was assessed using the Mini Mental State Examination at baseline, and defined by scores 28-30 (‘normal', n = 8,689), 24-27 (‘mild dysfunction', n = 2,231) and <24 (‘severe dysfunction', n = 212). Risks of major cardiovascular events, death and hypoglycaemia and interactions with treatment were assessed using Cox proportional hazards analysis. Results Relative to normal function, both mild and severe cognitive dysfunction significantly increased the multiple-adjusted risks of major cardiovascular events (HR 1.27, 95% CI 1.11-1.46 and 1.42, 95% CI 1.01-1.99; both p < 0.05), cardiovascular death (1.41, 95% CI 1.16-1.71 and 1.56, 95% CI 0.99-2.46; both p ≤ 0.05) and all-cause death (1.33, 95% CI 1.16-1.54 and 1.50, 95% CI 1.06-2.12; both p < 0.03). Severe, but not mild, cognitive dysfunction increased the risk of severe hypoglycaemia (HR 2.10, 95% CI 1.14-3.87; p = 0.018). There was no evidence of heterogeneity of treatment effects on cardiovascular outcomes in subgroups defined by cognitive function at baseline. Conclusions/interpretation Cognitive dysfunction is an independent predictor of clinical outcomes in patients with type 2 diabetes, but does not modify the effects of BP lowering or glucose control on the risks of major cardiovascular events. Trial registration: ClinicalTrials.gov NCT00145925 Funding: Supported by grants from Servier and from the National Health and Medical Research Council of Australia.
Accumulating evidence suggests a sex-dependent role of circulating testosterone in the metabolic syndrome (MetS).
We conducted a meta-analysis of observational studies (PubMed and EMBASE-1 May 2010) ...relating MetS to determinants of testosterone status total testosterone (TT), free testosterone (FT) and sex hormone-binding globulin (SHBG).
A total of 52 studies were identified, comprising 22 043 men and 7839 women and presenting relative risk (RR) estimates or hormone levels for subjects with and without MetS. Endogenous TT and FT levels were lower in men with MetS TT mean difference = -2.64 nmol/l, 95% confidence interval (CI) -2.95 to -2.32; FT standardized mean difference = -0.26 pmol/l, 95% CI -0.39 to -0.13 and higher in women with MetS (TT mean difference = 0.14 nmol/l, 95% CI 0.07-0.20; FT standardized mean difference = 0.52 pmol/l, 95% CI 0.33-0.71) compared with those without. Similarly, men with higher TT levels had a lower MetS risk (RR estimate = 0.38, 95% CI 0.28-0.50) whereas higher TT levels increased the risk of MetS in women (RR estimate = 1.68, 95% CI 1.15-2.45). In both sexes, higher SHBG levels were associated with a reduced risk (men: RR estimate = 0.29, 95% CI 0.21-0.41; women: RR estimate = 0.30, 95% CI 0.21-0.42).
This meta-analysis supports the presence of a sex-dependent association between testosterone and MetS: TT and FT levels are lower in men with MetS, whereas they are higher in women with MetS. There are no indications for a sex-specific association between SHBG and MetS. In both men and women, MetS is associated with lower SHBG levels.
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