Impact of randomized trials comparing conventional and endovascular abdominal aortic aneurysm repair on clinical practice.

PURPOSE: To report a retrospective study into the effects of trials on clinical decision-making regarding abdominal aortic aneurysm (AAA) patients suitable for both conventional open (OR) and endovascular aneurysm repair (EVAR). METHODS: A questionnaire was sent to 1400 Dutch surgeons and trainees. Interviewees had to choose between OR and EVAR for AAA patients with and without comorbidity. Specifically, their preferences before and after the publication of 2 randomized trials (EVAR-1 and DREAM) were polled. RESULTS: Of the 524 (37%) questionnaires returned, 223 (43%) respondents treated AAA patients. Before publication of the trials, 160 (72%) preferred OR for the patient without comorbidity and 169 (76%) preferred EVAR for the patient with comorbidity. In total, 72 (32%) respondents changed their preference after the trials were published; however, there was no overall major shift. Focusing on the different cases revealed that the OR preference was significantly enhanced for the patient without comorbidity (p<0.01), while the EVAR preference was significantly enhanced for the patient with comorbidity (p<0.05). CONCLUSION: The randomized trials have not induced major overall changes in surgical decision-making for AAA patients suitable for both EVAR and OR.     

Walking exercise in patients with intermittent claudication. Experience in routine clinical practice.

BACKGROUND: In patients with intermittent claudication, exercise in the form of walking is effective in reducing pain and maximising achievable walking distance. However, data are lacking on the implementation of walking exercise in these patients. AIMS: To explore the current behaviour and views of patients with intermittent claudication towards taking walking exercise. DESIGN OF STUDY: Postal questionnaire and focus group meetings. SETTING: Two academic general practice networks (Utrecht and Maastricht Universities) in The Netherlands. METHOD: Three hundred and seventy-five patients with intermittent claudication, selected from the files of general practitioners participating in two academic general practice networks, were sent a postal questionnaire; 216 (58%) were returned. Nine of these responders also attended a focus group meeting. RESULTS: Seventy per cent (151/216) of the patients reported having received advice about walking exercise. If specified, the advice given most often recommended walking in the local neighbourhood (56%, 84/151). Fifty-two per cent (113/216) of all patients actually performed walking exercise and only 32%of them received any kind of supervision. Among the barriers for taking walking exercise, 'comorbidity', 'lack of (specific) advice' and 'lack of supervision' were often mentioned. Among the stimuli to start and continue walking, 'following the doctor's advice', 'relief of complaints' and 'a better general condition' were often mentioned by patients. CONCLUSIONS: Walking exercise was not carried out by almost half of patients with intermittent claudication in this study. Lack of specific advice and supervision were found to be important barriers to taking walking exercise.     

Does the beneficial effect of HRT on endothelial function depend on lipid changes

OBJECTIVES: To determine whether improvement in endothelial function of the brachial artery observed in women treated with hormone replacement therapy (HRT) may be explained by changes in lipid profile or blood pressure, information was used obtained in a single-centre, randomised, double blind, placebo-controlled trial. METHODS: Hundred-and-five healthy postmenopausal women, aged 50-65 years, were treated with 0.625 mg conjugated equine estrogens (CEE) combined with 2.5 mg medroxyprogesterone acetate (MPA) (CEE+MPA), 2.5 mg tibolone or placebo for 3 months. At baseline and after 3 months, endothelial function was assessed using flow-mediated dilatation (FMD) and nitro glycerine-mediated dilatation (NMD). Furthermore, lipids were measured. Multivariate linear regression analysis was applied to address the research question. RESULTS: Treatment with CEE+MPA resulted in an improvement in FMD of 2.0% (95% CI: -0.1; 4.1). CEE/MPA reduced total cholesterol with 13% (95% CI: -18%; -7%), LDL-cholesterol with 23% (95% CI: -30%; -15%) and lipoprotein(a) (Lp(a)) with 14% (95% CI: -26%; -2%). The magnitude of the relation of CEE/MPA with endothelial function was attenuated to from 2.0 to 1.6% when change in Lp(a) was taken into account. Adjustments for other lipids or blood pressure did not attenuate the association. CONCLUSIONS: The improvement in endothelial function in postmenopausal women treated with CEE+MPA appears to be partially mediated by change in Lp(a), and apparently not by changes in other lipids.     

Soy isoflavones, body composition, and physical performance

OBJECTIVES: Physiologic changes, occurring during the process of aging, can have serious health consequences, such as increased risk of chronic disease and disability. Decline in estradiol levels after menopause is hypothesized to contribute to this risk. Thus, hormone therapy (HT) might prevent or delay those changes. However, HT has serious side effects and alternative approaches are needed. METHODS: We performed a 12-month double-blind randomized trial comparing soy protein containing 99mg isoflavones (aglycone weights) with milk protein (placebo) daily in 202 postmenopausal women aged 60-75 years. Endpoints were body composition, and physical performance. Randomization resulted in reasonable well-balanced groups, 153 (76%) women completed the trial. Compliance was good (plasma genistein levels 55 +/- 101 and 1259 +/- 1610 nmol/L for placebo and soy group, respectively). The changes in the endpoints during the intervention period among the two intervention groups were analyzed. RESULTS: Body mass index (BMI) and waist-to-hip ratio did not change during intervention. Handgrip strength at the final visit was slightly worse in the soy group compared to the placebo group (-0.45 kg (95% C.I.: -2.5, 1.6 kg; p = 0.7), but this difference was not statistically significant. Self-reported functional status, mobility and physical performance, all slightly improved during intervention but there were no differences between the groups. CONCLUSIONS: The results of the present trial do not support the view that soy isoflavones have favorable effects on body composition and physical performance in postmenopausal women.     

Patient and public involvement cultures and the perceived impact in the vulnerable context of palliative care: A qualitative study

BackgroundCultural values are crucial to the practice and impact of patient and public involvement (PPI) in research.ObjectiveTo understand different PPI cultures among research teams and the impacts of PPI associated with each culture type.DesignA participatory action research design.Setting and participantsThe setting was 10 palliative care research projects. Seventeen patients and members of the public and 31 researchers participated.InterventionA programme consisting of four components: (1) training and coaching of patients and the public to prepare them for participation in research, (2) tailored coaching of the 10 research teams over 12‐18 months, (3) a community of practice, and (4) a qualitative evaluation.ResultsWe identified three cultures types: relationship cultures, task cultures, and control cultures. We identified four areas of impact: the project aim became more relevant to the target audience, methodological reliability increased, the research products were better able to reach the public, and the awareness increased, associated with behavioural changes, among researchers regarding PPI.DiscussionA relationship culture appears to be long‐lasting due to impacting the behaviours of the researchers during future projects. Different cultural types require different types of patients and researcher participants, assigned to different tasks.ConclusionsFurther research remains necessary to investigate the support required by researchers to enable relationship‐ and task‐oriented PPI cultures.Patient or public contributionPatient advocates and representatives contributed to our research team throughout the entire research process, as well as within the 10 implementation projects.     

Classification of heart failure in population based research: An assessment of six heart failure scores

Several scores based on symptoms and signs have been developed to assess the presence of heart failure. The goal of this study was to compare six heart failure scores in non-hospitalised subjects and to determine their usefulness in population based research. The scores were applied to 54 participants of a population based study. All underwent a complete medical examination, including chest X-ray, electrocardiography and Doppler echocardiography. Using all information available, a cardiologist, unaware of the results of the scores, clinically classified participants as having no, possible or definite heart failure. Sensitivity, specificity, predictive values and receiver operating characteristics were calculated, using the cardiologist's assessment as a gold standard. The cardiologist judged definite or possible heart failure to be present in 17 persons. All scores had a high sensitivity for the detection of definite heart failure, whereas the study of men born in 1913 and Walma's score had the highest sensitivity for the combination of possible and definite heart failure. Gheorgiade's and the Boston score had the highest positive predictive values. In conclusion, five of the six scores we studied are broadly similar in the detection of heart failure. The men born in 1913 score relies heavily on the assessment of dyspnea, resulting in a relatively large number of false positives. Although the scores are useful in detecting manifest heart failure, objective measurements of cardiac function appear necessary to reduce the false positive rate and accurately detect early stages of heart failure.     

Concomitant radiotherapy and hyperthermia for primary carcinoma of the vagina: a cohort study

OBJECTIVE: To evaluate the supplementary value of adding hyperthermia to radiotherapy in patients with primary vaginal cancer. STUDY DESIGN: Cohort of 44 patients diagnosed with primary vaginal cancer between 1990 and 2002 was assessed. Survival rates and median survival of patients with primary vaginal cancer undergoing radiotherapy with and without hyperthermia were compared. Hyperthermia was solely added to radiotherapy in case of a tumor size >4 cm in diameter for FIGO stage III disease. RESULTS: The calculated overall 5-year survival of primary vaginal cancer was 63%. In comparison to histologic high grade tumors, higher survival rates for histologic low grade tumors were calculated. For FIGO stage III of disease, the addition of hyperthermia to radiotherapy for tumors >4 cm in diameter resulted similar survival rates and median survival when compared to those achieved by radiotherapy as monotherapy in tumors of <4 cm in diameter. CONCLUSIONS: The addition of hyperthermia to radiotherapy might result in better survival rates in primary vaginal cancer for tumors >4 cm in diameter. The supplementary effect of hyperthermia to radiotherapy may be a feasible and beneficial approach in the treatment of vaginal cancer.     

Permanent Cortical Blindness After Bronchial Artery Embolization

A 35-year-old female with a known medical history of cystic fibrosis was admitted to our institution for massive hemoptysis. CTA depicted a hypertrophied bronchial artery to the right upper lobe and showed signs of recent bleeding at that location. Bronchial artery embolization (BAE) was performed with gelfoam slurry, because pronounced shunting to the pulmonary artery was present. Immediately after BAE, the patient developed bilateral cortical blindness. Control angiography showed an initially not opacified anastomosis between the embolized bronchial artery and the right subclavian artery, near to the origin of the right vertebral artery. Cessation of outflow in the bronchial circulation reversed the flow through the anastomosis and allowed for spill of embolization material into the posterior circulation. Unfortunately the cortical blindness presented was permanent.