Pneumococcal vaccination of the elderly: do we need another trial?
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Aged↗
Biomedical subjects
E Buskens
Publications and source records attributed to E Buskens.
['Medical technology assessment'; more than just efficacy].
'Medical technology assessment' means investigating the developments, costs and effects of medical technologies. Practising physicians increasingly are confronted with consequences of management based on such research results. In order to follow and participate in the discussion they should be aware of this and know the jargon. In policy problems, measures of effect in natural units (e.g. cardiovascular mortality) offer advantages over measures of clinical findings (e.g. decrease of the serum cholesterol levels). Survival in various health states and disorders can be compared by multiplying the number of life years gained by a factor for the quality of life in those years. Costs are usually expressed in monetary terms. These may be calculated as direct medical costs on the basis of fees or actual costs for society. The latter is the case when the balancing is based on a societal perspective. The societal perspective enables a more objective assessment of health effects than when a patient perspective is used. 'Incremental cost effectiveness' expresses where extra expenditures will have maximum effect, and bears higher relevance for policy decisions than mean costs per unit of effect. Immaterial matters are more difficult to assess, but should nevertheless be considered in selecting the policy to be implemented.
Cost-Benefit Analysis↗
The Octopus Study: rationale and design of two randomized trials on medical effectiveness, safety, and cost-effectiveness of bypass surgery on the beating heart.
The Octopus Study consists of two multicenter randomized clinical trials in which coronary artery bypass grafting on the beating heart (off-pump CABG) using the Utrecht Octopus Method is compared to intracoronary stent implantation and conventional CABG. The primary endpoint in the comparison of off-pump CABG versus stent implantation (OctoStent Trial) is medical effectiveness (i.e., absence of reintervention and major adverse cardiac and cerebrovascular events at 1 year after treatment). The primary endpoint in the comparison of off-pump CABG versus conventional CABG (OctoPump Trial) is cerebral safety (i.e., absence of cognitive deficits and cerebrovascular events at 3 months after treatment). Secondary endpoints in both trials include presence and severity of angina, quality of life, exercise capacity, and cost-effectiveness. A total of 560 patients will be enrolled. A random sample of 210 patients will undergo repeat angiography at 1 year to assess angiographic restenosis rate and graft patency. Including 1-year follow-up, the study will last for 3 years. Control Clin Trials 2000;21:595-609
Angioplasty, Balloon, Coronary↗
Diagnostic accuracy of large-core needle biopsy for nonpalpable breast disease: a meta-analysis.
For the evaluation of non-palpable lesions of the breast, image-guided large-core needle biopsies are increasingly replacing needle-localized open breast biopsies. In this study, the diagnostic accuracy of this minimally invasive technique was evaluated by reviewing the available literature. Five cohort studies were included in a meta-analysis. Sensitivity rate, histological agreement between needle biopsy and subsequent surgery or long-term mammographic follow-up and clinical consequences for different disease prevalences were assessed. The sensitivity rate of large-core needle biopsy for the diagnosis of breast cancer was high (97%). The reclassified agreement rate between core biopsy and subsequent surgical biopsy or long-term mammographic follow-up was also high (94%). In case of 20% breast cancer prevalence among women referred after screening (as in the US), the risk of breast cancer despite benign large-core needle biopsy result is less than 1%. In European countries, however, prevalence of breast cancer among referred women is 60-70%. This would result in a risk of breast cancer despite benign large-core needle biopsy result of 4-6%. The results of this meta-analysis indicate that the image guided large-core needle biopsy is a promising alternative for the needle localized breast biopsy. However, additional research is needed to explore the limiting factors of the technique. Without such detailed knowledge, a benign histological diagnosis on large-core needle biopsy in countries with high prevalence of malignancy among referred women should be interpreted with caution.
Biopsy, Needle↗
Perimesencephalic hemorrhage and CT angiography: A decision analysis.
BACKGROUND AND PURPOSE: The method of choice for detecting or excluding a vertebrobasilar aneurysm still is a matter of debate in patients with a characteristically perimesencephalic pattern of subarachnoid hemorrhage (SAH) on CT. We used decision analysis to compare possible diagnostic strategies in these patients. METHODS: A decision analytic model was developed to evaluate the effect of 4 different diagnostic strategies following a perimesencephalic pattern of SAH on CT: 1, no further investigation; 2, digital subtraction angiography (DSA) by catheter; 3, CT angiography as initial modality, not followed by DSA if negative; and 4, CT angiography as initial modality, followed by DSA. We used a 4% prevalence of a vertebrobasilar aneurysm given a perimesencephalic pattern of hemorrhage, a 97% sensitivity and specificity of CT angiography, and a 99.5% sensitivity and 100% specificity of DSA. In a prospectively collected series, the complication rate from DSA in patients with a perimesencephalic pattern of hemorrhage was 2.6%. We calculated the expected utility of each of the 4 diagnostic options and used sensitivity analyses to examine the influence of the plausible ranges of the various estimates used. RESULTS: The expected utilities were 99.09 for CT angiography only, 98.96 for no further investigation, 98.22 for DSA, and 96.34 for CT angiography plus DSA. The results of the sensitivity analysis indicate that over a wide range of assumptions, CT angiography only is the most beneficial option. Only when the complication rate of catheter angiography is <0.2% is DSA the preferred strategy. CONCLUSIONS: Our decision analysis shows that in patients with a perimesencephalic pattern of hemorrhage on CT, CT angiography only is the best diagnostic strategy. DSA can be omitted in patients with a perimesencephalic pattern of hemorrhage and a negative CT angiogram.
Angiography, Digital Subtraction↗
Arterial stenting and balloon angioplasty in ostial atherosclerotic renovascular disease: a randomised trial.
BACKGROUND: Percutaneous transluminal angioplasty (PTA) for ostial atherosclerotic renal-artery stenosis has poor results. Angioplasty with stent placement (PTAS) may be more effective. We undertook a randomised prospective study to compare PTA with PTAS in patients with ostial atherosclerotic renal-artery stenosis. METHODS: Patients with ostial atherosclerotic renal-artery stenosis were assigned to receive PTA or PTAS. Secondary PTAS was allowed if PTA failed immediately or during 6 months' follow-up. Analysis was by intention to treat. FINDINGS: 42 patients were assigned PTA and 43 were assigned PTAS, but one patient in the PTAS group was excluded from the study. Primary success rate (<50% residual stenosis) of PTA was 57% (24 patients) compared with 88% (37 patients) for PTAS (difference between groups 31% [95% CI 12-50]). Complications were similar. At 6 months, the primary patency rate was 29% (12 patients) for PTA, and 75% (30 patients) for PTAS (46% [24-68]). Restenosis after a successful primary procedure occurred in 48% of patients for PTA and 14% for PTAS (34% [11-58]). 12 patients underwent secondary stenting for primary or late failure of PTA within the follow-up period: success was similar to that of primary PTAS. Evaluation based on intention to treat showed no difference in clinical results at six months for PTA or PTAS. INTERPRETATION: PTAS is a better technique than PTA to achieve vessel patency in ostial atherosclerotic renal-artery stenosis. Primary PTAS and primary PTA plus PTAS as rescue therapy have similar outcomes. However, the burden of reintervention after PTA outweighs the potential saving in stents, so primary PTAS is a better approach to use.
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EuroQol values for economic modeling quality of life after infrainguinal bypass grafting surgery: a rectification.
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Adult↗
Quality of life after infrainguinal bypass grafting surgery. Dutch Bypass Oral Anticoagulants or Aspirin (BOA) Study Group.
PURPOSE: The purpose of this study was to compare quality of life in patients with and without various ischemic complications after infrainguinal bypass grafting surgery for occlusive vascular disease. METHODS: A sample of patients (n = 746) randomized in the Dutch BOA study (n = 2645), a multicenter trial that compared the effectiveness of oral anticoagulant therapy with aspirin in the prevention of infrainguinal bypass graft occlusions, was entered in this study. On the basis of clinical outcomes of the trial, the patients were grouped as follows: patients with patent grafts (n = 409); patients with nontreated graft occlusions, subdivided into an asymptomatic group (n = 32) and a symptomatic group (n = 65); patients with subsequent revascularizations (n = 194); patients with amputations (n = 36); and patients with failed secondary revascularizations followed by secondary amputation (n = 38). In case an outcome event occurred, the patients were regrouped accordingly. Every half year, the patients completed a Short Form-36 and a EuroQol questionnaire. A multilevel model was used for repeated measure analysis. RESULTS: The mean follow-up time was 21 months. The quality of life in patients with nontreated asymptomatic occlusions was roughly similar to the quality of life in patients with patent grafts. Patients with symptomatic nontreated occlusions had the lowest outcome with regard to pain as compared with the other groups. Furthermore, physical and social functioning was lower for these patients than for patients with patent grafts. Revascularizations, successful or not, negatively affected pain, social functioning, and physical and emotional role. After successful revascularization, some improvement was observed in pain, physical and social functioning, and general and mental health as compared with the group with nontreated symptomatic occlusions. Amputation deteriorated physical functioning strikingly, especially after failed secondary revascularization. These patients also had the lowest scores of all the groups in the dimensions of social functioning, physical and emotional role, and mental health. EuroQol score showed deterioration of quality of life after all events, except for asymptomatic occlusions. The same patterns emerged if we stratified our analysis according to the indication for the initial operation: claudication or limb salvage. Quality of life was constant over time in all the groups in the observed period. CONCLUSION: Quality of life in patients with asymptomatic occluded grafts is similar to quality of life in patients with patent grafts. Revascularization of symptomatic occluded grafts improves quality of life to a certain extent. Amputation, in particular after failed secondary revascularization, seemed to be the lowest possible outcome. The results of the Short Form-36 and EuroQol measurements were in line with the clinical expectations. The association of disease severity with scores on the instruments supports the construct validity of these outcome measures for an objective assessment of quality of life in controlled studies.
Aged↗
Validation and value of an enzyme-linked immunosorbent assay for Helicobacter pylori in primary care.
BACKGROUND: Helicobacter pylori infection is related to gastric ulcer and carcinoma. In this study we validated the Pyloriset EIA-G New (a quantitative enzyme-linked immunosorbent assay) in a general practice population. The implications of eradication in case of a positive result were assessed. METHODS: One hundred and fifteen subsequent patients, enrolled in a randomized clinical trial evaluating the optimal strategy for treatment of dyspeptic patients in primary care, were included. Using biopsy as gold standard, we calculated the sensitivity and specificity of the test. RESULTS: The sensitivity and specificity of the test were 91% (95% confidence interval (CI) = 86% to 97%) and 78% (95% CI = 75% to 82%), respectively. Eradication of H. pylori would be indicated in 8 of 57 positive patients, since these actually had a peptic ulcer. In the other 49 patients eradication therapy would be unnecessary. CONCLUSION: The Pyloriset EIA-G New is a reliable test in primary care. However, a serologic test-and-treat strategy in all dyspeptic patients cannot be recommended.
Adult↗
MR angiography as a screening tool for intracranial aneurysms: feasibility, test characteristics, and interobserver agreement.
OBJECTIVE: MR angiography may be an appropriate tool to screen for unruptured intracranial aneurysms. Feasibility, test characteristics, and interobserver agreement in evaluation of MR angiograms were assessed by members of the MARS (Magnetic resonance Angiography in Relatives of patients with Subarachnoid hemorrhage) Study Group. SUBJECTS AND METHODS: We screened 626 first-degree relatives of a consecutive series of 193 patients with subarachnoid hemorrhage examined at two institutions. We used MR imaging and MR angiography (three-dimensional time-of-flight imaging at both institutions and additional three-dimensional phase-contrast imaging at one institution). Three observers independently assessed the MR angiograms. Conventional angiography was performed in relatives with possible or definite aneurysms on MR angiography and was considered the standard of reference. RESULTS: Thirty-three aneurysms were found in 25 (4%; 95% confidence interval [CI], 3-6%) of 626 relatives. Thirteen (8%) of 169 relatives who refused screening had MR-related reasons; an additional six persons could not be screened because of contraindications for MR imaging (pregnancy, n = 1; claustrophobia, n = 5). The positive predictive value of MR angiography was 100% (95% CI, 79-100%) for "definite" aneurysms and 58% (95% CI, 28-85%) for "possible" aneurysms. Sensitivity of MR angiography was estimated at 83% (95% CI, 65-94%) and specificity at 97% (95% CI, 94-98%). Interobserver agreement in the evaluation of MR angiograms was poor (kappa < .30), probably because different diagnostic strategies used by individual observers resulted in different use of the assessment category "possible aneurysm." CONCLUSION: MR angiography is a feasible screening tool for detection of intracranial aneurysms. Positive predictive value, sensitivity, and specificity are acceptable when at least two neuroradiologists independently assess MR angiograms.
Adult↗
Integrated visualization of functional and anatomic brain data: a validation study.
UNLABELLED: Two-dimensional SPECT display and three methods for integrated visualization of SPECT and MRI patient data are evaluated in a multiobserver study to determine whether localization of functional data can be improved by adding anatomical information to the display. METHODS: SPECT and MRI data of 30 patients were gathered and presented using four types of display: one of SPECT in isolation, two integrated two-dimensional displays and one integrated three-dimensional display. Cold and hot spots in the peripheral cortex were preselected and indicated on black-and-white hard copies of the image data. Nuclear medicine physicians were asked to assign the corresponding spots in the image data on the computer screen to a lobe and a gyrus and give a confidence rating for both localizations. Interobserver agreement using kappa statistics and average confidence ratings were assessed to interpret the reported observations. RESULTS: Both the interobserver agreement and the confidence of the observers were greater for the integrated two-dimensional displays than for the two-dimensional SPECT display. An additional increase in agreement and confidence was seen with the integrated three-dimensional display. CONCLUSION: Integrated display of SPECT and MR brain images provides better localization of cerebral blood perfusion abnormalities in the peripheral cortex in relation to the anatomy of the brain than single-modality display and increases the confidence of the observer.
Cerebral Cortex↗
Risk-assessment tools in the prevention of pressure ulcers.
Some screening tools exist for assessing increased risk of the development of pressure ulcers, but none of these tools has undergone actual testing for validity and predictive value. This is important in clinical practice because the combination of high sensitivity and rather low specificity implies that the number of patients at increased risk is overestimated and thus overtreated (i.e., unnecessary preventive measures are taken). Risk scores are usually composed of items considered to influence the development of pressure ulcers. Although for some scoring systems attempts have been made to enhance specificity by changing the cutoff points or the relative value of individual items, good results have not been achieved. The influence that individual items have on the development of pressure ulcers and the impact of this influence on score outcomes has not yet been established. In this study, 65 patients with and 58 patients without pressure ulcers were compared using all of the known risk factors analyzed by multivariate logistic regression. We found that only the Norton, Douglas, and Dutch Consensus Meeting scoring systems appeared to predict the development of pressure ulcers. Also, it appeared that incontinence for urine and the presence of both neurologic disorders and friction forces to the skin effectively predict the development of pressure ulcers. Considering the important implications of this study, a larger study--consisting of several thousand patients--should be performed to assess in more detail the variables currently perceived as risk factors and construct and evaluate a scoring system based on these results.
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A cost-effectiveness analysis of colorectal screening of hereditary nonpolyposis colorectal carcinoma gene carriers.
BACKGROUND: It has been estimated that the prevalence of carriers of a mutated mismatch repair (MMR) gene among the general population in Western countries is between 5 and 50 per 10,000. These carriers have a risk of >85% of developing colorectal carcinoma (CRC) and therefore need careful follow-up. The objective of this study was to analyze the cost-effectiveness of CRC surveillance of carriers of a mutated MMR gene. METHODS: The authors constructed a model to estimate the potential health effects (life expectancy) and healthcare costs of two strategies: 1) surveillance, with colonoscopy every 2-3 years, and 2) no CRC surveillance. Estimates of the lifetime risk of developing CRC and the stage distribution of CRC for symptomatic patients were derived from the Dutch hereditary nonpolyposis colorectal carcinoma (HNPCC) registry. The CRC stage specific relative survival rates and the effectiveness of surveillance in preventing or detecting cancer early were based on Finnish studies. The costs of surveillance and treatment were derived from recent American studies. RESULTS: The results showed that 1) surveillance of gene carriers led to an increase in life expectancy of 7 years, and 2) the costs of surveillance under a wide range of assumptions are less than the costs of no CRC surveillance. CONCLUSIONS: CRC surveillance of HNPCC gene carriers appears to be effective and considerably less costly than no CRC surveillance and therefore deserves to be supported by governmental agencies and health insurance organizations.
Adult↗
Is immunising all patients with chronic lung disease in the community against influenza cost effective? Evidence from a general practice based clinical prospective cohort study in Utrecht, The Netherlands.
STUDY OBJECTIVE: There is little information on the potential benefit of immunising all patients with chronic lung disease in the community against influenza. The clinical effectiveness and economic benefit was established of the influenza vaccination programme in a general practice based cohort of adult patients with chronic lung disease followed up during the 1995/96 influenza A epidemic. DESIGN: A prospective cohort study from October 1995 to March 1996. SETTING: The study was undertaken in the Utrecht General Practices Network with six large group practices, covering a total population of approximately 50,000 patients in the Netherlands. PATIENTS: Computerised medical records of 1696 patients with chronic lung disease aged over 18 years with an indication for vaccination according to the Dutch GP guidelines were reviewed. MAIN RESULTS: The overall attack rate of any complication, including all cause death, low respiratory tract infection, and acute cardiac disease was 15%. Exacerbations of lung disease were most frequent (13%). Death, pneumonia, and acute cardiac disease were mainly limited to patients > or = 65 years. No effectiveness of the immunisation programme could be established in patients 18-64 years (n = 1066), after controlling for baseline prognosis in multivariable logistic regression analysis. In vaccinees > or = 65 years (n = 630), the occurrence of any complication was reduced by 50% (95% CI 17, 70%). The economic benefit was estimated at 50 Pounds per elderly vaccinee. CONCLUSIONS: This study suggests that in the Netherlands immunisation of elderly patients with chronic lung disease against influenza is effective and cost-saving, hence these patients should be given high priority. More, preferably experimental, studies are needed to establish whether adult lung patients under 65 years in the community will also benefit from vaccination.
Adult↗
Mayo and NINDS scales for assessment of tendon reflexes: between observer agreement and implications for communication.
The purpose of this study was to assess the between observer reliability of two standard notation scales for grading tendon reflexes, The Mayo Clinic scale and the NINDS scale. In a university department of neurology two or three physicians judged the biceps, triceps, knee, and ankle tendon reflexes in two groups of 50 patients using either scale. The interobserver agreement was assessed by means of kappa statistics. The agreement among doctors was never better than "fair" for both scales (highest kappa value 0.35). A verbal description rather than a codified scale may improve communication among doctors.
Adult↗
Psychosocial intervention following suicide attempt: a systematic review of treatment interventions.
Repeated suicide attempts are a common problem. However, few randomized controlled studies on the treatment of suicide attempters have been described. Although some of these studies showed beneficial effects on measures of well-being, none of them demonstrated lasting positive effects on repeated suicidal behaviour. In an attempt to analyse the results obtained, a systematic review of randomized controlled trials of interventions for suicide attempters is presented. The literature was gathered by means of a CD-ROM literature reference search (MEDLINE/PSYCLIT). Subsequently, information on study design and treatment efficacy was abstracted. Studies that were homogeneous with regard to therapeutic principles were reviewed accordingly, and pooled analyses were performed. Meta-analyses accounted for inter-study variance (random-effects model) to estimate a common-effect measure (relative risk). Systematic review of the data showed considerable differences in both study design and therapeutic protocols. In view of these differences, a single pooled analysis of all studies appeared to be unfeasible. A pooled analysis of studies that focus on psychiatric management of poor compliance showed no significant effect on the repetition of suicide attempts. Similarly, studies of psychosocial crisis intervention, as well as studies of guaranteed in-patient shelter in cases of emergency, did not show a significant reduction in repeated suicide attempts. However, the pooled results of four studies on cognitive-behavioural therapies showed a significant preventive effect on repeated suicide attempts. At present, only the cognitive-behavioural approach appears to have a beneficial effect on repeated suicide attempts. However, because of methodological variability, the results obtained may be too optimistic. Additional research is required to establish the merits of this type of intervention.
Analysis of Variance↗
Decision analysis in the management of duodenal adenomatosis in familial adenomatous polyposis.
BACKGROUND: Patients with familial adenomatous polyposis are not only at high risk of developing adenomas in the colorectum but a substantial number of patients also develop polyps in the duodenum. Because treatment of duodenal polyps is extremely difficult and it is unknown how many patients ultimately develop duodenal cancer, the value of surveillance of the upper digestive tract is uncertain. AIMS: (1) To assess the cumulative risk of duodenal cancer in a large series of polyposis patients. (2) To develop a decision model to establish whether surveillance would lead to increased life expectancy. METHODS: Risk analysis was performed in 155 Dutch polyposis families including 601 polyposis patients, and 142 Danish families including 376 patients. Observation time was from birth until date of last contact, death, diagnosis of duodenal cancer, or closing date of the study. RESULTS: Seven Dutch and five Danish patients developed duodenal cancer. The lifetime risk of developing this cancer by the age of 70 was 4% (95% confidence interval 1-7%) in the Dutch series and 3% (95% confidence interval 0-6%) in the Danish series. Decision analysis showed that surveillance led to an increase in life expectancy by seven months. CONCLUSIONS: Surveillance of the upper digestive tract led to a moderate gain in life expectancy. Future studies should evaluate whether this increase in life expectancy outweighs the morbidity of endoscopic examination and proximal pancreaticoduodenectomy.
Adenomatous Polyposis Coli↗
Intensive in-patient and community intervention versus routine care after attempted suicide. A randomised controlled intervention study.
BACKGROUND: A randomised clinical trial was carried out in suicide attempters to assess clinical efficacy of an intensive psychosocial intervention compared with treatment as usual. METHOD: Two hundred and seventy-four suicide attempters presenting for medical treatment were randomly assigned to either intensive psychosocial treatment or 'care as usual'. Intensive psychosocial treatment consisted of brief admission to a special crisis-intervention unit and problem-solving aftercare. 'Care as usual' included any form of treatment the assessing clinicians thought appropriate. Psychological well-being was evaluated by the SCL-90 and the Hopelessness Scale at 3, 6 and 12 months following entry in the study. RESULTS: No differences in outcome were found. The probability of repeat suicide attempts in the 12-month follow-up was 0.17 for patients in the experimental group and 0.15 for the control group. There were no differences in ratings on the SCL-90 and the Hopelessness Scale. Patients in the experimental group attended significantly more out-patient treatment sessions. CONCLUSIONS: General implementation of an intensive in-patient and community intervention programme for suicide attempters does not seem justified.
Adult↗