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Selected AbstractsEffect of the correction for noncompliance and contamination on the estimated reduction of metastatic prostate cancer within a randomized screening trial (ERSPC section Rotterdam)INTERNATIONAL JOURNAL OF CANCER, Issue 11 2010Melissa Kerkhof Abstract The European Randomized study of Screening for Prostate Cancer (ERSPC) has recently reported a 20% reduction in death from prostate cancer in a population-based prostate cancer screening (core age group: 55,69 years of age). The effect of screening may be diluted by noncompliance in the screening arm and contamination by PSA testing in the control arm. The purpose is to analyze the effect of prostate cancer screening on the incidence of metastatic prostate cancer, both with and without adjustment for noncompliance and contamination. We analyzed the occurrence of metastases in 42,376 men aged 55,75 years who were randomized in the Rotterdam section of the ERSPC between 1993 and 1999. Contamination adjustment was based on follow-up findings and questionnaire data from all men in the control group who developed prostate cancer and from a random sample of 291 men without cancer who had a PSA test. Prostate cancer screening significantly reduced the occurrence of metastatic prostate cancer in the intention-to-screen analysis [RR 0.75, 95% CI 0.59,0.95, p = 0.02] and more so in adjusted analyses; contamination adjusted RR 0.73, 95% CI 0.56,0.96; noncompliance adjusted RR 0.72, 95% CI 0.55,0.95 and fully adjusted analysis RR 0.68, 95% CI 0.49,0.94, p = 0.02. In the population of ERSPC Rotterdam (N = 42,376 men), screening reduces the risk to be diagnosed with metastatic prostate cancer considerably on population level, an effect which is even more pronounced in men who are in fact screened. [source] Biological aggressiveness of prostate cancer in the Finnish screening trialINTERNATIONAL JOURNAL OF CANCER, Issue 3 2009Marita Laurila Abstract Prostate cancer aggressiveness was evaluated based on pathologic characterization of cases detected in the Finnish prostate cancer screening trial. The trial population consists of 80,458 men aged 55,67 years. A total of 32,000 men were randomized to the screening arm. The remaining 48,000 men formed the control arm. The interval cases and cancers among nonparticipants and in the control arm were identified from the Finnish Cancer Registry. Random samples were selected from screen-detected cases (126 of 543 in the first and 133 of 508 in the second round) and control arm cancers (133 out of 863), in addition to all 92 interval cancers and 106 cases among nonparticipants. All the biopsies were regraded according to the Gleason system. The expression of the proliferation antigen Ki-67 was determined in 479 cases (72%). More than half of the tumors diagnosed in the first round of screening were high-grade cancers (Gleason 7 or higher). In the second round, the proportion of low-grade cancers increased from 47% to 70%. Cancers in the screening arm were more commonly focal and fewer bilateral cancers were detected. The cancers among nonparticipants were the most aggressive group. The aggressiveness of the interval cancers was between the cancers detected in the first and the second round. Our results indicate that prostate cancers detected through screening are less biologically aggressive. This was most notable after the first screening round. Nonparticipants had more aggressive cancers. © 2008 Wiley-Liss, Inc. [source] Long-Term Effectiveness of Screening for Hearing Loss: The Screening for Auditory Impairment,Which Hearing Assessment Test (SAI-WHAT) Randomized TrialJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 3 2010Bevan Yueh MD OBJECTIVES: To evaluate the effect of hearing screening on long-term hearing outcomes in a general population of older veterans. DESIGN: Hearing loss in the elderly is underdetected and undertreated. Routine hearing screening has been proposed, but it is not clear whether screening identifies patients who are sufficiently motivated to adhere to treatment. A four-arm randomized clinical trial was conducted to compare three screening strategies with no screening in 2,305 older veterans seeking general medical care. SETTING: Veterans Affairs Puget Sound Health Care System. INTERVENTIONS: The screening strategies were a tone-emitting otoscope, a widely used questionnaire about hearing handicap, and a combination of both tools. MEASUREMENTS: Hearing aid use 1 year after screening. RESULTS: Of participants who underwent screening with the tone-emitting otoscope, questionnaire, and combined testing, 18.6%, 59.2%, and 63.6%, respectively, screened positive for hearing loss (P<.01 for test of equality across three arms). Patients proceeded to formal audiology evaluation 14.7%, 23.0%, and 26.6% of the time in the same screening arms, compared with 10.8% in the control arm (P<.01 for test of equality across four arms). Hearing aid use 1 year after screening was 6.3%, 4.1%, and 7.4% in the same arms, compared with 3.3% in the control arm (P<.01). Hearing aid users experienced significant improvements in hearing-related function and communication ability. CONCLUSION: In older veterans, screening for hearing loss led to significantly more hearing aid use. Screening with the tone-emitting otoscope was more efficient. The results are most applicable to older populations with few cost barriers to hearing aids. [source] Reducing Suicidal Ideation in Depressed Older Primary Care PatientsJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 10 2006Jürgen Unützer MD OBJECTIVES: To determine the effect of a primary care,based collaborative care program for depression on suicidal ideation in older adults. DESIGN: Randomized, controlled trial. SETTING: Eighteen diverse primary care clinics. PARTICIPANTS: One thousand eight hundred one adults aged 60 and older with major depression or dysthymia. INTERVENTION: Participants randomized to collaborative care had access to a depression care manager who supported antidepressant medication management prescribed by their primary care physician and offered a course of Problem Solving Treatment in Primary Care for 12 months. Participants in the control arm received care as usual. MEASUREMENTS: Participants had independent assessments of depression and suicidal ideation at baseline and 3, 6, 12, 18, and 24 months. Depression was assessed using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (SCID). Suicidal ideation was determined using the SCID and the Hopkins Symptoms Checklist. RESULTS: At baseline, 139 (15.3%) intervention subjects and 119 (13.3%) controls reported thoughts of suicide. Intervention subjects had significantly lower rates of suicidal ideation than controls at 6 months (7.5% vs 12.1%) and 12 months (9.8% vs 15.5%) and even after intervention resources were no longer available at 18 months (8.0% vs 13.3%) and 24 months (10.1% vs 13.9%). There were no completed suicides in either group. Information on suicide attempts or hospitalization for suicidal ideation was not available. CONCLUSION: Primary care,based collaborative care programs for depression represent one strategy to reduce suicidal ideation and potentially the risk of suicide in older primary care patients. [source] Remote Monitoring of Implantable Cardioverter Defibrillators versus Quarterly Device Interrogations in Clinic: Results from a Randomized Pilot Clinical TrialJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 5 2010M.H.S., SANA M. AL-KHATIB M.D. ICD: Remote Monitoring Versus Clinic Interrogations.,Introduction: Remote monitoring is increasingly becoming the new standard of care for implantable cardioverter defibrillator (ICD) follow-up. We sought to determine whether remote monitoring of ICDs improves patient outcomes compared with quarterly device interrogations in clinic. Methods and Results: In this single-center pilot clinical trial, adult patients with an ICD were randomly assigned to remote monitoring versus quarterly device interrogations in clinic. The primary endpoint was a composite of cardiovascular hospitalization, emergency room visit for a cardiac cause, and unscheduled visit to the electrophysiology clinic for a device-related issue at 1 year. We also examined health-related quality of life, costs, and patient satisfaction with their ICD care. Of 151 patients enrolled in this trial, 76 were randomized to remote monitoring and 75 to quarterly device interrogations in clinic. There was no significant difference in the primary endpoint (32% in the remote monitoring arm vs 34% in the control arm; P = 0.8), mortality, or cost between the 2 arms. Quality of life and patient satisfaction were significantly better in the control arm than in the remote monitoring arm at 6 months (83 [25th, 75th percentiles 70, 90] vs 75 [50, 85]; P = 0.002 and 88 [75, 100] vs 75 [75, 88]; P = 0.03, respectively), but not at 12 months. Conclusion: We showed no significant reduction in cardiac-related resource utilization with remote monitoring of ICDs. However, given the small number of patients in our study, the real clinical and health economics impact of remote monitoring needs to be verified by a large, multicenter, randomized clinical trial. (J Cardiovasc Electrophysiol, Vol. 21, pp. 545-550, May 2010) [source] The effectiveness and reliability of peer-marking in first-year medical studentsMEDICAL EDUCATION, Issue 10 2006Rachel English Background, Peer-marking has been suggested as a method to enhance self-directed learning and reflection, although whether this improves performance is unclear. This study evaluated the impact of peer-marking on examination performance and investigated its reliability and acceptability to students. Methods, First-year medical students were randomised to peer-marking using a model answer or no intervention (control arm). Student scores were compared with tutor-marked scores. Two months later, students completed a summative assessment and performance was compared between students randomised to peer-marking and the control arm. A focus group was held with students in the intervention arm to capture their experiences and attitudes. Results, A total of 289 of 568 students consented to participate and 147 were randomised to peer-marking (142 controls). Students randomised to peer-marking achieved marginally higher examination marks (1.5% difference, 95% CI ,0.8% to 3.9%, P = 0.19) than controls (adjusting for year and in-course assessment), although this may have been due to chance. Students were harsher markers than the tutors. Focus group analysis suggested that students valued peer-marking, although concerns about passing judgement on a colleague's work were expressed. Conclusions, Peer-marking did not have a substantial effect on examination performance, although a modest effect cannot be excluded. Students gained insight into examination technique but may not have gained deeper knowledge. Given its potential positive educational value, further work is required to understand how peer-marking can be used more effectively to enhance the learning experience. [source] Can rational prescribing be improved by an outcome-based educational approach?THE JOURNAL OF CONTINUING EDUCATION IN THE HEALTH PROFESSIONS, Issue 1 2010A randomized trial completed in Iran Abstract Introduction: An outcome-based education approach has been proposed to develop more effective continuing medical education (CME) programs. We have used this approach in developing an outcome-based educational intervention for general physicians working in primary care (GPs) and evaluated its effectiveness compared with a concurrent CME program in the field of rational prescribing. Methods: A cluster randomized controlled design was used. All 159 GPs working in 6 cities, in 2 regions in East Azerbaijan province in Iran, were invited to participate. The cities were matched and randomly divided into an intervention arm, for an outcome-based education on rational prescribing, and a control arm for a traditional CME program on the same topic. GPs' prescribing behavior was assessed 9 months before, and 3 months after the CME programs. Results: In total, 112 GPs participated. The GPs in the intervention arm significantly reduced the total number of prescribed drugs and the number of injections per prescription. The GPs in the intervention arm also increased their compliance with specific requirements for a correct prescription, such as explanation of specific time and manner of intake and precautions necessary when using drugs, with significant intervention effects of 13, 36, and 42 percentage units, respectively. Compared with the control arm, there was no significant improvement when prescribing antibiotics and anti-inflammatory agents. Discussion: Rational prescribing improved in some of the important outcome-based indicators, but several indicators were still suboptimal. The introduction of an outcome-based approach in CME seems promising when creating programs to improve GPs' prescribing behavior. [source] Intra-arterial Effects of Cisplatin on Microvascular Anastomoses in the Rat ModelTHE LARYNGOSCOPE, Issue 8 2002Deepak Gurushanthaiah MD Abstract Objective To evaluate the patency of microvascular anastomoses in arteries exposed to intra-arterial cisplatin. Study Design Animal model. Methods The common iliac artery of 15 rats was injected with 150 mg/m2 cisplatin. Five rats were injected with the same volume of saline serving as physiological controls. The ipsilateral femoral artery was transected and anastomosed using microsurgical technique within 3 to 5 days. A Doppler probe was used before and after the anastomosis to assess blood flow. The vessel was re-examined on postoperative day 5. Pulsatile blood flow and the presence or absence of a Doppler signal was recorded at this time. Vessels were harvested to include the anastomosis site and fixed for histological evaluation. The contralateral femoral artery was also harvested for comparison. Results All femoral artery anastomoses in the experimental and control arm had good, pulsatile blood flow by microscopic evaluation. No thrombosed vessels were visualized, and Doppler signals remained strong at all vessel anastomoses. Histological analysis of the vessels revealed a trend toward increased inflammatory infiltrate in the walls of the vessels treated with cisplatin. We did not appreciate a functional decrease in lumen size. Conclusions Selective catheterization intra-arterial cisplatin chemotherapy does not affect the patency of vessels following a microvascular anastomosis in the rat model. The trend toward increased inflammatory response in the vessel walls may suggest the need for closer monitoring in patients treated with intra-arterial chemotherapy. [source] Screening programmes for the early detection and prevention of oral cancerAUSTRALIAN DENTAL JOURNAL, Issue 2 2009O Kujan Background:, Screening programmes for major cancers, such as breast and cervical cancer have effectively decreased the mortality rate and helped to reduce the incidence of these cancers. Although oral cancer is a global health problem with increasing incidence and mortality rates, no national population-based screening programmes for oral cancer have been implemented. To date there is debate on whether to employ screening methods for oral cancer in the daily routine work of health providers. Objectives:, To assess the effectiveness of current screening methods in decreasing oral cancer mortality. Search strategy:, Electronic databases (MEDLINE, CANCERLIT, EMBASE (1966 to July 2005) and CENTRAL (The Cochrane Library 2005, Issue 3), bibliographies, handsearching of specific journals and contact authors were used to identify published and unpublished data. Selection criteria:, Randomized controlled trials of screening for oral cancer or precursor oral lesions using visual examination, toluidine blue, fluorescence imaging or brush biopsy. Data collection and analysis:, The search found 112 citations and these have been reviewed. One randomized controlled trial of screening strategies for oral cancer was identified as meeting the review's inclusion criteria. Validity assessment, data extraction and statistics evaluation were undertaken by two independent review authors. Main results:, One 10-year randomized controlled trial has been included (n = 13 clusters: 191 873 participants). There was no difference in the age-standardized oral cancer mortality rates for the screened group (16.4/100 000 person-years) and the control group (20.7/100 000 person-years). Interestingly, a significant 34% reduction in mortality was recorded in high-risk subjects between the intervention cohort (29.9/100 000 person-years) and the control arm (45.4/100 000). However, this study has some methodological weaknesses. Additionally, the study did not provide any information related to costs, quality of life or even harms of screening from false-positive or false-negative findings. Authors' conclusions:, Given the limitation of evidence (only one included randomized controlled trial) and the potential methodological weakness of the included study, it is valid to say that there is insufficient evidence to support or refute the use of a visual examination as a method of screening for oral cancer using a visual examination in the general population. Furthermore, no robust evidence exists to suggest that other methods of screening, toluidine blue, fluorescence imaging or brush biopsy, are either beneficial or harmful. Future high quality studies to assess the efficacy, effectiveness and costs of screening are required for the best use of public health resources. In addition, studies to elucidate the natural history of oral cancer, prevention methods and the effectiveness of opportunistic screening in high risk groups are needed. Future studies on improved treatment modalities for oral cancer and precancer are also required. Plain language summary:, Screening programmes for the early detection and prevention of oral cancer. More evidence needed to find out whether screening programmes could detect oral cancer earlier and reduce the number of deaths from this disease. Cancer of the mouth and back of the throat (oral cancer) has a low survival rate, largely because the disease is often not diagnosed until it is advanced. Screening the general population for oral cancer might make it possible to detect cases of the disease earlier. The most common method is visual inspection by a clinician, but other techniques include the use of a special blue "dye" and an imaging technique. The review found that there is not enough evidence to decide whether screening by visual inspection reduces the death rate for oral cancer, and no evidence for other screening methods. [source] A New Nonparametric Approach for Baseline Covariate Adjustment for Two-Group Comparative StudiesBIOMETRICS, Issue 4 2008Alexander Schacht Summary We consider two-armed clinical trials in which the response and/or the covariates are observed on either a binary, ordinal, or continuous scale. A new general nonparametric (NP) approach for covariate adjustment is presented using the notion of a relative effect to describe treatment effects. The relative effect is defined by the probability of observing a higher response in the experimental than in the control arm. The notion is invariant under monotone transformations of the data and is therefore especially suitable for ordinal data. For a normal or binary distributed response the relative effect is the transformed effect size or the difference of response probability, respectively. An unbiased and consistent NP estimator for the relative effect is presented. Further, we suggest a NP procedure for correcting the relative effect for covariate imbalance and random covariate imbalance, yielding a consistent estimator for the adjusted relative effect. Asymptotic theory has been developed to derive test statistics and confidence intervals. The test statistic is based on the joint behavior of the estimated relative effect for the response and the covariates. It is shown that the test statistic can be used to evaluate the treatment effect in the presence of (random) covariate imbalance. Approximations for small sample sizes are considered as well. The sampling behavior of the estimator of the adjusted relative effect is examined. We also compare the probability of a type I error and the power of our approach to standard covariate adjustment methods by means of a simulation study. Finally, our approach is illustrated on three studies involving ordinal responses and covariates. [source] Decrease of urinary nerve growth factor levels after antimuscarinic therapy in patients with overactive bladderBJU INTERNATIONAL, Issue 12 2009Hsin-Tzu Liu OBJECTIVE To determine urinary nerve growth factor (NGF) levels in patients with overactive bladder (OAB) and after treatment with antimuscarinics. PATIENTS AND METHODS Urinary NGF levels were measured in 38 ,normal' controls and 70 patients with OAB. Patients were treated with tolterodine 4 mg once daily. Urinary NGF levels were measured by enzyme-linked immunosorbent assay method and normalized by urinary creatinine levels (NGF/Cr). The urinary NGF/Cr levels and urgency severity scale (USS) were compared at baseline, 1, 2 and 3 months after antimuscarinics, and 1 month after discontinuing treatment. RESULTS The urinary NGF/Cr level was very low in normal controls with a mean (sem) of 0.005 (0.003). Patients with OAB had significantly higher baseline urinary NGF/Cr levels than the controls. Urinary NGF/Cr levels were significantly reduced at 3 months in 50 responders (1.10 [0.26] before vs 0.41 [0.09] after, P = 0.008) but not in the 20 non-responders (1.38 [0.54] before vs 1.30 [0.46] after, P = 0.879). However, after discontinuing antimuscarinic treatment for 1 month, the urinary NGF/Cr level was elevated in 23 responders at 0.83 (0.33) and in five non-responders at 2.72 (1.41). The USS scores significantly changed with the change of urinary NGF/Cr levels in responders at different time points. The voided volume increased but maximum urinary flow rate and postvoid residual volume did not increase in responders after 3-months of antimuscarinic treatment. The limitation of this study was the lack of a control arm for comparison. CONCLUSIONS Changes in the urinary NGF levels were associated with the changes of the USS scores after antimuscarinic treatment and discontinued medication. The urinary NGF level could be a potential biomarker for evaluating therapeutic results of antimuscarinics therapy. [source] Systemic therapy for advancing or metastatic prostate cancer (STAMPEDE): a multi-arm, multistage randomized controlled trialBJU INTERNATIONAL, Issue 4 2009Nicholas D. James There is a need to improve the outcomes for men with high-risk localised, nodal or metastatic prostate cancer, or with aggressively relapsing disease after initial therapy for local disease. This group of men is currently managed with long-term hormone therapy. Thus we aim to evaluate the toxicity and efficacy of three different systemic therapies (docetaxel, zoledronic acid and celecoxib) used alone or combined at the initiation of hormone manipulation for high-risk prostate cancer. A novel statistical design (multi-arm, multistage method) simultaneously tests multiple distinct strategies in parallel against a single control arm. The trial has several ,stages', from initial confirmation of safety to a phase III assessment of survival, with a series of intervening activity stages. This method provides a means of assessing several agents more quickly and efficiently, and allows inactive treatments to be dropped from further study at an early stage. STAMPEDE has been designed to address in parallel the activity and efficacy of these agents for this patient group. It is a flagship randomized clinical trial for academic research into prostate cancer in the UK. More than 500 patients have been recruited on schedule, confirming the acceptability of this complex trial design to patients and clinicians. The trial targets a population of ,3000 patients. STAMPEDE is a major new trial with a novel design applicable to the synchronous testing of several agents. It is hoped that the results will improve outcomes for patients with high-risk prostate cancer. The design could be applicable to the study of new therapies in other cancer types. Continued efforts are required by the urological cancer community to maintain the excellent recruitment shown to date. [source] Effect of homeopathy on analgesic intake following knee ligament reconstruction: a phase III monocentre randomized placebo controlled studyBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 2 2008A. Paris What is already known about this subject ,,The efficacy of homeopathy is still under debate and a recent meta-analysis recommended further randomized double-blind clinical trials to identify any clinical situation in which homeopathy might be effective. What this study adds ,,The complex of homeopathy tested in this study (Arnica montana 5 CH, Bryonia alba 5 CH, Hypericum perforatum 5 CH and Ruta graveolens 3 DH) is not superior to placebo in reducing 24 h morphine consumption after knee ligament reconstruction. Aims The efficacy of homeopathy is still under debate. The objective of this study was to assess the efficacy of homeopathic treatment (Arnica montana 5 CH, Bryonia alba 5 CH, Hypericum perforatum 5 CH and Ruta graveolens 3 DH) on cumulated morphine intake delivered by PCA over 24 h after knee ligament reconstruction. Methods This was an add-on randomized controlled study with three parallel groups: a double-blind homeopathic or placebo arm and an open-label noninterventional control arm. Eligible patients were 18,60 years old candidates for surgery of the anterior cruciate ligament. Treatment was administered the evening before surgery and continued for 3 days. The primary end-point was cumulated morphine intake delivered by PCA during the first 24 h inferior or superior/equal to 10 mg day,1. Results One hundred and fifty-eight patients were randomized (66 in the placebo arm, 67 in the homeopathic arm and 25 in the noninterventional group). There was no difference between the treated and the placebo group for primary end-point (mean (95% CI) 48% (35.8, 56.3), and 56% (43.7, 68.3), required less than 10 mg day,1 of morphine in each group, respectively). The homeopathy treatment had no effect on morphine intake between 24 and 72 h or on the visual analogue pain scale, or on quality of life assessed by the SF-36 questionnaire. In addition, these parameters were not different in patients enrolled in the open-label noninterventional control arm. Conclusions The complex of homeopathy tested in this study was not superior to placebo in reducing 24 h morphine consumption after knee ligament reconstruction. [source] The impact of prognosis without treatment on doctors' and patients' resource allocation decisions and its relevance to new drug recommendation processesBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 2 2008D. Ross Camidge What is already known about this subject ,,The dominant health economic units upon which new treatment funding decisions are made are the incremental cost per life year gained (LYG) or the cost per quality-adjusted life year (QALY) gained. ,,Neither of these units modifies the amount of health gained, by the amount of health patients would have had if they had not been given the treatment under consideration, which may unfairly undervalue the treatments for poor prognosis conditions. ,,How certain patients make decisions about their own treatment has previously been explored, but not how they, or doctors, would allocate hypothetical resource within a healthcare system given information on disease-treatment scenarios' prognoses with and without treatment. What this study adds ,,Information on prognosis without treatment is used within the resource allocation strategies of many doctors and most patients. ,,Individuals use this information in a variety of different ways and a single dominant strategy for quantitative modification of health units is not apparent. ,,Information on prognosis without treatment, or prognosis with standard treatment, is available from the control arm of randomized controlled clinical trials and should be used qualitatively to facilitate decision-making around the second inflexion point on cost per QALY/LYG acceptability curves. Aims Health economic assessments increasingly contribute to funding decisions on new treatments. Treatments for many poor prognosis conditions perform badly in such assessments because of high costs and modest effects on survival. We aimed to determine whether underlying shortness of prognosis should also be considered as a modifier in such assessments. Methods Two hundred and eighty-three doctors and 201 oncology patients were asked to allocate treatment resource between hypothetical patients with unspecified life-shortening diseases. The prognoses with and without treatment were varied such that consistent use of one of four potential allocation strategies could be deduced: life years gained (LYGs) , which did not incorporate prognosis without treatment information; percentage increase in life years (PILY); life expectancy with treatment (LEWT) or immediate risk of death (IRD). Results Random choices were rare; 47% and 64% of doctors and patients, respectively, used prognosis without treatment in their strategies; while 50% and 32%, respectively, used pure LYG-based strategies. Ranking orders were LYG > PILY > IRD > LEWT (doctors) and LEWT > LYG > IRD > PILY (patients). When LYG information alone could not be used, 76% of doctors prioritized shorter prognoses, compared with 45% of patients. Conclusions Information on prognosis without treatment is used within the resource allocation strategies of many doctors and most patients, and should be considered as a qualitative modifier during the health economic assessments of new treatments for life-shortening diseases. A single dominant strategy incorporating this information for any quantitative modification of health units is not apparent. [source] The impact of psoriasis guidelines on appropriateness of referral from primary to secondary care: a randomized controlled trialBRITISH JOURNAL OF DERMATOLOGY, Issue 2 2006C.E.M. Griffiths Summary Background, Most patients with psoriasis have limited disease which can be managed effectively in primary care. There is a marked variation in the frequency of referrals between practices reflecting, in part, inadequate training of general practitioners (GPs) in the management of psoriasis. Objectives, To assess the effectiveness of guidelines and training sessions on the management of psoriasis in reducing inappropriate referrals from primary care. Methods, Patients aged 18 years or over with psoriasis were eligible for the cluster-randomized, randomized controlled trial if they were referred by their GP between 9 September 2002 and 31 December 2003 to one of four hospital dermatology departments in Greater Manchester, North-West England. All GPs from 165 health centres were invited to a lecture by a local dermatologist on the diagnosis and management of psoriasis. Health centres in the intervention arm received guidelines on the management of psoriasis in primary care, developed by local dermatologists, supplemented by the offer of a practice-based nurse-led training session; those in the control arm received neither guidelines nor training sessions. Results, Eighty-two health centres were randomized to the intervention arm and 83 to the control arm. Outcome data were available for 188 of the 196 eligible patients referred during the study period. Patients in the intervention arm were significantly more likely to be appropriately referred in comparison with patients in the control arm [difference = 19·1%; odds ratio (OR) 2·47; 95% confidence interval (CI) 1·31,4·68; intracluster correlation coefficient (ICC) = 0]. Only 25 (30%) health centres in the intervention arm took up the offer of training sessions. There was no significant difference in outcome between health centres in the intervention arm that received a training session and those that did not (OR 1·28, 95% CI 0·50,3·29, ICC = 0). Conclusions, Dissemination of guidelines on the management of psoriasis in primary care can significantly enhance the appropriateness of referral of patients to secondary care. [source] Use of tamoxifen in advanced-stage hepatocellular carcinoma,CANCER, Issue 7 2005A systematic review Abstract BACKGROUND Hepatocellular carcinoma (HCC) is the third most common cause of cancer mortality worldwide. Survival is poor for patients with advanced-stage HCC, and small trials of tamoxifen for patients with this disease have shown conflicting results. The authors conducted a systematic review of randomized clinical trials to compare the effect of a tamoxifen-containing arm with a nontamoxifen-containing arm in advanced HCC. METHODS Eligible trials were identified from the Cochrane Hepato-Biliary Group register and other databases. Studies were selected for inclusion and their methodologic quality assessed by three independent reviewers. Hazard ratios (HR) were derived for overall survival where possible. Metaanalysis was performed using a fixed-effect model. RESULTS The authors identified 10 randomized trials with a total of 1709 patients. Use of tamoxifen had no effect on median survival (HR, 1.05; 95% confidence interval, 0.94,1.16; P = 0.4) or tumor response rate. The findings were stable in sensitivity analyses and were not affected by publication bias or inclusion of low-quality studies or studies reported in abstract form only. Few adverse events or withdrawals were noted. CONCLUSIONS There was no support for the therapeutic use of tamoxifen in advanced HCC, nor for its use as a control arm in future clinical trials. Cancer 2005. © 2005 American Cancer Society. [source] SURGICAL SITE MARKING DOES NOT AFFECT STERILITYANZ JOURNAL OF SURGERY, Issue 8 2008John Rooney Background: In 2005, surgical site marking became mandatory in Australia, with the introduction of the first Australian guidelines to prevent wrong site surgery. It has been our experience that most surgical site marking occurs with the use of a non-sterile marking pen, which has been used on multiple patients and there is little information in the published work about the effects of surgical site marking carried out in this fashion. Our aim was to determine whether the sterility of a surgical site was affected by surgical site marking with a non-sterile surgical marking pen. Methods: Both forearms of 20 volunteers would simulate surgical sites. Surgical site marking was carried out on right forearms with the same non-sterile surgical marking pen, whereas left forearms were unmarked controls. Microbiology swabs were taken from both forearms before, and after, skin sterilization with 10% povidone,iodine. Routine cultures were carried out on the swabs after sodium thiosulphate was used to deactivate residual iodine. Cultures were assessed for growth after 5 days. Results: One of the 20 marked forearms and 15 of the 20 unmarked forearms had bacterial growth on cultures before skin sterilization (P < 0.1). After sterilization with iodine, no bacterial growth occurred in the cultures of the swabs taken from the marked or control arms. Conclusion: Surgical site marking carried out with a non-sterile surgical marking pen did not contaminate the surgical site. We recommend the practice of surgical site marking. [source] Tea tree oil reduces histamine-induced skin inflammationBRITISH JOURNAL OF DERMATOLOGY, Issue 6 2002K.J. Koh Summary Background Tea tree oil is the essential oil steam-distilled from Melaleuca alternifolia , an Australian native plant. In recent years it has become increasingly popular as an antimicrobial for the treatment of conditions such as tinea pedis and acne. Objectives ,To investigate the anti-inflammatory properties of tea tree oil on histamine-induced weal and flare. Methods Twenty-seven volunteers were injected intradermally in each forearm (study and control assigned on an alternating basis) with histamine diphosphate (5 µg in 50 µL). Flare and weal diameters and double skin thickness were measured every 10 min for 1 h to calculate flare area and weal volume. At 20 min, 25 µL of 100% tea tree oil was applied topically to the study forearm of 21 volunteers. For six volunteers, 25 µL paraffin oil was applied instead of tea tree oil. Results Application of liquid paraffin had no significant effect on histamine-induced weal and flare. There was also no difference in mean flare area between control arms and those on which tea tree oil was applied. However, mean weal volume significantly decreased after tea tree oil application (10 min after tea tree oil application, P = 0·0004, Mann,Whitney U-test). Conclusions ,This is the first study to show experimentally that tea tree oil can reduce histamine-induced skin inflammation. [source] Overview of the 2006 Food and Drug Administration Circulatory System Devices Panel meeting on drug-eluting stent thrombosisCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 2007Tina L. Pinto Slottow Abstract Drug-eluting stents (DES) seemed likely to mitigate the problem of restenosis and have become the predominant stent deployed during percutaneous coronary intervention (PCI). Sustained concerns about the rate of stent thrombosis (ST), particularly very late ST (>1 year following PCI) led to a meeting of the Circulatory System Devices Advisory Panel to address "on-label" and "off-label" use as well as appropriate duration of dual antiplatelet therapy following DES. Over 40 presentations by members of the FDA, industry personnel, and leaders in the field of interventional cardiology helped set forth the body of data available on DES. Standardized definitions of ST created by the Academic Research Consortium were applied to existing randomized trials and registries. At the end of the 2-day session, the consensus of the panel was that "on-label" DES use is not associated with increased incidence of death and myocardial infarction (MI), although it is associated with increased rates of very late ST. "Off-label" use is associated with increased risk of death or MI when compared with "on-label" use. Insufficient data exist to determine the duration of clopidogrel that would minimize ST and bleeding risk, but the panel agreed with the current ACC/AHA/SCAI guidelines regarding dual antiplatelet therapy for at least 12 months in patients at low risk for bleeding, especially with "off-label" use. More data from trials designed with better control arms and prespecified analyses of complex patients and lesions subsets over longer periods of follow-up are needed. © 2007 Wiley-Liss, Inc. [source] | ||||||||||||||||||||||