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Rigorous Methodology (rigorous + methodology)
Selected AbstractsForming a national multicentre collaboration to conduct clinical trials: Increasing high-quality research in the drug and alcohol fieldDRUG AND ALCOHOL REVIEW, Issue 5 2010ROB SANSON-FISHER Abstract Issues. There is a shortage of high-quality intervention-based evidence in the drug and alcohol misuse field. That is, evidence based on replicated effects using rigorous methodology, to establish a causal knowledge base around ethical, cost-effective methods relevant to clinical practice. The knowledge base in this field is limited participant recruitment challenges; difficulty generalising results from single-centre studies; lack of research culture; issues in managing research teams; incentives for descriptive research; and limited expertise in research design and working in multidisciplinary teams. Approach. An Australian national multicentre collaboration is proposed to overcome these barriers, and reduce the burden of drug and alcohol misuse by increasing the number of high-quality clinical trials in this field. It would involve: selecting a representative sample of centres nation-wide with expertise in specific drug and alcohol issues; creating an expert multidisciplinary team to facilitate clinical trials; simultaneous recruitment and implementation of clinical trials across centres; establishing a virtual infrastructure; forming an independent data-integrity and methodology review panel; and attracting and allocating funding for clinical trials. Implications. The ability to allocate funding, the involvement of multidisciplinary experts in drug and alcohol research, and the establishment of infrastructure and procedures are likely to result in the national multicentre group's capacity to prescribe the type of research conducted under its auspices. Conclusion. The proposed initiative is likely to increase the volume of high-quality clinical trials in the Australian drug and alcohol field, a key step towards reducing the burden of drug and alcohol misuse.[Sanson-Fisher R, Brand M, Shakeshaft A, Haber P, Day C, Conigrave K, Mattick R, Lintzeris N, Teesson M. Forming a national multicentre collaboration to conduct clinical trials: Increasing high-quality research in the drug and alcohol field. Drug Alcohol Rev 2010;29;469,474] [source] Real Time Three-Dimensional Echocardiography Evaluation of Mitral Annular Characteristics in Patients with Myocardial HypertrophyECHOCARDIOGRAPHY, Issue 4 2008Fatih Yalçin M.D. It has been shown that systolic excursion of the mitral annulus (MA) correlates well with left ventricular (LV) systolic function. Evaluation of the complicated shape and dynamics of the mitral annulus, however, may require rigorous methodology. The aim of this study was to investigate differences in MA motion between hypertrophic cardiomyopathy (HCM) and left ventricular hypertrophy (LVH) patients due to hypertension or aortic stenosis using real time three-dimensional echocardiography (RT3DE). We studied 10 HCM, 10 LVH, and 10 controls. Mean MA area changes between early and late systole were 9.5 ± 4.3% in HCM, 26 ± 15% in LVH and 19 ± 10% in normal controls. MA apicobasal motion was 5.8 ± 4 mm in HCM, 11 ± 4 mm in LVH, and 13.6 ± 6 mm in normal controls. RT3DE with digital reconstruction of MA accurately display complicated MA geometry and dynamics during a cardiac cycle. Annular function in LVH was similar to that of the normal group while annular apicobasal motion and area changes were reduced in HCM. [source] Effects of rapid smoking on post-cessation urges to smokeADDICTION, Issue 3 2007Hayden McRobbie ABSTRACT Context Rapid smoking (RS) is a smoking cessation technique with sufficient indications of promise to warrant further investigation. The main presumed effect of RS is on reducing desire to smoke. Aim To evaluate the effect of a single session of RS immediately prior to quitting smoking on urges to smoke over the first week of abstinence. Design Randomized controlled trial. Setting Specialist smoking cessation clinic (SSCC). Participants A total of 100 smokers attending the quit day session. Intervention Participants in the rapid smoking group underwent a single session of RS immediately prior to quitting smoking. Participants in the control group watched a health promotion video on giving up smoking. Primary outcome measures Ratings of urges to smoke in the first 24 hours and 1 week of abstinence. Findings The RS procedure was well tolerated. It led to significantly lower urges to smoke compared to the control procedure during the first 24 hours (mean rating of 2.6 versus 3.2, P < 0.001) and the first week of abstinence (1.8 versus 2.5, P < 0.01). In patients abstinent for 4 weeks, urges to smoke were low and the difference was no longer significant (1.4 versus 1.8). Conclusion RS has an ,active ingredient' (craving reduction) and its effects on smoking cessation may merit further examination using modern rigorous methodology. [source] Efficacy of four insect repellents against mosquito bites: a double-blind randomized placebo-controlled field study in SenegalFUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 5 2009Bernard Uzzan Abstract Insect-borne diseases represent a worldwide threat. In addition to fight against vectors (insecticides) and disease prevention (vaccination against yellow fever, chemoprophylaxis against malaria), insect repellents applied on the skin could help reduce the heavy burden related to these diseases. In a field study performed in Senegal, we compared the efficacy of one skin application between 3 and 4 p.m. of four spray repellents [icaridine 20%, para-menthane-diol (PMD) 20% and 50% and DEET 50%] against placebo, among 100 healthy male and female volunteers experienced with mosquito capture. Double-blind randomized cross-over placebo-controlled study (Latin-square design) during five consecutive nights (7 p.m. to midnight) in two villages was conducted. To avoid residual effect, right or left leg was alternately exposed during consecutive nights and the exposed leg was washed before next night. The statistical model was random and mixed effects anova. All four active repellents provided a significant and similar protection compared with placebo, lasting 8 h. However, there was a non-significant trend for a higher protection by DEET 50% than by PMD 20% (P = 0.07). Duration of protection was similar for all repellents. Their effects were similar among men and women, and against Anopheles or other species. No serious adverse drug reaction was noticed. Using a rigorous methodology and a large number of volunteers, our well-controlled study demonstrated an important and similar protective effect of all four repellents compared with placebo. Such field studies should be required before approval of any newly developed repellent. [source] Variability in the upper limit of normal for serum alanine aminotransferase levels: A statewide study,HEPATOLOGY, Issue 6 2009Anand Dutta We conducted a study to characterize the variability in the upper limit of normal (ULN) for alanine aminotransferase (ALT) across different laboratories (labs) in Indiana and to understand factors leading to such variability. A survey was mailed to all eligible labs (n = 108) in Indiana, and the response rate was 62%. The survey queried for ALT ULN, the type of chemical analyzer used, five College of American Pathologists (CAP) sample results, and methods used to establish the reference interval. There was a wide variability in the ALT ULN for both men and women. Eighty-five percent of labs used chemical analyzers belonging to one of the four brands. For all five CAP samples, there was a statistically significant difference in ALT values measured by different analyzers (P < 0.0001), but these differences were not clinically significant. The majority of labs used the manufacturers' recommendations for establishing their ALT ULN rather than in-house healthy volunteer testing (only 17%). When healthy volunteers were tested, the process for testing was haphazard in terms of the number of individuals tested, frequency of testing, and criteria for choosing the reference population. After controlling for chemical analyzer type, there was no significant relationship between ALT ULN values and the method used for its establishment. Conclusion: Wide variability in ALT ULN across different labs is more likely due to variable reference intervals of different chemical analyzers. It may be possible to minimize variability in ALT ULN by (1) each lab solely following the manufacturers' recommendations and (2) manufacturers of different analyzers following consistent and rigorous methodology in establishing the reference range. Alternatively, studies should be undertaken to identify outcome-based reference intervals for ALT. (HEPATOLOGY 2009.) [source] A study of best practices in training transfer and proposed model of transferHUMAN RESOURCE DEVELOPMENT QUARTERLY, Issue 2 2008Lisa A. Burke Data were gathered from a sample of training professionals of an American Society of Training and Development (ASTD) chapter in the southern United States regarding best practices for supporting training transfer. Content analysis techniques, based on a rigorous methodology proposed by Insch, Moore, & Murphy (1997), were used to analyze the rich data. Findings suggest that interventions for bolstering training transfer are best carried out in the work context and design and delivery phase, take place after training or during, and involve trainers and supervisors. Activities garnering top attention from trainers as best practices include (starting with most frequently reported) supervisory support activities, coaching, opportunities to perform, interactive training activities, transfer measurement, and job-relevant training. Several new transfer variables also emerged from the data, indicating existing transfer models can be further refined. Ultimately, we propose a refined model of transfer to extend human resource development (HRD) theory in the area of transfer. [source] Height functions for applying contact angles to 3D VOF simulationsINTERNATIONAL JOURNAL FOR NUMERICAL METHODS IN FLUIDS, Issue 8 2009S. Afkhami Abstract A rigorous methodology is presented for applying a contact angle as a contact line boundary condition within a 3D volume-of-fluid-based flow algorithm, based on the recently developed height function methodology that yields accurate interface normals and curvatures from volume fractions. We demonstrate that the approach yields accurate estimates of curvature and surface tension at a contact line, values that converge with spatial refinement. We then study the efficacy of this approach via examples of both static and dynamic contact line phenomena. Copyright © 2008 John Wiley & Sons, Ltd. [source] Early versus late enteral nutritional support in adults with burn injury: a systematic reviewJOURNAL OF HUMAN NUTRITION & DIETETICS, Issue 2 2007J. Wasiak Abstract Background Burn injury increases the body's metabolic demands, and therefore nutritional requirements. Provision of an adequate supply of nutrients is believed to lower the incidence of metabolic abnormalities, thus reducing septic morbidity, and improving survival rates. Enteral nutrition support is the best feeding method in a patient who is unable to achieve an adequate oral intake, but optimal timing of its introduction after burn injury (i.e. early versus late) needs to be established. The purpose of this review is to examine evidence for the effectiveness and safety of early versus late enteral nutrition support in adults with burn injury. Methods An examination of randomized and controlled clinical trials using various medical databases such as The Cochrane Library (Issue 3, 2006), MEDLINE (from 1950), CINHAL (from 1982) and EMBASE (from 1980). Results The trial evidence about the benefit of early enteral nutritional support on standardized clinical outcomes such as length of hospital stay and mortality remained inconclusive. Similarly, the question of whether early enteral feeding influenced or decreased metabolic rate, reduced septic and other complications remained uncertain. Conclusions Promising results suggest early enteral nutrition support may blunt the hypermetabolic response to thermal injury, but it is insufficient to provide clear guidelines for practice. Further research incorporating larger sample sizes and rigorous methodology that utilizes valid and reliable outcome measures is essential. [source] | ||||||||||