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Trial Study (trial + study)
Selected AbstractsEffectiveness and Appropriateness of Therapeutic Play Intervention in Preparing Children for Surgery: A Randomized Controlled Trial StudyJOURNAL FOR SPECIALISTS IN PEDIATRIC NURSING, Issue 2 2008Ho Cheung William Li PURPOSE.,This paper aims to examine the effectiveness and appropriateness of using therapeutic play in preparing children for surgery. DESIGN/METHOD.,A randomized controlled trial was employed. Children (7,12 years of age; n = 203) admitted for surgery during a 13-month period were recruited. RESULTS.,The results support the effectiveness and appropriateness of using therapeutic play in preparing children for surgery. PRACTICE IMPLICATIONS.,The study results promote awareness in nurses and parents that play is a very important part of children's lives, and heighten the importance of integrating therapeutic play as an essential component of holistic and quality nursing care to prepare children for surgery. [source] Factors predictive of nephropathy in DCCT Type 1 diabetic patients with good or poor metabolic controlDIABETIC MEDICINE, Issue 7 2003L. Zhang Abstract Aims The study aim was to assess the time-related risk of developing diabetic nephropathy [albumin excretion rate (AER) , 40 mg/24 h] from baseline covariates in Type 1 diabetic patients with either good or poor metabolic control (MC). Methods Based on material from the Diabetes Control and Complications Trial study (n = 1441), patients were considered as under good or poor MC if their HbA1c mean level up to last visit fell in the lowest (, 6.9%) or highest (, 9.5%) quintile of the overall HbA1c distribution, respectively. Prevalence cases of nephropathy were excluded from the study. Survival analysis and Cox regression were applied to the data. Results Among patients with good MC (n = 277), 15% had developed nephropathy at the end of the study. Conversely, among patients with poor MC (n = 268), the proportion without the complication was 52%. When adjusting for MC, time to diabetic nephropathy was related to age (P < 0.0001), AER (P < 0.001), duration of diabetes (P < 0.005), body mass index (BMI) (P < 0.005), all at baseline, and to gender (P < 0.01). Patients with upper normal range AER levels, longer duration of diabetes and lower BMI were at higher risk, regardless of MC. The adverse effect of younger age on diabetic nephropathy was more marked in good than in poor MC. Although women tended to develop the complication more often under good MC, they appeared to be better protected under poor MC. Conclusions This study confirms occurrence of diabetic nephropathy under good MC and non-occurrence of the complication despite poor MC. It also demonstrates that some baseline covariates can affect, in a differential manner, time to diabetic nephropathy depending on MC. Diabet. Med. 20, 580,585 (2003) [source] Glucosamine sulphate in the treatment of knee osteoarthritis: cost-effectiveness comparison with paracetamolINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 6 2010S. Scholtissen Summary Introduction:, The aim of this study was to explore the cost-effectiveness of glucosamine sulphate (GS) compared with paracetamol and placebo (PBO) in the treatment of knee osteoarthritis. For this purpose, a 6-month time horizon and a health care perspective was used. Material and methods:, The cost and effectiveness data were derived from Western Ontario and McMaster Universities Osteoarthritis Index data of the Glucosamine Unum In Die (once-a-day) Efficacy trial study by Herrero-Beaumont et al. Clinical effectiveness was converted into utility scores to allow for the computation of cost per quality-adjusted life year (QALY) For the three treatment arms Incremental Cost-Effectiveness Ratio were calculated and statistical uncertainty was explored using a bootstrap simulation. Results:, In terms of mean utility score at baseline, 3 and 6 months, no statistically significant difference was observed between the three groups. When considering the mean utility score changes from baseline to 3 and 6 months, no difference was observed in the first case but there was a statistically significant difference from baseline to 6 months with a p-value of 0.047. When comparing GS with paracetamol, the mean baseline incremental cost-effectiveness ratio (ICER) was dominant and the mean ICER after bootstrapping was ,1376 ,/QALY indicating dominance (with 79% probability). When comparing GS with PBO, the mean baseline and after bootstrapping ICER were 3617.47 and 4285 ,/QALY, respectively. Conclusion:, The results of the present cost-effectiveness analysis suggested that GS is a highly cost-effective therapy alternative compared with paracetamol and PBO to treat patients diagnosed with primary knee OA. [source] Comparison of efficacy of azithromycin vs. doxycycline in the treatment of rosacea: a randomized open clinical trialINTERNATIONAL JOURNAL OF DERMATOLOGY, Issue 3 2008Maryam Akhyani MD Background, Rosacea is a common inflammatory disorder of the skin. Systemic antibiotics currently used in the treatment of rosacea are sometimes associated with uncomfortable side effects. Therefore, a need for an effective agent with few side effects and good patient compliance exists. Azithromycin, a macrolide antibiotic with prolonged mode of action, has recently been found to be an effective alternative in the treatment of inflammatory acne. Methods, For evaluation of the efficacy of azithromycin in the treatment of rosacea, we planned a randomized, open, clinical trial study to compare the efficacy of azithromycin with doxycycline in the treatment of this disease. Sixty-seven patients were randomized to receive either azithromycin 500 mg thrice weekly (on Monday, Wednesday, and Saturday) in the first, 250 mg thrice weekly (on Monday, Wednesday, and Saturday) in the second, and 250 mg twice weekly (on Tuesday, and Saturday) in the third month. The other group was given doxycycline 100 mg/day for the three months. Clinical assessment was made at baseline, at the end of first, second, third, and 2 months after treatment. Side affects were recorded. The limitation of this study is that there was no blindness. Results, Statistically significant improvement was obtained with both drugs. Neither drug was shown to be more effective than the other. In the azithromycin group four patients had diarrhea, while epigastric burning was seen in two patients using doxycycline. Conclusion, This study indicates that azithromycin is at least as effective as doxycycline in the treatment of rosacea. [source] Measuring physiotherapists' guideline adherence by means of clinical vignettes: a validation studyJOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 5 2006Geert M.J. Rutten MPH Abstract Rationale, aims and objectives, To assess the criterion validity of paper-and-pencil vignettes to assess guideline adherence by physiotherapists in the Netherlands. The evidence-based physiotherapy practice guideline for low back pain was used as an example. Methods, Four vignettes were constructed and pre-tested. Three vignettes were found to represent an adequate case-mix. They described one patient with specific low back pain, one with non-specific low back pain and a normal recovery process and one with non-specific low back pain and a delay in the recovery process. Invited to participate were 113 primary care physiotherapists who had joined an randomized controlled trial study 8 months before, in which guideline adherence had been measured by means of semi-structured treatment recording forms. The criterion validity was determined with Spearman's rs, using Cohen's classification for the behavioural sciences to categorize its effect size. Results, Of the 72 physiotherapists who agreed to participate, 39 completed the questions on the vignettes. In the end, both adherence measures were available for 34 participants, providing 102 vignettes and 268 recording forms. Mean guideline adherence scores were 57% (SD = 17) when measured by vignettes and 74% (SD = 15) when measured by recording forms. Spearman's rs was 0.31 (P = 0.036), which, according to Cohen's classification, is a medium effect size. Conclusion, Vignettes are of acceptable validity, and are an inexpensive and manageable instrument to measure guideline adherence among large groups of physiotherapists. Further validation studies could benefit from the use of standardized patients as a gold standard, a more diverse case mix to better reflect real physiotherapy practice, and the inclusion of longitudinal vignettes that cover the patients' course of treatment. [source] A Blind Trial Evaluation of a Crime Scene Methodology for Deducing Impact Velocity and Droplet Size from Circular Bloodstains,JOURNAL OF FORENSIC SCIENCES, Issue 1 2007Lee Hulse-Smith M.S. ABSTRACT: In a previous study, mechanical engineering models were utilized to deduce impact velocity and droplet volume of circular bloodstains by measuring stain diameter and counting spines radiating from their outer edge. A blind trial study was subsequently undertaken to evaluate the accuracy of this technique, using an applied, crime scene methodology. Calculations from bloodstains produced on paper, drywall, and wood were used to derive surface-specific equations to predict 39 unknown mock crime scene bloodstains created over a range of impact velocities (2.2,5.7 m/sec) and droplet volumes (12,45 ,L). Strong correlations were found between expected and observed results, with correlation coefficients ranging between 0.83 and 0.99. The 95% confidence limit associated with predictions of impact velocity and droplet volume was calculated for paper (0.28 m/sec, 1.7 ,L), drywall (0.37 m/sec, 1.7 ,L), and wood (0.65 m/sec, 5.2 ,L). [source] Efficacy and safety of preprandial versus postprandial administration of low-dose cyclosporin microemulsion (Neoral) in patients with psoriasis vulgarisTHE JOURNAL OF DERMATOLOGY, Issue 7 2007Hideo HASHIZUME ABSTRACT A study of therapeutic drug monitoring indicated that cyclosporin administered before meals produces higher blood concentrations than an equivalent dose administered after meals. Our objective was to compare the efficacy of cyclosporin administered before and after meals, respectively, in psoriasis vulgaris patients. We performed an open trial study. Patients were randomly assigned to receive cyclosporin before (group B, n = 20) or after meals (group A, n = 17), and were followed up in 10 dermatology clinics. The difference between groups was evaluated in severity. The percent reduction in psoriasis area and severity index score from baseline was 29.8% in group A and 75.4% in group B (A vs B, P = 0.00005). Two patients in each group withdrew due to abnormality of laboratory data. Short-term, low-dose treatment with cyclosporin before rather than after meals is suggested as a new effective treatment regimen for psoriasis, with the added advantage of lowering costs. [source] Endometrial local injury improves the pregnancy rate among recurrent implantation failure patients undergoing in vitro fertilisation/intra cytoplasmic sperm injection: A randomised clinical trialAUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 6 2009Mohammad Ali KARIMZADEH Background:, Implantation failure is the most important cause of recurrent in vitro fertilisation (IVF)/intra cytoplasmic sperm injection (ICSI) failure. It has been reported that endometrial injury using a biopsy catheter resulted in a higher pregnancy rate in following cycle of treatment. The local endometrial trauma increases the implantation rate through the release of chemical mediators such as histamine and growth factor. Aims:, To evaluate the influence of endometrial biopsy on increasing implantation rate in patients with recurrent implantation failures. Methods:, In a randomised control trial study, 115 women each with at least two implantation failures were randomly assigned to two groups. In the case group, endometrial biopsy was obtained from patients in the luteal phase of previous cycle, and implantation and clinical pregnancy rates were compared with those of patients in the control group. Results:, The implantation rate was determined as 10.9% in the biopsy group compared to 3.38% in the controls. The clinical pregnancy rate was significantly higher in the case group than in controls (27.1% and 8.9% respectively). Conclusion:, The results suggest that pregnancy outcome increases through IVF or ICSI after endometrial biopsy. [source] Double-blind randomized controlled trial study on post-extraction immediately restored implants using the switching platform concept: soft tissue response.CLINICAL ORAL IMPLANTS RESEARCH, Issue 4 2009Preliminary report Abstract Aim: To evaluate the soft tissue response to immediately placed implants using the platform switching concept. Material and methods: In 22 patients, 22 implants of 5.5 mm platform diameter were placed immediately into fresh extraction sockets in maxillae without compromised bone tissue. Eventual post-extraction bone defects were filled using bovine bone matrix mixed with collagen. Immediately after insertion, implants were randomly divided: 11 implants were connected with a 3.8 mm diameter abutment (test group) and 11 with a 5.5 mm diameter abutment (control group). A provisional crown was adapted and adjusted for non-functional immediate positioning. Two months later, definitive prosthetic rehabilitation was performed. Periodontal parameter, buccal peri-implant mucosal changes (REC), mesial and distal papilla height (PH) and vertical height of jumping distance (VHG) were measured at the time of implant placement, of definitive prosthesis insertion and every 6 months thereafter. Results: The mean follow-up was 25 months. All implants were clinically osseointegrated. The test group showed a +0.18 mm REC gain. PH gain was +0.045 mm on average. The mean values were statistically significant (P,0.005) compared with the control group (PH=,0.88 mm; REC=,0.45 mm). No difference between the two groups in periodontal parameters was found. The mean value of bone filling was 7.51 mm in the test group (97.4% of VHG) and 8.57 mm in the control group (95.2% of VHG). No statistically significant difference was found between the two groups. Conclusions: This study suggests that, in a limited time period of 2 years, immediately placed implants with subsequent platform switching can provide peri-implant tissue stability. [source] | ||||||||||