3 resultados para controlled clinical trial

em CORA - Cork Open Research Archive - University College Cork - Ireland


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Objectives: to assess elderly patients’ dental status and dental habits and compare the survival rates, impact on patients’ quality of life and cost-effectiveness of Atraumatic Restorative Treatment (ART) and a conventional treatment (CT) to restore carious lesions in an elderly population. Methods: In this randomised clinical trial, 99 independently living adults (65-90 yrs) with carious lesions were randomly allocated to receive either ART or CT. Details of restored, missing and carious teeth were recorded and patients answered some questions about their oral hygiene and dental attendance habits. Direct and indirect costs were measured based on treatment time, materials and labour. Effectiveness was measured using restoration survival percentage after one year. The survival of restorations was assessed 6 months and one year after restoration placement by an independent examiner. Oralhealth related quality of life (OHRQoL) was assessed using the OHIP-14 at baseline and 2 months after treatment together with a global transition statement. Results: The patient sample comprised 46 (46.46%) male and 53 (53.54) female participants at baseline, with a mean age of 73.18 (SD=6.76). The mean DMFT of the entire sample was 27.10. Ninety patients and 268 restorations could be assessed after one year, 127 ART (46 patients) and 141 conventional restorations (44 patients). 93.7% and 97.2% of the restorations placed were considered successful in the ART and CT groups, respectively. The OHIP scores did not change dramatically 2 months after treatment, in either group. The global transition scale showed an improvement in overall oral health after treatment for the majority of patients. The ART were more cost-effective compared to the CT restorations. Conclusions: ART presented survival rates similar to CT after 1 year and was a more cost-effective alternative to treat the elderly.

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Background: Thyroid drains following thyroid surgery are routinely used despite minimal supportive evidence. Our aim in this study is to determine the impact of routine open drainage of the thyroid bed postoperatively on ultrasound-determined fluid accumulation at 24 hours. Methods: We conducted a prospective randomised clinical trial on patients undergoing thyroid surgery. Patients were randomly assigned to a drain group (n = 49) or a no-drain group (n = 44) immediately prior to wound closure. Patients underwent a neck ultrasound on day 1 and day 2 postoperatively. After surgery, we evaluated visual analogue scale pain scores, postoperative analgesic requirements, self-reported scar satisfaction at 6 weeks and complications. Results: There was significantly less mean fluid accumulated in the drain group on both day 1, 16.4 versus 25.1 ml (P-value = 0.005), and day 2, 18.4 versus 25.7 ml (P-value = 0.026), following surgery. We found no significant differences between the groups with regard to length of stay, scar satisfaction, visual analogue scale pain score and analgesic requirements. There were four versus one wound infections in the drain versus no-drain groups. This finding was not statistically significant (P = 0.154). No life-threatening bleeds occurred in either group. Conclusions: Fluid accumulation after thyroid surgery was significantly lessened by drainage. However, this study did not show any clinical benefit associated with this finding in the non-emergent setting. Drains themselves showed a trend indicating that they may augment infection rates. The results of this study suggest that the frequency of acute life-threatening bleeds remains extremely low following abandoning drains. We advocate abandoning routine use of thyroid drains. Trial registration: ISRCTN94715414.

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Background: Self-management education may help patients with cystic fibrosis and their families to choose, monitor and adjust treatment requirements for their illness, and also to manage the effects of illness on their lives. Although self-management education interventions have been developed for cystic fibrosis, no previous systematic review of the evidence of effectiveness of these interventions has been conducted. Objectives: To assess the effects of self-management education interventions on improving health outcomes for patients with cystic fibrosis and their caregivers. Search methods: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register (date of the last search: 22 August 2013). We also searched databases through EBSCO (CINAHL; Psychological and Behavioural Sciences Collection; PsychInfo; SocINDEX) and Elsevier (Embase) and handsearched relevant journals and conference proceedings (date of the last searches: 01 February 2014 ). Selection criteria: Randomised controlled trials, quasi-randomised controlled trials or controlled clinical trials comparing different types of self-management education for cystic fibrosis or comparing self-management education with standard care or no intervention. Data collection and analysis: Two authors assessed trial eligibility and risk of bias. Three authors extracted data. Main results: Four trials (involving a total of 269 participants) were included. The participants were children with cystic fibrosis and their parents or caregivers in three trials and adults with cystic fibrosis in one trial. The trials compared four different self-management education interventions versus standard treatment: (1) a training programme for managing cystic fibrosis in general; (2) education specific to aerosol and airway clearance treatments; (3) disease-specific nutrition education; and (4) general and disease-specific nutrition education. Training children to manage cystic fibrosis in general had no statistically significant effects on weight after six to eight weeks, mean difference -7.74 lb (i.e. 3.51 kg) (95% confidence interval -35.18 to 19.70). General and disease-specific nutrition education for adults had no statistically significant effects on: pulmonary function (forced expiratory volume at one second), mean difference -5.00 % (95% confidence interval -18.10 to 8.10) at six months and mean difference -5.50 % (95% confidence interval -18.46 to 7.46) at 12 months; or weight, mean difference - 0.70 kg (95% confidence interval -6.58 to 5.18) at six months and mean difference -0.70 kg (95% confidence interval -6.62 to 5.22) at 12 months; or dietary fat intake scores, mean difference 1.60 (85% confidence interval -2.90 to 6.10) at six months and mean difference 0.20 (95% confidence interval -4.08 to 4.48) at 12 months. There is some limited evidence to suggest that self-management education may improve knowledge in patients with cystic fibrosis but not in parents or caregivers. There is also some limited evidence to suggest that self-management education may result in positively changing a small number of behaviours in both patients and caregivers. Authors' conclusions: The available evidence from this review is of insufficient quantity and quality to draw any firm conclusions about the effects of self-management education for cystic fibrosis. Further trials are needed to investigate the effects of self-management education on a range of clinical and behavioural outcomes in children, adolescents and adults with cystic fibrosis and their caregivers.