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Reichmann, William Michael. "Methods in subgroup analysis: estimation of risk and implications for randomized controlled trial design." Thesis, Boston University, 2012. https://hdl.handle.net/2144/32047.
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Thesis (Ph.D.)--Boston UniversityPLEASE NOTE: Boston University Libraries did not receive an Authorization To Manage form for this thesis or dissertation. It is therefore not openly accessible, though it may be available by request. If you are the author or principal advisor of this work and would like to request open access for it, please contact us at open-help@bu.edu. Thank you.
Estimation of exposure-specific risks (ESRs) using estimates of the overall risk and relative risk of disease given exposure has been performed in previous studies, but the performance of such an estimator has not been assessed nor has a variance for such an estimate been proposed. In this project I evaluated the performance of a simple product-based ESR and its variance derived using the delta method. I used the variance to estimate the 95% confidence interval. I found that this point estimate was biased and that the accompanying 95% confidence interval did not attain 95% coverage. I also proposed a revised product-based estimator and found that this estimator was unbiased. I used the delta method to derive a variance for this estimator and estimated the 95% confidence interval. The coverage of this interval attained 95% coverage in most situations. According to the CONSORT statement, subgroup analyses in randomized controlled trials (RCTs) should be pre-planned and accompanied with a formal test of interaction. I considered the interaction between treatment and a dichotomous prognostic factor with a continuous outcome. I examined the impact of misspecifying the distribution of the prognostic factor on power and sample size for interaction effects. I found that power for the interaction test was decreased when the misspecification of the distribution of the prognostic factor was away from a balanced design. I also proposed three methods for improving the power under misspecifications. Quota sampling maintained the power at 80%, but trial completion may be delayed under misspecifications. Modified quota sampling improved the power, but results were related to the proportion of trials switching to the quota sampling procedure. Sample size re-estimation improved the power, but did not always attain 80% power. All three methods maintained appropriate type I error. Lastly, I examined the impact of unplanned cross-over on power and sample size for interaction effects in RCTs. Unplanned cross-over is common in surgical trials and can diminish the magnitude of the interaction effect. Due to this, the sample size re-estimation procedure performed better than quota sampling and modified quota sampling in the presence of unplanned cross-over.
2031-01-02
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McNellis, Jennie L. "Meta-analysis of Weight Change in the Placebo Arm of RCT’s for Weight Loss: Methods and Pilot Study." The University of Arizona, 2008. http://hdl.handle.net/10150/624315.
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Class of 2008 AbstractObjectives: 1) To determine if data on weight change in the placebo arm of RCT's for weight loss were available, and 2) to conduct a pilot meta-analysis to estimate the average weight change in the placebo arm. Methods: Four randomized placebo controlled trials of rimonabant for weight loss were retrieved. A draft data extraction form was developed to record weight loss and demographic data. Potential for bias was assessed on design issues related to withdrawals, blinding, allocation procedure, adherence, and manufacturer influence. Based on available data, a forest plot was constructed and heterogeneity was assessed. The a priori alpha level was 0.05. Results: The placebo groups from all studies were similar. The pooled data indicated that individuals in the placebo arm lost an average of 3.3 kg, p < 0.001. One study had a significantly greater completion rate than the other studies. Participants were prescribed a hypocaloric diet and were instructed to increase physical activity but no data were reported on calories consumed or amount of physical activity. Weight loss of 5% ranged from 15-20% of participants. There was potential for bias relating to reported adherence, allocation concealment process, and manufacturer funding. Conclusions: Participants in the placebo arm of rimonabant trials lost an average of 3.3 kg, which was statistically significant. Little can be learned about weight loss in the placebo arm because no data on calories consumed, amount of exercise, or hunger were reported. Information from other RCT's is needed to provide additional data and to confirm the findings.
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Gloster, Andrew T., Hans-Ulrich Wittchen, Franziska Einsle, Michael Höfler, Thomas Lang, Sylvia Helbig-Lang, Thomas Fydrich, et al. "Mechanism of action in CBT (MAC): methods of a multi-center randomized controlled trial in 369 patients with panic disorder and agoraphobia." Saechsische Landesbibliothek- Staats- und Universitaetsbibliothek Dresden, 2013. http://nbn-resolving.de/urn:nbn:de:bsz:14-qucosa-106614.
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Cognitive behavioral therapy (CBT) is efficacious for panic disorder with agoraphobia (PD/A). Nevertheless, the active ingredients of treatment and the mechanisms through which CBT achieves its effects remain largely unknown. The mechanisms of action in CBT (MAC) study was established to investigate these questions in 369 patients diagnosed with PD/A. The MAC study utilized a multi-center, randomized controlled design, with two active treatment conditions in which the administration of exposure was varied, and a wait-list control group. The special feature of MAC is the way in which imbedded experimental, psychophysiological, and neurobiological paradigms were included to elucidate therapeutic and psychopathological processes. This paper describes the aims and goals of the MAC study and the methods utilized to achieve them. All aspects of the research design (e.g., assessments, treatment, experimental procedures) were implemented so as to facilitate the detection of active therapeutic components, and the mediators and moderators of therapeutic change. To this end, clinical, behavioral, physiological, experimental, and genetic data were collected and will be integrated.
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Gloster, Andrew T., Hans-Ulrich Wittchen, Franziska Einsle, Michael Höfler, Thomas Lang, Sylvia Helbig-Lang, Thomas Fydrich, et al. "Mechanism of action in CBT (MAC): methods of a multi-center randomized controlled trial in 369 patients with panic disorder and agoraphobia." Technische Universität Dresden, 2009. https://tud.qucosa.de/id/qucosa%3A26684.
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Cognitive behavioral therapy (CBT) is efficacious for panic disorder with agoraphobia (PD/A). Nevertheless, the active ingredients of treatment and the mechanisms through which CBT achieves its effects remain largely unknown. The mechanisms of action in CBT (MAC) study was established to investigate these questions in 369 patients diagnosed with PD/A. The MAC study utilized a multi-center, randomized controlled design, with two active treatment conditions in which the administration of exposure was varied, and a wait-list control group. The special feature of MAC is the way in which imbedded experimental, psychophysiological, and neurobiological paradigms were included to elucidate therapeutic and psychopathological processes. This paper describes the aims and goals of the MAC study and the methods utilized to achieve them. All aspects of the research design (e.g., assessments, treatment, experimental procedures) were implemented so as to facilitate the detection of active therapeutic components, and the mediators and moderators of therapeutic change. To this end, clinical, behavioral, physiological, experimental, and genetic data were collected and will be integrated.
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Ward, Roxanne E. "Examining Methods and Practices of Source Data Verification in Canadian Critical Care Randomized Controlled Trials." Thèse, Université d'Ottawa / University of Ottawa, 2013. http://hdl.handle.net/10393/23974.
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Statement of the Problem: Source data verification (SDV) is the process of comparing data collected at the source to data recorded on a Case Report Form, either paper or electronic (1) to ensure that the data are complete, accurate and verifiable. Good Clinical Practice (GCP) Guidelines are vague and lack evidence as to the degree of SDV and whether or not SDV affects study outcomes.
Methods of Investigation: We performed systematic reviews to establish the published evidence-base for methods of SDV and to examine the effect of SDV on study outcomes. We then conducted a national survey of Canadian Critical Care investigators and research coordinators regarding their attitudes and beliefs regarding SDV. We followed by an audit of the completed and in-progress Randomized Controlled Trials (RCTs) of the Canadian Critical Care Trials Group (CCCTG).
Results: Systematic Review of Methods of SDV: The most common reported or recommended frequency of source data verification (10/14 - 71%) was either based on level or risk, or that it be conducted early (i.e. after 1st patient enrolled). The amount of SDV recommended or reported, varied from 5-100%. Systematic Review of Impact of SDV on Study Outcomes: There was no difference in study outcomes for 1 trial and unable to assess in the other. National Survey of Critical Care Investigators and Research Coordinators: Data from the survey found that 95.8% (115/120) of respondents believed that SDV was an important part of Quality Assurance; 73.3% (88/120) felt that academic studies should do more SDV; and 62.5% (75/120) felt that there is insufficient funding available for SDV. Audit of Source Data Verification Practices in CCCTG RCTs: In the national audit of in-progress and completed CCCTG RCTs, 9/15 (60%) included a plan for SDV and 8/15 (53%) actually conducted SDV. Of the 9 completed published trials, 44% (4/9) conducted SDV.
Conclusion: There is little evidence base for methods and effect of SDV on study outcomes. Based on the results of the systematic review, survey, and audit, more research is needed to support the evidence base for the methods and effect of SDV on study outcomes.
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Leichsenring, Falk, Jürgen Hoyer, Manfred Beutel, Sabine Herpertz, Wolfgang Hiller, Eva Irle, Peter Joraschky, et al. "The Social Phobia Psychotherapy Research Network: The First Multicenter Randomized Controlled Trial of Psychotherapy for Social Phobia: Rationale, Methods and Patient Characteristics." Karger, 2009. https://tud.qucosa.de/id/qucosa%3A27526.
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This paper presents the Social Phobia Psychotherapy Research Network. The research program encompasses a coordinated group of studies adopting a standard protocol and an agreed-on set of standardized measures for the assessment and treatment of social phobia (SP). In the central project (study A), a multicenter randomized controlled trial, refined models of manualized cognitive-behavioral therapy and manualized short-term psychodynamic psychotherapy are compared in the treatment of SP. A sample of 512 outpatients will be randomized to either cognitive-behavioral therapy, short-term psychodynamic psychotherapy or waiting list. Assessments will be made at baseline, at the end of treatment and 6 and 12 months after the end of treatment. For quality assurance and treatment integrity, a specific project using highly elaborated measures has been established (project Q). Study A is complemented by 4 interrelated add-on projects focusing on attachment style (study B1), on cost-effectiveness (study B2), on variation in the serotonin transporter gene in SP (study C1) and on structural and functional deviations of the hippocampus and amygdala (study C2). Thus, the Social Phobia Psychotherapy Research Network program enables a highly interdisciplinary research into SP. The unique sample size achieved by the multicenter approach allows for studies of subgroups (e.g. comorbid disorders, isolated vs. generalized SP), of responders and nonresponders of each treatment approach, for generalization of results and for a sufficient power to detect differences between treatments. Psychological and biological parameters will be related to treatment outcome, and variables for differential treatment indication will be gained. Thus, the results provided by the network may have an important impact on the treatment of SP and on the development of treatment guidelines for SP.Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.
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Mukaka, Mavuto. "Comparison of statistical methods of handling missing binary outcome data in randomized controlled trials of efficacy studies." Thesis, University of Liverpool, 2013. http://livrepository.liverpool.ac.uk/14593/.
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The presence of some missing outcomes in randomized studies often complicates the estimation of measures of effect, even in well designed randomized controlled trials. The process may be complicated further when the efficacy rates are close to 0% or 100% as the standard binomial model is susceptible to model non-convergence. The main objective of this study was to compare the performance of multiple imputation (MI) and Complete Case analysis for dealing with missing binary outcomes when modeling a risk difference. Firstly, however, the binomial regression COPY method and the Cheung’s modified Ordinary Least Squares (OLS) method were examined using simulation processes for their appropriateness in risk difference modeling. It was found that the number of copies (for the COPY method) required to minimize non-convergence coincided with the number of copies that gave the most biased estimates of the true efficacy difference while increasing the number of copies made the problems of non-convergence and bias worse; using Cheung’s method, however, there was 100% convergence with unbiased estimates of effect size. Simulation methods were used to compare the performance of complete case (CC) analysis and several multiple imputation (MI) models for handling missing outcome data over a wide range of efficacy environments and missing value assumptions. When outcomes were missing at random (MAR) or completely at random (MCAR), MI analyses that included treatment group membership in the imputation calculations yielded unbiased estimates of efficacy differences. The CC method was found to be as good, and often better, than MI methods when outcomes were MAR or MCAR, with coverage close to 95% in many situations – but neither CC nor MI produced unbiased estimates of effect difference when outcomes were missing not at random (MNAR). It was concluded that CC and MI methods are equally good in terms of producing unbiased estimates of effect difference in most missing outcome situations, but applying the intention to treat principle (ITT) which requires all randomized patients to be included in the primary analysis of a RCT, MI should be adopted as the analysis method of first choice, accompanied by a secondary CC analysis for sensitivity purposes (i.e. to investigate the extent of any likely bias).
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Compton, Dickinson Stella J. "A feasibility trial of group cognitive analytic music therapy in secure hospital settings." Thesis, Anglia Ruskin University, 2014. http://arro.anglia.ac.uk/581523/.
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There are no large-scale outcome studies of music therapy in secure hospital settings for people who have committed serious offences. These patients have a right to expect evidence-based multi-disciplinary treatment (Duggan et al. 2006); NICE (2010). Music therapy therefore should take a form which can be integrated into the treatment pathway. A single site implementation of a mixed-methods patient preference randomised controlled trial investigated the clinical effectiveness of a manualised music therapy model called Group Cognitive Analytic Music Therapy (G-CAMT). This context-specific, time limited intervention incorporates theories from Group Analysis (Foulkes 1964) and Cognitive Analytic Therapy (Ryle and Kerr 2003). The central research question was ‘Is G-CAMT feasible and effective for offenders in a secure multi-disciplinary treatment setting?’ The research process followed the Medical Research Council framework for developing and evaluating complex interventions (Campbell et al. 2000, 2007). Twenty patients were recruited; those expressing no preference were randomised to treatment or control arms. The two music therapists and the principal investigator were masked to their allocation status. Those in the treatment arm were allocated to one of two treatment groups of five, each run individually by one of the music therapists. Each group had sixteen ninety minute weekly sessions with followup at eight weeks. Treatment and control groups received standard care. The primary measure was the Person’s Relating to Others Questionnaire (Birtchnell and Evans 2004) Secondary measures were the Basic Empathy Scale (Jolliffe and Farrington 2006a), The Multi-Scale Dissociation Inventory (Briere, 2002) and an observational measure, the Chart of Interpersonal Reactions in Closed Living Environments (Blackburn and Glasgow, 1993). Quantitative data from these measures were examined for associations with qualitative data from semi-structured interviews administered to the music therapists and analyzed using Interpretative Phenomenological Analysis (Smith et.al. 2009) Findings from the results of the primary measure demonstrated statistically significant (Mann Whitney U: p<.05) reductions in favour of the treatment group compared to the control, in intrusive, restrictive and possessive behaviors and helpless or self-denigrating behaviours. There were improvements over time within the treatment group in the domains of sociability and hostility (Friedman Test :p<.04). The use of a manual was shown to help the music therapists manage the risk of violence without constraining their creativity. Two years after the end of the treatment 78% of treatment participants had moved to conditions of lower security over a mean period of 19 months compared with 66% of control subjects over a mean period of 25.5 months. The thesis concludes by situating G-CAMT amongst contemporary music therapy models.
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Rebele, Stephan F. [Verfasser], and Markus [Akademischer Betreuer] Hürzeler. "Tunnel technique with connective tissue graft versus coronally advanced flap with enamel matrix derivative for root coverage : a randomized controlled clinical trial using 3D digital measuring methods." Freiburg : Universität, 2015. http://d-nb.info/1119805813/34.
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Hodgson, Nicole Christina Fink. "The search for the ideal method of abdominal fascial closure, a meta-analysis, a provincial survey and a randomized controlled trial proposal." Thesis, National Library of Canada = Bibliothèque nationale du Canada, 1999. http://www.collectionscanada.ca/obj/s4/f2/dsk1/tape8/PQDD_0003/MQ42158.pdf.
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Riley, Dana L. "A Social Ecological Approach to Understanding Physical Activity. A Mixed Methods Exploration of the Individual, Family and Neighbourhood Characteristics That Influence Physical Activity Among Family Heart Health: Randomized, Controlled Trial Participants." Thèse, Université d'Ottawa / University of Ottawa, 2012. http://hdl.handle.net/10393/22946.
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Study 1 - Individual - The purpose was to determine whether a 12-week behavioural risk reduction intervention caused self-reported MVPA to increase and to identify associated Theory of Planned Behaviour (TPB) constructs. Three hundred twenty-four physically inactive (<150 minutes/week moderate-vigorous PA) participants were included. Intervention participants were significantly more likely to meet PA guidelines at 12-weeks (OR=3.54, 95% CI 2.22-5.63, p<.001), which was significantly correlated with increases in TPB constructs. // Study 2 - Family - Semi-structured interviews were conducted with 36 participants to elicit perceptions of factors that influence PA. Interviews were audiotaped, transcribed, coded and analyzed. Spouses were more likely to engage in PA with their spouse after the CHD event; however this may be limited by their partners’ capabilities. The data suggests awareness of an increased susceptibility to CHD is not stimulating participants to increase their own PA to prevent future risk, particularly among offspring, but they may take other actions. The shared family environment can promote PA, although intensity may be limited. // Study 3 - Neighbourhood - Self-reported PA from a prospective behavioural risk reduction intervention was explored in the context of objectively measured Walk Scores and neighbourhood walkability in Ottawa, Canada. Participants in the intervention arm had significantly higher odds of meeting PA guidelines at 12-weeks compared to the standard care control group. This was not influenced by Walk Scores or walkability. This individual-level intervention was effective in assisting participants to overcome potential structural barriers presented by their neighbourhood to meet PA guidelines at 12-weeks.
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Holmlund, Thorbjörn. "Evaluation of surgical methods for sleep apnea and snoring." Doctoral thesis, Umeå universitet, Institutionen för klinisk vetenskap, 2016. http://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-118944.
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Background: Snoring and obstructive sleep apnea (OSA) are both common disorders with a number of negative health effects. The safety and efficacy of treating snoring and OSA surgically have been questioned and there has been a lack of studies in the field. Aims: 1) To investigate the frequency of serious complications, including death, after surgery for the treatment of snoring and sleep apnea; 2) to evaluate the effect on daytime sleepiness after radiofrequency surgery of the soft palate in snoring men with mild or no OSA; 3) to evaluate the effect of tonsillectomy on sleep apnea in adults with OSA and tonsillar hypertrophy; 4) to investigate the morphology and cytoarchitecture of muscle fibers in human soft palatal muscles with immunohistochemical and morphological techniques. Methods and results: In paper 1, a retrospective database study. All Swedish adults who were treated surgically because of snoring or OSA from January 1997 to December 2005 were identified in the National Patient Register. None of the surgically treated patients died in the peri- and postoperative period. Severe complications were recorded in 37.1 of 1,000 patients treated with uvulopalatopharyngoplasty (UPPP), in 5.6 of 1,000 patients after uvulopalatoplasty (UPP) and in 8.8 of 1,000 patients after nasal surgery. In paper 2, the study was designed as a randomized, controlled trial. 35 snoring men with mild or no OSA were randomized to either radiofrequency or sham surgery of the soft palate. Radiofrequency surgery was not found to be effective since there was no significant difference between the two groups in relation to the Epworth Sleepiness Scale (ESS) or apnea-hypopnea index (AHI) at follow-up. Paper 3 was a prospective study, including 28 patients with an AHI of >10 and with large tonsils. In these patients, tonsillectomy was an effective treatment for OSA; the mean AHI was reduced from 40 units/h to 7 units/h (p<0.001), and the mean ESS was reduced from 10.1 to 6.0 (p<0.001) at the six-month follow-up after surgery. Minor and moderate swallowing dysfunction was found in seven of eight patients investigated before surgery and the swallowing function improved in 5 of them after surgery, while no one deteriorated. In paper 4, we investigated the morphology and cytoarchitecture in normal soft palate muscles. Human limb muscles were used as reference. The findings showed that the soft palate muscle fibers have a cytoskeletal architecture and cellmembrane complex that differs from that of the limb muscles. Conclusions No case of death related to surgery was found among 4,876 patients treated with UPPP, UPP or nasal surgery for snoring or OSA in Sweden between 1997 and 2005. Radiofrequency surgery of the soft palate has no effect on daytime sleepiness, snoring or apnea frequency in snoring men with mild or no OSA. Tonsillectomy can be an effective treatment for OSA in adults with large tonsils. A subgroup of muscle fibers in the human soft palate appears to have special biomechanical properties and their unique cytoarchitecture must be taken into account while assessing function and pathology in oropharyngeal muscles.Snarkning och obstruktiv sömnapné (OSA) är idag en global folksjukdom. Snarkning är det ”oljud” som uppstår när luftvägen under sömn förminskas och vävnaden börjar vibrera under andning. Vid obstruktiv sömnapné faller vävnaden samman och blockerar luftflödet till lungorna. Ett andningsuppehåll, en s.k. apné inträffar. Ett andningsuppehåll kan pågå allt ifrån några sekunder till mer än en minut och kan uppstå hundratals gånger per natt. För att klassificeras som en patologisk apné enligt internationell standard måste andningsuppehållet vara längre än 10 sek. Snarksjukdomen förvärras sannolikt över tid och övergår succesivt i obstruktiv sömnapné med ökande antal andningsuppehåll under sömn. Detta leder till ett stresspåslag för kroppen med oftast uttalad dagtrötthet och en mängd negativa hälsoeffekter. Snarksjukdom och sömnapné ökar risken för bl.a. högt blodtryck och hjärt-kärlsjukdom samt också för att den drabbade ska orsaka trafikolyckor på grund av försämrad koncentrationsförmåga och trötthet. En del av den negativa utvecklingen från snarkning till sömnapné anses bero på att snarkvibrationer kan ge neuromuskulära skador i gom och svalg. Dessa vävnadsskador anses också vara orsaken till att personer som snarkat länge ofta uppvisar störd sväljningsfunktion i form av felsväljning, där maten i uttalade fall hamnar i luftstrupen istället för i matstrupen. I dagsläget är förstahandsbehandling vid sömnapné CPAP, en mask som placeras över näsa och mun och som skapar ett övertryck i luftvägen vilket förhindrar att luftvägen faller samman och att andningsstopp uppstår. CPAP har enligt flera studier den bästa effekten mot andningsuppehåll. En annan vanlig behandling är en bettskena som för underkäken nedåt och framåt så att luftvägen bli mer öppen. Bettskenan är en vanlig och effektiv behandlingsmetod för personer utan kraftig övervikt vid vanemässig snarkning eller måttlig sömnapné. För ett tjugotal år sedan var kirurgi förstahandsmetoden vid behandling av snarkning och måttlig sömnapné. Man utförde då ofta operationer i svalg och gomm, s.k. gomplastiker. Bruket av kirurgisk behandling har dock minskat med tiden, dels p.g.a. biverkningar men också för att det saknades vetenskapliga studier som bevisade att kirurgin gav önskad och långsiktig effekt. Kirurgi utgör dock fortfarande ett komplement till behandling av snarkning och sömnapné när CPAP eller bettskena av olika skäl inte fungerar eller kan tolereras av patienten. 8 Även barn kan lida av snarkning och sömnapné men behandlingsprinciperna för barn skiljer sig från dem hos vuxna och berörs inte i avhandlingen. I denna avhandling studeras: i) biverkningsfrekvenser efter olika typer av snarkkirurgi, ii) effekten av radiovågsbehandling i mjuka gommen på vuxna män med snarkning, iii) effekten av att operera bort halsmandlarna på vuxna med sömnapné och stora halsmandlar, iv) muskelvävnadens struktur och molekylära uppbyggnad i mjuka gommen hos friska personer som inte snarkar. Avhandlingen består av fyra delstudier: 1. En registerstudie med kartläggning av svåra biverkningar efter kirurgi i form av uvulopalatopharyngoplastik, uvulupalatoplastik samt näskirurgi för behandling av sömnapné och snarkning och utfört i Sverige mellan åren 1997-2005. Studien omfattade 4 876 patienter. Inga dödsfall noterades. Komplikationsrisken var störst vid operationer där man tog bort delar av mjuka gommen samt halsmandlarna, där i snitt 37 av 1000 opererade fick biverkningar, framförallt p.g.a. infektioner eller blödningar. 2. I en prospektiv, randomiserad placebostudie utvärderades effekten av radiovågsbehandling i mjuka gommen vid snarkning och lindrig sömnapne. Trettiotvå patienter lottades till att få radiovågsbehandling eller placebo behandling. Patienterna visste inte vilken grupp de tillhörde. Vid uppföljning efter 12 månader var det inga statistiska belägg för att radiovågsbehandling minskade vare sig antal andningsuppehåll eller dagtrötthet. 3. Effekten av att ta bort halsmandlarna på patienter med stora halsmandlar och olika grad av sömnapné utvärderades i denna studie. Totalt deltog 28 patienter. Vid uppföljning 6 månader efter operationen hade antalet andningsuppehåll sjunkit drastiskt, från i snitt 40 till 7 andningsuppehåll per timme nattsömn. Inga allvarliga biverkningar uppstod. Dessa fynd talar för att man som förstahandsmetod ska erbjuda patienter med sömnapné och stora halsmandlar att ta bort halsmandlarna. 4. I detta projekt undersökte vi utseendet och uppbyggnaden av cellskelettet i två normala muskler i mjuka gommen hos friska personer utan känd snarkning och sömnapné. Muskler från armar och ben användes som referens. Fynden i studien visar att de normala muskelfibrernas uppbyggnad i mjuka gomen skiljer sig från jämförade muskler i armar och ben. Detta kan vara ett uttryck för en evolutionär utveckling för att möjligöra de komplexa funktioner som krävs av svalgets muskulatur. 9 Sammanfattningsvis kan vi konstatera: Att inga dödsfall har skett i Sverige efter operationer i gom, svalg eller näsa, utförda för att behandla snarkning och sömnapné under åren 1997 till 2005. Att radiovågsbehandling av mjuka gommen hos snarkande män med lindrig sömnapné inte har någon effekt på dagtrötthet, snarkning eller andningsuppehåll vid uppföljning efter 12 månader. Metoden kan därför inte rekommenderas. Att när man opererar bort stora halsmandlar på personer med andningsuppehåll så leder detta ofta till att andningsuppehållen minskar drastiskt. Metoden kan därför oftast rekommenderas som en förstahandsbehandling för denna patientgrupp. Att mjuka gommens muskelfibrer är uppbyggda på ett unikt sätt indikerar att deras specifika biomekaniska egenskaper skiljer sig från referens muskler i armar och ben.
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Finne, Emily, Melanie Glausch, Anne-Kathrin Exner, Odile Sauzet, Friederike Stölzel, and Nadja Seidel. "Behavior change techniques for increasing physical activity in cancer survivors: a systematic review and meta-analysis of randomized controlled trials." Dove Medical Press, 2018. https://tud.qucosa.de/id/qucosa%3A33823.
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Purpose: The purpose of this systematic review and meta-analysis is to investigate how physical activity (PA) can be effectively promoted in cancer survivors. The effect of PA-promoting interventions in general, behavior change techniques (BCTs), and further variables as moderators in particular are evaluated.
Methods: This study included randomized controlled trials of lifestyle interventions aiming at an increase in PA that can be carried out independently at home, published by December 2016, for adults diagnosed with cancer after completion of the main treatment. Primary outcomes were subjective and objective measures of PA prior to and immediately after the intervention. Meta-analysis and meta-regression were used to estimate effect sizes (ES) in terms of standardized mean differences, variation between ES in terms of heterogeneity indices (I2), and moderator effects in terms of regression coefficients.
Results: This study included 30 studies containing 45 ES with an overall significant small positive effect size of 0.28 (95% confidence interval=0.18–0.37) on PA, and I2=54.29%. The BCTs Prompts, Reduce prompts, Graded tasks, Non-specific reward, and Social reward were significantly related to larger effects, while Information about health consequences and Information about emotional consequences, as well as Social comparison were related to smaller ES. The number of BCTs per intervention did not predict PA effects. Interventions based on the Theory of Planned Behavior were associated with smaller ES, and interventions with a home-based setting component were associated with larger ES. Neither the duration of the intervention nor the methodological quality explained differences in ES.
Conclusion: Certain BCTs were associated with an increase of PA in cancer survivors. Interventions relying on BCTs congruent with (social) learning theory such as using prompts and rewards could be especially successful in this target group. However, large parts of between-study heterogeneity in ES remained unexplained. Further primary studies should directly compare specific BCTs and their combinations.
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Lyons, I. "The Medicines Advice Service Evaluation (MASE) : a mixed methods randomised controlled trial of an intervention to improve medication adherence in a mail-order pharmacy population." Thesis, University College London (University of London), 2015. http://discovery.ucl.ac.uk/1471595/.
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Non-adherence to medicines for long-term conditions is a complex and prevalent phenomenon, with significant clinical and economic consequences for patients and health providers worldwide. Simple effective solutions have eluded researchers over many decades. A mixed methods randomised controlled trial was conducted to test the effectiveness of a pharmacist-led intervention to improve adherence, in the context of mail-order pharmacy. 677 patients prescribed at least one oral medication for type 2 diabetes and/or lipid regulation were recruited from a UK pharmacy, and randomised (340 interventions, 337 controls). The intervention was patient-centred, comprising spoken information and advice by phone, and written information by post, delivered by a pharmacist. All elements of the intervention were tailored to the individuals' needs. The primary outcome was self-reported adherence to medication at six-month follow up. Secondary outcomes included prescription refill adherence, lipid and glycaemic control, and patient satisfaction. Patients who received the intervention had 54% increased odds of being adherent (defined as ≥90% of medication taken in the past 7 days), compared to the control group (OR 1.54, 95%CI 1.11-2.15, p=0.01). Analyses of dispensing data also showed that the odds of being classified as adherent (≥90%) were 60% greater for the intervention group compared to the control group (OR 1.60, 95%CI 1.14-2.24, p < 0.01). For patients who provided a blood sample at six-month follow up, 67% vs 31% (16 interventions, 5 controls, p=0.06) and 65% vs 55% (64 interventions, 38 controls, p=0.24) achieved guideline targets for glycaemic and lipid control, respectively. Satisfaction with the Medicines Advice Service was high, with 91.8% (n=245) agreeing that they were satisfied overall. Intervention, led by a pharmacist and tailored to the individuals' needs, can significantly improve medication adherence in patients with long-term conditions. The findings provide further support for the enhanced role of pharmacists in supporting and advising patients, and improving outcomes.
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Hughes-Morley, Adwoa. "What are effective methods to recruit research participants into mental health trials?" Thesis, University of Manchester, 2017. https://www.research.manchester.ac.uk/portal/en/theses/what-are-effective-methods-to-recruit-research-participants-into-mental-health-trials(00c200de-b35f-4389-b9a4-afdfb9205453).html.
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Background: There is a great need for effective treatments for mental health problems. Randomised controlled trials are the gold standard for evaluating treatments, however recruitment into trials is challenging, highlighting a clear need for evidence-based recruitment strategies. This thesis aimed to systematically develop a recruitment intervention and evaluate its effectiveness for improving the recruitment of participants into mental health trials. Methods: A mixed-methods approach, adopting the Medical Research Council’s complex interventions framework: 1) a systematic review to identify the evidence base and describe the factors affecting recruitment into depression trials; 2) a qualitative study to understand patients’ decision-making process in declining to enrol in a depression trial; 3) development of a recruitment intervention, using Participatory Design methods; and 4) evaluation of the recruitment intervention, using a randomised controlled trial, embedded in an ongoing mental health trial (the EQUIP trial). The primary outcome was the proportion of participants enrolled in EQUIP. Results: From the systematic review, a conceptual framework of factors influencing the decision to participate was developed, which highlighted that the decision to enrol involves a judgement between risk and reward. Findings suggested that patient and public involvement in research (PPIR) might be advertised to potential participants to reduce such perceived risk. The qualitative study found positive views of trials. Interviewees’ decision making resembled a four-stage process; in each stage they either decided to decline or progressed to the next stage. In Stage 1, those with an established position of declining trials opted out – they are termed ‘prior decliners’. In Stage 2, those who opted out after judging themselves ineligible are termed ‘self-excluders’. In Stage 3, those who decided they did not need the trial therapy and opted out are termed ‘treatment decliners’. In Stage 4, those who opted out after judging that disadvantages outweighed advantages are termed ‘trial decliners’. While ‘prior decliners’ are unlikely to respond to trial recruitment initiatives, the factors leading others to decline are amenable to amelioration as they do not arise from a rejection of trials. We recruited a host mental health trial (EQUIP), and worked with key stakeholders, including mental health service users and carers, to develop an intervention using a leaflet to advertise the nature and function of the PPIR in EQUIP to potential trial participants. 34 community mental health teams were randomised and 8182 patients invited. For the primary outcome, 4% of patients in the PPIR group were enrolled versus 5.3% of the control group. The intervention was not effective for improving recruitment rates (adjusted OR= 0.75, 95% CI= 0.53 to 1.07, p=0.113). Conclusions: This thesis reports the largest ever trial to evaluate the impact of a recruitment intervention. It also reports the largest trial of a PPIR intervention and makes a contribution to the evidence base on trial recruitment as well as to that assessing the impact of PPIR. Two further embedded trials are underway to evaluate the effectiveness of different versions of the recruitment intervention in different trial contexts and patient populations. This will also allow the results to be pooled to generate a more precise estimate of effect; to evaluate the impact of the intervention on trial retention; and to explore patient experiences of receiving the intervention.
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Gupta, Samir. "A randomised controlled trial of two methods of delivering continuous positive airway pressure for successful extubation in pre-term infants : 'infant flow driver' versus 'bubble CPAP'." Thesis, University of Newcastle upon Tyne, 2007. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.442225.
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Christmas, Pauline Mary. "A randomised controlled trial and systematic review comparing two methods of constraint induced movement therapy to improve upper limb function in pre-school children with hemiplegic cerebral palsy." Thesis, University of Birmingham, 2016. http://etheses.bham.ac.uk//id/eprint/6571/.
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Constraint induced movement therapy (CIMT) which is supported by motor learning theory has demonstrated promising results in improving upper limb function in hemiplegic cerebral palsy (HCP). However, its effectiveness within the NHS where children in the UK usually receive their therapy is little understood. To provide clarification, the author conducted a randomised controlled trial (n = 62) in 16 NHS paediatric community therapy services which compared the feasibility and effectiveness of a novel approach (prolonged restraint) of CIMT with usual NHS practice, in the young child with HCP. The primary outcome was bimanual performance measured with the Assisting Hand Assessment (AHA). Immediately post-intervention both groups changed and although there was not a statistically significant group difference the prolonged restraint methodology resulted in a larger effect (0.5 versus 0.2). The novel approach was safe, feasible, and acceptable to families and a more effective method of treatment delivery. The trial findings were combined in a systematic review and meta-analysis with a similar study and a treatment effect of 0.92 AHA logits was demonstrated. This is compatible with the smallest detectable difference (0.97 logits) indicating actual change in bimanual performance. The short-term efficacy, excellent recruitment and retention rates and acceptability of the trial procedures provides support for the trial feasibility and the need for a definitive investigation.
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Hill, Jacqueline Janet. "Stepped care for depression : a systematic review and feasibility study." Thesis, University of Exeter, 2016. http://hdl.handle.net/10871/23846.
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Background. Stepped care is widely implemented as a means to organise depression treatment. However, it is unclear how this system and the system it was designed to replace – long-term intensive psychotherapy for all – compare. Aim. To further the development and evaluation of stepped care. Specifically, assess the clinical effectiveness of stepped care and prepare for a fully-powered evaluation of stepped care vs. high-intensity psychotherapy alone for depressed adults. Design. A systematic review and mixed methods feasibility study encompassing a pilot randomised controlled trial and semi-structured interviews. Results of the systematic review. Fourteen randomised controlled trials involving 4580 participants were included. Relative to controls, there was significantly greater improvement in depression for adults treated with stepped care (d=0.34 at six months; 95% CI 0.20 to 0.48). The quality of included studies was good and there was little evidence of publication bias. All comparisons were with usual care. Results of the feasibility study. 66 patients were recruited to the pilot trial. The recruitment rate was 2.9% and follow-up data was obtained from 90.9% of participants. A third of stepped care patients stepped up to high-intensity therapy. Patients improved in both groups: the mean reduction in depressive symptoms was 13.4 in the stepped care group and 13.6 in the high-intensity therapy alone group. Recruitment methods were appropriate to patients and therapists but only somewhat appropriate to IAPT staff. Although the stepped care intervention was broadly acceptable to therapists, patient experience varied and some patients who demonstrated a low level of self-efficacy declined any therapy or dropped out of treatment. Conclusions. The effectiveness of stepped care compared with long-term intensive psychological therapy for all has not yet been established. A fully-powered trial of stepped care vs. high-intensity therapy alone is feasible although pilot trial methods and procedures should be modified to improve recruitment and acceptability.
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Feitosa, Flávio de Castro. "Comparação entre a colonoscopia com cromoscopia e com o NBI para detecção de displasia e neoplasias colônicas em pacientes com doença inflamatória intestinal de longa data: estudo randomizado e controlado." Universidade de São Paulo, 2013. http://www.teses.usp.br/teses/disponiveis/5/5168/tde-08082013-151359/.
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Introdução: Pacientes com doença inflamatória intestinal (DII) tem risco aumentado de desenvolvimento de displasias e neoplasias colônicas, a partir de 8 anos de diagnóstico da doença. O desenvolvimento de técnicas que melhorem a acurácia diagnostica destas displasias tem impacto científico, econômico e na prática clínica. Materiais and Métodos: O NBI (narrow band image) tem sido descrito como um método comparável à cromoscopia para a detecção de diversos tipos de cânceres do trato gastrointestinal superior e do sistema respiratório. Neste estudo, as duas técnicas foram comparadas em pacientes com DII de longa data. Resultados: 34 pacientes foram randomizados (18 para a cromoscopia e 16 para o NBI). 66,7% e 68,8% dos pacientes eram do gênero feminino, com média de idade de 48,5 e 49,6 anos, nos grupos cromoscopia e NBI, respectivamente. 61,1% dos pacientes do grupo cromoscopia e 56,2% do grupo NBI tinham doença de Crohn (DC). Nenhuma destas variáveis alcançou diferença estatísticamente significante na comparação entre os grupos: comportamento da DC, localização da retocolite ulcerativa, presença de atividade inflamatória endoscópica e sintomas no momento do exame. O tempo médio gasto para a realização do exame foi de 45,8 minutos no grupo cromoscopia e de 34,1 minutos no grupo NBI. Sobre a presença de displasias, 22,2% dos pacientes no grupo cromoscopia apresentaram lesões displásicas no exame histológico (todas as biopsias foram direcionadas pela presença de lesões), enquanto que, no grupo NBI, nenhuma lesão displásica foi encontrada (qui-quadrado= 4,477; ∑crítico> 3,841, considerando um erro a de 5%). Foram encontrados três lesões adenomatosas e uma lesão displásica tipo DALM (dysplasia-associated lesion or mass), típica da DII. Quando realizada a correção de Yattes, ara amostras pequenas, foi observado ∑ = 2,180 (∑crítico> 3,841, considerando um erro a de 5%). Conclusões: Esses dados mostram diferença estatística entre as técnicas endoscópicas (NBI e cromoscopia). Eles revelam uma forte tendência estatística de superioridade da cromoscopia, comparada ao NBI.Introduction: Patients with inflammatory bowel disease (IBD) are under increased risk of colonic dysplasia and neoplasia, approximately, 8 years after diagnosis. The development of techniques that improve the diagnostic ability to detect those dysplasias has scientific, economic and practical impact. Materials and Methods: The NBI (narrow band image) has been described as a valuable method comparable to chromoendoscopy for the detection of many cancers of the upper digestive and respiratory systems. The two techniques were compared in this study in patients with IBD after at least 8 years from diagnosis. Results: 34 patients were randomized (18 for chromoendoscopy and 16 for NBI). 66.7% and 68.8% were female, mean age of 48.5 and 49.6 years, in chromoendoscopy and NBI groups, respectively. The mean disease duration was 14.7 (DP 6.5 years 2) and 15.6 years (DP 9.0 years 2) for chromoendoscopy and NBI, respectively. 61.1% of patients in the chromoendoscopy group and 56.2% in the NBI had Crohn\'s disease (CD). None of those epidemiological data, extension and behavior of CD and Ulcerative Colitis, use of medications, endoscopic grade of disease activity and symptoms at the time of the exam disclosed statistical significance. The average time of examination was 45.8 minutes for the chromoendoscopy group, versus 34.1 minutes for the NBI group. Regarding the presence of dysplasia, 22,2% of patients in the chromoendoscopy group showed some dysplastic lesions on histological examination (all biopsies directed to mucosal lesions), while no patients in the NBI group had such lesions (chi-square = 4.477; ∑critical> 3.841, considering an error of 5%). We found three adenomas and one dysplastic lesions of the type DALM (dysplasia-associated lesion or mass), typical of IBD. When we look at correcting by means of the Yates correction test for small samples, we observed ∑ = 2,180 (∑critical > 3.841, considering an error of 5%). Conclusion: Those data have shown statistical difference between the endoscopic techniques (NBI and chromoendoscopy). They revealed a strong statistical tendency of superiority of chromoendoscopy compared to NBI.
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Forster, Jeri E. "Varying-coefficient models for longitudinal data : piecewise-continuous, flexible, mixed-effects models and methods for analyzing data with nonignorable dropout /." Connect to full text via ProQuest. Limited to UCD Anschutz Medical Campus, 2006.
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Thesis (Ph.D. in Biostatistics) -- University of Colorado at Denver and Health Sciences Center, 2006.Typescript. Includes bibliographical references (leaves 72-75). Free to UCD Anschutz Medical Campus. Online version available via ProQuest Digital Dissertations;
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Silva, Fernando Brandão de Andrade e. "Estudo clínico comparativo, prospectivo e randomizado das osteossínteses da clavícula com placa ou haste intramedular flexível." Universidade de São Paulo, 2014. http://www.teses.usp.br/teses/disponiveis/5/5140/tde-24102014-152044/.
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INTRODUÇÃO: As fraturas do terço médio da clavícula representam 80% das fraturas claviculares e seu tratamento é motivo de discussão na literatura ortopédica. Estudos prévios relativos ao tratamento cirúrgico têm demonstrado bons resultados clínicos com o uso das placas de reconstrução ou a fixação intramedular elástica estável com hastes flexíveis de titânio. O objetivo deste estudo foi a comparação desses métodos no tratamento das fraturas do terço médio da clavícula, quanto aos resultados funcionais, parâmetros radiográficos, dor pós-operatória, taxa de satisfação e taxa de complicações. MÉTODOS: Neste ensaio clínico comparativo, prospectivo e randomizado, 59 pacientes com fratura desviada do terço médio da clavícula foram alocados aleatoriamente para receberem osteossíntese com placa de reconstrução (33 pacientes - grupo Placa) ou haste flexível de titânio (26 pacientes - grupo Haste). O desfecho primário do estudo foi a avaliação funcional pelo escore DASH aos 6 meses de pós-operatório. Os desfechos secundários foram: o escore DASH aos 12 meses; o escore de Constant- Murley aos 6 e 12 meses; o tempo de consolidação da fratura; o encurtamento residual; o nível de dor pela escala visual analógica no 1º pósoperatório; a taxa de pacientes satisfeitos e a taxa de complicações. RESULTADOS: Cinquenta e quatro pacientes completaram o seguimento, sendo 29 do grupo Placa e 25 do grupo Haste. O escore DASH médio aos 6 meses foi de 9,9 pontos no grupo Placa e 8,5 no grupo Haste, sem diferença estatisticamente significante (p = 0,329). Da mesma forma, não houve diferenças significantes no escore DASH aos 12 meses ou no escore de Constant aos 6 e 12 meses. O tempo de consolidação foi equivalente entre os grupos (p = 0,352), enquanto o encurtamento residual foi maior no grupo Placa, com significância estatística (p = 0,032), mas sem relevância clínica (0,4 cm). Os resultados da escala visual analógica para dor no 1º pósoperatório e a taxa de pacientes satisfeitos foram similares entre os grupos. O grupo Placa apresentou mais casos com angulação do implante (11 casos) do que o grupo Haste (um caso) (p = 0,003), enquanto o grupo Haste foi mais associado à dor relacionada ao implante (10 casos), em comparação ao grupo Placa (4 casos) (p = 0,035). Não houve diferenças significantes entre os grupos quanto às complicações maiores, incluindo falha do implante, infecção pós-operatória, pseudoartrose e reoperação. CONCLUSÕES: A osteossíntese das fraturas desviadas do terço médio da clavícula com placa de reconstrução ou haste flexível de titânio produzem resultados semelhantes quanto aos escores funcionais, tempo de consolidação, dor pós-operatória, satisfação dos pacientes e complicações maiores. As placas de reconstrução são mais suscetíveis à angulação do implante, enquanto as hastes flexíveis de titânio causam mais dor relacionada ao implanteINTRODUCTION: Midshaft clavicle fractures represent 80% of all clavicular fractures, and their treatment is controversial in the literature. Previous studies have shown good clinical results in patients with midshaft clavicular fractures treated with reconstruction plate fixation or elastic stable intramedullary nailing (ESIN). The objective of this study was to compare these methods in terms of functional results, radiographic parameters, postoperative pain, satisfaction rates and complication rates. METHODS: In this prospective, randomized, controlled trial, 59 patients with displaced midshaft clavicular fractures were randomly assigned to receive either reconstruction plate (33 patients - Plate group) or ESIN fixation (26 patients - ESIN group). The primary outcome was the DASH score at 6 months. The secondary outcomes were the following: DASH score at 12 months; Constant-Murley scores at 6 and 12 months; time to fracture union; residual shortening; visual analog scale for pain on the first post-operative day; percentage of satisfied patients; and complications rates. RESULTS: Fifty-four patients completed the follow-up, 29 in the Plante group and 25 in the ESIN group. The mean DASH score at 6 months was 9.9 in the plate group and 8.5 in the ESIN group, with no significant difference (p = 0.329). Similarly, there were no differences in the DASH score at 12 months or the Constant-Murley scores at 6 and 12 months. The time to union was equivalent between the groups (p = 0.352), whereas the residual shortening was significantly greater in the plate group (p = 0.032) but was not clinically relevant (0.4 cm). The visual analog scale scores for pain and the percentage of satisfied patients were similar between the groups. Implant bending was significantly more common in the plate group (eleven patients) than in the ESIN group (one patient) (p = 0.003), whereas hardware-related pain was more frequent in the ESIN group (10 patients vs. 4 patients) (p = 0.035). There were no differences in terms of major complications, including implant failure, postoperative infection, nonunion and reoperation. CONCLUSIONS: Reconstruction plates and ESIN yielded similar results in terms of functional results, time to union, post-operative pain, patient satisfaction and major complications in patients with displaced midshaft clavicular fractures. Reconstruction plates are more susceptible to implant bending, whereas ESIN causes more hardwarerelated pain
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Suzumura, Erica Aranha. "Efeito da manobra de recrutamento alveolar em pacientes com síndrome da angústia respiratória aguda: revisão sistemática e metanálise." Universidade de São Paulo, 2015. http://www.teses.usp.br/teses/disponiveis/5/5137/tde-18062015-143438/.
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Objetivo: Avaliar o efeito das manobras de recrutamento alveolar em desfechos clínicos de pacientes com síndrome da angústia respiratória aguda (SARA). Métodos: Busca nas bases eletrônicas MEDLINE, EMBASE, LILACS, CINAHL, CENTRAL, Scopus, and Web of Science (até Julho de 2014), sem limite de idioma, por ensaios clínicos randomizados avaliando o efeito das manobras de recrutamento alveolar versus tratamento padrão sem manobras de recrutamento em pacientes adultos com SARA. Quatro duplas de revisores avaliaram de maneira independente a elegibilidade e o risco de viés dos estudos e extraíram os dados de interesse. Realizamos metanálise dos dados por meio de modelos de efeitos aleatórios. Foi utilizada análise sequencial de trials para estabelecer limiares de significância estatística para a metanálise cumulativa considerando nosso desfecho primário (mortalidade hospitalar) para limitar o erro tipo I global por análises múltiplas. Utilizamos sistema GRADE para avaliar a qualidade da evidência. Resultados: Foram incluídos 10 ensaios clínicos randomizados (1594 pacientes, 612 eventos). O risco relativo (RR) de óbito nos pacientes tratados com manobras de recrutamento em comparação ao controle foi de 0,84 (intervalo de 95% de confiança [IC95%] 0,74-0,95; I2=0%), embora a qualidade da evidência tenha sido considerada baixa devido ao risco de viés nos estudos incluídos e à evidência indireta (ou seja, a evidência disponível não responde diretamente nosso objetivo primário, pois os pacientes no grupo experimental receberam outras intervenções ventilatórias que podem ter impactado no desfecho, além das manobras de recrutamento). Não houve diferença no risco de barotrauma (RR 1,11; IC95% 0,78-1,57; I2=0%) ou necessidade de terapia de resgate para hipoxemia (RR 0,76; IC95% 0,41-1,40; I2=56%). A maioria dos estudos não demonstrou diferenças entre os grupos nos desfechos: tempo de ventilação mecânica, tempo de internação na UTI e no hospital. A análise sequencial de ensaios clínicos demonstrou que a evidência cumulativa sobre o efeito das manobras de recrutamento na mortalidade hospitalar de pacientes com SARA é precisa quando considerado um erro tipo I de 5%, mas é imprecisa quando considerado um erro tipo I de 1%. Conclusão: A evidência atual sugere que as manobras de recrutamento alveolar reduzem o risco de óbito hospitalar em pacientes com SARA, sem aumento do risco de eventos adversos graves, entretanto, a evidência não é definitiva. Estudos adicionais são necessários para responder esta questãoPurpose: To assess the effects of alveolar recruitment maneuvers on clinical outcomes in patients with acute respiratory distress syndrome (ARDS). Methods: We searched MEDLINE, EMBASE, LILACS, CINAHL, CENTRAL, Scopus, and Web of Science (from inception to July 2014) for randomized controlled trials evaluating the effects of alveolar recruitment maneuvers versus no recruitment maneuvers in adults with ARDS. We placed no language restriction on our search. Four teams of two reviewers independently assessed eligibility and risk of bias and extracted data from the included trials. We pooled data using random-effects models. We used trial sequential analysis to establish monitoring boundaries to limit global type I error due to repetitive testing for our primary outcome (in-hospital mortality). We rated the quality of evidence using the GRADE system. Results: We included 10 trials (1594 patients, 612 events). The meta-analysis assessing the effect of alveolar recruitment maneuvers on in-hospital mortality showed a risk ratio (RR) of 0.84 (95%CI 0.74-0.95; I2=0%). However, quality of evidence was considered low due to the risk of bias in the included trials and indirectness of evidence, that is, available evidence does not address our primary outcome directly as recruitment maneuvers were usually conducted along with other ventilatory interventions that may affect the outcome of interest. There were no differences in the rates of barotrauma (RR 1.11, 95%CI 0.78-1.57; I2=0%) or need for rescue therapies (RR 0.76, 95%CI 0.41-1.40; I2=56%). Most trials found no difference between groups regarding the duration of mechanical ventilation, length of stay in ICU and in hospital. The trial sequential analysis showed that the available evidence of the effect of recruitment maneuvers on in-hospital mortality is precise when considering a type I error of 5% but not when considering a type I error of 1%. Conclusions: Although recruitment maneuvers may decrease mortality of patients with ARDS without increasing the risk for major adverse events, the current evidence is not definitive. Additional trials addressing this question may better inform clinical practice
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Sousa, Ana Maria da Silva. "Influência da orientação telefônica sobre os resultados da automonitorização glicêmica de pacientes com diabetes mellitus gestacional." Universidade de São Paulo, 2014. http://www.teses.usp.br/teses/disponiveis/5/5139/tde-20012015-155617/.
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A Diabetes Mellitus Gestacional é definida como intolerância à glicose durante a gestação, excluídos os casos de diabetes pré-gestacional. A telemedicina tem sido citada como ferramenta útil para proporcionar melhor qualidade à saúde de portadores de doenças crônicas. Objetivo: analisar a influência da orientação telefônica feita por um profissional de saúde sobre os resultados da automonitorização glicêmica em pacientes com diabetes mellitus gestacional. Método: estudo randomizado controlado-cego, longitudinal, com gestantes diagnosticadas com diabetes gestacional, acompanhadas no Setor de Endocrinopatias e Gestação da Clínica Obstétrica do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo atendidas no período de agosto de 2012 a maio de 2014. O diagnostico de DMG foi realizado por meio de glicemia de jejum e teste de tolerância à glicose de 75 gramas. As pacientes foram convidadas a participar da pesquisa após receberem instruções de uma equipe multiprofissional. Foram alocadas, de acordo com a randomização em dois grupos: Grupo 1 (receberiam ligação telefônica três dias após as orientações multiprofissionais, n=122) e grupo 2 (não receberiam ligação telefônica n= 122),. A enfermeira ligou para as pacientes e aplicou questionário sobre manuseio do aparelho para verificação da glicemia capilar, dieta, horário de aferições, desconforto e dificuldade em realizar a automonitorização glicêmica. Foram analisados os valores glicêmicos por meio das porcentagens de valores alterados, de hiperglicemia, de hipoglicemia e da média glicêmica nos sete primeiros dias após a participação no grupo multiprofissional. O número de aferições glicêmicas e as respostas ao questionário aplicado durante o contato telefônico também foram analisados. Resultados: Não houve diferença estatisticamente significativa entre os grupos quanto à cor, idade, presença de outras doenças clínicas maternas e quanto ao tipo de teste usado para diagnóstico de diabetes mellitus gestacional. Analisando os valores da glicemia capilar, o grupo que recebeu orientações telefônicas apresentou menor porcentagem de valores alterados (p= 0,001), menor frequência de hiperglicemia (p= 0,002) e maior número de aferições da glicemia capilar (p= 0,001). Conclusões: O contato telefônico influenciou significativamente o número de aferições da glicemia capilar e a frequência de resultados alterados, especialmente na hiperglicemia, sugerindo ser essa ferramenta útil na melhora da atenção a gestantes portadoras de diabetes gestacionalGestational Diabetes Mellitus (GDM) is defined as glucose intolerance during pregnancy, excluding cases of pre-gestational diabetes. Telemedicine has been cited as useful tool to provide better quality health care for patients with chronic diseases. Objective: To analyze the influence of telephone advice, by a health care professional, on the results of blood glucose monitoring in patients with gestational diabetes. Method: A randomized controlled blind trial, in pregnant women diagnosed with gestational diabetes, attended in Setor de Endocrinopatias e Gestação da Clínica Obstétrica do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo was carried out from August 2012 to May 2014 The diagnosis of GDM was made by means of fasting glucose and glucose tolerance test 75 grams. Patients were invited to participate in the study after receiving instructions from a multidisciplinary team. According to randomization, patients were allocated into two groups: Group 1 (receive phone call three days after multidisciplinary instructions, n = 122) and group 2 (not receive phone call, n = 122). The nurse called the patient and applied questionnaire on handling the device for checking blood glucose, diet, time of measurements, discomfort and difficulty in performing the blood glucose monitoring. Glycemic values were analyzed by means of the percentage of abnormal values, hyperglycemia, hypoglycemia and glycemic average in the first seven days after participation in the multidisciplinary group. The number of glucose measurements and the questionnaire answer questionnaire were also analyzed. Results: There was no statistically significant difference between groups regarding race, age, presence of other maternal medical illnesses and the type of test used to diagnose gestational diabetes. Analyzing the glycemic values , a group that received telephone guidelines showed lower percentage of abnormal values (p = 0.001), lower incidence of hyperglycemia (p = 0.002) and greater number of measurements of blood glucose (p = 0.001) Conclusion: The telephone contact significantly influenced the number of measurements of blood glucose and the frequency of abnormal results, especially in hyperglycemia, suggesting that this is useful tool in improving attention to pregnant women with gestational diabetes
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Toniolo, Ricardo Alexandre. "Ensaio clínico randomizado, duplo-cego, controlado com placebo, de monoidrato de creatina como terapia adjuvante na depressão bipolar." Universidade de São Paulo, 2016. http://www.teses.usp.br/teses/disponiveis/5/5142/tde-07122016-150647/.
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Os episódios depressivos constituem a principal causa de morbidade e disfuncionalidade para indivíduos acometidos de transtorno bipolar (TB) ao longo do curso da doença. Os tratamentos disponíveis atualmente para esta fase do transtorno possuem eficácia limitada, o que implica na necessidade de pesquisas que busquem novas opções terapêuticas. Os prejuízos cognitivos presentes em todas as fases do TB, incluindo as depressivas, e associados em seu curso evolutivo a neuroprogressão consistem noutra dimensão psicopatológica que não é beneficiada pelos tratamentos farmacológicos atualmente empregados. Uma mudança de paradigma temse delineado na literatura nos últimos anos a partir do modelo de pesquisa translacional, na qual novas substâncias, incluindo nutracêuticos, têm sido propostas ou estudadas em ensaios clínicos no tratamento da depressão bipolar. Destacam-se entre estes compostos aqueles que atuam no metabolismo energético e na modulação de funções mitocondriais, em vista de extensa linha de evidências que aponta para a existência no TB de alterações fisiopatológicas nestes aspectos da neurobiologia. Escolhemos o monoidrato de creatina como suplemento alimentar a ser estudado como candidato a terapia adjuvante da depressão bipolar, especialmente em razão de sua atuação na bioenergética celular e na potencialização da cognição. Método: Conduzimos um ensaio clínico duplo-cego em que trinta e cinco (35) pacientes portadores de TB do tipo I ou II em episódio depressivo pelos critérios do DSM-IV e que se encontravam em uso de medicamentos preconizados para o tratamento desta fase da doença foram randomicamente alocados em dois grupos de tratamento adjuvante durante 6 semanas: monoidrato de creatina 6 gramas/dia (N=17) ou placebo (N=18). As comparações entre os grupos para as medidas de desfecho escolhidas, sendo determinada como primária a alteração na pontuação na MADRS (Montgomery-Asberg Depression Rating Scale) após 6 semanas, foram realizadas considerando em uma análise principal por intenção-de-tratar os 27 sujeitos (N=16 no grupo creatina; N=11 no grupo placebo) reavaliados em pelo menos uma ocasião ao longo do ensaio clínico, utilizando-se o método da last-observation-carried-forward (LOCF). Procedemos também a análises secundárias que avaliaram os desfechos clínicos de 23 pacientes (N=12 no grupo creatina; N=11 no grupo placebo) que completaram as 6 semanas e os desfechos cognitivos de 18 sujeitos (N=9 no grupo creatina; N=9 no grupo placebo) que foram submetidos a uma bateria de testes neuropsicológicos antes e após o tratamento de 6 semanas. Resultados: Não foram encontradas diferenças estatisticamente significativas entre os grupos de tratamento após 6 semanas nas variáveis clínicas analisadas por intençãode- tratar ou por-protocolo. O grupo creatina apresentou melhora significativa (p < 0,05) em comparação ao grupo placebo do desempenho no teste de fluência verbal após as 6 semanas de tratamento. Conclusão: O presente estudo, ressalvadas suas limitações metodológicas, não corrobora a hipótese de eficácia do monoidrato de creatina como terapia adjuvante da depressão bipolar, mas pode encorajar ensaios clínicos de duração mais prolongada e com amostras maiores que procurem confirmar o efeito potencializador da cognição da creatina nos indivíduos portadores de TBDepressive episodes are a major cause of morbidity and dysfunction in individuals suffering from bipolar disorder (BD) throughout the course of the disease. The currently available treatments for bipolar depression have limited efficacy, which implies the need for research on new therapeutic options. The cognitive deficits presented in all stages of BD including depressive and that are associated to neuroprogression consist in another psychopathological dimension which is not affected by current pharmacological treatments. A paradigm shift inspired by the translational research approach has been outlined in the literature in recent years, in which new substances, including nutraceuticals, have been proposed or studied in clinical trials for the therapy of bipolar depression. Prominent among these compounds are those that work in energy metabolism and modulation of mitochondrial function in view of extensive line of evidence pointing to the existence in BD of pathophysiological changes in these aspects of neurobiology. We chose to study the dietary supplement creatine monohydrate as a candidate for adjunctive therapy in bipolar depression, especially due to its role in cellular bioenergetics and enhancement of cognition. Methods: We conducted a double-blind trial in which thirty-five (35) patients with BD type I or II in a depressive episode by DSM-IV criteria and in use of regular medication for the treatment of this phase of the disease were randomly allocated into two adjunctive treatment groups for 6 weeks: creatine monohydrate 6 grams daily (N =17) or placebo (N = 18). Comparisons between groups for the chosen outcome measures, being determined as primary the change in score on the MADRS (Montgomery- Asberg Depression Rating Scale) after 6 weeks, were performed considering in a major analysis by intention-to-treat 27 subjects (N=16 in the creatine group; N=11 in the placebo group) reassessed on at least one occasion during the clinical trial using the method of the last-observation-carriedforward (LOCF). We also proceed to a secondary analysis that evaluated the clinical outcomes of 23 patients (N=12 in the creatine group; N=11 in placebo group) who completed the 6 weeks and the cognitive outcomes of 18 subjects (N=9 in the creatine group; N=9 in the placebo group) who were subjected to a battery of neuropsychological tests before and after the 6- week treatment. Results: There were no statistically significant differences between treatment groups after 6 weeks in the clinical variables analyzed by intention-to-treat and per-protocol. The creatine group showed significant improvement (p < 0.05) in the performance in the verbal fluency test when compared to the placebo group after the 6-week treatment. Conclusion: This study, although subject to methodological limitations, does not support the hypothesis of efficacy of creatine monohydrate as adjunctive therapy for bipolar depression, but it can encourage the execution of clinical trials of longer duration and with larger samples that seek to confirm the cognitiveenhancing effect of creatine in individuals with BD
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Möller, Hans. "Isthmic spondylolisthesis in adults : a randomized controlled trial /." Stockholm, 1999. http://diss.kib.ki.se/1999/91-628-3834-2/.
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Doiron, Jason. "Prevention of pathological gambling a randomized controlled trial /." access full-text online access from Digital Dissertation Consortium, 2005. http://libweb.cityu.edu.hk/cgi-bin/er/db/ddcdiss.pl?NR25497.
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Rosa, Moacyr Alexandro. ""Estimulação magnética transcraniana de repetição: comparação da eficácia com a eletroconvulsoterapia"." Universidade de São Paulo, 2004. http://www.teses.usp.br/teses/disponiveis/5/5142/tde-12082005-152200/.
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Os estudos publicados nos últimos anos sobre a utilização da estimulação magnética transcraniana de repetição (EMTr) têm sugerido significativas ações antidepressivas. Neste trabalho foi realizado um estudo comparativo da EMTr com a eletroconvulsoterapia (ECT) que é um método consagrado para o tratamento de transtornos depressivos. Foi feita, em primeiro lugar, uma extensa revisão a respeito destes dois métodos de tratamento não medicamentoso, expondo a sua história, a sua eficácia, as principais indicações, contra-indicações e efeitos colaterais, além dos possíveis mecanismos de ação, que ainda não estão completamente esclarecidos. A seguir foi realizado um ensaio clínico controlado, randomizado, simples-cego, comparando a eficácia de ambos para o tratamento da Depressão Maior unipolar refratária, sem sintomas psicóticos, com indicação de ECT. Também foi realizada uma avaliação dos efeitos cognitivos, especialmente da memória. Trinta e cinco pacientes foram incluídos. A eletroconvulsoterapia foi realizada com indução anestésica geral e relaxamento muscular. Foram feitas aplicações na posição unilateral direita com carga 4,5 vezes o limiar convulsígeno. A EMTr foi aplicada no córtex pré-frontal dorso-lateral esquerdo com intensidade de 100% do limiar motor. Os pacientes receberam 20 sessões (cinco dias por semana por quatro semanas), com 25 séries de estimulação por dia (com freqüência de 10 Hz por 10 segundos, com intervalos de 20 segundos). As escalas de avaliação foram aplicadas nos tempos basal, após duas semanas de tratamento e após quatro semanas de tratamento. Ambos os tratamentos tiveram eficácia equivalente, com uma taxa de redução média dos escores na escala de Hamilton para depressão de 42 %, uma resposta clínica de 46 % e uma taxa de remissão de 14%. A EMTr apresentou um perfil mais benigno de efeitos colaterais (cefaléia em 1 %). A ECT resultou em cefaléia (em 20 %) e náuseas (em 10%).Não houve diferença nos efeitos cognitivos entre os dois tratamentos, tendo ambos se mostrado bastante benignos. Este estudo é uma contribuição para a crescente literatura a respeito do assunto e sugere um efeito antidepressivo da EMTr, comparável ao da ECT em pacientes com depressão maior unipolar sem sintomas psicóticosStudies published over the past few years suggest that repetitive transcranial magnetic stimulation (rTMS) may have significant antidepressant actions. This work performs a comparison between rTMS and electroconvulsive therapy (ECT), an established method to treat depression disorders. First there was an extensive review on the knowledge of both non pharmacological treatments including their history, efficacy, main indications, contraindications and side effects, in addition to the possible mechanisms of action, not yet fully understood. After that, a controlled randomized, single-blind clinical trial was conducted, comparing the efficacy to treat unipolar resistant nonpsychotic major depression that were referred to receive ECT. An evaluation of cognitive effects was also performed, specially memory effects. Thirty five patients were included. Electroconvulsive therapy was performed with general anesthesia and muscular relaxation. Right unilateral electrodes positioning was used, with a charge 4.5 times the convulsive threshold. rTMS was performed over the left dorsolateral prefrontal cortex at 100% motor threshold. Patients were treated with 20 sessions (five times per week for four weeks) with 25 trains a day (frequency of 10 Hz, duration of 10 seconds with 20 seconds intertrain interval). Patients were evaluated at baseline, after two weeks and after four weeks of either treatment. Both groups were equivalent in efficacy, showing a means of reduction on Hamilton depression rating scale of 42%, an overall clinical response of 46% and a remission rate of 14%. rTMS showed a more benign profile regarding side effects (headache on 1%). ECT induced headache (20%) and nausea (10%). No cognitive effects were observed on either treatments. This study adds to the growing literature supporting an antidepressant effect for rTMS, similar to ECT on patients with unipolar nonpsychotic major depression
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Melo, Sissy Lara. "Ablação do istmo cavo-tricuspídeo para controle do flutter atrial: estudo prospectivo e randomizado comparando eficácia e segurança de cateter irrigado com cateter de 8 mm." Universidade de São Paulo, 2005. http://www.teses.usp.br/teses/disponiveis/5/5131/tde-20102005-150207/.
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O cateter irrigado foi comparado com o de 8 mm para ablação com radiofrequência do istmo cavo-tricuspídeo(Ist-CT). Foram randomizados 52 pacientes portadores de flutter atrial típico para ablação com cateter irrigado(grupoI) ou com cateter de 8 mm(grupo II). O bloqueio do Ist-CT foi obtido em 51 pacientes. Não houve diferença estatística em relação aos parâmetros de aplicação de RF entre os dois grupos. A ablação do Ist-CT com cateter irrigado versus cateter de 8mm foi igualmente eficaz e segura no controle do flutter atrial típico.A 4-mm cooled tip catheter was compared to an 8-mm tip catheter to cavotricuspid isthmus(CTI) ablation. This prospective study enrolled 52 patients with typical atrial flutter to ablation with a closed cooled-tip catheter(group1) or an 8-mm tip catheter. Radiofrequency(RF) applications were performed to achieve complete CTI block wich was achieved in 51 patients. No significant differences were found in the procedure parameters. CTI ablation with an irrigated tip catheter versus an 8-mm tip catheter was equally effective and satisfactorily safe for ablation of typical atrial flutter.
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Wong, Ho-hang Anthony. "A randomized controlled trial of home tooth-whitening products." Click to view the E-thesis via HKUTO, 2004. http://sunzi.lib.hku.hk/hkuto/record/B3195439X.
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Bukusi, Elizabeth Anne. "Bacterial vaginosis : a randomized controlled trial to prevent recurrence /." Thesis, Connect to this title online; UW restricted, 2006. http://hdl.handle.net/1773/10880.
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Wong, Ho-hang Anthony, and 黃浩行. "A randomized controlled trial of home tooth-whitening products." Thesis, The University of Hong Kong (Pokfulam, Hong Kong), 2004. http://hub.hku.hk/bib/B3195439X.
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Gracitelli, Mauro Emilio Conforto. "Estudo randomizado da osteossíntese das fraturas da extremidade proximal do úmero com placa ou haste intramedular." Universidade de São Paulo, 2015. http://www.teses.usp.br/teses/disponiveis/5/5140/tde-24022016-091653/.
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INTRODUÇÃO: As fraturas da extremidade proximal do úmero são frequentes, com incidência crescente no idoso e com impacto na qualidade de vida e na função do ombro. Para os casos com desvio, a placa bloqueada é o método mais utilizado de osteossíntese. Bons resultados clínicos são obtidos tanto com a placa bloqueada como com a haste intramedular bloqueada. O objetivo do estudo foi a comparação desses métodos no tratamento das fraturas da extremidade proximal do úmero quanto aos resultados clínicos, radiográficos e à taxa de complicações. MÉTODOS: Nesse estudo clínico prospectivo e randomizado, 72 pacientes com fraturas desviadas da extremidade proximal do úmero, classificadas como em 2 ou 3 partes de Neer, foram alocados para receberem osteossíntese com placa bloqueada (36 pacientes - Grupo Placa) ou haste intramedular bloqueada (36 pacientes - Grupo Haste). Os desfechos clínicos foram avaliados aos 3, 6 e 12 meses e incluíram as escalas de Constant e Murley, Universidade da Califórnia em Los Angeles modificada (UCLA), escala visual analógica de dor (EVA) e o questionário \"Disability of Arm, Shoulder and Hand\"(DASH) e a amplitude de movimento passiva. Os desfechos radiográficos consistiram na avaliação da consolidação e do ângulo cabeça-diáfise. As complicações foram avaliadas até os 12 meses e incluíram a avaliação do manguito rotador pela ultrassonografia. O desfecho primário do estudo foi a avaliação pela escala de Constant e Murley, aos 12 meses de pós-operatório. RESULTADOS: Sessenta e cinco pacientes completaram 12 meses de seguimento, sendo 32 no Grupo Haste e 33 no Grupo Placa. A escala de Constant aos 12 meses foi de 70,3 pontos para o Grupo Haste e de 71,5 pontos para o Grupo Placa (p = 0,750). A escala de Constant Relativa Individual foi de 81% para o Grupo Haste e de 85% para o Grupo Placa (p = 0,400). Também não houve diferença entre os grupos aos 3 e 6 meses para a escala de Constant. A escala EVA e o questionário DASH também não apresentaram diferença aos 3, 6 e 12 meses, assim como os resultados radiográficos. A escala UCLA apresentou diferença de 4,0 pontos aos 3 meses, com melhores resultados para o Grupo Haste (p = 0,005), mas sem diferença significante aos 6 e 12 meses. A amplitude de movimento apresentou diferença de 2,1 pontos favorável ao Grupo Haste para a rotação medial aos 6 meses (p = 0,042), sem diferença para os demais planos de movimento nos diferentes momentos de avaliação. Foram registradas 38 complicações, sendo 28 no Grupo Haste e 10 no Grupo Placa, com diferença estatística (p = 0,001). As complicações ocorreram em 18 pacientes, sendo 11 (34%) do Grupo Haste e sete (21%) do Grupo Placa, sem diferença estatística (p = 0,137). CONCLUSÕES: A osteossíntese das fraturas da extremidade proximal do úmero com placa bloqueada ou haste intramedular bloqueada produziram resultados clínicos e radiográficos semelhantes. A fixação com haste intramedular bloqueada apresentou maior taxa de complicações e reoperaçõesINTRODUCTION: Fractures of the proximal humerus are common, with an increasing incidence in the elderly and with a high impact on quality of life and shoulder function. For displaced fractures, the locking plate is the most used method of osteosynthesis. Studies have shown good clinical results with the use of locking plates, but also with the fixation with locking intramedullary nail. The aim of this study was to compare the clinical outcomes, radiographic results and the complications between these two methods in patients with displaced proximal humerus fractures. METHODS: In this prospective, randomized clinical trial, 72 patients with displaced fractures of the proximal humerus, classified as Neer 2- or 3-part, were randomly assigned to receive osteosynthesis with either locking plate (36 patients - Plate Group) or locking intramedullary nail (36 patients - Nail Group). The clinical outcomes were evaluated at 3, 6 and 12 months and included the Constant and Murley, University of California at Los Angeles (UCLA) and Disability of Arm, Shoulder and Hand (DASH) scores, visual analog scale (VAS) and the passive range of motion. Radiographic findings (consolidation and head shaft angle) and complications, which included the evaluation of rotator cuff by ultrasound, were also evaluated. The primary outcome was the Constant and Murley score at 12 months. RESULTS: Sixty-five patients completed 12 months of follow-up, 32 in the Nail Group and 33 in the Plate Group. The mean Constant score at 12 months was 70.3 points for the Nail Group and 71.5 points for the Plate Group (p = 0.750) and the mean Relative Constant score was 81% for the Nail Group and 85% points for the Plate Group (p = 0.400). There was also no difference at 3 and 6 months for the Constant score. VAS, DASH and radiographic findings also did not differ at 3, 6 and 12 months. Range of motion showed a 2.1 points difference in favor of the Nail Group for medial rotation at 6 months (p = 0.042), with no difference for the other motions at 3, 6 and 12 months. The UCLA score presented a difference of 4.0 points at 3 months, with better results for the Nail Group (p = 0.005), but no significant difference at 6 and 12 months. Thirty-eight complications were recorded, 28 in the Nail Group and 10 in the Plate Group, with significant difference (p = 0.001). Complications occurred in 18 patients, 11 (34%) of the Nail Group and seven (21%) of the Plate Group, with no significant difference (p = 0.137). CONCLUSIONS: Locking plates and locking intramedullary nail yielded similar clinical and radiographic results. Locking intramedullary nail fixation has a higher risk for complications and reoperations
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Baumueller, Eva. "Electromyogram-Biofeedback in Patients with Fibromyalgia A Randomized Controlled Trial." Diss., lmu, 2009. http://nbn-resolving.de/urn:nbn:de:bvb:19-109423.
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Chong, Shing-kan Patrick. "A randomized controlled trial for exercise prescription in general practice." Click to view the E-thesis via HKUTO, 2003. http://sunzi.lib.hku.hk/hkuto/record/B31970977.
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Hoskins, Eric William. "Edmonson-Zagreb measles vaccine : randomized controlled clinical trial in Sudan." Thesis, University of Oxford, 1993. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.386576.
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Chong, Shing-kan Patrick, and 莊承謹. "A randomized controlled trial for exercise prescription in general practice." Thesis, The University of Hong Kong (Pokfulam, Hong Kong), 2003. http://hub.hku.hk/bib/B31970977.
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Hay, Jacqueline. "Physical activity intensity and visceral adiposity: a randomized controlled trial." American Medical Association, 2012. http://hdl.handle.net/1993/16315.
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Background: Physical activity (PA) reduces visceral adipose tissue (VAT) in adults; however, the dose to reduce VAT in youth is unclear.
Objective: To examine whether high intensity PA preferentially reduces waist circumference (WC) and VAT compared to lower intensity PA.
Design: Randomized controlled trial.
Participants: Youth were 13-18yrs, overweight, with one additional risk factor for type 2 diabetes (T2DM).
Intervention: 6-months, exercising 3 times/week at a high intensity (70-85% of Heart Rate Reserve HRR), or low intensity (40-55% HRR).
Primary outcome: VAT (cm2) measured by MRI at L4-L5, and WC at the height of the iliac crest (cm).
Results: 94 Youth were randomized to either high intensity (n=30); low intensity (n=32) or control (n=32). Changes in WC and VAT were not significant across groups. A trend towards a reduction in VAT in the training groups, compared to controls was demonstrated in sub-analysis (-14.3 ± 9.6 % vs. +0.01 ± 0.4 %, p= 0.059). Peak fitness increased significantly in both the high and low intensity arms (1.3 ± 0.6 and 1.4 ± 0.6 ml/kg/min, p < 0.05).
Conclusions: Training at 55-65% HRR improves fitness by ~10%, and ~2 days/week elicits modest non-significant reductions in VAT in overweight youth.
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Castelein, Stynke. "Guided peer support groups for psychosis a randomized controlled trial /." [S.l. : [Groningen : s.n.] ; University of Groningen] [Host], 2009. http://irs.ub.rug.nl/ppn/.
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Lee, Eric B. "Telepsychotherapy for the Treatment of Trichotillomania: A Randomized Controlled Trial." DigitalCommons@USU, 2018. https://digitalcommons.usu.edu/etd/7012.
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Trichotillomania is defined as recurrent pulling of one’s hair that results in distress and negative effects on general functioning and quality of life. Estimates of trichotillomania lifetime prevalence generally range from approximately 1% to 3% and it is likely as common as disorders such as obsessive-compulsive disorder and agoraphobia. Yet, quality treatment for trichotillomania is often difficult to find as many mental health professionals are uninformed about the disorder and its treatment. Moreover, mental health services in general are inaccessible to many with estimates suggesting that 96.5 million people do not have access to adequate services. The use of telepsychology has been an effective method for disseminating treatment services for a variety of mental health conditions. However, no research has examined the effectiveness of telepsychology to treat trichotillomania.
The current study reports the results of a randomized clinical trial of Acceptance and Commitment Therapy Enhanced Behavior Therapy for the treatment of trichotillomania delivered by way of telepsychology. The study compared an active treatment condition (n = 12) to a waitlist control condition (n = 10). Results showed significant reductions in hair pulling severity from pre- to post-treatment compared to the waitlist condition.
Participants in the waitlist condition received the same treatment as participants in the treatment condition following the waitlist period. All participants were then combined to examine overall treatment effects from pre-treatment to a 12-week follow-up. The effect of treatment on hair pulling severity was still significant at follow-up, however the effect was not as strong as at post-treatment. Conversely, the effect on quality of life was maintained and even increased following post-treatment. Additional measures of psychological flexibility, perceived shame, and valued action also saw significant changes from pre-treatment to follow-up. The findings demonstrate that telepsychology is a viable option to disseminate treatment for trichotillomania. Implications, limitations, and future research directions are discussed.
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Bockrath, Margaret Feuille. "Mindfulness meditation training for spiritual struggles: A randomized controlled trial." Bowling Green State University / OhioLINK, 2015. http://rave.ohiolink.edu/etdc/view?acc_num=bgsu1445504635.
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Ide, Maiza Ritomy. ""Estudo comparativo dos efeitos de um protocolo de cinesioterapia respiratória desenvolvido em dois diferentes meios, aquático e terrestre, na função respiratória de idosos"." Universidade de São Paulo, 2004. http://www.teses.usp.br/teses/disponiveis/5/5160/tde-19102005-134451/.
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O envelhecimento populacional é uma preocupação mundial, acarretando prejuízos pulmonares. A cinesioterapia respiratória é muito utilizada, mas pouco relacionada com o meio aquático e idosos. Este estudo analisou os efeitos da cinesioterapia respiratória realizada bem dois meios - aquático e terrestre - na força muscular respiratória, flexibilidade e expansibilidade torácica de idosos. Completaram o estudo 59 sujeitos entre 60 e 65 anos, randomizados em três grupos. Dois deles realizaram exercícios respiratórios em meios aquático e terrestre. O terceiro atuou como controle. Comparando os grupos, observou-se uma melhora estatisticamente significativa da força muscular inspiratória do grupo que realizou atividades na água. As demais variáveis não sofreram alteração significativaAging of the population is a mundial concern. It causes damages in the pulmonary system. Respiratory exercises are too much used, but not so much related with the aquatic environment and aged. This study analised the effects of the respiratory exercise realized in two environments - aquatic and earth - in the respiratory muscle strength, thoracic mobility and flexibility in healthy aged. Completed the study 59 subjects between 60 and 65 years, randomized in three groups. Two of then realized respiratory exercises in earth and water and the third one acted as a control. Comparing the groups, there was a stastically significance improve in the inspiratory muscle strength in the water group. All of the other variables analised didn't change with the intervention
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Guariero, Mary Elen Salles. "Avaliação da qualidade de vida e índice de satisfação nos pacientes submetido à prostatectomia radical robótica e prostatectomia radical retropúbica: um estudo prospectivo e aleatorizado." Universidade de São Paulo, 2014. http://www.teses.usp.br/teses/disponiveis/5/5153/tde-25022015-150905/.
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INTRODUÇÃO: O câncer de próstata (CaP) é o tipo mais comum entre os tumores malignos que afetam o homem. Dentre as opções terapêuticas para o tratamento precoce do CaP, destaca-se o tratamento cirúrgico com resultados satisfatórios de até 94% de cura nos casos localizados. A ressecção cirúrgica do CaP pode ser feita por três abordagens principais: prostatectomia radical retropúbica (PRR), prostatectomia radical laparoscópica (PRL) e mais recentemente a prostatectomia radical laparoscópica robô assistida (PRAR). Uma vez que existem várias alternativas terapêuticas para esse tipo de câncer, a qualidade de vida e satisfação relacionadas à avaliação, tornam-se muito importantes nos diferentes tipos de técnicas cirúrgicas. OBJETIVO: Comparar a qualidade de vida e o índice de satisfação nos pacientes submetidos a PRR e PRAR através de um estudo prospectivo e aleatorizado. MATERIAL E MÉTODOS: Através do Sistema Único de Saúde (SUS), 200 pacientes com diagnóstico de adenocarcinoma de próstata localizado, foram selecionados de forma aleatória para participarem do estudo, sendo então encaminhados entre março de 2010 a janeiro de 2011 para o Hospital Alemão Oswaldo Cruz (HAOC) para realizar PRAR, ou para o Instituto do Câncer do Estado de São Paulo (ICESP), para a realização de PRR. Todos os pacientes foram seguidos clinicamente de maneira padrão. Utilizamos questionário SF-36 da seguinte forma: no pré-operatório e no pós-operatório de 1, 3, 6, 12, 18 e 24 meses, além de outro elaborado para avaliar a satisfação dos pacientes no pós operatório de 6, 12 e 18 meses. Os dados obtidos foram avaliados estatisticamente com nível de significância de 5%. RESULTADOS: Foram então aplicados os questionários em 200 pacientes submetidos às cirurgias (grupos homogêneos com 100 pacientes para PRR e 100 para PRAR). De acordo com os domínios de qualidade de vida, os escores médios dos aspectos físicos, aspectos emocionais e saúde mental só variaram estatisticamente entre os momentos de avaliação, sendo os grupos iguais entre si para estes domínios. De acordo com aspectos sociais houve diferença entre os grupos independente do momento de avaliação, sendo maior nos pacientes submetidos a cirurgia aberta (p = 0,016). O nível de escolaridade e a renda familiar dos pacientes que realizaram a cirurgia robótica são maiores que as dos pacientes que realizaram a cirurgia aberta (p = 0,044 e p = 0,029 respectivamente). De acordo com o grau de satisfação pós cirurgia, encontramos que os pacientes que fizeram cirurgia robótica apresentam um maior grau de satisfação com a cirurgia que aqueles submetidos a cirurgia aberta (p < 0,001). O que mais incomoda ou preocupa o paciente que realiza a cirurgia aberta é a disfunção erétil enquanto que nos pacientes que fazem à cirurgia robótica a preocupação se distribui entre cura, impotência e perda urinária. CONCLUSÃO: Demonstramos que a maioria dos aspectos de qualidade de vida são semelhantes entre os pacientes submetidos a PRR e PRAR com exceção dos aspectos sociais que foram maiores nos pacientes submetidos ao procedimento aberto, demonstramos ainda que o índice de satisfação dos pacientes é maior no procedimento robótico, entretanto a grande maioria dos pacientes realizariam o mesmo tratamento quando questionadosINTRODUCTION: Prostate cancer (PCa) is the most common malignant tumors that affect man. Among the treatment options for early treatment of PCa, stands out the surgical treatment with satisfactory results, achieving cure results of up to 94% in localized cases. Surgical resection of PCa can be done through three main approaches, which are radical retropubic prostatectomy (RRP), laparoscopic radical prostatectomy (LRP) and more recently robotic-assisted laparoscopic radical prostatectomy (RALRP). Since there are several alternative therapies for this cancer, quality of life and satisfaction related to the evaluation of different types of surgery became very important. OBJECTIVE: Evaluate the two most widely used techniques: RRP and RALRP through a prospective randomized study, checking the satisfaction and quality of life in patients who have undergone these treatments. MATERIAL AND METHODS: The choice of surgical approach of the patient occurred randomly and the patients were selected through the Unified Health System (SUS) and sent to the Oswaldo Cruz Hospital (HAOC) for RALRP (robotic-assisted laparoscopic radical prostatectomy) or sent to the Cancer Institute of the State of São Paulo (ICESP) for RRP (radical retropubic prostatectomy), between March 2010 and January 2011. All patients were followed clinically in a standard way through a questionnaire, SF-36 and a questionnaire to evaluate their satisfaction. It was also verified the level of regret in post-surgery within 1, 3, 6, 12 and 24 months and the level of satisfaction was verified at 6 12 and 18 months post-surgery. The data were statistically evaluated with a significance level of 5%. RESULTS: We then applied the questionnaires in 200 patients who underwent surgery, and 100 patients who underwent RRP and 100 patients who underwent RALRP. The groups were quite homogeneous. According to the domains of quality of life, the average scores of physical, emotional and mental health only varied significantly among time points of evaluation, and the groups were equal to each other for these domains. According to the social aspects there were differences between the groups regardless of the time of evaluation, being higher in patients who underwent open surgery (p = 0.016). The education level and family income of patients who underwent robotic surgery are higher than of patients who underwent open surgery (p = 0.044 and p = 0.029 respectively). According to the level of satisfaction post-surgery, we realized that robotic surgery patients have a higher level of satisfaction about the surgery than those undergone open surgery (p < 0.001). The most signicant thing that bothers or worries the open surgery patients is sexual impotence while in robotic surgery patients, the concern is distributed among cure, impotence and urinary incontinence. CONCLUSION: We demonstrated that most aspects of quality of life are similar among patients undergoing RRP and RALRP except social aspects that were higher in patients undergone open surgery. We further demonstrated that the rate of satisfaction is higher in the robotic procedure patients. However, when questioned, the vast majority of patients would do the same treatment
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Hill, Ryan M. "Open Trial and Pilot Randomized Controlled Trial of a Novel Program to Reduce Perceived Burdensomeness." FIU Digital Commons, 2015. http://digitalcommons.fiu.edu/etd/2243.
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To date, suicide prevention programs for adolescents have not demonstrated sustained reductions in suicide-related behaviors and further program development is called for, particularly for the prevention of non-clinical suicide risk. This research utilizes the Interpersonal-Psychological Theory of Suicide in the development of the LEAP Program, a novel, web-based suicide prevention program targeting reductions in cognitions of perceived burdensomeness. An open trial of the program was conducted to examine the feasibility of the study protocol, generate feedback regarding the LEAP program modules, and refine the program modules. A pilot randomized controlled trial of the program was also conducted to examine participant satisfaction with the intervention and adherence to the intervention protocol, to test the research protocol, and to provide initial evidence for its efficacy. The open trial consisted of eight adolescents who completed a baseline assessment, received the LEAP intervention, and completed a post-intervention assessment. Results indicated sufficient feasibility of the study protocol and acceptability of the LEAP intervention. The pilot randomized controlled trial consisted of 80 adolescents who were randomly assigned to either the LEAP intervention or a treatment-as-usual control condition. Results indicated that those who completed the LEAP intervention showed significantly reduced perceived burdensomeness scores at post-intervention, as compared to those in the control condition. In addition, those who completed the intervention reported significantly reduced perceived burdensomeness, thwarted belongingness, and depressive symptom scores at follow-up, as compared to those in the control condition. No significant reductions in suicidal ideation were noted for those who completed the intervention, as compared to those in the control condition. Strengths and weaknesses of the present studies are discussed, and considerations for future research directions are noted.
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Buttner, Melissa Mercedes. "Efficacy of Yoga for Depressed Postpartum Women: a Randomized Controlled Trial." Diss., University of Iowa, 2013. https://ir.uiowa.edu/etd/4825.
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Postpartum depression (PPD) is a significant public health issue. Up to 20% of women are affected by depression following childbirth. PPD is associated with anxiety, poor adjustment and health-related quality of life (HRQOL), and may lead to a woman's personal suffering, conflict with family members (especially in the relationship with partner) and developmental delays in children. Given the high prevalence of PPD and deleterious effects on both women and their families, adequate treatment is critical. While existing PPD treatments have strong efficacy data, the treatment literature suggests that many depressed postpartum women either do not receive treatment or receive suboptimal care. Further, barriers to care including medication side effects for breastfeeding women, stigma, and treatment preferences influence treatment decision-making. Thus, it may be worthwhile to examine the efficacy of a complementary and alternative medicine (CAM) treatment option for PPD that is associated with minimal risk and consistent with maternal preferences.
The current investigation examined the efficacy of a Gentle Vinyasa Flow yoga intervention for PPD. Fifty-seven postpartum women with a score of ≥12 on the Hamilton Depression Rating Scale (HDRS) were randomly assigned to 1 of 2 groups − yoga n = 28) or wait-list control (WLC) ((italic)n(/italic) = 29). The yoga intervention lasted 8 weeks, and consisted of 16 classes taught by a certified yoga instructor in a studio and the recommendation to practice once a week at home with the use of a DVD that included a 30 minute yoga sequence. The primary outcome, depression, was assessed using the clinician-rated HDRS and self-report measures. The HDRS was administered over the telephone by blinded raters at baseline and after 2, 4, 6, and 8 weeks of treatment. Secondary outcomes were anxiety, postpartum adjustment, and HRQOL, with exploratory outcomes including mindfulness and physical activity. These outcomes were assessed using self-report measures completed on the same schedule as that for the HDRS. Growth curve modeling was used to test the hypotheses that women in the yoga group would experience a significantly greater rate of change over the course of the 8-week intervention on primary and secondary outcome measures, relative to the WLC group. As predicted, controlling for age and social anxiety at baseline, women in the yoga group experienced a greater rate of change in depression and well-being scores over the course of the 8-week intervention. The yoga group also experienced a significantly greater rate of improvement on scores of anxiety, postpartum adjustment, HRQOL, and mindfulness over the 8-week intervention, relative to the control group.
These findings support yoga as a promising CAM intervention for PPD; large-scale replication studies are warranted. The findings also shed light on potential mediator and intervention-relevant variables for future research. Yoga is an acceptable and low-risk treatment option that may have broader clinical implications for the PPD treatment literature, and the field of CAM more generally.
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Baik, Kyoung deok. "Evaluating Acceptance and Commitment Therapy for Insomnia: A Randomized Controlled Trial." Bowling Green State University / OhioLINK, 2015. http://rave.ohiolink.edu/etdc/view?acc_num=bgsu1435680293.
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Ferreira, Christiane Alves [UNIFESP]. "Validade da produção científica de acesso aberto indexada na base de dados Lilacs em odontologia." Universidade Federal de São Paulo (UNIFESP), 2010. http://repositorio.unifesp.br/handle/11600/21836.
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Previous issue date: 2010Objetivos: Realizar uma análise metodológica da área de odontologia quanto ao risco de viés de ensaios controlados randomizados (ECR) de acesso aberto, disponibilizados na base de dados Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde), avaliar a potencial contribuição da Lilacs como fonte de estudos primários para revisões sistemáticas da literatura e avaliar possível associação entre a base Qualis, tipo de estudo e risco de viés. Material e Métodos: Foram selecionados 40 periódicos de acesso aberto da base Lilacs. Uma busca manual página a página foi conduzida para identificar os artigos publicados, de acordo com o tipo de estudo, durante um período de seis anos. A classificação dos estudos foi realizada por revisores independentes com a confiabilidade avaliada por estatística Kappa. Os ECR identificados foram separados para a avaliação do risco de viés. Foram coletados dados sobre: geração da seqüência de alocação, sigilo da alocação, cegamento, dados de desfechos incompletos, número de dimensões de baixo risco de viés, país e Qualis. As associações foram avaliadas pelos testes de Kruskal-Wallis, Mann Withney e Kendal tau, correlação de Sperman e análise de regressão. Resultados: A pesquisa manual recuperou 4879 artigos com predominância de estudos com baixo nível de evidência (92%). Estudos com alto nível de evidência para avaliação de intervenções representavam apenas 1,94% dos artigos indexados. Estudos epidemiológicos como Caso-Controle e Coorte eram apenas 1,41%. O Brasil representou 72% do total de publicações, entretanto, 64,42% dos estudos utilizaram projetos de pesquisa com baixo nível de evidência. Dos 78 estudos classificados, somente 10 eram verdadeiros ECR e, destes, somente um único estudo era de baixo risco de viés. O item mais frequentemente nos ECR avaliados foi cegamento. A base Qualis não estava associada à hierarquia de evidência e nem às dimensões de risco de viés. Conclusão: O conjunto de estudos em odontologia indexados na base Lilacs se constitui em um corpo de evidência muito limitado para fornecer estudos primários elegíveis com alto nível de evidência para autores de revisões sistemáticas, para clínicos e gestores sobre intervenções, prognóstico ou etiologia em odontologia.
Objectives: To conduct a methodological analysis of the area of dentistry on the risk of bias in randomized controlled trials (RCT) of open access, available in the database Lilacs (Latin American and Caribbean Health Sciences), to assess the potential contribution Lilacs as the source of primary studies for systematic reviews and and evaluate possible association between the base and Qualis study type and risk of bias. Methods: We selected 40 open access journals of the Lilacs database. A handsearch page page has been conducted to identify published articles, according to the type of study, over a period of six years. The classification of studies was conducted by independent reviewers with reliability assessed by Kappa statistic. RCTs identified were separated to assess the risk of bias. We collected data on: generation of allocation sequence, allocation concealment, blinding, incomplete outcome data, number of dimensions of low risk of bias, country and Qualis. Associations were evaluated by Kruskal-Wallis, Mann Whitney and Kendal tau, Spearman correlations and regression analysis. Results: The handsearch retrieved 4879 articles with predominance of studies with a low level of evidence (92%). Studies with a high level of evidence for evaluation of interventions represented only 1.94% of the articles indexed. Epidemiological studies and case-control and cohort were only 1.41%. Brazil has accounted for 72% of all publications, however, 64.42% of the studies used research projects with low level of evidence. Of the 78 studies classified, only 10 were true RCT, and of these only one study was a low risk of bias. The item most often evaluated in the RCT was blinding. The base which was not associated with the hierarchy of evidence and not to the dimensions of risk of bias. Conclusion: The set of studies in dentistry indexed in Lilacs constitutes a very limited body of evidence to provide eligible primary studies with high evidence to authors of systematic reviews to clinicians and managers about operations, prognosis or etiology in dentistry.
BV UNIFESP: Teses e dissertações
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Brescia, Marília D'Elboux Guimarães. "Estudo prospectivo aleatorizado comparando a eficiência clínica dos métodos convencional ou piggyback na drenagem venosa do fígado transplantado." Universidade de São Paulo, 2007. http://www.teses.usp.br/teses/disponiveis/5/5160/tde-24102007-125106/.
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O objetivo desta pesquisa é comparar a eficiência clínica dos métodos convencional ou piggyback de transplante de fígado (Tx) na reconstrução do efluxo venoso do enxerto. Adicionalmente, pretende-se comparar a eficácia da drenagem venosa do enxerto hepático em diferentes modalidades do método piggyback. Foram estudados 32 pacientes submetidos a Tx pelo método convencional (n=15) ou piggyback (n=17). A pressão da veia hepática livre (PVHL) foi medida por catéter introduzido na veia hepática direita (VHD) do enxerto e a pressão venosa central (PVC) por catéter de Swan-Ganz. As medidas de pressão foram realizadas após a revascularização do enxerto. Gradiente PVHL-PVC superior a 3 mm Hg foi encontrado em 26,7% (4/15) no grupo convencional e 17,6% (3/17) no grupo piggyback (p=0,678). A mediana do gradiente PVC-PVHL foi de 2 mm Hg (0-8 mm Hg) no grupo convencional e 3 mm Hg (0-7 mm Hg) no piggyback (p=0,734). A creatinina sérica (Cr) foi medida no pré-operatório, do 1º ao 7º dia pós-operatório (PO) e no 14º, 21º e 28º PO. A Cr global pós-operatória, calculada pela área sob a curva da Cr vs tempo, foi significativamente maior no grupo convencional (2,04 ± 0,89 vs. 1,41 ± 0,44 mg/dL; p=0,02). Não houve diferença estatisticamente significante entre os grupos quanto à ocorrência de insuficiência renal aguda (p=0,120), definida como Cr maior ou igual a 2,0 mg/dL, quanto ao desenvolvimento de ascite maciça (p=1,000) e em relação à sobrevida dos pacientes (p=0,316). O gradiente PVHL-PVC foi significativamente menor nos casos em que o óstio da VHD é utilizado para reconstrução da via de drenagem venosa no Tx piggyback (1,4 ± 1,4 mm Hg vs. 3,9 ± 1,7 mm Hg; p=0,005). Conclui-se que pacientes submetidos a Tx pelos métodos convencional e piggyback apresentam resultados semelhantes em relação à drenagem venosa do enxerto, ao desenvolvimento de ascite e à sobrevida. Os valores de Cr no PO imediato são significantemente maiores no método convencional. Nos pacientes submetidos a Tx pelo método piggyback, o gradiente PVHL-PVC é menor nos casos em que o óstio da VHD do receptor é incluído para implantação da VCI do enxerto.The aim of this study is to compare the clinical efficiency of hepatic venous outflow reconstruction in conventional and piggyback method of liver transplantation (LTx). The efficacy of the different types of reconstruction of venous drainage in the piggyback liver transplantation was analyzed by a second purpose. Thirty two patients submitted to LTx by conventional method (n=15) or piggyback method (n=17) were studied. Free hepatic venous pressure (FHVP) was measured using a catheter introduced in right hepatic vein (RHV). Central venous pressure (CVP) was obtained through Swan-Ganz catheter. Pressure measurements were performed after graft reperfusion. A FHVP-CVP gradient higher than 3 mm Hg was observed in 26.7% (4/15) of the conventional and in 17.6% (3/17) of the piggyback patients (p=0.678). Median FHVP-CPV gradient value was 2 mm Hg (0-8 mm Hg) in the conventional and 3 mm Hg (0-7 mm Hg) in the piggyback group (p=0.734). Serum creatinine (Cr) was measured on postoperative days 1 to 7, 14, 21 and 28. Postoperative overall Cr, calculated by area under the curve of Cr vs. time, was significantly higher in conventional group (2.04 ± 0.89 vs. 1.41 ± 0.44 mg/dL; p=0.02). There is no significant difference between the groups regarding occurrence of acute renal failure (p=0,120), defined by Cr maior ou igual a 2,0 mg/dL, development of massive ascites (p=1,000) and patient survival (p=0,316). In piggyback LTx patients, FHVP-CVP gradient was significantly lower when the ostium of the RHV of the recipient is used for venous drainage reconstruction (1.4 ± 1.4 mm Hg vs. 3.9 ± 1.7 mm Hg; p=0.005). In conclusion, patients submitted to conventional or piggyback method of LTx have similar results regarding venous outflow, development of ascites and survival. The postoperative Cr values are significantly higher in conventional method. Patients submitted to piggyback LTx present a lower FHVP-CVP gradient when the ostium of the RHV of the recipient is included for implantation of the graft inferior vena cava.
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Gebreselassie, Hailemichael. "Iron supplementation and malaria infection : results of a randomized controlled field trial." Thesis, McGill University, 1996. http://digitool.Library.McGill.CA:80/R/?func=dbin-jump-full&object_id=42040.
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Iron deficiency anaemia is associated with several ill-health effects. Its treatment and/or control with iron preparations in malaria endemic areas has, however, been implicated to increase host susceptibility to malaria infection. Scientific evidence accumulated to date remains equivocal about the presence of this increased susceptibility. The present work was planned to address the existing controversy by assessing the effect of oral iron supplementation on host susceptibility to malaria infection.A randomized, double-blind, placebo-controlled field trial of oral ferrous sulphate supplementation in schoolchildren 5 to 14 years of age was carried out in northwest Ethiopia where transmission of malaria is high. A total of 500 school children, all with mild-to-moderate iron deficiency, were randomly assigned to receive either ferrous sulphate (60 mg elemental iron per day) or a look-alike placebo, over a period of 12 weeks. Follow-up continued for 24 weeks post-randomization.
Children who received iron supplementation tended to develop more clinical attacks of malaria than those children who received placebo, although the difference between the groups was not statistically significant, either during the initial 12 week supplementation period (RR = 1.59; 95% CI: 0.92-2.75) or during the 24 weeks of follow-up (RR = 1.45; 95% CI: 0.95-2.20). Similarly, a trend of increased risk of malaria infection (parasitemia) was noted in the iron-supplemented group over the 24 week follow-up period (RR = 1.22; 95% CI: 0.98-1.52). No difference in any other outcome measure (spleen rate, average enlarged spleen index, and parasite density index) was observed between the groups either during the 12 weeks of supplementation or the 24 weeks of follow-up.
This study suggests that iron supplementation, in areas where iron deficiency and malaria co-occur, may enhance host susceptibility to malaria infection. Thus, approaches to control or prevent iron deficiency anaemia in malaria endemic areas should be integrated with malaria control activities in order to minimize the unintended effects of malaria infection while providing the greatest benefit.
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Gebreselassie, Hailemichael. "Iron supplementation and malaria infection, results of a randomized controlled field trial." Thesis, National Library of Canada = Bibliothèque nationale du Canada, 1997. http://www.collectionscanada.ca/obj/s4/f2/dsk2/ftp03/NQ29944.pdf.
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Rush, Janet Patricia Brown. "A randomized controlled trial of the effects of the bath in labour." Thesis, National Library of Canada = Bibliothèque nationale du Canada, 1999. http://www.collectionscanada.ca/obj/s4/f2/dsk1/tape9/PQDD_0020/NQ45760.pdf.
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