Auswahl der wissenschaftlichen Literatur zum Thema „Randomised clinical trial (RCT)“
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Zeitschriftenartikel zum Thema "Randomised clinical trial (RCT)"
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Chen, Yu, und Ruiqing Yan. „From registration, protocol to report: are COVID-19-related RCTs in mainland China consistent? A systematic review of clinical trial registry and literature“. BMJ Open 12, Nr. 7 (Juli 2022): e058070. http://dx.doi.org/10.1136/bmjopen-2021-058070.
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ObjectiveTo provide a comprehensive review of registered COVID-19-related randomised controlled trials (RCTs) in mainland China and evaluate the transparency of reporting through comparison of registrations, protocols and full reports.DesignSystematic review of trial registrations and publications.Data sourcesInternational Clinical Trials Registry Platform, Chinese Clinical Trial Registry, ClinicalTrials.gov, the ISRCTN registry and EU Clinical Trial Register were accessed on 1 February 2022. Publications were searched in PubMed, Embase, Cochrane Library, Google Scholar, CNKI.net and Wanfangdata from 10 February 2022 to 12 February 2022.Eligibility criteriaEligible trials were COVID-19 related RCTs carried out in mainland China. Observational studies, non-randomised trials and single-arm trials were excluded.Data extraction and synthesisTwo reviewers independently extracted data from registrations, publications and performed risk of bias assessment for trial reports. Information provided by registrations and publications was compared. The findings were summarised with descriptive statistics.ResultsThe number of eligible studies was 415. From these studies 20 protocols and 77 RCT reports were published. Seven trials published both protocol and RCT full report. Between registrations and publications, discrepancy or omission was found in sample size (7, 35.0% for protocols and 47, 61.0% for reports, same below), trial setting (13, 65.0% and 43, 55.8%), inclusion criteria (12, 60.0% and 57, 74.0%), exclusion criteria (10, 50.0% and 54, 70.1%), masking method (9, 45.0% and 35, 45.5%) and primary outcome or time frame of primary outcome measurement (14, 70.0% and 51, 66.2%). Between protocols and full reports, 5 (71.4%) reports had discrepancy in primary outcome or time frame of primary outcome measurement.ConclusionsDiscrepancy among registrations, protocols and reports revealed compromised transparency in reporting of COVID-19-related RCTs in mainland China. The importance of trial registration should be further emphasised to enhance transparent RCT reporting.
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Zaghloul, Hadeel, Odette Chagoury, Sara Elhadad, Salma Hayder Ahmed, Noor Suleiman, Abdulla Al Naama, Katie El Nahas et al. „Clinical and metabolic characteristics of the Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I) randomised clinical trial cohort“. BMJ Open 10, Nr. 12 (Dezember 2020): e041386. http://dx.doi.org/10.1136/bmjopen-2020-041386.
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ObjectivesDiabetes Intervention Accentuating Diet and Enhancing Metabolism-I (DIADEM-I) is the first randomised controlled trial (RCT) in the Middle East and North Africa (MENA) region testing the effectiveness of an intensive lifestyle intervention (ILI) for weight loss and diabetes remission. We report on the recruitment process and baseline characteristics of the DIADEM-I cohort based on origin (Middle East vs North Africa), and waist circumference.DesignDIADEM-I is an open-label randomised, controlled, parallel group RCT recruiting young individuals (18–50 years) with early type 2 diabetes (≤3 years since diagnosis) originating from MENA. Individuals from primary care were randomised to usual medical care or ILI (total dietary replacement phase using meal replacement products, followed by staged food reintroduction and physical activity support). The primary outcome is weight loss at 12 months. Other outcomes are glycaemic control and diabetes remission.SettingPrimary care, Qatar.Participants147 (73% men) randomised within DIADEM-I who were included in the final trial data analysis.Outcome measuresRecruitment metrics, and baseline clinical and metabolic characteristics.ResultsOf 1498 people prescreened, 267 (18%) were invited for screening and 209 (78%) consented. 173 (83%) were eligible. 15 (7%) withdrew before randomisation and the remaining 158 were randomised. Mean age was 42.1 (SD 5.6) years and mean body mass index was: 36.3 (5.5) kg/m2 (women) and 34.4 (5.4) kg/m2 (men). Mean diabetes duration was 1.8 (1.0) years and mean glycosylated haemoglobin (HbA1c) was 7.0% (1.30) (52.5 mmol/mol (SD 14.3)). Participants originated from 13 countries. Those from North Africa reported greater physical activity and had lower family history of diabetes. 90% of subjects were taking diabetes medications and 31% antihypertensives. Those with greater waist circumference had significantly higher insulin resistance and lower quality of life.ConclusionRecruitment of participants originating from the MENA region into the RCT was successful, and study participation was readily accepted. While DIADEM-I participants originated from 13 countries, there were few baseline differences amongst participants from Middle East versus North Africa, supporting generalisability of RCT results.Trial registration numberISRCTN20754766; NCT03225339
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Planas-Cerezales, Lurdes, Laura Fabbri und Laurence Pearmain. „Add-on therapy for pulmonary fibrosis, a forthcoming era with implications for practice: the BI 101550 and RELIEF trials“. Breathe 19, Nr. 3 (September 2023): 230090. http://dx.doi.org/10.1183/20734735.0090-2023.
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The therapeutic landscape for idiopathic pulmonary fibrosis (IPF) and progressive fibrosing interstitial lung disease (PFILD) is increasingly complex, with add-on antifibrotic options now in clinical trials, or available for patients progressing on first-line therapy in both conditions. Here, we review two recent trials of potential add-on therapeutic options, the BI 101550 and RELIEF trials. BI 101550 was a phase 2 randomised control trial (RCT) of a novel phosphodiesterase-4 inhibitor in patients with IPF, with a primary end-point of change in forced vital capacity (ΔFVC) (in mL) at 12 weeks. The RELIEF trial was a phase 2 RCT in patients with PFILD, with a primary end-point of ΔFVC (absolute % predicted) over 48 weeks. Whilst the BI 101550 and RELIEF trials showed positive results in their primary end-points, the strengths and weaknesses of both trials are discussed with importance for their interpretation and clinical impact. We review current clinical practice in IPF and PFILD and place the BI101550 and RELIEF trial results in context, highlighting advances and problems with antifibrotic therapies.Commentary on:Richeldi L,et al.Trial of a preferential phosphodiesterase 4B inhibitor for idiopathic pulmonary fibrosis. N Engl J Med 2022; 386: 2178–2187.Behr J,et al.Pirfenidone in patients with progressive fibrotic interstitial lung diseases other than idiopathic pulmonary fibrosis (RELIEF): a double-blind, randomised, placebo-controlled, phase 2b trial. Lancet Respir Med 2021; 9: 476–486.
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Keogan, Sheila, Shasha Li und Luke Clancy. „Allen Carr’s Easyway to Stop Smoking - A randomised clinical trial“. Tobacco Control 28, Nr. 4 (25.10.2018): 414–19. http://dx.doi.org/10.1136/tobaccocontrol-2018-054243.
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Objective To determine if Allen Carr’s Easyway to Stop Smoking (AC) was superior to Quit.ie in a randomised clinical trial (RCT). Setting Single centre, open RCT, general population based. Participants 300 adult smokers, 18 years plus, minimum 5 cigarettes daily, and English speaking. AC, 151 (females 44.4%) and Quit.ie, 149 (females 45.6%), mean age 44 years. outcomes for all 300 were analysed (intention-to-treat). Recruited through advertisement from July 2015 to February 2016. Intervention Randomly assigned to AC (n=151) and Quit.ie (n=149), matched for age, sex and education. Block randomisation, enrolment and follow-up at 1, 3, 6 and 12 months. Primary aim was to determine if AC had higher quit rates than Quit.ie service at 3 months. Secondary aims: quit rates at 1, 6 and 12 months and analysis of associated factors including weight. AC consisted of a 5-hour seminar, in a group setting. Quit.ie is an online portal for smoking cessation. Results AC had higher quit rates at 1, 3, 6 and 12 months. AC: 38%, (n=57), 27% (n=40), 23% (n=35), 22% (n=33) vs Quit.ie: 20% (n=30), 15% (n=22), 15% (n=23), 11% (n=17), respectively (all p values <0.05). Logistic regression AC vs Quit.ie, OR 2.26 (95% CI 1.22 to 4.21) p value=0.01. Weight gain 3.8 kg in AC vs 1.8 kg in Quit.ie (p value <0.05). Conclusions All AC quit rates were superior to Quit.ie, outcomes were comparable with established interventions. Trial registration number NCT12951013. Recruitment July 2015–February 2016.
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Jenkins, Valerie A., und Lesley J. Fallowfield. „For the Benefit of Others: Reasons Why Women with Breast Cancer Participate in RCTs“. Breast Care 10, Nr. 2 (2015): 88–93. http://dx.doi.org/10.1159/000376563.
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Background: Appreciation of the barriers and drivers affecting enrolment in randomised clinical trials (RCTs) is important for future trial design, communication and information provision. Methods: As part of an intervention to facilitate UK multidisciplinary team communication about RCTs, women with breast cancer who discussed trials with doctors or research nurses completed questionnaires examining i) clarity of trial information and ii) reasons for their trial decision. Results: 152 women completed the questionnaires; 113/152 (74%) consented to RCT enrolment. Patients' satisfaction with communication about the trial information was very good, irrespective of participation decisions. Acceptors' and decliners' responses to 9/16 statements concerning decisions about trial participation differed significantly. ‘Wanting to help with doctor's research' influenced 100% acceptors compared to 57% of decliners (p < 0.001). Decliners were more likely to be ‘worried about randomisation' (20 vs. 39%; p < 0.035) and to ‘want doctor to choose treatment rather than be randomised' (31 vs. 53%; p < 0.031). Primary reason for trial acceptance was altruism; ‘I feel that others with my illness will benefit from the results of the trial', 58/108 (54%). Conclusion: A majority of women accepted RCT entry citing altruistic motivations as the primary driver for participation. Trial design and setting (metastatic or adjuvant) had little impact on participation.
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Hamilton, E. P., G. H. Lyman, S. Kim und J. Peppercorn. „Availability of experimental therapy outside of randomized clinical trials in oncology“. Journal of Clinical Oncology 27, Nr. 15_suppl (20.05.2009): 6539. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.6539.
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6539 Background: Investigational cancer therapies may be available outside of trials, or “off protocol” (OPRx), with implications for patient safety, trial accrual, and access to care. Previous studies suggest OPRx is prevalent in oncology, but there is little consensus on when it should or should not be considered. We evaluated the scope and impact of OPRx through assessment of availability of the experimental arms of recent randomized trials (RCT), and evaluation of study outcomes and accrual. Methods: We conducted a Medline search to identify all English language phase III RCT of medical interventions in oncology over a 2-year period ending April 17, 2008. We determined availability of experimental interventions based on FDA approval for any indication. We limited assessment of accrual (time to trial completion, patients/month) to studies with US sites. Significance of results was assessed by Fisher's exact test and unpaired t-test. Results: We identified 172 eligible RCT. The majority of RCT (108, 63%) evaluated drugs that were available OPRx at trial initiation, while an additional 19 (11%) trial drugs became available during the trial. 64 (55%) were available due to FDA approval for the same cancer in a different setting, 40 (35%) for a different cancer, and 12 (10%) for a non-cancer indication. 25% of trials were conducted at only US sites, 15% included US and international sites, and 60% were international only. Trials in which OPRx was available had slower time to completion compared to trials in which OPRx was unavailable (48 vs. 26 months, p = 0.04) and a trend towards slower accrual (14.0 vs. 40.7 patients/month, p = 0.06). For the majority of RCT (66%), there was at least one grade 3/4 toxicity that was greater in the experimental arm, for 47% the experimental interventions proved superior for 1 major outcome, and 27% demonstrated improvement in overall survival. These outcomes did not vary based on availability OPRx. Conclusions: The majority of recent oncology trials involve experimental regimens that are available outside of a trial. The safety and efficacy of novel interventions must be determined by trials but availability of OPRX may impact accrual. Guidelines are needed for OPRx in oncology. No significant financial relationships to disclose.
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Chen, Stephanie C., Cheryl McCullumsmith und Scott Y. H. Kim. „Disclosing the potential impact of placebo controls in antidepressant trials“. BJPsych Open 1, Nr. 1 (Juni 2015): 1–5. http://dx.doi.org/10.1192/bjpo.bp.115.000109.
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BackgroundAlthough placebo-control clinical trials that withhold effective treatments can be permissible, how best to inform participants of the placebo design has received little attention.AimsTo determine the effect of disclosing quantitative outcome estimates of individual treatment v. entering placebo-control randomised control trial (RCT) on willingness to enrol in such an RCT.MethodWe randomised 278 adult patients at a depression clinic to receive standard disclosure (n = 129) or enhanced (n = 149) quantitative outcome estimates (based on decision analysis) of individual treatment v. RCT, and assessed their willingness to enrol in the RCT.ResultsA greater proportion of those in the standard arm preferred enrolling in RCT (41.3% v. 23.8%, P = 0.002). Those in the standard arm preferred RCT more for direct benefit than altruism reasons, whereas the opposite was true in the enhanced arm.ConclusionsDisclosing the quantitative outcome implications of placebos may select for fewer but more altruistic participants.
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Alli, Babatunde Y., Sreenath Madathil, Simon D. Tran und Belinda Nicolau. „Protocol: carrageenan for the prevention of oral HPV infection – a feasibility randomised clinical trial“. BMJ Open 13, Nr. 7 (Juli 2023): e074498. http://dx.doi.org/10.1136/bmjopen-2023-074498.
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IntroductionHead and neck cancers (HNCs) are a significant health burden worldwide. Oral human papillomavirus (HPV) infection is a major risk factor for HNCs. Unfortunately, currently available prophylactic vaccines have limited coverage and potential for HPV type replacement. Carrageenan, a natural product extracted from marine red algae, has demonstrated potency as an HPV inhibitor and could offer a potential alternative to prevent HPV-related diseases, including oral HPV infection. However, there is a lack of clinical studies on the effect of carrageenan on oral HPV infections. As a first step to address this gap, we propose a randomised controlled trial (RCT) to evaluate the feasibility of conducting a larger multicentric RCT to investigate the effect of a carrageenan mouthwash on oral HPV infection.Methods and analysisWe will conduct a placebo-controlled triple-blinded feasibility RCT with two parallel arms, each arm consisting of 20 participants. Participants will complete a single in-person visit at baseline and conduct biweekly follow-ups from home by completing a web-based questionnaire and sending saliva self-samples via mail. During the 6-month period trial, participants will gargle with the mouthwash morning and night, and around sexual activities. The study will evaluate several factors including recruitment and retention rates, the feasibility of data collection procedures, compliance with study procedures, acceptability of RCT procedures and intervention and safety data on carrageenan use in the oral cavity. We will estimate the standard deviation of outcome measures, including time to the incidence of oral HPV infection and time to clearance of prevalent oral HPV infection. The trial primary outcome is whether to proceed to a definitive trial based on prespecified progression criteria.Ethics and disseminationThe protocol was approved by the McGill University institutional review board. Study results will be presented at scientific conferences and published in academic journals.Trial registration numberNCT05746988.
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Kho, Michelle E., Alexander J. Molloy, France J. Clarke, Julie C. Reid, Margaret S. Herridge, Timothy Karachi, Bram Rochwerg et al. „Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients“. BMJ Open Respiratory Research 6, Nr. 1 (Februar 2019): e000383. http://dx.doi.org/10.1136/bmjresp-2018-000383.
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IntroductionAcute rehabilitation in critically ill patients can improve post-intensive care unit (post-ICU) physical function. In-bed cycling early in a patient’s ICU stay is a promising intervention. The objective of this study was to determine the feasibility of recruitment, intervention delivery and retention in a multi centre randomised clinical trial (RCT) of early in-bed cycling with mechanically ventilated (MV) patients.MethodsWe conducted a pilot RCT conducted in seven Canadian medical-surgical ICUs. We enrolled adults who could ambulate independently before ICU admission, within the first 4 days of invasive MV and first 7 days of ICU admission. Following informed consent, patients underwent concealed randomisation to either 30 min/day of in-bed cycling and routine physiotherapy (Cycling) or routine physiotherapy alone (Routine) for 5 days/week, until ICU discharge. Our feasibility outcome targets included: accrual of 1–2 patients/month/site; >80% cycling protocol delivery; >80% outcomes measured and >80% blinded outcome measures at hospital discharge. We report ascertainment rates for our primary outcome for the main trial (Physical Function ICU Test-scored (PFIT-s) at hospital discharge).ResultsBetween 3/2015 and 6/2016, we randomised 66 patients (36 Cycling, 30 Routine). Our consent rate was 84.6 % (66/78). Patient accrual was (mean (SD)) 1.1 (0.3) patients/month/site. Cycling occurred in 79.3% (146/184) of eligible sessions, with a median (IQR) session duration of 30.5 (30.0, 30.7) min. We recorded 43 (97.7%) PFIT-s scores at hospital discharge and 37 (86.0%) of these assessments were blinded.DiscussionOur pilot RCT suggests that a future multicentre RCT of early in-bed cycling for MV patients in the ICU is feasible.Trial registration numberNCT02377830.
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Watts, Stacey, Yogesh Apte, Thomas Holland, April Hatt, Alison Craswell, Frances Lin, Alexis Tabah et al. „Randomised, controlled, feasibility trial comparing vasopressor infusion administered via peripheral cannula versus central venous catheter for critically ill adults: A study protocol“. PLOS ONE 19, Nr. 5 (13.05.2024): e0295347. http://dx.doi.org/10.1371/journal.pone.0295347.
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Background When clinicians need to administer a vasopressor infusion, they are faced with the choice of administration via either peripheral intravenous catheter (PIVC) or central venous catheter (CVC). Vasopressor infusions have traditionally been administered via central venous catheters (CVC) rather than Peripheral Intra Venous Catheters (PIVC), primarily due to concerns of extravasation and resultant tissue injury. This practice is not guided by contemporary randomised controlled trial (RCT) evidence. Observational data suggests safety of vasopressor infusion via PIVC. To address this evidence gap, we have designed the “Vasopressors Infused via Peripheral or Central Access” (VIPCA) RCT. Methods The VIPCA trial is a single-centre, feasibility, parallel-group RCT. Eligible critically ill patients requiring a vasopressor infusion will be identified by emergency department (ED) or intensive care unit (ICU) staff and randomised to receive vasopressor infusion via either PIVC or CVC. Primary outcome is feasibility, a composite of recruitment rate, proportion of eligible patients randomised, protocol fidelity, retention and missing data. Primary clinical outcome is days alive and out of hospital up to day-30. Secondary outcomes will include safety and other clinical outcomes, and process and cost measures. Specific aspects of safety related to vasopressor infusions such as extravasation, leakage, device failure, tissue injury and infection will be assessed. Discussion VIPCA is a feasibility RCT whose outcomes will inform the feasibility and design of a multicentre Phase-3 trial comparing routes of vasopressor delivery. The exploratory economic analysis will provide input data for the full health economic analysis which will accompany any future Phase-3 RCT.
Dissertationen zum Thema "Randomised clinical trial (RCT)"
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Anjara, Sabrina Gabrielle. „A study of two models of primary mental health care provisions in Yogyakarta, Indonesia“. Thesis, University of Cambridge, 2019. https://www.repository.cam.ac.uk/handle/1810/289729.
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Background The World Health Organization (WHO) defines health as a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity. Despite its importance, mental health provisions are often limited. In 2015, Indonesia had only 773 psychiatrists for 250 million residents. This shortage of specialist mental health professionals is shared by most Low- and Middle-Income Countries (LMICs) and is reflected in the Treatment Gaps in this region indicating the very small proportion of people who receive adequate mental health care for their needs. While the median worldwide Treatment Gap for psychosis is 32.2% (Kohn et al., 2004), in Indonesia it is more than 90%. Experts suggested integrating mental health care into primary care, to help bridge this gap (Mendenhall et al., 2014). The systematic introduction of the World Health Organization Mental Health Gap Action Programme into primary care clinics across Indonesia and the presence of a 15-year-old co-location of Clinical Psychologists in Yogyakarta province's primary care clinics presented an opportunity to assess the clinical and cost-effectiveness of both frameworks. Methods This research ("the trial") set out to develop an approach, and then implement it, to compare the adapted WHO mhGAP framework with the existing specialist framework within primary mental health services in Yogyakarta, Indonesia, through a pragmatic, two-arm cluster randomised controlled non-inferiority trial. This design enabled an examination of patients derived from whole populations in a 'real world' setting. The trial involved two phases: a pilot study in June 2016 with the objectives to refine data collection procedures and to serve as a practice run for clinicians involved in the trial; as well as a substantive trial beginning in December 2016. The 12-item General Health Questionnaire (GHQ-12) was established as a 'fairly accurate' screening tool using a Receiver Operating Curve study. Using the GHQ scoring method of 0-0-1-1, a threshold of 1/2 was identified for use in clinical setting, i.e. the context of the trial. The primary outcome was the health and social functioning of participants as measured by the Health of the Nation Outcome Scale (HoNOS) and secondary outcomes were disability as measured by WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), quality of life as measured by European Quality of Life Scale (EQ‐5D-3L), and cost of intervention evaluated from a health services perspective, which aimed to determine the clinical effectiveness and cost-effectiveness of both frameworks at six months. Results During the recruitment period, 4944 adult primary care patients attended 27 participating primary care centres. Following screening (n=1484) and in-depth psychiatric interviews (n=394), 174 WHO mhGAP arm and 151 Specialist arm participants received a formal diagnosis and were recruited into the trial. The number of required participants per treatment arm, to provide statistical power of 0.80 and statistical bilateral significance value of 0.05 was estimated to be 96. A total of 153 participants of the WHO mhGAP arm and 141 of the Specialist arm were followed-up at six months, representing 90.8% of all participants diagnosed. At follow-up, 82% (n=126) participants of the WHO mhGAP arm indicated they had attended at least one treatment session during the trial, significantly more than in the Specialist Arm (69%; n=97), 2 = 7.364, p=0.007. The WHO mhGAP arm was proven to be statistically not inferior to the Specialist arm in reducing symptoms of social and physical impairment, reducing disability, and improving health-related quality of life at six months. Cost-effectiveness analyses show that the Specialist arm was dominant for a unit of improvement in patient outcomes at six months. While the framework is more expensive for the Health System, participants in the Specialist arm were found to have larger improvements. Conclusion Given that both frameworks yielded positive patient outcomes, there is no immediate need to increase the absolute number of specialist mental health professionals in community psychiatry (i.e. replicate the specialist framework outside Yogyakarta). As most psychologists and psychiatrists in Indonesia reside in large cities, the current systematic roll-out of the adapted WHO mhGAP framework might address the need to strengthen non-stigmatising mental health care within community contexts, reflecting the preferences of primary care patients. In districts or provinces which could afford the additional cost, however, the Specialist framework was shown to be better at improving patient outcomes than the adapted WHO mhGAP framework. Existing resources for specialist care can be arranged in a hub-and-spoke (step-up care) model where higher-level interventions are provided for those with greater needs. The proposed model would free-up resources for advanced clinical training of the specialist workforce in key areas of need while keeping specialist services accessible. Trial Registration This trial has been registered with clinicaltrials.gov since 25 February 2016, NCT02700490. Ehical Standards Full ethics approval from the University of Cambridge, UK was received on 15 December 2015 (PRE.2015.108) and from Universitas Gadjah Mada, Indonesia on 14 April 2016 (1237/SD/PL.03.07/IV/2016). A condition of ethics approval from the University of Cambridge is that the investigator is covered by indemnity insurance and that participants are insured for the period of their participation. This was provided by the University of Cambridge Trial Insurance Office (609/M/C/1510). Ethics approval from all the clusters was not required as each cluster (Puskesmas) is a local GP surgery which does not have its own ethics committee. Instead, approval to conduct research at the province of Yogyakarta including all five districts: Kota Yogyakarta, Sleman, Gunung Kidul, Kulon Progo, Bantul Districts was obtained from the Provincial Government Office (070/REG/V/625/5/2016) following ethics approvals. Written consent to participate was obtained from clinicians taking part as well as all patient-participants.
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Daures, Maguy. „Évaluation d'une stratégie de prise en charge simplifiée de la malnutrition aiguë chez des enfants de 6 à 59 mois en Afrique Sub-saharienne dans le cadre d’un programme de recherche co-construit entre humanitaires et chercheurs“. Electronic Thesis or Diss., Bordeaux, 2024. http://www.theses.fr/2024BORD0067.
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La malnutrition aiguë (MA) est un défi mondial, touchant 45 millions d'enfants de moins de 5 ans et est une cause sous-jacente de 800 000 décès annuels. Les protocoles de prise en charge, bien que efficaces, souffrent d'un financement insuffisant et d'une couverture limitée. Ces protocoles divisés en deux programmes pour les enfants malnutris aigus sévères et modérés sont complexes et utilisent des traitements différents avec des dosages non optimaux. Pour répondre à ces défis, l’organisation non gouvernementale (ONG) « The Alliance for International medical action » (ALIMA) a développé le protocole « the Optimizing treatment for acute malnutrition » (OptiMA) visant à traiter tous les enfants présentant un Périmètre Brachial (PB) < 125 mm ou des œdèmes en utilisant un unique aliment thérapeutique prêt à l’emploi (ATPE) avec un dosage dégressif en fonction du PB et du poids. En 2016, ALIMA, l’équipe de recherche GHiGS (Global Health in the Global South, Inserm/IRD/Université de Bordeaux) et le programme PAC-CI à Abidjan, ont fondé le consortium CORAL (Clinical and Operational Research Alliance) visant à co-construire une recherche entre humanitaires et chercheurs dans des pays souvent oubliés par la recherche mondiale en raison de l'instabilité politique et des conflits. Ce travail de thèse explore l'évaluation du protocole OptiMA à travers plusieurs études, dont un essai pilote au Burkina Faso et un essai clinique randomisé au Niger, conduits au sein de CORAL. Un premier essai pilote pragmatique « OptiMA Burkina Faso » mené en 2017 auprès de 4,958 enfants inclus avec PB<125mm ou œdèmes a montré une bonne compréhension de la table de dosage OptiMA à l’échelle d’un district, avec un taux de récupération de 86,3%. Néanmoins, l'absence d'un groupe de comparaison avait souligné la nécessité d'essais cliniques robustes. Le consortium CORAL a alors initié deux essais cliniques dans des contextes différents en République démocratique du Congo (RDC) puis au Niger. Ce travail se concentre sur l'essai OptiMA Niger, qui a évalué les protocoles simplifiés de prise en charge de la MA, comparant OptiMA et la stratégie ComPAS, « The Combined Protocol for Acute Malnutrition Study » (interventions) au protocole national du Niger (contrôle). ComPAS, développé par l’ONG International Rescue Committee (IRC), propose la même approche qu’OptiMA mais détermine la ration d’ATPE de façon très simplifiée sur la base seule du PB et fournit moins d’ATPE qu’OptiMA. Cet essai de non-infériorité à trois bras, randomisé individuellement et mené à Mirriah, au Niger, en 2021-22, a inclus des enfants de 6 à 59 mois souffrant de MA non compliquée définie par un PB < 125 mm ou des œdèmes. Le critère principal était l’issue favorable à 6 mois, définie comme étant en vie et sans rechute. Le critère secondaire était la récupération chez les enfants avec un PB< 115 mm ou des œdèmes défini au cours des 6 mois par : au moins 4 semaines de traitement, absence de fièvre (>37,5°), absence d'œdèmes et PB≥125 mm pendant deux semaines consécutives. Entre le 31 mars et le 23 décembre 2021, 1 732 enfants avec PB <125 mm ou œdèmes et 1 140 enfants présentant un PB <115 mm ou des œdèmes ont été randomisés (1 :1 :1). Les résultats n’ont pas démontré la non-infériorité pour les critères de jugement mais les trajectoires de gains de poids et de PB similaires 6 mois post randomisation dans les 3 bras suggèrent que la réduction progressive de la supplémentation n'a pas eu d'impact négatif sur la croissance de l’enfant, même les plus vulnérables, alors que 40 % d'enfants supplémentaires pourraient être traités sans que le coût des ATPE n'augmente. Dans cet essai mené au Niger, bien que la non-infériorité (ITT et PP) pour les critères de jugement n'ait pas été démontrée, les gains de poids et de PB similaires 6 mois post randomisation dans les bras ComPAS et contrôle suggèrent que la réduction de la ration de supplémentation (…)Acute malnutrition (AM) is a major public health concern, affecting 45 million children under 5 years of age. It is an underlying cause of 800,000 deaths each year. Existing treatment protocols, while effective, suffer from insufficient funding and limited coverage. Furthermore, these protocols, divided into two programmes for severe and moderate acute malnourished children, are complex to put in place and use different treatments with sub-optimal dosages. In response to these challenges, the non-governmental organisation (NGO) The Alliance for medical action (ALIMA) has developed the « Optimising treatment for acute malnutrition » (OptiMA) protocol. The OptiMA aims to treat any children presenting Mid-Upper Arm Circumference (MUAC)<125 mm or oedema with a single ready-to-use therapeutic food (RUTF) with degressive dosage according to MUAC and weight In 2016, ALIMA, the GHiGS research team (Global Health in the Global South, Inserm/IRD/University of Bordeaux) in Bordeaux and the PAC-CI programme in Abidjan, founded the CORAL (Clinical and Operational Research Alliance) consortium in order to co-construct research activities between humanitarians and researchers in countries often forgotten by global research due to political instability and conflict. This thesis explores the evaluation of the OptiMA protocol through several studies, including a pilot trial in Burkina Faso and a randomized clinical trial in Niger, conducted within CORAL. A first pragmatic pilot trial "OptiMA Burkina Faso" was conducted in 2017 including 4,958 children with MUAC<125mm or oedema. The study has shown a good understanding of the OptiMA dosing table at district level, which led to a recovery rate of 86.3%. However, the lack of a comparison group was an issue, highlighting the need for more robust clinical trials. The CORAL consortium therefore initiated two clinical trials in different settings in the Democratic Republic of Congo (DRC) and Niger. This thesis work focuses on the OptiMA Niger trial, which evaluated two simplified AM management protocols, namely the OptiMA and the ComPAS "The Combined Protocol for Acute Malnutrition Study" strategies (interventions), which were compared with the Niger's national protocol (control). The ComPAS, developed by the NGO International Rescue Committee (IRC) with the same approach as OptiMA, determines the RUTF in a very simplified way, based solely on MUAC, and provides fewer RUTF than OptiMA. This three-arm, individually randomized, non-inferiority controlled trial, conducted in Mirriah, Niger, in 2021-22, included children aged 6-59 months with uncomplicated AM defined by MUAC<125 mm or oedema. The primary endpoint was the « favorable » outcome at 6 months, defined as being alive and without relapse. The secondary endpoint was nutritional recovery in children with MUAC<115 mm or oedema defined over 6 months as at least 4 weeks of treatment, absence of fever (>37.5°) and MUAC≥125 mm and no oedema for two consecutive weeks. Between 31 March and 23 December 2021, 1,732 children with MUAC <125 mm or oedema and 1,140 children with MUAC <115 mm or oedema were randomized (1:1:1). The findings did not demonstrate non-inferiority for any of the main outcomes, but the similar weight and MUAC gains trajectories 6 months post-randomization in the 3 arms suggest that the progressive reduction in supplementation did not have a negative impact on growth, even for the most vulnerable children, whereas 40% more children could be treated without increasing the cost of RUTFs. These trials have provided scientific evidence needed to scale up simplified protocols in emergency health setting. The CORAL consortium demonstrated its strength through the implementation of individually randomized clinical trials conducted rigorously in complex areas
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Deak, Stefan, und Glenn Kristoffersson. „Rädslan för det som finns och inte finns : En randomiserad kontrollerad jämförelse av utfall mellan sedvanlig ensessionsbehandling och behandling med virtuella stimuli mot spindelfobi“. Thesis, Stockholms universitet, Psykologiska institutionen, 2016. http://urn.kb.se/resolve?urn=urn:nbn:se:su:diva-130712.
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Specifik fobi är en vanlig psykiatrisk åkomma som kan leda till stora individuella begränsningar. Symtomen kan framgångsrikt behandlas med kognitiv beteendeterapi där 85–90 % blir kliniskt signifikant förbättrade. Forskning påvisar lovande behandlingsutfall för virtuell exponeringsbehandling (VRET) mot spindelfobi. Tekniken är intressant då den kringgår de problem med anskaffning och förvaring av fobiska stimuli som sedvanlig behandling medför och dessutom kan innebära ökad tillgänglighet och flexibilitet vid behandling. Syftet med föreliggande studie är att jämföra behandlingseffekten av ensessionsbehandling (OST) med en nyutvecklad spelifierad virtuell exponeringsbehandling (VIMSE), som sker under en fristående behandlingssession. Totalt randomiserades 73 deltagare mellan de två behandlingsmetoderna. Båda behandlingarna medförde statistiskt signifikanta förbättringar med stora effektstorlekar för såväl det beteendetest (BAT), som utgjorde det primära utfallsmåttet (OST d = 1,94; VIMSE d = 1,41), som för de sekundära utfallsmåtten Spider Phobia Questionnaire och Fear of Spiders Questionnaire. OST resulterade i signifikant fler kliniskt signifikant förbättrade än VIMSE.VIMSE (VIrtual reality Method for Spider phobia Exposure therapy)
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Nohlert, Eva. „Smoking Cessation : Treatment Intensity and Outcome in Randomized Clinical Trials“. Doctoral thesis, Uppsala universitet, Centrum för klinisk forskning, Västerås, 2013. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-208972.
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The primary aim was to compare the effectiveness of smoking cessation interventions of different intensities in a clinical dental and a telephone setting in Sweden. Methods: A total of 300 smokers were randomized to High or Low Intensity Treatment (HIT or LIT) at the Public Dental Service, County Council of Västmanland. Effectiveness (abstinence rate) was measured after 1yr (paper I) and 5-8yrs (paper III). A cost-effectiveness analysis was conducted, based on intervention costs, number of abstinent participants after 1yr, and a Markov modelling of future costs and health (in QALYs) consequences (paper II). In paper IV, 586 callers to the Swedish National Tobacco Quitline (SNTQ) were randomized to high-intensity proactive or low-intensity reactive service, and effectiveness was measured after 1 yr. Effectiveness measures were self-reported point prevalence, 6-month continuous abstinence, and sustained abstinence. Results: Absolute quit rates were 7% higher with HIT than with LIT on all measures and increased by 8% from 1yr to 5-8yrs. Point prevalence was 23% vs. 16% (p=.11) after 1yr and 31% vs. 24% (p=.16) after 5-8yrs. Six-month continuous abstinence was 18% vs. 9% (p =.02) after 1yr and 26% vs.19% (p=.18) after 5-8yrs. Sustained abstinence was 12% vs. 5% (p =.03) after 5-8yrs. Nicotine dependence was a strong predictor for abstinence at 1yr and achieved abstinence at 1yr was a strong predictor for abstinence at long-term follow-up. The cost-effectiveness analysis showed that both HIT and LIT were cost-effective, and LIT was even cost-saving compared with doing nothing. HIT was more costly and more effective than LIT, and the cost of each extra QALY gained by HIT was 100,000SEK, which is considered very cost-effective in Sweden. Proactice and reactive services were equally effective at the SNTQ. Point prevalence was 27% and 6-month continuous abstinence was 21% after 1yr. Being smoke-free at baseline was the strongest predictor for abstinence at 1yr. Conclusion: Support at high as well as low intensity in a clinical dental setting in Sweden and at the SNTQ was effective in achieving smoking cessation. Both high- and low-intensity interventions were very cost-effective in a clinical dental setting.
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Walid, Rania. „Impact Evaluation in Post-conflict Environments : A Critical Appraisal of Randomised Controlled Trial (RCT)“. Thesis, Linnéuniversitetet, Institutionen för samhällsstudier (SS), 2021. http://urn.kb.se/resolve?urn=urn:nbn:se:lnu:diva-104816.
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Impact evaluations in development interventions has been growing in recent years. The increasing demand for evidence-based outcomes has led to a debate of what methodology is best to evaluate the impact of development interventions. Accordingly, Randomised Controlled Trial (RCT) has been labeled as a gold standard for impact evaluations. The RCT method functions in a unique way, as it removes the selection bias and ensure high validity of a study. The aim of this research study is to critically assess the RCT as an alternative approach for impact assessment in relation to post-conflict countries; whether this claim holds in a conflict-affected environment or that the context-specific factors of post-conflict countries challenge the implementation of an RCT. This study implements mixed method approach by using simple descriptive statistics and semi-structured interview to answer the research questions. The findings of this study indicate that context-specific factors of post-conflict environments pose challenges on the implementation of an RCT. As a result, these challenges threaten the quality of the RCT method which lies in reliability, internal validity and external validity. The findings also indicate that feasibility of RCT which lies in ethics, logistics and security, cannot be addressed individually, as the feasibility has a direct impact on the quality of the RCT method.
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Spieth, Peter Markus, Anne Sophie Kubasch, Ana Isabel Penzlin, Ben Min-Woo Illigens, Kristian Barlinn und Timo Siepmann. „Randomized controlled trials - a matter of design“. Saechsische Landesbibliothek- Staats- und Universitaetsbibliothek Dresden, 2017. http://nbn-resolving.de/urn:nbn:de:bsz:14-qucosa-215848.
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Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial.
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Spieth, Peter Markus, Anne Sophie Kubasch, Ana Isabel Penzlin, Ben Min-Woo Illigens, Kristian Barlinn und Timo Siepmann. „Randomized controlled trials - a matter of design“. Dove Medical Press, 2016. https://tud.qucosa.de/id/qucosa%3A29007.
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Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial.
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Featherstone, Katie. „Patient perspectives of participation in a randomised controlled trial“. Thesis, University of Bristol, 2000. http://hdl.handle.net/1983/06229618-6e8d-4764-8c7a-1f0c0d0af307.
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Schuh, Sr Matthew Anderson. „The Epistemic Necessity and Ethical Permissibility of Randomized Clinical Trials: A Minimalist Defense“. Scholarly Repository, 2008. http://scholarlyrepository.miami.edu/oa_dissertations/167.
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I argue for two main theses that are at odds with the positions of many clinical researchers and philosophers who write on the ethics of clinical research. The first is that certain types of clinical trials, namely, randomized clinical trials with double or triple blinding and a placebo group are generally necessary to establish that a medical intervention is effective in treating a certain type of disease or disorder. The second main thesis is that such trials are generally not ethically impermissible. My minimalist defense of clinical trials differs from most defenses of clinical trials found in the literature. I feel that the ethical permissibility of clinical trials can be judged by answering yes to the following questions: 1) Is the potential experimental subject competent to exercise his autonomy and his right of self determination in order to enroll in the clinical trial? 2) Is the potential experimental subject informed about the nature of risk and benefit involved in his participation in the clinical trial? 3) Is the trial scientifically/ epistemically valid? 4) Will the trial attempt to answer a scientific question or questions of value? I argue that competent persons have the right to enroll in scientifically valid clinical trials so long as they are informed and consent to participate.
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Slater, Karen. „Improving Care of Peripheral Intravenous Needleless Connectors“. Thesis, Griffith University, 2022. http://hdl.handle.net/10072/412414.
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Background: Most hospitalised patients have a peripheral intravenous catheter (PIVC) at some point during hospitalisation. Although the rate of bloodstream infection (BSI) for PIVCs is low, the sheer number of devices inserted makes them a device of interest, since cumulatively many infections occur worldwide each year. Access to intravenous (IV) lines for the administration of medication and fluids in most of the developed world is through the needleless connector (NC) component of a PIVC. NCs were introduced several decades ago to reduce the risk of needlestick injuries amongst healthcare workers. Although they have been successful in reducing needlestick injuries, there has been an unintended consequence of NCs being associated with increased patient BSI. Patient BSI leads to prolonged length of hospital stay and higher costs, as well as significant morbidity and mortality. About half of all BSIs are attributed to the insertion process and half to on-going maintenance care. One of the most important aspects of maintenance care is NC disinfection, which should take place prior to each access of the NC. When disinfection does not occur, or is inadequate, there is a risk of microorganisms gaining access to the patient’s bloodstream. The optimal cleaning duration and disinfectant agent for NC disinfection have not been established. There have been many laboratory-based studies of NC disinfection but few in the clinical environment. Establishment of the optimal disinfectant agent and disinfection duration is vital to prevent patient BSI and improve patient outcomes. It is also important to establish current practice and identify how this compares to best practice guidelines and what factors influence clinicians’ practice behaviours, since providing evidence-based practice is vital to improve patient outcomes and decrease the risk of patient BSI.Aims and Objectives The aim of this PhD was to establish the most effective method for disinfection of PIVC NCs in the clinical environment and to examine current local infection prevention practices to improve NC care. The research findings will inform healthcare worker practice in the care of PIVC NCs to prevent BSIs. Four objectives guided the three phases of the research: 1. To determine the most effective active disinfectant agent and scrub time to disinfect NCs; 2. To establish adequate NC drying times after disinfection; 3. To evaluate current local practice of PIVC NC care; and 4. To identify nurses’ self-reported practice and attitudes regarding NC care and identify factors that influence their behaviour. Design: This PhD had a multi-method research design. It was underpinned by the Mitchell and Gardiner Infection Prevention and Control conceptual framework. This framework entails a multi-faceted approach to infection prevention. There were three phases to this research: a factorial randomised controlled trial (RCT) comparing disinfectant solutions and disinfectant times, with an associated NC drying time experimental study; an observational study to establish local PIVC care; and finally, a survey of nurses’ practice and attitudes about NC care. Phase 1, Part 1: Research questions: 1. What disinfection agent, 70% isopropyl alcohol (IPA) or 2% chlorhexidine in 70% alcohol (CHG-IPA), is more effective in eliminating microorganisms on PIVC NCs? 2. What disinfection time (5, 10, or 15 seconds) is most effective in eliminating microorganisms on PIVC NCs? Setting: Tertiary adult hospital in Brisbane, Australia. Sample: 300 NCs on PIVCs of adult in-patients located on the internal medical units. Main findings: There was no statistical difference between 70% IPA and 2% CHG in 70% IPA (p = .62) in disinfecting the external surface of NCs in the clinical environment; both were effective, but neither removed all microorganisms. There was no statistical difference in the effectiveness of 5, 10, or 15 (p = .21) second scrub times. Phase 1, Part 2 Research questions: 1. What is the effective drying time of 70% IPA, 2% CHG in 70% IPA, and 10% povidone iodine for NC disinfection? 2. Does the drying time of the three recommended disinfectants differ? Setting: Non-clinical area of tertiary adult hospital in Brisbane, Australia Sample: Three commonly available disinfectant preparation pads/wipes were compared. Main findings: The drying time of the three tested disinfectants differed substantially. After a 15-second scrub, 70% IPA was consistently dry after 5 seconds and 2% CHG in 70% IPA was consistently dry after 20 seconds. Drying time for povidone iodine 10% was not established, as it remained wet at 6 minutes, making its use clinically unfeasible. Phase 2 Research questions: 1. How often do nurses decontaminate their hands prior to accessing PIVC NCs (Moment 2 of the 5 Moments of Hand Hygiene)? 2. How often do nurses disinfect PIVC NCS prior to accessing them? 3. What is the length of time that nurses spend disinfecting PIVC NCs prior to accessing them? 4. What is the length of time that nurses let NCs dry after disinfection, prior to accessing them? Setting: Tertiary adult hospital in Brisbane, Australia Sample: 108 observations of nurses working in the emergency department, two medical wards, and two surgical wards. Main findings: Compliance with disinfection of NCs was high (99%), although disinfection time was a much shorter duration than that recommended in the hospital policy (average 6.1 seconds vs 15 seconds). Compliance with hand hygiene prior to drawing up medication (33%) and immediately prior to medication administration (43%) was suboptimal. The most common duration that nurses allowed NCs to dry was 6–10 seconds. Working in the emergency department setting and use f gloves were associated with poorer compliance with hand hygiene.Phase 3: Research questions: 1. What are nurses’ self-reported practices of NC care? 2. How do self-reported practices of NC care compare to current clinical guidelines and results from previous studies? 3. What influences nurses’ behaviour in relation to NC care and how does this compare to previous studies? Setting: Tertiary adult hospital in Brisbane, Australia Sample: Registered and Enrolled nurses working within the clinical divisions. Main findings Most nurses (89%) stated that they always disinfect NCs prior to access. Nurses’ ability to recognise and undertake the correct sequencing for clamping and line/syringe disconnection was low; 79% of nurses identified the correct clamping and disconnection for negative pressure NCs, and 34% identified the correct sequencing for positive pressure devices. Nurses’ behaviour was most influenced by other senior nurses. The risk of introducing bacteria into the patient’s bloodstream was of great concern to most nurses. Conclusion: PIVC-associated BSI, reflecting suboptimal PIVC maintenance care, remains a serious problem. The results of this PhD focusing on NC disinfection highlight that NCs in the clinical environment are frequently contaminated with microorganisms found on the skin. The RCT—the first on this topic undertaken in a clinical environment—determined that the disinfectants and timeframes tested were very effective in removing most microorganisms from NCs in the clinical environment, but there was no difference between the disinfectants or application durations trialled. The drying time study—the first to examine drying time for commonly used disinfectant preparation pads/wipes on NCs—determined that IPA had the shortest drying time. The observational study established that most nurses disinfect NCs prior to access, but for a shorter duration than is currently recommended. Hand hygiene associated with NC care was suboptimal. The survey—the first comprehensive Australian study—established significant nursing knowledge gaps in NC care and identified opportunities for improvement (particularly the sequencing of disconnecting and clamping NCs and lines), which has the potential to reduce BSIs; it also established that local senior nurses were most likely to influence behaviour. Maintenance care of PIVC NCs has previously been minimally researched and is likely the missing link in infection prevention strategies. This PhD has provided comprehensive new evidence and attention now needs to be directed toward improving the maintenance care of NCs to reduce patient BSI and improve patient safety.Thesis (PhD Doctorate)
Doctor of Philosophy (PhD)
School of Nursing & Midwifery
Griffith Health
Full Text
Bücher zum Thema "Randomised clinical trial (RCT)"
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G, Zermansky A., National Co-ordinating Centre for HTA (Great Britain) und Health Technology Assessment Programme, Hrsg. Clinical medication review by a pharmacist of patients on repeat prescriptions in general practice: A randomised controlled trial. Alton: Core Research on behalf of the NCCHTA, 2002.
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Downe, Susan Mary. Reducing the risk of adverse outcome for nulliparous women using epidural analgesia in labour: A randomised clinical trial and longitudinal follow-up survey.... [Derby: University of Derby], 1999.
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Strand, Vibeke, Jeremy Sokolove und Alvina D. Chu. Design of clinical trials in rheumatology. Oxford University Press, 2013. http://dx.doi.org/10.1093/med/9780199642489.003.0030.
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Development of new therapies for rheumatic diseases requires a series of randomized controlled trials (RCTs) progressing from phase 1, 'first-in-human' to generate initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data; to phase 2, proof of concept for efficacy with safety and PK/PD data; and phase 3, designed to demonstrate definitive efficacy and safety to support regulatory approval. Important aspects of RCT designs include sample size estimations, treatment allocation, rescue, blinding, and statistical analyses of prespecified endpoints to preserve trial integrity. Over the past 15 years, significant progress has been made in the design of RCTs in rheumatoid arthritis (RA). Similarly, development and validation of composite outcome measures in psoriatic arthritis, ankylosing spondylitis, gout, and osteoarthritis have furthered trial design and treatment approvals. RCTs in systemic lupus erythematosus and other multisystem, heterogeneous diseases pose more challenges. Trial design will continue to evolve as promising therapies are introduced into the clinic.
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Strand, Vibeke, Jeremy Sokolove und Alvina D. Chu. Design of clinical trials in rheumatology. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199642489.003.0030_update_001.
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Development of new therapies for rheumatic diseases requires a series of randomized controlled trials (RCTs) progressing from phase 1, ’first-in-human’ to generate initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data; to phase 2, proof of concept for efficacy with safety and PK/PD data; and phase 3, designed to demonstrate definitive efficacy and safety to support regulatory approval. Important aspects of RCT designs include sample size estimations, treatment allocation, rescue, blinding, and statistical analyses of prespecified endpoints to preserve trial integrity. Over the past 15 years, significant progress has been made in the design of RCTs in rheumatoid arthritis (RA). Similarly, development and validation of composite outcome measures in psoriatic arthritis, ankylosing spondylitis, gout, and osteoarthritis have furthered trial design and treatment approvals. RCTs in systemic lupus erythematosus and other multisystem, heterogeneous diseases pose more challenges. Trial design will continue to evolve as promising therapies are introduced into the clinic.
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Strand, Vibeke, Jeremy Sokolove und Alvina D. Chu. Design of clinical trials in rheumatology. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780199642489.003.0030_update_002.
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Development of new therapies for rheumatic diseases requires a series of randomized controlled trials (RCTs) progressing from phase 1, ’first-in-human’ to generate initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data; to phase 2, proof of concept for efficacy with safety and PK/PD data; and phase 3, designed to demonstrate definitive efficacy and safety to support regulatory approval. Important aspects of RCT designs include sample size estimations, treatment allocation, rescue, blinding, and statistical analyses of prespecified endpoints to preserve trial integrity. Over the past 15 years, significant progress has been made in the design of RCTs in rheumatoid arthritis (RA). Similarly, development and validation of composite outcome measures in psoriatic arthritis, ankylosing spondylitis, gout, and osteoarthritis have furthered trial design and treatment approvals. RCTs in systemic lupus erythematosus and other multisystem, heterogeneous diseases pose more challenges. Trial design will continue to evolve as promising therapies are introduced into the clinic.
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Farrar, John T. Understanding clinical trials in palliative care research. Oxford University Press, 2015. http://dx.doi.org/10.1093/med/9780199656097.003.0193.
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Advances in basic science, translational, and clinical research have led to rapid improvements in our understanding of many disease processes. The randomized clinical trial (RCT) has played an important role in validating the benefits and harms of therapies thought to be potentially useful based on scientific theory or clinical observation, and has become the ‘gold standard’ for the demonstration of efficacy. As in all clinical study designs, the RCT has strengths and weaknesses that must be understood to appropriately interpret the study results. While randomization of the intended study population is the primary strength of such trials, choice of the study population, control condition, outcome measures, analysis procedure, and procedures for blinding the study participants can all affect the results. Understanding the requirements of a valid RCT and what can potentially go wrong will improve the conduct of palliative care research and the usefulness of published information in the care of patients.
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Fishman, Daniel B., Stanley B. Messer, David J. A. Edwards und Frank M. Dattilio, Hrsg. Case Studies Within Psychotherapy Trials. Oxford University Press, 2017. http://dx.doi.org/10.1093/med:psych/9780199344635.001.0001.
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The Cases Within Trials (CWT) model combines the randomized clinical trial (RCT) research design, based on quantitative group research, with richly and qualitatively detailed systematic case studies involving contrasting outcomes drawn from the experimental condition of the RCT. Chapter 1 of the book provides the broad historical and methodological context out of which the CWT method developed, including the recent dramatic growth of mixed-methods approaches in psychotherapy research generally, with an associated increase in their credibility and rigor. Chapter 2 presents the details of the CWT method and its application to Chapters 3–6, which present four specific projects that concretely illustrate the CWT method. The four projects vary across such dimensions as theoretical orientation and type of mental disorder. To facilitate comparison across projects, each is organized in three main sections, including results gained from the RCT, results gained from the case studies, and a synthesis of the two types of knowledge. Each project concludes with a commentary by an outside expert (or expert team) in the theoretical and disorder focus of the project. Chapter 7 presents an outside perspective on the four projects from a research team highly experienced in conducting and thinking about traditional RCTs. In view of the four projects as a whole, Chapter 8 presents the editors’ summary and analysis of themes and guidelines for the future embodied in the knowledge gained from the four projects.
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Elwood, Mark. Critical appraisal of a randomized clinical trial. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780199682898.003.0012.
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This chapter presents a randomised trial carried out in primary care in the UK, assessing the use of an antibiotic, chloramphenicol, for acute eye infections (conjunctivitis) in children. This study shows the challenges of conducting a high quality randomised trial in primary care, including issues of the appropriate assessment of outcome. The critical assessment follows the scheme set out in chapter 10: describing the study, assessing the non-causal explanations of observation bias, confounding, and chance variation; assessing time relationships, strength, dose-response, consistency and specificity, and applying the results to the eligible, source, and target populations; and then comparing the results with evidence from other studies, considering consistency and specificity, biological mechanisms, and coherence with the distribution of exposures and outcomes. The chapter gives a summary and table of the critical assessment and its conclusions; and comments on the impact of the study and research carried out since.
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Levy, David. History, epidemiology, and aetiology. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780198766452.003.0001.
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Outline of the key landmarks in the history of Type 1 diabetes. Epidemiology, focusing on its rising incidence and the increasing prevalence of later-onset autoimmune diabetes. Genetics are briefly covered; the evidence for and against the impact of a variety of environmental factors thought to be important in aetiology are emphasized, especially in relation to prospective randomized clinical trials (RCT) in early Type 1 diabetes, aiming to delay the onset of autoimmunity in high-risk individuals or slow the decline in C-peptide levels shortly after clinical diagnosis. The balance-risk hypothesis, which allows for inclusion of protective and promoting factors, is introduced.
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West, Amy E., Sally M. Weinstein und Mani N. Pavuluri. RAINBOW. Oxford University Press, 2017. http://dx.doi.org/10.1093/med-psych/9780190609139.001.0001.
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RAINBOW: A Child- and Family-Focused Cognitive-Behavioral Treatment for Pediatric Bipolar Disorder is a comprehensive, evidence-based treatment manual designed specifically for children ages 7–13 with bipolar spectrum disorders and their families. Developed by experts in pediatric mood disorders and tested in a randomized clinical trial (RCT), RAINBOW integrates psychoeducation and cognitive-behavioral therapy (CBT) with complementary techniques from mindfulness-based intervention, positive psychology, and interpersonal therapy to address the range of therapeutic needs of families affected by this disorder. Guided by the evidence on the neurobiological and psychosocial difficulties accompanying pediatric bipolar disorder, this treatment targets the child and family across seven core components: Routine, Affect Regulation, I Can Do It, No Negative Thoughts and Live in the Now, Be a Good Friend/Balanced Lifestyle for Parents, Oh How Do We Solve This Problem, and Ways to Get Support. Throughout the treatment, the child and family will learn how to identify mood states and triggers of mood dysregulation, and develop cognitive and behavioral strategies for improving mood stability. Children will build social skills, and caregivers will develop greater balance and self-care in their own lives. The family will learn ways to use routines, problem-solving, and social support to improve overall family functioning. Intended for qualified child-focused mental health professionals, this manual includes the conceptual background of the treatment and user-friendly step-by-step instruction in delivering RAINBOW with families, including handy session outlines and engaging worksheets for the child and caregiver(s).
Buchteile zum Thema "Randomised clinical trial (RCT)"
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Bulpitt, Christopher J. „Different Trial Designs“. In Randomised Controlled Clinical Trials, 57–83. Boston, MA: Springer US, 1996. http://dx.doi.org/10.1007/978-1-4615-6347-1_5.
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Bulpitt, Christopher J. „Information to be Collected During a Trial“. In Randomised Controlled Clinical Trials, 183–98. Boston, MA: Springer US, 1996. http://dx.doi.org/10.1007/978-1-4615-6347-1_10.
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Bulpitt, Christopher J. „The Objectives of a Randomised Controlled Trial“. In Randomised Controlled Clinical Trials, 45–55. Boston, MA: Springer US, 1996. http://dx.doi.org/10.1007/978-1-4615-6347-1_4.
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Bulpitt, Christopher J. „The Conduct of the Trial — Good Clinical Practice“. In Randomised Controlled Clinical Trials, 199–231. Boston, MA: Springer US, 1996. http://dx.doi.org/10.1007/978-1-4615-6347-1_11.
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Bulpitt, Christopher J. „How Many Subjects are Required For a Trial?“ In Randomised Controlled Clinical Trials, 85–112. Boston, MA: Springer US, 1996. http://dx.doi.org/10.1007/978-1-4615-6347-1_6.
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Nagappa, A. N., und Shvetank Bhatt. „RCT, Systematic Reviews, and Evidence-Based Medicine: Randomized Clinical Trials (RCT)“. In Perspectives in Pharmacy Practice, 321–32. Singapore: Springer Singapore, 2022. http://dx.doi.org/10.1007/978-981-16-9213-0_20.
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Tchero, Huidi. „Management of Scars in Skin of Color“. In Textbook on Scar Management, 371–77. Cham: Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-44766-3_43.
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AbstractKeloids and hypertrophic scars are abnormal scars, produced by an odd wound-healing response to trauma with a higher incidence in pigmented skin patients. They could be painful or itchy, producing functional and/or cosmetic disability. This chapter focuses on defining scars especially in pigmented skin and the different methods for treating keloids that have been investigated in the literature. Up to the present time, the ideal treatment method has not been defined, although numerous modalities have been designated. We will represent the variances among different scar types and their management methods, concentrating on their indications, modes of action, uses, safety, and efficiency of the following therapies: intralesional steroid, injections of silicone gel/sheet, radiotherapy, photodynamic therapy, electrical stimulation, surgical excision and adjuvant therapy, and cryosurgery. Combination therapies have also shown some value. Still, there is a shortage of randomized clinical trials (RCTs) evaluating such treatment modalities. Management of scar in pigmented (colored) skin is clinically challenging. Therefore, strategic assessment and targeted therapy with focus on deterring recurrence are most needed. The quality of evidence is crucial to select efficient treatments for patients with colored skin, presenting with keloid.
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de Bie, R. A., A. P. Verhagen, T. F. Lenssen und H. C. W. de Vet. „Efficacy of Low Level Laser Therapy in Ankle Sprains; a Randomised Clinical Trial“. In Hefte zur Zeitschrift „Der Unfallchirurg“, 708. Berlin, Heidelberg: Springer Berlin Heidelberg, 1997. http://dx.doi.org/10.1007/978-3-642-60913-8_260.
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Turner, J. Harvey. „Evaluation of Real-World Efficiency of 177Lu-PSMA Radioligand Therapy of Metastatic Prostate Cancer“. In Beyond Becquerel and Biology to Precision Radiomolecular Oncology: Festschrift in Honor of Richard P. Baum, 331–36. Cham: Springer International Publishing, 2024. http://dx.doi.org/10.1007/978-3-031-33533-4_33.
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AbstractThroughout the world, hundreds of patients with advanced metastatic prostate cancer are currently being treated with 177Lu-PSMA radioligands on compassionate usage protocols in accord with published guidelines of the European Association of Nuclear Medicine (EANM). However, 7 years after the introduction of 68Ga/177Lu-PSMA theranostic management of metastatic castration-resistant prostate cancer (mCRPC), it remained unapproved by any national regulatory authority, and has yet to achieve oncologist/urologist acceptance into mainstream clinical practice. The reasons for the nonacceptance of 177Lu-PSMA-radioligand therapy (RLT) are explored in this review, which charts the evolution of this very promising treatment modality, pioneered in German, Austrian, and Australian academic hospitals, from which many retrospective reports of efficacy have been published. This efficacy has subsequently been demonstrated by completion of the Pharma randomized controlled trial, the VISION Study which led to formal regulatory approval. However, in order to promote worldwide availability, and to evaluate efficiency in respect of improved survival and quality of life, the proposed WARMTH NIGHTCAP (World Association for Radiopharmaceutical and Molecular Therapy National Investigators Global Harmonised Theranostics of Cancer of Prostate) Study was designed to prospectively audit 68Ga/177Lu-PSMA RLT in a large real-world population of mCRPC patients, in up to 50 countries, now being treated on compassionate access programs. The NIGHTCAP Study did not come to fruition due to the COVID pandemic but the design principles remain valid.
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Sammour, Tarik. „Survival after Laparoscopic Surgery versus Open Surgery for Colon Cancer: Long-Term Outcome of a Randomised Clinical Trial (COLOR Trial)“. In 50 Landmark Papers every Colorectal Surgeon Should Know, 185–88. Boca Raton: CRC Press, 2024. http://dx.doi.org/10.1201/9780429285714-42.
Der volle Inhalt der QuelleKonferenzberichte zum Thema "Randomised clinical trial (RCT)"
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Novitasari, Elisa, RB Soemanto und Hanung Prasetya. „Acupuncture Therapy in Reducing Pain in Patients with Low Back Pain: Meta Analysis“. In The 7th International Conference on Public Health 2020. Masters Program in Public Health, Universitas Sebelas Maret, 2020. http://dx.doi.org/10.26911/the7thicph.05.43.
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ABSTRACT Background: With growing evidence of high prevalence in developing countries, LBP is no longer recognized as a disorder confined to high-income nations but is a major health problem globally. The functional limitations and consequent disability create a heavy economic burden on individuals and society. This study aimed to acupuncture therapy in reducing pain in patients with low back pain. Subjects and Method: A meta-analysis and systematic review was conducted by search published articles from PubMed, Google Schoolar, Mendeley, Hindawi, and Clinical key databases. Keywords used “acupuncture low back pain” OR “acupuncture chronic pain” AND “efficacy acupuncture” AND “chronic low back pain” AND “effect acupuncture for low back pain” AND “randomized controlled trial” AND “visual analogue scale”. The inclusion criteria were full text and using randomized controlled trial (RCT) study design. The articles were selected by PRISMA flow chart and the quantitative data were analyzed by Revman 5.3. Results: 7 studies were met criteria. This study showed that acupuncture therapy reduced pain in patients with low back pain (Mean Difference= -0.40; 95% CI= -0.80 to 0.01; p= 0.05) with heterogeneity I2= 83%. Conclusion: Acupuncture therapy reduces pain in patients with low back pain. Keywords: low back pain, acupuncture chronic low back pain, randomized controlled trial. Correspondence: Elisa Novitasari. Masters Program in Public Health, Universitas Sebelas Maret. Jl. Ir. Sutami 36A, Surakarta 57126, Central Java. Email: elisanovita58@gmail.com. Mobile: 085727851938. DOI: https://doi.org/10.26911/the7thicph.05.43
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Conejero Hall, Laura, Luis Puente Maestu, Myriam Calle Rubio, Walter Girón, Carlos José Alvarez Martínez, María Jesús Buendía García, Joan Serra Batllés et al. „RCT Abstract - Randomized, double-blind, placebo-controlled, phase III clinical trial with MV130, a sublingual bacterial immunotherapy to prevent COPD exacerbations“. In ERS International Congress 2021 abstracts. European Respiratory Society, 2021. http://dx.doi.org/10.1183/13993003.congress-2021.rct207.
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Lera Dos Santos, M. E., I. M. Proença, S. E. Matuguma, S. Cheng, J. R. De Freitas Junior, I. B. Ribeiro, D. T. H. De Moura und E. Guimaraes Hourneaux De Moura. „SELF-EXPANDABLE METAL STENT (SEMS) VERSUS LUMEN-APPOSING METAL STENT (LAMS) FOR EUS-DRAINAGE OF PANCREATIC FLUID COLLECTIONS: RANDOMIZED CLINICAL TRIAL (RCT)“. In ESGE Days 2022. Georg Thieme Verlag KG, 2022. http://dx.doi.org/10.1055/s-0042-1745234.
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Fatati, Muhibbah, Setyo Sri Rahardjo und Hanung Prasetya. „Lateral Wedge Insole Uptake in Reducing Pain in Patients with Knee Osteoarthritis: A Meta-Analysis Study“. In The 7th International Conference on Public Health 2020. Masters Program in Public Health, Universitas Sebelas Maret, 2020. http://dx.doi.org/10.26911/the7thicph.05.45.
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ABSTRACT Background: The increase in rates of knee replacement for osteoarthritis has made the identification of effective nonsurgical treatments a high priority. One type of treatment for medial knee osteoarthritis involves reducing medial loading to ease the physical stress applied to that compartment of the joint. The wedge is placed under the sole of the foot and angulated so that it is thicker over the lateral than the medial edge, transferring loading during weight bearing from the medial to the lateral knee compartment. This study aimed to investigate the effect of lateral wedge insole uptake in reducing pain in patients with knee osteoarthritis. Subjects and Method: A meta-analysis and systematic review conducted by search published articles from PubMed, Science Direct, Google Scholar, Mendeley, and Clinical key databases. Keywords used “Lateral Wedge Insole” OR “Insole” AND “Foot Orthosis “AND “osteoarthritis” AND “patellofemoral osteoarthritis” AND “knee pain” AND “medial knee osteoarthritis “AND” effect lateral wedge insole for osteoarthritis” AND “randomized controlled trial”. The inclusion criteria were full text, using randomized controlled trial (RCT) study design, and reporting effect size (mean and standard deviation). The intervention was lateral wedge insole with comparison non lateral wedge insole. The study outcome was pain. The data were analyzed by Revman 5.3. Results: 6 studies were met the inclusion criteria. This study showed that the use of lateral wedge insole reduced pain in patients with knee osteoarthritis (Mean Difference= -0.17; 95% CI= -0.51 to 0.18; p= 0.340) with heterogeneity I2= 77%. Conclusion: Lateral wedge insole use reduced pain in patients with knee osteoarthritis. Keywords: knee osteoarthritis, lateral wedge insole, randomized control trial Correspondence: Muhibbah Fatati, Masters Program in Public Health, Universitas Sebelas Maret. Jl. Ir. Sutami 36A, Surakarta 57126, Central Java. Email: muhibbahfatati@gmail.com. Mobile: 089633466598. DOI: https://doi.org/10.26911/the7thicph.05.45
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Aggarwal, N. R., J. Nordwall, T. Der, N. Eriobu, A. A. Ginde, J. W. Hayanga, H. C. Highbarger et al. „Association and Additive Risk of Respiratory and Viral Response Baseline Variables With Mortality in Therapeutics for Inpatients With COVID-19 (TICO) Platform Randomized Clinical Trial (RCT) Participants“. In American Thoracic Society 2023 International Conference, May 19-24, 2023 - Washington, DC. American Thoracic Society, 2023. http://dx.doi.org/10.1164/ajrccm-conference.2023.207.1_meetingabstracts.a6556.
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Saputri, Nurul Aini Suria, Tri Nugraha Susilawati und Vitri Widyaningsih. „Relative Efficacy of Probiotics Compared with Standard Therapy for Diarrhea Treatment in Children Under Five Years of Age: A Meta-Analysis Evidence from Developing Countries“. In The 7th International Conference on Public Health 2020. Masters Program in Public Health, Universitas Sebelas Maret, 2020. http://dx.doi.org/10.26911/the7thicph.03.95.
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ABSTRACT Background: Probiotics have been widely studied in a variety of gastrointestinal diseases. There is high-quality evidence that probiotics are effective for acute infectious diarrhea. This study aimed to examine the relative efficacy of probiotics compared with standard therapy for diarrhea treatment in children under five using meta-analysis. Subjects and Method: A meta-analysis was carried out using systematic PRISMA guidelines. The review process begins with searching for articles published between 2009 and 2019 from PubMed, Clinical Key, ScienceDirect, and Scopus databases. This study obtained four articles that meet the criteria of the randomized controlled trial (RCT), the study subjects were toddlers and conducted in developing countries. A sample of 995 children was divided into two groups, 518 children received probiotics (intervention) and 477 children received standard therapy (control). The data were analyzed by Review Manager (RevMan) software 5.3 to assess Standardized Mean Difference (SMD). Results: Probiotics administration reduced duration of acute diarrhea in children under five than standard therapy, with pooled estimate= 0.30 (SMD= -0.30; 95% CI= – 0.56 to -0.03). Conclusion: Probiotics administration combined with standard therapy is effective to reduce the duration of acute diarrhea in children under five in developing countries. Keywords: acute diarrhea, probiotic, children under five Correspondence:Nurul Aini Suria Saputri. Midwifery Department, School of Health Polytechnics, Tanjungpinang/ Masters Program in Public Health, Universitas Sebelas Maret. Jl. Arief Rahman Hakim No.1, Tanjungpinang, Riau Islands. Email: ainisuriasaputri@gmail.com. Mobile: +6285743401971. DOI: https://doi.org/10.26911/the7thicph.03.95
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Goodwin, PJ, M. Ennis, DW Cescon, C. Elser, R. Haq, CM Hamm, AE Lohmann et al. „Abstract P1-16-03: Phase II randomized clinical trial (RCT) of metformin (MET) vs placebo (PLAC) in combination with chemotherapy (CXT) in refractory locally advanced (LABC) or metastatic breast cancer (MBC)“. In Abstracts: 2018 San Antonio Breast Cancer Symposium; December 4-8, 2018; San Antonio, Texas. American Association for Cancer Research, 2019. http://dx.doi.org/10.1158/1538-7445.sabcs18-p1-16-03.
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El Hajj, Maguy, Ahmed Awaisu, Nadir Kheir, Mohamad Haniki, Rula Shami, Rana Saleh, Noora AlHamad, Ahmed Almulla und Ziyad Mahfoud. „Assessment of an Intensive Education Program on the Treatment of Tobacco-Use Disorder for Pharmacists using OSCE (Objective Structured Clinical Examination)“. In Qatar University Annual Research Forum & Exhibition. Qatar University Press, 2020. http://dx.doi.org/10.29117/quarfe.2020.0113.
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Tobacco use is one of the main causes of morbidity and mortality in Qatar. The aim of this randomized controlled trial (RCT) is to design, implement, and evaluate an intensive education program on tobacco-use treatment for pharmacists in Qatar. The study objectives are to assess the effectiveness of the program on pharmacists’ skills toward tobacco cessation. Methods: A random sample of community pharmacists in Qatar was selected for participation. Consenting participants were randomly allocated to intervention or control groups. Participants in the intervention group received an intensive education program on treatment of tobacco-use disorder. A short didactic session on a non-tobacco-related topic was delivered to pharmacists in the control group. The pharmacists’ tobacco cessation skills were assessed using an Objective Structured Clinical Examination (OSCE). Six-station OSCE targeting core smoking cessation competencies and skills was completed by participants in both groups. Performance of participants was assessed using validated assessment checklists that comprised analytical and global assessment sections. Results: A total of 54 and 32 participants in the intervention and the control group respectively completed the OSCE. Overall, pharmacists in the intervention group performed better in the analytical and global assessment sections than those in the control group. For example, for case 1, mean scores for developing rapport, data gathering and management were 2.76 vs 0.97 (p-<0.001), 5 vs 2.81 (p <0.001), and 3.5 vs 2.25 (p=0.001) respectively for the intervention group compared to the control group. Mean total analytical scores were 12.06 vs 6.4 (p-<0.001) for intervention compared to the control group for case 1. Furthermore, mean global assessment scores for case 1 were 3.19 vs 2.41 (p=0.009) for the intervention compared to the control group. Conclusion: The study results suggest that provision of an intensive educational program on the treatment of tobacco use results in improved skills toward tobacco cessation.
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Mcdonald, Vanessa, Vanessa Clark, Peter Wark, Katherine Baines und Peter Gibson. „Multidimensional assessment and targeted therapy of severe asthma: a randomised controlled trial (RCT)“. In ERS International Congress 2017 abstracts. European Respiratory Society, 2017. http://dx.doi.org/10.1183/1393003.congress-2017.oa1482.
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Dhooria, Sahajal, Inderpaul Singh Sehgal, Ritesh Agarwal, Kuruswamy Thurai Prasad und Ashutosh Nath Aggarwal. „RCT Abstract - High-dose (40 mg) versus low-dose (20 mg) prednisolone for treating sarcoidosis: a randomised trial (SARCORT trial)“. In ERS International Congress 2023 abstracts. European Respiratory Society, 2023. http://dx.doi.org/10.1183/13993003.congress-2023.rct797.
Der volle Inhalt der QuelleBerichte der Organisationen zum Thema "Randomised clinical trial (RCT)"
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Villa, Michele, Massimo Le Pera und Michela Bottega. Quality of Abstracts in Randomized Controlled Trials Published in Leading Critical Care Nursing Journals. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, Juni 2022. http://dx.doi.org/10.37766/inplasy2022.6.0039.
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Review question / Objective: This review aims to evaluate the methodological quality of RCT-abstracts in leading critical care nursing journals. A methodological quality review with the Consolidated Standards of Reporting Trials (CONSORT) criteria will be performed in RCT-abstracts published between 2011-2021 in the first Scopus-ranking (2021) nursing journals. Eligibility criteria: Abstracts of scientific articles will be included if they fulfil the following inclusion criteria: 1) they report the results of parallel and/or cross-over group RCTs, 2) they are written in English, 3) they refer to the care of adult patients with acute/critical illness or conducted in adult ICUs.Manuscripts reporting results of pilot or feasibility studies, cluster trials, observational or cohort studies, interim analyses, economic analyses of RCTs, post-trial follow-up studies, subgroup and secondary analyses of previously published RCTs, editorials and RCTs without an abstract such as RCTs published as letters to the editor, single-subject clinical trials will be excluded.
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Moxham-Hall, Vivienne, Anton du Toit, Sallie Newell, Stuart Brentnall, Deshanie Rawlings und Eileen Goldberg. Proton beam therapy: a rapid review of the evidence since 2020. The Sax Institute, April 2023. http://dx.doi.org/10.57022/nbys4168.
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This report for Cancer Australia is a rapid review of the evidence since 2020 on proton beam therapy (PBT) for paediatric cancers, central nervous system (CNS) tumours, head and neck cancer and prostate cancer. The report aims to provide a rapid summary of the current knowledge about PBT’s effectiveness, safety, and potential advantages over conventional radiation therapy. We identified the following papers for full review: 24 peer reviewed papers, including 4 meta-analyses, 16 systematic reviews, 3 narrative reviews, and 1 randomised controlled trial (RCT); and 2 publicly available health technology assessments (HTAs) in the grey literature. The overall quality of evidence in these reviews was limited due to factors such as small sample sizes, non-randomised study designs, heterogeneity in study designs, and short follow-up periods. Many reviews noted that there is a need for well-designed randomised and model-based clinical trials to provide a stronger evidence base for PBT for particular cancer types. Note that this rapid review was completed within a three-week timeframe so while searches were performed systematically, it is possible that some literature may have been missed. Overall, there is a need for more high-quality evidence to better understand the effectiveness, safety, and cost-effectiveness of PBT in various cancer types and populations.
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Shi, Min, Yao Yao, Haifeng Ding, Jian Yang, Zhen Feng, Yingying Jiang und Tao Guo. The Pharyngeal Packs for Dental and Otolaryngological Surgery: A Meta-analysis of High-quality RCTs. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, Februar 2023. http://dx.doi.org/10.37766/inplasy2023.2.0002.
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Review question / Objective: To quantitatively evaluate the role of pharyngeal packing in dental and otolaryngological surgeries by meta-analysis Eligibility criteria: Trials were included if they met the following criteria: (1) high-quality randomized controlled trial; (2) application of pharyngeal pack was the only intervention; (3) investigations of dental and otolaryngological surgeries; (4) full English text could be identified; and (5) at least one available parametric indicator was addressed.The exclusion criteria were as follows: (1) low-quality RCT or non-RCT; (2) pharyngeal pack was not the only intervention or the comparison of different pack types; (3) full English text could not be traced; (4) absence of information on selected raw data; and (5) irrelevant studies, reviews, comments or clinical case reports.
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Li, Yaodong, Zuoqiong Zhou, Yiping WANG, Gang MAI, Yangyun HANG, Lingling ZHU, Ming ZHAO et al. Comparison of oral sodium phosphate tablets and polyethylene glycol lavage solution for colonoscopy preparation: A systematic review and meta-analysis of randomized clinical trials. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, Mai 2023. http://dx.doi.org/10.37766/inplasy2023.5.0013.
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Review question / Objective: To systematically compare the bowel cleaning ability, patient tolerance and safety of oral sodium phosphate tablets (NaPTab) and oral polyethylene glycol electrolyte lavage solution (PEGL) to inform clinical decision making. Review question include: 1) patient populations with an indication for colonoscopy, including outpatients or inpatients requiring diagnosis or treatment, 2) randomized controlled trial (RCT) study designs, 3) a sodium phosphate tablet intervention group, 4) a control group receiving PEGL administered orally or by nasogastric tube, and 5) outcome measures including cleansing quality, adverse effects, patient acceptance, and changes in serum electrolytes after preparation.
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Xing, Lei, Hongmin Guo und Zhiqian Wang. Efficacy and safety of Suzi Jiangqi Decoction in patients with acute exacerbation of chronic obstructive pulmonary disease A protocol for systematic review and meta analysis. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, August 2021. http://dx.doi.org/10.37766/inplasy2021.8.0035.
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Background: Chronic obstructive pulmonary disease (COPD) is characterized by chronic respiratory symptoms. The respiratory symptoms of patients with acute exacerbation of COPD (AECOPD) worsen rapidly. At present, traditional western medicine treatment can not effectively alleviate the symptoms and attack frequency of patients. Suzi Jiangqi decoction(SZJQ) has a good clinical effect in the treatment of AECOPD. Due to the lack of evidence-based medicine, it can not provide an effective systematic evaluation for the treatment of AECOPD with Suzi Jiangqi decoction. Therefore, it is necessary to provide high-quality evidence evaluation for the clinical efficacy and safety of Suzi Jiangqi Decoction in the treatment of AECOPD. Methods: Two researchers independently retrieved randomized controlled trial (RCT) and quasi-RCTs of SZJQ in the treatment of AECOPD from databases including PubMed, Web of science, the Cochrane Library, CBM, CNKI, Sinomed, VIP and WanFang.The included studies were evaluated for quality according to the RCT quality assessment method provided by Cochrane Reviewer's Handbook 5.3.Review Manager 5.3 software provided by the Cochrane collaboration was used for meta-analysis. Results: This study will provide systematic review on the efficacy and safety of SZJQ as adjuvant therapy in patients with AECOPD by rigorous quality assessment and reasonable data synthesis. Conclusions: This systematic review will provide the good evidence currently on SZJQ as adjuvant therapy in patients with AECOPD.
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Han, Nana, Yang Fang, Guozhen Zhao und Bo Ji. The comparative efficacy and safety of acupuncture for mild and moderate Alzheimer's disease: A systematic review and network meta-analysis. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, November 2021. http://dx.doi.org/10.37766/inplasy2021.11.0014.
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Review question / Objective: According to the current randomized clinical trials (RCT) of acupuncture therapy for Alzheimer's disease (AD), to evaluate their methodology, the quality of evidence and the report are evaluated and summarize evidence of important outcomes of randomized clinical trials. We aim to provide accurate clinical decision-making for acupuncture treatment of Alzheimer's disease. Condition being studied: According to the current randomized clinical trials (RCT) of acupuncture therapy for Alzheimer's disease (AD), to evaluate their methodology, the quality of evidence and the report are evaluated and summarize evidence of important outcomes of randomized clinical trials. We aim to provide accurate clinical decision-making for acupuncture treatment of Alzheimer's disease.
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Tang, Li-li, Yue-dong Liu, Hong-wu Tao, Wen-zhe Feng, Yu-ping Shu und Fan-yan Meng. The efficacy and safety of ulcerative colitis treatment based on the theory of the " lung–gut axis ": a meta-analysis. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, März 2023. http://dx.doi.org/10.37766/inplasy2023.3.0014.
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Review question / Objective: The purpose of this study was to investigate the difference between the curative effect of traditional Chinese medicine or integrated traditional Chinese and Western medicine on ulcerative colitis under the guidance of lung-intestine axis theory and that of Western medicine alone. The selected research method was to search relevant randomized controlled trial in Chinese and English medical databases. The Cochrane bias risk assessment tool was used to analyze the quality of RCT studies, and RevMan 5.3 was used for efficacy evaluation and meta-analysis. Condition being studied: Ulcerative colitis (UC) is a nonspecific intestinal inflammatory disease that often involves the rectum and colon submucosa. It is characterized by abdominal pain, diarrhea and purulent bloody stool. There is no specific therapy for ulcerative colitis at present. This study investigates the curative effect of traditional Chinese medicine or integrated traditional Chinese and Western medicine therapy on UC under the guidance of lung-intestine axis theory and provides a theoretical basis for the clinical treatment of UC.
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Yan, Miao, Shuang Xia und Yichang Zhao. Risk of sepsis in cancer patients treated with immune checkpoint inhibitors: a safety meta-analysis of randomized controlled trials. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, April 2022. http://dx.doi.org/10.37766/inplasy2022.4.0174.
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Review question / Objective: The aim of this meta-analysis is to estimate the risk of sepsis in cancer patients treated with immune checkpoint inhibitors in randomized controlled trials (RCTs). Condition being studied: Sepsis-related toxicities in cancer patients received immune checkpoint inhibitors. Information sources: Electronic databases:Medline; Embase; Central; Trial registers: ClinicalTrails.gov. EU Clinical Trials Register. International Clinical Trials Registry Platform. Regarding RCTs for which we had neither available adverse events on ClinicalTrials.gov nor available adverse events in publications, corresponding authors or sponsors of the study were contacted by e-mail to provide the required information.
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Wang, Jiajie, Wei Huang, Yanji Zhang, Zhengrong Zhao und Zhongyu Zhou. Acupuncture and related interventions for the treatment of obesity: protocol for a scoping review of randomized controlled trials. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, März 2022. http://dx.doi.org/10.37766/inplasy2022.3.0099.
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Review question / Objective: The purpose of this study is to summarize the characteristics of RCT in the treatment of obesity by acupuncture and other related intervention measures, so as to enhance evidence-based clinical practice about acupuncture for obesity. Condition being studied: Obesity is a chronic metabolic disease that is defined as a body's excessive accumulation or abnormal distribution of total or local fat content. Their complications such as Type II diabetes mellitus, hyperlipidemia, and cardiovascular diseases are strongly related to higher risks of mortality. In recent years, with the changes in diet structure and living habits, 1.9 billion adults were overweight and over 650 million were obese according to the report by the WHO in 2016. Acupuncture is a characteristic therapy of traditional Chinese medicine, which is effective and safe for the treatment of simple obesity. In recent years, many RCTs using acupuncture in simple obesity were carried out within and outside of China. But currently, acupuncture treatment has no uniform standard, and there are a number of problems with this current clinical application of modern Chinese Medicine. Unfortunately, there is an absence of high-quality data supporting their use. This scoping review aims to summarize the characteristics of RCT in the treatment of obesity by acupuncture and other related intervention measures, so as to enhance evidence-based clinical practice about acupuncture and moxibustion for obesity.
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Luo, Minjing, Yilin Li, Yingqiao Wang, Jinghan Huang, Zhihan Liu, Yicheng Gao, Qianyun Chai, Yuting Feng, Jianping Liu und Yutong Fei. The Fragility of Statistically Significant Findings from Depression Randomized Controlled Trials. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, April 2023. http://dx.doi.org/10.37766/inplasy2023.4.0086.
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Review question / Objective: The Fragility of Statistically Significant Findings from Depression Randomized Controlled Trials. Condition being studied: Depression is a mental disorder characterized by a range of symptoms, including loss of memory and sleep, decreased energy, feelings of guilt or low mood, disturbed appetite, poor concentration, and an increased risk of suicide. According to a systematic analysis of the Global Burden of Disease Study 2019, depression is recognized as the leading cause of disease burden for mental disorders, accounting for the largest proportion of disability-adjusted life years (DALYs) at 37.3%. The fragility index (FI), which is the minimum number of changes from events to non-events resulting in loss of statistical significance, has been suggested as a means to aid the interpretation of trial results, as the potential inadequacy about robustness of threshold P-value as a tool for reporting binary outcomes in clinical trials. In this systematic review, we want to calculate the FI of randomized controlled trials (RCTs) in depression.