Displaying publications 1 - 20 of 311 in total

  1. Pratoomsoot C, Sruamsiri R, Dilokthornsakul P, Chaiyakunapruk N
    PLoS One, 2015;10(1):e108681.
    PMID: 25633206 DOI: 10.1371/journal.pone.0108681
    Many randomised controlled trials (RCTs) of herbal interventions have been conducted in the ASEAN Communities. Good quality reporting of RCTs is essential for assessing clinical significance. Given the importance ASEAN placed on herbal medicines, the reporting quality of RCTs of herbal interventions among the ASEAN Communities deserved a special attention.
    Matched MeSH terms: Randomized Controlled Trials as Topic*
  2. Nagendrababu V, Duncan HF, Bjørndal L, Kvist T, Priya E, Jayaraman J, et al.
    Int Endod J, 2020 Jun;53(6):774-803.
    PMID: 32266988 DOI: 10.1111/iej.13304
    Well-designed and properly conducted randomized clinical trials provide a true estimate of the effects of interventions and are acknowledged as the gold standard in terms of clinical study design. However, the quality of randomized clinical trials published in the field of Endodontics is suboptimal. The Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) 2020 guidelines were developed exclusively for Endodontics by integrating and adapting the CONsolidated Standards of Reporting Trials (CONSORT) statement and Clinical and Laboratory Images in Publications (CLIP) principles, through an accepted and well-documented consensus process. Full implementation of the PRIRATE 2020 guidelines will minimize potential sources of bias and thus enhance the standard of manuscripts submitted for publication, which will ultimately improve the reporting of randomized clinical trials in Endodontics. The aim of this document is to provide an explanation for each item in the PRIRATE 2020 checklist and flowchart with examples from the literature in order to help authors understand their rationale and significance. A link to this PRIRATE 2020 explanation and elaboration document is available on the Preferred Reporting Items for study Designs in Endodontology (PRIDE) website at http://www.pride-endodonticguidelines.org/prirate/.
    Matched MeSH terms: Randomized Controlled Trials as Topic*
  3. Western JS, Dicksit DD
    J Conserv Dent, 2016 Jul-Aug;19(4):343-6.
    PMID: 27563183 DOI: 10.4103/0972-0707.186457
    AIM OF THIS STUDY: The aim was to evaluate the efficiency of different sterilization methods on extracted human teeth (EHT) by a systematic review of in vitro randomized controlled trials.
    METHODOLOGY: An extensive electronic database literature search concerning the sterilization of EHT was conducted. The search terms used were "human teeth, sterilization, disinfection, randomized controlled trials, and infection control." Randomized controlled trials which aim at comparing the efficiency of different methods of sterilization of EHT were all included in this systematic review.
    RESULTS: Out of 1618 articles obtained, eight articles were selected for this systematic review. The sterilization methods reviewed were autoclaving, 10% formalin, 5.25% sodium hypochlorite, 3% hydrogen peroxide, 2% glutaraldehyde, 0.1% thymol, and boiling to 100°C. Data were extracted from the selected individual studies and their findings were summarized.
    CONCLUSION: Autoclaving and 10% formalin can be considered as 100% efficient and reliable methods. While the use of 5.25% sodium hypochlorite, 3% hydrogen peroxide, 2% glutaraldehyde, 0.1% thymol, and boiling to 100°C was inefficient and unreliable methods of sterilization of EHT.
    KEYWORDS: Autoclaving; extracted human teeth; formalin; sterilization methods; systematic review
    Matched MeSH terms: Randomized Controlled Trials as Topic
  4. Duncan HF, Nagendrababu V, Bjørndal L, Kvist T, Dummer PMH
    Int Endod J, 2020 Jun;53(6):731-732.
    PMID: 32396666 DOI: 10.1111/iej.13297
    Matched MeSH terms: Randomized Controlled Trials as Topic
  5. Nagendrababu V, Dummer PMH
    Int Endod J, 2020 Jul;53(7):885-886.
    PMID: 32533798 DOI: 10.1111/iej.13309
    Matched MeSH terms: Randomized Controlled Trials as Topic
  6. Nagendrababu V, Duncan HF, Pulikkotil SJ, Dummer PMH
    Int Endod J, 2021 Mar;54(3):354-365.
    PMID: 33089501 DOI: 10.1111/iej.13434
    Randomized clinical trials are positioned at the highest level of primary clinical evidence, as they are designed to be unbiased with a reduced risk of systematic error. The Consolidated Standards of Reporting Trials (CONSORT) statement was first developed in 1996 to improve the reporting quality of randomized clinical trials with updates being published subsequently. Recently, the Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) 2020 guidelines were developed exclusively for the field of Endodontics to address the suboptimal quality of randomized clinical trials submitted to Endodontic journals, which result in many being rejected. A principal flaw in submissions is the fact that many authors are unclear on the keys terms that should be used when developing manuscripts for publication. Clearly, authors should be aware of the most common terms used when conducting and reporting randomized clinical trials. Hence, the aim of the current paper is to present a comprehensive glossary of the terminology used in randomized clinical trials in order to assist authors when designing, executing and writing-up randomized clinical trials.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  7. Shamsudin N, Fleischer AB
    J Drugs Dermatol, 2010 Oct;9(10):1221-6.
    PMID: 20941946
    BACKGROUND: A topical comparison in a randomized controlled trial (RCT) should correctly be termed a vehicle rather than a placebo as the vehicle in a dermatologic drug product enhances delivery and efficacy of the active compound.
    OBJECTIVES: To conduct a systematic review of RCTs involving topical drugs published in the Archives of Dermatology, Journal of the American Academy of Dermatology and British Journal of Dermatology for correct classification of studies as vehicle versus placebo-controlled.
    METHODS: RCTs involving topical drugs published in the Archives of Dermatology, Journal of the American Academy of Dermatology and British Journal of Dermatology from January 1999 to November 2008 were identified through PubMed, supplemented by citation lists from the individual journals' web pages. Only original studies that involved using a topical control or used the term topical "vehicle" or "placebo" were selected. The studies were examined for correct classification as vehicle-controlled, the year of publication, country of origin, sample size, funding source and nature of study center.
    RESULTS: Out of 132, 64 (49%) correctly classified their studies as vehicle-controlled. Pharmaceutical-funded studies (55%, P=0.01) were significantly associated with the use of correct classification.
    LIMITATIONS: As only three peer-reviewed dermatology journals were studied, findings may not be generalized to other dermatology journals and other types of publications.
    CONCLUSION: This systematic review highlights a common pitfall in the reporting of studies of topical dermatology drugs.
    Matched MeSH terms: Randomized Controlled Trials as Topic*
  8. Lai NM, Ong JMJ, Chen KH, Chaiyakunapruk N, Ovelman C, Soll R
    Neonatology, 2019;116(2):123-131.
    PMID: 31108494 DOI: 10.1159/000497423
    BACKGROUND: The introduction of Neonatology as a subspecialty in 1960 has stimulated an enormous amount of neonatal research. A large proportion of neonatal randomized-controlled trials (RCTs) have been included in the Cochrane reviews, within which methodological quality or risk-of-bias (ROB) assessment is an integral feature.

    OBJECTIVES: We described the ROB profile of neonatal RCTs published since the 1950s.

    METHODS: We analyzed individual studies within the Cochrane Neonatal reviews published up to December 2016. We extracted the reviewers' judgments on the ROB domains including random sequence generation, allocation concealment, blinding, incomplete outcome data, and selective reporting. We evaluated blinding of personnel in trials in which blinding was considered feasible.

    RESULTS: We assessed 1980 RCTs published between 1952 and 2016 from 294 Cochrane Neonatal systematic reviews, with full ROB assessments performed in 848 trials (42.8%). Among the ROB domains, the highest proportion of trials (73%) were judged as satisfactory ("low risk") in handling incomplete outcome data, while fewest trials achieved blinding of outcome assessor (38.4%). In the last 6 decades, a progressive increase has been observed in the proportion of trials that were rated as low risk in random sequence generation, allocation concealment, and selective reporting. However, blinding was achieved in less than half of the trials with no clear improvement across decades (23-44% since the 1980s).

    CONCLUSIONS: Despite steady improvement in the overall quality of neonatal RCTs over the last 6 decades, blinding remained unsatisfactory in the majority of the trials.

    Matched MeSH terms: Randomized Controlled Trials as Topic*
  9. Nagendrababu V, Duncan HF, Bjørndal L, Kvist T, Priya E, Jayaraman J, et al.
    Int Endod J, 2020 Jun;53(6):764-773.
    PMID: 32196696 DOI: 10.1111/iej.13294
    In evidence-based health care, randomized clinical trials provide the most accurate and reliable information on the effectiveness of an intervention. This project aimed to develop reporting guidelines, exclusively for randomized clinical trials in the dental specialty of Endodontology, using a well-documented, validated consensus-based methodology. The guidelines have been named Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) 2020. A total of eight individuals (PD, VN, HD, LB, TK, JJ, EP and SP), including the project leaders (PD and VN) formed a steering committee. The committee developed a checklist based on the items in the Consolidated Standards of Reporting Trials (CONSORT) guidelines and Clinical and Laboratory Images in Publications (CLIP) principles. A PRIRATE Delphi Group (PDG) and PRIRATE Face-to-Face Meeting group (PFMG) were also formed. Thirty PDG members participated in the online Delphi process and achieved consensus on the checklist items and flowchart that make up the PRIRATE guidelines. The guidelines were discussed at a meeting of the PFMG at the 19th European Society of Endodontology (ESE) Biennial congress, held on 13 September 2019 in Vienna, Austria. A total of 21 individuals from across the globe and four steering committee members (PD, VN, HD and LB) attended the meeting. As a consequence of the discussions, the guidelines were modified and then piloted by several authors whilst writing a manuscript. The PRIRATE 2020 guidelines contain a checklist consisting of 11 sections and 58 individual items as well as a flowchart, considered essential for authors to include when writing manuscripts for randomized clinical trials in Endodontics.
    Matched MeSH terms: Randomized Controlled Trials as Topic*
  10. Ng CA, Ho JJ, Lee ZH
    PLoS One, 2019;14(4):e0215869.
    PMID: 31022227 DOI: 10.1371/journal.pone.0215869
    BACKGROUND: The benefits of six months exclusive breastfeeding are well established for both mother and infant. One of the 10 steps of the Baby Friendly Hospital Initiative is rooming-in (mother and baby together in the same room throughout hospitalisation). A Cochrane review found only one randomised controlled trial (RCT) examining the effects of continuous rooming-in versus nursery care on breastfeeding duration, and concluded there was insufficient evidence to support or refute either practice. We aimed to examine the effect of continuous or intermittent rooming-in on breastfeeding duration.

    METHODS AND FINDINGS: We included all prospective controlled studies (randomised and non-randomised) comparing rooming-in to nursery care that reported full or partial breastfeeding up to six months. We used the 2016 search results of the Cochrane review and updated the search to August 2018 using OVID MEDLINE. Duplicate data extraction and assessment of risk of bias were performed. Meta-analyses were performed using REVMAN 5. The GRADE approach was used to assess quality of evidence. Seven studies were included, five had 24-hour-per-day, one daytime only and one 8-hours-per-day rooming-in. Four studies had at least one additional co-intervention: Differences in delivery room management, and educational packages. All studies contributing to meta-analyses had 24-hour rooming-in. There was no difference in the proportion of infants on full breastfeeding at 3 months (RR 1.14; 95% CI 0.84 to 1.54; very-low-quality evidence), 4 months (RR 0.99; 95% CI 0.73 to 1.33; very-low-quality evidence) and 6 months (RR 0.95; 95% CI 0.57 to 1.58; low-quality evidence). The proportion of infants on partial breastfeeding at 3-4 months was higher with rooming-in (RR 1.31; 95% CI 1.06 to 1.61; very-low-quality evidence).

    CONCLUSION: The addition of non-randomised prospective controlled studies to existing evidence did not add further information on the effects of rooming-in on breastfeeding duration but resulted in lower quality of evidence. Uncertainty about the effects of rooming-in on breastfeeding duration remains.

    Matched MeSH terms: Randomized Controlled Trials as Topic*
  11. Mazhar F, Hadi MA, Kow CS, Marran AMN, Merchant HA, Hasan SS
    Int J Infect Dis, 2020 Dec;101:107-120.
    PMID: 33007453 DOI: 10.1016/j.ijid.2020.09.1470
    OBJECTIVES: We critically evaluated the quality of evidence and quality of harm reporting in clinical trials that evaluated the effectiveness of hydroxychloroquine (HCQ) or chloroquine (CQ) for the treatment of coronavirus disease 2019 (COVID-19).

    STUDY DESIGN AND SETTING: Scientific databases were systematically searched to identify relevant trials of HCQ/CQ for the treatment of COVID-19 published up to 10 September 2020. The Cochrane risk-of-bias tools for randomized trials and non-randomized trials of interventions were used to assess risk of bias in the included studies. A 10-item Consolidated Standards of Reporting Trials (CONSORT) harm extension was used to assess quality of harm reporting in the included trials.

    RESULTS: Sixteen trials, including fourteen randomized trials and two non-randomized trials, met the inclusion criteria. The results from the included trials were conflicting and lacked effect estimates adjusted for baseline disease severity or comorbidities in many cases, and most of the trials recruited a fairly small cohort of patients. None of the clinical trials met the CONSORT criteria in full for reporting harm data in clinical trials. None of the 16 trials had an overall 'low' risk of bias, while four of the trials had a 'high', 'critical', or 'serious' risk of bias. Biases observed in these trials arise from the randomization process, potential deviation from intended interventions, outcome measurements, selective reporting, confounding, participant selection, and/or classification of interventions.

    CONCLUSION: In general, the quality of currently available evidence for the effectiveness of CQ/HCQ in patients with COVID-19 is suboptimal. The importance of a properly designed and reported clinical trial cannot be overemphasized amid the COVID-19 pandemic, and its dismissal could lead to poorer clinical and policy decisions, resulting in wastage of already stretched invaluable health care resources.

    Matched MeSH terms: Randomized Controlled Trials as Topic/standards*
  12. Farzin A, Ibrahim R, Madon Z, Basri H
    Dement Neuropsychol, 2018 7 11;12(2):189-195.
    PMID: 29988335 DOI: 10.1590/1980-57642018dn12-020012
    The surrounding circumstances and environments of Malaysian older adults could make conducting interventions (mainly in terms of clinical or randomized controlled trials) a challenge. Working with older adults and facing cultural issues could be challenging.

    Objective: This paper illustrates a significant perspective of some of the challenges faced while conducting a randomized controlled trial exploring the impact of a multi-component intervention that included strategy- and process-based prospective memory (PM) training among Malaysian older adults.

    Methods: The current study was a randomized controlled trial (RCT) and therefore the challenges were presented in accordance with the CONSORT statement style.

    Results: A discussion on how these issues were addressed is provided.

    Conclusion: Some suggestions were presented to help researchers plan and create interventions for similar studies and to support a practical method of addressing all related challenges.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  13. Sawangjit R, Puttarak P, Saokaew S, Chaiyakunapruk N
    Phytother Res, 2017 Apr;31(4):555-567.
    PMID: 28165166 DOI: 10.1002/ptr.5783
    Cissus quadrangularis L. (Cissus) is a medicinal plant commonly used for centuries for various conditions, but lacks critical appraisal of its clinical effects. This study aimed to determine the efficacy and safety of Cissus in all conditions. Publications from 12 electronic databases were searched from inception through November 2016. A total of nine studies with 1108 patients were included. Each outcome was pooled using a random effects model. Effects of Cissus on hemorrhoid symptoms were not different from any comparators but had significant effects on bone pain. Effects of Cissus combination products on body weight reduction, low-density lipoprotein, triglyceride, total cholesterol, and fasting blood sugar were superior to placebo, with weighted mean difference of -5.19 kg (-8.82, -1.55), -14.43 mg/dl (-20.06, -8.80), -37.50 mg/dl (-48.71, -26.29), -50.50 mg/dl (-70.97, -30.04), and -10.39 mg/dl (-14.60, -6.18), respectively. No serious adverse effects were reported. Quality of evidence based on Grades of Recommendations Assessment Development and Evaluation (GRADE) indicated low (bone fractures) to high quality (hemorrhoids, body weight reduction).In conclusion, Cissus had benefit for bone fractures, but not for hemorrhoids. For obesity/overweight, only combination products are pooled and show benefit. However, high-quality studies remain needed. Copyright © 2017 John Wiley & Sons, Ltd.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  14. Yahaya Mohammed Katagum, Hayati Kadir @ Shahar, Faisal Ibrahim
    Poor diagnosis, treatment and prevention practices had characterised Patent Medicine Vendor (PMV) activities in malaria control despite expectations on their contributions to check the menace. Interventions reversing this situation reduces disease burden and legitimise PMV inclusion in basic healthcare delivery. This study seeks to identify and review studies addressing this priority problem. Steps outlined in PRISMA guidelines were adopted to search and conduct reviews via electronic databases. Randomized trials with intervention effects on PMVs were considered and thirteen articles were ultimately reviewed and narratively evaluated. Analysis of search outputs identified intervention types, methods used, sample sizes, intervention periods, knowledge, attitude and practice variables, other outcomes and listing of priority systematic review topics, using pre-determined criteria. All reviewed studies were found to be effective despite adopting different intervention approaches. Furthermore, identifying and prioritizing reviews greatly improves future malaria interventions and results thereof, thereby maximising opportunities to deliver appropriate and evidence-based healthcare.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  15. Ng KT, Teoh WY
    Prehosp Disaster Med, 2019 Oct;34(5):532-539.
    PMID: 31455452 DOI: 10.1017/S1049023X19004758
    INTRODUCTION: Epinephrine has been recommended for out-of-hospital cardiac arrest (OHCA) resuscitation for nearly one century, but its efficacy and safety remain unclear in the literature. The primary aim of this review was to determine whether epinephrine increases the return of spontaneous circulation in OHCA patients.

    METHODS: A systematic review and meta-analysis were conducted using the following databases: MEDLINE, EMBASE, and CENTRAL, from their inception until October 2018. All the randomized controlled trials (RCTs) were included. Observational studies, case reports, case series, and non-systematic reviews were excluded.

    RESULTS: Two trials including 8,548 patients were eligible for inclusion in the data synthesis. In patients who received epinephrine during OHCA, the incidence of return of spontaneous circulation was increased, with an odds ratio (95%CI) of 4.25 (3.79-4.75), P

    Matched MeSH terms: Randomized Controlled Trials as Topic
  16. Mohammad Farris Iman Leong Abdullah, Mohd Afifuddin Mohamad
    This narrative review present and critically appraise the evidence of psychosocial interventions in enhancing post- traumatic growth (PTG) and spirituality in cancer patients and survivors. A comprehensive search of published En- glish language literatures which include both quantitative and qualitative studies was conducted via Google Scholar, PubMed, Medline, PsycINFO, EMBASE, Cochrane Library, Scopus and Web of Science up to September 2018. Out of an initial 17,000 articles, 10 studies were finally included in the review. There were three randomized controlled trials, two non-randomized comparison trials, three time series/pre and post-intervention designs, one mixed design study and one qualitative study which demonstrated psychosocial interventions enhanced PTG and spirituality in cancer patients and survivors. We concluded mindfulness-based interventions may be promising to enhance PTG and spirituality in cancer patients and survivors. On the contrary, evidence for psycho-spiritual therapy, cancer sup- port group, health behavioural change intervention and individual psychotherapy were lacking and poor.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  17. Nguyen D, Nagendrababu V, Pulikkotil SJ, Rossi-Fedele G
    Aust Endod J, 2020 Aug;46(2):282-294.
    PMID: 31638301 DOI: 10.1111/aej.12380
    The purpose of this systematic review was to assess the effect of occlusal reduction on post-operative pain following root canal treatment and was performed in accordance with the PRISMA statement being registered in the PROSPERO database (CRD42018089941). Two reviewers independently conducted a systematic literature search in the PubMed (MEDLINE), Dentistry & Oral Sciences Source and the Cochrane Library databases. Seven studies were included, of which three were used to perform meta-analysis for 6 days post-operative and the rest for qualitative synthesis. Three studies were assessed as low risk of bias, three as some concern, and one as high risk of bias. Occlusal reduction diminishes the post-operative pain (SMD -1.10 (95%CI -2.06, -0.15) I2  = 96.9%) at 6 days for teeth diagnosed as irreversible pulpitis, and, overall, likely reduces post-operative pain for patients presenting with irreversible pulpitis and/or symptomatic apical periodontitis. Future high-quality clinical trials are needed to better understand the role of occlusal reduction.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  18. Naing C, Whittaker MA, Htet NH, Aye SN, Mak JW
    PLoS One, 2019;14(12):e0225882.
    PMID: 31856172 DOI: 10.1371/journal.pone.0225882
    BACKGROUND: The WHO recommends artemisinin-based combination therapies (ACTs) for the treatment of uncomplicated falciparum malaria. Hence, monitoring the efficacy of antimalarial drugs is a key component of malaria control and elimination. The published randomized trials that assessed comparisons of ACTs for treating uncomplicated falciparum malaria reported conflicting results in treatment efficacy. A network meta-analysis is an extension of pairwise meta-analysis that can synthesize evidence simultaneously from both direct and indirect treatment comparisons. The objective was to synthesize evidence on the comparative efficacy of antimalarial drugs for treatment of uncomplicated falciparum malaria in Asian region.

    METHODS: Relevant randomized trials that assessed efficacy of antimalarial drugs for patients having uncomplicated falciparum malaria in Asian region were searched in health-related databases. We evaluated the methodological quality of the included studies with the Cochrane risk of bias tool. Main outcome was treatment success at day 28 as determined by the absence of parasiteamia. We performed network meta-analysis of the interventions in the trials, and assessed the overall quality of evidence using the GRADE approach.

    RESULTS: Seventeen randomized trials (n = 5043) were included in this network meta-analysis study. A network geometry was formed with 14 antimalarial treatment options such as artemether-lumefantrine (AL), artemisinin-piperaquine, artesunate-amodiaquine, artesunate-mefloquine (ASMQ), artesunate-chloroquine, artesunate-mefloquine home treatment, artesunate-mefloquine 2-day course, artesunate plus sulfadoxine-pyrimethamine, chloroquine, dihydroartemisinin-piperaquine (DHP), dihydroartemisinin-piperaquine home treatment, dihydroartemisinin-piperaquine 4-day course, dihydroartemisinin-piperaquine and added artesunate, sulfadoxine-pyrimethamine. A maximum number of trials included was DHP compared to ASMQ (n = 5). In general, DHP had better efficacy than AL at day 28 (DHP vs AL: OR 2.5, 95%CI:1.08-5.8). There is low certainty evidence due to limited number of studies and small trials.

    DISCUSSION/ CONCLUSIONS: The findings suggest the superiority of DHP (3-day course) to AL and other comparator ACTs are with the overall low/very low quality of evidence judgements. Moreover, one drug regimen is better than another is only if current drug-resistance patterns are at play. For example, the AL might be better than DHP in areas where both artemisinin and piperaquine resistance patterns are prevalent. For substantiation, well-designed larger trials from endemic countries are needed. In the light of benefit versus harm concept, future analysis with safety information is recommended.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  19. Pierot L, Jarayaman M, Szikora I, Hirsch J, Baxter B, Miyachi S, et al.
    Can J Neurol Sci, 2019 05;46(3):269-274.
    PMID: 30890199 DOI: 10.1017/cjn.2019.1
    After five positive randomized controlled trials showed benefit of mechanical thrombectomy in the management of acute ischemic stroke with emergent large-vessel occlusion, a multi-society meeting was organized during the 17th Congress of the World Federation of Interventional and Therapeutic Neuroradiology in October 2017 in Budapest, Hungary. This multi-society meeting was dedicated to establish standards of practice in acute ischemic stroke intervention aiming for a consensus on the minimum requirements for centers providing such treatment. In an ideal situation, all patients would be treated at a center offering a full spectrum of neuroendovascular care (a level 1 center). However, for geographical reasons, some patients are unable to reach such a center in a reasonable period of time. With this in mind, the group paid special attention to define recommendations on the prerequisites of organizing stroke centers providing medical thrombectomy for acute ischemic stroke, but not for other neurovascular diseases (level 2 centers). Finally, some centers will have a stroke unit and offer intravenous thrombolysis, but not any endovascular stroke therapy (level 3 centers). Together, these level 1, 2, and 3 centers form a complete stroke system of care. The multi-society group provides recommendations and a framework for the development of medical thrombectomy services worldwide.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  20. Nagendrababu V, Duncan HF, Bjørndal L, Kvist T, Priya E, Pulikkotil SJ, et al.
    Int Endod J, 2019 Jul;52(7):974-978.
    PMID: 30702139 DOI: 10.1111/iej.13087
    Randomized clinical trials are acknowledged as the most appropriate methodology for demonstrating the efficacy or effectiveness of one intervention as opposed to another and thus play a major role in clinical decision-making. However, it is recognized that despite the existence of various guidelines, for example, the Consolidated Standards for Reporting Trials (CONSORT) statement, the quality of manuscripts describing randomized trials is often suboptimal. The current project aims to develop and disseminate new guidelines, Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE), to improve the planning and reporting quality of randomized trials in the field of Endodontics. The project leads (VN, PD) designed a robust process to develop the PRIRATE guidelines. At first, a steering committee of eight members, including the project leads, was formed. Thereafter, a five-stage consensus process will be followed: initial steps, pre-meeting activities, face-to-face consensus meeting, post-meeting activities and post-publication activities. The steering committee will develop the first draft of the PRIRATE guidelines by identifying relevant and important items from various sources including the CONSORT guidelines and the Clinical and Laboratory Images in Publications (CLIP) principles. This will be followed by the establishment of a PRIRATE Delphi Group (PDG) consisting of 30 members. The individual items of the first draft of the PRIRATE guidelines developed by the steering committee will be evaluated and scored on a 9-point Likert scale by the PDG members. Items with a score of seven and above by more than 70% of PDG members will be included in the second draft of the guidelines, and the Delphi process will be repeated until each item fulfils the set conditions. After obtaining consensus from the PDG, the PRIRATE guidelines will be discussed by 20 selected individuals within a PRIRATE Face-to-face Consensus Meeting Group (PFCMG) to arrive at a final consensus. The final PRIRATE guidelines will be accompanied with an explanation and elaboration document developed by the steering committee and approved by six members, three from the PDG and three from the PFCMG. The PRIRATE guidelines will be published in journals and actively disseminated to educational institutions, national and international academic societies and presented at scientific meetings. The steering committee will periodically revise and update the PRIRATE guidelines based on feedback from stakeholders.
    Matched MeSH terms: Randomized Controlled Trials as Topic
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