Displaying publications 1 - 20 of 363 in total

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  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. Lai NM, Leom DYX, Chow WL, Chen KH, Lin PH, Chaiyakunapruk N, et al.
    Neonatology, 2020;117(4):428-435.
    PMID: 32209794 DOI: 10.1159/000506703
    BACKGROUND: Research findings based on patient-important outcomes (PIOs) provide more useful conclusions than those that are based on surrogate outcomes. It is unclear to what extent PIOs are represented in neonatal randomized controlled trials (RCTs).

    OBJECTIVES: We determined the proportion of PIOs in neonatal RCTs included in Cochrane Neonatal reviews.

    METHODS: We extracted up to 5 outcomes from each RCT included in Cochrane Neonatal reviews published until January 2018, with independent determination of PIOs among authors followed by a discussion leading to a consensus. We defined PIOs as outcomes that matter to patient care, such as clinical events or physiological or laboratory parameters that are widely used to guide management.

    RESULTS: Among 6,832 outcomes extracted from 1,874 RCTs included in 276 reviews, 5,349 (78.3%) were considered PIOs; 461 studies (24.5%) included 5 or more PIOs, 1,278 (68.2%) included 1-4 PIOs, while 135 (7.2%) had no PIO included. PIOs were observed more often among dichotomous than among continuous outcomes (94.9 vs. 61.5%; RR: 1.54; 95% CI: 1.50-1.58), and more among subjective than among objective outcomes (95.9 vs. 76.8%; RR: 1.25; 95% CI: 1.22-1.28). Newer studies were more likely to have a greater number of PIOs (adjusted OR: 1.033 [95% CI: 1.025-1.041] with each publication year).

    CONCLUSIONS: The large and increasing representation of PIOs over the years suggests an improving awareness by neonatal trialists of the need to incorporate important outcomes in order to justify the utilization of resources. Further research should explore the reasons for non-inclusion or non-reporting of PIOs in a small proportion of RCTs.

    Matched MeSH terms: Randomized Controlled Trials as Topic*
  4. 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
  5. 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
  6. 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
  7. 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
  8. Al-Rudayni AHM, Gopinath D, Maharajan MK, Veettil SK, Menon RK
    PMID: 34299869 DOI: 10.3390/ijerph18147418
    Oral mucositis is a debilitating complication of chemotherapy, characterized by erythema, ulcers and oedema of the oral mucosa. This review aimed to evaluate the efficacy of Photobiomodulation in the treatment of oral mucositis using meta-analysis and trial sequential analysis, and also to assess the quality of the results by Grading of Recommendations, Assessment, Development and Evaluation (GRADE). A comprehensive search of three databases, including Embase, Medline and Central, was performed to identify randomized controlled trials studying the efficacy of Photobiomodulation in the treatment of cancer chemotherapy-induced oral mucositis. The primary outcome was reduction in the severity of oral mucositis. Secondary outcomes were pain relief, duration of oral mucositis and adverse effects. The meta-analysis was performed using the random-effects model, and random errors of the meta-analyses were detected by trial sequential analysis. A total of 6 randomized controlled trials with 398 participants were included in our analysis. Photobiomodulation significantly reduced the severity of oral mucositis when compared to sham radiation (RR 0.43, 95% CI 0.20 to 0.93; p < 0.05). Sensitivity analysis by excluding trials with high risk of bias reiterated the robustness of our results (RR 0.28, 95% CI 0.16 to 0.48). Trial sequential analysis illustrated that the evidence from the meta-analysis was conclusive. The result of the meta-analyses with trial sequential analysis illustrated that Photobiomodulation is an effective therapeutic intervention for the treatment of oral mucositis, and the evidence gathered can be considered conclusive with a moderate level of certainty according to GRADE. Further trials are recommended to standardize the laser parameters required for the optimal effect.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  9. Ali AS, Hasan SS, Kow CS, Merchant HA
    Clin Nutr ESPEN, 2021 10;45:26-32.
    PMID: 34620326 DOI: 10.1016/j.clnesp.2021.08.019
    BACKGROUND: Lactoferrin (Lf) is one of the key immunomodulatory substances found naturally in various body fluids, such as saliva, tears, and breast milk, and forms a vital part of the innate defense against invading pathogens. Various studies have demonstrated antibacterial, antifungal, and antiviral properties of Lf and its protective role against respiratory tract infections (RTIs). The present meta-analysis aims to elucidate the association of Lf administration in reducing the risk of RTIs by systematically reviewing the data from randomized controlled trials (RCTs).

    METHODS: We systematically searched PubMed, Cochrane Library, Medline & CINAHL, Turning Research into Practice (TRIP), ProQuest Theses & Dissertations Databases, and China National Knowledge Infrastructure (CNKI) from inception till March 15, 2021. The primary outcome measure was a reduction in respiratory illness; decrease in frequency, symptoms, and duration. Random-effects model was used to estimate the odds ratio (OR) and 95% confidence interval (CI). We used Cochrane's RoB-2 to appraise the risk of bias of included RCTs.

    RESULTS: A total of nine RCTs were eligible for this review, of which six were included in the meta-analysis. Overall, two studies demonstrated a high risk of bias. The meta-analysis revealed a significantly reduced odds of developing respiratory infections with the use of Lf relative to the control (pooled odds ratio = 0.57; 95% confidence interval 0.44 to 0.74, n = 1,194), with sufficient evidence against the hypothesis of 'no significant difference' at the current sample size.

    CONCLUSIONS: The administration of Lf shows promising efficacy in reducing the risk of RTIs. Current evidence also favours Lf fortification of infant formula. Lf may also have a beneficial role in managing symptoms and recovery of patients suffering from RTIs and may have potential for use as an adjunct in COVID-19, however this warrants further evidence from a large well-designed RCT.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  10. 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*
  11. 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*
  12. 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*
  13. 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*
  14. 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*
  15. 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
  16. Dikeocha IJ, Al-Kabsi AM, Hussin S, Alshawsh MA
    BMJ Open, 2020 08 07;10(8):e038128.
    PMID: 32771989 DOI: 10.1136/bmjopen-2020-038128
    INTRODUCTION: Colorectal cancer is one of the leading causes of cancer-related morbidity worldwide and it has been reported to be associated with poor lifestyle habits which include excess tobacco and alcohol intake as well as genetics and age factors. Probiotics such as the lactic acid bacteria and Bifidobacterium as well as probiotic containing foods (kombucha, kefir, miso etc) have received lots of attention as anticancer agents for prevention and treatment. The effects of the administration of probiotics to patients with colorectal cancer is the primary goal of this systematic review. The overall aim is to assess how the use of probiotics in patients with colorectal cancer helps in the management of colorectal cancer and its effect on the diversity of gut microbiota. The final systematic review will provide a comprehensive evidence base for the use and efficacy of probiotics in patient with colorectal cancer care.

    METHODS AND ANALYSIS: The systematic review, will be conducted by extensively searching different databases such as PubMed, Web of Science, Scopus, Wiley and ProQuest to identify randomised controlled trials (with no time frame) which relate to the administration of probiotics to patients with colorectal cancer. The search strategy will include words like colorectal cancer, probiotics, Bifidobacterium, clinical trials etc. A systematic search of databases was performed between 17 and 20 January 2020. Two reviewers will independently review the studies and also search the reference lists of the eligible studies to obtain more references. Data will be extracted from the eligible studies using standardised data extraction form. After assessing the risk of bias, qualitative analysis will be used to synthesise the systematic review.

    ETHICS AND DISSEMINATION: This is a protocol for a systematic review; therefore, it doesn't require any ethics approval. We intend to disseminate the protocol in a peer reviewed journal.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  17. Vasantha Kumar P, Subramaniam P, Che Din N
    Asian J Psychiatr, 2021 Jun;60:102646.
    PMID: 33873045 DOI: 10.1016/j.ajp.2021.102646
    BACKGROUND: The effects of aging and its associated cognitive decline is particularly acute in Asia given the exponential growth of older adults as a proportion of the population as a whole. Many structured cognitive interventions have been proposed to prevent the cognitive decline typically seen in older age, but their utility as a viable means of achieving these goals is questionable.

    OBJECTIVES: To summarize and synthesize evidence on the utility and methodological quality of cognitive-based interventions on cognitive performance and associated secondary outcomes among healthy older adults in Asia, as well as novel, culture-specific components of cognitive interventions across the region.

    DATA SOURCES: The PubMed/Medline, Web of Science, Scopus, and ScienceDirect databases were searched through May 2020.

    ELIGIBILITY: Studies including individuals aged 60 years and above, who had no previous history of physical and/or mental illness. Few restrictions placed on intervention design, duration and mode of delivery, provided that participants were randomized to study conditions, and intervention included components addressing at least one cognitive domain.

    RESULTS: A total of 17 studies from six countries met the eligibility criteria and were included in the final review. Evidence from those studies indicated that cognitive interventions may be most effective when the design and aims were directed towards improvement in specific cognitive domains, but evidence regarding long-term effectiveness in preventing progression to clinical-level cognitive deficits is still unclear. Several studies highlighted culture-specific activities as components of their interventions, though these will need to be further outlined and standardized clearly in future research.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  18. Sereda M, McFerran D, Axon E, Baguley DM, Hall DA, Potgieter I, et al.
    Int J Audiol, 2020 08;59(8):640-646.
    PMID: 32134348 DOI: 10.1080/14992027.2020.1733677
    Objective: To develop an innovative prioritisation process to identify topics for new or updated systematic reviews of tinnitus research.Design: A two-stage prioritisation process was devised. First, a scoping review assessed the amount of randomized controlled trial-level evidence available. This enabled development of selection criteria for future reviews, aided the design of template protocol and suggested the scale of work that would be required to conduct these reviews. Second, using the pre-defined primary and secondary criteria, interventions were prioritised for systematic review.Study sample: Searches identified 1080 records. After removal of duplicates and out of scope works, 437 records remained for full data charting.Results: The process was tested, using subjective tinnitus as the clinical condition and using Cochrane as the systematic review platform. The criteria produced by this process identified three high priority reviews: (1) Sound therapy using amplification devices and/or sound generators; (2) Betahistine and (3) Cognitive behaviour therapy. Further secondary priorities were: (4) Gingko biloba, (5) Anxiolytics, (6) Hypnotics, (7) Antiepileptics and (8) Neuromodulation.Conclusions: A process was developed which successfully identified priority areas for Cochrane systematic reviews of interventions for subjective tinnitus. This technique could easily be transferred to other conditions and other types of systematic reviews.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  19. Lai NM, Yap AQY, Ong HC, Wai SX, Yeo JHH, Koo CYE, et al.
    Neonatology, 2021;118(3):259-263.
    PMID: 33780936 DOI: 10.1159/000514402
    INTRODUCTION: Composite outcomes are used to increase the power of a study by combining event rates. Many composite outcomes in adult clinical trials have components that differ substantially in patient importance, event rate, and effect size, making interpretation challenging. Little is known about the use of composite outcomes in neonatal randomized controlled trials (RCTs).

    METHODS: We assessed the use of composite outcomes in neonatal RCTs included in Cochrane Neonatal reviews published till November 2017. Two authors reviewed the components of the composite outcomes to compare their patient importance and computed the ratios of effect sizes and event rates between the components, with an a priori threshold of 1.5, indicating a substantial difference. Descriptive statistics were presented.

    RESULTS: We extracted 7,766 outcomes in 2,134 RCTs in 312 systematic reviews. Among them, 55 composite outcomes (0.7%) were identified in 46 RCTs. The vast majority (92.7%) of composite outcomes had 2 components, with death being the most common component (included 51 times [92.7%]). The components in nearly three-quarters of the composite outcomes (n = 40 [72.7%]) had different patient importance, while the effect sizes and event rates differed substantially between the components in 27 (49.1%) and 35 (63.6%) outcomes, respectively, with up to 43-fold difference in the event rates observed.

    CONCLUSIONS: The majority of composite outcomes in neonatal RCTs had different patient importance with contrasting effect sizes and event rates between the components. In patient communication, clinicians should highlight individual components, rather than the composites, with explanation on the relationship between the components, to avoid misleading impression on the effect of the intervention. Future trials should report the estimates of all individual components alongside the composite outcomes presented.

    Matched MeSH terms: Randomized Controlled Trials as Topic
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