Relevant bibliographies by topics / Trial Sequential Analysis

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  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers
  6. Reports

Academic literature on the topic 'Trial Sequential Analysis'

Author: Grafiati
Published: 4 June 2025
Last updated: 23 June 2025

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Journal articles on the topic "Trial Sequential Analysis"

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Leonardi-Bee, J. "Trial Sequential Analysis." International Journal of Evidence-Based Healthcare 14, no. 4 (2016): 194. http://dx.doi.org/10.1097/01.xeb.0000511335.64918.e6.

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Yang, Shengping, and Gilbert Berdine. "Trial sequential analysis." Southwest Respiratory and Critical Care Chronicles 11, no. 47 (2023): 63–67. http://dx.doi.org/10.12746/swrccc.v11i47.1175.

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Chai-Adisaksopha, Chatree, Kristian Thorlund, and Alfonso Iorio. "Interpreting trial sequential analysis." Transfusion 56, no. 12 (2016): 2918–22. http://dx.doi.org/10.1111/trf.13910.

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Kang, Hyun. "Trial sequential analysis: novel approach for meta-analysis." Anesthesia and Pain Medicine 16, no. 2 (2021): 138–50. http://dx.doi.org/10.17085/apm.21038.

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Systematic reviews and meta-analyses rank the highest in the evidence hierarchy. However, they still have the risk of spurious results because they include too few studies and participants. The use of trial sequential analysis (TSA) has increased recently, providing more information on the precision and uncertainty of meta-analysis results. This makes it a powerful tool for clinicians to assess the conclusiveness of meta-analysis. TSA provides monitoring boundaries or futility boundaries, helping clinicians prevent unnecessary trials. The use and interpretation of TSA should be based on an understanding of the principles and assumptions behind TSA, which may provide more accurate, precise, and unbiased information to clinicians, patients, and policymakers. In this article, the history, background, principles, and assumptions behind TSA are described, which would lead to its better understanding, implementation, and interpretation.
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Barakji, Jehad, Steven Kwasi Korang, Joshua Feinberg, et al. "Cannabinoids versus placebo for pain: A systematic review with meta-analysis and Trial Sequential Analysis." PLOS ONE 18, no. 1 (2023): e0267420. http://dx.doi.org/10.1371/journal.pone.0267420.

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Objectives To assess the benefits and harms of cannabinoids in participants with pain. Design Systematic review of randomised clinical trials with meta-analysis, Trial Sequential Analysis, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Data sources The Cochrane Library, MEDLINE, Embase, Science Citation Index, and BIOSIS. Eligibility criteria for selecting studies Published and unpublished randomised clinical trials comparing cannabinoids versus placebo in participants with any type of pain. Main outcome measures All-cause mortality, pain, adverse events, quality of life, cannabinoid dependence, psychosis, and quality of sleep. Results We included 65 randomised placebo-controlled clinical trials enrolling 7017 participants. Fifty-nine of the trials and all outcome results were at high risk of bias. Meta-analysis and Trial Sequential Analysis showed no evidence of a difference between cannabinoids versus placebo on all-cause mortality (RR 1.20; 98% CI 0.85 to 1.67; P = 0.22). Meta-analyses and Trial Sequential Analysis showed that cannabinoids neither reduced acute pain (mean difference numerical rating scale (NRS) 0.52; 98% CI -0.40 to 1.43; P = 0.19) or cancer pain (mean difference NRS -0.13; 98% CI -0.33 to 0.06; P = 0.1) nor improved quality of life (mean difference -1.38; 98% CI -11.81 to 9.04; P = 0.33). Meta-analyses and Trial Sequential Analysis showed that cannabinoids reduced chronic pain (mean difference NRS -0.43; 98% CI -0.72 to -0.15; P = 0.0004) and improved quality of sleep (mean difference -0.42; 95% CI -0.65 to -0.20; P = 0.0003). However, both effect sizes were below our predefined minimal important differences. Meta-analysis and Trial Sequential Analysis indicated that cannabinoids increased the risk of non-serious adverse events (RR 1.20; 95% CI 1.15 to 1.25; P < 0.001) but not serious adverse events (RR 1.18; 98% CI 0.95 to 1.45; P = 0.07). None of the included trials reported on cannabinoid dependence or psychosis. Conclusions Cannabinoids reduced chronic pain and improved quality of sleep, but the effect sizes are of questionable importance. Cannabinoids had no effects on acute pain or cancer pain and increased the risks of non-serious adverse events. The harmful effects of cannabinoids for pain seem to outweigh the potential benefits.
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Al-Rudayni, Ali Hatem Manfi, Divya Gopinath, Mari Kannan Maharajan, Sajesh K. Veettil, and Rohit Kunnath Menon. "Efficacy of Photobiomodulation in the Treatment of Cancer Chemotherapy-Induced Oral Mucositis: A Meta-Analysis with Trial Sequential Analysis." International Journal of Environmental Research and Public Health 18, no. 14 (2021): 7418. http://dx.doi.org/10.3390/ijerph18147418.

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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.
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Alfirevic, Z., and S. Gates. "Trial sequential analysis: useful or useless?" BJOG: An International Journal of Obstetrics & Gynaecology 127, no. 10 (2020): 1227–28. http://dx.doi.org/10.1111/1471-0528.16282.

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Kulinskaya, Elena, and John Wood. "Trial sequential methods for meta-analysis." Research Synthesis Methods 5, no. 3 (2013): 212–20. http://dx.doi.org/10.1002/jrsm.1104.

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Geller, N. L. "Planned interim analysis and its role in cancer clinical trials." Journal of Clinical Oncology 5, no. 9 (1987): 1485–90. http://dx.doi.org/10.1200/jco.1987.5.9.1485.

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Although interim analyses in cancer clinical trials are commonplace, clinical trials are usually designed with the implicit assumption that data analysis will occur only after the trial is completed. The design of randomized trials with planned interim analyses, "group sequential trials," is described and examples are given. A method to redesign trials in which unplanned interim analyses have been undertaken is described. Planned interim analysis should be considered whenever a cancer clinical trial is designed.
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Maurya, Indubala, Ayush Lohiya, and Ashish Solanki. "Trial sequential analysis: Quality improvement for meta-analysis." Indian Journal of Anaesthesia 68, no. 12 (2024): 1092–94. https://doi.org/10.4103/ija.ija_1051_24.

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Dissertations / Theses on the topic "Trial Sequential Analysis"

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CASTELLINI, GRETA. "INVESTIGATING INNOVATIVE EVIDENCE SYNTHESIS METHODS: THE TRIAL SEQUENTIAL ANALYSIS, THE GRADE SYSTEM AND THE NETWORK META-ANALYSIS." Doctoral thesis, Università degli Studi di Milano, 2019. http://hdl.handle.net/2434/672084.

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Le revisioni sistematiche e meta-analisi sono i migliori disegni di studio per assistere il processo decisionale in ambito clinico. Pazienti, clinici, ricercatori e decisori politici dovrebbero privilegiare la revisione sistematica rispetto a altri tipi di disegno sperimentale in quanto permette di aggregare diversi studi primari contemporaneamente, incrementando la validità interna ed esterna dei risultati. Inoltre, la meta-analisi aumenta la validità statistica raggiungendo più alti livelli di potenza statistica e precisione rispetto ai singoli studi. Ciò significa comprendere meglio la grandezza dell’effetto del trattamento e identificare il miglior intervento tra due, nel caso di meta-analisi standard, o tra molteplici, nel caso di network meta-analisi. Nonostante i numerosi vantaggi sopra riportati, la meta-analisi ha delle limitazioni importanti. La potenza e la precisione, infatti, dipendono da diversi elementi quali la dimensione campionaria degli studi, il numero di eventi, la variabilità del campione e la relativa eterogeneità. Questi elementi sono condizioni imprescindibili e non modificabili dai revisori. Se uno o più di questi elementi sono problematici, la meta-analisi replicherà lo stesso problema, sebbene l’entità del problema stesso può diminuire grazie alla presenza di altri studi. Per esempio, le meta-analisi che includono studi con una numerosità campionaria molto bassa saranno più propensi a diversi bias, quali lo small study effect e il publication bias. Inoltre molti studi clinici si propongo di ricercare modesti effetti di un intervento, che, generalmente, sono difficili da identificare: infatti, anche limitate variazioni nei dati di uno studio, o tra uno studio e un altro, possono risultare in bias che nascondono o alterano gli effetti di un intervento. Alla luce di questo background, la prima domanda di ricerca si è focalizzata sull’adeguatezza del reporting degli studi randomizzati e controllati inclusi in revisioni sistematiche e meta-analisi, in particolare in termini di potenza statistica, rilevanza clinica e conclusività dei risultati. In secondo luogo, sono stati analizzati metodi innovativi per identificare e valutare meta-analisi sotto-potenziate, inconclusive e imprecise: tali metodi includono la Trial Sequential Analysis e il metodo GRADE (Grading of Recommendations Assessment, Development and Evaluation). Infine, è stata studiata e applicata una nuova tecnica meta-analitica per confrontare allo stesso tempo interventi multipli tra loro considerando sia l’evidenza diretta sia l’evidenza indiretta. Al fine di rispondere alle domande di ricerca proposte, si è passati dall’unità di analisi delle revisioni sistematiche, lo studio randomizzato e controllato, ai metodi di sintesi cumulativa delle evidenze. Il reporting inadeguato, le meta-analisi sotto-potenziate e le possibili discordanze tra evidenze dirette e indirette a partire dall’analisi dei confronti testa-a-testa, possono alterare le decisioni cliniche portando a errori se viene meno un’attenta disamina e ci si basa su un’analisi statistica grossolana. La presente tesi è organizzata in tre sezioni principali: - Sezione 1: è stata valutato come il calcolo della dimensione campionaria sia stato riportato negli studi randomizzati e controllati che valutano l’efficacia di interventi riabilitativi nella lombalgia e, tra gli studi adeguatamente riportati, come i risultati siano interpretati in termini di significatività statistica e rilevanza clinica. - Sezione 2: sono state descritte, analizzate e applicate in diverse aree cliniche la Trial Sequential Analysis (TSA) e il metodo GRADE. Inoltre, è stata comparata la loro concordanza nel valutare e giudicare la qualità dell’evidenza. - Sezione 3: infine, considerato un campione di studi randomizzati e controllati che valutano l’efficacia di interventi riabilitativi e farmacologici per la lombalgia, sono state combinate le evidenze dirette e indirette esistenti tramite la tecnica di network meta-analisi. Il focus di questa tesi è orientato ai metodi avanzati ed innovativi di sintesi delle evidenze. L’introduzione e applicazione di questi metodi rappresentano la necessità di rispondere al recente bisogno di risultati precisi e affidabili, a metodi trasparenti e di riferimento per valutare la qualità e affidabilità dell’evidenza, e alla necessità di confrontare numerosi interventi senza limitarsi a confronti binari.<br>Systematic reviews and meta-analysis are the most appropriate and preferred study designs to inform clinical decision-making. Patients, clinicians, researchers and policymakers rely on this type of design since it aggregates several studies at the same time, increasing internal and external validity. Furthermore meta-analyses can increase statistical validity, reaching higher levels of power and precision as compared to single studies. This often means better understanding the magnitude of the treatment effect and its uncertainty therefore identifying the best intervention in pairwise or network (multiple) comparisons. Despite these advantages, meta-analyses also have limitations and shortcomings. Power and precision depend on several elements, such as size of studies, number of events, sample variability and underlying heterogeneity. These elements are precondition and cannot be modified by reviewers. If one or more of these elements are problematic, the meta-analysis will replicate the same problem, despite the severity of the problem might be diminished by the co-presence of multiple studies. For instance meta-analyses including several small studies will be prone to several biases, eg, small study effect and publication biases. Moreover actual studies often explore modest intervention effects, which are difficult to be identified: even limited perturbations of study data can result in biases that can hide or inflate intervention effects, sabotaging the decision-making process of health professionals. Against this background, we first wondered if RCTs included in systematic reviews and meta-analysis are adequately reported in terms of power and relevance/conclusiveness of findings. Secondly we explored how detect and assess underpowered, inconclusive and imprecise meta-analyses, using and comparing two modern approaches - Trial Sequential Analysis and the GRADE (Grading of Recommendations Assessment, Development and Evaluation). Third, we explored new meta-analytic techniques to contrast multiple interventions through direct and indirect evidence, in an extreme attempt to solve major limitations of a priori literature and lack of head to head trials. In order to answer these research questions, we moved from the unit of analysis of systematic reviews, the randomized controlled trial, to the methods to accumulate evidence. Inadequate reporting, underpowered meta-analyses and conflicting direct and indirect evidence beyond head-to-head comparisons can alter the clinical decision-making process unless proper assessment, analysis and critical interpretation are put in place. My dissertation is organized in three main Sections: - Section 1: We focused on how sample size calculations were reported in RCTs exploring the efficacy of low back pain rehabilitation interventions and, among those adequately reported, how findings were interpreted in terms of statistical significance and clinical relevance. - Section 2: We explored Trial Sequential Analysis and the GRADE approach in several medical areas. We compared the agreement of the approaches in evaluating the overall quality of evidence. - Section 3. We finally combined direct and indirect evidence on a sample of RCTs assessing rehabilitation interventions for low back pain through a network meta-analysis. This dissertation focuses on innovative advanced methods used in evidence synthesis science. These methods are partial answers to the need for precise and reliable results, standard and transparent methods to assess the body of evidence, and comparisons of multiple interventions in addition to pairwise comparisons.
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Schwimmbeck, Franz [Verfasser], and Leopold [Akademischer Betreuer] Eberhart. "Hypertone Kochsalzlösungen in der Therapie des Schädel-Hirn-Traumas und des traumatisch hämorrhagischen Schocks - Systematische Übersichtsarbeit und Metaanalyse mit Trial Sequential Analysis / Franz Schwimmbeck ; Betreuer: Leopold Eberhart." Marburg : Philipps-Universität Marburg, 2021. http://d-nb.info/1239239904/34.

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Todd, Susan Clare. "Methods of analysis for sequential clinical trials." Thesis, University of Reading, 1994. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.239477.

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Morgan, Caroline Claire. "Group sequential response adaptive designs for clinical trials." Thesis, University of Sussex, 2003. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.288791.

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A recently developed group-sequential response-adaptive design to compare two treatments with immediate normally distributed responses and known variances is considered. The power function of the test is the same as that under non-adaptive sampling, and significant decreases in the inferior treatment number can be achieved with only minor increases in the average sample number. Reasonably accurate corrected confidence intervals for both the treatment mean difference and the individual means are obtained by constructing approximately pivotal quantities. An approximation to the bias of the maximum likelihood estimator of the treatment mean difference is also studied. When the variances of the response variables are unknown, inaccurate estimates of these can affect the Type II error rate considerably. A new modified version of an existing sample size re-estimation method is developed for group-sequential response-adaptive designs for normal data with unknown variances. The principal modifications involve updating the required sample size at each interim analysis and calculating the test statistic based on current estimates of the variances. Simulation is used to compare the performance of this test with modified versions of two other tests from the recent literature. The power is shown to be more accurately maintained in the new test. An analogous group-sequential response-adaptive design to compare two treatments with immediate dichotomous responses is then developed. Since the variances of the response variables are unknown in binary response trials, due to their dependence on the unknown success probabilities, the new sample size re-estimation method is incorporated into the design. Two parameters of interest are considered, the log odds ratio and the simple difference between the probabilities of success. Three adaptive urn models are studied and their properties are compared to a sequential maximum likelihood estimation rule that minimises the expected number of treatment failures. Simulation results favour the drop-the-loser rule
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Blatchford, Patrick Judson. "Monitoring bivariate endpoints in group sequential clinical trials /." Connect to full text via ProQuest. Limited to UCD Anschutz Medical Campus, 2007.

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Thesis (Ph.D. in Biostatistics) -- University of Colorado Denver, 2007.<br>Typescript. Includes bibliographical references (leaves 104-106). Free to UCD affiliates. Online version available via ProQuest Digital Dissertations;
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Facey, Karen Maria. "Sequential procedures for clinical trials design, monitoring and analysis." Thesis, University of Reading, 1991. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.315536.

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Rojas, Cordova Alba Claudia. "Resource Allocation Decision-Making in Sequential Adaptive Clinical Trials." Diss., Virginia Tech, 2017. http://hdl.handle.net/10919/86348.

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Adaptive clinical trials for new drugs or treatment options promise substantial benefits to both the pharmaceutical industry and the patients, but complicate resource allocation decisions. In this dissertation, we focus on sequential adaptive clinical trials with binary response, which allow for early termination of drug testing for benefit or futility at interim analysis points. The option to stop the trial early enables the trial sponsor to mitigate investment risks on ineffective drugs, and to shorten the development time line of effective drugs, hence reducing expenditures and expediting patient access to these new therapies. In this setting, decision makers need to determine a testing schedule, or the number of patients to recruit at each interim analysis point, and stopping criteria that inform their decision to continue or stop the trial, considering performance measures that include drug misclassification risk, time-to-market, and expected profit. In the first manuscript, we model current practices of sequential adaptive trials, so as to quantify the magnitude of drug misclassification risk. Towards this end, we build a simulation model to realistically represent the current decision-making process, including the utilization of the triangular test, a widely implemented sequential methodology. We find that current practices lead to a high risk of incorrectly terminating the development of an effective drug, thus, to unrecoverable expenses for the sponsor, and unfulfilled patient needs. In the second manuscript, we study the sequential resource allocation decision, in terms of a testing schedule and stopping criteria, so as to quantify the impact of interim analyses on the aforementioned performance measures. Towards this end, we build a stochastic dynamic programming model, integrated with a Bayesian learning framework for updating the drug’s estimated efficacy. The resource allocation decision is characterized by endogenous uncertainty, and a trade-off between the incentive to establish that the drug is effective early on (exploitation), due to a time-decreasing market revenue, and the benefit from collecting some information on the drug’s efficacy prior to committing a large budget (exploration). We derive important structural properties of an optimal resource allocation strategy and perform a numerical study based on realistic data, and show that sequential adaptive trials with interim analyses substantially outperform traditional trials. Finally, the third manuscript integrates the first two models, and studies the benefits of an optimal resource allocation decision over current practices. Our findings indicate that our optimal testing schedules outperform different types of fixed testing schedules under both perfect and imperfect information.<br>Ph. D.
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Öhrn, Carl Fredrik. "Group sequential and adaptive methods : topics with applications for clinical trials." Thesis, University of Bath, 2011. https://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.538283.

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This thesis deals with sequential and adaptive methods for clinical trials, and how such methods can be used to achieve efficient clinical trial designs. The efficiency gains that can be achieved through non-adaptive group sequential methods are well established, while the newer adaptive methods seek to combine the best of the classical group sequential framework with an approach that gives increased flexibility. Our results show that the adaptive methods can provide some additional efficiency, as well as increased possibilities to respond to new internal and external information. Care is however needed when applying adaptive methods. While sub-optimal rules for adaptation can lead to inefficiencies, the logistical challenges can also be considerable. Efficient non-adaptive group sequential designs are often easier to implement in practice, and have for the cases we have considered been quite competitive in terms of efficiency. The four problems that are presented in this thesis are very relevant to how clinical trials are run in practice. The solutions that we present are either new approaches to problems that have not previously been solved, or methods that are more efficient than the ones currently available in the literature. Several challenging optimisation problems are solved through numerical computations. The optimal designs that are achieved can be used to benchmark new methods proposed in this thesis as well as methods available in the statistical literature. The problem that is solved in Chapter 5 can be viewed as a natural extension to the other problems. It brings together methods that we have used to the design of individual trials, to solve the more complex problem of designing a sequence of trials that are the core part of a clinical development program. The expected utility that is maximised is motivated by how the development of new medicines works in practice.
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Gillen, Daniel L. "The use of weighted logrank statistics in group sequential testing and non-proportional hazards /." Thesis, Connect to this title online; UW restricted, 2003. http://hdl.handle.net/1773/9557.

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Alharbi, Ghaleb. "Evidence-based medicine in neuropathic pain : a systematic review, meta-analysis, sequential analysis and network meta-analysis of randomised controlled trials." Thesis, University of Nottingham, 2018. http://eprints.nottingham.ac.uk/55427/.

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Background Many randomised controlled trials (RCTs) are available to support using different pharmacotherapy agents in the management of various neuropathic pain conditions. However, choosing these pharmacotherapy agents for neuropathic pain is challenging, due to the limited evidence-based knowledge to support the use of different pharmacotherapy agents in different neuropathic pain conditions. Aims The aim of this PhD is to evaluate the efficacy and safety of oral and topical pharmacotherapies for managing neuropathic pain by deriving placebo and active comparative efficacy and safety evidence from RCTs. Methods This research used three approaches to summarise and synthesise evidence from randomised controlled studies including: a systematic review of placebo and active control RCTs to summarise and criticise the current evidence in neuropathic pain; a meta-analysis and sequential analysis of eligible studies to provide a more precise estimate of the overall treatment effects; and a network meta-analysis to estimate the relative effectiveness of the most commonly used interventions in neuropathic pain. Results Systematic review Two hundred placebo and active-controlled trials met the inclusion criteria. A wide range of different treatments were studied in these trials, including anticonvulsants, antidepressants, opioids and topical capsaicin and lidocaine. Most of the included studies were parallel placebo-controlled trials and commonly lasted for 3 to 12 weeks. In addition, the vast majority of the included RCTs were conducted in participants with painful diabetic neuropathy and post-herpetic neuralgia, while only a few trials were conducted in participants with central neuropathic pain conditions. Pairwise meta-analysis Sixty seven trials were eligible for the pairwise meta analysis of efficacy outcomes. Of the anticonvulsants group pregabalin and gabapentin compared with placebo demonstrated efficacy for 50% and 30% pain reduction and global improvement in patients with neuropathic pain. The efficacy of anticonvulsants varied in different types of neuropathic pain. Gabapentin when compared against a placebo was better than a placebo in PHN and PDN, while pregabalin was significantly effective in patients with post-herpetic neuralgia (PHN) and painful diabetic neuropathy (PDN) but not in patients with HIV associated neuropathic pain. Others anticonvulsant agents, such as lamotrigine, valproic acid, topiramate, levetiracetam and oxcarbazepine, were tested in a small number of trials. These did not provide useful benefits compared with a placebo for a 50% and 30% pain reduction. Of the antidepressant group, duloxetine when compared to a placebo demonstrated efficacy for 50% and 30% pain reduction in diabetic neuropathic pain. A few active comparison trials failed to demonstrate superior efficacy of one drug over another for a 50% and 30% reduction in neuropathic pain. Trial sequential analysis To examine the reliability and conclusiveness of the available evidence, trialsequential analysis has been applied in this study. The results show convincing evidence of the efficacy of some interventions (e.g. pregabalin, gabapentin and duloxetine) to reduce pain by 50% in some neuropathic pain conditions (e.g. diabetic neuropathic pain and post-herpetic neuralgia). The continuation of RCTs of pregabalin and duloxetine in diabetic neuropathy and gabapentin in post-herpetic neuralgia is not necessary as there appears to be sufficient evidence of the efficacy of these treatments in the management diabetic neuropathic pain and post herpetic neuralgia. Further RCTs of duloxetine, pregabalin and gabapentin are however required for central neuropathic pain. In contrast, the analysis failed to provide evidence that opioids and high concentration capsaicin demonstrate a 50% pain reduction. Network meta-analysis Twenty-eight trials were eligible for the network meta-analysis. The results incorporating both direct-comparison and indirect-comparison evidence suggested that there is no superiority of duloxetine over amitriptyline, pregabalin and gabapentin in achieving at least a 30% and 50% pain reduction with a treatment duration of 7 to 12 weeks in patients with neuropathic pain conditions, such as diabetic neuropathic pain, postherpetic neuralgia and spinal cord injury. Conclusions In summary, this research has found that some good quality trials provide good evidence regarding the efficacy of duloxetine, pregabalin and gabapentin in a minority of patients with neuropathic pain. Until advancements in developing mechanism-based approaches and improved clinical trial design become available, the routine use of these medications is unlikely to be changed. This may support the hypothesis that traditional RCTs might not be a suitable method of choice to address provisional health questions in routine clinical practice.
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Books on the topic "Trial Sequential Analysis"

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Zhong, Xiaobo. Design and Analysis of Sequential Multiple Assignment Randomized Trial for Comparing Multiple Adaptive Interventions. [publisher not identified], 2018.

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Duan-Zheng, Xu. Computer analysis of sequential medical trials. Horwood, 1990.

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Hsü, Tuan-cheng. Computer analysis of sequential medical trials. Ellis Horwood, 1990.

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Bartroff, Jay. Sequential experimentation in clinical trials: Design and analysis. Springer, 2013.

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John, Whitehead. The design and analysis of sequential clinical trials. 2nd ed. J. Wiley & Sons, 1997.

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1941-, Peace Karl E., ed. Biopharmaceutical sequential statistical applications. M. Dekker, 1992.

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Elwood, Mark. Critical appraisal of a randomized trial of a preventive agent. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780199682898.003.0013.

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This chapter presents an important, large, international randomised trial of prevention, the use of folic acid and multivitamins in preventing spina bifida and other neural tube defects. This shows the ethical and logistic issues involved, a factorial randomised design, a sequential analysis and early stopping example, and specificity of effect, and discusses the application to policy. 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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Computer Analysis of Sequential Medical Trials. Prentice Hall, 1990.

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Shih, Mei-Chiung, Tze Leung Lai, and Jay Bartroff. Sequential Experimentation in Clinical Trials: Design and Analysis. Springer New York, 2015.

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The design and analysis of sequential clinical trials. 2nd ed. Ellis Horwood, 1992.

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Book chapters on the topic "Trial Sequential Analysis"

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Hall, W. Jackson. "Analysis of Sequential Clinical Trials." In Modern Clinical Trial Analysis. Springer New York, 2012. http://dx.doi.org/10.1007/978-1-4614-4322-3_4.

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Wang, Sidi, Thomas Braun, Roy Tamura, and Kelley M. Kidwell. "Small Sample, Sequential, Multiple Assignment, Randomized Trial Design and Analysis." In Handbook of Statistical Methods for Precision Medicine. Chapman and Hall/CRC, 2024. http://dx.doi.org/10.1201/9781003216223-2.

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Shih, Weichung Joe, and Joseph Aisner. "Sequential Designs and Methods—Part III: Classical Group Sequential Trials." In Statistical Design, Monitoring, and Analysis of Clinical Trials, 2nd ed. Chapman and Hall/CRC, 2021. http://dx.doi.org/10.1201/9781003176527-9.

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Shih, Weichung Joe, and Joseph Aisner. "Sequential Designs and Methods—Part II: Monitoring Safety and Futility." In Statistical Design, Monitoring, and Analysis of Clinical Trials, 2nd ed. Chapman and Hall/CRC, 2021. http://dx.doi.org/10.1201/9781003176527-8.

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Siegmund, David. "A Retrospective of Wald’s Sequential Analysis—Its Relation to Change-point Detection and Sequential Clinical Trials." In Statistical Decision Theory and Related Topics V. Springer New York, 1994. http://dx.doi.org/10.1007/978-1-4612-2618-5_2.

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Shih, Weichung Joe, and Joseph Aisner. "Sequential Designs and Methods—Part I: Expected Sample Size and Two-Stage Phase II Trials in Oncology." In Statistical Design, Monitoring, and Analysis of Clinical Trials, 2nd ed. Chapman and Hall/CRC, 2021. http://dx.doi.org/10.1201/9781003176527-7.

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Schmidtke, J., and B. Schneider. "TRIQ — A PC-Program for Design and Analysis of Triangular Sequential Trials." In Compstat. Physica-Verlag HD, 1994. http://dx.doi.org/10.1007/978-3-642-52463-9_22.

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"Interim Analysis of the Helsinki Heart Study Primary Prevention Trial." In Biopharmaceutical Sequential Statistical Applications. CRC Press, 1992. http://dx.doi.org/10.1201/9781482277128-25.

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Qian, Wendi, and Philip J. Brown. "Bayes Sequential Decision Theory in Clinical Trials." In Bayesian Statistics 6. Oxford University PressOxford, 1999. http://dx.doi.org/10.1093/oso/9780198504856.003.0044.

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Abstract We give a Bayesian analysis of the group sequential clinical trial to compare an experimental treatment with the standard treatment. Survival time is modelled as exponential. The trial is monitored at specified time points, either after fixed time intervals or after a fixed number of failures. The group sequential trial may consequently be modelled as a straightforward sequential trial in which survival time is the sum of exponential random variables, that is it has a gamma distribution. We use Bayes sequential decision theory to analyse the trial. The feature of this which is technically demanding is the need, after each observation, to look forward to see whether or not to continue sampling or to stop and make a terminal decision. This typically requires the nested sequence of integrations and minimisations. We provide two approximations: firstly taking the logarithm ofthe gamma random variable as normal; secondly making a reduction to logrank statistics. Monte Carlo simulations show both approximations to be comparable with respect to frequentist and Bayesian characteristics and to have good robustness with respect to prior specifications.
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Li, Chen, Ping Huang, and Haitao Pan. "Introduction to Bayesian Group Sequential Design." In Clinical Trials - Recent Advances [Working Title]. IntechOpen, 2022. http://dx.doi.org/10.5772/intechopen.108852.

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In classical group sequential designs, a clinical trial is considered as a success if the experimental treatment is statistically significantly better than placebo. The criteria for stopping or continuing the trial are chosen to control the false-positive rate (type I error). Bayesian group sequential design has an advantage of allowing inclusion of prior information in the analysis. The decision criteria can be based on the posterior or predictive distribution of the treatment effect to stop for success or futility, or to continue for each interim analysis and the final analysis. This chapter introduces Bayesian group sequential designs with examples in a confirmatory setting, including how to calibrate the tuning parameters to set up decision criteria for the interim and final analyses, how to derive the sample size, and how to evaluate the operating characteristics via simulations.
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Conference papers on the topic "Trial Sequential Analysis"

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LIU, AIYI, CHENGQING WU, and KAI F. YU. "INCORPORATING OVERRUNNING DATA INTO THE ANALYSIS OF BOTH PRIMARY AND SECONDARY ENDPOINTS IN A SEQUENTIAL TRIAL." In Random Walk, Sequential Analysis and Related Topics - A Festschrift in Honor of Yuan-Shih Chow. WORLD SCIENTIFIC, 2006. http://dx.doi.org/10.1142/9789812772558_0004.

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Zhang, Shanshan, Kun Wang, Minpeng Xu, et al. "Analysis and Classification for Single-Trial EEG Induced by Sequential Finger Movements." In 2019 41st Annual International Conference of the IEEE Engineering in Medicine & Biology Society (EMBC). IEEE, 2019. http://dx.doi.org/10.1109/embc.2019.8857117.

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Lasso Andrade, Fabricio Andres. "OP003 Magnesium sulfate in neuropathic pain: a systematic review, meta-analysis, and sequential trial analysis." In ESRA Abstracts, 41st Annual ESRA Congress, 4–7th September 2024. BMJ Publishing Group Ltd, 2024. http://dx.doi.org/10.1136/rapm-2024-esra.3.

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Sun, Fengmei, Juan Zhang, and Yuepu Pu. "Glucose-6-phosphate dehydrogenase deficiency and the risk of malaria: A meta-analysis and trial sequential analysis." In 2ND INTERNATIONAL CONFERENCE ON MATERIALS SCIENCE, RESOURCE AND ENVIRONMENTAL ENGINEERING (MSREE 2017). Author(s), 2017. http://dx.doi.org/10.1063/1.5005230.

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Zayed, Y., M. Banifadel, B. N. Alzghoul, et al. "Balanced Crystalloids versus Normal Saline for the Critically Ill Patients: A Meta-Analysis and Trial Sequential Analysis." In American Thoracic Society 2022 International Conference, May 13-18, 2022 - San Francisco, CA. American Thoracic Society, 2022. http://dx.doi.org/10.1164/ajrccm-conference.2022.205.1_meetingabstracts.a3702.

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Grape, S., E. Jaunin, K. El-Boghdadly, and E. Albrecht. "ESRA19-0175 The analgesic efficacy of pecs blocks after breast surgery: a systematic review, meta-analysis and trial sequential analysis." In Abstracts of the European Society of Regional Anesthesia, September 11–14, 2019. BMJ Publishing Group Ltd, 2019. http://dx.doi.org/10.1136/rapm-2019-esraabs2019.85.

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Iltaf Satti, Danish, Yan Hiu Athena Lee, Keith Sai Kit Leung, et al. "100 Efficacy of vasopressin, steroid, and epinephrine protocol for in-hospital cardiac arrest resuscitation: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis." In British Cardiovascular Society Annual Conference, ‘100 years of Cardiology’, 6–8 June 2022. BMJ Publishing Group Ltd and British Cardiovascular Society, 2022. http://dx.doi.org/10.1136/heartjnl-2022-bcs.100.

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McConechy, Melissa K., Suzan McNamara, Mathilde Couetoux du Tertre, et al. "Abstract A07: Sequential ctDNA analysis detected preclinical relapse in patients with metastatic colorectal cancer from the Exactis trial (NCT00984048)." In Abstracts: AACR Special Conference on Advances in Liquid Biopsies; January 13-16, 2020; Miami, FL. American Association for Cancer Research, 2020. http://dx.doi.org/10.1158/1557-3265.liqbiop20-a07.

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Gonvers, E., K. El-Boghdadly, S. Grape, and E. Albrecht. "39 Efficacy and safety of intrathecal morphine for analgesia after lower joint arthroplasty: a systematic review and meta-analysis with meta-regression and trial sequential analysis." In ESRA 2021 Virtual Congress, 8–9–10 September 2021. BMJ Publishing Group Ltd, 2021. http://dx.doi.org/10.1136/rapm-2021-esra.39.

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Balnave, K., A. J. Moriarty, and S. D. Nelson. "EVALUATION OF OPTIMUM STREPTOKINASE DOSAGE IN SYSTEMIC THROMBOLYTIC THERAPY FOR ACUTE MYOCARDIAL INFARCTION: A RANDOMIZED TRIAL." In XIth International Congress on Thrombosis and Haemostasis. Schattauer GmbH, 1987. http://dx.doi.org/10.1055/s-0038-1642992.

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The aim of this ongoing study is to determine whether or not there is a difference in terms of efficacy between lower dose and higher dose streptokinase (STK) regimens used in the systemic thrombolytic therapy of acute myocardial infarction. Acute infarction patients are randomized to low dose (600,000 I.U.) or high dose (1,500,000 I.U.) STK delivered over 30 minutes. To date 52 cases have been serially paired and analysed statistically by the method of sequential analysis. One response taken to be of primary importance as an indirect indicator of clot lysis in assessment of treatment is the time to onset of recession of the ST segment towards the isoelectric baseline on the ECG.Another response is the ratio of fibrinogen/fibrin degradation products formed per unit of plasma fibrinogen. This is a direct measurement of plasmin activity. Treatment preference per low dose/high dose pairing is plotted in Figures 1 and 2 respectively for each response. No chart entry is made where there is no marked preference. In both instances, though statistical significance (p &lt; 0.05) has not yet been reached, the trend is strongly in favour of low dose STK or, at a minimum, no difference between the doses. Not least, this has economic implications also.
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Reports on the topic "Trial Sequential Analysis"

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tian, hao. Acupuncture treatment for COPD: a trial sequential meta‑analysis. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, 2021. http://dx.doi.org/10.37766/inplasy2021.12.0007.

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Li, Jia-Qi, PWH Kwong, YW Sun, WS So, and A. Sidarta. A comprehensive appraisal of meta-analyses in exercise-based stroke rehabilitation with trial sequential analysis. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, 2022. http://dx.doi.org/10.37766/inplasy2022.8.0006.

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Review question / Objective: This study aims to use the trial sequential analysis (TSA) method to examine if the published meta-analyses concerning stroke rehabilitation reached the required information size and if the overall effect size is robust as well. Condition being studied: Stroke rehabilitation. Eligibility criteria: Studies were included if they 1) were meta-analyses of random control trials (RCTs) on people with stroke, 2) included meta-analyses results in gait speed (or 6MWT) or bal-ance performance. Studies were excluded if they 1) were conference abstracts, letters to the editor 2) lack the statistical parameters such as mean, standard deviations (SD), and number value in the articles and raw data from the cited studies cannot be found.
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Zhang, Yang, Qiong Xu, Feng Zhang, and Chunlei Sun. Probiotics for Preventing Neonatal Necrotizing Enterocolitis: A Meta-analysis with Trial Sequential Analysis. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, 2023. http://dx.doi.org/10.37766/inplasy2023.3.0124.

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Jhuang, Bo-Jyun, Bo-Han Yeh, Yen-Ta Haung, and Pei-Chun Lai. Efficacy and safety of remimazolam for procedure sedation: A meta-analysis of randomized controlled trials with trial sequential analysis. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, 2020. http://dx.doi.org/10.37766/inplasy2020.8.0043.

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LI, Peng, Junhong Ren, and Yan Li. Lung ultrasound guided therapy for heart failure: an updated meta-analyses and trial sequential analysis. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, 2022. http://dx.doi.org/10.37766/inplasy2022.2.0124.

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Review question / Objective: We aim to evaluate the effect of lung ultrasound (LU) guided therapy on the rates of adverse cardiac events (MACE) in heart failure (HF) patients. Condition being studied: Previous studies have found that B-lines assessed by lung ultrasound can be used for risk stratification in patients with HF and to predict the occurrence of adverse cardiac events. Therefore, similar to BNP, lung ultrasound has clinical value in guiding the management of patients with HF. However, the role of LU in guiding HF therapy is still controversial. Moreover, previous study's samples are too small to explain the over clinical outcomes. Besides, previous meta-analyses study did not perform meta-regression and/or subgroup analyses, or further analyze other parameters, such as heart function, quality of life and length of hospital stay.
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Li, Jia, Jiao Huang, and Jingchen Liu. Perioperative intravenous lidocaine for postoperative pain after breast surgery: A meta-analysis with trial sequential analysis of randomized controlled trials. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, 2022. http://dx.doi.org/10.37766/inplasy2022.10.0033.

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Gu, Si-Chun, Li-Min Zhang, Chun-Xu Wang, et al. Chinese herbal medicines for mild cognitive impairment: A protocol for meta-analysis and trial sequential analysis. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, 2021. http://dx.doi.org/10.37766/inplasy2021.9.0006.

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Qiu, Zhongming, and Chang Liu. Mechanical thrombectomy for large-core ischemic stroke: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, 2023. http://dx.doi.org/10.37766/inplasy2023.10.0076.

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Xiao, Chuan, Feng Shen, Yumei Cheng, and Jingjing Xiao. Timing of initiation of renal replacement therapy for acute kidney injury: a meta-analysis with trial sequential analysis of randomized controlled trials. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, 2020. http://dx.doi.org/10.37766/inplasy2020.12.0030.

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Kwong, PWH, Ho Ching Ng, Tsz Wan Leung, Man Hei Wong, and Jia-Qi Li. A comprehensive appraisal of meta-analyses in exercise-based upper limb stroke rehabilitation with trial sequential analysis. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, 2025. https://doi.org/10.37766/inplasy2025.4.0019.

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