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Advances in Clinical Trials and Evidence Synthesis (CTES)
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Advances in Clinical Trials and Evidence Synthesis (CTES)

A special issue of Journal of Clinical Medicine (ISSN 2077-0383). This special issue belongs to the section "Epidemiology & Public Health".

Deadline for manuscript submissions: closed (10 July 2023) | Viewed by 6750

Special Issue Editors

Dr. Feng Sun

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Guest Editor
Department of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Centre, Beijing, China
Interests: evidence-based medicine; pharmacoepidemiology; clinical epidemiology
Dr. Shusen Sun

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Guest Editor
Department of Pharmacy Practice, College of Pharmacy and Health Sciences, Western New England University, Springfield, MA 01119, USA
Interests: environmental toxicology; emergency care; medication safety; global pharmacy education and training; evidenced-based medicine; pharmacovigilance
Special Issues, Collections and Topics in MDPI journals
Dr. Shanshan Wu

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Guest Editor
Department of Gastroenterology, National Clinical Research Center for Digestive Diseases, Beijing Friendship Hospital, Capital Medical University, Beijing, China
Interests: evidence synthesis; network meta-analysis; prediction model; gastroenterology
Dr. Zhirong Yang

E-Mail Website
Guest Editor
1. Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences, Shenzhen, China
2. Primary Care Unit, Department of Public Health and Primary Care, School of Clinical Medicine, University of Cambridge, Cambridge, UK
Interests: pharmacoepidemiology; pharmacy administration; clinical epidemiology; evidence synthesis; meta-analysis; real-word study; routine health care data; clinical research methodology; public health; intelligent healthcare; vaccines; dementia; diabetes; cardiovascular disease

Special Issue Information

Dear Colleagues,

Clinical and epidemiological research provides an evidence foundation for healthcare decision making. The quality of evidence largely relies on whether the methodology in research is rigorous. While recent years have seen remarkable progress in clinical research methodology, problems remain common in study design, in conducting and reporting clinical trials, real-world studies, and evidence synthesis, which may bias study results and mislead decision making. It is important to develop novel methods to address the methodological problems. In this Special Issue, we would like to create a forum for high-quality research and review papers on methodology to improve the quality of clinical trials, real-world studies, and evidence synthesis. We also welcome clinical or epidemiological research papers applying advanced methods in these fields. The following topics will be of special interest:

  • Methodological problems in study design, in conducting or reporting clinical trials, real-world study, and evidence synthesis;
  • Progress in methods of study design, conducting or reporting clinical trials, real-world study, and evidence synthesis;
  • Application research using advanced methods in clinical trials, real-world studies, and evidence synthesis

Dr. Feng Sun
Dr. Shusen Sun
Dr. Zhirong Yang
Dr. Shanshan Wu
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Journal of Clinical Medicine is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • methodological research
  • real-world study
  • evidence synthesis
  • clinical trial
  • epidemiology

Published Papers (2 papers)

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Research

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10 pages, 289 KiB  
Article
Methods for the Inclusion of Real-World Evidence in a Rare Events Meta-Analysis of Randomized Controlled Trials
by Minghong Yao, Yuning Wang, Fan Mei, Kang Zou, Ling Li and Xin Sun
J. Clin. Med. 2023, 12(4), 1690; https://0-doi-org.brum.beds.ac.uk/10.3390/jcm12041690 - 20 Feb 2023
Cited by 4 | Viewed by 1348
Abstract
Background: Many rare events meta-analyses of randomized controlled trials (RCTs) have lower statistical power, and real-world evidence (RWE) is becoming widely recognized as a valuable source of evidence. The purpose of this study is to investigate methods for including RWE in a rare [...] Read more.
Background: Many rare events meta-analyses of randomized controlled trials (RCTs) have lower statistical power, and real-world evidence (RWE) is becoming widely recognized as a valuable source of evidence. The purpose of this study is to investigate methods for including RWE in a rare events meta-analysis of RCTs and the impact on the level of uncertainty around the estimates. Methods: Four methods for the inclusion of RWE in evidence synthesis were investigated by applying them to two previously published rare events meta-analyses: the naïve data synthesis (NDS), the design-adjusted synthesis (DAS), the use of RWE as prior information (RPI), and the three-level hierarchical models (THMs). We gauged the effect of the inclusion of RWE by varying the degree of confidence placed in RWE. Results: This study showed that the inclusion of RWE in a rare events meta-analysis of RCTs could increase the precision of the estimates, but this depended on the method of inclusion and the level of confidence placed in RWE. NDS cannot consider the bias of RWE, and its results may be misleading. DAS resulted in stable estimates for the two examples, regardless of whether we placed high- or low-level confidence in RWE. The results of the RPI approach were sensitive to the confidence level placed in RWE. The THM was effective in allowing for accommodating differences between study types, while it had a conservative result compared with other methods. Conclusion: The inclusion of RWE in a rare events meta-analysis of RCTs could increase the level of certainty of the estimates and enhance the decision-making process. DAS might be appropriate for inclusion of RWE in a rare event meta-analysis of RCTs, but further evaluation in different scenarios of empirical or simulation studies is still warranted. Full article
(This article belongs to the Special Issue Advances in Clinical Trials and Evidence Synthesis (CTES))

Review

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20 pages, 346 KiB  
Review
Multidisciplinary Guidelines for the Rational Use of Topical Non-Steroidal Anti-Inflammatory Drugs for Musculoskeletal Pain (2022)
by Chen Shi, Zhaoming Ye, Zengwu Shao, Bifa Fan, Cibo Huang, Yuan Zhang, Xinying Kuang, Liyan Miao, Xin’an Wu, Rongsheng Zhao, Xiao Chen, Bikui Zhang, Rongsheng Tong, Xin Hu, Zhijian Fu, Jianhao Lin, Xiaomei Li, Tiezheng Sun, Guoqiang Liu, Haibin Dai, Cheng Guo, Bo Zhang, Ting Xu, Aidong Wen, Xiaocong Zuo, Jinmei Liu, Xu Chen, Huibo Li, Jing Wang, Min Luo, Tingting Fan, Yulan Qian, Xiu’mao Li, Wenjie Qiu, Xiaowen Lin, Yingchang Pang, Yunfei Hou, Difei Yao, Wen Kou, Bao Sun, Can Hu, Yanzhe Xia, Ming Zhao, Changyu Zhu, Qian Li and Yu Zhangadd Show full author list remove Hide full author list
J. Clin. Med. 2023, 12(4), 1544; https://0-doi-org.brum.beds.ac.uk/10.3390/jcm12041544 - 15 Feb 2023
Cited by 5 | Viewed by 4911
Abstract
(1) Background: Topical non-steroidal anti-inflammatory drugs (NSAIDs) are one of the primary drugs for treating musculoskeletal pain. However, there are currently no evidence-based recommendations about drug selection, drug administration, drug interactions, and use in special populations or other pharmacology-related content of such medications. [...] Read more.
(1) Background: Topical non-steroidal anti-inflammatory drugs (NSAIDs) are one of the primary drugs for treating musculoskeletal pain. However, there are currently no evidence-based recommendations about drug selection, drug administration, drug interactions, and use in special populations or other pharmacology-related content of such medications. To this end, the Chinese Pharmaceutical Association Hospital Pharmacy Professional Committee developed multidisciplinary guidelines on using topical NSAIDs to treat musculoskeletal pain. (2) Methods: The guidelines development process followed the World Health Organization guideline development handbook, the GRADE methodology, and the statement of Reporting Items for Practice Guidelines in Healthcare. The guideline panel used the Delphi method to identify six clinical questions to be addressed in the guidelines. An independent systematic review team conducted a systematic search and integration of evidence. (3) Results: Based on the balance between the benefits and harms of an intervention, the quality of the evidence, patient preferences and values, and resource utilization, the guideline panel developed 11 recommendations and nine expert consensuses on using topical NSAIDs to treat acute and chronic musculoskeletal pain. (4) Conclusions: Based on the effectiveness and overall safety of topical NSAIDs, we recommend patients with musculoskeletal pain use topical NSAIDs and suggest high-risk patients use topical NSAIDs, such as those with other diseases or receiving other concurrent treatments. The evidenced-based guidelines on topical NSAIDs for musculoskeletal pain incorporated a pharmacist perspective. The guidelines have the potential to facilitate the rational use of topical NSAIDs. The guideline panel will monitor the relevant evidence and update the recommendations accordingly. Full article
(This article belongs to the Special Issue Advances in Clinical Trials and Evidence Synthesis (CTES))
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