Establishing a core outcome set for neurogenic bladder trials: study protocol for a scoping review and Delphi surveys

Zhang, Yan; Chen, Yamin; Niu, Mingming; Li, Yuanyuan; Zhang, Jiaoyan; Zhang, Li; Wu, Fangfang; Chen, Qing‐Yun; Yu, Hui‐Jin; Tian, Jin Hui

doi:10.1186/s13063-022-06419-1

Cited by 4 publications

(3 citation statements)

References 31 publications

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“…However, there is a pronounced heterogeneity and low comparability between studies. This makes it di cult to compare and pool results, and therefore restricts the application and promotion of perioperative exercise and hinders the synthesis of evidence [31]. How effective these exercise interventions are can only be truly understood if clinical trials report the same outcomes, which are measured and de ned in the same way.…”

Section: Discussionmentioning

confidence: 99%

Study protocol: a core outcome set for perioperative exercise clinical effectiveness trials for lung cancer patients

Zhou,

Zhang,

Wang

et al. 2023

Preprint

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Background Outcome assessment in perioperative exercise trials of lung cancer is heterogeneous, often omitting those that are important and patient-relevant. This hinders evidence synthesis. To solve this problem, a core outcome set, an agreed standardized set of outcomes to be measured and reported to reduce heterogeneity among outcome measures, is needed. This study protocol describes the methodology, aiming to develop a core outcome set for perioperative exercise intervention trials for lung cancer in clinical practice. Methods The project will follow the standard methodology recommended by the Core Outcome Measures in Effectiveness Trials (COMET) initiative, Which will be divided into four steps. Stage Ⅰ: Conduct a scoping review of outcomes reported in clinical trials and protocols to develop a list of potential outcome domains.. Stage Ⅱ: Conduct semi-structured interviews to obtain important outcomes for patients. Stage Ⅲ: Choose the most important outcomes by conducting two-round Delphi surveys. Stage Ⅳ: Establish consensus in a face-to-face meeting to discuss the final core outcome set. Discussion This is the first project identified for the core outcome set of outcomes for perioperative exercise trials for lung cancer, which will improve the quality, comparability, and usability of future trials and positively impact the perioperative exercise and the care of patients with lung cancer. Trials registration Core Outcome Measurement in effectiveness Trials (COMET) Initiative database registration: https://www.comet-initiative.org/Studies/Details/2091

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Section: Discussionmentioning

confidence: 99%

Study protocol: a core outcome set for perioperative exercise clinical effectiveness trials for lung cancer patients

Zhou,

Zhang,

Wang

et al. 2023

Preprint

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“…Disagreement will be resolved through discussion with a third reviewer. Results will include all unique outcomes and a frequency table of the most reported outcomes, sorted per outcome domain [ 22 ]. This list of unique outcomes will be presented to the expert panel (phase 2).…”

Section: Methodsmentioning

confidence: 99%

“…There is no consensus on the optimal sample size for the Delphi study, and based on the content of published literature, sample sizes for health professionals typically range from 30 to 120 participants [ 22 , 25 , 26 ]. In this study, following the research purpose of the project, we adhered to the principles of authority, representativeness, and regionality.…”

Section: Methodsmentioning

confidence: 99%

Developing a Core Outcome Set for Assessing Clinical Safety Outcomes of Prostate Cancer in Clinical Trials of Traditional Chinese Medicine: Protocol for a Mixed Methods Study

Tian,

Zhang,

Ren

et al. 2023

JMIR Res Protoc

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Background Among the common malignant tumors in men worldwide, the incidence of prostate cancer ranks second to lung cancer. This disease will bring an economic burden to patients and their families and can reduce the quality of life of patients. Researchers have conducted numerous clinical trials on the efficacy and safety of different interventions in the treatment of prostate cancer with traditional Chinese medicine (TCM) combined with standard treatment regimens. However, the currently published clinical trials exhibit inconsistent and irregular reporting of outcome measures. Objective The objective of this paper is to emphasize the need for a core outcome set (COS) to facilitate future prostate cancer research, aiming to improve the quality of trials and generate high-quality evidence. Methods This mixed methods project has three phases, as follows: (1) a scoping review of the literature to identify outcomes that have been reported in clinical trials and systematic reviews of interventions involving TCM for the treatment of prostate cancer as well as a qualitative component using interviews to obtain the views of patients with prostate cancer, their families, and their caregivers who have a history of TCM treatment; (2) a Delphi survey among stakeholders to prioritize the core outcomes—Participants will include traditional Chinese and Western medicine clinicians in prostate cancer–related directions, nurses, and methodology experts who will participate in 2 rounds of the Delphi method expert consultation to score each outcome in the list of outcome indicators; and (3) a face-to-face consensus meeting to discuss and agree on the final COS for the application of TCM in the treatment of prostate cancer. Results The protocol has been registered in PROSPERO (CRD42022356184) before the start of the review process, and we will initiate the review on August 1, 2023; results should be expected by September 1, 2023. The Delphi survey among stakeholders is expected to start in October 2023. Conclusions The development of a core outcome set for assessing clinical safety outcomes of prostate cancer in clinical trials of TCM will provide a significant first step to assist Chinese doctors, researchers, and policy makers. Trial Registration PROSPERO CRD42022356184; https://tinyurl.com/ysakz74r International Registered Report Identifier (IRRID) PRR1-10.2196/46794

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Study protocol: a core outcome set for perioperative exercise clinical effectiveness trials for lung cancer patients

Zhou,

Zhang,

Wang

et al. 2024

Trials

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Background Outcome assessment in perioperative exercise trials for lung cancer is heterogeneous, often omitting those that are important and patient-relevant. This heterogeneity hinders the synthesis of evidence. To address this issue, a core outcome set, an agreed-upon standardized set of outcomes to be measured and reported, is required to reduce heterogeneity among outcome measurements. This study protocol describes the methodology, aiming to develop a core outcome set for perioperative exercise intervention trials for lung cancer in clinical practice. Methods The project will follow the standard methodology recommended by the Core Outcome Measures in Effectiveness Trials (COMET) initiative, which is divided into four steps. Stage I: Conducting a scoping review of outcomes reported in clinical trials and protocols to develop a list of potential outcome domains. Stage II: Conducting semi-structured interviews to obtain important outcomes for patients. Stage III: Choosing the most important outcomes by conducting two rounds of the Delphi exercise. Stage IV: Achieving a consensus in a face-to-face meeting to discuss the final core outcome set. Discussion This is the first project identified for the core outcome set of perioperative exercise trials in lung cancer, which will enhance the quality, comparability, and usability of future trials and positively impact perioperative exercise and the care of patients with lung cancer. Trials registration Core Outcome Measurement in Effectiveness Trials (COMET) Initiative database registration: https://www.comet-initiative.org/Studies/Details/2091

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Establishing a core outcome set for neurogenic bladder trials: study protocol for a scoping review and Delphi surveys

Cited by 4 publications

References 31 publications

Study protocol: a core outcome set for perioperative exercise clinical effectiveness trials for lung cancer patients

Study protocol: a core outcome set for perioperative exercise clinical effectiveness trials for lung cancer patients

Developing a Core Outcome Set for Assessing Clinical Safety Outcomes of Prostate Cancer in Clinical Trials of Traditional Chinese Medicine: Protocol for a Mixed Methods Study

Study protocol: a core outcome set for perioperative exercise clinical effectiveness trials for lung cancer patients

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