| Recruitment of subjects refers to the process of publicly recruiting information to enable potential subjects to receive and participate in the screening of clinical trials.It is one of the key links that affect the feasibility and quality of trials.The recruitment of subjects in clinical trials is often affected by the type of disease,intervention measures,outcome indicators,test site,etc.,and each has its own characteristics.Many trials cannot be carried out according to the original time schedule,and often need to extend the recruitment period,increase the number of recruitment centers or increase Only additional capital investment can achieve the target sample size for recruitment.The recruitment of subjects in randomized controlled trials of traditional Chinese medicine requires comprehensive consideration of the multiple characteristics of traditional Chinese medicine,disease types,and trial design types.There is currently no methodological system for formulating targeted recruitment strategies for subjects.The purpose of this study is to explore and formulate a strategy for recruiting subjects for randomized controlled trials of traditional Chinese medicine,so as to provide a reference for future recruitment of subjects.Objectives1)Systematically sort out the domestic and foreign published literatures on clinical trial subject recruitment work and strategy research,summarize and summarize the subject recruitment strategies and methodological suggestions under different clinical research characteristics.2)Learn from implementation research The idea and method of this study is to use a national multi-center,randomized,placebo-controlled clinical trial of adjuvant chemotherapy of colon cancer with traditional Chinese medicine as a pilot study to implement the formulated recruitment strategy.Identify and resolve difficulties in the recruitment process.Combining the characteristics of clinical trials of traditional Chinese medicine,methodological suggestions for the formulation of recruitment strategies for clinical trials of traditional Chinese medicine are proposed.MethodsSystem searched domestic and foreign databases such as CNKI,Wanfang Data,VIP,China Biomedical Literature Database(CBM)and PubMed.Regarding clinical trial recruitment work reports or clinical trial-based methodological studies,literature feature analysis was performed,the types and frequency of clinical trial recruitment channels reported in the literature were statistically classified,summarized,and methodological suggestions were made.The research ethics review was approved.Based on a clinical trial of colon cancer Chinese medicine-assisted chemotherapy as a pilot study,drawing on the ideas of the implementation research method,on the basis of previous literature research,using the nominal group method,the formation of researchers,clinicians,target patients,ethicists,methodology Panels of multi-stakeholders such as experts,legal experts,advertising media people,etc.,referring to the clinical trial research plan and the characteristics of the subjects,discuss the advantages and limitations of various existing recruitment channels or strategies,and the implementation process Feasibility and specific implementation details.The investigator determines the recruitment channels that can be used according to the actual situation of the clinical trial and formulates the subject recruitment plan;based on the researcher team manpower,recruitment costs and access to resources of the recruitment channel,the recruitment work is initiated;the recruitment responsible personnel are identified and trained,Observe and record the implementation process and results,clarify which recruitment channels are effective,explore the reasons that affect the recruitment implementation effect and analyze it;according to the different recruitment channel implementation environment,regular feedback and correction.Conduct interviews with the research members of this clinical trial,and strive to gain a deeper understanding of the reasons that affect the recruitment effect of the subjects,and supplement the previous analysis of the reasons for the recruitment effect.Results1.Literature research on the recruitment methods of existing clinical trial subjectsA total of 27 literatures were included,including 1 Chinese literature and 26 English literature.There were 16 methodological studies comparing the effects of various recruitment channels,including 5 comparisons of recruitment cost and research methodological literature,and 8 reports.In view of recruitment experience,2 articles put forward suggestions for formulating recruitment strategies,and 1 article studies whether different recruitment channels affect the experimental effect.The 27 articles were published from 2006 to 2019,with the largest number of articles in 2013(4/27).In terms of publishing countries,the United States has published the most relevant research(18/27).The impact factor averaged 2.55 points and the highest was 18.639.There are various types of diseases in clinical trials,including diabetes,Parkinson's disease,cancer,cardiovascular and cerebrovascular diseases,and other chronic diseases.No clinical trial recruitment reports have been found for acute diseases.17 documents indicate that the experiment is funded by funds.From the perspective of clinical trial recruitment channels,17 articles mentioned the promotion of recruitment information through traditional media and post/letter;11 articles mentioned the promotion of recruitment of subjects through the distribution of trial brochures;8 articles mentioned the adoption of medical care The staff recommended suitable patients to participate in the trial,or recruited through the website link;5 articles mentioned recruiting suitable patients through screening database or medical institution case database.In addition,a small amount of literature mentions using Facebook and other social platforms,holding health lectures,and posting recruitment advertisements on public transportation or public places.Based on the comprehensive recruitment channels and implementation process,there are roughly three types of recruitment strategies.The first category is an information-based recruitment strategy(25 articles),which regularly publishes recruitment information with a certain frequency through traditional media,social media,and website platforms.The second category is a clinical-based recruitment strategy(12 articles).Through medical staff recommendation,the medical records of research institutions and hospital case libraries are screened to select eligible patients.The third category is a recruitment strategy based on peer collaboration(10 articles).It seeks cooperation with relevant societies,enterprises,medical institutions,and universities,and publishes recruitment information for joint development.2.An implementation study of subject recruitment based on a randomized controlled trial of tumor-assisted chemotherapy2.1 Development of the subject recruitment plan for joint decision-making between doctors and patients15 recruitment channels were collected from the literature,including doctor recommendation,posting recruitment information in the hospital,posting recruitment information on the hospital's official website,screening from the hospital case database,posting recruitment information on professional recruitment websites,and related websites(such as good doctors)Online)Recruitment information,recruitment within the patient group(such as WeChat,QQ group,etc.),distribution of patient recruitment information to the patient,TV broadcast recruitment information,radio broadcast recruitment information,recruitment by well-known experts on TV for health promotion Propaganda,newspaper advertisements for recruitment of subjects,community advertisements for recruitment of subjects,recruitment of community clinics,and recruitment of emails.The team members added three additional recruitment channels,namely patient organizations,large academic conferences,and medical representatives.Through the joint decision of the team members,12 recruitment channels were finally determined,which were doctor recommendation,posting recruitment information in the hospital,posting recruitment information on the hospital's official website,posting recruitment information on the professional recruitment website,and patient groups(such as WeChat group,QQ group Etc.)Recruitment,distribution of recruitment information pages for patients,community recruitment advertisements for recruitment of subjects,recruitment of community clinics,large academic conferences,large patient organizations,screening from the hospital case database,introduction of medical representatives.For the inclusion of this tumor clinical trial,it is necessary to include patients who have not undergone chemotherapy for six weeks after radical resection.It is considered that the recruitment start time is "one month before the start of the trial and three months before the end of the trial".The implementation of the recruitment method requires the recruitment of assistants.If the patient wants to know more detailed information,come to the inquiry or telephone consultation,and have someone to answer it,which will help to increase the understanding and trust of potential subjects in the trial.2.2 Subject recruitment and process analysis based on a multi-center clinical trial of colon cancer Chinese medicine adjuvant chemotherapyOn November 7,2018,the recruitment information of clinical trial subjects was published on the official website of a hospital(the clinical trial research unit,the top three Chinese medicine hospitals).As of March 10,2020,the number of views reached 6,047;Roll-up banners with recruitment information are placed with small cards printed with recruitment information at the clinic;on November 14,2018,they contacted the professional recruitment website and failed to obtain cooperation.It said that for tumor diseases,its platform mainly accepts clinical trials of immune and targeted therapy interventions.In terms of traditional Chinese medicine,the patient reserve is limited,and it is inconsistent with the current recruitment direction of its platform;November 30,2018.To the QQ tumor patient group(2,the group number is 2793,1900 respectively,the group members basically cover various types of tumors),WeChat tumor patient group(4,the group number is 429,353,359,94 People,group members basically cover all kinds of tumors),the subject recruitment information is released,the group owner and group members have a negative attitude towards Chinese medicine,and it is forbidden for anyone other than the group owner to release any information;The person in charge of the website said that there is no recruitment channel for subjects on the website,and doctors are required to publish recruitment information through the personal account of the website.Due to the limited conditions of this study,this recruitment channel has not continued;March 13,2019 The platform publishes recruitment information for subjects,and the number of views is 713;on April 3,2019,the recruitment advertisement was published through the offline anti-cancer rehabilitation publicity lecture channel,but the required By the presence of disease,"time window",to listen to many old patients and their families,recruitment propaganda ineffective;September 2019 to November,a total of 246 patients screened.Among them,23 patients were qualified through hospital recruitment,and finally 9 were enrolled;through media recruitment(posting a round of recruitment information every month),the total number of patients consulted by phone calls reached 223,and the number of patients consulted each month was 118,47,58 people,4,6 and 10 qualified patients are obtained every month,and 0,0 and 1 are finally enrolled.Within 1-3 days after the recruitment information was released through the media,patients had the largest number of inquiries.From the perspective of obtaining qualified patients,the media recruitment of patients is more effective.From the perspective of enrollment,in-hospital departments and/or doctors recommend recruiting in hospitals,and more enrolled patients.After interviewing some research members,it was found that the source of the patients recruited by the principal research unit(Chinese medicine hospital)was partly operated on in surgery,partly in outpatient clinics,and partly the patients in foreign hospitals actively sought TCM treatment.Compared with other western hospital sub-centers,there are significantly fewer patients of surgical origin.Postoperative chemotherapy is a fixed and standardized program.Whether the patient is undergoing chemotherapy in the Chinese medicine hospital or the Western hospital is different.ConclusionsAccording to the literature,the most common recruitment channels include doctors and nurses recommending them,newspaper and radio broadcasts,distribution of recruitment brochures,and email recruitment.There are few studies on patient recruitment in China,which indicates to a certain extent that the recruitment of subjects is not valued.The research report on the recruitment of some subjects is not comprehensive enough to judge the recruitment channel or strategy effect.The difficulty of recruiting in the clinical trials relying on this study mainly lies in the strict eligibility criteria and the "time window" of the disease of the target patients.At present,the recruitment effect in the hospital is better,and the media recruitment effect needs to be strengthened.Mainly reflected in the media recruitment effect,on the one hand,it is greatly affected by the characteristics of potential subjects,including its ability to understand recruitment information,and cognitive bias in participating in clinical trials.On the other hand,its effect is affected by the frequency of media distribution.Due to the influence of the social environment at home and abroad,some recruitment methods are not necessarily applicable in China.In addition to the medical environment,patient organizations such as WeChat group and QQ group of patients are gathered.Through such recruitment channels,the recruitment information of the subjects can be diffused in a short time and in large numbers.However,in the group of patient groups,it is not easy to obtain patient trust.Intersessional meetings have a high degree of trust,and it is more effective for patients to directly recommend trial recruitment information.The recruitment cost of professional recruitment websites is relatively high,the conditions of this study are limited,and it cannot be implemented,and the effectiveness evaluation is conducted.Recruitment work should be carried out based on the actual situation.According to different clinical research purposes and characteristics of research objects,different recruitment methods have their own advantages and disadvantages.Appropriate recruitment strategies should be developed in accordance with the characteristics of the trial,and recruitment channels should be enriched.Patients and other aspects explore the factors that affect the recruitment of subjects,analyze and solve the obstacles to recruitment implementation,and improve the research on the recruitment strategy of subjects,with a view to improving recruitment efficiency in the future. |
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