| Background and ObjectiveThe compliance of patients in clinical trials is mainly manifested some aspects,which involves the patients who were included in the trial were randomly divided into groups whether they accepted the complete intervention measures,and whether they remained intact in the course of treatment and follow-up.Previous studies have shown that under the right intervention measures,the poor compliance of patients will affect the results of trials,and will lead to the lack of effective data,which will lead to bias in the trials results.Through searching published clinical randomized controlled study of acupuncture,the study summarize the preliminary report of missing data in Chinese acupuncture clinical trials for the last ten years,and to explore the influence of missing data on study conclusion through the secondary analyses.To assess the impact of loss data on the results of clinical trials,and to provide evidence-based medical evidence.And the study was to explore the influence factors on patients participating in or completing the acupuncture trials through cross-sectional survey and qualitative interview.Then proposed the potential methods on improving patient compliance.MethodsStudy one:Based on the searching results of China Network Knowledge Infrastructure databases,we included randomized controlled trials(RCTs)testing acupuncture,which published from January 2006 to December 2015.Trough selecting eligible studies and data extraction,we analyzed the reporting rate of missing data and the trends of reporting.Meanwhile,we analyzed the reasons leading to missing data and the condition using intention to treat(ITT)analysis to deal with missing data.For studies with two-arm reporting categorical variables,we analyzed missing data with ITT analyses method.Results of the ITT analysis were then compared to the original results and investigated the consistency of the statistical significance.Study two:A survey was conducted at the department of acupuncture and metabolic diseases in two integrative medicine hospitals in Beijing during April,2016 and July.Patients were consecutively sampled to fill semi-structured questionnaires regardless their types of disease The questionnaire was designed based on literature review and Delphi methods.The data were provided by respondents and filled by investigators,then submitted to administrator for data analysis.Descriptive statistics was made on demographic characteristics of the patients and potential factors affecting patients 'participation or completion.SPSS22.0 software was used,and logistic regression analysis(LRA)was used to explore factors influencing patients 'decision,and multivariate LRAwas used to explore relationship between demographic characteristics and the potential influence factors.Study three:A qualitative interview was conducted at the department of acupuncture and metabolic diseases in two integrative medicine hospitals in Beijing.Through convenient sampling method,we recruited interviewees with different demographic characteristics.And the study met the principle of information saturation.Eventually,the interview involved 10 patients.According to the results of cross-sectional study about the influencing factors of patients' compliance in acupuncture clinical trials,we made the interview outline.Before the interview,the researchers were conducted systematic qualitative interview training,and patients signed informed consent.In the interview,the researchers should made flexible changes to the question of the qualitative interview,so that the interviewees could better understand the questions.One interview time was about 20 to 30 minutes.The interview was recorded by the recording pen,and the note was made well.We analyzed the subject text transcription of recording materials.In order to make a deeper understanding of the factors that affect patients' participation in or completion of the compliance of acupuncture clinical trials,and to propose a possible way to improve the compliance of acupuncture clinical trials.ResultsStudy one:We identified 3008 RCTs on acupuncture,and a total of 1184 trials(39.4%)reported missing data.The reporting rate of missing data declined during 2007,while the rate showed increasing trends which overall growth of 66.5%during the past 10 years.There were 343(11.4%)studies reported the reasons,including noncompliance,used other interventions,adverse event and so on.For 1184 trials reporting the condition of missing data,321 trials(27.1%)reported no missing data,and 863 trials reported missing data,in which the degree of missing rate of?20%,10?20%and<10%were 28(2.4%)?209(17.6%)and 626(52.9%)trials,respectively.For the 3008 trials,a total of 63(2.1%)trials mentioned ITT analysis,in which 30(1.0%)trials introduced the detail method and results of ITT analysis.358 trials with two-arm and reporting binary variables were analyzed.The ITT results showed that 108 trials(30.2%)were inconsistent with their original results,in which 92(85.2%)trials might have false positive results,and 16(14.8%)trials might have false negative results.Study two:500 patients with age of 15?85 years old were completed without dropping out.Among them,460 patients had no experience in participating clinical trials and 40 patients had participated in clinical trials before.There was no statistical difference between demographic characteristics(P>0.05).268(53.6%)participants had experience of acupuncture treatment,meanwhile 321(64.2%)of the participants had heard concept of clinical trial,who considered the benefits of clinical trials were got better effect and free treatment,et al.These two different groups of people were preferred to participate in clinical trials.When investigating patients' attitude towards enrolling in a trial,the therapeutic effect and the safety of the intervention were thought(by 92%and 96%respondents respectively)as important deciding factors.The LRA showed that the patients who had ever participated in the clinical trials paid more attention to treatment regimen(frequency and session of treatment)when deciding whether joining in trials(OR 1.54,95%CI 1.02 to 2.34).Multivariate LRA showed that elder people took cost(OR 1.36,95%CI 1.09 to 1.70)as a more important factor;the participants used medical insurance(OR 1.45,95%CI-0.20 to 0.93)preferred to think informal consent was important;meanwhile,participants with higher education level preferred to regular follow-up(OR 1.16,95%CI 0.02 to 0.28),as well as those who had medical insurance(OR 2.07,95%CI 0.19 to 1.26)or paid by public expense(OR 3.89,95%CI 0.34 to 2.37).Study three:We found that the majority of patients knew about clinical trials of acupuncture through the hospital posters.The majority of patients in acupuncture clinical trials did not know much about clinical trials,so there were some doubts about the patients,such as medical arrangements(time and frequency),treatment distance,treatment process and the convenience of the hospital registration and the qualifications of doctors,when they were in the initial contact with clinical trials.The department carried out clinical trials should do the coordination work with patients as much as possible,and try to persuade patients to do with treatment.Before treatment,the researchers should introduce the hospital and the doctor's qualifications in detail,as far as possible to eliminate the doubts of the objective factors of patients.Patients who participated in clinical trials of acupuncture were more interested in the rationality of the treatment plan,the level of doctors' treatment,efficacy,medical treatment level,hospital humanistic environment,et al.In the process of participation,there will be some difficult,such as the distance to see the doctor,the time of the visit was not easy to control,the psychological difficulty of the fear of acupuncture.At the same time,there were many benefits from acupuncture in clinical trials,such as expanding the treatment of disease,helping patients diagnose disease,a preliminary understanding of the experience of acupuncture and good curative effect etc.By participating in clinical trials of acupuncture,many patients have different opinions on the promotion of acupuncture clinical trials;there were some inconveniences such as insufficient time contradiction,far away from hospitals.But the patients for the promotion of clinical trials of acupuncture emphasized related advantages,such as:fewer side effects,obvious curative effect,helpful to conditioning the body,conducive to scientific research,promoting other measures.Some suggestions for future clinical trials of acupuncture were put forward,and the importance of medical and patient communication to treatment is also emphasized.ConclusionThrough systematic retrieval of previously published clinical randomized controlled study of acupuncture,we found the acupuncture trials in China need to pay more attention to the missing data reporting as it may influence the results.The results of secondary analyses showed that missing data may result in false-negative or false-positive error without using a reasonable method.Through cross-sectional study,we found the effect,safety of the intervention and treatment regimen of a trial would be important factors for patients on deciding whether to join in or complete acupuncture studies.The patient's acupuncture treatment experience and the understanding of clinical trials are likely to affect the patient's decision and other factors,such as cost,consent or therapeutic feedback,should be given special consideration according to specific demographic characteristics.The qualitative study found that patients who participated in acupuncture clinical trials paid attention to medical journal.The qualifications of hospital and doctors,arrangement of time,safety and economic costs and researcher's attitude.In the future,the design of acupuncture studies should improve doctor-patient communication,the treatment plan,follow-up and feedback.And we should carry out clinical trials of acupuncture as much as possible,increase the introduction of acupuncture in publicity process,increase patients' understanding of acupuncture and treatment diseases,and provide design ideas for improving patient compliance in clinical trials. |
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