| BackgroundA series of articles related to "Increasing value,reducing waste" were published on Lancet in 2014,which has drawn the attention of medical researchers to the importance of research value.Since then,methodological scholar at abroad successively have carried out relevant research to explore how to avoid the waste of medical research?Therefore,it has been a considerable thesis on how to improve and enhance the value of medical research.What requires methodological and clinical medical researchers to focus on is to reconsider the whole clinical medical research system and explore the causes of waste to find out the approach and methods to improve the clinical research value.Acupuncture,as a complementary and alternative therapy,plays an important role in non-pharmaceutical therapy of traditional Chinese medicine and has been widely applied all over the world.Increasing clinical trials to evaluate the effectiveness and safety of acupuncture have been published and collected in both Chinese and English databases.Randomized controlled trials(RCTs)are known as the "gold standard" for assessing the effectiveness of interventions to provide high quality evidence in clinical practice.However,there is no study on evaluating the practical value of these trials,so we aimed to evaluate the value of acupuncture RCTs published in Chinese and English journals during recent years,and find out their possible impact to put forward suggestions to improve the value of acupuncture RCT in practice and evidence for clinical trials.Methods1.Citation and relevant factors of randomized controlled trials on acupuncture published in English literatureAcupuncture RCTs published in English journals on PubMed,EMBASE,and Cochrane Library were systematically searched.All RCTs were classified as high citations(annual citations ? 3)and low citations(annual citations<3)according to citations from the Web of Science database,which was defined as the dependent variable.The extracted influencing factors that may affect the amounts of citations of acupuncture RCTs published in English journals were defined as independent variables.Variables were selected and removed to build models based on the likelihood ratio test(LR)by stepwise logistic regression(backward method).Chi-squared automatic interaction detector(CHAID)was applied to establish a classification decision tree model,and high citations were defined as a target class.2.Evaluation of inclusion/exclusion of RCTs in the Cochrane systematic review on application valueWe systematically search the Cochrane systematic review of acupuncture RCTs in the Cochrane Library and analysis included and excluded studies in the systematic review.To evaluate the possible reason of wasting acupuncture RCTs in systematic reviews and the possible factors that influence the application value of acupuncture RCTs.3.Evaluation of inclusion/exclusion of RCTs in the evidence-based clinical practice guidelines with acupuncture on application valueWe systematically search evidence-based clinical practice guidelines with acupuncture and analysis included and excluded studies in the guidelines.To evaluate the possible reason of wasting acupuncture RCTs in guidelines and the possible factors that influence the application value of acupuncture RCTs.Results1.Citation and relevant factors of randomized controlled trials on acupuncture published in English literature796 included RCTs total citation was 21,132,the minimum was 0(32 articles),the maximum was 298,the median was 16,and the interquartile range(IQR)was 7-35.564(70.9%)RCTs were low citations(annual citations<3),and 232(29.1%)were high citation(annual citations ? 3).Univariate analysis results showed:country(western vs eastern,OR=2.95,p<0.01),coauthor(cooperative research team vs single research team,OR=1.68,p<0.01),journal type(general medical vs complementary and alternative medicine,OR=6.56,p<0.01;professional medical vs complementary and alternative medicine,OR=5.89,p<0.01),journal of impact factor(IF?3 vs IF<3,OR=7.15,p<0.01),registration(yes vs no,OR=1.80,p<0.01),number of center(multi-center vs single center,OR=2.138,p<0.01;multi-center vs unknown,OR=3.14,p<0.01),sample size(?60 vs<60,OR=1.71,p<0.01),sample size estimation(yes vs no,p<0.01,OR=2.44),number of arm(multiple vs two arms,OR=1.73,p<0.01),acupuncture type(manual vs electro-acupuneture,OR=1.42,p=0.03),Primary and secondary outcome specified(yes vs no,OR=3.14,p<0.01),random sequence generation(low vs unclear,OR=2.06,p<0.01),allocation concealment(low vs unclear,OR=2.349,P<0.01),blinding of participants and personnel(unclear vs low p<0.015 OR=0.445 p<0.01;unclear vs high p<0.01,OR=0.591);blinding of outcome assessment(unclear vs low,OR=0.46,p<0.01;unclear vs high,OR=0.59,p<0.01);incomplete outcome data(unclear vs low,OR=0.42,p<0.01;unclear vs high,OR=0.42,p<0.01),and funding(yes vs no,OR=2.54,p<0.01),which may be the impacts on application value.Five independent variables including journal impact factors,journal type,primary and secondary outcome specified,number of arms,and incomplete outcome were included in the Logistic regression model and the decision tree model,which suggests that these independent variables may be the impacts on application value of the acupuncture RCTs in English.In addition,three independent variables including countries,funding and positive results were only included in the Logistic regression model.The independent variables of blinding of participants and reseracers were only included in the decision tree model.2.Evaluation of inclusion/exclusion of RCTs in the Cochrane systematic review on application value14 Cochrane systematic reviews related to acupuncture RCTs were included,and 5(35.7%)were published before 2012,and 7(50%)systematic reviews authors were from China.The 14 systematic reviews referred to 926 articles(870 studies)during the stage of full-text screening,and finally included 167 articles(127 RCTs),accounting for 18.03%of the articles included;and meanwhile excluded 718 articles(706 RCTs),for 77.54%;and 13 waiting studies articles(11 RCTs),for 1.40%;28 ongoing articles(26 RCTs),for 3.02%.Among 127 RCTs included in the 14 systematic reviews,68 RCTs(53.54%)were considered as high risk of bias(one item is high risk bias),47 RCTs(37.1%)as unclear risk of bias,and 12 RCTs(9.45%)as low risk of bias(all item were low risk bias).Besides,11 systematic reviews(78.57%)had uncertain conclusions due to high risk of bias in the included studies.The reasons of 718 articles excluded from 14 systematic reviews:duplication(39,5.43%),obviously irrelevant(82,11.42%),participants(296,41.23%),interventions and controls(206,28.69%),outcomes(48,6.69%),inappropriate random sequence generation methods(62,8.63%),and other inappropriate methodological matters(5,0.70%),other reasons(18,2.51%)which including abstract publication,unavailable full text,language barriers,and possible plagiarism.3.Evaluation of inclusion/exclusion of RCTs in the evidence-based clinical practice guidelines with acupuncture on application value23 guidelines were included involving 19 diseases,of which 5 were issued in 20]1 and 18 were issued in 2014-2015(4 were revised edition of 2011).Among the 18 recently issued guidelines,7 guidelines included acupuncture RCTs in Chinese and English language as supporting evidence for the recommendation,10 guidelines included acupuncture RCTs in Chinese as supporting evidence for the recommendation,and one unreported reference resulting no judgement.RCTs application rate in the recommendations were calculated based on the number of RCTs included in the evaluation of the guideline and the number of RCTs used in the guideline recommendations(the number of RCTs applied in the recommendation/the number of RCTs included in the evaluation of the guideline).14 guidelines were available to be calculated with a maximum of 283%(osteoarthritis),a minimum of 5.02%(scapulohumeral periarthritis),and the rest of under 40%.The 10 guidelines reported the result of confirmation of the random authenticity in the RCTs by telephone or email contact with the authors.The results showed that the true RCTs accounted for 7.11%,the lowest was 3.64%,and the highest was 13.33%.Seven guidelines involving a total of 824 RCTs reported the reason of unacknowledged true RCTs,of which 52 RCTs(6.31%)were confirmed as true RCTs,189 RCTs(22.94%)were untrue RCTs,and 177 RCTs(21.48%)authors refused to respond,400 RCTs(48.54%)could not contact the author,4 RCTs were dialectal disorders,and 2 were duplication.According to the RCTs published in English which may meet the guidelines,apart from the unavailable RCTs data in 6 guidelines,the application rate of RCTs in English in the recommendation of remaining 12 guidelines showed the minimum of 0%(5 guidelines),100%(one guideline),and the rest all under 50%.The total application rate of RCTs in English was 26.21%.ConclusionsThe study found a low application rate of acupuncture RCTs in Cochrane systematic reviews and evidence-based clinical acupuncture practice guidelines,and the reasons may as following:inadequate reporting of participants,interventions and controls,and generation of random sequences;participants not meeting intermationally recognized standards;inappropriate comparisons;without core outcomes;inappropriate random sequence generation methods;other methodological matter,and availability of study.Possible impact on application value of acupuncture RCTs in English journals included East and West countries,author group,type of journals,impact factors of published journals,number of research centers,disease,comparison,outcome,and risk of bias.In order to improve the academic value of acupuncture RCTs,some suggestions were put forward as following.First and foremost,multi-disciplinary research teams should carry out the multi-center,large-scale sample and registrated RCTs,with internationally recognized diagnostic criteria appropriate controls,eore outcome and high quality of methodology,which indicated the high application value;secondly,acupuncture RCTs that should report in strict accordance with CONSORT statement and STRICTA for acupuncture intervention report can greatly improve the research application value.In addition,well-designed RCTs can reduce the unnecessary waste during the secondary research on evidence.Finally,international secondary research with well design is also very important to improve the application value of acupuncture RCTs,which can reduce research waste due to the accessibility of research and other reasons during the secondary research. |
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