Keywords
Quality of Reporting, Acupuncture, COPD
Quality of Reporting, Acupuncture, COPD
The term “quality of reporting”, has been changed to “completeness of reporting” as “quality” is an ambiguous and problematic word, and to use.
A mistake in the result section in the abstract has been corrected.
Also, several clarifications have been made in the introduction and methods sections.
In the results section, a new paragraph has been added to give an "overall summary" of the results.
Finally, a new paragraph has been added in the discussion section to address possible interventions to improve the completeness of reporting.
See the authors' detailed response to the review by Erik Cobo
See the authors' detailed response to the review by David Blanco
Recent systematic reviews have assessed acupuncture’s efficacy for chronic obstructive pulmonary disease (COPD)1–3. These reviews have concluded that, even though acupuncture could have some benefits, the risk of bias of the included trials is too high to draw any strong conclusion. Risk of bias is certainly a critical aspect in randomised control trials; however, to be able to adequately assess sources of bias, complete information needs to be reported.
Complete and clear information regarding clinical trial methodology is not only essential to adequately assess health research but also for its applicability and reproducibility. This is especially important in complex interventions, such as acupuncture, that can be practiced in many different styles and variations. Aspects such as point selection, depth of the insertion, stimulation method and response sought, which may be very different between practitioners, could have an impact on the therapeutic effect4. Therefore, to be able to replicate an acupuncture intervention in clinical practice or reproduce it in another trial, it is necessary to fully describe how it is applied.
The STandards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines were created to improve the completeness of reporting in acupuncture trials and facilitate transparency in published reports5. These guidelines were updated in 2010 as an extension of the CONsolidated Standards Of Reporting Trials (CONSORT) guidelines6 and consist of 6 key items and 17 subitems addressing aspects such as acupuncture rationale, needling details, treatment regime, other components of the treatment, practitioner background and details about the control or comparator.
Although there is evidence that STRICTA guidelines have helped to improve acupuncture’s reporting, there is still a lot of room for improvement7. This has also been seen in recent publications for some specific conditions such as neurological diseases8–10 or cancer11, concluding that reporting is still suboptimal in these conditions. However, to our knowledge, there is currently no publications regarding the completeness of reporting of acupuncture interventions in COPD trials.
Evaluating the adherence of acupuncture clinical trials for COPD to SRICTA guidelines is crucial to detect underreported subitems and therefore highlight current deficiencies. This will help to improve the reporting of future trials and facilitate their applicability in clinical practice and the reproducibility of future research.
The aim of this study is to comprehensibly evaluate the degree of completeness of reporting for each STRICTA item in randomised trials using acupuncture.
In this study, we used the results of our previous systematic review, which included randomised or quasi-randomised trials using filiform needle acupuncture for COPD2. Published studies were comprehensively searched in the following databases from their inception to May 2019: Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Embase, CINAHL, AMED (Ovid), PEDro, PsycINFO, CNKI, VIP, Wanfang, and Sino-Med. Detailed descriptions of the inclusion criteria, information sources, search strategies and study selections are published elsewhere2 and the protocol is available at http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42014015074.
Data from each trail was extracted independently by two reviewers (CFJ, MSM, MY and CHL) using a standardised data extraction form, and disagreements were solved by consensus.
For data collection and STRICTA assessment, a specific extraction table with instructions of how to assess each of the 16 STRICTA subitems was created by the authors (Extended data12). This extraction table was tested with pilot data of 3 papers to solve disagreements on its understanding and ensure its usability. The data of the pilot test was included in the final analysis.
Our aim was to assess the acupuncture interventions, and therefore, the 17th STRICTA subitem “precise description of the control or comparator” was not considered. However, we did include the 16th STRICTA subitem “rationale of the chosen comparator”, since it is critical to justify which component of the acupuncture treatment is being assessed.
Since some STRICTA subitems refer to multiple aspects (e.g., “names of points used” subitem refers not only to the name or location of points but also to if they are used unilaterally or bilaterally), besides considering items just as reported or not reported, we also considered partially reported items and recorded the reasons for there being. This was done to provide more detailed information regarding the aspects that should be improved in the reporting of future trials. Partial reporting was also considered when the authors reported information in other sections, such as the introduction or the discussion. Although some subitems were considered that could potentially be “not applicable” (NA) for some pragmatic designs, none of the trials required this.
In our systematic review, we screened all 5030 unduplicated titles and abstracts retrieved, and obtained 166 full text articles. Finally, we included 28 trials using filiform needles for COPD (Figure 1). Of those, only 6 were published in English-language journals, 1 in a German-language journal and 21 in Chinese-language journals. Details regarding the study characteristics and inclusion process have been published elsewhere2.
Out of the 16 STRICTA checklist subitems analysed, only 4 were considered appropriately reported in more than 70% of the trials; style of acupuncture, variation extent, retention time and frequency and duration of treatment sessions. We also found that 7 other subitems were correctly reported in less than 30% of the trials; depth of insertion, needle type, number of treatment sessions, details of other interventions administered, setting and context of treatment, description of participating acupuncturists and rationale for the control.
Ratings for STRICTA domains are summarized in Figure 2. Details for each trial are shown in Table 1, including reasons for considering partial reporting.
Acupuncture rationale. Acupuncture rationale was considered adequately reported in 20 trials (71%) regarding acupuncture style, 18 trials (64%) regarding reasoning of the treatment and 24 trials (85%) regarding treatment variation. Trials classified with partial reporting mentioned acupuncture style (3 trials) and reasoning (4 trials) in the introduction section but not in the methods section.
Details of needling. Adequate reporting of needling details was very heterogenous along all 4 subdomains. Best reported subdomains were “needle retention time” (21 trials, 75%) and “needle stimulation” (19 trials, 67%). Worse reported items were “name of the points” (10 trials, 35%), “depth of insertion” (8 trials, 28%) and “needle type” (6 trials, 21%). Partial reporting was observed in great proportion in “name of acupuncture points” (16 trials, 57%) being the main reason not describing if points were used unilaterally or bilaterally. Regarding the 46% of the trials classified with a partial reporting in the “needle type” item, there was missing information about the needle manufacturer (32.1%, 9 trials), material (25%, 7 trials) and length and diameter (10.7%, 3 trials).
Treatment regime. While “frequency and duration of the treatment sessions” was considered adequately reported for all trials (100%), the “number of treatment sessions” was considered completely reported in none of them (0%). Although this might seem a contradiction, since the number of treatment sessions can be calculated from the treatment regime, in STRICTA, the number of treatment sessions does not only include the planned number of sessions but also the actual number of treatments received. This information was missing or considered not clear in all trials.
Other components of treatment. Other components of treatment were one of the poorer described items. “Details of other interventions administrated” was only reported in 8 trials (28%) and “settings and context of treatments”, which refers to “instructions to practitioners that might modify their normal practice, for example, prescribing or proscribing explanations to patients about their diagnosis”, were only reported in 2 trials (7.1%).
Practitioner background. This item was only addressed completely in 1 trial (3.5%), and only 2 more trials (7.1%) partially reported it without stating practitioner’s years of experience.
Control or comparator. The “rational of the chosen comparator” was only correctly described in 2 trials (7.1%), while in 2 more trials (7.1%), this was mentioned in the introduction but not in the methods section.
We found important limitations in the completeness of reporting of acupuncture interventions in trials for COPD, especially regarding “depth of insertion”, “needle type”, “number of treatment sessions”, “details of other interventions administered”, “setting and context of treatments”, “description of acupuncturist” and “rationale for the control or comparator” with less than 30% of the trials reporting them completely.
Recently, several similar studies have been published. Lu et al.11 and Hughes et al.13 used STRICTA to evaluate trials with cancer patients, and Wei et al. used STRICTA to evaluate trials with stroke patients8. Although they all concluded that reporting should be improved, there were also some differences. While Hughes et al. found better reporting regarding details of needling and treatment regimen, other reviews found lower reporting on these subitems, especially regarding number of needles per session and depth of insertion. Poor reporting on “details of other interventions administered”, “description of acupuncturist” and “rationale for the control or comparator” subitems was found in all studies.
The differences mentioned above could be due to several reasons. First, Lu’s and Weis’s reviews, as well as our own, included Chinese-language trials, while Hugs’ study included only English-language trials. Trials published in English-language journals seem to have greater completeness of reporting than those in Chinese-language journals, according to Lu’s review. However, Wei et al. found better reporting of the subitems “treatment reasoning” and “response sought” in Chinese journals and better reporting on “practitioner’s background” in English journals.
Second, since STRICTA does not clearly specify how items should be judged, authors might have used different criteria. For example, regarding the subitem “number of treatment sessions”, the STRICTA statement says that “the actual number of treatments received by participants should be reported in the Results section” not only the planned ones. Whereas in our review, we did not consider that this subitem was fully reported unless this information was explicitly stated; others might have been more permissive. Also, the criteria to consider proper reporting on “other components of treatment” might vary widely between reviewers.
Third, sometimes information might have been reported in sections such as the introduction and the discussion. While some authors might not have given much importance to this, we decided to take it into consideration.
To try to improve the adherence to reporting guidelines several strategies have been proposed including training on the use of the guidelines, improving understanding, encouraging adherence, checking adherence and providing feedback, and the involvement of experts. Unfortunately, the effectiveness of many of those interventions is still unknown14.
To our knowledge, this is the first study to assess the completeness of reporting of acupuncture interventions for COPD. We included all acupuncture trials for COPD published until May 2019 with no language restriction, which is important since we only found 6 acupuncture trials published in English. Also, we did not only assess if STRICTA subitems were adequately reported or not but also analysed partial reporting and its reasons, which might be more helpful for authors to realise what specific information is currently missing.
Limitations of this study include that the STRICTA guidelines are not a rating scale; therefore, there are no clear indications of how to judge each subitem and when to consider it fully reported. This issuer must be addressed in the future by developing a proper completeness of reporting assessment tool for acupuncture interventions. To minimise this problem, each item was assessed by two reviewers independently, and a standardised extraction form was developed to unify reviewers’ criteria. Also, it would have been interesting to compare the completeness of reporting depending on the language of publication, so we could explore differences in journal standards. However, due to the low number of non-Chinese-language publications found (1 in German and 6 in English), we decided not to do so. Finally, STRICTA guidelines are specific for the filiform needle acupuncture technique and are not suitable to assess other interventions. Therefore, we did not include trials using only moxibustion, acupressure or transcutaneous electrical nerve stimulation.
The completeness of reporting of acupuncture interventions in COPD trials according to STRICTA guidelines is suboptimal. Strategies for improving the understanding of the guides for authors, reviewers and journal editors are needed, as well as to improve its implementation.
Figshare: Extended data 1 Extraction form, https://doi.org/10.6084/m9.figshare.11999994.v112.
Data is available under a Creative Commons Attribution 4.0 International license (CC-BY 4.0).
We would like to thank the students from the Beijing University of Chinese Medicine Liu Kexin, Zhang Zixuan, Ming Yang, Gao Jiaqi, Li Yilin, Zhang Zhijia, Luo Lingxiao, Shi Yixin, Zhao Luming, Zhang Bingrui, Zhao Leying, Liu Jinjun, Ding Maoyu, Fan Shixuan and Ren Yiming for participating in the project and helping to define the suitability of the data extraction form. The corresponding author is a PhD candidate at the Universitat Autònoma de Barcelona, Spain.
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Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Clinical trials; Reporting Guidelines; meta-research; research waste
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Journal policies, peer review, reporting guidelines
Is the work clearly and accurately presented and does it cite the current literature?
Partly
Is the study design appropriate and is the work technically sound?
Yes
Are sufficient details of methods and analysis provided to allow replication by others?
Yes
If applicable, is the statistical analysis and its interpretation appropriate?
Yes
Are all the source data underlying the results available to ensure full reproducibility?
Yes
Are the conclusions drawn adequately supported by the results?
Yes
References
1. Stevens A, Shamseer L, Weinstein E, Yazdi F, et al.: Relation of completeness of reporting of health research to journals' endorsement of reporting guidelines: systematic review.BMJ. 2014; 348: g3804 PubMed Abstract | Publisher Full TextCompeting Interests: No competing interests were disclosed.
Reviewer Expertise: Journal policies, peer review, reporting guidelines
Is the work clearly and accurately presented and does it cite the current literature?
Yes
Is the study design appropriate and is the work technically sound?
Yes
Are sufficient details of methods and analysis provided to allow replication by others?
Yes
If applicable, is the statistical analysis and its interpretation appropriate?
Yes
Are all the source data underlying the results available to ensure full reproducibility?
No
Are the conclusions drawn adequately supported by the results?
Yes
References
1. Goodman S, Fanelli D, Ioannidis J: What does research reproducibility mean?. Science Translational Medicine. 2016; 8 (341). Publisher Full TextCompeting Interests: No competing interests were disclosed.
Reviewer Expertise: RCTs, reporting guidelines, causal modeling, meta-researcch
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