As Dal-Ré et al. has reported, some self-labelled pragmatic trials have not been properly pragmatically designed,[16] and this tendency is observed among PATs. In the present study, we assessed the pragmatism of PATs and aimed to suggest an appropriate direction for future PATs.
As Ian Ford et al. has stated, few trials are pragmatic in all domains of the PRECIS-2 tool, and most trials show pragmatism in certain domains.[17] In the same manner, acupuncture trials may be designed pragmatically in one or two domains; however, self-labelled pragmatic acupuncture trials need to strengthen their pragmatic methods and report them in detail for each domain of the PRECIS-2 tool with rationale considering the results of this systematic review.
The eligibility, recruitment, organisation, primary outcome, and primary analysis domains were shown to be pragmatic (with a mean value greater than three) for the studies in this analysis. These results are encouraging as acupuncture intervention is commonly used to treat daily life conditions and needs no additional training or qualifications to the institutional qualification needed in each country. For these domains, it would be desirable for researchers to embed a real-world setting in future PATs.
Setting, flexibility:delivery, and follow-up domains were not shown to be pragmatic. Several issues need to be addressed for these domains. For setting, the factors reducing the score in this domain included conduction of some trials in hospitals or specialised centres when the diseases or conditions are usually treated in GPs in real life. Delivering acupuncture itself usually does not require a high degree of a clinical setting. So the location in which the condition or disease that the trial aims to investigate is treated in usual care settings needs to be considered more in PATs. Additionally, as Zwarenstein et al.[10] argued, single centres were not considered completely explanatory in this review; however, the number of centres needs to be expanded to apply the results generally in real-world practice settings. For flexibility:delivery, this domain may be considered the most important factor in PATs; however, the mean was below three and did not show pragmatism in the t-test. The main reasons for this were strict acupuncture delivery protocols that limited the acupuncture points, treatment sessions, cointerventions, and interactions between practitioners and patients. Of course, the specific acupuncture point and treatment sessions can be suggested through cumulative evidence such as the point pericardium 6 for postoperative nausea and vomiting.[18] However, a primary characteristic of acupuncture is individualised and complex treatment[19, 20] and is commonly emphasised in the usual care setting. Even in the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA),[21] descriptions of individualised and pragmatic acupuncture protocols and a certain degree of flexibility are allowed. Future researchers conducting PATs need to be considered in this domain. The follow-up domain was not pragmatic; the principal reason for this was the extensive data collection at follow-up periods as well as the frequency and duration of follow ups. As acupuncture treatment usually deals with the usual day-to-day conditions, follow-ups need to be simplified. Although the primary outcomes were pragmatic in the studies, various secondary outcomes occasionally requiring special equipment and additional assessors reduced the score in this domain. The experimental purpose of clinical trials is important; however, extensive outcome measurements and follow-ups could disturb the pragmatic aim of acupuncture trials.
The flexibility:adherence domain could not be appropriately assessed in this review because of insufficient information in the studies. Along with the recruitment domain for which 31.2% of the studies were left blank, the rate of the score ‘blank’ was 84.9% and relatively higher than other domains, and this tendency was shown in a previous study assessing integrative medicine research.[22] In the real-world setting, methods such as sending messages or making phone calls for upcoming appointments may plausibly be used; however, attendance would not be compulsorily forced. Future PATs should explore this issue in more detail.
The control groups in the studies were experimentally scored and shown to be pragmatic. This serves as evidence that the control group is a feature in pragmatic trials; conversely, as Zwarenstein et al.[10] argued, the placebo-controlled group could be pragmatic in some circumstances, so that the rationale for choosing the sham-controlled group as a control group needs to be further described in future pragmatic acupuncture studies.
The strengths of this systematic review are that it was, to the best of our knowledge, the first study to conduct a comprehensive review of PATs and assess the pragmatism of the trials. In particular, we highlighted the insufficient features of the trials which must be further improved and described in future PATs to help decision makers such as doctors, patients, and policy makers to efficiently utilise the results of future PATs.
The limitations of the review are as follows: 1) Assessment was based on published articles. So if trials were conducted more pragmatically or differently from the articles, the score was able to be changed. This issue will be improved when future articles report more detailed pragmatic methods as well as how real trials are performed according to the extended version of the Consolidated Standards of Reporting Trials statement[23] and in acupuncture the Standards for Reporting Interventions in Clinical Trials of Acupuncture statement;[21] 2) When scoring PRECIS-2 domains, it is unreasonable to recognise that the one-point difference in the domains reflects an exact one-degree difference in pragmatism of the trial. Since this study quantitatively utilised the score from the qualitative information from the studies for descriptive analysis and understanding the status of PATs and used statistical analysis as little as possible, the pragmatism of the individual studies should be interpreted with caution.