Background
Aim and scope
Methods
Selection of the initial items
Delphi consensus process
Face-to-face meeting
Consultation with advisors
Pilot tests
Results
Delphi process
Consensus meeting, consultation with advisors and the pilot test
Subjects | PRISMA for Acupuncture |
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Title | |
Title | 1* Identify the report as a systematic review, meta-analysis, or both; if applicable, state the specific type of acupuncture treatment, such as manual acupuncture or electroacupuncture. |
Abstract | |
Structured summary | 2† Provide a structured summary including, as applicable: background; objectives; data sources; study eligibility criteria, participants, and interventions; study appraisal and synthesis methods; results limitations; conclusions and implications of key findings; systematic review registration number. |
Introduction | |
Rationale | 3* Describe the rationale for what is already known about acupuncture for the target condition in the background; if applicable, state what is already known about the specific types of acupuncture to be studied, and describe whether there is any difference of the effects among different types of acupuncture. |
Objectives | 4† Provide an explicit statement of questions being addressed with reference to participants, interventions, comparisons, outcomes, and study design (PICOS) |
Methods | |
Protocol and registration | 5† Indicate if a review protocol exists, if and where it can be accessed (e.g., web address), and, if available, provide registration information including registration number. |
Eligibility criteria | 6† Specify study characteristics (e.g., PICOS, length of follow-up) and report characteristics (e.g., years considered, language, publication status) used as criteria for eligibility, giving rationale. 6a.1‡ Describe the diagnostic criteria of the target condition in Western medicine. 6a.2‡ If applicable, describe the diagnostic criteria in terms of Traditional Medicine, such as Traditional Chinese Medicine. 6b‡ Describe the types of acupuncture to be included, such as traditional acupuncture, electroacupuncture, or fire acupuncture. 6c‡ If applicable, report measures for therapeutic effects using the terminology of either traditional medicine (e.g. syndrome score for syndrome remission) or Western medicine (e.g. pain intensity). |
Information sources | 7* Describe all sources of information (e.g., databases with dates of coverage, contact with study authors to identify additional studies) in the search, and report the date of the last search. If applicable, report the databases or complementary search methods for acupuncture or traditional medicine. |
Search | 8* Present full electronic search strategy for at least one commonly used database (e.g. MEDLINE), including any limits used, such that it could be repeated. If applicable, include the full search strategy for at least a Western and a traditional medicine database for each systematic review where both were used. |
Study selection | 9† State the process for selecting studies (i.e., screening, eligibility, included in systematic review, and, if applicable, included in the meta-analysis). |
Data collection process | 10† Describe method of data extraction from reports (e.g., piloted forms, independently, in duplicate) and any processes for obtaining and confirming data from investigators. |
Data items | 11* List and define all variables for which data were sought (e.g., PICOS, funding sources) and any assumptions and simplifications made; describe data items about details of acupuncture interventions and controls (e.g., sham acupuncture) referring to TIDieR when applicable. |
Risk of bias in individual studies | 12† Describe methods used for assessing risk of bias of individual studies (including specification of whether this was done at the study or outcome level), and how this information is to be used in any data synthesis. |
Summary measures | 13† State the principal summary measures (e.g., risk ratio, difference in means). |
Synthesis of results | 14† Describe the methods of handling data and combining results of studies, if done, including measures of consistency (e.g., I2) for each meta-analysis. |
Risk of bias across studies | 15† Specify any assessment of risk of bias that may affect the cumulative evidence (e.g., publication bias, selective reporting within studies). |
Additional analyses | 16† Describe methods of additional analyses (e.g., sensitivity or subgroup analyses, meta-regression), if done, indicating which were pre-specified. |
Results | |
Study selection | 17† Give numbers of studies screened, assessed for eligibility, and included in the review, with reasons for exclusions at each stage, ideally with a flow diagram. |
Study characteristics | 18* For each study, present characteristics that were extracted (e.g., study size, PICOS, follow-up period) and provide the citations of the included studies. Summarize details of the acupuncture intervention for each study in a table referring to TIDieR. 18a‡ Describe details of “De-qi” after acupuncture reported in the included studies. |
Risk of bias within studies | 19† Present data on risk of bias of each study and, if available, any outcome-level assessment (see item 12). |
Results of individual studies | 20† For all outcomes considered (benefits or harms), present, for each study: (a) simple summary data for each intervention group and (b) effect estimates and confidence intervals, ideally with a forest plot. |
Synthesis of results | 21† Present results of each meta-analysis done, including confidence intervals and measures of consistency. |
Risk of bias across studies | 22† Present results of any assessment of risk of bias across studies (see item 15). |
Additional analysis | 23† Give results of additional analyses, if done (e.g., sensitivity or subgroup analyses, meta-regression [see item 16]). |
Discussion | |
Summary of evidence | 24† Summarize the main findings including the strength of evidence for each main outcome; consider their relevance to key groups (e.g., health care providers, users, and policy makers). |
Limitations | 25† Discuss limitations at study and outcome level (e.g., risk of bias), and at review level (e.g., incomplete retrieval of identified research, reporting bias). |
Conclusions | 26† Provide a general interpretation of the results in the context of other evidence, and implications for future research. |
Funding | |
Funding | 27† Describe sources of funding for the systematic review and other support (e.g., supply of data); role of funders for the systematic review. |
Title
1* Identify the report as a systematic review, meta-analysis, or both; if applicable, state the specific type of acupuncture treatment, such as manual acupuncture or electroacupuncture.
The title should clearly reflect the objectives of the systematic review and ideally allow the readers and users to identify the population, intervention, comparison, outcome and study design [24]. If the study investigates the effect of a specific style of acupuncture on a particular condition, it should be stated in the title. If a systematic review is planned to examine a large category of interventions including acupuncture (e.g. non-pharmacological interventions [25]), it will be not necessary to mention acupuncture in the title
Rationale
3* Describe the rationale for what is already known about acupuncture for the target condition in the background; if applicable, state what is already known about the specific types of acupuncture to be studied, and describe whether there is any difference of the effects among different types of acupuncture.
As recommended by the Cochrane Handbook [26], the current state of the guideline’s application, significance, and the specific methods of acupuncture for the target disease, as well as the hypothesis and theoretical basis (e.g. the likely physiological mechanisms of acupuncture stimulation), should be clearly described in the Background/Introduction section. The authors could consider including a mini-review of existing systematic reviews on the chosen topic, summarizing the strengths and weaknesses of existing reviews and explain how the newly proposed review will address the weaknesses if applicable. If such reviews do not exist, this should be stated in the background section.
Inclusion and exclusion criteria
6 † Specify study characteristics (e.g., PICOS, length of follow-up) and report characteristics (e.g., years considered, language, publication status) used as criteria for eligibility, giving rationale.
6a.1‡ Describe the diagnostic criteria of the target condition in Western medicine.
Diagnostic criteria are important to define a disease, and thus to clarify the population of interest. As there may be different diagnostic criteria for one condition, and the diagnostic criteria may change over time, this may result in different inclusion criteria of the participants. For example, a systematic review on acupuncture for hypertension used a blood pressure above 140/90 as inclusion criteria, which is the threshold for high blood pressure according to the editions of the American Heart Association guidelines published during the past 14 years [27]. But in 2017, AHA changed its threshold as 130/80 [28]. Reporting the diagnostic criteria with supporting literature being referred can help to clarify the scope of the systematic review.
6a.2‡ If applicable, describe the diagnostic criteria in terms of traditional medicine, such as traditional Chinese medicine.
Acupuncture is a type of traditional medicine, and therefore research in acupuncture sometimes uses diagnostic criteria and syndrome classification in terms of traditional medicine, which often differ from those in Western medicine. This information is however often omitted in the final report. Authors should report the diagnostic criteria according to traditional medicine when using these classifications to include patients.
6b‡ Describe the types of acupuncture to be included, such as traditional acupuncture, electroacupuncture, or fire acupuncture.
The types of acupuncture interventions are diverse, including traditional acupuncture (i.e. manual acupuncture with classical needle manipulation), electroacupuncture, ear acupuncture, scalp acupuncture, wrist-ankle acupuncture, and others [29]. The effect of different types of acupuncture can differ from each other [30, 31], and the effect of acupuncture interventions may change by stage of the disease [32]. Systematic reviewers should clarify which types of acupuncture will be included for analysis. In addition, the adjunctive therapies including moxibustion, cupping, herbal injections, heat lamps or guasha should also be clarified if used as eligible criteria.
6c‡ If applicable, report measures for therapeutic effects using the terminology of either traditional medicine (e.g. syndrome score for syndrome remission) or Western medicine (e.g. scales for pain intensity).
Measures for therapeutic effects in both traditional medicine [33] and Western medicine are important to understand how acupuncture works. If authors took such outcomes as eligibility criteria, they should describe the possible measurements of such outcomes in the inclusion and exclusion criteria, because many outcomes can be defined with varying measurements. For example, pain intensity has four commonly used measurement scales [34].
Information sources
7* Describe all sources of information (e.g., databases with dates of coverage, contact with study authors to identify additional studies) in the search, and report the date of the last search. If applicable, report the databases or complementary search methods for acupuncture or traditional medicine.
Many databases focusing specifically on acupuncture or traditional medicine have become increasingly mature, and they can provide a considerable amount of information for Traditional Chinese Medicine (TCM), Korean medicine and Japanese traditional medicine [35]. Additionally, in some non-English-speaking countries, especially in China, abundant acupuncture-related research continues to be published in local language, and this literature can usually be found in country-based databases only. It is therefore necessary to provide the source when used [36].
Literature searches
8* Present full electronic search strategy for at least one commonly used database (e.g. MEDLINE), including any limits used, such that it could be repeated. If applicable, include the full search strategy for at least a Western and a traditional medicine database for each systematic review where both were used.
The search strategy is an indispensable part of a systematic review. Currently, there are only few studies on how to search literature on acupuncture in specific TCM databases. The authors of the systematic reviews should develop search strategies that are rigorous and repeatable and provide a clear description for at least one commonly used database (like MEDLINE) and, when applicable, one acupuncture- or traditional medicine-tailored source, like the Allied and Complementary Medicine Database (AMED) and AcuTrials® (http://acutrials.ocom.edu).
Data items
11* List and define all variables for which data were sought (e.g., PICOS, funding sources) and any assumptions and simplifications made; describe data items about details of the acupuncture interventions and controls (e.g. sham acupuncture) referring to TIDieR when applicable.
In acupuncture, the effect is associated with several details of intervention, such as the type of needle and angle and depth of inserting, number of needles, duration of treatment, and acupoints, which vary between diseases [37, 38]. In addition, many researchers used sham acupuncture as a control to avoid nonspecific placebo effect and bias caused by the lack of blinding [39]and the design essentially depends on three factors: position, depth of the needle, and auxiliary tools [40‐42]. The TIDieR checklist [43] provided a detailed guideline of intervention reporting, acupuncture systematic review authors could define the extraction items of acupuncture interventions referring to TIDieR.
Study characteristics (one extended item)
18* For each study, present characteristics that were extracted (e.g., study size, PICOS, follow-up period) and provide the citations of the included studies. Summarize details of the acupuncture intervention for each study in a table referring to TIDieR
This information corresponds to the item on data extraction, and should be presented with corresponding results referring to TIDieR items. If the information is insufficiently reported and cannot be obtained by contacting authors of the included studies, then authors should describe this information as “not reported” in their review.
18a ‡ Describe details to refer to typical sensations associated with needling after acupuncture reported in the included studies.
"De-qi" refers to the sensations typically associated with needling including soreness, numbness, heaviness, distension and aching at the insert position when the needle is inserted into acupoints of a certain depth during needling [44]. Seeking De-qi, as well as the time and strength of Qi feeling, affects the clinical efficacy of acupuncture [45, 46]. The current research on De-qi is getting increasingly mature with a growing number of studies being conducted. Systematic reviews should therefore extract and report this information together with how De-qi sensation was measured (e.g. specific scales) from the included studies if available, because there are different scales to quantify De-qi sensations, of which the rationales may not completely agree with each other [47]. Considering the controversies on the relation of De-qi and therapeutic effect, to provide De-qi details could provide future researchers with needed information to further exploration.