published since, or not included in, the 2015 review, and address the evidence gaps noted. This is to ensure recommendations relating to the use of shiatsu remain relevant and up to date. Research Protocol HTANALYSTS | NHMRC | EVIDENCE EVALUATION ON THE CLINICAL EFFECTIVENESS OF SHIATSU 14 2 Objectives To conduct a systematic review of RCTs and NRSIs to evaluate the effectiveness of shiatsu in individuals with a described injury, disease, medical condition, or preclinical condition. This will be supplemented with the available evidence for acupressure – a core component of shiatsu - as reported in SRs (of RCTs and pseudo-RCTs). The intent is to evaluate the evidence representative of the populations and conditions commonly seen by shiatsu practitioners in Australia, the intervention(s) commonly used by practitioners, and outcomes that align with the reasons why patients use shiatsu and/or practitioners prescribe shiatsu. Research Protocol HTANALYSTS | NHMRC | EVIDENCE EVALUATION ON THE CLINICAL EFFECTIVENESS OF SHIATSU 15 3 Methods Methods reported in this protocol are based on that described in the Cochrane Handbook for Systematic Reviews of Interventions (31) and relevant sections in the Joanna Briggs Institute Reviewer’s manual (32). Covidence (www.covidence.org), a web‐based platform for producing systematic reviews, will be used for screening citations and recording decisions made. Covidence is compatible with EndNote and Microsoft Excel, which will be used for managing citations and data extraction, respectively. Where appropriate, RevMan (33) will be used for the main analyses and GRADEpro GDT software (www.gradepro.org) will be used to record decisions and derive an overall assessment of the certainty of evidence for each outcome guided by GRADE methodology (6). The final approved review protocol is to be registered on the international prospective register of systematic reviews (PROSPERO). To identify the evidence base for the clinical question a systematic search of published medical literature will be conducted. All potentially relevant studies will be identified after applying prespecified inclusion and exclusion criteria as outlined below. Research Protocol HTANALYSTS | NHMRC | EVIDENCE EVALUATION ON THE CLINICAL EFFECTIVENESS OF SHIATSU 16 3.1 Criteria for considering studies for this review 3.1.1 Types of studies Study design Eligible studies are those designed to examine the effectiveness of shiatsu, or its core component – acupressure – compared to control (placebo or no intervention), or other intervention. The evidence for acupressure and shiatsu will be examined separately. For shiatsu, eligible studies are RCTs and NRSIs. For acupressure, eligible studies are SRs (of RCTs and pseudo-RCTs). Shiatsu The primary study of interest is an RCT. Cluster-randomised trials and crossover trials are also eligible for inclusion, and will be analysed using methods appropriate to the design (see Section 3.3.9) (34). If the method of randomisation is not specifically stated, or not considered strictly random, then the study will be judged to be pseudorandomised. Pseudo-RCTs will be evaluated alongside RCTs, with methods of randomisation examined in the risk of bias assessment and any concerns about risk of bias addressed in the synthesis. Certain NRSIs with design features as outlined in Table 2 are also eligible for inclusion. For NRSIs to be eligible for inclusion, the minimum design features include: • allocation to, or practice of, the intervention occurs by choice (by the participant or other) • the effect of the intervention in individuals (or clusters of individuals or groups) is compared with a contemporaneous control group NRSIs in which the effect of the intervention is compared to a historical (or non-parallel or nonconcurrent) control group are not eligible for inclusion due to concerns regarding risk of bias (e.g. due to residual confounding or unmeasurable changes in clinical practice over time). Single arm studies with either post-test or pre-test/post-test outcomes, cross-sectional studies, case series and case reports are also not eligible for inclusion, as it is too problematic to assess the effect of the intervention in such studies with any confidence (35, 36) . The inclusion of NRSIs is to ensure the evidence review adequately covers the breadth of health conditions and outcomes to inform health policy, particularly in populations or settings where the intervention is either not likely, or not able, to be assessed using a randomised design, or where evidence from RCTs is incomplete for certain populations, settings or outcomes that may be more feasibly evaluated using NRSI (37). This is likely to occur when the length of follow up for the outcome is not feasible for an RCT, or the event rate of the outcome is so small that it requires a population-wide study for a measurable effect to be observed. In rare instances, it may be because of a strong preference for the intervention by prospective participants prevents the conduct of a suitable RCT (38), or the RCT evidence for a particular health condition and outcome is indirect and the question is better answered by available NRSI evidence (39). Eligible NRSIs that are assessed to be at critical risk of bias for one or more domain (see Section 3.3.6) will not be included in the