Studies that only evaluate auricular acupressure will be excluded, due to indirectness with shiatsu. b Primary studies evaluating acupressure are excluded from the shiatsu component of the review (SR of RCTs and NRSIs). However, SRs of acupressure will be considered within the Overview of Reviews (SR of SRs) component of the review. Research Protocol HTANALYSTS | NHMRC | EVIDENCE EVALUATION ON THE CLINICAL EFFECTIVENESS OF SHIATSU 20 Comparators There are no restrictions on the type of eligible comparators, noting that the analysis will stratify the evidence into three comparisons: (i) placebo; (ii) no intervention, wait list or usual care (unless active); and (iii) other interventions (inclusive of usual care if considered active). The decision to separate placebo and no intervention has been made to account for any potential placebo effect which may occur. For instance, while sham interventions are designed to be a placebo, some have demonstrable clinical effects (43). Where usual care is poorly described or where usual care is described as an adjunct to shiatsu it will be considered an inactive intervention. Other comparators could include (but will not be limited to) pharmacologic treatments, manual therapies, exercise programs or other forms of physical activity designed to improve health. Co‐interventions such as diet, education programs, lifestyle modification, or medication may be administered simultaneously to the intervention and comparison group. Studies with co‐ interventions that are not provided within the context of shiatsu therapy will be included if all arms of a study receive the same co‐interventions (i.e. the effectiveness of shiatsu is not confounded). Restrictions: Studies comparing different styles, forms, or components of shiatsu with one another (including studies comparing shiatsu with acupressure) will be excluded. 3.1.4 Types of outcome measures Outcome role Outcomes will not be used as a criterion for including studies (or SRs). Outcome domains of interest Outcomes are intended to align with the reasons why patients use the therapy and/or practitioners prescribe the therapy. This includes recovery, rehabilitation, and changes in disease outcomes and symptoms (e.g. pain, joint range of motion, strength, balance, and accepted surrogate outcomes such as HbA1C for diabetes, body mass index for weight gain or loss, lung function tests), health related psychological/behavioural outcomes, health related quality of life, self-reported benefits, symptoms and functional ability, medication use or compliance with conventional medicine treatment; and injury or disease specific prevention outcomes (e.g. falls prevention, smoking cessation). Restrictions: Consistent with the terms of reference of NTREAP, personal health care preferences, patient-reported experience measures (PREMS) (e.g. satisfaction with care), safety, quality and economic outcomes are out of scope. Outcome measures and time points of interest Any effectiveness outcome anticipated to demonstrate a treatment achieves its intended purpose is eligible for inclusion (35, 36). There are no limitations on time points (e.g. short and long term outcomes) or outcome measure (e.g. objective and subjective measures such as clinical and laboratory assessments and patient-reported outcome measures [PROMS], preferably measured using validated tools, are eligible). As there are a broad range of populations eligible for inclusion in the review, it is not possible to prespecify outcomes. All prespecified outcomes measured in each eligible SR, RCT or NRSI will be listed in the ‘Characteristics of included studies’ tables; however, results will only be extracted for Research Protocol HTANALYSTS | NHMRC | EVIDENCE EVALUATION ON THE CLINICAL EFFECTIVENESS OF SHIATSU 21 those outcomes identified as critical or important to the review. For each identified population, results for a maximum of seven critical (or important) outcomes will be reported in GRADE summary of findings (SoF) tables and corresponding evidence statements (see Section 3.3.17). Outcome selection will occur after identification of eligible studies using a prespecified approach. To avoid introducing bias, outcomes will be prioritised by the NTWC, who will be provided with a list of conditions, outcome domains and outcome measurements (including measurement tools and time points) to prioritise. This list will be derived from the outcomes reported in studies identified for inclusion in the review, and, where available, core outcome set/s for a particular condition (identified by searching COMET). Throughout the outcome prioritisation exercise, the NTWC will remain blinded about the characteristics or results of included studies (or SRs) to prevent knowledge of study results or other characteristics (such as study design) from influencing decision-making. In determining the critical and important outcomes, the NTWC will be guided by GRADE (6), and focus on the relevance and validity of outcome measures. Where appropriate, outcome domains reported using different measurement tools will be grouped and reported accordingly (see Section 3.3.8). Outcomes reported at different timepoints will be grouped and considered as follows: short term, intermediate term, long term, or not specified. Determining whether something is considered short,