evidence synthesis because results from these studies are likely to lead to misinformed judgements about the effect estimate. Research Protocol HTANALYSTS | NHMRC | EVIDENCE EVALUATION ON THE CLINICAL EFFECTIVENESS OF SHIATSU 17 Table 2 Eligible design features of nonrandomised studies of interventions Definition / design features Design features of NRSIs included in the review An experimental study in which people are allocated to the intervention/treatment being studied or a control/placebo group and the outcomes compared. The method of allocation is by choice, availability, or chance. A study in which outcomes from a defined group of people (the cohort) are followed over time, to examine associations between exposure and non-exposure to an intervention or factor under study. Outcome are recorded as they occur. A ‘prospective’ cohort study recruits participants before any intervention and follows them into the future. A study in which outcomes from a defined group of people (the cohort) are identified to examine associations between exposure and non-exposure to an intervention or factor under study. A ‘retrospective’ cohort study identifies subjects from past records describing the interventions received and follows them from the time of those records. A study that uses observations at multiple time points before and after an intervention (the ‘interruption’) is introduced to a group of people, and then compared to the outcomes at the same time points for a group of people that do not receive the intervention. The design attempts to detect whether the intervention has had an effect significantly greater than any underlying trend over time. A study in which observations are made before and after the implementation of an intervention, both in a group that receives the intervention and in a control group that does not and compared at the same timepoint. A study that compares people with a specific outcome of interest (‘cases’) with people from the same source population but without that outcome (‘controls’), to examine the association between the outcome and prior exposure (e.g. having an intervention). This design is particularly useful when the outcome is rare. Source: Adapted from NHMRC (36, 40); Chapter 24 Including non-randomised studies on intervention effects (37); Cochrane Childhood Cancer (41); Acupressure The primary study of interest is a SR of RCTs (and pseudo-RCTs), with or without a meta-analysis. This is because conducting a SR of primary studies of acupressure (i.e. RCTs or NRSIs) is not feasible given the timeframe and resources. As acupressure is a central technique used in shiatsu, evidence from SRs of acupressure will be used to augment the evidence from primary studies of shiatsu. If the method of randomisation of a primary study included within a SR is not specifically stated, or not considered strictly random, then the study will be considered to be pseudorandomised. Where a SR includes pseudo-RCTs, these will be considered as eligible along with data from RCTs. Reviews that do not report study eligibility criteria or conduct a comprehensive search of the literature (i.e. searching more than one database) will not be included. These reviews do not meet the minimum criteria to be considered ‘systematic’ and may not accurately summarise the body of evidence. Eligible reviews that include a single RCT will be included, as will SRs that include both RCTs and NRSIs; however, only evidence from the RCTs (or pseudo-RCTs) will be considered. Information on how meta-analyses from SRs will be handled where they include ineligible studies (e.g. NRSIs that are not pseudorandomised) or where they are missing one or more eligible studies is provided in Section 3.3.11. Additional study designs will not be considered. This includes individual RCTs or pseudo-RCTs not part of a SR, nonrandomised comparative studies (i.e. nonrandomised experimental trials, cohort studies, case-control studies, interrupted times series), cross-sectional studies and case series with Research Protocol HTANALYSTS | NHMRC | EVIDENCE EVALUATION ON THE CLINICAL EFFECTIVENESS OF SHIATSU 18 either post-test of pre-test/post-test outcomes.. Where a SR is not identified for an eligible population or intervention, this will be noted as an evidence gap. Overviews will not be eligible for inclusion and the search strategy (see Appendix A) is not specifically designed to identify them. However, Overviews identified in literature search or those submitted through the Department’s public call for evidence (see Section 3.2.2) will be checked to identify SRs that are eligible. Publication date There are no limitations on publication date, however, studies or systematic reviews published after the literature search date will not be eligible for inclusion. Studies that are published (or submitted to the Department) after the literature search date will be listed within the ‘Studies awaiting classification’ table of the evaluation report. These studies will not be subject to a formal evidence evaluation, however, a brief statement about the study and its potential impact on the overall conclusions of the evidence review will be included under the relevant sections of the review (e.g. ‘Overall completeness and applicability of evidence’). Studies published in languages other than English The literature