Supplementary File: Decision tables for general recommendations
Recommendation #1: We strongly recommend that all stakeholders in the knowledge generation and translation process raise awareness about dissemination bias (publication bias) and measures to reduce it. Category Judgment Remark High confidence in effectiveness Yes x No Likely limited effectiveness in the short run, but potentially high effectiveness in the long run Benefits clearly outweigh downsides x Yes No No obvious downsides; potential to have important impact Low likelihood of strong opposition x Yes No Probably no strong opposition, but likelihood of “opposition” due to passiveness/limited resources of key stakeholders x Limited resources required for implementation x Yes No At first only limited resources required; however, relevant resources would be required if this recommendation is implemented on a large scale Easily implementable Yes No Easy to start raising awareness, but comprehensive strategy more difficult to implement Strength of recommendation: x Strong recommendation Recommendation Remark: Not very concrete recommendation; room for interpretation. Should also be extended to patients who should be made aware of dissemination bias. Recommendation #2: We strongly recommend that all stakeholders in the knowledge generation and translation process disseminate and facilitate implementation of targeted OPEN recommendations amongst key stakeholders of their respective group. Category High confidence in effectiveness Benefits clearly outweigh downsides Low likelihood of strong opposition Judgment Remark x Yes No If OPEN recommendations were fully disseminated and implemented, dissemination bias would most likely be reduced effectively. x Yes No Although some specific recommendations might not have a unambiguous beneficial balance, overall benefits would clearly outweigh downsides. Yes x No Likely that some key stakeholder groups or some key stakeholders within a group are opposed and not going to disseminate and/or implement some or all OPEN recommendations. Limited resources required for implementation Yes x No A comprehensive dissemination and implementation plan would likely require substantial resources. Easily implementable Yes x No Likely tailored dissemination and implementation strategies would be required including monitoring efforts on implementation and effectiveness. Strength of recommendation: x Strong recommendation Recommendation Remark: Strong recommendation despite concerns around opposition, resources and implementability; but obviously key recommendation amongst OPEN recommendations. Without dissemination and implementation plans, OPEN recommendations will be not helpful in reducing dissemination bias. Recommendation #3: We strongly recommend that all stakeholders in the knowledge generation and translation process promote trial registration and support initiatives that facilitate searches across multiple trial registries. Category Judgment Remark High confidence in effectiveness x Yes x No Promotion and support in itself likely not yet highly effective in reducing dissemination bias, but if respective initiatives are implemented and maintained relevant impact likely in the longer run. Benefits clearly outweigh downsides x Yes No No obvious downsides in promoting trial registration and supporting such initiatives. Low likelihood of strong opposition Yes x No Some opposition by groups active in this field quite likely. Limited resources required for implementation x Yes No Promotion and political support possible without relevant resources. Technical consequences not fully clear; relevant resources likely required to establish, promote, expand and maintain such initiatives. Easily implementable x Yes No No serious barrier to both political and financial support was identified. Strength of recommendation: x Strong recommendation Recommendation Remark: Wide range of support is possible. Although not very concrete, strong recommendation in favour of supporting and thereby hopefully establishing/maintaining in the longer run respective initiatives (one example of such a platform is the WHO International Clinical Trials Registry Platform (ICRTP)). Likely need for alternative initiatives to avoid monopoly?! In the future need for similar initiatives that allow simultaneous access to results databases. Recommendation #4: We strongly recommend that all stakeholders in the knowledge generation and translation process support activities to systematically synthesize information from studies with rigorous methodology. Category Judgment Remark Yes x No Support in itself likely not yet highly effective in reducing dissemination bias, but if respective activities rigorously identify and integrate unpublished trials likely relevant impact in the longer run. Benefits clearly outweigh downsides x Yes No Risk of spurious conclusions if activities based on very biased subset of published trials; overall benefits seem to clearly outweigh downsides, in particular if efforts are undertaken to consider all conducted research for a specific question. Low likelihood of strong opposition x Yes No No strong opposition to general support likely; however, financial support more likely to be difficult to establish. x Yes No Political support possible without relevant resources. Relevant resources likely required to increase and maintain efforts to actually conduct and regularly update all these activities (SRs). High confidence in effectiveness Limited resources required for implementation No serious barrier to both political and financial support was identified. Easily implementable x Yes No Strength of recommendation: x Strong recommendation Recommendation Remark: Wide range of support is possible. Although not very concrete, strong recommendation in favour of supporting and thereby increasing such activities. However, relevant resources will be required in the long run to conduct and update regularly relevant systematic reviews. Dissemination strategies need to be developed for non-­‐English speaking countries to increase effectiveness. These will require further resources.