Table 1.

Explicit research aims provided to the 2 independent centers by the YODA Project

Research aims
1. Identify all relevant studies, across all uses and sponsor (i.e., Medtronic sponsored, others).
2. Determine the questions that were addressed by these studies.
3. Evaluate the quality of the studies. Assess the risk of bias associated with the design, conduct, and reporting of each clinical study, including those identified via the systematic review and those provided by Medtronic, and, if present, how bias may have affected assessment of effectiveness and harms.
(a) Assessment of study design and conduct should include evaluation of internal validity, methods used to ascertain outcomes and other policies and procedures for data collection, as well as the integrity of case report form adjudication.
(b) Assessment of study reporting should include selective publication and selective reporting
(c) Summary of these findings should include:
i. What conclusions can be drawn by assessing the full body of data and what gaps in knowledge remain, taking into account results from the evaluation of quality and risk of bias
ii. An assessment of applicability of these studies
4. Conduct meta-analyses from studies identified via the systematic review, if appropriate, and using patient-level data, if possible. If not appropriate there should be another approach to summarizing the data. The analysis should consider the following:
a. For effectiveness, meta-analysis should consider patient-centered outcomes (i.e., quality of life and functional status), as well as surrogate outcomes (i.e., fusion as determined by radiography).
b. For safety, meta-analysis should include local effects such as inflammation, heterotopic bone formation, pain, osteolysis and instability, and downstream or systematic effects such as leg pain and weakness, retrograde ejaculations, and possible increased risk of cancer.