Title of study

List of authors on publication

Introduction/Background

Give clinical background and rationale for study. Provide results of literature review on the topic. This section (or parts of it) can later be used in the introduction of the results paper.

Study objectives

Explain the objectives of the study in one or two sentences. This should be similar to the last sentence in the introduction of results papers.

The specific study aims are:

xxx

yyy

zzz

etc

Design and Methods

Provide some general information relevant for this study such as the type of study, research questions and hypotheses, comparison groups, study endpoints and the proposed approach to address the study objectives.

Study population

Define the inclusion and exclusion criteria for the study (possibly in a table). Explain the reasons for these criteria.

Data sources

Describe which variables or surrogate variables are needed as outcome measurements and covariates. Specify if other data sources than the Spine Tango data will be used and how/if they are linked. Available variables are listed on. https://www.eurospine.org/quality-assurance/spine-tango-registry/research/

Statistical analysis

Describe the statistical tests that are used for each endpoint/study question. State how the exposures are identified, what are the comparison groups. Describe data management, and the level of type I-error used. Consider specifying sensitivity analyses where appropriate.

Ethical approval

If applicable, say whether ethical approval has been obtained or applied for.

Discussion/Significance

Explain the special features of this study. Why is this study important? What can we learn from the study (regardless of the actual results)? What are the weaknesses and limitations of the proposed study and their methods?