SPIRIT 2013 Statement: Defining standard protocol items for clinical trials facilitated by Associate Professor Elaine Beller

SPIRIT 2013: Defining Standard Protocol Items for Clinical Trials

References:

Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin J, Doré C, Parulekar W, Summerskill W, Groves T, Schulz K, Sox H, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: Defining standard protocol items for clinical trials. Ann Intern Med 2013; Online first version. http://annals.org/article.aspx?articleid=1556168

Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin J, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleža-Jerić K, Laupacis A, Moher D. SPIRIT 2013 Explanation and Elaboration: Guidance for protocols of clinical trials. BMJ 2013;346:e7586.

 

Our Approach:

The SPIRIT guidelines give a checklist of 33 items that should be included in clinical trial protocols. We wanted to look at the checklist and discuss particular items. We chose three items where we felt these were poorly done in recent grant applications we have reviewed:

1)      Item 6, background and rationale

2)      Item 12, outcomes

3)      Item 19, data management

 

Discussion of the group:

Background and rationale

The background section of a grant application or protocol is frequently not a systematic or complete representation of the existing evidence. It is often a biased reporting of the literature.

Inclusion of the search strategy was suggested as an improvement.

The rationale is often poorly described. The incremental gain for doing this trial should be outlined (e.g. new extension of the population, different variant of the intervention).

Outcomes

Outcomes should be linked explicitly to the objectives/hypothesis.

We thought of it in the following framework: an outcome as a concept (e.g. diabetic control), the measurement chosen to represent that outcome (e.g. HbA1c), and the way of using that measurement to compare groups (e.g. difference in final value of HbA1c between the groups, adjusted for baseline HbA1c).

We agree with the SPIRIT authors that the clinical relevance of the chosen efficacy and harm outcomes should be given. That is, we should justify our choice of outcomes for this particular setting and stage of knowledge. If using a surrogate (like HbA1c), we should provide justification that it is a good surrogate for clinically-relevant outcomes.

Data Management

This is often weak in grant applications, and could be better used to justify the personnel requested in a grant application. Investigators under-estimate the time needed and technical requirements for good data management. We thought the example in the SPIRT E&E paper was a good one.

Our Conclusions:

We will use the SPIRIT checklist and explanatory paper when we write grant applications and protocols, and in our teaching (e.g. workshops).