How to create a good research? It is easy, just read the cookbook.

Speaking about research is like talking about cooking. In cooking the cookbooks are helpful for prepare appetizing dishes after  with a careful selection of ingredients and timing, not least the search should be based on sound science and follow guidelines known for some time.

Just as it is better not to cook eggs in the microwave, in research it is better to avoid making blunders as evaluate the effectiveness of a drug / treatment using a drawing inappropriate.

Continuing the similarities between the kitchen and the search is possible to think in drafting the protocol as the practical act of preparation. Many protocol are badly prepared!
The main weaknesses identified in the protocols are summarized as follows:

Tetzlaff JM, Chan A-W, Kitchen J, Sampson M, Tricco A, Moher D. Guidelines for randomized clinical trial protocol content: a systematic review. Syst Rev. 2012; 1:43.

Other difficulties are related to:

• Continued substantial amendments, proposed even when presenting the research to AIFA and the EC
• The difficulty in interpreting the results
• Reporting inappropriate
• The underreporting of adverse events
• The possible negative consequences for the protection of the participants.

To overcome these difficulties in research are freely available for consultation a set of guidelines, all of which to be used for a specific purpose

The SPIRIT: Standard Protocol Items: Recommendations for Interventional Trials, provides a set of recommendations scientific, ethical and administrative provisions for drawing up the protocols of clinical trials.

The document was developed through consultation of 115 stakeholders including researchers, health professionals, methodologists, statisticians, data managers, commercial sponsors and non-commercial agencies.

It takes account of the most important documents of the research: Tiene conto dei più rilevanti documenti della ricerca:

• Declaration of Helsinki

• CONSORT 2010

• E6 della ICH-GCP

• OMS - International Committee of Medical Journal Editors (ICMJE)

• ClinicalTrials.gov

The document is divided as follows:

• Table 1 - Checklist of items recommended to be included in the Protocol and related documents
• Table 2 - Potential advantages and proposals for action by the different stakeholders to spread the adherence to the 2013 SPIRIT
• Figure - The guideline for research phases
• Explanation and Elaboration.

The checklist attached to the document consists of 33 items constructed of an evaluation process that can be summarized as follows: 

                                

These 33 items cover the following aspects:
► [1-5] Administrative Information
► [6-8] Introduction
► [9-15] Methods: Participants, intervention, outcome
► [16-17] Methods: Assignment intervention (for controlled trials)
► [18-20] Methods: management and analysis of data
► [21-23] Methods: Monitoring
► [24-31] Ethical and dissemination
► [32-33] Appendices

You can find all the information about the SPIRIT in the GIMBE Foundation website - link: http://www.gimbe.org/pagine/927/it/spirit.

The Foundation will make available the Italian translation of the entire document useful to avoid making an omelet.

To finish, A 5 minute video drawing an analogy between good research and a well-prepared meal.