Protocol title, protocol identifying number, and date.
Name and address of the sponsor/funding agency.
Name and title of the investigator(s) responsible for conductng the research, and the address and telephone number(s) of the research site(s), including explicit responsibilities of each.
Name(s) and address(es) of the clinical laboratory(ies) and other medical departments(s) or instituitions involved in the research including explicit responsibilites.
Background: The background describes the research field and existing knowledge. Most importantly, it explicitly specifies a relevant Gap-of-knowledge and gives a succinct but yet comprehensive answer to why the research needs to be done.
Hypotheses: The core of scientific scrutiny is hypotheses. The research-team needs to formulate one or more explicit hypotheses that can fill the gap of knowledge described in Background.
Aims: The aims should formulate one or more specific research questions that provide a critical test of the hypotheses.
Methods: Methods include the design of the study, the setting, inclusion- and exclusion criteria of participants, a traceable description of all interventions and material involved, study parameters, outcome-measurements, lenght of follow-up, a power analysis and a statistics plan with information on data handling. A flow-diagram is recommended. Safety aspects including recording of adverse events should be described if relevant for the study.
Impact and discussion: This section should describe the rationale and utility of the study. Scientific and methodological issues regarding choice of methods and outcomes can be addressed. The most important issue is how the intended study fills the gap of knowledge, whether findings will be relevant regardless of a positive or negtive result and how they will change or expand neurosurgical knowledge. Ethics and relation to existing theories should be commented.
A link to the following youtube video may help authors with the preparation of their study protocols: