Specialising in Peer-Review and Ethics

Study Protocols

Acta Neurochirurgica will publish selected protocols for prospective observational or randomized controlled trials that are relevant for Neurosurgeons and the journals associated society EANS. We will primarily consider clinical trials. These must be registered at an appropriate online public registry. Study Protocols should be succinct and explicit, and contain an account of the background, hypotheses, aim, and methods of a planned study. Acta Neurochirurgica will consider Study Protocols of proposed or ongoing trials where patient recruitment is not finished or almost completed at the time of submission. Study Protocols will be peer reviewed for scientific relevance, relevance to our readership and methodology. Every study must have institutional IRB and ethics approval. Peer-review for funding for a major extramural grant funding body must be stated.

Study Protocols accepted for publication will be citable and accessible online and in print. Investigators must consent to submit the primary manuscript to Acta Neurochirurgica after the study. Acta Neurochirurgica will peer review the manuscripts and rapidly publish the main study findings unless major deviations from protocol, poor reporting, over interpretation of data or other issues of quality and relevance are at hand.

Abstract: The abstract should summarize the key elements of the protocol under the following four subheadings: Background; Hypotheses, Aim, Methods, Impact and discussion

General Information:

Protocol title, protocol identifying number, and date.

Name and address of the sponsor/funding agency.

Name and title of the investigator(s) responsible for conducting 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 department(s) or institutions involved in the research including explicit responsibilities.

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, length 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 negative result and how they will change or expand neurosurgical knowledge. Ethics and relation to existing theories should be commented.