Hamming, Alexander L.
van Dijck, Jeroen T.J.M.
Visser, Tjitske
Baarse, Martine
Verbaan, Dagmar
Schenck, Hanna
Haeren, Roel H.L.
Fakhry, Rahman
Dammers, Ruben
Aquarius, René
Boogaarts, Jeroen H.D.
Peul, Wilco C.
Moojen, Wouter A.
Funding for this research was provided by:
Jacobus Stichting
Article History
Received: 10 July 2023
Accepted: 12 February 2024
First Online: 17 February 2024
Declarations
:
: This study is approved by the Medical Ethics Committee Leiden The Hague Delft (METC LDD). The study will be conducted according to the principles of the Declaration of Helsinki (as last modified in October 2013 at the General Assembly in Brazil) and in accordance with the Medical Research Involving Human Subjects Act (WMO).
: Patients that present to one of the participating medical centres (primarily or after referral) will be asked to participate and will be consented after being informed about the study, risks, and advantages of participation to acquire informed consent. This procedure will be done according to the protocol “Samenwerkende Topklinische Ziekenhuizen Standard Operating Procedure Informed Consent”. If an eligible patient is identified, prospective data collection will start. This will be noted in the patient file. The written consent from the patient or legal representative should be obtained during the admission period. Information will be giving both verbally and in writing. After given time for consideration, informed consent will be obtained (from the patient or from a representative). The informed consent form will be signed by both the investigator and the patient or representative and participation in the trial will be registered in the patients’ medical file. Other outcomes of the informed consent procedure will also be logged in the patients’ file. After informed consent, prospective data collection will start. This will be noted in the patient file. If a patient withdraws their consent, all data up to the moment the participant withdrew consent will be used for analysis. If informed consent cannot be obtained from the patient or legal representative before emergency treatment or if the patients is incapacitated at time of inclusion and the legal representative is not available, consent will be assumed, and data acquisition started. The consent procedure will be attempted as soon as a legal representative is available, or the subject becomes competent. If patient or legal representative refuses to participate in the study at a first moment of deferred consent, all data will be destroyed.Some exceptions that are possible on the abovementioned procedure are discussed and a solution is chosen based on both ethical and legal considerations as well as methodological considerations (diminishing of bias). If patients die before the informed consent procedure could be discussed and there is no legally appropriate shared decision making (SDM), no consent is necessary and patients remain included in the study as long as there is no clearly written objection in the chart from the patient against participation in scientific research projects. If patients die and there is a legally appropriate SDM, but there has been no possibility yet to discuss the informed consent procedure, no consent is necessary and patients remain included in the study as long as there is no clearly written objection in the chart from the patient against participation in scientific research projects. In both cases, the reason to deviate from the standard procedure as well as the decision that the patient remains included in the study has to be written clearly in the chart.
: This procedure will be done according to the protocol “Samenwerkende Topklinische Ziekenhuizen Standard Operating Procedure Informed Consent”. If an eligible patient is identified, prospective data collection will start. If the patient is incapacitated at time of inclusion, a representative will be informed about the study and is asked to read the information letter and sign the consent form.In the case a patient becomes capacitated during the research, an information letter and informed consent form is provided, and informed consent of the patient is gained. If the patient refused to participate in the study, all study data will be destroyed. If a patient becomes incapacitated during the study period, informed consent will be gained again from the representative. In case the representative refused to further participate, all data up to the moment the participant became incapacitated will be used for analysis.If a patient of whom the legal representative had previously given consent because of incompetence becomes competent and refuses consent to the trial, acquisition of data will cease and data acquired up until then will be used for analysis. If a subject dies during data acquisition before formal consent was given, consent will be assumed and information will be given to legal representatives on how to actively withdraw their consent.
: Patients will receive normal care during their hospital stay. For study purposes, health questionnaires and functional outcome will be assessed at follow-up. During follow-up, patients will be asked to complete several questionnaires to assess treatment success. These test and questionnaires will take approximately 2 h to complete.Measurements will be done in the hospital, the outpatient clinic, the rehabilitation centre, or in the patient’s home (in the case of patient reported questionnaires). Patients may experience temporary fatigue from completing questionnaires.
: The sponsor/investigator has asked the ethical committee to waive the obligatory liability insurance as described in article 7 of the WMO. This is based on the strictly observational nature of the study and the low possibility of damage occurring caused by the study.
: Not applicable.
: All data will be treated confidentially and coded and will be registered on data registration forms. Data management will be handled at the Department of Neurosurgery of Leiden University Medical Centre. Data will be stored in an electronic data capture and management system. Imaging data from participating centres will be stored separately in a picture archiving and communication system at the main study centre (imaging from admission and 1, 5- and 10-year follow-up). A list that contains the study participant and associated study identification code will be used to identify an individual study participant if necessary. Every study site has a specific identifier, and subjects will be assigned a study code based on an increasing number. This identification code will not be based on the participant’s initials or date of birth. The list that links the study identification code to the study participants will be kept on a designated partition on the hard drive of the research centre. This part will be protected by a password. People who have access to this partition are local researchers and quality monitor appointed by the principal investigator. These procedures comply with the European law: Algemene verordening gegevensbescherming (AVG). All raw data will be collected and stored at the main study site, including the trial master file, investigator site file, informed consent forms, study data and imaging data. The acquired data will be stored for 15 years after the study is finished and will be used for further research if the participant has provided consent for the data to be used in further studies.
: Data monitoring and quality assurance will be handled by the Department of Neurosurgery at Haaglanden Medical Centre. Study monitoring will be done on a yearly basis in each participating centre. An auditing log will be enabled of all study events, changes in study settings and study data. The informed consent forms, the investigator site file and the trial master file, as well as the study data will be monitored.
: JHDB has consultancy relationships with Stryker, a manufacturer of detachable coils and stents used for stent-assisted coiling. RHLH and HS from the MUMC started research on factors that cause DCI after SAH, in collaboration with Neuroplast B.V., a Dutch medical biotechnology company specialised in neurodegenerative diseases. WCP reports that LUMC has received research grants from The European Union seventh Framework Program (grant 602150) for CENTER-TBI, Hersenstichting Nederland (Dutch Brain Foundation) for Net-QuRe and CIAO@TBI. The authors have no other relevant affiliations with any organization or entity that have a financial conflict with the subject matter discussed in the manuscript.