The working group included a lead researcher (EN), two researchers experienced with developing PROMs (IA and PW), a patient who has experienced aSAH (AS, a member of the patient organization of patients with an intracranial aneurysm hosted at Radboud university medical center), and a neurosurgeon (JB). The working group made the necessary decisions during the development process of the SOS-SAH.

A focus group interview was scheduled with healthcare professionals involved in the acute in-hospital care, as well as follow-up and rehabilitation treatment, of patients with an aSAH, which informed step 1 of the PROM-cycle (goal setting), step 2 of the PROM-cycle (selection of PROs), and an exploration of some aspects of step 4 of the PROM-cycle (development and testing of the PROM). Neurologists, neurosurgeons, rehabilitation physicians, and specialized nurses from different regions in the Netherlands were contacted to participate in a focus group interview. Five healthcare professionals (Table 1) participated in the focus group interview, led by an experienced moderator. As a second step, two individual interviews were conducted with a neurologist and with a rehabilitation specialist who could not attend the focus group interview. The following topics were discussed: the goal setting for the PROM, the relevant PROs for patients with an aSAH, the ideal timing for completion of the PROM, and the best strategy for the visual representation of the results of the PROM. Afterwards there were no unresolved issues, and a shared general view of healthcare professionals involved with the care for patients with aSAH in the hospital setting was achieved. The semi-structured interviews were recorded and transcribed verbatim. A thematic analysis was performed on the data using ATLAS.ti version 8.4.20. The interviews were coded based on a topic list, and new topics that emerged during the analysis were added to this list. Coding was performed independently by two researchers (EN and IA), and differences in the codes were discussed by these two researchers until a consensus was reached. A summary of the interviews was returned to the participants for comments or corrections.

The characteristics of the interviewees

The literature was screened to identify relevant PROs for patients with aSAH that could be related to symptoms, activities, and participation, according to the International Classification of Functioning, Disability, and Health (ICF) model [16]. This is a framework for describing and organizing information on functioning and disability and conceptualizes a person’s level of functioning as an interaction between health conditions, environmental factors, and personal factors.

The validity of the available PROMs for patients after aSAH was evaluated in a recent systematic review [13]. We used this review to select the PROs and PROMs for this study. Additionally, we searched PubMed for qualitative studies about the outcomes in patients after aSAH (using a qualitative research filter (MeSH term) and keywords “subarachnoid hemorrhage” and “outcome”), and performed a search guided by articles and their references previously included in the national guideline.

For all PROs identified in the literature, we searched for PROMs that captured the outcome and assessed its content validity (including face validity) and the length of the questionnaire. Information on structural validity was used to assess the dimensionality of multi-domain PROMs. Only unidimensional domains were considered potentially suitable to be part of the new PROM.

Eleven patients from three hospitals in the Netherlands were interviewed (Table (Table1)1) by trained interviewers to cover step 2 of the PROM-cycle (selection of PROs), and step 3 of the PROM-cycle (identification and selection of PROMs). These patients were successfully treated for an aSAH less than five years ago, and were selected by their treating physician. They randomly selected patients of different ages, genders, and mRS outcome scores. The topics covered in the interviews were: which PROs are relevant for patients with aSAH, the potential value of using a PROM in their own healthcare following aSAH treatment, the acceptable number of questions for the PROM to keep the questionnaire complete but concise, and the preference of completing a questionnaire on paper or online. The goal of the interview was not to perform an explorative study about all possible PROs experienced by patients successfully treated for aSAH, but more specifically to confirm the relevance of previously detected PROs in the literature and by healthcare professionals, and to discuss any other relevant PROs. The interviewees were asked about the content and comprehensiveness of several existing PROMs, i.e., the domains of the Stroke Specific Quality of Life scale (SS-QoL) [17], the Cognitive and Emotional Consequences of Stroke (CLCE-24) [18], the Hospital Anxiety and Depression Scale (HADS) [19, 20], the Quality of Life after Brain Injury scale (QOLIBRI) [21], the Patient-Reported Outcomes Measurement Information System questionnaire (PROMIS) [22], and the Stroke Impact Scale (SIS) [23]. These PROMs were selected because they have been (partly) validated for use in patients with aSAH (as found in the systematic review [13]) or commonly used in research studying the outcomes of aSAH.

The interviews were recorded, and a verbatim transcript was made. A thematic analysis with a directed approach was performed based on a topic list guided by the interview script. The analysis was performed in ATLAS.ti. Any new themes that emerged during the analysis were added to this topic list.

After developing the preliminary PROM, a cognitive validation study was conducted to evaluate whether the questions of the SOS-SAH were interpreted in the way they were intended (step 4 of the PROM-cycle: testing of the PROM). This enabled the evaluation of whether the selected (domains of) existing PROMs were suitable for use in patients with aSAH, and to assess the comprehensibility of any newly formulated items. Patients with a successfully treated aSAH who attended the outpatient clinic were asked to participate. During the interview, the patients completed the SOS-SAH and shared their thoughts about the purpose and phrasing of the questions and about the comprehensiveness of the SOS-SAH [24]. An interview guide was used for all the interviews, which were transcribed verbatim. The analysis was performed based on a topic list and any new issues that emerged during the analysis were added to this topic list. Based on the results, the working group made the final decision about the removal or adaptation of unclear items, leading to the final version of the SOS-SAH.

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