Experiences and challenges faced by patients with COVID-19 who were hospitalised and participated in a randomised controlled trial: a qualitative study

Lukas Hofstetter, Viktoria Tinhof, Hannah Mayfurth, Amelie Kurnikowski, Vincent Rathkolb, Roman Reindl-Schwaighofer, Marianna Traugott, Sara Omid, Alexander Zoufaly, Allison Tong, Ulrich Kropiunigg, Manfred Hecking, Lukas Hofstetter, Viktoria Tinhof, Hannah Mayfurth, Amelie Kurnikowski, Vincent Rathkolb, Roman Reindl-Schwaighofer, Marianna Traugott, Sara Omid, Alexander Zoufaly, Allison Tong, Ulrich Kropiunigg, Manfred Hecking

Abstract

Objectives: As part of a randomised controlled trial, this qualitative study aimed to identify experiences and challenges of hospitalised patients with COVID-19 during illness and treatment (objective 1: COVID-19-related perspectives; objective 2: trial participation-related perspectives).

Design: Semistructured interviews following a prespecified interview guide, transcribed verbatim and analysed in accordance with the grounded theory process. Investigator triangulation served to ensure rigour of the analysis.

Setting: Interviews were embedded in a multicentre, randomised, active-controlled, open-label platform trial testing efficacy and safety of experimental therapeutics for patients with COVID-19 (Austrian Corona Virus Adaptive Clinical Trial).

Participants: 20 patients (60±15 years) providing 21 interviews from 8 June 2020 to 25 April 2021.

Results: Qualitative data analysis revealed four central themes with subthemes. Theme 1, 'A Severe Disease', related to objective 1, was characterised by subthemes 'symptom burden', 'unpredictability of the disease course', 'fear of death' and 'long-term aftermaths with lifestyle consequences'. Theme 2, 'Saved and Burdened by Hospitalization', related to objective 1, comprised patients describing their in-hospital experience as 'safe haven' versus 'place of fear', highlighting the influence of 'isolation'. Theme 3, 'Managing One's Own Health', related to objective 1, showed how patients relied on 'self-management' and 'coping' strategies. Theme 4, 'Belief in Medical Research', related to objective 2, captured patients' 'motivation for study participation', many expressing 'information gaps' and 'situational helplessness' in response to study inclusion, while fewer mentioned 'therapy side-effects' and provided 'study reflection'. Investigator triangulation with an expert focus group of three doctors who worked at the study centre confirmed the plausibility of these results.

Conclusions: Several of the identified themes (2, 3, 4) are modifiable and open for interventions to improve care of patients with COVID-19. Patient-specific communication and information is of utmost importance during clinical trial participation, and was criticised by participants of the present study. Disease self-management should be actively encouraged.

Trial registration number: NCT04351724.

Keywords: COVID-19; MEDICAL ETHICS; QUALITATIVE RESEARCH.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Thematic schema showing themes and subthemes arising from qualitative analysis. ‘Suggestions for improvement’ were developed by reflecting on the content of the qualitative interviews and through discussions among the clinicians.

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