ArticleBMJ open2022
Experiences and challenges faced by patients with COVID-19 who were hospitalised and participated in a randomised controlled trial: a qualitative study.
Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04351724 (A Multicenter, Randomized, Active Controlled, Open Label, Platform Trial on the Efficacy and Safety of Experimental Therapeutics for Patients With COVID-19), which is not on this map. Cited by 3 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Randomized, Active Controlled, Open Label, Platform Trial on the Efficacy and Safety of Experimental Therapeutics for Patients With COVID-19 (Caused by Infection With Severe Acute Respiratory Syndrome Coronavirus-2)
Who cites it
3 citing papers in PubMed.
- Article
- The construction and practice of a standardized nursing service system based on the designated hospital for the treatment of COVID-19 in China.Archives of medical science : AMS · 2023Article
- Acceptability and feasibility of home and hospital follow-up in Burkina Faso and Guinea: A mixed-method study among patients of the COVID-19 Coverage-Africa clinical trial.PLOS global public health · 2023Article
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
objectivesAs 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).
designSemistructured 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.
settingInterviews 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).
participants20 patients (60±15 years) providing 21 interviews from 8 June 2020 to 25 April 2021.
resultsQualitative 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.
conclusionsSeveral 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.
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