Beckley Ariane, Glogowska Margaret, Waite Felicity, Bee Penny, Freeman Daniel
Department of Experimental Psychology, University of Oxford, Life and Mind Building, South Parks Road, Oxford, OX1 3RF, UK.
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Trials. 2025 May 30;26(1):180. doi: 10.1186/s13063-025-08882-y.
Treatments for patients diagnosed with psychosis need to be improved. Clinical trials are an important way of assessing the efficacy of new treatments. However, recruiting patients into trials is challenging. This study sought to better understand the reasons for this from the perspective of research assistants.
A qualitative study underpinned by a critical realist ontology and contextualist epistemology.
Research assistants who had recruited patients with psychosis into trials, primarily of psychological interventions, were interviewed. Reflexive thematic analysis was used to identify themes.
Overarching themes representing four types of factors influencing recruitment of patients with psychosis into clinical trials were generated: patient, clinical team, research team, and NHS infrastructure. Patients largely wished to take part in trials but needed time to build trust with research assistants. Clinical teams held the power in suggesting patients for trials; therefore, it was essential for research teams to build strong relationships with clinical staff. Research teams recruiting into trials benefited from lived experience expertise, support systems, and institutional knowledge. A key NHS infrastructure factor was that mental health staff had limited time to consider trials for their patients.
Trial participation needs to be made more accessible to patients with psychosis, who often want to take part but lack opportunities. Methods of increasing accessibility could include identifying and addressing barriers to referral from clinical teams, employing multiple recruitment strategies, and flexible appointment formats. Qualitative research with clinical teams and patients will also help in developing the understanding of barriers to recruitment.
对于被诊断患有精神病的患者,其治疗方法需要改进。临床试验是评估新治疗方法疗效的重要途径。然而,招募患者参与试验具有挑战性。本研究旨在从研究助理的角度更好地理解其原因。
一项基于批判实在论本体论和情境主义认识论的定性研究。
对那些主要招募患有精神病患者参与心理干预试验的研究助理进行访谈。采用反思性主题分析来确定主题。
产生了代表影响患有精神病患者参与临床试验招募的四类因素的总体主题:患者、临床团队、研究团队和国民保健服务(NHS)基础设施。患者大多希望参与试验,但需要时间来与研究助理建立信任。临床团队在推荐患者参与试验方面拥有决定权;因此,研究团队与临床工作人员建立牢固关系至关重要。招募患者参与试验的研究团队受益于实际经验专业知识、支持系统和机构知识。国民保健服务的一个关键基础设施因素是心理健康工作人员考虑为其患者参与试验的时间有限。
患有精神病的患者往往希望参与试验但缺乏机会,需要让他们更易于参与试验。提高可及性的方法可包括识别并消除临床团队转诊的障碍、采用多种招募策略以及灵活的预约形式。对临床团队和患者进行定性研究也将有助于加深对招募障碍的理解。