Exploring the conduct and reporting of qualitative research in trials using mixed methods

Background The benefits of using qualitative research in trials (QRT) have been demonstrated and it is commonly used. However, the prevalence of QRT and issues with its conduct have been highlighted. Underpinned by a pragmatic approach, this study aimed to explore the use of QRT and identify factors that influence its implementation and reporting. Methods A convergent mixed methods design which included five components 1) a systematic review of 1,492 registered trials that report using qualitative research (1999-2016), 2) a critical review of 2,343 publications reporting QRT (2011-2017), 3) a narrative synthesis which involved the thematic analysis of 23 publications (2011-2020), 4) a case study of three trials which used qualitative research. The case study included nine interviews with members of the case study trial teams as well as 149 trial documents, and 5) the development and piloting of two quality appraisal checklists for QRT reporting. Findings The use of QRT has increased over time, but overall usage remains low. Use is limited to trials investigating behavioural interventions, those conducted in rich Western countries and in trials in co-morbidity conditions, oncology, and mental health. Overall reporting quality for QRT appears to be good but is variable with some areas of reporting being poorer. Engagement with QRT depends on people understanding it and seeing its value. Embedding qualitative researchers within the trial team, good collaborative relationships, consideration of the needs of all trial components and how these relate to each other and being flexible can help to overcome methodological tensions and ensure successful QRT. Conclusion Researchers and other stakeholders involved in trials need to recognise the benefits that QRT can bring and consider its use in a wide range of health areas, countries and in trials evaluating all forms of interventions. Further recommendations for the planning, conduct and reporting QRT are provided

Qualitative research and its methods in epilepsy: Contributing to an understanding of patients' lived experiences of the disease

This review paper makes the case for the usefulness of qualitative research methods in the context of epilepsy research. It begins with an assessment of the current state of epilepsy literature and identifies gaps especially in the following: research in 'developing' countries and research around surgery for adults with epilepsy. It makes the case that disclosure of people's behaviors, actions, and reactions in different, often complex health-care situations can indicate how they bring meaning to their disease experiences and support needs. It shows the value of encouraging work that clarifies how patients manage their illness and how they understand changes in their health and well-being over the life course of their illness and how health-care professionals and other stakeholder groups care for those with epilepsy. The paper suggests a range of methods for addressing gaps in the literature and highlights a range of data collection, data analysis, and data interpretation and synthesis techniques that are appropriate in this context. It pays particular attention to the strengths of qualitative applications in mixed-methods research using an example from a recent ulcerative colitis drug trial that indicates how they can be integrated into study findings, add rich description, and enhance study outcomes. Ethnographic methodology is also presented, as a way of offering rare access to the 'lived experience' dimension, before the paper concludes with an assessment of the qualitative criteria of credibility, dependability, transferability, and confirmability for judging a study's 'trustworthiness'. The criteria evidence not only the trustworthiness of data and findings but also the ways in which a study has approached any challenges inherent in its research design.7 page(s

Healthcare professionals' views of the use and administration of two salvage therapy drugs for acute ulcerative colitis:a nest qualitative study within the CONSTRUCT trial

OBJECTIVES: Insight into healthcare professionals’ views and experiences of the use of ciclosporin and infliximab as salvage therapies for acute ulcerative colitis (UC) and how this may affect participation in a comparison trial is lacking. The study aimed to capture views and opinions of healthcare professionals about the two drugs within the CONSTRUCT trial. DESIGN: An interview-based qualitative study using Framework Analysis embedded within an open-label, pragmatic randomised trial. SETTING: National Health Service Health Boards and Trusts, including large teaching and district hospitals in England, Scotland and Wales. PARTICIPANTS: Principal Investigators (PIs) for trial sites (who were all consultant gastroenterologists) and nurses responsible for administering and monitoring the salvage therapy drugs across trial sites. 15 PIs and 8 nurses recruited from a range of sites stratified by site recruitment rates were interviewed. RESULTS: Interviews revealed that professionals made judgements regarding the salvage therapies largely based on experience of giving the two drugs and perceptions of effectiveness and adverse side effects. A clear preference for infliximab among nurses was revealed, largely based on experiences of administration and drug handling, with some doctors strongly favouring infliximab based on experience of prescribing the drug as well as patient views and the existing evidence base. Most doctors were more equivocal, and all were prepared to suspend preferences and wait for evidence of effectiveness and safety from the CONSTRUCT trial. PIs also questioned guidelines around drug use and restrictions placed on personal autonomy in delivering best patient care. CONCLUSIONS: Findings highlight healthcare professionals’ preference for the salvage treatment, infliximab in treating steroid-resistant UC, largely based on resource intensive nursing requirements of intravenous administration of ciclosporin. Not all doctors expressed this preference, being more equivocal, and all professionals were content to suspend preferences within the CONSTRUCT trial and recognised the importance of establishing relative effectiveness and safety. TRIAL REGISTRATION NUMBER: ISRCTN 22663589

Wider consultation on Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease

In this article we examine whether an innovative mixed method approach could highlight the positive and challenging effects of a Pulmonary Rehabilitation Programme (PRP) on the Quality of Life (QOL) of patients with Chronic Obstructive Pulmonary Disease (COPD). In 2012, we conducted three consultation workshops in Mid-West Wales, UK, with COPD patients that participated in a PRP, their significant others (e.g. spouses and partners), and healthcare professionals who delivered the PRP. We found that there was a resounding enthusiasm for the content and impact of the programme, particularly in the areas of: increased patient activity, enhanced patient control and confidence, a greater willingness to self-manage treatment, and an increased sense of group belonging. Seven key themes mattered most to our study participants: the patient, physical health, mental health, the programme, professionals and significant others, knowledge and education, and the future. We used these themes to craft a best-practice outcomes document (template) of the benefits and challenges of the PRP to inform and support future service evaluation and delivery.URN: http://nbn-resolving.de/urn:nbn:de:0114-fqs150179En este artículo examinamos si un innovador enfoque de método mixto podría poner de relieve los efectos positivos y desafiantes de un Programa de Rehabilitación Pulmonar (PRP) en la calidad de vida (CDV) de los pacientes con enfermedad pulmonar obstructiva crónica (EPOC). En 2012, realizamos tres talleres de consulta en el centro-oeste de Gales, Reino Unido, con pacientes con EPOC que participaron en un PRP, con personas importantes para ellos (por ejemplo, cónyuges y parejas), y profesionales de la salud que atienden el PRP. Encontramos que había un entusiasmo muy fuerte por el contenido e impacto del programa, en particular en las áreas de: aumento de la actividad del paciente, mayor control y confianza del paciente, una mayor disposición a autogestionar el tratamiento , y un mayor sentido de pertenencia al grupo. Siete temas importaron más a nuestros participantes del estudio: el paciente, la salud física, la salud mental, el programa, los profesionales y otras personas importantes, conocimientos y educación, y el futuro. Utilizamos estos temas para elaborar una plantilla de las mejores prácticas de los beneficios y desafíos de la PRP, para informar y apoyar la futura evaluación y provisión del servicio.URN: http://nbn-resolving.de/urn:nbn:de:0114-fqs150179In diesem Beitrag beschäftigen wir uns mit einem innovativen Mixed-Methods-Ansatz zur Bewertung der positiven und problematischen Effekte eines Rehabilitationsprogramms, das eine verbesserte Lebensqualität von Patient/innen mit chronisch obstruktiver Lungenerkrankung zum Ziel hatte. Hierzu führten wir 2012 drei Konsultationsworkshops in West-Wales durch mit Patient/innen, die an einem solchen Programm teilgenommen hatten, deren Angehörigen und mit Professionellen, die in dem Programm tätig gewesen waren. Die Resonanz war vergleichsweise enthusiastisch, sowohl was Inhalte und was den Impact des Programms angeht, und zwar vor allem mit Blick auf eine vermehrte Aktivität der Patient/innen, auf deren Kontrollgefühl, Zuversicht und Bereitschaft einer verbesserten Selbstfürsorge sowie ein erhöhtes Zusammengehörigkeitsgefühl. Sieben Schlüsselthemen konnten als besonders relevant für die Untersuchungsteilnehmer/innen herausgearbeitet werden: die Patient/innen, physische Gesundheit, psychische Gesundheit, das Programm, Professionale und Angehörige, Wissen und Bildung sowie die Zukunft. Ausgehend hiervon entwickelten wir einen Best-Practice-Vorschlag für die Konzeption und Durchführung von Folgeprogrammen und -Dienstleistungen.URN: http://nbn-resolving.de/urn:nbn:de:0114-fqs15017

Increasing uptake of hepatitis C virus infection case- finding, testing, and treatment in primary care: evaluation of the HepCATT (Hepatitis C Assessment Through to Treatment) trial

Background Hepatitis C virus (HCV) infection is a key cause of liver disease but can be cured in more than 95% of patients. Around 70 000 people in England may have undiagnosed HCV infection and many more will not have been treated. Interventions to increase case-finding in primary care are likely to be cost-effective; however, evidence of effective interventions is lacking. The Hepatitis C Assessment Through to Treatment (HepCATT) trial assessed whether a complex intervention in primary care could increase case-finding, testing, and treatment of HCV.Aim To investigate the feasibility and acceptability of the HepCATT intervention.Design and setting A qualitative study with primary care practice staff from practices in the south west of England taking part in the HepCATT trial.Method Semi-structured interviews were carried out with GPs, nurses, and practice staff to ascertain their views of the HepCATT intervention at least 1 month after implementing the intervention in their practice. Normalisation process theory, which outlines the social processes involved in intervention implementation, informed thematic data analysis.Results Participants appreciated the HepCATT intervention for increasing knowledge and awareness of HCV. Although some initial technical difficulties were reported, participants saw the benefits of using the audit tool to systematically identify patients with HCV infection risk factors and found it straightforward to use. Participants valued the opportunity to discuss HCV testing with patients, especially those who may not have been previously aware of HCV risk. Future implementation should consider fully integrating software systems and additional resources to screen patient lists and conduct tests.Conclusion When supported by a complex intervention, primary care can play a crucial role in identifying and caring for patients with HCV infection, to help stem the HCV epidemic, and prevent HCV-related illnes