Evi Germeni

ObjectiveThe use of qualitative research with randomized controlled trials (RCTs) has grown exponentially over the last decade, but little is known about how it is contributing to trial procedures and interventions. This review systematically mapped the value that qualitative research has had in RCTs of drugs and medical devices.MethodsWe searched five electronic databases (MEDLINE, EMBASE, PsycINFO, CINAHL, and ASSIA) and the NIHR Journals Library to identify original, peer-reviewed qualitative research conducted in the context of specific RCTs (pilot or full). Drawing on studies published between January 2019 and December 2020, we identified and classified examples illustrating how qualitative research had contributed to the trial. This created a list of questions qualitative methods can address in RCTs.ResultsOf 207 included studies, only 22 percent explicitly articulated their value. Most frequently reported contributions included: (a) explaining trial findings; (b) ensuring that interventions meet the needs of key stakeholders; and (c) making the trial feasible and viable (e.g., through improved trial design and conduct). A total of 776 examples demonstrating how qualitative methods had enhanced the trial were classified into twenty-seven subcategories. A list of sixty potential questions was developed to assist future research design.ConclusionsThe value of qualitative research in trials is expanding. While qualitative methods have traditionally been associated with complex interventions, this review highlights their relevance to trials involving drugs and devices. Future trials could benefit from expanding the use of qualitative methods to deepen understanding of outcomes, strengthen measurement validity, and capture experiences of conditions.

Objectives: This study aims to explore the perspectives on disinvestment of low-value care and interventions in Malaysia’s healthcare system, with a focus on establishing the criteria for assessing disinvestment candidates, identifying potential barriers, and proposing strategies to improve the acceptance and effective implementation of disinvestment. Methods: Between March and May 2023, we conducted online, semistructured interviews with seventeen Malaysian healthcare stakeholders with different professional roles at various levels of governance and decision making. Participants were recruited through a mix of purposive and snowballing sampling. Interviews were transcribed verbatim and analyzed using inductive thematic approach in Atlas.ti. Results: We identified four major themes: disinvestment as a catalyst for efficient resource allocation ; disinvestment as a justifiable way of cutting budgets ; challenges and barriers in implementation ; and strategies for value-based assessment and effective implementation. Stakeholders viewed disinvestment both optimistically and skeptically in terms of its implementation but were unanimous in including equity as a key component in decision making. Practical challenges and uncertainty among healthcare professionals emerged as significant barriers to implementing disinvestment initiatives in Malaysia. Conclusions: Malaysian stakeholders viewed disinvestment as both an opportunity to improve resource allocation and a source of concern due to potential negative consequences and system readiness. This study identified strategies to support value-based assessment and implementation, underscoring the need for accountability and collaboration. Although current disinvestment efforts in Malaysia remain limited and undocumented, the thematic framework developed offers transferable insights and a structured lens for assessing readiness. These stakeholder-derived themes can guide other countries in designing transparent, equitable, and context-sensitive disinvestment processes.

Background: Adults with learning disabilities face increased risks of unhealthy lifestyle behaviours, including alcohol consumption, smoking, low physical activity, sedentary behaviour and poor diet. Lifestyle modification interventions that target health-risk behaviours can prevent or reduce their negative effects. The goal of this project was to investigate the effectiveness and underlying mechanisms of lifestyle modification interventions in adults with learning disabilities. Methods: A systematic review and meta-analysis were conducted to determine the effectiveness of lifestyle modification interventions and their components in targeting health risk behaviours in adults with learning disabilities. Major electronic databases, clinical trial registries, grey literature, and citations of systematic reviews and included studies were searched in January 2021 (updated in February 2022). We included randomised and non-randomised controlled trials targeting alcohol consumption, smoking, low physical activity only, sedentary behaviour and poor diet in adults (aged ≥ 18 years) with learning disabilities. Studies were also coded based on the extent of use of theories and behaviour change techniques in interventions. Risk of bias in studies was assessed using appropriate tools. A realist synthesis of qualitative, quantitative and mixed-methods literature was conducted to complement the systematic review findings by identifying key intervention mechanisms that are likely to improve the health of adults with learning disabilities. Data were synthesised in the form of a programme theory regarding complex causal mechanisms and how these interact with social context to produce outcomes. All findings were integrated into a logic model. A patient and public involvement group provided input and insights throughout the project. Results: A total of 80 studies with 4805 participants were included in the systematic review. The complexity of lifestyle modification interventions was dismantled by identifying six core components that influenced outcomes. These components could be present in interventions targeting single or multiple health risk behaviors, either as individual elements or in various combinations. Interventions on alcohol and smoking behaviours were found to be effective, but this was based on limited evidence. The effectiveness of interventions targeting low physical activity only or multiple behaviours (low physical activity only, sedentary behaviours and poor diet) was mixed. All interventions had a varying level of statistical significance. The intervention-level network meta-analysis for weight management outcomes showed none of the interventions was associated with a statistically significant change in outcomes when compared to treatment as usual and each other. Similar findings were observed in the component network meta-analysis. A variety of theories and behaviour change techniques were employed in the development and adaptation of interventions. Most studies had a high and moderate risk of bias. A total of 79 studies, reporting the experiences of more than 3604 adults with intellectual disabilities and over 490 caregivers, were included in the realist synthesis. The resulting programme theory highlighted the contexts and mechanisms relating to support involvement, negotiating the balance between autonomy and behaviour change, fostering social connectedness and fun, the accessibility and suitability of intervention strategies and delivery, along with the broader behavioural pathways to lifestyle change. It also brought out the importance of working with people with lived experiences when developing and evaluating interventions. Our logic model, bringing together the findings of both syntheses, provides guidance on the design of future interventions. Discussion: This study was the first comprehensive mixed-methods evidence synthesis to explore lifestyle modification interventions targeting multiple unhealthy lifestyle behaviours in adults with learning disabilities. We conclude that future research could benefit from codeveloping interventions and population-specific assessment frameworks with people with lived experiences. There is a need for more high-quality research with appropriate outcomes and a focus on qualitative and mixed-methods research to better understand what works for whom and why. Trial registration: This trial is registered as PROSPERO CRD 42020223290. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR128755) and is published in full in Health Technology Assessment; Vol. 29, No. 4. See the NIHR Funding and Awards website for further award information.

Introduction: Based on the United Nations’ sustainable development goals, universal access to sexual and reproductive health (SRH) services should be attained by 2030. Yet, large inequalities in adolescent SRH knowledge and service use still exist both within and between countries. The goal of this study was to identify and synthesise published qualitative research on factors affecting young people’s utilisation of SRH services in Asia-Pacific countries. Methods: We systematically searched five electronic databases (MEDLINE, EMBASE, PsycINFO, CINAHL and Web of Science) for qualitative studies reporting the experiences, attitudes and views of young people (aged 10–24 years) regarding the utilisation of SRH services in Asia-Pacific countries. We assessed the quality of identified studies using the Critical Appraisal Skills Programme qualitative checklist and employed a thematic synthesis approach for the data analysis. Results: We included 31 articles that reported the experiences of over 1800 young people from 15 different countries. Thematic synthesis identified six descriptive themes that captured factors influencing SRH service utilisation: (1) navigating puberty; (2) knowledge and beliefs about SRH; (3) embarrassment and confidentiality concerns; (4) low decision-making autonomy; (5) traditional practices and religious beliefs; and (6) social and gender norms. Based on these, we developed an overarching analytical theme, ‘trapped in a legacy of shame’, which highlights the role of shame as a key emotion associated with young people’s utilisation of SRH services. Conclusion: Our findings point towards the necessity of integrating shame-sensitive approaches and a social norms perspective in interventions aiming to improve young people’s SRH outcomes in Asia-Pacific countries. PROSPERO registration number: CRD42023389653.

Objectives: The roles and potential value of patient preference (PP) data in health technology assessment (HTA) remain to be fully realized despite an expanding literature and various efforts to establish their utility. This article reports lessons learned through a series of collaborative workshops with HTA representatives, organized by the Health Technology Assessment International’s Patient Preferences Project Subcommittee. Methods: Five online workshops were conducted between June 2022 and June 2023, seeking to facilitate collaborative learning and reflection on ways that PP data can be integrated into HTA. Participants included nine HTA representatives from the United States, Canada, Australia, England, and the Netherlands. Workshops were recorded, transcribed, and thematically analyzed. Results: Despite appreciating the value of PP data, participants were ambivalent about their use in HTA. Some felt that they were already getting the information they needed from the cost-effectiveness analysis or existing patient involvement processes. Others thought that PP data would be very helpful at the initial and final stage of the decision-making process and, particularly, in the following cases: (a) when technology has important non-health benefits; (b) when the clinical and/or cost-effectiveness evidence is marginal; and (c) when treatment is indicated for a large and heterogeneous population. Issues related to the validity and reliability of PP studies were frequently raised, with preference heterogeneity at the core of these concerns. Conclusions: Collaborating with HTA representatives in the “co-creation” of PP research can help address their concerns and facilitate mutual learning about how PP data can be used in HTA.

Introduction: Social connections in the host country improve International Medical Graduates' (IMGs') well‐being, intercultural competence and performance at work but is an issue that has been largely overlooked in the academic literature and policy discussions. The aim of this study was to better understand the social connections that IMGs form by exploring this phenomenon in a UK context. Methods: IMGs and UK Medical Graduates (UKMGs) practising in Scotland were invited to participate. This was a qualitative study using online semi‐structured interviews for data collection and reflexive thematic analysis. Results: Forty‐one participants were recruited (24 IMGs and 17 UKMGs), selected with maximum variation in terms of gender, ethnicity, speciality, grade and country of primary medical qualification. Twenty‐one (58%) of the participants had experience working in other parts of the UK. Five themes were identified: (i) overcoming early isolation , IMGs strove to overcome their initial social isolation which harmed their mental well‐being; (ii) where connections are made , IMGs form social connections mainly at work and within their religious communities; (iii) seeds of segregation , some IMGs found themselves outside tight UK native friendship groups. Alcohol was a socially exclusive activity for some IMGs, as were other host country cultural norms. Exclusion led IMGs to form social connections with other IMGs or other ‘outsider’ groups; (iv) degrees of Discrimination , discrimination and racism were experienced by some IMGs. Discrimination was individual, structural and institutional, and (v) “ Open (ing) the door” , participants described interventions at organisational, departmental, and individual levels to improve IMGs' ability to form social connections. Discussion: This study highlighted the challenges that IMGs face when trying to form social connections. More emphasis needs to be placed on promoting an environment where social connections, in particular between IMGs and host country natives, can flourish.

Introduction Diagnosing and treating lung cancer in early stages is essential for survival outcomes. The chest X-ray (CXR) remains the primary screening tool to identify lung cancers in the UK; however, there is a shortfall of radiologists, while demand continues to increase. Image analysis by machine-learning software has the potential to support radiology workflows with a focus on immediate triage of suspicious X-rays. The RADICAL study will evaluate Qure.ai’s ‘qXR’ software in reducing reporting time for suspicious X-rays in NHS Greater Glasgow & Clyde. Methods and analysis This is a stepped-wedge cluster-randomised study consisting of a retrospective technical evaluation and prospective clinical effectiveness study alongside the assessment of acceptability via qualitative work and evaluation of cost-effectiveness via a cost utility analysis. The primary objective is to assess the clinical effectiveness of qXR to prioritise patients suspected with lung cancer on CXR for follow-up CT. Secondary objectives will look at the utility, safety, technical performance, health economics and acceptability of the intervention. The study period is 24 months, consisting of an initial 12 month data collection period and a 12 month follow-up period. All the standard care CXRs from outpatient and primary care requests will be securely transmitted to Qure.ai software ‘qXR’ for interpretation. Images with features of cancer will be flagged as ‘Urgent Suspicion of Cancer’ and be prioritised for radiologist review within the existing reporting workflow. Ethics and dissemination The study will follow the principles of Good Clinical Practice. The protocol was granted REC approval in August 2023 from North West—Greater Manchester West Research Ethics Committee (REC 23/NW/0211). This study was registered on clinicaltrials.gov (NCT06044454). An interim report will be produced for use by the Scottish Government. The results from this study will be presented at artificial intelligence, radiology and respiratory meetings and published in peer-reviewed journals. Trial registration number NCT06044454.

This research sought to assess whether and how patient preference (PP) data are currently used within health technology assessment (HTA) bodies and affiliated organizations involved in technology/drug appraisals and assessments. An exploratory survey was developed by the PP Project Subcommittee of the HTA International Patient and Citizen Involvement Interest Group to gain insight into the use, impact, and role of PP data in HTA, as well as the perceived barriers to its incorporation. Forty members of HTA bodies and affiliated organizations from twelve countries completed the online survey. PP data were reported to be formally considered as part of the HTA evidence review process by 82.5 percent of the respondents, while 39.4 percent reported that most of the appraisals and assessments within their organization in the past year had submitted PP data. The leading reason for why PP data were not submitted in most assessments was time/resource constraints followed by lack of clarity on PP data impact. Participants reported that PP data had a moderate level of influence on the deliberative process and outcome of the decision, but a higher level of influence on the decision’s quality. Most (81.8 percent) felt patient advocacy groups should be primarily responsible for generating and submitting this type of evidence. Insights from the survey confirm the use of PP data in HTA but reveal barriers to its broader and more meaningful integration. Encouragingly, participants believe obstacles can be overcome, paving the way for a second phase of research involving in-depth collaborative workshops with HTA representatives.

Objectives: Qualitative methods allow in-depth exploration of patient experiences and can provide context for healthcare decision making. Frameworks for patient-based evidence in health technology assessment (HTA) are expanding; yet, how extensively qualitative methods are currently used is unclear. This review characterized the extent and quality of qualitative data submitted to National Institute for Health and Care Excellence (NICE) and Canadian Agency for Drugs and Technologies in Health (CADTH) for HTA.Methods: NICE and CADTH submissions from September 2019 to August 2021 were reviewed. Submission characteristics and features of patient-based evidence included within submissions were extracted. The quality of qualitative reporting was assessed using the CASP checklist.Results: Patient-based evidence was included in 83/107 NICE and 119/124 CADTH submissions. A small proportion described qualitative data collection (NICE=14; CADTH=24) and analysis (NICE=6; CADTH=9) methods. One-to-one interviews were the most common data collection method, and thematic analysis was exclusively used. Thirty-three percent of NICE submissions scored >7 yes responses on CASP, versus 78 percent of CADTH submissions.Conclusions: Although patient-based evidence was common in the submissions reviewed, only 14/107 NICE and 24/124 CADTH submissions involved formal qualitative data collection. Use of formal analysis methods was even rarer and reporting tended to be brief. At present, there is little guidance about qualitative evidence most likely to be informative and therefore to potentially impact decision making. Ensuring, however, that qualitative data are collected and analyzed in a systematic, rigorous way will maximize their usefulness and ensure that patient voices are clearly heard.