Trishna Bharadia

Patient authorship, in particular the inclusion of patient representatives or patient partners as external authors on company-sponsored publications, is increasingly observed1,2. Patients in this c...

Patient engagement (PE) has evolved from an emerging concept to a fundamental ethos underpinning healthcare research and communication. In this commentary, we explore the historical evolution in medical research from patients being participants in clinical trials to becoming integral partners in communicating medical research findings. The progression from "why" to "how" PE should occur represents a fundamental shift in the medical publication landscape. We also highlight the International Society for Medical Publication Professionals' (ISMPP) journey in embracing and advancing PE within medical publications through ISMPP's initiatives and activities, including the establishment of its PE Task Force, patient membership, and support programs, while examining the cultural transformations occurring within the profession. Looking ahead, we discuss opportunities for expanding patient roles, improving accessibility to tools and frameworks, and integrating patient perspectives into leadership positions. This commentary serves as both a reflective narrative and a call to action for medical publication professionals to champion authentic and meaningful PE, ensuring publications truly engage and serve the patients at the heart of the research they describe, as exemplified by ISMPP.

Partnerships between patients and the medical research community are strengthening. Patient involvement in research processes through collaborative workstreams provides authentic insights and perspectives, enhances trust between stakeholders and the patient community, brings balance to authorship groups and adds value and contextualisation to publications. Here, patient advocates, representatives from patient and caregiver communities and pharmaceutical and medical communications professionals propose seven actions to advance patient authorship and collaboration in peer-reviewed publications. Drawing on research, personal experience and professional insight, they call for a shift in conventional publication development practices—from seeking reasons to include patient authors to requiring justification for their exclusion—thereby facilitating greater inclusion and representation of the patient voice. The authors advocate moving beyond the concept of ‘patient-centricity’ towards ‘patient partnership’ to reflect a collaborative approach and more equitable balance of power and benefits among stakeholders. They also emphasise the importance of involving patients holistically in publication steering committees to ensure that the publication landscape includes patient perspectives and represents lived experiences. Continued facilitation and strengthening of partnerships between patient and non-patient authors is noted as essential for improving communication, understanding and equity within authorship groups. To support the visibility and recognition of patient authors, they recommend the use of the ‘patient author’ affiliation metatag to better identify, search, filter and standardise publications with patient involvement, identify patient authors and help build an evidence base from which best practice and guidance can be developed. Additionally, the authors highlight the need to consider and develop guidance around compensation of patient authors to acknowledge the contribution and time commitments across the research process and enable greater diversity, equity and inclusion. Finally, they stress the importance of extending the reach of publications to wider audiences through enhanced accessibility formats and open access. Graphical Abstract

Generative artificial intelligence (gAI) tools and large language models (LLMs) are gaining popularity among non-specialist audiences (patients, caregivers, and the general public) as a source of plain language medical information. AI-based models have the potential to act as a convenient, customizable and easy-to-access source of information that can improve patients’ self-care and health literacy and enable greater engagement with clinicians. However, serious negative outcomes could occur if these tools fail to provide reliable, relevant and understandable medical information. Herein, we review published findings on opportunities and risks associated with such use of gAI/LLMs. We reviewed 44 articles published between January 2023 and July 2024. From the included articles, we find a focus on readability and accuracy; however, only three studies involved actual patients. Responses were reported to be reasonably accurate and sufficiently readable and detailed. The most commonly reported risks were oversimplification, over-generalization, lower accuracy in response to complex questions, and lack of transparency regarding information sources. There are ethical concerns that overreliance/unsupervised reliance on gAI/LLMs could lead to the “humanizing” of these models and pose a risk to patient health equity, inclusiveness and data privacy. For these technologies to be truly transformative, they must become more transparent, have appropriate governance and monitoring, and incorporate feedback from healthcare professionals (HCPs), patients, and other experts. Uptake of these technologies will also need education and awareness among non-specialist audiences around their optimal use as sources of plain language medical information. Plain Language Summary: More and more people are using special computer programs called artificial intelligence (AI) or large language models (LLMs) to find and get medical facts in simple words they can understand. This can help people take better care of themselves, learn about their health, and talk with their doctors. We found that AI/LLMs generally provided correct and helpful information to people. However, there could also be a risk of incorrect or unreliable information in certain situations if the question is complex. This can cause harm to people if they use this information to make their own medical decisions. Also, gAI/LLMs provide human-like responses, which make people trust them more than they should. There could be a risk that people may share their medical information with AI/LLMs, which could get into the wrong hands. To make sure these programs really help people, they need to be clear about how they work, and they must have good rules to follow and take advice from doctors and patients to improve performance. People also need to be trained on how to best use these AI tools to find easy-to-understand and reliable medical information. It is important for doctors, patients and other health workers to help make sure the AI is producing reliable and understandable medical information for patients.

Background and purpose: The rapidly evolving landscape of effective treatment options in multiple sclerosis has led to a shift of treatment objectives towards a treat‐to‐target approach aiming to suppress disease activity below the level of detectability early during the disease. To enable treat‐to‐target, a thorough reappraisal of available outcome measures with respect to their ability in this regard is required.Methods: To that end, we conducted a comprehensive systematic literature review of more than 1000 studies using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta‐Analyses) 2020 methodology focusing on underlying evidence as well as utility and implementability in clinical practice.Results: From there, we propose a set of measurable outcomes for everyday routine clinical practice as well as advanced/aspirational measurables requiring additional resources. We also outline remaining knowledge/technology gaps that need to be overcome to enable a treat‐to‐target approach.Conclusions: This work provides the basis for an evidence‐based definition of outcome targets for relevant stakeholders and regulatory authorities.

Key points: Patient authorship is a new topic in medical publishing, with the number of patient‐authored publications growing rapidly. Publication stakeholders (e.g., editors, publishers, funders, researchers) should be aware of the legitimacy of patient authorship. Practical actions can be taken by different publication stakeholders to encourage and support patient authorship—ethically and effectively. Patient authorship can contribute to enhancing diversity, equity, and inclusion in medical publishing. Research on patient authorship could be strengthened with consensus on publication tagging practices (e.g., affiliation terms) and the use of artificial intelligence. A plain language summary of this article and the GRIPP2 form for reporting patient involvement are available as supplementary information.

This Summary of Research summarizes a previously published discussion between people with multiple sclerosis (PwMS) and their caregivers and healthcare professionals (HCPs) about how to include caregivers in consultations and decisions about multiple sclerosis (MS) care. The aim of the discussion was to help HCPs to understand differences in these relationships so they can adapt the style of consultations to support everyone.

Objectives: We culturally adapted STrAtegies for RelaTives (START), a clinically and cost‐effective intervention for dementia family carers, for Black and South Asian families. It had previously been delivered to family carers around the time of diagnosis, when most people with dementia had very mild, mild or moderate dementia.Methods: We interviewed a maximum variation sample of family carers (phase one; n = 15 South Asian; n = 11 Black) about what aspect of START, required cultural adaptation, then analysed it thematically using the Cultural Treatment Adaptation Framework then adapted it in English and into Urdu. Facilitators then delivered START individually to carers (phase two; n = 13 South Asian; n = 8 Black). We assessed acceptability and feasibility through the number of sessions attended, score for fidelity to the intervention and interviewing family carers about their experiences. We used the Hospital Anxiety and Depression Scale. to examine whether immediate changes in family carers' mental health were in line with previous studies.Results: In phase one we made adaptations to peripheral elements of START, clarifying language, increasing illustrative vignettes numbers, emphasising privacy and the facilitator's cultural competence and making images ethnically diverse. In phase two 21 family carers consented to receive the adapted intervention; 12 completed ≥5/8 sessions; four completed fewer sessions and five never started. Baseline HADS score (n = 21) was 14.4 (SD = 9.8) but for those who we were able to follow up was 12.3 (SD 8.1) and immediately post‐intervention was 11.3 (n = 10; SD = 6.1). Family carers were positive about the adapted START and continued to use elements after the intervention.Conclusions: Culturally adapted START was acceptable and feasible in South Asian and Black UK‐based family carers and changes in mental health were in line with those in the original clinical trial. Our study shows that culturally inclusive START was also acceptable. Changes made in adaptations were relevant to all populations. We now use the adapted version for all family carers irrespective of ethnicity.

Background: Patient-reported outcomes (PROs) are widely measured in multiple sclerosis (MS) studies. However, the quality of instrument development processes varies, raising concerns about the meaningfulness of associated data. Objectives: To review the development of selected PROs commonly used in MS studies, including definitions of the concepts measured, use of conceptual frameworks, and degree of input from people living with MS (PlwMS). To gain insights and recommendations from PlwMS on their experience with these PROs. Methods: We assessed 6 PROs (FSIQ-RMS, modified-FIS, MSQoL-54, Leeds 8-item MSQoL, MSIS-29 and EQ-5D) for alignment with regulatory and scientific requirements on PRO structure/development. PlwMS evaluated the degree to which the PROs reflect disease aspects they perceive important. Results: Definitions, clarifications and conceptualisations of the measurement variables were often lacking. PlwMS were variably involved in PRO development. Ethnic diversity was rarely documented. PlwMS identified individualisation, ease of understanding, time burden, and mode of administration as factors affecting PRO usability. Conclusions: To date, the PRO development process has consistently lacked clear definitions of concepts of interest, use of conceptual frameworks and patient involvement, thereby compromising the validity of data they generate. PRO instrument development must be conducted more robustly to maximise the value of pivotal clinical trials.

The neurogenic bladder is associated with an increased risk of urinary tract infection (UTI), which is a leading cause of hospital admission in people with multiple sclerosis (PwMS) and thus imposes a significant health economic burden on the NHS. The last UK consensus document on the management of the bladder in multiple sclerosis (MS) was published in 2009. This document, based on a consensus panel meeting discussion and literature search, updates that guidance. It presents new, evidence-based recommendations relating to the assessment of the lower urinary tract in PwMS, first- and second-line treatments of impaired voiding, and medications for overactive bladder symptoms. There is also guidance on how to promote patient self-management, including the use of home testing kits and patient-initiated follow-up. A key recommendation is the need for a national bladder pathway for PwMS. The consensus panel had a multidisciplinary membership and included two PwMS with first-hand experience of bladder problems.