Patients' perspectives on involvement in general practice: A thematic analysis of free-text comments.

BACKGROUND: General practice (GP) plays a core role in managing the clinical pathways of patients with chronic diseases. Despite well-established knowledge of the benefits of involvement and personalized care, involvement in GP appears to be challenged. This study aimed to explore patient involvement in GP from the patients' perspectives. METHOD: The study involved a questionnaire survey investigating patient involvement in GP from the patients' perspectives. The validated questionnaire includes an open-ended question encouraging responders to provide additional comments regarding their involvement in GP. The results from these comments are presented in this paper. A thematic analysis was applied. RESULTS: Of the 468 responses, 139 included additional comments to the free-text question. Through our analysis, six analytic themes were generated-To be seen, met or heard, To feel safe or not, To be involved or dictated to, Accessibility, COVID-19, and For the resourceful-across 116 codings and 25 descriptive themes. The themes' interwovenness underscores the complexity of both involvement and how it is to live with a chronic disease. Our analysis indicates that involvement in GP is for the resourceful. CONCLUSION: The six themes describing involvement in GP from the perspectives of patients with T2DM and/or COPD were deeply intertwined. Involvement is dependent on being seen, met and heard, all of which contribute to the patients' sense of feeling safe (or not). These aspects are dependent on accessibility to a general practitioner; thus, COVID-19 was a barrier during the data-collection period. Furthermore, it appeared that being resourceful not only contributed to a sense of being involved in GP but was perhaps even a prerequisite for being involved.

Methods for living guidelines: early guidance based on practical experience. Paper 2: consumer engagement in living guidelines.

OBJECTIVES: To describe and reflect on the consumer engagement approaches used in five living guidelines from the perspectives of consumers (i.e., patients, carers, the public, and their representatives) and guideline developers. STUDY DESIGN AND SETTING: In a descriptive report, we used a template to capture engagement approaches and the experiences of consumers and guideline developers in living guidelines in Australia and the United Kingdom. Responses were summarized using descriptive synthesis. RESULTS: One guideline used a Consumer Panel, three included two to three consumers in the guideline development group, and one did both. Much of our experience was common to all guidelines (e.g., consumers felt welcomed but that their role initially lacked clarity). We identified six challenges and opportunities specific to living guidelines: managing the flow of work; managing engagement in online environments; managing membership of the panel; facilitating more flexibility, variety and depth in engagement; recruiting for specific skills-although these can be built over time; developing living processes to improve; and adapting consumer engagement together. CONCLUSION: Consumer engagement in living guidelines should follow established principles of consumer engagement in guidelines. Conceiving the engagement as living, underpinned by a living process evaluation, allows the approach to be developed with consumers over time.

Feasibility of implementing a surgical patient safety checklist: prospective cross-sectional evaluation.

BACKGROUND: The World Health Organization's Global Patient Safety Action Plan 2021-2030 call for attention to patient and family involvement to reduce preventable patient harm. Existing evidence indicates that patients' involvement in their own safety has positive effects on reducing hospitalisation time and readmissions. One intervention reported in the literature is the use of checklists designed for patients' completion. Studies on such checklists are small scale, but they are linked to reduction in length of hospital stay and readmissions. We have previously developed and validated a two-part surgical patient safety checklist (PASC). This study aims to investigate the feasibility of the PASC usage and implementation prior to its use in a large-scale clinical trial. METHODS: This is a prospective cross-sectional feasibility study, set up as part of the design of a larger stepped-wedge cluster randomised controlled trial (SW-CRCT). Descriptive statistics were used to investigate patient demographics, reasons for not completing the PASC and percentage of PASC item usage. Qualitative patient interviews were used to identify barriers and drivers for implementation. Interview was analysed through content analysis. RESULTS: Out of 428 recruited patients, 50.2% (215/428) used both parts of PASC. A total of 24.1% (103/428) of the patients did not use it at all due to surgical or COVID-19-related cancellations. A total of 19.9% (85/428) did not consent to participate, 5.1% (22/428) lost the checklist and 0.7% (3/428) of the patients died during the study. A total of 86.5% (186/215) patients used ≥ 80% of the checklist items. Barriers and drivers for PASC implementation were grouped into the following categories: Time frame for completing the checklist, patient safety checklist design, impetus to communicate with healthcare professionals and support throughout the surgical pathway. CONCLUSIONS: Elective surgical patients were willing and able to use PASC. The study further revealed a set of barriers and drivers to the implementation. A large-scale definitive clinical-implementation hybrid trial is being launched to ascertain the clinical effectiveness and scalability of PASC in improving surgical patient safety. TRIAL REGISTRATION: Clinicaltrials.gov: NCT03105713. Registered 10.04.2017.

Including the child's voice in research from a longitudinal birth cohort: insights from the ROLO young person's advisory group.

BACKGROUND: Public and patient involvement (PPI) through Young Person's Advisory Groups (YPAG) enables children to provide guidance and insight into research activities. PPI is an important characteristic of research, however, to date, most collaboration has been with adults. Also, few YPAGs have been established within the Irish setting. The ROLO (Randomised cOntrol trial of a LOw glycaemic index diet in pregnancy to prevent macrosomia) YPAG was established in July 2020 to identify the research priorities of a group of healthy Irish children who are part of a longitudinal birth cohort. We aimed to describe this process and the key insights to date. METHODS: The ROLO study is a longitudinal birth cohort which has followed-up mother-child dyads at multiple timepoints over 10 years. Mothers actively involved in the study were contacted by the research team to invite their ROLO child and older sibling to participate in the YPAG. Meetings were conducted virtually between July 2020 and February 2022. Researchers encouraged free expression of views amongst the children regarding their research interests. Meetings were recorded, transcribed verbatim and analysed for themes based on the topics most frequently discussed and considered important to participants. RESULTS: In all, seven ROLO children and six older siblings attended four ROLO YPAG meetings. Participants were aged between nine to fifteen years old. Four key themes were identified; study children viewed their identity as part of a longitudinal birth cohort as positive and unique; study children considered the fitness test and body measurements as fun aspects related to their participation; all children considered the impact and use of social media as an important form of communication; and all participants expressed interest in attaining new health-related information and learning opportunities. Children suggested topics such as mental health, future viruses, organ transplants, cancer, and the effect of technology and chemicals on the body were important for future research. CONCLUSION: The ROLO YPAG offers promising scope for continued collaboration. The themes identified from the meetings contribute to a gap in the literature which will guide future research activities, particularly with children, in view of study design, relevance, and by communication strategies. Trial Details: ISRCTN54392969 registered at www.isrctn.com .

The ROLO pregnancy study took place in the National Maternity Hospital in Dublin Ireland. It started in 2007 and ended in 2011. The researchers recorded what women were eating. They also measured the weight of the baby at birth. Since then, ROLO mothers and their children were invited to come back to the study. Now the children of the study are 9­11 years of age.The researchers invited members of the ROLO study to speak with them. They wanted to know what research was important to them. They set up a group called the ROLO Family Advisory Committee in 2017. This group of parents and researchers meet once a year. The group thought it was important to include children as well. They made a new group called the ROLO Young Person's Advisory Group in 2020. The group has 7 ROLO children and 6 older siblings. The members are aged between 9 and 15-years-old. The children and researchers have met four times so far.The researchers found four key themes. Study children saw their identity as being part of a longitudinal birth cohort as positive and unique. Study children liked the fitness test and body measurements. All children thought that social media was an important form of communication. All children were interested in learning new information on how their bodies worked.Involving this group of children is important. It will make our research more relevant. Other researchers who want to involve children can learn from our experience.

How can patient partnership help to improve equality as COVID-19 moves from pandemic to endemic?

One of the stated aims of the National Health Service (NHS) within its constitution is the promotion of equality. However, there is evidence inequality has increased over the last decade and the COVID-19 pandemic has exacerbated this. The current pressures on healthcare mean that there is a case for a shift in approach as we transition to living with endemic COVID-19. This article sets out how putting patient partnership front and centre at an individual, systems and national level has the potential to improve equality and assist the NHS in achieving its founding principles. © 2022 The Authors. Lifestyle Medicine published by John Wiley & Sons Ltd.

"Talking on the Phone Is Very Cold"-Primary Health Care Nurses' Approach to Enabling Patient Participation in the Context of Chronic Diseases during the COVID-19 Pandemic.

Strengthening patient participation is considered a crucial element of primary health care (PHC) nurses' practice when working with chronically ill patients. The COVID-19 pandemic had extraordinary effects on PHC nursing routines and how chronically ill patients' could be involved in their own care. This study investigates the adaptation of Spanish PHC nurses' approaches to supporting the participation of patients living with chronic illness during the COVID-19 pandemic. To reach this goal, we interviewed 13 PHC nurses who practiced in PHC centers in Spain. The interviews were analyzed using thematic coding. Three themes emerged from the descriptions of the nurses: (1) High COVID-19-related workload, decreasing health promotion, and chronic care, (2) Emphasis on patients' and families' self-responsibility, (3) Expanded digital and telephone communication with fewer in-person consultations. Nurses felt especially challenged to uphold the support for vulnerable groups, such as older people or patients without family support. Future research should focus on how the participation of the most vulnerable chronic patients can be supported in the context of the growing relevance of remote care.

Remote working in public involvement: findings from a mixed methods study.

BACKGROUND: This paper considers remote working in patient public involvement and engagement (PPIE) in health and social care research. With the advent of the Covid-19 pandemic and associated lock-down measures in the UK (from March 2020), PPIE activities switched to using remote methods (e.g., online meetings), to undertake involvement. Our study sought to understand the barriers to and facilitators for remote working in PPIE by exploring public contributors' and PPIE professionals' (people employed by organisations to facilitate and organise PPIE), experiences of working remotely, using online and digital technologies. A particular focus of our project was to consider how the 'digital divide' might negatively impact on diversity and inclusion in PPIE in health and social care research. METHODS: We used a mixed method approach: online surveys with public contributors involved in health and social care research, online surveys with public involvement professionals, and qualitative interviews with public contributors. We co-produced the study with public contributors from its inception, design, subsequent data analysis and writing outputs, to embed public involvement throughout the study. RESULTS: We had 244 respondents to the public contributor survey and 65 for the public involvement professionals (PIPs) survey and conducted 22 qualitative interviews. Our results suggest public contributors adapted well to working remotely and they were very positive about the experience. For many, their PPIE activities increased in amount and variety, and they had learnt new skills. There were both benefits and drawbacks to working remotely. Due to ongoing Covid restrictions during the research project, we were unable to include people who did not have access to digital tools and our findings have to be interpreted in this light. CONCLUSION: Participants generally favoured a mixture of face-to-face and remote working. We suggest the following good practice recommendations for remote working in PPIE: the importance of a good moderator and/or chair to ensure everyone can participate fully; account for individual needs of public contributors when planning meetings; provide a small expenses payment alongside public contributor fees to cover phone/electricity or WiFi charges; and continue the individual support that was often offered to public contributors during the pandemic.

This paper looks at remote working in patient public involvement and engagement (PPIE) in health and social care research. When the Covid-19 pandemic began and the UK went into lock-down in March 2020, PPIE activities began to use remote working methods, such as Zoom or Teams online meetings. We co-developed a study to understand the experiences of both public contributors and PPIE professionals, those who are employed to organise PPIE, of working remotely. We were particularly interested in how remote working might affect diversity and inclusion in PPIE in health and social care research. We ran online surveys for public contributors and public involvement professionals and conducted semi-structured interviews with public contributors. We co-produced the study with public contributors to embed public involvement throughout the study. We had 244 respondents to the public contributor survey, 65 for the public involvement professionals survey and conducted 22 qualitative interviews. Due to ongoing Covid restrictions during the research project we could not include people who did not have access to digital tools, and this is a limitation of our project. We found that public contributors generally liked working remotely and, for many, their PPIE activities increased. There were both benefits and drawbacks to working remotely. From our findings, we have made a number of suggestions for how to run remote meetings in PPIE and what to prioritise based on the areas public contributors thought were important (such as one-to-one support).

Limitation of life-sustaining treatment and patient involvement in decision-making: a retrospective study of a Danish COVID-19 patient cohort.

BACKGROUND: The coronavirus (COVID-19) pandemic and the risk of an extensive overload of the healthcare systems have elucidated the need to make decisions on the level of life-sustaining treatment for patients requiring hospitalisation. The purpose of the study was to investigate the proportion and characteristics of COVID-19 patients with limitation of life-sustaining treatment decisions and the degree of patient involvement in the decisions. METHODS: A retrospective observational descriptive study was conducted in three Danish regional hospitals, looking at all patients ≥ 18 years of age admitted in 2020 with COVID-19 as the primary diagnosis. Lists of hospitalised patients admitted due to COVID-19 were extracted. The data registration included age, gender, comorbidities, including mental state, body mass index, frailty, recent hospital admissions, COVID-19 life-sustaining treatment, ICU admission, decisions on limitations of life-sustaining treatment before and during current hospitalisation, hospital length of stay, and hospital mortality. RESULTS: A total of 476 patients were included. For 7% (33/476), a decision about limitation of life-sustaining treatment had been made prior to hospital admission. At the time of admission, one or more limitations of life-sustaining treatment were registered for 16% (75/476) of patients. During the admission, limitation decisions were made for an additional 11 patients, totaling 18% (86/476). For 40% (34/86), the decisions were either made by or discussed with the patient. The decisions not made by patients were made by physicians. For 36% (31/86), no information was disclosed about patient involvement. CONCLUSIONS: Life-sustaining treatment limitation decisions were made for 18% of a COVID-19 patient cohort. Hereof, more than a third of the decisions had been made before hospital admission. Many records lacked information on patient involvement in the decisions.

Making knowledge clips with patients: What learning mechanisms are triggered in medical students?

OBJECTIVE: To prepare medical students for a rapidly changing healthcare landscape, where new means of communication emerge, innovative teaching methods are needed. We developed a project-based learning course in which medical students design audiovisual patient information in collaboration with patients and with students in Communication and Information Sciences (CIS). We studied what learning mechanisms are triggered in medical students by elements of a project-based-learning course. METHODS: In this qualitative study, twelve sixth year medical students that participated in the course were individually interviewed. Data were analyzed according to the principles of qualitative template analysis. RESULTS: We identified four learning mechanisms: Challenging assumptions about patients' information needs; Becoming aware of the origin of patients' information needs; Taking a patient's perspective; Analyzing language to adapt to patients' needs. These learning mechanisms were activated by making a knowledge clip, collaborating with patients, and collaborating with CIS students. CONCLUSION: Collaborating with patients helped students to recognize and understand patients' perspectives. Working on a tangible product in partnership with patients and CIS students, triggered students to apply their understanding in conveying information back to patients. PRACTICE IMPLICATION: Based on our findings we encourage educators to involve patients as collaborators in authentic assignments for students so they can apply what they learned from taking patients' perspectives.

Co-design to increase implementation of insomnia guidelines in primary care.

BACKGROUND: Sleep disorders, including insomnia, are widespread problems, which have increased during the COVID-19 pandemic. Guidelines for the treatment of insomnia prioritize non-pharmacological interventions. Nevertheless, primary care professionals lack well-developed material for patient education, that could help implement the treatment guidelines in Flanders, Belgium. OBJECTIVE: This project's purpose is to develop complementary, written educational material, grounded in the principles of evidence-based practice, for primary care. PATIENT INVOLVEMENT: This co-design project involved patients and health professionals. Special attention was given to including patients with low health literacy, and empowering patients when designing in mixed groups. METHODS: Based on the framework of Sanders and Stappers (2014), data were collected and analyzed in four phases. Pre-design, needs were explored using think-aloud studies and focus groups. Next, for generative purposes, the design studio method was used. Then, evaluation of the prototype happened with another series of think-aloud studies. Finally, post-design, implementation of the product was evaluated with a short survey. RESULTS: Twenty-five participants (10 patients and 15 healthcare professionals) contributed to the development of an educational patient leaflet called Sssssst. How do you sleep (at night)? Out of 30 professionals who received the printed leaflet for use in practice, 17 provided feedback after six months. Generally, the leaflet was well received. Visual design aspects stimulated use in practice. DISCUSSION: Written and visual materials aid primary care professionals to educate patients on sleep and insomnia. This supporting tool also stimulates self-management in patients. Although inspiring and educational for all stakeholders, a co-design approach is no guarantee for the product to "fit all".

Patient participation in electronic nursing documentation: An interview study among home-care patients.

BACKGROUND: Patients are increasingly expected to take an active role in their own care. Participation in nursing documentation can support patients to take this active role since it provides opportunities to express care needs and preferences. Yet, patient participation in electronic nursing documentation is not self-evident. OBJECTIVE: To explore how home-care patients perceive their participation in electronic nursing documentation. METHODS: Semi-structured interviews were conducted with 21 home-care patients. Interview transcripts were analysed in an iterative process based on the principles of reflexive inductive thematic analysis. RESULTS: We identified a typology with four patient types: 'high need, high ability', 'high need, low ability', 'low need, high ability' and 'low need, low ability'. Several patients felt a need for participation because of their personal interest in health information. Others did not feel such a need since they trusted nurses to document the information that is important. Patients' ability to participate increased when they could read the documentation and when nurses helped them by talking about the documentation. Barriers to patients' ability to participate were having no electronic devices or lacking digital skills, a lack of support from nurses and the poor usability of electronic patient portals. CONCLUSION: Patient participation in electronic nursing documentation varies between patients since home-care patients differ in their need and ability to participate. Nurses should tailor their encouragement of patient participation to individual patients' needs and abilities. Furthermore, they should be aware of their own role and help patients to participate in the documentation. PATIENT OR PUBLIC CONTRIBUTION: Home-care patients were involved in the interviews.

Transformative Encounters: A Narrative Review of Involving People Living With HIV/AIDS in Public Health Teaching.

Objectives: To collate the experiences of involvement of people living with HIV/AIDS (PLWHA) in academic public health teaching to inform future public health education models involving people affected by long-term effects of other pandemics. Our goal is to describe interventions in a way that makes them accessible to potential public health teachers hoping to adapt patient involvement paradigms in their teaching of chronic illness brought on by infectious diseases. Methods: Narrative review based on a literature search in PubMed and Google Scholar up to September 2021. Fifteen articles that contained a description of a health educational intervention on HIV/AIDS that actively involved PLWHA were included. Results: Interventions either involved PLWHA as teachers and program/curriculum developers or incorporated experiential elements in which students have genuine contact with PLWHA. Creating safe spaces, recognizing PLWHA as experts, relating to each other differently were common transformative elements. Conclusion: Involving PLWHA in public health teaching have transformative and empowering outcomes, both for PLWHA and for learners. This finding should inform new teaching programs that will address the long-term effects of other pandemics such as COVID-19.

‘Down to the person, the individual patient themselves’: A qualitative study of treatment decision‐making for shoulder pain

IntroductionMany inconsistencies have been identified in the translation of evidence‐based treatment recommendations for musculoskeletal shoulder pain into healthcare services, with little known about factors influencing decision‐making. The objective of this study was to explore the views and experiences of healthcare providers (HCPs) and people living with shoulder pain on treatment decision‐making.MethodsAdopting a qualitative design, purposeful sampling was employed to recruit 13 individuals with nonspecific musculoskeletal shoulder pain and 30 HCPs. Data were collected through 1:1 semi‐structured interviews and analysed using an approach informed by Constructivist Grounded Theory. To facilitate analysis, two patient and public involvement (PPI) meetings were conducted.ResultsMost participants (69%) had shoulder pain of ≥1‐year duration. Biomechanical beliefs about shoulder pain predominated and were heavily influential in decision‐making for both patients and HCPs. Despite a consensus that therapeutic alliance facilitated decision‐making, the extent of collaboration between HCPs and patients in treatment decision‐making was rather limited. In addition to condition‐specific factors, Individual patient characteristics and resources also influenced treatment decisions.ConclusionFindings revealed the complexity of the decision‐making process for both patients and HCPs, exposing substantial gaps between the reported views and experiences of participants and the principles of client‐centred and evidence‐based practice. There is a pressing need to enhance the translation of evidence‐based knowledge into practice in this clinical area.Patient or Public ContributionIn line with a consultative approach to collaborative data analysis, a subgroup of participants attended two PPI meetings to provide commentary and feedback on preliminary findings.

The Effects of Shared Decision-Making on Patient Participation in Discharge Meetings in a Behavioral Health Unit.

BACKGROUND: Research suggests that persons diagnosed with behavioral health illnesses can benefit from shared decision-making. On an inpatient behavioral health unit, low Press Ganey scores related to satisfaction with involvement in care triggered a root cause analysis that identified patients did not feel engaged by nursing during their time together; and discharge meetings with the health care team were not required. AIMS: The purpose of this quality improvement project was to improve patient perception of involvement in their care as evidenced by increased Press Ganey scores and increased number of patients involved in discharge meetings. METHODS: Nurses used an evidence-based model for nurse-patient communication: the Seeking information, Engaging in conversation, Exploring options, and Deciding on treatment (SEED) and use of a Control Preferences Scale (CPS) to increase communication about treatment and discharge decisions. RESULTS: A total of 120 patients engaged in the intervention. Patient presence at discharge meetings increased from 39% to 82% (p < .001), and Press Ganey scores evidenced minimal change. CONCLUSIONS: Use of the SEED model and CPS by nurses was effective in increasing patients' involvement in their treatment. Although findings were limited due to COVID-19, the study suggests that improving patient involvement from admission through discharge throughout hospitalization can improve patient experience scores.

Where National Medicines Policies Have Taken Us With Patient Involvement and Health Technology Assessment in Africa.

The Covid-19 pandemic has highlighted global knowledge about, but lack of equitable access to, life-changing medicines, and other innovative medical products by populations in African low and middle income countries. The World Health Organization (WHO) and other international non-profit foundations and organizations are constantly striving to address inequity. In the 1970s, WHO initiated a regularly updated essential medicines list, together with the concept of national medicines policies (NMPs) to ensure access and availability, affordability, rational, and effective use of medicines which are considered essential in addressing predominant population health issues and disease burden. We studied the NMPs of Ghana, South Africa, Uganda and Zimbabwe to highlight some of the important issues that these countries experience in the safe and effective use of medical products. Thailand is an example of how health technology assessment (HTA) can provide a country with an internationally supported, clearly defined and transparent process to broaden access to medicines and services. These medical services can add considerable value in accordance with local values and priorities. Involvement of civil society adds democratic legitimacy to such processes. Community health workers and patient advocacy groups are important in raising awareness and knowledge of safety issues and the effective use of quality medicines. They can apply pressure for increased funding to improve access to healthcare. Medicines and services that contribute to supported self-care are of benefit in any setting. Joint efforts across African countries such as with the African Medicines Agency are important in addressing some of the major health issues.

Patient Involvement in the Health Technology Assessment Process in Taiwan.

The COVID-19 pandemic initially had a smaller impact on Taiwan than on most other industrialized countries. However, an outbreak in late April 2021 led to a sharp surge in cases from mid-May 2021. Patient involvement in the health technology assessment (HTA) process, however, was not much affected by this; virtual meetings were implemented. This descriptive paper presents an overview of patient involvement in the HTA process in Taiwan via the National Health Insurance Administration (NHIA) online submission platform, participation in appraisal committees, education programs, and cooperation with patients' organizations, and outlines its progress and challenges. The National Health Insurance Act, amended in 2013, protects patients' rights and invites them to voice their opinions, which are then presented to the relevant authority. Based on this act, various mechanisms have been developed to involve patients, caregivers, and patient organizations in both the HTA and the reimbursement process. Prior to the Pharmaceutical Benefit and Reimbursement Scheme (PBRS) Joint Committee meeting, the NHIA built an online platform that allows patients to submit their opinions, which are then incorporated into the HTA reports. The results are also discussed with patient representatives, following which the related documents are published on the NHIA website. From May 2015 to December 2020, 30 patients' insights were published before the PBRS Joint Committee meetings. Of these, 19 (63%) were related to oncology cases. In Taiwan, approaches to fostering patient engagement include the use of a platform for patients' and patients groups' input, among others. Although patient engagement is important for understanding the needs of the target patient population, challenges in ensuring timely patient engagement and provision of relevant resources remain. In addition, further efforts are needed to implement and improve the visibility of patient input in the HTA process.

Development and evaluation of rapid data-enabled access to routine clinical information to enhance early recruitment to the national clinical platform trial of COVID-19 community treatments.

BACKGROUND: The COVID-19 pandemic has presented unique challenges for rapidly designing, initiating, and delivering therapeutic clinical trials. PRINCIPLE (Platform Randomised Trial of Treatments in the Community for Epidemic and Pandemic Illnesses) is the UK national platform investigating repurposed therapies for COVID-19 treatment of older people in the community at high risk of complications. Standard methods of patient recruitment were failing to meet the required pace and scale of enrolment. This paper describes the development and appraisal of a near real-time, data-driven, ethical approach for enhancing recruitment in community care by contacting people with a recent COVID-19 positive test result from the central NHS Test and Trace service within approximately 24-48 h of their test result. METHODS: A multi-disciplinary team was formed to solve the technical, ethical, public perception, logistical and information governance issues required to provide a near-real time (approximately within 24-48 h of receiving a positive test) feed of potential trial participants from test result data to the research team. PRINCIPLE was also given unique access to the Summary Care Record (SCR) to ensure safe prescribing, and to enable the trial team to quickly and safely bring consented patients into the trial. A survey of the public was used to understand public perceptions of the use of test data for this proposed methodology. RESULTS: Prior to establishing the data service, PRINCIPLE registered on average 87 participants per week. This increased by up to 87 additional people registered per week from the test data, contributing to an increase from 1013 recruits to PRINCIPLE at the start of October 2020 to 2802 recruits by 20 December 2020. Whilst procedural caveats were identified by the public consultation, out of 2639 people contacted by PRINCIPLE following a positive test result, no one raised a concern about being approached. CONCLUSIONS: This paper describes a novel approach to using near-real time NHS operational data to recruit community-based patients within a few days of presentation with acute illness. This approach increased recruitment and reduced time between positive test and randomisation, allowing more rapid evaluation of treatments and increased safety for participants. End-to-end public and patient involvement in the design of the approach provided evidence to inform information governance decisions. TRIAL REGISTRATION: PRINCIPLE is funded by UK Research and Innovation and the Department of Health and Social Care through the National Institute for Health Research. EudraCT number: 2020-001209-22 . 26/03/2020 ISRCTN registry: ISRCTN86534580 . 20/03/2020 REC number: 20/SC/058 IRAS number: 281958.

Patients' perspective on supposedly patient-relevant process and outcome parameters: a cross-sectional survey within the 'PRO patients study'.

BACKGROUND: To be able to make informed choices based on their individual preferences, patients need to be adequately informed about treatment options and their potential outcomes. This implies that studies measure the effects of care based on parameters that are relevant to patients. In a previous scoping review, we found a wide variety of supposedly patient-relevant parameters that equally addressed processes and outcomes of care. We were unable to identify a consistent understanding of patient relevance and therefore aimed to develop an empirically based concept including a generic set of patient-relevant parameters. As a first step we evaluated the process and outcome parameters identified in the scoping review from the patients' perspective. METHODS: We conducted a cross-sectional survey among German general practice patients. Ten research practices of Witten/Herdecke University supported the study. During a two-week period in the fall of 2020, patients willing to participate self-administered a short questionnaire. It evaluated the relevance of the 32 parameters identified in the scoping review on a 5-point Likert scale and offered a free-text field for additional parameters. These free-text answers were inductively categorized by two researchers. Quantitative data were analyzed using descriptive statistics. Bivariate analyses were performed to determine whether there are any correlations between rating a parameter as highly relevant and patients' characteristics. RESULTS: Data from 299 patients were eligible for analysis. All outcomes except 'sexuality' and 'frequency of healthcare service utilization' were rated important. 'Confidence in therapy' was rated most important, followed by 'prevention of comorbidity' and 'mobility'. Relevance ratings of five parameters were associated with patients' age and gender, but not with their chronic status. The free-text analysis revealed 15 additional parameters, 12 of which addressed processes of care, i.e., 'enough time in physician consultation'. CONCLUSION: Patients attach great value to parameters addressing processes of care. It appears as though the way in which patients experience the care process is not less relevant than what comes of it. Relevance ratings were not associated with chronic status, but few parameters were gender- and age-related. TRIAL REGISTRATION: Core Outcome Measures in Effectiveness Trials Initiative, registration number: 1685.

The impact of COVID-19 on patient engagement in the health system: Results from a Pan-Canadian survey of patient, family and caregiver partners.

INTRODUCTION: The COVID-19 pandemic has had an impact on all aspects of the health system. Little is known about how the activities and experiences of patient, family and caregiver partners, as a large group across a variety of settings within the health system, changed due to the substantial health system shifts catalysed by the pandemic. This paper reports on the results of a survey that included questions about this topic. METHODS: Canadian patient, family and caregiver partners were invited to participate in an online anonymous survey in the Fall of 2020. A virtual snowballing approach to recruitment was used. Survey invitations were shared on social media and emailed to health system and governmental organizations with the request that they share the survey with patient partners. This paper focuses on responses to two questions related to patient partner experiences during the COVID-19 pandemic. RESULTS: The COVID-19 questions were completed by 533 respondents. Over three quarters of respondents (77.9%, n = 415) indicated their patient engagement activities had been impacted by COVID-19. The majority (62.5%, n = 230) experienced at least a temporary or partial reduction in their patient engagement activities. Some respondents did see increases in their patient engagement activities (11.4%, n = 42). Many respondents provided insights into their experience with virtual platforms for engagement (n = 194), most expressed negative or mixed experiences with this shift. CONCLUSIONS: This study provides a snapshot of Canadian patient, family and caregiver partners' perspectives on the impact of COVID-19 on their engagement activities. Understanding how engagement unfolded during a crisis is critical for our future planning if patient engagement is to be fully integrated into the health system. Identifying how patient partners were engaged and not engaged during this time period, as well as the benefits and challenges of virtual engagement opportunities, offers instructive lessons for sustaining patient engagement, including the supports needed to engage with a more diverse set of patient, family and caregiver partners. PATIENT CONTRIBUTION: Patient partners were important members of the Canadian Patient Partner Study research team. They were engaged from the outset, participating in all stages of the research project. Additional patient partners were engaged to develop and pilot test the survey, and all survey respondents were patient, family or caregiver partners. The manuscript is coauthored by two patient partners.

Experiences of patients advising on mental health research: qualitative study in South-East European countries

BackgroundAlthough patient and carer involvement in research is well-developed in many countries, this area has been largely overlooked in South-East European countries.AimsTo explore experiences of patients participating in newly set up lived experience advisory panels (LEAPs) within a European Commission funded, large-scale, multi-country mental health research project that focused on improving treatment of individuals with psychosis.MethodTwenty-one mental health patients were individually interviewed across five countries: Bosnia and Herzegovina, Kosovo, Montenegro, North Macedonia and Serbia. Topic guides covered the experience of participating in LEAPs and their sustainability. Data were analysed by framework analysis.ResultsSeven themes were identified about participating in LEAPs: predominantly positive evaluation, high levels of participant motivation, therapeutic benefits for participants, few challenges, various future perspectives, positive appraisal of the research project and mixed reflections on mental healthcare. Overall, patients’ experiences were positive and enabled them to feel empowered. Patients expressed interest in remaining involved in advisory panels. Additionally, they felt that they could potentially contribute to the work of non-government organisations.ConclusionsThis study is among the few studies exploring patient participation in research projects, and the first such study conducted in South-East European countries. Patients are highly motivated for this engagement, which has the potential to empower them to take on new social roles. Significant efforts at the national level are needed in each country, to make patient involvement in research standard practice.