Patient-reported outcomes used actively in cancer patients undergoing antineoplastic treatment: A mini-review of the Danish landscape.

Introduction: Many studies using Patient-reported outcomes (PRO) data have been conducted to monitor symptoms and health-related quality of life during follow-up after cancer treatment. However new ways of using (e)PROs have emerged. We aimed to explore the Danish landscape of the use of PRO in a research setting, where PRO is used actively in cancer patients undergoing treatment, and give an overview of how it is embraced by patients and clinicians. Methods and materials: A literature search was performed in June 2023, using the keywords Denmark, cancer, and patient-reported outcomes. An expert on literature searches identified the search terms, and double screening was performed at both abstract and screening levels and full-text stage. The software tool Covidence was used. Results: 467 articles were retrieved and 19 studies were included. They described the type of ePRO instrument used and the application of active ePRO i.e. a dialogue tool in the clinical encounter, release of alerts to clinicians, and enhancement of self-management. Finally, a development in the use of active ePROs over time is elucidated and we show how it is embraced by patients and clinicians. Conclusion: This mini-review gives an overview of how ePRO solutions are tested in oncological research in Denmark and embraced by patients and clinicians. ePRO solutions in a Danish setting seem well-suited for self-management. However, if more impact is warranted, clinicians need to engage in reviewing and using ePROs. Moreover, for successful implementation, the integration of ePROs in electronic health records must be supported by IT specialists and management.

Patient Engagement in Research Scale (PEIRS-22): Danish translation, applicability, and user experiences.

BACKGROUND: Patient and Public Involvement (PPI) in health research is gaining increased attention and acceptance worldwide. Reliable measurements are crucial to accurately assess, monitor, and evaluate patient involvement efforts in research. The Patient Engagement in Research Scale (PEIRS-22) measures meaningful patient and family caregiver engagement in research. This study focuses on three primary objectives: (1) translation of the PEIRS-22 from English to Danish, followed by linguistic validation and cultural adaptation; (2) assessing the applicability of the Danish PEIRS-22; and (3) focus group interviews to explore the user experiences of PPI. METHODS: A three-phase multi-method study was conducted. In phase one, the PEIRS-22 was translated, linguistically validated and culturally adapted to Danish. In phase two individuals from three distinct patient cancer advisory boards responded to the Danish version of PEIRS-22 to assess its applicability. Three focus group interviews were conducted in phase three, involving individuals from three patient cancer advisory boards. RESULTS: The translation process resulted in a Danish version of PEIRS-22, conceptually and culturally equivalent to the English version. Overall, among individuals of the three advisory boards (n = 15) the applicability was found to be satisfactory, with no missing data and all items completed. The total PEIRS-22 score among the three advisory boards was 85.2 out of a possible 100, with higher scores indicating greater meaningful involvement. A nested sample of the three patient cancer advisory boards (n = 9) participated in focus group interviews. The analysis yielded four themes: (1) The Danish PEIRS-22 captured the intended cultural meaning and contributed to self-reflection, (2) Internal motivation is a driver for involvement (3), Involvement brought a personal sense of empowerment and (4) Meaningful involvement collaborations are fostered by a trustful atmosphere. CONCLUSIONS: The PEIRS-22 questionnaire has been translated, linguistically validated, and culturally adapted into Danish. We propose that the PEIRS-22 is now ready for use in Danish populations. This study provides a Danish version of the questionnaire that can be used to develop patient-centred practices and foster meaningful involvement and collaborations between patients and researchers in the field of cancer research in Denmark. Personal benefits of participating in PPI can vary, and we recommend using PEIRS-22 in conjunction with a qualitative approach to better explore perspectives on meaningful involvement. TRIAL REGISTRATION: The study was registered prospectively on October 22, 2022, by the Danish Data Protection Agency (jr. nr. P-2022-528).

Patient and public involvement (PPI) in research can improve research practices by ensuring that patients' voices are heard. Individuals' lived experiences and unique viewpoints can contribute to refining research aims, ensuring they align with the needs and priorities of the target population. There is a growing interest in inviting patients into the research team as patient partners, for example, by establishing patient advisory boards. PPI can also involve caregivers and other stakeholders who are not usually thought of as members of the research team. For that reason, broadening our understanding of establishing meaningful PPI starts with measuring patient and family caregiver involvement. As such, the Patient Engagement In Research Scale (PEIRS-22) has been developed in the English language to measure meaningful patient and caregiver involvement. In this study, we aimed to (1) create a Danish version of the PEIRS-22 that respects any unique feature of Danish people, (2) assess the applicability of the Danish PEIRS-22, and (3) via focus-group interviews explore the user experiences of PPI. The patients and caregiver who were interviewed as part of the translation process expressed that the PEIRS-22 was easy to understand and captured the intended meanings. Fifteen other patient partners responded to the Danish version of PEIRS-22, and nine of them participated in the focus group interviews. One result was that creating a trusting and social atmosphere within the research group is important for promoting a personal sense of involvement.

Patient and public involvement in Nordic healthcare research: a scoping review of contemporary practice.

BACKGROUND: Over the past decades, there has been a growing international interest in user involvement in healthcare research. However, evidence on the management and impact of patient and public involvement in Nordic healthcare research remains limited. OBJECTIVE: The aim was to explore and delineate the current state, practice, and impact of patient and public involvement in healthcare research across different areas of healthcare and patient populations in the Nordic countries. METHODS: We conducted a scoping review using nine scientific databases and gray literature from 1992-2023. Sources were categorized as empirical or non-empirical. We used the Guidance for Reporting Involvement of Patients and the Public Short Form 2 checklist for reporting of patient and public involvement in healthcare research and the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. RESULTS: A total of 56 publications were included, consisting of 39 empirical and 17 non-empirical sources. Gray literature varied among countries and institutions encompassing different types of documents. We found an increase in the number of publications on patient and public involvement in Nordic healthcare research. This was evidenced by the growing number of references and institutional initiatives intended at involving the public, indicating the increasing emphasis on patient and public involvement in Nordic healthcare research. The terminology used to describe patient and public involvement varied over time. However, there has been a gradual narrowing down of terms as the concept of PPI has become more integrated into research practices, particularly with the involvement of funding agencies. CONCLUSION: The utilization of patient and public involvement in Nordic healthcare research has substantially increased, proliferated, and gained widespread acceptance across diverse healthcare domains. The variety of approaches challenged our scoping review in terms of systematic description and impact. Patient and public involvement was applied in one or more research stages using different methodologies and terms. International agreement on terms and definitions is needed for reliable interpretation of the use of patient and public involvement in Nordic healthcare research.

Over the past decades the importance of involving patients and the public as active partners in healthcare research has received growing acknowledgement internationally. Nonetheless, our knowledge regarding the degree of patient and public involvement (PPI) in the Nordic countries remains limited. This paper addresses this gap by investigating the status, management, and influence of PPI in healthcare research within the Nordic countries. The review of these aspects has given us a better understanding of PPI and its effects on healthcare research in the Nordic region. We looked at scientific databases and webpages including research papers, commentaries, and other materials from Denmark, Norway, Sweden, Finland, and Iceland. Our goal was to gather information and provide a thorough overview of PPI practices. Our findings showed that PPI is growing with gained acceptance across different areas of health research. PPI was used at different stages of the research process, but there wasn't a common agreement on its importance and the additional value it brings to the quality of research. The study was challenged by the many different terms and definitions, which affected the clarity of our study's purpose (or goals).However, we made efforts to address this by carefully reviewing the different terms and definitions used in the literature, striving to capture the essence of PPI in our analysis. By acknowledging this variation, we aimed to provide a wide-ranging overview while identifying the complexities and nuances related with PPI in the Nordic healthcare research. We assume that achieving international agreement on terms and definitions of PPI would certainly improve the trustworthiness in future reviews.

A multi-method approach to selecting PRO-CTCAE symptoms for patient-reported outcome in women with endometrial or ovarian cancer undergoing chemotherapy.

BACKGROUND: Women with endometrial or ovarian cancer experience a variety of symptoms during chemotherapy. Patient-Reported outcomes (PROs) can provide insight into the symptoms they experience. A PRO tool tailored to this patient population can help accurately monitor adverse events and manage symptoms. The objective of this study was to identify items in the National Cancer Institute's measurement system Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) appropriate for use in a PRO tool for a population of women with endometrial or ovarian cancer undergoing treatment with taxanes (paclitaxel or docetaxel) in combination with carboplatin. METHODS: A two-phase, sequential multi-methods approach was applied. In phase one, a comprehensive literature search was done to map the toxicity of the applied chemotherapeutics and phase III clinical studies. Phase two, which comprised selecting the PRO-CTCAE items, included discussions with and feedback from a patient advisory board, an additional literature search, and focus group interviews with senior oncologists and specialized oncology nurses. A national expert panel facilitated both phases in terms of carefully select items from the PRO-CTCAE library. RESULTS: Phase one identified 18 symptoms and phase two, three additional ones, leading to the inclusion of 21 PRO-CTCAE symptoms in the final PRO tool. Since PRO-CTCAE also contains one to three sub-questions on the frequency, severity, and interference with daily activities of symptoms, there were 44 potential items. CONCLUSIONS: This study describes taking a multi-method approach to selecting items from the PRO-CTCAE library for use in a population of women with endometrial or ovarian cancer undergoing chemotherapy. By systematically combining diverse approaches, we carefully selected 21 clinically relevant symptoms covered by 44 items in the PRO-CTCAE library. Future studies should investigate the psychometric properties of this PRO tool for women with endometrial or ovarian cancer.

Danish translation and linguistic validation of a self-efficacy questionnaire.

INTRODUCTION: The Self-Efficacy for Managing Chronic Disease 6-item Scale is a widely used questionnaire instrument for measuring self-efficacy. Since self-efficacy has increasingly been recognised as an essential prerequisite for effective self-management of chronic diseases, valid and reliable measures are needed to do evaluations in research and clinical practice. This study aimed to translate and perform linguistic validation of the questionnaire for use in a Danish population and context. METHODS: The translation and validation process, which followed the International Society for Pharmacoeconomics and Outcome Research guidelines, included professional translation and back translation, facilitated by clinical experts. Furthermore, we conducted cognitive debriefing interviews with patients diagnosed with chronic diseases. RESULTS: The questionnaire was translated into Danish and linguistically validated, each step producing changes leading to a more conceptually and culturally equivalent Danish version. The back translation was compared with the original English version which led to the identification of discrepancies requiring discussion before the next back translation. Ten participants were recruited for the cognitive debriefing interviews and contributed to minor changes. CONCLUSION: The Danish version of the Self-Efficacy for Managing Chronic Disease 6-item Scale is ready for use among Danish-speaking patients with chronic diseases. FUNDING: This work was supported by the Models of Cancer Care Research Program with grants from the Novo Nordisk Foundation (NNF16OC0022338) and Minister Erna Hamilton's Grant for Science and Art, (06-2019). The funding source did not contribute to the study. TRIAL REGISTRATION: not relevant.

The Symptom Experience and Self-management Strategies of Women Undergoing Cervical Cancer Treatment: A Qualitative Study.

BACKGROUND: Cervical cancer treatment modalities, such as surgery, chemotherapy, radiation, and brachytherapy, often result in short- and long-term adverse effects such as nausea, fatigue, and sexual dysfunction. Chemotherapy and radiation are typically provided on an outpatient basis, requiring women to be more active in self-managing their symptoms at home. OBJECTIVE: The aim of this study was to explore how women with cervical cancer experience symptoms and manage daily life during treatment. METHODS: Individual interviews with 10 women diagnosed with cervical cancer and undergoing curative concurrent chemotherapy and radiation were carried out. Data analysis was conducted using a phenomenological-hermeneutic perspective, inspired by Ricoeur. RESULTS: Three themes were identified based on the interviews: (1) new life perspectives, (2) suffering in silence, and (3) enhanced symptom self-management strategies. CONCLUSION: Diagnosis and treatment create an opportunity for the women to critically reflect on their lives and to develop new life perspectives. During treatment, a mental transformation involving the use of various individual social, mental, and physical coping strategies allowed the women to manage their daily lives. This enabled self-management strategies, resulting in maintaining a sense of normalcy, trying to defy the adverse effects, and prioritizing themselves, their families, and the treatment. IMPLICATIONS FOR PRACTICE: Women with cervical cancer undergoing oncological treatment need more specific and detailed information about the course of treatment, symptom management, adverse effects, and psychological reactions to better manage their daily lives. Healthcare professionals play a crucial role in supporting and guiding the women and in ensuring optimal symptom management.

Patient perspectives and experiences of the rapid implementation of digital consultations during COVID-19 - a qualitative study among women with gynecological cancer.

PURPOSE: Due to the first COVID-19 outbreak and subsequent restrictions, standard practice for gynecological cancer quickly evolved to include additional digital consultations. Women with gynecological cancer have a high need for information and experience a high symptom burden. We aimed to explore the experiences and perspectives of the rapid implementation of digital consultations during COVID-19. METHODS: We conducted individual telephone interviews with patients with gynecological cancer 1-4 days after a telephone or video consultation during the COVID-19 outbreak in April and May 2020. We applied Braun and Clarke's thematic analysis to analyze the qualitative data. RESULTS: Thirty-two patients with ovarian (50%), cervical (35%), vulvar (12%), and vaginal cancer (3%) participated in the study. The patients experienced that, combined, cancer and COVID-19 restrictions made their situation twice as challenging. In general, the patients valued face-to-face consultations, recommending that they were ideal for the initial appointment to build trust. Overall, there was a willingness to participate in digital consultations because of the restrictions, but the results also showed varying degrees of openness and that individual solutions were favored. CONCLUSION: The findings of this study show that digital consultations were an accepted alternative during COVID-19. Even though this temporary solution was deemed to be beneficial for practical reasons, patients also experienced digital consultations to be impersonal. A key message is that face-to-face encounters create the foundation to establish a trusting relationship from where a valuable dialogue arises. Digital consultations should therefore be implemented with caution since no one-size-fits-all model is recommended. Among patients with gynecological cancer, however, digital technologies represent a promising and flexible method depending on the purpose of consultations, patient preferences, and needs.