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Cntroduction 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., 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.

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.

Background: Autonomy-supporting interventions, such as self-determination theory and guided self-determination interventions, may improve self-management and clinical and psychosocial outcomes in people with diabetes. Such interventions have never been systematically reviewed assessing both benefits and harms and concurrently controlling the risks of random errors using trial sequential analysis methodology. This systematic review investigates the benefits and harms of self-determination theory-based interventions compared to usual care in people with diabetes. Methods: We used the Cochrane methodology. Randomized clinical trials assessing interventions theoretically based on guided self-determination or self-determination theory in any setting were eligible. A comprehensive search (latest search April 2022) was undertaken in CENTRAL, MEDLINE, Embase, LILACS, PsycINFO, SCI-EXPANDED, CINAHL, SSCI, CPCI-S, and CPCI-SSH to identify relevant trials. Two authors independently screened, extracted data, and performed risk-of-bias assessment of included trials using the Cochrane risk-of-bias tool 1.0. Our primary outcomes were quality of life, all-cause mortality, and serious adverse events. Our secondary outcomes were diabetes distress, depressive symptoms, and nonserious adverse events not considered serious. Exploratory outcomes were glycated hemoglobin and motivation (autonomy, controlled, amotivation). Outcomes were assessed at the end of the intervention (primary time point) and at maximum follow-up. The analyses were conducted using Review Manager 5.4 and Trial Sequential Analysis 0.9.5.10. Certainty of the evidence was assessed by GRADE. Results: Our search identified 5578 potentially eligible studies of which 11 randomized trials (6059 participants) were included. All trials were assessed at overall high risk of bias. We found no effect of self-determination theory-based interventions compared with usual care on quality of life (mean difference 0.00 points, 95%

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, 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

Purpose The objective of this systematic review was to establish an overview of aromatase inhibitor–related symptoms reported by postmenopausal women with nonmetastatic, estrogen receptor–positive breast cancer. Data Sources Eight databases (PubMed, Cochrane, Cumulative Index to Nursing and Allied Health Literature [CINAHL], Ovid EMBASE, Ovid MEDLINE, PsycINFO, Scopus, and Web of Science) were searched for trials published between January 2004 and November 2021. Inclusion criteria were studies exploring patient-reported aromatase inhibitor–related symptoms in postmenopausal women with nonmetastatic estrogen receptor–positive breast cancer. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and the Mixed Method Appraisal Tool were used to rate the quality of the trials included. Of 325 full-text papers, 10 were included. Patient-reported symptoms were clustered by using the European Organization for Research and Treatment of Cancer Quality of Life C30 questionnaire domains. Additional domains were used to cluster other symptoms mentioned: menopausal, sex-related, body alteration, and eye-related. The following clusters were the most frequently presented: sex-related (14 symptoms), pain (9 symptoms), insomnia (5 symptoms), and menopausal (5 symptoms). Conclusion The target group reported a variety of symptoms related to aromatase inhibitors. No tools are currently available to measure all the symptoms reported, indicating a need to revise the tools to acknowledge additional symptoms. Prospective studies are needed to investigate the prevalence of aromatase inhibitor–related symptoms in women with breast cancer., Purpose: The objective of this systematic review was to establish an overview of aromatase inhibitor–related symptoms reported by postmenopausal women with nonmetastatic, estrogen receptor–positive breast cancer. Data Sources: Eight databases (PubMed, Cochrane, Cumulative Index to Nursing and Allied Health Literature [CINAHL], Ovid EMBASE, Ovid MEDLINE, PsycINFO, Scopus, and Web of Science) were searched for trials published between January 2004 and November 2021. Inclusion criteria were studies exploring patient-reported aromatase inhibitor–related symptoms in postmenopausal women with nonmetastatic estrogen receptor–positive breast cancer. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and the Mixed Method Appraisal Tool were used to rate the quality of the trials included. Of 325 full-text papers, 10 were included. Patient-reported symptoms were clustered by using the European Organization for Research and Treatment of Cancer Quality of Life C30 questionnaire domains. Additional domains were used to cluster other symptoms mentioned: menopausal, sex-related, body alteration, and eye-related. The following clusters were the most frequently presented: sex-related (14 symptoms), pain (9 symptoms), insomnia (5 symptoms), and menopausal (5 symptoms). Conclusion: The target group reported a variety of symptoms related to aromatase inhibitors. No tools are currently available to measure all the symptoms reported, indicating a need to revise the tools to acknowledge additional symptoms. Prospective studies are needed to investigate the prevalence of aromatase inhibitor–related symptoms in women with breast cancer. Implication for Nursing Practice: Identification of patient-reported clinically relevant symptoms can enable targeted symptom assessment and management strategies for women with breast cancer undergoing aromatase inhibitor treatment.

Women with breast cancer are a growing population due to improved screening and treatment. It has been described that chemotherapy can negatively affect patients’ metabolism. The aim of this study is to assess weight gain during chemotherapy treatment in an interim analysis on an ongoing prospective cohort of women with early breast cancer. To help untangle the many possible reasons for weight change, we examine blood tests, Patient-Reported Outcomes (PROs), and bone mineral density (BMD). We find that the 38 women that have measurements taken after chemotherapy have an average weight gain of 1.2 kg although not significant. Together with this, there is a significant drop in HDL cholesterol, an increase in triglycerides, and a non-significant tendency towards decreased insulin sensitivity. PROs show that although the women experience more pain and fatigue, they have higher activity levels. BMD is at an expected level according to age. All in all, we see an increased focus on physical activity and nutrition, leading to less severe metabolic changes as previously reported. However, even though more measures are taken, we still see an overall negative metabolic impact with unknown long-term implications.

Background (and Purpose): The aim of this study was to investigate the importance of including the measurement of bone mineral density (BMD) in reliable fracture risk assessment for women diagnosed with early nonmetastatic breast cancer (EBC) before AI treatment if zoledronic acid is not an option. Material and Methods: One hundred and sixteen women with EBC were included in the study before initiating AI treatment. Most participants were osteopenic. The 10-year probability of hip fracture and major osteoporotic fracture was calculated with and without BMD based on clinical information collected at baseline using the fracture risk assessment (FRAX) tool. To compare data, the nonparametric tests were used. Results: There was a signifcant diference (p<0.001) in the number of high-risk and low-risk FRAX score of hip fracture between before and after including BMD values. The high-risk category decreased by 50.9%, while the low-risk category increased by 42.9%. In FRAX score of major osteoporotic the findings were similar (p<0.001): The high-risk and moderate-risk category decreased by 70.4% and 4.9%, respectively, while the low-risk category increased by 43.8% when including BMD value. When stratifed by age, patients aged 65 years or older were at a signifcantly (p<0.001) higher risk of suffering a hip or major osteoporotic fracture, highlighting the importance of including BMD measurements in this age group. Conclusions: Our data support that DXA scanning of women with EBC should be performed to avoid overestimation of osteoporosis before AI treatment. It is particularly important in patients older than 65 years of age and when zoledronic acid is not an option.