Allergic Sensitization and Psychosomatic Involvement in Outdoor and Indoor Workers: A Preliminary and Explorative Survey of Motorway Toll Collectors and Office Employees.

The incidence of respiratory and cutaneous allergic disorders may be variable if we consider work activity. These disorders are reported in the current literature to have a relevant psychosomatic involvement. The aim of the study was to submit a survey on the self-reported occurrence of allergic respiratory and cutaneous diseases in outdoor and indoor workers to verify the onset or exacerbations of such pathologies, encourage surveillance, and suggest the need for further studies. Two groups of workers were compared when exposed and not exposed to air pollutants. An outdoor population of motorway toll collectors (153 workers; M: 58.03 years old, SD: 6.1; and female prevalence of 66.01%) and an indoor group of office employees (59 workers; mean age 54.44 years, SD: 8.50; and male prevalence of 61.02%) entered the study. The results of three multivariate analyses of the obtained data, investigating contributions of external factors, including age, sex, smoking habits, working type, and seniority, on allergic conditions were significant in both workers' groups. The findings highlighted that age and smoking habits were significant contributors to allergic conditions, both independently and in combination with other factors, such as sex and working type. The data suggest the presence of phenomena related to different etiological domains, as already reported in the literature. Through the collection of these data, it was possible to highlight the need to analyze clinical signs from different perspectives.

Development of an App for Symptom Management in Women With Breast Cancer Receiving Maintenance Aromatase Inhibitors: Protocol for a Mixed Methods Feasibility Study.

BACKGROUND: Patients with postmenopausal nonmetastatic estrogen receptor-positive breast cancer often experience a reduced quality of life after primary treatment. The disease and treatment trajectory consists of surgery followed by chemotherapy or radiation therapy. Upon this, maintenance hormone therapy with an aromatase inhibitor can result in several physical and psychosocial symptoms. Optimal symptom control during maintenance therapy is central to maintaining the patient's quality of life. OBJECTIVE: This study aims to (1) develop an electronic symptom management tool for patients with postmenopausal early breast cancer receiving maintenance aromatase inhibitors with an endocrine aspect and (2) assess the feasibility, acceptability, and usability of the pilot version of the Bone@BC app. Furthermore, longitudinally, symptom prevalence and quality of life for patients with postmenopausal nonmetastatic estrogen receptor-positive breast cancer will be explored. METHODS: This study follows a multistage research plan. In stage 1, a systematic literature review to establish an overview of aromatase inhibitor-related symptoms reported by postmenopausal women with nonmetastatic estrogen receptor-positive breast cancer will be completed. In stage 2, a comprehensive overview of symptoms related to aromatase inhibitors (letrozole, exemestane, and anastrozole) will be performed (eg, by reviewing medical leaflets and guidelines). In stage 3, an electronic app with a user-friendly Patient Concern Inventory list to comprise symptoms and concerns will be developed. Last, in stage 4, a convergent mixed methods feasibility study of the pilot version of the Bone@BC app will be conducted. A total of 45 patients with postmenopausal nonmetastatic estrogen receptor-positive breast cancer will use the app daily for symptom identification and respond to 6 serial patient-reported outcome measurements for 12 weeks. Finally, semistructured interviews will be performed. The primary outcome includes consent rate, attrition rate, retention rates, technical issues, and adherence, assessed using preestablished criteria on feasibility and a mixed methods approach for exploring acceptability. A patient advisory board consisting of 5 women with breast cancer is recruited to include their perspectives and experiences in the planning, organization, implementation, and dissemination of the research throughout the project. RESULTS: At the time of submitting this paper (January 2024), a total of 23 patients have been included in the stage 2 medical audit over the recruitment period of 3 months (November 2022 to February 2023), and 19 patients have been enrolled in stage 2, the semistructured patient interviews. CONCLUSIONS: This protocol describes a study investigating the feasibility, acceptability, and usability of the symptom management tool Bone@BC developed for patients with breast cancer with an endocrine aspect. TRIAL REGISTRATION: ClinicalTrails.gov NCT05367830; https://clinicaltrials.gov/ct2/show/NCT05367830. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/49549.

Prediction of pain using electrocardiographic-derived autonomic measures: A systematic review.

BACKGROUND AND OBJECTIVE: Pain is a major clinical challenge, and understanding the pathophysiology is critical for optimal management. The autonomic nervous system reacts to pain stimuli, and autonomic dysfunction may predict pain sensation. The most used assessment of autonomic function is based on electrocardiographic measures, and the ability of such measures to predict pain was investigated. DATABASES AND DATA TREATMENT: English articles indexed in PubMed and EMBASE were reviewed for eligibility and included when they reported electrocardiographic-derived measures' ability to predict pain response. The quality in prognostic studies (QUIPS) tool was used to assess the quality of the included articles. RESULTS: The search revealed 15 publications, five on experimental pain, five on postoperative pain, and five on longitudinal clinical pain changes, investigating a total of 1069 patients. All studies used electrocardiographically derived parameters to predict pain assessed with pain thresholds using quantitative sensory testing or different scales. Across all study modalities, electrocardiographic measures were able to predict pain. Higher parasympathetic activity predicted decreased experimental, postoperative, and long-term pain in most cases while changes in sympathetic activity did not consistently predict pain. CONCLUSIONS: Most studies demonstrated that parasympathetic activity could predict acute and chronic pain intensity. In the clinic, this may be used to identify which patients need more intensive care to prevent, for example postoperative pain and develop personalized chronic pain management. SIGNIFICANCE: Pain is a debilitating problem, and the ability to predict occurrence and severity would be a useful clinical tool. Basal autonomic tone has been suggested to influence pain perception. This systematic review investigated electrocardiographic-derived autonomic tone and found that increased parasympathetic tone could predict pain reduction in different types of pain.

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.

Self-determination theory interventions versus usual care in people with diabetes: a systematic review with meta-analysis and trial sequential analysis.

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% CI -4.85, 4.86, I2 = 0%; 225 participants, 3 trials, TSA-adjusted CI -11.83, 11.83), all-cause mortality, serious adverse events, diabetes distress, depressive symptoms, adverse events, glycated hemoglobulin A1c, or motivation (controlled). The certainty of the evidence was low to very low for all outcomes. We found beneficial effect on motivation (autonomous and amotivation; low certainty evidence). CONCLUSIONS: We found no effect of self-determination-based interventions on our primary or secondary outcomes. The evidence was of very low certainty. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020181144.

Aromatase Inhibitor-Related Symptoms Reported by Postmenopausal Women with Nonmetastatic, Estrogen Receptor-Positive Breast Cancer: A Systematic Review.

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.

Interrelations between clinical-psychological features and bone mineral density changes in post-menopausal women undergoing anti-osteoporotic treatment: a two-year follow-up.

Introduction: Psychological features have been bidirectionally associated with osteoporosis, but it is still unclear whether patient's anxiety fluctuations during the anti-osteoporotic treatment can have an impact on bone mineral density (BMD) variation. The aim of this study was to investigate the interrelations between psychological distress features, such as anxiety, depression, health-related QoL (HRQoL) and bone health in women receiving anti-osteoporotic treatment. Methods: 192 post-menopausal osteoporotic women were treated with alendronate or risedronate according to the standard procedure. The levels of anxiety, depression, and perceived HRQoL, along with BMD, were assessed at baseline and at a 2-year follow-up. Results: At the end of the study, the patients showed a statistically significant increase of both psychic and somatic anxiety (p<0.0001) and exhibited a worsening of depressive symptoms (p<0.0001), whereas HRQoL showed no change. BMD improved and no incident fractures occurred. BMD variation (ΔBMD) at lumbar spine was significantly associated with anxiety levels (r=0.23, p=0.021). Multiple regression analysis showed that both patients' worsening anxiety levels (ß = -0.1283, SE=0.06142, p=0.04) and their treatment adherence (ß=0.09, SE=0.02, p=0.0006) were independently associated with ΔBMD. Discussion: The findings of the current follow-up study suggest that BMD in post-menopausal women undergoing anti-osteoporotic treatment was predicted by treatment adherence and anxiety change over time.

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.

Quantitative sensory testing as an assessment tool to predict the response to standard pain treatment in knee osteoarthritis: a systematic review and meta-analysis.

Emerging evidence suggest that quantitative sensory testing (QST) may predict the treatment response to pain-relieving therapies. This systematic review and meta-analysis focus on the predictive value of QST for pain management of knee osteoarthritis (OA). MEDLINE and EMBASE were systematically searched for all studies from year 2000 to 2023 on pretreatment QST and treatment of OA including surgical, pharmaceutical, and nonsurgical and nonpharmaceutical therapies. Preclinical studies and reviews were excluded. The systematic review followed the PRISMA guidelines and was pre-registered on the Open Science Framework website (link: https://osf.io/4FETK/, Identifier: DOI 10.17605/OSF.IO/4FETK). Meta-analysis were conducted to demonstrate the strength of the pre-treatment QST predictions on pain outcomes after OA treatments. Sixteen surgical (all on total knee arthroplasty [TKA], N = 1967), 5 pharmaceutical (4 on non-steroidal anti-inflammatory drugs [NSAIDs], N = 271), and 4 exercise-based therapy studies (N = 232) were identified. Pretreatment QST parameters predicted pain-relieving treatment outcomes in 81% of surgical, 100% of pharmaceutical, and 50% of exercise-based therapy studies. Meta-analyses found pretreatment QST profiles to predicted pain outcomes after TKA (random effects: 0.309, 95% confidence interval [CI]: 0.206-0.405, P < 0.001), NSAIDs (random effects: 0.323, 95% CI: 0.194-0.441, P < 0.001), and exercise-based therapies (random effects: 0.417, 95% CI: 0.138-0.635, P = 0.004). The overall risk of bias for the included studies was low to moderate. This systematic review and meta-analysis demonstrate weak-to-moderate associations between pretreatment QST and pain outcomes after standard OA pain treatments. Based on this work, it is hypothesized that a subset of specific pain sensitive patients with OA exist and that these patients do not respond adequately to standard OA pain treatments.

Weight Change in Post-Menopausal Women with Breast Cancer during Chemotherapy-Perspectives on Nutrition, Activity and Bone Metabolism: An Interim Analysis of a 5-Year Prospective Cohort.

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.

FRAX Calculated without BMD Resulting in a Higher Fracture Risk Than That Calculated with BMD in Women with Early Breast Cancer.

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 significant difference (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 stratified by age, patients aged 65 years or older were at a significantly (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.