The implementation of the 2017 national policy on patient-reported outcomes in Denmark: An overview of developments after six years.

Driven by the potential values of using more patient-centred approaches in health care, the Danish government, regions and municipalities have agreed to introduce a standardised use of patient-reported outcomes (PRO) in all healthcare sectors in Denmark. Expecting benefits in particular at the individual patient level, the work to implement the national PRO policy is carried out under the auspices of the Ministry of Health. This highly systematic and comprehensive work elevates the development of PRO to a national level and centres around three main elements: development and feasibility tests of standardised PRO instruments within specific clinical areas, the development and implementation of a PRO instrument repository and a national IT infrastructure for the sharing of data across healthcare sectors. The paper describes these elements together with reports on the current state of implementation after six years of activities. PRO instruments have been developed and tested within eight clinical areas and - as intended - they show promising value for patients as well as healthcare professionals with respect to individual patient care. It has taken time for the supporting IT infrastructure to become fully operational in practice and, likewise, the strengthening of the implementation in and across healthcare sectors has required - and continues to require - considerable efforts from all stakeholders.

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.

Development of a model for shared care between general practice and mental healthcare: a protocol for a co-production study.

INTRODUCTION: Mental health illness represents one of the greatest health burdens in the world. It is well documented that treatment of these illnesses could be optimised through strengthened collaboration between general practice and specialised mental healthcare services (shared care). Furthermore, involvement of users in the design of new interventions to strengthen end-user value and sustainability is key. Therefore, the aim of this study is to develop a shared care intervention in co-production with users. METHODS AND ANALYSIS: The study will take place at psychiatric outpatient clinics in Denmark.The project is described in four sequential steps, each informing and leading into the next: a systematic review (step 1) will be followed by an exploratory study investigating how stakeholders (general practitioners, mental healthcare staff and patients) perceive existing treatment and collaboration between general practice and mental health services. Steps 1 and 2 will inform and qualify the intervention that will be developed in step 3 as a co-creation study. Step 4 will assess the intervention in a feasibility study. Step 4 will be designed as a non-randomised intervention study with a control group with preassessments and postassessments. In total, 240 patients will be recruited. Questionnaires will be administered to the participants at their first visit to an outpatient clinic and again after 3 months. The primary outcome will be patients' self-reported mental health status (Short Form Health Survey, SF-36) and recovery (revised Recovery Assessment Scale, RAS-R). Recruitment will take place from June 2023 to May 2024. ETHICS AND DISSEMINATION: The project is approved by the ethics committee (REG-016-2022). Informed consent based on written and verbal information about the aims, purpose and use of the study and the data collection will be obtained from all participants. The study findings will be published in peer-reviewed journals and presented at national and international conferences. The study is registered at ClinicalTrials.gov. TRIAL REGISTRATION NUMBER: NCT05172375. PROSPERO REGISTRATION NUMBER: 287989.

Assessment of functioning and disability in patients with low back pain - the low back pain assessment tool. Part 2: field-testing.

PURPOSE: To evaluate comprehensiveness and acceptability of the patient-reported outcome instrument (PRO-LBP) and the clinician-reported outcome instrument (ClinRO-LBP) included in the low back pain (LBP) assessment tool. Second, to assess degree of implementation after three months. METHODS: Feasibility-testing, training of health professionals, field-testing, and a feedback meeting was undertaken. Field-testing provided data to evaluate comprehensiveness, acceptability, and degree of implementation. RESULTS: Feasibility-testing and training of health professionals revealed that the LBP assessment tool was usable and ready for field-testing. In total, 152 patients participated in the field-testing of whom 95% considered the PRO-LBP comprehensive and 59% found it acceptable. Health professionals found the ClinRO-LBP comprehensive and acceptable. The feedback meeting revealed that the LBP assessment tool broadened the health professionals' approach to functioning and facilitated a consultation based on the patient perspective. The degree of implementation reached 79%. CONCLUSIONS: The PRO-LBP and the ClinRO-LBP covered key concepts of LBP and were found acceptable by patients and health professionals. Despite the reduced degree of implementation after three months the LBP assessment tool allowed the health professionals to apply a biopsychosocial and patient-centred approach. Future research should investigate whether the LBP assessment can enhance patient-centred care.Implications for rehabilitationThe low back pain (LBP) assessment tool is the first evidence-based tangible tool to cover biopsychosocial aspects related to LBP as defined by the International Classification of Functioning, Disability and Health (ICF).The LBP assessment tool allowed health professionals to apply a biopsychosocial and patients-centred approach and has the potential to be used in rehabilitation planning.Awareness to continuous facilitation and training of health professionals is important to facilitate and maintain implementation of new procedures into routine clinical practice.

Assessment of functioning and disability in patients with low back pain - the low back pain assessment tool. Part 1: development.

PURPOSE: To present the process used to develop the low back pain (LBP) assessment tool including evaluation of the initial content validity of the tool. METHODS: The development process comprised the elements: definition of construct and content, literature search, item generation, needs assessment, piloting, adaptations, design, and technical production. The LBP assessment tool was developed to assess the construct "functioning and disability" as defined by the International Classification of Functioning, Disability and Health (ICF). Involvement of patients and health professionals was essential. RESULTS: The elements were collapsed into five steps. In total, 18 patients and 12 health professionals contributed to the content and the design of the tool. The LBP assessment tool covered all ICF components shared among 63 ICF categories. CONCLUSIONS: This study presents the process used to develop the LBP assessment tool, which is the first tool to address all ICF components and integrate biopsychosocial perspectives provided by patients and health professionals in the same tool. Initial evaluation of content validity showed adequate reflection of the construct "functioning and disability". Further work on the way will evaluate comprehensiveness, acceptability, and degree of implementation of the LBP assessment tool to strengthen its use for clinical practice.Implications for RehabilitationA biopsychosocial and patients-centred approach is a strong foundation for identifying the many relevant aspects related to low back pain (LBP).Responding to a lack of tools to support a biopsychosocial and patients-centred approach the LBP assessment tool was developed using a robust, multi-step process with involvement of patients and health professionals.The LBP assessment tool is a strong candidate for a user-friendly tool to facilitate use of the International Classification of Functioning, Disability and Health in routine clinical practice.

ICF-Based Assessment of Functioning in Daily Clinical Practice. A Promising Direction Toward Patient-Centred Care in Patients With Low Back Pain.

Background: Patient-centred care has received increased attention in recent years. Patient-Reported Outcomes (PROs) and shared decision-making are key components of Patient-Centred care. Low back pain (LBP) is a complex symptom affected by multiple, interacting factors. Therefore, evidence strongly recommend a biopsychosocial and patient-centred approach in the assessment and management. The International Classification of Functioning, Disability and Health (ICF) provide a biopsychosocial model for describing functioning and disability. ICF is widely acknowledged, but implementation into clinical practice is lacking. To support the use of a biopsychosocial and patient-centred approach in daily clinical practice among patients with LBP we developed a practice-friendly tool based on ICF; the LBP assessment tool. Objective: To compare an ICF-based assessment facilitated by the LBP assessment tool with standard care in terms of the use of PROs and shared decision-making in order to promote patient-centred care in patients with LBP. Methods: A non-randomized controlled design was used. Eligible patients were allocated to one of two groups: the ICF group, assessed with the LBP assessment tool or the control group, assessed with a conventional LBP assessment. Primary outcome includes use of PROs. Secondary outcomes include use of a graphical overview displaying the patient profile and shared decision-making. A patient evaluation questionnaire was used to collect data. Results: Seven hundred ten patients were assessed for eligibility of whom 531 were allocated to the ICF group (n = 299) or the control group (n = 232). A significantly higher use of PRO data (p < 0.00) and the patient profile (p < 0.00) was reported in favor of the ICF group. Patients in the ICF group also experienced being more involved in decision-making (p = 0.01). Conclusions: This study showed that a functioning assessment, by means of the LBP assessment tool, increased use of PROs and shared decision-making when compared to a conventional LBP assessment. Additionally, this study demonstrated that routine use of ICF-based PRO data and shared decision-making promoted patient-centred care in patients with LBP. The LBP assessment tool may be a strong candidate for a user-friendly ICF-based tool with the potential to support health professionals in a shift toward a biopsychosocial and patient-centred approach to patients with LBP.

Learning from patient involvement in a clinical study analyzing PET/CT in women with advanced breast cancer.

BACKGROUND: Despite increasing interest in patient involvement in health care research, researchers may be uncertain about the benefits of involving patients in the design and conduction of clinical studies. We aimed to evaluate the impact of patient involvement on patient recruitment and retention in a clinical study of PET/CT in women with advanced breast cancer. Further, we report our experience regarding the researchers' attitudes towards involving patients as partners in the research process. METHODS: Two patient representatives from the Danish Breast Cancer Organization were invited as partners in the research team. These patient partners were asked to contribute in particular to participator information material and evaluation of ethical aspects of the study. The impact of patient involvement on patient recruitment was evaluated by comparing expected versus actual number of patients recruited, and then relating it to patient recruitment in a similar study at the same institution that did not involve patients as research partners. RESULTS: Having patients as partners in the research team led to a major revision of the participator information material and improved patient recruitment. The expected number of patients was 260, but 380 were actually enrolled within the planned study period, thus 146% of the expected patient recruitment. In the previous study, only 100 of the expected 150 patients were enrolled during a 10-month extended study period, i.e. 67% of the expected number. Patient retention in the current study was high, with 86% of eligible patients attending follow-up scans. We observed initial resistance amongst researchers against inviting patients as team partners. This resistance gradually lessened during the study, and the most reluctant researchers at the beginning of the study later applauded the collaboration and the ideas generated by the patient representatives. CONCLUSION: Involving patients as partners in the research team resulted in major changes to the participator information material and contributed to higher than expected patient recruitment and retention. Furthermore, we observed a positive change of attitude amongst the researchers towards patient involvement in the research process. TRIAL REGISTRATION: Ongoing study: ClinicalTrials.gov (NCT03358589).Previous study: ClinicalTrials.gov (NCT01552655).

Supplementation with orange and blackcurrant juice, but not vitamin E, improves inflammatory markers in patients with peripheral arterial disease.

Inflammation and endothelial activation are associated with an increased risk of CVD and epidemiological evidence suggests an association between levels of markers of inflammation or endothelial activation and the intake of fruit. Also, vitamin E, a fat-soluble antioxidant, has anti-inflammatory properties. We performed a randomised 2 x 2 factorial, crossover trial to determine the effect of orange and blackcurrant juice (500 ml/d) and vitamin E (15 mg RRR-alpha-tocopherol/d) supplementation on markers of inflammation and endothelial activation in forty-eight patients with peripheral arterial disease. Patients were randomly allocated to two dietary supplements from the four possible combinations of juice and vitamin E: juice+vitamin E; juice+placebo; reference beverage (sugar drink)+vitamin E; and reference beverage+placebo. The supplementations were given for 28 d, separated by a 4-week wash-out period. Analysis of main effects showed that juice decreased C-reactive protein (CRP) by 11% and fibrinogen by 3% while the reference drink increased CRP by 13% and fibrinogen by 2% (P<0.008 and P<0.002, respectively). No significant differences were measured for IL-6 and the endothelial activation markers von Willebrand factor, tissue-plasminogen activator and plasmin activator inhibitor-1. Vitamin E supplementation had no significant effects on the various markers. We observed no significant interaction between juice and vitamin E. In this study, orange and blackcurrant juice reduced markers of inflammation, but not markers of endothelial activation, in patients with peripheral arterial disease, relative to sugar drinks.

Changes in levels of haemoglobin A1c during the first 6 years after diagnosis of clinical type 2 diabetes.

OBJECTIVE: To assess the variability in levels of glycosylated haemoglobin (HbA(1c)) during the first six years after diagnosis of clinical type 2 diabetes in relation to possible predictors. MATERIAL AND METHODS: Data were from a population-based sample from general practice of 581 newly diagnosed diabetic patients aged 40 or over. Estimation of HbA(1c) was centralized. The changes in levels of HbA(1c) were described by HbA(1c) at diagnosis and a regression line fitted to the HbA(1c) measurements after 1-year follow-up for each patient. The predictive effect of patient characteristics for changes in HbA(1c) was investigated in a multivariate mixed model. RESULTS: During the first year after diabetes diagnosis, HbA(1c) dropped to near normal average level and then started rising almost linearly. A sharp rise in long-term glycaemic level was observed in approximately a quarter of the patients, especially the relatively young. Of 581 patients, 156 (26.9%) patients, however, experienced a fall in HbA(1c) after 1-year follow-up and another quarter showed constant or only slowly rising HbA(1c). The changes in levels of HbA(1c) were only predicted by diagnostic HbA(1c) and age. CONCLUSIONS: During the first 6 years after the diagnosis of clinical type 2 diabetes, changes in levels of HbA(1c) show considerable inter-individual variability with age as the only long-term predictor. The results indicate that it is important to monitor changes in HbA(1c) more closely and intensify treatment of those often relatively young patients who actually experience the beginning of an apparently relentless deterioration of their glycaemic control.

"Keep it simple": Perspectives of patients with low back pain on how to qualify a patient-centred consultation using patient-reported outcomes.

BACKGROUND: Patient-reported outcomes are expected to play an important role in patient-centred health care. To capture patients' perspectives, patient involvement in the development of patient-reported outcome (PRO) instruments is essential, but often lacking. This qualitative study explored the perspectives of patients with low back pain, to gain an understanding of how to qualify a patient-centred consultation by using PROs. This was done by exploring patients' perspectives regarding the assessment of functioning and disability as part of the development of a new PRO instrument based on the International Classification of Functioning, Disability and Health Core Set. METHODS: Semi-structured focus group interviews with seven patients with low back pain were conducted. Data were analysed by drawing on the Interpretive Description methodology. RESULTS: The analysis revealed three core themes: simplicity, individuality and application. Simplicity represented keeping items to a minimum and avoiding overlaps; individuality implied the need for individualized answers; and application signified that PROs should be utilized during the consultation, and that they can provide useful information for clinical decision-making. CONCLUSIONS: The study provides essential knowledge about elements of importance to patients with low back pain when aiming for a patient-centred consultation using PROs. Furthermore, it underlines the importance of involving patients in PRO development because their perspectives improved the new PRO instrument.

[The challenges faced by researchers involving patients as partners in research].

This review presents recent findings from the literature on the challenges that researchers may face, when patients get involved as partners in research: which patients to recruit, how to clarify and set boundaries to the roles of the patient and the researcher, and how to evaluate the outcome of involvement. Patient involvement may challenge the professional identity of a researcher. Researchers are often uncertain about how to establish a meaningful collaboration with partners whose knowledge comes from the lived experience of being a patient.

No influence of increased intake of orange and blackcurrant juices and dietary amounts of vitamin E on paraoxonase-1 activity in patients with peripheral arterial disease.

BACKGROUND: Paraoxonase-1 (PON1) is an antioxidative enzyme associated with HDL and its serum activity is associated with risk of cardiovascular disease. The interindividual variation in PON1 activity is partly determined by genetic factors, such as polymorphisms in the PON1 gene, but also by dietary factors like the antioxidants. AIM OF THE STUDY: We examined the effect of antioxidant-rich orange and blackcurrant juices and vitamin E supplement on PON1 activity in patients with peripheral arterial disease. Furthermore, we studied whether genetic polymorphisms in the PON1 gene predicted the change in PON1 activity. METHODS: The study was designed as a cross-over trial with 48 participants who received two of the four possible treatments: (1) 250 ml orange juice and 250 ml blackcurrant juice; (2) 15 mg vitamin E; (3) 250 ml orange juice and 250 ml blackcurrant juice and 15 mg vitamin E; or (4) control/placebo (energy-equivalent sugar-containing beverage). The treatments were given for 28 days, separated by a 4-week wash-out period. RESULTS: The PON1 activity was not affected by juice or vitamin E supplement neither was there evidence of synergetic effects. However, a statistically significant interaction was observed between treatment and PON1 genotype, such that PON1 activity increased after juice alone in patients carrying the PON1 L55-allele. Results need to be interpreted with care since the study population was relatively small. CONCLUSION: Consumption of orange and blackcurrant juice and vitamin E supplement does not affect the activity of PON1 in patients with peripheral arterial disease. However, a gene-diet interaction may be present.

International comparison of the definition and the practical application of health technology assessment.

OBJECTIVES: Health Technology Assessment (HTA) is defined as a policy research approach that examines the short- and long-term social consequences of the application or use of technology. Internationally different institutions have translated this definition to local contexts. In Denmark, HTA is comprehensive with focus on four aspects of the problem in question (technology [clinical evidence], economy, patient, and organization). The objective of this study is to study how the application of HTA differs across leading countries and to study the extent to which Danish HTA reports differ from foreign HTAs. METHODS: A sample of 433 HTA reports published in the period 1989--2002 by eleven leading institutions or agencies in Denmark and eight other countries were reviewed. We looked at the characteristics of the HTA with respect to focus on the four main aspects and the manner in which each aspect has been approached. RESULTS: The study shows health technology procedures to be the most common type of health technology assessed in HTAs and literature review to be the most often used method of analysis. Policy recommendations are only present in approximately half of the HTA reports. CONCLUSIONS: In the HTAs one generally sees a great focus on the clinical aspect of health technologies, leaving the economic, the patient-related, and the organizational aspect much more unanalyzed. The Danish HTAs generally have a wider scope than HTAs produced in other countries and tend to focus more frequently on patient-related and organizational dimensions.

Familial and sporadic porphyria cutanea tarda: clinical, biochemical and genetic features with emphasis on iron status.

The manifestation of porphyria cutanea tarda reflects genetic and environmental factors. Mutations in the uroporphyrinogen decarboxylase gene, located at chromosome 1p34, discriminate familial porphyria cutanea tarda from sporadic cases. Furthermore, mutations in the haemochromatosis gene may be involved in the aetiology. In this study 53 unrelated Danish patients with porphyria cutanea tarda were classified according to uroporphyrinogen decarboxylase and haemochromatosis gene mutations and the genotype related to the clinical and biochemical data. Thirteen patients (25%) had familial porphyria cutanea tarda. The results signify the advantage of DNA diagnostics for identification of familial cases, as anamnestic data are doubtful and erythrocyte uroporphyrinogen decarboxylase activity measurements insufficient for correct classification. Eight patients with porphyria cutanea tarda (15%) were homozygous for the haemochromatosis gene C282Y mutation and 8 patients were heterozygous. Patients homozygous for the haemochromatosis related mutation showed biochemical evidence of excessive iron storage as well as increased urine porphyrin excretion levels. This seems to confirm a relationship between porphyria cutanea tarda and haemochromatosis. No differences were found between patients with sporadic and familial porphyria cutanea tarda regarding age of onset, clinical severity, sex distribution, liver function tests and iron storage parameters. However, daily alcohol intake and use of oestrogens were reported more frequently in the group of sporadic patients. It was found that women were over-represented in our study.

Recomendação aprovada (1985) para métodos da IFCC de medida de concentração catalítica de enzimas: parte 3: Método IFCC para alanina aminotransferase / Recommendation approved (1985) IFCC methods for measurement of catalytic concentration of enzymes: part 3: IFCC method for alanine aminotransferase

Este trabalho está baseado na Recomendação Provisória (1), revista de modo a levar em conta os comentários recebidos, e foi aceito pelo Conselho da Federação Internacional de Química Clínica (IFCC) em votação procedida em 1985. Este trabalho constitui parte de uma série de recomendações sobre medições de concentrações catalíticas de enzimas. As demais referem -se ao seguinte: Parte 1. Condições gerais (2) Parte 2. Método para Aspartato Aminotransferase (3) Parte 4. Método para δ — glutamiltransferase (4) Parte 5. Método para Fosfatase Alcalina (5) Parte 6. Materiais de Referência para medição de Enzimas Parte 7. Método para Creatina Quinase.