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Background Since 2012, Cancer Patient Pathways for Non-specific Symptoms and Signs of Cancer (NSSC-CPP) have been implemented in Scandinavia and UK.Objectives This study aimed to describe the diagnostic flow for all patients referred from 1 January to 30 June 2020 to the NSSC-CPP in the Diagnostic Centre in Farsø (DC-F), Denmark.Methods During the study period, we prospectively recorded information on the diagnostic flow, including: pathway trajectory, symptoms and findings leading to referral, diagnostic procedures and diagnoses at the end of DC Farsø work-up and within 6-months for all patients referred to the NSSC-CPP in DC Farsø using electronic patient files and the Danish National Patient Registry (DNPR).Results Of the 314 referrals to DC Farsø, 227 had diagnostic work-up in DC Farsø, the remaining were redirected to other CPPs (n = 11), outpatient clinics (n = 45) or redirected to general practice (n = 25). Of total referrals, 25 (8%) received a malignant diagnosis, 20 (6%) a non-malignant but clinically relevant diagnosis with initiation of treatment, 16 (5%) a non-malignant diagnosis but no treatment needed and in 253 (81%) referrals no severe new condition was diagnosed. Two (1%) additional malignancies were diagnosed within a 6-month follow-up period.Conclusion By tracking all patients referred to the NSSC-CPP in DC Farsø, including those redirected, this is the first study to describe the diagnostic flow for all patients referred to a diagnostic centre in Denmark. This knowledge is important for further organisation and planning of the NSSC-CPP.

Introduction Many types of prostate cancer present minimal risk to a man’s lifespan or well-being, but existing terminology makes it difficult for men to distinguish these from high-risk prostate cancers. This study aims to explore whether using an alternative label for low-risk prostate cancer influences management choice and anxiety levels among Australian men and their partners.Methods and analysis We will run two separate studies for Australian men and Australian women with a male partner. Both studies are between-subjects factorial (3×2) randomised online hypothetical experiments. Following consent, eligible participants will be randomised 1:1:1 to three labels: ‘low-risk prostate cancer, Gleason Group 1’, ‘low-risk prostate neoplasm’ or ‘low-risk prostate lesion’. Participants will then undergo a second randomisation step with 1:1 allocation to the provision of detailed information on the benefits and harms of different management choices versus the provision of less detailed information about management choices. The required sample sizes are 1290 men and 1410 women. The primary outcome is the participant choice of their preferred management strategy: no immediate treatment (prostate-specific antigen (PSA)-based monitoring or active surveillance using PSA, MRI, biopsy with delayed treatment for disease progression) versus immediate treatment (prostatectomy or radiation therapy). Secondary outcomes include preferred management choice (from the four options listed above), diagnosis anxiety, management choice anxiety and management choice at a later time point (for participants who initially choose a monitoring strategy).Ethics and dissemination Ethics approval has been received from The University of Sydney Human Research Ethics Committee (2023/572). The results of the study will be published in a peer-reviewed medical journal and a plain language summary of the findings will be shared on the Wiser Healthcare publications page http://www.wiserhealthcare.org.au/category/publications/Trial registration numbers Australian New Zealand Clinical Trials Registry (ID 386701 and 386889).

Abstract Background Patients dealing with severe mental illnesses (SMI) often face suboptimal clinical outcomes and higher mortality rates due to a range of factors, including undetected physical health conditions. The provision of care for individuals with SMI is frequently disjointed, as they engage with diverse healthcare providers. Despite this fragmentation, primary care, particularly general practitioners (GPs), assumes a pivotal role in the care of SMI patients. Our study aimed to delve into the first-hand experiences of GPs in delivering somatic care to SMI patients, concentrating on the challenges they encounter and the strategies they employ to navigate these difficulties. Methods We conducted in-depth interviews with fifteen GPs, utilizing a semi-structured interview guide, supplemented by ethnographic observations during clinical consultations in general practice. Through inductive coding, interview transcripts and observational field notes were systematically analysed using interpretative phenomenological analysis (IPA). The findings were then deliberated upon within the author group. Results GPs revealed that managing the chronic somatic care of SMI patients posed significant challenges. These challenges encompassed the multifaceted needs of patients, their behavior tied to symptoms, a lack of care continuity, and overarching time constraints. To tackle these challenges, the GPs had devised various strategies. However, all participants underscored the critical importance of having adequate time to properly prepare for, conduct, and follow up on consultations. Conclusion The GPs’ interactions with SMI patients brought numerous challenges, although treating these patients were concurrently acknowledged as vital and fulfilling. The findings suggest that increased allocated time in general practice consultations for patients with SMI is important to support the somatic treatment requirements of this patient group.

BackgroundUncomplicated urinary tract infections (UTIs) in women are among the most common bacterial infections in primary care. Given the health threats related to the overuse of antibiotics, alternative options are of increasing importance. Patient-reported outcome measures are valuable tools for including the patients’ perspective when evaluating the efficacy of these strategies. Aiming to identify a suitable instrument to measure the severity and bothersomeness of UTI symptoms in women, we performed a systematic review of the literature and identified the Holm and Cordoba Urinary Tract Infection Score (HCUTI), which measures the severity, bothersomeness, and impact of uncomplicated UTIs on daily activities. This instrument showed sufficient content validity but needs translation and further validation before it can be used in German research. ObjectiveFor use in the German setting, we aim (1) to perform translation and linguistic validation of the HCUTI and (2) to evaluate content validity and psychometric properties of the German version of the HCUTI in a population of women with uncomplicated UTIs. MethodsThe HCUTI will be translated and linguistically validated using the dual-panel method. This process involves a bilingual translation panel and a lay panel to check the comprehensibility of the translation. Content validity of the translated questionnaire will be assessed using cognitive interviews according to the criteria for good content validity as recommended by the COSMIN (Consensus-based Standards for the selection of health Measurement Instruments) group involving women with uncomplicated UTIs and health care professionals. Subsequent psychometric validation of the German version of the HCUTI in a population of women with uncomplicated UTIs will include the assessment of structural validity, internal consistency, test-retest reliability, construct validity, responsiveness, and interpretability. ResultsResults of the translation and linguistic validation process and the results of the content validity study were obtained in September 2023 and will be published separately. Data on the psychometric properties of the German version of the HCUTI are anticipated in mid-2024. ConclusionsWe expect that data from the content validity study will provide important suggestions for potential modifications of the HCUTI for use in the German setting. The final version of the questionnaire will be used for the assessment of its psychometric properties in a large population of women with uncomplicated UTIs. International Registered Report Identifier (IRRID)PRR1-10.2196/49903

Abstract Background Multimorbidity is a burden for the individual and to the healthcare sector worldwide, leading to a rising number of intervention studies towards this patient group. To measure a possible effect of such interventions, an adequate patient-reported outcome measure (PROM) is essential. The aim of this study was to assess the draft MultiMorbidity Questionnaire (MMQ), a PROM measuring needs-based quality of life and self-perceived inequity in patients with multimorbidity, for its psychometric properties and to adjust it accordingly to create a content- and construct valid measure. Methods The draft MMQ was sent to 1198 eligible respondents with multimorbidity. Modern test theory and classical test theory were used to analyse data. Dimensionality of the suggested domains and invariance of the items were assessed through item analysis, examining the fit to a psychometric model. Results The psychometric analyses were based on responses from 390 patients with multimorbidity. In the MMQ1, measuring needs-based QoL, evidence of six unidimensional scales was confirmed: physical ability (6 items), worries (6 items), limitations in everyday life (10 items), my social life (6 items), self-image (6 items), and personal finances (3 items). The psychometric analyses of the MMQ2 outlined four unidimensional scales measuring the feeling of Self-perceived inequity in patients with multimorbidity: experiences of being stigmatised (4–5 items), Experiences of insufficient understanding of the burden of disease (3 items), Experiences of not being seen and heard (4 items), Experience of powerlessness (5 items). These scales are relevant for patients’ with multimorbidity encounters with (1) their general pratitioner, (2) staff at their general practitioner’s surgery, (3) healthcare professionals, (4) staff at the local authorities and (5) friends, family, and others. Conclusion The MMQ, a QoL measure for patients living with multimorbidity has been validated: the MMQ1 is a condition-specific PROM with adequate psychometric properties designed to measure needs-based QoL. The MMQ2 measuring Self-perceived inequity, has also been found to possess adequate measurement properties; however due to the risk of type 2 error a revalidation of MMQ2 is suggested.

Abstract Objective To evaluate the feasibility and fidelity of implementing and assessing the SOFIA coordinated care program aimed at lowering mortality and increasing quality of life in patients with severe mental illness by improving somatic health care in general practice. Design A cluster-randomised, non-blinded controlled pilot trial. Setting General Practice in Denmark. Intervention The SOFIA coordinated care program comprised extended structured consultations carried out by the GP, group-based training of GPs and staff, and a handbook with information on signposting patients to relevant municipal, health, and social initiatives. Patients Persons aged 18 years or older with a diagnosis of psychotic, bipolar, or severe depressive disorder. Main outcome measures We collected quantitative data on the delivery, recruitment and retention rates of practices and patients, and response rates of questionnaires MMQ and EQ-5D-5 L. Results From November 2020 to March 2021, nine practices were enrolled and assigned in a 2:1 ratio to the intervention group (n = 6) or control group (n = 3). Intervention group practices included 64 patients and Control practices included 23. The extended consultations were delivered with a high level of fidelity in the general practices; however, thresholds for collecting outcome measures, and recruitment of practices and patients were not reached. Conclusion Our findings suggest that delivering the coordinated care program in a fully powered trial in primary care is likely feasible. However, the recruitment methodology requires improvement to ensure sufficient recruitment and minimize selective inclusion. Trial registration The date of pilot trial protocol registration was 05/11/2020, and the registration number is NCT04618250.

Objective: Ductal carcinoma in situ (DCIS) is a risk factor for invasive breast cancer (IBC). The prognosis of DCIS is considerably better than for IBC, yet women do not distinguish between the threat. We aimed to compare the psychosocial consequences of screen-detected DCIS and IBC, and to examine this comparison over time. Methods: We surveyed a Danish mammography-screening cohort from 2004 to 2018. We assessed outcomes at six-time points: baseline, 1, 6, 18, 36 months, and 14 years after the screening. We measured psychosocial consequences with the Consequences Of Screening – Breast Cancer (COS-BC): a condition-specific questionnaire that is psychometrically validated and encompasses 14 psychosocial dimensions. We used weighted linear models with generalized estimating equations to compare responses between groups. We used a 1% level of significance. Results: 170 out of 1309 women were diagnosed with breast cancer (13.0%). 23 were diagnosed with DCIS (13.5%) and 147 with IBC (86.5%). From baseline to six months after diagnosis, there were no significant differences between women with DCIS and IBC. However, mean scores indicated that IBC generally was more affected than DCIS. After six months, we observed that women with DCIS and IBC might be affected differently in the long term; mean scores and mean differences showed that IBC were more affected on some scales, while DCIS were on others. Conclusion: Overall, the DCIS and IBC experienced similar levels of psychosocial consequences. Women might benefit from renaming DCIS to exclude cancer nomenclature.

Introduction Patients with complex multimorbidity face a high treatment burden and frequently have low quality of life. General practice is the key organisational setting in terms of offering people with complex multimorbidity integrated, longitudinal, patient-centred care. This protocol describes a pragmatic cluster randomised controlled trial to evaluate the effectiveness of an adaptive, multifaceted intervention in general practice for patients with complex multimorbidity.Methods and analysis In this study, 250 recruited general practices will be randomly assigned 1:1 to either the intervention or control group. The eligible population are adult patients with two or more chronic conditions, at least one contact with secondary care within the last year, taking at least five repeat prescription drugs, living independently, who experience significant problems with their life and health due to their multimorbidity. During 2023 and 2024, intervention practices are financially incentivised to provide an extended consultation based on a patient-centred framework to eligible patients. Control practices continue care as usual. The primary outcome is need-based quality of life. Outcomes will be evaluated using linear and logistic regression models, with clustering considered. The analysis will be performed as intention to treat. In addition, a process evaluation will be carried out and reported elsewhere.Ethics and dissemination The trial will be conducted in compliance with the protocol, the Helsinki Declaration in its most recent form and good clinical practice recommendations, as well as the regulation for informed consent. The study was submitted to the Danish Capital Region Ethical Committee (ref: H-22041229). As defined by Section 2 of the Danish Act on Research Ethics in Research Projects, this project does not constitute a health research project but is considered a quality improvement project that does not require formal ethical approval. All results from the study (whether positive, negative or inconclusive) will be published in peer-reviewed journals.Trial registration number NCT05676541.

Abstract Introduction In Denmark, women are discontinued from mammography screening at age 69 due to decreased likelihood of benefits and increased likelihood of harm. The risk of harm increases with age and includes false positives, overdiagnosis and overtreatment. In a questionnaire survey, 24 women expressed unsolicited concerns about being discontinued from mammography screening due to age. This calls for further investigation of experiences related to discontinuation from screening. Methods We invited the women, who had left comments on the questionnaire, to participate in in‐depth interviews with the purpose to explore their reactions, preferences, and conceptions about mammography screening and discontinuation. The interviews lasted 1–4 h and were followed up with a telephone interview 2 weeks after the initial interview. Results The women had high expectations of the benefits of mammography screening and felt that participation was a moral obligation. Following that, they perceived the screening discontinuation as a result of societal age discrimination and consequently felt devalued. Further, the women perceived the discontinuation as a health threat, felt more susceptible to late diagnosis and death, and therefore sought out new ways to control their risk of breast cancer. Conclusion Our findings indicate that the age‐related discontinuation from mammography screening might be of more importance than previously assumed. This study raises important questions about screening ethics, and we encourage research to explore this in other settings. Patient and Public Contribution This study was conducted as a result of the women's unsolicited concerns about being discontinued from screening. This particular group contributed to the study with their own statements, interpretations and perspectives on the discontinuation of screening, and the initial analysis of data was discussed with the women during follow‐up interviews.

Purpose It can be challenging to research aspects of people’s health behaviour, attitudes, and emotions due to the sensitive nature of these topics. We aimed to develop a novel methodology for discussing sensitive health topics, and explore the effectiveness in focus groups using prostate cancer and screening as an example. Method We developed a fictitious case and employed it as a projective technique in focus groups on prostate cancer and screening. The participants were men and their partners who lived in Denmark. Results The technique encouraged emotional and cognitive openness in focus group discussions about the risk of prostate cancer, the benefits and harms of screening, and decision-making about screening. It appeared that using the fictitious case allowed the participants to personally distance themselves from the topic, project emotions onto the case, and thereby openly talk about their emotions. Conclusion This article presents a methodological contribution to communication about sensitive topics in focus groups, using prostate cancer screening as an example. Further refinement of the methodology is needed to enable participants to transfer improvements in knowledge to their own decision about screening.

Objective The implementation of point-of-care ultrasound (POCUS) in general practice varies, but it is unknown what determines this variation. The purpose of this study was to explore (1) the overall proportion of POCUS-users among general practitioners (GPs), (2) the current use of POCUS by GPs, (3) factors related to the implementation of POCUS in general practice and (4) GPs’ concerns related to POCUS use in general practice.Design An online survey was distributed in June 2019.Setting General practice.Participants GPs working in office-based primary care clinics in Denmark.Main outcome measures The questionnaire was developed using mixed methods and included questions about participants’ characteristics, past POCUS training and experience, capability, opportunity and motivation for using POCUS in the primary care setting. Results were summarised using descriptive statistics. Association between GPs’ background characteristics and POCUS use was tested using logistics regression.Results Responses were analysed from 1216 questionnaires corresponding to 36.4% of all GPs in Denmark. The majority (72.3%) of participants had previous POCUS experience, 14.7% had access to a POCUS device and 11.5% used POCUS. Several factors motivated participants to use POCUS. However, barriers existed such as lack of remuneration and high workload. Additionally, many GPs questioned their ability to scan with sufficient diagnostic accuracy and the impact of POCUS on the consultation. Of non-users, 28.7% believed they would be using POCUS in the future.Conclusion Although, the majority of GPs had past experience with POCUS and felt motivated to use it, few had implemented POCUS. Several factors influenced the GPs’ capability, opportunity and motivation for using POCUS and several concerns were registered by non-users.

Abstract Background Multimorbidity is both an individual and societal problem. For society, patients with multimorbidity increase healthcare costs. For the individual, living with multimorbidity is complex, and there is an inverse relationship between a patient's Quality of Life (QoL) and their number of chronic conditions. Numerous intervention studies target these problems, yet there is no multimorbidity-specific patient-reported outcome measure (PROM) developed specifically for this group with adequate measurement properties to assess QoL. This study explores what overall needs regarding QoL are affected by living with multimorbidity through qualitative interviews. With this, we conceptualise Needs-based QoL specifically for this group, ensuring high content validity (regarding relevance and comprehensiveness) of using the Needs-based approach to measure their QoL. This is essential as this preliminary study leads to the development of the MultiMorbidity Questionnaire (MMQ), a PROM measuring QoL among patients with multimorbidity. Methods This study draws upon qualitative interviews with fifteen patients with multimorbidity based on a semi-structured interview guide following the Needs-based approach. This approach allowed the patients to cover needs relevant for their QoL in relation to the complexities of living with multimorbidity. The transcribed interviews were thematically analysed, inspired by Braun and Clarke’s reflexive approach. Results Analysis of the interviews resulted in the construction of six intertwined domains relevant to patients with multimorbidity, covering their Needs-based QoL; “Physical ability”, “Self-determination”, “Security”, “Partner and social life”, “Self-image”, and “Personal finances”. “Physical limitations” and “Personal finances” were stated as core needs implicating the other domains. Conclusion This study shows six intertwined overall domains relevant for patients with multimorbidity regarding their Needs-based QoL; “Physical ability”, “Self-determination”, “Security”, “Partner and social life”, “Self-image”, and “Personal finances”. These needs are relevant in a Danish context, with a generally high standard of living. Based on this conceptual framework of Need-based QoL for patients with multimorbidity, we will develop items for a new patient-reported outcome measure called the MMQ.

Objective To compare the long-term psychosocial consequences of mammography screening among women with breast cancer, normal results and false-positive results.Design A matched cohort study with follow-up of 12–14 years.Setting Denmark from 2004 to 2019.Participants 1170 women who participated in the Danish mammography screening programme in 2004–2005.Intervention Mammography screening for women aged 50–69 years.Outcome measures We assessed the psychosocial consequences with the Consequences Of Screening–Breast Cancer, a condition-specific questionnaire that is psychometrically validated and encompasses 14 psychosocial dimensions.Results Across all 14 psychosocial outcomes, women with false-positive results averagely reported higher psychosocial consequences compared with women with normal findings. Mean differences were statistically insignificant except for the existential values scale: 0.61 (95% CI (0.15 to 1.06), p=0.009). Additionally, women with false-positive results and women diagnosed with breast cancer were affected in a dose–response manner, where women diagnosed with breast cancer were more affected than women with false-positive results.Conclusion Our study suggests that a false-positive mammogram is associated with increased psychosocial consequences 12–14 years after the screening. This study adds to the harms of mammography screening. The findings should be used to inform decision-making among the invited women and political and governmental decisions about mammography screening programmes.

Resume Antallet af børn og unge som diagnosticeres med en psykisk sygdom er stigende. Det betyder dog ikke, at alle de diagnosticerede børn har en sygdom, fordi denne stigning også delvist kan være et udtryk for overdiagnostik. I denne oversigtsartikel redegør vi for, med baggrund i nyeste viden og publicerede artikler, hvad psykiske diagnoser hos børn er, og hvorfor der kan forekomme overdiagnostik. Vi viser desuden, at opfattelser af det ’normale’ ændres, både fordi symptomer kan blive så udbredte, at det ikke længere giver mening at tale om symptomer, men om normal-tilstande, og fordi der er en øget tendens til at medikalisere og diagnosticere adfærd, der er en reaktion på specifikke begivenheder. Vi argumenterer for, at det er en væsentlig baggrundsviden at have for dem, som er beskæftiget inden for det pædagogiske område, særligt i folkeskolen, hvor børnene har den alder, de oftest diagnosticeres i. Vi slutter derfor med en diskussion af overdiagnostik i et pædagogisk perspektiv. Den pædagogiske faglighed kan være nøglen til at være mere præcis over for, hvordan en given adfærd skal tolkes – og kan derved medvirke til, at færre børn bliver overdiagnosticerede med en diagnose, de aldrig får gavn af. Abstract Leaving Normal? How overdiagnosis enter and form the field of pedagogic practice The number of children and adolescents diagnosed with mental diseases is rising. It does, however, not mean that all these children necessarily have a mental disease; overdiagnosis is a well-known problem among medical researchers, but the pedagogical researchers and staff also need this insight. In this paper, we provide an overview of mental diagnoses among children and adolescents, the diagnostic procedures that may lead to overdiagnosis and how the concept of normal are constantly changing. This is relevant for the pedagogical staff that will evidently meet children with severe and invalidating mental illnesses, but also children, whose illness and symptoms are potentially overdiagnosed. The professional insights from pedagogy and pedagogical research are much needed if we are to improve the diagnostic process by input to better distinguish between the children who will need medical attention – and thus a diagnosis – and children who may have challenges, but not related to any medical conditions.

IntroductionPhysical harm from Colorectal Cancer Screening tends to be inadequately measured and reported in clinical trials. Also, studies of ongoing Colorectal Cancer Screening programs have found more frequent and severe physical harm from screening procedures, e.g., bleeding and perforation, than reported in previous trials. Therefore, the objectives of the study were to systematically review the evidence on the risk of bleeding and perforation in Colorectal Cancer Screening.DesignSystematic review with descriptive statistics and random-effects meta-analyses.MethodsWe systematically searched five databases for studies investigating physical harms related to Colorectal Cancer Screening. We assessed the internal and the external validity using the ROBINS-I tool and the GRADE approach. Harm estimates was calculated using mixed Poisson regression models in random-effect meta-analyses.ResultsWe included 89 studies. Reporting and measurement of harms was inadequate in most studies. In effect, the risk of bias was critical in 97.3% and serious in 98.3% of studies. All GRADE ratings were very low. Based on severe findings with not-critical risk of bias and 30 days follow-up, the risk of bleedings per 100,000 people screened were 8 [2;24] for sigmoidoscopy, 229 [129;408] for colonoscopy following fecal immunochemical test, 68 [39;118] for once-only colonoscopy, and 698 [443;1045] for colonoscopy following any screening tests. The risk of perforations was 88 [56;138] for colonoscopy following fecal immunochemical test and 53 [25;112] for once-only colonoscopy. There were no findings within the subcategory severe perforation with long-term follow-up for colonoscopy following any screening tests and sigmoidoscopy.DiscussionHarm estimates varied widely across studies, reporting and measurement of harms was mostly inadequate, and the risk of bias and GRADE ratings were very poor, collectively leading to underestimation of harm. In effect, we consider our estimates of perforation and bleeding as conservative, highlighting the need for better reporting and measurement in future studies.Trial registrationPROSPERO registration number: CRD42017058844.

Introduction: Digital pathology solutions are increasingly implemented for primary diagnostics in departments of pathology around the world. This has sparked a growing engagement on validation studies to evaluate the diagnostic performance of whole slide imaging (WSI) regarding safety, reliability, and accuracy. The aim of this review was to evaluate the performance of digital pathology for diagnostic purposes compared to light microscopy (LM) in human pathology, based on validation studies designed to assess such technologies. Methods: In this systematic review based on PRISMA guidelines, we analyzed validation studies of WSI compared with LM. We included studies of diagnostic performance of WSI regarding diagnostic test accuracy (DTA) indicators, degree of overdiagnosis, diagnostic concordance, and observer variability as a secondary outcome. Overdiagnosis is (for example) detecting a pathological condition that will either not progress or progress very slowly. Thus, the patient will never get symptoms from this condition and the pathological condition will never be the cause of death. From a search comprising four databases: PubMed, EMBASE, Cochrane Library, and Web of Science, encompassing the period 2010–2021, we selected and screened 12 peer-reviewed articles that fulfilled our selection criteria. Risk of bias was conducted through QUADAS-2 tool, and data analysis and synthesis were performed in a qualitative format. Results: We found that diagnostic performance of WSI was not inferior to LM for DTA indicators, concordance, and observer variability. The degree of overdiagnosis was not explicitly reported in any of the studies, while the term itself was used in one study and could be implicitly calculated in another. Conclusion: WSI had an overall high diagnostic accuracy based on traditional accuracy measurements; however, the degree of overdiagnosis is unknown.