Children born preterm or small for gestational age to mothers with multiple sclerosis: Do these children have an increased risk of infections in early life?

BACKGROUND: Mothers with multiple sclerosis are at increased risk of preterm birth and small for gestational age infants. Both conditions pose a risk of morbidity, including early-life infections. OBJECTIVE: This study aimed to assess the risk of infections in the first 3 years of life among children born preterm or small for gestational age to mothers with multiple sclerosis. METHODS: We used Danish national health registers to establish the study cohort of all births by women with MS born from 1995 to 2023. In Cox regression models, we estimated hazard ratios (HRs) of infections in preterm or small for gestational age children. RESULTS: Preterm children had an adjusted HR of 1.49 (95% confidence interval (95% CI) 1.15-1.93) for hospital-diagnosed infection and 0.88 (95% CI 0.72-1.06) for antibiotic prescriptions. Small for gestational age children had an adjusted HR of 0.81 (95% CI 0.54-1.22) for hospital-diagnosed infection and 1.07 (95% CI 0.82-1.38) for antibiotic prescriptions. CONCLUSION: Children born preterm to mothers with multiple sclerosis had an increased risk of hospital-diagnosed infections in the first 3 years of life, but not of mild-to-moderate infections evaluated on prescriptions. Children born small for gestational age did not have an increased risk of infections.

Neonatal outcomes in women with Multiple Sclerosis - Influence of disease activity: A Danish nationwide cohort study.

BACKGROUND: Maternal Multiple Sclerosis (MS) has been associated with an increased risk of adverse birth outcomes. We hypothesized that active disease during conception and pregnancy plays an important role in this context, which this study aims to address. METHODS: We used the Danish registers to conduct a nationwide cohort study. Information on maternal disease activity during pregnancy was retrieved using proxies from the linked registers (hospitalization, magnetic resonance imaging of the brain, and use of systemic corticosteroids during pregnancy). Neonates, exposed in utero to maternal disease activity constituted the exposed cohort and the unexposed cohort constituted neonates without in utero exposure to maternal disease activity. The examined outcomes were preterm birth, small for gestational age, low 5-minute Apgar score, and major congenital anomalies. In logistic regression models we estimated the odds ratios (OR) with adjustment for confounders such as maternal age, comorbidities, parity, smoking, calendar year of birth, and disease-modifying treatment. RESULTS: Among the study population of 2492 children of mothers with MS we identified 273 (11 %) neonates exposed to maternal disease activity during pregnancy, and 2219 (89 %) neonates without exposure to disease activity. The adjusted odds ratios (aOR) for preterm birth, small for gestational age, low 5-minute Apgar score, and major congenital anomalies among children born to women with disease activity during pregnancy were 0.92 (95 % confidence interval (95 % CI) 0.53-1.60), aOR 1.19 (95 % CI 0.62-2.26), aOR 2.57 (95 % CI 0.93-7.15) and aOR 0.93 (95 % CI 0.48-1.83), respectively. CONCLUSIONS: Women with MS having disease activity during pregnancy did not have a statistically significantly increased risk of adverse neonatal outcomes compared to women with MS without disease activity, which is overall reassuring results. We believe, that this will be useful knowledge for patients and clinicians in planning a pregnancy and preparing a birth plan.

Social factors and age play a significant role in cervical cancer and advanced-stage disease among Danish women.

BACKGROUND: For cervical cancer (CC), the implementation of preventive strategies has the potential to make cervical cancer occurrence and death largely avoidable. To better understand the factors possibly responsible for cervical cancer, we aimed to examine possible differences in age and social parameters as well as screening status between women with low- or high-stage cervical cancer and matched controls. METHODS: Through the Danish Cancer Registry (DCR), women diagnosed with cervical cancer in Denmark between 1987 and 2016 were included. These were age- and residence-matched in a 1:5 ratio with controls from the general female population. The study population was sub grouped into a low-stage subpopulation with women with early-stage cervical cancer and matched controls and a high-stage subpopulation with women with late-stage cervical cancer and matched controls. Age and social parameters were compared within the subpopulations as well as between low- and high-stage cases. For part of the study population, screening attendance was examined to compare differences in adherence. RESULTS: Overall, we found that the risk of cervical cancer is significantly increased in socially disadvantaged women and not least non-attenders in screening. Interestingly, the high-stage subpopulation was significantly older than the low-stage subpopulation (p < 0.001), and when examining the impact of age further, we found that for cervical cancer cases, the risk of having low-stage disease decreases significantly with increasing age, whereas the risk of having high-stage disease increases significantly with increasing age. In the screening cohort, significantly less cases than controls were attenders in screening with the most pronounced differences seen in the old subpopulation (women aged 50-64 years) and in the high-stage subpopulation (p-values all < 0.001). Interestingly, when examining the risk of CC for attenders and non-attenders, we demonstrated that many social parameters continue to influence the risk of cervical cancer, even in women attending screening. CONCLUSIONS: Older women, socially disadvantaged women, and non-attenders in screening are particularly vulnerable in terms of developing cervical cancer, especially high-stage disease. Therefore, improvements in the participating rate in screening as well as a revision of the current screening guidelines are needed.

Nurse navigation, symptom monitoring and exercise in vulnerable patients with lung cancer: feasibility of the NAVIGATE intervention.

We developed the Navigate intervention to improve survival among vulnerable lung cancer patients. In this intervention-only study, we examined feasibility in terms of recruitment, retention, attendance, adherence, and acceptability to specify adjustments to study procedures and intervention components prior to a randomized trial. The Navigate intervention includes nurse navigation, patient-reported outcomes, and physical exercise. Patients ≥ 18 years old, diagnosed with non-small cell lung cancer at any stage, with performance status ≤ 2, eligible for cancer treatment and vulnerable according to a screening instrument were included. The recruitment goal of eligible patients was 40% while the retention goal was 85%. The predefined cut-offs for sufficient attendance and adherence were ≥ 75%. Acceptability was evaluated by semi-structured interviews with participants, nurse navigators, and physiotherapists. Seventeen (56%) out of 30 screened patients were considered vulnerable and eligible for the study, 14 (82%) accepted participation, and 3 (21%) were subsequently excluded due to ineligibility, leaving 11 patients. Four patients dropped out (36%) and four patients died (36%) during follow-up and 3 (27%) were retained. All 11 patients participated in nurse sessions (mean 16, range 1-36) with 88% attendance and dialogue tools being applied in 68% of sessions. Ninety-one percent of patients responded to PROs (mean of 9 PROs, range 1-24) with 76% of the PRO questionnaires used (attendance) and 100% adherence (completion of all questions in PRO questionnaires), and 55% participated in exercise sessions with 58% attendance and 85% adherence. We identified important barriers primarily related to transportation, but overall acceptability was high. The Navigate intervention was feasible with high participation, acceptability and satisfactory adherence. Retention and exercise attendance were low, which resulted in adjustments.Trial registration: The feasibility study was initiated prior to the multicenter randomized controlled trial registered by ClinicalTrials.gov (number: NCT05053997; date 23/09/2021).

Effects of Demographic and Socio-Economic Factors on Investigation Time of Lung Cancer Patients in Denmark: A Retrospective Cohort Study.

Background: Lung cancer is one of the most common cancer types worldwide. The significance of the individual socio-economic position on the delay in lung cancer diagnosis has not been properly investigated. The purpose of this nationwide population-based study is to examine the association between position and the length of the primary investigation for lung cancer. Materials and Methods: This register study was based on all lung cancer patients in Denmark who were diagnosed in 2012 to 2017, in total 28,431 patients. We used a multivariate logistic regression model and multivariate zero-inflated negative binomial model to estimate the effect of education level, family income, difficulty of transport, and cohabitation status on the length of the primary investigation. Results: We found that the patients' income, difficulty of transport, and cohabitation status were associated with the length of the primary investigation. The chance of carrying out the investigation process within 24 days is higher for patients with a high income (adjusted OR = 0.86 with 95% CI (0.81; 0.91)), lower for patients with troublesome transport (adjusted OR = 0.67 with 95% CI (0.61; 0.72)), and lower for patients living alone (adjusted OR = 0.93 with 95% CI (0.88; 0.99)). Conclusion: Several socio-economic factors are associated with the length of the primary lung cancer investigation. To ensure that all patients receive the most appropriate health care and to avoid extra investigation time, clinicians may pay extra attention to patients who are less fortunate due to low income, troublesome transport to the hospital, or living alone.

Who are the vulnerable lung cancer patients at risk for not receiving first-line curative or palliative treatment?

BACKGROUND: To identify non-small-cell lung cancer (NSCLC) patients in need of comprehensive support, we examined the association between patient and disease-related factors of vulnerability related to not receiving guideline-recommended treatment. MATERIAL AND METHODS: We identified 14,597 non-small-cell lung cancer (NSCLC) patients with performance status <3 during 2013-2018 in the Danish Lung Cancer Registry. Multivariate logistic regression models were used to estimate Odds Ratios (ORs) and 95% confidence intervals (CIs) for receiving guideline-recommended treatment according to stage, comorbidities, age, performance status, long distance to hospital, cohabitation status, education and alcohol abuse. RESULTS: 21% of stage I-IIIA NSCLC patients did not receive curative treatment while 10% with stage IIIB-IV did not receive any oncological therapy. Factors associated with reduced likelihood of receiving curative treatment included: advanced stage (OR = 0.45; 95% CI = 0.42-0.49), somatic comorbidity (OR = 0.72; 95% CI = 0.63-0.83), age ≥ 80 years (OR = 0.59; 95% CI = 0.55-0.64), performance status = 2 (OR = 0.33; 95% CI = 0.28-0.39) and living alone (OR = 0.79; 95% CI = 0.69-0.90). Results were similar for stage IIIB-IV NSCLC patients, although a statistically significant association was also seen for long distances to the hospital (OR = 0.71; 95% CI = 0.58-0.86). CONCLUSIONS: Several factors are associated with not receiving guideline-recommended NSCLC treatment with age, performance status, comorbidity and stage being most predictive of no treatment receipt. Efforts should be made to develop support for vulnerable lung cancer patients to improve adherence to optimal first-line therapy.

Causes of Patient Nonattendance at Medical Appointments: Protocol for a Mixed Methods Study.

BACKGROUND: Approximately one-third of patient appointments in Danish health care result in failures, leading to patient risk and sizable resource waste. Existing interventions to alleviate no-shows often target the patients. The underlying reason behind these interventions is a view that attendance or nonattendance is solely the patient's problem. However, these interventions often prove to be ineffective and can perpetuate social biases and health inequalities, leaving behind patients who are more vulnerable or disadvantaged (in terms of social, economical, and linguistic factors, etc). A more holistic understanding of no-shows is needed to optimize processes, reduce waste, and support patients who are vulnerable. OBJECTIVE: This study aims to gain a deep and more comprehensive understanding of the causes, mechanisms, and recurring patterns and elements contributing to nonattendance at Danish hospitals in the Region of Southern Denmark. It emphasizes the patient perspective and analyzes the relational and organizational processes surrounding no-shows in health care. In addition, the study aims to identify effective communicative strategies and organizational processes that can support the development and implementation of successful interventions. METHODS: The study uses mixed quantitative-qualitative methods, encompassing 4 analytical projects focusing on nonattendance patterns, patient knowledge and behavior, the management of hospital appointments, and in situ communication. To address the complexity of no-shows in health care, the study incorporates various data sources. The quantitative data sources include the electronic patient records, Danish central registries, Danish National Patient Registry, and Register of Medicinal Product Statistics. Baseline characteristics of patients at different levels are compared using chi-square tests and Kruskal-Wallis tests. The qualitative studies involve observational data, individual semistructured interviews with patients and practitioners, and video recordings of patient consultations. RESULTS: This paper presents the protocol of the study, which was funded by the Novo Nordisk Foundation in July 2022. Recruitment started in February 2023. It is anticipated that the quantitative data analysis will be completed by the end of September 2023, with the qualitative investigation starting in October 2023. The first study findings are anticipated to be available by the end of 2024. CONCLUSIONS: The existing studies of nonattendance in Danish health care are inadequate in addressing relational and organizational factors leading to hospital no-shows. Interventions have had limited effect, highlighting the Danish health care system's failure to accommodate patients who are vulnerable. Effective interventions require a qualitative approach and robust ethnographic data to supplement the description and categorization of no-shows at hospitals. Obtaining comprehensive knowledge about the causes of missed patient appointments will yield practical benefits, enhancing the safety, coherence, and quality of treatment in health care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46227.

Psychiatric disorders, diagnosed in psychiatric clinics, in patients with back pain: A cohort study.

Aims: The aim of this study was to evaluate whether patients with a non-specific back pain disorder are more likely to be diagnosed with a psychiatric disorder than patients with a specific back pain disorder (such as a herniated disc or inflammatory back disorder). Methods: This was a retrospective cohort study using Danish registries. Results: Our study population included 24,518 patients younger than 61 years and 12,274 patients older than 61 years. In both subpopulations, 60% had a non-specific back pain diagnosis (BPD). In the younger subpopulation, 2.1% of the patients with a non-specific BPD and 1.3% of the patients with a specific BPD had a psychiatric diagnosis within one year of their BPD. In the older subpopulation, 0.6% of patients had a psychiatric diagnosis in both BPD groups. The most frequent psychiatric diagnoses were stress-related disorders. In the younger subpopulation, patients with non-specific back pain had a higher risk of being diagnosed with a psychiatric disorder than patients with specific back pain (adjusted odds ratio 1.56, 95% confidence interval 1.25-1.94). The type of BPD had no effect on the risk of having a psychiatric diagnosis among older patients. Conclusions: Patients with a non-specific back pain disorder younger than 61 years were more likely to be diagnosed with a psychiatric disorder than patients with a specific back pain disorder. We recommend that spine specialists pay special attention to patients younger than 61 years with a back pain disorder to prevent them from developing a psychiatric disorder.

NAVIGATE: improving survival in vulnerable patients with lung cancer through nurse navigation, symptom monitoring and exercise - study protocol for a multicentre randomised controlled trial.

INTRODUCTION AND AIM: Low socioeconomic position (SEP) has been shown to be strongly associated with impaired lung cancer survival. Barriers related to receiving recommended treatment among patients with lung cancer with low SEP may include adverse health behaviour and limited physical and psychosocial resources influencing the ability to react on high-risk symptoms and to navigate the healthcare system. To address the underlying factors that drive both decisions of treatment, adherence to treatment and follow-up in vulnerable patients with lung cancer, we developed the Navigate intervention. The aim of this randomised controlled trial is to investigate the effect of the intervention on survival (primary outcome), lung cancer treatment adherence, health-related quality of life and other psychosocial outcomes as well as health costs and process evaluation (secondary outcomes) in a study population of vulnerable patients with lung cancer. METHODS AND ANALYSIS: This two-armed multicentre randomised trial will recruit patients from five lung cancer clinics in Denmark identified as vulnerable according to a screening instrument with nine clinical and patient-reported vulnerability criteria developed for the study. We will enrol 518 vulnerable patients >18 years old diagnosed with non-small cell lung cancer at all stages with a performance status <2. Participants will be randomly allocated to either standard treatment and intervention or standard treatment alone. The Navigate intervention is based on principles from motivational interviewing and includes three components of nurse navigation, systematic monitoring of patient-reported outcomes (PROs) and physical exercise in a person-centred delivery model. Data will be collected at baseline and 3, 6, 12 months after randomisation using questionnaires, clinical data and physical function tests. ETHICS AND DISSEMINATION: Ethics Committee, Region Zealand (SJ-884/EMN-2020-37380) and the Data Protection Agency in Region Zealand (REG-080-2021) approved the trial. Participants will provide written informed consent. Results will be reported in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05053997.

Impact of C-reactive protein and albumin levels on short, medium, and long term mortality in patients with diffuse large B-cell lymphoma.

Objectives and study design: In this population-based study of 602 patients, we amended C-reactive protein (CRP) and plasma albumin (PA) levels around the diagnosis of diffuse large B-cell lymphoma (DLBCL) to the International Prognostic Index (IPI) and assessed 0-90, 91-365, and +365-day survival.Results: The CRP did not contribute to the IPI's prognostic or discriminatory ability, regardless of time period, particularly not in models with PA. In contrast, the PA was an important contributor, especially in the 0-90 day period, but also up to one year after the diagnosis. For day 0-90, the model with the IPI only had an Area Under the Receiver Operating Characteristics (AUROC) of 0.742, whereas the IPI with PA as a continuous variable rendered an AUROC of 0.841. Especially the lower PA quartile (18-32 g/L) contributed to the worse prognosis.Conclusions: The amendment of PA to the IPI may significantly improve the short-term prognostic and discriminative ability.Key messagesThe amendment of the plasma albumin (PA) level to the International Prognostic Index significantly improved the prediction of mortality up to one year after the diagnosis of diffuse large B-cell lymphoma.It was especially the lower quartile of the PA level (18-32 g/L) that contributed to the worse prognosis.

The clinical back pain courses described by information available in Danish central registries.

BACKGROUND: Patients with back pain are often in contact with 2-4 hospital departments when receiving a back pain diagnosis and treatment. This complicates the entire clinical course description. There is, currently, no model that describes the course across departments for patients with back pain. This study aims to construct an interdisciplinary clinical course using the central register's information. METHODS: All patients with back pain referred for diagnosis and treatment at the Spine Center of Southern Denmark from 1 January 2011 until 31 December 2017 were included. By means of information available in central registers, we described the interdisciplinary clinical course for the individual patient, including information on all contacts at different departments, and proposed three different models to define the index and final date. The index date was defined as the first visit without a previous contact to the Spine Center for 6 months for model I, 1 year for model II, and 2 years for model III. The final date was defined as the last visit without following contacts for 6 months, 1 year, and 2 years, respectively, for models I, II, and III. RESULTS: A total of 69,564 patients (male: n = 30,976) with back pain diagnosis were identified. The three models all leave the information on the entire course at the hospital. In model I (64,757 clinical back pain courses), the time span to a possible previous clinical course is too short to secure the start of a new course (14% had two or more). With at least 1 year between a possible previous contact, model II (60,914 courses) fits the everyday clinical practice (9% had two or more clinical back pain courses). In model III (60,173 courses) it seems that two independent courses might be connected in the same course as only 5% had two or more clinical back pain courses. CONCLUSIONS: Despite contact with different departments, the clinical course for back pain patients can be described by information from the central registers. A one-year time interval fits best the clinicians' everyday observations.

Association between head and neck cancer and sexually transmitted diseases: a Danish nationwide, case-control study.

Background: An association between sexually transmitted diseases (STDs) and occurrence of head and neck cancer (HNC) is proposed.Aims/objectives: We aimed to determine the association between selected STDs (syphilis, gonorrhoea, HIV) and HNC.Materials and methods: Patients diagnosed with HNC in Denmark between 1978 and 2014 identified through the Danish Cancer Registry were included. Patients were age- and sex-matched in a 1:10 ratio with general population controls. Uni- and multivariate analyses were performed using the Cox regression model to assess the correlation between STD and HNC.Results: A total of 39,405 HNC patients (63% men; 63.0 years at HNC diagnosis) and 393,238 controls were included. STD in HNC patients was 0.27%, vs. 0.11% in controls. Patients with cancer of the upper airways had a significantly higher prevalence of an STD prior to the HNC compared to controls. Most HNC patients with a prior STD (64.1%) developed the HNC within five years after the STD diagnosis.Conclusions: Although the studied STDs are rare, patients with cancer of the upper aerodigestive tract more commonly had a previous diagnosis of STD compared to controls. The study promotes the hypothesis that a causal link exists between STD and HNC.

Patient reported outcome data as performance indicators in surgically treated lung cancer patients.

OBJECTIVE: Quality in lung cancer care is in Denmark routinely evaluated using quality indicators. The indicators are reported from national registries and are based on data from health care professionals. However, data based on the patients' perspective are rarely reported. The aim of this study was to propose a model for the use of patient reported outcomes (PROs) as quality indicators, enabling us to compare PROs across the surgical departments in Denmark. METHODS: All patients registered in the Danish Lung Cancer Registry (DLCR) from 1 October 2013 until 30 September 2015 who received surgical treatment were eligible (N = 1718). They were asked to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire six months after surgery. From QLQ-C30 we chose global health status (GHS) and role function (RF) as indicators to be tested. An indicator threshold for good performance was set to ≥ 65 points (on a scale 0-100 where 100 was the best). Results were compared between the four thoracic surgical departments in Denmark. RESULTS: Of 1615 patients alive six months after surgery, questionnaires were completed by 1002 patients (62.0%). The patients from the four departments differed significantly in clinical variables at diagnosis, and the departments differed significantly in the surgical procedures performed. After adjustment for case-mix, the patients in Department 2 had a better RF than patients from the other departments. CONCLUSION: Significant differences in RF and in the fulfilment of the indicator requirement for RF were observed. Since these findings might indicate differences in the quality of performance between participating departments, subsequent audit is recommended. The analyses and results indicate that it is feasible to use PROs as supplementary outcome indicators in the evaluation of the quality of surgical treatment for lung cancer. Our model could serve as a useful foundation for further research.

Nationwide Introduction of Minimally Invasive Robotic Surgery for Early-Stage Endometrial Cancer and Its Association With Severe Complications.

Importance: Minimally invasive laparoscopic surgery (MILS) for endometrial cancer reduces surgical morbidity compared with a total abdominal hysterectomy. However, only a minority of women with early-stage endometrial cancer undergo MILS. Objective: To evaluate the association between the Danish nationwide introduction of minimally invasive robotic surgery (MIRS) and severe complications in patients with early-stage endometrial cancer. Design, Setting, and Participants: In this nationwide prospective cohort study of 5654 women with early-stage endometrial cancer who had undergone surgery during the period from January 1, 2005, to June 30, 2015, data from the Danish Gynecological Cancer Database were linked with national registers on socioeconomic status, deaths, hospital diagnoses, and hospital treatments. The women were divided into 2 groups; group 1 underwent surgery before the introduction of MIRS in their region, and group 2 underwent surgery after the introduction of MIRS. Women with an unknown disease stage, an unknown association with MIRS implementation, unknown histologic findings, sarcoma, or synchronous cancer were excluded, as were women who underwent vaginal or an unknown surgical type of hysterectomy. Statistical analysis was conducted from February 2, 2017, to May 4, 2018. Exposure: Minimally invasive robotic surgery, MILS, or total abdominal hysterectomy. Main Outcomes and Measures: Severe complications were dichotomized and encompassed death within 30 days after surgery and intraoperative and postoperative complications diagnosed within 90 days after surgery. Results: A total of 3091 women (mean [SD] age, 67 [10] years) were allocated to group 1, and a total of 2563 women (mean [SD] age, 68 [10] years) were allocated to group 2. In multivariate logistic regression analyses, the odds of severe complications were significantly higher in group 1 than in group 2 (odds ratio [OR], 1.39; 95% CI, 1.11-1.74). The proportion of women undergoing MILS was 14.1% (n = 436) in group 1 and 22.2% in group 2 (n = 569). The proportion of women undergoing MIRS in group 2 was 50.0% (n = 1282). In group 2, multivariate logistic regression analyses demonstrated that a total abdominal hysterectomy was associated with increased odds of severe complications compared with MILS (OR, 2.58; 95% CI, 1.80-3.70) and MIRS (OR, 3.87; 95% CI, 2.52-5.93). No difference was found for MILS compared with MIRS (OR, 1.50; 95% CI, 0.99-2.27). Conclusions and Relevance: The national introduction of MIRS changed the surgical approach for early-stage endometrial cancer from open surgery to minimally invasive surgery. This change in surgical approach was associated with a significantly reduced risk of severe complications.

Patient-reported outcomes (PROs) in lung cancer: Experiences from a nationwide feasibility study.

OBJECTIVES: Our objectives were to examine the feasibility of a nationwide collection of patient-reported outcomes (PROs) in a lung cancer population as well as in various sub-populations, and to describe the characteristics of responders compared to non-responders. MATERIALS AND METHODS: All patients diagnosed with lung cancer in Denmark are registered in the Danish Lung Cancer Registry (DLCR). The 7,295 patients registered in DLCR from 1 October 2013 until 30 September 2015 who had received treatment were eligible. Using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-LC13 questionnaires, we employed two different methods of delivery, resulting in two different project parts. In project part 1, the baseline questionnaire was handed out at the hospital departments before treatment. The following questionnaires were sent out as paper versions three times within one year. In project part 2, all questionnaires were electronic versions delivered in association with planned hospital visits. RESULTS: Of the 7,295 lung cancer patients 4,229 (58%) completed at least one questionnaire, and 2,459 completed two or more. Only 562 baseline questionnaires were returned before treatment (7.7%), whereas 43.4%-57.4% of the potential responders completed the following questionnaires. The best response rates were achieved among patients treated with surgery and among patients who discussed their questionnaires with health care personnel. When comparing patient characteristics, responders had a significantly better health and a higher socioeconomic position than non-responders. CONCLUSION: A decentralised model used for delivering the initial questionnaire to the patients was insufficient. It is our estimation that sending out electronic versions of the baseline questionnaires, as was done with the following questionnaires, would result in a significantly better patient coverage. Despite the severe morbidity and high mortality rate in lung cancer, reasonable response rates were achieved at follow-ups to this method, and PRO collection in this population was feasible.

Colon cancer patients with a serious psychiatric disorder present with a more advanced cancer stage and receive less adjuvant chemotherapy - A Nationwide Danish Cohort Study.

BACKGROUND: Psychiatric patients with colorectal cancer may have delayed diagnosis and be oncologically undertreated. METHODS: The Danish Colorectal Cancer Group database comprised 25,194 colorectal cancer patients (CRC), (colon cancer (CC, n = 16,641), rectal cancer (RC, n = 8553)), having an operation in 2007-2013, were alive at least 30 days after operation, of which 422 have had at least one hospital contact for a serious psychiatric disorder; ICD-10: DF20-29: primary psychotic disorders, or DF30-39: affective disorders (exposed) in a period of 3650-120 days before the operation date. Pearson chi-squared test for cancer stage was calculated. Odds Ratio (OR) with 95% confidence interval (CI) for having had a palliative vs an intended curative aim of the operative treatment for CRC patients (cohort 1), and for having an oncological treatment for each cancer site CC or RC (cohort 2 and 3) in patients with and without a psychiatric history was estimated. We adjusted the OR for: age, gender, comorbidity index, cancer stage, socio-economic position group, and educational level. RESULTS: A higher cancer stage at the time of operation in patients with psychiatric disorders compared with patients without such a history was seen and may possibly point towards a delay in the diagnosis or in the treatment of CC in patients with psychiatric disorders. They also had decreased adjusted OR for having an oncological treatment, OR 0.55, 95% CI (0.40-0.76)), which was not explained by cancer stage. For patients with RC no difference was seen. CONCLUSIONS: Attention for CC patients with pre-existing serious psychiatric disorders is recommended.

Transfer between hospitals as a predictor of delay in diagnosis and treatment of patients with Non-Small Cell Lung Cancer - a register based cohort-study.

BACKGROUND: Lung cancer is the second most frequent cancer diagnosis in Denmark. Although improved during the last decade, the prognosis of lung cancer is still poor with an overall 5-year survival rate of approximately 12%. Delay in diagnosis and treatment of lung cancer has been suggested as a potential cause of the poor prognosis and as consequence, fast track cancer care pathways were implemented describing maximum acceptable time thresholds from referral to treatment. In Denmark, patients with lung cancer are often transferred between hospitals with diagnostic facilities to hospitals with treatment facilities during the care pathway. We wanted to investigate whether this organizational set-up influenced the time that patients wait for the diagnosis and treatment. Therefore, the objective of this study was to uncover the impact of transfer between hospitals on the delay in the diagnosis and treatment of Non-Small Cell Lung Cancer (NSCLC). METHODS: We performed a historical prospective cohort study using data from the Danish Lung Cancer Registry (DLCR). All patients diagnosed with primary NSCLC from January 1st 2008 to December 31st 2012 were included. Patients with unresolved pathology and incomplete data on the dates of referral, diagnosis and treatment were excluded. RESULTS: A total of 11 273 patients were included for further analyses. Transfer patients waited longer for treatment after the diagnosis, (Hazard ratio (HR) 0.81 (0.68-0.96)) and in total time from referral to treatment (HR 0.84 (0.77-0.92)), than no-transfer patients. Transfer patients had lower odds of being diagnosed (Odds Ratio (OR) 0.82 (0.74-0.94) and treated (OR 0.66 (0.61-0.72) within the acceptable time thresholds described in the care pathway. CONCLUSION: Fast track cancer care pathways were implemented to unify and accelerate the diagnosis and treatment of cancer. We found that the transfer between hospitals during the care pathway might cause delay from diagnosis to treatment as well as in the total time from referral to treatment in patients with Non Small-Cell Lung Cancer. The difference between no-transfer and transfer patients persists after adjusting for known predictors of delay.

Detection of recurrence in early stage endometrial cancer - the role of symptoms and routine follow-up.

BACKGROUND: Considerable controversy remains as to the optimal organization of endometrial cancer follow-up. AIM: To evaluate the relationship between the way recurrence was detected and survival after treatment for endometrial cancer. Further, to identify characteristics associated with a pre-scheduled examination in women with symptomatic recurrence. MATERIAL AND METHODS: All women with early stage endometrial cancer during 2005-2009 were included in a population-based historical cohort derived from the Danish Gynecological Cancer Database. Women diagnosed with recurrence within three years after primary surgery and the mode of recurrence detection were identified from hospital charts: asymptomatic recurrence detected at regular follow-up, symptomatic recurrence detected at regular follow-up or symptomatic recurrence detected in between follow-up. Survival of women with symptomatic and asymptomatic disease was compared. Furthermore, characteristics associated with self-referral as compared to presenting symptoms at regular follow-ups were identified using univariate analyses. RESULTS: In total, 183 cases of recurrence (7%) were identified in the cohort of 2612 women. Of these, 65.5% were symptomatic with vaginal bleeding as the most prevalent symptom. Asymptomatic women had a significantly better three-year survival rate compared to symptomatic women (80.3% vs. 54.3%, p < 0.01). A total of 2.3% of the entire population had an asymptomatic recurrence. Women diagnosed at a pre-scheduled visit due to symptoms had a higher educational level (p = 0.03) and more often high-risk disease (p = 0.02) than symptomatic women diagnosed at regular follow-up. CONCLUSION: Early stage endometrial cancer carries a low risk of recurrence. Survival appears to be superior in asymptomatic patients, but length-time bias, i.e. the effect of aggressive tumor biology in symptomatic recurrences, may bias results in non-randomized controlled trials. Well educated patients with symptoms of recurrence more often sought medical attendance compared to less educated counterparts. This should be considered if patient-initiated follow-up is the standard care.

The nature of early-stage endometrial cancer recurrence-A national cohort study.

BACKGROUND AND AIMS: The aim of the study was to present a comprehensive analysis of disease recurrence in a large Danish cohort of women with early-stage endometrial cancer treated according to national guidelines. METHODS: All women diagnosed with stage I or II endometrial cancer in 2005-2009 were included in a population-based historical cohort derived from the Danish Gynaecological Cancer Database. Disease recurrence up to 3 years after the primary diagnosis was identified using national registers and hospital charts. Follow-up on survival ended on 31st December 2014. We evaluated the predictive value of clinico-pathological and sociodemographic variables using multivariate logistic regression. RESULTS: Recurrence within 3 years of the primary treatment was diagnosed in 183 (7%) of the included 2612 women. Site of recurrence significantly impacted on overall survival as the 5-year survival rate was 64.8% for women with vaginal recurrence and 17.5% in women with distant recurrence. Factors predictive of recurrence included the International Federation of Gynaecology and Obstetrics (FIGO) stage (OR: IB = 1.91, stage II = 3.91), Charlson comorbidity index of 3 (OR 1.86), non-endometrioid histology (OR 1.81) and being outside of the workforce (OR 1.81). Vaginal recurrence was predicted by FIGO stage only (OR: IB = 1.88, II = 2.79), while extra-vaginal recurrence was predicted by FIGO stage (OR: IB = 2.12, II = 3.31), Charlson comorbidity index of 3 (OR 1.88) and non-endometrioid histology (OR 2.51). CONCLUSIONS: Future research should seek to understand the underlying mechanisms of the identified predictive factors to improve recurrence prediction and to reduce morbidity and mortality.

Predictors of mortality within 1 year after primary ovarian cancer surgery: a nationwide cohort study.

OBJECTIVES: To identify predictors of mortality within 1 year after primary surgery for ovarian cancer. DESIGN: Prospective nationwide cohort study from 1 January 2005 to 31 December 2012. SETTING: Evaluation of data from the Danish Gynaecology Cancer Database and the Danish Civil Registration System. PARTICIPANTS: 2654 women who underwent surgery due to a diagnosis of primary ovarian cancer. OUTCOME MEASURES: Overall survival and predictors of mortality within 0-180 and 181-360 days after the primary surgery. Examined predictors were age, preoperative American Society of Anesthesiologists (ASA) score, body mass index (BMI), International Federation of Gynaecology and Obstetrics (FIGO) stage, residual tumour tissue after surgery, perioperative blood transfusion and calendar year of surgery. RESULTS: The overall 1-year survival was 84%. Within 0-180 days after surgery, the 3 most important predictors of mortality from the multivariable model were residual tumour tissue >2 cm versus no residual tumour (HR=4.58 (95% CI 3.20 to 6.59)), residual tumour tissue ≤2 cm versus no residual tumour (HR=2.50 (95% CI 1.63 to 3.82)) and age >64 years versus age ≤64 years (HR=2.33 (95% CI 1.69 to 3.21)). Within 181-360 days after surgery, FIGO stages III-IV versus I-II (HR=2.81 (95% CI 1.75 to 4.50)), BMI<18.5 vs 18.5-25 kg/m(2) (HR=2.08 (95% CI 1.18 to 3.66)) and residual tumour tissue >2 cm versus no residual tumour (HR=1.84 (95% CI 1.25 to 2.70)) were the 3 most important predictors. CONCLUSIONS: The most important predictors of mortality within 1 year after surgery were residual tumour tissue (0-180 days after surgery) and advanced FIGO stage (181-360 days after surgery). However, our results suggest that the surgeon should not just aim at radical surgery, but also pay special attention to comorbidity, nutritional state, age >64 years and the need for perioperative blood transfusion.