IntroductionShared decision making (SDM) has become a crucial element on the political agenda and represents a vital aspect of modern healthcare. However, successful implementation of SDM highly depends on the attitude of clinicians towards SDM. The overall aim of our study was to explore the experience of oncologists and nurses with SDM using the Decision Helper, an in-consultation decision aid, at four Danish radiotherapy departments.MethodsSemi-structured interviews were conducted with 20 clinicians. The participants were selected using purposive sampling to include nurses and oncologists, male and female, with different levels of experience with SDM and clinical work. The analysis was a data-driven, iterative process with inductive coding of all interviews and meaning condensation.ResultsTwo main themes emerged: “Using the Decision Helper changes the consultation” and “Change of attitude among Danish oncologists”. Each of the two themes included four elaborative subthemes, which are reported with supporting citations in this paper. In brief, the use of SDM and the Decision Helper should ideally be adjusted to the individual patient and depends highly on the oncologist. The participants described ambitions towards "making the right decision for this patient at this time”. The healthcare system, however, has pitfalls that may hinder SDM, e.g. rigid interpretation of guideline-based recommendations.ConclusionUsing an in-consultation Decision Helper has the potential for individualized, structured patient engagement in decision making. There is a need for patient decision aids in clinical guidelines to ensure patient engagement in decision making.Micro AbstractClinicians’ experience of shared decision making and their use of patient decision aids are crucial for the implementation of shared decision making. Fourteen oncologists and six nurses share their experiences in this paper. Overall, while our findings indicate that the use of an in-consultation patient decision aid (the Decision Helper) requires a change in their practice, the clinicians report that using decision aids has the potential for individualized, structured patient involvement in decision making.

Background After curative surgery for early-stage breast cancer, patients face a decision on whether to undergo surgery alone or to receive one or more adjuvant treatments, which may lower the risk of recurrence. Variations in survival outcomes are often marginal but there are differences in the side effects and other features of the options that patients may value differently. Hence, the patient’s values and preferences are critical in determining what option to choose. It is well-researched that the use of shared decision making and patient decision aids can support this choice in a discussion between patient and clinician. However, it is still to be investigated what impact the timing and format of the patient decision aid have on shared decision making outcomes. In this trial, we aim to investigate the impact of a digital pre-consult compared to a paper-based in-consult patient decision aid on patients’ involvement in shared decision making, decisional conflict and preparedness to make a decision. Methods The study is a randomised controlled trial with 204 patients at two Danish oncology outpatient clinics. Eligible patients are newly diagnosed with early-stage breast cancer and offered adjuvant treatments after curative surgery to lower the risk of recurrence. Participants will be randomised to receive either an in-consult paper-based patient decision aid or a pre-consult digital patient decision aid. Data collection includes patient and clinician-reported outcomes as well as observer-reported shared decision making based on audio recordings of the consultation. The primary outcome is the extent to which patients are engaged in a shared decision making process reported by the patient. Secondary aims include the length of consultation, preparation for decision making, preferred role in shared decision making and decisional conflict. Discussion This study is the first known randomised, controlled trial comparing a digital, pre-consult patient decision aid to an identical paper-based, in-consult patient decision aid. It will contribute evidence on the impact of patient decision aids in terms of investigating if pre-consult digital patient decisions aids compared to in-consult paper-based decision aids support the cancer patients in being better prepared for decision making. Trial registration ClinicalTrials.gov (NCT05573022).

Background and purposeShared decision making (SDM) is a patient engaging process advocated especially for preference-sensitive decisions, such as adjuvant treatment after breast cancer. An increasing call for patient engagement in decision making highlights the need for a systematic SDM approach. The objective of this trial was to investigate whether the Decision Helper (DH), an in-consultation patient decision aid, increases patient engagement in decisions regarding adjuvant whole breast irradiation.Material and methodsOncologists at four radiotherapy units were randomized to practice SDM using the DH versus usual practice. Patient candidates for adjuvant whole breast irradiation after breast conserving surgery for node-negative breast cancer were eligible. The primary endpoint was patient-reported engagement in the decision process assessed with the Shared Decision Making Questionnaire (SDM-Q-9) (range 0-100, 4 points difference considered clinical relevant). Other endpoints included oncologist-reported patient engagement, decisional conflict, fear of cancer recurrence, and decision regret after 6 months.ResultsOf the 674 included patients, 635 (94.2%) completed the SDM-Q-9. Patients in the intervention group reported higher level of engagement (median 80; IQR 68.9 to 94.4) than the control group (71.1; IQR 55.6 to 82.2; p< 0.0001). Oncologist-reported patient engagement was higher in the invention group (93.3; IQR 82.2 to 100) compared to control group (73.3; IQR 60.0 to 84.4) (p < 0.0001).ConclusionPatient engagement in medical decision making was significantly improved with the use of an in-consultation patient decision aid compared to standard. The DH on adjuvant whole breast irradiation is now recommended as standard of care in the Danish guideline.

Objectives Treosulfan is offered as last-line treatment in patients with end-stage ovarian cancer. This retrospective study aimed to evaluate the response rates, overall survival, and adverse events of treosulfan in this patient population. Methods The study included patients with end-stage platinum-resistant ovarian cancer treated with treosulfan from October 2015 to October 2020 at the Department of Oncology, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark. Patients were included for treatment if their cancer had progressed and if other treatment options were limited. Patients receiving treosulfan as first-line treatment were excluded from the study. Response rates were evaluated according to the combined criteria of CA125 and Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Kaplan-Meier survival analyses were used to illustrate progression-free and overall survival. Adverse events were graded 1-5 according to the Common Terminology Criteria for Adverse Events version 5.0. Results Sixty-seven patients with a median age of 72 years (range 33-92) were identified. Sixty-three (94%) patients were diagnosed with serous adenocarcinoma. Fifty-seven (85%) patients were Federation of International Gynecology and Obstetrics (FIGO) stage III or IV at the time of diagnosis. The median number of treatments prior to treosulfan treatment was 3 (range 1-8). One patient had a complete response (2%), eight patients had a partial response (13%), and 22 patients (35%) had stable disease as the best response. The median duration of response (complete or partial) was 239 days (range 43-572). Median progression-free survival was 63 days (95% CI 41 to 77). The most common adverse events were anemia (83%), fatigue (83%), anorexia (62%), nausea (57%), and constipation (41%). Conclusions Treosulfan is an alternative for the treatment of relapsed ovarian cancer when other treatment options are limited, with response rates of approximately 15%. In general, the treatment was well tolerated. Taking the mild adverse events and the response rates into account, palliative treosulfan mainly seems beneficial for patients with performance status 0-1.

Shared decision making (SDM) is on the international healthcare agenda among patient advocacy groups and decision makers in healthcare worldwide [1–5]. In Denmark, implementation of SDM with all ca...

Objective: Concerns of increased time consumption and of the impact on clinical decisions may restrain doctors from shared decision making (SDM). This paper evaluates consultation length and decisions made when using an in-consult patient decision aid (PtDA). Methods: This prospective cohort study compared an unexposed cohort with a cohort exposed to SDM and a PtDA in two preference-sensitive decision situations: invasive lung cancer diagnostics and adjuvant treatment for early breast cancer. Outcome measures were consultation length and decisions made. Results: The study included 261 consultations, 115 were in the SDM-exposed cohort. Consultations were inconsiderably longer in the SDM cohort; 2 min, 11 s (p = 0.2217) for lung cancer diagnostics and 3 min, 57 s (p = 0.1128) for adjuvant breast cancer treatment. In lung cancer diagnostics, consultation length became more uniform and decisions tended to become conservative after introduction of SDM. For adjuvant breast cancer, slightly more patients in the SDM cohort chose to decline treatment. Conclusion: Shared decision making did not take significantly longer time and led to slightly more conservative decisions. Practice implications: SDM may be implemented without considerable impact on consultation length. The impact on clinical decisions depends mainly on the clinical situation. (c) 2020 Elsevier B.V. All rights reserved.

Abstract Background and aims Almost 20% of the adult population suffers from chronic pain. Chronic pain may be linked to an elevated mortality; however, results from previous studies are inconsistent. Some studies find similar mortality levels in chronic pain patients and pain-free controls while other studies show elevated mortality levels among chronic pain patients, primarily with respect to cancer, diseases of the circulatory and respiratory systems, and suicide. These conflicting results are potentially due to different population samples and different operational definitions of chronic pain. Further research on overall and cause-specific mortality in patients with severe chronic pain is needed to inform clinical practice. The objective of this register-linkage study was to investigate whether patients with severe chronic pain referred to multidisciplinary pain treatment have higher cause-specific mortality rates than the general population. Methods In this register-linkage cohort study, data from 6,142 chronic pain patients (female: n=3,941, male: n=2,201, mean age: 48.2±14.2; range: 16–97 years) attending an interdisciplinary Pain Center in Odense, Denmark from 2005 to 2014 were linked to the Danish Register of Causes of Death. Age and gender standardized mortality ratios (SMRs) with their 95% confidence intervals (CI) were calculated and compared with those of the general population. Data from the general population was extracted from the Danish Register of Causes of Death, and Causes of death were classified according to national Classification of Disease (ICD-10). Results In all, 276 deaths (women: n=152, men: n=124) were observed among the chronic pain patients, and a six-fold higher overall mortality rate was found [SMR: 6.2 (95% CI: 5.5–7.0)] compared with the general population. Elevated cause-specific mortality rates were noted for chronic patients with respect to cancer and neoplasms [4.7 (95% CI: 3.7–5.9)], diseases of the circulatory system [5.7 (95% CI: 4.3–7.3)], diseases of the respiratory system [8.7 (95% CI: 6.2–11.9)], and suicide [7.3 (95% CI: 2.7–15.9)]. Conclusions The overall mortality rate of patients with severe chronic pain in this study was six-fold higher than the rate of the general population in this region. This was reflected in select specific causes of death (cancer and neoplasms, diseases of the circulatory system, diseases of the respiratory system, and suicide). The results are in agreement with previous studies and emphasize the need to understand which factors causally affect this increased mortality allowing for targeted interventions in similar chronic pain populations. Implications Potential reasons for the excess mortality should be adequately addressed by future studies in order to better target this in the management of these patients. The chronic pain population included in this study may have several comorbidities contributing to the increased mortality. To better address these aspects, complete medical profiles are needed in future studies. In addition, implementation of management strategies towards potential risk factors such as poor diet, low levels of physical activity, smoking, and high BMI as well as sleep deprivation and morphine use previously shown associated with having pain may reduce the excess mortality ratio.

Objective: The objective of this study was to describe the impact on patient-reported outcomes of introducing Shared Decision Making (SDM) and a Patient Decision Aid (PtDA) in the initial process of lung cancer diagnostics. Methods: We conducted a prospective cohort study, where a control cohort was consulted according to usual clinical practice. After introducing SDM through a PtDA and training of the staff, the SDM cohort was enrolled in the study. All patients completed four questionnaires: the Decisional Conflict Scale (DCS) before and after the consultation, the CollaboRATE scale after the consultation, and the Decision Regret Scale (DRS). Results: Patients exposed to SDM and a PtDA had significantly improved DCS scores after the consultation compared to the control group (a difference of 10.26, p = 0.0128) and significantly lower DRS scores (a difference of 8.98, p = 0.0197). Of the 82 control patients and 52 SDM patients 29% and 54%, respectively, gave the maximum score on the CollaboRATE scale (Pearson's chi(2) 8.0946, p = 0.004). Conclusion: The use of SDM and a PtDA had significant positive impact on patient-reported outcomes. Practice implications: Our results may encourage the increased uptake of SDM in the initial process of lung cancer diagnostics. (C) 2019 Elsevier B.V. All rights reserved.

Background Patients suffering from depression have a high risk of relapse and readmission in the weeks following discharge from inpatient wards. Electronic self-monitoring systems that offer patient-communication features are now available to offer daily support to patients, but the usability, acceptability, and adherence to these systems has only been sparsely investigated. Objective We aim to test the usability, acceptability, adherence, and clinical outcome of a newly developed computer-based electronic self-assessment system (the Daybuilder system) in patients suffering from depression, in the period from discharge until commencing outpatient treatment in the Intensive Outpatient Unit for Affective Disorders. Methods Patients suffering from unipolar major depression that were referred from inpatient wards to an intensive outpatient unit were included in this study before their discharge, and were followed for four weeks. User satisfaction was assessed using semiqualitative questionnaires and the System Usability Scale (SUS). Patients were interviewed at baseline and at endpoint with the Hamilton depression rating scale (HAM-D17), the Major Depression Inventory (MDI), and the 5-item World Health Organization Well-Being Index (WHO-5). In this four-week period patients used the Daybuilder system to self-monitor mood, sleep, activity, and medication adherence on a daily basis. The system displayed a graphical representation of the data that was simultaneously displayed to patients and clinicians. Patients were phoned weekly to discuss their data entries. The primary outcomes were usability, acceptability, and adherence to the system. The secondary outcomes were changes in: the electronically self-assessed mood, sleep, and activity scores; and scores from the HAM-D17, MDI, and WHO-5 scales. Results In total, 76% of enrolled patients (34/45) completed the four-week study. Five patients were readmitted due to relapse. The 34 patients that completed the study entered data for mood on 93.8% of the days (872/930), sleep on 89.8% of the days (835/930), activity on 85.6% of the days (796/930), and medication on 88.0 % of the days (818/930). SUS scores were 86.2 (standard deviation [SD] 9.7) and 79% of the patients (27/34) found that the system lived up to their expectations. A significant improvement in depression severity was found on the HAM-D17 from 18.0 (SD 6.5) to 13.3 (SD 7.3; P<.01), on the MDI from 27.1 (SD 13.1) to 22.1 (SD 12.7; P=.006), and in quality of life on the WHO-5 from 31.3 (SD 22.9) to 43.4 (SD 22.1; P<.001) scales, but not on self-assessed mood (P=.08). Mood and sleep parameters were highly variable from day-to-day. Sleep-offset was significantly delayed from baseline, averaging 48 minutes (standard error 12 minutes; P<.001). Furthermore, when estimating delay of sleep-onset (with sleep quality included in the model) during the study period, this showed a significant negative effect on mood (P=.03) Conclusions The Daybuilder systems performed well technically, and patients were satisfied with the system and had high adherence to self-assessments. The dropout rate and the gradual delay in sleep emphasize the need for continued clinical support for these patients, especially when considering sleep guidance.