Improving quality of life in cancer patients through higher participation and health literacy: study protocol for evaluating the oncological social care project (OSCAR)

BACKGROUND: Cancer patients experience psychological and social distress due to their medical treatment and social issues. However, continuous and specialized social support is still lacking. In Germany, a group of company health insurance funds has developed an approach to support cancer patients with monthly structured interviews conducted by specially trained Social Care Nurses. The nurses will identify patient needs in order to provide help with medical, personal, and social matters. One aim of the scientific evaluation is to analyze the effect of the consultations on various patient-reported outcomes, especially quality of life. The evaluation concept will be described in this study protocol. METHODS/DESIGN: The evaluation is a non-randomized, controlled, multi-center intervention study with a mixed-method design. It consists of three research modules which include primary data from questionnaires, and claims data from the health insurance funds. In Module 1, cancer patients will be recruited to form an intervention group (OSCAR, n = 150) and a control group (n = 200) in four study centers for a period of 1 year. One baseline and three follow-up questionnaires will be conducted to survey the patient-reported outcomes. Relevant secondary outcomes are health literacy, participation, and physician-patient communication. In Module 2, claims data will be used to analyze cost effects and thereby assess effectivity and hospitalization. Module 3 will involve a qualitative analysis of project diaries kept by the Social Care Nurses. The diaries will record the nurses' practical experiences and the benefits of deploying OSCAR across the German healthcare system. DISCUSSION: OSCAR is an innovative way of providing cancer patients with continuous support to improve their quality of life. The evaluation concept aims to assess the effects of the monthly consultations by the Social Care Nurses on the patients, and will use a mixed-method design. The results are important for assessing the transferability of OSCAR to the healthcare system as a whole. TRIAL REGISTRATION: German Clinical Trials Register (DRKS-ID: DRKS00013640 ). Registered 29 December 2017

'Making People Happy, Not Making Happy People': A Defense of the Asymmetry Intuition in Population Ethics

This dissertation provides a defense of the normative intuition known as the Procreation Asymmetry, according to which there is a strong moral reason not to create a life that will foreseeably not be worth living, but there is no moral reason to create a life just because it would foreseeably be worth living. Chapter 1 investigates how to reconcile the Procreation Asymmetry with our intuitions about another recalcitrant problem case in population ethics: Derek Parfit's Non-Identity Problem. I show that what has prevented philosophers from developing a theory that gives a satisfactory account of both these problems is their tacit commitment to a teleological conception of well-being, as something to be `promoted'. Replacing this picture with one according to which our reasons to confer well-being on people are conditional on their existence allows me to do better. It also enables us to understand some of the deep structural parallels between seemingly disparate normative phenomena such as procreating and promising. Chapter 2 attempts to connect my defense of the Procreation Asymmetry to corresponding evaluative claims about the goodness of the outcomes produced by procreative decisions. I propose a view, the `biconditional buck-passing view of outcome betterness', according to which facts about the comparative goodness of outcomes are a function of our reasons for bringing about one outcome rather than another under certain conditions. This enables me to derive an Evaluative Procreation Asymmetry from the corresponding normative claims established in Chapter 1. The biconditional buck-passing view also provides me with a principled basis for challenging a version of the Independence of Irrelevant Alternatives Principle. This, in turn, permits me to provide a novel solution to another famous problem in population ethics: Parfit's Mere Addition Paradox. Finally, in Chapter 3, I rebut some key objections to the Procreation Asymmetry by showing that upholding it does not commit us to anti-natalism and that it is compatible with a moral concern for the long-term survival of humanity.Philosoph

Characteristics and patient-reported outcomes associated with dropout in severely affected oncological patients: an exploratory study

Background: Patient-reported outcome measures (PROMs) are commonly-used surrogates for clinical outcomes in cancer research. When researching severe diseases such as cancer, it is difficult to avoid the problem of incomplete questionnaires from drop-outs or missing data from patients who pass away during the observation period. The aim of this exploratory study was to explore patient characteristics and the patient-reported outcomes associated with the time-to-dropout. Methods: In an Oncological Social Care Project (OSCAR) study, the condition of the participants was assessed four times within 12 months (t0: baseline, t1: 3 months, t2: 6 months, and t3: 12 months) by validated PROMs. We performed competing-risk regressions based on Fine and Gray's proportional sub-distribution hazards model for exploring factors associated with time-to-dropout. Death was considered a competing risk. Results: Three hundred sixty-two participants were analyzed in the study. 193 (53.3%) completed a follow-up after 12 months, 67 (18.5%) patients dropped out, and 102 patients (28.2%) died during the study period. Poor subjective social support was related to a higher risk of drop-out (SHR = 2.10; 95%CI: 1.01-4.35). Lower values in health-related quality of life were related to drop-out and death. The sub-scales global health status/QoL, role functioning, physical functioning, and fatigue symptom in the EORTC QLQ-C30 were key characteristics of early drop-out. Conclusion: Severely affected cancer patients with poor social support and poor quality of life seem more likely to drop out of studies than patients with higher levels of social support and a better quality of life. This should be considered when planning studies to assess advanced cancer patients. Methods of close continued monitoring should be actively used when patient experiences a substantial deterioration in their health-related quality of life and symptoms during the study. Results for such studies have to be interpreted with caution in light of specific drop-out mechanisms

a qualitative study comparing urban and rural sites

Objectives: The increasing number of low-acuity visits to emergency departments (ED) is an important issue in Germany, despite the fact that all costs of inpatient and outpatient treatment are covered by mandatory health insurance. We aimed to explore the motives of patients categorised with low- acuity conditions for visiting an ED. Methods: We conducted a qualitative study in two urban and one rural ED. We recruited a purposive sample of adults, who were assigned to the lowest two categories in the Manchester triage system. One-to-one interviews took place in the ED during patients' waiting time for treatment. Interview transcripts were analysed using the qualitative data management software MAXQDA. A qualitative content analysis approach was taken to identify motives and to compare the rural with the urban sites. Results: A total of 86 patients were asked to participate; of these, n=15 declined participation and n=7 were excluded because they were admitted as inpatients, leaving a final sample of 40 female and 24 male patients. We identified three pathways leading to an ED visit: (1) without primary care contact, (2) after unsuccessful attempts to see a resident specialist or general practitioner (GP) and (3) recommendation to visit the ED by an outpatient provider. The two essential motives were (1) convenience and (2) health anxiety, triggered by time constraints and focused usage of multidisciplinary medical care in a highly equipped setting. All participants from the rural region were connected to a GP, whom they saw more or less regularly, while more interviewees from the urban site did not have a permanent GP. Still, motives to visit the ED were in general the same. Conclusions: We conclude that the ED plays a pivotal role in ambulatory acute care which needs to be recognised for adequate resource allocation. Trial registration number: DRK S0000605

Identifying and handling unbalanced baseline characteristics in a non-randomized, controlled, multicenter social care nurse intervention study for patients in advanced stages of cancer

Purpose: Given the psychosocial burdens patients in advanced stages of cancer face, innovative care concepts are needed. At the same time, such vulnerable patient groups are difficult to reach for participation in intervention studies and randomized patient inclusion may not be feasible. This article aims to identify systematic biases respectively selection effects occurring during the recruitment phase and to discuss their potential causes based on a non-randomized, multicenter intervention study with patients in advanced stages of cancer. Methods: Patients diagnosed with at least one of 16 predefined cancers were recruited at four hospitals in three German cities. The effect of social care nurses' continuous involvement in acute oncology wards was measured by health-related quality of life (EORTC QLQ-C30), information and participation preferences, decisional conflicts, doctor-patient communication, health literacy and symptom perception. Absolute standardized mean difference was calculated as a standardized effect size to test baseline characteristics balance between the intervention and control groups. Results: The study enrolled 362 patients, 150 in the intervention and 212 in the control group. Except for gender, both groups differed in relevant socio-demographic characteristics, e.g. regarding age and educational background. With respect to the distribution of diagnoses, the intervention group showed a higher symptom burden than the control group. Moreover, the control group reported better quality of life at baseline compared to the intervention group (52.6 points (SD 21.7); 47.8 points (SD 22.0), ASMD = 0.218, p = 0.044). Conclusion: Overall, the intervention group showed more social and health vulnerability than the control group. Among other factors, the wide range of diagnoses included and structural variation between the recruiting clinics increased the risk for bias. We recommend a close, continuous monitoring of relevant social and health-related characteristics during the recruitment phase as well as the use of appropriate statistical analysis strategies for adjustment, such as propensity score methods

Suitability of current definitions of ambulatory care sensitive conditions for research in emergency department patients: a secondary health data analysis

Objective: The aim of this study was to investigate the suitability of existing definitions of ambulatory care sensitive conditions (ACSC) in the setting of an emergency department (ED) by assessing ACSC prevalence in patients admitted to hospital after their ED stay. The secondary aim was to identify ACSC suitable for specific application in the ED setting. Design: Observational clinical study with secondary health data. Setting: Two EDs of the Charite-Universitatsmedizin Berlin. Participants: All medical ED patients of the 'The Charite Emergency Medicine Study' (CHARITEM) study, who were admitted as inpatients during the 1-year study period (n=13 536). Outcome measures: Prevalence of ACSC. Results: Prevalence of ACSC in the study population differed significantly depending on the respective ACSC set used. Prevalence ranged between 19.1% (95% CI 18.4% to 19.8%; n=2586) using the definition by Albrecht et al and 36.6% (95% CI 35.8% to 37.5%; n=4960) using the definition of Naumann et al. (p<0.001). Overall ACSC prevalence (ie, when using all diagnoses used in any of the assessed ACSC-definitions) was 48.1% (95% CI 47.2% to 48.9%; n=6505). Some frequently observed diagnoses such as 'convulsion and epilepsy' (prevalence: 3.4%, 95% CI 3.1% to 3.7%; n=455), 'diseases of the urinary system' (prevalence: 1.4%; 95% CI 1.2% to 1.6%; n=191) or 'atrial fibrillation and flutter' (prevalence: 1.0%, 95% CI 0.8% to 1.2%, n=134) are not included in all of the current ACSC definitions. Conclusions: The results highlight the need for an optimised, ED-specific ACSC definition. Particular ACSC diagnoses (such as 'convulsion and epilepsy' or 'diseases of the urinary system' and others) seem to be of special relevance in an ED population but are not included in all available ACSC definitions. Further research towards the development of a suitable and specific ACSC definition for research in the ED setting seems warranted

Suitability of the German version of the Manchester Triage System to redirect emergency department patients to general practitioner care: a prospective cohort study

Objectives: To investigate the suitability of the German version of the Manchester Triage System (MTS) as a potential tool to redirect emergency department (ED) patients to general practitioner care. Such tools are currently being discussed in the context of reorganisation of emergency care in Germany. Design: Prospective cohort study. Setting: Single centre University Hospital Emergency Department. Participants: Adult, non-surgical ED patients. Exposure: A non-urgent triage category was defined as a green or blue triage category according to the German version of the MTS. Primary and secondary outcome measures: Surrogate parameters for short-term risk (admission rate, diagnoses, length of hospital stay, admission to the intensive care unit, in-hospital and 30-day mortality) and long-term risk (1-year mortality). Results: A total of 1122 people presenting to the ED participated in the study. Of these, 31.9% (n= 358) received a non-urgent triage category and 68.1% (n= 764) were urgent. Compared with non-urgent ED presentations, those with an urgent triage category were older (median age 60 vs 56 years, p= 0.001), were more likely to require hospital admission (47.8% vs 29.6%) and had higher inhospital mortality (1.6% vs 0.8%). There was no significant difference observed between non-urgent and urgent triage categories for 30-day mortality (1.2% [n= 4] vs 2.2% [n= 15]; p= 0.285) or for 1-year mortality (7.9% [n= 26] vs 10.5% [n= 72]; p= 0.190). Urgency was not a significant predictor of 1-year mortality in univariate (HR= 1.35; 95% CI 0.87 to 2.12; p= 0.185) and multivariate regression analyses (HR= 1.20; 95% CI 0.77 to 1.89; p= 0.420). Conclusions: The results of this study suggest the German MTS is unsuitable to safely identify patients for redirection to non-ED based GP care

Treatment versus prevention in the fight against HIV/AIDS and the problem of identified versus statistical lives

For years, discussions about the best way to combat the HIV/AIDS pandemic have pitted proponents of scaling up antiretroviral treatment for people already suffering from AIDS against other writers, who advocate for a focus on more cost-effective prevention measures. In an important recent article, Dan Brock and Daniel Wikler (2009) frame the underlying moral issue as a debate about whether, given long-term budget constraints, there are any moral grounds to privilege the saving of identified lives through antiretroviral treatment, even if concentrating on preventive methods could save more (statistical) lives overall. In this chapter, I critically examine Brock and Wikler’s contention that since all human lives have equal worth, there can be no sound moral basis for giving any priority to the saving of identified over statistical lives, all else equal. In so doing, I develop a novel account of how the choice between “treatment” and “prevention” in population-level health policy intersects the problem of identified versus statistical lives. The chapter concludes with a postscript on “treatment-as-prevention,” a new avenue of AIDS research that stresses the preventive benefits of early antiretroviral treatment. I argue that, while scientifically promising, treatment-as-prevention does not transcend the ethical dichotomy between treatment and prevention explored in this chapter