"The challenge is the complexity" - A qualitative study about decision-making in advanced lung cancer treatment.

INTRODUCTION: The value of shared decision-making and decision aids (DA) has been well documented yet remain difficult to integrate into clinical practice. We wanted to investigate needs and challenges regarding decision-making about advanced lung cancer treatment after first-line therapy, focusing on DA applicability. METHODS: Qualitative data from separate, semi-structured focus groups with patients/relatives and healthcare professionals were analysed using systematic text condensation. 12 patients with incurable lung cancer, seven relatives, 12 nurses and 18 doctors were recruited from four different hospitals in Norway. RESULTS: The participants described the following needs and challenges affecting treatment decisions: 1) Continuity of clinician-patient-relationships as a basic framework for decision-making; 2) barriers to information exchange; 3) negotiation of autonomy; and 4) assessment of uncertainty and how to deal with it. Some clinicians feared DA would steal valuable time and disrupt consultations, arguing that such tools could not incorporate the complexity and uncertainty of decision-making. Patients and relatives reported a need for more information and the possibility both to decline or continue burdensome therapy. Participants welcomed interventions supporting information exchange, like communicative techniques and organizational changes ensuring continuity and more time for dialogue. Doctors called for tools decreasing uncertainty about treatment tolerance and futile therapy. CONCLUSION: Our study suggests it is difficult to develop an applicable DA for advanced lung cancer after first-line therapy that meets the composite requirements of stakeholders. Comprehensive decision support interventions are needed to address organizational structures, communication training including scientific and existential uncertainty, and assessment of frailty and treatment toxicity.

Pleural Empyema Caused by Streptococcus intermedius and Fusobacterium nucleatum: A Distinct Entity of Pleural Infections.

BACKGROUND: Many community-acquired pleural infections are caused by facultative and anaerobic bacteria from the human oral microbiota. The epidemiology, clinical characteristics, pathogenesis, and etiology of such infections are little studied. The aim of the present prospective multicenter cohort study was to provide a thorough microbiological and clinical characterization of such oral-type pleural infections and to improve our understanding of the underlying etiology and associated risk factors. METHODS: Over a 2-year period, we included 77 patients with community-acquired pleural infection, whereof 63 (82%) represented oral-type pleural infections. Clinical and anamnestic data were systematically collected, and patients were offered a dental assessment by an oral surgeon. Microbial characterizations were done using next-generation sequencing. Obtained bacterial profiles were compared with microbiology data from previous investigations on odontogenic infections, bacteremia after extraction of infected teeth, and community-acquired brain abscesses. RESULTS: From the oral-type pleural infections, we made 267 bacterial identifications representing 89 different species. Streptococcus intermedius and/or Fusobacterium nucleatum were identified as a dominant component in all infections. We found a high prevalence of dental infections among patients with oral-type pleural infection and demonstrate substantial similarities between the microbiology of such pleural infections and that of odontogenic infections, odontogenic bacteremia, and community-acquired brain abscesses. CONCLUSIONS: Oral-type pleural infection is the most common type of community-acquired pleural infection. Current evidence supports hematogenous seeding of bacteria from a dental focus as the most important underlying etiology. Streptococcus intermedius and Fusobacterium nucleatum most likely represent key pathogens necessary for establishing the infection.

A flexible formula for incorporating distributive concerns into cost-effectiveness analyses: Priority weights.

BACKGROUND: Cost effectiveness analyses (CEAs) are widely used to evaluate the opportunity cost of health care investments. However, few functions that take equity concerns into account are available for such CEA methods, and these concerns are therefore at risk of being disregarded. Among the functions that have been developed, most focus on the distribution of health gains, as opposed to the distribution of lifetime health. This is despite the fact that there are good reasons to give higher priority to individuals and groups with a low quality adjusted life expectancy from birth (QALE). Also, an even distribution of health gains may imply an uneven distribution of lifetime health. METHODS: We develop a systematic and explicit approach that allows for the inclusion of lifetime health concerns in CEAs, by creating a new priority weight function, PW = α+(t-γ)·C·e-ß·(t-γ), where t is the health measure. PW has several desirable properties. First, it is continuous and smooth, ensuring that people with similar health characteristics are treated alike. For example, those who achieve 50 QALE should be treated similarly to those who achieve 49.9 QALE. Second, it is flexible regarding shape and outcome measure (i.e., caters to other measures than QALE), so that a broad range of values may be modelled. Third, the coefficients have distinct roles. This allows for the easy manipulation of the PW's shape. In order to demonstrate how PW may be applied, we use data from a previous study and estimated the coefficients of PW based on two approaches. CONCLUSIONS: Equity concerns are important when conducting CEAs, which means that suitable PWs should be developed. We do not intend to determine which PW is the most appropriate, but to illustrate how a flexible general PW can be estimated based on empirical data.

Costs and expected gain in lifetime health from intensive care versus general ward care of 30,712 individual patients: a distribution-weighted cost-effectiveness analysis.

BACKGROUND: Clinicians, hospital managers, policy makers, and researchers are concerned about high costs, increased demand, and variation in priorities in the intensive care unit (ICU). The objectives of this modelling study are to describe the extra costs and expected health gains associated with admission to the ICU versus the general ward for 30,712 patients and the variation in cost-effectiveness estimates among subgroups and individuals, and to perform a distribution-weighted economic evaluation incorporating extra weighting to patients with high severity of disease. METHODS: We used a decision-analytic model that estimates the incremental cost per quality-adjusted life year (QALY) gained (ICER) from ICU admission compared with general ward care using Norwegian registry data from 2008 to 2010. We assigned increasing weights to health gains for those with higher severity of disease, defined as less expected lifetime health if not admitted. The study has inherent uncertainty of findings because a randomized clinical trial comparing patients admitted or rejected to the ICU has never been performed. Uncertainty is explored in probabilistic sensitivity analysis. RESULTS: The mean cost-effectiveness of ICU admission versus ward care was €11,600/QALY, with 1.6 QALYs gained and an incremental cost of €18,700 per patient. The probability (p) of cost-effectiveness was 95% at a threshold of €22,000/QALY. The mean ICER for medical admissions was €10,700/QALY (p = 97%), €12,300/QALY (p = 93%) for admissions after acute surgery, and €14,700/QALY (p = 84%) after planned surgery. For individualized ICERs, there was a 50% probability that ICU admission was cost-effective for 85% of the patients at a threshold of €64,000/QALY, leaving 15% of the admissions not cost-effective. In the distributional evaluation, 8% of all patients had distribution-weighted ICERs (higher weights to gains for more severe conditions) above €64,000/QALY. High-severity admissions gained the most, and were more cost-effective. CONCLUSIONS: On average, ICU admission versus general ward care was cost-effective at a threshold of €22,000/QALY (p = 95%). According to the individualized cost-effectiveness information, one in six ICU admissions was not cost-effective at a threshold of €64,000/QALY. Almost half of these admissions that were not cost-effective can be regarded as acceptable when weighted by severity of disease in terms of expected lifetime health. Overall, existing ICU services represent reasonable resource use, but considerable uncertainty becomes evident when disaggregating into individualized results.

Implementation of the 2013 amended Patients' Rights Act in Norway: Clinical priority guidelines and access to specialised health care.

In 2013, the Norwegian Patient Rights' Act was amended in order to simplify the priority setting process for specialized elective health care and to improve access to care. As a result of the amendment, priority for treatment is now determined by only two criteria: 1) clinical effectiveness; and 2) cost-effectiveness of the intervention. There are 33 clinical priority-setting guidelines organised by medical specialty, which help hospitals evaluate whether individual patients have a right to access care. Following the amendment of the Patient Rights' Act, these guidelines had to be revised in order to assure coherence with the new legislation. The revised guidelines define and score a total of 556 condition-intervention pairs, and will give all patients who are evaluated as having a need for specialist elective healthcare the right to access these services. This is different from the old guidelines, where patients could be evaluated as having a need but no right for treatment. According to the new guidelines, a much larger share of patients will be granted a right to necessary specialist healthcare service (93% of condition-intervention pairs versus 77% of condition-intervention pairs in the old guidelines). One reason for this is that the severity of the condition is no longer considered as part of the evaluation process, which means that patients with low levels of severity now have a right to receive treatment. In addition, a new "don't do" list of 40 conditions was created, which may prevent unnecessary treatment.

Priority rules as solutions to conflicting health care rights.

Recent health legislation in Norway significantly increases access to specialist care within a legally binding time frame. The paper describes the contents of the new legislation and introduces some of the challenges with proliferations of rights to health care. The paper describes some of the challenges associated with the proliferation of legal rights to health care. It explains the benefits of assessing the new law in the light of a rights framework. It then analyses the problematic aspects of establishing additional priority rules as solutions to rights conflicts. It then defends adequacy criteria for acceptable priority rules when such rules are unavoidable. It finally defends our proposed method and explores concrete applications.

Age, risk, and life expectancy in Norwegian intensive care: a registry-based population modelling study.

BACKGROUND: Knowledge about the expected life years gained from intensive care unit (ICU) admission could inform priority-setting decisions across groups of ICU patients and across medical specialties. The aim of this study was to estimate expected remaining lifetime for patients admitted to ICUs during 2008-2010 and to estimate the gain in life years from ICU admission. METHODS: This is a descriptive, population modelling study of 30,712 adult mixed ICU admissions from the Norwegian Intensive Care Registry. The expected remaining lifetime for each patient was estimated using a decision-analytical model. Transition probabilities were based on registered Simplified Acute Physiology Score (SAPS) II, and standard and adjusted Norwegian life-tables. RESULTS: The hospital mortality was 19.4% (n = 5,958 deaths). 24% of the patients were estimated to die within the first year after ICU admission in our model. Under an intermediate (base case), optimistic (O), and pessimistic (P) scenario with respect to long-term mortality, the average expected remaining lifetime was 19.4, 19.9, and 12.7 years. The majority of patients had a life expectancy of more than five years (84.8% in the base case, 89.4% in scenario O, and 55.6% in scenario P), and few had a life expectancy of less than one year (0.7%, 0.1%, and 12.7%). The incremental gain from ICU admission compared to counterfactual general ward care was estimated to be 0.04 (scenario P, age 85+) to 1.14 (scenario O, age < 45) extra life years per patient. CONCLUSIONS: Our research demonstrated a novel way of using routinely collected registry data to estimate and evaluate the expected lifetime outcomes for ICU patients upon admission. The majority had high life expectancies. The youngest age groups seemed to benefit the most from ICU admission. The study raises the question whether availability and rationing of ICU services are too strict in Norway.

Making use of equity sensitive QALYs: a case study on identifying the worse off across diseases.

BACKGROUND: Resource allocation decisions currently lack standard quantitative methods for incorporating concerns about the worse off when analysing the cost-effectiveness of medical interventions. OBJECTIVE: To explore and demonstrate how to identify who are the worse off without a new intervention by measuring lifetime Quality-Adjusted Life Years (QALYs) for patients across different conditions, and compare the results to using proportional shortfall of QALYs. METHODS: Case study of eight condition-intervention pairs that are relevant to priority setting in Norway; childhood deafness (unilateral cochlear implant), unruptured cerebral aneurysm (coiling), morbid obesity (RY gastric bypass), adult deafness (unilateral cochlear implant), atrial fibrillation (catheter ablation), hip osteoarthritis (hip replacement), rheumatoid arthritis (TNF inhibitor) and acute stroke (stroke unit). We extracted prospective QALYs without and with new interventions from published health technology assessments and economic evaluations. RESULTS: Among the eight cases, the lifetime QALY method and the proportional shortfall method yielded conflicting worse-off rank orders. Particularly two conditions had a substantial shift in ranking across the applications of the two methods: childhood deafness and acute stroke. Deaf children had the lowest expected lifetime QALYs (38.5 without a cochlear implant) and were worst off according to the lifetime approach, while patients with acute stroke had the second-highest lifetime QALYs (76.4 without stroke units). According to proportional shortfall of QALYs, patients with acute stroke were ranked as worse off than deaf children, which seems counterintuitive. CONCLUSION: This study shows that it is feasible to identify who are the worse off empirically by the application of lifetime QALYs and proportional shortfalls. These methods ease further examination of whether there is a true conflict between maximization and equity or whether these two concerns actually coincide in real world cases. It is yet to be solved whether proportional prospective health losses are more important than absolute shortfalls in expected lifetime health in judgements about who are worse off.