Pro Evidence Research Articles

PNS191 US Payer Priorities in Evaluation of Clinical and Humanistic Outcomes Evidence

The objectives for this research are to: 1) understand how payers define unmet need and determine standards of care; 2) explore characteristics and acceptability of clinical and humanistic endpoints from RCTs and RWE; 3) understand methodological preferences for value evidence development in clinical trials and the real world. Senior-level decision-makers (n=10) from US payer organizations (n=9) representing 206.1 million member lives were recruited in May 2020 to participate in a web survey (10 topics) and qualitative telephone interview (approximately 25 minutes). Advisers were required to have a high level of knowledge surrounding formulary decision-making, clinical pathways and medical policy development, and manufacturer contracting. Descriptive statistics (e.g. Surveymonkey ranking scores, weighted means, % of mentions) and contextual analysis were used to analyze the results. Subanalyses were conducted by payer archetype. When defining unmet need, payers most frequently look for a high level of HCRU (weighted mean 4.67), poor survival prognosis (4.4), and drug related issues (i.e. AE management, loss of response) (3.9). In determining appropriate standard of care and eligible patient population, payers most frequently reference clinical guidelines (100%) and KOL feedback (90%). Cost is the most important factor in determining standard of care (2.5). Direct endpoints (4.7) are the most acceptable; PROs (3.2) and novel/emerging endpoints (3.3) are the least acceptable. Most payers (70%) expect an active comparator in an RCT. Head to head RCTs (4.9) are the most acceptable form of treatment comparison, followed by RWE comparative effectiveness research (4) and network meta-analysis (3.2). Quality of PRO evidence (2.4) is the most important characteristic in evaluating humanistic outcomes. Electronic health record studies (4.3) are the most acceptable form of RWE. Evaluation of clinical efficacy and safety evidence remain the gold standard for reimbursement decision making, while PROs continue to play a very minor role in the evaluation paradigm.

Plausible Argumentation in Eikotic Arguments: The Ancient Weak versus Strong Man Example

In this paper it is shown how plausible reasoning of the kind illustrated in the ancient Greek example of the weak and strong man can be analyzed and evaluated using a procedure in which the pro evidence is weighed against the con evidence using formal, computational argumentation tools. It is shown by means of this famous example how plausible reasoning is based on an audience’s recognition of situations of a type they are familiar with as normal and comprehensible in their shared common knowledge. The paper extends previous work on this example by using three new multiagent argumentation schemes closely related to the scheme for argument from negative consequences.

OP30 Impact Of Patient Reported Outcomes Data On Health Technology Assessments Of Acute Myeloid Leukemia

IntroductionPatient-reported outcomes (PRO) data are important in understanding patients’ experience of disease and treatment; however, PRO data are not universally collected or consistently included as part of a Health Technology Assessment (HTA) submission. Additionally, the HTA bodies’ response to PRO data vary, making the impact unclear. To understand the impact of PRO data on reimbursement decisions for Acute Myeloid Leukemia (AML) indications, an in-depth analysis of HTA bodies’ appraisals of AML and analogous indications was conducted.MethodsThis analysis was conducted using IQVIA's HTA Accelerator, which contains HTA appraisals from ≥100 HTA agencies in thirty-nine countries. Included in the analysis were single-technology assessments (original submissions, resubmissions, extensions of original indications, and renewals); relevant regulatory approvals and pivotal trials were also analyzed.ResultsOf the 185 AML appraisals from sixteen HTA bodies, 66 (36%) included PRO data. Within these, thirteen different PRO instruments were identified, none of which have been validated in patients with AML. For seven of twenty in-scope products, PRO evidence positively impacted ≥1 of the HTA decisions. Although the same HTA bodies (i.e., Scottish Medicines Consortium, pan-Canadian Oncology Drug Review, and the National Institute of Health and Care Excellence) generally accepted the PRO evidence, others were critical of the evidence (i.e., Haute Autorité de Santé and the Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen). The most common concerns raised by the HTA bodies regarding the PRO evidence included trial design and low patient response rate.ConclusionsOf the products that included PRO evidence in their HTA submissions, 35% received positive feedback from ≥1 HTA body on their submitted PRO evidence. Attention to PRO data collection is key to demonstrate the value of AML products to HTA bodies. Without these data, a clear gap in the understanding of patients’ experience is evident.

Plausible Argumentation in Eikotic Arguments: The Ancient Weak Versus Strong Man Example

In this paper it is shown how plausible reasoning of the kind illustrated in the ancient Greek example of the weak and strong man can be analyzed and evaluated using a procedure in which the pro evidence is weighed against the con evidence using formal, computational argumentation tools. It is shown by means of this famous example how plausible reasoning is based on an audience’s recognition of situations of a type they are familiar with as normal and comprehensible in their shared common knowledge. The paper extends previous work on this example by using three new multiagent argumentation schemes closely related to the scheme for argument from negative consequences.

Electromagnetic hypersensitivity (EHS) in the media – a qualitative content analysis of Norwegian newspapers

ObjectivesElectromagnetic hypersensitivity (EHS) is a condition characterized by experiencing symptoms after perceived exposure to weak electromagnetic fields (EMFs). There is substantial debate concerning the aetiology of EHS, but experimental data indicate no association between EHS and actual presence of EMFs. Newspapers play a key role in shaping peoples’ understanding of health-related issues. The aim of this study was to describe the content of newspaper articles concerning aetiology and treatment of EHS.DesignQualitative content analysis of newspaper articles.SettingNorwegian newspaper articles were identified using a comprehensive electronic media archive.ParticipantsNorwegian newspaper articles published between 1 February 2006 and 11 August 2010.Main outcome measuresStatements coded according to source of information, whether it was pro or con scientific evidence on EHS aetiology, and type of intervention presented as treatment option for EHS.ResultsOf the statements concerning EHS aetiology (n = 196), 35% (n = 69) were categorized as pro evidence, 65% (n = 127) as con evidence. Of the statements about EHS interventions assessed, 78% (n = 99) were categorized as ‘radiance reduction’, 4% (n = 5) as ‘complementary medicine’, and 18% (n = 23) as ‘other’. Cognitive behavioural therapy (CBT) and psychotropic drugs were never presented as possible treatment options for EHS.ConclusionsThe newspaper media discourse of EHS aetiology and recommended treatment interventions is much in conflict with the current evidence in the field. The majority of statements concerning aetiology convey that EHS is related to the presence of weak EMFs, and radiance reduction as the most frequently conveyed measure to reduce EHS-related symptoms.

Lunar-solar tidal deformation processes and seismoacoustic emission in the geo-environment volume

The deformation processes in the Earth’s crust are various, but the lunar–solar tidal deformation process, which is the most notable and controlled (relative deformations are 10 –6 to 10 –8 ), attracts great atten� tion. The influence of the tidal deformation processes on the periodicity of the variations in the physical characteristics of rock massifs has already been con� sidered [1–3]. The authors of [4] revealed the velocity fluctuations of elastic wave propagation through the massif of rocks with periods of 0.5, 1.0, 5.0, 9.5, and 14 days. This pro� vides evidence that the stressed state of the rock massif varies from the known periodicities of the tidal influ� ence with periods from semidiurnal to two weeks. The inhomogeneities in the Earth’s crust influence strongly the amplitudes of the tidal deformations. The amplitudes of the tidal waves in the fracture zones appear greater than on the platform or monolithic regions. The authors of [5] think that the available data on the diurnal and semidiurnal periods in the spectra

Local Computation of Decision-Relevant Net Sensory Evidence in Parietal Cortex

To investigate the contribution of parietal cortex to perceptual decisions, we trained monkeys on a perceptual decision task that allowed simultaneous experimental control over how much sensory evidence was provided for each of 3 possible alternative choices and recorded single unit activity and local field potentials (LFPs) from the lateral intraparietal area (LIP). While both the behavior and the spiking activity were largely determined by the difference between how much supporting sensory evidence was provided for a particular choice (pro evidence) and how much sensory evidence was provided for the other alternatives (anti evidence), the LFP reflected roughly the sum of these 2 components. Furthermore, the firing rates showed an earlier influence of the anti evidence than the pro evidence. These observations indicate that LIP does not simply receive already precomputed decision signals but that it plays an active role in computing the decision-relevant net sensory evidence and that this local computation is reflected in the LFP. The results further demonstrate that the competition between the different alternatives cannot solely be mediated by lateral or feedback inhibition, as proposed by a major class of decision models but that feedforward inhibition makes an important contribution.

The Search for Personality Genes

variations can occur in all possible combinations, there are more pos sible human DNA sequences than there are people who have ever walked the Earth, or who ever will be born before our solar system disappears. By studying twins and adoptees, behavioral geneticists have pro duced evidence that these differ ences in DNA have an important impact on how people think, act, and feel. Broad personality traits such as neuroticism or extraver sion, specific behaviors such as smoking cigarettes or drinking al cohol, and even subjective states such as happiness all show sub stantial heritability; typically, 40% to 60% of the variation between people is due to genes (Cloninger, Adolfsson, & Svrakic, 1996; Hamer, 1996). What behavioral genetics has not been able to determine is how many different genes are in volved in these traits and what

Do Rats and People Judge Negative Contingencies in the Same Way?

One of the most effective means of adaptation is to learn what will happen next. Learning about the causal structure of the environment allows organisms to predict future events and, if necessary, to modify their behavior in an anticipatory fashion. This learning requires a sen sitivity to the dependency of one event (the target) on another event (the signal). When the signal ap pears, the target may be more likely (positive), less likely (negative), or no more or less likely (neutral). It is usual to mathematize the stimulus dependent change in the probability of the target as a contingency (i.e., the probability of the target given the signal minus the probability of the target given no signal). An animal cannot provide a ver bal judgment, so how do we know that it has learned that one event is contingent upon another? In Pav lovian conditioning, what is called the conditioned stimulus (CS) is a signal for a target event important to the animal, such as food, which is called the unconditioned stimu lus (US). In the presence of the CS, the emergence of an anticipatory response, called the conditioned re sponse (CR), demonstrates the ani mal has learned the positive contin gency between the CS and the US. Ivan Pavlov was the first to pro vide evidence that animals can also

An aggregation of PRO and CON evidence for medical decision support systems

One promising way to increase the classification accuracy of medical decision support systems is to implement heuristic combinations of pattern recognition and artificial intelligence tools. A parallel between “cognition” model and differential diagnostic task is sketched accentuating the aggregation of activating and restraining inputs and corresponding PRO and CON evidence in medicine. On the basis of this paradigm a trainable model of a fuzzy neuron is proposed which resembles some elements from the physician's decision process. An example from aviation medicine is presented which demonstrates the enhanced performance.