Governmental Immunity from Tort Liability: Pennsylvania\u27s Trend toward Abolition

The doctrine of governmental immunity from tort liability historically stems from the concept that the King can do no wrong, and that a vassal could not be heard to complain against his master

Criminal Law

Introducing Evidence Obtained by an Illegal Search and Seizure for Impeachment Purposes. Commonwealth v. Wright, 415 Pa. 55, 202 A.2d 79 (1964)

Constitutional Law - Civil Rights

Public Accommodations Under the Civil Rights Act of 1964. Heart of Atlanta Motel, Inc. v. United States, 85 Sup. Ct. 348 (1964)

Taxonomy based on science is necessary for global conservation

Peer reviewe

Why Are Outcomes Different for Registry Patients Enrolled Prospectively and Retrospectively? Insights from the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF).

Background: Retrospective and prospective observational studies are designed to reflect real-world evidence on clinical practice, but can yield conflicting results. The GARFIELD-AF Registry includes both methods of enrolment and allows analysis of differences in patient characteristics and outcomes that may result. Methods and Results: Patients with atrial fibrillation (AF) and ≥1 risk factor for stroke at diagnosis of AF were recruited either retrospectively (n = 5069) or prospectively (n = 5501) from 19 countries and then followed prospectively. The retrospectively enrolled cohort comprised patients with established AF (for a least 6, and up to 24 months before enrolment), who were identified retrospectively (and baseline and partial follow-up data were collected from the emedical records) and then followed prospectively between 0-18 months (such that the total time of follow-up was 24 months; data collection Dec-2009 and Oct-2010). In the prospectively enrolled cohort, patients with newly diagnosed AF (≤6 weeks after diagnosis) were recruited between Mar-2010 and Oct-2011 and were followed for 24 months after enrolment. Differences between the cohorts were observed in clinical characteristics, including type of AF, stroke prevention strategies, and event rates. More patients in the retrospectively identified cohort received vitamin K antagonists (62.1% vs. 53.2%) and fewer received non-vitamin K oral anticoagulants (1.8% vs . 4.2%). All-cause mortality rates per 100 person-years during the prospective follow-up (starting the first study visit up to 1 year) were significantly lower in the retrospective than prospectively identified cohort (3.04 [95% CI 2.51 to 3.67] vs . 4.05 [95% CI 3.53 to 4.63]; p = 0.016). Conclusions: Interpretations of data from registries that aim to evaluate the characteristics and outcomes of patients with AF must take account of differences in registry design and the impact of recall bias and survivorship bias that is incurred with retrospective enrolment. Clinical Trial Registration: - URL: http://www.clinicaltrials.gov . Unique identifier for GARFIELD-AF (NCT01090362)

Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry.

BACKGROUND: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION: Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

Identifying a Core Domain Set to Assess Psoriasis in Clinical Trials

Importance: There is no consensus on which domains should be measured or which instruments should be used in clinical trials for psoriasis therapies. Objective: To achieve international consensus among psoriasis stakeholders on a core set of domains that should be measured in all psoriasis clinical trials. Design, Setting, and Participants: Literature review, pre-Delphi survey exercises, nominal group discussions, and audience voting at 4 stakeholder meetings were used to develop candidate domains for 2 rounds of a Delphi survey. Stakeholders were patients or advocates of patients with psoriasis and health care professionals (HCPs) with expertise in psoriasis, including physicians, scientists, advocacy organization representatives, and regulators. Delphi surveys were conducted electronically from October through December 2015 and between September and October 2016. Stakeholder discussions with audience response voting were conducted at live meetings in the United States, Canada, and Italy from January 2013 to December 2016 to refine and ratify the core set of domains. Main Outcomes and Measures: Two rounds of an electronic Delphi survey were used to determine consensus. A domain was considered core (ie, should be measured in all trials) if a threshold consensus of at least 70% was met in both patient and HCP groups. Domains meeting consensus in only 1 group were considered to be important but were not required to be measured in all trials ( middle ring ). These domains were included for rerating in round 2. Domains that did not meet consensus in either of the groups ( outer ring ) were considered to be of uncertain importance and were placed in the research agenda. Results: In round 1 of the Delphi survey, 107 HCPs and 14 patients participated. Most HCPs (72 [67%]) were dermatologists between 46 and 64 years old (71 [66%]), white (78 [73%]), and male (75 [70%]) from North America (60 [57%]) and Europe (34 [32%]).There were 10 pharmaceutical industry clinical or health economic scientists, 3 advocacy organization representatives, 2 regulatory agency representatives, and 5 other. In the second round, 77 HCPs and 15 patients participated. Of the 20 candidate domains, the following 6 met consensus as core domains: skin manifestations, psoriasis and psoriatic arthritis symptoms, health-related quality of life, investigator global assessment, patient global assessment, and treatment satisfaction. Secondary skin manifestations as well as nail, inverse, genital, and guttate psoriasis were classified as important but not mandatory. Psoriatic arthritis signs, work productivity or participation, economic impact (direct and indirect cost), and cardiovascular disease comprised the research agenda. Conclusions and Relevance: This iterative Delphi process yielded international consensus among professional and patient stakeholders on 6 domains that should be measured in all clinical trials for psoriasis. Future International Dermatology Outcome Measures group efforts will focus on development of a core outcome measurement set for psoriasis trials

Are Your Patients Satisfied? A Systematic Review of Treatment Satisfaction Measures in Psoriasis

Treatment satisfaction is paramount to the field of dermatology. Treatment dissatisfaction directly impacts patient outcomes and health care delivery. A critical need exists for standardized, validated treatment satisfaction measures in dermatology. Comprehensive evaluation of the performance of treatment satisfaction instruments used in psoriasis is lacking. We sought to critically appraise the literature on measurement properties of treatment satisfaction instruments used in psoriasis. We performed a systematic review to identify treatment satisfaction instruments used in psoriasis and corresponding studies on their measurement properties. We followed the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology to inform a best evidence synthesis. Eleven instruments were identified. Six achieved positive content validity ratings, 2 achieved positive reliability and structural validity ratings, and 1 achieved a positive internal consistency rating. The REFlective evaLuation of psoriasis Efficacy of Treatment and Severity (REFLETS) and the Spanish Satisfaction With Treatment of Psoriasis Questionnaire (SSWTPQ) had the highest overall performance. Measurement property data for treatment satisfaction instruments were found to be insufficient in identifying a single best treatment satisfaction instrument for psoriasis. Additional studies are required to better characterize the measurement properties of treatment satisfaction measures and allow for standardized assessments across psoriasis clinical trials and clinical practice

Achieving International Consensus on the Assessment of Psoriatic Arthritis in Psoriasis Clinical Trials: An International Dermatology Outcome Measures (IDEOM) Initiative

Psoriatic arthritis (PsA) is rarely assessed in psoriasis randomized controlled trials (RCT); thus, the effect of psoriasis therapy on PsA is unknown. The International Dermatology Outcome Measures (IDEOM) has included PsA Symptoms as part of the core domains to be measured in psoriasis RCT. This study aimed to achieve consensus about screening for PsA and how to measure for PsA Symptoms in psoriasis RCT. At the IDEOM 2017 Annual Meeting, stakeholders voted on the role of PsA screening in psoriasis RCT. To select measures for PsA Symptoms , we adapted the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines. Three potential measures were selected. At the meeting, stakeholders voted on the validity, feasibility, and responsiveness of these measures. Of the 47 stakeholders, 93% voted that all psoriasis trial participants should be screened for PsA. PsA Symptoms measures included Patient Global (PG)-arthritis, Routine Assessment Patient Index Data (RAPID)-3, and Psoriatic Arthritis Impact of Disease (PsAID)-9. During the voting, more than 50% of the voters agreed that RAPID3 and PsAID9 were good measures for PsA Symptoms, able to capture all its essential elements. PsAID9 was considered the most feasible instrument, followed by RAPID3 and PG-arthritis, respectively. Finally, most participants agreed that RAPID3 and PsAID9 were responsive measures. Most study participants voted that all subjects in a psoriasis clinical trial should be screened for PsA. RAPID3 and PsAID9 outperformed PG-arthritis in measuring PsA Symptoms. This will be followed by a Delphi survey involving a larger stakeholder group