Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs.

A number of important drugs used to treat cancer-many of which serve as the backbone of modern chemotherapy regimens-have outdated prescribing information in their drug labeling. The Food and Drug Administration is undertaking a pilot project to develop a process and criteria for updating prescribing information for longstanding oncology drugs, based on the breadth of knowledge the cancer community has accumulated with the use of these drugs over time. This article highlights a number of considerations for labeling updates, including selecting priorities for updating; data sources and evidentiary criteria; as well as the risks, challenges, and opportunities for iterative review to ensure prescribing information for oncology drugs remains relevant to current clinical practice

The use of dose quantities in radiological protection: ICRP publication 147 Ann ICRP 50(1) 2021.

The International Commission on Radiological Protection has recently published a report (ICRP Publication 147;Ann. ICRP50, 2021) on the use of dose quantities in radiological protection, under the same authorship as this Memorandum. Here, we present a brief summary of the main elements of the report. ICRP Publication 147 consolidates and clarifies the explanations provided in the 2007 ICRP Recommendations (Publication 103) but reaches conclusions that go beyond those presented in Publication 103. Further guidance is provided on the scientific basis for the control of radiation risks using dose quantities in occupational, public and medical applications. It is emphasised that best estimates of risk to individuals will use organ/tissue absorbed doses, appropriate relative biological effectiveness factors and dose-risk models for specific health effects. However, bearing in mind uncertainties including those associated with risk projection to low doses or low dose rates, it is concluded that in the context of radiological protection, effective dose may be considered as an approximate indicator of possible risk of stochastic health effects following low-level exposure to ionising radiation. In this respect, it should also be recognised that lifetime cancer risks vary with age at exposure, sex and population group. The ICRP report also concludes that equivalent dose is not needed as a protection quantity. Dose limits for the avoidance of tissue reactions for the skin, hands and feet, and lens of the eye will be more appropriately set in terms of absorbed dose rather than equivalent dose

From Vampire to Apollo: William Blake's Ghosts of the Flea (c. 1819-20)

Varley’s Zodiacal Physiognomy and Blake’s Visionary Heads are the two mainstays of a project which involved séance-like meetings at Varley’s house. While the lights were still on, Varley’s guests would have listened to the stories about the flea. With The Ghost of a Flea in front of them, the recitals of the flea’s pompous speeches, combined with the fact that it was just a ghost who leered after human blood, Varley’s guests may have laughed very heartily, if not in front of him then behind his back. Each evening followed the same protocol. When the lights were off, Varley would call out a name and Blake would look around, suddenly exclaiming ‘There he is!’ and start drawing. The flea is the most striking of the Visionary Heads, though it is not the only head which exists in different versions. If appearance is elemental to any kind of judgement of one human being of another, then Blake deliberately confused Varley. By working up the sketch, he played on Varley’s expectations; he presented him with an extraordinary and very puzzling painting, The Ghost of a Flea. But why, if Blake could have chosen any monster, did he settle on the ghost of a flea

Patient-Centered Outcomes Measurement: Does It Require Information From Patients?

Purpose: Since collecting outcome measure data from patients can be expensive, time-consuming, and subject to memory and nonresponse bias, we sought to learn whether outcomes important to patients can be obtained from data in the electronic health record (EHR) or health insurance claims. Methods: We previously identified 21 outcomes rated important by patients who had advanced imaging tests for back or abdominal pain. Telephone surveys about experiencing those outcomes 1 year after their test from 321 people consenting to use of their medical record and claims data were compared with audits of the participants’ EHR progress notes over the time period between the imaging test and survey completion. We also compared survey data with algorithmically extracted data from claims files for outcomes for which data might be available from that source. Results: Of the 16 outcomes for which patients’ survey responses were considered to be the best information source, only 2 outcomes for back pain and 3 for abdominal pain had kappa scores above a very modest level of ≥ 0.2 for chart audit of EHR data and none for algorithmically obtained EHR/claims data. Of the other 5 outcomes for which claims data were considered to be the best information source, only 2 outcomes from patient surveys and 3 outcomes from chart audits had kappa scores ≥ 0.2. Conclusions: For the types of outcomes studied here, medical record or claims data do not provide an adequate source of information except for a few outcomes where patient reports may be less accurate

The science of clinical practice: disease diagnosis or patient prognosis? Evidence about "what is likely to happen" should shape clinical practice.

BACKGROUND: Diagnosis is the traditional basis for decision-making in clinical practice. Evidence is often lacking about future benefits and harms of these decisions for patients diagnosed with and without disease. We propose that a model of clinical practice focused on patient prognosis and predicting the likelihood of future outcomes may be more useful. DISCUSSION: Disease diagnosis can provide crucial information for clinical decisions that influence outcome in serious acute illness. However, the central role of diagnosis in clinical practice is challenged by evidence that it does not always benefit patients and that factors other than disease are important in determining patient outcome. The concept of disease as a dichotomous 'yes' or 'no' is challenged by the frequent use of diagnostic indicators with continuous distributions, such as blood sugar, which are better understood as contributing information about the probability of a patient's future outcome. Moreover, many illnesses, such as chronic fatigue, cannot usefully be labelled from a disease-diagnosis perspective. In such cases, a prognostic model provides an alternative framework for clinical practice that extends beyond disease and diagnosis and incorporates a wide range of information to predict future patient outcomes and to guide decisions to improve them. Such information embraces non-disease factors and genetic and other biomarkers which influence outcome. SUMMARY: Patient prognosis can provide the framework for modern clinical practice to integrate information from the expanding biological, social, and clinical database for more effective and efficient care

Contemporary changes and civil society in Portugal and the Russian Federation

Portugal and the Russian Federation share some aspects of traditional culture and similar experiences in modern history, but they also exhibit significant differences that determine specific modes of civil society’s development. Results of a comparative and diachronic analysis show that the major differences between the two countries reside in civil society’s openness and composition. Organized civil society is not very distinct in relative size when comparing Portugal and the Russian Federation, but it is globally more autonomous, expressive, trusted and institutionalized in Portugal than in the Russian Federation and among the factors that contribute to this condition are an earlier and revolutionary transition to democracy, a larger middle class, a greater prevalence of the value of interdependence, and a regime that endorses bigger public social expenditure in Portugal, all this within the framework of the European Union that has a longer history of social demand and institutional incentives for civil society. Despite those unequal conditions, civil society faces similar current challenges in both countries, mainly with the outsourcing of the public provision of social services.info:eu-repo/semantics/acceptedVersio

A time and motion study of patients presenting at the accident and emergency department at Mater Dei Hospital

<p>Abstract</p> <p>Background</p> <p>To carry out a time and motion study of patients presenting at the Emergency Department (ED) by measuring waiting times at the ED dept throughout the day. The objectives were:</p> <p indent="1">• to determine whether waiting times are prolonged, and</p> <p indent="1">• if prolonged, at which station(s) bottlenecks occur most often in terms of duration and frequency.</p> <p>Results will be compared to the United Kingdom guidelines of stay at the emergency department.</p> <p>Methods</p> <p>A group of 11 medical students monitored all patients who attended ED between 0600 hours on the 25^thAugust and 0600 hours on the 1st September 2008. For each 24 hour period, students were assigned to the triage room and the 3 priority areas where they monitored all patient-related activity, movement and waiting times so that length of stay (LOS) could be recorded. The key data recorded included patient characteristics, waiting times at various ED process stages, tests performed, specialist consultations and follow up until admitted, discharged, or referred to another hospital area. Average waiting times were calculated for each priority area. Bottle-necks and major limiting factors were identified. Results were compared against the United Kingdom benchmarks - i.e. 1 hour until first assessment, and 4 hours before admitting/discharge.</p> <p>Results</p> <p>1779 patients presented to the ED in the week monitored. As expected, patients in the lesser priority areas (i.e. 2 & 3) waited longer before being assessed by staff. Patients requiring laboratory and imaging investigations had a prolonged length of stay, which varied depending on specific tests ordered. Specialty consultation was associated with longer waiting times. A major bottleneck identified was waiting times for inpatient admission.</p> <p>Conclusions</p> <p>In conclusion, it was found that 30.3% of priority 1 patients, 86.3% of priority 2 patients and 76.8% of priority 3 patients waited more than 1 hour for first assessment. We conclude by proposing several changes that may expedite throughput.</p