Contemporary Practice Patterns for Palliative Radiation Therapy of Bone Metastases: Impact of a Quality Improvement Project on Extended Fractionation.

PURPOSE: Radiation therapy effectively palliates bone metastases, although variability exists in practice patterns. National recommendations advocate against using extended fractionation (EF) with courses greater than 10 fractions. We previously reported EF use of 14.8%. We analyzed practice patterns within a statewide quality consortium to assess EF use in a larger patient population after implementation of a quality measure focused on reducing EF. METHODS AND MATERIALS: Patients treated for bone metastases within a statewide radiation oncology quality consortium were prospectively enrolled from March 2018 through October 2020. The EF quality metric was implemented March 1, 2018. Data on patient, physician, and facility characteristics; fractionation schedules; and treatment planning and delivery techniques were collected. Multivariable binary logistic regression was used to assess EF. RESULTS: Twenty-eight facilities enrolled 1445 consecutive patients treated with 1934 plans. The median number of treatment plans per facility was 52 (range, 7-307). Sixty different fractionation schedules were used. EF was delivered in 3.4% of plans. Initially, EF use was lower than expected and remained low over time. Significant predictors for EF use included complicated metastasis (odds ratio [OR], 2.04; 95% confidence interval [CI], 1.04-4.02; P = .04), lack of associated central nervous system or visceral disease (OR, 2.27; 95% CI, 1.2-4.2; P = .01), nonteaching versus teaching facilities (OR, 8.97; 95% CI, 2.1-38.5; P < .01), and treating physicians with more years in practice (OR, 12.82; 95% CI, 3.9-42.4; P < .01). CONCLUSIONS: Within a large, prospective population-based data set, fractionation schedules for palliative radiation therapy of bone metastases remain highly variable. Resource-intensive treatments including EF persist, although EF use was low after implementation of a quality measure. Complicated metastases, lack of central nervous system or visceral disease, and treatment at nonteaching facilities or by physicians with more years in practice significantly predict use of EF. These results support ongoing efforts to more clearly understand and address barriers to high-value radiation approaches in the palliative setting.

Accounting for Dignity in the Iliad, Ajax, Electra, and the Clinical Encounter: Debating the "End" of Life.

This essay explores as "dignity-denuding" case studies Greek tragic protagonists in order to discuss the ethical problematics involved in "accounting for" such figures: i.e. both diagnosing them and constructing (broken) narratives into which they are fitted. Starting with epic's positive constructions of "aidos" (shame), it contrasts Ajax and Phaedra-each deprived of their dignity by what one psychiatrist called a "violent storm"-as seeking to construct a restorative story of self after trauma. Finally, it argues that Sophocles's Electra's presentation of her "shameful" state has been misread, by both psychiatrists and dramaturgs seeking, perhaps needing?, to impose an inappropriate closure on both her and the play. It is suggestive and significant that this so-called "hysteric" should attract accounts which so impose a diagnosis, impose an "end." The essay concludes that such imposition on anyone who has had their dignity taken away, whether protagonist or patient, is the final indignity.

Commentary on AAPS Workshop: dissolution testing for the twenty-first century: linking critical quality attributes and critical process parameters to clinically relevant dissolution.

This is a summary report of the workshop entitled "Dissolution Testing for the Twenty-first Century: Linking Critical Quality Attributes and Critical Process Parameters to Clinically Relevant Dissolution," organized by the In Vitro Release and Dissolution Testing Focus Group of the American Association of Pharmaceutical Scientists. Participants from the pharmaceutical industry, regulatory authorities, and academia in the US, Europe, and Japan attended this workshop to review, discuss, and explore the role of traditional dissolution testing in the new arena of Quality by Design (QbD) and Process Analytical Technology (PAT). Other areas of discussion were the use of the dissolution test to evaluate drug release from novel dosage forms, challenges in dissolution testing and specification setting, and dissolution apparatus calibration using performance verification tablets versus mechanical calibration. The workshop identified areas where further research and collaboration are needed to advance knowledge and understanding of the science of dissolution. Views expressed in this report are those of the authors and do not necessarily reflect those of the FDA and USP.

Tobacco and alcohol consumption and the risk of non-Hodgkin lymphoma.

OBJECTIVE: The aim was to test whether non-Hodgkin lymphoma (NHL) is associated with smoking or alcohol. METHODS: A case-control study recruited NHL cases aged 18-64 in parts of England between 1998 and 2001. One control was matched to each case on sex, date of birth and area of residence. Self-reported histories of tobacco and alcohol consumption were collected during face-to-face interviews. RESULTS: Among 700 cases and 915 controls, no association of smoking with the risk of NHL was observed [odds ratio (OR) = 1.04, 95% confidence interval (CI): 0.85-1.28]. Risks were not raised with age started smoking, number of years smoked, and number of years stopped smoking. Compared with persons who drank alcohol once or twice a week, neither abstainers (OR = 1.03, 95% CI: 0.64-1.67), nor consumers of alcohol one to five times a year (OR = 1.35, 95% CI: 0.95-1.93), one to two times a month (OR = 1.20, 95% CI: 0.87-1.65), three to four times a week (OR = 0.82, 95% CI: 0.62-1.10), or most days (OR = 0.94, 95% CI: 0.70-1.25) increased their risk of developing NHL. Average daily volume or high occasional alcohol consumption were not associated with NHL. CONCLUSIONS: NHL was not associated with smoking or alcohol, but collaborative studies could further investigate the risks of rarer WHO subtypes following these exposures.

The problem with measuring patient perceptions of outcome with existing outcome measures in foot and ankle surgery.

Quality outcome measures are the cornerstone of clinical research. A review of outcome measures used in foot and ankle surgery research reveals that the issues of validity, reliability and responsiveness of outcome measures have not been addressed. Most reports in the literature have attempted to evaluate patient perceptions of outcome following foot surgery. Underlying the many difficulties with these outcome measures is a lack of understanding of what patients perceive to be important in terms of outcome. Consequently none of the existing outcome measures can claim to be valid measures of patient perceptions of outcome, as there has been no research uncovering these perceptions. In addition, measures of general health status and quality of life in relation to outcome of foot and ankle surgery have been largely ignored to date.