Validation of a Patient-Reported Outcome Measure for Moist Desquamation among Breast Radiotherapy Patients

There has been an increasing interest in patient-reported outcome (PRO) measures in both the clinical and research settings to improve the quality of life among patients and to identify when clinical intervention may be needed. The primary purpose of this prospective study was to validate an acute breast skin toxicity PRO measure across a broad sample of patient body types undergoing radiation therapy. Between August 2018 and September 2019, 134 women undergoing adjuvant breast radiotherapy (RT) consented to completing serial PRO measures both during and post-RT treatment and to having their skin assessed by trained trial radiation therapists. There was high patient compliance, with 124 patients (92.5%) returning to the clinic post-RT for at least one staff skin assessment. Rates of moist desquamation (MD) in the infra-mammary fold (IMF) by PRO were compared with skin assessments completed by trial radiation therapists. There was high sensitivity (86.5%) and good specificity (79.4%) between PRO and staff-reported presence of MD in the IMF, and there was a moderate correlation between the peak severity of the MD reported by PRO and assessed by staff (rho = 0.61, p < 0.001). This prospective study validates a new PRO measure to monitor the presence of MD in the IMF among women receiving breast RT.     

Differential effects of propranolol on lymphocyte rosette formation and response to plant mitogens

The effects of propranolol on various lymphocyte functions were studied to gain a better understanding of the recently demonstrated suppressive effect of propranolol on rheumatoid factor production. D- and L-propranolol at a concentration of 1 X 10⁻⁴ M inhibited the formation of human EA rosettes. The inhibition occurred within one minute of adding the compounds, was reversible, and did not affect cell viability. Addition of propranolol to preformed EA rosettes failed to disaggregate them. Patching and capping of SIg by an Fab′2 anti-IgG were inhibited at 2.5 X 10⁻⁵M and above. Propranolol at 2.5 X 10⁻⁵M also inhibited lymphocyte response to phytohemagglutinin and pokeweed mitogen without evidence of cell toxicity by trypan blue staining or absolute numbers of surviving cells. Congeners of propranolol with mainly beta adrenergic blocking properties did not show inhibitory effects. The inhibitory activities of propranolol are interpreted in terms of propranolol's membrane stabilizing effects and ability to interfere with membrane receptor movement.     

Plant Thorn Synovitis

Five children with an inflammatory monarthritis due to penetration of the joint by plant thorns are presented. The clinical presentation was that of a transient acute synovitis followed by a relatively asymptomatic period, and later by chronic arthritis often after the thorn injury was forgotten. Histopathology demonstrated a granulomatous synovitis. Polarized light microscopy facilitated identification of the plant tissue within the synovium. Conservative medical therapy was ineffective, but surgical excision of the affected synovium resulted in normal joint function. The differential diagnosis of monarthritis in children is extensive, and awareness of this condition is necessary to elicit a comprehensive history and to avoid delay in treatment.     

Acute gouty arthritis without urate crystals identified on initial examination of synovial fluid

Nine patients who ultimately proved to have acute gouty arthritis did not have urate crystals demonstrable by compensated polarized light in the first joint fluid aspirated despite leukocyte counts as high as 100,000/mm³. In 6 cases crystals were found in fluid from the same joint 5 hours to 1 day later. Factors that might explain the difficulty in identifying crystals include aspiration of the wrong site because diffuse swelling obscured predominant involvement of a bursa or adjacent small joint, loculation within a joint, crystal dissolution leaving only tiny birefringent chunks, and inexpert or insufficient search. Some cases remain without any tentative explanation. The possibility of acute gouty arthritis should not be excluded if crystals are not demonstrable in the first search of joint fluid. Repeated searches for typical monosodium urate crystals may be required for diagnosis.     

A benefit/risk approach towards selecting appropriate pharmaceutical dosage forms - An application for paediatric dosage form selection

The design and selection of new pharmaceutical dosage forms involves the careful consideration and balancing of a quality target product profile against technical challenges and development feasibility. Paediatric dosage forms present particular complexity due to the diverse patient population, patient compliance challenges and safety considerations of this vulnerable population. This paper presents a structured framework for assessing the comparative benefits and risks of different pharmaceutical design options against pre-determined criteria relating to (1) efficacy, (2) safety and (3) patient access. This benefit/risk framework has then been applied to three hypothetical, but realistic, scenarios for paediatric dosage forms in order to explore its utility in guiding dosage form design and formulation selection. The approach allows a rigorous, systematic and qualitative assessment of the merits and disadvantages of each dosage form option and helps identify mitigating strategies to modify risk. The application of a weighting and scoring system to the criteria depending on the specific case could further refine the analysis and aid decision-making. In this paper, one case study is scored for illustrative purposes. However, it is acknowledged that in real development scenarios, the generation of actual data considering the very specific situation for the patient/product/developer would come into play to drive decisions on the most appropriate dosage form strategy.     

Acceptability of Potential Rectal Microbicide Delivery Systems for HIV Prevention: A Randomized Crossover Trial

We assessed the acceptability of three of over-the-counter products representative of potential rectal microbicide (RM) delivery systems. From 2009 to 2010, 117 HIV-uninfected males (79 %) and females (21 %) who engage in receptive anal intercourse participated in a 6-week randomized crossover acceptability trial. Participants received each of three products (enema, lubricant-filled applicator, suppository) every 2 weeks in a randomized sequence. CASI and T-ACASI scales assessed product acceptability via Likert responses. Factor analysis was used to identify underlying factors measured by each scale. Random effects models were fit to examine age and gender effects on product acceptability. Three underlying factors were identified: Satisfaction with Product Use, Sexual Pleasure, and Ease of Product Use. For acceptability, the applicator ranked highest; however, differences between product acceptability scores were greatest among females and younger participants. These findings indicate that RM delivery systems impact their acceptability and should be considered early in RM development to enhance potential use.     

The effects of suggestions of altertness in hypnosis on pupillary response: Report on a single subject

The pupil size of a single S was recorded under 2 types of hypnotic suggestion: alertness instructions and traditional relaxation instructions. It was found that the size of the pupil increased significantly under alertness instructions. This result was taken as further corroboration of the hypothesis that changes in various parameters of arousal apparently associated with hypnosis may be attributed to specifiable characteristics of the instructions used rather than to stable characteristics of the “state” of hypnosis.