A Canadian Prospective Study of Linkage of Randomized Clinical Trial to Cancer and Mortality Registry Data

In a prospective study, we sought to determine acceptability of linkage of administrative and clinical trial data among Canadian patients and Research Ethics Boards (REBs). The goal is to develop a more harmonized approach to data, with potential to improve clinical trial conduct through enhanced data quality collected at reduced cost and inconvenience for patients. On completion of the original LY.12 randomized clinical trial in lymphoma ({"type":"clinical-trial","attrs":{"text":"NCT00078949","term_id":"NCT00078949"}}NCT00078949), participants were invited to enrol in the Long-term Innovative Follow-up Extension (LIFE) component. Those consenting to do so provided comprehensive identifying information to facilitate linkage with their administrative data. We prospectively designed a global assessment of this innovative approach to clinical trial follow-up including rates of REB approval and patient consent. The pre-specified benchmark for patient acceptability was 80%. Of 16 REBs who reviewed the research protocol, 14 (89%) provided approval; two in Quebec declined due to small patient numbers. Of 140 patients invited to participate, 115 (82%, 95% CI 76 to 88%) from across 9 Canadian provinces provided consent and their full name, date of birth, health insurance number and postal code to facilitate linkage with their administrative data for long-term follow-up. Linkage of clinical trial and administrative data is feasible and acceptable. Further collaborative work including many stakeholders is required to develop an optimized secure approach to research. A more coordinated national approach to health data could facilitate more rapid testing and identification of new effective treatments across multiple jurisdictions and diseases from diabetes to COVID-19.     

Exposure to bisphenol A from bis-glycidyl dimethacrylate-based dental sealants

BACKGROUND: Bisphenol A (BPA) is a common component of composites and dental sealants. The potential exists for human exposure after sealant placement. METHODS: The authors prospectively enrolled 15 men in an exposure assessment study; 14 completed the study. After placement of clinically appropriate amounts of one of two sealants, the authors measured BPA in saliva and urine samples collected at prescribed intervals after the sealants were placed. They used selective and sensitive isotope-dilution mass-spectrometry-based methods for BPA measurements, thus providing the most reliable results. RESULTS: Helioseal F (Ivoclar Vivadent, Amherst, N.Y.) leached negligible amounts of BPA. Urinary and salivary BPA levels in subjects who received these sealants were similar to baseline levels. Delton Light Cure (LC) Opaque pit-and-fissure sealant (Dentsply/Ash, York, Pa.) leached more BPA, resulting in low-level BPA exposures similar to those used in laboratory animal testing. BPA exposure after Delton LC sealant placement was significantly higher than exposure after placement of Helioseal F. Patients treated with Delton LC had significantly higher doses of BPA (110 microg) than did those treated with Helioseal F (5.5 microg) (P < .0001). CONCLUSIONS: Placement of clinically relevant amounts of Delton LC sealant resulted in low-level BPA exposure; however, exposure was negligible after placement of Helioseal F. Saliva collection after sealant placement likely reduced systemic absorption of BPA from dental sealants. Sealants should remain a useful part of routine preventive dental practice, especially those that leach negligible amounts of BPA. CLINICAL IMPLICATIONS: Dental sealants may be a point source for low-level BPA exposure at levels that show health effects in rodents. Further research is required to determine whether human exposure to BPA at these levels causes adverse effects.     

Rehabilitation therapy for patients with long-term spinal cord injuries

The functional effects of three types of therapy for subjects with long-term incomplete cervical spinal cord injuries were investigated. Men and women, aged 18 to 45 years, were assigned to one of four groups using a restricted randomization process. The training period was divided into two consecutive eight-week time blocks where subjects received either (1) supervised physical exercise therapy (PET), (2) neuromuscular stimulation (NMS), or (3) electromyographic (EMG) biofeedback. Group 1 received EMG biofeedback followed by PET; Group 2 received EMG biofeedback followed by NMS; Group 3 received NMS followed by PET; and Group 4 received 16 weeks of PET. Dependent measures (manual muscle tests, self-care scores, mobility measures, and voluntary EMG activity) were assessed before training, at eight weeks, and after 16 weeks of training. A significant improvement (p less than .05) across time was found on all dependent measures except voluntary EMG. No difference was found on comparisons between groups.     

Tick acquisition of Ehrlichia canis from dogs treated with doxycycline hyclate

Doxycycline generally alleviates clinical monocytic ehrlichiosis, but its efficacy in the control of monocytotropic ehrlichial pathogens requires further investigation. In this study, Ehrlichia canis was detected in dogs treated with doxycycline for 14 days and in ticks fed on these dogs, suggesting that treated dogs can remain reservoirs for E. canis.     

Cross‐sector emergency planning for water supply utilities and healthcare facilities

The purpose of this article is to outline the criticality of water supply in sustained operations of healthcare facilities, particularly during community emergencies, and to advocate for enhanced cross‐sector support from the water utilities in meeting this need. Information and ideas presented here were developed in the course of a regional project sponsored by the Metropolitan Washington Council of Governments (MWCOG) for development of emergency water supply operations plans for critical water uses in the Washington, DC, area.     

Formulation and Optimization of a Sustained-Release Tablet of Ketorolac Tromethamine

The objective of our study was to formulate a sustained-release tablet of Ketorolac tromethamine, which is a nonsteroidal anti-inflammatory agent. A 2 3 full factorial design (8 runs) was selected. The variables studied were the amount of drug (30 and 40 mg), ratio of hydroxypropyl methylcellulose (HPMC)/sodium carboxymethylcellulose (NaCMC) (240/40 and 140/140 mg), and amount of ethylcellulose (140 and 180 mg). Swelling-controlled matrix tablets were manufactured by direct compression of formulation ingredients using a Stokes single punch tablet press. Dissolution tests were performed using USP apparatus 3 (Bio-Dis II), at various pHs to mimic the conditions that exist in the gastrointestinal tract. Responses studied included time for 50% of the drug to dissolve (T 50), diffusional exponent (n) that characterizes the release mechanism, and percent friability of the tablets. Analysis of variance indicated that the release rate (T 50) was affected by the HPMC/NaCMC ratio, amount of drug, and two-way and three-way interactions; whereas the amount of drug, HPMC/NaCMC ratio, ethylcellulose, and the interaction between drug and HPMC/NaCMC and HPMC/NaCMC and ethylcellulose and also three-way interactions were significantly affecting the diffusional exponent (n) . The release mechanism was found to be super-case II transport. The friability of the tablets was significantly affected by all three factors: amount of drug, HPMC/NaCMC ratio, and amount of ethylcellulose. The formulation giving the best release characteristics was identified.     

Professional Demeanor of Chronically Unemployed Cocaine-Dependent Methadone Patients in a Therapeutic Workplace

This study assesses the frequency that users of illicit drugs display unprofessional behaviors in an employment setting. This research was conducted in the therapeutic workplace, a model employment-based treatment program for chronically unemployed adults with long histories of illicit drug use in 2003. Fifty-three unemployed adults in methadone treatment, who were opiate and cocaine dependent, showed signs of injection drug use, and recently used cocaine were hired to work for 4 hours every weekday for 7 months. Results show that while the overall incidence of many undesirable behaviors is low, a small percentage of participants had serious workplace behavior problems that might limit their success in community workplaces. This study suggests that unprofessional behavior in the workplace could contribute to chronic unemployment in this population. The study's limitations are noted and future needed research is suggested.     

The effect of a training course on nursing students' attitudes toward, perceptions of, and confidence in managing patient aggression

Patient aggression is a problem in many health care settings, and nursing students are among the most vulnerable to experiencing such aggression. Training courses have been suggested to help nurses better manage patient aggression. Such courses can lead to changes in attitudes toward and perceptions of, as well as greater confidence in managing, aggression. In this quasi-experimental study, we investigated the effect of a training course on nursing students' attitudes toward, perceptions of, and confidence in managing patient aggression. Students in the intervention group demonstrated enhanced confidence but no change in attitude after the training course, while students in the control group remained stable on all measures. The short time frame of the study, the training course itself, and the instruments used for monitoring attitudes toward aggression are possible reasons for these results. We tentatively conclude that it is possible to enhance nursing students' perceived confidence in managing patient aggression without changing their fundamental views of it.