Best Practices to Support the Self-Determination of Indigenous Communities, Collectives, and Organizations in Health Research through a Provincial Health Research Network Environment in British Columbia, Canada.

In Canada, the health research funding landscape limits the self-determination of Indigenous peoples in multiple ways, including institutional eligibility, priority setting, and institutional structures that deprioritize Indigenous knowledges. However, Indigenous-led research networks represent a promising approach to transforming the funding landscape to better support the self-determination of Indigenous peoples in health research. The British Columbia Network Environment for Indigenous Health Research (BC NEIHR) is one of nine Indigenous-led networks across Canada that supports research leadership among Indigenous (First Nations, Métis, and Inuit) communities, collectives, and organizations (ICCOs). In this paper, we share three best practices to support the self-determination of ICCOs in health research based on three years of operating the BC NEIHR: (1) creating capacity-bridging initiatives to overcome funding barriers; (2) building relational research relationships with ICCOs ("people on the ground"); and (3) establishing a network of partnerships and collaborations to support ICCO self-determination. Supporting the self-determination of ICCOs and enabling them to lead their own health research is a critical pathway toward transforming the way Indigenous health research is funded and conducted in Canada.

Choral singing and dementia: Exploring musicality as embodied and relational accomplishment.

This study explored the impact of participation in Voices in Motion (ViM), an intergenerational community choir program that involved persons with dementia, care partners, and high school students in Victoria, British Columbia, Canada. Data came from interviews with 23 duets, each consisting of a person with dementia and their care partner; additionally, five focus groups with 29 students across two ViM choirs were conducted. Choir rehearsals and concerts were also observed. The analysis revealed that those with dementia have an embodied ability to fully participate in the choir and perform songs despite cognitive decline and memory loss. Involvement in the choirs also facilitated the emergence of strong social relationships among participants while students reported gaining a deeper understanding of the everyday experiences of living with dementia. Through well-attended concerts and performances at public events, ViM also helped re-humanize persons living with dementia by challenging the narrative of decline and its associated stigma.

Efficacy and safety of loteprednol etabonate 0.5% gel in the treatment of ocular inflammation and pain after cataract surgery.

PURPOSE: To examine the efficacy and safety of a new gel formulation loteprednol etabonate 0.5% in the treatment of inflammation and pain after cataract surgery. SETTING: Seventeen United States clinical sites. DESIGN: Prospective double-masked parallel-group study. METHODS: Patients with anterior chamber cell (ACC) grade 2 or higher after cataract surgery were randomized to loteprednol etabonate 0.5% gel or vehicle 4 times a day for 14 days. Primary outcome measures included the proportion of patients with complete resolution of ACC and grade 0 (no) pain on postoperative day 8. Safety measures included adverse events, intraocular pressure (IOP), visual acuity, biomicroscopy and funduscopy findings, and tolerability (ocular symptoms and drop comfort). RESULTS: The intent-to-treat population included 406 patients (203 per treatment). On day 8, 30.5% of patients in the loteprednol etabonate group and 16.3% of patients in the vehicle group had complete resolution of ACC, whereas 72.9% and 41.9%, respectively, had grade 0 pain (both P<.001). Significant treatment differences for complete resolution of ACC and grade 0 pain favoring loteprednol etabonate were also found on day 15 and day 18. One patient in each treatment group had a significant increase in IOP (≥ 10 mm Hg). Analyses of pain, photophobia, and tearing favored loteprednol etabonate at different time points beginning on day 3. More than 85% of patients in each treatment group reported no discomfort on drop instillation. CONCLUSION: Loteprednol etabonate gel 0.5% was efficacious and safe in treating postoperative inflammation and pain. FINANCIAL DISCLOSURE: Dr. Rajpal is a consultant to Bausch & Lomb, Inc., Allergan, Inc., and Alcon Laboratories, Inc. Dr. Siou-Mermet and Ms. Erb are employees of Bausch & Lomb, Inc. Dr. Roel has no financial or proprietary interest in any material or method mentioned.

Loteprednol etabonate gel 0.5% for postoperative pain and inflammation after cataract surgery: results of a multicenter trial.

PURPOSE: Loteprednol etabonate (LE) is approved by the US FDA in a suspension and ointment form (0.5%) for the treatment of postoperative ocular inflammation. This study examined the gel formulation of LE, an improved, nonsettling formulation with a lower preservative level and a more physiologic pH. PATIENTS AND METHODS: This multicenter, double-masked, parallel-group, vehicle-controlled study randomized patients aged ≥18 years with postoperative anterior chamber cell (ACC) ≥ grade 2 following uncomplicated cataract surgery to either LE gel or vehicle four times a day for 14 days. Primary efficacy end points included the proportion of patients with complete resolution of ACC and grade 0 (no) pain by postoperative day 8. Secondary efficacy end points included complete resolution and change from baseline in ACC and flare (individual and combined), and grade 0 pain at each visit. Safety end points included treatment-emergent adverse events, ocular symptoms, changes in intraocular pressure (IOP) and visual acuity, and biomicroscopy and funduscopy findings. RESULTS: A total of 407 patients were randomized to treatment (n = 206, LE gel; n = 201, vehicle). At day 8, 31.1% (64) of LE-treated patients and 13.9% (28) of vehicle-treated patients had complete resolution of ACC (P < 0.001), and 75.7% (156) of LE-treated patients and 45.8% (92) of vehicle-treated patients had grade 0 pain (P < 0.001). Secondary efficacy end points also favored LE gel. Fewer patients treated with LE gel required rescue medication (10.7% versus 42.3%) prior to day 15, and fewer had an ocular adverse event (16.0% versus 28.9%, P = 0.002). No drug-related adverse effects were reported more than once in the LE group. Mean IOP decreased in both treatment groups; one patient in the LE group demonstrated a clinically significant increase (≥10 mm Hg) in IOP that was not considered drug-related. Visual acuity and funduscopy findings were similar between treatments. CONCLUSION: LE gel 0.5% was efficacious and safe in treating postoperative inflammation and pain in this clinical study.

Safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery.

BACKGROUND: To compare the safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% (LE ointment), a new topical ointment formulation, with vehicle for the treatment of inflammation and pain following cataract surgery. METHODS: Two randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies were conducted. Patients aged ≥18 years with a combined postoperative anterior chamber cells and flare (ACI) ≥ Grade 3 following uncomplicated cataract surgery participated in seven study visits. Patients self-administered either topical LE ointment or vehicle four times daily for 14 days. Efficacy outcomes included the proportion of patients with complete resolution of ACI and the proportion of patients with no (Grade 0) pain at postoperative day 8. Safety outcomes included the incidence of adverse events, ocular symptoms, changes in intraocular pressure and visual acuity, and biomicroscopy and funduscopy findings. RESULTS: Data from the two studies were combined. The integrated intent-to-treat population consisted of 805 patients (mean [standard deviation] age 69.0 [9.2] years; 58.0% female and 89.7% white). Significantly more LE ointment-treated patients than vehicle-treated patients had complete resolution of ACI (27.7% versus 12.5%) and no pain (75.5% versus 43.1%) at day 8 (P < 0.0001 for both). Fewer LE ointment-treated patients required rescue medication (27.7% versus 63.8%), and fewer had an ocular adverse event (47.2% versus 78.0%, P < 0.0001) while on study treatment. The most common ocular adverse events with LE ointment were anterior chamber inflammation, photophobia, corneal edema, conjunctival hyperemia, eye pain, and iritis. Mean intraocular pressure decreased in both treatment groups. Four patients had increased intraocular pressure ≥10 mmHg (three LE ointment and one vehicle) prior to rescue medication. Visual acuity and dilated funduscopy results were similar between the treatment groups, with the exception of visual acuity at visits 5 and 6, which favored LE ointment. CONCLUSION: LE ointment was efficacious and well tolerated in the treatment of ocular inflammation and pain following cataract surgery.

Multipurpose solutions and rates of biocidal efficacy.

OBJECTIVE: To investigate the hypothesis that reasonable levels of disinfection are achievable over relatively short exposure durations of microorganisms to multipurpose solutions, this study examined the stand-alone disinfection efficacy at 10, 20, and 30 min of five different multipurpose solutions products, each against five different pathogens eye care practitioners may encounter in their contact lens practice. METHODS: ReNu MultiPlus, ReNu Multi-Purpose, AQuify, OptiFree Express, and OptiFree RepleniSH were evaluated for their microbiocidal efficacy using the stand-alone method at 10, 20, and 30 min of exposure to either Fusarium solani, Candida albicans, Staphylococcus aureus, Serratia marcescens, or Pseudomonas aeruginosa. RESULTS: Solutions which showed significantly higher rates of disinfection at 30 min were ReNu MultiPlus against Fusarium solani and Candida albicans, and both ReNu MultiPlus and AQuify against Staphylococcus aureus and Serratia marcescens. There were no statistically significant differences at 30 min amongst solutions against Pseudomonas aeruginosa. CONCLUSIONS: The product attribute of rapid rate of disinfection may give a greater level of assurance to practitioners when patients are noncompliant and do not follow the recommended time period for lens disinfection. The results of this study, however, should not be interpreted as a recommendation to use any of the solutions tested for a disinfection period less than the recommended soak time. Patient compliance with recommended lens care regimens is essential in minimizing the risk of contamination of contact lenses and lens care accessories.

Pharmacokinetics of indinavir and ritonavir administered at 667 and 100 milligrams, respectively, every 12 hours compared with indinavir administered at 800 milligrams every 8 hours in human immunodeficiency virus-infected patients.

Human immunodeficiency virus (HIV) patients on nucleoside or nucleotide reverse transcriptase inhibitors with HIV RNA at <1,000 copies/ml were randomized in an open-label study to administration of combined indinavir/ritonavir (IDV/RTV) at 667/100 mg every 12 h (q12h) or IDV alone at 800 mg q8h to determine the regimens' pharmacokinetics. On day 14, plasma IDV and RTV levels were determined over 24 h. Noncompartmental pharmacokinetics (minimum concentration of drug in serum [C(min)], area under the concentration-time curve from 0 to 24 h [AUC(0-24)], and maximum concentration of drug in serum [C(max)]) were expressed as geometric mean values with 90% confidence intervals (CI). The primary hypothesis was that the lower bound of the protocol-specified 90% CI for the geometric mean C(min) ratio of the combination compared to IDV alone regimen would be >/=2. Twenty-seven patients were enrolled, and 24 (15 male; average age, 42 years) completed the study. The C(min), AUC(0-24), and C(max) for IDV/RTV compared to IDV alone were 1,511 versus 250 nM, 119,557 versus 77,034 nM . h, and 10,428 versus 10,407 nM, respectively. Corresponding relationships for IDV/RTV compared to IDV alone were a 6.0-fold increase in C(min) (90% CI, 4.0, 9.3), an increase in AUC(0-24) (1.5-fold, 90% CI, 1.2, 2.0), and no increase in C(max). Adverse events were similar and generally mild, with no cases of nephrolithiasis. The geometric mean ratio of IDV C(min) for IDV/RTV compared to IDV was at least 2 by a lower bound of the 90% CI, satisfying the primary hypothesis. The C(max) was not increased, suggesting an IDV/RTV 667/100-mg toxicity profile may be similar to that of unboosted IDV.

The analgesic efficacy of etoricoxib compared with oxycodone/acetaminophen in an acute postoperative pain model: a randomized, double-blind clinical trial.

Our objective in this study was to compare the analgesic effects of etoricoxib and oxycodone/acetaminophen in a postoperative dental pain model. Patients experiencing moderate to severe pain after extraction of two or more third molars were randomized to single doses of etoricoxib 120 mg (n = 100), oxycodone/acetaminophen 10/650 mg (n = 100), or placebo (n = 25). The primary end-point was total pain relief over 6 h. Other end-points included patient global assessment of response to therapy; onset, peak, and duration of effect; and rescue opioid analgesic use. Active treatments were statistically significantly superior to placebo for all efficacy measures. Total pain relief over 6 h for etoricoxib was significantly more than for oxycodone/acetaminophen (P < 0.001). Patient global assessment of response to therapy at 6 and 24 h was superior for etoricoxib. Both drugs achieved rapid onset, although the time was faster for oxycodone/acetaminophen by 5 min. The peak effect was similar for both drugs. Compared with oxycodone/acetaminophen patients, etoricoxib patients experienced a longer analgesic duration, had a smaller percentage requiring rescue opioids during 6 and 24 h, and required less rescue analgesia during 6 and 24 h. Oxycodone/acetaminophen treatment resulted in more frequent adverse events (AEs), drug-related AEs, nausea, and vomiting compared with etoricoxib treatment. In conclusion, etoricoxib 120 mg provided superior overall efficacy compared with oxycodone/acetaminophen 10/650 mg and was associated with significantly fewer AEs.

Application of Bayes theorem to aminoglycoside-associated nephrotoxicity: comparison of extended-interval dosing, individualized pharmacokinetic monitoring, and multiple-daily dosing.

The objective of this study was to examine the incidence of aminoglycoside-associated nephrotoxicity related to extended-interval dosing, individualized pharmacokinetic monitoring, and multiple-daily dosing by applying Bayes theorem. An electronic literature search of MEDLINE (1966-2003) and a manual search of references from published meta-analyses and review articles were performed. Studies using extended-interval dosing, individualized pharmacokinetic monitoring, or multiple-daily dosing and reported aminoglycoside-associated nephrotoxicity for patients > or = 16 years of age were included. Quality scores were assigned based on the rigor of definition of aminoglycoside-associated nephrotoxicity, duration of therapy, and length of follow-up of renal function after completion of therapy. Inclusion criteria were then based on these quality scores. Quantitative data on the incidence of aminoglycoside-associated nephrotoxicity were abstracted. Twelve extended-interval dosing studies (n = 916), 10 individualized pharmacokinetic monitoring studies (n = 2066), and 27 multiple-daily dosing studies (n = 4251) met the inclusion criteria. Prior probabilities of aminoglycoside-associated nephrotoxicity were derived from a combination of a review of published studies and expert judgment. The maximum densities for the final posterior probabilities of aminoglycoside-associated nephrotoxicity for extended-interval dosing, individualized pharmacokinetic monitoring, and multiple-daily dosing were located at 12% to 13%, 10% to 11%, and 13% to 14%, respectively. Application of Bayes theorem demonstrates that aminoglycoside dosing by individualized pharmacokinetic monitoring results in less aminoglycoside-associated nephrotoxicity than extended-interval dosing or multiple-daily dosing.

Television viewing and television in bedroom associated with overweight risk among low-income preschool children.

CONTEXT: Television (TV) viewing is associated with obesity among school-aged children, adolescents, and adults, but this relationship has not been evaluated in preschool-aged children. OBJECTIVE: To describe the TV/video viewing habits of a multiethnic, low-income preschool population of children and to determine whether TV/video viewing is related to their adiposity. DESIGN: Cross-sectional survey of parents/guardians with measurements of children's height and weight. SETTING AND PARTICIPANTS: Two thousand seven hundred sixty-one adults with children, 1 through <5 years, from 49 New York State agencies of the Supplemental Nutrition Program for Women, Infants, and Children. OUTCOME MEASURES: Cross-sectional relationships between the amount of time the child spends viewing TV/video and the presence of a TV set in the child's bedroom, with the prevalence of overweight children (body mass index [BMI] >85th percentile) after adjustment for potential confounders. RESULTS: Mean TV/video viewing times were higher among black children and Hispanic children than white children and increased with the child's age. In multiple logistic regression, the odds ratio of children having a BMI >85th percentile was 1.06 (95% confidence interval [CI]: 1.004-1.11) for each additional hour per day of TV/video viewed, independent of child age, child sex, parental educational attainment, and race/ethnicity. Almost 40% of children had a TV set in their bedroom; they were more likely to be overweight and spent more time (4.6 hours per week) watching TV/video than children without a TV in their bedroom. In multiple logistic regression, the odds ratio of having a BMI >85th percentile was 1.31 (95% CI: 1.01-1.69) among those with a TV in their bedroom versus those without a TV, after statistical adjustment for child age, child sex, child TV/video viewing hours per week, maternal BMI, maternal education, and race/ethnicity. CONCLUSIONS: This study extends the association between TV viewing and risk of being overweight to younger, preschool-aged children. A TV in the child's bedroom is an even stronger marker of increased risk of being overweight. Because most children watch TV by age 2, educational efforts about limiting child TV/video viewing and keeping the TV out of the child's bedroom need to begin before then.

An occupational health nursing education program. Relevance to nurses in nonoccupational practice settings.

A collaborative effort between community health faculty in an upper division nursing program and nurses from a nearby agricultural health and research center resulted in an educational program focused on occupational health and safety issues in the agricultural industry. The 3 hour class was presented each semester between 1997 and 1999 to RN students enrolled in a community health organization class. In addition to information about the health and safety hazards in agriculture, the nursing students learned about the center's research projects and clinical services available to the farming community. A follow up survey was mailed to the nursing students to evaluate the effectiveness and relevance of the occupational health program by identifying the proportion of the nurses' caseloads spent on occupational health problems, and whether the information and materials presented in the class were relevant to practice. Results showed that even though the surveyed nurses were employed in nonoccupational practice settings, nearly everyone rated the occupational health information as useful. Findings also revealed that although nurses in nonoccupational practice can spend nearly a quarter of their time caring for clients with work related health problems, they may lack adequate educational preparation to do so.