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Gerarda Darlington

Publications and source records attributed to Gerarda Darlington.

5 recordsLinked to original sources

Methods for modelling change in cluster randomization trials.

Randomized trials are often designed to assess an intervention's ability to change patient knowledge, behaviour or health. The study outcome will then need to be measured at least twice for each subject--prior to random assignment and following implementation of the intervention. In this paper we consider methods for modelling change when data are obtained from cluster randomization trials where the unit of allocation is a family, school or community. Attention focuses on mixed effects linear regression extensions of (i) two-sample t-tests and (ii) analysis of covariance, in both cases accounting for dependencies among cluster members. Algebraic expressions for tests of the intervention effect are derived for the special case where there are a fixed number of subjects per cluster while simulation studies are used to compare the power of these procedures in the more realistic case where there is variability in cluster size. A key conclusion is that there can be considerable gains in power when allowing for different individual-level and cluster-level associations between the baseline and follow-up assessments. The discussion is illustrated using data from a school-based smoking prevention trial.

Canada↗

Medical history, sexual, and maturational factors and prostate cancer risk.

PURPOSE: Sexual, physical, and medical factors were investigated in a case-control study of prostate cancer. METHODS: This population-based study, conducted from 1995 to 1999 in northeastern Ontario, used cancer registry-identified cases (n=760), aged 45 to 84 years, diagnosed between 1995 and 1998. Age-frequency matched controls (n=1632) were obtained from telephone listings. Two separate logistic regression analyses considered: 1) sexual and physical; and 2) medical factors. RESULTS: For the sexual-physical model, marital status, family income, maximum height, number of marriages, having children, age at first marriage, birth, and needing to shave, and acne were not significantly related to risk. In the medical model, a family history of prostate cancer (OR, 2.99; 95% CI, 2.21-4.04) and history of venereal disease (OR, 2.12; 95% CI, 1.27-3.53) were associated with significantly increased risk. A history of allergies (OR, 0.78; 95% CI, 0.60-1.00), benign prostatic hyperplasia (OR, 0.63; 95% CI, 0.49-0.81), and an annual physical exam (OR, 0.43; 95% CI, 0.21-0.85) were associated with reduced risk. Other factors considered in the medical conditions model, body mass index, smoking non-filter cigarettes, and family income were not associated with prostate cancer. CONCLUSIONS: This study is consistent with other studies that suggest that infectious agents may be involved in prostate cancer development.

Age Factors↗

Effects of a relationship-enhancing program of care on outcomes.

PURPOSE: To examine the effects of a relationship-enhancing program of care (REPC) on resident and care provider outcomes. DESIGN AND METHODS: A quasi-experimental, repeated measures design, with intervention and comparison groups. Questionnaires were distributed to 50 residents, and observations were conducted of 40 residents and 34 nursing staff at baseline and 3 months after the intervention, on two Canadian nursing home units. An investigator-designed educational program based on Winnicott's theory of relationships and the empirical literature, was provided to care providers and their supervisors on the intervention unit. Repeated measures analysis of variance (RM-ANOVA) was used to compare the intervention and comparison groups in regard to changes in the outcomes over time. FINDINGS: The REPC had statistically significant effects on (a) residents' perceptions of care providers' relational care, (b) care providers' relational behaviors, and (c) continuity of care. CONCLUSIONS: Evidence showed that these care providers were taught how to enhance their relational skills with residents living in long-term care facilities without added staff. Recommendations for practice and research are discussed.

Adult↗

Efficacy and safety of sucrose for procedural pain relief in preterm and term neonates.

BACKGROUND: Preterm and acutely ill term neonates who are hospitalized in a neonatal intensive care unit are subjected to multiple frequent invasive and painful procedures aimed at improving their outcome. Although several trials to determine the efficacy of sucrose for managing procedural pain in preterm and acutely ill term neonates have been developed, these have generally lacked methodological rigor and have not provided clinicians with clear practice guidelines. OBJECTIVES: To compare the efficacy and safety of three interventions for relieving procedural pain associated with heel lances in preterm and term neonates, and to explore the influence of contextual factors including sex, severity of illness, and prior painful procedures on pain responses. METHODS: In a randomized controlled trial, 190 neonates were stratified by gestational age and then randomized to receive (a) sucrose and nonnutritive sucking (n = 64), (b) sucrose alone (n = 62), or (c) sterile water and nonnutritive sucking (control) (n = 64) to evaluate the efficacy (pain response as measured using the Premature Infant Pain Profile) (Stevens, Johnson, Petryshen, & Taddio, 1996) and safety (adverse events) following a scheduled heel lance during the first week of life. Stratification was used to control for the effects of age on pain response. RESULTS: Significant differences in pain response existed among treatment groups (F = 22.49, p <.001), with the lowest mean Premature Infant Pain Profile scores in the sucrose and nonnutritive sucking group. Efficacy of sucrose following a heel lance was not affected by severity of illness, postnatal age, or number of painful procedures. Intervention group and sex explained 12% of the variance in Premature Infant Pain Profile scores. Few adverse events occurred (n = 6), and none of them required medical or nursing interventions. CONCLUSIONS: The combination of sucrose and nonnutritive sucking is the most efficacious intervention for single heel lances. Research on the effects of gestational age on the efficacy and safety of repeated doses of sucrose is required.

Analysis of Variance↗