Working With Human Research Protections

PURPOSE: To provide a primer for novice nurse scientists about the increasingly regulated human research environment. ORGANIZING CONSTRUCTS: Federal regulations and international guidelines about protection of human research participants are discussed, with particular attention to institutional review boards for human research. CONCLUSION: Understanding the processes used by institutional review boards to foster ethical human research promotes collaborative interactions and supports compliant research work.     

Two-year randomized controlled trial of vitamin K1 (phylloquinone) and vitamin D3 plus calcium on the bone health of older women.

Dietary supplementation with vitamin K(1), with vitamin D(3) and calcium or their combination, was examined in healthy older women during a 2-year, double-blind, placebo-controlled trial. Combined vitamin K with vitamin D plus calcium was associated with a modest but significant increase in BMC at the ultradistal radius but not at other sites in the hip or radius. INTRODUCTION: The putative beneficial role of high dietary vitamin K(1) (phylloquinone) on BMD and the possibility of interactive benefits with vitamin D were studied in a 2-year double-blind, placebo-controlled trial in healthy Scottish women > or =60 years of age. MATERIALS AND METHODS: Healthy, nonosteoporotic women (n = 244) were randomized to receive either (1) placebo, (2) 200 microg/day vitamin K(1), (3) 10 microg (400 IU) vitamin D(3) plus 1000 mg calcium/day, or (4) combined vitamins K(1) and D(3) plus calcium. Baseline and 6-month measurements included DXA bone mineral scans of the hip and wrist, markers of bone turnover, and vitamin status. Supplementation effects were tested using multivariate general linear modeling, with full adjustment for baseline and potential confounding variables. RESULTS: Significant bone mineral loss was seen only at the mid-distal radius but with no significant difference between groups. However, women who took combined vitamin K and vitamin D plus calcium showed a significant and sustained increase in both BMD and BMC at the site of the ultradistal radius. Serum status indicators responded significantly to respective supplementation with vitamins K and D. Over 2 years, serum vitamin K(1) increased by 157% (p < 0.001), the percentage of undercarboxylated osteocalcin (%GluOC) decreased by 51% (p < 0.001), serum 25-hydroxyvitamin D [25(OH)D] increased by 17% (p < 0.001), and PTH decreased by 11% (p = 0.049). CONCLUSIONS: These results provide evidence of a modest synergy in healthy older women from nutritionally relevant intakes of vitamin K(1) together with supplements of calcium plus moderate vitamin D(3) to enhance BMC at the ultradistal radius, a site consisting of principally trabecular bone. The substantial increase in gamma-carboxylation of osteocalcin by vitamin K may have long-term benefits and is potentially achievable by increased dietary intakes of vitamin K rather than by supplementation.     

Fear of falling in older adults: a guide to its prevalence, risk factors, and consequences.

Fear of falling, defined as a lack of self-confidence that one may avoid falls while doing everyday activities, may have serious consequences for elderly people. This article examines the prevalence, risk factors, and consequences of fear of falling in the elderly population; methods for assessing those fears; and suggests evidence-based interventions. Incorporating successful strategies into programs to reduce falling can result in improved patient outcomes as well as decreased healthcare utilization and costs.     

Experienced clinical educators improve their clinical teaching effectiveness.

OBJECTIVES: To determine if experienced clinical educators (CEs) can improve their teaching by incorporating 4 literature-based teaching methods into their instruction. METHODS: We trained 7 experienced CEs on the teaching methods during a monthly faculty development program. Each CE recorded use of these methods during 10 months on a personal digital assistant. We compared the CEs' teaching evaluations with those of nonparticipating faculty by analysis of variance at baseline, during the study period, and for 1 year after the study. RESULTS: Reported use of 2 teaching methods (priming and feedback) increased significantly over use at baseline; use of 2 other methods (teaching in the patient's presence and 1-2 focal teaching points) remained constant. Scores on the CEs' teaching evaluations were significantly higher during the study period on 1 item, whereas the comparison group showed no changes. The changes persisted during the follow-up period. CEs reported that the teaching methods focused the learner and teacher, making subsequent encounters more productive. They also found that the act of entering data daily prompted them to reflect on their teaching. CONCLUSIONS: Experienced teachers can be persuaded to incorporate new methods into their daily teaching. Reflection on teaching is enhanced with group support and daily reminders. With these interventions, teaching effectiveness of these experienced educators improved.     

Effect of a Low-Cost Intervention on Recording Body Mass Index in Patients'' Records

PURPOSE: Evaluate the effectiveness of body mass index (BMI) tables placed in exam rooms as an intervention to encourage providers to calculate and record BMI scores in patients' medical records. DESIGN: In a prospective cohort design, medical record data for 276 adult patients at a federally funded community health center in New England were examined from August 2000 to August 2002 following the intervention. METHODS: Prominent, multicolored, laminated BMI tables were posted in the exam rooms of one of the study site's three primary health care teams. Medical record data collected included documentation of BMI calculation in medical records, documentation of an obesity diagnosis, and inclusion of heights and current weights. Frequency distributions were calculated; chi-square tests were used to identify associations. FINDINGS: In contrast to the comparison teams, patients on the intervention team were more likely to have BMI recorded in the medical record. A statistically significant increase in the diagnosis of obesity was observed throughout the health center after the intervention. CONCLUSIONS: Posting BMI tables in exam rooms contributed to increased BMI documentation in patients' medical records.