Perceptions of the ethical conduct of cancer trials by oncology nurses.

Informed consent and subject protection are internationally mandated requirements for the ethical conduct of research; however, the monitoring of the day-to-day conduct of research may be insufficient for ensuring consistent compliance with required ethical ideals. Oncology nurses were surveyed about their perceptions of ethical issues relevant to cancer trials research. Utilising an investigator-developed instrument, multi-item scales assessed six ethical domains. Of 192 respondents, 95% or more held definite views in 12 of 15 items about patient understanding of cancer trials, informed consent and the welfare of participants. Approximately 95% perceived that patients consented freely and knew how to withdraw from a trial, and 81% perceived better monitoring of trial than non-trial patients. However, more than 80% of respondents perceived that at times patients had unrealistic expectations of participation, and more than 50% perceived that participants sometimes did not understand the nature and risk of cancer trials. Although the conative attributes of patients place limits on the goals of bioethics, the results of this study show first that oncology nurses have opinions about ethical constructs directly linked to the daily conduct of cancer clinical trials, and second that this link warrants further investigation in order to benchmark trial conduct against the ideals of ethical research.

An ethical approach to resolving value conflicts in child protection.

Child protection professionals working in diverse societies are regularly faced with value conflicts. Recognising these, and resolving them in the best interests of children, is a task that requires child protection specialists to make complex judgements and decisions. In this paper the philosophical concepts of absolutism and relativism to child abuse are applied, and it explores how this approach has practical relevance to solving ethical dilemmas in child protection. Children's interests are best served by erring towards an absolutist approach to the diagnosis and recognition of maltreatment and towards a relativistic approach in determining how services respond to a harmful incident or situation. Absolutism and relativism are not alternatives, but part of a continuous process of recognising and negotiating ever-changing community, national and global norms. At the service level the dichotomy transpires into the need to be culturally competent in handling the conflicting needs, rights and values of children, families, communities and professionals, whilst retaining the skill of child advocacy.

A systematic review of the features that indicate intentional scalds in children.

BACKGROUND: Most intentional burns are scalds, and distinguishing these from unintentional causes is challenging. AIM: To conduct a systematic review to identify distinguishing features of intentional and unintentional scalds. METHODS: We performed an all language literature search of 12 databases 1950-2006. Studies were reviewed by two paediatric/burns specialists, using standardised methodology. Included: Primary studies of validated intentional or accidental scalds in children 0-18 years and ranked by confirmation of intentional or unintentional origin. Excluded: neglectful scalds; management or complications; studies of mixed burn type or mixed adult and child data. RESULTS: 258 studies were reviewed, and 26 included. Five comparative studies ranked highly for confirmation of intentional/unintentional cause of injury. The distinguishing characteristics were defined based on best evidence. Intentional scalds were commonly immersion injuries, caused by hot tap water, affecting the extremities, buttocks or perineum or both. The scalds were symmetrical with clear upper margins, and associated with old fractures and unrelated injuries. Unintentional scalds were more commonly due to spill injuries of other hot liquids, affecting the upper body with irregular margins and depth. CONCLUSIONS: We propose an evidence based triage tool to aid in distinguishing intentional from unintentional scalds, requiring prospective validation.

One year of insulin-like growth factor I treatment does not affect bone density, body composition, or psychological measures in postmenopausal women.

The activity of the hypothalamic-GH-insulin-like growth factor I (hypothalamic-GH-IGF-I) axis declines with age, and some of the catabolic changes of aging have been attributed to the somatopause. The purpose of this investigation was to determine the impact of 1 yr of IGF-I hormone replacement therapy on body composition, bone density, and psychological parameters in healthy, nonobese, postmenopausal women over 60 yr of age. Subjects (n = 16, 70.6 +/- 2.0 yr, 71.8 +/- 2.8 kg) were randomly assigned to either the self-injection IGF-I (15 microg/kg twice daily) or placebo group and were studied at baseline, at 6 months, and at 1 yr of treatment. There were no significant differences between the IGF-I and placebo groups in any of the measured variables at baseline. Fasting blood IGF-I levels were significantly elevated above baseline values (65.6 +/- 11.9 ng/mL) at 6 months (330.0 +/- 52.8) and 12 months (297.7 +/- 40.8) in the IGF-I treated group but did not change in the placebo subjects. Circulating levels of IGF-binding protein-1 and -3 were unaffected by the IGF-I treatment. Bone mineral density of the forearm, lumbar spine, hip, and whole body [as measured by dual-energy x-ray absorptiometry (DXA)] did not change in either group. Similarly, there was no difference in DXA-measured lean mass, fat mass, or percent body fat throughout the treatment intervention. Muscle strength values (grip, bench press, leg press), blood lipid parameters (cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides), and measures of postmeal glucose disposal were not altered by IGF-I treatment, although postmeal insulin levels were lower in the IGF-I subjects at 12 months. IGF-I did not affect bone turnover markers (osteocalcin and type I collagen N-teleopeptide), but subjects who were taking estrogen had significantly lower turnover markers than subjects who were not on estrogen at baseline, 6 months, and 12 months. Finally, the psychological measures of mood and memory were also not altered by the intervention. Despite the initial intent to recruit additional subjects, the study was discontinued after 16 subjects completed the protocol, because the preliminary analyses above indicated that no changes were occurring in any outcome variables, regardless of treatment regimen. Therefore, we conclude that 1 yr of IGF-I treatment, at a dose sufficient to elevate circulating IGF-I to young normal values, is not an effective means to alter body composition or blood parameters nor improve bone density, strength, mood, or memory in older women.

Effects of diet and exercise on energy expenditure in postmenopausal women.

The purpose of this study was to determine the effect of a 24-wk diet + exercise (DE) or diet-only program on basal metabolic rate (BMR), bone mineral density (BMD), energy expended during daily activities, muscle strength, and maximal oxygen consumption (VO2max) in 40 postmenopausal women. Daily energy need was determined by measuring BMR and assessing physical activity with 8-d self-reported activity records. The DE group consumed 2092 kJ/d less than the daily energy need and walked and performed strength-training exercises during which they expended an additional 837 kJ/d. The two diet-only groups consumed either 2092 kJ/d (D-2092) or 2929 kJ/d (D-2929) less than the daily energy need. BMD, BMR, muscle strength, VO2max, and energy expended during lying, sitting, standing, and walking were measured at baseline and after 12 and 24 wk of treatment. A significant decrease in BMR and energy expended during sitting and walking occurred in all groups, with no significant differences observed among groups. Although the declines in BMR were significant, they were small and may not have been physiologically relevant. No changes in BMD or VO2max occurred, whereas strength increased significantly in the DE group. The results showed that postmenopausal women significantly improved their body composition over a period of 6 mo without experiencing a large decline in BMR, BMD, or select components of energy expenditure.

Effects of diet and exercise on common cardiovascular disease risk factors in moderately obese older women.

Diet and exercise studies of premenopausal women have shown reductions in obesity and other cardiovascular disease (CVD) risk factors. Forty-one healthy, moderately obese (120-140% of ideal body weight, LBW), postmenopausal women (65.6 +/- 3.3 y) participating in 24-wk diet or diet + exercise programs were studied to determine whether similar CVD risk reduction would occur. Daily energy need (DEN) was estimated from basal energy expenditure and self-reported activity. The diet + exercise group (n = 16) reduced their daily energy intake (DEI) by 2092 kJ from their DEN and expended 837 kJ/d in walking and resistance exercise. The two diet-only groups (n = 13 and n = 12) reduced their DEI by 2092 and 2929 kJ from their DEN, respectively. Body weight, waist-to-hip and subscapula-to-triceps ratios, blood lipids (total, low-density-lipoprotein, and high-density-lipoprotein cholesterol, and triacylglycerols), glucose, and insulin concentrations were measured at baseline and after 12 and 24 wk of diet and diet + exercise. Data were analyzed by using analysis of variance with repeated measures (P < or = 0.05) and Tukey's post hoc test. Loss of body weight was significant for all groups between baseline and 12 and 24 wk (baseline: 79.3 +/- 7.6 kg; 12 wk; 75.1 +/- 7.7 kg; 24 wk; 72.8 +/- 8.0 kg) but did not differ among groups. No significant time or treatment effects were observed between baseline and 24 wk for changes in mean blood lipid, glucose, and fasting insulin concentrations or measures of body fat distribution. Although 24 wk of diet or diet+exercise significantly reduced body weight in this group, this loss in body weight was not accompanied by a reduction of other commonly accepted CVD risks.

Efficient scheduling of cystoscopies in monitoring for recurrent bladder cancer.

Proper timing for repeated evaluations is difficult to assess. The authors analyzed scheduling of cystoscopy to monitor patients for detection of recurrent bladder cancer assuming that 1) minimizing tumor detection delay helps prevent cancer morbidities; 2) only limited numbers of cystoscopies are available; 3) prediction of recurrence or progression to invasive cancer is uncertain; 4) future tumors recur according to a Poisson process. Assumptions 3 and 4 permit estimation of each patient's recurrence rate. Thus, patients may be compared according to their relative risks of future tumors. With these assumptions, nonlinear optimization theory was used to calculate monitoring schedules for a model practice. Given 5.4 available visits per week per 100 patients, cystoscopy was recommended in 9-11 weeks for high-risk patients and in 30-40 weeks for low-risk patients, depending on stages, grades, and numbers of previous tumors. In contrast, standard cystoscopy was recommended in 13, 26, or 52 weeks, depending only on time elapsed since last recurrence. The calculated schedule implied an average detection delay for potentially invasive tumors of eight weeks, while standard practice led to detection delays of 11 weeks (38% worse). These results suggest that inclusion of each patient's tumor history in an optimization approach may improve follow-up care for patients who have superficial bladder cancers. This approach is being evaluated in a larger clinical setting.