A randomised controlled trial of interventions for taxane-induced nail toxicity in women with early breast cancer.

Onycholysis and paronychia has been associated with chemotherapy treatment for women with breast cancer. Our primary aim was to investigate the effectiveness of different topical interventions to ameliorate nail toxicity. Secondary aims were to explore the full range and severity of possible nail changes associated with taxane-based chemotherapy and the specific impact this had on quality of life, using two novel measures. This was an exploratory randomised controlled trial of three topical interventions (standard care, nail polish or specialist nail drops) for the prevention or reduction of nail changes induced by taxane-based chemotherapy. Outcomes included nail toxicity assessed at three time points (baseline, 3 weeks and 3 months post completion of chemotherapy) using two novel clinical tools (NToX-G12, NToX-QoL) and the Common Terminology Criteria for Adverse Events (CTCAE v3) and EQ-5D-5L. A total of 105 women were recruited (35 in each arm) and monitored up to three months post completion of chemotherapy. Almost 20% of patients were over the age of 60 years. There were 26 withdrawals, the majority from the nail polish arm. Residual Maximum Likelihood REML analysis indicated a significant arm, time and interaction effect for each intervention (p < 0.001). Less nail toxicity was observed in patients receiving specialist nail drops or standard care arms in comparison to those using nail polish. This study provides evidence to support clinicians' suggestions on nail care recommendations based on the patients' needs and preferences. Future investigations into comparing or combining cryotherapy and topical solutions that can support patient's decisions are warranted.

Pediatric use of insulin pump technology: a retrospective study of adverse events in children ages 1-12 years.

BACKGROUND: Growing technological improvements in insulin pump design have increased the use of these devices in young children. To better understand the types of infusion pump-related problems and associated adverse events in this age group, we performed a comprehensive evaluation of pump-related adverse event reports received by the U.S. Food and Drug Administration (FDA) for children ages 1-12 years. METHODS: A query was conducted of FDA's Manufacturer and User Facility Device Experience database from January 1, 1996, through December 31, 2009, in children ages 1-12 years involving insulin pumps. Report narratives were individually reviewed for age, gender, and seriousness of outcomes. Device or patient problems and potential contributory factors were assessed. RESULTS: Over the past 14 years, 1774 (7%) of all insulin pump adverse event reports were identified in children ages 1-12. Of these reports, 777 (43%) resulted in hospitalization. In hospitalized cases (n = 614), diabetic ketoacidosis and/or hyperglycemia were the predominant patient problems, and in other cases (n = 98), hypoglycemia was evident. There were 106 emergency room visits, 19 cases requiring paramedic attention, and five deaths. The majority of reports indicated that the devices were not returned to the manufacturer, and root causes were not always confirmed. CONCLUSIONS: Younger children with diabetes deserve careful consideration of the risk and benefit of insulin pump technology. Studies are needed to better understand pediatric safety issues and to identify the root cause of adverse events. Problems related to patient education, device misuse, and malfunctions were found, highlighting the need to strengthen user training for children and their caregivers.

Provision of information about malignant spinal cord compression: perceptions of patients and staff.

BACKGROUND: Various guidelines have highlighted the importance of patients being given information on malignant spinal cord compression (MSCC), both when diagnosed with the condition and as a tool to aid early detection. AIM: To determine patient and staff views on the provision of MSCC information to patients with a diagnosis of or considered to be at high risk of developing MSCC. METHODS: Patients with MSCC admitted to a large regional cancer centre in Scotland over a 6-month period were interviewed. Staff were also surveyed using similar questions. RESULTS: Fifty-six patients and fifty staff were recruited. Only 4% of staff reported giving any written information about MSCC to patients with a confirmed diagnosis, although 20% of patients said they received it and 77% wanted it. A total of 54% of staff reported gaving prophylactic information about MSCC to patients, although the majority of the patients (86%) said they would have wanted this information. Patients generally did not access additional information about MSCC and were dependent on the limited amount provided by the health-care team. CONCLUSION: Health professionals need to ensure that patients get the information they want, which will allow them to recognize MSCC symptoms early for improved treatment outcomes or to better adapt to a diagnosis.

An event-related potential study of response inhibition in ADHD with and without prenatal alcohol exposure.

BACKGROUND: The attention and cognitive problems seen in individuals with a history of prenatal alcohol exposure often resemble those associated with attention deficit hyperactivity disorder (ADHD), but few studies have directly assessed the unique influence of each on neurobehavioral outcomes. METHODS: We recorded event-related potentials (ERPs) during a Go/No-go response inhibition task in young adults with prospectively obtained histories of prenatal alcohol exposure and childhood ADHD. RESULTS: Regardless of prenatal alcohol exposure, participants with childhood ADHD were less accurate at inhibiting responses. However, only the ADHD group without prenatal alcohol exposure showed a markedly diminished P3 difference between No-go and Go, which may reflect a more effortful strategy related to inhibitory control at the neural processing level. CONCLUSION: This finding supports a growing body of evidence suggesting that the manifestation of idiopathic ADHD symptoms may stem from a neurophysiologic process that is different from the ADHD symptomatology associated with prenatal alcohol exposure. Individuals who have been prenatally exposed to alcohol and present with ADHD symptomatology may represent a unique endophenotype of the disorder, which may require different treatment approaches from those found to be effective with idiopathic ADHD.

Device safety and effectiveness in the pediatric population: a US FDA perspective.

The US FDA recognizes that there are many challenges to ensuring that medical devices are used responsibly and safely in the pediatric population. Education plays a key role, and manufacturers and healthcare providers must be informed of medical device issues unique to the pediatric population. Healthcare workers and device manufacturers must recognize that adverse events may differ between the adult and pediatric population and among pediatric subpopulations. Risk mitigation may also differ, and heightened awareness will reduce the potential for adverse events and promote the safe use of medical devices in children.

Adolescent use of insulin and patient-controlled analgesia pump technology: a 10-year Food and Drug Administration retrospective study of adverse events.

OBJECTIVES: From January 1, 2005, through December 31, 2005, the Food and Drug Administration received 5 adolescent death reports associated with the use of insulin pumps, raising concerns about use of this device in this age group. To understand better the types of infusion pump-related problems in adolescents, we performed a comprehensive evaluation of insulin and patient-controlled analgesic pump-related adverse events reported for adolescents that were received by the Food and Drug Administration from 1996 to 2005. METHODS: A search for medical device adverse event reports from January 1, 1996 through December 31, 2005, involving insulin pumps or patient-controlled analgesic pumps used by patients who were aged 12 to 21 years was conducted in the Food and Drug Administration's Manufacturer and User Facility Device Experience Database. Reports were reviewed for demographic characteristics, type of adverse event, and patient morbidity, and potential contributory factors were classified from narratives in the reports. RESULTS: A total of 1674 reports were identified: 1594 for insulin pumps and 53 for patient-controlled analgesic pumps. In reports of insulin pump events, there were 13 reported deaths, 2 reports that indicated possible suicide attempts, and several additional reports indicating severe hypoglycemic or hyperglycemic events that seemed to be device-related. A total of 102 (6.4%) insulin-pump reports highlighted factors that may have contributed to the adverse event, including problems associated with compliance, education, sports-related activities, and dropping or damaging the pump. Eighty-two percent of cases involving the insulin pump resulted in hospitalization. Half of the reports involving patient-controlled analgesic pumps indicated that the patient received an excess of medication; tampering and noncompliance were evident in some cases. CONCLUSIONS: Adolescents are a special population who deserve careful consideration of risk and benefit for use of device technology. Studies need to further identify safety problems in this age group.

A computerised guidance tree (decision aid) for hypertension, based on decision analysis: development and preliminary evaluation.

This paper discusses the piloting of a computerised decision aid that provides individualised information about hypertension to patients. The program is based on decision analysis, using decision trees as a way of structuring information. It incorporates the Framingham risk equation to assess a users' risk of coronary artery disease, together with a detailed assessment of the patient's current lifestyle and their willingness to change behaviour. Users of the program can decide how much or how little information they access. The program assesses individual's preferences for different treatment outcomes, before providing them with guidance on what might be the best treatment option for them. The program was evaluated by 10 patients with a diagnosis of mild to moderate hypertension and 8 health care professionals. Overall, both health care professionals and patients assessed the program positively. The use of a decision aid based on decision analysis may be a useful way of providing information to patients in order to promote shared decision making.

The development and preliminary evaluation of a decision aid based on decision analysis for two treatment conditions: benign prostatic hyperplasia and hypertension.

This paper discusses the development and evaluation of a computerised decision aid that provides individualised information about Benign Prostatic Hyperplasia (BPH) and Hypertension to patients. The program is based on decision analysis, using decision trees as a way of providing users with information regarding the probability of different outcomes occurring, obtaining an individual evaluation of the different outcomes, before providing guidance on what might be the 'best' option for that patient. It is intended that the program can be used as the basis for helping patients to become more involved in decisions about their medical treatment. Eight health care professionals and 19 patients (9 with BPH and 10 with Hypertension) evaluated the program. Overall it was assessed positively by both health care professionals and patients. However, before it can be integrated into health care practice, the program is to be evaluated further in a randomised trial.