Patient acceptability of three different central venous access devices for the delivery of systemic anticancer therapy: a qualitative study.

OBJECTIVE: Three types of central venous access devices (CVADs) are routinely used in the delivery of intravenous systemic anticancer therapy (SACT): peripherally inserted central catheters (PICCs), subcutaneously tunnelled central catheters (Hickman-type devices) and totally implantable chest wall ports (Ports). This qualitative study, nested within a multicentre, randomised controlled trial, sought to explore patient acceptability and experiences of the three devices. DESIGN: Eight focus groups were audio-recorded, transcribed and thematically analysed. SETTING: Six outpatient cancer treatment centres in the UK. PARTICIPANTS: Forty-two patients (20 female, mean age 61.7 years) who had taken part or were taking part in the broader trial. INTERVENTION: As part of the larger, randomised controlled trial, participants had been randomly assigned one of three CVADs for the administration of SACT. RESULTS: Attitudes towards all three devices were positive, with patients viewing their CVAD as part of their treatment and recovery. Participants with PICCs and Hickmans tended to compare their device favourably with peripheral cannulation. By comparison, participants with Ports consistently compared their device with PICCs and Hickmans, emphasising the perceived superiority of Ports. Ports were perceived to offer unique psychological benefits, including a greater sense of freedom and less intrusion in the context of personal relationships. CONCLUSIONS: Patient experiences and preferences have not been systematically used to inform policy and practice regarding CVAD availability and selection. Our research identified patterns of patient device preferences that favoured Ports, although this was not universal. Results of this study could improve support for patients and offer greater scope for incorporating patient perspectives into decision-making processes. TRIAL REGISTRATION NUMBER: ISRCTN44504648.

Coping strategies in people with type 1 diabetes on insulin pump treatment.

BACKGROUND: In stressed people with diabetes (PWD) glycemia varies idiosyncratically. Coping is a relatively stable personality trait that assesses how individual deals with stress. Insulin pumps are considered the best insulin delivery system but require more attention from PWD, virtually increasing stress levels. Aim of our study was to evaluate the coping strategies adopted by a pool of participants with type 1 diabetes mellitus (T1DM) on continuous subcutaneous insulin infusion (CSII) therapy. METHODS: We collected data from 158 people with T1DM on CSII. COPE-NVI Test was administered and we also collected: hemoglobin A1c (HbA1c), 30 days of self-monitoring of blood glucose (SMBG) and continuous glucose monitoring (CGM) records (the most recent). From SMBG and CGM records we computed Kovatchev indexes. We investigated bivariate correlations between HbA1c, indexes and the results of the COPE-NVI Test; the analysis was performed on the total sample and on two sub-groups: men and women. The participants were then divided into clusters and non-parametric tests were performed. RESULTS: Regarding bivariate correlation, at a level of significance of 95%, several statistically significant correlations were found in the total sample and in both men and women sub-groups. Regarding non-parametric tests, we observed statistically significant results in clusters of the total sample and clusters of the sub-group formed by men, divided according to Low Blood Glucose Index (LBGI) risk, showing a different use of certain coping strategies. CONCLUSIONS: Assessing coping strategies preferably used by PWD is useful to select PWD in need of counseling and empowerment-oriented training in order to improve glycemic outcomes and decrease severe hypo/hyperglycemic events.

Effect of chronic delivery of the Toll-like receptor 4 antagonist (+)-naltrexone on incubation of heroin craving.

BACKGROUND: Recent evidence implicates toll-like receptor 4 (TLR4) in opioid analgesia, tolerance, conditioned place preference, and self-administration. Here, we determined the effect of the TLR4 antagonist (+)-naltrexone (a µ-opioid receptor inactive isomer) on the time-dependent increases in cue-induced heroin seeking after withdrawal (incubation of heroin craving). METHODS: In an initial experiment, we trained rats for 9 hours per day to self-administer heroin (.1 mg/kg/infusion) for 9 days; lever presses were paired with a 5-second tone-light cue. We then assessed cue-induced heroin seeking in 30-minute extinction sessions on withdrawal day 1; immediately after testing, we surgically implanted rats with Alzet minipumps delivering (+)-naltrexone (0, 7.5, 15, 30 mg/kg/day, subcutaneous) for 14 days. We then tested the rats for incubated cue-induced heroin seeking in 3-hour extinction tests on withdrawal day 13. RESULTS: We found that chronic delivery of (+)-naltrexone via minipumps during the withdrawal phase decreased incubated cue-induced heroin seeking. In follow-up experiments, we found that acute injections of (+)-naltrexone immediately before withdrawal day 13 extinction tests had no effect on incubated cue-induced heroin seeking. Furthermore, chronic delivery of (+)-naltrexone (15 or 30 mg/kg/day) or acute systemic injections (15 or 30 mg/kg) had no effect on ongoing extended access heroin self-administration. Finally, in rats trained to self-administer methamphetamine (.1 mg/kg/infusion, 9 hours/day, 9 days), chronic delivery of (+)-naltrexone (30 mg/kg/day) during the withdrawal phase had no effect on incubated cue-induced methamphetamine seeking. CONCLUSIONS: The present results suggest a critical role of TLR4 in the development of incubation of heroin, but not methamphetamine, craving.

Effects of chronic nicotine, nicotine withdrawal and subsequent nicotine challenges on behavioural inhibition in rats.

RATIONALE: Drug addiction is a chronically relapsing disorder characterised by compulsive drug use and loss of control over drug intake. Although several theories propose impulsivity as a key component of addiction, the precise nature of this relationship remains unclear. OBJECTIVES: This study aims to investigate the short- and longer-term effects of chronic nicotine administration on behavioural inhibition. METHODS: Rats were trained on a symmetrically reinforced go/no-go task, following which they were subcutaneously prepared with osmotic minipumps delivering either nicotine (3.16 mg kg(-1) day(-1) (freebase)) or saline for 7 days. Performance was assessed daily during chronic treatment, in early and late abstinence, and in response to acute nicotine challenges following prolonged abstinence. RESULTS: Chronic nicotine resulted in a transient reduction in inhibitory control. Spontaneous withdrawal was associated with a nicotine abstinence syndrome, the early stages of which were characterised by a significant increase in inhibitory control. This was, however, short-lived with a decrease in inhibition observed in the second week of abstinence. Whilst performance returned to baseline by the end of the third week, acute challenges (0.125, 0.25, 0.5 mg/kg, SC) revealed that nicotine exposure had sensitised animals to the disinhibitory effects of the compound. CONCLUSIONS: Drug-induced loss of inhibitory control may be critically involved both in the initial and later stages of addiction. Neuroadaptations occurring during chronic exposure to and/or withdrawal from nicotine render animals more sensitive to the disinhibitory effects of the drug. Longer-term changes in behaviour may play an important role in the increased susceptibility to relapse in those with a history of nicotine abuse.

Health-related quality of life and treatment satisfaction in the Sensor-Augmented Pump Therapy for A1C Reduction 3 (STAR 3) trial.

OBJECTIVE: This study assessed health-related quality of life (HRQOL) and treatment satisfaction in sensor-augmented pump therapy (SAPT) compared with optimal conventional therapy-multiple daily injection (MDI) therapy with self-monitoring of blood glucose (SMBG)-in adults and children with type 1 diabetes and children's caregivers. Patient acceptance of new therapies is essential to their adoption and effective use. RESEARCH DESIGN AND METHODS: STAR 3, a randomized 12-month clinical trial, compared SAPT with MDI+SMBG in 485 adult and pediatric patients. Within- and between-treatment arm changes in generic HRQOL, diabetes-specific HRQOL (fear of hypoglycemia), and treatment satisfaction were assessed (significance criterion P<0.01). RESULTS: In adults, children, and caregivers, there were no significant between-arm changes in generic HRQOL: SF-36 Physical Component Summary and Mental Component Summary scores in adults and the PedsQL Physical Health Summary and Psychosocial Health Summary scores in children or caregivers. Diabetes-specific HRQOL (Hypoglycemia Fear Survey Worry and Behavior subscale scores) improved more in SAPT than in MDI adults. Hypoglycemia Behavior scores improved more in SAPT caregivers. Key treatment satisfaction measures (Insulin Delivery System Rating Questionnaire measures of Convenience, Efficacy, and Overall Preference) improved more in SAPT adults, children, and caregivers (all P<0.001); all exceeded the criterion for minimal detectable difference. CONCLUSIONS: In the first-ever large-scale study of SAPT compared with optimal conventional therapy, SAPT had significant advantages for hypoglycemia fear in adults and caregivers and for treatment satisfaction in adults, children, and caregivers.

Role of pretrial systemic opioid requirements, intrathecal trial dose, and non-psychological factors as predictors of outcome for intrathecal pump therapy: one clinician's experience with lumbar postlaminectomy pain.

OBJECTIVE: Non-psychological parameters may predict pump success. METHODS: Review was performed on 35 implants for gender, age, pretrial/trial dose, baseline visual analog scale (VAS), and pain location. One-year outcomes were % change VAS/intrathecal dose and medication change. Spearman coefficients correlated pretrial/trial dose, age, baseline VAS, and % change in VAS/intrathecal dose. Wilcoxon Rank-Sum tests correlated gender/pain location and % change in VAS/intrathecal dose. Pretrial/trial dose, baseline VAS, and medication change was tested using Wilcoxon Rank-Sums. Chi-square was used to correlate medication change with gender/pain location. A two-sample t-test compared age and medication change. RESULTS: Positive correlation between % change VAS and trial dose was noted. Greater age correlated with lower VAS and % dose change. Marginally significant difference in % dose change by pain location was present with higher doses for leg pain. CONCLUSION: Trial dose, age, and partially pain location are good predictors of pain relief.

Factors associated with adherence to continuous subcutaneous insulin infusion in pediatric diabetes.

BACKGROUND/AIMS: Continuous subcutaneous insulin infusion (CSII) is a safe and effective alternative to insulin injections in pediatric type 1 diabetes mellitus. CSII can be associated with an increased risk of hypoglycemia and diabetic ketoacidosis (DKA) in some patients. In our Center, patients/guardians are screened for proficiency in diabetes management skills as a prerequisite to initiation of CSII. We reviewed the clinical data from our patients to assess the predictors associated with nonadherence to CSII therapy. METHODS: We retrospectively collected clinical data on all our CSII initiations between July 1999 to June 2003, including: body mass index, hemoglobin A1c (HbA1c), total daily dose, bolus to basal insulin ratio, hypoglycemic episodes (blood glucose <60 mg/dL/week), mean fasting self-monitored blood glucose (SMBG), severity of lipohypertrophy, DKA, and pubertal status. RESULTS: Forty-six patients 9.90 +/- 3.4 years old (28 girls and 18 boys) started CSII in the 4-year period. While 39 patients (85%) 9.8 +/- 3.5 years old currently remain on CSII, seven patients (15%) 11.2 +/- 0.9 years old discontinued CSII. Fifteen patients (32.6%) were prepubertal at CSII initiation, and none discontinued CSII in this cohort, whereas seven of 31 (22.6%) pubertal patients discontinued CSII. The patients who continued CSII were similar to the CSII-discontinued cohort at baseline. At 12 months, rising HbA1c was the only predictor of future nonadherence to CSII. At 24 months, the discontinuation group had higher mean fasting SMBG levels and severe lipohypertrophy (P < 0.05). None of the prepubertal patients discontinued CSII, while all seven patients (100%) in the CSII-discontinued group were pubertal (P < 0.001). CONCLUSIONS: Extensive screening by a multidisciplinary diabetes team prior to initiation of CSII regimen results in relatively lower discontinuation rates and a higher chance of maintaining optimal glycemic control (HbA1C < 8%) compared to previous studies.

[Importance of intrathecal pain therapy]. / Stellenwert der intrathekalen Schmerztherapie.

Intraspinal drug infusion using implantable pumps and catheter systems is a safe and effective therapy for selected pain patients with severe chronic pain. It improves pain relief, reduces drug-related side effects, decreases the need for oral analgesia and enhances quality of life in a segment of chronic pain patients whose pain has not been controlled with more conservative therapies. Intrathecal drug therapy has therefore established its role in the treatment of malignant pain, benign pain and severe spasticity.Careful patient selection and management as well as a multidisciplinary approach are determinants of successful treatment. Current practices for patient selection and management, screening, drug selection, dosing and implantation for intrathecal drug delivery systems are discussed.

Treatment challenges and complications with ziconotide monotherapy in established pump patients.

BACKGROUND: The U.S. Food and Drug Administration (FDA) recently approved Ziconotide intrathecal infusion for the management of severe chronic pain in patients for whom intrathecal therapy is warranted, and who are intolerant of, or refractory to, other methods of treatment, including intrathecal morphine. Ziconotide is approved as a monotherapy, but there are challenges associated with the decision to wean intrathecal opioids for Ziconotide alone. Maintaining adequate analgesia and managing opioid withdrawal symptoms may be difficult. Additionally, a variety of adverse physiological, cognitive and psychiatric events may be associated with this new drug. Patients with pretreatment psychiatric disorders may be at increased risk for treatment complications. OBJECTIVE: To present a report of a case series describing treatment challenges and complications associated with the decision to convert established pump patients from intrathecal opioid therapy to Ziconotide monotherapy. DESCRIPTION OF CASES: Three established pump patients, refractory to intrathecal opioid therapy, were converted to Ziconotide monotherapy. All of these patients experienced significant emotional distress or psychological symptoms that threatened the success of the treatment. Achieving adequate analgesia, reducing Ziconotide to mitigate adverse physiological effects, managing opioid withdrawal symptoms, and supportive psychological consultation were combined to achieve successful outcomes in two of our three patients. CONCLUSION: This report describes challenges associated with the decision to convert established pump patients from intrathecal opioid therapy to Ziconotide monotherapy. Inadequate analgesia, adverse medication effects, and opioid withdrawal symptoms can precipitate a stressful situation that may be perceived as dangerous or threatening by patients who are predisposed to anxiety. Screening patients for psychiatric disorders, anxiety-proneness and/or vulnerability to stress should be considered to reduce the risk of treatment complications. A multimodal approach is strongly advocated, including rapid responses of treating physicians and nurses along with strong psychological support.

Advancing the field of drug delivery: taking aim at cancer.

Drug delivery systems for cancer therapeutics have now been used by millions of patients and have resulted in the creation of new therapies as well as significantly improving existing ones. Here we discuss a number of the drug delivery systems that have been approved by regulatory authorities and that are currently in clinical use, such as controlled delivery of cancer therapeutics, local chemotherapy, polymer drug conjugates, liposomal systems, and transdermal drug delivery patches. The next generation of "smart" drug delivery approaches such as controlled release microchips are discussed as are some of the future challenges and directions in this field.

A self-report of quality of life of patients receiving intrathecal baclofen therapy.

The purpose of this study was to explore through a department quality improvement tool a possible relation between quality of life (QOL), complication rates, and length of intrathecal baclofen (IB) treatment as reported by patients receiving IB therapy in a community-based rehabilitation center outpatient clinic. A second objective was to examine complication rates among the clinic's patients. No conclusions could be drawn as to the relation between QOL, various reported complications, and length of treatment. A rank order frequency of areas reported by respondents to have the greatest impact on their QOL could be extrapolated from the data collected. In addition, complication rates among the patients who responded to the survey could be reported. Surveys from 49 patients about their experiences with IB therapy were analyzed. Respondents included 30 adult and 19 pediatric patients. Thirty-six patients (73%) had used the IB pump for 1 year or more. The survey included questions about QOL, complications, and length of IB treatment. Forty-three respondents (88%) stated they felt that their QOL had improved with IB therapy. Four patients (8%) responded that they were not sure that it had, and only 2 patients (4%) said that IB had not improved their QOL. The most frequently reported positive effects on QOL were reported in the following areas: spasticity control without the sedative effect of oral medication; ease of care for caregivers; easier positioning; less pain/increased comfort; and improved patient transfers. High ratings of improvement in the patients' QOL were reported despite a reported overall complication rate of 39%. The most common complications cited were infection and catheter breakage or disconnect. The overall infection rate for respondents was 10% (5 patients of the 49 surveyed reported infection). The rate of catheter breakage or disconnect was also 10%. Despite the complications reported, 46 patients stated they would recommend baclofen treatment to others. Three patients did not respond to the question. None of the patients said they would not recommend baclofen to others.

[Psychological impact of presence of an implantable catheter in patients with serious illnesses]. / Retentissement psychologique de la présence d'une chambre implantable chez un patient atteint de maladie grave.

Implantation of an infusion device propels the patient into the world of serious disease, uncertainty, and burdensome treatments. A repository for anxiety and fear, the device will remain a foreign body perceived as beneficial at some times and threatening at others, and as a source of distress. Although it provides greater comfort, self-sufficiency, and freedom from treatment-related constraints, it modifies or even disrupts the relationship with health care providers, causing the patient to feel ensnared in the meshes of submission to and dependency on disease and the medical profession. To find some measure of relief from anxiety and to cushion the blow of this new reality, the patient uses coping mechanisms that are often surprisingly complex. The physicians and other health care professionals who provide support to their patients, remaining close to their psychological reality, are faced with the difficult task of reconciling the psychological effects of perfusion device implantation with imperative therapeutic needs.

Evaluation of the psychosocial impact of the MiniMed variable-rate implantable insulin pump.

We examined the psychosocial impact of treatment with an implantable insulin pump among persons with insulin-dependent diabetes mellitus (IDDM). Of specific interest was whether use of the MiniMed implantable insulin pump (MIP) resulted in changes in functional status, performance of diabetes self-care behavior, psychologic symptoms, and perceived level of stress. From a sample of 36 patients with IDDM, 10 persons were randomly selected to receive the MIP, while the remaining 26 served as control subjects. Additionally, a nonrandom sample of three MIP recipients from an additional site were included in the MIP group. At regular assessment intervals, all participants completed self-report questionnaires regarding psychosocial functioning and monitored blood glucose levels. After 4 months of MIP use, MIP recipients did not significantly differ from control subjects on any measure of psychosocial functioning; however, MIP use did have an impact on diabetes self-care. The MIP users monitored their blood glucose levels more frequently and had lower average blood glucose levels than control subjects. Additional follow-up is needed to determine the long-term psychosocial impact of implantable insulin pump therapy.

[Intravenous administration of deferoxamine in over-night hospitalization: efficacy and good psychological tolerance in thalassemic children]. / Administration intraveineuse de desférioxamine en hospitalisation de nuit: efficacité et bonne tolérance psychologique pour les enfants thalassémiques.

Daily subcutaneous infusion of deferoxamine in thalassemia and other transfusion dependent-patients can successfully treat iron overload, but most patients, mainly young children and teenagers may not comply with this method. Experience with nightly intravenous infusion of deferoxamine (8 g) through a subcutaneous-port over 5 out of 21 days, is reported in 4 children with dramatic improvement in clinical status, ferritin levels and quality of life.

Changes in cognitive and social functioning of diabetic patients following initiation of insulin infusion therapy.

Functional health outcomes resulting from intensive insulin regimens may differ depending upon the age of the diabetic patient. This study tested the hypothesis that health functioning is poorer for younger insulin-dependent diabetic (IDDM) patients following a change to the insulin infusion pump regimen, with progressive improvements occurring in functional health status at higher age levels. Thirty IDDM patients aged 10-47 years were administered health status instruments prior to changing to the new regimen, and again six months later. The instruments assessed physical, cognitive, psychological, and social health functioning. When compared at six months to an age-matched control group on conventional insulin therapy, declines in social activities were found for younger insulin pump patients, with improvements occurring linearly as age increased. Lower performance levels were also found for the younger patients in Conceptual Quotient (CQ), an indicator of cognitive functional status, with progressive improvements with age through the early 30s. However, corresponding declines in function occurred at the oldest age levels. Adaptation to an intensive diabetes regimen appears to be more difficult at younger and older age levels.