Dialysis residential care : a future dialysis service model

People with chronic kidney disease are ageing and have increasing co-morbidities. The current delivery of renal replacement therapy, dialysis and transplantation, needs to adjust to changing patient needs. This paper proposes a potential future service delivery model featuring a dialysis residential care facility and a care coordination focus. The residential care facility would be composed of four levels of care; high, hostel, independent and outpatient. The paper argues that this model may result in decreased morbidity, improved patient quality of life and may prove cost effective. Patients' nutritional status, medication adherence and transport efficiency may be improved. We propose this model to stimulate further debate in order to meet the needs of current and future chronic kidney disease patients.

The Australian and New Zealand dialysis workforce study in the international context

Background: Given increasing demand for renal replacement therapy, this study sought to identify of key workforce issues facing dialysis units, based on a “snapshot” of the current workforce.

Methods: A web-based survey of all dialysis unit managers in Australia and New Zealand, in October 2008, about their workforce.

Results: A significant minority of dialysis staff in most regions were not registered nurses. Many renal registered nurses worked part time. Staff/patient ratios in dialysis units varied significantly by region, reflecting the relative prevalence of home therapies. Most dialysis units were generally adequately staffed. The proportion of registered nurses with specific renal qualifications varied significantly by region.

Conclusion: The changing character of the workforce in the dialysis unit in the future will require clarification of the relationships between different categories of dialysis staff. Specialty education for nurses needs to be oriented to equipping staff to be effective in their changing work environment.

The Renal Treatment Satisfaction Questionnaire (RTSQ): a measure of satisfaction with treatment for chronic kidney failure.

BACKGROUND: Quality and effectiveness of care can be enhanced through the use of condition-specific measures of satisfaction with treatment. The aim of the present study was to design and develop a measure of satisfaction with treatment for patients with chronic kidney failure (CKF) for use in routine clinical care and clinical trials. The Renal Treatment Satisfaction Questionnaire (RTSQ) was designed to be suitable for people using any of the various treatment modalities for CKF. Items measure satisfaction with aspects of treatment, including convenience, flexibility, freedom, and satisfaction to continue with present form of treatment.

METHODS: A 12-item RTSQ was investigated at a UK hospital-based renal unit, using data from 140 outpatients undergoing renal replacement therapy (hemodialysis, n = 35; continuous ambulatory peritoneal dialysis, n = 57; transplantation, n = 46).

RESULTS: An 11-item scale was developed from the original 12-item version, with a single factor accounting for 59% of the variance and item loadings greater than 0.58. Scale reliability was excellent (alpha = 0.93) in the full sample and proved robust to analysis in separate treatment subgroups. As expected, RTSQ scores differed significantly ( P < 0.0001) between the transplantation and other treatment groups. Those who had received a transplant expressed greater overall satisfaction, with specific advantages of transplantation shown by all individual items, including convenience, time, lifestyle, freedom, and satisfaction to continue current treatment.

CONCLUSION: The RTSQ provides a brief reliable measure of satisfaction with treatment for patients with CKF that is suitable for use in routine clinical care and clinical trials.

Time series analysis of the impact of tobacco control policies on smoking prevalence among Australian adults, 2001–2011

Objective: To determine the impact of tobacco control policies and mass media campaigns on smoking prevalence in Australian adults.
Methods: Data for calculating the average monthly prevalence of smoking between January 2001 and June 2011 were obtained via structured interviews of randomly sampled adults aged 18 years or older from Australia’s five largest capital cities (monthly mean number of adults interviewed: 2375). The influence on smoking prevalence was estimated for increased tobacco taxes; strengthened smoke-free laws; increased monthly population exposure to televised tobacco control mass media campaigns and pharmaceutical company advertising for nicotine replacement therapy (NRT), using gross ratings points; monthly sales of NRT, bupropion and varenicline; and introduction of graphic health warnings on cigarette packs. Autoregressive integrated moving average (ARIMA) models were used to examine the influence of these interventions on smoking prevalence.
Findings: The mean smoking prevalence for the study period was 19.9% (standard deviation: 2.0%), with a drop from 23.6% (in January 2001) to 17.3% (in June 2011). The best-fitting model showed that stronger smoke-free laws, tobacco price increases and greater exposure to mass media campaigns independently explained 76% of the decrease in smoking prevalence from February 2002 to June 2011.
Conclusion: Increased tobacco taxation, more comprehensive smoke-free laws and increased investment in mass media campaigns played a substantial role in reducing smoking prevalence among Australian adults between 2001 and 2011.

Design and conduct of a pragmatic randomized controlled trial to enhance smoking-cessation outcomes with exercise: The Fit2Quit study

Background: Most smokers want to stop smoking and many try to quit. However abstinence rates are low and most smokers do not manage to abstain for even a week. Relapse to smoking can be related to the occurrence of tobacco withdrawal symptoms (e.g., sleep disturbance, irritability, and craving) and weight gain. If regular exercise mitigates these effects it could have potential as an aid to smoking cessation. The aim of the Fit2Quit study is to determine the effects of a home and community-based exercise intervention on smoking abstinence at six months when used as an adjunct to usual care (telephone smoking-cessation counseling and nicotine replacement therapy; NRT). Methods/design: A prospective parallel two-arm randomized controlled trial. Participants (n = 1400, 700 per arm) will be randomized to a structured home and community-based exercise program plus usual care (behavioral counseling and NRT) or to usual-care alone. It is targeted that at least 25% of the sample will be of Mori ethnicity (New Zealand indigenous). Outcomes to be measured using intention-to-treat analysis include: seven-day point prevalence of smoking abstinence verified by salivary cotinine (primary outcome); 6 months continuous abstinence; body mass index (BMI); cardio-respiratory fitness; physical activity levels; and cost effectiveness. Discussion: The Fit2Quit study is an example of a large, pragmatic randomized controlled trial in a community setting. Specific components of the exercise intervention are outlined in detail. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12609000637246.

The getting physical on cigarettes trial: rationale and methods

Smoking cessation success rates are generally dismal amongst self-quitters, with a discrepancy apparent among sexes with women having lower cessation rates than men (Osler, Prescott, Godtfredsen, Hein, & Schnohr, 1999; Royce, Corbett, Sorensen, & Ockene, 1997; Wetter et al., 1999). The Getting Physical on Cigarettes project aims to be the first clinical trial to appropriately evaluate the effectiveness of home-based lifestyle exercise maintenance program in assisting women to prevent smoking relapse and maintain exercise and weight following the termination of a structured and supervised exercise and nicotine replacement therapy (NRT) smoking cessation intervention. This paper outlines the rationale and methods of the trial - a supervised exercise and NRT program lasting 14 weeks, which is followed by a home-based exercise maintenance program. Sedentary female smokers will be randomized into one of four research arms: Exercise Maintenance; Exercise Maintenance + Relapse Prevention Booklets; Relapse Prevention Booklets + Contact; Contact Control. The Exercise Maintenance groups will be counseled on maintaining exercise in their home environment, while the other groups will be counseled on health issues not involving exercise or smoking. The "Forever Free" booklet series (Brandon, Collins, Juliano, & Lazev, 2000) will be distributed to participants in the Relapse Prevention groups. The primary outcome measure is continuous smoking abstinence. Secondary outcomes are exercise behaviour, and selected physiological and psychological variables. Results will assist researchers and health professionals develop and implement similar treatment interventions that are grounded in behaviour change theory.

Exercise to enhance smoking cessation: the getting physical on cigarette randomized control trial

BACKGROUND: Exercise has been proposed as a useful smoking cessation aid. PURPOSE: The purpose of the present study is to determine the effect of an exercise-aided smoking cessation intervention program, with built-in maintenance components, on post-intervention 14-, 26- and 56-week cessation rates. METHOD: Female cigarette smokers (n = 413) participating in a supervised exercise and nicotine replacement therapy (NRT) smoking cessation program were randomized to one of four conditions: exercise + smoking cessation maintenance, exercise maintenance + contact control, smoking cessation maintenance + contact control or contact control. The primary outcome was continuous smoking abstinence. RESULTS: Abstinence differences were found between the exercise and equal contact non-exercise maintenance groups at weeks 14 (57 vs 43 %), 26 (27 vs 21 %) and 56 (26 vs 23.5 %), respectively. Only the week 14 difference approached significance, p = 0.08. CONCLUSIONS: An exercise-aided NRT smoking cessation program with built-in maintenance components enhances post-intervention cessation rates at week 14 but not at weeks 26 and 56.

Exercise counseling to enhance smoking cessation outcomes: the Fit2Quit randomized controlled trial

BACKGROUND: Regular exercise has been proposed as a potential smoking cessation aid.

PURPOSE: This study aimed to determine the effects of an exercise counseling program on cigarette smoking abstinence at 24 weeks.

METHODS: A parallel, two-arm, randomized controlled trial was conducted. Adult cigarette smokers (n = 906) who were insufficiently active and interested in quitting were randomized to receive the Fit2Quit intervention (10 exercise telephone counseling sessions over 6 months) plus usual care (behavioral counseling and nicotine replacement therapy) or usual care alone.

RESULTS: There were no significant group differences in 7-day point-prevalence and continuous abstinence at 6 months. The more intervention calls successfully delivered, the lower the probability of smoking (OR, 0.88; 95 % CI 0.81-0.97, p = 0.01) in the intervention group. A significant difference was observed for leisure time physical activity (difference = 219.11 MET-minutes/week; 95 % CI 52.65-385.58; p = 0.01).

CONCLUSIONS: Telephone-delivered exercise counseling may not be sufficient to improve smoking abstinence rates over and above existing smoking cessation services.

Health outcomes associated with hormone therapy in Australian women

The risks and benefits of hormone therapy (HT) in the treatment of postmenopausal women remain controversial. In this population-based, observational study, we documented health outcomes among postmenopausal Australian women using HT. Women aged 60-80 years were recruited into the Geelong Osteoporosis Study 1994-7 and followed over a median period of 6.6 years. Mortality, and the development of vascular events, breast and colorectal cancers were documented for 67 HT-users and 521 non-users. Median duration of HT-use was 5.0 years (IQR 3.0-10.0). There was no excess in all-cause mortality associated with HT-use. Based on 92 deaths (six HT-users, 86 non-users), the adjusted odds ratio (OR) for all-cause mortality was 0.79 (95%CI 0.32-1.97). With 99 reports of vascular events (13 HTusers, 86 non-users), the adjusted OR for vascular events was 1.30 (95%CI 0.66-2.57). There were insufficient numbers of breast or colorectal cancer cases (21 breast cancer cases, all non-HT users; and 7 colorectal cancer cases, one HT-user and six non-users) to adequately calculate the risk associated with exposure to HT. Although the sample size was small, these results do not support an association between HT and mortality, despite a possible link between HT and increased risk of developing vascular disease.

Hormone therapy and risk of non-vertebral fracture : Geelong Osteoporosis Study

In this population-based study, we evaluated the association between exposure to hormone therapy (HT), bone mineral density (BMD) and the prevalence of non-vertebral fractures. The study was set in a region located in southeastern Australia where complete fracture ascertainment was determined from radiological reports. Current HT use for at least 6 months was ascertained in women with non-vertebral fractures [median age 70.9 years; inter-quartile range (IQR) 66.5–75.9 years] and randomly selected controls (median age 70.8 years; IQR 65.2–75.0 years). Current HT use was documented in 20 of 262 cases and 49 of 364 controls. The odds ratio (OR) for non-vertebral fracture associated with HT use was 0.53 (95% CI 0.31–0.92). HT use was associated with 2.6–7.5% higher BMD at axial and appendicular sites. HT use is associated with a halving of risk for non-vertebral fractures and higher BMD.

Sexual desire in women presenting for anti-androgen therapy

Women presenting with hirsuties/polycystic ovary syndrome have increased production of androgens. Clinical lore suggests that these women may have increased sexual desire. Treatment of hirsuties commonly involves antiandrogen therapy, a form of therapy with a potential for reducing sexual desire. The present study investigated sexual desire in 29 hirsute women aged 19 to 43 years presenting for therapy. We conducted a questionnaire appraisal of the women's sexual desire, body and self-esteem, and affect at baseline, 3 months, and 12 months and compared the data with a control group of 30 nonhirsute women of similar mean age. Those in the treatment group also had their Ferriman and Gallwey scores and body mass indices calculated at baseline and end of study for those in the treatment group. We determined hormone levels for those in the treatment group with baseline blood tests. Our hypotheses were that the hirsute women would experience different levels of sexual desire than the control group prior to therapy and that therapy would have a demonstrable effect on the self-reported sexual desire of these women. The study demonstrated that women with hirsuties had mean levels of sexual desire and body esteem that were significantly lower than the control group women. During the year-long course of therapy, the sexual desire levels of the hirsute women decreased progressively, while their self-esteem increased. The women's Ferriman and Gallwey scores fell, indicating diminishing hirsutism. These findings provide empirical data upon which clinicians can base advice to patients seeking therapy.

Growth and development in a child with resistance to thyroid hormone and ectopic thyroid gland

Resistance to thyroid hormone is an uncommon problem, which has rarely been associated with thyroid dysgenesis. We report a case with both thyroid gland ectopy and resistance to thyroid hormone and, thus, a reduced capacity to produce and respond to thyroid hormone. The patient presented at 2 years of age with developmental delay, dysmorphic features, and elevation in both thyroxine and thyrotropin. We document her response to therapy with thyroxine, with particular regard to her growth and development. Persistent elevation of thyrotropin is commonly recognized during treatment of congenital hypothyroidism. Resistance to thyroid hormone may be an important additional diagnosis to consider in cases where thyrotropin remains persistently elevated.

Effect of adjunctive raloxifene therapy on severity of refractory schizophrenia in women: a randomized clinical trial

IMPORTANCE: A substantial proportion of women with schizophrenia experience debilitating treatment-refractory symptoms. The efficacy of estrogen in modulating brain function in schizophrenia has to be balanced against excess exposure of peripheral tissue. Raloxifene hydrochloride is a selective estrogen receptor modulator (mixed estrogen agonist/antagonist) with potential psychoprotective effects and fewer estrogenic adverse effects. OBJECTIVE: To determine whether adjunctive raloxifene therapy reduces illness severity in women with refractory schizophrenia. DESIGN, SETTING, AND PARTICIPANTS: This 12-week, double-blind, placebo-controlled, randomized clinical trial with fortnightly assessments was performed at an urban tertiary referral center and a regional center from January 1, 2006, to December 31, 2014. Participants included 56 women with schizophrenia or schizoaffective disorder and marked symptom severity despite substantial and stable antipsychotic doses. Data were analyzed using intention to treat as the basis. INTERVENTIONS: Adjunctive raloxifene hydrochloride, 120 mg/d, or placebo for 12 weeks. MAIN OUTCOMES AND MEASURES: The primary outcome was the change in the Positive and Negative Syndrome Scale (PANSS) total score. Clinical response (defined as a ≥20% decrease in PANSS total score from baseline) and change in PANSS subscale scores, mood, cognition, reproductive hormone levels, and adverse events were also assessed. RESULTS: Of the 56 participants (mean [SD] age, 53 [7.7] years; age range, 40-70 years; mean [SD] duration of psychotic illness, 24 [11] years), 26 were randomized to raloxifene and 30 were randomized to placebo. Raloxifene produced a greater reduction in the PANSS total score relative to placebo (β = -6.37; 95% CI, -11.64 to -1.10; P = .02) and resulted in an increased probability of a clinical response (hazard ratio, 5.79; 95% CI, 1.46 to 22.97; P = .01). A significant reduction was found in the PANSS general symptom scores for the raloxifene compared with the placebo (β = -3.72; 95% CI, -6.83 to -0.61; P = .02) groups. For patients who completed the full 12-week trial, there was not a statistically significant treatment effect on PANSS positive symptom scores (β for change in raloxifene vs placebo, -1.92; 95% CI, -3.83 to 0.00; P = .05). Change in mood, cognition, and reproductive hormone levels and the rate of adverse events did not differ between groups. CONCLUSIONS AND RELEVANCE: Raloxifene hydrochloride, 120 mg/d, reduces illness severity and increases the probability of a clinical response in women with refractory schizophrenia. This large trial of raloxifene in this patient population offers a promising, well-tolerated agent that has potential application in clinical practice. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00361543.