Outcomes of Aural Rehabilitation Provided in Person or by Telehealth Among Deaf/Hard of Hearing Young Children with Cochlear Implants or Hearing Aids.

Background: Cochlear implants and hearing aids may facilitate the development of listening and spoken language (LSL) in deaf/hard of hearing young children, but they require aural rehabilitation therapy-often unavailable outside urban areas-for optimal outcomes. This trial assessed the relative effectiveness of LSL therapy delivered either in person or by interactive video. The hypothesis was that telehealth service delivery would be noninferior to in-person therapy. Methods: Most parents refused randomization of their children to telehealth or in-person conditions; therefore, randomization was impossible. In consultation with the funder (NIDCD), the study design was modified. Parents were allowed to select their preferred study condition, and the study team was blinded to group membership. Forty-two families were in the in-person group and 35 in telehealth (40 and 30, respectively, after attrition). Primary endpoints were total score, auditory comprehension, and expressive communication on the Preschool Language Scale, 5th edition. There were several secondary speech, hearing, and language outcome measures. Assessments occurred at baseline and at follow-up after 6 months of LSL therapy. Results: Propensity scores were used to create two matched groups. At baseline, groups did not differ on PLS-5 scores. Change from baseline to F/U on age-equivalents for all three scores was nearly identical for both groups, although the telehealth group was younger, on average, than the in-person group. Discussion: Telehealth was noninferior to in-person services for all primary endpoints. For secondary outcomes, neither group demonstrated a significant advantage. Magnitudes of estimated group differences were small, suggesting nonsignificant differences not predominantly because of sample size. The telehealth group showed greater improvement on 15/24 of secondary language outcome measures. The findings provide evidence that telehealth is equivalent to in-person care for providing LSL therapy to young children with cochlear implants and hearing aids.

Regional variation in mortality and subsequent hospitalization of nursing residents with heart failure.

OBJECTIVE: Do demographics, clinical characteristics, care structures, mortality, and rehospitalization differ by region among a national sample of nursing home (NH) residents with heart failure (HF)? METHODS: Retrospective observational study of NH residents with HF by ICD-9 CM codes or Minimum Data Set (MDS) diagnosis, using the Linked Nursing Home/Skilled Nursing Facility Stay File, containing MDS, hospitalization, and mortality data for all residents in a 10% random sample of NHs (n = 1840) during 2003-2004. Facility characteristics, demographics, functional characteristics, comorbidity, and outcomes were described by geographic region. Baseline characteristics and care structures for subjects who experienced a subsequent HF hospitalization or death were compared with those who did not, using unadjusted odds ratios and chi-square tests or Fisher's exact tests for categorical, and t tests or Wilcoxon Rank Sum tests for continuous variables. Predictive logistic regression models for mortality in all subjects and HF hospitalization in subjects with a single NH stay of fewer than 90 days were developed. Time to first HF hospitalization in longer-stay subjects was analyzed using Cox models. RESULTS: Mortality of NH residents with HF exceeds 45%; HF hospitalization exceeds 50% annually. Residing in a facility with 50 or fewer beds or in the rural South were both associated with lower risk of death. Older age and residing in the Midwest were associated with higher risk of HF hospitalization. CONCLUSION: Age, comorbidity, and functional impairment were not clinically different among regions of the country, but both mortality and HF hospitalization rates differed significantly by region.

Physical exercise among participants in the Dialysis Outcomes and Practice Patterns Study (DOPPS): correlates and associated outcomes.

BACKGROUND: Levels of physical exercise among haemodialysis patients are low. Increased physical activity in this population has been associated with improved health-related quality of life (HRQoL) and survival. However, results of previous studies may not be applicable to the haemodialysis population as a whole. The present study provides the first description of international patterns of exercise frequency and its association with exercise programmes and clinical outcomes among participants in the Dialysis Outcomes and Practice Patterns Study (DOPPS). METHODS: Data from a cross section of 20,920 DOPPS participants in 12 countries between 1996 and 2004 were analysed. Regular exercise was defined as exercise frequency equal to or more than once/week based on patient self-report. Linear mixed models and logistic regression assessed associations of exercise frequency with HRQoL and other psychosocial variables. Mortality risk was calculated in Cox proportional hazard models using patient-level (patient self-reported exercise frequency) and facility-level (the dialysis facility percentage of regular exercisers) predictors. RESULTS: Regular exercise frequency varied widely across countries and across dialysis facilities within a country. Overall, 47.4% of participants were categorized as regular exercisers. The odds of regular exercise was 38% higher for patients from facilities offering exercise programmes (adjusted odds ratio = 1.38 [95% confidence interval: 1.03-1.84]; P = 0.03). Regular exercisers had higher HRQoL, physical functioning and sleep quality scores; reported fewer limitations in physical activities; and were less bothered by bodily pain or lack of appetite (P

Independent and joint associations of nutritional status indicators with mortality risk among chronic hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS).

OBJECTIVE: To consider the Kidney Disease Outcomes Quality Initiative recommendation of using multiple nutritional measurements for patients on maintenance dialysis, we explored data for independent and joint associations of nutritional indicators with mortality risk among maintenance hemodialysis patients treated in 12 countries. SETTING: Dialysis units in seven European countries, the United States, Canada, Australia, New Zealand, and Japan. MAIN OUTCOME: Mortality risk. METHODS: We conducted a prospective cohort study of 40,950 patients from phases I to III of the Dialysis Outcomes and Practice Patterns Study (1996-2008). Independent and joint effects (interactions) of nutritional indicators (serum creatinine, serum albumin, normalized protein catabolic rate, body mass index [BMI]) on mortality risk were assessed by Cox regression with adjustments for demographics, years on dialysis, and comorbidities. RESULTS: Important variations in nutritional indicators were seen by country and patient characteristics. Poorer nutritional status assessed by each indicator was independently associated with higher mortality risk across regions. Significant multiplicative interactions (each p < or = 0.01) between indicators were also observed. For example, by using patients with serum creatinine 7.5-10.5 mg/dL and BMI 21-25 kg/m(2) as referent, BMI <21 kg/m(2) was associated with lower mortality risk among patients with creatinine >10.5 mg/dL (relative risk = 0.68) but with higher mortality risk among those with creatinine <7.5 mg/dL (relative risk = 1.38). The association of lower albumin concentration with higher mortality risk was stronger for patients with lower BMI or lower creatinine. CONCLUSION: The joint effects of nutritional indicators on mortality indicate the need to use multiple measurements when assessing the nutritional status of hemodialysis patients.

Consistent aspirin use associated with improved arteriovenous fistula survival among incident hemodialysis patients in the dialysis outcomes and practice patterns study.

BACKGROUND AND OBJECTIVES: The relationship between aspirin use and arteriovenous fistula (AVF) survival has been lacking. The aim of this study was to evaluate the association between AVF survival and aspirin use. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Data on 2815 incident hemodialysis patients (on dialysis

Vascular access use and outcomes: an international perspective from the Dialysis Outcomes and Practice Patterns Study.

BACKGROUND: A well-functioning vascular access (VA) is essential to efficient dialysis therapy. Guidelines have been implemented improving care, yet access use varies widely across countries and VA complications remain a problem. This study took advantage of the unique opportunity to utilize data from the Dialysis Outcomes and Practice Patterns Study (DOPPS) to examine international trends in VA use and trends in patient characteristics and practices associated with VA use from 1996 to 2007. DOPPS is a prospective, observational study of haemodialysis (HD) practices and patient outcomes at >300 HD units from 12 countries and has collected data thus far from >35,000 randomly selected patients. METHODS: VA data were collected for each patient at study entry (1996-2007). Practice pattern data from the facility medical director, nurse manager and VA surgeon were also analysed. RESULTS: Since 2005, a native arteriovenous fistula (AVF) was used by 67-91% of prevalent patients in Japan, Italy, Germany, France, Spain, the UK, Australia and New Zealand, and 50-59% in Belgium, Sweden and Canada. From 1996 to 2007, AVF use rose from 24% to 47% in the USA but declined in Italy, Germany and Spain. Moreover, graft use fell by 50% in the USA from 58% use in 1996 to 28% by 2007. Across three phases of data collection, patients consistently were less likely to use an AVF versus other VA types if female, of older age, having greater body mass index, diabetes, peripheral vascular disease or recurrent cellulitis/gangrene. In addition, countries with a greater prevalence of diabetes in HD patients had a significantly lower percentage of patients using an AVF. Despite poorer outcomes for central vein catheters, catheter use rose 1.5- to 3-fold among prevalent patients in many countries from 1996 to 2007, even among non-diabetic patients 18-70 years old. Furthermore, 58-73% of patients new to end-stage renal disease (ESRD) used a catheter for the initiation of HD in five countries despite 60-79% of patients having been seen by a nephrologist >4 months prior to ESRD. Patients were significantly (P < 0.05) less likely to start dialysis with a permanent VA if treated in a faciity that (1) had a longer time from referral to access surgery evaluation or from evaluation to access creation and (2) had longer time from access creation until first AVF cannulation. The median time from referral until access creation varied from 5-6 days in Italy, Japan and Germany to 40-43 days in the UK and Canada. Compared to patients using an AVF, patients with a catheter displayed significantly lower mean Kt/V levels. CONCLUSIONS: Most countries meet the contemporary National Kidney Foundation's Kidney Disease Outcomes Quality Initiative goal for AVF use; however, there is still a wide variation in VA preference. Delays between the creation and cannulation must be improved to enhance the chances of a future permanent VA. Native arteriovenous fistula is the VA of choice ensuring dialysis adequacy and better patient outcomes. Graft is, however, a better alternative than catheter for patients where the creation of an attempted AVF failed or could not be created for different reasons.

Enhanced training in vascular access creation predicts arteriovenous fistula placement and patency in hemodialysis patients: results from the Dialysis Outcomes and Practice Patterns Study.

OBJECTIVE: To investigate whether intensity of surgical training influences type of vascular access placed and fistula survival. SUMMARY BACKGROUND DATA: Wide variations in fistula placement and survival occur internationally. Underlying explanations are not well understood. METHODS: Prospective data from 12 countries in the Dialysis Outcomes and Practice Patterns Study were analyzed; outcomes of interest were type of vascular access in use (fistula vs. graft) in hemodialysis patients at study entry and time from placement until primary and secondary access failures, as predicted by surgical training. Logistic and Cox regression models were adjusted for patient characteristics and time on hemodialysis. RESULTS: During training, US surgeons created fewer fistulae (US mean = 16 vs. 39-426 in other countries) and noted less emphasis on vascular access placement compared with surgeons elsewhere. Significant predictors of fistula versus graft placement in hemodialysis patients included number of fistulae placed during training (adjusted odds ratio [AOR] = 2.2 for fistula placement, per 2 times greater number of fistulae placed during training, P < 0.0001) and degree of emphasis on vascular access creation during training (AOR = 2.4 for fistula placement, for much-to-extreme emphasis vs. no emphasis, P = 0.0008). Risk of primary fistula failure was 34% lower (relative risk = 0.66, P = 0.002) when placed by surgeons who created > or = 25 (vs. < 25) fistulae during training. CONCLUSIONS: Surgical training is key to both fistula placement and survival, yet US surgical programs seem to place less emphasis on fistula creation than those in other countries. Enhancing surgical training in fistula creation would help meet targets of the Fistula First Initiative.

Sleep quality predicts quality of life and mortality risk in haemodialysis patients: results from the Dialysis Outcomes and Practice Patterns Study (DOPPS).

BACKGROUND: Poor sleep quality (SQ) affects many haemodialysis (HD) patients and could potentially predict their morbidity, mortality, quality of life (QOL) and patterns of medication use. METHODS: Data on SQ were collected from 11,351 patients in 308 dialysis units in seven countries in the Dialysis Outcomes and Practice Patterns Study (DOPPS) between 1996 and 2001 through a patient self-reported SQ scale, ranging from 0 (worst) to 10 (best). A score of <6 reflected poor SQ. Sleep disturbance was also assessed by self-reported daytime sleepiness, feeling drained and nocturnal awakening. Logistic and multiple linear regression were used to assess predictors of SQ and associations with QOL. Cox regression examined associations with mortality. Analyses accounted for case-mix, facility clustering and country. RESULTS: Nearly half (49%) of patients experienced poor SQ. Mean SQ scores varied by country, ranging from 4.9 in Germany to 6.5 in Japan. Patients with poor SQ were more likely to be prescribed antihistamines, antidepressants, anti-inflammatories, narcotics, gastrointestinal (GI) medications, anti-asthmatics or hypnotics. Physical exercise at least once a week (vs < once a week) was associated with lower odds of poor SQ (AOR = 0.55-0.85, P < 0.05). Poorer SQ was associated with significantly lower mental and physical component summary (MCS/PCS) scores (MCS scores 1.9-13.2 points lower and PCS scores 1.5-7.7 points lower when SQ scores were <10 vs 10). The RR of mortality was 16% higher for HD patients with poor SQ. CONCLUSIONS: Poor SQ is common among HD patients in DOPPS countries and is independently associated with several QOL indices, medication use patterns and mortality. Assessment and management of SQ should be an important component of care.

Lack of appetite in haemodialysis patients--associations with patient characteristics, indicators of nutritional status and outcomes in the international DOPPS.

BACKGROUND: Identification of haemodialysis patients with problems related to lack of appetite should help prevent adverse outcomes. We studied whether a single question about being bothered by lack of appetite within the prior 4 weeks is related to nutritional status, inflammation and risks of death and hospitalization. Additionally, we assessed associations of lack of appetite with depression, dialysis dose and length of haemodialysis. METHODS: This study is an analysis of baseline and longitudinal data from 14 406 patients enrolled in the Dialysis Outcomes and Practice Pattern Study. Cox regression was used to assess whether the degree (not, somewhat, moderately, very much, extremely) that patients were bothered by lack of appetite is an independent predictor of death and hospitalization. Logistic regression was used to identify baseline characteristics associated with being bothered by lack of appetite. RESULTS: The risk of death was more than 2-fold higher [relative risk (RR) = 2.23; 95% confidence interval (CI) = 1.90-2.62] and the risk of hospitalization 33% higher (RR = 1.33; 95% CI = 1.19-1.48) among patients extremely bothered, compared with not bothered, by lack of appetite. These associations followed a dose-response fashion and remained statistically significant after adjustments for 14 comorbidities. Depression, shorter haemodialysis session, hypoalbuminaemia, lower concentration of serum creatinine and normalized protein catabolic rate, lower body mass index and higher leucocyte and neutrophil counts were independently associated with higher odds of being bothered by lack of appetite. CONCLUSIONS: The data suggest that a single question about lack of appetite helps identify haemodialysis patients with poorer nutritional status, inflammation, depression and higher risks of hospitalization and death. The study calls attention to a possible beneficial effect of longer haemodialysis on appetite.

Sexual dysfunction in dialysis patients treated with antihypertensive or antidepressive medications: results from the DOPPS.

BACKGROUND: The relationship between medication prescription and sexual dysfunction (SD) in dialysis patients is unclear. METHODS: We studied antihypertensive and antidepressive agents prescribed for 7346 patients in the Dialysis Outcomes and Practice Patterns Study phase 1 (DOPPS I) and 8891 patients in DOPPS II. At baseline, DOPPS I patients completed a quality of life survey, including four questions about sexual functioning, from which we created a composite SD scale. DOPPS II patients were asked only one question about SD. We examined predictors of SD with logistic regression, using numerous patient characteristics, comorbid conditions and additional variables. RESULTS: Reported SD ranged from 66.4% (France) to 84.5% (Spain). The mean composite SD score ranged from 6.4 (Spain) to 7.9 (Germany) (on a 3-15 scale). Peripheral alpha-blockers increased odds of DOPPS I patients having their sex life bothered by end-stage renal disease (ESRD) (OR=1.18), and there were elevated odds of arousal problems with central antagonists, loop diuretics and peripheral alpha-blockers (OR=1.19, 1.24 and 1.29, respectively). Selective serotonin reuptake inhibitors (SSRIs) and benzodiazepines increased odds of problems with enjoyment (OR=1.59 and 1.26, respectively) and arousal (OR=1.70 and 1.24, respectively), and having sex life bothered by ESRD (DOPPS I: OR=1.36 and 1.24; DOPPS II: 1.30 and 1.31, respectively). Vasodilators reduced the odds of sexual enjoyment problems (OR=0.75). Composite SD scores worsened with peripheral alpha-blockers (+0.41), tricyclics (+0.78), SSRIs (+0.80) and benzodiazepines (+0.50), but not with vasodilators (-0.57). CONCLUSIONS: Awareness of associations between SD and prescribed medications may offer opportunities for intervention.

Pruritus in haemodialysis patients: International results from the Dialysis Outcomes and Practice Patterns Study (DOPPS).

BACKGROUND: Pruritus affects many haemodialysis (HD) patients. In this study, pruritus and its relationship to morbidity, mortality, quality of life (QoL), sleep quality and patient laboratory measures were analysed in >300 dialysis units in 12 countries. METHODS: Pruritus data were collected from 18 801 HD patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS) (1996-2004). Analyses were adjusted for age, gender, black race, Kt/V, haemoglobin, serum albumin, albumin-corrected serum calcium, serum phosphorus, 13 comorbidities, depression, years on dialysis, country and facility clustering effects. RESULTS: Moderate to extreme pruritus was experienced by 42% of prevalent HD patients in DOPPS during 2002/2003. Many patient characteristics were significantly associated with pruritus, but this did not explain the large differences in pruritus between countries (ranging from 36% in France to 50% in the UK) and between facilities (5-75%). Pruritus was slightly less common in patients starting HD than in patients on dialysis >3 months. Pruritus in new end-stage renal disease (ESRD) patients likely results from pre-existing conditions and not haemodialysis per se, indicating the need to understand development of pruritus before ESRD. Patients with moderate to extreme pruritus were more likely to feel drained [adjusted odds ratio (AOR) = 2.3-5.2, P < 0.0001] and to have poor sleep quality (AOR = 1.9-4.1, P < or = 0.0002), physician-diagnosed depression (AOR = 1.3-1.7, P < or = 0.004), and QoL mental and physical composite scores 3.1-8.6 points lower (P < 0.0001) than patients with no/mild pruritus. Pruritus in HD patients was associated with a 17% higher mortality risk (P < 0.0001), which was no longer significant after adjusting for sleep quality measures. CONCLUSIONS: The pruritus/mortality relationship may be substantially attributed to poor sleep quality. The many poor outcomes associated with pruritus underscore the need for better therapeutic agents to provide relief for the 40-50% of HD patients affected by pruritus.

Large variations in prescriptions of gastrointestinal medications in hemodialysis patients on three continents: the Dialysis Outcomes and Practice Patterns Study (DOPPS).

Little is known about proton pump inhibitor (PPI) or H(2) receptor antagonist (HA) prescription patterns or regarding use of predictors in hemodialysis patients. Proton pump inhibitor and HA prescribing patterns were investigated in 8628 hemodialysis patients from seven countries enrolled in the prospective, observational Dialysis Outcomes and Practice Patterns Study. Logistic regression examined predictors associated with PPI and HA use, adjusting for age, sex, country, time with end-stage renal disease, medications, 14 comorbid conditions, and the association between the number of comorbid conditions and the prescription of gastrointestinal (GI) medications. In a cross-section from February 1, 2000, 3.4% to 36.9% of patients received an HA and 0.8% to 26.9% took a PPI, depending upon the country. From 1996 to 2001, the prescription of HAs declined while PPI use increased. Facility use of HAs and PPIs ranged from 0% to 94% of patients. H2 receptor antagonist or PPI use was significantly and independently associated with age, narcotic use, corticosteroids, acetaminophen, nonsteroidal anti-inflammatory drugs, tricyclic antidepressants, selective serotonin reuptake inhibitors, coronary artery disease history, cardiovascular diseases other than hypertension or congestive heart failure, peripheral vascular disease, pulmonary disease, and GI bleed. Proton pump inhibitors or HAs were more likely to be prescribed in Italy, Spain, and the United Kingdom than in the United States. The odds of PPI prescription increased if serum phosphorus <5.5 mEq/L or serum albumin <3.5 g/dL. Prescription of GI medications was associated with many comorbidities and use of several medications. Extreme variability of prescription patterns suggests that there is no standard approach in treatment practices.

Haemodialysis vascular access problems in Canada: results from the Dialysis Outcomes and Practice Patterns Study (DOPPS II).

BACKGROUND: The optimal vascular access for chronic maintenance haemodialysis (HD) is the native arteriovenous fistula (AVF). Vascular access practice patterns are reported for a Canadian cohort of patients from the Dialysis Outcomes and Practice Patterns Study (DOPPS II). METHODS: DOPPS II is a prospective, observational study in 12 countries, including Canada. A representative random sample of 20 Canadian HD facilities and patients within those units were studied during 2002-2004. Canadian results were compared with those found in Europe and the USA. RESULTS: AVF use in Canadian prevalent (53%) and incident (26%) patients was lower than Canadian guidelines recommend (60%), and lower than in Europe [prevalent (74%), incident (50%)]. Despite 85% of Canadian HD patients having seen a nephrologist for > 1 month prior to starting dialysis, central venous catheter use in Canada (33% in prevalent patients, 70% in incident patients) was much higher than in Europe (prevalent 18%, incident 46%) and slightly higher than in the USA (prevalent 25%, incident 66%). This pattern is contrary to the preferences of Canadian medical directors and vascular access surgeons. The typical time from referral until permanent vascular access creation is substantially longer in Canada (61.7 days) than in Europe (29.4 days) or the USA (16 days). This longer delay time and higher catheter use in Canada may be a consequence of the significantly lower number of access surgeons per 100 HD patients in Canada (2.9) compared with the USA (8.1) and Europe (4.6). Furthermore, the median hours per week devoted to vascular access-related surgery per 100 patients is substantially lower in Canada (0.027 h) compared with the USA (0.082 h) and Europe (0.059 h). CONCLUSION: These findings suggest that Canadian chronic HD patients often rely on central venous catheters for vascular access, despite their known association with numerous detrimental outcomes in HD. Nephrologists, vascular access surgeons, interventional radiologists, other physicians and health care funding bodies must be more broadly educated about the priority of AVF creation as the preferred vascular access for chronic HD patients. They must work together to secure both the human and financial resources and other health care system enhancements to increase AVF creation rates in a timely manner.