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Introduction: Integrated service delivery is considered to be an essential condition for improving the management and health outcomes of people with chronic kidney disease (CKD). However, research on the assessment of integrated care by patients and care providers is hindered by the absence of brief, reliable, and valid measurement tools. Objective: The aim of this study was to develop survey instruments for healthcare professionals and patients based on the Rainbow Model of Integrated Care (RMIC), and to evaluate their psychometric properties. Design: The development process was based on the US Food and Drug Administration guidelines. This included item generation from systematic reviews of existing tools and expert opinion on clarity and content validity, involving renal care providers and chronic kidney patients. A cross-sectional, multi-centre design was used to test for internal consistency and construct validity. Setting: Outpatient clinics in a large renal network. Participants: A sample of 30.788 CKD patients, and 8.914 renal care providers. Methods and analysis: Both survey instruments were developed using previous qualitative work and published literature. A multidisciplinary expert panel assessed the face and content validity of both instruments and following a pilot study, the psychometric properties of both instruments were explored. Exploratory factor analysis with principal axis factoring and with promax rotation was used to assess the underlying dimensions of both instruments; Cronbach’s alpha was used to determine the internal constancy reliability. Results: 17.512 patients (response rate: 56.9%) and 8.849 care providers (response rate: 69.5%) responded to the questionnaires. Factor analysis of the patient questionnaire yielded three internally consistent (Cronbach’s alpha > 0.7) factors: person-centeredness, clinical coordination, and professional coordination. Factor analysis of the provider questionnaire produced eight internally consistent (Cronbach’s alpha > 0.7) factors: person-centeredness, community centeredness, clinical coordination, professional coordination, organisational coordination, system coordination, technical and cultural competence. As hypothesised, care coordination patient and providers scores significantly correlated with questions about quality of care, treatment involvement, reported health, clinics’ organisational readiness, and external care coordination capacity. Conclusion: This study provides evidence for the reliability and validity of the RMIC patient and provider questionnaires as generic tools to assess the experience with or perception of integrated renal care delivery. The instruments are recommended in future applications testing test-retest reliability, convergent and predictive validity, and responsiveness. [ABSTRACT FROM AUTHOR]

Sexual dysfunction may affect 80% of women in hemodialysis. However the specific patterns and clinical correlates of sexual functioning remain poorly described. The aim of this study was to assess prevalence and correlates of the individual domains of sexual functioning in women treated with hemodialysis. We recruited, into this multinational cross-sectional study, women treated with long-term hemodialysis (Collaborative Working Group on Depression and Sexual dysfunction in Hemodialysis study). Self-reported domains of sexual functioning were assessed by the Female Sexual Function Index, which is routinely administered within the network of dialysis patients followed by the working group. Lower scores represented lower sexual functioning. Socio-demographic and clinical correlates of each domain of sexual functioning were identified by stepwise multivariable linear regression. Sensitivity analyses were restricted to women who reported being sexually active. We found that of 1309 enrolled women, 659 (50.3%) provided complete responses to FSFI survey questions and 232 (35%) reported being sexually active. Overall, most respondents reported either no sexual activity or low sexual functioning in all measured domains (orgasm 75.1%; arousal 64.0%; lubrication 63.3%; pain 60.7%; satisfaction 60.1%; sexual desire 58.0%). Respondents who were waitlisted for a kidney transplant reported scores with higher sexual functioning, while older respondents reported scores with lower functioning. The presence of depression was associated with worse lubrication and pain scores [mean difference for depressed versus non-depressed women (95% CI) -0.42 (-0.73 to -0.11), -0.53 (-0.89 to -0.16), respectively] while women who had experienced a previous cardiovascular event reported higher pain scores [-0.77 (-1.40- to -0.13)]. In conclusion, women in hemodialysis reported scores consistent with marked low sexual functioning across a range of domains; the low functioning appeared to be associated with comorbidity. [ABSTRACT FROM AUTHOR]

The increased risks of death and adverse events with erythropoiesis-stimulating agent (ESA) therapy targeting a higher hemoglobin level are established. It is uncertain whether the adverse effects of ESA therapy are related to dose and are mitigated when a fixed low ESA dose is used. We conducted a multicenter, prospective randomized open-label, blinded-endpoint (PROBE) trial to evaluate fixed low versus high dose ESA therapy on patient outcomes. We intended to recruit 2104 hemodialysis patients >18 years with anemia or receiving ESA treated at dialysis clinics in Italy. The intervention was fixed low (4000 IU epoetin alfa equivalent weekly) or high (18,000 IU epoetin alfa equivalent weekly) dose ESA for 12 months. Primary outcomes were serum transferrin, ferritin, albumin, C-reactive protein and ESA dose. Secondary outcomes were the composite of death or cardiovascular event, all-cause mortality, cardiovascular mortality, myocardial infarction, stroke, cardiovascular hospitalization, and quality of life. Study recruitment was terminated after inclusion of 656 participants with convergence of ESA dose between groups during follow up. Fixed low dose ESA had uncertain effects on serum ferritin (delta of delta (DD) 3.9 ng/ml, 95% CI -85.0 to 92.8), transferrin (9.2 mg/dl, -6.3 to 24.8), transferrin saturation (3.7%, -5.0 to 12.3), serum albumin (-0.03 g/dl, -0.2 to 0.1), or C-reactive protein (-0.6 mg/l, -3.3 to 2.1). In addition, fixed dose therapy had inconclusive effects on the composite endpoint of mortality and cardiovascular events (hazard ratio [HR] 0.95, 95% CI 0.66 to 1.37), death (0.98, 0.64 to 1.52), nonfatal myocardial infarction (0.52, 0.18 to 1.52), nonfatal stroke (no events), hospital admission for cardiovascular causes (0.93, 0.50 to 1.72) or health-related quality of life. A fixed low ESA dose in hemodialysis patients has uncertain effects on serum parameters, mortality, cardiovascular events, and quality of life. Hemoglobin targets may be so entrenched in nephrology practice that a trial of ESA dose is no longer possible. [ABSTRACT FROM AUTHOR]