Sirolimus conversion after heart transplant: risk factors for acute rejection and predictors of renal function response.

In a randomized, comparative study of cardiac transplant patients with mild-to-moderate renal insufficiency, conversion from calcineurin inhibitors (CNIs) to sirolimus improved renal function at 1 year versus continuing CNIs, with an attendant risk of biopsy-confirmed acute rejection (BCAR). Post hoc analyses were conducted to identify predictors of BCAR and GFR improvement associated with conversion. Patients with proteinuria >500 mg/day were excluded. Univariate and multivariate regression analyses tested 13 parameters for BCAR and six for GFR improvement. In 57 sirolimus-treated patients, mean daily mycophenolate mofetil (MMF) dose was lower in those with versus without BCAR (1000 vs. 1420 mg; p = 0.014). Receiver operating characteristic analysis identified MMF dose ≤1000 mg/day as the optimal cutoff to predict BCAR. Multivariate analysis confirmed low MMF dose (odds ratio: 9.94; p = 0.007) and non-white race (odds ratio: 15.3; p = 0.06) were independently associated with BCAR. GFR improvement was evaluated in intent-to-treat patients (n = 116). Significant interaction was detected between treatment effect and preexisting diabetes status (univariate p = 0.077; multivariate p = 0.022), indicating greater beneficial effect of sirolimus in those without preexisting diabetes. These findings suggest that sirolimus is more effective in improving GFR in patients without preexisting diabetes, and adequate MMF doses are needed for sirolimus conversion.

Interactive Health Communication Applications for people with chronic disease.

BACKGROUND: Interactive Health Communication Applications (IHCAs) are computer-based, usually web-based, information packages for patients that combine health information with at least one of social support, decision support, or behaviour change support. These are innovations in health care and their effects on health are uncertain. OBJECTIVES: To assess the effects of IHCAs for people with chronic disease. SEARCH STRATEGY: We designed a four-part search strategy. First, we searched electronic bibliographic databases for published work; second, we searched the grey literature; and third, we searched for ongoing and recently completed clinical trials in the appropriate databases. Finally, researchers of included studies were contacted, and reference lists from relevant primary and review articles were followed up. As IHCAs require relatively new technology, the search time period commenced at 1990, where possible, and ran until 31 December 2003. SELECTION CRITERIA: Randomised controlled trials (RCTs) of IHCAs for adults and children with chronic disease. DATA COLLECTION AND ANALYSIS: One reviewer screened abstracts for relevance. Two reviewers screened all candidate studies to determine eligibility, apply quality criteria, and extract data from included studies. Authors of included RCTs were contacted for missing data. Results of RCTs were pooled using random-effects model with standardised mean differences (SMDs) for continuous outcomes and odds ratios for binary outcomes; heterogeneity was assessed using the I(2 )statistic. MAIN RESULTS: We identified 24 RCTs involving 3739 participants which were included in the review.IHCAs had a significant positive effect on knowledge (SMD 0.46; 95% confidence interval (CI) 0.22 to 0.69), social support (SMD 0.35; 95% CI 0.18 to 0.52) and clinical outcomes (SMD 0.18; 95% CI 0.01 to 0.35). Results suggest it is more likely than not that IHCAs have a positive effect on self-efficacy (a person's belief in their capacity to carry out a specific action) (SMD 0.24; 95% CI 0.00 to 0.48). IHCAs had a significant positive effect on continuous behavioural outcomes (SMD 0.20; 95% CI 0.01 to 0.40). Binary behavioural outcomes also showed a positive effect for IHCAs, although this result was not statistically significant (OR 1.66; 95% CI 0.71 to 3.87). It was not possible to determine the effects of IHCAs on emotional or economic outcomes. AUTHORS' CONCLUSIONS: IHCAs appear to have largely positive effects on users, in that users tend to become more knowledgeable, feel better socially supported, and may have improved behavioural and clinical outcomes compared to non-users. There is a need for more high quality studies with large sample sizes to confirm these preliminary findings, to determine the best type and best way to deliver IHCAs, and to establish how IHCAs have their effects for different groups of people with chronic illness.

Interactive Health Communication Applications for people with chronic disease.

BACKGROUND: Interactive Health Communication Applications (IHCAs) are computer-based, usually web-based health information packages for patients that combine information with at least one of social support, decision support, or behaviour change support. These are innovations in health care and their effects on health are uncertain. OBJECTIVES: To assess the effects of IHCAs for people with chronic disease. SEARCH STRATEGY: We designed a four-part search strategy. First, we searched electronic bibliographic databases for published work; second, we searched the grey literature and third, we searched for ongoing and recently completed clinical trials in the appropriate databases. Finally, researchers of included studies were contacted, and reference lists from relevant primary and review articles were followed up. As IHCAs require relatively new technology, the search commenced at 1990 where possible. SELECTION CRITERIA: Randomised controlled trials (RCTs) of Interactive Health Communication Applications for adults and children with chronic disease. DATA COLLECTION AND ANALYSIS: One reviewer screened abstracts. Two reviewers screened all candidate studies to determine eligibility, apply quality criteria, and extract data from included studies. Authors of included RCTs were contacted for missing data. Results of RCTs were pooled using a random effects model and standardised mean differences (SMDs) were calculated to provide net effect sizes. MAIN RESULTS: We screened 24,757 unique citations and retrieved 958 papers for further assessment, yielding 28 RCTs involving 4042 participants. One of these had an inadequate method of concealment of allocation, and sensitivity analyses were performed to determine the effects of including or excluding these data in the meta-analyses. Results in the abstract are from the meta-analyses excluding data from this study.IHCAs were found to have a positive effect on knowledge (SMD 0.49; 95% confidence interval (CI) 0.14 to 0.84) and on social support (SMD 0.47; 95% CI 0.28 to 0.66). IHCAs were found to have no effect on self-efficacy (SMD 0.15; 95% CI -0.13 to 0.43) or behavioural outcomes (SMD -0.09; 95% CI -0.49 to 0.32). IHCAs had a negative effect on clinical outcomes (SMD -0.32; 95% CI -0.63 to -0.02). REVIEWERS' CONCLUSIONS: The number and range of IHCAs is increasing rapidly; however there is a shortage of high quality evaluative data. Consumers who wish to increase their knowledge or social support amongst people with a similar problem may find an IHCA helpful. However, consumers whose primary aim is to achieve optimal clinical outcomes should not use an IHCA at present. Further research is needed to determine the reason for this negative effect on clinical outcomes, whether an optimal IHCA can achieve behaviour change and improved health outcomes, and if so, what are the essential features of such an IHCA, and the extent to which they differ according to patient group or condition.