Medication adherence in randomized controlled trials evaluating cardiovascular or mortality outcomes in dialysis patients: A systematic review

Background: Medication non-adherence is common among renal dialysis patients. High degrees of non-adherence in randomized controlled trials (RCTs) can lead to failure to detect a true treatment effect. Cardio-protective pharmacological interventions have shown no consistent benefit in RCTs involving dialysis patients. Whether non-adherence contributes to this lack of efficacy is unknown. We aimed to investigate how medication adherence and drug discontinuation were assessed, reported and addressed in RCTs, evaluating cardiovascular or mortality outcomes in dialysis patients. Methods: Electronic database searches were performed in MEDLINE, EMBASE & Cochrane CENTRAL for RCTs published between 2005-2015, evaluating self-administered medications, in adult dialysis patients, which reported clinical cardiovascular or mortality endpoints, as primary or secondary outcomes. Study characteristics, outcomes, methods of measuring and reporting adherence, and data on study drug discontinuation were analyzed. Results: Of the 642 RCTs in dialysis patients, 22 trials (12 placebo controlled), which included 19,322 patients, were eligible. The trialed pharmacological interventions included anti-hypertensives, phosphate binders, lipid-lowering therapy, cardio-vascular medications, homocysteine lowering therapy, fish oil and calcimimetics. Medication adherence was reported in five trials with a mean of 81% (range: 65-92%) in the intervention arm and 84.5% (range: 82-87%) in the control arm. All the trials that reported adherence yielded negative study outcomes for the intervention. Study-drug discontinuation was reported in 21 trials (mean 33.2%; 95% CI, 22.0 to 44.5, in intervention and 28.8%; 95% CI, 16.8 to 40.8, in control). Trials with more than 20% study drug discontinuation, more often yielded negative study outcomes (p = 0.018). Non-adherence was included as a contributor to drug discontinuation in some studies, but the causes of discontinuation were not reported consistently between studies, and non-adherence was listed under different categories, thereby potentiating the misclassification of adherence. Conclusions: Reporting of medication adherence and study-drug discontinuation in RCTs investigating cardiovascular or mortality endpoints in dialysis patients are inconsistent, making it difficult to compare studies and evaluate their impact on outcomes. Recommendations for consistent reporting of non-adherence and causes of drug discontinuation in RCTs will therefore help to assess their impact on clinical outcomes

Renal stones First steps and keys to reducing recurrence

In patients with a renal stone, management aims to detect complications, triage to expectant observation or active intervention and identify any predisposing factors. Referral for active urological intervention or detailed metabolic evaluation may be indicated. Dietary and lifestyle interventions may help decrease the risk of recurrences

Prevalence Of Constipation In Patients With Advanced Kidney Disease

Background: For people on peritoneal dialysis (PD), constipation is associated with technique failure. For those on haemodialysis (HD), constipation has been associated with a reduction in quality of life. Objectives: The objectives of this study were to (i) determine the prevalence of functional constipation; (ii) compare patient perception of constipation with Rome III criteria for functional constipation; (iii) describe the prevalence of constipation and stool form using Bristol Stool Form Scale (BSFS); (iv) determine differences in bowel habit and stool form between those on dialysis compared to pre-dialysis; and (v) determine the diagnostic accuracy of self-perception and the Rome III criteria against the BSFS. A cross-sectional group of pre-dialysis (eGFR \u3c 15 ml/min) and dialysis patients were recruited. A total of 148 patients participated (98 HD, 21 PD and 21 pre-dialysis). Participants: Completed a questionnaire consisting of self-perception of the presence of constipation, simplified questions from the Rome III criteria for functional constipation, scored their stool form using the BSFS and reported laxative use. Results: The prevalence of constipation using the Rome III criteria was 12.3%; patient perception 46.3% and 25.7% using the BSFS. Prevalence differed according to the tool used. Conclusion: No single method alone is sufficient for accurately determining if a patient is constipated. Relying on patients\u27 self-perception may be unreliable. Ideally patient assessment of constipation should incorporate both the Rome III criteria and BSFS in a method such as the one designed as a result of this research. Further research is needed to assess its usability and practicality in clinical practice

Comparison of health literacy profile of patients with end-stage kidney disease on dialysis versus non-dialysis chronic kidney disease and the influencing factors: a cross-sectional study

Objectives: Lower health literacy (HL) is associated with poor outcomes in patients with kidney disease. Since HL matches the patient\u27s competencies with the complexities of the care package, the level of HL sufficient in earlier stages of chronic kidney disease (CKD) may be inadequate for patients with end-stage kidney disease (ESKD) on dialysis. We aimed to analyse the HL profile of patients with ESKD and non-dialysis CKD and examine if there were significant associations with covariates which could be targeted to address HL deficits, thereby improving patient outcomes. Design and setting: Cross-sectional study of patients with CKD and ESKD from a single Australian health district. Methods: We assessed the HL profile of 114 patients with CKD and 109 patients with ESKD using a 44-item multidomain Health Literacy Questionnaire (HLQ) and examined its association with demographic factors (age, gender, race), smoking, income, education, comorbidities, carer status, cognitive function and depression. Using multivariable logistic regression models, HL profiles of patients with CKD and ESKD were evaluated after adjusting for covariates. Results: Patients with ESKD had similar demographics and educational levels compared with patients with CKD. ESKD had significantly higher frequency of vascular disease, cognitive impairment and depression. Patients with ESKD had better HL scores for the social support domain (37.1% vs 19.5% in higher HLQ4 tertile, p=0.004), whereas all other HL domains including engagement with healthcare providers were comparable to CKD. Depression was independently associated with nearly all of the HL domains (HLQ1: OR 2.6, p=0.030; HLQ2: OR 7.9, p=\u3c0.001; HLQ3: OR 7.6, p\u3c0.001; HLQ4: OR 3.5, p=0.010; HLQ5: OR 8.9, p=0.001; HLQ6: OR 3.9, p=0.002; HLQ7: OR 4.8, p=0.001; HLQ8: OR 5.3, p=0.001) and education with HL domains relevant to processing health-related information (HLQ8: OR 2.6, p=0.008; HLQ9: OR 2.5, p=0.006). Conclusions: Despite very frequent interactions with health systems, patients with ESKD on dialysis did not have higher HL in engagement with health providers and most other HL domains, compared with patients with CKD. Strategies promoting patient-provider engagement and managing depression which strongly associates with lower HL may address the impact of HL deficits and favourably modify clinical outcomes in renal patients

A cross-sectional comparison of health literacy deficits among patients with chronic kidney disease

Inadequate health literacy in people with chronic kidney disease (CKD) is associated with poorer disease management and greater complications. There are limited data on the health literacy deficits of people with CKD. The aim of this study was to investigate the types and extent of health literacy deficits in patients with CKD using the multidimensional Health Literacy Management Scale (HeLMS) and to identify associations between patient characteristics and the domains of health literacy measured by the HeLMS. Invitations to participate were sent to patients with CKD attending the renal unit of a regional Australian hospital. These patients included predialysis, dialysis (peritoneal and hemodialysis), and kidney transplant patients. This study identified that inadequate health literacy-especially in the domains relating to attending to one\u27s health needs, understanding health information, social support, and socioeconomic factors-was common. Male gender and education level were significantly associated with inadequate health literacy. The type and extent of health literacy deficits varied among CKD groups, and transplant patients had more deficits than other CKD patient groups. This study provides useful information for health professionals treating patients with CKD, especially with regard to the design of self-management interventions and health information

Does a pilot resistance training exercise program for haemodialysis patients increase dietary intake and quality of life?

Objective: To determine the impact of progressive resistance training for haemodialysis patients on dietary intake, body composition and quality of life. Design: A pilot uncontrolled intervention study, with subjects recruited from two satellite haemodialysis units. Fourteen patients enrolled in the study, with six patients completing the full 24-week exercise program. Intervention: A thrice-weekly, individualised, progressive resistance training program was provided to eligible consenting patients. Patients performed upper and lower body training before and during their usual dialysis treatment for 24 weeks. Main outcome measures: Dietary intake and nutritional status was assessed using a diet history, the Appetite and Diet Assessment Tool (ADAT) and Subjective Global Assessment (SGA). Body composition was assessed using DEXA scan. Muscular endurance was assessed using standard assessment measures. Quality of life was assessed using the Short Form 36 (SF-36) Quality of Life Tool. Routine biochemical parameters were also recorded for all patients. Results: Compliance to the exercise program among completers was 95.7%. This program was associated with statistically significant improvements to muscle mass, upper body strength, social functioning and vitality. Mental health subcomponent scores significantly decreased after 24 weeks. Clinical but not statistically significant improvements to dietary intake, body fat and appetite were seen. Some biochemical parameters (calcium phosphate product, phosphate) also saw clinically significant improvements. Conclusion: A pilot resistance training was associated with improvements in body composition, dietary intake and quality of life

Comparison of the extent and pattern of cognitive impairment among predialysis, dialysis and transplant patients: a cross sectional study from Australia

Aim: The aim of this study was to compare the extent of cognitive impairment and the types of cognitive deficits in an Australian cohort of four patient groups with end stage kidney disease. Characteristics predicting the presence of cognitive impairment were also evaluated. Methods: Observational cross sectional study of one hundred and fifty five patients with end stage kidney disease recruited from a regional Australian renal unit. Eligible participants included those whose estimated Glomerular Filtration Rate was \u3c 30 ml/min per 1.73m2; were undertaking peritoneal or hemodialysis, or had received a kidney transplant. The Montreal Cognitive Assessment tool was used to screen the study participants for cognitive impairment and evaluate cognitive deficits. Cognitive impairment was defined as a total Montreal Cognitive Assessment tool score ≤24/30. Results: The extent of cognitive impairment varied between the four groups with end stage kidney disease. Factors predicting the presence of cognitive impairment included undertaking dialysis, age ≥65, male gender, and the presence of diabetes or cerebrovascular disease. Deficits in executive function, attention, language, visuospatial skills, memory and orientation were common amongst the study participants, and these deficits varied according to which end stage kidney disease group the participants were in. Limitations to the study included the cross sectional design and that the presence of confounders like depression were not recorded. Conclusion: The impact of disparities in the cognitive capabilities identified in this study are likely to be far reaching. Tailoring of education and self management programs to the cognitive deficits of individuals is required

Interdisciplinary lifestyle intervention for weight management in a community population (HealthTrack study): study design and baseline sample characteristics

Background Integrating professional expertise in diet, exercise and behavioural support may provide more effective preventive health services but this needs testing. We describe the design and baseline results of a trial in the Illawarra region of New South Wales, Australia. Methods The HealthTrack study is a 12 month randomised controlled trial testing effects of a novel interdisciplinary lifestyle intervention versus usual care. The study recruited overweight and obese adults 25-54 years resident in the Illawarra. Primary outcomes were weight, and secondary outcomes were disease risk factors (lipids, glucose, blood pressure), and behaviour (diet, activity, and psychological factors). Protocols, recruitment and baseline characteristics are reported. Results Between May 2014 and April 2015, 377 participants were recruited and randomised. The median age (IQR) of the mostly female sample (74%) was 45 (37-51) years. The sample comprised obese (BMI 32 (29-35) kg/m2) well educated (79% post school qualifications) non-smokers (96%). A high proportion reported suffering from anxiety (26.8%) and depression (33.7%). Metabolic syndrome was identified in 34.9% of the sample. Conclusions The HealthTrack study sample was recruited to test the effectiveness of an interdisciplinary approach to preventive healthcare in self-identified overweight adults in the Illawarra region. The profile of participants gives some indication of those likely to use services similar to the trial design

Strategies to improve dietary, fluid, dialysis or medication adherence in patients with end stage kidney disease on dialysis: A systematic review and meta-analysis of randomized intervention trials

BACKGROUND:In patients with end stage kidney disease (ESKD) on dialysis, treatment non-adherence is common and results in poor health outcomes. However, the clinical benefits of interventions to improve adherence in dialysis patients are difficult to evaluate since trialled interventions and reported outcomes are highly diverse/ heterogeneous. This review summarizes existing literature on randomized controlled trials (RCTs) evaluating adherence interventions in ESKD patients focusing on the intervention category, outcome efficacy and persistence of benefit beyond the intervention. METHODS:We performed electronic database searches in Medline, Embase & Cochrane CENTRAL upto 1st July 2018 for RCTs evaluating interventions to improve diet, fluid, medication or dialysis adherence in ESKD patients. Study characteristics including category of interventions, outcomes, efficacy and follow-up were assessed. Meta-analysis was used to compute pooled estimates of the effects on the commonest reported outcome measures. RESULTS:From 1311 citations, we included 36 RCTs (13 cluster-randomized trials), recruiting a total of 3510 dialysis patients (mean age 55.1 ± 5.8 years, males 58.1%). Overall risk of bias was 'high' for 24 and of 'some concern' for 12 studies. Most interventions (33 trials, 92%) addressed patient related factors, and included educational/cognitive (N = 11), behavioural / counselling (N = 4), psychological/affective (N = 4) interventions or a combination (N = 14) of the above. A majority of (28/36) RCTs showed improvement in some reported outcomes. Surrogate measures like changes in phosphate (N = 19) and inter-dialytic weight gain (N = 15) were the most common reported outcomes and both showed significant improvement in the meta-analysis. Sixteen trials reported follow-up (1-12 months) beyond intervention and the benefits waned or were absent in nine trials within 12 months post-intervention. CONCLUSIONS:Interventions to improve treatment adherence result in modest short-term benefits in surrogate outcome measures in dialysis patients, but significant improvements in trial design and outcome reporting are warranted to identify strategies that would achieve meaningful and sustainable clinical benefits. LIMITATIONS:Poor methodological quality of trials. Frequent use of surrogate outcomes measures. Low certainly of evidence

Treatment adherence in clinical trials evaluating cardiovascular or mortality outcomes in dialysis patients: a systematic review

Abstract of an oral presentation at the 51st Annual Scientific Meeting of the Australian and New Zealand Society of Nephrology, 7-9 September 2015, National Convention Centre, Canberra, Australia