Measuring performance in allied health professional role substitution models of care: a clinician survey.

BACKGROUND: Professional role substitution models of care have emerged as a key strategy to address increasing healthcare demand. Gaining insights from those actively engaged in the process of these models' implementation and evaluation is pivotal to ensuring sustainability and further successful implementation. The purpose of this study was to describe allied-health clinicians' perceptions, practice, and experiences of healthcare performance evaluation in professional role substitution models of care. METHODS: Data were collected via an online platform between 22 June - 22 July 2022 using a combination of convenience and network-based sampling of allied-health clinicians involved or interested in the implementation and evaluation of professional role substitution models of care. Clinicians answered 25 questions which consisted of demographic and targeted questions regarding performance evaluation across six domains of healthcare quality (effectiveness, safety, appropriateness, access & equity, continuity of care, and cost, efficiency, productivity & sustainability). RESULTS: A total of 102 clinicians accessed the survey, with 72 providing complete survey data. Eleven allied-health professions were represented, working across twelve specialities in thirteen hospital and health services. Whilst most allied-health clinicians (93-100%) supported measuring performance in each of the six healthcare quality domains, only 26-58% were measuring these domains in practice. Allied-health leadership support (62.5%), clinician drive (62.5%), consumer engagement (50%) and medical support (46%) were enablers whilst a lack of resources (human, time, financial (47%)), healthcare performance frameworks and/or policies (40%) were identified as barriers. Given the opportunity, clinicians would invest the most financial resources in digital solutions as a core strategy to improve performance evaluation. CONCLUSIONS: Allied-health professionals expressed strong support for principles of performance evaluation, however in practice, performance evaluation is still in its infancy in professional role substitution models of care. Organisations can implement strategies that maximise the enablers whilst addressing barriers identified to improve performance evaluation in these models of care.

What is 'successful rehabilitation'? A multi-stakeholder nominal group technique study to inform rehabilitation outcome measurement.

OBJECTIVE: To explore how stakeholders in rehabilitation conceptualise 'successful rehabilitation', to inform the development of a minimum dataset and core outcomes for sub-acute rehabilitation. DESIGN: Qualitative consensus study using the nominal group technique. SETTING: Online focus groups. PARTICIPANTS: Consumer representatives (n = 7), clinicians (n = 15), and health service managers (n = 9) from Australia. INTERVENTION: Participants responded to the question, 'What does successful rehabilitation look like?'. Following item generation, they prioritised their top five responses, allocating 100 points across items to denote relative importance. MAIN MEASURES: Prioritised responses were analysed across stakeholder groups using qualitative content analysis. RESULTS: Ten themes were identified. 'Successful rehabilitation' is: (1) person and family centred; (2) effective; (3) inter-professional; (4) accessible; (5) goal oriented with meaningful outcomes; (6) connected to the continuum of care; (7) evidence-based and supportive of innovation and research; (8) appropriately funded and skilled; (9) satisfying and engaging; and (10) safe. CONCLUSIONS: Stakeholder-defined 'successful rehabilitation' aligned with principles of value-based care and evidence-based rehabilitation. Provision and receipt of person and family centred care was the most important indicator of successful rehabilitation. Measures of success should include indicators of structure, process, outcome, and experience, and be conducted at multiple time-points.

Effectiveness of dietary interventions delivered by digital health to adults with chronic conditions: Systematic review and meta-analysis.

BACKGROUND: Digital health interventions may facilitate management of chronic conditions; however, no reviews have systematically assessed the effectiveness of dietary interventions delivered by digital health platforms for improving dietary intake and clinical outcomes for adults with diet-related chronic conditions. METHODS: Databases CINAHL, CENTRAL, Embase and MEDLINE were searched from inception to April 2021 to identify controlled trials for dietary education delivered by digital health (mobile or electronic health) to adults with diet-related chronic conditions. Random effects analysis was performed for diet quality, food groups, nutrients and clinical outcomes. Screening, data extraction and quality checking were completed in duplicate. RESULTS: Thirty-nine studies were included involving 7333 participants. Significant changes were found for Mediterranean diet adherence score (standardised mean difference [SMD] = 0.79; 95% confidence interval [CI] = 0.18 to 1.40), overall fruit and vegetable intake (mean difference [MD]: 0.63 serves/day; 95% CI = 0.27-0.98), fruit intake alone (MD = 0.58 serves/day; 95% CI = 0.39 to 0.77) and sodium intake (SMD = -0.22; 95% CI = -0.44 to -0.01). Improvements were also found for waist circumference [MD = -2.24 centimetres; 95% CI = -4.14 to -0.33], body weight (MD = -1.94 kg; 95% CI = -2.63 to -1.24) and haemoglobin A1c (MD = -0.17%; 95% CI = -0.29 to -0.04). Validity of digital assessment tools to measure dietary intake were not reported. The quality of evidence was considered to have low to moderate certainty. CONCLUSIONS: Modest improvements in diet and clinical outcomes may result from intervention via digital health for those with diet-related chronic conditions. However, additional robust trials with better reporting of digital dietary assessment tools are needed to support implementation within clinical practice.

Consumers' Perspectives and Experiences of Prebiotics and Probiotics for Gut Health in Chronic Kidney Disease.

OBJECTIVES: Nutrition supplementation, including prebiotics and probiotics, is a therapeutic strategy for modulating the gut microbiome in chronic kidney disease (CKD). However, the acceptability of gut-targeted supplements in this population remains largely unexplored. This study aims to describe the perceptions of nutrition supplementation, and the acceptability and experiences of pre- and probiotics in adults with Stage 3-4 CKD. DESIGN AND METHODS: Semi-structured interview study of adults with Stage 3-4 CKD (n = 30), aged 41-80 (mean 68) years, who completed a 12-month prebiotic and probiotic intervention or placebo, were interviewed between January and March 2019. Interviews were transcribed verbatim and analyzed thematically. RESULTS: Five themes were identified: integrating and sustaining routine supplementation (flexibility in prescription of prebiotics and probiotics, fitting in with regular routines); striving for health benefits (hoping to improve kidney health, hoping to improve general health, confirming health benefits); facilitating pre- and probiotic supplementation (perceiving pre- and probiotics as safe, side-effects from taking pre- and probiotics); empowering knowledge (valuing the opportunity to increase knowledge of gut health); and considerations for future use (questioning credibility of health claims, average palatability of prebiotic powder, cost concerns). CONCLUSIONS: Adults with Stage 3-4 CKD found pre- and probiotic supplements to be acceptable and complementary gut-targeted supplements. Individual preferences for nutrition supplementation should be considered alongside health knowledge to enhance uptake and adherence in practice.

Are Digital Health Technologies and Models of Nutrition Care the Future of Chronic Kidney Disease Management?

People living with chronic kidney disease (CKD) require long-term support at varying levels of individualization, intensity, and frequency. Mobile and digital models of nutrition care can facilitate long-term behavior change, address nutrition issues proactively, reduce travel burden, and reach people without access to health care more easily. However, while traditional health delivery continues to be digitally disrupted, there are many barriers to address before mobile and digitally supported models of nutrition care can become business as usual in nephrology and nutrition care practice. This paper overviews the current evidence base concerning the past and present mobile and digital health programs to improve nutrition in CKD and highlights the novel future trends in this field. The way nutrition and dietetic care can be feasible, safe, and potentially effective when delivered using various digital and virtual technologies, including consultations, assessments, establishment of diagnoses, formulation of plans, and monitoring/reviewing clinical progress is discussed. Of the available evidence to date, these modalities appear to improve dietary sodium intake and diet quality, self-efficacy, interdialytic weight gain, and body weight. Many barriers exist to sustaining the continued and widespread adoption of digital and mobile health-supported nutrition care in CKD. These include patient-, clinician-, and health system-specific and are discussed in detail. Mobile and digital-supported models of nutrition care present an exciting opportunity to assist kidney dietitians deliver patient-centred nutrition care in CKD.

Multiplex Lateral Flow Assay and the Sample Preparation Method for the Simultaneous Detection of Three Marine Toxins.

A multiplex lateral flow immunoassay (LFA) has been developed to detect the primary marine biotoxin groups: amnesic shellfish poisoning toxins, paralytic shellfish poisoning toxins, and diarrhetic shellfish poisoning toxins. The performance characteristics of the multiplex LFA were evaluated for its suitability as a screening method for the detection of toxins in shellfish. The marine toxin-specific antibodies were class-specific, and there was no cross-reactivity between the three toxin groups. The test is capable of detecting all three marine toxin groups, with working ranges of 0.2-1.5, 2.5-65.0, and 8.2-140.3 ng/mL for okadaic acid, saxitoxin, and domoic acid, respectively. This allows the multiplex LFA to detect all three toxin groups at the EU regulatory limits, with a single sample extraction method and dilution volume. No matrix effects were observed on the performance of the LFA with mussel samples spiked with toxins. The developed LFA uses a simple and pocket-sized, portable Cube Reader to provide an accurate result. We also evaluated the use of this Cube Reader with commercially available monoplex lateral flow assays for marine toxins.

Interventions for improving health literacy in people with chronic kidney disease.

BACKGROUND: Low health literacy affects 25% of people with chronic kidney disease (CKD) and is associated with increased morbidity and death. Improving health literacy is a recognised priority, but effective interventions are not clear. OBJECTIVES: This review looked the benefits and harms of interventions for improving health literacy in people with CKD. SEARCH METHODS: We searched the Cochrane Kidney and Transplant Register of Studies up to 12 July 2022 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. We also searched MEDLINE (OVID) and EMBASE (OVID) for non-randomised studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and non-randomised studies that assessed interventions aimed at improving health literacy in people with CKD. DATA COLLECTION AND ANALYSIS: Two authors independently assessed studies for eligibility and performed risk of bias analysis. We classified studies as either interventions aimed at improving aspects of health literacy or interventions targeting a population of people with poor health literacy. The interventions were further sub-classified in terms of the type of intervention (educational, self-management training, or educational with self-management training). Results were expressed as mean difference (MD) or standardised mean difference (SMD) with 95% confidence intervals (CI) for continuous outcomes and risk ratios (RR) with 95% CI for dichotomous outcomes. MAIN RESULTS: We identified 120 studies (21,149 participants) which aimed to improve health literacy. There were 107 RCTs and 13 non-randomised studies. No studies targeted low literacy populations. For the RCTs, selection bias was low or unclear in 94% of studies, performance bias was high in 86% of studies, detection bias was high in 86% of studies reporting subjective outcomes and low in 93% of studies reporting objective outcomes. Attrition and other biases were low or unclear in 86% and 78% of studies, respectively. Compared to usual care, low certainty evidence showed educational interventions may increase kidney-related knowledge (14 RCTs, 2632 participants: SMD 0.99, 95% CI 0.69 to 1.32; I² = 94%). Data for self-care, self-efficacy, quality of life (QoL), death, estimated glomerular filtration rate (eGFR) and hospitalisations could not be pooled or was not reported. Compared to usual care, low-certainty evidence showed self-management interventions may improve self-efficacy (5 RCTs, 417 participants: SMD 0.58, 95% CI 0.13 to 1.03; I² = 74%) and QoL physical component score (3 RCTs, 131 participants: MD 4.02, 95% CI 1.09 to 6.94; I² = 0%). There was moderate-certainty evidence that self-management interventions probably did not slow the decline in eGFR after one year (3 RCTs, 855 participants: MD 1.53 mL/min/1.73 m², 95% CI -1.41 to 4.46; I² = 33%). Data for knowledge, self-care behaviour, death and hospitalisations could not be pooled or was not reported. Compared to usual care, low-certainty evidence showed educational with self-management interventions may increase knowledge (15 RCTs, 2185 participants: SMD 0.65, 95% CI 0.36 to 0.93; I² = 90%), improve self-care behaviour scores (4 RCTs, 913 participants: SMD 0.91, 95% CI 0.00 to 1.82; I² =97%), self-efficacy (8 RCTs, 687 participants: SMD 0.50, 95% CI 0.10 to 0.89; I² = 82%), improve QoL physical component score (3 RCTs, 2771 participants: MD 2.56, 95% CI 1.73 to 3.38; I² = 0%) and may make little or no difference to slowing the decline of eGFR (4 RCTs, 618 participants: MD 4.28 mL/min/1.73 m², 95% CI -0.03 to 8.85; I² = 43%). Moderate-certainty evidence shows educational with self-management interventions probably decreases the risk of death (any cause) (4 RCTs, 2801 participants: RR 0.73, 95% CI 0.53 to 1.02; I² = 0%). Data for hospitalisation could not be pooled. AUTHORS' CONCLUSIONS: Interventions to improve aspects of health literacy are a very broad category, including educational interventions, self-management interventions and educational with self-management interventions. Overall, this type of health literacy intervention is probably beneficial in this cohort however, due to methodological limitations and high heterogeneity in interventions and outcomes, the evidence is of low certainty.

Cost-effectiveness of a mobile phone text messaging program (KIDNEYTEXT) targeting dietary behaviours in people receiving haemodialysis.

BACKGROUND: There is little information available to inform the cost-effectiveness of eHealth interventions in improving patient health outcomes. A trial-based economic evaluation was undertaken aiming to inform the feasibility of conducting a mobile phone text messaging programme targeting dietary behaviours in people receiving haemodialysis. METHODS: A trial-based economic evaluation from a health system perspective of a 6-month pilot randomised controlled trial was undertaken. One hundred and thirty patients receiving haemodialysis from six dialysis units across Sydney, Australia, were enrolled into the KIDNEYTEXT study. Usual care (inperson dietary counselling) was compared with usual care plus three semi-personalised dietary mobile phone text messages per week over a 6-month period. The outcomes of this economic evaluation included: cost of intervention, cost-effectiveness and marginal effects on total costs. RESULTS: The cost of developing and maintaining the KIDNEYTEXT intervention was US $110 per participant. Total costs were US $1418 higher in the usual care arm compared to the intervention arm. The incremental benefits for quality-adjusted life adjusted years were 0.01 [95% confidence interval (CI) = -0.03 to 0.06] and dietary adherence (i.e., adherent to three or more dietary guidelines at 6 months) being 0.04 (95% CI = -0.15 to 0.24). The largest component of total costs was related to unplanned admissions to hospital. CONCLUSIONS: Mobile phone text messages targeting dietary behaviours may be cost saving, at the same time as maintaining similar or improved dietary behaviours. A larger trial with a longer follow-up time is warranted.

Diet Quality and Protein-Bound Uraemic Toxins: Investigation of Novel Risk Factors and the Role of Microbiome in Chronic Kidney Disease.

OBJECTIVE: This study aims to explore the associations between diet quality, uraemic toxins, and gastrointestinal microbiota in the chronic kidney disease (CKD) population. METHODS: This is a baseline cross-sectional study of adults with CKD participating in a randomized controlled trial of prebiotic and probiotic supplementation. Dietary intake was measured using a seven-day diet history method, administered by a specialist dietitian. Diet quality was assessed using plant-based diet index (PDI) (overall PDI, healthy PDI, and unhealthy PDI), food group analysis, protein intake, fiber intake, and dietary protein-to-fiber ratio. Serum uraemic toxins (free and total; indoxyl sulfate and p-cresyl sulfate) were determined by ultraperformance liquid chromatography. Gastrointestinal microbiota richness, diversity, composition, and functional capacity were analyzed via metagenomic sequencing. RESULTS: Sixty-eight adults [median age: 70 (interquartile range: 58-75) years, 66% male] with an estimated glomerular filtration rate of 34 ± 11 mL/min/1.73 m2 were included, with 40 participants completing the optional fecal substudy. Dietary fiber intake was associated with lower levels of total indoxyl sulfate, whereas the healthy plant-based diet index was associated with lower levels of free p-cresyl sulfate. A higher protein-to-fiber ratio was associated with an increased relative abundance of unclassified members of order Oscillospirales. Intake of vegetables and whole grains was correlated with Subdoligranulum formicile, whereas an unclassified Prevotella species was correlated with potatoes and food items considered discretionary, including sweet drinks, sweet desserts, and animal fats. CONCLUSIONS: Diet quality may influence uraemic toxin generation and gut microbiota diversity, composition, and function in adults with CKD. Well-designed dietary intervention studies targeting the production of uraemic toxins and exploring the impact on gut microbiome are warranted in the CKD population.

Prebiotic Supplementation in Kidney Transplant Recipients for Preventing Infections and Gastrointestinal Upset: A Randomized Controlled Feasibility Study.

OBJECTIVES: Modulating the large intestinal microbiome of kidney transplant recipients (KTRs) may reduce infectious complications. The aim of this study is to assess the feasibility of a randomized controlled trial of prebiotics in reducing infections and gastrointestinal symptoms in KTRs. (DESIGN) AND METHODS: Acute KTRs were recruited to a double-blind, placebo-controlled, randomized trial at a single kidney transplant center. Patients were provided with prebiotics or placebo for 7 weeks. The primary outcome was feasibility, defined as recruitment of ≥80% of eligible people within 6 months. Secondary outcomes included adherence and tolerability, participant retention in trial, proportions of participants providing serum and stool specimens, self-reported quality of life, gastrointestinal symptoms, and infection events. RESULTS: During the 7-week period, 72 patients met eligibility criteria, of whom 60 (83%) consented to participate (mean ± standard deviation age 53 ± 12 years; 62% males). Fifty-six (78%) participants were randomized (27 interventions and 29 controls). Although participants receiving intervention experienced reduced gastrointestinal symptoms (-0.28 [interquartile range, IQR -0.67 to 0.08] vs. -0.07 [IQR -0.27 to 0], P = .03), both control and intervention groups were similar in adherence (67% vs. 72%, P = .36), tolerability (56% vs. 62%, P = .64), quality of life (-0.2 [IQR -0.6 to 0] vs. -0.2 [IQR -0.8 to 0], P = .82), and infection events (33% vs. 34%, P = .83). Blood and stool samples were collected from ≥90% of participants in both groups. CONCLUSIONS: It is feasible to recruit and retain acute KTRs in a randomized, placebo-controlled trial examining the effect of prebiotics on infections and gastrointestinal symptoms. This study also showed that prebiotics significantly reduced gastrointestinal symptoms.

Relationship Between Dietary Phosphate Intake and Biomarkers of Bone and Mineral Metabolism in Australian Adults With Chronic Kidney Disease.

OBJECTIVE: Higher serum phosphate is associated with increased adverse outcomes including cardiovascular disease. Abnormalities of bone and mineral metabolism in chronic kidney disease (CKD), including higher serum phosphate, are important risk factors for increased cardiovascular disease. Associations between dietary phosphate intake and biochemical and cardiovascular parameters in non-dialysis CKD patients, however, have not been adequately studied. This study aimed to explore associations between phosphate intake and biomarkers of bone and mineral metabolism and intermediate cardiovascular markers in adults with stage 3-4 CKD. DESIGN AND METHODS: One hundred thirty-two participants enrolled in the IMpact of Phosphate Reduction On Vascular End-points in Chronic Kidney Disease trial were invited to participate in this sub-study. At baseline, dietary phosphate intake and its source (animal, plant, or a mixture of animal and plant) were determined using a 7-day self-administered diet food record, and measurements were made of serum and urinary phosphate, serum calcium, parathyroid hormone, fibroblast growth factor-23, and the intermediate cardiovascular markers pulse wave velocity (PWV) and abdominal aortic calcification. The relationships between dietary phosphate intake and these bone metabolism and cardiovascular markers were explored using Pearson's correlation and linear regression. The effect of source of phosphate intake was analyzed using compositional data analysis. RESULTS: Ninety participants (age 64 ± 12 years, 68% male, estimated glomerular filtration rate 26.6 ± 7.6 mL/min/1.73 m2, daily phosphate intake 1,544 ± 347 mg) completed the study. Correlations among dietary phosphate intake and biochemical measures, PWV, and abdominal aortic calcification ranged from r = -0.13 to r = +0.13. Linear regression showed no association between dietary phosphate measurements and biochemical or cardiovascular parameters. Source of phosphate intake was associated with PWV (P = .01), but not with other biomarkers of bone and mineral metabolism. Higher PWV values were associated with higher intake of plant-based relative to animal-based phosphate (1.058 [1.020-1.098], P = .003). CONCLUSION: Levels of total dietary phosphate intake measured by dietary food record show no statistically significant relationship with biochemical markers of bone and mineral metabolism or intermediate cardiovascular markers. Higher PWV levels associated with higher intake of plant-based relative to animal-based phosphate intake were an unexpected finding and further research is needed in this area.

Modifiable Lifestyle Factors for Primary Prevention of CKD: A Systematic Review and Meta-Analysis.

BACKGROUND: Despite increasing incidence of CKD, no evidence-based lifestyle recommendations for CKD primary prevention apparently exist. METHODS: To evaluate the consistency of evidence associating modifiable lifestyle factors and CKD incidence, we searched MEDLINE, Embase, CINAHL, and references from eligible studies from database inception through June 2019. We included cohort studies of adults without CKD at baseline that reported lifestyle exposures (diet, physical activity, alcohol consumption, and tobacco smoking). The primary outcome was incident CKD (eGFR<60 ml/min per 1.73 m2). Secondary outcomes included other CKD surrogate measures (RRT, GFR decline, and albuminuria). RESULTS: We identified 104 studies of 2,755,719 participants with generally a low risk of bias. Higher dietary potassium intake associated with significantly decreased odds of CKD (odds ratio [OR], 0.78; 95% confidence interval [95% CI], 0.65 to 0.94), as did higher vegetable intake (OR, 0.79; 95% CI, 0.70 to 0.90); higher salt intake associated with significantly increased odds of CKD (OR, 1.21; 95% CI, 1.06 to 1.38). Being physically active versus sedentary associated with lower odds of CKD (OR, 0.82; 95% CI, 0.69 to 0.98). Current and former smokers had significantly increased odds of CKD compared with never smokers (OR, 1.18; 95% CI, 1.10 to 1.27). Compared with no consumption, moderate consumption of alcohol associated with reduced risk of CKD (relative risk, 0.86; 95% CI, 0.79 to 0.93). These associations were consistent, but evidence was predominantly of low to very low certainty. Results for secondary outcomes were consistent with the primary finding. CONCLUSIONS: These findings identify modifiable lifestyle factors that consistently predict the incidence of CKD in the community and may inform both public health recommendations and clinical practice.

Working with People Presenting with Symptoms of Borderline Personality Disorder: The Attitudes, Knowledge and Confidence of Mental Health Nurses in Crisis Response Roles in Australia.

Many people diagnosed with or presenting with borderline personality disorder (BPD) attend the emergency department (ED) when in crisis, and are often referred to mental health nurses for further assessment, and to arrange appropriate follow-up (MHNs). Little is known about the knowledge, skills, confidence and competence of MHNs working with this group in these specialist roles. This study sought to describe the attitudes of MHNs working in EDs and crisis services towards people who present with symptoms characteristic of BPD and to explore their knowledge of the diagnostic criteria of BPD. A descriptive survey tool comprised of 23 questions was adapted from a previously used survey with clinicians in a mental health service in Australia. Fifty-four nurses who identified as MHNs and were currently employed in EDs or crisis settings completed the survey online. These MHNs were found to hold positive attitudes towards people with BPD including being optimistic about recovery and treatment. The experience and education of MHNs now employed in EDs may have contributed to positive attitudes and self-reported confidence relative to other nurses. Further research ought to focus on how MHNs assist people with a diagnosis of BPD who present in crisis meet immediate needs and facilitate access to effective ongoing care and treatment.

A Text Messaging Intervention for Dietary Behaviors for People Receiving Maintenance Hemodialysis: A Feasibility Study of KIDNEYTEXT.

RATIONALE & OBJECTIVE: An important component of hemodialysis management involves delivery of complex dietary recommendations. The aim of this study was to determine the feasibility of a mobile phone text-message intervention to improve dietary behavior in people undergoing hemodialysis. STUDY DESIGN: Six-month randomized feasibility study. SETTING & PARTICIPANTS: Patients receiving maintenance hemodialysis across 2 health districts in Sydney, Australia. INTERVENTIONS: Participants randomized to the intervention received 3 text messages per week in addition to standard dietary care for 6 months. The usual care group received standard dietary care. OUTCOMES: The primary outcomes were feasibility measured using recruitment and retention rates, acceptability of the intervention, and adherence to dietary recommendations. Secondary exploratory outcomes included information on certain clinical parameters related to dietary management of patients receiving maintenance hemodialysis. RESULTS: 130 people were recruited; 48% of eligible patients (130 of 272) consented to participate, and 88% (115 of 130) completed the study. Semistructured interviews evaluating acceptability identified 5 themes: clear and comprehensive, engaging with consistent and relevant content, maintaining attention with timely reminders, sustaining interest through ongoing care, and generic messages inadequate to prompt dietary change. There was no difference in adherence to dietary recommendations across treatment groups (odds ratio, 1.21 [95% CI, 0.55-2.72]; P = 0.6). Secondary exploratory analyses suggested reductions in dietary intake of single nutrients (potassium, phosphorus, sodium, protein), interdialytic weight gain, and phosphate binder use among intervention participants compared with participants assigned to standard care. LIMITATIONS: Our feasibility study was of short duration. Adherence was based on self-reported data. Generalizability to populations receiving maintenance hemodialysis outside of an urban, Australian setting is unknown. CONCLUSIONS: A simple mobile phone text-messaging intervention was feasible and acceptable to patients. Further investigation of the impact on patient-reported and clinical outcomes is warranted. FUNDING: Funding for the study was provided by a Sydney Medical School Foundation Grant and the Centre for Transplant and Renal Research at Westmead Hospital. TRIAL REGISTRATION: Registered at Australian New Zealand Clinical Trials Registry with study number ACTRN12617001084370.

Incorporating digital platforms into nutritional care in chronic kidney disease.

Digital health is increasingly recognized for its value to enhance patient care and clinical care processes. People with chronic kidney disease often find dietary self-management challenging. There is promising evidence that digital health interventions can support people with chronic kidney disease to self-manage their diet, by providing more frequent access to nutritional information and dietitians and by facilitating regular monitoring and feedback. There is some emerging evidence of the impact of digital interventions in chronic kidney disease; however, more research is needed to provide meaningful interpretation of how digital interventions can enhance current practice. Importantly, a number of factors need to be considered when designing, developing, implementing, and evaluating the impact of digital interventions. Consideration of the nutrition service and patients' needs, motivation and digital literacy, type of digital intervention, and the ability to embed the digital intervention into current care processes are critical. This paper overviews the current literature on digital health and self-management, factors to consider when embedding digital interventions and platforms into nutrition care and practical considerations for designing and implementing digital health interventions to enhance the nutritional care of people with chronic kidney disease.

Altered dietary salt intake for people with chronic kidney disease.

BACKGROUND: Evidence indicates that reducing dietary salt may reduce the incidence of heart disease and delay decline in kidney function in people with chronic kidney disease (CKD). This is an update of a review first published in 2015. OBJECTIVES: To evaluate the benefits and harms of altering dietary salt for adults with CKD. SEARCH METHODS: We searched the Cochrane Kidney and Transplant Register of Studies up to 6 October 2020 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. SELECTION CRITERIA: Randomised controlled trials comparing two or more levels of salt intake in adults with any stage of CKD. DATA COLLECTION AND ANALYSIS: Two authors independently assessed studies for eligibility, conducted risk of bias evaluation and evaluated confidence in the evidence using GRADE. Results were summarised using random effects models as risk ratios (RR) for dichotomous outcomes or mean differences (MD) for continuous outcomes, with 95% confidence intervals (CI). MAIN RESULTS: We included 21 studies (1197 randomised participants), 12 in the earlier stages of CKD (779 randomised participants), seven in dialysis (363 randomised participants) and two in post-transplant (55 randomised participants). Selection bias was low in seven studies, high in one and unclear in 13. Performance and detection biases were low in four studies, high in two, and unclear in 15. Attrition and reporting biases were low in 10 studies, high in three and unclear in eight. Because duration of the included studies was too short (1 to 36 weeks) to test the effect of salt restriction on endpoints such as death, cardiovascular events or CKD progression, changes in salt intake on blood pressure and other secondary risk factors were examined. Reducing salt by mean -73.51 mmol/day (95% CI -92.76 to -54.27), equivalent to 4.2 g or 1690 mg sodium/day, reduced systolic/diastolic blood pressure by -6.91/-3.91 mm Hg (95% CI -8.82 to -4.99/-4.80 to -3.02; 19 studies, 1405 participants; high certainty evidence). Albuminuria was reduced by 36% (95% CI 26 to 44) in six studies, five of which were carried out in people in the earlier stages of CKD (MD -0.44, 95% CI -0.58 to -0.30; 501 participants; high certainty evidence). The evidence is very uncertain about the effect of lower salt intake on weight, as the weight change observed (-1.32 kg, 95% CI -1.94 to -0.70; 12 studies, 759 participants) may have been due to fluid volume, lean tissue, or body fat. Lower salt intake may reduce extracellular fluid volume in the earlier stages of CKD (-0.87 L, 95% CI -1.17 to -0.58; 3 studies; 187 participants; low certainty evidence). The evidence is very uncertain about the effect of lower salt intake on reduction in antihypertensive dose (RR 2.45, 95% CI 0.98 to 6.08; 8 studies; 754 participants). Lower salt intake may lead to  symptomatic hypotension (RR 6.70, 95% CI 2.40 to 18.69; 6 studies; 678 participants; moderate certainty evidence). Data were sparse for other types of adverse events. AUTHORS' CONCLUSIONS: We found high certainty evidence that salt reduction reduced blood pressure in people with CKD, and albuminuria in people with earlier stage CKD in the short-term. If such reductions could be maintained long-term, this effect may translate to clinically significant reductions in CKD progression and cardiovascular events. Research into the long-term effects of sodium-restricted diet for people with CKD is warranted.

Interventions for weight loss in people with chronic kidney disease who are overweight or obese.

BACKGROUND: Obesity and chronic kidney disease (CKD) are highly prevalent worldwide and result in substantial health care costs. Obesity is a predictor of incident CKD and progression to kidney failure. Whether weight loss interventions are safe and effective to impact on disease progression and clinical outcomes, such as death remains unclear. OBJECTIVES: This review aimed to evaluate the safety and efficacy of intentional weight loss interventions in overweight and obese adults with CKD; including those with end-stage kidney disease (ESKD) being treated with dialysis, kidney transplantation, or supportive care. SEARCH METHODS: We searched the Cochrane Kidney and Transplant Register of Studies up to 14 December 2020 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs of more than four weeks duration, reporting on intentional weight loss interventions, in individuals with any stage of CKD, designed to promote weight loss as one of their primary stated goals, in any health care setting. DATA COLLECTION AND ANALYSIS: Two authors independently assessed study eligibility and extracted data. We applied the Cochrane 'Risk of Bias' tool and used the GRADE process to assess the certainty of evidence. We estimated treatment effects using random-effects meta-analysis. Results were expressed as risk ratios (RR) for dichotomous outcomes together with 95% confidence intervals (CI) or mean differences (MD) or standardised mean difference (SMD) for continuous outcomes or in descriptive format when meta-analysis was not possible. MAIN RESULTS: We included 17 RCTs enrolling 988 overweight or obese adults with CKD. The weight loss interventions and comparators across studies varied. We categorised comparisons into three groups: any weight loss intervention versus usual care or control; any weight loss intervention versus dietary intervention; and surgical intervention versus non-surgical intervention. Methodological quality was varied, with many studies providing insufficient information to accurately judge the risk of bias. Death (any cause), cardiovascular events, successful kidney transplantation, nutritional status, cost effectiveness and economic analysis were not measured in any of the included studies. Across all 17 studies many clinical parameters, patient-centred outcomes, and adverse events were not measured limiting comparisons for these outcomes. In studies comparing any weight loss intervention to usual care or control, weight loss interventions may lead to weight loss or reduction in body weight post intervention (6 studies, 180 participants: MD -3.69 kg, 95% CI -5.82 to -1.57; follow-up: 5 weeks to 12 months, very low-certainty evidence). In very low certainty evidence any weight loss intervention had uncertain effects on body mass index (BMI) (4 studies, 100 participants: MD -2.18 kg/m², 95% CI -4.90 to 0.54), waist circumference (2 studies, 53 participants: MD 0.68 cm, 95% CI -7.6 to 6.24), proteinuria (4 studies, 84 participants: 0.29 g/day, 95% CI -0.76 to 0.18), systolic (4 studies, 139 participants: -3.45 mmHg, 95% CI -9.99 to 3.09) and diastolic blood pressure (4 studies, 139 participants: -2.02 mmHg, 95% CI -3.79 to 0.24). Any weight loss intervention made little or no difference to total cholesterol, high density lipoprotein cholesterol, and inflammation, but may lower low density lipoprotein cholesterol. There was little or no difference between any weight loss interventions (lifestyle or pharmacological) compared to dietary-only weight loss interventions for weight loss, BMI, waist circumference, proteinuria, and systolic blood pressure, however diastolic blood pressure was probably reduced. Furthermore, studies comparing the efficacy of different types of dietary interventions failed to find a specific dietary intervention to be superior for weight loss or a reduction in BMI. Surgical interventions probably reduced body weight (1 study, 11 participants: MD -29.50 kg, 95% CI -36.4 to -23.35), BMI (2 studies, 17 participants: MD -10.43 kg/m², 95% CI -13.58 to -7.29), and waist circumference (MD -30.00 cm, 95% CI -39.93 to -20.07) when compared to non-surgical weight loss interventions after 12 months of follow-up. Proteinuria and blood pressure were not reported. All results across all comparators should be interpreted with caution due to the small number of studies, very low quality of evidence and heterogeneity across interventions and comparators. AUTHORS' CONCLUSIONS: All types of weight loss interventions had uncertain effects on death and cardiovascular events among overweight and obese adults with CKD as no studies reported these outcome measures. Non-surgical weight loss interventions (predominately lifestyle) appear to be an effective treatment to reduce body weight, and LDL cholesterol. Surgical interventions probably reduce body weight, waist circumference, and fat mass. The current evidence is limited by the small number of included studies, as well as the significant heterogeneity and a high risk of bias in most studies.

Dietary Phosphate Consumption in Australians With Stages 3b and 4 Chronic Kidney Disease.

OBJECTIVE: Dietary phosphate modification is a common therapy to treat hyperphosphatemia in individuals with chronic kidney disease (CKD). However, current dietary intake and common food sources of phosphate typically consumed by individuals with CKD are not well characterized. This study examined a cohort of CKD patients to determine total dietary intake and common food sources of phosphate, including phosphate additives. DESIGN AND METHODS: Participants with CKD stages 3b and 4 recruited to a substudy of the "IMPROVE-CKD (IMpact of Phosphate Reduction On Vascular End-points in Chronic Kidney Disease) Study" completed a 7-day self-administered diet record at baseline. Diet histories were analyzed and daily phosphate intakes determined using FoodWorks V.9 (Xyris). The proportion of phosphate contributed by each food group was determined using the AUSNUT 2011-2013 Food Classification System. Ingredient lists of packaged food items consumed were reviewed to determine frequency of phosphate-based additives. RESULTS: Ninety participants (mean eGFR 26.5 mL/min/1.73 m2) completed this substudy. Mean phosphate intake of participants was 1544 ± 347 mg/day, with 96% of individuals exceeding the recommended daily intake of phosphate (1000 mg/day). The highest sources of dietary phosphate were milk-based products (25%) and meat and poultry products/dishes (25%). Phosphate-based food additives were identified in 39% (n = 331/845) of packaged foods consumed by participants. CONCLUSION: Dietary phosphate intakes of Australians with CKD are high and come from a variety of sources. Managing dietary phosphate intake requires a patient-centered, tailored approach with an emphasis on maintaining nutritional adequacy and awareness of phosphate additives.

A Randomized Trial on the Effect of Phosphate Reduction on Vascular End Points in CKD (IMPROVE-CKD).

BACKGROUND: Hyperphosphatemia is associated with increased fibroblast growth factor 23 (FGF23), arterial calcification, and cardiovascular mortality. Effects of phosphate-lowering medication on vascular calcification and arterial stiffness in CKD remain uncertain. METHODS: To assess the effects of non-calcium-based phosphate binders on intermediate cardiovascular markers, we conducted a multicenter, double-blind trial, randomizing 278 participants with stage 3b or 4 CKD and serum phosphate >1.00 mmol/L (3.10 mg/dl) to 500 mg lanthanum carbonate or matched placebo thrice daily for 96 weeks. We analyzed the primary outcome, carotid-femoral pulse wave velocity, using a linear mixed effects model for repeated measures. Secondary outcomes included abdominal aortic calcification and serum and urine markers of mineral metabolism. RESULTS: A total of 138 participants received lanthanum and 140 received placebo (mean age 63.1 years; 69% male, 64% White). Mean eGFR was 26.6 ml/min per 1.73 m2; 45% of participants had diabetes and 32% had cardiovascular disease. Mean serum phosphate was 1.25 mmol/L (3.87 mg/dl), mean pulse wave velocity was 10.8 m/s, and 81.3% had abdominal aortic calcification at baseline. At 96 weeks, pulse wave velocity did not differ significantly between groups, nor did abdominal aortic calcification, serum phosphate, parathyroid hormone, FGF23, and 24-hour urinary phosphate. Serious adverse events occurred in 63 (46%) participants prescribed lanthanum and 66 (47%) prescribed placebo. Although recruitment to target was not achieved, additional analysis suggested this was unlikely to have significantly affected the principle findings. CONCLUSIONS: In patients with stage 3b/4 CKD, treatment with lanthanum over 96 weeks did not affect arterial stiffness or aortic calcification compared with placebo. These findings do not support the role of intestinal phosphate binders to reduce cardiovascular risk in patients with CKD who have normophosphatemia. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: Australian Clinical Trials Registry, ACTRN12610000650099.

Current Trends and Challenges for Rapid SMART Diagnostics at Point-of-Site Testing for Marine Toxins.

In the past twenty years marine biotoxin analysis in routine regulatory monitoring has advanced significantly in Europe (EU) and other regions from the use of the mouse bioassay (MBA) towards the high-end analytical techniques such as high-performance liquid chromatography (HPLC) with tandem mass spectrometry (MS). Previously, acceptance of these advanced methods, in progressing away from the MBA, was hindered by a lack of commercial certified analytical standards for method development and validation. This has now been addressed whereby the availability of a wide range of analytical standards from several companies in the EU, North America and Asia has enhanced the development and validation of methods to the required regulatory standards. However, the cost of the high-end analytical equipment, lengthy procedures and the need for qualified personnel to perform analysis can still be a challenge for routine monitoring laboratories. In developing regions, aquaculture production is increasing and alternative inexpensive Sensitive, Measurable, Accurate and Real-Time (SMART) rapid point-of-site testing (POST) methods suitable for novice end users that can be validated and internationally accepted remain an objective for both regulators and the industry. The range of commercial testing kits on the market for marine toxin analysis remains limited and even more so those meeting the requirements for use in regulatory control. Individual assays include enzyme-linked immunosorbent assays (ELISA) and lateral flow membrane-based immunoassays (LFIA) for EU-regulated toxins, such as okadaic acid (OA) and dinophysistoxins (DTXs), saxitoxin (STX) and its analogues and domoic acid (DA) in the form of three separate tests offering varying costs and benefits for the industry. It can be observed from the literature that not only are developments and improvements ongoing for these assays, but there are also novel assays being developed using upcoming state-of-the-art biosensor technology. This review focuses on both currently available methods and recent advances in innovative methods for marine biotoxin testing and the end-user practicalities that need to be observed. Furthermore, it highlights trends that are influencing assay developments such as multiplexing capabilities and rapid POST, indicating potential detection methods that will shape the future market.