Qualitative analysis of stakeholder perspectives on engaging Latinx patients in kidney-related research

BackgroundLatinx individuals are disproportionally burdened by kidney diseases compared to non-Latinx White individuals and are underrepresented in kidney-related research. We aimed to describe stakeholder perspectives on Latinx patient engagement in kidney-related research.MethodsWe conducted a thematic analysis of two online moderated discussions and an interactive online survey with open-text responses involving participants (i.e. stakeholders), with personal and/or professional experiences with Latinx patients with kidney diseases and their families/caregivers.ResultsAmong the eight stakeholders (Female:75%; Latinx ethnicity:88%), there were three physicians, one nurse, one patient with kidney disease who received a kidney transplant, one policy maker, one Doctor of Philosophy, and one executive director of a non-profit health organization. We identified five themes. The majority of themes and their respective subthemes (in parentheses) reflected barriers to engagement: Lack of personal relevance (unable to relate to research staff and marketing resources, and unclear benefit of research to self, family, and community); fear and vulnerability (immigration concerns, stigma with seeking care, skepticism of Western medicine); logistical and financial barriers (limited opportunities to enroll in clinical trials, out-of-pocket costs, transportation issues); and distrust and asymmetry of power (related to limited English proficiency or health literacy, and provider bias). The last theme centered on stimulating interest and establishing trust in the research process.ConclusionsTo overcome barriers to engagement in kidney-related research and establish trust among potential Latinx research participants, stakeholders recommended employing cultural responsiveness and community-based strategies. These strategies can help identify local health priorities, enhance research recruitment and retention strategies, and establish partnerships that continue to elevate research endeavors aiming to enhance the health of Latinx individuals with kidney diseases

A viewpoint describing the American Society of Transplantation rationale to conduct a comprehensive patient survey assessing unmet immunosuppressive therapy needs

This viewpoint aims to set the stage and provide the rationale for the proposed development of a large-scale, comprehensive survey assessing transplant patients\u27 perceived unmet immunosuppressive therapy needs. Research in organ transplantation has historically focused on reducing the incidence and impact of rejection on allograft survival and minimizing or eliminating the need for chronic immunosuppressive therapies. There has been less emphasis and investment in therapies to improve patient-reported outcomes including health-related quality of life and side-effects. Patient-focused drug development (PFDD) is a new and important emphasis of the Food and Drug Administration (FDA) that provides a guiding philosophy for incorporating the patient experience into drug development and evaluation. The American Society of Transplantation (AST) Board of Directors commissioned this working group to prepare for the conduct of a comprehensive patient survey assessing unmet immunosuppressive therapy needs. This paper aims to describe the basis for why it is important to conduct this survey and briefly outline the plan for broad stakeholder engagement to ensure the information gained is diverse, inclusive, and relevant for advancing PFDD in organ transplant recipients

Validation of a Core Patient-Reported Outcome Measure for Life Participation in Kidney Transplant Recipients:the SONG Life Participation Instrument

IntroductionLife participation has been established as a critically important core for trials in kidney transplantation. We aimed to validate a patient-reported outcome measure for life participation in kidney transplant recipients.MethodsA psychometric evaluation of the Standardized Outcomes in Nephrology life participation (SONG-LP) measure was conducted in adult kidney transplant recipients. The measure includes 4 items of life participation (leisure, family, work, and social) each with a 5-point Likert scale. Each item is scored from 0 (never) to 4 (always) and the summary measure score the average of each item.ResultsA total of 249 adult kidney transplant recipients from 20 countries participated. The SONG-LP instrument demonstrated internal consistency (Cronbach’s α = 0.87; 95% confidence intervals [CI]: 0.83–0.90, baseline) and test-retest reliability over 1 week (intraclass correlation coefficient of 0.62; 95% CI: 0.54–0.70). There was moderate to high correlation (0.65; 95% CI: 0.57–0.72) with the PROMIS Ability to Participate in Social Roles and Activities Short Form 8a that assessed a similar construct, and moderate correlation with measures that assessed related concepts (i.e., EQ5D 0.57; 95% CI: 0.49–0.65), PROMIS Cognitive Functional Abilities Subset Short Form 4a (0.40; 95% CI: 0.29–0.50).ConclusionThe SONG-LP instrument is a simple, internally consistent, reliable measure for kidney transplant recipients and correlates with similar measures. Routine incorporation in clinical trials will ensure consistent and appropriate assessment of life participation for informed patient-centered decision-making.<br/

The Impact of the COVID-19 Pandemic on Patients With CKD: Systematic Review of Qualitative Studies

Rationale &amp; Objective: COVID-19 disproportionately affects people with co-morbidities, including chronic kidney disease (CKD). The aim of this study was to describe the impact of COVID-19 on people with CKD and their caregivers. Study Design: A systematic review of qualitative studies. Setting &amp; Study Populations: Primary studies that reported the experiences and perspectives of adults with CKD and/or caregivers were eligible. Search Strategy &amp; Sources: MEDLINE, Embase, PsycINFO, CINAHL were searched from database inception to October 2022. Data Extraction: Two authors independently screened the search results. Full texts of potentially relevant studies were assessed for eligibility. Any discrepancies were resolved by discussion with another author. Analytical Approach: A thematic synthesis was used to analyze the data. Results: Thirty-four studies involving 1962 participants were included. Four themes were identified: exacerbating vulnerability and distress (looming threat of COVID-19 infection, intensifying isolation, aggravating pressure on families); uncertainty in accessing health care (overwhelmed by disruption of care, confused by lack of reliable information, challenged by adapting to telehealth, skeptical about vaccine efficacy and safety); coping with self-management (waning fitness due to decreasing physical activity, diminishing ability to manage diet, difficulty managing fluid restrictions, minimized burden with telehealth, motivating confidence and autonomy); and strengthening sense of safety and support (protection from lockdown restrictions, increasing trust in care, strengthened family connection). Limitations: Non-English studies were excluded and the inability to delineate themes based on stage of kidney and treatment modality. Conclusions: Uncertainty in accessing health care during the COVID-19 pandemic exacerbated vulnerability, emotional distress, and burden, and led to reduced capacity to self-manage among patients with CKD and their caregivers. Optimizing telehealth and access to educational and psychosocial support may improve self-management, and the quality and effectiveness of care during a pandemic, mitigating potentially catastrophic consequences in people with CKD. Registration: Study not registered

糖尿病患者接受连续血糖监测和传感器增强胰岛素泵治疗的体验:对定性研究的系统综述

Abstract Aims Blood glucose control is central to the management of diabetes, and continuous glucose monitoring (CGM) improves glycemic control. We aimed to describe the perspectives of people with diabetes using CGM. Materials and methods We performed a systematic review of qualitative studies. Results Fifty‐four studies involving 1845 participants were included. Six themes were identified: gaining control and convenience (reducing pain and time, safeguarding against complications, achieving stricter glucose levels, and sharing responsibility with family); motivating self‐management (fostering ownership, and increasing awareness of glycemic control); providing reassurance and freedom (attaining peace of mind, and restoring social participation); developing confidence (encouraged by the endorsement of others, gaining operational skills, customizing settings for ease of use, and trust in the device); burdened with device complexities (bewildered by unfamiliar technology, reluctant to rely on algorithms, overwhelmed by data, frustrated with malfunctioning and inaccuracy, distressed by alerts, and bulkiness of machines interfering with lifestyle); and excluded by barriers to access (constrained by cost, lack of suppliers). Conclusions CGM can improve self‐management and confidence in patients managing diabetes. However, the technical issues, uncertainty in readings, and cost may limit the uptake. Education and training from the health professionals may help to reduce the practical and psychological burden for better patient outcomes

Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease

BackgroundAnaemia occurs in chronic kidney disease (CKD) and is more prevalent with lower levels of kidney function. Anaemia in CKD is associated with death related to cardiovascular (CV) disease and infection. Established treatments include erythropoiesis-stimulating agents (ESAs), iron supplementation and blood transfusions. Oral hypoxia-inducible factors (HIF) stabilisers are now available to manage anaemia in people with CKD.ObjectivesWe aimed to assess the benefits and potential harms of HIF stabilisers for the management of anaemia in people with CKD.Search methodsWe searched the Cochrane Kidney and Transplant Register of Studies up to 22 November 2021 through contact with the Information Specialist using search terms relevant to our 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 criteriaRandomised and quasi-randomised studies evaluating hypoxia-inducible factors stabilisers compared to placebo, standard care, ESAs or iron supplementation in people with CKD were included.Data collection and analysisFive authors independently extracted data and assessed the risk of bias. Treatment estimates were summarised using random effects pair-wise meta-analysis and expressed as a relative risk (RR) or mean difference (MD), with a corresponding 95% confidence interval (CI). Evidence certainty was assessed using GRADE.Main resultsWe included 51 studies randomising 30,994 adults. These studies compared HIF stabilisers to either placebo or an ESA.Compared to placebo, HIF stabiliser therapy had uncertain effects on CV death (10 studies, 1114 participants): RR 3.68, 95% CI 0.19 to 70.21; very low certainty evidence), and nonfatal myocardial infarction (MI) (3 studies, 822 participants): RR 1.29, 95% CI 0.31 to 5.36; I-2 = 0%; very low certainty evidence), probably decreases the proportion of patients requiring blood transfusion (8 studies, 4329 participants): RR 0.51, 95% CI 0.44 to 0.60; I-2 = 0%; moderate certainty evidence), and increases the proportion of patients reaching the target haemoglobin (Hb) (10 studies, 5102 participants): RR 8.36, 95% CI 6.42 to 10.89; I-2 = 37%; moderate certainty evidence).Compared to ESAs, HIF stabiliser therapy may make little or no difference to CV death (17 studies, 10,340 participants): RR 1.05, 95% CI 0.88 to 1.26; I-2 = 0%; low certainty evidence), nonfatal MI (7 studies, 7765 participants): RR 0.91, 95% CI 0.76 to 1.10; I-2 = 0%; low certainty evidence), and nonfatal stroke (5 studies, 7285 participants): RR 1.06, 95% CI 0.71 to 1.56; I-2 = 8%; low certainty evidence), and had uncertain effects on fatigue (2 studies, 3471 participants): RR 0.80, 95% CI 0.56 to 1.16; I-2 = 0%; very low certainty evidence). HIF stabiliser therapy probably decreased the proportion of patients requiring blood transfusion (11 studies, 10,786 participants): RR 0.87, 95% CI 0.76 to 1.00; I-2 = 25%; moderate certainty evidence), but may make little or no diIerence on the proportion of patients reaching the target Hb (14 studies, 4601 participants): RR 1.00, 95% CI 0.93 to 1.07; I-2 = 70%; low certainty evidence), compared to ESA.The effect of HIF stabilisers on hospitalisation for heart failure, peripheral arterial events, loss of unassisted dialysis vascular access patency, access intervention, cancer, infection, pulmonary hypertension and diabetic nephropathy was uncertain.None of the included studies reported life participation. Adverse events were rarely and inconsistently reported.Authors' conclusionsHIF stabiliser management of anaemia had uncertain effects on CV death, fatigue, death (any cause), CV outcomes, and kidney failure compared to placebo or ESAs. Compared to placebo or ESAs, HIF stabiliser management of anaemia probably decreased the proportion of patients requiring blood transfusions, and probably increased the proportion of patients reaching the target Hb when compared to placebo

[In Press] Indigenous Peoples' perspectives of living with chronic kidney disease: systematic review of qualitative studies

Marianne Kerr, Nicole Evangelidis, Penelope Abbott, Jonathan C. Craig, Michelle Dickson, Nicole Scholes-Robertson, Victoria Sinka, Rahim T. Vastani, Katherine Widders, Jacqueline H. Stephens, and Allison Jaur

Supplemental Material, sj-docx-1-ptd-10.1177_08968608221126849 - Range and consistency of gastrointestinal outcomes reported in peritoneal dialysis trials: A systematic review

Supplemental Material, sj-docx-1-ptd-10.1177_08968608221126849 for Range and consistency of gastrointestinal outcomes reported in peritoneal dialysis trials: A systematic review by Ashik Hayat, Rachael C Walker, Andrea K Viecelli, Karine E Manera, Allison Jaure, Rathika Krishnasamy, Elaine M Pascoe, Yeoungjee Cho and David W Johnson in Peritoneal Dialysis International</p

The Point-of-Care Peritoneal Dialysis System Early Evaluation Study (POC-PDEE): A pilot proof-of-principal study of the Ellen Medical Devices Point-of-Care affordable peritoneal dialysis system.

The global unmet need for kidney replacement therapy means that millions of people die every year as they cannot afford treatment. Peritoneal dialysis (PD) offers comparable survival to haemodialysis and is often more affordable, but one barrier to increasing access is that conventional manufacturing and distribution of PD fluid is costly. Here we report the results from a pilot proof-of-principal study demonstrating for the first time that the Ellen Medical Devices Point-of-Care system can be used by patients to produce sterile PD fluid at the point-of-care. With further development, this low-cost system could offer a solution to the many millions of people around the world who currently cannot afford treatment for kidney failure