Effect of a coaching intervention to enhance physical activity and prevent falls in community-dwelling people aged 60+ years: a cluster randomised controlled trial.

OBJECTIVES: To evaluate the effect of a coaching intervention compared with control on physical activity and falls rate at 12 months in community-dwelling people aged 60+ years. DESIGN: Cluster randomised controlled trial. SETTING: Community-dwelling older people. PARTICIPANTS: 72 clusters (605 participants): 37 clusters (290 participants) randomised to the intervention and 35 (315 participants) to control. INTERVENTION: Intervention group received written information, fall risk assessment and prevention advice by a physiotherapist, activity tracker and telephone-based coaching from a physiotherapist focused on safe physical activity. Control group received written information and telephone-based dietary coaching. Both groups received up to 19 sessions of telephone coaching over 12 months. OUTCOMES: The co-primary outcomes were device-measured physical activity expressed in counts per minute at 12 months and falls rate over 12 months. Secondary outcomes included the proportion of fallers, device-measured daily steps and moderate-to-vigorous physical activity (MVPA), self-reported hours per week of physical activity, body mass index, eating habits, goal attainment, mobility-related confidence, quality of life, fear of falling, risk-taking behaviour, mood, well-being and disability. RESULTS: The mean age of participants was 74 (SD 8) years, and 70% (n=425) were women. There was no significant effect of the intervention on device-measured physical activity counts per minute (mean difference 5 counts/min/day, 95% CI -21 to 31), or falls at 12 months (0.71 falls/person/year in intervention group and 0.87 falls/person/year in control group; incidence rate ratio 0.86, 95% CI 0.65 to 1.14). The intervention had a positive significant effect on device-measured daily steps and MVPA, and self-reported hours per week of walking, well-being, quality of life, and disability. No significant between-group differences were identified in other secondary outcomes. CONCLUSION: A physical activity and fall prevention programme including fall risk assessment and prevention advice, plus telephone-based health coaching, did not lead to significant differences in physical activity counts per minute or falls rate at 12 months. However, this programme improved other physical activity measures (ie, daily steps, MVPA, hours per week of walking), overall well-being, quality of life and disability. TRIAL REGISTRATION NUMBER: ACTRN12615001190594.

Financial toxicity experienced by rural Australian families with chronic kidney disease.

AIM: Chronic kidney disease (CKD) and its treatment places a financial burden on healthcare systems and households worldwide, yet little is known of its financial impact, on those who reside in rural settings. We aimed to quantify the financial impacts and out-of-pocket expenditure experienced by adult rural patients with CKD in Australia. METHODS: A web based structured survey was completed between November 2020 and January 2021. English speaking participants over 18 years of age, diagnosed with CKD stages 3-5, those receiving dialysis or with a kidney transplant, who lived in a rural location in Australia. RESULTS: In total 77 (69% completion rate) participated. The mean out of pocket expenses were 5056 AUD annually (excluding private health insurance costs), 78% of households experienced financial hardship with 54% classified as experiencing financial catastrophe (out-of-pocket expenditure greater than 10% of household income). Mean distances to access health services for all rural and remote classifications was greater than 50 kilometres for specialist nephrology services and greater than 300 kilometres for transplanting centres. Relocation for a period greater than 3 months to access care was experienced by 24% of participants. CONCLUSION: Rural households experience considerable financial hardship due to out-of-pocket costs in accessing treatment for CKD and other health-related care, raising concerns about equity in Australia, a high-income country with universal healthcare.

Patients' Perspectives, Factors, and Patterns of eHealth Use in Kidney Transplant Recipients.

Introduction: eHealth supports the delivery of relevant health information and management of chronic disease. However, little is known about patients' perspectives and the determinants of eHealth use among kidney transplant recipients. Methods: Kidney transplant recipients aged 18 years and older from 3 transplant units in Australia and the Better Evidence and Translation in Chronic Kidney Disease consumer network completed a survey with free-text responses relating to eHealth uptake. Multivariable regression modeling was used to determine the factors associated with eHealth use. Free-text responses were thematically analyzed. Results: Of the 117 participants who were invited in person and who responded to the email, 91 completed the survey. Sixty-three participants (69%) were current eHealth users (active use of eHealth tools), and 91% had access to eHealth devices, including smartphones (81%) and computers (59%). Most (98%) reported that eHealth improves posttransplant care. Factors associated with increased eHealth use (odds ratio [95% confidence interval]) were higher eHealth literacy scale (eHEALS) score (1.21 [1.06-1.38]) and tertiary education (7.78 [2.19-27.7]). We identified the following 3 themes on eHealth determinants: (i) empowering self-management, (ii) enhancing health services, and (iii) technology burden. Conclusions: Transplant recipients believe that eHealth interventions have the potential to improve their posttransplant care. eHealth interventions should meet the needs of all transplant recipients and be accessible to those with lower educational attainment.

Scope and Consistency of Cancer Outcomes Reported in Randomized Trials in Kidney Transplant Recipients.

Introduction: Cancer is an important outcome in kidney transplantation, but the scope and consistency of how cancer is defined and reported in trials involving kidney transplant recipients has not been evaluated. This study aimed to assess the range and variability of cancer outcomes in trials involving kidney transplant recipients. Methods: The ClinicalTrials.gov database was searched from February 2000 to July 2021 to identify all randomized controlled trials (RCTs) in adult kidney transplant recipients, and which included cancer as a specified outcome. The definition of cancer, types of cancer (if any), timepoint(s) of measurement and method of aggregation were extracted for each cancer outcome. Results: Of the 819 trials in kidney transplantation, only 84 (10%) included 1 or more cancer outcomes. Of these, 72 of 84 (86%) trials included cancer as a secondary outcome and 12 of 84 (14%) considered cancer as a primary outcome. The most frequent description of cancer was "malignancy" (n = 44, 43%), without reference to diagnostic criteria, histology, grade, or stage. The 2 most common cancer types were posttransplant lymphoproliferative disorder (PTLD) (n = 20, 20%) and nonmelanoma skin cancer (n = 10, 10%). Several methods of aggregation were identified, including incidence or rate (n = 47, 46%), frequency or proportion (n = 30, 29%), and time to event (n = 5, 5%). Approximately half the cancer outcomes were measured at a single time point (n = 44, 52%). Conclusion: Cancer is an infrequently reported outcome and is inconsistently defined in trials of kidney transplant recipients. Consistent reporting of cancer outcomes using standardized definitions would provide important information on the impact of cancer in patients after kidney transplantation.

Child and caregiver perspectives on access to psychosocial and educational support in pediatric chronic kidney disease: a focus group study.

BACKGROUND: Children with chronic kidney disease (CKD) generally have worse educational and psychosocial outcomes compared with their healthy peers. This can impair their ability to manage their treatment, which in turn can have long-term health consequences through to adulthood. We attempted to capture the experiences of children with CKD and to describe the perspectives of their parents and caregivers on access to educational and psychosocial support. METHODS: Children with CKD (n = 34) and their caregivers (n = 62) were sampled via focus groups from pediatric hospitals in Australia, Canada, and the USA. Sixteen focus groups were convened and the transcripts were analyzed thematically. RESULTS: We identified four themes: disruption to self-esteem and identity (emotional turmoil of adolescence, wrestling with the sick self, powerlessness to alleviate child's suffering, balancing normality and protection); disadvantaged by lack of empathy and acceptance (alienated by ignorance, bearing the burden alone); a hidden and inaccessible support system (excluded from formal psychological support, falling behind due to being denied special considerations); and building resilience (finding partners in the journey, moving towards acceptance of the illness, re-establishing childhood). CONCLUSIONS: Children with CKD and their caregivers encountered many barriers in accessing psychosocial and educational support and felt extremely disempowered and isolated as a consequence. Improved availability and access to psychosocial and educational interventions are needed to improve the wellbeing and educational advancement of children with CKD. A higher resolution version of the Graphical abstract is available as Supplementary information.

Engagement and fidelity of a cardiovascular disease prevention-focused digital health intervention in cardiology outpatient waiting rooms: a mixed-methods study.

INTRODUCTION: We delivered a video-based, cardiovascular disease prevention focused intervention in cardiology waiting rooms that increased motivation to improve cardiovascular risk behaviours and satisfaction with clinic services. To better understand the potential generalisability and scalability of such waiting room interventions, this study evaluated the fidelity of intervention delivery and barriers and enablers to implementation. METHODS: Mixed-methods process evaluation conducted among intervention participants in a randomised clinical trial. Data sources included (1) Participant screening logs, (2) Intervention delivery platform data and (3) Semi structured interviews performed with participants. Qualitative data were described using inductive thematic analysis. RESULTS: The tablet-based intervention was delivered to 220 patients (112 (50.9%) male, mean age 54.2 (SD 15.4) years). Of 765 videos opened, 636 (83.1%) were watched to completion. Most videos opened were rated (738/765, 96.5%) and video ratings were predominantly positive (661/738, (89.6%) satisfied or highly satisfied). Younger and more educated participants were more likely to rate videos highly (relative risk (RR) 1.73 (95% CI 1.28 to 2.32) and RR 1.26 (95% CI 1.07 to 1.49)) but less likely to watch videos to completion (younger: RR 0.27 (95% CI 0.17 to 0.43), more educated: RR 0.90 (95% CI 0.85 to 0.96)). Of 39 invited, 21 (53.8%) participated in semistructured interviews. Thematic analysis of responses suggested reported behaviour change post intervention may be due to increased awareness of cardiovascular risk, reduced anxiety and intrinsic motivation from delivery within a cardiology waiting room. Lack of reinforcement and limited personalisation were barriers. CONCLUSION: The current analysis demonstrates that engagement with a digitally delivered clinic waiting room educational intervention was high, providing explanation for its efficacy in improving motivation to change cardiovascular risk behaviours. The high fidelity of delivery demonstrates potential for scaling of such interventions across waiting rooms. Recall bias and low response rate may bias self-reported engagement measures. TRIAL REGISTRATION NUMBER: ANZCTR12618001725257.

Range and Consistency of Cardiovascular Outcomes Reported by Clinical Trials in Kidney Transplant Recipients: A Systematic Review.

Cardiovascular disease is a major cause of morbidity and mortality in kidney transplant recipients. Trial evidence to improve cardiovascular outcomes is limited by inconsistent reporting of outcomes, which may also lack patient-relevance. This study aimed to assess the range and consistency of cardiovascular outcomes reported by contemporary trials in kidney transplant recipients. Methods: A systematic review of all randomized controlled trials involving adult kidney transplant recipients that reported at least 1 cardiovascular outcome from January 2012 to December 2019 was performed, including Embase, MEDLINE, Cochrane, and ClinicalTrials.gov electronic databases. Trial characteristics were extracted and all levels of specification of the cardiovascular outcome measures reported were analyzed (the measure definition, metric' and method of aggregation). Measures assessing a similar aspect of cardiovascular disease were categorized into outcomes. Results: From 93 eligible trials involving 27 609 participants, 490 outcome measures were identified. The outcome measures were grouped into 38 outcomes. A cardiovascular composite was the most common outcome reported (40 trials, 43%) followed by cardiovascular mortality (42%) and acute coronary syndrome (31%). Cardiovascular composite was also the most heterogeneous outcome with 77 measures reported followed by cardiovascular mortality (n = 58) and inflammatory biomarkers (n = 51). The most common cardiovascular composite outcome components reported were major cardiovascular events (18 trials), stroke unspecified (11 trials), and myocardial infarction unspecified (10 trials). Conclusions: There is substantial heterogeneity in cardiovascular outcome reporting in kidney transplant trials.

Sources of Clinician Burnout in Providing Care for Underserved Patients in a Safety-Net Healthcare System.

BACKGROUND: Burnout among clinicians is common and can undermine quality of care, patient outcomes, and workforce preservation, but sources of burnout or protective factors unique to clinicians working in safety-net settings are less well understood. Understanding these clinician experiences may inform interventions to reduce burnout. OBJECTIVE: To describe clinician perspectives on sources of burnout in a safety-net healthcare system. DESIGN: Semi-structured interviews were conducted with clinicians from multiple disciplines who provided care at a safety-net healthcare system from October 2018 to January 2019. Transcripts were analyzed using thematic analysis. PARTICIPANTS: Forty clinicians (25 female and 15 male; mean [SD] age, 41 [9.1]) participated, including physicians, social workers, advanced practice providers, nurses, psychologists, physical and occupational therapists, and other healthcare professionals. MAIN OUTCOMES AND MEASURES: Themes and subthemes that reflected clinician experiences, burnout, and workload expectations. KEY RESULTS: Five themes emerged: limited resources (entrenched social injustices, brokenness of the US healthcare system, precarious discharge options, and "revolving door" readmissions), barriers to building trust with patients (chasm of communication, addressing fear and mistrust, and being exposed to threats), administrative requirements (criticism hampering meaningful care, assuming extra workloads, bureaucratic burden), compassion fatigue (confronting traumatic situations, persistent worry about patient safety and welfare, witnessing mistreatment and stigmatization, overextending and overinvesting, withdrawing and shutting down, blaming self and career crisis), and advocacy as a counterbalance to burnout (solidarity when helping underserved communities, fervent advocacy, and patient gratitude). CONCLUSIONS: Among clinicians who provide care in a safety-net healthcare system, sources of burnout included limited resources, barriers to building trust with patients, administrative requirements, and compassion fatigue, but clinicians remained driven by their desire to advocate for patients. Policy-level interventions which increase funding to safety-net healthcare systems to bolster existing resources and staffing, create peer-support and wellness programs, and support advocacy efforts may mitigate burnout.

Perspectives of Kidney Transplant Recipients on eHealth: Semistructured Interviews.

The acceptability and impact of eHealth on patient outcomes may be limited if their concerns and priorities are not addressed. This study aimed to describe the perspectives and experiences of eHealth among kidney transplant recipients. Methods: Face-to-face semistructured interviews were conducted with 30 adult kidney transplant recipients from New South Wales, Australia (urban and regional), in ambulatory clinics. We used purposive sampling to obtain a wide range of demographic and clinical characteristics. Transcripts were analyzed thematically. Ethics was approved by the Western Sydney Local Health District (6054-2019/ETH08718). Findings: Six themes were identified: seeking access to quality care (prioritizing and trusting clinician advice, better safety and timeliness, enabled by user-friendly content); supporting self-management (responsive to individualized informational need, empowerment through practical knowledge, encouraging connectedness); assessing reliability and trustworthiness (discerning information integrity, applying to own context, apprehensive about privacy and confidentiality); enhancing health system capabilities (synergy with routine consultations, essential to coordination, achieving goals by real-time monitoring); technology burden and limitation (uncertainty with navigation and comprehension, challenged by technical difficulties, requiring additional preparation, confrontation and distress); and lacking applicable value (diminished assurance of medical services, existing practice and procedures, hampered by low expectations and disinterest). Conclusion: Recipients felt eHealth could support healthcare delivery and self-management activities. However, they encountered challenges in navigating technology and were concerned about privacy, confidentiality, and misinformation. eHealth that is accessible, individualized, and secure may improve patient satisfaction and outcomes.

Experiences and challenges faced by patients with COVID-19 who were hospitalised and participated in a randomised controlled trial: a qualitative study.

OBJECTIVES: As part of a randomised controlled trial, this qualitative study aimed to identify experiences and challenges of hospitalised patients with COVID-19 during illness and treatment (objective 1: COVID-19-related perspectives; objective 2: trial participation-related perspectives). DESIGN: Semistructured interviews following a prespecified interview guide, transcribed verbatim and analysed in accordance with the grounded theory process. Investigator triangulation served to ensure rigour of the analysis. SETTING: Interviews were embedded in a multicentre, randomised, active-controlled, open-label platform trial testing efficacy and safety of experimental therapeutics for patients with COVID-19 (Austrian Corona Virus Adaptive Clinical Trial). PARTICIPANTS: 20 patients (60±15 years) providing 21 interviews from 8 June 2020 to 25 April 2021. RESULTS: Qualitative data analysis revealed four central themes with subthemes. Theme 1, 'A Severe Disease', related to objective 1, was characterised by subthemes 'symptom burden', 'unpredictability of the disease course', 'fear of death' and 'long-term aftermaths with lifestyle consequences'. Theme 2, 'Saved and Burdened by Hospitalization', related to objective 1, comprised patients describing their in-hospital experience as 'safe haven' versus 'place of fear', highlighting the influence of 'isolation'. Theme 3, 'Managing One's Own Health', related to objective 1, showed how patients relied on 'self-management' and 'coping' strategies. Theme 4, 'Belief in Medical Research', related to objective 2, captured patients' 'motivation for study participation', many expressing 'information gaps' and 'situational helplessness' in response to study inclusion, while fewer mentioned 'therapy side-effects' and provided 'study reflection'. Investigator triangulation with an expert focus group of three doctors who worked at the study centre confirmed the plausibility of these results. CONCLUSIONS: Several of the identified themes (2, 3, 4) are modifiable and open for interventions to improve care of patients with COVID-19. Patient-specific communication and information is of utmost importance during clinical trial participation, and was criticised by participants of the present study. Disease self-management should be actively encouraged. TRIAL REGISTRATION NUMBER: NCT04351724.

Protocol for establishing a core outcome set for evaluation in studies of pulmonary exacerbations in people with cystic fibrosis.

INTRODUCTION: Pulmonary exacerbations are associated with increased morbidity and mortality in people with cystic fibrosis (CF). There is no consensus about which outcomes should be evaluated in studies of pulmonary exacerbations or how these outcomes should be measured. Outcomes of importance to people with lived experience of the disease are frequently omitted or inconsistently reported in studies, which limits the value of such studies for informing practice and policy. To better standardise outcome reporting and measurement, we aim to develop a core outcome set for studies of pulmonary exacerbations in people with CF (COS-PEX) and consensus recommendations for measurement of core outcomes. METHODS AND ANALYSIS: Preliminary work for development of COS-PEX has been reported, including (1) systematic reviews of outcomes and methods for measurement reported in existing studies of pulmonary exacerbations; (2) workshops with people affected by CF within Australia; and (3) a Bayesian knowledge expert elicitation workshop with health professionals to ascertain outcomes of importance. Here we describe a protocol for the additional stages required for COS-PEX development and consensus methods for measurement of core outcomes. These include (1) an international two-round online Delphi survey and (2) consensus workshops to review and endorse the proposed COS-PEX and to agree with methods for measurement. ETHICS AND DISSEMINATION: National mutual ethics scheme approval has been provided by the Child and Adolescent Health Service Human Research Ethics Committee (RGS 4926). Results will be disseminated via consumer and research networks and peer-reviewed publications. This study is registered with the Core Outcome Measures in Effectiveness Trials database.

NAVKIDS2 trial: a multi-centre, waitlisted randomised controlled trial of a patient navigator intervention in children with chronic kidney disease - statistical analysis plan and update to the protocol.

BACKGROUND: This update summarises key changes made to the protocol since the publication of the original protocol for the NAVKIDS2 trial of patient navigators for children with chronic kidney disease (CKD) experiencing social disadvantage and provides the statistical analysis plan (SAP) which has not previously been published. METHODS/DESIGN: The original protocol was published in BMC Nephrology ( https://doi.org/10.1186/s12882-019-1325-y ) prior to the commencement of trial recruitment. During the course of the trial, some key methodological changes needed to be made including changes to eligibility criteria (addition of patients with CKD stages 1-2, broadening of financial status eligibility criterion, addition of patients living in rural/remote areas, modification of age eligibility to 0-16 years, addition of limits related to the language spoken by family, guidance regarding families with multiple eligible children), changes to sites, reduction of sample size, addition of virtual options for consent and study procedures in response to the COVID-19 pandemic, removal of staggered recruitment across sites, addition of outcomes, and changes to the timing and number of assessments. This update summarises the changes made and their rationale and provides the detailed plan for statistical analysis of the trial. These changes have been finalised prior to the completion of study follow-up and the commencement of data analysis. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618001152213 . Prospectively registered on 12 July 2018.

Perspectives of a proposed patient navigator programme for people with chronic kidney disease in rural communities: Report from national workshops.

AIMS: People who live in rural areas have reduced access to appropriate and timely healthcare, leading to poorer health outcomes than their metropolitan-based counterparts. The aims of the workshops were to ascertain participants' perspectives on barriers to access to dialysis and transplantation, to identify and prioritize the roles of a rural patient navigator, to discuss the acceptability and feasibility of implementing this role and identify possible outcomes that could be used to measure the success of the programme in a clinical trial. METHODS: Rural patients (n = 19), their caregivers (n = 5) and health professionals (n = 18) from Australia participated in three workshops. We analysed the data using thematic analysis. RESULTS: We identified four themes related to access to dialysis and transplantation: overwhelmed by separate and disconnected health systems, unprepared for emotional toll and isolation, lack of practical support and inability to develop trust and rapport. Four themes related to the role of the patient navigator programme: valuing lived experience, offering cultural expertise, requiring a conduit, and flexibility of the job description. The key roles prioritized by participants were psychological support and networking, provision/consolidation of education, and provision of practical support. CONCLUSION: Rural patients, caregivers and health professionals believed that programmes that include navigators with lived experience of dialysis and kidney transplantation and cultural expertise, especially for Aboriginal Australians, may have the potential to improve patient experiences in accessing healthcare.

An eHealth self-management intervention for adults with chronic kidney disease, My Kidneys My Health: a mixed-methods study.

BACKGROUND: There is limited research of electronic tools for self-management for patients with chronic kidney disease (CKD). We sought to evaluate participant engagement, perceived self-efficacy and website usage in a preliminary evaluation of My Kidneys My Health, a patient-facing eHealth tool in Canada. METHODS: We conducted an explanatory sequential mixed-methods study of adults with CKD who were not on kidney replacement therapy and who had access to My Kidneys My Health for 8 weeks. Outcomes included acceptance (measured by the Technology Acceptance Model), self-efficacy (measured by the Chronic Disease Self-Efficacy Scale [CDSES]) and website usage patterns (captured using Google Analytics). We analyzed participant interviews using qualitative content analysis. RESULTS: Twenty-nine participants with CKD completed baseline questionnaires, of whom 22 completed end-of-study questionnaires; data saturation was achieved with 15 telephone interviews. Acceptance was high, with more than 70% of participants agreeing or strongly agreeing that the website was easy to use and useful. Of the 22 who completed end-of-study questionnaires, 18 (82%) indicated they would recommend its use to others and 16 (73%) stated they would use the website in the future. Average scores for website satisfaction and look and feel were 7.7 (standard deviation [SD] 2.0) and 8.2 (SD 2.0) out of 10, respectively. The CDSES indicated that participants gained an increase in CKD information. Interviewed participants reported that the website offered valuable information and interactive tools for patients with early or newly diagnosed CKD, or for those experiencing changes in health status. Popular website pages and interactive features included Food and Diet, What is CKD, My Question List and the Depression Screener. INTERPRETATION: Participants indicated that the My Kidneys My Health website provided accessible content and tools that may improve self-efficacy and support in CKD self-management. Further evaluation of the website's effectiveness in supporting self-management among a larger, more heterogenous population is warranted.

Establishing a Core Outcome Measure for Peritoneal Dialysis-related Peritonitis: A Standardized Outcomes in Nephrology-Peritoneal Dialysis Consensus Workshop Report.

Introduction: Peritoneal dialysis (PD)-related peritonitis is one of the leading causes of discontinuation of PD and is considered a critically important outcome for patients on PD. However, there is no universally accepted method of measuring this outcome in clinical trials. Methods: We convened an online consensus workshop to establish a core outcome measure for PD-related peritonitis in clinical trials. Results: A total of 53 participants, including 18 patients and caregivers, from 12 countries engaged in breakout discussions in this workshop. Transcripts were analyzed thematically. We identified the following 3 themes: (i) feasibility and applicability across diverse settings, which reflected the difficulty with implementing laboratory-based measures in resource-limited environments; (ii) ensuring validity, which included minimizing false positives and considering the specificity of symptoms; and (iii) being meaningful and tangible to patients, which meant that the measure should be easy to interpret, reflect the impact that symptoms have on patients, and promote transparency by standardizing the reporting of peritonitis among dialysis units. Conclusion: A core outcome measure for PD-related peritonitis should include both symptom-based and laboratory-based criteria. Thus, the International Society for Peritoneal Dialysis (ISPD) definition of peritonitis is acceptable. However, there should be consideration of reporting suspected peritonitis in cases where laboratory confirmation is not possible. The measure should include all infections from the time of catheter insertion and capture both the rate of infection and the number of patients who remain peritonitis free. A core outcome measure with these features would increase the impact of clinical trials on the care and decision-making of patients receiving PD.

Under-screened Aboriginal and Torres Strait Islander women's perspectives on cervical screening.

Aboriginal and Torres Strait Islander women have lower participation in Australia's National Cervical Screening Program than other Australian women. Under-screened (including never screened) women's voices are rarely heard in research evidence, despite being a priority group for interventions to increase cervical screening participation. This study aimed to describe under-screened Aboriginal and Torres Strait Islander women's perspectives on cervical screening. Participants were 29 under-screened (women who had either never screened, had not screened in the previous five years or had recently screened in the past three months after more than five years) Aboriginal and Torres Strait Islander women from five communities across three states/territories. Female Aboriginal and Torres Strait Islander researchers Yarned with women about why they did not participate in screening and how to improve screening. Yarning is an Indigenous qualitative research method in which relationships and trust facilitate culturally safe conversation. Transcripts were analysed thematically. The proportion of eligible women who screened within 30 days after the Yarn was calculated. We identified four themes describing how the harms outweighed the benefits of cervical screening for under-screened women. These were: 1) distress, discomfort, and trauma; 2) lack of privacy and control; 3) complicated relationships with health care providers (HCPs); and 4) pressured, insensitive, and/or culturally unsafe communication from HCPs. Under-screened women who had recently screened had maintained privacy and control through self-collection and had experienced trauma-informed and empathetic care from their HCPs. While we cannot unequivocally attribute women's subsequent participation in screening to their involvement in this study, it is notable that one third of eligible under-screened women were screened within 30 days after the Yarn. Enhancing privacy, implementing trauma-informed approaches to care and sensitivity to the clinician-client relationship dynamics could enhance women's sense of comfort in, and control over, the screening procedure. The opportunity to Yarn about cervical screening and self-collection may address these issues and support progress toward cervical cancer elimination in Australia.

The critical role of mixed methods research in developing valid and reliable patient-reported outcome measures.

Randomised controlled clinical trials provide the gold standard for evidence underpinning clinical guidelines and patient centred care. However, this is only true when they are robustly designed, conducted and reported and then only if they include outcomes that are important to patients and clinicians. Important outcomes include those that measure impact on patient experience, quality of life, overall well-being, and physical, social, cognitive and emotional functioning, all of which require patient reported outcome measures (PROMs). Patient centred care must be underpinned by objective evidence of the effect of interventions on outcomes that are important to patients. Evidence for patient reported outcomes must be supported by valid and reliable PROMs. Importantly the PROM must reflect patient experience of the impact of the intervention on the outcome and enable quantitative evaluation of that impact. The purpose of this paper is to highlight the critical role of mixed methods research in developing PROMs that are valid (measure what they purport to measure), acceptable to those reporting the outcome and able to reliably detect meaningful differences between individuals with different conditions or severity and with time. This can only be achieved through a structured mixed methods program combining qualitative and quantitative research techniques.

Patient-centred clinical trial design.

Patient involvement in clinical trial design can facilitate the recruitment and retention of participants as well as potentially increase the uptake of the tested intervention and the impact of the findings on patient outcomes. Despite these benefits, patients still have very limited involvement in designing and conducting trials in nephrology. Many trials do not address research questions and outcomes that are important to patients, including patient-reported outcomes that reflect how patients feel and function. This limitation can undermine the relevance, reliability and value of trial-based evidence for decision-making in clinical practice and health policy. However, efforts to involve patients with kidney disease are increasing across all stages of the trial process from priority setting, to study design (including selection of outcomes and approaches to improve participant recruitment and retention) and dissemination and implementation of the findings. Harnessing the patient voice in designing trials can ensure that efforts and resources are directed towards patient-centred trials that address the needs, concerns and priorities of patients living with kidney disease with the aim of achieving transformative improvements in care and outcomes.

Patient-Reported Outcomes as Endpoints in Clinical Trials of Kidney Transplantation Interventions.

Patient-reported outcomes (PROs) that assess individuals' perceptions of life participation, medication adherence, disease symptoms, and therapy side effects are extremely relevant in the context of kidney transplantation. All PROs are potentially suitable as primary or secondary endpoints in interventional trials that aim to improve outcomes for transplant recipients. Using PRO measures (PROMs) in clinical trials facilitates assessment of the patient's perspective of their health, but few measures have been developed and evaluated in kidney transplant recipients; robust methodologies, which use validated instruments and established frameworks for reporting, are essential. Establishing a core PROM for life participation in kidney transplant recipients is a critically important need, which is being developed and validated by the Standardized Outcomes in Nephrology (SONG)-Tx Initiative. Measures involving electronic medication packaging and smart technologies are gaining traction for monitoring adherence, and could provide more robust information than questionnaires, interviews, and scales. This article summarizes information on PROs and PROMs that was included in a Broad Scientific Advice request on clinical trial design and endpoints in kidney transplantation. This request was submitted to the European Medicines Agency (EMA) by the European Society for Organ Transplantation in 2016. Following modifications, the EMA provided its recommendations in late 2020.