Peritoneal Dialysis Catheter Complications after Insertion by Surgeons, Radiologists, or Nephrologists.

SIGNIFICANCE STATEMENT: The Advancing American Kidney Health Initiative aims to increase rates of utilization of peritoneal dialysis (PD) in the United States. One of the first steps to PD is successful catheter placement, which can be performed by surgeons, interventional radiologists, or nephrologists. We examined the association between operator subspecialty and risk of needing a follow-up procedure in the first 90 days after initial PD catheter implantation. Overall, we found that 15.5% of catheters required revision, removal, or a second catheter placement within 90 days. The odds of requiring a follow-up procedure was 36% higher for interventional radiologists and 86% higher for interventional nephrologists compared with general surgeons. Further research is needed to understand how to optimize the function of catheters across different operator types. BACKGROUND: The US government has implemented incentives to increase the use of PD. Successful placement of PD catheters is an important step to increasing PD utilization rates. Our objective was to compare initial outcomes after PD catheter placement by different types of operators. METHODS: We included PD-naïve patients insured by Medicare who had a PD catheter inserted between 2010 and 2019. We examined the association between specialty of the operator (general surgeon, vascular surgeon, interventional radiologist, or interventional nephrologist) and odds of needing a follow-up procedure, which we defined as catheter removal, replacement, or revision within 90 days of the initial procedure. Mixed logistic regression models clustered by operator were used to examine the association between operator type and outcomes. RESULTS: We included 46,973 patients treated by 5205 operators (71.1% general surgeons, 17.2% vascular surgeons, 9.7% interventional radiologists, 2.0% interventional nephrologists). 15.5% of patients required a follow-up procedure within 90 days of the initial insertion, of whom 2.9% had a second PD catheter implanted, 6.6% underwent PD catheter removal, and 5.9% had a PD catheter revision within 90 days of the initial insertion. In models adjusted for patient and operator characteristics, the odds of requiring a follow-up procedure within 90 days were highest for interventional nephrologists (HR, 1.86; 95% confidence interval [CI], 1.56 to 2.22) and interventional radiologists (odds ratio, 1.36; 95% CI, 1.17 to 1.58) followed by vascular surgeons (odds ratio, 1.06; 95% CI, 0.97 to 1.14) compared with general surgeons. CONCLUSIONS: The probability of needing a follow-up procedure after initial PD catheter placement varied by operator specialty and was higher for interventionalists and lowest for general surgeons.

Hybrid Method for Peritoneal Dialysis Catheter Insertion: A New Technique for Improved Outcomes and Reduced Costs.

INTRODUCTION: Peritoneal dialysis (PD) is a well-established treatment choice for end-stage kidney disease (ESKD). While there are several methods for PD catheter insertion, they each have limitations. In this study, we present a new hybrid method for PD catheter insertion and compare it to the conventional laparoscopic method. METHODS: This retrospective study included 171 patients who were undergoing their first PD catheter insertion, and a total of 20% of the enrolled patients had a past medical history of abdominal surgery. Out of these, 101 patients underwent the laparoscopic method and 70 underwent a new invented hybrid method. The study aimed to compare the surgical outcomes, incidence of early and late complications, hospital stay, and medical expenses between the two groups. RESULTS: There were no notable differences in basic demographic features and comorbid conditions between the two groups. The results of our data revealed that the hybrid group had a significantly shorter break-in period and did not require temporary hemodialysis. Additionally, length of hospital stay and medical costs were significantly lower in the hybrid group (all p < 0.05). The incidence of early complications was lower in the hybrid group, while the incidence of late complications was comparable between the two groups. CONCLUSION: Our study demonstrates that the hybrid method of PD catheter insertion provides a safe and efficient alternative to the traditional laparoscopic method, enabling urgent-start PD and reducing hospital stays and medical expenses. Our findings support the use of the hybrid method as a new standard of care for ESKD patients undergoing PD catheter insertion.

Economic evaluation of three dialysis methods in patients with end-stage renal disease in China.

OBJECTIVES: End-stage renal disease (ESRD) may result in different degrees of physical and psychological pain. Automated peritoneal dialysis (APD), continuous ambulatory peritoneal dialysis (CAPD), and hemodialysis (HD) as the main treatment methods lead to a heavy burden on social economic and family financial. However, there are few studies on the economic evaluation of the three dialysis methods in China. METHODS: Cost-effectiveness analyses were performed using Markov models based on longitudinal data for 15 years of different modalities in Kunshan City, China. Direct cost derived from medical insurance information system, and indirect cost referred to as loss of productivity. Sensitivity analyses were conducted to study uncertainty. RESULTS: The per capita total cost of CAPD was 664,027.00 yuan, the per capita utility is 5.9105. The per capita total cost of APD was 858,800.65 yuan, the per capita utility is 6.4548. The per capita total cost of HD was 1,281,213.64 yuan, the per capita utility is 6.1356. When CAPD was compared with HD, Incremental Cost-Effectiveness Ratio (ICER) was 1,323,389.53 yuan per QALY, compared with APD, ICER was 357,848.13 yuan per QALY. ICER value suggests that APD was cost-effective compared with CAPD and HD at a willingness-to-pay threshold of 538,200 yuan. CONCLUSION: Our research showed that APD is the most appropriate and HD is the worst in terms of cost-effectiveness. However, in fact, HD accounts for a high proportion in China, so some relevant policy suggestions need to be implemented to change the current situation.

Retraining programme for older patients undergoing peritoneal dialysis: A randomised controlled trial.

BACKGROUND: Peritonitis is a common cause of hospitalisation and death among patients undergoing peritoneal dialysis. Periodic retraining is recommended to prevent peritonitis, especially in older adults. OBJECTIVES: We evaluated the effectiveness of a retraining programme for reducing peritonitis and exit site infection rates in older adults on peritoneal dialysis. The cost-benefit ratio was also calculated. DESIGN: A two-arm prospective randomised controlled trial. PARTICIPANTS: One hundred and thirty patients aged 55 years or older were recruited. Participants were randomly assigned to the intervention or control group. While both groups received usual care, the intervention group received a retraining programme (a knowledge and practical assessment and a one-on-one retraining session) 90 days after starting home-based continuous ambulatory peritoneal dialysis therapy. MEASUREMENTS: The outcomes included peritonitis rate, exit site infection rate and direct medical costs at 180, 270, and 360 days after starting home-based continuous ambulatory peritoneal dialysis therapy. RESULTS: No significant differences were found in the baseline characteristics between groups. The peritonitis rates were 0.11 episodes per patient-year in the intervention group versus 0.13 in the control group. The incidence of exit site infection was 20.0% in the intervention group and 12.3% in the control group. The cost-benefit ratio of retraining was 1:9.6. None of the results were statistically significant. CONCLUSIONS: The absence of statistical significance may be partly explained by the premature termination of the study. Large-scale multi-centre trials are warranted to examine the effectiveness of retraining. The timing and long-term effects of retraining also need to be examined.

Estimating the cost of home dialysis in Tunisia: Application of the Activity-based costing methodology.

INTRODUCTION: In Tunisia, in-centre haemodialysis (ICHD) is the most common type of dialysis. Despite the increasing demand, the number of haemodialysis machines per 100,000 inhabitants is still low. Home Haemodialysis (HHD) is a candidate solution to this problem. Despite its confirmed benefits over ICHD, HHD has not taken place in Tunisia. AIM: To describe the processes of home dialysis modalities, especially HHD, evaluate their costs, analyse them, in the context of medical practice in public health structures in Tunisia. METHOD: The Activity-Based Costing technique was applied: the processes of home dialysis modalities were modelled, the main activity and resource cost drivers identified, and cost equations developed. Based on data from the nephrology department of Sahloul hospital, the cost per session and annual costs for each home dialysis modality were calculated and analyzed. RESULTS: Home Peritoneal Dialysis, already implemented in Tunisia; presented the lowest annual cost per patient 25344 TND versus 29232 TND for Conventional HHD and 54144 TND for Short-Daily HHD. The cost per session of the Short-Daily HHD (188,8 TND) was comparable to ICHD (180 TND). Consumables presented the most expensive resource for these modalities. Finally, the cost structure of HHD was comparable in Tunisia and France as well as in previous costing studies. CONCLUSION: The cost of one session of HHD is estimated to 188,8 TND. The Tunisian ministry of health could adopt a flexible policy to start HHD program by implementing Conventional HHD first.

Automated peritoneal dialysis as a cost-effective urgent-start dialysis option for ESRD patients: A prospective cohort study.

BACKGROUND: Several studies have reported the feasibility of urgent-start peritoneal dialysis (PD) as an alternative to hemodialysis (HD) using a central venous catheter (CVC). However, the cost-effectiveness of automated peritoneal dialysis (APD) as an urgent-start dialysis modality has not been directly evaluated, especially in China. METHODS: We prospectively enrolled patients with end-stage renal disease (ESRD) who required urgent-start dialysis at a single center from March 2019 to November 2020. Patients were grouped according to their urgent-start dialysis modality (APD and HD). Urgent-start dialysis conducted until 14 days after PD catheter insertion. Then, PD was maintained. Each patient was followed until July 2021 or death or loss to follow-up. The primary outcome was the incidence of short-term dialysis-related complications. The secondary outcome was the cost and duration of the initial hospitalization. Technique survival, peritonitis-free or bacteriamia-free survival and patient survival were also compared. RESULTS: Sixty-eight patients were included in the study, of whom 36 (52.9%) patients were in APD group. Mean follow-up duration was 20.1 months. Compared with the HD group, the APD group had significantly fewer short-term dialysis-related complications. The cost of initial hospitalization was also significantly lower in APD patients. There was no significant difference between APD and HD patients with respect to duration of the initial hospitalization, technique survival rate, peritonitis-free or bacteriemia-free survival rate, and patient survival rate. CONCLUSION: Among ESRD patients with an urgent need for dialysis, APD as urgent-start dialysis modality, compared with HD using a CVC, resulted in fewer short-term dialysis-related complications and lower cost.

Assessment of the effect of perineural dexmedetomidine on oxidative stress during peritoneal dialysis catheter insertion: a randomized, controlled trial.

PURPOSE: This study aimed to evaluate the effect of the addition of dexmedetomidine to ropivacaine on oxidative stress during transversus abdominis plane (TAP) and rectus sheath (RS) blockades for patients with end-stage renal disease (ESRD) undergoing peritoneal dialysis (PD) catheter insertion. METHODS: Sixty patients with ESRD undergoing PD catheter insertion to receive left ultrasound-guided TAP and RS blockades were randomly divided into two groups: the dexmedetomidine plus ropivacaine group (25 mL of 0.3% ropivacaine + 1 µg/kg dexmedetomidine) and the ropivacaine group (25 mL of 0.3% ropivacaine). Primary outcomes were oxidative stress marker levels during the procedure. RESULTS: A total of 60 patients (30 patients in each group) were evaluated. Compared with the ropivacaine group, the dexmedetomidine plus ropivacaine group had significantly lower serum malondialdehyde levels (P < 0.05) and increased glutathione peroxidase (P < 0.01) and superoxide dismutase levels at 24 h after the procedure (P < 0.01). CONCLUSION: The addition of 1 µg/kg of dexmedetomidine to ropivacaine for ultrasound-guided TAP and RS blockades could inhibit oxidative stress in patients with ESRD undergoing PD catheter insertion. Trial registration This study was registered at www.chictr.org.cn on June 7, 2021 (ChiCTR2100047050).

Self-assessment sheet submission rate predicts technique survival in patients initiating peritoneal dialysis.

AIM: Patients play a crucial role in preventing peritoneal dialysis (PD)-related events, including peritonitis and fluid overload, as PD procedures are mainly carried out at home. We asked patients to submit a PD self-assessment sheet at each outpatient visit in our daily clinical practice and evaluated its usefulness for outcomes in patients initiating PD. METHODS: This retrospective cohort study included patients who underwent PD catheter insertion between January 2008 and October 2018. The submission rate of a PD self-assessment sheet was calculated from medical records until PD cessation or study completion (October 2020). The association between the submission rate and technique survival was analysed. RESULTS: Among the 105 recruited patients (78 men, 60.4 ± 12.2 years), 44 discontinued PD and transferred to haemodialysis during the study period. The follow-up was 52.3 (28.7-79.3) months, and the median submission rate was 78%. The log-rank test showed that technique survival was significantly better in patients with a submission rate ≥ 78% than those with a submission rate <78% (p = .006). The submission rate remained significantly associated with less technique failure (hazard ratio 0.88 per 10%, p = .002) by the Cox regression analysis adjusted for age, sex, Charlson comorbidity index, estimated glomerular filtration rate and geriatric nutritional risk index. CONCLUSION: The submission rate of a PD self-assessment sheet is useful as a predictor of technique survival in patients initiating PD. Instruction that increases submission may improve technique survival in PD patients.

Current costs of dialysis modalities: A comprehensive analysis within the United Kingdom.

BACKGROUND: Previous evidence suggests home-based dialysis to be more cost-effective than unit-based or hospital-based dialysis. However, previous analyses to quantify the costs of different dialysis modalities have used varied perspectives, different methods, and required assumptions due to lack of available data. The National Institute for Health and Care Excellence reports uncertainty about the differences in costs between home-based and unit-based dialysis. This uncertainty limits the ability of policy makers to make recommendations based on cost effectiveness, which also impacts on the ability of budget holders to model the impact of any service redesign and to understand which therapies deliver better value. The aim of our study was to use a combination of top-down and bottom-up costing methods to determine the direct medical costs of different dialysis modalities in one UK nation (Wales) from the perspective of the National Health Service (NHS). METHODS: Detailed hybrid top-down and bottom-up micro-costing methods were applied to estimate the direct medical costs of dialysis modalities across Wales. Micro-costing data was obtained from commissioners of the service and from interviews with renal consultants, nurses, accountants, managers and allied health professionals. Top-down costing information was obtained from the Welsh Renal Clinical Network (who commission renal services across Wales) and the Welsh Ambulance Service Trust. RESULTS: The annual direct cost per patient for home-based modalities was £16,395 for continuous ambulatory peritoneal dialysis (CAPD), £20,295 for automated peritoneal dialysis (APD) and £23,403 for home-based haemodialysis (HHD). The annual cost per patient for unit-based modalities depended on whether or not patients required ambulance transport. Excluding transport, the cost of dialysis was £19,990 for satellite units run in partnership with independent sector providers and £23,737 for hospital units managed and staffed by the NHS. When ambulance transport was included, the respective costs were £28,931 and £32,678, respectively. CONCLUSION: Our study is the most comprehensive analysis of the costs of dialysis undertaken thus far in the United Kingdom and clearly demonstrate that CAPD is less costly than other dialysis modalities. When ambulance transport costs are included, other home therapies (APD and HHD) are also less costly than unit-based dialysis. This detailed analysis of the components that contribute to dialysis costs will help inform future cost-effectiveness studies, inform healthcare policy and drive service redesign.

Three years evaluation of peritoneal dialysis and hemodialysis absorption costing: perspective of the service provider compared to funds transfers from the public and private healthcare systems.

INTRODUCTION: 72% of renal replacement therapy (RRT) clinics in Brazil are private. However, regarding payment for dialysis therapy, 80% of the patients are covered by the Unified Health System (SUS) and 20% by private healthcare (PH). OBJECTIVES: To evaluate costs for peritoneal dialysis (PD) and hemodialysis (HD) from the perspective of the service provider and compare with fund transfers from SUS and private healthcare. METHODS: The absorption costing method was applied in a private clinic. Study horizon: January 2013 - December 2016. Analyzed variables: personnel, medical supplies, tax expenses, permanent assets, and labor benefits. The input-output matrix method was used for analysis. RESULTS: A total of 27,666 HD sessions were performed in 2013, 26,601 in 2014, 27,829 in 2015, and 28,525 in 2016. There were 264 patients on PD in 2013, 348 in 2014, 372 in 2015, and 300 in 2016. The mean monthly cost of the service provider was R$ 981.10 for a HD session for patients with hepatitis B; R$ 238.30 for hepatitis C; R$197.99 for seronegative patients; and R$ 3,260.93 for PD. Comparing to fund transfers from SUS, absorption costing yielded a difference of -269.7% for hepatitis B, +10.2% for hepatitis C, -2.0% for seronegative patients, and -29.8% for PD. For PH fund transfers, absorption costing for hepatitis B yielded a difference of -50.2%, +64.24% for hepatitis C, +56.27% for seronegative patients, and +48.26 for PD. CONCLUSION: The comparison of costs of dialysis therapy from the perspective of the service provider with fund transfers from SUS indicated that there are cost constraints in HD and PD.

Assessment of peritoneal thickness using CT in relation to dialysis adequacy in peritoneal dialysis patients.

Studies assessing peritoneal thickness by CT in peritoneal dialysis (PD) patients are lacking. In this study, we aimed to investigate the association between peritoneal thickness as measured by CT and dialysis adequacy with peritoneal membrane characteristics in PD patients. Ninety-four PD patients were enrolled. Peritoneal thickness was measured by CT. Patients with and without a decrease in Kt/V of at least 0.3 over time were classified as Group 1 and Group 2, respectively. An increase of 0.1 unit of dialysate/plasma (D/P) creatinine over time were considered significant. The relationship between peritoneal membrane thickness, change in Kt/V, and peritoneal membrane characteristics were investigated. There were 31 (33.0%) patients in Group 1. The duration of PD (86.0 ± 64.1 vs. 59.6 ± 45.2 months, p: 0.023), peritoneal thickness (1.02 ± 0.37 vs. 0.87 ± 0.21 mm, p: 0.015), peritoneal calcification (7 [22.6%] vs. 3 [4.8%] patients, p: 0.013], increased D/P creatinine ratio (14 [45.2%] vs. 14 [22.2%] patients, p: 0.031) and CRP (13.9 ± 11.2 vs. 7.1 ± 4.8 mg/L, p: 0.045) were significantly higher in Group 1, whereas albumin (3.6 ± 0.5 vs. 3.8 ± 0.6 g/dL, p: 0.047) and parathyroid hormone (355.2 ± 260.2 vs. 532.1 ± 332.9 ng/L, p: 0.015) levels were significantly lower. Peritoneal thickness was significantly correlated with duration of PD (r: 0.775, p < 0.001) and CRP (r: 0.282, p: 0.006). Regression analysis showed that peritoneal thickness (Exp (B) [95% CI]: 0.029 [0.003-0.253], p: 0.001) was independent predictor of decreased Kt/V in PD patients. In conclusion, prolonged PD duration and increased peritoneal thickness are associated with a decrease in Kt/V over time. CT may be an alternative and noninvasive method instead of peritoneal biopsy for determining the structural changes of the peritoneal membrane .

Health Outcomes and Cost Considerations of Assisted Peritoneal Dialysis: A Narrative Review.

BACKGROUND: Peritoneal dialysis (PD) is underutilized in many parts of the world despite pro-PD health policies. The physical and cognitive demands of PD means that over half of eligible patients require some form of assistance. As such, many countries now offer assisted PD (aPD) programs to help patients start or stay on PD as opposed to in-center hemodialysis (HD). In order to evaluate the potential scope of aPD, it is important to review the outcomes and cost considerations of aPD. SUMMARY: We reviewed available data from different countries and regions for health outcomes between aPD and in-center HD, with a focus on quality of life (QoL), mortality, hospitalization, and technique survival. We also evaluated studies discussing the overall costs of delivering aPD, including training, operating costs, and indirect costs and compared these to in-center HD costs for the same regions. Key Messages: aPD patients are older and more frail than either self-care PD patients and many in-center HD patients. We found no evidence for any difference in QoL, mortality, or hospitalization between aPD and in-center HD after adjustment for these differences. There is some evidence for an association between nurse assistance and improved technique survival as compared to family assistance or self-care PD. Despite increased cost of providing assistance in PD, it is still significantly less expensive than in-center HD in Western Europe and Canada.

Perspectives on blood pressure by patients on haemo- and peritoneal dialysis.

AIM: The management of blood pressure in patients requiring dialysis remains challenging and controversial. This study aimed to describe the perspectives of patients treated with peritoneal or haemodialysis regarding blood pressure, to inform patient-centred management. METHODS: We conducted a secondary thematic analysis of qualitative data from multiple data sets derived from the Standardised Outcomes in Nephrology (SONG) initiative. We extracted and analysed the responses of adult patients (aged 18 years or over) on haemodialysis and peritoneal dialysis, and their caregivers. Qualitative data were extracted from 26 focus groups, two international Delphi surveys and two consensus workshops completed as part of the SONG-Haemodialysis and SONG-Peritoneal dialysis projects. RESULTS: Collectively, the studies involved 644 patients and caregivers from 86 countries. We identified four themes: helpless and incapacitated (including the subthemes of disabling and debilitating symptoms, limiting ability to work, fear of "crashes" - a sudden drop in blood pressure - forced to depend on others); dismissed and ignored (disregarded as a problem, lacking information, education and reassurance); escalating medication burden; and taking control for improved self-management (determining thresholds in fluid management, establishing a routine for proactive monitoring). CONCLUSION: Blood pressure symptoms are debilitating for patients on dialysis and exacerbated by a perceived lack of information about how to understand and manage these symptoms. More patient-centred management of blood pressure, particularly symptom-causing blood pressure, in patients on dialysis is likely to substantially improve patient satisfaction and outcomes.

Challenges of access to kidney care for children in low-resource settings.

Kidney disease is a global public health concern across the age spectrum, including in children. However, our understanding of the true burden of kidney disease in low-resource areas is often hampered by a lack of disease awareness and access to diagnosis. Chronic kidney disease (CKD) in low-resource settings poses multiple challenges, including late diagnosis, the need for ongoing access to care and the frequent unavailability of costly therapies such as dialysis and transplantation. Moreover, children in such settings are at particular risk of acute kidney injury (AKI) owing to preventable and/or reversible causes - many children likely die from potentially reversible kidney disease because they lack access to appropriate care. Acute peritoneal dialysis (PD) is an important low-cost treatment option. Initiatives, such as the Saving Young Lives programme, to train local medical staff from low-resource areas to provide care for AKI, including acute PD, have already saved hundreds of children. Future priorities include capacity building for both educational purposes and to provide further resources for AKI management. As local knowledge and confidence increase, CKD management strategies should also develop. Increased awareness and advocacy at both the local government and international levels will be required to continue to improve the diagnosis and treatment of AKI and CKD in children worldwide.

Home Dialysis in the Coronavirus Disease 2019 Era.

The coronavirus disease 2019 pandemic has had a significant impact on patients with end-stage kidney disease and their care, especially given the potential for severe coronavirus disease 2019 in those with a depressed immune status. Patients receiving in-center hemodialysis have been particularly affected by this pandemic because of their need to travel multiple times a week to receive treatment. Although patients on home dialysis are able to avoid such exposure, they face their own unique challenges. In this review, we will discuss the challenges posed by the coronavirus disease 2019 pandemic for patients on home dialysis, the impact of coronavirus disease 2019 on various aspects of their care, and the resultant rapid adaptations in policy/health-care delivery mechanisms with implications for the future care of patients on home dialysis.

The Peritoneal Dialysis Transfer Set Replacement Procedure.

Peritoneal dialysis transfer sets (extension lines) are replaced every six to nine months to minimize peritoneal dialysis catheter complications. The aim of this study was to compare a revised non-bag transfer set exchange procedure with the standard bag exchange procedure on nursing time, costs, and safety. Thirty-three people were randomized to two groups - a standard bag exchange procedure group (n = 16) and a non-bag transfer set exchange procedure group (n = 17). The standard bag exchange procedure took a median of 32 minutes (interquartile range [IQR] 25 to 38 minutes) compared to the non-bag transfer set exchange procedure of 6 minutes (IQR 4 to 8 minutes) (p Ò 0.0001). There was one episode of peritonitis in each group within the 72-hour follow-up period. The average cost of the non-bag transfer set exchange procedure was $24.54 lower, a 37% cost reduction. This study has shown the revised non-bag transfer set replacement procedure appears to be safe, consume less participant and staff time, and decreases costs.

The current and future landscape of dialysis.

The development of dialysis by early pioneers such as Willem Kolff and Belding Scribner set in motion several dramatic changes in the epidemiology, economics and ethical frameworks for the treatment of kidney failure. However, despite a rapid expansion in the provision of dialysis - particularly haemodialysis and most notably in high-income countries (HICs) - the rate of true patient-centred innovation has slowed. Current trends are particularly concerning from a global perspective: current costs are not sustainable, even for HICs, and globally, most people who develop kidney failure forego treatment, resulting in millions of deaths every year. Thus, there is an urgent need to develop new approaches and dialysis modalities that are cost-effective, accessible and offer improved patient outcomes. Nephrology researchers are increasingly engaging with patients to determine their priorities for meaningful outcomes that should be used to measure progress. The overarching message from this engagement is that while patients value longevity, reducing symptom burden and achieving maximal functional and social rehabilitation are prioritized more highly. In response, patients, payors, regulators and health-care systems are increasingly demanding improved value, which can only come about through true patient-centred innovation that supports high-quality, high-value care. Substantial efforts are now underway to support requisite transformative changes. These efforts need to be catalysed, promoted and fostered through international collaboration and harmonization.