Lessons learned from the Alberta Border Testing Pilot Program.

Background: During the Coronavirus disease (COVID-19) pandemic, countries implemented border control and quarantine measures to reduce transmission. The Alberta Border Testing Pilot Program (ABTPP) allowed international travellers entering Alberta to reduce their quarantine period following two negative COVID-19 tests. We evaluated participant experiences with the ABTPP and implementation. Method: We used a parallel convergent mixed-methods design to explore participant experiences through electronic web-based questionnaires (n = 21,089; n = 13,839) and semi-structured telephone interviews (n = 30). We evaluated implementation through three staff focus groups (n = 11). We analysed questionnaires using descriptive statistics and analysed interviews using inductive and deductive thematic analysis. We deductively coded focus group data using the 2009 Consolidated Framework for Implementation Research (CFIR). Results: Questionnaires indicated minimal issues with registration forms (91.7%), symptom reports (95.5%), and COVID-19 testing (95.7%). Most respondents (95.1%) expressed willingness to participate in the ABTPP again. Interviews revealed three themes related to participant experience: program efficiency, clarity of information, and requisite effort. Focus groups identified key implementation facilitators including the single health information system, strong stakeholder partnerships, and good communication across partnerships. Barriers included program complexity, implementation timeline, and evolving external context. Discussion: Participants reported high satisfaction with the ABTPP. Border testing programs should have high efficiency, require low effort, and use messaging that is clear and consistent. The effective implementation of border testing programs may be facilitated by strong leadership, adaptability, automated components, good communication, and simple technology. Learnings from participants and staff may help improve the implementation of border control programs for future pandemics or other emergencies. Conclusions: The ABTTP was a novel border control measure during the COVID-19 pandemic. Our evaluation of both participant and staff experiences demonstrated high levels of traveller satisfaction and identified areas for improvement that can inform the development of future border control measures.

The cost-effectiveness of non-invasive stool-based colorectal cancer screening offerings from age 45 for a commercial and medicare population.

AIM: The United States Preventive Services Taskforce (USPSTF) recently recommended lowering the age for average-risk colorectal cancer (CRC) screening from 50 to 45 years. While initiating screening at age 45 versus 50 provides a greater opportunity for CRC early detection and prevention, the full profile of benefits, risks, and cost-effectiveness of expanding the screen-eligible population requires further evaluation. MATERIALS AND METHODS: The costs and clinical outcomes for screening at age 45 for triennial multi-target stool DNA [mt-sDNA], and other non-invasive stool-based modalities (annual fecal immunochemical test [FIT] and annual fecal-occult blood test [FOBT]), were estimated using the validated CRC-AIM microsimulation model over a lifetime horizon. Test sensitivity and specificity inputs were based on 2021 USPSTF modeling analyses; adherence rates were based on published real-world data and the costs of the screening test, follow-up colonoscopies, complications, and CRC care were included. Outcomes are reported from the perspective of a United States payer as clinical, life-years gained (LYG), and incremental cost-effectiveness ratio (ICER); stool-based and follow-up colonoscopy adherence ranges were explored in one-way, probabilistic and threshold analyses. RESULTS: When compared to initiation of CRC screening at age 45 versus 50, all modalities reduced both the incidence of and mortality from CRC and increased LYG. Initiating CRC screening at age 45 was cost-effective with an ICER of $59,816 and $35,857 per quality-adjusted life year (QALY) for mt-sDNA versus FIT and FOBT, respectively. In the threshold analyses, at equivalent rates to stool-based screening, mt-sDNA was always cost-effective at a willingness-to-pay threshold of $100,000 per QALY versus FIT and FOBT. CONCLUSIONS: Initiating average-risk CRC screening at age 45 instead of age 50 increases the estimated clinical benefit by reducing disease burden while remaining cost-effective. Among stool-based screening modalities, mt-sDNA provides the most clinical benefit in a Commercial and Medicare population.

Screening for colorectal cancer at an earlier age can provide additional benefits in terms of reducing disease complications and death. This study looked at the occurrence of disease complications and costs related to different types of colorectal cancer screening in 45 vs. 50 year old people. A model that has previously been used to project lifetime costs and disease complications in people receiving colorectal cancer screening was used in this study. We found that beginning screening at age 45 as compared to at age 50 reduced disease complications and death. In people who started screening at age 45, one particular screening type (multitarget stool DNA) was found to provide better economic value to a greater degree relative to other strategies. These findings were consistent even when many inputs into the model were changed over reasonable ranges. Therefore, our study helps show that starting screening in people at age 45 with average risk for developing colorectal cancer is beneficial by reducing disease complications and deaths, and that multitarget stool DNA is the strategy that provides the most benefits while being economically justifiable.

Cost-effectiveness analysis of HIV pre-exposure prophylaxis in Japan.

BACKGROUND: While global efforts have been made to prevent transmission of HIV, the epidemic persists. Men who have sex with men (MSM) are at high risk of infection. Despite evidence of its cost-effectiveness in other jurisdictions, pre-exposure prophylaxis (PrEP) for MSM is neither approved nor reimbursed in Japan. METHOD: The cost-effectiveness analysis compared the use of once daily PrEP versus no PrEP among MSM over a 30-year time horizon from a national healthcare perspective. Epidemiological estimates for each of the 47 prefectures informed the model. Costs included HIV/AIDS treatment, HIV and testing for sexually transmitted infections, monitoring tests and consults, and hospitalization costs. Analyses included health and cost outcomes, as well as the incremental cost-effectiveness ratio (ICER) reported as the cost per quality-adjusted life year (QALY) for all of Japan and each prefecture. Sensitivity analyses were performed. FINDINGS: The estimated proportion of HIV infections prevented with the use of PrEP ranged from 48% to 69% across Japan, over the time horizon. Cost savings due to lower monitoring costs and general medical costs were observed. Assuming 100% coverage, for Japan overall, daily use of PrEP costs less and was more effective; daily use of PrEP was cost-effective at a willingness to pay threshold of ¥5,000,000 per QALY in 32 of the 47 prefectures. Sensitivity analyses found that the ICER was most sensitive to the cost of PrEP. INTERPRETATION: Compared to no PrEP use, once daily PrEP is a cost-effective strategy in Japanese MSM, reducing the clinical and economic burden associated with HIV.

HIV remains an epidemic, and men who have sex with men (MSM) are at higher risk of infection. Pre-exposure prophylaxis (PrEP) is a preventive treatment that can reduce someone's risk of getting infected with HIV and has been shown to provide good value for money. PrEP, however, is neither approved nor reimbursed in Japan. In order to determine the value for money in Japan, an economic model was developed to estimate the number of HIV infections and AIDS cases that could be avoided, along with whether daily use of PrEP among MSM in Japan is cost effective. Findings showed that with use of daily PrEP, the proportion of HIV infections and AIDS cases prevented was 63% and 59%, respectively, across Japan. Over a 30-year time horizon, daily use of PrEP would cost the health system less and be more effective than no use of PrEP. Daily PrEP should therefore be considered for reimbursement in MSM in Japan, given its value for money.

A Critical Appraisal of Matching-Adjusted Indirect Comparisons in Spinal Muscular Atrophy.

In the absence of head-to-head trials, indirect treatment comparisons (ITCs) are often used to compare the efficacy of different therapies to support decision-making. Matching-adjusted indirect comparison (MAIC), a type of ITC, is increasingly used to compare treatment efficacy when individual patient data are available from one trial and only aggregate data are available from the other trial. This paper examines the conduct and reporting of MAICs to compare treatments for spinal muscular atrophy (SMA), a rare neuromuscular disease. A literature search identified three studies comparing approved treatments for SMA including nusinersen, risdiplam, and onasemnogene abeparvovec. The quality of the MAICs was assessed on the basis of the following principles consolidated from published MAIC best practices: (1) justification for the use of MAIC is clearly stated, (2) the included trials with respect to study population and design are comparable, (3) all known confounders and effect modifiers are identified a priori and accounted for in the analysis, (4) outcomes should be similar in definition and assessment, (5) baseline characteristics are reported before and after adjustment, along with weights, and (6) key details of a MAIC are reported. In the three MAIC publications in SMA to date, the quality of analysis and reporting varied greatly. Various sources of bias in the MAICs were identified, including lack of control for key confounders and effect modifiers, inconsistency in outcome definitions across trials, imbalances in important baseline characteristics after weighting, and lack of reporting key elements. These findings highlight the importance of evaluating MAICs according to best practices when assessing the conduct and reporting of MAICs.

Remdesivir for Hospitalized COVID-19 Patients in the United States: Optimization of Health Care Resources.

INTRODUCTION: In addition to significant morbidity and mortality, the coronavirus disease (COVID-19) has strained health care systems globally. This study investigated the cost-effectiveness of remdesivir + standard of care (SOC) for hospitalized COVID-19 patients in the USA. METHODS: This cost-effectiveness analysis considered direct and indirect costs of remdesivir + SOC versus SOC alone among hospitalized COVID-19 patients in the US. Patients entered the model stratified according to their baseline ordinal score. At day 15, patients could transition to another health state, and on day 29, they were assumed to have either died or been discharged. Patients were then followed over a 1-year time horizon, where they could transition to death or be rehospitalized. RESULTS: Treatment with remdesivir + SOC avoided, per patient, a total of 4 hospitalization days: two general ward days and a day for both the intensive care unit and the intensive care unit plus invasive mechanical ventilation compared to SOC alone. Treatment with remdesivir + SOC presented net cost savings due to lower hospitalization and lost productivity costs compared to SOC alone. In increased and decreased hospital capacity scenarios, remdesivir + SOC resulted in more beds and ventilators being available versus SOC alone. CONCLUSIONS: Remdesivir + SOC alone represents a cost-effective treatment for hospitalized patients with COVID-19. This analysis can aid in future decisions on the allocation of healthcare resources.

Exploring the treatment gap among patients with osteoporosis-related fractures in France.

The use of anti-osteoporosis treatment following a diagnosis of osteoporosis with fracture or a relevant fragility fracture remains low in France. Initiating an anti-resorptive may reduce the incidence of a subsequent fracture by 60%. PURPOSE: To describe real-world osteoporosis treatment patterns in individuals with a fragility fracture in France and to explore the impact of initiating treatment on the risk of subsequent fracture. METHODS: A retrospective cohort study, using the national French Health Insurance claims database. Males and females 50 years and over, with a hospital discharge diagnosis of osteoporosis with fracture or a relevant fragility fracture between 2011 and 2014, were included and followed until death or the end of 2016, whichever came first. The primary outcome was the proportion of patients receiving anti-osteoporosis treatments prior to and post-index fracture. Change in fracture rates before and after treatment initiation was assessed in an exploratory analysis. RESULTS: A total of 574,133 patients (138,567 males, 435,566 females) had a qualifying index fracture. The proportion of patients receiving any anti-osteoporosis treatment increased pre-index fracture to post-index fracture from 2.2 to 5.6% among males, and from 11.8 to 18.2% among females. Oral bisphosphonates were the most prescribed anti-osteoporosis treatment for both males and females among post-index fractures (60.6% and 68.8% of patients initiating treatment). Following initiation of anti-resorptives, the incidence of subsequent fracture was reduced by 60% (rate ratio (RR): 0.40, 95% confidence interval [CI]: 0.34-0.45). CONCLUSION: Anti-osteoporosis treatment following an index fracture in France remains low. Improved identification and pharmacologic management of patients at risk of fragility fractures are necessary to reduce the risk of subsequent fractures.

Impact of Perioperative Complications on Living Kidney Donor Health-Related Quality of Life and Mental Health: Results From a Prospective Cohort Study.

BACKGROUND: Although living kidney donation is safe, some donors experience perioperative complications. OBJECTIVE: This study explored how perioperative complications affected donor-reported health-related quality of life, depression, and anxiety. DESIGN: This research was a conducted as a prospective cohort study. SETTING: Twelve transplant centers across Canada. PATIENTS: A total of 912 living kidney donors were included in this study. MEASUREMENTS: Short Form 36 health survey, Beck Depression Inventory and Beck Anxiety Inventory. METHODS: Living kidney donors were prospectively enrolled predonation between 2009 to 2014. Donor perioperative complications were graded using the Clavien-Dindo classification system. Mental and physical health-related quality of life was assessed with the 3 measurements; measurements were taken predonation and at 3- and 12-months postdonation. RESULTS: Seventy-four donors (8%) experienced a perioperative complication; most were minor (n = 67 [91%]), and all minor complications resolved before hospital discharge. The presence (versus absence) of a perioperative complication was associated with lower mental health-related quality of life and higher depression symptoms 3-month postdonation; neither of these differences persisted at 12-month. Perioperative complications were not associated with any changes in physical health-related quality of life or anxiety 3-month postdonation. LIMITATIONS: Minor complications may have been missed and information on complications postdischarge were not collected. No minimal clinically significant change has been defined for kidney donors across the 3 measurements. CONCLUSIONS: These findings highlight a potential opportunity to better support the psychosocial needs of donors who experience perioperative complications in the months following donation. TRIAL REGISTRATION: NCT00319579 and NCT00936078.

CONTEXTE: Bien que le don vivant d'un rein soit une procédure sécuritaire, certains donneurs souffrent tout de même de complications périopératoires. OBJECTIFS: Cette étude a examiné l'incidence des complications périopératoires sur la qualité de vie liée à la santé et les symptômes de dépression et d'anxiété rapportés par les donneurs. TYPE D'ÉTUDE: Étude de cohorte prospective. CADRE: Douze centers de transplantation à travers le Canada. SUJETS: 912 donneurs vivants d'un rein. MESURES: Un questionnaire abrégé de 36 questions sur l'état de santé, l'inventaire de dépression Beck et l'inventaire d'anxiété Beck. MÉTHODOLOGIE: Les donneurs ont été inscrits avant le don de façon prospective entre 2009 et 2014. Les complications périopératoires des donneurs ont été classées à l'aide du système de classification Clavien-Dindo. La qualité de vie liée à la santé physique et mentale a été évaluée à l'aide des trois outils de mesure; ces mesures ont été faites avant le don, puis 3 et 12 mois après le don. RÉSULTATS: Au total, 74 donneurs (8 %) ont souffert d'une complication périopératoire; la plupart étaient mineures (n = 67 [91 %]) et ont été résolues avant le congé de l'hôpital. La présence (par rapport à l'absence) d'une complication périopératoire a été associée à une plus faible qualité de vie liée à la santé mentale et à des symptômes de dépression plus graves 3 mois après le don; aucune de ces différences n'a persisté après 12 mois. Les complications périopératoires n'ont pas été associées à des changements dans la qualité de vie liée à la santé physique ou à l'anxiété 3 mois après le don. LIMITES: Certaines complications mineures ont pu être manquées. L'information sur les complications survenues après le congé n'a pas été recueillie. Dans les trois outils de mesure, aucune variation minimale cliniquement significative n'a été définie pour les donneurs d'un rein. CONCLUSION: Ces résultats soulignent une occasion de mieux répondre aux besoins psychosociaux des donneurs d'un rein qui présentent des complications périopératoires dans les mois suivant le don.

COVID-19 infection among international travellers: a prospective analysis.

OBJECTIVES: This report estimates the risk of COVID-19 importation and secondary transmission associated with a modified quarantine programme in Canada. DESIGN AND PARTICIPANTS: Prospective analysis of international asymptomatic travellers entering Alberta, Canada. INTERVENTIONS: All participants were required to receive a PCR COVID-19 test on arrival. If negative, participants could leave quarantine but were required to have a second test 6 or 7 days after arrival. If the arrival test was positive, participants were required to remain in quarantine for 14 days. MAIN OUTCOME MEASURES: Proportion and rate of participants testing positive for COVID-19; number of cases of secondary transmission. RESULTS: The analysis included 9535 international travellers entering Alberta by air (N=8398) or land (N=1137) that voluntarily enrolled in the Alberta Border Testing Pilot Programme (a subset of all travellers); most (83.1%) were Canadian citizens. Among the 9310 participants who received at least one test, 200 (21.5 per 1000, 95% CI 18.6 to 24.6) tested positive. Sixty-nine per cent (138/200) of positive tests were detected on arrival (14.8 per 1000 travellers, 95% CI 12.5 to 17.5). 62 cases (6.7 per 1000 travellers, 95% CI 5.1 to 8.5; 31.0% of positive cases) were identified among participants that had been released from quarantine following a negative test result on arrival. Of 192 participants who developed symptoms, 51 (26.6%) tested positive after arrival. Among participants with positive tests, four (2.0%) were hospitalised for COVID-19; none required critical care or died. Contact tracing among participants who tested positive identified 200 contacts; of 88 contacts tested, 22 were cases of secondary transmission (14 from those testing positive on arrival and 8 from those testing positive thereafter). SARS-CoV-2 B.1.1.7 lineage was not detected in any of the 200 positive cases. CONCLUSIONS: 21.5 per 1000 international travellers tested positive for COVID-19. Most (69%) tested positive on arrival and 31% tested positive during follow-up. These findings suggest the need for ongoing vigilance in travellers testing negative on arrival and highlight the value of follow-up testing and contact tracing to monitor and limit secondary transmission where possible.

Living Kidney Donors' Financial Expenses and Mental Health.

BACKGROUND: Living kidney donors incur donation-related expenses, but how these expenses impact postdonation mental health is unknown. METHODS: In this prospective cohort study, the association between mental health and donor-incurred expenses (both out-of-pocket costs and lost wages) was examined in 821 people who donated a kidney at one of the 12 transplant centers in Canada between 2009 and 2014. Mental health was measured by the RAND Short Form-36 Health Survey along with Beck Anxiety Inventory and Beck Depression Inventory. RESULTS: A total of 209 donors (25%) reported expenses of >5500 Canadian dollars. Compared with donors who incurred lower expenses, those who incurred higher expenses demonstrated significantly worse mental health-related quality of life 3 months after donation, with a trend towards worse anxiety and depression, after controlling for predonation mental health-related quality of life and other risk factors for psychological distress. Between-group differences for donors with lower and higher expenses on these measures were no longer significant 12 months after donation. CONCLUSIONS: Living kidney donor transplant programs should ensure that adequate psychosocial support is available to all donors who need it, based on known and unknown risk factors. Efforts to minimize donor-incurred expenses and to better support the mental well-being of donors need to continue. Further research is needed to investigate the effect of donor reimbursement programs, which mitigate donor expenses, on postdonation mental health.

A RAND-Modified Delphi on Key Indicators to Measure the Efficiency of Living Kidney Donor Candidate Evaluations.

BACKGROUND AND OBJECTIVES: Many patients, providers, and potential living donors perceive the living kidney donor evaluation process to be lengthy and difficult to navigate. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We sought consensus on key terms and process and outcome indicators that can be used to measure how efficiently a transplant center evaluates persons interested in becoming a living kidney donor. Using a RAND-modified Delphi method, 77 participants (kidney transplant recipients or recipient candidates, living kidney donors or donor candidates, health care providers, and health care administrators) completed an online survey to define the terms and indicators. The definitions were then further refined during an in-person meeting with ten stakeholders. RESULTS: We identified 16 process indicators (e.g., average time to evaluate a donor candidate), eight outcome indicators (e.g., annual number of preemptive living kidney donor transplants), and two measures that can be considered both process and outcome indicators (e.g., average number of times a candidate visited the transplant center for the evaluation). Transplant centers wishing to implement this set of indicators will require 22 unique data elements, all of which are either readily available or easily collected prospectively. CONCLUSIONS: We identified a set of indicators through a consensus-based approach that may be used to monitor and improve the performance of a transplant center in how efficiently it evaluates persons interested in becoming a living kidney donor.

Evaluating multiple living kidney donor candidates simultaneously is more cost-effective than sequentially.

When multiple living donor candidates come forward to donate a kidney to the same recipient, some living donor programs evaluate one candidate at a time to avoid unnecessary evaluations. Evaluating multiple candidates concurrently rather than sequentially may be cost-effective from a societal perspective if it reduces the time recipients spend on dialysis. We used a simple decision tree to estimate the cost-effectiveness of evaluating two to four candidates simultaneously rather than sequentially as potential kidney donors for the same intended recipient. Evaluating two donor candidates simultaneously cost $1,266 (CAD) more than if they were evaluated sequentially, but living donation occurred one month earlier. This translated into $6,931 in averted dialysis costs and a total cost-savings of $5,665 per intended recipient. Simultaneous evaluations also resulted in one percent more living donor transplants and overall gains in quality-of-life as recipients spent less time on dialysis. If recipients were free from dialysis at the start of donor candidate evaluations, simultaneous evaluations also reduced the rate of dialysis initiation by two percent. Benefits were also observed in the three- and four-candidate scenarios. Thus, living donor programs should consider evaluating up to four living donor candidates simultaneously when they come forward for the same recipient as health care system costs incurred are more than offset by avoided dialysis costs.

Global case studies for chronic kidney disease/end-stage kidney disease care.

The prevalence of chronic kidney disease and its risk factors is increasing worldwide, and the rapid rise in global need for end-stage kidney disease care is a major challenge for health systems, particularly in low- and middle-income countries. Countries are responding to the challenge of end-stage kidney disease in different ways, with variable provision of the components of a kidney care strategy, including effective prevention, detection, conservative care, kidney transplantation, and an appropriate mix of dialysis modalities. This collection of case studies is from 15 countries from around the world and offers valuable learning examples from a variety of contexts. The variability in approaches may be explained by country differences in burden of disease, available human or financial resources, income status, and cost structures. In addition, cultural considerations, political context, and competing interests from other stakeholders must be considered. Although the approaches taken have often varied substantially, a common theme is the potential benefits of multistakeholder engagement aimed at improving the availability and scope of integrated kidney care.

Nonreimbursed Costs Incurred by Living Kidney Donors: A Case Study From Ontario, Canada.

BACKGROUND: Living donors may incur out-of-pocket costs during the donation process. While many jurisdictions have programs to reimburse living kidney donors for expenses, few programs have been evaluated. METHODS: The Program for Reimbursing Expenses of Living Organ Donors was launched in the province of Ontario, Canada in 2008 and reimburses travel, parking, accommodation, meals, and loss of income; each category has a limit and the maximum total reimbursement is $5500 CAD. We conducted a case study to compare donors' incurred costs (out-of-pocket and lost income) with amounts reimbursed by Program for Reimbursing Expenses of Living Organ Donors. Donors with complete or partial cost data from a large prospective cohort study were linked to Ontario's reimbursement program to determine the gap between incurred and reimbursed costs (n = 159). RESULTS: The mean gap between costs incurred and costs reimbursed to the donors was $1313 CAD for out-of-pocket costs and $1802 CAD for lost income, representing a mean reimbursement gap of $3115 CAD. Nondirected donors had the highest mean loss for out-of-pocket costs ($2691 CAD) and kidney paired donors had the highest mean loss for lost income ($4084 CAD). There were no significant differences in the mean gap across exploratory subgroups. CONCLUSIONS: Reimbursement programs minimize some of the financial loss for living kidney donors. Opportunities remain to remove the financial burden of living kidney donors.

Mapping variation in intervention design: a systematic review to develop a program theory for patient navigator programs.

BACKGROUND: There is a great deal of variation in the design and delivery of patient navigator (PN) programs, making it difficult to design or adopt these interventions in new contexts. We (1) systematically reviewed the literature to generate a preliminary program theory to describe how patient navigator interventions are designed and delivered; and (2) describe how the resulting program theory was applied in context to inform a prototype for a patient navigator program. METHODS: The current study includes a secondary review of a larger systematic review. We reviewed studies included in the primary review to identify those that designed and evaluated programs to assist patients in accessing and/or adhering to care. We conducted a content analysis of included publications to describe the barriers targeted by PN interventions and the navigator activities addressing those barriers. A program theory was constructed by mapping patient navigator activities to corresponding constructs within the capability-opportunity-motivation model of behavior change (COM-B) model of behavior change. The program theory was then presented to individuals with chronic disease, healthcare providers, and system stakeholders, and refined iteratively based on feedback. RESULTS: Twenty one publications describing 19 patient navigator interventions were included. A total of 17 unique patient navigator activities were reported. The most common included providing education, facilitating referrals, providing social and emotional support, and supporting self-management. The majority of navigator activities targeted barriers to physical opportunity, including facilitating insurance claims, assistance with scheduling, and providing transportation. Across all interventions, navigator activities were designed to target a total of 20 patient barriers. Among interventions reporting positive effects, over two thirds targeted knowledge barriers, problems with scheduling, proactive re-scheduling following a missed appointment, and insurance. The final program design included a total of 13 navigator activities-10 informed by the original program theory and 3 unique activities informed by stakeholders. CONCLUSIONS: There is considerable heterogeneity in intervention content across patient navigator interventions. Our results provide a schema from which to develop PN interventions and illustrate how an evidence-based model was used to develop a real-world PN intervention. Our findings also highlight a critical need to improve the reporting of intervention components to facilitate translation. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42013005857.

Financial Costs Incurred by Living Kidney Donors: A Prospective Cohort Study.

BACKGROUND: Approximately 40% of the kidneys for transplant worldwide come from living donors. Despite advantages of living donor transplants, rates have stagnated in recent years. One possible barrier may be costs related to the transplant process that potential willing donors may incur for travel, parking, accommodation, and lost productivity. METHODS: To better understand and quantify the financial costs incurred by living kidney donors, we conducted a prospective cohort study, recruiting 912 living kidney donors from 12 transplant centers across Canada between 2009 and 2014; 821 of them completed all or a portion of the costing survey. We report microcosted total, out-of-pocket, and lost productivity costs (in 2016 Canadian dollars) for living kidney donors from donor evaluation start to 3 months after donation. We examined costs according to (1) the donor's relationship with their recipient, including spousal (donation to a partner), emotionally related nonspousal (friend, step-parent, in law), or genetically related; and (2) donation type (directed, paired kidney, or nondirected). RESULTS: Living kidney donors incurred a median (75th percentile) of $1254 ($2589) in out-of-pocket costs and $0 ($1908) in lost productivity costs. On average, total costs were $2226 higher in spousal compared with emotionally related nonspousal donors (P=0.02) and $1664 higher in directed donors compared with nondirected donors (P<0.001). Total costs (out-of-pocket and lost productivity) exceeded $5500 for 205 (25%) donors. CONCLUSIONS: Our results can be used to inform strategies to minimize the financial burden of living donation, which may help improve the donation experience and increase the number of living donor kidney transplants.

Healthcare Costs for the Evaluation, Surgery, and Follow-Up Care of Living Kidney Donors.

BACKGROUND: The healthcare costs to evaluate, perform surgery, and follow a living kidney donor for the year after donation are poorly described. METHODS: We obtained information on the healthcare costs of 1099 living kidney donors between April 1, 2004, and March 31, 2014, from Ontario, Canada, using comprehensive healthcare administrative databases. We estimated the cost of 3 periods of the living donation process: the predonation evaluation period (start of evaluation until the day before donation), perioperative period (day of donation until 30-days postdonation), and 1 year of follow-up period (after perioperative period until 1 year postdonation). We analyzed data for donors and healthy matched nondonor controls using regression-based methods to estimate the incremental cost of living donation. Costs are presented from the perspective of the Canadian healthcare payer (2017 CAD $). RESULTS: The incremental healthcare costs (compared with controls) for the evaluation, perioperative, and follow-up periods were CAD $3596 (95% confidence interval [CI], CAD $3350-$3842), CAD $11 694 (95% CI, CAD $11 415-CAD $11 973), and $1011 (95% CI, CAD $793-CAD $1230), respectively, totalling CAD $16 290 (95% CI, CAD $15 814-CAD $16 767). The evaluation cost was higher if the intended recipient started dialysis partway through the donor evaluation (CAD $886; 95% CI, CAD $19, CAD $1752). The perioperative cost varied across transplant centers (P < 0.0001). CONCLUSIONS: Although substantial costs of living donor care are related to the nephrectomy procedure, comprehensive assessment of costs must also include the evaluation and follow-up periods. These estimates are informative for planning future work to support and expand living donation and transplantation, and directing efforts to improve the cost efficiency of living donor care.

Patient navigators for people with chronic disease: A systematic review.

BACKGROUND: People with chronic diseases experience barriers to managing their diseases and accessing available health services. Patient navigator programs are increasingly being used to help people with chronic diseases navigate and access health services. OBJECTIVE: The objective of this review was to summarize the evidence for patient navigator programs in people with a broad range of chronic diseases, compared to usual care. METHODS: We searched MEDLINE, EMBASE, CENTRAL, CINAHL, PsycINFO, and Social Work Abstracts from inception to August 23, 2017. We also searched the reference lists of included articles. We included original reports of randomized controlled trials of patient navigator programs compared to usual care for adult and pediatric patients with any one of a defined set of chronic diseases. RESULTS: From a total of 14,672 abstracts, 67 unique studies fit our inclusion criteria. Of these, 44 were in cancer, 8 in diabetes, 7 in HIV/AIDS, 4 in cardiovascular disease, 2 in chronic kidney disease, 1 in dementia and 1 in patients with more than one condition. Program characteristics varied considerably. Primary outcomes were most commonly process measures, and 45 of 67 studies reported a statistically significant improvement in the primary outcome. CONCLUSION: Our findings indicate that patient navigator programs improve processes of care, although few studies assessed patient experience, clinical outcomes or costs. The inability to definitively outline successful components remains a key uncertainty in the use of patient navigator programs across chronic diseases. Given the increasing popularity of patient navigators, future studies should use a consistent definition for patient navigation and determine which elements of this intervention are most likely to lead to improved outcomes. TRIAL REGISTRATION: PROSPERO #CRD42013005857.

Direct and indirect costs incurred by Australian living kidney donors.

AIM: To describe the direct and indirect costs incurred by Australian living kidney donors. METHODS: A total of 55 living kidney donors from three centres in Perth, Australia and one centre in Melbourne, Australia (2010-2014) was studied. Forty-nine donors provided information on expenses incurred during the donor evaluation period and up to 3 months after donation. A micro-costing approach was used to measure and value the units of resources consumed. Expenses were grouped as direct costs (ground and air travel, accommodation, and prescription medications) and indirect costs (lost wages and lost productivity). Costs were standardized to the year 2016 in Australian dollars. RESULTS: The most common direct costs were for ground travel (100%), parking (76%), and post-donation pain medications or antibiotics (73%). The highest direct costs were for air travel (median $1986 [three donors]) and ground travel (median $459 [49 donors]). Donors also reported lost wages (median $9891 [37 donors]). The inability to perform household activities or care for dependants were reported by 32 (65%) and 23 (47%) donors. Total direct costs averaged $1682 per donor (median $806 among 49 donors). Total indirect costs averaged $7249 per donor (median $7273 among 49 donors). Total direct and indirect costs averaged $8932 per donor (median $7963 among 49 donors). CONCLUSION: Many Australian living kidney donors incur substantial costs during the donation process. Our findings inform the continued development of policies and programmes designed to minimize costs incurred by living kidney donors.