Archives of Medical Research 44 (2013) 655e661

ORIGINAL ARTICLE

Comparison of Cost-Utility Between Automated Peritoneal Dialysis and Continuous Ambulatory Peritoneal Dialysis Laura Cortes-Sanabria,a Carlos A. Paredes-Cese~ na,a Rebeca M. Herrera-Llamas,a Yolanda Cruz-Bueno,b c d Herman Soto-Molina, Leonardo Pazarın, Margarita Cortes,e and Hector R. Martınez-Ramıreza a

Medical Research Unit in Kidney Diseases, Specialties Hospital, CMNO, Instituto Mexicano del Seguro Social (IMSS), Guadalajara, Mexico b Department of Social Work, Regional Hospital No. 110, IMSS, Guadalajara, Mexico c Departament of Pharmacology, Universidad Autonoma Metropolitana, Mexico, D.F., Mexico d Hemodialysis Unit, HGR No. 46, Guadalajara, Mexico e Peritoneal Dialysis Unit, General Zone Hospital No. 14, IMSS, Guadalajara, Mexico Received for publication August 22, 2013; accepted October 22, 2013 (ARCMED-D-13-00462).

Background and Aims. The use of automated peritoneal dialysis (APD) is increasing compared to continuous ambulatory peritoneal dialysis (CAPD). Surprisingly, little data about health benefits and cost of APD exist, and virtually no information comparing the cost-utility between CAPD and APD is available. We undertook this study to evaluate and compare the health-related quality of life (HRQOL) and cost-utility indexes in patients on CAPD vs. APD. Methods. This was a prospective cohort of patients initiating dialysis (2008e2009). Two questionnaires were self-administered: European Research Questionnaire Quality of Life (EQ-5D) and Kidney Disease Quality of Life (short form, KDQOL-SF, Rand, Santa Monica, CA). Direct medical costs (DMC) were determined from the health provider perspective including the following medical resource utilization: outpatient clinic/ emergency care, dialysis procedures, medications, laboratory tests, hospitalization, and surgery. Cost-utility indexes were calculated dividing total mean cost by indicators of the HRQOL. Results. One hundred twenty-three patients were evaluated: 77 on CAPD and 46 on APD. Results of the EQ-5D and KDQOL-SF questionnaires were significantly better in APD compared to the CAPD group. Main costs in both APD and CAPD were attributed to hospitalization and dialysis procedures followed by medication and surgery. Outpatient clinic visits and laboratory tests were significantly more costly in CAPD than in APD, whereas dialysis procedures were more expensive in the latter. Cost-utility indexes were significantly better in APD compared to CAPD. Conclusions. A significant cost-utility advantage of APD vs. CAPD was observed. The annual DMC per-patient were not different between groups but the HRQOL was better in the APD compared to the CAPD group. Ó 2013 IMSS. Published by Elsevier Inc. Key Words: Direct medical costs, Cost-utility index, Utilities, Quality of life, Continuous ambulatory peritoneal dialysis, Automated peritoneal dialysis.

Introduction

Address reprint requests to: Dr. Laura Cortes-Sanabria, Unidad de Investigaci on Medica en Enfermedades Renales, Hospital de Especialidades, CMNO, IMSS, Belisario Domınguez No. 1000, Col. Independencia, Guadalajara, Mexico; Phone: (þ52) (33) 3668-3000 ext. 32204; FAX: (þ52) (33) 3624-5000; E-mail: [email protected]

During the last decades the incidence and prevalence of end-stage renal disease (ESRD) has impressively increased in Mexico (1) and is expected to double every 8e10 years (2). The important increase in prevalence of diabetes mellitus, hypertension, obesity and other causes of ESRD will worsen this picture (3).

0188-4409/$ - see front matter. Copyright Ó 2013 IMSS. Published by Elsevier Inc. http://dx.doi.org/10.1016/j.arcmed.2013.10.017

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The increase in the number of ESRD-treated patients is associated with markedly higher utilization of resources and costs. In the U.S., for example, the cost of ESRD treatment was 32.9 billion dollars in 2010 (1). In Mexico, health care is provided by different systems: The Mexican Institute of Social Security (IMSS) is the major health provider covering approximately 40% of the total population (43 million persons) (4); approximately 80% of patients on renal replacement therapy are covered by the IMSS (5). In the IMSS, ESRD is the third most costly disease only after diabetes and hypertension: it consumes about USD 917 million/year (representing 16% of the main budget) expended in only 1.4% of the insured population with ESRD (2). In Mexico, more than half of ESRD patients are currently treated with peritoneal dialysis (PD) (1). Of these, 40% are on automated peritoneal dialysis (APD) and 60% on continuous ambulatory peritoneal dialysis (CAPD). Since its local introduction in 1998, APD has been growing at an annual rate of |10% (5). From the clinical point of view, APD and CAPD have similar results (1,6,7) [with certain APD advantage in some cases (8,9)]. In spite of the improvements in ESRD treatment, the health-related quality of life (HRQOL, Rand, Santa Monica, CA) is much lower in these patients than for the general population (10,11). The assessment of HRQOL can help to identify ways to improve the well-being of ESRD patients and potentially to identify strategies to prevent adverse outcomes (12,13). Many papers reporting HRQOL in PD have been published (14e16); however, it is surprising that little data on APD exist, and virtually no information on the comparison of cost-utility between CAPD and APD is available. Health economics evaluations frequently consider only direct medical costs (DMC), which are those generated by the medical intervention per se; however, they do not consider other benefits useful for the patient on PD as HRQOL. A more complete vision may be obtained by including both variables: cost and utility (17). From the point of view of health administrators and decision takers, it is imperative to identify both quality of life (QOL) and cost indicators to meet the projected increasing of ESRD demand and the best QOL. We have recently shown that DMC between CAPD and APD are not significantly different (18). However, the balance between additional health benefits for each modality of PD was not assessed. Therefore, the present study was designed to evaluate and compare the HRQOL and costutility indexes in patients on CAPD vs. APD. Patients and Methods A cohort of adult patients initiating PD between January 2008 and December 2009 in two General Hospitals (Hospital General de Zona No. 14 and Hospital General Regional No. 110), IMSS, Guadalajara, was prospectively analyzed. Patients were excluded if they had cancer, AIDS, mental

disability or advanced heart or liver disease. Subjects were randomly selected (by a computer-generated randomization list) from a total of 434 and 94 patients initiating CAPD or APD, respectively, during the study period. All patients had a 1-year follow-up. Measurement of Health-related Quality of Life Two generic questionnaires were employed to measure QOL: The European Research Questionnaire Quality of Life (EuroQol, EQ-5D) (19) and the Kidney Disease Quality of Life (KDQOL, short form, v.1.3, KDQOL-SF) (20). Both questionnaires have been validated in a Mexican population (21,22), and were self-administered to all patients after they accepted to participate. EQ-5D The EQ-5D is a validated generic questionnaire including a classification system (EQ-5D profile) and a visual analogue scale (EQVAS) (19,23). The EQ-5D profile records the level of self-assessed problems in five domains of health (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each with 3 levels: 1 5 no problems; 2 5 some problems; 3 5 unable to perform/extreme problems. An EQ-5D score of 1.0 represents perfect health and 0 death. The second part of the EQ-5D is a visual analogue scale (VAS). For the EQVAS, patients were presented with a vertical line with end points of ‘‘worst imaginable health’’ at 0 and ‘‘best imaginable health’’ at 100. The respondents were asked to mark the point on the scale that corresponded to the rating of their current health status. The VAS score was obtained by dividing the number marked on the scale by 100, which is between 0 and 1.0. KDQOL-SF The KDQOL combines the generic SF-36 with a kidney disease-specific instrument (20). The SF-36 instrument measures eight domains of functioning and well-being on a 100-point scale (the higher the scale the better the patient’s HRQOL): a) physical functioning, b) role limitations caused by physical problems, c) pain, d) general health, e) energy/fatigue, f) emotional well-being, g) role limitations caused by emotional problems, and h) social function. Results from the SF-36 instrument are further summarized into a physical composite summary (PCS) score and a mental composite summary (MCS) score using the RAND scoring algorithm (20). The PCS aggregates items from physical functioning, role-physical, bodily pain, general health, vitality, and social functioning. The MCS aggregates items from role-emotional, mental health, and includes elements of general health, vitality, and social functioning. In the general population, the mean for each summary scale is 50 points, with a standard deviation of 10 points.

Cost-Utility Index in Peritoneal Dialysis

The disease-specific component of the KDQOL measures 11 domains (on a 100-point scale) related to kidney disease (24): a) burden of kidney disease, b) cognitive function, c) dialysis staff encouragement, d) effects of kidney disease, e) patient satisfaction, f) quality of social interaction, g) sexual function, h) sleep, i) social support, j) symptom problem, and k) work status. A kidney disease component summary (KDCS) score, also on a 100-point scale, was computed according to Mapes et al. (12). Data Collection for Calculation of Direct Medical Costs Only DMC (all monetary costs in which the provider, the IMSS, incurred in generating the medical attention for each PD program) were considered. DMC included the major components of medical resource utilization: outpatient clinic visits, emergency room visits, dialysis procedures, medication, laboratory tests, hospitalization, and surgery. To calculate cost of resources, estimation of all the components and data of clinical variables and resource utilization were obtained from medical charts. A data collection sheet was previously designed and validated by health economic experts (HSM) and was applied in all cases. For costs calculation, the official cost list for drugs and medical materials published by the IMSS and the cost list for medical services and laboratory/image tests (Institutional Unit Cost System 2008e2010, published in the Official Federation Bulletins) were used (25e27). Costs were also updated to 2012, considering the costs in the official list of 2012 (28); a discount rate of 3% was applied. All costs were converted into U.S. dollars (USD) at the 2012 exchange rate (1 USD 5 13.18 Mexican pesos). The total annual average cost and the per-person annual resource utilization were determined for each modality of dialysis. Definitions Outpatient clinic visits. This included salary of the nephrology team or other specialties. Emergency room visits. This included data from the salary of the health team, laboratory and imaging studies, and medication.

657

drugs, laboratory and imaging tests carried out during hospitalization. Surgery. Only surgical procedures related to PD and its complications, as well as the cost of the operating room, were considered. Utility. This is the benefit or preferences that a person receives from the consumption of goods or services (in this case, the dialysis modality). Sometimes it is also referred to as ‘‘value,’’ ‘‘preference score,’’ or ‘‘quality of life weight.’’ Statistical Analysis Data are shown as mean  SD and 95% confidence interval (CI), median (percentiles 25e75%) or percentages, as appropriate. Comparison between groups was done using Student t test in case of continuous variables. Where the distribution of scores deviated from normality, MannWhitney U test was used. Categorical variables were compared using c2 test. Cost-Utility Analysis In comparing health utilization between groups, the total mean cost by type of dialysis was estimated. Bootstrap analysis (1,000 replications) was employed to describe the uncertainty in estimation of mean cost for each group. In this study, we used ‘‘utility’’ as quality of life weight. Utilities were assigned using a utility-weighted health status index by means of EuroQoL and KDQOL-SF (29). Utility is measured on a 0e1 scale where 0 represents death and 1 represents full health. The cost-utility indexes were calculated dividing total mean cost by the indicators of HRQOL. In the current study, when using the HRQOL indicator, estimations of differences between groups did not include quality-adjusted life years (QALYs) as we performed only one measurement of QOL (at the end of follow-up). All statistical analyses were carried out using SPSS v.18; p value !0.05 was considered significant. Results

Dialysis procedures. This included data from dialysis catheters, solutions and sets, gloves, masks, antiseptics, adhesive medical tape, and gauze. Medications. Only drugs used in the ambulatory care of PD patients were considered. Laboratory tests. These included all laboratory and imaging tests performed in the ambulatory care of PD patients. Hospitalization costs. This included frequency, days of hospitalization, hospital room cost, health team salary,

Characteristics of CAPD and APD Patients One hundred twenty-three patients were evaluated: 77 on CAPD and 46 on APD. Comparison of sociodemographic characteristic is shown in Table 1. Patients in APD were younger and had a higher educational level compared to those in CAPD; they also more frequently receive income from employment than the other patients. Diabetes mellitus, as a cause of ESRD, tended to be observed more frequently in the CAPD group. No significant differences with respect to gender, marital status, primary caregiver and dialysis vintage were found between groups.

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Cortes-Sanabria et al./ Archives of Medical Research 44 (2013) 655e661

Table 1. Comparison of characteristics according to type of dialysis Characteristic

CAPD

APD

Table 2. Comparison of EQ-5D domains, EQ-5D score, and VAS score between groups

p Domain

Number of patients Age, (years) Female, n (%) Married/living together, n (%) Educational level, n (%) #6 years O6 to #9 years O9 years Employment status, n (%) Working full/part time Unemployed At home Retired Student Source of income, n (%) Employee income Mixed Dependent Primary caregiver, n (%) Cause of ESRD, n (%) Diabetes mellitus Unknown Hypertension Other Months on dialysis

77 53  16 42 (54) 54 (70)

46 42  18 21 (46) 26 (56)

43 (56) 22 (28) 12 (16)

16 (35) 12 (26) 18 (39)

12 27 22 15 1

(16) (35) (29) (19) (1)

26 5 10 4 2

(56) (11) (22) (9) (2)

14 7 56 68

(18) (9) (73) (88)

22 4 20 40

(48) (9) (43) (87)

54 11 7 5 18

(70) (14) (9) (7) (9e31)

22 15 3 6 18

(48) (33) (6) (13) (12e25)

0.001 0.35 0.17 0.01

!0.0001

0.002

0.86 0.06

0.61

CAPD, continuous ambulatory peritoneal dialysis; APD, automated peritoneal dialysis; ESRD, end-stage renal disease.

Results of Quality of Life QOL, as measured by the EQ-5D questionnaire (Table 2), was significantly better in APD patients in two out of five domains: self-care and usual activities. Similarly, APD patients displayed better results in EQ-5D and VAS scores. KDQOL-SF MCS and PCS, as well as KDCS, were significantly better in the APD compared to the CAPD group (Table 3). Results of Cost Analysis In general, a total USD $1,739,532 were expended in these 123 PD patients during 1-year of follow-up, with most of the costs due to hospitalization (USD 612,205) followed by dialysis-related procedures (USD 580,475), medication (USD 268,142) and surgical expenses (USD 189,321). The least expensive procedures were outpatient and emergency visits (USD 45,689 and USD 27,526, respectively), and laboratory tests (USD 16,171). Table 4 shows the comparison of annual per-person DMC of resource utilization between CAPD and APD patients. Outpatient clinic visits and laboratory tests were significantly more costly in CAPD than in APD patients, whereas dialysis procedures were significantly more costly in the latter. Other resources and the total DMC were not significantly different between groups. Main costs in both APD and CAPD patients were attributed to hospitalization and dialysis procedures followed by medication and surgery.

CAPD

APD

p

EQ-5D domains Mobility, n (%) No problem walking 26 (34) 23 (50) Some problem walking 42 (54) 20 (44) Confined to bed 9 (12) 3 (6) Self-care, n (%) No problem 47 (61) 39 (85) Some problems washing 16 (21) 4 (9) or dressing Unable to wash or dress 14 (18) 3 (6) Usual activities,a n (%) No problem 33 (43) 28 (61) Some problems 25 (32) 15 (33) Unable to perform 19 (25) 3 (6) Pain/discomfort, n (%) No pain or discomfort 34 (44) 27 (59) Moderate 33 (43) 13 (28) Extreme 10 (13) 6 (13) Anxiety/depression, n (%) Not anxious or 27 (35) 24 (52) depressed Moderate 27 (35) 13 (28) Extreme 23 (30) 9 (20) EQ-5D score 0.51 (0.41e0.61) 0.67 (0.54e0.78) VAS score 0.60 (0.55e0.65) 0.68 (0.62e0.74)

0.18

0.02

0.02

0.23

0.16

0.04 0.02

EQ-5D, EuroQol five-dimensional questionnaire; VAS, visual analogue scale. a e.g., work, study, housework, family or leisure activities.

Annual Global Costs and Cost-Utility Indexes The annual total per-patient cost for APD was USD 13,999 and USD 14,247 for CAPD. The utility indexes, as well as their differences, calculated by means of EuroQoL and KDQOL-SF were better in APD in comparison with CAPD (Table 5).

Discussion The influence of economic variables on the design of clinical management guidelines and health policy decisions, with the view of optimizing limited healthcare monetary resources, is increasing (17,30). This is particularly true in ESRD due to the increase of this public health problem and the extraordinary high cost of its treatment (1,2). Table 3. Comparison of HRQOL measured by KDQOL-SF questionnaire, between groups Dimensions KDQOL, mean (95% CI) Kidney disease component summary SF-36, mean (95% CI) Mental component summary Physical component summary

CAPD

APD

p

53 (51e55)

66 (63e69)

!0.0001

53 (47e59) 41 (37e45)

77 (73e81) 62 (56e67)

!0.0001 !0.0001

Cost-Utility Index in Peritoneal Dialysis

659

Table 4. Comparison of annual per-person direct medical costs (USD) of resource utilization between groups Annual per-patient cost [mean (95% CI)] Type of resource Outpatient clinic visits Emergency room visits Dialysis procedures Medication Laboratory tests Hospitalization Surgery Total

CAPD 410 227 4,270 2,268 144 5,325 1,602 14,247

(365e453) (189e268) (3,886e4,565) (2,036e2,535) (126e162) (4,466e6,349) (1,471e1,738) (13,284e15,504)

% 2.9 1.6 30 16 1.0 37.3 11.2

APD 306 217 5,471 2,032 109 4,395 1,433 13,966

(252e369) (155e277) (5,062e5,874) (1,719e2,346) (83e139) (3,795e5,124) (1,306e1580) (13,118e14,982)

%

p

2 1.5 39 14.5 0.7 30.1 12.2

0.004 0.79 !0.0001 0.26 0.04 0.10 0.12 0.80

USD, US dollar; CI, confidence interval; CAPD, continuous ambulatory peritoneal dialysis; APD, automated peritoneal dialysis.

As APD is constantly increasing its use compared to CAPD, it is necessary to evaluate its additional health benefits compared to CAPD and the associated cost (17). In our study, costs were not significantly different between groups and patients on APD have higher utility in HRQOL than patients on CAPD. Studies comparing HRQOL between APD and CAPD are scarce, and results are controversial; most showed no differences between therapies (6,7,31e34). In contrast, in our study HRQOL of APD patients was better regarding selfcare, usual activities, EQ-5D score, VAS score, MCS and PCS compared with CAPD patients. Ayounger age and higher educational level, as well as the fact of having an employee income may have had an influence on the results. In fact, these factors are eligibility criteria for APD in our setting (as in many others). In both PD therapies, however, results of HRQOL were notably below the levels of the general population, which has been previously reported (6,7,31e34). On the other hand, our results confirmed a higher cost for the APD dialysis procedure compared to CAPD, and the total costs were not notably different from a previous study in our setting (18). Except for the dialysis procedures, the cost of all the other resource utilizations were significant or tended to be higher in CAPD that in APD, which equilibrated the total cost between therapies. Comparing

only costs between our results and others (35e39) is difficult because of differences in methods for collecting data and evaluation techniques, analyzed resources, time of investigation and cost of living in different locations. To the best of our knowledge, ours is the first study comparing CAPD vs. APD in terms of cost-utility. In this regard, comparing hemodialysis and PD, the cost per life year and cost per QALYs are more favorable for the latter in some studies (40) but not in others (41). Arredondo et al. (42) performed a study of cost-effectiveness of interventions in ESRD in Mexican patients and concluded that the highest cost-effectiveness intervention was renal transplant followed by CAPD and HD. Strengths shown in the present study include the estimation of utility from a cohort of PD patients according to the type of dialysis (CAPD vs. APD) using a generic instrument (EQ-5D) and the comparison of the utility estimates with a questionnaire combining the generic instrument with a kidney disease-specific instrument (KDQOL-SF36). The similar cost utility indexes produced by each of these methods provide further strength to the study. The use of alternative scoring methods might be useful to avoid the discrepancies argued against the EQ-5D (43). The incomparability of results of costeutility analyses using different instruments to estimate a single index value for health

Table 5. Comparison of cost analysis indexes between groups Instrument EQ-5D

KDQOL

SF-36

HRQL indicator

CAPD

APD

EQ-5D score Annual total cost Cost/utility index (95% CI) VAS score Annual total cost Cost/utility index (95% CI) Kidney disease component summary Annual total cost Cost/utility index (95% CI) Mental component summary Annual total cost Cost/utility index (95% CI) Physical component summary Annual total cost Cost/utility index (95% CI)

51 14,247 241 (108e380) 60 14,247 281 (243e334) 53 14,247 278 (252e306) 53 14,247 359 (309e414) 41 14,247 427 (188e291)

67 13,966 135 (109e250) 68 13,966 234 (196e282) 66 13,966 215 (199e233) 77 13,966 187 (171e204) 62 13,966 257 (219e299)

p

0.06

0.04

!0.0001 !0.0001 !0.0001

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Cortes-Sanabria et al./ Archives of Medical Research 44 (2013) 655e661

would severely undermine this aspect and reduce the credibility of the use of incremental costeutility ratios for decision-making (44). Limitations of our study include that the treatment assignment was not randomized, calculation of only costutility indexes, and the measurement of HRQOL only on one occasion (end of the follow-up). To assess a more precise economic impact, it would be necessary to calculate the QALYs with several measurements in a longitudinal study or to perform an economic modeling study. In developing countries, a variety of factors need to be considered in addressing the QOL. Sometimes the patient and his/her family have to assume the financial burden of care, which may come at the expense of other family necessities such as the care of other family members, education or nutrition (45). The impact of these financial stressors on the QOL in patients with ESRD needs to be evaluated in economic evaluation studies. Future studies with longer follow-up and larger sample size would do well to use complete economic evaluation and calculate the QALYs to assess a greater economic impact on the health benefits of PD patients. Moreover, further research is necessary to determine the effects of interventions directed to enhance the emotional and social support. In conclusion, a significant cost-utility advantage of APD vs. CAPD was observed. The annual DMCs perpatient were not different between groups but the HRQOL was better in the APD compared to the CAPD group. References 1. The United States Renal Data System (USRDS): http://www.usrds.org (accessed June 2, 2013). 2. Informe al Ejecutivo Federal y al Congreso de la Union sobre la situaci on financiera y los riesgos del Instituto Mexicano del Seguro Social 2012e2013. Available at: http://www.imss.gob.mx/estadisticas/ Documents/20122013/c02.pdf (accessed June 2, 2013). 3. Gutierrez JP, Rivera-Dommarco J, Shamah-Levy T, et al. Encuesta Nacional de Salud y Nutricion 2012. Resultados Nacionales. Cuernavaca, Mexico: Instituto Nacional de Salud Publica (MX); 2012. Available at: http://ensanut.insp.mx/informes/ ENSANUT2012ResultadosNacionales.pdf. (accessed June 2, 2013). 4. Instituto Nacional de Geografıa y Estadıstica. http://inegi.org.mx (accessed July 12, 2013). 5. Cueto-Manzano AM, Rojas-Campos E. Status of renal replacement therapy and peritoneal dialysis in Mexico. Perit Dial Int 2007;27:142e148. 6. Rabindranath KS, Adams J, Ali TZ, et al. Automated vs continuous ambulatory peritoneal dialysis: a systematic review of randomized controlled trials. Nephrol Dial Transplant 2007;22:2991e2998. 7. Badve SV, Hawley CM, McDonald SP, et al. Automated and continuous ambulatory peritoneal dialysis have similar outcomes. Kidney Int 2008;73:480e488. 8. Mujais S, Story K. Peritoneal dialysis in the U.S.: evaluation of outcomes in contemporary cohorts. Kidney Int 2006;70(suppl 103):S21eS26. 9. Sanchez AR, Madonia C, Rascon-Pacheco RA. Improved patient/technique survival and peritonitis rates in patients treated with automated peritoneal dialysis when compared to continuous ambulatory peritoneal dialysis in a Mexican PD center. Kidney Int 2008;73(suppl 108):S76eS80.

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Comparison of cost-utility between automated peritoneal dialysis and continuous ambulatory peritoneal dialysis.

The use of automated peritoneal dialysis (APD) is increasing compared to continuous ambulatory peritoneal dialysis (CAPD). Surprisingly, little data a...
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