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American Journal of Critical Care. 2007;16: 222-235
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CE Article

Prevalence and Consequences of Nonadherence to Hemodialysis Regimens

By Kris Denhaerynck, RN, PhD, Dominique Manhaeve, MNS, Fabienne Dobbels, PhD, Daniela Garzoni, MD, Christa Nolte, RN and Sabina De Geest, RN, PhD. Kris Denhaerynck is a postdoctoral fellow and Sabina De Geest is a professor of nursing with the Institute of Nursing Science, University of Basel, Basel, Switzerland. Dominique Manhaeve is a clinical trial leader with Tibotec BVBA, Mechelen, Belgium. Fabienne Dobbels is a postdoctoral fellow at the Center for Health Services and Nursing Research, School of Public Health, Katholieke Universiteit Leuven, Leuven, Belgium. Daniela Garzoni and Christa Nolte are an attending physician and a study nurse from the Department of Transplant Immunology and Nephrology, University Hospital Basel, Basel, Switzerland.

Corresponding author: Sabina De Geest, RN, PhD, Institute of Nursing Science, University of Basel, Bernoullistrasse 28, CH-4056 Basel, Switzerland (e-mail: sabina.degeest{at}unibas.ch).


   Abstract
Top
 Abstract
Prevalence of Nonadherence
 Consequences of Nonadherence
 Conclusion
 References
 
Adherence to fluid restrictions and dietary and medication guidelines as well as attendance at prescribed hemodialysis sessions of a hemodialysis regimen are essential for adequate management of end-stage renal disease. A literature review was conducted to determine the prevalence and consequences of nonadherence to the different aspects of a hemodialysis regimen and the methodological obstacles in research on nonadherence. Nonadherence to the prescribed regimen is a common problem in hemodialysis and is associated with increased morbidity and mortality. Research on nonadherence is associated with 2 major obstacles: inconsistencies in definitions and invalid measurement methods. Further research is needed to validate measurement methods and to establish clinically relevant operational definitions of nonadherence.

Notice to CE enrollees:
A closed-book, multiple-choice examination following this article tests your understanding of the following objectives:
  1. Compare the differences between interdialytic weight gain and intradialytic weight loss.
  2. Describe the consequences of nonadherence to hemodialysis regimens.
  3. Identify nursing strategies to assist patients with compliance and adherence to hemodialysis regimens.

To read this article and take the CE test online, visit www.ajcconline.org and click "CE Articles in This Issue."

According to registries in the United States and Europe, prevalence and incidence rates of end-stage renal disease are increasing. Currently, the prevalence is 479 to 1500 cases per million inhabitants and the incidence is 75 to 308 cases per million inhabitants, depending on the region studied.1,2 These numbers are generally higher among minority groups (eg, African Americans).2 During the past decade, the increase in the incidence rate has slowed in the United States, probably because of better management of the most important causes of renal failure: diabetes and hypertension.

End-stage renal disease can be treated by renal replacement therapies, such as hemodialysis, transplantation, and peritoneal dialysis. Hemodialysis is the therapy used most often. Among patients with end-stage renal disease, 66% in the United States and 46% to 98% in Europe receive hemodialysis.1,2 Although hemodialysis effectively contributes to long-term survival, morbidity and mortality of dialysis patients remains high, especially morbidity and mortality due to cardiovascular diseases.3–7 Only 32% to 33% of patients on hemodialysis survive to the fifth year of treatment, whereas 70% of patients who have kidney transplants are alive after 5 years.8

A hemodialysis regimen is based on 2 pillars: restriction of certain nutrients and removal of waste metabolites from the blood by regular dialysis. Central to effective management of patients with end-stage renal disease is adherence to this therapeutic regimen. Adherence refers to "the extent to which a person’s behavior—taking medication, following a diet, and/or executing lifestyle changes—corresponds [to] the agreed recommendations from a health care provider."9

Successful hemodialysis depends on 4 factors: fluid restriction, dietary guidelines, medication prescriptions, and attendance at hemodialysis sessions.10 Fluid restrictions can be as severe as a maximum 500 mL of fluid intake daily, depending on the residual diuresis. Patients receiving hemodialysis report a large preoccupation with thirst, rank fluid adherence as distressing,11 and often embark on fluid and dietary binges.12 Prescribed dietary restrictions limit sodium, potassium, and protein intake. The goals of the medication regimen are to treat or prevent cardiovascular comorbid conditions and keep a stable mineral blood balance, for instance by giving phosphate binders13; this regimen consists of an average of 12 different drugs.14 Attendance at the prescribed dialysis sessions implies both regular attendance (no skipping of sessions) and full completion of the sessions (no shortening of a session).

Because of the demands of hemodialysis, many patients might not adhere to the prescribed regimen, thereby jeopardizing successful clinical outcomes. We provide an overview of the prevalence and consequences of nonadherence to the different aspects of hemodialysis and address a few methodological obstacles to research on adherence to hemodialysis. We used the following key words to search the research literature (1988–2005) listed in the MED-LINE and CINAHL databases: nonadherence, adherence, compliance, noncompliance, end-stage renal disease, chronic renal failure, treatment failure, treatment adherence, hemodialysis, and renal replacement therapy. We also consulted reference lists and the Cochrane library for articles on adherence/compliance or nonadherence/noncompliance and hemodialysis.


About one third of hemodialysis patients survive 5 years, whereas 70% of transplant recipients are alive after 5 years.

 


   Prevalence of Nonadherence
Top
 Abstract
 Prevalence of Nonadherence
Consequences of Nonadherence
 Conclusion
 References
 
We limited our review to articles that provided basic data on design, sample, setting, and measurement of nonadherence and mentioned the prevalence of at least 1 of the 4 aspects of nonadherence in a general population. We excluded studies that did not provide basic information about the methods used,15–18 did not include the prevalence of nonadherence,11,15,19–44 included children in the sample,45 were based on a sample already reported in another included research article,46,47 had biased prevalences because only nonadherers were examined,48,49 or included patients who received an adherence-enhancing intervention.50 Our search yielded 17 articles on the prevalence of nonadherence.


Patients who produce more urine can adhere to less stringent fluid restrictions than can those who are anuric.

 

Fluid Nonadherence
Nonadherence to fluid restrictions can lead to fluid overload and possibly complications such as pulmonary congestion. Fluid nonadherence can be assessed by measuring a patient’s weight gain between 2 hemodialysis sessions, called interdialytic weight gain (IWG), or weight loss during a session, called intradialytic weight loss (IWL). Nonadherence with fluid restrictions results in excess weight gain between 2 dialysis sessions (IWG), which is lost again during a dialysis session (IWL). Indirect measurement of nonadherence to fluid restriction is also possible by self-report.

Table 1Go presents an overview of the studies on fluid nonadherence and describes the different IWG-and IWL-based operational definitions. In some studies, IWG was determined only once per patient. In other studies, the mean of several IWG or IWL results were determined for each patient; the percentage of time that IWG values exceeded a chosen threshold were calculated; or the IWG or IWL was compared with a patient’s estimated dry body weight, commonly defined as the lowest weight a patient can tolerate without having signs and symptoms of hypotension.61


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  		Table 1 Prevalence of fluid nonadherence in hemodialysis patients

 
Self-reported prevalences of nonadherence with fluid restrictions ranged from 30% to 74%.53,56,57,60 Nonadherence levels measured by calculating IWG had a similarly wide range, from 10% to 60%.51–59 These wide ranges most likely are due to the heterogeneity of the samples (ie, patients from different countries, with different customs and healthcare systems) but also may be the consequence of the following biasing processes.

Self-report measures are biased because patients consistently overestimate their adherence, even if non-adherence is assessed in a nonthreatening, nonaccusatory, open-ended, and information-intensive way.62,63 IWG and IWL are biased because the values are influenced by many other variables. One possible bias is related to a patient’s residual urine volume/residual kidney function. Patients who still produce large volumes of urine must adhere to less stringent fluid restrictions than must patients who are anuric. A second possible bias is related to IWG and IWL values that have not been corrected for a patient’s body mass.64 Body weight biases the amount of IWG and IWL tolerated. Compared with a lighter patient, a heavier patient will tolerate a certain IWG better. Adjustment for a patient’s dry weight addresses this bias.10

A third possible bias is related to characteristics of the dialysis, such as the duration of a dialysis session and the length of the interval between 2 sessions. Patients have different adherence depending on the length of the interdialysis period to be bridged. Differences in daily IWG and IWL exist between the longer weekend intervals and the shorter midweek intervals.65

A fourth possible bias is the arbitrary cutoff values of IWG and IWL used to classify patients into adherent and nonadherent groups. In recent investigations, researchers used a cutoff defined by Leggat et al,54 who defined a patient as nonadherent with fluid restrictions when the patient’s IWG exceeded 5.7% of the patient’s dry weight (for a patient of 70 kg, 5.7% is >4 kg). The precise clinical relevance of this cutoff value remains controversial. A high cutoff prevents confusion between good nutritional status and nonadherent to fluid restriction guidelines.27,65–68 Having a good nutritional status, a protective factor for survival, is also reflected by somewhat higher IWG and IWL values.27

Dietary Nonadherence
Dietary nonadherence has been assessed by using indirect measures such as patients’ self-reports and direct measures such as predialysis serum levels of potassium, phosphate, urea nitrogen, and creatinine as well as predialysis normalized protein catabolic rate. Nonadherence with sodium intake guidelines is measured by determining IWG or IWL, because excessive sodium intake causes thirst and leads to fluid nonadherence.69 Table 2Go gives an overview of the prevalence of dietary noncompliance in dialysis patients on the basis of the main measurement methods used: self-reports and laboratory reports (ie, predialysis serum levels of potassium, phosphate, and urea nitrogen).


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  		Table 2 Prevalence of dietary nonadherence in hemodialysis patients

 
Estimates of nonadherence ranged from 2% to 39% for potassium intake and from 19% to 57% for phosphorus intake.51,53,54,57–59,70 Bame et al51 measured serum urea nitrogen and found that 9% of the patients were nonadherent when a cutoff of 35.7 mmol/L (100 mg/dL) was used. Self-reported estimates ranged from 24% to 81%.53,56,57,60 The wide range of these estimates is due to several factors; potassium and phosphate values reflect not only food intake27,68 but residual renal function, dialysis adequacy, time at which blood was obtained for the analysis between dialysis, acid-base and hormonal status, and adherence with medication.28,51,53,71,72 Moreover, the large diversity in estimates is due in part to the lack of generally accepted clinically validated cutoff values (ie, what level of non-adherence is related to an increased risk for poor clinical outcomes). This problem with validity is reflected by the lack of correlation53,57 or weak correlation (r = 0.08–0.10)56 of potassium and phosphate values with self-reported dietary nonadherence.


Fluid non-adherence can provoke shortness of breath, muscle cramping, dizziness, anxiety, panic, lung edema, and hypertension.

 

Medication Nonadherence
Nonadherence with the medication regimen is usually assessed by using self-reports or predialysis serum levels of phosphate, although the degree to which the results of assessment of phosphate-binding medication can be extrapolated to the rest of the medication regimen (calcium supplements, vitamins B and C, folic acid, cardiovascular drugs) is not known. The weak correlation between self-reports and phosphate measurements (r = –0.24)53 may be due to the fact that factors other than taking medication (dietary adherence, for example) also affect serum levels of phosphate.56 Assessment of serum calcium, which is generally low in cases of nonadherence, is a complementary method for evaluating adherence to use of phosphate binders.

Other methods for assessing medication nonadherence such as pill counts, prescription refills, and electronic monitoring are used infrequently. With electronic monitoring systems, the date and time of each cap opening of a pill bottle is recorded via a microprocessor. Although in other populations of patients (eg, transplant recipients) the system is an effective method for assessing nonadherence with the medication regimen,73,74 we found only 1 study71 in which electronic monitoring was used with hemodialysis patients. Use of a combination of methods to assess medication nonadherence (ie, assay, self-report, and electronic monitoring) would be preferable to increase the reliability and validity of the results.62

Studies listed in Table 3Go and those on serum levels of phosphate in Table 2Go present an overview of the estimated nonadherence prevalences51,53,54,57–59,70 with medication taking in hemodialysis studies. The estimated prevalences ranged from 19% to 99%.51,53,71 Part of the variation can again be attributed to the chosen method of measurement and the cutoff value used.


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  		Table 3 Prevalence of medication nonadherence in hemodialysis patients

 
Appointment Nonadherence
Appointment nonadherence refers to data gathered by the dialysis staff about missed and shortened treatments, along with the total treatment time missed. Missed treatments, the percentage of nonattendance, are the number of sessions skipped compared with the number of sessions prescribed during a specific time. Shortened treatments are the percentage of the prescribed time of the attended sessions a patient actually receives dialysis or the percentage of appointments shortened by a certain amount of time. The total missed treatment time covers both the skipping and the shortening dimensions of appointment nonadherence; this time is the percentage of time a patient received dialysis compared with the total time prescribed in both attended and unattended sessions. These definitions provide a clear and easy measure of nonadherence and are therefore recommended.

Table 4Go presents an overview of appointment nonadherence studies. In the absence of agreed cutoff points to classify patients as adherent or nonadherent, the percentage of patients who are nonadherent through skipping varied from 0% to 35%29,54,59,70,75–78 and through shortening from 7% to 32%.54,59,70,75 Most studies on appointment nonadherence were done in the United States. These results might not be representative of other healthcare systems.


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  		Table 4 Prevalence of appointment nonadherence in hemodialysis patients

 

   Consequences of Nonadherence
Top
 Abstract
 Prevalence of Nonadherence
 Consequences of Nonadherence
Conclusion
 References
 
Adherence with the prescribed medical regimen is a crucial factor for achieving good therapeutic results in dialysis patients and contributes to better outcomes by reducing morbidity and mortality11 and the side effects of hemodialysis (eg, muscle cramping, malnutrition, sepsis, infection). In the following sections, we summarize the existing evidence on the relation between nonadherence and the different aspects of hemodialysis therapy and clinical outcome. Our literature search yielded 13 articles on the clinical consequences of nonadherence with 1 of the 4 aspects.24,27,30–32,47,54,66,79–83 Table 5Go is an overview of the results of 8 of the studies.


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  		Table 5 Clinical consequences of nonadherence with hemodialysis treatment

 
Fluid Nonadherence
Nonadherence with fluid restrictions can cause shortness of breath, muscle cramping, dizziness, anxiety, panic, lung edema, and hypertension. Although hypertension is a known risk factor for cardiovascular disease, which is the most important cause of mortality in patients receiving hemodialysis,5,24,30,84 the results of studies on the relationship between nonadherence with fluid restrictions and mortality were inconsistent, showing positive27,54,79 as well as negative30,66 or no relationships.31 These results may indicate that other variables, such as nutritional status and age, act as mediating factors.27,30


Skipping at least one dialysis session is associated with a 25% to 30% increase in the risk of death.

 

Higher IWGs or IWLs may reflect a good nutritional status, and thus be protective, at least in younger patients, who can tolerate larger IWGs and IWLs.27,30 High IWGs and IWLs seem to be particularly risky in patients with low nutritional status.27 Further research is needed to disentangle the role of the different variables involved in determining IWG and IWL and to determine the exact conditions under which IWG and IWL are related to survival or to mortality.

Dietary and Medication Nonadherence
Nonadherence with the dietary and medication regimens can result in chronically elevated serum levels of phosphate, which play an important role in the development of secondary hyperparathyroidism and renal osteodystrophy.33 Elevated levels of phosphate also may increase coronary artery disease, even in young patients,80 leading to a significantly increased risk for mortality.47,54,81,82 Serum levels of phosphate greater than the reference range (ie, >2.10 mmol/L [>6.5 mg/dL]) were associated with an increased adjusted relative mortality risk.54,79,82


There are no standardized methods for measuring nonadherence to the hemodialysis regimen.

 

Appointment Nonadherence
Skipping or shortening dialysis sessions decreases the delivered dialysis dose and thus the adequacy of the dialysis. The dose is assessed by using the following indicators: (1) Kt/V (K = dialyzer clearance of urea, t = dialysis time, and V = patient’s total body water), a dimensionless index based on the urea clearance rate, and (2) the urea reduction ratio, the decrease in the serum urea nitrogen concentration during the dialysis session.85,86 A lower delivered dose, as assessed by calculating Kt/V or the urea reduction ratio, has been reported to increase mortality,32,87 although the exact details of this relationship are controversial.88 In studies in which the delivered dialysis dose was determined by assessing appointment nonadherence, the relationship between the dose and higher mortality54,79,83 or higher blood pressure24 was significant. Skipping at least 1 dialysis session per month has been associated with a 25% to 30% higher risk of death.54,79 Shortening frequently more than 10 minutes (=3 times per month) also has been associated with increased mortality.54


   Conclusion
Top
 Abstract
 Prevalence of Nonadherence
 Consequences of Nonadherence
 Conclusion
References
 
In this literature overview, we focused on non-adherence to hemodialysis treatment. Nonadherence with fluid intake restrictions has received the most attention in the dialysis literature. Few researchers have explored medication adherence by using a method other than assays of serum phosphate. No study to date has included all 4 aspects of the hemodialysis regimen, namely adherence related to fluid restrictions, dietary guidelines, medication, and dialysis appointments.

The prevalence of nonadherence with the different aspects of the dialysis regimen seems considerable. However, assessment of nonadherence has 2 major obstacles: inconsistencies in definitions and invalid measurement methods. Little consensus exists among researchers about standardized methods for measuring nonadherence. Without uniformly applied standardized criteria, the literature on the prevalence and consequences of nonadherence remains difficult to interpret. Development of these standards by linking adherence levels to clinical outcomes should result in clinically relevant definitions of nonadherence; operational definitions should indicate which level and type of adherence are associated with adverse outcomes in terms of morbidity and mortality.

Despite problems with the validity of the current assessment methods of fluid, diet, and medication nonadherence, excessive nonadherence is associated with higher morbidity and mortality. Also, appointment nonadherence, especially skipping hemodialysis sessions, is associated with higher morbidity and mortality. This evidence indicates that the behavioral dimension of hemodialysis must be considered to guarantee adequate treatment results. Nurses are in an excellent position to target this behavioral dimension by assessing adherence as an important clinical parameter and by implementing adherence-enhancing interventions that have the ultimate goal of improving clinical outcomes.

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SEE ALSO
To learn more about treating patients with renal disease, visit http://ccn.aacnjournals.org and read the article by Broscious and Castagnola, "Chronic Kidney Disease: Acute Manifestations and Role of Critical Care Nurses" (Critical Care Nurse, August 2006).

FINANCIAL DISCLOSURES
None reported.


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Top
 Abstract
 Prevalence of Nonadherence
 Consequences of Nonadherence
 Conclusion
 References
 

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