Multiple-frequency bioimpedance devices for fluid management in people with chronic kidney disease receiving dialysis: a systematic review and economic evaluation

Graham Scotland, Moira Cruickshank, Elisabet Jacobsen, David Cooper, Cynthia Fraser, Michal Shimonovich, Angharad Marks, Miriam Brazzelli

Research output: Contribution to journalLiterature review

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Abstract

BACKGROUND: Chronic kidney disease (CKD) is a long-term condition requiring treatment such as conservative management, kidney transplantation or dialysis. To optimise the volume of fluid removed during dialysis (to avoid underhydration or overhydration), people are assigned a 'target weight', which is commonly assessed using clinical methods, such as weight gain between dialysis sessions, pre- and post-dialysis blood pressure and patient-reported symptoms. However, these methods are not precise, and measurement devices based on bioimpedance technology are increasingly used in dialysis centres. Current evidence on the role of bioimpedance devices for fluid management in people with CKD receiving dialysis is limited.

OBJECTIVES: To evaluate the clinical effectiveness and cost-effectiveness of multiple-frequency bioimpedance devices versus standard clinical assessment for fluid management in people with CKD receiving dialysis.

DATA SOURCES: We searched major electronic databases [e.g. MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, Science Citation Index and Cochrane Central Register of Controlled Trials (CENTRAL)] conference abstracts and ongoing studies. There were no date restrictions. Searches were undertaken between June and October 2016.

REVIEW METHODS: Evidence was considered from randomised controlled trials (RCTs) comparing fluid management by multiple-frequency bioimpedance devices and standard clinical assessment in people receiving dialysis, and non-randomised studies evaluating the use of the devices for fluid management in people receiving dialysis. One reviewer extracted data and assessed the risk of bias of included studies. A second reviewer cross-checked the extracted data. Standard meta-analyses techniques were used to combine results from included studies. A Markov model was developed to assess the cost-effectiveness of the interventions.

RESULTS: Five RCTs (with 904 adult participants) and eight non-randomised studies (with 4915 adult participants) assessing the use of the Body Composition Monitor [(BCM) Fresenius Medical Care, Bad Homburg vor der Höhe, Germany] were included. Both absolute overhydration and relative overhydration were significantly lower in patients evaluated using BCM measurements than for those evaluated using standard clinical methods [weighted mean difference -0.44, 95% confidence interval (CI) -0.72 to -0.15, p = 0.003, I2 = 49%; and weighted mean difference -1.84, 95% CI -3.65 to -0.03; p = 0.05, I2 = 52%, respectively]. Pooled effects of bioimpedance monitoring on systolic blood pressure (SBP) (mean difference -2.46 mmHg, 95% CI -5.07 to 0.15 mmHg; p = 0.06, I2 = 0%), arterial stiffness (mean difference -1.18, 95% CI -3.14 to 0.78; p = 0.24, I2 = 92%) and mortality (hazard ratio = 0.689, 95% CI 0.23 to 2.08; p = 0.51) were not statistically significant. The economic evaluation showed that, when dialysis costs were included in the model, the probability of bioimpedance monitoring being cost-effective ranged from 13% to 26% at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained. With dialysis costs excluded, the corresponding probabilities of cost-effectiveness ranged from 61% to 67%.

LIMITATIONS: Lack of evidence on clinically relevant outcomes, children receiving dialysis, and any multifrequency bioimpedance devices, other than the BCM.

CONCLUSIONS: BCM used in addition to clinical assessment may lower overhydration and potentially improve intermediate outcomes, such as SBP, but effects on mortality have not been demonstrated. If dialysis costs are not considered, the incremental cost-effectiveness ratio falls below £20,000, with modest effects on mortality and/or hospitalisation rates. The current findings are not generalisable to paediatric populations nor across other multifrequency bioimpedance devices.

FUTURE WORK: Services that routinely use the BCM should report clinically relevant intermediate and long-term outcomes before and after introduction of the device to extend the current evidence base.

STUDY REGISTRATION: This study is registered as PROSPERO CRD42016041785.

FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Original languageEnglish
Pages (from-to)1-138
Number of pages138
JournalHealth Technology Assessment
Volume22
Issue number1
DOIs
Publication statusPublished - 31 Jan 2018

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Chronic Renal Insufficiency
Cost-Benefit Analysis
Dialysis
Equipment and Supplies
Body Composition
Confidence Intervals
Blood Pressure
Costs and Cost Analysis
MEDLINE
Mortality
Randomized Controlled Trials
Biomedical Technology Assessment
Vascular Stiffness
Quality-Adjusted Life Years
National Institutes of Health (U.S.)
Kidney Transplantation
Weight Gain
Germany
Meta-Analysis
Hospitalization

Keywords

  • Meta-Analysis

Cite this

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title = "Multiple-frequency bioimpedance devices for fluid management in people with chronic kidney disease receiving dialysis: a systematic review and economic evaluation",
abstract = "BACKGROUND: Chronic kidney disease (CKD) is a long-term condition requiring treatment such as conservative management, kidney transplantation or dialysis. To optimise the volume of fluid removed during dialysis (to avoid underhydration or overhydration), people are assigned a 'target weight', which is commonly assessed using clinical methods, such as weight gain between dialysis sessions, pre- and post-dialysis blood pressure and patient-reported symptoms. However, these methods are not precise, and measurement devices based on bioimpedance technology are increasingly used in dialysis centres. Current evidence on the role of bioimpedance devices for fluid management in people with CKD receiving dialysis is limited.OBJECTIVES: To evaluate the clinical effectiveness and cost-effectiveness of multiple-frequency bioimpedance devices versus standard clinical assessment for fluid management in people with CKD receiving dialysis.DATA SOURCES: We searched major electronic databases [e.g. MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, Science Citation Index and Cochrane Central Register of Controlled Trials (CENTRAL)] conference abstracts and ongoing studies. There were no date restrictions. Searches were undertaken between June and October 2016.REVIEW METHODS: Evidence was considered from randomised controlled trials (RCTs) comparing fluid management by multiple-frequency bioimpedance devices and standard clinical assessment in people receiving dialysis, and non-randomised studies evaluating the use of the devices for fluid management in people receiving dialysis. One reviewer extracted data and assessed the risk of bias of included studies. A second reviewer cross-checked the extracted data. Standard meta-analyses techniques were used to combine results from included studies. A Markov model was developed to assess the cost-effectiveness of the interventions.RESULTS: Five RCTs (with 904 adult participants) and eight non-randomised studies (with 4915 adult participants) assessing the use of the Body Composition Monitor [(BCM) Fresenius Medical Care, Bad Homburg vor der H{\"o}he, Germany] were included. Both absolute overhydration and relative overhydration were significantly lower in patients evaluated using BCM measurements than for those evaluated using standard clinical methods [weighted mean difference -0.44, 95{\%} confidence interval (CI) -0.72 to -0.15, p = 0.003, I2 = 49{\%}; and weighted mean difference -1.84, 95{\%} CI -3.65 to -0.03; p = 0.05, I2 = 52{\%}, respectively]. Pooled effects of bioimpedance monitoring on systolic blood pressure (SBP) (mean difference -2.46 mmHg, 95{\%} CI -5.07 to 0.15 mmHg; p = 0.06, I2 = 0{\%}), arterial stiffness (mean difference -1.18, 95{\%} CI -3.14 to 0.78; p = 0.24, I2 = 92{\%}) and mortality (hazard ratio = 0.689, 95{\%} CI 0.23 to 2.08; p = 0.51) were not statistically significant. The economic evaluation showed that, when dialysis costs were included in the model, the probability of bioimpedance monitoring being cost-effective ranged from 13{\%} to 26{\%} at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained. With dialysis costs excluded, the corresponding probabilities of cost-effectiveness ranged from 61{\%} to 67{\%}.LIMITATIONS: Lack of evidence on clinically relevant outcomes, children receiving dialysis, and any multifrequency bioimpedance devices, other than the BCM.CONCLUSIONS: BCM used in addition to clinical assessment may lower overhydration and potentially improve intermediate outcomes, such as SBP, but effects on mortality have not been demonstrated. If dialysis costs are not considered, the incremental cost-effectiveness ratio falls below £20,000, with modest effects on mortality and/or hospitalisation rates. The current findings are not generalisable to paediatric populations nor across other multifrequency bioimpedance devices.FUTURE WORK: Services that routinely use the BCM should report clinically relevant intermediate and long-term outcomes before and after introduction of the device to extend the current evidence base.STUDY REGISTRATION: This study is registered as PROSPERO CRD42016041785.FUNDING: The National Institute for Health Research Health Technology Assessment programme.",
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author = "Graham Scotland and Moira Cruickshank and Elisabet Jacobsen and David Cooper and Cynthia Fraser and Michal Shimonovich and Angharad Marks and Miriam Brazzelli",
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year = "2018",
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TY - JOUR

T1 - Multiple-frequency bioimpedance devices for fluid management in people with chronic kidney disease receiving dialysis

T2 - a systematic review and economic evaluation

AU - Scotland, Graham

AU - Cruickshank, Moira

AU - Jacobsen, Elisabet

AU - Cooper, David

AU - Fraser, Cynthia

AU - Shimonovich, Michal

AU - Marks, Angharad

AU - Brazzelli, Miriam

N1 - The National Institute for Health Research Health Technology Assessment programme.

PY - 2018/1/31

Y1 - 2018/1/31

N2 - BACKGROUND: Chronic kidney disease (CKD) is a long-term condition requiring treatment such as conservative management, kidney transplantation or dialysis. To optimise the volume of fluid removed during dialysis (to avoid underhydration or overhydration), people are assigned a 'target weight', which is commonly assessed using clinical methods, such as weight gain between dialysis sessions, pre- and post-dialysis blood pressure and patient-reported symptoms. However, these methods are not precise, and measurement devices based on bioimpedance technology are increasingly used in dialysis centres. Current evidence on the role of bioimpedance devices for fluid management in people with CKD receiving dialysis is limited.OBJECTIVES: To evaluate the clinical effectiveness and cost-effectiveness of multiple-frequency bioimpedance devices versus standard clinical assessment for fluid management in people with CKD receiving dialysis.DATA SOURCES: We searched major electronic databases [e.g. MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, Science Citation Index and Cochrane Central Register of Controlled Trials (CENTRAL)] conference abstracts and ongoing studies. There were no date restrictions. Searches were undertaken between June and October 2016.REVIEW METHODS: Evidence was considered from randomised controlled trials (RCTs) comparing fluid management by multiple-frequency bioimpedance devices and standard clinical assessment in people receiving dialysis, and non-randomised studies evaluating the use of the devices for fluid management in people receiving dialysis. One reviewer extracted data and assessed the risk of bias of included studies. A second reviewer cross-checked the extracted data. Standard meta-analyses techniques were used to combine results from included studies. A Markov model was developed to assess the cost-effectiveness of the interventions.RESULTS: Five RCTs (with 904 adult participants) and eight non-randomised studies (with 4915 adult participants) assessing the use of the Body Composition Monitor [(BCM) Fresenius Medical Care, Bad Homburg vor der Höhe, Germany] were included. Both absolute overhydration and relative overhydration were significantly lower in patients evaluated using BCM measurements than for those evaluated using standard clinical methods [weighted mean difference -0.44, 95% confidence interval (CI) -0.72 to -0.15, p = 0.003, I2 = 49%; and weighted mean difference -1.84, 95% CI -3.65 to -0.03; p = 0.05, I2 = 52%, respectively]. Pooled effects of bioimpedance monitoring on systolic blood pressure (SBP) (mean difference -2.46 mmHg, 95% CI -5.07 to 0.15 mmHg; p = 0.06, I2 = 0%), arterial stiffness (mean difference -1.18, 95% CI -3.14 to 0.78; p = 0.24, I2 = 92%) and mortality (hazard ratio = 0.689, 95% CI 0.23 to 2.08; p = 0.51) were not statistically significant. The economic evaluation showed that, when dialysis costs were included in the model, the probability of bioimpedance monitoring being cost-effective ranged from 13% to 26% at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained. With dialysis costs excluded, the corresponding probabilities of cost-effectiveness ranged from 61% to 67%.LIMITATIONS: Lack of evidence on clinically relevant outcomes, children receiving dialysis, and any multifrequency bioimpedance devices, other than the BCM.CONCLUSIONS: BCM used in addition to clinical assessment may lower overhydration and potentially improve intermediate outcomes, such as SBP, but effects on mortality have not been demonstrated. If dialysis costs are not considered, the incremental cost-effectiveness ratio falls below £20,000, with modest effects on mortality and/or hospitalisation rates. The current findings are not generalisable to paediatric populations nor across other multifrequency bioimpedance devices.FUTURE WORK: Services that routinely use the BCM should report clinically relevant intermediate and long-term outcomes before and after introduction of the device to extend the current evidence base.STUDY REGISTRATION: This study is registered as PROSPERO CRD42016041785.FUNDING: The National Institute for Health Research Health Technology Assessment programme.

AB - BACKGROUND: Chronic kidney disease (CKD) is a long-term condition requiring treatment such as conservative management, kidney transplantation or dialysis. To optimise the volume of fluid removed during dialysis (to avoid underhydration or overhydration), people are assigned a 'target weight', which is commonly assessed using clinical methods, such as weight gain between dialysis sessions, pre- and post-dialysis blood pressure and patient-reported symptoms. However, these methods are not precise, and measurement devices based on bioimpedance technology are increasingly used in dialysis centres. Current evidence on the role of bioimpedance devices for fluid management in people with CKD receiving dialysis is limited.OBJECTIVES: To evaluate the clinical effectiveness and cost-effectiveness of multiple-frequency bioimpedance devices versus standard clinical assessment for fluid management in people with CKD receiving dialysis.DATA SOURCES: We searched major electronic databases [e.g. MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, Science Citation Index and Cochrane Central Register of Controlled Trials (CENTRAL)] conference abstracts and ongoing studies. There were no date restrictions. Searches were undertaken between June and October 2016.REVIEW METHODS: Evidence was considered from randomised controlled trials (RCTs) comparing fluid management by multiple-frequency bioimpedance devices and standard clinical assessment in people receiving dialysis, and non-randomised studies evaluating the use of the devices for fluid management in people receiving dialysis. One reviewer extracted data and assessed the risk of bias of included studies. A second reviewer cross-checked the extracted data. Standard meta-analyses techniques were used to combine results from included studies. A Markov model was developed to assess the cost-effectiveness of the interventions.RESULTS: Five RCTs (with 904 adult participants) and eight non-randomised studies (with 4915 adult participants) assessing the use of the Body Composition Monitor [(BCM) Fresenius Medical Care, Bad Homburg vor der Höhe, Germany] were included. Both absolute overhydration and relative overhydration were significantly lower in patients evaluated using BCM measurements than for those evaluated using standard clinical methods [weighted mean difference -0.44, 95% confidence interval (CI) -0.72 to -0.15, p = 0.003, I2 = 49%; and weighted mean difference -1.84, 95% CI -3.65 to -0.03; p = 0.05, I2 = 52%, respectively]. Pooled effects of bioimpedance monitoring on systolic blood pressure (SBP) (mean difference -2.46 mmHg, 95% CI -5.07 to 0.15 mmHg; p = 0.06, I2 = 0%), arterial stiffness (mean difference -1.18, 95% CI -3.14 to 0.78; p = 0.24, I2 = 92%) and mortality (hazard ratio = 0.689, 95% CI 0.23 to 2.08; p = 0.51) were not statistically significant. The economic evaluation showed that, when dialysis costs were included in the model, the probability of bioimpedance monitoring being cost-effective ranged from 13% to 26% at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained. With dialysis costs excluded, the corresponding probabilities of cost-effectiveness ranged from 61% to 67%.LIMITATIONS: Lack of evidence on clinically relevant outcomes, children receiving dialysis, and any multifrequency bioimpedance devices, other than the BCM.CONCLUSIONS: BCM used in addition to clinical assessment may lower overhydration and potentially improve intermediate outcomes, such as SBP, but effects on mortality have not been demonstrated. If dialysis costs are not considered, the incremental cost-effectiveness ratio falls below £20,000, with modest effects on mortality and/or hospitalisation rates. The current findings are not generalisable to paediatric populations nor across other multifrequency bioimpedance devices.FUTURE WORK: Services that routinely use the BCM should report clinically relevant intermediate and long-term outcomes before and after introduction of the device to extend the current evidence base.STUDY REGISTRATION: This study is registered as PROSPERO CRD42016041785.FUNDING: The National Institute for Health Research Health Technology Assessment programme.

KW - Meta-Analysis

U2 - 10.3310/hta22010

DO - 10.3310/hta22010

M3 - Literature review

VL - 22

SP - 1

EP - 138

JO - Health Technology Assessment

JF - Health Technology Assessment

SN - 1366-5278

IS - 1

ER -