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Fink HA, Ishani A, Taylor BC, et al. Chronic Kidney Disease Stages 1–3: Screening, Monitoring, and Treatment [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Jan. (Comparative Effectiveness Reviews, No. 37.)
This publication is provided for historical reference only and the information may be out of date.
Chronic Kidney Disease Stages 1–3: Screening, Monitoring, and Treatment [Internet].
Show detailsKey Question 1. In asymptomatic adults with or without recognized risk factors for CKD incidence, progression, or complications, what direct evidence is there that systematic CKD screening improves clinical outcomes?
Knowledge Gaps
- No RCT evidence directly addresses whether systematic CKD screening improves clinical outcomes.
- Sensitivity and specificity of one-time measures of microalbuminuria, macroalbuminuria and eGFR for persistent (at least 3 months' duration) CKD is unknown; impact of patient factors on persistence also is unknown.
- Only two trials were performed in patients with CKD identified through screening.
Research Recommendations
- Long-term RCTs of systematic CKD screening versus usual care adequately powered to evaluate impact on clinical outcomes.
- Target populations with high CKD prevalence and high risk for complications.
- May test different screening measures (e.g., microalbuminuria, macroalbuminuria, eGFR, combination).
- Modeling studies evaluating efficacy and harms of different CKD screening strategies versus usual care. In addition to parameters in published models, consider impact of:
- Variations in target populations.
- Variations in screening measures and frequency.
- Prevalence in target population of indications for and use of specific CKD treatments.
- Yield of one-time screening tests based on actual association with persistent CKD.
- Take into account potential screening harms.
- Determine eGFR and albuminuria from baseline and followup blood and urine available from large prospective cohorts or RCT/CCT control groups (or collect new samples).
- Estimate the proportion of individuals with abnormal one-time abnormalities who meet criteria for CKD for at least 3 months.
- Evaluate impact of patient factors on persistence (e.g., eGFR severity, albuminuria, age)
Key Question 2. What harms result from systematic CKD screening in asymptomatic adults with or without recognized risk factors for CKD incidence, progression or complications?
Knowledge Gaps
- No RCT evidence directly addresses whether systematic CKD screening increases harms.
Research Recommendations
- Long-term RCT comparing systematic CKD screening versus usual care to assess potential screening harms.
- Potential harms should be predefined, and collected and reported in all study participants.
- Potential harms may include adverse effects from screening/followup tests, including from false positive tests; psychological effects of labeling asymptomatic individuals as diseased; medication adverse effects; increased medical visits; increased costs; difficulty keeping health insurance.
- Prospectively collect predefined harms data (see above list) from all participants in large, observational CKD screening cohort studies.
- As above, conduct modeling studies evaluating the effectiveness and harms of different CKD screening strategies versus usual care.
Key Question 3. Among adults with CKD stages 1–3, whether detected by systematic screening or as part of routine care, what direct evidence is there that monitoring for worsening kidney function and/or kidney damage improves clinical outcomes?
Knowledge Gaps
- No RCT evidence directly addresses whether systematic CKD monitoring for worsened kidney function or damage improves clinical outcomes.
- Sensitivity and specificity of changes in eGFR and albuminuria for CKD progression is unknown.
- Limited RCT data address whether treatment relative risk reduction for clinical outcomes differs based on CKD severity that could inform decisions regarding whether to change treatment in patients identified by monitoring with worsened CKD severity‥
- No RCT data address whether treatments have different relative risk reduction in clinical outcomes between patients with recently worsened kidney function or damage, as detectable by monitoring, compared with in those with stable CKD.
Research Recommendations
- Long-term RCTs of systematic CKD monitoring versus usual care adequately powered to evaluate impact on clinical outcomes.
- Target populations with high risk for CKD complications.
- Consider testing different monitoring measures, alone and in combination (e.g., quantitative microalbuminuria, macroalbuminuria, eGFR)
- Modeling studies evaluating efficacy and harms of different CKD monitoring strategies versus usual care. Parameters these models may include:
- Variations in monitoring measures and frequency (quantitative albuminuria, eGFR, or a combination)
- Variations in baseline CKD severity (i.e., stage, eGFR, quantitative albuminuria)
- Variations in CKD patient characteristics (e.g., diabetes, hypertension, age, cardiovascular disease, hyperlipidemia, race/ethnicity), including possible indication for specific CKD treatments and prevalence of use of these treatments
- Take into account potential monitoring harms
Key Question 4. Among adults with CKD stages 1–3, whether detected by systematic screening or as part of routine care, what harms result from monitoring for worsening kidney function and/or kidney damage?
Knowledge Gaps
- No RCT evidence directly addresses whether systematic CKD monitoring for worsening kidney function or damage increases harms.
Research Recommendations
- Long term RCT comparing systematic CKD monitoring versus usual care to assess potential monitoring harms.
- Potential harms associated with monitoring should be predefined and collected and reported in all study participants.
- Potential harms may include adverse effects from monitoring/followup tests, including from false positive (for progression) tests; medication adverse effects; increased medical visits; increased costs.
- Prospectively collect predefined harms data (see above list) from all participants in large, observational CKD monitoring cohort studies.
- As above, conduct modeling studies evaluating the effectiveness and harms of different CKD monitoring strategies versus usual care.
Key Question 5. Among adults with CKD stages 1–3, whether detected by systematic screening or as part of routine care, what direct evidence is there that treatment improves clinical outcomes?
Knowledge Gaps
- Limited RCT data address whether relative efficacy of treatments differs between patients with and without CKD.
- Limited RCT data address whether treatment risk reduction differs based on CKD severity.
- Limited RCT data address whether treatments improved outcomes in CKD subgroups in whom treatments were not already indicated.
- In RCTs of high versus low dose, combination versus monotherapy, and strict versus standard control, it was unclear whether intensification of treatment improves clinical outcomes.
- Effect of diet interventions on clinical outcomes in patients with CKD stages 1–3 is unclear because diet intervention RCTs were small, included both patients with CKD stages 1–3 and 4–5, and did not separate results by CKD stage or severity.
- In head-to-head RCTs, there was little evidence of a significant difference in mortality or any clinical vascular outcome between different active treatment groups.
- Trials used heterogeneous eligibility criteria for kidney function and damage, and rarely reported outcomes stratified by CKD stage or albuminuria category, impeding evidence synthesis.
Research Recommendations
- Post hoc analyses of ongoing or completed RCTs that already have or are collecting clinical outcomes.
- Determine baseline eGFR and quantitative albuminuria, categorize participants by CKD stage and albuminuria category, and perform analyses to evaluate relative effectiveness of treatment versus control on clinical outcomes within these strata.
- Merge data from large scale treatment RCTs with Medicare data to identify incident ESRD cases occurring in post-trial followup period.
- Long-term RCTs of CKD treatment adequately powered to evaluate impact on clinical outcomes.
- In addition to mortality, ESRD, and clinical vascular outcomes, additional clinical outcomes to consider for evaluation include quality of life, acute kidney injury complications (e.g., hospitalization), healthcare utilization, physical function, and cognitive function.
- If composite outcomes reported, complete data also should be reported for individual composite components.
- To increase trial relevance to a screened population, consider recruitment using population-based sampling.
- Stratify results by CKD stage, albuminuria category, and other characteristics associated with CKD complications, including diabetes, hypertension, cardiovascular disease, older age, race/ethnicity, obesity, and hyperlipidemia.
- Consider future RCTs of statins in patients with albuminuria, AECI, or ARB in patients with macroalbuminuria, ACEI or ARB in combination with other therapy, and of treatments other than ACEI or ARB.
- Consider trials of dietary interventions restricted to patients with CKD stages 1–3.
- Consider trials comparing system level interventions to aid providers in avoidance of nephrotoxic agents, medication renal dose adjustment, and other measures targeted to reduce CKD associated complications versus usual care.
- Patient level meta-analyses of treatment RCTs to evaluate the effect of treatments relative to control in relevant CKD subgroups.
- Analysis of administrative data to evaluate effect of nephrology referral on clinical outcomes, performing propensity analysis to account for factors associated with early referral.
Key Question 6. Among adults with CKD stages 1–3, whether detected by systematic screening or as part of routine care, what harms result from treatment?
Knowledge Gaps
- Withdrawals and adverse events were reported in few RCTs.
- Withdrawals often were not reported separately by treatment group; adverse events often did not appear predefined, systematically collected and reported, or separated by treatment group.
Research Recommendations
- In future RCTs, withdrawals and adverse effects should be predefined and collected and reported in all patients with CKD stages 1–3.
- Withdrawal and adverse effects may be reported stratified by CKD stage and albuminuria category, and other patient characteristics.
- In asymptomatic adults with or without recognized risk factors for CKD incidence, progression, or complications, what direct evidence is there that systematic CKD screening improves clinical outcomes?
- What harms result from systematic CKD screening in asymptomatic adults with or without recognized risk factors for CKD incidence, progression or complications?
- Among adults with CKD stages 1–3, whether detected by systematic screening or as part of routine care, what direct evidence is there that monitoring for worsening kidney function and/or kidney damage improves clinical outcomes?
- Among adults with CKD stages 1–3, whether detected by systematic screening or as part of routine care, what harms result from monitoring for worsening kidney function and/or kidney damage?
- Among adults with CKD stages 1–3, whether detected by systematic screening or as part of routine care, what direct evidence is there that treatment improves clinical outcomes?
- Among adults with CKD stages 1–3, whether detected by systematic screening or as part of routine care, what harms result from treatment?
- Future Research Recommendations - Chronic Kidney Disease Stages 1–3Future Research Recommendations - Chronic Kidney Disease Stages 1–3
- Marketing of Health ServicesMarketing of Health ServicesApplication of marketing principles and techniques to maximize the use of health care resources.<br/>Year introduced: 1980(1979)MeSH
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