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Meta-Analysis
. 2024 Aug 22;8(8):CD007374.
doi: 10.1002/14651858.CD007374.pub3.

Education programmes for people with chronic kidney disease and diabetes

Brydee A Cashmore  1   2 , Tess E Cooper  3 , Nicole M Evangelidis  2 , Suetonia C Green  4 , Pamela Lopez-Vargas  1 , David J Tunnicliffe  1   2
Affiliations
Meta-Analysis

Education programmes for people with chronic kidney disease and diabetes

Brydee A Cashmore et al. Cochrane Database Syst Rev. .

Abstract

Background: Adherence to complex regimens for people with chronic kidney disease (CKD) and diabetes is often poor. Interventions to enhance adherence require intensive education and behavioural counselling. However, whether the existing evidence is scientifically rigorous and can support recommendations for routine use of educational programmes in people with CKD and diabetes is still unknown. This is an update of a review first published in 2011.

Objectives: To evaluate the benefits and harms of education programmes for people with CKD and diabetes.

Search methods: We searched the Cochrane Kidney and Transplant Register of Studies up to 19 July 2024 using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal, and ClinicalTrials.gov.

Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs investigating the benefits and harms of educational programmes (information and behavioural instructions and advice given by a healthcare provider, who could be a nurse, pharmacist, educator, health professional, medical practitioner, or healthcare provider, through verbal, written, audio-recording, or computer-aided modalities) for people 18 years and older with CKD and diabetes.

Data collection and analysis: Two authors independently screened the literature, determined study eligibility, assessed quality, and extracted and entered data. We expressed dichotomous outcomes as risk ratios (RR) with 95% confidence intervals (CI) and continuous data as mean difference (MD) with 95% CI. Data were pooled using the random-effects model. The certainty of the evidence was assessed using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach.

Main results: Eight studies (13 reports, 840 randomised participants) were included. The overall risk of bias was low for objective outcomes and attrition bias, unclear for selection bias, reporting bias and other biases, and high for subjective outcomes. Education programmes compared to routine care alone probably decrease glycated haemoglobin (HbA1c) (4 studies, 467 participants: MD -0.42%, 95% CI -0.53 to -0.31; moderate certainty evidence; 13.5 months follow-up) and may decrease total cholesterol (179 participants: MD -0.35 mmol/L, 95% CI -0.63 to -00.07; low certainty evidence) and low-density lipoprotein (LDL) cholesterol (179 participants: MD -0.40 mmol/L, 95% CI -0.65 to -0.14; low certainty evidence) at 18 months of follow-up. One study (83 participants) reported education programmes for people receiving dialysis who have diabetes may improve the diabetes knowledge of diagnosis, monitoring, hypoglycaemia, hyperglycaemia, medication with insulin, oral medication, personal health habits, diet, exercise, chronic complications, and living with diabetes and coping with stress (all low certainty evidence). There may be an improvement in the general knowledge of diabetes at the end of the intervention and at the end of the three-month follow-up (one study, 97 participants; low certainty evidence) in people with diabetes and moderately increased albuminuria (A2). In participants with diabetes and moderately increased albuminuria (A2) (one study, 97 participants), education programmes may improve a participant's beliefs in treatment effectiveness and total self-efficacy at the end of five weeks compared to routine care (low certainty evidence). Self-efficacy for in-home blood glucose monitoring and beliefs in personal control may increase at the end of the three-month follow-up (low certainty evidence). There were no differences in other self-efficacy measures. One study (100 participants) reported an education programme may increase change in behaviour for general diet, specific diet and home blood glucose monitoring at the end of treatment (low certainty evidence); however, at the end of three months of follow-up, there may be no difference in any behaviour change outcomes (all low certainty evidence). There were uncertain effects on death, serious hypoglycaemia, and kidney failure due to very low certainty evidence. No data was available for changes in kidney function (creatinine clearance, serum creatinine, doubling of serum creatinine or proteinuria). For an education programme plus multidisciplinary, co-ordinated care compared to routine care, there may be little or no difference in HbA1c, kidney failure, estimated glomerular filtration rate (eGFR), systolic or diastolic blood pressure, hypoglycaemia, hyperglycaemia, and LDL and high-density lipoprotein (HDL) cholesterol (all low certainty evidence in participants with type-2 diabetes mellitus and documented advanced diabetic nephropathy). There were no data for death, patient-orientated measures, change in kidney function (other than eGFR and albuminuria), cardiovascular disease morbidity, quality of life, or adverse events.

Authors' conclusions: Education programmes may improve knowledge of some areas related to diabetes care and some self-management practices. Education programmes probably decrease HbA1c in people with CKD and diabetes, but the effect on other clinical outcomes is unclear. This review only included eight studies with small sample sizes. Therefore, more randomised studies are needed to examine the efficacy of education programmes on important clinical outcomes in people with CKD and diabetes.

Trial registration: ClinicalTrials.gov NCT00708981 NCT00263419 NCT01212328 NCT00253786 NCT01967901 NCT02276742 NCT05319600 NCT06325917 NCT06444074 NCT00714441 NCT00320008 NCT01829256 NCT00309127 NCT00782847 NCT03413215.

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Conflict of interest statement

  1. Brydee Cashmore: No relevant interests were disclosed

  2. Tess E Cooper: No relevant interests were disclosed

  3. Nicole M Evangelidis: No relevant interests were disclosed

  4. Suetonia C Palmer: No relevant interests were disclosed

  5. Pamela Lopez‐Vargas: No relevant interests were disclosed

  6. David J Tunnicliffe: No relevant interests were disclosed

Figures

1
1
Flow chart showing study selection
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 1: Death
1.2
1.2. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 2: HbA1c [%]
1.3
1.3. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 3: Attaining HbA1c < 6.5%
1.4
1.4. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 4: Kidney failure
1.5
1.5. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 5: Patient‐oriented measures: beliefs at the end of treatment (attitude scales)
1.6
1.6. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 6: Patient‐oriented measures: beliefs at the end of follow‐up (attitude scales)
1.7
1.7. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 7: Patient‐oriented measures: knowledge of diabetes at the end of treatment
1.8
1.8. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 8: Patient‐oriented measures: general knowledge of diabetes
1.9
1.9. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 9: Patient‐oriented measures: self‐efficacy at the end of treatment
1.10
1.10. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 10: Patient‐oriented measures: self‐efficacy at the end of follow‐up
1.11
1.11. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 11: Patient‐oriented measures: self‐management behaviour changes at the end of treatment
1.12
1.12. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 12: Patient‐oriented measures: behavioural changes at the end of treatment
1.13
1.13. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 13: Patient‐oriented measures: behavioural changes at the end of follow‐up
1.14
1.14. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 14: Estimated GFR [mL/min/1.73 m2]
1.15
1.15. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 15: Urinary albumin‐creatinine ratio [mg/g]
1.16
1.16. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 16: Blood pressure [mm Hg]
1.17
1.17. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 17: Glycaemic events
1.18
1.18. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 18: Non‐fatal cardiovascular events
1.19
1.19. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 19: Quality of life
1.20
1.20. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 20: Lipids [mmol/L]
1.21
1.21. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 21: Adverse events: non‐fatal (including hypoglycaemic and CVD events)
1.22
1.22. Analysis
Comparison 1: Educational programmes plus routine care versus routine care alone, Outcome 22: Serious adverse events: emergency hospitalisation or death (including serious hypoglycaemic and CVD events)
2.1
2.1. Analysis
Comparison 2: Multidisciplinary, multifactorial education programmes versus routine care, Outcome 1: HbA1c [%]
2.2
2.2. Analysis
Comparison 2: Multidisciplinary, multifactorial education programmes versus routine care, Outcome 2: Kidney failure
2.3
2.3. Analysis
Comparison 2: Multidisciplinary, multifactorial education programmes versus routine care, Outcome 3: Estimated GFR [mL/min/1.73 m2]
2.4
2.4. Analysis
Comparison 2: Multidisciplinary, multifactorial education programmes versus routine care, Outcome 4: Blood pressure [mm Hg]
2.5
2.5. Analysis
Comparison 2: Multidisciplinary, multifactorial education programmes versus routine care, Outcome 5: Glycaemic events
2.6
2.6. Analysis
Comparison 2: Multidisciplinary, multifactorial education programmes versus routine care, Outcome 6: Lipids [mg/dL]
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Naimark 2001 {published data only}
    1. Naimark DM, Bott MT, Tobe SW. Facilitating the adoption of microalbuminuria (mau) screening among type II diabetic patients in primary care: preliminary results of a randomized educational intervention trial [abstract no: SU-P0826]. Journal of the American Society of Nephrology 2002;13(Program & Abstracts):638A. [CENTRAL: CN-00446889]
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NCT05319600 {published data only}
    1. NCT05319600. Technology-delivered physical activity program for adolescents with type 1 diabetes (Activate) [Does a behavior change skills and physical activity program improve self-regulation and health outcomes in adolescents with type 1 diabetes?]. https://clinicaltrials.gov/ct2/show/NCT05319600 2022.
NCT05357742 {published data only}
    1. NCT05357742. Basic need navigation intervention to address unmet basic needs in African Americans with diabetic kidney disease [Basic needs navigation intervention to address multidimensional adversity in African Americans with diabetic kidney disease]. https://clinicaltrials.gov/show/NCT05357742 2022.
NCT06325917 {published data only}
    1. NCT06325917. Effect of diabetes self-management education and support on glycemic control among patients with type 2 diabetic (DSMES) [Effect of self-management education with ongoing support using social media on glycemic control among patients with diabetes type 2.]. https://clinicaltrials.gov/ct2/show/NCT06325917 2023.
NCT06444074 {published data only}
    1. NCT06444074. The PACT (Patient Activation Through Conversations) study [The PACT (Patient Activation Through Conversations) study - a cluster randomised trial of a health coach-led patient activation program in type 2 diabetes]. https://clinicaltrials.gov/ct2/show/NCT06444074 2024.
Nelson 2018 {published data only}
    1. Nelson RG, Pankratz VS, Ghahate DM, Bobelu J, Faber T, Shah VO. Home-based kidney care, patient activation, and risk factors for CKD progression in Zuni Indians: a randomized, controlled clinical trial. Clinical Journal of the American Society of Nephrology: CJASN 2018;13(12):1801-9. [CENTRAL: 30442864] - PMC - PubMed
    1. Pankratz V, Choi E, Qeadan F, Ghahate D, Bobelu J, Nelson R, et al. Diabetes status modifies the efficacy of home-based kidney care for Zuni Indians in a randomized controlled trial. Journal of Diabetes & its Complications 2021;35(2):107753. [PMID: ] - PMC - PubMed
    1. Shah V, Nelson R, Pankratz V, Ghahate D, Bobelu J. Reducing health disparity - PCORI supported home based kidney care approach in Zuni Indians [abstract no: SA-OR012]. Journal of the American Society of Nephrology 2017;28:74. [EMBASE: 633700647]
Nozaki 2005 {published data only}
    1. Nozaki C, Oka M, Chaboyer W. The effects of a cognitive behavioural therapy programme for self-care on haemodialysis patients. International Journal of Nursing Practice 2005;11(5):228-36. [MEDLINE: ] - PubMed
Osaki 2017 {published data only}
    1. Kazawa K, Osaki K, Rahman MM, Moriyama M. Evaluating the effectiveness and feasibility of nurse-led distant and face-to-face interviews programs for promoting behavioral change and disease management in patients with diabetic nephropathy: a triangulation approach. BMC Nursing 2020;19:16. [MEDLINE: ] - PMC - PubMed
    1. Osaki K, Kazawa K, Moriyama M. Comparison of remote self management education with face-to-face education in patients with diabetic nephropathy: 12-month follow-up. Journal of Japan Academy of Diabetes Education & Nursing 2017;21(1):46-55.
Othman 2022 {published data only}
    1. Othman N, Gheith O, Al-Otaibi T, Said T, Halim MA, Elserwy N, et al. Effect of structured diabetes education on diabetic angiopathies among kidney transplant recipients with posttransplant diabetes: Kuwait experience. Experimental & Clinical Transplantation 2022;20(Suppl 1):46-54. [DOI: 10.6002/ect.MESOT2021.O19] [MEDLINE: ] - DOI - PubMed
Othman 2024 {published data only}
    1. Othman N, Al-Otaibi T, Halim MA, Said T, Elserwy N, Mahmoud F, et al. Effect of repeated structured diabetes education on lifestyle knowledge and self-care diabetes management in kidney transplant patients with posttransplant diabetes. Experimental & Clinical Transplantation 2024;22(Suppl 1):128‐40. [DOI: 10.6002/ect.MESOT2023.O31] [PMID: ] - DOI - PubMed
PANDIA‐IRIS 2021 {published data only}
    1. Bandiera C, Dotta-Celio J, Locatelli I, Nobre D, Wuerzner G, Pruijm M, et al. Interprofessional medication adherence program for patients with diabetic kidney disease: protocol for a randomized controlled and qualitative study (PANDIA-IRIS). JMIR Research Protocols 2021;10(3):e25966. [MEDLINE: ] - PMC - PubMed
QICKD 2009 {published data only}
    1. McGovern AP, Rusholme B, Jones S, Vlymen JN, Liyanage H, Gallagher H, et al. Association of chronic kidney disease (CKD) and failure to monitor renal function with adverse outcomes in people with diabetes: a primary care cohort study. BMC Nephrology 2013;14:198. [PMID: ] - PMC - PubMed
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Rachmani 2005 {published data only}
    1. Rachmani R, Levi Z, Slavachevski I, Avin M, Ravid M. Teaching patients to monitor their risk factors retards the progression of vascular complications in high-risk patients with Type 2 diabetes mellitus--a randomized prospective study. Diabetic Medicine 2002;19(5):385-92. [MEDLINE: ] - PubMed
    1. Rachmani R, Slavacheski I, Berla M, Frommer-Shapira R, Ravid M. Treatment of high-risk patients with diabetes: motivation and teaching intervention: a randomized, prospective 8-year follow-up study. Journal of the American Society of Nephrology 2005;16 Suppl 1:22-6. [MEDLINE: ] - PubMed
    1. Rachmani R, Slavachevski I, Berla M, Frommer-Shapira R, Ravid M. Teaching and motivating patients to control their risk factors retards progression of cardiovascular as well as microvascular sequelae of Type 2 diabetes mellitus- a randomized prospective 8 years follow-up study. Diabetic Medicine 2005;22(4):410-4. [MEDLINE: ] - PubMed
REDEEM 2013 {published data only}
    1. Fisher L, Hessler D, Glasgow RE, Arean PA, Masharani U, Naranjo D, et al. REDEEM: a pragmatic trial to reduce diabetes distress. Diabetes Care 2013;36(9):2551-8. [MEDLINE: ] - PMC - PubMed
Roddy 2022 {published data only}
    1. Roddy MK, Mayberry LS, Nair D, Cavanaugh KL. Exploring mHealth potential to improve kidney function: secondary analysis of a randomized trial of diabetes self-care in diverse adults. BMC Nephrology 2022;23(1):280. [MEDLINE: ] - PMC - PubMed
Shi 2020 {published data only}
    1. Shi C, Fang X, Yang Y, Bai R, Yu S, Sun G, et al. Intensive multifactorial intervention improved renal impairment in short-duration type 2 diabetes: a randomized, controlled, 7-year follow-up trial. Journal of Diabetes & its Complications 2020;34(1):107468. [MEDLINE: ] - PubMed
STENO‐2 1999 {published data only}
    1. Gaede P, Lund-Andersen H, Parving HH, Pedersen O. Effect of a multifactorial intervention on mortality in type 2 diabetes. New England Journal of Medicine 2008;358(6):580-91. [MEDLINE: ] - PubMed
    1. Gaede P, Oellgaard J, Kruuse C, Rossing P, Parving HH, Pedersen O. Beneficial impact of intensified multifactorial intervention on risk of stroke: outcome of 21 years of follow-up in the randomised STENO-2 Study. Diabetologia 2019;62(9):1575-80. [MEDLINE: ] - PMC - PubMed
    1. Gaede P, Parving H, Pedersen O. Multifactorial intervention in patients with type 2 diabetes: long-term effects on mortality and vascular complications [abstract no: SA-FC042]. Journal of the American Society of Nephrology 2007;18(Abstracts):43A. [CENTRAL: CN-00740461]
    1. Gaede P, Valentine WJ, Palmer AJ, Tucker DM, Lammert M, Parving HH, et al. Cost-effectiveness of intensified versus conventional multifactorial intervention in type 2 diabetes: results and projections from the STENO-2 study. Diabetes Care 2008;31(8):1510-5. [MEDLINE: ] - PMC - PubMed
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STOP‐DKD 2018 {published data only}
    1. Diamantidis CJ, Bosworth HB, Oakes MM, Davenport CA, Pendergast JF, Patel S, et al. Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study: protocol and baseline characteristics of a randomized controlled trial. Contemporary Clinical Trials 2018;69:28-39. [MEDLINE: ] - PMC - PubMed
    1. Kobe EA, Diamantidis CJ, Bosworth HB, Davenport CA, Oakes M, Alexopoulos AS, et al. Racial differences in the effectiveness of a multifactorial telehealth intervention to slow diabetic kidney disease. Medical Care 2020;58(11):968-73. [MEDLINE: ] - PMC - PubMed
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    1. Zullig LL, Jazowski SA, Davenport CA, Diamantidis CJ, Oakes MM, Patel S, et al. Primary care providers' acceptance of pharmacists' recommendations to support optimal medication management for patients with diabetic kidney disease. Journal of General Internal Medicine 2020;35(1):63-9. [PMID: ] - PMC - PubMed
SURE 2009 {published data only}
    1. Chan JC, So WY, Yeung CY, Ko GT, Lau IT, Tsang MW, et al. Effects of structured versus usual care on renal endpoint in type 2 diabetes: the SURE study: a randomized multicenter translational study. Diabetes Care 2009;32(6):977-82. [MEDLINE: ] - PMC - PubMed
    1. Ko GT, Yeung CY, Leung WY, Chan KW, Chung CH, Fung LM, et al. Cost implication of team-based structured versus usual care for type 2 diabetic patients with chronic renal disease. Hong Kong Medical Journal 2011;17 Suppl 6:9-12. [MEDLINE: ] - PubMed
Tan 2019 {published data only}
    1. Tan E, Khoo J, Gani LU, Malakar RD, Tay TL, Tirukonda PS, et al. Effect of multidisciplinary intensive targeted care in improving diabetes mellitus outcomes: a randomized controlled pilot study - the Integrated Diabetes Education, Awareness and Lifestyle modification in Singapore (IDEALS) Program. Trials 2019;20(1):549. [PMID: ] - PMC - PubMed
Tsay 2003 {published data only}
    1. Tsay SL. Self-efficacy training for patients with end-stage renal disease. Journal of Advanced Nursing 2003;43(4):370-5. [MEDLINE: ] - PubMed
Tsay 2004c {published data only}
    1. Tsay SL, Hung LO. Empowerment of patients with end-stage renal disease--a randomized controlled trial. International Journal of Nursing Studies 2004;41(1):59-65. [MEDLINE: ] - PubMed
Tsay 2005 {published data only}
    1. Tsay SL, Lee YC, Lee YC. Effects of an adaptation training programme for patients with end-stage renal disease. Journal of Advanced Nursing 2005;50(1):39-46. [MEDLINE: ] - PubMed
Tsuji‐Hayashi 2000 {published data only}
    1. Tsuji-Hayashi Y, Fitts SS, Abeyta VA, Young BA, Blagg CR. The new dialysis version of the Dartmouth Coop Educational System: effectiveness in improving health status and quality of life [abstract no: A1294]. Journal of the American Society of Nephrology 2000;11(Sept):246A. [CENTRAL: CN-00583293]
Tuot 2018 {published data only}
    1. Tuot DS, McCulloch CE, Velasquez A, Schillinger D, Hsu CY, Handley M, et al. Impact of a primary care CKD registry in a US public safety-net health care delivery system: a pragmatic randomized trial. American Journal of Kidney Diseases 2018;72(2):168-77. [PMID: ] - PMC - PubMed
Ueki 2021 {published data only}
    1. Ueki K, Sasako T, Okazaki Y, Miyake K, Nangaku M, Ohashi Y, et al. Multifactorial intervention has a significant effect on diabetic kidney disease in patients with type 2 diabetes. Kidney International 2021;99(1):256-66. [PMID: ] - PubMed
Woolf 2017 {published data only}
    1. Woolf K, Ganguzza L, Pompeii ML, Hu L, St-Jules DE, Jagannathan R, et al. Weight loss and self-efficacy in obese/overweight patients with type 2 diabetes and chronic kidney disease in a lifestyle intervention pilot study [abstract no: 970.8]. FASEB Journal 2017;31(1 Suppl 1):--. [EMBASE: 616960059]
Yalcin 2008 {published data only}
    1. Yalcin BM, Karahan TF, Ozcelik M, Igde FA. The effects of an emotional intelligence program on the quality of life and well-being of patients with type 2 diabetes mellitus. Diabetes Educator 2008;34(6):1013-24. [MEDLINE: ] - PubMed
Zhu 2021 {published data only}
    1. Zhu J, Chen M, Pang Y, Li S. Impact of lifestyle education for type 2 diabetes mellitus: protocol for a randomized controlled trial. Medicine 2021;100(1):e24208. [PMID: ] - PMC - PubMed

References to studies awaiting assessment

NCT00782847 {unpublished data only}
    1. Merker LF. Evaluation study for the programme DiaNe for people with diabetic nephropathy (DiaNe) [A prospective controlled randomized multicenter trial to evaluate the effect of a structurized multifactorial behavior modifying consultation and support programme DiaNe for people with diabetic nephropathy]. https://clinicaltrials.gov/study/NCT00782847 (first received 31 October 2008).
Suvamat 2023 {published data only}20230830001
    1. Suvamat J, Powwattana A, Thaingtham W, Pichayapinyo P, Boonlue S. Effectiveness of program to slow progression of chronic kidney disease among T2DM with HT with CKD 3 in the community: a randomized controlled trial. Journal of Primary Care & Community Health 2023;14:21501319231210619. [DOI: 10.1177/21501319231210619] [PMID: ] - DOI - PMC - PubMed

References to ongoing studies

NCT03413215 {unpublished data only}
    1. Khoo J. Effects of multidisciplinary intensive targeted care in improving diabetes outcomes: a pilot study in Singapore (IDEALS) [Effects of multidisciplinary intensive targeted care in improving diabetes outcomes: a randomized controlled pilot study - the integrated diabetes education, awareness and lifestyle modification in Singapore (IDEALS) program]. https://clinicaltrials.gov/study/NCT03413215 (first received: 29 January 2018). - PMC - PubMed

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References to other published versions of this review

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