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SYSTEMATIC REVIEW PROTOCOLS

Multidisciplinary management of diabetic kidney disease: a systematic review protocol

Helou, Nancy MS, RN; Dwyer, Andrew MScN, NP; Burnier, Michel MD; Shaha, Maya PhD; Zanchi, Anne MD

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JBI Database of Systematic Reviews and Implementation Reports: July 2014 - Volume 12 - Issue 7 - p 192-203
doi: 10.11124/jbisrir-2014-1543
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Abstract

Inclusion criteria

Types of participants

This review will consider studies that include:

1. Adults aged 18 years old

2. Diagnosed with type 1 or type 2 diabetes, according to the WHO criteria (WHO 2006): fasting plasma glucose ≥ 7.0 mmol/L and two hour plasma glucose ≥ 11.1 mmol/L.35

3. Diagnosed with CKD stage one to five, based on the urine albumin excretion ratio (UAER) according to the KDOQI 2007 criteria.36

Types of intervention(s)/phenomena of interest

This review will consider studies that include the following types of interventions:

1. Multidisciplinary management programs or programs that include an approach or intervention from more than one medical or allied health discipline (for example nurses, pharmacists, dieticians, or health educators) for the management of DKD, that aims to prevent the decline in kidney function, control the progression of kidney disease, improve glycemic and/or blood pressure control or improve patients' quality of life.

2. Comparison of multidisciplinary programs with any other treatment (including standard disease management approaches) or with retrospective (historical) outcome data.

3. Structured care plans provided by more than one healthcare discipline including physicians, nurses, pharmacists, dieticians, or health educators.

4. Multidisciplinary intervention conducted in an outpatient setting defined as an ambulatory clinic, home care/work place setting or a combination of both (hybrid).

Types of outcomes

This review will consider studies that include the following health-related outcomes: in the absence of validated objective or subjective self-report instruments, unvalidated self-report data will be included as the lowest level of data assessing outcomes among DKD patients.

A. Primary clinical outcomes:

1. Changes or decline in kidney function evaluated through the measurement of creatinine clearance and/or glomerular filtration rate and/or serum creatinine and/or proteinuria.

2. Incidence of kidney failure evidenced by the start of renal replacement therapy either by hemodialysis or peritoneal dialysis.

B. Primary patient reported outcomes:

1. Generic or specific health-related quality of life (including assessment of depression, anxiety and coping using validated instruments).

2. Patient self-care abilities measured by objective validated instruments or self-report.

3. Adherence to treatment recommendations or goals, such as adherence to medication taking, increased physical activity, dietary modifications or any other treatment assessed using objective measures, validated instruments or self-report.

C. Secondary clinical outcomes:

1. Mortality rates secondary to DKD.

2. Changes in blood pressure control, glycemic control or lipid profile.

3. Incidence of cardiovascular disease or events.

D. Secondary patient reported outcomes:

1. Level of knowledge about diabetes and/or DKD, evaluated using objective measures or self-report.

2. Level of patient empowerment or self-efficacy assessed using objective measures or self-report.

3. Generic (unvalidated patient-reported outcomes related to satisfaction with care) or specific instruments measuring patient satisfaction with care (previously validated metrics/questionnaires).

4. Patient healthcare utilization measured objectively or through self report.

Types of studies

This review will consider any experimental study design including randomized controlled trials, randomized cross-over and quasi-experimental studies, before and after studies and non-randomized controlled trials, for inclusion.

Search strategy

The search strategy aims to find both published and unpublished studies. A three-step search strategy will be utilized in this review. An initial limited search of MEDLINE and CINAHL will be undertaken, followed by analysis of the text words contained in the title and abstract and of the index terms used to describe the article. A second search using all identified keywords and index terms will then be undertaken across all included databases. Thirdly, the reference lists of all identified reports and articles will be searched for additional studies. Reviewers are fluent in English, German and French. Therefore, studies published in these languages will be considered for inclusion in this review. Studies published from the time of the respective database inception to July 2014 will be considered for inclusion in this review.

The databases to be searched include:

1. Medline using MeSH terms and keywords together. MeSH terms (Diabetic nephropathies, patient care team, collaborative approach, multidisciplinary).

2. CINAHL using Subject Headings terms and keywords together. Subject Headings terms (Diabetic nephropathies, patient care teams).

3. Embase using EMBASE terms and keywords together.

The search for unpublished studies will include:

1. Searching clinical trials registry platforms namely:

International clinical trials registry platform search portal: www.who.iht/trialsearch

International standard randomized controlled trial number register: www.controlled-trials.com/isrctn

European Medicines Agency: www.emea.europa.eu/index/indexh1.htm

Australian clinical trials registries: www.australianclinicaltrials.gov.au

UK clinical trial gateway: www.controlled-trials.com/ukctr

2. In the event that unpublished studies are retrieved, letters will be sent to the corresponding author requesting further information and/or data from the identified studies.

Initial keywords to be used will be:

Diabetic nephropathies; Diabetic Kidney Disease; multidisciplinary; interdisciplinary; patient care team; collaborative approach; nurse-led

Assessment of methodological quality

Papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using the standardized critical appraisal instrument, the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) (Appendix V). Any disagreements that arise between the reviewers will be resolved through discussion or with a third reviewer.

Data collection

Data will be extracted from papers included in the review using the standardized data extraction tool from JBI-MAStARI (Appendix VI). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives.

Data synthesis

Quantitative data will be pooled where possible, for statistical meta-analysis using JBI-MAStARI. Effect sizes (expressed as an odds ratio for categorical data) and weighted mean differences (for continuous data) with a 95% confidence interval will be calculated for analysis. Results will be tested for heterogeneity using Chi-square and in the case of significant heterogeneity a random effects meta-analysis will be conducted. In circumstances whereby statistical pooling is not appropriate or possible, the findings will be presented using narrative and tabular form.

In the event that multiple combinations are identified in the literature related to composition of the multidisciplinary team or the structure of multidisciplinary interventions, the authors will construct tabular matrices depicting the variable results for each respective combination (for example group composition or structure of treatment plan).

Conflicts of interest

Authors disclose no conflict of interest.

Acknowledgements

The authors address recognition and gratitude to Fondation Leenaards and the University of Applied Sciences of Western Switzerland for their funding allowing this review to be conducted.

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                                Appendix I: Appraisal instruments

                                MAStARI appraisal instrument

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                                Appendix II: Data extraction instruments

                                MAStARI data extraction instrument

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                                Keywords:

                                Diabetic nephropathies; Diabetic Kidney Disease; multidisciplinary; interdisciplinary; patient care team; collaborative approach; nurse-led

                                © 2014 by Lippincott williams & Wilkins, Inc.