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Effectiveness, cost effectiveness, acceptability and implementation barriers/facilitators of chronic kidney disease management programs and models of care for Aboriginal and Torres Strait Islander Australians: a mixed methods systematic review protocol

Reilly, Rachel; Evans, Katharine; Gomersall, Judith; Gorham, Gillian; Warren, Steven; O'Shea, Rebekah; Peters, Micah; Brown, Alex; Cass, Alan

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JBI Database of Systematic Reviews and Implementation Reports: April 2015 - Volume 13 - Issue 4 - p 65-86
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Review objectives and questions

The objective of this mixed methods review is to synthesize quantitative, economic and qualitative evidence on chronic kidney disease (CKD) management programs and models delivered to Aboriginal and Torres Strait Islander Australians. Studies with Indigenous participants from New Zealand and Canada will also be considered because similar persistent patterns of health inequities have arisen in these countries as a result of a shared colonial history, despite vast differences in timing and location.1,2 Also, there are geographic and demographic similarities, such as remoteness from health services and poor engagement due to differing language, culture and concepts of health and illness from the dominant culture. These socio-demographic circumstances are associated with higher burdens of chronic disease and poorer health outcomes.3,4

The intention of this systematic review is to inform CKD program design, practice and service delivery to Aboriginal and Torres Strait Islander populations in Australia.

The questions to be addressed in the review are:

  1. What is the effectiveness of programs/models in relation to outcomes, including, though not limited to, the management of “indicators to target” such as blood pressure control, the delayed progression of kidney disease/time to dialysis, and quality of life?
  2. What are the costs and costs relative to benefits of the programs/models from the perspectives of individual patients and their families, the primary health services that deliver them, tertiary health services and society as a whole?
  3. What do patient and provider experiences of programs/models reveal about the acceptability of programs, as well as barriers and enablers of implementation?


Chronic kidney disease, and associated chronic illnesses including heart disease, stroke and diabetes, constitutes half of the gap in life expectancy between Indigenous and non-Indigenous Australians.5 Chronic kidney disease occurs more frequently and in younger age groups amongst Aboriginal and Torres Strait Islander people, with rates three to five times the national average in urban areas and up to 30 times the national average in remote areas.11 Mortality rates are correspondingly high with reports from Queensland, South Australia, Western Australia and the Northern Territory listing CKD as a primary or associated cause of death in 16% of Indigenous deaths, a rate at least three and a half times higher than the national average.9 Similarly, a disproportionately high burden of CKD has been found among First Nations people in Canada6,7 and Maori people in New Zealand.8

The scale of the social and economic cost of the progression of CKD to end stage kidney disease (ESKD) in Indigenous Australians is reflected in rates of hospitalization for regular dialysis that are 11 times higher than those recorded for non-Indigenous Australians. Overall, regular dialysis accounts for more than 40% of all hospitalizations for Indigenous Australians.9 Further, the incidence of ESKD in Aboriginal and Torres Strait Islander Australians has more than doubled between 1991 and 2008 and is projected to increase by 130% from 2009 to 2020.10 Dialysis is expensive, invasive and leads to decreased quality of life, particularly for Aboriginal people living in rural and remote locations, who often have to leave their homes for extended periods and/or travel long distances to access treatment.15,16

High rates of clinical and environmental risk factors, including low birth weight, high blood pressure, obesity, smoking, poor nutrition and socioeconomic disadvantage, contribute to the higher burden of CKD in Indigenous populations.10 Reducing this burden will require primary prevention strategies across the life course.11 At present, limited access to appropriate health care in many communities and poor uptake of adult health checks, which partially screen for CKD, present barriers to Aboriginal and Torres Strait Islander Australians accessing timely and appropriate health care for CKD.5

While primary prevention and population based screenings are important health priorities for Indigenous populations as they are for the general population, this review focuses on identifying and synthesizing the evidence on programs and models of care for those who have established CKD but have not reached end-stage, or kidney failure, at which point dialysis or transplant are required (see Figure 1). The goals in management of CKD include the reduction of cardiovascular risk particularly through reducing blood pressure to target levels, early detection and appropriate management of complications, avoidance of nephrotoxic medications, timely referral to a nephrologist, health education and support for diet and other lifestyle changes.12

Figure 1: Focus of this review in relation to the prevention and management pathway for CKD
Figure 1: Focus of this review in relation to the prevention and management pathway for CKD

For western, non-Indigenous populations, a recent quantitative systematic review found that care provided by a multidisciplinary team, compared to standard medical care, delays the progression of CKD for adults in the pre-dialysis phase of the condition.13 The four studies included in that review were conducted within the United Kingdom, United States and Canada and focused on education as the primary preventative strategy. While some aspects of the models shown to be effective in non-Indigenous populations may be effective and acceptable for Aboriginal and Torres Strait Islander populations, the evidence suggests that they should not be wholly transferred. For example, the application of self-management approaches to socially disadvantaged populations has been criticized on the basis that they do not take into account the everyday challenges faced by these population groups.14,15 In addition, the individualism of western self-management frameworks sits uncomfortably with the more relational social and cultural context of Indigenous people.16 Further, the ability to access, understand and utilize health information, also known as health literacy, is known to be lower in culturally and linguistically diverse and disadvantaged populations.17 Health literacy is affected by many factors including language barriers, low educational attainment levels, lack of familiarity with medical terminology and differing styles of learning.

Research has identified that how and where communication occurs affects how information is received and internalized, with patients clearly preferring settings that align with their worldview. Ideally, health education should result in a shared understanding and involve two way communication, rather than a one way imparting of information.18 This suggests that programs and models of care tailored to the particular needs and context of Indigenous people may be more effective. In order to effectively and appropriately meet the needs of Indigenous people with CKD, programs and models need to fit the social and cultural contexts of Indigenous populations, with a reduced emphasis on the delivery of care within a medical setting.

A recent review of cost-effectiveness of diabetes, hypertension and CKD management programs, conducted in the general Australian population, found that primary care-based screening for CKD and its major risk factors, followed by intensive treatment, can lead to improved health outcomes that are also likely to be good value for money.19 The Central Australia Renal Study undertook economic analyses of care provided to Aboriginal people in that region and found that the best value for money would be attained by resourcing prevention efforts to achieve a 20% reduction in the projected rise of ESKD by 2020.20,21,22

A preliminary search of the Joanna Briggs Library of Systematic Reviews, the Cochrane Library, CINAHL, PubMed and PROSPERO revealed that there is not currently a systematic review focused on the proposed topic (either published or underway). This review was conducted as part of a larger collaborative research project designed to meet the need of policy-makers for evidence to inform the building of more effective, efficient and appropriate health care programs and models of care. The mixed method design and questions to be addressed in the review arose from consultation with researchers working on this broader project. This review's findings will be used to highlight the common elements and features of successful programs and provide an evidence informed understanding of key aspects of design and implementation that facilitate success.

This review will consider published and unpublished quantitative, economic and qualitative evidence and use the Joanna Briggs Institute mixed method segregated approach for conducting systematic reviews. There will be two distinct phases in the review process. In phase 1 the quantitative, economic and qualitative evidence relevant to the review questions will be identified, assessed and synthesized in a segregated manner, generating three sets of distinct findings. In phase 2, the results from the three segregated components of the review will be drawn together in an aggregative synthesis.


Indigenous: For the purpose of this protocol and systematic review, the term “Indigenous” refers to Aboriginal and Torres Strait Islander Australians, Maori in New Zealand and First Nations people in Canada. Within each of these population groups, there are unique regional and cultural names that are the preferred mode of identifying specific groups. Where possible throughout the systematic review, these names will be used when referring to particular Indigenous subgroup participants of studies.

Chronic kidney disease (CKD): This refers to all kidney conditions resulting in kidney damage and/or reduced kidney function, regardless of underlying cause. It is categorized into five stages according to the degree of reduced function. Stage of kidney disease is commonly diagnosed clinically by the estimated glomerular filtration rate (eGFR). This is measured by using a formula requiring age, gender and serum creatinine level in the blood.10

Acceptability: The degree to which a program or model of care is considered acceptable and appropriate by the consumers of care, according to their cultural, social, environmental, geographical, physical and economic needs and preferences.

Barriers and facilitators: Any social, economic, cultural, organizational, environmental or personal factor that inhibits or supports access and/or adherence to the health care treatment or program.

Effectiveness: The effect of the particular program or model of care on the defined outcomes under “real-world” conditions. This is different from the concept of efficacy, which refers to the effect of a program or model of care under ideal conditions.

Cost-effectiveness, cost-benefit and cost-utility analysis: These methods are commonly applied to measure and compare the resource use/costs relative to the benefits/health outcomes/impact of an intervention and comparator. Cost minimization (which assumes benefits are identical for the intervention and comparator) is another method. The approaches are similar (at least in principle) with respect to how they measure cost, but differ in their conceptualization of benefit. The cost benefit approach measures benefits in monetary units, the cost effectiveness approach in natural/clinical outcome units, and the cost utility in quality adjusted life years (QALYS) or disability adjusted life years (DALYS).

Outpatient setting: Care provided to people who are not admitted to hospital. It includes outpatient clinics at hospitals, secondary settings, primary healthcare or community settings and includes outreach services to primary health facilities by multidisciplinary and specialist services.

Program: For the purpose of this review, a program refers to a health sector led sequence of actions or outline of the way a system or service will function, with specifics such as roles and responsibilities, expected expenditures and outcomes defined.

Model of care: a multifaceted concept, which broadly defines the overarching design for the provision of a particular type of health care service. It outlines how healthcare is delivered across clinical streams and patient flow continuums.23–25

Inclusion criteria

Types of participants/population

  • Indigenous people (adults 18 years or older) of Australia, Canada and New Zealand diagnosed with CKD
  • AND
  • Receiving care in an outpatient setting.

Studies including participants of other ethnicities (or Australian, Canadian and New Zealand populations as a whole), other ages or with additional chronic diseases but where either: the majority of participants match the inclusion criteria; or the results are reported separately for the participants matching the inclusion criteria, will be considered for inclusion.

In the qualitative component of the review studies including participants who are Indigenous or non-Indigenous family members, significant others, carers and/or health care providers in Australia, New Zealand and Canada reporting on experiences of health care programs/models matching the inclusion criteria will be considered, in addition to studies whose participants match the above criteria.

Types of intervention(s)/phenomena of interest

Studies reporting data on health sector led management programs and models of care explicitly designed to manage, slow progression or otherwise improve the lives of people with CKD will be considered for inclusion.

Studies evaluating renal replacement therapy (dialysis or transplant) will be excluded.

With respect to comparators to be considered in the quantitative effectiveness and economic review components, all health care program/model alternatives will be considered, including comparisons with no CKD management program, usual care, non-Indigenous people or all ethnicities in Australia, New Zealand and Canada.

The qualitative component of the review will consider studies that investigate health care worker and/or patient experiences/perceptions of delivery of CKD management programs or models of care to participants matching the inclusion population, in relation to though not limited to, acceptability, patient satisfaction, engagement/participation, self-management and barriers and facilitators of effective CKD management.


All CKD programs or models of care delivered in the outpatient setting will be considered.

Types of outcomes

In relation to effectiveness and cost effectiveness, studies will be considered for inclusion if they measure outcomes including, but not limited to:

  • Change in clinical indicators such as HbA1c levels and blood pressure control or evaluate outcomes such as survival and rates of progression to ESKD
  • Quality of life, acceptability and satisfaction
  • Psychosocial and behavioural factors including, but not limited to: ability to self-manage, adherence, depression, anxiety, self-efficacy and service utilization measured with psychometric or other survey instruments
  • Barriers and facilitators to implementation
  • Costs, and/or costs relative to benefits and/or savings associated with implementing the program/model, only implementing part of the model/program, or doing nothing (no CKD program).

All measures for the range of included outcomes will be considered and, where relevant, limitations of the measures used for example, when an instrument has not been validated for use with Indigenous populations, will be reported.

Types of studies

Studies reporting on primary research will be considered for inclusion.

Studies to be considered in the element of the review addressing the question of effectiveness are:

  • Randomised controlled trials (RCTs)
  • Non randomised controlled trials
  • Observational studies:
    • Retrospective and prospective cohort studies
    • Case control studies
    • Health service studies
    • Health service evaluations
    • Analytic cross sectional studies
    • Descriptive epidemiological study designs

In the component of the review addressing the questions about costs, savings and costs relative to benefits economic evaluations and costing studies (including model based studies)

  • All costing and economic evaluation study designs will be included.
  • Studies based on empirical data only, or empirical data and modelling will be considered.

The qualitative review component will consider all qualitative study designs including descriptive, ethnography, phenomenology, grounded theory studies, action research and evaluations including developmental evaluation.

If mixed method studies are identified they will be considered for inclusion.

Studies that are systematic reviews, solely prevalence studies or epidemiological studies showing relationships between indicators or risk factors in the absence of a specific program or model of care will not be considered for inclusion.

Search strategy

The search strategy will seek both published and unpublished studies written in English. The date range will be restricted to publications between 2000 and 2014 because technology and data collection in health care has advanced to such an extent that earlier findings are likely to be less relevant in terms of effectiveness, dollar values for cost evaluations and prevailing government strategy, policy and funding arrangements.

A three step search strategy will be used. An initial limited search of PubMed 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 articles. A second search using all identified keywords and index terms will then be undertaken across all included databases. Thirdly, the reference list of all identified reports and articles will be searched for additional studies.

The following databases will be searched for published studies:




ATSIHealth via Informit online

Web of Science


Social Science Citation Index

APAIS Health databases

Australian Indigenous Health InfoNet

Primary Health Care Research and Information Service (PHCRIS)

The search for unpublished studies will include:

Mednar and Trove

Google Grey

OCLC WorldCat Dissertations and Theses

Canada Theses Portal

Websites of relevant organizations in each country including Kidney Health Australia, Kidney Health New Zealand and The Kidney Foundation of Canada

Other specific resources to be searched are:

Australian Institute of Torres Strait Islander Studies

llt.Search (Lowitja Institute)


World Health Organization

Hand searching will include Pimatisiwin: Journal of Aboriginal and Indigenous Community Health and reference lists of relevant published systematic reviews.

In addition, relevant experts will be consulted.

Initial keywords to be used will be:

Population of interest

(Australia[mh] OR Australia*[tw] OR Canada[mh] OR Canad*[tw] OR New Zealand[mh] OR New Zealand[tw]) AND (Oceanic ancestry group[mh] OR American Native continental ancestry group[mh] OR aborig*[tw] OR indigenous[tw] OR Torres Strait Island*[tw] OR Koori*[tw] OR Tiwi[tw] OR Maori[tw] OR First Nation*[tw] OR American Indian*[tw])

Problem of interest

kidney diseases[mh] OR chronic disease[mh] OR chronic kidney[tw] OR chronic renal[tw] OR predialysis[tw] OR pre dialysis[tw] OR albumin creatinine ratio[tw] OR estimated glomerular filtration rate[tw] OR diabetic nephropath*[tw]


disease management[mh] OR health services, indigenous[mh] OR rural health[mh] OR rural population[mh] OR rural health services[mh] OR preventive health services[mh] OR community networks[mh] OR delivery of health care[mh] OR health planning[mh] OR intervention[tw] OR management[tw] OR service*[tw] OR model*[tw] OR program*[tw] OR multidisciplinary[tw] OR co ordination[tw] OR coordination[tw] OR integrated[tw] OR transdisciplinary[tw] OR participatory[tw] OR community[tw] OR care[tw] OR prevent*[tw] OR health education[tw] OR health promotion[tw] OR exercise[tw] OR rural[tw] OR outreach[tw] OR remote[tw] OR focus group*[tw] OR ambulatory[tw] OR general practice[tw] OR clinic[tw] OR tertiary[tw] OR primary[tw] OR outpatient[tw] OR telemedicine[tw]

Assessment of methodological quality

Methodological quality of studies selected for retrieval will be assessed by two independent reviewers prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute (JBI).

Quantitative papers will be assessed using the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) (Appendix I). Economic papers will be assessed using the JBI Actuari Critical Appraisal tool (JBI-Actuari) (Appendix III). If they include a modeling element, they will also be appraised using the Philips et al.26 tool for appraising decision analytic models. Qualitative papers will be assessed using the Joanna Briggs Institute Qualitative Assessment and Review Instrument (JBI-QARI) (Appendix II).

Any disagreements that arise between the reviewers will be resolved through discussion or with a third reviewer.

Data Extraction

Stage 1 data extraction

Quantitative, economic and qualitative data will be extracted from papers included in the review using the slightly modified data extraction tools from JBI-MAStARI (Appendix IV), JBI-ACTUARI (Appendix V) and JBI-QARI (Appendix VI) respectively. The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives. In addition, a section of the data extraction tool will be added to record data on elements of programs that are identified as being effective in improving engagement with, uptake of and satisfaction with health services. Authors will be contacted where the need arises, for example to get access to publications or information not reported in the methods and results.

Stage 2 data extraction

Following segregated synthesis of the included quantitative, economic and qualitative evidence, the results of each single method synthesis included in the mixed method review will be extracted in numerical, tabular or narrative format. For example, for syntheses of quantitative data, this will consist of appropriate elements of the meta-analysis Forest plot or, where applicable, an evidence table; for qualitative reviews, it will consist of appropriate elements of the QARI-view table.

Data synthesis

Stage 1 data synthesis for each single-method synthesis

Quantitative papers data will, where possible, be pooled in statistical meta-analysis using JBI-MAStARI. All results will be subject to double data entry. For included studies on the effectiveness of health care programs/models effect sizes, expressed as odds ratio (for categorical data), weighted mean differences (for continuous data) and their 95% confidence intervals, will be calculated for analysis. Heterogeneity will be assessed statistically using the standard Chi-square test and also explored using subgroup analyses based on the different quantitative study designs included in this review. Where statistical pooling is not possible the findings will be presented in narrative form including tables and figures to aid in data presentation where appropriate. The evidence on barriers and facilitators will be described and synthesized in tabular and narrative form.

Economic data from quantitative papers will be synthesized using the “Dominance Ranking Matrix three by three framework” in JBI-ACTUARI, narrative and tables.

Qualitative research findings will, where possible, be pooled using JBI-QARI. This will involve the aggregation or synthesis of findings to generate a set of statements that represent that aggregation, through assembling the findings rated according to their quality, and categorizing these findings on the basis of similarity in meaning. These categories are then subjected to a meta-synthesis in order to produce a single comprehensive set of synthesized findings that can be used as a basis for evidence-based practice. Where textual pooling is not possible the findings will be presented in narrative form.

Stage 2 data synthesis for final mixed method synthesis

The findings of each single method synthesis included in this review will be aggregated (Figure 2). This will involve the configuration of the findings to generate a set of statements that represent that aggregation, through coding any quantitative data, attributing a thematic description to all quantitative and textual data; assembling all of the resulting themes from quantitative, qualitative and textual syntheses; and the configuration of these themes to produce a set of synthesized findings in the form of a theoretical framework, set of recommendations or conclusions.

Figure 2: the JBI model of mixed method synthesis
Figure 2: the JBI model of mixed method synthesis

Conflicts of interest

We declare that we have no conflicts of interest.


AB is supported by The Sylvia and Charles Viertel Senior Medical Research Fellowship. This project was partially funded by the Australian Government Department of Health. Thanks to Dr Karla Canuto, Assoc Prof Craig Lockwood and Prof Randall Faull for their constructive feedback on the protocol.


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Appendix I: MAStARI appraisal instruments


Appendix II: QARI appraisal instrument


Appendix III: JBI ACTUARI critical appraisal instrument


Appendix IV: MAStARI data extraction instruments


Appendix V: QARI data extraction instrument


Appendix VI: JBI ACTUARI data extraction instrument


chronic kidney disease; pre-dialysis; prevention; Aboriginal health

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