Table 2:
Impact of interventions on patient outcomes, and quality appraisal of studies using the Joanna Briggs Appraisal Tool | ||||||||||
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Study (country) | Study design | Control | Risk of bias: Joanna Briggs Critical Appraisal | Primary outcome measure | Conclusions | Random sequence generation | Blinding of outcome assessment | Incomplete outcome data | Selective reporting | Other bias |
Williams (2012) | Feasibility study for double-site, single-blinded longitudinal RCT Randomization: stratified by ethnicity, then randomized by age and gender using a purpose-built randomization sequence computer program |
Routine care of outpatient clinics and primary care | • Did not report if groups had similar characteristics at baseline • Unclear whether outcomes were measured in a reliable way (did not include number of raters, training or raters or inter/intra-rater reliability) • Did not provide quantitative data of results (only qualitative summary sentences) |
Medication self-efficacy and adherence | No significant difference in medication self-efficacy, medication adherence, general wellbeing, healthcare utilization and routine clinical laboratory surrogate measures at each data collection time point | |||||
Hotu (2010) | RCT Randomization: unspecified |
Routine family doctor and/or renal/diabetes hospital clinical care | • Did not specify method of randomization | Changes in office BP (systolic and diastolic) | Community care patients had a significantly greater reduction in systolic BP at 12 months when compared with the control group | |||||
Song (2009) | Feasibility study for a RCT Randomization: permuted block randomization using sequential, opaque, numbered envelopes |
Routine care of a once-only session with a social worker urging patients to complete an Advanced Care Directive | • Overall rigorous study design: described method of randomization and loss to follow-up | Feasibility: attrition rates comparison between intervention/control arm, and the median and mean minutes for the nurse to complete the intervention Acceptability: Patient–Clinician Interaction Index scores at baseline, 1 week and 3 months |
Feasibility: attrition was similar between both groups Acceptability: quality of communication scores of both patients and surrogates were higher in the intervention group at all time points |
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Park (2014) | Randomized crossover study Randomization: unspecified |
Audio-recorded BP education | • Did not specify method of randomization, or if there was the loss of any study participants to follow-up | Changes in BP (systolic, diastolic, mean arterial pressure), heart rate and muscle sympathetic nerve activity | There was a significantly lower systolic, diastolic, mean arterial pressure and heart rate in the intervention group compared with controls. There was a significantly greater reduction in MSNA in the intervention group compared with the control intervention. There was no difference in respiratory rate between groups |
Quality appraisal of studies using meta quality appraisal tool | |||||
Study | Study design | Relevancy | Reliability | Validity | Applicability |
Akhtar (2014) | Narrative description of intervention development and implementation process | Use of a cultural and health improvement officer for South Asian patients in Bradford, UK | • The aim of the intervention is not clearly outlined • Clearly defined role of the cultural health officer • No reporting of the inclusion/exclusion criteria of the participants eligible to work with the health officer • Did not cite ethics approval |
There is comprehensive discussion of the role of the health officer rationalized by the unique health needs of the South Asian CKD population There is no statistical analysis of impact of the intervention. There are two anecdotal case studies of the impact of a health officer on patient care |
The role of the healthcare officer is comprehensively defined and encompasses not only CKD management, but also holistic wellbeing, immigration and social services |
Barrett (2015) | Narrative description of intervention development and implementation process | Provision of community nephrology clinics at an Aboriginal Medical Service in rural NSW, Australia | • Clearly states aims • No reporting of inclusion/exclusion criteria or pre-intervention rates of CKD • Methods of identifying undiagnosed CKD patients clearly described • No statistical analysis of data • Did not cite ethics approval |
Methodology for identifying CKD patients appropriate to aim Methodology addressing secondary aims of community awareness, education programs and management plans insufficiently described Potential sampling bias in methodology as CKD was only tested for in those with specific risk factors |
The study highlights the role of upstream chronic health disease in CKD development. Methods of identifying new CKD patients were appropriate to a vulnerable and geographically difficult to access high health needs population There was insufficient description of how or why the aims, methodology or interventions of this study are culturally targeted and tailored to the Durri Aboriginal people |
Paterson (2010) | Narrative case report of intervention development process | Co-design of a health resources toolkit for Elsipogtog First Nation's people living with CKD | • Clearly states aims • Methods of intervention development, including cultural targeting and tailoring well characterized • No pre- and post-test measures of success of the intervention • Study approved by an ethics board |
Comprehensive description of the methodology of intervention description, from stakeholder interviews, identifying key themes and the creation and implementation of the educational resource The methodology is appropriate for the aims There is no evaluation of the impact of the intervention on patient clinical and/or psychosocial outcomes |
Recognized governing principles of Community Based Participatory Research Formed ethical partnerships with local communities, including creating a Memorandum of Understanding Thorough description of the intervention creation that recognizes both cultural targeting and tailoring. Considers accessibility and practical aspects of implementation during intervention design |
Tracey (2013) | Narrative description of intervention development and implementation process | Nursing-managed kidney disease program in rural Aboriginal communities in Western Australia | • Clearly states aims • No reporting of inclusion/exclusion criteria of participants, or of their baseline demographics • There is description of the program structure, but no justification of the cultural appropriateness, targeting and tailoring of intervention development • Did not cite ethics approval |
There is comprehensive justification of how the intervention methodology overcomes the practical barriers of providing greater access to care There may be some reporting bias. There are some descriptive statistics of pre- and post-intervention measures, but not for all of the primary aims. It is unclear the number of people the intervention was trialled in, which may limit external validity |
The intervention forms partnerships with multiple levels of allied health, government and other organisations The intervention has not been tested for acceptability to the local Indigenous Australian population |
Verseput and Piccoli (2017) | Narrative description of intervention development process | A visual aid educational tool teaching renal diet principles for illiterate or non-English-speaking South Africans | • Clearly states aims • No reporting of inclusion/exclusion criteria or pre-intervention knowledge of renal diet • Methods of intervention development were well described, including rationale for the content and format • No statistical analysis of data • Did not cite ethics approval |
Comprehensive description of the methodology of intervention description, including an iterative design process influenced by patient feedback There may be sampling bias and a limited external validity as it is unclear of who (age, gender, demographics) the intervention was trialled in |
This intervention comprehensively justified the content and format of education. There was some tailoring to different genders after feedback from consumers |
Conway (2018) | Narrative description of intervention development process and qualitative evaluation | A South Australian Mobile Dialysis Truck, which visits remote communities for one to two week periods to improve access to dialysis for remote Indigenous Australian communities | • Clearly states aim • Cites ethics approval • Minimal description of participant recruitment process • No description of exclusion criteria • Methods for qualitative interviews clearly described • Provides qualitative evaluation of intervention |
There may be sampling bias and a limited external validity as the study does not report the baseline demographics of participants The methodology is appropriate for the aims There is qualitative (but no quantitative) evaluation of the impact of intervention on patient quality of life and satisfaction with service provision |
There is comprehensive description of how an iterative interview schedule was created and adapted to the cultural concept of ‘yarning’. The qualitative evaluation of intervention, including participant priority-setting of outcome measures, may be useful for future studies |
Beecham (1995) | Narrative description of a case report | A social worker provides a case report of the cultural accommodations made for a young, Mexican-American patient living with CKD | • Does not clearly state aims of social work intervention • Does not cite ethics approval • Narrative description of the strategies employed to engage a culturally diverse patient • Provides some patient qualitative feedback |
There is a small sample size of one person, lending to sampling bias and limited external validity The demographics of the participant, apart from cultural background, are not reported There is minimal qualitative, and no quantitative evaluation of the impact of intervention on the patient's care |
The case report promotes patient autonomy, participation in decision-making and promotes the co-existence of both Western and traditional Mexican Cuarandero's role in health and wellbeing |
Cervantes (2019) | Single-arm prospective study | A peer navigator program for Latinx patients on haemodialysis, providing assistance with advance care planning, care coordination, and counseling about the importance of diet and mental health | • Clearly states objectives • Cites ethics approval • Reports inclusion and exclusion criteria • Baseline demographics of participants are reported • There are some descriptive statistics of impact of intervention on patient reported quality of life |
There is some description of how themes were delineated, and the training peer navigators received There is minimal attrition bias. The study used validated questionnaires and scales. There is some reporting of descriptive statistics of impact of the intervention on patient reported outcomes. There is no reporting of pre- and post-test measures |
The intervention justified format and content of the peer navigator program. The combination of quantitative (descriptive statistics) and qualitative (patient feedback) evaluation may be useful in further understanding acceptability and feasibility of the interventionF |
BP, blood pressure; MSNA, muscle sympathetic nerve activity.