Types of participants
This review will consider studies that include adult patients aged 18 years and over who have been clinically diagnosed with compensated or decompensated liver cirrhosis. Studies investigating non-liver disease-related cirrhosis, the use of herbal medications, pre- and post-liver transplant and/or hepatocellular carcinoma patients, include non-cirrhotic patients, inpatient data, non-liver-related co-morbidities, patients undergoing interferon therapies and clinical trial studies investigating the use of medications or alternate interventions on HRQOL will be excluded.
Types of intervention(s)/phenomena of interest
Studies will be included if they have assessed the impact of the following physical and psychological factors on the HRQOL of patients. The physical factors will include but not limited to esophageal varices, ascites, hepatic encephalopathy, jaundice, irregular sleep patterns, muscle cramps, pruritus, fatigue, impaired mobility, breathlessness, abdominal discomfort, gastrointestinal symptoms, muscle wasting and pitting edema. The psychological factors include stress, depression and anxiety.
Types of outcomes
Studies will be included if they have objectively measured HRQOL including measuring any of the following domains: physical, social and family wellbeing; and emotional, psychological and functional wellbeing.
Studies will be included if quality of life has been measured using objective scales including but not limited to Liver Disease Quality of Life 1.0 (LDQOL), Short Form 36 Profile (SF-36), Chronic Liver Disease Questionnaire (CLDQ), Liver disease symptom index 2.0 (LDSI 2.0), Hepatitis Quality of Life Questionnaire.
Types of studies
This review will consider experimental study designs including prospective and retrospective cohort studies and descriptive studies for inclusion.
The search strategy aims to find both published and unpublished studies.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 the Cochrane Library, MEDLINE and CINAHL will be undertaken, followed by analysis of the text words contained in the titles and abstracts, 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 lists of all identified reports and articles will be searched for additional studies. Studies published in the English language will be considered for inclusion in this review due to limited resources. Studies published from 1999 will be considered for inclusion in the review as this is when HRQOL data specific to chronic liver disease and excluding chronic hepatitis C were first reported.30-32
The databases to be searched include: Medline, CINAHL, Embase, Cochrane Central Register of Controlled Trials (CENTRAL) and Scopus
The search for unpublished studies will include: ProQuest Dissertation & Theses and MedNar
Initial key words to be used will be:
Quality of life
Health related quality of life
Assessment of methodological quality
Quantitative papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer.
Quantitative data will be extracted for papers included in the review using the standardized data extraction tool from JBI-MAStARI (Appendix II). The data will be extracted independently by one author and checked by a second author. The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives. Authors of primary studies will be contacted for missing information or to clarify unclear data.
Quantitative papers will, where possible, be pooled in statistical meta-analysis using JBI-MAStARI. All results will be subject to double data entry. Effect sizes expressed as odds ratios (for categorical data) and 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 and also explored using sub-group analyses based on 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.
Conflicts of interest
No conflicts of interest can be identified or foreseen in relation to this proposed systematic review.
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Appendix I: Appraisal instruments
MAStARI appraisal instrument
Appendix II: Data extraction instruments
MAStARI data extraction instrument