PROSPERO International prospective register of systematic reviews
Describing the outcomes of dysvascular partial foot amputation and how these compare to transtibial amputation: a systematic review protocol for the development of shared decision making resources
Michael Dillon, Stefania Fatone, Matthew Quigley
Michael Dillon, Stefania Fatone, Matthew Quigley. Describing the outcomes of dysvascular partial foot amputation and how these compare to transtibial amputation: a systematic review protocol for the development of shared decision making resources.
Available from http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42015029186
Describe the outcomes of dysvascular partial foot amputation
Compare the outcomes of partial foot and transtibial amputation
A comprehensive range of databases – MEDLINE, EMBASE, PsycINFO, AMED, CINAHL, ProQuest Nursing and Allied Health, and Web of Science – will be searched using MeSH terms as well as title, abstract, keywords relating to different amputation levels and outcomes of interest; specifically: incidence, prevalence and rate of amputation; rate of mortality, wound failure, dehiscence, time between index and ipsilateral reamputation; mobility, functional ability, activity and participation, quality of life, pain and psychosocial outcomes including depression and anxiety.
Articles that meet the inclusion criteria will be hand searched for relevant citations. A forward citation search using Google Scholar will be used to identify articles not yet indexed. Original research published in the English language after the 1st January 2000 will be included.
Types of study to be included
Inclusion: peer reviewed studies or original research.
Exclusion: editorials, letters, conference abstracts and opinion pieces. There are no other exclusions based on study design.
Condition or domain being studied
People with dysvascular partial foot or transtibial amputation.
People with dysvascular partial foot or transtibial amputation (with or without diabetes).
Definitions of transtibial and partial foot amputation will be consistent with the International Standards Organization (ISO) definitions and as such all levels of partial foot amputation, including toe amputation, will be included. By virtue of the ISO definition, ankle disarticulation (i.e., Through-ankle/Syme’s amputation) is not considered a partial foot amputation and as such, studies focused on this level of amputation will be excluded.
Outcomes include: incidence, prevalence and rate of amputation; rate of mortality, wound failure, dehiscence, time between index and ipsilateral reamputation; mobility, functional ability, activity and participation, quality of life, pain and psychosocial outcomes including depression and anxiety.
It is anticipated that the operational definitions and time points of the outcomes will vary across studies. As such, studies will be included irrespective of how the outcome has been defined or the time point at which it was measured. By way of example, studies reporting the rate of mortality will be included irrespective of the time point at which the outcome was measured (e.g., 1, 3 or 5 years post amputation).
Data extraction, (selection and coding)
Search results will be screened by one investigator based on review of the title and abstract. In cases where insufficient detail is reported in the abstract, the full-text article will be retrieved. Given that the inclusion criteria are unambiguous and do not require complex judgment, it will be unnecessary to routinely involve two investigators in the screening process. On occasion, a second opinion may be sought from another investigator and any disagreement will be resolved through discussion until consensus. Following screening based on title and abstract, full-text articles will be retrieved and independently reviewed by two investigators to confirm inclusion.
A data extraction spreadsheet will be developed in Microsoft Excel based on the Cochrane Consumers and Communication Review Group’s data extraction template to allow socio-demographic (e.g., age, sex, etiology, level of amputation, comorbidities), methodological (e.g., aim, study design, recruitment method, inclusion criteria), results (e.g., outcome measures) and quality appraisal details (using check list items and comments) to be systematically recorded.
The following outcomes will be extracted for people with dysvascular partial foot and transtibial amputation: incidence, prevalence and rate of amputation; rate of mortality, wound failure, dehiscence, time between index and ipsilateral reamputation; mobility, functional ability, activity and participation, quality of life, pain and psychosocial outcomes including depression and anxiety.
Prior to implementation, the data extraction spreadsheet will be piloted and refined. A number of articles covering the range of topics will be appraised by each of the reviewers and data extracted. Adaptations to the spreadsheet will be made in response to feedback on the pilot.
Data will be extracted by a primary reviewer and checked for accuracy and clarity by a second reviewer. Given the scope of the review, single data extraction with independent verification is preferred to duplicate data extraction given the significant time saving and that both approaches result in very similar error rates that have been shown to be inconsequential to the final outcome. Disagreements or inconsistencies in the data extraction or critical appraisal will be resolved through discussion until consensus. As necessary, a third reviewer will be called upon to also appraise the article and contribute to the consensus decision. Authors of the original research will be contacted for additional information or to clarify aspects of the method design as deemed necessary.
Risk of bias (quality) assessment
Included articles will be independently appraised by two reviewer using the McMaster Critical Review Forms. The McMaster Critical Review Forms are one of the few appraisal tools appropriate for use with a wide variety of study designs and include structured guidelines to reduce the likelihood of errors with use. The McMaster Critical Review Forms meet acceptable standards for content and initial construct validity as well as inter-rater and test re-test reliability. Results from the quality appraisal will be reported in tabular format using Microsoft Excel and include detailed comments to support the checklist items. Disagreements or inconsistencies in the critical appraisal will be resolved through discussion until consensus. As necessary, a third reviewer will be called upon to also appraise the article and contribute to the consensus decision.
Strategy for data synthesis
Findings from the review will be reported as a narrative without meta-analysis given the heterogeneity in terms of study design, outcome measures used and subjects will make meta-analysis inappropriate.
The results narratives will be presented by topic (e.g., mobility) and the literature characterized in terms of study designs, subject characteristics and outcome measures used. Studies will also be characterized in terms of their quality/risk of bias using the findings of the critical appraisal. Common issues with internal and external validity will be discussed with a specific focus on limitations that lead to imprecision, indirectness, inconsistency and publication bias. The extent to which these issues impact the results will be discussed and lead to an understanding about which studies engender the most confidence in the results and why.
Analysis of subgroups or subsets
Where possible, results will be reported with a breakdown by level of partial foot amputation and comparisons to the outcomes of people with transtibial amputation will be made.
Findings from the systematic review will be prepared for publication in a leading peer review journal and subsequently used in the development of shared decision making resources for people facing decisions about partial foot amputation.
Contact details for further information
Michael Dillon, PhD
Discipline of Prosthetics and Orthotics
School of Allied Health
College of Science, Health and Engineering
La Trobe University
Organisational affiliation of the review
La Trobe University
Dr Michael Dillon, La Trobe University Dr Stefania Fatone, Northwestern Mr Matthew Quigley, La Trobe University
Anticipated or actual start date
12 November 2015
Anticipated completion date
30 November 2016
The authors were funded to conduct this work by a grant from the American Orthotic Prosthetic Association (RFP-04012015) awarded to Drs. Michael Dillon and Stefania Fatone.
Conflicts of interest
Each of the investigators have previously published research that will be included in this systematic review. The authors declare that they have no financial competing interests.
Subject index terms status
Subject indexing assigned by CRD
Subject index terms
Amputation; Artificial Limbs; Decision Making; Health Resources; Humans
Any other information
The review is being undertaken to summarise outcomes of partial foot with a view to develop shared decision making resources.
Stage of review
Date of registration in PROSPERO
12 November 2015
Date of publication of this revision
26 November 2015
Stage of review at time of this submission
Piloting of the study selection process
Formal screening of search results against eligibility criteria
Risk of bias (quality) assessment
PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites.