Evidence level and quality rating: \tGood quality, level III evidence<\/p>\n
Article title: Outer retina dysfunction and choriocapillaries impairment in type 1 diabetes
\nNumber: (2021)11:15183<\/p>\n
Author(s): M. Parravano, L. Ziccardi, E. Borrelli, E. Costanzo, S. Frontoni, F. Picconi, V. Parisi, R. Saccoini, Di Renzo, M. Varano and G. Querques
\nPublication date: 2021, July26<\/p>\n
Journal: Scientific reports<\/p>\n
Setting: Department of opthamology, IRCCS-Fondazi-one Bietti, Rome
\nSample: 43<\/p>\n
Does this evidence address my EBP question? \uf0a2Yes
\n\u2610No-Do not proceed with appraisal of this evidence<\/p>\n
Is this study:
\n\u2610QuaNtitative (collection, analysis, and reporting of numerical data)
\nMeasurable data (how many; how much; or how often) used to formulate facts, uncover patterns in research, and generalize results from a larger sample population; provides observed effects of a program, problem, or condition, measured precisely, rather than through researcher interpretation of data. Common methods are surveys, face-to-face structured interviews, observations, and reviews of records or documents. Statistical tests are used in data analysis.
\nGo to Section I: QuaNtitative
\n\u2610QuaLitative (collection, analysis, and reporting of narrative data)
\nRich narrative documents are used for uncovering themes; describes a problem or condition from the point of view of those experiencing it. Common methods are focus groups, individual interviews (unstructured or semi structured), and participation\/observations. Sample sizes are small and are determined when data saturation is achieved. Data saturation is reached when the researcher identifies that no new themes emerge and redundancy is occurring. Synthesis is used in data analysis. Often a starting point for studies when little research exists; may use results to design empirical studies. The researcher describes, analyzes, and interprets reports, descriptions, and observations from participants.
\nGo to Section II: QuaLitative
\n\u2610Mixed methods (results reported both numerically and narratively)
\nBoth quaNtitative and quaLitative methods are used in the study design. Using both approaches, in combination, provides a better understanding of research problems than using either approach alone. Sample sizes vary based on methods used. Data collection involves collecting and analyzing both quaNtitative and quaLitative data in a single study or series of studies. Interpretation is continual and can influence stages in the research process.
\nGo to Section III: Mixed Methods<\/p>\n
Section I: QuaNtitative
\nLevel of Evidence (Study Design)
\nIs this a report of a single research study?
\n\u2610 Yes
\n\u2610 No
\nGo to B
\n1. Was there manipulation of an independent variable?\t \u2610 Yes
\n\u2610 No<\/p>\n
2. Was there a control group?\t \u2610 Yes
\n\u2610 No<\/p>\n
3. Were study participants randomly assigned to the intervention and control groups?\t \u2610 Yes
\n\u2610 No<\/p>\n
If Yes to questions 1, 2, and 3, this is a randomized controlled trial (RCT) or experimental study.\tLEVEL I
\nIf Yes to questions 1 and 2 and No to question 3 or Yes to question 1 and No to questions 2 and 3, this is quasi-experimental.
\n(Some degree of investigator control, some manipulation of an independent variable, lacks random assignment to groups, and may have a control group).\tLEVEL II
\nIf No to questions 1, 2, and 3, this is nonexperimental.
\n(No manipulation of independent variable; can be descriptive, comparative, or correlational; often uses secondary data).\tLEVEL III
\nStudy Findings That Help Answer the EBP Question:
\nEnter Text Here<\/p>\n
Skip to the Appraisal of QuaNtitative Research Studies section<\/p>\n
Section I: QuaNtitative (continued)
\nIs this a summary of multiple sources of research evidence?\t \u2610Yes
\nContinue\t \u2610No
\nUse Appendix F
\n1. Does it employ a comprehensive search strategy and rigorous appraisal method?
\nIf this study includes research, nonresearch, and experiential evidence, it is an integrative review (see Appendix F).\t \u2610Yes
\nContinue\t \u2610No
\nUse Appendix F
\n2. For systematic reviews and systematic reviews with meta-analysis
\n(see descriptions below):
\na.\tAre all studies included RCTs?\t \u2610LEVEL I<\/p>\n
b.\tAre the studies a combination of RCTs and quasi-experimental, or quasi-experimental only?\t \u2610LEVEL II<\/p>\n
c.\tAre the studies a combination of RCTs, quasi-experimental, and nonexperimental, or non- experimental only?\t \u2610LEVEL III<\/p>\n
A systematic review employs a search strategy and a rigorous appraisal method, but does not generate an effect size.
\nA meta-analysis, or systematic review with meta-analysis, combines and analyzes results from studies to generate a new statistic: the effect size.
\nStudy Findings That Help Answer the EBP Question:
\nEnter Text Here<\/p>\n
Skip to the Appraisal of Systematic Review (With or Without a Meta-Analysis) section<\/p>\n
Appraisal of QuaNtitative Research Studies
\nDoes the researcher identify what is known and not known about the problem and how the study will address any gaps in knowledge?\t \u2610 Yes
\n\u2610 No<\/p>\n
Was the purpose of the study clearly presented?\t\u2610 Yes
\n\u2610 No<\/p>\n
Was the literature review current (most sources within the past five years or a seminal study)?\t \u2610 Yes
\n\u2610 No<\/p>\n
Was sample size sufficient based on study design and rationale?\t \u2610 Yes
\n\u2610 No<\/p>\n
If there is a control group:
\n\u2022\tWere the characteristics and\/or demographics similar in both the control and intervention groups?\t \u2610 Yes
\n\u2610 No<\/p>\n
\u2610N\/A<\/p>\n
\u2022\tIf multiple settings were used, were the settings similar?\t \u2610 Yes
\n\u2610 No
\n\u2610N\/A<\/p>\n
\u2022\tWere all groups equally treated except for the intervention group(s)?\t \u2610 Yes
\n\u2610 No
\n\u2610N\/A<\/p>\n
Are data collection methods described clearly?\t\u2610 Yes
\n\u2610 No<\/p>\n
Were the instruments reliable (Cronbach\u2019s \uf061[alpha] > 0.70)?\t\u2610 Yes
\n\u2610 No
\n\u2610N\/A<\/p>\n
Was instrument validity discussed?\t\u2610 Yes
\n\u2610 No
\n\u2610N\/A<\/p>\n
If surveys or questionnaires were used, was the response
\nrate > 25%?\t\u2610 Yes
\n\u2610 No
\n\u2610N\/A<\/p>\n
Were the results presented clearly?\t\u2610 Yes
\n\u2610 No<\/p>\n
If tables were presented, was the narrative consistent with the table content?\t\u2610 Yes
\n\u2610 No
\n\u2610N\/A<\/p>\n
Were study limitations identified and addressed?\t\u2610 Yes
\n\u2610 No<\/p>\n
Were conclusions based on results?\t\u2610 Yes
\n\u2610 No<\/p>\n
Complete the Quality Rating for QuaNtitative Studies section<\/p>\n
Appraisal of Systematic Review (With or Without Meta-Analysis)
\nWere the variables of interest clearly identified?\t\u2610 Yes
\n\u2610 No<\/p>\n
Was the search comprehensive and reproducible?
\n\u2022\tKey search terms stated\t\u2610 Yes
\n\u2610 No<\/p>\n
\u2022\tMultiple databases searched and identified\t\u2610 Yes
\n\u2610 No<\/p>\n
\u2022\tInclusion and exclusion criteria stated\t\u2610 Yes
\n\u2610 No<\/p>\n
Was there a flow diagram that included the number of studies eliminated at each level of review?\t\u2610 Yes
\n\u2610 No<\/p>\n
Were details of included studies presented (design, sample, methods, results, outcomes, strengths, and limitations)?\t\u2610 Yes
\n\u2610 No<\/p>\n
Were methods for appraising the strength of evidence (level and quality) described?\t\u2610 Yes
\n\u2610 No<\/p>\n
Were conclusions based on results?\t\u2610 Yes
\n\u2610 No<\/p>\n
\u2022\tResults were interpreted\t\u2610 Yes
\n\u2610 No<\/p>\n
\u2022\tConclusions flowed logically from the interpretation and systematic review question\t\u2610 Yes
\n\u2610 No<\/p>\n
Did the systematic review include a section addressing limitations and how they were addressed?\t\u2610 Yes
\n\u2610 No<\/p>\n
Complete the Quality Rating for QuaNtitative Studies section (below)
\nQuality Rating for QuaNtitative Studies
\nCircle the appropriate quality rating below:
\nA High quality: Consistent, generalizable results; sufficient sample size for the study design; adequate control; definitive conclusions; consistent recommendations based on comprehensive literature review that includes thorough reference to scientific evidence.
\nB Good quality: Reasonably consistent results; sufficient sample size for the study design; some control, and fairly definitive conclusions; reasonably consistent recommendations based on fairly comprehensive literature review that includes some reference to scientific evidence.
\nC Low quality or major flaws: Little evidence with inconsistent results; insufficient sample size for the study design; conclusions cannot be drawn.<\/p>\n
Section II: QuaLitative
\nLevel of Evidence (Study Design)<\/p>\n
Is this a report of a single research study?
\n\uf0a2 Yes
\nthis is Level III
\n\u2610 No
\ngo to II B
\nStudy Findings That Help Answer the EBP Question:
\nPatients with diabetes experienced significant maladaptations in the retina and choroid when afflicted by diabetic retinopathy. The features which are noted at the onset of the condition that is characterized by impaired eye function becomes more severe as the condition aggravates.<\/p>\n
Complete the Appraisal of Single QuaLitative Research Study section (below)<\/p>\n
Appraisal of a Single QuaLitative Research Study
\nWas there a clearly identifiable and articulated:
\n\u2022\tPurpose?\t\uf0a2 Yes
\n\u2610 No<\/p>\n
\u2022\tResearch question?\t\uf0a2 Yes
\n\u2610 No<\/p>\n
\u2022\tJustification for method(s) used?\t\uf0a2 Yes
\n\u2610 No<\/p>\n
\u2022\tPhenomenon that is the focus of the research?\t\uf0a2 Yes
\n\u2610 No<\/p>\n
Were study sample participants representative?\t\uf0a2 Yes
\n\u2610 No<\/p>\n
Did they have knowledge of or experience with the research area?\t\uf0a2 Yes
\n\u2610 No<\/p>\n
Were participant characteristics described?\t\uf0a2 Yes
\n\u2610 No<\/p>\n
Was sampling adequate, as evidenced by achieving saturation of data?\t\u2610 Yes
\n\uf0a2 No<\/p>\n
Data analysis:
\n\u2022\tWas a verification process used in every step by checking and confirming with participants the trustworthiness of analysis and interpretation?\t\u2610 Yes
\n\uf0a2 No<\/p>\n
\u2022\tWas there a description of how data were analyzed (i.e., method), by computer or manually?\t\uf0a2 Yes
\n\u2610 No<\/p>\n
Do findings support the narrative data (quotes)?\t\uf0a2 Yes
\n\u2610 No<\/p>\n
Do findings flow from research question to data collected to analysis undertaken?\t\uf0a2 Yes
\n\u2610 No<\/p>\n
Are conclusions clearly explained?\t\u2610 Yes
\n\u2610 No<\/p>\n
Skip to the Quality Rating for QuaLitative Studies section<\/p>\n
For summaries of multiple quaLitative research studies (meta-synthesis), was a comprehensive search strategy and rigorous appraisal method used?\t\u2610 Yes
\nLevel III\t\u2610 No
\ngo to Appendix F
\nStudy Findings That Help Answer the EBP Question:
\nEnter Text Here<\/p>\n
Complete the Appraisal of Meta-Synthesis Studies section (below)<\/p>\n
Appraisal of Meta-Synthesis Studies
\nWere the search strategy and criteria for selecting primary studies clearly defined?\t\u2610 Yes
\n\u2610 No<\/p>\n
Were findings appropriate and convincing?\t\u2610 Yes
\n\u2610 No<\/p>\n
Was a description of methods used to:
\n\u2022\tCompare findings from each study?\t\u2610 Yes
\n\u2610 No<\/p>\n
\u2022\tInterpret data?\t\u2610 Yes
\n\u2610 No<\/p>\n
Did synthesis reflect:\t\u2610 Yes
\n\u2610 No<\/p>\n
\u2022\tNew insights?\t\u2610 Yes
\n\u2610 No<\/p>\n
\u2022\tDiscovery of essential features of phenomena?\t\u2610 Yes
\n\u2610 No<\/p>\n
\u2022\tA fuller understanding of the phenomena?\t\u2610 Yes
\n\u2610 No<\/p>\n
Was sufficient data presented to support the interpretations?\t\u2610 Yes
\n\u2610 No<\/p>\n
Complete the Quality Rating for QuaLititative Studies section (below)<\/p>\n
Quality Rating for QuaLitative Studies
\nSelect the appropriate quality rating below:
\nNo commonly agreed-on principles exist for judging the quality of quaLitative studies. It is a subjective process based on the extent to which study data contributes to synthesis and how much information is known about the researchers\u2019 efforts to meet the appraisal criteria.
\nFor meta-synthesis, there is preliminary agreement that quality assessments should be made before synthesis to screen out poor-quality studies1.
\n\uf0a2A\/B High\/Good quality is used for single studies and meta-syntheses2.
\nThe report discusses efforts to enhance or evaluate the quality of the data and the overall inquiry in sufficient detail; and it describes the specific techniques used to enhance the quality of the inquiry.
\nEvidence of some or all of the following is found in the report:
\n\u2022\tTransparency: Describes how information was documented to justify decisions, how data were reviewed by others, and how themes and categories were formulated.
\n\u2022\tDiligence: Reads and rereads data to check interpretations; seeks opportunity to find multiple sources to corroborate evidence.
\n\u2022\tVerification: The process of checking, confirming, and ensuring methodologic coherence.
\n\u2022\tSelf-reflection and self-scrutiny: Being continuously aware of how a researcher\u2019s experiences, background, or prejudices might shape and bias analysis and interpretations.
\n\u2022\tParticipant-driven inquiry: Participants shape the scope and breadth of questions; analysis and interpretation give voice to those who participated.
\n\u2022\tInsightful interpretation: Data and knowledge are linked in meaningful ways to relevant literature.
\n\u2610C Lower-quality studies contribute little to the overall review of findings and have few, if any, of the features listed for High\/Good quality.<\/p>\n
1 https:\/\/www.york.ac.uk\/crd\/SysRev\/!SSL!\/WebHelp\/6_4_ASSESSMENT_OF_QUALITATIVE_RESEARCH.htm
\n2 Adapted from Polit & Beck (2017).<\/p>\n
Section III: Mixed Methods
\nLevel of Evidence (Study Design)
\nYou will need to appraise both the quaNtitative and quaLitative parts of the study independently, before appraising the study in its entirety.
\n1.\tEvaluate the quaNitative part of the study using Section I. \tLevel\tQuality
\nInsert here the level of evidence and overall quality for this part:\tLevel
\nQuality<\/p>\n
2.\tEvaluate the quaLitative part of the study using Section II. \tLevel\tQuality
\nInsert here the level of evidence and overall quality for this part:\tLevel
\nQuality<\/p>\n
3.\tTo determine the level of evidence, circle the appropriate study design:
\n\u2022\tExplanatory sequential designs collect quaNtitative data first, followed by the quaLitative data; and their purpose is to explain quaNtitative results using quaLitative findings. The level is determined based on the level of the quaNtitative part.
\n\u2022\tExploratory sequential designs collect quaLitative data first, followed by the quaNtitative data; and their purpose is to explain quaLitative findings using the quaNtitative results. The level is determined based on the level of the quaLitative part, and it is always Level III.
\n\u2022\tConvergent parallel designs collect the quaLitative and quaNtitative data concurrently for the purpose of providing a more complete understanding of a phenomenon by merging both datasets. These designs are Level III.
\n\u2022\tMultiphasic designs collect quaLitative and quaNtitative data over more than one phase, with each phase informing the next phase. These designs are Level III.
\nStudy Findings That Help Answer the EBP Question:
\nEnter Text Here<\/p>\n
Complete the Appraisal of Mixed Methods Studies section (below)<\/p>\n
Appraisal of Mixed Methods Studies3
\nWas the mixed-methods research design relevant to address the quaNtitative and quaLitative research questions (or objectives)?\t\u2610 Yes
\n\u2610 No
\n\u2610N\/A<\/p>\n
Was the research design relevant to address the quaNtitative and quaLitative aspects of the mixed-methods question (or objective)?\t\u2610 Yes
\n\u2610 No
\n\u2610N\/A<\/p>\n
For convergent parallel designs, was the integration of quaNtitative and quaLitative data (or results) relevant to address the research question or objective?\t\u2610 Yes
\n\u2610 No
\n\u2610N\/A<\/p>\n
For convergent parallel designs, were the limitations associated with the integration (for example, the divergence of quaLitative and quaNtitative data or results) sufficiently addressed?\t\u2610 Yes
\n\u2610 No
\n\u2610N\/A<\/p>\n
Complete the Quality Rating for Mixed-Method Studies section (below)<\/p>\n
3 National Collaborating Centre for Methods and Tools. (2015). Appraising Qualitative, Quantitative, and Mixed Methods Studies included in Mixed Studies Reviews: The MMAT. Hamilton, ON: McMaster University. (Updated 20 July, 2015) Retrieved from http:\/\/www.nccmt.ca\/ resources\/search\/232<\/p>\n
Quality Rating for Mixed-Methods Studies
\nCircle the appropriate quality rating below
\nA High quality: Contains high-quality quaNtitative and quaLitative study components; highly relevant study design; relevant integration of data or results; and careful consideration of the limitations of the chosen approach.
\nB Good quality: Contains good-quality quaNtitative and quaLitative study components; relevant study design; moderately relevant integration of data or results; and some discussion of limitations of integration.
\nC Low quality or major flaws: Contains low quality quaNtitative and quaLitative study components; study design not relevant to research questions or objectives; poorly integrated data or results; and no consideration of limits of integration.<\/p>\n","protected":false},"excerpt":{"rendered":"
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