Subject: Nursing
Topic: What is the relationship between low birth weight and maternal primary hypertension OR What is the relationship between alcohol and acute psychosis
Paper details:
Unsure which topic would make a good paper and I entered two topics.. please just use one
Systematic reviews critical appraisal guide
Critical appraisal of systematic reviews also requires a slightly different approach to other critical appraisal tasks, again using the same evidence-based principals. More emphasis is placed on the methodology of the review, rather than the individual studies. If a meta-analysis is included, it is important to ensure that the studies have been appropriately combined.
Validity Where do I look?
Did the review explicitly address a focused clinical question? The main question being addressed should be clearly stated. The exposure, such as a therapy or diagnostic test, and the outcome(s) of interest will often be expressed in terms of a simple relationship but not necessarily a PICO question. | Introduction (title, abstract or final paragraph) | |
Was the search for relevant studies detailed and exhaustive? Ideally includes a comprehensive search for all relevant studies in the major bibliographic databases (e.g. Medline, Cochrane, EMBASE, etc) and a search of reference lists from relevant studies, contact with experts, and conference abstracts. The search strategy should be included so that the search can be repeated. The search should not be limited to English language only. The search strategy should include both MeSH terms and text words and should be reproducible. The results section will outline the number of titles and abstracts retrieved and reviewed and the number of full-text studies retrieved. | Methods Results | |
Was the selection of primary studies reproducible and free from bias? Ideally the authors should define transparent inclusion and exclusion criteria for the review. The selection of studies should be reproducible. The methods section should describe the inclusion and exclusion criteria for the review. The results section will outline the number of studies included/excluded together with the reasons for exclusion. This information may be presented in a figure or flow chart. | • • • | Results Figures Inclusion and exclusion criteria |
Was the quality of included studies assessed, and were they of a high standard? The article should describe how the quality of each study was assessed using predetermined quality criteria appropriate to the type of clinical question (e.g. randomization, blinding and completeness of follow-up). Results should be reproducible. The methods section should describe the assessment of quality and the criteria used (assessment of quality blinded to authors/title/journal is ideal). The results section should provide information on the quality of the individual studies which may be tabulated. | • • • | Methods Results Tables |
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Were all the important outcomes considered? Study outcomes should have been defined appropriately and should consider all clinically relevant outcomes. | • | Methods |
Are the individual studies adequately described? Important characteristics of individual studies should be described succinctly. The Results section should include a table or summary of important characteristics of included studies. This may be an Appendix in Cochrane Reviews, or available as supplementary data online for other papers. | • • • | Results Tables Appendix |
Were the results of primary studies combined appropriately? Any meta-analysis should combine the same outcome measures from individual studies. The results section should show which outcomes were combined. | • • • | Methods Statistics Results |
How are the results presented and is this appropriate to the data? A systematic review can include a meta-analysis if the data are appropriate to combine in this way. A meta-analysis combines the results of individual studies and produces a summary estimate of the intervention effect. This weights individual studies according to their size. Results are expressed in a standard way, such as relative risk, odds ratio, or mean difference between groups. Results are often displayed as a Forest plot, where individual studies are represented with a black square and horizontal line corresponding to the point effect of the study (where the square sits), the size of the study (size of the square), and the 95% confidence interval (black line). A diamond at the bottom represents the pooled effect of all trials and the combined 95% CI. If the diamond does not overlap ‘1’, we know that the pooled effect is statistically significant. Corresponding figures may include Odds Ratio or Hazard Ratio with 95% confidence intervals, weight (% of total) of the studies, and the number of events/patient number for individual studies. If the results are not suitable for meta-analysis, it is also valid to present them in a tabular form without statistical synthesis. | • • • • | Methods Statistics Figures Results |
Were the results similar from study to study? Ideally, the results of the different studies should be similar or homogeneous. If heterogeneity exists the authors may estimate whether the differences are significant (chi-square test). The results section should state whether the results are heterogeneous and discuss possible reasons for heterogeneity. The forest plot should show the results of the chisquare test for heterogeneity. | • • • | Methods Results Figures |
Has a sensitivity analysis been performed? A sensitivity analysis asks whether the results would change if the study inclusion criteria were changed. For example, what happens if we narrow the meta-analysis to include only adults? Or only high quality studies? It may or may not be appropriate to perform sensitivity analyses. | • • | Methods Results |
Clinical Importance Where do I look?
Are the outcomes clinically relevant? Check that the study outcome measures relate to the clinically important outcomes. | • | Methods |
How large was the treatment effect in meta-analysis? Have the results been presented in a way that you can understand them? | • • | Results Figures |
How precise was the estimate of treatment effect? A 95% confidence interval and p value give an estimate of the precision of the results. | Results Figures | |
Are the benefits worth the costs and potential toxicities? Have the authors also addressed toxicities and economic considerations in the review? Look for meta-analysis of toxicities, which may include only a subset of studies where this information was available from the original publication. | • | Results |
Is a Relative Risk, Absolute Risk Reduction or Number Needed to Treat (harm) given? If not, you can calculate them. More information about Relative Risk, Absolute Risk Reduction, and Number Need toTreat (harm). | Results Tables |
Applicability Where do I look?
Are the results discussed in relation to existing knowledge, and is the discussion biased? The discussion should place results into a clinical context and the authors conclusions should be justified by the study results. | • | Discussion |
How would I clearly express the results to a colleague or my patient? Try to extract data and describe the study findings to a patient or colleague in plain English. Use EBP calculations to help you do this. Put a NNT, ARR, NNH into a sentence for your patient. More information about Relative Risk, Absolute Risk Reduction, and Number Need toTreat (harm). | • • | Abstract Results |
Does this paper answer your clinical question or have you changed your question to suit the literature? Ask whether the paper helps you answer your clinical question. Ask yourself if your altered question is more or less relevant to your patient. Try another search or another paper if the meta-analysis answers questions that are not meaningful for your patient. | ||
How similar were the patients in the included trials to your patient or population? Check whether your patient would have been eligible for the clinical trials. Identify any important characteristics your patient has which have not been considered in the systematic review. Look for a sub-set analysis that has been done for a group more like your patient. | • • • | Methods Tables Figures |
Is treatment feasible and available in your clinical setting? Do you and your colleagues have the right skills to deliver this intervention? Consider whether the intervention or test is funded by insurers, Medicare, or the PBS. | • | Consider your practice setting |
University of Medicine and Science
RESEARCH PROTOCOL
Template for Systematic Reivew
Systematic reviews are widely considered to be the best source of research evidence. Systematic reviews, unlike literature reviews allow for a more objective appraisal of evidence. They can also highlight the lack of evidence and therefore identify areas where further research may be needed.
One definition of a systematic review is: ‘A review of a clearly formulated question that uses systematic methods to identify, select and critically appraise relevant research, and to collect and analyze data from the studies that are included in the review.’
STUDY TITLE:
The title of the review should be as descriptive as is reasonable and reflect the systematic review type.
If the review is examining clinical effectiveness this should be stated in the title. If specific interventions and/or patient outcomes are examined these should also be included in the title. Where possible the setting and target population should be stated.
INVESTIGATOR(S): names
RESEARCH QUESTION
You need to think about the population (the types of people), the type of intervention or exposures and the types of outcomes that are of interest.
Example
From the review ‘Interventions for basal cell carcinoma of the skin’.
Population: Adults of either gender who have one or more histologically proven, primary basal cell carcinoma (basal cell carcinoma is a type of skin cancer). It is important to include ‘histologically proven’ otherwise we may not know for sure if the lesions are basal cell carcinomas or something that could resembles basal cell carcinomas.
The intervention would be any treatment for basal cell carcinoma compared to ‘the gold standard’ or other types of treatment.
There should be one primary outcome which should reflect clinical practice and then a number of secondary outcomes. In general, reviews should include all reported outcomes that are likely to be meaningful to people making a decision about the healthcare problem the review addresses.
OBJECTIVES AND SPECIFIC AIM(S):
The review objectives must be stated in full. Conventionally a statement of the overall objective should be made and elements of the review then listed as review questions. This section should be as focused as possible and make explicit what the review intends to find out.
Example:
To conduct a systematic review to determine the best available evidence related to the post-harvest management of STSG donor sites.
The specific review questions to be addressed are:
What interventions/dressings used in the management of the STSG donor site is most effective: in reducing time to healing, in reducing rates of infection, and in reducing pain levels and promoting comfort?
What interventions/dressings are most effective in managing delayed healing/infection in the split skin graft donor site?
What interventions are most effective in managing the healed split skin donor site?
BACKGROUND
The background should describe the issue under review including the target population, interventions and outcomes that are documented in the literature. The background should be an overview of the main issues. It should provide sufficient detail to justify the conduct of the review and the choice of the various elements such as the interventions and outcomes. It is often as important to justify why elements are not included. In describing the background literature value statements about effect of interventions should be avoided.
Example:
“Use of acupuncture is effective in increasing smoking cessation rates in hospitalized patients”. This is what the review will determine. If this type of statement is made it should be clear that it is not the reviewer’s conclusion but that of a third party, such as “Smith indicates that acupuncture is effective in increasing smoking cessation rates in hospitalized patients”.
RESEARCH METHODS
Eligibility criteria: Criteria for Considering Studies for this Review
Specify the study characteristics and report characteristics that will be used as criteria for eligibility.
Types of studies
This section should flow from the background. Many reviews will have a hierarchy of studies that have been considered. There should be a statement about the target study type and the range of studies that were used if the primary study type was not found. Also, years considered, language, publication status. Need to give rationale.
Types of participants
There should be details about the type of individuals targeted including characteristics (e.g. age range), condition/diagnosis or health care issue (e.g. administration of medication in rural areas and the setting(s) in which these individuals are managed. Again the decisions about the types of participants should have been justified in the background.
Types of interventions ((if applicable)
There should be a list of all the interventions examined. In some cases it may be appropriate to list categories of interventions. For example: “pharmaceutical and non- pharmaceutical interventions for smoking cessation”. This section should be concise as the background section provides an opportunity to describe the main aspects of the interventions.
Types of outcome measures
There should be a list of the outcome measures considered. The clinical relevance of the outcomes must be considered. The background should provide enough information to justify the outcomes included.
Search Strategy and Information Sources
An overview of the search strategy should be provided. It is usual to undertake a staged approach including initial search, full search and search of reference lists and hand searching. The databases searched should be listed with the time frames included. The initial search terms should be appropriate for the review objectives. If reference lists, grey literature and selective hand searching are used this should be stated. A statement about assessment should be included.
Example:
“All studies identified during the database search were assessed for relevance to the review based on the information provided in the title, abstract, and descriptor/MeSH terms. A full report was retrieved for all studies that met the inclusion criteria (see appendix I). Studies identified from reference list searches were assessed for relevance based on the study title.”
You need to generate lists of citations from relevant resources. Some databases you can use to search include:
The citations identified need to be screened for relevance to the review question. Full manuscripts need to be obtained for potentially all relevant studies. Then, go through the papers to decide on whether to include these in the review or exclude them. This will be done based on the explicit study selection criteria.
Methods of the Review (data collection process):
Assessment of methodological quality
A description of how methodological assessment was managed should include reference to the checklist developed by the review team.
Assessing the quality of the included studies is an important step. Quality refers to the internal validity. The internal validity of a study refers to the degree which its results are likely to be free from bias.
Bias: is any process at any stage of inference tending to produce results that differ systematically from the true values.
There are four main sources of systematic bias in trials of the effects of healthcare:
Data extraction
A description of how data extraction will be managed should include reference to the data extraction tool developed by the review team. In some cases revision of the data extraction tool will occur after the full search has been conducted. A statement should be made to that effect.
Data synthesis
A description of how data synthesis will be managed should be included. Describe the methods of handling data and combining results of the studies.
REVIEW RESULTS
Description of the selected studies
The type and number of papers identified and the number of papers that will be included and excluded should be stated. Reasons for exclusion at each stage should be presented using the flow diagram.
For each study, present characteristics for which data were extracted [e.g., study size, study variables, follow-up period, .. ] and provide citations.
Methodological quality
This should be a summary of the overall quality of the literature identified. Present data on the risk of bias of each study.
Results of individual studies:
This section must be organized in a meaningful way based on the objectives of the review and the criteria for considering studies particularly considering types of interventions and outcomes.
For all outcomes considered, present for each study, simple summary data for the intervention and comparison groups and the effect estimate.
Present results of any assessment of risk of bias across studies.
DISCUSSION
The discussion should include an overview of the results and summary of the main findings including the strength of evidence for each main outcome taking into consideration their relevance to the groups [e.g., users, health care providers].
Limitations
It should address issues arising from the conduct of the review including limitations [discuss limitations at study and outcome level and at review level] and issues arising from the results of the review.
Conclusions
Provide a general interpretation of the results in the context of other evidence.
Implications for practice
Where possible implications for practice should be detailed, but must be based on the documented results, not author opinion. Where evidence is of a sufficient level, appropriate recommendations should be made. Recommendations must be clear, concise and unambiguous.
Implications for research
All implications for research must be derived from the results of the review.
REFERENCES: (USE ENDNOTE)