Finola M Delamere1, Diane Horsley1, Helen Nankervis2, Jo Leonardi-Bee3
1Centre of Evidence-Based Dermatology, Cochrane Skin Group, The University of Nottingham, Nottingham, UK
2Centre of Evidence-Based Dermatology, Cochrane Skin Group, Nottingham University, Nottingham, UK
3Division of Epidemiology and Public Health, The University of Nottingham, Nottingham, UK
Citation example: Delamere FM, Horsley D, Nankervis H, Leonardi-Bee J. 'Template for title to be converted to protocol' [Protocol]. Cochrane Database of Systematic Reviews [Year], Issue [Issue].
Centre of Evidence-Based Dermatology
Cochrane Skin Group, The University of Nottingham
Room A103, King's Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
UK
E-mail: finola.delamere@nottingham.ac.uk
| Assessed as Up-to-date: | 19 March 2008 |
|---|---|
| Date of Search: | |
| Next Stage Expected: | 01 January 2009 |
| Protocol First Published: | Not specified |
| Review First Published: | Not specified |
| Last Citation Issue: | Not specified |
| Date / Event | Description |
|---|---|
| 19 March 2008 Amended | Changed to comply with RevMan 5 format |
| Date / Event | Description |
|---|---|
| 06 November 2007 New citation: major change | Substantive amendment |
Well-formulated review questions occur in the context of an already-formed body of knowledge. The background should address this context, help set the rationale for the review, and explain why the questions being asked are important. It should be concise (generally around one page when printed) and be understandable to the users of the intervention under investigation. All sources of information should be cited.
The review should begin with a brief description of the condition being addressed and its significance. It may include information about the biology, diagnosis, prognosis and public health importance (including prevalence or incidence).
A description of the experimental intervention(s) should place it in the context of any standard, or alternative interventions. The role of the comparator intervention(s) in standard practice should be made clear. For drugs, basic information on clinical pharmacology should be presented where available. This information might include dose range, metabolism, selective effects, half-life, duration and any known interactions with other drugs. For more complex interventions, a description of the main components should be provided.
This section might describe the theoretical reasoning why the interventions under review may have an impact on potential recipients, for example, by relating a drug intervention to the biology of the condition. Authors may refer to a body of empirical evidence such as similar interventions having an impact or identical interventions having an impact on other populations. Authors may also refer to a body of literature that justifies the possibility of effectiveness.
The background should clearly state the rationale for the review and should explain why the questions being asked are important. It might also mention why this review was undertaken and how it might relate to a wider review of a general problem. If this version of the review is an update of an earlier one, it is helpful to state this by writing, for example “This is an update of a Cochrane review first published in YEAR, and previously updated in YEAR”. This may be supplemented with a brief description of the main findings of the earlier versions, with a statement of any specific reasons there may be for updating the review.
This should begin with a precise statement of the primary objective of the review, ideally in a single sentence. Where possible the style should be of the form “To assess the effects of [intervention or comparison] for [health problem] for/in [types of people, disease or problem and setting if specified]”. This might be followed by a series of specific objectives relating to different participant groups, different comparisons of interventions or different outcome measures. It is not necessary to state specific hypotheses.
Eligible study designs should be stated here, along with any thresholds for inclusion based on the conduct of the studies or their risk of bias. For example, ‘All randomized controlled comparisons’ or ‘All randomized controlled trials with blind assessment of outcome’. Exclusion of particular types of randomized studies (for example, cross-over trials) should be justified.
The diseases or conditions of interest should be described here, including any restrictions such as diagnoses, age groups and settings. Subgroup analyses should not be listed here (see ‘Subgroup analysis and investigation of heterogeneity’ under ‘Methods’).
Experimental and comparator interventions should be defined here, under separate subheadings if appropriate. It should be made clear which comparisons are of interest. Restrictions on dose, frequency, intensity or duration should be stated. Subgroup analyses should not be listed here (see ‘Subgroup analysis and investigation of heterogeneity’ under ‘Methods’)
Note that outcome measures do not always form part of the criteria for including studies in a review. If they do not, then this should be made clear. Outcome measures of interest should be listed in this section whether or not they form part of the eligibility criteria.
The review’s primary outcomes should normally reflect at least one potential benefit and at least one potential area of harm, and should be as few as possible. It is normally expected that the review should be able to analyse these outcomes if eligible studies are identified, and that the conclusions of the review will be based in large part on the effects of the interventions on these outcomes.
Non-primary outcomes should be listed here. The total number of outcomes addressed should be kept as small as possible.
The following optional (level 4) headings may be helpful, as supplements or replacements for the headings above:
The timings for the outcomes should be stated, preferably using the following categories; short term, medium term and longer term. The primary timing should be highlighted.
In this section the electronic databases that are to be searched for the review should be listed. The Skin Group advises that as a minimum the following should be searched in this order:
Cochrane Skin Group Specialised Register,
The Cochrane Central Register of Controlled Trials in the Cochrane Library,
MEDLINE,
EMBASE
LILACs
Reports of ongoing trials can be found on several websites. The Skin Group recommends the following are searched for the review -so they need to be listed in the protocol:
www.controlled-trials.com,
www.clinicaltrials.gov,
www.anzctr.org.au,
www.who.int/trialsearch/
www.nottingham.ac.uk/ongoingskintrials.
Once the title of the review has been registered, the Trials Search Coordinator (TSC) Finola Delamere (Finola.Delamere@nottingham.ac.uk) will contact the lead author and offer assistance in the development of the search strategy section of the protocol. The Skin Group advises that a MEDLINE draft search strategy should be published in the protocol. The aim of this is to ensure that thought has been given to all the disease and intervention terms that may be relevant to finding trials for the review.
On publication of the protocol the TSC will discuss the development of all the strategies and then run the searches in each of the databases. She will ensure that all the strategies are included in the Revman review document.
Please contact Finola for any other queries regarding searching.
Unpublished trials are to be found from a number of sources. Trials may be reported at conferences (see below). PhD and MD theses (which are called 'Grey Literature' )may be a source of trials. List any sources that are to be searched for the review.
List any journals or conference abstracts you intend to search for the review. Please note the Skin Group does have a programme of systematic handsearching of journals and conference abstracts. To prevent duplication of effort, please check which journals/years/conference proceedings have been completed .
See http://www.mrw.interscience.wiley.com/cochrane/clabout/articles/SKIN/frame.html and scroll down to 'Specialised Register' .
Please search the bibliographies of included and excluded studies for any references to randomised controlled trials.
Please state which pharmaceutical companies etc you intend to contact when searching for reports of trials
The Cochrane Collaboration aims to include all sources of evidence, not just those in languages familiar to the reviewer. It is not necessary to get the whole paper translated; it is just the data that needs to be extracted. If you need help with deciding if a foreign language paper is an RCT and then with the subsequent data extraction, please contact the Skin Group editorial base. The Skin Group has a register of members who have offered help with translation and may be able to help you on an informal basis.
Please state in the protocol how this issue will be addressed. Depending upon the nature of the review it may be sufficient to record common adverse effects or it may be necessary to design a search strategy to look for rare but potentially serious side effects. However RCTs are unlikely to report serious, rare or long term adverse effects. For serious side effects a separate search for non-RCTs may need to be done and the information summarised qualitatively.
Please read Chapter 14 'Adverse Effects' of the Cochrane Handbook www.cochrane-handbook.org which gives advice on this issue.
The TSC will offer assistance, when the protocol is being written, so that the author considers the most practical approach to deal with this issue. Later when the protocol is published the TSC will help with running a search strategy to identify the adverse effects
This should describe the methods for data collection and analysis.
The method used to apply the selection criteria. Whether they are applied independently by more than one author should be stated, along with how any disagreements are resolved.
The method used to extract or obtain data from published reports or from the original researchers (for example, using a data collection form). Whether data are extracted independently by more than one author should be stated, along with how any disagreements are resolved. If relevant, methods for processing data in preparation for analysis should be described.
The method used to assess risk of bias (or methodological quality). Whether methods are applied independently by more than one author should be stated, along with how any disagreements are resolved. The tool(s) used should be described or referenced, with an indication of how the results are incorporated into the interpretation of the results.
The effect measures of choice should be stated. For example, odds ratio (OR), risk ratio (RR) or risk difference (RD) for dichotomous data; difference in means (MD) or standardized difference in means (SMD) for continuous data. For dichotomous outcomes, it is preferable to use the risk ratio as a measure of treatment effect if the primary outcomes in either treatment group is likely to commonly occur (>20%), this is because the odds ratio tends to give a biased result is this circumstance. The risk difference should not be used as the sole measure of treatment effect for the primary outcome measures since it only gives an absolute measure of effect (the difference in the risk of the event between the treatment groups) which depends on the underlying risk of events.
The following optional headings may be used, either in place of ‘Measures of treatment effect’ (in which case they would be level 3 headings) or as subheadings (level 4):
Special issues in the analysis of studies with non-standard designs, such as cross-over trials and cluster-randomized trials, should be described. Alternatively, optional (level 3) headings specific to the types of studies may be used, such as:
Strategies for dealing with missing data should be described. This will principally include missing participants due to drop-out (and whether an intention-to-treat analysis will be conducted), and missing statistics (such as standard deviations or correlation coefficients).
Approaches to addressing clinical heterogeneity should be described, along with how the authors will determine whether a meta-analysis is considered appropriate. Methods for identifying statistical heterogeneity should be stated (e.g. visually or using the I2 test).
This section should describe how publication bias and other reporting biases are addressed (for example, funnel plots, statistical tests, imputation). Authors should remember that asymmetric funnel plots are not necessarily caused by publication bias (and that publication bias does not necessarily cause asymmetry in a funnel plot).
The choice of meta-analysis method should be stated, including whether a fixed-effect or a random-effects model is used. Authors are advised to use a random effect model to account for moderate levels of statistical heterogeneity. If a fixed effect model is chosen then a statement of justification is needed. If meta-analyses are not undertaken, systematic approaches to synthesizing the findings of multiple studies should be described. If meta-analyses are not undertaken, systematic approaches to synthesizing the findings of multiple studies should be described.
All planned subgroup analyses should be listed (or independent variables for meta-regression). Any other methods for investigating heterogeneity of effects should be described.
This should describe analyses aimed at determining whether conclusions are robust to decisions made during the review process, such as inclusion/exclusion of particular studies from a meta-analysis, imputing missing data or choice of a method for analysis.
The following further headings for the Methods section may be helpful:
Authors seeking to cover economics aspects of interventions in a review will need to consider economics issues from the earliest stages of developing a protocol
This section should be used to acknowledge any people or organizations that the authors wish to acknowledge, including people who are not listed among the authors. This would include any previous authors of the Cochrane review or previous sources of support to the review, and might include the contributions of the editorial team of the CRG. Permission should be obtained from persons acknowledged
The contributions of the current co-authors to the protocol or review should be described in this section. One author should be identified as the guarantor of the review. All authors should discuss and agree on their respective descriptions of contribution before the review is submitted for publication on the CDSR. When the review is updated, this section should be checked and revised as necessary to ensure that it is accurate and up to date.
The following potential contributions have been adapted from Yank et al. (Yank 1999). This is a suggested scheme and the section should describe what people did, rather than attempt to identify which of these categories someone’s contribution falls within. Ideally, the authors should describe their contribution in their own words:
Authors should report any present or past affiliations or other involvement in any organization or entity with an interest in the review that might lead to a real or perceived conflict of interest. Situations that might be perceived by others as being capable of influencing a review author’s judgements include personal, political, academic and other possible conflicts, as well as financial conflicts. Authors must state if they have been involved in a study included in the review.
Financial conflicts of interest cause the most concern, and should be avoided, but must be reported if there are any. Any secondary interest (such as personal conflicts) that might unduly influence judgements made in a review (concerning, for example, the inclusion or exclusion of studies, assessments of the validity of included studies or the interpretation of results) should be reported.
If there are no known conflicts of interest, this should be stated explicitly, for example, by writing ‘None known’.