 |
| Editorial Information |
| The articles in Core Evidence
are prepared using the principles of evidence-based medicine
and critical appraisal. |
|
| Format and content |
| The format and content of the articles
are derived from formulary guideline requirements that focus
on relevant outcomes. |
|
| Drug selection |
| Drugs considered for inclusion in
Core Evidence are chosen on the basis of their potential
impact on patient outcomes, disease management, and healthcare
priorities. The Editor-in-Chief selects the drugs for review
based on the following criteria: |
| Therapeutic area |
 |
1º care indication |
|
2º care/specialist indication, 1º/2º
care interface |
|
Chronic condition |
| Outcomes clear and objective |
|
Outcomes clear and objective |
|
Disease-oriented |
| Added therapeutic value |
|
Significant health benefit |
| |
increase life expectancy/QOL |
| |
decrease disability/adverse effects |
|
Significant impact on resources |
|
Transform treatment of a disease (current guidelines
significantly affected) |
|
Clear areas of unmet medical need (patient groups,
single aspects of disease, symptoms, side effects of existing
treatment) |
| Sufficient evidence base |
| Timeliness |
| Drug |
|
New/novel mechanism of action/first in class |
|
New indication existing drug |
|
Analyst sales expectations high |
|
|
| Evidence review |
| The editorial process is a rigorous,
objective, and transparent method for evidence retrieval, selection,
appraisal, and synthesis. |
|
| Retrieval and selection |
| The English language literature
is searched using terms specific to the scope of the article.
The following sources are routinely searched: York University
Centre for Reviews and Dissemination (CRD) databases; Cochrane
Database of Systematic Reviews; Clinical Evidence; PubMed/Medline;
EMBASE; BIOSIS; and National Guideline Clearing House.
To limit potential publication bias, publicly accessible clinical
trial registers are also searched. Evidence is selected according
to the scope of the article. |
|
| Appraisal |
| The validity and quality of the
evidence is evaluated using a hierarchy of evidence and critical
appraisal. |
| Level |
| 1. |
Strong evidence from at least one systematic
review |
| 2. |
Evidence from randomized controlled trials |
| 3. |
Evidence from well-designed trials without randomization,
single group pre-/postintervention, cohort, time series,
or matched case control studies |
| 4. |
Evidence from well-designed nonexperimental, observational
studies from more than one center or research group |
| 5. |
Opinions of respected authorities, based on clinical
experience, descriptive studies, and reports of expert
committees |
| Adapted from Clark W, Mucklow J. Gathering
and weighing the evidence. In: Panton R, Chapman S (editors).
Medicines Management. London: BMJ Books and Pharmaceutical
Press; 1998. |
|
| Randomized controlled trials and
economic studies are appraised to assess their strengths, weaknesses,
and validity. Outcomes are selected based on clinical relevance
and perceived unmet medical need. |
|
| Synthesis |
| The weight, strength, and consistency
of the evidence for a drug’s effectiveness on each outcome
are evaluated to give a definitive implication for clinical
practice wherever possible. Conclusions are based on the level
of evidence, its quality, and its consistency. Outcome measures
are defined as patient-oriented, disease-oriented, or economic. |
|
| The evidence is summarized as clear,
substantial, moderate, limited, or absent depending on a combination
of evidence level, its strengths and weaknesses, and its consistency. |
|
| Conflict of interest |
| Core Evidence complies
with the guidelines issued by the International Committee
of Medical Journal Editors (ICMJE) regarding conflict of interest.
|
|
|
| Editorial staff |
| The editorial staff, Consultant
Editor, and Editorial Board of Core Evidence, are required
to disclose any financial or personal relationship that could
be viewed as a potential conflict of interest that may inappropriately
influence editorial decisions. This information is gathered
annually. The policy of recusal operates. Whenever an individual
has a potential conflict of interest, he/she must advise the
Editor-in-Chief of the nature of the conflict and offer to recuse
him/herself from making decisions on the journal. |
|
| The Editor-in-Chief will evaluate
each case and either accept or reject the offer of recusal,
based on the following guidelines. If a potential conflict is
identified but is not judged of sufficient significance to warrant
recusal, it will be acknowledged in an appropriate place (e.g.
on the core website). |
|
| Authors |
| Articles published in Core
Evidence are prepared by professional writers who are contracted
to write either as employees of Core Medical Publishing or as
freelance writers. Writers are also required to disclose any
financial or personal relationship that could be viewed as a
potential conflict of interest that may inappropriately influence
editorial decisions. The same policy of recusal as applies to
other editorial staff applies. |
|
| Peer reviewers |
| Individuals invited to act
as peer reviewers of Core Evidence articles are also
required to disclose any financial or personal relationship
that could be viewed as a potential conflict of interest that
may inappropriately influence editorial decisions. The same
policy of recusal as applies to other editorial staff applies.
If a potential conflict is identified but is not judged of
sufficient significance to warrant recusal, it will be acknowledged
at the end of the article. |
| |
Editor |
Author |
Editorial board |
Peer reviewer |
| Employment |
Recuse |
Recuse |
Recuse |
Recuse |
Non executive director/
management
position |
Recuse |
Recuse |
Acknowledge |
Acknowledge |
Consultancy,
opinion leader, speaker |
Recuse |
Acknowledge |
Acknowledge |
Acknowledge |
| Investigator |
Acknowledge |
Acknowledge |
Acknowledge |
Acknowledge |
| Shareholder |
Acknowledge |
Acknowledge |
Acknowledge |
Acknowledge |
|
| Manufacturer review |
| Manufacturers of drugs which are
the subject of Core Evidence reviews are invited to comment
on the factual accuracy and completeness of the article. This
step occurs in parallel with peer review. |
|
| Editorial approval |
| The Editor-in-Chief has final
responsibility for the content of Core Evidence, and
will decide which articles are acceptable for publication,
taking into account the recommendations made during the review
process. The Consultant Editor also judges the balance, consistency,
and clinical content of each article before giving approval
to publish.
|
