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National Center for Complementary & Alternative Medicine
This guide provides resources that point to new directions in complementary and alternative medicine (CAM) research. Over the years, researchers have identified the strengths and weaknesses of existing methodologies, and are now exploring new initiatives to advance CAM's clinical evidence base.
Clinical research is the “proof of principle” that a basic discovery has the potential to advance medicine and improve health. Clinical research scientists are the translators. Their role is to recognize the clinical relevance of basic discoveries and design the optimal means for determining if the discovery leads to improved health. In doing so, they can bridge a gap between knowledge produced at the lab bench and its use at the clinical bedside. Optimal translation demands the thoughtful, statistically sound analysis of data derived from a meticulously designed and conducted clinical research study. (Description adapted from Stanford Medicine Clinical Research Program Overview)
What is a systematic review?
A systematic review summarises the results of available carefully designed healthcare studies (controlled trials) and provides a high level of evidence on the effectiveness of healthcare interventions. (Cochrane Handbook for Systematic Reviews of Interventions, 2011)
Estimated timeline for completing a Cochrane systematic review:
|
Month |
Activity |
|
1-2 |
Preparation of protocol |
|
3-8 |
Searches for published and unpublished studies |
|
2-3 |
Pilot test of eligibility criteria |
|
3-8 |
Inclusion assessments |
|
3 |
Pilot test of Risk of Bias assessment |
|
3-10 |
Validity assessments |
|
3 |
Pilot test of data collection |
|
3-10 |
Data collection |
|
3-10 |
Data entry |
|
5-11 |
Follow-up of missing information |
|
8-10 |
Analysis |
|
1-11 |
Preparation of review report |
|
12- |
Keeping the review up-to-date |
|
Source: |
Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org. Courtesy of the University of Maryland HS/HSL |
If you are considering a systematic review project, we suggest you consult the following documents; they provide the framework for conducting systematic reviews.
Additionally, researchers should use the PRISMA statement (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) when writing the reivew. The PRISMA statement consists of a 27-item checklist and a four phase flow diagram. PRISMA is an evidence-based minimum set of items for reporting in systematic reviews and meta-analyses.
IRB Web Resources
The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.
Journal Articles
More resources:
Understanding Patients' Needs & Experiences (from Public Library of Science (PLoS))
Qualitative vs. quantitative research (from Xavier University Library).
Grey literature (GL) is defined as:
"Materials not published commercially or indexed by major databases.
"Ephemeral," "invisible" literature that may be unpublished, unevaluated, not peer-reviewed.
"Information produced on all levels of government, academics, business and industry in electronic and print formats not controlled by commercial publishing i.e. where publishing is not the primary activity of the producing body." (Luxembourg, 1997 - Expanded in New York, 2004) (http://www.greynet.org/)
Resources for locating grey literature:
Government Resources