Research 101 Workshop

Transcription

1 Research 101 Workshop In an Hour We Will Cover EYE BANK ASSOCIATION OF AMERICA ANNUAL MEETING, HOLLYWOOD, FL JUNE 21, 2012 DR. JENNIFER LI, JACKIE MALLING, CHRIS STOEGER, MICHAEL TITUS Research Process Overview Helpful Hints to Get Started We Do Research Already Group Exercise Idea Discussion Resources Scientific Method Research Process Scientific Method 1. Ask a Question 2. Search (previous studies, background info) 3. Create Hypothesis (description of observation) and make predictions 4. Test (do an experiment) 5. Analyze Results / Draw Conclusions 6. Hypothesis T or F 7. Report / Publish / Ask a Question! 1

2 Helpful Hints to Get Started MICHAEL TITUS Doing the Prep Work Discuss with Others Helps define the goals and scope Surgeons Clinical Directors Eye Bank Staff Acknowledgements Recognize your colleagues contributions Doing the Prep Work Write out Goals and Procedures Clarify each step Keep the project organized Review with coauthors for additions Working on Your Project Dedication Recognize the commitment required The process goes smoother when you are dedicated to its completion Allow enough time to do it well 2

3 Working on Your Project Persistence and Patience New procedures can take time to learn Errors can occur Take time to figure them out Work with you group to identify causes and solutions A result that does not show your hypothesis to be true is still a result Working on Your Project Continue to Review Helps to keep you on the right path Can reveal variables previously unaccounted for Ensures the data collected is best organized for your project Data Collection Data Collection Define the Method Paper notes Database Good for organization and analysis Can easily be shared Excel Access Filemaker Pro Keep it Organized Break larger projects into groups Take good notes of observations Keep hardcopies of notes and raw data 3

4 Data Collection Keys to Success Stay Consistent Helps achieve reliable and valid results Reduces errors Use reproducible methods Use the same people for data collection Good Planning Goes a Long Way Build a dynamic team Stay organized throughout Have Fun! We Do Research Already Disclaimer CHRIS STOEGER The examples we chose are in no way an exhaustive review of eye bank related research We wish to give you some clear ideas of research that can be done, at least in part, by eye bankers 4

5 Cornea Preservation Time Study Cornea Donor Study (CDS) CPTS Asks the question does the death to surgery interval matter clinically? If you are a study site, you are doing research This is data collection at its finest What can we expect for publications from this study? CPTS is modeled on the same study design as CDS CDS asked the question does the donor age matter clinically? To date, the CDS study site lists 15 publications from this one study Ancillary questions were able to be answered due to the robust data set Cornea Donor Study Publications Cornea Donor Study 1. Lass JH, Beck RW, Benetz BA, Dontchev M, Gal RL, Holland EJ, Kollman C, Mannis MJ, Price F, Raber I, Stark WJ, Stulting RD, Sugar A for the Cornea Donor Study Investigator Group. Baseline factors related to endothelial cell loss following penetrating keratoplasty. Archives of Ophthalmology 2011; 129: Lass JH, Sugar A, Benetz BA, Beck RW, Dontchev M, Gal RL, Kollman C, Gross R, Heck E, Holland EJ, Mannis MJ, Raber I, Stark WJ, Stulting RD for the Cornea Donor Study Investigator Group. Endothelial cell density to predict endothelial graft failure after penetrating keratoplasty. Archives of Ophthalmology 2010; 128: (Published). 3. Sugar J, Montoya M, Dontchev M, Tanner JP, Beck RW, Gal RL, Gallagher S, Gaster R, Heck E, Holland EJ, Kollman C, Malling J, Mannis MJ, Woody J for the Cornea Donor Study Investigator Group. Donor risk factors for graft failure in the Cornea Donor Study. Cornea 2009; 28: (Published). 4. Powe A, Gal RL, Beck RW, Mannis MJ, Holland EJ on behalf of the Cornea Donor Study Investigator Group. The Cornea Donor Study. Vision Pan- America 2009; 8: Sugar A, Tanner JP, Dontchev M, Tennant B, Schultze RL, Dunn SP, Lindquist TD, Gal RL, Beck RW, Kollman C, Mannis M, Holland E, for the Cornea Donor Study Investigator Group. Recipient risk factors for graft failure in the Cornea Donor Study. Ophthalmology 2009; 116: Dunn SP, Stark WJ, Stulting RD, Lass JH, Sugar A, Pavilack MA, Smith PW, Tanner JP, Dontchev M, Gal RL, Beck RW, Kollman C, Mannis MJ, Holland EJ on behalf of the Cornea Donor Study Investigator Group. The effect of ABO blood incompatibility on corneal transplant failure in conditions with low risk of graft rejection. American Journal of Ophthalmology 2009; 147: (Published). 9. Benetz BA, Gal RL, Ruedy KJ, Rice C, Beck RW, Lass JL for the Cornea Donor Study Group. Specular microscopy ancillary study methods for donor endothelial cell density determination of Cornea Donor Study images. Current Eye Research 2006; 31: Cornea Donor Study Group. Clinical profile and early surgical complications in the Cornea Donor Study (CDS). Cornea 2006; 25(2): (Published). 11. Cornea Donor Study Group. Baseline donor characteristics in the Cornea Donor Study (CDS). Cornea 2005; 24(4): Cornea Donor Study Group. An evaluation of image quality and accuracy of eye bank measurement of donor cornea endothelial cell density in the Specular Microscopy Ancillary Study. Ophthalmology 2005; 112: (Published). 13. Beck RW, Gal RL, Mannis MJ, Holland EJ, Cavanagh HD, Foulks GN, Heck EL, Lindquist T, Macsai MS, Smith RE, Stark WJ, Stulting RD, Sugar J. Is donor age an important determinant of graft survival?. Cornea 1999; 18(5): (Published). 14. Stulting RD, Sugar A, Beck RW, Belin M, Dontchev M, Feder RS, Gal RL, Holland EJ, Kollman C, Mannis MJ, Price F, Stark WJ, Verdier DD for the Cornea Donor Study Investigator Group. Effect of donor and recipient factors on corneal graft rejection. Cornea (Accepted). 15. Sugar A, Montoya M, Beck RW, Cowden JW, Dontchev M, Gal RL, Kollman C, Malling J, Mannis MJ, Tennant B for the Cornea Donor Study Investigator Group. Impact of the Cornea Donor Study (CDS) on Acceptance of Corneas from Older Donors. Cornea (Accepted). 7. Cornea Donor Study Investigator Group. Donor age and corneal endothelial cell loss five years after successful corneal transplantation: specular microscopy ancillary study results. Ophthalmology 2008; 115: (Published). 8. Cornea Donor Study Investigator Group. The effect of donor age on corneal transplantation outcome: results of the cornea donor study. Ophthalmology 2008; 115:

6 Consent/Donor Development Consent/Donor Development Cornea donation from patients deceased at a palliative care unit. Stiel S, Hermel M, Radruch L. Palliative Medicine Describes a novel donation setting Consent for corneal donation: the effect of age of the deceased, registered intent and which family member is asked about donation Lawlor M., Dobbins T, Thomas KA, Billson F. British Journal of Ophthalmology Austrailian study that found higher consent for older donors. Implications for donor development resource allocation. Also found that donors with an intent to donate on their driver s license had a family that was more willing to donate. Not terribly shocking but useful to have something we assume to be true validated. Consent/Donor Development Tissue Recovery Donor Prep Cornea donation: evaluation of a training session to obtain consent by telephone Geissier A, Gerbeaux PR, Maitrejean C, Durand Gasselin J. et al. Transplant Proceedings Consent rate improved from 30% to 70% after 100 contacts! Useful for hospital development, budgeting for training and staff retention. Very helpful to have these kinds of studies in the literature and not enough is out there. Any eye bank that obtains consent could participate in something like this. Preparation of corneal donor eyes comparing 1% versus 5% povidone-iodine Lindquist TD, Maxwell AJ, Miller TD et al. Cornea Shows equivalence of 1% and 5% P-I (recommends 1% due to lower toxicity to cornea) Heavy eye bank involvement using culturing to demonstrate efficacy equivalency Improvement to tissue recovery/validation of decontamination 6

7 Tissue Processing/Surgeon Education/Stewardship Tissue Processing- Graft Thickness Descemet Stripping Automated Endothelial Keratoplasty Using Infant Donor Tissue Kim P, Yeung S, Lichtinger A, et al. Cornea 2012 Describes successful use of infant donor tissue for EK and potentially expands the use of tissues from very young donors Graft profile thickness as a function of cut transition speed in Descemet-stripping automated endothelial keratoplasty Bhogal MS, Allan BD, Journal of Cataract and Refractive Surgery - April 2012 Thinner grafts with a slower pass Thicker grafts with a faster pass Tissue Processing Regulatory Compliance/Tissue Processing / Environmental Control Measurements of Microkeratome Cuts in Donor Corneas with Ultrasound and Optical Coherence Tomography Tang M, Ward D, Ramos JLB, et al. Cornea Anyone interested in using OCT for pachymetry measurements now has a reference (OCT deemed not as predictable as USP for corneas >600µm Any eye bank that has these two measuring devices could replicate this study Minimizing the risk of disease transmission during corneal tissue processing Lindquist TD, Miller TD, Elsen JL, et al (from the Policy and Position Research Subcommittee of the EBAA MAB) Cornea 2009 Review of current standards with recommendations for practices based on the review. Great resource for establishments engaged in tissue processing outside a laminar flow hood 7

8 Scientific Basis for Regulation Tissue Processing / QA Guidelines for preventing dilution false negatives in in vitro laboratory testing of the donor population Heck, EL, Baxter CR. Cornea Just where did our hemodilution algorithm come from? Impact of Eye Bank Lamellar Tissue Cutting for Endothelial Keratoplasty on Bacterial and Fungal Corneoscleral Donor Rim Cultures After Transplantation Rauen MP, Goins KM, Sutphin JE, et al. Cornea 2012 No increased risk of bacterial or fungal contamination from corneas precut by eye bank personnel Collaboration between eye bank and transplanting surgeons Processing / Innovation Outcomes Excimer Laser Smoothing of Endothelial Keratoplasty Grafts Cleary C, Liu Y, Tang M, et al. Cornea 2012 Laboratory feasibility study demonstrating smooth interface and safety of procedure prior to clinical trial (posits that the interface may play a significant role in postoperative visual quality) Lots of collaboration, but eye bank participation is key for this study (used precut grafts) Corneal regrafting after endothelial keratoplasty Li JY, Wilhelmus KR. Cornea Eye bank data determines regraft rate 8

9 Donor Trends Process Validation/Innovation The New Zealand National Eye Bank Study: Trends in the Acquisition and Storage of Corneal Tissue over the Decade 2000 to 2009 Cunningham WJ, Moffatt LS, Brookes NH, et al. Cornea donors in 10 years, 64% male, 36% female Does this kind of information look familiar? These kind of data are valuable and with modern eye bank databases retrospective analyses can find new understandings of our field. Caveat: Don t re-report what is already available! This study shows that New Zealand men have lower cell counts than women. Protocol for Vital Dye Staining of Corneal Endothelial Cells Park S, Fong A, Cho H, et al. Cornea Same technique as used in the excimer smoothing paper only staining is better described This is really not that difficult to try and can be used for all sorts of things (technician training verification, slit lamp training adjunct, combined with Photoshop for damage quantification) Other Opportunities Group Exercise Storage (Where did 2-8 come from anyway?) Financial Cost effectiveness studies (a shout out to all the MBAs in the audience) Regulatory (proving that a regulation either makes sense or does not add any safety to the tissue) Anything else? Be open to any idea. Discuss in groups of 6-8 people. Consider: What is exciting? What does your eye bank do well? Could research help support a strategic goals your organization has? 9

10 Possible Topics Areas to Discuss Comments to Inspire A few ideas Tissue processing, evaluation, storage Donor eligiblity Quality assurance Validation Eye banks possess an untapped vein of rich information about donors, corneas, eye banking techniques, and even outcomes. The majority of proposals brought to the Medical Advisory Board arise from observations made by eye bankers in the everyday course of operations. Sometimes what appears to be a unique occurrence turns out to be a trend, and closer examination leads to an entirely new approach. Comments to Inspire cont. Comments to Inspire cont. During my tenure on the MAB, I ve seen really critical and useful data presented regarding tissue viability and storage times and temperatures, sterility standards for tissue processing, and the relationship between donor cultures and the transmission of infection. Some of these observations have led to to publication in the ophthalmic literature. Sadly, others are lost to the wider medical community due to lack of an appropriate publishing process. With the launch of the International Journal of Eye Banking, there is now an outlet for this information that is specifically geared to the topic. The presence of IJEB and the opportunity for collaboration with fellow eye banks for data collection offers a real opportunity to answer questions of importance to eye bankers, to advance the science of eye banking, and to get the word out to the rest of eye banking and scientific community. David Glasser, MD, MAB Chair 10

11 Resources Resources Guide to Scientific Writing m/ccgsw/pages/default.aspx# Guide to Manuscript Review _chem/ccgrw/pages/default.aspx# An Instructional Guide for Peer Reviewers of Biomedical Manuscripts (free online tutorial) ebfiles/images/journals/ymem/index.html Open Access Overview view.htm#peerreview Resources Resources Look in Your Area Directory of Open Access Publications Getting the best answer step by step MH / Understanding research results th/understanding-research-results/ My Research Assistant (MyRA) - Utah 11

12 International Journal of Eye Banking Contacts Open access, peer-reviewed, quarterly online publication. First issue in Register here at EBAA (subscribe free) Participate Share ideas with each other / journal Do research, submit it for publication Jackie Malling, CEBT, RN vanho004@umn.edu Chris Stoeger, CEBT chris@visiongift.org Michael Titus, CEBT mstitus@mebtc.org Jennifer Li, MD jennifer.li@ucdmc.ucdavis.edu 12