1. No category

Version No: 1.3
Ver.Date: 24 January 2011
Healthcare Performance Measurement &
Reporting for LASIK surgery
Page 1 of 11
Protocol No.:HR2010-02
MAIN PROTOCOL
Healthcare Performance Measurement & Reporting System (HPMRS).
Developing healthcare performance measurement and reporting system for purposes of
accountability, quality improvement and population health
Protocol number:
NMRR ID
Date approved by MREC
HR2010-01
NMRR 10-982-7687
17 December 2010
SUB-PROTOCOL
Title: Healthcare Performance Measurement & Reporting for LASIK surgery
services provided by OPTIMAX Malaysia
Protocol number:
HR2010-02
Author(s):
Stephen Chung SH MS.Ophth, Chuah KL FRCOphth, NorAzlina
BN MS.Ophth, Yen SS MS.Ophth, Lim TO FRCP, M.Stat
Document type:
Research Protocol
Document status:
Draft
Release Date:
24 January 2011
Sponsor-Investigator
Optimax and Stats Consulting
Number of pages:
11
This protocol is accompanied by and/or incorporates the following amendment(s):
Amendment No.
Date of Amendment
Author’s Initials
1
Version No: 1.3
Ver.Date: 24 January 2011
Healthcare Performance Measurement &
Reporting for LASIK surgery
Page 2 of 11
Protocol No.:HR2010-02
Contents
Title: Healthcare Performance Measurement & Reporting for LASIK surgery services
provided by OPTIMAX Malaysia ...................................................................................................1
Introduction & Rationale .................................................................................................................3
Goals for LASIK surgery services ...................................................................................................4
Performance measures for LASIK surgery services ........................................................................4
Data specifications and Standard terminology ................................................................................5
Data collection & management ........................................................................................................6
Statistical methods ...........................................................................................................................6
Healthcare performance report ........................................................................................................6
Ethics and Regulatory considerations ................................................................................. 6
Administrative matters ........................................................................................................ 6
Reference .........................................................................................................................................7
Glossary ...........................................................................................................................................8
Appendix: Data Abstraction Form .................................................................................................10
Appendix: Investigator’s Curriculum Vitae...................................................................................11
2
Version No: 1.3
Ver.Date: 24 January 2011
Healthcare Performance Measurement &
Reporting for LASIK surgery
Page 3 of 11
Protocol No.:HR2010-02
Introduction & Rationale
Laser-Assisted In-Situ Sub-Epithelial Keratomileusis or LASIK in short, is a surgical
technique for the correction of myopia, hyperopia and astigmatism. It involves the use of
excimer laser to ablate corneal tissue thus reshaping it in order to correct the refractive
error. LASIK [1,2] has evolved from a variety of techniques including lamellar
keratoplasty, photorefractive keratectomy, and since the 1990s has been widely used. The
technology associated with the LASIK procedure has also advanced rapidly since. Recent
innovations include new microkeratome, newer laser technology (scanning lasers, eyetracking system etc), wavefront custom ablation, phakic intraocular lenses. Numerous
prospective randomized controlled trials and meta-analyses of these trials have
demonstrated the safety and efficacy of LASIK for the correction of refractive errors [311].
Refractive surgery was first introduced into Malaysia by Optimax in 1995. Since then its
use has increased rapidly with the vast majority of the procedures still being performed
by Optimax. Optimax has also grown from a single centre with a lone surgeon to become
the leading provider of LASIK and other specialist eye care services in Malaysia with a
network of 12 centers and 9 ophthalmologists. The Table below shows the volume of
procedures performed by Optimax from 2000.
Year
2000
2005
2006
2007
2008
2009
2010
No. of LASIK
3900
28,000 34,319 40,741 46,689 53,512 58,743
procedures (all types)
Worldwide there is an increasing interest in measuring the performance of healthcare
providers [12,13,14]. The publication of the highly influential report, Performance
Measurement: Accelerating Improvement, by the Institute of Medicine in 2006 [15], has
added greater impetus for performance measurement as a central tenet of health care
reform. Our government has also recently introduced KPI to measure the performance of
government services as part of the Government Transformation Programme [16].
However, this has yet to impact on the public health services where performance
measurement and reporting activity remains undeveloped. Similarly in the private
healthcare sector, while financial performance measures are well established and
routinely reported, robust healthcare performance measures that reflect the core business
of the healthcare industry are practically non-existent.
As a testament to Optimax’s leadership position in the field of LASIK surgery services in
Malaysia, Optimax has agreed to subject its LASIK services to performance
measurement and reporting by an independent third party. This is intended not just to
support quality improvements initiatives within Optimax, but also as a reflection of
Optimax’s commitment to a high standard of accountability in healthcare. To this end,
measuring and reporting the performance of Optimax’s LASIK surgery services is
intended to assure healthcare payers (insurance companies, employers) that they are
getting value for their money, to respond to the requirements of quality certification/
accreditation organizations (ISO9000, JCI) and regulators (CKAP MOH), and most
importantly to aid customers, both patients as well as health professionals who refer
patients, in making informed choices.
3
Version No: 1.3
Ver.Date: 24 January 2011
Healthcare Performance Measurement &
Reporting for LASIK surgery
Page 4 of 11
Protocol No.:HR2010-02
Goals for LASIK surgery services
1. To maintain a consistently high level of visual acuity and refractive outcomes
obtained by LASIK surgery for the correction of refractive errors
2. To maintain a consistently high level of patient safety associated with LASIK surgery
Performance measures for LASIK surgery services
Relevant performance measures for the goals stated above are specified below:
1. Performance measure
Post-operative Uncorrected visual acuity
Description & Rationale
Acuteness or clearness of vision as measured using a Snellen
chart. This is the most commonly used measure to evaluate
visual acuity outcome of LASIK surgery services; just as it is
the most well accepted efficacy measure in clinical trial of
LASIK surgery.
Period of care
At the time of LASIK surgery and continued throughout the
period of care being assessed
Denominator
All patients undergoing LASIK surgery for correction of
myopia at an Optimax centre
Numerator
Number of patients with uncorrected visual acuity (UCVA)
6/12 or better at 6 months post-op
Data sources
Patient medical record
Operating room record
Performance
measure
2.
Post-operative Refraction within +0.5 Diopters of target
Refraction
Description & Rationale
Measure of the precision of the refractive correction
This is the most commonly used measure to evaluate refractive
outcome of LASIK surgery services; just as it is a well accepted
efficacy measure in clinical trial of LASIK surgery.
Period of care
At the time of LASIK surgery and continued throughout the
period of care being assessed
Denominator
All patients undergoing LASIK surgery for correction of
myopia at an Optimax centre
Numerator
Number of patients with mean spherical equivalent within +0.5
Diopers of target refraction at 6 months post-op
Data sources
Patient medical record
Operating room record
3. Performance measure Loss of visual acuity
Description & Rationale
Visual acuity as measured using a Snellen chart.
Loss of 2 or more lines post-op is commonly used to evaluate
loss of visual acuity as a measure of patient safety, just as it is
the most well accepted safety measure in clinical trial of
LASIK surgery.
Period of care
At the time of LASIK surgery and continued throughout the
period of care being assessed
Denominator
All patients undergoing LASIK surgery for correction of
myopia at an Optimax centre
4
Version No: 1.3
Ver.Date: 24 January 2011
Numerator
Data sources
Healthcare Performance Measurement &
Reporting for LASIK surgery
Page 5 of 11
Protocol No.:HR2010-02
Number of patients with loss of 2 or more lines of Best
spectacle Corrected Visual Acuity (BCVA) at 6 months post-op
Patient medical record
Operating room record
Data specifications and Standard terminology
# Variable name
Definition
ID & Demographics
1. Name & ID#
Name & Identification #
2. Age
Age in years
3. Gender
Male or female
4. Prior refractive surgery
Previous surgery for refractive error
5. Pupil size
Size of the pupil in mm as measured using Colvard
Pupilometer or Autorefractometer
Ophthalmic
measurements
6. Visual acuity
Uncorrected and Best corrected visual acuity as measured
using vision chart pre-op and thereafter during the period
of care being assessed
7. Spherical error
Manifest and Cycloplegic spherical error in Diopter
measured pre-op and thereafter during the period of care
being assesse
8. Cylindrical error
Manifest and Cycloplegic cylindrical error in Diopter
measured pre-op and thereafter during the period of care
being assesse
9. Spherical Equivalent
Calculated from Spherical and Cylindrical error
measurements by the formula Spherical Equivalent=
Spherical Error + 0.5 Cylindrical error
10. Corneal curvature
Curvature of the cornea in Diopter as measured using
(Keratometry)
autorefractometer
11. Corneal thickness
Thickness of the cornea in micron as measured using
Orbscan or Sonogage Pachymeter
12. Intra-ocular pressure
Intra-ocular pressure in mmHg as measured using Non
Contact Tonometer or Tonopen
LASIK surgery
13. Type
These are traditional LASIK and newer variations such as
LASEK, Epi-LASIK and INTRALASIK .
Refer Glossary for definitions
14. LASIK machine
Excimer, WaveLight ALLEGRETTO WAVE®, Eye-Q
15. Enhancement
Re-operation for under or over-correction
5
Version No: 1.3
Ver.Date: 24 January 2011
Healthcare Performance Measurement &
Reporting for LASIK surgery
Page 6 of 11
Protocol No.:HR2010-02
Data collection & management
The following data related tasks will be developed to enable healthcare performance
measurement and reporting. Suitably qualified consultants and contractors (CRO, IT
vendor, Auditor etc) will be appointed to perform some of these tasks :
#
Tasks
1. Data definition
2. Data collection form
3. Study procedures & Data flow process.
4. IT infra, eData Submission and eDAF (CRF)
5. Data QA
6. Data audit
Statistical methods
Refer main Protocol
Healthcare performance report
Refer Appendix of the main Protocol for the structure and format of performance report
Ethics and Regulatory considerations
Refer main protocol
Administrative matters
Refer main protocol
6
Version No: 1.3
Ver.Date: 24 January 2011
Healthcare Performance Measurement &
Reporting for LASIK surgery
Page 7 of 11
Protocol No.:HR2010-02
Reference
1. Pallikaris IG, Papatzanaki ME, Stathi EZ, et al. Laser in situ keratomileusis. Lasers
Surg Med 1990;10:463– 8.
2. Pallikaris IG, Papatzanaki ME, Siganos DS, Tsilimbaris MK. A corneal flap
technique for laser in situ keratomileusis: human studies. Arch Ophthalmol
1991;109:1699 –702.
3. El-Maghraby A, Salah T, Waring GO 3rd, et al. Randomized bilateral comparison of
excimer laser in situ keratomileusis and photorefractive keratectomy for 2.50 to 8.00
diopters of myopia. Ophthalmology 1999;106:447–57.
4. El Danasoury MA, El Maghraby A, Klyce SD, Mehrez K. Comparison of
photorefractive keratectomy with excimer laser in situ keratomileusis in correcting
low myopia (from _2.00 to _5.50 diopters). A randomized study. Ophthalmology
1999;106:411–20
5. Carr JD, Stulting RD, Sano Y, et al. Prospective comparison of single-zone and
multizone laser in situ keratomileusis for the correction of low myopia.
Ophthalmology 1998;105:1504–11.
6. Hersh PS, Brint SF, Maloney RK, et al. Photorefractive keratectomy versus laser in
situ keratomileusis for moderate to high myopia. A randomized prospective study.
Pphthalmology 1998;105:1512–22.
7. Steinert RF, Hersh PS. Spherical and aspherical photorefractive keratectomy and laser
in-situ keratomileusis for moderate to high myopia: two prospective, randomized
clinical trials. Summit technology PRK-LASIK study group. Trans Am Ophthalmol
Soc 1998;96:197–221
8. Hersh PS, Abbassi R. Surgically induced astigmatism after photorefractive
keratectomy and laser in situ keratomileusis. Summit PRK-LASIK Study Group. J
Cataract Refract Surg 1999;25:389–98.
9. Hersh PS, Scher KS, Irani R. Corneal topography of photorefractive keratectomy
versus laser in situ keratomileusis. Summit PRK-LASIK Study Group.
Ophthalmology 1998;105: 612–9.
10. Sugar A, Rapuano CJ, Culbertson WW, Huang D, et al. Laser In Situ Keratomileusis
for Myopia and Astigmatism: Safety and Efficacy. A Report by the American
Academy of Ophthalmology. Ophthalmology 2002;109:175–187
11. Shortt AJ, Bunce C, Allan BDS. Evidence for Superior Efficacy and Safety of LASIK
over Photorefractive Keratectomy for Correction of Myopia. Ophthalmology
2006;113:1897–1908
12. Chassin MR, Loeb JM, Schmaltz SP, Wachter RM. Accountability Measures — Using
Measurement to Promote Quality Improvement. N Engl J Med 2010;363;683-688
13. NHS Modernisation Agency. 2003. Real Measurement for Real Improvement Using
Statistical Process Control. [Online]. Available: http://www.modern.nhs.uk/search/.
14. Australian Council for Safety and Quality in Healthcare. 2004. Safety and Quality
Council. [Online]. Available: http://www.safetyandquality.org/index.cfm.
15. Institute of Medicine. Performance measurement: accelerating improvement.
Washington, DC: The National Academies Press; 2006
16. The Government Transformation Programme Available at:
http://www.pemandu.gov.my/index.php?option=com_content&view=article&id=601
&Itemid=83&lang=en
7
Version No: 1.3
Ver.Date: 24 January 2011
Healthcare Performance Measurement &
Reporting for LASIK surgery
Page 8 of 11
Protocol No.:HR2010-02
Glossary
This section defines the various technical terms found in this protocol/ report in simple
non-technical language for the benefits of readers unfamiliar with the subject matter
under investigation.
Accountability
The requirement that healthcare providers who have voluntarily
taken on the responsibility to provide healthcare services and are so
accredited or licensed, and to whom the necessary authority and
resources are provided in order for them to discharge their
responsibility, be held answerable for results
Astigmatism
One form of refractive error where the focusing power of the eye is
only affected in one meridian than it is in another.
Epi-LASIK
The Epi-LASIK procedure employs a unique microkeratome, called
the "Epikeratome", to mechanically "separate" the epithelium from
the stroma, creating a flap of epithelial cells only (Epi-flap). Unlike
LASIK, no sharp blades or knives are required and unlike LASEK,
no alcohol is required. The Epi-flap is moved aside so that the laser
can reshape the exposed cornea. After laser application, the Epiflap
is replaced over the corneal bed and a bandage soft contact lens is
placed on top at the end of procedure.
Healthcare
Refers to both institutional providers of health care services (e.g.,
providers
clinics, hospitals, nursing homes) and clinicians (e.g., physicians,
nurse practitioners, nurses, physician assistants).
Hyperopia
One form of refractive error where the optical power of the eye is
too weak to focus light on the retina. This can arise from a cornea
with too little curvature or an eyeball that is too short
INTRALASIK
IntraLASIK is a procedure that similar to LASIK where corneal flap
is created for laser ablation. However in this procedure, flap is
created using femtosecond laser instead of mechanical blade
(microkeratome)
The procedure uses a software to direct the Femtosecond laser to
optically focus its beam into a tiny, 1 micron (.001mm) spot of
energy that passes harmlessly through the outer layers of the cornea
until reaching its exact depth within the stroma (central deeper layer
of the cornea). The laser beam creates a separation plane by forming
an interconnecting series of bubbles made of carbon dioxide and
water vapor.
The laser beam stacks a pattern of bubbles along the periphery of
the treatment plane, leaving a separated section of tissue to act as a
hinge. As with a traditional LASIK approach, the surgeon then folds
the tissue back to expose the underlying corneal layer to prepare for
the excimer laser treatment that will re-shape the cornea. With AllLaser-Lasik, surgeons can avoid the complications related to
surgical blade problems. The Femtosecond laser precisely delivers
the laser energy directly to the outer surface of the eye, which
suffers no trauma.
LASEK
Laser epithelial keratomileusis or LASEK is a modified form of
8
Version No: 1.3
Ver.Date: 24 January 2011
LASIK
Myopia
Performance
Performance
measure
Refractive error
Refractive surgery
Risk adjustment
Visual acuity
Healthcare Performance Measurement &
Reporting for LASIK surgery
Page 9 of 11
Protocol No.:HR2010-02
photorefractive keratectomy (PRK). This procedure requires the
outer layer of the cornea- epithelium to be loosened with the diluted
alcohol solution for around 30 seconds. Then the loosened
epithelium (Epi-flap) is moved aside so that the laser can reshape
the exposed cornea. After laser application, the Epi-flap is replaced
over the corneal bed and a bandage soft contact lens is placed on top
at the end of procedure.
Laser-assisted in situ keratomileusis
A surgical procedure for the correction of refractive error.
A circular superficial cornea flap is made initially with a
mircokeratome (a special steel blade). The flap is then folded back
to allow a type of laser (excimer laser) to ablate and reshape the
deeper layers (stroma) of the cornea according to the patient’s
spectacles prescription. Following laser ablation, the flap is
repositioned and will adhere itself naturally without the need for
stitches.
One form of refractive error in which the focusing power
(refraction) of the eye is too strong such that when viewing distant
object, the image of the viewed object is brought into focus in front
of the retina rather than on it. Myopia can arise from a cornea with
too much curvature or an eyeball that is too long
The activity of a healthcare provider intended to accomplish the
goals of healthcare. These goals are healthcare should be safe,
effective, patient-centered, timely, efficient, and equitable.
Performance Measures are those measures of process, structure,
efficiency, or outcome that have been developed using rigorous
methodology , and are intended not only for clinical quality
improvement but they have attributes rendering them suitable for
public reporting, explicit comparisons of care between healthcare
providers, accreditation, pay for performance programs, or other
forms of accountability.
An error in the focusing of light on the retina (this is back portion of
the eye) and a frequent reason for reduced visual acuity.
Changing a patient's optical measurements for the purpose of
correction of refractive error by means of an operation
A process that modifies the analysis of performance measurement
results by those elements of the patient population that affect
results, are out of the control of providers, and are likely to be
common and
not randomly distributed
Acuteness or clearness of vision. It is often measured according to
the size of letters viewed on a Snellen chart
9
Version No: 1.3
Ver.Date: 24 January 2011
Healthcare Performance Measurement &
Reporting for LASIK surgery
Page 10 of 11
Protocol No.:HR2010-02
Appendix: Data Abstraction Form
10
Version No: 1.3
Ver.Date: 24 January 2011
Healthcare Performance Measurement &
Reporting for LASIK surgery
Page 11 of 11
Protocol No.:HR2010-02
Appendix: Investigator’s Curriculum Vitae
11