Download Self-Directed Non-Clinical QI Application (Part One

ABO CLINICAL QUALITY IMPROVEMENT (QI) APPLICATION
Topic
Quality Improvement Topic:
Screen for IFIS Risk Factors
Intraoperative floppy iris syndrome (IFIS) is characterized by a billowing of the
iris stroma, iris prolapse, and progressive intraoperative mitosis. This triad is
linked with current or past use of alpha-1 adrenergic receptor antagonists (?1ARAs), such as tamsulosin, terazosin, and doxazosin. These agents are
commonly prescribed in men to reduce urinary outflow obstruction secondary to
benign prostatic hyperplasia (BPH). It is hypothesized that
(?-1ARAs) cross-react with receptors in the iris dilator muscle, leading to loss of
iris muscle tone and atrophy. Patient exposure to (?-1ARAs) has been shown to
increase the incidence of serious cataract surgery complications, even with
experienced surgeons.
Resident-performed cataract surgeries are traditionally associated with higher
rates of complications (posterior capsular disruption, vitreous loss) than those
performed by experienced surgeons. In a single hospital setting, complication
rates in excess of 15% were observed for resident-performed (attendingsupervised) cataract surgery cases. This rate exceeded complication rates
commonly reported for resident-performed cataract extractions. In order to
reduce rates of cataract surgery complications, particular attention to screening
for use of systemic (?-1ARAs) was instituted in patients scheduled for cataract
surgery. If IFIS can be anticipated, potential surgical and pharmacologic
interventions could be employed to potentially reduce the risk of intra-operative
complications in resident-performed cataract surgeries.
Determining if particular interventions prove useful in reducing complications
and improving outcomes is important, because pre-operative discontinuation of
(?-1ARAs) has not been shown to reduce the incidence of IFIS.
What is the reach of this QI activity?
National
Please explain/identify:
Alpha-1 adrenergic receptor antagonists (?-1ARAs), such as tamsulosin,
terazosin and doxazosin, are commonly prescribed in men to treat urinary
outflow obstruction due to benign prostatic hyperplasia (BPH). BPH is the
most common disorder of the prostate. These medications (?-1ARAs) are now
known to cause intraoperative floppy iris syndrome (IFIS), a condition known
to make cataract surgery more complex and lead to a higher rate of surgical
complications.
This activity will evaluate if screening for (?-1ARAs) is worthwhile and
determine if implementation of particular pharmacologic interventions (e.g.,
pre-operative atropine, intracameral epinephrine) and surgical strategies
(e.g., use of iris hooks) leads to reduced surgical complications and improved
cataract surgery outcomes.
Please identify the funding source(s) for
this QI activity?
None
Project Description
1. Describe the quality gap or issue addressed
by this activity. (Included in your response to
this question should be a description of the
resources that informed your decision to
pursue this topic, a description of what the
literature says about the issue you identified,
and the rationale for choosing to address this
clinical QI project.)
Resident-performed cataract surgeries are traditionally associated with higher
rates of complications than those performed by more experienced surgeons.
Recent reports of vitreous loss rates following resident cataract surgery have
ranged from 1.9% to 14.7% (Quillen et al 2003; Bhagat N et al 2007; Randleman
et al. 2007; Rogers et al 2009; Rutar et al. 2009). Over a greater than 6-month
period, the resident complication rate at a single VA hospital rose above 15%.
One policy that was implemented by the cataract attending staff to address the
complication rate was to institute
pre-operative screening for use of systemic alpha-1 adrenergic receptor
antagonists (?-1ARAs), medications typically used to reduce urinary outflow
obstruction in patients with benign prostatic hyperplasia (BPH). This was
secondary to greater attention being placed on the role tamsulosin, an ?-1ARA, in
causing intraoperative floppy iris syndrome (IFIS) (Chang et al 2005). IFIS, which is
characterized by a billowing of the iris stroma, iris prolapse, and progressive
intraoperative miosis, had been shown to lead to more complex cataract surgery
and a higher rate of complications.
Following the institution of screening for systemic ?-1ARAs, options for
consideration of the surgical team included use of pharmacologic (e.g., preoperative topical atropine, intracameral epinephrine) and surgical (e.g., iris
hooks) interventions. No specific intervention was mandated.
This activity is designed to first to assess the prevalence of use of tamsulosin
as well as other (?-1ARAs) in order to determine if this element of pre-operative
screening is worthwhile at this hospital.
Secondly, the activity should assess whether additional interventions
(pharmacologic and surgical) were, in fact, implemented in cases in which the
patients were known to be on
(?-1ARAs) relative to those not on these medications. Finally, the activity should
address whether these interventions lead to lower complication rates, and to
see if any particular intervention is more successful in reducing complications.
1. Quillen DA, Phipps SJ. Visual outcomes and incidence of vitreous loss for
residents performing phacoemulsification without prior planned
extracapsular cataract extraction experience. Am J Ophthalmol 2003;
135(5):732-3.
2. Bhagat N, Nissirios N, Potdevin L, et al. Complications in residentperformed phacoemulsification cataract surgery at New Jersey
Medical School. Br J Ophthalmol 2007; 91(10):1315-7.
3. Randleman JB, Wolfe JD, Woodward M, et al. The resident surgeon
phacoemulsification learning curve. Arch Ophthalmol 2007; 125(9):12159.
4. Rogers GM, Oetting TA, Lee AG, et al. Impact of a structured surgical
curriculum on ophthalmic resident cataract surgery complication rates. J
Cataract Refract Surg 2009; 35(11):1956-60.
5. Rutar T, Porco TC, Naseri A. Risk factors for intraoperative complications
in resident-performed phacoemulsification surgery. Ophthalmology
2009; 116(3):431-6.
6. Chang DF, Campbell JR. Intraoperative floppy iris syndrome
associated with tamsulosin. J Cataract Refract Surg 2005; 31(4):66473.
2. Describe the specific aim(s) of this
activity (explanation of the numeric goals
and importance to your work processes and
your organization).
This activity aims to evaluate several issues, including assessing the
prevalence of use of systemic (?-1ARAs) in a VA patient population and whether
screening of patients for use of systemic (?-1ARAs) with attention to potential
surgical and pharmacologic interventions can lead to outcomes similar to
patients without prior use of (?-1ARAs).
The records of a consecutive series of patients undergoing cataract surgery at a
single VA hospital will be studied. Based on the focus of patients potentially on (?1ARAs) for benign prostatic hyperplasia, the activity will include all male patients
50 years of age and above undergoing cataract surgery. To minimize any potential
bias in the analysis, planned combined cases (e.g., cataract
extraction/trabeculectomy) will not be included.
Goals of this activity will include 1) whether complication rates less than
10% can be achieved for resident-performed
(attending-supervised) cataract surgeries at this hospital, and 2) whether
complication rates in patients on (?-1ARAs) can be no greater than in patients
without any exposure to (?-1ARAs), and 3) whether particular pharmacologic
or surgical interventions performed in patients on systemic (?-1ARAs)
undergoing cataract surgery positively impacts outcomes and reduces
complication rates.
The activity ideally will assess at least 500 cataract cases and include at least 75
cases of patients on (?-1ARAs). Based on the number of cases performed
annually and the criteria specified, this activity will encompass analysis of ~ 2-4
years of cataract surgery cases in order to draw meaningful conclusions and
answer the aims of the activity.
3. Identify the measures that were
evaluated in your workplace and provide
a summary of pre- and post-intervention
data for each measure. (Please provide
source information for each measure.)
Several measures will be evaluated in this activity. Measures will include
complication rates, including vitreous loss rates, which will be obtained
from operative notes. The need for reoperation within 90 days of
cataract surgery will also be obtained from operative reports and patient
records. Post-operative visual acuity (best corrected visual acuity, BCVA)
will also be evaluated based on patient records.
4. What was the source of your data (check
all that apply)?
Electronic Medical Record
Administrative Data
5. What methods were used for data
collection (check all that apply)?
Retrospective Chart Review
Electronic Medical Record
6. What was the comparison group in this
activity (e.g., a regional or national
benchmark)?
This activity will look at rates of cataract surgery complications in patients on
systemic (?-1ARAs) and those who have not been exposed to these medications.
This will be an internal comparison group. In addition, rates will also be compared
to overall complication rates published in the peer-reviewed literature. In addition
to complication rates, the overall use of (?-1ARAs) in this VA patient population will
be compared to other published rates in the literature.
7. Will the identified measures address
important issues for your processes of care
and/or patients?
Yes
8. Describe the process you went through to
develop the QI plan and the tests of change
that will be undertaken to improve care (i.e.,
quality improvement plan design,
implementation, and re-evaluation).
Resident-performed (attending-supervised) cataract surgeries are traditionally
associated with higher rates of complications than those performed by more
experienced surgeons. Over a greater than 6-month period, the residentperformed cataract surgery complication rate at a single VA hospital rose above
15%. This was a significantly greater rate than those for experienced surgeons and
a greater rate than the published rates for resident-performed cataract surgeries at
other institutes.
One policy that was implemented by the cataract attending staff to address the
complication rates was to institute pre-operative screening for current use or
exposure to systemic (?-1ARAs). This was secondary to greater attention being
placed on the role of (?-1ARA) in causing intraoperative floppy iris syndrome (IFIS),
first reported in 2005 by Chang and Campbell, in causing surgical complications
(Chang et al 2005). In addition, it was also believed that there would be a high rate
of systemic (?-1ARAs) use for benign prostatic hyperplasia (BPH) in this patient
population at a VA hospital.
Instituting the screening was designed to provide the resident and attending
surgeon additional information in planning the surgical case. Ultimately it was up
to the surgical staff whether any additional intervention, such as placement of iris
hooks or a Malyugin ring or intracameral injection of epinephrine, was performed
to improve the stability of the pupil.
It is important to identify if this patient population at a VA hospital does
indeed have a high rate of exposure to systemic (?-1ARAs). It is also
important to know, if with proper screening and planned intervention as
deemed appropriate, whether resident-performed (attending-supervised)
cataract surgery complication rates in patients on (?-1ARAs) can be
maintained at similar rates to those in patients without systemic ?-1ARAs
exposure. Given that a particular intervention was not mandated, it will
also be interesting to discover through this activity whether a particular
intervention, surgical or pharmacologic, may lead to lower complication
rates. Identifying potential interventions in this patient population is
important because pre-operative discontinuation of (?-1ARAs) has not
been shown to decrease the incidence of IFIS (Chang et al 2007).
1. Chang DF, Campbell JR. Intraoperative floppy iris syndrome associated
with tamsulosin. J Cataract Refract Surg 2005; 31(4):664-73.
2. Chang DF, Osher RH, Wang L, Koch DD. Prospective multicenter
evaluation of cataract surgery in patients taking tamsulosin (Flomax).
Ophthalmology 2007; 114(5):957-64.
9. Present baseline data that supports the need
Published reports estimate systemic use of (?-1ARAs) in approximately 5% of
for your change concept, then specify the
patients undergoing cataract surgery. Intraoperative floppy iris syndrome (IFIS) is
intervention(s) that will be implemented in
reported to occur in the majority of cases of patients on tamsulosin, an a1ARA
your practice and why they were chosen.
commonly prescribed to treat benign prostatic hyperplasia (BPH). IFIS is known to
lead to more complex cataract surgery and a greater rate of surgical complications.
Over a 6-month period, the complication rates of resident-performed
(attending-supervised) cataract surgery exceeded 15% in a single VA
hospital. With the goal of reducing this rate significantly, ideally below
10%, pre-operative screening for use of (?-1ARAs) was instituted. In a VA
hospital setting, the initial hypothesis is that there is an even greater
rate of (?-1ARAs) for systemic use for BPH than in the general
population.
The goal was to institute general screening for each cataract surgery patient
in order to ensure optimal care for the patients. In addition, it is not clear if there
is a particular intervention via surgical means (e.g. iris hooks) or pharmacologic
means (e.g., pre-operative topical atropine, intracameral epinephrine) that
reduces the incidence of IFIS and thereby reduces the rate of complications. No
specific intervention was mandated, but the screening calls specific attention to
the attending and surgical team to consider options for each case as deemed
necessary.
Project Outcomes/Results
1. Describe in detail your role in this activity
(i.e., your role in identifying measures and
reviewing data, identifying the QI topic,
developing the QI plan, identifying
interventions, implementing the QI plan and
interventions into your practice, etc.).
I have led the investigation into analyzing the role of exposure to systemic
alpha-1 adrenergic receptor antagonists (?-1ARAs) on complication rates in
resident-performed (attending-supervised) cataract surgery as well as the
differential impact of specific interventions (pharmacological and mechanical) to
reduce complication rates. I designed the current analysis evaluating cataract
complication rates in patients with and without exposure to (?-1ARAs), the
outcome measures utilized, and the impact of specific interventions on
complication rates. I was part of a small group of attending surgeons that had
initially assessed methods to reduce cataract complication rates in our hospital and
had implemented consistent screening for exposure to systemic a-1ARAs use prior
cataract surgery.
2. Were other members from your care team
involved in this activity?
Yes
If yes, please describe their role(s) in this
activity.
I was part of a small group of attending cataract surgeons that had reviewed
complication rates and instituted screening for systemic ?-1ARA exposure at
our hospital. The rest of this group is aware of but has not been directly
involved with the subsequent design of this activity to evaluate the outcomes
of that screening requirement. I did consult with a statistician at the university
department to verify specific methodological questions in making
comparisons for completion of this activity. In addition, a resident physician
assisted in data collection for this activity as together we reviewed >1000
individual electronic patient records (operative reports and clinic visits).
3. Describe the impact this QI effort had on
your practice and the care that you provided
to your patients.
Changes in clinical care were instituted due to a high rate of complications
(>15%) in resident-performed (attending-supervised) cataract surgery at a
particular VA hospital. Key to changes instituted to reduce complication rates (to
less than 10%) were to screen every patient for use of systemic alpha-1 adrenergic
receptor antagonists (?-1ARAs), agents typically prescribed to reduce urinary
outflow obstruction secondary to benign prostatic hyperplasia (BPH). Current or
past use of a-1ARAs has been linked to intraoperative floppy iris syndrome (IFIS)
and has been shown to increase the incidence of cataract surgery complications,
even with experienced surgeons. Given the patient population at a VA institute,
there was also the belief that the exposure rate to ?-1ARAs would be even greater
at our hospital than that typically reported in the literature in general
ophthalmology practices.
Screening for systemic use of ?-1ARAs was performed in the clinic setting and
then reviewed in the pre-operative setting. No specific intervention was
mandated, though the resident and attending team could consider potential
pharmacologic (pre-operative topical atropine, intracameral epinephrine) and/or
surgical (iris hooks, Malyugin ring) interventions to assist based on the knowledge
of specific systemic medication exposure that increases the risk for IFIS and
potential complications.
The added time to screen for patients was minimal and there was adequate
time in the pre-operative area to re-evaluate pupils and consider the need for
possible interventions. Screening for these medications also allowed for additional
discussion during the informed consent process based on increased risk for IFIS to
occur in patients on systemic (?-1ARAs). Screening for systemic medications and a
thoughtful discussion about any additional interventions that should be added to
a surgical procedure designed to improve patient safety only benefited the
patients.
Screening for exposure to systemic (?-1ARAs) did increase the frequency of use
of an intervention, either pharmacologic, surgical, or both to reduce the incidence
of IFIS. The use of any intervention, pharmacologic or surgical, to improve pupil
stability took place in 26.5% (86 out of 324) of patients with prior (?-1ARAs)
exposure. This usage rate was 3-fold greater than the 8.3% rate of use of an
intervention in patients without prior exposure to systemic (?-1ARAs). This
substantial increase was an interesting finding of this activity, as no intervention
was mandated with a positive screening for exposure to systemic (?-1ARAs).
The aims of this activity were to evaluate if the overall complications rates
were reduced as intended by the introduction of (?-1ARAs) screening and to
assess if the rate of complications in patients on (?-1ARAs) could be no greater
than in patients without any exposure to (?-1ARAs). Through this activity, we have
demonstrated that the original goals were met, in that the overall surgical
complication rates were significantly reduced as intended and the complication
rate in the patients with exposure to (?-1ARAs) was similar to the rate in those
patients without exposure to (?-1ARAs) (additional details provided in response to
question #4 below).
4. What data can you provide to demonstrate
that your change concept produced
meaningful improvement in your current
processes or patient outcomes? (I.e.
percentage reduction in post-operative
complication, percentage improvement in a
specific cohort of patients etc.)
The first hypothesis of the current activity was that the exposure rate to
systemic (?-1ARAs) in our patient population was higher than that typically
reported in the literature. Four consecutive years of cataract surgery patients
were assessed in order to meet our target goals of total cataract surgeries as
well as exposure to systemic (?-1ARAs) in order to provide meaningful
feedback. The electronic medical records of 1099 consecutive eyes of unique
male patients 50 years or older undergoing cataract surgery at a single hospital
were reviewed. In this review, 29.5% (324) of male patients 50 years or older
had current or past use of (?-1ARAs). As hypothesized, this observed rate with
our patient population far exceeds rates reported in the literature of
approximately 3-5% (Chang et al. 2005, Chen et al. 2010).
As described in the specific aims, a fundamental goal was to reduce the major
complication rates from >15% to less than 10%. The secondary goal was to
optimize cataract surgery performed in patients on (?-1ARAs) such that the
complication rates in these patients was no greater than the complication rates
in patients not exposed to (?-1ARAs). For purposes of this activity, major
complications were defined to include vitreous loss, retained lens fragment,
retinal detachment (within 90 days), and any need for reoperation within 90
days of initial cataract surgery. The overall major complication rate across all
1099 unique patients was 7.9% (87 eyes). Among the (?-1ARAs), the rate of
major complications was 8.0% (26 eyes) and the rate among the non- ?-1ARAs
was 7.9% (61 eyes). The most common major complication in both groups was
vitreous loss. This data demonstrates that the rate of major complications in
patients undergoing cataract surgery was almost reduced in half. In addition, the
rate of major complications in patients exposed to (?-1ARAs) was no greater than
the rate in those patients without prior exposure to (?-1ARAs) who underwent
cataract surgery. The overall proportion of patients achieving post-operative
BCVA of 20/40 or better within 90 days of surgery was also similar between
those patients with prior (?-1ARAs) exposure (73.4%) and those patients without
prior exposure to ?-1ARAs (70.6%, p=0.67).
1. Chang DF, Campbell JR. Intraoperative floppy iris syndrome
associated with tamsulosin. J Cataract Refract Surg 2005; 31(4):664-73.
2. Chen AA, Kelly JP, Bhandari A, Wu MC. Pharmacologic prophylaxis and risk
factors for intraoperative floppy-iris syndrome in phacoemulsification performed
by resident physicians. J Cataract Refract Surg 2010; 36(6):898-905.
Project Reflection
5. Reflecting on this self-directed clinical QI
project, how do you plan to sustain your
improvement?
This activity has demonstrated the high rate of use of systemic ?-1ARAs in the
patient population and reinforced the need to continue screening for ?-1ARAs.
The use of screening for ?-1ARAs in conjunction with pre-operative assessments
ultimately contributed to the use of an intervention, either pharmacologic or
surgical, in 26.5% (86 out of 324) of eyes. This is considerably higher than the 8.3%
usage rate (64 out of 775 eyes) of a pharmacologic and/or surgical intervention
over the same period in patients that had not been exposed to ?-1ARAs.
As described, no specific intervention was mandated.
Nevertheless, numerical differences in the use of interventions were observed
between the two groups. Surgical intervention (iris hooks or Malyugin ring) was
used in 12% (n=39) of the eyes with systemic
?-1ARA use and in only 3.2% (n=25) of those not exposed to ?-1ARAs (p<0.001).
Pharmacologic intervention (intracameral epinephrine, preoperative atropine)
was performed in 16.4% (n=54) of patients with systemic ?-1ARAs exposure and
in only 5.9% (n=46) of patients not exposed to systemic ?-1ARAs (p<0.001).
Combined pharmacologic and mechanical surgical intervention was used in 2.2%
(n=7 eyes) of ?-1ARAs treated patients relative to 0.9% (n=7 eyes) of non-?-1ARA
exposed patients (p<0.001).
Overall, it is key to continue to screen for systemic ?-1ARAs use. In the ?1ARAs patients in which a surgical (mechanical) intervention was utilized, there
were major intraoperative complications in 2 out of 39 eyes (5.1%). In those
patients exposed to ?-1ARAs who only received pharmacologic therapy, there
were intraoperative complications in 5 out of 47 eyes (10.6%). While there was a
numerically lower rate of complications in those eyes treated with mechanical
surgical intervention (5.1%) relative to those treated with only a pharmacologic
intervention (10.6%), this difference did not achieve statistical significance
(p=0.46, Fishers exact test). These results however, are suggestive that a
mechanical surgical intervention, such as iris hooks or a Malyugin ring, can often
be quite useful in patients with exposure to ?-1ARAs who have the potential to
develop IFIS.
In order to sustain the improvement, it will be critical to ensure that all options
are available to surgeons in the operating room in cases of potential IFIS. In
addition, continued education of residents with the use of mechanical devices
(iris hooks, Malyugin rings) may lead to even lower complication rates in the
future. It will be important that all residents are sufficiently comfortable with the
use of mechanical interventions such that these options are always considered
and never ignored simply due to lack of comfort with the procedure.
It is important to understand upon analyzing this data that there
was potential for bias in that patients who may have had smaller pupils upon
dilation, either on screening or in the operating room, may have been more likely
to receive an intervention. Therefore, the eyes in which an intervention was
performed may have already been the more challenging eyes on which to
perform cataract extraction, and maintaining complication rates no greater than
in the non- ?-1ARAs exposed patients was an accomplishment.
6. Was this clinical QI project beneficial to your
processes, patient population or practice?
The method of screening for ?-1ARAs contributed to reduced complication
rates in resident-performed (attending-supervised) cataract surgery. The overall
complication rate was reduced significantly and was within the range of
complication rates reported by other teaching hospitals (Quillen et al 2003;
Bhagat N et al 2007; Randleman et al. 2007; Rogers et al 2009; Rutar et al. 2009).
While we expected a high rate of systemic ?-1ARAs exposure based on the
patient population of our hospital, the finding that 29.5% of male patients 50
years of age or greater were currently on or had previously been treated with a
systemic ?-1ARAs exceeded our estimates. This reaffirmed the worthwhile
nature of screening for ?-1ARAs exposure in every potential surgical candidate.
In addition to reducing the overall complication rate, the complication rate in
patients previously exposed to ?-1ARAs was no greater than the complication
rate in those not previously exposed to ?-1ARAs. This was achieved without
mandating a particular intervention but rather by simply making sure the
surgical team was aware of the prior exposure to ?-1ARAs, and that careful
pupillary examination and operative planning needed to take place with the
anticipation that IFIS may occur during cataract extraction.
The numerically lower rate of complications in cases in which iris hooks or a
Malyugin ring were implemented relative to pharmacologic intervention alone
was of note despite not reaching statistical significance. The numerical
differences in the interventions were also important given that the cases in
which these interventions were utilized may have been the most challenging.
For the patients in our hospital, this demonstrates the need to always have
these devices available in the operating room. Perhaps, even more important
than having these devices available, this activity has taught us that it is critical to
make sure that every resident is taught to use these devices and has enough
experience with these interventions to be comfortable with use of mechanical
surgical interventions. Despite the expected learning curve inherent with
learning to implement these mechanical surgical interventions (iris hooks,
Malyugin rings), there was no increase in risk of complications from use of these
devices, in many cases for the first time. In fact, the use of these interventions
numerically reduced the rate of complications.
3. Quillen DA, Phipps SJ. Visual outcomes and incidence of vitreous loss for
residents performing phacoemulsification without prior planned extracapsular
cataract extraction experience. Am J Ophthalmol 2003; 135(5):732-3.
Bhagat N, Nissirios N, Potdevin L, et al. Complications in resident-performed
phacoemulsification cataract surgery at New Jersey Medical School. Br J
Ophthalmol 2007; 91(10):1315-7.
Randleman JB, Wolfe JD, Woodward M, et al. The resident surgeon
phacoemulsification learning curve. Arch Ophthalmol 2007; 125(9):1215-9.
Rogers GM, Oetting TA, Lee AG, et al. Impact of a structured surgical curriculum
on ophthalmic resident cataract surgery complication rates. J Cataract Refract
Surg 2009; 35(11):1956-60.
Rutar T, Porco TC, Naseri A. Risk factors for intraoperative complications in
resident-performed phacoemulsification surgery. Ophthalmology 2009;
116(3):431-6.
7. Please describe any lessons learned about
your work processes by participating in this
self-directed clinical QI project?
The findings of this project were very informative. First, this activity did in
fact demonstrate that with knowledge of a patient being exposed to
systemic ?-1ARAs, the surgical team was in fact more likely to utilize an
additional intervention, either pharmacologic, surgical, or both. This was
evidenced by an intervention being used in 26.5% of eyes in patients
exposed to ?-1ARAs as compared to 8.3% of eyes in which patients did not
have prior exposure to ?-1ARAs.
It was also informative to assess what would take place in a situation in
which information was provided to the surgical team, but no specific
guidance was mandated. While there was a threefold greater use of an
intervention in ?-1ARAs patients relative to those without ?-1ARAs exposure,
the vast majority (63.5%) of cataract surgeries in these patients were still
performed without any additional pharmacologic or surgical intervention to
mitigate potential IFIS. The reason that the majority of cases with prior ?1ARAs exposure still did not receive an additional intervention intended to
mitigate IIFIS may be based on limited published data on specific
interventions that effectively reduce complications secondary to IFIS. In
addition, it may also point to the potential that clinical examination of a
pupil that appears to dilate sufficiently may provide a surgical team false
confidence that IFIS will not be an issue and therefore an additional
intervention early on during surgery is not performed.
It was surprising that a surgical intervention, consisting of either placement of
iris hooks or a Malyugin ring, was only used in 12% of eyes. While the use of this
surgical intervention did not achieve a statistically lower complication rates than
pharmacologic interventions, it certainly had a numerically lower rate of
complications. The relative infrequent use of iris hooks or a Malyugin ring may
reflect a general lack of experience or comfort with placing iris hooks or a
Malyugin ring to aid in cataract surgery. This points out the need to ensure that
every resident surgeon is comfortable with these procedures in the future, so
that there is never a decision to avoid an intervention due to lack of prior
experience. It is critical that both iris hooks and Malyugin rings are available in
the operating rooms for use. It is also important that residents are trained on
and comfortable with the use of both iris hooks and Malyugin rings should there
be situations in the future where only one of these options is available for use.
8. What do you plan to do next to improve
i.e. reduce variation in your processes of
care?
The overall goal was to assess if screening for systemic ?-1ARAs was
worthwhile and whether complication rates in patients on ?-1ARAs could be
maintained at a rate no higher than those patients without exposure to ?1ARAs. Given the high rate of systemic ?-1ARAs exposure seen in this project
(29.5%), it becomes clear that this type of screening should remain part of the
pre-operative screening protocol.
Based on the lack of a statistical difference between surgical and
pharmacologic interventions in overall complication rates, it is difficult to
require a specific intervention going forward. In addition, there was the
potential for bias towards particular interventions based on pupil exam and
physician preference within this retrospective analysis. Therefore, requiring
that all surgeries require a specific intervention performed as part of the
regimen does not make sense at this time.
Reflecting on this activity, it does become clear that decisions in the
operative setting may be made based on resident comfort with a particular
intervention/procedure. It is clear that in teaching residents it is our
obligation to ensure that residents are taught and become both comfortable
and adept at a wide array of procedures. Once resident physicians become
facile with placement of iris hooks or a Malyugin ring, these interventions can
be performed without complications and without adversely impacting the
length of a case. It will be important that each resident is specifically taught
how to address non-standard cases such that they have more tools at their
disposal for both preventing complications and addressing complications
when they arise. Developing better ways of teaching surgical techniques is
the next step at continuing to reduce variations and improve process for the
benefits of patients.
9. Please describe whether or not you found
participation in the self-directed clinical QI
project to be meaningful, impactful and a
valuable use of your time.
This was a highly valuable activity. This activity provided the format and
impetus to complete a thorough analysis on patient care activities. It provided the
avenue to analyze hundreds of patients in a manner that often does not take
place in clinical practice. Physicians often have impressions and anecdotal
evidence, but this activity furnished the mechanism to dive deeper into
understanding the impact of changes and interventions on clinical practice. While
we had believed that complication rates had improved, we still did not have the
breakdown of complications relative to systemic ?-1ARAs history. In addition, this
activity allowed us to further compare the impact of specific interventions on
complication rates.