M ILITARY M EDICINE, 179, 11:1307, 2014

Standard of Care of Erectile Dysfunction in U.S. Air Force Aircrew and Active Duty Not on Flying Status Col Justin B. Nast, USAF MC

ABSTRACT In 2011, over 3,000 active duty U.S. Air Force (USAF) members were prescribed a phosphodiesterase inhibitor (PDEI). PDEIs are first-line therapy for treating erectile dysfunction and can have significant side effects that could impact aircrew performance. In total, 200 eligible subject records were randomly sampled from the active duty USAF population of those males filling a prescription for a PDEI in June 2011; 100 of those records were from aviators. The electronic records were reviewed and scored to determine if USAF aeromedical standards for prescribing PDEIs were followed, with a minimum score of 0 for no standards met and a maximum of 3 for all standards met. The average score for both groups was 1, with no significant difference between the group scores. A proper aeromedical disposition was documented in 67% of the aviator records. Although there was no significant difference in standard of care for aviators and nonaviators, the overall documented standard of care was poor. Lack of documentation was the primary reason for the low scores and the low percentage of properly rendered aeromedical dispositions. Proper medical record documentation is important for evaluating quality of care and ensuring compliance with regulations in an Air Force aviator population.

Because of the sensitive nature of the diagnosis of ED, the INTRODUCTION The self-reported prevalence of erectile dysfunction (ED) in treating physician and patient may be reluctant to broach this the United States is estimated to be 22% and is associated subject during a routine visit. It is possible that in an attempt with a number of comorbid conditions including hyperten­ to protect the privacy of the patient, the documentation of the sion, hyperlipidemia, cardiovascular disease, and depression.1 evaluation and treatment of ED might be omitted. This study Because of these associations and the potential for ED to be a was performed to ascertain the standard of care for ED for medication side effect or a sign of male hypogonadism, a active duty USAF members as documented in the electronic careful workup for this complaint is warranted. Phosphodies­ medical record. The research hypothesis is that there is a terase type 5 inhibitors have been repeatedly shown to significant difference in the standard of care between the improve ED in randomized clinical trials and are first-line aviator and nonaviator population. This study also sought to determine if the USAF aeromedical guidelines for prescrib­ therapy for this condition.2 Phosphodiesterase inhibitors (PDEIs) pose little risk to ing PDEIs were being followed in the aviator population. individuals without preexisting coronary artery disease, and the most common side effects are headache and flushing.3 METHODS However, PDEIs can also cause transient color vision changes This research was conducted with the approval of the Air Force and photophobia and, in rare cases, may be associated with Research Laboratory Institutional Review Board (protocol sudden vision loss.4’5 Because ED can be associated with a number FWR20120189N) with a waiver of informed consent. 50-fold increase in coronary artery disease, primary care phy­ sicians should use caution when evaluating and treating a Design patient with this condition.6 When treating aviators, these issues take on even more significance when considering the This is a cross-sectional structured survey of individual per­ potential risk involved in flight operations. These risks have sonal health records to evaluate and compare the standard of been taken into account when prescribing PDEIs to U.S. Air care for the evaluation and treatment of ED. The study posed Force (USAF) aviators. Sildenafil and vardenafil, but not minimal risk to subjects, and no personally identifiable infor­ tadalafil, are approved for use, but require a verbal 24-hour mation is included in the study results. duties not including flying after each dose and are not approved for repetitive dosing (Official Air Force Approved Population and Sample Aircrew Medications, 2013; access controlled). The study population was composed of male active duty Air Force members on active flying status in calendar year 2011 who filled a prescription for Viagra, Cialis, sildenafil, Aerospace Medicine Department, U.S. Air Force School of Aerospace Levitra, Adcirca, Staxyn, or Revatio in June 2011. Subjects Medicine, 2510 5th Street, Building 840, Wright-Patterson AFB, OH 45433. This article was presented as an oral presentation at the Aerospace who were seen in a primary care clinic (family practice, flight Medical Association Meeting 2013, Chicago, IL, May 12-16, 2013. medicine, or internal medicine) were included in the study. The opinions expressed in this article are those of the author and do not There were 248 subjects on active flying status who met the necessarily reflect the opinions or official policy of the U.S. Air Force, the study criteria; of those, 100 were randomly selected for this Department of Defense, or the U.S. Government, records review. 100 randomly selected control subjects were doi: 10.7205/MILMED-D-14-00211

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Erectile Dysfunction Care in Active Duty USAF Patients chosen from a group of 2,054 male active duty Air Force members not on flying status who met the same selection criteria as the active duty members on flying status. Thus, the total number of active duty Air Force members seen in a primary care clinic who had a prescription filled for a PDEI in June 2011 was 2,302.

discussion was not documented or there was no mention of the 24-hour DNIF period, then the record was considered not to have met aeromedical standards. Only sildenafil and vardenafil are approved for aircrew use, so the PDEI pre­ scribed was also considered as part of the standard. S tu d y V a ria b le s a n d S ta tis tic a l A n a ly s is

P ro c e d u re

The electronic health record (EHR) of each subject was examined for the evaluation and treatment of ED. Medical records were evaluated using a scoring system, with 0, 1,2, or 3 points being assigned depending on how many of the three standard elements were met in the evaluation/treatment of ED from consensus guidelines created by the American Urological Association (AUA).7 These three standard elements were directly taken from the AUA guidelines. One point was assigned if the record contained a history and physical that addressed potential organic comorbidities as well as psychosexual dysfunctions that can be related to ED. Organic comorbidities included cardiovascular disease (including hypertension, atherosclerosis, or hyperlipidemia), diabetes mellitus, depression, and alcoholism. Psychosexual comor­ bidities included alterations of sexual desire and quality of relationship with partner. One point was assigned if the record documented a discussion of the risks, benefits, and treatment alternatives for ED. One point was assigned if the record documented that oral PDE-5 inhibitors were offered, unless contraindicated, as first-line therapy for ED. Zero points were assigned if the record did not document any of these elements. When the prescription for a PDEI was not associated with a specific visit; the prescribing provider and the date of the prescription were used to locate potential encounters that could contain documentation related to that prescription. When there was no associated visit or visit that documented any of the elements of the AUA guidelines, that record scored 0 points. An additional separate evaluation was made on aviator records to determine if the USAF aeromedical standards for the prescription of PDEIs were followed as outlined in the Official Air Force Aerospace Medicine Approved Medica­ tions document in effect during the study period. The most current edition of this document does not differ in respect to prescription of PDEIs (Official Air Force Approved Aircrew Medications, 2013; access controlled). Similar to the record evaluation of the AUA standards, when there was no associ­ ated visit, then documentation was sought by matching the prescribing provider and the date of the prescription with a range of visits. The record was considered to have met stan­ dards if it documented a discussion about the potential side effects of the prescribed PDEI and that the aviator was told to have duties not including flying at least 24 hours after each dose of PDEI. Documentation of the discussion of side effects was considered sufficient if the box documenting that discussion was checked in the electronic record and/or there was written documentation of such a discussion. If this

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In addition to the aggregate AUA guideline-based score and the aeromedical standards disposition, the following variables were also recorded for each record: age (calculated from date of birth and clinic visit date), PDEI prescribed (obtained from the pharmacy transaction data service and confirmed in the EHR), and whether officer or enlisted (categorized based on patient’s rank). Age of cases and controls was compared using a Student’s t test; a ;k2 test was used to compare AUA scores between groups.

RESULTS

The average age of study subjects was 43.1 (range: 25-63) for aviators and 42.6 (range: 24-63) for nonaviators; there was no statistical significance between groups in regard to age (f = 0.5, p = 0.30). Figure 1 shows that most of the scores for both aviators and nonaviators were 1, although there were more scores of 0 in the aviator category; there was no statistical difference between groups ( z 2(3) = 6.64, p - 0.084). Although there was no documentation of inappropriate pre­ scribing (tadalafil) to aviators, the documentation of a proper aeromedical disposition was present in only 67% of the avia­ tor records. If an aeromedical disposition was documented, it was correct. In other words, no documentation was largely responsible for the lack of a proper aeromedical disposition. Poor documentation was also responsible for low standard of care scores. A 0 score was representative of no documenta­ tion, and the number of records with this score for the aviator sample was more than twice that of the nonaviator sample, even though the overall scores for the two samples did not differ significantly. The scores were only recorded as an aggregate, so a separate analysis of each individual score element was not performed.

Standard o f Care Scores

40 30 20

10 0

3 FIGURE 1. Number of records with each standard of care score for aviators versus nonaviators.

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Erectile Dysfunction Care in Active Duty USAF Patients

DISCUSSION Comparing these scores between the aviators and nonaviators failed to observe a difference that the documentation of care for the treatment of ED was different between the samples. The more significant conclusion from this study is that the documentation was universally poor, including the documen­ tation of a proper aeromedical disposition in the aviator records. The significance of this finding is that it might indi­ cate poor quality of care in the treatment of ED in active duty Air Force members. Even more concerning is that only twothirds of aviator charts documented a proper aeromedical disposition when prescribing PDEIs. This has the potential to compromise aviation safety. Possible explanations for these findings include oversensitivity of clinicians to protect patient confidentiality, documentation in a form other than the EHR (paper), lack of time for proper documentation, and lack of clinical knowledge regarding the proper workup and treatment of ED, and the ability to electronically pre­ scribe without having to associate that prescription with a specific visit. Assessing quality of care using an EHR is completely dependent on documentation. The quality of this documenta­ tion can also depend on the style of documentation within the EHR.8 Additionally, the definition of what constitutes overall quality in outpatient clinical documentation has not been formally defined, although patients and clinicians appear to have differing opinions in this regard.9 This study attempted to assign a qualitative score to each record based on whether or not specific guidelines were followed within the record. The ultimate goal of the medical record is to support patient care. The record must be secure, private, and complete to accomplish this goal. Quality of care is affected by poor data in the medical record, and there are potential legal conse­ quences to poor documentation as well.10 There are several important limitations to this study. The Armed Forces Health Longitudinal Technology Application (Department of Defense EHR) was relied on as a single source document constituting the medical record. If the EHR was not available, it is possible that some of the docu­ mentation was done on paper and was not reviewed for this study. There was only a single reviewer for this study, and that can introduce potential bias in the evaluation of the record. Individuals who were prescribed a PDEI and chose to pay for it out of pocket or even ordered it online were not included because selection was based on if their pharmacy benefit was used to obtain the medication. This limitation brings up a whole other set of issues that are beyond the scope of this discussion. The only records that were selected were those that were associated with the prescription of a PDEI. If the prescription of a PDEI was not able to be associated with a visit or diagnosis that explained the reason for the prescription, then it is possible that the PDEI was being prescribed for another indication besides ED. How­ ever, this limitation does not affect the study outcome of no documentation related to the prescription. Patients who were

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treated for ED without the use of a PDEI were not included in this study. This study did not attempt to collect any specific informa­ tion about the clinicians who were prescribing the PDEI. There are potentially important differences in the clinicians in a flight medicine clinic versus a primary care clinic in the USAF. In 2011, all clinicians providing medical diagnosis and treatment in flight medicine clinics were physicians. This has changed, since the most recent edition of Air Force Instruction 48-149 allows for the use of physician assistants in flight medicine clinics, although they are prohibited from making aeromedical dispositions." In primary care clinics, there is a mix of clinicians including nurse practitioners, physician assistants, and physicians. This study did not attempt to find if there were differences in the standard of care related to treating clinician, although this is certainly an area that should be investigated to see if clinician type is a factor in documentation related to standard of care. Ulti­ mately, it will be easier to examine this issue from a quality assurance perspective than a research perspective because such quality assurance endeavors will not be burdened by requirements of an Institutional Review Board and will poten­ tially have immediate local impact. System-wide changes must still be examined using a research protocol after insti­ tuting quality measures. In conclusion, the most important finding in this study was the poor documentation related to the evaluation and treat­ ment of ED. The reasons for this finding are unclear but warrant further evaluation to determine if the reasons are related more to the user or to the system. Physician-specific variation in documentation in the EHR has been well recog­ nized, but the reasons for this variation have not been thoroughly studied.12 If the problem is related to lack of education, formal training in documentation quality that includes demonstration of self-efficacy has been shown to be effective.11 Proper documentation of patient care is a foun­ dation of professionalism that should not be compromised in the flight medicine clinic or any other clinic in a military treatment facility. ACKNOWLEDGMENTS I would like to thank Sandy Kawano for help with editing and Genny Maupin, MPH, for help with data collection.

REFERENCES 1. Rosen RC, Fisher WA, Eardley I, et al: The multinational Men’s Attitudes to Life Events and Sexuality (MALES) study: I. Prevalence of erectile dysfunction and related health concerns in the general population. Curr Med Res Opin 2004; 20: 607-17. 2. McVary KT: Clinical practice. Erectile dysfunction. N Engl J Med 2007;357:2472-81. 3. Kuthe A: Phosphodiesterase 5 inhibitors in male sexual dysfunction. Curr Opin Urol 2003; 13: 405-10. 4. Azzouni F, Abu SK: Are phosphodiesterase type 5 inhibitors associated with vision threatening adverse events? A critical analysis and review of the literature. J Sex Med 2011; 8: 2894-903.

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Erectile Dysfunction Care in Active Duty USAF Patients 5. Kerr NM, Danesh-Meyer HV: Phosphodiesterase inhibitors and the eye. Clin Experiment Ophthalmol 2009; 37: 514-23. 6. Greenspan MB, Barkin J: Erectile dysfunction and testosterone deficiency syndrome: the “portal to men’s health.” Can J Urol 2012; 19 (Suppl 1): 18-27. 7. Montague DK, Jarow JP, Broderick GA, et al: Chapter 1: The manage­ ment of erectile dysfunction: an AUA update. J Urol 2005; 174: 230-9. 8. Linder JA, Schnipper JL, Middleton B: Method of electronic health record documentation and quality of primary care. J Am Med Inform Assoc 2012; 19: 1019-24. 9. Hanson JL, Stephens MB, Pangaro LN, Gimbel RW: Quality of outpatient clinical notes: a stakeholder definition derived through qualitative research. BMC Health Serv Res 2012; 12: 407.

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10. Harman LB, Flite CA, Bond K: Electronic health records: privacy, confidentiality, and security. Virtual Mentor 2012; 14: 712-9. 11. Department of the U.S. Air Force: Air Force Instruction 48-149. Flight and Operational Medicine Program (FOMP). Washington, DC, Department of the Air Force, August 29, 2012. Available at www.e-publishing.af.mil (restricted access); accessed July 16, 2014. 12. Pollard SE, Neri PM, Wilcox AR, et al: How physicians document outpatient visit notes in an electronic health record. Int J Med Inform 2013; 82: 39-46. 13. Russo R, Fitzgerald SP, Eveland JD, Fuchs BD, Redmon DP: Improving physician clinical documentation quality: evaluating two self-efficacy-based training programs. Health Care Manage Rev 2013; 38: 29-39.

MILITARY MEDICINE, Vol. 179, N ovem ber 2014

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Standard of care of erectile dysfunction in U.S. Air Force aircrew and active duty not on flying status.

In 2011, over 3,000 active duty U.S. Air Force (USAF) members were prescribed a phosphodiesterase inhibitor (PDEI). PDEIs are first-line therapy for t...
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