Purpose
To increase the vaccination rate and identify barriers to administration of the vaccine against herpes zoster by having ophthalmologists screen and provide the vaccine.
Design
Prospective interventional cohort study.
Methods
setting : Academic City Hospital, Bellevue Hospital. participants : A total of 100 eligible patients based on recommended Centers for Disease Control (CDC) criteria and ability to speak English and Spanish who received the herpes zoster vaccine were compared with 66 patients who declined the vaccine. interventions : The vaccine was administered after written informed consent was obtained to complete a screening questionnaire evaluating the participants’ eligibility and interest in receiving the vaccine. main outcome measures : Barriers to administration of the vaccine were evaluated.
Results
A total of 170 consenting patients, including 100 patients who were vaccinated, 66 patients who declined vaccination, and 4 patients who were ineligible, were analyzed. The proportion of subjects who would consider receiving the vaccine if recommended by a doctor among those who received the shingles vaccine, 98.0% (95% CI: 95%-100%), was significantly greater than the proportion in the group that declined, 74.2% (95% CI: 64%-85%) ( P ≤ .0001). The most common reason that patients declined the vaccine was wanting to speak with their primary care physician, 46.9% (95% CI: 33%-61%).
Conclusions
Ophthalmologists can screen, educate, and prescribe the vaccine against herpes zoster in order to increase utilization of this vaccine. Nonfinancial or access barriers of this vaccine among underserved eligible patients include absence of recommendation by their primary care doctor.
Herpes zoster (HZ), or shingles, is a dermatomal infection that occurs because of reactivation of latent Varicella zoster virus (VZV) in patients who have had chicken pox. Zoster is associated with moderate to severe pain acutely and, in addition to postherpetic neuralgia, can be complicated by chronic eye disease and result in loss of vision. Ocular manifestations of herpes zoster ophthalmicus (HZO) include acute and chronic keratouveitis, neurotrophic keratopathy, secondary glaucoma, occlusive retinal vasculitis, and cranial nerve involvement. The risk for postherpetic neuralgia (PHN) increases with age, particularly for persons aged ≥50 years. In one study, approximately 80%-85% of PHN occurs in zoster patients aged ≥50 years, and PHN may become chronic in 30% of cases. The discomfort associated with herpes zoster can be prolonged and disabling, diminishing quality of life and ability to function to a degree comparable to that in diseases such as congestive heart failure, myocardial infarction, diabetes mellitus type 2, and major depression. Although more common and severe in older and immunocompromised patients, it also causes considerable morbidity in adults without underlying systemic disease.
There are approximately 1 000 000 new cases per year in the United States, and the number of cases has increased significantly from 2000 to 2007 in people older than 40 years. Lifetime risk of developing HZ is estimated to be 30%. Since the licensure and increased use of the varicella vaccine since 1995 in the United States, exposure to VZV in the community has been altered. Now adults aged <50 years who had relied on periodic exposure to VZV-infected children to mobilize their own cell-mediated immunity against the virus may experience a greater incidence of HZ in the future. However, there is also evidence reported by the Centers for Disease Control (CDC) that the increase in zoster began prior to the introduction of vaccination against chicken pox and is not necessarily correlated with extent of varicella immunization. A cost–benefit analysis performed in 2005 predicted that in adults aged <50 years, there will be an additional 14.6 million cases of HZ (a 42% increase) over the next 50 years, leading to a substantial increase in medical costs and economic burden.
The Zoster Vaccine Live vaccine (Merck & Co Inc, Whitehouse Station, New Jersey, USA) was evaluated in a large randomized clinical trial for the reduction of the frequency and severity of herpes zoster and was Federal Drug Administration (FDA) approved in May 2006 for immunocompetent patients aged 60 and above. In March 2011, the FDA extended the approval to those aged ≥50, and a postlicensure study found efficacy for preventing HZ in persons 50-59 to be 69.8%. Overall, the vaccine reduced the burden of disease by more than 61%, reduced postherpetic neuralgia by 66.5%, and reduced the incidence of zoster by 51%. Based on these results, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended in 2006 routine vaccination of all immunocompetent persons aged ≥60 years, including those with a history of HZ or chronic medical conditions. These recommendations were published in June 2008 and remain unchanged. Nonetheless, according to the CDC, as of 2010 only 14.4% of eligible people in the United States have received this vaccine. The top reported barriers to vaccination in general practice are cost to patients, storage requirements, and lack of strong physician recommendation.
Ophthalmologists treat acute and chronic manifestations of HZO, which accounts for 10%-20% of all cases of zoster. Among ophthalmologists, there is knowledge of the chronic and recurrent nature of HZO, and knowledge that healthy patients beginning in their forties are at increased risk for this potentially blinding and disabling condition. In an attempt to increase vaccine usage according to current national recommendations, ophthalmologists can educate patients about HZ and the vaccine against it, as well as prescribe the vaccine to eligible patients.
The purpose of this study is to have ophthalmologists promote recommended zoster vaccination usage in an urban, underserved population. We hypothesize that by having ophthalmologists administer the vaccine against zoster at no cost to the patient in the eye clinic, thereby eliminating barriers such as access (administering a vaccine at a hospital that does not have it on formulary) and cost (by offering it free of charge to eligible patients in the eye clinic at the time of their scheduled appointment), we will be able to increase the use of the vaccine and identify other potential barriers that prevent usage of the vaccination for herpes zoster in this underserved population.
Methods
This was a prospective interventional cohort study approved by the New York University Institutional Review Board (IRB) and Bellevue Research Committee for this Health Insurance Portability and Accountability Act–compliant study, and all research material including study questionnaires and informed consents were IRB approved and adhered to the tenets of the Declaration of Helsinki. Patients gave written informed consent for screening for medical eligibility for the vaccine because this involved personal health information. After screening, eligible patients were encouraged to obtain the vaccine, but consent was not necessary to receive information, education, or vaccination as it was used in accordance with current national recommendations by the CDC. We prospectively recruited ophthalmology patients who presented to the Bellevue Eye Clinic, which is an outpatient eye clinic in a New York City hospital, beginning January 9, 2012. Patients were screened daily until 100 eligible patients were prescribed and received the vaccine. Inclusion criteria included patients who were aged 60 years and above and able to speak and read English or Spanish. Exclusion criteria were based on the CDC recommendations as referenced in Table 1 , including immunocompromised state.
| Recommendations |
| Adults 60 years old or older, whether or not the patient reported a prior episode of shingles |
| Persons with chronic medical conditions may be vaccinated unless a contraindication or precaution exists for their condition |
| Persons reporting a negative history of varicella |
| Contraindications |
| History of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine |
| History of primary or acquired immunodeficiency state, including leukemia, lymphoma, or other malignant neoplasm affecting the bone marrow or lymphatic system |
| History of acquired immunodeficiency syndrome, cluster of differentiation 4 (CD4) count ≤200, or other clinical manifestation of infection with human immunodeficiency virus |
| High-dose corticosteroid immunosuppressive therapy or prednisone 20 mg daily for 2 or more weeks |
| Immunomodulatory therapy with recombinant immune mediators and anti–tumor necrosis factor medications |
| Chemotherapy utilizing more than low-dose methotrexate, azothiaprine, or 6-mercaptopurine for inflammatory diseases |
| Persons who are or may be pregnant |
Patients’ medical records were prescreened by ophthalmology residents to determine eligibility based on the inclusion and exclusion criteria. Potentially eligible patients who presented for their eye clinic appointment were asked to give written informed consent to participate in this prospective study and for access to their personal health information. All patients were counseled and encouraged to obtain the vaccination by the study investigators, including medical students, the project manager, ophthalmology residents, and the ophthalmologist primary investigator. Participants then completed a standardized questionnaire administered by the research team in a confidential setting. The screening questionnaire included questions regarding demographic information such as age, sex, race/ethnicity, level of education, insurance status, access to a primary care physician, awareness of herpes zoster, history of prior vaccinations, and medical history of contraindications. Each eligible patient was then offered the vaccination and if interested, was administered the vaccine free of charge in the eye clinic by a registered nurse before or after their appointment. Patients who were eligible and declined the vaccination were asked for their reasons why and this information was recorded.
We telephoned each patient 1 month following the vaccination to assess adverse events, including up to 5 repeat calls for unreachable patients. A 2- to 3-month follow-up visit at the eye clinic with 3 letter reminders to those not reached by phone was scheduled to adminster a brief postvaccination survey about possible adverse events. The participant was compensated $20 to cover travel expenses for the follow-up visit.
Statistical Methods
The results of our interventional program to provide shingles vaccination were summarized using descriptive statistics such as means, standard deviations, medians, ranges, continuous variables, and frequency distributions for qualitative variables such as characteristics of the population screened and reasons for ineligibility. Demographic characteristics and responses to the survey questions were compared for subjects who agreed to vaccination and those who declined the vaccination using inferential statistics that included confidence intervals and statistical tests. Fisher exact tests were used to compare the distributions of qualitative responses to each question for these 2 groups and Wilcoxon rank sum nonparametric tests were used for quantitative responses. No statistical adjustments for multiple questions were applied. Based on the observed proportions of the results for the groups of patients who received or declined the vaccine, differences greater than ±0.22 were detectable with power of 80% and 2-sided alpha of 0.05.
Statistical analyses were performed using SAS 9.3 software (SAS Institute Inc, Cary, North Carolina, USA).
Results
The Bellevue Hospital medical records of 2101 patients with appointments were prescreened by the ophthalmology residents at Bellevue Eye Clinic from January 9, 2011 to February 27, 2012, of which 1290 (1290/2101, 61.4%) were excluded because of age less than 60 and 37 (37/811, 4.6%) because of medical contraindications based on CDC recommendations ( Table 1 ). Seven hundred seventy-four patients were eligible based on the CDC zoster vaccine criteria and age. Of this prescreened cohort, 290 presented to the clinic for their ophthalmology appointment and were evaluated for participation in the study ( Table 2 ). One hundred twenty patients were eligible but did not participate in the study; reasons for nonparticipation are shown in Table 2 . One hundred seventy patients agreed to participate in the study and received a questionnaire on 30 clinic days at Bellevue Eye Clinic. Of these 170 patients, 100 received the vaccine, 66 declined the vaccine, and 4 were ineligible. The 4 consented (4/170, 2.4%) ineligible patients included 2 (1.2%) with contraindications such as history of lymphoma and use of mofotil and 2 (1.2%) who had already received the vaccine against zoster ( Table 3 ). These patients were excluded from further data analysis.
| Subject Group | Number (%) |
|---|---|
| Prescreened patients (n = 2101 patients) | |
| Excluded because of age (≤60 years) | 1290/2101 (61.4%) |
| Included after screening for age (>60 years) | 811/2101 (38.6%) |
| Excluded because of vaccine contraindications (n = 811 patients) | 37/811 (4.6%) |
| Specific exclusion reason because of vaccine contraindications (n = 37 excluded patients) | |
| 6/37 (16.2%) |
| 2/37 (5.4%) |
| 0/37 (0.0%) |
| 8/37 (21.6%) |
| 13/37 (35.1%) |
| 8/37 (21.6%) |
| 0/37 (0.0%) |
| 0/37 (0.0%) |
| Eligible patients that kept their appointment (n = 774) | 290/774 (37.5%) |
| Excluded for refusal to participate in 290 patients who kept appointments | 120/290 (41.4%) |
| Specific exclusion reason because of refusal to participate (n = 120) | |
| 50/120 (41.2%) |
| 23/120 (19.2%) |
| 16/120 (13.3%) |
| 4/120 (3.3%) |
| 27/120 (22.5%) |
| Variables | Total (%) | Received Vaccine | Declined Vaccine | P Value a |
|---|---|---|---|---|
| Participants, n (%) | 166 (100.0%) | 100 (100.0%) | 66 (100.0%) | |
| Age, median (range) | 68 (60-94) | 67 (60-88) | 68.5 (60-94) | .89 |
| Sex, n (%) | .153 | |||
| Male | 72 (43.4%) | 48 (48.0%) | 24 (36.4%) | |
| Female | 94 (56.6%) | 52 (52.0%) | 42 (63.6%) | |
| Race, n (%) | .489 | |||
| Non-Hispanic white | 29 (17.5%) | 16 (16.0%) | 13 (19.7%) | |
| Non-Hispanic black | 35 (21.1%) | 21 (21.0%) | 14 (21.2%) | |
| Hispanic | 86 (51.8%) | 50 (50.0%) | 36 (54.6%) | |
| Asian | 8 (4.8%) | 6 (6.0%) | 2 (3.0%) | |
| Other | 8 (4.8%) | 7 (7.0%) | 1 (1.6%) | |
| Primary language, n (%) | .728 | |||
| English | 68 (41.2%) | 43 (43.0%) | 25 (38.5%) | |
| Spanish | 83 (50.3%) | 47 (47.0%) | 36 (55.4%) | |
| Chinese | 3 (1.8%) | 2 (2.0%) | 1 (1.5%) | |
| Other | 11 (6.7%) | 8 (8.0%) | 3 (4.6%) | |
| Education, n (%) | .797 | |||
| < high school graduate | 65 (39.2%) | 38 (38.0%) | 27 (40.9%) | |
| high school graduate | 48 (28.9%) | 28 (28.0%) | 20 (30.3%) | |
| > high school graduate | 53 (31.9%) | 34 (34.0%) | 19 (28.8%) | |
| Insurance status, n (%) | .02 | |||
| Yes | 130 (78.3%) | 72 (72.0%) | 58 (87.9%) | |
| No | 36 (21.7%) | 28 (28.0%) | 8 (12.1%) | |
| Insurance type, n (%) | .542 | |||
| Employer or union | 5 (3.9%) | 3 (3.9%) | 2 (3.5%) | |
| Medicare | 36 (27.7%) | 23 (31.9%) | 13 (22.4%) | |
| Medicaid | 42 (32.3%) | 21 (29.2%) | 21 (36.2%) | |
| Both Medicaid/Medicare | 45 (34.6%) | 23 (31.9%) | 22 (37.9%) |
a P values (2-sided) for comparison between groups that received or declined vaccine. Analysis was based on Fisher exact test for qualitative values and on Wilcoxon rank sum test for quantitative values. (Bolded P values are those ≤.05.)
Table 3 summarizes demographic characteristics for patients who received and declined vaccination. The distributions of age, sex, race, primary language, and education did not significantly differ between the 2 groups, indicating that we were equally successful in the administration of the herpes zoster vaccine among all of our patients regardless of age, sex, race, language, or level of education ( Table 3 , P > .05). The only significant difference between the 2 groups was that patients who accepted the vaccine were less likely to have insurance, with 72% for the vaccinated group vs 87.9% for the declined group ( P < .05).
Table 4 summarizes the responses to the questionnaire. The proportions of subjects who had heard of shingles vaccine, had ever had shingles, knew someone who had shingles, and had a regular doctor were not significantly different between the vaccinated group and the group that declined vaccination ( Table 4 ). Among the 100 patients who consented and received the vaccine, 60% (95% CI: 49.7%-69.7%) had heard of the shingles; 9.0% (95% CI: 3.4%-14.6%) had shingles previously; 41% (95% CI: 31.4%-50.6%) knew of someone who had shingles; 8% (95% CI: 2.7%-13.3%) had heard of the vaccine against shingles; and 94% (95% CI: 89.3%-98.7%) had a regular doctor. Among the 66 patients who consented and declined the vaccine, 63.6% (95% CI: 50.9%-75.1%) had heard of shingles; 6.1% (95% CI: 0.3%-11.9%) had shingles previously; 39.4% (95% CI: 27.6%-51.2%) knew of someone who had shingles; and 7.6% (95% CI: 1.2%-14.0%) had heard of the vaccine against shingles, indicating that the awareness of shingles or the vaccine was not a factor in our patients’ decision to accept or decline the vaccine.
| Questions | Eligible Patients (N = 166) | Received Vaccine (N = 100) | Declined Vaccine (N = 66) | P Value a |
|---|---|---|---|---|
| Have ever heard of shingles | 102 (61.5%) | 60 (60.0%; 95% CI: 49.7%-69.7%) | 42 (63.6%; 95% CI: 50.9%-75.1%) | .745 |
| Have ever had shingles | 13 (7.8%) | 9 (9.0%; 95% CI: 3.4%-14.6%) | 4 (6.1%; 95% CI: 0.3%-11.9%) | .567 |
| Know someone who had shingles | 67 (40.4%) | 41 (41.0%; 95% CI: 31.4%-50.6%) | 26 (39.4%; 95% CI: 27.6%-51.2%) | .873 |
| Have ever heard of shingles vaccine | 13 (7.8%) | 8 (8.0%; 95% CI: 2.7%-13.3%) | 5 (7.6%; 95% CI: 1.2%-14.0%) | >.999 |
| Have a regular doctor | 156 (94.0%) | 94 (94.0%; 95% CI: 89.3%-98.7%) | 62 (93.9%; 95% CI: 88.1%-99.7%) | >.999 |
a P values (2-sided) for comparison between groups that received or declined vaccine.
Moreover, the proportion of subjects who received a flu vaccine in the prior year among those who received the shingles vaccine (89.0%; 95% CI: 83%-95%) was greater ( P = .007) than the proportion in the group that declined the vaccine (71.2%; 95% CI: 60%-82%). The proportion of subjects over age of 65 who received the pneumovax vaccine among the vaccinated group (62.3%; 95% CI: 51%-74%) was not significantly different from the declined group (72.5%; 95% CI: 59%-86%) ( P = .30).
The proportion of subjects who would consider receiving the vaccine if recommended by a doctor among those who received the shingles vaccine (98.0%; 95% CI: 95%-100%) was greater ( P ≤ .0001) than the proportion in the group that declined the vaccine (74.2%; 95% CI: 64%-85%).
Of the 66 patients who declined the vaccine, 49 answered the questions about the reasons for decline. As shown in Table 5, 46.9% of them wanted to speak with their primary doctor, indicating that the recommendation of their primary doctor regarding the vaccination against zoster remained of paramount importance. Less frequent responses included concerns about side effects and fear of needles ( Table 5 ).
