Prospective Evaluation of Coronavirus Disease 2019 (COVID-19) Vaccine Responses Across a Broad Spectrum of Immunocompromising Conditions: the COVID-19 Vaccination in the Immunocompromised Study (COVICS).

BACKGROUND: We studied humoral responses after coronavirus disease 2019 (COVID-19) vaccination across varying causes of immunodeficiency. METHODS: Prospective study of fully vaccinated immunocompromised adults (solid organ transplant [SOT], hematologic malignancy, solid cancers, autoimmune conditions, human immunodeficiency virus [HIV]) versus nonimmunocompromised healthcare workers (HCWs). The primary outcome was the proportion with a reactive test (seropositive) for immunoglobulin G to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) receptor-binding domain. Secondary outcomes were comparisons of antibody levels and their correlation with pseudovirus neutralization titers. Stepwise logistic regression was used to identify factors associated with seropositivity. RESULTS: A total of 1271 participants enrolled: 1099 immunocompromised and 172 HCW. Compared with HCW (92.4% seropositive), seropositivity was lower among participants with SOT (30.7%), hematological malignancies (50.0%), autoimmune conditions (79.1%), solid tumors (78.7%), and HIV (79.8%) (P < .01). Factors associated with poor seropositivity included age, greater immunosuppression, time since vaccination, anti-CD20 monoclonal antibodies, and vaccination with BNT162b2 (Pfizer) or adenovirus vector vaccines versus messenger RNA (mRNA)-1273 (Moderna). mRNA-1273 was associated with higher antibody levels than BNT162b2 or adenovirus vector vaccines after adjusting for time since vaccination, age, and underlying condition. Antibody levels were strongly correlated with pseudovirus neutralization titers (Spearman r = 0.89, P < .0001), but in seropositive participants with intermediate antibody levels, neutralization titers were significantly lower in immunocompromised individuals versus HCW. CONCLUSIONS: Antibody responses to COVID-19 vaccines were lowest among SOT and anti-CD20 monoclonal recipients, and recipients of vaccines other than mRNA-1273. Among those with intermediate antibody levels, pseudovirus neutralization titers were lower in immunocompromised patients than HCWs. Additional SARS-CoV-2 preventive approaches are needed for immunocompromised persons, which may need to be tailored to the cause of immunodeficiency.

Resident and Attending Physicians' Perceptions of Patient Access to Provider Notes: Comparison of Perceptions Prior to Pilot Implementation.

BACKGROUND: As electronic health records have become a more integral part of a physician's daily life, new electronic health record tools will continue to be rolled out to trainees. Patient access to provider notes is becoming a more widespread practice because this has been shown to increase patient empowerment. OBJECTIVE: In this analysis, we compared differences between resident and attending physicians' perceptions prior to implementation of patient access to provider notes to facilitate optimal use of electronic health record features and as a potential for patient empowerment. METHODS: This was a single-site study within an academic internal medicine program. Prior to implementation of patient access to provider notes, we surveyed resident and attending physicians to assess differences in perceptions of this new electronic health record tool using an open access survey provided by OpenNotes. RESULTS: We surveyed 37% (20/54 total) of resident physicians and obtained a 100% response rate and 72% (31/44 total) of attending physicians. Similarities between the groups included concerns about documenting sensitive topics and anticipation of improved patient engagement. Compared with attending physicians, resident physicians were more concerned about litigation, discussing weight, offending patients, and communicated less overall with patients through electronic health record. CONCLUSIONS: Patient access to provider notes has the potential to empower patients but concerns of the resident physicians need to be validated and addressed prior to its utilization.

Direct Release of Test Results to Patients Increases Patient Engagement and Utilization of Care.

An important focus for meaningful use criteria is to engage patients in their care by allowing them online access to their health information, including test results. There has been little evaluation of such initiatives. Using a mixed methods analysis of electronic health record data, surveys, and qualitative interviews, we examined the impact of allowing patients to view their test results via patient portal in one large health system. Quantitative data were collected for new users and all users of the patient portal. Qualitative interviews occurred with patients who had received an HbA1c or abnormal Pap result. Survey participants were active patient portal users. Our main measures were patient portal usage, factors associated with viewing test results and utilizing care, and patient and provider experiences with patient portal and direct release. Usage data show 80% of all patient portal users viewed test results during the year. Of survey respondents, 82.7% noted test results to be a very useful feature and 70% agreed that patient portal has made their provider more accessible to them. Interviewed patients reported feeling they should have direct access to test results and identified the ability to monitor results over time and prepare prior to communicating with a provider as benefits. In interviews, both patients and physicians reported instances of test results leading to unnecessary patient anxiety. Both groups noted the benefits of results released with provider interpretation. Quantitative data showed patient utilization to increase with viewing test results online, but this effect is mitigated when results are manually released by physicians. Our findings demonstrate that patient portal access to test results was highly valued by patients and appeared to increase patient engagement. However, it may lead to patient anxiety and increase rates of patient visits. We discuss how such unintended consequences can be addressed and larger implications for meaningful use criteria.

Same-day intrauterine device placement is rarely complicated by pelvic infection.

PURPOSE: To compare rates of pelvic inflammatory disease (PID) among women who did and did not receive an intrauterine device (IUD) the day they sought emergency contraception (EC) or pregnancy testing. METHODS: Women, 15 to 45 years of age, who sought EC or pregnancy testing from an urban family planning clinic completed surveys at the time of their clinic visit (August 22, 2011, to May 30, 2013) and 3 months after their clinic visit. The surveys assessed contraceptive use and symptoms, testing, and treatment for sexually transmitted infections (STI) and PID. We reviewed the medical records of participants who reported IUD placement within 3 months of enrollment and abstracted de-identified electronic medical record (EMR) data on all women who sought EC or pregnancy testing from the study clinic during the study period. FINDINGS: During the study period, 1,060 women visited the study clinic; 272 completed both enrollment and follow-up surveys. Among survey completers with same-day IUD placement, PID in the 3 months after enrollment was not more common (1/28 [3.6%]; 95% CI, 0%-10.4%) than among women who did not have a same-day IUD placed (11/225 [4.9%]; 95% CI, 2.7%-8.6%; p = .71). Chart review and EMR data similarly showed that rates of PID within 3 months of seeking EC or pregnancy testing were low whether women opted for same-day or delayed IUD placement. CONCLUSIONS: Same-day IUD placement was not associated with higher rates of PID. Concern for asymptomatic STI should not delay IUD placement, and efforts to increase the uptake of this highly effective reversible contraception should not be limited to populations at low risk of STI.

A checklist approach to caring for women seeking pregnancy testing: effects on contraceptive knowledge and use.

OBJECTIVE: To assess how a checklist reminding clinicians to deliver a bundled intervention affects contraceptive knowledge and use 3 months after women seek walk-in pregnancy testing. METHODS: Pre-intervention, an inner-city family planning clinic provided unstructured care; during the intervention period, clinic staff used a checklist to ensure women received needed services. Women seeking walk-in pregnancy testing who wished to avoid pregnancy for at least 6 months were asked to complete surveys about their contraceptive knowledge and use immediately after and 3-months after visiting the study clinic. To assess the significance of changes over time, we used logistic regression models. RESULTS: Between January 2011 and May 2013, over 1500 women sought pregnancy testing from the study clinic; 323 completed surveys (95 pre-intervention and 228 during the intervention period). With this checklist intervention, participants were more likely to receive emergency contraception (EC) (22% vs. 5%, [aOR 4.66 (1.76-12.35)], [corrected] have an intrauterine device or implant placed at the time of their clinic visit (5% vs. 0%, p=0.02), or receive a contraceptive prescription (23% vs. 10%, p<0.001). Three months after visiting the study clinic, participants from the intervention period were more knowledgeable about intrauterine and subdermal contraception and were more likely to report at 3-month follow-up a method of contraception more effective than the method they used prior to seeking pregnancy testing from the study clinic (aOR=2.02, 95% CI=1.03-3.96). The authors would like to apologize for any inconvenience caused. [corrected]. CONCLUSIONS: Women seeking walk-in pregnancy testing appear more likely to receive EC and to have switched to a more effective form of birth control in the 3 months following their visit when clinic staff used a 3-item checklist and provided scripted counseling. IMPLICATIONS: A checklist reminding clinic staff to assess pregnancy intentions, provide scripted counseling about both emergency and highly-effective reversible contraception, and offer same-day contraceptive initiation to women seeking walk-in pregnancy testing appears to increase use of more effective contraception.

Routine counseling about intrauterine contraception for women seeking emergency contraception.

OBJECTIVE: To compare contraceptive knowledge and use among women seeking emergency contraception (EC) before and after an inner-city clinic began providing structured counseling and offering same-day intrauterine device (IUD) or implant placement to all women seeking EC. STUDY DESIGN: For 8 months before and 21 months after this change in clinic policy, women aged 15-45 who wanted to avoid pregnancy for at least 6 months were asked to complete surveys immediately, 3 and 12 months after their clinic visit. In addition, we abstracted electronic medical record (EMR) data on all women who sought EC (n=328) during this period. We used chi-squared tests to assess pre/post differences in survey and EMR data. RESULTS: Surveys were completed by 186 women. After the clinic began offering structured counseling, more women had accurate knowledge of the effectiveness of IUDs, immediately and 3 months after their clinic visit. In addition, more women initiated IUD or implant use (survey: 40% vs. 17% preintervention, p=0.04; EMR: 22% vs. 10% preintervention, p=0.01), and fewer had no contraceptive use (survey: 3% vs. 17% preintervention, p<0.01; EMR: 32% vs. 68%, p<0.01) in the 3 months after seeking EC. EMR data indicate that when same-day placement was offered, 11.0% of women received a same-day IUD. Of those who received a same-day IUD, 88% (23/26) reported IUD use at 3-months and 80% (12/15) at 12 months. CONCLUSIONS: Routine provision of structured counseling with the offer of same-day IUD placement increases knowledge and use of IUDs 3 months after women seek EC. IMPLICATIONS: Women seeking EC from family planning clinics should be offered counseling about highly effective reversible contraceptives with the option of same-day contraceptive placement.

Asking for what she needs? Pregnancy testing or EC?

BACKGROUND: When used within 5 days of unprotected sex, emergency contraception (EC) can reduce the risk of pregnancy. Our objective was to explore how often women seeking clinic-based pregnancy testing who do not desire pregnancy might benefit from EC and examine variables associated with patients asking for EC when use is indicated. STUDY DESIGN: Women seeking pregnancy testing or EC from an inner-city Title-X-funded family planning clinic between January 2011 and June 2012 were invited to complete surveys. RESULTS: Twenty-seven percent (n=79) of respondents were seeking EC, and 73% (n=215) were seeking pregnancy testing. Of those seeking pregnancy testing, 39% might have benefited from same-day use of EC pills. Women who had never used EC and who had more than one episode of unprotected sex within the past month were less likely to request EC when use was indicated, while single women were more likely to request EC. CONCLUSIONS: Counseling regarding EC options is particularly important for women seeking same-day pregnancy testing who do not desire pregnancy.

Insight into the treatment of vulvar pain: a survey of clinicians.

OBJECTIVE: The purpose of this investigation was to determine practice patterns among clinicians who frequently treat patients with vulvar pain syndromes. STUDY DESIGN: A cross-sectional survey was distributed to providers in the United States whose names were on a referral list of clinicians that care for women with vulvar pain (National Vulvodynia Association, Silver Springs, MD). The survey included 2 clinical vignettes. Clinicians were asked to report what treatments they would use to treat women with generalized vulvodynia and localized vulvodynia. Data were analyzed with descriptive statistics. A comparison of categoric data was accomplished with the Fisher's exact test. RESULTS: Surveys were mailed to 327 providers; 167 completed surveys were returned, for an overall response rate of 51%. The most commonly used treatment for vulvodynia was tricyclic antidepressants. There was no difference in the use of physical therapy, estrogens, injected or topical steroids, interferon, or laser therapy to treat generalized and localized vulvodynia. Respondents were more likely to use tricyclic antidepressants (P < .001), gabapentin (P < .001), and psychiatric care (P < .001) and less likely to use local anesthesia (P < .001) and vestibulectomy (P = .007) for the clinical scenario that represented generalized vulvodynia than they were for the scenario that represented localized vulvodynia. Most clinicians reported screening for vaginal infections, and many clinicians perform colposcopy and/or vulvar biopsy. Respondents recommend a variety of lifestyle modifications in the treatment of vulvodynia. CONCLUSION: Clinicians use a wide variety of treatments for vulvar pain and use different therapies for variants of vulvodynia.

Pre-emptive analgesia in gynecologic surgical procedures: preoperative wound infiltration with ropivacaine in patients who undergo laparotomy through a midline vertical incision.

OBJECTIVE: We tested the hypothesis that local anesthetic that is injected before a vertical midline abdominal incision would decrease the use of postoperative opioids. STUDY DESIGN: Patients who would undergo abdominal surgical procedures with general anesthesia by a planned vertical midline incision were enrolled in the study. Patients were assigned randomly to receive either 0.5% ropivacaine or normal saline solution placebo that was injected in the subcuticular tissue and fascia before the incision of each. All patients received morphine after the operation with a patient-controlled analgesia device. Morphine consumption was measured during the postoperative period at intervals of 0 to 6 hours, 6 to 12 hours, 12 to 24 hours, and 24 to 48 hours. Postoperative pain was assessed at 6, 12, 24, and 48 hours after the conclusion of the procedure with a visual analog scale. RESULTS: Eighty-four patients were enrolled in the study; 16 patients were excluded; therefore, 68 patients had useable data. The two treatment groups did not differ in age, height, weight, the length of the operation, the length of the incision, the position of the incision, the placement of drains, or the procedure that was performed. There was no significant difference in morphine consumption for any of the four intervals. The visual analog scale was not significantly different between the two groups at 6, 12, or 24 hours after operation. The visual analog scale at 48 hours was lower in the group that received ropivacaine (2.69 vs 4.26, P =.02). Data were analyzed by the Student t test. CONCLUSION: Pre-emptive analgesia with 0.5% ropivacaine given before skin incision does not decrease the postoperative analgesic use in patients who undergo laparotomy by a midline vertical skin incision.