Sarah L. Goff

Postmarketing experience with topiramate and cognition

Summary: Ideal antiepileptic drugs (AEDs) are designed to stop seizures with limited central nervous system (CNS) side effects. However, CNS‐related treatment‐emergent adverse events (TEAEs) often occur in patients receiving AEDs. Topiramate (TPM) is an AED proven to be safe and effective as adjunctive treatment for epilepsy patients with partial seizures. Double‐blind, placebo‐controlled, multicenter trials demonstrated potential effects on cognition. The P.A.D.S. (post‐marketing antiepileptic drug survey) group, a cooperative group of 14 epilepsy centers that collaborate on obtaining data about new AEDs and devices, prospectively collected standardized data forms before and during treatment with TPM for epilepsy, and analyzed the postmarketing experience of CNS TEAEs with TPM. Our results from 701 treated patients show that cognitive complaints were the most common reason to discontinue TPM. The presence of complaints did have predictive value if the patient would discontinue TPM, although was not specific as to when discontinuation would occur. The spectrum of complaints in our open‐label prospective multicenter postmarketing study was similar to those observed in controlled clinical trials. We were unable to demonstrate a specific population, dose titration, or concomitant AED that was at risk to discontinue treatment.  We conclude that most patients treated with TPM will continue therapy beyond 6 months. Cognitive complaints and not efficacy reflect the primary reason for discontinuing therapy. Psychomotor slowing was the most common complaint, yet most patients elect to continue treatment, with “better” or “much better” ratings of both seizure and global improvement during treatment.

Patients’ Beliefs and Preferences Regarding Doctors’ Medication Recommendations

BackgroundAn estimated 20–50% of patients do not take medications as recommended. Accepting a doctor’s recommendation is the first step in medication adherence, yet little is known about patients’ beliefs and preferences about how medications are prescribed.ObjectiveTo explore patients’ beliefs and preferences about medication prescribing to understand factors that might affect medication adherence.MethodsFifty members from 2 health plans in Massachusetts participated in in-depth telephone interviews. Participants listened to an audio-vignette of a doctor prescribing a medication to a patient and were asked a series of questions related to the vignette. Responses were reviewed in an iterative process to identify themes related to participants’ beliefs and preferences about medication prescribing.ResultsParticipants’ beliefs and preferences about medication prescribing encompassed 3 major areas: patient–doctor relationships, outside influences, and professional expertise. Important findings included participants’ concerns about the pharmaceutical industry’s influence on doctors’ prescribing practices and beliefs that there is a clear “best” medication for most health problems.ConclusionsPatients’ beliefs and preferences about medication prescribing may affect medication adherence. Additional empiric studies that explore whether doctors’ relationships with pharmaceutical representatives impact medication adherence by affecting trust are indicated. In addition, it would be worthwhile to explore whether discussions between patients and doctors regarding equipoise (no clear scientific evidence for 1 treatment choice over another) affect medication adherence.

Validity of Using ICD-9-CM Codes to Identify Selected Categories of Obstetric Complications, Procedures and Co-morbidities

BACKGROUND The ability to measure and track changes in risk-adjusted obstetric complication rates using administrative data underpins efforts to improve obstetric quality of care, but the validity of this approach has not been adequately evaluated. We sought to assess the validity of using composites of ICD-9-CM codes to identify selected categories obstetric complications and risk factors associated with complications. METHODS Patients with ICD-9-CM codes for obstetric trauma/laceration, infection, haemorrhage, episiotomy or obesity discharged between January 2009 and March 2010 were identified in the study hospitals administrative data. One hundred medical records with ICD-9-CM codes of interest were randomly selected for review from each of the five categories. An additional 60 medical records without the ICD-9-CM codes of interest served as controls for each category. Sensitivity and specificity for the selected categories was estimated using inverse proportional weighting to adjust for sampling based on presence of one of the ICD-9-CM codes of interest. RESULTS Weighted sensitivities ranged from 0.15 [95% CI 0.11, 0.20] for obesity to 1.00 for overall infection while specificities ranged from 0.994 [95% CI 0.987, 0.998] for obesity to 0.999 [95% CI 0.996, 1.000] for episiotomy. Obese patients were not reliably identified and it was not possible ascertain whether some diagnoses were present on admission. CONCLUSIONS For selected categories of obstetric complication diagnoses, use of composite sets of ICD-9-CM codes may be a valid method to identify patients within these complication categories.

Vaccine counseling: A content analysis of patient–physician discussions regarding human papilloma virus vaccine☆

OBJECTIVES (1) Describe content and character of patient-physician human papilloma virus (HPV) vaccine discussions; (2) explore the relationship between selected characteristics and vaccine uptake. METHODS Content analyses were conducted on 184 transcripts of audio-taped patient encounters with 11-26 year old female patients that occurred from August 2008 to March 2009 and contained mention of the HPV vaccine. Directed qualitative content analysis sought to identify key themes with a focus on elements related to communication. Quantitative content analysis included determination of associations between selected factors (e.g., physician specialty, communication variables, patient age) and vaccination rates. RESULTS Communication themes identified though qualitative content analysis demonstrated potential opportunities for improvement in vaccine communication were identified. Quantitative content analysis showed twenty-eight percent of eligible patients received HPV vaccine and on average these patients were younger (17.0 vs. 19.6 years). The youngest and oldest patients were vaccinated less frequently. CONCLUSIONS Targeting age groups with lower vaccination rates may increase overall vaccine uptake. Additional quantitative analyses of patient-physician discussions about vaccine may generate further recommendations regarding optimal communication strategies for HPV vaccine counseling.

Website Characteristics and Physician Reviews on Commercial Physician-Rating Websites

Patients are increasingly seeking information about physicians online. Nearly 60% report that online reviews are important when choosing a physician.1 Because publicly reported quality data are not reported at the physician level, patients must consult physician-rating websites to find such reviews.2 The purpose of this cross-sectional study was to describe the structure of commercial physician-rating websites and the quantity of physician reviews on these sites.

Hospital workers’ perceptions of waste: a qualitative study involving photo-elicitation

Objectives To elicit sources of waste as viewed by hospital workers. Design Qualitative study using photo-elicitation, an ethnographic technique for prompting in-depth discussion. Setting U.S. academic tertiary care hospital. Participants Physicians, nurses, pharmacists, administrative support personnel, administrators and respiratory therapists. Methods A purposive sample of personnel at an academic tertiary care hospital was invited to take up to 10 photos of waste. Participants discussed their selections using photos as prompts during in-depth interviews. Transcripts were analysed in an iterative process using grounded theory; open and axial coding was performed, followed by selective and thematic coding to develop major themes and subthemes. Results Twenty-one participants (nine women, average number of years in field=19.3) took 159 photos. Major themes included types of waste and recommendations to reduce waste. Types of waste comprised four major categories: Time, Materials, Energy and Talent. Participants emphasised time wastage (50% of photos) over other types of waste such as excess utilisation (2.5%). Energy and Talent were novel categories of waste. Recommendations to reduce waste included interventions at the micro-level (eg, individual/ward), meso-level (eg, institution) and macro-level (eg, payor/public policy). Conclusions The waste hospital workers identified differed from previously described waste both in the types of waste described and the emphasis placed on wasted time. The findings of this study represent a possible need for education of hospital workers about known types of waste, an opportunity to assess the impact of novel types of waste described and an opportunity to intervene to reduce the waste identified.

Cluster randomized trials to study the comparative effectiveness of therapeutics: stakeholders' concerns and recommendations.

To describe the concerns raised by health plan members, providers and purchasers related to studying the comparative effectiveness of therapeutics using cluster randomized trials (CRTs) within health plans. An additional goal was to develop recommendations for increasing acceptability.

Patterns of obstetric infection rates in a large sample of US hospitals.

OBJECTIVE Maternal infection is a common complication of childbirth, yet little is known about the extent to which infection rates vary among hospitals. We estimated hospital-level risk-adjusted maternal infection rates (RAIR) in a large sample of US hospitals and explored associations between RAIR and select hospital features. STUDY DESIGN This retrospective cohort study included hospitals in the Perspective database with >100 deliveries over 2 years. Using a composite measure of infection, we estimated and compared RAIR across hospitals using hierarchical generalized linear models. We then estimated the amount of variation in RAIR attributable to hospital features. RESULTS Of the 1,001,189 deliveries at 355 hospitals, 4.1% were complicated by infection. Patients aged 15-19 years were 50% more likely to experience infection than those aged 25-29 years. Rupture of membranes >24 hours (odds ratio [OR], 3.0; 95% confidence interval [CI], 3.24-3.5), unengaged fetal head (OR, 3.11; 95% CI, 2.97-3.27), and blood loss anemia (OR, 2.42; 95% CI, 2.34-2.49) had the highest OR among comorbidities commonly found in patients with infection. RAIR ranged from 1.0-14.4% (median, 4.0%; interquartile range, 2.8-5.7%). Hospital features such as geographic region, teaching status, urban setting, and higher number of obstetric beds were associated with higher infection rates, accounting for 14.8% of the variation observed. CONCLUSION Obstetric RAIR vary among hospitals, suggesting an opportunity to improve obstetric quality of care. Hospital features such as region, number of obstetric beds, and teaching status account for only a small portion of the observed variation in infection rates.

Do-Not-Hospitalize Orders for Individuals with Advanced Dementia:: Healthcare Proxies' Perspectives

To determine how well healthcare proxies (HCPs) understand do‐not‐hospitalize (DNH) orders and why they may or may not initiate them.

Improving Rates of Influenza Vaccination Through Electronic Health Record Portal Messages, Interactive Voice Recognition Calls and Patient-Enabled Electronic Health Record Updates: Protocol for a Randomized Controlled Trial

Background Clinical decision support (CDS), including computerized reminders for providers and patients, can improve health outcomes. CDS promoting influenza vaccination, delivered directly to patients via an electronic health record (EHR) patient portal and interactive voice recognition (IVR) calls, offers an innovative approach to improving patient care. Objective To test the effectiveness of an EHR patient portal and IVR outreach to improve rates of influenza vaccination in a large multispecialty group practice in central Massachusetts. Methods We describe a nonblinded, randomized controlled trial of EHR patient portal messages and IVR calls designed to promote influenza vaccination. In our preparatory phase, we conducted qualitative interviews with patients, providers, and staff to inform development of EHR portal messages with embedded questionnaires and IVR call scripts. We also provided practice-wide education on influenza vaccines to all physicians and staff members, including information on existing vaccine-specific EHR CDS. Outreach will target adult patients who remain unvaccinated for more than 2 months after the start of the influenza season. Using computer-generated randomization and a factorial design, we will assign 20,000 patients who are active users of electronic patient portals to one of the 4 study arms: (1) receipt of a portal message promoting influenza vaccines and offering online appointment scheduling; (2) receipt of an IVR call with similar content but without appointment facilitation; (3) both (1) and (2); or (4) neither (1) nor (2) (usual care). We will randomize patients without electronic portals (10,000 patients) to (1) receipt of IVR call or (2) usual care. Both portal messages and IVR calls promote influenza vaccine completion. Our primary outcome is percentage of eligible patients with influenza vaccines administered at our group practice during the 2014-15 influenza season. Both outreach methods also solicit patient self-report on influenza vaccinations completed outside the clinic or on barriers to influenza vaccination. Self-reported data from both outreach modes will be uploaded into the EHR to increase accuracy of existing provider-directed EHR CDS (vaccine alerts). Results With our proposed sample size and using a factorial design, power calculations using baseline vaccination rate estimates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided). Intention-to-treat unadjusted chi-square analyses will be performed to assess the impact of portal messages, either alone or in combination with the IVR call, on influenza vaccination rates. The project was funded in January 2014. Patient enrollment for the project described here completed in December 2014. Data analysis is currently under way and first results are expected to be submitted for publication in 2016. Conclusions If successful, this study’s intervention may be adapted by other large health care organizations to increase vaccination rates among their eligible patients. ClinicalTrial ClinicalTrials.gov NCT02266277; https://clinicaltrials.gov/ct2/show/NCT02266277 (Archived by WebCite at http://www.webcitation.org/6fbLviHLH).