Marge Kurland

A Population-Based Study of the Incidence and Complication Rates of Herpes Zoster Before Zoster Vaccine Introduction

OBJECTIVE To establish accurate, up-to-date, baseline epidemiological data for herpes zoster (HZ) before the introduction of the recently licensed HZ vaccine. METHODS Using data from January 1, 1996, to October 15, 2005, we conducted a population-based study of adult residents (Greater than or equal to 22 years) of Olmsted County, MN, to determine (by medical record review) the incidence of HZ and the rate of HZ-related complications. Incidence rates were determined by age and sex and adjusted to the US population. RESULTS A total of 1669 adult residents with a confirmed diagnosis of HZ were identified between January 1, 1996, and December 31, 2001. Most (92%) of these patients were immunocompetent and 60% were women. When adjusted to the US adult population, the incidence of HZ was 3.6 per 1000 person-years (95% confidence interval, 3.4-3.7), with a temporal increase from 3.2 to 4.1 per 1000 person-years from 1996 to 2001. The incidence of HZ and the rate of HZ-associated complications increased with age, with 68% of cases occurring in those aged 50 years and older. Postherpetic neuralgia occurred in 18% of adult patients with HZ and in 33% of those aged 79 years and older. Overall, 10% of all patients with HZ experienced 1 or more nonpain complications. CONCLUSIONS Our population-based data suggest that HZ primarily affects immunocompetent adults older than 50 years; 1 in 4 experiences some type of HZ-related complication.

Herpes zoster recurrences more frequent than previously reported

OBJECTIVE To present population-based estimates of herpes zoster (HZ) recurrence rates among adults. PATIENTS AND METHODS To identify recurrent cases of HZ, we reviewed the medical records (through December 31, 2007) of all Olmsted County, Minnesota, residents aged 22 years or older who had an incident case of HZ between January 1, 1996, and December 31, 2001. Kaplan-Meier curves and Cox regression models were used to describe recurrences by age, immune status, and presence of prolonged pain at the time of the incident HZ episode. RESULTS Of the 1669 persons with a medically documented episode of HZ, 95 had 105 recurrences (8 persons with >1 recurrence) by December 31, 2007, an average follow-up of 7.3 years. The Kaplan-Meier estimate of the recurrence rate at 8 years was 6.2%. With a maximum follow-up of 12 years, the time between HZ episodes in the same person varied from 96 days to 10 years. Recurrences were significantly more likely in persons with zoster-associated pain of 30 days or longer at the initial episode (hazard ratio, 2.80; 95% confidence interval, 1.84-4.27; P<.001) and in immunocompromised individuals (hazard ratio, 2.35; 95% confidence interval, 1.35-4.08; P=.006). Women and anyone aged 50 years or older at the index episode also had a greater likelihood of recurrence. CONCLUSION Rates of HZ recurrence appear to be comparable to rates of first HZ occurrence in immunocompetent individuals, suggesting that recurrence is sufficiently common to warrant investigation of vaccine prevention in this group.

Shared decision making for patients with type 2 diabetes: a randomized trial in primary care

BackgroundPatient-centered diabetes care requires shared decision making (SDM). Decision aids promote SDM, but their efficacy in nonacademic and rural primary care clinics is unclear.MethodsWe cluster-randomized 10 practices in a concealed fashion to implement either a decision aid (DA) about starting statins or one about choosing antihyperglycemic agents. Each practice served as a control group for another practice implementing the other type of DA. From April 2011 to July 2012, 103 (DA=53) patients with type 2 diabetes participated in the trial. We used patient and clinician surveys administered after the clinical encounter to collect decisional outcomes (patient knowledge and comfort with decision making, patient and clinician satisfaction). Medical records provided data on metabolic control. Pharmacy fill profiles provided data for estimating adherence to therapy.ResultsCompared to usual care, patients receiving the DA were more likely to report discussing medications (77% vs. 45%, p<.001), were more likely to answer knowledge questions correctly (risk reduction with statins 61% vs. 33%, p=.07; knowledge about options 57% vs. 33%, p=.002) and were more engaged by their clinicians in decision making (50. vs. 28, difference 21.4 (95% CI 6.4, 36.3), p=.01). We found no significant impact on patient satisfaction, medication starts, adherence or clinical outcomes, in part due to limited statistical power.ConclusionDAs improved decisional outcomes without significant effect on clinical outcomes. DAs designed for point-of-care use with type 2 diabetes patients promoted shared decision making in nonacademic and rural primary care practices.Trial RegistrationNCT01029288

Herpes zoster vaccine effectiveness and manifestations of herpes zoster and associated pain by vaccination status

Options for managing herpes zoster (HZ)-related pain and complications have limited effectiveness, making HZ prevention through vaccination an important strategy. Limited data are available on HZ vaccine effectiveness against confirmed HZ and manifestations of HZ among vaccinated persons. We conducted a matched case-control study to assess HZ vaccine effectiveness for prevention of HZ and other HZ-related outcomes and a cohort study of persons with HZ to compare HZ-related outcomes by vaccination status. Cases were identified through active surveillance among persons age ≥60 years with HZ onset and health-care encounters during 2010-2011 in Southeastern Minnesota. Controls were age- and sex-matched to cases. Data were collected by medical record review and from participants via interviews and daily pain diaries. 266 HZ case-patients and 362 matched controls were enrolled in the vaccine effectiveness studies and 303 case-patients in the cohort study of HZ characteristics by vaccination status. Vaccination was associated with 54% (95% CI:32%-69%) reduction in HZ incidence, 58% (95% CI:31%-75%) reduction in HZ prodromal symptoms, and 70% (95% CI:33%-87%) reduction in medically-attended prodrome. HZ vaccine was statistically significant effective at preventing postherpetic neuralgia (PHN) measured at 30 d after rash onset, 61% (95% CI: 22%-80%). Among persons who developed HZ, no differences were found by vaccination status in severity or duration of HZ pain after rash onset. In this population-based study, HZ vaccination was associated with >50% reduction in HZ, HZ prodrome, and medically-attended prodrome.

Practice-based Research Network Studies and Institutional Review Boards: Two New Issues

Background: Practice-based research network (PBRN) study investigators must interface with multiple Institutional Review Boards (IRBs), many of which are unfamiliar with PBRN research. Objective: To present 2 IRB-related issues that have not appeared in the literature but occurred during the course of a large 5-year PBRN study involving 32 sites dispersed around the United States. Results: Our study required IRB approval from a total of 19 local, hospital, academic center, and professional organization-based IRBs that reviewed a protocol of postpartum depression screening and follow-up completed in English or Spanish. Initial approval of the protocol and consent forms proceeded with only the usual barriers of submitting 19 different forms, and no protocol amendments were required. However, 2 unanticipated IRB issues provided significant additional work for the study team and the local practice sites. First, several IRBs required staff to repeat human subjects training every 1 to 2 years, resulting in 92 practicing physicians, residents, and members of the nursing staff spending time completing the exact same human subjects’ training at least twice during the course of this study. Second, 17 of the 19 IRBs required that the patient be given consent forms that were newly stamped and dated each year, requiring the central site to reprint and replace consent forms yearly. Because not all IRBs returned the newly stamped and dated forms in a timely fashion, study enrollment with valid consent forms was interrupted in 4 sites for periods of 2 to 13 weeks. Conclusions: IRB requirements not directly responsive to federal regulations can add significant costs, frustrations, and burdens to PBRN studies. Non–federally mandated IRB requirements should be based on an identified need with evidence to support the solution.

Repeated Depression Screening During the First Postpartum Year

PURPOSE Postpartum depression (PPD) screening at 4 to 12 weeks’ postpartum can improve outcomes for women when linked to in-practice management programs. The benefit of repeated PPD screening during the first year postpartum remains unclear. METHODS We report a substudy of a large pragmatic trial of early PPD screening and practice management, the Translating Research into Practice for Postpartum Depression (TRIPPD) study. Outcome analyses were based on demographic information and Patient Health Questionnaire (PHQ-9) screening scores from questionnaires mailed to all enrolled women at baseline (4 to 12 weeks’ postpartum) and again at 6 and at 12 months’ postpartum. The main outcomes of this substudy were the 6- and 12-month rates of PHQ-9 scores that were 10 or greater for women whose baseline PHQ-9 scores were less than 10. Women whose scores were 10 or greater would be considered at high risk of PPD and appropriate for further evaluation. RESULTS At 6 months, 134 (10.9%) of the 1,235 women who did not have PHQ-9 scores greater than 10 at baseline had elevated scores appropriate for further evaluation. At 12 months, 59 (6.1%) of the 969 women who did not have PHQ-9 scores greater than 10 at baseline or at 6 months had elevated scores. Together the 6- and 12-month repeated screenings identified 193 women at high risk of depression. This finding represents 13.5% of the 1,432 women whose screening results were negative for PPD at baseline. CONCLUSIONS Repeated PPD screening at 6 and 12 months’ postpartum increases the percentage of women identified as being at high risk of PPD. Further work will be required to understand the impact of this repeated screening on patient outcomes.

Communication is the Key to Success in Pragmatic Clinical Trials in Practice-based Research Networks (PBRNs)

Effective communication is the foundation of feasibility and fidelity in practice-based pragmatic research studies. Doing a study with practices spread over several states requires long-distance communication strategies, including E-mails, faxes, telephone calls, conference calls, and texting. Compared with face-to-face communication, distance communication strategies are less familiar to most study coordinators and research teams. Developing and ensuring comfort with distance communications requires additional time and use of different talents and expertise than those required for face-to-face communication. It is necessary to make sure that messages are appropriate for the medium, clearly crafted, and presented in a manner that facilitates practices receiving and understanding the information. This discussion is based on extensive experience of 2 groups who have worked collaboratively on several large, federally funded, pragmatic trials in a practice-based research network. The goal of this article is to summarize lessons learned to facilitate the work of other research teams.

How Well Does CAPTURE Translate?: An Exploratory Analysis of a COPD Case-Finding Method for Spanish-Speaking Patients

BACKGROUND: This study tested the properties of a Spanish translation of CAPTURE (COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk) with selective use of peak expiratory flow (PEF). METHODS: : This study comprised analyses of data from the Spanish‐speaking cohort of the cross‐sectional, case‐control study used to develop CAPTURE. Translation procedures included forward and backward translation, reconciliation, and cognitive interviewing to assure linguistic and cultural equivalence, yielding CAPTURE‐S. Spanish‐speaking participants were recruited through one center and designated as case subjects (clinically significant COPD: FEV1 ≤ 60% predicted and/or at risk of COPD exacerbation) or control subjects (no or mild COPD). Subjects completed a questionnaire booklet that included 44 candidate items, the COPD Assessment Test (CAT), and the modified Medical Research Council (mMRC) dyspnea question. PEF and spirometry were also performed. RESULTS: The study included 30 participants (17 case subjects and 13 control subjects). Their mean (± SD) age was 62.6 (11.49) years, and 33% were male. CAPTURE‐S scores were significantly correlated with PEF (r = –0.78), the FEV1/FVC ratio (r = –0.74), FEV1 (r = –0.69), FEV1 % predicted (r = –0.69), the CAT score (r = 0.70), and the mMRC dyspnea question (r = 0.59) (P < .0001), with significantly higher scores in case subjects than in control subjects (t = 6.16; P < .0001). PEF significantly correlated with FEV1 (r = 0.89), FEV1 % predicted (r = 0.79), and the FEV1/FVC ratio (r = 0.75) (P < .0001), with significantly lower PEF in case subjects than in control subjects (t = 5.08; P < .0001). CAPTURE‐S score + PEF differentiated case subjects and control subjects with a sensitivity of 88.2% and a specificity of 92.3%. CONCLUSIONS: CAPTURE‐S with selective use of PEF seems to be useful for identifying Spanish‐speaking patients in need of diagnostic evaluation for clinically significant COPD who may benefit from initiation of COPD treatment. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01880177; URL: www.clinicaltrials.gov.