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.

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.

Preventing the voltage drop: keeping practice-based research network (PBRN) practices engaged in studies.

INTRODUCTION: Practice-based research continues to evolve and has become a major methodology for many pragmatic studies. While early practice-based network projects were usually short term, current studies often introduce or compare practice innovations that require long-term evaluation. That change requires that practice sites remain engaged in research work for up to 5 years, a time that can allow for a significant "voltage drop," or decline in active participation. METHODS: Over the past 15 years we have developed and adapted several strategies to facilitate and encourage the continued active engagement of practices in practice-based research network studies of up to 5 years' duration. The concepts, details, evaluation, and results (when available) of the strategies are described. RESULTS: Eight strategies that enhance practice sites' attention to enrollment, data collection and continued use of the implemented practice change are described. CONCLUSION: The loss of momentum, or "voltage drop," that happens in longer-term practice-based research network studies can be addressed using multiple strategies.

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.

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

BACKGROUND: Patient-centered diabetes care requires shared decision making (SDM). Decision aids promote SDM, but their efficacy in nonacademic and rural primary care clinics is unclear. METHODS: We 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. RESULTS: Compared 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. CONCLUSION: DAs 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 REGISTRATION: NCT01029288.

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.

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.

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.

Comparison of parent and student responses to asthma surveys: students grades 3-12 and their parents from a suburban private school setting.

Schools are being called upon to help address asthma, a common problem in school-aged children. School-based asthma programs need information about asthma diagnoses, asthma symptoms, and asthma's impact on school attendance. Parent or student surveys are the most common method of collecting these data. However, medical literature offers little guidance to help schools determine whether parents or students are the most appropriate and effective source of asthma-related information. This study compares student and parent responses to the same set of asthma-related questions. In general, parents and students have a high level of agreement in reporting the absence of an asthma diagnosis or asthma symptoms. When parents and students disagreed, students reported many more asthmalike symptoms, especially symptoms with exercise and symptoms at night, than did their parents. The disparity in student and parent symptom reporting did not vary by age of the student. Students appear to provide the most sensitive measure of asthma-related problems.

Feasibility of school-based spirometry screening for asthma.

To determine the feasibility and value of spirometry in school-based asthma screening, spirometry testing was coupled with parent questionnaires in a school-based asthma screening project. Children in grades five to eight of the Catholic school system in Rochester, Minn., performed spirometry with coaching and data acquisition by nurses trained for this activity. Most students completed three tests. For each student, the best test was selected for interpretation. Tests were considered technically unacceptable for screening purposes if the FEV1 was less than 85% and the curve showed evidence of cough, delayed start, poor initial effort, incomplete effort, or non-reproducibility. Students with acceptable tests and FEV1 < 85% as predicted for age, race, and BMI were classified as appropriate for referral for further evaluation of potential asthma. A sensitivity analysis was conducted using different FEV1 thresholds for referral. Children (119, 17.6% of all) with known asthma based on parent-completed questionnaire were not considered for referral. Of the remaining 557 students screened, 535 had technically acceptable tests, and 498 had normal spirometry performance. Using a threshold for referral of FEV1 < 85%, 37 children were candidates for referral for further evaluation of potential asthma. Only four (11%) of these also had questionnaire responses that made them candidates for referral. School-based spirometry screening for asthma is technically feasible but there is little overlap between those who are referral candidates based on spirometry data and those who are referral candidates based on parent-reported symptoms on screening questionnaires. Without further study, spirometry cannot be recommended for school-based asthma screening.

A longitudinal study of the prevalence of asthma in a community population of school-age children.

OBJECTIVE: Using a unique county-wide resource that links all health care providers' medical records to assess current and "ever" prevalence of physician-diagnosed asthma. To describe the age and sex rates and temporal trends in new asthma diagnoses and associations with race and socio-economic status. STUDY DESIGN: A longitudinal retrospective evaluation of a population-based cohort of school children using linked medical and school records. RESULTS: Overall, 17.6% of children in grades kindergarten through 12 had a physician diagnosis of asthma and 12.9% had an asthma-related visit within the past 2 years. An additional 19.7% had visits for reactive airway disease or recurrent wheezing or bronchospasm with no diagnosis of asthma. Children provided with free and reduced-cost lunches had lower cumulative and incident asthma rates from birth through their current school age. Race was not related to rates of physician-diagnosed asthma. There was a significant temporal increase in rates of new asthma diagnoses. CONCLUSIONS: In this community, 1 in 3 children have had a physician-documented recurrent wheezing-type illness, and 1 in 6 were diagnosed with asthma. Diagnoses rates were directly related to socioeconomic status.