Sharon J. Rolnick

Lessons from Experienced Guideline Implementers: Attend to Many Factors and Use Multiple Strategies

BACKGROUND Studies of clinical guideline implementation have focused almost entirely on changing individual clinician behavior with single intervention strategies and without much attention to the situational context. The goal of this project was to learn from clinic leaders, seasoned in the guideline implementation process, what contextual variables they viewed as important and whether implementation success could be expected if only a single implementation strategy was used. METHODS In 1998, 12 people with extensive experience in leading clinical guideline implementation were identified who were thought to have particularly keen insight into the process. They were interviewed to generate variables they considered important, as well as strategies they considered effective when used appropriately. A modified nominal group/Delphi process was then used for rating these variables and strategies, and the reactions of international experts were obtained to add perspective to this information. RESULTS Eighty-seven variables and 25 strategies were identified, clustering in 6 categories (ranked in order of importance by the panel): organizational capabilities for change, infrastructure for implementation, implementation strategies, medical group characteristics, guideline characteristics, and external environment. All six categories were considered to be important, key, or essential by the experienced implementers, although variables within a medical group that directly affect its ability to undertake planned change were rated as much more important than either guideline characteristics or the external environment. DISCUSSION Although the opinions of those experienced in the process of guideline implementation are primarily of value for generating hypotheses, panel members believe that implementation efforts focusing on the individual physician with a single strategy are unlikely to be successful. Rather, implementation efforts must use multiple strategies that take account of multiple characteristics of the guideline, practice organization, and external environment.

Efficacy of Prophylactic Mastectomy in Women With Unilateral Breast Cancer: A Cancer Research Network Project

PURPOSE We investigated the efficacy of contralateral prophylactic mastectomy (CPM) in reducing contralateral breast cancer incidence and breast cancer mortality among women who have already been diagnosed with breast cancer. METHODS This retrospective cohort study comprised approximately 50,000 women who were diagnosed with unilateral breast cancer during 1979 to 1999. Using computerized data confirmed by chart review, we identified 1,072 women (1.9%) who had CPM. We obtained covariate information for these women and for a sample of 317 women who did not undergo CPM. RESULTS The median time from initial breast cancer diagnosis to the end of follow-up was 5.7 years. Contralateral breast cancer developed in 0.5% of women with CPM, metastatic disease developed in 10.5%, and subsequent breast cancer developed in 12.4%; 8.1% died from breast cancer. Contralateral breast cancer developed in 2.7% of women without CPM, and 11.7% died of breast cancer. After adjustment for initial breast cancer characteristics, treatment, and breast cancer risk factors, the hazard ratio (HR) for the occurrence of contralateral breast cancer after CPM was 0.03 (95% CI, 0.006 to 0.13). After adjustment for breast cancer characteristics and treatment, the HRs for the relationship of CPM with death from breast cancer, with death from other causes, and with all-cause mortality were 0.57 (95% CI, 0.45 to 0.72), 0.78 (95% CI, 0.57 to 1.06), and 0.60 (95% CI, 0.50 to 0.72), respectively. CONCLUSION CPM seems to protect against the development of contralateral breast cancer, and although women who underwent CPM had relatively low all-cause mortality, CPM also was associated with decreased breast cancer mortality.

Patient Characteristics Associated with Medication Adherence

Objective Despite evidence indicating therapeutic benefit for adhering to a prescribed regimen, many patients do not take their medications as prescribed. Non-adherence often leads to morbidity and to higher health care costs. The objective of the study was to assess patient characteristics associated with medication adherence across eight diseases. Design Retrospective data from a repository within an integrated health system was used to identify patients ≥18 years of age with ICD-9-CM codes for primary or secondary diagnoses for any of eight conditions (depression, hypertension, hyperlipidemia, diabetes, asthma or chronic obstructive pulmonary disease, multiple sclerosis, cancer, or osteoporosis). Electronic pharmacy data was then obtained for 128 medications used for treatment. Methods Medication possession ratios (MPR) were calculated for those with one condition and one drug (n=15,334) and then for the total population having any of the eight diseases (n=31,636). The proportion of patients adherent (MPR ≥80%) was summarized by patient and living-area (census) characteristics. Bivariate associations between drug adherence and patient characteristics (age, sex, race, education, and comorbidity) were tested using contingency tables and chi-square tests. Logistic regression analysis examined predictors of adherence from patient and living area characteristics. Results Medication adherence for those with one condition was higher in males, Caucasians, older patients, and those living in areas with higher education rates and higher income. In the total population, adherence increased with lower comorbidity and increased number of medications. Substantial variation in adherence was found by condition with the lowest adherence for diabetes (51%) and asthma (33%). Conclusions The expectation of high adherence due to a covered pharmacy benefit, and to enhanced medication access did not hold. Differences in medication adherence were found across condition and by patient characteristics. Great room for improvement remains, specifically for diabetes and asthma.

Self-report compared to electronic medical record across eight adult vaccines: Do results vary by demographic factors?

Immunizations are crucial to the prevention of disease, thus, having an accurate measure of vaccination status for a population is an important guide in targeting prevention efforts. In order to comprehensively assess the validity of self-reported adult vaccination status for the eight most common adult vaccines we conducted a survey of vaccination receipt and compared it to the electronic medical record (EMR), which was used as the criterion standard, in a population of community-dwelling patients in a large healthcare system. In addition, we assessed whether validity varied by demographic factors. The vaccines included: pneumococcal (PPSV), influenza (Flu), tetanus diphtheria (Td), tetanus diphtheria pertussis (Tdap), Human Papilloma Virus (HPV), hepatitis A (HepA), hepatitis B (HepB) and herpes zoster (shingles). Telephone surveys were conducted with 11,760 individuals, ≥18, half with documented receipt of vaccination and half without. We measured sensitivity, specificity, positive and negative predictive value, net bias and over- and under-reporting of vaccination. Variation was found across vaccines, however, sensitivity and specificity did not vary substantially by either age or race/ethnicity. Sensitivity ranged between 63% for HepA to over 90% (tetanus, HPV, shingles and Flu). Hispanics were 2.7 times more likely to claim receipt of vaccination compared to whites. For PPSV and Flu those 65+ had low specificity compared to patients of younger ages while those in the youngest age group had lowest specificity for HepA and HepB. In addition to racial/ethnic differences, over-reporting was more frequent in those retired and those with household income less than

A Randomized Clinical Trial Evaluating Online Interventions to Improve Fruit and Vegetable Consumption

75,000. Accurate information for vaccination surveillance is important to estimate progress toward vaccination coverage goals and ensure appropriate policy decisions and allocation of resources for public health. It was clear from our findings that EMR and self-report do not always agree. Finding approaches to improve both EMR data capture and patient awareness would be beneficial.

Contentment With Quality of Life Among Breast Cancer Survivors With and Without Contralateral Prophylactic Mastectomy

OBJECTIVES We assessed change in fruit and vegetable intake in a population-based sample, comparing an online untailored program (arm 1) with a tailored behavioral intervention (arm 2) and with a tailored behavioral intervention plus motivational interviewing-based counseling via e-mail (arm 3). METHODS We conducted a randomized controlled intervention trial, enrolling members aged 21 to 65 years from 5 health plans in Seattle, Washington; Denver, Colorado; Minneapolis, Minnesota; Detroit, Michigan; and Atlanta, Georgia. Participants reported fruit and vegetable intake at baseline and at 3, 6, and 12 months. We assessed mean change in fruit and vegetable servings per day at 12 months after baseline, using a validated self-report fruit and vegetable food frequency questionnaire. RESULTS Of 2540 trial participants, 80% were followed up at 12 months. Overall baseline mean fruit and vegetable intake was 4.4 servings per day. Average servings increased by more than 2 servings across all study arms (P<.001), with the greatest increase (+2.8 servings) among participants of arm 3 (P=.05, compared with control). Overall program satisfaction was high. CONCLUSIONS This online nutritional intervention was well received, convenient, easy to disseminate, and associated with sustained dietary change. Such programs have promise as population-based dietary interventions.

Patterns and predictors of mammography utilization among breast cancer survivors

PURPOSE To understand psychosocial outcomes after prophylactic removal of the contralateral breast in women with unilateral breast cancer. METHODS We mailed surveys to women with contralateral prophylactic mastectomy after breast cancer diagnosis between 1979 and 1999 at six health care delivery systems, and to a smaller random sample of women with breast cancer without the procedure. Measures were modeled on instruments developed to assess contentment with quality of life, body image, sexual satisfaction, breast cancer concern, depression, and health perception. We examined associations between quality of life and the other domains using logistic regression. RESULTS The response rate was 72.6%. Among 519 women who underwent contralateral prophylactic mastectomy, 86.5% were satisfied with their decision; 76.3% reported high contentment with quality of life compared with 75.4% of 61 women who did not undergo the procedure (P = .88). Among all case subjects, less contentment with quality of life was not associated with contralateral prophylactic mastectomy or demographic characteristics, but was associated with poor or fair general health perception (odds ratio [OR], 7.0; 95% CI, 3.4 to 14.1); possible depression (OR, 5.4; 95% CI, 3.1 to 9.2); dissatisfaction with appearance when dressed (OR, 3.5; 95% CI, 2.0 to 6.0); self-consciousness about appearance (OR, 2.0; 95% CI, 1.1 to 3.7); and avoiding thoughts about breast cancer (modest: OR, 2.2; 95% CI, 1.1 to 4.5; highest: OR, 1.7; 95% CI, 0.9 to 3.2). CONCLUSION Most women undergoing contralateral prophylactic mastectomy report satisfaction with their decision and experience psychosocial outcomes similar to breast cancer survivors without the procedure.

Positive, Negative, and Disparate—Women’s Differing Long‐Term Psychosocial Experiences of Bilateral or Contralateral Prophylactic Mastectomy

Improvements in cancer detection and treatment have resulted in increasing numbers of breast cancer survivors. Information regarding the use of mammography by breast cancer survivors is limited.

Recruitment to a Randomized Web-Based Nutritional Intervention Trial: Characteristics of Participants Compared to Non-Participants

Abstract:  Because of recent studies showing strong prevention benefit and acceptable psychosocial outcomes, more women may be considering prophylactic mastectomy. A growing literature shows some positive psychosocial outcomes for women with bilateral prophylactic mastectomy, but less is known about women with contralateral prophylactic mastectomy. Several surveys have shown that a large majority of women with prophylactic mastectomy report satisfaction with their decisions to have the procedure when asked in a quantitative, closed‐ended format. We sought to explore the nuances of women’s satisfaction with the procedure using a qualitative, open‐ended format. We included open‐ended questions as part of a mailed survey on psychosocial outcomes of prophylactic mastectomy. The research team coded and analyzed these responses using qualitative methods. We used simple descriptive statistics to compare the demographics of the entire survey sample to those women who answered the open‐ended questions; the responses to the open‐ and closed‐ended satisfaction questions, and the responses of women with bilateral and contralateral prophylactic mastectomy. Seventy‐one percent of women with prophylactic mastectomy responded to the survey and 48% provided open‐ended responses about psychosocial outcomes. Women’s open‐ended responses regarding psychosocial outcomes could be coded into one of three general categories—positive, negative, and disparate. In the subgroup of women with both open‐and closed‐ended responses, over 70% of women providing negative and disparate comments to the open‐ended question simultaneously indicated satisfaction on a closed‐ended question. Negative and disparate open‐ended responses were twice as common among women with bilateral prophylactic mastectomy (52%) than women with contralateral prophylactic mastectomy (26%). These findings suggest that even among women who report general satisfaction with their decision to have prophylactic mastectomy via closed‐ended survey questions, lingering negative psychosocial outcomes can remain, particularly among women with bilateral prophylactic mastectomy. This dichotomy could be an important factor to discuss in counseling women considering the procedure.

Quality of Life After Bilateral Prophylactic Mastectomy

Background Web-based behavioral programs efficiently disseminate health information to a broad population, and online tailoring may increase their effectiveness. While the number of Internet-based behavioral interventions has grown in the last several years, additional information is needed to understand the characteristics of subjects who enroll in these interventions, relative to those subjects who are invited to enroll. Objective The aim of the study was to compare the characteristics of participants who enrolled in an online dietary intervention trial (MENU) with those who were invited but chose not to participate, in order to better understand how these groups differ. Methods The MENU trial was conducted among five health plans participating in the HMO Cancer Research Network in collaboration with the University of Michigan Center for Health Communication Research. Approximately 6000 health plan members per site, between the ages of 21 and 65, and stratified by gender with oversampling of minority populations, were randomly selected for recruitment and were mailed an invitation letter containing website information and a US