Mary Jo White

Surveying physicians: do components of the "Total Design Approach" to optimizing survey response rates apply to physicians?

Background. Surveys serve essential roles in clinical epidemiology and health services research. However, physician surveys frequently encounter problems achieving adequate response rates. Research on enhancing response rates to surveys of the general public has led to the development of Dillman’s “Total Design Approach“ to the design and conduct of surveys. The impact of this approach on response rates among physicians is uncertain. Objective. To determine the extent to which the components of the total design approach have been found to be effective in physician surveys. Design. A systematic review. Results. The effectiveness of prepaid financial incentives, special contacts, and personalization to enhance response rates in surveys of physicians have been confirmed by the existing research. There is suggestive evidence supporting the use of first class stamps on return envelopes and multiple contacts. The optimum amount for incentives and the number of contacts necessary have not been established. Details of questionnaire design and their impact on response rates have received almost no attention from researchers. Few studies have assessed the usefulness of combinations of components of the total design approach. Conclusions. Despite the number of surveys conducted among physicians, their cost, the level of interest in their findings, and in spite of inadequate response rates, there have been few randomized trials conducted on important aspects of enhancing response in this population. Until this gap has been filled, researchers conducting surveys of physicians should consider including all components of the total design approach whenever feasible.

Randomized Trial of a Literacy-Sensitive, Culturally Tailored Diabetes Self-Management Intervention for Low-Income Latinos: Latinos en Control

OBJECTIVE To test whether a theory-based, literacy, and culturally tailored self-management intervention, Latinos en Control, improves glycemic control among low-income Latinos with type 2 diabetes. RESEARCH DESIGN AND METHODS A total of 252 patients recruited from community health centers were randomized to the Latinos en Control intervention or to usual care. The primarily group-based intervention consisted of 12 weekly and 8 monthly sessions and targeted knowledge, attitudes, and self-management behaviors. The primary outcome was HbA1c. Secondary outcomes included diet, physical activity, blood glucose self-monitoring, diabetes knowledge and self-efficacy, and other physiological factors (e.g., lipids, blood pressure, and weight). Measures were collected at baseline and at 4- and 12-month follow-up. Change in outcomes over time between the groups and the association between HbA1c and possible mediators were estimated using mixed-effects models and an intention-to-treat approach. RESULTS A significant difference in HbA1c change between the groups was observed at 4 months (intervention −0.88 [−1.15 to −0.60] versus control −0.35 [−0.62 to 0.07], P < 0.01), although this difference decreased and lost statistical significance at 12 months (intervention −0.46 [−0.77 to −0.13] versus control −0.20 [−0.53 to 0.13], P = 0.293). The intervention resulted in significant change differences in diabetes knowledge at 12 months (P = 0.001), self-efficacy (P = 0.001), blood glucose self-monitoring (P = 0.02), and diet, including dietary quality (P = 0.01), kilocalories consumed (P < 0.001), percentage of fat (P = 0.003), and percentage of saturated fat (P = 0.04). These changes were in turn significantly associated with HbA1c change at 12 months. CONCLUSIONS Literacy-sensitive, culturally tailored interventions can improve diabetes control among low-income Latinos; however, strategies to sustain improvements are needed.

Underutilizers of mammography screening today: Characteristics of women planning, undecided about, and not planning a mammogram

Using concepts from the Precaution Adoption Process Model, we identified behavioral factors, sociodemographic and psychosocial variables, and beliefs about breast cancer that discriminated among women at different stages with regard to their intention to obtain mammography screening. An independent survey company conducted telephone interviews with 2,507 women aged 50 to 80 who were identified as underutilizers of mammography screening. Each underutilizer was assigned to one of three stages with regard to intention to get a mammogram: (a) definitely planning, (b) thinking about, and (c) not planning. Estimated actual risk of breast cancer, perceived risk to breast cancer, worry about breast cancer, and fear of learning from a mammogram that one has breast cancer were variables found to be significantly associated with intention to obtain a mammogram for several subgroups of underutilizing women. There are significant behavioral and psychosocial variables, beliefs and feelings about breast cancer, and demographic characteristics that distinguish underutilizing women at various stages with regard to intention to obtain mammography screening. Our findings provide new information that could help the health care professional motivate women who are not planning to utilize this preventive health measure to become regular utilizers.

Promoting mammography: results of a randomized trial of telephone counseling and a medical practice intervention

BACKGROUND Despite widespread promotion of mammography screening, a distinct minority of women have remained underusers of this effective preventive measure. We sought to measure the effects of barrier-specific telephone counseling (BSTC) and a physician-based educational intervention (MD-ED) on mammography utilization among underusers of mammography screening. DESIGN This was a randomized controlled trial. Women meeting criteria for mammography underuse at baseline (grouped by practice affiliation) were randomized to a reminder control condition (RC group received annual mailed reminders), BSTC or MD-ED interventions and followed for 3 years. Underuse was defined by failure to get two annual or biannual mammograms over a 2- to 4-year period prior to a baseline survey. PARTICIPANTS AND SETTING The study included 1655 female underusers of mammography aged 50-80 years who were members of two health maintenance organizations (HMO) in central Massachusetts. INTERVENTIONS BSTC consisted of periodic brief, scripted calls from trained counselors to women who had not had a mammogram in the preceding 15 months. Women could receive up to three annual calls during the study. MD-ED consisted of physician and office staff trainings aimed at improving counseling skills and office reminder systems. MAIN OUTCOME MEASURE Self-report of mammography use during the study period was the main outcome measure. Regular use was defined as > or =1 mammogram every 24 months. RESULTS Forty-four percent in each intervention group became regular users compared to 42% in the RC group. Among subjects who had prior but not recent mammograms at baseline, BSTC was effective (OR=1.48; 95% CI=1.04; 2. 10), and MD-ED marginally effective (OR=1.28; 95% CI=0.88, 1.85). Most recent users at baseline and few never users became regular users (61% and 17%, respectively) regardless of intervention status. CONCLUSIONS Among mammography underusers BSTC modestly increases utilization for former users at a reasonable cost (

Translational research at community health centers: challenges and successes in recruiting and retaining low-income Latino patients with type 2 diabetes into a randomized clinical trial.

726 per additional regular user).

Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-Income Latinos: Latinos en Control

Purpose To describe methods used to recruit and retain low-income Latinos in a randomized clinical trial (RCT) of a diabetes self-management intervention at 5 community health centers (CHCs) in Massachusetts. Methods Consent from primary care providers (PCPs) was obtained to screen their patients. Trained site research coordinators (SRCs) screened, recruited, and enrolled participants following a multistep process (medical record reviews, PCP approval, a patient eligibility interview) and provided support for retention efforts. Assessment staff were trained in motivational strategies to facilitate retention and received ongoing support from a retention coordinator. Electronic tracking systems facilitated recruitment and retention activities. Results Of an initial pool of 1176 patients, 1034 were active at the time of screening, 592 (57%) were eligible by medical record review, and 487 received PCP approval (92% of reviewed patients). Of these, 293 patients completed the patient screening interview (60% of patients with PCP approval, and 76% of those reached), and 276 were eligible. Sixteen percent of all active patients refused participation, and 8% of contacted patients were unreachable. Two hundred fifty-two patients were randomized after completion of baseline assessments. Clinical, behavioral, and psychosocial assessment completion rates were 92%, 77%, and 86% at 12-month follow-up, respectively, and 93% of patients completed at least one study assessment at 12 months. Conclusions CHCs are a prime setting for translation research aimed to eliminate diabetes health disparities. Successful recruitment and retention efforts must address institutional/organizational, research team, and patient-related challenges. References 1. US Department of Health and Human Services, Centers for Disease Control and Prevention. Age-adjusted prevalence of diagnosed diabetes by race/ethnicity and sex in the United States, 1980-2005. Available at: www.cdc.gov/diabetes/statistics/prev/ national/figraceethsex.htm. Accessed January 21, 2010. 2. US Census Bureau. Annual estimates of the population by sex, race, and Hispanic or Latino origin for the United States: April 1, 2000 to July 1, 2006. Available at: www.census.gov/popest/ national/asrh/NC-EST2006-srh.html. Accessed January 21, 2010. 3. National Center for Health Statistics. Early release of selected estimates based on data from the January-September 2006 National Health Interview Survey. Available at: http://www. cdc.gov/nchs/about/major/nhis/released200703.htm. Accessed January 12, 2010. 4. Centers for Disease Control and Prevention. Self-reported prevalence of diabetes among Hispanics: United States, 1994-1997. MMWR. 1999;48:8-12. 5. Harris MI, Klein R, Cowie CC, Rowland M, Byrd-Holt DD. Is the risk of diabetic retinopathy greater in non-Hispanic blacks and Mexican Americans than in non-Hispanic whites with type 2 diabetes? A U.S. population study. Diabetes Care. 1998; 21:1230-1235. 6. Franklin GM, Kahn LB, Baxter J, Marshall JA, Hamman RF. Sensory neuropathy in non-insulin-dependent diabetes mellitus: the San Luis Valley Diabetes Study. Am J Epidemiol . 1990;131:633-643. 7. Agency for Healthcare Research and Quality. National Healthcare Disparities Report, 2006. Rockville, MD: Agency for Healthcare Research and Quality; 2006. Available at: http://www.ahrq.gov/ qual/nhdr06/nhdr06.htm. Accessed January 12, 2010. 8. National Institute of Diabetes and Digestive and Kidney Diseases, National Diabetes Information Clearinghouse (NDIC). National diabetes statistics. Available at: http://diabetes.niddk.nih.gov/dm/ pubs/statistics/index.htm. Accessed January 12, 2010. 9. US Department of Health and Human Services, Office of Minority Research. Diabetes and Hispanic Americans. Available at: http://www.omhrc.gov/templates/content.aspx?lvl=2&lvllD= 54&ID=3324. Accessed December 10, 2009. 10. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;329 :977-986. 11. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352:837-853. 12. Norris SL, Engelgau MM, Narayan KM. Effectiveness of self-management training in type 2 diabetes: a systematic review of randomized controlled trials. Diabetes Care. 2001;24:561-587. 13. Brown SA, Garcia AA, Kouzekanani K, Hanis CL. Culturally competent diabetes self-management education for Mexican Americans: the Starr County border health initiative. Diabetes Care. 2002;25:259-268. 14. Lorig K, Ritter PL, Villa F, Piette JD. Spanish diabetes self-management with and without automated telephone reinforcement: two randomized trials. Diabetes Care. 2008; 31:408-414. 15. Rosal MC, Olendzki B, Reed GW, Gumieniak O, Scavron J, Ockene IS. Diabetes self-management among low-income Spanish speaking patients: a pilot study. Ann Behav Med. 2005;29:225-235. 16. Mauldon M, Melkus GD, Cagganello M. Tomando Control: a culturally appropriate diabetes education program for Spanish-speaking individuals with type 2 diabetes mellitus. Evaluation of a pilot project. Diabetes Educ. 2006;32:751-760. 17. Centers for Disease Control and Prevention, National Center for Health Statistics. Age-adjusted percentage of civilian, noninstitutionalized population with diagnosed diabetes, Hispanics, United States, 1980-2007. Available at: http://www.ced.gov/diabetes/ statistics/prev/national/figbyhispanic.htm. Accessed March 31, 2010. 18. Flegal KM, Ezzati TM, Harris MI. Prevalence of diabetes in Mexican Americans, Cubans, and Puerto Ricans from the Hispanic health and nutrition examination survey 1982-1984. Diabetes Care. 1991;14(7 Suppl):528-538. 19. Lemon SC, Zapka JG, Estabrook B, Benjamin E. Challenges to research in urban community health centers. Am J Public Health. 2006;96:626-628. 20. Handley MA, Hammer H, Schillinger D. Navigating the terrain between research and practice: a Collaborative Research Network (CRN) case study in diabetes research. J Am Board Fam Med. 2006;19:85-92. 21. Piatt GA, Orchard TJ, Emerson S. Translating the chronic care model into the community: results from a randomized controlled trial of a multifaceted diabetes care intervention. Diabetes Care. 2006;29:811-817. 22. Frayne SM, Burns RB, Hardt EJ, Rosen AK, Moskowitz MA. The exclusion of non-English-speaking persons from research. J Gen Intern Med. 1996;11:39-43. 23. Durant RW, Davis RB, St George M, Williams IC, Blumenthal C, Corbie-Smith GM. Participation in research studies: factors associated with failing to meet minority recruitment goals. Ann Epidemiol. 2007;17:634-642. 24. Centers for Disease Control and Prevention, Department of Health and Human Services. Diabetes data and trends. Available at: http:www.cdc.gov/diabetes/statistics/prev/national/. Accessed March 31, 2010. 25. Surani S, Aguillar R, Komari V, Surani A, Subramanian S. Influence of Hispanic ethnicity in prevalence of diabetes mellitus in sleep apnea and relationship to sleep phase. Postgrad Med. 2009;121:108-112. 26. Link CL, McKinlay JB. Disparities in the prevalence of diabetes: is it race/ethnicity or socioeconomic status? Results from the Boston Area Community Health (BACH) survey. Ethn Dis. 2009;19:288-292. 27. Bryson CL, Ross HJ, Boyko EJ, Young BA. Racial and ethnic variations in albuminuria in the US Third National Health and Nutrition Examination Survey (NHANES III) population: associations with diabetes and level of CKD. Am J Kidney Dis. 2006; 48:720-726. 28. Gross R, Olfson M, Gameroff MJ. Depression and glycemic control in Hispanic primary care patients with diabetes. J Gen Intern Med. 2005;20:460-466. 29. Trief PM, Morin PC, Izquierdo R. Depression and glycemic control in elderly ethnically diverse patients with diabetes: the IDEATel project. Diabetes Care. 2006; 29:830-835. 30. McCarthy CR. Historical background of clinical trials involving women and minorities. Acad Med . 1994;69:695-698. 31. Rosal MC, Benjamin EM, Pekow PS, Lemon SC, von Goeler D. Opportunities and challenges for diabetes prevention at two community health centers. Diabetes Care. 2008; 31:247-254. 32. Blumenthal DS, Sung J, Coates R, Williams J, Liff J. Recruitment and retention of subjects for a longitudinal cancer prevention study in an inner-city black community. Health Serv Res. 1995;30(1 Pt 2):197-205. 33. UyBico SJ, Pavel S, Gross CP. Recruiting vulnerable populations into research: a systematic review of recruitment interventions. J Gen Intern Med. 2007;22:852-863. 34. Corbie-Smith GM. Minority recruitment and participation in health research. N C Med J. 2004; 65:385-387. 35. Bruner DW, Jones M, Buchanan D, Russo J. Reducing cancer disparities for minorities: a multidisciplinary research agenda to improve patient access to health systems, clinical trials, and effective cancer therapy. J Clin Oncol. 2006;24:2209-2215. 36. Blumenthal DS, Lukomnik JE, Hawkins DR, Jr. A proposal to provide care to the uninsured through a network of community health centers. J Health Care Poor Underserved. 1993;4:272-279. 37. Davis SK, Collins KS, Hall A. Community health centers in a changing U.S. health care system. Policy Brief Commonw Fund . 1999;(300):1-13. 38. US Department of Health and Human Services, Health Resources and Services Administration. Bureau of Primary Health Care. America’s health centers: models for quality primary health care. Available at: http://bphc.hrsa.gov/chc/charts/healthcenters.htm. Accessed January 8, 2010. 39. Rosal MC, White MJ, Restrepo A. Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-income Latinos: Latinos en Control. BMC Med Res Methodol. 2009;9:81. 40. Miller WR, Rollnick S. Motivational Interviewing: Preparing People for Change. 2n

Helping men make an informed decision about prostate cancer screening: A pilot study of telephone counseling

BackgroundUS Latinos have greater prevalence of type 2 diabetes (diabetes), uncontrolled diabetes and diabetes co-morbidities compared to non-Latino Whites. They also have lower literacy levels and are more likely to live in poverty. Interventions are needed to improve diabetes control among low-income Latinos.Methods and designThis randomized clinical trial tested the efficacy of a culturally- and literacy-tailored diabetes self-management intervention (Latinos en Control) on glycemic control among low-income Latinos with diabetes, compared to usual care (control). Participants were recruited from five community health centers (CHCs) in Massachusetts. The theory-based intervention included an intensive phase of 12 weekly sessions and a follow-up maintenance phase of 8 monthly sessions. Assessments occurred at baseline, and at 4 and 12 months. The primary outcome was glycosylated hemoglobin (HbA1c). Secondary outcomes were self-management behaviors, weight, lipids and blood pressure. Additional outcomes included diabetes knowledge, self-efficacy, depression and quality of life. The study was designed for recruitment of 250 participants (estimated 20% dropout rate) to provide 90% power for detecting a 7% or greater change in HbA1c between the intervention and control groups. This is a difference in change of HbA1c of 0.5 to 0.6%.DiscussionLow-income Latinos bear a great burden of uncontrolled diabetes and are an understudied population. Theory-based interventions that are tailored to the needs of this high-risk population have potential for improving diabetes self-management and reduce health disparities. This article describes the design and methods of a theory driven intervention aimed at addressing this need.Trial registrationhttp://www.clinicaltrials.gov # NCT00848315

Staging mammography nonadherent women: A qualitative study

OBJECTIVE Evaluate a computer-assisted telephone counseling (CATC) decision aid for men considering a prostate specific antigen (PSA) test. METHODS Eligible men were invited by their primary care providers (PCPs) to participate. Those consenting received an educational booklet followed by CATC. The counselor assessed stage of readiness, reviewed booklet information, corrected knowledge deficits and helped with a values clarification exercise. The materials presented advantages and disadvantages of being screened and did not advocate for testing or for not testing. Outcome measures included changes in stage, decisional conflict, decisional satisfaction, perceived vulnerability and congruence of a PSA testing decision with a pros/cons score. Baseline and final surveys were administered by telephone. RESULTS There was an increase in PSA knowledge (p<0.001), and in decisional satisfaction (p<0.001), a decrease in decisional conflict (p<0.001), and a general consistency of those decisions with the mans values. Among those initially who had not made a decision, 83.1% made a decision by final survey with decisions equally for or against screening. CONCLUSIONS The intervention provides realistic, unbiased and effective decision support for men facing a difficult and confusing decision. PRACTICE IMPLICATIONS Our intervention could potentially replace a discussion of PSA testing with the PCP for most men.

Basic Skills for Working With Smokers: A Pilot Test of an Online Course for Medical Students*

Background. Few studies have related stages of mammography screening nonadherence with the rationale used by overdue women. Methods. We used a grounded theory approach to obtain and analyze data from focus groups, telephone interviews, and surveys. Emergent specific themes were compared with emerging decision levels of nonadherence. Each decision level was then compared with the Precaution Adoption Process Model and the Transtheoretical Model. Results. A total of 6 key themes influencing mammogram nonadherence emerged as did 6 decision levels. Variability within themes was associated with specific decision levels. The decision levels were not adequately classified by either stage model. Conclusions. Stage-based educational strategies may benefit by tailoring interventions to these 6 decision levels.

Design and methods for a randomized clinical trial comparing three outreach efforts to improve screening mammography adherence

Background. Online learning can be an excellent method for presenting clinical skills to address health behaviors.Methods. Medical students pilot tested a skills-building course consisting of an online component and a practical application.Results. A total of 38 students were registered, 25 (66%) completed the online component, and 22 (58%) completed both course components. Students reported they were adequately trained to administer the brief 5A intervention to patients who smoke and they intended to deliver the intervention routinely.Conclusions. Online skill-building courses can have a positive effect on students’ knowledge and skills and can be used across health behaviors promote healthy lifestyles.