Erin N. Marcus

Improving the Informed Consent Process for Research Subjects with Low Literacy: A Systematic Review

ABSTRACTBACKGROUNDInadequate health literacy may impair research subjects’ ability to participate adequately in the informed consent (IC) process. Our aim is to evaluate the evidence supporting interventions, to improve comprehension of the IC process in low literacy subjects.METHODSWe performed a MEDLINE database search (1966 to November 2011) supplemented by manual searches of bibliographies of key relevant articles. We selected all studies in which a modification of the IC was tested to improve comprehension in low literacy populations. Study design, quality criteria, population, interventions and outcomes for each trial were extracted. The main outcome evaluated was comprehension, measured using a written test or verbal comprehension.RESULTSOur search strategy yielded 281 studies, of which only six met our eligibility criteria. The six studies included 1620 research participants. The studies predominantly included populations that were older (median age 61, range 48–64), ethnic minority, and with literacy level of 8th grade or below. Only one study had a randomized design. The specific intervention differed in each study. Two of the studies included the teach-back method or teach to goal method and achieved the highest level of comprehension. Two studies changed the readability level of the IC and resulted in the lowest comprehension among study subjects.CONCLUSIONSThe evidence supporting interventions to improve the informed consent process in low literacy populations is extremely limited. Among the interventions evaluated, having a study team member spend more time talking one-on-one to study participants was the most effective strategy for improving informed consent understanding; however, this finding is based on the results of a single study.

Elevated CA 19-9 levels in a patient with Mirizzi syndrome: case report.

CA 19-9 is a marker of malignancy of the pancreas and biliary tract. We report the case of a patient who had significantly elevated serum CA 19-9 levels and imaging studies suggestive of malignancy. On laparotomy, the patient was found to have Mirizzi syndrome, an uncommon cause of biliary obstruction from an impacted gallstone. This case illustrates that elevated serum CA 19-9 levels must be interpreted cautiously in cases of biliary obstruction.

Urban women's preferences for learning of their mammogram result: A qualitative study

Research suggests that communication of mammogram results is flawed for many low-income ethnic minority women. This study conducted four focus groups with low-income inner-city minority women (n = 34). The goals of our project were: (1) to elucidate womens experiences learning of their result; (2) to elicit their preferences as to how this communication could be improved; and (3) to gather information to help inform the development of a new tool for communicating mammogram results. Salient themes included dissatisfaction with result communication; difficulty elucidating the meaning of a typical results notification letter; a preference for direct verbal communication of results and for print materials that included pictures, testimonials, and an action plan including a hotline to call with questions; and a strong interest in advance education about the likelihood of having to return for additional follow up. Video and other programs to inform patients before the test about what happens after may improve patient satisfaction and enhance womens understanding of their personal result and follow up plan.

Mammography Result Notification Letters: Are They Easy to Read and Understand?

BACKGROUND Federal law mandates that mammography centers notify women of their result in writing. The purpose of this study is to assess the readability and ease of use of the sample letters provided as a template for the notification letters centers send to patients. METHODS This is a cross-sectional analysis of the 43 mammography result notification template letters available from the American College of Radiology and two leading transcription software services. To assess readability, we used the Flesch-Kincaid grade level scale and the Lexile framework. To assess document suitability, we used the Suitability Assessment of Materials (SAM). Acceptable scores were based on established standards: ≤6th grade for the Flesch-Kincaid level, ≤900 for the Lexile analysis, and ≥40% on the SAM scale. Means, standard deviations (SDs), and ranges were calculated by diagnostic category, as indicated by BI-RADS level. The Kruskal-Wallis test was used to assess differences in readability and suitability by diagnostic category. RESULTS The Flesch Kincaid score ranged from 7.7 to 13.5, with a mean of 10.2. The Lexile score ranged from 880 to 1270, with a mean of 1113. The mean SAM score ranged from 16% to 36%, with a mean of 29%. Mean grade level, Lexile score, and SAM score did not vary significantly by diagnostic category. No single document had an acceptable suitability score, and only two had acceptable Lexile scores. Common deficiencies included use of the passive voice, vague wording, and technical jargon. CONCLUSIONS The letters we analyzed were written at levels too difficult for many patients to understand. Future investigations should explore clearer ways of communicating mammography results.

Acceptability and Feasibility of Human Papilloma Virus Self-Sampling for Cervical Cancer Screening

OBJECTIVES Women in safety-net institutions are less likely to receive cervical cancer screening. Human papilloma virus (HPV) self-sampling is an alternative method of cervical cancer screening. We examine the acceptability and feasibility of HPV self-sampling among patients and clinic staff in two safety-net clinics in Miami. MATERIALS AND METHODS Haitian and Latina women aged 30-65 years with no Pap smear in the past 3 years were recruited. Women were offered HPV self-sampling or traditional Pap smear screening. The acceptability of HPV self-sampling among patients and clinic staff was assessed. If traditional screening was preferred the medical record was reviewed. RESULTS A total of 180 women were recruited (134 Latinas and 46 Haitian). HPV self-sampling was selected by 67% women. Among those selecting traditional screening, 22% were not screened 5 months postrecruitment. Over 80% of women agreed HPV self-sampling was faster, more private, easy to use, and would prefer to use again. Among clinic staff, 80% agreed they would be willing to incorporate HPV self-sampling into practice. CONCLUSIONS HPV self-sampling was both acceptable and feasible to participants and clinic staff and may help overcome barriers to screening.

Does a bite cause cancer? Misperceptions of breast cancer etiology among low-income urban women in Miami, Florida.

Objectives To explore breast cancer beliefs among a cohort of low-income, urban, English-speaking women in Miami, Florida, who had undergone screening mammography. Methods Four focus groups of 34 women were conducted. Discussions were transcribed verbatim and transcripts were analyzed separately by two investigators using an immersion–and-crystallization approach. Common risk factors were identified by consensus. Results Participants were predominantly African American (82%) women of low income (77% with a household income <

The conundrum of explaining breast density to patients.

20,000/year). Common risk factors included family history, environmental factors, trauma, and sexual activity. There also was a perception that breast cancer grows rapidly and causes detectable symptoms. Conclusions Women voiced some accurate and numerous inaccurate beliefs regarding the causes of breast cancer, suggesting a lack of knowledge about the potential benefits and harms of screening mammography before undergoing examination. These findings highlight the importance of identifying women’s underlying beliefs when initiating a discussion of breast cancer screening and prevention to ensure that messages are mutually understood.

Minority Veterans Are More Willing to Participate in Complex Studies Compared to Non-minorities

Several states have mandated that, after mammography, patients be informed if their breasts are dense. Explaining what this means is a challenge.

Glycaemic indices and haemoglobin A1c as predictors for non-healing ulcers

BackgroundMinorities are an underrepresented population in clinical trials. A potential explanation for this underrepresentation could be lack of willingness to participate. The aim of our study was to evaluate willingness to participate in different hypothetical clinical research scenarios and to evaluate the role that predictors (e.g. health literacy) could have on the willingness of minorities to participate in clinical research studies.MethodsWe conducted a mixed-methods study at the Miami VA Healthcare system and included primary care patients with hypertension. We measured willingness to participate as a survey of four clinical research scenarios that evaluated common study designs encountered in clinical research and that differed in degree of complexity. Our qualitative portion included comments about the scenarios.ResultsWe included 123 patients with hypertension in our study. Of the entire sample, ninety-three patients were minorities. Seventy per cent of the minorities were willing to participate, compared to 60 per cent of the non-minorities. The odds ratio (OR) of willingness to participate in simple studies was 0.58; 95 per cent CI 0.18–1.88 p=0.37 and the OR of willingness to participate in complex studies was 5.8; 95 per cent CI 1.10–1.31 p=0.03. In complex studies, minorities with low health literacy cited obtaining benefits (47 per cent) as the most common reason to be willing to participate. Minorities who were not willing to participate, cited fear of unintended outcomes as the main reason.ConclusionsMinorities were more likely to be willing to participate in complex studies compared to non-minorities. Low health literacy and therapeutic misconception are important mediators when considering willingness to participate in clinical research.

Sailing on the '7 Cs': Teaching junior doctors how to redirect patients during difficult consultations in primary care

OBJECTIVE Non-healing lower extremity ulcers (NHLU) are a common podiatric complication of diabetes, with poor glycaemic control as a risk factor for development. Glycaemic indices, such as haemoglobin A1c (HbA1c) and fasting plasma glucose (FPG), are used to diagnose and to monitor diabetes. Using a population-based, nationally representative sample, we evaluate the relationship between glycaemic indices and NHLU (as defined by the patient) to propose glycaemic thresholds for clinical suspicion of patient NHLU status. METHOD Using data from the 1999-2004 National Health and Nutrition Examination Surveys (NHANES), a total of 9769 adults (≥40 years old) with available self-reported diabetes and NHLU status were analysed. Glycaemic index markers, including FPG and HbA1c, were assessed via laboratory analysis from serum blood samples. Logistic regression models were fitted to determine optimal thresholds for FPG and HbA1c to predict NHLU status. RESULTS Compared with those without NHLU, NHLU patients were older, male, had higher rates of diabetes, were more likely to take insulin, and had lower total cholesterol. Youdens Index for NHLU identified the optimal FPG threshold as 117.7mg/dl (sensitivity: 33.5%; specificity: 82.6%). The optimal HbA1c threshold was 5.9% (sensitivity: 43.2%; specificity: 77.3%). HbA1c (Odds ratio (OR) 2.44, 95% Confidence Interval (CI) 1.96-3.05; Area under curve (AUC) 0.62) was a stronger discriminator of NHLU compared to FPG (OR 2.19; 95%CI 1.57-3.05; AUC 0.60). CONCLUSION This study identified glycaemic thresholds for suspicion of NHLU development that are lower than the glucose goal levels recommended as optimal by the American Diabetes Association. Health professionals should be aware of these glycaemic indices when screening patients with diabetes for NHLU. Future longitudinal and validation studies are necessary to better discern the ideal glycaemic index thresholds to identify NHLU.