How are we communicating about clinical trials?

CONCLI-01023; No of Pages 9 Contemporary Clinical Trials xxx (2014) xxx–xxx

Contents lists available at ScienceDirect

Contemporary Clinical Trials

3Q1 4 5Q2 6 7 8Q3 9

R O O

2

How are we communicating about clinical trials? An assessment of the content and readability of recruitment resources Daniela B. Friedman a,b,⁎, Sei-Hill Kim c, Andrea Tanner c, Caroline D. Bergeron a, Caroline Foster d, Kevin General e a b c d e

Department of Health Promotion, Education, and Behavior, University of South Carolina Statewide Cancer Prevention and Control Program, University of South Carolina School of Journalism and Mass Communications, University of South Carolina Department of Communication, College of Charleston Arnold School of Public Health, University of South Carolina

P

1

F

journal homepage: www.elsevier.com/locate/conclintrial

14 19 15 20 16 21 17 22 18 23 24 40 25 41 26 42 27 43 28 44 29 45 30 46 31 32 33 34 35 36 37 38 39 48 47

Article history: Received 5 March 2014 Received in revised form 1 May 2014 Accepted 5 May 2014 Available online xxxx

a b s t r a c t

E

i n f o

Clinical trials (CTs) are important for advancing public health and medical research, however, CT recruitment is challenging. The high reading level of CT information and the technical language of providers or researchers can serve as barriers to recruitment. Prior studies on the informed consent process found that consent documents often contain complicated terms. Limited research has examined resources specifically used to recruit individuals into CTs. The purpose of this study was to examine the content and readability of CT recruitment education resources in one U.S. state. Convenience sampling was employed for the collection of CT recruitment materials. A codebook was developed based on previous content analyses and emergent themes from statewide focus groups about CTs. A total of 127 materials were collected and analyzed (37.8% print; 62.2% Web). Most content was focused on treatment-related CTs (60.6%). Inclusion criteria related to specific disease conditions (88.9%) and age (73.6%) were described most often. Only 30% of resources had an explicit call to action. Overall mean readability level was Grade 11.7. Web-based materials were significantly more likely to be written at a higher grade level than print materials (p ≤ .0001). Readability also differed significantly according to resource distributor/creator, CT type, person quoted, and presence or absence of inclusion criteria and an explicit call to action. Our study provides insight into the content and difficulty level of recruitment materials intended to provide initial information about a CT. Future studies should examine individuals’ comprehension of recruitment materials and how participation intentions are associated with recruitment messages. © 2014 Elsevier Inc. All rights reserved.

T

a r t i c l e

C

12 13

N C

O

R

R

E

Keywords: Clinical trials Recruitment Education materials Print Internet Reading level

49

1. Introduction

51

Clinical trials (CTs) research is considered critical for advancing health and medical research, however, CT recruitment continues to be challenging [35,36,80], especially among

U

50

52 53

D

10

⁎ Corresponding author at: Department of Health Promotion, Education, and Behavior, & Cancer Prevention and Control Program, University of South Carolina, Arnold School of Public Health, 915 Greene Street, Suite 235. Tel.: +1 803 576 5641; fax: +1 803 576 5624. E-mail address: [email protected] (D.B. Friedman).

minority and underserved populations [17,18,34]. Barriers to CT participation have been studied extensively and include patients' limited awareness of CTs, misperceptions, distrust of doctors and researchers, and fear of CTs and general medical research [19,33,34,45,55,60]. Healthcare providers may also contribute to low enrollment in trials because of limited awareness about CTs or lack of communication with patients about CTs [4,8,55]. Furthermore, the technical language that physicians and/or researchers use [63] and the difficulty level of CT education resources

http://dx.doi.org/10.1016/j.cct.2014.05.004 1551-7144/© 2014 Elsevier Inc. All rights reserved.

Please cite this article as: Friedman DB, et al, How are we communicating about clinical trials?, Contemp Clin Trials (2014), http:// dx.doi.org/10.1016/j.cct.2014.05.004

54 55 56 57 58 59 60 61 62 63

81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101

2. Materials and methods

103

2.1. Selection of materials

104 105

Convenience sampling was employed for this content analysis of CT recruitment resources [38]. In March 2013 we contacted CT research staff from all five major academic medical centers in a southeastern U.S. state to request copies of their CT recruitment and promotional materials. These centers are all affiliates of a statewide biomedical research collaborative committed to transforming the state's public health and economic well-being through research. We requested their CT materials from the past five to 10 years. Format of the recruitment and education materials could include Web pages (links were requested), electronic or hard copy newsletters, hospital public relations magazines, posters, flyers, and videos. Materials were mailed or emailed or picked up in person by project coordinators between March and May 2013. We also searched for relevant information resources on the websites (specifically a CT-focused webpage per website) of the five centers.

110 111 112 113 114 115 116 117 118 119 120

N

U

108 109

C

102

106 107

2.3. Analytic approach

168

All materials were coded using IBM SPSS version 21.0 (http://www-01.ibm.com/support/docview.wss?uid= swg21608060). Descriptive statistics and nonparametric frequencies and chi-squares were calculated. P values ≤ .05 were considered significant. The Simple Measure of Gobbledygook (SMOG) formula, an accurate and convenient tool for assessing health education materials, was used to assess the reading grade level (i.e., readability) of the CT resources [22]. SMOG, designed to predict readability based on total number of polysyllabic words, correlates extremely well

169

O

F

122 123

R O

79 80

A comprehensive codebook was developed based on previous content analysis methodology [27,52,68,79,82] and key concepts that emerged from statewide, community-based focus groups about CT perceptions and knowledge [19,20]. The schema for this analysis covered six domains – source (resource distributor), format (print, Web), design and images (population depicted, data tables, etc.), content (CT inclusion criteria and target audience, study details, CT type, contact information, etc.), frames (gain, loss) [83], and readability level (SMOG test) [22,29,53,56]. All variables coded are important to consider in the development of health communication resources to ensure that they are appropriate for their intended audiences. Source was examined in order to assess whether the information was from a reputable agency or organization [77,78]. Format was assessed to examine how CT recruitment information was being communicated by the medical centers. Design factors and visuals/images were examined for cultural appropriateness and appeal for the specified target audiences (e.g., racial/ethnic groups or age groups; [41,47,73]). Content was assessed to capture the volume and scope of information provided in CT educational materials. Framing refers to the process where specific aspects of reality are made more salient within text to promote a specific issue or recommendation, while leaving other aspects in the background [14]. The most common health-related frames are gain frames (i.e., benefits/opportunities) and loss frames (i.e., negative consequences; [59,69]). Frames were examined to see which strategy was most commonly used in CT recruitment materials to encourage individuals to participate [5,13,51]. Readability was analyzed to assess whether materials were written at appropriate reading levels for the intended participants [3,25]. Table 1 provides a listing of the main variables coded and their corresponding definitions. To ensure coding agreement, two members of the research team independently coded randomly selected materials (n = 29 or 20% of the total sample) and inter-rater reliability was calculated. Cohen's Kappa [28,50,70,74,77,78] was calculated for 75 variables (see Table 1). The mean percent agreement between the two coders was 92.0%. The average Kappa score was .781 (range: .202–1.000), indicating ‘substantial’ or ‘good’ nearing ‘very good’ coding agreement [28,74]. Coders reached 100% coding agreement after discussing discrepant codes. Modifications to the codebook were made based upon the results of this coding activity and the finalized schema was reviewed and approved by all authors.

P

77 78

121

D

75 76

2.2. Coding

T

73 74

C

71 72

E

69 70

R

68

R

66 67

provided to patients [81] can serve as barriers to recruitment and enrollment. Providers often overestimate their patients' health literacy skills [9] and the clarity of their own communication [42]. Poor health literacy and limited patient-provider communication are associated with poor health outcomes [7,16,71,85,86]. Use of jargon-free language is recommended for all health-related content [72]. It is recommended that health and medical resources and consent forms intended for the public use plain language (~ written at grade 5–6 level) to improve participant understanding and satisfaction [44,57,58]. CT-related documents (e.g., informed consent forms, education materials) are typically written in technical language. Studies examining the readability of consent forms show resources are written at an upper high school (Grades 11–12; students ages 16–18) to college level (Grade 13 +; students ages18 and older), exceeding the average literacy level of the general population [61,64,65,81]. Another study by Fagerlin, Royner, Stableford, Jentoft, Wei and Holmes-Rovner [15] that examined the readability of educational materials about prostate cancer CTs also reported reading levels above the ninth grade level. Participants with greater comprehension of CTs are more likely to perceive research procedures (e.g., use of placebos) to be more acceptable compared to individuals who may not understand these terms [10]. Most studies of CT perceptions and comprehension have been conducted on the informed consent process and documents. Research has not examined the resources developed to recruit individuals into a research study (e.g., CTs). These materials (e.g., flyers, posters) may be the first documentation that individuals receive about a CT, which can influence their knowledge, attitudes, and understanding about CTs [49,76,88]. Ultimately, these recruitment materials can impact individuals' decisions to follow up with researchers for more information or sign up if they qualify. For this reason, the purpose of this research was to examine the content and readability of CT recruitment resources in one U.S. state.

O

64 65

D.B. Friedman et al. / Contemporary Clinical Trials xxx (2014) xxx–xxx

E

2

Please cite this article as: Friedman DB, et al, How are we communicating about clinical trials?, Contemp Clin Trials (2014), http:// dx.doi.org/10.1016/j.cct.2014.05.004

124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167

170 171 172 173 174 175 176 177 178

D.B. Friedman et al. / Contemporary Clinical Trials xxx (2014) xxx–xxx

197

3.1. Overview of recruitment materials

198

Four of the five academic medical centers provided printed CT resources. We searched for and included relevant Web resources from all five centers' main websites. A total of 127 materials were collected and analyzed. Of these, 37.8% were print and 62.2% were Web-based resources. Of the print materials, the majority were flyers (35.4%) and brochures (25.0%) followed by cards such as postcards (14.6%), education guides or pamphlets (12.5%), and print-outs of PowerPoint presentation slides (10.4%) or email messages (2.1%). For Web-based resources, it took an average of two clicks (range: 1–5) to reach the specific webpage within the site that contained CT information. The distributors (creators) of most resources were universities (42.5%) and hospitals (33.9%), followed by government (17.3%) and industry such as pharmaceutical companies (6.3%). Government and pharmaceutical materials were significantly more likely to be Web than print resources (Web: government: n = 21/22 or 95.5%; pharmaceutical: n = 8/8 or 100%; X2(df = 3) = 20.134, p ≤ .0001). Hospitals and universities provided both printed and online resources (hospitals: n = 22/43 or 51.2% print, n = 21/43 or 48.8% Web; universities: n = 25/54 or 46.3% Web, n = 29/ 54 or 53.7% Web). Over two-thirds (67.7%) of resources included the CT organization's logo, however less than one-third (32.3%) described whether the CT was approved by an institutional review board (IRB). No significant differences in IRB mention according to resource distributor type were found. The majority of resources contained a combination of text and photographs (n = 69 or 54.3%). Within these 69 resources, the populations depicted were mainly Caucasians (62.3%) followed by African Americans (40.6%). Few images (4.3%) were of Latino groups. Images on the recruitment materials were typically of adults ages 18 to 64 (63.8%). Fewer materials portrayed younger adults under 18 (17.3%) or older individuals ~ 65 + (11.6%). Overall, very few recruitment education materials presented disease risk data – whether in the form of a table or chart (8.7%) or percentages or frequencies within the text or narrative

204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236

3.2. Content of recruitment materials

239

CT materials varied in the volume and scope of information provided. Nearly 60% of resources (59.1%) clearly stated which organization was conducting the CT. Most (81.9%) mentioned a specific disease. Of the 104 resources that discussed a disease, many were about specific trials related to mental health (37.5%), cancer (36.5%), or cardiovascular disease (18.3%). With respect to CT type, overall most content was focused on treatment-related trials (60.6%) followed by quality of life (15.7%), prevention (11.0%), diagnosis (9.4%), and screening (8.7%). About 42% of materials described a new, ‘breakthrough’ treatment. About 45% of resources mentioned a specific CT. Of those mentioning a specific trial, 77.2% indicated they were state-specific trials; 22.8% were national trials. Slightly over half of all materials (56.7%) presented CT inclusion criteria. More print (n = 39/48 or 81.3%) than Web (n = 33/79 or 41.8%) materials offered inclusion criteria (X2(df = 1) = 18.953, p ≤ .0001). Inclusion criteria related to age (73.6%) and specific disease (88.9%) were described most often. Fewer resources mentioned inclusion based on a person's specific symptoms (23.6%), gender (9.7%) or race/ ethnicity (2.8%). Just under 30% of resources described the time commitment that would be involved with trial participation. Participant incentives were listed on few materials. They included: money (20.5%), medication (11.0%), ‘free’ healthcare (9.4%), and transportation vouchers (7.1%). The resources primarily targeted consumers or patients (77.2%); some materials had content for physicians or CT investigators (22.8%) that described CT recruitment strategies. Of the 98 materials targeting only consumers or patients, most were intended for patients (76.5%), general public (30.6%), families (13.3%), or older adults (5.1%). Quotes from experts such as physicians or medical researchers were provided on few materials (2.4%) as were quotes from lay people such as former CT participants or individuals at risk for a particular disease (4.7%). The majority of resources (64.6%) included a telephone number for people to call and learn more about the trial(s) being described. Only 20.5% included an email address. A contact person was listed on about one-third of the resources (33.9%). Less than half of the print resources (43.8%) included a website for people to seek additional information about the trial(s) being described. Only 30% of resources had an explicit call to action (e.g., ‘Call now to find out if you are eligible.’) that accompanied the contact information provided. Content was framed in a variety of ways. A number of resources focused on a societal gain frame (e.g., that CTs provided benefits to society by advancing science) (40.2%). Other content mentioned an individual gain frame, including that CTs provided benefits to individuals, in general, by providing improved medical care (32.3%), or a personal gain frame (e.g., If you participate your health will be improved; 18.1%). Content less often contained a personal loss frame (e.g., If you do not participate, you will miss out on trial benefits; 4.7%). One Web-based resource had content pertaining to all

240

D

E

203

C

201 202

E

199 200

R

192 193

R

190 191

O

188 189

N C

186 187

U

184 185

F

3. Results

183

R O O

196

181 182

(24.4%). No differences in presentation of data were found 237 by resource format. 238

P

194 195

with other readability instruments and has shown to have high inter-rater reliability [46]. As per the published instructions for using SMOG, scores were calculated manually for up to 30 sentences on all of the materials [56]. If resources had more than 30 sentences, 10 sentences each from the introduction, middle, and conclusion sections of print or Web-based materials were selected for analysis. If the material contained less than 30 sentences, all text was analyzed. Subheadings were not tested for readability unless materials contained ‘FAQs’ (Frequently Asked Questions) [22]. We examined readability level by resource characteristics such as format (print vs. Web) and distributor (government, university, hospital, pharmaceutical), and tested the significance of differences between resource characteristics, using nonparametric rank sum tests (e.g. Mann–Whitney U and Kruskal–Wallis). These types of analyses have been used in other literacy-focused content analysis research [24–26,30].

T

179 180

3

Please cite this article as: Friedman DB, et al, How are we communicating about clinical trials?, Contemp Clin Trials (2014), http:// dx.doi.org/10.1016/j.cct.2014.05.004

241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294

4 t1:1 t1:2

D.B. Friedman et al. / Contemporary Clinical Trials xxx (2014) xxx–xxx

Table 1 Main topic domains, codes, and inter-rater reliability.

t1:3

Topic Domain

t1:4 t1:5 t1:6 t1:7 t1:8 t1:9 t1:10 t1:11 t1:12 t1:13 t1:14 t1:15 t1:16 t1:17 t1:18 t1:19 t1:20 t1:21 t1:22 t1:23 t1:24 t1:25 t1:26 t1:27 t1:28 t1:29 t1:30 t1:31 t1:32 t1:33 t1:34 t1:35 t1:36 t1:37 t1:38 t1:39 t1:40 t1:41 t1:42 t1:43 t1:44 t1:45 t1:46

Distributor – organization distributing material (hospital, pharmaceutical, university, government) Print versus Web Type of printed material – flyer, poster, card, brochure (1 – 4 pages), pamphlet/guide (5+ pages), PowerPoint/Email printout Design/Images Photographs – yes/no Illustrations – yes/no Race/Ethnicity depicted in images African American – yes/no White – yes/no Latino – yes/no Asian – yes/no Other – yes/no Ages depicted in images b18 years old – yes/no Adults (18 – 64 years) – yes/no Older adults (65+ years) – yes/no Data table/chart – yes/no Statistics – percentages describing disease risk – yes/no Organization logo – yes/no Website clicks – number of clicks to the first page of CT information for Web-based resources (number) Content Mobilizing information – contact information leading audience to additional information Website link – yes/no Telephone number – yes/no Email address – yes/no Contact person – yes/no Inclusion criteria – pertaining to CT eligibility – yes/no Age – yes/no Race – yes/no Gender – yes/no Disease-specific – yes/no Symptom-specific – yes/no Time commitment – how much time involved in CT participation – yes/no Disease mention – whether trial(s) discussed is about specific disease (categories of conditions based on resources received) Cardiovascular disease – yes/no Cancer – yes/no Mental illness – yes/no Reproductive health – yes/no Smoking – yes/no Drug addiction – yes/no Weight management – yes/no Diabetes – yes/no Other – yes/no Testing new medication/therapy – yes/no Incentives – mention of benefits that CT participants would receive

t1:68 t1:69 t1:70

Cohen's Kappa score 1.00 1.00 .86 .93 .73 .94 .88 .93 .87 1.00

F

O

R O

P

D

E

T

C

E

R

R

O

Money – yes/no Medication – yes/no “Free” care – yes/no Transportation vouchers – yes/no Call to action – whether resource explicitly asks people to take action and call a number or go to a website – yes/no IRB – whether resource states that CT has been approved by an institutional review board – yes/no CT description – whether trials described generally or if recruiting for specific trial – general/specific CT category – refers to type of trial (as categorized by clinicaltrials.gov) Prevention – yes/no Screening – yes/no Diagnosis – yes/no Treatment – yes/no Quality of life – yes/no CT location – refers to whether CT offered nationally or state/region specific Target audience – refers to whether resource explicitly indicates for whom resource is intended – yes/no

U

N

C

t1:47 t1:48 t1:49 t1:50 t1:51 t1:52 t1:53 t1:54 t1:55 t1:56 t1:57 t1:58 t1:59 t1:60 t1:61 t1:63 t1:64 t1:65 t1:66 t1:67

Code and description

Source Format

Frames

Readability

Quotes From experts (e.g., physicians/researchers) – yes/no From laypersons (e.g., former CT participants) – yes/no Gain (e.g., if you participate in a CT, your health will improve) – yes/no Loss (e.g., if you do not participate in a CT, you will miss out on care) – yes/no Advances in science (e.g., benefits to society) – yes/no Improved medical care (e.g., benefits to individual) – yes/no SMOG grade level calculated

.94 .82 .94 1.00 .65 .84 1.00 1.00 .85 .79 .86 1.00 1.00 .93 1.00 .76 .71 .83 .77 .79 .93 .79 1.00 1.00 1.00 .65 .86 .79 1.00 .45 .71 1.00 .47 .66 1.00 .65 .78 .69 .65 .25 .71 .65 .46

.73 1.00 .73 .45 .46

Please cite this article as: Friedman DB, et al, How are we communicating about clinical trials?, Contemp Clin Trials (2014), http:// dx.doi.org/10.1016/j.cct.2014.05.004

t1:62

D.B. Friedman et al. / Contemporary Clinical Trials xxx (2014) xxx–xxx

4. Discussion

336 337

This is the first study to assess the content and readability of a sample of CT recruitment materials (N = 127) provided by five large academic medical centers in one southeastern U.S. state. Typically, research on the readability and comprehension of CT information has focused on informed consent documents [57,61,62,65,81]. Our study provides important insight into the content and difficulty level of recruitment education materials that are intended to provide initial information about a research study, promote awareness, and encourage individuals or families to enroll. Interestingly, medical centers interpreted CT recruitment materials as encompassing resources describing recruitment practices. We thought it was important to present these resources in our analysis and provide a description of the full collection of materials provided to us by these centers.

313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332

338 339 340 341 342 343 344 345 346 347 348 349 350

E

311 312

R

309 310

R

308

O

306 307

N C

304 305

U

302 303

R O O

335

300 301

P

333 334

The overall mean SMOG readability level was Grade 11.7 ± 2.3 (Range: Grade 7–16; 95% CI: 11.3–12.1), indicating that an upper high school education would be required to read and understand these CT recruitment materials. Web-based materials were significantly more likely to be written at a higher grade level compared to print materials (U = 1123.500, p ≤ .0001). Readability also differed significantly by distributor (X2(df = 3) = 10.737, p = .013) with the most technical language included in materials from hospitals followed by those from pharmaceutical companies, government, and university. A pairwise comparison showed a significant difference between the government and pharmaceutical materials (U = 42.500, p = .031). Regarding CT category, materials with diagnosis information were written at the highest grade level followed by screening, prevention, treatment, and quality of life. Materials with quotes from experts had a slightly lower readability than those with layperson quotes (Grade 11.7 ± 1.2, 95% CI = 8.8–14.5 versus Grade 12.2 ± 1.6, 95% CI = 10.5–13.9, not significant). Materials with inclusion criteria were written at a significantly lower readability level compared with materials that did not provide trial criteria details (U = 1524.500, p = .025). While still written at an upper high school level, materials with a call to action were at a lower readability level than those without this directive (U = 1247.000, p = .018). Materials also intended for physicians or CT investigators on best recruitment practices were at a significantly higher readability level than those for patients/consumers (U = 906.500, p = .003). Readability levels did not differ significantly between materials with or without photographs or illustrations or between materials that included or did not include numeric risk information. Materials discussing the benefit of CTs as advancing medical science (i.e., societal gain frame) were written at a higher readability level compared with materials reflecting other frames (not significant). Table 2 presents readability results.

D

298 299

E

3.3. Readability of recruitment materials

C

297

The majority of resources described treatment-related trials. Few CT recruitment materials were from pharmaceutical companies. This may be because the materials collected and analyzed were from academic medical institutions conducting their own trials. Surprisingly, less than one-third of resources mentioned whether the CT being described was approved by an IRB. Post-hoc analysis revealed no differences in mention of IRB according to target audience of the materials or according to resource format (i.e., print versus Web). Materials that portrayed images of ethnic/racial minority groups or made mention of race as an inclusion criteria were limited. If investigators are intending to recruit minorities into research studies, more culturally appropriate strategies (e.g., relevant images; reflections of historic and cultural beliefs, values, norms) will be needed so communities understand that they are eligible to participate [21,40,48,66]. On the other hand, investigators may not have been intending to recruit only minority groups in research, thus, they did not stress this race/ethnicity as a criterion on the recruitment materials. Regardless, even if a trial is not specifically targeting a particular racial/ethnic group, samples should generally be broad (unless clinically indicated) to maximize representation in the trial. Furthermore, without clinical research with racial/ethnic populations, the evidence upon which health and medical recommendations are based will be made without the participation of minority groups. For example, while African Americans are at significantly higher cancer risk, they also have low rates of participation in health and cancer research, particularly in clinical trials [6,32,39,67,84] and recent screening recommendations are based on studies with few to no African Americans [2]. Limited resources described whether or not individuals would receive an incentive for participating in the CT. Focus group research conducted in the state where these materials were collected revealed that incentives, particularly financial incentives, often are what motivates people to pay attention to information about CTs and encourages them to enroll and participate in research [20,60]. However, if researchers thought that including the incentive amount on recruitment materials could be viewed as coercive, then they may have only included this detail on the participant information letter and consent form and not on recruitment flyers and posters. Furthermore, Institutional Review Boards (IRBs) and Human Research Ethics Committees moderate the specific information that is included on CT recruitment materials, particularly related to sensitive topics, thus this may not have been an omission by the researchers. While the majority of resources provided a telephone number for further information, few provided other mobilizing information such as an email address, website link, or a contact name. Explicit calls to action such as “visit this website to enroll” or “call this number to find out more” were also rarely included on recruitment documents. Without this type of directive that mobilizes people to act on their pre-existing attitudes, potential study participants may not take any action regarding the information (e.g., telephone number, website, etc.) presented to them [30,77–79]. The overall mean SMOG readability score was high at Grade 11.73. This finding is consistent with other research on the readability of health education materials [24–26,29]. Materials developed by hospitals were written at higher

F

frames. Remaining articles (5.5%) did not have an explicit frame.

T

295 296

5

Please cite this article as: Friedman DB, et al, How are we communicating about clinical trials?, Contemp Clin Trials (2014), http:// dx.doi.org/10.1016/j.cct.2014.05.004

351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 401 402 403 404 405 406 407 408 409 410 411

6

Table 2 SMOG readability grade level by CT recruitment material characteristics.

t2:3

419 420 421 422 423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 439

12.4 11.6 10.6 12.4

11.8–13.0 10.9–12.2 9.6–11.5 11.0–13.7

Trial type Prevention Screening Diagnosis Treatment Quality of life

11.6 11.9 12.1 11.5 11.4

Quotes Experts Laypersons

11.7 12.2

Inclusion criteria Yes No

11.3 12.4

E

R

grade levels than those from pharmaceutical companies, government, or universities. Other research indicates difficult readability levels of resources distributed in hospital settings [31,87]. Recruitment materials focused on diagnostic-related trials were most technical followed by those on screening, prevention, treatment, and quality life. Given that the majority of trials were treatment trials, it may be that investigators or recruitment managers charged with creating recruiting materials have limited experience writing plain language promotional materials on other types of trials. In addition, content requirements made by IRBs may result in recruitment materials with technical language that is not understood completely by individuals with lower literacy. While it is encouraging that resources that described CT inclusion criteria and presented an explicit ‘call to action’ statement were written at a lower level than those lacking these items, these materials were still written at an upper high school level and may not be understood by the average reader [22,58]. Results from this study found no significant differences in readability level between materials with or without photographs or illustrations. Typically inclusion of images such as photographs, illustrations, and visual aids (e.g., tables or flowcharts) can help improve readability and are recommended for health education resources [11,22,41]. Finally, the most common frame identified was that of advancement of science being a benefit to CT participation. Resources with this frame were also written at the most technical reading level. While this may be an important

O R O

8.8–14.5 10.5–2.4

10.8–11.7 11.7–13.0

D C

T

Frame Personal gain Personal loss Societal gain (advances in science) Individual gain (improved medical care)

10.3–13.0 10.3–13.6 10.4–13.8 11.0–12.0 10.3–12.5

11.1 12.0

10.4–11.8 11.5–12.5

11.2 10.5 12.3 12.0

10.3–12.1 8.3–12.7 11.7–12.9 11.3–12.7

E

Call to action Yes No

F

Distributor Hospital University Government Industry/pharmaceutical

R

417 418

10.1–11.3 11.9–12.9

O

415 416

10.7 12.4

C

413 414

95% CI

N

412

Grade Format Print Web

U

t2:4 t2:5 t2:6 t2:7 t2:8 t2:9 t2:10 t2:11 t2:12 t2:13 t2:14 t2:15 t2:16 t2:17 t2:18 t2:19 t2:20 t2:21 t2:22 t2:23 t2:24 t2:25 t2:26 t2:27 t2:28 t2:29 t2:30 t2:31 t2:32 t2:33 t2:34 t2:35 t2:36 t2:37

P

t2:1 t2:2

D.B. Friedman et al. / Contemporary Clinical Trials xxx (2014) xxx–xxx

benefit of CT participation, researchers need to describe this information in plain language and perhaps include tangible benefits that may resonate more strongly with potential participants. Previous research suggests that there may be a disconnect between CT investigators' perceptions of effective recruitment strategies and what actually would encourage individuals to participate in CTs [80]. For example, communities have expressed that the personal benefit to themselves and/or their families is a motivator to participation in research [20,60]. Guided by principles of plain language, health communication, and health literacy ([12,22]; Friedman et al., 2007; [41,58,66,72,77,78,83]), we recommend that researchers consider the following when developing CT recruitment resources:

440

1. Specify that CT was approved by an IRB to establish trust with potential participants; 2. Present a combination of text and images to enhance readability and draw in the target population; 3. Promote CTs using both print and Web-based resources if/ as appropriate in order to extend the reach of CT materials for the target population; 4. Include relevant and culturally appropriate visuals of the population (i.e., gender, age, race/ethnicity) being recruited for the specific trial; 5. If/as permitted by IRB, specify CT inclusion criteria and participant incentives;

455 456

Please cite this article as: Friedman DB, et al, How are we communicating about clinical trials?, Contemp Clin Trials (2014), http:// dx.doi.org/10.1016/j.cct.2014.05.004

441 442 443 444 445 446 447 448 449 450 451 Q4 452 453 454

457 458 459 460 461 462 463 464 465 466

D.B. Friedman et al. / Contemporary Clinical Trials xxx (2014) xxx–xxx

492 493 494 495 496 497 498 499 500 501 502 503 504 505 506 507 508 509 510 511 512 513 514 515 516 517 518 519 520 521 522 523 524 525

E

490 491

R

488 489

R

486 487

O

484 485

N C

528 529

531

[1,43,54]

F

478 479

U

476 477

530 Q5

References

R O O

This study had limitations. First, we analyzed a convenience sample of CT recruitment materials of varying focus, lengths, and format available from five academic medical centers in the state and our findings are limited in terms of generalizability. Additional recruitment resources may have been available from physician practices and researchers unaffiliated with these centers. However, we feel that focusing our study on these centers allowed us to collect information about key CTs in the state that may have also been promoted through other practices and venues. Second, while the inter-rater reliability coding scores were mainly high and considered ‘very good’ to ‘excellent,’ we did not reach recommended scores for some variables. We feel confident, however, about our accurate coding given that coders reached 100% agreement after discussing discrepant codes. Third, we recognize limitations of readability instruments such as SMOG that calculate difficulty level of information based on number of syllables and sentences. Although readability can play a role in people's understanding of health information, other factors such as images/diagrams, prior knowledge, specific content, and relevance are important for comprehension [23] and participation in research [37]. A recent review article examining studies for which a change to informed consent documents was made to accommodate individuals with lower literacy (b8th grade level) found that studies using a ‘teach-back’ method (i.e., repeating health/medical instructions back to a provider to ensure understanding) resulted in better patient comprehension compared with studies that simply lowered reading grade level of documents [75]. Despite these limitations, this study is the first comprehensive assessment of the content and readability of CT materials focused on recruitment and it provides details about how these materials can be improved. While this research is focused on resources collected within one state, the description of our systematic content analysis methods and findings will also be useful to other researchers interested in examining CT recruitment materials available in various settings for diverse populations. Future studies should examine the content and readability of recruitment ads and resources available through other outlets such as the mass media, individuals' comprehension of recruitment

474 475

6. Uncited references

[1] Amalraj S, Starkweather C, Nguyen C, Naeim A. Health literacy, communication, and treatment decision-making in older cancer patients. Oncology (Williston Park) 2009;23(4):369–75. [2] Andriole GL, Crawford ED, Grubb III RL, Buys SS, Chia D, Church TR, et al. Mortality results from a randomized prostate-cancer screening trial. N Engl J Med 2009;360(13):1310–9. http://dx.doi.org/10.1056/NEJMoa0810696. [3] Badarudeen S, Sabharwal S. Assessing readability of patient education materials: current role in orthopaedics. Clin Orthop Relat Res 2010;468(10):2572–80. [4] Bergeron CD, Foster C, Friedman DB, Tanner A, Kim S-H. Current state of clinical trials recruitment in rural South Carolina: a comparison of investigators' perceptions and potential participant eligibility. Rural Remote Health 2013;13(4):2567. [5] Bower P, King M, Nazareth I, Lampe F, Sibbald B. Patient preferences in randomised controlled trials: conceptual framework and implications for research. Soc Sci Med 2005;61(3):685–95. [6] Branson RD, Davis Jr K, Butler KL. African Americans' participation in clinical research: importance, barriers, and solutions. Am J Surg 2007;193(1):32–9. http://dx.doi.org/10.1016/j.amjsurg.2005.11.007 [discussion 40]. [7] Caplan L, Wolfe F, Michaud K, Quinzanos I, Hirsh JM. Health literacy is strongly associated with functional status among rheumatoid arthritis patients: A cross-sectional study. Arthritis Care Res (Hoboken) 2013. http://dx.doi.org/10.1002/acr.22165. [8] Castel P, Negrier S, Boissel JP, Plateforme d'Aide à la Recherche Clinique en Cancérologie de la région, Rhone-Alpes. Why don't cancer patients enter clinical trials? A review. Eur J Cancer 2006;42(12):1744–8. http:// dx.doi.org/10.1016/j.ejca.2005.10.033. [9] Dickens C, Lambert BL, Cromwell T, Piano MR. Nurse overestimation of patients' health literacy. J Health Commun 2013;18(Suppl. 1):62–9. http://dx.doi.org/10.1080/10810730.2013.825670. [10] Doab A, Topp L, Day CA, Dore GJ, Maher L. Clinical trial literacy among injecting drug users in Sydney, Australia: A pilot study. Contemp Clin Trials 2009;30(5):431–5. http://dx.doi.org/10.1016/j.cct.2009.04.002. [11] Doak C, Doak L, Root J. Teaching patients with low literacy skills. Philadelphia, PA: Lippincott; 1996. [12] Dominick GM, Friedman DB, Saunders RP, Hussey J, Watkins KK. Factors associated with physical activity literacy among foster parents. Am J Health Behav 2012;36(2):179–92. [13] Edwards SJ, Lilford RJ, Thornton J, Hewison J. Informed consent for clinical trials: in search of the “best” method. Soc Sci Med 1998;47(11):1825–40. [14] Entman RM. Framing: Toward clarification of a fractured paradigm. J Commun 1993;43(4):51–8. [15] Fagerlin A, Royner D, Stableford S, Jentoft C, Wei JT, Holmes-Rovner M. Patient education materials about the treatment of early-stage prostate cancer: a critical review. Ann Intern Med 2004;140:721–8. [16] Federman AD, Wolf MS, Sofianou A, O'Conor R, Martynenko M, Halm EA, et al. Asthma outcomes Are poor among older adults with Low health literacy. J Asthma 2013. http://dx.doi.org/10.3109/02770903.2013.852202. [17] Ford JG, Howerton MW, Lai GY, Gary TL, Bolen S, Gibbons MC, et al. Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review. Cancer 2008;112(2):228–42. http:// dx.doi.org/10.1002/cncr.23157. [18] Ford ME, Siminoff LA, Pickelsimer E, Mainous AG, Smith DW, Diaz VA, et al. Unequal burden of disease, unequal participation in clinical trials: solutions from African American and Latino community members. Health Soc Work 2013;38(1):29–38. [19] Friedman DB, Bergeron CD, Foster C, Tanner A, Kim SH. What do people really know and think about clinical trials? A comparison of rural and urban communities in the South. J Community Health 2013;38(4):642–51. http:// dx.doi.org/10.1007/s10900-013-9659-z. [20] Friedman DB, Foster C, Bergeron CD, Tanner A, Kim S-H. A qualitative study of recruitment barriers, motivators, and community-based strategies for increasing clinical trials participation among rural and urban populations. Am J Health Promot Mar 26 2014 [Epub].

P

483

472 473

526 527

D

5. Limitations and conclusions

471

materials, and how people's intentions to participate in CTs are associated with recruitment messages. We also suggest a more comprehensive assessment of sponsorship disclosure on CT recruitment and education resources.

E

482

469 470

C

480 481

6. Include an active call to action with contact information (i.e., telephone number, email address, website) to mobilize potential participants to follow up; 7. Conduct formative research (e.g., interviews/focus groups) with the intended population to ensure that potential participants will relate to the content and message frame(s) being used to recruit them for CTs; 8. Attempt to keep content readability at a Grade 5–6 level by including bullet points, short sentences, and avoiding medical jargon. 9. Pilot test all CT recruitment resources with members of the intended population to ensure comprehension. During pilot testing, ask questions to gauge understanding and consider using comprehension tests (e.g., multiple choice tests, teach-back).

T

467 468

7

Please cite this article as: Friedman DB, et al, How are we communicating about clinical trials?, Contemp Clin Trials (2014), http:// dx.doi.org/10.1016/j.cct.2014.05.004

532 533 534 535 536 537 538 539 540 541 542 543 544 545 546 547 548 549 550 551 552 553 554 555 556 557 558 559 560 561 562 563 564 565 566 567 568 569 570 571 572 573 574 575 576 577 578 579 580 581 582 583 584 585 586 587 588 589 590 591 592 593 594 595 596 Q6

D

P

R O

O

F

[44] Jefford M, Moore R. Improvement of informed consent and the quality of consent documents. Lancet Oncol 2008;9(5):485–93. http:// dx.doi.org/10.1016/S1470-2045(08)70128-1. [45] Kim S-H, Tanner A, Friedman DB, Foster C, Bergeron CD. Barriers to clinical trials participation: A comparison of rural and urban communities in South Carolina. J Community Health Dec 6 2014 [Epub]. [46] King MM, Winton ASW, Adkins AD. Assessing the readability of mental health Internet brochures for children and adolescents. J Child Fam Stud 2003;12:91–9. [47] Kreuter MW, Lukwago SN, Bucholtz DC, Clark EM, Sanders-Thompson V. Achieving cultural appropriateness in health promotion programs: targeted and tailored approaches. Health Educ Behav 2003;30(2):133–46. [48] Kreuter MW, Wray RJ. Tailored and targeted health communication: strategies for enhancing information relevance. Am J Health Behav 2003;27(Suppl. 3):S227–32. [49] Kruse AY, Kjaergard LL, Krogsgaard K, Gluud C, Mortensen EL, Gottschau A, et al. A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. Control Clin Trials 2000;21(3):223–40. [50] Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977;33:159–74. [51] Llewellyn-Thomas HA, McGreal MJ, Thiel EC. Cancer patients' decision making and trial-entry preferences: the effects of “framing” information about short-term toxicity and long-term survival. Med Decis Making 1995;15(1):4–12. [52] Lindley LL, Friedman DB, Struble C. Becoming visible: assessing the availability of online sexual health information for lesbians. Health Promot Pract 2012;13(4):472–80. http://dx.doi.org/10.1177/1524839910390314. [53] Luk A, Aslani P. Tools used to evaluate written medicine and health information: document and user perspectives. Health Educ Behav 2011;38(4):389–403. http://dx.doi.org/10.1177/1090198110379576. [54] Mack N, Ramirez CB, Friedland B, Nnko S. Lost in translation: Assessing effectiveness of focus group questioning techniques to develop improved translation of terminology used in HIV prevention clinical trials. PLoS One 2013;8(9):e73799. http://dx.doi.org/10.1371/journal.pone.0073799. [55] McComas KA, Yang Z, Gay GK, Leonard JP, Dannenberg AJ, Dillon H. Individuals' willingness to talk to their doctors about clinical trial enrollment. J Health Commun 2010;15(2):189–204. http://dx.doi.org/ 10.1080/10810730903528058. [56] McLaughlin GH. SMOG grading – a new readability formula. J Read 1969;12:639–46. [57] Meade CD, Howser DM. Consent forms: how to determine and improve their readability. Oncol Nurs Forum 1992;19(10):1523–8. [58] Meade CD, McKinney WP, Barnas GP. Educating patients with limited literacy skills: the effectiveness of printed and videotaped materials about colon cancer. Am J Public Health 1994;84(1):119–21. [59] O'Keefe DJ, Jensen JD. The relative persuasiveness of gain‐framed and loss‐framed messages for encouraging disease detection behaviors: A meta‐analytic review. J Commun 2009;59(2):296–316. [60] Owens OL, Jackson DD, Thomas TL, Friedman DB, Hebert JR. African – American men's and women's perceptions of clinical trials research: Focusing on prostate cancer among a high risk population in the South. J Health Care Poor Underserved 2013;24(4):1784–800. [61] Paasche – Orlow MK, Taylor HA, Brancati FL. Readability standards for informed – consent forms as compared with actual readability. N Engl J Med 2003;348(8):721–6. http://dx.doi.org/10.1056/NEJMsa021212. [62] Pandiya A. Readability and comprehensibility of informed consent forms for clinical trials. Perspect Clin Res 2010;1(3):98–100. [63] Paramasivan S, Huddart R, Hall E, Lewis R, Birtle A, Donovan JL. Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011). Trials 2011;12:78. http://dx.doi.org/ 10.1186/1745-6215-12-78. [64] Philipson SJ, Doyle MA, Gabram SG, Nightingale C, Philipson EH. Informed consent for research: a study to evaluate readability and processability to effect change. J Invest Med 1995;43(5):459–67. [65] Raich PC, Plomer KD, Coyne CA. Literacy, comprehension, and informed consent in clinical research. Cancer Invest 2001;19(4):437–45. [66] Resnicow K, Baranowski T, Ahluwalia JS, Braithwaite RL. Cultural sensitivity in public health: defined and demystified. Ethn Dis 1999;9(1):10–21. [67] Rivers D, August EM, Sehovic I, Lee Green B, Quinn GP. A systematic review of the factors influencing African Americans' participation in cancer clinical trials. Contemp Clin Trials 2013;35(2):13–32. http:// dx.doi.org/10.1016/j.cct.2013.03.007. [68] Rose ID, Friedman DB, Marquez DX, Fernandez K. What are older Latinos told about physical activity and cognition? A content analysis of a top-circulating magazine. J Aging Health 2013;25(7):1143–58. http:// dx.doi.org/10.1177/0898264313494803. [69] Rothman AJ, Salovey P. Shaping perceptions to motivate healthy behavior: the role of message framing. Psychol Bull 1997;121(1):3–19.

N

C

O

R

R

E

C

T

[21] Friedman DB, Hoffman-Goetz L. Assessment of cultural sensitivity of cancer information in ethnic print media. J Health Commun 2006;11(4):425–47. http://dx.doi.org/10.1080/10810730600671920. [22] Friedman DB, Hoffman-Goetz L. A systematic review of readability and comprehension instruments used for print and Web-based cancer information. Health Educ Behav 2006;33(3):352–73. http://dx.doi.org/ 10.1177/1090198105277329. [23] Friedman DB, Hoffman-Goetz L. An exploratory study of older adults' comprehension of printed cancer information: is readability a key factor? J Health Commun 2007;12(5):423–37. http://dx.doi.org/10.1080/ 10810730701438658. [24] Friedman DB, Hoffman-Goetz L, Arocha JF. Readability of cancer information on the internet. J Cancer Educ 2004;19(2):117–22. http:// dx.doi.org/10.1207/s15430154jce1902_13. [25] Friedman DB, Hoffman-Goetz L, Arocha JF. Health literacy and the World Wide Web: comparing the readability of leading incident cancers on the Internet. Med Inform Internet Med 2006;31(1):67–87. http://dx.doi.org/10.1080/14639230600628427. [26] Friedman DB, Kao EK. A comprehensive assessment of the difficulty level and cultural sensitivity of online cancer prevention resources for older minority men. Prev Chronic Dis 2008;5(1):A07. [27] Friedman DB, Laditka JN, Laditka SB, Mathews AE. Cognitive health messages in popular women's and men's magazines, 2006–2007. Prev Chronic Dis 2010;7(2):A32. [28] Friedman DB, Laditka SB, Laditka JN, Price AE. A content analysis of cognitive health promotion in popular magazines. Int J Aging Hum Dev 2011;73(3):253–81. [29] Friedman DB, Tanner A. Reading difficulty level of medical resources on television Web sites: Recommendations for a social practices approach to consumer health literacy. J Consum Health Internet 2007;11(4):43–60. [30] Friedman DB, Tanwar M, Richter JV. Evaluation of online disaster and emergency preparedness resources. Prehosp Disaster Med 2008;23(5):438–46. [31] Gargoum FS, O'Keeffe ST. Readability and content of patient information leaflets for endoscopic procedures. Ir J Med Sci 2013. http://dx.doi.org/ 10.1007/s11845-013-1033-8. [32] Gross CP, Filardo G, Mayne ST, Krumholz HM. The impact of socioeconomic status and race on trial participation for older women with breast cancer. Cancer 2005;103(3):483–91. http://dx.doi.org/ 10.1002/cncr.20792. [33] Guadagnolo BA, Cina K, Helbig P, Molloy K, Reiner M, Cook EF, et al. Medical mistrust and less satisfaction with health care among Native Americans presenting for cancer treatment. J Health Care Poor Underserved 2009;20(1):210–26. http://dx.doi.org/10.1353/hpu.0.0108. [34] Guadagnolo BA, Petereit DG, Helbig P, Koop D, Kussman P, Fox Dunn E, et al. Involving American Indians and medically underserved rural populations in cancer clinical trials. Clin Trials 2009;6(6):610–7. http:// dx.doi.org/10.1177/1740774509348526. [35] Gul RB, Ali PA. Clinical trials: the challenge of recruitment and retention of participants. J Clin Nurs 2010;19(1–2):227–33. http://dx.doi.org/ 10.1111/j.1365-2702.2009.03041.x. [36] Hadidi N, Lindquist R, Treat-Jacobson D, Swanson P. Participant withdrawal: challenges and practical solutions for recruitment and retention in clinical trials. Creat Nurs 2013;19(1):37–41. [37] Hall AE, Sanson-Fisher RW, Lynagh MC, Threlfall T, D'Este CA. Format and readability of an enhanced invitation letter did not affect participation rates in a cancer registry-based study: a randomized controlled trial. J Clin Epidemiol 2013;66(1):85–94. http://dx.doi.org/ 10.1016/j.jclinepi.2012.07.016. [38] Harmon BE, Blake CE, Thrasher JF, Hebert JR. An evaluation of diet and physical activity messaging in African American churches. Health Educ Behav 2013. http://dx.doi.org/10.1177/1090198113507449. [39] Heiney SP, Arp Adams S, Drake BF, Bryant LH, Bridges L, Hebert JR. Successful subject recruitment for a prostate cancer behavioral intervention trial. Clin Trials 2010;7(4):411–7. http://dx.doi.org/ 10.1177/1740774510373491. [40] Hoffman-Goetz L, Friedman DB. A systematic review of culturally sensitive cancer prevention resources for ethnic minorities. Ethn Dis 2006;16(4):971–7. [41] Houts PS, Doak CC, Doak LG, Loscalzo MJ. The role of pictures in improving health communication: a review of research on attention, comprehension, recall, and adherence. Patient Educ Couns 2006;61(2):173–90. http://dx.doi.org/10.1016/j.pec.2005.05.004. [42] Howard T, Jacobson KL, Kripalani S. Doctor talk: physicians' use of clear verbal communication. J Health Commun 2013;18(8):991–1001. http://dx.doi.org/10.1080/10810730.2012.757398. [43] Howerton MW, Gibbons MC, Baffi CR, Gary TL, Lai GY, Bolen S, et al. Provider roles in the recruitment of underrepresented populations to cancer clinical trials. Cancer 2007;109(3):465–76. http://dx.doi.org/ 10.1002/cncr.22436.

U

597 598 599 600 601 602 603 604 605 606 607 608 609 610 611 612 613 614 615 616 617 618 619 620 621 622 623 624 625 626 627 628 629 630 631 632 633 634 635 636 637 638 639 640 641 642 643 644 645 646 647 648 649 650 651 652 653 654 655 656 657 658 659 660 661 662 663 664 665 666 667 668 669 670 671 672 673 674 675 676

D.B. Friedman et al. / Contemporary Clinical Trials xxx (2014) xxx–xxx

E

8

Please cite this article as: Friedman DB, et al, How are we communicating about clinical trials?, Contemp Clin Trials (2014), http:// dx.doi.org/10.1016/j.cct.2014.05.004

677 678 679 680 681 682 Q7 683 684 685 686 687 688 689 690 691 692 693 694 695 696 697 698 699 700 701 702 703 704 705 706 707 708 709 710 711 712 713 714 715 716 717 718 719 720 721 722 723 724 725 726 727 728 729 730 731 732 733 734 735 736 737 738 739 740 741 742 743 744 745 746 747 748 749 750 751 752 753 754 755 756

D.B. Friedman et al. / Contemporary Clinical Trials xxx (2014) xxx–xxx

[80] Tanner A, Kim S-H, Friedman DB, Foster C, Bergeron C. Barriers to medical research participation as perceived by clinical trial investigators: Communicating with rural and African American communities. J Health Commun 2014 [in press]. [81] Taylor HE, Bramley DE. An analysis of the readability of patient information and consent forms used in research studies in anaesthesia in Australia and New Zealand. Anaesth Intensive Care 2012;40(6):995–8. [82] Vandenberg AE, Price AE, Friedman DB, Marchman G, Anderson LA. How do top cable news websites portray cognition as an aging issue? Gerontologist 2012;52(3):367–82. http://dx.doi.org/10.1093/geront/ gnr100. [83] Vanderknyff J, Friedman DB, Tanner A. Framing life and death on YouTube: The strategic communication of organ donation messages by organ procurement organizations. J Health Commun 2014 [in press]. [84] Waters LA, Galichet B, Owen N, Eakin E. Who participates in physical activity intervention trials? J Phys Act Health 2011;8(1):85–103. [85] Westlake C, Sethares K, Davidson P. How can health literacy influence outcomes in heart failure patients? Mechanisms and interventions. Curr Heart Fail Rep 2013;10(3):232–43. http://dx.doi.org/10.1007/ s11897-013-0147-7. [86] Willens DE, Kripalani S, Schildcrout JS, Cawthon C, Wallston K, Mion LC, et al. Association of brief health literacy screening and blood pressure in primary care. J Health Commun 2013;18(Suppl. 1):129–42. http:// dx.doi.org/10.1080/10810730.2013.825663. [87] Wilson FL, Williams BN. Assessing the readability of skin care and pressure ulcer patient education materials. J Wound Ostomy Continence Nurs 2003;30(4):224–30. http://dx.doi.org/10.1067/ mjw.2003.137. [88] Winslow EH. Patient education materials: can patients read them, or are they ending up in the trash? Am J Nurs 2001;101(10):33–8.

P

R O O

F

[70] Rounder D, Slater M, Domenech-Rodriguez M. Adolescent evaluation of gender role and sexual imagery in television advertisements. J Broadcast Electron Media 2003;47:435–54. [71] Sentell T, Zhang W, Davis J, Baker KK, Braun KL. The influence of community and individual health literacy on self-reported health status. J Gen Intern Med 2013. http://dx.doi.org/10.1007/s11606-013-2638-3. [72] Stableford S, Mettger W. Plain language: a strategic response to the health literacy challenge. J Public Health Policy 2007;28(1):71–93. http://dx.doi.org/10.1057/palgrave.jphp.3200102. [73] Steele M, Dow L, Baxter G. Promoting public awareness of the links between lifestyle and cancer: A controlled study of the usability of health information leaflets. Int J Med Inform 2011;80(12):e214–29. [74] Szklo M, Nieto FJ. Epidemiology: Beyond the basics. Boston, MA: Jones and Bartlett; 2004. [75] Tamariz L, Palacio A, Robert M, Marcus EN. Improving the informed consent process for research subjects with low literacy: a systematic review. J Gen Intern Med 2013;28(1):121–6. http://dx.doi.org/10.1007/ s11606-012-2133-2. [76] Tait AR, Voepel-Lewis T, Malviya S, Philipson SJ. Improving the readability and processability of a pediatric informed consent document: effects on parents' understanding. Arch Pediatr Adolesc Med 2005;159(4):347–52. [77] Tanner A, Friedman DB. Authorship and information sourcing for health news on local TV news Web sites: An exploratory analysis. Sci Commun 2011;33(1):3–27. [78] Tanner A, Friedman DB. Health on the Web: An examination of health content and mobilizing information on local TV Web sites. Inform Health Soc Care 2011;36(1):50–61. [79] Tanner A, Friedman DB, Koskan A, Barr D. Disaster communication on the internet: a focus on mobilizing information. J Health Commun 2009;14(8):741–55. http://dx.doi.org/10.1080/10810730903295542.

D

757 758 759 760 761 762 763 764 765 766 767 768 769 770 771 772 773 774 775 776 777 778 779 780 781 782 783 784 785 786 787

9

U

N C

O

R

R

E

C

T

E

820

Please cite this article as: Friedman DB, et al, How are we communicating about clinical trials?, Contemp Clin Trials (2014), http:// dx.doi.org/10.1016/j.cct.2014.05.004

788 Q8 789 790 791 792 793 794 795 796 797 798 799 800 Q9 801 802 803 804 805 806 807 808 809 810 811 812 813 814 815 816 817 818 819