The development of a web- and a print-based decision aid for prostate cancer screening

Prostate cancer (PCa) is the leading cancer diagnosis among men and the second leading cause of male cancer death [1, 2]. While research has shown that PCa screening can find cancer at its earliest stages, it is uncertain whether early detection and treatment of PCa leads to a reduction in disease-related mortality [3, 4]. Preliminary results from two large randomized controlled cancer screening trials (RCTs) have recently been published [5, 6]. While one trial found a 20% reduction in death from PCa as a result of screening [6], findings from the other trial showed no significant reduction in disease-related mortality [5]. Given these inconclusive results, the uncertainties regarding screening continue. The final mortality results from these trials will not be available for several years.

The challenge of making medical decisions prior to the availability of definitive outcome data has been a long-standing issue in cancer screening [7–9] that is likely to become increasingly important as advances in screening technology outpace our ability to validate effectiveness [10–14]. Currently, there is no national standard of care with regard to PCa screening and national medical organizations differ in their screening recommendations [15–21]. However, most recommend that men learn about the pros and cons of PCa screening in order to reach an informed decision [16–19, 21]. Thus, widely applicable and easily disseminable approaches to health education are needed [22].

Informed decision making occurs when individuals understand the benefits, risks, alternatives and uncertainties surrounding a medical condition or procedure and are able to use this information in conjunction with their preferences to make a decision that is consistent with those preferences [23]. One approach to promoting informed decisions for PCa screening is the use of patient education materials and decision aids (DAs). The goals of DAs are to foster informed health decisions by: 1) providing facts about the condition and procedures; 2) helping patients to clarify personal preferences and values; and 3) encouraging discussions with medical professionals to guide health decisions that match these preferences [24]. DAs are considered particularly useful when efficacy is unclear, outcomes are uncertain, and/or subjective judgments about benefits and risks are required [24]. Cancer screening-related DAs are particularly important because they have been found to increase cancer-related knowledge without increasing anxiety [25].

Increasingly, cancer screening decision tools have begun to utilize the Internet [26–31]. Despite the digital divide and differences in Internet use among different age and racial groups [32], the percentage of Americans who use the Internet is continuing to grow [33, 34]. Internet users who access medical or health information have also increased between 2001 and 2007, from 66% to 76% for those aged 50 to 64 and from 60% to 71% for those over 65 [32]. These trends suggest that the Internet has vast potential as a widely accessible approach to delivering decision support materials for PCa screening.

The most recent systematic review of DAs for PCa screening was published in 2007, which presented the findings of 12 RCTs [35]. While we did not conduct our own systematic review, we used the same Medline search criteria used in Volk's review ('prostate cancer' and 'decision making') to locate RCTs published since the review, between January 2007 and June 2009. We located an additional six trials [27–29, 36–38], and thus there have been a total of 18 published RCTs evaluating materials designed to improve informed decision making regarding PCa screening [26–29, 36–49]. These trials have assessed print, verbal, Internet, video and interactive computer-based PCa screening DAs. We have provided a summary of these 18 published RCTs (see Additional File 1). Quasi-experimental studies [50–54], abstracts, and studies evaluating DAs designed to increase PCa screening were excluded from our summary. Of the 16 trials that assessed knowledge, all reported a significant improvement. However, inconsistencies were seen among the trials with respect to changes in decisional conflict, screening behavior, intent to screen, and active participation in the screening decision (see Additional File 1).

Although these were well-conducted trials, there were several limitations in the development and evaluation of these DAs. First, only 5 of the 18 studies [27, 38, 40–42] included a values clarification component to assist men in integrating the information and elucidating their preferences about PCa screening. This may explain why most studies reported only a modest improvement in participants' knowledge, or modest reductions in decisional conflict [27–29, 37, 40, 41, 43–46, 48]. Second, of the 4 web-based DAs, only one [27] utilized an interactive format, while the other studies with web-based interventions did not exploit the strengths of this medium [26, 28, 29]. Third, while one web-based tool utilized a tracking mechanism to monitor whether participants viewed the website [27], that study did not determine whether the amount of time spent and topics accessed on the site impacted outcome measures. Fourth, several of the studies reporting pre- and post-intervention evaluations had a brief follow up period of less than 1 month, thereby limiting the understanding of the long-term impact of the interventions on screening behavior and other outcomes [28, 38, 40, 41, 43, 44]. Finally, only 4 of the RCTs included a substantial number of African American (AA) men, who are at greatest risk for PCa [36, 38, 42, 45].

Our goal was to extend these prior studies by developing two new patient DAs, a booklet and an interactive web-based tool, that could be utilized in a variety of settings. We sought to create widely disseminable and relevant materials that would improve PCa knowledge and assist a heterogeneous population of men in making informed screening decisions. We incorporated a values clarification component into each DA, which is intended to help individuals determine their personal preferences and beliefs about PCa screening and to make informed choices in accordance with those preferences. We are currently conducting a three arm RCT (including a usual care arm) to assess the efficacy of these tools among a diverse sample of men accrued from primary care clinics. This paper describes the development and content of these two DAs, including a description of our prior feasibility studies and randomized trials, each of which contributed to the evolution of these tools.

There is considerable interest in assisting men with PCa screening decisions, as evidenced by the 18 RCTs conducted to assess the efficacy of DAs. We sought to address several limitations of the previous studies with the development of two disseminable tools with extensive formative evaluations: a print booklet and an interactive website. The booklet and the website offer the identical content, while the website also includes an interactive values clarification component, video testimonials, and tracking software to assess men's utilization of the website. The website recently received the 2009 American Public Health Association's award for Public Health Education Materials [66]. Our ongoing RCT will examine the impact of the website and booklet on PCa screening knowledge, decisional conflict, satisfaction with decision, health-related quality of life and screening behaviors. The trial will be completed in 2011.

Our new materials offer several improvements over prior DAs. Given the persistent problem created by the digital divide, regarding both limited access and preferentially attracting Internet-savvy users, we designed features of the website to appeal to more diverse groups. Our formative work and prior randomized trials included a large number of AA participants as well as participants from diverse socioeconomic backgrounds, which provided insights to design materials for these groups. For example, our DAs maintained a maximum of an 8^th grade reading level, information was provided in plain language, and a glossary defined terms used throughout the website and booklet. Further, we incorporated visuals, graphs and charts, all of which have been suggested as methods for increasing comprehension among low-literacy groups [31].

In addition to making the materials appealing and understandable to diverse groups of men, we also assessed the extent of web access within our target sample. We found that over an 18-month period, web usage among lower socioeconomic men had increased. These results are consonant with some findings from the Pew Foundation [67], although other studies have reported slower growth among low SES and minority groups [68]. Our ongoing trial will provide more definitive evidence regarding the impact of web- vs. print-based media for PCa screening education, as well as the extent to which we managed to bridge the digital divide. The testing of these DAs among minorities and low literacy participants will provide an important opportunity to validate effectiveness in this population, which tends to be less informed about screening options and less engaged in decision-making [69, 70].

To our knowledge, ours is the second study to describe an interactive web-based tool designed to educate men about PCa screening [27], and the first to utilize tracking software to compare website utilization patterns with patient outcomes. Potential advantages of using web-based materials include the relatively low cost of updating information and the increased capability of tailoring and interactivity, which may assist in the acquisition and integration of knowledge. For example, by tailoring the presentation of the first two video testimonials in response to the user's baseline screening preference, we have insured that men consider counterarguments to help balance their perspective. Also, the interactive nature of the web-based values clarification exercise was designed to actively engage participants and enhance the integration of knowledge. This was intended to help men make a decision that corresponds more closely with their own values and screening preferences, decrease decisional conflict, and increase decisional satisfaction.

Over the course of the development of these DAs, we have encountered several important issues that may be useful to others who are creating similar tools. First, there was a tradeoff between providing detailed information vs. risking that the materials would require more time than men would be willing to devote to them. Despite our best efforts to be concise, between 35% (booklet) and 50% (website) of the usability testing participants thought the materials were too long. As we did not want to exclude any pertinent information, it is possible that the length of our materials may deter some men from reading all of the text. However, with both the booklet and the website, we expect that men will selectively access sections of interest by using the Table of Contents.

Secondly, when we conducted our web usability testing, we provided a step-by-step instruction sheet for using the website. Men reported that the instructions were very helpful, particularly for those with less computer experience. Due to these findings, as well as what we know about the disparities between SES groups and Internet use, we have included the instruction sheet in the current randomized trial to ensure that men with less experience using the Internet will be able to successfully access and use our materials.

Finally, it was challenging to develop a DA that addressed the uncertainty of a screening test for men who had been undergoing regular screening and who were completely unaware of the uncertainty. The balancing act was to validate what men already knew while also providing information that was both counterintuitive and contrary to their previous impression. We worked to present the materials in an evenhanded fashion; however, results from the usability testing suggested that only a minority of men thought the booklet (14%) and website (36%) neither endorsed nor opposed screening. These findings highlight the fact that it may take more than a single exposure to materials such as ours for patients to grasp a message that is both complex and counter to one's current understanding and practices. While our usability testing provided critical information during the development process and our sample size was comparable to other studies involving usability testing [71, 72], a larger sample may have provided the feedback necessary to more effectively present the uncertainty and the message of neither endorsing nor opposing screening.

Despite the uncertainty surrounding PCa screening, most primary care physicians routinely order the PSA test for men over 50, and some engage in unsupported practices, such as screening patients over age 75 and referring such men for biopsies when PSA values are elevated [73–75]. Due to the logistic constraints they face [76], many physicians administer PCa screening with little opportunity to discuss the test beforehand [77]. However, evidence indicates that many men would prefer to make a shared PCa screening decision in conjunction with their physicians [78–81]. Consequently, access to an effective DA in the primary care setting may promote shared decisions among large numbers of men in the decisive period before testing occurs. In 2005, 80% of males had at least one visit with an ambulatory care physician [82], suggesting that an intervention implemented in this setting could have a widespread impact.

Providing assistance for informed decision making for PCa screening may be important for some time, particularly if a definitive recommendation either for or against screening does not emerge from the ongoing screening trials. We have detailed our efforts at developing print- and interactive web-based DAs to assist men in determining whether they prefer to be screened or not. Given that technological advances in medical screening tests will continue to occur faster than clinical translational research can keep pace, we hope that insights from the development of our decision tools will be applicable as other screening dilemmas arise.