Part 2: Patient information, informed decision-making and the psycho-social impact of prostate-specific antigen testing

Authors


Paul Hewitson, CRUK-Primary Care Education Research Group, Department of Primary Care, University of Oxford, Oxford OX3 7LF, UK.
e-mail: paul.hewitson@dphpc.ox.ac.uk

Abbreviations
PCRMP

Prostate Cancer Risk Management Programme

GMC

General Medical Council

HRQoL

health-related quality of life.

RATIONALE

There has been increasing interest in providing people with information about the benefits and limitations of undergoing medical procedures and tests. Health professionals and consumer groups alike feel that it is essential for people to be provided with enough relevant information to enable them to make an informed decision to either request or decline a medical procedure or test. This is especially important in relation to the PSA test for prostate cancer. The Prostate Cancer Risk Management Programme (PCRMP) was officially launched on 4 July 2001; the aim of the PCRMP is to ensure that men who are concerned about the risk of prostate cancer receive clear and balanced information about the advantages and disadvantages of the PSA test and treatment for prostate cancer [1].

Increasingly, many men are asking their GPs for a PSA test as a result of the increased publicity given to both the test and prostate cancer in the media [2]. The Department of Health and the National Health Service National Screening Committee recognize that men may request the PSA test either because they believe that PSA testing would increase the chance that their cancer would be cured if found at an early stage, or simply to relieve their anxiety about having prostate cancer, if the test result was negative [3]. Given the current controversy about the PSA test and its consequences, it is vital that men be provided with enough high-quality, relevant information for them to make an ‘informed choice’ about whether or not to request the PSA test.

The PCRMP ‘Information Pack for Primary Care’ was developed and distributed to GPs in England and Wales in September 2001 [4]. The pack includes health-professional reference material and an information sheet that is provided to men when they request the PSA test. This sheet is designed to allow men to gain a greater understanding of the possible benefits and harms of the PSA test, and the consequences of having the PSA test. The PSA test alone carries no significant risks, given that it is a simple blood test. However, there are several potential risks relating to the consequences of having the PSA test, including the possible harms of further testing (e.g. biopsy) or the potential side-effects associated with the available treatments. Given that the most uncertainty and lack of conclusive scientific evidence is related to the consequences of having the PSA test (e.g. the benefits of early detection, the effectiveness of prostate biopsy, doubt surrounding the impact that treatment may have on a man's quality of life, etc.) it is vital that men are fully informed of the possible ramifications that having a PSA test may hold.

This section of the literature review will focus on the main topics important for providing information to men about the PSA test and its consequences. Publications were searched systematically to identify studies on patient information, informed decision-making and the psycho-social consequences of PSA testing for prostate cancer (Fig. 1). All major medical and health-related databases were searched for the review (Appendix 1; the extensive search terms are available from the author on request). In addition, relevant government, professional and consumer databases and websites were also included in the search in an attempt to identify current recommendations for PSA testing for prostate cancer and recommendations for the content of information provided to consumers (detailed in the Introduction to this supplement).

Figure 1.

A flow diagram of the results of the systematic literature search (April 2004).

Because there is a strong relationship between patient information and informed decision-making, the review is divided into two sections: (a) patient information and informed decision-making; and (b) the psycho-social implications of PSA testing; the protocol is detailed in Appendix 2.

Each section will provide a brief synopsis of the currently available evidence and explore the implications that this evidence has on the information provided to men who are considering whether or not to have the PSA test for prostate cancer.

PATIENT INFORMATION AND INFORMED DECISION-MAKING

Traditionally, information had been provided to patients or consumers to allow them to understand a medical procedure, a particular condition, or indeed, to promote a certain health behaviour. Recently, there is growing emphasis on providing patients with balanced and relevant information to allow them to make informed choices or informed decisions about their healthcare. This section of the review will concentrate on the type of information on PSA testing that is currently available for men and the effectiveness of providing this information for informed decision-making.

EFFECTIVENESS OF PROVIDING PEOPLE WITH INFORMATION

Providing people with information about a medical procedure or treatment is effective in several ways. There is good evidence to suggest that interventions designed to assist patient decision-making can improve knowledge, increase patient participation in the decision-making process, and allow patients more realistic expectations of the benefits and harms of the procedure or treatment [5]. Furthermore, these interventions can also reduce decisional conflict surrounding a choice, whilst not significantly increasing the anxiety of the individual [6,7].

GUIDANCE ON PROVIDING INFORMATION TO PATIENTS AND THE PUBLIC

Although it is accepted that the provision of information materials for patients can have beneficial effects, there is scant guidance available about what information should be included and what are the core concepts that patients are required to understand. One of the few organizations to provide a definitive framework for the content of information that patients should be given for medical investigations was developed by the General Medical Council (GMC) in the UK. The GMC released ethical guidance that doctors are expected to follow when seeking patients’ informed consent to medical investigations such as screening [8]. This guidance states that anyone considering whether to consent to a screening test must be able to make a properly informed decision based on the information available and also must be informed of:

  • • the purpose of the medical test;
  • • the likelihood of positive/negative findings and possibility of false-positive or -negative results;
  • • the uncertainties and risks attached to the testing process;
  • • any significant medical, social or financial implications of testing for the particular condition or predisposition;
  • • follow-up plans, including availability of counselling and support services [8].

The goal of the PCRMP closely approximates this guidance, in that both stress the importance of providing relevant, high-quality information about the medical investigation and its consequences, and that this information should be readily understood to allow an individual to make an informed decision.

PUBLIC KNOWLEDGE OF PROSTATE CANCER AND PSA TESTING

It is necessary to establish the current level of understanding of men in the general population in an effort to gauge the type and amount of information that should be provided about the PSA test and its consequences. There are few studies available that have attempted to access the knowledge the general public holds in relation to prostate cancer.

Published studies show that men lack basic knowledge about prostate screening and prostate cancer [9–11]. A recent international study aimed to access the level of awareness of prostate cancer in six European countries (France, Germany, Italy, Spain, Sweden and the UK) and the USA [12]. The study found that only 22% of men in the UK were aware of the PSA test and only 1% of all respondents were aware that prostate cancer could be asymptomatic. The study also found that 82% of men in the UK would use GPs as their main source of information about prostate cancer. The relatively poor knowledge that men in the UK have in relation to PSA testing and prostate cancer, coupled with men's reliance on information provided to them by their GP, highlights the need for the PCRMP to disseminate information about PSA testing and the importance for this information to be of the highest possible standard.

RECOMMENDATIONS OF ORGANIZATIONS FOR PROSTATE CANCER SCREENING

Several government and professional healthcare organizations have provided recommendations about the introduction of prostate cancer screening for asymptomatic men (see Introduction). Major organizations were identified through a search of electronic databases and hand-searching of journal articles. Although not an exhaustive list, 24 government, professional and consumer/patient organizations from Europe, Australasia and North America were identified. Only three organizations, the American Cancer Society [13], the American Urological Association (AUA) [14,15], and the Canadian Urological Association [16,17], support routine population screening for asymptomatic men; all other organizations either do not support mass screening for prostate cancer, because of lack of evidence, or indicate that the use of the PSA test should be made on an individual basis.

Along with recommendations about the routine use of PSA testing for prostate cancer, most organizations also stress the importance of providing information to men and enabling them to discuss this information with a designated health professional. However, the recommendations are generally very broad and do not specify the content or the most satisfactory ways to present information to men about the benefits, risks and consequences of having a PSA test. Indeed, only the American College of Physicians [18,19], and the Royal College of Radiologists/BAUS [20] guidelines offer explicit statements that should be included in patient information materials or discussions.

INFORMED CONSENT AND THE PSA TEST

There are many articles debating the relative merits of requiring men to participate in a formal informed-consent procedure before undergoing PSA testing. Proponents of the formal informed-consent approach cite the uncertainty surrounding the effectiveness of PSA testing, possible medico-legal issues that may arise from not providing full consent, and further, that patients have a fundamental right to have explained all the potential implications of the procedure and possible future outcomes [21–23].

Whilst most opponents of the formal informed-consent procedure agree that men should be made aware of the benefits and limitations of the PSA test for prostate cancer, they suggest that there are significant barriers and possible disadvantages to this approach. For example, reasons proposed for not providing formal consent include the lack of time during consultations to provide truly informed consent, that it would impose an additional (and unnecessary) regulation to the delivery of medical care, and that the consent procedure would dissuade men from having a PSA test [24–26].

Clearly, without definitive answers to the effectiveness of PSA testing in reducing the mortality and morbidity associated with the early detection of prostate cancer, the debate about informed consent will continue. Difficulties concerning what information should be included, how this information should be presented and the best method for ensuring that a man has adequately understood the information is not confined to the debate amongst health professionals. An important study that highlights the differences in perspective between health professionals and patients was reported by Chan and Sulmasy [27]. This investigation compared the information that a panel of national experts rated as important to understanding the PSA test and its consequences with 24 screened and unscreened men (and their partners) from the general population. The results indicated that the physicians and patients agreed on certain key facts that men ought to know about PSA screening, but that physicians failed to emphasise some facts that patients deem important [27]. It is imperative for the development of any patient information material for PSA testing to incorporate the views of men about what they feel to be most important for making a decision.

RECOMMENDATIONS ON THE CONTENT OF INFORMATION ABOUT PSA TESTING

Presently in the UK there are no definitive recommendations for the content of information on the benefits and limitations men should be given when requesting a PSA test. Nor is it the purpose of this review to make these types of recommendations. However, it is clear from the recommendations by organizations about prostate cancer screening, the previously identified debate on informed consent, and the seminal work by Chan and Sulmasy [27] that the content of information in patient materials should:

  • • be statements that men feel are important for them to understand when considering to have the PSA test, with its consequences;
  • • be shown, through high-quality research studies, to significantly contribute to men's decision-making process;
  • • include statements that health professionals believe are important for men to understand;
  • • be able to facilitate discussions, conforming to the shared decision-making paradigm, between health professionals and men.

EFFECTIVENESS OF PATIENT INFORMATION FOR PSA TESTING

There are several ways that men can receive information about the PSA test and its possible consequences. These include written materials (i.e. the single sheet of information provided in the PCRMP Information Pack, or an information booklet such as ‘Understanding the PSA test’ developed by Cancer BACUP), visual materials (i.e. information provided in a video format or on CD-ROMs) and verbal explanations by health professionals.

After the development of a protocol for the review (Appendix 2), published articles were identified from 1993 to the present, on the effectiveness of providing information to men about the PSA test and the psycho-social reactions men have to the screening process; 17 such articles were identified for patient information. An updated search in the first week of September 2004 identified two further studies that were also included in this section of the review. Therefore, 19 articles were included in the knowledge and patient information section of the review.

There was considerable variation in the quality of the methods and execution of identified studies, and in the types of participants, aims of the studies, recruitment procedures and types of outcome measured. Although these studies were identified using a systematic search, not all the studies would conform to the inclusion criteria of a traditional systematic review, because of the divergent methods and quality of the studies. The inclusion criteria for the studies in this part of the review were based on the study evaluating some type of information material (written, videotape, verbal or a combination of methods) and that the study measured outcomes relating to improving the understanding or decision-making process for men considering the PSA test for prostate cancer.

OVERVIEW OF VERBAL INFORMATION STUDIES

Eight of the publications [28–35] were primarily concerned with verbal explanations of the PSA test and prostate cancer. One study [28] involved a very brief (5–15 min) verbal explanation of basic information about prostate cancer. Two of these studies [30,32] used a survey design to establish the effectiveness of an educational-seminar programme for improving the awareness and knowledge of prostate cancer for African-American men. One study [29] used a qualitative method to explore the reaction and utility of ‘neutral’ PSA counselling. The three studies by Wolf et al.[33–35] were concerned with a randomized controlled trial of a scripted educational intervention for informing men about PSA testing. The study by Sheridan et al.[31] recruited men presenting for a routine appointment at a university internal medicine clinic.

The large scale survey by Wilkinson et al.[32] was an extension of the feasibility study reported by List et al.[30]. The seminar used in these studies was reported to include information (directly pertaining to African-American men) about risk factors for prostate cancer, early-warning signs, controversies about screening, current treatments and common myths presented using diverse audiovisual materials [30,32]. The PSA counselling study [29] reportedly focused on two main messages; that there is uncertainty in medical science regarding the effectiveness of routine PSA testing (individual clinicians holding different views) and that benefit vs harm of undergoing PSA testing for an individual requires weighing and evaluation of the various risks associated with the treatments for prostate cancer. It also included information on the epidemiology and natural history of prostate cancer, and the estimated probabilities of true-positive, false-positive and false-negative results from PSA testing. The three publications by Wolf et al.[33–35] were based on a verbally delivered scripts which included information on the lifetime probability of developing and dying from prostate cancer, PSA test characteristics, evaluation of abnormal test results, and the uncertain benefits and risks of early prostate cancer treatment. The study by Sheridan et al.[31] involved verbally conveyed information (10-min scripted pamphlet or decision-aid delivered by a trained health educator) presented in conjunction with a flip-chart. Men were able to read along the flip-chart during the presentation. The decision-aid was presented in four parts (information on the natural history and epidemiology of prostate cancer, the PSA test, the prostate biopsy/treatment options for prostate cancer, and two balance sheets presenting the benefits and harms of screening).

RESULTS OF VERBAL INFORMATION STUDIES

The educational seminar studies showed that the mean score on the knowledge scale used significantly increased from 20–26% before the seminar to 57–73% afterward [30,32]. In the study by Wilkinson et al.[32] there were significant correlations between high knowledge scores and increasing levels of income, education and family history of prostate cancer. Also, a higher level of education, income or family history of prostate cancer strongly predicted men who had previously been screened for prostate cancer; 63% of the sample indicated that they would undergo screening, 19% stated they would not and 18% did not respond or were female. The study by Collins [28] reported that 21% of men answered all seven knowledge questions correctly before the verbal information was presented, increasing to 64% of men after they received this information. There are several methodological problems with this study and the verbal information seems to have focused on the DRE, as opposed to any information about PSA testing.

The intention study [33] reported that men in the information group were significantly less interested in undergoing screening than men in the group with no information. A family history of prostate cancer was significantly associated with greater interest in screening, whereas advancing age was associated with less interest in screening. The authors of the study concluded that an informed-consent discussion about PSA testing decreases men's interest in participating in screening. In the predictors-of-interest study [34], a family history of prostate cancer, the perceived efficacy of the PSA test, perceived susceptibility for prostate cancer and younger age predicted interest in screening for men who received the information. For men who did not receive information, perceived efficacy, perceived seriousness of prostate cancer and willingness to accept treatment risks were significant predictors of interest in screening. The authors suggested that an informed-consent process can alter the factors associated with an interest in prostate cancer screening and, regardless of the knowledge imparted to an individual, men who believe that the PSA test will prevent health problems are more likely to desire screening. In a study of older men [35], informed men were less interested in screening than uninformed men, with ‘being married’ significantly predicting an interest in screening. Perceived seriousness of prostate cancer was the strongest predictor among uninformed men. In both groups, perceived efficacy of the PSA test correlated with interest in screening.

In the qualitative study [29], although the authors reported that the information presented to men was balanced and neutral in content, 37 (93%) of men considered the counselled information as unfavourable to PSA testing. However, 30 (75%) of men indicated that they intended to undergo testing in the future (including 29 men who had previously been tested). Only two of 10 men who had not previously had a PSA test indicated that they intended to be screened in the future. The authors reported that men's underlying beliefs were the main reason that they dismissed the counselled information. The qualitative analysis revealed that these beliefs were related to the fear of cancer, relevance of salient anecdotes, distrust of statistics, protection from bad luck, faith in science and valuing the PSA test as knowledge for its own sake (e.g. to receive the test results). Significantly, one of the underlying beliefs reported by men as a reason to dismiss the counselled information was their enthusiasm for the idea of prevention. This belief was interpreted as meaning that, even though men felt that the information they had received suggested that the PSA test was not as good a test as they first believed, the idea that ‘prevention is the best medicine’ superseded the negative reaction to the information. The authors concluded that underlying patient beliefs may make counselling and decision-support methods less effective. It was suggested that eliciting the patient's beliefs before counselling may improve the shared decision-making process.

The study by Sheridan et al.[31] reported that before viewing the decision-aid, 70% of men knew the advantages of screening for prostate cancer and 40% knew the disadvantages. Unfortunately, the authors do not indicate how knowledge of the advantages and disadvantages was assessed (e.g. whether this was a psychometrically validated scale or one question). Although 63% of the participants reported that they felt they knew enough to decide about screening, 86% of the men reported that they wanted either some or a lot of additional information. After receiving the decision-aid, 98% of men reported that they knew the advantages of screening and 95% reported knowing the disadvantages. In terms of interest in prostate screening before the decision-aid, 76% reported being interested in screening, 8% were not and 16% were undecided. After viewing the decision aid, 78% reported being interested in screening, 14% were not and 8% were undecided. The authors reported that overall, 20% of men in the study changed their interest in screening, whilst 80% reported no change. The strongest predictor of men's interest in screening after receiving the decision-aid was previous interest in screening. The authors reported that their results suggest that many men have already decided about screening before receiving information. In their conclusions, Sheridan et al. plotted the proportion of men previously screened with PSA against the change in the proportion of men interested or screened, for three previously published studies [36–38]. This innovative attempt to summarize the influence of previously screened men indicated that decision-aids reduce interest in populations in which fewer men have been previously screened.

SUMMARY OF VERBAL INFORMATION STUDIES

Several of the verbal information studies [28,30,32] are primarily concerned with promoting knowledge about prostate screening and prostate cancer to African-American men. Men's responses to the knowledge scales were shown to increase after receiving information about prostate cancer and prostate screening. In the absence of information on the content of the material in the educational interventions, it is not possible to establish the utility of these studies for men in the UK (e.g. it is uncertain if the educational intervention focused on promoting screening for prostate cancer or not).

The reports by Wolf et al.[33–35] reported that a verbal discussion that conformed to an informed consent process decreased men's interest in prostate screening. There were several differences in the predictors of interest in PSA testing between men who received information and those who did not. This suggests that although information about prostate screening can decrease the interest in having the PSA test, there may be other factors, extraneous to providing information alone, which mitigate a man's decision to undergo prostate cancer screening and require further investigation (e.g. the perceived seriousness of prostate cancer and a willingness to accept the risks of treatment are important predictors for men who did not receive information). Only the perceived efficacy of the PSA test was reported to predict interest in PSA testing for both groups of men.

The study by Sheridan et al.[31] found that providing a decision aid increased men's knowledge of the advantages and disadvantages of prostate screening. However, it is uncertain how knowledge of prostate cancer screening was evaluated in this study. These authors also found that interest in prostate cancer screening was high at baseline and remained high after administering the decision-aid. The authors suggested that either previous interest in prostate screening or previously having a prostate screening test may reduce the impact of information materials on men's preferences for screening. This concept is reinforced by the qualitative study [29] which suggested that men's underlying beliefs, even after the presentation of information that is perceived as negative, have important implications for men making a decision about having a PSA test. This study also suggested that men who have previously had a PSA test intend to be tested in the future, regardless of the information that is presented to them.

OVERVIEW OF WRITTEN PATIENT INFORMATION

Four of the 19 reports identified [39–42] were primarily concerned with written patient information material about prostate screening and prostate cancer. All of the included studies used randomization methods to allocate participants to their study groups. Two of the studies [40,41] compared well-designed written material (that included qualitative and quantitative information on the risks and benefits of PSA screening and prostate cancer treatment) to general written material about PSA testing and prostate cancer. The other two studies [39,42], compared written material with usual care (e.g. no information).

The study by Davison et al.[39] involved providing verbal and written information to men to ascertain if this enabled men to take a more active role in decision-making about prostate cancer screening. The information provided concerned the controversies surrounding prostate cancer screening and the pros and cons of having a DRE and/or PSA test. The study by Wilt et al.[42] used a two-sided information sheet, based on validated material determined to be important for shared decision-making, which described the potential risks and benefits of early detection and treatment for prostate cancer.

Two of the identified studies [40,41] used written patient materials which focused on the perceived utility of including qualitative and quantitative outcomes to explicitly communicate the benefits and risks of screening and treatment for prostate cancer. The Australian-based study [40] compared a 32-page evidence-based booklet with a short government publication. Although lengthy, the well-designed booklet covered a range of topics previously identified as essential to informed decision-making about PSA screening. The USA-based study [41] developed a pamphlet decision-aid that was designed to present prostate screening outcomes in a balanced manner. The decision-aid was developed using focus groups to help highlight issues that men found difficult to understand. Both these studies presented information in a qualitative and quantitative form, using graphic representations or illustrations to convey the sensitivity and specificity of prostate cancer screening outcomes to men.

RESULTS OF WRITTEN INFORMATION STUDIES

The decision-making study [39] found that men who received information preferred to assume a more active role in making a decision about screening. The roles men preferred to take in the screening decision were also highly correlated with the roles the physicians perceived that their patients would prefer. The study also showed that men who received information had significantly lower levels of decisional conflict than men who did not receive information, although there were no differences between the groups in the level of anxiety experienced. An interesting outcome, although not well reported in the study, was that more men in the information group were screened (28%) than men in the group with no information (21%).

The trial of a mailed pamphlet [42] showed that men who received information were better informed than those who did not. This study used the same three knowledge questions as an earlier study of an educational videotape [37]. The overall proportion of questions answered correctly was higher in the informed (45%) than in the uninformed group (32%). However, only 11% of men in the informed and 4% in the uninformed group were able to answer all three questions correctly. Although not significantly different, men in the informed group were slightly more likely to talk with their physicians about screening and slightly less likely to recommend screening to other men. Men in the informed group were significantly more likely (46%) to choose watchful waiting if they were diagnosed with prostate cancer than were the comparison group (35%). Furthermore, having a PSA test in the year after the educational intervention did not significantly change between the groups (information 31%, vs no information 37%).

The randomized trial of the illustrated decision-aid [41] found that although there was no difference between the groups in terms of their score on the knowledge scale before receiving information, after receiving information men in the decision-aid group had a significantly higher mean knowledge score (15.0) than men who received the basic information pamphlet (14.1). Men in the decision-aid group were significantly more likely to be aware of the possibility of false-negative and -positive screening results, and further, had a better knowledge of the natural history of prostate cancer. After receiving the information, significantly fewer men in the decision-aid group believed that the PSA test was infallible and were significantly more likely to believe that most men with prostate cancer will die from something else. Both groups felt that they were better able to make an informed choice about prostate screening. However, 82% of the decision-aid group and 84% of the pamphlet group had prostate cancer screening, although this may be because free screening was being offered.

Men who received the evidence-based booklet had significantly better knowledge (half of 10 items answered correctly) than men receiving the government pamphlet (45% correct) for the Australian randomized trial [40]. Men receiving the booklet also had significantly lower levels of decisional conflict, felt they were able to make an informed choice, and were better able to estimate the lifetime risks of a man developing or dying from prostate cancer. Both groups were significantly less interested in having a PSA test after they had received the information about PSA screening. More than three-quarters (80%) of men in the booklet group stated that the information about the benefits and risks of PSA screening was ‘about right’, as opposed to 53% of men in the pamphlet group.

SUMMARY OF WRITTEN INFORMATION STUDIES

Three of the identified written information studies measured knowledge as a primary outcome [40–42]. In only one [41] were men able to answer more than half the knowledge questions correctly after receiving the information. Indeed, in one study, only 11% of men were able to answer all three questions correctly after receiving information [42]. Furthermore, although the differences in the knowledge scores between men who received information and those who did not were statistically significant, the actual difference between the groups was only one question or less (i.e. men who did not receive information or low-quality information could answer one less question on the knowledge scales than men who were provided with information).

Men who received information were reported to take a more active role in decision-making with their physician, had lower levels of decisional conflict and felt that they were better able to make an informed choice about PSA testing. Furthermore, men who received high-quality information were more accurate in their estimates of the lifetime risk of developing prostate cancer, the natural history of prostate cancer and the meaning of the test results [40,41]. In one study [42], men who received information were more likely to choose watchful waiting than more invasive forms of treatment, suggesting that the risks associated with treatment conveyed in the information material affected men's decisions. The Australian study [40] showed that regardless of the quality of the written material, men were less interested in PSA testing after they had received information.

The most striking outcome of these studies was the lack of any significant differences in the uptake of PSA testing. In two of the studies that reported the uptake of PSA testing [41,42], men who received written information were only slightly less likely to have a PSA test, with one study [39] reporting that more men in the information group had a PSA test than those who did not receive information. Importantly, the percentage of men who had a PSA test was dramatically higher for the study which offered free PSA testing [41] than the studies which did not [39,42].

OVERVIEW OF VIDEOTAPE PATIENT INFORMATION

Six of the 19 publications [36–38,43,44] concerned the use of videotape information. One study [37] reported the results of two separate studies conducted with videotape interventions. Another study [44] reported a 1-year follow-up of men involved in a randomized controlled trial. One of the studies [36] combined both videotape and verbal discussion for presenting information to men. The study by Partin et al.[45] reported the results of a large-scale randomized study comparing three groups (mailed pamphlet, mailed videotape and ‘usual care’).

Flood et al.[37] reported the results of two separate studies; one involved men who were offered free PSA testing after watching one of two videotapes, with the second study involving men attending a routine physical examination. Both of these studies involved the use of an educational videotape that encouraged men to participate in the decision to be screened for prostate cancer. Two physicians took the role of patients, with one emphasising the uncertainty surrounding the effectiveness of treatment and the other the regret he would feel if he did not take preventive action if later diagnosed with prostate cancer. One of the two studies reported [37] used a control videotape that promoted screening and did not include information of the potential risks of treatment, and the other study did not. The well-designed and conducted randomized controlled trial [38] used a videotape intervention that was 20 min long and included information on the epidemiology of prostate cancer, accuracy of the PSA test and complications of treatments for prostate cancer (the videotape tape group also received a written brochure which included information presented in the videotape).

The participants in the study by Frosch et al.[36] were divided into four groups. One group of men listened to a lecture about the nature of prostate cancer, and the risks and benefits of treatments for prostate cancer. The second group of men watched a videotape about prostate cancer screening previously developed by Flood et al.[37]. The third group viewed the same videotape and participated in a group discussion with a moderator. The control group were offered the PSA test as part of their physical evaluation but received no information. Only one study compared an Internet-based decision-aid with a videotape decision-aid [43]. Participants were randomized to either view a videotape describing information relevant for making an informed decision about the PSA test, or to access a website decision-aid that contained the same information presented on the videotape.

The study by Partin et al.[45] randomized participants to either receive a written pamphlet, view a videotape (previously described by Flood et al.) or usual care (control group). The written information group received a pamphlet designed to provide a balanced representation of the risks and benefits of screening. The pamphlet describes the prostate, prostate cancer, the PSA test, the reasons why not all doctors agree with the PSA test and the accuracy of the PSA test, the difference between prostate cancer and BPH, and the unknown efficacy of treatment options. The pamphlet emphasizes that the patient should play an active role in the decision to either have or not have a PSA test.

RESULTS OF VIDEOTAPE INFORMATION STUDIES

Men in both studies reported by Flood et al.[37] who viewed the educational videotape had better knowledge of the natural history of prostate cancer, the efficacy of treatment and the predictive value of PSA testing than did men who either viewed the pro-screening videotape or no information. Furthermore, men in the educational videotape groups strongly indicated that if they were diagnosed with prostate cancer, they would prefer watchful waiting rather than active treatment (e.g. radical prostatectomy or radiation therapy). In the free PSA-test study, 74% of men who viewed the educational video indicated that they would have a PSA test in the next 2 years, compared with 90% of the pro-screening videotape group. In the scheduled-visit study, only 30% of the educational videotape group indicated that they would have PSA testing in the next 2 years, compared with 67% of the men who did not see the videotape.

The randomized controlled trial of the educational videotape [38] found that both groups of men, on average, were able to answer only about three of the 10 knowledge questions at the beginning of the study (2.7 correct questions for the information group vs 2.8 for the uninformed group). At the 2-week follow-up men in the videotape group correctly answered a mean of 4.8 questions, vs 3.1 for the uninformed group. At the beginning of the study, almost 80% of men (79% videotape, 78% no information group) indicated that they would have a PSA test. At the 2-week follow-up a significantly smaller proportion of men (62%) in the videotape group would have a PSA test, compared with 80% of men in the uninformed group. Most men in the videotape group reported that the videotape influenced their decision whether or not to have the PSA test.

Men who were involved in this study participated in a follow-up study 1 year later [44]. There were no differences between the groups in attending for a physical examination or reporting to have had a DRE. However, 34% of men in the information group reporting having a PSA test, vs 55% of the uninformed group. The authors indicated that this difference between the groups was partly explained by African-American men being almost twice as likely as white men to have the PSA test, possibly because the former are aware of their increased risk of developing prostate cancer (as highlighted by the videotape). The knowledge score for the information group declined from 4.8 to 3.8 questions answered correctly at 1 year after receiving the information. The knowledge score for the uninformed group did not change, and there were no differences between the groups in the satisfaction with their decision.

In the combination study [36], 81.5% of participants who viewed the videotape thought that it presented balanced information about prostate cancer screening. Men who received information about the PSA test and prostate cancer (both discussion and videotape groups) had significantly higher knowledge scores than the ‘usual-care’ group; 35% of men in the latter group reported being either ‘considerably’ or ‘extremely’ concerned about prostate cancer in comparison to the videotape-only (13.4%), discussion-only (13.3%) or combined-intervention (16.7%) groups. There were significant differences among the groups in who the men felt should make the decisions about PSA testing; 49% of men in the usual-care group wanted their physicians to be the primary or only decision-makers, compared with the videotape (2.3%), discussion (4.4%) and video/discussion (7.5%) groups. Furthermore, 36% of men in the usual-care group would choose watchful waiting if they were diagnosed with prostate cancer, vs 73% in the videotape, 82% in the discussion and 67.5% in the video/discussion groups.

The second study by Frosch et al.[43] found that there were no differences between the videotape and Internet groups in their rating of the convenience of the information materials, the effort required and the satisfaction with presentations. Men assigned to the videotape group were significantly more likely to review the educational materials than were the Internet group. Indeed, 46.5% of men assigned to the Internet group did not even review the materials before attending their screening appointment. The study also showed an increase in knowledge scores from before to after the test for both interventions, and men in the videotape group had a greater increase in knowledge scores than men in the Internet group (although this would be a result of nearly half the Internet participants reviewing none or only part of the information material). Almost all (99%) the men in the videotape and all men in the Internet group indicated that they would want a PSA test before they received the information material. After the educational intervention, 81.5% of the videotape group and 92% of the Internet group requested a PSA test. Men in both groups were more likely to endorse ‘watchful waiting’ as their preferred treatment choice if they were diagnosed with prostate cancer.

The main aim of the recent publication by Partin et al.[45] was to assess the effectiveness of a mailed videotape or mailed pamphlet for increasing knowledge about prostate cancer and participating in decision-making. The study used a previously published, well-developed and evaluated 10-item psychometric scale to assess the knowledge of participants [46]. Given the rather low percentage of men viewing the mailed materials (56% of men in the videotape group and only half the men in the pamphlet group reported looking at the materials mailed to them), the results of the knowledge scale were reported as adjusted and unadjusted for incomplete interventional exposure. The adjusted mean scores were 7.4 for the videotape (7.75 unadjusted), 7.3 for the pamphlet group (7.45) and 6.9 for the control group (6.97). The videotape group mean knowledge score was significantly higher than in the control group for both the adjusted and unadjusted scores, whereas the pamphlet group was only significantly higher compared with the control group in the adjusted analyses.

Four further items measuring men's knowledge of the accuracy of the PSA test, the natural history of prostate cancer, treatment efficacy and disagreement among experts were also assessed. Although men scored fairly high on the knowledge scale, their responses to three of the four questions was relatively low (although significantly higher for the intervention than for the control group). For example, ≈ 20% of men in the intervention group correctly indicated that treatments for prostate cancer have not been shown to extend a man's life. Men in the videotape (61%) and pamphlet groups (64%) were significantly less likely to intend to have a PSA test within the next year than were those in the control group (72%). However, there were no differences among the groups in actually having the PSA test within a year (videotape 67%; pamphlet 67%; control 70%). A significantly higher percentage of men in the intervention groups also indicated that they had discussed the PSA test with their physician at their last medical visit than had the control group. The authors concluded that although neither of the interventions had a significant impact on PSA testing, both modestly increased knowledge about prostate cancer screening and self-reported participation in decision-making.

SUMMARY OF VIDEOTAPE INFORMATION STUDIES

Most articles included in this section were primarily concerned with the use of videotape interventions, with three studies [36,43,45] using combined materials. In comparison to the written information studies, the videotape studies achieved a greater increase in mean knowledge scores. This may indicate that information about the PSA test and prostate cancer presented in a familiar visual medium is more easily understood or retained than are written materials. Conversely, this may also be a result of the method of evaluation (the videotape studies generally evaluated knowledge immediately after the men viewed the information material, unlike the written information studies) and that only three [37] to five questions [36] were used to evaluate knowledge. Given the relatively high mean knowledge score for the control group in the study by Partin et al.[45], this may also be a result of men in the USA being more familiar (either through mass media or health promotion activities) with the controversies surrounding the PSA test for prostate cancer. Interestingly, one of the highest quality studies [38] included in this section reported knowledge scores comparable with those in the written information studies. However, the results of the most recent high-quality videotape study [45] found minimal differences between the relatively high knowledge scores for the videotape and written information groups.

Men who received information were also less likely to report that they intended to have a PSA test in the future. Two studies attempted to assess PSA testing at 1 year [44,45]; that by Volk et al.[44] found that men who had viewed the videotape were significantly less likely to have had a PSA test than men who did not receive information. However, the other study [45] reported that there were no differences among the three groups in the uptake of PSA testing. In common with the written-information studies, men who viewed the videotape information preferred watchful waiting to more invasive forms of treatment if they were diagnosed with prostate cancer [36,37,43]. One study [36] suggested that men were less concerned about prostate cancer and would prefer to have a more active role in the decision-making process if they had received information material. Frosch et al.[43] also suggested that it may be necessary to organize a specific time with the men to view the educational material, as only about half the men in that study who were required to view the Internet information in their own time managed to complete the task. This was similar to the study by Partin et al.[45] where only half the men in the pamphlet and 56% in the videotape group viewed the information material sent to them by mail.

IMPLICATIONS OF INFORMATION MATERIAL STUDIES

The main implications of the studies included in this review are: (a) knowledge is increased with the provision of information; (b) men are less interested in requesting a PSA test after receiving information, although this was highly dependent on the type of screening offered and the method of information provision.

KNOWLEDGE

Men who received information were shown to increase their knowledge of both prostate cancer and prostate cancer screening, and have higher knowledge scores than men who did not receive information. Given the public's overwhelming lack of knowledge in relation to prostate cancer and screening [12], it is absolutely essential that men who request a PSA test in the UK are fully informed of the implications of the PSA test and its consequences. It is clear that providing information to men will increase their knowledge of concepts that are particularly important to prostate cancer screening. Indeed, men are better able to correctly estimate the lifetime risk of developing prostate cancer, the meaning of test results, the natural history of prostate cancer and the efficacy of treatment [36,40–43]. However, from the reviewed reports it is unclear what information men feel is most important to them when making a decision about the PSA test. The number of items and knowledge scores for the studies included in the review are shown in Table 1[36–38,43–45].

Table 1.  The number of items and percentage of correct responses for knowledge scales, and the percentage uptake of the PSA test for studies included in the review
RefN ItemsIntervention (%)Control (%)
  • *

    This article included two studies, one offering free PSA testing (F) and one PSA testing at a later scheduled appointment (S); d, discussion group; v, videotape group; c, combined videotape and discussion; w, written information group; m, multimedia group.

Video
[37]* (F) 36631
[37]* (S) 37927
[36] 576 (d) 68 (v) 77 (c)34
[43] 568 (v) 56 (m)
[38]104831
[44]10 (1 year)3830
[45]1078 (v) 75 (w)70
Written
[42] 34534
[40]105045
[41]188378
Uptake of PSA test, %   
Free PSA test
[41] 8284
[36] 82 (d) 63 (v) 50 (c)97.7
[43] 81.5 (v) 91.1 (m)
[37]* (F) 98.4100
No free PSA test
[42] 3137
[40] 2725
[44] 34.3 (1 year)55.2 (1 year)
[45] 70 (v) 67 (w)69
[37]* (S) 11.722.6

An obvious criticism of the reported increase in knowledge is that many of the studies did not provide the comparison groups with any information about prostate cancer or PSA testing. If one group receives information and the other does not, it is not surprising that the latter group would not perform well on a knowledge test. A second criticism of these results is that many of the scales used to determine the knowledge of participants were not psychometrically evaluated (e.g. the reliability and validity of the scales were not reported). Only two scales used to evaluate knowledge [38,44,45] have been subjected to any psychometric evaluation.

The most poignant problem for evaluating ‘knowledge’ conferred by patient information materials is that there is no available research to suggest that the items (e.g. knowledge questions) included in the various knowledge scales directly relate to the decision-making process of men. Although men will have increased their knowledge of prostate cancer and screening after receiving information material (as identified by their scores on the knowledge scale), how this knowledge affects their decision-making and subsequent behaviour requires urgent further investigation. For example, men seem less likely to have a PSA test after receiving information, but it cannot be inferred from the results of the knowledge scales if this is a result of specific information about prostate cancer (e.g. misconceptions concerning the average age of diagnosis, lack of evidence for natural history, etc.), the effectiveness of the PSA test (e.g. false-positives/negatives, etc.), follow-up testing (e.g. effectiveness of biopsy, etc.) or the benefits and risks of treatments for early prostate cancer. Furthermore, how men incorporate their personal attitudes and beliefs towards cancer prevention and the role that significant others (e.g. family, health professionals, etc.) have in the decision to request a PSA test are also areas which need concerted research attention.

INTEREST IN PSA TESTING

In general, interest in having the PSA test decreased for men who received information material, but the difference in interest between men receiving information and those who did not was highly variable, and depended on the type of screening being offered (i.e. free PSA testing or not). Studies that assessed the actual uptake of screening behaviour are also shown in Table 1.

From Table 1 it is obvious that if free PSA testing is offered, the effectiveness or impact of information provided is greatly decreased. This is dramatically clear in the results of the study by Flood et al.[37]. When free prostate cancer screening was offered, more than three times as many men elected to have a PSA test after viewing information material. The combined study [36], which included both verbal and videotape information, showed that if a discussion is conducted after viewing information material, fewer men are interested in PSA testing than for discussion or videotape information alone. This suggests that there may be a significant role for shared decision-making with a health professional after men have received and assimilated information about the PSA test and its consequences.

Importantly, most studies only included outcomes relating to a man's intention to seek a PSA test, not the actual behaviour. The two studies by Volk et al.[38,44] showed that although 62% of men in the group that received information indicated that they would choose to have a PSA test after receiving the information, only 34% of men in the follow-up study had had a PSA test within a year of receiving the intervention. For men who did not receive information, 80% planned to have a PSA test, with 55% of men having the test within a year [38,44]. This suggests that future research studies should concentrate on evaluating the behaviour in question (e.g. having a PSA test within a year), as estimates of men's intention to have a PSA test may exaggerate the actual number of men requesting a PSA test and may affect public health policy decisions.

There are also less conclusive implications of the studies included in this section, i.e.:

(a) Treatment choice: men who receive information may be more likely to choose active monitoring or watchful waiting rather than more invasive treatments. The reasons for this are not elucidated in the studies assessed [37,42], although this may relate to either a greater understanding of the natural history of prostate cancer or concern about the risks associated with the more invasive treatments options. However, the men in these studies were not diagnosed with prostate cancer, and therefore any choices about treatment options are based on a hypothetical situation;

(b) Improved decision-making: four studies [39–42,45] indicated that men who received information were more involved in the decision-making with health professionals, had less decisional conflict and felt that they were more able to make an informed decision. Further research work is required to clarify the impact that information can have for reducing decisional conflict in men considering the PSA test, and how this information can facilitate shared decision-making with health professionals;

(c) Individual factors: the articles by Wolf et al.[33–35] indicate that personal perceptions (e.g. the perceived seriousness of prostate cancer), age (e.g. younger men more interested in having a PSA test) and family history are important factors in determining a man's interest in having a PSA test. The qualitative study [29] also indicated that factors beyond what could normally be derived from quantitative investigations can be influential in a man's decision to have the PSA test or not.

The lack of consistent outcomes evaluated in the included articles (e.g. decisional conflict, reliable and valid knowledge scales, etc.), inherent differences in the method of delivering information (e.g. verbal vs written vs videotape), lack of UK-based studies and the poor quality of several studies limits the general applicability of the conclusions that can be drawn from this review. The results of this review stress that considerable caution should be exercised when attempting to draw conclusive links between the role of information in improving knowledge in men considering the PSA test and the relationship between information provision and men's intention to have the PSA test.

PSYCHO-SOCIAL IMPLICATIONS OF PSA TESTING

This section of the review will concentrate on the psycho-social implications of prostate cancer screening. The psycho-social effects of the screening process may be divided into five stages:

  • • thinking about requesting screening;
  • • initial effect induced by entering the screening process;
  • • effect linked to the screening act;
  • • effect of waiting for the test results;
  • • effect of receiving the test results (further subdivided into the effects of false-positive results, false-negative results, negative results and true-positive results).

At each stage of the screening process an individual can have a variety of cognitive and emotional reactions. The psycho-social impact of the screening process can have both positive and negative consequences for an individual. In terms of the positive consequences of screening, these can include a feeling of doing something proactive about one's health when entering the screening process, or the feeling of reassurance that occurs when an individual receives a negative result from their screening test. The negative consequences of screening can include anxiety caused by concern about actually engaging in the screening process, or distress from waiting for the test results, or receiving a positive (or false-positive) test result. In terms of the PSA test for prostate cancer, information material available to men should aim to provide enough relevant material to allow an individual to understand the process of screening, therefore reducing the anxiety or uncertainty surrounding the possible outcomes if or when they occur.

Eleven articles on the psycho-social implications of the PSA test or prostate screening were identified from the systematic search. There was some variation in study design, types of outcomes measured and the quality of reporting. Seven of the identified articles primarily concerned the psycho-social impact of prostate screening for asymptomatic men, and four focused on men who were considered to be at higher risk of developing prostate cancer (e.g. family history of prostate cancer, brothers and sons of men diagnosed with prostate cancer). Again, the studies included in this section of the review would not conform to a traditional systematic review, because of differences in the methods and outcomes reported.

OVERVIEW AND RESULTS OF THE PSYCHO-SOCIAL IMPACT STUDIES (ASYMPTOMATIC MEN)

Seven studies investigated the psycho-social impact of prostate cancer screening in asymptomatic men, several of which included men who had a family history of prostate cancer. As part of the Rotterdam prostate-screening programme [47], a longitudinal study was undertaken to examine the changes in health-related quality of life (HRQoL) and anxiety in 626 men undergoing prostate cancer screening. Although some men reported discomfort during the DRE (37%) and TRUS (29%), the mean scores for HRQoL and anxiety indicated that men did not experience changes in either physical, psychological or social functioning during screening. Although men reported higher mean anxiety scores before screening than when they received their test results, the highest mean anxiety score was for men who had a prostate biopsy. However, the authors reported that these scores were not significantly higher than the reference scores for a matched sample of the Dutch population. The authors concluded that prostate cancer screening may be viewed by men as a routine examination, and therefore does not cause significantly large increases in HRQoL or anxiety levels. Also, it was reported that levels of anxiety were higher throughout the screening process for men with a predisposition to being anxious, which may indicate that a subgroup of men could have some detrimental psychological effects caused by prostate cancer screening.

Cantor et al.[48] examined the role of reassurance for prostate cancer screening in primary-care patients. Men were asked to rank three hypothetical screening states by the reassurance value each conferred. These screening states were: (a) unknown (no screening): men do not have the PSA test or DRE to confirm if prostate cancer were present; (b) normal by PSA test and DRE: men have a PSA test and DRE, both tests being normal, confirming that prostate cancer is not present; and (c) normal by biopsy: men had an abnormal PSA and DRE test result, but a negative TRUS biopsy.

Almost all men (96%) reported that they associated some reassurance value with screening. The ‘normal by PSA test and DRE’ (57%) and ‘normal by biopsy’ (38%) states were rated as more favourable by the participants (only 4.2% of men reported that ‘unknown’ was their preferred health state). The preference by men for ‘normal by biopsy’ was associated with a family history of prostate cancer and a perceived greater risk of developing prostate cancer.

A prospective telephone interview study by Taylor et al.[49] determined the impact of screening on psychological distress and men's knowledge about prostate cancer screening; 136 men, who were registered for free prostate cancer screening at two hospitals, were interviewed before screening and after receiving their screening results. The interviews included an assessment of men's screening history, reasons for undergoing screening, cancer-related and general psychological distress, and knowledge of the benefits/limitations of screening. The men rated ‘seeking peace of mind about cancer’ as the most important reason for participating in screening (although the ‘convenience’ of free screening accounted for four of the highest seven reasons for participating). On average, men had a low level of distress before screening and after receiving their results. Indeed, there was no significant change between the intervals in terms of general psychological distress. In comparison to before screening, African-American men and younger men both had significantly lower rates of prostate cancer-related psychological distress after receiving their results.

In terms of benefits and limitations of screening, before screening, 98% of men reported one or more benefits of screening, whereas only 38% reported one or more limitations. After receiving the results of screening, although there were no differences in the perception of benefits, only 22% of men reported a limitation of screening. For the men who had previously reported a limitation, just over a third (37%) again reported a limitation, suggesting the men's recognition of the limitations was diminished after receiving their result. The authors stress the importance of developing informed-consent procedures and educational programmes for asymptomatic men who participate in free programmes, as the man's decision to undergo screening is not based on a full understanding of the current medical knowledge about the benefits and limitations of prostate cancer screening.

A cross-sectional study by Taylor et al.[50] aimed to understand why men attended prostate cancer screening, and to assess the level of psychological distress and perceived risk in men seeking screening; 126 men who attended a free screening programme participated in the study. Fifty-one men with a family history of prostate cancer were compared with 75 with no family history. Self-referral was the most common reason for seeking screening. Contrary to the stated hypothesis, men with a family history were no more distressed (either general or cancer-related distress) than men with no family history. To explore these results, a post hoc analysis revealed that there was a difference between the groups, as men with a family history were more distressed if they also had an higher perceived risk of developing prostate cancer.

Three of the identified studies were primarily concerned with the relationship between psychological variables and physiological outcomes (either the influence of psychological variables directly on PSA levels, or psycho-physiological variables such as serum cortisol). Stone et al.[51] hypothesized that PSA levels were associated with stress (a positive relationship or increased PSA levels) and social support (a negative relationship or decreased PSA levels); 318 men who were involved in a free cancer screening programme participated. Before they had a PSA test and DRE, participants completed the perceived stress scale and a questionnaire assessing satisfaction with social contacts. After controlling for age, men with low stress had lower PSA levels than men with high stress. This was also the same for men with high social support compared to men with low social support. A median-split method indicated that the risk of having an abnormal PSA test was three times higher for men reporting high stress and about double for men reporting low social support. The authors concluded that both perceived stress and social support may be contributory factors to prostate disease.

Another study which hypothesized a relationship between psychological factors and physiological outcomes was that by Cohen et al.[52]. Men's perceived risk of prostate cancer, prostate cancer-specific worry and cancer-related symptoms were assessed to determine if they were associated with PSA levels or DRE findings; 1680 men who were attending annual free prostate cancer screening participated. The statistical analyses indicated that perceived cancer risk, cancer worry and cancer-related symptoms (in conjunction with previously abnormal PSA test and having had a previous prostate biopsy) were significantly associated with an abnormal PSA level. However, when the primary outcome variables were included in the same model, only cancer worry (again in conjunction with a previous abnormal PSA level and a previous biopsy) were associated with an abnormal PSA level (both perceived cancer risk and cancer-related symptoms were discarded from the final model). The authors report that, as hypothesized, all primary outcome variables were individually related to an abnormal PSA level (although there were no interactions among these variables).

A study of Swedish men [53] investigated the possible negative psychological impact of prostate cancer screening (using the PSA test, DRE and TRUS). Both the psycho-physiological (measured by serum cortisol) and psychological (emotional and sleep disturbance questionnaires) reactions of men were assessed. Two groups of men, with no previous history of prostate cancer, were involved in the study. In the initial screening group, 100 men were tested at the time of screening and again 2 weeks later. In the biopsy group, 307 men whose screening result suggested that a biopsy was necessary were tested 2 weeks after screening, but before they were informed of the biopsy results, and again at 4 and 16 weeks. The results of the study indicated that serum cortisol levels were higher before the screening examination than in a comparable sample of similar men (although the comparison group was a historical sample of men from an article published 5 years previously). The highest serum cortisol levels were in men who required biopsy but had not been informed of the result. The cortisol levels in these men decreased 2 weeks after being informed of the result, regardless of whether or not the men were diagnosed with prostate cancer. There were no significant differences between emotional state and sleep disturbance. The authors suggested that the interval between a test and informing the patient should be minimized to decrease the duration of emotional stress.

SUMMARY OF PSYCHO-SOCIAL IMPACT STUDIES (ASYMPTOMATIC MEN)

The results of these articles suggest that HRQoL, psychological distress and anxiety are not dramatically increased during the screening process. Two studies indicated that men had greater distress just before screening and, understandably, when requiring a prostate biopsy [47,53]. Indeed, one study highlighted the need for timely provision of information, as a high level of distress was associated with men who had required a prostate biopsy but had not been informed of the result [53].

The positive psycho-social impacts of screening are not well elucidated in these articles; only one [48] addressed the role of reassurance for men in prostate cancer screening. These results suggest that men, when given the choice, would prefer to know that they did not have prostate cancer, as opposed to not knowing. Indeed, men with a family history of prostate cancer or those who feel that they have a greater risk of developing prostate cancer, are willing to undergo an invasive biopsy to confirm that they do not have prostate cancer. These findings are supported by two studies [49,50] which identified that a high perceived risk of developing prostate cancer was associated with a high level of distress, and that ‘seeking peace of mind about prostate cancer’ was a very important reason for men undergoing screening.

The study by Taylor et al.[49] also investigated men's knowledge about prostate cancer screening, although this was primarily concerned with their reasons for attending screening, and the benefits and limitations of the screening process. The results indicated that men had a reasonable understanding of risk factors associated with developing prostate cancer. Men overwhelmingly reported one or more benefits of screening before attending their appointment, although a staggering 62% were unable to name any limitations of prostate cancer screening. Even fewer men were able to identify these limitations after their appointment, suggesting that the limitations may be less important to men after receiving a negative result. One study [47] suggested that men with a predisposition towards being anxious were more likely to experience negative psycho-social effects of the screening process.

The articles relating to psycho-physiological measures indicated that men were slightly distressed before the screening examination [53] and that there is a possible relationship between stress, perceived risk, prostate cancer worry, social support and high PSA levels [51,52]. Although suggesting an association between psychological processes and physical reactions, these studies show no definitive causal relationship for any effects of psycho-social outcome on PSA levels.

OVERVIEW AND RESULTS OF THE PSYCHO-SOCIAL IMPACT (HIGH-RISK MEN)

Four studies evaluated the psychological effects of screening in high-risk men (e.g. men with a family history of prostate cancer). A series of studies from Sweden on the attitudes towards inherited prostate cancer in sons of men with prostate cancer showed a high interest for PSA and genetic testing in members of this group. The first study [54], which involved 100 unaffected sons of men with prostate cancer, found that 65% definitely wanted to participate in annual screening, and that 60% had worried about their increased risk of developing prostate cancer. The results also indicated that 7% of the men thought that they would worry frequently about developing an interval cancer, 41% thought they would worry, but not frequently, and 40% probably would not worry. The second study [55], which included men from the previous investigation, found that sons of men with prostate cancer had an exaggerated estimate of their personal lifetime risk of developing the disease, and that worry about inheriting prostate cancer affected their daily lives (2% reporting that it affected their daily life ‘fairly much’ and 28%‘slightly’).

Another study by Bratt et al.[56], which included 57 men aged 40–73 years, evaluated the effect of attending PSA testing (and a DRE) in men with a family history of prostate cancer. Concern about prostate cancer, depression and anxiety were assessed at the time of the screening appointment and 4–6 weeks afterward. The results of the questionnaire study suggested that most men with a high hereditary risk of developing prostate cancer did not have severe negative psychological effects from attending prostate screening. However, most men in the study regularly participated in prostate screening, with 63% reporting that they felt either ‘very positive’ or ‘fairly positive’ about their screening visits. Although the men had slightly higher scores on the depression and anxiety questionnaire on the day of the screening visit, the authors indicated that the difference (between the day of visit and 4–6 weeks afterward) was too small to be clinically relevant.

The psychological impact of undergoing the PSA test for high-risk men was reported by Cormier et al.[57]; 220 men who were brothers and sons of men with prostate cancer completed two questionnaires measuring HRQoL and anxiety. The questionnaires were completed at three intervals, i.e. when the men were sent their invitation to attend the PSA test, after the test but before they had received the results, and after they had received their results. Only men who had a normal PSA result (<4 ng/mL) were included in the analysis. The authors reported that there were some negative effects associated with screening, with moderate deterioration in anxiety in ≈ 20% of men and minimal deterioration in HRQoL also in ≈ 20%, between receiving their invitation and receiving the results of the PSA test. The factors associated with a decreased HRQoL included men aged 50–60 years, having more than two relatives with prostate cancer, an anxious personality, a high level of education, and no child living at home. Furthermore, the clinical relevance of these changes was not addressed (it was not reported how many men with increased anxiety also had decreased HRQoL) and may reflect underlying characteristics of the participants rather than the effect of PSA testing.

SUMMARY OF PSYCHO-SOCIAL STUDIES (HIGH-RISK MEN)

An immediate problem for deriving any significant implications of the psycho-social impact of prostate screening for high-risk men is the lack of high-quality studies in this area. Only four articles were identified from the systematic search, which were not UK-based and only two had based their research around an actual screening event. The studies by Bratt et al.[55,56] show clearly that there is a strong interest in men with a family history of prostate cancer to engage in screening behaviour and that, for a small proportion of men, worry about developing the disease has important effects on their daily living.

The results of these studies suggest that high-risk men experience some form of negative psychological reactions before undergoing screening for prostate cancer. However, these negative psychological effects are not severe, and moreover, it is uncertain if these effects represent certain characteristics of men participating in these studies or are caused by the screening process. Providing information material to high-risk men would necessarily be aimed at addressing pertinent concerns that this group has in relation to their specific circumstances, and therefore may not be completely relevant for the content of information material for asymptomatic men.

IMPLICATIONS OF THE PSYCHO-SOCIAL STUDIES

The reviewed articles suggest that there are some psycho-social effects of PSA testing or prostate cancer screening, although these effects are not sufficiently serious to cause deleterious reactions in men. It is unlikely that high-quality, relevant information alone would be influential enough to significantly reduce the anxiety or distress caused by either attending a screening procedure or waiting for the results of the procedure. For example, high-risk men are unlikely to have dramatic decreases in either their perceived risk or worry about developing prostate cancer, without the implementation of a high-quality genetic counselling service which addresses this group's most salient concerns. However, providing information may help men to be aware of the screening process and the possible outcomes of PSA testing, enabling them to be better prepared for the results of the procedure. Further research in this area would be required before any definitive conclusions can be reached. Possibly the most important implication of the review articles is derived from the study by Gustafsson et al.[53], which stresses that the interval between performing the test and receiving the results should be minimized to decrease the duration of distress caused by waiting for the test results.

A serious concern for the quality of published evidence on the psychosocial impact of screening for prostate cancer is the lack of well-conducted (randomized) prospective evaluations. Another concern is that most participants in these studies had previous experience of prostate cancer screening and were either enrolled in free routine screening services or were highly motivated and favourable towards attending periodic prostate cancer screening. Unfortunately, none of the reviewed publications are specific to populations in the UK, which greatly reduces the general applicability of these findings for the British population. Given the lack of well-conducted studies in this area, the conclusions of the reviewed articles should be treated with caution.

One possible reason for not finding clinically relevant psychological effects of attending prostate cancer screening could be related to the type of instruments used in the studies. Most studies used generic self-reported questionnaires (e.g. Hospital Anxiety Depression Scale, Short Form-36, etc.) that were primarily evaluated in populations undergoing far more serious medical procedures. Therefore, the sensitivity of these instruments may not be appropriate for studies in this area. This is similar to the findings for breast cancer screening; it was only with the development of a breast cancer screening-specific instrument, the Psychological Consequences Questionnaire, that the subtle cognitive and emotional reactions that screening has on women undergoing breast screening could be properly evaluated [58,59].

Given the suggestion that men may view prostate screening as a routine procedure [47], coupled with the general lack of knowledge men have in relation to limitations of screening [60], not providing men with high-quality, relevant information about the PSA test and its consequences may suggest that they have been in some way disadvantaged, by not having access to information that may have helped them during or after the screening process.

CONCLUSIONS

The controversy surrounding the utility of opportunistic prostate cancer screening greatly affects the provision of information to men. It is acknowledged by the PCRMP that men will seek PSA testing for several reasons. As shown by several of the organizations providing recommendations for prostate cancer screening, the patient information materials that men receive should enable them to understand both the benefits and limitations of the PSA test, and furthermore the possible future consequences of having the PSA test. This information should also be of a sufficient standard to facilitate discussions between patients and health professionals.

Published research on patient information material indicates that men who receive information have a better knowledge of PSA testing and its consequences than men who receive no or low-quality information. However, the mean difference in knowledge scores between these groups is generally small and based on poor-quality instruments. Given the generally low knowledge scores, it would be very difficult to suggest that this would be representative of informed decision-making (e.g. if men do not achieve high knowledge scores therefore they are not understanding the material to a sufficient extent and cannot be viewed as having made an informed decision). Also, many outcomes that would normally be associated with evaluating informed decision-making materials or the effectiveness of decision-aids (e.g. decisional conflict or satisfaction, etc.) have not been incorporated as primary outcome variables in most reviewed studies.

Although there is a slight reduction in the number of men reporting their intention to have the PSA test after receiving information, no research study has been able to identify why this occurs, nor what information in particular is causing this to happen. The type of screening programme offered will greatly influence men's decision to undergo prostate cancer screening. Information materials which are designed to elicit patient preferences and facilitate a shared decision between the physician and patient (and the patient's significant others) seem to have a greater effect on a man's intention to have a PSA test.

The results of the psychosocial studies suggest that there is no dramatic increase in either distress or anxiety caused by attending prostate cancer screening. However, a significant problem for this area of research is that the instruments used to evaluate the psychosocial impact of prostate cancer screening may lack the sensitivity to detect relevant changes in the emotional or HRQoL of men. The development of prostate-specific measures that can be used to detect smaller changes which directly relate to the PSA test for prostate cancer are required.

Although there have been several high-quality studies of patient information materials and the psychosocial effects of prostate screening, further research is required to clarify:

  • (a) the role that specific information plays in men's decision-making;
  • (b) the most useful way to present probabilistic risk information to men;
  • (c) the type and content of information that both men and health professionals believe is important for men to understand;
  • (d) the most productive way to provide information that can facilitate shared decision-making between patients and health professionals;
  • (e) the positive and negative psychosocial impact information and the screening process has on men.

The lack of high-quality studies in the context of a UK population reduces the applicability of the results of the articles identified from the systematic search. Ongoing research directly evaluating the information materials used for the PCRMP should clarify several issues relating to the information needs of men and the effectiveness of these materials for informed decision-making.

ACKNOWLEDGEMENTS

The authors thank the National Screening Committee for funding this project. The authors also greatly appreciate the comments and help provided by Colleen Bukach on the development and completion of this manuscript.

Appendices

APPENDIX 1

Table 2. Results of the systematic search of the literature.
Core databaseYear/versionDate of searchN records
MedlineWeek 1–3 02/0423/02/04  45
01/2003–01/200423/02/04 455
01/2001–05/200223/02/04 955
01/1999–12/200023/02/04 835
01/1996–12/199823/02/041097
01/1993–12/199523/02/04 683
Total  4070
Embase01/200424/02/04  60
01/2003–12/200324/02/04 642
01/2002–12/200224/02/04 544
01/2001–12/200124/02/04 490
01/2000–12/200024/02/04 379
01/1999–12/199924/02/04 394
01/1998–12/199824/02/04 402
01/1997–12/199724/02/04 315
01/1996–12/199624/02/04 296
01/1995–12/199524/02/04 247
01/1994–12/199424/02/04 253
01/1993–12/199324/02/04 154
Total  4176
CINAHL10/2003–12/200324/02/04  19
01/2002–09/200324/02/04 113
01/2000–12/200124/02/04  89
01/1997–12/199924/02/04 111
01/1982–12/199624/02/04  49
Total   381
PsychInfo01/200424/02/04   7
01/2003–12/200324/02/04  11
01/2002–12/200224/02/04  14
01/2001–12/200124/02/04  12
01/2000–12/200024/02/04  22
01/1999–12/199924/02/04  19
01/1998–12/199824/02/04  13
01/1996–12/199724/02/04  18
01/1993–12/199524/02/04  18
Total   134
AMED1985–01/200424/02/04  47
Total    47
BNI02/2003 Edition24/02/04 102
Total   102
HMIC01/200424/02/04  82
Total    82
Cochrane Library  CDSR (Complete) 24/02/04  84
2004 Version 1CDSR (Protocol)24/02/04  31
DARE24/02/04  40
CCRCT24/02/04 583
CDMR (Complete)24/02/04   1
CMR24/02/04   4
HTA24/02/04  27
NHS EED (CAEE)24/02/04  54
NHS EED (OES)24/02/04  17
Total   841
Overall total  9833

APPENDIX 2

Patient information and psycho-social impact protocol.

BACKGROUND

A request was received from the National Screening Committee and the UK PCRMP to provide an evidence-based document incorporating the latest research related to the early detection and screening of prostate cancer. The CRUK-Primary Care Education Research Group, based at the University of Oxford, provided the second section of the review. The overall aim of this section of the review is to summarize the latest quality research on patient information, informed decision-making and the psycho-social impact of PSA testing.

OBJECTIVES

The primary objective of this section of the review is to identify and report the current evidence base for:

(a) the provision of patient information and informed decision-making for men for the PSA test and its consequences;

(b) the psycho-social implications of PSA testing

Because of the subject area and time considerations, the review is not a traditional systematic review, although it conforms to the standard practices of providing a rigorous systematic search of the healthcare literature, an assessment of the methodological quality and results of the included studies, and a synthesis of the findings.

CRITERIA FOR CONSIDERING STUDIES IN THE REVIEW

The goal of the present review is to establish the current evidence-base for investigations aimed at providing information, decision-making and the psycho-social impact of PSA testing for asymptomatic men. Therefore, the inclusion criteria for the review are particularly broad.

Types of studies: Because of the nature of the review the inclusion criteria are not restricted to a particular type or types of study design.

Types of participants: Men either involved in PSA testing/prostate cancer screening or in research studies of PSA testing/prostate cancer. Studies that directly recruit men who have been diagnosed with prostate cancer would be excluded.

Types of intervention: For the information materials, the types of intervention will include the provision of information materials (either verbal explanations or discussions, written materials, videotape interventions, or multimedia interventions) to men concerning PSA testing. Studies that do not include the provision of patient information to men will be excluded.

Types of outcome measures: For the information materials the primary outcome measures could include knowledge, attitudes, decisional conflict, decision satisfaction, intention to have a PSA test and actual screening behaviour. For the psycho-social impact component the primary outcome measures could include distress, anxiety, depression and quality of life scales. Other measures are expected to be identified as the review progresses.

DATA EXTRACTION

Data were extracted by the reviewers using a standard extraction form. Information on the types of participants, method of recruitment, intervention, data collection procedures and outcomes were extracted.

SEARCH STRATEGY

All medical and healthcare databases were searched from 1993 to the present to identify relevant articles. The search strategy was deliberately broad to ensure that no articles relating to patient information, decision-making or the psycho-social implications of PSA testing were missed. The search strategies used in this section are available from the authors on request.

Ancillary