Medicolegal risk may be reduced if practice is within existing clinical practice guidelines.⁶ Prostate cancer screening represents a "test-case" for such guidelines.⁷ Although there is no evidence that premature mortality from prostate cancer will be reduced by screening (see Box 1), Australian men report high rates of testing.^12,13 GPs use prostate-specific antigen (PSA) assays for screening, either alone or combined with digital rectal examination (DRE).^11,14,15 Current tests cannot distinguish innocuous from aggressive malignancy.¹⁶ Treatment options for men with localised prostate cancer currently available are "unnecessary for some and insufficient for others".¹⁷ On current evidence, men's quality of life may be diminished by anxiety, unnecessary treatment and adverse complications if screening is recommended.¹⁶

Unsurprisingly, 39% of GPs surveyed in 1995 indicated that prostate cancer screening guidelines would be "extremely" or "very" useful.¹⁸ Three sets of guidelines ensued, each recommending against screening.^9,19,20 Yet, Pinnock et al recently reported that there is "anecdotal evidence that general practitioners are concerned that if a PSA test is not offered, and prostate cancer is later diagnosed, they may be seen as negligent".¹³ In a US survey, physicians who perceived that a patient who develops prostate cancer would be successful in suing his physician if he had not been previously screened were more likely to report using PSA tests to screen than those who perceived that such litigation would be unsuccessful.²¹ No published Australian research has quantified the influence of medicolegal concerns on prostate cancer screening. We designed this study to ascertain GPs' perceptions of medicolegal risk when asked to screen for prostate cancer, and, by using case scenarios, to assess the potential impact of national guidelines on their views.

Mr Smith, a 58-year-old employed repairman, presents to his regular GP after prompting by his wife to have a test for prostate cancer. He has no urinary symptoms, no family history of prostate cancer and has not had a vasectomy.

GPs were asked:

• when they had last had a similar request;

• what should be done;

• whether the GP would be at risk medicolegally if she or he either did or did not perform either or both tests for screening purposes;

• what they would do if they were the GP and which test(s) they would advise as being the best available.

We also randomised respondents to receive one of two versions of the case scenario which were identical, except that in one the patient was an architect, and in the other he was a repairman.

We next provided verbatim the policies of the Australian Cancer Society,⁹ the National Health and Medical Research Council (NHMRC)¹⁹ and the Royal Australian College of General Practitioners (RACGP)²⁰ about screening for prostate cancer, and asked if the respondents were aware of each guideline and whether, having read excerpts from all three, they would change their answers to the initial scenario. We then repeated the first scenario and questions.

Our second case scenario read as follows:

Imagine the following scenario with the earlier patient, Mr Smith. Having presented for a PSA test, you discouraged him from having it. Imagine that six months later, he is diagnosed with prostate cancer after a blood test organised by a locum. He then proceeds with a formal complaint against you because you did not do the test when he first requested it.

We asked respondents to indicate if the three guidelines would protect them in the event of such a complaint, the extent to which such a possibility influenced their practice, and their perceptions of the likelihood of such a scenario.

We next asked respondents to indicate their opinion of each of seven statements about prostate cancer screening, using a five-point Likert scale.

Respondents then ranked five current and 14 potential strategies to increase GPs' sense of medicolegal protection in this aspect of clinical practice. The questionnaire concluded with six sociodemographic questions.  

The initial sample size was calculated to yield at least 200 questionnaires for analysis, thereby permitting independent and paired univariate analyses. Descriptive statistics were calculated, using SPSS version 6.0.²² We used univariate analysis to examine differences in GPs' responses to either repairman or architect scenarios. Univariate analysis was also performed to determine significant associations between respondents' beliefs and five nominated outcome variables. For these analyses, categories were collapsed into dichotomous variables. McNemar's ² was used to determine differences in GPs' responses to the scenarios before and after reading the three guidelines.

The Royal Prince Alfred Hospital Ethics Committee approved the study.

More than two-thirds (95% CI, 62.8%-75.0%) of the participating GPs had had a request for prostate cancer screening from an asymptomatic man within the previous week (21.9%; 95% CI, 16.4%-27.4%) or the previous month (47.0%; 95% CI, 39.9%-53.2%). Of the total sample, 52.5% (95% CI, 45.9%-59.1%) indicated that PSA and DRE in combination should be done if a man requested a screening test and 55.3% (95% CI, 48.7%-61.9%) would perform the two tests (Box 2). The proportion of GPs perceiving that the GP would be at medicolegal risk if she or he did not screen for prostate cancer (61.2%) was significantly higher than that perceiving a risk if she or he did screen (15.1%; OR, 0.13; 95% CI, 0.03-0.44; P < 0.001) (Box 3).

Only a quarter of the sample was aware of all three guidelines used in our survey (24.2%; 95% CI, 18.5%-29.9%). After reading the guidelines, significantly more respondents perceived less medicolegal risk if not proceeding to screening (Box 3). In addition, more respondents perceived risk if proceeding to screening (Box 3). Twenty-eight per cent (95% CI, 21.96%-33.8%) indicated that, given the three sets of guidelines, the GP would be protected medicolegally if screening tests were not performed (Box 3).  

Compared with respondents who had stated, after reading the three Australian guidelines, that they would not screen an asymptomatic man, those who had stated they would screen were significantly less likely to indicate that guidelines would protect them medicolegally (OR, 0.08; 95% CI, 0.03-0.19; P < 0.001). Respondents who did not indicate that the GP would be at risk medicolegally if she or he did not perform any screening test were significantly more likely to consider that the guidelines would protect them than those who did (OR, 8.76; 95% CI, 4.45-17.23; P < 0.001).

GPs who had reported that they would change their response to the case scenario after reading the guidelines presented in the survey were significantly more likely to think that the guidelines would protect them compared with those who had reported that they would not (OR, 2.55; 95% CI, 1.34-4.88; P = 0.004).  

Respondents were significantly more likely to agree that a GP could be sued by a patient who subsequently developed prostate cancer for not performing a PSA test than by a patient who subsequently experienced adverse consequences of treatment resulting from a PSA test which had been performed (OR, 2.98; 95% CI, 1.22-8.34; P = 0.01).  

Our proxy for assessing the impact of guidelines on clinical practice augurs poorly for their influence in reducing perceptions of risk of being sued. Although, after reading the guidelines, significantly fewer considered the GP was at risk if she or he did not screen, only 28% indicated the GP was protected medicolegally by three sets of evidence-based guidelines when complying with their recommendations against screening. Even fewer (15%) considered protection would be afforded them if a man, having been diagnosed elsewhere with prostate cancer, then proceeded to initiate legal action for previous failure to screen. Those who perceived such a situation was likely were also more influenced by it in their practice. In contrast, those who would not screen were more likely to feel protected by guidelines.

Most of the respondents supported a clear statement about the legal status of guidelines in a court of law. This is in contrast to the recommendation of a forum held in 1997 to examine legal implications of guidelines.²⁷

Our results also confirm the observation of Pinnock et al that prostate cancer screening can be motivated by medicolegal concerns.¹³ In the US, physicians' self-reported screening correlates with their views about a medical malpractice vignette.²¹ Our findings suggest this to be the case also in Australia, prompting us to agree that "if physicians perform PSA tests at least to some extent out of fear of malpractice, then the standard of care may eventually be set by these defensive practices".²¹ GPs nonetheless support "informed decision-making" by men themselves. Specifically, 88% of the respondents "agreed" or "strongly agreed" that men's decisions to be screened should be based on "full disclosure" of what is known about the diagnosis and treatment of early prostate cancer.

Two methodological caveats are recognised. First, the validity of our use of scenarios before and after exposure to guidelines has not been formally tested against actual behaviour. However, we know of no other feasible method to examine perceptions of medicolegal risk on test-ordering. Second, our response rate (65%) was lower than we had hoped, but the professional and demographic characteristics of our sample were comparable with the NSW GP profile.

In summary, GPs in our survey perceived limited medicolegal protection from evidence-based guidelines. Their lack of confidence in a legal defence based on national guidelines is troubling. Those strategies suggested by GPs as important in increasing their sense of medicolegal protection could be considered further by health departments, medical defence organisations and clinical colleges.

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Australian Institute of Health, Law and Ethics, Sydney, NSW.
Colin J H Thomson, BA, LLM, Executive Officer.

Reprints: Associate Professor J E Ward, Needs Assessment and Health Outcomes Unit, Central Sydney Area Health Service, Locked Bag 8, Newtown, NSW 2042.
jwardATnah.rpa.cs.nsw.gov.au

©MJA 1999
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