Volume 171 Issue 7

Research A South Australian population survey of the ownership of asthma action plans Richard E Ruffin, David Wilson, Anne Marie Southcott, Brian Smith and Robert J Adams MJA 1999; 171: 348-351 Abstract - Introduction - Methods - Results - Discussion - References - Authors' details - - More articles on Respiratory medicine Abstract Objective: To examine the relationships between ownership of written asthma action plans, asthma morbidity, use of devices, and patients' perceptions of their asthma management. Design and setting: A random population survey (in 1996) of the South Australian population aged 15 years or over, using interviewers to administer a questionnaire. Participants: People who reported that they had current, doctor-diagnosed asthma. Main outcome measures: Prevalence of written asthma action plans; night-time awakenings from asthma; ownership of peak flow meters; and people's perceptions of their asthma management. Results: The ownership of asthma action plans by people with self-reported asthma was 33% and has declined since 1995 (42%; P < 0.001). Fifteen per cent were wakened weekly or more frequently by asthma symptoms. These people were more likely to have a peak flow meter and a written action plan, but less likely to consider they had been provided with enough information about their asthma, to feel comfortable managing their asthma, or to find it easy to see their doctor. Having a written asthma action plan was associated with regular corticosteroid use, understanding asthma, having enough information and owning a peak flow meter. Conclusions: Ownership of asthma action plans in South Australia is suboptimal. Before we develop new strategies to improve asthma outcomes, we must determine whether there is a need to target people with less severe asthma and/or improve the use of guidelines by health professionals. Introduction The Australian and New Zealand Asthma Guidelines, developed in 1989, provide a list of objectives that would be desirable to achieve for every person with asthma,1 and studies of the use of asthma management plans have shown improved health outcomes for people with asthma.2-4 In Australia there is evidence that the promotion of asthma plan guidelines by the Thoracic Society of Australia and New Zealand and the National Asthma Campaign has led to increased uptake of plans.1 In South Australia the prevalence of adults with asthma reporting that they had a written action plan almost doubled between 1992 and 1995.5 However, there is evidence that asthma management is not ideal.6-8In one study in Victoria, 45% of people who died of their asthma had been assessed as having only a history of mild or moderate asthma.6 In another study in Victoria that examined the asthma knowledge of asthma patients, the median score obtained was less than 50%.7The effective implementation of asthma management plans in Australia to date has been seriously questioned by some investigators,8 and Bauman et al have concluded that the treatment and management of asthma is suboptimal.9 Our study aimed to provide representative population information on the ownership of written asthma action plans and the relationship to asthma morbidity and management factors. Methods Survey The data for this study were collected in the 1996 South Australian Health Omnibus Survey,10 a representative survey of people aged 15 years or older (n = 3010; response, 71%) . The survey was a multistage, systematic, clustered area sample of people who live in metropolitan Adelaide and major country centres with a population of over 1000. The survey was selected from a random sample of Australian Bureau of Statistics collector districts. Within each collector's district a random starting point was selected and from this point 10 households were selected using a fixed skip interval. Hotels, motels, hospitals, nursing homes and other institutions were excluded. The person whose birthday was next in each selected household was interviewed in their home by trained health interviewers. There was no replacement for non-respondents. Up to five call-backs were made in an attempt to interview the selected person. The data were weighted by age, sex, and geographic region to the estimated resident population data so that the analysis would be representative of the South Australian population. The part of the survey form dealing with asthma is shown in the Box. A person was classified as having current asthma if they answered yes to the first three questions. Social class was determined by referring to the gradation of occupational prestige given in the Australian Standard Classification of Occupations.11 An asthma action plan was defined as "written instructions of what to do if your asthma is out of control." Data analysis Possession of an asthma management plan and frequency of wakening at night with asthma were used as the two dependent variables for univariate analyses,12 which examined the associations between these variables and reported asthma management, knowledge and attitudes to management. Before conducting multiple logistic regression analyses, the explanatory variables were examined for collinearity or interactions. Stratified analyses were used to check homogeneity of associations across different levels of predictor variables. Smoking status and the information that people with asthma perceive they have for dealing with worsening asthma were found to interact, with an effect of these variables on worsening asthma. An interaction term for the two independent variables was included in the logistic regression analysis for frequency of wakening at night. This interaction term proved significant (P = 0.03), indicating the need to split the model and conduct separate logistic regression analyses of smokers and non-smokers. Therefore, we conducted three logistic regression analyses, using "asthma plan", "waken weekly-non-smokers" and "waken weekly-smokers" as the three response variables. All variables found to be significant at the univariate stage (ie, P = 0.25)13 were entered into each logistic regression. Insignificant variables were progressively omitted until satisfactory models were found that explained possession of an asthma plan and frequency of wakening at night. Results The prevalence of asthma was 11.6% (95% CI, 10.3%-12.9%). Of the 349 survey respondents with asthma, 33% (95% CI, 30.8%-35.2%) had a written asthma action plan and 15.2% (95% CI, 13.7%-15.7%) were awakened by asthma weekly or more frequently. Age, sex, migrant status, education level and socioeconomic status made no significant difference to the rate of possession of an asthma action plan or the rate of wakening with asthma weekly or more frequently. Variables significantly associated with ownership of an asthma action plan at the univariate level are shown in Table 1; those significantly associated with wakening with asthma at night are shown in Table 2. In the multivariate analysis (Table 3), the variables that best described those who had an asthma action plan were: using corticosteroids, understanding the effects of worsening asthma, having a peak flow meter, and believing they have enough information to deal with worsening asthma. The variables that best described non-smokers who waken weekly or more often were: having a peak flow meter, having an asthma action plan, not believing they have enough information to deal with worsening asthma, and not feeling comfortable taking care of their asthma. Only one variable -- not finding it easy or convenient to access their doctor about asthma -- explained wakening weekly or more often for smokers. Discussion The data obtained in this representative population study paint a bleak picture of the effectiveness of asthma management in Australia. As even people with mild asthma can die of the disease,6 every person with asthma may need an action plan. Yet, seven years after the promulgation of Australian guidelines on the implementation of asthma action plans,1 only 33% of people with diagnosed asthma had a written plan. The current level of plan ownership is significantly lower than the 42.1% (P < 0.001) reported 12 months earlier using the same survey methods.5 This may mean that vigilance regarding asthma management is declining. Our study has some limitations. We have no objective data to identify levels of asthma severity and asthma control in the respondents. The validity of the perception questions as repeatable measures has not been verified. Because we focused on ownership of written action plans, our study does not tell us whether patients are making appropriate use of these plans or of verbal instructions. In the multivariate analyses, only use of preventer medication, ownership of a peak flow meter and self-reported understanding of asthma were associated with plan ownership. This association could suggest that the more severe cases have better asthma management. Proof for this requires prospective measures (eg, lung function, medication doses) to assess the two critical factors of asthma severity and asthma control. Such knowledge could inform us of the potential need to target people with less severe asthma. People with asthma with nocturnal symptoms were more likely than those without nocturnal symptoms to report possession of a peak flow meter, and to have asthma action plans, but were less likely to consider they had been provided with enough information about their asthma (non-smokers) or to find it easy to see their doctor (smokers) (Table 2). Thus, although asthmatics with a higher level of morbidity are more likely to receive physical materials to assist in self-care, they continue to have greater unmet needs for general practitioner access and information about asthma self-management. What is the way forward? Randomised studies of the implementation of asthma plans show that good educational and skill objectives can be achieved.2,14-16 However, the complexity of the asthma management problem makes it impossible to provide for every contingency the patient might face in dealing with asthma. Asthma management decisions can be difficult, because the patient, the daily situation, the science base and the disease are constantly changing.2 The objectives of patient asthma management are the development of skills and positive attitudes to problem-solving, accompanied by sufficient knowledge to make sense of changing morbidity and symptoms. A controlled trial evaluation of a brief asthma education program (2.5 to 3 hours group work) demonstrated substantial changes in illness behaviour.2 These programs show that giving the patient the necessary skills cannot be achieved within the normal constraints of general practice. Randomised controlled trials of asthma clinics, where there is an emphasis on self-management, have demonstrated improvements in a range of morbidity and other health-related outcomes in a community-based setting.17 We must identify other ways of training the patient and focus the clinician on that part of the education program that can be managed in general practice. There is evidence that regular review improves asthma outcomes.18 It is pertinent to consider the possibility that inadequate use of guidelines by health professionals may be contributing to the fall in action plan ownership. Ways to improve use of guidelines need to include developments in information technology. Trostle has suggested that the inability of some people to comply with a treatment regimen is an unavoidable byproduct of collisions between the clinical world and other competing worlds of work, family, friends and recreation.19 Often, the process required to inform and empower the patient is more than an educational task. Some of the traditional models of patient education based on health beliefs or compliance frameworks have been seriously questioned.20,21 Patients have to fit their medical problems and medical regimens into the context of their daily lives. In doing so they will vary their compliance with advice and instructions to accommodate the social, psychological, economic and physical influences which are part of their lives.21 We need research that clearly articulates the complexity and variability of how asthma management fits into the context of individual patients' lives. The National Asthma Campaign has provided a guide for health professionals to assist with effective patient communication, which is a starting point for corrective strategies.22 We therefore know what optimal management of asthma is, but its attainment is elusive. Future strategies must be guided by studies defining asthma severity and asthma control, studies identifying factors that influence the use of guidelines by professionals, and studies elucidating the context of asthma management for the individual. References Woolcock A, Rubinfeld AR, Seale P, et al. Asthma management plan, 1989. Med J Aust 1989; 151: 650-653. Yoon R, McKenzie DK, Bauman A, Miles DA. Controlled trial evaluation of an asthma program for adults. Thorax 1993; 48: 1110-1116. Comino EJ, Mitchell CA, Bauman A, et al. Asthma management in eastern Australia. Med J Aust 1996; 164: 403-406. Beasley R, Cushley M, Holgate ST. A self-management plan in the treatment of adult asthma. Thorax 1989; 44: 200-204. Adams R, Ruffin R, Wakefield M, et al. Asthma prevalence, morbidity and management practices in South Australia, 1992-1995. Aust N Z J Med 1997; 27: 672-679. Robertson C, Rubinfeld AR, Bowes G. Deaths from asthma in Victoria: a twelve-month survey. Med J Aust 1990; 152: 511-517. Rubinfeld AR, Dunt DR, McLure BG. Do patients understand asthma? A community survey of asthma knowledge. Med J Aust 1988; 149: 526-530. Bauman A, Young L, Peat JK, et al. Asthma under-recognition and under-treatment in an Australian community. Aust N Z J Med 1992; 22: 36-40. Bauman A, Mitchell CA, Henry RL, et al. Asthma morbidity in Australia: an epidemiological study. Med J Aust 1992; 156: 827-831. Wilson D, Wakefield M, Taylor A. The South Australian Health Omnibus Survey. Health Promotional J Aust 1992; 2: 47-49. Kelley JL, Evans MDR. Using ASCO for socio-economic analysis: assessment and conversion into status and prestige indices. Canberra: Research School of Social Sciences, Australian National University, 1988. SPSS for Windows. Release 8.0 [computer program]. Chicago, IL: SPSS Inc, 1998. Hosmer DW, Lemeshow S. Applied logistic regression. New York: John Wiley, 1989. Wilson-Pessano SR, McNabb WL. The role of patient education in the management of childhood asthma. Prev Med 1985; 14: 670-687. Clark NM, Feldman CH, Evans D, et al. Managing better: children, parents and asthma. Patient Educ Counsell 1986; 8: 27-38. D'Sousa WD, Crane J, Burgess C, et al. Community-based asthma care: trial of a "credit card" asthma self-management plan. Eur Respir J 1994; 7: 1260-1265. Lahdenso A, Haajtela T, Herrala J, et al. Randomised comparison of guided self-management and traditional treatment of asthma over one year. BMJ 1996; 312: 748-752. Asthma management handbook 1998. Melbourne: National Asthma Campaign, 1998. Trostle JA. Medical compliance as an ideology. Soc Sci Med 1988; 18: 1299-1308. Carter WB. Psychology and decision making: modelling health behaviour with multiattribute theory. J Dental Educ 1992, December: 800-807. Morris SL, Schulz RM. Medication compliance: the patients' perspective. Clin Ther 1993; 15: 593-606. Asthma adherence: a guide for health professionals. Melbourne: National Asthma Campaign, 1999. (Received 19 Apr, accepted 26 Aug, 1999) Authors' details The Queen Elizabeth Hospital, Adelaide, SA. Richard E Ruffin, FRACP, MD, Head, Division of Medicine, and Michell Professor of Medicine, University of Adelaide; Anne Marie Southcott, MB BS(Hons), FRACP, Acting Director, Respiratory Medicine; Brian Smith, PhD, FRACP, Director, Clinical Epidemiology and Health Outcomes Unit, and Senior Lecturer, University of Adelaide. Centre for Population Studies in Epidemiology, Department of Human Services, Adelaide, SA. David Wilson, PhD, MPH, Head. Channing Laboratory, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Robert J Adams, MB BS, FRACP, Research Fellow. Reprints: Professor R E Ruffin, Department of Medicine, University of Adelaide, The Queen Elizabeth Hospital Campus, 28 Woodville Road, Woodville, SA 5011. rruffinATmedicine.adelaide.edu.au Survey questions Have you ever had asthma? Was your asthma confirmed by a doctor? Do you still have asthma? If answer yes to these questions, then: Do you have an asthma action plan (written instructions of what to do if your asthma is out of control)? Do you have a home nebuliser for asthma treatment? Interviewer: if "yes" prompt "have you used it in the last 12 months?" What preventive (not reliever) medicine do you use regularly for your asthma? None - Intal - Becotide - Becloforte Pulmicort - Tilade - Other (specify) Which of the statements shown on this card do you feel are true of your preventer medication? Works by relieving narrowed breathing tubes quickly Needs to be used when you feel unwell Works by slowly reducing inflammation in the breathing tubes Must not have the dose changed Don't know How often do you awaken during the night with asthma? Nightly - Most nights - About twice a week - Weekly - Monthly - Less often than monthly Only at certain times of the year (ie seasonal) Never In the last 12 months have you had any hospital admissions for asthma where you stayed at least one night in hospital? In the last 12 months have you had any days lost from work, school or home duties from asthma? How many days would you estimate? What would you do if you had a bad attack of asthma and six puffs of your reliever (eg, ventolin, respolin) had not helped? Which of these statements shown on this card most closely matches what you would be likely to do? Wait another two hours and take more reliever medication Seek medical advice Take another six puffs of reliever medication and see what happens Call an ambulance Get someone to take you to hospital Do something else (specify) What feelings would you have if you had to get help for a bad attack of asthma? Which of the statements shown on this card most closely match how you would be feeling? You feel that you have failed You would feel embarrassed You do not want to bother others It is the right thing to do You know you will be OK because of past experience Something else (specify) I am now going to read out a number of statements and show you a card for each of them. Could you please tell me which number from 1 to 5 best reflects the way you feel. I am the sort of person who understands all about my asthma Always - Often - Sometimes - Rarely - Never - Don't know/other If I took care of my asthma myself, most of the time, I would . . . Manage well Manage sometimes Not manage at all Don't know/other If I were having a severe attack of asthma I would feel comfortable about going to a doctor or hospital Very comfortable Comfortable Don't mind Uncomfortable Not comfortable at all Don't know/other Going to see a doctor for help with my asthma is Easy and convenient Not easy nor convenient Don't know/other I have information to use (such as "Asthma Action Plan" or other instructions) to deal with worsening asthma. Yes, all I need Some No, none at all Don't know/other Other questions were asked about smoking status, educational level and migrant status. Back to text 1: Variables associated with ownership of an action plan*VariableSubjects (n = 349)%Odds ratioWrong about CS effect10332.01.0Correct about CS effect162†44.41.7 (0.98-2.94) P = 0.04Don't use CS regularly14721.81.0Use CS regularly20241.62.56 (1.54-4.26) P < 0.01No home nebuliser28229.11.0Have home nebuliser6750.72.51 (1.41-4.48) P < 0.01No peak flow meter29626.61.0Have peak flow meter5371.76.99 (3.50-14.14) P <0.01Don't always understand asthma8516.51.0Understand asthma26438.63.19 (1.65-6.27) P < 0.01Not enough information11715.51.0Enough information23255.56.77 (3.98-11.56) P <0.01Feel bad getting help4721.31.0Getting help OK30235.12.26 (1.04-4.90) P = 0.04No hospital admission within 12 months 33432.1 1.0Hospital admission1560.03.17 (1.00-10.32) P = 0.05No days lost from work/school30231.11.0Days lost from work/school4746.81.95 (1.00-3.79) P = 0.05CS = corticosteroids. * Variables tested but not found to be significant were: sex, age, migrant status, educational level, socioeconomic status, weight, access to doctor, uncomfortableness dealing with asthma, perception of dealing with asthma, comfortableness in going to hospital if required, exercise, smoking status, and smoking bans at home. †Only those who regularly used preventive medicine for their asthma (n = 265) were asked about its effects. Back to text 2: Variables associated with the likelihood of wakening with asthma on a weekly basis or more frequently*VariableSubjects (n = 349)%Odds ratioWrong about CS effect1038.71.0Correct about CS effect162†25.83.63(1.60-8.45) P < 0.01No home nebuliser28212.81.0Have home nebuliser6730.81.96 (0.96-3.95) P = 0.04No peak flow meter29612.81.0Have peak flow meter5330.83.02 (1.45-6.27) P < 0.01Not easy to see doctor6033.31.0Easy access to doctor28911.80.27 (0.13-0.53) P < 0.01Uncomfortable taking care of asthma 4836.2 1.0Comfortable taking care30112.30.25 (0.12-0.52) P < 0.01Perception of self-management good 3813.7 1.0Perception poor31129.42.62 (1.09-6.25) P = 0.0 3No days lost from work/school30213.61.0Days lost from work/school4727.72.42 (1.11-5.25) P = 0.02CS = Corticosteroids. * Variables tested but not found to be significant were: sex, age, migrant status, educational level, socioeconomic status, weight, regular use of corticosteroids, not always understanding asthma, not having enough information, feeling bad getting help, comfortableness in going to hospital if required, exercise, smoking status, smoking bans at home, and having an asthma action plan. †Only those who regularly used preventive medicine for their asthma (n = 265) were asked about its effects. Back to text 3: Logistic regression analyses of variables associated with ownership of an asthma management plan and frequency of wakening at night with asthma (n = 349)VariableOdds ratioAsthma planNo peak flow meter1.0Have peak flow meter4.32 (2.91-8.43)Don't always understand asthma 1.0Understand asthma2.01 (1.01-4.02)Not enough information1.0Enough information4.32 (2.11-8.85)Don't use corticosteroid regularly1.0Use corticosteroid regularly2.08 (1.21-3.58)Waken weekly (non-smokers)No peak flow meter1.0Have a peak flow meter7.32 (2.59-20.07)Not enough information1.0Enough information0.12 (0.04-0.39)Uncomfortable taking care of asthma1.0Comfortable taking care0.30 (0.14-0.77)No asthma action plan1.0Asthma action plan2.79 (1.09-7.15)Waken weekly (smokers)Not easy to see doctor1.0Easy to see doctor0.28 (0.10-0.79)All results significant, P < 0.05. Back to text

Richard E Ruffin · David Wilson · Brian Smith · Robert J Adams

Research Erectile dysfunction in the community: a prevalence study Carole B Pinnock, Alan M F Stapleton and Villis R Marshall MJA 1999; 171: 353-357 For editorial comment see Lowy Abstract - Introduction - Methods - Results - Discussion - Acknowledgements - References - Authors' details - - More articles on Urology Abstract Objective: To investigate the prevalence of erectile dysfunction (ED) in the South Australian community, and the influence of demographic and other risk factors. Design: Survey by mailed questionnaire (based on the University of California, Los Angeles prostate cancer index) of a subset (men who agreed to participate) of a probability sample of the South Australian community who completed a multiuser interview survey. Participants and setting: Men over the age of 40 in South Australia. Main outcome measures: Sexual desire, orgasm, ability to have an erection, adequacy (firmness) of erections for intercourse, frequency of erections when wanted, frequency of intercourse, nocturnal or morning erections, and history of prostate surgery; total sexual function score based on these. Results: 612 men (86.7%) agreed to answer the sexual function survey; 427 (69.8%) returned questionnaires. ED was strongly correlated with age in all seven domains of sexual function. Erections inadequate for intercourse affected 3% of 40-49-year-olds, increasing to 64% of 70-79-year-olds. The frequency of intercourse considered normal for age by men 50-69 years was 1-6 times weekly; the disparity between this and reported frequency increased in men over 60 years, as did the difference between sexual desire and potency. A history of vigorous exercise was protective across all ages. High triglyceride levels, blood pressure medication and non-cancer surgery for prostate disease were independent predictors of poor sexual function at older ages. High cholesterol level was an independent predictor of impotence. Conclusions: We found similar or higher levels of ED than in comparable overseas studies. Disparity between potency and desire was greatest, and hence the age group in whom demand for treatment may be highest, in those 60 years and older. Cardiovascular risk factors were predictors of ED in these older men, suggesting that prevention may benefit sexual function. Non-cancer prostate surgery may be a greater contributor to ED than previously realised. Introduction Establishing the prevalence of erectile dysfunction (ED) in the community is difficult,1 but important for understanding the need for services, establishing functional expectations of men as they age and for determining the influence of demographic and preventable risk factors. An understanding of community prevalence of ED is useful when evaluating treatments for prostate disease which carry high risks of ED. Community prevalence has been examined in international, but not Australian, studies.1-4 One Australian study of ED prevalence in a Perth general practice population has been reported in conference proceedings.5 We undertook this study to establish the prevalence of erectile dysfunction among Australian men, and to investigate the influence of risk factors. Methods Questions were included in the spring 1997 Omnibus survey, a multiple-user household interview survey which provides a representative sample of the South Australian population. We have reported the methods of and results from this annual survey previously.6-8 The Omnibus survey included questions about age, educational attainment, marital status, household income, area of residence, blood pressure group (low, normal, borderline, high), cholesterol group (low, normal, high), alcohol intake by frequency (days per week) and volume (standard drinks per day when drinking), doctor's report of high triglyceride levels, body mass index (BMI), whether vigorous exercise was undertaken in the past two weeks, current and previous smoking status, and number of cigarettes per day usually smoked. Also included were questions about the presence of lower urinary tract symptoms (LUTS) such as nocturia, frequency, urgency, and a visit to a doctor for LUTS, as reported previously.6 In addition, men aged 40 years and over were asked if they would be prepared to answer a further, mailed questionnaire on urological issues. This comprised an introductory letter explaining the purpose of the survey,7 questions on sexual function and one on history of prostate surgery. To provide an indication of men's expectations of intercourse frequency across age groups, the first question asked what frequency of intercourse the respondent considered normal for a man of his age. Respondents were then offered the opportunity to return the questionnaire without answering further questions if they considered these too intrusive. Sexual function questions were derived from the UCLA (University of California, Los Angeles) prostate cancer index developed by Litwin et al.9,10 These applied to the previous three months and covered seven domains: (i) sexual desire, (ii) orgasm, (iii) ability to have an erection, (iv) frequency of erections when wanted, (v) frequency of intercourse, (vi) frequency of morning or nocturnal erections, and (vii) firmness of erections. The first six of these had five response options ("nil", "poor", "fair", "good", "very good" for domains i-iii; "never had an erection when I wanted one", "less than half the time when I wanted one", "about half the time I wanted one", "whenever I wanted one" for domain iv; "once or more daily", "1-6 times weekly", "1-3 times monthly", "less than once a month", "not at all" for domain v; "never", "seldom [less than a quarter of the time]", "not often [less than half the time]", "often [more than half the time]", "very often [more than 75% of the time]" for domain vi), while the seventh had four ("no erections at all", "not firm enough for any sexual activity", "firm enough for masturbation and foreplay only", "firm enough for intercourse"). Additional questions involved history of prostate surgery (for cancer and for non-cancerous conditions). Ethical consideration for the study was by Repatriation General Hospital's Research Ethics Committee. Analysis We defined sexual dysfunction as a response of one of the two lowest response categories (eg, "nil" or "poor") in each of the first six domains. Confidence intervals were adjusted for a design effect of 1.1 to allow for clustering.11 Dysfunction in the seventh domain (firmness of erections) was termed "impotence", defined as "usual quality of erections during the past three months not firm enough for intercourse" (corresponds with National Institutes of Health definition)12 -- one of the three lowest response options for this domain. A total erectile function score was derived by adding scores for each of the seven domains. The resulting score out of a possible 34 was expressed as a percentage; a score of 0 indicated worst possible function and 100% indicated best possible function in all domains. The reliability coefficient (Cronbach's alpha) of this seven-item score was 0.940. The association of demographic and cardiovascular risk factors with total sexual function (expressed as a continuous variable) and with impotence (a dichotomous variable) was examined after allowing for the effects of age by means of analysis of variance and logistic regression. For analysis, data were weighted by household size, age, sex and geographic region to benchmarks derived from the resident South Australian population in August 1996. We used SPSS for Windows13 for statistical analysis. Results The numbers and age breakdown of respondents are shown in Box 1. The mean age of respondents was 57.5 years (standard error, 0.58). Of the 745 men aged 40 years and over who responded to the Omnibus survey (representing a response rate of 70.8%), 612 (82.1%) agreed to complete a further, mailed questionnaire on urological issues. These questionnaires were returned by 427 respondents (69.8%), 371 (86.9%) of whom agreed to answer the full questionnaire. Box 1 shows that the age distribution was the same in all of these groups. We weighted further analyses to reflect the age distribution in the South Australian community; marginal totals thus do not correspond to the totals in Box 1. A comparison of respondents who agreed to answer the sexual function questions with those who did not agree to a further survey, did not respond to the mailed form or did not agree to answer the sexual function questions showed no significant differences in age, marital status, blood pressure, cholesterol and triglyceride levels, blood pressure medication or visit to a doctor for LUTS. Men who answered the sexual function questions were more likely to report vigorous exercise in the past two weeks (25.0% v 15.4%; P = 0.001), and more likely to drink alcohol five or more times per week (34.2% v 25.3%; P = 0.026) than those who did not answer these questions. Frequency of intercourse The frequency of intercourse considered by respondents as normal for their age, shown in Box 2(a), and actual reported frequency of intercourse were strongly correlated (Spearman's correlation coefficient, 0.62; P < 0.0001). Most 40-60-year-olds considered that intercourse 1-6 times per week was normal for their age and most reported this frequency of intercourse. In older men, however, a discrepancy emerged: most 70-79-year-olds considered 1-3 times per month to be normal for their age, but most reported an actual frequency of less than once per month. Box 2(b) illustrates this more clearly. In younger age groups, the reported frequency approximated that considered normal for age, but in older age groups it was substantially lower. Similarly, Box 2(c) shows that, while potency exceeds desire in men aged 40-59 years, after age 60 years desire exceeds potency. Prevalence of erectile dysfunction Erectile dysfunction was strongly correlated with age across all seven domains (Box 3). The prevalence of impotence (defined above) increased sharply from 3% in 40-49-year-olds to 42% in 60-69-year-olds and 64% in 70-79-year-olds. Other domains of sexual function, including morning or nocturnal erections, followed this pattern of steep decline in the fifth and sixth decades. Total sexual function scores ranged from 17% to 97%, with a mean of 68.1% (standard error, 1.1); 21% of respondents had a score of 50% or less. The sexual function score was also strongly correlated with age (Pearson's correlation coefficient, 0.63; P < 0.0001). Demographic risk factors Age, income, education, marital status, area of residence, occupation and country of birth were examined for their association with total sexual function and impotence. By far the strongest contributor to total sexual function score was age, and so the contribution of other factors was examined singly after first accounting for the effects of age in analysis of variance models, including first-order interactions (sexual function) and logistic regression (impotence). Where factors or their first-order interactions were significant, a combined model was examined. A summary of these analyses is given in Box 4. Men with lower socioeconomic status (income, education, occupation) tended to have lower sexual function, and this association was seen particularly in older men. In the 70-79 years age group, the total sexual function score varied from 47.1 in the lowest education category to 61.7 in the highest. Sexual function tended to be lower in Australian-born than overseas-born respondents. When tested in a model containing cardiovascular risk factors, this association remained. No demographic factors, apart from age, were significant contributors to impotence. Cardiovascular and other risk factors The cardiovascular risk factors shown in Box 4, as well as presence of LUTS, doctor visit for LUTS and surgery for prostate disease (cancer or non-cancer), were examined for their effects on total sexual function and impotence, as described for demographic factors. A number of factors were significantly (P < 0.05) associated with decreased sexual function after controlling for the effects of age. For total sexual function, these were ever having smoked, taking blood pressure medication and having had surgery for non-cancer prostate disease. A history of vigorous exercise was protective. Risk factors for impotence were high body mass index, high levels of triglycerides and cholesterol, and surgery for non-cancer prostate disease. Again, a history of vigorous exercise was protective. When combined models were constructed with these factors, the number that remained independently significant was reduced (Box 4). For total sexual function, these were vigorous exercise, high triglyceride levels, blood pressure medication, and surgery for non-cancer prostate disease. The combined model for total sexual function explained 55% of the variance. The observed power was low for all non-significant factors. The effects of cardiovascular risk factors were stronger in older age groups. For example, men in their 60s with high triglyceride levels had a total sexual function score of 41% (95% CI, 31%-52%), compared with 64% (95% CI, 59%-70%) for men of the same age who did not have this risk factor. Discussion Few international or Australian studies of the prevalence of sexual dysfunction have surveyed the general community.1 Our study was based on a representative sample of the South Australian community, and employed rigorous methods which have been previously used in other prevalence studies.1,8 The study was undertaken before the recent introduction of the drug oral sildenafil for erectile dysfunction. The subsample who answered questions on sexual function were similar in terms of most demographic and risk factor variables tested, but did report undertaking more vigorous exercise, and more frequent alcohol consumption. They may therefore reflect a more physically active subgroup, and our estimates of erectile dysfunction are likely to be conservative. Relative to other studies with comparable methods and measures of sexual dysfunction, the prevalences we found were similar or higher. For example, a study of frequency of sexual activity reported that 34.7% of married 60-65-year-old people did not have sexual intercourse within the preceding month,14 while we found that 34.3% of 60-69-year-old men reported having intercourse "less than once a month". A survey of 1240 men attending general practices in Perth found a 45% prevalence of "complete ED [erectile dysfunction]" in 70-79-year-old men,5 compared with our finding of impotence in 64.2%, and 64.3% in a study by Diokno et al.15 The frequently quoted Massachusetts Male Aging Study reports a prevalence of complete impotence of 9.6% for a 40-70-year-old population;2 the corresponding figure in our study was 16%. As expected, frequency of intercourse considered normal for age was strongly correlated with the frequency of intercourse reported (Figure 2). Solstad and Hertoft found that, while 40% of interviewed Danish men reported some kind of sexual dysfunction, only 7% considered their problems abnormal for their age,16 implying that men tend to see their own functional level as normal. Nevertheless, in our study, the discrepancy between reported frequency of intercourse and that considered normal for age increased with age. It was greatest in men 70 years and older, suggesting that it is older men who may be most concerned about their sexual function. Consistent with this, potency exceeded desire in younger age groups, but the relationship was reversed in men aged 60 years and over. About one in five men over the age of 50 experience good to very good sexual desire, but nil to poor erectile function; these men may be more likely to seek treatment. If the goal of treatment is to achieve perceived "normal function for this age", this may be a frequency of intercourse of 1-3 times monthly for 70-79-year-olds and weekly in the case of 40-69-year-olds. The effects of demographic risk factors such as income and education were more apparent in older age groups and were consistent with lower sexual function in lower socioeconomic groups. No reason is immediately apparent for the lower sexual function of Australian-born men compared with their overseas-born counterparts. Cardiovascular and medical risk factors reflected a conventional pattern.1,17 Predictors of low total sexual function scores after controlling for age only were smoking, blood pressure medication, high triglyceride levels and non-cancer prostate surgery, while a history of vigorous exercise provided a protective effect. In a combined model, smoking was no longer significant. Predictors of impotence after controlling for age only were high body mass index, high triglyceride levels, high cholesterol level, surgery for non-cancer prostate disease, while vigorous exercise was again protective. In a combined model, only high cholesterol remained significant. However, it is likely that small numbers of respondents limited the power of our study to investigate all these factors simultaneously. Our findings suggest that men experience poor sexual function as a deficit in the same age ranges in which cardiovascular risk factors are major determinants of that function, raising the possibility of prevention. It would be interesting to know whether, for men 60 years and over, improving cardiovascular risk factor profile would also reduce the prevalence of sexual dysfunction. Also of interest is the consistent and independent effect of non-cancer prostate surgery on sexual function. While its effects are small relative to age, it may point to a higher impotence rate than is commonly believed to result from this type of surgery,18 and this warrants further investigation. Acknowledgements We thank Living Health and Quitline for generously sharing their data on cardiovascular risk factors, and the AntiCancer Foundation for funding the prostate cancer questions. We would also like to thank the Behavioural Epidemiology Unit, South Australian Department of Human Services, and Lynne Giles, Flinders University, for assistance with aspects of the statistical analyses. References Bortolotti A, Parazzini F, Colli E, Landoni M. The epidemiology of erectile dysfunction and its risk factors. Int J Androl 1997; 20: 323-334. Feldman HA, Goldstein I, Hatzichristou DG, et al. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol 1994; 151: 54-61. Helgason AR, Adolfsson J, Dickman P, et al. Factors associated with waning sexual function among elderly men and prostate cancer patients. J Urol 1997; 158: 155-159. Jonler M, Moon T, Brannan W, et al. The effect of age, ethnicity and geographical location on impotence and quality of life. Br J Urol 1995; 75: 651-655. Chew K, Burio C, Stuckey B, Jamrozik K. Erectile dysfunction in general medical practice. A study in Perth, Australia. Int J Impotence Res 1997; 9 (Suppl 1): S36. Pinnock C, Marshall V. Troublesome urinary symptoms in the community: a prevalence study. Med J Aust 1997; 167: 72-75. Weller D, Pinnock C, Silagy C, et al. Prostate cancer testing in South Australian men: influence of sociodemographic factors, health beliefs and lower urinary tract symptoms. Aust N Z J Public Health 1998; 22: 400-402. Pinnock C, Weller D, Marshall V. Self-reported prevalence of prostate specific antigen (PSA) testing in South Australia: a community study. Med J Aust 1998; 169: 25-28. Litwin MS, Hays RD, Fink A, et al. Quality-of-life outcomes in men treated for localized prostate cancer. JAMA 1995; 273(2): 129-35. [See comments.] Litwin MS, Nied RJ, Dhanani N. Health-related quality of life in men with erectile dysfunction. J General Intern Med 1998; 13: 159-166. Kish L. Estimates of unit variance: design effect. Survey sampling. New York: John Wiley and Sons, 1965: 257-263. NIH Consensus Conference. Impotence. NIH Consensus Development Panel on Impotence. JAMA 1993; 270: 83-88. SPSS for Windows [computer program], version 6.1. Chicago, Ill: SPSS Inc, 1996. Marsiglio W, Donnelly D. Sexual relations in later life: a national study of married persons. J Gerontol 1991; 46(6): S338-S344. Diokno AC, Brown MB, Herzog AR. Sexual function in the elderly. Arch Intern Med 1990; 150: 197-200. Solstad K, Hertoft P. Frequency of sexual problems and sexual dysfunction in middle-aged Danish men. Arch Sexual Behavior 1993; 22: 51-58. Helgason AR, Adolfsson J, Dickman P, et al. Waning sexual function -- the most important disease-specific distress for patients with prostate cancer. Br J Cancer 1996; 73: 1417-1421. Clinical practice guidelines for the management of uncomplicated lower urinary tract symptoms in men. Canberra: National Health and Medical Research Council, 1997. (Received 30 Nov 1998, accepted 28 Jun 1999) Authors' details Repatriation General Hospital, Daw Park, Adelaide, SA. Carole B Pinnock, PhD, Principal Research Scientist, Division of Surgery; Alan M F Stapleton, PhD, FRACS, Director, Urology Unit; Villis R Marshall, MD, FRACS, Head, Division of Surgery, and Head, Department of Surgery, Flinders Medical Centre. Reprints will not be available from the authors. Correspondence: Dr C B Pinnock, Division of Surgery, Repatriation General Hospital, Daws Road, Daw Park, SA 5041. carole.pinnockAThealth.sa.gov.au Back to text Back to text Back to text Back to text

Carole B Pinnock · Villis R Marshall

Abstract Objective: To ascertain general practitioners' perceptions of medicolegal risk when screening for prostate cancer, and explore the potential impact of three national guidelines on perceptions and clinical practice. Design: Postal survey in August 1997. Participants: 219 randomly selected GPs in New South Wales (65% response rate). Main outcome measures: Response to case scenarios; perceptions of medicolegal risk and protection afforded by national guidelines before and after reading extracts of three national guidelines; ratings of current and potential strategies to increase GPs' sense of medicolegal protection. Results: 90% (95% CI, 86.5%-94.3%) would screen an asymptomatic male patient and 61% (95% CI, 54.2%-67.2%) indicated GPs would be at risk if they did not screen. Although significant changes in responses were found after respondents had read guideline extracts, 46% (95% CI, 39.5%-52.7%) continued to perceive medicolegal risk if screening was not performed. About two-thirds (65%; 95% CI, 59.9%-72.5%) supported a clear statement about the legal status of guidelines in a court of law to increase their sense of medicolegal protection. Conclusions: Even when made aware of national evidence-based guidelines against prostate cancer screening, GPs in our survey perceived limited hypothetical medicolegal protection. Introduction In Australia, the risk of medical litigation has increased. For general practitioners, the risk of being sued doubled from 1:160 in 1990 to 1:84 in 1994.1 If doctors believe these risks are substantial, this belief alone may influence their clinical behaviour.2-5Medicolegal 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. Methods Questionnaire The first section of our self-administered questionnaire commenced with this case scenario: 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. Survey administration and analysis We purchased a list of all NSW GPs from a commercial company and randomly selected 400 names. Questionnaires and reply-paid envelopes were mailed in mid-1997, after an advance telephone prompt. At Day 16, non-responders received a reminder letter. At Day 35, a second questionnaire was posted to remaining non-responders. Two weeks after the second mail-out, a research assistant telephoned any remaining non-responders. 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 χ2 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. Results Of the 400 randomly selected GPs, 64 were ineligible (2 dead, 9 retired, 25 not in general practice, 5 on extended leave, 8 outside Australia, 15 uncontactable). From the 336 eligible GPs, 219 (65%) usable questionnaires were received. Our sample comprised 161 male respondents (74%) and 55 female respondents (26%), compared with 68% and 32%, respectively, for the NSW reference sample.23 Median age of our respondents was 47 years (range, 28-70 years); half had been in general practice for more than 17 years (range, 1-47 years) and 127 (58%) worked in the Sydney metropolitan area, somewhat comparable with the NSW reference sample (51% aged 45 years or over and 70% practising in Sydney).23 As only proportions (not actual numbers) for the NSW sample have been published,23 statistical testing of response bias was precluded. Responses to Scenario 1 Of the 219 GPs, 116 (53%) had received the repairman version of the case scenario and 103 (47%), the architect. There was no significant difference in GPs' answers to management of a patient's request for screening before (odds ratio [OR], 0.6; 95% CI, 0.19-1.85; P = 0.4) or after (OR, 0.79; 95% CI, 0.38-1.63; P = 0.5) reading the guidelines. Responses to all scenarios were therefore combined irrespective of patient occupation. 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). Responses to Scenario 2 In the second case scenario, 14.6% (95% CI, 9.92%-19.3%) of respondents thought that the three guidelines would "most likely" protect them in the event of such a complaint. Respondents who thought such a scenario would "most likely" or "likely" influence their practice (68.9%; 95% CI, 62.8%-75.0%) were significantly more likely than those indicating it "unlikely" (23.7%; 95% CI, 18.1%-29.3%) to consider such a scenario could happen (OR, 2.72; 95% CI, 1.48-5.0; P = 0.0001). 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). GPs' views about influences on prostate cancer screening Box 4 summarises responses to seven statements about prostate cancer screening in general practice. Of the sample, 87.2% (95% CI, 82.8%-91.6%) "strongly agreed" or "agreed" that patients' decisions to be screened should be based on full disclosure of what is known about diagnosis and treatment of early prostate cancer. 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). GPs' views of strategies to increase their sense of medicolegal protection In rating five current strategies to increase their sense of medicolegal protection, 50% (95% CI, 43.6%-56.8%) of respondents considered guidelines based on systematic reviews of the evidence as "very important", followed by NHMRC endorsement (44%; 95% CI, 37.2%-50.3%), quality of patient information (44%; 95% CI, 37.2%-50.3%) and availability of patient information about prostate cancer screening (38%; 95% CI, 31.96%-44.8%). A minority (11%; 95% CI, 6.9%-15.1%) were unsure of the impact of the current adversarial court system, which is seen as adversarial rather than conciliatory. With regard to potential strategies, there was strong support for written advice about the legal status of guidelines and inviting GP peers as well as specialists as expert witnesses in court (Box 5). Discussion Evidence-based guidelines appear to have little influence on GPs confronted by an asymptomatic man requesting prostate cancer screening. At least 90% of respondents in our study would proceed with at least one screening test (DRE, PSA, or both in combination). Furthermore, a significant majority of respondents considered the GP in the first scenario would be "at risk" medicolegally if she or he did not screen, and more so than if she or he did screen. Awareness of national guidelines was low. Surveys repeatedly demonstrate poor penetration of guidelines into general practice,24 generating interest in more deliberate implementation.7,25,26Our 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. Acknowledgements The study was conducted while S Girgis was completing the NSW Health Department Public Health Officer Training Program. We thank Geoff Hirst for advice; Drs Buhagier, Stan, Gordon, Foran, Reid, Young, McGuigan and Sladden for their comments as GPs on questionnaire drafts; Nancy Harding for research support; Margaret Lesjak for assisting with telephone prompts; and Neil Donnelly for statistical advice. References Keaney MA. Is there a medical litigation crisis? Individual viewpoints on the perceived medical litigation crisis. Is litigation increasing? Med J Aust 1996; 164: 178-179. Weisman C, Morlock L, Teitelbaum M, et al. Practice changes in response to maplractice litigation climate. Results of a Maryland physician survey. Med Care 1989; 27: 16-24. Kessler D, McClellan. Do doctors practice defensive medicine? National Bureau of Economic Research working paper series. Cambridge, 1996. Summerton N. Positive and negative factors in defensive medicine: a questionnaire study of general practitioners. BMJ 1995; 310: 27-29. Hancock L. Defensive medicine and informed consent: a research paper. Review of professional indemnity arrangements for health care professionals. Canberra: AGPS, 1993. Barratt A, Bates P. O tell me the truth about evidence. Aust N Z J Public Health 1997; 21: 441-444. Ward J. Prostate cancer screening: too much, too soon? Cancer Forum 1998; 22: 18-23. Report of the US Preventive Services Task Force. Guide to clinical preventive services. 2nd ed. Baltimore: Williams & Wilkins, 1996; xlii. Australian Cancer Society. Prostate cancer screening: guidelines for health professionals. Cancer Forum 1995; 19: 47-50. Wald N, Morris J. What is case-finding? J Med Screening 1996; 3: 1. Ward J, Young J, Sladden M. General practitioners' views and use of tests to detect early prostate cancer. Aust N Z J Public Health 1998; 22: 374-380. Ward J, Hughes AM, Hirst G, Winchester L. Men's estimates of prostate cancer risk and self-reported rates of screening. Med J Aust 1997; 167: 250-253. Pinnock C, Weller D, Marshall V. Self-reported prevalence of prostate-specific antigen testing in South Australia: a community study. Med J Aust 1998; 169: 25-28. Sladden M, Dickinson J. General practitioners' attitudes to screening for prostate and testicular cancer. Med J Aust 1995; 162: 410-413. Ward J, Gupta L, Taylor N. Do general practitioners use prostate-specific antigen as a screening test for early prostate cancer? Med J Aust 1998; 169: 29-31. Hirst G, Ward J, Del Mar C. Prostate cancer screening: the case against. Med J Aust 1996; 164: 285-287. Whitmore W. Management of clinically localised prostate cancer: an unresolved problem. JAMA 1993; 269: 2676-2677. Gupta L, Ward J, Hayward R. Future directions for clinical practice guidelines: needs, lead agencies and potential dissemination strategies identified by Australian general practitioners. Aust N Z J Public Health 1997; 21: 495-499. Australian Health Technology Advisory Committee. Prostate Cancer Screening. Canberra: AGPS, 1996. Royal Australian College of General Practitioners. Guidelines for preventive activities in general practice. 4th ed. Sydney: RACGP, 1996; 26. Collins M, Fowler F, Roberts R, et al. Medical malpractice implications of PSA testing for early detection of prostate cancer. J Law Med Ethics 1997; 25: 234-242. SPSS for Windows [computer program]. Version 6.0. Chicago Ill: SPSS Inc, 1992. Commonwealth Department of Health and Family Services. General practice in Australia: supplementary tables 1997. Canberra: GP Branch, 1997; 19. (Publication no. 1838.) Gupta L, Ward J, Hayward R. Clinical practice guidelines in general practice: a national survey of recall, attitudes and impact. Med J Aust 1997; 166: 69-72. Hirst G. Clinical practice guidelines -- to what end? [letter]. Med J Aust 1997; 167: 288. Puech M, Ward J, Hirst G, Hughes AM. Local implementation of national guidelines: what do general practitioners suggest will work? Int J Qual Health Care 1998; 10: 339-343. Pelly JE, Newby L, Tito F, et al. Clinical practice guidelines before the law: sword or shield? Med J Aust 1998; 169: 330-333. (Received 7 Oct 1998, accepted 5 Jul 1999) Authors' details Needs Assessment and Health Outcomes Unit, Sydney, NSW. Seham Girgis, MB ChB, MPH, Public Health Officer; Jeanette E Ward, PhD, FAFPHM, Director, and Clinical Associate Professor, Department of Public Health and Community Medicine, University of Sydney. 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 1: Defining "screening" for prostate cancer "Screening" is defined as the testing of asymptomatic individuals to detect risk factors or preclinical disease which has not manifested itself clinically.8 A screening test must satisfy two major requirements to be considered worthwhile: The test must be able to detect the target condition earlier than without screening and not produce large numbers of false positive and false negative results; Screening for and treating persons with early disease should improve the likelihood of favourable health outcomes compared with treating patients when they present with signs or symptoms of disease.8 Community-based randomised controlled trials are in progress to assess whether prostate cancer screening reduces the risk of premature mortality from prostate cancer among men offered it.9 When the results of these trials are published in the peer-reviewed scientific literature, data with which to calculate men's mortality risk in the absence of screening and risk reduction in its presence will be publicly available. The absence of evidence of effectiveness of prostate cancer screening to reduce premature mortality explains why four Australian authorities have recommended against it. Until such evidence is available, "case finding" by GPs who order PSA tests and/or perform DREs on asymptomatic men inadvertently implies prostate cancer screening is worthwhile, even though its effectiveness is yet unproven.10 Inadequate efforts to disseminate evidence-based guidelines to Australian GPs compound this misguided clinical practice, now known to be incorporated at disturbingly high rates in preventive health check-ups.11 In the scenario used in our survey, a 58-year-old man presents to his regular GP after prompting by his wife to have a test for prostate cancer. Testing in this context equates with screening, irrespective that the man has requested it himself. Back to text 2: Tests recommended by general practitioners in response to a patient request before and after reading extracts from the national guidelines (n=219)Which test should be done?Which test would you do?BeforeAfterBeforeAfterDRE and PSA53%37%55%43%DRE alone31%19%28%18%PSA alone4%7%7%12%Neither10%32%6%19%†DRE = digital rectal examination. PSA = prostate specific antigen. *McNemar's χ2 = 47.02; P < 0.001. †McNemar's χ2 22.78; 1 df; P < 0.001. Bold indicates a response consistent with the national guidelines. Where columns do not add to 100%. Data are missing. Back to text3: General practitioners' perception of medicolegal risk before and after reading the guidelines (n=219BeforeAfterIs the GP at risk medicolegally if she or he does not perform either or both tests for screening?Yes61%46%No26%42%Unsure13%11%McNemar χ2=20.02; 1 df; P < 0.0001Is the GP at risk medicolegally is she or he does perform either or both tests for screening?Yes15%19%No69%62%Unsure16%18%McNemar χ2=4.05; 1 df; P = 0.041Given the three recommendations, is the GP protected medicolegally if she or he does not perform either or both tests for screening?Yes-28%No-33%Unsure-33%Bold indicates a response consistent with the national guidelines. Where columns do not add to 100%, data are missing. Back to text4: General practitioners' views about seven statements pertinent to prostate cancer screening (n=219)Strongly agreeAgreeUnsureDisagreeStrongly disagreePatients' decisions to be screened should be based on full disclosure of what is known about the diagnosis and treatment of early prostate cancer46%42%5%6%1%A positive PSA test result may cause unnecessary anxiety for the patients25%62%3%9%1%A GP could be sued for not ordering a PSA test for someone who subsequently develops cancer of the prostate.16%43%12%20%7%A positive PSA test result leads to investigations and treatments of unknown effectiveness10%44%14%27%3%A GP could be sued for ordering a PSA test for someone who subsequently experiences adverse consequences from treatment6%18%25%35%16%A positive PSA result will lead to investigations associated with unacceptable morbidity3%20%21%49%6%Patients should sign a 'consent form' explaining benefits and potential complications of PSA testing before the GP orders it7%14% 23%41%14%Where rows do not add to 100%, data are missing. Back to text 5: Percentage of respondents rating as "very important" 14 potential strategies to increase a sense of medicolegal protection (n=219) GuidelinesClear statement about the legal status of the guidelines in a court 65%That guidelines summarise any relevant medicolegal judgments44%Public educationPamphlets for patients about prostate cancer screening tests in languages other than English 49%Mass media campaign targeting men older than 50 years which reassures men that screening is ineffective44%A standard consent form explaining benefits and consequences of prostate-specific antigen screening which would need to be signed by the man before he has the test29%A standard consent form also available in languages other than English27%CourtsRequiring a peer expert GP as well as a specialist as expert witnesses66%Legislation that a false screening report does not of itself establish negligence59%Requiring all expert witnesses refer to evidence-based guidelines in court56%Requiring peer expert GPs instead of expert specialists as expert witnesses53%Expert panels to advise the judge instead of juries49%A system of "No fault compensation"46%Removing cases of malpractice from the adversarial legal system46%Juries to include members with medical backgrounds in medicolegal cases35% Back to text

Seham Girgis · Jeanette E Ward

For Debate Sex selection: the case for There is a strong argument in favour of sex selection, based on respect for procreative autonomy -- the autonomy of couples to decide for themselves how to procreate, and what children to have. Objections based on possible harm to the child, the parents, or society, are not compelling, particularly in Australia. Julian Savulescu MJA 1999; 171: 373-375 Introduction - Inconsistency - Harm - Procreative autonomy - Playing God - Conclusion - Acknowledgements - References - Authors' details - - More articles on Obstetrics & gynaecology and women's health Introduction Various methods now exist for attempting to choose to have a baby of a desired sex (see Box). With the recent advent of flow cytometric separation of X and Y sperm and preimplantation genetic diagnosis (PGD) (see Box), couples no longer have to employ abortion to select sex. Sex selection may therefore become more acceptable to some couples, and requests for clinics to provide it may become more common. In Australia, requests for medically assisted sex selection are not common; for example, one in-vitro fertilisation (IVF) clinic in Australia receives about 15-20 requests for sex selection each year (L Wilton, Consultant, Melbourne IVF, personal communication). Medically assisted sex selection for non-medical reasons is banned in the United Kingdom and Canada.7 In Australia, sex selection employing artificial insemination or IVF is banned explicitly in Victoria by section 50 of the Infertility Treatment Act 1995. In South Australia, section 13 of the Reproductive Technology Act 1988 requires that artificial fertilisation only be used for the treatment of infertility. Both Acts provide exceptions to avoid the risk of transmission of a genetic defect (assisted reproduction for medical reasons). In Australia, IVF clinics now offer PGD. One centre performs sex selection for non-medical reasons using IVF and PGD. This has been provided for fertile couples, but has been fully funded privately, costing couples around $10 000. So far, two boys and two girls have been born after sex selection for non-medical reasons (R Jansen, Medical Director, Sydney IVF, personal communication). In Victoria and South Australia, where it is illegal to perform PGD for sex selection, PGD to exclude aneuploidy may reveal the sex of embryos. Couples might in the future request "healthy" embryos of a desired sex -- "incidental sex selection". The legality of transferring embryos of a desired sex in this circumstance is not clear. Although many jurisdictions ban sex selection for non-medical reasons, there are a number of arguments in favour of allowing it. Inconsistency Paradoxically, it is legal to attempt periconceptual sex selection by "natural" means, even if these employ technology developed specifically for that purpose.7 Prenatal testing and termination of undesired-sex pregnancies is also accepted practice in some centres. It is inconsistent to provide couples with information from prenatal testing which allows them to select sex and not allow them to select sex by means which are more acceptable to them. Harm Harm to the child: The mutagenic risks of the sex selection procedure to children born must be evaluated.8 Many of the methods use well established procedures (such as IVF), though the long term consequences of some are not certain: these include PGD, intracytoplasmic sperm injection,9,10 and cryopreservation.11,12 Despite encouraging data from animal studies and existing human experience,13 there is a theoretical mutagenic risk associated with ultraviolet light and bisbenzimide used in sperm separation. Concerns about these risks should be addressed by scientific investigation and by ensuring that consent is properly informed, not by banning the procedure. Sex selection might also cause psychological harm if the procedure does not produce a child of the desired sex. However, parents inevitably have hopes and expectations for their children which are deflated every day. Most parents come to accept and love the child they have, even if that child has a serious disease or disability. Some parents want their children to be great musicians. Sometimes this desire becomes overbearing, as depicted in the film Shine. But the answer is not to ban music schools. The solution is to help parents to be more tolerant and accepting. Sex selection may be beneficial to the child born if parents will treat a child of that sex more favourably. However, it might be argued that the desire to select sex itself reflects a dysfunctional psychology. Furthermore, sex selection may allow people who are "unsuitable" to be parents to believe that they could cope with a child of a particular sex. It is dangerous to make such judgements about the "suitability" and the "functionality" of people as parents in the absence of any good evidence -- society is now rightly loath to enquire into people's fitness to parent. Moreover, preventing sex selection is no guarantee that such people, even if dysfunctional, will not have children. One objection in bioethics is that sex selection represents a violation of Kant's dictum never to use a person as a means, but always to treat him or her as an end. According to this argument, by selecting sex parents use their child to fulfil their own desires and fail to respect the child as a person. In one way this objection is fanciful. Parents have many desires related to their children: perhaps to have a companion, to have a friend to the first child, or to hold a marriage together. It is unlikely that any parent ever desires a child solely as an end in itself. Moreover, Kant's dictum is actually never to use a person solely as a means.14 Provided that parents love their child as an end in itself, there is no problem with the child's life also fulfilling some of the parents' desires for their own lives. Most importantly, without sex selection, without a unique sperm and egg uniting, that particular child would not have existed. Even if the child is disadvantaged psychologically, this is only wrong from the child's perspective if its life is so bad that it is not worth living. It is difficult to point to any life which can be judged from the outside to be not worth living (possible examples might include Lesch-Nyhan or Sanfilippo syndrome). Harm to other family members: It is hard to see how sex selection harms parents if they have a child of the desired sex; they may even benefit. If a parent will not be able to accept a child of a certain sex (say, a woman was sexually abused as a child and wants to have a girl), then it may be better for both parent and child if the parent selects sex. Another example might be parents who have one autistic boy. Autism is more common in boys but is not sex linked.15 Such parents might be happier with a girl. Could other siblings of the undesired sex be mistreated? Firstly, choosing to have a child of a certain sex does not imply that the other sex is undesired in other children. Secondly, treatment of children of the other sex will be largely determined by the pre-existing belief structure of parents. Social harm: Does sex selection represent a slide to eugenics and the creation of "designer babies"? We already allow parents to select the kind of children they have. Parents have enormous power (often unconscious) in shaping the kind of people their children become. Parents have the right to choose the environment according to what they believe is best for their child. Moreover, they are already allowed to choose what they believe will be the best children. Parents are allowed to use prenatal testing for disability -- even repairable disability such as cleft palate -- because they are allowed to decide whether they can accept that child. If parents can decide whether they can accept a child with cleft palate, they should be allowed decide whether they can accept a child of a given sex. Are women harmed by sex selection? Some critics claim that allowing sex selection implies that, in general, one sex is superior to the other16 -- to do so is sexist.17 According to Tonti-Filippini, it "devalues girls".2 However, it does not, any more than choosing to play Australian Rules football rather than soccer implies the former is "better" in some general sense. Boys and girls are different, and this difference matters to different families in different ways. Sex selection is more likely to harm women in Asia. There, sex selection is already common. The male-to-female ratio has risen to close to 1.2 in China18 and some urban parts of India.19 This situation has worsened since the advent of prenatal sex determination.8 It was estimated in 1990 that, globally, there are 100 million women "missing" (died prematurely) as a result of various forms of discrimination.20 It has been claimed that sex selection would "foster the already existing bias against the female child".8 Yet, even in Asia, it is not clear that sex selection should be banned.21 Disturbed sex ratios may not be a bad thing.22 Advantages which have been postulated include increase in influence of the rarer sex, reduced population growth and interbreeding of different populations.23 Most importantly, a false belief in the inferiority of women is not a product of sex selection -- sex selection is the product of that belief. Education and improving social and employment arrangements for women are more important in correcting these false beliefs than preventing sex selection. Consider an analogous argument: some disability advocates argue disability is a social construct; the lives of such people are made worse by the discriminatory attitudes of others.24 They argue prenatal testing serves to reinforce these attitudes and question whether it should be available for conditions like spina bifida.25,26 The community accepts that parents should be allowed to employ prenatal testing and selective termination to have a child without a disability, even if having a child with a disability would improve the plight of the disabled. By analogy, parents should be able to choose the sex of their child, even if not being able to choose the sex of their child would improve the plight of women. Procreative autonomy "Procreative autonomy" is the liberty to decide when and how to have children according to what parents judge is best.14 Parents know best their own circumstances, and ultimately it is parents who must live with and make sacrifices for their children. Procreative autonomy should not be sacrificed to correct social inequality. It is totalitarian for the State to dictate which children parents should have and rear. In the US, 90% of couples wanting sex selection wished to balance sex within the family. Parents were in their mid thirties, had two or three children and only wanted one more.1 In both the US and UK, just over half of couples choose a girl.27,28 Sex selection for family balancing would prevent, rather than contribute to, a disturbed sex ratio and harm to women. There is no risk of psychological harm to anyone with this kind of sex selection. Playing God Is selecting sex playing God? People have been playing God ever since they first decided to control which children they would have by abortion or by contraceptive use or abstinence. The fundamental question is: to what degree should parents be allowed to decide which children they will bear? Conclusion I have considered objections that sex selection might harm the child, other members of the family or society. Although, in a few cases, these objections may be valid, none is necessarily compelling in a country like Australia, where there will not be a systematic bias in favour of one sex across the whole community. The harm that might arise from sex selection is not of a degree sufficient to warrant State infringement of liberty. In my view, legislation in Victoria and South Australia should be changed to permit sex selection for balancing family sex. Acknowledgements The following people are thanked for critical comments on earlier drafts: Robert Jansen, Leeanda Wilton, Lach De Crespigny, John Rogers, Agnes Bankier, Mike Parker, Bob Williamson. References Fugger EF, Black SH, Keyvanfar K, Schulman JD. Births of normal daughters after Microsort sperm separation and intrauterine insemination, in-vitro fertilization, or intracytoplasmic sperm injection. Hum Reprod 1998; 13: 2367-2370. Carter H. Couple buy a baby girl to order. Herald Sun (Melbourne) 1998; Sept 12: 9. Carter H. Pick-the-sex test. Herald Sun (Melbourne) 1999; May 5: 5. Carter H. Baby sex selection method draws fire. Herald Sun (Melbourne) 1999; Jan 29: 4. Carson SA. Sex selection: the ultimate in family planning. Fertil Steril 1988; 50: 16-19. R v Davidson [1969] VR 667, Menhennitt J. Jansen RPS. Evidence based ethics and the regulation of reproduction. Hum Reprod 1998; 9: 2068-2075. Benagiano G, Bianchi P. Sex preselection: an aid to couples or a threat to humanity? Hum Reprod 1999; 14: 868-870. te Velde ER, van Baar AL, van Kooij RJ. Concerns about assisted reproduction. Lancet 1998; 351: 1529-1534. Bowen JR, Gibson FL, Leslie GI, Saunders DM. Medical and developmental outcome at 1 year for children conceived by intracytoplasmic sperm injection. Lancet 1998; 351: 1529-1534. Dulioust E, Toyama K, Busnel MC, et al. Long-term effects of embryo freezing in mice. Proc Natl Acad Sci USA 1995; 92: 589-593. Wennerholm UB, Albertsson WK, Bergh C, et al. Postnatal growth and health in children born after cryopreservation as embryos. Lancet 1998; 351: 1085-1090. Simpson JL, Carson SA. The reproductive option of sex selection. Hum Reprod 1999; 14: 870-872. Harris J. "Goodbye Dolly?" The ethics of human cloning. J Med Ethics 1997; 23: 353-360. Ralph I. Autism. N Engl J Med 1997; 337: 97-104. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Screening and counselling for genetic conditions. Washington, DC: US Government Printing Office, 1983; 58-59. Wertz DC, Fletcher JC. Ethics and human genetics: a cross cultural perspective. Heidelberg: Springer-Verlag, 1989. Zeng Y, Tu P, Gu BC, et al. Causes and implications of the recent increase in the reported sex ratios at birth in China. Pop Dev Rev 1993; 19: 283-302. Registrar General of India. Census of India 1991. Final population totals. Series I. India, Paper 2. New Delhi: Registrar General and Census Commissioner, 1992. Sen A. More than 100 million women are missing. New York Review of Books 1990; Dec 20; 61. Young R. The ethics of selecting for fetal sex. Ballieres Clin Obstet and Gynaecol 1991; 5: 576-590. Singer P, Wells D. The reproduction revolution. Oxford: Oxford University Press, 1984; 171. Sureau G. Gender selection: a crime against humanity or the exercise of a fundamental right? Hum Reprod 1999; 14: 867-868. Newell C. The social nature of disability, disease and genetics. J Med Ethics 1999; 25: 172-175. Davis A. From where I sit. London: Triangle, 1989; 19. Davis A. Yes, the baby should live. New Scientist 1985; Oct 31: 54. Batzofin JH. XY sperm separation for sex selection. Urological Clinics of North America 1987; 14: 609-618. Lui P, Rose GA. Social aspects of over 800 couples coming forward for gender selection of their children. Hum Reprod 1995; 10: 968-971. Authors' details Royal Children's Hospital, Melbourne, VIC. Julian Savulescu, MB BS, PhD, Director, Ethics Unit, Murdoch Institute, and Director, Ethics Program, Centre for the Study of Health and Society, University of Melbourne. Reprints will not be available from the author. Correspondence: Associate Professor J Savulescu, Murdoch Institute, Royal Children's Hospital and Centre for the Study of Health and Society, University of Melbourne, Parkville, VIC 3052. savulesjATcryptic.rch.unimelb.edu.au Methods of sex selection Preconceptual The most reliable preconceptual method of sex selection is flow cytometric separation of X and Y sperm.1 This technique provides couples with a five- to six-times greater chance of having a girl rather than a boy.1 It is about 85% effective at producing a girl, and 65% effective in producing a boy. One child was born using this method in Sydney,2 but it is no longer employed (R Jansen, Medical Director, Sydney IVF, personal communication). Periconceptual Periconceptual choice of sex is based on the observation that conception close to ovulation is more likely to result in a boy. Attempts to predict the time of ovulation have been made by measuring hormonal levels,3 polarity of the egg membrane,4 and cervical mucus thickness. Other "folk" methods include positioning during intercourse, vaginal douching, and so on.5 These methods are commonly employed throughout the world, but the effectiveness of periconceptual methods has not been well documented. Postconceptual Postconceptual medically assisted sex selection is possible by in-vitro fertilisation (IVF) and preimplantation genetic diagnosis (PGD), or by employing prenatal testing (chorionic villus sampling, amniocentesis, ultrasound) and termination of pregnancy, or infanticide. The most accessible reliable method is chorionic villus sampling (CVS) at about 11 weeks' gestation, followed by abortion if the fetus is not of the desired sex. Although CVS for sex selection is not accepted by any professional body and CVS is not routinely offered for sex selection, some clinicians will provide it; at any rate, couples can access CVS if they are concerned about possible chromosomal abnormalities. In practice, at 11 weeks' gestation couples are free to choose to terminate a pregnancy on any grounds, though legislation in all States imposes some constraints. For example, the Menhennitt ruling in Victoria requires that abortion protect the woman from serious danger to her life or health.6 Preimplantation genetic diagnosis (PGD) provides an alternative which does not require abortion. It requires IVF and intracytoplasmic sperm injection. Embryo biopsy, removing one or two cells, is performed on Day 3 at the 8-cell stage. PGD can be used to detect chromosomal abnormalities (by fluorescence in situ hybridisation [FISH]) and single gene disorders such as cystic fibrosis or haemophilia (by DNA probe or polymerase chain reaction amplification of specific DNA sequences). In Australia, there are two FISH kits currently in use: one tests for chromosomes 13, 16, 18, 21, 22 and the other for 13, 18, 21, X and Y. FISH can thus be used for embryo sexing. Testing takes one day. Back to text

Julian Savulescu