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Journal of Public Health Advance Access originally published online on October 23, 2006
Journal of Public Health 2006 28(4):309-317; doi:10.1093/pubmed/fdl066
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© The Author 2006, Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved.

Informed choice in screening programmes: Do leaflets help? A critical literature review



Rosemary Fox, Specialist Registrar
National Public Health Service for Wales, Temple of Peace and Health Cathays Park, Cardiff CF10 3NW, UK

Address correspondence to Rosemary Fox, E-mail: rosemary.fox{at}nphs.wales.nhs.uk

Background Screening programmes aim to maximise population benefit by maximizing uptake but must also allow informed choice about participation. Many programmes provide potential participants with information leaflets. This article reviews studies of the effectiveness of leaflets in promoting informed choice in screening.

Methods I searched 15 electronic databases and the websites of UK screening programmes, searched the bibliographies of identified studies and contacted experts in the field. Randomized controlled trials (RCTs) and controlled clinical trials where an attempt had been made to determine the contribution of leaflets to the exercise of informed choice in screening decisions were included.

Results I identified nine trials from various screening programmes. Outcome measures included knowledge, attitudes to screening, intention to be screened, uptake, anxiety, satisfaction with decision-making, discussions about screening with care providers and agreement that enough information had been provided to allow informed choice. Most studies demonstrated that providing written information increased knowledge, but evidence that this promoted informed choice was poor.

Conclusions Research into informed choice in screening is hampered by the lack of agreement about its definition and measurement. The most effective way for screening programmes to achieve informed choice is unclear. Programmes should not rely solely on providing written information but should explore additional ways to promote informed choice.

Keywords: decision making, informed choice, leaflets, pamphlets, screening


   Introduction
TOP
 Introduction
Methods
 Results
 Discussion
 Conclusion
 References
 
Screening programmes traditionally aim to maximise effectiveness and cost-effectiveness by maximizing uptake. In recent years, the imperative to ensure that prospective participants can make informed choices about entering screening programmes has emerged. General Medical Council guidance on consent to screening states:

‘you must ensure that anyone considering whether to consent to screening can make a properly informed decision... you should explain carefully the purpose of screening; the likelihood of positive or negative findings and the possibility of false positive or negative results; the uncertainties and risks attached to the screening process; any significant medical, social, or financial implications of screening and follow up plans, including the availability of counselling and support’.1

The concept of ‘informed choice’ has proved difficult to define and measure. One commonly used definition:

‘choice that is informed, consistent with the decision-maker’s values and behaviourally implemented’2

leaves unanswered the question of what it is to be ‘informed’. Simply having been provided with information is insufficient.3 The information must be understood, and it should be framed in a way that does not suggest there is a ‘right’ or a ‘wrong’ choice.4,5

Few studies of decision-making processes have been carried out,6,7 and validated measures of informed choice in screening are rare, programme-specific and unsuitable for general use.8 Although screening programmes are obliged to ensure that participants can make informed choices, it is unclear how they can best achieve this or evaluate their success in doing so.

Information provision is clearly necessary for the exercise of informed choice. Most screening programmes provide prospective users with written information in the form of leaflets. Although these provide a reasonably inexpensive way to deliver information, they have been criticized for concentrating on the benefits of screening without providing enough information to allow informed choice.3,9–11 Leaflets are more likely to be provided to the articulate3 and are unhelpful to those with poor literacy. It is currently unclear whether the provision of leaflets facilitates informed choice.

This study summarizes a critical literature review carried out to assess the usefulness of leaflets in promoting informed choice in screening.


   Methods
TOP
 Introduction
 Methods
Results
 Discussion
 Conclusion
 References
 
Search strategy
The search strategy is reproduced in the Appendix. It was developed following preliminary searches using various MESH subject headings. Most terms were not included in the final search strategy as they did not increase search sensitivity.

I searched electronic databases of medical (Medline 1966–2006 and Embase 1980–2006) and nursing (CINAHL 1982–2006 and British Nursing Index 1985–2006) literature and evidence-based medicine resources (The Cochrane library, NHS CRD). I searched the websites of UK screening programmes, the National Screening Committee and National Institute for Health and Clinical Excellence (NICE). I searched the bibliographies of identified studies, hand searched the Journal of Medical Screening 1995–2005 and contacted experts in the field to identify studies missed by the original search. The search was validated by performing a search using search terms from Cochrane reviews of the determinants of screening uptake12 and the influence of information provision on screening uptake.9 No additional papers suitable for inclusion were identified.

Selection criteria
I included English language publications of randomized controlled trials (RCTs) and controlled clinical trials that had attempted to determine the contribution of leaflets to the exercise of informed choice in screening decisions. I included all screening programmes. I excluded trials that concentrated on children, and on personalized risk communication, or where the only outcome measures were increased knowledge about screening or increased screening uptake.

Appraisal criteria
I developed criteria for appraising selected articles using a standard critical appraisal proforma13 and review articles on informed consent for screening9,12 (Table 1).


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  		Table 1 Systematic appraisal criteria

 


   Results
TOP
 Introduction
 Methods
 Results
Discussion
 Conclusion
 References
 
The search identified 264 articles. Nine studies met the inclusion criteria (Table 2). All were RCTs. Study quality was variable. Only one study met all the quality criteria (Table 3). Five studies described the randomization method; four stated that assessors were blinded to the intervention and two used intention to treat analysis. Five included power calculations, including one in which the required sample size was not reached. All contained sufficient information about the intervention to allow assessment of the information provided. The intervention material included information on the risks and benefits of screening in all.


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  		Table 2 Selected studies: description and main results

 

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  		Table 3 Study quality

 

Prostate cancer screening
Schapira and Van Ruiswyk14 reported small (although statistically significant) increases in knowledge in men receiving either a basic prostate cancer leaflet or an illustrated decision aid. Screening uptake was similar in both groups. There was no evaluation of decisional conflict or satisfaction with the decision-making process.

Wilt et al.15 found significantly increased knowledge in men randomized to receive a mailed leaflet describing the risks and benefits of prostate cancer screening, detection and treatment, compared with those receiving usual care. There were no significant differences in attitudes to screening, discussions with a doctor about screening or screening uptake in the following year. This study used discussion with a doctor as a proxy for active decision-making. There was no evaluation of the content or adequacy of those discussions, decisional conflict or satisfaction with the decision-making process.

Partin et al.16 found no difference in knowledge between men receiving a mailed leaflet or video on prostate cancer screening and those receiving usual care. Men receiving the leaflet were significantly more likely than controls to discuss screening with their doctor and less likely to intend to be screened. Actual screening uptake in the next year did not differ between groups. Again, discussion with a doctor was used as a proxy for active decision-making. Decisional conflict and satisfaction with the decision-making process were not examined.

Gattellari and Ward17 compared men receiving an evidence-based booklet containing quantitative information and ‘content previously identified by experts as essential to informed decision-making’ with those receiving conventional information. After receiving the booklets, both groups had significantly improved knowledge compared with baseline. Men who received the evidence-based booklet were significantly more likely to believe they could make an informed choice about screening than those receiving the control leaflet. Both groups displayed less positive attitudes to screening after the intervention and had less intention to be screened with no significant difference between the groups.

Gattellari and Ward18 reported significantly increased knowledge and less favourable attitudes towards screening in men who received a basic prostate cancer information leaflet, a video on the natural history of prostate cancer or an evidence-based booklet. (The effect was most marked in men receiving the evidence-based booklet.) There were no significant differences between the groups in decisional uncertainty, intention to be screened in the following 12 months or worry about prostate cancer. Ninety-one per cent of men receiving the standard leaflet and 90% men receiving the evidence-based booklet believed that they could make an informed choice. Over 40% men in all groups felt that the information was advocating screening. This was most apparent in the group receiving the simple leaflet.

Antenatal screening
Kirkham and Stapleton19 conducted a cluster RCT of the effectiveness of evidence-based midwifery care leaflets designed to promote informed choice, compared with usual care. Two leaflets dealt with screening (ultrasound screening for foetal abnormality and serum screening for Down’s syndrome and spina bifida). The analysis allowed the effect of individual leaflets to be evaluated. There was no significant difference in the proportion of women in either group feeling they had been given sufficient information to make an informed choice.

Michie et al.20 found no significant differences in knowledge, anxiety, decision-making or uptake of Down’s syndrome screening in pregnant women randomized to receive a simple leaflet, simple leaflet and video, an expanded leaflet or expanded leaflet plus video.

Genetic screening
Schwartz et al.21 found a significantly greater increase in knowledge and perception of the risks of testing for BRCA1/BRCA2 mutation in high-risk women who received a genetic testing leaflet compared with controls given general breast cancer information. There was no significant difference in perceptions of the benefits of screening or intention to be screened.

Pancreatic cancer screening
Domenighetti et al.22 compared willingness to undergo pancreatic cancer screening in Swiss adults receiving basic or extended information.

Significantly fewer participants receiving the extended information were willing, in theory, to accept the test. Participants were not offered testing, so no uptake data are available. Decisional conflict and satisfaction with the decision-making process were not examined.


   Discussion
TOP
 Introduction
 Methods
 Results
 Discussion
Conclusion
 References
 
Main findings
These studies provide some evidence that provision of written information improves knowledge about screening. Of the seven studies with knowledge as an outcome measure, five showed significantly increased knowledge in the intervention group compared with controls.141516171821 The evidence that written information promotes informed choice is unconvincing: in one study, >40% men in all groups felt that the information was advocating screening.18 Six studies included some analysis of decision-making. Four found no difference between intervention and control groups,1518–20 in one, the intervention group was more likely to discuss screening with their doctor,16 and in one, the intervention group was more likely to feel they could make an informed choice.17

Might informed choice affect screening uptake? Five studies compared intention to be screened.16–18,21,22 In one, the intervention group displayed less desire for screening than the controls.22 None of the four studies with screening uptake as an outcome measure found any effect of the intervention.14–16,20

What is already known on this topic
Although there is general agreement that informed choice for participants in screening programmes is both desirable and necessary, the definition of informed choice is unsatisfactory, and little information exists on its measurement or effect. Although knowledge can be easily measured, it cannot be assumed to lead to informed choices, as both decision-making and putting decisions into practice are complex processes affected by factors internal and external to the individual, which may change over time.

Anticipated benefits of informed choice include encouragement of realistic expectations of screening, facilitation of open debate about screening programmes and a reduction in the false reassurance or anxiety provided by false negative or positive results.23,24

Alternatively, it has been suggested that informed choice could lead to reduced screening uptake, effectiveness and cost-effectiveness. Inequalities in health could widen as the most disadvantaged may be most likely to be deterred.23 Currently, no evidence exists to confirm or refute these hypotheses,9 and few studies of the decision-making process have been carried out.6,7

What this study adds
The studies included here provide some evidence that leaflets can increase knowledge of complex systems such as screening. The evidence that this facilitates the exercise of informed choice is much less reassuring. Of the five studies where knowledge of screening increased in the intervention group, screening uptake was unaffected in two14,15 and intention to be screened unaffected in three.17,18,20 One study compared intention to be screened with actual screening uptake: although intention to be screened was lower in the intervention group than the controls, uptake was unaffected.16

Limitations of the study
The definition and measurement of informed choice remain problematic. Although all the studies in this review met the criteria for considering informed choice,12 it was clear that authors’ interpretations differed.

Only RCTs were included in the review, providing the highest quality evidence available. Although trials of public health interventions are more complex than those of interventions such as medicines, there are many examples of carefully designed studies of complex interventions which have provided good quality evidence of effectiveness (or lack of it).

The interventions in the studies presented here were, in fact, relatively simple, but comparison is hampered as the studies relate to four different contexts (antenatal screening,19,20 screening for prostate cancer,14–18 pancreatic cancer22 or genetic mutation21). Even where the condition studied was the same, for example the five studies of prostate cancer screening, the studies used different interventions, and controls and outcome measures varied.

Comparison of the studies involving different conditions is even more difficult. For example, it is possible that the decision-making process for antenatal screening, which is accepted as routine by many women, is quite different from that for prostate cancer screening, where it is widely known that screening is controversial. It may be that the notion of informed choice may be misleading, at least for antenatal screening, with uptake being normative behaviour rather than a choice.

Five studies had participation rates of <65%.1415172021 In two, participants differed substantially from the non-participants,20,21 limiting the generalizability of the results. No details were provided about non-participants in three of the remaining studies,14,15,17 whereas in one, they were said to be younger than, but otherwise similar to, participants.18

Finally, most of the studies may have been underpowered. However, of the four studies that had a power calculation and achieved their desired sample size, none demonstrated a significant effect from the intervention.14161819


   Conclusion
TOP
 Introduction
 Methods
 Results
 Discussion
 Conclusion
References
 
The literature review suggests that screening programmes should not rely on the routine provision of written information to ensure prospective users can make informed choices about participation. Even where such information has been specifically designed to promote informed choice, the evidence that it achieves this is poor. Although it is unlikely that programmes will wish to stop providing written information altogether, relying entirely on pamphlets will not provide potential participants with the opportunity to make truly informed choices.

Programmes should consider other ways of providing prospective participants with the information they need to make informed choices, for example tailored information, web-based decision aids or semi-structured discussion.

The implementation of such approaches should be evaluated to determine whether they are an improvement on the current situation.

Interpretation of such evaluation would be facilitated by the development of an agreed definition of informed choice and of standardized outcome measures to allow comparisons between methods to be drawn.


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  		Appendix: Search strategy

 


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  		Unhelpful search terms

 

   References
TOP
 Introduction
 Methods
 Results
 Discussion
 Conclusion
 References
 
  1. General Medical Council. Seeking Patients’ Consent: The Ethical Considerations. Web. 1998. (16 November 2005, date last accessed).
  2. Jepson RG, Hewison J, Thompson AGH et al. How should we measure informed choice? The case of cancer screening. J Med Ethics 2005;31:192–6.[Abstract/Free Full Text]
  3. Kirkham M, Stapleton H. Executive summary. In: Kirkham M, Stapleton H (eds). Informed Choice in Maternity Care: An Evaluation of Evidence Based Leaflets. NHS Centre for Reviews and Dissemination, University of York, 2001.
  4. Williams C, Alderson P, Farsides B. Too many choices? Hospital and community staff reflect on the future of prenatal screening. Soc Sci Med 2002;55:743–53.[CrossRef][Web of Science][Medline]
  5. Safarti D, Howden-Chapman P, Woodward A et al. Does the frame affect the picture? A study into how attitudes to screening for cancer are affected by the way benefits are expressed. J Med Screen 1998;5:137–40.[Abstract/Free Full Text]
  6. Jepson RG, Forbes CA, Sowden AJ et al. Increasing informed uptake and non-uptake of screening: evidence from a systematic review. Health Expect 2001;4:116–26.[CrossRef][Medline]
  7. Edwards A, Unigwe S, Elwyn G et al. Personalised risk communication for informed decision making about entering screening programmes. Cochrane Database Syst Rev 2003:1.
  8. Marteau TM, Dormandy E, Michie S. A multi-dimensional measure of informed choice. Health Expect 2001;4:99–108.[CrossRef][Medline]
  9. Broclain D, Jepson R, Moumjid Ferdjaoui N. Influence of comprehensive versus partial information on consumers’ screening choices. Cochrane Database Syst Rev 2003.
  10. Dixon-Woods M. Writing wrongs? An analysis of published discourses about the use of patient information leaflets. Soc Sci Med 2001:1417–32.
  11. Jorgensen KJ, Gotzsche PC. Content of invitations for publicly funded screening mammography. BMJ 2006;332:538–41.[Free Full Text]
  12. Jepson R, Clegg A, Forbes C et al. The determinant of screening uptake and interventions for increasing uptake: a systematic review. Health Technol Assess 2000;4:1–133.[Medline]
  13. CASP. Web. 2006. (1 August 2005, date last accessed).
  14. Schapira MM, Van Ruiswyk J. The effect of an illustrated pamphlet decision-aid on the use of prostate cancer screening tests. J Fam Pract 2000;49:418–24.[Web of Science][Medline]
  15. Wilt TJ, Paul J, Murdoch M et al. Educating men about prostate cancer screening. A randomized trial of a mailed pamphlet. Eff Clin Pract 2001;4:112–20.[Medline]
  16. Partin MR, Nelson D, Radosevich DNS et al. Randomized trial examining the effect of two prostate cancer screening educational interventions on patient knowledge, preferences and behaviors. J Gen Intern Med 2004;19:8–835.[Web of Science][Medline]
  17. Gattellari M, Ward JE. Does evidence-based information about screening for prostate cancer enhance consumer decision-making? A randomised controlled trial. J Med Screen 2003;10:27–39.[CrossRef][Web of Science][Medline]
  18. Gattellari M, Ward JE. A community based randomised controlled trial of three different educational resources for men about prostate cancer screening. Patient Educ Couns 2005; 57:168–82.[CrossRef][Web of Science][Medline]
  19. Kirkham M, Stapleton H (eds). The MIDIRS informed choice leaflets in the context of clinical practice. Informed Choice in Maternity Care: An Evaluation of Evidence Based Leaflets. NHS Centre for Reviews and Dissemination, University of York, 2001.
  20. Michie S, Smith D, Mclennan A et al. Patient decision making: an evaluation of two different methods of presenting information about a screening test. Br J Health Psychol 1997;2:317–26.[Web of Science]
  21. Schwartz MD, Benkendorf J, Lerman C et al. Impact of educational print materials on knowledge, attitudes and interest in BRCA1/BRCA2: testing among Ashkenazi Jewish women. Cancer 2001;92:932–40.[CrossRef][Web of Science][Medline]
  22. Domenighetti G, Grilli R, Maggi JR. Does provision of an evidence-based information change public willingness to accept screening tests? Health Expect 2000;3:145–50.[CrossRef][Medline]
  23. Raffle AE. Information about screening—is it to achieve high uptake or ensure informed choice? Health Expect 2001;4:92–8.[CrossRef][Medline]
  24. Marshall T, Adab P. Informed consent for breast screening: what should we tell women? J Med Screen 2003;10:22–6.[CrossRef][Web of Science][Medline]

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